novos KI 1000 User manual

NVS.S9.KK01/Rev.06/06.04.2021
KI 1000
User Manual

NVS.S9.KK01/Rev.06/06.04.2021
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. These information are the property of
NOVOS, for its intended use only.
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.

NVS.S9.KK01/Rev.06/06.04.2021
Table of Contents
About This Manual ..........................................................................................................................................................1
1. Safety Information.................................................................................................................................................5
1.1. User Obligations for Patient Safety ...................................................................................................................... 5
1.1.1. Patient Monitoring ..................................................................................................................................... 5
1.2. Limitation of Liabilities ......................................................................................................................................... 5
1.3. Usage Restrictions ................................................................................................................................................ 6
1.3.1. Operating........................................................................................................................................................ 6
1.3.2. Power Supply.............................................................................................................................................. 6
1.3.3. Servicing ..................................................................................................................................................... 6
1.3.4. Cleaning and Maintenance......................................................................................................................... 6
1.3.6. Warnings for the Use of the Device............................................................................................................ 7
1.3.7. Bearing Capacity ....................................................................................................................................... 11
1.3.9. Restrictions of the Environment in which the Device will be Used.......................................................... 11
ATTENTION............................................................................................................................................................. 11
1.3.10. Electrical Safety Restrictions .............................................................................................................. 11
1.3.11. Transportation Restrictions................................................................................................................ 12
1.4. Warranty ............................................................................................................................................................ 13
2. Product Description.............................................................................................................................................14
2.1. Usage Purpose.................................................................................................................................................... 14
2.2. Patient Population.............................................................................................................................................. 14
2.3. Life Cycle............................................................................................................................................................. 14
2.4. Main Functions................................................................................................................................................... 15
2.5. Product Parts and Controls................................................................................................................................. 16
2.5.1.Front View ..................................................................................................................................................... 16
2.5.2. Side and Rear View................................................................................................................................... 17
2.5.3. Control Panel Connections ....................................................................................................................... 18
3. General Overview................................................................................................................................................19
3.1. Control Panel...................................................................................................................................................... 19
Knob Button: .......................................................................................................................................................... 19
3.2. Sensors ............................................................................................................................................................... 20
3.2.1. Temperature Sensors ............................................................................................................................... 20
3.2.2. Oxygen/Humidity Sensor Module ............................................................................................................ 21
3.3. TTSS (Target Temperature Surveillance System)................................................................................................ 21
3.4. Canopy................................................................................................................................................................ 22
3.4.1.Front/Rear Access Covers.............................................................................................................................. 18
3.4.3.Double Wall ................................................................................................................................................... 19

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3.4.4.Grommets...................................................................................................................................................... 22
3.5. Baby Bed............................................................................................................................................................. 23
3.6. X-Ray Tray........................................................................................................................................................... 25
3.7. Smart Weighing System (Optional) .................................................................................................................... 25
3.8. Drawers and Cabinet .......................................................................................................................................... 26
3.9. Height Adjustment System (Optional)................................................................................................................ 26
3.10. IV Pole (Optional) ..................................................................................................................................... 27
3.11. Wheel Brakes............................................................................................................................................ 28
3.12. Humidification System.............................................................................................................................. 29
3.12.1. Filling the Water Reservoir ................................................................................................................. 29
3.13. O2System ................................................................................................................................................. 30
3.13.1. Oxygen Inlet Connection .................................................................................................................... 30
3.13.2. Changing Oxygen Cells........................................................................................................................ 31
4. Preparation..........................................................................................................................................................32
4.1. Unpacking and First Installation ......................................................................................................................... 32
5. Use of Device.......................................................................................................................................................38
5.1. Operating KI 1000............................................................................................................................................... 38
5.2. Main Display....................................................................................................................................................... 39
5.2.1. Control Boxes............................................................................................................................................ 40
5.3. Use in Air Mode.................................................................................................................................................. 41
5.3.1. Setting the Air Temperature Target Value ............................................................................................... 41
5.3.2. Setting TTSS Target Skin Temperature ..................................................................................................... 42
5.3.3. Setting Extended Air Temperature Target Point ...................................................................................... 43
5.3.4. Reducing Air Temperature Inside the Canopy.......................................................................................... 43
5.3.5. Air Mode Alarms....................................................................................................................................... 44
5.4. Use in Skin Mode................................................................................................................................................ 44
5.4.1. Attaching/Detaching the Skin Probe ........................................................................................................ 44
5.4.2. Checking the Function of the Temperature Sensors ................................................................................ 45
5.4.3. Setting the Skin Temperature Target Value ............................................................................................. 47
5.4.4. Setting TTSS Target Air Temperature ....................................................................................................... 48
5.4.5. Setting Extended Skin Temperature Target Point .................................................................................... 48
5.4.6. Skin Mode Alarms..................................................................................................................................... 49
5.5. Use of Servo Humidity........................................................................................................................................ 51
5.5.1. Setting Humidity Target Point .................................................................................................................. 51
5.5.2. Humidity Mode Alarms............................................................................................................................. 52
5.6. Use of Servo O2................................................................................................................................................... 53
5.6.1. Setting O2Concentration in Manual Flow Controlled O2System............................................................. 53
5.6.2. Setting the Oxygen Target Point on the Servo Controlled Oxygen System.............................................. 53

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5.6.3. Setting the Expanded Oxygen Concentration Target Point ...................................................................... 54
5.6.4. Calibration of Oxygen Sensors.................................................................................................................. 55
5.6.5. Oxygen Mode Alarms ............................................................................................................................... 57
5.7. Use of Smart Weighing Option........................................................................................................................... 58
5.7.1. Starting the Weighing Procedure ............................................................................................................. 58
5.8. Alarms and Warnings ......................................................................................................................................... 60
5.9. Trend Indication ................................................................................................................................................. 61
5.9.1. Setting the Graphic Type and Duration (Zoom)........................................................................................ 62
5.10. Patient History Records ............................................................................................................................ 63
5.10.1. Viewing Patient History ...................................................................................................................... 63
5.11. Standby Mode .......................................................................................................................................... 65
5.12. Selecting Accessible Modes...................................................................................................................... 66
5.13. Settings..................................................................................................................................................... 67
5.13.1. Configuring Date/Time Settings ......................................................................................................... 68
5.13.2. Configuring System Settings............................................................................................................... 69
5.13.3. Configuring Alarm Settings................................................................................................................. 69
5.13.4. Service Settings................................................................................................................................... 70
5.14. Screen Lock............................................................................................................................................... 70
5.15. Height Adjustment.................................................................................................................................... 71
5.16. Shutting Down KI 1000 ............................................................................................................................. 72
6. Routine Cleaning and Maintenance ....................................................................................................................73
6.1. Cleaning and Disinfection................................................................................................................................... 73
6.1.1. Measures ...................................................................................................................................................... 73
6.1.2. Removal of Incubator Components for Cleaning Purposes...................................................................... 74
6.1.3. Cleaning and Disinfection Procedure ....................................................................................................... 76
6.1.4. Changing Air Filter .................................................................................................................................... 77
6.1.5. Cleaning Skin Probe .................................................................................................................................. 80
6.2. Maintenance List ................................................................................................................................................ 81
6.3. Disposal of the Incubator ................................................................................................................................... 81
6.3.1. Disposal of the Air Filter ........................................................................................................................... 81
6.3.2. Disposal of the O2Sensors........................................................................................................................ 81
6.3.3. Disposal of the Incubator ......................................................................................................................... 81
7. Troubleshooting ..................................................................................................................................................82
7.1. Error Messages................................................................................................................................................... 82
8. Annexes...............................................................................................................................................................83
8.1. Technical Specifications...................................................................................................................................... 83
8.1.1. Device Classification ................................................................................................................................. 83
8.1.2. Environmental Requirements....................................................................................................................... 83
8.1.3. Electrical Properties.................................................................................................................................. 83

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8.1.4. Mechanical Properties.............................................................................................................................. 83
8.1.5. Sensor Features ........................................................................................................................................ 84
8.1.6. Servo Humidity Features .......................................................................................................................... 85
8.1.7. Alarm Features ......................................................................................................................................... 85
8.1.8. Other Properties....................................................................................................................................... 85
8.2. Compatibility ...................................................................................................................................................... 87
8.2.1. Compliance Directive:............................................................................................................................... 88
8.2.2. Guidance and Manufacturer's declaration - Electromagnetic Emissions................................................. 89
8.3. Trademark Registrations .................................................................................................................................... 93
8.4. Manufacturer ..................................................................................................................................................... 93

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About This Manual
Scope:
This manual contains a detailed description of all sub-components, use and care details of the KI 1000 infant
incubator.
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 guide is a guide to:
• Installation
• Usage
• Maintenance
of the KI 1000 infant incubator. All features and technical information of the device are listed considering the
user benefit in order to facilitate the efficient use of the device.
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.
IP20
Protected against solid objects larger than 12.5 mm.
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.
ID
Product ID
Manufacturer

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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
See User Manual
Protective Grounding
Alternative Current
This sign on the label indicates that the package should stand upright.
This sign on the label indicates that the contents of the package are
fragile and should be handled with care.
This sign on the label indicates that the package must be protected from
moisture and rain.
Storage temperature and moisture
Operation temperature and moisture

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Label Information:
Product Identity
Technical Service
Warning
Outer Box Label

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Reusable Skin
Probe Label
Disposable Skin
Probe Label