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Nox Medical Nox C1 Manual

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MANUAL
Copyright 2016 Nox Medical

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Summary of Contents for Nox Medical Nox C1

  • Page 1 MANUAL Copyright 2016 Nox Medical...
  • Page 2 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.

  • Page 3: Table Of Contents

    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 ......................
  • Page 4 Nox C1 Manual Performance Testing and Validation Summary ........... 29 Classification ......................29 Description of Symbols and Abbreviations ............29 Bluetooth® Wireless Technology ................. 31 EMC Information....................31 About ........................40 ~ 4 ~...

  • Page 5: Introduction

    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.
  • Page 6 Nox C1 Manual 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.
  • Page 7 Nox C1 Manual  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.

  • Page 8: Device Description

    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.

  • Page 9: Contraindications

    Nox C1 Manual Contraindications The Nox C1 access point is NOT intended for any continuous patient monitoring or automatic diagnosis. ~ 9 ~...

  • Page 10: Nox C1 Interface

    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.
  • Page 11 Nox C1 Manual 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.

  • Page 12: Device Inputs/Sensors

    Nox C1 Manual Device Inputs/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.

  • Page 13: Connect To Dc Power

    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.
  • Page 14 Nox C1 Manual failures: Places, which are heavily exposed to moisture or where water condensing may occur Places, which are exposed to special environmental conditions Places, which are subject to constant vibrations Places, which are subject to high temperature fluctuations Outdoors ...

  • Page 15: Device Status

    Nox C1 Manual 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.

  • Page 16: Analog Inputs

    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.

  • Page 17: Differential Pressure Sensor

    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.

  • Page 18: Serial Inputs

    Nox C1 Manual 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...

  • Page 19: Ambient Light Sensor

    Nox C1 Manual 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.

  • Page 20: Network Configuration

    Nox C1 Manual Network Configuration Default Factory Configuration The factory state of the Nox C1 is listed in the table below. Nox C1 Network Details Configuration DHCP server DHCP pool: 192.168.101.64 - 192.168.135.128 Static IP address 192.168.101.10 Universal Plug and Play (UPnP)

  • Page 21: Setup Nox C1 Access Point With The Nox A1 System

    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.
  • Page 22 Nox C1 C1 device auxiliary device (For devices channel specifications refer to the “Specifications” section) Control Room Item Connection Connected to the same network as the Nox C1 with a network cable Noxturnal Installed on PC ~ 22 ~...
  • Page 23 Nox C1 Manual 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.

  • Page 24: Maintenance

    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)
  • Page 25 Nox C1 Manual 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.

  • Page 26: Compatible Sensors And Devices

    Compatible Sensors and 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:...

  • Page 27: Specifications

    Nox C1 Manual Specifications 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 135 mm x 149 mm x 26 mm (5.3" x 5.9" x 1.0") Dimensions ...
  • Page 28 Nox C1 Manual  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 50-60 Hz Frequency ...

  • Page 29: Regulatory Information

    Regulatory Information 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.
  • Page 30 Nox C1 Manual  Caution  Unique Device Identifier (UDI); (01) (01)15694311110590(11) represents the device identifier (DI) YYMMDD(21)931XXXXXX (“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”)

  • Page 31: Bluetooth® Wireless Technology

    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.
  • Page 32 Nox C1 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.  Warning: The C1 device may be interfered with by other equipment, even if that equipment complies with CISPR emission requirements.
  • Page 33 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. ~ 33 ~...
  • Page 34 Nox C1 Manual 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.
  • Page 35 Nox C1 Manual 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.
  • Page 36 Nox C1 Manual NOTE is the a.c. mains voltage prior to application of the test level. ~ 36 ~...
  • Page 37 Nox C1 Manual 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.
  • Page 38 Nox C1 Manual 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.
  • Page 39 Nox C1 Manual 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.

  • Page 40: About

    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.

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