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US MANUAL

Copyright 2020 Nox Medical

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Summary of Contents for Nox C1

Page 1: ...US MANUAL Copyright 2020 Nox Medical ...

Page 2: ...ication 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 License Notice The Nox C1 Access Point uses software components covered by open source licenses Licenses covering t...

Page 3: ... Point Status 12 Nox C1 Access Point Analog Inputs 13 Nox C1 Access Point Differential Pressure Sensor 14 Nox C1 Access Point Serial Inputs 15 Nox C1 Access Point Serial over USB Inputs 15 Nox C1 Access Point Ambient Light Sensor 16 Nox C1 ACCESS POINT Network Configuration 17 Default Factory Configuration 17 Factory Reset 17 Nox C1 Access Point Setup 18 Nox Sleep System Network Overview 18 Mainte...

Page 4: ... 4 Regulatory Information 28 Performance Testing and Validation Summary 28 Nox C1 Classification 28 Description of Symbols and Labels 28 Bluetooth Wireless Technology 31 Electromagnetic Compatibility EMC Information 31 ...

Page 5: ...uman subjects or sleep disorder investigation The intended environments are hospitals institutions sleep centers sleep clinics or other test environments including patient s home Note The Nox C1 Access Point is only needed during online setup of the Nox Sleep System and never used during ambulatory setup of the Nox Sleep System The Nox C1 Access Point is thus not intended to be used in the home en...

Page 6: ...is 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...

Page 7: ...iary signal to the Nox C1 Access Point 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 US software in order to prevent signals th...

Page 8: ...e signals from the Nox A1 Recorder The Nox C1 Access Point 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 Access Point communicates with the Nox A1 Recorder and Noxturnal App over Bluetooth link and with the Noxturnal US PC software over Ethernet to...

Page 9: ...Nox C1 US Manual 9 The figure below shows the front view of the Nox C1 Access Point showing the six analog inputs labelled DC IN 1 12 3 2 1 ...

Page 10: ...rresponding 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 ha...

Page 11: ...tor 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 Access Point is available for configuration FRIWO MP115 Medical ...

Page 12: ...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 Access Point Status The Nox C1 Access Point has a built in LED for devic...

Page 13: ...vice 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 Access Point analog inputs using a standard 3 5 mm male stereo jack or a 3 5 mm male mono jack such as the Sinbon C1 Splitter Cable 562014 The Sinbon C1 Extension cable 562012 can be used for extension pu...

Page 14: ...Devices that have been validated with the Nox C1 Access Point Nox C1 Access Point Differential Pressure Sensor To setup the Nox C1 Access Point for a recording of patient airflow at the proximal airway when using a PAP 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...

Page 15: ...tor 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 Refer to the Compatible Devices Sensors and Accessories section regarding the types of Auxiliary Devices and accessories that have been validated with the Nox C1 Access Point Nox C1 Access Point Serial over USB Inputs Warning The USB channels on the Nox C1...

Page 16: ...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 1 ...

Page 17: ...eset 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 b...

Page 18: ...1 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 Noxt...

Page 19: ... for different types of sleep studies Records physiological signals from built in and attached sensors and pulse oximeter data over Bluetooth link Device and sensors are applied to the patient Medical Auxiliary Devices Supported medical devices medical devices that fits the analog input channel specifications of the Nox C1 Access Point Depends on the auxiliary device being used The applicable conn...

Page 20: ... studies in total given that 200 studies are performed in a year 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 1...

Page 21: ...Germicidal Disposable Cloth or equivalent validated disinfectant CLEANING DISINFECTING PROCEDURE 1 Prepare a solution with the Endozime AW Plus hospital grade cleaner o Follow the instructions accompanying the hospital grade cleaner 2 Dampen a lint free cloth with the solution o Do not pour or spray any liquids on the Nox C1 Access Point o Do not allow any liquids to enter any openings on the Nox ...

Page 22: ...cal devices in the United States of America If any component damage occurs during cleaning process contact Nox Medical immediately at support noxmedical com Do not attempt to use the Nox C1 Access Point until the device has been inspected and repaired by authorized Nox Medical personnel For cleaning of FRIWO MP115 Medical 7555M 12 power supply only use dry cloth Do not clean with detergents Warnin...

Page 23: ...ualified medical technician or your local representative Caution After connecting a new auxiliary signal to the Nox C1 Access Point 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 t...

Page 24: ...AS AND MICROPHONES Type Catalog Number Trendnet PoE Switch NA CONNECTION CABLES Type Catalog Number Sinbon C1 Serial Cable 562013 Sinbon C1 Splitter Cable 562014 Sinbon C1 Extension cable 562012 AUXILIARY DEVICES SUPPORTED Type Catalog Number SenTec SDM NA Radiometer TCM4 CombiM NA Radiometer TCM40 TCM TOSCA NA The 3rd party FRIWO MP115 Medical 7555M 12 medical grade power supply has been validate...

Page 25: ...M10 NA Resmed S9TM NA Resmed Aircurve NA Masimo Radical 7 Tabletop Oximeter NA Nonin Model 7500 Tabletop Oximeter NA DIFFERENTIAL PRESSURE SENSOR Type Catalog Number Pneumoflow Sensor 552810 CLEANING Type Catalog Number PDI Sani Cloth Plus Germicidal Disposable Cloth NA ...

Page 26: ...nnels 12 Number of Inputs 6 Input Voltage Range 5 V Sampling 16 bit 250 sample s Connector 3 5 mm Female Stereo Jack Nox C1 Light Sensor Input Light Range Can distinguish between dark room and a slightly lit room Sampling 16 bit 250 sample s Nox C1 Light Indicator Number of LEDs 1 Colors Green and Amber for status indication Nox C1 Pressure Sensor Input Number of Channels 1 Number of Inputs 2 Abso...

Page 27: ...Number of Inputs 2 RS 232 Connector 3 5 mm Female Stereo Jack POWER SUPPLY Power Supply Model FRIWO MP115 Medical 7555M 12 Nominal Input Voltage 100 240 V AC 10 Nominal Input 50 60 Hz Nominal Input Current 0 350 0 150 Arms at max load Nominal Output Voltage 12 V DC 5 Nominal Output Current 0 1250 mA COMMUNICATION Nox C1 Bluetooth Bluetooth v 4 0 Nox C1 Ethernet Number of Inputs 1 10 100 BASE TX Co...

Page 28: ... Full Quality Assurance Procedure Japan MHLW Ministerial Ordinance 169 Article 4 to Article 68 PMD Act and USA 21 CFR 820 21 CFR 803 21 CFR 806 21 CFR 807 Subparts A to D Nox C1 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 Deg...

Page 29: ...YY the last two digits of the production year MM the production month and DD the production day and the Application Identifier 21 the serial number of the device 931XXXXXX Unique Device Identifier UDI presented in data matrix format Class II equipment Non ionizing radiation The equipment includes a RF transmitter interference may occur in the vicinity of equipment marked with this symbol Bluetooth...

Page 30: ...R Magnetic Resonance Environment Contains FCC ID QOQBT111 Federal Communications Commission FCC ID label DC IN 1 12 Analog inputs DC LAN Ethernet cable input USB USB inputs currently nonfunctional 1 COM 2 Serial inputs PRES Differential pressure sensor inputs DC power supply connector ...

Page 31: ...ufacturer Otherwise degradation of the performance of this equipment could result Warning Electromagnetic interference EMI can be picked up by the analog and or serial channels of the Nox C1 Access point causing disturbed or altered signals to appear in the Noxturnal US software This may affect data analysis and result in possible incorrect treatment Warning The Nox C1 Access Point s should not be...

Page 32: ...oth 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 COMPLIANCE WITH FCC REGULATIONS The antenna s must be installed such...

Page 33: ... that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The 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 device is suitable for use in all establishments including domestic establishments and those directly c...

Page 34: ...to line 0 5 kV 1 kV 2 kV lines to ground 0 5 kV 1 kV and 2 kV Voltage dips IEC 61000 4 11 0 UT for 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle 70 UT for 25 30 cycles A C power port 0 UT for 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle 70 UT for 25 30 cycles Voltage Interruptions IEC 61000 4 11 0 UT for 250 300 cycles A C power port 0 UT for 250 300 cycles Rated p...

Page 35: ...equipment IEC 61000 4 3 Refer to IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT section Refer to IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT section NOTE UT is the a c mains voltage prior to application of the test level ...

Page 36: ...0 390 TETRA 400 Pulse modulation 18Hz 1 8 0 3 27 Yes 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 Yes 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 Yes 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 Yes 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz ...

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