Vitalograph logo
Pneumotrac

Model 6800

User Training Manual

 

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 Stra?e 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 2015
Current Edition (Issue 4)
Cat. No. 07671

Vitalograph logo is a registered trademark

 


Table of Contents

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

 


 

Figure 1

Figure 1

 


 

 

1. Description of the Vitalograph Pneumotrac

The Vitalograph Pneumotrac in association with the Spirotrac PC based software is a spirometer designed for lung function testing in a variety of environments, e.g. hospital wards, occupational health centers and private homes. The Vitalograph Pneumotrac device is designed for desktop use with communications capability in order to connect with the Spirotrac. The long proven Fleisch flowhead is used for testing and has a resting location on the device.

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

Warning: No modification of this equipment is allowed. Any unauthorised changes to the Pneumotrac 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 device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF,  MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

2. Contraindications and Precautions for use

  1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph Pneumotrac 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 Pneumotrac 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 Pneumotrac 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 Pneumotrac 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. When the Pneumotrac device is used with Spirotrac 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 Pneumotrac 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. 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.
  12. When using the Vitalograph Pneumotrac in conjunction with Spirotrac if you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 part 1-1 regulations and to your EN specifications e.g. EN60950 for data equipment, EN60601 for medical equipment. Non medical equipment must be kept outside the patient environment ie. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching part of the system, can occur.

3. Main Components of the Vitalograph Pneumotrac


1
Flowhead
2
Flowhead Connection Tubing
3 Flowhead Carrier
4 USB Connector (connect to P.C with USB cable)
5
Power LED




 

4. Features of the Vitalograph Pneumotrac

The indications for use of the Vitalograph Pneumotrac (in conjunction with Spirotrac) is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and control of chest diseases. 

Spirometry may support or exclude diagnosis, but it cannot make one. Spirometers are also used in non-clinical settings such as occupational health screening where no clinical judgment is made, suspect findings always leading to a referral to a clinician

 

5. Getting the Vitalograph Pneumotrac 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. If the device has just been unpacked or transported, ensure that it is left sitting, fully powered, in its test environment for at least an hour before use.

The following simple steps need to be carried out to get the Vitalograph Pneumotrac ready for use.

Attention

For safety, it is recommended that the PC is fully powered off before you start this procedure.

  1. Plug one end of the USB cable into an available USB port at the back of the PC (usually marked with the USB Symbol symbol).
  2. Plug the other end of the USB cable into the USB port at the side of the Vitalograph Pneumotrac (marked with the USB Symbol symbol).
  3. When power is applied to the device the green power LED on the front will turn on.

    Attention


    IF YOU CONNECT ADDITIONAL EQUIPMENT (NOT PRODUCED BY VITALOGRAPH) TO THE USB INTERFACE PORT, IT MUST CONFORM TO VDE0750 PART 1-1 REGULATIONS AND TO YOUR EN SPECIFICATIONS, EG. EN60950 FOR DATA EQUIPMENT, EN60601 FOR MEDICAL EQUIPMENT. NON MEDICAL EQUIPMENT MUST BE KEPT OUTSIDE THE PATIENT ENVIRONMENT IE. ANY AREA IN WHICH INTENTIONAL OR UNINTENTIONAL CONTACT BETWEEN THE PATIENT AND PARTS OF THE SYSTEM, OR SOME OTHER PERSONS TOUCHING PARTS OF THE SYSTEM, CAN OCCUR.

    (CONTACT YOUR DISTRIBUTOR IF YOU HAVE ANY QUERIES.)

  4. Unwrap the flowhead connection tubing from its packaging and connect one end to the Vitalograph Pneumotrac device. Ensure that the ribbed side of the tubing is connected to the ribbed half of the connector. If tubing is connected the wrong way, spirometry results may appear to be inverted.
  5. Unwrap the flowhead from its packaging and connect the other end of the flowhead connection tubing to it. Ensure that the ribbed side of the tubing is connected to the ribbed half of the connector. If tubing is connected the wrong way, spirometry results may appear to be inverted.
  6. The Vitalograph Pneumotrac device is now ready for use. The Spirotrac software must be installed on the PC to begin testing. Refer to the Spirotrac instructions for details.
  7. The USB driver must be installed on the PC to begin testing. 

6.   OPERATING THE VITALOGRAPH PNEUMOTRAC WITH SPIROTRAC V

  1. The Vitalograph Pneumotrac works in association with Vitalograph Spirotrac software. The Spirotrac software and the USB driver for the Pneumotrac must be installed on the PC to begin testing. Refer to the Spirotrac User Training Manual 07402, Section 4: "Getting Vitalograph Spirotrac ready for use" for details on -
  1. For details on setting up Spirotrac prior to Spirometry testing refer to the Spirotrac User Training Manual 07402, Section 5: "Operating Vitalograph Spirotrac". This section includes information on (but is not restricted to) - 
  1. For details on spirometry testing using Spirotrac refer to the Spirotrac User Training Manual 07402, Section 6: "Testing using Spirotrac" . This section includes information on (but is not restricted to) -

 

7. Cleaning Instructions

7.1. Cleaning and Low Level Disinfection of the Vitalograph Pneumotrac

The parts of the Vitalograph Pneumotrac 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
Flowhead Body Clean & Low Level Disinfection

See section 7.2 for disassembling and cleaning of flow head.

See section 7.3 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

7.2. 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 Cone 
    6. Fleisch Element 
    7. Flowhead Body
    8. Lubrication: Silicone Grease
    Figure 2: 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.

 

7.3. 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 2, Flow head 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 serrated edge pressure tappings on the flowhead and the Vitalograph Pneumotrac are connected to each other
It is recommended that an accuracy check is carried out following reassembly to verify correct operation and accuracy.

 

 

8. Fault Finding Guide

Problem Fault Symptoms:

  • Accuracy check variations > +/-3%
  • False readings suspected

Possible Causes: (In probable order)

  • Recheck Calibration with reference to section Checking Accuracy
  • Was the correct syringe volume selected?
  • An accuracy check is required after cleaning/disinfecting the flowhead fleisch element assembly.
  • Flowhead cone fleisch element filter mesh missing or blocked.
  • Flowhead body pressure port holes blocked.
  • Flowhead fleisch element assembly sealing ‘O’ rings damaged.
  • Flowhead fleisch element assembly not dried thoroughly.
  • Flowhead fleisch element assembly blocked.
  • Flowhead body tubing from pressure ports to main PCB blocked – contact support.
  • Main PCB failure – contact support.

 

 

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 ‘Ready to Blow’ prompt appears.
  • Return to Main Menu and re-enter the test routine.

 

 

Problem Fault Symptoms:

  • Rocking device.

Possible Causes: (In probable order)

  • Check for damaged or missing rubber feet.
  • If any of the rubber feet are damaged or missing replace all rubber feet.

 

 

Problem Fault Symptoms:

  • Reversed 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 Vitalograph Pneumotrac device and the ribbed half of the connector on the flowhead connector
  • Ensure that the flowhead connecting tube is not pinched or trapped.

 

 

 


9. 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 spirometry workshops, please refer to the contact information at the start of this manual.

 

 

10. Consumables and Accessories

Cat. no

Description

28350

BVF - Bacterial/Viral Filters (50)

20408

1-L Precision Syringe

36020

3-L Precision Syringe

42084

Flow Conditioning Mesh (10)

61030

Flowhead Complete

67252

USB Cable

 


11. 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
USB symbol USB 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.

 

 

12. Technical Specifications

Product

Vitalograph Pneumotrac

Model

6800

Flow detection principle

Fleisch type pneumotachograph

Back pressure

Less than 0.1kPa/L/second @ 14L/s, complies with ATS/ERS 2005

Volume detection

Flow integration sampling @ 100Hz

Maximum test duration

90 seconds

Maximum displayed volume

10 L

Volume accuracy

Better than ?3%

Voltage/frequency

5V USB power

Accuracy when operated in operating temperature range conditions

Flow ?10%
Max. flow rate ?16 L/s
Min. flow rate ?0.02 L/s

Operating temperature range

ATS/ERS limits: 17–37?C
Design limits: 10–40?C

Performance standards the Vitalograph Pneumotrac meets or exceeds

ATS/ERS 2005, ISO 23747:2007 & ISO 26782:2009

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


103mm x 185mm

Weight

450g

Storage Temperature

0–50?C

Storage Relative Humidity

10%–95%

Communications

USB

Notes:

  • All values displayed are expressed as BTPS values.
  • 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.

 


13. CE Notice

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

Guidance and manufacturer’s declaration – electromagnetic emissions

The Model 6800 Pneumotrac is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6800 Pneumotrac should assure that it is used in such an environment. 

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The Model 6800 Pneumotrac 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

N/A as USB powered

 

Harmonic emissions
IEC 61000-3-2

N/A as USB powered

 

Voltage Fluctuations/Flicker emissions
IEC61000-3-3

N/A as USB powered

 

The Model 6800 Pneumotrac is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

 

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model 6800 Pneumotrac is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6800 Pneumotrac 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%.

Electrical fast transient/burst

IEC 61000-4-4

?2kV for power supply lines
?1 kV for input/output lines

N/A as not connected to mains, USB powered.

Surge
IEC 61000-4-5

?1kV differential mode
?2 kV common mode

N/A as not connected to mains, USB powered.


Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5 % Ut
(>95 % dip in Ut)
for 0.5 cycle

40 % Ut
(60% dip in Ut)
for 5 cycles

70 % Ut
(30 % dip in Ut)
for 25 cycles

<5 % Ut
(>95 % dip in Ut)
for 5 sec

N/A as not connected to mains, USB powered.

If the user of the Model 6800 Pneumotrac requires continued operation during power mains interruptions, it is recommended that the PC/laptop used be powered from an uninterruptible power supply or a battery.

Power frequency
(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m

 3 A/m


 

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model 6800 Pneumotrac is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6800 Pneumotrac 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
150 kHz to 80 MHz in ISM band

 

3 V/m
80 MHz to 2.5 GHz

 

 

 

 

 

 

 

 

 

 

 

N/A as USB powered

 


[3]V/m from 80MHz to 2.5GHz

 

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, 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 800 MHz

d = 2.3√P…800 MHz 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 meters (m)
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol

Interference

Note 1: At 80 MHz and 800 MHz, 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.

 

a

 

 

 

 
b

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the system.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3]V/m

 

Recommended separation distances between portable and mobile RF communication equipment and the system

The Model 6800 Pneumotrac is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.  The customer or the user of the Model 6800 Pneumotrac can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model 6800 Pneumotrac 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 = 1.2P

80 MHz to 800 MHz
d = 1.2P

800 MHz to 2.5GHz
d = 2.3P

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 meters (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.

 

14. FDA Notice

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

 


 

15. Declaration of Conformity

Product: 6800 Vitalograph Pneumotrac

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:

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


 

16. Guarantee

Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its option 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 it was purchased for advice. The Company does not authorize 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.