User Manual - Medical Supermarket
Contents
1. italograph 4000 Respiratory Monitor lung monitor USD User Manual Medical Devices Directive 93 42 EEC L169 Vol 36 EN ISO 13485 FDA QSR 21 CFR 820 803 Manufacturer Vitalograph Ireland Ltd Ennis Ireland Page I of 22 DT_0006 6 Vitalograph Ltd Maids Moreton Buckingham MK181SW England Tel 44 0 1280 827110 Fax 44 0 1280 823302 e mail sales vitalograph co uk Vitalograph Inc 13310 West 99 Street Lenexa Kansa 66215 USA Tel 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com www vitalograph com Copyright Vitalograph 2009 2010 Current Edition Issue 2 Cat No 07515 Vitalograph GmbH Jacobsenweg 12 22525 Hamburg Germany Tel 040 547391 0 Fax 040 547391 40 e mail info vitalograph de Vitalograph Ireland Ltd Gort Road Business Park Ennis Co Clare Ireland Tel 065 6864100 Fax 065 6829289 e mail sales vitalograph ie ftalographi is a registered trademark Page 2 of 22 DT_0006 6 Table of Contents WARNINGS AND ADVISORY NOTICES 4 MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR USB 5 WHAT IS THE VITALOGRAPH LUNG MONITOR USB USED FOR 5 HOW TO USE THE VITALOGRAPH LUNG MONITOR USB SETTING PERSONAL BEST REFERENCE VALUES SETTING MANAGEMENT ZONES PERFORMING THE TEST REVIEWING PREVIOUS RESULTS DELETING ALL RESULTS HISTORY SENDING TEST RESULTS TO VITALOGRAPH REPORTS CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR OO2. 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 Page 11 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 Clean Autoclave Recommended Disinfect Possible Disinfectants Plastic Do not use No Disinfect by immersion Mouthpiece in clinic in sodium dichloroisocyanurate solution at 1000ppm concentration of free chlorine for 15 minutes SafeTway Cardboard Dispose Dispose single use mouthpiece ABS single use or BVF Exterior n Removable ABS Clean flowhead Stainless Steel All external parts of the Vitalograph lung monitor require cleaning i e the removal of visible particulate contamination The parts of the device that make up the flowhead which comes into contact with the breath of the subjects being tested also require disinfecting 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 This may be preceded by cleaning with an anti static foam cleaner if necessary Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes see following section for recommended cleaning disinfection meth
3. 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 GUARANTEE Subject to the conditions listed below Vitalograph Ltd and its associated companies hereinafter called the Company guarantee to repair or at its opinion replace any component thereof which in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials The conditions of this Guarantee are 1 This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment unless otherwise agreed in writing by the Company 2 Software meaning computer software or user installable modules is guaranteed for 90 days from the date of purchase 3 The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company s literature and user manuals The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above provided that the failure 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 does not cover any faults caused by accident misuse neglect tampering with the equipment use of consumable items or parts not approved by the Company or any attem
4. 0 MHz in ISM bands 3 V 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 including cables than the recommended separation distance calculated form the equation applicable to the frequency of the transmitter Recommended separation distance d 0 354P d 0 354 P 80MHz to 800MHz a 0 74 P 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 Te Recommended separation distances between portable and mobile RF communication equipment and the 4000 Respiratory Monitor lung monitor The 4000 Respiratory Monitor lung monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the 4000 Respiratory Monitor lung monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF commu
5. 00 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Page 18 of 22 6 kV contact 6 kV contact 8 kV air 8 kV air 2 kV for power supply lines 1 kV for input output lines 1kV differential mode 2kV common mode Battery operated device Battery operated device lt 5 100V gt 95 dip in 100V for 0 5 cycle 40 100V 60 dip in 700V for 5 cycles 70 100V 30 dip in 700V for25 cycles lt 5 100V gt 95 dip in 100V for 5 sec Battery operated device Performance A Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 hospital environment Guidance and manufacturer s declaration electromagnetic immunity The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below The customer or the user of the 4000 Respiratory Monitor lung monitor should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment test Test level level guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Page 19 of 22 10 Vrms 150kKHz to 8
6. 07515 Issue 2 1 Connect the Vitalograph lung monitor USB device to the PC using the USB cable supplied 2 On Vitalograph Reports ensure Vitalograph lung monitor is selected as the device 3 There are two ways to print the test results from the lung monitor a When the device is ready for a test Ys press the A button for 3 seconds on the device will show the Report b After completing the test session press the A or Y button until the print 45 screen is displayed Press 4 On the Vitalograph Reports enter the Subject Demographic details and Comments Select Continue on Vitalograph Reports when you are finished entering the information 5 Select a location for the test report on your PC as requested by Vitalograph Reports A PDF of the test results will appear and will also be stored to the PC CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR USB Home use cleaning and disinfection of the Vitalograph lung monitor The Vitalograph lung monitor should continue to give reliable measurements for up to three years in home use Then replace it with a new device Keep it clean and dust free If you suspect the device is damaged or is measuring incorrectly contact the doctor immediately 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 alc
7. 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided Portable and mobile RF communications equipment can affect medical electrical equipment FDA NOTICE Caution Federal Law restricts this device to sale by or on the order of a physician DECLARATION OF CONFORMITY Product italograplif 4000 Respiratory Monitor lung monitor 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 0086 Medical Devices Directive as per Article 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 QASR 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 Page 21 of 22 DT_0006
8. 6 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 boundary 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 cannot be set at a value that is greater than the top boundary value or less than the bottom boundary value Page 7 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 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 SafeT way mouthpiece in clinic 3 When the device is ready for a test Ys holding the head high breathe in as deeply as possible hold the Vitalograph lung monitor 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 seal
9. O ANDNN A USB 10 HOME USE CLEANING AND DISINFECTION OF THE VITALOGRAPH LUNG MONITOR 10 CLEANING AND DISINFECTING THE VITALOGRAPH LUNG MONITOR IN CLINIC USE 11 Table of Materials Used amp Cleaning Disinfection Methods Il Removing the Flowhead for Cleaning and Disinfecting 13 CONSUMABLES ACCESSORIES AND SPARE PARTS 14 EXPLANATION OF SYMBOLS 15 TECHNICAL SPECIFICATIONS 16 CE NOTICE 17 FDA NOTICE 21 DECLARATION OF CONFORMITY 21 GUARANTEE 22 Page 3 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 WARNINGS AND ADVISORY NOTICES Note Please read all the information in this manual before using the Vitalograph lung monitor USB device A full set of instructions including cleaning instructions is available at www vitalograph co uk e The Vitalograph lung monitor is recommended for single patient use e The Vitalograph lung monitor should be only used under the supervision of a healthcare professional e Symptoms must take precedence over device measurements e f the device is used for longer than its specified life the accuracy of the device may deteriorate e 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 not reading correctly they must advise the healthcare professional immediately Medical facilities may use a precision syringe to check the accuracy o
10. d 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 ENTER to keep this reference FEV1 value The device will return to the test screen Note to de activate zones set the FEV1 reference value to 0 00 Setting Management Zones The Vitalograph lung monitor can be set for use with 3 or 4 zone management plans The zone percentages are factory set to 2 boundaries 95 amp 90 i e 3 Zones 95 100 90 95 0 90 For 4 zones the middle boundary is set last The colour systems for each zone type are as follows Page 6 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 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 press the A and lt buttons together for approximately 10 seconds 3 The top Green Yellow boundary can now be set This is done by pressing the A or Y button and releasing when the value is reached 4 Press ENTER 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 Press to set the bottom Yellow Red boundary value
11. ed around it 5 Blow out as HARD as FAST and as LONG as possible the device will stop taking readings after 6 seconds Be careful not to block the mouthpiece with the tongue or teeth A spitting action will give false readings 6 Following each blow and at the end of the test session the FEV1 value will be displayed and below that FEV1 Personal Best results for that blow 7 Pressing the A button will show the FEV6 result 8 Pressing the A button again will show the FEV1 FEV6 result 9 Pressing the A button again will show the FEF25 75 result 10 With the blow icon showing blow again Ys Usually 3 blows are required 11 To view the best test in the session best FEV1 and best FEV6 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 appears when The Vext extrapolated volume is gt 5 or 150mL of FEV6 or a cough is detected in the 1 second Page 8 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 lf the subject experiences dizziness or fatigue during the test session wait until this passes before blowing again or terminate the session Reviewing Previous Results The Vitalograph lung monitor can store up to 200 test sessions In order to view previously performed test sessions follow these steps 1 Turn the d
12. evice on 2 When the device is ready for a test G press the button for approximately 3 seconds 3 The most recent test session will now be displayed The best FEV1 result will be displayed for approximately 3 seconds followed by the best FEV6 result The session number 1 is also displayed this is the latest session 4 Earlier test sessions can also be viewed Pressing the A button once will show 2 the previous test and so on 5 Press The device will return to the test screen Deleting All Results History Caution Once the history has been deleted it cannot be recovered To delete the history 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 Qs press the V and buttons simultaneously for approximately 10 seconds 3 Along beep will indicate success and the device will return to the test screen Sending Test Results to Vitalograph Reports The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be stored as a PDF file and viewed or printed Before you can transmit you must first have the Vitalograph Reports Utility installed and running on your PC If the Snake V icon is showing in your PC System Tray then the utility is running if not refer to Vitalograph Reports Utility instructions Page 9 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N
13. f this device Page 4 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR USB A Flowhead B On off button C Display D User buttons E USB connector WHAT IS THE VITALOGRAPH LUNG MONITOR USB USED FOR The Vitalograph lung monitor USB is an easy to use home monitoring device designed to record key lung function parameters for those with respiratory conditions including cystic fibrosis and transplant patients The lung monitor can also be used in primary and secondary care occupational health and clinical studies The primary features of the Vitalograph lung monitor are e Measures FEV1 FEV6 and the ratio Page 5 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 Displays of personal best FEV1 Simple to use Electronic record eliminating need for record cards Stores 200 test sessions Quality of blow indicator FEV1 zones can be personalized Uses disposable AAA batteries How To USE THE VITALOGRAPH LUNG MONITOR USB Setting Personal Best Reference Values Personal Best reference values can be set for forced expiratory volume after 1 second FEV1 To set the Personal Best reference FEV 1 follow these steps 1 Turn the device on 2 When the device is ready for a test Qs press the V and A buttons together for 3 seconds 3 The reference FEV1 value is set by pressing the A button an
14. ions The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below The customer or the user of 4000 Respiratory Monitor lung monitor should assure that it is used in such an an 4000 Respiratory Monitor lung monitor 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 RF emissions Class B The 4000 Respiratory Monitor lung monitor is CISPR 11 Suitable for use in all establishments including Harmonic emissions Class A domestic establishments and those directly IEC 61000 3 2 Class A Feonnected to the public low voltage power ly network that lies buildings used for Voltage fluctuations oe supplies buildings u Page 17 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 Guidance and manufacturer s declaration electromagnetic immunity The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below The customer or the user of the 4000 Respiratory Monitor lung monitor should assure that it is used in such an environment Immunity test IEC 60601 Compliance Test level level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 610
15. nications equipment transmitters and the 4000 Respiratory Monitor lung monitor as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of output power of transmitter m transmitter 150 kHz to 80 80 MHz to 800 800 MHz to 2 5GHz MHz MHz d 2 3 P d 1 2 P d 1 2 P For transmitters rated at a maximum output power not listed above the recommended separation distance din 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 Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible If interference is suspected or possible switching off the offending device is the normal solution as is required in aircraft and medical facilities Page 20 of 22 DT_0006
16. od for the Vitalograph COMPACT Flowhead The flowhead may also be disinfected by autoclaving at 134 C for 3 minutes or 120 C for 20 minutes Definitions of cleaning and disinfection are as defined in Sterilization Disinfection and Cleaning of Medical Equipment Page 12 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 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 Removing the Flowhead for Cleaning and Disinfecting 1 Remove the flowhead from the body with a sharp pulling motion 2 Clean the flowhead by washing in a mild detergent to remove particulate contamination taking care not to touch the moving vanes Swill vigorously in water ni mild detergent Do not attempt to rub o tals scrub in the area of the vanes Rinse with clean water 3 Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration 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 Drying the flowhead may require placing it in a warm place overnight A drying cabinet is ideal Wiping with a 70 Isopropyl Alcohol impregnated clo
17. ohol wipe paying special attention to the mouthpiece area Page 10 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 a aad a Recommendation Recommendation eae ate Mouthpiece water Rinse in clean Effervescent water Chlorine E cloth 70 90 ET cloth 70 90 Rubber cloth 70 90 Cleaning and Disinfecting the Vitalograph lung monitor 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 lt 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 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
18. pt at adjustment or repair other than by personnel accredited by the Company nor does it cover reinstatement of any configuration changes caused by the installation of any software 5 If a defect occurs please contact the supplier from whom it was purchased for advice The Company does not authorise any person to create for it any other obligation or liability in connection with Vitalograph equipment 6 This Guarantee is not transferable and no person firm or company has any authority to vary the terms or conditions of this Guarantee 7 To the maximum extent permitted by law the Company does not accept liability for any consequential damages arising out of the use of or inability to use any Vitalograph equipment 8 This Guarantee is offered as an additional benefit to the Consumer s statutory rights and does not affect these rights in any way Page 22 of 22 DT_0006 6
19. th provides a suitable form of cleaning and low level disinfection for the case exterior display screen surround and keys 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 Reassemble the flowhead by pushing back on until it clicks into position Ensure that the flowhead is pushed fully home When the flowhead Is reassembled it is good practice with any respiratory measuring device for an accuracy check be performed Page 13 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 using a Precision Syringe with the volume delivered in less than one second An accuracy of 3 should be achieved CONSUMABLES ACCESSORIES AND SPARE PARTS Cat No Description 40168 Mouthpiece 20 20242 SafeTway Mouthpieces 200 20303 Disposable Noseclips 200 20980 Mini SafeTway mouthpieces 50 20991 Long SafeTway mouthpieces 130 28350 BVF Bacterial Viral Filters 50 40167 Pouch Spare x10 Page 14 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 EXPLANATION OF SYMBOLS Device symbols o ps4 JN ORD User Interface Symbols m Type BF equipment Class II The device must be taken to separate collection at the product end of life Do not dispose of these products as unsorted municipal waste A
20. ttention reference relevant section in manual USB connector Battery status Battery status Full Battery status Half Battery status Quarter Battery status Empty flashing Blow Now Symbol Bad Test Symbol Slow start or Cough Transmit Report Symbol Page 15 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 TECHNICAL SPECIFICATIONS Material PC ABS Accuracy Better than 3 Flow Impedance Better than 0 15kPa L s at 14L s Measurement Range 0 9 99 L BIPS Performance And Safety ISO EN 23747 2007 Standards ATS ERS Guidelines 2005 Electromagnetic CISPR 11 Group 1 battery operated emissions Electromagnetic IEC 61000 4 2 IEC 61000 4 3 battery immunity operated Sensor Stator rotor Power Supply 2 x AAA batteries Operating Temperature 17 37 C Bad Test Criteria Slow start of test Vext gt 5 or a cough detected in the first second Auto power down time Set to 2 minutes as standard Communications USB Page 16 of 22 DT_0006 6 Vitalograph lung monitor USB User Manual P N 07515 Issue 2 CE NOTICE Marking by the symbol CE indicates compliance of the Vitalograph 4000 Respiratory Monitor lung monitor device to the Medical Devices Directive of the European Community Such marking is indicative that the Vitalograph 4000 Respiratory Monitor lung monitor device meets or exceeds the following technical standards uidance and manufacturer s declaration electromagnetic emiss
Download Pdf Manuals
Related Search