Nox Medical NOX T3 Installation instructions

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Us se er r I In ns st tr ru uc ct ti io on n
N NO OX X T T3 3

Nox T3 - User Instruction
Version 0.102
Latest Revision 21 April 200
Copyright© 200
Nox Medical - All rights reserved
Nox Medical ehf
Keldnaholti
IS - 112 Reykjavík
Iceland
Phone: +354 - 5229000
Fax: +354 - 5229111
Website: www.noxmedical.com
Email: [e-mail]
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. ll clinical
conclusions and decisions that are based on the use of this product are the responsibility of the user.
Warranty
Nox Medical warrants the products to be free of defects in materials and workmanship for a certain
period of time from the date purchased. The sole liability of Nox Medical is limited to replacement or
repair of the product at the option of Nox Medical if any part is proven to be defective in workmanship,
performance, or materials during the warranty period. Under no circumstances shall Nox be liable for
any loss of revenues or damage, direct, consequential, or incidental, including loss of profit, property
damage, or personal injury arising from the use of, or the inability to use this product. This warranty is
intended for the original buyer and is in lieu of all other warranties or previous agreements, expressed or
implied. This warranty is rendered void if the product is used for other than its intended purpose or is
subject to abuse, misuse, tampering, neglect or unauthorized modifications.

Contents
Contents .................................................................................................................................................................... 3
Introduction ................................................................................................................................................................ 4
Regulatory Information .............................................................................................................................................. 5
Intended Use ......................................................................................................................................................... 5
Warnings and Cautions for Use ............................................................................................................................ 5
Guide to Symbols .................................................................................................................................................. 5
System Components ................................................................................................................................................... 7
he Nox 3 Device ............................................................................................................................................... 7
Interfaces ......................................................................................................................................................... 7
Starting/Stopping a Recording ......................................................................................................................... 8
Navigating the Nox 3 device ......................................................................................................................... 8
Power ............................................................................................................................................................... 9
he Nox 3 Application Software – Noxturnal .................................................................................................. 10
Respiratory Effort Sensor (Belt).......................................................................................................................... 10
Abdomen – horax Cable .................................................................................................................................... 10
USB Cable .......................................................................................................................................................... 11
Nasal Cannula ..................................................................................................................................................... 11
Clip Strap ............................................................................................................................................................ 11
Carry Bag ............................................................................................................................................................ 11
Pulse Oximeter .................................................................................................................................................... 12
Inserting Batteries .......................................................................................................................................... 12
Oximeter Sensors ........................................................................................................................................... 12
ExG Sensors ........................................................................................................................................................ 13
Nox Noxturnal .......................................................................................................................................................... 14
System Requirements .......................................................................................................................................... 14
Desktop Minimum System Requirements ...................................................................................................... 14
Laptop Minimum System Requirements........................................................................................................ 14
Desktop Recommended System Requirements .............................................................................................. 14
Laptop Recommended System Requirements ................................................................................................ 14
Installation........................................................................................................................................................... 15
Running the software .......................................................................................................................................... 18
Configuring the Device .................................................................................................................................. 19
Viewing Recorded Data ................................................................................................................................. 21
Hook-Up ................................................................................................................................................................... 23
Attaching the Device and the Respiratory Effort Sensors ................................................................................... 23
Recording of Respiratory Sounds and Snoring ................................................................................................... 25
Applying the Nasal Cannula ............................................................................................................................... 25
Attaching Electrodes ........................................................................................................................................... 25
Pulse Oximeter Module....................................................................................................................................... 26
Choosing the Appropriate Pulse Oximerer Sensor ......................................................................................... 26
Attaching the Pulse Oximeter Module and Sensor......................................................................................... 26
Precautions for Use of the Pulse Oximeter .................................................................................................... 27
System Maintenance................................................................................................................................................. 28
Calibration........................................................................................................................................................... 28
Cleaning .............................................................................................................................................................. 28
Disposal .............................................................................................................................................................. 28
Specification ............................................................................................................................................................. 29
Nox 3 Device .................................................................................................................................................... 29
Respiratory Effort Sensor .................................................................................................................................... 29
Nasal Cannula ..................................................................................................................................................... 30
Pulse Oximeter Module....................................................................................................................................... 30
Classifications ..................................................................................................................................................... 31
Certifications ....................................................................................................................................................... 31
EMC – Information ............................................................................................................................................. 32
Declaration of Conformity with USA Federal Communications Commission (FCC) and Canadian Ministry
of Health Rules for Electromagnetic Compatibility ....................................................................................... 32
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ..................................................... 34
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ...................................................... 34
Recommended Separation Distance between Portable and Mobile RF Communications Equipment and the
Nox 3 Device ............................................................................................................................................... 35

Introduction ● 4
Introduction
he Nox 3 system consist of a compact digital recorder that is worn by the patient, along with two
respiratory effort sensors, carry bag, clip straps, USB cable and the Nox 3 application (Noxturnal)
used for analyzing and reviewing of data. he device is able of recording signals from two respiratory
effort sensors, respiratory sound/snoring, nasal/mask pressure, pulse oximeter data, position/activity
data, and two channels of EEG/EOG/EMG/ECG leads.

Regulatory Information ● 5
Regulatory Information
Intended Use
he Nox 3 device is intended for ambulatory recording of physiological signals during sleep. he
recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of
the Nox 3 application.
he Nox 3 system can be used with both children and adults.
he Nox 3 system is NOT intended for any patient monitoring or automatic diagnosis.
he intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test
environments, including patient’s home.
!
► Please read this manual carefully before use, especially sections marked with an
exclamation mark.
Warnings and Cautions for Use
► he device is NOT CERTIFIED TO BE USED FOR CONTINUOUS MONITORING where
failure to operate can cause injuries or death of the patient. he term CONTINUOUS
MONITORING is specified in the standard IEC60601-1.
► his system is intended only as an adjunct in patient assessment. It must be used in conjunction
with other methods of assessing clinical signs and symptoms.
► Caution: U.S. Federal law restricts this device to sale by, or on the order of, a physician.
► his system complies with international standards IEC60601-1-2 for electromagnetic compatibility
for medical electrical equipment and/or systems. his 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 device’s performance. 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.
► he device is classified as ordinary equipment regarding ingress of liquids, that is, it is not drip-
proof, splash-proof or watertight. During use of the device avoid all unnecessary contact with
moisture.
► he device is not defibrillator proof.
► Do not use any part of the system in an MRI (Magnetic Resonance Imaging) environment.
► he device and its accessories should be removed from the patient before download of data.
► No user serviceable parts inside the device. Serviced by authorized parties only. Warranty void if
opened.
Guide to Symbols
► Consult instructions for use.
►Caution, consult accompanying documents.
► Manufacturer.

Regulatory Information ● 6
► Do not reuse
► Serial number.
► Batch code.
► ype BF applied part (patient isolation from electrical shock).
► In compliance with the European Directive on Waste of Electrical and Electronic
Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted
municipal waste.
► Non ionizing electromagnetic radiation. Equipment includes RF transmitter:
interference may occur in the vicinity of equipment marked with this symbol.
► CE marking indicating conformance to EC directive No. 93/42/EEC concerning
medical device
FCC ID:
V5ANOX-T3-
0100
► FCC ID label.
Contains TX
IC: 15 0A-
LMX9838
► Industry Canada (IC) label.
►Bluetooth® wireless technology
Bluetooth® Wireless Technology
he Nox 3 uses Bluetooth® wireless technology to receive signals from the Nonin Pulse Oximeter.
he Bluetooth® wireless technology is based on a radio link that offers fast and reliable transmission
of data. Bluetooth® radio uses globally available frequency range in the ISM band, intended to ensure
communication compatibility worldwide and a fast acknowledgement and frequency-hopping scheme
to make the link robust, even in noisy radio environments. Please refer to the Specification section for
details on RF specifications for Nox 3 and Nonin Pulse Oximeter.

System Components ● 7
System Components
The Nox T3 evice
he Nox 3 device records signals from five external sensors and three built-in sensors. he external
sensors that can be used with the device are abdominal and thoracic respiratory effort sensors,
oximeter, and two leads of the following: ECG, EMG, EEG or EOG. he built-in sensors include a
pressure transducer allowing either recording of nasal pressure or mask pressure, a three dimensional
acceleration sensor for measure of patient’s position and activity, and a microphone for measuring of
snoring and true audio recording capabilities. he arrangement of sensors will be determined by the
type of study being performed. he device is worn on the patient’s chest by snapping it to the thoracic
respiratory sensor and securing its position with the clip straps. he device is powered with one AA
battery. he device has a display for status indication, signal integrity and preliminary results, and
buttons for control and event marking.
Interfaces
he Nox 3 device interface consists of a display, buttons, sensor inputs/connections and a USB
connector. he USB connector is placed under the locked battery lid making it inaccessible and tamper
prove for children, and connects to the USB cable for device configuration and data download. See the
figures and tables below for detailed description.
Number Function
1 Display
2 Push button – Select – used to start/stop recording and select display options
3 Push button – Forward button - navigate to the next page
4 Push button – Backward button - navigate to the previous page
5 Pressure lock - Connects to external nasal cannula
6 Bipolar touch proof input - Channel 1
7 Bipolar touch proof input - Channel 2
8 Reference ground input for bipolar channels
9 Microphone - For recording of respiratory sounds and snoring
10 Clip strap loops

System Components ●
Number Function
1 Battery lid - Covers the battery and the USB connector
2 Battery compartment pin – Pressed down with a simple tool to open the battery
compartment
3 Metal snaps - Used to connect to thorax respiratory effort sensor
4 Metal snaps - Used to connect to abdomen-thorax cable
Starting/Stopping a Recording
he Select button located on the front panel of the device can be used to manually start and stop a
recording.
To manually start a recording: Hold down the Select button for at least 3 seconds
!
► he configuration of the device must have been set to Manually Start Recording, refer
to section Configuring the Device.
► he device must be disconnected from the PC (have a battery located in its battery
compartment) to be able to start a recording.
To stop the recording: Hold down the Select button for at least 3 seconds
To start the recording again: Hold down the Select button again for at least 3 seconds
Navigating the Nox T3 device
he device has three push buttons (Select, Backward and Forward) located on the front panel that are
used to get information on the recording taking place. Pressing the Forward button will navigate to the
next page and pressing the Backward button will navigate to the previous page.
o navigate the information pages during a recording perform the following steps:
1. Press the Select button to get
information on the duration of the
recording, actual time and battery
status.

System Components ● 9
2. hen press the Forward button to view
the abdomen and thorax respiratory
effort signals being recorded, as well
as getting information of patient’s
position and whether a snoring signal
is being recorded.
3. Press the Forward button again will
show the actual oxygen saturation and
pulse rate of the patient.
Power
he Nox 3 device is powered by one AA battery. he battery lasts for a minimum of 3x 8 hours.
Inserting the Battery:
1. o open the battery compartment press down the battery compartment 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.
Checking the Battery:
he battery status indicator positioned in the upper right hand corner of the device’s display
allows the user to check the battery status during recording.
!
► o avoid risk of leakage, battery should not be stored in the device for a prolonged
period of time.
► Always use fully charged or fresh battery for each sleep study.

System Components ● 10
The Nox T3 Application – Noxturnal
he Nox 3 application (Noxturnal) is used to configure the device for recording, and downloading,
viewing and analyzing of recorded data. Refer to section Nox Noxturnal for detailed description.
Respiratory Effort Sensor (Belt)
he device uses two identical respiratory effort sensors to measure the respiratory effort of the patient.
One belt is placed around the patient’s abdomen and the other around the patient’s thorax. he belts
are made out of knitted elastic with insulated wire conductor and have a plastic glider for adjustment of
belt length. hey are terminated with a metal snap at the ends that allows for the connection to the Nox
3 device.
he belts are available in two versions and are adjustable to fit patient circumference from 40cm up to
205cm (Xin).
!
► he respiratory effort sensors should be worn over night-clothing or a -shirt.
► he respiratory effort sensors are single patient use.
Abdomen –Thorax Cable
he abdomen-thorax cable connects together the abdomen respiratory effort sensor and the device via
metal snaps on each end of the cable. he cable is wrapped up around the abdomen end for adjustment
of length.

System Components ● 11
USB Cable
After the recording the data is downloaded from the device over USB by use of the proprietary USB
cable provided with the system.
Nasal Cannula
he nasal cannula is optional and connects to the pressure lock on the Nox 3 device for measuring of
airflow pressure. he nasal cannula is equipped with hydrophobic anti-microbial filter. he nasal
cannula is available in two versions, adult and pediatric.
!
► he nasal cannula is single patient use.
Clip Strap
he Nox 3 device is equipped with two clip straps, which are fastened to the night-clothing of the
patient to secure the position of the device during night.
Carry Bag
he carry bag is used to store the Nox 3 system and to carry around in.

System Components ● 12
Pulse Oximeter
he Nonin pulse oximeter is an optional sensor which measures SpO2, pulse rate and
plethysmographic data. It is worn on the patient’s wrist and sends data to the Nox 3 device via
Bluetooth® wireless technology. he oximeter is battery powered.
Inserting atteries
he Nonin pulse oximeter requires two AA alkaline batteries.
1. Remove the battery cover of the pulse oximeter to open the battery compartment
2. Place two AA batteries in the compartment aligning the battery poles as illustrated on the
bottom of the battery cover
3. Close the battery compartment. Make sure the cover is securely closed.
Oximeter Sensors
he Nonin oximeter pulse oximetry module supports all Nonin PureLight M pulse oximeter sensors:
Nonin’s Models Soft Sensor - Reusable Preferred Application Site
Model 8000SL/SL-WO (large) Fingers, oe
Model 8000SM/SM-WO (medium) Fingers, oe
Model 8000SS/SS-WO (small) Fingers, oe
Nonin’s Models Finger Clip Sensor - Reusable
Model 8000AA - Adult Index, middle or ring fingers
Model 8000AP - Pediatric Index, middle or ring fingers
Nonin’s Model s Ear Clip Sensor - Reusable
Model 8000Q
Ear lobe
Nonin’s Model s Reflectance Sensor - Reusable
Model 8000R Middle forehead
Nonin’s Models Flex Sensor - Reusable
Model 8000J + 8000JW -Adult Flex Sensor and Wrap
Index, middle or ring fingers
Model 8008J + 8000JFW -Infant Flex Sensor and Wrap
oe, thumb, medial aspect of
hand

System Components ● 13
Nonin’s Model 8000 Reusable Sensors are indicated for spot-checking and/or continuous monitoring of
patients where little sensor motion is expected
ExG Sensors
he Nox 3 device is capable of recording any combination of two bipolar ExG channels, i.e. EMG,
EEG, EOG or ECG. he use of electrodes is optional and they connect to the bipolar touch proof
inputs on the device.

Hook-Up ● 14
Nox Noxturnal
he Noxturnal application interacts with the Nox 3 device. It allows the configuration of the device as
well as navigating, analyzing and archiving recordings from the device.
System Requirements
he following tables show the minimum and recommended hardware requirements needed to operate
the software effectively
Desktop Minimum System Requirements
Recommended
Operating System Windows® Vista (any version)
Windows® XP Home or Professional with Service Pack 2
Windows® Server 2003 with Service Pack 1
Processor X86 based Intel or AMD
Processor Clock Speed 1.7 GHz or faster
Memory 512 MB or more
Free Hard Drive Space 500 MB or more
Graphics Resolution 1024x768 or higher
Laptop Minimum System Requirements
Recommended
Operating System Windows® Vista (any version)
Windows® XP Home or Professional with Service Pack 2
Processor X86 based Intel or AMD
Processor Clock Speed 1.2 GHz or faster
Memory 512 MB or more
Free Hard Drive Space 500 MB or more
Graphics Resolution 1024x768 or higher
Desktop Recommended System Requirements
Recommended
Operating System Windows® Vista (any version)
Windows® XP Home or Professional with Service Pack 2
Windows® Server 2003 with Service Pack 1
Processor X86 based Intel or AMD
Processor Clock Speed 2.0 GHz or faster
Memory 1 GB or more
Free Hard Drive Space 500 MB or more
Graphics Resolution 1280x1024 or higher
Laptop Recommended System Requirements
Recommended
Operating System Windows® Vista (any version)
Windows® XP Home or Professional with Service Pack 2
Processor X86 based Intel or AMD
Processor Clock Speed 1.5 GHz or faster
Memory 512 MB or more
Free Hard Drive Space 500 MB or more
Graphics Resolution 1280x1024 or higher

Hook-Up ● 15
Installation
Administrative privileges are needed to install Noxturnal. o install the application perform the
following steps:
1. Run the setup.exe file on the installation DVD
2. An installation wizard will appear: Press Next
3. Select an installation location and then press Next

Hook-Up ● 16
4. ype in the location for the shortcut for the application and then press Next
5. his page gives the option of creating a desktop and a quick launch icon for the application.
Check the boxes as preferred and then press Next

Hook-Up ● 17
6. his screen gives overview of where the application will be installed and additional items that
the application depends upon (dependencies). Press Install to accept otherwise press Back and
change your settings
7. he application is now being installed on your computer. he progress bar gives an indication
of the progress during installation

Hook-Up ● 1
8. After installation completes, you might be prompted to restart your computer, do so before
running the application. Select your option and then press Finish.
Running the software
When running the software, the first page that appears is the Start Page shown in the picture below.

Hook-Up ● 19
he Start Page has three tabs:
• Recording Library: he Recording Library sheet lists recorded studies and gives access to
each one of those. By left clicking a recording on the Recording Library list, information
pertaining to that study will be shown on the right side of the page. Double clicking on a
recording in the Recording Library opens up that recording and shows it in the Review Study
sheet.
• Configure Device: he Configure Device sheet let’s you configure the device for a new
recording.
• Review Study: he Review Study sheet shows summary statistics for the recorded data and
gives an overview of that recording.
Configuring the Device
o configure the Nox 3 device perform the following steps:
1. Run the Noxturnal application
2. Connect your device to a USB port on your PC using the USB cable delivered with the
system.
3. he software automatically detects the device and switches to the Review Study tab. o
manually scan for an already connected device you can press the Scan for Devices button in
the upper right hand corner of the Start Page.

Hook-Up ● 20
4. Once the device is detected, press the onfigure Device tab and view the following sheet:
5. ype in information about the subject being recorded in the Subject Info section, e.g. name,
age, address, gender, height and weight
6. Configure the conditions for starting the recording in the Recording Time section. he
simplest option is to Manually Start Recording. If you select this option, once disconnected,
the device will start its recording when you hold down its start/stop/select button for at least 3
seconds. See the picture below:
7. o start a recording at a given time and date, select the Start Recording At option, input the
date, number of nights, start time and duration. When selecting more than one consecutive
night of recordings each recording will start at the same time.
8. Select the applicable signals to be recorded in the Device Properties.