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nox A1 Manual

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Copyright 2017 Nox Medical

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Aissa Desalisa
July 5, 2025

IF THE POSITION IS -45 WHAT ISTHAT POSITION FOR RIP BELTS

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Summary of Contents for nox A1

  • 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 A1 Status ............................. 15 Nox A1 Patient Hookup .......................... 16 Inserting a Battery to the Nox A1 ...................... 16 Attaching the Nox A1 and the Nox RIP Belts ..................17 Attaching the Nox Nasal Cannula ...................... 19 Measuring Mask Pressure........................20 Measuring EEG Signals ........................
  • Page 4 Configuring the Oximeter Setup ......................28 Maintenance............................29 Compatible Sensors and Devices ......................32 Specifications ............................37 Nox A1 and Accessories ........................37 Material Information ......................... 39 Nox A1 Battery Information ....................... 40 Regulatory Information .......................... 41 Performance Testing and Validation Summary ................. 41 Nox A1 Classifications ........................

  • Page 5: List Of Abbreviations

    Nox A1 Manual List of Abbreviations AASM American Academy of Sleep Medicine 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...
  • Page 6 Nox A1 Manual Radio Frequency 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

    Nox Sleep System. The use of the Noxturnal software application that is needed for device configuration, data download, review, and analysis as well as the use of the Nox C1 Access Point that is needed for the online setup of the Nox Sleep System are covered in: •...

  • Page 8: Instructions For Operators

    International Special Committee on Radio Interference (CISPR) emission requirements, causing possible patient harm.  Caution: The Nox A1 recorder is designed to be safe for use for pacemaker patients if the pacemakers comply with the standard: EN 50061 Safety of Implantable Cardiac Pacemakers.
  • Page 9 Using non-compliant pacemakers may result in the operation of the pacemaker being affected by the use of Nox A1 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 10 System, only use accessories that have been validated for use by Nox Medical.  Warning: Remove batteries from the Nox A1 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 A1 Description

    Nox A1 Manual Nox A1 Description The Nox A1 is a body worn sleep recorder. The input channels and built-in capabilities of the device include the following: • 13 unipolar channels; for recording of electroencephalography (EEG), electrooculography (EOG) and submental electromyography (EMG) •...
  • Page 12 Nox A1 Manual NUMBER FUNCTION INPUT/SENSOR LABEL Display Push button – Middle White square Push button – Forward White arrow pointing right Push button – Backward White arrow pointing left 2 Clip strap loops Microphone – For recording of respiratory sounds...

  • Page 13: Operating Nox A1

    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 A1 System Kit , on the battery lid pin and slide the battery lid down, towards the bottom of the device. The Nox A1 recorder connects to the computer by using Nox mini USB cable.

  • Page 14: Manually Starting/Stopping Nox A1

    Nox A1 Manual Manually Starting/Stopping Nox A1 If the Nox A1 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”.

  • Page 15: Starting Nox A1 At A Scheduled Time

    Nox A1 Status The indicator light on the Nox A1 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 16: Nox A1 Patient Hookup

    IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries. Before you start a recording, you should make sure that the Nox A1 recorder has a new or fully charged battery. To insert a new battery, do the following: 1.

  • Page 17: Attaching The Nox A1 And The Nox Rip Belts

    • 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.
  • Page 18 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.

  • Page 19: Attaching The Nox Nasal Cannula

    Nox A1 recorder. If it is preferred to use a non-filtered Luer-lock cannula, it is necessary to use a filter tube connector from Nox Medical to interface with the Nox A1 recorder.

  • Page 20: Measuring Mask Pressure

    Nox A1 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 A1 recorder via a filter tube connector from Nox Medical.
  • Page 21 Connect the Nox EEG Head Cable to the E2-E1, F4-F3, C4-C3, O2-O1, M2-M1 unipolar and ground inputs of the Nox A1 recorder. Place a snap-on electrode on the middle of the patient’s forehead. Route the Nox EEG Head Cable behind the patient’s head and snap the cable to the electrode.

  • Page 22: Measuring Emg/Ecg Signals

    The Nox A1 recorder is equipped with 4 bipolar channels suitable for recording of ECG and EMG signals such as leg EMG or masseter EMG for bruxism detection. The bipolar channels are labeled with GP1, ECG, LM1, and LM2 and connect to bipolar electrode leads with keyhole connectors.
  • Page 23 Nox A1 Manual For submental EMG, insert the electrode leads into the EMG channels of the Nox A1 recorder and attach the electrodes to the patient’s chin. The front chin electrode goes into the F input, the left chin electrode goes into the 1 input, and the right chin electrode goes into the 2 input.

  • Page 24: Measuring Data From Auxiliary Devices

    The Nox A1 recorder can 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.

  • Page 25: Inserting Batteries Into The Nonin 3150 Pulse Oximeter

    The Nox A1 recorder can communicate with an auxiliary Bluetooth® pulse oximeter for recording of oxygen saturation levels (SpO ), pulse rate, and plethysmography data.

  • Page 26: Selecting Oximeter Sensor Size

    For digit 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 A1 system kits includes: • Model 3150, WristOx Pulse Oximeter •...
  • Page 27 Nox A1 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 the finger. ~ 27 ~...

  • Page 28: Configuring The Oximeter Setup

    Use the Noxturnal software or the Noxturnal App to establish the Bluetooth connection between the Nonin 3150 oximeter and the Nox A1 Recorder. The connection is established by entering the Bluetooth address (BDA) of the oximeter in the recording configuration.

  • Page 29: Maintenance

    No regular testing of the Nox A1 recorder or accessories, including patient cables, is needed. The service life of the Nox A1 recorder and Nox A1 carry case is 5 years. The service life of Nox A1 head cables is 1 year. The service life of Nox EEG cup sets is 6 months.
  • Page 30 Allow the unit to dry thoroughly before use. All cables provided by Nox Medical to be used with the Nox A1 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 31 Nox A1 Manual Disposal Follow local governing ordinances and recycling instructions regarding disposal or recycling of this device and accessories, including batteries.  According to the regulation in Europe on Waste of Electrical and Electronic Equipment (WEEE) the components labeled with this symbol may not be disposed of as unsorted municipal waste.

  • Page 32: Compatible Sensors And Devices

    The following table includes information on accessories, sensors and devices that have been validated with the Nox A1 recorder. The items listed below are Nox products and have been validated for use with the Nox A1 recorder: NOX DISPOSABLE RIP BELTS...
  • Page 33 Type Catalogue Number Nox Snap-on Lead 50 cm, white, 1.5mm connector, 2 units 554020 Nox Snap On Lead 30 cm, beige-white, 1.5 mm connector, 2 units 554021 Nox Snap On Lead 100 cm, green, 1.5 mm connector, 1 unit 554022 Nox Snap On Lead 50 cm, beige-green, 1.5 mm connector, 1 unit...
  • Page 34 Nox W7 Link Kit - R 544011 NOX W7 Link Kit – A 544012 The items listed below are 3 party products and have been validated for use with the Nox A1 recorder: PULSE OXIMETERS Type Catalogue Number Nonin WristOx...
  • Page 35 Nox A1 Manual NONIN WristOx Flex Sensor with 25 Flexi Wraps, 30 cm (12 in) cable – Adult 553130 NONIN WristOx Wrist Band 564042 DIFFERENTIAL PRESSURE SENSOR Type Catalogue Number Differential Pressure Sensor Kit 547010 THERMAL FLOW SENSORS Type Catalogue Number...
  • Page 36 Nox A1 Manual CLEANING Type Catalogue Number Super Sani-Cloth Plus Disinfection Wipes 559010 ~ 36 ~...

  • Page 37: Specifications

    Nox A1 Manual Specifications Nox A1 and Accessories DESCRIPTION PROPERTIES FUNCTION  Nox A1 Storage Capacity 1GByte  Nox A1 Recording Time 8 hours  Nox A1 Internal Channels Two RIP Respiratory Effort  Pressure  Respiratory sound/snoring  Four bipolar ...
  • Page 38 Nox A1 Manual  Storage rate = 200 Hz  Nox A1 Pressure Sensor Pressure input range: ±100 cmH  Proprietary Nox Connector Nox EEG Head Cable  Head-end connector: Proprietary Nox Connector  Device-end connector: Proprietary Nox Connector ...

  • Page 39: Material Information

    Device-end connectors: Gold-plated contacts, TPE  USB Micro Connector: gold-plated contacts  Connector Pins at Device End: gold-plated contacts  Nox EEG 5 Lead Electrode Cable Jacket: PVC Cables  USB Micro Connector: gold-plated contacts, TPE  Electrode Cups: Gold-plated copper, TPE overmold ...

  • Page 40: Nox A1 Battery Information

    IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries.  Note: The recording durations listed below depend on the quality of the batteries used. The list below is provided to assist the user in selecting the appropriate battery type for the Nox A1 study: •...

  • Page 41: Regulatory Information

    Nox Medical with the Nox A1 recorder is considered to be a modification of the Nox Sleep System. Such modifications could result in the system not performing as intended and cause serious harm to the patient.
  • Page 42 Nox A1 Manual  Manufacturer information  Date of manufacture  Do not re-use  Serial number  Batch code / Lot number  Catalogue number / Reference number  Unique Device Identifier (UDI); the Application Identifier (01) represents the device identifier (DI) (“1569431111XXXX”), the Application Identifier (11) the...
  • Page 43 Nox A1 Manual  FCC ID label FCC ID: ED9LMX9838  Revision of device  Bluetooth® wireless technology  Temperature limit  Humidity limitation  Atmospheric pressure limitation  Keep dry  Fragile, handle with care  Degree of protection against harmful ingress of water or...

  • Page 44: 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 (E MC) Information ...
  • Page 45 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. ~ 45 ~...
  • Page 46 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Nox A1 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 47 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Nox A1 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 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 A1 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 49 Recommended separation distance between portable and mobile RF communications equipment and the Nox A1 Recorder The Nox A1 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 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. Electronic versions are provided as PDF documents and a PDF reader is required to open the documents.

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