User Manual - Vitalograph
Contents
1. Page 18 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Guidance and manufacturer s declaration electromagnetic immunity The 4000 Respiratory Monitor copd 6 is intended for use in the electromagnetic environment specified below The customer or the user of the 4000 Respiratory Monitor copd 6 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 80 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 copd 6 including cables than the recommended separation distance calculated form the equation applicable to the frequency of the transmitter Recommended separation distance d 0 35VP d 0 354 P 80MHz to 800MHz d 0 7 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 w2. Page 17 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Guidance and manufacturer s declaration electromagnetic immunity The 4000 Respiratory Monitor copd 6 is intended for use in the electromagnetic environment specified below The customer or the user of the 4000 Respiratory Monitor copd 6 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic Test level level environment guidance Electrostatic 6 kV contact 6 kV Floors should be discharge ESD contact wood concrete or IEC 61000 4 2 8 kV air ceramic tile If floors 8 kV air are covered with synthetic material the relative humidity should be at least Electrical fast 2 kV for power Battery transient burst supply lines operated 1 kV for input device IEC 61000 4 4 output lines Surge 1kV differential Battery IEC 61000 4 5 mode 2kV operated common mode device Voltage dips lt 5 100V Battery short interruptions gt 95 dip in operated and voltage 100V for 0 5 device variations on cycle power supply 40 100V 60 input lines dip in 700V for 5 cycles IEC 61000 4 11 70 100V 30 dip in 100V for25 cycles lt 5 100V gt 95 dip in 100V for 5 sec Power frequency Performance Power frequency 50 60 Hz A magnetic fields should magnetic field be at levels characteristic of a IEC 61000 4 8 typical location in a typical commercial or hospital environment
3. italograph 4000 Respiratory Monitor COPa 6 USb 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 l 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 2008 2010 Current Edition Issue 2 Cat No 07409 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 fitalographi is a registered trademark Page 2 of 22 DT_0006 6 Table of Contents WARNINGS AND ADVISORY NOTICES 4 MAIN COMPONENTS OF THE VITALOGRAPH COPD 6 USB 5 WHAT IS THE VITALOGRAPH COPD 6 USB USED FOR 5 HOW TO USE THE VITALOGRAPH COPD 6 USB 6 ENTERING SUBJECT DATA 6 PERFORMING THE TEST 7 SENDING TEST RESULTS TO VITALOGRAPH REPORTS 9 SETTING THE OBSTRUCTIVE INDEX AND COPD CLASSIFICATION ZONES 10 REVIEWING THE LAST SESSION TEST RESULTS 11 CARE AND CLEANING OF THE VITALOGRAPH COPD 6 USB 11 DAILY PROCEDURES 11 MONT
4. low level disinfection This may be preceded by cleaning with an anti static foam cleaner if necessary Page 12 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Removable PC ABS Clean No Disinfect by flowhead immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes see following section for recommended cleaning disinfection method for the flowhead All external parts of the Vitalograph copd 6 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 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 with mild detergent Do not attempt to rub or 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 Dryin
5. 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 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 Page 21 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 u
6. HLY PROCEDURES 12 ANNUAL PROCEDURES 12 TABLE OF MATERIALS USED amp CLEANING DISINFECTION METHODS 12 REMOVING THE FLOWHEAD FOR CLEANING AND DISINFECTING 13 CONSUMABLES ACCESSORIES AND SPARE PARTS 14 EXPLANATION OF SYMBOLS 15 TECHNICAL SPECIFICATIONS 16 CE NOTICE 16 FDA NOTICE 21 DECLARATION OF CONFORMITY 21 GUARANTEE 21 Page 3 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 WARNINGS AND ADVISORY NOTICES Note Please read all the information in this manual before using the Vitalograph copd 6 USB device 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 USB device for operation and accuracy Page 4 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 MAIN COMP
7. ONENTS OF THE VITALOGRAPH COPD 6 USB A Flowhead B On off button C Display D User buttons E USB connector WHAT IS THE VITALOGRAPH COPD 6 USB USED FOR The Vitalograph copd 6 USB is a device intended for measuring lung function It can be used 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 Page 5 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 The Vitalograph copd 6 USB displays some key parameters for clinical interpretation e FEV1 and FEV1 Predicted e FEV6 and FEV6 Predicted e FEV1 FEV6 and FEV1 FEV6 Predicted e FEV1 FVC ratio If an abnormal result is indicated arrows on the display show e Obstructive Index e COPD Classification stages IV How To USE THE VITALOGRAPH COPD 6 USB Entering Subject Data The subject s physical data can be entered into the Vitalograph copd 6 USB 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 TY This is done by pressing the A or button and releasing when the age is reached The values will increase decrease in values
8. cts such as dizziness or fatigue during the test procedure stop testing until recovered 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 1 Connect the Vitalograph copd 6 USB device to the PC using the USB cable supplied 2 On Vitalograph Reports ensure Vitalograph copd 6 is selected as the device 3 There are two ways to print the test results from the copd 6 a When the device is ready for a test Ys press the A button for 3 seconds on the device will show the Report icon b After completing the test session press the A or Y button until the print 45 screen is displayed Press Page 9 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 Setting the Obstructive I
9. et 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 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 Press to set the bottom boundary value Press The device will return to the age entry screen Reviewing the Last Session Test Results The Vitalograph copd 6 USB 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 ti 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 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 USB Daily Procedures A new mouthpiece either Safe Tway 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 par
10. g the flowhead may require placing it in a warm place overnight A drying cabinet is ideal Wiping with a 70 Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low level disinfection for the case Page 13 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 using a Precision Syringe with the volume delivered in less than one second An accuracy of 3 should be achieved Definitions of cleaning and disinfection are as defined in Sterilization Disinfection and 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 SafeTway Mouthpieces 200 20303 Disposable Noseclips 200 20980 Mini SafeTwa
11. ith the following symbol Ko DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Recommended separation distances between portable and mobile RF communication equipment and the 4000 Respiratory Monitor copd 6 The 4000 Respiratory Monitor copd 6 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 copd 6 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the 4000 Respiratory Monitor copd 6 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 fro
12. m 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 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided Page 20 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 italograpif 4000 Respiratory Monitor 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 0086 Medical Devices Directive as per Article 11 section 3a
13. ndex and COPD Classification Zones The Vitalograph copd 6 USB 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 Index Classification FEV1 Pred gt 80 Not COPD FEV1 FEV6 gt 0 7 FEV1 FEV6 lt 0 70 and FEV1 TE OREN gt 80 Pred lt 80 op pounealy Stage Il FEV1 FEV6 lt 0 70 and FEV1 lt 80 Pred lt 50 pene a E FEV1 FEV6 lt 0 70 and FEV1 lt 50 Pred lt 30 Bottom boundary T Sage 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 1 Turn the device on 2 When the TP icon appears press and hold the 4 and A buttons for approximately 3 seconds 3 The top 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 4 Press to set the top boundary value Page 10 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 5 The middle boundary can now be s
14. of 1 If the button is kept depressed the values will scroll faster Press the lt button to set the age 3 The height can now be set fh This is done by pressing the A or Y 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 4 button to set the height Note if height values are set below 100 the device assumes height is in inches and that Weight will be in lbs 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 Page 6 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 S Female Press the 4 button to set the gender After gender is selected the Vitalograph copd 6 USB will go to Test Mode where the Blow Icon is showing On some variants an additional data field comes first see below 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 Example Population Group NHANES III Caucasian C NHANES III African American AA NHANES III Hispanic American HA Performing the Test 1 2 The subject should sit down when blowing into the device unless advised otherwise In
15. or a cough detected in the first second FEV substituted for When FET lt 3s and abrupt end of test FEV6 Auto power down time Set to 2 minutes as standard Communications USB CE NOTICE Marking by the symbol CE indicates compliance of the Vitalograph 0086 4000 Respiratory Monitor copd 6 device to the Medical Devices Directive of the European Community Such marking is indicative that the Vitalograph 4000 Respiratory Monitor copd 6 device meets or exceeds the following technical standards Page 16 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Guidance and manufacturer s declaration electromagnetic emissions The 4000 Respiratory Monitor copd 6 is intended for use in the electromagnetic environment specified below The customer or the user of 4000 Respiratory Monitor copd 6 should assure that it is used in such an environment Compliance Electromagnetic environment guidance Compliance _ Group 1 The 4000 Respiratory Monitor 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 4000 Respiratory Monitor copd 6 is suitable for use in all establishments including Harmonic emissions Class A domestic establishments and those directly IEC 61000 3 2 Class A Fonnected to the public low voltage power t k that lies buildings used for Voltage fluctuations ee supplies buildings u
16. ows 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 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 E button has been pressed Pressing E again will toggle between best and last blow Pressing the A button will show the FEV6 and FEV6 Predicted results Pressing the A button again will show the FEV1 FEV6 and FEV1 FEV6 Predicted results Press the A button for a final time will show the estimated Lung As Age P Page 8 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 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 If the test subject experiences side effe
17. ser 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 attempt 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
18. sert a new disposable Safeway mouthpiece into the device Turn the device on if not already ON When the device is ready for a test the blow icon shows Gh 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 lightly and seal your lips firmly around it like this will demonstrate c Blow out as HARD and FAST as you can like this until I tell you to stop the unit will beep at end of test after 6 seconds Page 7 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 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 ii Any one of the blue zones I II Il or IV are not normal This subject should be referred for spirometry b The Obstructive Index Ol sh
19. ticles in the measuring device Page 11 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 Monthly Procedures 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 usage and test environment but it should be at least monthly or every 100 subjects 300 blows Annual Procedures 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 a ed el Eee Disinfect rossine Disinfectants mouthpiece ABS single use or BVF use ae a oe bee with a 70 ae ee bees alcohol Fascia adi hail impregnated cloth provides a suitable form of cleaning and
20. y 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 copd 6 USB User Manual P N 07409 Issue 2 EXPLANATION OF SYMBOLS Device symbols ps4 A O 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 Attention reference relevant section in manual USB connector User Interface Symbols e Yo kglb wa i f 5 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 Unit of weight measurement Lung Age Symbol Age Symbol Height Symbol Page 15 of 22 DT_0006 6 Vitalograph copd 6 USB User Manual P N 07409 Issue 2 TECHNICAL SPECIFICATIONS Material PC ABS Accuracy Better than 3 FEV1 amp FEV6 3 PEF Flow Impedance Beiter than 0 15kPa L s at 14L s Measurement Range FEV1 0 9 99 LBTPS FEV6 0 9 99 L BTPS Performance And Safety ATS ERS Guidelines 2005 Standards 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
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