AIM Aerosol Inhalation Monitor

Model 4500

User Manual

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110	Fax: (01280) 823302
e-mail: sales@vitalograph.co.uk
Vitalograph GmbH, Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: (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 (Issue 1)
Cat. No. 07618

is a registered trademark

Table of Contents

1. DESCRIPTION OF THE VITALOGRAPH AIM

2. MAIN COMPONENTS OF THE VITALOGRAPH AIM

3. FEATURES OF THE VITALOGRAPH AIM

4. GETTING THE VITALOGRAPH AIM READY FOR USE

5. POWER MANAGEMENT IN THE VITALOGRAPH AIM

6. OPERATING THE VITALOGRAPH AIM

7. CLEANING INSTRUCTIONS

8. FAULT FINDING GUIDE

9. CUSTOMER SERVICE

10. CONSUMABLES AND ACCESSORIES

11. EXPLANATION OF SYMBOLS

12. TECHNICAL SPECIFICATIONS

13. CE NOTICE

14. FDA NOTICE

15. DECLARATION OF CONFORMITY

16. GUARANTEE

1. 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.

2. Main Components of the VitalograpH AIM

3. 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 range
• Breath hold time at the end of inhalation
• Identifies and qualifies poor inhaler technique
• Easy to use and hygienic
• Disposable MDI and DPI inhaler simulator mouthpieces
• Clear sounds for audio feedback 
• Device guides the user through use

4. GETTING THE 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.
2. Attach the dual silicone tubing (see Figure 1), to the port on the side of the AIM.

5. 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.

6. 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 inhaler simulator mouthpiece is being used insert the placebo.
   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.
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:
   1. DPI Simulator
      1. Instruct the subject to take a forceful deep breath in until their lungs are full. The flow lights will light up.
      2. The aim is to get the flow indicator into the green zone as quickly as possible, but not to inhale too fast.
      3. The subject should continue to inhale until their lungs are full. The inhalation time lights will light up one second at a time.
      4. 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.
      5. When the subject ceases breath hold, press the end of breath-hold button.
   2. MDI Simulator
      1. 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.
      2. 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.
      3. 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.
      4. 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.
      5. When the subject ceases breath hold, press the end of breath-hold button.
   3. Spacer Simulator
      Note: The MDI inhaler simulator mouthpiece is used to simulate the spacer. Do not attach a spacer.
      1. Instruct the subject to press the canister just before or as inhalation starts. The canister activation lights will light up.
      2. The Spacer Simulator allows the subject to take a single or multiple breaths.
      3. The subject should continue until at least 3 seconds inhalation is achieved. The inhalation time lights will light up one second at a time.
      4. 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.
      5. 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.

CLEANING INSTRUCTIONS

7.1. Cleaning and Disinfecting the Vitalograph AIM

A new disposable inhaler simulator should be used for each subject.

Table of Materials Used & Cleaning/Disinfection Methods

This listing of materials used is given to provide users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.

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”.

8. Fault Finding Guide

9. 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.

10. Consumables and Accessories

11. Explanation of Symbols

	Internally powered ME equipment
	Type BF equipment
	Voltage DC
	Attention
	Manufacturer
	Year of Manufacture
	The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste.

12. Technical Specifications

13. 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:

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,

Portable and mobile RF communications equipment can affect medical electrical equipment.

14. FDA Notice

Caution: Federal law restricts this device to sale by, or on the order of the physician.

15. 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.

This device is classified as 1 with a measuring function 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 purposes.

Certifying Body: British Standards Institute {BSI}.
{For 93/42/EEC and CMDR}.

BSI Notified Body #: 0086

Signed on behalf of Vitalograph (Ireland) Ltd.

B. R. Garbe.

Group Managing Director

16. 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 within 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 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.