Dräger Infinity M300 series Manuel du propriétaire
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.
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