CARITAL OptimaCot User manual

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KOHJ-H-15-EN1-1.0-15102021
User’s guide
OptimaCot

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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 purpose 6
 2.2Operatingenvironmentanduserprole 6
2.3 Target patients 6
2.4 Contraindications 6
2.5 System description 6
2.6 Products whose use is described in this guide 6
2.7 Warnings 7
3 Covers 11
3.1 Medicase®hygiene cover 11
3.2 Comfort add-on for the Medicase®hygiene cover 12
 3.3Takingothecover 12
3.4 Putting on the cover 13
4 Commissioning 16
4.1 Components of the mattress system 16
4.2 Connecting the mattress system to the bed 18
4.3 Commissioning the controller 20
4.4 Lifting the controller 21
4.5. Things to check before use 22
5 Operation 23
5.1 Turning on the controller and activating Normal operation 23
 5.2Turningothecontroller 24
5.3 Sitting operation 24
5.4 Firm operation 25
5.5 Silent operation 26
5.6 Supine operation 27
5.7 Keypad lock 27
5.8 Operating the controller using battery power 28
5.9 Resuscitation situations 29
5.10 Fault situations 29

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6 Information signals 29
6.1 Pressure sensor function error 30
6.2 Elevated pressure ulcer risk (sitting operation) 31
6.3 Check the air tubes (leak in tube or inner cells) 31
6.4 Pressure target value invalid 32
6.5 SD card operating error 33
6.6 Scheduled maintenance notices 33
6.7 Electromagnetic interference and display information fault situations 34
6.8 Battery operating error 35
6.9 Battery charge falls low 35
6.10 Device internal error 36
7 Maintenance and storage 38
7.1 Cleaning 38
7.1.1 Controller and tube system 38
7.1.2 Cells 38
7.1.3 Medicase®cover 38
7.1.4 Comfort add-on for the cover 39
7.1.5 Foam inserts for the cover 39
7.2 Checking the operability of the mattress system 39
7.2.1 Controller 39
7.2.2 Cover 40
7.2.3 Cells 40
7.2.4 Life cycle of the mattress system 41
7.3 Scheduled maintenance 41
7.3.1 Scheduled maintenance interval 41
7.3.2 Checking the maintenance data in the controller’s maintenance view 42
7.4 Storage and transport 42
8 Disposal 44
8.1 Controller 44
8.2 Cells and cover 44
8.3 Packaging 44
9 Warranty 44
10 Technical specications 45
11 Contact details of the manufacturer and service 47
Appendices 48

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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

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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dierentadjustment
regions
Operating modes
Normal
operation
Sitting
operation
Other
NFC tag location in device (note: this feature is not yet implemented)
Keypad lock
Battery usage
Silent operation
Firm operation
Acknowledge-
ment of infor-
mation signal
Bluetooth con-
nection estab-
lished (note:
this feature is
not yet imple-
mented)
Supine
operation

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2 Introduction
2.1 Intended purpose
Carital®OptimaCot is a mattress system for the prevention and treatment of pressure
ulcers.
2.2Operatingenvironmentanduserprole
The Carital®OptimaCot mattress system is intended for both home use and healthcare
environments (regular wards and intensive care).
The user can be a healthcare professional or a non-professional that has read the user’s
guide and understands the basic operating principle and use of the mattress system.
2.3 Target patients
The Carital®OptimaCot mattress system has been designed for child patients with very
high or high risk of getting a pressure ulcer. The mattress system is intended for patients
weighing 6-50 kg.
2.4 Contraindications
The Carital®OptimaCot mattress system must not be used with patients with lower ex-
tremities amputated from the midline of the legs upwards.
2.5 System description
The Carital®OptimaCot mattress system has a double cell structure where the tun-
nel-shapeduppercells,lightlylledwithair,adjusttothepatient’sbody.Theinner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 the patient.
The Carital®principle: Maximizes contact area,
minimizes contact pressure and tissue deformation.
2.6 Products whose use is described in this guide
• OptimaCot controller and cells
• Medicase®hygiene cover
• Comfort cover add-on
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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This guide applies only to second-generation Carital®controllers. A sec-
ond-generationcontrollercanbeidentiedwithitsserialnumberbeginning
withthePCidentier.
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 State or Sov-
ereign 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.
2.7 Warnings
• This guide applies only to second-generation Carital®controllers. A second-genera-
tioncontrollercanbeidentiedwithitsserialnumberbeginningwiththePCiden-
tier.
• 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 State 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congurationisincompleteoranyofitscomponentsis
broken, worn or contaminated. Worn, missing and broken parts must be replaced
and contaminated once cleaned.

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• 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 purpose 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
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
suocation.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 sides or folding parts of the bed.
• 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deate.
• 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.
• Before placing the patient on the mattress, start the device as described in section
5.1, and allow the mattress system to adjust to Normal operation successfully, so
that all green LEDs are lit in the centre of the LED light bar.
• Thedimensionsofthemattressshouldalwayst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.

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• If side rails are used with the Carital®mattress system, make sure that the height of
the side rails is at least 350mm from the bed base covering at least 50% of the length
of the mattress.
• Thesupportsurfaceshouldtthebedsothatitdoesnotextendovertheedgesof
the bed or that no gap is formed between the support surface and the edges of the
bed.
• With electrically adjustable beds, the suspension straps must be secured to the mov-
ingbackpartofthelyingsurface,nottothexedpartofthebedbody.
• Do not place a power cable in the conduit if you believe the power cable may be
clamped by the sides or folding parts of the bed.
• When using foam supports for the cover, make sure the patient is always lying on the
cells, not on the foam supports.
• Before evacuation, disconnect the controller’s power cable from the mains and the
air tubes from the controller.
• If Sitting operation is used for more than 60 minutes at a time, the patient is subject
to an elevated risk of pressure ulcers.
• When the cells are hardened, their pressure reduction capacity is reduced.
• Supineoperationisusedonlyforthetreatmentofimmobilepatientsonhorizontal
position, lying on their backs. Selecting Supine operation in other treatment posi-
tionswillincreasetheriskofpressureulcers.Makesurethepatientislyinghorizon-
tally on their back when selecting this function.
• The controller is only able to detect defective inner cells according to chapter 6.3.
Thedefectiveuppercellsmustbeidentiedbytheuseraccordingtotheinstructions
stated in chapter 7.2.3.
• Whenresuscitating,turnothedevicefromthestandbybuttonandstartCPRim-
mediatelywithoutdeatingthecells.DonotuseFirm operation when resuscitating.
• 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.

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• Ensure that the cover is entirely dry before commissioning it.
• Do not wash the foam supports.
• Ifthemattress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 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
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.
• 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 purpose.
• 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, 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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purposeorresultingfrommaintenance,repairormodica-