getemed PhysioMem PM 100 2G Operating Manual Download Page 8 | Manualshive

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Regulatory Compliance and Labeling

8

PhysioMem

®

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

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Summary of Contents for PhysioMem PM 100 2G

Page 1: ...Cardiac Diagnostics Vital Signs Monitoring Telemonitoring Operating Manual PhysioMem PM 100 2G Tele ECG Event Recorder...

Page 2: ......

Page 3: ...ance 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 4 Control Elements P...

Page 4: ...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 disturbance...

Page 5: ...cles 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...

Page 6: ...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 re...

Page 7: ...ction 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 D...

Page 8: ...abeling 8 PhysioMem 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 Wirele...

Page 9: ...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 charg...

Page 10: ...tic 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 u...

Page 11: ...s 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...

Page 12: ...CK LANYARD Neck lanyards present a possible 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...

Page 13: ...to be in such an environment possibly for job related reasons WARNING MALFUNCTION OF PACEMAKERS AND ICD The device has an inte grated mobile transmission module Active mobile transmission de vices in...

Page 14: ...se mobile phones or other electrical equipment such as computers or electrical tools close to the device That may cause interference CAUTION Switch off the device in locations where the use of mobile...

Page 15: ...ECG data keep the device pro tected against unauthorized access by third persons CAUTION When wearing the device ensure that the electrodes do not contact other conductive parts including earth 3 4 Sa...

Page 16: ...n Also switch off the device before shipping to prevent inad vertent data transmission CAUTION Repairs must be carried out only by persons authorized by GETEMED If you find or even suspect a malfuncti...

Page 17: ...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...

Page 18: ...ructions listed in this manual IN NO WAY supersede established medical practices concerning patient care Under all circumstances proceed according to established medical practices 3 8 Manufacturer Res...

Page 19: ...nts Putting into Operation 4 1 Control Elements 1 2 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 co...

Page 20: ...n 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 Before first use of...

Page 21: ...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 p...

Page 22: ...ed on while it is on the charging pad If the battery of the device has been fully charged the orange LED goes out and only the green LED is lit Fig 8 Fig 8 Charging process completed NOTE If the orang...

Page 23: ...ing the battery after complete discharge takes approx 3 hours A fully charged battery lasts approx 5 days in typical use 3 ECG recordings per day Press the button 1 to switch on the device The progres...

Page 24: ...g into Operation 24 PhysioMem PM 100 2G 77811011 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 insu...

Page 25: ...is mid sternum Fig 12 Make sure that all four electrodes have skin contact and that there are no pieces of clothing or other items between electrode and skin The manufacturer recommends always wearing...

Page 26: ...g duration is 40 seconds During this time breathe steadily refrain from jerky body movements and avoid changing the device s position on the chest During recording every heart beat R R is accompanied...

Page 27: ...th strong chest hair shortly move the device back and forth so that no hair obstructs the contact between electrodes and skin NOTE Skin contact of the electrodes can be impaired when the skin is too d...

Page 28: ...ys 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 16 Fig 16 Send...

Page 29: ...e transmission of one or several ECG fails immediately after recording the transmission process is repeated automatically The device repeats the transmission at the following time intervals first repe...

Page 30: ...on is interrupted The ECG recording stays stored until the next transmission 5 4 Switching off the Device To switch off the device press the button 1 for longer than 10 seconds and hold it until the d...

Page 31: ...es the data sent by the PhysioMem PM 100 via a mobile network converts these data to a defined data format and redirects them via a mobile network to a defined target address In ReSTA the device numbe...

Page 32: ...n ECG recording is completed ReSTA sends a confirmation signal to the respective PhysioMem PM 100 and the ECG sent is deleted from the storage of the device 6 2 ECG Report The ECG report consists of t...

Page 33: ...ation The device is not indicated to de tect Pauses automatically Fig 19 ECG report NOTE The recording and transmission times refer to Central European Time or Central European Summer Time CET or CEST...

Page 34: ...ge 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 Fully Charging the Battery section on page 20 N...

Page 35: ...7 Meaning of Display Symbols and Audible Notifications 7 1 Display Symbols Condition Symbol Mobile transmission switched off No mobile network connection Mobile network found 0 to100 not connected Mo...

Page 36: ...ng disturbed and deleted automatically No data transmitted Condition Capacity Symbol Charging of the battery required 0 to 10 Capacity display 20 40 60 80 100 Charging Sequence in 20 steps Ca pacity c...

Page 37: ...nished success fully Rising sequence of 4 short beeps Confirmation REC BOOT Process has been started success fully 1 long beep Error REC Storage full 3 short beeps low frequency Recording in process R...

Page 38: ...ction 4 2 ECG data cannot be transmit ted No mobile network con nection Data transmission will be re peated automatically If nec essary change location Device has not been acti vated by the manufac tu...

Page 39: ...error code display E06 If the E06 error code is displayed contact the technical service E07 If the E07 error code is displayed you have to restart the device Press the button 1 for 10 seconds until t...

Page 40: ...ele 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 77412001 5...

Page 41: ...e Charging method Inductive coupling with charging pad Operating mode 40 second ECG recording followed by data transmission User interfaces Start button LC Display acoustic buzzer Material ABSplasticc...

Page 42: ...R value 1 95 W kg 10 5 Operation Conditions Temperature 5 to 45 C Relative humidity 10 to 95 non condensing Ambient pressure 106 to 50 kPa 106 to 80 kPa power supply 10 6 Storage and Transport Conditi...

Page 43: ...c environment specified below The customer or the user should ensure that the device is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11...

Page 44: ...ply lines 1 kV for input out put lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typi cal commercial or hospi tal environment Surges IEC 61000 4...

Page 45: ...50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency mag netic fields should be at levels characteristic of a typical location in a typi cal commercial or hospi tal environment NOTE UT...

Page 46: ...15 MHz and 80 MHz 10 V m 80 MHz to 2 7 GHz Immunity against wire less RF com munication de vices 3 V effective value 6 V effective value in the ISM bands accord ing to table 5 Note N 10 V m according...

Page 47: ...n 1 kHz Si nus 2 0 3 28 710 745 780 704 787 LTE Band 13 17 Pulse modula tion b 217 Hz 0 2 0 3 9 9 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modula tion b 18 Hz 2 0 3 28 1720 184...

Page 48: ...or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they...

Page 49: ......

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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