getemed CardioMem CM 100 XT User manual

User Manual
CardioMem® CM 100 XT
ECG-Recorder
Revision 01
Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring

78812021-EN CardioMem®CM 100 XT 3
Contents
1 Information about this Manual .............................................6
2 Intended Operator ................................................................6
3 Intended Use .........................................................................7
4 Indications .............................................................................8
5 Definitions .............................................................................8
6 Regulatory Information .........................................................9
6.1 Medical Device Compliance ..........................................9
6.2 Radio Frequency Compliance........................................9
6.3 Medical Device Classification ........................................9
7 Labeling ...............................................................................10
7.1 Symbols .......................................................................10
7.2 Type Label....................................................................13
7.3 Packaging Label ...........................................................13
8 Safety Information...............................................................14
8.1 General Warnings........................................................14
8.2 General Cautions .........................................................15
9 Warranty and Service Information......................................18
10 Cleaning and Desinfection...............................................18
11 Operating Elements.........................................................19
11.1 Event Button................................................................19
11.2 LED...............................................................................20
11.3 Signaltöne....................................................................20
12 Preparing the Recording..................................................21
12.1 Inserting a Battery .......................................................21

4 CardioMem®CM 100 XT 78812021-EN
12.2 Instructing the Patient.................................................22
12.3 Preparing the Patient’s Skin ........................................23
12.4 Connecting the Electrodes...........................................23
12.5 Placing the Device........................................................24
12.6 Switching on the Device ..............................................25
12.7 Check the Lead Quality................................................25
13 Starting the Recording.....................................................25
14 Recording an Event..........................................................27
14.1 Recording Modes.........................................................27
14.2 Manual Recording........................................................27
14.3 Automatic Recording...................................................27
15 End of Recording .............................................................28
15.1 Removing the Electrodes.............................................28
16 Use of the CM 100 Configurator Software ......................29
16.1 Required Hardware and Software...............................29
16.2 Installation...................................................................30
16.3 Check the System Time................................................32
16.4 Connect the USB Download Cable...............................32
16.5 Switch on the Device ...................................................33
16.6 Start the CM 100 Configurator Software.....................34
16.7 Downloading Recordings.............................................34
16.8 Setup............................................................................40
16.9 Disconnect the Device .................................................43
17 Description of automatic Rhythm Detection...................44
17.1 Heart Rate Detection...................................................44
17.2 Detection of Bradycardia and Tachycardia..................44

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17.3 Detection of Atrial Fibrillation (AFib) ..........................45
17.4 Pause Detection ..........................................................45
18 Disposing of the Device, Batteries and Accessories........46
19 Troubleshooting ..............................................................47
20 Notifications (LED and Speaker) ......................................48
21 Accessories, Ordering Information..................................49
22 Specifications...................................................................50
22.1 General ........................................................................50
22.2 Operating Conditions ..................................................51
22.3 Transport and Storage Conditions...............................51
22.4 Wireless Capabilities ...................................................51
22.5 Electromagnetic Compatibility ....................................52
23 List of Figures...................................................................57

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1 Information about this Manual
This manual is owned by
GETEMED Medizin- und Informationstechnik AG
Oderstr. 77, 14513 Teltow, Germany.
Microsoft and Windows are either registered trademarks or
trademarks of Microsoft Corporation in the United States and/or
other countries. Adobe, Acrobat, and Reader are either registered
trademarks or trademarks of Adobe Systems Incorporated in the
United States and/or other countries. iOS is a trademark or
registered trademark of Cisco in the U.S. and other countries and
is used under license. iPad and iTunes are trademarks or
registered trademarks of Apple Inc. in the United States and/or
other countries. Other company and product names mentioned
herein are trademarks of their respective companies.
Revision History
Revision
Publication Date
Description
01
2017-11-10
1st Publication
2 Intended Operator
The device is intended to be used by trained operators under the
direct supervision of a medical professional in a medical facility or
by the patient after instruction by a medical professional in the
patient's home.
The patient is an intended operator.

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3 Intended Use
The CardioMem CM 100 XT is intended to continuously analyse
and periodically record ECG data for later evaluation by a medical
professional in order:
to document arrhythmias in individuals whose symptoms
occur infrequently
to document the impact of initiating drug therapy for an
arrhythmia
to document the recurrence of an arrhythmia after
discontinuation of drug therapy
to document the results after an ablation procedure for
arrhythmia
to evaluate syncope in individuals whose symptoms occur
infrequently.
The ECG recording is triggered manually by the patient or
automatically by a programmable timer or by an algorithm that
can detect the following arrhythmias:
Tachycardia
Bradycardia
Atrial Fibrillation
Pause
The device is intended to be used in both home environments
and clinical environments. Home environments include
urban/suburban/rural, school/office/retail environments, and
vehicles like trains, airplanes and cars. The device is not intended
to be used near active HF surgical equipment and in RF shielded
rooms of systems for magnetic resonance imaging (MRI). The
device is battery driven and utilizes non-volatile memory to store
ECG data. The device is not intended to be used as a critical
care monitoring system and should not be used in emergency
situations.

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4 Indications
The CardioMem CM 100 XT is indicated for those adult and
pediatric (weight > 10kg) patients who require monitoring for the
detection of the following non-lethal cardiac arrhythmias:
tachycardia, bradycardia, atrial fibrillation, and pause.
Contraindications:
Patients with known allergies or hypersensitivities to
adhesives or hydrogel.
Patients with potentially life-threatening arrhythmias, or
who require inpatient / hospital monitoring.
5 Definitions
The terms “warning” and “caution” are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness. Familiarize yourself with their definitions and
significance. Hazard is defined as a source of potential injury to a
person.
WARNING indicates a potential hazard or unsafe practice which,
if not avoided, could result in death or serious injury.
CAUTION indicates a potential hazard or unsafe practice which, if
not avoided, could result in minor personal injury or damage to
the product or property.
NOTE provides application tips or other useful information to
assure that you get the most from your equipment.

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6 Regulatory Information
6.1 Medical Device Compliance
The CE Mark and Notified Body registration number signifies that
this equipment is in compliance with the essential requirements
of the EU Regulation 93/42/EEC (MDD) by declaration of the
manufacturer.
6.2 Radio Frequency Compliance
The CE Mark signifies that this equipment is in compliance with
the essential requirements and other relevant provisions of the
EU Regulation 2014/53/EU (RED) by declaration of the
manufacturer.
6.3 Medical Device Classification
MDD: Class IIa.
Protection against electric shock: Type BF, non-defibrillation-proof
applied part.
Mode of operation: Continuous operation.
Method(s) of sterilization recommended by the manufacturer: Not
applicable.

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7 Labeling
7.1 Symbols
The following symbols appear on the device and / or on the
packaging:
CardioMem CM 100 XT
Device Type (CardioMem CM 100) and
model (XT),
2017-03-22
Name and address of the manufacturer.
Below the solid factory symbol is the date
on which the device was manufactured.
Next to the solid factory symbol is the
name of the manufacturer.
UDI Label; matrix code with GTIN (1), date
of manufacturing (02), device identifier
[SN] (21) and device catalogue number
[REF] (241)
Barcode with Kit catalogue number [REF]
CE marking, followed by the certification
number of the notified body of the
manufacturer.
The symbol informs medical professionals
that the device is classified as “body
floating” (BF) and that it is NOT protected
against defibrillation.
IP64
The ingress protection classification of the
device is IP64, whereby 6 = dust proof, 4 =
protected against splashing water.