Embletta and Proxies Clinical Manual Rev 4.0 May 2008

Embletta and Proxies Clinical Manual Applies to the Embletta Copyright © 2008 Embla. All rights reserved. Issued May 2008 Document #: D-0703-024, Revision 4.0 Document Item #: 2815005 Embla 11001 W. 120th Ave.

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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 REMbrandt, Embletta, and Embla are registered trademarks of Embla Systems Inc. RemLogic, RemLogic-E, and XactTrace are trademarks of Embla Systems Inc. AutoSet is a registered trademark of ResMed Inc. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

Contents About This Manual ...1 System Requirements...2 Embletta System Components...3 Embletta Recorder Components...6 Control Panel... 6 Buttons ... 6 Lights... 6 Interfaces... 7 Pressure Luer Lock... 7 Pressure Tubing ... 8

Warnings, Cautions and Contraindications ...9 Safety and Regulatory Information... 9 Warnings and Cautions... 9 Intended Use ...11 Certifications...12 Classifications ...12

Setting up the System... 14 Connecting the Embletta to the Computer...14 Installing the Device Driver...14 Connecting the Embletta for Online Studies ...17 Disconnecting the Online Interface During the Study...18 Installing the Embletta in the Software ...19

Preparing a Study ... 21 Embletta X100 System ...21 Study Configurations - X100 System ...21 Sleep Configuration ...22 Sleep EKG Configuration ...23 Sleep PLM Configuration ...24 Cardio Configuration...25 Study Configurations - Other Proxies ...26 Preparing the Recorder ...27 Inserting the Batteries in the Embletta ...27 Entering Patient Information ...29 Programming the Embletta...30 i

Embletta and Proxies Clinical Manual Attaching the Sensors - X100 System ...33 Attaching the Electrodes ...33 Selecting Electrode Locations...34 Sleep Electrodes ...35 Sleep EKG Electrodes ...36 Sleep PLM Electrodes ...39 Cardio Electrodes...40 Attaching Sensors - Other Proxies ...43 LM Sensors...43 EKG Sensors...44 EEG Sensors ...46 Thermistor ...47 Snoring Sensor ...48 Attaching XactTrace™ Respiratory Effort Sensors...50 XactTrace Single Use Belts ...50 Attaching the Single Use XactTrace Belts...51 Considerations for Use: ...52 Attaching the XactTrace Reusable Belts...53 Attaching Oximeter and Oximeter Flex Sensor...55 Attaching the Oximeter Flex Sensor...56 Other Oximeter Sensors ...58 Attaching Nasal Pressure Sensor...59 Performing a CPAP Study ...60 Connecting the Pressure Tubing...61 Using the Embletta AutoSet Interface...61 Inserting the Proxy ...64 Checking Sensor Connections ...64 Attaching the Embletta to the Patient...65

Ending the Study ... 67 Removing the Sensors from the Patient...67 Cup Electrodes...67 Single Use Electrodes ...67 Downloading the Study...68

System Maintenance ... 70 Cleaning the Embletta ...70 Environment...70 Factory Calibration...71 Disposal ...71

Technical Specifications ... 72 Embletta System Properties...72 ii

Contents Oximeter Accuracy for Type Nonin Xpod...73 Embletta System Materials List ...73

Sensors and Trace Names Reference ... 75 Sensors and Trace Names ...75

Embletta Proxies Reference... 77 X10 Proxy...77 X20 Proxy...78 X30 Proxy...80 X50 Proxy...81 X100 Proxy ...82

Glossary ... 84 Index... 86

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About This Manual This Clinical Manual is intended for users of the Embletta PG System. The manual includes information on how to perform a sleep study with the Embletta and its proxies. It describes how to attach the sensors to the patient, initialize the recording, and download the data in the acquisition application. 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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System Requirements To record ambulatory studies with the Embletta and its proxies (other than the X100), you must have RemLogic-E™ or the Embletta Configuration for REMbrandt® installed on your computer. To record with the X100 Proxy, you must have RemLogic 1.0 installed on your computer. Your Embletta must be equipped with firmware 242 or higher and your Embletta serial number must contain -EB2 in order to use the X100 proxy. For information on verifying and upgrading the firmware, please see the Embletta Firmware Upgrade Instructions. If you are using RemLogic, the instructions can be found in the Embla documentation folder on your hard drive: C:/Program Files/Embla/RemLogic/Documentation.

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Embletta System Components The Embletta X100 System is delivered complete with the following accessories and RemLogic. Recording System

Embletta

Serial Download Cable Used to upgrade the Embletta firmware.

Download Cable Extension If the COM port and keyboard port are wide apart, extends the keyboard port of the Serial Download Cable so it can be plugged in.

USB Download Cable Used to program the Embletta for a recording and to download data.

Leather Holster

Soft Pad

Elastic Strap

Carrier Bag

Used to fasten the Embletta to the patient and to protect it.

Placed between the Embletta and the patient for increased patient comfort and to protect the sensor wires.

Used to fasten the Embletta on the patient.

Used to store and carry the Embletta system.

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Embletta and Proxies Clinical Manual Sensors

X100 Proxy

Other Proxies

All external sensors connect to the proxy.

The Embletta can be used with the X10, X20, X30, X50, and Z10 .

Oximeter Flex Sensor Used to measure the degree of oxygen saturation of the circulating blood.

Nasal Cannula

CPAP Pressure Tubing

EEG Electrodes

Used to link the Embletta to a flow generator. Connects the CPAP mask to the Luer Lock on top of the Embletta.

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Connects to the Luer Lock on the Embletta to measure the pressure.

Common Reference Jumper Leads One- and two-port jumper. Used to connect two inputs and reference to a common electrode. (Used with the X100 proxy)

Oximeter Used to measure the degree of oxygen saturation of the circulating blood.

XactTrace™ Lock Abdomen and XactTrace Belt

XactTrace™ Lock Abdomen and Used to measure the patient's XactTrace Belt chest/abdominal movements. Used to measure the patient's chest/abdominal movements.

EKG Snap On Cables

LM Snap On Cables

Embletta System Components Electrode Application

Alcohol Prep Pads Used to prepare and clean electrode sites.

Disposable Electrodes LM/EKG To be used with the snap on cables.

NuPrep Skin Prepping Gel

Ten20 EEG Conductive Paste

An abrasive gel used when preparing the electrode sites. Adhesive paste that reduces skin impedance. Used with nondisposable neurodiagnostic electrodes.

Cotton Tip Applicators

Gauze

Cable Wrap

For electrode application.

For electrode application.

Used to manage electrode leads and sensor wires during the sleep study.

Marker Pens

Medical Tape

Measuring Tape

Can be used to secure sensors on the patient.

5

Embletta Recorder Components Control Panel The Embletta front panel has three buttons and a set of lights.

Buttons Embletta Front Panel Buttons Symbol

Function The Start Button can be used by the patient to start and stop a recording if this has been specified in the programming of a recording. The button is disabled when a recording has been programmed to start at a specific time or start immediately. The Test Button initiates the signal test. The Event Button is used by the patient to time-stamp events during a sleep study. The patient should be instructed to press the Event button to record the occurrence of an event such as "lights off" or "lights on".

Lights There are three types of lights: •

Sensor lights: Yellow sensor lights, indicating signal quality of the sensor inputs.

•

Status light: Yellow – green/red status light, indicating the status of the recorder.

•

Battery light: Green/red battery light, indicating the battery condition.

For further information about lights and their use in testing signal quality, please refer to the section Checking Sensor Connections.

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Embletta Recorder Components



A red status light or a red battery light indicates a condition that requires immediate attention.

Interfaces Two types of connection interfaces are located on the top of the Embletta: •

A multiple pin port that connects to the desired proxy. The cables are inserted into this same port to connect the Embletta to the computer when preparing and downloading a recording.

•

A Luer Lock that connects to a nasal pressure cannula or a flow generator with pressure tubing.

Pressure Luer Lock The Luer Lock on top of the Embletta connects to a built-in pressure sensor. The pressure signal can come from a nasal cannula or a flow generator mask. For a CPAP study, pressure tubing must be used.

Frontal view of Embletta's top showing the Luer Lock.

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Embletta and Proxies Clinical Manual

Pressure Tubing A flow generator is connected to the Embletta to measure the airway pressure delivered by the flow generator. To link the recorder to a flow generator, CPAP pressure tubing is used. It is connected from the CPAP mask to the Luer Lock on the top of the Embletta.

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Warnings, Cautions and Contraindications Safety and Regulatory Information Before using the Embletta, 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.

Warnings and Cautions The following warnings and cautions are applicable to the Embletta system: •

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

•

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 Embletta and its components are not intended for use in an oxygen tent or 9

Embletta and Proxies Clinical Manual any other enclosed oxygen-enriched environment.

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•

The Embletta and its components do 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.

•

Never use an AC voltage adaptor other than the one provided for the Embletta Gold for recharging the Embletta Gold batteries. Doing so could severely damage the Embletta Gold and present risks to operator and patient safety.

•

The system must NOT be used for direct cardiac contact.

•

The Embletta and its components are not defibrillator proof.

•

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

•

The oximeter sensor site should be changed at least once every 24 hours to prevent skin irritation.

•

Do not use the battery charger when the Embletta Gold is attached to the patient. The Embletta Gold may get warm during charging, and the battery charger cord may present a tripping hazard.

•

Do not use damaged sensors or accessories.

•

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.

•

Electrostatic discharges (ESD) may cause artifacts in the signal from the device. A trained operator should be able to recognize these artifacts easily. Avoid conditions where electrostatic charge can build up because of low humidity and friction against carpets, clothing, and sheets made from artificial fibers.

•

The conductive part of electrodes, the proxy and their connectors, including the ground electrode, must not contact other conductive parts including earth.

•

If the crimping of the single use XactTrace belts is not properly done, data may not be recorded. Crimping refers to the process of inserting the cut end of the belt into the catch of the Belt Lock and tightening until the white pin is partly

Setting Up the System covered. •

The single use XactTrace belt roll may contain junctions where belt parts are joined together with a tape. Sections containing junction should not be used for respiratory measurements. When cutting from the roll to make a belt for a patient, make sure there are no junctions in the belt.

•

The XactTrace belts are intended to be worn over the patient's nightclothes.

•

The Embletta and its components are classified as ordinary equipment regarding ingress of liquids, that is, it is not drip-proof, splash-proof or watertight. During use of device avoid all unnecessary contact with moisture.

•

Because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care 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.

•

While the Embletta is recording, it is not advisable to use mobile phones, transmitters, and similar equipment that generate RF fields in close proximity to the device.

•

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

•

Do not use the Embletta and its components in an MRI environment.

•

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

Intended Use The Embletta is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. Trained personnel use the displayed data to assist in identifying sleep-related medical disorders. The intended environments include any clean, dry, dust free environment suitable for a patient’s relative comfort. 11

Embletta and Proxies Clinical Manual The recorder does not provide any alarms and is not intended to be a life monitor. The Embletta system offers a variety of proxies for different kinds of studies, for example LM and EKG studies. The pressure sensor in the Embletta can monitor air pressure either via nasal cannula or from the patient's mask during treatment with an airflow generator (CPAP or bilevel). The Embletta AutoSet Interface has been designed to connect directly between the Embletta and ResMed's AutoSet device.

Certifications The Embletta is certified to carry the CE mark. The CE mark is a declaration that Embletta is in compliance with the essential requirements set forth by the European Union for medical devices. The Embla Quality Management System complies with EN ISO 9001:2000 and EN ISO 13485:2003. The Embletta is manufactured by Embla. The ETL mark is a symbol of safety and shows that ETL has independently tested and certified the product’s compliance 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.

Classifications Embletta is classified as internally powered equipment. According to the degree of protection against electric shock the Embletta is classified as of type CF. 12

Setting Up the System Ingress of liquids: The Embletta is classified as an ordinary equipment regarding ingress of liquids, that is, it is not drip-proof, splash-proof or watertight. Mode of operation: Continuous. 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 any device label, it means "Attention: consult accompanying documentation".

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Setting up the System Connecting the Embletta to the Computer To program the Embletta for ambulatory studies, first connect it to the acquisition computer with the USB download cable. If you are using the Embletta with a notebook computer, you must use a self-powered USB hub to ensure that the USB voltage is high enough for reliable interface and downloads with the Embletta. Self-powered USB hubs have a wall plug transformer included. The transformer must be plugged in when using the Embletta. To connect the Embletta to the computer: 1. Connect the USB connector of the cable to the USB port of your computer. If you are using a laptop computer, use a self-powered USB hub when connecting the Embletta. 2. Connect the other end of the cable to the port on top of the Embletta. The arrow on the cable's connector should face forward.

Installing the Device Driver A USB device driver needs to be installed on your computer to allow your operating system to communicate with the Embletta. When you first connect the Embletta to your computer with the USB download cable, it will prompt you for a device driver for the new device. The device driver is installed with the software you use to program the Embletta, but needs to be activated for each device that is connected. Windows XP Professional To complete the installation of the device driver: 1.

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Connect the Embletta to a USB port on your computer. The arrow on the cable's device connector should face front. Windows XP will detect the device and display the following pop-up:

Setting Up the System

2.

Wait for the Found New Hardware Wizard to appear.

3.

Make sure that Install the software automatically is selected. Click Next to continue.

4.

Wait for the wizard to locate and install the driver files.

5.

Click Finish to complete the wizard. The hardware driver has been installed and the Embletta device can now be used with your system.

Windows 2000 Professional To complete the installation of the device driver: 1. Connect the Embletta to a USB port on your computer. The arrow on the cable's device connector should face front. Windows 2000 will detect the device and display a window similar to this:

2.

Wait for the Found New Hardware Wizard to appear.

3.

Click Next to continue. 15