Vitalograph logo
COMPACT

Model 6600

User Training Manual

Device illustration

 

CE


 

Vitalograph Ltd. UK
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: (01280) 827110
Fax: (01280) 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk

Vitalograph Ltd. International
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: +44 1280 827120
Fax: +44 1280 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph GmbH
Rellinger Straße 64a,
D-20257 Hamburg,
Germany
Tel: +49 40 547391-0
Fax: +49 40 547391-40
E-mail: info@vitalograph.de
www.vitalograph.de

Vitalograph Inc.
13310 West 99th Street,
Lenexa, Kansas, 66215,
USA
Toll Free: 800 255 6626
Tel: (913) 730 3200
Fax: (913) 730 3232
E-mail: vitcs@vitalograph.com
www.vitalograph.com

Manufacturer symbolVitalograph (Ireland) Ltd.
Gort Road Business Park,
Ennis, Co. Clare,
Ireland
Tel: +353 65 6864100
Fax: : +353 65 6829289
E-mail: sales@vitalograph.ie
www.vitalograph.ie

Vitalograph Ltd. Hong Kong /China
Unit 2001, Floor 20, Block A,
New Trade Plaza, 6 On Ping Street,
Shatin
Hong Kong
Phone: +852 2117 2678
Fax: : +852 2117 2679
E-mail: sales@vitalograph.cn
www.vitalograph.cn

© Copyright Vitalograph 2016
Current Edition (Issue 8)
Cat. No. 07345

Vitalograph logo is a registered trademark


 

Table of Contents

  1. DESCRIPTION OF THE VITALOGRAPH COMPACT
    1. Indications for Use
  2. CONTRAINDICATIONS AND PRECAUTIONS FOR USE
  3. MAIN COMPONENTS OF THE VITALOGRAPH COMPACT
  4. FEATURES OF THE VITALOGRAPH COMPACT
  5. GETTING THE VITALOGRAPH COMPACT READY FOR USE
  6. CLEANING INSTRUCTIONS
    1. Cleaning and Low Level Disinfection of the Vitalograph COMPACT
    2. Disassembling and Cleaning of the Fleisch Flowhead
    3. Reassembling and Low Level Disinfection of the Fleisch Flowhead
  7. FAULT FINDING GUIDE
  8. CUSTOMER SERVICE
  9. CONSUMABLES AND ACCESSORIES
  10. EXPLANATION OF SYMBOLS
  11. TECHNICAL SPECIFICATIONS
  12. CE NOTICE
  13. FDA NOTICE
  14. DECLARATION OF CONFORMITY
  15. GUARANTEE

1. Description of the Vitalograph COMPACT

The Vitalograph COMPACT Expert is a networkable medical workstation designed for use by trained medical professionals for physiological measurements on human subjects.  Test data is automatically stored to the relevant subject record. Test data can be viewed on screen and reports can be generated for transmission or printing. There are a variety of backup and other configuration options.

The software running on the COMPACT Expert is intended to allow it to be used as a standalone lung function testing device or in conjunction with other accessory devices for example Pulse Oximeter, Blood Pressure, Medical Weighing Scales, FeNO and Electrocardiogram.

Compatible third party devices are:

COMPACT  is intended for use in phase one clinical trials units, occupational health centres, hospitals, pharmaceutical research centres, physicians’ offices, and wherever else advanced spirometry, electrocardiogram or any of the accessory device measures is required. COMPACT is not intended for use for vital signs monitoring in a critical-care setting.

This User Training Manual relates to the hardware of the COMPACT only. For guidance on the Spirotrac software application running on COMPACT please refer to the Spirotrac User Training Manual (07402), available through the help menu on the device and on the Vitalograph website.

Information about the software can be obtained from the About box. This information can be used if any queries are made to Vitalograph or a service agent.

To access the About box:

  1. Select About from the Help menu

The main components for the Vitalograph Compact are shown in Figure 1.

Warning: No modification of this equipment is allowed. Any unauthorised changes to the COMPACT device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.


    1.1. Indications for Use

The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measure patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

 

2. Contraindications and Precautions for use

  1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph Compact device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.
  2. The Vitalograph Compact is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.
  3. For spirometry testing a new Bacterial Vital Filter (BVF) should be used for each subject to protect both device and subject. A BVF is for single subject use only. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.
  4. Spirometry may support or exclude diagnosis, but it cannot make one (ATS/ERS 2005).
  5. When getting the Vitalograph Compact ready for use ensure that the ribbed side of the tubing is connected to the ribbed half of the connector as per the instructions in section 5. If tubing is connected the wrong way, spirometry results may appear to be inverted.
  6. When using the Vitalograph Compact ensure that the flowhead connecting tube is not pinched or trapped as spirometry results may appear to be inverted.
  7. Take care not to block the mouthpiece with the tongue or teeth during testing. A 'spitting' action or cough will give false readings.
  8. Subject fatigue may occur during spirometry testing depending on the subjects characteristics e.g age, health status. To avoid this the subject may sit during the testing or alternatively take a break between tests. A subject fatigue warning will appear after 8 manoeuvres and the maximum number of allowed manoeuvres in one session is 20.
  9. All spirometry standards recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph Compact should never be outside accuracy limits. In normal use, calibration traceability certification is recommended as a part of the routine annual service. Accuracy should also be checked after cleaning or disassembling the spirometer for any reason, after adjusting calibration or if the flowhead or device has been dropped.
  10. Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph.
  11. Only use the Vitalograph COMPACT with the purpose-built low voltage PowerSAFE unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the power supply is 19 volts DC
  12. Do not touch any accessible metal parts of the COMPACT and the subject simultaneously to ensure that any negligible touch currents present do not reach the patient by chance via contact by the operator.
  13. Per section 14 below 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. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. NON MEDICAL EQUIPMENT MUST BE KEPT OUTSIDE THE PATIENT ENVIRONMENT.
    Portable and mobile RF communications equipment can affect medical electrical equipment.
  14. The device is susceptible to electrostatic discharge. Occasional flickering of the screen and switching off of the device could occur. To restore function, press the on-off switch.

 

3. Main Components of the Vitalograph COMPACT




Figure 01




A
Medically Approved Power Supply 
B
Power LED
C
I/O Ports – 4 x USB, 2 x Ethernet, 2 x Serial, 1 x DVI
D
Flowhead
E
Flowhead Connection Tubing
F
Flowhead Carrier
G
Colour LCD and Touch Panel Display
H
Power Switch



 

4. Features of the Vitalograph COMPACT

The Vitalograph COMPACT Expert features include:

5. Getting the Vitalograph COMPACT Ready For Use

  1. Attach the flowhead to the Vitalograph COMPACT Expert by the dual silicone tubing (Flowhead Connection Tube). Ensure that the coloured/ribbed tapping on the flowhead is connected to the ribbed side of the connection in the housing.
  2. Only use the Vitalograph COMPACT Expert with the purpose-built low voltage PowerSAFE unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the power supply is 19 volts DC.
  3. Connect the jack plug from the power supply into the socket on the rear of the Vitalograph COMPACT Expert. Plug the mains plug into a suitable socket, operate the On/Off button on the side of the instrument and the COMPACT is ready for use.
  4. For guidance using Spirotrac on COMPACT refer to the Spirotrac User Training Manual (07402), available in the help menu on the device or on the vitalograph website.
  5. To power down the COMPACT Expert device either – 
Note: the device can be powered down by pressing and holding the on-off button but this is not recommended. Correct power-down will only be achieved if one of the two methods listed above are used.

 

6. Cleaning Instructions

6.1. Cleaning and Low Level Disinfection of the Vitalograph COMPACT

The parts of the Vitalograph COMPACT that make up the flowhead, which comes into contact with subjects being tested, require low level disinfection. The body of the device may be cleaned with an alcohol wipe.

A spirometer is not designed as a ‘sterile’ device.

A new BVF should be used with each subject to prevent cross contamination, the BVF protects both the subject and the device.

One cleaning cycle should be performed weekly.

It is recommended that the complete flowhead and flowhead connection tube be replaced annually.

Table of Cleaning/Disinfection Methods

Part Clean/Low Level  Disinfection Recommended Cleaning/Low Level Disinfection
Case Exterior Clean Wiping with a 70% isopropyl alcohol impregnated cloth.
Flowhead Tube Clean
Fleisch Element Clean
ScreenCleanFor the screen, lightly wipe the surface with cotton pad or other soft material. NOTE: DO NOT use any chemicals. DO NOT wipe in a circular motion. Strokes should be either up/down or over/back.
Flowhead Body Clean & Low Level Disinfection

See section 6.2 for disassembling and cleaning of flow head.

See section 6.3 for reassembling and low level disinfection of the flowhead

Flowhead Cone Clean & Low Level Disinfection
Flowhead End Cap Clean & Low Level Disinfection
Flow Conditioning Meshes Clean & Low Level Disinfection

6.2. Disassembling and Cleaning of the Fleisch Flowhead

  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 examine them for damage or contamination.  If they are damaged or blocked, discard and replace with new parts.
  3. To remove the flowhead body from the fleisch element, place the fleisch element on a hard, flat surface with the largest diameter at the top. Push down on the flowhead body with thumbs and forefingers until it reaches the flat surface. A final pulling and twisting action will separate the parts.

    Flowhead Assembly
    1. Flowhead Complete 
    2. 'O' rings 
    3. Flowhead End Cap 
    4. Flow Conditioning Meshes
    5. Flowhead Cones
    6. Fleisch Element 
    7. Flowhead Body 
    8. Lubrication: Silicone Grease 
    Figure 3: Flowhead Assembly
  4. To clean the fleisch element, swill vigorously in warm soapy water. Do not attempt to “rub” or “scrub” at capillaries. 
  5. To clean the flowhead end cap, flow conditioning meshes and flowhead cone, wash in warm soapy water. Rub surfaces to remove any visible soiling.
  6. Examine all parts to ensure they are visibly clean. If not visibly clean repeat the cleaning process.
  7. Rinse all parts in distilled water.
  8. Leave to dry completely before reassembling. Drying the fleisch element components may require placing them in a warm place overnight. A drying cabinet is ideal.

Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.

 

6.3. Reassembling and Low Level Disinfection of the Fleisch Flowhead

  1. Examine the Fleisch element to ensure that no liquid or particles remain in the holes, grooves or pressure tappings.
  2. Check the 'O' rings for damage and ensure that they are correctly positioned within the grooves.
  3. Apply a very small amount of silicone grease to ‘O’ Rings and inside the surfaces of the flowhead body. Wipe off any visible amounts of grease. Ensure that the tiny annular holes on the outside of the Fleisch element are not blocked.
  4. When re-assembling the flowhead, ensure that the blue pressure tapping is nearest to the largest diameter of the Fleisch element.
  5. Ensure that the flowhead body is pushed fully home and rotate it so that the pressure ports are approximately 180° opposite the end of the Fleisch element coil.
  6. Fit flow conditioning meshes to both the flowhead cone and the flowhead end cap. See figure 3, Flowhead Assembly.
  7. Push the flowhead end cap onto the larger diameter of the Fleisch element and push the flowhead cone onto the smaller diameter.
  8. Wipe all external surfaces of the flowhead with a 70% isopropyl alcohol impregnated cloth.
  9. When attaching the flowhead connection tube ensure that the matching coloured/serrated edge pressure tappings on the flowhead and the Vitalograph COMPACT are connected to each other.

IT IS RECOMMENDED THAT AN ACCURACY CHECK IS CARRIED OUT FOLLOWING REASSEMBLY TO VERIFY CORRECT OPERATION AND ACCURACY.

 

 

7. Fault Finding Guide

Problem Fault Symptoms:
  • Not measuring flow
Possible Causes:
(In probable order)
  • Ensure tubing is connected correctly. Ribbed side of the tubing should be connected to the ribbed half of the connector on the side of the device
 
Problem Fault Symptoms:
  • Incorrect or no volume measurements
Possible Causes:
(In probable order)
  • Ensure tubing is connected correctly. Ribbed side of the tubing should be connected to the ribbed half of the connector on the side of the device
  • Ensure that the connectors are clear of obstruction or dirt and that they are inserted fully
  • Ensure the tubing is not kinked or squeezed
 
Problem Fault Symptoms:
  • Excessive calibration drift
Possible Causes:
(In probable order)
  • Clean the flow head thoroughly
  • Contact the nearest dealer for replacement
 
Problem Fault Symptoms:
  • Test performed but does not show on screen
Possible Causes:
(In probable order)
  • Ensure tubing is connected between flow-head and connector on the side of the device correctly (same colour connector at both ends)
 
Problem Fault Symptoms:
  • Report does not print all tests
  • Report does not print some parameters
Possible Causes:
(In probable order)
  • Ensure the correct report settings are set-up in Tools-Options-Reports
  • Ensure the parameters you require are selected from Tools-Options-Parameters

NOTE: If a particular parameter is selected but has no measurement for any test then it will not appear on the printout

 
Problem Fault Symptoms:
  • Accuracy check variations > +/- 3%
Possible Causes:
(In probable order)
  • Recheck Calibration with reference to section Checking Accuracy
  • Was the correct syringe volume entered?
  • Ensure that the tubing connectors are clear of obstruction or dirt and that they are inserted fully
  • Ensure the tubing is not kinked or squeezed
  • Ensure flow-head is clean
 
Problem Fault Symptoms:
  • Test begins automatically
  • Volume accumulates automatically without the subject blowing
  • Very small VC or FVC test displayed
Possible Causes:
(In probable order)
  • Flowhead and/or tubing not stationary at the start of test. Hold them steady until the ‘Blow Now’ prompt appears
  • Return to Main Menu and re-enter the test routine
 


8. Customer Service

Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph.

For the names and addresses of approved Vitalograph Service Agents or to arrange a spirometry training workshop, please refer to the contact information at the start of this manual.

 

 

9. Consumables and Accessories

Cat. no Description
28350 BVF (50)
20408 1-L Precision Syringe
36020 3-L Precision Syringe
42084 Flow Conditioning Mesh (10)
67252 USB Cable
67181 COMPACT Expert 19V PowerSAFE Spare
61030 Flowhead Complete
42029SPR Flowhead Connection Tube


10. Explanation of Symbols

Type BF Equipment symbol Type BF equipment
Class symbol Class II
VA Power rating
Voltage symbol Voltage DC
Attention symbol Attention (reference relevant section in manual)
Manufacturer symbol Manufacturer
Year of manufacture symbol Year of Manufacture

Other Labels

Voltage symbol Power input connector
USB symbol USB connector
Serial symbol Serial connector
Disposal symbol The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste.

 

 

11. Technical Specifications

Product Vitalograph COMPACT
Model 6600
Flow detection principle Fleisch type pneumotachograph
Back pressure

Less than 0.1kPa/L/second @ 14L/s, complies with ISO26782:2009

Volume detection Flow integration sampling @ 100Hz
Maximum test duration 90 seconds
Maximum displayed volume 10L
Volume accuracy ±3% or 0.05L
Max. Volume 9.99L
Min. Volume 0.01L
Linearity Better than ±3%
Voltage/Frequency 110-240 V; approximately 50/60 Hz
Accuracy when operated in operating temperature range conditions

Flow ±10% or 0.3 L/s
Max. flow rate ±16 L/s
Min. flow rate ±0.02 L/s

Operating temperature range

ATS/ERS:2005 Guidelines: 17–37ºC
Design limits: 10–40ºC

Performance standards the Vitalograph COMPACT Expert meets or exceeds ISO 23747:2009, ISO 26782 2009, ATS/ERS 2005
Safety standards EN ISO 60601:2006 (IEC 60601-1:2005)
QA/GMP standards

EN ISO 13485:2003, FDA 21 CFR 820, CMDR SOR/98-282 & JPAL

Size 375 mm x 235 mm x 110 mm
Weight

2.5 kg net

Storage Temperature 0–50°C
Storage Relative Humidity 10%–95%
Printer External
Communications USB x minimum 4, Serial x 2, Ethernet x 2, DVI
Software Vitalograph Model 7000 Spirotrac
User Training Manual 07402
510K K141546  

Note:

  • All lung function measurement values displayed by the Vitalograph COMPACT Expert are expressed in BTPS.
  • Take care not to block the mouthpiece with the tongue or teeth. A ‘spitting' action or coughing will give false readings.
  • Time zero is determined using the back-extrapolated method, from the steepest part of the curve.


12. CE Notice

Marking by the symbol CE mark indicates compliance of the Model 6600 Vitalograph COMPACT Expert to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph COMPACT Expert meets or exceeds the following technical standards:

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.

Guidance and manufacturer’s declaration – electromagnetic emissions
The Model 6600 COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of Model 6600 COMPACT should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The Model 6600 COMPACT 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 Model 6600 COMPACT 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

 

Guidance and manufacturer’s declaration – electromagnetic immunity
The Model 6600 COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6600 COMPACT 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

±2kV, ±4kV, ±6kV contact

±2kV, ±4kV, ±8 kV air

±6kV 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%. In the case of an ESD event over the compliance level occuring, a switch back on restores the EUT to normal operation.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV

N/A for input/output lines of Compact as lines are less than 3m.
 
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
 
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
A

A

A

C
Mains power quality should be that of a typical commercial or hospital environment.
If the user of the Model 6600 COMPACT requires continued operation during power mains interruptions, it is recommended that the Model 6600 COMPACT be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m 3A/m  

In the case of an ESD event over the compliance level occuring, a switch back on restores the EUT to normal operation.

 

Guidance and manufacturer’s declaration – electromagnetic immunity
The Model 6600 COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6600 COMPACT 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

 

 

 

 

3 Vrms
150kHz to 80
MHz in ISM bands

 

3 V/m
80 MHz to 2,5
GHz

 

 

 

 

3Vrms from
150kHz to
80MHz

 

3V/m from
80MHz to
2.5 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the Model 6600 COMPACT, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d= 1.2 √ P 80MHz to 800MHz

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:

Interderence

 

 

Recommended separation distances between portable and mobile RF communication equipment and the Vitalograph COMPACT Expert
The Model 6600 COMPACT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the COMPACT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the COMPACT 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
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
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 3.8m 3.8m 7.3m
100 12m 12m 23m
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.

 

13. FDA Notice

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


14. Declaration of Conformity

Product: Model 6600 COMPACT

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:

CE mark

  • 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.

    Managing director's signature

    B. R. Garbe.

    Group Managing Director


    15. 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.