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INSTRUCTION MANUAL

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Содержание BIA 101 BIVA PRO

Страница 1: ...INSTRUCTION MANUAL...

Страница 2: ......

Страница 3: ...Rev 0 03 2019 Page 3 to 36 BIA101BIVA Read this instruction manual carefully and keep it on hand for future consultation Document code HB BVA 01 ENG Revision Status rev 0 of 03 2019...

Страница 4: ...PLIED PARTS 10 CHAPTER 2 PERFORMING A TEST 11 2 1 SWITCHING THE DEVICE ON AND OFF 11 2 2 TETRAPOLAR PATIENT LEAD 11 2 3 ELECTRODES 12 2 4 ELECTRODE PLACEMENT 12 2 4 1 Positioning of the subject 13 2 5...

Страница 5: ...IONS 27 5 2 TROUBLESHOOTING 27 5 2 1 If measurements are inaccurate or unintelligible 28 5 2 2 If the device will not switch on 28 5 2 3 If the device does not display results during measurement 28 5...

Страница 6: ...es that the device used in accordance with the aforesaid conditions and within the limits set out in the Safety Warnings section point 1 7 SAFETY WARNINGS has been designed and manufactured to have no...

Страница 7: ...between Resistance and Reactance Value in degrees SYMBOLS Symbol referring to the manual Icon of Bluetooth used for wireless communication between the BIA101BIVA and the selected device Symbol indicat...

Страница 8: ...other medical and or electronic equipment belonging to the same certification class Do not use the device in the presence of flammable gases anaesthetic gases and any gaseous mixture containing oxyge...

Страница 9: ...by unskilled staff Maintenance and repair must only be performed by qualified technical personnel All tampering by unauthorised staff causes expiry of the warranty and the certification This could da...

Страница 10: ...366 Application of usability engineering to medical devices Risk analysis and management EN ISO 14971 Directive 2001 65 EC RoHS 2 IEC 62304 Medical device software CLASSIFICATION OF THE DEVICE 1 9 BIA...

Страница 11: ...the device is disconnected from the patient and not used for over 15 seconds the auto off system is triggered to conserve the battery charge TETRAPOLAR PATIENT LEAD 2 2 The patient cable is fitted wit...

Страница 12: ...l performance characteristics generating incorrect measurements with poor repeatability and in the worst cases leading to incorrect interpretation ELECTRODE PLACEMENT 2 4 High repeatability with a low...

Страница 13: ...nce measurement There is no need to empty the bladder since third space fluids are not analysed If the test is performed within two hours after meals the measurement is not influenced by digestive pro...

Страница 14: ...minimise all the factors which may cause a non tissue related weight variation PERFORMING A TEST 2 6 Position the patient as shown lying face upwards on a non conductive surface i e wooden couch padd...

Страница 15: ...Rev 0 03 2019 Page 15 to 36 BIA101BIVA Selftest Check 1 battery Check 2 internal function test Check 3 sensor calibration test performed at every switch on...

Страница 16: ...dry or humid electric measurements are altered Attempt to normalise the skin s condition In children keep a distance of 5 cm between the injection scanning pair if necessary proximally moving sensors...

Страница 17: ...logical con ditions for over 30 years The BIA101BIVA device emits a weak current well below the 500 microamp threshold recognised as critical for risks of interaction with other active medical devices...

Страница 18: ...vided can be installed by simply connecting it to a USB 2 0 or 3 0 port The Bodygram Plus software must not be running The Internet connection must be active to enable installation of the correct driv...

Страница 19: ...look for the previously paired BIA101 BIVA device by default Data transfer procedure 3 4 Start Bodygram Plus Perform a BIA analysis following the standard protocol If the analysis is correct this scr...

Страница 20: ...wn automatically to conserve battery charge Troubleshooting 3 5 Before activating a service request users are advised to follow these simple instructions If more than one Bluetooth device is installed...

Страница 21: ...echarged exclusively using the supplied battery charger which is certified in compliance with IEC 60601 1 2005 The use of battery chargers not authorised by the producer leads to loss of warranty cove...

Страница 22: ...nect the battery charger to the device by means of the connector marked SENSOR CHARGE located in the centre of the rear of the device Complete charging takes about 6 hours a battery recharge control c...

Страница 23: ...clips if they are oxidized or cannot be connected to the electrodes correctly Electrodes check that the electrodes are approved by the manufacturer with low impedance and certified for BIA analyses c...

Страница 24: ...ce if the device continues to show the error CALIBRATION AND TESTING 4 4 Only qualified personnel are authorised to perform calibration using precision instrumentation in compliance with procedures de...

Страница 25: ...ed tolerances Tester circuit tolerances 4 4 2 It is perfectly normal to see a few ohms deviation with respect to nominal values If the Resistance Rz and Reactance Xc vary by more than 3 and 10 respect...

Страница 26: ...y interfere with the measurement No routine cleaning is necessary The device s cleanliness should be inspected once a month The device and its accessories do not require sterilisation Not suitable for...

Страница 27: ...ice at the time of purchase The warranty does not cover Normal wear and tear Accidental damage to the device or its accessories Damage to third parties resulting from careless or improper use of the d...

Страница 28: ...ce will not switch on 5 2 2 Put the device on charge for at least 1 hour If the device has not been used for a long time it may be necessary to recharge the battery even if the auto discharge of the t...

Страница 29: ...h care facility RMA Return Material Authorization PROCEDURES 5 4 Go to www akern com Tech Support and download the repair form MOD 28 Compile the form in full and send it with the device Make sure you...

Страница 30: ...idents or near misses This procedure requires users to report all incidents or near misses occurring during use of the device to Akern The user has access to a link managed by the Italian Health Minis...

Страница 31: ...eactance values are expressed in A bioimpedance analyser measures Resistance and Reactance and calculates the constituent parts of body composition by means of predictive algorithms The electrical mod...

Страница 32: ...components are Sensor circuit board Display Digital UI circuit board Battery 7 4V 2600 mAh Power supply control circuit board DB 9 pin multipole connector Bluetooth Module Class 2 1 EDR Detailed diagr...

Страница 33: ...ATTERY CHARGE AUTONOMY About 16 hours MEASUREMENT OUTPUT SIGNAL Signal type DC 0 sinusoidal signal Current output rms 250 A RMS 50 kHz 1 MEASUREMENT FREQUENCY 50 kHz 1 CLASSIFICATION under Directive 9...

Страница 34: ...Directive 93 42 EEC as amended for Medical Devices Class II type A is obtai ned by means of a product certification procedure in accordance with annex II and the device is manufactured in accordance...

Страница 35: ...nt cable 1 Biatrodes electrodes 100 pcs 1 USB Bluetooth accessory 1 Electronic testing circuit tester 1 4 spare alligator clips 1 Protection case 1 Device instruction manual 1 Software user manual 1 I...

Страница 36: ...2 34 50065 Pontassieve Florence Italy Tel 39 0558315658 FAX 39 0558323516 akern akern com All rights reserved No part of this document may be photocopied reproduced or translated into other languages...

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