e - Series EEG and PSG User Guide Issue 4 Oct 2004

AA798-04 Part Number: 0208-0004-03 © Compumedics Telemed Pty Ltd, 2000 © Compumedics Limited, 2001-2004 Issue 1 Issue 1.1 Issue 1.2 Issue 2 Issue 3 Issue 4

October 2000 May 2001 August 2001 March 2003 April 2003 October 2004

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without written permission from Compumedics Limited. Requests and inquiries concerning reproduction and rights should be addressed to: The Documentation Manager Compumedics Limited 30-40 Flockhart Street Abbotsford VIC 3067 AUSTRALIA

Revision History Issue 3 to Issue 4 CHAPTER

DESCRIPTION

Chapter 3 Appendix A Appendix C Addendum 1

• • • •

3.4.11 - Add Xpod warning Figures A-1, A-15, A-16, updated part numbers C.1.3 - Updated altitude figure Figure 1-5 - remove part numbers

Issue 2 to Issue 3 CHAPTER

DESCRIPTION

Before You Begin Appendix A

• Added company addresses. • Updated part numbers.

Issue 1.2 to Issue 2 CHAPTER

DESCRIPTION

Before You Begin Appendix A

• Updated company contact details. • Updated part numbers.

Issue 1.1 to Issue 1.2 CHAPTER Chapter 3

Appendix A Appendix C

DESCRIPTION • Revised Figure 3-8. Removed left-side (right side of image) “Over Clavicle” ECG1 (+ve) electrode placement option • Revised 3.5.1 - Contamination • Revised 3.5.8 - Respiratory Bands • Revised Figures A-3, A5, A-7, A-19 • Revised Part Numbers for Isolation Transformer & Position Sensor • Revised C.3.1, C.3.2, C.3.3

Issue 1 to Issue 1.1 CHAPTER

DESCRIPTION

Addendum 1

New

Table of Contents BEFORE YOU BEGIN

I

Intended Use

i

Limited Warranty - Hardware

ii

Limited Warranty - Electrodes, Sensors and Leads

ii

Safety and Effectiveness Considerations

iii

Transport and Storage Conditions

iii

Indications For Use

iii

Contraindications

iv

Labelling Definitions

iv

Symbols and Notational Conventions

iv

Warnings and Cautions

v

Prescription Device

vi

Placement of Equipment

vi

Interference

vi

Manufacturer’s Recommendations

vi

Cleaning

vii

Wiring

vii

Care

vii

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TABLE OF CONTENTS Product Support

1

INTRODUCING E-SERIES EEG/PSG 1.1

2

3

A

viii

1-1

Primary System Components

1-3

SETTING UP E-SERIES EEG/PSG

2-1

2.1

Computer System Requirements

2-2

2.2

Configuring the Hardware

2-3

2.3

Installing Software

2-5

2.4

Configuring Software

2-7

2.5

Communication

2-10

2.6

Recommended Network Configuration

2-21

USING E-SERIES EEG/PSG

3-1

3.1

Recording Studies

3-2

3.2

Connect Accessories

3-3

3.3

Connect Electrodes & Sensors

3-4

3.4

Example PSG Study Electrode & Sensor Connection 3-5

3.5

Cleaning

3-18

3.6

Terminate Study

3-23

3.7

Review, Analyse and Report

3-24

STANDARD PARTS

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TABLE OF CONTENTS

B

A.1

Primary Components

A-1

A.2

Leads

A-3

A.3

Electrodes & Sensors

A-4

A.4

Software

A-7

SIGNAL QUALITY CHECKLIST – PSG STUDY B.1

C

D

3

B-1

Polysomnography Study

B-1

TECHNICAL DESCRIPTION

C-1

C.1

System Environmental Requirements

C-1

C.2

Patient Interface Box / Amplifier

C-2

C.3

Control Module

C-4

C.4

Control Module Power Supply

C-5

GLOSSARY

D-1

INDEX

1

ADDENDUM 1 – EXTERNAL DC INPUTS MODULE

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Before You Begin Intended Use User Guide The E-Series EEG/PSG User Guide contains procedures and information for you to work with the Compumedics E-Series EEG/PSG System. It is a member of a set of several user guides designed to enhance your knowledge of the Compumedics E-Series EEG/PSG System. Hardware The E-Series EEG/PSG System is intended for use by respiratory and / or neurological physicians in private practices or hospital environments to assist in the diagnosis of various sleep or respiratory related sleep disorders or neurological disorders, respectively.

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BEFORE YOU BEGIN

Limited Warranty - Hardware Compumedics Limited warrants each new device to be free from defects in workmanship and materials under normal use and service for a period of twelve (12) months from the date of shipment. Compumedics’ sole obligation under this warranty will be to repair or replace, at its option, products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, seller makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. This warranty is not assignable. Limited Warranty - Electrodes, Sensors and Leads Compumedics Limited warrants each of the Products as free from material defect for a period of three (3) months from the date of delivery to the Distributor. During such period of three (3) months as aforesaid, Compumedics will replace without charge any component found to be materially defective and shall be responsible for all labor or other charges involved in repairing the Product(s) provided that Compumedics shall not be liable to replace components which are defective due to accident or misuse.

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Safety and Effectiveness Considerations Sleep and Neurological studies should only be carried out under the recommendation of a physician. This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information contained in this User Guide before using the equipment. Do not use in conditions where vibrational stresses are excessive. Do not use in excessively unhygienic locations. Do not operate the equipment at ambient temperatures above +40°C or below +10°C (+104°F, +50°F respectively). Do not use in conditions where device may be exposed to liquids. Transport and Storage Conditions -20°C (4°F) to +50°C (122°F), 30-95% RH non condensing conditions. Indications For Use The E-Series EEG/PSG System is intended for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The E-Series EEG/PSG System is designed for stationary, ambulatory and mobile operation and can be used in either the patient’s home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The E-Series EEG/PSG System unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The E-Series EEG/PSG System is only to be used under the direction and supervision of a physician, EEG technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.

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Contraindications Discontinue use if patient displays distress, discomfort or adverse reaction to electrode and/or sensor attachment. Discontinue use if patient perspires excessively. This may cause signal distortion. Labelling Definitions Where the following symbols appear on equipment, according to IEC60601-1 they have the following definitions: Where you see this symbol on any device label, it means “Attention, consult ACCOMPANYING DOCUMENTS” Where you see this symbol on any device label, it means “Type CF Equipment” Where you see this symbol on any device label, it means “Class II Equipment” Symbols and Notational Conventions Following are the conventions used throughout this manual: Convention

Description This icon indicates helpful hints, suggestions and shortcuts. Notes providing additional or vital information to the topic being discussed.

N

Warning:

A Warning indicates a potentially harmful situation.

I

Caution:

A Caution indicates a condition that may lead to equipment damage, malfunction or inaccurate operation.

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Warnings and Cautions

N

WARNINGS • • •

• •

•

•

This device should not be used in the presence of flammable liquids or gasses. This may present an explosion hazard. ELECTRICAL SHOCK HAZARD when covers are removed. Do not use device with covers are removed. For patient safety, do not operate the E-Series EEG/PSG System during electrical storms, if it is being operated with the Mains Power Supply, or if it is connected to any other mains operated equipment. In addition, information could be lost or equipment could be damaged. Damaged items manufactured by Compumedics must be returned to a Compumedics Authorised Repair Centre. Use only the sensors and electrodes supplied with or specifically intended for use with this equipment. Failure to do so may result in invalid study data. Ensure the equipment’s AC voltage rating is correct for the AC voltage at your installation site before using the equipment. The equipment AC voltage rating is shown on the ID Plate on the back of the Mains Power Supply. Failure to do so may damage the Mains Power Supply should it be connected incorrectly. Damaged items manufactured by Compumedics must be returned to a Compumedics Authorised Repair Centre. Pacemaker Patients - Heart rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon heart rate meters. Keep pacemaker patients under close supervision. Equipment is not serviceable by the User’s service personnel.

I CAUTIONS •

•

Operation may be affected in the presence of strong electromagnetic sources, such as electrosurgery equipment. Operation may be affected in the presence of computed tomograph (CT) equipment.

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Prescription Device federal law restricts this device to sale by or on the order of a physician. I Caution: U.S. Placement of Equipment Do not operate the E-Series EEG/PSG System near flammable or explosive gases or materials. Interference The E-Series EEG/PSG System records physiological electrical signals which can be influenced by external electrical interference. Filtering techniques can be used to minimise the influence of external sources of interference. However, by being alert to signal interference, the potential effects of interference can be minimised. Keep the E-Series EEG/PSG System at least one metre away from all electrical appliances. Examples of these include TV sets, electric blankets, air conditioners, microwave ovens, cordless and cellular telephones and walkie-talkies. Interference to physiological signals could be caused by strong transmitter signals such as TV, radio, airport, police, fire and ambulance stations. If recording will occur within two kilometres of one or more of these sources, then ask Compumedics Product Support to help you to determine if your system will operate properly. Synthetic fabric from draperies or carpets can cause interference due to static electricity. Touching an electrically conductive and earthed object before handling the patient or the E-Series EEG/PSG System can prevent the build-up of static charges. Manufacturer’s Recommendations For all third party equipment used with the E-Series EEG/PSG System, follow all of the manufacturer's recommendations and instructions. Be sure to read, understand and follow the instructions in this User Guide and others that come with the system and its components.

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Cleaning Always disconnect the components from all electrical power sources when cleaning the E-Series EEG/PSG System or any of its accessories. Unless specified within these instructions, follow the manufacturer's recommendations and instructions for reusing, cleaning, disinfecting, or sterilising sensors, sensor cables, and monitoring equipment used with the E-Series EEG/PSG System. Do not autoclave, gas, or pressure sterilise any of the E-Series EEG/PSG System components. If any liquid is spilled on E-Series EEG/PSG System component, discontinue using it until it is determined that the component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance. Wiring Do not connect sensor lead wires into electrical outlets. Lead wire contact with electrical outlets presents a serious shock hazard. Keep children and pets away from the E-Series EEG/PSG System. Children or pets could accidentally disconnect the equipment or cause other incidents. Do not allow the sensor wires or connecting cables to become tangled, coiled, or crossed, or wrapped around the patient's neck, arms or legs. This condition may cause strangulation. Handle sensor wires carefully to prevent them breaking inside the insulation. Always grasp and pull the wires at the strain relief area to remove them from the Recorder Unit. Care Do not drop the components of the E-Series EEG/PSG System. If a component is dropped, discontinue using it until it is determined that the component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance.

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Product Support If you have a question regarding the correct use of the E-Series EEG/PSG System and/or any of its components, first refer to the relevant sections in this User Guide for the solution. If you are unable to find the answer in this User Guide, contact Compumedics Product Support on Australia International USA

1800 244 773 +61 3 8420 7396 1-763-294-1346

or your authorised representative. If you call, you should be close to the product so that questions by trained Compumedics technicians can be answered efficiently. You should also have this manual at hand. When you call, please provide the following information: • •

A description of what happened and what you were doing when the problem occurred A description of any attempts made to fix the problem

Repairs of Compumedics Limited’s equipment under warranty or service contract must be made at authorised repair centres. If the equipment needs repair, contact Compumedics Limited’s service department to request an RA Number. When calling, have the device’s model and serial number ready. Service items received without an RA number may be returned to sender or remain un-repaired until such time as a number is raised.

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If you need to ship the equipment, pack the equipment and its accessories carefully to prevent shipping damage. All relevant accessories should accompany the equipment. Compumedics Limited 30-40 Flockhart Street Abbotsford VIC 3067 AUSTRALIA

Phone: +61 3 8420 7300 Fax: +61 3 8420 7399

Compumedics USA 7850 Paseo Del Norte El Paso TX 79912 USA

Phone: +1 915 845 5600 Fax: +1 915 845 2965

Compumedics European Authorised Representative Compumedics Germany GmbH Josef-Schüttler-Str. 2 D-78224 Singen Germany

Phone: +49 7731-79 769-0 Fax: +49 7731-79 769-99

Compumedics E-mail Address Compumedics can also be contacted by sending E-mail via the Internet. This will be most beneficial to international users. The Compumedics E-mail addresses are: Australia USA

[email protected] [email protected]

Compumedics Home Page Visit Compumedics Home Page on the World Wide Web at: •

http://www.compumedics.com

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Chapter

1 Introducing E-Series EEG/PSG The E-Series EEG/PSG System is a device used to collect and store a patient’s EEG and polysomnographic signals, which are then used as an aid in the diagnosis of neurological and/or respiratory and respiratory related sleep disorders by qualified neurologists or physicians. The system is comprised of a number of hardware and software modules, which have been designed to provide up to 44 separate user-definable patient data inputs1 to record and replay patient data. The data is acquired from an array of electrodes, sensors, and transducers. Signal types include, but are not limited to, EEG, EMG, EOG, ECG, airflow, respiratory effort, limb movement, temperature, oxygen saturation, end-tidal CO2, heart rate, respiratory rate, sound and body position. The electrodes and sensors used to acquire patient data are connected between the patient and a Patient Interface Box, which is in turn connected to a Control Module. Several software programs exist to facilitate the recording and subsequent analysis of studies: •

NetBeacon operates as a simple router for the LAN communication system between the Control Module and the Host PC. Once connection is established with a host computer, other computers in the network may monitor the E-Series EEG/PSG device during data acquisition.

1

32 Monopolar Channels, 8 Bipolar Channels for non-electrode sensors and 4 DC Coupled channels, plus expansion options E-Series EEG/PSG System User Guide © Compumedics Limited 2004

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1-2

INTRODUCING E-SERIES EEG/PSG •

PSG Online – This is a data acquisition application for sleep studies. It is used to display graphical or numerical representations of the acquired signals, control the display of data, and facilitate the input of manual data such as technician comments.

•

ProFusion PSG - This program allows the user to view, print, summarise, analyse and create reports from Polysomnograhic Studies recorded with Compumedics Sleep Monitoring Systems2.

•

ProFusion EEG - This program allows the user to view, print, summarise, analyse and create reports from EEG Studies recorded with Compumedics Neurological Monitoring Systems3.

2

E-Series EEG/PSG Systems, Siesta System, S-Series Laboratory-based Sleep Monitoring System, P-Series Portable Sleep Monitoring System 3 E-Series EEG Systems, E-Series EEG/PSG Systems, Siesta System E-Series EEG/PSG System User Guide © Compumedics Limited 2004

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INTRODUCING E-SERIES EEG/PSG 1.1

1-3

Primary System Components The E-Series EEG/PSG System is made up of several components. The primary components are discussed here, while a complete listing can be found in Appendix A.

1.1.1

Host PC The Host PC is a computer or laptop that is configured to communicate with specific E-Series Systems. The computer is installed with PSG Online software, which allows the user to view and record studies, and NetBeacon software, which allows other computers to access the E-Series System via network connection and view and record the studies. This means that a computer anywhere on the network can be recording the study, and any other computer on the network can be observing the study as it is being recorded on the first.

Figure 1-1: Host PC

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