Care Fusion SpiroUSB Operating Manual Issue 1.0 Oct 2009

SpiroUSB Operating manual I. Introduction - English The SpiroUSB is a PC connected spirometer dedicated to work with the comprehensive Spirometry PC Software (SPCS). SPCS is a fully Windows™ compatible spirometry system that interfaces seamlessly with the SpiroUSB providing many display options and includes powerful reporting and database facilities. SPCS has many advanced features including display of real time respiratory traces, predicted values, patient database, and the ability to carry out pre and post bronchodilator and post steroid testing. The SpiroUSB uses the CareFusion Digital Volume Transducer, an extremely stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.

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Package contents The SpiroUSB is packaged in a sturdy carrying case containing this manual and the following items (Fig.1): 1. Carefusion Digital Volume Transducer 2. SpiroUSB transducer housing. Together with SPCS, extension cable, disposable cardboard mouthpieces and nose clip. Please note: The SpiroUSB should only be connected to a computer that has been manufactured in accordance with EN60950 1992/1993 – ‘Safety of Information Technology Equipment including Electrical Business Equipment’.

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2

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Installing SPCS SPCS is supplied on CD ROM with your SpiroUSB. Install SPCS according to the instructions in the SPCS quick start guide.

Installing SpiroUSB device driver The driver enables CareFusion Ltd USB devices to work with USB enabled PC software on Windows based machines.

Compatibility status There are two versions of the USB driver. The driver used depends on the Operating System you are using. There is a driver for Windows 2000/XP Operating Systems. The following operating systems are supported: • Windows 2000 Professional service pack 4 • Windows XP Home Edition • Windows XP Professional • Windows Vista The driver will not be supported under Windows 95, Windows 98 Gold (First Edition), Windows 98SE (Second edition), Windows ME (Millennium edition) or Windows NT 4.0 Workstation, as USB is not officially supported on these Operating Systems.

Driver installation – Windows 2000/XP/Vista Windows 2000, Windows XP and Windows Vista support preinstallation of drivers. If software is installed that provides support for USB, the drivers may be pre-installed, allowing automatic installation of the drivers when the device is connected to the USB port. If the device does not install automatically, follow the steps to install the device manually. 7

Operation Simply connect the SpiroUSB to a spare USB port on your PC with the supplied SPCS installed. SPCS will automatically detect that the SpiroUSB has been connected to a USB port and will run, ready for you to start your spirometry session. There is no need to remove the SpiroUSB between sessions. Please note that with certain PC configurations, even if a compatible operating system is being used, SPCS may not be launched automatically when the SpiroUSB is plugged in. In this case SPCS may be run in the usual way using the Windows on-screen Start button. The SpiroUSB transducer is supplied with a two-meter cable. If this length is insufficient then a remote USB hub should be used. Remote USB hubs are readily available from computer accessory suppliers. For some recent computers the USB signal will work over a longer distance using an extension cable. An extension cable has been supplied for your convenience, if required. If communication problems are encountered using the extension cable then a remote USB hub must be used.

Looking after your SpiroUSB Spirometer Please observe the following precautions: •

Avoid exposing the SpiroUSB to direct sunlight during use.

•

Avoid operating the spirometer in dusty conditions or near to heating appliances or radiators.

•

Do not keep the spirometer in a damp place or expose it to extremes of temperature.

•

Do not direct the transducer holder towards a strong light source whilst operating the spirometer.

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Cleaning the Transducer The transducer requires no routine maintenance or servicing. However, if you wish to sterilise or clean the transducer it may be removed by means of the following procedure: 1. Rotating the turbine transducer anti-clockwise until the locating pip lines up with the small rectangular cut-out in the housing as shown below. 2. Gently pull the transducer away from the housing. 3. The transducer may now be immersed in warm soapy water for routine cleaning or immersed in a cold sterilising solution e.g. Perasafe for a maximum of 10 minutes (Alcohol and chloride solutions should be avoided). After cleaning/sterilising, the transducer should be rinsed briefly in distilled water and dried. Perasafe is available from CareFusion in convenient 81g containers, Cat No. 36-ACC1013. 4. Re-assemble the mouthpiece holder.

Housing

Turbine transducer

Cut-Out

Locating Pip

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Servicing A full service manual including circuit diagrams and parts list is available upon request.

Symbols Type B device

In accordance with Directive 93/42/EEC 0086

Disposal in compliance with WEEE

Environment This instrument complies with directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding levels specified in EN 50082-1:1992

Electrical classification Class I equipment.

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Consumables/supporting products Cat. No.

Description

36-PSA1000

Adult Disposable Mouthpieces (500 per box)

36-SST1000

One-way Safety Mouthpieces (500 per box)

36-PSA1200

Paediatric Disposable Mouthpieces (250 per box)

36-PSA1100

Paediatric Adaptor

36-MGF1025

MicroGard Pulmonary Filters (25 per box)

36-MGF1100

MicroGard Pulmonary Filters (100 per box)

36-ACC1013

PeraSafe Sterilising Powder 81g (to make up 5 litres of solution)

36-VOL2104

Nose Clips (pack of 5)

36-SM2125

3 Litre Calibration Syringe

36-ASS1042

SpiroUSB desktop stand

Caution •

Pulmonary filters are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may increase air resistance and lead to an incorrect measurement.”

•

Mouthpieces are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may degrade materials and lead to an incorrect measurement.”

Training CareFusion run spirometry training courses throughout the UK, sessions include: * Anatomy and Physiology of Respiratory System * Lung Volume Terminology * Objectives of Spirometry * Setting up the test & performing a good manoeuvre * Errors of technique 11

* Interpretation of results * Using Spirometry as an aid to diagnosing airways disease * Choosing a Spirometer * Case Studies

Specification of the SpiroUSB General Power supply:

Input 5V 0.1A

Dimensions:

50x60x90mm.

Weight:

130g

Operating Temperature:

0 to +40° C

Operating Humidity:

30% to 90% RH

Storage Temperature:

-20 to + 70° C

Storage Humidity:

10% to 90% RH

Predicted Values:

Various – depends upon national preference.

Transducer:

Carefusion Bi-Directional Digital Volume.

Resolution:

10ml volume 0.03l/s flow

Accuracy:

+/-3%. To ATS recommendations – Standardisation of spirometry 1994 update for flows and volumes.

Measurements:

See SPCS operating manual for details of all the spirometry measurements available.

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SpiroUSB Operating manual

Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner.

CareFusion, 22745 Savi Ranch Parkway, Yorba Linda CA 92887-4668 USA

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II. Introduction – CareFusion USA The SpiroUSB is a PC connected spirometer dedicated to work with the comprehensive Spirometry PC Software (SPCS). SPCS is a fully Windows™ compatible spirometry system that interfaces seamlessly with the SpiroUSB providing many display options and includes powerful reporting and database facilities. SPCS has many advanced features including display of real time respiratory traces, predicted values, patient database, and the ability to carry out pre and post bronchodilator and post steroid testing. The SpiroUSB uses the Digital Volume Transducer, an extremely stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections.

This transducer is insensitive to the effects of

condensation and temperature and avoids the need for individual calibration prior to performing a test. The SpiroUSB utilizes a single patient use disposable mouthpiece that must be disposed of after use The SpiroUSB provides a suggested interpretation that must be supported by clinical judgement.

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Package Contents The SpiroUSB is packaged in a sturdy carrying case containing this manual and the following items (Fig.1): 1.

Carefusion Digital Volume Transducer

2.

SpiroUSB transducer housing.

Together with SPCS software, extension cable, disposable cardboard mouthpieces and nose clip. Please note: The SpiroUSB should only be connected to a computer that has been manufactured in accordance with EN60950 1992/1993 – ‘Safety of Information Technology Equipment including Electrical Business Equipment’.

1

2

15

Installing SPCS SPCS is supplied on CD ROM with your SpiroUSB.

Install SPCS

according to the instructions in the SPCS quick start guide.

Installing SpiroUSB Device Driver The driver enables USB devices to work with USB enabled PC software on Windows based machines.

Compatibility Status There are two versions of the USB driver. The driver used depends on the Operating System you are using.

There is a driver for

Windows 2000/XP Operating Systems. The following operating systems are supported: •

Windows 2000 Professional

•

Windows XP Home Edition

•

Windows XP Professional

Driver Installation – Windows 2000/XP Windows 2000, Windows XP and Windows Vista support preinstallation of drivers. If software is installed that provides support for USB, the drivers may be pre-installed, allowing automatic installation of the drivers when the device is connected to the USB port. If the device does not install automatically, follow the steps to install the device manually.

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Operation Simply connect the SpiroUSB to a spare USB port on your PC with the supplied SPCS software installed. SPCS will automatically detect that the SpiroUSB has been connected to a USB port and will run, ready for you to start your spirometry session. There is no need to remove the SpiroUSB between sessions. Please note that with certain PC configurations, even if a compatible operating system is being used, SPCS may not be launched automatically when the SpiroUSB is plugged in. In this case SPCS may be run in the usual way using the Windows on-screen Start button. The SpiroUSB transducer is supplied with a two-meter cable. If this length is insufficient then a remote USB hub should be used. Remote USB hubs are readily available from computer accessory suppliers. For some recent computers the USB signal will work over a longer distance using an extension cable. An extension cable has been supplied for your convenience, if required. If communication problems are encountered using the extension cable then a remote USB hub must be used.

Looking after your SpiroUSB Spirometer Please observe the following precautions: •

Avoid exposing the SpiroUSB to direct sunlight during use.

•

Avoid operating the spirometer in dusty conditions or near to heating appliances or radiators.

•

Do not keep the spirometer in a damp place or expose it to extremes of temperature.

•

Do not direct the transducer holder towards a strong light source whilst operating the spirometer.

17

Cleaning the Transducer The transducer requires no routine maintenance or servicing. However, if you wish to sterilise or clean the transducer it may be removed by means of the following procedure: 1. Rotating the turbine transducer anti-clockwise until the locating pip lines up with the small rectangular cut-out in the housing as shown below. 2. Gently pull the transducer away from the housing. 3. The transducer may now be immersed in warm soapy water for routine cleaning or immersed in a cold sterilising solution e.g. Perasafe for a maximum of 10 minutes (Alcohol and chloride solutions should be avoided). After cleaning/sterilising, the transducer should be rinsed briefly in distilled water and dried. Perasafe is available from in convenient 81g containers. 4. Re-assemble the mouthpiece holder.

Housing Turbine transducer

Cut-out

Locating pip

18

Servicing A full service manual including circuit diagrams and parts list is available upon request. For US Customer Care: Toll Free 1-800-231-2466, phone 1-714283-2228

Symbols Type B device

In accordance with Directive 93/42/EEC 0086

Disposal in compliance with WEEE

Environment This

instrument

complies

with

directive

EN60601-1-2

electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding levels specified in EN 50082-1:1992

Electrical classification Class I equipment.

19

Consumables / Supporting Products Cat. No.

Description

36-PSA1000

Adult Disposable Mouthpieces (500 per box)

36-SST1000

One-way Safety Mouthpieces (500 per box)

36-PSA1200

Paediatric Disposable Mouthpieces (250 per box)

36-PSA1100

Paediatric Adaptor

36-MGF1025

MicroGard Pulmonary Filters (25 per box)

36-MGF1100

MicroGard Pulmonary Filters (100 per box)

36-ACC1013

PeraSafe Sterilising Powder 81g (to make up 5 litres of solution)

36-VOL2104

Nose Clips (pack of 5)

36-SM2125

3 Litre Calibration Syringe

36-ASS1042

SpiroUSB desktop stand

To place an order for consumables / supporting products, or for general enquiries please contact CareFusion or your local CareFusion dealer.

Caution •

Pulmonary filters are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may increase air resistance and lead to an incorrect measurement.”

•

Mouthpieces are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may degrade materials and lead to an incorrect measurement.”

20

Specification of the SpiroUSB General Power supply:

Input 5V 0.1A

Dimensions:

50x60x90mm.

Weight:

130g

Operating Temperature:

0 to +40° C

Operating Humidity:

30% to 90% RH

Storage Temperature:

-20 to + 70° C

Storage Humidity:

10% to 90% RH

Predicted Values:

Various – depends upon national preference.

Transducer:

Carefusion Bi-Directional Digital Volume.

Resolution:

10ml volume 0.03l/s flow

Accuracy:

+/-3%. To ATS recommendations – Standardisation of spirometry 1994 update for flows and volumes.

Measurements:

See software operating manual for details of all the spirometry measurements available.

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Customer contact information UK Customers only For all Sales Order processing for products, training and spare parts, Service and Technical Support enquiries, please contact the following: CareFusion UK 232 Ltd UK Customer Service & Support The Crescent Jays Close Basingstoke RG22 4BS Customer Service Sales Enquiries: Telephone: 01256 388550 Email:

[email protected]

Factory Repair and Administration Enquiries: Telephone: 01256 388552 Email:

[email protected]

Technical Support Enquiries: Telephone: 01256 388551 Email:

[email protected]

International customers only For all Sales Order processing for products and Spare parts, Service and Technical Support enquiries, please contact the following: Carefusion Germany 234 GmbH Customer Service & Support International Leibnizstrasse 7 97204 Hoechberg Germany

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Customer Service Sales Enquiries: Telephone: 0049 931 4972 670 Email:

[email protected]

Factory Repair and Administration Enquiries: Telephone: 0049 931 4972 867 Email:

[email protected]

Technical Support Enquiries: Telephone: 0049 931 4972 127 Email:

[email protected]

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