Embla titanium Clinical Manual Rev 4.0 July 2010

Embla titanium Clinical Manual Applies to the Embla titanium Copyright © 2010 Embla. All rights reserved. Issued July, 2010. Printed in the USA or The Netherlands. Document #: D-0705-045, Revision 4.0 Item #: 2800301

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 Somnologica, XactTrace and titanium are trademarks of Embla Systems LLC. Embla is a registered trademark of Embla Systems LLC. Manufactured in Italy by: Micromed S.p.A. via Giotto 2 – 31021 Mogliano Veneto (TV), Italy

Distributed by Embla. For assistance, please contact Embla Technical Support ([email protected]). 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 Warnings, Cautions and Contraindications ... iv Introduction ... 2 Embla titanium Components ... 3 Embla titanium Recorder ... 3 Front Panel ... 3 Back Panel ... 5 Integrated Headbox and Inputs ... 6 Connectors and Isolation Interfaces ... 9 titanium USB Interface ... 9 titanium Network Interface ...10 titanium Interface Cable ...10 Quick Disconnect Cable ...10 Compact Flash Memory Card ...11 Batteries ...11 AA Batteries ...11 Carrying Case ...13

Assembling the System ...14 Inserting the Batteries in the Embla titanium ...14 Checking the Battery ...14 Inserting the Flash Memory Card ...15 Recommended Flash Memory Card ...15 Formatting the Memory Card ...15 Memory Card Protection Cover ...16 Recording Duration - Ambulatory Studies ...17 Connecting the Embla titanium System ...18 Online Study - Isolated Network ...18 Online or Ambulatory Study - Cable ...19 Disconnecting the Embla titanium ...20

Working with titanium Menus ...21 Menu Overview ...21 Menu Functions ...21 Battery Level ...22 Date/Time ...22 Available Functions ...22

About Preparing a Study ...28 i

Embla titanium Clinical Manual Ambulatory - Holter Mode with PC Setup ... 28 Online - Headbox Mode on Network ...28 Online - Headbox Mode with Cable ...29

Attaching the Sensors ...30 Attaching the Sensors...30 Attaching... ...30 Attaching the Electrodes...30 EKG Sensors ...33 LM Sensors ...34 Attaching XactTrace Respiratory Effort Sensors ...35 XactTrace Single Use Belts ...35 XactTrace Reusable Belts ...38 Storing the Reusable Belt ...40 Attaching Oximeter and Oximeter Flex Sensor ...40 Attaching the Oximeter Flex Sensor ...41 Other Oximeter Sensors ...42 Attaching Nasal Pressure Sensor ...43 Attaching the Snoring Sensor ...44 Thermistor ...45 Connecting Sensors to the Embla titanium ...47

Calibration and Impedance Checks ...48 Ambulatory Recordings ...49 Preparing the Recorder ...49 Entering Patient Information ...50 Programming the Embla titanium ...51 Starting and Stopping Ambulatory Recordings ...54 Manual Start ...54 Manual Stop ...55

Online Recordings ...56 Preparing the Recorder ...56 Entering Patient Information ...57 Starting Online Recordings ...58 Stopping and Resuming Online Recordings ... 60 Stopping ...60 Resuming ...60

Ending the Study ...62 Downloading the Study ...62 ii

Contents Removing the Sensors from the Patient ...63

System Maintenance ...64 Cleaning the System Units...64 Cleaning Sensors ...64 Single Use Sensors ...65 Environment ...65 Factory Calibration ...65 Disposal ...65

Troubleshooting ...66 Troubleshooting the Embla titanium ...66 Problems Starting a Recording ...66 Unclear Signals ...66 Troubleshooting the Flash Memory Card ...67 Warning Messages during Acquisition ...67

Technical Specifications ...69 Embla titanium Specifications ...69 BQ USB and BQ NET - Specifications ...71 BQ USB Isolation Interface ...71 BQ NET Interface...71 Certifications...72 Classifications ...73

Index ...74

iii

Warnings, Cautions and Contraindications

iv

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

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The system may NOT be used for direct cardiac application.

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

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The Embla titanium and its components are not intended for use in an oxygen tent or any other enclosed oxygen-enriched environment.

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

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The Embla titanium 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.

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The Embla titanium optional DC Isolation Box must be connected to the OXY channel when connecting any external medical device that is not self-powered/battery powered. Contact your Embla representative for more information about the DC Isolation box.

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

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The system is not defibrillator proof.

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The contact of liquids with the internal parts and connectors of the Embla titanium 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.

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Do not use the system in an MRI environment.

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

Contents •

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 at [email protected] for an updated catalog of sensors and electrodes that may be used with the device.

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The Embla titanium 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 radio-frequency 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.

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

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The Embla titanium 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.

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Electrostatic discharges (ESD) may cause artifacts in the signals 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.

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

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If the Embla titanium is dropped or falls, be sure to check that the device is working properly by running an impedance check and sensor calibration before using the titanium on a patient. If these checks are inconclusive or fail, contact Embla Technical Support at [email protected].

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

v

Introduction The Embla titanium recording system is a portable polysomnography (PSG) system used to perform ambulatory and online sleep studies in the sleep lab, hospital, home or clinical environment. The Embla titanium integrates precision engineering into a rugged, hand-held PSG system. It features an integrated LCD display and built-in keypad. The system offers a USB or network connection for easy patient setup using a PC. For online recordings, the Embla titanium is powered by the BQ NET Interface or the BQ USB interface via the titanium Interface cable. During ambulatory recordings, the Embla titanium is powered by 2 type AA alkaline batteries. In ambulatory studies, the data is stored directly on the Embla titanium flash memory card and transferred to the PC for analysis and review using Embla software. In online studies, the titanium is configured so that data is buffered to the memory card, and transferred continuously to the PC. The Embla titanium is ideal for all sleep protocols and can meet the most demanding clinical and research needs. The Embla titanium records 34 channels: 12 referential channels with fixed common reference, and 12 bipolar channels that can be changed to referential. The Embla titanium also supports an extensive set of respiratory signals, including Embla’s XactTrace™ technology for highly sensitive and reliable respiratory effort signals, integrated body position, 2 internal pressure sensors and integrated oximetry for collecting SpO2, heart rate and plethysmogram data. Two DC inputs offer support for additional external devices such as CPAP and CO2 machines.

2

Embla titanium Components Embla titanium Recorder Front Panel The front panel features a status indicator light, a keypad for system control and an integrated LCD screen for displaying system status information. The bottom of the Embla titanium provides access to the removable Compact Flash memory card used for data storage and the 4-pin port for the titanium Interface cable that connects the recorder to the BQ USB interface or the network (BQ NET) interface.

Embla titanium - Front view

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Embla titanium Clinical Manual

Keys and Labels on Embla titanium Keys

Function Left

CL

Center Left

CR

Center Right

OK RI-OK

Right

is used to turn on the Embla titanium. and

(CL) are used to select different functions scrolling the cursor vertically.

OK (RI-OK) is used to start the selected function. OK (RI-OK) and CR are used to change the values in the range of the selected function. The abbreviation in brackets after a command (written in UNDERLINED CAPITAL LETTERS) indicates the key to enable it (e.g. ESC [RI-OK]). The basic key combinations: •

Left two keys: scroll through menu and select items

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Right two keys: change the values in a menu item

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OK key: start functions When several menu choices are displayed across the bottom of the LCD display, the key directly beneath the option is used to select the desired option.

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Embla titanium Components

Back Panel The back of the Embla titanium recorder displays the channel input label and provides access to the battery compartment.

Embla titanium -rear top view

Channel Label The Channel Label is used to identify the sensor inputs on the headbox on the top of the Embla titanium. Please refer to the Headbox section for detailed information.

Back Panel Symbols For an explanation of the symbols that appear on the back panel, please see the Classifications section under Technical Specifications.

Battery Compartment The battery compartment is located on the back panel. This compartment is opened by pressing and sliding the compartment cover downward. 5

Embla titanium Clinical Manual

Integrated Headbox and Inputs The top of the Embla titanium recorder is the sensor input area where electrodes and sensors are connected to the device.

Embla titanium - front top view

The Embla titanium Headbox accommodates the following channels: titanium Headbox Channels Channel

Description

1 to 12

Monopolar channels

13 to 24

Monopolar, Bipolar or Sensor channels

25, 26

DC channels (white, three-pin connector)

27, 28

XactTrace belts (Blue - Thorax, Yellow - Abdomen)

29, 30

Air Pressure

6

Embla titanium Components Channel

Description

31

Plethysmogram

32

Body position

33

SPO2

34

Pulse

Referential Inputs Channels 1-12 are monopolar and are identified numerically via the channel label on the back panel. These inputs are orange, 1.5 mm touch proof connectors and are used for EEG and EOG sensors. These channels are connected to the positive input of the amplifier. The negative inputs for these channels are connected to the REF input. These channels use the REF input as a fixed common reference.

Multi-Use Inputs Channels 13-24 are multi-use inputs and are identified numerically via the channel label on the back panel. Each input pair is comprised of a red input (+) and a black input (-) using 1.5 mm touch proof connectors. These channels can be used to measure bipolar signals, for example, EMG and EKG/ECG, Monopolar signals (the red input connected to the REF input), and Sensors, such as those used for measuring snoring and airflow. •

The multi-use channels can be configured as monopolar inputs for a total of up to 24 referential inputs.

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If a multi-use channel is configured to be a monopolar channel, its negative input is then internally connected to the REF plug.

Patient Ground The patient ground is identified as PGND (G1) on the channel label on the back panel. This input is a green, 1.5 mm touch proof connector.

Fixed Common Reference The Common reference is identified as REF (G2) on the channel label on the back panel. This input is a black, 1.5 mm touch proof connector. REF is the fixed common reference for channels 1-12 and is used for channels 13-24 only when some or all of those multi-use inputs are set as monopolar inputs.

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Embla titanium Clinical Manual

DC Inputs The two DC channels are identified as DC1-2 on the channel label on the back panel. This input is a white, 3-pin, 1mm touch proof connector. •

The DC Input channels (DC1-2) are only used to directly interface passive, battery powered DC patient-applied sensors (such as a body position sensor). These sensors must not be connected to other devices. The DC input channels can be configured for battery-powered DC sensors in Embla software. An interface cable may be needed to interface your battery-powered DC sensor with one of the DC channels using this connector. Please check with your Embla representative.

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If the ancillary DC device is not battery-powered (self-powered), such as a CPAP device or Oximeter, then the optional Embla titanium DC isolation box must be used. The DC isolation box must be connected to the OXY channel before the DC device is connected. The Oximeter cable can also be connected to the DC isolation box. Contact your Embla representative for more information about purchasing the DC Isolation box.

The Embla titanium DC Isolation Box must be connected to the OXY channel when connecting any external medical device that is not self-powered/battery powered. Contact your Embla representative for more information about the DC Isolation box. Caution: Auxiliary DC devices must meet the following requirements to be connected to the DC inputs of the DC isolation box: Auxiliary Device Requirements Description

Properties

Maximum Output Voltage Range

-5.0V to +5.0V with a common ground

Dynamic Range

96 dB

Maximum Bandwidth

80Hz

Maximum Output Impedance

1 kOhm

XactTrace Inputs Two respiratory effort channels using the Embla XactTrace respiratory effort sensors are available. These channels are identified as THOR (thorax) and ABDO (abdomen) on the channel label on the back panel. The THOR input is a blue, 2 pin, 1 mm touch-proof connector. The ABDO input is a yellow, 2 pin, 1 mm touch proof connector. These input colors correspond 8

Embla titanium Components to the XactTrace sensor's plug colors to ensure correct interfacing of the thorax and abdominal sensors.

Pressure Inputs Two built-in pressure channels are available and are identified as Pdiff and Pnasal on the channel label on the back panel. •

Pdiff has a dual-connector used for measuring differential pressure inputs.

•

Pnasal has a Luer connector and is used to measure the pressure via a nasal cannula. The Pnasal channel is used for measuring nasal flow. A flow generator with pressure tubing can also be connected to record mask pressure.

Oximeter Input The Oximeter input is identified as OXY on the channel label on the back panel. This serial port is a brown, 3 pin, 1 mm touch proof connector. NONIN Oximeter sensors are supported by this input.

Other Internal Sensors Body Position The Embla titanium has a built-in three-dimensional sensor for measuring body position. This internal sensor is used when the Embla titanium is worn on the body. An external body position sensor may also be used in either the bipolar inputs or the DC inputs, depending on the specifications of the body sensor used.

Connectors and Isolation Interfaces titanium USB Interface The isolation interface is connected to the PC via a built-in USB cable and is connected to the Embla titanium via the titanium Interface cable that comes with the system. The BQ USB Interface isolates the acquisition computer from the recorder. This option is used to prepare ambulatory (Holter Mode) recordings and can also be used for online studies where the PC is set up in close proximity to the patient.

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Embla titanium Clinical Manual

titanium Network Interface The titanium USB Network Interface (BQ NET) allows you to connect the Embla titanium to a network and also acts as an isolation interface. This setup is convenient for online studies. The BQ NET can be placed next to the patient's bed with the recorder connected to it via the titanium Interface cable that comes with the system. The BQ NET is connected to the network using an Ethernet cable, and is powered by the titanium AC power supply that plugs into an electrical outlet. This power supply comes with a set of four regional adaptors to allow you to connect it to your local electrical outlet. The acquisition computer can collect the PSG data from another room by connecting to the same network. In this setup, the BQ NET provides isolation and connectivity to the Embla titanium during the study, and the AC power supply powers the recorder. The titanium USB Network Interface has four LED lights on its front panel: the System Status LED and 3 hub LEDs. Each light can display three colors: red, green and orange (associated with firmware upgrades only). Display

Description

Green searching pattern across all LEDs

Searching for host

Solid green

Hub port is powered.

Flashing green and red

Possible connection problem. Contact Embla technical support for assistance: [email protected].

The BQ NET is delivered with the following components: the titanium USB Network Interface, AC power supply with adaptors, Ethernet cable, and an installation CD for BQ NET driver software (including an installation guide).

titanium Interface Cable This black, 3 meter long cable comes with the Embla titanium system and is used to connect the Embla titanium to the BQ USB or BQ NET Interface.

Quick Disconnect Cable The titanium Interface cable can be connected to this short gray cable during online studies. The Quick Disconnect cable is attached to the Embla titanium and extends outside of the recorder's carrying case, making it easy to disconnect the device during studies, allowing the patient to get up out of bed.

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Embla titanium Components Warning: Use only the cables provided with the Embla titanium to connect the device. Using any other cables could compromise electrical isolation and prevent the proper operation of the Embla titanium.

Compact Flash Memory Card A compact flash memory card is provided with the titanium system. Before being used for the first time, the new memory card must be formatted. If a memory card is not formatted, the Embla titanium will prompt the user to format the card. The Embla titanium uses the flash memory card to store data during ambulatory studies. For more information, please see the following sections: •

Inserting and Formatting the Memory Card

•

Recording Duration

•

Memory Card Protection Cover

Batteries AA Batteries The Embla titanium is powered by two non-rechargeable, 1.5V AA alkaline batteries when not powered via the BQ USB and titanium Interface cable connection to the PC or through the BQ NET Interface's AC power supply. The Embla titanium recorder cannot be used with rechargeable batteries. For each study, you must insert two new, 1.5 volt, AA alkaline batteries. These should be replaced after every recording. Not all brands of AA alkaline batteries have the same capacity and may vary in the milliamps the battery can deliver times hours of service, or in dimensions. AA batteries that are too small may cause discontinuous recording. It is important to always use good quality batteries, such as Duracell Plus or Duracell Procell. The Embla titanium requires batteries for Ambulatory (Holter Mode) data collection. 11

Embla titanium Clinical Manual Use of the oximeter (which is powered with the same batteries as the recorder) and the number of the channels recorded may affect battery life. With two new alkaline batteries you can use the recorder up to 24 hours without the oximeter. With the oximeter, the recorder will be powered for approximately 15 hours. It is recommended that you use new batteries before each ambulatory recording. If the batteries are depleted during an ambulatory recording, data collection is automatically stopped with the data collected up to that point stored on the memory card. An acoustical warning is generated and a message is displayed on the LCD screen warning you that the batteries are depleted. For instructions on how to insert the batteries, please see the section Inserting the Batteries. During ambulatory recordings, the following symbols appear on the display: Indicates batteries are charged (the internal bar progressively decreases according to battery level) Indicates batteries are out of charge and must be replaced •

The Embla titanium requires two non-rechargeable 1.5V AA alkaline batteries. These are not included in the system and must be purchased separately.

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The Embla titanium should not be used with rechargeable batteries.

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The battery level displayed on the Embla titanium LCD will not be accurate when the system is connected to a power source other than batteries, e.g. to the PC via the BQ USB Interface and titanium Interface cable, or the BQ NET Interface via the titanium Interface cable.

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Pay attention to the battery polarity wfhen inserting batteries. The polarity requirements are printed on the bottom of the battery holder. Warning: Never use a power supply other than the ones provided through the BQ NET or BQ USB interfaces and 1.5V AA batteries to power the amplifier. Doing so could severely damage the amplifier and present risks to operator and patient safety.

Caution – Conditions for Use of Batteries •

12

Primary alkaline batteries should be replaced after each recording, as they will not have enough electrical charge to run the Embla titanium for a second recording.

Embla titanium Components •

To avoid risk of leakage, batteries should not be stored in the Embla titanium for a prolonged period of time.

Carrying Case The Embla titanium comes with a carry case that allows the patient to wear the device during data collection. The bag helps to protect the device against falls, and also reduces exposure to dust and liquids. It also prevents the patient from accidentally pressing the device's command keys. The carrying case comes with an adjustable shoulder strap for carrying the device, as well as an elastic strap that can be threaded through the back of the case and around the patient so that the unit sits flat against the chest or other area.

13

Assembling the System This section details the connection of the Embla titanium to the PC or BQ NET during ambulatory setup and for online recordings. Assembly should only be done by a trained technician.

Assemble the system on a table beside a computer and conduct some experimental recordings before performing patient studies.

Inserting the Batteries in the Embla titanium To insert the batteries: 1. Remove the battery compartment door on the back panel of the Embla titanium by pressing gently with both thumbs on the compartment door. 2. Place two AA batteries in the compartment. Ensure that the batteries are inserted with the correct polarity. Use the + and - indicators inside the battery compartment as a guide. 3. Replace the battery compartment door by inserting it into the slots along the edge of the opening and pushing gently. Always use fully charged or fresh batteries for each sleep study. The Embla titanium will not power up if the batteries are improperly inserted or if the battery power is low.

Checking the Battery You can verify the amount of charge in the battery by observing the bar that appears at the top of the viewing screen when the Embla titanium is turned on using the keypad. Always check the battery status with the Embla titanium unplugged. Once it is plugged into another power source, the battery status displayed on the LCD will not be accurate. To check the battery level, turn on the Embla titanium recorder before it is connected to the PC. The battery level will be shown on the LCD display. 14