Embla N7000 and S7000 Clinical Manual Rev 7.0 Jan 2008

Embla N7000 and S7000 Clinical Manual Copyright © 2008 Embla. All rights reserved. Issued January 2008 Document #: D-0412-035, Revision 7.0 JLB Document Item #: 2800101 Embla 11001 W. 120th Ave. Suite 200

Kon. Wilhelminaplein 13/2.09.05 1060 CM Amsterdam

Broomfield, CO 80021

P.O. Box 69464

USA Tel: +1.303.962.1800

The Netherlands Tel: +31 20 3460130

Toll-Free: 888.662.7632 Fax: +1.303.962.1810

Fax: +31 20 3460121

Website: www.embla.com

Email: [email protected] [email protected]

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 RemLogic, Somnologica and XactTrace are trademarks of Embla Systems Inc. REMbrandt and Embla are registered trademarks of Embla Systems Inc. All other trademarks are the property of their respective owners. The Embla N7000 and S7000 systems are manufactured by Cogent Technologies in the United Kingdom for Embla Systems Inc. Printed in the Netherlands.

Contents This Manual...1 About the Embla N7000 and S7000...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 Embla N7000 and S7000 System Components ... 7 Embla N7000 System Components ... 7 Embla S7000 System Components ... 8 Unpacking ... 8 Communication Unit... 9 About the Communication Unit ... 9 Rear Panel...10 Communication Unit Cables ...12 Bedside Unit ...12 Impedance Test Button ...14 Channel Inputs ...14 Interfaces...15 Bedside Unit Lights and Symbols ...16 Bedside Unit Sensors...18 Bedside Unit Cable ...18 Mounting Bracket...18 Bedside Unit Shoulder Strap ...19 Sensors...20 Electrodes ...20 Sensor Inputs ...20 Patient Unit ...22 About the Patient Unit...22 Patient Unit Channels ...23 Patient Unit Interfaces...23 Proxy ...24 Patient Unit Sensors...25 Patient Unit Cable...26

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Embla N7000 and S7000 Clinical Manual

Assembling the System... 28 Mounting the Bedside Unit Bracket...28 Mounting the Communication Unit ...29 Attaching the ID Card to the Communication Unit ...30 Connecting the System...31 Connecting the Units...31 Connecting the Communication Unit ...31 Connecting the Bedside Unit...32 Connecting the Patient Unit...33 Installing the System on the Network...35 Connection Types ...36

Performing a Study ... 38 Study Types...38 Attaching the Bedside Unit Sensors...38 Attaching Oximeter and Oximeter Flex Sensor...40 The Oximeter Sensor...41 Attaching the Oximeter Flex Sensor...42 Other Oximeter Sensors ...43 Attaching XactTrace Respiratory Effort Sensors ...44 Fitting the XactTrace Belt...45 Attaching the XactTrace Belts to the Patient...46 Storing the Belt Lock ...47 Considerations for Use...47 Attaching Nasal Pressure Sensor...48 Attaching Snoring Sensor ...49 Attaching the Thermistor...50 Attaching the Patient Unit to the Patient...51 Connecting Sensors to the Patient Unit...53 Connecting Sensors to the Bedside Unit ...54 Testing the Electrode Impedance ...55 Performing an Impedance Test When Not Recording ...55 Performing an Impedance Test During a Recording ...56 Stopping an Impedance Test...56 Activating the Calibration Test Signal...56 During Use...57

System Maintenance ... 58 Cleaning the System Units...58 Cleaning Sensors ...58 Single Use Sensors...59 Environment...59 Factory Calibration...60 ii

Contents Disposal ...60

Troubleshooting... 61 Problems Starting a Recording...61 Unclear Signals ...62

Technical Specifications ... 63 Communication Unit...63 N7000 Bedside Unit ...66 S7000 Bedside Unit...68 Patient Unit ...70 Bracket...71 Nonin XPod Oximeter Accuracy...72 Materials List ...73

Further Readings... 74 List of Tables ... 75 Glossary ... 76 Index... 78

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This Manual This clinical manual is intended for Embla N7000 and S7000 systems users. 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 the following URL: 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 N7000 and S7000 The Embla N7000 and S7000 recording systems are full polysomnography systems and are 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 N7000 and S7000 systems integrate advanced digital technology and precision engineering into a flexible, rugged, full polysomnography system. The systems, featuring an Ethernet network connection, are simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Offering 12 referential channels the Embla S7000 is ideal for sleep centers. Offering 32 referential channels and expanded EEG capability the Embla N7000 meets the most demanding clinical and research needs. Additionally, both systems have 8 bipolar channels plus an extensive set of respiratory signals. They also include auxiliary inputs and digital serial ports for additional devices such as CPAP and CO2 machines. The system units build on the proven convenience and quality of the Embla A10 and Embletta PDS and include XactTrace technology.

Safety and Regulatory Information Before using the Embla N7000 and S7000 systems, 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 N7000 and S7000 systems: •

The Embla N7000 and S7000 systems are NOT CERTIFIED TO BE USED FOR CONTINUOUS MONITORING where failure to operate can cause injuries or death of the patient.

•

The systems 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 N7000 and S7000 systems should be avoided at all times. The systems are neither water resistant, drip-proof nor splash-proof and the cleaning instructions in this manual need to be strictly adhered to.

•

Do not use the Embla N7000 and S7000 systems in an MRI environment.

•

Do not use the Embla N7000 and S7000 devices in an explosive environment, that is, in the presence of flammable liquids or gases.

•

The Embla N7000 and S7000 systems are 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 N7000 and S7000 systems 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 3

Embla N7000 and S7000 Clinical Manual the pacemaker’s accompanying documents regarding its certifications and requirements of use or, if necessary, contact the producer.

4

•

Use only with sensors and electrodes provided by Embla or with sensors that have been validated by Embla. Use of other sensors with the Embla N7000 and S7000 devices 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 devices.

•

The Embla N7000 and S7000 devices comply 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 devices’ performance. For these reasons, special precaution regarding EMC is needed when the devices are installed and put into service.

•

Portable and mobile RF communications can affect the performance of the Embla N7000 and S7000 systems.

•

The Embla N7000 and S7000 systems should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the devices 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 devices. 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 systems, 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 N7000 and S7000 systems are 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 N7000 and S7000 systems does not involve any patient monitoring or diagnosis.

Certifications 0413

The Embla N7000 and S7000 devices are 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 products comply 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 N7000 and S7000 devices is in conformity with Annex II of the Directive 93/42/EEC on medical devices.

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Embla N7000 and S7000 Clinical Manual

Classifications The following classifications are applicable to the Embla N7000 and S7000: The Embla N7000 and S7000 devices are classified as Class IIa medical devices according to the Medical Device Directive (MDD) of the European Union. The Embla N7000 and S7000 are classified as Class II devices.

Electric shock: According to the degree of protection against electric shock the Embla N7000 and S7000 devices are classified as of type BF. Ingress of liquids: The Embla N7000 and S7000 devices are classified as an ordinary equipment regarding ingress of liquids, that is, they are not dripproof, splash-proof or watertight. Degree of Safety: The Embla N7000 and S7000 devices are 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 WEEE shall be collected separately and returned to the appropriate collection system available. Where you see this symbol on the devices, it means that the date of manufacture is indicated adjacent to this symbol.

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System Components Embla N7000 and S7000 System Components The Embla N7000 and S7000 systems are composed of three subunits that are connected together: the Communication Unit, Bedside Unit (also known as the Physiological Unit), and the Patient 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.

Embla N7000 System Components The Embla N7000 system consists of three main components: Communication Unit, Bedside Unit, Patient Unit.

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Embla N7000 and S7000 Clinical Manual

Embla S7000 System Components The Embla S7000 system consists of three main components: Communication Unit, Bedside Unit, Patient Unit.

Unpacking The Embla N7000 and S7000 systems are delivered with product information sheets. Read the product information carefully and verify the presence of each component. Each component is easily identifiable. If an item listed on the product information sheets is not delivered with the system, contact your sales distributor. Before performing patient studies, assemble the system on a table beside a computer and conduct test recordings.

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System Components

Communication Unit About the Communication Unit The Communication Unit supplies the power to the Bedside Unit and communicates between the Embla N7000 or S7000 device 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 has a power indicator light (labeled "power") which is green when the unit is turned on.

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Embla N7000 and S7000 Clinical Manual

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

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 Item

Description

1

Mains power supply

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

2

Voltage selector switch

Determines the voltage used.

(115/230V~)

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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 Technical Support ([email protected]) for information on which external devices can be connected to these ports.

System Components Item

Description

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.

6

AUX 1-8

There are four dual channel auxiliary inputs on the rear panel. These inputs can each read 2 channels (8 in 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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Embla N7000 and S7000 Clinical Manual

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 RS-232 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 reads and transmits the physiological channels used during the study, such as EEG, EOG, EKG/ECG, and EMG.

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System Components 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.

N7000 Bedside Unit input panel

S7000 Bedside Unit input panel

Bedside Unit rear panel

Communication Unit Interface The Communication Unit Interface is on the underside of the Bedside Unit. This interface is connected to the mounting bracket.

Electrocap Interface This interface located on the side of the Bedside Unit is used with Electrocap technology. See Technical Specifications for detailed information on the Electrocap interface.

Patient Unit Interface The bottom end of the Bedside Unit features the Patient Unit interface and is marked with this symbol: . This connection communicates with and supplies power to the Patient Unit.

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Embla N7000 and S7000 Clinical Manual

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.

Channel Inputs The Input Panel of the Bedside Unit features the channel inputs, an event button, an impedance test button and status lights.



The channel inputs on the Input Panel are only meant for 1.5mm touch-proof plugs.

N7000 Channel Inputs The N7000 Bedside Unit reads and transmits a total of 40 channels and includes an input for a ground electrode labeled PGND. •

•

Thirty-two channels are referential and have different labels: •

23 channels are intended for EEG and labeled according to the 10-20 system.

•

2 are labeled LOC and ROC and intended for EOG.

•

7 are labeled X1 through X7 and are extra referential channels.

Eight channels are bipolar channels and are labeled with numbers and "+" and "-" symbols. These channels can be used to measure, for example, EMG and EKG/ECG.

S7000 Channel Inputs The S7000 Bedside Unit reads and transmits a total of 20 channels and includes an input for a ground electrode labeled PGND. •

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Twelve channels are referential and have different labels. •

6 channels are intended for EEG

•

2 are labeled ROC and LOC and intended for EOG

•

4 are labeled X1 through X4 and are extra referential channels.

System Components •

Eight channels are bipolar channels and are labeled with numbers and "+" and "-" symbols. These channels can be used to measure, for example, EMG and EKG/ECG.

Interfaces Communication Unit Interface The Communication Unit Interface is on the underside of the Bedside Unit. This interface is connected to the mounting bracket. Warning: The interface on the underside of the Bedside Unit should not be touched when the system is connected to the patient.

Electrocap Interface This interface located on the side of the Bedside Unit is used with Electrocap technology. See Technical Specifications for more information.



The Electrocap interface is protected with a cover that should always be in place when the connection is not in use.

Connecting the Electrocap If an Electrocap is used instead of standard electrodes, the Electrocap should be connected to the side interface on the Bedside Unit.

Connecting the Electrocap to the N7000 Bedside Unit

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