getemed PhysioMem PM 100 2G User manual

Cardiac Diagnostics,
Vital Signs Monitoring
Telemonitoring
Operating Manual
PhysioMem®PM 100 2G
Tele ECG Event Recorder
+++ DRAFT for type approval of wireless charging transmitter pad +++

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Content
1Intended Use, Indications and 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 Information on the Device Labels...........................................................9
2.3 Symbols on the Packaging Label ...........................................................11
3Safety and Reliability ....................................................................................12
3.1 Definitions............................................................................................12
3.2 General Warnings.................................................................................13
3.3 General Cautions..................................................................................14
3.4 Safety and Reliability Only with Proper Maintenance...........................16
3.5 Cleaning the Recorder and Accessories ................................................17
3.6 Disposing of the Device, Batteries, and Accessories .............................18
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

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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................................................................................43
10.9.1 General Specifications ......................................................43
10.9.2 Electromagnetic immunity (line-bound disturbances) ......44
10.9.3 Electromagnetic immunity (conducted and radiated RF
disturbances)....................................................................45
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
DRAFT
2018-09-07
Update for RED and FCC compliance

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1 Intended Use, Indications and 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 transmit-
ting multiple event recordings via cellular telephony net- works to a com-
patible 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 clini-
cal environments. Home environments include urban/suburban/ rural,
school/office/retail environments, and vehicles like trains and cars. Air-
planes 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 situ-
ations.
1.2 Indications
The PM 100 is indicated for the diagnostic evaluation of adult and pe- di-
atric (over 10 kg body weight) patients with asymptomatic and sympto-
matic disturbances of the cardiac rhythm and for the evalua- tion of recur-
rent unexplained episodes of racing heart, syncope, pal- pitations or dizzi-
ness.
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, where the na-
ture of variations is such that it could result in immedi- ate danger to the
patient.

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The device is not indicated for patients with an implanted cardiac pace-
maker 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.
A wireless charging transmitter pad is used to recharge the battery of the
PhysioMem PM 100.

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2 Regulatory Compliance and Labeling
2.1 Regulatory Compliance
The CE Mark and Notified Body Registration Number signifies the device
including accessories meets all essential requirements of the Medical De-
vice Directive 93/42/EEC.
The CE Mark signifies the device including accessories meets all essential
requirements of the Radio Equipment Directive 2014/53/EU.
This device including accessories complies with Part 18 of the FCC Rules.
CAUTION: Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
product.
NOTE: This equipment has been tested and found to comply with the lim-
its for a wireless power transfer, pursuant to Part 18 of the FCC Rules.
These limits are designed to provide reasonable protection against harm-
ful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to ra-
dio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be deter-
mined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.

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-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
RF Exposure Compliance
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment. This equipment should be installed and op-
erated with minimum distance 20cm between the radiator and your body.
This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.

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2.2 Information on the Device Labels
The symbols and content of the device labels is described below.
Fig. 1. Device label of the recorder
Fig. 2. Device label of the charging pad

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Observe the information in the operating manual for
proper use of the device.
Observe instructions for use
REF (reference) number to identify and order the prod-
uct.
Serial number
Theheart symbolinforms clinicians that thedeviceisclassi-
fied as “cardiac floating” (CF) and that it is NOT protected
againstdefibrillation.
IP64
The ingress protection classification of the PhysioMem
is IP64, whereby 6 = dustproof and 4 = protected
against splashing water
IP21
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 notified body
The symbol indicates that the device has an integrated
lithium polymer LiPo rechargeable battery.
This symbol indicates that you must dispose of the de-
vice properly. Further information is provided in the
section “Disposing of the Device, Batteries, and Acces-
sories”
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

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FCC ID 2AOPN-PM100
Federal Communications Commission Identification
Observe instructions for use
2.3 Symbols on the Packaging Label
The symbols and content of the packaging label is described below.
REF (reference) number to identify and order the
product.
Serial number
The upper and lower temperature limits allowed
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

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3 Safety 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 seriousness. Famil-
iarize 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 in-
formation or notes.

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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 possi-
ble 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 fol-
lowing 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 recorder and accessories after every use. For information
refer to the section 3.5, page 17.

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WARNING
NOT A MONITORING DEVICE –The PhysioMem PM 100 recorder is not a
monitoring device and is not intended for monitoring the clini- cal condi-
tion of a patient.
Do NOT use the PhysioMem as a monitoring device.
WARNING
EXPLOSION HAZARD –Electrical sparks can cause explosions in the pres-
ence 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, possi-
bly for job-related reasons.
WARNING
MALFUNCTION OF PACEMAKERS AND ICD –The PhysioMem PM 100 re-
corder has an integrated mobile transmission module. Active mobile
transmission devices in the close vicinity of pacemakers and implantable
cardioverters/defibrillators (ICD ) can cause malfunctioning of these de-
vices.
3.3 General Cautions
CAUTION
While acquiring data do not use mobile phones or other electrical devices
close to PM 100 that may cause interference, such as computers or elec-
trical tools.

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CAUTION
Switch off the device in locations where the use of mobile network de-
vices is totally or at times forbidden (e.g., intensive care unit, plane).
CAUTION
The temperature of the recorder 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. Then, the
correct functioning of the device can no longer be guaran- teed.
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.

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3.4 Safety and Reliability Only with Proper Maintenance
CAUTION
Proper maintenance is vital for long-term safety and reliability of the re-
corder. Each time before giving the recorder to a patient, visually check the
recorder for damage.
CAUTION
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 infection.
For hygienic reasons and especially to help protect our service personnel,
please disinfect the recorders 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 interpretation.
Also, switch off the device before shipping to prevent inadvertent 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.

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3.5 Cleaning the Recorder and Accessories
Observe the following guidelines when cleaning the recorder and accesso-
ries:
▪Switch off the device before cleaning/disinfection.
▪Disinfect the recorder and the charging pad at regular intervals, prior
to first use, and before passing it on to another person.
▪Clean the recorder and the charging pad before performing sur- face
disinfection.
▪Use a lint-free cloth slightly moistened with water or a mild soap solu-
tion to externally clean the recorder and carrying pouch.
CAUTION
Do not submerge the recorder or allow fluid to enter the recorder 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 manu-
facturers instructions. E 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 sub-
stances can damage the plastic of the device's housing.
CAUTION
Do not sterilize the recorder or accessories.

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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 accesso-
ries in accordance with applicable waste regulations.
If you have questions concerning the disposal of this product, con- tact
GETEMED or its representatives.
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 re-
quired 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 medi-
cal 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 performance
only if the following conditions are met:
▪Assembly operations, extensions, readjustments, modifications, or re-
pairs are carried out by persons authorized by GETEMED.
▪PhysioMem 100 is used and stored in accordance with the infor-
mation given in this manual.

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4 Control 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 recorder.

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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 induc-
tive coupling with the 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
PhysioMem on the charging pad.