CARITAL NeoICU User manual

1
KOHJ-H-13-EN1-1.1-30112021
User’s guide
NeoICU

2
KOHJ-H-13-EN1-1.1-30112021
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 purpose and target patients 6
2.2 Operating environment and user profile 6
2.3 Contraindications 6
2.4 System description 6
2.5 Products whose use is described in this guide 6
2.6 Warnings 7
3 Covers and support services 11
3.1 Medicase®hygiene cover 11
3.2 Giraffe support surface 11
3.3 Taking offthe cover 12
3.4 Putting on the cover 14
4 Commissioning 16
4.1 Components of the mattress system 16
4.2 Placing the mattress system onto the incubator 18
4.3 Commissioning the controller 19
4.4 Lifting the controller 21
4.5 Things to check before use 21
5 Operation 23
5.1 Turning on the controller and activating the weight class 23
5.2 Turning offthe 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
6 Information signals 27
6.1 Pressure sensor function error 28
6.2 Check the air tubes (leak in tube or cells) 28
6.3 Pressure target value invalid 29
6.4 SD card operating error 30
6.5 Scheduled maintenance notices 30
6.6 Electromagnetic interference and display information fault situations 31
6.7 Battery operating error 31
6.8 Battery charge falls low 32
6.9 Device internal error 33

3
KOHJ-H-13-EN1-1.1-30112021
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®cover 35
7.1.4 Foam inserts 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 36
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 37
7.4 Storage and transport 38
8 Disposal 39
8.1 Controller 39
8.2 Cells and cover 40
8.3 Packaging 40
9 Warranty 40
10 Technical specifications 41
11 Contact details of the manufacturer and service 42
Appendices 43

4
KOHJ-H-13-EN1-1.1-30112021
1 Description of symbols used
1.1 Device and packaging symbols
Manufacturer
Date of
manufacture
(yymmdd)
Double
insulated
device
Class 1 medical
device under
the EU Medical
Device Regula-
tion 2017/745
(MDR)
Main fuse infor-
mation
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
Permitted air humid-
ity limits
Device IP class
Product code
Serial number
Warning
The device
must be dis-
posed of in
accordance
with EU di-
rective
2002/96/EC
(WEEE Direc-
tive).
Allowable
air pressure
limits
Allowable
temperature
limits

5
KOHJ-H-13-EN1-1.1-30112021
1.2 Symbols on the controller’s operating panel
General functions
Device
standby
button
LED lights
Mains connected
LED lights indicating information signals
and the adjustment of different adjust-
ment regions
Operating modes
0-3 kg
Other
NFC tag location in device (note: this feature is not yet implemented)
Keypad lock
Battery usage
3-6 kg
Acknowledge-
ment of infor-
mation signal
Bluetooth con-
nection estab-
lished (note:
this feature is
not yet imple-
mented)

6
KOHJ-H-13-EN1-1.1-30112021
2 Introduction
2.1 Intended purpose and target patients
Carital®NeoICU is a specialty mattress for prevention of pressure ulcers in high-risk and
extreme-high-risk prematurely born children (> 500 g) or in neonates i.e. a full term in-
fants under 28 days of age and older children up to the weight of 6 kg.
2.2 Operating environment and user profile
The Carital®NeoICU is intended for healthcare environments (regular wards and inten-
sive care).
The user can be a healthcare professional that has read the user’s guide and understands
the basic operating principle and use of the mattress system.
2.3 Contraindications
No known contraindications.
2.4 System description
The Carital®NeoICU mattress system has tunnel-shaped cells that adjust to the patient’s
body. The cells form three separate adjustment regions (head, torso, feet). All cells re-
spond to the weight, profile and position of the body, distributing the load evenly across
all cells.
1. Initial situation 2. Adjusted mattress 3.The shape of an adjusted
mattress without the patient.
The Carital®principle: Maximizes contact area,
minimizes contact pressure and tissue deformation.
2.5 Products whose use is described in this guide
• NeoICU controller and cells
• Medicase®hygiene cover

7
KOHJ-H-13-EN1-1.1-30112021
This guide applies only to second-generation Carital®controllers. A
second-generation controller can be identified with its serial num-
ber beginning with the PC identifier.
Any serious incident that has occurred in relation to the device
described in the user’s guide that directly or indirectly led, might
have led or might lead to any of the following: (a) the death of a pa-
tient, user or other person, (b) the temporary or permanent serious
deterioration of a patient’s, user’s or other person’s state of health,
(c) a serious public health threat; should be reported to the manu-
facturer and the competent authority of the Member or Sovereign
State in which the user and/or patient is established.
Read this guide carefully before starting to use the mattress system.
Persons who have not read this user’s guide or cannot understand
its content may not operate the mattress system independently.
Keep this guide.
2.6 Warnings
• This guide applies only to second-generation Carital®controllers. A second-genera-
tion controller can be identified with its serial number beginning with the PC iden-
tifier.
• Only healthcare professionals can assess the need for and suitability of a mattress
system in the treatment situation.
• Any serious incident that has occurred in relation to the device described in the
user’s guide that directly or indirectly led, might have led or might lead to any of
the following: (a) the death of a patient, user or other person, (b) the temporary
or permanent serious deterioration of a patient’s, user’s or other person’s state of
health, (c) a serious public health threat; should be reported to the manufacturer
and the competent authority of the Member or Sovereign State in which the user
and/or patient is established.
• If you have any questions regarding the commissioning, use or maintenance of the
mattress system or if you notice that the device works in an unanticipated way or a
way not described in this guide, contact the mattress system’s reseller.
• Contact the mattress system’s reseller if any part of the mattress system is damaged
or works in an unusual way. Do not attempt to repair damage before contacting the
reseller.
• Do not use the device if the configuration is incomplete or any of its components is
broken, worn or contaminated. Worn, missing and broken parts must be replaced
and contaminated once cleaned.

8
KOHJ-H-13-EN1-1.1-30112021
• Do not modify the mattress system and do not connect the mattress system to other
devices without the manufacturer’s permission. Unauthorised modifications and con-
nections may pose a danger to the user of the mattress system.
• The user is responsible for any and all consequences of the use of the device in a
manner inconsistent with its intended purpose or resulting from maintenance, repair
or modification carried out by a party other than Carital®service.
• Use only original Carital®spare parts and accessories.
• The temperature of the controller may have decreased or increased during transport
beyond the limits of the allowable operating temperatures. Do not use the controller
before it has been at room temperature (~ +20°C) for at least two hours. This time
is required for all components of the controller to reach the normal recommended
operating temperature of +10 – +35°C.
• Ensure that the settings of the device do not change unintentionally, for example
because of children or pets. If necessary and the operating environment poses a
risk of inadvertent changes of control operating modes, use the keypad lock in the
controller.
• A twisted air tube or controller power cable around the neck or head may result in
suffocation. Make sure that the air tubes and the controller’s power cable cannot
twist around the head or neck.
• Place the controller’s power cable in such a way that it cannot be clamped in any
situation, for example by the folding parts of the incubator.
• Make sure there is no risk of tripping over the connected power cable.
• The power cable of the controller must always be plugged into the outlet, excluding
short patient transports or similar situations.
• To maintain battery performance, connect the controller to AC power continuously
for 12 hours at least every three (3) months.
• Always place the controller in such a way that it can easily be disconnected from
the mains. Ensure that the control panel and connectors of the controller are always
accessible.
• If the Sixtube connector of the air tube system is disconnected from the controller,
the cells will deflate.
• Never use the mattress system without a cover on the cells.
• Do not use extra bed sheets, pillows or heavy positioning pillows on the mattress
system.
• The placement of WSS in a treatment situation must be done according to a separate
assessment by a health care professional.

9
KOHJ-H-13-EN1-1.1-30112021
• Before placing the patient on the mattress, start the device as described in section
5.1, and allow the mattress system to adjust to the selected weight class successful-
ly, so that all green LEDs are lit in the centre of the LED light bar.
• The dimensions of the mattress should always fit to the size of the patient, such that
the pressure in all the adjustment sections are optimally placed to be regulated by
the controller in correspondence to the patient’s body parts.
• Before evacuation, disconnect the controller’s power cable from the mains.
• When resuscitating, turn offthe device from the standby button and start CPR im-
mediately without deflating the cells.
• Do not immerse the controller in liquid.
• Do not cover the controller while in operation.
• Be sure to put the quick guide caddy back in place after examination.
• Do not lift the mattress by holding the cells or the cover.
• Sharp objects may puncture the cells.
• If the cover or cells are exposed to urea (sweat and urine) for a prolonged period,
the molecular structure of polyurethane may break down, damaging the cover or the
cells. Clean the cover and/or cells immediately if exposed to urea.
• Do not clean the plastic parts of the mattress system using solvents, phenols or clean
alcohols.
• Ensure that the cover is entirely dry before commissioning it.
• Do not wash the foam inserts.
• If the mattress is used in violation of the instructions specified in the user’s guide,
or it is not cleaned of body secretions containing urea in particular, or the mattress
system is used by a prominently sweating or mobile patient, the estimated life cycle
of the cover and the cells may be shortened.
• Do not store anything on top of the mattress system.
• Do not place sharp or heavy objects on or near the mattress system.
• Keep the controller away from heat sources.
• Avoid using the controller in the proximity of other electric devices or in a stacked
configuration, as this may interfere with the controller’s operation. If the above use
is necessary, ensure the normal operation of the controller by monitoring it.
• Using accessories, transformers or cables other than those specified by the manufac-
turer or supplied with the device may result in elevated electromagnetic emissions
or reduced electromagnetic immunity and have adverse effect on the performance
of the controller for its intended purpose.

10
KOHJ-H-13-EN1-1.1-30112021
• The distance of portable devices communicating using radio frequencies (including
antenna cables and external antennas) to the controller and its cables should be at
least 30 cm so as to ensure the performance specified in the technical files of the
controller.
• The controller is intended for long-term use. However, it contains components that
may break if the product is dropped or subjected to impact or vibration exceeding
design standards. The limited manufacturer warranty does not apply to situations
where the product has been mishandled.
• The batteries may only be replaced by Carital®service. Incorrect battery replace-
ment may result in a situation where the device will not work correctly.
• Contaminated components must be cleaned before disposal or, if cleaning is not pos-
sible, disposed of in accordance with official regulations pertaining to contaminated
healthcare waste.
• If the controller has encountered a significant mechanical strain (dropped, hard
collision or similar), check the mechanical condition of the control port's connection
gates and ensure that the seals between the operator panel/frame and the connec-
tion port/base plastic parts and the body are in place. If you notice any damage to
the device, contact Carital®service.
• Maintenance and repair must always be carried out by Carital®service. The user is
responsible for any and all consequences of the use of the device in a manner incon-
sistent with its intended purpose or resulting from maintenance, repair or modifica-
tion carried out by a party other than Carital®service.
• If the mattress system behaves contrary to the functions and situations described
in this user’s manual, disconnect the air tubing from the cell’s tube system and the
power cable from the controller, turn offthe controller, and contact Carital®service.
• The mattress system must always be serviced according to the service programme
described in this guide. A device that has not been serviced in accordance with the
service programme must not be used but must be sent to Carital®service, instead.
The user is responsible for any and all consequences resulting from neglecting ser-
vice.
• Scheduled maintenance may only be carried out by Carital®service.