ADINSTRUMENTS Spirometer Owners Manual

Spirometer

Owner’s Guide

This document was, as far as possible, accurate at the time of release. However, changes may have been made to the software and hardware it describes since then. ADInstruments Pty Ltd reserves the right to alter speciﬁcations as required. Late-breaking information may be supplied separately.

Trademarks of ADInstr uments

PowerLab

, LabTutor® and MacLab® are registered trademarks of ADInstruments Pty Ltd. The names of speciﬁc recording units, such as PowerLab 8/30, are trademarks of ADInstruments Pty Ltd. LabChart, Chart and Scope (application programs) are trademarks of ADInstruments Pty Ltd.

Other Trademarks

Apple, Mac and Macintosh are registered trademarks of Apple Computer, Inc.

Windows, Windows XP and Windows Vista are either registered trademarks or trademarks of Microsoft Corporation.

All other trademarks are the property of their respective owners.

Product: ML141 Spirometer

Document Number: U-ML141-OG-003C Part Number: 4381

Web: www.adinstruments.com Technical Support: support.au@adinstruments.com Documentation: documentation@adinstruments.com

ADInstruments Pty Ltd. ISO 9001:2000 Certiﬁed Quality Management System

Reg. No. 1053

Spirometer Owner’s Guide

Safety Notes 5

1 Overview 13

How to Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Checking the Front-end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Front-end Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

The Front-end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

The Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

The Status Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

The Spirometer Input Pipes . . . . . . . . . . . . . . . . . . . . . . . . . 16

The Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

C Input and Output Sockets . . . . . . . . . . . . . . . . . . . . . . . . 16

The Analog Out Socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Equipment and Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Using the Spirometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Fitting the Flow Head. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Calibrating the Flow Head . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Reducing Drift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Contents

2 Setting Up 23

Connecting to the PowerLab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Single Front-ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Multiple Front-ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Using LabChart and Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

The Front-end Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Front-end Self-test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

The Spirometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Signal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Setting the Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Filtering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Inverting the Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Offset Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

iii

A Technical Aspects 31

Spirometer Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

B Troubleshooting 35

Problems and Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

C Specifications 39

Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Control Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Physical Conﬁguration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Index 41

Spirometer

Owner’s Guide

Safety Notes

Statement of Intended Use

All products manufactured by ADInstruments are intended for use in teaching and research applications and environments only. ADInstruments products are NOT intended to be used as medical devices or in medical environments. That is, no product supplied by ADInstruments is intended to be used to diagnose, treat or monitor a subject. Furthermore no product is intended for the prevention, curing or alleviation of disease, injury or handicap.

Safety Notes

Where a product meets IEC 60601-1 it is under the principle that:

• it is a more rigorous standard than other standards that could be chosen, and

• it provides a high safety level for subjects and operators.

The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a product:

• is a medical device,

• may be interpreted as a medical device, or

• is safe to be used as a medical device.

Safety Symbols

Devices manufactured by ADInstruments that are designed for direct connection to humans are tested to IEC 601-1:1998 (including amendments 1 and 2) and 60601-1-2, and carry one or more of the safety symbols below. These symbols appear next to those inputs and output connectors that can be directly connected to human subjects.

BF symbol: Bodyprotected equipment

The three symbols are:

• BF (body protected) symbol. This means that the input connectors are suitable for connection to humans provided there is no direct electrical connection to the heart.

• CF (cardiac protected) symbol. This means that the input connectors are suitable for connection to human subjects even when there is direct electrical connection to the heart.

• Warning symbol. The exclamation mark inside a triangle means that the supplied documentation must be consulted for operating, cautionary or safety information before using the device.

Further information is available on request.

CF symbol: Cardiacprotected equipment

Warning symbol: ‘see documentation’

Bio Amp Safety Instructions

The Bio Amp inputs displaying any of the safety symbols are electrically isolated from the mains supply in order to prevent current ﬂow that may otherwise result in injury to the subject. Several points must be observed for safe operation of the Bio Amp:

Spirometer Owner’s Guide

• All Bio Amp front-ends (except for the ML138 Octal Bio Amp) and PowerLab units with a built-in Bio Amp are supplied with a 3-lead or 5-lead Bio Amp subject cable and lead wire system. The ML138 Octal Bio Amp is supplied with unshielded lead wires (1.8 m). Bio Amps are only safe for human connection if used with the supplied subject cable and lead wires.

• All Bio Amp front-ends and PowerLab units with a built-in Bio Amp are not deﬁbrillator-protected. Using the Bio Amp to record signals during deﬁbrillator discharges may damage the input stages of the ampliﬁers. This may result in a safety hazard.

• Never use damaged Bio Amp cables or leads. Damaged cables and leads must always be replaced before any connection to humans is made.

Isolated Stimulator Safety Instructions

The Isolated Stimulator outputs of a front-end signal conditioner or PowerLab with a built-in isolated stimulator are electrically isolated. However, they can produce pulses of up to 100 V at up to 20 mA. Injury can still occur from careless use of these devices. Several points must be observed for safe operation of the Isolated Stimulator:

Safety Notes

• The Isolated Stimulator output must only be used with the supplied bar stimulus electrode.

• The Isolated Stimulator output must not be used with individual (physically separate) stimulating electrodes.

• Stimulation must not be applied across the chest or head.

• Do not hold one electrode in each hand.

• Always use a suitable electrode cream or gel and proper skin preparation to ensure a low-impedance electrode contact. Using electrodes without electrode cream can result in burns to the skin or discomfort for the subject.

• Subjects with implantable or external cardiac pacemakers, a cardiac condition, or a history of epileptic episodes must not be subject to electrical stimulation.

• Always commence stimulation at the lowest current setting and slowly increase the current.

• Stop stimulation if the subject experiences pain or discomfort.

• Do not use faulty cables, or those that have exhibited intermittent faults.

• Do not attempt to measure or record the Isolated Stimulator waveform while connected to a subject using a PowerLab input or any other piece of equipment that does not carry the appropriate safety symbol (see Safety Symbols above).

Always check the status indicator on the front panel. It will always ﬂash green each time the stimulator delivers a current pulse. A yellow ﬂash indicates an ‘out-of-compliance’ (OOC) condition that may be due to the electrode contact drying up. Always ensure that there is good electrode contact at all times. Electrodes that are left on a subject for some time need to be checked for dry contacts. An electrode impedance meter can be used for this task.

• Always be alert for any adverse physiological effects in the subject. At the ﬁrst sign of a problem, stimulation must be stopped, either from the software or by ﬂicking down the safety switch on the front panel of any built-in Isolated Stimulator or the ML180 Stimulus Isolator.

• The ML180 Stimulus Isolator is supplied with a special transformer plug pack. The plug pack complies with medical safety requirements. Therefore, under no circumstances should any other transformer be used with the Stimulus Isolator. For a replacement transformer plug pack please contact your nearest ADInstruments representative.

General Safety Instructions

To achieve the optimal degree of subject and operator safety, consideration should be given to the following guidelines when setting up a PowerLab system either as stand-alone equipment or when using PowerLab equipment in conjunction with other equipment. Failure to do so may compromise the inherent safety measures designed into PowerLab equipment. The following guidelines are based on principles outlined in the international safety standard IEC60601-1-1: General requirements for safety - Collateral

standard: Safety requirements for medical systems . Reference to this

standard is required when setting up a system for human connection.

Spirometer Owner’s Guide

PowerLab systems (and many other devices) require the connection of a personal computer for operation. This personal computer should be certiﬁed as complying with IEC60950 and should be located outside a

1.8 m radius from the subject (so that the subject cannot touch it while

connected to the system). Within this 1.8 m radius, only equipment complying with IEC60601-1 should be present. Connecting a system in this way obviates the provision of additional safety measures and the measurement of leakage currents.

Accompanying documents for each piece of equipment in the system should be thoroughly examined prior to connection of the system.

While it is not possible to cover all arrangements of equipment in a system, some general guidelines for safe use of the equipment are presented below:

• Any electrical equipment which is located within the SUBJECT AREA should be approved to IEC60601-1.

• Only connect those parts of equipment that are marked as an APPLIED PART to the subject. APPLIED PARTS may be recognized by the BF or CF symbols which appear in the Safety Symbols section of these Safety Notes.

• Only CF-rated APPLIED PARTS must be used for direct cardiac connection.

• Never connect parts which are marked as an APPLIED PART to those which are not marked as APPLIED PARTS.

• Do not touch the subject to which the PowerLab (or its peripherals) is connected at the same time as making contact with parts of the PowerLab (or its peripherals) that are not intended for contact to the subject.

• Cleaning and sterilization of equipment should be performed in accordance with manufacturer’s instructions. The isolation barrier may be compromised if manufacturer’s cleaning instructions are not followed.

• The ambient environment (such as the temperature and relative humidity) of the system should be kept within the manufacturer’s speciﬁed range or the isolation barrier may be compromised.

• The entry of liquids into equipment may also compromise the isolation barrier. If spillage occurs, the manufacturer of the affected equipment should be contacted before using the equipment.

Safety Notes

• Many electrical systems (particularly those in metal enclosures) depend upon the presence of a protective earth for electrical safety. This is generally provided from the power outlet through a power cord, but may also be supplied as a dedicated safety earth conductor. Power cords should never be modiﬁed so as to remove the earth connection. The integrity of the protective earth connection between each piece of equipment and the protective earth should be veriﬁed regularly by qualiﬁed personnel.

• Avoid using multiple portable socket-outlets (such as power boards) where possible as they provide an inherently less safe environment with respect to electrical hazards. Individual connection of each piece of equipment to ﬁxed mains socketoutlets is the preferred means of connection.

If multiple portable socket outlets are used, they are subject to the following constraints:

• They shall not be placed on the ﬂoor.

• Additional multiple portable socket outlets or extension cords shall not be connected to the system.

• They shall only be used for supplying power to equipment which is intended to form part of the system.

Cleaning and Sterilization

ADInstruments products may be wiped down with a lint free cloth moistened with industrial methylated spirit. Refer to the manufacturer’s guidelines or the Data Card supplied with transducers and accessories for speciﬁc cleaning and sterilizing instructions.

Preventative Inspection and Maintenance

PowerLab systems and ADInstruments front-ends are all maintenance-free and do not require periodic calibration or adjustment to ensure safe operation. Internal diagnostic software performs system checks during power up and will report errors if a signiﬁcant problem is found. There is no need to open the instrument for inspection or maintenance, and doing so within the warranty period will void the warranty.

Spirometer Owner’s Guide

Your PowerLab system can be periodically checked for basic safety by using an appropriate safety testing device. Tests such as earth leakage, earth bond, insulation resistance, subject leakage and auxiliary currents and power cable integrity can all be performed on the PowerLab system without having to remove the covers. Follow the instructions for the testing device if performing such tests.

If the PowerLab system is found not to comply with such testing you should contact your PowerLab representative to arrange for the equipment to be checked and serviced. Do not attempt to service the device yourself.

Environment

Electronic components are susceptible to corrosive substances and atmospheres, and must be kept away from laboratory chemicals.

Storage Conditions

• Temperature in the range 0–40 °C

• Non-condensing humidity in the range 0–95%.

Operating Conditions

• Temperature in the range 5–35 °C

• Non-condensing humidity in the range 0–90%.

Disposal

• Forward to recycling center or return to manufacturer.

Safety Notes

Spirometer Owner’s Guide

Overview

The Spirometer is a modular device, in a family called front-ends,

designed to extend the capabilities of the PowerLab

Spirometer is a precision differential pressure transducer for

measurements of respiration ﬂows.

system. The

Chapter 1 Overview

This chapter provides an overview of the Spirometer Front-end,

describing its features, and discusses aspects of its use.

+ 29 hidden pages

ADINSTRUMENTS Spirometer Owners Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

Safety Notes

Overview