Vitalograph Aim 4500, User Manual

Page 1: ...AIM User Manual 07608 Issue 1 Copyright Vitalograph 2011 DT_0006 8 Vitalograph Vitalograph Vitalograph Vitalograph AIM Aerosol Inhalation Monitor MODEL 4500 User Manual l ...

Page 2: ...hone 040 54 73 91 0 Fax 040 547 391 40 e mail info vitalograph de Vitalograph Inc 13310 West 99th Street Lenexa Kansas 66215 U S A Phone 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com Vitalograph Irl Ltd Gort Road Business Park Ennis Co Clare Ireland Phone 065 6864100 Fax 065 6829289 e mail sales vitalograph ie Internet www vitalograph com Copyright Vitalograph 2011 Current Edition Iss...

Page 3: ...ITALOGRAPH AIM READY FOR USE 4 POWER MANAGEMENT IN THE VITALOGRAPH AIM 4 OPERATING THE VITALOGRAPH AIM 4 CLEANING INSTRUCTIONS 8 CLEANING AND DISINFECTING THE VITALOGRAPH AIM 8 FAULT FINDING GUIDE 9 CUSTOMER SERVICE 10 CONSUMABLES AND ACCESSORIES 10 EXPLANATION OF SYMBOLS 10 TECHNICAL SPECIFICATIONS 11 CE NOTICE 12 FDA NOTICE 17 DECLARATION OF CONFORMITY 18 GUARANTEE 19 ...

Page 4: ...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 Figure 1 Components of the AIM AIM Device Single use disposable DPI inhaler simulator Single use disposable MDI inhaler simulator also required for spacer Silicone Tubing User Int...

Page 5: ...of inspiration Timing of firing of MDI inhaler simulator Inspiratory flow rate throughout inspiration Inhalation time within target flow range Breath hold time at the end of inhalation Identifies and qualifies poor inhaler technique Power button DPI simulator button MDI simulator button Spacer simulator button Ready to inhale Flow lights Canister Activation MDI Inhalation time lights Breath hold l...

Page 6: ...le 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 2 If an MDI inh...

Page 7: ...t 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 ...

Page 8: ...on 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 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 a...

Page 9: ...AIM User Manual 07608 Issue A Copyright Vitalograph 2011 DT_0006 8 7 Figure 4 DPI Simulator Technique Summary Figure 5 MDI Simulator Technique Summary Figure 6 Spacer Simulator Technique Summary ...

Page 10: ... Overlay label PET Film Clean No White Silicone Tubing Silicone Clean Viable 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 Note Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals All external parts of...

Page 11: ...et If any of the rubber feet are damaged or missing replace all rubber feet Problem Fault Symptoms No flow measurements Possible Causes In probable order 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 Cannot read user interface Lights not coming on Possible Causes In probable ord...

Page 12: ...ically 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 EXPLAN...

Page 13: ...I 0 49 cmH2O L min at 50 L min MDI 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 40ºC Safety standards EN ISO 60601 2006 IEC 60601 1 2005 QA GMP standards EN ISO 13485 2003 CMDR...

Page 14: ...4500 AIM should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Model 4500 AIM 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 CISPR 11 Class B Harmonic emissions IEC 61000 3 2 B...

Page 15: ...rostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2kV for power supply lines 1 kV for input output lines Battery Operated Surge IEC 61000 4 5 1kV differential mode 2 kV common mode Batte...

Page 16: ...ic 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...

Page 17: ...d 2 3 P 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 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 equi...

Page 18: ...1 2 P 800 MHz to 2 5GHz 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 in watts w ...

Page 19: ...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 t...

Page 20: ...ction per Annex IX of the MDD also meets the provisions of the Essential Requirements Annex I via compliance with Annex II 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 ...

Page 21: ...od 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 ...