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Nukute Nukute Collare Manual Download Page 28

   

 

   

 

 

 

 

CONFIDENTIAL

 

 

 

VERSION 

2.0

  

 

 

 

 

   

 

   

 

  28  of  38 

 

4.3.

 

Disposal instructions 

When the Healthcare Professional wishes to discard the product or its parts, it must be sent 
to separate collection facilities for recovery and recycling. Please contact the nearest 
authorities to determine the proper method of disposal of potentially bio-hazardous parts 
and accessories.  

CAUTION! 

Pulse oximeter sensor is disposable, do not re-use it.   

 

4.4.

 

Service and repair 

CAUTION! 

If repair is needed, only Nukute authorized repair service must be used.    

CAUTION! 

Battery is not replaceable, if battery is not working contact Nukute support or 
distributor.  

WARNING! 

 Modification of this equipment is not allowed. 

 

If service operation is needed contact Nukute support or distributor:  

Nukute support email: 

[email protected]

 

 

 

Summary of Contents for Nukute Collare

Page 1: ...NUKUTE COLLARE MANUAL...

Page 2: ...2 of 38 NUKUTE COLLARE MANUAL Version 2 0 Latest Revision May 2020 Copyright 2020 Nukute All rights reserved MANUFACTURED BY Nukute Ltd M kelininkatu 43 90100 Oulu FINLAND www nukute com info nukute...

Page 3: ...LS 9 GETTING STARTED 12 2 1 UNPACKING 12 2 2 SYSTEM OVERVIEW 13 Carrying case 1 13 Tablet 2 13 Neckband and modules 3 4 5 6 7 8 14 Pulse oximeter 9 10 14 Cables and adapters 11 12 13 14 15 16 17 18 14...

Page 4: ...N 26 4 1 Technical specification 26 4 2 Environmental conditions 27 4 3 Disposal instructions 28 4 4 Service and repair 28 4 5 Warranty 29 4 6 Compliance to Standards and classifications 29 4 7 Essent...

Page 5: ...pacted by the measurement The system does not provide immediate results to the person after completing the measurement since the results need to be analyzed by a healthcare professional first Measurem...

Page 6: ...hcare professionals who will charge and disinfect the devices after every use 1 3 DISCLAIMER The manufacturer is responsible for safety reliability and performance of this production only in the condi...

Page 7: ...ngoing device needs to be powered off Do not use Collare or its parts if patient is under 18 years old There are no user serviceable parts The device should be serviced by authorized personnel only Se...

Page 8: ...etch Collare neckband more than needed to put it on your neck Make sure that environment is quiet and or other people noise snoring or child crying is not disturbing the measurement WARNING Keep the C...

Page 9: ...facturer Symbol also indicate the manufacturing date of the device Serial number Every part has unique serial number Fragile Handle with care Keep Away from water Temperature limitations Collare has o...

Page 10: ...fore using the device Type BF applied part Degree of protection applied part against electric shock classified as of type BF Parts in physical contact with the patient comply with IEC 60601 1 Collare...

Page 11: ...ter Second number 2 Protection against vertically falling water drops when enclosure tilted up to 15 WARNING There are some warnings when using Collare read them carefully before using the device CAUT...

Page 12: ...Measurement module 5 Neckband L 6 Neckband X 7 Neckband M 8 Neckband S 9 Pulse Oximeter 10 Pulse Oximeter Finger Sensor 11 Tablet Charging Cable 12 Tablet_Charger 13 Collare Charging Cable 14 USB Cha...

Page 13: ...ation Carrying case provides protection against water and dust IP22 Tablet 2 The tablet delivered with the Nukute sleep apnea measurement system is the primary source of user instructions Tablet is us...

Page 14: ...thing sound measurement and a motion sensor for sleeping position definition Pulse oximeter 9 10 Pulse oximeter with sensor is used for measuring patients oxygen saturation Note Pulse oximeter sensor...

Page 15: ...nly when quick quide with tablet is not giving answer for the problem Pulse oximeter finger tape 19 Pulse oximeter finger tape is used to secure the pulse oximeter sensor in index finger during measur...

Page 16: ...ching operating or maintaining the Collare System and its accessories to report unexpected operation or events Nukute customer service contact form in Nukute webpage www nukute com send email support...

Page 17: ...carrying case are four different size Collares X S M L The correct neckband is form fitting around the neck Both measurement sensors need to have close contact with skin at all time during measuremen...

Page 18: ...e and then assemble the measurement module to collare Make sure you can hear the click sound when attaching the Measurement module and battery module 4 TURN THE COLLARE ON Turn Collare on by pressing...

Page 19: ...ng directly to skin Before wearing the Collare make sure that skin is clean and free from lotion Tablet informs user to stand still for preparation tablet is connecting to Collare and ensuring the sou...

Page 20: ...nect it to oximeter Note Cover the sensor of strong light it may cause inaccurate measurement Note When measuring make sure that fingernails are not too long After attaching the sensor to pulse oximet...

Page 21: ...nforms the status on the Collare and pulse oximeter battery Before starting the measurement make sure that Collare and its parts are fully charged See charging instructions from chapter Charging Start...

Page 22: ...nt When waking up system can be shut down by pressing Collare power button for 2s Collare white blinking LED indicates that device is turning off Tablet informs user that recording has been ended By p...

Page 23: ...d cable or adapter If replacement cables or adapter is needed contact Nukute customer service or distributor Collare power plug 14 FRIWO type FW8002MUSB 05 Collare charging cable 13 GooBay type 45735...

Page 24: ...color depends on the status When device is charging LED is orange When battery is full LED is green If overtemperature or error occurs LED is red When charging is completed remove USB cable from the C...

Page 25: ...ase It is important to transport Collare and its parts in its accompanying carrying case 1 to ensure adequate protection and prevent damage 1 Sales Package 10 Pulse Oximeter Finger Sensor 2 Tablet 11...

Page 26: ...e Four different sizes X S M and L Weight 50 150 g Collare Battery Internal Li Ion Polymer 500 mAh Not replaceable Recording time 16h Charging time 1 5h Materials Comfortable plastic and elastomer Ser...

Page 27: ...hPa Transport and storage 700hPa to 1060hPa NOTE Please note that when environment temperature is 20 C the time required for Collare to warm from the minimum storage temperature between uses until it...

Page 28: ...disposal of potentially bio hazardous parts and accessories CAUTION Pulse oximeter sensor is disposable do not re use it 4 4 Service and repair CAUTION If repair is needed only Nukute authorized repa...

Page 29: ...te Collare is compliance with standard IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturban...

Page 30: ...ult in improper operation WARNING Portable and mobile RF radio frequency communications equipment for example mobile phone including peripherals such as antenna cables and external antennas can cause...

Page 31: ...proximity to other equipment CAUTION In case this Product is used around the other wireless devices including microwave and wireless LAN which operate same frequency band of this Product there is a po...

Page 32: ...ation electromagnetic emissions The Nukute Collare system is intended for use in the electromagnetic environment specified below The customer or the user of the Collare system should assure that it is...

Page 33: ...4 8 30A m 50 60Hz 30A m 50 60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Electrical fast transient burst...

Page 34: ...ng of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF EM fields IEC 61000 4 3 10V m Home healthcare at 80 MHz...

Page 35: ...e maintains basic safety and essential performance when used in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Nukute Collare can help pre...

Page 36: ...ser in case battery level is too low Please charge the device before continuing 2 Unexpected error If unexpected error occurs please turn the tablet off and restart the measurement flow 3 Neckband siz...

Page 37: ...follow the instructions from the tablet 5 Wireless signal problems When there are problems in wireless connection follow instructions from the tablet 6 Collare temperature is too low high If Collare t...

Page 38: ...und the patient s wrist Inaccurate readings and patient discomfort could result CAUTION Do not use a damaged sensor If the sensor is damaged in any way discontinue use immediately and replace the sens...

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