Nox Medical A1 User manual

MANUAL
Copyright 2016 Nox Medical

Nox A1 Manual
Version 2.0
Latest Revision: May 2016
Copyright © 2016
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 device software 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.

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Table of Contents
Table of Contents .....................................................................................................................................3
Introduction..............................................................................................................................................5
Scope ...................................................................................................................................................5
Instructions for Operators ...................................................................................................................5
Warnings and Cautions for Use ...........................................................................................................5
Device Description....................................................................................................................................9
Intended Use........................................................................................................................................9
Contraindications.................................................................................................................................9
A1 Interface .......................................................................................................................................10
Operating the Device.............................................................................................................................. 12
Connecting the A1 Device to a Computer..........................................................................................12
Configuring and Downloading from A1 Device..................................................................................12
Manually Starting/Stopping a Recording...........................................................................................13
Starting a Recording at a Scheduled Time .........................................................................................14
Signal and Status Checks....................................................................................................................14
Patient Hookup.......................................................................................................................................15
Inserting a Battery to the A1 Device..................................................................................................15
Attaching the A1 Device and the RIP Belts ........................................................................................16
Attaching the Nasal Cannula..............................................................................................................18
Measuring EEG Signals.......................................................................................................................19
Measuring EMG/ECG Signals .............................................................................................................21
Measuring Mask Pressure..................................................................................................................22
Measuring Data from Auxiliary Devices.............................................................................................23
Measuring Pulse and Oxygen Saturation...........................................................................................23
Inserting Batteries into the Oximeter ................................................................................................24
Selecting Oximeter Sensor Size..........................................................................................................25
Attaching the Pulse Oximeter Module and Sensor............................................................................26
Configuring the Oximeter Setup........................................................................................................27

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Maintenance...........................................................................................................................................28
Compatible Sensors and Devices............................................................................................................31
Specifications..........................................................................................................................................36
A1 Device ...........................................................................................................................................36
Material Information ......................................................................................................................... 38
Battery Information ...........................................................................................................................39
Regulatory Information ..........................................................................................................................40
Performance Testing and Validation Summary .................................................................................40
Classifications.....................................................................................................................................40
Description of Symbols and Abbreviations........................................................................................40
Bluetooth® Wireless Technology.......................................................................................................43
EMC Information................................................................................................................................43
About......................................................................................................................................................49

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Introduction
Congratulations on choosing the Nox A1 PSG recorder. The A1 is an AASM (American Academy of
Sleep Medicine) compliant PSG recorder and can be used for online and ambulatory sleep testing
polysomnography (PSG). The device is compact, lightweight and easy to use. Simple sensor placement
makes setup quick and easy.
Scope
This manual covers the A1 device and its components along with external sensors and devices that
have been validated with the A1 system. It does not cover the software application needed for device
configuration, data download, review and/or analysis.
This manual is only intended for professionals (healthcare professionals and service personnel) with
relevant qualifications and skills.
Instructions for Operators
The A1 system 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 A1 device
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 representatives
for assistance, if needed, in setting up and attaching the A1 device, its components and
external sensors and devices that have been validated with the A1 system, operating or
maintaining the device; or
to report unexpected operation or events.
Support information and information about Nox Medical’s representative can be found on Nox
Medical’s website: www.noxmedical.com/distributors.
Warnings and Cautions for Use
Warning: The A1 device 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: This device 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

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equipment needs special precautions regarding 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 this device and
cause injuries to the operator/patient.
Warning: The A1 device should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the A1 device should be observed to verify normal
operation in the configuration in which it will be used and prevent abnormal operation which
might cause injuries to the operator/patient.
Warning: This system may be interfered with by other equipment, even if that equipment
complies with CISPR emission requirements, causing possible patient harm.
Caution: The A1 device is designed to be safe for use for pacemaker patients as long as the
pacemakers comply with the EN 50061 standard of electrical safety of medical devices. Using
non-compliant pacemakers may result in the operation of the pacemaker being affected by
the use of A1 device and lead to possible recoverable patient harm. 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 A1 device 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 recoverable 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 A1 device is not intended to be used with high frequency (HF) equipment.
Using the A1 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 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 recoverable
patient harm.
Warning: The A1 device is 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: Only use United States Environmental Protection Agency (EPA) registered products
for cleaning/disinfection of the A1 device to prevent harm to the operator/patient.
Warning: The device 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 A1 System 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 A1 system, including patient cables and electrodes, in an
MRI (Magnetic Resonance Imaging) environment. The energy absorption in conductive
materials might lead to excessive heating and cause burns.
Caution: The A1 device and RIP belts should be worn over clothing to prevent allergic

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reaction to the equipment materials.
Caution: The RIP belts should fit the patient snugly without being uncomfortably tight to
avoid discomfort.
Warning: The Nox disposable RIP belts are single use. Re-using the disposable RIP belts may
affect the quality of recorded signals and lead to possible incorrect treatment.
Warning: The Nox disposable RIP belts, Nox 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 device or patient/operator injury.
Warning: The A1 device and its accessories should be removed from the patient before use
of the USB connector to prevent electric shock. The USB connector shall only be used for the
purposes of configuring the device and downloading data from the device.
Warning: There are no user serviceable parts inside the A1 device. The A1 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 A1 device
is opened.
Warning: No modification of this equipment is allowed. Un-authorized modifications could
result in the device not performing as intended and cause serious harm to the patient.
Warning: Remove batteries from the A1 device if the device 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 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 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: 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 cross-infection between

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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 device should always be transported in its 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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Device Description
The Nox A1 device is an AASM compliant PSG recorder.
The A1 input channels and built-in capabilities include the following:
13 unipolar channels; for recording of EEG, EOG and submental EMG
1 ground channel
4 bipolar channels; for recording of ECG, EMG –LM, 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 effort
3-D built-in acceleration sensor; for recording of patient’s position and activity
Built-in microphone; for recording of audio and snoring
Built-in Bluetooth® module; to support wireless connectivity allowing it to record signals
from compatible auxiliary devices
The Bluetooth® function also allows wireless streaming of data for online review of signals.
The device is powered with one AA battery.
Intended Use
The Nox A1 device is intended for ambulatory and online recording of physiological signals during
sleep. The recorded signals are either downloaded after the study or streamed wirelessly over
Bluetooth® entry points/Nox C1 Access Point during the study to a PC where the signals can be
viewed and analyzed by use of the Noxturnal application. The A1 recorder is also capable of
communicating over Bluetooth® via the Nox C1 access point for the purpose of device control. The A1
recorder is finally capable of communicating over Bluetooth® with the Nox app running on a mobile
platform for the purpose of device control and review of signals.
The A1 system is intended for patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test
environments, including patient’s home.
Contraindications
The A1 device is NOT intended for any patient monitoring or automatic diagnosis.

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A1 Interface
The A1 device 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.
NUMBER
FUNCTION
1
Display
2
Push button –Middle
3
Push button –Forward
4
Push button –Backward
5
Clip strap loops
6
Microphone –For recording of respiratory sounds
7
Indicator light for device status
8
Pressure lock –Connects to nasal cannula/mask pressure tube
9
Unipolar touch proof inputs
10
Reference ground input
11
Bipolar touch proof inputs
12
Battery lid –Covers the battery and the USB connector

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13
Battery lid pin
14
Metal snaps –Connects to thorax RIP belt
15
Metal snaps –Connects to abdomen cable

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Operating the Device
The A1 system 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 A1 device 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 A1 device 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 the A1 Device to a Computer
Warning: The A1 device and its accessories should be removed from the patient
before use of the USB connector to prevent electric shock. The USB connector
shall only be used for the purposes of configuring the device and downloading
data from the device.
To connect an A1 device 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 a pen or a similar tool, available from Nox Medical, on the battery lid
pin and slide the battery lid down, towards the bottom of the device. The A1 device connects to the
computer by using a mini USB cable. The battery does not have to be inserted while the device is
connected to the computer.
When the A1 device is connected to the computer the device display lights up.
Configuring and Downloading from A1 Device
To download a recording or configure the A1 device you will need to start the Noxturnal software
application and connect the device to the computer. Please refer to the applicable software user
manual for more information on how to perform those tasks.
When you are done working with the device eject the device from the Noxturnal software and unplug
the 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 a Recording
If the device 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 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 a Recording at a Scheduled Time
If the device 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.
Signal and Status Checks
The indicator light on the device 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 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 3
minutes.
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.
2. Duration being displayed.
For detailed signal checks, please refer to the Noxturnal App, available on the Google Play® store.

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Patient Hookup
The A1 system is only intended to be hooked-up by professionals (healthcare professionals and
service personnel) with relevant qualifications and skills.
Warning: Do not use damaged equipment, sensors or accessories. This may result
in bad performance of the device 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 device should always be transported in its accompanying carrying
case to ensure adequate protection and prevent damage.
Inserting a Battery to the A1 Device
Note: Always use fully charged Powerex 2700 mAh Rechargeable Batteries or
fresh lithium battery for each sleep recording to prevent the need for the sleep
study to be repeated.
Note: All lithium batteries used with the A1 device shall be according to the
standard IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries.
Before you start a recording you should make sure that the device has a new or fully charged battery.
To insert a new battery do the following:
1. Open the battery compartment by pressing down the battery lid pin with the Nox Lid Key or
similar tool and slide the lid towards the bottom of the device.
2. 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).
3. 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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Attaching the A1 Device and the RIP Belts
Caution: The A1 device and RIP belts should be worn over clothing to prevent
allergic reaction to the equipment materials.
Warning: The disposable RIP belts are single use and 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 on more than
one patient poses a risk of cross-infection.
Step 1
Snap the clips that are attached to the device to the patient’s shirt.
1
Step 2 to Step 4
Snap the abdomen cable to the back of the device.
Place a RIP belt around the thorax and snap its ends to the back panel of the device.
Adjust the cable length as needed by wrapping it around the abdomen connection unit. Place
a RIP belt around the abdomen and snap it in place.
2
3
4

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Step 5
Attaching the device and respiratory sensors is now completed.
5
Adjusting the RIP Belts
Caution: The RIP belts should fit the patient snugly without being uncomfortably
tight to avoid discomfort.
Disposable RIP Belts
Fit the 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.
Refer to the “Compatible Sensors and Devices” section regarding the types of Nox RIP belts that have
been validated with the A1 device.
NOTE: For most patients the 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 the product for more detailed instructions.

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Attaching the Nasal Cannula
Warning: The nasal cannula is 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.
Step 1
Place the nasal prongs gently in the nostrils. The prongs should point downwards inside the nostrils.
1
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
2
3
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 A1 device. 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 A1 device.
Refer to the “Compatible Sensors and Devices”section regarding the types of nasal cannulas that
have been validated with the A1 device.

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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 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.
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 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 recoverable patient harm.
Note: The Nox EEG Head Cable is available in both pediatric and adult lengths.
Connect the Nox EEG Head Cable to the E2-E1, F4-F3, C4-C3, O2-O1, M2-M1 unipolar and ground
inputs of the A1 device.

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Place a snap-on electrode on the middle of the patient’s forehead. Route the head cable behind the
patients head and snap the cable to the electrode.
Connect two Nox 5 Lead EEG Electrode Cables to the head cable, one on each side.
Attach the gold cup electrodes to the patient’s head. The green wire is for E1/E2, the blue wire is for
F3/F4, the yellow wire is for C3/C4, the grey wire is for O1/O2 and the red wire is for M1/M2.