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
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 Cardiac Diagnostics, Vital Signs Monitoring Telemonitoring...

  • Page 3: Table Of Contents

    Content Intended Use, Indications and Mode of 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 Product and Package Information ............ 8 2.3 Additional 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 Mode Of Operation

    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.

  • Page 6: Mode Of Operation

    Intended Use, Indications and Mode of Operation where the nature of variations is such that it could result in immedi- ate danger to the patient. 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

    Regulatory Compliance and Labeling 2 Regulatory Compliance and Labeling This section explains the symbols used in conjunction with the re- corder. 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.

  • Page 8: Product And Package Information

    Regulatory Compliance and Labeling 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 PhysioMem PM 100 2G 77811011 ®...
  • Page 9 Regulatory Compliance and Labeling 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”...

  • Page 10: Additional Symbols On The Packaging Label

    Regulatory Compliance and Labeling 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- Federal Communications Commission Identifica- PM100 tion Additional Symbols on the Packaging Label...

  • Page 11: Safety And Reliability

    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 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.

  • Page 12: General Warnings

    Safety and Reliability 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 13 Safety and Reliability 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 –...

  • Page 14: General Cautions

    Safety and Reliability 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.

  • Page 15: Safety And Reliability Only With Proper Maintenance

    Safety and Reliability 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.

  • Page 16: Cleaning The Device And Accessories

    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: Disposing Of The Device, Batteries, And Accessories

    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;...

  • Page 18: Established Medical Practices

    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.

  • Page 19: Control Elements, Putting Into Operation

    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.

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

    Control Elements, Putting into Operation 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 inductive coupling with the Wireless Charging Transmitter Pad (charging pad).
  • Page 21 Control Elements, Putting into Operation Fig. 5. PhysioMem on the charging pad To position the device properly, use the indentations on the charging pad and place the recorder's electrodes into these indentations. After the device has been switched on, the display of the device 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...
  • Page 22 In this case, disconnect the charging pad from the power supply and reconnect it. If the orange LED continues to flash, inform the service of GETEMED. PhysioMem PM 100 2G 77811011...
  • Page 23 Control Elements, Putting into Operation NOTE Even during charging, you can take the device from the charging pad and use it for a recording. NOTE If you put the device 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 Control Elements, Putting into Operation 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

    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 device. 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

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

  • Page 28: Sending An Ecg Recording

    Recording and sending an ECG Sending an ECG Recording NOTE The device uses public telecommunication networks to transmit data. Interruptions 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 (Fig.
  • Page 29 Recording and sending an ECG Step sequence of the display during transmission: A – ECG in storage – mobile transmission switched off B – ECG in storage – no mobile network C – ECG in storage – connection to mobile network established D –...

  • Page 30: Switching Off The Device

    Recording and sending an ECG NOTE The transmission process cannot be repeated manually. 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 seconds and hold it until the device switches off and the display goes blank.

  • Page 31: The System Of Physiomem And Resta

    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. Path of data transfer (1) Patient (2) Measurement (3) Transmission (4) Email (5) Physician/Hospital (6) Analysis ReSTA receives the data sent by the PhysioMem PM 100 via a mobile...

  • Page 32: Ecg Report

    The System of PhysioMem and ReSTA 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 System of PhysioMem and ReSTA The heart rate in beats per minute [bpm] is continuously calculated from the time that elapses between two consecutive beats. Averag- ing is not used for the calculation. The device is not indicated to de- tect Pauses automatically.
  • Page 34 The System of PhysioMem and ReSTA 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 explained 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...

  • Page 35: Meaning Of Display Symbols And Audible Notifications

    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 to 100 %), connected Powering up Recording in progress (25, 50, 75, 100 %)
  • Page 36 Meaning of Display Symbols and Audible Notifications Condition Symbol Transmission in progress (25, 50, 75, 100 %) continuous Recording disturbed and deleted automatically. No data transmitted. Condition Capacity Symbol Charging of the 0 to 10 % battery required Capacity display 20, 40, 60, 80, 100 % Charging Sequence in 20 % steps Ca-...

  • Page 37: Audible Notifications

    Meaning of Display Symbols and 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...

  • Page 38: Troubleshooting

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

  • 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

    Accessories, Ordering Information 9 Accessories, Ordering Information Product Number 1 PhysioMem PM 100 2G Tele ECG Event Recorder 77212001 2 Wireless Charging Transmitter Pad 77442301 3 Power supply for wireless charging transmitter pad 77441101 4 USB cable for wireless charging transmitter pad...

  • Page 41: Specifications

    Specifications 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 rechargea- Charging method ....

  • Page 42: Data Transfer

    Specifications Analog resolution ....3 µV Open lead detection... Yes 10.4 Data Transfer Transmission technology.. GSM Quad band module RF frequency range ... 850/900/1800/1900 MHz Max. RF power transmitted … ....2W / 33dBm SAR value......1.95 W/kg 10.5 Operation Conditions Temperature......

  • Page 43: Scope Of Delivery

    Specifications Ingress protection ..... IP21 Operation Frequency ..109.39kHz - 174.3kHz Max. RF power transmitted -8.12dBμA/m @10m 10.8 Scope of Delivery PhysioMem PM 100 2G, Wireless Charging Transmitter Pad, power ® supply and USB cable, neck lanyard, operating manual, patient’s guide, storage pouch.

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

    Specifications 10.9.2 Guidance and manufacturer’s declaration – electromagnetic immunity (line-bound disturbances) The device is intended for use in the electromagnetic environment specified below. The customer or the user should ensure that the device is used in such an environment. Immunity test IEC 60601 test level* Compliance level* Electromagnetic envi- ronment –...
  • Page 45 Specifications Power fre- 30 A/m 30 A/m Power frequency mag- quency netic fields should be at levels characteristic of a (50/60 Hz) typical location in a typi- magnetic field cal commercial or hospi- IEC 61000-4-8 tal environment. NOTE: U is the AC mains voltage prior to application of the test level. 77811011 PhysioMem PM 100 2G...

  • Page 46: Electromagnetic Immunity

    Specifications 10.9.3 Guidance and manufacturer’s declaration - electromagnetic immunity (Conducted and radiated RF disturbances) The device is intended for use in the electromagnetic environment specified below. The customer or the user should ensure that the device is used in such an environ- ment.
  • Page 47 Specifications **) IEC 60601-1-2: 2015, Table 9: Test Band a) Service a) Modulation b) Max. Dis- fre- (MHz) power tance munity quency test (MHz) level (V/m) 380 –390 TETRA 400 Pulse modula- tion b) 18 Hz 430 – GMRS 460, FRS FM c) ±...
  • Page 48 Specifications NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
  • Page 50 Distributor: Manufacturer: GETEMED Medizin- und Informationstechnik AG Oderstr. 77 / 14513 Teltow Phone: +49 3328 3942-0 Fax: +49 3328 3942-99 Revision F / 2020-05-11 info @ getemed.de / www.getemed.de...

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