Art.

no: 0-48-0366 Rev: g *0-48-0366*

User Guide
DEFIGARD HD-7
 Sales and Service Information
The SCHILLER sales and service centre network is world-wide. For the address of your
local distributor, contact your nearest SCHILLER subsidiary.

In case of difficulty, you can find a complete list of all distributors and subsidiaries on our
Internet site:

http://www.schiller.ch

Sales information can also be obtained from:

sales@schiller.ch

Manufacturer
SCHILLER MEDICAL Phone +33 3 88 63 36 00
4, rue Louis Pasteur Fax +33 3 88 94 12 82
F- 67160 Wissembourg Email: info@schiller.fr
Web: www.schiller-medical.fr

Art. no./revision: Date Note

0-48-00366a 17.01.2020 Initial version
Update with new accessory defibrillation
0-48-00366b 17.12.2020 spoons and some other minor
corrections
0-48-00366c
5.04.2022 Removed sentence below section 1.13.4

Update according to MDR requirements

Add new cybersecurity, safety guidelines
in section 1.11
Add new appendix symbol and re-
0-48-00366d
arranged section 1.13.2
Add new warnings in 5.1 and 5.1.1
Update accessories list
Some other minor changes.
0-48-00366e 27.09.2023 Update according to MDR requirements
0-48-00366f 06.03.2024 Update according to MDR requirements
0-48-00366g 14.05.2024 Update according to MDR requirements

The DEFIGARD HD-7 bears the CE-0459 mark (Notified Body GMED), indicating its compliance
with the essential requirements of Annex IX of Directive 93/42/EEC. The requirements apply to
patients, users, and third persons who come into contact with this device within the scope of its
intended use.

The safety and clinical performance summary are available on the EUDAMED website.

Article no.: 0-48-0366 Rev: g

Issue date: 14.05.2024
Translation: Original

SW ≥ 2.x
 DEFIGARD HD-7 User guide

Table of Contents
1 Safety Notes .............................................. 9
1.1 User Profiles ......................................................................... 9
1.2 Intended Use ....................................................................... 10
1.3 Medical Indications ............................................................ 11
1.3.1 Manual mode (ACLS user)............................................................... 11
1.3.2 AED Mode (ACLS or BLS user) ....................................................... 12
1.3.3 Monitoring ........................................................................................ 12
1.4 Expected Therapeutic Clinical Patients Benefits ............ 12
1.4.1 Cardiac arrest................................................................................... 12
1.4.2 Non-lethal arrhythmia....................................................................... 13
1.4.3 Open-chest surgeries....................................................................... 13
1.4.4 Patients with signs of bradycardia (syncope)................................... 13
1.5 Expected Patient Monitoring Clinical Benefits ................ 13
1.5.1 6-lead ECG monitoring..................................................................... 14
1.5.2 NIBP monitoring ............................................................................... 14
1.5.3 SpO2 monitoring .............................................................................. 14
1.5.4 EtCO2 and RR monitoring ............................................................... 14
1.6 Contraindication For Use................................................... 15
1.6.1 Monitoring ........................................................................................ 15
1.7 Known Side Effects ............................................................ 15
1.7.1 Monitoring ........................................................................................ 16
1.8 Responsibility of the User ................................................ 16
1.9 Organisational Measures ................................................... 16
1.10 Safety Conscious Operation ............................................. 17
1.11 Operation with other Devices ............................................ 18
1.12 Maintenance........................................................................ 19
1.13 Hygiene................................................................................ 19
1.14 Cybersecurity...................................................................... 19
1.14.1 Networks and the internet ................................................................ 19
1.14.2 Patient data (personal data)............................................................. 20
1.15 Additional Terms ................................................................ 20
1.15.1 Implied authorisation ........................................................................ 20
1.15.2 Terms of warranty ............................................................................ 20
1.15.3 Reporting serious incident disclosure policy .................................... 21
1.15.4 Reporting security incidents and vulnerability disclosure policy....... 21
1.15.5 Additional information....................................................................... 21
1.16 Display Symbols and Indicators ....................................... 21
Art. no: 0-48-0366 Rev: g

1.16.1 Symbols used in this user guide ...................................................... 21

1.16.2 Symbols used on the device ............................................................ 22
1.16.3 Symbols used on the electrode package ......................................... 24

2 Components and Operation .................. 25

2.1 Design.................................................................................. 25
2.1.1 Standard unit and options ................................................................ 26
2.2 Operating Elements............................................................ 27
2.2.1 Front panel DEFIGARD HD-7.......................................................... 27
2.2.2 Back panel ....................................................................................... 28
2.2.3 LEDs ................................................................................................ 28
2.2.4 Display ............................................................................................. 29

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 DEFIGARD HD-7

3 Initial Operation ......................................30

3.1 Mains Supply and Battery Operation................................ 30
3.1.1 Mains supply and charging battery .................................................. 30
3.1.2 Battery Operation............................................................................. 31
3.1.3 Charging the battery ........................................................................ 31
3.2 Switching Off, disconnecting from the Mains Supply..... 32
3.2.1 Internal safety discharge.................................................................. 32
3.2.2 Interruption of the mains supply....................................................... 32
3.2.3 Ensuring operational readiness ....................................................... 33
3.3 Operation............................................................................. 34
3.4 Patient Data ......................................................................... 35
3.4.1 Patient Data Query (PDQ) (Optional) .............................................. 35
3.4.2 Worklist (optional) ............................................................................ 37
3.5 Printing ................................................................................ 38
3.5.1 Changing printing paper................................................................... 39
3.6 Trolley .................................................................................. 40

4 Monitoring ...............................................41
4.1 Soft keys, Waveforms and Measurement Fields ............. 41
4.1.1 View selection .................................................................................. 42
4.2 Alarm System...................................................................... 43
4.2.1 Alarm priority.................................................................................... 43
4.2.2 Operator’s position........................................................................... 43
4.2.3 Alarm list .......................................................................................... 44
4.2.4 Pausing, switching off or reactivating audio alarms ........................ 44
4.3 Operator Defined Alarm Thresholds................................. 45
4.3.1 Table of default threshold setting..................................................... 46
4.3.2 Table of wide and narrow threshold setting ..................................... 47
4.4 ECG and HR Monitoring..................................................... 48
4.4.1 Quick diagnosis of the ECG using defibrillation electrodes ............. 48
4.4.2 Connecting a 4-wire ECG patient cable........................................... 49
4.4.3 Starting ECG monitoring .................................................................. 49
4.4.4 Monitoring a pacemaker patient....................................................... 50
4.4.5 Curve list .......................................................................................... 52
4.4.6 HR Module (ECG) settings .............................................................. 52
4.4.7 ECG Messages................................................................................ 52
4.5 Long ECG Recording ......................................................... 53
4.6 SpO2 Monitoring (Option) .................................................. 54
4.6.1 Inaccurate or incorrect measurement results................................... 57
4.6.2 Starting SpO2 monitoring and test................................................... 58
4.6.3 SpO2 Module Masimo set................................................................ 59
4.6.4 SpO2 Module Nellcor....................................................................... 59
Art. no: 0-48-0366 Rev: g

4.6.5 Masimo set error and information messages .................................... 59

4.6.6 Nellcor SpO2 error and information messages ................................. 61
4.7 NIBP Monitoring.................................................................. 63
4.7.1 Procedure for good NIBP measurements ........................................ 65
4.7.2 Paediatric and neonate considerations............................................ 65
4.7.3 Hypertensive considerations............................................................ 65
4.7.4 Starting NIBP monitoring ................................................................. 66
4.7.5 NIBP Menu....................................................................................... 67
4.7.6 NIBP Information and error messages............................................. 67
4.8 CO2 Sidestream .................................................................. 68
4.8.1 ISA gas analyser (sidestream measurement).................................. 68
4.8.2 Initial operation of the ISA gas analyser .......................................... 70

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 DEFIGARD HD-7 User guide

4.8.3 Sensor LED indications.................................................................... 70

4.8.4 Nomoline family sampling line (water trap) replacement ................. 71
4.8.5 RR alarms and messages................................................................ 71
4.8.6 Settings EtCO2 menu ...................................................................... 72
4.8.7 Curve list .......................................................................................... 72
4.8.8 Zeroing of the CO2 sidestream sensor ............................................ 72
4.9 Registering Events ............................................................. 73
4.10 View Trends, Events and Screenshots............................. 73
4.10.1 View trends ...................................................................................... 73
4.10.2 View, print and transmit screenshots ............................................... 74
4.10.3 View and print events....................................................................... 74

5 Defibrillation ........................................... 76
5.1 Application Guidelines and Safety Notes ........................ 76
5.1.1 Additional safety information for AED mode .................................... 77
5.1.2 Additional safety information for internal defibrillation (spoons)....... 77
5.1.3 Defibrillating children/neonates ........................................................ 78
5.2 General Function ................................................................ 80
5.2.1 Activating the manual defibrillation mode......................................... 81
5.2.2 Activating the automated (AED) defibrillation mode......................... 81
5.2.3 AED layouts ..................................................................................... 83
5.2.4 Manual defibrillation procedure ........................................................ 83
5.3 Manual Defibrillation using Paddles ................................. 84
5.4 Manual Defibrillation using Spoons ................................. 86
5.4.1 Manual defibrillation procedure using spoons.................................. 87
5.5 Defibrillation using Pads ................................................... 89
5.5.1 Adult and paediatric electrodes........................................................ 89
5.5.2 Applying the electrodes.................................................................... 90
5.5.3 Connecting pads to the device......................................................... 91
5.5.4 Checking the electrodes................................................................... 91
5.6 Synchronised Defibrillation............................................... 92
5.6.1 Warning erroneous triggering........................................................... 92
5.6.2 Setup switching from synchronised to asynchronised mode ........... 92
5.6.3 Function of the synchronised defibrillation procedure...................... 93
5.6.4 Synchronised defibrillation procedure .............................................. 94
5.7 Semi-automated Defibrillation (AED)................................ 95
5.7.1 Semi-automated defibrillation procedure ......................................... 95
5.7.2 Voice messages in AED mode......................................................... 96
5.7.3 Defibrillation procedure .................................................................... 97
5.8 CPR ...................................................................................... 98
5.8.1 SCHILLER LifePoint......................................................................... 98
5.8.2 FreeCPR ........................................................................................ 100
5.8.3 Metronome settings........................................................................ 100
Art. no: 0-48-0366 Rev: g

5.9 Defibrillator Technical Messages.................................... 100

6 Pacemaker ............................................ 102

6.1 Pacemaker Function ........................................................ 102
6.1.1 Fixed-rate mode (Fix)..................................................................... 102
6.1.2 Demand mode................................................................................ 103
6.2 Safety Notes...................................................................... 103
6.3 Guidelines for the Application of External Pacemakers 103
6.3.1 Attaching the pacer pads ............................................................... 104
6.3.2 Checking the electrodes................................................................. 105

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 DEFIGARD HD-7

6.4 Start-up of the Pacemaker ............................................... 105

6.4.1 Pacemaker display......................................................................... 105
6.4.2 Selecting pacemaker mode ........................................................... 106
6.4.3 Pacemaker settings operational Fixed mode................................. 107
6.4.4 Demand mode ............................................................................... 108

7 Finishing the Therapy ..........................109

8 Data Management .................................110

8.1 Intervention data............................................................... 110
8.1.1 Start and stop intervention ............................................................. 111
8.1.2 Review, print and transmit intervention data.................................. 111
8.1.3 Selecting communication media .................................................... 112
8.2 Patient Data Information .................................................. 113
8.2.1 Patient Data Query (PDQ) (Optional) ............................................ 113
8.2.2 PDQ in Worklist (Optional)............................................................. 113
8.3 Technical Data .................................................................. 113
8.3.1 Self-test review and transmitting.................................................... 113
8.3.2 Logfiles........................................................................................... 114

9 Main Menu .............................................115

9.1 General Setup ................................................................... 115
9.1.1 Device settings menu .................................................................. 116
9.1.2 Test setting menu .......................................................................... 116

10 Maintenance ..........................................118
10.1 Maintenance Interval ........................................................ 118
10.1.1 Maintenance interval table ............................................................. 118
10.1.2 Service and shelf life...................................................................... 119
10.2 Functional Test ................................................................. 119
10.2.1 Visual inspection of the device and accessories............................ 119
10.2.2 Battery check ................................................................................. 119
10.2.3 Defibrillator shock test.................................................................... 120
10.2.4 Self-test.......................................................................................... 120
10.2.5 Functional test - measured value................................................... 121
10.2.6 Alarm tests ..................................................................................... 122
10.3 Update Software ............................................................... 122
10.3.1 Access the menu control panel...................................................... 123
10.3.2 Update via USB ............................................................................. 123
10.3.3 Update via a server........................................................................ 123
10.4 Maintenance interval of the batteries ............................. 124
10.4.1 Replacing the batteries .................................................................. 124
Art. no: 0-48-0366 Rev: g

10.4.2 Putting the device in transport mode ............................................. 124

10.4.3 Battery disposal ............................................................................. 124
10.4.4 Residual risk with rechargeable battery ......................................... 125
10.5 Cleaning............................................................................. 125
10.5.1 Detergents ..................................................................................... 125
10.6 Disinfection ....................................................................... 126
10.6.1 Disinfectant .................................................................................... 126
10.6.2 Cleaning and disinfecting the device, cable and sensors .............. 126
10.6.3 Spoon electrodes and cable cleaning/disinfection/sterilisation ...... 127
10.7 Disposal at the End of the Device's Useful Life............. 129
10.8 Inspection and Checklist Tables ..................................... 130

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 DEFIGARD HD-7 User guide

10.8.1 Monthly........................................................................................... 130

10.8.2 Every 12 months ............................................................................ 131
10.8.3 Lifed-item replacement every 5 to 10 years ................................... 131
10.9 Error Detection ................................................................. 132
10.9.1 General errors ................................................................................ 132
10.9.2 Technical information and error messages .................................... 133
10.9.3 Preventing electromagnetic interferences...................................... 134
10.9.4 Measures to prevent electromagnetic interference ........................ 135

11 Technical Data ...................................... 136

11.1 System Data ...................................................................... 136
11.2 Defibrillation Waveform ................................................... 138
11.2.1 Shock Advisory System (SAS)....................................................... 142
11.3 Pacemaker......................................................................... 146
11.4 Technical Data (Monitoring) ............................................ 147
11.4.1 ECG ............................................................................................... 147
11.4.2 Features of pacemaker pulse rejection .......................................... 148
11.4.3 NIBP............................................................................................... 148
11.4.4 SpO2 - Pulsoximetry Masimo......................................................... 149
11.4.5 SpO2 - Pulsoximetry Nellcor .......................................................... 150
11.4.6 EtCO2 - Capnography.................................................................... 151
11.5 WLAN Standard ................................................................ 153
11.6 Device Configuration ....................................................... 153
11.6.1 General configuration..................................................................... 153
11.6.2 Defibrillator ..................................................................................... 154
11.6.3 Digital signal processing ................................................................ 155
11.6.4 AED................................................................................................ 155
11.6.5 CPR................................................................................................ 156
11.6.6 ECG ............................................................................................... 157
11.6.7 NIBP............................................................................................... 157
11.6.8 SpO2............................................................................................... 157
11.6.9 EtCO2 ............................................................................................. 157
11.6.10 Time and date ................................................................................ 158
11.6.11 Event .............................................................................................. 158
11.6.12 Email configuration......................................................................... 158
11.6.13 Email addresses............................................................................. 158
11.6.14 Transmission.................................................................................. 158
11.6.15 Ethernet.......................................................................................... 159
11.6.16 Print................................................................................................ 159
11.6.17 Wi-Fi............................................................................................... 160
11.6.18 SEMA ............................................................................................. 160
11.6.19 SCHILLER Update Server (SUS)................................................... 161
11.6.20 Maintenance................................................................................... 161
11.7 Electromagnetic Interferences ........................................ 161
Art. no: 0-48-0366 Rev: g

11.7.1 Electromagnetic emissions ............................................................ 161

11.7.2 Electromagnetic immunity .............................................................. 162
11.7.3 Immunity to proximity fields from RF wireless communications
equipment ...................................................................................... 164

12 Appendix ............................................... 165

12.1 Accessories and Disposables ......................................... 165
12.2 Accessories DEFIGARD HD-7 ......................................... 165
12.3 Literature ........................................................................... 167
12.4 Glossary ............................................................................ 167

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 DEFIGARD HD-7

13 Index ......................................................169

14 Appendix - Symbols .............................171

Art. no: 0-48-0366 Rev: g

Page 8
 Safety Notes 1
DEFIGARD HD-7 User guide User Profiles 1.1

1 Safety Notes
The DEFIGARD HD-7 is a monitor/defibrillator for hospital use.

All hospital services can use the DEFIGARD HD-7. These functions allow it to be
used in intra-hospital emergency services, resuscitation rooms and operating blocks.

The device is not intended to be used in an Emergency Medical Services (EMS)

environment, that is, in conditions and settings in which users interact with the device,
in and around the scene of an emergency outside of a professional healthcare facility
where a patient can be given medical care, basic or advanced life support as well as
during professional transport to a professional healthcare facility or between
professional healthcare facilities.

1.1 User Profiles

BLS Qualified medical personnel trained for Basic Life Support (BLS), semi-automatic
defibrillation and Cardiopulmonary Resuscitation (CPR) on the DEFIGARD HD-7
may use the Automated External Defibrillator (AED) operating mode of the
DEFIGARD HD-7.

ACLS Qualified medical personnel trained for Advanced Cardiac Life Support (ACLS) and
trained in the use of the DEFIGARD HD-7 may use the manual defibrillator and AED
operating modes of the DEFIGARD HD-7.

Training An initial training of at least 30 minutes is necessary and sufficient to use the device.
Since all user profiles are professional healthcare providers, regular training course
is not mandatory.
Art. no: 0-48-0366 Rev: g

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1 Safety Notes
1.2 Intended Use DEFIGARD HD-7

1.2 Intended Use

DEFIGARD HD-7 is a defibrillator monitor intended to be used by qualified medical
personnel trained for ACLS or BLS, depending on the device's operating mode/
option. Additional information related to the intended purpose of the detailed function
of the device is provided below:

Defibrillator functions:
Monitoring functions:

 Electrocardiography(ECG)
 Oximetry
 Non-invasive blood pressure
 Capnography

The device can be used with the corresponding accessories for adults, children and
neonates.

Defibrillator
DEFIGARD HD-7 is intended to terminate cardiac arrhythmias with synchronised or
non-synchronised high-voltage defibrillation shocks (External and Internal
defibrillation).

In AED mode, DEFIGARD HD-7 provides a prompted treatment protocol and ECG
analysis periods. The Shock Advisory System (SAS) delivers information on whether
a shock needs to be delivered. User interaction is required to deliver the shock.

For more information; refer to Chapter 5 Defibrillation

The shocks can be synchronised with the QRS or non-synchronised in manual mode.

 The DEFIGARD HD-7 defibrillation function treats Ventricular Fibrillation (VF)

and rapid Ventricular Tachycardia (VT).
 The defibrillation function can also be used for synchronised cardioversion of
Atrial Fibrillation (AF) or ventricular arrhythmias.
The device provides advice for the cardiopulmonary reanimation through several
means depending on the device configuration:
 Metronome: the device prompted a regular sound to guide the rescuer to
perform a chest compression at the rate recommended by the international
guidelines.
 Free CPR: This option is used as a guide in the practice of CPR for patients with
suspected cardiac arrest and where CPR can be performed with the heel of the
hand. It provides real-time feedback on the performed CPR compression rate
based on impedance measurement by the defibrillation electrodes and the
recommendations of the international guidelines.
Art. no: 0-48-0366 Rev: g

 ARGUS LifePoint 2 sensor: This option is used as a guide in the practice of CPR
for patients with suspected cardiac arrest and where CPR can be performed with
the heel of the hand. When attached to the patient's chest, the ARGUS LifePoint
2 provides real-time feedback on the performed CPR compression
measurements of depth, rate and recoil for each single compression.

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 Safety Notes 1
DEFIGARD HD-7 User guide Medical Indications 1.3

External Transcutaneous Pacemaker

 The DEFIGARD HD-7 pacemaker function can be an alternative
to endocardial stimulation for treating bradycardia.
For more information; refer to Chapter 6 Pacemaker
Monitoring
 Depending on the configuration, the DEFIGARD HD-7 monitoring function
delivers the most important parameters ECG, SpO2, EtCO2 RR and Non-
Invasive Blood Pressure (NIBP). It allows continuous patient monitoring with
alarming for each parameter if the value is out of limits.
 The device is intended for single-patient use only.
 The device is designed to meet the specific needs of hospital services.
 The device can be used with the corresponding accessories for adults, children
and neonates.
ECG
The DEFIGARD HD-7 is intended to monitor 6-lead ECG waveforms, Heart Rate
(HR) and record the ECG. For more information; refer to section 4.4 ECG and HR
Monitoring
NIBP
 The DEFIGARD HD-7 is intended to perform non-invasive measurements of
arterial pressure. The measurements use an inflatable cuff on the patient’s arm
or leg. For more information; refer to section 4.7 NIBP Monitoring
SpO2
 The DEFIGARD HD-7 is intended for continuous non-invasive monitoring of
arterial haemoglobin and peripheral pulse functional oxygen saturation.
 The DEFIGARD HD-7 can be equipped with Medtronic NellcorTM OxiMaxTM or
Masimo SET SpO2 sensors.
 The DEFIGARD HD-7 with Masimo SET technology indicates the Perfusion
Index (PI). For more information; refer to section 4.6 SpO2 Monitoring (Option)
EtCO2 and Respiration Rate (RR)
 The DEFIGARD HD-7 is intended for continuous non-invasive measurement
and monitoring of the expired and inspired air's carbon dioxide concentration
and RR.
 The DEFIGARD HD-7 is not intended to be used as an apnoea monitor. For
more information; refer to section 4.8 CO2 Sidestream
Target population
The device can be used for:

 Adult and paediatric older than 8 years old or weighing more than 25 kg.
 Paediatric from 1 year old to less than 8 years old or less than 25 kg (except for
ARGUS LifePoint)
 Paediatric younger than 1 year old (except for ARGUS LifePoint).
Art. no: 0-48-0366 Rev: g

1.3 Medical Indications

1.3.1 Manual mode (ACLS user)
Treatment of Cardiac arrest
When a patient experiences a cardiac arrest, it can present a non-shockable or
shockable ECG rhythm. Shockable ECG rhythms like VF and pulseless VT are
treated with manual non-synchronised defibrillation shocks and supplemental therapy
like CPR, oxygen delivery and drugs.

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1 Safety Notes
1.4 Expected Therapeutic Clinical Patients Benefits DEFIGARD HD-7

Non-shockable ECG rhythms are asystole, Pulseless Electrical Activity (PEA) or any
other type of rhythm that does not require an electric shock and is treated by therapies
like CPR and drugs.

Cardiac arrest during surgery

Internal defibrillation is sometimes necessary at the end of a surgery that involves an
extracorporeal circulation process and a thoracotomy. The patient’s heart might then
present a non-viable cardiac arrhythmia that needs to be directly cardioverted with
spoons (internal defibrillation electrodes).

Treatment of other Cardiac arrhythmia

Synchronised electric shocks can be part of treating some arrhythmia like AF/flutter
or VT.

Internal defibrillation is only available in manual defibrillation mode.

1.3.2 AED Mode (ACLS or BLS user)

Treatment of Cardiac arrest
When a patient experiences a cardiac arrest, it can present a non-shockable or
shockable ECG rhythm.

In the standard chain of survival, which concerns non-shockable and shockable ECG
rhythms patients, DEFIGARD HD-7 is designed to guide the user to perform CPR and
possibly deliver an electric shock. Shockable ECG rhythms like VF and pulseless VT
are recognised by a SAS treated by BLS users with non-synchronised defibrillation
shocks and supplemental therapy like CPR.

Non-shockable ECG rhythms are asystole, Pulseless Electrical Activity (PEA) or any
other type of rhythm that does not require an electric shock and is treated by BLS
users with CPR.

1.3.3 Monitoring
ECG (for more information; refer to section 4.4 ECG and HR Monitoring)

NIBP (for more information; refer to section 4.7 NIBP Monitoring)

SpO2 (for more information; refer to section 4.6 SpO2 Monitoring (Option))

EtCO2 and RR (for more information; refer to section 4.8 CO2 Sidestream)

1.4 Expected Therapeutic Clinical Patients Ben-

efits
Art. no: 0-48-0366 Rev: g

1.4.1 Cardiac arrest

Defibrillation
Defibrillation needs to be delivered in case of VF and pulseless VT. Survival of cardiac
arrest is dismal (usually lower than 10%). It is consistent to focus on a shorter-term
outcome for defibrillation, namely removing fibrillation right after an electric shock.

Learned societies do not define the expected success of electric defibrillation.

SCHILLER Medical defines it according to the bibliographic state-of-the-art. It is
aimed to be > 80% at 5 seconds post-shock (150 or 200 joules).

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 Safety Notes 1
DEFIGARD HD-7 User guide Expected Patient Monitoring Clinical Benefits 1.5

SAS
The performance (sensitivity) and safety (specificity) of the SAS are driven by IEC
Standard 60601-2-4 (International Electrotechnical Commission 2018) and learned
societies (AHA) consensus (Kerber et al. 1997).

In summary, sensitivity for shockable rhythms (VF) should be higher than 90%, and
specificity for non-shockable rhythms should be higher than 95%.

CPR
The device provides information for the rescuer to know when to perform CPR. CPR
is monitored so that the rescuer is guided to follow the guidelines (ERC, AHA). The
global performance related to CPR fully depends on the rescuer's skills.

1.4.2 Non-lethal arrhythmia

Electric cardioversion of AF is based on the delivery of an electric shock in synchrony
with the QRS complex of the patient. Learned societies do not define the expected
success of electric defibrillation. SCHILLER Medical defines it according to the
bibliographic state-of-the-art. Cumulative cardioversion success is aimed to be higher
than 80% after several shocks at 150 or 200 joules.

1.4.3 Open-chest surgeries

Internal defibrillation
Defibrillation needs to be delivered in case of VF and pulseless VT.

Learned societies do not define the expected success of electric defibrillation.

SCHILLER Medical defines it according to the bibliographic state-of-the-art.
Therefore, an acceptable criterion for post-shock efficacy for normothermic patients
presenting with cardiopulmonary bypass-induced VF is 80% at first shock.
Alternatively, if several shocks are necessary, an acceptable criterion for post-
procedure efficacy is 100%.

1.4.4 Patients with signs of bradycardia (syncope)

Transcutaneous cardiac Pacing is used in the case of bradycardic patients. Learned
societies do not define expected success, and bibliographic state-of-the-art does not
provide information to define a quantified criterion. Therefore, learned societies only
recommend the pacing in the second intention (after anticholinergic drugs).

1.5 Expected Patient Monitoring Clinical Bene-

fits
Monitoring is applied to almost all patients presenting with some symptoms. It
encompasses a wide variety of pathologies and allows the professional user to detect
Art. no: 0-48-0366 Rev: g

dramatic changes in the patient's status.

Learned societies do not define the expected success of all these monitoring
parameters, and bibliographic state-of-the-art does not provide information to define
a quantified criterion.

Clinical criteria indicating the deterioration of a patient's state of health belong to each
physician's medical knowledge and experience and depend on the patient's
condition and physiological status. Alarm warnings of the monitor DGHD-7 and alarm
sets help the physician depict a trend in the patient's health.

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1 Safety Notes
1.5 Expected Patient Monitoring Clinical Benefits DEFIGARD HD-7

Therefore, the success of these monitoring parameters to benefit patient health and
care management depends on professional knowledge and experience; thus, no
quantifiable data are available.

1.5.1 6-lead ECG monitoring

The benefit for the patient is the recording of the ECG and the HR, allowing a
professional to detect any changes in the patient's condition and establish a diagnostic
to adjust the care management such as drug delivery and switch on an electrical
therapy (refer to the paragraphs above regarding these electrical therapies).

1.5.2 NIBP monitoring

The NIBP monitoring benefit for patients is the determination of the systolic, diastolic
and mean blood pressures, allowing professionals to detect any changes in the
patient's condition and establish a diagnostic to adjust the care management such as
drug delivery and switch on an electrical therapy (refer to the paragraphs above
regarding these electrical therapies).

1.5.3 SpO2 monitoring

The SpO2 monitoring benefit for patients is the measurement of the functional oxygen
saturation of arterial haemoglobin and peripheral pulse, allowing professionals to detect
any changes in the patient's condition and establish a diagnostic to adjust the care
management such as drug delivery and switch on an electrical therapy (refer to the
paragraphs above regarding these electrical therapies).

1.5.4 EtCO2 and RR monitoring

The EtCO2 monitoring benefit for patients is the measurement of carbon dioxide
concentration of expired and inspired air. This monitoring indicates to the professional
the amount of CO2 present at the end of exhalation and the RR. This information
allows the professional to detect changes in the patient's condition and establish a
diagnostic to adjust the care management, such as drug delivery and switch on an
electrical therapy (refer to the paragraphs above regarding these electrical therapies).

Art. no: 0-48-0366 Rev: g

Page 14
 Safety Notes 1
DEFIGARD HD-7 User guide Contraindication For Use 1.6

1.6 Contraindication For Use

Treatment of Cardiac arrest
 The manual or semi-automatic defibrillator of the DEFIGARD HD-7 must
not be used when the person:
– Is responsive
– Is breathing normally
– Has a pulse.
Treatment of other Cardiac arrhythmia
Defibrillation is contra-indicated in the treatment of asystole and Pulseless Electrical
Activity (PEA).

Other contraindications for use

 Do not use the device in or near Magnetic Resonance Imaging (MRI) equipment.
 Danger of explosion: The device must not be used in areas where there is any
danger of explosion. There might be a danger of explosion in areas where
flammable products (petrol), flammable anaesthetic agents or products for skin
cleaning/disinfection are in use or where the ambient air oxygen concentration
is higher than 25%.
 The DEFIGARD HD-7 is not a bedside monitor and must not be used for more
than 24 hours continuously.
CPR feedback using ARGUS LifePoint
 The CPR feedback ARGUS LifePoint sensor is contraindicated for use on
neonatal and paediatric patients under 8 years and < 25 kg.
 CPR feedback option is contraindicated when manual CPR is contraindicated.

1.6.1 Monitoring
ECG (for more information; refer to section 4.4 ECG and HR Monitoring)

NIBP (for more information; refer to section 4.7 NIBP Monitoring)

SpO2 (for more information; refer to section 4.6 SpO2 Monitoring (Option)

EtCO2 and RR (for more information; refer to section 4.8 CO2 Sidestream)

1.7 Known Side Effects

 Defibrillating and pacing a patient can cause:
– Skin irritations or burns. Using pads or, if using paddles, placing gel on the metal
plates decreases contact impedance and decreases the risk of burns.
– Malfunction or damage of implanted pacemaker
 Refer to the detailed safety notes in section 5.1 Application Guidelines and Safety
Art. no: 0-48-0366 Rev: g

Notes
Monitoring
ECG (for more information; refer to section 4.4 ECG and HR Monitoring)

NIBP (for more information; refer to section 4.7 NIBP Monitoring)

SpO2 (for more information; refer to section 4.6 SpO2 Monitoring (Option))

EtCO2 and RR (for more information; refer to section 4.8 CO2 Sidestream)

Page 15
1 Safety Notes
1.8 Responsibility of the User DEFIGARD HD-7

1.7.1 Monitoring
ECG (for more information; refer to section 4.4 ECG and HR Monitoring)

NIBP (for more information; refer to section 4.7 NIBP Monitoring)

SpO2 (for more information; refer to section 4.6 SpO2 Monitoring (Option)

EtCO2 and RR (for more information; refer to section 4.8 CO2 Sidestream)

1.8 Responsibility of the User

 The numerical and graphical results and any interpretation given must be
examined to the overall clinical condition of the patient and the general recorded
data quality.
 The indications given by this device are not a substitute for regular checking of
vital functions.
 Always ensure that the screen/alarm LED of the device can be seen in case the
audible alarms cannot be heard or are turned OFF (refer to section
4.2.2 Operator’s position)
 Do not start or operate the device unless the setup is verified to be correct.
 Operating a device with a defective casing, cables, sensors, paddles, or spoons
constitutes a danger to the patient or the user. Therefore:
– Immediately replace a damaged unit, damaged cables, sensors, paddles,
spoons and connections. Damaged or missing components must be replaced
immediately.
– When an event such as a component drop of approximately 1 meter or greater
or a spillage of blood or other liquids occurs, carry out the safety test before fur-
ther use.
 The device, including the sensor and accessories, must be serviced regularly.
(refer to section 10.1.1 Maintenance interval table)
 The DEFIGARD HD-7 is an emergency device and must be ready for operation
at any time and in all situations. Ensure that the battery is always sufficiently
charged.
 Properly dispose of the packaging material and ensure it is out of children's
reach.

1.9 Organisational Measures

 Before using the unit, ensure an introduction regarding the unit functions and the
safety precautions has been provided and understood.
 Ensure the user has read and understood the user guide, especially these safety
notes.
Art. no: 0-48-0366 Rev: g

 Always store the user guide at hand near the device. Make sure that the
instructions are always complete and legible.

Page 16
 Safety Notes 1
DEFIGARD HD-7 User guide Safety Conscious Operation 1.10

1.10 Safety Conscious Operation

 This user guide must be read and observed, especially these safety notes.
 Danger of electric shock
The energy applied to the patient can be conducted through the patient to other
persons who may suffer a lethal electric shock. Therefore:
– Do not touch the patient, the electrodes or other conducting objects during de-
fibrillation
– Do not defibrillate the patient in a puddle of water or on other conductive
surfaces
– Switch the device OFF when it is no longer used.
 This device must only be connected to a mains supply with protective earth to
avoid the risk of electric shock.
 For patient safety, it must be ensured that neither the electrodes, including the
neutral electrode, nor the patient, or persons touching the patient, come into
contact with conducting objects, even if these are earthed.
 Immediately report any changes that impair safety (including operating
behaviour) to the person responsible.
 Only connect original SCHILLER accessories to the device.
 Before switching on, check if the unit's casing and electrode connection are
undamaged.
 Only operate the device in accordance with the specified technical data.
 Do not expose the device to great temperature variations over a long period.
Major temperature variations can cause condensation of water on the unit.
Should condensing water nevertheless occur, dry the unit, the defibrillation
electrodes and all connections.
 Special caution must always be taken on intracardiac application of medical
equipment. Especially make sure that no conducting parts connected to the
unit's isolated patient input (patient, plug, electrodes, sensor) come into contact
with other, earthed conductive objects, as this might short-out the patient's
isolation and remove the protection of the isolated input.
 Carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
 The user shall always remain close to the patient during monitoring.
 Do not place the device where the patient can control the device.
 Position the device so that it is not possible to fall on the patient or floor.

 Do not reuse disposable accessories marked with the symbol to prevent

cross-infection.
 If unexpected readings are obtained, the operator should check the connections
and verify the readings according to section 10.2.5 Functional test - measured
value.
Art. no: 0-48-0366 Rev: g

Page 17
1 Safety Notes
1.11 Operation with other Devices DEFIGARD HD-7

1.11 Operation with other Devices

 Use only accessories and other parts recommended or supplied by SCHILLER.
Using other than the recommended or supplied parts may result in injury,
inaccurate information or damage to the unit.
 The patient can be endangered by too high leakage currents (summation of
leakage currents):
– Several devices are connected to the patient
– Other equipment is connected to the DEFIGARD HD-7
For this reason, devices that are not required should be disconnected from the
patient, and only equipment approved by SCHILLER may be connected to the
device.
 Accessory equipment connected to the analogue and digital interfaces must be
certified according to the respective IEC standards (for example, IEC/EN 60950
for data processing equipment and IEC/EN 60601-1 for medical equipment). In
addition, all configurations shall comply with the valid version of the system
standard IEC/EN 60601-1. Everyone who connects additional equipment to the
signal input or output configures a medical system and is therefore responsible
that the system complies with the requirements of the valid version of the system
standard IEC/EN 60601-1. If in doubt, consult the technical service department
or your local representative.
 Magnetic and electrical fields of X-ray equipment, tomographs, portable

communication devices, HF radios and devices labelled with the symbol

can affect the operation of this device (refer to section 10.9.3 Preventing
electromagnetic interferences.) Avoid using such devices or keep a sufficient
distance from them.
 Magnets used to configure internal pacemakers may disturb the good
functioning of the device, especially its defibrillation module. Therefore, do not
place any magnet of any kind inside the bag of the unit.
 The charging of energy and the release of the defibrillation impulse can disturb
other devices. Check these devices before their further use.
 Sensors and devices not defibrillation-proof must be disconnected from the
patient before a shock is triggered.
 If the patient has a pacemaker implant, do not position the electrode directly onto
the pacemaker. AHA and ERC's last guidelines for ALS recommend that when
treating an adult with a permanent pacemaker or an ICD, the defibrillator
external paddles/pads should be placed on the chest wall, ideally at least 8 cm
from the generator position. In addition, the anterior-lateral and anterior-
posterior paddle/pad placements on the chest are acceptable in patients with a
permanent pacemaker or ICD. After restoration of the spontaneous circulation,
pacemakers should always be checked for possible damage.
 The DEFIGARD HD-7 can be used together with high-frequency electrosurgical
devices. However, precautions must be observed when such HF equipment is
used. To reduce the risk of burns in the case of neutral HF electrode failure, a
distance of at least 15 cm must always be kept between the defibrillation and HF
Art. no: 0-48-0366 Rev: g

surgical electrodes. If in doubt, disconnect the electrodes and sensors from the
unit using an HF surgical device. In addition, it may affect the accuracy or
availability of the oximeter measurements.

Page 18
 Safety Notes 1
DEFIGARD HD-7 User guide Maintenance 1.12

1.12 Maintenance
 Danger of electric shock. Do not open the device; there are no serviceable parts
inside. Refer servicing to qualified personnel only.
 No modification of this equipment, including sensors and accessories, is
allowed.
 Before cleaning, switch the unit OFF and remove the battery.
 Do not use high-temperature sterilisation processes
(such as autoclaving). Do not use E-beam or gamma radiation sterilisation.
 Do not use solvent or abrasive cleaners on the unit or cable assemblies.
 Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

1.13 Hygiene
 For cleaning and disinfection, observe the legal requirements applicable.
 Only use cleaning agents and disinfectants recommended by SCHILLER.
Unsuitable agents can damage the device. Clean and disinfect the device per
the instructions in this book.

1.14 Cybersecurity
1.14.1 Networks and the internet

 The security of the network is the sole responsibility of the user.

 When the unit is part of a network (LAN, WLAN, HIS) or any other transmission/
reception medium, or if exposed to the Internet or other insecure networks,
appropriate security measures must be taken to protect the stored patient data.
 To guarantee the cybersecurity of the network, SCHILLER recommends the
following:
– Isolating the DEFIGARD HD-7 network from other networks
– Defining access authorisation for the host system's configuration, including DE-
FIGARD HD-7, so that no unauthorised system alterations are possible.
– Use an SMTP server with authentication with TLS support
– Use Transport Layer Security (TLS) 1.2 or higher to communicate with the sys-
tem and SEMA servers.
– Use a WLAN network with WPA2 configuration.

Internet Protocol: Only IPv4 is supported; IPv6 has not been validated.
Art. no: 0-48-0366 Rev: g

Page 19
1 Safety Notes
1.15 Additional Terms DEFIGARD HD-7

1.14.2 Patient data (personal data)

 Patient data security is the sole responsibility of the user. Therefore:

– Delete personal data (intervention file) before sending the device for repair or
maintenance.
– If a device has been sent to SCHILLER with personal data, the data is deleted
before starting the repair or maintenance process.
Exception investigation in case of incident reporting
 If a device is sent for investigation in case of incident reporting, the intervention
data are very important to detect the cause. Therefore:
– The device can be sent to SCHILLER by the responsible organisation with per-
sonal
data.
– The intervention file with the personal data can be exported if possible (refer to
section 8.1 Intervention data) and sent to SCHILLER by the responsible organ-
isation.
– After the investigation, SCHILLER confirms all personal data has been deleted
from services, applications and the device. The device is returned to the cus-
tomer without any personal data.

1.15 Additional Terms

1.15.1 Implied authorisation
Possession or purchase of this device does not convey any express or implied license
to use the device with unauthorised sensors or cables which would, alone or in
combination with this device, fall within the scope of one or more of the patents
relating to this device.

1.15.2 Terms of warranty

Your SCHILLER DEFIGARD HD-7 is warranted against defects in material and
manufacture according to the general terms and conditions. This guarantee excludes
damage caused by an accident or as a result of improper handling. The warranty
entitles free replacement of the defective part. Any liability for subsequent damage is
excluded. The warranty is void if unauthorised or unqualified persons attempt to make
repairs.

Send the device to your dealer or the manufacturer in case of a defect. The
manufacturer can only be held responsible for the safety, reliability, and performance
of the device if:

• Assembly operations, extensions, readjustments, modifications, or repairs are

carried out by persons authorised.
• The DEFIGARD HD-7 and any approved attached equipment are used per the
Art. no: 0-48-0366 Rev: g

manufacturer's instructions.

No express or implied warranties extend beyond the warranties herein above set forth.
SCHILLER does not warranty merchantability or fitness for a particular purpose
concerning the product or parts thereof.

Support period
Software updates are available 10 years from when the last device was placed on the
market (Cybersecurity guidelines).

Page 20
 Safety Notes 1
DEFIGARD HD-7 User guide Display Symbols and Indicators 1.16

1.15.3 Reporting serious incident disclosure policy

If any serious incident has occurred to the device, it should be reported to the
manufacturer (customercomplaint@schiller.fr) and the competent authority of the
Member State in which the user or patient is established.
SCHILLER will acknowledge your message within 3 days and validate the incidence
within 10 days. Allow 90 days before disclosing this incidence publicly.

1.15.4 Reporting security incidents and vulnerability disclosure policy

If a vulnerability is found in one of our products or services, send the details to
customercomplaint@ schiller.fr.
SCHILLER will acknowledge your message within 3 days and validate the
vulnerability within 10 days. Allow 90 days before disclosing this vulnerability publicly.

1.15.5 Additional information

Changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction, may cause harmful
interference to radio communications. However, there is no guarantee that
interference does not occur in a particular installation. If the device causes harmful
interference to radio or television reception, which can be determined by turning the
equipment OFF and ON. In that case, the user is encouraged to try to correct
interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and the receiver.
• Connect the equipment to a circuit different from that the receiver is connected to.
• Consult the dealer or an experienced radio/TV technician for help.

1.16 Display Symbols and Indicators

1.16.1 Symbols used in this user guide
The safety levels are classified according to ISO 3864-2. The following overview
Art. no: 0-48-0366 Rev: g

shows the safety symbols and pictograms used in this user guide. Danger, Warning,
and Caution are used in this user guide to point out potential dangers and indicate
risk levels. Familiarise yourself with their definitions and significance.

This symbol warns of possible direct danger, which could lead to severe personal
injury or death.

Page 21
1 Safety Notes
1.16 Display Symbols and Indicators DEFIGARD HD-7

This symbol warns of a possible dangerous situation that could lead to severe
personal injury or death.

This symbol warns of a dangerous situation that could lead to personal injury and/or
indicate possible property damage.

For general safety notes as listed in this section.

For electrical hazards, warnings or precautionary measures when dealing with

electricity.

This symbol warns of dangerous situations that could damage property or system
failure and provides other important user information.

Reference to other guidelines

Touch-sensitive areas
This symbol is used to designate touch-sensitive areas that might not be self-evident.

Touch (to open/close menus and perform functions)

Move up or down.

Move to the right or left.

1.16.2 Symbols used on the device

For generally used symbols; refer to Chapter 14 Appendix - Symbols.
Art. no: 0-48-0366 Rev: g

Reading the instructions for use is mandatory before using the device.

Caution: Consult the warning and safety information in the instructions for use.

Signal input type CF: Highly isolated port, defibrillation protected. However, it is only
defibrillation-protected when used with the original SCHILLER patient cable.

Page 22
 Safety Notes 1
DEFIGARD HD-7 User guide Display Symbols and Indicators 1.16

BF symbol. The device's signal input is defibrillation-protected.

Dangerous voltage. Used for electrical dangers during defibrillation

(DEFIGARD HD-7)

The device is protected against foreign bodies with a diameter greater than 2.5 mm
IP33
and against spraying water.

CO2 gas sample exhaust port to the scavenging system of the hospital

CO2 gas sample inlet port for the Nomoline sampling line

Potential equalisation. To prevent leakage current, the device must be connected to

the room's central potential equalisation via the potential equalisation socket.

Fuse

45°C
Battery: Normal storage temperature duration and allowed out-of-range
0°C temperature duration

Devices with WLAN

Attention: Non-ionising electromagnetic radiation environment, the device contains
an HF transmitter.

Non-ionising electromagnetic radiation The DEFIGARD HD-7 radiates high-frequency electromagnetic energy during
telemetric data transfer and can disturb other devices if not installed and operated in
accordance with the user guide.

However, even in the case of correct installation/operation, there is no guarantee that

no interferences can occur.

If the DEFIGARD HD-7 causes interferences, these can be prevented by switching

OFF or not sending data.

The user can take the following measures to solve this problem:
Art. no: 0-48-0366 Rev: g

• Increase the distance between the disturbed device and the DEFIGARD HD-7.
A minimum distance of 20 cm must be kept between the device and a pacemaker.
• Turn the device to change the antenna's angle of radiation.
• Connect the device to a different mains connector.
For more information (refer to section 10.9.3 Preventing electromagnetic interferenc-
es)

Page 23
1 Safety Notes
1.16 Display Symbols and Indicators DEFIGARD HD-7

1.16.3 Symbols used on the electrode package

For generally used symbols; refer to Chapter 14 Appendix - Symbols.

1. Open the clothes

2. Open the electrode package
3. Peel off the protective foil
Adults
4. Place and attach the electrodes.

Children

Reading the instructions for use is mandatory before using the device.

Disposable item; single use only.

Do not bend the packaging.

Do not use if the packaging is damaged.

Storage temperature for the electrodes.

Expiration date

Use within 1 day after opening

Defibrillation electrodes for adults and children with body weight higher than 25 kg

Defibrillation electrodes for children with body weight lower than 25 kg

Art. no: 0-48-0366 Rev: g

Page 24
 Components and Operation 2
DEFIGARD HD-7 User guide Design 2.1

2 Components and Opera-

tion
The DEFIGARD HD-7 is a mains and battery-powered defibrillator featuring an ECG
monitor, SpO2 EtCO2, and NIBP measurements. It is designed for clinical use.
Defibrillation is possible in non-synchronised or synchronised mode.

The device can be switched to Monitoring, Pacemaker, Manual and AED defibrillation
using a rotary switch.

Biocompatibility
The parts of the product described in this user guide and all accessories that come in
contact with the patient during the intended use fulfil the biocompatibility requirements
of the applicable standards. If you have questions in this matter, contact SCHILLER.

2.1 Design
Power supply The DEFIGARD HD-7 is powered by mains or the integrated rechargeable battery.

Defibrillator The DEFIGARD HD-7 is a defibrillator featuring biphasic pulsed defibrillation impulse
Multipulse Biowave. The defibrillation is done using disposable adhesive electrodes
(pads), reusable paddles or spoons (for internal defibrillation)

The device automatically recognises the type of connected electrodes (pads,

paddles, or spoons). Adult or children's paddles and pads are also automatically
recognised, and the device's behaviour is adapted accordingly (Energy level, CPR
ratio, user interface).

Manual defibrillation The user can select the energy to be delivered and enable/disable the
synchronisation for cardioversion therapy.

AED defibrillation The user is provided with visual and audible instructions. The user cannot select the
energy. If paddles are connected, the user is prompted to connect pads.

Pacemaker According to its configuration, the DEFIGARD HD-7 features an external pacemaker
function that can be operated in either demand or fixed mode.

Monitoring According to its configuration, the DEFIGARD HD-7 can provide the following
monitoring functions:

• ECG and HR
Art. no: 0-48-0366 Rev: g

• SpO2, Peripheral Pulse (PP), plethysmogram

• EtCO2 and RR
• NIBP

Display The DEFIGARD HD-7 is equipped with a large 7ʺ colour LCD and operated by a touch
panel.

Data storage All intervention data, lead II ECG, defibrillator ECG, SpO2 curves, trends, events, and
patient data.

Page 25
2 Components and Operation
2.1 Design DEFIGARD HD-7

Data transmission The DEFIGARD HD-7 is capable of exporting and sending information over
different communication media, including:

• WLAN
• Ethernet (over USB adapter)
• To a USB stick

The details of communication capabilities are detailed in the table below:

USB WLAN Ethernet

Intervention data to Intervention data to

Intervention report in
SCHILLER SCHILLER
PDF
Server Server
Configuration update Configuration update
Import/export
through SCHILLER through SCHILLER
configuration
Server Server
Software update through Software update through
Software update SCHILLER SCHILLER
Server Server

Thermal Printer The DEFIGARD HD-7 is equipped with a thermal printer that can be used for
intervention documentation or technical documentation.

2.1.1 Standard unit and options

Standard
• Manual defibrillator
• AED
• 6-lead ECG with a 4-wire ECG cable
• WLAN
• Printer
Options:
• External pacemaker
• SpO2 Masimo Set or SpO2 Nellcor
• NIBP
• EtCO2
• CPR feedback

The DEFIGARD HD-7 exists in several versions that fit the user's needs. For more
precise information, contact your local sales representative.
Art. no: 0-48-0366 Rev: g

Page 26
 Components and Operation 2
DEFIGARD HD-7 User guide Operating Elements 2.2

2.2 Operating Elements

2.2.1 Front panel DEFIGARD HD-7

Paddles
Main supply and battery
charging Status LED
Status or alarm LED

Rotary selection
Touch screen key for ON/OFF
and operating
mode selection

Charge key

Shock key

Defi pads,
Paddles or
Spoon
connector

Printer Loudspeaker

USB CPR
Feedback
Art. no: 0-48-0366 Rev: g

SpO2
NIBP
ECG patient cable

EtCO2 sampling line

Fig. 2.1 Control elements at the device’s front

Page 27
2 Components and Operation
2.2 Operating Elements DEFIGARD HD-7

2.2.2 Back panel

Exhaust ISA
sidestream module

Rail fixing hook

Potential equalisation
connector

2 x Fuse 2.5 AT 250V

Power battery compartment Mains supply connector

Fig. 2.2 Control elements at the device back

2.2.3 LEDs
The LEDs give the following information:

(5) Flashes while the battery is recharging

1 2 (6) Lit when the device is connected to the mains supply.

Fig. 2.3 LEDs

Art. no: 0-48-0366 Rev: g

Page 28
 Components and Operation 2
DEFIGARD HD-7 User guide Operating Elements 2.2

2.2.4 Display
Filter mode: Monitoring, Rhythm Network and transmission status Patient information
Intervention duration
Display field for system and alarm mes-
sages. Touch to show the alarm list. Battery charging status
Date/time
Alarm status

Black and white

display SpO2: Startup state
Off
Adult

HR
Heart rate
ECG calibration
impulse 1 mV
SpO2 and
temperature

EtCO2 and
respiratory rate
NIBP
Waveform field
NIBP

NIBP History

NIBP History

Soft keys ECG Event Screenshot Print Start Menu

Start/stop NIBP measurement

Fig. 2.4 Display elements of the device

The display can vary according to the settings, options and selected views. The fol-
lowing screen is displayed when swiping from right to left; see above.

SpO2: Startup state

Adult Off

HR

Show the ECG curve again:

 Swipe from left to right NIBP NIBP History

Art. no: 0-48-0366 Rev: g

ECG Event Screenshot Print Start Menu

Page 29
3 Initial Operation
3.1 Mains Supply and Battery Operation DEFIGARD HD-7

3 Initial Operation
 Read the safety notes in Chapter 1 Safety Notes, before initial operation.
 Danger of explosion. The device is not designed for use in areas where an
explosion hazard may occur. Operating the defibrillator in an oxygen-enriched
environment or in the presence of flammable substances (gas) or anaesthetics
is not permitted. Oxygenation in the vicinity of the defibrillation electrodes must
be strictly avoided.
 Danger of electrical shock. The DEFIGARD HD-7 is a high-voltage therapy
device. Improper use of the device can endanger life. Always follow the
instructions given in this user guide.
 During ECG analysis and defibrillation, the user must check that there are no
conductive connections between the patient and other persons.
 Avoid defibrillation in very moist or wet surroundings.
 This device must only be connected to a mains supply with protective earth to
avoid the risk of electric shock.

3.1 Mains Supply and Battery Operation

Important
The battery is set to deep sleep mode to prevent the unit from switching ON (self-test)
during transport. To wake up the battery, connect the device to the mains supply as
described in the following section:

3.1.1 Mains supply and charging battery

1. Connect the device to the mains supply.
2. Check that LED 2 is ON.
3. If necessary, connect the potential equalisation cable to the central potential
equalisation socket.
4. Switch the device ON by selecting Monitor mode.
1 2 Mains supply

On

3
5. The battery symbol shows that the mains supply is connected.
Art. no: 0-48-0366 Rev: g

6. Touch the battery icon (3) to display further battery charging information.
7. Check that battery charging LED 1 according to 3.1.2 Battery Operation.
8. Check that the battery is fully charged after initial operation.

Battery supply

On

Fig. 3.1 Status LED supply

Page 30
 Initial Operation 3
DEFIGARD HD-7 User guide Mains Supply and Battery Operation 3.1

3.1.2 Battery Operation

The device must be connected to the room's central potential equalisation via the po-
tential equalisation socket to prevent leakage current.

A potential equalisation cable (article no. U50030) can be obtained from SCHILLER.

Position the device so the mains cable can easily be unplugged from both sides of the
device and mains socket. The internal battery is automatically recharged when
connected to the mains. The battery requires approximately 2 hours to be 90%
recharged.

Automatic shut down

The device automatically shuts down after 30 minutes if no activity has been detected
(no vital signs measurement or no action from the user) to prevent the device from
emptying its battery.

3.1.3 Charging the battery

Important
The power battery is automatically recharged when connected to the main supply, see
LED 2. The battery requires approximately 2 hours to be recharged at 90%.
1 2
The LED above the battery symbol indicates the recharging of the battery.

– LED (1) continuously ON = battery problem

– LED (1) blinking = the battery is charging
– LED (1) continuously OFF = battery is fully charged.

Fig. 3.2 LED battery operation

If the temperature in the device becomes too high, the charging is stopped. Charging
resumes as soon as the temperature has decreased to an acceptable level.

Low battery indication

below 20%
When the battery is below 20%, a red battery symbol with one bar is displayed in the
top right corner of the screen.
below 10%
When the battery is below 10%, a red empty battery symbol is displayed in the top
right corner of the screen, a technical alarm is displayed, and a voice prompt reminds
you to connect the device to the mains supply.

The device shuts down automatically when the battery is below 5%.
Art. no: 0-48-0366 Rev: g

Fig. 3.3 Battery low indication

Battery status unknown

• When the battery is unknown, a red battery symbol with a question mark is
displayed in the top right corner of the screen.
• This indicator is also displayed in case of a new battery. Any new battery has to be
placed into the device and fully charged before use.
Fig. 3.4 Battery defect indication

Page 31
3 Initial Operation
3.2 Switching Off, disconnecting from the Mains Supply DEFIGARD HD-7

Battery replacing indication

• When the battery does not charge enough, the red with the white battery symbol is
displayed. Replace the battery by an authorised person.

Fig. 3.5 Replace battery indication

Battery status
Press the battery icon. The following information is displayed:

• Charge level as a percentage (%)

• Estimated autonomy in hours and minutes
• Estimated number of shocks possible with the remaining capacity.

3.2 Switching Off, disconnecting from the Mains

Supply
1. Switch the device OFF by selecting the Off position.
2. Remove the mains cable from the device if you do not want to recharge the bat-
tery.

3.2.1 Internal safety discharge

The DEFIGARD HD-7 has an internal safety discharge circuit to discharge the
defibrillator’s stored energy. The defibrillator displays the message Internal discharge
during the safety discharge. The energy is internally discharged when:

• The shock is not delivered within 20 seconds after charging

• A lower energy value is selected while the defibrillator is charging
• A shock is delivered into the open air
• The battery voltage is insufficient
• The device is defective
Art. no: 0-48-0366 Rev: g

• The device is turned OFF

In addition, the residual energy stored in the defibrillator 100 ms after shock release
is always discharged internally.

3.2.2 Interruption of the mains supply

The device automatically switches to battery operation if the mains supply is

interrupted. All user settings are maintained.

Page 32
 Initial Operation 3
DEFIGARD HD-7 User guide Switching Off, disconnecting from the Mains Supply 3.2

3.2.3 Ensuring operational readiness

Do not expose the device to direct sunlight or extremely high or low temperatures. The
ambient temperature should be in the range of 0 to 50°C. Lower or higher ambient
temperatures have a negative impact on the battery's life.

The device runs a self-test to check the unit and the battery to ensure its readiness for
use. A self-test can be performed at any time. An enhanced periodic test can be
performed in a defined interval (standard setting every 5 weeks) and at a defined time
(standard setting 12:00).

• Status OK: green blinking LED

• Device failure status: LED OFF
An alarm sound is activated if the device detects an error during the self-test.

 A self-test can be executed anytime; refer to section 10.2.4 Self-test.

Low battery capacity indication while the device is switched off

• Low battery capacity indication is the same during the self-test and the manual self-
test.
• If the battery capacity falls below 10%, the status LED is off, and an acoustical no-
tification is issued. These indications are issued until the device is connected to the
mains supply, and the battery is sufficiently recharged.
• Despite the low battery indication, the device can still be used normally and perform
about 25 defibrillation shocks.
• The remaining battery capacity depends on the use and ambient conditions.
 Immediately connect the device to the mains supply to recharge the battery.
Art. no: 0-48-0366 Rev: g

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3 Initial Operation
3.3 Operation DEFIGARD HD-7

3.3 Operation
The menus can be accessed as follows:

• Direct access by pressing on the curve or measurement field

• By clicking on the menu softkey or any other softkey
• By clicking on an icon
• Move the finger up or down, left or right, for scrolling or changing the display.

---
Adult Off

HR

NIBP

NI
NIBP History

ECG Event Screenshot Print Start Menu

Adult Off

HR SpO2

View 6 lead
Leads view
NIBP
Long ECG

Screenshots NIBP History

Art. no: 0-48-0366 Rev: g

Menu
Trends
Stop intervention
ECG Event Screenshot Print Start Menu
Language

Fig. 3.6 Display with main menu and the touch-sensitive areas

Page 34
 Initial Operation 3
DEFIGARD HD-7 User guide Patient Data 3.4

3.4 Patient Data

1. Press to enter into the Patient data menu.

2. Select the field you wish to enter.

There are 3 ways to complete the patient information:

– Enter fields
– Use the PDQ function (For more details, refer to Chapter 8.3.1)
– Use the workflow function(For more details, refer to Chapter 8.3.2)

3.4.1 Patient Data Query (PDQ) (Optional)

1. Press to enter into the Patient data menu.

Art. no: 0-48-0366 Rev: g

2. Select Patient ID

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3 Initial Operation
3.4 Patient Data DEFIGARD HD-7

Patient ID 1

3. Enter the Patient ID (1) and press the PDQ button (2).

If the system cannot find a correspondence/match in the server, the following

message is displayed (3).

Unable to get patient data 3

Art. no: 0-48-0366 Rev: g

Page 36
 Initial Operation 3
DEFIGARD HD-7 User guide Patient Data 3.4

3.4.2 Worklist (optional)

1. Press to enter into the Patient data menu.

2. Select Worklist

3. Synchronising (1)
Art. no: 0-48-0366 Rev: g

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3 Initial Operation
3.5 Printing DEFIGARD HD-7

4. Select a record from the list displayed.

3.5 Printing
The following data can be printed:

• The current monitoring data (including patient data, patient vitals, ECG, SpO2,
EtCO2 curves)
• The following data from the memory (select via the menu button):
– Long ECG records
– Screenshots that contain all displayed curves, patient data and vital data
– Trends
– Events
– Self-test result
– Defibrillation report
– Device configuration

• Depending on the device’s configuration, an automatic printout can be triggered:

– On shock delivery
– On VF/VT or asystole detection
– When an alarm limit threshold is exceeded
– On manual event
– On self-test

The DEFIGARD HD-7 can be configured to print curves with an anteriority of 8

seconds. Only the 3 first curves are printed.
Art. no: 0-48-0366 Rev: g

• In Monitor mode, the behaviour of the Print button can be configured to print:
– 10 seconds of curves
– 20 seconds of curves
– 30 seconds of curves
– Indefinitely, until interruption by the user

Always cut the paper to face the top of the device to reduce the risk of paper jams.

Page 38
 Initial Operation 3
DEFIGARD HD-7 User guide Printing 3.5

3.5.1 Changing printing paper

Important
The device is delivered without printing paper inserted. The thermal paper is sensitive
to heat, humidity and chemical vapours. The following points apply to both paper
storage and archiving of recordings:

• Before use, keep the paper in its original cover. Do not remove the cover until the
paper is to be used.
• Store the paper in a cool, dark and dry location.
• Do not store near chemicals, for example, sterilisation liquids.
• Do not store in a plastic cover.
• Certain glues can react with the paper. Therefore, do not use any glue on the
printout.

SCHILLER can only guarantee perfect printouts when original SCHILLER chart paper
or chart paper of the same quality is used.
1. Pull down the paper tray.

2. Remove the remaining paper.

3. Remove the plastic spindle and insert it into the new paper roll; see above.

Important: The spindle must be reused when replacing the paper roll
4. Place a new paper roll into the paper tray with the printed (grid) facing upwards.
5. Pull out the paper.

6. Push the paper tray home until it locks into place.

Art. no: 0-48-0366 Rev: g

Page 39
3 Initial Operation
3.6 Trolley DEFIGARD HD-7

3.6 Trolley
When using the DEFIGARD HD-7 on the 2-19-0014 trolley, check that the device is
correctly secured to the bracket.

1. Mount the interface plate onto the device (2 screws at the back of the device)

2. Check that the device is correctly secured to the trolley with the bottom screw.

Art. no: 0-48-0366 Rev: g

Page 40
 Monitoring 4
DEFIGARD HD-7 User guide Soft keys, Waveforms and Measurement Fields 4.1

4 Monitoring
Depending on the configuration, the monitoring function of the DEFIGARDHD-7
delivers the most important parameters ECG, SpO2, EtCO2 RR and NIBP. It allows
continuous patient monitoring with alarms for each parameter if a value is out of limits.

• The device is intended for single-patient use only

• The device is designed to meet the specific needs of hospital services
• The device can be used with the corresponding accessories for adults, children
and neonates.

Operation and menu access is detailed in section 3.3 Operation.

Switch the device ON by selecting, Monitor mode.

4.1 Soft keys, Waveforms and Measurement

Fields
The waveform and measurement fields are automatically displayed when the device
is switched ON (if options are installed). The device can be operated via the touch
screen. The functions of the soft keys vary according to the selected screen.

Adult Off

HR

NIBP
Art. no: 0-48-0366 Rev: g

NIBP History

ECG Event Screenshot Print Start Menu

Fig. 4.1 Advanced monitoring view

Page 41
4 Monitoring
4.1 Soft keys, Waveforms and Measurement Fields DEFIGARD HD-7

Settings
The settings that are defined in the menus are set to default when the unit is switched
OFF.

4.1.1 View selection

The default view after start-up can be configured.

Menu  Go to the menu and select View 6-lead.

View 6-lead
Long ECG

Screenshots

Trend

Review events

Stop Intervention
00547_160318_103611
Language

The display can vary according to the settings and used options. The default views
are displayed as described below.

Adult Off

HR

NIBP

NIBP History

ECG Event Screenshot Print Start Menu

Art. no: 0-48-0366 Rev: g

Fig. 4.2 6-lead ECG with all 6 ECG leads

The displayed ECG is online and filtered with diagnostic filters to make the curves
sensitive to motion artefacts.

Page 42
 Monitoring 4
DEFIGARD HD-7 User guide Alarm System 4.2

4.2 Alarm System

 In some countries, it is not permitted to disable audio alarms

Off
permanently. Therefore, this function is configurable.
 When pausing or switching OFF the audio alarm, high-priority alarms such as
VT/VF and asystole are paused/switched OFF.
 Pausing or switching off the audio alarm system is only allowed if the patient is
permanently observed.

4.2.1 Alarm priority

Priority Audible signal Display Alarm type/Conditions
• Text display in the alarm status field at the top Technical alarm
• Displaying -?- in the parameter field • Sensor off patient
Low • Communication with the
• The Yellow LED is lit.
Triggered module is not possible
One beep once
immediately on
detection • Interference or technical
problems identified by the
monitoring module.
• Text display in the alarm status field at the top
Medium • Red flashing parameter field
Physiological alarm
Triggered 3 3 signals (beep, • The Yellow LED is flashing.
• Monitoring values out of
seconds after beep, beep)
currently defined limits.
detection

• Text display in the alarm status field at the top

10 signals
High • Red flashing parameter field Critical Physiological alarm
(beep, beep, beep,
Triggered 3 • VF/VT detected
beep, beep, beep,
seconds after
beep, beep, beep, • Asystole detected.
detection
beep) • The Red LED is flashing.

4.2.2 Operator’s position

 Check that the environmental noise is below the alarm sound volume of 62 dB.

The visual alarm LED is visible at a distance of 4 meters, and the flashing value is
visible at a distance of 1 meter with an angle of 30°.
Art. no: 0-48-0366 Rev: g

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4 Monitoring
4.2 Alarm System DEFIGARD HD-7

4.2.3 Alarm list

An alarm list can be displayed anytime by touching the alarm status line.

Alarm List
08h02m43s: HR out-of-range (P-ECG03)

08h02m43s:SpO2: Sensor Off Patient (T-SP229)

HR out-of-range
On

4.2.4 Pausing, switching off or reactivating audio alarms Pause

Alarm Settings Default

Pausing an audio alarm Pause
Quick Set: Wide
 Pause the audio alarm by pressing the button (1) and selecting Audio Pause
Quick Set: Narrow – The measurement reading is flashing red until it returns to the permissible range.
– The audible alarm is reactivated automatically if the measured value does not
Audio Pause return to the permissible range within 2 minutes.

Audio OFF
Switching OFF audio alarm system
Off
Reset Alarm/Audio On
 Press the button (1) and select Audio OFF.
 The audible alarm system is switched OFF permanently until it is reactivated by
selecting Reset Alarm/Audio ON or Audio Pause.
A reminder signal (buub-buub) is issued every 2 minutes.
1
Off Pause
Reactivation of the paused or switched OFF audio alarm system
 Press the button (1) and select Reset Alarm/Audio ON.
On

Fig. 4.3 Alarm indicators

Art. no: 0-48-0366 Rev: g

Page 44
 Monitoring 4
DEFIGARD HD-7 User guide Operator Defined Alarm Thresholds 4.3

4.3 Operator Defined Alarm Thresholds

 Check that the patient's vital parameters are not critical before pressing the
Wide or Narrow Quick sets; otherwise, extreme values may render the alarm
system unusable.
 Check that the right patient (adult, child or neonate) is selected.
 The defined alarm thresholds are not a substitute for regularly checking of vital
functions.
 Setting the Audio OFF is only allowed if the patient is permanently observed.
 Standard or user-defined alarm limits and quick settings may vary for similar or
the same devices. Therefore, always check the set alarm limits for the current
patient.
 Thirty seconds after switching OFF the device, the alarm threshold Wide or
Narrow Quick set is set to default.

 Access the threshold menu by pressing the alarm icon and selecting Wide or
Narrow quick set (1).

• With the Quick Set selection, all values are derived from the current measured
1 2 values (refer to table 4.3.1 Table of default threshold setting).
Important
• Check that the patient's vital parameters are not critical before pressing the Quick
Set button.
Alarm Settings Default

Wide Quick Set  With the Default key, the default threshold values are activated (refer to table
4.3.1 Table of default threshold setting).
Narrow Quick Set

Audio Pause

Audio OFF

Reset Alarm/Audio On

Fig. 4.4 Alarm Setting menu

The operator-defined Quick set thresholds are set to default after switching off the
device.
Art. no: 0-48-0366 Rev: g

Page 45
4 Monitoring
4.3 Operator Defined Alarm Thresholds DEFIGARD HD-7

4.3.1 Table of default threshold setting

The default limit values are set after switching on or when the default is selected in
the Alarm settings menu (Fig. 4.4 Alarm Setting menu). The default alarm limits are
predefined for each patient type as specified in the following table.

Parameter Default limit Adult Child Neonate

Upper 120 150 170
HR [bpm]
Lower 50 80 100
Upper 100 100 100
SpO2 [%]
Lower 92 92 90
Upper 160 120 90
NIBP SYS [mmHg]
Lower 90 70 40
Upper 90 70 60
NIBP DIA [mmHg]
Lower 50 40 20
Upper 21.33 16 12
NIBP SYS [kPa]
Lower 12 9.33 5.33
Upper 12 9.33 8
NIBP DIA [kPa]
Lower 6.66 5.33 2.7
Upper 30 30 40
RR [rpm]
Lower 8 10 12
Upper 5.9 5.9 5.9
EtCO2 [%]
Lower 4.0 4.0 4.0
Upper 45 45 45
EtCO2 [mmHg]
Lower 30 30 30
Upper 6 6 6
EtCO2 [kPa]
Lower 4 4 4

Art. no: 0-48-0366 Rev: g

Page 46
 Monitoring 4
DEFIGARD HD-7 User guide Operator Defined Alarm Thresholds 4.3

4.3.2 Table of wide and narrow threshold setting

The range values in brackets ( ) are the default lower/upper limits activated when
pressing Default in the alarm setting menu refer to Fig. 4.4 Alarm Setting menu. The
values before the bracket ECG 0-350 (50/120) bpm are the low/high system limits.

With the Wide or Narrow Quick Set selection; refer to Fig. 4.4 Alarm Setting menu
all values are derived from the current measured values as shown in the following
table:

HR [bpm] Current measured Wide limits Narrow limits

Patient value Low High Low High
Range: ECG 0 to 350 (50/120) bpm < 60 -20 +35 -10 +25
Range: Pleth 25 to 240 (50/120) bpm 60 to 79 -25 +40 -20 +30
80 to104 -30 +40 -30 +30
≥ 105 -35 +45 -25 +25
Allowed values [30 to 150] [100 to 250] [30 to 150] [100 to 250]
EtCO2 [mmHg]/[%] Low High Low High
Range: 5 to 70 mmHg/0.7 to 9.2%
< 40/5.3 -10/1.3 +15/+2.0 -10/-1.3 +15/+2.0
(30/45 mmHg), (4/5.9%) and (4/6 kPa)
≥ 40/5.3 -10/1.3 +15/+2.0 +15/+2.0 +15/+2.0
[5 to 60] / [20 to 70] / [5 to 60] / [20 to 70] /
Allowed values [mmHg]/ [%]
[0.7 to 7.9] [2.7 to 9.2] [0.7 to 7.9] [2.7 to 9.2]
RR [rpm] Low High Low High
Range: 0 to 60 (8/30) resp/min < 15 -8 +8 -4 +4
≥ 15 -15 +15 -8 +8
Allowed values [5 to 15] [10 to 60] [5 to 15] [10 to 60]
SpO2 [%] Low High Low High
Range: 50 to 100 (92/100)% ≥ 90 -5 --- -5 ---
< 90 -5 --- -5 ---
Allowed values [85 to 100] [90 to 100] [85 to 100] [90 to 100]
NIBP SYS [mmHg] Low High Low High
Range SYS: 30 to 255 (90/160) mmHg < 90 -20 +35 -10 +25
90 to 114 -20 +35 -10 +25
115 to 140 -25 +35 -10 +20
> 140 -25 +35 -10 +20
Allowed values [30 to 245] [30 to 245] [30 to 245] [30 to 245]
NIBP DIA [mmHg] Low High Low High
Range DIA: 15 to 220 (50/90) mmHg
< 65 -15 +25 -10 +25
Art. no: 0-48-0366 Rev: g

65 to 90 -15 +15 -15 +10

> 90 -15 +15 -15 +10
Allowed values [12 to 210] [12 to 210] [12 to 210] [12 to 210]

Page 47
4 Monitoring
4.4 ECG and HR Monitoring DEFIGARD HD-7

4.4 ECG and HR Monitoring

The DEFIGARD HD-7 is intended to monitor 6-lead ECG waveforms HR and record
the ECG.

Intended Users

ACLS: Qualified medical personnel trained for ACLS and trained in the use of the
DEFIGARD HD-7 may use the ECG Monitor operating mode of the DEFIGARD HD-
7.

BLS: Qualified medical personnel trained for BLS and trained in the use of the
DEFIGARD HD-7 may use the HR calculation of ECG Monitor operating mode of the
DEFIGARD HD-7.

Medical Indications: The DEFIGARD HD-7 ECG monitoring module allows for the
identification and interpretation of cardiac rhythms or dysrhythmias and the
calculation of HR (bpm).

• Limitations: None
• Contraindications for the patient: None
• Side-effects: None.

 False diagnosis. Only use silver/silver-chloride electrodes if the patient may

have to be defibrillated while the ECG is displayed. Other electrodes may create
high polarisation voltages, and the ECG trace on the monitor and the recording
may simulate cardiac arrest.
 Danger of destroying the device during defibrillation: The device is only type CF
protected if the original SCHILLER patient cables are used.

Important
• The guidelines for patient electrode placement are provided as an overview only.
They are not a substitute for medical expertise.
• If an electrode is faulty or has come off, a message indicates the faulty electrode.

4.4.1 Quick diagnosis of the ECG using defibrillation electrodes

Isoelectric segments are excluded from the corresponding lead arc duration
measurements (Q, R, S waves). Isoelectric parts (I-wave) are also excluded in the
duration measurement of the respective adjacent waveform.

For a quick diagnosis, the ECG signal can be recorded from the patient's thorax using
the defibrillation electrodes. In all other situations, we recommend acquiring the ECG
via ECG electrodes and the patient cable.
Art. no: 0-48-0366 Rev: g

To apply the electrode pads, refer to section 5.5.1 Adult and paediatric electrodes.

Fig. 4.5 Defibrillation electrodes

Page 48
 Monitoring 4
DEFIGARD HD-7 User guide ECG and HR Monitoring 4.4

4.4.2 Connecting a 4-wire ECG patient cable

The 4-wire cable provides the standard four monitoring (limb) electrode leads.

Refer to the following pages for the electrode placement of the 4-wire cable. Connect
the blanking connector to the cable junction.

When a patient cable and the defibrillation electrodes are connected, you can select
the HR signal source by touching the first curve (standard ECG: II) on the display and
selecting ECG Defi. The first display curve calculates the HR unless the HR source is
set to Pleth.

Red Yellow

Black Green

Fig. 4.6 4-wire cable

4.4.3 Starting ECG monitoring

1. Apply the electrodes as shown in Fig. 4.6 4-wire cable.

2. Connect the patient cable to the ECG signal input (1).
3. Define the ECG settings directly via the touch screen curve or measurement field.
4. Open the HR module (ECG menu) and check the settings.

1
Art. no: 0-48-0366 Rev: g

Fig. 4.7 ECG cable

The sweep speed on the screen and for printing can be set via the ECG menu to 25
or 50 mm/s.

Page 49
4 Monitoring
4.4 ECG and HR Monitoring DEFIGARD HD-7

QRS complexes are represented by green triangles above the top ECG curve external
pacemaker pulses by red vertical dashes.
Curve list with a 4-wire cable
---
Adult Off

Curve List HR
ECG: Defi

ECG: I

ECG: II

ECG: III NIBP

ECG: aVr

NIBP History
Curve list with a 4-wire cable

Curve List
ECG: II ECG Event Screenshot Print Start Menu

ECG: Defi
ECG
Back to Default HR source

Auto Scale OFF

Amplitude

ECG filters

QRS sound level

Curve speed

4.4.4 Monitoring a pacemaker patient

 Erroneous HR display In monitoring pacemaker patients, the possibility of

pacer pulses being counted as QRS complexes cannot be excluded. Therefore,
pacemaker patients should always be watched closely. It is recommended to
monitor pacemaker patients through the plethysmogram HR source = Pleth in
the ECG or SpO2 menu).
 This device can reject double pacemaker pulses having amplitudes from ± 2 to
± 700 mV (± 70 mV) and pulse widths from 0.1 to 2.0 ms (± 0.3 ms)
synchronised with an ECG or without ECG.
Art. no: 0-48-0366 Rev: g

 Patients with a pacemaker must be observed continuously because the HR from

the pacemaker might still be registered in case of a cardiac arrest or some
arrhythmias.
 Pacemaker signals from different pacemakers vary. In the case of cardiac
arrests or some arrhythmias, pacemaker signals might still be measured,
especially signals from pacemakers generating high amplitudes (> 20 mV) or
overshoot. Pacemaker patients must be monitored very closely.

When monitoring the HR of pacemaker patients, the device must only count the QRS
complexes and reject the pacer pulses.

Randomly, some pacemaker pulses could be missing on the display.

Page 50
 Monitoring 4
DEFIGARD HD-7 User guide ECG and HR Monitoring 4.4

Red vertical dashes above the top ECG curve represent pacemaker impulses.

The device has an electronic pacer pulse suppression algorithm that rejects the pacer
pulses, so they are not counted as QRS complexes. Depending on the pacemaker
model used and on the position of the electrodes, the compensation pulse following
every pacer pulse may be considered a QRS complex. In this situation, and when the
pacer pulse is ineffective, the displayed HR may lead to a misinterpretation; the
device does not issue an alarm for bradycardia or asystole. Whether or not the
compensation pulse is counted as a QRS complex depends on the pacer pulse
parameters.

The ECG signal amplitude should be greater than 1 mV for pacemaker patients.

If the source of the HR is SpO2 (1), this is indicated by the blue HR (Pleth)
On
measurement field instead of the green HR measurement field.

Fig. 4.8 Indication HR source SpO2

Art. no: 0-48-0366 Rev: g

Page 51
4 Monitoring
4.4 ECG and HR Monitoring DEFIGARD HD-7

4.4.5 Curve list

Menu Parameter Description Value
Selection of the displayed first curve. The
ECG: I, ECG: II, ECG: III or Defi
Touch first curve first display curve calculates the HR unless
Default: ECG II
the HR source is set to Pleth.
Curve list
ECG: Defi, ECG: I, ECG: II, ECG: III,
Touch the curves 2,3,4 Selection of the displayed curve aVR, aVL, aVF, SpO2, Plethysmograph,
EtCO2: Respiration

4.4.6 HR Module (ECG) settings

Menu Parameter Description Value
Auto, Defi, ECG I, ECG II, ECG III or
Pleth
Source based on which the HR should be If set to Auto, the device will
HR Source
determined a. automatically select the source with
the following priorities: ECG II > ECG
I > ECG III > DEFI > Pleth.
Auto Scale Automatic scale of the ECG amplitude OFF/ON

ECG ECG Curve amplitude ECG amplitude setting 0.25/0.5/1/2 cm/mV

Curve speed ECG speed for screen and printing 25 or 50 mm/s
EMG ON/OFF (electromyogram)
BLW ON/OFF (baseline wandering)
ECG Filter Filter settings For more information, refer to section
11.4.2 Features of pacemaker pulse
rejection.
QRS sound Volume of the systolic sound OFF/Low/Medium/High

a. When the patient has a cardiac pacemaker, the HR source must be set to Pleth (refer to section 4.4.4 Monitoring a pacemaker patient).

4.4.7 ECG Messages

Alarm Cause Remedy
• Electrodes not attached to the  Check the contact between the electrodes and the pa-
patient; come off; bad contact tient.
Cable not detected  Check the ECG cable and electrodes
• Electrodes defective; line break
• The device is defective  Have the device repaired

No Patient • Unable to calculate HR  Check the ECG cable and electrodes

 Check the patient

HR out-of-range • HR is out of the set alarm limit.  Check the narrow/wide HR alarm limit and adjust it if nec-
essary.
Art. no: 0-48-0366 Rev: g

Asystole • No heart rhythm  Physiological alarm. Check the patient.

• Ventricular Fibrillation or Tachy-  Physiological alarm. Check the patient.

VF/VT
cardia

Page 52
 Monitoring 4
DEFIGARD HD-7 User guide Long ECG Recording 4.5

4.5 Long ECG Recording

1. Apply the electrodes of the 4-wire ECG cable as shown in Fig. 4.6 4-wire cable.
2. Connect the patient cable to the ECG signal input.
ECG 3. Press the ECG button. The ECG recording type selection menu appears.
4. Select Start long ECG.
5. The acquisition of the ECG lead II automatically starts. While the acquisition is
ECG running, the button ECG shows the recording symbol.
Start long ECG 6. The recording continues for up to 2 minutes but can be stopped or dismissed by
the user at any time. To do so, press the Recording button and select Stop long
Stop long ECG ECG or Dismiss long ECG.
Dismiss long ECG 7. Once the acquisition is complete, the recording is automatically displayed. Scroll-
ing the Long ECG in the Y-axis for reviewing is now possible by swiping on the
touch screen.

Recording...

Fig. 4.9 Menu ECG recording type

On
HR

Print Print all Close

8. Press Print to print what is displayed on the screen

9. Press Print all to print the entire recording.
Art. no: 0-48-0366 Rev: g

• The ECG speed can be set to 25 or 50 mm/s.

• The ECG amplitude depends on the selected amplitude while performing the
acquisition.

Page 53
4 Monitoring
4.6 SpO2 Monitoring (Option) DEFIGARD HD-7

4.6 SpO Monitoring (Option)

2

The DEFIGARD HD-7 pulse oximeter is intended for continuous non-invasive

monitoring of functional oxygen saturation of arterial haemoglobin and peripheral
pulse. The DEFIGARD HD-7 can be equipped with Medtronic, Nellcor, OxiMax or
Masimo SET SpO2 sensors. The DEFIGARD HD-7 with Masimo SET technology also
indicates the PI.

Intended Users

ACLS: Qualified medical personnel trained for ACLS and trained in the use of the
DEFIGARD HD-7 may use the SpO2 Monitor operating mode of the DEFIGARD HD-
7.

BLS: Qualified medical personnel trained for BLS and trained in the use of the
DEFIGARD HD-7 may use the SpO2 monitor operating mode of the DEFIGARD HD-
7.

Medical Indications: The DEFIGARD HD-7 pulse oximeter is indicated in patients at

risk of hypoxemia.

• Limitations: Perfusion might be limited when a NIBP cuff is inflated if placed on the
same arm as the Oximetry sensor
• Contraindications for the patient: None
• Side-effects: None.

Art. no: 0-48-0366 Rev: g

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DEFIGARD HD-7 User guide SpO2 Monitoring (Option) 4.6

• The pulse oximeter enables the continuous, non-invasive monitoring of functional

oxygen saturation of arterial haemoglobin and the pulse rate. The signal received
from the patient sensor is used to calculate the patient's functional oxygen
saturation and pulse rate.
• The display shows the continuous progress of the numeric SpO2 value, pulse rate,
plethysmographic waveform and signal quality.
• The displayed plethysmographic curve is not proportional to the pulse volume.
• The update period of the measurement readings on the display is 0.2 seconds.
• According to the relevant standards, the temporary alarm suppression must not
exceed 2 minutes.
• Equipment used to perform functional tests cannot be used to indicate the accuracy
of the SpO2 module.
• SpO2 is empirically calibrated in healthy adult volunteers with normal
Carboxyhaemoglobin (COHb) levels.
• The peak wavelength and maximum optical power of the light emitted by the pulse
oximeter probes must be considered in certain cases, for example, when
performing photodynamic therapy. They are as follows:
Masimo
– Range of peak wavelengths: 600 nm to 900 nm
– Maximum optical power output LNCS sensor: < 15 mW
– Maximum optical power output Rainbow sensor: < 25 mW
– Sensors use LEDs that are non-laser with the SpO2 module.
Nellcor
– Range of peak wavelengths: 660 nm to 900 nm
– Maximum optical power output sensor: < 15 mW

Sensors use LEDs that are non-laser with the SpO2 module

• High-intensity extreme lights (such as pulsating strobe lights) directed on the

sensor may not allow the pulse oximeter to obtain vital sign readings.
• Do not loop the patient’s cabling into a tight coil or wrap around the device, as this
can damage the patient’s cabling.
• Additional information specific to the Masimo and Nellcor sensors compatible with
the pulse oximeter, including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's
directions for use.
• Masimo cables and sensors are provided with X-Cal technology to minimise the
risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to
the Cable or Sensor direction of use for the specified duration of the patient
monitoring time.
Art. no: 0-48-0366 Rev: g

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4.6 SpO2 Monitoring (Option) DEFIGARD HD-7

 Only use the SpO2 sensors listed in the order information for the
DEFIGARD HD-7. Other oxygen transducers (sensors) may lead to improper
performance.
 The information in this user guide does not overrule any instructions given in the
sensor's user guide, which must be consulted for full instructions.
 Never use the pulse oximeter as the sole means of monitoring a patient or as an
apnoea monitor; always use the pulse oximeter with an ECG trace.
 Never use a pulse oximeter during MR imaging. Induced current could
potentially cause burns, and pulse oximetry may affect the image and accuracy
of the measurements.
 Tissue damage can be caused by incorrect application or use of a sensor.
Inspect the sensor application location as described in the sensor directions to
ensure skin integrity and correct positioning and adhesion of the sensor.
 Do not use damaged patient cables, sensors, or sensors with exposed optical
components.
 Change the position of the sensor at least every 4 hours and every 2 hours if the
perfusion is low.
 When patients are undergoing photodynamic therapy, they may be sensitive to
light sources. Pulse oximetry may be used only under careful clinical supervision
for short periods to minimise interference with photodynamic therapy.

Art. no: 0-48-0366 Rev: g

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DEFIGARD HD-7 User guide SpO2 Monitoring (Option) 4.6

4.6.1 Inaccurate or incorrect measurement results

 Inaccurate measurements can be caused by:

– Improper sensor application
– Low arterial perfusion
– Motion artefact
– Elevated levels of bilirubin
– Intravascular dyes such as indocyanine green or methylene blue
– A sensor attached to a limb that is already used for NIBP measurement
 Inaccurate SpO2 measurements can be caused by:
– Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur
with a seemingly normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (Oximetry) of a blood sample should be per-
formed
– Elevated levels of dyshemoglobin
– Vasospastic diseases, such as Raynaud’s and peripheral vascular disease
– Hemoglobinopathies and synthesis disorders, including thalassemias, Hb s,
Hb c, and sickle cell.
– Hypocapnic or hypercapnic conditions
– Severe anaemia
– Very low arterial perfusion
– Extreme motion artefact
– Abnormal venous pulsation or venous constriction
– Severe vasoconstriction or hypothermia
– Arterial catheters and intra-aortic balloon
– Intravascular dyes, such as indocyanine green or methylene blue
– Externally applied colouring and texture, such as nail polish, acrylic nails, glitter
– Birthmark(s), tattoos, skin discolourations, moisture on the skin, deformed or
abnormal fingers.
– Skin colour disorders
 Interfering substances: Dyes or any substance containing dyes that change
usual blood pigmentation may cause erroneous readings.
 If SpO2 values indicate hypoxaemia, a laboratory blood sample should be taken
to confirm the patient’s condition.
 If the Low Perfusion message is frequently displayed, find a better-perfused
monitoring site. In the interim, assess the patient and, if indicated, verify
oxygenation status through other means.
 Change the application site or replace the sensor and patient cable when a
Replace the sensor or Replace the patient cable or persistent poor signal quality
message Low SpO2 confidence is displayed on the monitor. These messages
may indicate that patient monitoring time is exhausted on the cable or sensor.
 If using pulse oximetry during full body irradiation, keep the sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be
inaccurate, or the device might read zero for the active irradiation period.
 Variations in haemoglobin measurements may be profound and may be affected
by the sampling technique and the patient's physiological conditions. Any results
Art. no: 0-48-0366 Rev: g

exhibiting inconsistency with the patient's clinical status should be repeated and
supplemented with additional test data. Laboratory devices should analyse blood
samples before clinical decision-making to completely understand the patient's
condition.
 The pulse oximeter may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
 The pulse oximeter may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.

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4.6 SpO2 Monitoring (Option) DEFIGARD HD-7

4.6.2 Starting SpO2 monitoring and test

Replace the cable or sensor when a Low SpO2 confidence message is consistently
displayed while monitoring consecutive patients after completing the troubleshooting
steps listed in this manual. (refer to section 4.6.5 Masimo set error and information
messages SpO2 error Masimo Set and information messages)

Paediatric considerations
Selecting a SpO2 sensor appropriate for the patient's weight is important. For
example, a clean pulse oximetry waveform may not be obtainable when an adult
sensor is used on a small child. Weight-range information can be found in the SpO2
sensor packaging.

1. Select a sensor that is appropriate for the patient’s weight.

2. Apply the SpO2 sensor to the patient. Insert the patient's forefinger fully into the
probe, ensuring the fingertip covers the probe window. This is to prevent extrane-
ous light from reaching the photodetector.
3. Connect the SpO2 sensor to the device.
1 4. Check the bar graph for signal quality (1) (if Masimo SET) and pulsatile activity)
5. Check PI level (3).
6. Set the narrow SpO2 alarm limit; refer to section 4.3 Operator Defined Alarm
Thresholds.
7. An alarm is issued when the SpO2 value exceeds the alarm limit (2).
Set the alarm limit to narrow or wide when the vital data are not critical.

PI (3) with trending capability indicates arterial pulse signal strength and may be used
as a diagnostic tool during low perfusion.
PI display ranges from 0.02% (very weak pulse strength) to 20% (very strong pulse
1 strength).
2
Display -?- or --- instead of the value:
 --- Sensor not connected to the device
3  -?- Sensor not attached to finger

Fig. 4.10 SpO2 measurement field

Art. no: 0-48-0366 Rev: g

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DEFIGARD HD-7 User guide SpO2 Monitoring (Option) 4.6

4.6.3 SpO2 Module Masimo set

Menu Parameter Description Value
Auto, Defi, ECG I, ECG II, ECG III or
Pleth.
Source based on which the HR should be If set to Auto, the device automatically
HR Source
determineda. switches sources with the following
priorities: ECG II > ECG I > ECG III >
DEFI > Pleth.
Definition of the integration time for the
Average 4/6/8/10/12/14/16 seconds
calculation of the displayed average value.
Normal, Maximum, APOD
Select the measurement sensitivity. Select
If set to Maximum and the sensor
SpO2 High when the pulse is weak. Adaptive
becomes dislodged from the patient,
Probe Off Detection (APOD) is optimised
Sensitivity the potential for false readings may
for detecting if a sensor has come off,
occur due to environmental noise
regardless of the signal quality. The setting
such as light, vibration, and excessive
High must not be set as the default setting.
air movement.
Set to match regional power line frequency
Line Frequency to allow for cancellation of noise introduced 50 or 60 Hz
by fluorescent lights and other sources.
Set the pulse tone. The pitch of the pulse
SpO2 Sound level tone also indicates if the saturation level is OFF, low, medium, high
high (high pitch) or low (low pitch).

a. When the patient has a cardiac pacemaker, the HR source must be set to Pleth (refer to section 4.4.4 Monitoring a pacemaker patient).

4.6.4 SpO2 Module Nellcor

Menu Parameter Description Value
Auto, Defi, ECG I, ECG II, ECG III or
Pleth.
Source based on which the HR should be If set to Auto, the device automatically
HR Source
determineda. switches sources with the following
priorities: ECG II > ECG I > ECG III >
DEFI > Pleth.
SpO2 Definition of the integration time for the
Average Normal/Fast
calculation of the displayed average value.
Auto Scale Automatically adjusts the curve amplitude. ON/OFF
Set the pulse tone. The pitch of the pulse
SpO2 Sound level tone also indicates if the saturation level is OFF, low, medium, high
high (high pitch) or low (low pitch).

a. When the patient has a cardiac pacemaker, the HR source must be set to Pleth (refer to section 4.4.4 Monitoring a pacemaker patient).
Art. no: 0-48-0366 Rev: g

4.6.5 Masimo set error and information messages

Alarm Code Cause Remedy

(measurement field)
SpO2: Low SpO2 confidence I.SP203  Check the patient
 Check the sensor and reapply or
The same accounts for • Low pulse signal quality: measurements replace the sensor
Low pulse Confidence I.SP211 are based on poor signal quality. The  If this message is repeatedly dis-
pulse tone, if activated, is low. played, the oxygen saturation
must be verified using another
method.

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4.6 SpO2 Monitoring (Option) DEFIGARD HD-7

Alarm Code Cause Remedy

(measurement field)
Invalid pulse rate  Check the patient
I.SP212 • Invalid pulse rate
 Check the sensor and reapply
 Check the patient
 Check the sensor and reapply. If
• Weak pulse this message is repeatedly dis-
SpO2: Low Perfusion Index I.SP214
• Sensor not properly applied played, the oxygen saturation
must be verified using another
method.
SpO2 Adhesive life near  Replace adhesive in a short term
I.SP222 • Sensor life expired in the near future
expiration
 Check the sensor on the patient,
check the cable connector, elimi-
nate sources of interferences, for
Interference detected I.SP250 • Interferences detected example, high frequency devices
or strong light sources.
 Check Line frequency setting 50 or
60 Hz
Check the cable T.SP231 • No cable connected  Check or replace the cable
T.SP233 • Incompatible cable
T.SP234 • Unrecognised cable
T.SP235 • Defective cable
Check the sensor T.SP236 • No sensor connected  Check the sensor connection
T.SP238 • Incompatible sensor  Check the cable
T.SP239 • Unrecognised sensor  Replace the cable and sensor
T.SP240 • Defective sensor  Contact technical service
T.SP251 • Cable and sensor defective
T.SP254 • Incompatible adhesive sensor
T.SP255 • Unrecognised Adhesive sensor
T.SP256 • Defective Adhesive sensor
T.SP257 • Sensor connection
Invalid functional SpO2 T.SP241 • Sensor incorrectly positioned  Check the sensor

Invalid pulse T.SP242 • Sensor incorrectly positioned  Check the sensor

• Sensor not connected to the patient or  Check the cable connection or re-
Sensor off patient T.SP248 place the cable or sensor
off
 Check that the sensor is correctly
Pulse Search T.SP249 • Device is searching for the pulse
connected to the patient
Options do not match board T.SP293 • Option error  Contact technical service
Art. no: 0-48-0366 Rev: g

T.SP201 to  Contact technical service

T.SP210
and
SpO2 Board defective • SpO2 Board defective
T.SP232
T.SP260 to
T.SP275

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DEFIGARD HD-7 User guide SpO2 Monitoring (Option) 4.6

4.6.6 Nellcor SpO2 error and information messages

Alarm Code Cause Remedy
(measurement field)
SpO2: Low SpO2 confidence I.SP203  Check the patient
 Check the sensor and reapply or
The same accounts for • Low pulse signal quality: measurements replace the sensor
Low pulse Confidence I.SP211 are based on poor signal quality. The  If this message is repeatedly dis-
pulse tone, if activated, is low. played, the oxygen saturation
must be verified using another
method.
Invalid pulse rate  Check the patient
I.SP212 • Invalid pulse rate
 Check the sensor and reapply
 Check the patient
 Check the sensor and reapply. If
• Weak pulse this message is repeatedly dis-
SpO2: Low Perfusion Index I.SP214
• Sensor not properly applied played, the oxygen saturation
must be verified using another
method.
SpO2 Adhesive life near  Replace adhesive in a short term
I.SP222 • Sensor life expired in the near future
expiration
 Check the sensor on the patient,
check the cable connector, elimi-
nate sources of interferences, for
Interference detected I.SP250 • Interferences detected example, high frequency devices
or strong light sources.
 Check Line frequency setting 50 or
60 Hz
Check the cable T.SP231 • No cable connected  Check/replace cable
T.SP233 • Incompatible cable
T.SP234 • Unrecognised cable
T.SP235 • Defective cable
Check the sensor T.SP236 • No sensor connected  Check the sensor connection
T.SP238 • Incompatible sensor  Check the cable
T.SP239 • Unrecognised sensor  Replace the cable and sensor
T.SP240 • Defective sensor  Contact technical service
T.SP251 • Cable and sensor defective
T.SP254 • Incompatible adhesive sensor
T.SP255 • Unrecognised Adhesive sensor
T.SP256 • Defective Adhesive sensor
T.SP257 • Sensor connection
Art. no: 0-48-0366 Rev: g

Invalid functional SpO2 T.SP241 • Sensor incorrectly positioned  Check the sensor

Invalid pulse T.SP242 • Sensor incorrectly positioned  Check the sensor

• Sensor not connected to the patient or  Check the cable connection or re-
Sensor off patient T.SP248 place the cable or sensor
off
 Check that the sensor is correctly
Pulse Search T.SP249 • The device is searching for the pulse
connected to the patient
Options do not match T.SP293 • Option error  Contact technical service

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4.6 SpO2 Monitoring (Option) DEFIGARD HD-7

Alarm Code Cause Remedy

(measurement field)
T.SP400  Contact technical service
T.SP401
Module inoperative T.SP402 • SpO2 board defective
T.SP403
T.SP404
T.SP405  Replace the sensor
Sensor failure • Sensor defective
T.SP406
 Check the cable connection
Check the cable T.SP411 • Sensor disconnected  Check the sensor connection
 Contact technical service
 Check the sensor on the patient,
T.SP424 check the cable connector, elimi-
• Interference, for example, strong light
Interference detected T.SP425 nate sources of interferences, for
source
example, high frequency devices
or strong light sources.
T.SP429 • Sensor not connected to the patient or  Check the cable connection or re-
Sensor off place the cable or sensor
off

T.SP432 • Device did not measure a pulse within a  Check that the sensor is well con-
Pulse timeout nected to the patient
time limit

Art. no: 0-48-0366 Rev: g

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DEFIGARD HD-7 User guide NIBP Monitoring 4.7

4.7 NIBP Monitoring

The DEFIGARD HD-7 is intended to perform non-invasive arterial pressure
measurements using the oscillometric measurement technique to determine systolic,
diastolic, and mean arterial pressures.

Intended Users

ACLS: Qualified medical personnel trained for ACLS and trained in the use of the
DEFIGARD HD-7 may use the NIBP Monitor operating modes of the DEFIGARD HD-
7.

BLS: Qualified medical personnel trained for BLS and trained on the use of the
DEFIGARD HD-7 may use the NIBP Monitor operating modes of the DEFIGARD HD-
7.

Medical Indications: The DEFIGARD HD-7 NIBP module is intended to detect the
presence of hypertension or hypotension in monitored patients.

• Limitations: None
• Contraindications for the patient: None
• Side-effects: Inflation of the NIBP cuff can influence Oximetry measurement if both
sensors are placed on the same arm.

 In case of long-term or frequent monitoring or automatic operation, the

connected body areas of the patient and the extremity to which the cuff is
attached must be checked regularly. Move the cuff regularly to avoid ischaemia,
purpura or neuropathy, especially in patients with decreased pain sensitivity
(due to medication) or older patients with decreased blood circulation of the
extremities. In case of long-term monitoring, move the cuff regularly.
 Too frequent measurements can cause these injuries due to blood flow
interference.

• The non-invasive blood pressure is measured by the oscillometric method.

• The module performs single measurements and automatic measurements at
selectable intervals.
• The automatic measurements are also suitable for pregnant or pre-eclamptic
patients.
• During blood pressure measurements, check that the cuff is on a level with the
heart. If this is not checked, the hydrostatic pressure of the liquid column in the blood
vessels leads to incorrect results. The cuff is automatically at the correct level when
the patient is sitting, standing or supine during measurements.
• Factory default cuff pressure adult = 180 mmHg, children = 150 mmHg,
neonates = 50 mmHg
• The initial cuff pressure is configurable. The maximum cuff pressure configuration
Art. no: 0-48-0366 Rev: g

in neonatal mode is 150 mmHg.

• Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff/stethoscope ausculatory method,
within limits prescribed by the American National Standard, Manual, electronic or
automated sphygmomanometers.

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4.7 NIBP Monitoring DEFIGARD HD-7

 To prevent extensive pressure on the extremity, it is very important to choose

the correct cuff size and check the patient type setting: adult, children or
neonates.
 With neonatal patients, it is important to select first the neonatal mode. A
erroneous mode selection leads to higher pressure, which can cause
haematoma or an osseous deformation.
 When neonatal mode is selected, the maximal pressure is lowered, and the time
measurement is shortened. An erroneous mode selection on neonatal patients
would engender inadequate pressure and time measures.
 In case of long-term monitoring or automatic operation, the connected body
areas of the patient and the extremity to which the cuff is attached must be
checked regularly for signs of ischaemia, purpura or neuropathy, especially in
patients with decreased pain sensitivity (due to medication), or with older
patients with decreased blood circulation of the extremities.
 The cuff must not be attached to a limb that is already used for interventions
such as:
– Infusions
– SpO2 measurement (loss of data can occur during cuff inflation) or
– If an arterio-venous shunt is present.
 To prevent extensive pressure on the extremity and incorrect measurement
results, check that the tube is not kinked or compressed.
 To achieve correct arterial pressure measurement, the cuff must always be
installed on the right atrium level.
 To reduce interferences and the danger of burns for the patient, keep the cuff
and hose as far away as possible from the operated area and the electrosurgical
cables. Check that the electrosurgical return conductor (neutral) is well attached
to the patient and that good contact is guaranteed.
 In some patients, petechiae, haemorrhages or subcutaneous haematomas may
occur. When putting on the cuff, all patients must be told that if they experience
pain during the recording, they should switch OFF the equipment and inform the
doctor.

 When an automated measurement interval is defined, bruising or decreased

blood circulation can occur in the arm. Only carry out recordings with automated
measurement intervals under constant medical supervision.
 It must be certain that, according to the health of the patient, the device does not
damage blood circulation in the arm.

 As with occasional blood pressure measurements, petechial bleeding can occur

in patients with coagulation disorders or having anticoagulant treatment, even
with the correct cuff size.
 The cuff can be placed on the opposite arm in patients with a single mastectomy.
 The cuff must not be placed over or near a wound that could cause further injury.
Art. no: 0-48-0366 Rev: g

 The tube is not pinched or compressed to prevent incorrect measurement

results.
 A cuff applied to a patient in the recumbent or sitting position is normally located
at the same level as the heart. However, if the cuff is located at a level higher
than the heart (for example, if the arm of a patient in bed is lifted), this may result
in lower-than-actual measurement readings (approximately 7.5 mmHg per 10
cm rise).

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DEFIGARD HD-7 User guide NIBP Monitoring 4.7

 The measurement may be inaccurate or impossible:

– If a regular arterial pressure pulse is hard or impossible to detect, for example,
with cardiac arrhythmias, severe shock, hypothermia or with obesity or an
edematous extremity
– With excessive and continuous patient movement such as shivering or convul-
sion.
– The accuracy of the NIBP measurements can be affected by temperature, hu-
midity and altitude extremes.
– If unexpected readings are obtained, follow the procedures below, and if error
messages are displayed, proceed according to section 4.7.6 NIBP Information
and error messages.

4.7.1 Procedure for good NIBP measurements

• Attach the NIBP cuff to the patient. Refer to section 12.2 Accessories DEFIGARD
HD-7 for a list of approved NIBP cuffs. For good quality NIBP measurements, it is
important to use a cuff that is the appropriate size for the patient. Measure the
circumference of the patient's limb and compare this to the size marked on the
NIBP cuff.
• The patient should be sitting or lying down, and the patient's arm or leg should be
relaxed, extended, and resting on a stationary support. A seated patient's legs
should be uncrossed and flat on the floor.
• Wrap the deflated cuff snugly around the patient's arm or leg as required.
• If wrapping around the arm, wrap the cuff at 2 to 5 cm above the elbow crease and
place the artery mark over the patient's brachial artery, pointing to the patient's
hand.
• Instruct the patient to remain quiet and still during the measurement.
• Connect the NIBP cuff to the NIBP hose, and connect the hose to the
DEFIGARD HD-7.
• Start the NIBP measurement by pressing the NIBP START button.
• It is recommended that 5 minutes elapses before the first reading is taken.
• The following is to configure the DEFIGARD HD-7 to take measurements manually
or automatically at pre-set intervals.

4.7.2 Paediatric and neonate considerations

The initial inflation pressure can be adjusted with the patient-type icon. The default for
children = 150 mmHg and for neonates = 50 mmHg

4.7.3 Hypertensive considerations

Art. no: 0-48-0366 Rev: g

For hypertensive patients (for example, systolic pressure greater than 220 mmHg), it
may be necessary to repeat a NIBP measurement if the first attempt is unsuccessful.
The DEFIGARD HD-7 registers the patient’s blood pressure profile from the first
attempt, even if it is unsuccessful, and uses a higher inflation pressure on a
subsequent measurement attempt.

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4.7 NIBP Monitoring DEFIGARD HD-7

4.7.4 Starting NIBP monitoring

1. Note that the cuff size for the respective patient type; refer to section 12.2 Acces-
sories DEFIGARD HD-7.
2. The cuff is attached to the left or right upper arm, about 4 cm above the elbow (on
children a little closer).
1
3. Connect the cuff tubing to the connection sleeve (1) and check that it locks cor-
rectly into place.
4. Define the NIBP settings directly via the Touch screen NIBP measurement field.
– Patient type, adult, child or neonate (indicated at the top right)
5. Open the NIBP menu and check the settings.
– Setting of the Automatic cycle time or manual measurement
6. Start the NIBP measurement by pressing the Start softkey
 To disconnect the cuff tube, press the milled shell of the connecting sleeve
backwards.
Neonate
 Clean and disinfect the cuff after each use; refer to sections 10.5 Cleaning and
10.6 Disinfection.
NIBP Module
The following settings are available for the cycle time:
Automatic Cycle
Automatic Cycles 2/3/5/10/15/30 minutes
Manual
Manual The measurement is manually initiated by pressing the softkey.
Venous Block Venous Block The venous block is used to apply intravenous access. The
pressure is 80 mmHg. The blockage time is limited to 80 sec-
ond. You can stop the blockage at any time by pressing the
NIBP Stop key.

Off
Adult

HR

NIBP NIBP History

START

V. BLOCK
1:30
ECG Event Screenshot Print Start Menu

Bar graph of applied pressure

Remaining time until the next NIBP
measurement
Art. no: 0-48-0366 Rev: g

• When the measurement is started, the increasing cuff pressure is displayed on the
bar graph.
• The last four measurements are displayed in the window.
• The latest NIBP measurement is always displayed in the NIBP parameter box.
Should the value be older than 5 minutes, the value is displayed in yellow.

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DEFIGARD HD-7 User guide NIBP Monitoring 4.7

4.7.5 NIBP Menu

Menu Parameter Description Value
Automatic cycle of 2/3/5/10/30
NIBP Automatic cycles Cycle time setting
minutes
The measurement is manually initiated by
Manual softkey = Start
pressing the softkey.

4.7.6 NIBP Information and error messages

NIBP Alarm Code Cause Remedy
T.NIBP01  Replace the device
to
Module inoperative • NIBP module failed
T.NIBP07 &
T.NIBP21

• No pressure can be measured  Check the cuff and the connection.

Unable to inflate cuff T.NIBP08
• The device is defective  Replace the device

T.NIBP09  Check the cuff and the connection for

• Pressure/pulse below/above
Invalid measurement T.NIBP10 leaks
limits
T.NIBP11

• No signal/pulse detected at  Check the patient, cuff and the hose

Unable to measure T.NIBP12
50 mmHg

• Pressure in the cuff remains too  Check the cuff and the connection for
Cuff not present T.NIBP13 low, < 10 mmHg during 10 sec- leaks
onds

• Pressure too high because  Check the cuff and the connection.
Wrong cuff T.NIBP14 - Too small cuff applied
- Tube buckled

T.NIBP15 • Measurement disturbed by ex-  The patient must not move during meas-
Artefacts detected urement
T.NIBP16 ternal influences

• Measurement time exceeded  Check the cuff and the connection.

Measurement timeout T.NIBP17
with no results  Check that the cuff is correctly fitted

T.NIBP18 • Pumping running time exceed-  Check the cuff and the connection for
Inflate timeout leaks.
T.NIBP19 ed

• Pressure below/above accept-  Check the patient, cuff and hose

Pressure out-of-range T.NIBP20
able range

No cuff T.NIBP22 • No cuff detected  Connect the cuff

T.NIBP23  Check the cuff and the hose

• Systolic/diastolic adult/neonate
Art. no: 0-48-0366 Rev: g

SYS/DIA out-of-range to  Contact technical service

out of measuring range
T.NIBP23
 Check that the cuff is correctly fitted
No pulse I.NIBP01 • No pulse detected
 Check the patient, cuff and the hose

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4 Monitoring
4.8 CO2 Sidestream DEFIGARD HD-7

4.8 CO Sidestream
2

The DEFIGARD HD-7 is intended for continuous non-invasive measurement and

monitoring of carbon dioxide concentration of the expired and inspired air. It reports
the amount of CO2 present at the end of exhalation (EtCO2) and the RR. EtCO2 is
delivered as a percentage (%), mmHg or kPa. RR is delivered in breaths per minute.

Intended Users

ACLS: Qualified medical personnel trained for ACLS and trained in the use of the
DEFIGARD HD-7 may use the Capnography Monitor operating mode of the
DEFIGARD HD-7.

Medical Indications: The DEFIGARD HD-7 EtCO2 function can be used to monitor
spontaneous breathing or suffocation in acute care.

• Limitations: None
• Contraindications for the patient: None
• Side-effects: None.

4.8.1 ISA gas analyser (sidestream measurement)

• ISA sidestream gas analyser is intended to be connected to a patient breathing

circuit for monitoring of inspired/expired gases during anaesthesia, recovery and
respiratory care.
• A correction related to O2 usage is available in the menu setting EtCO2 >Type of
ventilation. If the patient is ventilated with Air and O2, set the Type of ventilation
to = Air + O2. If ventilated only with air, set it to Air.

Art. no: 0-48-0366 Rev: g

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 Monitoring 4
DEFIGARD HD-7 User guide CO2 Sidestream 4.8

 The ISA sidestream gas analyser is intended for use by authorised healthcare
professionals only.
 Disposable sampling lines must not be reused. Used sampling lines should be
disposed of in accordance with local regulations for contaminated and
biologically hazardous fluids.
 Do not re-use the Nomoline sampling line due to cross-contamination risk.
 Only use Masimo´s Nomoline sampling lines.
 Do only use sample lines intended for anaesthetic agents if N2O or anaesthetic
agents are being used.
 Check that the correct configuration is selected:
– Do not use a T-adapter for infants or neonates, as this adds 7 ml of dead space
to the patient circuit.
– Do not use the NomoLine Airway Adapter Sets adult/paediatric for infants/neo-
nates as the adult/paediatric Airway Adapter adds 6 ml dead space.
– Do not use the Nomoline Airway Adapter Set infant/neonate with adult/paediat-
ric patients as they may cause excessive flow resistance (0.7 ml dead space).
 Use only airway T-adapters with the sampling point in the centre of the adapter;
see left.
 Do not use the sampling lines with metered-dose inhalers or nebulised
medications, as this may clog the bacteria filter.
 The ISA sensor is not intended to be used as the only means of monitoring a
patient.
 The ISA sidestream measurements should not be used as the sole basis for
medical decisions. It must be used in conjunction with clinical signs and
symptoms.
 Excessive positive or negative pressure in the patient circuit (for example,
excessive scavenging suction pressure) might lead to incorrect readings.
 Properly apply sampling lines according to the sampling line direction for use. A
misapplied sampling line that becomes partially dislodged may cause no or
incorrect readings.
 Exhaled gases should be returned to the patient circuit or scavenging system;
do not apply negative pressure to the Nomoline (that is, by means of a syringe)
to remove condensed water.
 Always use a bacteria filter on the evacuation side if sampled gas is intended to
be re-breathed.
 The use of high-frequency electro-surgical equipment in the vicinity of the ISA
sensor may produce interference and lead to incorrect measurements.
 Exhaust gases should be returned to the patient circuit or a scavenging system.

 The Nomoline sampling line and its interface are non-sterile devices. To avoid
damage, do not autoclave any part of the sampling line.
 Do not operate the device at temperatures outside the specified operating
environment.
Art. no: 0-48-0366 Rev: g

 Make sure that the ISA sensor is properly secured in order to prevent damage
to the sensor.
 The use of a sampling line with an inner diameter of more than 1 mm can lead
to a change in the response and rise time of the CO2 measurement. When the
RR is higher than 130 minutes, this might lead to a lower EtCO2 value being
displayed.

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4 Monitoring
4.8 CO2 Sidestream DEFIGARD HD-7

 The Nomoline sampling line is designed for single use only; do not reuse.
 Do not re-use the Nomoline sampling line due to cross-contamination risk.
 Nomoline Family sampling lines shall be disposed of as bio-hazardous waste.
 The NomoLine Family sampling lines are divided into two application categories:
– NomoLine LH (Low-Humidity) – Single-patient-use sampling lines for short-
term applications in low-humidity conditions.
– NomoLine HH (High-Humidity) – Single-patient-use sampling lines for long-
term applications in high-humidity conditions.
 The NomoLine sampling lines are designed to either collect (LH) or remove (HH)
condensed water and incorporate a bacteria filter that protects the gas analyser
from water intrusion and cross-contamination.

4.8.2 Initial operation of the ISA gas analyser

• The sensor requires a warm-up time of around ten seconds.

1. Connect the Nomoline sampling line (1) to the ISA gas analyser.
2. A green LED (2) indicates that the sensor is ready for use.
Green/ 3. Select the EtCO2 measurement field (3) to open the EtCO2 menu.
Red LED 4. Select the OFF/ON button to start the measurement.
2 5. Breathe briefly into the sampling line and check that the CO2 curves and values
are displayed correctly.
6. Occlude the sampling line with your fingertip and wait for 10 seconds.
1 Nomoline 7. Check that an occlusion alarm is displayed and that the gas analyser shows a
sampling line flashing red light.
3

 Replace the sampling line if the sampling line input connector (2) starts flashing
red or the message “Sampling line clogged” is displayed on the device.
Start measurement ON
 Connect the gas sample exhaust port to the scavenging system of the
Curve amplitude (%)
hospital.

Type of ventilation
Air

EtCO2
Art. no: 0-48-0366 Rev: g

4.8.3 Sensor LED indications

In addition to the information given on the screen, the sensor LED indicates the
following:

Steady green: System OK

Flashing green: Zero reference calibration in process
Steady blue light: Anaesthetic agent present
Steady red: Sensor error
Flashing red: Check/replace the sampling line

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 Monitoring 4
DEFIGARD HD-7 User guide CO2 Sidestream 4.8

4.8.4 Nomoline family sampling line (water trap) replacement

 Dispose of the Nomoline Family sampling lines in accordance with local

regulations for biohazardous waste.

 NomoLine Family sampling lines should be replaced according to good clinical

practice, but at the latest, after 2 weeks or when the sampling line gets occluded.
– Occlusion occurs when water secretion, for example, aspires from the respira-
tory circuit to such an extent that ISA cannot maintain the normal 50 ml/min
sample flow. This situation is indicated by a red flashing gas inlet connector
and an alarm message.
 Replace the NomoLine and wait until the gas inlet connector switches to green,
indicating that the ISA gas analyser is ready for use.

4.8.5 RR alarms and messages

Alarm Code Cause Remedy
P.ETCO201  Check the patient
 Check the narrow/wide EtCO2 alarm limit
RR out-of-range • RR out of set alarm limits.
and adjust it if necessary.
 Check the ventilation settings
P.ETCO202  Check the patient
 Check the narrow/wide EtCO2 alarm limit
Apnoea • Apnoea out of set alarm limits.
and adjust it if necessary.
 Check the ventilation settings
P.ETCO203  Check the patient
 Check the narrow/wide EtCO2 alarm limit
CO2 out-of-range • EtCO2 is out of set alarm limits.
and adjust it if necessary.
 Check the ventilation settings
I.ETCO201 • An offset in gas readings is dis-  Perform zeroing
CO2 calibration required
covered
T.ETCO201 • No Sensor connected, defective  Connect the sensor and check the cable
Check the sensor
cable

Zeroing in progress T.ETCO202 • Zeroing process started  Wait until the zeroing process ends

T.ETCO207 • Indicates sampling line occlu-  Replace the sampling line

Sampling line clogged
sion.
T.ETCO208 • Indicates that a sampling line  Check if IRMA CO2 adapter is properly
No sampling line connected
needs to be fitted.

Internal O2 port failure T.ETCO209 • Sensor failure  If persistent, replace the sensor
Art. no: 0-48-0366 Rev: g

T.ETCO214  Check the standard operating conditions if

• Sensor temperature too high/ normal:
Internal temp out-of-range
low
 Replace the sensor
T.ETCO215  Check the standard operating conditions if
Ambient pressure out-of- normal:
• Pressure too high/low
range
 Replace the sensor
T.ETCO216  Check the standard CO2 conditions if
• This alarm is due to Zeroing re-
Inaccurate zero reference normal:
quired message from the probe.
 Perform zeroing
Software error T.ETCO218 • Sensor failure  Check the sensor/replace the sensor

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4 Monitoring
4.8 CO2 Sidestream DEFIGARD HD-7

Alarm Code Cause Remedy

Hardware error T.ETCO219 • Sensor failure  Check the sensor/replace the sensor

Motor speed out of bounds T.ETCO220 • Sensor failure  Check the sensor/replace the sensor

Factory calibration lost T.ETCO221 • Sensor failure  Check the sensor/replace the sensor

4.8.6 Settings EtCO2 menu

Access the EtCO2 menu via the EtCO2 display field as shown in 4.8.2 Initial operation
of the ISA gas analyser.

The default settings are printed in bold.

Menu item Parameter Description

Start measurement ON or OFF
Curve amplitude (%) 8, 12 or 15%
Air = patient ventilated only with Air
Type of ventilation Air + O2 = patient ventilated with Air and O2

4.8.7 Curve list

Menu Parameter Description Value
Selection of the displayed first curve. The
ECG: I, ECG: II, ECG: III or Defi
Curve list Touch the first curve first displayed curve is used to calculate the
Default: ECG II
HR unless the HR source is set to Pleth.
ECG: Defi, ECG: I, ECG: II, ECG: III,
Touch the curves 2,3,4 Selection of the displayed curve aVR, aVL, aVF, SpO2,
Plethysmograph, EtCO2: Respiration

4.8.8 Zeroing of the CO2 sidestream sensor

 Incorrect zero adjustment leads to erroneous measurement results.

 Therefore, make sure that the calibration is performed in a well-ventilated room.
Avoid breathing near the gas analyser exhaust before or during the calibration.

Art. no: 0-48-0366 Rev: g

• The ISA sidestream gas analyser performs zeroing automatically by switching the
gas sampling from the respiratory circuit to ambient air. The automatic zeroing is
performed after startup and 1 to 3 times per day, and it takes less than 3 seconds.
• During zeroing, if ISA’s exhaust gas is returned to the patient circuit, the returned
gas level is different from the gas level at the sampling site.

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 Monitoring 4
DEFIGARD HD-7 User guide Registering Events 4.9

4.9 Registering Events

When the event button is pressed, the pre-defined event texts are displayed. Select
one of these texts; this text is recorded in the data report together with the time.
Events
 Select Cancel last to indicate that an incorrect event was selected. A Cancel Last
event and timestamp are stored in the event list.

Fig. 4.11 Event button

The events can be printed with the thermal printer from the Menu/Review Events.

Data (ECG, automatic and manual events) can be displayed on a PC by use of the
SCHILLER data reviewing software.

4.10 View Trends, Events and Screenshots

All recorded trend data, Long ECGs and screenshots can be viewed, printed or
transmitted (transmitting only screenshots) during an intervention.

4.10.1 View trends

Trends are displayed with a standard interval of 2 minutes. However, each NIBP
measurement adds an additional column independently from the standard interval.

1. Enter the main menu and select Trends.

2. Use the function buttons to navigate in the trend screen.
Menu
Trends
14/09/19 12:00 12.02 12:04
Menu HR
bpm 80 85 81 79
View 6-lead HR (Pleth)
bpm --- --- --- ---
SpO2
Long ECG % 98 98 97 96
NIBP 120/80(88) 125/81(89) ---/---(--) ---/---(--)
Screenshots mmHg

Trends

Review Events
Beginning Backward Print Forward End Close
Art. no: 0-48-0366 Rev: g

3. Select the Print table to get a printout on the thermal printer.

4. Close the Trends screen with the or Close button.

Fig. 4.12 Trends screen

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4 Monitoring
4.10 View Trends, Events and Screenshots DEFIGARD HD-7

4.10.2 View, print and transmit screenshots

You can execute a screenshot manually with the function button, or the device
captures screenshots automatically in the following cases:

• Shock delivery
• Switch modes
• Pacer ON/OFF
• ECG alarm (VF/VT, Asystole)

View screenshots

1. Enter the main menu and select Screenshot

2. Select one of the screenshots in the list.
3. The screenshot appears with a watermark.
4. Exit the viewing mode by pressing the Red X button in the top left corner.

Print or transmit screenshots

Transmitting via Wi-Fi is only possible when a connection to an access

point is established (see the icon on the screen)

 To print or transmit a screenshot, tick the box on the right and click on Next.
Several screenshots can be selected and printed, transmitted via Wi-Fi (email) or
stored on a USB stick.
 The screenshot is available for printout only when the icon has switched from
camera to camera + printer
 The printout files may take some time to be generated.

4.10.3 View and print events

You can execute an event manually with the function button, or the device
automatically records events in the following cases:

• Shock delivery
Art. no: 0-48-0366 Rev: g

• Switching modes
• Pacer ON/OFF
• ECG alarm (VF/VT, Asystole)

Page 74
 Monitoring 4
DEFIGARD HD-7 User guide View Trends, Events and Screenshots 4.10

1. Enter the main menu and select Review Events

2. The following screen appears

P Print events
Menu

Menu
View 6-lead

Long ECG

Screenshots

Trend

Review Events

3. Select the Print events button to print all events.

4. Exit the viewing mode by pressing either the Back or Menu button.
Art. no: 0-48-0366 Rev: g

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5 Defibrillation
5.1 Application Guidelines and Safety Notes DEFIGARD HD-7

5 Defibrillation
5.1 Application Guidelines and Safety Notes
Observe the following guidelines to ensure successful and safe defibrillation.
Otherwise, the lives of the patient, the user and bystanders are in danger.

 The patient must:

– Not come into contact with the operator or other persons during defibrillation.
– Not come into contact with metal parts, for example, bed or litter, or be posi-
tioned on wet ground (rain, accident in swimming pool) to prevent unwanted
pathways for the defibrillation current, which may endanger the operator or as-
sistants.
 Do not allow the defibrillation electrodes to come into contact with other
electrodes or metal parts which are in contact with the patient.
 The patient's chest must be dry, as moisture causes unwanted pathways for the
defibrillation current. For safety, wipe off flammable skin cleansing agents.
 Owing to the high currents, there is a risk of skin burns at the site of the
electrodes. This is why the electrodes must not be placed on or above:
– The sternum, clavicle or mamillas
 Immediately prior to the shock, the heart massage, CPR and artificial respiration
must be stopped, and bystanders must be warned.
 Defibrillating a patient with an implanted pacemaker is likely to impair the
pacemaker’s function or cause damage to the pacemaker. For this reason, do
not apply the defibrillation electrodes in the vicinity of the pacemaker. AHA and
ERC’s last guidelines for ALS recommend, when treating an adult with a
permanent pacemaker or an ICD, that the defibrillator external paddles/pads
should be placed on the chest wall, ideally at least 8 cm from the generator
position. Moreover, both the anterior-lateral and anterior-posterior paddle/pad
placements on the chest are acceptable in patients with a permanent pacemaker
or ICD. Have an external pacemaker at hand. After restoration of the
spontaneous circulation, pacemakers should always be checked for possible
damage.
 Defibrillation has to be performed with the adapted accessories according to the
type of patient.

 Equipment damage. Sensors and devices that are not defibrillation-proof must
be disconnected from the patient before a shock is triggered.
Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Application Guidelines and Safety Notes 5.1

5.1.1 Additional safety information for AED mode

In addition to the guidelines detailed in section 5.1 Application Guidelines and Safety
Notes, the following rules must be observed when using an AED, as failure to do so
may compromise the success of the defibrillation or endanger the patient's life.

 The user is committed to verifying the prerequisites for the use of the AED by
checking for lack of consciousness, lack of breathing and lack of circulatory
signs using the ABCD system (BLS algorithm).
 The device must only be used if the following symptoms are found:
– Non-responsive
– No respiration
– No pulse
 If, in the course of treatment, a patient spontaneously regains consciousness, a
defibrillation shock that may have been advised just before must not be
delivered.
 For the correct analysis of the heart rhythm, the patient must lie as still as
possible and must not be touched, as artefacts may lead to incorrect analysis
results.
 If the ECG signal changes such that the shock is not recommended, the shock
delivery is automatically blocked in the AED mode.
 AED mode is not possible with paddles.
 Some non-shockable rhythms of patients in cardiac arrest may interrupt the
analysis process.
 Using a defibrillator in AED mode on a patient with an implanted pacemaker can
interfere with the SAS and lead to false decisions related to patient treatment
advice.
 The agonal respiration phenomenon (GASP) of a patient in cardiac arrest may
interrupt the analysis process.
 Using a defibrillator in AED mode in a moving vehicle can interfere with the SAS
and lead to false decisions related to patient treatment advice. It is advised to
stop the vehicle to run any shock advisory analysis.

 The presence of chest compressions during the analysis may interrupt the ECG
analysis.

5.1.2 Additional safety information for internal defibrillation (spoons)

In addition to the guidelines detailed in section 5.1 Application Guidelines and Safety
Notes, the following rules must be observed when using spoons for internal
defibrillation, as failure to do so may compromise the success of the defibrillation or
endanger the patient's life.
Art. no: 0-48-0366 Rev: g

 Patient hazard. Use only sterilised spoon electrodes for internal defibrillation.
Note that the spoons must be sterile at the moment of use.
 Do not use the internal defibrillation spoons apart from open chest surgical
procedures.

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5 Defibrillation
5.1 Application Guidelines and Safety Notes DEFIGARD HD-7

 Operating a device with defective spoons and cables constitutes a danger to the
patient or the user. Therefore:
– Immediately replace damaged spoons and cables. Damaged or missing com-
ponents must be replaced immediately.
– The selection of the appropriate internal spoon diameter for therapeutic purpos-
es is the responsibility of the user.
– Make sure that the connection cable is connected to the spoon electrodes. The
connection cable can be used with interchangeable spoon electrodes of various
sizes.
 The patient can be endangered by too high leakage currents (summation of
leakage currents):
– Several devices are connected to the patient
– Other equipment than the CPR sensor is connected to the USB connector.
For this reason, devices that are not required should be disconnected from the
patient, and only equipment approved by SCHILLER may be connected to the
device.

5.1.3 Defibrillating children/neonates

 Note that less energy is needed for children:

According to the guidelines, a biphasic shock of 2 to 4 joules/kg is recommended
for the defibrillation of infants and small children.
 For the defibrillation of children, paediatric pads should be used.
 If no paediatric pads are available, adult electrodes can be used when patient
type Child/Neonate has been selected. Warning. Double-check that the patient
type setting and type of electrodes is Child/Neonate. (see illustration points 1 and
2 below).

Defibrillation on neonates
 When using the defibrillator on neonates, follow the local guidelines.
 Follow the recommended energy setting for infants and small children as
described above.
 The automatic energy setting for neonates is the same as for children.

Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Application Guidelines and Safety Notes 5.1

When paediatric pads are used, the patient type setting Adult or Child/Neonate on
the screen does not overrule the energy setting. When paediatric pads are
connected to the device, the energy setting is always paediatric.
Paediatric Patient type Electrode/energy setting
electrode information

50/50/50 joules

If no children electrodes are available, adult electrodes can be used. When adult pads
are used, the patient type setting Child/Neonate on the screen does overrule the
energy setting Adult to Child/Neonate.
Adult Patient type Electrode/energy setting
electrode information

150/200/200 joules

1 50/50/50 joules

2 50/50/50 joules
Neonate
Art. no: 0-48-0366 Rev: g

Page 79
5 Defibrillation
5.2 General Function DEFIGARD HD-7

5.2 General Function

• The DEFIGARD HD-7 works with Multipulse Biowave biphasic truncated
exponential chopped defibrillation waveform impulse.
• Depending on the factory settings, the device either switches automatically from
synchronised to non-synchronised defibrillation, or the mode has to be changed
manually using the Sync button.
• When a patient cable is connected, you can select in the ECG menu if the ECG
should be displayed via the separate ECG electrodes or the defibrillation
electrodes.
• You can select a higher energy value while the defibrillator is charging, The device
charges to the new level. It is not possible, however, to reduce the charged energy.
In this case, the stored energy is discharged internally, and you have to recharge
the defibrillator.
• The required energy for a successful defibrillation depends on several parameters
(for example, body constitution). For emergency medical treatment, AHA/ERC
recommend a biphasic impulse. Depending on configuration settings, the energy
of the 3 first shocks can be increased.

Shock Adults Children

1 150 joules 50 joules

2 200 joules 50 joules
from 3 200 joules 50 joules

Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide General Function 5.2

5.2.1 Activating the manual defibrillation mode

1. Select Manual Defibrillation (1).

Number of released shocks

Elapsed time since the
last shock
Indication of pad type Child or Adult Electrode impedance

Elapsed time since manual

defibrillation is active Manual adults. Low

Switching operational modes:

synchronous (Sync) or
asynchronous (aSync) Cancel

Charging progress bar

CPR Event Print

Charging button
Opening CPR menu to: Selection of energy via -
or + button
• Set the metronome behaviour
• Activating/deactivating CPR feedback Cancel

Print

5.2.2 Activating the automated (AED) defibrillation mode

The timer counts down from the start of the CPR. Depending on the configuration. The
timer can be started manually by pressing the area or automatically.
Art. no: 0-48-0366 Rev: g

1. Select AED defibrillation.

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5 Defibrillation
5.2 General Function DEFIGARD HD-7

In AED mode, the alarm system remains active in the same state as in the monitoring
operational mode.

The Timer counts down from the start of the CPR

Number of released shocks

Elapsed time since the last shock Electrode impedance

ECG curve displayed when the Pause

option is activated

Indication of pad type

Elapsed time since AED active

Text instruction 30 CHEST COMPRESSIONS

THEN 2 RESCUE BREATHS

Opening CPR menu to: CPR Event Screenshot Print Analyse Menu

• Set the metronome behaviour Action picture

Green Triangle = QRS trigger
• Activating/deactivating CPR feedback Red mark = external pacer pulse
Analyse softkey

Off

It has the same AED display as above

but with a parameter displayed on the COMPRESSION
RECOIL
DEPTH
right side. This view is defined by
good
administrator configuration. 30 CHEST COMPRESSIONS
THEN 2 RESCUE BREATHS MESSAGE

OK

CPR Event Screenshot Print Analyse Menu

 Switching from AED mode to Monitor mode must be confirmed with Yes .
This depends on the device’s configuration (refer to section 11.6.1 General
configuration)
Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide General Function 5.2

5.2.3 AED layouts

Depending on user needs, the AED display can be modified:

• Enable/Disable curves display (2 curves, typically DEFI and EtCO2 or SpO2)

• Enable/Disable vitals display

PLUG AND
APPLY ELECTRODES

The screen shows a disabled curve and vital signs. For another example; refer to the
CPR Events Screenshots Print Menü
previous page.

5.2.4 Manual defibrillation procedure

1. Select manual defibrillation (refer to section 5.2.1 Activating the manual defibrilla-
tion mode)
 Confirm switching to manual defibrillation (This depends on the device’s
configuration; refer to section 11.6.1 General configuration.
2. Select the required energy using buttons + or - joules buttons.
3. Charge the energy using the Charge button either on the touch screen or on the
device.
4. Trigger the shock by pressing the shock button on the device.

Charge Cancel

CPR Event Screenshot Print

Disarm
Cancel

AED
Print
Art. no: 0-48-0366 Rev: g

Fig. 5.1 Defibrillator window

To disarm the manual defibrillator while the defibrillator is charging or when the shock
is ready to be delivered, proceed as follows:

1. Press or the Disarm button.

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5 Defibrillation
5.3 Manual Defibrillation using Paddles DEFIGARD HD-7

5.3 Manual Defibrillation using Paddles

 Delivering a shock to a patient with a normal heart rhythm may induce VF. For
this reason, first read the general rules and safety information in section
5.1 Application Guidelines and Safety Notes.
 Electric shock hazard. Turn OFF the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an
internal safety discharge.
 Do not apply electrode gel to the patient's skin. Danger of short circuit between
the paddles.
 Do not short-circuit the paddles.

• The defibrillation shock can be triggered only when the electrodes are applied to
the patient and the skin resistance does not exceed a certain level (Ohm LED lights
green). Otherwise, the energy is discharged internally when the shock is released.
• When the shock is not delivered within 20 seconds of charging, it is discharged in-
ternally.

Resistance indicator Energy selectors +/-

Charge button

Start/Stop Event
print button
Shock buttons

Art. no: 0-48-0366 Rev: g

Turn both adult clip electrodes Paediatric paddle

90° and remove it

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 Defibrillation 5
DEFIGARD HD-7 User guide Manual Defibrillation using Paddles 5.3

1. Make sure the paddles (1) are connected. Disconnect pads (2) first, if necessary.
2. Remove the paddles from their compartments.
1 3. For children, remove the adult clip electrodes.
4. Carefully dry the paddles and the handles if they are wet.
5. Apply an ample amount of electrode cream to the paddle surfaces.
6. Apply the paddles as shown in Fig. 5.2 Paddle application:
STERNUM: right sternal edge at the level of the 2nd intercostal space.
2 APEX: left axillary line at the level of the 5th intercostal space
Note that when the skin resistance is within the allowed limit, the indicator on the
Sternum paddle lights green
7. Select the required energy via the + or - selection button.
8. Initiate charging by pushing the blue Charge Button on the Apex paddle. The bar
diagram shows the energy charging process.
9. Do not touch the patient any more and warn all those present.
10. As soon as the charging process is completed,
– A beep sounds.

– The message is displayed

OK
– The two shock keys on the paddles light up
11. Press the paddles firmly down onto the thorax.
12. Simultaneously press both shock buttons on the paddles.
Keys for energy charging and release After delivery of the shock, the audio signal stops, and the printer starts (if config-
of the defibrillation impulse ured). The printout can be stopped at any time by pressing the yellow print button
on the Sternum paddle.
13. Monitor the patient’s ECG.
14. When no further shocks are required, switch the energy selection button back to
0 and turn the device OFF.
15. To finish the therapy; refer to Chapter 7 Finishing the Therapy.

Energy selection key

Skin resistance OK when LED is lit

Key for energy release of the defibril-

lation impulse
Art. no: 0-48-0366 Rev: g

Fig. 5.2 Paddle application

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5 Defibrillation
5.4 Manual Defibrillation using Spoons DEFIGARD HD-7

5.4 Manual Defibrillation using Spoons

The feature, internal defibrillation with a spoon, is only available with the host
software version Soft01BXX or higher.

 If the DEFIGARD HD-7 is used for internal defibrillation and the spoon cable is
permanently connected, the maximum energy tested will be 50 joules. If the
DEFIGARD HD-7 is used for anything other than internal defibrillation, a full self-
test should be performed without the spoon cable connected.

 Delivering a shock to a patient with a normal heart rhythm may induce VF. For
this reason, first read the general rules and safety information in section
5.1 Application Guidelines and Safety Notes.
 Electric shock hazard. Turn OFF the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an
internal safety discharge.
 Patient hazard.Use only sterilised electrodes for internal defibrillation. Note that
the electrodes must be sterilised before each use (refer to Chapter 10
Maintenance).

• The defibrillation shock can only be triggered when the spoon electrodes are ap-
plied to the patient and the skin resistance does not exceed a certain level. Other-
wise, the energy is discharged internally when the shock is released.
• When the shock is not delivered within 20 seconds of charging, it is discharged in-
ternally.
• Spoon-shaped electrodes, whose contours must match the dimensions of the
heart, are used for internal defibrillation. The spoon surface must make full contact
with the heart. Spoons are available in five different sizes (refer to the accessories
information). As the spoons are in direct contact with the heart, less energy is
required than for external (transthoracic) paddles or pads application. Therefore,
the defibrillator does not accept energy settings above 50 joules. The following
energy levels are available: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 30,
50 joules.

Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Manual Defibrillation using Spoons 5.4

Adapter cable

5.4.1 Manual defibrillation procedure using spoons

• Refer also to section 5.2.4 Manual defibrillation procedure for details.

• This procedure requires two qualified persons to operate:
– One person to position the spoon electrodes on the patient's heart, and a sec-
ond person (User 2) to operate the controls on the defibrillator.

 The person with the spoons takes the lead in the defibrillation procedure.
 The communication procedure between the two people must be trained,
especially for instructions 3, 4, 6 and 8. See below.

1. Check that the adapter is connected to the device and that the spoon electrodes,
connection cable and adapter are connected. Disconnect pads or paddles first, if
necessary.
2. Position the spoons on the heart.
Note that when the skin resistance is in the allowed limit, the indicator on the
Art. no: 0-48-0366 Rev: g

screen shows
OK

User 2 3. Select the energy using the + or - joules buttons.

User 2 4. Initiate the energy charge by pressing Charge

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5 Defibrillation
5.4 Manual Defibrillation using Spoons DEFIGARD HD-7

5. As soon as the charging process is completed,

– A beep sounds

– The message is displayed.

OK

 Danger of electric shock

Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.

User 2 6. Trigger the shock by pressing the Shock button on the device.
7. Monitor the patient's ECG after delivering the shock.
User 2 8. When no further shocks are required, switch the energy selection button back to
0 and turn the device OFF.
9. To finish the therapy; refer to Chapter 7 Finishing the Therapy.

Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Defibrillation using Pads 5.5

5.5 Defibrillation using Pads

 Delivering a shock to a patient with a normal heart rhythm may induce VF. For
this reason, first read the general rules and safety information in sections.
5.1 Application Guidelines and Safety Notes and 5.2 General Function.
 Electric shock hazard. Turn OFF the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an
internal safety discharge.

5.5.1 Adult and paediatric electrodes

 Only use the pads up to their expiration date. Note that the indicated expiration
date only applies if the vacuum pack is intact.
 The pads are pre-gelled, so there is no need to use an extra contact agent.
 Do not reuse the pads.
 The placement of pads is different for defibrillation or external pacing. Refer to
section 6.3.1 Attaching the pacer pads)
 The placement of pads may be different if the patient is an adult or a child.

Adult and paediatric electrodes

• Pads can be used in AED, manual defibrillator, and external pacing operating
modes.
• If no children electrodes are available, adult electrodes can be used. When adult
pads are used, the patient type setting Child/Neonate on the screen does overrule
the energy setting Adult to Child/Neonate. The pads positioning anterior-posterior
shall be observed.

Large electrodes The large electrodes (80 cm2) are to be used for adults and children from 25 kg body
weight.

Small electrodes The small electrodes (42 cm2) are intended for children with a body weight under
25 kg.

Adult electrodes The adult electrodes with the blue connector are used for adults and children from
25 kg.

The adult electrode can be used for children when the patient type is set to Child.
Refer to section 5.1.3 Defibrillating children/neonates.
Art. no: 0-48-0366 Rev: g

Paediatric electrodes  The paediatric electrodes with the yellow connector are used for children
weighing less than 25 kg. The energy setting is automatically reduced (default 50
joules) with the paediatric electrodes. The default can be set in the device’s
configuration; refer to section 11.6.2 Defibrillator

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5 Defibrillation
5.5 Defibrillation using Pads DEFIGARD HD-7

5.5.2 Applying the electrodes

 Good contact between the skin and the adhesive electrodes must be checked.
Suntan oil, sand or salt reduce the adhesive quality.
 The applied pads must have good contact with the patient's skin, and air bubbles
under the pads must be avoided. To do so, stick on one end of the pad, then
smooth it out to the other end.

Adults and children from 25 kg

Electrode placement is the same for adults and for children weighing 25 kg or more
(refer to Fig. 5.3 Adult and children weighing 25 kg or more electrode application
sites.

 The safety distance between the two electrodes should be approximately 3 cm.

1. Clean and dry the application points for the electrodes (refer to Fig. 5.3 Adult and
children weighing 25 kg or more electrode application sites). Only clean the skin
by gently rubbing it with a dry cloth. Shave the skin if required.
2. Apply one electrode above the right nipple. Do not apply it on the clavicle (une-
ven).
3. Apply the other electrode slantwise below the left breast as illustrated in Fig. 5.3
Adult and children weighing 25 kg or more electrode application sites).
4. Make sure that the connections are positioned on the outside so that the cables
do not hinder CPR.
Fig. 5.3 Adult and children weighing 25 kg
or more electrode application
sites

Children weighing less than 25 kg

The energy setting is automatically reduced with the Paediatric electrodes.

1. Clean and dry the application points for the electrodes (refer to Fig. 5.4 Applica-
tion sites for children less than 25 kg). Only clean the skin by gently rubbing it with
a dry cloth. Shave the skin if required.
2. Apply one electrode above the right nipple as illustrated in Fig. 5.4 Application
sites for children less than 25 kg.
3. Apply the other electrode slantwise below the left breast as illustrated in Fig. 5.4
Application sites for children less than 25 kg.
Check that the connections are positioned on the outside so that the cables do not
hinder CPR.

Fig. 5.4 Application sites for children less

than 25 kg
Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Defibrillation using Pads 5.5

5.5.3 Connecting pads to the device

1. Connect the pad connector (2). Disconnect Paddles (1) first, if necessary.
2. If the device starts in Monitor or AED mode, proceed according to the description
in chapter 5.2.1 Activating the manual defibrillation mode, page 81.

5.5.4 Checking the electrodes

If the resistance between the skin and the electrodes is too high, the message

CONNECT THE ELECTRODES (AED mode) or (Manual mode) is issued.

BAD

Proceed as follows:
1. Press the electrodes/pads down firmly and check if the message disappears.
Carefully press the pad onto the patient's skin again. If the message does not dis-
appear, continue to 2.
2. Remove both defibrillation electrodes
3. Wipe the rest of the contact agent off with a cloth.
4. Shave both application areas again
5. Apply new defibrillation pads to these points.
Art. no: 0-48-0366 Rev: g

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5 Defibrillation
5.6 Synchronised Defibrillation DEFIGARD HD-7

5.6 Synchronised Defibrillation

5.6.1 Warning erroneous triggering

 Erroneous triggering, interpretation hazard

– For synchronised defibrillation, the ECG electrodes should be applied as far
from the defibrillation electrodes as possible (for example, on the limbs).
– Use only silver/silver-chloride electrodes if you acquire the ECG via separate
ECG electrodes. These electrodes prevent polarisation voltages, which may be
caused by the defibrillation shock, resulting in an ECG trace on the monitor
screen or recording that simulates cardiac arrest.
 Disturbed ECG trigger signal. Signal noise may disturb the ECG signal and
Green QRS trigger mark cause artefacts. This must be considered in the synchronised mode and in
demand pacing. For this reason, the following should be observed:
– Do not touch the device during defibrillation to prevent electrostatic noise
– Keep the patient cable away from the power cord transformer.
 To achieve adequate ECG signal quality for reliable triggering, check that:
– The ECG signal is free of artefact
– There are no major fluctuations in amplitude
– The displayed green QRS trigger marks are positioned exactly above the R-
wave.

5.6.2 Setup switching from synchronised to asynchronised mode

The synchronised mode (1) is manually activated (Sync). Depending on the factory
setup, the synchronised mode stays activated after delivering the shock (Sync after
sync shock =Yes) or switches back to asynchronised shock (Sync after sync shock =
No). The current setting must be communicated to the user.

1  The default setting is Sync after sync shock = No:

 The manually activated synchronised mode is deactivated after delivering a
synchronised shock. To deliver a second synchronised shock, it is important to
activate it again.
 If the setting is Sync after sync shock = YES:
Charge  The manually activated synchronised mode is maintained after delivering a
synchronised shock. To deliver asynchronised shock, it is important to select
CPR Guide Event Print
aSync again.

Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Synchronised Defibrillation 5.6

5.6.3 Function of the synchronised defibrillation procedure

For synchronised defibrillation, the defibrillation shock is delivered in synchronisation

with the heart action, as the heart is still working. As a prerequisite, the patient's ECG
signal must be supplied to the defibrillator. The user can select his preferred ECG
synchronisation source from among ECG I, ECG II, ECG III or DEFI signals. After the
1
physician has triggered the defibrillation shock, the trigger signal for the actual shock
delivery is derived from the subsequent R wave (maximum 60 ms after the green
trigger mark (R-wave) on the monitor screen (1).

Pulse-triggering Shock release

CPR Event Print

Fig. 5.5 Synchronised defibrillation

Keep the shock button pressed

 Be aware that after initiation of the shock, the actual shock is released with the
next trigger signal (QRS) derived from the ECG. This may lead to a shock
delivery delay time of several seconds.
 The activated synchronised mode is switched OFF automatically if no
synchronisation on a QRS can be performed within 6 seconds.
Art. no: 0-48-0366 Rev: g

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5 Defibrillation
5.6 Synchronised Defibrillation DEFIGARD HD-7

5.6.4 Synchronised defibrillation procedure

1. Connect the electrode cable to the pad connector (refer to section 5.5.1 Adult and
paediatric electrodes
2. If the device starts in Monitor or AED mode, proceed according to the description
in 5.2.1 Activating the manual defibrillation mode.

3. Select synchronised Sync defibrillation via the touch screen (1).

Note that there is a safety timer here. If the charge is not activated within 5 sec-
onds and the ECG signal cannot be interpreted by the device, the system auto-
1 matically switches back to asynchronous defibrillation.
4. Check ECG rhythm:
– The QRS beep sounds
– The trigger pulses are shown above the R-wave
5. Select the desired energy with the + and - buttons.
Charge 6. Charge the desired energy with the Charge button.
As soon the defibrillator is ready to deliver a shock, an audio signal sounds, and
Metronome CPR Guide Print
the LED below the shock button is turned on.
 You now have 20 seconds to work through points 8 to 10 before the internal safety
discharge is activated due to exceeding the time limit.
7. Check the ECG curve, Sync (1) selected and energy setting.
Fig. 5.6 Switching to synchronised defi-
brillation

 Danger of electric shock

Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.

8. Deliver the shock by pressing the button on the keyboard

 Keep the button pressed until the shock is delivered.

 Be aware that after initiation of the shock, the actual shock is released with the
next trigger signal (QRS) derived from the ECG. This may lead to a shock
delivery delay time of several seconds.
9. After the shock is delivered, monitor the patient and the ECG signal.

 If the default setting is Sync after sync shock = No the synchronised defibrillation
mode is switched back to aSync after delivering the shock.

10. If a second attempt is contemplated, return to step 4.

If an asynchronised shock is required while in synchronised mode, it is possible at any

time to switch the synchronised mode to aSync and deliver the shock immediately
Art. no: 0-48-0366 Rev: g

asynchronised.

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 Defibrillation 5
DEFIGARD HD-7 User guide Semi-automated Defibrillation (AED) 5.7

5.7 Semi-automated Defibrillation (AED)

 Delivering a shock to a patient with a normal heart rhythm may induce VF. For
this reason, first read the general rules and safety information in section
5.1 Application Guidelines and Safety Notes
 Electric shock hazard. Turn OFF the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an
internal safety discharge.
 According to AHA/ERC guidelines, children under 8 years old may be
defibrillated in semi-automated mode even without energy reduction if no other
means are available.
 In the semi-automated mode, the electrodes should be applied in the common
anterior-anterior positions. With infants, anterior-posterior placement can be
advised to prevent a short circuit between the two defibrillation electrodes.
 If, in the course of treatment, a patient spontaneously regains consciousness, a
defibrillation shock that may have been advised just before must not be
delivered.
 During HF surgical interventions, ECG analysis is not permitted in the semi-
automated mode.

5.7.1 Semi-automated defibrillation procedure

• The switched OFF device can be started directly in AED mode by selecting the
AED mode.

When the AED mode starts, the spoken and visual instructions for the defibrillation are
Pause
issued, and the analyses run automatically as soon as the pads are applied. Closely
follow the instructions.

To minimise the hands-off time, the high-voltage capacitor is always charged during
the AED analysis. Therefore, when a shock is recommended, the energy is already
ready to be delivered.

CPR Events Screenshoots Print Analyse Menu

Art. no: 0-48-0366 Rev: g

For qualified physicians only

The analysis can be repeated at any time during CPR by pressing the analysis button.

Analyse CPR must be interrupted while the analysis is performed.

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5 Defibrillation
5.7 Semi-automated Defibrillation (AED) DEFIGARD HD-7

5.7.2 Voice messages in AED mode

 The following feature may disturb users; therefore, it is only to be used after
proper user information.
– The setup Anteriority Analyse feature pre-analyses the heart rhythm before
the actual analysis. This feature can substantially reduce the duration of the
analysis, but the sequencing of AED instructions might be very fast.

The following instructions are spoken by the device:

Spoken instructions Display Note

Illustration for electrode
connection
Technical alarm:
Electrodes have not yet been applied. The
Plug and apply electrodes message disappears as soon as the electrodes
PLUG AND are correctly applied and the resistance is
APPLY ELECTRODES between 25 to 250 Ohms.

DO NOT TOUCH THE PATIENT

Do not touch the patient. Analysing ANALYSING

MOVEMENT DETECTED - Technical alarm: The patient was moved during

Movement detected - Analysis
ANALYSIS CANCELLED, analysis, and the device could not run an
cancelled, resume CPR RESUME CPR analysis.
Device recommends a shock
SHOCK ADVISED DO NOT
Shock advised TOUCH THE PATIENT

Stand clear of patient; press orange PRESS ORANGE BUTTON

button TO SHOCK

Device does not recommend a shock

No shock advised NO SHOCK ADVISED.

Immediately resume CPR: 30 chest 30a CHEST COMPRESSION

compressions, then 2 rescue breaths – THEN 2 RESCUE BREATHS
continue until the patient is breathing
normally.
a. When paediatric electrodes are used, CPR is carried out in the ratio of 15:2 if 2 rescuers are on the spot; otherwise, 30:2. A continuous compressions option is also
available (that is, no rescue breaths) Art. no: 0-48-0366 Rev: g

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 Defibrillation 5
DEFIGARD HD-7 User guide Semi-automated Defibrillation (AED) 5.7

5.7.3 Defibrillation procedure

When the device is switched on, spoken and displayed instructions are issued
regarding the defibrillation. Closely follow the instructions.

Step 1 Switching ON and preparing the device

1. Switch the device ON by selecting the AED mode.
2. Check the state of the patient.
3. Connect the electrode cable to the pad connector.
4. You are prompted to continue the resuscitation and to apply the electrodes.
5. Apply the defibrillation electrodes (refer to section 5.5.1 Adult and paediatric elec-
trodes)
The message CONNECT THE ELECTRODES is switched OFF as soon as the
device measures an acceptable electrode resistance. If it is not switched OFF, re-
fer to section 5.5.1 Adult and paediatric electrodes.
Fig. 5.7 Switch unit ON

Step 2 Analysis
6. The analysis starts automatically when the electrodes are detected.
7. You are prompted not to touch the patient any more.
Analyse 8. The analysis key can be pressed at any time during CPR to start a new analysis.

If the device detects VF or VT with a HR exceeding 150 pulse/minute, Step 3 Shock

delivery follows; otherwise continue with Step 4, CPR.
Fig. 5.8 Analysis

Step 3 Step 3 Shock delivery

As soon as the energy for a shock is charged, the device prompts the user to deliver
the shock by pressing button 3.

 Danger of electric shock

Do not, under any circumstances, touch the patient during shock delivery.
 Make sure that the patient does not touch any conducting objects.

9. Deliver the shock by pressing the button on the keyboard

Art. no: 0-48-0366 Rev: g

10. After the shock delivery, step 4 follows.

The following default energy values are programmed:

Shock Adults Children

1 150 joules 50 joules
2 200 joules 50 joules
3 200 joules 50 joules

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5 Defibrillation
5.8 CPR DEFIGARD HD-7

Step 4 CPR
11. Carry out CPR. Alternate between 30 chest compressions and 2 breaths1 for
2 minutes2. After 2 minutes, the device begins again with Step 2, Analysis.
12. Finish the therapy (refer to Chapter 7 Finishing the Therapy).

The CPR duration may vary according to country-specific standards (refer to section
9.1.1 Device settings menu Defibrillator ERC Protocol).

To minimise the hands-off time, the high-voltage capacitor is always charged during
the AED analysis. Therefore, when a shock is recommended, the energy is ready to
be delivered.

5.8 CPR
 If the victim is installed on a mattress, the Chest Compression may be
cushioned, leading to a loss in CPR quality. Consider moving the victim on a
hard surface for optimal CPR quality.
 Performing Chest compression can lead to thorax injuries.

The manual and AED defibrillation mode offers two functions for guided CPR:
CPR
• CPR Guide
• Metronome
CPR OFF The CPR Guide behaviour is different depending on the active CPR Feedback feature
METRONOME of your device (SCHILLER LifePoint or FreeCPR)

5.8.1 SCHILLER LifePoint

The LifePoint measures the compression depth, rate and recoil3 after each
compression, except in France, Germany, the UK and the USA.

 The ARGUS LifePoint should not be used if any other technique, as

compression of the chest with the help of the heel of the hand, is used.

• The range for the depth of compressions is 4.5 to 6.2 cm, which is the range for
Art. no: 0-48-0366 Rev: g

adult patients. There is no recommended target depth for paediatric patients < 8
years or < 25 kg.
• We recommend using an adhesive pad so that the sensor remains in position and
does not lift off when relieved, which can lead to inaccurate measured values.
• The red side of the sensor must be attached to the adhesive pad.

1. A continuous compression option is also available (that is, no rescue breaths)

2. CPR cycle duration can vary depending on the CPR cycle configuration settings.
3. This feature is not available in France, Germany, the UK and the USA.

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 Defibrillation 5
DEFIGARD HD-7 User guide CPR 5.8

COMPRESSION
FREQ: Measured value from
LifePoint sensor
DEPTH

RECOIL1 good
MESSAGE
30 CHEST COMPRESSIONS
THEN 2 RESCUE BREATH Advice to improve the
PRESS FASTER CPR quality

CPR Event Screenshot Manual def Analyse Close

Setup of the Sensor

1. Connect the LifePoint USB cable to the adapter cable.

2. Switch the device ON, then select Manual or AED defibrillation.
3. Open the CPR menu and activate the CPR guide.

4. Place the LifePoint on the patient’s chest and start CPR.

5. Place your hand on the sensor so that the heel of your hand is in the middle of
the sensor (1).

1
Art. no: 0-48-0366 Rev: g

6. Start with CPR, monitor the compression quality on the device and follow the in-
structions given by the device (refer to the previous page).
7. The displayed measurements on the right side of the screen inform you about
your CPR quality.

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5 Defibrillation
5.9 Defibrillator Technical Messages DEFIGARD HD-7

8. The following limits are set for speed and depth:

Metronome speed [/min] Press Faster Press Slower

100  90 120
110 100 130
120 110 140

Depth [mm] Press Deeper Press Shallower

1 to 127 45 62

5.8.2 FreeCPR
The FreeCPR measures the compression rate based on the impedance
measurement by the defibrillation electrodes.

1. Switch the device ON, then select Manual or AED defibrillation.

CPR 2. Apply the defibrillation electrodes.
3. Open the CPR menu and activate the CPR guide.
4. The displayed measurements on the right side of the screen inform you about the
CPR OFF
CPR quality and frequency.
METRONOME
ON

CPR GUIDE

5.8.3 Metronome settings

1. Open the CPR menu.

CPR 2. Activate the metronome.
3. The following settings are available:
CPR – 30:2
ON
– 15:2
METRONOME
– Continuous

Continuous
OFF

CPR GUIDE

In case of difficulty delivering chest compressions at the recommended rate, follow

the pace provided by the metronome.
Art. no: 0-48-0366 Rev: g

5.9 Defibrillator Technical Messages

Alarm Code Cause Remedy
• Poor impedance can be caused by:  Check the contact between elec-
– Defective electrodes trode and the patient
T.DEFI01  Reapply new electrodes
Check the cable – No or bad applied electrodes
– Electrodes cable not connected
• CPU peripheral board defective  Replace the device

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 Defibrillation 5
DEFIGARD HD-7 User guide Defibrillator Technical Messages 5.9

Alarm Code Cause Remedy

Module inoperative T.DEFI18 • Defective stim board  Replace the device

T.DEFI19  Replace the device

Module error • Defective defi board
T.DEFI20

Incompatible waveform • Incompatibility between software  Replace the device

T.DEFI20
type and hardware
Art. no: 0-48-0366 Rev: g

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6 Pacemaker
6.1 Pacemaker Function DEFIGARD HD-7

6 Pacemaker
6.1 Pacemaker Function
The pacemaker is the module for external transcutaneous stimulation of the heart.

The DEFIGARD HD-7 pacemaker function is delivering electric stimulation pulses in

order to generate myocardial contractions. It may be used as a bridge to an alternative
treatment like transvenous pacing or permanent pacing.

Intended users

ACLS: Qualified medical personnel trained for ACLS and trained in the use of the
DEFIGARD HD-7 may use the external pacemaker operating mode of the
DEFIGARD HD-7.

Medical indications: The DEFIGARD HD-7 pacemaker function can be used for the
treatment of patients who present symptomatic or hemodynamically unstable
bradyarrhythmia.

• Limitations: This treatment might need other supportive measures. Pacing

thresholds tend to be higher in patients with emphysema or pericardial effusion
and in those who receive positive pressure ventilation because of increased chest
cavity impedance from air or fluids.
• Contraindications for the patient: This treatment is not indicated for patients
presenting VF or asystole.
• Side effects: Pacing at higher currents can lead to significant discomfort and
pectoral muscle twitching.
The pacemaker offers two modes of operation: demand and fixed mode, i.e. fixed-rate
pacing. In demand mode, the pacemaker requires an ECG signal for synchronisation.

The same large adhesive electrodes used for defibrillation are also employed for
pacing. They provide good electrical contact with the skin. These electrodes and a 20
ms square-wave pulse reduce painful muscle contractions provoked by excessive
current density.

Pacer rate, pulse width and current are checked when the device is turned on and
during operation; therefore, a functional test of the pacemaker module is not
necessary.

6.1.1 Fixed-rate mode (Fix)

In this operating mode, the module delivers pacing impulses with the user-defined
Art. no: 0-48-0366 Rev: g

current at a user-defined rate. The selected rate remains constant and is not affected
by intrinsic actions of the patient's heart. This mode is mainly used in the case of
asystoles.

Monitoring the patient’s ECG with a 4-lead ECG cable is recommended to ensure
continuous ECG monitoring when using the fixed mode.

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 Pacemaker 6
DEFIGARD HD-7 User guide Safety Notes 6.2

6.1.2 Demand mode

In demand mode, the pacemaker does not deliver pacing pulses as long as the
patient's intrinsic HR exceeds the set pacing rate. When the HR drops below the
pacing rate, the pacemaker starts emitting stimulation pulses. This can only be
ensured by continued monitoring of the ECG with a 4-lead patient cable. The
pacemaker reads the necessary ECG signal via the ECG cable. If the module is not
able to reliably identify QRS complexes, it stimulates the heart permanently in
demand mode.

The demand mode is the recommended pacing mode when the patient is at risk of
developing bradycardia or even asystole as a result of a critical event. As the patient's
ECG controls the pacemaker function, the harmful competition between intrinsic and
external stimulation, which could induce VF, is excluded.

6.2 Safety Notes

 Shock hazard
Never touch the pads or the patient's body near the pads while the pacemaker
is in use.

 Patient hazard, equipment failure

Equipment delivering electrical energy to the patient at the same time as the
pacemaker can disturb the pacemaker’s function. Particularly, HF surgery
equipment used on a pacemaker patient may cause interference, preventing the
detection of QRS complexes. In this situation, the pacemaker must be set to
fixed mode, i.e. fixed-rate pacing. Note that leakage currents could be
transferred to other electric circuits, interfering with the functioning of devices
connected to these circuits.
 For safety reasons, the external pacemaker should be disconnected from the
patient in this situation, and an internal pacemaker should be used.
 Accessories, wearing parts and disposables that affect the safe use of the
pacemaker and that are to be used in conjunction with the pacemaker must be
tested for safety and approved by an authorised test laboratory.
 Pacing is not possible with paddles.

6.3 Guidelines for the Application of External

Pacemakers
These guidelines apply to all pacemakers, irrespective of type and manufacturer.

All electrical devices that deliver energy to patients in any form or have an electrically
Art. no: 0-48-0366 Rev: g

conductive connection to the patient are a potential source of danger. As the user is
responsible for the safe application of the devices, observing the instructions in the
user manual and the guidelines below is very important.

 Pacemakers must only be used under the supervision of trained, qualified and
authorised staff.
 Conscious patients need to be sedated before pacing to reduce patient
discomfort.
 On neonates, a particular follow-up of the pacing procedure needs to be done to
avoid severe burns. The skin under the paediatric electrodes needs to be
checked regularly to detect erythema early on.
 Observe the user guide for the pacemaker's operation.

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6 Pacemaker
6.3 Guidelines for the Application of External Pacemakers DEFIGARD HD-7

 The patient must not be left unattended during pacing.

 It is assumed that the patient's ECG and plethysmogram are being monitored to
be able to assess the effect of pacing.
 When positioning the patient, take care that no electrically conductive
connections exist between the patient and earthed metal parts (puddles of
water, for instance, are capable of conducting the electrical current). Although
the pacer current output is required to be floating, this is an additional safety
precaution to ensure that the pacemaker current pulse flows only between the
pacemaker electrodes.
 Set all values for the pacemaker to position 0, or the lowest value.
 Position stationary pacemakers close to the patient.
 After each defibrillation, check that the pacemaker is functioning properly.
 Transcutaneous pacing can be applied to sensitive myocardial substrate
patients (hypothermic) under careful monitoring conditions.

6.3.1 Attaching the pacer pads

• The same adhesive electrodes used for defibrillation are also employed for pacing.
The electrodes are designed for:

Adult pads
• 1 hour of pacing using 140 mA/120 p/minute (pulse duration 20 ms)
• 8 hours of pacing using 70 mA/60 p/minute (pulse duration 20 ms) with inspection
of pads every 30 minutes
Paediatric pads
• For up to 1 hour of pacing using 70 mA/140 p/minute (pulse duration 20 ms) with
inspection of pads every 30 minutes

A detailed application of electrodes is given in section 5.5.1 Adult and paediatric

electrodes.

Anterior-posterior placement

1. Apply the dorsal electrode + to the left scapular area, the precordial electrode -
near the left lower sternal edge.
2. Connect the pads to the device.
If the dorsal electrode cannot be used, apply anterior-anterior placement.

Fig. 6.1 Anterior-posterior placement

Anterior-anterior placement
Art. no: 0-48-0366 Rev: g

1. Apply the + electrode on the right side below the clavicle and the - electrode to
the left of the axillary line on a level with the 5th intercostal space so they do not
hinder heart massage.
2. Connect the pads to the device.

Fig. 6.2 Anterior-anterior placement

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 Pacemaker 6
DEFIGARD HD-7 User guide Start-up of the Pacemaker 6.4

6.3.2 Checking the electrodes

If the resistance between the skin and the electrodes is too high, the message

CONNECT THE ELECTRODES is issued.

BAD
Proceed as follows:

1. Press the electrodes/pads down firmly and check if the message disappears.
Carefully press that pad onto the patient's skin again. If the message does not
disappear, continue to 2.
2. Remove both defibrillation electrodes.
3. Wipe the rest of the contact agent off with a cloth
4. Shave both application areas again
5. Apply new defibrillation pads to these points.

6.4 Start-up of the Pacemaker

 Shock hazard
Pacing is immediately started when the pacemaker is switched ON, and the
current is set.

In order to be able to operate the pacemaker, the following conditions must be met:

• The pacemaker (optional) needs to be activated.

• Pads must be connected to the device.
• When the pacemaker is switched ON, the current value is set to 10 mA.
• The device can be switched from pacing to defibrillation mode at any time. The
pacemaker is stopped.

6.4.1 Pacemaker display

 Select the Pacer mode.

The pacemaker menu with the pacemaker parameter is displayed.

The pacemaker default mode at switchover is demand mode; fixed mode has to be
selected manually.
Art. no: 0-48-0366 Rev: g

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6 Pacemaker
6.4 Start-up of the Pacemaker DEFIGARD HD-7

6.4.2 Selecting pacemaker mode

Impedance OK/ Time indication of the duration of the
High/Low stimulation
Frequency and White mark = pacer pulse from
Time since the pacer mode
Current setting the device
was activated

Off
HR

Type of used NIBP

electrodes
OK Pacer
Frequency
Fix NIBP History
Current
Demand

Event Screenshot Print Start Menu

Start pacing Pause pacing

Flash shows the current
delivered stimulation impulse

Art. no: 0-48-0366 Rev: g

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 Pacemaker 6
DEFIGARD HD-7 User guide Start-up of the Pacemaker 6.4

6.4.3 Pacemaker settings operational Fixed mode

Monitoring the patient’s ECG with a 4-lead ECG cable is recommended to ensure
continuous ECG monitoring when using the fixed mode. The user can select his
preferred HR source among ECG I, ECG II, ECG III and Defi.

1. Attach the pacer pads and ECG cable (refer to section 6.3.1 Attaching the pacer
pads).
2. Display the pacemaker and select operational mode Fix.
3. Select (1) Frequency + or - to set the impulse frequency.

Frequency
Fixed
Current
Demand

3 2

Pause pacing

 Shock hazard
Pacing is immediately started when the pacemaker is switched ON, and the
current is set.
 Never touch the pads or the patient's body near the pads while the pacemaker
is in use.

4. Press the Pacer Start (2) to activate the pacemaker.

5. Press the (3) Current + or - mA buttons to set the impulse current until the heart
reacts to the stimulation.
Art. no: 0-48-0366 Rev: g

6. The pacemaker can be interrupted and restarted by selecting the Pacer Pause.
7. Finish the therapy as described in Chapter 7 Finishing the Therapy.

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6 Pacemaker
6.4 Start-up of the Pacemaker DEFIGARD HD-7

6.4.4 Demand mode

To determine when a pacemaker pulse is required, the patient’s ECG must be

monitored with a 4-lead ECG cable (refer to the reminder image below). The user can
select his preferred HR source among ECG I, ECG II or ECG III.

1. Attach the pacer pads and ECG cable; refer to 6.3.1 Attaching the pacer pads.
2. Display the pacemaker and select operational mode Demand.
3. Select (1) Frequency + or - to set the impulse frequency.

Off

HR

NIBP
Reminder:
OK Pacer
Frequency  Attach a 4-lead ECG
Fixed NIBP History cable to the patient and
the device.
Current
Demand

Event Screenshot Print Start Menu

2
3 4

 Shock hazard
Pacing is immediately started when the pacemaker is switched ON, and the
current is set.
 Never touch the pads or the patient's body near the pads while the pacemaker
is in use.
Art. no: 0-48-0366 Rev: g

4. Press the Pacer Start (2) to activate the pacemaker.

5. Press the (3) Current + or - mA buttons to set the impulse current until the heart
reacts to the stimulation.
6. The pacemaker can be interrupted and restarted by selecting the Pacer Pause.
7. Finish the therapy as described in Chapter 7 Finishing the Therapy.

If required, the device can be switched into the defibrillation mode at any time using
the rotary switch.

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 Finishing the Therapy 7
DEFIGARD HD-7 User guide Start-up of the Pacemaker 6.4

7 Finishing the Therapy

1. Switch the device OFF as soon as the therapy is finished.
2. Disconnect the electrode cable.
3. Depending on the type of electrodes you are using:

Adhesive electrodes – Carefully remove the electrodes from the patient's skin.

– Discard the disposable pads immediately after use to prevent their reuse (hos-
pital waste).

Paddles Clean the paddles immediately after use (refer to section 10.6.2 Cleaning and
disinfecting the device, cable and sensors).

Device, ECG cable, adapter cable Clean the device, ECG cables, adapter cable and sensors as described in section
and sensors 10.6.2 Cleaning and disinfecting the device, cable and sensors).

Spoons and cable Clean the spoons and connection cable immediately after use (refer to section
10.6.3 Spoon electrodes and cable cleaning/disinfection/sterilisation).
Art. no: 0-48-0366 Rev: g

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8 Data Management
8.1 Intervention data DEFIGARD HD-7

8 Data Management
The device can store up to 24 hours of data, where each intervention is a maximum
of 4 hours long. Data is stored on the device in a non-volatile memory. Therefore, data
is not lost after a POWER OFF.

8.1 Intervention data

In order to document the intervention, the intervention data is saved.

The current intervention data can be reviewed or printed from the main menu (trend
data, Long ECG, screenshots); refer to 4.10 View Trends, Events and Screenshots.

Data from closed interventions can be reviewed or transmitted by accessing the

memory in the Test operating mode; refer to section 8.1.2 Review, print and transmit
intervention data.

The intervention report can either be printed or used to generate an A4 PDF by

accessing the memory in the Test operating mode.

• If the memory is full, the oldest data is overwritten. This is indicated by the
message Memory full.
• The data is stored until the data has been transmitted via the menu “Test-Setting
> Transmission clear memory”.

Overview of events documented with date and time in the intervention file:

• Full disclosure ECG II curve (if ECG cable is used)

• Full disclosure ECG DEFI curve (if pads or paddles are used)
• Full disclosure curve (impedance variation through defibrillation pads/paddles)
• CPR Feedback events
• Long ECGs
• Screenshots
• Events (manual and automatic) with their timestamp
• Patient vitals
• Patient information
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 Data Management 8
DEFIGARD HD-7 User guide Intervention data 8.1

8.1.1 Start and stop intervention

• The intervention data is stored as soon the device is switched OFF or the
intervention has been stopped with the function Stop Intervention in the main
Menu menu.
• Stop Intervention is also used to start a new intervention.
• The data is stored until the data has been transmitted via the menu Post-
Intervention.
All intervention data (Long ECG, Screenshots and Trends) can be reviewed and
transmitted on the device by accessing the memory in the Test operating mode; refer
to section 8.1.2 Review, print and transmit intervention data.

8.1.2 Review, print and transmit intervention data

Intervention data transmission via several communication channels is possible, for
example, via Wi-Fi, USB-Ethernet, to a USB stick or to a printer.

• The transmitting channel can be defined after selection

• USB export shall only be used if network communication is not possible
(Cybersecurity guidelines)
• It is recommended to securely erase the USB stick after use.

• Access the menu Test Settings, Transmission clear memory is then available.
 To exit Test mode, select the Off position, then wait until the device switches off.
Now select one of the three operation modes.
Review and print intervention from memory
1. Select Memory; the intervention list is displayed.
2. Select the desired intervention file.
3. For each intervention, you can review, print or send the following data.

Test Settings
Data Review Print Send (Email or USB)
Start self-test Long ECG X X
Art. no: 0-48-0366 Rev: g

Screenshot X X X
Review/Send self-test result
Trends X X -
Transmission/Clear memory
Review events X X -
Memory
Intervention report - X X
Control panel

4. Select one of the available functions:

– Print
– USB stick
– Email

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8 Data Management
8.1 Intervention data DEFIGARD HD-7

Transmission and Clear memory

This transmits all intervention files and clears the whole memory in the intervention
memory of the device.

1. Select transmission/Clear memory

2. Confirm Yes, Transmit and clear memory
3. Select Network or USB storage
4. The Transmission List is displayed, and the Send in Progress icon is displayed
until the transmission is finished
5. An empty transmission list is displayed.

8.1.3 Selecting communication media

To change the transmission media, select the transmission icon Wi-Fi or USB and
select the menu Communication media. Select, and the Corresponding icon is
Search for displayed on the top right status bar.
Network

No connection to the
WLAN transmission
channel. Transmission to
USB stick only.

Art. no: 0-48-0366 Rev: g

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 Data Management 8
DEFIGARD HD-7 User guide Patient Data Information 8.2

8.2 Patient Data Information

8.2.1 Patient Data Query (PDQ) (Optional)
When the unit is connected to SEMA or another hospital patient database (via
network or WLAN), patient data can be filled in automatically when the Patient ID or
Visit ID is entered. This is called Patient Data Query or PDQ.

Patient data query is possible as follows:

– PDQ in the worklist

The patient data is filled in automatically after the Pat ID/visit ID has been entered by
the user (confirm by pressing Enter) (see following).

The PDQ settings are defined in Menu > Settings > General > Workflow, the following
options are available:

• PDQ mode - select one of the following: – Patient ID – Visit ID These settings along
with other transmission settings are detailed in the system settings.

8.2.2 PDQ in Worklist (Optional)

If you use the "Worklist" workflow, you can search/enter patient data in the same way.
Tap the Search field and read the Patient ID or Visit ID using the barcode reader. The
corresponding work item is shown in the worklist.

8.3 Technical Data

8.3.1 Self-test review and transmitting
• Access the menu Test Setting, then select Start self-test or Review/Send self-
Test Settings test.
 To exit Test mode, select the Off position, then wait until the device switches off.
Start self-test Select one of the three operation modes.
Review/Send self-test result Review, Print or transmit Self-test results from memory
A self-test can be executed after a finalised intervention to check the performance of
Transmission/Clear memory
the device. Additionally, the self-test report can be reviewed by printing on the thermal
Memory printer or sent via Network or directly to a USB stick.

Control panel 1. Select Review/Send self-test. A list of self-tests is displayed.

 To review, select the desired file and scroll through the tests.
 To Print or transmit, tick the checkbox of the desired self-test file (multiple
Art. no: 0-48-0366 Rev: g

selection possible).
2. Press Next
3. Select one of the available functions:
– Print
– USB storage
– Network

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8 Data Management
8.3 Technical Data DEFIGARD HD-7

8.3.2 Logfiles

The device records every action in log files. Each log file data can contain up to
50,000 lines. A circular buffer overwrites the oldest log file entries when the limit of 50,
000 lines is reached. Data is stored on the device in a non-volatile memory. Therefore,
data is not lost after a power off.

Art. no: 0-48-0366 Rev: g

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 Main Menu 9
DEFIGARD HD-7 User guide General Setup 9.1

9 Main Menu
9.1 General Setup
For the monitoring of vital parameters, physiological alarm thresholds are preset in the
DEFIGARD HD-7, which are activated when the device is turned on. The operator-
defined thresholds (wide/narrow) can be set in the respective menus (refer to section
4.3 Operator Defined Alarm Thresholds)

1. Press the Menu softkey. The menu is displayed.

Adult Off

HR

NIBP

Long ECG

Screenshots

Trends

ECG Event Screenshot Print Start Menu

Menu
Stop intervention

Language

Fig. 9.1 Main menu

Art. no: 0-48-0366 Rev: g

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9 Main Menu
9.1 General Setup DEFIGARD HD-7

9.1.1 Device settings menu

Access the device settings menu via the menu button.

Menu Sub-menu/Parameter Description Note

View 6-lead • Monitoring Selection of different views The selection is depending on
• 6 leads ECG according to user’s needs the configuration of the device
Long ECG • Selecting Long ECG List of the recorded long ECG
Refer to section 4.5 Long ECG
since the intervention has
Recording
started
Trends • ---- Shows the trend since the start Refer to section 4.10.1 View
of the intervention trends
Review events • ---- Shows the events since the
-
start of the intervention
Screenshots • Selecting Screenshot List of the screenshots done
since the start of the
Refer to section 4.10.3 View
intervention. The screenshot
and print events
can be displayed, transmitted
or printed.
Stop Intervention • Yes/No The stopped intervention can
Yes stops the recording of all
be reviewed/transmitted in the
data, saves data under the
Post-intervention menu. The
intervention file and resets the
number under the Stop
Stop-watch on the screen to
Intervention parameter shows
zero. A new intervention is
the Intervention ID with date
started.
and time.
• List of available languages The language setting here is
Select the desired language for only for the current use. Once
Language the current use. the device is switched OFF, it
uses the default configuration.

9.1.2 Test setting menu

Access the Test Settings menu via the Test position.

 To exit Test mode, select the Off position, then wait until the device switches off.
Select one of the three operation modes.

Menu Sub-menu/Parameter Description Note

Art. no: 0-48-0366 Rev: g

Running a self-test to confirm

Start Self-test - the functionality after finishing
an intervention.
- Review or transmitting self- Refer to section 8.3.1 Self-test
Review/Send Self-test
tests review and transmitting
Refer to section 8.1.2 Review,
Transmission/Clear Transmission/Clears memory
- print and transmit intervention
memory of all intervention files.
data

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 Main Menu 9
DEFIGARD HD-7 User guide General Setup 9.1

Menu Sub-menu/Parameter Description Note

- Memory of all intervention files
Refer to section 8.1.2 Review,
since the last clearing. The files
Memory print and transmit intervention
can be reviewed, printed or
data
transmitted via this menu.
• Device Name Entering the device name Exiting the Control panel menu
is only possible by switching
OFF the device.
• Import/export configuration
– Import from USB Exiting the Control panel menu
– Import configuration from is only possible by switching
SEMA OFF the device.
– Export to USB
• Software update
– Update from USB Exiting the Control panel menu
– Search on server is only possible by switching
– Current version informa- OFF the device.
Control panel tion
• Maintenance Once the safety cell has been
Exiting the Control panel menu
This menu is password – Safety cell replaced changed, press this button.
is only possible by switching
protected, and the default – RFID Flasher OFF the device.
password is 0000. – RFID Tag info
The responsible – Export log to USB Note that after formatting the
organisation (for – Format log file memory a self-test should be
example, a qualified – Format memory (see note) performed; refer to section
technician) must change – Start Self-test 10.2.4 Self-test
this password to prevent Manual start of the Self-test
access by unauthorised • Ethernet configuration. If set to OFF:
persons) IP address
– DHCP ON/OFF
Netmask
Gateway
DNS1-3 Server
– Radius ON/OFF If DHCP is set to ON
• Check connectivities Select one of the desired
communication channels Wi-Fi
for checking.

– Check SEMA  Activates the connectivity

connectivities check for SEMA
– Check SUS connectivities  Activates the connectivity
check for SUS
Print test Page • - - -
• Download the configuration
Update configuration from the SUS. The line below
from SEMA the parameter shows the
Art. no: 0-48-0366 Rev: g

current configuration file name.

• Download the software from
Update software from the SUS. The line below the
SEMA parameter shows the current
software.
Clock sync from SEAM •

Check connectivities •

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10 Maintenance
10.1 Maintenance Interval DEFIGARD HD-7

10 Maintenance
10.1 Maintenance Interval
The user/responsible organisation is responsible for maintaining the device (update
software/hardware) according to the maintenance interval described below. In
addition, the user/responsible organisation must update the device according to the
manufacturer’s Field Safety Notices.

Note that the unit must be serviced on a regular basis. The test results must be
recorded and compared with the values in the accompanying documents.

Maintenance work described in this chapter may be performed by a qualified

technician or by the user according to the Maintenance and Interval Table below.

The following table indicates the intervals and responsibilities of the maintenance
work required. Local regulations in your country may stipulate additional or different
inspection intervals and tests.

10.1.1 Maintenance interval table

Interval Maintenance Responsible
Life-saving functions. Check the following:
Visual inspection of the device and accessories; (refer to section
10.2.1 Visual inspection of the device and accessories)
Switch the device ON, then check that the battery is sufficiently
charged; (refer to section 10.2.2 Battery check).
Before or after each use, After every intervention:
User
respectively Visual inspection of the device and accessories; (refer to section
10.2.1 Visual inspection of the device and accessories).
Battery check; (refer to section 10.2.2 Battery check)
Defibrillator shock test; (refer to section 10.2.3 Defibrillator shock
test)
Manual test in the Test setting menu; (refer to section 10.2.4)
Functional test charging the capacitor (refer to section 10.2.4)
Monthly Manual test in the Test setting menu; (refer to section 10.2.4) User
Charge/Discharge of the capacitor 1
Measuring, safety tests and inspections according to the instructions
in the service handbook
NIBP check
ECG check Service staff authorised
Every 12 months
SpO2 check by SCHILLER
EtCO2 Gas span and leakage check
Art. no: 0-48-0366 Rev: g

Defibrillator function check

The following parts must be checked and replaced if necessary
Replace the power battery; refer to section 10.4.1 Replacing the
batteries.
Service staff authorised
Lifed item replacement Replace the internal button cell (every 10 years)
by SCHILLER
Replace the defibrillation capacitor (if the released energy [joules]
deviates more than 15% from the intended value) only DEFIGARD
HD-7
1 Only for DEFIGARD HD-7 with paddles.

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 Maintenance 10
DEFIGARD HD-7 User guide Functional Test 10.2

10.1.2 Service and shelf life

Device The device has a lifetime of 10 years.

Software Software updates are available for 10 years from the date the last device was placed
on the market.

Accessories shelf life Power battery (approximately 5 years), button cell (approximately 10 years) and
electrodes (approximately 2 years) see the expiry date on the battery or electrodes
pouch. EtCO2 accessories see the expiry date on the packaging. Defibillator spoons
maximum 50 uses.

10.2 Functional Test

A detailed description of the maintenance steps is listed in table 10.8 Inspection and
Checklist Tables. Enter the results in the checklist; refer to section 10.8 Inspection
and Checklist Tables.

10.2.1 Visual inspection of the device and accessories

Check the device and accessories for the following:

 Sufficient number of all required disposables available?

 Device housing undamaged?
 Electrode connection undamaged?
 Defibrillator/pacemaker pads available?
 Check the expiration date on the electrode package and check that the package
is not damaged
 Check the expiration date of the invasive blood pressure kit
 Defective units or damaged cables and damaged or expired accessories must
be replaced immediately.

10.2.2 Battery check

 Connect the unit to the power supply (docking Station) and switch it ON. The start
screen is displayed.
 The external DC voltage indicator is lit.

– When the battery indicator is flashing, the battery is being charged.

Check the charging status once the indicator goes OFF.

– The battery indicator is OFF when the battery is fully charged, and the full
battery symbol is displayed. The charging process can be reactivated
and checked by disconnecting it from the external DC supply and check that the
Art. no: 0-48-0366 Rev: g

indicator is flashing.
Battery status
 Click on the Battery icon and check the following status:
– Charge level
– Estimated autonomy
– Estimated numbers of shocks
– Safety Cell Voltage Level

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10 Maintenance
10.2 Functional Test DEFIGARD HD-7

10.2.3 Defibrillator shock test

1. Switch the device ON in Manual Defib (1).
2. Use the buttons + or - to set the energy level.
3. Press the Charge button, the device charges, and the Shock key lights up.
4. With the paddles, make sure that the paddles are in the paddle holders else,
make sure that a Defibrillator Shock Detector (DSD) is connected.
5. Press the Shock key on the device or the paddles.
6. Depending on the configuration, the device prints out a defibrillation report.

10.2.4 Self-test
The self-test is performed automatically by the device, either daily or weekly and can
be executed manually at any time. This test checks the most important functions of
the device. Depending on the device version, paddles or pads, there are more or less
tests that are performed.

Access the Test Settings menu via the Test position.

 To exit Test mode, select the Off position, then wait until the device switches off.
Select one of the three operation modes.
 With paddles, make sure that the paddles are in the paddle holders.

1. Switch the device ON.

2. Select the Test position, then select the menu Start self-test
3. Start the self-test.
4. If the message Press Shock button and Charge button appears, press the but-
tons to continue and finalise the test.
With paddles, press the button requested for the paddles. Previous tests are list-
ed in the sub-menu Review/send previous tests.
5. Press Back if you do not need a printout of the self-test results.

The following tests are performed depending on how the tests are initiated:

Type of Test/Interval - Dailya Every 5 weekb Manual test

Art. no: 0-48-0366 Rev: g

- Weekly
Power battery x x x

Device temperature x x x

DEFI shock relay x x x

DEFI IGBT x x x

DEFI battery x x x

Defi capacitor - x x

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 Maintenance 10
DEFIGARD HD-7 User guide Functional Test 10.2

Type of Test/Interval - Dailya Every 5 weekb Manual test

- Weekly
ECG module x x x

RFID module x x x

RFID electrodes (if enabled) x x x

NIBP module x x x

SpO2 module x x x

Communication module x x x

RCT cell x x x

Log file management - x x

Paddle dock onc - - x

Paddle dock offc - - x

Adult paddlec - - x

Adult Child paddlec - - x

Shock button device - - x

Charge button device - - x

Shock button paddles - - x

Charge button paddles - - x

Energy + button paddlesc - - x

Energy - button paddlesc - - x

Print - button paddlesc - - x

a. The automatically executed daily or weekly test depends on the configuration of the periodic test frequency; refer to section 11.6.1 General
configuration.
b. Automatically executed every 5 weeks.
c. If applicable

10.2.5 Functional test - measured value

HR  Perform the functional test according to section 4.4.3 Starting ECG monitoring
and check the HR with the measured pulse rate of the SpO2.
Art. no: 0-48-0366 Rev: g

SpO2  This test is performed on a volunteer (finger measurement; refer to section

4.6.3 SpO2 Module Masimo set.

NIBP  This test is performed on a volunteer (arm measurement; refer to section

4.7.4 Starting NIBP monitoring).
Manometer Test
Refer to the technical manual.

CO2 Sidestream Perform the functional test according to section 4.8.2 Initial operation of the ISA gas
analyser.

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10 Maintenance
10.3 Update Software DEFIGARD HD-7

10.2.6 Alarm tests

Alarm volume Check during the following tests that the alarm sound is higher than 65 dB.

HR 1. Start the ECG monitoring (refer to section 4.4.3 Starting ECG monitoring).
2. Set the alarms with the narrow quick set function (refer to section 4.3 Operator
Defined Alarm Thresholds).
3. When the measured value exceeds the alarm thresholds, an alarm is issued.
4. Reset the alarm limits to their original values.

SpO2 Refer to section 4.6 SpO2 Monitoring (Option)

NIBP 1. Start the NIBP monitoring (refer to section 4.7.4 Starting NIBP monitoring).
2. Set the NIBP alarm limits below/above the measured values and take a new
measurement.
3. When the measured value exceeds the alarm thresholds, an alarm is issued.
4. Reset the alarm limits to their original values.

CO2 1. Start the CO2 monitoring according to section 4.8.2 Initial operation of the ISA
gas analyser
2. Set the alarms with the narrow quick set function (refer to section 4.3 Operator
Defined Alarm Thresholds).
3. When the measured value exceeds the alarm thresholds, an alarm is issued.
4. Reset the alarm limits to their original values.

If the device does not behave as described in this user guide, there may be an error
that the after-sales service must repair.

10.3 Update Software

 Software updates must only be performed by authorised personnel.
 The menu is password protected.
 The software can be updated via Wi-Fi (update Server) or USB interface
(memory stick).
 The use of SUS is recommended to update device configuration.
 USB import shall only be used if network communication is not possible.
 For devices equipped with paddles, check that the paddles are properly
connected before starting the software update. Art. no: 0-48-0366 Rev: g

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 Maintenance 10
DEFIGARD HD-7 User guide Update Software 10.3

10.3.1 Access the menu control panel

1. Switch the device ON
2. Select the Test position, then select the Control Panel menu (password protect-
ed), and enter the password.
3. Select the Software update menu
4. Select Update from USB or Search on server menu.
5. Proceed according to sections 10.3.2 Update via USB or 10.3.3 Update via a
server below.

Control panel
Device name

Import/Export config

Software update
soft01.b0x.xx

Device info

Maintenance

10.3.2 Update via USB

Required accessories The USB stick must be 32 MB minimum and 32 GB maximum.

1. Connect the USB stick.

2. Switch the device ON, then check that it is connected to the mains supply or that
the battery is sufficiently charged. The device must not switch off during the up-
date.
3. Select the parameter Software update and start the update by selecting the de-
sired update source. During the update, a progress bar is displayed.
4. As soon as the update is finished, the device switches off.
5. Switch the device ON, access the menu Control Panel, then select the Device
info menu to verify that the software has been installed.

10.3.3 Update via a server

The device regularly initiates itself or a scheduled connection to the server to check
for available updates.

Requirement • Wi-Fi connection to the update server.

Update 1. Switch the device ON, then check that it is connected to the mains supply or that
the battery is charged sufficiently. The device must not switch off during the up-
Art. no: 0-48-0366 Rev: g

date.
2. Select the parameter Software update and start the update by selecting the de-
sired update source. During the update, a progress bar is displayed.
3. As soon as the update is finished, the device switches off.
4. Switch the device ON, access the Control Panel menu and then select the De-
vice info menu to verify that the software has been installed.

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10 Maintenance
10.4 Maintenance interval of the batteries DEFIGARD HD-7

10.4 Maintenance interval of the batteries

Important
• The battery's performance and life largely depend on how and under which
ambient conditions the battery is used.
Power Battery
• The rechargeable power battery is maintenance-free during its normal life.
• The battery must be replaced as follows:
– Every 3 to 5 years, or after approximately 1000 typical charge/discharge cycles.
That is, not full charge/discharge cycles.
• Only store the device with fully charged batteries. If a device is not used, recharge
it the batteries every 6 months.

10.4.1 Replacing the batteries

 A newly replaced power battery must be charged to 100% into a DEFIGARD

HD-7 before use on a patient.
 Replacing battery only by authorised personal

Replacing the power battery

• The power battery needs to be replaced if the operating time in Monitor mode is
less than 2 hours with a fully charged battery (refer to section 10.2.2 Battery check)
• Every 3 to 5 years, or after approximately 1000 typical charge/discharge cycles.

10.4.2 Putting the device in transport mode

To prevent the device from automatically waking up for the self-test, the device can
be put into transport mode with the following procedure. (only for authorised
personnel)

1. Disconnect the mains cable

2. Switch the device ON in Test mode.
3. Enter the Control Panel menu (password protected), then select the Mainte-
nance menu.
4. Activate Transport mode.
 To wake up the battery, plug in the mains cable and switch the device ON.

10.4.3 Battery disposal

 Danger of explosion. The battery may not be burned or disposed of in/with

domestic refuse.
Art. no: 0-48-0366 Rev: g

 Danger of acid burns. Do not open or heat the battery.

The battery is to be disposed of in municipally approved areas or sent back to

SCHILLER Medical.

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 Maintenance 10
DEFIGARD HD-7 User guide Cleaning 10.5

10.4.4 Residual risk with rechargeable battery

 Danger of acid burns. If the battery is overcharged, there is a risk that the battery
burns.
 Danger of acid burns. Do not open or heat the battery.

10.5 Cleaning
Cleaning removes dust, dirt and stains; however, this does not constitute a
disinfection. Use commercially available detergents intended for clinics, hospitals
and practices.

10.5.1 Detergents
Refer to the manufacturer's information regarding the detergents.

Admissible detergents • Isopropyl alcohol 70%

• Neutral detergents
• Soapy water
• All products that are suitable for ABS plastic

Non-admissible detergents Never use products containing the following:

• Ethyl alcohol
• Acetone
• Hexane
• Abrasive cleaning powder
• Plastic-dissolving products
Art. no: 0-48-0366 Rev: g

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10 Maintenance
10.6 Disinfection DEFIGARD HD-7

10.6 Disinfection
Use commercially available disinfectants intended for clinics, hospitals and
practices to disinfect the device.
Wipe disinfection removes certain bacteria and viruses. Refer to the
manufacturer's information.

10.6.1 Disinfectant

Admissible disinfectants • Isopropyl alcohol 70%

• Propanol (70 to 80%)
• Ethyl hexanal
• Aldehyde (2 to 4%)
• Ethanol (70 to 80%)
• All products that are suitable for ABS plastic

Non-admissible disinfectants Never use products containing the following:

• Organic solvents
• Ammonia-based detergent
• Abrasive cleaning agents
• 100% alcohol, Virex, Sani-Master
• Sani-Cloth, Ascepti or Clorox wipes
• HB Quat
• Conventional cleaner (for example, Fantastic or Tilex)
• Conductive solution
• Solutions or products containing the following ingredients:
– Ketone (Acetone)
– Ammonium chloride
– Betadine
– Chlorine, wax, or wax compound
– Sodium salt

10.6.2 Cleaning and disinfecting the device, cable and sensors

 Disconnect the device from the main supply and close the printer cover before
cleaning. Refer to section 3.2 Switching Off, disconnecting from the Mains
Supply.
 Do not immerse the unit, cable or sensors in liquid, and do not sterilise them.
 Do not apply tension to the sensor cable.
 Do not use aggressive cleaners.
 Do not use any phenol-based agents or peroxide compounds for cleaning.
Reusable sensors must be treated as biologically dangerous material after
Art. no: 0-48-0366 Rev: g


usage and disinfected according to the manufacturer's instructions.
 Observe the manufacturer's notes when cleaning the sensors and cables.

1. Disconnect the device from the mains and remove the plug and sensors.
2. Wipe the device(s), cable and sensors with a dampened cloth and a mild cleaning
solution. The manufacturer recommends using 70% alcohol.
3. Dispose of single-use sensors and protective coverings according to the relevant
regulations.

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 Maintenance 10
DEFIGARD HD-7 User guide Disinfection 10.6

Notes on the cleaning and disinfection

NIBP cuff The manufacturer recommends using 70% alcohol to clean and disinfect the NIBP
cuff and tube.

SpO2 sensor The manufacturer recommends using 70% alcohol to clean the cable and sensor. Dry
the sensor before reuse.

ECG cable The cable can be wiped with a mild cleaning agent or with 70% alcohol.

Paddles Remove the remaining gel from the metal surface with a mild cleaning agent and then
disinfect the surface with 70% alcohol.

Spoon electrode adapter The adapter can be wiped with a mild cleaning agent or with 70% alcohol.

Spoons with cable Refer to the following section 10.6.3 Spoon electrodes and cable cleaning/
disinfection/sterilisation

Nomoline Nomoline adapter may be cleaned using a cloth moistened (not wet) with a maximum
of 70% ethanol or isopropyl alcohol.

10.6.3 Spoon electrodes and cable cleaning/disinfection/sterilisation

 Before cleaning, disconnect the connection cable from the defibrillator.

 Do not, under any circumstances, immerse the spoon electrodes and connection
cable in liquid.
 The spoon electrodes and connection cable are sold and shipped in a non-sterile
condition. They should be cleaned and sterilised following the procedures
outlined below prior to first use and after each reuse.
 Do not drop, bump or knock the spoon electrodes. Damage to the insulating
coating of the spoons may occur.

 These recommendations do not replace the regulations on cleaning/sterilisation

issued by your clinic/institution.
 Observe the manufacturer's information regarding detergents/sterilisation and
the expiration date of the solution, if applicable.
 Always clean the spoon electrodes and connection cable before sterilisation
 Do not clean the connection cable in mechanical washers or ultrasonic cleaners.
Hand wash only.
 Do not allow the connection cable or spoon electrodes to dry after use and
before cleaning. Items contaminated with blood or other protein materials cannot
Art. no: 0-48-0366 Rev: g

be effectively cleaned if allowed to dry.

 Clean the spoon electrodes and connection cable with detergent usually used in
hospital environments, such as Anios Surfa'safe detergent or other detergent
and disinfectant foam.
 Remove the spoon electrodes and connection cable from service after 50 uses.

Procedure cleaning and disinfection

The spoon electrodes can be cleaned in Hospital washer-disinfectors using products

suitable for cleaning surgical instruments. This procedure only applies to the spoons.

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10 Maintenance
10.6 Disinfection DEFIGARD HD-7

1. Remove immediately after use; remove excess soiling by cleaning the cable and
spoons with a disposable cloth/paper.

2. Choose the cleaning/disinfectant solution (Anios Surfa'safe type) compatible with

the cable and spoons.
3. Spray the solution on a non-woven wipe, distribute the solution evenly over the
spoon or cable and check that the solution does not seep into the connector.
4. Respect the contact time: at least 5 minutes for a bacterial, yeast and virucidal ac-
tion (refer to the manufacturer’s information).
5. Rinse with a non-woven wipe soaked in de-mineralised water.
6. Leave the spoon and cable to air dry.
7. Inspect each spoon electrode after cleaning and prior to each sterilisation for:
– Nicks or burrs that may injure patient tissue;
– Scratches, pits, or gouges in the internal spoon surface;
– Loose, flaking or damaged insulating coating.
8. Visually inspect the spoon electrodes and connection cable for cleanliness. If nec-
essary, repeat the process above. The spoon electrodes and connection cable
must be free of any visible contamination prior to sterilisation.

Procedure steam sterilisation for spoons and cable

 Follow the establishment's packaging protocols, whether for individual bagged

or batch packaging.
 Spoon electrodes and connection cables must be thoroughly cleaned prior to
each sterilisation.
 Make sure the cable is coiled with a diameter of more than 15 cm. Never wrap
the cable around the handles, as this may hinder proper sterilisation.

• The spoon electrodes and connection cables can withstand up to 50 steam

sterilisation cycles.
• Date Code Identification:
– The date codes can be found on the back of the base of each spoon electrode
and one of the handles of the connection cable.

1. Coil the connection cable with a diameter of more than 15 cm. Make loose coils
to ensure effective sterilisation.
2. Pack the connection cable in a bag suitable for steam autoclave sterilisation.
3. Pack the spoons in a bag suitable for steam autoclave sterilisation.
4. Place the packed connection cable and the packed spoons in the steam auto-
15 cm clave. Do not place the spoons on the connection cable or vice versa.
5. Setup autoclave sterilisation with the following characteristics:
– Temperature: 134°C/0 to +3°C
– Exposure time: 18 minutes/0 to +2 minutes
– Drying time: 9 minutes/0 to +2 minutes
Art. no: 0-48-0366 Rev: g

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 Maintenance 10
DEFIGARD HD-7 User guide Disposal at the End of the Device's Useful Life 10.7

10.7 Disposal at the End of the Device's Useful

Life
This unit must be disposed of in a municipally approved collection point or recycling
centre when no longer used.

If no such collection point or recycling centre is available, you can return the unit to
your distributor or the manufacturer for proper disposal. In this way, you contribute to
the recycling and other forms of utilisation of old electrical and electronic equipment.

Improper disposal harms the environment and human health due to the presence of
dangerous substances in electrical and electronic equipment.
Art. no: 0-48-0366 Rev: g

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10 Maintenance
10.8 Inspection and Checklist Tables DEFIGARD HD-7

10.8 Inspection and Checklist Tables

In accordance with the maintenance interval detailed previously, the following
checklist should be copied and followed.

Checking life-saving functions

The following tests are recommended before or after each intervention. Refer to
sections 10.8.1 to 10.8.3. Enter the results in the checklist.

• Visual inspection of the device and accessories (refer to section 10.2.1 Visual
inspection of the device and accessories).
• For the battery charging status; refer to section 10.2.2 Battery check
• Defibrillator shock test; refer to section 10.2.3 Defibrillator shock test
• Self-test in the Post-intervention menu; refer to section 10.2.4 Self-test.
Year Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Jan.
Feb.
Mar.
Apr.
May
June
July
Aug.
Sept.
Oct.
Nov.
Dec.

10.8.1 Monthly
Functional test, charging the capacitor with maximum energy. This is completed with
the self-test function (refer to section 10.2.4 Self-test).

Month Date Periodic test results OK Periodic test results NOT OK

1  
2  
3  
4  
Art. no: 0-48-0366 Rev: g

5  
6  
7  
8  
9  
10  
11  
12  

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 Maintenance 10
DEFIGARD HD-7 User guide Inspection and Checklist Tables 10.8

10.8.2 Every 12 months

Inspection Results Inspection
Functional safety checks and in-
spections
 Confirm the date of the last • Return the unit to your nearest
factory inspections and tests. authorised service point or your
    
SCHILLER agent for safety and
functional checks.
Date of replacement:
Inspector:

10.8.3 Lifed-item replacement every 5 to 10 years

Inspection Results Replacement
Battery
 Replace battery • The battery needs to be replaced:
– When the operating time is less
    
than 2 hours or after 3 to 5
years; refer to section     
10.4.1 Replacing the batteries
– Replace the internal button pri-
mary cell (every 10 years)     

Date of replacement:
Inspector:
Defibrillation capacitor
 Replace defibrillation capacitor. • Send the unit to your nearest
SCHILLER service centre for
capacitor replacement if the
defibrillation capacitor deviates
more than 15% [joule] from the     
intended value.
Date of replacement:
Inspector:
Art. no: 0-48-0366 Rev: g

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10 Maintenance
10.9 Error Detection DEFIGARD HD-7

10.9 Error Detection

 If a technical alarm is still present at shutdown, a reminder is displayed.
 If it is not possible to get the device back into operating condition within a
reasonable time, continue CPR.

10.9.1 General errors

Error Cause Remedy
• The device is in transport mode  Connect to the power supply and switch the device ON
The screen is not lit when  Connect to the power supply and charge the battery
• The battery is empty
the device is switched ON.
• The device is defective  Replace device

• Software hangs  Turn the rotary switch to the OFF position. The device in-
The device cannot be itiates a shutdown after a maximum of one minute
switched OFF.
• The device is defective  Replace device

• ECG signal too weak  Perform cardiac massage again

• ECG signal interference through  Turn OFF the source of signal interference, for example,
electromagnetic waves radio equipment or cell phone, or move the patient out-
No analysis side the field of interference
• The patient moved or was
touched during analysis  Do not move or touch the patient during analysis
• The device is defective  Replace device

• Battery too low  Change batteries

• Electrode error caused by re-  Reapply new electrodes
suscitation measures
Unable to deliver shock • Heart rhythm has changed  Run new analysis
(DEFIGARD HD-7) • The device is defective  Replace device
• Using degraded defibrillation  Reapply new electrodes
pads (see the expired date on
the packaging)
 Let the device cool down, if possible; charging is contin-
The battery is not being • The temperature in the device or
ued once the temperature has reached an acceptable
charged battery is too high.
level.

Art. no: 0-48-0366 Rev: g

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 Maintenance 10
DEFIGARD HD-7 User guide Error Detection 10.9

10.9.2 Technical information and error messages

Alarm Cause Remedy
• T.CPU01  Replace device
• T.CPU02
• T.CPU03
CPU BOARD INOPERATIVE • T.CPU04
• T.CPU05
• T.CPU06
• T.CPU07

• T.CPU08 (T_PWR14 for SW ≥ 2.x)  Replace device

BACKUP BATTERY EMPTY
• T.CPU09 (T_PWR15 for SW ≥ 2.x)

• T.CPU10  Replace device

SAFE BATTERY EMPTY
• T.CPU11

LOW POWER BATTERY • T.CPU12 (T_PWR01 for SW ≥ 2.x)  Replace device

POWER BATTERY EMPTY • T.CPU13 (T_PWR02 for SW ≥ 2.x)  Replace device

POWER BATTERY CHARGE FAILURE • T.CPU14  Replace device

• T.ECG01  Replace device

• T.ECG02
• T.ECG03
• T.ECG04
• T.ECG05
ECG INOPERATIVE
• T.ECG06
• T.ECG07
• T.ECG08
• T.ECG09
• T.ECG10

DEFI INOPERATIVE (DEFIGARD HD-7) • T.ECG11  Replace device

Art. no: 0-48-0366 Rev: g

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10 Maintenance
10.9 Error Detection DEFIGARD HD-7

10.9.3 Preventing electromagnetic interferences

The user can help avoid electromagnetic disturbances by keeping the minimum
distance between portable and mobile RF telecommunication devices (transmitters)
and the DEFIGARD HD-7. The following table shows an overview of the different
mobile telecommunication devices/services, which must not be used within a radius
of 0.3 meters from the DEFIGARD HD-7.
Non-ionising electromagnetic radiation

HF source wireless communications devices Transmitter Testing Maximum Distance d

frequency frequency power P [m]
[MHz] [MHz] [W]
385
Various radio services (TETRA 400) 380-390 1.8 0.3

- Walkie-talkies (FRS)
430-470 450 2 0.3
- Rescue service, police, fire brigade, servicing (GMRS)

LTE band 13/17 704-787 710/745/780 0.2 0.3

- GSM800/900
- LTE band 5 800-960 810/870/930 2 0.3
- Radiotelephone (microcellular) CT1+, CT2, CT3

- GSM1800/1900
- DECT (Radiotelephone) 1720/1845/
1700-1990 2 0.3
- LTE Band 1/3/4/25 1970
- UMTS

- Bluetooth, WLAN 802.11b/g/n

- LTE Band 7
2400-2570 2450 2 0.3
- RFID 2450 (active and passive transponders and reading
devices)

5240/5500/
WLAN 802.11a/n 5100-5800 0.2 0.3
5785

 Portable HF telecommunication devices must not be used within a radius of

0.3 m from the DEFIGARD HD-7 and its cables.
 Do not place the DEFIGARD HD-7 on top of other electric/electronic devices;
that is, maintain a sufficient distance from other devices (this includes the patient
cables).

For permanent HF telecommunication devices (for example, radio and TV), the
recommended distance can be calculated using the following formula: d = 1.2  P
for 150 kHz to 800 MHz and d = 2.3  P for 800 MHz to 2.7 GHz
Art. no: 0-48-0366 Rev: g

d = Recommended minimum distance in meters

P = Transmitting power in Watts

For more detailed information; refer to section 11.7 Electromagnetic Interferences.

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 Maintenance 10
DEFIGARD HD-7 User guide Error Detection 10.9

10.9.4 Measures to prevent electromagnetic interference

The user can take the following measures to prevent electromagnetic interference:

 Increase distance to the source of interference.

 Turn the device to change the angle of radiation.
 Connect the device to a different mains connector.
 Only use original accessories (especially patient cables).
 Immediately replace defective cables, especially patient cables, with defective
sheathing.
 Make sure the patient cable is securely screwed on.
 Observe the maintenance intervals as stated in section 6.1 Maintenance interval.
Art. no: 0-48-0366 Rev: g

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11 Technical Data
11.1 System Data DEFIGARD HD-7

11 Technical Data
Data refer to standard testing conditions.

11.1 System Data

Manufacturer SCHILLER MEDICAL

Device type Defibrillator/Monitor

Device name DEFIGARD HD-7

Dimensions 322 x 276 x 209.7 mm (h x l x w) without bag

Weight 5.00 kg without paddles

6.25 kg with paddles

Protection case
Ingress protection • IP33
Free fall • 0.5 meter, according to EN1789+A2: 2014
Transport • Occasional with medical vehicles - Road ambulances, device powered by its
battery according to EN1789+A2: 2014

Mains supply 100 - 240 VAC, 120 VA, 50/60 Hz

2 x Fuse 2.5 AT 250V

Power battery
Battery type Lithium/ion 11V, 6.4 Ah, 70.4 Wh

200 shocks with maximum energy or 8 hours of monitoring with 32 NIBP

Autonomy
measurements.

Charging time 90%: 2:30 hours after full discharge and device switched OFF.

100%: 3 hours after full discharge and device switched OFF.

Environmental conditions
For operation • 0 to 45ºC relative humidity at 10 to 95% (non-condensing)
The device can be used up to 45°C and applied parts may have the same
temperature, for example, the pulse oximeter sensor
Art. no: 0-48-0366 Rev: g

• Atmospheric pressure 650 to 1060 hPa

• If higher or lower temperatures prevail during use, a limited operation time of up
to 1 hour is possible if the device has been stored previously at room
temperature.

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 Technical Data 11
DEFIGARD HD-7 User guide System Data 11.1

Environmental conditions
For Transport and storage • -10 to +50°C relative humidity at 10 to 95% (non-condensing)
between uses • Atmospheric pressure 650 to 1060 hPa

Time for warming up/cooling • 30 minutes

down Time required for the DEFIGARD HD-7 to warm or cool from the minimum/
maximum storage temperature between uses until the device is ready for its
intended use when the ambient temperature is 20°C.

Environmental conditions
Defibrillation electrodes
Storage • 0 to 50ºC
Storage maximum 10 days • -40 to 75ºC

Display
Type • High-resolution colour LCD capacitive touch screen, protected by tempered glass
Dimensions • 7“ (154 x 85.92 mm)

Printer High-resolution thermal head printer

Channels 3
Speed 25 or 50 mm/s
Paper format Roll, 80 mm, 27 meters length

Alarm sound level 62 to 73 dBA for all alarm levels

Connections ECG patient cable, SpO2, NIBP, CO2

Interfaces USB

Memory 24 hours memory (FIFO)

Recording of Defi, ECG Lead II, Impedance curves, Events, CPR feedback,
patient data, patient vitals, screenshots

Safety standard IEC/EN 60601-2-4

The device is designed for intensive use.

EMC • IEC/EN 60601-1-2

• IEC/EN 60601-2-4
• CISPR 11 class B
The device can be exposed to the following interferences without any impairment:

• Static discharges up to 15 kV
• Field strength up to 20 V/m in the radio frequency range of (80 to 2700 MHz,
5 Hz/1 kHz modulated)
Art. no: 0-48-0366 Rev: g

• Magnetic fields of 100 A/m, 50/60 Hz

Conformity CE according to Directive 93/42/EEC Class IIb

Protection class Class I according to IEC/EN 60601-1 for continuous use.

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11 Technical Data
11.2 Defibrillation Waveform DEFIGARD HD-7

11.2 Defibrillation Waveform

Waveform • Pulsed biphasic truncated exponential waveform Multipulse Biowave with fixed
pulse duration and variable phase duration for impedance compensation.
• The impedance range for shock delivery is 25 to 250 Ohms.
Graphical plots • Delivered energy output curves in function of patient impedance. Each curve
corresponds to a rated energy selection.

Waveform shape of delivered

Current [A]
current in function of time in
milliseconds for different
impedances ranging from 25 to 175
 at 200 joules of selected energy.

Time [ms]

Waveform shape of delivered

Current [A]

current in function of time in

milliseconds for different
impedances ranging from 25 to 175
 at 50 joules of selected energy

Time [ms]
Delivered energy [J]

Delivered energy output curves in

function of patient impedance. Each
curve corresponds to a rated energy
selection.
Art. no: 0-48-0366 Rev: g

Patient Impedance []

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 Technical Data 11
DEFIGARD HD-7 User guide Defibrillation Waveform 11.2

Accuracy of delivered energies

Rpat [] 25 50 75 100 125 150 175

The accuracy of the measured Rated Deviation from the rated delivered energy (1 to 200 J) at 25 to 175 Rpat
delivered energy for each couple of delivered []: 3 J or 15% (the higher value is assumed)
most of the rated delivered energies energy [Joules]
and impedance values. 25 to 175  is
the required range for impedance 10 ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J
compensation as required by the IEC
60601-2-4 standard. 15 ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J

20 ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J ± 3J

30 ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%

50 ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ±1 5%

100 ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%

150 ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%

200 ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%

Standard energy settings

AED
Adult 150/200/200 joules (configurable refer to section 11.6.2 Defibrillator)
Paediatric 50/50/50 joules (configurable refer to section 11.6.2 Defibrillator)
(automatically selected when the paediatric or adult electrodes are connected)
Manual mode
Adult 150 joules (configurable; refer to section 11.6.2 Defibrillator)
The following energies can be selected:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 30, 50, 70, 90, 100, 120, 150,170,
200 joules
Paediatric
50 joules (configurable; refer to 11.6.2 Defibrillator)
The following energies can be selected:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 30, 50, 70, 90 joules

Internal Defibrillation The following energies can be selected:

(Spoons) 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 30, 50 joules

(Bold = default energy settings when starting in Manual mode, adjustable anytime
during intervention)
Art. no: 0-48-0366 Rev: g

Charging time for shock [150 Time used to charge the storage capacitor to the recommended energy of 150
joules] joules in Manual mode:

• With a new fully charged battery < 7 seconds

after 15 discharges

• With mains voltage (rated or 90%

5 seconds
rated)

Charging time for shock [200 Time used to charge the storage capacitor to the maximum energy of 200 joules
joules] in Manual mode:

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11 Technical Data
11.2 Defibrillation Waveform DEFIGARD HD-7

• With a new fully charged battery 8 seconds

after 15 discharges

• With mains voltage (rated or 90%

6 seconds
rated)

• From switching on the device with a

new fully charged battery after 15 19 seconds
discharges

• From switching on the device with 15 seconds

mains voltage

Cycle Time Rhythm Analysis –

Shock Standby in AED Mode

• With a fully charged battery 1st shock = 11 seconds maximum

• With mains voltage after 15

1st shock = 11 seconds maximum
discharges with maximum energy

• From switching on the device to 1st shock = 23 seconds

charge at maximum energy

Cycle time shock to shock < 15 seconds

Operating Modes • Synchronised with heart action < 60 ms after R wave

• Non-synchronised
• AED

Charge control and monitoring • Automatic shock recommendation of analysis in AED mode
• Direct via touch screen or paddles
• Display of selected energy

Patient resistance 25 to 250 

Indication when ready to shock

LED below on the device or this key on the paddles is lit

Shock delivery
Using the key on the device or this key on the paddles
Art. no: 0-48-0366 Rev: g

Page 140
 Technical Data 11
DEFIGARD HD-7 User guide Defibrillation Waveform 11.2

Safety discharge when: • The battery voltage is insufficient

• The shock is not released within 20 seconds
• A lower energy value is selected while the defibrillator is charging
• The device is defective
• The device is turned OFF
• A non-shockable rhythm is detected

Shock delivery • Via applied disposable adhesive defibrillation electrodes via the paddles or the
spoons.

Defibrillation electrode Type CF, defibrillation-protected > 5 kV

connection

Defibrillation electrodes Electrode cable, 2 meters long

Adult electrodes • 80 cm² active surface

Paediatric electrodes • 42 cm² active surface

Adult paddles • 69.5 cm² active surface

Paediatric paddles • 17.4 cm² active surface

Spoons • Spoon electrodes, 67 x 88 mm - 54 cm²

• Spoon electrodes, round 64 mm - 32 cm²
• Spoon electrodes, round 28 mm - 6 cm²
• Spoon electrodes, round 45 mm - 16 cm²
• Spoon electrodes, oval 43 x 27 mm - 9 cm²
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11 Technical Data
11.2 Defibrillation Waveform DEFIGARD HD-7

11.2.1 Shock Advisory System (SAS)

References:

[1]: Kerber, R. E., L. B. Becker, J. D. Bourland, R. SAS validation process

O. Cummins, A. P. Hallstrom, M. B. Michos, G.
Nichol, et al. 1997. «Automatic external defibrilla- SCHILLER AEDs are highly sophisticated, microprocessor-based devices
tors for public access defibrillation: recommenda- embedding a SAS that analyse multiple features of the electrical signal (ECG)
tions for specifying and reporting arrhythmia analy- received from the patient’s heart. The ECG signal is acquired via the defibrillation
sis algorithm performance, incorporating new
waveforms, and enhancing safety. A statement for electrode pads, usually in antero-lateral or also called sterno-apical position
health professionals from the American Heart As- (equivalent to a lead II ECG). For paediatric patients (under 8 years), the antero-
sociation Task Force on Automatic External Defi-
brillation, Subcommittee on AED Safety and Effica-
posterior position of the defibrillation pads is recommended.
cy». Circulation 95 (6): 1677-82.
SCHILLER AEDs are thought to be operated by rescuers who do not need to
[2]: Standard IEC 2010 60601-2-4, ed 3
recognise or interpret heart rhythms. For this reason, the SAS is an essential
[3]: Didon, Jean-Philippe, Vessela Krasteva, Sarah component of the AED.
Menetre, Todor Stoyanov, et Irena Jekova.
2011.«Shock Advisory System with Minimal Delay
Triggering after End of Chest Compressions: Accu- An SAS should recommend:
racy and Gained Hands-off Tim ». Resuscitation,
Proceedings of the Eleventh Wolf Creek Confer-
ence, 82 (décembre): S8-15. https://doi.org/
• A shock if the analysed rhythms is a lethal ventricular arrhythmia: either a VF or a
10.1016/S0300-9572(11)70145-9. rapid VThi
[4]: Didon, Jean-philippe, Irena Jekova, Sarah
• No shock for non-shockable ECG rhythms.
Ménétré, Todor Stoyanov, et Vessela Krasteva.
2011.« Abstract 219: Combination of Algorithms to Detailed descriptions of the shockable/non-shockable rhythms categories are given
Decrease Preshock Pause for Automated External
Defibrillators ». Circulation 124 (suppl_21): in the following section:
A219-A219. https://doi.org/10.1161/circ.124.sup-
pl_21.A219.
A rhythm analysis by the SAS is requested and is run automatically and periodically
[5]: Didon, Jean-Philippe, Sarah Menetre, Irena Jek- after each CPR period. In some AED models, the operator needs to press a button to
ova, et Vessela Krasteva. 2010. « Abstract 253: initiate the rhythm analysis. A rhythm analysis requires from 5 to 10 seconds,
Method for Minimal Delay Triggering of VF Detec-
tion During Cardio Pulmonary Resuscitation ». Cir- depending on the SAS configuration.
culation 122 (suppl_21): A253-A253. https://
doi.org/10.1161/circ.122.suppl_21.A253. The performance of the SAS embedded in SCHILLER AEDs is evaluated on two
[6]: Greenwald, Scott D. 1992. «The MIT-BIH Malig- criteria: Sensitivity (Se) and Specificity (Sp). Se refers to the AED’s ability to detect
nant Ventricular Arrhythmia Databas ». physio- life-threatening ventricular arrhythmias. Sp refers to the AED’s ability to detect normal
net.org. https://doi.org/10.13026/C22P44.
sinus rhythms or arrhythmias that should not be shocked.

The American Heart Association (AHA) task force published a consensus document
[1] reflecting the views of the AHA scientific members on AED’s SAS validation. This
document is intended to supplement existing AED SAS performance requirements
from the IEC standard [2].

Art. no: 0-48-0366 Rev: g

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DEFIGARD HD-7 User guide Defibrillation Waveform 11.2

Validation databases
The process of validation of SAS uses two independent ECG signal databases, one
for learning and one for validation.

Each database is composed of recordings from holter systems and SCHILLER

Medical AEDs. Moreover, each database includes both adult and paediatric
recordings.

The diagnostic bandwidth of holter signals (0,05 to 150 Hz) has been limited to (0,5
to 30 Hz) so that the frequency content of the signals is typical of the one found in
SCHILLER Medical AED recordings.

Validation DBs Recording Patient type Number of Number of 10s-ECG

method patients segments
PhysioNet MIT-VFDB [6] Holter Adult 21 567

Paediatric 7 years
IH DB 47 69
Holter IQR [5 to 8] years

AED
OHCA DB SCHILLER FRED Adult 733 1132
EASY

AED Paediatric 8 years

OHCA DB SCHILLER FRED IQR [0.5 to 16] 188 275
EASY years

All DBs 989 2043

Table 1:
Summary of ECG databases used for SAS validation. MIT-VFDB stands for MIT-BIH
Malignant Ventricular Arrhythmia Database and is a subset of the general PhysioNet
database recognised as standard in ECG tests. Key: Data Base (DB), Intra-Hospital
(IH) and Out-Of-Hospital Cardiac Arrest (OHCA).

ECG Annotations
The rhythm annotation is performed by expert observation on 10-second ECG
segments/strips (one ECG channel). At least three expert decisions (for example,
emergency physicians, experienced cardiologists, electrophysiologists, and
biomedical engineers) are combined for a consensus rhythm annotation. The rhythm
annotation follows the AHA classification scheme [1], defining the following rhythm
types:

Shockable rhythms • VF as coarse VF (> 200 µV peak-to-peak amplitude);

• VThi as rapid VT HR > 150 bpm, rushes that last more than 8 seconds).

Non-shockable rhythms • Asystole as asystole (peak to peak amplitude ≤ 100 µV) for more than 4 seconds;
Art. no: 0-48-0366 Rev: g

• NSR as Normal Sinus Rhythm (P-QRS-T waves visible, HR > 40 bpm and HR <
100 bpm);
• N as another non-shockable rhythm (includes all rhythms except those in other
listed categories:
– For example. AF/Flutter, Sinus Bradycardia (SB), Supraventricular Tachycardia
(SVT), Premature Ventricular Contractions (PVCs), and Heart Blocks (HB), as
mentioned in [1]).

Intermediate rhythms • VT lo as other VT (HR > 40 bpm and < 150 bpm, more than 3 rushes);
• Fine VF as fine VF (peak-to-peak amplitude > 100 µV and ≤ 200 µV) during more
than 4 seconds.

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11.2 Defibrillation Waveform DEFIGARD HD-7

SAS Performance
The performance of SAS shown in the tables below is above expectations according
to AHA recommendations [1] and IEC standards [2]. Thereby, SCHILLER AEDs
embedded SAS are effective and safe to be used on patients.
The performance of the algorithm is evaluated by comparing the SAS decision with
the consensus diagnosis of three expert annotators.

An interpretation table is built and shows:

• The True Positive (TP) is a correct classification of a shockable rhythm;

• The True Negative (TN) is a correct classification of a non-shockable rhythm
(Asystole or N or NSR);
• The False Positive (FP) is a non-shockable rhythm (Asystole or N or NSR) that has
been incorrectly classified as a shockable rhythm;
• The False Negative (FN) is a VF or VThi that has been incorrectly classified as non-
shockable;
• The Se of the device for shockable rhythms is:
– Se_VF = TP/TP + FN), applied to VF rhythms
– Se_VThi = TP/(TP + FN), applied to VThi rhythms
• The True Predictive value (TPv) is the probability that a shock is needed when the
AED recommends it:
– TPv = (TP)/(TP+FP) applied to both VF and VThi results
• The Sp of the device for non-shockable rhythms is:
– Sp_NSh = TN/(FP+TN)
• The False Positive rate (FPr) is:
– FPr = FP/(FP+TN), applied to non-shockable rhythms

The test sample sizes proposed per category reflect a balance between reasonable
confidence in performance and realistic limits on data available to demonstrate it. The
minimum sample sizes defined to reach significant results may be exceeded. One
parameter to measure this significance is the 90% single-sided lower confidence limit
(LCL 90%). For each rhythm category, the LCL 90% should be calculated based on
test results. This process gives a 90% probability that the actual performance is
greater than the lower confidence limit calculated. In other words, this value indicates
if the computed Se and Sp have a low enough disparity in accordance with the
number of analysed segments. For each category, the observed test results, Se, Sp
and LCL 90% must equal or exceed the performance goal.

Rhythms Minimum test Test sample Performance goal Observed performance

sample size size
Se, SP (%) LCL 90% Se, SP (%) LCL 90%

VF 200 571 Se > 90% > 87% Met [1] Met [1]

VThi 50 213 Se > 75% > 67% Met [1] Met [1]
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NSR 100 118 Sp > 99% > 97% Met [1] Met [1]

N 30 452 Sp > 95% > 88% Met [1] Met [1]

Asystole 100 634 Sp > 95% > 92% Met [1] Met [1]

Intermediate rhythms
VFlo 25 26 Report only Report only > 10% shocked NA

Fine VF 25 29 Report only Report only > 40% shocked NA

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 Technical Data 11
DEFIGARD HD-7 User guide Defibrillation Waveform 11.2

NA stands for “Not Applicable” Table 2: Performance for SAS (VFDetectClean V2.031) as required by AHA (Artefact
Free ECG samples) [1].

VF VThi Non-shockable rhythms

NSR/N/Asystole
Shock 546 204 9

No Shock 25 9 1195

Performance goal Sensitivity > 90% Sensitivity > 75% Specificity > 95%

Observed performance Met [2] Met [2] Met [2]

Additional performance without a goal:

> 90%

NA

Table 3: Performance for SAS (VFDetectClean V2.031) as required by IEC standard

(Artefact Free ECG samples) [2].
NA = Not Applicable

SAS Configuration
The SAS embedded in the device can be configured as an Analysis with anteriority.
This SAS setting uses a combination of algorithms, which are launched in two stages
[3 to 5] to deliver a shock advisory decision at a minimal delay after the end of chest
compressions. The SAS configured as Analysis without anteriority starts a chest
compression-free VF detection at an analysis request without trying to optimise
hands-off time. In both configurations, the SAS does not continue analysing after a
shock-advised decision is reached.
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11 Technical Data
11.3 Pacemaker DEFIGARD HD-7

11.3 Pacemaker
Operating Modes • Demand
• Fixed frequency (FIX)

Stimulation pulse
Form Rectangle mono-phase with constant current source
Pulse duration 20 ms ± 5%
Pulse rate Configurable in steps of 40, 45, 50, 60, 70 to 240 bpm ± 1.5%
Pulse current Configurable to 0 (pacemaker OFF) and then from 10 to 200 mA, ± 10% or 5 mA (the
higher value is applied)

Refractory period • 340 ms 80 bpm

• 240 ms > 80 bpm

Signal connection Type BF, defibrillation-protected > 5 kV

Readiness for operation Immediately

Pacer electrodes Electrode cable, 2 meters long

(same as defibrillation electrodes)
Deviating from the compliance statement according to 201.108.1.10 (IEC60601-2-
4, 201.1.108.7. and 201.1.108.6), the following features have been measured for the
universal electrode.

Adult electrode 80 cm2 active surface

Duration • For up to 1 hour of pacing using 140 mA/120 ppM (pulse duration 20 ms)
• For up to 8 hours of pacing using 70 mA/60 ppM (pulse duration 20 ms) with
inspection of pads every 30 minutes

Paediatric electrode 42 cm2 active surface

Duration • For up to 1 hour of pacing using 70 mA/140 ppM (pulse duration 20 ms) with
inspection of pads every 30 minutes

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 Technical Data 11
DEFIGARD HD-7 User guide Technical Data (Monitoring) 11.4

11.4 Technical Data (Monitoring)

11.4.1 ECG

Leads Simultaneous, synchronous recording of all 6 leads

Patient cable 4-wire cable type CF

HR
Range • 15 to 350 bpm
Accuracy • ± 10% or 5 beats/minute, whichever is greater

Lead display Up to 6 leads

Sensitivity 0.25, 0.5, 1, 2 cm/mV programmable

Blockage caused by a defibrillation Maximum 5 seconds

shock

Input impedance > 2.58 M

Current electrode test < 0.5 A

Suppression of large T-waves Maximum amplitude of T-wave according to IEC 60601-2-27 section
201.12.1.101.17: 0.8 mV

HR averaging method The HR calculation is done using a user-defined number of previous RR intervals
(minimum 4, maximum 16).

The RR intervals are reset, and the HR is set to zero whenever an asystole condition
has been detected

Response time HR measurement Change from 80 to 120 bpm: 2.56 seconds

Change from 80 to 40 bpm: 8 seconds

Reaction to an irregular rhythm • A1: 80/minute

• A2: 60/minute
• A3: 120/minute
• A4: 90/minute (except for triggers no. 6 and 7, HR < 90/minute)
(according to IEC specifications 60601-2-27, 6.8.2.bb)

Duration until the alarm is triggered B1 and B2 (0.5, 1, 2 amplitude): 3 seconds (according to IEC specification 60601-
in the case of tachycardia 2-27, 6.8.2.bb)

ECG amplifier
Sampling rate 500 Hz
Pacemaker detection ± 2 mV to ± 700 mV0.1 to 2.0 ms
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QRS detection range Duration: 70 to 120 ms, amplitude: 0.5 to 5.0 mV

Protection Fully isolated, defibrillation-protected > 5 kV
Mains filter Distortion-free suppression of superimposed 50/60 Hz sinusoidal interferences by
means of adaptive digital filtering.

The ECG frequency range depends on the ECG cable, the ECG view and the
Frequency range
selected settings (refer to the table on the next page).

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11 Technical Data
11.4 Technical Data (Monitoring) DEFIGARD HD-7

ECG amplifier bandpass The bandpass depends on the ECG source and Filter settings:

Patient cable BLW Filter EMG Filter Display

4 leads OFF OFF 0.04 to 42 Hz
4 leads ON ON 0.6 to 25 Hz
4 leads ON OFF 0.6 to 42 Hz
4 leads OFF ON 0.04 to 25 Hz
Defibrillator - - 1 to 25 Hz

11.4.2 Features of pacemaker pulse rejection

According to IEC 60601-2-27 Clause 201.12.1.101.13

Single pacemaker pulse • Duration 2.0 ms, amplitude > 2 mV and an overshoot of < 0.25mV
Followed by a QRS complex • Duration 0.1 ms, amplitude > 2 mV and an overshoot of < 0.8mV

Not followed by a QRS com- • Duration 2 ms, amplitude > 2 mV and an overshoot of < 10 mV
plex • Duration 0.1 ms, amplitude > 2 mV and an overshoot of < 20 mV

Pacemaker pulse followed by an • Duration 2.0 ms, amplitude < 100 mV without overshoot
identical pulse within 150 ms • Duration 0.1 ms, amplitude < 100 mV without overshoot
Followed by a QRS complex

Not followed by a QRS complex • Duration 2.0 ms, amplitude < 100 mV without overshoot
• Duration 0.1 ms, amplitude < 100 mV without overshoot

Pacemaker pulse followed by an • Duration 2.0 ms, amplitude < 100 mV without overshoot
identical pulse within 250 ms • Duration 0.1 ms, amplitude < 100 mV without overshoot
Followed by a QRS complex

Not followed by a QRS complex • Duration 2.0 ms, amplitude < 100 mV without overshoot
• Duration 0.1 ms, amplitude < 100 mV without overshoot

Note that pacemaker signals from different pacemakers vary. In the case of cardiac
arrests or some arrhythmias, pacemaker signals might still be measured, especially
signals from pacemakers generating high amplitudes (> 20 mV) or overshoot.
Pacemaker patients need to be monitored very closely.

11.4.3 NIBP

Measurement Automatic or manual

Measuring method Oscillometric

Connection Type CF
Art. no: 0-48-0366 Rev: g

Measurement range
Adults (Child) • Sys 30 to 255 mmHg, dia 15 to 220 mmHg
Neonate • Sys 30 to 135 mmHg, dia 15 to 110 mmHg

Accuracy ± 3 mmHg and ± 2 bpm

Standards Complies with ISO 81060-2: 2013

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 Technical Data 11
DEFIGARD HD-7 User guide Technical Data (Monitoring) 11.4

11.4.4 SpO2 - Pulsoximetry Masimo

Amplifier Masimo

Patent See website: www.masimo.com/patents.htm for detailed patent information.

Operation Normal and sensitive

Measuring range
SpO2 • 0 to 100%
PP • 25 to 240 p/minute
PI • 0.02 to 20%

Accuracya
SpO2 (no movement) • 60 to 80% ± 3% adults/children (10 to 50 kg)/infants (3 to 20 kg)
• 70 to 100% ± 2 adults/children/infants; ± 3 neonates
SpO2 (movement) • 70 to 100% ± 3 adults/children/infants/neonates
SpO2 (low perfusion) • 70 to 100% ± 2 adults/children/infants/neonates
PP (no movement) • 25 to 240/minute ± 3 digits adults/children/infants/neonates
PP (movement) • 25 to 240/minute ± 5 digits adults/children/infants/neonates
PP (low perfusion) • 25 to 240/minute ± 3 digits adults/children/infants/neonates

Resolution
SpO2 1%
PP 1 minute

Calibration range 70 to 100%

Connection Type CF

Displayed range 1 to 100%

Blockage caused by a defibrillation Maximum 10 seconds

shock

Skin surface temperature Less than 41°C in a minimum 35°C environment

a. SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range of 60 to 100% SpO2, 0 to 40% SpCO,
and 0 to 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in
age from 7 to 135 days old and weighing between 0.5 to 4.25 kg. Seventy-nine (79) data samples were collected over a range of 70 to 100%
SpO2 and 0.5 to 2.5% MetHb with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet.

The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light
to dark skin pigmentation in induced hypoxia studies in the range of 70 to 100% SpO2 against a laboratory CO-oximeter and ECG monitor. This
variation equals plus or minus one standard deviation, which encompasses 68% of the population.

The Masimo SET Technology has been validated for low perfusion accuracy in benchtop testing against a Biotek Index 2 simulator and Masi-
mo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This
Art. no: 0-48-0366 Rev: g

variation equals plus or minus one standard deviation, which encompasses 68% of the population.

The Masimo sensors have been validated for pulse rate accuracy in the range of 25 to 240 bpm in benchtop testing against a Biotek Index 2
simulator. This variation equals plus or minus one standard deviation, which encompasses 68% of the population.

The following substances may interfere with pulse CO-Oximetry measurements:

- Elevated levels of Methaemoglobin (MetHb) may lead to inaccurate SpO2 and SpCO measurements
- Elevated levels of Carboxyhaemoglobin (COHb) may lead to inaccurate SpO2 measurements.
- Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements
- Severe anaemia may cause erroneous SpO2 readings.
- Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
- Elevated levels of total bilirubin may lead to inaccurate SpO2, SpMet, and SpCO readings.

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11 Technical Data
11.4 Technical Data (Monitoring) DEFIGARD HD-7

11.4.5 SpO2 - Pulsoximetry Nellcor

Sensor name Nellcor

Operation Normal and Fast

Measuring range
SpO2 1 to 100%
PP 20 to 300 bpm
PI 0.03 to 20%

Accuracya
Saturation

Adultb,c, 70 to 100% ± 2 digits

Adult and Neonates low Sat b,c,b 60 to 80% ± 3 digits

Neonated,c 70 to 100% ± 2 digits

Low Perfusiond 70 to 100% ± 2 digits

Adult and Neonates with 70 to 100% ± 3 digits

motionb,c,d

Pulse rate

Adult and Neonatesb,c,d 20 to 250 bpmd ± 3 digits

Low perfusion 20 to 250 bpmh ± 3 digits

Adult and Neonates with motion 48 to 127 bpm ± 5 digits

Blockage caused by a defibrillation Maximum 10 seconds

shock

Skin surface temperature Less than 41°C in a minimum 35°C environment

a. Saturation accuracy varies by sensor type. Contact Medtronic for sensor accuracy information.
b. Neonate specifications are shown for OXIMAX MAXN sensors with the Nellcor NELL1SR.
c. Clinical functionality of the MAXN sensor has been demonstrated on a population of hospitalised neonate patients. The observed SpO2 accu-
racy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4,100 grams, and 63 observations made spanning a range
of 85 to 99% SaO2.

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 Technical Data 11
DEFIGARD HD-7 User guide Technical Data (Monitoring) 11.4

11.4.6 EtCO2 - Capnography

The ISA sensor is equipped with an automatic barometric pressure and temperature
compensation.

The ISA is a compact, low-flow sidestream gas analyser with an integrated pump,
zeroing valve and flow controller.

Trademarks Masimo ISA, Nomoline

Masimo AB patents ISA: US 9.861.298; EP 2.065.697

Standards MDD 93/42/EEC, EN ISO 80601-2-55, IEC 60601-1, IEC 60601-1-2, EN ISO
5356-1, EN 1789

Modules Masimo ISA sidestream

Measuring range 0 to 25%

Accuracy The following specifications are valid for a dry gas at 22 ± 5°C and 1013 ± 40 hPa
(standard conditions).

In standard conditions • 0 to 15% (± 0.2 vol% + 2% of reading)

• 15 to 25% (no information on accuracy)

In all conditions • ± (0.3 kPa + 4% of reading)

Breath detection Adaptive threshold value, minimum 1 vol% change in CO2 concentration

RR 0 to 150/minute. The RR is displayed after three breaths, and the average value is
updated after every breath.

Warm-up time < 10 seconds

Rise time CO2 < 200 ms

Total system response time < 3 seconds (using a 2 meters long sampling line)

Airway adapters NomoLine

Adults/Paediatric adapter ≤ 6 ml dead space
Infant/Neonate adapter ≤ 0.7 ml dead space

Water handling ISA NomoLine: A family sampling line with proprietary water removal tubing

Sampling rate 1 second

Art. no: 0-48-0366 Rev: g

Sampling flow rate ISA 50 (± 10) ml/minute

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11 Technical Data
11.4 Technical Data (Monitoring) DEFIGARD HD-7

Fi and ET Fi and End-Tidal (ET) are displayed after one breath and have a continuously
ET is measured at an I/E ratio of 1:1 using a updated breath average.
breath simulator according to EN ISO
80601-2-55 fig. 201.101. 5 Measured The following methods are used to calculate ET values:
according to EN ISO 80601-2-55. • CO2: The highest concentration of CO2 during one breathing cycle with a weight
function applied to favour values closer to the end of the cycle.
• ET typically decrease below nominal value (ETnom) when RR exceeds the RR
threshold (RRth) according to the following formula:

125
ET = ETnom   ---------- for RRth >70
RR

Effects from water vapour partial When the breathing gas flows through the sampling line, the gas temperature adapts
pressure on gas readings to the ambient temperature before reaching the gas analyser. The measurement of
all gases always shows the actual partial pressure at the current humidity level in the
gas sample. As the NOMO section removes all condensed water, no water reaches
the ISA gas analyser. However, at an ambient temperature of 37°C and a breathing
gas with a relative humidity of 95%, the gas reading is typically 6% lower than the
corresponding partial pressure after the removal of all the water.

Interfering gas and vapour effects Gas or vapour Gas level IRMA/ISA CO2
[vol%] [% of reading]

N 2 Oa 60 -b
HAL 4 -c
NEF, ISO, SEV4 5 + 8d
DES4 15 + 123
Xe (Xenon)4 80 -103
He (Helium)4 50 - 63
Metered dose inhaler propellants4 Metered dose inhaler propellants
C2H5OH Ethanol4 0.3 -1
C3H7OH Isopropanol4 0.5 -1
CH3COCH3 (Acetone)4 1.0 -1
CH4 Methane4 3 -1
CO (Carbon monoxide)5 1 -1
NO (Nitrogen monoixide)e 0.02 -1
O2 5 100 -1
a. Negligible interference, effect included in the specification “Accuracy, all conditions” above.
Art. no: 0-48-0366 Rev: g

b. Negligible interference with N2O/O2 concentrations correctly set, effect included in the specification “Accuracy, all conditions” above.
c. Interference at the indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if
measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration is typically (1-0.06) * 5.0
vol% = 4.7 vol% CO2
d. According to the EN ISO 80601-2-55:2011 standard
e. In addition to the EN ISO 80601-2-55:2011 standard.

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 Technical Data 11
DEFIGARD HD-7 User guide WLAN Standard 11.5

11.5 WLAN Standard

Modules WL1831MOD

FCC ID Z64-WL18SBMOD
IC ID 451I-WL18SBMOD

Transmission standards IEEE 802.11 b, g, n

Frequency range 2.4 GHz

Maximum power output 2.4 GHz

+17.3 dBm
(1DSSS)

11.6 Device Configuration

To modify the settings of your unit, contact your technical representative.

11.6.1 General configuration

Parameter Values Description
This option shall be activated if artefacts are detected on ECG signals
when the device is plugged into the mains. The notch filter must be
chosen according to the location.
None
Notch filter 50 Hz*
50 Hz: Europe, Africa, Middle East (except Saudi Arabia), Asia-Pacific
60 Hz
(except Japan, Taiwan and Philippines), Australia
60 Hz: The American continent (except for Chile, Argentina, Uruguay,
Paraguay, Bolivia, French Guyana).
Monitoring Sets the desired default view in monitoring.
Monitoring display
Monitoring big values Monitoring big values: No curves are displayed by default; only big
mode
6 ECG leads monitoring values.
Activating this option checks the electrode’s presence during the self-
Defibrillation pads True* test.
active detection False Shall the RFID Tag of the electrodes not be detected during
the test, the device issues an alarm.
Sets the behaviour of the HR parameter box between the following
possibilities:
Auto* Auto: The device automatically detects the HR source with predefined
Defi priorities level. ECG higher than DEFI higher than SpO2 (pulse)
ECG: I
Default HR source Defi: Always force the HR calculation on DEFI
ECG: II
ECG I: Always force the HR calculation on ECG lead I
ECG: III
ECG II: Always force the HR calculation on ECG lead II
Pleth
ECG III: Always force the HR calculation on ECG lead III
Art. no: 0-48-0366 Rev: g

SpO2: Always force the HR calculation on SpO2 (pulse).

Audio pause at the 2 minutes* When this option is activated, the device remains silent for 2 minutes
start OFF at the start, even if an alarm occurs.
The device wakes up by default weekly to perform a self-test. It is
Periodic test Daily* possible to set a daily test.
frequency Weekly Hereafter, the details of the content of the automatic and manual self-
test

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11 Technical Data
11.6 Device Configuration DEFIGARD HD-7

Parameter Values Description

This parameter specifies when the device automatically wakes up to
perform its self-test. This field must be specified in hours in a 24-hour
Time of test 12 format.
Always specify the time in HH and not in HH:MM, for example, 13
refers to 1 PM, 13:30 is not allowed.
Disable: 0h/1h/2h/3h/4h/5h/
If activated, this parameter specifies when the device will automatically
6h/7h/8h/9h/10h/11h/12h/
Time of test 2 (daily) wake up to perform its self test.
13h/14h/15h/16h/17h/18h/
Disabled: no wake-up/0 to 23h
19h/20h/21h/22h/23h
Disable: 0h/1h/2h/3h/4h/5h/
If activated, this parameter specifies when the device will automatically
6h/7h/8h/9h/10h/11h/12h/
Time of test 3 (daily) wake up to perform its self test.
13h/14h/15h/16h/17h/18h/
Disabled: no wake-up/0 to 23h
19h/20h/21h/22h/23h
Technician
0000 Sets the password that is asked for to enter the Control Panel.
password
Elevated memory Sets the password that will be asked to activate Bluetooth (Not in use
************
access password at the present)
English* German/French/
Spanish/Italian/Czech/
Danish/Estonian/Greek/
Finnish/Croatian/
Hungarian/indonesian/
Korean/Lithuanian/Latvian/
Sets of the language that the device starts with by default. Even if the
Malay/Dutch/Norwegian/
Default language language is modified during the use, the device starts again with the
Polish/Brazilian
language specified here.
Portuguese/Portuguese/
Romanian/Russian/Slovak/
Slovenian/Serbian/
Swedish/Thai/Turkish/
Ukranian/Mandarin/
Taiwanese
Low
Selection of the overall sound level applied to technical and
Alarm sound level Medium*
physiological alarms.
High
Idle automatic 30 minutes If enabled, the device automatically shuts down if no sign of activity
shutdown Disabled* (vital sign measurement) is detected within 30 minutes.
Control panel Log out from the control panel after this inactivity timeout, you need to
2 to 5 minutes
inactivity timeout re type password then).
Password maximum
None/1/2/3/4/5/6/7/8/9/10 When this limit is reached, you need to restart the device.
attempts
False
Audio OFF allowed If this option is activated, the user can switch off alarms.
True*
No confirmation
Manual defibrillation Sets the behaviour of the device while entering manual defibrillation
Confirmation needed*
mode mode.
Password protected
Art. no: 0-48-0366 Rev: g

Password to be entered entering manual defibrillation mode. Manual

Manual defibrillation
0000 defibrillation mode is password protected. The user can modify the
mode password
password.
Confirmation to True*
If enabled, the device requires a confirmation to leave AED mode.
leave AED mode False

11.6.2 Defibrillator
Parameter Values Description
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Default energy for Sets the energy level displayed by default when entering manual
12, 13, 14, 15, 20, 30, 50, 70,
adults in manual def. defibrillation mode in adult mode.
90, 100, 120, 150*, 200 joules

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Parameter Values Description

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Default energy for Sets the energy level displayed by default when entering manual
12, 13, 14, 15, 20, 30, 50*, 70,
children in manual def. defibrillation mode in child mode.
90 joules
True If this option is activated, the device remains in sync. mode after
Sync. after sync shock
False* asynchronised shock in manual defibrillation.
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Sets the energy level delivered for the first shock in AED in adult
First shock for adults 12, 13, 14, 15, 20, 30, 50, 70,
mode.
90, 100, 120, 150*, 200 joules
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Sets the energy level delivered for the second shock in AED in
Second shock for adults 12, 13, 14, 15, 20, 30, 50, 70,
adult mode.
90, 100, 120, 150, 200* joules
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Sets the energy level delivered for the third shock in AED in adult
Third shock for adults 12, 13, 14, 15, 20, 30, 50, 70,
mode.
90, 100, 120, 150, 200* joules
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Sets the energy level delivered for the first shock in AED in child
First shock for children 12, 13, 14, 15, 20, 30, 50*, 70,
mode.
90 joules
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Second shock for Sets the energy level delivered for the second shock in AED in
12, 13, 14, 15, 20, 30, 50*, 70,
children child mode.
90 joules
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
Sets the energy level delivered for the third shock in AED in child
Third shock for children 12, 13, 14, 15, 20, 30, 50*, 70,
mode.
90 joules

11.6.3 Digital signal processing

Parameter Values Description
Enables the analysis features (part of the signal analysis is done on the
signal before the device mentions the start of the analysis).
Analysis with anteriority*:
With Anteriority* In AED mode, if motion artefacts do not disturb the signal, the analysis
Without Anteriority starts in the background 10 seconds before the advice of the analysis.
Analysis
Analysis Whilst This process may result in a faster shock delivery.
Compressing Analysis without anteriority:
Standard AED analysis
Analysis Whilst Compressing:
Not yet available; if selected, Analysis with Anteriority is activated.
False Enable/disable the Analysis button in AED mode, this allows starting
Analysis key
True* an AED analysis manually.
Alarm on Vfib or False*
Enable/Disable the alarms in case of VF/VT detected.
Vtach detection True*

11.6.4 AED
Parameter Values Description
Art. no: 0-48-0366 Rev: g

Display monitoring False

If enabled, the monitoring parameters are displayed in AED mode.
parameters in AED True*
Display curve in False If enabled, ECG lead Defi, EtCO2 and SpO2 curve are displayed in AED
AED True* mode.
High
AED voice level Medium* Sets the level of voice prompts in AED mode.
Low

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11 Technical Data
11.6 Device Configuration DEFIGARD HD-7

11.6.5 CPR
Parameter Values Description
30:2*
Metronome Metronome default behaviour in adult mode.
15:2
behaviour adult This behaviour can be changed during intervention on the device.
Continuous OFF
30:2
Metronome Metronome default behaviour in child mode.
15:2*
behaviour child This behaviour can be changed during intervention on the device.
Continuous OFF
100 cpm*
Metronome rate 110 cpm Sets the frequency of the metronome.
120 cpm
High
Metronome audio
Medium* Sets the audio level of the metronome.
level
Low
cm* Sets the unit in which the chest compression depth values are
CPR depth unit
inch displayed.
1 minute
CPR cycle duration 2 minutes* Sets the duration of the CPR cycle.
3 minutes
No assistance*
CPR Feedback only
CPR during AED Metronome only Sets the type of assistance during CPR in AED mode.
CPR Feedback and
Metronome
No assistance*
CPR Feedback only
CPR during manual
Metronome only Sets the type of assistance during CPR in manual defibrillation.
defibrillation
CPR Feedback and
Metronome
Launch the manual
False*
defibrillation timer at
True
the start.

Art. no: 0-48-0366 Rev: g

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11.6.6 ECG
Parameter Values Description
0.25 mV
0.5 mV Sets the default ECG curve amplitude, If Auto is selected, the
ECG curve
1 mV displayed amplitude is automatically adapted depending on the signal
amplitude
2 mV amplitude.
Auto*
IEC
IEC Displays ECG lead colours in accordance with IEC standards
ECG lead wire
AAMI/AHA AAMI/AHA
Displays ECG lead colours in accordance with AHA standards
False*
ECG 16,7 Hz filter Not used
True
OFF
Low*
QRS sound level Sets the audio level of the QRS sound issued by the ECG.
Medium
High

11.6.7 NIBP
Parameter Values Description
Deflation rates 3, 4, 5, 6, 7, 8, 9 mmHg/s Sets the cuff deflation rate.
mmHg*
NIBP unit Sets the unit in which the NIBP values will be displayed and stored.
kpa
Automatic cycles at False* Automatic NIBP measurement cycle starts once the first measurement
start True is initiated manually.
Initial pressure for 90, 120, 150, 180*, 210,
Sets the initial cuff pressure for measurement in adult mode.
adults 240, 270 mmHg
Initial pressure for 90, 120, 150*, 180, 210,
Sets the initial cuff pressure for measurement in child mode.
children 240, 270 mmHg
Initial pressure for 50*, 70, 90 110,130, 150
Sets the initial cuff pressure for measurement in neonate mode.
neonate mmHg

11.6.8 SpO2
Parameter Values Description
SpO2 average 4, 6, 8, 10,12*,14, 16 Sets the integration time for the calculation of the displayed average
seconds value.
Normal* Sets the measurement sensitivity.
SpO2 sensitivity Adaptive Probe OFF APOD is optimised for the detection of Sensor has come off,
Detection regardless of the signal quality.
OFF
SpO2 sound level Low
Sets the audio level of the pulse sound.
Medium*
Art. no: 0-48-0366 Rev: g

High

11.6.9 EtCO2
Parameter Values Description
50*, 75, 100 mmHg
Respiration curve
8, 12,15% Sets the respiration curve amplitude to be displayed by default.
amplitude
7, 10, 14 kPa
vol%
EtCO2 unit mmHg* Sets the unit in which the EtCO2 value is displayed and stored.
kPa

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11 Technical Data
11.6 Device Configuration DEFIGARD HD-7

11.6.10 Time and date

Parameter Values Description
DD/MM/YY*, MM/DD/YY
Date format Sets the format in which the date is displayed.
YY/MM/DD
AM/PM
Time format Sets the time format.
24H*
Europe/Berlin
Europe/Paris*
Europe/London
Time zone Sets the time zone to calculate the appropriate date and time.
GMT -12 to -1
GMT 0
GMT 2 to +12

11.6.11 Event
Parameter Values Description
Enter an event name (for example, a medication).
This event can be selected on the device in the events list during
Event (from 1 to 20) Event (1 to 20)
intervention. Once selected, it is stored in the memory and flagged in
the intervention report (20 customisable fields).

11.6.12 Email configuration

Parameter Values Description
Any hostname of the SMTP provider
Email server -
(for example: smtp.myinternetprovider.com)
Email address The email from which the Emails are going to be sent (for example:
-
source mymail@myinternetprovider.com).
The port that is used to communicate with the SMTP server
Server port -
(for example: 25, 465, 587).
Enables TLS/SSL encryption for communication with the SMTP
False*
TLS Server. This setting must be set according to the SMTP Server
True
requirements.
Authentication False* Enables authentication for communication with the SMTP Server. This
required True setting must be set according to SMTP Server requirements.
Login - The login used for the SMTP server authentication.
Password - The password used for the SMTP server authentication.

11.6.13 Email addresses

Parameter Values Description
Email address (from The Email address must be correctly entered. For example,
-
1 to 30) user@myinternetprovider.com.
Art. no: 0-48-0366 Rev: g

This text is displayed on the device for a better recognition of the

Alias (from 1 to 30) -
recipient. For example, Dr USER.

11.6.14 Transmission
Parameter Values Description
If this option is activated, the device automatically sends the media,
using the media selected in the Transmission media during the
Automatic Long True
intervention, to the address specified for the SEMA Server.
ECG transmission False*
There are no previews of the resting ECG on the device; after the
acquisition, it is automatically sent.

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DEFIGARD HD-7 User guide Device Configuration 11.6

Parameter Values Description

The device is capable of transmitting its memory automatically after an
intervention using the media selected in Transmission media by
automatic wake-up, with the following scenario:
Automatic Never (OFF)
At device power OFF
intervention data 10 minutes after the device has been shut down (After the device
OFF*
transmission powers OFF).
After a successful intervention, data transmission:
The device also automatically transmits the latest self-test report
The device synchronises its clock with the server.
The selected media is always selected by default at the manual start
Transmission media Wi-Fi*
of the device.
during intervention USB/Ethernet
The user can always change this media during the intervention.
Transmission media The selected media will always be selected by default during automatic
Wi-Fi*
by automatic wake wake up of the device (automatic intervention data transmission,
USB/Ethernet
up automatic self-test results transmission).

11.6.15 Ethernet
Parameter Values Description

Sets the IP address to be used to test the connectivity of the device

Ethernet ping serve 8.8.8.8 over the Ethernet. It is recommended to use a common DNS server (for
example, 8.8.8.8) or the public SEMA Server IP address.

11.6.16 Print
Parameter Values Description
Infinite*
Sets the duration of curves printout when the Print button is pressed.
Realtime print 10 seconds
duration 20 seconds
Note that only the 3 first curves displayed are printed out.
30 seconds

Printout anteriority 8 sec*

Sets the anteriority duration for the capture of curves in a printout.
duration No anteriority
Autoprint On shock True* If enabled, the printer automatically prints the curves shown on the
delivery False screen during shock delivery.
Autoprint On VF/VT True If enabled, the printer automatically prints the curves shown on the
or asystole alarm False* screen on a VF/VT or asystole alarm.
Autoprint On out-of - True If enabled, the printer automatically prints the curves shown on the
range alarm False* screen of an out-of-range alarm.
Autoprint a True
If enabled, the printer automatically prints the screenshot.
screenshot False*
Autoprint On a
True
manual event If enabled, the printer automatically prints the curves on the screen if
False*
Art. no: 0-48-0366 Rev: g

registration an event is manually registered.

Autoprint self-test True*
If enabled, the printer automatically prints a report with self-test results.
results False

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11 Technical Data
11.6 Device Configuration DEFIGARD HD-7

11.6.17 Wi-Fi

• Three different networks can be pre-configured in the device.

• The device is able to connect itself to a hidden SSID.

Parameter Values Description

SSID - SSID of the Wi-Fi Network that shall be used for data transmission.

WEP
WPA
WPA2* Type of encryption from the Wi-Fi Network to be used for data
Encryption type
WPA-EAP transmission.
WPA2-EAP
None

Security key - Security key of the Wi-Fi Network to be used for data transmission.

Wi-Fi Login - Login used for EAP authentication.

Wi-Fi Password - Password used for EAP authentication.

Sets the IP address to be used to test the connectivity of the device

Wi-Fi ping server - over Wi-Fi. It is recommended to use a common DNS server (for
example, 8.8.8.8), or the public SEMA Server IP address.

11.6.18 SEMA
Parameter Values Description
Sets the IP address or the hostname of the SEMA Server
Should the device be able to send data to SEMA over the Internet, the
SEMA server - public IP address or hostname must be specified and not the private.
For example, 188.165.287.137
(public IP) and not 192.168.200.32 (private IP).

Sets the port with which the SEMA Server is reachable. This port might
be different whether the device tries to connect with or without SSL
SEMA server port 8181
encryption.
For example, By default, 8080 is used for HTTP and 8181 for HTTPS.
Sets SSL encryption. It is recommended to activate this option to
SEMA SSL False
secure the communication, especially if transmission is over the
encryption True*
Internet.
Sets the device login to SEMA. To be able to transmit data to SEMA,
SEMA login - a login and password must be specified for each device The login/
password can be the same for all devices.
Sets the device password to SEMA. To be able to transmit data to
SEMA password - SEMA, a login and password must be specified for each device The
Art. no: 0-48-0366 Rev: g

login/password can be the same for all devices.

Sets Technician ID. This field is only necessary if Multi-tenancy is used
SEMA Attending
- in the SEMA in order to split recordings. Typically, the Attending name
name
is a specific login in the SEMA Server.

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 Technical Data 11
DEFIGARD HD-7 User guide Electromagnetic Interferences 11.7

11.6.19 SCHILLER Update Server (SUS)

Parameter Values Description
Sets either the IP address or the hostname of the SUS Server.
If the device is able to update itself over the Internet, the public IP
SUS server - address or hostname must be specified and not the private address,
for example, 188.165.287.137
(public IP) and not 192.168.200.32 (private IP).

Sets the port with which the SUS Server is accessible. This port might
be different whether the device tries to connect with or without SSL
SUS server port 8181
encryption.
For example, By default, 8080 is used for HTTP and 8181 for HTTPS.
Sets SSL encryption. It is recommended to activate this option to
SUS SSL False
secure the communication, especially if transmission is completed
encryption True*
over the Internet.
Sets the device login to the SUS. To be able to retrieve data from the
SUS login - SUS, a login and password must be specified for each device The
login/password can be the same for all devices.
Sets the device password to the SUS. To be able to retrieve data from
SUS password - the SUS, a login and password must be specified for each device. The
login/password can be the same for all devices.

11.6.20 Maintenance
Parameter Values Description

Sets the password that will be asked to validate the maintenance of the
Service device.
maintenance ********** – Maintenance Frequency: 1 year/2 years/3 years/4 years/5 years/
password
6 years/7 years/8 years/9 years/10 years.

11.7 Electromagnetic Interferences

The DEFIGARD HD-7 is intended to be used in the electromagnetic environments
listed in the following tables. The user of the DEFIGARD HD-7 has to ensure that the
device is operated in an adequate environment.

11.7.1 Electromagnetic emissions

Compliance with the
Emission measurement Electromagnetic environment explanations
regulations
DEFIGARD HD-7 only uses HF energy for internal
HF emissions
Group 1 functions. Therefore, HF emissions are very low and
CISPR 11
interferences with electronic devices nearby are unlikely.
Art. no: 0-48-0366 Rev: g

HF emissions
Class B
CISPR 11 DEFIGARD HD-7 is suitable for use in all establishments,
including domestic establishments and those directly
Harmonics IEC 61000-3-2 Class A
connected to the public low-voltage power supply network
Voltage fluctuations that supplies buildings used for domestic purposes.
Compliant
IEC 61000-3-3

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11 Technical Data
11.7 Electromagnetic Interferences DEFIGARD HD-7

11.7.2 Electromagnetic immunity

Interference IEC 60601 test level Conformity Electromagnetic environment
testing level explanations
Floors should be made of wood, concrete or
Electrostatic
± 8 kV contact IEC 60601-1 ceramic tiles. If floors are covered with synthetic
discharge
± 15 kV air conformity material, relative humidity should be at least
IEC 61000-4-2
30%.
Electrical fast
± 2 kV for power supply lines IEC 60601-1 Mains power quality should be that of a typical
transient/burst
± 1 kV for input/output lines conformity commercial or hospital environment.
IEC 61000-4-4
Surge ± 1 kV between conductors IEC 60601-1 Mains power quality should be that of a typical
IEC 61000-4-5 ± 2 kV conductor-earth conformity commercial or hospital environment.
> 95% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180° 225°,
270° and 315°
Mains power quality should be that of a typical
Voltage dips, short
commercial and/or hospital environment. If the
interruptions and > 95% UT; 1 cycle
user of the DEFIGARD HD-7 is reliant on
voltage variations on IEC 60601-1
permanent operation even in the case of a power
power supply input 30% UT; 25 (50 Hz)/30 (60 Hz) conformity
failure, it is suggested connecting the
lines cycles h)
DEFIGARD HD-7 to an uninterruptible power
IEC 61000-4-11 Single phase: at 0°
supply or use it with a battery.
95% UT; 250(50 Hz) 300 (60 Hz)
cycle
Power frequency
Power frequency magnetic fields should be that
(50/60 Hz) magnetic 30 A/m 100 A/m
of a typical commercial or hospital environment.
field 131
Note that UT indicates the AC voltage of the mains before the test level.

Art. no: 0-48-0366 Rev: g

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Interference testing IEC 60601 test level Conformity Electromagnetic environment explanations
level
Recommended minimum distances
Portable and mobile HF telecommunication devices
must keep the recommended minimum distance (d)
from the DEFIGARD HD-7 and all its components,
including cables. The recommended minimum
distance is calculated based on the transmitter's
frequency.

3 Vrms outside ISM band

Conducted RF 6 Vrms in the ISM & amateur [V1] = 10 Vrms
3.5
IEC 61000-4-6 radio band [V1] = 10 Vrms d = --------  P
V1
150 kHz to 80 MHz

[E1] = 20 V/m 3.5

d = -------  P for 80 MHz to 800 MHz
80 to 2700 E1
Radiated HF
20 V/m 80 MHz to 2.7 GHz MHz
IEC 61000-4-3
7
d = ------  P for 800 MHz to 2.7 GHz
E1

Refer to
section
11.7.3 Immu
Proximity fields from
Refer to section nity to
RF wireless
11.7.3 Immunity to proximity proximity The recommended separation distance for this tested
communications
fields from RF wireless fields from frequency is 0.3 of a meter.
equipment IEC 61000-
communications equipment RF wireless
4-3
communicati
ons
equipment

Where P is the maximum power in watts and d is the

recommended separation distance in meters.

Field strengths from fixed transmitters, as determined

by an electromagnetic sitea survey, should be less
than the complianceb levels (V1 and E1).

Interference may occur in the vicinity of equipment

marked with:
Art. no: 0-48-0366 Rev: g

Non-ionising electromagnetic radiation

Note 1: For 80 to 800 MHz, the higher frequency range applies.

Note 2: These guidelines might not always be applicable. Electromagnetic radiation is influenced by absorption and reflection on structures,
objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radio,
AM and FM radio broadcasts and TV broadcasts, cannot be predicted as accurate. To access the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
b. Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than [E1] V/m.

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11 Technical Data
11.7 Electromagnetic Interferences DEFIGARD HD-7

11.7.3 Immunity to proximity fields from RF wireless communications

equipment

Test Maximum Distance

frequency Banda Service
Modulation
power P d
Immunity
[MHz] level [V/m]
[MHz] [W] [m]
Pulse
Various radio services
385 380-390
(TETRA 400) modulationb 1.8 0.3 27
18 Hz

- Walkie-talkies (FRS) FM c
450 430-470 - Rescue service, police, fire ± 5 kHz 2 0.3 28
brigade, servicing (GMRS) ± 1 kHz sine

710 Pulse
745 704-787 LTE band 13/17 modulation 0.2 0.3 9
780 217 Hz

- GSM800/900
810 - LTE band 5 Pulse
870 800-960 - Radiotelephone modulation 2 0.3 28
930 (microcellular) CT1+, CT2, 18 Hz
CT3

- GSM1800/1900
1720 Pulse
- DECT (radio telephone)
1845 1700-1990 modulation 2 0.3 28
- LTE Band 1/3/4/25
1970 217 Hz
- UMTS

- Bluetooth, WLAN 802.11b/

g/n
Pulse
- LTE Band 7
2450 2400-2570 modulation 2 0.3 28
- RFID 2450 (active and
217 Hz
passive transponders and
reading devices)

5240 Pulse
5500 5100-5800 WLAN 802.11a/n modulation 0.2 0.3 9
5785 217 Hz

a. For some services, only the uplink frequencies are included.

b. The carrier shall be modulated using a 50% duty cycle square wave signal.
c. As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would
be the worst case.

Art. no: 0-48-0366 Rev: g

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 Appendix 12
DEFIGARD HD-7 User guide Accessories and Disposables 12.1

12 Appendix
12.1 Accessories and Disposables
 Always use SCHILLER replacement parts and disposables or products
approved by SCHILLER. Failure to do so may endanger essential performance
and life or invalidate the warranty.

Your local representative stocks all the disposables and accessories for the
DEFIGARD HD-7. A full list of all SCHILLER representatives can be found on the
SCHILLER website (www.schiller.ch).

12.2 Accessories DEFIGARD HD-7

Article no. Article description
ECG
0-05-0071 4 leads ECG cable clip type – angled connector, 1,05 meters
ECG electrodes pouch: SCHILLER recommends using ECG electrodes with liquid gel (for example,
-
Ambu BlueSensor or Medico electrodes MLGLT-03).
NIBP
0-04-0012 Cuff for neonatal soft, 4 cm (Arm circumference 6 to 12 cm)
0-04-0016 Cuff for Child, 8 cm (Arm circumference 11 to 22 cm)
0-04-0014 Cuff for Child, 11 cm (Arm circumference 16 to 28 cm)
0-04-0013 Cuff for Adult, 13 cm (Arm circumference 26 to 33 cm)
0-04-0017 Cuff for Adult, 15 cm (Arm circumference 33 to 41 cm)
0-04-0015 Cuff for Adult, 19 cm (Arm circumference 39 to 55 cm)
0-87-0006 Hose assembly NIBP, 2 meters
SpO2 Masimo

0-05-0084 RD EMS Patient cable

0-05-0085 RD to M-LNC Adapter cable
0-05-0090 RD Hospital Patient cable
0-13-0063 RD SET DCI, Adult Reusable sensor
0-13-0064 RD SET DCI, Paediatric Reusable sensor
Art. no: 0-48-0366 Rev: g

0-13-0065 RD SET DBI, Adult Reusable Soft Boot sensor

SpO2 Nellcor

0.13.0068 Nellcor Reusable SpO2 adult Sensors

0-13-0062 Nellcor SpO2 child Sensors

0-05-0069 Nellcor Adapting cable

CO2 ISA

??? Always use Masimo sampling line Nomoline Low Humidity LH or Hight Humidity HH

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12 Appendix
12.2 Accessories DEFIGARD HD-7 DEFIGARD HD-7

Article no. Article description

Defibrillation
2.155061 1 pair disposable adhesive defibrillation electrode pads for adults, 80 cm²
2.155067 1 pair of disposable adhesive defibrillation pads for children, 42 cm²
0-21-0040 1 pair disposable adhesive defibrillation electrode pads for adults,80 cm² pre-connected with RFID
0-05-0064 Pads adapter connector BigSPC-P to connector type SPC-D
1-130-3000 Paddles
6-34-0005 Spoon electrodes, 67 x 88 mm - 54 cm² (set of 2 pcs)
6-34-0006 Spoon electrodes, round 64 mm, 32 cm² (set of 2 pcs)
6-34-0011 Spoon electrodes, round 28 mm - 6 cm² (set of 2 pcs)
6-34-0012 Spoon electrodes, round 45 mm -16 cm² (set of 2 pcs)
6-34-0013 Spoon electrodes, oval 43 x 27 mm - 9cm² (set of 2 pcs)
W1410013 Connection cable for spoon electrodes
1-130-3001 Adapter for connection cable for spoon electrodes
35131 Defibrillation gel
CPR feedback
2.100870 ARGUS LifePoint (CPR feedback sensor)
2.100519 Adhesive pad set of 5 pcs
General
accessories
2.157059 Thermal paper roll 80 mm
U50030 Potential equalisation cable
0-80-0040 Accessories bag
2-19-0014 Trolley
72285 AC Power cord cable UK
51644 AC Power cord cable US
U32010 AC Power cord cable EU
4-15-0052 AC Power cord cable ZH
4-15-0065 AC Power cord cable BR Art. no: 0-48-0366 Rev: g

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 Appendix 12
DEFIGARD HD-7 User guide Literature 12.3

12.3 Literature
European Resuscitation Council Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
(2015) Care

American Heart Association (2015) Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
Care

Cansell A. (2000) Wirksamkeit und Sicherheit neuer Impulskurvenformen bei transthorakaler

Defibrillation – Biphasische Impulskurvenformen – Notfall- & Rettungsmedizin,
Springer-Verlag 3: 458 – 474.

Clinical experience with a low-ener- Jean-Philippe Didon, Guy Fontaine, Roger D. White, Irena Jekova, Johann-Jakob
gy pulsed biphasic waveform in out- Schmid, Albert Cansell; Clinical experience with a low-energy pulsed biphasic
of-hospital cardiac arrest waveform in out-of-hospital cardiac arrest, Resuscitation (2008) 76, pp 350—353.

12.4 Glossary
AED Automated External Defibrillator

BLS Basic Life Support (artificial respiration and cardiac massage)

CPR is frequently used synonymously

CPR Cardiopulmonary Resuscitation

VT Ventricular Tachycardia

VF Ventricular Fibrillation
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12 Appendix
12.4 Glossary DEFIGARD HD-7

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 Index 13
DEFIGARD HD-7 User guide

13 Index
A Lifed Item Replacement ................. 131
Maintenance interval ........................... 118
Accessories and disposables .............. 133
Maintenance interval for the battery .... 124
Activating the audio alarm ..................... 44
Alarm indicators ..................................... 44 Manual defibrillation .............................. 82
Manual defibrillation using pads ............ 89
Alarm messages .................................... 43

B N
Battery NIBP Menu ............................................ 67
NIBP softkey ......................................... 66
Battery life ...................................... 136
Low battery ....................................... 33
Battery disposal ................................... 124 O
Battery type ......................................... 136
Operating elements ............................... 27
Biocompatibility ..................................... 25 Operational readiness ........................... 33

C P
Charge control and monitoring ............ 140
Pacemaker
Charging time ...................................... 139 Fixed-rate mode (Fix) ..................... 102
Cleaning .................................. 125, 129
Pacemaker patients .............................. 50
Cycle time shock – shock .................... 140
Patient resistance ................................ 140
Physiological alarms ............................. 44
D
Danger of electric shock ........................ 17 S
Danger of explosion .............................. 30
Safety discharge ................................. 141
Default energy settings ........................ 139 Self ...................................................... 120
Defibrillation - procedure ....................... 97
Semiautomatic defibrillation .................. 95
Defibrillation pulse ............................... 138
Shock delivery ..................................... 141
Demand mode ..................................... 103 SpO2 error messages ........................... 59
SpO2 Menu ........................................... 59
E SPO2 monitoring ................................... 54
Step 2 Analysis ..................................... 97
ECG error messages ............................. 52
Step 3 shock delivery ............................ 97
ECG Menu ............................................. 54
ECG, quick diagnosis ............................ 48 Step 4 Cardiopulmonary resuscitation .. 98
Suppressing an alarm sound ................ 44
Error Detection .................................... 133
Symbols on the device .......................... 22
EtCO2
Symbols used on the electrode package 24
Sensor LED ...................................... 70
Event marks .......................................... 89 Synchronised defibrillation .................... 92

F T
Technical alarms ................................... 44
Functional test
Auto Test ........................................ 120
Battery charging status ................... 119 V
Button test in SAED automatic Voice support ........................................ 96
operation ........................................ 119
Charging condenser (monthly) ....... 120
Art. no: 0-48-0366 Rev: g

Visual inspection of the device and W

accessories .................................... 119 Warranty ................................................ 20

I
Internal defibrillation .............................. 92

L
LEDs ...................................................... 28

M
Maintenance

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13 Index
DEFIGARD HD-7

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 Appendix - Symbols 14

14 Appendix - Symbols
This appendix lists all general symbols that may be present on the
device, label and accessories. Not all of those symbols are necessarily
present on your device.
This appendix has its own article number, which is independent of
the user guides article number.

Identification of the manufacturer

Identification of the manufacturing date

Identification of the distributor

Identification of the importer

Medical device

Serial number

Reference number

Batch code

Global Trade Item Number

Catalogue number

Quantity
Art. no:0-48-0454 Rev. a: version 5

UDI: unique device identification as QR code machine readable and

human readable as number, e.g., (01) 0 7613365 00210 2 (21)xxxx.xxxxxx

Number of pieces in the packaging

Authorised European representative

Authorised Switzerland representative

14 Appendix - Symbols

Notified body (e.g., marking notified body GMED)

UKCA marking (UK Conformity Assessed)

CE marking, affirms its conformity with European legislations (direc-

tive/regulation

Regulatory Compliance Mark for the Australian standards

The device is recyclable

Symbol for the recognition of electrical and electronic equipment.

Device must not be disposed of in the household waste.

Symbol for the recognition of a battery. Battery must not be dis-

posed of in the household waste.

The packaging is made in low density polyethylene and can be

recycled.

Federal law (USA) restricts this device to sale by or on the order of a

physician

Non-ionising electromagnetic radiation. To indicate that the device

contains a Radio Frequency (RF) transmitter to transmit data (e.g.,
Bluetooth or Wi-Fi)

Contains a Bluetooth module

Do not reuse

Latex-free

Use-by date (expiry date of battery, electrodes or other consuma-

Art. no: 2.520164 Rev. a

bles)

Temperature range for storage or transport, respectively

Pressure range for storage or transport, respectively

Humidity range for storage or transport, respectively

 Appendix - Symbols 14

Consult instruction for use (indicates the need for the user to con-
sult the instructions for use)

x Use within X days after opening (electrodes or other consumables)

Keep dry (store in a dry location)

Keep away from sunlight (protect from direct sunlight)

Fragile, handle with care

Transport upwards (this way up)

Do not use hooks

EIP = electronic information product (does not contain any toxic and
hazardous substances or elements above the maximum concentra-
tion values (product can be recycled and re-used).
Art. no:0-48-0454 Rev. a: version 5
14 Appendix - Symbols

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Art. no: 2.520164 Rev. a