novos KR-1000 User manual

1
KR-1000
Baby Radiant Warmer
User Manual

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
WARNING
Registered Information:
This document contains information on which NOVOS assumes the property rights. The information
may not be reproduced in whole or in part unless authorized in writing by NOVOS. This information is
the property of NOVOS, for its intended use only.
NOVOS Tıbbi Cihazlar reserves the right to make changes to the features specified in this document or
to discontinue the related product without making any commitment.
For the most up-to-date information, contact your NOVOS representative.
Repair/Modifications:
Repairs on this device shall only be carried out by NOVOS or Factory Authorized Service Centers.
Information on repairs can be obtained from NOVOS or Authorized Resellers. NOVOS shall not assume
any responsibility for any injury to persons or damage to property arising directly or indirectly from
unauthorized repair or modification of this device. In addition, any unauthorized repair or modification
shall void any warranty provided by NOVOS. This document is provided for information purposes only.
It cannot be changed or updated at will.

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Table of Contents
About This Manual.................................................................................................................................................. 7
1. Safety Information ........................................................................................................................................ 12
1.1. User Obligations for Patient Safety............................................................................................................ 12
1.1.1. Patient Monitoring.............................................................................................................................. 12
1.2. Limitation of Liabilities ............................................................................................................................... 12
1.3. Usage Restrictions...................................................................................................................................... 12
1.3.1. Operating ............................................................................................................................................ 13
1.3.2. Power Supply....................................................................................................................................... 13
1.3.3. Servicing .............................................................................................................................................. 13
1.3.4. Cleaning and Maintenance.................................................................................................................. 13
1.3.5. Warnings on Indications, Contraindications, Side Effects, Adverse Effects and Possible Physiological
Effects............................................................................................................................................................ 13
1.3.6. Warnings for the Use of the Device .................................................................................................... 14
1.3.7. Bearing Capacity.................................................................................................................................. 15
1.3.8. EMC Restrictions ................................................................................................................................. 16
1.3.9. Restrictions of the Environment in which the Device will be Used..................................................... 16
1.3.10. Electrical Safety Restrictions ............................................................................................................. 16
1.3.11. Transportation Restrictions............................................................................................................... 17
1.4. Warranty .................................................................................................................................................... 18
2. Product Description ...................................................................................................................................... 19
2.1. Usage Purpose............................................................................................................................................ 19
2.2. Patient Population...................................................................................................................................... 19
2.3. Life Cycle .................................................................................................................................................... 19
2.4. Main Functions........................................................................................................................................... 19
2.5. Controls and Gauges .................................................................................................................................. 21
2.5.1. Overview to Control Panel .................................................................................................................. 22
2.5.2. Balance Control Unit ........................................................................................................................... 25
2.5.3. Easypuff Resuscitation Device (Optional) ........................................................................................... 29
2.5.4. Bililed Mini+ Phototherapy (Optional) ................................................................................................ 29
2.5.5. Trendelenburg Control Unit ................................................................................................................ 30
2.5.6. Power Input......................................................................................................................................... 31
2.5.7. Auxiliary Power Socket........................................................................................................................ 31
2.5.8. Height Adjustment Pedals (Optional).................................................................................................. 32
2.6. Other Mechanical Components ................................................................................................................. 33
2.7. Warmer Head............................................................................................................................................. 33
2.7.1. IV Pole (Optional) ................................................................................................................................ 33
2.7.2. Monitor Tray (Optional) ...................................................................................................................... 34

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
2.7.3. Accessory Mounting Rail (Optional).................................................................................................... 34
2.7.4. Power Cable Coil ................................................................................................................................. 35
2.7.5. Acrylic Protective Panels ..................................................................................................................... 35
2.7.6. Rotating Bed (Optional)....................................................................................................................... 35
2.7.7. X-Ray Tray............................................................................................................................................ 36
2.7.8. E Cylinder Slots (Optional)................................................................................................................... 36
2.7.9. Accessory Hanger................................................................................................................................ 36
2.7.10. Rotating Drawer (Optional)............................................................................................................... 37
2.7.11. Auxiliary Tray (Optional) ................................................................................................................... 37
2.7.12. Wheel Locks ...................................................................................................................................... 38
2.8. Temperature Sensors................................................................................................................................. 38
2.8.1. Skin Probe ........................................................................................................................................... 38
2.8.2. Air Probe ............................................................................................................................................. 39
3. Operating Procedure..................................................................................................................................... 40
3.1. Installation.................................................................................................................................................. 40
3.2. Pre-Start Check........................................................................................................................................... 44
3.2.1. Alarm System Check............................................................................................................................ 44
3.2.2. Control Panel Check ............................................................................................................................ 46
3.3. Preparation ................................................................................................................................................ 47
3.4. Essential Use .............................................................................................................................................. 49
3.4.1. Operating Device................................................................................................................................. 49
3.4.2. Placing/Removing Skin Probe.............................................................................................................. 50
3.4.3. Operation Modes ................................................................................................................................ 51
3.5. Alarms ........................................................................................................................................................ 56
4. Troubleshooting ............................................................................................................................................ 58
4.1. Fast Troubleshooting Guide ....................................................................................................................... 58
5. Routine Cleaning and Maintenance.............................................................................................................. 59
5.1. General Cleaning ........................................................................................................................................ 59
5.1.1. Cleaning Skin Probe............................................................................................................................. 60
5.1.2. Cleaning of Baby Bed........................................................................................................................... 60
5.1.3. Approved Solutions............................................................................................................................. 60
5.1.4. After Cleaning...................................................................................................................................... 61
5.2. Maintenance .............................................................................................................................................. 61
5.2.1. General Maintenance.......................................................................................................................... 61
6. Easypuff T-Piece Resuscitation (Optional) .................................................................................................... 63
6.1. Usage Purpose............................................................................................................................................ 63
6.2. User’s Responsibilities for Patient Safety................................................................................................... 63
6.3. Usage Restrictions...................................................................................................................................... 63

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
6.4. Preparation ................................................................................................................................................ 64
6.5. Operating ................................................................................................................................................... 70
6.6. Cleaning and Maintenance......................................................................................................................... 70
7. Bililed Mini+ Phototherapy Unit (Optional) .................................................................................................. 71
7.1. Usage Purpose............................................................................................................................................ 71
7.2. User’s Responsibilities for Patient Safety................................................................................................... 71
7.3. Use Restrictions.......................................................................................................................................... 72
7.4. Preparation ................................................................................................................................................ 72
7.4.1. Placement of the Bililed Mini+ ............................................................................................................ 72
7.4.2. Power Supply Connection ................................................................................................................... 73
7.5. Operating ................................................................................................................................................... 74
7.5.1. Phototherapy Operation ..................................................................................................................... 74
7.5.2. Use of Examination Lamps .................................................................................................................. 81
7.6. Cleaning and Maintenance......................................................................................................................... 83
7.6.1. Cleaning............................................................................................................................................... 83
7.6.2. Maintenance ....................................................................................................................................... 85
8. Venturi Vacuum Unit (Optional) ................................................................................................................... 86
8.1. Usage Purpose............................................................................................................................................ 86
8.2. User’s Responsibilities for Patient Safety................................................................................................... 86
8.3. Operating ................................................................................................................................................... 87
8.4. Cleaning and Maintenance......................................................................................................................... 87
8.4.1. Venturi Vacuum Unit........................................................................................................................... 87
8.4.2. Collection Container............................................................................................................................ 87
8.5. Technical Specifications ............................................................................................................................. 88
9. Annexes......................................................................................................................................................... 89
9.1. Technical Specifications ............................................................................................................................. 89
9.1.1. Environmental Properties ................................................................................................................... 89
9.1.2. Mechanical Properties ........................................................................................................................ 89
9.1.3. Characteristic Properties..................................................................................................................... 89
9.1.4. Other Properties.................................................................................................................................. 90
9.1.5. Accessories and Consumables............................................................................................................. 91
9.2. Compatibility .............................................................................................................................................. 92
9.3. Guidance and Manufacturer's Declaration of Electromagnetic Compatibility .......................................... 93
9.3.1. Electromagnetic Environment............................................................................................................. 93
9.3.2. Electromagnetic Immunity.................................................................................................................. 94
9.3.3. Recommended Separation Distance................................................................................................... 97
9.4. Equipment Classifications .......................................................................................................................... 98
9.5. Trademark Registrations ............................................................................................................................ 98

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
9.6. Manufacturer ............................................................................................................................................. 98

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
About This Manual
Scope:
This manual contains a detailed description of all sub-components, use and care details of the KR-
1000 Baby Radiant Warmer System.
Target Users:
This device should only be used by medical personnel trained in the operation of the device who are
aware of all the risks and benefits of the operation of such devices.
The intended users of this guide are end users of the device, healthcare providers in delivery rooms
and neonatal intensive care units, and hospitals’ biomedical and clinical engineering services.
The product is intended for professional use.
Aim:
This manual is a guide to the following items of the KR-1000 Baby Radiant Warmer System:
•Installation
•Usage
•Maintenance
All features and technical information of the device are listed considering the user benefit in order to
facilitate the efficient use of the device.

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Symbols
This symbol means "Attention, see relevant documentation" and may
appear on any hardware component of the device.
This symbol means the device is in the BF class.
This symbol is used to warn the users of the device against possible risk
or injury. Warnings are instructions that, if not followed, could result in
fatal or serious injury to a user, engineer, patient, or other person, or
could result in improper treatment.
ATTENTION
These are the guidances that may damage the system as described in this
manual, if the attention notes are not followed.
NOTE:
NOTE is used where additional information on the subject is given.
Hot Surface
AC power available
AC power not available
Celsius/Fahrenheit switch
Remote alarm silencer
Alarm silencer button
Setting button for target temperature above 37 °C
Examination light on/off button
Numpad light on/off button
Save/delete button
Weight records difference button
Reset Trendelenburg button
First save button for Trendelenburg
Second save button for Trendelenburg

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Trendelenburg position button
Reverse Trendelenburg position button
ID
Product ID.
Manufacturer.
Input voltage.
Date of Manufacture.
Electrical and electronic equipment waste should not be disposed of in
general municipal waste, but should be collected separately.
SN
Serial number.
Power.
Fuse Box
CE mark Authorized body
Storage temperature and moisture
Operation temperature and moisture

Novos KR-1000 Baby Radiant Warmer User Manual
NVS.S9.KK04 / Rev.06 / 27.07.2021
Labels on the Device
Product
Identity
Technical
Service
Warning
Outer Box
Label