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
78812021-EN CardioMem®CM 100 XT 5
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
6 CardioMem®CM 100 XT 78812021-EN
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.
78812021-EN CardioMem®CM 100 XT 7
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.
8 CardioMem®CM 100 XT 78812021-EN
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.
78812021-EN CardioMem®CM 100 XT 9
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.
10 CardioMem®CM 100 XT 78812021-EN
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.
78812021-EN CardioMem®CM 100 XT 11
The symbol indicates that the device is
powered by a replaceable, non-
rechargeable battery.
This symbol indicates that you must
dispose of the device properly. Further
information is provided in the section
“Disposing of the Device, Batteries or
Accessories“.
Follow the Instructions for Use. Read and
understand the operator's manual before
using the device or product.
General warning sign. Observe the
information in the operating manual for
proper use of the device.
Serial number.
REF (reference) number to identify and
order the product.
Push-button
Temperature Limits -20°C ... 60°C.
Indicates the upper and lower temperature
limits allowed for the device’s storage and
shipping.
Humidity Limits 0% ... 93%. Indicates the
upper and lower humidity limits allowed for
the device’s storage and shipping.
12 CardioMem®CM 100 XT 78812021-EN
Atmospheric pressure Limits 700hPa ...
1060hPa. Indicates the upper and lower
atmospheric pressure limits allowed for the
device’s storage and shipping.
Keep away from heat Indicates that you
need to keep the container away from
sources of heat.
Keep dry Indicates that you need to keep
the container away from rain and other
sources of moisture.
Fragile Indicates the contents are fragile
and should be handled with care.
Maximum stack size: 10 packages.
The packaging is capable of being
recycled.
14 CardioMem®CM 100 XT 78812021-EN
8 Safety Information
8.1 General Warnings
1. RISK OF CONTAMINATION OR INFECTION - Device and
accessories may be contaminated with bacteria or viruses after
use. If any contamination of the device or accessories has
occurred, observe the standard procedures for handling
contaminated objects and the following precautions:
Use protective gloves to handle the equipment.
Isolate the material by using suitable packaging and
labelling.
Contact the addressee before sending the equipment.
Clean and disinfect the device and accessories after
every use.
2. MIXING UP RECORDINGS - The patient’s life or health may
be put at risk if the Patient is assigned a different patient’s
examination, thus resulting in an incorrectly assigned diagnosis.
To ensure that a recording is not assigned to the wrong patient,
always make sure that the device memory has been deleted
before the device is used in the next patient.
3. NO MONITORING DEVICE - The device is not intended for
monitoring the clinical condition of a person.
4. ELECTRIC SHOCK or device malfunction may occur if
electrodes contact conductive materials. Keep the conductive
parts of lead electrodes and associated parts away from other
conductive parts, including earth. Also make sure that no contact
to other conductive parts is possible if the electrodes loosen
during recording.
5. ELECTROMAGNETC EMISSIONS - Use of accessories and
cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
6. ELECTROMAGNETC EMISSIONS - Electrical medical
equipment should be used no closer than 30 cm (12 inches).
78812021-EN CardioMem®CM 100 XT 15
Otherwise, degradation of the performance of this equipment
could result.
7. ELECTROMAGNETIC RADIATION - Portable RF
communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer
than 30 cm (12 inches). Otherwise, degradation of the
performance of the device could result.
8. ELECTROMAGNETC COMPATIBILITY - Use of this
equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation.
9. SERVICE AND REPAIR - The device must not be serviced or
repaired while in use.
8.2 General Cautions
1. General hazard - The device must not be used if mechanically
damaged.
2. General hazard - The device must not be used if the battery
compartment door is lost. Replace the battery compartment door
before the device will be used.
3. General hazard - Before starting a recording, make sure that
the battery compartment door is closed and latched.
4. Risk of choking –Small parts can pose a choking hazard. Keep
such parts out of children's reach.
5. Infection risk –Reuse of disposable parts that come into
contact with patients pose a risk of infecting patients. Do not
reuse disposable parts that have had direct contact with the
patient, such as ECG electrodes.
6. Infection risk –Returning parts and products that have not
been disinfected exposes our service personnel to a risk of
infection.
16 CardioMem®CM 100 XT 78812021-EN
7. Protect the device against mechanical damage by shocks,
pressure and scratches. Otherwise, the correct functioning of the
device can no longer be guaranteed.
8. Malfunction or damage of the device –Changes in temperature
and humidity can cause condensation inside the device. Wait at
least two hours after the externally visible dampness of the device
has disappeared before reusing it.
9. Malfunction or damage of the device –Remove the battery
when the device is not used for a longer period of time.
10. Risk of skin irritation - ECG electrodes may cause skin
irritation if used for a very long time.
11. Electrosurgery –There is a risk of burns and injury to the
patient. If an electrosurgery device is used, disconnect the ECG
electrodes from the device.
12. Replacement of battery - Use only batteries of the type
Renata CR2477N. The use of a different type of battery can
cause damage or malfunction. Replacement by inadequately
trained personnel could result in a hazard (such as excessive
temperatures, fire or explosion).
13. Wet environments - The device is protected against splashing
water. Nonetheless it should not be worn under the shower. You
must not wear the device when swimming or bathing. The ingress
of water can cause damage or malfunction.
14. The device and accessories must not be sterilized.
15. Cleaning and disinfection - Do not use solvents such as ether,
acetone, or petroleum ether; such substances can damage the
plastic of the device's housing.
16. Disposal of batteries - Do not dispose batteries together with
the normal waste. You are required to dispose of any batteries in
accordance with local and national regulations.
17. Safe and reliable operation of the device is only possible
when using the supplied and approved accessories.Repair and
Maintenance - Repairs must be carried out only by persons
authorized by the manufacturer.
78812021-EN CardioMem®CM 100 XT 17
18. Repair by inadequately trained personnel could result in a
hazard, e. g. excessive temperatures or high voltages.
Replacement of the electrodes and of the battery can be done by
the patient.
19. Malicious software –Software delivered is scanned for viruses
but can, nevertheless, be intruded by malicious software. We
recommend the following: Install a good quality virus scanning
program and regularly up-date it. Establish procedures to avoid
infected software reaching your computer in the first place, e.g.,
check the source of any software you use and use only original
software packages.
20. Downloading data via USB - The download of data should be
performed by a medical professional after the patient has
returned the device. This operation should not be performed by
the Patient.
18 CardioMem®CM 100 XT 78812021-EN
9 Warranty and Service Information
Only authorized service personnel should repair the device. Any
unauthorized attempt to repair equipment under warranty voids
that warranty.
The device does not require any special service to maintain its
safety and performance during the expected service life.
It is the operator’s responsibility to report the need for repair to
the manufacturer or to one of his authorized agents. If you find or
even suspect a malfunction, send the device for testing to the
address shown below. Please add a detailed description of the
observed malfunction.
In case of an unexpected operation or event or if you need
technical support contact the manufacturer at the address shown
below.
GETEMED Medizin- und Informationstechnik AG
Oderstr. 77, 14513 Teltow, Germany
www.getemed.de
10 Cleaning and Desinfection
CAUTION: Do not use solvents such as ether, acetone or
petroleum ether; such substances can damage the plastic of the
device's housing.
CAUTION: Remove the battery and close the battery
compartment door before cleaning or disinfecting the device.
Clean the device before performing surface disinfection. Use a
lint-free cloth slightly moistened with water or a mild soap solution
to wipe the device.
Disinfect the device at regular intervals, prior to first use, and
before passing it on to another person. GETEMED recommends
disinfecting the device with a 70 % alcohol solution.
78812021-EN CardioMem®CM 100 XT 19
11 Operating Elements
The device features a push-button (1), a LED (2) and a speaker
(Figure 3).
The push-button is marked with the following symbol:
11.1 Event Button
The push-button is used to perform the following functions:
Function
User Action
Switch on the device
Press and hold for more than a second until a
beep sounds.
NOTE:
The device cannot be turned off unless the
battery is removed.
Start a recording
Press and release. A double beep will sound to
confirm the recording has started.
Mark an event
during recording
Mark an event during recording.
Figure 3 –Operating elements
20 CardioMem®CM 100 XT 78812021-EN
11.2 LED
This multi-color LED indicates the device status:
Device status
Status indicator
Ready for recording
Shining green
Recording in progress
Flashing green
Open lead
Flashing yellow
Contains recording
Shining yellow
Low battery
Flashing red
USB connected
Shining cyan
Error
Flashing green, red, blue and flashing red
afterwards
For a detailed description of all notifications refer to section
"Notifications (LED and Speaker)".
11.3 Signaltöne
The device provides the following audible feedback:
Device status
Notification
Button pressed
Single beep
Open lead
Three beeps
User interaction required / check
device state
Three beeps
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