Bedfont LungLife User Manual Download Page 1 | Manualshive

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Summary of Contents for LungLife

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Page 2: ...rforming the Test 6 Reviewing the Last Session Test Results 7 Care and Cleaning Of The LungLife 8 Table of Materials Used and Cleaning Disinfection Methods 8 Consumables Accessories and Spare Parts 9 Explanation of Symbols 9 Technical Specifications 10 Warranty 10 Regulatory Notices for the LungLife 11 CE Notice 11 FDA Notice 11 Declaration of Conformity 12 Appendix 13 ...

Page 3: ...k the mouthpiece with the tongue or teeth A spitting action or coughing will give false readings If used at home symptoms must take precedence over device measurements If the device is used for longer than its specified life the accuracy of the device may deteriorate Before use ensure that the batteries do not exceed their shelf life as indicated on the batteries Store in a clean dry place If you ...

Page 4: ... Main Components of the LungLife A Flowhead B On off button C Display D User buttons A B C D ...

Page 5: ...e by pressing the or button and releasing when the age is reached The values will increase decrease in values of 1 If the button is kept depressed the values will scroll faster Press the button to set the age 3 The height can now be set This is done by pressing the or button and releasing when the height is reached The values will increase decrease in values of 1 If the button is kept depressed th...

Page 6: ...eal blast the air out keep going keep blowing f Well done Now we need to do that three times Rest for a while until you are ready to blow again 4 To view the final result the best values in the session press the button The Obstructive Index OI shows on the left hand arrow i Green is normal ii Yellow amber or red are not normal and the patient should be referred for spirometry 5 Following each blow...

Page 7: ... test session follow these steps 1 Turn the device on 2 When the device is ready for age entry press the button for approximately 3 seconds The last test session best results data will now show again 3 When you have finished reviewing the data press the OFF button for 3 seconds OR 4 Press The device will return to the age entry screen ready for entering the next test subject s data ...

Page 8: ...ith information to allow the assessment of other suitable cleaning and disinfecting procedures available in their facility All external parts of the LungLife require cleaning i e the removal of visible particulate contamina tion Do not attempt to insert any object or to clean the rotor or stator in the measuring system This device is not designated as a sterile device Wiping with a 70 Isopropyl Al...

Page 9: ...to separate collection at the product end of life Do not dispose of these products as unsorted municipal waste Attention reference relevant section in manual User Interface Symbols Battery status Full Battery status Half Battery status Empty flashing Blow Now Symbol Bad Test Symbol slow start or cough Lung Age Symbol Age Symbol Height Symbol Gender Symbol Population Group Symbol ...

Page 10: ...ph copd 6 Bedfont LungLife is guaranteed for one year Replace if it is faulty otherwise replace the unit every three years Excepting accidental transit damage or inappropriate use of the device Vitalograph Ltd Maids Moreton Buckingham MK18 1SW England Tel 44 0 1280 827110 Fax 44 0 1280 823302 Email sales vitalograph co uk www vitalograph co uk Vitalograph Inc 13310 West 99th Street Lenexa Kansas 6...

Page 11: ...tablishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes The device is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic ma...

Page 12: ...he 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 Directive 89 336 EC conformance demonstrated by following standard EN60601 1 2 2001 Equipment classification Residential Canadian Medical Device Regulation CMDR FDA Quality System Regulation QSR 21 CFR 820 EN ISO 13485 2003 Medical device...

Page 13: ...rding to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5GHz d 2 3 P 0 01 0 1 1 10 100 For transmitters rated at a 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 output power rating of the transmitter in watt...

Page 14: ...ited reserve the right to change or update this literature without prior notice Bedfont Scientific Ltd Registered office England and Wales Registered No 1289798 ISO 9001 2000 Cert No FM 31664 ISO 13485 2003 Cert No MD 502905 ...

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