Embletta MPR Multi Parameter Recorder Instructions for Use Rev 7.0 July 2014

Embletta MPR Multi Parameter Recorder Instructions for Use Copyright © 2014 Embla Systems, a division of Natus Medical Incorporated. All rights reserved. Issued July 2014. Printed in the USA or Germany. Document Number: D-1205-002, Revision 7.0 Document Item Number: 011246, Revision F

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 EUROPEAN REPRESENTATIVE Embla Systems Natus Europe GmbH 1 Hines Road, Suite 202 Robert-Koch-Str. 1 Kanata, ON K2K 3C7 82152 Planegg Canada Germany Tel: +1.613.254.8877 Tel: +49 089 83942-0 Fax: +1.613.270.0627 Fax: +49 089 83942-777 TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632)

www.embla.com

[email protected]

[email protected]

Table of Contents

Table of Contents Introduction ... 1 About the Embletta MPR... 1

Warnings, Cautions, and Contraindications ... 2 Warnings and Cautions ... 2 Intended Use ... 3 Safety and Regulatory Information ... 3 Essential Performance ... 3

System Components ... 4 Embletta MPR System ... 4 Embletta MPR PG System ... 6 TX Proxy Unit... 8 ST Proxy ... 9 ST+ Proxy ... 10 Embletta MPR Sensors ... 10 Embletta MPR and MPR PG Data Connectors, Display and Buttons ... 11 Embletta MPR and MPR PG Front Display and Buttons ... 11 Embletta MPR Rear Label... 11 Embletta MPR USB connection ... 12 TX Proxy Unit Connections ... 12 ST/ST+ Proxy Connections ... 13

Sensor Connectors ... 13 Embletta MPR ... 13 Embletta MPR PG ... 14 TX Proxy Unit ... 15 ST Proxy Sensor connectors ... 15 ST+ Proxy Sensor Connectors ... 16

Basic Configuration ... 17 Inserting Batteries into the Embletta MPR or MPR PG... 17 Battery Usage... 18 Internal Memory... 18 Configuring an Embletta MPR System ... 18 BlueTooth Configuration ... 19 IP Network Settings ... 20

Recording Modes ... 21 Auto Start Mode ... 21 Scheduled Start Mode ... 21

Embletta MPR Menu Functions ... 22 Main Page ... 22 Recording Status Page ... 24 i

Table of Contents Signal Test Page... 25 Visualization of the test results... 25

Signal Page... 26 Signal Value Page ... 26 Device Info Page ... 27 Signal Quality Level (SQL) Page ... 29

System Maintenance ... 30 System Maintenance ... 30 Cleaning Instructions ... 30 Factory Calibration ... 30 Disposal ... 30

Technical Specifications... 31 Embletta MPR Technical Specifications ... 31 Embletta MPR PG Technical Specifications ... 33 TX Proxy Unit Technical Specifications ... 35 ST Proxy Technical Specifications ... 37 ST+ Proxy Technical Specifications ... 39

Electromagnetic Compatibility ... 41 Embletta MPR and MPR PG ... 41 EMC Emissions ... 41 EMC Immunity ... 41 RF Immunity... 43 Recommended Separation Distances ... 44

TX Proxy Unit... 45 EMC Emissions ... 45 EMC Immunity ... 45 RF Immunity... 47 Recommended Separation Distances ... 48

ST Proxy and ST+ Proxy... 49 EMC Emissions ... 49 EMC Immunity ... 49 RF Immunity... 51 Recommended Separation Distances ... 52

Electrostatic Discharge Handling & Procedures ... 53 Certifications and Classifications ... 54 Certifications ... 54 Classifications ... 54

Index ... 55

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Introduction

Introduction This manual provides instructions for use for the Embletta MPR recording device, safety and regulatory information, and technical specifications. It is assumed that you have a basic knowledge of the Windows® environment, working with the mouse, using toolbars, and arranging windows. Sections typically begin with an overview of main features, followed by instructions in simple action steps.

About the Embletta MPR The Embletta MPR system is a modular recording system consisting of one or several discrete components. These components include: Component

Description

Embletta MPR

The smallest and simplest unit. It is intended to be used alone and has no connectivity to the other components and no wireless capability. This is the base Embletta MPR unit.

Embletta MPR PG

The initial building block for the rest of the system. It is similar to the Embletta MPR base unit but has additional channels, a connector for the ST or ST+ Proxy, as well as wireless capability for connection to the TX Proxy Unit.

TX Proxy

Used to interface the Embletta MPR PG unit with therapy devices, a differential pressure transducer and additional DC inputs for auxiliary devices. Additionally, it acts as a gateway between the Embletta MPR PG unit and the computer. The TX Proxy Unit is connected to the local area network (LAN) and host computer through an Ethernet cable. It is wirelessly paired with the Embletta MPR PG unit using a BlueTooth connection.

ST Proxy

When combined with the MPR PG unit, the ST Proxy provides several additional EEG, EOG, EMG, and ECG channels in a minimal “sleep time” configuration.

ST+ Proxy

When combined with the MPR PG unit, the ST+ Proxy provides a fully AASM compliant recording configuration with additional EEG, EOG, EMG, and ECG channels.

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Warnings, Cautions, and Contraindications

Warnings, Cautions, and Contraindications Warnings and Cautions Consider the following when using the Embletta MPR System. 

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



The Embletta MPR and its components are intended for adult and pediatric (excluding neonatal and infant) studies.



The Embletta MPR must not be used for direct cardiac application, and is not defibrillator proof.



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



Except for the battery compartment, there are no user-serviceable parts inside.



Serviced by Embla and authorized parties only. Warranty void if encasement screws are loosened.



Contact of liquids with the internal parts and connectors of the Embletta MPR and its components should be avoided at all times. The Embletta MPR and its components are not water resistant, drip-proof, or splash-proof; strictly adhere to the cleaning instructions in this manual.



Do not use the Embletta MPR and its components in a magnetic resonance imaging (MRI) environment.



Do not use the Embletta MPR and its components in an explosive environment, that is, in the presence of flammable liquids or gases.



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 MPR 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, because it might cause the pacemaker to switch to interference mode. Prior to using the Embletta MPR with pacemaker patients, the operator should consult the pacemaker’s accompanying documents regarding its certifications and requirements of use, or, if necessary, contact the pacemaker manufacturer.



Electrostatic discharges (ESD) might cause artifacts in the signal from the device. A trained operator should 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 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 MPR and its components comply with the international standard IEC 60601-1-2 for electromagnetic compatibility (EMC) for medical electrical equipment. The standard is designed to provide reasonable protection against harmful interference in a medical installation. However, because of the proliferation of RF 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, might disrupt the performance of the Embletta MPR or its components. For these reasons, special precaution regarding EMC is needed when the device is installed and put into service.



Use of cables or accessories other than those specified, may result in increased emissions or decreased immunity of the equipment and may result in non-compliance of the system with the requirements of IEC 60601-1-2:2007.

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Warnings, Cautions, and Contraindications 

Before starting data acquisition with the Embletta MPR, always ensure the correct recording profile and patient information (if available) applies to the desired study type.



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



Always inspect the equipment, particularly the cables and connectors, for evidence of wear before each recording. If evidence of wear is found, remove the worn equipment from use, and contact Embla Technical Support ([email protected]) for replacement or servicing.

Intended Use The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient 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 MPR is intended to be used for adult and pediatric studies. The device is not equipped with alarms and is not intended to be used as a monitor. The intended environments include any clean, dry, dust free environment suitable for a patient’s relative comfort.

Safety and Regulatory Information Before using the Embletta MPR, please read this manual carefully, paying particular attention to the caution or warning that appears with each safety symbol. Examples display below. A CAUTION denotes a potential hazard. It calls attention to an operating procedure or practice that could damage the product or loss of important data if it is not properly performed. Do not proceed beyond a CAUTION notice until the indicated conditions are fully understood and met.

A WARNING denotes a hazard. It calls attention to a procedure or practice that could result in personal injury if it is not correctly performed. Do not proceed beyond a WARNING notice until the indicated conditions are fully understood and met.

Essential Performance The Embletta MPR System has no identified essential performance as defined by the applicable safety standards.

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System Components

System Components Embletta MPR System The Embletta MPR recorder is designed to connect to a PC with the USB cable to setup an ambulatory recording. Once the unit is configured, the USB cable is disconnected and batteries are inserted; it is ready for patient studies. Please refer to the software specific documentation for details on preparing the recorder. Component

Name

Embletta MPR Recorder

Battery Door Opener

Embletta MPR Oximeter

Embletta MPR Holster

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System Components Component

Name

Elastic Strap

USB Setup and Download Cable

EEG Electrodes. Reusable EEG electrodes with cable. 100 cm (39 in, 10mm Gold cup). Other quality electrodes meeting these specifications can be used with the Embletta MPR.

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System Components

Embletta MPR PG System The Embletta MPR PG unit is designed to connect with the PC through either a direct USB connection or a wireless connection to the TX Proxy Unit as a transmitter to the PC. The wireless protocol is Bluetooth LE with a transmission range of up to 10 ft./3m. The TX Proxy Unit should be in the same room as the Embletta MPR PG recorder. The wireless communication is used for the transmission of real time signal data for online and ambulatory recording. Please refer to the software specific documentation for details about preparing the recorder. Note: Data transmitted wirelessly has a reduced signal quality. Some local guidelines may not be fulfilled with this type of transmission. The specified signal quality is available when the recording file is downloaded to the host PC. Please refer to the software application documentation for details.

Component

Name

Embletta MPR PG Recorder

Battery Door Opener

Embletta MPR Oximeter

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System Components Component

Name

Embletta MPR Holster

Elastic Strap

USB Setup and Download Cable

EEG Electrodes. Reusable EEG electrodes with cable. 100 cm (39 in, 10mm Gold cup). Other quality electrodes meeting these specifications can be used with the Embletta MPR.

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System Components

TX Proxy Unit The TX Proxy Unit is designed to communicate via an Ethernet connection or a USB connection to a PC. In addition to the communication to the PC, the TX Proxy Unit signal data is transferred to and stored with the Embletta MPR PG signals on the internal memory of the Embletta MPR PG unit. In this way, the study download from the MPR PG includes all system study data. The TX Proxy Unit is powered with an external mains connected power supply, which allows exchanging the adaptation to the regional mains outlet types in the US, UK and EU. CAUTION: Power Supply Do not use a different power supply than the one supplied with and designed for the TX Proxy Unit.

Component

Name

TX Proxy Unit

Power Supply for TX Proxy Unit with regional adapters

Ethernet Cable

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System Components

ST Proxy The ST Proxy is designed to connect to the MPR PG unit to provide a minimal “sleep time” configuration. The ST Proxy has connections for two EEG and two EOG channels referenced to a patient mastoid, one EMG Chin bipolar channel, two EMG Leg bipolar channels and one ECG bipolar channel. The ST Proxy is powered by a connection to the Embletta MPR PG Unit. Component

Name

ST Proxy

ST/ST+ Proxy Interface Cable

EEG Electrodes. Reusable EEG electrodes with cable. 100 cm (39 in, 10mm Gold cup). Other quality electrodes meeting these specifications can be used with the Embletta MPR.

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System Components

ST+ Proxy The ST+ Proxy is designed to connect to the MPR PG unit to provide a fully AASM compliant recording configuration. The ST+ Proxy has connections for six EEG, 2 Mastoids and two EOG channels referenced to a common reference point. It also has connections for a “tri-polar” Chin EMG channel, two EMG Leg bipolar channels and one ECG bipolar channel. The ST+ Proxy is powered by a connection to the Embletta MPR PG Unit. Component

Name

ST+ Proxy

ST/ST+ Proxy Interface Cable

EEG Electrodes. Reusable EEG electrodes with cable. 100 cm (39 in, 10mm Gold cup). Other quality electrodes meeting these specifications can be used with the Embletta MPR.

Embletta MPR Sensors The Embletta MPR System can be purchased with additional sensors, electrodes and accessories depending on your system configuration. Please refer to the appropriate manuals how to setup, use and clean these accessories.

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System Components

Embletta MPR and MPR PG Data Connectors, Display and Buttons Embletta MPR and MPR PG Front Display and Buttons

By default, the display of the Embletta MPR/MPR PG unit is powered off. Pressing any button will activate the display and show information about the status of the device. The Menu and Page buttons allow for scrolling through the functionality pages of the Embletta MPR/MPR PG Unit. The event button lets you enter patient events and confirm data input. Twenty seconds after the last button is pressed, the display goes into sleep mode. See Embletta MPR menu functions for additional information.

Embletta MPR Rear Label

The direct USB connection is located below the battery door. The label on the back of the unit explains how to access the USB connection on the device. See Inserting Batteries in the Embletta MPR / MPR PG for details on opening the battery door. Warning: USB connection to a PC DO NOT REMOVE the battery door to connect the device to a USB port of a computer while the device is connected to a patient.

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System Components

Embletta MPR USB connection

In order to download the data from the device via the USB cable, you must remove the battery door and connect the Mini USB cable provided inside the battery compartment of the device.

TX Proxy Unit Connections

1

Connects to the TX Proxy Unit mains power supply. Labeled with FW7660M/05.

2

Indicates that the device is connected to the mains power supply. Labeled PWR.

3

Indicates that the wireless transmission is active. Labeled with

4

Can be used to connect the TX Proxy Unit directly to a PC and/or Laptop. Labeled with USB and

5

Can be used to connect the TX Proxy Unit to a system network. Labeled with LAN.

6

Can be used to connect serial data input such as data generated from a therapy device (currently limited to ResMed therapy devices). Labeled with RS232 – CPAP.

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. .

System Components

ST/ST+ Proxy Connections

1

Connects to the Embletta MPR PG using the ST/ST+ Proxy Interface Cable. Labeled on the front of the ST or ST+ Proxy.

Sensor Connectors CAUTION: Connections Always inspect the equipment, particularly the cables and connectors, for evidence of wear before each recording. If evidence of wear is found, remove the worn equipment from use, and contact Embla Technical Support ([email protected]) for replacement or servicing. Check the signal input and output ranges before connecting third party devices to the system.

Embletta MPR The Embletta MPR can record the following channels:

Input Label

Available Channels

SND

Can be used to connect a microphone (optional) for recording audible tones.

SpO2

Can be used to connect the Oximeter for recording the oxygen saturation (averaged and beat-to-beat), pulse rate, plethysmographic waveform and various signals to verify the signal quality.

PFlow

Can be used to connect either a nasal cannula for diagnostic recordings or a pressure tube for therapeutic recordings. Various signal traces are derived from the pressure channel such as Airflow, Snoring and Static Pressure data.

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System Components

Embletta MPR PG In addition to the sensor connectors for the Embletta MPR recorder, the Embletta MPR PG recorder can record the following channels:

Input label

Available channels

ExG / PNG / REF

Can be used to connect skin surface electrodes to record ECG, EEG or EMG signals.

NAF

Can be used to connect a thermal sensor to record Airflow signals.

THO

Can be used to connect Embla’s XactTrace respiratory inductance belt to record thoracic movement signals.

ABD

Can be used to connect Embla’s XactTrace respiratory inductance belt to record abdominal movement signals.

DC

Can be used to connect external medical devices which provide data as a 0 – 1 V DC signal. Please refer to the manual of the third party device about the signal specifications and use the appropriate connection cable provided by Embla (isolated or non-isolated).

ST/ST+

Can be used to connect an ST Proxy or an ST+ Proxy via the ST/ST+ Proxy Interface Cable.

Warning: Connection to a third party DC signal DO NOT CONNECT an external device via a non-isolated cable connection to the DC connector of the Embletta MPR PG recorder. Contact Embla Technical Support in case you are uncertain of the isolation specification of your external device.

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System Components

TX Proxy Unit In addition to the sensor connectors for the Embletta MPR PG recorder, the TX Proxy Unit can record the following channels:

Input label

Available channels

PDiff

Can be used to connect the double tube from the Flow Adapter to record a differential pressure signal.

DC Input 1-6

Can be used to connect DC signals from external devices.

External DC signals can be connected to the DC input using a 2.5mm mono jack plug (TS connector). The signal must be connected to the tip of the plug; the signal ground must be connected to the sleeve of the plug. The voltage range allows interfacing signals from -5V to +5V.

ST Proxy Sensor connectors In addition to the sensor connectors for the Embletta MPR PG recorder, the ST Proxy can record the following channels:

Input label

Available channels

PGND/ECG+/ECG-

Can be used to connect skin surface electrodes to record ECG signal.

M2(REF)

Can be used to connect skin surface electrode for patient Reference.

C3/C4

Can be used to connect skin surface electrodes to record EEG signals.

EOG1/EOG2

Can be used to connect skin surface electrodes to record EOG signals.

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System Components Input label

Available channels

Chin+/Chin-

Can be used to connect skin surface electrodes to record bipolar EMG (Chin) signal.

MPR PG

Connects to the MPR PG unit via the ST/ST+ Proxy Interface Cable.

LegR+/LegR-

Can be used to connect skin surface electrodes to record Right Leg bipolar signal.

LegL+/LegL-

Can be used to connect skin surface electrodes to record Left Leg bipolar signal.

ST+ Proxy Sensor Connectors In addition to the sensor connectors for the Embletta MPR PG recorder, the ST+ Proxy can record the following channels:

Input label

Available channels

PGND/ECG+/ECG-

Can be used to connect skin surface electrodes to record ECG signal.

REF

Can be used to connect skin surface electrode for patient Reference.

M1/M2

Can be used to connect skin surface electrode for Mastoid signals.

F3/F4/C3/C4/O1/O2

Can be used to connect skin surface electrodes to record EEG signals.

EOG1/EOG2

Can be used to connect skin surface electrodes to record EOG signals

ChinL/ChinC/ChinR

Can be used to connect skin surface electrodes to record EMG (Chin) signals.

MPR PG

Connects to the MPR PG unit via the ST/ST+ Proxy Interface Cable.

LegR+/LegR-

Can be used to connect skin surface electrodes to record Right Leg bipolar signal.

LegL+/LegL-

Can be used to connect skin surface electrodes to record Left Leg bipolar signal.

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