CARITAL NeoICU User manual

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User’s guide
NeoICU
NeoIW

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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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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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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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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)

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2 Introduction
2.1 Intended use and target patients
A mattress system for the prevention and treatment of pressure ulcers in prematurely
born patients (> 500 g) with high and very high risk of pressure ulcers or in newborn pa-
tients, i.e. in mature infants under 28 days of age and older children weighing up to 6 kg.
2.2Operatingenvironmentanduserprole
Intended for use in incubators (NeoICU) as well as in neonate warmers and baby stations
(NeoIW) in professional healthcare environments (standard wards and intensive care).
The user can be a healthcare professional who has read the user’s guide and understands
the basic operating principle and use of the mattress system.
2.3 Indications
The indications include use in healthcare for the patient group mentioned in section 2.1
– in the treatment and prevention of pressure ulcers in burn patients
– in the prevention of pressure ulcers in special patient groups, such as patients who
undergo extracorporeal membrane oxygenation (ECMO) or therapeutic hypothermia
or who have spinal or other severe or unstable fractures
 –inthetreatmentofpressureulcers,regardlessoftheclassicationorstage(I–IV)of
thepressureulcer,includingstagenon-speciculcers/injuries.
The devices are also indicated for pain management in the above-mentioned patients.
2.4 Contraindications
No known contraindications.
2.5 System description
Carital®NeoICU and NeoIW mattress systems have tunnel-shaped cells that adjust to the
body of the patient. The cells are interconnected, forming three separate adjustment
regions(head,torso,feet).Allcellsrespondtotheweight,prole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 a patient.
The Carital®principle: Maximizes contact area,
minimizes contact pressure and tissue deformation.
Operating principle of Carital®: maximizes contact surface area, minimizes contact pressure and tissue deformation
1. Initial situation 2. Adjusted mattress 3. Shape of the adjusted mattress with no patient
IET-H-01-1.1-en

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2.6 Products whose use is described in this guide
• NeoICU controller and cells
• NeoIW controller and cells
• Medicase®hygiene cover
This guide applies only to second-generation Carital®controllers.
A second-generation controller can be identied by a serial number
beginning with the PC identier.
Serious incidents related to the medical devices described in the
user’s guide that directly or indirectly resulted in, could have re-
sulted in or could result in 1) death of a patient, user or other
person 2) serious or permanent deterioration in the health of a pa-
tient, user or other person 3) serious threat to public health must
be immediately reported to the manufacturer and the Medicines
and Healthcare products Regulatory Agency (MHRA).
Read this guide carefully before commissioning 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.
2.7 Warnings
• This guide applies only to second-generation Carital®controllers. A second-generation
controllercanbeidentiedwithitsserialnumberbeginningwiththePCidentier.
• Only a healthcare professional can assess the need and suitability of using the mat-
tress system in a treatment situation.
• Serious incidents related to the medical devices described in the user’s guide that
directly or indirectly resulted in, could have resulted in or could result in 1) death of
a patient, user or other person 2) serious or permanent deterioration in the health
of a patient, user or other person 3) serious threat to public health must be immedi-
ately reported to the manufacturer and and the Medicines and Healthcare products
Regulatory Agency (MHRA).
• 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
distributor.

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• Donotusethedeviceifthecongurationisincompleteoranyofitscomponentsis
broken, worn or contaminated. Worn, missing and broken parts must be replaced
and contaminated ones cleaned.
• Do not modify the mattress system and do not connect the mattress system to other
deviceswithoutthemanufacturer’spermission.Unauthorisedmodications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 use or resulting from maintenance, repair or
modication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
until it has been at room temperature (ca. +20 °C) for at least two hours. This time
is required for all components of the controller to reach the normal recommended
operating temperature (+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 cause suf-
focation. Make sure that the air tubes and the controller’s power cable cannot twist
around the head or neck.
• The power cable of the controller must be positioned in such a way that it cannot be
clamped, for example, by the folding parts of the incubator under any circumstances.
• Ensure that the power cable is plugged into its mains outlet in such a way that it does
not present a risk of stumbling.
• The power cable of the controller must always be plugged into the outlet, excluding
short patient transports or similar situations.
• To maintain the battery’s performance, keep the controller continuously connected
to the mains 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deate.
• Never use the mattress system without a cover on the cells.
• Do not use extra sheets, pillows or heavy position supports on the mattress system.

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• A healthcare professional needs to assess the suitability of and need for the womb
substitute system (WSS) separately in each treatment situation.
• Before placing the patient on the support surface, start the device as described in
section 5.1, and allow the mattress system to adjust to the desired weight category
successfully, so that all green LEDs are lit in the centre of the LED light bar.
• The size of the support surface should correspond to the size of the patient for the
optimal adjustment of the pressure values in all parts of the support surface which
correspondtodierentbodyparts.
• Before evacuation, disconnect the controller’s power cable from the mains and the
air tubes from the controller.
• Whenresuscitating,turnothedevicefromthestandbybuttonandstartCPRim-
mediatelywithoutdeatingthecells.
• Do not immerse the controller in any 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 support surface 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.
• The foam plastic supports must not be washed.
• Ifthesupportsurfaceisusedinviolationoftheinstructionsspecied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 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
conguration,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.

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• Usingaccessories,transformersorcablesotherthanthosespeciedbythemanufac-
turer or supplied with the device may result in elevated electromagnetic emissions
orreducedelectromagneticimmunityandhaveadverseeectontheperformance
of the controller for its intended use.
• 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speciedinthetechnicallesofthe
controller.
• The controller is intended for long-term use. However, the controller has compo-
nents which may break if the controller is subjected to an impact, force or shake
that exceeds the design standards. The limited manufacturer warranty does not
apply to situations where the product has been mishandled.
• The rechargeable or non-rechargeable batteries may only be replaced by Carital®
service. Incorrect battery replacement 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ocialregulationspertainingtocontaminated
healthcare waste.
• If the controller has encountered a signicant 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useorresultingfrommaintenance,repairormodication
carried out by a party other than Carital®service.
• If the mattress system does not behave in accordance with the functions and situ-
ations described in this manual, disconnect the air tubing from the tube system of
thecellsandthepowercablefromthecontroller,turnothe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
service.
• Scheduled maintenance may only be carried out by Carital®service.