User Manual
Contents
1. 1 CD Switch On Modify Green Zone 1 T Switch On er is a ft a Pi ts Pe A aY Upper Boundary N O 4 Ser Upper Boundary A wit IN Set PEF Personal Best a Na wo nt a a A r i e Set FEV1 Best A increase Fev O 4 Ser FEV Bast s w Note Zones ser at 0 and 50 Modify Other Zones 5 A or Y Lower Boundar Note 3 Zones now set Press lt lt to exit or for 4 7ones Q or mid Boundary Me 7 7 a Hm rt a i O aH Set Mid Boundary a Review History LL Switch On oT a F A er Q hold for 3 seconds Dr w a 3 A or Review History O 4H Return Default Zone Settings Q D Switch On V A hold for 10 fr a e k 13 Regulatory Notices for the Vitalograph asma 1 CE Notice Marking by the symbol C indicates compliance of the Vitalograph asma 1 to the Medical Devices Directive of the European Community Such marking is indicative that the Vitalograph asma 1 meets or exceeds the referenced technical standards The Vitalograph asma 1 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Vitalograph asma 1 is battery operated and is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply ne2. italograph ASMa 1 User Manual Model No 4000 Medical Devices Directive 93 42 EEC L169 Vol 36 EN ISO 13485 FDA QSR 21 CFR 820 803 Manufacturer Vitalograph Ireland Ltd Ennis Ireland Table Of Contents Warnings and AQYIsory NOICE S sais estes ha iat el 3 Main Components of the Vitalograph asman1eM oo cecccecececcececereceseesecerecerecreeseeeeeeerecereveneeseenrens 4 What Is The Vitalograph asma 1 Used For unssnenaesnennsennennnnnennnnnnennennennnnnnnnnennnnnnnn 4 What Is The Vitalograph asma 1 Used For unasennnaesnenneennennnnnnnnnnnnnnnnnnnennnnnnnennennnennennnn 5 The ASAMA SUNGICR ass sesnaakaelkknleiknlebknlnenlshelhuelan 5 How To Use The Vitalograph asma 1 acnnaaeenennannnnnnnnnnnennnnnnennnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnn 6 Setting Personal Best Reference Values 22202220220020002n0nnno anno nnn nn nano nnno nenn nnnnenenenenenn 6 seling Management Zono 2 2 un Di DIDI ee er Du 6 PORON NE T OS ee re REMIEWING FFEVIOUSRESUN Sana RER a eee et 8 Deleting All Results History cccccccccccnccccueseeccuccueneuccunnenccuesunsenecussencauesunsauecusseneausnsssauesusneneaaas 8 Care and Cleaning Of The Vitalograph asma 1 In Home Use ecccecccsseececerecerceeseesecereeseenrens 9 Cleaning and Disinfecting the Vitalograph asma 1 In Clinic Use nn nenn 9 Table of Materials Used amp Cleaning Disinfection Methods 022
3. 2022002200220 2er 10 Consumables Accessories and Spare Parts 2zu22022022uennennnnennnnnennnnne nennen nenne nennen nennen 11 E Dlana nonm Of SYMDOlS nee nee 11 Technical Specifications 0220022022002nennnnnnnnennennnnnnennnnnnennennnnnnennnnnnnnennnsenennennnnenennnenn 12 Warah Yens E ee E 12 APPENdICO S arran ae eee ea eee ee ee oes 13 TIC FeSO ee ee AN 13 Regulatory Notices for the Vitalograph asma 1 unaannannanennenanennnnnnnnnnnnnnnnnnnnnnnnneennnnnenn 14 GE INOW CC ee ee ee lese 14 FOA NOUCE ua ee 14 DEelarallon OF CORTOMINGY u ae rare 16 Copyright Vitalograph 2007 Print Ref No 07380 Current Edition Issue 2 Warnings and Advisory Notices Note Please read all the information in this manual before using the Vitalograph copd 6 A full set of instructions including cleaning instructions is available at www vitalograph co uk This Vitalograph device is intended to measure lung function for use in clinic with disposable mouthpieces or filters or for patient use at home under medical supervision Take care not to block the mouthpiece with the tongue or teeth A spitting action or coughing will give false readings lf 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 th
4. EEC and CMDR British Standards Institute BSI Certificate Nos CE 00772 MD 82182 FM 83550
5. Plan should be tailored to individual needs but will include basic facts about asthma roles of medication skills required for devices and medication environmental control measures when and how to take rescue actions The Asthma Sufferer Most people with asthma need to monitor their asthma at least twice a day and to have a plan of action to keep it under control Although how the sufferer feels and what the sufferer can do is important PEF or FEV1 scores may accurately show how the breathing is changing Modern asthma medicines aim to give the sufferer the best possible score keeping the sufferer in the green zone It is also important to aim for stable PEF FEV1 i e little difference between morning and evening scores and from day to day Many people over the ages of five will benefit from monitoring their asthma with the Vitalograph asma 1 indicating when and how much to use their reliever medication It will also help the doctor because scores make it easier to see how well the asthma is controlled and when treatment needs changing Only the doctor can determine the best Action Plan for the sufferer This is likely to be preceded by an initial assessment followed by a diagnostic phase The Vitalograph asma 1 records many test sessions for subsequent review by the healthcare professional The Action Plan is then assessed against the scores over several days The treatment and or Action Plan may be changed following the diagnostic phase T
6. e batteries Store in a clean dry place If you suspect that a defect has occurred you should check the Vitalograph copd 6 for operation and accuracy Main Components of the Vitalograph asma 1 A Flowhead B On off button C Display D User buttons What Is The Vitalograph asma 1 Used For The Vitalograph asma 1 is a medical device intended to give objective measures of lung function for help in managing asthma The device measures airflow out of the lungs when blown into as hard and fast as possible The Vitalograph asma 1 can reveal narrowing of the airways well in advance of an asthma attack being felt by the asthmatic Used mainly by persons with moderate to severe and persistent asthma the Vitalograph asma 1 can help determine e when to seek emergency medical care e the effectiveness of a person s asthma management and treatment plan e when to stop or add medication as directed by the physician e what triggers the asthma attack such as exercise induced asthma With asthma sometimes the sufferer may feel their breathing is fine but when the sufferer measures it with the Vitalograph asma 1 lung function may be decreased The Vitalograph asma 1 can help the sufferer determine airway changes and better manage the asthma The primary healthcare professional needs to educate the sufferer in Self Management of asthma This will start upon diagnosis and continue with all members of the healthcare team The Action
7. e history has been deleted it cannot be recovered To delete the history entirely i e all previously stored session results follow these steps 1 2 3 Turn the device on When the device is ready for a test G gt press and hold the and Y buttons for approximately 10 seconds A long beep will indicate success and the device will return to the test screen Care and Cleaning Of The Vitalograph asma 1 In Home Use The Vitalograph asma 1 should continue to give reliable measurements for up to three years in home use Then replace it with a new device The device should be kept clean and dust free Ifthe asthmatic suspects that the device is damaged or measuring incorrectly they should take it to their doctor who will be able to check its operation and accuracy The mouthpiece is the only part of the device which needs to be routinely cleaned in home use The outer surfaces should be thoroughly cleaned every week more often if necessary We recommend the use of an ordinary paying special attention to the mouthpiece area Cleaning and Disinfecting the Vitalograph asma 1 In Clinic Use A new mouthpiece either SafeTway or BVF should be used for each subject A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device It is recommended that the device be regularly cleaned according to the guidelines of the user s facility The disinf
8. ection materials and procedures applied in the users facility may be more appropriate than the methods outlined below In the event of visible contamination of the flowhead element it should be cleaned or disinfected as described in the accompanying table The device should be replaced in the event of damage or if visibly contaminated The frequency of cleaning and disinfecting is dependent on the facility s risk assessment usage and test environment but it should be at least monthly or every 100 subjects 300 blows It is recommended that the device be replaced annually or test and calibration serviced at least annually There is no planned preventive maintenance for this medical device Table of Materials Used amp Cleaning Disinfection Methods This listing of materials used is given to provide clinical users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device Cleaning Disinfection Recommendation Recommendation Plastic Wash in warm soapy Cold liquid e g Mouthpiece water Rinse in clean Effervescent Chlorine water solution Body PC ABS Wipe with a damp Alcohol wipe cloth IPA 70 90 cloth IPA 70 90 cloth IPA 70 90 SafeTway Cardboard ABS Dispose single use Dispose single use mouthpiece or BVF All external parts of the Vitalograph asma 1 require cleaning i e the removal of visible particulate contamination Do not at
9. er down time Warranty PC ABS Better than 3 FEV1 5 PEF Better than 0 15kPa L s at 14L s PEF 0 840 L min BTPS FEV1 0 9 99 L BTPS EN ISO 23747 2007 CISPR 11 Group 1 battery operated IEC 61000 4 2 IEC 61000 4 3 battery operated Stator rotor 2x AAA batteries 17 37 C Set to 2 minutes as standard Your Vitalograph asma 1 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 99 Street Lenexa Kansas 66215 USA Tel 913 888 4221 Fax 913 888 4259 Email vitcs vitalograph com www vitalograph com Vitalograph GmbH Jacobsenweg 12 22525 Hamburg Germany Tel 040 547391 0 Fax 040 547391 40 Email info vitalograph de www vitalograph de Vitalograph Ireland Ltd Gort Road Business Park Ennis Co Clare Ireland Tel 065 6864100 Fax 065 6829289 Email sales vitalograph ie www vitalograph ie Copyright and trademarks Vitalograph BVF SafeTway and copd 6 are trademarks of Vitalograph Ltd Appendices Quick Start Guide Testing Subject a Insert Mouthpiece and D Switch On CD Switch On Q Best blow N a PEF 5 FEVI 3 Ty Press 4 4 to exit or Delete History
10. his procedure may be repeated until the optimum Action Plan is proven The Personal Best is the best PEF or FEV1 value that the sufferer can achieve this is the 100 or reference value Population normative standards are not clinically useful in ongoing serial monitoring of the asthma How To Use The Vitalograph asma 1 Setting Personal Best Reference Values Personal Best reference values can be set for peak flow PEF and or forced expiratory volume after 1 second FEV 1 To set the Personal Best reference PEF follow these steps 1 Turn the device on 2 When the device is ready for a test Gs press the A and V buttons together for 3 seconds 3 The reference PEF value can now be set This is done by pressing the A button and releasing when the value is reached Press the to roll back The values will increase decrease in values of 10 If the button is kept depressed the values will scroll faster 4 Press lt to keep this reference PEF value Press again to exit or to set the Best Test reference FEV1 1 The reference FEV1 value is set by pressing the A 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 2 Press ENTER to keep this reference FEV1 value The device will return to the test screen Note to de activate zones set both the PEF and FEV1
11. mately 3 seconds and an arrow will indicate which colour management zone this relates to if the Personal Best has been set 7 With the blow icon showing blow again G Usually 3 blows are required 8 To view the best test in the session best PEF and best FEV1 press the button This is the value that is recorded for the session in the device history Note if an exclamation mark appears this means it was not a good quality blow and the subject should blow again If the subject experiences dizziness or fatigue during the test session wait until this passes before blowing again or terminate the session For a good test the time to peak flow must be 120ms or less and no cough in the 1st second Reviewing Previous Results The Vitalograph asma 1 can store up to 600 test sessions In order to view previously performed test sessions follow these steps 1 2 3 9 Turn the device on When the device is ready for a test G gt press the lt button for approximately 3 seconds The most recent test session will now be displayed The best PEF result will be displayed for approximately 3 seconds followed by the best FEV1 result The session number 1 is also displayed this is the latest session Earlier test sessions can also be viewed Pressing the A button will show 2 the previous test and so on Press The device will return to the test screen Deleting All Results History Caution Once th
12. reference values to 000 0 00 Setting Management Zones The Vitalograph asma 1 can be set for use with 3 or 4 zone management plans The zone percentages are factory set to 2 boundaries 80 amp 50 i e 3 Zones 80 100 50 80 0 50 For 4 zones the middle boundary is set last The colour systems for each zone type are as follows Top boundary Top boundary Middle boundary Bottom boundary Bottom boundary 3 Zone 4 Zone To set the boundary percentage values for 3 zones follow these steps 1 Turn the device on 2 When the device is ready for a test G gt press and hold the and A buttons for approximately 3 seconds 3 The top Green Yellow boundary can now be set This is done by pressing the A or button and releasing when the value is reached The values will increase decrease in values of 1 If the button is kept depressed the values will scroll faster 4 Press to set the top Green Yellow boundary value 5 The bottom Yellow Red boundary can now be set This is done by pressing the A or Y button and releasing when the value is reached The values will increase decrease in values of 1 If the button is kept depressed the values will scroll faster 6 Press lt to set the bottom Yellow Red boundary value 7 Only 2 boundaries are required for the 3 zone system so the next value should be selected as 0 default Press 4 The device will return to the test screen To set the boundar
13. rs 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 watts w according to the transmitter manufacturer Note 1 at 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 these guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Declaration of Conformity Product Vitalograph asma 1 Vitalograph hereby ensures and declares that the above product associated with this user manual is designed and manufactured in accordance with the following QMS regulations and standards European Medical Devices Directive MDD 93 42 EEC This device classified as 2a as per Annex IX of MDD 93 42 EEC meets the following provisions of Annex Il of the Medical Devices Directive as per Article 0086 11 section 3a excluding point 4 of Annex Il 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 devices Quality management systems Requirements for regulatory purposes Certifying Body for 93 42
14. tempt 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 Alcohol impregnated cloth provides a suitable form of cleaning and low level disinfection for the case exterior Repeat this at least weekly to prevent a build up of grime from normal handling and use Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment Consumables Accessories and Spare Parts Cat No Description 40161 Plastic Mouthpiece for asma 1 Pack of 12 20303 Disposable Noseclips 200 20242 SafeTway disposable mouthpieces 200 20980 Mini SafeTway mouthpieces 50 28350 BVF Bacterial Viral Filters 50 Explanation of Symbols Device symbols gt it oo Type BF equipment Class Il The device must be taken 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 Memory Symbol Battery status Full Battery status Half Battery status Empty flashing Blow Now Symbol Bad Test Symbol Cough or tPEF gt 120ms Technical Specifications Material Accuracy Flow Impedance Measurement Range Performance And Safety Standards Electromagnetic emissions Electromagnetic immunity Sensor Power Supply Operating Temperature Auto pow
15. twork that supplies buildings used for domestic purposes The Vitalograph asma 1 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 e Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 e Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment e Interference may occur in the vicinity of equipment marked with the following symbol FDA Notice Caution Federal Law restricts this device to sale by or on the order of a physician Recommended separation distances between portable and mobile RF communication equipment and the system The Vitalograph asma 1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter m max mum 450 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz output Gower oi d 1 2 P d 2 3 P transmitter For transmitte
16. y percentage values for 4 zones follow these steps 1 First set the top and bottom boundaries see above procedure steps 1 6 2 The middle Yellow Orange boundary can now be set This is done by pressing the A button and releasing when the middle boundary value is reached The values will increase decrease in values of 1 after an initial jump to the lower boundary value If the button is kept depressed the values will scroll faster This boundary value can not be set at a value that is greater than the top boundary value or less than the bottom boundary value 3 Press to set the middle Yellow Orange boundary value The device will return to the test screen Performing The Test 1 Sit down when blowing into the device 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 G gt holding the head high breathe in as deeply as possible hold the Vitalograph asma 1 ready in front of the mouth 4 Holding the breath place the mouthpiece into the mouth biting the mouthpiece lightly and with the lips firmly sealed around it 5 Blow out as HARD and as FAST as possible for a second or more Be careful not to block the mouthpiece with the tongue or teeth A spitting action will give false readings 6 The PEF result for this blow will be displayed followed by the FEV1 result after approxi
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