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Nox Medical Nox A1s Manual

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Nox A1s Manual
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  • Page 1 Nox A1s Manual English ~ 1 ~...
  • 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 A1s recorder’s firmware contains BIGDIGITS multiple-precision arithmetic code originally written by...

  • Page 3: Table Of Contents

    Inserting Batteries into the Nonin WristOx2 Pulse Oximeter, Model 3150 BLE ........ 29 Selecting Oximeter Sensor Size ......................29 Attaching the Nonin WristOx2 Pulse Oximeter, Model 3150 BLE and Nonin WristOx2 Soft Sensor . 29 Establishing a Connection between the Nonin 3150 BLE Pulse Oximeter and Nox A1s ....31...
  • Page 4 Nox A1s Manual Maintenance ................................. 38 Compatible Sensors and Devices .......................... 43 Specifications ................................ 47 Nox A1s and Accessories ........................47 Material Information ......................... 49 Nox A1s Battery Information ......................50 Regulatory Information ............................51 Performance Testing and Validation Summary ................. 51 Nox A1s Classifications ........................

  • Page 5: List Of Abbreviations

    Nox A1s 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 CPAP Continuous positive airway pressure...
  • Page 6 Nox A1s 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

    Congratulations on choosing the Nox A1s recorder. The Nox A1s recorder is a body worn sleep recorder intended to be worn over clothing or pajamas. The Nox A1s 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. The Nox A1s recorder has a built-in Bluetooth®...

  • Page 8: Instructions For Operators

    Additional material can be found on the Nox Medical Website. Instructions for Operators The Nox A1s recorder is only intended to be set-up and maintained by professionals (healthcare professionals and service personnel) with relevant qualifications and skills according to the instructions given in the “Operating Nox A1s”, “Nox A1s Patient Hookup”...

  • Page 9: Warnings And Cautions For Use

    Using non-compliant pacemakers may result in the operation of the pacemaker being affected by the use of Nox A1s 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 A1s 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 A1s recorder and its accessories should always be transported in the accompanying carrying case to ensure adequate protection and prevent damage.

  • Page 12: Nox A1S Description

    Nox A1s Manual Nox A1s Description The Nox A1s 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 A1s Manual NUMBE FUNCTION INPUT/SENSOR LABEL Display Push button Light sensor located under the push button Indicator light for device status in the push button 2 Clip strap loops Microphone – For recording of respiratory sounds 1 Pressure lock – Connects to nasal cannula/mask...
  • Page 14 Nox A1s Manual Battery lid pin 2 Metal snaps – Connects to thorax RIP belt 2 Metal snaps – Connects to abdomen cable ~ 14 ~...

  • Page 15: Operating Nox A1S

    To connect Nox A1s 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 A1s System Kit, on the battery lid pin and slide the battery lid down, towards the bottom of the device.

  • Page 16: Configuring And Downloading From Nox A1S

    Manually Starting/Stopping Nox A1s If the Nox A1s recorder has been configured to start the recording manually, you can use the button to manually start a recording. Pressing the button turns on the display. The device will instruct you to “Hold button to record".

  • Page 17: Starting Nox A1S At A Scheduled Time

    Starting Nox A1s at a Scheduled Time If the Nox A1s recorder has been configured to automatically start a recording at a scheduled time, there are no actions required for the recording to start. Pressing the button before the recording has started will display a countdown to the specified start time of the recording.
  • Page 18 Nox A1s Manual A Bluetooth symbol and an “X” or a checkmark “ ” are visible on all displays. This symbol shows the status of the Bluetooth connection with the oximeter. An “X” means there is not Bluetooth connection, a “ ”...
  • Page 19 Nox A1s Manual Status scheduled recordings. The number of squares represent the number of recordings scheduled. A full square represents a recording that has already been recorded successfully. 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 20: Nox A1S Patient Hookup

    Inserting a Battery to the Nox A1s The list below is provided to assist the user in selecting the appropriate battery type for a Nox A1s study: • Alkaline batteries can be used to record from 10 to 12 hours depending on battery type.

  • Page 21: Attaching The Nox A1S And The Nox Rip Belts

    Nox A1s Manual 1. Open the battery compartment by pressing down the battery lid pin with the Nox Battery Lid Key accompanying the Nox A1s System Kit or similar tool and slide the lid towards the bottom of the device.
  • Page 22 Nox A1s Manual Step 5 Attaching the Nox A1s 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 23: Attaching The Nox Nasal Cannula

     Note: The Nox nasal cannula with filter has a built-in hydrophobic filter and is the preferred way to measure nasal airflow and snoring as it is designed to maximize the signal quality and fits directly with the Nox A1s recorder. Step 1 Place the nasal prongs gently in the nostrils.

  • Page 24: Measuring Mask Pressure

    Nox A1s 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 A1s recorder via a filter tube connector from Nox Medical.
  • Page 25 Nox A1s Manual Connect the Nox A1s EEG Head Cable to the E2-E1, F4-F3, C4-C3, O2-O1, M2-M1 unipolar and ground inputs of the Nox A1s recorder. Place a snap-on electrode on the middle of the patient’s forehead. Route the Nox A1 EEG Head Cable behind the patient’s head and snap the cable to the electrode.

  • Page 26: Measuring Emg/Ecg Signals

    Nox A1s Manual using the customized Nox A1s 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 A1s Recorder.

  • Page 27: Measuring Pulse And Oxygen Saturation Using Nonin Wristox2 Pulse Oximeter, Model 3150 Ble

    Nox A1s Manual For submental EMG, insert the electrode leads into the EMG channels of the Nox A1s 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 28 Nox A1s Manual  Warning: To prevent improper performance and/or patient injury, verify compatibility of the Nox A1s recorder, oximeter, sensor(s), and accessories before use.  Warning: Before changing the batteries, make sure the oximeter is off and the sensor is not applied to a digit.

  • Page 29: Inserting Batteries Into The Nonin Wristox2 Pulse Oximeter, Model 3150 Ble

    The Nox A1s recorder can communicate with an auxiliary Bluetooth® pulse oximeter for recording of oxygen saturation levels (SpO ), pulse rate, and plethysmography data.
  • Page 30 Nox A1s Manual ● CD – ROM of the Operator’s 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 31: Establishing A Connection Between The Nonin 3150 Ble Pulse Oximeter And Nox A1S

    Ambulatory studies Before you can send out the Nox A1s recorder and accessories for an ambulatory recording, you need to make sure that a connection has been established between the Nox A1s recorder and the oximeter. The pairing of the Nox A1s recorder and the oximeter is done during the configuration of the device in the Noxturnal software.
  • Page 32 Nox A1s Manual Note: The Nox A1s recorder will only connect to Nonin 3150 BLE oximeters and does not support connecting to the Nonin 3150 Classic oximeters. Refer to the Nox Medical support page for further information. Pairing Process Step 1. Inserting Batteries Start by inserting fresh/fully charged batteries in the Nonin 3150 BLE pulse oximeter.
  • Page 33 Nox A1s Manual Step 3. Connect the Nox A1s recorder with a USB cable and follow the configuration in Noxturnal Fill in the BDA number of the pulse oximeter found on the back of the Nonin 3150 BLE oximeter ~ 33 ~...
  • Page 34 Nox A1s Manual Click Pair with Oximeter and the pairing will be performed either result in a successful pairing Or an unsuccessful paring If not successful follow the troubleshooting tip in the software or see the troubleshooting tips below Step 4. Bluetooth Wake up mode.
  • Page 35 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 A1s recorder starts a study (either manual start or scheduled start)
  • Page 36 Verify that the BDA number of the oximeter used matches the number used to configure the Nox A1s Recorder. The BDA number used in configuration of the Nox A1s 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 37 Reboot the Nox A1s recorder by simply waiting for the Nox A1s to turn off (it turns off automatically in 2 minutes after it has been turned on) and then, turn on the Nox A1s again by pushing the button or removing and re-inserting the battery.

  • Page 38: Maintenance

    No regular testing of the Nox A1s recorder or accessories, including patient cables, is needed. The service life of the Nox A1s recorder and Nox A1s 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 39 The Nox A1s recorder is factory calibrated. No further calibration is needed. Cleaning of Nox A1s Recorder and its Accessories  Warning: The Nox A1s 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 40 Nox A1s Manual Nox A1s Recorder, Nox Snap On Double Leads, Nox USBc Cable, Nox Abdomen Cable, Nox A1 EEG Head Cable, Nox A1s Carry Case: ATERIALS EQUIPMENT ● Endozime® AW Plus or equivalent validated hospital cleaner** ● Lint-free cloths ●...
  • Page 41 ** Aniosurf ND Premium is a validated hospital cleaner and recommended to use with the Nox Sleep System. *** 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 42 Nox A1s Manual Disposal Follow local governing ordinances and recycling instructions regarding disposal or recycling of this device and accessories, including batteries.  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.

  • Page 43: Compatible Sensors And Devices

    The following table includes information on accessories, sensors and devices that have been validated with the Nox A1s recorder. The items listed below are Nox products and have been validated for use with the Nox A1s recorder: NOX DISPOSABLE RIP BELTS...
  • Page 44 Nox Snap On Double-Lead 50/52 cm, white, keyhole connector, 1 unit 554316 Nox Snap On Double-Lead 30/32 cm, beige-white, keyhole connector, 1 unit 554317 The items listed below are 3 party products and have been validated for use with the Nox A1s recorder: PULSE OXIMETERS Type Catalogue Number Nonin WristOx...
  • Page 45 Nox A1s Manual NONIN WristOx Flex Sensor with 25 Flexi Wraps, 30 cm (12 in) cable – Adult 553130 NONIN WristOx Wrist Band 564042 WristOx Wrist Band, Disposable 560450 THERMAL FLOW SENSORS Type Catalogue Number Thermal Flow Sensor – Adult (S.L.P. Limited)
  • Page 46 Nox A1s Manual CLEANING Type Catalogue Number Super Sani-Cloth Plus Disinfection Wipes 559010 Sani-Cloth AF Universal - Alcohol free Disinfection wipes from PDI 559011 ~ 46 ~...

  • Page 47: Specifications

    Nox A1s Manual Specifications Nox A1s and Accessories DESCRIPTION PROPERTIES FUNCTION  Nox A1s Storage Capacity 4GByte  Nox A1s Recording Time 10 hours  Nox A1s Internal Channels Two RIP Respiratory Effort  Pressure  Respiratory sound/snoring  Four bipolar ...
  • Page 48 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 A1s Power Source One 1.5 V AA battery  Host PC (data configuration and download) ...

  • Page 49: Material Information

    Nox A1s Manual  2 MHz Bandwidth Nox A1s STORAGE FREQUENCY  8 kHz Microphone  3 Hz SpO2 Pleth  75 Hz Nox A1s SAMPLING FREQUENCY  1 MHz Microphone  75 Hz SpO2 BANDWIDTH  Internal 3.5 kHz bandwidth...

  • Page 50: Nox A1S Battery Information

     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 A1s study: ● Lithium batteries and Powerex 2700 mAh rechargeable batteries should be used to record a minimum of 10 hours.

  • Page 51: Regulatory Information

    Nox Sleep System. Furthermore, use of other sensors or accessories with the Nox A1s recorder invalidates the Declaration of Conformity issued by Nox Medical towards the Medical Devices Directive 93/42/EEC (MDD). Use of other components than verified, validated or recommended by Nox Medical with the Nox A1s recorder is considered to be a modification of the Nox Sleep System.

  • Page 52: Description Of Symbols And Labels

    Nox A1s 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  Catalogue number / Reference number ...
  • Page 53 Nox A1s Manual  Disposing of this product correctly will help save valuable resources and prevent any potential negative effects on human health and the environment, which could otherwise arise from inappropriate waste handling.  Non-ionizing radiation. Equipment includes RF...

  • Page 54: Bluetooth® Wireless Technology

    Radio Frequency (RF) specifications for the Nox A1s recorder. 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 55 Electromagnetic disturbances - Requirements and Tests. ELECTROMAGNETIC EMISSIONS The Nox A1s 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 56 Nox A1s Manual ELECTROMAGNETIC IMMUNITY The A1s 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 57 Nox A1s Manual The A1s 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. Maximum Immunity Test Frequency Band Distance...

  • Page 58: About

    (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. PDF readers are commonly available at no cost for users.

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