Clinical Manual
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Embletta® Gold Clinical Manual
Embletta Gold Clinical Manual Applies to the Embletta Gold PG System Copyright © 2012 Embla Systems, a division of Natus Medical Incorporated. All rights reserved. Issued December 2012. Printed in USA or Germany. Document Number: D-0709-049, Revision 8.0 Document Item Number: 2815007 Disclaimer This document may contain technical inaccuracies or typographical errors. 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 the products. 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.
Copyright Information in this document, including URL and other Internet website references, is subject to change without notice. Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be altered for any purpose, without the express written permission of Embla. The subject matter in this document is the express property of Embla. Unless specifically provided in any written license agreement from Embla, the furnishing of this document does not give you any license to these trademarks, copyrights, or other intellectual property.
Trademarks All product names appearing on this document are trademarks or registered trademarks owned, licensed to, promoted or distributed by Natus Medical Incorporated, its subsidiaries or affiliates. All other Trademarks are the property of their respective owners.
For assistance, please contact Embla Technical Support ([email protected]).
MANUFACTURER Embla Systems 1 Hines Road, Suite 202 Kanata, ON K2K 3C7 Canada Tel: +1.613.254.8877 Fax: +1.613.270.0627
EUROPEAN REPRESENTATIVE Natus Europe GmbH Robert-Koch-Str. 1 82152 Planegg Germany Tel: +49 089 83942-0 Fax: +49 089 83942-777 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 Power Adaptor ... 4 Classifications and Information ... 4 Safety and Regulatory Information ... 5
System Components ...6 PG System Components ... 6 Recorder Components ... 8 Control Panel ... 9 Integrated Sensor Input Area ... 9 Built-in Batteries ...10
Getting Started ... 12 Installing the Device Driver ...12 Windows Vista® and Windows® 7 ...12 Windows XP® Professional ...13 Installing the Embletta Gold ...14 Charging the Batteries ...15
Performing Studies... 16 Selecting the Study Type ...16 Diagnostic Studies...16 PAP Studies...16 Checking the Batteries ...16 Checking the Battery Lights ...17 Preparing a Study...17 Programming the Embletta Gold for Ambulatory Studies ...18 Connecting the Embletta Gold ...18 Programming the Embletta Gold ...19 Programming the Embletta Gold for Online Studies ...21 Connecting the Embletta Gold ...21 Programming the Embletta Gold ...23 Working with Sensors ...25 Attaching XactTrace Respiratory Effort Sensors ...26 Attaching the Nasal Pressure Sensor ...30 Attaching the Oximeter and Oximeter Flex Sensor ...32 Attaching the Thermistor ...34 Attaching the LM Sensors ...35 Attaching the EKG Sensors ...37 Attaching Isolated DC Cable to the Embletta Gold...38 Attaching the EEG Sensors...39 Checking Sensor Connections...40 Sensors and Trace Names...41 Attaching the Embletta Gold to the Patient ...42 PAP Studies ...43 Connecting the Pressure Tubing ...43 Working with the ResMed Therapy Device ...43 Embletta Gold Clinical Manual | Page i
Contents Ending a Study ...46 Downloading a Study ...46 Removing the Sensors from the Patient ...47
System Maintenance ... 48 Cleaning the Embletta Gold ...48 Environment ...48 Factory Calibration ...48 Disposal ...48 Acoustic and Visual Indicators of the Embletta Gold ...49 Acoustic Indicators ...49 Visual Indicators (LEDs) on the Embletta Gold ...49
CAUTION: ... 52 A 3-button reset should never be executed while the device firmware is being upgraded. This can render the device inoperable. ... 52 CAUTION: ... 52 A 3-button reset should never be executed while the battery charger is plugged into the device. This may cause the device to overcharge and overheat. ... 52 CAUTION: ... 52 A 3-button reset should never be executed while the device is actively recording or being prepared for recording. A study may be completely lost. ... 52 CAUTION: ... 52 Use of the 3-button reset may result in a degradation of the battery life cycle. This function should only be used as a last step before sending the unit in for repair. . 52 Technical Specifications ... 53 Embletta Gold System Properties ...53 Power Adaptor Properties ...53 Nonin Xpod Oximeter Accuracy...54 Materials List ...55
Index ... 56
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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 about 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 about 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.
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Warnings, Cautions, and Certifications Warnings and Cautions
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 magnetic resonance imaging (MRI) environment.
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, radio frequency (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 power 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. Embletta Gold Clinical Manual | Page 2
Warnings, Cautions, and Certifications
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.
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 sleep-related 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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Warnings, Cautions, and Certifications
Certifications Embletta Gold The Embletta Gold is certified to carry the CE mark. The CE mark is a declaration that Embletta Gold is in compliance with the European Union for Medical Device Directive. The Embla Quality Management System complies with EN ISO 13485:2003. The Embletta Gold is manufactured in the United Kingdom for Embla Systems.
2001907 Conforms to UL 60601-1 Cert. to CAN/CSA C22.2, No. 601.1
The Embletta Gold is certified for both the U.S. and Canadian markets to the applicable U.S. and Canadian standards.
Power Adaptor Identified as FWGB Type FW7333M/05. The power adapter is certified to carry the CE mark. In addition, the power adaptor is approved to the following standard: UL/EN/IEC 60601-1.
Classifications and Information 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. 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.
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Warnings, Cautions, and Certifications Mode of operation: Continuous. Where you see this symbol on any device label, it means "Attention: consult accompanying documentation". According to the regulation in Europe on Waste of Electrical and Electronic Equipment (WEEE), the Embletta Gold may not be disposed of as unsorted municipal waste. The Embletta Gold should be returned to Embla when it is ready to be disposal. Contact Embla Technical Support ([email protected]) for more information.
5V
1A
Electrical ratings (battery charger) Where you see this symbol on the device, the date of manufacture is indicated adjacent to this symbol (embedded in the serial number).
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 charge 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 positive airway pressure (PAP) 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. PAP Pressure Tubing. Used to link the Embletta Gold to a flow generator. Connects the PAP 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 PAP 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.
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System Components Component
Description 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.
Recorder Components The following figure identifies the Embletta Gold recorder control panel (front panel) and input area components.
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System Components
Control Panel The Embletta Gold front panel has three buttons and a set of lights as described in Table 2. 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.
Table 3 provides a brief description of the Embletta Gold’s lights. Table 3: Control Panel Lights Light
Description
Battery
Green/red battery light, indicating the battery condition.
Status
Amber/green/red status light, indicating the status of the recorder.
Sensor
Yellow sensor lights, indicating signal quality of the sensor inputs.
For more information about status indicator lights, see Visual Indicators (LEDs) on the Embletta Gold. 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 touch-proof connector
Brown
Serial Online/ResMed Therapy Device
3-pin touch-proof connector
Black
ExG input
1-pin touch-proof connector
Red +, Black -
PGND output
1-pin touch-proof connector
Green
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System Components Sensor
Connection Type
Input Color Code
Thermistor input
2-pin touch-proof keyed connector
Gray
DC 0-1V input
2-pin touch-proof connector
White
XactTrace belt input, Abdomen
2-pin touch-proof connector
Yellow
XactTrace belt input, Thorax
2-pin touch-proof 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.
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 PAP study to collect more precise airflow data.
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 PAP mask to the luer lock on the top of the Embletta. More precise airflow data can be collected during a PAP 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 PAP hose.
Built-in Batteries Warning: Never use an AC power 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.
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System Components Caution: Conditions for battery use Charge the battery until the battery light is solid green 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 power 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 about how to charge the batteries, see Charging the Batteries. If the Embletta Gold is not connected to the computer with a serial or USB cable, or if it is not connected to the power adaptor, and if it is not programmed, the device will switch to sleep mode after ten 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 lifetime is one year; at that point, they should be replaced. Contact Embla Technical Support ([email protected]) for more information about 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® and Windows® 7 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 displays:
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Getting Started
Windows XP® Professional To complete device driver installation: 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 detects the device, and display the following pop-up:
2. Wait for the Found New Hardware Wizard to display.
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.
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Getting Started
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 or 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, then click Next.
5. Enter a name for the new device. 6. Click Next. An overview of device properties displays. 7. Click Finish to close the wizard.
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Getting Started
Charging the Batteries The Embletta Gold’s built-in batteries are charged by connecting the recorder to the power adaptor provided with the device. The power adaptor converts the power received from the electrical outlet to a 5 volt charge to recharge the batteries. To charge the batteries: 1. When using the Embletta Gold power adaptor for the first time, insert the appropriate regional specific plug to the charger input. 2. Plug the adaptor into the electrical outlet. 3. Plug the power adaptor into the 26-pin port connection port on the Embletta Gold. 4. To charge the Embletta Gold batteries for an 8 hour study, leave the device connected to the charger for at least 30 minutes. To charge the Embletta Gold for recordings lasting up to 3 consecutive nights, a charge time of up to 2 hours and 15 minutes might be required. 5. When the Embletta Gold is fully charged, the Battery light on the device displays solid green. The Embletta Gold can now be disconnected from the power adaptor. Warning: Never use an AC power 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 until the battery light is solid green 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 for a minimum of 30 minutes before each 8 hour recording, as they do not maintain their electrical charge for long periods. Charge the batteries for 2 hours and 15 minutes for up to 3 consecutive studies. 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 about the use of the sensors listed below and their placement on the patient. The Embletta Gold system offers two main study types: diagnostic and PAP.
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).
PAP Studies PAP 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 PAP study, instead of the nasal cannula, the pressure tube is connected from the luer lock to the PAP 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 PAP hose. Differential pressure inputs allow the device to record more precise information about flow during the PAP 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 rechargeable batteries provide a minimum recording duration of 8 hours when charged for 30 minutes from any battery state. To record 3 consecutive studies, charge the batteries for 2 hours and 15 minutes. Ensure the batteries are fully charged before connecting the Embletta Gold to the setup computer.
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