Vitalograph Asma-1 User manual

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Asma-1
Modelo 4000
Manual de treinamento do
usuário

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UK Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, Inglaterra
Telefone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.co.uk
Exportação de vendas
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, Inglaterra
Telefone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a, 20257 Hamburgo, Alemanha
Telefone: (040) 54 73 91-0
Fax: [phone]
e-mail: [email protected]
www.vitalograph.de
Vitalograph Inc.
13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Toll Free: 800 255 6626
Phone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.com
Vitalograph (Irl.) Ltd.
Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.ie
© Copyright Vitalograph 2013
Current Edition (Issue 9)
Cat. No. 07380
is a registered trademark

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Table of Contents
1. DESCRIPTION OF THE VITALOGRAPH ASMA-1
1. The Asthma Sufferer
2. MAIN COMPONENTS OF THE VITALOGRAPH ASMA-1
3. FEATURES OF THE VITALOGRAPH ASMA-1
4. GETTING THE VITALOGRAPH ASMA-1 READY FOR USE
5. POWER MANAGEMENT IN THE VITALOGRAPH ASMA-1
6. OPERATING THE VITALOGRAPH ASMA-1
1. SETTING PERSONAL BEST (REFERENCE) VALUES
2. SETTING MANAGEMENT ZONES
3. HOW TO USE THE VITALOGRAPH ASMA-1
4. REVIEWING PREVIOUS RESULTS
5. DELETING ALL RESULTS HISTORY
7. CLEANING INSTRUCTIONS
1. HOME USE CLEANING AND DISINFECTION OF THE VITALOGRAPH ASMA-1
2. CLEANING AND DISINFECTING THE VITALOGRAPH ASMA-1 IN CLINIC USE
1. Table of Materials Used & Cleaning/Disinfection Methods
2. Removing the Flowhead for Cleaning and Disinfecting
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

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1. DESCRIPTION OF THE VITALOGRAPH ASMA-1
The Vitalograph asma-1 is a medical device intended to give objective measures of lung function
for help in managing asthma. The device measures airflow out of the lungs when blown into as
hard and fast as possible. The Vitalograph asma-1 can reveal narrowing of the airways well in
advance of an asthma attack being felt by the asthmatic. Used mainly by persons with moderate to
severe and persistent asthma, the Vitalograph asma-1 can help determine:
when to seek emergency medical care.
the effectiveness of a person’s asthma management and treatment plan.
when to stop or add medication, as directed by the physician.
what triggers the asthma attack (such as exercise-induced asthma).
With asthma, sometimes the sufferer may feel their breathing is fine, but when the sufferer
measures it with the Vitalograph asma-1, lung function may be decreased. The Vitalograph asma-
1 can help the sufferer determine airway changes and better manage the asthma.
The primary healthcare professional needs to educate the sufferer in Self-Management of asthma.
This will start upon diagnosis and continue with all members of the healthcare team. The Action
Plan should be tailored to individual needs, but will include: basic facts about asthma; roles of
medication; skills required for devices and medication, environmental control measures; when and
how to take rescue actions.
1.1. The Asthma Sufferer
Most people with asthma need to monitor their asthma at least twice a day and to have a plan of
action to keep it under control. Although how the sufferer feels and what the sufferer can do is
important, PEF or FEV1 scores may accurately show how the breathing is changing. Modern
asthma medicines aim to give the sufferer the best possible score, keeping the sufferer in the
green zone. It is also important to aim for stable PEF/FEV1, i.e. little difference between morning
and evening scores and from day to day.
Many people over the ages of five will benefit from monitoring their asthma with the Vitalograph
asma-1, indicating when and how much to use their reliever medication. It will also help the doctor
because scores make it easier to see how well the asthma is controlled and when treatment needs
changing.
Only the doctor can determine the best Action Plan for the sufferer. This is likely to be preceded by
an initial assessment followed by a diagnostic phase. The Vitalograph asma-1 records many test
sessions for subsequent review by the healthcare professional. The Action Plan is then assessed
against the scores over several days. The treatment and/or Action Plan may be changed following
the diagnostic phase. This procedure may be repeated until the optimum Action Plan is proven.
The ‘Personal Best’ is the best PEF or FEV1 value that the sufferer can achieve - this is the ‘100%’
or ‘reference’ value. Population normative standards are not clinically useful in ongoing serial
monitoring of the asthma.
2. MAIN COMPONENTS OF THE VITALOGRAPH ASMA-1
A Keypad - Up, Down & Enter Button
B LCD
C Flowhead
On/Off Button
Down Button
Up Button
Enter Button

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3. FEATURES OF THE VITALOGRAPH ASMA-1
The Vitalograph asma-1 features include:
Electronic record – no need for record cards
Stores 600 test sessions
Automatically assesses test quality
Measures PEF and FEV1 and % of personal best
PEF and FEV1 zones can be personalized
Automatically stores best values
Easy to clean mouthpiece and flowhead
4. GETTING THE VITALOGRAPH ASMA-1 READY FOR USE
1. Remove the battery door from the rear of the unit. Fit two AAA 1.5V batteries, and replace
the battery door.
2. Insert the mouthpiece and turn on the device.
5. POWER MANAGEMENT IN THE VITALOGRAPH ASMA-1
The asma-1 operates with 2 AAA 1.5V disposable batteries. If the battery symbol flashes 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 ASMA-1
6.1. Setting Personal Best (Reference) Values
Personal Best (reference) values can be set for peak flow (PEF) and/or forced expiratory volume
after 1 second (FEV1).
To set the Personal Best (reference) PEF, follow these steps:
1. Turn the device on, .
2. When the device is ready for a test ( ), press the and buttons together for 3 seconds.
3. The reference PEF value can now be set. This is done by pressing the button and
releasing when the value is reached. Press the to roll back. The values will
increase/decrease in values of 10. If the button is kept depressed, the values will scroll
faster.
4. Press ENTER to keep this reference PEF value.
Press again to exit, or to set the Best Test (reference) FEV1:

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1. The reference FEV1 value is set by pressing the button and releasing when the value is
reached. Press the to roll back. The values will increase/decrease in values of 0.10. If the
button is kept depressed, the values will scroll faster.
2. Press ENTER to keep this reference FEV1 value. The device will return to the test
screen.
Note: to de-activate zones, set both the PEF and FEV1 reference values to 000/0.00.
6.2. Setting Management Zones
The Vitalograph asma-1 can be set for use with 3 or 4 zone management plans. The zone
percentages are factory set to 2 boundaries, 80% & 50%, i.e. 3 Zones (80-100%, 50-80%, 0-50%).
For 4 zones the middle boundary is set last. The colour systems for each zone type are as follows;
To set the boundary percentage values for 3 zones, follow these steps;
1. Turn the device on, .
2. When the device is ready for a test ( ), press the and buttons together for
approximately 3 seconds.
3. The top (Green/Yellow) boundary can now be set. This is done by pressing the or button
and releasing when the value is reached. The values will increase/decrease in values of 1%.
If the button is kept depressed, the values will scroll faster.
4. Press ENTER to set the top (Green/Yellow) boundary value.
5. The bottom (Yellow/Red) boundary can now be set. This is done by pressing the or
button and releasing when the value is reached. Press to set the bottom(Yellow/Red)
boundary value.
6. Only 2 boundaries are required for the 3 zone system, so the next value should be selected
as 0% (default). Press . The device will return to the test screen.
To set the boundary percentage values for 4 zones, follow these steps;
1. First, set the top and bottom boundaries – see above procedure (steps 1 - 6).
2. The middle (Yellow/Orange) boundary can now be set. This is done by pressing the button
and releasing when the middle boundary value is reached.The values will increase/decrease
in values of 1% after an initial jump to the lower boundary value. If the button is kept
depressed, the values will scroll faster. This boundary value cannot be set at a value that is
greater than the top boundary value or less than the bottom boundary value.
3. Press to set the middle (Yellow/Orange) boundary value. The device will return to the test
screen.

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6.3. How to Use the Vitalograph asma-1
1. Sit down when blowing into the device (unless the physician advises otherwise).
2. Turn the device on, with the mouthpiece inserted. (Use a disposable SafeTway
mouthpiece in clinic.)
3. When the device is ready for a test ( ), holding the head high, breathe in as deeply as
possible, hold the Vitalograph asma-1 ready in front of the mouth.
4. Holding the breath, place the mouthpiece into the mouth, biting the mouthpiece lightly, and
with the lips firmly sealed around it.
5. Blow out as HARD and as FAST as possible for a second or more. Be careful not to block
the mouthpiece with the tongue or teeth. A ‘spitting’ action will give false readings.
6. The PEF result for this blow will be displayed, followed by the FEV1 result after
approximately 3 seconds and an arrow will indicate which colour management zone this
relates to, if the Personal Best has been set.
7. With the blow icon showing, blow again ( ). Usually 3 blows are required.
8. To view the best test in the session (best PEF and best FEV1), press the button. This is
the value that is recorded for the session in the device history.
Note: if an exclamation mark ! appears, this means it was not a good quality blow and the subject
should blow again. ! appears when: The time to Peak Flow >120ms or a cough is detected in the
1st second.
If the subject experiences dizziness or fatigue during the test session, wait until this passes before
blowing again or terminate the session.
6.4. Reviewing Previous Results
The Vitalograph asma-1 can store up to 600 test sessions. In order to view previously performed
test sessions, follow these steps:
1. Turn the device on, .
2. When the device is ready for a test ( ), press the button for approximately 3 seconds.
3. The most recent test session will now be displayed. The best PEF result will be displayed for
approximately 3 seconds, followed by the best FEV1 result. The session number ‘1’ is also
displayed, this is the latest session.
4. Earlier test sessions can also be viewed. Pressing the button once will show ‘2’ the
previous test, and so on.
5. Press . The device will return to the test screen.
6.5. Deleting All Results History
Caution: Once the history has been deleted it cannot be recovered.
To delete the history entirely, i.e. all previously stored session results, follow these steps:
1. Turn the device on, .
2. When the device is ready for a test ( ), press the and buttons simultaneously for
approximately 10 seconds.

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3. A long beep will indicate success and the device will return to the test screen.
7. CLEANING INSTRUCTIONS
7.1. Home use cleaning and disinfection of the Vitalograph asma-1
The Vitalograph asma-1 should continue to give reliable measurements for up to three years in
home use. Then replace it with a new device.
Keep it clean and dust free. If you suspect the device is damaged or is measuring incorrectly,
contact the doctor immediately.
The mouthpiece is the only part of the device, which needs to be routinely cleaned in home use.
The outer surfaces should be thoroughly cleaned every week, more often if necessary. We
recommend the use of an ordinary alcohol wipe, paying special attention to the mouthpiece area.
Table of Materials Used & Cleaning/Disinfection Methods
Part Material Cleaning Recommendation Disinfection
Recommendation
Plastic
Mouthpieces ABS Wash in warm soapy water. Rinse in clean water Alcohol wipe (IPA 70- 90%)
Body ABS Wipe with a damp cloth Alcohol wipe (IPA 70-
90%)
Fascia PMMA/ PET Wipe with a damp cloth Alcohol wipe (IPA 70-
90%)
Buttons Synthetic
Rubber Wipe with a damp cloth Alcohol wipe (IPA 70- 90%)
7.2. Cleaning and Disinfecting the Vitalograph asma-1 In Clinic Use
A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5
minutes should be allowed between subjects to allow settling of previously aerosolized particles in
the measuring device.
It is recommended that the device be regularly cleaned according to the guidelines of the user’s
facility. The disinfection materials and procedures applied in the users’ facility may be more
appropriate than the methods outlined below.
In the event of visible contamination of the flowhead element, it should be cleaned or disinfected
as described in the accompanying table. The device should be replaced in the event of damage, or
if visibly contaminated.
The frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage,
and test environment, but it should be at least monthly or every 100 subjects (300 blows).
It is recommended that the device be replaced annually or test and calibration serviced at least
annually. There is no planned preventive maintenance for this medical device.
7.2.1. TABLE OF MATERIALS USED & CLEANING/DISINFECTION METHODS
This listing of materials used is given to provide clinical users with information to allow
the assessment of other cleaning and disinfecting procedures available in the facility
on this device.

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Part Material Clean/
Disinfect
Autoclave
Possible?
Recommended
Disinfectants
SafeTway
mouthpiece
or BVF
Cardboard/
ABS Dispose – single use No Dispose – single use
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.
Fascia PMMA/
PET Clean No
Removable
flowhead ABS, Stainless
Steel
Clean No Disinfect by immersion in
sodium dichloroisocyanurate
solution at 1000 ppm
concentration of free chlorine
for 15 minutes (see following
section for recommended
cleaning/disinfection method
for the flowhead)
Maximum of 50 cleaning
cycles allowed.
All external parts of the Vitalograph asma-1 require cleaning, i.e. the removal of
visible particulate contamination. The parts of the device that make up the flowhead,
which comes into contact with the breath of the subjects being tested, also require
disinfecting. This device is not designated 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.
7.2.2. REMOVING THE FLOWHEAD FOR CLEANING AND DISINFECTING

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Flowhead Disassembled Flowhead Assembled
1. Remove the flowhead from the body with a sharp pulling motion.
2. Clean the flowhead by washing in a mild detergent to remove particulate
contamination, taking care not to touch the moving vanes. Swill vigorously in
water with mild detergent. Do not attempt to “rub” or “scrub” in the area of the
vanes. Rinse with clean water.
3. Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm
concentration of free chlorine for 15 minutes. Prepare disinfectant solution as
directed in the manufacturer’s guidelines. Rinse with warm water for faster
drying.
4. Leave it to dry completely before reassembling. Drying the flowhead may
require placing it in a warm place overnight. A drying cabinet is ideal.
Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of
cleaning and low-level disinfection for the case exterior, display, screen surround and
keys. Repeat this at least weekly to prevent a build-up of grime from normal handling
and use. Always follow the safety guidelines given by the manufacturer of cleaning
and disinfectant chemicals or equipment.
Reassemble the flowhead by pushing back on until it ‘clicks’ into position. Ensure that
the flowhead is pushed fully home.
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"
8. FAULT FINDING GUIDE

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Problem Fault Symptoms: No flow measurements.
Possible Causes:
(In probable order) The battery may be low. Replace the batteries. The flowhead may be damaged. Check that the
rotating vane is spinning freely.
Problem Fault Symptoms: Cannot read user interface.
Possible Causes:
(In probable order) The battery may be low. Replace the batteries.
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
Cat. No Description
40168 Mouthpiece (20)
20242 SafeTway Mouthpieces (200)
20303 Disposable Noseclips (200)
20980 Mini SafeTway mouthpieces (50)
20991 Long SafeTway mouthpieces (130)
28350 BVF Bacterial/Viral Filters (50)
40167 Pouch Spare (x10)
11. EXPLANATION OF SYMBOLS

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Type BF equipment
Class II
Voltage DC
Attention (reference relevant section in manual)
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.
Other Labels
Battery status
Battery status Full
Battery status Half
Battery status Quarter
Battery status Empty (flashing)
Blow Now Symbol
! Bad Test Symbol (Slow start or Cough)
Memory 90% - 100% Full Icon
Flashes when memory reaches 100%
12. TECHNICAL SPECIFICATIONS

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Product Respiratory Monitor asma-1
Model 4000
Flow detection principle Stator/rotor
Back pressure Better than 0.15kPa/L/s at 14L/s
Measurement Range: PEF: 25 – 840 L/min BTPS
FEV1: 0 – 9.99 L BTPS
Maximum test duration 1 second
Accuracy when operated in operating temperature
range conditions Better than ± 3% (FEV1), ± 10% (PEF)
Power Supply 2 AAA batteries
Operating temperature range 17 – 37°C
Performance standards the Vitalograph asma-1 meets
or exceeds EN ISO 23747:2007 ATS/ERS Guidelines 2005
Electromagnetic immunity: IEC 61000-4-2, IEC 61000-4-3 (battery
operated)
Storage Temperature 0–50ºC
Storage Relative Humidity 10%–95%
Auto power down time 2 minutes
Note:
1. All values displayed by the Vitalograph asma-1 are expressed as BTPS values.
2. Take care not to block the mouthpiece with the tongue or teeth. A ‘spitting’ action or
coughing will give false readings.

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13. CE NOTICE
Marking by the symbol indicates compliance of the Vitalograph asma-1 to the Medical Devices
Directive of the European Community. Such marking is indicative that the Vitalograph asma-1
meets or exceeds the following technical standards:
Guidance and manufacturer’s declaration – electromagnetic emissions
The 4000 Respiratory Monitor asma-1 is intended for use in the electromagnetic
environment specified below. The customer or the user of 4000 Respiratory Monitor asma-
1 should assure that it is used in such an environment.
Emissions
test
Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1 The 4000 Respiratory Monitor asma-1 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 Battery Operated The 4000 Respiratory Monitor asma-1 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.
Harmonic
emissions
IEC 61000-3-2
Battery
Operated
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Battery
Operated

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Guidance and manufacturer’s declaration – electromagnetic immunity
The 4000 Respiratory Monitor asma-1 is intended for use in the electromagnetic
environment specified below. The customer or the user of the 4000 Respiratory Monitor
asma-1 should assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Compliance 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
±2 kV for power
supply lines
±1 kV for input/
output lines
Battery operated
Surge
IEC 61000-4-5 ±1kV differential mode ±2kV common
mode
Battery operated
device
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) for25 cycles
<5% 100V (>95% dip
in 100V) for 5 sec
Battery operated
Battery operated
Battery operated
Battery operated
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m Not applicable

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Guidance and manufacturer’s declaration – electromagnetic immunity
The 4000 Respiratory Monitor asma-1 is intended for use in the electromagnetic environment
specified below. The customer or the user of the 4000 Respiratory Monitor asma-1 should
assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
10 Vrms
150kHz to 80
MHz in ISM
bands
3 V/m
80 MHz to 2,5
GHz
Battery operated
3V/m from
80MHz to 2.5
GHz
Portable and mobile RF
communications equipment should
be used no closer to any part of the
4000 Respiratory Monitor asma-1
including cables, than the
recommended separation distance
calculated form the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
d=1.2√P 80MHz to 800MHz
d=2.3√P 800MHz 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:

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Recommended separation distances between portable and mobile RF communication
equipment and the 4000 Respiratory Monitor asma-1
The 4000 Respiratory Monitor asma-1 is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the 4000
Respiratory Monitor asma-1 can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters)
and the 4000 Respiratory Monitor asma-1 as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter (m)
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 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.

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14. FDA NOTICE
Caution: Federal Law restricts this device to sale by, or on the order of a physician.

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15. DECLARATION OF CONFORMITY
Product: 4000 Respiratory Monitor asma-1
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 2a 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