User Manual l
Contents
1. ISO 60601 2006 IEC 60601 1 2005 QA GMP standards EN ISO 13485 2003 CMDR SOR 98 282 amp FDA 21 CFR 820 Size 165 mm x 133 mm x 39 6 mm Weight 260g including batteries and tubing Storage Temperature 0 50 C Storage Relative Humidity 10 95 Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A CE NOTICE Marking by the symbol ce indicates compliance of the Vitalograph AIM to the Medical Devices Directive of the European Community Such marking is indicative that the Vitalograph AIM meets or exceeds the following technical standards Guidance and manufacturer s declaration electromagnetic emissions The Model 4500 AIM is intended for use in the electromagnetic environment specified below The customer or the user of the Model 4500 AIM should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Model 4500 AIM uses RF CISPR 11 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 Model 4500 AIM is suitable CISPR 11 for use in all establishments Harmonic emissions Battery including domestic IEC 61000 3 2 Operated establishments and those Voltage Battery directly connected to the public Fluctuations Flicker Operated low voltage power supply2. emissions network that supplies buildings IEC61000 3 3 used for domestic purposes Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A Guidance and manufacturer s declaration electromagnetic immunity The Model 4500 AIM is intended for use in the electromagnetic environment specified below The customer or the user of the Model 4500 AIM should assure that it is used in such an environment Immunity test IEC 60601 Complian Electromagnetic Test level ce environment level guidance Electrostatic 6 kV contact 6 kV Floors should be discharge contact wood concrete or ESD 8 kV air 8 kV air ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for power Battery transient burst supply lines Operated 1 kV for IEC 61000 4 4 input output lines Surge 1kV differential Battery IEC 61000 4 5 mode Operated 2 kV common mode Voltage dips lt 5 100V Battery short gt 95 dip in Operated interruptions 100V for 0 5 cycle and voltage variations on 40 100V power supply 60 dip in 100V input lines for 5 cycles IEC 61000 4 11 70 100V 30 dip in 100V Copyright Vitalograph 2011 13 DT_0006 8 AIM User Manual 07608 Issue A gt 95 for 25 cycles lt 5 100V dip in 100V for 5 sec Power frequency 50 60 magnetic field IEC
3. the assessment of other cleaning and disinfecting procedures available in the facility on this device Part Material Clean Autoclave Recommended Disinfect Disinfectants Top Clean No Wiping with a 70 isopropyl alcohol Case impregnated cloth provides a suitable Exterior form of cleaning and low level Bottom Clean No disinfection This may be preceded by Case cleaning with an anti static foam Exterior cleaner if necessary label White Silicone Clean Viable Silicone I Note Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals All external parts of the Vitalograph AIM require cleaning i e the removal of visible particulate contamination The AIM is not designed as a sterile device 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 Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A FAULT FINDING GUIDE Problem Fault Symptoms eTest begins automatically elnhalation time accumulates without the subject inhaling automatically Possible Causes In probable order eFlowhead and or tubing not stationary
4. 06 8 AIM User Manual 07608 Issue A 5 Instruct the subject to position the inhaler simulator between the lips sealed around the mouthpiece Note Ensure that the holes adjacent to the tubing connection to the inhaler simulator are not obstructed 6 Depending on the inhaler simulator option selected the following instructions should be followed a DPI Simulator i Instruct the subject to take a forceful deep breath in until their lungs are full The flow lights will light up ii The aim is to get the flow indicator into the green zone as quickly as possible but not to inhale too fast iii The subject should continue to inhale until their lungs are full The inhalation time lights will light up one second at a time iv The subject should hold their breath for as long as comfortable at least 3 seconds The breath hold lights will light up one second at a time v When the subject ceases breath hold press the end of breath hold button b MDI Simulator i Instruct the subject to take a slow deep breath and simultaneously press the placebo canister The flow lights and the canister activation lights will light up ii The aim is to press the canister as the subject starts to inhale and to continue to inhale for as long as possible but not too fast iii The subject should continue to inhale until their lungs are full at least 3 seconds The inhalation time lights will light up one second at a time iv The subject sh
5. 61000 4 8 3 A m Hz Not Power frequency Applicable magnetic fields should be at levels characteristic of a typical location in typical commercial or hospital environment Guidance and manufacturer s declaration electromagnetic immunity The Model 4500 AIM is intended for use in the electromagnetic environment specified below The customer or the user of the Model 4500 AIM should assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Conducted 3 Vrms Battery Portable and mobile RF communications equipment should be used no closer to any part of the system including cables than the recommended _ separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Copyright Vitalograph 2011 14 DT_0006 8 AIM User Manual 07608 Issue A RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 150 kHz to 80 MHz in ISM bands 3 V m 80 MHz to 2 5 GHz operated 3V m 80MHz 2 5GHz from top d 1 24P d 1 2VP 80MHz to 800 MHz d 2 3VP 800 MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF
6. 8 Issue 1 10 10 10 11 12 17 18 19 DT_0006 8 AIM User Manual 07608 Issue A DESCRIPTION OF THE VITALOGRAPH AIM The device Aerosol Inhalation Monitor is designed to enable a medical professional to objectively assess in detail how the test subject uses their inhaler This detailed knowledge allows the medical professional to assess and coach the test subject in perfecting their inhalation technique The main components for the Vitalograph AIM are shown in Figures 1 and 2 Single use disposable MDI placebo canister DPI inhaler simulator re use until empty User Interface Single use disposable MDI inhaler simulator also required for spacer Figure 1 Components of the AIM Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A MDI simulator Spacer DPI simulator button simulator button button Power button ns Inhaler technique Ready to O s summary display inhale Flow lights Canister Activation MDI Battery low light End of Inhalation Breath hold breath hold time lights lights button Figure 2 Components of the AIM User Interface FEATURES OF THE VITALOGRAPH AIM The Vitalograph AIM features include Assists in training patients to use their inhalers properly Inspiratory acceleration at the start of inspiration Timing of firing of MDI inhaler simulator Inspiratory flow rate throughout inspiration Inhalation time within target flow ra
7. AIM User Manual 07608 Issue 1 jfitalograph AIM Aerosol Inhalation Monitor MODEL 4500 User Manual Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue 1 Vitalograph Ltd Maids Moreton Buckingham MK18 1SW England Phone 01280 827110 Fax 01280 823302 e mail sales vitalograph co uk Vitalograph GmbH Rellinger StraBe 64a 20257 Hamburg Germany Phone 040 54 73 91 0 Fax 040 547 391 40 e mail info vitalograph de Vitalograph Inc 13310 West 99 Street Lenexa Kansas 66215 U S A Phone 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com al Vitalograph Irl Ltd Gort Road Business Park Ennis Co Clare lreland Phone 065 6864100 Fax 065 6829289 e mail sales vitalograph ie Internet www vitalograph com Copyright Vitalograph 2011 Current Edition Issue 1 Cat No 07608 fitalograph is a registered trademark Copyright Vitalograph 2011 DT_0006 8 Table of Contents DESCRIPTION OF THE VITALOGRAPH AIM FEATURES OF THE VITALOGRAPH AIM GETTING THE VITALOGRAPH AIM READY FOR USE POWER MANAGEMENT IN THE VITALOGRAPH AIM OPERATING THE VITALOGRAPH AIM CLEANING INSTRUCTIONS CLEANING AND DISINFECTING THE VITALOGRAPH AIM FAULT FINDING GUIDE CUSTOMER SERVICE CONSUMABLES AND ACCESSORIES EXPLANATION OF SYMBOLS TECHNICAL SPECIFICATIONS CE NOTICE FDA NOTICE DECLARATION OF CONFORMITY GUARANTEE Copyright Vitalograph 2011 AIM User Manual 0760
8. at the start of test Hold them steady until the Blow Icon appears ePress the DPI MDI or Spacer simulator button Problem Fault Symptoms e Rocking device Possible Causes In probable order e Check for damaged or missing rubber feet elf any of the rubber feet are damaged or missing replace all rubber feet Problem Fault Symptoms e No flow measurements Possible Causes In probable order e Ensure that the silicone tubing is not pinched or trapped Ensure that the silicone tubing is fitted to the AIM device and the inhaler simulator Problem Fault Symptoms e Cannot read user interface e Lights not coming on Possible Causes In probable order e The battery may be low Replace the batteries e Main PCB failure contact support Problem Fault Symptoms e MDI simulator activation light not coming on Possible Causes In probable order e Placebo canister is not fitted e Placebo canister is empty Problem Fault e Flow measurement appears low for the MDI Copyright Vitalograph 2011 DT_0006 8 9 AIM User Manual 07608 Issue A Symptoms simulator Possible Causes e Placebo canister needs to be fitted If a placebo In probable is not fitted then flow measurements will not be order correct CUSTOMER SERVICE Service and repairs should be carried out only by the manufacturer the approved im
9. hold less than 3 seconds Breath hold greater than 3 Figure 3 Results ighis Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A DPI Simulator Technique Good Poor Summary Fail Red nspiratory flow rate was too low or too slov Sub optimal Orange al OIG TOO SNOM O spiratory Tmo ot Torcerul enoug Good Green OILEIL ala UC ececuale Sb Figure 4 DPI Simulator Technique Summary MDI Simulator Technique Good Poor Summary Fail Red Fail Red nspiratory flow rate was too fast Sub optimal Orange halation time and or breath hold too short Good Green Figure 5 MDI Simulator Technique Summary Spacer Simulator Technique Good Poor Summary Fail Red Fail Red _ Inspiratory flow rate was too fast Sub optimal Orange Inhalation time and or breath hold too short Good Green rect Canister activation v acequa Figure 6 Spacer Simulator Technique Summary Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A CLEANING INSTRUCTIONS Cleaning and Disinfecting the Vitalograph AIM A new disposable inhaler simulator should be used for each subject The frequency of cleaning and disinfecting is dependent on the Facility s Risk Assessment usage and test environment Table of Materials Used amp Cleaning Disinfection Methods This listing of materials used is given to provide users with information to allow
10. is user manual is designed and manufactured in accordance with the following QMS regulations and standards European Medical Devices Directive MDD 93 42 EEC as amended This device is classified as 1 with a measuring function per Annex IX of the MDD also meets the provisions of 0086 the Essential Requirements Annex via compliance with Annex Il of the Medical Devices Directive as per Article 11 section 3a excluding point 4 of Annex II Canadian Medical Device Regulation CMDR SOR 98 282 FDA Quality System Regulation QSR 21 CFR 820 EN ISO 13485 2003 Medical devices Quality management systems Requirements for regulatory purposes Certifying Body British Standards Institute BSI For 93 42 EEC and CMDR BSI Notified Body 0086 Certificate Nos CE 00772 CE 85553 MD 82182 FM 83550 Signed on behalf of Vitalograph Ireland Ltd B R Garbe Group Managing Director Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A GUARANTEE Subject to the conditions listed below Vitalograph Ltd and its associated companies hereinafter called the Company guarantee to repair or at its option 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 wi
11. 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 EEE 2011 DT_0006 8
12. n 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 Copyright Vitalograph 2011 DT_0006 8 16 AIM User Manual 07608 Issue A 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 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 the physician Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A DECLARATION OF CONFORMITY Product Vitalograph Model 4500 AIM Vitalograph hereby ensures and declares that the above product associated with th
13. nge Breath hold time at the end of inhalation Identifies and qualifies poor inhaler technique Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A Easy to use and hygienic Disposable MDI and DPI inhaler simulator mouthpieces Clear sounds for audio feedback Device guides the user through use GETTING THE VITALOGRAPH AIM READY FOR USE 1 2 Remove the battery door from the rear of the unit Fit four AAA 1 5V batteries and replace the battery door Attach the dual silicone tubing see Figure 1 to the port on the side of the AIM POWER MANAGEMENT IN THE VITALOGRAPH AIM The AIM operates with 4 AAA 1 5V disposable batteries If the battery light See Figure 2 comes on the batteries need to be replaced Replace the batteries by removing the battery door on the underside of the device Note Dispose of used batteries safely OPERATING THE VITALOGRAPH AIM 1 Connect a new MDI or DPI inhaler simulator mouthpiece to the device via the silicone tubing Note The inhaler simulators are single patient use If an MDI inhaler simulator mouthpiece is being used insert the placebo Note If a placebo is not fitted then flow measurements will not be correct Press the power button and select the inhaler simulator option DPI simulator MDI simulator Spacer simulator Instruct the test subject to breath fully out but not through the inhaler simulator Copyright Vitalograph 2011 DT_00
14. ould hold their breath for as long as comfortable at least 3 seconds The breath hold lights will light up one second at a time v When the subject ceases breath hold press the end of breath hold button Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A c Spacer Simulator Note The MDI inhaler simulator mouthpiece is used to simulate the spacer Do not attach a spacer v Instruct the subject to press the canister just before or as inhalation starts The canister activation lights will light up The Spacer Simulator allows the subject to take a single or multiple breaths The subject should continue until at least 3 seconds inhalation is achieved The inhalation time lights will light up one second at a time The subject should hold their breath for as long as comfortable at least 3 seconds The breath hold lights will light up one second at a time When the subject ceases breath hold press the end of breath hold button 7 The individual results lights see Figure 3 and Technique Good Poor summary see Figure 4 6 will then appear 8 To repeat press the appropriate inhaler simulator option button Note The operating instructions and results shown are for the generic AIM device Some variants will have different operating instructions and results Please refer to the individual Quick Start Guide for these variants Inhale time less than 3 seconds Flow rate too low Breath
15. porter or by Service Agents specifically approved by Vitalograph For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops please refer to the contact information at the start of this manual CONSUMABLES AND ACCESSORIES Cat no Description 45610 Disposable DPI Inhaler Simulator 25 45611 Disposable MDI Inhaler Simulator 25 79192 Replacement silicone tubing 45027 HFA Placebo Aerosol 8 EXPLANATION OF SYMBOLS Internally powered ME equipment Type BF equipment y Voltage DC A Attention reference relevant section in manual ud Manufacturer er Year of Manufacture Copyright Vitalograph 2011 DT_0006 8 municipal waste TECHNICAL SPECIFICATIONS AIM User Manual 07608 Issue A collection at the product end of life Do not et The device must be taken to separate dispose of these products as unsorted Product AIM Model 4500 Flow detection principle Differential pressure sensor Flow impedance of inhaler simulator mouthpiece DPI 0 49 cmH2O L min at 50 L min MDI amp Spacer 0 016 cmH2O L min at 50 L min Flow detection Flow sampling 20Hz Maximum flow 100 L min Flow accuracy when operated in operating temperature range conditions Better than 5 or 5L min Power Supply 4 x AAA 1 5V batteries Operating temperature range Design limits 10 40 C Safety standards EN
16. thin 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 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 it was purchased for advice The Company does not authorize 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
17. 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 Ko Copyright Vitalograph 2011 DT_0006 8 AIM User Manual 07608 Issue A Recommended separation distances between portable and mobile RF communication equipment and the Model 4500 AIM The Model 4500 AIM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Model 4500 AIM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Model 4500 AIM 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 transmitter m 150 kHz to 80 80 MHz to 800 800 MHz to Ww MHz MHz 2 5GHz d 1 2 P d 1 2VP d 2 3 P 0 01 0 1m 0 1m 0 2m 0 1 0 4m 0 4m 0 7m 1 1 2m 1 2m 2 3m 10 3 7m 3 7m 7 4m 100 11 7m 11 7m 23 3m 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 i
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