Infinity M300 and M300+ Series: Supplement

Supplement
Infinity® M300 and M300+ Series
WARNING Infinity® M300 and M300+ Series

For a full understanding of the
performance characteristics of this Software VG2.4
device, the user should carefully read
this supplement and the related
instructions for use before use of the
device.
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Supplement – Infinity® M300 and M300+ Series – VG2.4 3

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4 Supplement – Infinity® M300 and M300+ Series – VG2.4

Contents
Supplement Infinity® M300 and M300+ Series VG2.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Infinity® M300/M300+ Indications for use/Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Open-source software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Device symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Infinity M300/M300+ Features for VG2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

QRS Threshold. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
M300/M300+ Arrhythmia processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ECG signal processing and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Patient preparation for ECG monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
ECG precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
ICS Telemetry defaults screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
M300 Demographic screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Alarm settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Infinity M300+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
M300+ front of the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
M300+ swappable battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
M300+ battery charging station for swappable batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Discharging a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
M300/M300+ Performance data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
M300/M300+ accessories overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

M300+ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Pulse Oximetry (SpO2) monitoring with Masimo (for M300/M300+) . . . . . . . . . . . . . . . . . . . . . . . . 37
Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

EMC declaration for M300+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Additional information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Known issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Reprocessing of device-specific components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Classification of medical devices for reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Manual disinfectant and simultaneous cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45


Supplement Infinity® M300 and M300+ Series VG2.4
Supplement Infinity® M300 and M300+ Series VG2.4
This supplement contains the VG2.4 instructions for use for the Infinity M300 and the new Infinity M300+,
that features a swappable battery.
The IFU that ships with this supplement is the Infinity CentralStation Wide SW VG 1.n and Infinity M300.
M300/M300+ Device description
The Infinity M300/M300+ is a patient-worn transceiver that includes a color display, local alarm alerts,
wireless communication technology and is powered by a rechargeable lithium-ion battery. The Infinity
M300/M300+ can be used by healthcare professionals to monitor either adult or pediatric patients (one
patient at a time) in healthcare facilities.
The Infinity M300/M300+ communicates with the Infinity CentralStation (ICS) over the hospital network via
industry standard wireless access points. The ICS display is the primary user interface for M300/M300+
acquired physiological patient data (ECG and SpO2). The Infinity M300/M300+ display, when turned on,
serves as a secondary user interface. The ICS displays and annunciates M300/M300+ audible and visual
alarm signals in real-time.
NOTE
The Infinity M300 is powered by an internal rechargeable lithium-ion battery. The Infinity M300+ is pow-
ered via a rechargeable, swappable lithium-ion battery.
Infinity M300
The standard Infinity M300 includes the following:
 Infinity M300 patient-worn transceiver
 Infinity M300 Bedside Charger
 Infinity M300 Central Charger
 Infinity M300 programming kit
When the patient is sedentary (in bed or sitting) the clinician may attach the Infinity M300 to a bedside
charger, which provides a slow charge to the device. When the Infinity M300 is not in clinical use, it may
be stored and recharged at an accelerated rate in the Central Charger.
Infinity M300+
The standard Infinity M300+ includes the following:
 Infinity M300+ patient-worn transceiver
 Infinity M300+ swappable battery (2)
 Infinity M300+ battery retainer
 Infinity M300+ remote battery charging station (charging capacity of up to 10 swappable batteries)
 Infinity M300+ programming kit

Infinity® M300/M300+ Indications for use/Intended use
When an Infinity M300+ swappable battery is exchanged it can be charged in the M300+ battery charger
to be made ready for later use.
NOTE
TruST 6-wire calculated 12-lead ECG monitoring is optional.
The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry on
ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the
Infinity patient monitoring network.
The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of
electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.
Contraindication
The Infinity M300/M300+ is not compatible for use in an MRI magnetic field.
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical device. See
"Battery safety information" on page 21 for additional safety information.
Warnings:
WARNING
To properly use the M300 and M300+ medical device, read and comply with the latest instructions
for use and this supplement.

WARNING
Inaccurate SpO2 measurements may result under the following conditions:
– Elevated levels of methemoglobin
– Elevated levels of total bilirubin
– Excessive patient motion
– Severe anemia
– Low arterial perfusion
WARNING
Risk of electric shock and device malfunction.
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
Ensure that no liquid penetrates the device.
WARNING
Do not immerse or rinse the device and its peripherals. If you spill liquid on the device (including
the battery or accessories), or accidentally immerse it in liquid, allow contacts to thoroughly dry.
WARNING
Pacemaker considerations
False low-rate alarms can result under the following conditions:
– Asynchronous pacemaker with large amplitude pace pulses with no overshoot and at low
heart rate (30 bpm)
False high-rate alarms can result under the following condition:
– Asynchronous pacemaker with large pace pulse tails and at low heart rate (30 bpm)
Cautions:
CAUTION
Signs of wear, such as cracks, deformation, discoloration, or peeling, may occur with reprocessed
products.
Check the products for signs of wear and replace them if necessary.
CAUTION
To avoid damaging the device, do not use sharp tools or abrasives. Never immerse electrical connectors
in water or other liquids.
CAUTION
Do not autoclave accessories.

Environment of Use
The device is intended to be used in an environment where patient care is provided by healthcare
professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine
when use of the device is indicated, based upon their professional assessment of the patient's medical
condition.
Patient Population
The Infinity M300/M300+ is intended for use with ambulatory and non-ambulatory adult and pediatric
patients, (one patient at a time) excluding infants and neonates, in environments where patient care is
provided by healthcare professionals.
NOTE
Clinical judgment must be used to determine when the M300/M300+ should be used on a specific
pediatric patient. Assigning a specific weight or age to ECG performance is not practical as there are
multiple factors to be considered when making a determination for patient care.
Open-source software
Dräger devices that use software may use open-source software, depending on their setup. Open-source
software may be subject to different terms of license. Additional information regarding the open-source
software used in this device is available at the following web page:
www.draeger.com/opensource

Device symbols
The following table lists the new hardware device symbols displayed on various Dräger hardware.
Symbol Description
Do not re-use, single patient use
Do not re-use
Not made with natural rubber latex
Not made with natural rubber latex
Not made with natural

rubber latex
Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, that ships with this supplement
for additional device symbols.

Infinity M300/M300+ Features for VG2.4
This section contains the Infinity M300/M300+ features for the VG2.4 release. For specific information
about the new M300+, refer to "Infinity M300+" on page 20.
QRS Threshold
Depending on the software versions running on the ICS and the M300/M300+ devices, the procedure you
follow to set the QRS threshold on the M300/M300+ will differ:
 If ICS is VG2.1.1 or later, and the M300/M300+ is VG 2.4 or later, you set the QRS threshold by a menu
selection, either Normal or Low
 If ICS is VG2.1 or earlier, or the M300 is VG2.3 or earlier, the QRS threshold is linked to the ECG gain
and the QRS threshold buttons are greyed out. The following relationships apply:
– Setting the gain to 1, 2, 4, or 8 mV/cm, automatically sets to the QRS threshold to Normal.
– Setting the gain to 0.5 or 0.25 mV/cm, automatically sets the QRS threshold to Low.
NOTE
Patient admitted on M300/M300+ VG2.4:
Changes to QRS/ARR processing leads and gain settings do not change QRS threshold settings.
Patient admitted on M300 VG2.3 and earlier:
– Changes to QRS/ARR processing leads and gain settings will alter the QRS threshold settings be-
tween Normal and Low.
– When selecting one or two QRS/ARR processing leads, a gain setting of < 1mv on either lead, sets
the ICS QRS threshold to Low.
– When selecting one or two QRS/ARR processing leads, a gain setting of > 1mv on all leads, sets the
ICS QRS threshold to Normal.
To set the QRS Threshold using ICS VG2.1.1 and M300/M300+ VG2.4
From the Main ICS screen:
1 Click System setup on the ICS.
2 Click Layouts.
3 Click one of the following:
– Normal to detect QRS complexes of normal amplitude.
– Low to detect QRS complexes of low amplitude.

To set the QRS Threshold using earlier ICS and M300 versions
For ICS 2.1 or earlier, or M300 VG2.3 or earlier, from the Main ICS screen:
1 Click System setup on the ICS.
2 Click Layouts.
3 Click the dropdown arrow of the appropriate Gain/Scale channel.
4 Select the appropriate Gain value:
– Select a value of 1,2,4 or 8 mV/cm to set the QRS threshold to Normal.
– Select a value of 0.5 or 0.25 mV/cm to set the QRS threshold to Low.
QRS detection amplitude
QRS detection amplitude: 0.5 to 5.0 mVp-v RTI

QRS threshold detection duration:
Adult: 70 to 120 ms
Pediatric: 40 to 120 ms
Configuring the QRS threshold to Low may extend the QRS detection amplitude to as low as 0.17 mVp-
v RTI.
WARNING
Risk of inaccurate HR value. If the QRS setting is set to Low in the presence of HR artifact, the
associated HR value may be inaccurate.
To avoid an inaccurate HR value, it is recommended to set the QRS threshold setting to Normal.
ECG QRS processing settings
Gain/Scale column mV/cm Detection threshold

For all ECG waveforms: 0.25, 0.5, 1 (de- 8 >0.35 mV
fault), 2, 4, 8 mV/cm 4 >0.35 mV
The M300/M300+ uses an AAMI-compliant 2 >0.35 mV
regular QRS threshold when you select a
scale of 1, 2, 4, or 8 mV/cm. If you select a 1 >0.35 mV
scale of 0.25 or 0.5 mV/cm, the 0.5 >0.17 mV
M300/M300+ lowers the detection thresh- 0.25 >0.17 mV
old, and the AAMI requirement is not met.

M300/M300+ Arrhythmia processing
Arrhythmias are identified using an internal detection process. This process does the following:
– Filters out ECG signal artifacts
– Detects the beat pattern
– Classifies the beat pattern
– Detects the rhythm
When arrhythmia analysis is enabled, multiple alarm conditions may occur simultaneously. Announcing
all the alarm conditions would cause alarm fatigue and prevent the clinician from addressing the most
serious condition. For this reason, the arrhythmia conditions are prioritized and only the highest priority
alarm event shall annunciate. The priority order of the arrhythmia events is based on the default priority
defined in the algorithm and the alarm grade configured by the user.
Based on this detection process, arrhythmias and other associated events are reported in the following
order of severity:
1 ASY (asystole)
2 VF (ventricular fibrillation)
3 VTACH (ventricular tachycardia)
4 RUN (ventricular run)
5 AIVR (accelerated idioventricular rhythm)
6 SVT (supraventricular tachycardia)
7 CPT (ventricular couplet)
8 BGM (bigeminy)
9 TACH (tachycardia)
10 Brady (bradycardia)
11 Pause (sinus pause)
12 ARR artifact
In addition to storage as events, the two high priority alarms, ASY and VF, are also stored and displayed
in the trends of the ICS.
An arrhythmia with a high grade alarm configuration has a higher priority than an arrhythmia with a
medium, low or disabled alarm grade configuration. An arrhythmia with a medium grade alarm
configuration has a higher priority than an arrhythmia with a low or disabled alarm grade configuration. An
arrhythmia with a low grade alarm configuration has a higher priority than an arrhythmia with a disabled
alarm configuration.
The priority for arrhythmia events configured with the same alarm grade follows the arrhythmia hierarchy
list. When arrhythmia artifact is present (ARTF) at 100% artifact level, no arrhythmia events are
recognized except for bradycardia and ventricular fibrillation. If sinus tachycardia and ventricular
tachycardia are configured at the same alarm grade, a ventricular tachycardia will take priority if the rate
is high enough and the beats are classified as ventricular beats.

ECG signal processing and display
The M300/M300+ calculates heart rates within a range of 15 beats to 300 beats per minute, using the R-
R intervals of the last 10 seconds. This calculation excludes the two longest and two shortest R-R
intervals. The M300/M300+ averages the remaining intervals and displays the result as the current heart
rate in the heart rate parameter box.
During dual-channel processing, a weight is assigned to each channel depending on its level of artifact.
The channel with less artifact always receives the greater weight. When a channel exceeds a certain level
of artifact, it is excluded from the composite signal, and the M300/M300+ shifts to single-channel
processing. If both channels experience excessive artifact, the message ECG artifact appears until at
least one channel is sufficiently free of artifact.
During artifact, asterisks (* * *) replace the heart rate value. When the artifact clears, QRS processing
resumes without initiating a relearning phase.
NOTE
For heart rates of 300 bpm and greater, the monitor may display VF and not the expected +++ as the
parameter value.
Patient preparation for ECG monitoring
The following tips provide optimal ECG monitoring results but must never replace hospital-approved prac-
tices or the recommendations of the electrode manufacturer.
Follow hospital procedures for proper skin preparation. Dräger recommends Ag/AgCl disposable elec-
trodes. Never use disposable electrodes after their expiration date and make sure that there is enough gel
and that the gel has not dried out.
If QRS detection threshold is configured to Low, P- and T-waves with amplitudes exceeding 0.17 mV may
be interpreted as QRS complexes. P- and T-waves with amplitudes exceeding 0.35 mV when QRS detec-
tion threshold is configured to Normal, may be interpreted as QRS complexes. The algorithm has imple-
mented safeguards to reduce the occurrence of P- and T-wave detection as QRS complexes, however
additional steps can be taken to prevent and/or troubleshoot occurrence: .
– To allow detection of low heart rate conditions under these circumstances, place the lead with the high-
est R-wave in ECG Channel number 1.
– If P- and T-waves are misinterpreted, confirm that the lead with highest R-wave is in ECG Channel
number 1 and set QRS detection threshold to Normal.
– If P- and T-waves continue to be misinterpreted, reposition the electrodes or use a pulse oximeter to
monitor the pulse rate.

To maintain a clear signal, change electrodes every 24 to 48 hours or more often when the following
occurs:
– ECG signal degradation
– Excessive patient perspiration
– Skin irritation
Consider the following when selecting electrode sites:
– Surgery – keep electrodes as far from the surgical site as possible, while maintaining a clinically useful
lead configuration.
– Burn patients – use sterile electrodes. Clean the equipment thoroughly and follow hospital infection
control procedures.
ECG precautions
WARNING
Do not rely solely on the ECG when monitoring seizure-prone patients. Electrical artifacts of non-
cardiac origin, such as seizure, may prevent detection of certain arrhythmias.

ICS Telemetry defaults screen
To set the Adult QRS threshold or Pediatric QRS threshold, navigate to the Telemetry defaults screen
and select the Layout/Parameters tab, then the Layout tab.
A B
F C
G H I
A Reduced Main screen showing vital signs in real time

B Main menu bar
C Telemetry Layout Tab page.
D QRS/ARR processing
E QRS/ARR processing channels
F Adult QRS threshold
G Normal
H Low
I Pediatric QRS threshold
J Normal
K Low
Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, for additional screen
descriptions of the ICS interface.

M300 Demographic screens
The Infinity M300 two Demographic screens display patient demographic information. All patient demo-
graphic information is received from the ICS. Use the Up/Down arrows to jump from screen to screen.
Screen 1
A A Name
B ID
B
C Bed label
C D Care unit
D E Patient category
E F F Adult / Pediatric
Use Up and Down arrows to go

from screen to screen.
Screen 2
G G QRS threshold
H
H Normal/Low
NOTE
To display Biomed page from page 2, press the down arrow three times.

Alarm settings
While the battery is attached to the M300+, alarm settings and current patient data remain intact for
approximately 80 hours after the unit powers down due to a depleted battery.
Low battery alarm
When the battery power level has reached approximately 30 minutes of remaining charge, a Low battery
message is reported visually and acoustically at both the ICS and M300/M300+ to indicate that the battery
is low. The M300/M300+ displays the Low battery status once every three minutes, plus or minus five
seconds.
Critical battery alarm
Displays a critical battery alarm message, Recharge battery, to indicate a low battery when the
M300/M300+ power level has reached approximately 15 minutes of remaining charge. The alarm is
reported visually and acoustically at both the M300/M300+ and the ICS. After the user acknowledges the
alarm, the message will rotate through any other displayed M300/M300+ messages.

Infinity M300+
Infinity M300+
This section contains information about the Infinity M300+ for the VG2.4 release.
M300+ front of the device
The following figure shows the M300+ front of the device.
NOTE
Figures of products and screen content in this document may differ from the actual products depending
on configuration and design.
Speaker for acoustic alarm signal
Status LED
- +
Battery charge symbol
Keypad
Battery retainer (see Note below)
Swappable battery pack
Battery release tabs

(one on each side)
NOTE
The battery retainer secures the battery to the M300+, but can be accidentally or intentionally removed.
The battery retainer should always be in place when using the device.

Infinity M300+
M300+ swappable battery
The new Infinity M300+ operates with a swappable, externally rechargeable battery with the following
specifications:
 Battery recharging time of approximately 3.5 hours
 Battery swaps retain clinical data and current alarm settings for approximately two minutes
 Battery swaps do not require tools
 Battery provides a four LED charge level indicator when the battery is detached
 The complete unit, with the swappable battery pack and the battery retainer attached to the
monitor, is rated IPX4, protected against splashing water
WARNING
Do not try to power up the M300+ without a battery installed. Attempting to power up the M300+
without a battery installed will result in erasing any stored patient information from the M300+.
NOTE
IPX ratings:
– Main unit with battery attached is IPX 4, protected against splashing water.
– Main unit without battery attached is IPX 7, protected against temporary immersion.
– Swappable battery alone, unattached, is not IPX rated.
WARNING
During battery replacement, there is no data monitoring and no transmission of data to the ICS.
However, clinical data and current alarm settings are retained in the M300+ for a maximum of two
minutes. Exceeding this time limit will result in loss of clinical data and alarm settings.
Battery safety information
Observe the following warnings and cautions for the swappable battery.
WARNING
Risk if the swappable battery is not replaced properly.
If the swappable battery is not reattached or serviced and replaced properly, short circuits and
high temperatures leading to explosion or fire may occur.

Infinity M300+
WARNING
Risk if the swappable battery contacts are wet.
If the battery is detached or removed for service and the electrical contacts are moistened with
disinfectant, immediately reattaching or reinstalling the battery while the contacts are still wet
could lead to corrosion and contact failure. Dry the contacts before reattaching the battery.
WARNING
Do not crush, drop, or puncture the swappable battery as this could lead to internal damage and
internal short circuits which may not be visible externally.
WARNING
Do not incinerate or expose the swappable battery to high temperatures.
WARNING
Discontinue use of defective or damaged batteries, such as swappable batteries that do not lock
into place on the M300+.
CAUTION
Use M300+ compatible Dräger swappable battery only.
CAUTION
Dispose of swappble batteries in compliance with your institution’s disposal instructions.
Swappable Battery run time on the M300+
M300+ with swappable battery

Typical Battery Run Time Load Conditions
802.11 b/g/n 2.4 GHZ: 22 hours – ECG only
– Display off
802.11 a/n 5 GHz: 22 hours
– Audio off
802.11 b/g/n 2.4 GHZ: 18 hours – ECG
– Continuous SpO2
802.11 a/n 5 GHZ: 18 hours
– Display off
– Audio off

Infinity M300+
Preventive Maintenance
The following table shows the preventive maintenance interval for the M300+ swappable battery:
Component Interval Measure Personnel Responsible

M300+ swappable Every 12 months Replace swappable Users (medical or technical
battery battery personnel)
M300+ battery retainer Every 12 months Replace battery retainer Users (medical or technical
personnel)
Caring for the M300+ lithium-ion swappable battery
The following table provides care instructions for the M300+ swappable battery.
Activity When to Perform

Visually inspect the swappable battery Prior to inserting the swappable battery into the M300+
Clean the swappable battery – When the swappable battery is exposed to contami-
nants
– After each patient discharge
Refer to "Manual disinfectant and simultaneous cleaning"
on page 45 for more information.
Charge stored swappable battery When not in use for an extended time
Replace the swappable battery Once every year.
NOTE
The duration of the swappable battery charge for
the M300+ may be reduced by characteristics of
the wireless environment such as signal quality,
power levels, power-save mode, etc. The battery
operating life can also gradually diminish over
time.
Charge status for swappable battery attached to the M300+
The M300+ LED indicates battery charge status as follows:
LED Battery charge status

Blinks green every 5 seconds Power on
Blinks amber every 5 seconds Low battery charge

Infinity M300+
To remove the swappable battery from the M300+
1 Grip the sides of battery retainer and slide up to remove the retainer.
2 Press the two buttons on each side of the swappable battery.
3 Pull down to remove the battery.
Grip retainer and slide up to remove
MS34702 - 02
M300+
Battery
retainer
Battery
Press buttons and pull down to remove the battery

Infinity M300+
To check the charge status on the swappable battery
When you press the TEST button on the M300+ swappable battery, the battery LEDs light to indicate the
battery charge status . Each lit LED indicates a charge percentage, as described below.
Charge Indicator Lights

1 2 3 4 Connector Contacts
4 LEDs indicates a 90-100% charge
TEST button
1 LED indicates a 11-37% charge
Note: When the charge is less than 11%,

one LED will blink.

Infinity M300+
To insert the swappable battery into the M300+
1 Press the buttons on the swappable battery.

2 Align and insert the battery into place.
3 Slide the battery retainer down over the M300+ into place above the battery.
NOTE
Make sure the swappable battery correctly aligns with the M300+ before securing into place.
Grip retainer and slide down into place
MS34708-XX
Press buttons, align and insert the battery into place
CAUTION
When inserting the swappable battery, carefully align the battery with the bottom of the monitor and press
firmly from the bottom of the battery to avoid pinching fingers when the battery snaps into place. Ensure
any objects or potential obstructions are clear before attaching the battery.

Infinity M300+
M300+ battery charging station for swappable batteries
The wall-mountable or counter top M300+ battery charging station recharges up to 10 M300+ batteries at
a time. Contact your service representative for the wall mounting installation instructions.
Approximate charging time is 10 batteries within 4 hours. The charging station provides auto shut off to
prevent overcharging, and indicates charging status through illuminated LEDs.
The following figure displays an illustration of the M300+ battery charging station. When the charging
station is plugged into an AC outlet, a green LED indicator on the front of the unit is illuminated. Amber
LEDs indicate a battery is charging and green LEDs indicate the battery is fully charged.
These LEDs are green and These LEDs are amber and This LED is green and
illuminated when a battery is illuminated when a battery is illuminated when the battery
connected to power and fully connected to power with a charger is plugged in.
charged at 100%. charge level less than 100%.

Infinity M300+
Inserting the swappable battery into the charger
1 After removing the swappable battery from the M300+, insert it into the charging station.
2 Press the battery into place.
Removing the swappable battery from the charger
1 Press the two tabs on each side of the swappable battery.

2 Pull the battery up to remove.

Infinity M300+
Discharging a Patient
CAUTION
Failure to discharge previous patient information can result in the mixing of patient archive data at ICS
when admitting a new patient using the ICS or the M300/M300+.
Patient discharge occurs from the ICS as well as from the M300+. To discharge a patient from the M300+
screen, do the following:
1 On the M300+ keypad, press the Staff alert setting key and the Alarm pause setting
key simultaneously for 3 seconds.
A confirmation screen appears asking to Confirm discharge of the patient or to Cancel and not
discharge the patient.
2 To discharge the patient, use the up and down arrows on the keypad and select Discharge.
3 Press the Views key to confirm that the patient was discharged.
Refer to the IFU, Infinity CentralStation Wide SW VG1.n and Infinity M300 for the steps to admit a patient
using the M300.

Infinity M300+
Technical specifications
Infinity M300+
Infinity M300+ specifications

Physical specifications
Size, H x W x D with battery 157.5 mm x 81.1 mm x 30.6 mm (6.2 in x 3.19 in x 1.2 in)
attached
Weight 310 g +/- 5g (10.93 oz)
Cooling Convection
Connections ECG, communication port for SpO2, programming cable
Environmental specifications
Ambient pressure Operating: 647 to 1060 hPa
Storage: 500 to 1060 hPa
Temperature Operating: 0 to 40 °C (32 to 104 °F)
Storage: –20 to 60 °C (–4 to 140 °F)
Humidity (non-condensing) Operating: 10 % to 85 %
Storage: 10 % to 85 %
Protection against ingress of IPX ratings:
water – Main unit with battery attached is IPX 4, protected against
splashing water.
– Main unit without battery attached is IPX 7, protected against
temporary immersion.
– Swappable battery alone, unattached, is not IPX rated.
Electrical characteristics
Power source Rechargeable 3.6 V lithium-ion swappable battery, available
from Dräger
Protection class Internally powered
Mode of operation Continuous
Estimated battery operating ECG only: 22 h
time ECG and continuous SpO2: 18 h
Duration of operation varies according to use of display, alarms,
and wireless environment (roaming).
NOTE
The duration of the battery charge for the M300+ may be
reduced by characteristics of the wireless environment such as
signal quality, power levels, power-save mode, etc. The battery
operating life can also gradually diminish over time.

Infinity M300+

User interface
Controls Six function keys: Alarm pause, view screen, staff alert,
record/mark event, up/down scroll
Display
Size/viewing area 5.5 cm (2.17 in) diagonal LCD
Resolution 220 x 176 pixels
Communications
Wireless Network IEEE 802.11 a/b/g/n wireless Ethernet standards (2.4 – 5GHz)
Radio power output 30 mW (2.4 GHz) / 25 mW (5 GHz)
ECG
Available leads 3-wire lead set: I, II, or III
5-wire lead set: I, II, III, aVL, aVR, aVF, V
6-wire lead set: I, II, III, aVL, aVR, aVF, V, V+
6-wire lead set with Infinity TruST: I, II, III, aVL, aVR, aVF, dV1,
V2, dV3, dV4, V5, dV6
Leads analyzed Any one or two user-selected ECG leads (simultaneously)
Heart rate measurement range 15 to 300 bpm
Accuracy ±2 bpm or ±1 %, whichever is greater
Display update period 2 seconds nominal
Heart rate alarm setting range 20 to 300 bpm
Monitoring frequency response 0.5 to 40 Hz: ±3 dB
Sweep speed 25 mm/s ±10 %
Detected arrhythmia asystole, ventricular fibrillation, ventricular tachycardia,
events/rhythms ventricular run, accelerated idioventricular rhythm,
supraventricular tachycardia, ventricular couplet, bigeminy,
tachycardia, bradycardia, sinus pause, ARR artifact
PVC/min
Time to alarm for the two ven- B1 aami4a 3 to 3.5 seconds
tricular tachycardia waveforms B1 aami4a_h 2 to 2.5 seconds
per 60601-2-27 with amplitude B1 aami4a_d 4 to 5 seconds
normal, one half and twice the B1 aami4b 2 to 2.5 seconds
indicated value are: B1 aami4B_h 2.5 to 3 seconds
B1 aami4b_d 2 to 2.5 seconds
Degree of protection against Type CF
electrical shock
Defibrillation protection In accordance with IEC 60601-2-27
Electrosurgery and cautery Not intended for use during ESU procedures

Infinity M300+

Pacer detection Leads I and (II or lll)
Amplitude ±2 to ±700 mV
Width (dp) 0.1 to 2.0 ms
ST segment analysis
Leads analyzed 3-wire lead set: I, II, or III
5-wire lead set: I, II, III, aVL, aVR, aVF, V
6-wire lead set: I, II, III, aVL, aVR, aVF, V, V+
6-wire lead set with Infinity TruST: I, II, III, aVL, aVR, aVF, dV1,
V2, dV3, dV4, V5, dV6
Isoelectric point Default: –28 ms (before J-point)
ST measurement point Default: +80 ms (after J-point)
ST complex Length: 900 ms (250 samples)
Frequency response: 0.05 to 40 Hz
Update interval 15 s
ST measurement and alarm –15.0 to +15.0 mm, –1.5 to +1.5 mV
limit ranges
ST measurement resolution 0.1 mm (0.01 mV)
ST measurement accuracy ± 0.5mm (0.05 mV) or 15 % RTI (with respect to input) whichever
is greater for all leads, excluding STVM and STCVM
Pulse oximetry (optional)
Parameter display Pulse oximetry oxygen saturation percentage (SpO2), pulse rate
Measurement method Absorption-spectrophotometry
Measurement and display SpO2: 1 to 100 %
range Pulse rate: 30 to 250 bpm
Calibration range 70 to 100 %
Display update period 2 seconds nominal
Maximum hold from previous 30 seconds (in the event of artifact or other error)
update

Infinity M300+

Accuracy SpO2: 0 to 69 % not specified
70 to 100 % sensor-specific as follows:
Masimo LNCS Sensors
SpO2 accuracy1, 2, 3, 4:
LNCS DCI, LNCS DCIP, LNCS Adtx,
LNCS Pdtx Not specified
Pulse rate accuracy: ±3 bpm or ±3 %,
whichever is greater
Low perfusion accuracy, SpO2: ±2 %
Low perfusion accuracy, pulse rate: ±3 bpm or ±3 %,
Masimo RD SET Sensors
RD SET Adt, RD SET Pdt, ±2 %
Pulse rate accuracy: ±3 bpm or ±3 %,
Low perfusion accuracy, SpO2: ±2 %
Low perfusion accuracy, pulse rate: ±3 bpm or ±3 %,
Nellcor Sensors
OxiMAX MAX-A, OxiMAX MAX-AL,
OxiMAX MAX-P, DS100A ±3 %
Dräger Sensors
MS16444 disposable foam pedi,
MS16445 disposable foam ad,
MS16449 disposable vinyl ad,
MS16448 disposable vinyl pedi,
MS13235 reusable sensor ±2 %

Infinity M300+

NOTE
1
Since SpO2 measurements are statistically distributed, only about two-thirds of those measurements
can be expected to fall within ±1 Arms of the value measured by a CO-oximeter.
2
These accuracies have been validated using blood samples obtained from healthy adult volunteers
during induced hypoxia studies in the range of 70 to 100% SpO2 against a laboratory CO-oximeter
and ECG monitor.
3
SpO2 accuracies are expressed as ± “X”% between indicated saturation levels. This variation of the
SpO2 measurement equals ±1 Arms of the value measured by a CO-oximeter.
4
The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia
studies in the range of 70 to 100 % SpO2 against a laboratory CO-oximeter and ECG monitor. This
variation equals ±1 Arms of the pulse rate value measured by the ECG monitor.
Nominal wavelength: Nellcor: Red: 660 nm IR: 910 nm
Masimo: Red: 660 nm IR: 905 nm
SpO2 alarm range 20 to 100 %
Pulse rate alarm range 30 to 240 bpm
Power Nellcor: Red: 3 mW (maximum) IR: 4 mW (maximum)
Masimo: Red: 0.9 mW (maximum) IR: 0.9 mW (maximum)
LED drive is current limited by hardware mechanisms

Infinity M300+
Infinity M300+ battery charging station
Infinity M300+ battery charging station specifications

Physical specifications
Size, H x W x D 101.6 x 508 x 114.3 mm (4 x 20 x 4.5 in)
Weight, with 0 batteries 1.46 Kg (3.25 lb)
Weight, with 10 batteries 2.46 Kg (5.4 lb)
Cooling Convection
Electrical specifications
Input Voltage 100 V to 240 V AC
CAUTION:
Use a surge protector with all electrical hookups.
Input frequency (Hz) 50 Hz to 60 Hz AC inputs
Protection Class Class 1
Mode of Operation Continuous
Swappable battery recharging 0 to 100 % within approximately 4 h
time
Environmental requirements
Ambient pressure Operating: 65 to 106 kPa
Storage: 50 to 106 kPa
Temperature Operating: 0 to 35 °C (32 to 95 °F)
Storage: –20 to 60 °C (–4 to +140 °F)
Humidity (non-condensing) Operating: 10 % to 95 %
Storage: 10 % to 95 %
Protection against ingress of IPX1 (dripping) per IEC 60529
water

Infinity M300+
M300/M300+ Performance data
The following disclosures related to algorithm performance using certain waveforms are added or updated
to the monitoring specifications:
M300/M300+ ECG/Arrhythmia/ST Supplemental information

Time to alarm for Ventricular tachycardia 1mVpp, 206 bpm
tachycardia
Gain 0.5, range 3.0 to 3.5 seconds, average 3.3 seconds
Ventricular tachycardia 2 mVpp, 195 bpm
Tall T wave rejection capability 1.20 mV T wave amplitude
Heart rate averaging method Heart rate is normally based on the average R-R interval calculated
over the last 10 seconds.
Response time of heart rate HR change from 80 to 120 bpm:
meter to change in heart rate
Range: [3.9 to 5.38 seconds] Average: 4.5 seconds
HR change from 80 to 40 bpm:
Range: [5.31 to 6.73 s] Average: 5.89 seconds
Heart rate meter accuracy and Ventricular bigeminy: 80 bpm
response to irregular rhythm
Slow alternating ventricular bigeminy: 60 bpm
Rapid alternating ventricular bigeminy: 120 bpm
Bidirectional systoles: 90 bpm
Accuracy of input signal Methods A, B, C, and D from IEC 60601-2-27 were used to establish
overall system error and frequency response.
Lead-off sensing applied current Lead-off sensing applied current < 0.1 µ ampere
M300/M300+ User Interface

Time from alarm condition to System alarm delay: < 1/s
representation

M300/M300+ accessories overview
M300+ System Components
The following parts are related components of the M300+. Contact your Dräger representative for
additional information.
T
M300+ Part Part Number

SHIP UNIT M300+ MS33648
E/M ASY M300+ BATTERY MS33308
SHP OEM INF M300+ BATTERY CHGR MS33198
SHP EXC M300+ MS33659
POUCH M300+ WATERPROOF NEW TAG MS33867
BATTERY RETAINER (PACKAGE OF 10) MS34708
For more information on M300-related accessories, refer to the IFU that ships with this supplement, Infinity
CentralStation Wide SW VG 1.n and Infinity M300.
Pulse Oximetry (SpO2) monitoring with Masimo (for M300/M300+)
The following components are for both M300 and M300+. Contact your Dräger representative for
additional information.
NOTE
– For Masimo sensors, there are unique part numbers for Global, USA, and Japanese location
references.
– Always refer to the Directions for Use accompanying the Masimo patient accessories.
– LNCS intermediate cables are designed to last approximately 17,000 hours while actively monitoring
SpO2 (for example 4 years if monitoring occurs 12 hours a day). This duration is monitored by a chip
inside the cable.
LNCS Adhesive SpO2 Sensors

Global Part USA Part Japanese Part Description
Number Number Number
MP00790 MP03011 MP03089 Masimo SpO2-Sen.LNCS Adtx.Bx20


MP00793 MP03012 MP03090 Masimo SpO2-Sen.LNCS Pdtx.Bx20
LNCS Reusable SpO2 Sensors

Global Part USA Part Japanese Description
Number Number Part Number
MP00796 MP03019 MP03097 Masimo SpO2-Sensor LNCS DC-I
MP00795 MP03020 MP03098 Masimo SpO2-Sensor LNCS DC-IP
MP00788 MP03021 MP03099 SpO2 Masimo Sen LNCS-TC-I Ear
MP00799 MP03022 MP03101 SpO2 Masimo Sen LNCS-TF-I
MP00789 MP03023 MP03102 SpO2 Masimo Sen LNCS-YI Multi
MP02993 MP03024 MP03103 SpO2 Masimo Sen LNCS DBI Adult
NOTE:
Masimo does not make any claims regarding mo-
tion for this sensor.
NOTE
To use Masimo M-LNCS and RD-SET sensors, an additional intermediate cable is required.
M-LNCS Adapter Cables

MP02994 MP03028 MP03107 Adapter Cable M-LNCS to LNC
M-LNCS Adhesive SpO2 Sensors

MP02976 MP03071 MP03173 SpO2 Masimo M-LNCS Adtx-3, 20p
MP02977 MP03072 MP03174 SpO2 Masimo M-LNCS Pdtx-3, 20p

M-LNCS Reusable SpO2 Sensors

MP02981 MP03080 MP03182 SpO2 Masimo M-LNCS DCI Adult
MP02982 MP03081 MP03183 SpO2 Masimo M-LNCS DCIP Pedi
MP02983 MP03082 MP03184 SpO2 Masimo M-LNCS TC-I Ear
MP02985 MP03083 MP03185 SpO2 Masimo M-LNCS TF-I Adult
MP02984 MP03084 MP03186 SpO2 Masimo M-LNCS YI Multis.
MP03207 MP03085 MP03187 SpO2 Masimo M-LNCS DBI Adult
NOTE:
Masimo does not make any claims regarding
motion for this sensor.
Masimo RD-SET SpO2 Sensors

MS33726 MS33745 MS33764 Masimo SpO2 RD-SET Adt
MS33727 MS33746 MS33765 Masimo SpO2 RD-SET Pdt
MS33740 MS33759 MS33778 Masimo SpO2-Sen. RD-SET DC-I
MS33741 MS33760 MS33779 Masimo SpO2-Sen RD-SET DCIP
Masimo RD-SET Adapters

MS33731 MS33750 MS33769 RD to LNOP adapter
MS33732 MS33751 MS33770 RD to LNCS adapter
MS33734 MS33753 MS33772 RD to M-LNCs adapter
RD SET intermediate cables

PN Description
MS34436 SpO2 intermediate cable Masimo RD-SET, 1.2 m
MS34437 SpO2 intermediate cable Masimo RD-SET, 3 m

Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures concerning electromagnetic

compatibility. During installation and before initial operation, follow the information in section: "EMC
declaration for M300+" (page 41).
This device can be affected by other electrical devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may occur if no protective measures against electrostatic
discharge are employed in the following situations:
– When touching the pins of connectors that carry the ESD warning symbol.
– When establishing connections with these connectors.
To prevent malfunctions, observe the following measures and train the relevant personnel:
– Observe the ESD protective measures. Such measures may include wearing antistatic cloth-
ing and shoes, touching a potential equalization pin before and while making the connection,
or using electrically insulating and antistatic gloves.
– Observe the requirements for the electromagnetic environment. Observe the following sec-
tion: "Electromagnetic environment" (page 41).
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g.,
defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are
operated too close to this device or its cables, the functional integrity of this device may be
compromised by electromagnetic disturbances. As a result, the patient could be put at risk.
Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication
devices, to ensure that the essential performance of this device is fulfilled.
Maintain an adequate distance between this device and other medical electrical equipment.

EMC declaration for M300+
General information
This device was tested for electromagnetic compatibility using accessories from the list of accessories.
Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use
of non-compliant accessories may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the device.
This device may be used in the direct vicinity of other devices only if Dräger has approved this device
arrangement. If no approval has been given by Dräger, it must be ensured that this device functions
correctly in the desired arrangement before use. The instructions for use for the other devices must be
followed.
Electromagnetic environment
This device may only be used in environments specified in section "M300/M300+ Device description"
on page 7.
Emissions Compliance
Radiated emissions Class A, group 1 (30 MHz to 1 GHz)
Conducted emissions Class A, group 1 (150 kHz to 30 MHz)
NOTE
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required), this equipment might not offer adequate protection to radio-frequency communication ser-
vices. The user might need to take mitigation measures, such as relocating or re-orienting the equip-
ment.
Immunity against Test level and required electromagnetic environ-

ment
Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kV
Air discharge: ±15 kV
Magnetic fields at mains frequency 30 A/m
(IEC 61000-4-8)
Radiated high-frequency disturbances 80 MHz to 2.7 GHz: 3 V/m
(IEC 61000-4-3)
Conducted high-frequency disturbances 150 kHz to 80 MHz: 3 VRMS, ISM bands: 6 VRMS
(IEC 61000-4-6)
Electromagnetic fields in the vicinity of wireless Various frequencies from 385 MHz to 5785 MHz:
communication devices 9 V/m to 28 V/m, with various pulse modulations and
immunity test levels.

Additional information
Recommended separation distances from wireless communication devices
To ensure that the functional integrity of this device is maintained, there must be a separation distance of
at least 1.0 m (3.3 ft) between this device and wireless communication devices.
ECG, arrhythmia, and ST segment monitoring with M300/M300+
The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST
segment changes need to be determined by a clinician.
NOTE
ST analysis is always performed using a dedicated filter which ensures diagnostic quality. ST segment
of the ECG waveform may appear differently from the ST segment of the ST complex. An ECG report is
not of diagnostic quality. Therefore, the ST segment of the ECG waveform on the report may appear
differently from the ST segment of the ST complex. The only report of ECG diagnostic quality is a Rest
ECG report.
NOTE
When monitoring in dual-lead mode, ECG signal processing uses pre-determined logic to assess signal
quality and determine which lead to use for analysis. If the first lead's signal quality is poor but the second
lead's signal quality is good, the algorithm puts more weight on the good lead for monitoring the patient's
condition
Monitoring paced patients

The amplitude to identify a pulse as a pacer pulse is now:
Amplitude: ±2 to ±700 mV
Operating concept
To transfer data from an M300/M300+ to another M300/M300+:
The following caution is added:
CAUTION
Do not select the same M300/M300+ as the source and the destination for data transfer. This action
results in discharging patient data on the M300/M300+.

M300 offline recordings

While the M300 is offline or the R50N recorder is not available, the last five recordings (automatic or
manual) are stored on the M300. When the connection is restored, those recordings are sent to the R50N
recorder.
Known issues
Continuous pacer spikes on M300
CAUTION
Continuous pacer spikes can appear on the ECG waveform if the M300 is docked on the bedside
charger and the electrode impedances are not balanced. Continuous pacer spikes can also appear as
a result of electromagnetic interference generated by other devices in the patient’s immediate vicinity.
False pacer spikes may affect the accuracy of ECG beat classification.
To resolve this issue:
– Be sure to use new electrodes.
– Temporarily remove the Infinity M300 from the bedside charger until the electrode impedance
normalizes.
– Turn pacer detection off, if appropriate.
Reviewing stored ST complexes at Symphony

When reviewing the M300/M300+ stored ST complexes at Symphony, the three augmented leads (aVR,
aVL, aVF) are displayed in the ST complexes view only when the M300/M300+ has 12-leads available
(i.e., M300/M300+ 6-wire with TruST enabled).
ECG lead wires setting

NOTE
In TruST 12-lead mode (ECG Lead Wires = 6 wires and TruST 12-Lead = On), leads III, aVL, and aVF
are not displayed on a remote view from a network device.
To resolve this issue, TruST 12-lead mode must be disabled, as follows:
Set TruST 12-Lead = Off,
or set ECG Lead Wires = 5.
ICS VG1 incorrectly displays % Paced and the alarm off symbol (IEC alarm off) in the heart rate
parameter field.
The alarm off symbol should not display because there are no alarms associated with % Paced.

Reprocessing of device-specific components
This section provides information for the reprocessing of M300 and M300+ device-specific components
and accessories. Keep this supplement with the instructions for use.
Safety Information
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of infection.
– Observe the infection prevention policies and reprocessing regulations of the healthcare
facility.
– Observe national infection prevention policies and reprocessing regulations.
– Use validated procedures for reprocessing.
– Reprocess reusable products after every use.
– Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing
devices.
CAUTION
Risk due to faulty products
– Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed
products.
– Check the products for signs of wear and replace them if necessary.
Classification of medical devices for reprocessing
Medical devices and their components are classified according to the way they are used and the resulting
risk.
Classification Explanation
Non-critical Components that come only into contact with skin that is intact
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous
membranes or pathologically altered skin
Critical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with
blood

Reprocessing list
The M300 and M300+ and all components and accessories are classified as non-critical.
Components Surface Manual Machine Steam Special

disinfection cleaning cleaning with sterilization reprocessing
with cleaning followed by thermal measures
disinfection by disinfection
immersion
M300 and M300+ Yes N/A N/A N/A N/A
Detachable battery Yes N/A N/A N/A N/A
Battery retainer Yes N/A N/A N/A N/A
Manual disinfectant and simultaneous cleaning
The indicated surface disinfectants and recommendations regarding classes of active ingredients are as
follows:
Class of active ingredient Surface disinfectant Manufacturer

Chlorine-releasing agents Actichlor plus Ecolab
BruTab 6S Brulin
Clorox Professional Disinfecting Clorox
Bleach Cleaner
Dispatch Hospital Cleaner Disin-
fectant Towels with Bleach
Klorsept 17 Medentech
Oxygen-releasing agents Descogen Liquid Antiseptica
Descogen Liquid r.f.u.
Dismozon plus Bode Chemie
Dismozon pur
Oxycide Ecolab USA
Perform Schülke & Mayr
Virkon DuPont

Class of active ingredient Surface disinfectant Manufacturer

Quaternary ammonium com- Mikrozid sensitive liquid1)
Schülke & Mayr
pounds Mikrozid sensitive wipes 1)
Mikrozid alcohol free liquid1)

Mikrozid alcohol free wipes1)
acryl-des1)
Aldehydes Buraton 10 F Schülke & Mayr
1) Virucidal against enveloped viruses
Dräger recommends using a surface disinfectant from the list above. Other disinfectants are used at one’s
own risk.
Dräger points out that oxygen-releasing agents and chlorine-releasing agents may cause color change in
some materials. Color change does not indicate that the product is not functioning correctly.
At the time of validation, the listed surface disinfectants showed good material compatibility. The manu-
facturers of the surface disinfectants have verified at least the following spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Observe the specifications of the surface disinfectant manufacturers. Use surface disinfectants that are
nationally authorized.
Cleaning and surface disinfection for the M300+
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
Ensure that no liquid penetrates the device.
1 Visually inspect the device for soiling. Remove soiling immediately.

2 To thoroughly clean the device, use a cloth dampened with low level disinfectant for surface
disinfection.
3 After the product has been exposed to the disinfectant for the specified contact time, remove residual
disinfectant.
4 Wipe with a cloth dampened with water (preferably drinking-water quality). Allow the product to dry.
5 Check the product for visible soiling. Repeat steps 1 to 4 if necessary.

6 Check the product for visible damage and replace if necessary.
Cleaning and surface disinfection for the battery retainer
1 Remove the battery retainer from the M300+.

2 To thoroughly clean the battery retainer, use a cloth dampened with low level disinfectant for surface
disinfection. If needed clean with a toothbrush and water to remove any debris.
3 After the retainer has been exposed to the disinfectant for the specified contact time, remove residual
disinfectant.
4 Wipe with a cloth dampened with water (preferably drinking-water quality). Allow the product to dry.
5 Check the retainer for visible soiling. Repeat steps 2 to 5 if necessary.


This supplement only applies to
Infinity® M300 and M300+ Series VG2.4
with the Serial No.:
If no Serial No. has been filled in by Dräger,
these Instructions for Use are provided for
general information only and are not intended for
use with any specific machine or unit.
This document is provided for customer
information only, and will not be updated or
exchanged without customer request.
Directive 93/42/EEC The radio equipment in the Infinity M300 patient

concerning Medical Devices monitor complies with the Radio Equipment
Directive (2014/53/EU). A copy of the
Declaration of Conformity is available at the
following Internet address:
www.draeger.com/doc-radio
Manufacturer:
Draeger Medical Systems, Inc.

3135 Quarry Road
Telford, PA 18969-1042
U.S.A.
(215) 721-5400
(800) 4DRAGER
(800 437-2437)
FAX (215) 723-5935
http://www.draeger.com
In Europe, Middle East, Africa, Latin

America, Asia Pacific distributed by
Drägerwerk AG & Co. KGaA
Moislinger Allee 53 – 55
23542 Lübeck
Germany
+49 451 8 82-0
FAX +49 451 8 82-20 80
http://www.draeger.com
MS33235– RI 03 en
© Drägerwerk AG & Co. KGaA
Edition: 4 – 2019-01
(Edition: 1 – 2016-12)
Dräger reserves the right to make modifications
to the equipment without prior notice.

Infinity M300 and M300+ Series: Supplement

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Infinity M300 and M300+ Series: Supplement

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Supplement

Infinity® M300 and M300+ Series

WARNING Infinity® M300 and M300+ Series

Trademark Trademark owner

Supplement – Infinity® M300 and M300+ Series – VG2.4 3

4 Supplement – Infinity® M300 and M300+ Series – VG2.4

Supplement Infinity® M300 and M300+ Series VG2.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Infinity® M300/M300+ Indications for use/Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Infinity M300/M300+ Features for VG2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

M300/M300+ accessories overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Reprocessing of device-specific components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Supplement – Infinity® M300 and M300+ Series – VG2.4 5

6 Supplement – Infinity® M300 and M300+ Series – VG2.4

Supplement Infinity® M300 and M300+ Series VG2.4

M300/M300+ Device description

Supplement – Infinity® M300 and M300+ Series – VG2.4 7

Infinity® M300/M300+ Indications for use/Intended use

General safety information

8 Supplement – Infinity® M300 and M300+ Series – VG2.4

Supplement – Infinity® M300 and M300+ Series – VG2.4 9

10 Supplement – Infinity® M300 and M300+ Series – VG2.4

Not made with natural rubber latex

Not made with natural

Supplement – Infinity® M300 and M300+ Series – VG2.4 11

Infinity M300/M300+ Features for VG2.4

12 Supplement – Infinity® M300 and M300+ Series – VG2.4

QRS detection amplitude

QRS detection amplitude: 0.5 to 5.0 mVp-v RTI

ECG QRS processing settings

Gain/Scale column mV/cm Detection threshold

Supplement – Infinity® M300 and M300+ Series – VG2.4 13

M300/M300+ Arrhythmia processing

14 Supplement – Infinity® M300 and M300+ Series – VG2.4

ECG signal processing and display

Patient preparation for ECG monitoring

Supplement – Infinity® M300 and M300+ Series – VG2.4 15

16 Supplement – Infinity® M300 and M300+ Series – VG2.4

ICS Telemetry defaults screen

A Reduced Main screen showing vital signs in real time

Supplement – Infinity® M300 and M300+ Series – VG2.4 17

M300 Demographic screens

Use Up and Down arrows to go

18 Supplement – Infinity® M300 and M300+ Series – VG2.4

Low battery alarm

Critical battery alarm

Supplement – Infinity® M300 and M300+ Series – VG2.4 19

M300+ front of the device

The following figure shows the M300+ front of the device.

Speaker for acoustic alarm signal

Battery charge symbol

Battery retainer (see Note below)

Swappable battery pack

Battery release tabs

20 Supplement – Infinity® M300 and M300+ Series – VG2.4

M300+ swappable battery

Battery safety information