Embla S4000 Clinical Manual ver 2 Jan 2007

Clinical Manual

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Clinical Manual

Embla® S4000

Embla S4000 Clinical Manual Applies to Embla S4000 Copyright © 2006 Embla. All rights reserved. Issued January 2007 Document #: D-0504-026, version 2 Product #: 2800104 Embla 11001 W. 120th Ave., Suite 200 Broomfield, CO 80021 USA Tel: 303.962.1800 Toll-Free: 888.662.7632 Fax: 303.962.1810

European Representative Kon. Wilhelminaplein 13/2.09.05 P.O. Box 69464 1060 CM Amsterdam The Netherlands Tel: +31 20 3460130 Fax: +31 20 3460121

www.embla.com [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 Embla is a registered trademark of Embla Systems Inc. XactTrace is a trademark of Embla Systems Inc. Printed in The Netherlands.

Contents Introduction

Medical Information

System Maintenance

Cleaning the System Units... 40 Cleaning the Sensors... 40 Single Use Sensors ... 41 Environment ... 41 Factory Calibration ... 41 Disposal ... 41

Troubleshooting

Problems Starting a Recording ... 42 Unclear Signals... 42

Technical Specifications

Communication Unit... 43 Bedside Unit ... 44 Bedside Unit Bracket ... 45 Oximeter Accuracy for Type Nonin XPOD ... 46 Materials List ... 46 EMC Information... 47 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 47 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ... 48 Recommended Separation Distance between Portable and Mobile RF Communications Equipment and Embla ... 50

Further Readings

Glossary

Contents ● i

Introduction

The Embla S4000 recording system is a full polysomnography system and is 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 integrates advanced digital technology and precision engineering into a flexible, rugged, full polysomnography system. The system, featuring an Ethernet network connection, is simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Offering 8 referential channels the Embla S4000 is ideal for sleep centers. Additionally, there are 6 bipolar channels plus an extensive set of respiratory signals. The system also includes 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 N7000 and Embla S7000 systems and include XactTrace technology.

This Manual This manual describes the Embla S4000 system. Embla manuals are continually updated to reflect all changes and the most recent version is always located in the Support section on our Web site www.embla.com. Our Knowledge Base features helpful articles that answer specific questions and offer more insight into our products and the study of sleep. You can browse through our articles or search for specific keywords and phrases. Access this useful resource at www.embla.com/support/knowbase/. If you need information regarding any feature or action concerning our products, or if you have a technical question, please contact [email protected]. All user feedback is much appreciated. Please read this manual carefully before use, especially sections marked with an exclamation mark.

Introduction ● 1

System Components

Communication Unit

The Communication Unit communicates between the Embla and an acquisition computer over a Local Area Network (LAN). It supplies the power to the Bedside Unit and features additional inputs for external devices (such as a CPAP). The Communication Unit functions in part as a patient isolation unit that prevents a direct electrical connection between the patient and the external devices connected to the system. 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’s front panel features a power indicator light labeled light is green when the unit is turned on.

. The

Communication Unit Rear Panel

System Components ● 5

Embla S4000 Clinical Manual

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

Voltage selector switch used.

: Determines which voltage is

The Communication Unit is delivered with the appropriate default voltage setting. It is recommended that you confirm that the voltage selector switch is set correctly before turning the unit on.

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

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.

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.

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.

It is recommended to use only auxiliary devices which have been tested for compatibility by Embla. Contact Embla at [email protected] for information on which external devices can be connected to these inputs. When installing an auxiliary device it is very important to validate that the tracing from the auxiliary input is representing the same value as observed on the display of the auxiliary device. Consult the auxiliary device clinical manual for any calibration routines available in the auxiliary device.

: Class II power supply. Double isolation.

: Type BF applied part.

6 ● System Components

: Attention: consult accompanying documents. Unit Interface: This connection communicates with and supplies power to the other units in the system.

Embla S4000 Clinical Manual

Communication Unit Cables Power Cable This cable plugs into the mains power input on the rear panel of the Communication Unit and to a standard wall outlet.

Standard Ethernet Cable This cable plugs into the 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 This 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 This 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, for example, an AutoSet device. This cable may be used for possible troubleshooting purposes.

Bedside Unit

System Components ● 7

Embla S4000 Clinical Manual

The Bedside Unit reads and transmits the physiological channels used during the study, such as EEG, EOG, EKG/ECG, and respiratory signals. The interface that connects the unit to the Communication Unit is on the underside of the Bedside Unit. This interface is connected to the Bedside Unit bracket. The interface on the underside of the Bedside Unit should not be touched when the system is connected to the patient. The symbol means that you should consult the accompanying documents for information about the interface.

Status Lights There are three status lights at the top of the Input Panel: PWR: indicates the power supply. Yellow light means that the unit is receiving power. No light means that there is no power to the unit. OXI: indicates the status of the connection to the oximeter. A yellow light indicates that the oximeter is connected but no light means there is no connection. REC: indicates the status of the recording. A yellow light means the unit is recording whereas no light means that no recording is taking place.

Impedance Test Button An impedance test button is featured in the top right hand corner of the Input Panel . It is possible to do an impedance test both during and when not recording. It can be helpful to do an impedance test prior to the recording by pressing the impedance test button on the Input Panel, but the result will not be stored with the recording. If the impedance test is done during the recording, the test results are stored as part of the recording. See Testing the Electrode Impedance for further information.

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Embla S4000 Clinical Manual

Bedside Unit Channel Inputs The Bedside Unit reads and transmits a total of 21 channels and includes an input for a ground electrode labeled PGND and a reference electrode labeled REF.

Referential Channels Eight channels are referential and have different labels: 6 channels are intended for EEG and labeled according to the 10-20 system. 2 are labeled LOC and ROC and are intended for EOG.

Bipolar Channels 6 channels are bipolar channels and have different labels with "+" and "-" symbols: 1 is labeled ±EMG and is intended for chin EMG signal. 1 is labeled ±EKG and is intended for EKG/ECG. 1 is labeled ±R EMG and is intended for right limb EMG. 1 is labeled ±L EMG and is intended for left limb EMG. 2 are labeled ±1 and ±2 and are extra bipolar channels.

Sensor Input Channels Five sensor input channels are respiratory data channels and one sensor input channel is for position. These channels have a proprietary two pin connector with different labels, each with a unique color code. 1 is labeled Thermistor and is intended for nasal flow (gray). 1 is labeled Snore and is intended for snore (white). 1 is labeled Position and is intended for body position (purple). 1 is labeled Thorax and is intended for thoracic respiratory effort with XactTrace (blue). Copyright © 2006 Embla

System Components ● 9

Embla S4000 Clinical Manual

1 is labeled Abdomen and is intended for abdominal respiratory effort with XactTrace (yellow). 1 is labeled Oximeter and is intended for oximetry data (brown).

Luer Lock One 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 The channel inputs on the Input Panel are only meant for 1.5mm touchproof plugs. The sensor inputs on the Input Panel are only meant for 2 pin touchproof type connectors.

Bedside Unit Cable This cable connects the Bedside Unit to the Communication Unit. It on the rear panel of the connects to the Interface marked with 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.

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

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Embla S4000 Clinical Manual

Dismounting the Bedside Unit using the handle

Bedside Unit Shoulder Strap An adjustable shoulder strap is included in the system that allows the Bedside Unit to be easily carried when the patient needs to leave the bed. This is optional and can easily be removed and fastened again.

Carrying the Bedside Unit

System Components ● 11

Embla S4000 Clinical Manual

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

Electrodes The sensors used with the Embla Bedside Unit must have 1.5mm touchproof connectors. The majority of the sensors that are connected to the Bedside Unit are electrodes. The most common type of electrodes is cupelectrodes (gold, silver, silver-silver chloride). Cup-electrodes require conductance paste and that the electrode site be properly prepared and cleaned for lower impedance values. Cup-electrodes are typically used in recording EEG, EOG, and submental EMG. Single use electrodes are also frequently used. They are typically used in measuring EKG/ECG, and EMG from the anterior tibialis muscles. Single use electrodes are usually Ag-AgCl (silver-silver chloride) electrodes that can be fastened to the skin surface. As with cup-electrode, the electrode site should be properly cleaned and prepared to achieve low impedance.

Sensor Inputs The sensor inputs incorporate sensors for recording respiratory signals and body position signals. Only sensors provided by Embla should be used. The Bedside Unit records signals from six external sensors and one built-in sensor. The external sensors that can be used are abdominal and thoracic respiratory effort, oral/nasal airflow (thermistor), snoring, oximetry and position. The built-in sensor is an airflow pressure transducer. The arrangement of these sensors and optional sensors will be determined by the type of study being performed. See the section Performing a Study for a more detailed description of each sensor and their placement on the patient.

Internal Sensor Pressure Sensor The Bedside Unit has a built-in pressure sensor. The pressure is measured via a nasal cannula connected to the Luer Lock on the bottom of the unit. The pressure sensor can be used for measuring both nasal flow and mask pressure.

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Embla S4000 Clinical Manual

External Sensors Respiratory Effort Sensors The Bedside Unit accommodates two respiratory effort sensors: one around the thoracic region and the other around the abdominal region. The XactTrace – RIP respiratory effort sensors are used with the Bedside Unit. Oximeter The oximeter is external and measures continuously the degree of oxygen saturation of the circulating blood. Snoring Sensor An external piezo-electric snoring sensor can optionally be used with the system. When the snoring sensor is attached to a patient's throat, it generates a signal in response to vibration during snoring. Snoring can also be detected in the pressure signal from the nasal cannula. Body Position Sensor Data regarding the patient’s changes in sleep position may be collected with a body position sensor. Thermistor Airflow may be measured with a thermistor. When the thermistor is used alongside a nasal cannula it can help distinguish between apneas and mouth breathing. The thermistor may also be used in absence of a nasal cannula for apnea detection. The use of oral/nasal cannula is NOT recommended.

System Components ● 13

Medical Information

Intended Use The Embla S4000 system is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals 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 system does not involve any patient monitoring or diagnosis.

Warnings and Cautions

2 ● Medical Information

The Embla is NOT CERTIFIED TO BE USED FOR CONTINUOUS MONITORING where failure to operate can cause injuries or death of the patient. The term CONTINUOUS MONITORING is specified in the standard EN60601-1. The system may NOT be used for direct cardiac application. Caution: 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 splash-proof and the cleaning instructions in this manual need to be strictly adhered to. Do not use the system in an MRI environment. Do not use the 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 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. 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 Copyright © 2006 Embla

Embla S4000 Clinical Manual

impair the signal quality and device performance. Contact Embla at [email protected] for an updated catalog of sensors and electrodes that may be used with the device. The Embla 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. Please refer to the EMC Information section under Technical Specifications provided in this manual Portable and mobile RF communications can affect the performance of the Embla. The Embla 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.

Certifications The Embla is certified to carry the CE mark. The CE mark is a declaration that the Embla is in compliance with the directive set forth by the European Union for medical devices. The S mark is a safety symbol which shows that Intertek has independently tested and certified the product’s compliance to applicable European safety requirements. The ETL mark is a safety symbol and 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 SS-EN ISO 9001:2000 and SSEN ISO 13485:2003. The Embla is manufactured by Embla. 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. For more detailed information on compliance to standards for the Embla S4000 system please contact [email protected] The Embla conforms to the following standards: Copyright © 2006 Embla

Medical Information ● 3

Embla S4000 Clinical Manual

IEC 60601-1, 2nd ed., 1988 with A1,1991 and A2, 1995 : MEDICAL ELECTRICAL EQUIPMENT –PART 1: GENERAL REQUIREMENTS FOR SAFETY IEC 60601-1-2:2001 2nd ed.: MEDICAL ELECTRICAL EQUIPMENT –PART 1: GENERAL REQUIREMENTS FOR SAFETY - 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY –REQUIREMENTS AND TESTS IEC 60601-2-25:1993 with A1, 1999: MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHS. IEC 60601-2-26:1994: MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROENCEPHALOGRAPHS. IEC 60601-2-40:1998: MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT. IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY - 4. COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS. EN 865:1997 PULSE OXIMETERS – PARTICULAR REQUIREMENTS. ISO14971:2000 Medical Devices – Application of Risk Management to Medical Devices.

Classifications

4 ● Medical Information

Embla is a 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 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 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".

Assembling the System

Mounting the Bedside Unit Bracket The Bedside Unit sits in a bracket that should be mounted before any studies are performed. The bracket can, for example, be mounted on a wall or a bedside table next to the patient’s bed. The cable from the Communication Unit is already locked into the mounting bracket and requires no setup. To mount the bracket: 1. Unscrew the bracket from the metal plate. 2. Fasten screws into the four key-shaped holes on the metal plate. 3. Slide the metal plate down so that the screws are held securely in the narrow end of the key-shaped holes. 4. Tighten the screws. 5. Place the bracket on the metal plate and secure it to the plate with the large screw.

The Bedside Unit can now be easily docked and undocked from the bracket.

14 ● Assembling the System

Embla S4000 Clinical Manual

Mounting the Communication Unit Avoid installing the Communication Unit where there is danger of spilling or exposure to any kind of liquid. The Communication Unit should be placed in a well-ventilated area to prevent overheating. It is possible to secure the Communication Unit by mounting it, for example, on a wall. 1. Unscrew the gray rubber feet from the underside of the Communication Unit. 2. Replace the feet with the fasteners: slide the ridge of the fastener into the groove on the unit's underside so that the holes of the fasteners are aligned with the corresponding holes on the Communication Unit. 3. Attach the fasteners with two screws each. 4. Screw the Communication Unit to the wall.

Assembling the System ● 15

Embla S4000 Clinical Manual

Attaching the ID Card to the Communication Unit It is possible to record from more than one Embla on the same acquisition computer. Each device is identified in the acquisition application by its serial number and given a custom name. It is very important that the identity of the device is clear, and that there is accordance between the physical devices and the devices as they are identified in the application. With the use of the ID card, the serial number and the custom name of each Communication Unit is easily accessible. After the Communication Unit has been put into place, for example mounted on the wall, the ID card should be attached to the unit's surface where it is well visible. 1. On the paper card, write the custom name. 2. Place the card inside the plastic sleeve.

3. Peel the safety paper form the back of the sleeve. 4. Firmly apply the sleeve to the desired place on the Communication Unit.

A possible location for the ID card. This would be a typical placement when the front panel of the Communication Unit is clearly visible. The ID card should NOT be placed on top of the ventilation opening.

16 ● Assembling the System

Embla S4000 Clinical Manual

Connecting the Units Connecting the Communication Unit The Communication Unit should be placed in a well-ventilated area to prevent overheating. Avoid installing the Communication Unit where there is danger of spilling or exposure to any kind of liquid.

1. Confirm that the voltage selector switch is set correctly. 2. Confirm that the Communication Unit is turned off. 3. Connect the gray Ethernet cable to the port labeled LAN on the Communication Unit. 4. Connect the cable to the Ethernet outlet on the wall. It is recommended that the net being used for the sleep study be isolated from other net users. 5. Connect any external devices that will be used with the system. Devices that have a digital output should be connected to the COM connections. Devices that have analog output signals should be connected to the connectors labeled AUX. Check the input/output ranges before connecting external devices. Please contact [email protected] for information on which devices are recommended and supported by Embla. See Technical Specifications for more detailed information on the AUX and COM inputs. 6. Connect the Bedside Unit cable to the interface labeled

Assembling the System ● 17

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Embla S4000 Clinical Manual ver 2 Jan 2007