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Nox Medical T3 Manual

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Copyright 2017 Nox Medical

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Summary of Contents for Nox Medical T3

  • Page 1 Manual Copyright 2017 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

    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 ........................
  • Page 4 Nox T3 Manual 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 ..........................

  • Page 5: List Of Abbreviations

    Nox T3 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 T3 Manual Respiratory Inductance Plethysmography 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 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®...

  • Page 8: Warnings And Cautions For Use

    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.
  • Page 9  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.
  • Page 10 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.

  • Page 11: Nox T3 Description

    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.
  • Page 12 Nox T3 Manual Pressure lock – Connects to external nasal cannula/mask pressure tube Channel 1 – Bipolar touch proof inputs Channel 2 – Bipolar touch proof inputs Reference ground input for channels 1 and 2 Microphone – For recording of respiratory sounds...

  • Page 13: Operating Nox T3

    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.

  • Page 14: Starting Nox T3 At A Scheduled Time

    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.
  • Page 15 Nox T3 Manual 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.
  • Page 16 Nox T3 Manual 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 cmH 0.

  • Page 17: 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.

  • Page 18: Inserting A Battery To The Nox T3

     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.
  • Page 19 Nox T3 Manual 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.
  • Page 20 Nox T3 Manual 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.

  • Page 21: Attaching The Nox Nasal Cannula

    Nox T3 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 T3 recorder.

  • Page 22: Measuring Mask Pressure

    Nox T3 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 T3 reorder via a filter tube connector from Nox Medical.

  • Page 23: Measuring Pulse And Oxygen Saturation Using Nonin 3150 Pulse Oximeter

    The Nox T3 recorder is able to communicate with supported auxiliary devices over a Bluetooth® link by use of the Nox W7 link; for more information refer to the user instructions accompanying the Nox W7 link kits and further information can also be found on the Nox Medical Support Site.

  • Page 24: Inserting Batteries Into The Nonin 3150 Pulse Oximeter

    The Nox T3 recorder can communicate with an auxiliary Bluetooth® pulse oximeter for recording of oxygen saturation levels (SpO ), pulse rate, and plethysmography data.

  • Page 25: Attaching The Nonin 3150 Pulse Oximeter And Soft Sensor

    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 Pulse Oximeter and Soft Sensor The Nonin 3150 WristOx Oximeter package accompanying the Nox T3 system kits includes: • Model 3150, WristOx Pulse Oximeter •...
  • Page 26 Nox T3 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. ~ 26 ~...

  • Page 27: Establish A Connection Between The Nonin 3150 Pulse Oximeter And Nox T3

    Before you can send out the Nox T3 recorder and accessories for an ambulatory recording, you need to make sure that a connection has been established between the Nox T3 recorder and the oximeter. The pairing of the Nox T3 recorder and the oximeter is done after you have finished the configuration ®...
  • Page 28 Step 3. Turning on the Nox T3 Turn on the Nox T3 recorder by pressing the Middle button. Hold the Middle button until you see the screen turning on. Then press the Right button once or until you see the message “Connecting to” and a PIN address displayed on the Nox T3 recorder.
  • Page 29 During the programming the Nox T3 will show the following display: A checkmark on the Nox T3 signifies a successful and a correct pairing of the Nox T3 and the oximeter: The Nox T3 system is now ready to be packed and sent along with the patient.
  • Page 30 1. If an X-mark appears instead of a checkmark: This means that the pairing of the Nox T3 recorder and the oximeter has not been achieved and the programming of the oximeter failed. It is necessary to start the pairing process again. Before that can be done the oximeter needs to be restarted.
  • Page 31 Incorrect PIN number If the numbers do not match as is shown in the figure below the Nox T3 is unable to connect to the oximeter and is stuck in the “connecting to” display screen.

  • Page 32: Maintenance

    “connecting to” display screen, try to reboot the Nox T3 recorder. This is done by simply waiting for the Nox T3 to turn off (it turns off automatically in 2 minutes after it has been turned on) and then turn on the Nox T3 again by pushing the middle button. Then resume the pairing process from step 3 above.
  • Page 33 All reusable components should be cleaned between each patient use. Clean the Nox T3 recorder 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 on the device.
  • Page 34 Nox T3 Manual All cables provided by Nox Medical to be used with the Nox T3 recorder are reusable. Clean the cables with a moist cloth using hospital grade cleaner. Do not immerse the cables in liquid and avoid contact of the cleaning solution with the connectors.

  • Page 35: Compatible Sensors And Devices

    Un-authorized modifications could result in the device not performing as intended and cause serious harm to the patient.  Note: To ensure patient safety and effective use of the Nox T3 system, only use accessories that have been validated for use by Nox Medical.
  • Page 36 Nox T3 Manual NOX T3 SYSTEM COMPONENTS Type Catalogue Number Nox Abdomen Cable 562010 Nox USB Cable 562011 Nox T3 Carry Case 568010 Nox Service Kit 569010 Nox Battery Lid 569011 Nox Clip Strap 569013 Nox Battery Lid Key 569014...
  • Page 37 Nox W7 Link Kit – R 544011 Nox W7 Link Kit – S 544010 The items listed below are 3 party products and have been validated for use with the Nox T3 recorder: LEADS AND ELECTRODES Type Catalogue Number Blue Sensor® Snap on Electrode, 50 units...
  • Page 38 Nox T3 Manual PULSE OXIMETER ACCESSORIES Type Catalogue Number NONIN WristOx Soft Sensor – Small 553010 NONIN WristOx Soft Sensor – Medium 553020 NONIN WristOx Soft Sensor – Large 553030 NONIN Flex Sensor with 25 Flexi Wraps, 1 m (39 in) 553110 cable –...

  • Page 39: Specifications

    Nox T3 Manual Specifications Nox T3 and Accessories DESCRIPTION PROPERTIES FUNCTION Nox T3 Storage Capacity  1GByte  Nox T3 Recording Time Nominal 24 hours with new lithium battery  Nox T3 Internal Channels Two RIP Respiratory Effort  Pressure ...
  • Page 40 Nox Filter Tube Connector Hydrophobic filter with female Luer-lock inlet - diameter of 13 mm (0.51 in), with a 0.45 μm filtering capability POWER  Nox T3 Power Source One 1.5 V AA battery  Host PC (data configuration and download) ...

  • Page 41: Material Information

    Cable wire: Tinsel  Connector: Gold-plated spring socket contacts, Riteflex®  Snap: Nickel-plated brass socket, Riteflex®  Nox T3 Carry Case External Part: BLK 600D POLYESTER  Internal Part: Polyethylene (PE) foam Nox Disposable RIP Belts  Belt Elastic: Polyester/Dorlastan ...

  • Page 42: Nox T3 Battery Information

     Note: Further information on multiple night recordings can be found on the Nox Medical Support Site. The list below is provided to assist the user in selecting the appropriate battery type for Nox T3 study: • Alkaline batteries can be used to record from 8 to 16 hours depending on battery type.

  • Page 43: Regulatory Information

    Nox Medical towards the MDD. Use of other components than verified, validated or recommended by Nox Medical is considered to be a modification of the Nox T3 system. Such modifications could result in the system not performing as intended and cause serious harm to the patient.

  • Page 44: Description Of Symbols And Labels

    Nox T3 Manual Description of Symbols and Labels  / Consult instructions for Operating instructions  Manufacturer information  Date of manufacture  Do not re-use  Serial number  Batch code / Lot number / Reference number  Catalogue number ...

  • Page 45:  Bluetooth Wireless Technology

    Bluetooth® Wireless Technology The Nox T3 recorder uses Bluetooth 2.0 wireless technology to receive signals from external Bluetooth modules. The Bluetooth wireless technology is based on a radio link that offers fast and reliable transmission of data.

  • Page 46: Electromagnetic Compatibility (Emc) Information

    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 47 RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website: http://www.hc-sc.gc.ca/ewh- semt/pubs/radiation/radio_guide-lignes_direct/index-eng.php. MODIFICATION STATEMENT Any changes or modifications not expressly approved by Nox Medical could void the user’s authority to operate the equipment. ~ 47 ~...
  • Page 48 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Nox T3 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 49 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Nox T3 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 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 recorder is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
  • Page 51 Recommended separation distance between portable and mobile RF communications equipment and the Nox T3 Recorder The Nox T3 recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

  • Page 52: 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. Electronic versions are provided as PDF documents and a PDF reader is required to open the documents.

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