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Summary of Contents for Vitalograph Aim 4500
- Page 1 AIM User Manual 07608 Issue 1 Vitalograph Vitalograph Vitalograph Vitalograph Aerosol Inhalation Monitor MODEL 4500 User Manual Copyright Vitalograph 2011 DT_0006-8...
- Page 2 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 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 (Issue 1) Cat.
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Page 3: Table Of Contents
AIM User Manual 07608 Issue 1 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 LEANING AND ISINFECTING THE... -
Page 4: Description Of The Vitalograph Aim
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... -
Page 5: Features Of The Vitalograph Aim
Figure 2: Components of the AIM – User Interface EATURES OF THE ITALOGRAPH The Vitalograph AIM features include: • Assists in training patients to use their inhalers properly • Inspiratory acceleration at the start of inspiration •... -
Page 6: Getting The Vitalograph Aim Ready For Use
Note: If a placebo is not fitted then flow measurements will not be correct. 3. Press the power button and select the inhaler simulator option DPI simulator MDI simulator Spacer simulator 4. Instruct the test subject to breath fully out, but not through the inhaler simulator. Copyright Vitalograph 2011 DT_0006-8... - Page 7 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. Copyright Vitalograph 2011 DT_0006-8...
- Page 8 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. Figure 3: Results lights Copyright Vitalograph 2011 DT_0006-8...
- Page 9 AIM User Manual 07608 Issue A Figure 4: DPI Simulator Technique Summary Figure 5: MDI Simulator Technique Summary Figure 6: Spacer Simulator Technique Summary Copyright Vitalograph 2011 DT_0006-8...
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Page 10: Cleaning Instructions
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. -
Page 11: Fault Finding Guide
• MDI simulator activation light not coming on. Problem Fault Symptoms: • Placebo canister is not fitted Possible Causes: • Placebo canister is empty (In probable order) • Flow measurement appears low for the MDI Problem Fault Symptoms: Copyright Vitalograph 2011 DT_0006-8... -
Page 12: Customer Service
Service and repairs should be carried out only by the manufacturer, the approved importer 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. -
Page 13: Technical Specifications
EN ISO 60601:2006 {IEC 60601 -1:2005} QA/GMP standards EN ISO 13485:2003, CMDR SOR/98-282 & FDA 21 CFR 820 Size 165 mm x 133 mm x 39.6 mm Weight 260g (including batteries and tubing) Storage Temperature 0–50ºC Storage Relative Humidity 10%–95% Copyright Vitalograph 2011 DT_0006-8... -
Page 14: Ce Notice
Marking by the symbol 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. - Page 15 Operated (>95% dip in interruptions 100V) for 0.5 cycle voltage variations 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 DT_0006-8...
- Page 16 Recommended separation distance Conducted 3 Vrms Battery Copyright Vitalograph 2011 DT_0006-8...
- Page 17 (m) Field strengths from fixed transmitters, determined 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: Copyright Vitalograph 2011 DT_0006-8...
- Page 18 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...
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Page 19: Fda Notice
EMC information provided, Portable and mobile RF communications equipment can affect medical electrical equipment. FDA N OTICE Caution: Federal law restricts this device to sale by, or on the order of the physician. Copyright Vitalograph 2011 DT_0006-8... -
Page 20: Declaration Of Conformity
Issue A ECLARATION OF ONFORMITY Vitalograph Model 4500 AIM Product 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... -
Page 21: Guarantee
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.
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