Nox Medical T3 User manual

Manual
Copyright 2017 Nox Medical

Nox T3 Manual
Nox T3 Manual
Version 2.3
Latest Revision: March 2017
Copyright © 2017
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® 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.

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Table of Contents
Table of Contents .....................................................................................................................................3
List of Abbreviations.................................................................................................................................5
Introduction..............................................................................................................................................7
Intended Use .......................................................................................................................................7
Contraindications.................................................................................................................................7
Scope ...................................................................................................................................................7
Instructions for Operators ...................................................................................................................7
Warnings and Cautions for Use ...........................................................................................................8
Nox T3 Description .................................................................................................................................11
Nox T3 Interface ................................................................................................................................11
Operating Nox T3....................................................................................................................................13
Connecting Nox T3 to a Computer.....................................................................................................13
Configuring and Downloading from Nox T3 ......................................................................................13
Manually Starting/Stopping Nox T3...................................................................................................13
Starting Nox T3 at a Scheduled Time.................................................................................................14
Nox T3 Signal and Status Checks........................................................................................................14
Nox T3 Patient Hookup...........................................................................................................................17
Inserting a Battery to the Nox T3.......................................................................................................18
Attaching the Nox T3 and the Nox RIP Belts......................................................................................18
Attaching the Nox Nasal Cannula ......................................................................................................21
Measuring Mask Pressure..................................................................................................................22
Measuring ExG Signals.......................................................................................................................22
Measuring Data from Auxiliary Devices.............................................................................................22
Measuring Pulse and Oxygen Saturation using Nonin 3150 Pulse Oximeter ....................................23
Inserting Batteries into the Nonin 3150 Pulse Oximeter...................................................................24
Selecting Oximeter Sensor Size..........................................................................................................24
Attaching the Nonin 3150 Pulse Oximeter and Soft Sensor ..............................................................25

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Establish a Connection between the Nonin 3150 Pulse Oximeter and Nox T3 .................................27
Maintenance......................................................................................................................................32
Compatible Sensors and Devices............................................................................................................35
Specifications..........................................................................................................................................39
Nox T3 and Accessories .....................................................................................................................39
Material Information .........................................................................................................................41
Nox T3 Battery Information...............................................................................................................42
Regulatory Information ..........................................................................................................................43
Performance Testing and Validation Summary .................................................................................43
Nox T3 Classifications ........................................................................................................................43
Description of Symbols and Labels ....................................................................................................44
Bluetooth® Wireless Technology.......................................................................................................45
Electromagnetic Compatibility (EMC) Information............................................................................46
About......................................................................................................................................................52

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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
R&TTE
-Radio and Telecommunication Terminal Equipment
RF
-Radio Frequency

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RIP
-Respiratory Inductance Plethysmography
SpO2
-Oxygen Saturation Levels measured by pulse oximetry
TPE
-Thermoplastic Elastomer
WEEE
-Europe on Waste of Electrical and Electronic Equipment

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Introduction
Congratulations on choosing the Nox T3® recorder. The Nox T3 is an ambulatory body worn sleep
recorder and is a part of the Nox T3 System. Its main function is to record physiological signals during
sleep by use of built-in sensors and patient applied sensors. The Nox T3 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 T3
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 T3 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 T3 application (Noxturnal). The Nox T3 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 T3 recorder is NOT intended for any patient monitoring or automatic diagnosis.
Scope
This manual covers 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. 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.
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 T3
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.

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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 T3 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 T3 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 T3 System and
cause injuries to the operator/patient.
Warning: The Nox T3 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.
Warning: The Nox T3 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.
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 T3 recorder does not increase the safety risk for pacemaker patients if the
pacemakers comply with the standard: EN 50061 Safety of Implantable Cardiac Pacemakers. Using
non-compliant pacemakers may result in the operation of the pacemaker being affected by the
use of the Nox T3 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 T3 recorder and accessories during radiography/X-ray studies. The
energy absorption in the device, cables or electrodes might lead to excessive heating and cause

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burns.
Warning: The Nox T3 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 T3 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 T3 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 T3 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 T3 System or patient/operator injury.
Warning: The Nox T3 recorder and its accessories should be removed from the patient before
download of data via 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.
Warning: There are no user serviceable parts inside the Nox T3 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 T3 recorder is
opened (except for opening of the battery compartment).
Warning: No modification of the Nox T3 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 T3 system, only use accessories that
have been validated for use by Nox Medical.
Warning: Remove batteries from the Nox T3 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: The Nox T3 recorder and accessories are not designed to give a specified degree of
protection against harmful ingress of liquids. Do not autoclave or immerse the device 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 T3 recorder and accessories to prevent
harm to the operator/patient.
Warning: The Nox T3 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 and mask
pressure tubes are single patient use. Re-using the Nox disposable RIP belts may affect the quality

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of recorded signals and lead to possible incorrect treatment. Using the same disposable RIP belt,
cannula, filter tube connector and mask pressure tube on more than one patient poses a risk of
cross-infection.
Warning: To prevent cross-contamination, make sure the Soft SpO2 probe is properly cleaned
after turning on the Nonin 3150 Pulse Oximeter by inserting a finger (other than the patient´s) in
the probe. Refer to 3rd party instructions for use accompanying the pulse oximeter for cleaning
instructions.
Caution: The Nox T3 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 T3 Description
The Nox T3 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
The Nox T3 recorder is powered with one AA battery.
Nox T3 Interface
The Nox T3 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 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

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5
Pressure lock –Connects to external nasal cannula/mask pressure tube
6
Channel 1 –Bipolar touch proof inputs
7
Channel 2 –Bipolar touch proof inputs
8
Reference ground input for channels 1 and 2
9
Microphone –For recording of respiratory sounds
10
2 Clip strap loops
11
Indicator light for device status
12
Battery lid –Covers the battery and the USB connector
13
Battery lid pin
14
2 Metal snaps –Connect to thorax RIP belt
15
2 Metal snaps –Connect to abdomen cable
15
Metal snaps –Connect to abdomen cable

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Operating Nox T3
The Nox T3 recorder 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 Nox T3 to a Computer
To connect Nox T3 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 T3 System Kit, on the
battery lid pin and slide the battery lid down, towards the bottom of the device. The Nox T3 connects
to the computer by using Nox mini USB cable. The battery does not have to be inserted while the
device is connected to the computer.
When the Nox T3 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 T3
To download a recording or configure a Nox T3 recorder you will need to start the Noxturnal software
application 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 Nox 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.
Manually Starting/Stopping Nox T3
If the Nox T3 recorder 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 green intermittently indicating
that a recording is taking place. Use the same method to manually stop the recording.

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If the duration of the recording has been specified during configuration, the recording will
automatically stop after the specified duration.
Starting Nox T3 at a Scheduled Time
If the Nox T3 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 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 and the REC symbol
appears on the top left corner.
Nox T3 Signal and Status Checks
Device Status
The indicator light on the Nox T3 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 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 duration and the device is shown on the display. If the display is
turned off, pressing the Middle button turns it on. The display will turn itself off again after being

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inactive for 2 minutes. When Nox T3 is configured the clock is synchronized with the PC and is shown
at the top of the display.
1. 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.
2. On 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.
3. The device’s clock
Signal Status
If the Nox T3 recorder has been configured to “Standard Device Display” in the Noxturnal software,
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 Nox T3
recorder. Note that if the “Minimal Device Display”option has been selected in Noxturnal instead of
the “Standard Device Display”, the device is in simple operation mode and only the start page and the
Bluetooth® connection display screen is available.
Oximeter Signals
Pressing Forward on the display shows the Nonin 3150 Pulse Oximeter connection status. Refer to
section “Establishing a Connection between the Nonin 3150 Pulse Oximeter and Nox T3” for further
information on the Oximeter connection status.
Respiratory Signals
Pressing Forward button on the display again shows information about the respiratory signals:
1. Abdomen and thorax respiratory effort
movements. The signals sweep over
the screen showing the breathing
pattern.
2. Audio, power gauge.
3. Patient position (“Left”, “Right”,
“Supine”, “Prone”and “Upright”).

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ExG and Pressure Signals
To enter the ExG channels, press the Forward button until the ExG channels appear: Channel 1,
Channel 2, and values from the pressure channel. Depending on the configuration either the mask
pressure or nasal pressure is shown. The mask pressure shows the average DC value ranging from 0-
20 cmH20. The nasal pressure shows the pressure values as a signal plot that sweeps over the screen
(no pressure value).
1. Mask pressure DC value.
2. ExG channels. The signals sweep across
the screen showing the raw signals.
1. Nasal pressure signal.
2. ExG channels. The signals sweep across
the screen showing the raw signals.

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Nox T3 Patient Hookup
In most cases the hookup takes place at the patient’s home and the patient hooks up the device by
using the Nox T3 recorder hookup instructions. It is then recommended that a healthcare professional
with relevant qualifications and skills demonstrates the steps needed to be conducted at the patient’s
home to the patient, or to caretakers in the case of pediatric patients. Hookup instructions are
available on the Nox Medical Support Site for self-application by the patient.
The following points should be demonstrated to the patient or caretakers of pediatric patients:
1. Attaching Nox T3 recorder and sensors.
2. Testing of sensors connections.
3. Starting and stopping a recording (if manual recording mode is being used)
4. Status indications on the display.
It is important to remind the patient/caretaker to follow the instructions given, prior to the recording.
Before sending the patient home:
1. Make sure the Nox T3 recorder has been prepared correctly.
2. Make sure the carry case contains all the equipment needed to perform the recording in the
patient’s home, including batteries.
Children should under no circumstances hook up the Nox T3 by themselves.
Warning: Do not use damaged equipment, sensors or accessories. This may
result in bad performance of the Nox T3 System or patient/operator injury.
Warning: As with all medical equipment, carefully route cables and
connections to reduce the possibility of entanglement or strangulation.
Caution: The Nox T3 recorder and its accessories should always be
transported in its accompanying carrying case to ensure adequate protection
and prevent damage.
Warning: No modification of the Nox T3 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 T3 system, only use accessories
that have been validated for use by Nox Medical.
NOTE: The compliance of the Nox T3 System towards patient safety and
medical device standards has ONLY been verified and validated with the
sensors and accessories listed in this manual. This includes all signal
characteristics and automatic analysis provided by the system.


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Inserting a Battery to the Nox T3
Note: Always use fully charged Powerex 2700 mAh Rechargeable Batteries or
fresh lithium battery for each recording to prevent the need for the sleep study to
be repeated.
Note: All lithium batteries used with the Nox T3 recorder shall be per the standard
IEC 60086-4 Primary batteries –Part 4: Safety of lithium batteries.
Before you start a recording, you should make sure that the Nox T3 recorder 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 the Nox Battery Lid
Key accompanying the Nox T3 System Kit 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.
Please refer to the section “Nox T3 Battery Information”regarding the types of batteries
recommended for use with the Nox T3 recorder.
Attaching the Nox T3 and the Nox RIP Belts
Caution: The Nox T3 recorder and Nox disposable RIP belts should be worn over
clothing to prevent allergic reaction to the equipment materials.
The Nox disposable RIP belts should fit the patient snugly without being
uncomfortably tight.
Warning: The Nox disposable RIP belts are single use and single patient use. Re-
using the Nox disposable RIP belts may affect the quality of recorded signals and
lead to possible incorrect treatment. Using the same Nox disposable RIP belt on
more than one patient poses a risk of cross-infection.

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Step 1
Snap the clips that are attached to the Nox T3 recorder to the patient’s shirt.
Step 2 to Step 4
•Snap the Nox abdomen cable to the back of the device.
•Place a Nox disposable RIP belt around the thorax and snap its ends to the back panel of the
device.
•Adjust the Nox abdomen cable length as needed by wrapping it around the abdomen
connection unit. Place a Nox disposable RIP belt around the abdomen and snap it in place.

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Step 5
Attaching the Nox T3 recorder and Nox disposable RIP belts is now completed.
Adjusting the Nox RIP Belts
Caution: The Nox disposable RIP belts should fit the patient snugly without being
uncomfortably tight to avoid discomfort.
Note: For most patients, the Nox 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 Nox
disposable RIP belts packages for more detailed instruction.
Fit the Nox disposable RIP 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.