Dräger Infinity M300 series Supplemental Manual
Supplement
Infinity M300 and M300+ Series
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.
Infinity M300 and M300+ Series
Software VG2.4
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2 Supplement – Infinity M300 and M300+ Series – VG2.4
Contents
Supplement Infinity M300 and M300+ Series VG2.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Infinity M300/M300+ Indications for use/Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Open-source software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Device symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Infinity M300/M300+ Features for VG2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
QRS Threshold. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
M300/M300+ Arrhythmia processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
ECG signal processing and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Patient preparation for ECG monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
ECG precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ICS Telemetry defaults screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
M300 Demographic screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Alarm settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Infinity M300+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
M300+ front of the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
M300+ swappable battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
M300+ battery charging station for swappable batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Discharging a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
M300/M300+ Performance data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
M300/M300+ accessories overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
M300+ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Pulse Oximetry (SpO2) monitoring with Masimo (for M300/M300+) . . . . . . . . . . . . . . . . . . . . . . . . 35
Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
EMC declaration for M300+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Additional information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Known issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Reprocessing of device-specific components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Classification of medical devices for reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Manual disinfectant and simultaneous cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Supplement – Infinity M300 and M300+ Series – VG2.4 3
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4 Supplement – Infinity M300 and M300+ Series – VG2.4
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 powered 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 CentralCharger
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 CentralCharger.
Infinity M300+
The standard Infinity M300+ includes the following:
Infinity M300+ patient-worn transceiver
Infinity M300+ swappable battery (2)
Infinity M300+ remote battery charging station (charging capacity of up to 10 swappable batteries)
Infinity M300+ programming kit
Supplement – Infinity M300 and M300+ Series – VG2.4 5
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.
Infinity M300/M300+ Indications for use/Intended use
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 19 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.
6 Supplement – Infinity M300 and M300+ Series – VG2.4
Infinity M300/M300+ Indications for use/Intended use
WARNING
Inaccurate SpO2 meansurements 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.
Supplement – Infinity M300 and M300+ Series – VG2.4 7
Infinity M300/M300+ Indications for use/Intended use
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 judgement 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
8 Supplement – Infinity M300 and M300+ Series – VG2.4
Infinity M300/M300+ Indications for use/Intended use
Not made with natura
l
rubber latex
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
Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, that ships with this supplement
for additional device symbols.
Supplement – Infinity M300 and M300+ Series – VG2.4 9
Infinity M300/M300+ Features for VG2.4
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 18.
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.
10 Supplement – Infinity M300 and M300+ Series – VG2.4
Infinity M300/M300+ Features for 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:
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 dectection 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 mVpvRTI.
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 (default), 2, 4, 8 mV/cm
The M300/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/M300+ lowers the detection threshold, and the AAMI requirement is not met.
Supplement – Infinity M300 and M300+ Series – VG2.4 11
8 >
4>
2>
1>
0.5 >
0.25 >
0.35 mV
0.35 mV
0.35 mV
0.35 mV
0.17 mV
0.17 mV
Infinity M300/M300+ Features for VG2.4
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.
12 Supplement – Infinity M300 and M300+ Series – VG2.4
Infinity M300/M300+ Features for VG2.4
ECG signal processing and display
The M300/M300+ calculates heart rates within a range of 15 beats to 300 beats per minute, using the RR 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 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 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.
Supplement – Infinity M300 and M300+ Series – VG2.4 13
Infinity M300/M300+ Features for VG2.4
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.
14 Supplement – Infinity M300 and M300+ Series – VG2.4
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