Vitalograph asma-1 4000 User manual

Vitalograph asma-1TM
User Manual
Model No. 4000
Medical Devices Directive
93/42/EEC L169, Vol. 36.
EN ISO 13485
FDA QSR 21 CFR 820/803
Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland
1

Table Of Contents
Warnings and Advisory Notices ...................................................................................................3
Main Components of the Vitalograph asma-1TM........................................................................... 4
What Is The Vitalograph asma-1TM Used For?.............................................................................4
What Is The Vitalograph asma-1TM Used For?.............................................................................5
The Asthma Sufferer....................................................................................................................5
How To Use The Vitalograph asma-1TM.......................................................................................6
Setting Personal Best (Reference) Values ...............................................................................6
Setting Management Zones .....................................................................................................6
Performing The Test................................................................................................................. 7
Reviewing Previous Results .....................................................................................................8
Deleting All Results History ......................................................................................................8
Care and Cleaning Of The Vitalograph asma-1TM In Home Use ..................................................9
Cleaning and Disinfecting the Vitalograph asma-1TM In Clinic Use .......................................... 9
Table of Materials Used & Cleaning/Disinfection Methods ..................................................... 10
Consumables, Accessories and Spare Parts ............................................................................. 11
Explanation of Symbols..............................................................................................................11
Technical Specifications.............................................................................................................12
Warranty .................................................................................................................................... 12
Appendices ................................................................................................................................ 13
Quick Start Guide ................................................................................................................... 13
Regulatory Notices for the Vitalograph asma-1TM...................................................................14
CE Notice............................................................................................................................14
FDA Notice .........................................................................................................................14
Declaration of Conformity ................................................................................................... 16
Copyright Vitalograph 2007
Print Ref. No. 07380 Current Edition (Issue 2)
2

Warnings and Advisory Notices
Note: Please read all the information in this manual before using the Vitalograph copd-6. A full
set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk.
• This Vitalograph device is intended to measure lung function for use in clinic with disposable
mouthpieces or filters or for patient use at home under medical supervision.
• Take care not to block the mouthpiece with the tongue or teeth. A ‘spitting’ action or
coughing will give false readings.
• If used at home symptoms must take precedence over device measurements*.
• If the device is used for longer than its specified life, the accuracy of the device may
deteriorate.
• Before use, ensure that the batteries do not exceed their shelf life, as indicated on the
batteries.
• Store in a clean dry place.
* If you suspect that a defect has occurred you should check the Vitalograph
copd-6 for operation and accuracy.
3

Main Components of the Vitalograph asma-1TM
A Flowhead
B On / off button
C Display
D User buttons
C
A
D
B
4

What Is The Vitalograph asma-1TM Used For?
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.
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.
5

How To Use The Vitalograph asma-1TM
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, D.
2. When the device is ready for a test ( ), press the Band Cbuttons together for 3 seconds.
3. The reference PEF value can now be set. This is done by pressing the Bbutton and
releasing when the value is reached. Press the Cto roll back.
The values will increase/decrease in values of 10. If the button is kept depressed, the values
will scroll faster.
4. Press Eto keep this reference PEF value.
Press E again to exit, or to set the Best Test (reference) FEV1:
1. The reference FEV1 value is set by pressing the Bbutton and releasing when the value is
reached. Press the Cto 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 Eto 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.
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;
Green Green
YellowYellow
Oran
g
e
Red Red
3 Zone 4 Zone
Top boundary
Top boundary
Middle boundary
Bottom boundary
Bottom boundary
To set the boundary percentage values for 3 zones, follow these steps;
1. Turn the device on, D.
2. When the device is ready for a test ( ), press and hold the Eand Bbuttons for
approximately 3 seconds.
3. The top (Green/Yellow) boundary can now be set. This is done by pressing the Bor C
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.
6

4. Press Eto set the top (Green/Yellow) boundary value.
5. The bottom (Yellow/Red) boundary can now be set. This is done by pressing the Bor C
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.
6. Press Eto set the bottom (Yellow/Red) boundary value.
7. Only 2 boundaries are required for the 3 zone system, so the next value should be selected
as 0% (default). Press E. 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 Bbutton
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 can
not be set at a value that is greater than the top boundary value or less than the bottom
boundary value.
3. Press Eto set the middle (Yellow/Orange) boundary value. The device will return to the test
screen.
Performing The Test
1. Sit down when blowing into the device (unless the physician advises otherwise).
2. Turn the device on, D, 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 Ebutton. 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. If the subject experiences dizziness or fatigue during the test
session, wait until this passes before blowing again or terminate the session.
For a good test, the time to peak flow must be 120ms or less, and no cough in the 1st second.
7

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, D.
2. When the device is ready for a test ( ), press the Ebutton 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 Bbutton will show ‘2’, the previous
test, and so on.
5. Press E. The device will return to the test screen.
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, D.
2. When the device is ready for a test ( ), press and hold the Eand Cbuttons for
approximately 10 seconds.
3. A long beep will indicate success and the device will return to the test screen.
8

Care and Cleaning Of The Vitalograph asma-1TM In Home Use
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.
The device should be kept clean and dust free. If the asthmatic suspects that the device is
damaged or measuring incorrectly they should take it to their doctor who will be able to check its
operation and accuracy.
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, paying special attention to the mouthpiece area.
Cleaning and Disinfecting the Vitalograph asma-1TM 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.
9

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.
Part Material Cleaning
Recommendation
Disinfection
Recommendation
Plastic
Mouthpiece
ABS Wash in warm soapy
water. Rinse in clean
water
Cold liquid, e.g.
Effervescent Chlorine
solution
Body PC / ABS Wipe with a damp
cloth
Alcohol wipe
(IPA 70-90%)
Fascia Polycarbonate Wipe with a damp
cloth
Alcohol wipe
(IPA 70-90%)
Buttons Synthetic Rubber Wipe with a damp
cloth
Alcohol wipe
(IPA 70-90%)
SafeTway
mouthpiece or
BVF
Cardboard / ABS Dispose – single use Dispose – single use
All external parts of the Vitalograph asma-1 require cleaning, i.e. the removal of visible
particulate contamination. Do not attempt to insert any object or to clean the rotor or stator in
the measuring system.
This device is not designated as a ‘sterile’ device. Wiping with a 70% Isopropyl Alcohol
impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case
exterior. 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.
10

Consumables, Accessories and Spare Parts
Cat. No Description
40161 Plastic Mouthpiece for asma-1 (Pack of 12)
20303 Disposable Noseclips (200)
20242 SafeTway®disposable mouthpieces (200)
20980 Mini SafeTway®mouthpieces (50)
28350 BVF®Bacterial/Viral Filters (50)
Explanation of Symbols
Device symbols;
k
Type BF equipment
j
Class II
The device must be taken to separate collection at the product end-of-life. Do not
dispose of these products as unsorted municipal waste.
h Attention (reference relevant section in manual)
User Interface Symbols;
Memory Symbol
Battery status: Full
Battery status: Half
Battery status: Empty (flashing)
Blow Now Symbol
! Bad Test Symbol (Cough or tPEF>120ms)
11

Technical Specifications
Material: PC/ABS
Accuracy: Better than ± 3% (FEV1), ± 5% (PEF)
Flow Impedance: Better than 0.15kPa/L/s at 14L/s
Measurement Range: PEF: 0 – 840 L/min BTPS
FEV1: 0 – 9.99 L BTPS
Performance And Safety Standards: EN ISO 23747:2007
Electromagnetic emissions: CISPR 11 Group 1 (battery operated)
Electromagnetic immunity: IEC 61000-4-2, IEC 61000-4-3 (battery
operated)
Sensor Stator/rotor
Power Supply 2 x AAA batteries
Operating Temperature 17 – 37°C
Auto power down time Set to 2 minutes as standard
Warranty
Your Vitalograph asma-1 is guaranteed for one year*. Replace if it is faulty, otherwise replace
the unit every three years.
* Excepting accidental / transit damage or inappropriate use of the device.
Vitalograph Ltd. Maids Moreton Buckingham MK18 1SW England Tel: [phone]
Fax: [phone] Email: [email protected] www.vitalograph.co.uk
Vitalograph Inc. 13310 West 99th Street Lenexa Kansas 66215 USA Tel.: [phone] Fax:
[phone] Email: [email protected] www.vitalograph.com
Vitalograph GmbH. Jacobsenweg 12 22525 Hamburg Germany Tel: [phone] Fax: (040)
547391-40 Email: [email protected] www.vitalograph.de
Vitalograph (Ireland) Ltd. Gort Road Business Park Ennis Co.Clare Ireland Tel.: [phone]
Fax: [phone] Email: [email protected] www.vitalograph.ie
Copyright and trademarks: Vitalograph, BVF™, SafeTwayand copd-6™ are trademarks of
Vitalograph Ltd.
12

Appendices
Quick Start Guide
13

Regulatory Notices for the Vitalograph asma-1TM
CE Notice
Marking by the symbol lindicates 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 referenced technical standards.
The Vitalograph 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.
The Vitalograph asma-1 is battery operated and 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.
The Vitalograph asma-1 is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
• Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material,
the relative humidity should be at least 30%.
• Power frequency magnetic fields should be at levels characteristic of a typical location in a
typical commercial or hospital environment
• Interference may occur in the vicinity of equipment marked with the following symbol - .
FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a physician.
14

Recommended separation distances between portable and mobile RF communication
equipment and the system
The Vitalograph asma-1 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the system can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the system 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
11.2m 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.
15

16
Declaration of Conformity
Product: Vitalograph asma-1TM
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.
This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the
following provisions of Annex II of the Medical Devices Directive as per Article
11, section 3a, excluding point 4 of Annex II.
This device complies with the EMC Directive 89/336/EC, conformance
demonstrated by following standard EN60601-1-2:2001. Equipment
classification: Residential.
l
Canadian Medical Device Regulation {CMDR}
FDA Quality System Regulation {QSR} 21 CFR 820.
EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for
regulatory purposes.
Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI}
Certificate Nos. CE 00772, MD 82182, FM 83550