Vitalograph Model 4000 User Training Manual Download Page 17 | Manualshive

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11/16/2018

07560

file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html

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10. FDA NOTICE

Caution: Federal Law restricts this device to sale by, or on the order of a physician.

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Summary of Contents for Model 4000

Page 1: ...talograph 20lung 20monitor 20bt 20 20User 20Training 20Manual html 1 19 lung monitor BT Model 4000 User Training Manual Medical Devices Directive 93 42 EEC L169 Vol 36 EN ISO 13485 FDA QSR 21 CFR 820...

Page 2: ...sales vitalograph co uk www vitalograph eu Vitalograph GmbH Rellinger Stra e 64a 20257 Hamburg Germany Phone 040 54 73 91 0 Fax 040 547 391 40 e mail info vitalograph de www vitalograph de Vitalograph...

Page 3: ...PERFORMING THE TEST 4 REVIEWING PREVIOUS RESULTS 5 DELETING ALL RESULTS HISTORY 6 SENDING TEST RESULTS TO VITALOGRAPH REPORTS 5 CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR BT 1 HOME USE CLEANING...

Page 4: ...ver device measurements Before use ensure that the batteries do not exceed their shelf life as indicated on the batteries Store in a clean dry place If the patient at home thinks that the device is no...

Page 5: ...g the button and releasing when the value is reached Press the to roll back The values will increase decrease in values of 0 10 If the button is kept depressed the values will scroll faster 4 Press EN...

Page 6: ...ice unless the physician advises otherwise 2 Turn the device on with the mouthpiece inserted Use a disposable SafeTway mouthpiece in clinic 3 When the device is ready for a test holding the head high...

Page 7: ...istory entirely i e all previously stored session results follow these steps 1 Turn the device on 2 When the device is ready for a test press the and buttons simultaneously for approximately 10 second...

Page 8: ...commendation Disinfection Recommendation Plastic Mouthpieces ABS Wash in warm soapy water Rinse in clean water Cold liquid e g Effervescent Chlorine solution Body ABS Wipe with a damp cloth Alcohol wi...

Page 9: ...preceded by cleaning with an anti static foam cleaner if necessary Fascia PMMA PET Clean No Removable flowhead ABS Stainless Steel Clean No Disinfect by immersion in sodium dichloroisocyanurate solut...

Page 10: ...tion of free chlorine for 15 minutes Prepare disinfectant solution as directed in the manufacturer s guidelines Rinse with warm water for faster drying 4 Leave it to dry completely before reassembling...

Page 11: ...e x10 7 EXPLANATION OF SYMBOLS Type BF equipment Class II Attention reference relevant section in manual Manufacturer Year of Manufacture The device must be taken to separate collection at the product...

Page 12: ...IEC 61000 4 2 IEC 61000 4 3 battery operated Sensor Stator rotor Power Supply 2 x AAA batteries Operating Temperature 17 37 C Bad Test Criteria Slow start of test Vext 5 or a cough detected in the fir...

Page 13: ...e Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The 4000 Respiratory Monitor lung monitor uses RF energy only for its internal function Therefore its RF emissions are very low and...

Page 14: ...hould be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lin...

Page 15: ...m 80 MHz to 2 5 GHz Battery operated device 3V m from 80MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the 4000 Respiratory Monitor lung monitor...

Page 16: ...maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum outpu...

Page 17: ...7560 file C Users lcapamagian Downloads Vitalograph 20lung 20monitor 20bt 20 20User 20Training 20Manual html 17 19 10 FDA NOTICE Caution Federal Law restricts this device to sale by or on the order of...

Page 18: ...nex IX of MDD 93 42 EEC meets the following provisions of Annex II of the Medical Devices Directive as per Article 11 section 3a excluding point 4 of Annex II This device complies with the EMC Directi...

Page 19: ...ure can be recreated and the software has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warranted to be free of errors 4 This Guarantee doe...

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