getemed CardioMem CM 100 XT User manual

Instructions for Use
CardioMem® CM 100 XT
ECG Loop Recorder
Revision 05 EN
Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring

78812021-EN CardioMem®CM 100 XT 3
Contents
1Information about this Manual...............................................5
2Intended use..........................................................................6
3Indications and contraindications ..........................................7
3.1 Indications......................................................................7
3.2 Contraindications...........................................................7
4Regulatory information ..........................................................8
4.1 MDR compliance ...........................................................8
4.2 Radio frequency compliance.........................................8
4.3 Classifications................................................................8
5Labelling ................................................................................9
6Safety information................................................................12
6.1 Definitions....................................................................12
6.2 General warning notes ................................................12
6.3 General precautions ....................................................15
6.4 Incident Reporting .......................................................19
7Warranty and service information........................................20
8Cleaning and disinfection ....................................................21
9Operating elements .............................................................22
9.1 Pushbutton...................................................................22
9.2 Visual and acoustic signals .........................................23
9.3 Lead scheme...............................................................24
10 Preparing the recording.......................................................25
10.1 Inserting the battery.....................................................25
10.2 Instructing the patient ..................................................27
10.2.1 Saving an event manually ...................................27
10.2.2 Recording diary....................................................28
10.2.3 Medical Emergency.............................................28
10.3 Preparing the skin of the patient..................................28
10.4 Connecting the electrodes to the recorder ..................29
10.5 Attaching the device to the patient ..............................30
10.6 Turning on the recorder...............................................31
10.7 Checking the signal quality..........................................31
11 Recording an event .............................................................32
11.1 Manual recording by pressing the pushbutton ............32
11.2 Automatic recording.....................................................32
11.2.1 Automatic detection of arrhythmias.....................32
11.2.2 Time-triggered recording .....................................33
12 End of recording ..................................................................34
12.1 Removing the electrodes.............................................34
13 Using the CM 100 Configurator software ............................35

4 CardioMem®CM 100 XT 78812021-EN
13.1 Required hardware and software ................................35
13.2 Installation....................................................................36
13.3 Checking the system time............................................37
13.4 Connecting the USB download cable to recorder
and PC.........................................................................38
13.5 Turning on the recorder...............................................39
13.6 Starting the CM 100 Configurator software .................40
13.7 The “Information” screen .............................................41
13.8 The “Download” window; downloading a recording.....42
13.8.1 Selecting a folder and starting the download.......42
13.8.2 Deleting data on the recorder ..............................43
13.9 The “Setup” window.....................................................43
13.9.1 Pre- and post-event times....................................45
13.9.2 Settings for automatic detection of events...........45
13.10 The “Default settings” window .....................................46
13.11 Disconnecting the recorder..........................................47
13.12 Licence information......................................................47
13.13 Importing recordings with CardioDay®.........................47
14 Displaying the ECG report...................................................48
14.1 Information contained in the ECG report.....................48
15 Description of the “Tele ECG” mode ...................................51
15.1 General information .....................................................51
15.2 Starting the PhysioGate App .......................................53
15.3 Operating the PhysioGate App....................................54
15.4 Bluetooth pairing..........................................................55
15.5 Checking the transmission...........................................58
15.6 Licence information......................................................59
15.7 Data privacy information..............................................59
16 Description of automatic rhythm detection ..........................60
16.1 Heart rate detection .....................................................60
16.2 Detection of bradycardia and tachycardia ...................60
16.3 Detection of atrial fibrillation (AFib)..............................61
16.4 Pause detection...........................................................61
17 Disposal of device, batteries and accessories.....................62
18 Troubleshooting...................................................................63
19 Information regarding consumables and accessories.........69
20 Specifications.......................................................................70
20.1 General........................................................................70
20.2 Electromagnetic compatibility......................................72
21 List of figures .......................................................................77

78812021-EN CardioMem®CM 100 XT 5
1 Information about this Manual
This Manual was published by
GETEMED Medizin- und Informationstechnik AG
Oderstr. 77, 14513 Teltow, Germany.
The information provided in this Manual applies to CardioMem
CM 100 XT, version 1.1.x, and CM 100 Configurator, version
1.3.x. It does not apply to earlier versions.
Microsoft and Windows are either registered trademarks or trade-
marks of Microsoft Corporation in the United States and/or other
countries. Adobe Acrobat and Reader are either registered trade-
marks or trademarks of Adobe Systems Incorporated in the
United States and/or other countries. Android is a brand of
Google LLC. The Bluetooth®word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc., and any use of such
marks by GETEMED is under license.
CardioMem, CardioDay and PhysioGate are trademarks owned
by GETEMED.
Other company and product names mentioned herein are trade-
marks of their respective companies.
Revision history
Revision
Publication date
Description
01
2017-11-10
1st edition
02
2018-03-06
2nd edition
03
2019-09-09
3rd edition: Contents for Tele ECG
and modified housing added
04
2020-02-01
4th edition: Symbol RCM and accesso-
ries added
05
2021-10-25
5th edition: Compliance with Medical
Device Regulation (EU) 2017/745

6 CardioMem®CM 100 XT 78812021-EN
2 Intended use
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 on patients whose symptoms oc-
cur infrequently;
Document the impact of an initiating drug therapy for ar-
rhythmias;
Document the recurrence of arrhythmias after discontinu-
ation of a drug therapy;
Document the results after an ablation procedure for ar-
rhythmias;
Evaluate syncopes on patients whose symptoms occur
infrequently.
The ECG recording is triggered either manually by the patient or
automatically by a programmed timer or by way of an algorithm
that can detect the following arrhythmias:
Tachycardia
Bradycardia
Atrial fibrillation
Pause
The device is intended for use in home and clinical environments.
Home environments include rural, urban and suburban residential
areas, as well as schools, offices and retails environments. The
device may also be used during transport. The device is not in-
tended for use near active RF surgical equipment or in shielded
rooms of magnetic resonance imaging (MRI) system. The device
is battery-powered and uses a non-volatile memory to store the
ECG data. The device is not intended for use as a critical care
monitoring system and must not be used in emergency situations.

78812021-EN CardioMem®CM 100 XT 7
3 Indications and contraindications
3.1 Indications
CardioMem CM 100 XT is intended for adult and pediatric pa-
tients (weight >10 kg) who require monitoring of the following car-
diac arrhythmias: Tachycardia, bradycardia, atrial fibrillation, and
pause.
3.2 Contraindications
Contraindications include the use on patients
With known allergies or hypersensibilities to adhesives or
hydrogels;
With potentially life-threatening arrhythmias, or
Who require inpatient / hospital monitoring.

8 CardioMem®CM 100 XT 78812021-EN
4 Regulatory information
4.1 MDR compliance
The CE Mark and Notified Body Registration Number signifies the
device including accessories meets all general safety and perfor-
mance requirements of the Medical Device Regulation
(EU) 2017/745 (MDR).
4.2 Radio frequency compliance
The CE Mark signifies the device including accessories meets all
essential requirements of the Radio Equipment Directive
2014/53/EU (RED).
4.3 Classifications
(EU) 2017/745 (MDR) classification
Class IIa
Protection against electric shock
Type BF, non-defibrillation-
proof applied part
Mode of operation
Continuous
Method(s) of sterilisation recom-
mended by the manufacturer
Not applicable

78812021-EN CardioMem®CM 100 XT 9
5 Labelling
The following symbols are used on the recorder and / or on the
packaging:
CardioMem CM 100 XT
Device type (CardioMem CM 100),
model (XT)
2017-03-22
The name and address of the manufac-
turer are specified to the right of this sym-
bol.The date of manufacture is specified
below the manufacturer symbol.
UDI marking comprising the matrix code
with GTIN (01), date of manufacture (11),
device serial number [SN] (21) and the or-
der number [REF] (241)
Barcode with kit order number [REF]
CE mark followed by the registration num-
ber notified body of the manufacturer
This symbol informs medical experts that
the recorder is protected against electric
shock in accordance with the class of pro-
tection “Body floating”(BF) and NOT pro-
tected against defibrillation.
IP64
This symbol indicates that the device is
protected in accordance with IP64 against
the ingress of fluids and foreign matters; 6
= dust-protected, 4 = protection against
splash water.
This symbol indicates that the recorder is
powered by a replaceable, non-rechargea-
ble battery.

10 CardioMem®CM 100 XT 78812021-EN
This symbol refers to the obligation to dis-
pose of the recorder in accordance with
the relevant environmental regulations.
For further information, refer to the “Dis-
posal of device, batteries and accessories”
section on page 62.
Observe the Instructions for Use.
Before starting work with the recorder,
make sure that you have read and under-
stood the Instructions for Use.
General warning sign
Observe the information in the Instructions
for Use for proper use of the device.
Serial number
REF (catalogue) number for identification
and ordering of the product
Pushbutton
Temperature range –20 °C ... 60 °C
Specifies the upper and lower limits for the
permissible temperature during storage
and transport
Humidity range 0% ... 93%
Specifies the upper and lower limits for the
permissible humidity during storage and
transport
Atmospheric pressure range 700 hPa ...
1,060 hPa
Specifies the upper and lower limits for the
permissible atmospheric pressure during
storage and transport

78812021-EN CardioMem®CM 100 XT 11
Keep away from heat
Indicates that the recorder must be kept
away from heat sources
Keep dry
Indicates that the recorder must be kept
away from rain and other sources of mois-
ture
Fragile
Indicates that the contents are fragile and
should be handled with care
Maximum stacking height: 10 boxes
The packaging is recyclable.
RCM (Regulatory Compliance Mark –
Australia & New Zealand)
Indicates that the product is a medical
device
Unique device identifier
Indication of the entity distributing the
medical device into the locale
Identification of the country of manufacture
of products

12 CardioMem®CM 100 XT 78812021-EN
6 Safety information
6.1 Definitions
The terms “Warning”and “Caution”are used in these Instructions
for Use to indicate hazards and the degree of severity. A 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 risk or unsafe practice which, if
not avoided, could result in minor personal injury or damage to
the product or property.
NOTICE indicates application notes or other useful information to
ensure that you get the most from the product.
6.2 General warning notes
WARNING NO MONITORING DEVICE
The recorder is not intended for monitoring of the
clinical condition of a person.
Do not use CardioMem CM 100 XT as a monitor-
ing device.
WARNING MIXING UP RECORDINGS
The patient's life or health can be put at risk if the
patient is assigned an examination of a different
patient, resulting in an incorrectly assigned diag-
nosis.
Make sure that no recordings are saved in the de-
vice before the recorder is used for the next pa-
tient.
WARNING ELECTROSURGERY
There is the risk of burns and injury hazards for
the patient.

78812021-EN CardioMem®CM 100 XT 13
Always disconnect the recorder form the patient
before using an electrosurgical device.
WARNING EXPLOSION HAZARD
Electrical sparks can cause explosions in the
presence of certain gases.
Do not use the recorder in an oxygen-enriched
environment or in the vicinity of flammable or ex-
plosive gases.
First check whether the patient is liable to be in
such an environment, e.g. for job-related reasons.
WARNING ELECTRIC SHOCK
An electric shock or malfunction can occur if the
electrodes come into contact with electrically con-
ductive materials.
Always keep the contacts of the electrodes away
from other conductive parts, including earth.
Make sure that no contact to other conductive
parts is possible if the electrodes loosen during
recording.
WARNING GENERAL HAZARDS FOR THE PATIENT
The instructions provided in these Instructions for
Use do not supersede the notes regarding recog-
nised medical practices of medical care.
Always observe the recognised medical practices
for medical care.
WARNING RISK OF CONTAMINATION OR INFECTION
The recorder or its accessories could be contami-
nated with bacteria or viruses after use.

14 CardioMem®CM 100 XT 78812021-EN
If so, observe the following standard procedures
for handling contaminated objects and the follow-
ing safety notes:
Always use protective gloves when
touching the equipment.
Isolate the material by using appropriate
packaging and labelling.
Contact the addressee and label the
packaging accordingly before shipping
the equipment.
Clean and disinfect device and accessories after
each use.
WARNING HAZARD OF SUFFOCATION
Small parts and packaging material represent a
suffocation hazard.
Make sure that small parts are always out of the
reach of children.
WARNING ELECTRIC SHOCK
Before starting cleaning or maintenance work,
first disconnect the recorder from the patient.
WARNING EXTREME TEMPERATURES
The performance of the device can be impaired in
case of extreme temperatures.
If the recorder has been stored at a temperature
close to the upper or lower limit, wait at least 4
hours to allow the recorder to reach ambient tem-
perature.
WARNING PETS AND VERMIN
Pets and vermin may entail a risk for the safety of
the patient.

78812021-EN CardioMem®CM 100 XT 15
For example, pets can cause damage from biting
or exude fluids over the recorder and its accesso-
ries. Vermin can also cause damage impairing
the functioning of the device.
Make sure that no pets or vermin come into con-
tact with the device or its accessories.
6.3 General precautions
CAUTION CONDUCTIVITY
Do not use the recorder if mechanically damaged.
Send the recorder to an authorised workshop for
repair.
CAUTION CONDUCTIVITY
Do not use the recorder if the cover of the battery
compartment is missing.
Fit the cover before using the recorder.
CAUTION RISK OF INFECTION AND CONTAMINATION
Reusing consumables that came into contact with
the patient entails the risk of infecting further pa-
tients.
Do not use consumables (e.g. electrodes) if they
have already been used for a patient.
CAUTION RISK OF INFECTION AND CONTAMINATION
Returned parts and products that have not been
disinfected entail the risk of infection for our ser-
vice personnel.
Especially for protection of our service personnel,
always disinfect both the recorder and the USB
cable before you send it to us for inspection or
maintenance.

16 CardioMem®CM 100 XT 78812021-EN
CAUTION DAMAGE TO THE DEVICE ARISING FROM
LEAKING BATTERIES
Batteries may leak if not used for longer.
Always remove the battery from the recorder if
you intended not to use the recorder for longer
than a week.
CAUTION INSUFFICIENT RECORDING QUALITY
Damaged recorders or accessories can lead to in-
sufficient ECG quality.
Check the recorder each time before you connect
recorder and electrodes to the patient.
CAUTION MALFUNCTION OR DAMAGE OF THE RE-
CORDER
Any changes in temperature or humidity can
cause formation of condensate inside the re-
corder.
Allow the recorder to become dry and wait an-
other two hours before starting work.
CAUTION DAMAGE TO THE RECORDER
Only the battery compartment of the recorder may
be opened, not the recorder itself!
Do not apply force when handling the recorder.
CAUTION SAFETY ONLY WITH APPROVED ACCESSO-
RIES
Safe and reliable operation of the recorder is only
possible when using the supplied and approved
accessories.
Observe the information provided in these In-
structions for Use and in the instructions delivered
with the accessories.

78812021-EN CardioMem®CM 100 XT 17
CAUTION SAFETY AND RELIABILITY ONLY WITH
PROPER MAINTENANCE
Proper maintenance is vital for long-term safety
and reliability.
Observe the information provided in this Manual
to ensure proper maintenance.
CAUTION DAMAGE TO DEVICE AND ACCESSORIES
Unauthorised personnel do not have the proper
training required to repair the recorder. Repairs
performed by unauthorised personnel can lead to
damage on the device or its accessories.
If you determine or suppose any malfunctions or
defects, send the recorder to an authorised work-
shop for checking. Please enclose a detailed de-
scription of the noticed malfunction.
CAUTION ADVERSE ENVIRONMENTAL IMPACTS
Electrical devices and accessories contain metal
and plastic parts which must be disposed of
properly.
Dispose of the recorder and its accessories in ac-
cordance with the applicable local and national
waste regulations after expiry of the product life-
time.
CAUTION POSSIBLE LOSS OF ECG RECORDING OR
POOR SIGNAL QUALITY
The recorder might be used with insufficient re-
sults if the patient does not have all relevant infor-
mation.
It is the responsibility of the doctor to provide the
patient with the information required for the ECG

18 CardioMem®CM 100 XT 78812021-EN
recording. For further information, see Section
“Instructing the patient”.
CAUTION ELECTROMAGNETIC EMISSIONS
The use of accessories other than those specified
or provided by the manufacturer could result in in-
creased electromagnetic emissions or decreased
electromagnetic immunity of the recorder, result-
ing in improper operation.
Only use the accessories specified and provided
by the manufacturer.
CAUTION ELECTROMAGNETIC EMISSIONS
Any other electromedical equipment in the vicinity
of the recorder can impair the performance of the
recorder.
Make sure that there is always is distance of at
least 30 cm (12 in) between the recorder and any
other electromedical equipment. The doctor must
inform the patient correspondingly where neces-
sary.
CAUTION MOIST ENVIRONMENTS
The ingress of water into the recorder can cause
damage or malfunctions. (The recorder is pro-
tected against splash water.)
The doctor is obliged to inform the patient that the
recorder must not be worn during swimming,
bathing or showering.

78812021-EN CardioMem®CM 100 XT 19
CAUTION REPAIR AND MAINTENANCE
Repair by inadequately trained personnel could
result in hazards, e.g. due to excessive tempera-
tures or high voltages. Only the electrodes and
battery may be replaced by the patient.
Repairs must only be performed by persons who
are authorised by the manufacturer to do so.
CAUTION MALICIOUS SOFTWARE
The delivered software is scanned for viruses, but
can, nevertheless, be intruded by malicious soft-
ware.
We recommend installation of an advanced anti-
virus software and regularly updating it.
Install appropriate procedures to prevent infected
software from reaching your computer. For exam-
ple, check the source of any software you use
and use only genuine software packages.
CAUTION DOWNLOADING DATA VIA USB
Data should only be downloaded by medical pro-
fessionals, not by the patient!
6.4 Incident Reporting
Any serious incident that has occurred in relation to the device
shall be reported to the manufacturer and the competent authority
of the Member State in which the user and/or the patient is estab-
lished.
A serious incident is a device malfunction that results in death or
serious injury, or may lead to death or serious deterioration of
health.

20 CardioMem®CM 100 XT 78812021-EN
7 Warranty and service information
Only authorised personnel are allowed to repair the recorder. Any
unauthorised attempts to repair the device will make any warranty
claims null and void.
The recorder does not require any special maintenance to main-
tain its safety and performance features during the expected life-
time.
It is the operator's responsibility to report the need for repair to
the manufacturer or one of his authorised representatives. If you
determine or suppose any malfunction, send the recorder for
checking to the address specified below. Please add a detailed
error description.
If you determine an unexpected operational condition or unex-
pected occurrences or if you need technical support, contact the
manufacturer under the following address:
GETEMED Medizin- und Informationstechnik AG
Oderstr. 77, 14513 Teltow, Germany
www.getemed.de