getemed PhysioMem PM 100 4G User manual

Instructions for Use
PhysioMem® PM 100 4G
Tele-ECG Event Recorder
Revision 03 EN
Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring

77814021 - EN PhysioMem PM 100 4G 3
Contents
1Information about this Manual............................................................4
2Intended Purpose ................................................................................5
3Indications and Contraindications ......................................................5
4Regulatory information .......................................................................6
5Classifications......................................................................................6
6Labelling ..............................................................................................7
7Safety Information ...............................................................................9
7.1 Definitions...................................................................................9
7.2 General Warning Notes............................................................10
7.3 General Precautions.................................................................12
7.4 Incident Reporting....................................................................14
8Warranty and Service Information....................................................15
8.1 Maintenance and Repair ..........................................................15
8.2 Cleaning and Disinfection ........................................................15
9Operation............................................................................................17
9.1 Operating elements..................................................................17
9.2 Visual and acoustic signals ......................................................18
9.3 Lead Scheme ............................................................................21
9.4 Startup and Shutdown..............................................................21
9.5 Charging the Battery ................................................................23
9.6 How to apply the Device ...........................................................26
9.7 Recording an ECG.....................................................................28
9.8 Automatic Transmission ..........................................................29
9.9 PhysioMem PM 100 4G and ReSTA..........................................32
10 ECG Report.........................................................................................33
11 Patient Information............................................................................35
12 Disposal of Device and Accessories..................................................36
13 Troubleshooting.................................................................................37
13.1 Error Codes ..............................................................................37
13.2 Common Problems ..................................................................38
14 Information regarding Consumables and Accessories ...................40
15 Specifications.....................................................................................41
15.1 PhysioMem PM 100 4G –General............................................41
15.2 Wireless Charging Pad –General............................................42
15.3 Operating conditions ................................................................42
15.4 Transport and Storage Conditions...........................................43
15.5 Electromagnetic Compatibility (EMC)......................................43
16 List of figures.....................................................................................49

4 PhysioMem PM 100 4G 77814021 - EN
1Information about this Manual
This manual is published by:
GETEMED Medizin- und Informationstechnik AG
Oderstr. 77, 14513 Teltow, Germany
www.getemed.de
The information provided in this manual applies to
PhysioMem PM 100 4G, version 2.x.x. It does not apply to earlier
versions.
Adobe Acrobat and Reader are either registered trademarks or
trademarks of Adobe Systems Incorporated in the United States
and/or other countries.
PhysioMem is a trademark owned by GETEMED Medizin- und
Informationstechnik AG.
Other company and product names mentioned herein are trade-
marks of their respective companies.
Revision History
Revision
Publication Date
Description
01
2021-11-30
1st edition
02
2022-02-25
2nd edition - Cautions
and symbols revised
03
2023-05-03
3rd edition –Updated
description of the
screens, the general
specification and the
ECG lead scheme

77814021 - EN PhysioMem PM 100 4G 5
2Intended Purpose
The PM 100 device is a two-channel cardiac event recorder for
transmitting multiple event recordings via cellular telephony net-
works to a compatible receiving system, such as ReSTA from
GETEMED. The device is intended for patient activated record-
ings. The PM 100 is intended to be used in both home environ-
ments and clinical environments. Home environments include ur-
ban/suburban/ rural, school/office/retail environments, and vehi-
cles like trains and cars. Airplanes are excluded as long as the
use of cellular radio equipment is not allowed during flight. The
device is battery-driven and utilizes a FLASH memory to store
ECG data. The PM 100 is not intended to be used as a critical care
monitoring system and should not be used in emergency situa-
tions.
3Indications and Contraindications
The PM 100 is indicated for the diagnostic evaluation of adult and
pediatric (over 10 kg body weight) patients with asymptomatic and
symptomatic disturbances of the cardiac rhythm and for the eval-
uation of recurrent unexplained episodes of racing heart, syn-
cope, palpitations or dizziness. Patients with an age of less than
14 years need support from adults.
The device is not indicated for patients whose clinical condition
requires continuous monitoring of vital physiological parameters,
where the nature of variations is such that it could result in im-
mediate danger to the patient.

6 PhysioMem PM 100 4G 77814021 - EN
4Regulatory information
The CE Mark and Notified Body Registration Number signifies the
device including its accessories meets all general safety and per-
formance requirements of the Medical Device Regulation (EU)
2017/745.
The CE Mark also signifies the device including its accessories
meets all essential requirements of the Radio Equipment Di-
rective 2014/53/EU.
5Classifications
MDR (EU) 2017/745 classification
Class IIa
Protection against electric shock
Type CF (Cardiac Floating), non-
defibrillation-proof applied part
Mode of operation
Continuous
Method(s) of sterilization recom-
mended by the manufacturer
Not applicable
Use classification
Multiple patients multiple use

77814021 - EN PhysioMem PM 100 4G 7
6Labelling
The following symbols appear on the device type label and / or on
the packaging label:
Symbol
Description
PhysioMem
Device type
Symbol "Model number identifier"
PM 100 4G
Model type
Symbol "Serial number"
840 YY XXXXX
Serial number of device
Symbol "Catalogue number"
77214001
Model catalogue (REF) number
2021-11-30
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.
Symbol "Distributor"
Next to the symbol is the name and the
address of the distributor.
Symbol "Country of origin"
"DE" indicates that the product is made in
Germany.
MADE IN GERMANY
Country of origin

8 PhysioMem PM 100 4G 77814021 - EN
Symbol
Description
CE marking, followed by the certification
number of the Notified Body of the manu-
facturer.
Symbol "Non ionizing radiation"
Symbol "Applied part type"
The symbol informs medical professionals
that the device is classified as “cardiac
floating” (CF) and that it is NOT protected
against defibrillation.
Symbol "Medical Device"
LiPo 3.7 V / 880 mAh
Symbol "Rechargeable battery"
The symbol indicates that the device is
powered by a rechargeable battery.
IP64
The ingress protection classification of the
device is IP64, whereby 6 = dust proof, 4 =
protected against splashing water.
This symbol indicates that you must dis-
pose of the device properly. Further infor-
mation is provided in the section “Disposal
of Device and Accessories“.
Symbol "Unique Device Identifier"
(01) 04250903202513
(11) 201121
(21) 8401400001
(241)77214001
UDI Label; matrix code with GTIN (01),
date of manufacturing (11), device identi-
fier [SN] (21) and device catalogue number
[REF] (241)

77814021 - EN PhysioMem PM 100 4G 9
Symbol
Description
Symbol " Read instructions for use"
Read and understand the operator's man-
ual before using the device.
-20°C to 60°C
Temperature limits -20 °C ... 60 °C.
Indicates the upper and lower tempera-
ture limits allowed for the device’s storage
and shipping.
5%RH to 95%RH
Humidity limitation 5 % ... 95 %.
Indicates the upper and lower humidity
limits allowed for the device’s storage and
shipping.
Symbol "Fragile"
Indicates the contents are fragile and
should be handled with care.
Symbol "Keep dry" Indicates that you need
to keep the container away from rain and
other sources of moisture.
Symbol "Recycling"
The packaging is capable of being recy-
cled.
7Safety Information
7.1 Definitions
The terms “Warning”and “Caution”are used in these Instruc-
tions for Use to indicate hazards and the degree of severity. A
hazard is defined as a potential source of harm, harm being de-
fined as injury or damage to the health of people, or damage to
property or the environment.

10 PhysioMem PM 100 4G 77814021 - EN
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 maximum benefit from the product.
7.2 General Warning Notes
WARNING
MIXING UP RECORDINGS
The patient’s life or health may be put at risk if the pa-
tient is assigned a different patient’s ECG recording thus
resulting in an incorrectly assigned diagnosis.
Take special care to always select the correct examina-
tion and the correct patient.
Before the device is given to another patient, check that
there are no more recordings stored on the device.
WARNING
STRANGULATION BY THE NECK LANYARD
Neck lanyards present a possible strangulation risk.
Do not wear the device with the neck lanyard around
your neck while you are sleeping.
WARNING
RISK OF CONTAMINATION OR INFECTION
Device and accessories may be contaminated with bacte-
ria or viruses after use.
If any contamination of the device or accessories has oc-
curred, 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 labeling.
Contact the addressee before sending the
equipment.
Clean the device and accessories after every
use.

77814021 - EN PhysioMem PM 100 4G 11
WARNING
NOT A MONITORING DEVICE
The PhysioMem PM 100 4G is not a monitoring device
and is not intended for monitoring the clinical condition
of a patient.
Do NOT use the PhysioMem PM 100 4G as a monitoring
device.
WARNING
EXPLOSION HAZARD
Electrical sparks can cause explosions in the presence of
certain gases.
Do not use device in an oxygen-enriched environment or
around other flammable or explosive gases. Establish
whether the patient is liable to be in such an
environment, possibly for job-related reasons.
WARNING
MALFUNCTION OF PACEMAKERS AND ICD
The device has an integrated mobile transmission mod-
ule. Active mobile transmission devices in the close vi-
cinity of pacemakers and implantable cardioverters/de-
fibrillators (ICD) can cause malfunctioning of these de-
vices. Do not place the device in the breast pocket of your
shirt. Keep it at least 15 cm away from your implanted
device after the recording. Patients with pacemakers or
ICDs must not use the supplied neck lanyard to carry the
device.
WARNING
EXTREME TEMPERATURES
The device performance may be compromised at ex-
treme temperatures.
If the device has been stored at a temperature close to
the extreme hot or cold limit, wait at least 4 hours for the
device to reach ambient temperature before use.
WARNING
HOUSEHOLD PETS AND VERMIN
Household pets and vermin may pose a risk to patient
safety.
Protect the device and accessories against contact with
household pets, pests and children, as they could cause
safety related damage to it, e.g., by biting it, letting it
drop, exposing it to fluids or dirt.

12 PhysioMem PM 100 4G 77814021 - EN
7.3 General Precautions
CAUTION
ELECTROMAGNETIC EMISSIONS
While acquiring data do not use mobile phones or other
electrical equipment such as computers or electrical
tools close to the device. That may cause interference.
CAUTION
ELECTROMAGNETIC EMISSIONS
Switch off the device in locations where the use of mobile
network devices is totally or at times forbidden (e.g., in-
tensive care unit, airplane).
CAUTION
HUMID ENVIRONMENTS
The temperature of the device must not go below 5 °C or
above 45 °C. Do not expose the device to sudden temper-
ature or humidity changes. Quick changes in tempera-
ture or humidity can cause condensation. Do not bring
the device into the proximity of heat sources, such as
heaters and ovens, and do not expose it to direct sun-
light.
CAUTION
DAMAGE OF DEVICE AND ACCESSORIES
Protect the device against mechanical damage by
shocks, pressure and scratches. Otherwise, the correct
functioning of the device can no longer be guaranteed.
CAUTION
DAMAGE OF DEVICE AND ACCESSORIES
Do not use the device in the event of the packaging
being damaged, unintentionally opened before use or if
the packaging is exposed to environmental conditions
outside of those specified in this manual. Otherwise, the
correct functioning of the device can no longer be
guaranteed.
CAUTION
MALFUNCTION
Do not use the device if it has been damaged or has mal-
functions.

77814021 - EN PhysioMem PM 100 4G 13
CAUTION
UNAUTHORIZED ACCESS
In order to avoid a wrong assigning of ECG data, keep the
device protected against unauthorized access by third
persons.
CAUTION
CONDUCTIVITY
When wearing the device, ensure that the electrodes do
not contact other conductive parts including earth.
CAUTION
PROPER MAINTENANCE
Proper maintenance is vital for long-term safety and re-
liability of the device. Each time before giving the device
to a patient, visually check the device for damage.
CAUTION
SERVICE AND REPAIR
Repairs must be carried out only by persons authorized
by the manufacturer. If you find or even suspect a mal-
function, send the device for testing to the manufacturer
or a facility authorized by the manufacturer. Please add a
detailed description of the observed malfunction.
CAUTION
APPROVED ACCESSORIES
Safe and reliable operation of the device is only possible
when using the supplied and approved accessories.
CAUTION
INFECTION RISK
Returning parts and products that have not been disin-
fected exposes our service personnel to a risk of infec-
tion. For hygienic reasons, and especially to help protect
our service personnel, please disinfect the device before
returning them to us for inspection or maintenance.
CAUTION
ACCIDENTAL ACTIVATION
If the device is not in use, switch it off and store it with
care to prevent accidental activation. This could result in
incorrect ECG interpretation. Also, switch off the device
before shipping to prevent inadvertent data transmis-
sion.

14 PhysioMem PM 100 4G 77814021 - EN
7.4 Incident Reporting
Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and to the competent au-
thority.
A serious incident is a device malfunction that results in death
or serious injury, or may lead to death or serious deterioration in
state of health of an individual.

77814021 - EN PhysioMem PM 100 4G 15
8Warranty and Service Information
8.1 Maintenance and Repair
The device does not require any special maintenance to maintain
its safety and performance features during the expected life-time.
Only authorized personnel are allowed to repair the device. Any
unauthorized attempts to repair the device will make any war-
ranty claims null and void. It is the operator's responsibility to re-
port the need for repair to the manufacturer or one of his author-
ized representatives. If you determine or suppose any malfunc-
tion, send the device 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
8.2 Cleaning and Disinfection
Clean and disinfect the device at regular intervals, prior to first
use and before passing it on to another person.
CAUTION
Do not use solvents, such as ether, acetone or paraffin oil;
such substances can damage the material of the housing.
CAUTION
Do not submerge the device and the Wireless Charging
Transmitter Pad or allow fluid to enter the device and the
Wireless Charging Transmitter Pad under any circum-
stances.

16 PhysioMem PM 100 4G 77814021 - EN
CAUTION
Do not sterilize the device or accessories.
Switch off the device before cleaning and/or disinfection. Before
performing surface disinfection, clean the device. Use a lint-free
cloth slightly moistened with a mild soap solution to wipe the de-
vice.
GETEMED recommends to use a 70 % alcohol solution for disin-
fection. Please note the application time of the disinfectant (10
minutes for 70 % alcohol solution). Subsequently use a lint-free
cloth slightly moistened to remove remainders of the disinfectant.
The device withstands up to 700 cleaning / disinfection cycles (7
years of normal use). Re-processing by way of a machine is ex-
cluded for the product.
The product is not intended for sterilization. Store re-processed
products in a dust-free and dry place.
The instructions listed above have been validated by the medical
device manufacturer as being suitable for preparing the medical
device for reuse. It is the responsibility of the processor to ensure
that the processing actually carried out with the equipment, ma-
terials and personnel used in the processing facility achieves the
desired result. This requires verification and / or validation and
routine monitoring of the process.

77814021 - EN PhysioMem PM 100 4G 17
9Operation
9.1 Operating elements
On the front side the device features a pushbutton (1) for switch-
ing on / off and for starting a recording, and a display (2) for the
indication of operating modes and error codes. The pushbutton is
marked with the symbol (Figure 1).
Figure 1 - Pushbutton and display
The four electrodes for the ECG lead are positioned on the back of
the device (Figure 2).
Figure 2 - Electrodes

18 PhysioMem PM 100 4G 77814021 - EN
9.2 Visual and acoustic signals
The following symbols can be displayed:
Cellular radio is switched on, not con-
nected, searching for network
Device is attached to mobile network, signal
strength
Device connected to ReSTA server, signal
strength
Number of ECG in memory
Data transmission failure
Battery state - 20 %, 40 %, 60 %, 80 %, 100
% capacity
Charging of the battery required - recording
possible, transmission not possible until the
battery is recharged until 20 % capacity
Battery exhausted. Recording not possible
until the battery is recharged until 20 % ca-
pacity

77814021 - EN PhysioMem PM 100 4G 19
The device states are indicated by way of symbols on the display
and acoustic signals:
Device State
Display
Buzzer
Device is starting
1 x beep
Device is switching off
-
Status message is being transmitted
-
Device is ready for recording (cellular
radio is switched off, no data stored in
the device memory, battery is fully
charged)
-
Button pressed (recording started)
-
1 x beep
Recording in progress
1 single beep on
every recognized
heart beat

20 PhysioMem PM 100 4G 77814021 - EN
Device State
Display
Buzzer
Recording finished, transmission
starts
Rising sequence
of 4 x short
beeps
Automatic transmission of one ECG in
progress, device is searching for cel-
lular network
-
Automatic transmission of one ECG in
progress, device connected to ReSTA
server
-
Battery charging has started
-
2 x short beep
Battery charging in progress (battery
symbol is changing)
-
Error (see section "Troubleshooting"
in this manual for more information)
3 x short beep