Nox Medical A1 Manual
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Nox Medical A1 Manual

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Copyright 2020 Nox Medical

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  • Page 1 US Manual Copyright 2020 Nox Medical...
  • Page 2 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. License Notice The Nox A1 recorder’s firmware contains BIGDIGITS multiple-precision arithmetic code originally written by...

  • Page 3: Table Of Contents

    Nox A1 Status ............................. 16 Nox A1 Patient Hookup ............................17 Inserting a Battery to the Nox A1 ...................... 17 Attaching the Nox A1 and the Nox RIP Belts..................18 Attaching the Nox Nasal Cannula ...................... 19 Measuring Mask Pressure ........................20 Measuring EEG Signals ........................
  • Page 4 Configuring the Oximeter Setup ......................30 Maintenance ................................. 31 Compatible Sensors and Devices .......................... 36 Specifications ................................ 40 Nox A1 and Accessories ........................40 Material Information ......................... 42 Nox A1 Battery Information ....................... 43 Regulatory Information ............................44 Performance Testing and Validation Summary ................. 44 Nox A1 Classifications ........................

  • Page 5: List Of Abbreviations

    Nox A1 US 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) CPAP Continuous positive airway pressure Electrocardiography Electroencephalography...
  • Page 6 Nox A1 US Manual Respiratory Inductance Plethysmography SpO2 Oxygen Saturation Levels measured by pulse oximetry Thermoplastic Elastomer ~ 6 ~...

  • Page 7: Introduction

    Congratulations on choosing the Nox A1 recorder. The Nox A1 recorder is a body worn sleep recorder intended to be worn over clothing or pajama. The Nox A1 recorder is a part of the Nox Sleep System. Its main function is to record physiological signals by use of built-in sensors and patient applied sensors.

  • Page 8: Instructions For Operators

    Nox Sleep System and cause injuries to the operator/patient.  Warning: The Nox A1 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 The patient might perform the hook-up on him/herself or with the assistance of a family member when conducting a simple PG study in the home environment (similar as with the Nox T3 recorder).
  • 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 manufacturer.
  • Page 10 Nox Medical. Refer to section “Compatible Sensors and Devices”.  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 Using the product for electrical stimulation purposes might create burns and cause injuries to the patient.  Caution: The Nox A1 recorder and its accessories should always be transported in the accompanying carrying case to ensure adequate protection and prevent damage.

  • Page 12: Nox A1 Description

    Nox A1 US 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 13 Nox A1 US 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 14: Operating Nox A1

    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 15: Configuring And Downloading From Nox A1

    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 16: Starting Nox A1 At A Scheduled Time

    Middle button turns it on. The display will turn itself off again after being inactive for about 20 seconds. When Nox A1 is configured the clock is synchronized with the PC and is shown at the top of the display.

  • Page 17: Nox A1 Patient Hookup

     Note: All lithium batteries used with the Nox A1 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 A1 recorder has a new or fully charged battery. To insert a new battery, do the following: 1.

  • Page 18: Attaching The Nox A1 And The Nox Rip Belts

    Attaching the Nox A1 and the Nox RIP Belts  Caution: The Nox A1 recorder and Nox disposable RIP belts should be worn over clothing to prevent allergic reaction to the equipment materials.

  • Page 19: Attaching The Nox Nasal Cannula

    Nox A1 US Manual Attaching the Nox A1 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 20: Measuring Mask Pressure

    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: Measuring Eeg Signals

    Connect the Nox A1 EEG Head Cable to the E2-E1, F4-F3, C4-C3, O2-O1, M2-M1 unipolar and ground inputs of the Nox A1 recorder.
  • Page 22 C3/C4, the grey wire is for O1/O2 and the red wire is for M1/M2. Optionally instead of using the customized Nox A1 EEG 5 Lead Gold Electrode Cables and Nox A1 EEG Head Cable, eleven standard gold cup electrode leads may be used that connect to the unipolar inputs on the Nox A1 Recorder.

  • Page 23: 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 possible bruxism-related event detection. The bipolar channels are labeled with GP1, ECG, LM1, and LM2 and connect to bipolar electrode leads with keyhole connectors (Nox Snap On Double Leads) that snap on to surface electrodes.
  • Page 24 Nox A1 US Manual Before electrodes are placed it is important to inspect the skin locations and make sure the electrodes are placed on a dry and clean location that has no small abrasions and wounds. To prepare the skin, it is recommended to clean the skin with water and abrasive skin prepping gel.

  • Page 25: Measuring Data From Auxiliary Devices

    Bluetooth format. Refer to the “Compatible Sensors and Devices” section regarding the types of auxiliary devices that have been validated to work with the Nox A1 recorder by use of the Nox W7 link. For detailed information on how the Nox W7 link is used; refer to the user instructions accompanying the Nox W7 link kits.
  • Page 26 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 27: Inserting Batteries Into The Nonin Wristox2 Pulse Oximeter, Model 3150

    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 WristOx2 Pulse Oximeter, Model 3150 and Nonin WristOx2 Soft Sensor The Nonin 3150 WristOx Oximeter package accompanying the Nox A1 system kits includes: • Model 3150, WristOx Pulse Oximeter •...
  • Page 28 Nox A1 US Manual Step 1 to Step 4 1. Separate the short end of the wristband from the long end. 2. Insert the short end in the loops on the oximeter. 3. Place the probe wire between the short and long end of the wristband. Attach the long end to the short end to secure the wristband on the oximeter.
  • Page 29 Nox A1 US 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.

  • Page 30: Configuring The Oximeter Setup

    Use the Noxturnal US software or the Noxturnal App to establish the Bluetooth connection between the Nonin WristOx2 Pulse Oximeter, Model 3150 and the Nox A1 Recorder. The connection is established by entering the Bluetooth address (BDA) of the oximeter in the recording configuration.

  • Page 31: 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 or the equivalent of 1000 studies in total, given that 200 studies are performed in a year. The service life of Nox A1 EEG Head Cable is 1 year, or 200 studies, and the service life of Nox EEG 5 Lead Gold Electrode Cable is 6 months or 100 studies.
  • Page 32 The Nox A1 recorder is factory calibrated. No further calibration is needed. Cleaning of Nox A1 Recorder and its Accessories  Warning: The Nox A1 recorder is not designed to give a specified degree of protection against harmful ingress of liquids. Do not autoclave or immerse the device, nor any sensor, in any kind of liquids.
  • Page 33 ** If necessary, the clips on the Nox A1 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 United States of America. ** If any component damage occurs during cleaning process, contact Nox Medical immediately at support@noxmedical.com. Do not attempt to use the Nox Sleep System until the device has been inspected and repaired by authorized Nox Medical personnel.
  • Page 35 Nox A1 US Manual Disposal Follow local governing ordinances and recycling instructions regarding disposal or recycling of this device and accessories, including batteries. ~ 35 ~...

  • Page 36: 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 37 * This function needs Noxturnal 5.2 or an earlier version to configure the Nox W7 links. The items listed below are 3 party products and have been validated for use with the Nox A1 recorder: PULSE OXIMETERS ~ 37 ~...
  • Page 38 Nox A1 US Manual Type Catalogue Number Nonin WristOx Pulse Oximeter, Model 3150 541010 PULSE OXIMETER ACCESSORIES Type Catalogue Number NONIN WristOx Soft Sensor – Small 553010 NONIN WristOx Soft Sensor – Medium 553020 NONIN WristOx Soft Sensor – Large...
  • Page 39 Nox A1 US Manual Snap on Electrode Disposable (Ambu), small 25 units 554209 Blue Sensor® Snap on Electrode (Ambu), 50 units 554210 Genuine Grass Gold Cup Electrodes (Natus Manufacturing Limited) with 1.5 mm touchproof connector ELECTRODE APPLIANCES Type Catalogue Number...

  • Page 40: Specifications

    Nox A1 US 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 41 Head-end connector: Proprietary Nox Connector  Device-end connector: Proprietary Nox Connector  Lengths: Adults – 90 cm (35.4”), Pediatric – 70 cm (27.6”)  Nox A1 EEG 5 Lead Electrode Proprietary Nox Connector  Cables 10 mm (0.39”) diameter cup electrodes ...

  • Page 42: Material Information

    Device-end connectors: Gold-plated contacts, TPE  USB Micro Connector: gold-plated contacts  Connector Pins at Device End: gold-plated contacts  Nox A1 EEG 5 Lead Electrode Cable Jacket: PVC  Cables USB Micro Connector: gold-plated contacts, TPE  Electrode Cups: Gold-plated silver, TPE overmold ...

  • Page 43: 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 44: Regulatory Information

    Furthermore, use of other components than verified, validated or recommended by 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 45 Nox A1 US 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 46: Bluetooth® Wireless Technology

     Unsafe for MR (Magnetic Resonance) Environment. Bluetooth® Wireless Technology The Nox A1 recorder uses Bluetooth® 2.0 wireless technology to communicate with external Bluetooth modules. The Bluetooth wireless technology is based on a radio link that offers fast and reliable transmission of data.

  • Page 47: Electromagnetic Compatibility (Emc) Information

    Nox A1 US Manual 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.
  • Page 48 This device must not be co-located or operating in conjunction with any other antenna or transmitter. MODIFICATION STATEMENT Any changes or modifications not expressly approved by Nox Medical could void the user’s authority to operate the equipment. ~ 48 ~...
  • Page 49 General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests 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 50 Nox A1 US Manual 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. Immunity test...
  • Page 51 IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT The 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.

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