Vitalograph Aim 4500 User manual

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

AIM User Manual
07608
Issue 1
Copyright Vitalograph 2011 DT_0006-8
Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England
Phone: [phone] Fax: [phone]
e-mail: [e-mail]
Vitalograph GmbH, Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: [phone] Fax: [phone]
e-mail: [e-mail]
Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Phone: [phone] Fax: [phone]
e-mail: [e-mail]
Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: [phone] Fax: [phone]
e-mail: [e-mail]
Internet: www.vitalograph.com
© Copyright Vitalograph 2011
Current Edition (Issue 1)
Cat. No. 07608
Vitalograph is a registered trademark

AIM User Manual
07608
Issue 1
Copyright Vitalograph 2011 DT_0006-8
i
Table of Contents
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 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

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
2
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
AIM Device
Single-
use disposable
DPI inhaler simulator
Single-use disposable MDI
inhaler simulator.
(also required for spacer)
Silicone Tubing
User Interface
MDI placebo canister
(re-use until empty)

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
3
Figure 2: Components of the AIM – User Interface
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
Power button
DPI simulator
button
MDI simulator
button
Spacer
simulator button
Ready to
inhale
Flow
lights
Canister
Activation
(MDI)
Inhalation
time lights
Breath-hold
lights
End of
breath-hold
button
Battery
low light
Inhaler technique
summary display

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
4
• Easy to use and hygienic.
• Disposable MDI and DPI inhaler simulator mouthpieces
• Clear sounds for audio feedback
• Device guides the user through use.
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.
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.
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.

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
5
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.
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.

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
6
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 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.
Figure 3: Results lights

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

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
8
CLEANING INSTRUCTIONS
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.
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
Bottom
Case
Exterior
AMS Clean No
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 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”.

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
9
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.
• 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

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
10
Symptoms: 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.
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.
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)
EXPLANATION OF SYMBOLS
Internally powered ME equipment
k
Type BF equipment
V
Voltage DC
h Attention (reference relevant section in
manual)
Manufacturer
Year of Manufacture

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
11
The device must be taken to separate
collection at the product end-of-life. Do not
dispose of these products as unsorted
municipal waste.
TECHNICAL SPECIFICATIONS
Product 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
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
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%

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
12
CE NOTICE
Marking by the symbol l 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. 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 - 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
Battery
Operated
Voltage
Fluctuations/Flicker
emissions
IEC61000-3-3
Battery
Operated
The Model 4500 AIM is suitable
for use in all establishments,
including domestic
establishments and those
directly connected to the public
low-voltage power supply
network that supplies buildings
used for domestic purposes.

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
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
Immunity test IEC 60601
Test level
Complian
ce
level
Electromagnetic
environment -
guidance
Electrostatic
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
Battery
Operated
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % 100V
(>95% dip in
100V) for 0.5 cycle
40 % 100V
(60% dip in 100V)
for 5 cycles
70 % 100V
(30 % dip in 100V)
Battery
Operated

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
14
for 25 cycles
<5 % 100V
(>95 % dip in
100V) for 5 sec
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 Α/m
Not
Applicable
Power frequency
magnetic fields
should be at
levels
characteristic of a
typical location in
typical
commercial or
hospital
environment.
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
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 of the system,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended
separation distance

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
15
RF. IEC
61000-4-6
Radiated
RF. IEC
61000-4-3
150 kHz to
80 MHz in
ISM bands
3 V/m
80 MHz to
2.5 GHz
operated
3V/m from
80MHz top
2.5GHz
d = 1.2√P
d = 1.2√P…80MHz to 800
MHz
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 equipment
marked with the following
symbol:

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
16
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
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the Model 4500 AIM as recommended below,
according to the maximum output power of the communications
equipment.
Separation distance according to frequency of
transmitter
m
Rated maximum
output power of
transmitter
W 150 kHz to 80
MHz
d = 1.2√P
80 MHz to 800
MHz
d = 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)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
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

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
17
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.
FDA NOTICE
Caution: Federal law restricts this device to sale by, or on the order of
the physician.

AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
18
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
Certificate Nos. CE 00772, CE 85553, MD 82182, FM 83550
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director