Nox Medical T3S Manual
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Nox Medical T3S Manual

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Copyright 2020 Nox Medical

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Summary of Contents for Nox Medical T3S

  • Page 1 English Copyright 2020 Nox Medical...
  • Page 2 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.

  • Page 3: Table Of Contents

    Connecting Nox T3s to a Computer ....................13 Configuring and Downloading from Nox T3s ..................13 Establishing a Connection between the Nonin 3150 BLE Pulse Oximeter and Nox T3s ....13 Manually Starting/Stopping the Nox T3s ................... 18 Starting Nox T3s at a Scheduled Time ....................19 Nox T3s Status ...........................
  • Page 4 Nox T3s Manual Maintenance ............................31 Compatible Sensors and Devices ......................34 Specifications ............................38 Nox T3s and Accessories ........................38 Material Information ......................... 40 Nox T3s Battery Information ......................41 Regulatory Information .......................... 42 Performance Testing and Validation Summary ................. 42 Nox T3s Classifications ........................

  • Page 5: List Of Abbreviations

    Nox T3s Manual List of Abbreviations Acrylonitrile Butadiene Styrene Body Mass Index CISPR Comité International Spécial des Perturbations Radioélectriques (English: International Special Committee on Radio Interference) CMDR Canada Medical Device Regulations Electrocardiography Electroencephalography Electromyography Electromagnetic compatibility Electrooculography Electrostatic discharges Federal Communications Commission...
  • Page 6 Nox T3s Manual SpO2 Oxygen Saturation Levels measured by pulse oximetry Thermoplastic Elastomer WEEE Europe on Waste of Electrical and Electronic Equipment ~ 6 ~...

  • Page 7: Introduction

    Congratulations on choosing the Nox T3s™ recorder. The Nox T3s is an ambulatory body worn sleep recorder and is a part of the Nox T3s system. Its main function is to record physiological signals during sleep by use of built-in sensors and patient applied sensors. The Nox T3s recorder has a built-in Bluetooth®...

  • Page 8: Instructions For Operators

    Medical’s website: www.noxmedical.com/distributors. Warnings and Cautions for Use  Warning: The Nox T3s System is NOT certified to be used for continuous monitoring where failure to operate can cause injuries or death of the patient.  Caution: U.S. federal law restricts this device to sale by, or on the order of, a licensed medical practitioner.
  • Page 9 If in doubt, contact a qualified medical technician or your local representative.  Caution: The Nox T3s recorder is designed to be safe for use for pacemaker patients if the pacemakers comply with the standard: EN 45502-2-1 Active implantable medical devices.
  • Page 10 Nox Medical. Refer to section “Compatible Sensors and Devices”.  Warning: Remove batteries from the Nox T3s recorder if it is not used within 30 days to prevent damage from possible battery leakage and prevent possible minor burns to the operator/patient.

  • Page 11: Nox T3S Description

    The Nox T3s recorder is powered with one AA battery. Nox T3s Interface The Nox T3s recorder interface consists of a display, buttons, sensor inputs/connections and a USB connector. The USB connector is placed under the battery lid and connects to a USB Type-C cable for device configuration and data download.
  • Page 12 Nox T3s Manual 2 Clip strap loops Microphone – For recording of respiratory sounds Pressure lock (labeled with “PRES”) – Connects to external nasal cannula/mask pressure tube Channel 1 & 2 (labeled with “1” and “2”) – Bipolar touch proof inputs Reference ground input for channels 1 and 2 (labeled with “PGND”) –...

  • Page 13: Operating Nox T3S

    Connecting Nox T3s to a Computer To connect Nox T3s recorder to a computer you need to access the USB connector on the device. The USB connector is placed under the battery lid making it inaccessible and tamper proof for children. To open the battery lid, press with the Nox battery Lid Key, accompanying the Nox T3s system kit, on the battery lid pin and slide the battery lid down, towards the bottom of the device.
  • Page 14 Turn on the Nonin 3150 BLE pulse oximeter by pressing the gray activation button (red circle on the picturee below) on tope of the device and you will see the display turn on. Step 3. Connect the Nox T3s recorder with a USB cable and follow the configuration in Noxturnal...
  • Page 15 Nox T3s Manual Click Pair with Oximeter and the pairing will be performed either result in a successful pairing Or an unsuccessful paring ~ 15 ~...
  • Page 16 Bluetooth Wake up Mode. That is indicated by the Bluetooth symbol blinking on regular time interval of the study. The Nonin 3150 BLE will then turn on when the Nox T3s recorder starts a study (either manual start or scheduled start)
  • Page 17 Verify that the BDA number of the oximeter used matches the number used to configure the Nox T3s Recorder. The BDA number used in configuration of the Nox T3s can be found on in the display of the device that shows the status of the oximeter connection. The oximeter BDA number is displayed on the back of the oximeter.

  • Page 18: Manually Starting/Stopping The Nox T3S

    Nox T3s Manual Correct BDA number but oximeter still marked with “x” on status display: This means that the Nox T3s recorder and the oximeter are not pairing as expected. To resolve try the following: Restart the oximeter by removing the batteries and inserting batteries again to the oximeter.

  • Page 19: Starting Nox T3S At A Scheduled Time

    Nox T3s Status Indicator Light The indicator light on the Nox T3s recorder blinks green when a recording is in progress and the device is functioning normally. When there are any device warnings the indicator light blinks amber. Warnings might include: •...
  • Page 20 Bluetooth connection, a “✓” means there is a Bluetooth connection. 2. The device’s clock. When Nox T3s is configured, the clock is synchronized with the PC and is shown at the top of the display. 3. On the top right corner is a battery indicator which shows the battery status.
  • Page 21 Nox T3s Manual 1. Status of scheduled recordings. number squares represent number recordings scheduled. A full square represents a recording that has already been recorded successful. An empty square represents a recording yet to be performed. Examples of the multiple night status indicator and their meanings can be seen below: Three empty squares: The device has been configured to record three nights, but no recording has been performed.

  • Page 22: Nox T3S Patient Hookup

    Inserting a Battery to the Nox T3s The list below is provided to assist the user in selecting the appropriate battery type for a Nox T3s study: • Alkaline batteries can be used to record from 8 to 16 hours depending on battery type.

  • Page 23: Attaching The Nox T3S And The Nox Rip Belts

     Note: Further information on multiple night recordings can be found on the Nox Medical Support Site. Before you start a recording, you should make sure that the Nox T3s recorder has a new or fully charged battery. To insert a new battery, do the following: 1.
  • Page 24 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. Step 5 Attaching the Nox T3s recorder and Nox disposable RIP belts is now completed. ~ 24 ~...

  • Page 25: Attaching The Nox Nasal Cannula

    Nox T3s recorder. If you use a non-filtered Luer-lock cannula, it is necessary to use a filter tube connector from Nox Medical to interface with the Nox T3s recorder.

  • Page 26: Measuring Mask Pressure

    Nox T3s recorder by using the Nox filter tube connector. A mask pressure tube is used for connection to positive airway pressure (PAP) masks for measuring mask pressure. The pressure tube connects to the pressure lock on the Nox T3s recorder via a filter tube connector from Nox Medical.

  • Page 27: Measuring Pulse And Oxygen Saturation Using Nonin 3150 Ble Pulse Oximeter

    The Nox T3s recorder can record any combination of two ExG channels, that is, EMG, EOG, EEG or ECG. The electrode leads connect to the bipolar touch-proof inputs on the Nox T3s recorder. The electrodes are placed on applicable locations on the body depending on the type of recording.

  • Page 28: Inserting Batteries Into The Nonin 3150 Ble Pulse Oximeter

    Do not mix fully charged and partially charged batteries at the same time. These actions may cause the batteries to leak. The Nox T3s recorder can communicate with an auxiliary Bluetooth® pulse oximeter for recording of oxygen saturation levels (SpO ), pulse rate, and plethysmography data.

  • Page 29: Selecting Oximeter Sensor Size

    For finger height from 12.5 mm (0.5 in) to 25.5 mm (1.0 in), size large should be selected. Attaching the Nonin 3150 BLE Pulse Oximeter and Soft Sensor The Nonin 3150 BLE WristOx oximeter package accompanying the Nox T3s system kits includes: • WristOx ®...
  • Page 30 Nox T3s Manual Step 5 to Step 6  Note: To prevent the oximeter sensor from falling off, secure its cable with medical tape. 5. Place the wristband around the patient’s wrist. 6. Put the probe on a finger. ~ 30 ~...

  • Page 31: Maintenance

    No regular testing of the Nox T3s recorder or accessories, including patient cables, is needed. The service life of the Nox T3s recorder and Nox T3s carry case is 5 years or the equivalent of 1000 studies in total, given that 200 studies are performed in a year.
  • Page 32 The Nox T3s recorder is factory calibrated. No further calibration is needed. Cleaning of Nox T3s and its Accessories  Warning: Do not autoclave or immerse the Nox T3s recorder and accessories in any kind of liquids. Ingress of liquids may result in electric shock.
  • Page 33 Inspect for surface wear, discoloration, corrosion, or cracking. ** If necessary, the clips on the Nox T3s recorder can be removed before cleaning. The cleaning process described above also applies for the clips. If the clips are visibly contaminated, they should be replaced.

  • Page 34: Compatible Sensors And Devices

    The following table includes information on accessories, sensors and devices that have been validated with the Nox T3s recorder. The items listed below are Nox products and have been validated for use with the Nox T3s recorder: NOX DISPOSABLE RIP BELTS...
  • Page 35 Nox T3s Manual NOX T3S SYSTEM COMPONENTS Type Catalogue Number Nox Abdomen Cable, s 561212 Nox T3s Carry Case 568012 Nox Service Kit, s 569015 Nox Battery Lid, s 569020 Nox Clip Strap, s 569021 Nox Battery Lid Key 569014...
  • Page 36 Nox Snap On Lead 100 cm (40 in), Green, 1 unit 554022 Nox Snap On Lead 50 cm (20 in), Beige-Green, 1 unit 554023 The items listed below are 3 party products and have been validated for use with the Nox T3s recorder: LEADS AND ELECTRODES Type Catalogue Number Blue Sensor®...
  • Page 37 Nox T3s Manual USB CABLE Type Catalogue Number USB Type-C Cable 562016 CLEANING Type Catalogue Number PDI Sani-Cloth Plus Germicidal Disposable Cloth 559010 Sani-Cloth AF Universal - Alcohol free Disinfection Wipes 559011 ~ 37 ~...

  • Page 38: Specifications

    Nox T3s Manual Specifications Nox T3s and Accessories DESCRIPTION PROPERTIES FUNCTION  Nox T3s Storage Capacity 4GByte  Nox T3s Recording Time Nominal 24 hours with new lithium battery  Nox T3s Internal Channels Two RIP Respiratory Effort  Pressure ...
  • Page 39 Hydrophobic filter with female Luer-lock inlet - diameter of 13 mm (0.51 in), with a 0.45 μm filtering capability POWER  Nox T3s Power Source One 1.5 V AA battery  Host PC (data configuration and download) Nox T3s Battery Type ...

  • Page 40: Material Information

    Unipolar  Cable wire: Tinsel  Connector: Gold-plated spring socket contacts, Riteflex®  Snap: Nickel-plated brass socket, Riteflex®  Nox T3s Carry Case External Part: BLK 600D POLYESTER  Internal Part: PU  Insert: ABS  Nox Disposable RIP Belts Belt Elastic: Polyester/Dorlastan ...

  • Page 41: Nox T3S Battery Information

    Nox T3s Manual Nox T3s Battery Information The list below is provided to assist the user in selecting the appropriate battery type for a Nox T3s study: • Alkaline batteries can be used to record from 8 to 16 hours depending on battery type.

  • Page 42: Regulatory Information

    Nox Medical towards the Medical Devices Directive 93/42/EEC (MDD). Use of other components than verified, validated or recommended by Nox Medical is considered to be a modification of the Nox T3s system. Such modifications could result in the system not performing as intended and cause serious harm to the patient.

  • Page 43: Description Of Symbols And Labels

    Nox T3s Manual Description of Symbols and Labels Operating instructions / Consult instructions for use Manufacturer information Date of manufacture Do not re-use Serial number Batch code / Lot number / Reference number Catalogue number Unique Device Identifier (UDI); the Application Identifier (01) represents the device identifier (DI) (“1569431111XXXX”),...
  • Page 44 Nox T3s Manual 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. For proper treatment, recovery and recycling, please dispose this product to designated municipal recycling center where it will be accepted free of charge.

  • Page 45: Bluetooth® Wireless Technology

    The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Nox Medical is under license. Other trademarks and trade names are those of their respective owners. Electromagnetic Compatibility (EMC) Information ...
  • Page 46 PSG software. This may affect data analysis and result in incorrect interpretation of data.  Warning: The Nox T3s recorder(s) should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device(s) should be observed to verify normal operation in the configuration in which it will be used and prevent abnormal operation which might cause injuries to the operator/patient.
  • Page 47 Standard: Electromagnetic disturbances - Requirements and Tests. ELECTROMAGNETIC EMISSIONS The Nox T3s recorder 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 48 Nox T3s Manual ELECTROMAGNETIC IMMUNITY The Nox T3s recorder 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. Immunity test IEC 60601 test level...
  • Page 49 IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT The Nox T3s recorder 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 50: About

    Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices. They are also available in electronic format on Nox Medical’s website: www.noxmedical.com/ifu. Electronic versions are provided as PDF documents and a PDF reader is required to open the documents.

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