getemed PhysioMem PM 100 2G Operating Manual
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getemed PhysioMem PM 100 2G Operating Manual

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

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Summary of Contents for getemed PhysioMem PM 100 2G

  • Page 1 Operating Manual ® PhysioMem PM 100 2G Tele ECG Event Recorder +++ DRAFT for type approval of wireless charging transmitter pad +++ Cardiac Diagnostics, Vital Signs Monitoring Telemonitoring...

  • Page 3: Table Of Contents

    Content Intended Use, Indications and Operation ............5 1.1 Intended Use ..................5 1.2 Indications ....................5 1.3 Mode of Operation ................. 6 Regulatory Compliance and Labeling .............. 7 2.1 Regulatory Compliance ................7 2.2 Information on the Device Labels ............9 2.3 Symbols on the Packaging Label ............
  • Page 4 Troubleshooting .................... 38 8.1 Symptom, Cause, and Recommendation ..........38 8.2 Error Codes Displayed ................39 Accessories, Ordering Information ..............40 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 ................

  • Page 5: Intended Use, Indications And Operation

    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.

  • Page 6: Mode Of Operation

    The device is not indicated for patients with an implanted cardiac pace- maker or ICD. 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.

  • Page 7: Regulatory Compliance And Labeling

    2 Regulatory Compliance and Labeling 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.
  • Page 8 - 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.

  • Page 9: Information On The Device Labels

    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 ® 77811011 PhysioMem PM 100 2G...
  • Page 10 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 The heart symbol informs clinicians that the device is classi- fied as “cardiac floating” (CF) and that it is NOT protected against defibrillation.

  • Page 11: Symbols On The Packaging Label

    Federal Communications Commission Identification FCC ID 2AOPN-PM100 Observe instructions for use 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...

  • Page 12: Safety And Reliability

    3 Safety and Reliability 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.

  • Page 13: General Warnings

    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.

  • Page 14: General Cautions

    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 –...
  • Page 15 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.

  • Page 16: Safety And Reliability Only With Proper Maintenance

    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.

  • Page 17: Cleaning The Recorder And Accessories

    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.

  • Page 18: Disposing Of The Device, Batteries, And Accessories

    ▪ 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.

  • Page 19: Control Elements, Putting Into Operation

    4 Control Elements, Putting into Operation Control Elements Fig. 3. Button and display 1 Button for switching on and off and for starting a recording 2 Display 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.

  • Page 20: Putting Into Operation, Fully Charging The Battery

    Fig. 4. Back of the recorder with electrodes 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.
  • Page 21 Fig. 5. PhysioMem on the charging pad To position the PhysioMem properly, use the indentations on the charging pad and place the recorder's electrodes into these indenta- tions. After the PhysioMem has been switched on, the display of the PhysioMem and an LED on the charging pad show that the battery is being charged (see the table in section 7.1, page 35) The green LED is lit as soon as the charging pad is connected to the power supply system.
  • Page 22 If the orange LED flashes after the PhysioMem has been placed on the charging pad, an error with the charging process has occurred. In this case, disconnect the charging pad from the power supply and reconnect If the orange LED continues to flash, inform the service of GETEMED. ® PhysioMem...
  • Page 23 NOTE Even during charging, you can take the device from the charging pad and use it for a recording. NOTE If you put the PhysioMem on the charging pad while the battery has al- ready been fully charged to 100 %, the double beep does not sound and the orange LED is not lit.
  • Page 24 NOTE If the battery power is too low for using the device, this is indicated in the display (Fig. 11) when a recording is started. Fig. 11. Indication of insufficient battery power ® PhysioMem PM 100 2G 77811011...

  • Page 25: Recording And Sending An Ecg

    5 Recording and sending an ECG How and where you apply the device Fig. 12. Recorder on the patient’s chest The ECG electrodes are integrated like little feet in the back of the PhysioMem. To record an ECG, put the device directly on your chest. The correct position of the device is mid sternum (Fig.

  • Page 26: Recording An Ecg

    Fig. 13. How to adjust the neck lanyard Recording an ECG During recording, hold the device steady and press the four elec- trodes firmly on the chest (Fig. 14). Then press the button (1) to start the recording. Fig. 14. How to press the start button The recording duration is 40 seconds.
  • Page 27 NOTE An irregular beep during recording does not necessarily indicate a cardiac arrhythmia. In most cases, a technical error has occurred during the re- cording (artefacts). NOTE When the beep fails during recording correct the position of the de- vice and press it more firmly on the chest.

  • Page 28: Sending An Ecg Recording

    Sending an ECG Recording NOTE The device uses public telecommunication networks to transmit data. In- terruptions are possible depending on the network coverage, availability of the services and line quality. Therefore, it cannot be guaranteed that the transmission is always successful. After recording, the device automatically switches to sending mode and in the display, the number of recordings not yet sent is shown together with a progress indication:...
  • Page 29 C – ECG in storage – connection to mobile network established D – ECG in storage – connection to ReSTA established E – ECG sent – connection to ReSTA / status message After sending, the main display is shown again. Each ECG recording successfully sent is then deleted from the stor- age.

  • Page 30: Switching Off The Device

    NOTE You can start a new recording anytime during transmission. In this case, the transmission is interrupted. The ECG recording stays stored until the next transmission. Switching off the Device To switch off the device, press the button (1) for longer than 10 sec- onds and hold it until the device switches off and the display goes blank.

  • Page 31: The System Of Physiomem And Resta

    6 The System of PhysioMem and ReSTA Overview ReSTA is a server-based software for receiving and transmitting vital signs data (ECG). Fig. 18. Weg der Datenübertragung (1) Patient (2) Measurement (3) Transmission (4) Email (5) Physician/Hospital (6) Analysis ReSTA receives the data sent by PhysioMem via a mobile network, con- verts these data to a defined data format and redirects them via a mobile network to a defined target address.

  • Page 32: Ecg Report

    CAUTION The attending physician as receiver of an ECG has to ensure that these ECG data are assigned correctly to a patient. During the entire transmission process, no patient-related data are used. It is in a medical facility that the ECG recording is assigned to a patient by healthcare professionals.
  • Page 33 The heart rate in beats per minute [bpm] is continuously calculated from the time that elapses between two consecutive beats. Averaging is not used for the calculation.The device is not indicated to detect Pauses auto- matically. Fig. 19. ECG report NOTE The recording and transmission times refer to Central European Time or Central European Summer Time.
  • Page 34 NOTE Use the storage pouch supplied for safe storing of the device when not in use. NOTE Switch off the device if this is not to be used for some time. Proceed as ex- plained in the “Switching off the Device” section on page 30. NOTE Check the charging state of the device if it has not been used for some time and charge the device as explained in the “Putting into Operation,...

  • Page 35: Meaning Of Display Symbols And Audible Notifications

    7 Meaning of Display Symbols and Audible Notifications Display Symbols Condition Symbol Mobile transmission switched off No mobile network connection Mobile network found (0 to100 %), not connected Mobile network found (0 to100 %), connected Powering up Recording in progress (25, 50, 75, 100 %) Transmission in progress (25, 50, 75, 100 %)
  • Page 36 Condition Symbol Recording disturbed and deleted automatically. No data transmitted. Condition Capacity Symbol Charging of the bat- 0 to 10 % tery required Capacity display 20, 40, 60, 80, 100 % Charging Sequence in 20 % steps Capac- En continu ity charged is shown as solid block.

  • Page 37: Audible Notifications

    Audible Notifications Condition State Comment Signal Success Process has been Rising sequence of 4 short finished success- beeps fully. Confirmation REC, Process has been 1 long beep BOOT started success- fully. Error Storage full 3 short beeps (low frequency) Recording in 1 short beep activated by every process heart beat until recording has...

  • Page 38: Troubleshooting

    Fehler! Verweisquelle konnte nicht gefunden werden. 8 Troubleshooting This section gives troubleshooting recommendations and explains error codes. Symptom, Cause, and Recommendation Symptom Cause Recommendations Battery cannot Charging pad not con- Connect USB cable to charg- be charged. nected to mains supply. ing pad and mains supply.

  • Page 39: Error Codes Displayed

    Error Codes Displayed E01-E05 If the display shows the GETEMED icon and one of the error codes E01 to E05, a system error has occurred in the recorder. In this case, contact the manufacturer's service or send the device to the manu- facturer.

  • Page 40: Accessories, Ordering Information

    Fehler! Verweisquelle konnte nicht gefunden werden. 9 Accessories, Ordering Information Product REF Number 1 PhysioMem PM 100 2G 77212001 Tele ECG Event Recorder 2 Charging pad 77442301 3 Power supply FW7713/EU for charging pad 77441101 4 USB cable for charging pad...

  • Page 41: Specifications

    Fehler! Verweisquelle konnte nicht gefunden werden. 10 Specifications 10.1 Classification Product class ......IIa according to MDD 93 / 42 / EEC 10.2 General Dimensions ......114 mm x 68 mm x 15 mm Weight ......... approx. 100 g Battery type ......integrated Lithium polymer rechargeable Charging method ....

  • Page 42: Data Transfer

    Fehler! Verweisquelle konnte nicht gefunden werden. Open lead detection... .. Yes 10.4 Data Transfer Transmission technology..GSM Quad band module RF frequency range ....850/900/1800/1900 MHz SAR value......1.95 W/kg 10.5 Operation Conditions Temperature......5 to 45 °C Relative humidity ....

  • Page 43: Scope Of Delivery

    Fehler! Verweisquelle konnte nicht gefunden werden. 10.8 Scope of Delivery ® PhysioMem PM 100 2G, charging pad, power supply and USB cable, neck lanyard, operating manual, patients’s guide, storage pouch. 10.9 EMC Specifications 10.9.1 General Specifications Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below.

  • Page 44: Electromagnetic Immunity (Line-Bound Disturbances)

    Fehler! Verweisquelle konnte nicht gefunden werden. 10.9.2 Electromagnetic immunity (line-bound disturbances) Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The cus- tomer or the user should ensure that the device is used in such an environment. Immunity test IEC 60601 test level Compliance level...

  • Page 45: Electromagnetic Immunity (Conducted And Radiated Rf Disturbances)

    Fehler! Verweisquelle konnte nicht gefunden werden. 10.9.3 Electromagnetic immunity (conducted and radiated RF disturbances) Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The cus- tomer or the user should ensure that the device is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 47 Distributor: Manufacturer: GETEMED Medizin- und Informationstechnik AG Oderstr. 77 / 14513 Teltow Phone: +49 3328 3942-0 Fax: +49 3328 3942-99 info @ getemed.de / www.getemed.de Revision DRAFT / 2018-09-07...

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