Pneumotrac

Model 6800

User Training Manual

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

Export Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: +44 1280 827120
Fax: +44 1280 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph GmbH
Rellinger Stra?e 64a, 20257 Hamburg, Germany
Phone: (040) 54 73 91-0
Fax: (040) 547 391 40
e-mail: info@vitalograph.de
www.vitalograph.de

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

Vitalograph (Irl.) Ltd.
Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6864100
Fax: (065) 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie

? Copyright Vitalograph 2014
Current Edition (Issue 1)
Cat. No. 07671

is a registered trademark

Table of Contents

1. DESCRIPTION OF THE VITALOGRAPH PNEUMOTRAC 
1. Indications for use
   
2. MAIN COMPONENTS OF THE VITALOGRAPH PNEUMOTRAC
3. FEATURES OF THE VITALOGRAPH PNEUMOTRAC
4. GETTING THE VITALOGRAPH PNEUMOTRAC READY FOR USE
5. OPERATING THE VITALOGRAPH PNEUMOTRAC WITH SPIROTRAC V
   
6. SPIROTRAC SOFTWARE INSTALLATION
7. CLEANING INSTRUCTIONS
   1. Cleaning and Disinfecting the Vitalograph Pneumotrac
   2. Disassembling the Fleisch Flowhead
   3. Reassembling 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

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 centres and private homes. The Vitalograph Pneumotrac device is designed with desktop ease of use in mind – tidy desktop unit with state of the art communications capability in order to co-ordinate with 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 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. Its primary functions are;

1. Stand alone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FIVC, FVC) and it’s subdivisions, In- and Expiratory Flow rates (PEF, FEFx, etc), and Pre-post testing (e.g. B.D.).
2. Display a single subject’s demographic data entered by the user.
3. Produce reports, typically with measured spirometry data compared against predicted values (Z-score and %Pred).

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 judgement is made, suspect findings always leading to a referral to a clinician. 

2. Main Components of the Vitalograph Pneumotrac

3. Features of the Vitalograph Pneumotrac

The Vitalograph Pneumotrac’s features include:

• Low cost, simple PC spirometry solution

• Small, simple, accurate & robust spirometry hardware

• Interactive, friendly & adaptable software for full automation

• Unique hygiene features, simple disassembly & autoclaveable

• Standardised communication with other databases & hardware

• Proven specialised spirometry features, test QA and trending

4. 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.

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

   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. Refer to the USB driver instructions for details.

5. OPERATING THE VITALOGRAPH PNEUMOTRAC WITH SPIROTRAC V

Refer to the Help Files on Spirotrac V for information on operating the Vitalograph Pneumotrac with Spirotrac V.

6. SPIROTRAC SOFTWARE INSTALLATION

Refer to the Spirotrac V CD for information on installing the Vitalograph Spirotrac V software.

7. Cleaning Instructions

7.1. Cleaning and Disinfecting the Vitalograph Pneumotrac

External parts of the Vitalograph Pneumotrac require cleaning, i.e. the removal of visible particulate contamination. The parts of the Vitalograph Pneumotrac that make up the flowhead, which comes into contact with subjects being tested, also require disinfecting. A spirometer is not designed as a ‘sterile’ device.

For spirometry testing a new mouthpiece should be used for each subject (either SafeTway or BVF).  Vitalograph recommends use of a BVF to protect both device and subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.

In the event of visible contamination of the flowhead cones or flowhead element, they should be cleaned or disinfected as described in the accompanying table. The flowhead conditioning meshes should be replaced in the event of damage, or if visibly contaminated/blocked.

Where a BVF is used, the flowhead cone and front flowhead conditioning mesh should be cleaned and disinfected at least monthly or every 100 subjects (500 blows).  The frequency and extent of cleaning and disinfecting of the flowhead is dependent on the Facility's Risk Assessment, usage and test environment.

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

Table of Materials Used & Cleaning/Disinfection Methods

This listing of materials used is given to provide users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.

Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996”.

Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical Disinfection In Hospitals 1993”.

7.2. Disassembling 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.
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 Complete – 61030 'O' rings - 2120013 Flowhead End Cap -62006SPR Flow Conditioning Meshes - 42084 Flowhead Cone - 62019SPR Fleisch Element - 62055SPR Flowhead Body – 61020 Lubrication: Silicone Grease – 30961SPR

   Figure 2: Flowhead Assembly
   
   
4. Clean each separate part of the flowhead by washing in a mild detergent and removing particulate contamination. To clean the fleisch element, swill vigorously in water with mild detergent or use an ultrasonic bath. Do not attempt to “rub” or “scrub” at capillaries. The flowhead body (7) does not require disinfection, but may be cleaned/disinfected with the rest of the flowhead for convenience.
5. Rinse all parts in clean water.
6. Disinfect by immersion in sodium dichloroisocyanurate (NaDCC) solution at 1,000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines.
7. Rinse with very hot water to aid later drying.
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 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.
7. Push the flowhead end cap onto the larger diameter of the fleisch element and push the flowhead cone onto the smaller diameter.
8. 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.

8. Fault Finding Guide

9. 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 refer to the contact information at the start of this manual.

10. Consumables and Accessories

11. Explanation of Symbols

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

	USB connector
	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

13. CE Notice

Marking by the symbol 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:

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:

• 

  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.

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.