CARITAL Optima7080 User manual

KOHJ-H-01-EN1-1.7-15112021 1
User’s guide
Optima7080 / Optima8590

2
KOHJ-H-01-EN1-1.7-15112021
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 7
2.7 Warnings 7
3 Covers 11
3.1 Medicase®hygiene cover 11
3.2 Mediresc™rescue cover 11
3.3 Antistatic Medicase®hygiene cover 12
3.4 Rehab add-on for the cover 13
3.5 Comfort add-on for the Medicase®hygiene cover 13
 3.6Takingothecover 14
3.7 Putting on the cover 15
4 Commissioning 17
4.1 Components of the mattress system 17
4.2 Connecting the mattress system to the bed 19
4.3 Commissioning the controller 21
4.4 Lifting the controller 22
4.5. Things to check before use 23
5 Operation 24
5.1 Turning on the controller and activating Normal operation 24
 5.2Turningothecontroller 25
5.3 Sitting operation 25
5.4 Firm operation 26
5.5 Silent operation 27
5.6 Supine operation 28
5.7 Keypad lock 28
5.8 Operating the controller using battery power 29
5.9 Resuscitation situations 30
5.10 Fault situations 30

KOHJ-H-01-EN1-1.7-15112021 3
6 Information signals 30
6.1 Pressure sensor function error 31
6.2 Elevated pressure ulcer risk (sitting operation) 32
6.3 Check the air tubes (leak in tube or inner cells) 32
6.4 Pressure target value invalid 33
6.5 SD card operating error 34
6.6 Scheduled maintenance notices 34
6.7 Electromagnetic interference and display information fault situations 35
6.8 Battery operating error 36
6.9 Battery charge falls low 36
6.10 Device internal error 37
7 Maintenance and storage 39
7.1 Cleaning 39
7.1.1 Controller and tube system 39
7.1.2 Cells 39
7.1.3 Medicase®, Mediresc™and antistatic Medicase®cover 39
7.1.4 Comfort add-on for the cover 40
7.1.5 Rehab add-on for the cover 40
7.2 Checking the operability of the mattress system 40
7.2.1 Controller 40
7.2.2 Cover 41
7.2.3 Cells 41
7.2.4 Life cycle of the mattress system 42
7.3 Scheduled maintenance 42
7.3.1 Scheduled maintenance interval 42
7.3.2 Checking the maintenance data in the controller’s maintenance view 43
7.4 Storage and transport 43
8 Disposal 45
8.1 Controller 45
8.2 Cells and cover 45
8.3 Packaging 45
9 Warranty 45
10 Technical specications 46
11 Contact details of the manufacturer and service 48
Appendices 49

4
KOHJ-H-01-EN1-1.7-15112021
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

KOHJ-H-01-EN1-1.7-15112021 5
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

6
KOHJ-H-01-EN1-1.7-15112021
2 Introduction
2.1 Intended purpose
Carital®Optima is a mattress system for the prevention and treatment of pressure ulcers.
2.2Operatingenvironmentanduserprole
The Carital®Optima mattress system is intended for both home use and healthcare envi-
ronments (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®Optima mattress system has been designed for patients with very high or
high risk of getting a pressure ulcer. The mattress system is intended for patients weigh-
ing7–300kg(cellwidth≥80cm)or7–200kg(cellwidth70-75cm).
2.4 Contraindications
The Carital®Optima mattress system must not be used with patients with lower extrem-
ities amputated from the midline of the legs upwards.
2.5 System description
The Carital® Optima mattress system has two (2) dierent variants, which are deter-
mined by the width of the cells;
 •Optima7080(theidentierOP7atthebeginningoftheREFeldonthenameplate
of the controller): intended for cell widths of 70 cm to 80 cm
 •Optima8590(theidentierOP8atthebeginningoftheREFeldonthenameplate
of the controller): intended for cell widths of 85 cm to 90 cm
The Carital®Optima mattress system has a double cell structure where the tunnel-shaped
uppercells,lightlylledwithair,adjusttothepatient’sbody.Theinnercellsarein-
terconnected, 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.
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

KOHJ-H-01-EN1-1.7-15112021 7
2.6 Products whose use is described in this guide
• Optima7080/Optima8590 controller and cells
• Medicase®and Mediresc™covers and antistatic Medicase®hygiene cover
• Rehab and Comfort cover add-ons
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.

8
KOHJ-H-01-EN1-1.7-15112021
• 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.
• 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.
• Verify that the variant of the controller corresponds to the variant of the cells by
checkingtheREFeldonthecontrollerandthecellIDlabel.
• 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.

KOHJ-H-01-EN1-1.7-15112021 9
• 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.
• 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 Rehab add-on for the cover, make sure the patient is always lying on the
cells, not on the side supports.
• The side handles of the Mediresc™cover are intended only for general handling of the
mattress without patient load. Failure to observe this provision may result in broken
handles and lead to patient or care personnel injury.
• 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.

10
KOHJ-H-01-EN1-1.7-15112021
• 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 side supports made of foam plastic.
• 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 weighing over 200 kg,
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.

KOHJ-H-01-EN1-1.7-15112021 11
• 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-
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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 ser-
vice.
• Scheduled maintenance may only be carried out by Carital®service.
3 Covers
This section presents the cover types available for the Carital®Optima mattress system
aswellashowtotakeoandputonthecover.
3.1 Medicase®hygiene cover
The Medicase®hygiene cover protects the mattress system’s cells from liquids and body
uids. The surface of the cover is polyurethane and the lower layer is polyester. The
covercanberemovedusingzippersonthreesides.
There is a power cable conduit on the edge of the cover with power cable pre-installed.
The air tubes of the cells are routed out at the left corner of the cover at the foot end.
The integrated conduit prevents the power cable from being clamped by the sides of the
bed or run over by its wheels when moving the bed.
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.
3.2 Mediresc™rescue cover
ThexedMediresc™rescue cover is designed for rapid evacuation of the patient in case
ofre,forexample.Thetoplayer of the bluesurface fabric ispolyurethaneandthe
lower layer is polyester. The surface of the black bottom fabric is slippery polyester and
theinnerlayerispolyurethane.Thecovercanberemovedusingzippersonthreesides.

12
KOHJ-H-01-EN1-1.7-15112021
The Mediresc™rescuecoverhasintegratedstrapswithwhichthepatientcanbexedto
the mattress in case of evacuation.
Patient fastened to the Mediresc™rescue cover
The ends of the mattress have rescue/pulling lines which enable evacuation by one per-
son, physical conditions allowing.
Mediresc™rescue cover, lifting handles
The Mediresc™rescue cover has 2 lifting handles on both sides to facilitate the handling
of the mattress.
The air tubes of the cells are routed out at the left corner of the cover at the foot end.
In the Mediresc™rescue cover, the controller’s power cable is routed through a conduit
integratedtothebottomofthemattress,accessiblebyazipper,preventingclampingof
the power cable by the sides of the bed or under the bed’s wheels when moving the bed.
Before evacuation, disconnect the controller’s power cable from
the mains and the air tubes from the controller.
The side handles of the Mediresc™cover are intended only for gener-
al handling of the mattress without patient load. Failure to observe
this provision may result in broken handles and lead to patient or
care personnel injury.
Do not place a power cable in the conduit if you believe the power
cable may be clamped by the sides of the bed.

KOHJ-H-01-EN1-1.7-15112021 13
3.3 Antistatic Medicase®hygiene cover
The antistatic Medicase®hygiene cover protects the mattress’ cells from liquid ingress
andpreventsthebuild-upofstaticcharge(surfaceresistance≤105Ω).Theantistatic
coverisintendedspecicallyforenvironmentswherethebuild-upofstaticchargemay
pose a safety risk.
The surface of the cover is polyurethane and the lower layer is polyamide/elastane. The
covercanberemovedusingzippersonthreesides.
There is a power cable conduit on the edge of the cover with power cable pre-installed.
The air tubes of the cells are routed out at the left corner of the cover at the foot end.
The integrated conduit prevents the power cable from being clamped by the sides of the
bed or run over by its wheels when moving the bed.
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.
3.4 Rehab add-on for the cover
All covers are available with integrated Rehab side bars. The side support bars improve
the support of the support surface’s edge, promoting the patient’s independent getting
up from the bed and sitting down on it.
• There are dedicated hygiene covers for the side bars.
 •Sidebarsareavailableinone-sideandtwo-sidecongurations.Intheone-sidecon-
guration,thesideofthebarcanbechangedasnecessary.
• Make sure that the side support bar is correctly positioned in such a way that its
wedge at the foot end has the sloped part up.
Wedged side support bar of the Rehab add-on.
When using Rehab add-on for the cover, make sure the patient is
always lying on the cells, not on the side supports.
3.5 Comfort add-on for the Medicase®hygiene cover
The Comfort cover is the Medicase®hygiene cover plus a detachable cotton top. The top
canbedetachedbyundoingtwozippers.
The Comfort option is not available for the Mediresc™rescue cover or the antistatic Medi-
case®hygiene cover.

14
KOHJ-H-01-EN1-1.7-15112021
1. Remove the mattress from the controller
by disconnecting the air tube system and
power cable. Disconnect the power cable
from the electrical outlet.
3. Open the zipper fully to expose the air
tube system and power cable.
5. Open the mattress zipper from the end
until the air tube connectors are visible.
2. Start by pulling down the zipper on the
tube sleeve.
4. Pass the power cable and plug out of the
tube sleeve.
6. If necessary, disconnect the air tubing
from the cell’s tube system. Pass the air
tubing through its hole.
3.6Takingothecover

KOHJ-H-01-EN1-1.7-15112021 15
3.7 Putting on the cover
1. Place the cell over the cover. Ensure that
the label in the foot section indicating
the direction to put on the cover is faced
correctly.
3. Check that the necessary accessories are
readily available: power cable, air tubes,
suspension straps (2) and side support
bars (only covers with the Rehab add-on).
2. If you notice any protruding inner cells,
evenly pull them inside the upper cells.
4. To secure the strap, pass it through the
rst cell fastener adapter.
7. Open the mattress zipper fully. 8. Pass the cell’s suspension straps out from
their holes.

16
KOHJ-H-01-EN1-1.7-15112021
5. Pass the strap through the lock, adjust
the strap to be uniform in length and
close the lock.
7. Close the cover zipper and pass the cell
air tubes out of their hole. Note: If the
cover includes the Rehab add-on, place
the side support bars as instructed in
section 3.4.
9. Close the zipper on the tube sleeve.
6. Pass the strap through the hole in the cov-
er. Repeat for the other strap.
8. Pass the power cable plug from the hole
in the tube sleeve. Attach the air tubing
to the cell’s air tube system.

KOHJ-H-01-EN1-1.7-15112021 17
4. Commissioning
4.1 Components of the mattress system
Controller
Controller Type plate stickers on the side and at the bot-
tom of the controller contain the device iden-
tication information.
The lockable power cable (5 m). The power cable is delivered
pre-installed in its designated conduit in the cover.

18
KOHJ-H-01-EN1-1.7-15112021
Cells
Cover
The cover is delivered pre-installed on the cells. The cover is equipped with a label
thatindicatesthesize,type,timeofmanufacture,manufacturerdata,andwashingand
cleaning instructions for the cover.
Other
The controller has an integrated two-sided quick guide that describes the functions of
the device and provides an example of troubleshooting.
The double-sided quick guide is found on the back of the controller
and is released for viewing by raising it upwards.
Be sure to put the quick guide caddy back in place after examina-
tion.
The delivery also includes this long-form user’s guide.
Cells without cover. The cells are delivered
with the cover on. The size and serial number
of the cells are marked on the bottom mat of
the cells close to the air tube outlet.
Air tube system between the controller and
cells, including connectors

KOHJ-H-01-EN1-1.7-15112021 19
If the delivery set is damaged or incomplete, do not commission the
device. Immediately contact the mattress system’s reseller.
The temperature of the controller may have decreased or increased
during transport beyond the limits of the allowable operating tem-
peratures. 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 recom-
mended operating temperature of +10°C – +35°C.
4.2 Connecting the mattress system to the bed
The Optima mattress system is intended for use in place of a regular support surface.
The mattress system can be installed in all standard beds but the base of the bed must
beasataspossible.Ifthebaseisunevenortherearelargegapsinthelyingsurface,an
extra bottom support foam (optional accessory) can be used inside the cover underneath
the cells.
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.
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 mattress system can also be used with electrically controlled beds with adjustable
back and leg parts. Any sliding of the mattress may be prevented by attaching the cells
to the bed using suspension straps through the cover. The suspension straps must be at-
tached to the mobile, rising/lowering back part of the bed’s lying surface.
Attaching the straps
2. Pull the strap through the lock, tighten
securely and press the lock toward the
strap to lock.
1. Pass the strap ends through the holes on
the back part of the bed.

20
KOHJ-H-01-EN1-1.7-15112021
Undoing the straps
1. Lift the lock up. 2. Pull the strap through the lock.
With electrically adjustable beds, the suspension straps must be se-
cured to the moving back part of the lying surface, not to the xed
part of the bed body.
Do not use extra bed sheets, pillows or heavy positioning pillows on
the mattress.
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.
3. Repeat on the other side.