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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, V95 HFT4
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 5)
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.

Note:

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.


    NOTE: 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. When used together with a BVF, a longer replacement interval can be expected. Flowhead and tubing must be replaced if damage is evident or if cleaning does not remove visible soiling.

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

See section 7.2 for disassembling and cleaning of flow head.

See section 7.3 for reassembling and low level disinfection of the flowhead

Flow Conditioning Meshes Clean
Flowhead Body Clean & Low Level Disinfection
Flowhead Cone Clean & Low Level Disinfection
Flowhead End Cap 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 blue tapping/ribbed connector side of the flowhead body furthest away from the flat surface. 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.To clean the fleisch element, swill vigorously in warm soapy water. Do not attempt to ?rub? or ?scrub? at capillaries.