Nox Medical NOX T3 User Instruction
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Nox Medical NOX T3 User Instruction

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Summary of Contents for Nox Medical NOX T3

  • Page 2 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.

  • Page 3: Table Of Contents

    Interfaces ................................. 7 Starting/Stopping a Recording ......................... 8 Navigating the Nox T3 device ......................... 8 Power ................................9 The Nox T3 Application Software – Noxturnal ....................10 Respiratory Effort Sensor (Belt).......................... 10 Abdomen –Thorax Cable ............................ 10 USB Cable ................................11 Nasal Cannula ..............................

  • Page 4: Introduction

    Introduction The Nox T3 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 T3 application (Noxturnal) used for analyzing and reviewing of data. The 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.

  • Page 5: Regulatory Information

    Regulatory Information Intended Use The Nox T3 device 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.
  • Page 6 ►Bluetooth® wireless technology Bluetooth® Wireless Technology The Nox T3 uses Bluetooth® wireless technology to receive signals from the Nonin Pulse Oximeter. The 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.

  • Page 7: System Components

    System Components The Nox T3 Device The Nox T3 device records signals from five external sensors and three built-in sensors. The 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. The 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...

  • Page 8: Starting/Stopping 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 The 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.

  • Page 9: Power

    Power The Nox T3 device is powered by one AA battery. The battery lasts for a minimum of 3x 8 hours. Inserting the Battery: To open the battery compartment press down the battery compartment pin with a pen or...

  • Page 10: The Nox T3 Application Software - Noxturnal

    The Nox T3 Application – Noxturnal The Nox T3 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) The device uses two identical respiratory effort sensors to measure the respiratory effort of the patient.

  • Page 11: Usb Cable

    Nasal Cannula The nasal cannula is optional and connects to the pressure lock on the Nox T3 device for measuring of airflow pressure. The nasal cannula is equipped with hydrophobic anti-microbial filter. The nasal cannula is available in two versions, adult and pediatric.

  • Page 12: Pulse Oximeter

    The 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 T3 device via Bluetooth® wireless technology. The oximeter is battery powered.

  • Page 13: Exg Sensors

    ExG Sensors The Nox T3 device is capable of recording any combination of two bipolar ExG channels, i.e. EMG, EEG, EOG or ECG. The use of electrodes is optional and they connect to the bipolar touch proof inputs on the device.

  • Page 14: Nox Noxturnal

    Nox Noxturnal The Noxturnal application interacts with the Nox T3 device. It allows the configuration of the device as well as navigating, analyzing and archiving recordings from the device. System Requirements The following tables show the minimum and recommended hardware requirements needed to operate...

  • Page 15: Installation

    Installation Administrative privileges are needed to install Noxturnal. To install the application perform the following steps: Run the setup.exe file on the installation DVD An installation wizard will appear: Press Next Select an installation location and then press Next Hook-Up ●...
  • Page 16 Type in the location for the shortcut for the application and then press Next This 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 ●...
  • Page 17 This 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 The application is now being installed on your computer. The progress bar gives an indication of the progress during installation Hook-Up ●...

  • Page 18: Running The Software

    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 ●...

  • Page 19: Configuring The Device

    Configuring the Device To configure the Nox T3 device perform the following steps: Run the Noxturnal application Connect your device to a USB port on your PC using the USB cable delivered with the system.
  • Page 20 Once the device is detected, press the Configure Device tab and view the following sheet: Type in information about the subject being recorded in the Subject Info section, e.g. name, age, address, gender, height and weight Configure the conditions for starting the recording in the Recording Time section. The simplest option is to Manually Start Recording.

  • Page 21: Viewing Recorded Data

    To be able to use the pulse oximeter module in the recording it needs to be paired to the Nox T3 device. Select the appropriate oximeter from the drop down list. In case the oximeter to be used is not shown in the drop down list type in the ID code for that pulse oximeter,. 10.
  • Page 22 Recording statistics: A table containing key parameters of statistics calculated from the raw underlying data and marked events for each night recorded: AHI (number of Apneas + Hypopneas per hour), • Apnea Index (number of Apneas per hour), • Hypopnea Index (number of Hypopneas per hour), •...

  • Page 23: Hook-Up

    Make sure the device has been configured correctly Make sure the carry bag contains all equipment needed to finish the study, including batteries Provide the patient with the Nox T3 Hook Up Card ► Children should under no occasion hook up the system.
  • Page 24 thorax by fasten the clip strap to the night- clothing of the patient Step 2: Place the respiratory effort sensor around the patient’s thorax by snapping its ends to the back panel of the device Step 3: The belt length is adjusted using the sliders.

  • Page 25: Recording Of Respiratory Sounds And Snoring

    ► The device and respiratory effort sensors (belts) should be worn over night-clothing. ► The belt should fit the patient snugly without being uncomfortably tight. Recording of Respiratory Sounds and Snoring No applying of external sensor is needed for recording of respiratory sounds and snoring as the devices uses an inbuilt microphone.

  • Page 26: Pulse Oximeter Module

    ► To avoid the risk of confusing or misinterpreting patient data, verify that the patient module is paired with the correct Nox T3 device. ► This pulse oximetry system might misinterpret motion as good pulse quality.

  • Page 27: Precautions For Use Of The Pulse Oximeter

    Precautions for Use of the Pulse Oximeter ► Oximeter readings may be affected by the use of an electrosurgical unit (ESU) ► This pulse oximetry system is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement.

  • Page 28: System Maintenance

    No part of the Nox T3 system requires sterilization. Nox T3 Device: Clean the device with a soft cloth dampened with hospital grade cleaner that is not corrosive to plastic or metal. Do not pour or spray any liquids onto the device, and do not allow any liquids to enter any openings in the device.

  • Page 29: Specification

    Specification Nox T3 Device Description Properties Function Storage capacity 1GByte Recording time Nominal 24 hours with new or fully charged battery Bipolar inputs Touch proof DIN 42-802 Physical Device Dimension 79mm (3.11”) W, 63mm (2.48”)H, 21mm(0.83”) D Weight 65 gram (88 gram with battery)

  • Page 30: Nasal Cannula

    Nasal Cannula Description Properties Physical Filter Hyrophilic Filer with Female Luer Lock Inlet Environmental Storage Store in a cool dry place Material Cannula PVC/Silicon Filter Acryl Pulse Oximeter Module Description Properties Range Oxygen Saturation Range 0-100% (%SpO2) Pulse Rate Range 18-300 pulse per minute Accuracy Blood Oxygen Saturation...

  • Page 31: Classifications

    ► ISO 13485 Medical devices – Quality Management systems – Requirements for regulatory purposes. The manufacturing site of the Nox T3 device is certified according to ISO 13485. ► EN 300 328 Electromagnetic compatibility and Radio Spectrum Matters (ERM); Wideband Transmission systems;...

  • Page 32: Emc - Information

    Commission (FCC) and Canadian Ministry of Health Rules for Electromagnetic Compatibility The Nox T3 device complies with Part 15 of the FCC Rules and RSS 210 of Industry Canada. Operation is subject to the following two conditions: This device may not cause harmful interference, and This device must accept any interference, including interference that may cause undesired operation of this device.
  • Page 33 Specific Absorption Rate (SAR) Ministry of Health (Canada), Safety Code 6: standards include substantial safety margin designed to ensure the safety of all persons, regardless of age and health. The Specific Absorption Rate or SAR is a measure of the rate at which electromagnetic energy is absorbed into the body. The SAR limit for the general public is 1.6W/kg for the trunk and 4W/kg for the limbs.

  • Page 34: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Nox T3 system is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

  • Page 35: Recommended Separation Distance Between Portable And Mobile Rf Communications Equipment And The Nox T3 Device

    To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Nox T3 device is used exceeds the applicable RF compliance level above, the Nox T3 device should be observed to verify normal operation.

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