nox T 3 s Manual Ver 1.0 Feb 2020

Nox T3s Manual

Nox T3s Manual Version 1.0 Latest Revision: February 2020 Copyright © 2020 Nox Medical – All rights reserved Manufactured by: Nox Medical ehf Katrinartuni 2 IS – 105 Reykjavik Iceland Website: www.noxmedical.com

For distributor information go to:

www.noxmedical.com

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, magnetic, optical, chemical, manual, or otherwise, without the prior written authorization from Nox Medical. Disclaimer This document may contain typographical errors or technical inaccuracies. Nox Medical does not accept any liability for the use or misuse whether direct or indirect of the products, or for damages arising out of the use of or inability to use the products. Users must accept all responsibility for any results obtained by or concluded from data obtained by the products including software from Nox Medical. All clinical conclusions and decisions that are based on the use of this product are the responsibility of the user. License Notice The Nox T3s recorder’s firmware contains BIGDIGITS multiple-precision arithmetic code originally written by David Ireland, copyright © 2001-8 by D.I. Management Services Pty Limited <www.di-mgt.com.au>, and is used with permission.

Nox T3s Manual

Table of Contents Table of Contents ... 3 List of Abbreviations ... 5 Introduction ... 7 Intended Use ... 7 Contraindications... 7 Scope ... 7 Instructions for Operators ... 8 Warnings and Cautions for Use ... 8 Nox T3s Description ... 11 Nox T3s Interface ... 11 Operating Nox T3s ... 13 Connecting Nox T3s to a Computer ... 13 Configuring and Downloading from Nox T3s ... 13 Establishing a Connection between the Nonin 3150 BLE Pulse Oximeter and Nox T3s ... 13 Manually Starting/Stopping the Nox T3s ... 18 Starting Nox T3s at a Scheduled Time ... 19 Nox T3s Status ... 19 Nox T3s Patient Hookup ... 22 Inserting a Battery to the Nox T3s ... 22 Attaching the Nox T3s and the Nox RIP Belts ... 23 Attaching the Nox Nasal Cannula ... 25 Measuring Mask Pressure... 26 Measuring ExG Signals ... 26 Measuring Pulse and Oxygen Saturation using Nonin 3150 BLE Pulse Oximeter ... 27 Inserting Batteries into the Nonin 3150 BLE Pulse Oximeter ... 28 Selecting Oximeter Sensor Size... 29 Attaching the Nonin 3150 BLE Pulse Oximeter and Soft Sensor ... 29

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Nox T3s Manual Maintenance ... 31 Compatible Sensors and Devices ... 34 Specifications ... 38 Nox T3s and Accessories ... 38 Material Information ... 40 Nox T3s Battery Information ... 41 Regulatory Information ... 42 Performance Testing and Validation Summary ... 42 Nox T3s Classifications ... 42 Description of Symbols and Labels ... 43 Bluetooth® Wireless Technology ... 45 Electromagnetic Compatibility (EMC) Information... 45 About ... 50

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Nox T3s Manual

List of Abbreviations ABS

-

Acrylonitrile Butadiene Styrene

BMI

-

Body Mass Index

CISPR

-

Comité International Spécial des Perturbations Radioélectriques (English: International Special Committee on Radio Interference)

CMDR

-

Canada Medical Device Regulations

ECG

-

Electrocardiography

EEG

-

Electroencephalography

EMG

-

Electromyography

EMC

-

Electromagnetic compatibility

EOG

-

Electrooculography

ESD

-

Electrostatic discharges

FCC

-

Federal Communications Commission

FDA

-

Food and Drug Administration

HF

-

High Frequency

IEC

-

International Electrotechnical Commission

ISM

-

Industrial, Scientific and Medical

MDD

-

Medical Device Directive

MRI

-

Magnetic Resonance Imaging

NiMH

-

Nickel-metal hydride battery rechargeable

PAP

-

Positive Airway Pressure

PC

-

Polycarbonate

PET

-

Polyethylene Terephthalate

PE

-

Polyethylene

PVC

-

Polyvinyl Chloride

RED

-

Radio Equipment Directive

RF

-

Radio Frequency

RIP

-

Respiratory Inductance Plethysmography

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Nox T3s Manual

SpO2

-

Oxygen Saturation Levels measured by pulse oximetry

TPE

-

Thermoplastic Elastomer

WEEE

-

Europe on Waste of Electrical and Electronic Equipment

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Nox T3s Manual

Introduction Congratulations on choosing the Nox T3s™ recorder. The Nox T3s is an ambulatory body worn sleep recorder and is a part of the Nox T3s system. Its main function is to record physiological signals during sleep by use of built-in sensors and patient applied sensors. The Nox T3s recorder has a built-in Bluetooth® module also allowing it to record signals from compatible auxiliary devices. Placement of the recorder and connecting sensors is simple and makes the setup quick and easy. The Nox T3s recorder is configured by the Noxturnal software from Nox Medical, running on a PC that also allows for the review, organization, analyzing, and summarizing of all signals recorded by the device. The complexity of the study is defined by varying the number and types of physiological signals measured.

Intended Use The Nox T3s recorder is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3s application (Noxturnal). The Nox T3s recorder is intended for patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient’s home.

Contraindications The Nox T3s recorder is NOT intended for any patient monitoring or automatic diagnosis.

Scope This manual covers the use of the Nox T3s recorder and its components along with external sensors and auxiliary devices that have been validated with the Nox T3s system. The Nox T3s Recorder is a new variant of the Nox T3 Recorder. The use of the Nox T3 Recorder and its components along with external sensors and auxiliary devices that have been validated with the Nox T3 System is covered in: •

Nox T3 Manual

The picture below shows the different appearance of the Nox T3 Recorder and the Nox T3s Recorder. Please be sure you are following the correct manual for your recorder.

Nox T3 Recorder

Nox T3s Recorder

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Nox T3s Manual The use of the Noxturnal software application that is needed for device configuration, data download, review, and analysis is covered in: •

Noxturnal Manual

This manual is only intended for professionals (healthcare professionals and service personnel) with relevant qualifications and skills. Hookup instructions are available on the Nox Medical Support Site for self-application by the patient.  Note: Additional material can be found on the Nox Medical Website, www.noxmedical.com

Instructions for Operators Operators should contact Nox Medical or its sales representatives •

•

for assistance, if needed, in setting up, attaching, operating or maintaining the Nox T3s system, its accessories, and as applicable external sensors and auxiliary devices that have been validated with the system; or to report unexpected operation or events.

Support information and information about Nox Medical’s sales representatives can be found on Nox Medical’s website: www.noxmedical.com/distributors.

Warnings and Cautions for Use  Warning: The Nox T3s System is NOT certified to be used for continuous monitoring where failure to operate can cause injuries or death of the patient.  Caution: U.S. federal law restricts this device to sale by, or on the order of, a licensed medical practitioner.  Caution: The Nox T3s recorder complies with the international standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. That standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of interference due to close proximity or strength of source might disrupt the performance of the device, affecting recorded signals and therefore data analysis and resulting in possible incorrect treatment. Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC), and needs to be installed and put into service according to the EMC information detailed in the section “Electromagnetic Compatibility (EMC) Information” of this manual.  Warning: The use of accessories, transducers, sensors, and cables other than those listed in this manual may result in increased emissions and/or decreased immunity of the Nox T3s System and cause injuries to the operator/patient.  Warning: The Nox T3s recorder(s) should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device(s) should be observed to verify normal operation in the configuration in which it will be used and prevent abnormal operation which might cause injuries to the operator/patient.

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Nox T3s Manual  Warning: The Nox T3s System may be interfered with by other equipment, even if that equipment complies with International Special Committee on Radio Interference (CISPR) emission requirements, causing possible patient harm.  Caution: Exposure to radio frequency radiation.  Warning: External equipment and all auxiliary devices intended for connection to signal input, signal output or other connectors shall comply with the relevant product safety standards, e.g. IEC 60950-1 for IT equipment and the IEC 60601 series for medical electrical equipment, to prevent electric shocks. In addition, all such combinations – systems – shall comply with the safety requirements stated in the collateral standard IEC 60601-1-1 or the general standard IEC 60601-1, edition 3/3.1, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment, i.e. at least 1.5 m from the patient support. Any person who connects external equipment to the signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements. If in doubt, contact a qualified medical technician or your local representative.  Caution: The Nox T3s recorder is designed to be safe for use for pacemaker patients if the pacemakers comply with the standard: EN 45502-2-1 Active implantable medical devices. Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers). Using non-compliant pacemakers may result in the operation of the pacemaker being affected by the use of Nox T3s recorder and lead to possible patient harm. Prior to using the device with pacemaker patients, the operator should consult the accompanying documents of the pacemaker regarding its certifications and requirements of use or, if necessary, contact the producer.  Warning: Do not use the Nox T3s recorder and accessories during radiography/X-ray studies. The energy absorption in the device, cables or electrodes might lead to excessive heating and cause burns.  Warning: The Nox T3s recorder and accessories are not intended to be used with high frequency (HF) equipment. Using the device with high frequency (HF) equipment could cause potential serious harm to the patient.  Warning: The Nox T3s recorder is not defibrillator proof. Not removing the device from a patient before defibrillation may lead to the creation of high current density at the electrode sites, causing burns and leading to possible patient harm. Not removing the device from a patient before defibrillation may also alter the intended flow of the current, affecting the defibrillation efficiency and causing injuries or death of the patient.  Warning: Do not use any part of the Nox T3s System, including patient cables and electrodes, in a Magnetic Resonance Imaging (MRI) environment. The energy absorption in conductive materials might lead to excessive heating and cause burns.  Caution: The Nox T3s recorder and Nox RIP belts should be worn over clothing to prevent allergic reaction to the equipment materials.  Warning: Avoid accidental contact between connected but unused patient applied parts and other conductive parts including those connected to protective earth to prevent potential serious harm to the operator/patient.  Warning: Do not use damaged equipment, sensors or accessories. This may result in bad performance of the Nox T3s System or patient/operator injury.  Warning: The Nox T3s recorder and its accessories should be removed from the patient before use of the USB connector to prevent electric shock. The USB connector shall only be used for the purposes of configuring the device and downloading data from the device.

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Nox T3s Manual  Warning: There are no user serviceable parts inside the Nox T3s recorder. The device should be serviced by authorized parties only. Service performed by non-authorized parties may affect data analysis and result in possible incorrect treatment. The warranty is void if the Nox T3s recorder is opened (except for opening of the battery compartment).  Warning: No modification of the Nox T3s recorder and its accessories is allowed. Un-authorized modifications could result in the device not performing as intended and cause serious harm to the patient. To ensure patient safety and effective use of the Nox T3s System, only use accessories that have been validated for use by Nox Medical. Refer to section “Compatible Sensors and Devices”.  Warning: Remove batteries from the Nox T3s recorder if it is not used within 30 days to prevent damage from possible battery leakage and prevent possible minor burns to the operator/patient.  Warning: Do not autoclave or immerse the Nox T3s recorder and accessories in any kind of liquids. Ingress of liquids may result in electric shock.  Warning: In the United States of America, only use United States Environmental Protection Agency (EPA) registered products for cleaning of the Nox T3s recorder and accessories to prevent harm to the operator/patient.  Warning: The Nox T3s recorder is NOT suitable for use in presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. That could lead to the creation of electrostatic charges or temperature exceeding limits resulting in sparks or ignition, causing burns or explosions.  Warning: As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation.  Caution: The Nox RIP belts should fit the patient snugly without being uncomfortably tight to avoid discomfort.  Warning: The Nox disposable RIP belts, Nox nasal cannulas, Nox filter tube connectors, mask pressure tubes and Nonin Wristband are single patient use. Using the same Nox disposable RIP belts, cannula, filter tube connector, mask tubing and wristband on more than one patient poses a risk of cross-infection.  Warning: The disposable RIP belts are single use. Reusing the belts may affect the quality of recorded signals and lead to possible incorrect treatment.  Warning: Electrodes should only be used by or in consultation with a healthcare provider familiar with their proper placement and use. Not using and placing the electrodes correctly may affect recording of data, and therefore interpretation and diagnostics.  Warning: The electrodes should be applied only to intact, clean skin (e.g. not over open wounds, lesions, infected or inflamed areas) to prevent infections.  Warning: To prevent cross-contamination, make sure the Soft SpO2 sensor is properly cleaned after turning on the Nonin 3150 BLE pulse oximeter by inserting a finger (other than the patient’s) in the sensor. Refer to 3rd party instructions for use accompanying the pulse oximeter for cleaning instructions.  Caution: The Nox T3s recorder and its accessories should always be transported in its accompanying carrying case to ensure adequate protection and prevent damage.  Please read this manual carefully before use, especially sections marked with an exclamation mark.

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Nox T3s Manual

Nox T3s Description The Nox T3s is a body worn ambulatory sleep recorder. The input channels and built-in capabilities of the device include the following: • • • • • • • •

2 bipolar channels; for recording of electrocardiography (ECG), electromyography (EMG), electroencephalography (EEG) or electrooculography (EOG) 1 ground channel 1 pressure/cannula channel; for recording of nasal or mask pressure 2 respiratory effort channels; for recording of abdomen and thorax ventilatory effort signals 3-D built-in acceleration sensor; for recording of patient’s position and activity Built-in microphone; for recording of audio and snoring Built-in Bluetooth® module; to support wireless connectivity allowing the device to record signals from compatible auxiliary devices Built-in light sensor; for recording of ambient light

The Nox T3s recorder is powered with one AA battery.

Nox T3s Interface The Nox T3s recorder interface consists of a display, buttons, sensor inputs/connections and a USB connector. The USB connector is placed under the battery lid and connects to a USB Type-C cable for device configuration and data download. See the figures and tables below for detailed description.

NUMBER

FUNCTION

1

Display

2

Battery lid – Covers the battery and the USB connector

3

Push button

4

Indicator light for device status Light sensor located under the shaded transparent button

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Nox T3s Manual 5

2 Clip strap loops

6

Microphone – For recording of respiratory sounds

7

Pressure lock (labeled with “PRES”) – Connects to external nasal cannula/mask pressure tube

8

Channel 1 & 2 (labeled with “1” and “2”) – Bipolar touch proof inputs

9

Reference ground input for channels 1 and 2 (labeled with “PGND”) – Unipolar touch proof inputs

10

2 Metal snaps – Connect to abdomen cable

11

2 Metal snaps – Connect to thorax RIP belt

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Nox T3s Manual

Operating Nox T3s The Nox T3s recorder is operated with one push button located on the front panel. Pressing the button turns on the display. The display will automatically turn off in 2 minutes.

Connecting Nox T3s to a Computer To connect Nox T3s recorder to a computer you need to access the USB connector on the device. The USB connector is placed under the battery lid making it inaccessible and tamper proof for children. To open the battery lid, press with the Nox battery Lid Key, accompanying the Nox T3s system kit, on the battery lid pin and slide the battery lid down, towards the bottom of the device. The Nox T3s connects to the computer by using USB Type-C cable. The battery does not have to be inserted while the device is connected to the computer.

When the Nox T3s recorder is connected to the computer the device display lights up and displays a message saying the device is connected to the computer.

Configuring and Downloading from Nox T3s To download a recording or configure a Nox T3s recorder you will need to start the Noxturnal software application (version 6.0 or higher) and connect the device to the computer. Please refer to the Noxturnal manual for more information on how to perform those tasks. When you are done working with the device eject the device from the Noxturnal software and unplug the USB Type-C cable. Insert the battery and close the battery compartment by pressing the lid back towards the device without causing any strain, then slide it back into position, towards the top of the device.

Establishing a Connection between the Nonin 3150 BLE Pulse Oximeter and Nox T3s Before you can send out the Nox T3s recorder and accessories for an ambulatory recording, you need to make sure that a connection has been established between the Nox T3s recorder and the oximeter. The pairing of the Nox T3s recorder and the oximeter is done during the configuration of the device in the Noxturnal software. Follow the instructions below in order to establish a successful connection between the Nox T3s recorder and the Nonin 31505 BLE oximeter. Note: The Nox T3s recorder will only connect to Nonin 3150 BLE oximeters and does not support connecting to the Nonin 3150 Classic oximeters. Refer to the Nox Medical support page for further information.

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Nox T3s Manual

Pairing Process Step 1. Inserting Batteries Start by inserting fresh/fully charged batteries in the Nonin 3150 BLE pulse oximeter.

Step 2. Turning on the Nonin 3150 BLE Pulse Oximeter Turn on the Nonin 3150 BLE pulse oximeter by pressing the gray activation button (red circle on the picturee below) on tope of the device and you will see the display turn on.

Step 3. Connect the Nox T3s recorder with a USB cable and follow the configuration in Noxturnal Fill in the BDA number of the pulse oximeter found on the back of the Nonin 3150 BLE oximeter

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Nox T3s Manual Click Pair with Oximeter and the pairing will be performed either result in a successful pairing

Or an unsuccessful paring

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Nox T3s Manual If not successful follow the troubleshooting tip in the software or see the troubleshooting tips below

Step 4. Bluetooth Wake up mode. If the pairing was successful during the configuration step in Noxturnal the Nonin 3150 BLE has been put into Bluetooth Wake up Mode. That is indicated by the Bluetooth symbol blinking on regular time interval of the study.

The Nonin 3150 BLE will then turn on when the Nox T3s recorder starts a study (either manual start or scheduled start) Now the Nox T3s is ready to be packed and handed over/shipped to customer

Troubleshooting Tips Troubleshooting during oximeter pairing in Noxturnal Incorrect BDA number: If failing, check the BDA number of the device and make sure it matches the number on the Nonin 3150 BLE oximeter.

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Nox T3s Manual

Correct BDA number but devices not pairing a)

Restart the oximeter by removing the batteries and inserting batteries again to the oximeter. Then hold the grey activation button on to turn on the device. Resume the pairing process from Step 3 above. b) Restart the Nox T3s by unplugging the Nox T3s from the computer and plugging it back in again. Resume the pairing process from Step 3 above. Note: This pairing only works for Nonin 3150 BLE oximeters and is not supported with Nonin 3150 Classic oximeters. Refer to the Nox Medical support page for further information. Note: If this happens repeatedly, it might be necessary to send the oximeter in for service.

Troubleshooting of oximeter connection during hook-up (after successful pairing in Noxturnal) Verify that the BDA number of the oximeter used matches the number used to configure the Nox T3s Recorder. The BDA number used in configuration of the Nox T3s can be found on in the display of the device that shows the status of the oximeter connection. The oximeter BDA number is displayed on the back of the oximeter.

In the case of the number on the device does not match the number of the oximeter it is necessary to re-configure the Nox T3s in Noxturnal and insert there the correct BDA number as in step 3 of the pairing:

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Nox T3s Manual

Correct BDA number but oximeter still marked with “x” on status display:

This means that the Nox T3s recorder and the oximeter are not pairing as expected. To resolve try the following: c)

Restart the oximeter by removing the batteries and inserting batteries again to the oximeter. Then hold the grey activation button to turn on the oximeter.

d) Reboot the Nox T3s recorder by simply waiting for the Nox T3s to turn off (it turns off automatically in 2 minutes after it has been turned on) and then, turn on the Nox T3s again by pushing the button or removing and re-inserting the battery. Note: If this does not solve the issue and this happens repeatedly, it might be necessary to send either T3s or the oximeter in for service.

For further information on troubleshooting refer to the Nox Medical Support Site.

Manually Starting/Stopping the Nox T3s If the Nox T3s recorder has been configured to start the recording manually, you can use the button to manually start a recording. Pressing the button turns on the display. The device will instruct you to “Hold button down to start recording”. Please do so until you see “Recording Duration” displayed. Note the button needs to be pressed down for approximately 4-5 s before “Recording Duration” displays. At this point the device has started to record data and the REC symbol appears at the top of the screen. After the display turns off, the light under the button will blink green intermittently indicating that a recording is taking place. Use the same method to manually stop the recording.

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Nox T3s Manual

If the duration of the recording has been specified during configuration, the recording will automatically stop after the specified duration.

Starting Nox T3s at a Scheduled Time If the Nox T3s recorder has been configured to automatically start a recording at a scheduled time, there are no actions required for the recording to start. Pressing the button before the recording has started will display a countdown to the specified start time of the recording. If the recording has begun, the display shows the current duration of the recording and the REC symbol appears on the top of the screen.

Nox T3s Status Indicator Light The indicator light on the Nox T3s recorder blinks green when a recording is in progress and the device is functioning normally. When there are any device warnings the indicator light blinks amber. Warnings might include: •

Battery low

•

Device not licensed.

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Nox T3s Manual

Displays Information about the recording duration, recording status and device connections is shown on the display. If the display is turned off, pressing the button turns it on. By pressing the button again, you will loop through the available displays. The display will turn itself off again after being inactive for 2 minutes. The display includes information about device connection, time and battery status. 1.

2.

3.

A Bluetooth symbol and an “X” or a checkmark “” are visible on all displays. This symbol shows the status of the Bluetooth connection with the oximeter. An “X” means there is not Bluetooth connection, a “” means there is a Bluetooth connection. The device’s clock. When Nox T3s is configured, the clock is synchronized with the PC and is shown at the top of the display. On the top right corner is a battery indicator which shows the battery status. The battery indicator is full when the device has fresh batteries.

The first display that shows up after the device is turned on shows information about the recording planned or ongoing as explained in previous sections. The second display shows the status of the oximeter connection.

1.

2.

An “X” next to SpO2 indicates that the oximeter is not connected to the device. Once an oximeter has been connected, a checkmark “” will appear. The Bluetooth device address (BDA) of the oximeter that the device is trying to connect to or is connected to.

The third display shows the status of scheduled recordings. It only appears if the device is configured for 2 or 3 scheduled recordings.

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