Patient Monitor

Deluxe-70

User Manual
(Version 1.2)

Heal Force Bio-Meditech Holdings Group

 User Manual for Patient Monitor

This Manual is written and compiled in accordance with the IEC 60601-1（Medical electrical equipment Part1: General
requirements for safety）, and MDD 93/42/EEC. It complies with both international and enterprise standards and is also
approved by State Technological Supervision Bureau. The Manual is written for the current Deluxe-70 Patient Monitor.
In case of modifications and software upgrades, you will be advised in due time with a Modification Notice.
The Manual describes, in accordance with the Deluxe-70 Patient Monitor’s features and requirements, main structure,
functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and
storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters
for details.

The Manual is published in English and we have the ultimate right to explain the Manual. No part of this manual may
be photocopied, reproduced or translated into another language without the prior written consent. We reserve the right
to improve and amend it at any time without prior notice. Amendments will however be published in a new edition of
this manual.

All rights reserved.

Marks in the Manual:

0 Warning: must be followed to avoid endangering the operator and the patient.
Note: contains some important information and tips about operations and application.
 Attention: must be followed to avoid causing damage to the monitor.

3502-3560001

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 User Manual for Patient Monitor

Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following very carefully before
using this equipment.
These instructions describe the operating procedures to be followed strictly. Failure to follow
these instructions can cause monitoring abnormality, equipment damage and personal injury.
The manufacturer is NOT responsible for the safety, reliability and performance issues and any
monitoring abnormality, personal injury and equipment damage due to user’s negligence of the
operation instructions. The manufacturer’s warranty service does not cover such faults.
0 WARNING-PACEMAKER PATIENTS. Rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not
rely entirely upon rate meter ALARMS. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse rejection
capability of this instrument.

0 Monitoring a single person at a time.

0 The monitor is defibrillator proof. Verify that the accessories can function safely
and normally and the monitor is grounded properly before conducting
defibrillation.

0 Disconnect the monitor and sensors before MRI scanning. Use during MRI could
cause burns or adversely affect the MRI image or the monitor’s accuracy.

0 If you have any doubt to the grounding layout and its performance, you must use
the built-in battery to power the monitor.

0 All combinations of equipment must be in compliance with standard of IEC 60601-1-1 for
medical and electric system requirements.

0 Check SpO 2 probe application site periodically (every 30 minutes) to determine

circulation, positioning and skin sensitivity.

0 The SpO 2 measurement of this monitor may not work for all testees. If stable
readings cannot be obtained at any time, discontinue using.

0 Do not immerse the monitor or its accessories in liquid to clean.

0 Do not use accessories other than those provided/recommended by the

manufacturer.

0 Each time the monitor is used, check the alarm limits to ensure that they are
appropriate for the patient being monitored.

0 The monitor is intended only as an adjunct in patient assessment. It must be used

in conjunction with clinical signs and symptoms.

0 When taking the measure of a pediatric or neonate’s (less than 10 years old) blood pressure, do
NOT operate in the adult mode. The high inflation pressure may cause lesion or even body
putrescence.

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0 The monitor is prohibited from applying to those who have severe hemorrhagic tendency or
who are with sickle cell disease for they may develop partial bleeding when this monitor is used
to take the blood pressure measurement.

0 DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or
intubations or skin lesion area, otherwise, damages may be caused to the limb.

0 Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with
microcirculatory problem. It is recommended that the sensor should NOT be applied to the
same place for over two hours, change the measuring site periodically if necessary.
0 SpO2 measuring position must be examined more carefully for some special patient. Do NOT
install the SpO2 sensor on the finger with edema or vulnerable tissue.

0 To prevent the risk of the short circuit and to ensure the ECG signal quality, the equipment
must be properly grounded.

0 Although biocompatibility tests have been performed on all the applied parts, some exceptional
allergic patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.

0 All the connecting cables and rubber tubes of the applying parts should be kept away from the
patient’ s cervix to prevent any possible suffocation of the patient.

0 All the parts of the monitor should NOT be replaced at will. If necessary, please use the
components provided by the manufacturer or those that are of the same model and standards as
the accessories along with the monitor which are provided by the same factory, otherwise,
negative effects concerning safety and biocompatibility etc. may be caused.

0 DO NOT stare at the infrared light of SpO2 sensor when switch it on, for the infrared may do
harm to the eye.

0 If the monitor falls off accidentally, please do NOT operate it before its safety and technical
indexes have been tested minutely and positive testing results obtained.
0 It is recommended to take the blood pressure measurement manually. The automatic or
continuous mode should be used at the presence of a doctor/nurse.

0 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2 cannula
kits and on-airway adapters may compromise functionality and system performance leading
to a user or patient hazard. Performance is not guaranteed if an item labeled as single patient
use is reused.

0 Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT use if it
appears to have been damaged. Refer servicing to qualified service personnel.

0 Electrical Shock Hazard; No user serviceable parts inside the CO2 Sensor.
0 After the life cycle of the Sidestream CO2 Sensor and its accessories has been met, disposal
should be accomplished following national and/or local requirements.

0 Please peruse the relative content about the clinical restrictions and contraindication.

0 When disposing of the monitor and its accessories, the local law should be followed.

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Table of Contents
CHAPTER 1 OVERVIEW .................................................................................................................1 
1.1 FEATURES ........................................................................................................................................................... 1 
1.2 PRODUCT NAME AND MODEL ............................................................................................................................. 2 
1.3 APPLICATIONS AND SCOPE .................................................................................................................................. 2 
1.4 OPERATING ENVIRONMENT ................................................................................................................................ 2 
1.5 IMPACT ON ENVIRONMENT AND RESOURCES...................................................................................................... 2 
1.6 SAFETY ............................................................................................................................................................... 2 
CHAPTER 2 WORKING THEORIES OF THE MAIN UNIT .......................................................4 
2.1 OVERALL STRUCTURE AND WORKING THEORIES............................................................................................... 4 
2.2 COMPOSITION ..................................................................................................................................................... 4 
CHAPTER 3 INSTALLATION AND CONNECTION ....................................................................6 
3.1 INTRODUCTION TO PANELS ................................................................................................................................. 6 
3.1.1 Front Panel .................................................................................................................................................. 6 
3.1.2 Left and Right Panel ................................................................................................................................... 8 
3.1.3 Rear Panel ................................................................................................................................................... 9 
3.2 INSTALLATION .................................................................................................................................................. 10 
3.2.1 Opening the Box and Check ..................................................................................................................... 10 
3.2.2 Power Supply ............................................................................................................................................ 10 
3.2.3 Starting the Monitor .................................................................................................................................. 10 
3.3 CONNECTION .................................................................................................................................................... 11 
3.3.1 ECG Connection ....................................................................................................................................... 11 
3.3.2 Blood Pressure Cuff Connection............................................................................................................... 13 
3.3.3 To connect the SpO2.................................................................................................................................. 15 
3.3.4 Printer connection ..................................................................................................................................... 18 
3.3.5 Loading printing paper.............................................................................................................................. 18 
3.3.6 BATTERY INSTALLATION ................................................................................................................................ 19 
3.3.7 Handle Installation .................................................................................................................................... 19 
CHAPTER 4 MONITORING SCREEN .........................................................................................20 
4.1 DATE AND TIME SETUP ..................................................................................................................................... 20 
4.2 MAIN SCREEN................................................................................................................................................... 21 
4.3 DISPLAY 2 SCREEN ........................................................................................................................................... 24 
4.3.1 Observing Screen ...................................................................................................................................... 24 
4.3.2 NIBP screen .............................................................................................................................................. 25 
4.3.3 Seven ECG Waveforms on the Same Screen ............................................................................................ 26 
4.3.4 Five Channels Real-time Waveforms and Trends on the Same Screen..................................................... 27 
4.3.5 Parameter screen ....................................................................................................................................... 28 
4.4 FREEZE AND S-T ANALYSIS SCREEN................................................................................................................. 29 
4.4.1 Screen Description .................................................................................................................................... 29 
4.4.2 How to Analyze the S-T Segment on ECG Waveform ............................................................................. 30 
CHAPTER 5 CO2 MONITORING ..................................................................................................31 
5.1 CO2 PARAMETER SETTINGS ............................................................................................................................. 31 
5.2 CO2 SENSOR CONNECTION ............................................................................................................................... 32 

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5.2.1 Sidestream CO2 Sensor Connection.......................................................................................................... 33 

5.2.2 Mainstream CO2 Sensor Connection ........................................................................................................ 34 
5.3 CO2 MONITORING SCREEN ............................................................................................................................... 37 
5.4 CO2 GRAPHIC TREND ....................................................................................................................................... 38 
CHAPTER 6 OPERATING INSTRUCTIONS FOR SYSTEM MENU ......................................39 
6.1 SYSTEM MENU SCREEN .................................................................................................................................... 39 
6.1.1 How to Select the Menu Item ................................................................................................................... 39 
6.2 SPO2 DATA LIST SCREEN .................................................................................................................................. 40 
6.2.1 Screen Description .................................................................................................................................... 40 
6.2.2 Operating Instructions............................................................................................................................... 40 
6.3 NIBP DATA LIST SCREEN ................................................................................................................................. 40 
6.3.1 Screen Description .................................................................................................................................... 40 
6.3.2 Operating Instructions............................................................................................................................... 40 
6.4 GRAPHIC TREND SCREEN ................................................................................................................................. 41 
6.4.1 How to View the Graphic Trend ............................................................................................................... 41 
6.4.2 Operation Instructions............................................................................................................................... 43 
6.5 RECALL SCREEN ............................................................................................................................................... 43 
6.5.1 Operation Instructions............................................................................................................................... 44 
6.6 ARRHYTHMIA SCREEN ...................................................................................................................................... 45 
6.6.1 Operation Instructions............................................................................................................................... 45 
6.7 SYSTEM SETUP SCREEN .................................................................................................................................... 46 
6.7.1 How to Select the System Setup Item ....................................................................................................... 46 
6.7.2 Parameter Settings .................................................................................................................................... 46 
6.8 COLOR SETTINGS.............................................................................................................................................. 51 
6.8.1 How to Change the Parameter Color ........................................................................................................ 51 
6.9 FILE MANAGEMENT SCREEN ............................................................................................................................ 51 
6.9.1 How to Add a New Patient........................................................................................................................ 51 
6.10 OXYCRG SCREEN ........................................................................................................................................... 52 
6.10.1 Operation Instructions............................................................................................................................. 52 
6.11 EVENT LIST SCREEN ....................................................................................................................................... 52 
6.11.1 Screen Description .................................................................................................................................. 52 
6.11.2 Operating Instructions ............................................................................................................................. 52 
6.12 MC CALCULATOR ........................................................................................................................................... 53 
6.12.1 Medicine Dosage Calculator ................................................................................................................... 53 
6.13 TOURNIQUET FUNCTION ................................................................................................................................. 54 
6.13.1 Operation Instructions............................................................................................................................. 55 
CHAPTER 7 ALARM .......................................................................................................................56 
7.1 ALARM PRIORITY ............................................................................................................................................. 56 
7.2 ALARM MODES ................................................................................................................................................. 57 
7.3 ALARM SILENCE ............................................................................................................................................... 57 
7.4 ALARM SETTING ............................................................................................................................................... 58 
7.5 VERIFY ADJUSTABLE ALARM FUNCTION .......................................................................................................... 58 
CHAPTER 8 TECHNICAL SPECIFICATIONS ...........................................................................59 
8.1 ECG MONITORING ........................................................................................................................................... 59 
8.2 RESP MONITORING .......................................................................................................................................... 60 
8.3 TEMP MONITORING ......................................................................................................................................... 60 

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8.4 NIBP MONITORING .......................................................................................................................................... 60 

8.5 SPO2 MONITORING ........................................................................................................................................... 61 
8.6 PULSE RATE MONITORING................................................................................................................................ 61 
8.7 CO2 MONITORING ............................................................................................................................................ 61 
8.8 DATA RECORDING............................................................................................................................................. 62 
8.9 OTHER TECHNICAL SPECIFICATIONS ................................................................................................................ 62 
8.10 CLASSIFICATION ............................................................................................................................................. 62 
8.11 GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC COMPATIBILITY .............................. 63 
CHAPTER 9 MONITORING PARAMETER ................................................................................67 
9.1 ECG MONITORING ........................................................................................................................................... 67 
9.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value .......................................................... 67 
9.1.2 Factors affecting ECG signal .................................................................................................................... 67 
9.2 RESPIRATION MONITORING .............................................................................................................................. 68 
9.2.1 Measuring Principle .................................................................................................................................. 68 
9.2.2 Factors affecting respiration monitoring ................................................................................................... 68 
9.3 SPO2 MONITORING ........................................................................................................................................... 68 
9.3.1 Measuring Principle .................................................................................................................................. 68 
9.3.2 SpO2 Measurement Restrictions (interference reason) ............................................................................. 68 
9.3.3 Low SpO2 measuring value caused by pathology reason ......................................................................... 69 
9.3.4 Clinical Limitations .................................................................................................................................. 69 
9.3.5 Points to be noted in SpO2 and Pulse Measuring ...................................................................................... 69 
9.4 TEMPERATURE MONITORING ............................................................................................................................ 70 
9.5 CO2 MONITORING ............................................................................................................................................ 70 
9.5.1 Measuring Principle .................................................................................................................................. 70 
9.5.2 Mainstream vs. Sidestream Sampling ....................................................................................................... 70 
9.6 NIBP MONITORING .......................................................................................................................................... 71 
9.6.1 Measuring Principle .................................................................................................................................. 71 
9.6.2 Factors affecting NIBP measuring ............................................................................................................ 72 
9.6.3 Clinical Limitations .................................................................................................................................. 72 
CHAPTER 10 PACKAGING AND ACCESSORIES .....................................................................74 
10.1 PACKAGING .................................................................................................................................................... 74 
10.2 ACCESSORIES.................................................................................................................................................. 74 
CHAPTER 11 TROUBLESHOOTING ...........................................................................................75 
11.1 NO DISPLAY ON THE SCREEN .......................................................................................................................... 75 
11.2 EXCESSIVE ECG SIGNAL INTERFERENCE OR TOO THICK BASELINE .............................................................. 75 
11.3 NO BLOOD PRESSURE AND PULSE OXYGEN MEASURES................................................................................. 75 
11.4 SYSTEM ALARM.............................................................................................................................................. 75 
CHAPTER 12 MAINTENANCE AND SERVICE .........................................................................76 
12.1 TECHNICAL MAINTENANCES .......................................................................................................................... 76 
12.1.1 Daily Examination .................................................................................................................................. 76 
12.1.2 Routine Maintenance .............................................................................................................................. 76 
12.1.3 Battery Maintenance ............................................................................................................................... 76 
12.2 CLEANING, STERILIZATION AND DISINFECTION.............................................................................................. 77 
12.3 CLEANING, STERILIZATION AND DISINFECTION OF ACCESSORIES .................................................................. 78 
12.4 STORAGE ........................................................................................................................................................ 78 

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12.5 TRANSPORTATION ........................................................................................................................................... 78 

CHAPTER 13 APPENDIX ...............................................................................................................79 
13.1 ALARM INFORMATION .................................................................................................................................... 79 
13.2 DEFAULT ALARMING VALUES AND SETUP RANGE .......................................................................................... 80 
13.3 ABBREVIATION OF ARRHYTHMIA ................................................................................................................... 82 
13.4 STATUS/ERROR DURING NIBP MONITORING .................................................................................................. 83 
13.5 STATUS/ERROR DURING CO2 MONITORING .................................................................................................... 84 
13.6 TYPICAL PRESSURES AND CO2 READINGS AT ALTITUDES ............................................................................... 85 
13.7 ACCESSORIES LIST.......................................................................................................................................... 85 
13.8 INSTRUCTIONS FOR SPO2 PROBE .................................................................................................................... 86 

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Chapter 1 Overview

1.1 Features
This monitoring system may be used to monitor patient’s physiological parameters: ECG, respiratory rate, body
temperature, non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), and pulse rate.
Note: If CO2 module is added, the monitoring will not have these two functions: central networking and body
temperature (temperature connector doesn't exist)
— It is lightweight, easy to carry and operate;
— 7″ high-resolution (800 × 480 pixel) color TFT to display patient’s ECG waveform, respiratory waveform and
SpO2 waveform;
— User-friendly and intuitive display interface, multiple configuration of ECG waveform display:
Main monitoring screen view: displays the information of all the waveforms and parameters visually.
Observing screen view: heart rate value and SpO2 value display in big fonts, and displays one channel ECG
waveform.
Seven lead waveforms on one screen view: displays the information of 7 ECG lead waveforms and different
monitoring parameters on one screen.
Five channel real-time waveforms and two hours’ trends screen view: intuitionistic knowing the
physiological status of patient.
oxyCRG screen: displays heart rate trend, SpO2 trend, respiration trend or waveform simultaneously on
oxyCRG screen, to know the instantaneous the change of physiological parameters of respiration.
— The cuff can be also used as a tourniquet, which is convenient and practical in use as an additional function,
and different cuff pressure can be set according to patient’s condition.
— Up to 20 types of arrhythmia can be analyzed automatically, waveform freezing is available and automatic
S-T segment measurement and manual analysis;
— Up to 1000 hours trend data of ECG, S-T, TEMP, CO2, SpO2, RESP and NIBP trends;
— Up to 2000 groups of arrhythmia events’ can be stored, as well as the corresponding HR , TEMP, CO2, SpO2,
and RR;

— Up to 12000 groups of NIBP measurement can be stored, as well as the corresponding HR, CO2, TEMP, RR
SpO2 and PR while the blood pressure measurement is taken, it can be recalled by list table or graphic trend.
— Up to 60 hours of ECG waveform storage (non-volatile) and can be reviewed;
— Accurate NIBP measurement with over-pressure protection;
— Unique pulse oximetry technique achieves accurate SpO2 and PR measurement;
— Visual and audible alarm, recall of alarm events;
— Flexible high and low alarm limits setting function;
— Real-time monitoring of battery capacity, when the battery power is insufficient, low battery voltage alarm
indication will display on LCD screen.
— Easy to color-code and change the color of the font, background and waveforms if need;
— Protection against defibrillator discharge and resistance against the interference from electrosurgical unit;
— Pacemaker pulse detection and inhibition functions are available;
— Patient type can be selected among “Adult”, “Pediatric” and “Neonate” in setup menu;

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— CO2 measuring function is optional;

— Built-in printer to output waveforms and text.

— Networking with the central station as a part of the central network;

1.2 Product Name and Model

Name: Patient Monitor
Model: Deluxe-70

1.3 Applications and Scope

This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult,
pediatric and neonate patients. With the functions of real-time recording and displaying parameters, such as ECG,
heart rate, non-invasive blood pressure, functional oxygen saturation, respiration rate, CO2, body temperature and so
on, it allows comprehensive analysis of patient’s physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by
qualified professionals only.

1.4 Operating Environment

1. Ambient temperature range: 5℃~40℃
Relative humidity: 30%~80%
Atmospheric pressure: 70kPa~106kPa
Power supply: 100~240VAC
Power frequency: 50/60Hz
2. This device should be situated in a place protected against direct sunlight, so as to prevent overheat inside it.
3. The device should be stored and used within specified temperature, humidity and atmospheric pressure range,
or it may cause damage to the device or inaccurate measurement result.
4. Do not use this device in an environment with toxic or inflammable gas.
5. If the device gets wet by accident, the operator should NOT power it on immediately until it has been
air-dried enough to avoid any damage to it.
6. This device should be fixed on a stand, so as to prevent possible shock.
7. Do not use with any equipment other than those expressly permitted in these instructions.
8. The monitor is defibrillator discharge-proof and has certain immunity to the interference from electrosurgical
unit. But when the device is used on the patient with pacemaker or used with electrosurgical equipment, the
user (doctor or nurse) should keep the patient under close surveillance for his/her safety. Refer to the
following function description for specific protective measures or notes.
9. Make sure that the equal-potential grounding terminal is grounded correctly.

10. Do not use mobile phone nearby, so as to avoid strong radiant field interference.

1.5 Impact on Environment and Resources

Low

1.6 Safety
a) This device conforms to IEC60601-1, electric safety classification: Class I, with Type BF and CF applied

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parts.
b) This device can resist against the discharge of defibrillator and the interference of electrosurgical unit.
c) This device can monitor the patients with pace-maker.
d) DO NOT use this device while the patient is under MRI scanning.

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Chapter 2 Working Theories of the Main Unit

2.1 Overall Structure and Working Theories

The overall structure of this monitor is shown as Fig.2.1.

Figure 2.1
This patient monitor is a product of modular design. It performs its measurement of the physiological parameter
through different modules. There are five functional modules for the monitor: ECG/RESP/TRMP module, NIBP
module, SpO2 module, CO2 module and Central Processing Unit (CPU) module.
1. ECG/RESP/TRMP module collects heart rate, respiration waveforms through the ECG leads and electrodes. It
also collects temperature data from the temperature probes.
2. SpO2 module collects data for pulse rate, pulse oxygen saturation (SpO2) and SpO2 volume waveform via the
SpO2 probe.
3. NIBP module collects blood pressure data, including the diastolic, systolic and mean arterial pressure through
the NIBP cuff. The cuffs are sized for adult, pediatric and neonate. NIBP measure has three modes: adult,
pediatric and neonate.
4. CPU module consists of main board, multi-function board, and the keyboard. The multi-function board
performs the data communication between the main board, ECG module, SpO2 module, NIBP module and CO2
module.
5. The CO2 module collects the date of respiration rate, EtCO2, InsCO2 through the sampling tube.

2.2 Composition
1. The monitor consists of the main unit and the corresponding functional components (ECG leads, non-invasive
blood pressure cuff, SpO2 probe, and temperature transducer or CO2 accessories.

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2. The monitor has 4 measurement channels: ECG and respiration channel, NIBP channel, SpO2 and pulse
channel and TEMP channel or CO2 channel.
3. The monitor has an output channel: networking communication port.
4. Basic parameters include: heart rate, respiration rate, NIBP, SpO2, pulse and CO2 ,TEMP

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Chapter 3 Installation and Connection

3.1 Introduction to Panels

3.1.1 Front Panel

10

1 2 3 4 5 6 7 8 9

Figure 3.1 Front Panel

1. Power switch: Press it for 3 seconds to start the monitor or turn off the monitor.

2. ～
～--AC power indicator: When it is light it means that AC power supply is being used
3. -Built-in DC power indicator:

When both AC and DC indicators are on, it means that AC power supply is applicable, and the battery is
being recharged. If only DC indicator is on, it means that the battery is being used.

4. ECG lead: Click it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF
and V.
z When the option of Print in the System Menu is ON, the ECG lead Key will be changed into Print
Press this key to print different waveform on different screen.
z In the Initial Screen, press this key to print Lead II ECG waveform and Waveform 2 which can be
selected in the System Menu.
z In the Data List Screen, press this key to print NIBP data list.
z In the Observing Screen, press this key to print Lead II ECG waveform and Waveform 2.
z In the 7 leads on the Same Screen, press this key to print Lead II ECG waveform and Waveform 2.
z In the SpO2 Data List Screen, press this key to print SpO2 data list.
z In the Graphic Trend Screen, press this key to print trend graph.
z In the System Parameter Setting Screen, press this key to print the system parameter setup.

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z In the Recall Screen, press this key to print recalled data list or current ECG waveform and arrhythmia
waveform.
z In the Arrhythmia Screen, press this key to print arrhythmia list or current ECG waveform and
arrhythmia waveform.

5. Alarm silence: Press key to set or activate the system alarm. In the monitoring screen,
press “Alarm” to set the alarm timer. There are four options of alarm silent time: 2 minutes, 5 minutes, 10
minutes and 20 minutes. The time shows up on the upper left corner of the screen. When the alarm timer is
activated, the system begins to count down. If alarm occurs during that period, the system alarm will be
activated automatically and the monitor will give alarm. If there is no alarm during that period, when the
set time has passed, the system alarm will be activated as well.

When the monitor alarms, press key to suspend the alarm and set the alarm silence time.
0 DO NOT silence the audible alarm or decrease its volume or patient safety
could be compromised.

6. Freeze: Press the key to freeze/unfreeze ECG waveform or the waveforms of ECG, SpO2 and
RESP according to the system setting, and enter into ST segment measurement screen for analysis (on
Observing Screen).

7. NIBP: Press it to start or stop NIBP measurement.

8. DISP: Click it to shift the display modes or return to the Main Screen from other screens. Press
it to shift between Main Screen and Display 2 Screen which can be set in System Menu screen.

9. Navigation Knob: It is the major operating key of the system, which can be used to select functions or
parameters. Press and release it to shift the screen and to confirm the function or other operating tips.
10. Alarm indicator:

Indicator Color Alarm Level Alarm Event

Red flashing High priority alarm Exceeding the limits, pulse stop or suffocation, low
battery voltage
Yellow flashing Middle priority alarm Leads and probe off, VE RONT and SVE RONT
Yellow light Low priority alarm Other arrhythmia phenomenon
Green light Normal

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3.1.2 Left and Right Panel

Figure 3.2 the left panel Figure 3.3 the right panel
Different ports are located in different positions of the monitor for operating convenience.
The cable and transducer ports are at the left panel, shown in Figure 3.2.
1. SpO2: SpO2 probe connector
2. NIBP: NIBP hose connector
3. TEMP: TEMP probe connector (CO2 : CO2 probe connector)
4. ECG/RESP: ECG cable connector
5. Symbol definition
With type BF applied parts
With type CF applied part and applicable during the defibrillator is used.

Caution. Please read the manual for details.

The power supply socket and ports are at the left panel, shown in Figure 3.3.

1. ：Power supply socket(DC input)

2. ：Serial communication port which is used to network with central monitoring system.

3. ：USB port (reserved for future use);

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3.1.3 Rear Panel

Figure 3.4 Rear panel

The following are at the rear panel of the monitor.
(1) S/N: Serial Number
(2) Power supply socket: 100-240VAC
(3) Nameplate

CE mark

Serial number

Authorised representative in the European community

Disposal of this device according to WEEE regulations

(4) —battery lid. Remove the battery lid to install or change the rechargeable battery. Battery
specifications: Li-ion 14.8V/2200mAh rechargeable battery pack.

To avoid battery damage, do remove battery(s) before shipping or storage.

Caution: Burn hazard (the built-in battery)

Do not disassemble, incinerate or expose to high temperature (60℃/140℉).
Refer to instruction manual.

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3.2 Installation
3.2.1 Opening the Box and Check

1. Open the packaging, take out the monitor accessories from the box carefully and place it in a safe stable and
easy to watch position.
2. Open the users’ manual to sort the accessories according to the packing list.
‹ Inspect the accessories for any mechanical damages
‹ Check all the exposed leads and inserted accessories
☞ You can customize the module configuration by choosing necessary modules to meet your own needs.
Therefore, your monitor may not have all the monitoring functions and accessories.

Please contact the local dealer or our company in case of any problems. We are to offer you the best solution for
your satisfaction.

3.2.2 Power Supply

1. When powered by AC mains power supply:
‹ Make sure that the AC power supply is 100-240VAC, 50/60Hz.
‹ Use the power cable prepared by the manufacturer. Insert one end of it to the power port of the monitor
and the other end to the grounded three-phase power jack.
‹ To eliminate potential differences, the monitor has a separate connection to the equipotential grounding
system. Connect one end of the provided ground cable to equipotential grounding port on the rear of
the monitor, and connect the other end to one point of the equipotential grounding system.
Caution: ensure that the monitor is grounded correctly.
 After the supply mains has been interrupted when power switch remains in the “on” position and is restored
after a period of time that is longer than 30 seconds, the monitor will run by the last settings when restarting
the monitor.
2. When powered by built-in battery
‹ The provided battery of the monitor must be recharged after transportation or storage. So if the monitor
is switch on without being connected to the AC power socket, it may not work properly due to
insufficient power supply.
‹ It will be fully charged after about 3 hours when the monitor is off and about 5 hours when the monitor
is on.

3.2.3 Starting the Monitor

The system performs self-detection and enters initial display after switch on the monitor, and the yellow alarm
indicator blinks to inform that the user can begin operating it.
‹ Check all the applicable functions to make sure that the monitor works normally.
‹ If the built-in battery is applied please recharge it after using the monitor to ensure sufficient power
storage. It will take minimal 8 hours to charge battery from depletion to 90% charge.
0 Do not use the monitor to monitor the patient if there are indications of damage or reminders of
error. Please contact the local dealer or our company.
 Start the monitor again 1 minute later after it is switched off.

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3.3 Connection
3.3.1 ECG Connection

ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and the lead.
The lead connects the monitor. The locations of the electrodes are very important for obtaining accurate ECG signals.
1. Connect the cable to the right-panel connector marked with the ECG icon.
2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid variations in electrical
resistance. For ECG monitoring, it is strongly recommended to use silver/silver chloride electrodes. When
dissimilar metals are used for different electrodes, the electrodes may be subject to large offset potentials due
to polarization. Using dissimilar metals may also increase recovery time after defibrillation.
3. Prepare the electrode sites according to the electrode manufacturer’s instructions.

4. Skin clean
¾ Clean and dry-abrade skin to ensure low sensor impedance. Mild soap and Water is recommended as a skin
cleanser.
Note: Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause high sensor
impedance. If alcohol is used, ensure 30-second dry time.

¾ Dry-abrading the skin gently with a dry wash cloth, gauze, or skin preparation product is helpful to remove
the non-conductive skin layer.

The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator proof.
The locations of the electrode are in the following Figure:

Figure 3.5 Electrode Location

Note: If skin rash or other unusual symptoms develop, remove electrodes from patient.
After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system will
display “LEAD OFF” on the screen to alarm the operator.
 It might not display ECG wave with 3 leads. The 5 leads should be used to have ECG wave.

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5. The ECG leads and their corresponding locations are as follows

Symbol Position
The intersection between the centerline of the right
RA
clavicle and Rib 2
The intersection between the centerline of the left clavicle
LA
and Rib 2
LL Left part of the upper abdomen
RL Right part of the upper abdomen
C1(V1)
C (V) C2(V2)
C3 (V3) The electrodes are placed in different places, the different
Chest C4 (V4) lead forms will display.
electrode C5 (V5)
C6 (V6)
Safety Instructions for ECG Monitoring

 This Patient Monitor can only be equipped with ECG leads provided by our company; using ECG leads
supplied by other companies may cause improper performance or poor protection while using defibrillator.

 Electric parts of electrodes, leads and cable are forbidden to contact any other conductive parts (including
ground).

 This Patient Monitor can resist against defibrillator and electrosurgical unit. Readings may be inaccurate for
a short time after or during using defibrillator or electrosurgical unit.

 Transient caused by cable circuitry blocks while monitoring may be similar to the real heartbeat waveform,
as a result resistance heart rate alarm rings. If you put the electrodes and cable in proper places according to
this manual’s instructions and the instructions for using electrode, the chance of this transient occurring will
be decreased.

0 To the patient with pacemaker, due to that this device has been designed to provide resistance to pacemaker
signal interference, generally the pacemaker pulse is not counted in heart rate measurement and calculation,
but when the cycle time of pacemaker pulse is over 2ms, it may be counted. In order to reduce this
possibility, observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart rate
display and alarm system of this monitor when monitoring this kind of patients. Keep pacemaker patient
under close surveillance.

0 Besides the improper connection with electrosurgical unit may cause burns, the monitor may be damaged or
arouse deviations of measurement. You can take some steps to avoid this situation, such as do NOT use
small ECG electrodes, choosing the position which is far away from the estimated Hertzian waves route,
using larger electrosurgical return electrodes and connecting with the patient properly.

0 No predictable hazard will be caused by the summation of leakage currents when several item of monitor
are interconnected.
 ECG leads may be damaged while using defibrillator. If the leads are used again, please do the functional
check first.

 When the monitor is inoperable due to an overload or saturation of any part of the amplifier, it will prompt
“Lead off” to remind operator.

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3.3.2 Blood Pressure Cuff Connection

1. Connect the cable to the right-panel connector marked with the NIBP icon.
2. Unveil and wrap the cuff around patient’s upper arm.
Requirements of the cuff:
1) Appropriate cuff should be selected according to the age of the subject. Its width should be 2/3 of the length of
the upper arm. The cuff inflation part should be long enough to permit wrapping 50-80% of the limb concerned.
See the table below for the dimensions:
Note: The size of the cuff selected should suit the subjects while measuring.
Cuff Model Arm Circumference Cuff Width
Neonate Cuff 6.0cm~9.5cm 3cm
Small-sized Pediatric Cuff 6cm～11cm 4.5cm
Middle-sized Pediatric Cuff 10cm～19cm 8cm
Large-sized Pediatric Cuff 18cm～26cm 10.6cm
Adult Cuff 25cm～35cm 14cm

2) When putting on the cuff, unveil and wrap it around the upper arm evenly to appropriate tightness.
3) Remember to empty the residual air in the cuff before the measurement is commenced.
4) Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery
is observed.
5) The cuff should be tightened to a degree where insertion of one finger is allowed.
6) The lower end of the cuff should be 2cm above the elbow joint.

.
Figure 3.6 Cuff Position

Safety Instructions for NIBP Monitoring

0 When taking the measure of an infant’s (less than 10 years old) blood pressure, do NOT operate in
the adult mode. The high inflation pressure may cause lesion or even body putrescence.

0 It is recommended to take the blood pressure measurement manually. Automatic or continuous

measurement should be used at the presence of a doctor/nurse.

0 NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell
disease, or partial bleeding will appear.

0 Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise,
damages may be caused to the limbs.

0 Pay attention to the color and sensitivity of the limb when measuring NIBP; make sure the blood
circulation is not blocked. If blocked, the limb will discolor, please stop measuring or remove the

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cuff to other positions. Doctor should examine this timely.

0 The time of the automatic pattern noninvasive blood pressure measurement pull too long, then the
body connected with the cuff possibly have the purpura, lack the blood and the neuralgia. When
guarding patient, must inspect the luster, the warmth and the sensitivity of the body far-end
frequently. Once observes any exception, please immediately stop the blood pressure measurement.

 The subject should lie on the back so that the cuff and the heart are in a horizontal position and the
most accurate measure is taken. Other postures may lead to inaccurate measurement.
 Do not speak or move before or during the measurement. Care should be taken so that the cuff will
not be hit or touched by other objects.
 The measurements should be taken at appropriate intervals. Continuous measurement at too short
intervals may lead to pressed arm, reduced blood flow and lower blood pressure, and resulting
inaccurate measure of blood pressure. It is recommended the measure be taken at intervals of more
than two minutes.
 When an adult subject is monitored, the machine may fail in giving the blood pressure measure if
the infant mode is selected.
 Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate
measurement.
 Do NOT twist the cuff tube or put heavy things on it.

 When unplugging the cuff, hold the head of the connector and pull it out.

The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator proof.
¾ Pressure Accuracy Verification
Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP
module inside the device. Technician or equipment manager should do pressure accuracy verification every half
year or year in order to check if the pressure measurement still conforms to the requirement of product
performance. If the deviation is beyond the declared specification, it is permitted to return it to factory for repair
or calibration. Before verification, please connect the monitor to a standard pressure meter as the reference
equipment like a mercury pressure meter.

Figure 3.7 Connection of Pressure calibration fixture

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Mode 1: The inflation can be activated by Monitor so the pressure will increase automatically untill it
exceeds the limit value specified in table A. This pressure limit value depends on the patient type selection
as shown in table A:

Adult 240mmHg

Child 200mmHg

Neonate 120mmHg
Table A
During the inflation, the Monitor will close the deflating valve, and the pressure value will be shown during
the process. If there is no manual deflation operation, the pressure will persist until deflation by manual
operation, so it is necessary to use a manual valve for doing adequate deflation in several steps to verify the
pressure accuracy in the full scale of measurement range.
Mode 2: No automatic inflation by Monitor during the pressure accuracy verification.
Increase the pressure manually by the pumping balloon, and the verification can be done by applying different
pressure value manually. If the increased pressure exceeds the given limit as shown in table B, the Monitor will
deflate automatically because of over-pressure protection.

Adult 300mmHg

Child 240mmHg

Neonate 140mmHg
Table B

 After the verification, do press the button again to return to normal working mode, then continue
other operation, or the NIBP key will be invalid.
 Pressure accuracy verification must be operated by technician or equipment manager. Doctor or
nurse is not allowed to do the verification, it is very dangerous especially when the pressure cuff is
still on patients.
¾ Air Leakage Check
In order to avoid significant error of blood pressure measurement or even no measurement result caused by air
leakage in the pneumatic system including the cuff during measuring, it is recommended to check if there is leak
in the pneumatic system as well.
 Please remove the cuff from patient while performing the leakage check.

3.3.3 To connect the SpO2

SpO2 probe is very delicate equipment. Please follow the steps and procedures in operating it. Failure to operate it
correctly can cause damage to the SpO2 probe.
Operation procedure:

1. Connect the SpO2 probe to the right panel’s jack labeled “SpO2”. When unplugging the probe, be sure
to hold the head of the connector and pull it out.

2. Insert one finger into the probe (index finger, middle finger or ring finger with proper nail length)
according to the finger mark on the probe, shown as below.

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 User Manual for Patient Monitor

Figure 3.8 Demonstration for SpO2 probe

When selecting a sensor, consider the patient’s category, adequacy of perfusion, availability of probe site and
anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor. Read the
following table for SpO2 probe information. Refer to Chapter 13.8 for the detailed instructions of each SpO2 probe.

SpO 2 Probe Patient Category

SpO 2 Finger clip Sensor (reusable) Pediatric
SpO 2 Finger rubber Sensor(reusable) Adult
SpO 2 Finger clip Sensor(reusable) Adult

High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. To
prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with
opaque material.

Failure to take this action in high ambient light conditions may result in inaccurate measurements.
If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a
less active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive
backing.

For reusable sensors, follow the sensor directions for use for cleaning and reuse. For single-patient use sensors, use a
new sensor for each patient. Do not sterilize any sensor by irradiation, steam, or ethylene oxide.

Safety Introductions for SpO2 Monitoring

0 Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with
microcirculatory problem. It is recommended that the sensor should NOT be applied to the same
place for over two hours, change the measuring site periodically if necessary.

0 The measuring site is generally changed every 3hours. The measuring site should be inspected for
ensuring no abnormity every 1~2 hours. If abnormity occurs, change the measuring site periodically
if necessary.

0 When the ambient temperature is over 35℃, please change the measuring site every two hours if
necessary.

0 Burn hazard: When the ambient temperature is over 37℃, do not use the SpO2 sensor for a long time.
0 SpO2 measuring position must be examined more carefully for some special patient. Do NOT install
the SpO2 sensor on the finger with edema or fragile tissue.

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0 Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP measuring
will affect SpO2 measuring and cause the alarm error.
 If sterile packaging of SpO2 sensor is damaged, do not use it any more.

 Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor.
 When the temperature of SpO2 sensor is abnormal, do not use it any more.
 Please do not allow the cable to be twisted or bended.
 Please do not use nail polisher or other cosmetic product on the nail.
 The fingernail should be of normal length.
 The SpO2 sensor can not be immerged into water, liquor or cleanser completely, because the sensor has no
capability to resist the harmful ingress of water.

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M for Patien
nt Monitor

3
3.3.4 Printeer connection
1
1. PRINTER
R：USB portt, connect thee monitor to the
t provided USB
U cable.
22. DC12V：DC power supply
s port. Power indicaator on the frront panel wiill be on afterr the adapter is connectedd to
p
power supplyy.

Figure3.9 rearr panel of prrinter

3
3.3.5 Loadiing printingg paper
Step 1: Oppen the coverr of the printeer
Step 2: Innstall the papeer to the printter properly
Step 3: Puull the paper out
o of the prinnter for 2 or 3 cm
Step 4: Cllose the printeer cover

" The ERR

ROR indicatoor on the top right
r corner of
o the printer will
w be on whhen the printiing paper runs out.

Figgure 3.10 f
front panel

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 User Manual for Patient Monitor

3.3.6 Battery Installation

1. Make sure that monitor doesn’t connect to mains power supply.
2. Unscrew the screw on the battery lid with a screwdriver and open the battery cover.
3. Insert the battery connecting wire into the battery receptacle (Do not insert the plug in reverse).
4. Insert it into the battery compartment.

Battery connecting wire

Battery receptacle
Battery label

Figure 3.11 Battery Installation

5. Close the battery lid and fasten it with the screw.
 Please take out the battery from battery compartment, if it won’t be used for a long time.

3.3.7 Handle Installation

1. Take out the handle subassembly if necessary.
2. Fix the handle subassembly on the rear panel with two screws, see Figure 3.12.

Figure 3.12 Handle Installation

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Chapter 4 Monitoring Screen

4.1 Date and Time Setup

Instead of entering into monitoring screen, it shows the date and Time Setup screen immediately after the monitor is
started, shown in Figure 4.1:

Figure 4.1 Time Setup

The system will stay on this screen for 10 seconds. If you do not rotate the navigation knob within this period, the
screen will enter into the Main Screen.

Follow the steps below to set date and time.

Step 1: Rotate Navigation Knob, move the gray cursor to “Edit”.

Step 2: Press the knob, and then “Edit” turns into “Save”. The gray cursor stays on the Year of the date. Press the
knob again and the gray cursor becomes highlighted. Rotate the knob left or right to increase or decrease
the year value.

Step 3: When the Year is set, press the knob to move the gray cursor to the Month of the date.

Step 4: Repeat Step 2 and Step3 to adjust the Year, Month, Date, Hour and Minute.

Step 5: If you have finished adjusting the date and time, press the knob and rotate the knob to move the cursor to
“Save”. Press it to save the settings and exit the date and Time Setup screen, meanwhile enter into the
Main Screen shown in Figure 4.2. If you press “Exit”, the settings will not be saved.
The system is initialized and enters into Main Screen where monitoring and system operation are performed (as shown
in Figure 4.2).

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4.2 Main Screen

Figure 4.2 Main screen

Border area
— “Alarm ”: Audible alarm status, green “ ” indicates the audible alarm is enabled, yellow “ ”
indicates the alarm sound is silent. The audible alarm will be activated again automatically after the end
of given counting down or when a new type of alarm event occurs. Red “ ” indicates the audible
alarm is disabled, that means the alarm sound is off, this is also normal situation when the alarm sound
volume is set to “0” in system parameter settings.
— “ADUL”: The type of the monitor subject. There are two modes available: “Adult” and “Infant”.

— “MON”: ECG Filter type. There are three types: “Diagnosis”, “Monitor” and “Operation”. The option
can be set in the System Menu.

— : battery power indicator; When the indicator is yellow and displays only one “grid”, it
means there is a little battery power left. When the indicator turns red and blinks, as well as less than
one “grid” displays, the system alarm will be on to remind the battery shortage. Please connect the
device to the mains power supply in time to ensure the normal use of monitor, and the battery will be
recharged. When the battery power is full, battery power indicator displays full grid. During recharging,
the grids in the battery indicator are rolling circularly.

— “2011-03-02 13:57:25”: Current calendar time and date. The system time and date can be set during the
system start-up when the screen displays the time and data setups. The current figure shows the time
nd
and date is March 2 , 13:57:25, 2011.

— “Push knob for System Menu”: System prompt or description for the current status.

— “ID”: The patient ID. The patient ID can be entered or changed in the archive management window.
Waveform area
— 1st trace: The first trace is ECG waveform for lead II. The left side of the ECG shows the sign I, which
indicates the ECG scale. The scale sign changes its length according to the ECG gains. All ECG

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waveforms have their own scale. When the third trace change to lead II, the first trace will automatically
change to lead I.

— 2nd trace: The second trace is for the ECG waveform of lead III. When the third trace displays the ECG
for the lead III, this trace automatically changes to the ECG for lead I.

— 3rd trace: Its lead can be adjusted and will not repeat the 1st and 2nd traces.

— 4th trace: SpO2 plethysmograph.

— 5th trace: Respiration waveform.

Data area:

Figure 4.3 Heart rate area

— “HR”: The currently displayed heart rate. The 61 on the right side is the heart rate measured.

— “bpm”: The heart rate unit. bpm = beat per minute.

— “ ”: The heart beating symbol. Its flashing corresponds to the R wave of the ECG waveform. The
speed is the same with the heart rate.

— “ST+0.09mv”: the measured mili-volts value of automatic ST measurement.

— “X1”: ECG waveform gain (amplification), 6 options available

“Auto” Automatic scaled waveform.
“×1/4” Waveform scaled with 1/4 of the base gain.
“×1/2” Waveform scaled with half of the base gain.
“×1” Waveform scaled with base gain.
“×2” Waveform scaled with twice of the base gain.
“×4” Waveform scaled with four times of the base gain

Figure 4.4 Blood pressure data area

— “NIBP”: The blood pressure type labels and the measured value.

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— “mmHg”: NIBP unit

— “12:56”: The time of NIBP measuring
— “Manu”: The NIBP measurement mode.

Figure 4.5 TEMP data area

— “TEMP”: Temperature label. The value below “36. 7” is the temperature value.
— “℃”: Body temperature unit.℃ is Celsius, and °F is Fahrenheit.

Figure 4.6 SpO2, pulse rate, and respiration data area

— “SpO2”: SpO2 label. The “98” on the right side is the current SpO2 value measured.
— “PR”: Pulse rate label. The value “62” on the lower left shows the pulse rate value.
— “ ”: SpO2 strength bar.
— “RR”: Respiration Rate: The rpm is the unit of the respiration.
— “16”: Respiration rate.
— “X2”: Respiration gain (amplification)
“×1/2” Waveform scaled with half of the base gain.
“×1” Waveform scaled with base gain.
“×2” Waveform scaled with twice of the base gain.
“×4” Waveform scaled with four times of the base gain
Operation Instructions:

ECG lead: press it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF and V.

Alarm silence: press it to set or activate the system alarm.

Freeze: press it to freeze ECG waveform or the waveforms of ECG, SpO2 and RESP according to the
system setting.

NIBP: press it to start or stop NIBP measure.

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DISP: press it to shift the display to Display 2 Screen.

Navigation Knob: 1. Press the navigation knob about 3 seconds, enter system menu screen.
2. Rotate the knob to move the gray cursor to the corresponding item, and press it for 1
second to enter

4.3 Display 2 Screen

4.3.1 Observing Screen
Press the DISP key to shift screen to Observing Screen when setting Disp2 as “Obsev” in System Setup screen, as
shown in Figure 4.7.

Figure 4.7 Observing Screen

Operation Instructions:

ECG lead: press it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, and Ⅲ, AVR, AVL, AVF
and V.

Alarm silence: press it to set or activate the system alarm.

Freeze: press it to freeze the ECG waveform and perform manual S-T segment analysis. Double
press this key within 2 seconds to lock or unlock the operation of all other buttons (except
power switch) on the front panel.

NIBP: press it to start or stop NIBP measure.

DISP: press it to shift the display to the Main Screen.

Navigation Knob: No action. When pressing the “Freeze” key, this key is used for S-T segment analysis.

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4.3.2 NIBP screen

Figure 4.8 NIBP Screen

Press the DISP key to shift the Main Screen to NIBP screen , as shown in Figure, when setting Disp 2 as “NIBP” in
“system menu→system setup→Disp2”. In NIBP screen, PR from SpO2 is shown prior to PR from NIBP.

Operation Instructions:
EGG lead: No action. When the printer is on, it serves as the printing key.

Alarm silence: Press it to enable/disable alarm silence.

Freeze: No action.

NIBP: Press it to start NIBP measurement, and press it again to cancel measuring NIBP.

Shift: Press it to shift the display to the Main Screen.

Navigation knob: No action.

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4.3.3 Seven ECG Waveforms on the Same Screen

Press the DISP key to shift screen to 7 ECG Waveform Screen when setting Disp2 as “7 ECG” in System Setup screen.
In this screen, the operator can simultaneously view the ECG waveform for 7 leads: I, II, III, AVR, AVL, AVF and V, as
shown in Figure 4.9.

Figure 4.9 7 Leads on the Same Screen

Operation Instructions:

ECG lead: No action. When the printer is on, it serves as the printing key.

Alarm silence: press it to set or activate the system alarm.

Freeze: press it to freeze all 7 ECG waveforms. Double press this key within 2 seconds to lock or
unlock the operation of all other buttons (except power switch) on the front panel.

NIBP: press it to start or stop NIBP measure.

DISP: press it to shift the display to the Main Screen.

Navigation Knob: rotate the knob to adjust the gain for all 7 ECG waveforms. The ECG gain includes 6
options: “Auto”, “X1/4” “X1/2”, “X1”, “X2”, “X4”.

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4.3.4 Five Channels Real-time Waveforms and Trends on the Same Screen

When the Disp2 option is “Trend” on System Menu screen, press the DISP key on the Main Screen, the system will
enter the trend screen, as shown in Figure 4.10. Five channel real-time waveforms and trend graph can be viewed on
this screen.

Figure 4.10 Five Channel Real-time Waveforms and Two Hours Trends
On this screen, the first channel waveform is ECG waveform of Lead II; the second (CAS) one is the continued ECG
for the first channel waveform; the third one is ECG waveform of Lead I; the fourth one is SpO2 waveform; the last
channel is respiration waveform. On the right of waveform area, from the top down, respectively is heart rate,
temperature, SpO2, RR trend graph, the abscissa of trend graph (-2h-0) means various trend of every parameter value
from now on to two hours before, waveform in trend graph shifts from right to left.
Operation Instructions:

ECG lead: press it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, and Ⅲ, AVR, AVL, AVF
and V.

Alarm silence: press it to set or activate the system alarm.

Freeze: press it to freeze ECG waveform or the waveforms of ECG, SpO2 and RESP according to
the system setting. Double press this key within 2 seconds to lock or unlock the operation of
all other buttons (except power switch) on the front panel.

NIBP: press it to start or stop NIBP measure.

DISP: press it to shift the display to the Main Screen.

Navigation Knob: no action.

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4.3.5 Parameter screen

Press the DISP key to shift screen to Parameter Screen when setting Disp2 as “Parameter” in System Setup screen, as
shown in Figure 4.11

Figuer 4.11 Parameter screen

Operation Instructions:

ECG lead: when the printer is on, it serves as the printing key.

Alarm silence: press it to set or activate the system alarm.

Freeze: no action. Double press this key within 2 seconds to lock or unlock the operation of all
other buttons (except power switch) on the front panel.

NIBP: press it to start or stop NIBP measurement.

DISP: press it to shift the display to the Initial Screen.

Navigation Knob: no action.

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4.4 Freeze and S-T Analysis Screen

During the process of monitoring, the ECG waveform can be frozen to perform detailed analysis in the observing
screen, as shown in Figure 4.12.

Figure 4.12 Frozen and S-T Analysis Screen

4.4.1 Screen Description

Freezing, ST segment analysis screen is similar with the observing screen, except the waveform is frozen. For example,
the Figure 4.13 is a portion of the frozen waveform. The symbols on the screen were described briefly on the screen.

Figure 4.13 Frozen waveform

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4.4.2 How to Analyze the S-T Segment on ECG Waveform

The operator can use the “Navigation Knob” to analyze the S-T segment waveform, i.e. measuring the difference
between the S-T segment value and the referenced value. The value is displayed after the measure on “S-T + 0.000
mV”. The operation is carried out in 4 steps.

Step 1: rotate the “Navigation Knob” to move the base point (the red cross) horizontally to base line point (the base
line is between the Q wave and the P wave). At this point, the frozen screen shows “S-T+0.xxx mV, Set Base, Dirc
Hor”

Step 2: press the “Navigation Knob”. The screen shows “S-T+0.xxx mV, Set Base, Dirc Ver”. Then rotate the knob to
move the base point vertically to the base line point.

Step 3: press the “Navigation Knob” again. The screen shows “S-T+0.xxx mV, Set ST, Dirc Hor”. Rotate the knob to
move the S-T point (the yellow cross) horizontally to the point to be measured on the ST segment.

Step 4: press the “Navigation Knob” again. The screen shows “S-T+0.xxx mV, Set ST, Dirc Ver”. Rotate the knob to
move the S-T point vertically to the point to be measured on the S-T segment.

Only the observing screen allows pressing the freeze key to enter the S-T segment analysis screen.
NOTE: The S point is the end point of S wave, and the T point is the start point of T wave.
Operation Instructions:

ECG lead: press it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, and Ⅲ, AVR, AVL, AVF
and V.

Alarm silence: press it to set or activate the system alarm.

Freeze: press it to unfreeze ECG waveform.

NIBP: press it to start or stop NIBP measure.

DISP: press it to shift the display to the Main Screen.

Navigation Knob: analyze the S-T segment waveform

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Chapter 5 CO2 Monitoring

If your monitor has CO2 monitoring function, please follow the instructions in this chapter to perform CO2
monitoring on patient. The parameter setting menu and monitoring menu differ from different models, please refer to
the monitor on hand.

5.1 CO2 Parameter Settings

1. On Main Screen, press the knob to enter System Menu Screen. Then choose “SETUPÆC02”to enter CO2
Parameter Settings screen.

Figure 5.1 CO2 Parameter Settings (1)

CO2 Parameter Settings (2)

NOTE: CO2 parameter setting screen will be displayed in two pages. Focus the gray cursor on “ ”, then press
the navigation knob to enter the second page where the operator can set some other parameters of CO2 (As shown in
above figures).
— Switch: choosing the mode of CO2. It is recommended that the switch is turned on only when there is a
need to monitor CO2 parameter. This can not only reduce the power consumption and also extend the life
of the CO2 module.
In order to maintain the monitor, please set CO2 switch at OFF state in system setup when CO2 function is
not used.
— Gain: the CO2 waveform gain.
— Unit: Choosing the EtCO2 and the minimum InsCO2. It can be set up as kPa, mmHg, and %.
— Respiration Rate High: Setting the upper alarm limit of CO2 respiration rate.
Low: Setting the lower alarm limit of CO2 respiration rate.
— EtCO2 High: Setting the upper alarm limit of EtCO2.
Low: Setting the lower alarm limit of EtCO2.
— InsCO2 High: Setting the upper alarm limit of InsCO2.
Low: Setting the lower alarm limit of InsCO2.

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— Baro (Barom
B metric pressu ure): set ambiient atmospheeric pressure.. It can be dettermined by barometer
b or the
a
ambient altituude. Altitude can be used to determinee the typical barometric ppressure if a barometer
b is not
a
available, refeer to Appendiix Typical Preessures and CO
C 2 Readingss at Altitudes for details.
— Zero: The meethod to calibbrate CO2: Zeero calibration
Z n. Calibrationn must be carrried out in a drafty
d place, and
t CO2 moddule must havve worked coontinuously for
the f 5 minutess to ensure ann accurate caalibration, or the
c
calibration wiill not work.
— F
Flow w rate of the CO2 sampling. Its value iss 50ml/min.
(CO2 flow): It is flow
T informatiion promotedd for Zero caliibration is as follows:
The

Please apply the

P t reference air with 0% CO2, the air in the drafty room usuallyy can be regarrded as the aiir with 0% CO2.
P
Press “OK”, and
a the resultt will be displlayed on the screen
s severaal seconds later.
— Apnea: displayy time of thee respiration rate value in i data area when the prrevious respiiration has been b
deteected while thhe next one iss not, meanwwhile, the deviice will prom
mpt apnea infoormation. Thee setting rangge is
10ss~60s, the default is 20s. For examplee, if 20 secon nds is set heree, it means thhe respiration
n rate value will
w
disaappear after it has been shown
s for 200 seconds in the data areaa if on respirration is deteected during this
period.
— Perriod: setting the calculatiion cycle of EtCO2 valuee, there are three
t selectabble options: “1b”,
“ “10s” and
“200s”. “1b”: meeans the EtCOO2 value will be
b calculated
d once every respiration
r cyycle; “10s”: means
m the EtC
CO2
valuue will be caalculated oncce every 10s, and the maxximum EtCO O2 value meassured during this 10s willl be
dispplayed on data area; “20s”: means the EtCO2 valuee will be calcculated once eevery 20s, annd the maximmum
EtC
CO2 value measured duringg this 20s willl be displayed on data areea
— TEMP: setting the temperaature value of the currentt measured air a flow. For instance, thee temperaturee is
usuually set as 37℃
3 while measuring
m thee patient’s reespiration by air flow. Hoowever, if thee air flow too be
meaasured is thee reference gaas, the tempeerature is sett as 25℃. Thhe setting rannge: 0~50; Unit:
U ℃; Deffault
valuue: 35.0.
— O2 Compen: addjusting the concentration
c w. Generally, the
of compensaating gas in patient’s respirration air flow
mpensating gas is oxygenn, so it can bee called oxyg
com gen compenssation concenntration. The unit: %; Settting
range: 0%~100%
%; Default vaalue: 16.
— Ballance: settingg the balance gas in patiennt’s respiratio
on air flow. There
T are threee kinds of seelectable balaance
gass: “Air”, “N2OO” and “He””, namely: airr, nitrous oxid de and heliumm. If on speccific balance gas is given, the
balaance gas can be set as “Aiir”.
— Ageent: setting whether
w addiing the anesthhetic gas to patient’s
p resppiration air fllow and the concentration
c n of
aneesthetic gas. The
T setting raange is 0.0%~
~20.0%, the default
d status is: not addingg anesthetic gas,
g that’s to say,
the concentration is 0.0%.
2 To set the color
2. c of CO2 parameterss on Color Seettings screen
n.

5 CO2 Sensor
5.2 S C
Connectio
on

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5
5.2.1 Sidesttream CO2 Sensor Coonnection

Deemonstration n for Sidestreeam CO2 Sen

nsor Connecction
1 Take out thhe CO2 Sensoor and insert the
1. t CO2 Senssor Cable into
o the connecttor labeled “C
CO2” on the connector
c pannel
of the moniitor;
2 The samplee cell of the sampling
2. s cannnula must be inserted into the sample cell
c receptaclee of the CO2 Sensor. A “cllick”
will be heard
h when thhe sample ceell is properlly inserted. Then
T connecct to airway tube. After finishing
f sennsor
connection, and makee sure that thhe air input end is expossed to room air and awaay from all sources s of CO2,
including the ventilatoor, the patientt’s breath andd your own. Next,
N turn onn the CO2 swiitch at CO2 Setup Screen and
a
then wait 2 minutes forr the sensor warm-up.
w
3 Default Tu
3. ubing Configguration

Adaptter and Samp

pling tube (S
Single patientt use)

Extendiing airway tu
ube for conn
necting to sam
mpling tube (Single patieent use)

Wye Connector
C

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4. Optional sampling cannula kits

(1) T connector sampling cannula kits

On-air Connector

Adapter
(2) Nasal Sidestream Cannula Kits

(3) Oral Sidestream Cannula Kits

5.2.2 Mainstream CO2 Sensor Connection

Sensor cable

Adapter

CO2 sensor

Demonstration for Mainstream CO2 Sensor Connection

1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labeled “CO2” on the connector panel
of the monitor;
2. Snap the CO2 sensor onto the airway adapter as shown in Figure 6.9. A “click” will be heard when the airway
adapter is properly inserted.
3. Position the airway adapter in the patient’s respiratory circuit (as close to the patient as possible) between the
endotracheal tube and the ventilator circuit. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2
minutes for the sensor warm-up.

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Safety Introductions for CO2 Monitoring

0 CO2 Sensor is a precision measuring part, please use it correctly and store it
properly;
0 Precautions for electrostatic discharge (ESD) and electromagnetic interference
(EMI) to and from other equipment.
0 Failure of Operation: If the CO2 Sensor fails to respond as described in this user
manual; DO NOT use it until approved for use by qualified personnel.
0 DO NOT position the sensor cables or tubing in any manner that may cause
entanglement or strangulation.
0 Support the airway adapter to prevent stress on the ET tube.
0 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2
airway adapters may compromise functionality and system performance leading
to a user or patient hazard. Performance is not guaranteed if an item labeled as
single patient use is reused.
0 Inspect the sidestream on-airway adapters and sidestream sampling kits for
damage prior to use. DO NOT use the sidestream on-airway adapters and
sidestream sampling kits if they appear to be damaged or broken.
0 If the CO2 waveform (Capnogram) appears abnormal, inspect the CO2 airway
adapters and replace if needed.
0 Periodically check the CO 2 /Flow sensor and tubing for excessive moisture
or secretion buildup. Do not use them if there is excessive moisture or exterior
condensation.
0 Electric Shock Hazard: The CO2 Sensor contains no user serviceable parts.
0 Refer service to qualified service personnel. Do not open the sensor cabinet at will,
as electric shock hazard may occur.
0 Place the exhaust vent of the CO2 Sensor in drafty ambient and do not let
anything block the exhaust vent.
0 Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to
have been damaged. Refer servicing to qualified service personnel.
0 DO NOT sterilize or immerse the CO2 Sensor in liquids.
0 Replace the sidestream on-airway adapters and sidestream sampling kits if
excessive secretions are observed.
0 Do not operate the CO2 Sensor when it is wet or has exterior condensation.
0 Monitor the CO2 waveform (Capnogram). If you see changes or abnormal
appearance, check the patient and the sampling line. Replace line if needed.
0 DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min
+/- 10 ml/min from the airway or patients that can not tolerate the added dead

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space to the airway.

0 Do not apply excessive tension to any sensor cable or pneumatic tubing.
0 Explosion Hazard: DO NOT use in the presence of flammable anesthetics or other
flammable gasses. Use of the CO2 Sensor in such environment may present an
explosion hazard.
0 The power voltage over monitor working voltage may cause damage to CO2 sensor.
Likewise, too low power voltage may affect the CO2 measuring accuracy or even
make the CO2 sensor not work.
0 When changing sampling tube, it is suggested to choose the default sampling tube
with dehumidifying function. The sampling tube without dehumidifying function
may be easily blocked by excessive moisture. (Use life: ordinary sampling tube:
6~12 hours; the sampling tube with dehumidifying function: about 120 hours.)
0 If the measurement appears abnormity caused by sampling tube block, please
replace it.
0 The total length of the sampling tube and extending airway tube shouldn’t be
longer than 3 meters, too long may cause measurement abnormity. If using T
connector sampling cannula kits, please insert the sampling tube with the tubes
upward to avoid the affects of excessive moisture;
0 Altitudes are different in different area, so set the Barometric Pressure setting
value as the ambient barometric pressure.
0 Use only our company approved accessories.
0 While using the CO2 sensor, a system leak which may be caused by an uncuffed
endotracheal tube or a damaged CO2 sensor, may significantly affect flow-related
readings. These include flow, volume, pressure and other respiratory parameters.
0 When stopping CO2 monitor, please disconnected the CO2 sensor from the patient
monitor.
☞ Disposal of the CO2 Sensor and its accessories should comply with national and/or local
requirements.
☞ In the presence of electromagnetic devices (i.e., electrocautery), patient monitoring may
be interrupted due to electromagnetic interference. Electromagnetic fields up to 20 V/m
will not adversely affect system performance.
☞ Nitrous oxide, elevated levels of oxygen, helium and halogenated hydrocarbons can
influence the CO2 measurement.
☞ Excessive moisture in the CO2 may affect the accuracy of the flow measurement.

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5.3 CO2 Monitoring Screen

Figure 5.2 CO2 Monitoring Screen

Waveform area
— 5th trace: CO2 waveform. It can be respiration waveform or CO2 waveform.

Data area

Figure 5.3 RR, EtCO2, and Ins Data Area

— “RR”: Respiration Rate: The rpm after that is the unit of the respiration, i.e., respiration per min.
— “EtCO2 39.0”: The label and the value will become gray when CO2 is turned off.
— Ins: The label of the minimal inhalational CO2, the label and the value will become gray when CO2 is
turned off.
— “16”: Respiration rate. It will display the respiration rate of CO2, when the switch is turned on.
— “X1”: Respiration gain（amplification）：
“×1/2” Waveform scaled with half of the base gain.
“×1” Waveform scaled with base gain.
“×2” Waveform scaled with twice of the base gain.
“×4” Waveform scaled with four times of the base gain

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Observing Screen, 7 Leads on the Same Screen and other display screen will display CO2 monitoring data as
well besides Main Screen.

Note: only when the setting item “System Menu→SETUP→CO2→Switch”is set as “ON”, CO2 monitoring
function is available.

5.4 CO2 Graphic Trend

On Graphic Trend screen, rotate the knob and move the cursor to “CO2”, then press the knob to enter EtCO2 Graphic
Trend. Refer to Chapter 6.4 Graphic Trend Screen for detailed instructions and operations.

Figure 5.4 EtCO2 Graphic Trend

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Chapter 6 Operating Instructions for System Menu

6.1 System Menu Screen

Longtime press the “Navigation Knob” in the Main Screen as shown in Figure 4.2, the System Menu screen will
display in the lower left area on the screen, as shown in Figure 6.1.

Figure 6.1 System Menu Screen

6.1.1 How to Select the Menu Item

Step 1: rotate the knob to move the gray cursor to the corresponding item.

Step 2: press the knob to enter the corresponding screen: SpO2 Data List Screen, NIBP Data List Screen, Graphic
Trend Screen, Recall Screen, Arrhythmia Screen, System Setup Screen, Color Settings, File/Archive Management
Screen, oxyCRG Screen, Event List Screen, MC Calculator Screen or Cuff (Tourniquet Function) Screen. The
following chapters will describe each one respectively.

Pressing “ ” key to return to the Main Screen.

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6.2 SpO2 Data List Screen

Figure 6.2 SpO2 Data Listing Screen

6.2.1 Screen Description

When monitoring, the newest data will be displayed on the top of list including “ Time, HR, RR, TEMP, SpO2, PR”.
The time shows the time when the SpO2 measurement was taken. Up to 6 groups of SpO2 data can be displayed on one
screen. There is only one record every 4 seconds.

6.2.2 Operating Instructions

Up to 400 groups of SpO2 data can be memorized. Using the Navigation Knob allows the user to scroll the list up and
down to view SpO2 data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 6, the Navigation Knob can not
be used to scroll up or down the listing.

Pressing “ ” key to return to the Main Screen.

6.3 NIBP Data List Screen

Figure 6.3 NIBP Data List screen

6.3.1 Screen Description

When monitoring, the newest data will be displayed on the top of list including “ Time, NIBP, PR, HR, RR,TEMP”.
The time shows the time when the NIBP measurement was taken. Up to 6 groups of NIBP data can be displayed on
one screen. There is only one record every 4 seconds.
6.3.2 Operating Instructions

Up to 12000 groups of NIBP data can be memorized. Using the Navigation Knob allows the user to scroll the list up
and down to view NIBP data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 6, the Navigation Knob can not
be used to scroll up or down the listing.

Pressing “ ” key to return to the Main Screen.

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6.4 Graphic Trend Screen

Figure 6.4 HR Trend

6.4.1 How to View the Graphic Trend

Figure 6.4 is the HR trend graph. There are 3 options on the right of the graph, as described below.

“HR” indicates the current trend graph is HR trend graph. If you want to enter other trend graphs, the procedures are:
move cursor to “HR” and rotate the “Navigation Knob” to choose the trend graph from “HR”, “S-T”, “Temperature”,
“NIBP”, “PR”, “RR” and “SpO2” trend graphs, next press the knob to confirm. Their screens are described in the
following figures.

After choosing “Cursor”, the trend graph display a triangle and a vertical line, a moving ruler mark that can be moved
by rotating the knob. As shown in the figure, when you move the mark to a specific point, the data area below the
graph will display the time and its corresponding heart rate, respiration rate, SpO2, temperature. When rotating
“Navigation Knob” key to move the mark, the moving interval is a changing value. The rule is that the initial step is
5sec, after moving it towards the same direction 1 time, the interval becomes 30 sec, and with more steps the interval
becomes 1min, 10min and 30min.. Therefore, it is very easy to find the time you are looking for.

The “5 sec” on the top shows the interval time. Move the cursor to the trend time, press the knob and rotate it, and the
trend graph time will change to 30 sec, 1 min, 10 min, 30 min, which changes the horizontal axis to be 30 min, 3 hour,
6 hours, 60 hours, 180 hours. For example, the monitoring can record 360 times data continuously when setting to “5
sec” within 30 minutes. Changing the interval time of 30 seconds, it can record 360 times data within 3 hours. Other
changes are similar to that situation.

The Trend graph shows parameter value of the current time. For example, in the “5 sec” trend graph, the monitoring
can record the current data with the interval of 5 seconds. Once the monitor is out of power, the data can be stored
automatically and you can scan the history record when turning on the monitor next time. This ensures the screen
always display the current data continuously. Other trend graph follows the same rule.

Please note that the maximum value on the vertical axis of the ECG is 150, not the value of ECG upper limit 300. The
graph is scaled down for better view of the waveforms. When the ECG value exceeds 150, the vertical axis’s
maximum value will automatically change to 300. That is to say, the vertical axis value 0-75-150 will change to
0-150-300 automatically if the ECG value exceeds 150. When system gets reset or the patient ID is changed, the
vertical axis will return to its original value of 0, 75, and 150. Other changes of vertical axis value in other trend graph
are similar to that of ECG.

The respiration rate, body temperature and other trend graph are similar to that of ECG’s and we will not cover them
in detail again. Please note that for those trend graphs, the horizontal axis is the number of times the blood pressure
measured instead of time.

NIBP graphic trend is a little different from the other graphic trends. Rotate the knob to move the cursor to
“ ”, then press the knob for activating this item. Next, rotate the knob towards left or right for viewing
another 400 groups’ graphic trend.

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Figure 6.5 S-T Graphic Trend

Figure 6.6 Body Temperature Graphic Trend

Figure 6.7 ETCO2 Graphic Trend

Figure 6.8 SpO2 Trend graph

Figure 6.9 PR Graphic Trend

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Figure 6.10 Respiration Graphic Trend

6.4.2 Operation Instructions

Rotate the Navigation Knob to choose the parameter and press the knob to review the trend graph.

Pressing “ ” key to return to the Main Screen.

6.5 Recall Screen

Figure 6.11 Waveform Recall Screen

It shows the monitoring can recall the history data continuously. If you change the patients’ ID or the monitor is out of
power, the measuring data will not being a new single record, but connect to the last record you have measured. It is a
continuous record.

The ECG lead, gain and other parameters will not change during recall.
Shown in Figure 6.12, it is different from the Main Screen in its 3rd waveform area and the operation area. We will
explain them in detail below.

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Figure 6.12 Recall Listing

6.5.1 Operation Instructions

Rotate the “Navigation Knob” and choose “Recall”, “HIST”, “Delete” or “Exit”. We explain the functions of each
button below.

Recall: Press the Recall and the first record in recall list becomes green. Rotate the knob to choose a record, and press
the knob to recall it. The recalled waveform is displayed on the 3rd channel of the waveform area, as shown in Figure
6.13.

Figure 5.13 Recalled Waveform

Figure 6.13

Rotate the “Navigation Knob” to move forward or backward to review the waveform. Press the “Navigation Knob” to
exit the waveform recall and return to the initial waveform recall screen.

During waveform recall, the system not only displays the current recalled waveform, but also displays the lead status,
gain and filter type of the waveform and time.

HIST: Press the key to shift between the History key and Current key. Press HIST and the recall list on the left
displays the history data list. Press the Current, the recall list on the left side displays the current one. When entering
the recall screen, the system defaults the current one.

Delete: Press this key, and the selected record in the recall list becomes green. Rotate the “Navigation Knob” to
choose the reviewed record that is to be detected, press it, release it 2 seconds later, and then the record is deleted. The
current record cannot be deleted, or system will exit Delete screen.
Exit: Press this key to return to the System Menu screen.

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6.6 Arrhythmia Screen

Figure 6.14 Arrhythmia Screen

6.6.1 Operation Instructions

The structure is similar to recall screen. We will cover each function key below.

Start: This button is used to start and end the system Arrhythmia detection. The default is OFF. When the Arrhythmia
is not ON, the “Learn” key is disabled. Press this key and the system enters learning mode. The Start changes to End.
Press it again to end the learning. When “Learn” key change to yellow from gray, it indicates the learning has finished.
After the Arrhythmia detection is begins, the system will automatically detect the Arrhythmia waveforms. If
Arrhythmia is detected, the Arrhythmia waveform will be displayed in the 3rd ECG channel, shown in Figure 6.14.
When the system get reset or the patient has changed, the Arrhythmia needs to be re-learned.

Learn: Because the Arrhythmia detection is based on the normal ECG waveform at the same speed and same
amplitude, when the patient changes, or the Arrhythmia detection is incorrect, the Arrhythmia needs re-learn. To better
use the learn function, it is recommended to use a good ECG waveform to learn during the monitoring.

View: Press this key, and the selected record in the Arrhythmia list, which is to be reviewed, becomes the green.
Rotate the “Navigation Knob” to choose the record and display the corresponding waveform in the 3rd ECG channel.
Press the knob again to exit.

Exit: press this key to exit the Arrhythmia detection screen and return to the System Menu screen.

During monitoring, if Arrhythmia is detected, the system will alarm. The Arrhythmia alarm is system default and does
not need setup.
During Arrhythmia detection, incorrect detection might occur if the non-ECG waveforms (e.g.; square wave and
triangle wave) appear.
Before start 1mV testing, please turn off the Arrhythmia detection.
During Arrhythmia detection, the Arrhythmia module is very important. The system requires a group of stable ECG
waveforms. If the system detects the Arrhythmia incorrectly, please re-learn Arrhythmia by pressing “Learn” button
and capture correct template.

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6.7 System Setup Screen

Figure 6.15 System Setup

6.7.1 How to Select the System Setup Item

Step 1: rotate the knob to move the gray cursor to the corresponding item.

Step 2: press the knob to enter the corresponding setting screen: System Setup, Printer Setup, ECG Setup, TEMP
setup, CO2 Setup, NIBP Setup, SpO2 Setup, RESP Setup or resuming Default setting. The following contents will be
described each one respectively.

Pressing “ ” key to return to the Main Screen or “Exit” button to return to the System Menu screen.

Note: If you disabled Hi and Lo limit alarm function of parameter monitoring, all the alarms related to its parameter
monitoring will be disabled as well.

6.7.2 Parameter Settings

Step 1: rotate the knob to move the gray cursor to the setting item and press the knob to confirm your selection.

Step 2: rotate the knob to change the setting or modify the setting value.

Step 3: press the knob again to change and repress it to save the setting.

Pressing “ ” key to return to the Main Screen

SYSTEM PARAMETER SETTINGS

Figure 6.16 System Setup

— Type: The object being monitored, this can be selected between Adult and Infant.
Adult: the subject is adult.
Infant: the subject is pediatric.
The default is “Adult”
When changing the patient type, the system will perform the alarm settings, NIBP settings initializations.
Please pay special attention to the patient type before starting the monitoring. It is forbidden to use Adult
type on the pediatric patient, or it can cause serious injury.

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— Mode: Monitor System Menu. The “Real Time” shows the real time waveform, i.e. normal monitoring
state. The “Demo” shows the demo waveforms. In the demo state, all the signals and data are generated
from the patient monitor for demo and testing purpose. The default is “Real Time”.

— LANG: The current language used, which can be selected by the user. There is no default for this setting.
However, the setting can be saved.

— Fill: When the fill setting is ON, the display fills the volume for the SpO2 and Respiration. When it is
OFF, the system displays the line graph. The default is OFF.

— Frze: Pressed the key to freeze the selected waveform. The options are “All” and “ECG”. When ECG is
selected, the system only freezes the ECG waveform. When “All” is selected, the system freezes all the
waveforms including ECG, SpO2, and Respiration. The factory default is “ECG”

— Disp2: The Display 2. Two options: Obsev (Observation) and 7 ECG (7 ECG lead) can be selected. The
factory default is Observation.

— AlmVol: The alarm sound volume. The maximum volume is 7 and minimum is 0, i.e. no sound. When
the setting is “0”, the icon “ ” will be displayed on screen to remind user that the alarm sound is off
and Alarm Silence function is disabled. The default is 5.

— Beep: If the setting is ON, the press of the button will generate a keystroke sound. The factory is ON.

— Exit: return to the System Setup screen.

PRINTER SETUP

— Printer: For switch on or off the printer.

— Timer: If printer is ON, rotate navigation knob to set on the Timer to enable timed print, and set the
value of printing intervals in the cycle category. When the time is reached, the system will automatically
take the record. The interval is 1,2,3…….to 240 minutes.

— Wav2: When printer is selected, you can choose SpO2, respiration, I, III, AVR, AVL, AVF or V to be
printed with II-lead ECG waveform. The default is SpO2

— ARR: Arrhythmia trigging print. “ON” means the printer will trig once arrhythmia occurs and record
the arrhythmia waveform information. The initial setting is “OFF” means closing the arrhythmia
trigging record.

— Exit: return to the System Setup screen.

☞ Printer is optional function. If the purchased machine has printer, please refer to above Printer
Setup.

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ECG PARAMETER SETTINGS

Figure 6.17 ECG Setup

— Lead: Can choose from I, II, III, AVR, AVL, AVF, V (V1-V6). The default is I.

— Gain: The ECG gain, 6 options x1/4, x1/2, x1, x2, x4 and Auto. Auto is for automatic gain control. The
factory default is x1

— HR Hi: High limit of heart rate alarm

Lo: Low limit of heart rate alarm

The adjustable range and the factory default value can be found in chapter 12.2
— Speed: ECG waveform sweeping speed. 4 options: 6.25, 12.5, 25, 50 mm/s. The factory default is 25
mm/s

— Mode: ECG filter mode. Three options: MON, DIA, and OPE

MON: Monitoring mode. Moderate filtering, it can filter out interference and present good ECG
waveforms.
DIA: Diagnosis mode. No filtering, represent the true ECG without filtering.
OPE: Operation mode. Deep filtering, it can filter out strong interference.
The factory default is MON.
— 1mV: Generating the 1mV signal. This signal is used to test the function of the machine. It is not used
during normal operation. Factory default is OFF
— Notch: frequency filter. Different hardware configuration may make its options various. One is “ON”/
“OFF” (The factory default is ON.), and it means turn on or turn off the 50Hz frequency filter. The
other option is “OFF”/ “50 Hz”/ “60 Hz”, please choose “50 Hz” or “60 Hz” frequency filter according
to your power supply frequency. The factory default is “50 Hz”.
— Pace: Cardiac pacemaker detection. When Pace is “ON”, a mark will be displayed on the ECG
waveform if the patient fitted with a cardiac pacemaker. The factory default is OFF.

— Grid: The grid on the background for Observing Screen and Frozen & S-T Analysis Screen. Factory
default is OFF.
— Exit: return to the System Setup screen.

☞ Limits setup: Move the gray cursor to the High or Low limits of the alarm settings, and press the
“Alarm silence” key to turn ON or OFF the alarm for the setting. Yellow color shows ON status, and
gray color shows the OFF status.

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TEMPERATURE PARAMETER SETTINGS

Figure 6.18 Temperature Setup

— TEMP Hi: High limit of temperature alarm

Lo: Low limit of temperature alarm
NIBP PARAMETER SETTINGS

Figure 6.20 NIBP Setup

— Unit: The pressure unit, and mmHg and kPa can be selected. The factory default is mmHg.

— Mode: The cuff inflation mode, manual or automatic. The factory default is manual. The operator needs
to press the NIBP button to perform NIBP measurement. If the Auto mode is chosen, the operator needs
to set an interval cycle as well.

— Cycle: The inflation interval when the NIBP measurement is set to Auto. The options are STAT, 1 min,
2 min…240 min. Press NIBP and the system begins to count down. It takes blood pressure
measurement automatically after finishing counting down If STAT is selected, press NIBP to take 5
minutes’ measurement.
 WARNING: STAT can only be used for Adult. Using this mode to Infant patient can
cause serious injury.
— NIBP Cali: It is used to check the accuracy of pressure measuring system within NIBP module, which
should be conducted by technicians in test house or service department. There are three options: “Mode
1”, “Mode 2” and “OFF” available. After the verification, it is necessary to make sure it is in “OFF”
status again, or other operations can’t be carried out and NIBP key will be inactivated. Factory default
status is “OFF”.
— Gas Leak: it is used by technicians to perform a leakage inspection for NIBP pneumatic system.
— SYS Hi/Lo: High and Low limits of systolic pressure alarm
— DIA Hi/Lo: High and Low limits of diastolic pressure alarm
— MAP Hi/Lo: High and Low limits of MAP alarm
— PR Hi/Lo: High and Low limits of PR alarm
— Initial inflation pressure setting: Cuff pressure to be inflated initially, its options are different
depending on patient type.
for neonate: initial inflation pressure can be: 60, 70, 80mmHg, default setting: 70 mmHg;

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for infant: initial inflation pressure can be: 80, 100, 120, 140 mmHg, default setting: 100 mmHg;
for adult: initial inflation pressure can be: 80, 100, 120, 140, 160, 180, 200mmHg, default setting: 150
mmHg.

— Exit: return to the System Setup screen.

SPO2 PARAMETER SETTINGS

Figure 6.21 SpO2 Setup

— SpO2 Hi/Lo: High and Low limits of SpO2 alarm

— Pulse Hi/Lo: High and Low limits of pulse rate alarm

— Exit: return to the System Setup screen.

RESPIRATION PARAMETER SETTINGS

Figure 6.22 Respiration Setup

— Gain: Respiration amplification/gain, 4 options, x1/2, x1, x2, and x4. The default is x2

— Speed: Respiration display speed, 2 options 6.25mm/s and 12.5 mm/s. The default is 12.5 mm/s

— Apnea: The apnea alarm time (in second). When the patient stop breathing for the time longer than the
set period, the Respiration display channel display warning “Apnea xxx second”.

— Type: Respiration impedance

— RR Hi: High limit of respiratory rate alarm

— Lo: Low limit of respiratory rate alarm

— Exit: return to the System Setup screen.

RESUME DEFAULT
In the System setup screen as shown in Figure 6.15, rotate knob to choose “DEF” and then press the knob, all the
value of parameters will resume default setting.

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6.8 Color Settings

Figure 6.23 Color Setup

6.8.1 How to Change the Parameter Color

Step 1: rotate the knob to move the gray cursor to the setting item and press the knob to confirm your selection.

Step 2: rotate the knob to choose the color.

Step 3: press the knob again to confirm the chosen color.

Pressing “ ” key to return to the Main Screen or “Exit” button to return to the System Menu screen.

6.9 File Management Screen

Figure 6.24 Document management screen

6.9.1 How to Add a New Patient

The document/archive management screen can be used to manage information about the patient. In the screen, the
operator can enter and modify the patient ID, Name, Bed number, Sex, and Age. The operator can also choose to save
the patient data in the permanent storage. The screen is shown in Figure 6.24.

ID: Or Patient ID. To enter patient ID, choose the patient ID field by using the “Navigation Knob”. Press it to
enter the text entry box. Rotate the knob to choose the letter and press the knob to enter the letter. To delete the
letter, move the cursor to the letter and rotate the knob to enter spaces (after the H). Use the spaces to replace the
letters. After finishing entering the patient ID, choose “Exit” button and press the knob to exit the text entry. The
patient ID is the unique identifier for the patient. When the patient ID changes, the system considers the patient
has changed.
Name: Enter the patient’s name.

Bed: Enter the bed number.

Sex: Choose between M or F for male and female.

Age: Choose the age field and use the “Navigation Knob” to select an age.

Save: The operator can choose how much of the data that needs to be saved. The unit is hour. Once the time is
chosen, the system starts to save data from the current time. If OFF is selected, it means that the data will not be

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saved. The system will determine the time range according to the available disk space. If no disk space available,
SAVE will be displayed as OFF. When the user intends to save the current ECG waveform permanently, please
delete the history files. Refer to Chapter 6.1.1 for deletion methods.

Exit: Press this key to return to the System Menu screen.

6.10 oxyCRG Screen

Figure 6.25 oxyCRG Screen

This screen displays the value or waveform of HR, SpO2, and RESP waveform or Respiration Rate in selected time.

6.10.1 Operation Instructions

Step 1: rotate the knob to move the gray cursor to the button “ ” or “ ” and press the knob to confirm
your selection.

Step 2: rotate the knob to choose the setting. The time can be set as 1 minute, 2 minutes or 4 minutes. The third
channel waveform display can be set as RWAVE (Respiration waveform) or RR (Respiration Rate).
Step 3: press the knob to confirm your setting.

Pressing “ ” key to return to the Main Screen.

6.11 Event List Screen

Figure 6.26 Event List

6.11.1 Screen Description

The Event List displays the time, event type, the value detected and high and low alarm limits. The time shows the
time when the event occurred. Up to 5 groups of event data can be displayed on one screen.

6.11.2 Operating Instructions

Up to 2000 groups of event data can be memorized. Using the Navigation Knob allows the user to scroll the list up and

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down to view event data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 5, the Navigation Knob can not
be used to scroll up or down the listing.

Pressing “ ” key to return to the Main Screen.

6.12 MC Calculator
This monitor supplies 10 kinds of medicine calculation and titration display function.

Figure 6.27 Medicine Dosage Calculator Screen

6.12.1 Medicine Dosage Calculator

Medicine types which can be perform drug dosage calculation: AMINOPHYLLINE, DOBUTAMINE, DOPAMINE,
EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN, and PITOCIN.
Drug Dosage Calculation adopts the following formula:
Medicine Consistency (MC) =Medicine Gross/ Cubage
(Dose/minute)= (Dose/hour) /60
(Dose/Kg/m)= (Dose/m) /Weight
(Dose/Kg/h)= (Dose/h) /Weight
Transfusion Speed (TS) = (Dose/h) /MC
Drop Speed=TS/ (Cubage/drop)
Duration=Medicine Gross/Dose/h）
Formula Introduction： Dose/m=Dose per minute; Dose/h=Dose per hour; Dose/Kg/m=Dose per Kg per minute;
Dose/Kg/h=Dose per Kg per hour.

On medicine calculation screen, at first the operator should move the gray cursor to “Medicine” to select the calculated
medicine name, and then move the cursor to “Weight” to select and confirm patient weight, at this time MC analysis
screen is shown as Figure 6.28

Figure 6.28 MC Analysis Screen

Rotate the Navigation knob to move the cursor to the option which needs to be calculated, press the knob and rotate it
to obtain calculating value. When the calculating value is selected, the calculated value will be displayed in
corresponding position. Each calculating option has limit range, if the result exceeds range, it will display “…”.

 On MC analysis screen, other menu options can not enter value unless entering patient’s weight and

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medicine name again, in default status it is no effective. The values in system is a group of stochastic
initial values, the operator should not consider it as calculating standard, please according to doctor’s
device enter a group values which are suitable for patient.

 The unit of every medicine is settled unit or unit series. The operator must select the appropriate unit
according to doctor’s device. In a unit series, unit carry performs automatic adjustment along with
the current entering value. When exceeding the range of this unit expression, the system will display
“…”.

 When the operator finishes one option entering, the system will give visible indication in menu to
remind operator to check the correctness of entering value.

 For every new entering value, please perform confirming. The operator should take it seriously,
only the entering is correct, the calculating result is believable and reliable.

Select Medicine Type: Move the cursor to “Medicine”, rotate Navigation knob to perform selection. Ten options:
AMINOPHYLLINE, DOBUTAMINE, DOPAMINE, EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE,
NITROGLYCERIN, and PITOCIN. The default medicine is AMINOPHYLLINE.

Weight: when entering into medicine calculating window, the operator should enter patient’s weight; the weight is
used for MC calculation only; weight: 0.5Kg to 300Kg selectable; step: 0.5Kg; default: 70 Kg for adult; 20Kg for
infant.

 Medicine calculation function just supplies a medicine calculator function. The values in table can
have no relation with the monitored patient, so the weight in this menu and the weight in system are
two different values. When update a patient in system operation, the value in this menu will not be
affected.

6.13 Tourniquet Function

Figure 6.29 Cuff

— “Pressure”: when you use Tourniquet function, you need to preset a cuff pressure for hemostasia. The
pressure is adjustable, and its adjusting limit is different depending on patient type:
for neonate: preset range: 70~100 mmHg, default value: “90” mmHg;
for infant: preset range: 80~130 mmHg, default value: “110” mmHg;
for adult: preset range: 80~180mmHg, default value: “140” mmHg.
☞ If the pressure drops down slowly under 10mmHg compared with the preset value due to little air
leakage in the pneumatic system when time passes by, the monitor will re-inflate to maintain the cuff
pressure close to the preset pressure value.
Note: the unit of cuff pressure is the same as the NIBP unit in NIBP Setup.
— “Duration”: After presetting the cuff pressure, you need to set the time period for maintaining the preset
pressure after inflation. “5, 6, 7,…120” minutes adjustable. The default value is “40” minutes.
If the set value is “xx” minutes, the monitor will count down from “xx” minutes automatically when starting
cuff inflation. When time is up, it will deflate automatically.

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— “Alarm”: the alert time is for reminding user that the preset operation of tourniquet is going to end. It can be
chosen from 1 to 60 minutes, and the default value is “5” minutes. If the set value is “xx” minutes and when
counting down time reaches “xx” minutes, the monitor will give off alarm sound until deflation ends. The
alarm type is high priority alarm. (For example: if the duration is 40 minutes and the alert time is 5 minutes,
the alarm will ring to prompt when the duration counts down to 5 minutes. The Prompt Info area starts to
prompt: TOUR C-D 300 seconds. )
— “Start”: shift cursor to “Start” and press “■” key, “Start” becomes “Stop” and meanwhile the blood cuff
starts being inflated; Pressing “Stop” button can stop using this function. After deflation, it will change to
“Start” again.

6.13.1 Operation Instructions

Step 1: rotate the knob to move the gray cursor to the setting item and press the knob to confirm your selection.

Step 2: rotate the knob to change the setting or modify the setting value.

Step 3: press the knob again to change and repress it to save the setting.

Pressing “ ” key to return to the Main Screen or “Exit” button to return to the System Menu screen.

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Chapter 7 Alarm

7.1 Alarm Priority

High Priority:

Over HR limit
Over TEMP limit
Over RR limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit
Over NIBP DIA limit
Over NIBP MAP limit
Over EtCO2 limit
Over InsCO2 limit
Over ST limit
Over NIBP PR limit
ECG VPCEST
Unable to detect HR
Unable to detect SpO2
The battery capacity will exhaust
Medium Priority:
VE RONT
SVE RONT
Lead Off
Probe Off
CO2 Out of Range
Low Priority:
Other arrhythmia phenomenon（Except ECG VPCEST, VE RONT and SVE RONT, refer to 13.3 Abbreviation of
arrhythmia for details.）

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7.2 Alarm modes

When an alarm occurs, the monitor responds with visual alarm indications (which are shown by two ways: alarm
indicator and alarm message description) and audible alarm indications.
Visual Alarm Indicators
The flashing rates for the three categories of alarms are shown in the table below.

Indicator Color Alarm Category Flashing Rate

Red flashing High priority alarm 2 Hz
Orange flashing Medium priority alarm 0.5 Hz
Orange light Low priority alarm Constant(on)(non-flashing)

Table 6.1
Refer to Chapter 13.1 Alarm Information for detailed alarm message descriptions.

Audible Alarm Indications

The audible alarm has different tone pitch and on-off beep patterns for each priority category. These are summarized in
the Table below.
Alarm Category Tone Pitch Beep Rate
High priority alarm ~500Hz 2 beeps per 7 sec.
Medium priority alarm ~700Hz 4 beeps per 9 sec.
Low priority alarm ~600Hz 20 beeps per 13 sec.
Normal ~300Hz continuous
Table 6.2

Note: Visual alarm indicators can not be suspended or removed. Audible alarms may be decreased in volume or
silenced as described in Chapter 5.

7.3 Alarm Silence

Press key to set or activate the system alarm. In the monitoring screen, press “Alarm” to set the alarm timer.
There are four options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and 20 minutes. The time shows up on
the upper left corner of the screen. When the alarm timer is activated, the system begins to count down. If alarm
occurs during that period, the system alarm will be activated automatically and the monitor will give alarm. If there is
no alarm during that period, when the set time has passed the system alarm will be activated as well.

When the monitor alarms, press key to suspend the alarm and set the alarm silence time.
0 DO NOT silence the audible alarm or decrease its volume if patient safety could be
compromised.

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7.4 Alarm Setting

In the System menu screen, move the cursor to the “SETUP”, and press it to enter System Setup screen.
☞ Limits setup: Move the gray cursor to the High or Low limits of the alarm settings, and press the “Alarm” key to
turn ON or OFF the alarm for the setting. Yellow color shows ON status, and gray color shows the OFF status.

Refer to Chapter 13.2 for detailed Default Alarming Values of All Parameters and Setup Range.

0 Whenever the monitor is used, check the alarm limits to ensure that they are appropriate for
the patient being monitored.

7.5 Verify Adjustable Alarm Function

To verify adjustable alarm function, select “Demo” for the item of Mode in system parameter settings menu and adjust
alarm limits or change alarm setting, then pay a close attention to the alarm. If the alarm is sent out according to your
setting, it means the alarm function is effective.

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Chapter 8 Technical Specifications

8.1 ECG Monitoring

1. Input signals range in amplitude: ± (0.5 mVp ~ 5 mVp)

2. Heart rate display range: 15 bpm ~ 350 bpm
3. Heart rate display accuracy: ± 1% or ± 2 bpm, whichever is greater.
4. Heart rate averaging: Averages the recent eight beats having RR intervals falling within the acceptable limits.
5. Heart rate alarm delay time: ≤ 10s
6. Response time to change in heart rate:
Change from 80 bpm to 120 bpm: < 8 sec
Change from 80 bpm to 40 bpm: < 8 sec
7. Tall T-wave rejection: Rejects all T-wave less than or equal to 120% of 1mV QRS.
8. Pacemaker pulse rejection:
Rejects all pulses of amplitude ± 2mV to ± 700mV and duration 0.1 to 2 ms without overshoot;
Rejects all pulses of amplitude ± 2mV to ± 400mV and duration 0.1 to 2 ms with overshoot.
9.Sensitivity selection:
AUTO, Automatic scaled waveform
×1/4, 2.5mm/mV tolerance: ± 5%
×1/2, 5mm/mV tolerance: ± 5%
×1, 10mm/mV tolerance: ± 5%
×2, 20mm/mV tolerance: ± 5%
×4, 40mm/mV tolerance: ± 5%
10. Sweeping speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s tolerance: ±10%
11. ECG noise level: ≤ 30μVP-P.
12. ECG input loop current: ≤ 0.1μA
13. Differential input impedance: ≥ 5MΩ
14. Common-mode rejection ratio (CMRR):
Diagnostic mode: ≥ 90dB
Operation, monitoring mode: ≥ 105dB
15. Time constant:
Monitoring mode: ≥ 0.3s Diagnostic mode: ≥ 3.2s

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16. Frequency response:

Monitoring mode: 0.67 Hz～40 Hz(＋０．４ｄＢ
－３．０ｄＢ)
Diagnostic mode: 0.05 Hz～150 Hz(＋０．４ｄＢ
－３．０ｄＢ)
Additional declarations to conform the particular standard of IEC 60601-2-27 “Medical
electrical equipment – Part 2-27: Particular requirements for the safety, including essential
performance, of electrocardiographic monitoring equipment”
Direct current for Applied current less than 0.1 microamperes.
respiration, leads-off
sensing, and active noise
suppression
Response to irregular A1 Ventricular bigeminy-80BPM
rhythm A2 Slow alternating ventricular bigeminy-60BPM
A3 Rapid alternating ventricular bigeminy-120BPM
A4 Bidirectional systoles-90BPM
Time to ALARM for Waveform B1, Amplitude Average Time to Alarm
tachycardia 0.5 mV <8 sec
1 mV <8 sec
2mV <8 sec
Waveform B2, Amplitude Average Time to Alarm
1mV <8 sec
2mV <8 sec
4mV <8 sec

8.2 RESP Monitoring

1. RESP rate measuring range: 0rpm~120rpm
2. RESP rate accuracy: ±5% or ±2 rpm, whichever is greater
3. RESP rate alarm limit setting range: 0rpm~120rpm.
4. Alarm tolerance: ±5% or ±2 rpm, whichever is greater

8.3 TEMP Monitoring

1. TEMP measuring range: 25.0℃~45.0℃
2. TEMP measuring accuracy: ±0.2℃
3. TEMP responding time: ≤150s

8.4 NIBP Monitoring

1. Measuring method: Oscillometric Technique
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg
3. Accuracy of pressure measurement: ±3 mmHg
4. Cuff inflation time: <10 seconds (typical adult cuff)
5. Measurement time on the average: < 90 seconds
6. Air release time while the measurement is canceled: <2 seconds (typical adult cuff)
7. Initial cuff inflation pressure
Adult: 175 mmHg Pediatric: 135 mmHg Neonate: 65 mmHg

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8. Overpressure protection limit

Adult: ≤ 300 mmHg Pediatric: ≤ 240mmHg Neonate: ≤ 150 mm
9. NIBP measurement range:
press（unit） Adult Infant Neonate
SYS mmHg 40~275 40~200 40~135
MAP mmHg 20~230 20~165 20~110
DIA mmHg 10~210 10~150 10~95
10. NIBP accuracy:
Maximal mean deviation: ±5 mmHg
Maximal standard deviation: 8 mmHg
11. Measurement mode: Manual, Auto, STAT

8.5 SpO2 Monitoring

1. Transducer: dual-wavelength LED

Wavelength: Red light: 660 nm, Infrared light: 905 nm.
Maximal optical output power: less than 2mW maximum average
2. SpO2 measuring range: 35%~100%
3. Low perfusion capability: 0.4%~5%
4. SpO2 measuring accuracy: not greater than 3% for SpO2 range from 70% to 100%
*NOTE: accuracy defined as root-mean-square value of deviation according to ISO 9919
5. Low perfusion performance: the declared accuracy is attained when the pulse amplitude modulation ratio is as
low as 0.4%

8.6 Pulse Rate Monitoring

1. Pulse rate measuring range: 30bpm~240bpm
2. Pulse rate measuring accuracy: ±2bpm or ±2%, whichever is greater.

8.7 CO2 Monitoring

1. Technology: Infrared absorption method.
2. Mode of Sampling: Sidestream or Mainstream
3. CO2 Response Time:
Sidestream: <3seconds (including transport time and rise time).
Mainstream: <60ms (rise time)
4. Warm-up Time: Not less than two minutes
5. CO2 measurement range: 0~150mmHg
6. CO2 Accuracy: 0~40mmHg ±2mmHg
41~70mmHg ±5% of reading
71~100mmHg ±8% of reading
101~150mmHg ±10% of reading
*NOTE: Gas temperature at 25°C for Sidestream;
Gas temperature at 35°C for Mainstream
7. Flow rate: 50ml/min ±10 ml/min (Sidestream)

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8.8 Data Recording

1. Sensitivity selection tolerance: ±5%
2. Recording speed: 25mm/s
3. Recording speed accuracy: ±10%
4. Hysteresis: ≤0.5mm
5. Frequency response:
Monitoring mode: 0.5~40Hz Diagnostic mode: 0.05~75Hz
6. Time constant:
Monitoring mode: ≥0.3s Diagnostic mode: ≥3.2s

8.9 Other Technical Specifications

1. Power supply: 100~240VAC, 50/60Hz
2. Power consumption: see the nameplate on the monitor
3. Rechargeable Li-ion battery specification: 14.8V 2200mAh
4. Display mode: 7 inches TFT color LCD Resolution: 800×480pixel
5. Alarming mode: Audible & visible alarm
6. Communication: Serial/Net port

8.10 Classification
Safety standard: IEC 60601-1
The type of protection against electric shock Class I equipment.
The degree of protection against electric shock Type BF and CF applied parts
Electro-Magnetic Compatibility: Group I, Class A
The degree of protection against harmful ingress Ordinary equipment without protection against
of water ingress of water.
Not suitable to use in the environment where
The safety degree of flammable gas
flammable gas exits.

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8.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility

Table 1
Guidance and manufacturer’sdeclaration-electromagnetic emission- for all
EQUIPMENT AND SYSTEMS

Deluxe-70 Patient Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the equipment or system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment-guidance

RF emissions Deluxe-70 Patient Monitor uses RF energy only for its

CISPR 11 internal function. Therefore, its RF emissions are very low
Group 1
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions Deluxe-70 Patient Monitor is suitable for use in all
CISPR 11 Class A establishments other than domestic and those directly
connected to the public low-voltage power supply network
Harmonic emissions
that supplies buildings used for domestic purposes.
IEC61000-3-2 Class A

Voltage
fluctuations/flicker
Complies
emissions
IEC61000-3-3

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Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity
for all EQUIPMENT AND SYSTEMS

Deluxe-70 Patient Monitor is intended for use in the electromagnetic environment specified below. The customer
or the user of the equipment or system should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC60601 test level Compliance level
-guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete
discharge(ESD) ±8kV air ±8kV air or ceramic tile. if floors are
IEC61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%
Electrical fast ±2kV for power ±2kV for power Mains power quality should be
transient/burst Supply lines Supply lines that of a typical commercial or
±1 kV for ±1 kV for hospital environment.
IEC61000-4-4 input/output lines input/output lines

Surge ±1kV line (s) to line(s) ±1kV differential Mains power quality should be
IEC 61000-4-5 ±2kV line(s) to earth mode that of a typical commercial or
±2kV common hospital environment.
mode
Voltage dips, short Mains power quality should be
interruptions and voltage that of a typical commercial or
variations on power hospital environment. If the user
supply input lines of the equipment or system
IEC61000-4-11 requires continued operation
during power mains interruptions,
it is recommended that the
equipment or system be powered
from an uninterruptible power
supply or a battery.

Power Power frequency magnetic fields

frequency(50Hz/60Hz) should be at levels characteristic of
magnetic field a typical location in a typical
3A/m 3A/m
IEC61000-4-8 commercial or hospital
environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity-for
EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Deluxe-70 Patient Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of Deluxe-70 Patient Monitor should assure that it is used in such an electromagnetic
environment.
Compliance
IMMUNITY test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part of
Deluxe-70 Patient Monitor, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF 3V
Recommended separation distance
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz

Radiated RF 3 V/m
IEC 61000-4-3 3 V/m
80 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey ,a
should be less than the compliance level in each
frequency range .b
Interference may occur in the vicinity of
equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and
electromagnetic site survey should be considered. If the measured field strength in the location in which
Deluxe-70 Patient Monitor is used exceeds the applicable RF compliance level above, Deluxe-70 Patient
Monitor should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating Deluxe-70 Patient Monitor.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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Table 4
Recommended separation distances between portable and mobile RF
communications equipment and The equipment or system-
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Deluxe-70 Patient Monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the equipment or system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the equipment or system as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum m
output power of 150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz
transmitter
W

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where p is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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Chapter 9 Monitoring Parameter

9.1 ECG Monitoring

9.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value
The electrocardiogram (ECG or EKG) is primarily a tool for evaluating the electrical events within the heart. The
action potentials of cardiac-muscle cells can be viewed as batteries that cause charge to move throughout the body
fluids. These currents represent the sum of the action potentials occurring simultaneously in many individual cells and
can be detected by recording electrodes at the surface of the skin. The figure below shows the system of the heart.

A common ECG plate electrode used together with this monitor has short shelf life. Generally, the shelf life is only one
month after the package is opened. When outdated plate electrode is used, due to skin’s contact impedance and big
electrode potential, the chance of interference will be increased, and the ECG baseline will have an unstable inclination.
Therefore, always use valid plate electrodes.

9.1.2 Factors affecting ECG signal

— Interference from Electrosurgical Unit;
— Doesn’t filter the interference waveform;
— Poor grounding;
— Electrodes are not placed properly;
— Use expired electrode or use disposable electrode repeatedly;
— The skin placed electrode is unclean or poor contract caused by scurf and hair;
— Electrode long-time used.

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9.2 Respiration Monitoring

9.2.1 Measuring Principle
The air will be filled into alveolus or be expelled during respiration, and the chest’s volume changes with this
process. Because the conductivity of air is lower than body tissues, the chest’s impedance will be changed by the
inflation. With this specialization, the respiration can be monitored through putting safe current into body and
measuring the change of voltage between the electrodes. The product will transmit the high-frequency current
whose frequency is much higher than ECG frequency (but with the safe current limit) to the ECG electrodes
(placed at the both sides of chest), which can be detect ECG signal and chest’s impedance at the same time, and
the respiratory rate will be measured through impedance method by the software. So the additional electrodes for
respiratory measurement are unnecessary.

9.2.2 Factors affecting respiration monitoring

— Place the white (RA) and red (LL) electrodes on the cross, if the line between two electrodes in liver area or
heart area, the artifical error may occur.
— Respiration monitoring doesn’t support monitoring the patient who do much movement, or may lead to
wrong alarm.

9.3 SpO2 Monitoring

9.3.1 Measuring Principle
Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its density or
concentration. When the light with certain wavelength emits on human tissue, the measured intensity of light after
absorption, reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes.
Due to that oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption character in
the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, SpO2 can
be determined. SpO2 measured by this monitor is the functional oxygen saturation -- a percentage of the hemoglobin
that can transport oxygen. In contrast, hemoximeters report fractional oxygen saturation – a percentage of all measured
hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.

9.3.2 SpO2 Measurement Restrictions (interference reason)

— Intravascular dyes such as indocyanine green or methylene blue
— Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared
heating lamps, or direct sunlight.
— Vascular dyes or external used color-up product such as nail enamel or color skin care
— Excessive patient movement
— Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line
— Exposure to the chamber with high pressure oxygen
— There is an arterial occlusion proximal to the sensor
— Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing

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9.3.3 Low SpO2 measuring value caused by pathology reason

— Hypoxemia disease, functional lack of HbO2
— Pigmentation or abnormal oxyhemoglobin level
— Abnormal oxyhemoglobin variation
— Methemoglobin disease
— Sulfhemoglobinemia or arterial occlusion exists near sensor
— Obvious venous pulsations
— Peripheral arterial pulsation becomes weak
— Peripheral blood supply is not enough

9.3.4 Clinical Limitations

— As the measure is taken on the basis of arteriole pulse, substantial pulsating blood stream of subject is
required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use
of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will
be more sensitive to interference.
— For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid
indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin,
and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
— The drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor
blamed for serious error of SpO2 measurements.
— As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia, the
measurement result of some patients with serious anemia may also present as good SpO2 value.

9.3.5 Points to be noted in SpO2 and Pulse Measuring

— The finger should be properly placed (see the attached illustration of this instruction manual), or else it may
cause inaccurate measurement result.
— Make sure that capillary arterial vessel beneath the finger is penetrated through by red and infrared lights.
— The SpO2 sensor should not be used at a location or limb tied with arterial or blood pressure cuff or
receiving intravenous injection.
— Do not fix the SpO2 sensor with adhesive tape, or else it may result in venous pulsation and consequential
inaccurate measurement result of SpO2.
— Make sure the optical path is free from any optical obstacles like adhesive tape.
— Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light,
infrared heater, and direct sunlight etc.
— Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
— Please do not use the SpO2 sensor when having the MRI, or burn may be caused by faradism.
— Always observe the plethysmogram (waveform), which is auto-scaled within the range of 100. The SpO2
reading may be unlikely true when the waveform is not smooth or irregular. If in doubt, rely on your clinical
judgment, rather than the monitor readout.
— A functional tester can not be used to assess the accuracy of the pulse oximeter monitor or a SpO2 sensor.
However, a functional tester, such as SpO2 simulator can be used to check how accurately a particular pulse
oximeter is reproducing the given calibration curve. Before testing the oximeter by a functional tester,
please firstly ask the manufacturer which calibration curve is used, if necessary, request the manufacturer
for its dedicated calibration curve and download it into the tester.

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9.4 Temperature Monitoring

The sensor is thermo-resistor type (25℃ 5kΩ) and is supplied with constant micro current. Calculating the
temperature of measured part through measuring the voltage. There is a period responding time, so the accurate
temperature value display after a while. The temperature monitoring can be divided into two measuring method:
measure through body surface temperature and through the temperature inside the body cavity (placed in mouth or
anus).

Normal value: body surface: 36.5℃~37℃; inside body cavity: 36.5℃~37.7℃

Notes:
¾ Attach the TEMP transducer to the patient; generally if the TEMP transducer and skin doesn’t contact closely,
the measured value becomes lower, so for those who have requirement for temperature, add a proper martial to
transducer and fix it with adhesive tape to make them contact firmly.

¾ Especially for pediatric patient, they like sports, pay more attention to the transducer fixing.

9.5 CO2 Monitoring

9.5.1 Measuring Principle
The principle is based on the fact that CO2 molecules absorb infrared light energy of specific wavelengths, with the
amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a
gas sample containing CO2, the electronic signal from a photodetector (which measures the remaining light energy),
can be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately reflect CO2
concentration in the sample. To calibrated, the photodetector’s response to a known concentration of CO2 is stored in
the monitor’s memory.
The monitor determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these
gases.EtCO2 is display as a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In
addition, a CO2 waveform (capnogram) may be displayed which is a valuable clinical tool that can be used to assess
patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time
interval between detected breaths.

9.5.2 Mainstream vs. Sidestream Sampling

Mainstream CO2 sensors are placed at the airway of an intubated patient, allowing the inspired and expired gas to pass
directly across the IR light path. The major advantages of mainstream sensors are fast response time and elimination of
water traps.
Sidestream CO2 sensors are located away from the airway, requiring a gas sample to be continuously aspirated from
the breathing circuit and transported to the sensor by means of a pump. This type of system is needed for
non-intubated patients.
When using mainstream CO2 sensors, check the window for the patient secretions pooled on periodically. Because that
condition may affect the accuracy of the measurement or even make the sensor not work.
When using sidestream CO2 sensors, there is a water trap or a part of the sampling tube with dehumidifying function.
Please periodically check the flow sensor and tubing for excessive moisture or secretion buildup.

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9.6 NIBP Monitoring

9.6.1 Measuring Principle
Blood pressure may be measured in an invasive way (whereby the sensor will be inserted into blood vessel directly)
or a non-invasive way. The non-invasive way includes several methodologies, such as the Korotkoff Sound Method
and oscillating method. The Korotkoff Sound Method is used as a conventional way, whereby stethoscope is used to
measure the blood pressure. By the oscillating method, an inflation pump will fill the air, and release it slowly. A
computer will record change of the cuff pressure when the air is released. With this record, the blood pressure value
will be determined. First of all, make sure the signal quality judgment by computer meets the requirements of accurate
calculation (such as sudden limb movement or cuff being hit during the measurement). If the answer is negative, give
up the calculation. If the answer is positive, proceed with calculation of the blood pressure value.

As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher than that of human
ears, the oscillating method uses different definitions for measurement of diastolic pressure, mean arterial pressure
and systolic pressure from the Korotkoff Sound Method. When the oscillating method is used, the circuit in the
measuring apparatus will separate the amplitude of the cuff pressure from its change with pulsation. With the
oscillating method, the blood pressure at the maximum amplitude of cuff pressure is defined as the mean arterial
pressure. The blood pressure at amplitude of cuff pressure forward reduced according to proper proportion is defined
as systolic pressure, while the blood pressure at amplitude of cuff pressure backward reduced according to proper
proportion is defined as diastolic pressure. The maximum change of pulse pressure occurs at these two points. They
are equivalent to the point with pulse sound and the point without pulse sound respectively in the Korotkoff Sound
Method.

When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive monitoring method
shall be used.
Comparison between blood pressure measuring methods

To overcome the effect of human hearing variation and air release speed on measurement accuracy when the
conventional Korotkoff Sound Method is used to take measure of blood pressure, people have been dedicated to study
of automatic measurement of blood pressure. By now, automatic blood pressure measuring system based on the
principle of oscillating method is mature. In practice, however, various problems are encountered, such as why the
measures taken by the oscillating method is lower or higher than those taken by Korotkoff Sound Method? Why the
measures are inclined to decline? Why, in some cases, no result is obtained in spite of the inflation actions? Why the
measure values have big discreteness and even abnormal data in some cases? Why the SpO2 waveforms may
disappear suddenly? ...and so on. The following explanations are devised to give the answers.
The Oscillating method vs. the Korotkoff Sound Method

Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good correlation with the
invasive measurement. Notwithstanding, any of the non-invasive blood pressure measurements has its one-sidedness
when it is compared to the invasive measurement. The oscillating method has its advantages over the Korotkoff Sound
Method in less error, higher reliability and stability. Their differences may be reflected in the following aspects.
1. The measures by the Korotkoff Sound Method are liable to effect of human factors. For example, different
people may have different sound judging ability, or different reactivity when listening to heart sound and
reading mercury meter. The air release speed and subjectivity may also affect the judgment. By the oscillating
method, the computation is accomplished by the computer, thus relieving the possibility of effect due to
human factor.
2. With the Korotkoff Sound Method, the measure is taken on the basis of appearance and disappearance of heart
sound. The air release speed and heart rate may have direct effect on the measurement accuracy. It also has the
disadvantages of rapid air release and poor accuracy. In the contrast, with the oscillating method, the

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determination is calculated on the basis of cuff pressure oscillatory waveform envelope, and the air release
speed and heart rate has little effect on the measurement accuracy.
3. Statistics show that, when measuring the hypertension, the measure taken by the oscillating method is likely to
be lower than that taken by the Korotkoff Sound Method. When measuring the hypotension, the measure taken
by the oscillating method is likely to be higher than that by the Korotkoff Sound Method. But, it doesn’t mean
the advantages or disadvantages between the oscillating method and the Korotkoff Sound Method.
Comparison with the results taken by more accurate method, let’s say comparison of the invasive pressure
result with the output value by the blood pressure measuring simulator, will show which method has more
accurate results. In addition, higher or lower value should be a statistical concept. It is recommended those
used to adopt the Korotkoff Sound Method use different physiological calibration for values determined by the
oscillating method.
4. The studies have shown that the Korotkoff Sound Method has the worst accuracy when it comes to
measurement of hypotension, while the oscillating method has worse accuracy when it comes to measurement
of controlled hypertension relief.

9.6.2 Factors affecting NIBP measuring

— Select a cuff of appropriate size according to the age of the subject.
— Its width should be 2/3 of the length of the upper arm. The cuff inflation part should be long enough to
permit wrapping 50-80% of the limb concerned.
Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate
measurement.
Make the cuff mark φ in the position where artery pulsates obviously, the effect will be best.
The lower part of cuff shall 2cm above the elbow joint.
— Do not wrap the cuff on too thick clothes(especially forcotton-padded clothes and sweater ) to take
measurement;
— The testee shall lie in bed or sit in chair, make the cuff and heart at the same level, the result will be most
accurate, other postures may have inaccurate result;
— During measuring, do not move your arm or the cuff;
— The measuring interval shall longer than 2 minutes, in continuous measurement, too short interval may
cause arm extrusion, blood quantity increases, then cause blood pressure increases.
— Keep the patient still and stop talking before and during measuring;
— The patient’s mood also can affect the measuring result, when exciting, the blood pressure goes up.
— The measuring result also affected by time, lower in the morning and higher in the evening;

9.6.3 Clinical Limitations

1. Serious angiospasm, vasoconstriction, or too weak pulse.

2. When extremely low or high heart rate or serious arrhythmia of the subject occurs. Especially auricular
fibrillation will lead to unreliable or impossible measurement.

3. Do not take the measurement when the subject is connected with an artificial heart-lung machine.

4. Do not take the measurement when the subject uses diuresis or vasodilator.

5. When the subject is suffering from major hemorrhage, hypovolemic shock and other conditions with rapid
blood pressure change or when the subject has too low body temperature, the reading will not be reliable, for
reduced peripheral blood flow will lead to reduced arterial pulsation.

6. Subject with hyperadiposis; In addition, statistics show that 37% people report blood pressure difference of no

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less than 0.80kPa(6mmHg) between the left and right arms, and 13% people report difference of no less than
1.47kPa (11mmHg).
Note: Some practitioners may report big discreteness or abnormal value of the blood pressure measures when the
oscillating method is used. As a matter of fact, the so-called “big discreteness” must be a term in the sense of
statistical significance of mass data. Abnormal data may be observed in some individual cases. It is normal in the
scientific experiments. It may be caused by an apparent reason, or by an unknown factor in some cases. Such
individual doubtful experimental data may be identified and eliminated using the special statistical technique. It is
not a part of this manual. The practitioner may eliminate the apparently unreasonable data according to the
experience.

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Chapter 10 Packaging and Accessories

10.1 Packaging
The product is packed in high quality corrugated cartons with foam inside to protect the equipment against damage in
the shipping and handling process.
Gross Weight: Details see the indication on the outer package
Dimension: 355(L) ×245(W) ×245(H) mm

10.2 Accessories
(1) ECG lead One set
(2) NIBP cuff One piece
(3) SpO2 probe One piece
(4) Body surface temperature transducer One piece
(6) AC power adapter One piece
(7) Power code One piece
(8) Li-ion battery One piece
(9) Handle subassembly One set
(10) Disposable electrode Ten pieces
(11) User manual One copy
(12) Warranty One copy
(13) CO2 accessories(optional)

For Mainstream For Sidestream

Mainstream sensor One set Sidestream Sensor One set

( CAPNOSTAT 5 ) (LoFlo C5)
Airway adapter One piece Sampling Line Kit One set

Note: The accessories are subject to change. Detailed items and quantity see the Packing List.

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Chapter 11 Troubleshooting
Note: In case of trouble of this machine in service, follow the instructions below to eliminate the problem first. If the
attempt fails, contact the dealer in your local area or the manufacturer.

 DO NOT open the monitor without permission

11.1 No Display on the Screen

Shut down the machine and unplug the power code. Use a universal meter to check if the outlet has proper voltage, if
the power code is in good condition, and if the power code is properly connected with this apparatus or outlet.
Remove the fuse from the back cover of this machine, and make sure it is in good condition.

11.2 Excessive ECG Signal Interference or Too Thick Baseline

1. Check if the plate electrodes are properly located, and if valid plate electrodes are used.

2. Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires are
broken.

11.3 No Blood Pressure and Pulse Oxygen Measures

1. Check if the blood pressure cuff is properly wrapped around the arm according to the operating instructions, if the
cuff leaks, and if the inlet is closely connected with the NIBP jack on the side panel. Check if the indicator of the
pulse oxygen sensor flashes and if the pulse oxygen probe is properly connected to the SpO2 jack on the side
panel.

2. If the problems still exist, please contact the manufacturer.

11.4 System Alarm

1. When the parameter value is higher or lower than the alarm limits, the alarm will ring. Please check whether the
alarm limit value is proper or the condition of the patient.

2. Leads off. Please check the connection of the leads.

3. Probe off Please check the connection of the probes.

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Chapter 12 Maintenance and Service

Deluxe-70 Patient Monitor should be properly maintained to ensure its maximum performance and long service life. In
addition to the warranty period of one year, the company also offers long-term service for each customer. It is
important that the users read and follow the operating instructions, important information and maintenance measures.

12.1 Technical Maintenances

12.1.1 Daily Examination
Before using the monitor, the checks below should be carried out:
„ Check the monitor for any mechanical damage;
„ Inspect the exposed parts and the inserted parts of all the leads, and the accessories;
„ Examine all the functions of the monitor that are likely to be used for patient monitoring, and ensure that
it is in good working condition;
„ Pay close attention to the fluctuation of the local power supply voltage. A manostat is recommended when
necessary.
In case any indication of damage about the function of the monitor is detected and proven, it is not allowed to apply it
to the patient for any monitoring. Please contact the local dealer or our company, and we are to offer the best solution
as soon as possible for your satisfaction.

12.1.2 Routine Maintenance

After each maintenance or the yearly maintenance, the monitor can be thoroughly inspected by qualified personnel,
including function and safety examinations. The designed life of this monitor is 5 years. In order to ensure its long
service life, please pay attention to the maintenance.
0 If the hospital fails to carry out a satisfactory maintenance program about the monitor, it may get
disabled and harm the patient’s safety and health.
0 In case of ECG leads damage or aging, please replace the lead.
0 If there is any indication of cable and transducer damage or they deteriorate, they are prohibited from
any further use.
 The adjustable units in the monitor such as potentiometer are not allowed to adjust without permission
to avoid unnecessary failures that affect normal application.
 It is recommended to use the battery once a month to ensure its strong power supply capacity and long
service life, and recharge it after run out of the power volume.

12.1.3 Battery Maintenance

0 Please pay attention to the polarity of battery, do NOT insert it into battery compartment with
reversed polarities;
0 Do NOT use the batteries manufactured by other companies, if being inserted, the device will may be
damaged;
0 In order to avoid damaging the battery, do NOT use other power supply device to charge the battery;
0 After battery ageing phenomenon occurring, do NOT throw the battery into fire to avoid explosion
risk.
0 Do not hit or strike it with force;

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0 Do not use this battery on other devices;

0 Do not use this battery below -20℃ or above 60℃;
 In order to maintain battery supply time and prolong battery lifetime, please charge the battery
periodically. Generally, charge the battery every 3~6 months and 2~5hours each time. When the
battery power is full, battery power indicator displays full grid. Before storage, please discharge the
battery until it remains 80% power. Do not use the AC power adapter and power code not purchased
from the manufacture.
 Whether the monitor is on or off, the built-in battery will be charged as long as the monitor is
connected to an AC outlet. When the battery is full, it will stop charging for protecting from damage.
If the monitor is connected to an AC outlet and turned on, it will use AC power, but when AC power is
cut off, the DC power will be used. Priority of using AC power and power shift between AC and DC
are automatically and uninterrupted.
 If the battery is damaged, please change it. The model and specifications of the new battery should be
the same as the original battery. The user must ensure that the battery meets all applicable safety
codes. The user can also contact the local dealer for service.

12.2 Cleaning, Sterilization and Disinfection

 Switch off the monitor and disconnect the power code before cleaning.
 Kept the monitor from dust.
 It is recommended to clean the outer shell and screen of the monitor to keep it clean. Only
non-corrosive cleanser such as clear water is permitted.
 Wipe the surface of the monitor and transducers with an alcohol impregnated wipe, and dry it with
dry and clean wipe or simply air-dry.
 The monitor can be disinfected and sterilized. Please clear the monitor first.
 Do not let the liquid cleanser flow into the connector jack of the monitor to avoid damage.
 Clean the exterior of the connector only.
 Dilute the cleanser.
 Do not use scrub materials.
 Do not let any liquid flow into the shell or any parts of the monitor.
 Do not let the cleanser and disinfectant stay on its surface.
 Do not perform high pressure sterilization to the monitor.
 Do not put any parts of the monitor or its accessories in the liquid.
 If the monitor is accidentally wetted it should be thoroughly dried before use. The rear cover can be
removed by qualified service technician to verify absence of water.
 Do not pour the disinfector on its surface while sterilization.

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12.3 Cleaning, Sterilization and Disinfection of Accessories

It is recommended to clean the accessories (including sensor, leads and plugs) with a piece of gauze which has been
soaked in 75% Alcohol or 70% Ispropanol before using.
0 Do not use damaged accessories.
0 Accessories cannot be entirely immerged into water, liquor or cleanser.
0 Do not use radial, steam or epoxyethane to disinfect accessories.
0 Do wipe off the remained alcohol or ispropanol on the accessories after disinfection, for good
maintanance can extend the life of accessories.

12.4 Storage

If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging, which shall be
kept in a dry and good ventilation place free from dust and corrosive gases.
Storage environment: ambient temperature: -20~60°C
relative humidity: 10%~90%
atmospheric pressure: 53 kPa~106kPa

12.5 Transportation

This monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms. Do not
hit or drop it with force.

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Chapter 13 Appendix

13.1 Alarm Information

Alarm Information Descriptions

Over HR limit
Over TEMP limit
Over RR limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit The related parameter value exceeds the preset high/low alarm
Over NIBP DIA limit limit.
Over NIBP MAP limit
Over ST limit
Over NIBP PR limit
Unable to detect HR ECG cable and leads are connected to monitor and patient well,
but HR is unable to be detected. It may caused by inconformity
HR signal.
Unable to detect SpO2 SpO2 probe is connected to monitor and patient well, but SpO2 is
unable to be detected. It may be caused by inconformity SpO2
signal.
The battery capacity will exhaust Low battery voltage
Lead Off The ECG electrodes or cable fell off
Probe Off SpO2 probe fell off

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13.2 Default Alarming Values and Setup Range

The default alarming value:

Mode Adult Infant Neonate

Parameter
High limit 180 bpm 200 bpm 220 bpm
Heart Rate
Low limit 40 bpm 50 bpm 50 bpm
High limit 40 rpm 50 rpm 60 rpm
Respiration
Low limit 10 rpm 10 rpm 10 rpm
High limit 39℃ 39℃ 39℃
Temperature
Low limit 35℃ 35℃ 35℃
High limit 180 mmHg 130 mmHg 110 mmHg
Systolic
Low limit 60 mmHg 50 mmHg 50 mmHg
High limit 120 mmHg 90 mmHg 90 mmHg
NIBP Diastolic
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 160 mmHg 110 mmHg 100 mmHg
MAP
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 100% 100% 100%
SpO2
Low limit 90% 85% 85%
High limit 180 bpm 200 bpm 220 bpm
Pulse Rate
Low limit 40 bpm 50 bpm 50 bpm
High Limit +1.00mV +1.00mV +1.00mV
ST Segment
Low Limit -1.00mV -1.00mV -1.00mV
Temperature Difference Range 2℃ 2℃ 2℃
High limit 200mmHg 160mmHg 140mmHg
SYS
Low limit 10mmHg 10mmHg 10mmHg
Arterial High limit 200mmHg 160mmHg 140mmHg
DIA
Pressure Low limit 10mmHg 10mmHg 10mmHg
High limit 200mmHg 160mmHg 140mmHg
MAP
Low limit 10mmHg 10mmHg 10mmHg
High limit 120mmHg 100mmHg 90mmHg
SYS
Low limit 10mmHg 10mmHg 10mmHg
Pulmonary High limit 120mmHg 100mmHg 90mmHg
Artery DIA
Pressure Low limit 10mmHg 10mmHg 10mmHg
High limit 120mmHg 100mmHg 90mmHg
MAP
Low limit 10mmHg 10mmHg 10mmHg
High limit 30mmHg 30mmHg 30mmHg
SYS
Low limit 0mmHg 0mmHg 0mmHg
Central High limit 30mmHg 30mmHg 30mmHg
Venous DIA
Pressure Low limit 0mmHg 0mmHg 0mmHg
High limit 30mmHg 30mmHg 30mmHg
MAP
Low limit 0mmHg 0mmHg 0mmHg
Respiration High limit 40 rpm 50 rpm 60 rpm
Rate Low limit 10 rpm 10 rpm 10 rpm
High limit 70 mmHg 70 mmHg 70 mmHg
CO2 EtCO2
Low limit 10 mmHg 10 mmHg 10 mmHg
High limit 10 mmHg 10 mmHg 10 mmHg
InsCO2
Low limit 0 mmHg 0 mmHg 0 mmHg

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The high and low limits setting range:

Mode Adult Infant Neonate

Parameter
High limit 1~350bpm 1~350bpm 1~350bpm
Heart Rate
Low limit 0~349bpm 0~349bpm 0~349bpm
High limit 1~120rpm 1~150rpm 1~150rpm
Respiration
Low limit 0~119rpm 0~149rpm 0~149rpm
High limit 0.1~60°C 0.1~60°C 0.1~60°C
Temperature
Low limit 0~59. 9°C 0~59. 9°C 0~59. 9°C
High limit 31~280 mmHg 31~200 mmHg 31~135 mmHg
Systolic
Low limit 30~279 mmHg 30~199 mmHg 30~134 mmHg
High limit 11~232 mmHg 11~150 mmHg 11~100 mmHg
Diastolic
Low limit 10~231 mmHg 10~149 mmHg 10~99 mmHg
High limit 21~242 mmHg 21~165 mmHg 21~110 mmHg
Mean
Low limit 20~241 mmHg 20~164 mmHg 20~109 mmHg
High limit 1~100% 1~100% 1~100%
SpO2
Low limit 0~99% 0~99% 0~99%
High limit 1~300bpm 1~350bpm 1~350bpm
Pulse Rate
Low limit 0~299bpm 0~349bpm 0~349bpm
High Limit -2.49Mv~+2.49mV -2.49mV~+2.49mV -2.49mV~+2.49mV
ST Segment
Low Limit -2.49mV~+2.49mV -2.49mV~+2.49mV -2.49mV~+2.49mV
Temperature Difference 0.0~5.0℃ 0.0~5.0℃ 0.0~5.0℃
High limit （1~250）mmHg (1~250)mmHg (1~250)mmHg
Systolic
Low limit （0~249）mmHg (0~249)mmHg (0~249)mmHg
Arterial High limit （1~250）mmHg (1~250)mmHg (1~250)mmHg
Diastolic
Pressure Low limit （0~249）mmHg (0~249)mmHg (0~249)mmHg
High limit （1~250）mmHg (1~250)mmHg (1~250)mmHg
Mean
Low limit （0~249）mmHg (0~249)mmHg (0~249)mmHg
High limit （1~120）mmHg (1~120)mmHg (1~120)mmHg
Systolic
Low limit （0~119）mmHg (0~119)mmHg (0~119)mmHg
Pulmonary High limit （1~120）mmHg (1~120)mmHg (1~120)mmHg
Artery Diastolic
Pressure Low limit （0~119）mmHg (0~119)mmHg (0~119)mmHg
High limit （1~120）mmHg (1~120)mmHg (1~120)mmHg
Mean
Low limit （0~119）mmHg (0~119)mmHg (0~119)mmHg
High limit （-9~40）mmHg (-9~40)mmHg (-9~40)mmHg
Systolic
Low limit （-10~39）mmHg (-10~39)mmHg (-10~39)mmHg
Central High limit （-9~40）mmHg (-9~40)mmHg (-9~40)mmHg
Venous Diastolic
Pressure Low limit （-10~39）mmHg (-10~39)mmHg (-10~39)mmHg
High limit （-9~40）mmHg (-9~40)mmHg (-9~40)mmHg
Mean
Low limit （-10~39）mmHg (-10~39)mmHg (-10~39)mmHg
Respiration High limit （1~120）rpm (1~150)rpm (1~150)rpm
Rate Low limit （0~119）rpm (0~149)rpm (0~149)rpm
High limit （1~100）mmHg (1~100) mmHg (1~100) mmHg
CO2 EtCO2
Low limit （0~99）mmHg (0~99) mmHg (0~99) mmHg
High limit （1~30）mmHg (1~30) mmHg (1~30) mmHg
InsCO2
Low limit （0~29）mmHg (0~29) mmHg (0~29) mmHg

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13.3 Abbreviation of Arrhythmia

1. ECG TACHY
2. ECG BRADY
3. ECG VPCEST
4. MISS BEAT
5. VE EARLY
6. SVE EARLY
7. VE COUPLET
8. SVE COUPLET
9. VE RUN
10. SVE RUN
11. VE SHORT RUN
12. SVE SHORT RUN
13. VE BIGEMINY
14. SVE BIGEMINY
15. VE TRIGEMINY
16. SVE TRIGEMINY
17. VE INSERT
18. SVE INSERT
19. VE RONT
20. SVE RONT

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13.4 Status/Error during NIBP Monitoring

“Cuff error” —cuff is not wrapped correctly, or is not connected

“Air leak” —Air moving part, tube or the cuff leak air.

“Pressure error” —Unstable cuff pressure or tangled cuff tubing

“Signal weak” —Very weak signal because of the cuff, or the patient has very weak pulse

“Over extent” —The measurement range exceeds 255 mmHg (Infant patient over 135 mmHg)

“Over motion” —The repeated measurement due to moving, excessive noise during the stepping inflation and

measuring pressure and pulse, e.g. during patient shaking motion

“Signal overflow” —Blood pressure amplifier overflow due to excessive movement

“Leak in gas run” —Leaking during the pneumatic device testing

“System error” —Abnormal condition of CPU, such as register overflow, divided by zero

“Adult” —The blood pressure measuring now is in adult mode. In this case, it is not allowed to

monitoring infant patient. Otherwise, there may be serious danger to the infant monitored.

“Infant” —The blood pressure module is now worked in infant measuring mode.
“PROBE OFF” —SpO2 probe fell off
“LEADS OFF” —The ECG electrodes or cable fell off

“LEARNING” —Learning arrhythmia for 15 seconds

“DEMO” —The monitor is displaying the demo waveforms, which are generated by the monitor itself.

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13.5 Status/Error during CO2 Monitoring

Suggested Message/Response Description
“Sensor Over Temp” The sensor temperature is greater than 40 °C.
Make sure sensor is not exposed to extreme heat (heat
lamp, etc.). If error persists, return sensor to factory
for servicing.
“Sensor Faulty” One of the following conditions exist:
Check that the sensor is properly plugged in. Reinsert Source Current Failure,
or reset the sensor if necessary. If error persists, return EEPROM Checksum Faulty,
sensor to factory for servicing Hardware Error

No Parameter Message Barometric Pressure and/or gas compensations have not been
The host must set the Barometric Pressure and set since power on. For CO2 to be calculated with the stated
compensations to clear this error; no user intervention accuracy, these values should be set whenever the sensor is
should be required. plugged in.

“Module in Sleep Mode” This bit is set when sensor has been placed in sleep mode.
“Zero In Progress “ A Module Zero is currently in progress.
One of the following conditions exist:
“Sensor Warm Up”
Sensor under temperature
This error condition is normal at startup. This error Temperature not stable
should clear when the warm up is complete. Source Current unstable
“Check Sampling Line” This error occurs whenever the pneumatic pressure is outside
Check that the sampling line is not occluded or the expected range.
kinked.
“Zero Required” One of the following conditions exist:
To clear, check airway adapter and clean if necessary. Zero Required;
If this does not correct the error, perform an adapter Zero Required: Zero Error
zero. If you must adapter zero more than once, a
possible hardware error may exist.
The value being calculated is greater than the upper CO2 limit
“CO2 Out of Range”
(150 mmHg, 20.0 kPa, or 19.7 %). The maximum value
If error persists, perform a zero. output is the upper CO2 limit.
“Check Airway Adapter” Usually caused when the airway adapter is removed from the
To clear, clean airway adapter if mucus or moisture is sensor or when there is an optical blockage on the windows
seen. If the adapter is clean, perform a Capnostat of the airway adapter. May also be caused by failure to
zero. perform sensor zero to when adapter type is changed.
This is prompted if the CO2 sensor is not ready for a
Capnostat Zero.
If the “Zero Required” and this massage both prompt
The Sensor message both promptone or more of the following conditions
not Ready may exist:
• Breaths detected
• Temperature is not stable
• Source Current unstable
• In sleep mode.
Zero in already progress Normal zero calibration is in already progress.
Zero Fault and Breaths Detected Zero attempted and breaths have been detected in the last 20
seconds.
Zero Ok Zero calibration is successful

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13.6 Typical Pressures and CO2 Readings at Altitudes

Barometric EtCO2 Reading
Altitude
Pressure(mmHg) （%） （mmHg）
0m 760 5 38.0
70m 754 5 37.7
100m 751 5 37.5
200m 743 5 37.1
1500m 641 5 32.0
3000m 537 5 26.8
5000m 420 5 21.0

13.7 Accessories List

Part No. Part Name Remark
15010513 ECG cable
5101-0101310 ECG electrode
15044051 Adult SpO2 Finger clip Sensor
15044038 Adult SpO2 Finger rubber Sensor Optional
15044041 Pediatric SpO2 Finger clip Sensor Optional
15024402 Adult NIBP cuff(25~35cm)
15021402 Small-sized Pediatric NIBP Cuff Optional
15022402 Middle-sized Pediatric NIBP Cuff Optional
15023402 Large-sized Pediatric NIBP Optional
2507-1700010 Handle subassembly
2301-1005055 AC Power Adapter
2903-0000000 Power cord
900093 Net wire
15100420 CO2 Mainstream sensor Optional for
15100410 CO2 Sidestream sensor Optional for

For more information regarding the accessories, please contact your local sales representative or the
manufacturer.

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13.8 Instructions for SpO2 Probe

Instructions for Pediatric SpO2 Finger Clip Sensor
Intended Use
When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for pediatric
patients weighing between 10~40kg.

Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the finger tip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or
is not available, other fingers can be used.
2) Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
3) Spread open the rear tabs of the sensor to provide even force over the length of the pads (B).
4) The sensor should be oriented in such a way that the cable is positioned along the top of the hand (C).
5) Plug the sensor into the
oximeter and verify proper
operation as described in
the user manual.
6) Inspect the monitoring site
every 1~2 hours for skin integrity.
7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings
1) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poor blood perfusion in the finger,
extreme finger sizes or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover
the sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the
ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently
with some patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted
by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.

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Instructions for Adult SpO2 Finger Rubber Sensor

Intended Use
When used with a compatible patient monitor or a pulse oximeter device, this SpO2 sensor is intended to be used
for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients
weighing greater than 50kg.

Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) Hold the sensor with its opening towards the patient’s index finger (A). The sensor should be oriented in
such a way that the sensor side with a finger tip sign is positioned on the top.
2) Insert the patient’s index finger into the sensor until the fingernail tip rests against the stop at the end of the
sensor. Adjust the finger to be placed evenly on the middle base of the sensor. Direct the cable along the top
of the patient’s hand. Apply adhesive tape to secure the cable (B). If an index finger cannot be positioned
correctly, or is not
available, other fingers
can be used.
3) Plug the sensor into the
oximeter and verify
proper operation as
described in the user
manual.
4) Inspect the monitoring site every 1~2 hours for skin integrity.

Cleaning & Disinfection

Unplug the sensor before cleaning or disinfecting. Surface-clean sensor and cable with a soft gauze pad by
saturating it with a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10
bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings
1) This sensor is for use only with compatible patient monitors or pulse oximeter devices. Use of this sensor
with instruments other than compatibles may result in improper performance.
2) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger
sizes or improper placement of the sensor.
3) The sensor site must be checked for skin integrity at least every 1~2 hours. Because individual skin condition
affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor to another
finger.
4) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted
by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse. Do not use the
sensor during MRI scanning.
5) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
6) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
7) Do not use the sensor if the sensor or the sensor cable appears damaged.

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 User Manual for Patient Monitor

Instructions for Adult SpO2 Finger Clip Sensor

Intended Use
When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients
weighing greater than 40kg.
Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the finger tip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or
is not available, other fingers can be used.
2) Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
3) Spread open the rear tabs of the sensor to provide even force over the length of the pads (B).
4) The sensor should be
oriented in such a way
that the cable is
positioned along the
top of the hand (C).
5) Plug the sensor into the oximeter and verify proper operation as described in the user manual.
6) Inspect the monitoring site every 1~2 hours for skin integrity.
7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Warnings
1) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger
sizes or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover
the sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the
ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently
with some patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted
by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.

Our company offers a 6-momth warranty against manufacturing defects for the SpO2 sensors
mentioned above in its undamaged condition.
If you have any question regarding any of SpO2 sensor instructions, please contact your local dealer.

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Heal Force Bio-Meditech Holdings Group
Nison Instrument (Shanghai) Ltd
Address 15F, No.2 Hua Shan Road, Shanghai 200040, P.R.China
Tel +86 21-6272 8646
Fax +86 21-6271 0529
E-mail export@healforce.com
Website www.healforce.com

Version 1.2
Revised date October 29, 2012