Dräger Infinity M300 series Owner's manual

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

Supplement – Infinity® M300 – VG2.4 3
Contents
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Information about this document . . . . . . . . . 5
Typographical conventions . . . . . . . . . . . . . . . . 5
Infinity M300 VG2.4. . . . . . . . . . . . . . . . . . . . . 7
Infinity M300 Device description. . . . . . . . . . . . 7
Indications for use/Intended use . . . . . . . . . 9
Contraindication . . . . . . . . . . . . . . . . . . . . . . . .9
For your safety and that of your patients. . . 10
Mandatory reporting of adverse events . . . . . . 10
General safety information . . . . . . . . . . . . . . . . 10
Environment of Use . . . . . . . . . . . . . . . . . . . . . 11
Patient Population . . . . . . . . . . . . . . . . . . . . . . 12
Open-source software . . . . . . . . . . . . . . . . . . . 12
Network security information and
recommendations. . . . . . . . . . . . . . . . . . . . . . . 12
Device symbols . . . . . . . . . . . . . . . . . . . . . . . . 16
Infinity M300 Features for VG2.4. . . . . . . . . . 17
QRS Threshold. . . . . . . . . . . . . . . . . . . . . . . . . 17
M300 Arrhythmia processing . . . . . . . . . . . . . . 19
ECG signal processing and display . . . . . . . . . 20
Patient preparation for ECG monitoring . . . . . . 20
ECG precautions . . . . . . . . . . . . . . . . . . . . . . . 21
ICS Telemetry defaults screen . . . . . . . . . . . . . 22
M300 Demographic screens. . . . . . . . . . . . . . . 23
Alarm settings. . . . . . . . . . . . . . . . . . . . . . . . . . 24
Technical specifications . . . . . . . . . . . . . . . . . . 25
M300 Performance data . . . . . . . . . . . . . . . . . . 29
M300 accessories overview. . . . . . . . . . . . . . 30
Pulse Oximetry (SpO2) monitoring with
Masimo (for M300) . . . . . . . . . . . . . . . . . . . . . . 30
Electromagnetic compatibility (EMC) . . . . . . 33
EMC third edition . . . . . . . . . . . . . . . . . . . . . . . 33
EMC fourth edition . . . . . . . . . . . . . . . . . . . . . . 38
Additional information . . . . . . . . . . . . . . . . . 41
ECG, arrhythmia, and ST segment monitoring
with M300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Known issues . . . . . . . . . . . . . . . . . . . . . . . . . 44
Reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . 45
Safety Information . . . . . . . . . . . . . . . . . . . . . . 45
Information on reprocessing . . . . . . . . . . . . . . 45
Classification for reprocessing . . . . . . . . . . . . 46
Before reprocessing . . . . . . . . . . . . . . . . . . . . 47
Validated reprocessing procedures . . . . . . . . . 48
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Surface disinfection . . . . . . . . . . . . . . . . . . . . . 50
Other agents and reprocessing procedures . . 51
Reprocessing of patient-specific accessories . 52
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Surface disinfection . . . . . . . . . . . . . . . . . . . . . 54
Other agents and reprocessing procedures . . 55
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 56

4 Supplement – Infinity® M300 – VG2.4
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Supplement – Infinity® M300 – VG2.4 5
Information about this document
Information about this document
Typographical conventions
Trademarks
Trademarks owned by Dräger
The following web page provides a list of the countries in which the trademarks are registered:
https://www.draeger.com/trademarks
1 Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each
new sequence of actions.
 Bullet points indicate individual actions or different options for action.
– Dashes indicate the listing of data, options, or objects.
(A) Letters in parentheses refer to elements in the related illustration.
A Letters in illustrations denote elements referred to in the text.
Trademark
Infinity®
MCable®
MonoLead®

Information about this document
6 Supplement – Infinity® M300 – VG2.4
Trademarks owned by third-party manufacturers
Definitions
Trademark Trademark owner
rainbow®Masimo Corporation.
Masimo®
Masimo® SET® (Signal
Extraction Technology)
Capnoline®Medtronic
Microstream®
TOFscan®IDMED
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate injury to the user or patient or in damage to
the equipment or other property.
NOTE
A NOTE provides additional information intended
to avoid inconveniences during operation.

Supplement – Infinity® M300 – VG2.4 7
Infinity M300 VG2.4
Infinity M300 VG2.4
This supplement contains the VG2.4 instructions for use for the Infinity M300.
The IFU that ships with this supplement is the Infinity CentralStation Wide SW VG 1.n and Infinity M300.
Infinity M300 Device description
The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which
monitors ECG and SpO2 physiological data, features a color display, and local alarm alerts and keypad
interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis. SpO2
functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG
monitoring with a reduced set of electrodes by deriving values for missing leads.
Infinity M300 components
The standard Infinity M300 includes the following:
Infinity M300 patient-worn device
Infinity M300 Bedside Charger
Infinity M300 CentralCharger
Infinity M300 programming kit
Infinity M300 communications
Infinity M300 connects to the Infinity network via 802.11 wireless communication with hospital access
points (AP). From the AP, data is routed over the Infinity network via wired Ethernet for real-time display
and annunciation at the Infinity CentralStation Wide (Widescreen) central monitoring workstation. The
Infinity CentralStation (ICS) Wide allows for simultaneous central monitoring of up to thirty-two (32) Infinity
M300 devices to support wireless telemetry monitoring.
Infinity M300 user interfaces and functions
The Infinity M300 communicates bilaterally with the Infinity CentralStation (ICS) which serves as the
primary display, user interface and alarm annunciator for acquired M300 physiological patient data. The
Infinity M300 6-button local keypad and display serves as a secondary user interface for clinicians to
access local features and functions.

Infinity M300 VG2.4
8 Supplement – Infinity® M300 – VG2.4
To facilitate patient mobility the M300 can be placed in a disposable or re-usable shower pouch and worn
by the patient. When a patient is sedentary (in bed or sitting) the clinician can place the Infinity M300 in
the Bedside Charger to provide a slow charge for the device. When the Infinity M300 is not in clinical use,
it may be stored and recharged at an accelerated rate in the CentralCharger.
At the ICS clinicians perform the following functions:
Admit / Discharge patients
Initiate / Discontinue M300 Standby
Enter patient demographics
Assign patient categories
Assign alarm limits
Manage M300 audio pause, alarm pause, alarm silence
Access patient alarm history
Access patient full disclosure records
At the Infinity M300 clinicians perform the following functions:
Turn device on and off
Adjust alarm volume
Manage alarm pause
Scroll through waveforms
Discharge patients
Initiate strip recordings
Issue staff alerts

Supplement – Infinity® M300 – VG2.4 9
Indications for use/Intended use
Indications for use/Intended use
The Infinity 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 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 is not compatible for use in an MRI magnetic field.

For your safety and that of your patients
10 Supplement – Infinity® M300 – VG2.4
For your safety and that of your patients
Mandatory reporting of adverse events
Serious adverse events with this product must be reported to Dräger and the responsible authorities.
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical device.
Warnings:
WARNING
To properly use the 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.

Supplement – Infinity® M300 – VG2.4 11
For your safety and that of your patients
Cautions:
Environment of Use
The Infinity M300 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 determine
when use of the device is indicated, based upon their professional assessment of the patient's medical
condition.
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.

For your safety and that of your patients
12 Supplement – Infinity® M300 – VG2.4
Patient Population
The Infinity 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.
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:
https://www.draeger.com/en_me/Hospital/Online-Services/Open-Source
Network security information and recommendations
Dräger provides the following security information and recommendations:
Dräger recommends always following network security best practices, such as maintaining software,
segmenting via firewalls, closing unused ports, restricting user permissions, limiting third party access,
and monitoring network activity.
M300 device settings may be compromised in the event of a cybersecurity attack or other configuration
error. To restore device settings to their previous state, power cycle the unit and select NO when
prompted on the New Patient screen. Device settings can be restored manually with patient discharge
and re-admit at the M300. In the event of a cybersecurity attack, if the device enters a fail state
(sustained alarm tone sound), power cycle the unit. If a device experiences multiple resets and/or fail
state behavior, assign each patient to a bedside monitor, isolate the affected devices and immediately
contact your hospital’s biomedical department and IT department for support. Do not place devices
back into service until the situation is resolved.
Dräger recommends the use of WPA2-Enterprise/EAP-TLS to provide for strong authentication and
data protection for wireless communication between M300 and 802.11 access points. With this
protection in place, clinical data will be secure in a wireless encrypted tunnel. Customers configuring
wireless infrastructures with WPA or WPA+WPA2 will cause the M300 to use the deprecated TKIP
cipher which may compromise security. Dräger recommends configuring the network infrastructure to
use WPA2 only.
NOTE
Clinical judgment must be used to determine when the 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.

Supplement – Infinity® M300 – VG2.4 13
For your safety and that of your patients
Dräger recommends that the responsible organization install and operate Infinity monitoring devices
on separate, isolated, VLANs to reduce risk from network security vulnerabilities. Use of QoS with
M300 is required to ensure optimal network data transmission. Without these measures there is an
increased risk that critical events may go undetected in cases of malicious attack, which could result
in patient harm.
Dräger maintains a product security page for continued visibility into cybersecurity threats in the field
and possible vulnerabilities in our devices. In the event you encounter a cybersecurity threat or identify
a security vulnerability in one of our products, visit the following website to find instructions on how to
provide this information to Dräger via encrypted e-mail: https://static.draeger.com/security/.
The M300 device provides logging of software resets and presence of multicast. M300 error logs may
be obtained using the device webpage or via connection to a serial programming cable and
appropriate terminal software. If errors are observed, report the condition to the hospital's Biomed and
IT departments.
To maintain the M300 logs for investigatory purposes, isolate the affected M300 unit(s), place the
devices in a bedside charger, and contact Dräger service personnel for support and troubleshooting.
Do not place the M300 in the CentralCharger as this will discharge the patient deleting useful data.
The device configurations can be recovered by one of the following methods:
– Programming cable with password
– Manually discharge patient, re-admit and configure settings
– Manually configure settings at the M300
The M300 device contains the following interfaces:
The M300 device communicates via the 802.11 wireless LAN standard. Client ports are used outbound
from the device, while server ports accept incoming connections inbound from other devices on the
network:
Type Purpose
Display Visualize various clinical parameters and device configuration settings
Keypad Provide for modest level of user interaction, such as startup/shutdown of
device; alarm silence; and local discharge
Wireless Network Provides for communication with other Infinity network devices and some
diagnostic tools via 802.11
Serial Console Provides access to service menu to allow for configuration and
maintenance of device
Application Protocol Transport Protocol Port Number Client/Server
FTP TCP 21 Server
HTTP TCP 80 Server
Infinity ACS TCP 1950 Server
Infinity PDS TCP 2050 Client
Infinity NameService TCP 2150 Client

For your safety and that of your patients
14 Supplement – Infinity® M300 – VG2.4
In the presence of multicast network traffic, ‘Network Config Error’ will be annunciated on the M300
display and will be captured in the error log. M300 error logs may be obtained using the device
webpage or via connection to a serial programming cable and appropriate terminal software. If this
error is observed, report the condition to the hospital's Biomed and IT departments. If a device
experiences multiple resets the unit may enter a fail state and issue a sustained audible alarm. If your
facility experiences multiple M300 device resets and/or fail state behavior, assign each patient to a
bedside monitor, isolate the affected devices and immediately contact your hospital’s biomedical
department and IT department for support. Do not place devices back into service until the situation is
resolved.
To enhance network and device security, restrict physical access to the Infinity network, monitoring
devices and accessories to hospital personnel according to job function and classification. Restrict
physical access to unused ethernet ports, and unused USB and serial ports.
Modifications to the Infinity network after initial installation could result in degraded performance and/or
security risks. Contact Dräger Service personnel to ensure optimal network performance for any
planned network modification. Unauthorized modifications to network settings could degrade network
performance and could result in patient harm due to delayed assessment or intervention.
Infinity Recorder TCP 6000 Client
Infinity Recorder TCP 6050 Client
Infinity RemoteRecord TCP 7100 Server
Infinity LocalDischarge TCP 9200 Client
Infinity LLIP TCP 18000 Client
NOTE
M300 is an embedded code device that verifies sensitive data integrity (i.e., code space, stored
configuration data, and DRAM content) at startup and during operation. If the stored settings are corrupt,
the device assumes that DRAM has failed and restores its factory default settings with audible and visual
notification to users.
Application Protocol Transport Protocol Port Number Client/Server

Supplement – Infinity® M300 – VG2.4 15
For your safety and that of your patients
Infinity Network Diagram Example Configuration
M300 message
The following message may display on the M300:
Priority Message Description Action
None Network config error Multicast traffic is detected
on the VLAN.
Contact your hospital
biomedical department and IT
department for support.
   

 

 









 
 






 

 

For your safety and that of your patients
16 Supplement – Infinity® M300 – VG2.4
Device symbols
The following table lists the new hardware device symbols displayed on various Dräger hardware.
Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, that ships with this supplement
for additional device symbols.
Symbol Description
Do not re-use
Do not re-use, single patient use
Not made with natural rubber latex
Not made with natural rubber latex
Medical Device
Caution: Federal law restricts this device to sale by or on the order
of a physician.
Not made with natura
l
rubber latex
For USA:
Rx only

Supplement – Infinity® M300 – VG2.4 17
Infinity M300 Features for VG2.4
Infinity M300 Features for VG2.4
This section contains the Infinity M300 features for the VG2.4 release.
QRS Threshold
Depending on the software versions running on the ICS and the M300 devices, the procedure you follow
to set the QRS threshold on the M300 will differ:
If ICS is VG2.1.1 or later, and the M300 is VG 2.4 or later, you set the QRS threshold by a menu se-
lection, 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.
To set the QRS Threshold using ICS VG2.1.1 and M300 VG2.4
From the Main ICS screen:
1Click System setup on the ICS.
2Click Layouts.
3Click one of the following:
–Normal to detect QRS complexes of normal amplitude.
–Low to detect QRS complexes of low amplitude.
NOTE
Patient admitted on 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
between 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.

Infinity M300 Features for VG2.4
18 Supplement – Infinity® M300 – VG2.4
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:
1Click System setup on the ICS.
2Click Layouts.
3Click the dropdown arrow of the appropriate Gain/Scale channel.
4Select 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.
ECG QRS processing settings
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.
Gain/Scale column mV/cm Detection threshold
For all ECG waveforms: 0.25, 0.5, 1
(default), 2, 4, 8 mV/cm
The M300 uses an AAMI-compliant regular
QRS threshold when you select a scale of 1,
2, 4, or 8 mV/cm. If you select a scale of 0.25
or 0.5 mV/cm, the M300 lowers the detection
threshold, and the AAMI requirement is not
met.
8 >
0.35 mV
4>
0.35 mV
2>
0.35 mV
1>
0.35 mV
0.5 >0.17 mV
0.25 >0.17 mV

Supplement – Infinity® M300 – VG2.4 19
Infinity M300 Features for VG2.4
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:
1ASY (asystole)
2VF (ventricular fibrillation)
3VTACH (ventricular tachycardia)
4RUN (ventricular run)
5AIVR (accelerated idioventricular rhythm)
6SVT (supraventricular tachycardia)
7CPT (ventricular couplet)
8BGM (bigeminy)
9TACH (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.

Infinity M300 Features for VG2.4
20 Supplement – Infinity® M300 – VG2.4
ECG signal processing and display
The 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 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 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.
Patient preparation for ECG monitoring
The following tips provide optimal ECG monitoring results but must never replace hospital-approved
practices or the recommendations of the electrode manufacturer.
Follow hospital procedures for proper skin preparation. Dräger recommends Ag/AgCl disposable
electrodes. 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
detection threshold is configured to Normal, may be interpreted as QRS complexes. The algorithm has
implemented 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
highest 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.
NOTE
For heart rates of 300 bpm and greater, the monitor may display VF and not the expected +++ as the
parameter value.