getemed PhysioMem PM 100 2G User manual

Cardiac Diagnostics,
Vital Signs Monitoring
Telemonitoring
Operating Manual
PhysioMem®PM 100 2G
Tele ECG Event Recorder

77811011 PhysioMem® PM 100 2G iii
Content
1Intended Use, Indications and Mode of Operation....................................5
1.1 Intended Use......................................................................................5
1.2 Indications..........................................................................................5
1.3 Mode of Operation .............................................................................6
2Regulatory Compliance and Labeling.......................................................7
2.1 Regulatory Compliance .....................................................................7
2.2 Product and Package Information ....................................................8
2.3 Additional Symbols on the Packaging Label...................................10
3Safety and Reliability ...............................................................................11
3.1 Definitions........................................................................................11
3.2 General Warnings............................................................................12
3.3 General Cautions .............................................................................14
3.4 Safety and Reliability Only with Proper Maintenance.....................15
3.5 Cleaning the Device and Accessories .............................................16
3.6 Disposing of the Device, Batteries, and Accessories .....................17
3.7 Established Medical Practices ........................................................18
3.8 Manufacturer Responsibility ...........................................................18
4Control Elements, Putting into Operation ..............................................19
4.1 Control Elements.............................................................................19
4.2 Putting into Operation, Fully Charging the Battery ........................20
5Recording and sending an ECG...............................................................25
5.1 How and where you apply the device ..............................................25
5.2 Recording an ECG............................................................................26
5.3 Sending an ECG Recording .............................................................28
5.4 Switching off the Device ..................................................................30
6The System of PhysioMem and ReSTA ...................................................31
6.1 Overview...........................................................................................31
6.2 ECG Report ......................................................................................32
7Meaning of Display Symbols and Audible Notifications .........................35
7.1 Display Symbols...............................................................................35
7.2 Audible Notifications .......................................................................37

iv PhysioMem® PM 100 2G 77811011
8Troubleshooting.......................................................................................38
8.1 Symptom, Cause, and Recommendation.........................................38
8.2 Error Codes Displayed.....................................................................39
9Accessories, Ordering Information.........................................................40
10 Specifications...........................................................................................41
10.1 Classification ...................................................................................41
10.2 General.............................................................................................41
10.3 ECG and Heart Rate.........................................................................41
10.4 Data Transfer...................................................................................42
10.5 Operation Conditions .......................................................................42
10.6 Storage and Transport Conditions ..................................................42
10.7 Charging Pad ...................................................................................42
10.8 Scope of Delivery .............................................................................43
10.9 EMC Specifications according to IEC 60601-1-2 ............................43
10.9.1 Guidance and manufacturer’s declaration –
electromagnetic emissions .........................................43
10.9.2 Guidance and manufacturer’s declaration –
electromagnetic immunity (line-bound disturbances)44
10.9.3 Guidance and manufacturer’s declaration -
electromagnetic immunity (Conducted and radiated RF
disturbances) ...............................................................46
Revision History
Revision
Publication Date
Description
A
2014-12-03
1st Publication
B
2015-01-20
Symbols and Labeling updated
C
2016-04-13
Symbols and Labeling updated
D
2016-08-11
Symbols and Labeling updated
E
2017-06-07
Update for RED compliance
F
2020-05-11
Update for revised standards

Intended Use, Indications and Mode of Operation
77811011 PhysioMem® PM 100 2G 5
1Intended Use, Indications and Mode of
Operation
These operating instructions are intended for medical professionals.
1.1 Intended Use
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 recordings.
The PM 100 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 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 situations.
1.2 Indications
The PhysioMem PM 100 2G is indicated for the diagnostic evaluation
of adult and pediatric (over 10 kg body weight) patients with asymp-
tomatic and symptomatic disturbances of the cardiac rhythm and for
the evaluation of recurrent unexplained episodes of racing heart,
syncope, 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 re-
quires continuous monitoring of vital physiological parameters,

Intended Use, Indications and Mode of Operation
6PhysioMem® PM 100 2G 77811011
where the nature of variations is such that it could result in immedi-
ate danger to the patient.
1.3 Mode of Operation
The patient places the device on his chest and activates the
recording by pressing the button. The device records short ECG
strips and transfers them to a central receiving system.
The transmission takes place wirelessly via the integrated GSM
module. The device is not intended for recording and transferring of
real-time data. Depending on the availability of the GSM or other
networks (e.g., the Internet), the transmission of the data can be
delayed.
The device runs on a rechargeable battery and stores ECG data in a
non-volatile FLASH memory.
A wireless charging transmitter pad is used to recharge the battery
of the device.

Regulatory Compliance and Labeling
77811011 PhysioMem® PM 100 2G 7
2Regulatory Compliance and Labeling
This section explains the symbols used in conjunction with the re-
corder.
2.1 Regulatory Compliance
The CE Mark and Notified Body Registration Number signifies the
device including accessories meets all essential requirements of the
Medical Device Directive 93/42/EEC.
The CE Mark signifies the device including accessories meets all es-
sential requirements of the Radio Equipment Directive 2014/53/EU.

Regulatory Compliance and Labeling
8PhysioMem® PM 100 2G 77811011
2.2 Product and Package Information
The symbols and content of the device labels is described below.
Fig. 1. Device label –PhysioMem PM 100
Fig. 2. Device label - Wireless Charging Transmitter Pad

Regulatory Compliance and Labeling
77811011 PhysioMem® PM 100 2G 9
The symbols have the following meanings:
Attention
Observe the information in the operating man-
ual for proper use of the device.
Follow instructions for use.
REF (reference) number to identify and order
the product.
Serial number
The heart symbol informs clinicians that the device
is classified as “cardiac floating” (CF) and that it is
NOT protected against defibrillation.
IP64
The ingress protection classification of the
PhysioMem is IP64, whereby 6 = dustproof and
4 = protected against splashing water
IP 21
The ingress protection classification of the
charging pad is IP21, whereby 2 = protected
against objects > 12.5 mm and 1 = protected
against dripping water
CE mark and registration number of the noti-
fied body
The symbol indicates that the device has an in-
tegrated lithium polymer LiPo rechargeable
battery.
This symbol indicates that you must dispose of
the device properly. Further information is pro-
vided in the section “Disposing of the Device,
Batteries, and Accessories”

Regulatory Compliance and Labeling
10 PhysioMem® PM 100 2G 77811011
Below the solid factory symbol is the date at
which the device was manufactured. Next to
the solid factory symbol is the name of the
manufacturer.
Non-ionizing electromagnetic radiation
FCC ID 2AOPN-
PM100
Federal Communications Commission Identifica-
tion
2.3 Additional Symbols on the Packaging Label
The symbols and content of the packaging label is described below.
The upper and lower temperature limits al-
lowed for the device`s storage and shipping
The upper and lower humidity limits allowed for
the device´s storage and shipping
Keep dry
Maximum stack size: 10 packages
Fragile, handle with care
Recycling

Safety and Reliability
77811011 PhysioMem® PM 100 2G 11
3Safety and Reliability
3.1 Definitions
The terms “warning” and “caution”are used throughout this manual
to point out hazards and to designate a degree or level of serious-
ness. 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.
With this symbol, the physician finds special
information or notes.

Safety and Reliability
12 PhysioMem® PM 100 2G 77811011
3.2 General Warnings
WARNING
MIXING UP RECORDINGS –The patient’s life or health may be put at
risk if the patient is assigned a different patient’s ECG recording
thus resulting in an incorrectly assigned diagnosis.
Take special care to always select the correct examination 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 –Recorder and accesso-
ries may be contaminated with bacteria or viruses after use.
If any contamination of the recorder 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 labeling.
Contact the addressee before sending the equipment.
Clean the device and accessories after every use. For information
refer to the section 3.5, page 16.

Safety and Reliability
77811011 PhysioMem® PM 100 2G 13
WARNING
NOT A MONITORING DEVICE –The PhysioMem PM 100 is not a mon-
itoring device and is not intended for monitoring the clinical condi-
tion of a patient.
Do NOT use the PhysioMem PM 100 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 inte-
grated mobile transmission module. Active mobile transmission de-
vices in the close vicinity of pacemakers and implantable cardiovert-
ers/defibrillators (ICD) can cause malfunctioning of these devices.
Do not place the device in the breast pocket of your shirt. Keep it at
least 15 cm away from your implanted device.
WARNING
EXTREME TEMPERATURES - The device performance may be
compromised at extreme 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.

Safety and Reliability
14 PhysioMem® PM 100 2G 77811011
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.
3.3 General Cautions
CAUTION
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
Switch off the device in locations where the use of mobile network
devices is totally or at times forbidden (e.g., intensive care unit,
plane).
CAUTION
The temperature of the device must not go below 5 °C or above 45 °C.
Do not expose the device to sudden temperature or humidity changes.
Quick changes in temperature 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 sunlight.

Safety and Reliability
77811011 PhysioMem® PM 100 2G 15
CAUTION
Protect the device against mechanical damage by shocks, pressure
and scratches. Otherwise, the correct functioning of the device can
no longer be guaranteed.
CAUTION
Do not use the device if it has been damaged or has malfunctions.
CAUTION
In order to avoid a wrong assigning of ECG data, keep the device pro-
tected against unauthorized access by third persons.
CAUTION
When wearing the device, ensure that the electrodes do not contact
other conductive parts including earth.
3.4 Safety and Reliability Only with Proper Maintenance
CAUTION
Proper maintenance is vital for long-term safety and reliability of the
device. Each time before giving the device to a patient, visually check
the device for damage.
CAUTION
Safe and reliable operation of the device is only possible when using
the supplied and approved accessories.

Safety and Reliability
16 PhysioMem® PM 100 2G 77811011
CAUTION
INFECTION RISK –Returning parts and products that have not been
disinfected exposes our service personnel to a risk of infection.
For hygienic reasons, and especially to help protect our service per-
sonnel, please disinfect the device before returning them to us for
inspection or maintenance.
CAUTION
If the device is not in use, switch it off and store it with care to pre-
vent accidental activation. This could result in incorrect ECG inter
pretation. Also, switch off the device before shipping to prevent inad-
vertent data transmission.
CAUTION
Repairs must be carried out only by persons authorized by GETEMED.
If you find or even suspect a malfunction, send the device for testing to
GETEMED or a facility authorized by GETEMED. Please add a detailed
description of the observed malfunction.
3.5 Cleaning the Device and Accessories
Observe the following guidelines when cleaning the device and ac-
cessories:
Switch off the device before cleaning/disinfection.
Disinfect the device and the charging pad at regular intervals,
prior to first use, and before passing it on to another person.
Clean the device and the charging pad before performing surface
disinfection.

Safety and Reliability
77811011 PhysioMem® PM 100 2G 17
Use a lint-free cloth slightly moistened with water or a mild soap
solution to externally clean the device, the Wireless Charging
Transmitter Pad and the carrying pouch.
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 circumstances.
Wash the storage pouch by hand at 30 °C (86°F). Do not machine
wash or dry the carrying pouch.
Use cleaning and disinfection agents only in accordance with the
manufacturer’s instructions. Make sure to use the correct dilution
factor.
GETEMED recommends disinfecting the device with a 70% alcohol
solution.
CAUTION
Do not use solvents such as ether, acetone, or petroleum ether;
such substances can damage plastic parts.
CAUTION
Do not sterilize the device or accessories.
3.6 Disposing of the Device, Batteries, and Accessories
Electrical devices and accessories contain metal and plastic parts.
To avoid any adverse environmental impact, dispose of the device
and its accessories in accordance with applicable waste regulations.
If you have questions concerning the disposal of this product, con-
tact GETEMED or its representatives.

Safety and Reliability
18 PhysioMem® PM 100 2G 77811011
CAUTION
The symbol with the waste bin reminds you not to dispose of devices
that contain batteries together with normal waste. As the end user,
you are required to dispose of any batteries in accordance with local
and national regulations.
3.7 Established Medical Practices
Instructions listed in this manual IN NO WAY supersede established
medical practices concerning patient care. Under all circumstances,
proceed according to established medical practices.
3.8 Manufacturer Responsibility
The manufacturer is responsible for safety, reliability, and perfor-
mance only if the following conditions are met:
Assembly operations, extensions, readjustments, modifications,
or repairs are carried out by persons authorized by GETEMED.
The device is used and stored in accordance with the information
given in this manual.

Control Elements, Putting into Operation
77811011 PhysioMem® PM 100 2G 19
4Control Elements, Putting into Operation
4.1 Control Elements
1
2
Fig. 3. Button and display
1Button for switching on and off and for starting a recording
2Display for the indication of operating modes and error codes
The four electrodes for the ECG lead are positioned on the back (Fig. 4)
of the device.

Control Elements, Putting into Operation
20 PhysioMem® PM 100 2G 77811011
Fig. 4. Back of the recorder with electrodes
4.2 Putting into Operation, Fully Charging the Battery
NOTE
If the ambient temperature is lower than 0 °C, the device should not
be charged.
The device has a built-in rechargeable battery, which is charged by
inductive coupling with the Wireless Charging Transmitter Pad
(charging pad).
Before first use of the device, the battery has to be fully charged.
Use the USB cable to connect the included charging pad (Fig. 5) to
the power supply plug and connect this to the mains supply. Then
place the device on the charging pad.