User Manual
Contents
1. italographi COP d 6 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 Advisory Notices cccccccsecceeeeeeseeeeeeeeeseeeaeeaees Main Components of the Vitalograph Copd 6 7 eeeeeseeereeeeeee What Is The Vitalograph copd 6 Used For c ccccceccsesecereeereeee What Is The Vitalograph copd 6 Used For c cccccccsesecereeereeee How To Use The Vitalograph COpd 6 7 o ee cecsececerseceeereeereeereeee Entering Subj ct Datla ssar E E eevee tees P enornminNg INC TOST er Ea EAERI Setting The Obstructive Index and COPD Classification Zones Reviewing the Last Session Test R SUIES ccccccceeceeeneeeeees Care and Cleaning Of The Vitalograph copd 6 oo eee eeeeeeeeereee Table of Materials Used amp Cleaning Disinfection Methods Consumables Accessories and Spare Parts cccsecseeeeeeeees EXDIaMatlON Ol SY MDOIS 12x cescvercesceuaseectee cect eerenteeesesueeeeaa ent Technical Specifications cccccssssccssssrsceeursssccursurscsccseuursesccessas VV IP aa seacuestaacesseeiananersseccnesneseeaee Appendices nnnnnnenononnnnnnonrnnnnrrrnrnrsnrnrnrnrrrrnrnrnrrrrnrnrnrrnrnrnernenrnno QUICK Sl GUIGC rr eni TT aaeetieas Regulatory Notices for the Vitalograph copd 6 CE NOCO acetic ea nie se as asa2. 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 EEC and CMDR British Standards Institute BSI Certificate Nos CE 00772 MD 82182 FM 83550
3. to change height Press H to set Test Result ae Press H to show result Y spirometry not required Y COPD Classification green Positive Positive Y Refer for spirometry Y COPD Classification to IV 12 Set test subject s gender Press or Y to change gender Press lt 4 to set 7 amp Set test subject s population group Press JA or y to change population group Press 4H to set Q No Population Group ret European default ERS 1903 _ Japaneses SSCS ERT a Afican American NHANES ee ooo i o AJ and Weight kg above evelght not normally required View Parameters 1 Display shows FEV and of predicted amp Press V to show FEV6 and of predicted Ep Press Yy to show FEV Ratio and of predicted 4 Press W to show Lung Age www vitalograph co uk Perform Test Insert disposable SafeTway mouthpiece a Demonstrate to test subject Fully breathe in hold Insert and lightly bite the mouthpiece Then blow as hard as possible for 6 s wait for beep WELL DONE Rest test subject for a short while and wait for blow icon to reappear Repeat blow 2 more times Bad blow Regulatory Notices for the Vitalograph copd 6 CE Notice Marking by the symbol C indicates compliance of the Vitalograph copd 6 to the Medical Devices Directive of the European Community Such marking is indicative that the Vitalograph copd 6 mee
4. Cleaning of Medical Equipment Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate 1996 Recommendations for chemical disinfectants are derived from the PHLS publication Chemical Disinfection in Hospitals 1993 Consumables Accessories and Spare Parts Cat No Description 20242 Safe Tway Mouthpieces 200 20303 Disposable Noseclips 200 20980 Mini SafeTway mouthpieces 50 28350 BVF Bacterial Viral Filters 50 Explanation of Symbols Device symbols o H A 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 Cc Ge kglb Battery status Full Battery status Half Battery status Empty flashing Blow Now Symbol Bad Test Symbol Slow start or Cough Unit of weight measurement Lung Age Symbol Age Symbol Height Symbol Gender Symbol Population Group Symbol Technical Specifications Material Accuracy Flow Impedance Measurement Range Performance And Safety Standards Electromagnetic emissions Electromagnetic immunity Sensor Power Supply Operating Temperature Bad Test Criteria FEV substituted for FEV6 Auto power down time Warranty PC ABS Better than 3 Better than 0 15kPa L s at 1
5. 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 provides clinical users with information to allow the assessment of other suitable cleaning and disinfecting procedures available in their facility Part Cleaning Disinfection Recommendation Recommendation PC ABS Wipe with a damp Alcohol wipe IPA 70 90 cloth Fascia Polycarbonate Wipe with a damp Alcohol wipe IPA 70 90 cloth Synthetic Rubber Wipe with a damp Alcohol wipe IPA 70 90 cloth All external parts of the Vitalograph copd 6 require cleaning i e the removal of visible particulate contamination 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 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 Definitions of cleaning and disinfection are as defined in Sterilization Disinfection and
6. 4L s 0 9 99 L BTPS ATS ERS Guidelines 2005 CISPR 11 Group 1 battery operated IEC 61000 4 2 IEC 61000 4 3 battery operated Stator rotor 2 x AAA batteries 17 37 C Slow start of test Vext gt 5 or a cough detected in the first second When FET lt 3s and abrupt end of test Set to 2 minutes as standard Your Vitalograph copd 6 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 Prepare Device 1 D Switch On Set test subject s age Press or Yy to change age Press H to set Set test subject s height Press or Y
7. COPD FEV1 FEV6 gt 0 7 Stage FEV1 FEV6 lt 0 70 and FEV1 2 80 Pred Top boundary Stage II FEV1 FEV6 lt 0 70 and FEV1 lt 80 Pred Middle boundary Stage III FEV1 FEV6 lt 0 70 and FEV1 lt 50 Pred Bottom boundary Stage IV FEV1 FEV6 lt 0 70 and FEV1 lt 30 Pred To set the boundary percentage values for both the Obstructive Index and COPD Classification zones together follow these steps 80 lt 80 lt 50 lt 30 1 Turn the device on 2 When the Tf icon appears press and hold the and A buttons for approximately 3 seconds 3 The top 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 boundary value 5 The middle 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 6 Press to set the middle boundary value 7 The bottom 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 8 Press to set the bottom boundary value 9 Press The device will
8. asia scans esis FANO O fates chce ape hatte ects eice a atin tate Declaration Of Conformity ccccccceecseececcseccecseecseesseeeseeeeesens Copyright Vitalograph 2007 Print Ref No 07381 EAEE EE AE EEIE TETTETETT 4 E A A 5 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 the 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 copd 6 A B C D Flowhead On off button Display User buttons What Is The Vitalograph copd 6 Used For The Vitalograph copd 6 is a device intended for measuring lung function It can be use
9. d by a healthcare professional or assistant as a rapid pre spirometry test to screen out at risk individuals that do not have COPD and indicate those that may be at risk of COPD at the pre symptomatic stage of the disease This screening or case selection for full spirometry examinations may result in earlier medical intervention and facilitate better clinical outcomes The Vitalograph copd 6 displays some key parameters for clinical interpretation e FEV1 and FEV1 Predicted e FEV6 and FEV6 Predicted e FEV1 FEV6 and FEV1 FEV6 Predicted lf an abnormal result is indicated arrows on the display shows e Obstructive Index e COPD Classification stages IV How To Use The Vitalograph copd 6 Entering Subject Data The subject s physical data can be entered into the Vitalograph copd 6 in order to calculate predicted data To enter the subject data follow these steps 1 Turn the device on 2 The age can now be set TP This is done by pressing the A or Y 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 h This is done by pressing the A or button and releasing when the height 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
10. height Note if height values are set below 100 the device assumes height is in inches and that Weight will be in Ibs rather than Kg 4 The gender can now be set S This is done by pressing the A or Y button and releasing when the correct gender is showing Male S Female Press the button to set the gender After gender is selected the Vitalograph copd 6 will go to Test Mode where the Blow Icon is showing On some variants an additional data field comes first see below 5 This step may be omitted depending on the variant The Population Group on some variants this is Weight instead can now be set Y This is done by pressing the A or Y button and releasing when the desired setting is reached Press the button to set set Example Population Group NHANES III Caucasian NHANES III African American NHANES III Hispanic American Performing the Test 1 2 3 N 4 5 The subject should sit down when blowing into the device unless advised otherwise Insert a new disposable SafeTway mouthpiece into the device Turn the device on if not already ON When the device is ready for a test the blow icon shows Ge Instruct the subject and demonstrate using a mouthpiece as follows a Hold your head up breathe in as deeply as possible hold the device in front of your mouth b Hold your breath place the mouthpiece into your mouth like this bite the mouthpiece lightl
11. 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 maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz output _ _ Gower oi d 1 2 VP d 2 3 P transmitter 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 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 copd 6 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
12. lt button has been pressed Pressing again will toggle between best and last blow 7 Pressing the A button will show the FEV6 and FEV6 Predicted results 8 Pressing the A button again will show the FEV1 FEV6 and FEV1 FEV6 Predicted results 9 Press the A button for a final time will show the estimated Lung Age ba Notes on testing 1 During testing if an exclamation mark appears this means that the last blow was not a good quality blow and the user should blow again Reasons for poor quality are a Slow Start of test Vext extrapolated volume is gt 5 or 150mL of FEV6 b Cough detected 2 In the event that a test is lt 3 seconds duration and has an abrupt end change in volume is gt 25ml in the last second of the test the value FEV will be displayed instead of FEV6 3 Ifthe test subject experiences side effects such as dizziness or fatigue during the test procedure stop testing until recovered Setting The Obstructive Index and COPD Classification Zones The Vitalograph copd 6 Obstructive Index and COPD Classification zones are set by the manufacturer to the GOLD Global Initiative for Chronic Obstructive Lung Disease standard and it is unlikely that a user will wish to change this however if this is required please follow the following instructions The colour systems for each zone type are pre set as follows FEV1 Pred Obstructive COPD FEV1 FEV6 Ratio and FEV1 Pred Index Classification Not
13. return to the age entry screen Reviewing the Last Session Test Results The Vitalograph copd 6 will always store the last test session even after the device has powered itself down or has been switched OFF In order to view the last test session follow these steps 1 Turn the device on 2 When the device is ready for age entry 7 press the 4 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 3s OR 4 Press The device will return to the age entry screen ready for entering the next test subject s data Care and Cleaning Of The Vitalograph copd 6 A new mouthpiece either Safe way 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 disinfection 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
14. ts or exceeds the referenced technical standards The Vitalograph copd 6 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 copd 6 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 network that supplies buildings used for domestic purposes The Vitalograph copd 6 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 2 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 copd 6 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
15. y and seal your lips firmly around it like this will demonstrate c Blow out as HARD and FAST as you can like this until tell you to stop the unit will beep at end of test after 6 seconds d Be careful not to block the mouthpiece with your tongue or teeth A spitting action will give false readings e Now you do it deep breath in bite and seal 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 To view the result the best values in the session press the lt button a The COPD Classification will show on the right hand arrow i Green is NORMAL negative for COPD No need to refer this subject for spirometry li Any one of the blue zones I Il Il or IV are not normal This subject should be referred for spirometry b The Obstructive Index Ol shows on the left hand arrow i O Green is normal li 1 2 or 3 Yellow amber or red are not normal Refer for spirometry but this is unlikely to be COPD iii Note If the right hand COPD arrow is not green nor will the left hand Ol arrow be green This is the end of the test but if desired some test parameters may be viewed 6 Following each blow and at the end of the test session the FEV1 value will be displayed and below that FEV1 Predicted results for that blow or for the best in session if the
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