Vitalograph Model 4000 Installation guide

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lung monitor BT
Model 4000
User Training Manual
Medical Devices Directive
93/42/EEC L169, Vol. 36.
EN ISO 13485
FDA QSR 21 CFR 820/803
Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland

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UK Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.co.uk
Export Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: [phone]
Fax: [phone]
e-mail: [email protected]
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: [phone]
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 4)
Cat. No. 07560
is a registered trademark

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Table of Contents
1. WARNINGS AND ADVISORY NOTICES
2. MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR BT
3. WHAT IS THE VITALOGRAPH LUNG MONITOR BT USED FOR?
4. HOW TO USE THE VITALOGRAPH LUNG MONITOR BT
1. SETTING PERSONAL BEST (REFERENCE) VALUES
2. SETTING MANAGEMENT ZONES
3. PERFORMING THE TEST
4. REVIEWING PREVIOUS RESULTS
5. DELETING ALL RESULTS HISTORY
6. SENDING TEST RESULTS TO VITALOGRAPH REPORTS
5. CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR BT
1. HOME USE CLEANING AND DISINFECTION OF THE VITALOGRAPH LUNG
MONITOR BT
2. CLEANING AND DISINFECTING THE VITALOGRAPH LUNG MONITOR IN CLINIC
USE
1. Table of Materials Used & Cleaning/Disinfection Methods
2. Removing the Flowhead for Cleaning and Disinfecting
6. CONSUMABLES, ACCESSORIES AND SPARE PARTS
7. EXPLANATION OF SYMBOLS
8. TECHNICAL SPECIFICATIONS
9. CE NOTICE
10. FDA NOTICE
11. DECLARATION OF CONFORMITY
12. GUARANTEE

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1. WARNINGS AND ADVISORY NOTICES
Note: Please read all the information in this manual before using the Vitalograph lung monitor BT
device. A full set of instructions, including cleaning instructions, is available at
www.vitalograph.co.uk.
The Vitalograph lung monitor is recommended for single patient use.
The Vitalograph lung monitor should be only used under the supervision of a healthcare
professional.
Symptoms must take precedence over device measurements*.
Before use, ensure that the batteries do not exceed their shelf life, as indicated on the
batteries.
Store in a clean dry place.
* If the patient at home thinks that the device is not reading correctly, they must advise the
healthcare professional immediately.
2. MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR BT
A Flowhead
B On/Off Button
C LCD
D Keypad - Up, Down & Enter Button
3. WHAT IS THE VITALOGRAPH LUNG MONITOR BT USED FOR?
The Vitalograph lung monitor BT is an easy to use home monitoring device designed to record key
lung function parameters for those with respiratory conditions, including cystic fibrosis and
transplant patients. The lung monitor can also be used in primary and secondary care,
occupational health and clinical studies.

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The primary features of the Vitalograph lung monitor are:
Measures FEV1, FEV6 and the ratio
Displays % of personal best FEV1
Simple to use
Electronic record, eliminating need for record cards
Stores 200 test sessions
Quality of blow indicator
FEV1 zones can be personalized
Uses disposable AAA batteries
4. HOW TO USE THE VITALOGRAPH LUNG MONITOR BT
4.1. Setting Personal Best (Reference) Values
Personal Best (reference) values can be set for forced expiratory volume after 1 second (FEV1).
To set the Personal Best (reference) FEV1, 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 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.
4. Press ENTER to keep this reference FEV1 value. The device will return to the test
screen.
Note: to de-activate zones, set the FEV1 reference value to 0.00.
4.2. Setting Management Zones
The Vitalograph lung monitor can be set for use with 3 or 4 zone management plans. The zone
percentages are factory set to 2 boundaries, 95% & 90%, i.e. 3 Zones (95-100%, 90-95%, 0-90%).
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 10 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.
4. Press ENTER to set the top (Green/Yellow) boundary value.

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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.
4.3. Performing the Test
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 lung monitor 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, as FAST and as LONG as possible (the device will stop taking readings
after 6 seconds). Be careful not to block the mouthpiece with the tongue or teeth. A ‘spitting’
action will give false readings.
6. Following each blow and at the end of the test session, the FEV1 value will be displayed and
below that, FEV1 % Personal Best results for that blow.
7. Pressing the button will show the FEV6 result.
8. Pressing the button again will show the FEV1/FEV6 result.
9. Pressing the button again will show the FEF25-75 result.
10. With the blow icon showing, blow again ( ). Usually 3 blows are required.
11. To view the best test in the session (best FEV1 and best FEV6), 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 Vext (extrapolated volume) is > 5% or 150mL of FEV6 or
a cough is detected in the 1st second.

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If the subject experiences dizziness or fatigue during the test session, wait until this passes before
blowing again or terminate the session.
4.4. Reviewing Previous Results
The Vitalograph lung monitor can store up to 200 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 FEV1 result will be displayed
for approximately 3 seconds, followed by the best FEV6 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.
4.5. 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.
3. A long beep will indicate success and the device will return to the test screen.
4.6. Sending Test Results to Vitalograph Reports
The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be
stored as a PDF file and viewed or printed.
Before you can transmit you must first have the Vitalograph Reports Utility installed and running on
your PC. If the ‘Snake V’ icon is showing in your PC System Tray then the utility is running, if not
refer to Vitalograph Reports Utility instructions.
1. Ensure the Vitalograph lung monitor BT device is powered on.
2. On Vitalograph Reports ensure ‘Vitalograph lung monitor’ is selected as the device. Ensure
that ‘Connect using Bluetooth’ tick box is ticked.
3. Click on the ‘Discover Bluetooth Devices’ button. The Vitalograph lung monitor BT device will
be found and saved for future use.
4. There are two ways to print the test results from the lung monitor:
a. When the device is ready for a test ( ), press the button for 3 seconds on the
device will show the Report icon ( ).

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b. After completing the test session, press the or button until the print ( ) screen is
displayed. Press .
5. On the Vitalograph Reports enter the Subject Demographic details and Comments. Select
‘Continue’ on Vitalograph Reports when you are finished entering the information.
6. Select a location for the test report on your PC as requested by Vitalograph Reports. A PDF
of the test results will appear and will also be stored to the PC.
5. CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR BT
5.1. Home use cleaning and disinfection of the Vitalograph lung monitor
The Vitalograph lung monitor 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.
Part Material Cleaning Recommendation Disinfection
Recommendation
Plastic
Mouthpieces ABS Wash in warm soapy water. Rinse in clean water Cold liquid, e.g. Effervescent Chlorine
solution
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%)
5.2. Cleaning and Disinfecting the Vitalograph lung monitor 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.

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5.2.1. 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.
Part Material Clean/
Disinfect
Autoclave
Possible?
Recommended
Disinfectants
Plastic
Mouthpiece ABS Do not use in
clinic
No Disinfect by immersion in
sodium dichloroisocyanurate
solution at 1000ppm
concentration of free chlorine
for 15 minutes
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 lung monitor 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.

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5.2.2. Removing the Flowhead for Cleaning and Disinfecting
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.
6. CONSUMABLES, ACCESSORIES AND SPARE PARTS

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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)
7. EXPLANATION OF SYMBOLS
Type BF equipment
Class II
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)
Transmit Report Symbol
Memory 90% - 100% Full Icon
Flashes when memory reaches 100%
8. TECHNICAL SPECIFICATIONS

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Material: PC/ABS
Accuracy: Better than ± 3%
Flow Impedance: Better than 0.15kPa/L/s at 14L/s
Measurement Range: 0 – 9.99 L BTPS
Performance And Safety
Standards: ISO EN 23747:2007 ATS/ERS Guidelines 2005
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
! Bad Test Criteria: Slow start of test (Vext>5%) or a cough detected in the first
second
Auto power down time Set to 2 minutes as standard
Communications Bluetooth
9. CE NOTICE
Marking by the symbol indicates compliance of the Vitalograph 4000 Respiratory Monitor lung
monitor device to the Medical Devices Directive of the European Community. Such marking is
indicative that the Vitalograph 4000 Respiratory Monitor lung monitor device meets or exceeds the
following technical standards:

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Guidance and manufacturer’s declaration – electromagnetic emissions
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of 4000 Respiratory Monitor lung monitor
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 lung monitor 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 The 4000 Respiratory Monitor lung monitor 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
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Class A

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Guidance and manufacturer’s declaration – electromagnetic immunity
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the 4000 Respiratory Monitor lung
monitor 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
device
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
device
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m Performance A Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.

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Guidance and manufacturer’s declaration – electromagnetic immunity
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the 4000 Respiratory Monitor lung
monitor 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
device
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 lung
monitor including cables, than the
recommended separation distance
calculated form the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
80MHz to 800MHz
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 lung monitor
The 4000 Respiratory Monitor lung monitor 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 lung monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the 4000 Respiratory Monitor lung monitor 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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10. FDA NOTICE
Caution: Federal Law restricts this device to sale by, or on the order of a physician.

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11. DECLARATION OF CONFORMITY
Product: Vitalograph 4000 Respiratory Monitor lung monitor
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.
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
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director

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12. GUARANTEE
Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter
called the Company) guarantee to repair or at its opinion 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 whom it was purchased for advice. The
Company does not authorise 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.
This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not
affect these rights in any way.