Nox T 3 Manual Ver 1.4 Feb 2015

Nox T3 Manual Version 1.4 Latest Revision: February 2015 Copyright © 2015 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 T3® device software 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 T3 Manual

Table of Contents Table of Contents ... 3 Introduction ... 5 Scope ... 5 Warnings and Cautions for Use ... 5 Device Description ... 7 Intended Use... 7 Contraindications ... 7 T3 Interface ... 8 Operating the Device ... 9 Connecting the T3 Device to a Computer ... 9 Configuring and Downloading from a T3 Device ... 9 Establishing a Connection between the Nonin 3150 Oximeter and a T3 Device... 9 Manually Starting/Stopping a Recording ... 11 Starting a Recording at a Scheduled Time ... 11 Signal and Status Checks ... 12 Patient Hookup ... 16 Inserting a Battery to the T3 Device ... 17 Attaching the T3 Device and the RIP Belts ... 18 Attaching the Nasal Cannula ... 19 Measuring Mask Pressure... 20 Measuring ExG Signals ... 21 Measuring Capnography ... 21 Measuring Pulse and Oxygen Saturation ... 21 Inserting Batteries into the Oximeter ... 22 Selecting Oximeter Sensor Size... 24 Attaching the Pulse Oximeter Module and Sensor ... 25 Maintenance... 27 Compatible Sensors and Devices ... 29

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Nox T3 Manual Specifications ... 32 T3 Device ... 32 Material Information ... 33 Battery Information ... 34 Regulatory Information ... 35 Performance Testing and Validation Summary ... 35 Classifications ... 35 Description of Symbols ... 35 Bluetooth® Wireless Technology ... 37 EMC Information ... 37

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Nox T3 Manual

Introduction Congratulations on choosing the new Nox T3® portable sleep recorder. The T3 device is designed for recording physiological signals of patients with suspected sleep disorders. The device is compact, lightweight and easy to use. Simple sensor placement and clear instructional diagram makes setup quick and easy.

Scope This manual covers the T3 device and its components along with external sensors and devices that have been validated with the T3 system. It does not cover the software application needed for device configuration, data download, review and/or analysis.

Warnings and Cautions for Use  The device is NOT CERTIFIED TO BE USED FOR CONTINUOUS MONITORING where failure to operate can cause injuries or death of the patient. The term CONTINUOUS MONITORING is specified in the standard IEC 60601-1.  Caution: U.S. Federal law restricts this device to sale by, or on the order of, a physician.  This device complies with the international standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. This 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. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to information detailed in the EMC Information section of this manual.  External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. 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, 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 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 qualified medical technician or your local representative.  The T3 device does not increase the safety risk for pacemaker patients as long as the pacemakers comply with the EN 50061 standard of electrical safety of medical devices. Nevertheless, 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/caution: Do not use the T3 System during radiography/X-ray studies.  The T3 device is not intended to be used with high frequency (HF) equipment  The device is not defibrillator proof.  Do not use any part of the T3 system in an MRI (Magnetic Resonance Imaging) environment.  The T3 device and RIP belts should be worn over clothing.  WARNING: Avoid accidental contact between connected but unused APPLIED PARTS and other

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Nox T3 Manual conductive parts including those connected to protective earth.  Do not use damaged equipment, sensors or accessories.  The T3 device and its accessories should be removed from the patient before download of data.  There are no user serviceable parts inside the T3 device. The T3 device should be serviced by authorized parties only. The warranty is void if the T3 device is opened.  WARNING: No modification of this equipment is allowed.  To avoid risk of battery leakage, the T3 device should not be stored with a battery inserted in the battery compartment.  Please read this manual carefully before use, especially sections marked with an exclamation mark.

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Nox T3 Manual

Device Description The Nox T3 device records signals from three built-in sensors and five external sensors. The built-in sensors include a pressure transducer allowing recording of nasal/mask pressure and snoring, a three dimensional acceleration sensor for measuring patient’s position and activity and a microphone for true audio recording capabilities. The external sensors options are abdominal and thoracic RIP belts and two channels of ExG, i.e., ECG, EMG, EEG or EOG. The T3 device also supports wireless Bluetooth® connectivity allowing it to record signals from a compatible Bluetooth pulse oximeter, and capnography data via the Nox EtCO2 Interface. The device is powered with one AA battery.

Intended Use The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The T3 device 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 T3 device is NOT intended for any patient monitoring or automatic diagnosis.

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Nox T3 Manual

T3 Interface The T3 device 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 mini USB cable for device configuration and data download. The display allows for status indication where signals can be checked in real time. See the figures and tables below for detailed description.

NUMBER

FUNCTION

1

Display

2

Push button – Middle

3

Push button – Forward

4

Push button – Backward

5

Pressure lock – Connects to external nasal cannula/mask pressure tube

6

Bipolar touch proof inputs – Channel 1

7

Bipolar touch proof inputs – Channel 2

8

Reference ground input for channels 1 and 2

9

Microphone – For recording of respiratory sounds

10

Clip strap loops

11

Indicator light for device status

12

Battery lid – Covers the battery and the USB connector

13

Battery lid pin

14

Metal snaps – Connect to thorax RIP belt

15

Metal snaps – Connect to abdomen cable

15

Metal snaps – Connect to abdomen cable

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Nox T3 Manual

Operating the Device The T3 device is operated with three push buttons located on the front panel. Pressing the Middle button turns on the display. The display will automatically turn off in 2 minutes.

Connecting the T3 Device to a Computer To connect a T3 device 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 a pen or a similar tool on the battery lid pin and slide the battery lid down, towards the bottom of the device. The T3 device connects to the computer by using a mini USB cable. The battery does not have to be inserted while the device is connected to the computer.

When the T3 device 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 a T3 Device To download a recording or configure a T3 device you will need to start the applicable T3 software application after connecting the device to the computer. Please refer to the applicable software user manual for more information on how to perform those tasks. When you are done working with the device unplug the mini USB 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 Oximeter and a T3 Device If you are using the Nonin SpO2 Oximeter, Model 3150 please follow the instructions below on how to establish a connection between the oximeter and the T3 device. 1. 2. 3.

4.

Configure the T3 device. Insert fresh/fully charged batteries in the T3 and the 3150 oximeter. Turn on the oximeter’s display by connecting the Flex/Soft Sensor and pressing the oximeter’s activation button for approximately 2 seconds and wait until the oximeter display is lit up Turn on the display of the T3 device by pressing the middle button.

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Nox T3 Manual 5.

To program the oximeter follow the steps below: 1. Wait until the letters “CP” appear on the oximeter’s display. 2. When you have seen the “CP” appear on the display the oximeter has been successfully programmed for the recording. The oximeter may display pulse/saturation information, when the finger is placed in the sensor or if you have scheduled a recording the intended start time for the recording will blink every 30s. 1

2

NOTE: If you are using a Flex Sensor it is strongly recommended to schedule the recording to start at a specific time. NOTE: It is important NOT to remove the oximeter’s batteries after the oximeter has been programmed as this will cause it to lose its configuration and making it necessary to repeat steps 3 – 5.

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Nox T3 Manual

Manually Starting/Stopping a Recording If the device has been configured to start the recording manually, you can use the Middle button to manually start a recording. Pressing the middle button turns on the display. The device will instruct you to “Hold middle button down to start recording”. Please do so until you see “Recording Duration” displayed. Note the Middle 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. After the display turns off, the light on the top right side of the display will blink intermittently indicating that recording is taking place. Use the same method to manually stop the recording.

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

Starting a Recording at a Scheduled Time If the device has been configured to automatically, start a recording at a scheduled time there are no actions required for the recording to start. Pressing the Middle 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.

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Nox T3 Manual

Signal and Status Checks The indicator light on the device blinks green when a recording is in progress and the device is functioning normally. When there are any device warnings the indicator light blinks orange. Warnings might include: 

Battery low



Device not licensed Note the license status is only shown for a short time on the display start page when turning on the device (a lock indicator in the bottom right corner).

Information about the recording and signals status is shown on the device display. If the display is turned off, pressing the Middle button turns it on. The display will turn itself off again after being inactive for 40 seconds.

1.

2.

On the top right corner is a battery bar which shows the battery status. The battery bar is full when the device has fresh batteries. In the bottom left corner is a number indicating how many recordings are stored on the device. The device can contain as many recordings as the internal 1GB memory allows.

Signal Status If the T3 device has been configured to View Signal Status, the signal status can be viewed by browsing through different device pages using the Forward and Backward buttons. The information presented will depend on the configuration of the T3 device. Note that if the View Signal Status option is not checked, the device is in simple operation mode and only the start page will be shown.

Respiratory Signals Pressing Forward on the display shows information about the respiratory signals.

1.

Abdomen and thorax respiratory effort movement. The signals sweep over the screen showing the breathing pattern.

2.

Audio, power gauge.

3.

Patient’s position (Left, Right, Supine, Prone and Upright).

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Nox T3 Manual

Oximeter Signals Pressing the Forward button again will show the patient’s actual oxygen saturation levels (SpO2) and pulse rate in beats per minute (bpm).

If communication has not been established with the selected oximeter, a message is displayed indicating that the device is trying to communicate with an oximeter with a certain serial number.

Make sure that the serial number of the oximeter used matches the configured serial number. Also, be sure that the Bluetooth symbol is displayed on the screen of the oximeter. If the Bluetooth symbol is not displayed, the Bluetooth is inactive and the T3 device cannot connect to the oximeter.

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Nox T3 Manual If the Bluetooth symbol is not visible, press the small button at the top of the oximeter and hold it down for 3 seconds or until the Bluetooth symbol appears on the screen.

If the oximeter probe is not on the finger or the values received from the oximeter are outside normal range, a message comes up on the display saying Probe not on finger.

Capnography Signals When the T3 device has been configured to record capnography data pressing the Forward button one more time will show the capnography display, including CO2 waveform, end-tidal CO2 (EtCO2) value (mmHg) and respiratory rate/respiration per minute (rpm). NOTE: If the T3 device has not succeeded in connecting with the capnography monitor, the display will indicate that it is still trying to connect and will display the serial number of the Nox EtCO2 interface.

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Nox T3 Manual

ExG and Pressure Signals Pressing the Forward button one more time will show the ExG channels: channel 1, channel 2 and the values from the pressure transducer. Depending on the configuration, either the mask pressure or nasal pressure is shown. The mask pressure shows the average DC value in cmH 20 ranging from 0-20 cmH20. The nasal pressure has its DC value removed and shows the pressure values as a signal plot that sweeps over the screen.

1. Mask pressure DC value 2. ExG channels, sweep across the screen showing the raw signals

1. Nasal pressure signal 2. ExG channels, sweep across the screen showing the raw signals

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Nox T3 Manual

Patient Hookup It is highly recommended that a trained clinician demonstrates the use of the T3 device to the patient, or in the case of pediatrics to the parents. In most cases the hookup takes place at home and the patient hooks up the device by using the T3 hookup instructions. The technician should go through the following points with the patient: 1.

Attaching T3 device and sensors.

2.

Testing of sensors connections.

3.

Status indications on the display.

4.

Replacement of battery for multiple night recordings.

It is important to remind the patient to follow the instructions given, prior to the recording. Before sending the patient home: 1.

Make sure the device has been prepared correctly.

2.

Make sure the carry case contains all the equipment needed to finish the recording, including batteries.

 Children should under no circumstances hook up the equipment.  Do not use damaged equipment, sensors or accessories.  As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation.

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Nox T3 Manual

Inserting a Battery to the T3 Device Before you start a recording you should make sure that the device has new or fully charged battery. To insert a new battery do the following:

1.

Open the battery compartment by pressing down the battery lid pin with a pen or similar tool and slide the lid towards the bottom of the device.

2.

Place one AA battery in the compartment aligning the battery poles as illustrated on the back of the device (the positive (+) pole is towards the battery lid).

3.

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. Make sure the lid is securely closed.

The status of the battery can be checked by turning on the device. The battery status indicator positioned in the upper right-hand corner of the device display allows you to check the battery status. When the battery is running low during a recording the device will automatically stop the recording.

When recording multiple nights the patient might be required to change the battery after each night. Please refer to the section Battery Information regarding the types of batteries recommended for use with the T3 device.  Always use fully charged or fresh battery for each sleep recording.  All lithium batteries used with the T3 device shall be according to the standard IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries.

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Nox T3 Manual

Attaching the T3 Device and the RIP Belts Step 1 1.

Snap the clips that are attached to the device to the patient’s shirt. 1

Step 2 to Step 4 2. 3. 4.

Snap the abdomen cable to the back of the device. Place a RIP belt around the thorax and snap its ends to the back panel of the device. Adjust the cable length as needed by wrapping it around the abdomen connection unit. Place a RIP belt around the abdomen and snap in place.

2

3

4

Step 5 5.

Attaching the device and respiratory sensors is now completed. 5

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Nox T3 Manual

Adjusting the RIP Belts Disposable RIP Belts Fit the belts around the patient’s waist and thorax and adjust the length using the loop on each end to adjust the belt length such that the belt covers about two thirds of the patient’s circumference when the belt is unstretched. The length is fixed with hooks on the plastic connector of the belt.

Refer to the section Compatible Sensors and Devices regarding the types of Nox RIP belts that have been validated with the T3 device. NOTE: For most patients the disposable RIP belts do not need to be adjusted if the correct belt size is chosen based on the patient’s abdomen circumference and/or body mass index (BMI). Belt size selection tables accompany the product for more detailed instruction.  The T3 device and RIP belts should be worn over clothing.  The RIP belts should fit the patient snugly without being uncomfortably tight.  The disposable RIP belts are single use.  The use of the same disposable RIP belt on more than one patient poses a risk of cross-infection.

Attaching the Nasal Cannula Step 1 1.

Place the nasal prongs gently in the nostrils. The prongs should point downwards inside the nostrils.

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Nox T3 Manual

1

Step 2 2.

Pull the cannula tubing over the ears and then position it under the chin.

Step 3 3.

Slide the fastener snugly under the chin to hold the cannula tubing securely in place. 1

2

3

NOTE: The Nox nasal cannula with filter has a built-in hydrophobic filter and is the preferred way to measure nasal airflow and snoring as it is designed to maximize the signal quality and fits directly with the T3 device. If it is preferred to use a non-filtered Luer-lock cannula, it is necessary to use a filter tube connector from Nox Medical to interface with the T3 device. Refer to the section Compatible Sensors and Devices regarding the types of nasal cannulas that have been validated with the T3 device.  Medical tape can be used to hold the cannula against the cheeks to secure the cannula in place if necessary.  The nasal cannula is single patient use.  The use of the same nasal cannula on more than one patient poses a risk of crossinfection.

Measuring Mask Pressure A mask pressure tube is used for connection to CPAP masks for measuring mask pressure. The pressure tube connects to the pressure lock on the T3 device via a filter tube connector from Nox Medical.

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