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Vitalograph logo
Pneumotrac

Model 6800

User Training Manual

 

CE


 

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 Straße 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.
Phone: (913) 730-3200
Fax: (913) 730-3232
e-mail: vitcs@vitalograph.com
www.vitalograph.com

Manufacturer symbol 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 2013
Current Edition (Issue 9)
Cat. No. 07147

Vitalograph logo is a registered trademark

 


Table of Contents

  1. DESCRIPTION OF THE VITALOGRAPH PNEUMOTRAC
  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

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.

 

 

2. Main Components of the Vitalograph Pneumotrac


A
Vitalograph Pneumotrac device
B
Flowhead
C
Twin tubing




 

3. Features of the Vitalograph Pneumotrac

The Vitalograph Pneumotrac’s features include:

 

 

 

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.

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 (usually marked with the USB Symbol symbol).

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.)

  1. Unwrap the white twin 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.
  2. Unwrap the flowhead from its packaging and connect the other end of the twin tubing to it. Ensure that the ribbed side of the tubing is connected to the blue tapping on the flowhead connector.
  3. Take one of the flowhead filters from its packaging and place in the flowhead holder on the Vitalograph Pneumotrac device.
  4. 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.
  5. 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

A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.

It is recommended that the flowhead be regularly cleaned according to the guidelines of the user’s facility.

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 also be replaced in the event of damage, or if visibly contaminated.

The frequency of cleaning and disinfecting is dependent on the Facility’s Risk Assessment, usage, and test environment, but it should be at least monthly or every 100 subjects (500 blows).

It is recommended that the flowhead—flowhead complete 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.

Part Material Clean/ Disinfect Autoclave Recommended Disinfectants
Case Exterior ABS Clean No

Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary.

White Flowhead Tube Silicone Rubber Clean Viable
Fleisch Element Aluminium, Stainless Steel Clean Viable Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes (see following section for recommended cleaning/disinfection method for the Vitalograph Pneumotrac Flowhead) The flowhead may also be disinfected by autoclaving at 134°C for 3 minutes or 120°C for 20 minutes.
Flowhead Body Aluminium & Acetyl Clean & Disinfect No
Flowhead Cone TPX Clean & Disinfect Viable
Flowhead End Cap TPX Clean & Disinfect Viable
Flow Conditioning Meshes Acetyl and Polyester Dispose No

All 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.

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 discard them.
  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 – 61030
    2. 'O' rings - 2120013
    3. Flowhead End Cap -62006SPR
    4. Flow Conditioning Meshes - 42084
    5. Flowhead Cone - 62019SPR
    6. Fleisch Element - 62055SPR
    7. Flowhead Body – 61020
    8. 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 new 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 coloured/serrated edge pressure tappings on the flowhead and the Vitalograph Pneumotrac are connected to each other.
  9. 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 blue tapping 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, 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

Cat. no

Description

20242

SafeTway Mouthpieces (200)

20303

Nose Clips (200)

28350

BVF - Bacterial/Viral Filters (50)

20408

1-L Precision Syringe

36020

3-L Precision Syringe

79158

Flow Cone (10)

42084

Flow Conditioning Mesh (10)

61030

Flowhead Complete

67252

USB Cable

76050

Filters (50) and Tweezers

 


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

Other Labels

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

45 seconds

Maximum displayed volume

10 L

Volume accuracy

Better than ±3%

Voltage/Frequency

110-250 V; approximately 50/60 Hz

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: 17–37ºC
Design limits: 10–40ºC

Performance standards the Vitalograph Pneumotrac meets or exceeds

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

Safety standards

EN ISO 60601

QA/GMP standards

EN ISO 23747:2007, EN ISO 26782:2009 & FDA 21CFR820

Size

170 mm x 163 mm x 45 mm

Weight

345g

Storage Temperature

0–50ºC

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

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The [equipment or system] 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 [A]

 

Harmonic emissions
IEC 61000-3-2

Class [A]

 

Voltage Fluctuations/Flicker emissions
IEC61000-3-3

[Complies]

 

The [equipment or system] 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 system is intended for use in the electromagnetic environment specified below. The customer or the user of the system 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

±6 kV contact
±8 kV air

Complies

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

Complies

Mains power quality should be that of a typical commercial or hospital environment

Surge
IEC 61000-4-5

±1kV differential mode
±2 kV common mode

Complies

Mains power quality should be that of a typical commercial or hospital environment

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

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the system requires continued operation during power mains operation, it is recommended that the system be powered from an uninterruptible power supply or battery

Power frequency
(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m

 

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

Note: Ut is the a.c.mains voltage prior to application of the test level

 

Guidance and manufacturer’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system 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

 

3 V/m
80 MHz to 2.5 GHz

 

 

 

 

 

 

 

 

 

 

 

[3]V

 

 

[3]V/m

 

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 = [3.5/ 3]√P

 

 

d = [3.5/ 3]√P…80MHz to 800 MHz

d = [7/ 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 metres (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 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.  The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system 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 = [3.5/ 3]P

80 MHz to 800 MHz
d = [3.5/ 3]P

800 MHz to 2.5GHz
d = [7/ 3]P

0.01

 

 

 

0.1

 

 

 

1

 

 

 

10

 

 

 

100

 

 

 

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.

 

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.