getemed PhysioMem PM 1002G User manual

Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring
Operating Manual
Instructions d'utilisation
PhysioMem®PM 100 2G
Tele-ECG Event Recorder
Télé-enregistreur d'événements ECG

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Content
1Intended Use, Indications and Mode of Operation.................................... 5
1.1 Intended Use....................................................................................... 5
1.2 Indications........................................................................................... 5
1.3 Mode of Operation .............................................................................. 6
2CE Compliance, Device Labels and Packaging Label .............................. 7
2.1 CE 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.............................................................................. 13
3.4 Safety and Reliability Only with Proper Maintenance..................... 15
3.5 Cleaning the Recorder and Accessories......................................... 16
3.6 Disposing of the Device, Batteries, and Accessories ..................... 17
3.7 Established Medical Practices ........................................................ 17
3.8 Manufacturer Responsibility............................................................ 17
4Control Elements, Putting into Operation............................................... 18
4.1 Control Elements ............................................................................. 18
4.2 Putting into Operation, Fully Charging the Battery ........................ 19
5Recording and sending an ECG ............................................................... 24
5.1 How and where you apply the device............................................... 24
5.2 Recording an ECG ............................................................................ 25
5.3 Sending an ECG Recording.............................................................. 27
5.4 Switching off the Device................................................................... 29
6The System of PhysioMem and ReSTA.................................................... 30
6.1 Overview............................................................................................ 30
6.2 ECG Report ....................................................................................... 31
7Meaning of Display Symbols and Audible Notifications ......................... 34
7.1 Display Symbols ............................................................................... 34
7.2 Audible Notifications ........................................................................ 36

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8Troubleshooting........................................................................................ 37
8.1 Symptom, Cause, and Recommendation ......................................... 37
8.2 Error Codes Displayed...................................................................... 38
9Accessories, Ordering Information.......................................................... 39
10 Specifications............................................................................................ 40
10.1 Classification..................................................................................... 40
10.2 General.............................................................................................. 40
10.3 ECG and Heart Rate.......................................................................... 40
10.4 Data Transfer.................................................................................... 41
10.5 Operation Conditions........................................................................ 41
10.6 Storage and Transport Conditions................................................... 41
10.7 Charging Pad .................................................................................... 41
10.8 Scope of Delivery .............................................................................. 42
10.9 EMC Specifications according to IEC 60601-1-2............................. 42
10.9.1 General Specifications, Table 201................................ 42
10.9.2 General Specifications, Table 202................................ 43
10.9.3 Non Life-Sustaining Systems, Table 204 .................... 45
10.9.4 Recommended Separation Distances, Table 206 ....... 47

Intended Use, Indications and Mode of Operation
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1Intended Use, Indications and Mode of
Operation
These operating instructions are intended for medical doctors and
medical personnel.
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 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 evalua-
tion of recurrent unexplained episodes of racing heart, syncope, pal-
pitations 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
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where the nature of variations is such that it could result in immedi-
ate danger to the patient.
The device is not indicated for patients with an implanted cardiac
pacemaker or ICD.
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 PhysioMem PM 100 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.

CE Compliance, Device Labels and Packaging Label
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2CE Compliance, Device Labels and
Packaging Label
The following section explains the symbols used with the recorder.
2.1 CE Compliance
The CE Mark and Notified Body Registration Number signifies the
device has met all essential requirements of European Medical
Device Directive 93/42/EEC.
The CE Mark signifies the device meets all essential requirements of
the Radio Equipment Directive 2014/53/EU.

CE Compliance, Device Labels and Packaging Label
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2.2 Product and Package Information
The labels show the name and address of the manufacturer along
with the product and model identification.
Fig. 1. Device label of the recorder
Fig. 2. Device label of the charging pad

CE Compliance, Device Labels and Packaging Label
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The symbols have the following meanings:
Observe the information in the operating
manual for proper use of the device.
Follow Instructions for Use. Read and under-
stand the operator's manual before using the
device or product.
REF (reference) number to identify and order
the product.
Serial number
The heart symbol informs clinicians that the de-
vice 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
4 = protected against splashing water
IP21 The ingress protection classification of the
charging pad is IP21, whereby
2 = protected against objects > 12.5 mm
1 = protected against dripping water
The symbol indicates that the device has an
integrated lithium polymer LiPo rechargeable
battery.
This symbol indicates that you must dispose
of the device properly. Further information is
provided in the section “Disposing of the De-
vice, Batteries, and Accessories” on page 17.

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Below the solid factory symbol is the year in
which the device was manufactured.
Next to the solid factory symbol is the name
of the manufacturer.
Non-ionizing electromagnetic radiation
2.3 Additional Symbols on the Packaging Label
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
Handle with care., fragile