Embletta Gold Clinical Manual Rev 5.0 Sept 2010

Embletta Gold Clinical Manual Applies to the Embletta Gold PG System Copyright © 2010 Embla. All rights reserved. Issued 2010-09-15. Printed in The Netherlands. Document Number: D-0709-049, Revision 5.0 Document Item Number: 2815007 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-E, RemLogic, and XactTrace are trademarks of Embla Systems, LLC. Embletta and Embla are registered trademarks of Embla Systems Inc. All other trademarks are the property of their respective owners. The Embletta Gold is manufactured in the United Kingdom for Embla Systems, LLC.

For assistance, please contact Embla Technical Support ([email protected]). MANUFACTURER EUROPEAN REPRESENTATIVE Embla Systems Embla Systems Naritaweg 12J 11001 W. 120th Ave., Suite 200 1043 BZ Amsterdam Broomfield, CO 80021 The Netherlands USA Tel: +31 20 3460130 Tel: +1.303.962.1800 Fax: +31 20 3460121 Fax: +1.303.962.1810 TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632) www.embla.com [email protected] [email protected]

Contents Introduction ...1 Warnings, Cautions, and Certifications ...2 Warnings and Cautions... 2 Intended Use ... 3 Certifications... 4 Embletta Gold... 4 Voltage Adaptor... 4 Classifications ... 4 Safety and Regulatory Information ... 5

System Components...6 PG System Components ... 6 Table 1: Embletta Gold Polygraphy System Components ... 6 Recorder Components ... 8 Control Panel ... 8 Table 2: Control Panel Buttons ... 8 Table 3: Control Panel Lights ... 9 Integrated Sensor Input Area ... 9 Table 4: Sensor Connection Types and Input Color Codes ... 9 Built-in Batteries ...10

Getting Started ... 11 Installing the Device Driver ...11 Windows Vista ...11 Windows XP Professional...11 Installing the Embletta Gold ...12 Charging the Batteries ...13

Performing Studies... 14 Selecting the Study Type ...14 Diagnostic Studies...14 CPAP Studies ...14 Checking the Batteries ...14 Checking the Battery Lights ...15 Preparing a Study...15 Programming the Embletta Gold for Ambulatory Studies ...16 Connecting the Embletta Gold ...16 Programming the Embletta Gold ...17 Programming the Embletta Gold for Online Studies ...19 Connecting the Embletta Gold ...19 Programming the Embletta Gold ...20 Working with Sensors ...22 Attaching XactTrace Respiratory Effort Sensors ...23 Table 5: XactTrace Reusable Belt Dimensions ...24 Attaching the Nasal Pressure Sensor ...26 Table 6: Pressure Transducer Variance for CPAP and Diagnostic Studies ...27 Attaching the Oximeter and Oximeter Flex Sensor ...28 Attaching the Thermistor ...31 Attaching the LM Sensors ...31 Attaching the EKG Sensors ...33 Attaching Isolated DC Cable to the Embletta Gold...34 Attaching the EEG Sensors...35 Checking Sensor Connections ...36 Sensors and Trace Names...37 Table 7: Sensors and Associated RemLogic-E Trace Names ...37 i

Embletta Gold Clinical Manual Attaching the Embletta Gold to the Patient ... 37 CPAP Studies ...38 Connecting the Pressure Tubing ...39 Working with the ResMed Therapy Device ...39 Ending a Study ...42 Downloading a Study ...42 Removing the Sensors from the Patient ...43

System Maintenance ... 44 Cleaning the Embletta Gold...44 Environment ...44 Factory Calibration ...44 Disposal ...44

Technical Specifications ... 45 Embletta Gold System Properties ...45 Table 8: Embletta Gold System Properties ...45 Voltage Adaptor Properties ...46 Table 9: FWGB Type FW7333M/05 Voltage Adaptor Properties ...46 Nonin Xpod Oximeter Accuracy...46 Table 10: Nonin Xpod Oximeter Signal Properties and Accuracy ...46 Materials List ...47 Table 11: Embletta Gold System Materials List ...47

Index ... 48

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Introduction This manual is intended for all users of the Embletta Gold Polygraphy (PG) system and applies to RemLogic-E and the Embletta Gold recording device. The manual includes information on performing sleep studies with the Embletta Gold, including how to attach the sensors to the patient, initialize the recording, and download the data in the acquisition application. The Embletta Gold is a 9-input, 14-channel polysomnographic recorder used to acquire patient physiological signals including respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user-triggered event, and oximetry, during sleep-related studies. The recorder allows for the storage of input channel data to an internal memory or a connected computer. When all 9 inputs are in use, the recorder permits a minimum of 24 recording hours. If the device is connected with a subset of these channels, the number of recording hours permitted will be greater. 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. For more information on any Embla product feature, or for technical support, please contact Embla Technical Support ([email protected]). The Embletta Gold is manufactured in the United Kingdom for Embla Systems Inc.

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Warnings, Cautions, and Certifications Warnings and Cautions

2

•

The Embletta Gold and its components are NOT TO BE USED FOR CONTINUOUS MONITORING where failure to operate can cause injuries or death of the patient.

•

The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies.

•

The system must not be used for direct cardiac contact.

•

Caution: U.S. Federal law restricts this device 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 Embletta Gold should be avoided at all times. The Embletta Gold system is not water resistant, drip-proof, or splash-proof, and the cleaning instructions in this manual must be strictly adhered to.

•

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

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The Embletta Gold and its components 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 Embletta Gold 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 manufacturer.

•

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

•

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 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.

•

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

•

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 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.

Warnings, Cautions, and Certifications •

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

•

If the single-use XactTrace belts are not properly crimped, 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 covered.

•

The single-use XactTrace belt roll may contain junctions where belt parts are joined together with tape. Sections containing junctions 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.

•

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

•

As a result of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care and other environments, high levels of interference, due to close proximity or strength of the source, may disrupt the performance of the Embletta Gold. For these reasons, special precaution regarding EMC is needed when the device is installed and put into service.

•

While the Embletta Gold 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 isolated DC cable is required when recording signals from DC devices that are connected to AC power (mains power).

•

Do not connect DC devices that require AC mains power directly to the Embletta Gold.

•

The battery life of the Isolated DC cable is 40 hours. When the battery dies or is not present, the circuit stops functioning, and no signals will record. When the cable is not in use, move the on/off switch to the “off” position to conserve battery life.

•

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.

•

Remove the batteries from the isolated DC cable if the product is not in use for an extended period of time.

Intended Use The Embletta Gold is a digital recording device designed to be applied by a layperson under the direction of a physician or trained technician. The Embletta Gold records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleeprelated medical disorders by trained personnel. The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor. The intended environments include any clean, dry, dust free environment suitable for a patient’s relative comfort.

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Embletta Gold Clinical Manual

Certifications Embletta Gold 0413

The Embletta Gold is certified to carry the CE mark. The CE mark is a declaration that Embletta Gold 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 13485:2003. The Embletta Gold is manufactured in the United Kingdom for Embla Systems Inc.

The Embletta Gold is an RoHS compliant, lead-free product.

The Embletta Gold is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.

Voltage Adaptor Identified as FWGB Type FW7333M/05. The voltage adapter is certified to carry the CE mark. In addition, the voltage adaptor is approved to the following standard: UL/EN/IEC 60601-1.

Classifications The following classifications apply to the Embletta Gold: Embletta Gold is classified as internally powered equipment. The Embletta Gold is classified as a Class IIa medical device according to the Medical Device Directive (MDD) of the European Union. The Embletta Gold is classified as 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 Embletta Gold 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 Embletta Gold is not suitable for use in presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE. Mode of operation: Continuous. 4

Warnings, Cautions, and Certifications 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 Embletta Gold should be returned to Embla when it is ready to be disposed of. Contact Embla Technical Support ([email protected]) for more information. Where you see this symbol on the device, it means that the date of manufacture is indicated adjacent to this symbol.

Safety and Regulatory Information Before using the Embletta Gold PG system, please read this clinical manual carefully, paying particular attention to the caution or warning that appears with each safety symbol. 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. 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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System Components PG System Components The following table outlines Embletta Gold PG system components. Table 1: Embletta Gold Polygraphy System Components Component

Description Embletta Gold. A pocket-sized digital recording device designed to record patient sleep study data for the purpose of subsequent display and manual diagnosis of sleep-disordered breathing, such as obstructive sleep apnea.

3-in-1 Cable. Used for online and ResMed Therapy Device studies and firmware upgrades. Ordered separately. Contact your Embla representative for more information.

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

Power Adaptor. Provides power to the Embletta Gold built-in rechargeable batteries.

Elastic Strap. Used to fasten the Embletta Gold on the patient.

Isolated DC cable. Interfaces external devices to the Embletta Gold. The isolated DC cable is required when connecting any external medical device that is not self powered/battery powered, such as a CPAP device, CO2 monitors, and other devices that use a power supply connected to AC power (mains power).

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System Components Component

Description Carrier Bag. Used to store and carry the Embletta Gold system.

Nonin XPOD Oximeter and Oximeter Flex Sensor. Used to measure the degree of oxygen saturation of the circulating blood. The Embletta Gold only supports the Nonin XPOD oximeter, although other Nonin oximeter sensors can be used. Nasal Cannula. Latex free, single-use nasal pressure cannula used to measure airflow. Connects to the luer lock on the Embletta Gold.

XactTrace™ Sensor. Embla proprietary respiratory effort sensor used to measure patient thorax and abdominal movement. The only respiratory effort sensor supported by the Embletta Gold. CPAP Pressure Tubing. Used to link the Embletta Gold to a flow generator. Connects the CPAP mask to the luer lock on top of the Embletta Gold.

Differential Pressure Tubing and adaptor. Used to link the Embletta Gold differential pressure inputs to the CPAP mask tube and detect changes in pressure.

EEG Electrodes. Single-use, disposable EEG electrodes with cable. 100 cm (40 in; Ag/AgCl (silver/silver chloride) wet gel. Other quality electrodes meeting these specifications can be used with the Embletta Gold. EKG Snap-on Cables. 2 snap-on cables; Orange color coding; Black button snap; Orange 1.5 mm connector; 1.98 m length (78 in); Latex free. Electrodes. Solid gel LM/EKG electrodes; Circular shape; Diameter 4.8 cm (1.9 in); Single-use, Latex free; Hypoallergenic; To be used with snap-on cables. Other quality LM/EKG electrodes meeting these specifications can be used with the Embletta Gold. LM Snap-on Cables. 2 snap-on cables; Black color coding; Black button snap; Black 1.5 mm connectors; 3 m length (120 in); Latex free. Electrodes. Solid gel LM/EKG electrodes; Circular shape; Diameter 4.8 cm (1.9 in); Single-use; Latex free; Hypoallergenic; To be used with snap-on cables. Other quality LM/EKG electrodes meeting these specifications can be used with the Embletta Gold. Ground Snap-on Cable. Green color coding; Black 1.5 mm connector; Available in 0.99 m (39 in) or 1.98 m (78 in) lengths. 7

Embletta Gold Clinical Manual

Recorder Components The following figure identifies the Embletta Gold recorder control panel (front panel) and input area components. 1

2

3

4

5

7

6

8

9

10

14 15 11

12 17 16

13

1 thoracic respiratory effort input

10 patient ground (PGND)

2 abdominal respiratory effort input

11 event button

3 DC input

12 power button

4 thermistor input

13 test button

5 oximeter input

14 battery light

6 online input (AutoSet interface)

15 status lights

7 differential pressure sensors

16 sensor lights

8 pressure luer lock (flow sensor)

17 connection port

9 ExG sensor input (EMG, EKG, EEG)

Control Panel The Embletta Gold front panel has three buttons and a set of lights as described in Tables 2-3. Table 2: Control Panel Buttons Button

Description

Start

Used by the patient to start and stop a recording (if specified in the programming of a recording).The button is disabled when a recording has been programmed to start at a specified time or immediately. If the Embletta Gold is in sleep mode, pressing the Start button will wake the device (and activate the green status light).

Test

Initiates the signal test.

Event

Used by the patient to time-stamp events during a sleep study. Instruct the patient to press the Event button to record the occurrence of an event such as lights off or lights on.

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System Components Table 3: Control Panel Lights Light

Description

Battery

Green/red battery light, indicating the battery condition.

Status

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

Sensor

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

For more information on lights and their use in testing signal quality, see Checking Sensor Connections. Tip: A red status light and a red battery light indicate an error that requires immediate attention.

Integrated Sensor Input Area Table 4 lists sensor connection types and input color codes. Table 4: Sensor Connection Types and Input Color Codes Sensor

Connection Type

Input Color Code

Oximeter

3-pin touchproof connector

Brown

Serial Online/ResMed Therapy Device

3-pin touchproof connector

Black

ExG input

1-pin touchproof connector

Red +, Black -

PGND output

1-pin touchproof connector

Green

Thermistor input

2-pin touchproof keyed connector

Gray

DC 0-1V input

2-pin touchproof connector

White

XactTrace belt input, Abdomen

2-pin touchproof connector

Yellow

XactTrace belt input, Thorax

2-pin touchproof connector

Blue

Nasal pressure input

Luer-lock female

n/a

Differential pressure inputs

2x 1/8 inch hose barbs

n/a

USB and charging input

26-pin Molex connector

n/a

Body Position Sensor The built-in body position sensor collects X-Y gravity information that measures the patient's angle and elevation (whether standing or horizontal). A third activity trace is derived from this data and represents position changes. A high value in the activity trace represents a substantial change in position and a low value represents a small change in position.

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Embletta Gold Clinical Manual

Pressure Luer Lock and Differential Pressure Sensor The luer lock, located on top of the Embletta Gold, connects to a built-in pressure sensor. The pressure signal can come from a nasal cannula or a flow generator mask. Adjacent to the luer lock are two ports for attaching a differential pressure sensor, which can be used during a CPAP study to collect more precise airflow data.

Luer Lock

Embletta Gold (front view) displaying the Luer lock and differential pressure sensor ports

Pressure Tubing A flow generator is connected to the Embletta Gold to measure the airway pressure delivered by the flow generator. To link the recorder to a flow generator, pressure tubing is used. It is connected from the CPAP mask to the luer lock on the top of the Embletta. More precise airflow data can be collected during a CPAP study by measuring differential pressure using the corresponding differential pressure ports on the Embletta. Two line pressure tubes can be connected from these ports to the differential pressure adaptor on the CPAP hose.

Built-in Batteries Warning: 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. Caution: Conditions for battery use Charge the battery for a minimum of two hours before using the Embletta Gold for the first time or if device is left unused for a week or more. Rechargeable batteries should be charged before each recording as they do not maintain their electrical charge for long periods. The Embletta Gold comes with two built-in AA rechargeable Nickel Metal Hydride (NiMH) batteries, a built-in battery charger, an AC voltage adaptor (FWGB Type FW7333M/05) and two input cords to accommodate local power environments. The batteries provide a minimum recording duration of 8 hours when re-charged for 30 minutes from any battery state. When fully charged, the batteries can power the Embletta Gold for a minimum of 24 hours of recording. A USB cable is provided with the Embletta Gold which connects the device to the computer for programming and downloads. This cable also sends a trickle charge to the built-in batteries. This trickle charge will keep fully-charged batteries "topped up" while the recorder is connected to the computer. For instructions on how to charge the batteries, see Charging the Batteries. When the Embletta Gold is not connected to the computer via serial or USB cable, or to the voltage adaptor, the device will switch to sleep mode after several minutes of inactivity to save power. Pressing the Start button will activate the status light. If programmed to start recording at a specified time, the device will switch from sleep mode to recording mode at that time. In sleep mode, the batteries will maintain their charge for approximately two weeks. The battery service lifetime is at least 500 studies, based on an average recording duration of 8 hours. This corresponds to 2 years of use at 250 studies per year. Contact Embla Technical Support ([email protected]) for more information on battery replacement.

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Getting Started Installing the Device Driver The installation of a USB device driver is required to allow the operating system to communicate with the Embletta Gold. When the Embletta Gold is connected to the computer with the USB download cable for the first time, you will be prompted for a device driver for the new device. Although the device driver is installed with the software used to program the Embletta, the driver requires activation for each device connected.

Windows Vista To complete the installation of the device driver: •

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

After the device is automatically installed, the following popup is displayed:

Windows XP Professional To complete the installation of the device driver: 1.

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

2.

Wait for the Found New Hardware Wizard to appear.

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Embletta Gold Clinical Manual 3.

Ensure the Install the software automatically option 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 Embletta Gold can now be used with the system.

Installing the Embletta Gold The Embletta Gold is intended to be used in conjunction with RemLogic-E, a polygraphy application that assists in the preparation and analysis of Embletta recordings; however, the use of RemLogic in conjunction with the Embletta Gold is required for online studies and EEG data analysis. To install Embletta Gold: 1. Open RemLogic-E/RemLogic. 2. Connect the isolated USB download cable to the Embletta Gold connection port (located to the right of the device status lights). 3. Connect the isolated USB download cable connector to a computer USB port. The New Device Wizard will automatically detect the new device. 4. Select the Embletta Gold device, and then click Next.

5. Enter a name for the new device. 6. Click Next. An overview of device properties is displayed. 7. Click Finish to close the wizard.

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Getting Started

Charging the Batteries The built-in batteries of the Embletta Gold are charged by connecting the recorder to the voltage adaptor provided with the device. The voltage adaptor converts the power received from the electrical outlet to a 5 volt charge (required by the built-in battery charger). To charge the batteries: 1. When using the Embletta Gold voltage adaptor for the first time, connect the plug to the adapter input. 2. Plug the adaptor into the electrical outlet. 3. Plug the voltage adaptor into the 26-pin port connection port on the Embletta Gold. 4. To fully charge the Embletta Gold batteries, leave the device connected to the charger for 30 minutes. The batteries may require a longer charge time (>30 minutes) for recordings longer than 8 hours. 5. When the Embletta Gold is fully charged, the battery indicator light on the device will display green. The Embletta Gold can now be disconnected from the voltage adaptor. Warning: 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. Caution: Conditions for use of batteries Charge the battery for a minimum of two hours before using the Embletta Gold for the first time or if device is left unused for a week or more. Rechargeable batteries should be charged before each recording as they do not maintain their electrical charge for long periods. 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.

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Performing Studies Selecting the Study Type Preparing an Embletta Gold sleep study involves programming the Embletta Gold and attaching sensors to the patient. The Embletta Gold system assists in the collection of respiratory data along with one channel of LM, EKG or EEG data. The Embletta Gold can be adapted to a variety of studies. Depending on the type of study selected, different sensors and additional interfaces are used. Below is a description of common study setups. See Working with Sensors for detailed instructions on the use of the sensors listed below and their placement on the patient. The Embletta Gold system offers two main study types: diagnostic and CPAP.

Diagnostic Studies During diagnostic studies, data is collected to assist in identifying and diagnosing sleep disordered breathing. One channel of ExG can be recorded to detect PLM. This single channel can also be used to collect EKG or EEG data. The Embletta's sensor input area allows you collect data using a variety of sensors, including XactTrace respiratory effort sensors, an oximeter, a nasal cannula to measure flow and snore pressure, and a thermistor (optional).

CPAP Studies CPAP studies can be performed with a flow generator to measure the effectiveness of treatment, and to collect respiratory, position, and oxygen saturation information with the Embletta Gold. When performing a CPAP study, instead of the nasal cannula, the pressure tube is connected from the luer lock to the CPAP mask to record the mask pressure. In addition, a differential pressure sensor can be connected from the corresponding ports on the Embletta Gold to the differential pressure adaptor on the CPAP hose. Differential pressure inputs allow the device to record more precise information about flow during the CPAP study. The ResMed Therapy Device can also be used to measure the following ResMed Therapy Device signals: RMD Flow, RMD Pressure, RMD Leak, RMD Snore, and RMD Flattening. For more information, see Working with the ResMed Therapy Device.

Checking the Batteries The built-in AA rechargeable batteries provide a minimum recording duration of 8 hours when re-charged for 30 minutes from any battery state. During the programming of the Embletta Gold, the battery voltage is verified by the software application (RemLogic/RemLogic-E) and displayed in the Recording Wizard. Ensure the batteries are fully charged before connecting the Embletta Gold to the setup computer.

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Performing Studies

Checking the Battery Lights The battery lights on the front panel of the Embletta indicate the battery charge status:

Green LED •

Flashes each half-second when fast charging

•

Glows steadily when charge completed

•

Flashes in short bursts every two seconds during trickle charge (when the USB cable is plugged in)

Red LED •

Flashes when the batteries need to be recharged

Preparing a Study To prepare a study, you will need to enter information on the patient undergoing the study. In RemLogic and RemLogic-E, this step is initiated by clicking Patient Information on the Operations sheet. Before programming the Embletta Gold, this step must be complete. To enter patient information in RemLogic/RemLogic-E: 1. On the Operations sheet, click Patient Information. 2. Enter the patient's name, ID number, date of birth, gender, and body metrics. 3. Click the Home tab. Enter the patient's address, telephone numbers, and email address. 4. Do one of the following: •

If you are using RemLogic, click the Custom tab. Enter the values for customized patient information parameters to be used in reports. For more information, see Adding Patient Information Fields in the RemLogic User Manual.

•

If you are using RemLogic-E, proceed to step 5.

5. Click the Notes tab. Enter comments or notes that you want to display in the comment section of RemLogic-E's active reports. 6. Click the Summary tab to review a summary of the patient information. 7. Click OK. To prepare a study for a patient with an existing patient record: •

In the Recording Manager, right-click the patient's folder, and then click New Study.

In RemLogic/RemLogic-E, a Patient folder is created for the patient in the active data location in the Recording Manager. The Patient folder contains a Recording folder labeled Unknown until the Embletta has been prepared.

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Embletta Gold Clinical Manual

Programming the Embletta Gold for Ambulatory Studies Before connecting and programming the Embletta Gold for an ambulatory study, you will need to install the device and enter patient information relevant to the study. See the following topics for more information: •

Installing the Embletta Gold

•

Preparing a Study

Connecting the Embletta Gold Desktop To connect the Embletta Gold to a desktop computer: 1. Connect the isolated USB download cable to the Embletta Gold connection port (located to the right of the device status lights). 2. Connect the isolated USB download cable connector to a computer USB port.

Laptop When using the Embletta Gold with a laptop computer, use a self-powered USB hub to ensure the USB voltage is adequate for reliable interface and downloads. Caution: For continued patient isolation and protection, first connect the Embletta Gold to the isolated USB download cable, and then connect the powered hub. To connect the Embletta Gold to a laptop computer: 1. Connect the isolated USB download cable to the Embletta Gold connection port (located to the right of the device status lights). 2. Connect the isolated USB download cable connector to a USB port on the powered USB hub. 3. Plug the hub USB connector into a USB port on the computer. 4. To power the USB hub, connect it to an electrical outlet.

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