Embla S4500 Clinical Manual Rev 2.0 Nov 2010

Embla S4500 Clinical Manual Copyright © 2010 Embla. All rights reserved. Issued 2010-11-16. Printed in the USA or The Netherlands. Document #: D-0709-053, Revision 2.0 Document Item #: 2800107 Copyright Notice No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form, or by any means, electronic, mechanical, optical, chemical, manual, or otherwise, without the prior written consent of Embla. Disclaimer This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. Embla does not accept any liability for the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by or concluded from data obtained by the products. The user must accept all responsibility for results obtained by software from Embla. All clinical conclusions and decisions that are made based on the use of this product are the responsibility of the user. Embla does not accept any liability or responsibility for damages arising out of the use of or inability to use this product. Trademarks S4500, RemLogic, Somnologica and XactTrace are trademarks of Embla Systems LLC. REMbrandt and Embla are registered trademarks of Embla Systems LLC. All other trademarks are the property of their respective owners. The Embla S4500 is manufactured by Cogent Technologies in the United Kingdom for Embla Systems LLC. MANUFACTURER

EUROPEAN REPRESENTATIVE

Embla Systems 11001 W. 120th Ave., Suite 200 Broomfield, CO 80021 USA Tel: +1.303.962.1800 Fax: +1.303.962.1810

Embla Systems Naritaweg 12J 1043 BZ Amsterdam The Netherlands Tel: +31 20 3460130 Fax: +31 20 3460121

TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632) www.embla.com [email protected] [email protected]

Contents About This Manual ...1 About the Embla S4500 System...2 Safety and Regulatory Information ... 2

Warnings, Cautions and Contraindications ...3 Warnings and Cautions... 3 Intended Use ... 5 Certifications... 5 Classifications ... 6

System Components ...7 Communication Unit ... 7 About the Communication Unit ... 7 Rear Panel ... 8 Communication Unit Cables ...10 Bedside Unit ...10 Status Lights ...11 Impedance Test Button ...12 Channel Inputs ...12 Cable ...14 Mounting Bracket ...14 Shoulder Strap ...15 Sensors ...15 Electrodes ...15 Sensor Inputs ...16

Assembling the System ... 18 Mounting the Bedside Unit Bracket ...18 Mounting the Communication Unit ...19 Creating and Attaching an ID Card to the Communication Unit ...20 Connecting the Units ...21 Connecting the Communication Unit ...21 Connecting the Bedside Unit...22 Installing the System on the Network ...24 Connection Types ...25

Performing a Study ... 27 Study Types ...27 i

Embla S4500 Clinical Manual Attaching the Electrodes...27 Attaching the Oximeter and Oximeter Flex Sensor ...30 The Oximeter Sensor ...31 Attaching the Oximeter Flex Sensor ...31 Other Oximeter Sensors ...33 Attaching XactTrace Respiratory Effort Sensors ...34 Fitting the XactTrace Belt...34 Attaching the XactTrace Belts to the Patient ...36 Storing the Belt Lock ...37 Considerations for Use ...37 Attaching the Nasal Pressure Sensor ...40 Attaching the Snoring Sensor ...42 Attaching the Thermistor...43 Attaching the Body Position Sensor...44 Connecting Sensors to the Bedside Unit ...45 Testing the Electrode Impedance ...46 Activating the Calibration Test Signal ...48 During Use...48

System Maintenance ... 49 Cleaning the System Units...49 Cleaning Sensors ...49 Single Use Sensors ...50 Environment ...50 Factory Calibration ...51 Disposal ...51

Troubleshooting... 52 Problems Starting a Recording ...52 Unclear Signals ...52

Technical Specifications ... 54 Communication Unit ...54 Bedside Unit ...55 Bedside Unit Bracket... 57 Oximeter Accuracy for Type Nonin Xpod...58 Materials List ...59

Further Readings ... 60 List of Tables ... 62 Glossary ... 63 ii

Contents

Index ... 65

iii

About This Manual This clinical manual is intended for all users of the Embla S4500 system. It is assumed that users have a basic knowledge of the Windows environment, working with a mouse, using toolbars, and arranging windows. Sections typically begin with an overview and description of main features, followed by instructions in simple action steps. Embla's Knowledge Base contains helpful articles, product information, and information on the study of sleep. Access this resource at www.embla.com/support/knowbase. For more information on any Embla product feature, or for technical support, please contact Embla Technical Support ([email protected]).

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About the Embla S4500 System The Embla S4500 system is a full polysomnography (PSG) system used to perform online sleep studies in the sleep lab, hospital or clinical environment, under the supervision of a clinician or sleep technician. The Embla S4500 system integrates advanced digital technology and precision engineering into a flexible, rugged, full polysomnography network. Featuring an Ethernet network connection, the system is simple to assemble, with cables streamlined for comfort and reliability. Building on the proven convenience and quality of the Embla S4000 System, the S4500 system has 13 referential channels, 5 bipolar channels, an extensive set of respiratory data channels as well as auxiliary inputs and digital serial ports for additional devices such as CPAP and CO2 machines. The Embla S4500 system can be used with Rembrandt and RemLogic.

Safety and Regulatory Information Before using the Embla S4500 system, please read this clinical manual carefully, paying particular attention to the caution or warning that appears with each safety symbol. Caution: The CAUTION notice denotes a potential hazard. It calls attention to an operating procedure, practice, or the like, which, if not correctly performed or adhered to, could result in damage to the product or loss of important data. Do not proceed beyond a CAUTION notice until the indicated conditions are fully understood and met. Warning: The WARNING notice denotes a hazard. It calls attention to a procedure, practice, or the like, that, if not correctly performed or adhered to, could result in personal injury. Do not proceed beyond a WARNING notice until the indicated conditions are fully understood and met.

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Warnings, Cautions and Contraindications Warnings and Cautions The following warnings and cautions are applicable to the Embla S4500: •

The Embla S4500 is NOT TO BE USED FOR CONTINUOUS MONITORING where failure to operate can cause injuries or death of the patient.

•

The system must not be used for direct cardiac application.

•

Caution: U.S. Federal law restricts this system to sale by, or on the order of, a physician.

•

No user serviceable parts inside. Serviced by Embla and authorized parties only. Warranty void if opened.

•

The contact of liquids with the internal parts and connectors of the Embla should be avoided at all times. The system is neither water resistant, drip-proof nor splashproof and the cleaning instructions in this manual need to be strictly adhered to.

•

Do not use the Embla S4500 system in an MRI environment.

•

Do not use the Embla S4500 device in an explosive environment, that is, in the presence of flammable liquids or gases.

•

The system is not defibrillator proof.

•

Caution must be taken to ensure that cables do not encircle the patient's neck. Special attention is needed in the case of children.

•

The Embla S4500 system does not increase the safety risk for pacemaker patients as long as the pacemakers comply with the EN50061 standard of electrical safety of medical devices. Nevertheless, it is not advisable to do an impedance test on pacemaker patients since it might cause the pacemaker to switch to the interference mode. Prior to using the system with pacemaker patients, the operator should consult the pacemaker’s accompanying documents regarding its certifications and requirements of use or, if necessary, contact the producer. 3

Embla S4500 Clinical Manual

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•

Use only with sensors and electrodes provided by Embla or with sensors that have been validated by Embla. Use of other sensors with this device may impair the signal quality and device performance. Contact Embla Technical Support ([email protected]) for an updated catalog of sensors and electrodes that may be used with the device.

•

The Embla S4500 complies with the international standard IEC60601-1-2 for electromagnetic compatibility for medical electrical equipment. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radiofrequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of interference due to close proximity or strength of source might disrupt the device’s performance. For these reasons, special precaution regarding EMC is needed when the device is installed and put into service.

•

Portable and mobile RF communications can affect the performance of the Embla S4500 system.

•

The Embla S4500 system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.

•

Electrostatic discharges (ESD) may cause artifacts in the signal from the device. Avoid conditions where electrostatic charge can build up because of low humidity and friction against carpets, clothing and sheets made from artificial fibers

•

The operator must be trained to be able to recognize the difference between a valid bio-signal and signal artifacts caused by subject movements, RF disturbances or misplacement of sensors or electrodes.

•

Before starting data acquisition with the system, always check the device profile and patient information in the Embla PSG software application.

•

Always inspect the equipment, particularly the cables and connectors, for evidence of wear before each study. If evidence of wear is found, remove the worn equipment from use and contact Embla Technical Support ([email protected]) for replacement or servicing.

Warnings, Cautions and Contraindications

Intended Use The Embla S4500 system is intended for use by a physician or trained technician for the acquisition of Electroencephalogram (EEG) and polysomnography (PSG) signals and their transmission to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. The use of the Embla S4500 system does not involve any patient monitoring or diagnosis.

Certifications The following certifications are applicable to the Embla S4500: 0413

The Embla S4500 is certified to carry the CE mark. The CE mark is a declaration that Embla is in compliance with the directive set forth by the European Union for medical devices. The ETL mark is a safety symbol which shows that the product has been independently tested and certified to applicable U.S. and Canadian product safety standards. The C-Tick mark indicates that the product complies with the applicable EMC standard and establishes a traceable link between the product and the supplier responsible for placing it on the Australian market. The Embla Quality Management System complies with EN ISO 9001:2000 and EN ISO 13485:2003. Embla certifies that the development, manufacture, sales, and service of the Embla is in conformity with Annex II of the Directive 93/42/EEC on medical devices.

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Embla S4500 Clinical Manual

Classifications The following classifications are applicable to the Embla S4500: The Embla S4500 is classified as Class II device.

Electric shock: According to the degree of protection against electric shock the Embla is classified as of type BF. Ingress of liquids: The Embla S4500 is classified as an ordinary equipment regarding ingress of liquids, that is, it is not drip-proof, splash-proof or watertight. Degree of Safety: The Embla 4500 is not suitable for use in presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE. Mode of operation: Continuous. Where you see this symbol on any device label, it means "Attention: consult accompanying documentation". According to the regulation in Europe on Waste of Electrical and Electronic Equipment (WEEE) the WEEE may not be disposed of as unsorted municipal waste. The Embla S4500 should be returned to Embla when it is ready to be disposed of. Contact Embla at [email protected] for more information. Where you see this symbol on the device, it means that the date of manufacture is indicated adjacent to this symbol.

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System Components The Embla S4500 system is composed of two subunits that are connected together: the Communication Unit and the Bedside Unit (also known as the Physiological Unit). The enclosure of the Bedside Unit is connected to a bracket that holds the unit in place. The systems are connected to a remote standard commercial personal computer through Ethernet/LAN. The recording data is stored on the personal computer where viewing, reviewing and analysis of the data can be done in the application software used.

Communication Unit About the Communication Unit The Communication Unit supplies the power to the Bedside Unit and communicates between the Embla S4500 and an acquisition computer over a Local Area Network (LAN). It has additional inputs for external devices such as a CPAP, and functions in part as a patient isolation unit, preventing a direct electrical connection between the patient and the external devices connected to the system.

Communication Unit (front view)

Four plastic fasteners are supplied with the system that can be used to secure the Communication Unit to a wall. See Mounting the Communication Unit for more information. The unit front panel features a power indicator light (labeled " unit is turned on.

") which is green when the

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Embla S4500 Clinical Manual

Rear Panel The following figure shows the location of the rear panel components on the Embla S4500 Communication Unit:

B CD

G

H

E F Communication Unit (rear view)

Table 1 lists and describes the Communication Unit rear panel components and symbols. Table 1: Communication Unit Rear Panel Components and Symbols

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Item

Description

1

Mains power supply

Includes an on/off switch and a mains power input.

2

Voltage selector switch (115/230V~)

Determines the voltage used.

3

LAN Port

Communication port to the LAN. The required network connection is twisted-pair (TP) Ethernet.

4

COM A & COM B

Serial ports intended for use with supported devices with digital outputs, such as a CPAP or CO2 devices. Contact Embla at [email protected] for information on which external devices can be connected to these ports.

5

TRIG

Trigger input/output port. Intended for use with photic stimulators or other devices requiring a trigger interface. The Trigger input/output is only supported by the Embla N7000 system.

System Components

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AUX 1-8

There are four dual channel auxiliary inputs on the rear panel. These inputs can each read 2 channels (8 total) and support devices that output analog signals.

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Unit Interface

This connection communicates with and supplies power to the other units in the system. Class II power supply. Double isolation. Type BF applied part. Attention: consult accompanying documents. Where you see this symbol on the device, it means that the date of manufacture is indicated adjacent to this symbol.

Warning: The Communication Unit is delivered with the appropriate default voltage setting. Ensure the voltage selector switch is correctly set before turning the unit on. Warning: The use of auxiliary devices compatibility-tested by Embla is recommended. Contact Embla technical support ([email protected]) for information on which external devices can be connected to the Communication Unit inputs. When installing an auxiliary device ensure the tracing from the auxiliary input represents the same value observed on the display of the auxiliary device. Consult the auxiliary device clinical manual for applicable calibration routines.

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Communication Unit Cables Table 2 lists and describes cables used with the communication unit. Caution: Always inspect the equipment, particularly the cables and connectors, for evidence of wear before each study. If evidence of wear is found, remove the worn equipment from use and contact Embla Technical Support for replacement or servicing. Table 2: Communication Unit Cables Cable

Description

Power Cable

Plugs into the mains power input on the rear panel of the Communication Unit and to a standard wall outlet.

Standard Ethernet Cable

Plugs into the Local Area Network (LAN) port on the rear panel of the Communication Unit and to an Ethernet wall outlet. The cable is gray and 5m (197in) long. It is used to connect the system to an already installed network.

Crossover Ethernet Cable

Plugs into the LAN port on the rear panel of the Communication Unit and directly to an acquisition computer. The cable is black with red connectors on each end and 2.5m (98in) long. The crossover cable is used, for example, when testing the system and it cannot be used to connect to an Ethernet wall outlet.

Serial Communication Unit Cable

Connects COM A or COM B ports on the Communication Unit to an RS232 serial port on a PC (not required for normal operation) or a device with an RS-232 port, e.g., an AutoSet device. This cable may be used for possible troubleshooting purposes.

Bedside Unit The bedside unit features a color-coded input panel displaying the patient layout, a built-in impedance button with indicator lights, a one-step disconnect, and 2-pin sensor inputs to reduce patient hookup time and ensure polarity. The Bedside Unit reads and transmits physiological channels used during a study, such as EEG, EOG, EKG/ECG, and respiratory signals. The interface connecting the unit to the 10

System Components Communication Unit is on the underside of the Bedside Unit and is connected to the Bedside Unit bracket. Warning: The interface on the underside of the Bedside Unit should not be touched when the system is connected to the patient. Caution: When you see this symbol on the bedside unit, consult the accompanying documentation for information about the interface.

S4500 Input Panel

Status Lights There are three status lights at the top of the Input Panel: PWR, OXI, and REC. •

PWR: Indicates the power supply. A green light indicates the unit is receiving power. If no light is visible, the unit is not receiving power.

•

OXI: Indicates the status of the connection to the oximeter. A green light indicates connection to the oximeter. If no light is visible, the unit is not connected to the oximeter.

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Embla S4500 Clinical Manual •

REC: Indicates the status of the recording. A green light indicates the unit is recording. If no light is visible, the unit is not recording.

Impedance Test Button The impedance test button is located in the top right hand corner of the Input Panel. An impedance test can be performed when the bedside unit is recording or idle (not recording). To save the results of the impedance test (as part of a recording), press the impedance test button when a recording is in progress. For more information, see Testing the Electrode Impedance.



Although it is possible to test impedance using the test button on the input panel, it is recommended that you use your Embla PSG software to test impedance. If you require a specific impedance threshold, for example, 5kOhms (to meet AASM guidelines) you must perform impedance testing using your Embla PSG software.

Channel Inputs The Bedside Unit reads and transmits a total of 21 channels and includes an input for a ground electrode (PGND) and a reference electrode. On the Embla S4500, the Reference input label refers is CZ.

Bedside Unit

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System Components

Referential Channels The beside unit has 13 referential channels: •

8 channels (M1, M2, F3, F4, C3, C4, O1, O2) intended for EEG and labeled according to the international 10-20 System of electrode placement.

•

2 channels (E1, E2) intended for EOG.

•

3 channels (EMG1, EMG2, EMG3) intended for chin EMG signal.

Bipolar Channels The bedside unit has 5 bipolar channels (indicated by ± symbol). •

±EKG: intended for EKG/ECG.

•

±R EMG: intended for right limb EMG.

•

±L EMG: intended for left limb EMG.

•

The 2 remaining channels, labeled ±1 and ±2, are extra bipolar channels.



Channel inputs on the Input Panel are intended for 1.5mm touch-proof plugs ONLY.

Sensor Input Channels The beside unit has 6 sensor input channels: 5 respiratory data channels and 1 sensor input channel for position. These channels have a proprietary two pin connector with different labels, each with a unique color. •

Thermistor: intended for nasal flow (Color: gray).

•

Snore: intended for snore (Color: white).

•

Position: intended for body position (Color: purple).

•

Thorax: intended for thoracic respiratory effort with XactTrace (Color: blue).

•

Abdomen: intended for abdominal respiratory effort with XactTrace (Color: yellow).

•

Oximeter: intended for oximetry data (Color: brown).



Sensor inputs on the Input Panel are intended for 2 pin touch-proof type connectors ONLY. 13

Embla S4500 Clinical Manual

Luer Lock The bedside unit has 1 Luer Lock Interface. A nasal pressure sensor connects to the Luer Lock and allows measurement of nasal flow/pressure. A flow generator with pressure tubing can also be connected to the Luer Lock to record mask pressure.

Luer Lock on Bedside Unit.

Cable This bedside unit cable connects the Bedside Unit to the Communication Unit. It connects to the Interface marked with the symbol, located on the rear panel of the Communication Unit. This cable is permanently fastened to the mounting bracket and should not be removed unless it needs to be replaced. When the patient needs to leave the bed, the technician can easily disconnect the Bedside Unit itself by releasing it from the mounting bracket.

Mounting Bracket Rugged and mountable anywhere, the Bedside Unit is designed to be easily connected and disconnected. The mounting bracket included with the system has a quick release feature that can be mounted on a wall or bedside table. A handle is attached to the Bedside Unit to simplify mounting and dismounting from the mounting bracket.

Dismounting the Bedside Unit

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System Components

Shoulder Strap The Bedside Unit is lightweight and can easily be worn by the patient with a strap attachment. This allows the Bedside Unit to be easily carried when the patient needs to leave the bed. Use of this accessory, which can be easily fastened to the unit, is optional.

Patient carrying the Bedside Unit with shoulder strap

Sensors The sensors used with the Embla S4500 system can be ordered online at ShopEmbla (www.shopembla.com) or from a local Embla distributor. There are two types of sensors used with the Embla S4500:

Electrodes The sensors used with the Embla Bedside Unit must have 1.5 mm touch-proof connectors. The majority of the sensors that are connected to the Bedside Unit are electrodes. The most common type of electrodes is cup-electrodes (gold, silver, silver-silverchloride). Cup-electrodes require 15