Nukute Nukute Collare User manual

NUKUTE COLLARE MANUAL

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NUKUTE COLLARE MANUAL
Version 2.0
Latest Revision: May 2020
Copyright © 2020
Nukute –All rights reserved
MANUFACTURED BY
Nukute Ltd
Mäkelininkatu 43
90100 Oulu
FINLAND
www.nukute.com
[email protected]
Tel. [phone]

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INTRODUCTION ..............................................................................................................................................5
1.1. CONTACT INFORMATION..................................................................................................................6
1.2. INTENDED USE .......................................................................................................................................6
1.3. DISCLAIMER.............................................................................................................................................6
1.4. CONTARAINDICATIONS AND PRECAUTIONS............................................................................7
1.5. SYMBOLS ..................................................................................................................................................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
Quick start guide (18)............................................................................................................... 15
Pulse oximeter finger tape (19)............................................................................................ 15
2.3. Accessory Kit......................................................................................................................................... 15
FREQUENTLY USED FUNCTIONS ........................................................................................................... 16
3.1. Instructions............................................................................................................................................ 16
3.2. Starting the measurement............................................................................................................... 16

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3.3. Ending of the measurement........................................................................................................... 22
3.4. Charging................................................................................................................................................. 23
Charging the Collare ................................................................................................................ 24
Charging the pulse oximeter................................................................................................. 24
Charging the tablet................................................................................................................... 24
3.5. Packing instructions........................................................................................................................... 25
INFORMATION.............................................................................................................................................. 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. Essential performance....................................................................................................................... 29
4.8. Electromagnetic compatibility (EMC) information................................................................. 29
4.9. Troubleshooting.................................................................................................................................. 36
4.10. Measuring Pulse Oxygen using Berry Electronics Pulse oximeter............................... 38
4.11. Declaration of conformity........................................................................................................... 38

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INTRODUCTION
This is Manual for Nukute Collare system. Latest version of the manual can read in electric
form in address: www.nukute.com/support/manual
Instruction for use explains the safety issues and introduces the device and its usage. The
device must be used according to this user manual.
Nukute Collare system is used for recording the biosignals of a person during his or her
sleep in order to determine whether the person might have sleep apnea. The system is
designed to be easy to use and comfortable to wear so that the sleep quality of the person is
not impacted 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. Measurement data is sent automatically to a cloud service from
where the doctor can access the results and make diagnostics decisions accordingly. Patient
should always consult their doctor for the results after the measurement.
The Nukute Collare device is classified according to the Annex IX of the Medical Device
Directive 93/42/ EEC. According to the definition 1.6 the device is an active device for
diagnosis. Although not directly used for diagnosis, the device provides information by
monitoring physiological conditions. Thus, according to implementing rule 10, Collare is
classified as Class IIa device.

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1.1. CONTACT INFORMATION
In case you want to contact Nukute:
Nukute Oy
Mäkelininkatu 43
90100 Oulu
FINLAND
www.nukute.com,
[e-mail]
Tel. [phone]
1.2. INTENDED USE
Nukute Collare device is intended for the screening of sleep apnea in adult patients.
The device can be used either in home environment or in the hospitals. A medical doctor´s
referral is always required for the screening with Nukute Collare. The device is intended to be
maintained at hospitals by healthcare 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 condition that:
-All installation operations, expansions, changes, modifications, and repairs of this
product are conducted by manufacturer authorized personnel.
-The product is operated under observance of this manual.
-Nukute 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 product.
-All clinical conclusions and decisions that are based on the use of this product are the
responsibility of the sleep specialist.

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1.4. CONTARAINDICATIONS AND PRECAUTIONS
-Patient must be 18 years or older.
-Patient has no neck injuries, skin in the neck area is intact.
-Patient should not have pacemaker or stimulators.
-Patient is able to follow the instructions and use the device in home environment. In
hospital environment use patient state is not relevant
CAUTION!
-It is important to read safety issues before using the Nukute Collare system.
-It is not allowed to use other power adapter than that is inside the carrying package.
Power adapter needs to be medical approved and tested against IEC 60601-1.
-Maintenance while device is in use is not allowed. Every time when maintenance is
ongoing 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. Service performed by non-authorized personnel may affect to
recording data and result in possible incorrect treatment. The warranty is void if the
Collare or its parts are opened.
-Patient is not allowed to perform maintenance. Only healthcare professionals are
allowed to perform maintenance operations.
-Use of accessories, transducers and cables other than specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emission or
decreased electromagnetic immunity of this equipment and result in improper
operation.
-Make sure that Collare and its parts are not damaged. Using damaged Collare or its
parts may cause wrong diagnosis or patient injury.

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-Do not use Collare and its parts during radiography/X-ray studies.
-Check the approved environmental conditions before transport / usage
-Do not use Collare and its parts in rain.
-It is not allowed to transport Collare and its parts without the specified carrying case.
-When using the Collare in the home, avoid exposing it to lint and dust.
-When using Collare in the home, keep away from the pets.
-Collare is compliance with biocompatibility IEC 10993-1 but using the device may
cause temporary allergic reaction, rash or irritation. If symptoms persist contact your
healthcare professional. To avoid rash, make sure that patient skin is clean and avoid
free from cream.
-Do not bend or stretch 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 Collare and its parts away from children. Children should not in any
circumstances wear the Collare and its parts.
-As with all medical equipment, carefully route cables and connections to reduce the
possibility of entanglement or strangulation.
-Make sure that Collare and its parts are not damaged. Using damaged Collare or its
parts may cause wrong diagnosis or patient injury.
-The Collare system is not certified to be used for continuous monitoring where failure
to operate can cause injuries or death of the patient. Collare is intended to be used
for measuring approximately 10 hours.
-No modification of this equipment is allowed.
-It is prohibited to connect Collare or its parts any other devices than provided.

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1.5. SYMBOLS
The CE mark on this product indicates it has been tested and
conforms to the provisions noted within the 93/42/EEC Medical
Device Directive. CE mark with notified body identification number
indicates a class IIa product.
Manufacturer –Name and the address of the manufacturer. 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 operational, storage and
transportation temperature limits.
Do not re-use –SpO2 sensor is disposable, not not re-use it
Disposal information - European directive on waste electrical and
electronic equipment (WEEE) 2012/19/EU specifies the disposal.
Non-ionizing electromagnetic radiation –Collare has wireless
connection.

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Number of packages –Symbol contains information amount of
packages
Humidity limitations - Collare has humidity limitations
Atmospheric limitations - Collare has atmospheric limitations
This way Up –Indicates that packages needs to be transferred in right
position
Refer to instruction manual/booklet –Read instruction for use before
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 system applied parts: Collare with battery- and measurement
module and pulse oximeter with sensor.
Caution - Indicates a situation which could result in device harm,
damage or malfunction if the appropriate precautions are not followed.
IP22
Degree of protection - The product with carrying case is protected
against harmful effects of dripping water per IES 60529.