Nox Medical C1 User manual

MANUAL

Nox C1 Manual
Version 1.5
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 C1 Access Point uses software components covered by open source licenses.
Licenses covering these software components are available on the Nox Medical
website:
www.noxmedical.com/products/nox-c1

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TABLE OF CONTENTS
Table of Contents............................................................................................................................ 3
Introduction .................................................................................................................................... 5
Intended Use.............................................................................................................................. 5
Contraindications ....................................................................................................................... 5
Scope.......................................................................................................................................... 5
Instructions for Operators.......................................................................................................... 5
Warnings and Cautions for Use.................................................................................................. 5
Nox C1 Description.......................................................................................................................... 8
Nox C1 Interface......................................................................................................................... 8
Operating Nox C1.......................................................................................................................... 11
Connect to DC Power ...............................................................................................................11
Nox C1 Status ...........................................................................................................................12
Nox C1 Analog Inputs ...............................................................................................................13
Nox C1 Differential Pressure Sensor ........................................................................................ 14
Nox C1 Serial Inputs ................................................................................................................. 14
Nox C1 Serial-over-USB Inputs .................................................................................................15
Nox C1 Ambient Light Sensor...................................................................................................16
Nox C1 Network Configuration..................................................................................................... 16
Default Factory Configuration.................................................................................................. 16
Factory Reset............................................................................................................................17
Nox C1 Access Point Setup............................................................................................................ 17
Nox Sleep System Network Overview......................................................................................17
Maintenance.................................................................................................................................19
Compatible Devices, Sensors and Accessories.............................................................................. 21
Specifications ................................................................................................................................23
Nox C1 Access Point and Power Supply ................................................................................... 23

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Regulatory Information................................................................................................................. 24
Performance Testing and Validation Summary........................................................................ 24
Nox C1 Classification ................................................................................................................25
Description of Symbols and Labels...........................................................................................25
Bluetooth® Wireless Technology .............................................................................................27
Electromagnetic Compatibility (EMC) Information.................................................................. 27
About ............................................................................................................................................33

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INTRODUCTION
Congratulations on choosing the Nox C1 Access Point. The Nox C1 is a part of the Nox Sleep
System and has the main function to measure, receive, and stream physiological signals during
online configuration of the Nox Sleep System. The Nox C1 is able of communicating with Nox
recording devices and Noxturnal App over Bluetooth® link and with the Noxturnal PC software
over Ethernet to allow configuration of the Nox recording devices and streaming of online data.
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 users 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 instructions for the Nox C1 Access Point, and how to setup and operate
the device. The Nox C1 Access Point is operated by the Noxturnal PC software. For instructions
on how to configure and operate the device from the Noxturnal software refer to the Noxturnal
manual. The Noxturnal software and detailed user instructions are provided in electronic form
at: support.noxmedical.com. For an online setup of the Nox Sleep System a Nox A1 recorder is
also needed. For instructions on how to set up for online recording please refer to:
•Noxturnal Manual
•Nox A1 Manual
Instructions for Operators
This manual is only intended for professionals (healthcare professionals and service personnel)
with relevant qualifications and skills.
Warnings and Cautions for Use
Warning: The Nox Sleep System is NOT certified 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

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licensed medical practitioner.
Caution: The Nox C1 access point 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: Electromagnetic Interference (EMI) can be picked up by the analog
channels of the Nox C1 access point, causing disturbed or altered signals to appear
in the Noxturnal software. This may affect data analysis and result in possible
incorrect treatment.
Warning: The use of accessories 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 C1 access points 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 emission requirements of the CISPR (Special
International Committee on Radio Interference) causing possible patient harm.
Warning: The Nox C1 Access Point 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: In the United States of America, only use United States Environmental
Protection Agency (EPA) registered products for cleaning of the Nox C1 access
point to prevent harm to the operator/patient.
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: There are no user serviceable parts inside the Nox C1 Access Point. 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 C1 access point is opened.
Warning: No modification of the Nox C1 access point is allowed. Un-authorized
modifications may affect data analysis and result in possible incorrect treatment.
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

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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 a qualified medical technician
or your local representative.
Caution: After connecting a new auxiliary signal to the Nox C1 connectors OR after
modifying the connection of the auxiliary signals OR after changing the mode of
the auxiliary devices signal output, always verify the correct setup by performing
an actual recording, making the auxiliary device create a known signal, and
monitoring the appearance and values measured in the Noxturnal software, in
order to prevent signals that would lead to incorrect interpretation and possible
incorrect treatment.
Warning: All the auxiliary devices connected to the Nox C1 access point should be
powered from a single power strip to ensure a common ground, avoid ground
potential difference skewing or disturbing the signals and thus prevent possible
incorrect treatment.
Warning: Only use power supply FRIWO MP115 Medical-7555M/12 with the Nox
C1 access point. The use of an incorrect power supply may result in electric shock
or cause the device to overheat, which may result in patient/operator harm.
Warning: The USB channels, serial channels, and analog channels on the Nox C1
access point are signal input/output (SIP/SOP) auxiliary ports NOT TO BE
CONNECTED IN DIRECT GALVANIC CONNECTION to the patient. This may result in
electric shock.
Please read the user instructions carefully before initial use, especially sections
marked with an exclamation mark.

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NOX C1 DESCRIPTION
The Nox C1 is a Bluetooth® access point. It receives Bluetooth data stream from a Nox recording
device, has input ports for receiving of signals originating from various auxiliary devices and
internal sensors for ambient light measurement and pneumotachography. The
measured/received signals are processed within the Nox C1 access point before they are
streamed forward to the Noxturnal software over Ethernet.
The Nox C1 channels and built-in capabilities include the following:
•12 analog channels; for recording of DC signals from auxiliary devices
•2 USB channels
*
•2 serial channels; for recording of serial signals from auxiliary devices
•2 pressure sensor channels; e.g. for recording of patient airflow at the proximal airway
when using a CPAP device
•Built-in ambient light sensor
•Built-in Bluetooth® module; to support wireless connectivity allowing the device to
receive signals from the Nox A1 recorder
The Nox C1 is also equipped with an Ethernet input; to support connection of the device to an
Ethernet network for streaming of data and commands between the device and a remote
computer.
Furthermore, the Nox C1 communicates with the Nox recording device and Noxturnal App over
Bluetooth link and with the Noxturnal PC software over Ethernet to allow configuration of the
Nox recording devices and streaming of data.
The Nox C1 access point is powered by a medical grade power supply providing medical grade
isolation from mains.
Nox C1 Interface
The Nox C1 access point interface consists of an indicator light (LED) for device status, ambient
light sensor, analog channel inputs, Ethernet cable input, factory reset button, USB input*, serial
inputs, differential pressure sensor inputs and power supply connector.
The figure below shows the top view of the Nox C1, showing the device’s status LED (1) and the
ambient light sensor (2). For device status indicated with the LED, refer to the “Device Status”
section.
*
Currently the USB ports do not have any function

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The figure below shows the front view of the Nox C1, showing the six analog inputs, labelled DC
IN 1-12.
3
2
1

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The figure below shows the rear of the Nox C1, showing the six inputs available. Refer to the
table below for input definition.
The following table lists the Nox C1 access point inputs and the corresponding input labeling.
NUMBER
FUNCTION
INPUT/SENSOR LABEL
1
Indicator light for device status
No label on device
2
Ambient light sensor
No label on device
3
Analog inputs
DC IN 1-12
4
Ethernet cable input
LAN
5
Factory reset button
No label on device
6
USB inputs*
USB
7
Serial inputs
1 COM 2
8
Differential pressure sensor
inputs
+ PRES -
9
DC power supply connector
*
Currently the USB ports do not have any function
9
8
7
6
5
4

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OPERATING NOX C1
The Nox C1 Access Point is only intended to be operated by professionals (healthcare
professionals and service personnel) with relevant qualification in hospitals, institutions, sleep
centers, sleep clinics or other test environment, not including the patient’s home.
Connect to DC Power
Warning: Only use power supply FRIWO MP115 Medical-7555M/12 with the
Nox C1 access point. The use of an incorrect power supply may result in
electric shock or cause the device to overheat, which may result in
patient/operator harm.
The Nox C1 is powered by FRIWO MP115 Medical-7555M/12, a specific medical grade power
supply rated with operating voltage of 12 volts and providing medical grade isolation from
mains. Connect the power supply into the DC power connector on the rear of the device and
have the applicable regional adapter connected to the power supply.
Verify that the LED indicator light on top of the Nox C1 access point starts blinking amber
immediately after connection of the power supply and starts blinking green when the startup
sequence of the device is completed and the Nox C1 is available for configuration.
FRIWO MP115 Medical-7555M/12 (FW7555M/12)
The medical grade power supply FRIWO MP115 Medical-7555M/12 is the only power supply that
should be used with the Nox C1 access point to ensure safe and effective device operation. The
LED indicator is the operating indicator. For detailed user instructions, product specifications and
regulatory information please refer to the Nox Medical web page.
Caution: In the case of visible damages on the housing or on the cord do not
use the power supply.
Warning: The device should never be operated or even stored at places listed
below, because this could lead to operating failures:
oPlaces, which are heavily exposed to moisture or where water

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condensing may occur
oPlaces, which are exposed to special environmental conditions
oPlaces, which are subject to constant vibrations
oPlaces, which are subject to high temperature fluctuations
oOutdoors
Caution: Always disconnect the power supply from mains during lighting
storms or when not in use.
Caution: The power supply itself is the disconnect device. Never use the cord
to pull the power supply from the mains.
Warning: The power supply is maintenance free. It must not be opened. (Risk
of electrical shock).
Warning: A modification of the power supply is not allowed.
Warning: The device may only be repaired by authorized personnel.
Warning: Remove from mains before cleaning. Do not clean with detergents.
Clean only with a dry cloth.
NOTE: The power supply unit is intended for supplying end medical product
by its output voltage.
Warning: The unit shall not be used for use in an oxygen rich environment.
Warning: The unit it is not intended to be used with flammable anesthetics
and not intended for use in conjunction with flammable agents.
Nox C1 Status
The Nox C1 access point has a built-in LED for device status indication. The LED is located on the
top panel of the device. Refer to the table below for a description of the different states of the
Nox C1 indicated with the LED.
Status Light Description
Off
Nox C1 is not connected to power and is turned off
Blinking amber
Nox C1 is connected to power and is completing the startup
sequence
Blinking green
Nox C1 is connected to power and ready to use. A recording is
not running
Solid green
A recording is running
Solid amber
Firmware error indication, Nox C1 is not functional
Nox C1 should be factory reset (refer to section “Factory Reset”)
Alternating green and
amber
Firmware upgrade/factory reset is running

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The LED brightness will automatically dim during a recording to ensure patient comfort.
Nox C1 Analog Inputs
Warning: The analog channels on the Nox C1 access point are signal
input/output (SIP/SOP) auxiliary ports not to be connected in direct galvanic
connection to the patient. This could result in electric shock.
The Nox C1 access point is equipped with 12 analog channels suitable for collecting of DC signals
from auxiliary devices. The channels are collected on 6 inputs, labeled DC IN from 1 to 12 on the
top of the device. The analog inputs which are 3.5 mm female stereo jack and yields 2 channels
each. The voltage range allows interfacing signals from -5 V to +5 V.
Auxiliary devices can be connected to the Nox C1 analog inputs using a standard 3.5 mm male
stereo jack or a 3.5 mm male mono jack.
The 12 analog channels offered by the Nox C1 have six inputs labeled DC IN from 1 to 12, see the
figure above. The table below addresses the channel identification.
Analog Inputs
Analog Channels 1-12
Analog Input 1 and 2
Channel 1
Channel 2
Analog Input 3 and 4
Channel 3
Channel 4
Analog Input 5 and 6
Channel 5
Channel 6
Analog Input 7 and 8
Channel 7
Channel 8
Analog Input 9 and 10
Channel 9
Channel 10
Analog Input 11 and 12
Channel 11
Channel 12

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The table below lists available commercial connectors that can be used for connection to the
Nox C1 analog channel inputs.
Connector Type
Channel Identification
3,5 mm male
stereo jack
A stereo jack can carry two
analog channels (e.g. channels
1 and 2)
3,5 mm male
mono jack
A mono connector can carry
one analog channel (e.g.
channel 1)
For the analog channel specifications refer to the “Specifications” section. Please refer to the
Noxturnal manual for more information on how to configure and license the analog channels.
Nox C1 Differential Pressure Sensor
To setup the Nox C1 access point for a recording of patient airflow at the proximal airway when
using a CPAP device, connect two Nox filter tube connectors to the differential pressure sensor
inputs on the rear of the device, labelled + PRES -. The differential pressure sensor inputs are
designed to fit directly with the filter tube connector interface from Nox Medical. The figure
below shows the Nox filter tube connectors connected to the differential pressure sensor inputs.
For the differential pressure sensor specifications refer to the “Specifications” section.
Nox C1 Serial Inputs
Warning: The serial channels on the Nox C1 access point are signal
input/output (SIP/SOP) auxiliary ports not to be connected in direct galvanic
connection to the patient. This could result in electric shock.
Odd number
channel
Even
number
channel
GND
Odd number
channel
GND

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To record signals from auxiliary devices over a serial connection connect a 3.5 mm male stereo
jack carrying the serial signal to a COM input on the rear of the Nox C1 access point. The figure
below shows the rear of the device, where the serial inputs are located. The serial inputs are
labelled 1COM 2. For the serial input specifications refer to the “Specifications” section.
Connector Type
Channel Identification
3,5 mm male
stereo jack
The COM stereo jacks carry
one serial channel each with
TxD, RxD and GND at RS232
levels.
Nox C1 Serial-over-USB Inputs
Warning: The USB channels on the Nox C1 access point are signal
input/output (SIP/SOP) auxiliary ports not to be connected in direct galvanic
connection to the patient. This could result in electric shock.
The Nox C1 access point contains USB ports that currently do not have any function within the
Nox Sleep System. The USB inputs are on the rear of the device. The figure below shows the rear
of the device, where the USB inputs are located. The USB inputs are labelled USB. For the USB
input specifications refer to the “Specifications” section.
TxD
RxD
GND

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Nox C1 Ambient Light Sensor
The Nox C1 access point has a built-in ambient light sensor located on the top panel of the
device; see the figure below (1).
The light sensor can be used for light detection in the patient room. For the light sensor to work
properly make sure not to cover the light sensor on the device. For the light sensor specifications
refer to the “Specifications” section.
NOX C1 NETWORK CONFIGURATION
Default Factory Configuration
The factory state of the Nox C1 access point is listed in the table below.
Nox C1 Network Configuration
Details
DHCP server
DHCP pool: 192.168.101.64 - 192.168.101.127
1

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Static IP address
192.168.101.10
Universal Plug and Play (UPnP)
discovery
Networking protocol that permits the Nox C1 to be
discovered on a network
The Nox C1 network configuration can be managed through the Noxturnal software. Please refer
to the Noxturnal manual for instructions on how to configure the Nox C1 network settings.
Factory Reset
To reset the Nox C1 access point to factory state follow the instructions below:
1. Unplug the power supply from the Nox C1 access point
2. Reset the device by performing the following:
i. Use a sharp pin (such as a toothpick) and press and hold the reset button on
the rear of the device (see figure below)
ii. While pressing the reset button connect the power supply to the device
iii. You can release the reset button once you see the device LED alternating
between green and amber
3. The LED on the top panel will blink amber while the device is completing the startup
sequence
4. After approximately 60 seconds the LED starts blinking green. This indicates that the
device has been reset to factory defaults and will have the network configuration listed
in the “Default Factory Configuration” section
NOTE: Do not use a metallic item to perform the factory reset.
NOX C1 ACCESS POINT SETUP
Nox Sleep System Network Overview
Before setting up the Nox C1 access point on the network read the following.
The Nox C1 access point should be connected to a 10/100 IP-enabled
Ethernet network to transfer configuration and study data between the
Nox C1 access point and the operator workstation running the Noxturnal
software. The Nox C1 replies to Internet control message protocol (ICMP)
echo requests and can be discovered with the Universal Plug and Play
(UPnP) protocol. The Nox C1 listens on TCP port 8080 for configuration
requests and on port 8888 for UPnP discovery requests.

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Any study data collected during a network outage is discarded and the
user will be notified in Noxturnal if such an event occurs.
NOTE: If the Nox C1 access point is connected to a shared network please
make sure that any device connected to the network does not cause
network congestion reducing the operational integrity of the Nox C1
access point.
To ensure steady operation of the Nox Sleep System please follow the recommended system
setup below.
Use a separate local area network (LAN) for each Nox C1 access point and a computer
running the Noxturnal software, i.e. each patient room that includes the Nox C1 should
be on a separate network.
Use a separate Nox C1 access point for each Nox A1 recorder to be used.
Use a separate computer running Noxturnal for each Nox C1 access point.
The table below describes the setup of the control room where the computer with Noxturnal
installed is located.
Control Room
Item
Connection
PC
Connected to the same network as the Nox C1
with a network cable
Noxturnal
Installed on PC
The table below describes the setup of the patient room where the patient is sleeping during a
sleep study.
Patient Room
Item Name
Description
Function
Setup/Connection
Nox C1
Access Point
Bluetooth access
point with analog
and serial inputs
and built in light
sensor and
differential
pressure sensor
Data transfer received
from Nox A1 over
Bluetooth connection
and forwarded to
Noxturnal via Ethernet
Commands received
from Noxturnal via
Ethernet and forwarded
to Nox A1 using
Bluetooth connection
Data transfer received
from auxiliary devices
connected to analog
and/or serial inputs and
forwarded to Noxturnal
via Ethernet
Located in the
patient room.
Connected to the
same LAN as the
PC running the
Noxturnal
software
Nox A1
Recording device
Records physiological
Attached to the

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Recorder
and
applicable
sensors
that may be
configured for
different types of
sleep studies
signals from built-in and
attached sensors
patient in the
patient room
Medical
auxiliary
devices
Any medical
device that fits
the input channel
specifications of
the Nox C1 Access
Point. Medical
devices
supported by the
system to be
connected to Nox
A1 Recorder via
Bluetooth link
Depends on the auxiliary
device being used
The applicable
connection cable
connected to the
analog
input/serial on
the Nox C1 Access
Point. Via
Bluetooth link to
the Nox A1
recorder
Noxturnal
App
Android App
Can be used to connect to
Online Rooms, review signal
traces and perform bio
calibration and impedance
check. Can also be used to
start and stop recordings
Set the App to
Online Mode and
connect to the
applicable online
room
The figure below shows the overview of the online setup for the Nox Sleep System .
The Nox C1 Access Point is operated by the Noxturnal software.
For instructions on how to configure and operate the Nox C1 Access Point and Nox A1 Recorder
from the Noxturnal software refer to the Noxturnal manual.
MAINTENANCE
The Nox Sleep System is only intended to be maintained by professionals (healthcare
professionals and service personnel) with relevant qualifications and skills.
The Nox C1 Access Point and accessories should be stored in a clean, dry place.
Handle the Nox C1 Access Point with care and protect it against mechanical shocks, dirt, and
liquids. The device is not waterproof or splash proof.

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To update the Nox C1 firmware you will need the Noxturnal software running on a computer
which is on the same network as the Nox C1 Access Point. Please refer to the Noxturnal manual
for more information on how to perform this task.
No regular testing of the Nox C1 access point is needed.
The service life of the Nox C1 Access Point and the FRIWO MP115 Medical-7555M/12 power
supply is 5 years.
Environmental Conditions
Note: The environmental conditions listed below apply both for
the Nox C1 Access Point and the accompanying FRIWO MP115
Medical-7555M/12 power supply.
Temperature
Operation: +5°C to +40°C (41°F to 104°F)
Transport/Storage: -25°C to +70°C (-13°F to 158°F)
Relative Humidity
Operation: 15-90% (non-condensing)
Transport/Storage: 10-95% (non-condensing)
Pressure
Withstands atmospheric pressures from 700 hPa to 1060 hPa
Calibration
The Nox C1 Access Point is factory calibrated. No further calibration is needed.
Warning: There are no user serviceable parts inside the Nox C1 Access Point.
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 C1 Access Point is
opened.
Warning: No modification of the Nox C1 Access Point is allowed. Un-
authorized modifications may affect data analysis and result in possible
incorrect treatment.
Cleaning
Warning: The Nox C1 Access Point 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: In the United States of America, only use United States
Environmental Protection Agency (EPA) registered products for cleaning of the
Nox C1 Access Point to prevent harm to the operator/patient