Nox Medical

nox A1 Manual Ver 2.1 March 2017

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Manual

Nox A1 Manual Version 2.1 Latest Revision: March 2017 Copyright © 2017 Nox Medical - All rights reserved Manufactured by: Nox Medical ehf Katrinartuni 2 IS - 105 Reykjavik Iceland Website: www.noxmedical.com

For distributor information go to: www.noxmedical.com

Copyright Notice 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. Disclaimer This document may contain typographical errors or technical inaccuracies. Nox Medical does not accept any liability for the use or misuse whether direct or indirect of the products, or for damages arising out of the use of or inability to use the products. 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. License Notice The Nox A1 recorder’s firmware contains BIGDIGITS multiple-precision arithmetic code originally written by David Ireland, copyright © 2001-8 by D.I. Management Services Pty Limited <www.di-mgt.com.au>, and is used with permission.

Nox A1 Manual

Table of Contents Table of Contents ... 3 List of Abbreviations ... 5 Introduction ... 7 Intended Use... 7 Contraindications ... 7 Scope ... 7 Instructions for Operators ... 8 Warnings and Cautions for Use ... 8 Nox A1 Description ... 11 Nox A1 Interface ... 11 Operating Nox A1 ... 13 Connecting Nox A1 to a Computer ... 13 Configuring and Downloading from Nox A1 ... 13 Manually Starting/Stopping Nox A1 ... 14 Starting Nox A1 at a Scheduled Time ... 15 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 ... 20 Measuring EMG/ECG Signals ... 22 Measuring Data from Auxiliary Devices ... 24 Measuring Pulse and Oxygen Saturation using Nonin 3150 Pulse Oximeter ... 24 Inserting Batteries into the Nonin 3150 Pulse Oximeter ... 25 Selecting Oximeter Sensor Size... 26 Attaching the Nonin 3150 Pulse Oximeter and Soft Sensor ... 26

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Nox A1 Manual 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 ... 41 Description of Symbols and Labels ... 41 Bluetooth® Wireless Technology ... 44 Electromagnetic Compatibility (EMC) Information... 44 About ... 50

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List of Abbreviations AASM

American Academy of Sleep Medicine

ABS

Acrylonitrile Butadiene Styrene

BMI

Body Mass Index

CISPR

Comité International Spécial des Perturbations Radioélectriques (English: International Special Committee on Radio Interference)

CMDR

Canada Medical Device Regulations

ECG

Electrocardiography

EEG

Electroencephalography

EMG

Electromyography

EMC

Electromagnetic compatibility

EOG

Electrooculography

ESD

Electrostatic discharges

FCC

Federal Communications Commission

FDA

Food and Drug Administration

High Frequency

IEC

International Electrotechnical Commission

ISM

Industrial, Scientific and Medical

MDD

Medical Device Directive

MRI

Magnetic Resonance Imaging

NiMH

Nickel-metal hydride battery rechargeable

PAP

Positive Airway Pressure

Polycarbonate

PET

Polyethylene Terephthalate

Polyethylene

PSG

Polysomnography

PVC

Polyvinyl Chloride

R&TTE

Radio and Telecommunication Terminal Equipment

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Radio Frequency

RIP

Respiratory Inductance Plethysmography

SpO2

Oxygen Saturation Levels measured by pulse oximetry

TPE

Thermoplastic Elastomer

WEEE

Europe on Waste of Electrical and Electronic Equipment

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Nox A1 Manual

Introduction Congratulations on choosing the Nox A1 recorder. The Nox A1 recorder is an American Academy of Sleep Medicine (AASM) compliant body worn sleep recorder and 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 A1 recorder has a built-in Bluetooth® module also allowing it to record signals from compatible auxiliary devices. Placement of the recorder and connecting sensors is simple and makes the setup quick and easy. The Nox A1 recorder is configured by the Noxturnal software from Nox Medical, running on a PC, that also allows for the review, organization, analyzing, and summarizing of all signals recorded by the device. The complexity of the study is defined by varying the number and types of physiological signals measured, supporting both ambulatory and online sleep testing. During online configuration of the Nox Sleep System, commands and data are sent between the Nox A1 recorder and the Noxturnal software by use of the Nox C1 Access Point from Nox Medical. The Nox A1 recorder can communicate over Bluetooth link, either direct or via the Nox C1 Access Point (depending on the system configuration), with Noxturnal App from Nox Medical running on a mobile platform for device control and online review of signals being recorded.

Intended Use The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake in patients greater than 2 years of age. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient’s home.

Contraindications The Nox Sleep System does not provide any alarms and is not intended to be used for continuous monitoring where failure to operate can cause injuries or death of the patient.

Scope This manual covers the use of the Nox A1 recorder and its components along with external sensors and auxiliary devices that have been validated with the 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: • •

Noxturnal Manual Nox C1 Manual

This manual is only intended for professionals (healthcare professionals and service personnel) with relevant qualifications and skills. Additional material can be found on the Nox Medical Website.

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Nox A1 Manual

Instructions for Operators The Nox A1 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 the Device”, “Patient Hookup” and “Maintenance” sections. The ONLY operation that patients might have to perform by themselves at home is to start recordings that have been configured to be manually started. In that case, the professional setting up the Nox A1 recorder and hooking up the patient shall demonstrate how to start the recording manually and train the patient to do so according to the “Manually Starting/Stopping a Recording” section. Operators should contact Nox Medical or its sales representatives •

•

for assistance, if needed, in setting up, attaching, operating or maintaining the Nox Sleep System, its accessories, and as applicable external sensors and auxiliary devices that have been validated with the system; or to report unexpected operation or events.

Support information and information about Nox Medical’s sales representative can be found on Nox Medical’s website: www.noxmedical.com/distributors.

Warnings and Cautions for Use  Warning: The Nox Sleep 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.  Caution: The Nox A1 recorder complies with the international standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. That standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of interference due to close proximity or strength of source might disrupt the performance of the device, affecting recorded signals and therefore data analysis and resulting in possible incorrect treatment. Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in the “EMC Information” section of this manual.  Warning: The use of accessories, transducers, sensors, and cables other than those listed in this manual may result in increased emissions and/or decreased immunity of the 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 in the configuration in which it/they will be used and prevent abnormal operation which might cause injuries to the operator/patient.  Warning: The Nox Sleep System may be interfered with by other equipment, even if that equipment complies with 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.

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

 

  

 

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.. Warning: The Nox A1 recorder is not defibrillator proof. Not removing the device from a patient before defibrillation may lead to the creation of high current density at the electrode sites, causing burns and leading to possible patient harm. Not removing the device from a patient before defibrillation may also alter the intended flow of the current, affecting the defibrillation efficiency and causing injuries or death of the patient. Warning: The Nox A1 recorder and is accessories are not intended to be used with high frequency (HF) equipment. Using the device with high frequency (HF) equipment could cause potential serious harm to the patient. Warning: The Nox EEG Head Cable/Nox 5 Lead EEG Cables do not provide protection against the effect of the discharge of a cardiac defibrillator nor against high frequency burns. Not removing the equipment from a patient before defibrillation may lead to the creation of high current density at the electrode sites, causing burns and leading to possible patient harm. Warning: The Nox A1 recorder and accessories are not designed to give a specified degree of protection against harmful ingress of liquids. Do not autoclave or immerse the device in any kind of liquids. Ingress of liquids may result in electric shock. Warning: In the United States of America, only use United States Environmental Protection Agency (EPA) registered products for cleaning/disinfection of the Nox A1 recorder and accessories to prevent harm to the operator/patient. Warning: The Nox A1 recorder is NOT suitable for use in presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. That could lead to the creation of electrostatic charges or temperature exceeding limits resulting in sparks or ignition, causing burns or explosions. Warning: Do not use the Nox A1 recorder and accessories during radiography/X-ray studies. The energy absorption in the device, cables or electrodes might lead to excessive heating and cause burns. Warning: As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation. Warning: Do not use any part of the Nox Sleep System, including patient cables and electrodes, in a MRI (Magnetic Resonance Imaging) environment. The energy absorption in conductive materials might lead to excessive heating and cause burns. Caution: The Nox A1 recorder and RIP belts should be worn over clothing to prevent allergic reaction to the equipment materials. Caution: The Nox RIP belts should fit the patient snugly without being uncomfortably tight to avoid discomfort. Warning: The Nox disposable RIP belts, Nox nasal cannulas, Nox filter tube connectors and mask pressure tubes are single patient use. Re-using the disposable RIP belts may affect the quality of recorded signals and lead to possible incorrect treatment. Using the same disposable RIP belt, cannula, filter tube connector and mask pressure tube on more than one patient poses a risk of cross-infection. Warning: Do not use damaged equipment, sensors, or accessories. This may result in bad performance of the Nox Sleep System or patient/operator injury. Warning: The Nox A1 recorder and its accessories should be removed from the patient before use of the USB connector to prevent electrical shock. The USB connector shall only be

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Nox A1 Manual used for the purposes of configuring the device and downloading data from the device.  Warning: There are no user serviceable parts inside the Nox A1 recorder. The device should be serviced by authorized parties only. Service performed by non-authorized parties may affect data analysis and result in possible incorrect treatment. The warranty is void if the Nox A1 recorder is opened (except for opening of the battery compartment).  Warning: No modification of the Nox A1 recorder and its accessories is allowed. Unauthorized modifications could result in the device not performing as intended and cause serious harm to the patient. To ensure patient safety and effective use of the Nox Sleep 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.  Warning: External equipment and all auxiliary devices intended for connection to signal input, signal output or other connectors shall comply with the relevant product safety standards, e.g. IEC 60950-1 for IT equipment and the IEC 60601 series for medical electrical equipment, to prevent electric shocks. In addition, all such combinations – systems – shall comply with the safety requirements stated in the collateral standard IEC 60601-1-1 or the general standard IEC 60601-1, edition 3/3.1, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support. Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative.  Warning: Avoid accidental contact between connected but unused patient applied parts and other conductive parts including those connected to protective earth to prevent potential serious harm to the operator/patient.  Warning: Make sure the conductive parts of electrodes and associated connectors, including the neutral electrode, do not contact other conductive parts including earth to prevent potential serious harm to the operator/patient.  Warning: Electrodes should only be used by or in consultation with a healthcare provider familiar with their proper placement and use. Not using and placing the electrodes correctly may affect recording of data, and therefore interpretation and diagnostics.  Warning: The electrodes should be applied only to intact, clean skin (e.g. not over open wounds, lesions, infected or inflamed areas) to prevent infections.  Warning: The Nox 5 Lead EEG Electrode Cables should be properly disposed of if they cannot be fully cleaned between uses to prevent the risk of cross-infection between patients.  Warning: The Nox 5 Lead EEG Electrode Cables are not certified to be used for electrical stimulation purposes. 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.  Please read this manual carefully before use, especially sections marked with an exclamation mark.

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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) 1 ground channel 4 bipolar channels; for recording of electrocardiogram (ECG), periodic limb movements (PLM), bruxism, or additional EMG 1 pressure/cannula channel; for recording of nasal or mask pressure 2 respiratory effort channels; for recording of abdomen and thorax ventilatory effort signals 3-D built-in acceleration sensor; for recording of patient’s position and activity Built-in light sensor; for recording of ambient light Built-in microphone; for recording of audio and snoring Built-in Bluetooth® module; to support wireless connectivity allowing the device to record signals from compatible auxiliary devices

During online configuration of the Nox Sleep System the Bluetooth function enables the Nox A1 recorder to communicate with the Noxturnal software and the Noxturnal App via the Nox C1 access point for device control and online review of recorded signals. During ambulatory configuration of the Nox Sleep System, the Bluetooth function enables the Nox A1 recorder to communicate with Noxturnal App for device control and online review of recorded signals. The Nox A1 recorder is powered with one AA battery.

Nox A1 Interface The Nox A1 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. See the figures and tables below for detailed description.

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NUMBER

FUNCTION

INPUT/SENSOR LABEL

Display

2 3

Push button – Middle Push button – Forward

White square White arrow pointing right

Push button – Backward

White arrow pointing left

2 Clip strap loops

Microphone – For recording of respiratory sounds

Light sensor located under the shaded transparent microphone cover

Indicator light for device status

1 Pressure lock – Connects to nasal cannula/mask pressure tube

PRES: Pressure input connector

13 Unipolar touch proof inputs

• •

EMG: 1,2, F – Electromyography (EMG) input connectors E2-E1, F4-F3, C4-C3, O2-O1, M2-M1: Electroencephalography (EEG) and electrooculography (EOG) input connectors

1 Reference ground input

•

PGND: Patient ground

4 Bipolar touch proof inputs

•

GP1: General purpose bipolar input connector ECG: Electrocardiography (ECG) input connectors LM1, LM2: Electromyography (EMG) input connectors

• • 12

Battery lid – Covers the battery and the USB connector Battery lid pin

2 Metal snaps – Connects to thorax RIP belt

2 Metal snaps – Connects to abdomen cable

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Nox A1 Manual

Operating Nox A1 The Nox A1 recorder is only intended to be operated by professionals (healthcare professionals and service personnel) with relevant qualifications and skills. The ONLY operation that patients might have to perform by themselves at home is to start recordings that have been configured to be manually started. In that case, the professional setting up the Nox A1 recorder and hooking up the patient shall demonstrate how to start the recording manually and train the patient to do so according to the “Manually Starting/Stopping a Recording” section. The Nox A1 recorder is operated with three push buttons located on the front panel. Pressing the Middle button turns on the display. The display will automatically turn off in 3 minutes.

Connecting Nox A1 to a Computer  Warning: The Nox A1 recorder and its accessories should be removed from the patient before use of the USB connector to prevent electrical shock. The USB connector shall only be used for the purposes of configuring the device and downloading data from the device. To connect Nox A1 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 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. The battery does not have to be inserted while the device is connected to the computer.

When the Nox A1 recorder is connected to the computer the device display lights up and a message saying the device is connected to the computer.

Configuring and Downloading from Nox A1 To download a recording or configure the Nox A1 recorder you will need to start the Noxturnal software application and connect the device to the computer. Please refer to the Noxturnal manual for more information on how to perform those tasks. When you are done working with the device eject it from the Noxturnal software and unplug the Nox mini USB cable. Insert the battery and close the battery compartment by pressing the lid back towards the device without causing any strain, then slide it back into position, towards the top of the device.

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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”. Please do so until you see “Recording Duration” displayed. Note the Middle button needs to be pressed down for approximately 4-5 s before “Recording Duration” displays. At this point the device has started to record data. After the display turns off, the light on the top right side of the display will blink green intermittently indicating that recording is taking place. Use the same method to manually stop the recording.

If the duration of the recording has been specified during configuration, the recording will automatically stop after the specified duration.

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Starting Nox A1 at a Scheduled Time If the Nox A1 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 Middle button before the recording has started will display a countdown to the specified start time of the recording. If the recording has begun, the display shows the current duration of the recording.

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. Warnings might include: •

Battery low

Information about the recording duration and the device is shown on the display. If the display is turned off, pressing the 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. 3 1 1.

On the top right corner is a battery indicator which shows the battery status. The battery indicator shows 100% when the device has fresh batteries.

Duration being displayed.

The device’s clock

For detailed signal checks, please refer to the Noxturnal App from Nox Medical, available on the Google Play® store.

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Nox A1 Patient Hookup  Warning: Do not use damaged equipment, sensors or accessories. This may result in bad performance of the Nox Sleep System or patient/operator injury.  Warning: As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation.  Caution: The Nox A1 recorder and its accessories should always be transported in its accompanying carrying case to ensure adequate protection and prevent damage. The Nox A1 recorder is only intended to be hooked-up by professionals (healthcare professionals and service personnel) with relevant qualifications and skills.

Inserting a Battery to the Nox A1  Note: Always use fully charged Powerex 2700 mAh Rechargeable Batteries or fresh lithium battery for each recording to prevent the need for the sleep study to be repeated.  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:

Open the battery compartment by pressing down the battery lid pin with the Nox Battery Lid Key accompanying the Nox A1 System Kit or similar tool and slide the lid towards the bottom of the device.

Place one AA battery in the compartment aligning the battery poles as illustrated on the back of the device (the positive (+) pole is towards the battery lid).

Close the battery compartment by pressing the lid back towards the device without causing any strain, then slide it back into position, towards the top of the device. Make sure the lid is securely closed.

The status of the battery can be checked by turning on the device. The battery status indicator positioned in the upper right-hand corner of the device display allows you to check the battery status. When the battery is running low during a recording the device will automatically stop the recording.

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Nox A1 Manual

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.  Warning: The Nox disposable RIP belts are single use and single patient use. Reusing the disposable RIP belts may affect the quality of recorded signals and lead to possible incorrect treatment. Using the same disposable RIP belt on more than one patient poses a risk of cross-infection.

Step 1 Snap the clips that are attached to the Nox A1 recorder to the patient’s shirt. 1

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. 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. 3

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Step 5 Attaching the Nox A1 recorder and Nox disposable RIP belts is now completed. 5

Adjusting the Nox RIP Belts  Caution: The Nox disposable RIP belts should fit the patient snugly without being uncomfortably tight to avoid discomfort.  Note: For most patients, the Nox disposable RIP belts do not need to be adjusted if the correct belt size is chosen based on the patient’s abdomen circumference and/or body mass index (BMI). Belt size selection tables accompany Nox disposable 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. The length is fixed with hooks on the plastic connector of the belt.

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Attaching the Nox Nasal Cannula  Warning: The Nox nasal cannulas are single patient use. Using the same nasal cannula on more than one patient poses a risk of cross-infection.  Note: Medical tape can be used to hold the cannula against the cheeks to secure the cannula in place if necessary.  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 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.

Step 1 Place the nasal prongs gently in the nostrils. The prongs should point downwards inside the nostrils.

Step 2 Pull the cannula tubing over the ears and then position it under the chin.

Step 3 Slide the fastener snugly under the chin to hold the cannula tubing securely in place. 1

Refer to the “Compatible Sensors and Devices” section regarding the types of Nox nasal cannulas that have been validated with the Nox A1 recorder.

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Measuring Mask Pressure  Warning: The mask pressure tubes and Nox filter tube connectors are single patient use. Using the same mask pressure tube and filter tube connector on more than one patient poses a risk of cross-infection.  Note: The mask pressure tube can only be connected to the pressure lock on the 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. Refer to the “Compatible Sensors and Devices” section regarding the types of mask pressure tubes that have been validated with the Nox A1 recorder.

Measuring EEG Signals  Warning: Electrodes should only be used by or in consultation with a healthcare provider familiar with their proper placement and use. Not using and placing the electrodes correctly may affect recording of data, and therefore interpretation and diagnostic.  Warning: The electrodes should be applied only to intact, clean skin (e.g. not over open wounds, lesions, infected or inflamed areas) in order to prevent infections.  Warning: Make sure the conductive parts of electrodes and associated connectors, including the neutral electrode, do not contact other conductive parts including earth to prevent potential serious harm to the operator/patient.  Warning: The Nox 5 Lead EEG Electrode Cables should be properly disposed of if they cannot be fully cleaned between uses in order to prevent the risk of crossinfection between patients.  Warning: The Nox 5 Lead EEG Electrode Cables are not certified to be used for electrical stimulation purposes. Using the product for electrical stimulation purposes might create burns and cause injuries to the patient.  Warning: The Nox EEG Head Cable/Nox 5 Lead EEG Cables do not provide protection against the effect of the discharge of a cardiac defibrillator nor against high frequency burns. Not removing the equipment from a patient before defibrillation may lead to the creation of high current density at the electrode sites, causing burns and leading to possible patient harm.  Note: The Nox EEG Head Cable is available in both pediatric and adult sizes.

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