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