CARITAL NeoICU User manual

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KOHJ-H-13-EN1-2.0-19042022
User’s guide
NeoICU
NeoIW

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KOHJ-H-13-EN1-2.0-19042022
Table of contents
1 Description of symbols used 4
1.1 Device and packaging symbols 4
1.2 Symbols on the controller’s operating panel 5
2 Introduction 6
2.1 Intended use and target patients 6
 2.2Operatingenvironmentanduserprole 6
2.3 Indications 6
2.4 Contraindications 6
2.5 System description 6
2.6 Products whose use is described in this guide 7
2.7 Warnings 7
3 Support surface options and covers 11
3.1 NeoICU support surfaces 11
3.1.1 Standard 11
  3.1.2Girae 11
3.2 NeoIW support surface 12
3.3 Medicase®hygiene cover 13
3.3.1 Removing the cover 13
3.3.2 Putting on the cover 15
4 Commissioning 17
4.1 Components of the mattress system 17
4.2 Placing the mattress system onto the incubator 19
4.3 Commissioning the controller 20
4.4 Lifting the controller 22
4.5 Things to check before use 22
5 Operation 23
5.1 Turning on the controller and selecting the weight category 23
 5.2Turningothecontroller 24
5.3 Keypad lock 24
5.4 Operating the controller using battery power 25
5.5 Resuscitation situations 26
5.6 Fault situations 26

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KOHJ-H-13-EN1-2.0-19042022
6 Information signals 27
6.1 Pressure sensor function error 28
6.2 Check the air tubes (leak in tube or cell system) 28
6.3 Pressure target value invalid 29
6.4 SD card operating error 29
6.5 Scheduled maintenance notices 30
6.6 Electromagnetic interference and display information fault situations 31
6.7 Battery operating error 31
6.8 Low battery charge level 32
6.9 Device internal error 33
6.10 Weight category not selected within time limit 33
7 Maintenance and storage 35
7.1 Cleaning 35
7.1.1 Controller and tube system 35
7.1.2 Cells 35
7.1.3 Medicase®hygiene cover 35
7.1.4 Foam plastic supports 36
7.2 Checking the operability of the mattress system 36
7.2.1 Controller 36
7.2.2 Cover 36
7.2.3 Cells 37
7.2.4 Life cycle of the mattress system 37
7.3 Scheduled maintenance 37
7.3.1 Scheduled maintenance interval 37
7.3.2 Checking the maintenance data in the controller’s maintenance view 38
7.4 Storage and transport 38
8 Disposal 40
8.1 Controller 40
8.2 Cells and cover 40
8.3 Packaging 40
9 Warranty 40
10 Technical specications 41
11 Contact details of the manufacturer and service 43
Appendices 44

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KOHJ-H-13-EN1-2.0-19042022
1 Description of symbols used
1.1 Device and packaging symbols
Manufacturer
Date of
manufacture
(yymmdd)
Double
insulated
device
Class I medical
device under
the Medical
Device
Regulation
2017/745 (MDR)
Main fuse
information
Keep
protected
from rain
Fragile, handle
with care
Do not use if
the packaging is
damaged or has
been opened
Store away
from heat
See user’s guide
Type BF device
Allowable
air humidity
limits
Device IP class
Product code
Serial number
Warning
The device
must be
disposed of
in accordance
with EU
directive
2002/96/EC
(WEEE
Directive)
Allowable
air pressure
limits
Allowable
temperature
limits

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KOHJ-H-13-EN1-2.0-19042022
1.2 Symbols on the controller’s operating panel
The NeoICU panel used as an example.
General functions
LED lights
LED lights indicating information signals and the
adjustmentofdierentadjustmentregions
Operating modes
0-3 kg 3–6 kg
Other
NFC tag location in device
(note: this feature is not yet implemented)
Information signal
acknowledgement
Keypad
lock
Device
standby
button
Mains
connected
Battery
usage
Bluetooth
connection
established
(note: this
feature is not yet
implemented)