Vitalograph 4500 Manual

Vitalograph 4500 Manual

Aim (aerosol inhalation monitor)
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8/3/2018
07608_2
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AIM
(Aerosol Inhalation Monitor)
Model 4500
User Training Manual
https://vitalograph.com/downloads/display/41
1/17

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Summary of Contents for Vitalograph 4500

  • Page 1 8/3/2018 07608_2 Select Language ▼ (Aerosol Inhalation Monitor) Model 4500 User Training Manual https://vitalograph.com/downloads/display/41 1/17...
  • Page 2 Vitalograph (Irl.) Ltd. Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: sales@vitalograph.ie www.vitalograph.ie © Copyright Vitalograph 2013 Current Edition (Issue 2) Cat. No. 07608 is a registered trademark https://vitalograph.com/downloads/display/41 2/17...
  • Page 3: Table Of Contents

    07608_2 Table of Contents 1. DESCRIPTION OF THE VITALOGRAPH AIM 2. FEATURES OF THE VITALOGRAPH AIM 3. GETTING THE VITALOGRAPH AIM READY FOR USE 4. POWER MANAGEMENT IN THE VITALOGRAPH AIM 5. OPERATING THE VITALOGRAPH AIM 6. CLEANING INSTRUCTIONS 1. CLEANING AND DISINFECTING THE VITALOGRAPH AIM 7.
  • 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. Figure 1: Components of the AIM https://vitalograph.com/downloads/display/41...
  • Page 5: Features Of The Vitalograph Aim

    Clear sounds for audio feedback Device guides the user through use 3. GETTING THE VITALOGRAPH AIM READY FOR USE 1. Remove the battery door from the rear of the unit. Fit four AAA 1.5V batteries, and replace the battery door.
  • Page 6: Power Management In The Vitalograph Aim

    8/3/2018 07608_2 4. 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.
  • Page 7 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. Figure 3: Results lights https://vitalograph.com/downloads/display/41 7/17...
  • Page 8: Cleaning Instructions

    Figure 6: Spacer Simulator Technique Summary 6. CLEANING INSTRUCTIONS 6.1 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.
  • Page 9: Fault Finding Guide

    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 10: 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 11: Technical Specifications

    Attention(reference relevant section in manual) The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. 11. TECHNICAL SPECIFICATIONS Product Vitalograph 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...
  • Page 12: Ce Notice

    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 –...
  • Page 13 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. IEC 60601 Test level...
  • Page 14 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...
  • Page 15: Fda Notice

    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.
  • Page 16: Declaration Of Conformity

    14. DECLARATION OF CONFORMITY Product: Vitalograph Model 4500 AIM 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, as amended.
  • Page 17: 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.

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