MANUAL
Copyright 2016 Nox Medical
Nox C1 Manual
Version 1.4
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 C1 device 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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Tab l e of Contents
Table of Contents ....................................................................................................... 3
Introduction ................................................................................................................ 5
Scope ..................................................................................................................... 5
Warnings and Cautions for Use ............................................................................. 5
Device Description ...................................................................................................... 8
Intended Use .......................................................................................................... 8
Contraindications ................................................................................................... 9
Nox C1 Interface .................................................................................................. 10
Device Inputs/Sensors .............................................................................................. 12
Connect to DC Power ........................................................................................... 13
Device Status ....................................................................................................... 15
Analog Inputs ....................................................................................................... 16
Differential Pressure Sensor ................................................................................ 17
Serial Inputs ......................................................................................................... 18
Serial-over-USB Inputs ......................................................................................... 18
Ambient Light Sensor ........................................................................................... 19
Network Configuration ............................................................................................. 20
Default Factory Configuration ............................................................................. 20
Factory Reset ....................................................................................................... 20
Setup Nox C1 Access Point with the Nox A1 System ................................................ 21
System Network Overview .................................................................................. 21
Maintenance............................................................................................................. 24
Compatible Sensors and Devices .............................................................................. 26
Specifications ............................................................................................................ 27
Nox C1 Device ...................................................................................................... 27
Regulatory Information ............................................................................................ 29
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Performance Testing and Validation Summary ................................................... 29
Classification ........................................................................................................ 29
Description of Symbols and Abbreviations .......................................................... 29
Bluetooth® Wireless Technology ......................................................................... 31
EMC Information.................................................................................................. 31
About ........................................................................................................................ 40
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Int r oduction
Congratulations on choosing the Nox C1 access point. The Nox C1 is a
Bluetooth® access point that enables measurement, receiving and streaming
of physiological signals during sleep. The Nox C1 is intended to be used with
the Nox A1 system to enable online functionality of the system.
Scope
This manual covers the instructions for the Nox C1 access point, and how to
setup and operate the device. This manual does not cover the software
application needed for the device configuration.
Warnings and Cautions for Use
Warning: The C1 device is NOT certified for continuous monitoring
where failure to operate can cause injuries or death of the patient.
Caution: U.S. federal law restricts the C1 device to sale by, or on the
order of, a licensed medical practitioner.
Caution: The C1 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 radiofrequency 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. Medical electrical
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: Electromagnetic interference (EMI) can be picked up by the
analog channels of the C1 device, causing disturbed or altered signals
to appear in the PC software. This may affect data analysis and result
in possible incorrect treatment.
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.
Warning: The C1 device should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the C1
device should be observed to verify normal operation in the
configuration in which it will be used.
Warning: The C1 device may be interfered with by other equipment,
even if that equipment complies with CISPR emission requirements.
Warning: The C1 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
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in electric shock.
Warning: Only use United States Environmental Protection Agency
(EPA) registered products for cleaning/disinfection of the C1 device.
Warning: Do not use damaged equipment, sensors or accessories.
This may result in bad performance of the device or patient/operator
injury.
Warning: There are no user serviceable parts inside the C1 device.
The C1 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 C1
device is opened.
Warning: No modification of the C1 device 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 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 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 recording software, in order
to prevent signals that would lead to incorrect interpretation and
possible incorrect treatment.
Warning: All the auxiliary devices connected to the C1 device 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: The C1 device may not be used for direct patient
connections where failure to operate can cause injuries or death of
the patient.
Warning: Only use power supply FRIWO MP115 Medical-7555M/12
with the C1 device. 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.
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Warning: The USB channels, serial channels and analog channels 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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Dev i c e Description
The Nox C1 access point is a Bluetooth® access point that enables
measurement, receiving and streaming of physiological signals during sleep.
The Nox C1 access point communicates with the Nox A1 recorder over
Bluetooth® and with the Noxturnal PC software over Ethernet to allow
configuration of the recorder and streaming of data. The Nox C1 is able to
measure signals from various auxiliary devices and has a built-in ambient light
sensor and a differential pressure sensor. The Nox C1 offers system extension
for the Nox A1 system with the integration of various auxiliary devices.
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; to support devices connected via USB
2 serial channels; for recording of serial signals from auxiliary devices
2 pressure sensor channels; for recording of differential pressure for
pneumoflow recordings
1 built-in ambient light sensor
1 built-in Bluetooth® module; to support wireless connectivity
allowing the device to record 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.
The Nox C1 access point is powered by a medical grade power supply
providing medical grade isolation from mains.
Intended Use
The Nox C1 access point is intended for measuring, receiving and streaming
of physiological signals during sleep. The Nox C1 access point communicates
with Nox recorders over Bluetooth® and with the Noxturnal PC software over
Ethernet to allow configuration of the recorders and streaming of data. The
Nox C1 access point receives Bluetooth® data stream from Nox recorders, has
input ports for measuring of signals originating from various auxiliary devices,
and has 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.
The Nox C1 access point is intended for patients older than two years of age.
The intended environments are professional healthcare facilities, including
hospitals, sleep centers and sleep clinics.
The Nox C1 Access Point is intended to be set-up by professionals (healthcare
professionals and service personnel) with relevant qualifications and skills.
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Contraindications
The Nox C1 access point is NOT intended for any continuous patient
monitoring or automatic diagnosis.
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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. See the figures and tables below
for detailed description.
Device Inputs and Sensors
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.
The figure on the next page shows the front view of the Nox C1, showing the
six analog inputs, labelled DC IN 1-12.
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
9 8 7 6 5
4
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Dev i c e I nputs/Sensors
The Nox C1 device 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.
Warning: Do not use damaged equipment, sensors or
accessories. This may result in bad performance of the device
or patient/operator injury.
Warning: The C1 device is NOT certified for continuous
monitoring where failure to operate can cause injuries or
death of the 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
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 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 recording software, in order to prevent
signals that would lead to incorrect interpretation and
possible incorrect treatment.
Warning: All the auxiliary devices connected to the C1 device
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: The C1 device may not be used for direct patient
connections where failure to operate can cause injuries or
death of the patient.
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Connect to DC Power
Warning: Only use power supply FRIWO MP115 Medical-
7555M/12with the C1 device. 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 device 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 to ensure safety and
device operation. For user instructions, product specifications and regulatory
information please refer to the product website: www.friwoshop.de/en/power-supplies/medical-power-supplies/169/mpp15medical?c=8970.
NOTE: Please read user instructions before use. Always
observe these instructions.
NOTE: The LED is the operating indicator.
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
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failures:
o Places, which are heavily exposed to moisture
or where water condensing may occur
o Places, which are exposed to special
environmental conditions
o Places, which are subject to constant vibrations
o Places, which are subject to high temperature
fluctuations
o Outdoors
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).
NOTE: A modification of the power supply is not allowed (Loss
of warranty).
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.
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Device Status
The Nox C1 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 turned on
A recording is not running
Solid green
A recording is running
Solid amber
Firmware error indication, device is not
functional
Alternating green
and amber
Device should be factory reset (refer to section
“Factory Reset”)
Firmware upgrade/factory reset is running
Do not unplug the power source
The LED brightness will automatically dim during a recording to ensure
patient comfort.
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Analog Inputs
Warning: The analog channels 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 device 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. Each analog input yields
2 channels. Auxiliary devices can be connected to the Nox C1 analog inputs
using standard 3.5 mm phono stereo connectors/3.5 mm mono phono
connectors/3.5 mm stereo to dual mono adapters. The voltage range allows
interfacing signals from -5 V to +5 V.
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 connectors that can be used for connection to the Nox
C1 analog channel inputs.
Connector Type
Channel Identification
3,5 mm stereo
phono connector
A stereo connector is able to
carry two analog channels
(e.g. channels 1 and 2)
3,5 mm mono
phono connector
A mono connector is able to
carry one analog channel (e.g.
channel 1)
3,5 mm stereo to
dual mono
adapter
White connector is for odd
number channels (e.g.
channels 1, 3, 5 etc.)
Red connector is for even
number channels (e.g.
channels 2, 4, 6 etc.)
Please refer to the Noxturnal software user manual for more information on
how to configure the analog channels.
Differential Pressure Sensor
To setup the Nox C1 for a pneumoflow recording, 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.
Channel 1
Channel 2
Ground
Channel 1
Ground
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Serial Inputs
Warning: The serial channels 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.
To record signals from auxiliary devices over a serial connection connect a
3.5 mm stereo phono connector carrying the serial signal to the serial input
on the rear of the device. The figure below shows the rear of the device,
where the serial inputs are located. The serial inputs are labelled 1 COM 2.
Serial-over-USB Inputs
Warning: The USB channels 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 device supports serial-over-USB dongles, allowing the user to connect
more than two serial auxiliary devices simultaneously. 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.
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Ambient Light Sensor
The Nox C1 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 Nox C1 light sensor.
For the light sensor specifications refer to the “Specifications” section.
1
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Net w ork Configuration
Default Factory Configuration
The factory state of the Nox C1 is listed in the table below.
Nox C1 Network
Configuration
Details
DHCP server
DHCP pool: 192.168.101.64 - 192.168.135.128
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 to factory state follow the instructions below:
1. Unplug the power supply from the Nox C1 device
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.
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Se tu p Nox C1 Access Point with t he N ox A1 System
System Network Overview
Before setting up the C1 access point on the network read through the
following.
The C1 access point should be connected to a 10/100 IP-enabled
Ethernet network in order to transfer configuration and study data
between the C1 access point and the operator workstation. The C1
access point replies to Internet control message protocol (ICMP) echo
requests and can be discovered with the UPnP protocol. The C1
access point listens on TCP port 8080 for configuration requests and
on port 8888 for UPnP discovery requests.
Any study data collected during a network outage is discarded and
the user will be notified if such an event occurs.
NOTE: If the 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 C1
access point.
To ensure steady operation of the Nox C1 with the Nox A1 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.
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The tables below describe the patient and control room device setup.
Patient Room
Item Name
Description
Function
Setup/Connection
Nox C1
device
Bluetooth®
access point with
analog and serial
inputs and builtin light sensor
and differential
pressure sensor
Communicates with
the Nox A1 using
Bluetooth®. Via
Ethernet:
Data transfer
from Nox A1 to
Noxturnal
Commands from
Noxturnal to Nox
A1
Data transfer
from connected
serial or analog
channel
connected
auxiliary devices
Located in the
patient room.
Connected to the
same LAN as the
PC running the
Noxturnal software
Nox A1
recorder
and the
applicable
sensors
PSG sleep
recorder
Records physiological
signals from
attached/connected
sensors
Attached to the
patient in the
patient room
Medical
auxiliary
devices
Any medical
device that fits
the input
channel
specifications of
the Nox C1
device (For
channel
specifications
refer to the
“Specifications”
section)
Depends on the
auxiliary device being
used
The applicable
connection cable
connected to the
analog/serial/USB
input on the Nox
C1 device
Control Room
Item
Connection
PC
Connected to the same network as
the Nox C1 with a network cable
Noxturnal
Installed on PC
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System Local Area Network Overview
The figure below shows an overview of the Nox C1 and Nox A1 network
system setup.
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.
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Mai ntenance
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.
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. Please refer to
the Noxturnal software user manual for more information on how to perform
this task.
No regular testing of the C1 access point is needed.
The service life of the Nox C1 is 5 years. The service life of the FRIWO MP115
Medical-7555M/12 power supply is 5 years.
Environmental Conditions
Temperature
Operation: +5°C to +50°C (41°F to 122°F)
Transport/Storage: -25°C to +70°C (-13°F to 158°F)
Relative Humidity
Operation: 15-95% (non-condensing)
Transport/Storage: 10-95% (non-condensing)
Pressure
Withstands atmospheric pressures from 700 hPa to
1060 hPa
Calibration
The Nox C1 device is factory calibrated. No further calibration is needed.
Warning: There are no user serviceable parts inside the C1
device. The C1 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 C1 device is opened.
Warning: No modification of the C1 device is allowed. Un-
authorized modifications may affect data analysis and result
in possible incorrect treatment.
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~ 25 ~
Cleaning
Clean the Nox C1 access point with a soft cloth dampened with hospital grade
cleaner that is not corrosive to plastic or metal. Do not pour or spray any
liquids onto the device, and do not allow any liquids to enter any openings on
the device. Allow the unit to dry thoroughly before use.
For disinfection of the Nox C1 device the following materials may be used:
Sodium hypochlorite diluted with water at 1:500 (bleach)
70-90% isopropanol
Super Sani-Cloth Plus disinfection wipes (from PDI)
Warning: The C1 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 C1 device.
The Nox C1 access point is NOT intended to be sterilized.
Regarding cleaning/disinfection and re-use of 3
rd
party
components and 3rd party sensors refer to the applicable 3rd
party accompanying instructions.
Disposal
Follow local governing ordinances and recycling instructions regarding
disposal or recycling of this device.
According to the regulation in Europe on Waste of Electrical and
Electronic Equipment (WEEE) the components labeled with this
symbol may not be disposed of as unsorted municipal waste.
The components shall be collected separately and returned to
the appropriate collection system available.
Please contact your distributor regarding take-back or recycling
of the components.
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Com patible Sensors a n d Devices
The following table includes information on accessories, sensors and devices
that have been validated with the Nox C1 access point.
The items listed below are Nox products and have been validated for use with
the Nox C1 device:
FILTER TUBE CONNECTORS
Type
Catalog Number
Nox Filter Tube Connector, 50 units
552110
A1 SYSTEM
Type
Catalog Number
Nox A1 System
513010
Nox A1 Recorder
561410
Noxturnal CD
539010
The items listed below are 3rd party products and have been validated for
use with the Nox C1 device:
POWER SOURCE
Type
Catalog Number
FRIWO MP115 Medical-7555M/12
-
ACCESSORIES FOR DIFFERENTIAL PRESSURE SENSOR
Type
Catalog Number
Mask tubing 183 cm (72 in) Female x Male
552320
Pneumoflow Sensor
552810
CLEANING
Type
Catalog Number
Super Sani-Cloth Plus Disinfection Wipes
559010
Nox C1 Manual
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Sp ecifications
Nox C1 Device
DESCRIPTION
PROPERTIES
FUNCTION
Channels
Ambient Light Channel
Differential Pressure Channel
Twelve Analog Input Channels
Two USB Input Channels
Two Serial Input Channels
PHYSICAL
Nox C1 Device
Dimensions
135 mm x 149 mm x 26 mm (5.3" x 5.9" x 1.0")
Nox C1 Weight
264 g (9.3 oz)
DC Inputs
Number of Channels: 12
Number of Inputs: 6
Input Voltage Range: +/- 5 V
Sampling: 16 bit, 250 sample/s
Connector: 3.5 mm Female Stereo Jack
Light Sensor Input
Light Range: Can distinguish between dark room and
a slightly lit room
Sampling: 16 bit, 250 sample/s
Light Indicator
Number of LEDs: 1
Colors: Green and Amber for status indication
Pressure Sensor Input
Number of Inputs: 2
Absolute Maximum Input Pressure: +/- 7 kPa
Pressure Input Range: +/- 20 cmH
2
O
Sampling: 16 bit, 250 sample/s
USB Inputs
Number of Inputs: 2
USB 2.0 compliance
High Speed (up to 480 Mbit/s)
Connector: USB Type A
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~ 28 ~
Serial Inputs
Number of Inputs: 2
RS-232
Connector: 3.5 mm Female Stereo Jack
POWER SOURCE
Power Supply Model
FRIWO MP115 Medical-7555M/12
Nominal Input Voltage
100-240 V AC
Nominal Input
Frequency
50-60 Hz
Nominal Input Current
0.350-0.150 Arms (at max load)
Nominal Output Voltage
12 V DC
Nominal Output Current
1250 mA
COMMUNICATION
Bluetooth®
Bluetooth® v.4.0
Bluetooth Classic and Bluetooth Low Energy dual
mode compliant
Operating frequency: 2.402-2.480 GHz
Bandwidth: 2 MHz
Transmit power: 10 mW max.
Range: up to 35 meters in line-of-sight
Antenna type: Internal
Network Topology: Point-to-Point: Point-to-
Multipoint
Operation: Scatter-Net Master
Modulation Type: Frequency Shift Keying/Frequency
Hopping Spread Spectrum
Ethernet
Number of Inputs: 1
10/100 BASE-TX
Connector: RJ-45
LED Indicators: Green-Link activity, Amber-100
Mbit/s indication
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Reg u l atory Informati o n
Performance Testing and Validation Summary
The Nox C1 access point has been tested and verified in various phases to
include internal testing, verification and validation as well as external testing
to assure product safety, effectiveness and reliability. The design was verified
and validated, including clinical evaluation, throughout the design process,
according to requirement specifications and intended use. External
accredited test houses were used to conduct testing needed to comply with
the applicable standards regarding EMC and patient safety as well as
additional RF testing to assure compliance to R&TTE.
Nox Medical holds a CMDCAS ISO 13485:2003 certified Quality Management
System which complies with the requirements of the Medical Device
Directive (MDD), FDA Quality System Regulation (QSR) and Canada Medical
Device Regulations (CMDR).
Classification
Degree of protection against electric shock: The device is
classified as class II equipment (see the symbol to the left).
Powering of the device: The device is powered from an
external electrical power source.
Degree of protection against harmful ingress of liquids and
particulate matter: The device is classified IP20, i.e., as
defined by the standard IEC 60529 it is protected against
solid foreign objects of 12,5 mm diameter and greater, but
it is not protected against harmful ingress of liquids.
Method of sterilization: The device is NOT delivered sterile
or intended to be sterilized.
Suitability for use in an oxygen rich environment: The
device is NOT intended for use in an oxygen rich
environment.
Suitability for use with flammable agents and anesthetics:
The device is NOT intended for use in conjunction with
flammable agents or with flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
Mode of operation: The device is intended for continuous
operation.
Description of Symbols and Abbreviations
Operating instructions / Consult instructions
for use
Nox C1 Manual
~ 30 ~
Caution
(01)15694311110590(11)
YYMMDD(21)931XXXXXX
Unique Device Identifier (UDI); (01)
represents the device identifier (DI)
(“15694311110590”), (11) the
production date/date of manufacture
(“YYMMDD”, with “YY” the last two
digits of the production year, “MM” the
production month and “DD” the
production day), and (21) the serial
number (“931XXXXXX”)
Class II equipment
In compliance with the European
Directive on Waste of Electrical and
Electronic Equipment (WEEE)
2002/96/EC, do not dispose of this
product as unsorted municipal waste
Non-ionizing radiation. The equipment
includes a RF transmitter: interference
may occur in the vicinity of equipment
marked with this symbol
CE marking indicating conformance to EC
directives 93/42/EEC and 2007/47/EC
concerning medical devices
Nox C1
Brand name/Model name
SCOM1
Technical name
REV
Revision of the device
Contains IC ID: 5123ABGTBT111
Industry Canada (IC) ID label
Contains FCC ID: QOQBT111
Federal Communications Commission
(FCC) ID label
DC IN 1-12
Analog inputs
LAN
Ethernet cable input
USB
USB inputs
1
COM 2
Serial inputs
Nox C1 Manual
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+
PRES -
Differential pressure sensor inputs
DC power supply connector
Bluetooth® 4.0 wireless technology
Federal Communications Commission
(FCC) logo
Keep dry
Fragile, handle with care
Bluetooth® Wireless Technology
The C1 access point uses Bluetooth® 4.0 wireless technology to receive
signals from external Bluetooth modules.
The Bluetooth wireless technology is based on a radio link that offers fast and
reliable transmission of data. Bluetooth radio uses globally available
frequency range in the industrial, scientific and medical (ISM) band, intended
to ensure communication compatibility worldwide and a fast
acknowledgement and frequency-hopping scheme to make the link robust,
even in noisy radio environments. Please refer to the “Specifications” section
for details on RF specifications for the C1 access point.
The Bluetooth® word mark and logos are registered trademarks owned by the
Bluetooth SIG, Inc. and any use of such marks by Nox Medical is under
license. Other trademarks and trade names are those of their respective
owners.
EMC Information
Portable and mobile RF communications can affect the
performance of the device.
Warning: Electromagnetic interference (EMI) can be
picked up by the analog channels of the C1 device, causing
disturbed or altered signals to appear in the PC software.
This may affect data analysis and result in possible
incorrect treatment.
Warning: The C1 device should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use
is necessary, the C1 device should be observed to verify
normal operation in the configuration in which it will be
used.
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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.
Warning: The C1 device may be interfered with by other
equipment, even if that equipment complies with CISPR
emission requirements.
Refer to the tables below in this section for specific
information regarding the C1 device’s compliance to the
standard IEC60601-1-2.
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Declarations of Conformity with the US Federal
Communications Commission (FCC) and Industry Canada
Regulations
USA - FEDERAL COMMUNICATIONS COMMISSION (FCC)
The C1 device complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference, including interference that
may cause undesired operation of this device.
FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment. End users must follow the specific operating
instructions for satisfying RF exposure compliance. This transmitter meets
both portable and mobile limits as demonstrated in the RF Exposure Analysis
and should not be used closer than 5 mm from a human body in portable
configuration. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter except in accordance with
FCC multi-transmitter product procedures.
CANADA - INDUSTRY CANADA (IC)
This device complies with Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) this device may not
cause interference, and (2) this device must accept any interference,
including interference that may cause undesired operation of the device.
Under Industry Canada regulations, this radio transmitter may only operate
using an antenna of a type and maximum (or lesser) gain approved for the
transmitter by Industry Canada. To reduce potential radio interference to
other users, the antenna type and its gain should be so chosen that the
equivalent isotropically radiated power (e.i.r.p.) is not more than that
necessary for successful communication.
COMPLIANCE WITH FCC AND INDUSTRY CANADA REGULATIONS
The antenna(s) must be installed such that a minimum separation
distance of 5 mm is maintained between the radiator (antenna) and
all persons at all times.
The transmitter module must not be co-located or operating in
conjunction with any other antenna or transmitter except in
accordance with FCC multi-transmitter product procedures.
MODIFICATION STATEMENT
Any changes or modifications not expressly approved by Nox Medical could
void the user’s authority to operate the equipment.
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Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The C1 device is intended for use in the electromagnetic environment specified below.
The customer or the user of the C1 device should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 2
The C1 device must emit electromagnetic energy
in order to perform its intended function. Nearby
electronic equipment may be affected.
RF emissions
CISPR 11
Class B
The C1 device is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The C1 device is intended for use in the electromagnetic environment specified below.
The customer or the user of the C1 device should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burs
t
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV lines(s)
to earth
± 1 kV line(s)
to line(s)
± 2 kV
lines(s) to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and
voltage
variations
on power
supply
input lines
IEC 61000-411
<5 % UT
(>95 % dip in
UT) for 0,5
cycle
40 % UT
(60 % dip in
UT) for 5 cycles
70 % UT
(30 % dip in
UT) for 25
cycles
<5 % UT
(>95 % dip in
UT) for 5 s
<5 % UT
(>95 % dip in
UT) for 0,5
cycle
40 % UT
(60 % dip in
UT) for 5
cycles
70 % UT
(30 % dip in
UT) for 25
cycles
<5 % UT
(>95% dip in
UT) for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the C1 device requires
continued operation during
power mains interruptions, it is
recommended that the C1 device
be powered from an
uninterruptible power supply or a
battery.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Nox C1 Manual
~ 36 ~
NOTE UT is the a.c. mains voltage prior to application of the test level.
Nox C1 Manual
~ 37 ~
Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity (Continued)
Guidance and manufacturer’s declaration – electromagnetic immunity
The C1 device is intended for use in the electromagnetic environment specified below.
The customer or the user of the C1 Device should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment –
guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of C1 device, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 V
rms
150 kHz to 80
MHz
3 V
d = 1.2 √P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
Nox C1 Manual
~ 38 ~
a
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the C1 device is used exceeds the applicable RF compliance level
above, the C1 device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting
or relocating the C1 device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
Nox C1 Manual
~ 39 ~
Recommended Separation Distance between Portable and
Mobile RF Communications Equipment and the C1 Device
Recommended separation distance between portable and mobile RF
communications equipment and the C1 device
The C1 device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the C1 device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
C1 device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of
transmitter
m
150 kHz to 80
MHz
d = 1.2 √P
80 MHz to 800
MHz
d = 1.2 √P
800 MHz to 2.5
GHz
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
Nox C1 Manual
~ 40 ~
About
This manual is provided in electronic format according to Commission
Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for
use of medical devices.
This manual is provided as a pdf document. PDF readers are commonly
available at no cost for users.
This manual is also available on Nox Medical’s website:
support.noxmedical.com/hc/en-us/articles/207379426.
A hard copy can be requested at no additional cost by emailing
support@noxmedical.com. The hard copy will be sent within 7 calendar days.
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