Vitalograph 4500 Manuale utente
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AIM
(Aerosol Inhalation Monitor)
Model 4500
User Training Manual
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UK Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110
Fax: (01280) 823302
e-mail: [email protected]
www.vitalograph.co.uk
Export Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: +44 1280 827120
Fax: +44 1280 823302
e-mail: [email protected]
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: (040) 54 73 91-0
Fax: (040) 547 391 40
e-mail: [email protected]
www.vitalograph.de
Vitalograph Inc.
13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Phone: (913) 730-3200
Fax: (913) 730-3232
e-mail: [email protected]
www.vitalograph.com
Vitalograph (Irl.) Ltd.
Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6864100
Fax: (065) 6829289
e-mail: [email protected]
www.vitalograph.ie
© Copyright Vitalograph 2013
Current Edition (Issue 2)
Cat. No. 07608
is a registered trademark
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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. FAULT FINDING GUIDE
8. CUSTOMER SERVICE
9. CONSUMABLES AND ACCESSORIES
10. EXPLANATION OF SYMBOLS
11. TECHNICAL SPECIFICATIONS
12. CE NOTICE
13. FDA NOTICE
14. DECLARATION OF CONFORMITY
15. GUARANTEE
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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.
The main components for the Vitalograph AIM are shown in Figures 1 and 2.
Figure 1: Components of the AIM
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Figure 2: Components of the AIM – User Interface
2. 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
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.
2. Attach the dual silicone tubing (see Figure 1), to the port on the side of the AIM.
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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.
Note: Dispose of used batteries safely.
5. 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:
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.
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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 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.
c. Spacer Simulator
Note: The MDI inhaler simulator mouthpiece is used to simulate the spacer. Do not attach a
spacer.
i. Instruct the subject to press the canister just before or as inhalation starts. The
canister activation lights will light up.
ii. The Spacer Simulator allows the subject to take a single or multiple breaths.
iii. The subject should continue until at least 3 seconds inhalation is achieved. 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.
7. The individual results lights (see Figure 3) and TechniqueGood/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.
Figure 3: Results lights
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Figure 4: DPI Simulator Technique Summary
Figure 5: MDI Simulator Technique Summary
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.
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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.
Part Material Clean/
Disinfect Autoclave Recommended Disinfectants
Top Case
Exterior ABS Clean No 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.
Bottom
Case
Exterior
AMS Clean No
Overlay
label PET Film Clean No
White
Silicone
Tubing
Silicone Clean Viable
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”.
7. FAULT FINDING GUIDE
Problem Fault
Symptoms: Test begins automatically
Inhalation time accumulates automatically without the subject inhaling
Possible Causes:
(In probable order) Flowhead and/or tubing not stationary at the start of test. Hold them
steady until the ‘Blow Icon’ appears
Press the DPI, MDI or Spacer simulator button
Problem Fault
Symptoms: Rocking device
Possible Causes:
(In probable order) Check for damaged or missing rubber feet
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
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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 order) The battery may be low. Replace the batteries
Main PCB failure – contact support
Problem Fault
Symptoms: MDI simulator activation light not coming on
Possible Causes:
(In probable order) Placebo canister is not fitted
Placebo canister is empty
Problem Fault
Symptoms: Flow measurement appears low for the MDI simulator
Possible Causes:
(In probable order) Placebo canister needs to be fitted. If a placebo is not fitted then flow
measurements will not be correct
8. 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.
9. 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)
10. EXPLANATION OF SYMBOLS
Internally powered ME equipment
Type BF equipment
Voltage DC
Indice
