alpha III

Model 6000

User Instructions

l
Vitalograph
Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110 Fax: (01280) 823302
e-mail: [email protected]

Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany

Phone: (040) 54 73 91-0 Fax: (040) 547 391 40
e-mail: [email protected]

Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Phone: (913) 888-4221 Fax: (913) 888-4259
e-mail: [email protected]

Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6864100 Fax: (065) 6829289
e-mail: [email protected]

www.vitalograph.com

 Copyright Vitalograph 2002, 2003

Current Edition (Issue 3)

Cat. No. 07150

Vitalograph is a registered trademark

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 A B
C

J
D

F
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DESCRIPTION OF THE VITALOGRAPH ALPHA
The Vitalograph alpha is a portable office spirometer with an integral graphics
screen and thermal printer. It utilises the proven extremely accurate and stable
Fleisch type pneumotachograph measuring system.

Operation of the device is as far as possible intuitive, but it is recommended that

the following instructions are read thoroughly before using the instrument.

MAIN COMPONENTS OF THE VITALOGRAPH ALPHA

A Thermal Printer
B Flowhead
C Transport Strap
D Flowhead Tubing
E Power Inlet Socket
F On/off Switch
G Contrast Adjuster
H LCD Display
I Program Cartridge
J Keypad

FEATURES OF THE VITALOGRAPH ALPHA

The Vitalograph alpha features include; -
• Portable and easy to carry
• On-screen prompts and menu display
• Test data printed on a wide, fast printer
• Simple checking
• Predicted normal values and computer interpretation
• Provides a hard copy of results
• Automatically selects best tests
• Robust and proven reliability

GETTING THE VITALOGRAPH ALPHA READY FOR USE

First check that the contents of the packaging correlate with what is outlined on
the contents label on the inside of the packaging carton.

Environmental Conditions
The Vitalograph alpha spirometer must NEVER be used in atmospheres that are
potentially explosive, such as in the presence of ignitable or inflammable
anaesthetic gases or vapours.
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
4
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.

Program Cartridge
The Vitalograph alpha program is contained in a cartridge which must be
correctly inserted for normal operation. Removal of the cartridge is not
recommended when the unit is powered as this will result in loss of data or cause
operational problems, however the printer will not be damaged. If the Vitalograph
alpha does not work when it is switched on, switch it off and check the cartridge is
correctly fitted and pushed fully home. Then switch the Vitalograph alpha on
again. Also ensure that there is paper in the printer.

Power Supply
The Vitalograph alpha spirometer MUST be used with the purpose built low DC
voltage PowerSAFE unit (Cat No. 21001204) with which it is supplied, attempted
use with other devices may cause irreparable damage.

Connecting the PowerSAFE

The low voltage output cable from the PowerSAFE connects into a socket on the
right hand side of the Vitalograph alpha. Attach to the Vitalograph alpha before
plugging it into a mains supply. Plug in the mains plug to a suitable socket,
operate the ON/OFF switch on the right hand side of the instrument, and the
Vitalograph alpha is ready for use and will prompt the operator to verify/adjust
the date.

Flowhead and Tubing

The silicone rubber twin-tubing used to connect the flowhead to the instrument
may be loosely coiled around the storage lugs located at the rear of the
instrument, during transport. Care must be taken that the tubing does not become
damaged as this may result in erroneous test results. It is recommended that the
retaining strap be completely removed unless transporting the instrument.

Printout Records
Please be advised that all thermal paper fades with time. We strongly recommend
that all records be photocopied to ensure no loss of data and to maintain the
subject’s spirometry history file with summary test results.

Fitting a new roll of paper

The Vitalograph alpha is supplied with a roll of paper fitted into the printer. Note
that the outside of a roll will not give a strong print impression due to loss of
sensitivity on exposure to light. If the printer is used without paper, although not
recommended, the printer head will not be damaged.
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Replacement of the paper requires the instrument to be "ON", and can be carried
out even during a sequence of tests if necessary.

Press the ENT key when either of the screens of data displayed below is shown:

VITALOGRAPH- ALPHA

TODAY'S DATE: 11/01/02

IS THIS CORRECT? PRESS <Y> OR <N>

OR

VITALOGRAPH- ALPHA : MAIN MENU

1 : VC TEST 5 : NEW SUBJECT

2 : FVC TEST 6 : ACCURACY CHECK
3 : PRINT 7 : POST MODE
4 : CLEAR RESULTS

Unclip the paper roll support rod from the holder on the rear of the instrument and
discard the old paper roll centre. Use only Vitalograph Cat No 44058 paper –
damage caused by incorrect paper will invalidate the Warranty.

Fit the new roll of paper onto the paper rod as shown in the diagram below. Press
the ENT key, the printer will now operate, feed the paper into the slot below the
roller in the rear of the printer. Note that the coated side of the paper is inside the
roll.
The paper will then be pulled into the printer and appear out of the top. When this
occurs press the ENT key again to stop the printer. The paper rod may now be
replaced in the holder.

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Important: Printer paper must unroll as shown.
Paper should not be pulled through the printer manually. The paper feed On/Off
mechanism using the Vitalograph alpha keypad 'ENT' button should be used.

OPERATING INSTRUCTIONS

Keypad
The instrument is controlled by the 12 keys on the front panel. There are ten
numeric keys (0-9) two of which have dual functions. Key No. 9 doubles as Y
(Yes) and Key No. 0 doubles as N (No). The two remaining keys are ENT (Enter)
and DEL (Delete).
The numeric keys are used to enter data and the ENT key to indicate that data
entry is complete. The DEL key is used to delete a character that has been
entered in error.
The Vitalograph alpha is easy to use by following the instructions displayed on
the screen.

Date Entry
VITALOGRAPH - ALPHA

TODAY'S DATE: 11/01/02

IS THIS CORRECT? PRESS <Y> OR <N>

The above message will be displayed on the screen immediately the Vitalograph
alpha is switched on.
If the date is correct press the (Y) key. If incorrect then press (N). The date may
now be entered.

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N.B. The day, month and year must have two digits for a successful entry e.g.
01/01/01. Failure to enter the date fully will result in the incorrect digits being
erased, and the date will be requested again.

Subject Data Entry

Subject information is required to enable the instrument to calculate predicted test
result values. If these are not required press the ENT key when the subjects age
is requested. After each data entry is complete the ENT key must be pressed.

Reference Number
This may be any combination of numbers up to a maximum of 15 entries.

Subject Age
Enter subject’s age in years.

Subject height
The height may be entered in Inches or Centimetres – entries below 85 will
automatically be taken as inches.
N.B. On some versions only Centimetres may be entered.

Subject Sex
The spirometer assumes the subject to be MALE and shows the following display.
Use the Y and N keys accordingly to make the correct choice.

REFERENCE NUMBER : 1234

AGE : 46
HEIGHT : 170 CM
SEX : MALE ?

IS MALE CORRECT ? PRESS (Y) OR (N)

Subject Smoking Status

Some cartridges have an option to enter smoking status – smoker or non-smoker.
This will be used in the calculation of Lung Age.

After the subject demographics have been entered the printer immediately starts,
which confirms that the subject is now entered as ‘current’ in the Vitalograph
alpha.

Instruction of the Subject may now commence.

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Main Menu
Each item is selected by pressing the key with the corresponding number. The
ENT key enables a new roll of paper to be loaded into the printer mechanism.

VC Test (Static or Slow Vital Capacity)

This test may also be repeated as often required to get a valid result. The current
test volume (LAST) and highest volume achieved (BEST) being displayed
numerically on the screen.
A small vertical line on the graph also gives an indication of the highest volume
achieved in the series.

READY - <ENT> FOR MENU VC TEST

LAST BEST
5.20 5.42

FVC Test (Forced Exhalation Test)

This test may be repeated as many times as required to get a good result.
Minimum of three attempts is recommended. Commence each FVC test only
when the READY prompt is displayed.
Curves for each test will be superimposed on the screen. The "best" test will be
stored for output on the printed test report. (The "best" test has the highest FVC +
FEV1 sum).

READY - <ENT> FOR MENU FVC TEST

LAST BEST
FVC 4.97 5.35
FEV1 4.31 4.39
FEV1/FVC 86.7 82.1
PEF 696 696
FEF25-75 5.17 4.78

Print
The printer provides a report of subject data, test results and graphs.
To stop the printer, press the ENT key during printing.

Clear Results
Press "Y" to clear both VC and FVC test results. Subject data is retained so that
further testing may be performed.

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 VITALOGRAPH - ALPHA

ALL RESULTS WILL BE CLEARED

PRESS (Y) OR (N)

New Subject
The existing subject data and test results are cleared and the instrument prompts
for data from the next subject.

Post Mode (Pre/Post Drug Administration Testing)

The "best Pre" are saved and the "Post Test" mode is selected. A further series of
tests may then be performed after drug administration. The results of these tests
are compared with the results from the "Pre" test, the details are available on the
printed report as selected by menu option three above.
The display shows ‘POST’ to advise that this mode is switched on. To clear,
select ‘NEW SUBJECT’.

Performing The Tests

HYGIENE: It is vital for the user to set guidelines for protective hygiene measures
whilst performing spirometry testing. There are three main potential sources of
cross contamination, skin contact; aerosolised particles and saliva/body fluids. By
far the most significant is the last item – a minimum requirement is to use a new
disposable mouthpiece for each subject tested. We recommend using the
SafeTway mouthpiece for expiratory tests or the Bacterial/Viral Filter for testing
involving inspiratory and expiratory manoeuvres. We also recommend that a delay
of at least 5 minutes be allowed between subjects. This allows aerosolised
organisms to be removed by gravitational sedimentation between tests. (Am J
Respir Crit Care Med Vol 159. pp 610-612, 1999).

SUBJECT INSTRUCTION: It is essential that the subject performing the test is

clearly instructed in the procedure before the start of each test. The Operator
must demonstrate each manoeuvre, using a mouthpiece, prior to instructing the
subject.

A very enthusiastic performance by the operator is required so that a maximum

effort is made when carrying out the forced expiratory test. A subject who has not
previously had a spirometry test should make two or more practice attempts until it
appears that a maximum effort is being obtained.
IMPORTANT NOTE: It is vital that the operator ensures the subject keeps their
fingers clear of the outer end of flowhead during testing.

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Testing may be done either in the sitting or standing position. Indication of position
is necessary on the report. The Standing position may not be appropriate in some
circumstances, such as in hospitals where many patients may not be able to
tolerate the standing position, especially when making forced manoeuvres. The
selection of the position for testing is, therefore, an individual one. If the standing
position is used, an appropriately shaped chair should be placed behind the
patient/subject so he/she can quickly and easily be eased into a sitting position if
he/she becomes light-headed during the manoeuvre.

Read the following instructions to the subject so that testing is performed properly.
VC test: -
• Stand up.
• Take hold of the unit, keeping it a vertical position and away from your mouth
(ensure that the device is not jerked while handing it to the subject).
• Inhale as deeply as possible and insert the mouthpiece into your mouth,
clamping it between your teeth.
• Close your lips round the mouthpiece.
• Exhale normally for as long as possible.
FVC test: -
• Stand up.
• Take hold of the unit, keeping it in a vertical position and away from your
mouth (ensure that the device is not jerked while handing it to the subject).
• Inhale as deeply as possible and insert the mouthpiece into your mouth,
clamping it between your teeth.
• Close your lips round the mouthpiece.
• Exhale as quickly as possible and try to keep exhaling for at least 6 seconds.

The patient's best test can be recorded on a Serial Spirometry Record sheet along
with a plot of the FEV1 value. Pads of 50 can be ordered from Vitalograph (Cat.
No. 63054).

Where the ALPHA III recognises errors in the test technique, error messages may
be displayed, e.g. SLOW START will be displayed if the back extrapolated time
zero point exceeds 10% of FVC (This could be due to the subject not biting the
mouthpiece giving rise to tongue obstruction, or simply not blasting out hard
enough at the start of test).

CHECKING ACCURACY OF THE VITALOGRAPH ALPHA

The Vitalograph alpha has an extremely stable measuring system. Although
spirometry standards recommend that the device accuracy be checked on a daily
basis, the need to adjust the calibration is very infrequent and normally is
indicative of a fault or procedural error. Although it is not a specified requirement,
a routine annual service on this equipment is strongly recommended. The
equipment used to perform the accuracy check should itself be certified and
traceable to national or international standards.
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Accuracy Checking Procedure
The Accuracy Checking routine allows the user to simply check if the accuracy of
the instrument is within the required tolerance. To perform the accuracy check a
precision syringe is required, such as the 1-L Precision Syringe available from
Vitalograph (Cat. No. 20408). Before attempting to check the accuracy it is
essential that the flowhead and syringe are at the same temperature. Breathing
through the flowhead raises its temperature. If the flowhead has recently been
used for testing prior to accuracy checking, then the temperature must be lowered
to ambient by repeatedly pumping room air through it using the syringe.

The operator is requested to enter the ambient temperature, meaning the

temperature of the syringe. THIS MUST BE MEASURED ACCURATELY. A
precise volume of air must be pumped through the flowhead when requested on
the screen. Do not pump too fast or too slowly, a smooth continuous pump will
deliver the correct volume. Pumps lasting less than a second will be ignored by
the device. Follow the instructions on the screen. When entering the volume of the
syringe, please note that this is the stroke volume of the syringe and is unrelated
to the number of pumps of the syringe. If the error is less than, 3%, then the
device is accurate within tolerance and the calibration setting does not need to be
adjusted.

Calibration Updating Procedure

This is only necessary if the error is greater than 3% when performing an accuracy
check. Before considering adjusting the calibration, re-check the accuracy and
attempt to locate the fault/cause of error. Adjusting the calibration is carried out
totally by control from the keyboard and no mechanical adjustment is necessary.
The revised calibration is retained until altered again, even when the spirometer is
switched off.

When the accuracy has been checked or the calibration changed there is a choice
of either ending the routine or of double checking the result by re-entering the
accuracy checking procedure as described above. If the calibration has been
adjusted, it is strongly recommended that the accuracy be checked again. Out of
limits results is indicative of a fault in the device or the checking procedure.

When the accuracy checking has been completed a printed record of the
calibration may be obtained. A calibration REPORT will be printed if the calibration
has been updated, a calibration CHECK will be printed if the calibration remains
unaltered.

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CLEANING INSTRUCTIONS
All parts of the Vitalograph Alpha require regular cleaning, i.e. the removal of
visible particulate contamination. The parts of the Vitalograph Alpha that make up
the flowhead also require disinfecting. Vitalograph recommends that cleaning and
disinfecting should normally be carried out on a weekly basis. In addition to a
weekly cleaning and disinfection cycle, Vitalograph recommends cleaning and
disinfection of equipment to be carried out after use on infected subjects or prior to
use on immuno-compromised subjects. The user must determine what level of
disinfection is appropriate and acceptable in any particular circumstance.

Routine Practice
It is recommended that the Flowhead Assembly be regularly cleaned and
disinfected. In the event of visible contamination to the FLOWHEAD CONES or
FLOWHEAD ELEMENT - these should be cleaned and disinfected.

The FLOW CONDITIONING MESHES should be replaced regularly. The

frequency of this is dependent on the Facilities’ Risk Assessment, usage, and test
environment, but should be at least monthly or every 100 subjects (500 blows).
They should also be replaced in the event of damage, or if visibly contaminated.

It is recommended to replace the complete Flowhead Assembly: FLOWHEAD

COMPLETE and FLOWHEAD CONNECTION TUBE, at least annually.

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Cleaning/Disinfecting- Recommendations Chart
Part Material Clean/ Autoclave Recommended
Disinfect Disinfectants
Case Polystyrene Clean No Wiping with a 70%
Exterior high density Isopropyl Alcohol
foam with impregnated cloth
epoxy paint provides a suitable form
Display Glass Clean No of cleaning and low-
Screen ABS Clean No level disinfection.
Surround
Keypads ABS Clean No
Flowhead Silicone Clean Viable
Tubing Rubber
Flowhead Aluminium Clean Viable
Body
Fleisch Aluminium, Clean & Viable Disinfect by immersion
Element Stainless Disinfect in sodium
Assembly Steel, Acetal dichloroisocyanurate
Flowhead TPX Clean & Viable solution at 1000 ppm
Cone Disinfect concentration of free
Flowhead Anodised Clean & Viable chlorine for 15 minutes.
Mesh Aluminium Disinfect (see recommended
Housing cleaning/disinfection
Flowhead Acetal and Disinfect No method for the
Conditioning Polyester /Dispose Vitalograph Alpha
Mesh Flowhead)
Flowhead TPX Clean & Viable The flowhead will also
End Cap Disinfect withstand autoclaving at
134°C for 3 minutes.

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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Disassembling the Flowhead for Cleaning and Disinfecting

1. Remove the cone and the end cap from the flowhead.
2. Remove the flow conditioning meshes from inside the cone and the end
cap, and either clean or discard them.
3. Hold the unit case with one hand and the exposed part of the Fleisch
element with the other. Pull and twist the Fleisch element to remove it
entirely from the case.
End Cap
Flow Conditioning
Mesh
Fleisch Element

Flowhead body
Flow Conditioning
Mesh
Cone

• Clean each separate part of the flowhead by washing in a mild detergent to

remove particulate contamination. To clean the Fleisch element, swill
vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” at
capillaries. If the flow conditioning meshes appear dirty or blocked they should
be thrown away and replaced. The flowhead body does not require
disinfection, but may disinfected with the rest of the flowhead for convenience.
• Rinse with clean water.
• 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 hot water to aid drying.
• Leave to dry completely before reassembling. Drying the Fleisch element
assembly may require placing it in a warm place overnight. A drying cabinet is
ideal; alternatively another heat source could be used.
• 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, flowhead tubing, flowhead body and keypads. Repeat at
least weekly to prevent 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.
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Reassembling the Fleisch Flowhead

1. Ensure that no liquid remains in the holes, grooves or pressure tappings of

the Fleisch element assembly.
2. If replacing the sealing rings, check for damage and very lightly grease
each ring before replacing them in the housing grooves. (Molycote 55
silicone grease or its equivalent is recommended.)
Make sure you remove excess grease as it can cause blockage of the holes
in the flowhead body, resulting in false readings.
3. Place cleaned or new flow conditioning meshes into the cone and the end
cap.
4. When re-assembling ensure that the BLUE PRESSURE TAPPING is
closest to the wider end of the element assembly. Also ensure that the
flowhead body is pushed fully home.
5. When attaching the FLOWHEAD CONNECTION tubing ensure that the
matching coloured pressure tappings on the FLOWHEAD and the
Vitalograph alpha are connected to each other. When connecting the
double tubing from the flowhead to the ports on the side of the unit it is very
important that the tubing is pushed fully home over the ports. This is critical
to obtain accurate results from the unit.
6. When the flowhead is reassembled, an accuracy check must be performed.

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CONSUMABLES AND SPARE PARTS
Cat. No. Description
20242 Safetway Mouthpieces (200)
20303 Noseclips (10)
20408 1-L Calibration Syringe
28350 Bacteria/Viral Filters (50)
42084 Flow Conditioning Meshes (10)
44058 Thermal Printer Paper (5)
31297SPR Mains Power Cable - UK
31375SPR Mains Power Cable - USA
31376SPR Mains Power Cable - Euro
62019SPR Flowhead Cone
62006SPR Flowhead End Cap
21001204 PowerSAFE

EXPLANATION OF SYMBOLS

k Type BF equipment

j Class II

VA Power rating

V Voltage DC

h Attention (reference relevant section in manual)

Power input connector

On (I) / Off (O) switch

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CE Notice
Marking by the symbol l indicates compliance of the Vitalograph alpha to the
Medical Devices directive of the European Community. Such marking is indicative
that the Vitalograph 2120 meets or exceeds the following technical standards:
• EN60601-1 - “General requirements for safety”
• EN55011 - “Radiated and mains conducted emissions for industrial, scientific
and medical (ISM) radio-frequency equipment”
• IEC801-2 - “Electromagnetic compatibility for industrial-process measurement
and control equipment Part 2: Electrostatic discharge requirements.”
• IEC801-3 - “Electromagnetic compatibility for industrial-process measurement
and control equipment Part 3: Radiated electromagnetic field requirements.”

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

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DECLARATION OF CONFORMITY
(To the requirements of 93/42 EEC 169, volume 36)

Product: Vitalograph Alpha


Vitalograph hereby ensures and declares that the above product
associated with this user manual, bearing the CE Mark, which is
classified as 2a, meet the following provisions of Annex II of the
Medical Devices Directive as per Article 11, section 3a, excluding
point 4 of Annex II.

Vitalograph design and manufacture in accordance with the following standards:

• European Medical Devices Directive 93/42/EEC L169 Vol. 36
• BS EN ISO 9001:1994 : Quality Systems - Model for Quality Assurance in
Design, Development, Production, Installation and Servicing.
• EN 46001:1996 : Specification for application of EN ISO 9001 to the
manufacture of medical devices.
Certifying Body: British Standards Institute - Certificate Nos. Q5460 & CE 00772

FDA Quality System Regulation: 21 CFR Sections 820 & 803.

Signed on behalf of Vitalograph (Ireland) Ltd. / Vitalograph Ltd.

B. R. Garbe.
Group Managing Director.

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TECHNICAL SPECIFICATIONS

Operating Voltage Range: 100 to 250 VAC

Operating Frequency: 50 or 60 Hz
Power Supply Output: Nominal 10 Volts D.C. at 1.2 Amp
Flow Detection Principle: Fleisch Pneumotachograph.
Back pressure <0.1 kPa/L/s @ 14 L/s
Maximum Flow rate: 16 L/s
Maximum Recording Time: VC 30 s
FVC 20 s
Data Sampling Rate: 100 Hz
Operating Temperature Range: 10°C to 40°C
Measuring Accuracy: Volumes ± 3%
Flowrates ± 3%
System Resolution: Volume 0.01 L
Peak Flowrate 1 L/m
All other Flowrates 0.01 L/s.
Dimensions: 300X250X130 (Width, Depth, Height).
Standards and Approvals: EN 60601-1:1990
EN46001
Storage Conditions Store between 0-50°C and 10-95% Relative
Humidity

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 contact any of the offices at the start of this
manual or your local Vitalograph distributor.

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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.

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