Care of Sweden CuroCell AUTO4 User manual

Instructions for use
2020-12-08
CuroCell®AUTO4
CuroCell®AUTO4 CX13
Automatic active air mattress systems
Instructions for use item number: 95-001616

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Table of contents
WARNINGS AND SAFETY PRECAUTIONS 3
1. Introduction 5
2. Product description 6
3. Assembly/Installation 9
4. Operation 10
5. Reuse, cleaning and reconditioning 13
6. Storage 15
7. Maintenance 15
8. Troubleshooting 16
9. Technical description 17
10. Spare parts 19
11. Options and accessories 19
12. Warranty 21
13. Other information 21
14. Notes 22

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WARNINGS AND SAFETY PRECAUTIONS
Read all instructions before use or repair
WARNING! To minimize the risk of fire, personal injury and equipment/property damage adhere to
the following instructions:
1. The product must only be installed and used for its intended purpose according to the
instructions in this manual and/ or other documentation from Care of Sweden. The
product must not be combined, assembled or repaired with parts (e.g. control unit and
mattress), accessories or spare parts other than those described in this manual or other
documentation from Care of Sweden. The product must not be modified in any way.
2. The product must be placed and used so that it does not become trapped or
damaged. Note: Be particularly aware of trapping damage when using side rails.
Always make sure that the mattress is the correct size for the bed.
3. Regularly check product functionality by performing a hand check (see section 4.4).
4. When the product is used for individuals needing special supervision, such as children,
continuous monitoring is required.
5. The mattress is protected by a hygiene cover; avoid using multiple hygiene covers as this
can affect the vapor permeability of the mattress.
6. The hygiene cover does not allow liquid or air to penetrate, but is vapour
permeable. Make sure that the user is positioned correctly to avoid the risk of
suffocation.
7. Be careful with sharp objects to prevent damage to the hygiene cover.
8. Do not open the control unit housing – risk for electric shock. Servicing and
maintenance must be performed by Care of Sweden or one of its authorized
service technicians.
9. Route the power cable to the control unit carefully to avoid tripping. Also make sure
that the user is lying correctly on the mattress according to the instructions and use a
cable holder if possible.
10. To avoid the risk of strangulation, make sure that the cable and tubes are routed to prevent
someone getting caught up in them.

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Note: The responsible healthcare provider must inform the user/operator of the following:
11. Do not use the product in bathrooms or other area where there is a risk of the
control unit coming into contact with water or other liquids. Except for specified
cleaning, never handle a product that has come into contact with water/liquid. Pull
the plug out of the electrical socket immediately and send the product to an
authorized service technician for servicing
12. Do not use close to or in contact with fire sources/hot surfaces, such as fire, burning
cigarettes, hot lamps, heating fans or heating stoves/open fires as this could damage the
product.
13. Do not store or use the product in direct sunlight. The product may be damaged by the
elevated temperature and UV light.
14. Strong magnetic fields or wireless communication equipment (e.g. wireless home
network products, mobile phones, walkie-talkies, cordless phones and their base
stations, radio transmitters, etc.) may affect the product’s functionality and should be
kept at a distance of at least 1 meter from the control unit.
15. Never use the product if the power cable, plug of the control unit or power supply
housing is defective, if the control unit housing is damaged, or if it is not functioning
properly. Contact an authorized service technician for examination and repair.
16. Never connect anything other than the Care of Sweden supplied power supply to the
control unit power cable connector.
17. If the hygiene cover is equipped with side handles, these are intended for managing
or relocating the mattress. Do not use the handles to lift the mattress with an user
lying on it. All other use takes place under your own liability and is not covered by the
product warranty.
18. To prevent the Power supply from being pulled out, exercise caution when there are
children and pets in the environment around the equipment.
19. Use of this product adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this product and
the other equipment should be observed to verify that they are operating normally.
20. In order to minimize the risk of wounds occurring on the feet, make sure that the user
doesn’t come into contact with the hangers of the control unit.

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1. Introduction
CuroCell® air mattresses work according to the alternating pressure principle, a technique that
is thoroughly tried and tested and has been used for a long time. Alternating pressure means
that the pressure is alternated regularly between the cells in order to simulate the body’s own
movements. Periods are created in which the pressure is lower or completely absent. This
provides good conditions for the skin to recover and to prevent injury.
Always read the instructions for use prior to use.
For further questions regarding installation, use or maintenance please contact Care of
Sweden or your local distributor.
1.1 General information
This system is a medical device with CE marking in accordance with Medical Device Regulation
MDR (2017/745).
The system has been fully or partially designed and verified in accordance with the standards
listed in section 9.2. Standards.
According to statutory regulations made by the authorities regarding medical devices, the
manufacturer is required to report all accidents or incidents involving the products. We would
be very grateful for all information involving accidents or incidents relating to our products, by
reporting them immediately to us, at Care of Sweden.
1.2 Intended use
The system consists of a pump and a mattress and are used for prevention and as an aid in the
treatment of pressure ulcers/pressure injuries (PU/PI).
1.3 Indications
For users with pressure ulcers/pressure injuries (PU/PI) up to and including category 4 and
unclassified PU/PI (unstageable and suspected deep tissue injury¹). As well as for users in risk
of PU/PI.
1.4 Contraindications
There are no known contraindications.
1.5 User application
The systems can be used in all kinds of health care environments. It is available in two
versions. CuroCell®AUTO4 CX13 is an overlay mattress and is placed on an underlying
mattress. CuroCell®AUTO4 is a replacement mattress placed directly on the bed base. The
mattress is intended to be used for people with a recommended minimum height of 120 cm
and a recommended user weight of up to 180 kg.

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(1) European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury
Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline.
Emily Haesler (Ed). EPUAP/NPIAP/PPPIA: 2019
1.6 Other information
Action plan for pressure ulcers/pressure injuries
For the best possible results when using this product, we recommend a structured and
planned approach. Examples that can be applied to the use of our products can be found in
the “Action plan for pressure ulcers/pressure injuries” guidelines.
The Mattress Guide
This guide provides guidance to personnel and prescribers when choosing a mattress from
Care of Sweden. CuroCell® AUTO4/AUTO4 CX13 is a mattress in function group C. This
information can be obtained from our website, www.careofsweden.com, or ordered from
Customer Service (see contact information on the last page).
2. Product description
2.1 Mattress
1. Mattress
2. CPR (Rapid deflation)
3. Pump connector
4. Pump
NOTE:
•For certain users, such as amputees, the recommended height measurement may not
be met. Users in these groups may, however, require other settings, as the entire
surface is not under load. To check functionality, see sections 4.2, 4.3 and 4.4.
•When used together with positioning pillows, read the pillow instructions for use
carefully for correct positioning of the user.
•Whenever this product is used with an evacuation sheet, it is the responsibility of the
attending personnel to ensure that evacuation can be performed safely.
•Be careful when using bed rails or other protection on the bed so that the mattress is
not pinched or damaged.
•The mattress must not be lifted with a person lying on it or used for any other type of
transport other than necessary evacuation using an evacuation sheet.
•The mattress is not suitable for use during X-ray examinations. This is because of the
risk of image blurring and artefacts that may lead to diagnostic errors.
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C
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1
2
3
4
5
6
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3 static head cells.
If the product is equipped with ventilated cells, they are found here (9 cells).
Mattress (without cover)
2.2 Pump
1. Tube connector 3. Fuses (two) 6. Hooks
2. Control panel 4. Off/On (0/1) 7. Air filter
5. Power cable connector
2.3 Pump functions – control panel
1. Automatic settings
This pump is equipped with a function that automatically sets the pressure based on the user’s
weight, posture and position. There are three ways to use this function.
1. The system adjusts the settings automatically when the system has been started.
2. Press the button and the system readjusts the automatic settings.
3. The system itself will start this function if any significant changes occur during use.
Status lights
1. All three lights lit – Automatic settings adjustment under way.
2. Only the light under the checkmark (left) is lit – The mattress is ready to use, normal mode.
C
P
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1
3
2
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3. The light on the right is lit – The pump will automatically adjust its settings within five
minutes.
Once the settings have been automatically adjusted, the system will revert to the previously
used programme. However, when started it will switch to Alternating mode by default.
To stop the automatic setting adjustments, press the button.
2. Comfort setting
The pressure can be increased or decreased one level depending on the user’s comfort
requirements. This function cannot be used when the Sit function programme is activated.
3. Programmes
Four programmes are available. Repeatedly pressing the button switches between the
different programmes.
1. Alternating mode. Here, the pressure alternates between the cells.
2. CLP mode. Here, the pressure will be same in all cells. This is also called “Constant low
pressure”.
3. Sit function. Gives the user more support in a sitting position. This function can be used in
both Alternating and CLP mode.
4. Maximun pressure (caring mode)
With this function, the entire mattress is inflated and provides firm support. This function
automatically reverts to the previous setting after about 24 minutes. NOTE: The automatic
settings are overridden when using this programme.
5. Panel lock
Press the Panel lock button to lock or unlock the panel. The green light is lit when the panel is
locked. The panel locks automatically after five minutes of inactivity. This is to prevent the
settings being changed inadvertently.
6. Power off/on
Turns the power to the control panel on or off. NOTE: Check that the power cable is properly
connected and that the power switch on the side of the pump is in position 1 (on).
7. Notification
In the event of problems with notification, see section 8 for troubleshooting.
A. Power supply notification
If the pump loses power an audible and visual notification is triggered. Turn off the notification
by pressing the “Notification off" button.
B. Low pressure notification
If the mattress pressure is too low an audible and visual notification is triggered. Turn off the
notification by pressing the “Notification off” button. It is reactivated after about five minutes
if the pressure has not returned to normal.
Alternating
CLP
Alternating + Sit function
CLP + Sit function

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3. Assembly/Installation
When unpacking, check that no parts are damaged. If any damage is found, contact Care of
Sweden or your local distributor before using the product.
1. If the mattress has an integrated foam cushion (CuroCell®
AUTO4) then the mattress is placed directly on the bed
base. Secure the mattress to the moving parts of the bed
using the straps on the cover.
In the case of CuroCell® AUTO4 CX13, place the mattress on
the existing mattress and secure the elastic straps around
the underlying mattress.
Note:
• Make the bed with a sheet to improve user comfort.
• Check that the CPR valve is closed.
• If an adjustable bed is used, the mattress should be
secured only to the moving parts of the bed.
• Check the cells and press studs to ensure they are
correctly assembled.
2. Hang the pump on the foot end of the bed or place the
pump on a firm, level surface.
Place the power cable so there is no risk of tripping over it,
running over it with the bed wheels or pinching it when
raising or lowering the bed.
If a cable holder is used (optional): open the press studs,
insert the power cable and close the press studs.
Note! In order to minimize the risk of wounds occurring on
the feet, make sure that the user doesn’t come into contact
with the hangers of the pump.
3. Connect the air tubes from the mattress to the side of the
pump. A click is heard or felt when they are correctly
connected.
4. Check that the power switch on the side is set to 0 (off).
Plug the power cable into an approved socket (220 V).
For 80/85/90x200/210
For 105/120x200/210

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4. Operation
Note: Always read the instructions for use prior to use.
4.1 Start
1. Set the power switch on the side of the pump to 1 (on).
2. The mattress will start to inflate. It takes at least 15 minutes to fully inflate the mattress.
3. If necessary, the user may lie down on the
mattress immediately without it being inflated.
The underlying mattress bears the weight during
the inflation phase. If the underlying mattress is
an air-filled type, it must be fully inflated. When
the top-left light is lit (only the light under the checkmark) the system is fully inflated.
NOTE: Each time the systems starts up, it always begins by fully inflating the mattress and
automatically adjusting the settings. See section 2.3 for more information. After automatically
adjusting the settings, the system switches to Alternating mode by default.
4.2 Programme selection
Four different programmes are available. See section 2.3 for detailed information. We
recommend Alternating mode as the default setting.
4.3 Comfort setting, fine-tuning
The air pressure in the mattress can be adjusted up to three levels.
NOTE: When only parts of the mattress are under load, such as in the case of amputees, it may
be necessary to raise the setting using the comfort setting.
4.4 Hand check (function control)
A hand check is used to ensure that the mattress is
properly inflated. This should be done regularly,
such as once per shift, as well as after changing
position in the bed or changing the comfort setting.
Place a hand between the cells under the user’s
pelvic region. Check that the user doesn’t “bottom
out” and rest on the base. We recommend a
margin of one or two fingers.
If the margin is too small, one of the following two
alternatives can be used.
Initiate automatic settings adjustment or raise the
comfort setting to the next level. Wait ten minutes
and perform a new hand check.

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4.5 CPR
In case of an emergency where CPR (cardiopulmonary
resuscitation) is necessary: Quickly pull the CPR strap then
loosen the quick connectors on the side of the pump for the
fastest possible deflation.
NOTE:
Make sure that the CPR strap is properly secured after use.
4.6 Notifications
In the event of unusually low air pressure in the mattress, the light for the low pressure
notification lights and a buzzer sounds. See section 8 for troubleshooting.
Deactivate the notification by pressing the “Notification off” button on the pump control
panel. If the problem is not resolved within about five minutes the notification will be
reactivated.
The pump is also equipped with a power supply notification. If the pump loses power an
audible and visual notification is triggered. Turn off the notification by pressing the
“Notification off” button.
4.7 Transport function
If the user needs to be moved in the bed the tubes can be
connected together (detached from the pump). The mattress
is put in constant low pressure and is in so-called transport
mode.
We recommend using this function for short periods only.
WARNING!
If the air pressure remains low, search for damage to the mattress and the tubes. Repair if
necessary or contact Care of Sweden or your local distributor.

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4.8 Heel function
The following alternatives can be used to relieve sensitive heels.
CuroCell AUTO4 is a combination of foam and air. The foam core has a tapered design to
further reduce pressure.
CuroCell AUTO4 CX13 is available with the following options:
Heel function with valve (option)
This function enables pressure relief for the user’s heels.
This is achieved by disconnecting (shutting down) the
cell in the mattress directly under the user’s heel(s). It
will no longer be inflated and will create a space
between the cells, providing relief to the user’s heel(s).
This function is activated by pressing the button (1) and
separating the connector, leaving the cell in place in the
mattress. The cell is reactivated by reattaching the
connector.
Heel function with lower heel cells (option)
This alternative is an option with lower heel cells at the foot end.
1

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5. Reuse, cleaning and reconditioning
The product is reusable. When reusing, it is important to follow the instructions below for
cleaning and reconditioning. Before using the product again for a new user, it is
recommended to clean the mattress in accordance with the instructions below. Consult
your hygiene manager or Care of Sweden for help and instructions if you are unsure.
Cleaning and reconditioning should otherwise be performed as required.
5.1 Cleaning
PUMP
Wipe off the pump with a damp cloth and mild cleaning solution for this purpose:
such as alcohol with or without tenside surfactants, oxidizing solutions, chlorine
max 1 % or hydrogen peroxide max 1,5 %.
If using a different agent, choose one that does not affect the pump.
MATTRESS COVER
Covers can be wiped off with a mild cleaning solu- tion for this purpose such as:
alcohol with or with- out tenside surfactants, Isopropanol 70 %, oxidizing solutions,
chlorine max 1 % (max 10% for cover Stone) or hydrogen peroxide max 1,5 %.
Excrement and blood stains must be removed as soon as possible using cold water. Carefully
follow local instructions and the instructions for the detergent.
Multi-layer covers should be divided before washing. The parts should be washed with
similar colours.
Chlorine and phenol-based cleaners could adversely affect the PU surface and
should be avoided. If chlorine is used, we recommend a mixture of max 1 % (max
10% for cover Stone).
INNER COVER
Clean the affected area with a mild cleaning solution for this purpose such as: alcohol with or
without tenside surfactants, Isopropanol 70 %, oxidizing solutions, chlorine max 1 % or
hydrogen peroxide max 1,5 %.

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5.2 Reconditioning
PUMP
See section 5.1 for instructions.
MATTRESS
1. Disconnect the tube connector from the pump and remove the air from the
mattress.
2. Remove the covers. For more information of cleaning the covers, see section 5.1.
3. Move the mattress to a clean area that is suitable for cleaning.
4. Wipe off the cells, all tubes and the CPR module with a mild cleaning solution for this
purpose such as: alcohol with or without tenside surfactants, Isopropanol 70 %, oxidizing
solutions, chlorine max 1 % or hydrogen peroxide max 1,5 %. Let it dry.
5. Wipe off the work surfaces using a suitable detergent and/ or disinfectant.
6. Put the mattress together. If cells for any reason have become loose from the tubes,
these must be replaced according to the drawing in section 2.1.
FOAM CORE
Clean the affected area with a mild detergent (such as washing-up liquid) and water or with an
alcohol-based disinfectant /cleaner intended for this purpose.
Gently squeeze out any water.
6. Storage
NOTE:
Check the hygiene cover, cells and hoses each time the product is
cleaned. If damaged, it must be replaced or repaired. Also check the pump, tube connectors
and power cable during cleaning. Damaged parts must be replaced or repaired.
Do not wring or roll the foam core to extract the water. Let it dry in a warm, ventilated area
(not in direct sunlight). The foam core must be completely dry before it is used again.

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6. Storage
It is advisable to store the mattress and pump in the product bag (accessory). Handle the
stored product with care. Do not place any heavy objects on top of it.
7. Maintenance
7.1 General
1. Check the power cable and plug for damage and scratches.
2. Check the mattress protection to make sure it is undamaged and that covers and cells are
correctly assembled.
3. Check that the air flow alternates between the different outputs on the side of the pump.
4. Check that no tubes or connectors are damaged or pinched. Contact Care of Sweden or your
local distributor if any spare parts are required.
7.2 Changing fuses
1. Remove the plug from the wall socket when replacing
fuses.
2. Use a screwdriver to remove the fuse cover. Pull out
the fuse holder.
3. Insert a new fuse of the same type (T1A/250V) and
screw the protective cover back into place. There are
two fuses.
7.3 Changing the air filter
1. Loosen the small, round protective plate on the back of
the pump.
2. Remove the filter from the holder.
3. Insert the new filter in the holder and replace
the protective plate.
If the pump is used in a very dirty environment, the filter
should be checked regularly.

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8. Troubleshooting
Pump does not start Check that the power cable is connected to a socket.
Check the fuses.
Notification triggered Check that the quick connectors for the tubes on the side
= mattress losing air of the pump are properly connected.
Check that the CPR valve is closed.
Open the mattress and check for any leaks from air cells or
tubes. Check that all tube connectors are fine and properly
connected.
No air in head cells When inflating the mattress the three static head cells are
inflated last.
User bottoms out Check the mattress in accordance with “Notification
triggered” above. See sections 4.3 and 4.4 for more.
Mattress not stationary Check that the mattress is secured with the elasticated
straps to the underlying mattress or, if the mattress has an
integrated foam cushion, secured with the straps to the
bed base.
Some cells less inflated This is normal as the air supply alternates between cells
every cycle (one cycle = ten minutes).
Noisy pump, vibrations can be Check that the pump is correctly attached to the bed.
felt Resonance may occur in parts of the bed. Remove the
pump and listen to see whether there’s any difference. Can
be resolved by placing the pump on a level surface or
putting, for instance, a towel between the pump and the
bed.
If your questions are not answered by the above information, please contact Care of Sweden
or your local distributor.
Problem Solution

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9. Technical description
9.1 Technical specification
PUMP
SPECIFICATION
Model
CuroCell® AUTO4
Voltage
220 V-240 V, 50-60 Hz
Current
0.07 A
Fuse type
T1A/250V
Cycle
10 min
Dimensions (LxWxH)
29.1 x 20 x 11.7 cm
Weight
2.2 kg
Ambient environment
Temperature
Operation: 10°C ˜ 40°C
Storage: -15°C ˜50°C
Shipping: -15°C ˜70°C
Humidity
Operation: 10%
˜
90% non-condensing
Storage: 10% ˜90% non-condensing
Atmospheric pressure
700 hPa-1060 hPa
Classification
Class II, Type BF, IP41
MATTRESS
SPECIFICATION
Model
CuroCell® AUTO4, AUTO4 CX13
Dimensions (WxLxH)
80/85/90/105/120x200/210x19 cm
Weight
CuroCell® AUTO4, 13 kg (90x200 cm)
NB: Care of Sweden reserves the right to modify the product specification at any time.
9.2 Standards
The system is tested and approved according to the following European standards where
applicable requirements are met.
IEC 60601-1 EN ISO 10993 ISO 3746
IEC 60601-1-2 EN 12182 ISO 11201
IEC 60601-1-11 EN597-1
IEC 60601-1-6 EN 597-2
IEC 62304 EN ISO 14971
EN 14126
9.3 Labelling
Labels on the mattress include product name, item number, date of manufacture, size, EAN
number and care and washing instructions. The mattress also has labels for the top and
bottom and head and foot, as well as space for your own marking (such as ward number and
name).
WARNING!
Follow the operation and maintenance instructions carefully in order to prevent physical
injury, as well as damage to the product or other equipment.

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9.4 Symbol key
Type BF
Class II equipment (Double-
insulated)
The mattress should be
used with the user lying in
the lengthwise direction
Temperature range
Drip dry
Do not tumble dry
Do not dry clean
Chlorine
Recycling
Read the instructions for use
Machine wash at 70°C
CE-marked in accordance
with
Medical Device
Regulation MDR (2017/745)
Machine wash at 95°C
Placed directly on the
bed base
Tumble dry
Do not iron
Recommended user weight
User information – category
Wipe clean
Year-Month-Day
Counteracts shearing
Item number
XXXX-XX-XX
Function group
Do not machine wash
Manufacturer
Do not dispose of with
household waste; follow
recycling instructions
Foot placement
IP code (ingress protection
Heel function
UDI
Medical Device
Distributed by

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10. Spare parts
Top part Olivia, AUTO4 Bottom part CuroCell, AUTO4 Cover Olivia, AUTO4 CX13
Item no. Size Item no. Size Item no. Size
CC-906010 80x200 cm CC-905610 80x200 cm 292-080200 80x200 cm
CC-906011 80x210 cm CC-905611 80x210 cm 292-080210 80x210 cm
CC-906012 85x200 cm CC-905612 85x200 cm 292-085200 85x200 cm
CC-906013 85x210 cm CC-905613 85x210 cm 292-085210 85x210 cm
CC-906014 90x200 cm CC-905614 90x200 cm 292-090200 90x200 cm
CC-906015 90x210 cm CC-905615 90x210 cm 292-090210 90x210 cm
CC-906016 105x200 cm CC-905616 105x200 cm 292-105200 105x200 cm
CC-906018 120x200 cm CC-905618 120x200 cm 292-120200 120x200 cm
Item no. Description Size
CC-901001-K Air cell, PU 80x13 cm
CC-901002-K Air cell, PU 85x13 cm
CC-901003-K Air cell, PU 90x13 cm
CC-901004-K Air cell, PU 105x13 cm
CC-901005-K Air cell, PU 120x13 cm
CC-8217 Fuse (2-pack) -
CC-400903 Pump for mattress width 80, 85, 90 cm
CC-400904 Pump for mattress width 105, 120 cm
If other spare parts are required, please contact Care of Sweden or your local distributor
11. Options and accessories
11.1 Options
Comfort fabric
For users who are very sensitive to alternating pressure a comfort fabric can be used, which
further improves the comfort offered by the mattress.
Heel function
The following two alternatives are available to relieve sensitive heels. Deflation of cells with
check valves or lower cells.
Sturdy transport bag
Transport and storage bag.
Sheet holder
An aid for AUTO4 to help keep the sheet in place. A clip for attaching to the cover; six per
mattress.
Covers
With welded seams.

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11.2 Accessories
Comfort fabric CuroCell
Item no. Size
CC-907210 80x200 cm
CC-907211 80x210 cm
CC-907212 85x200 cm
CC-907213 85x210 cm
CC-907214 90x200 cm
CC-907215 90x210 cm
CC-907216 105x200 cm
CC-907218 120x200 cm
Sturdy transport bag
Item no. Size
58-900909 80-90 cm
58-900905 105-120cm
CC-9093 80-90 cm (AUTO4 CX13)
CC-9094 105-120 cm (AUTO4 CX13)
Sheet holder, each (Only AUTO4)
Item no.
CC-9075
Item no. Description
CC-900220 Heel function with valve (4 cells)
CC-900222 Heel function with valve (3 cells)
11.3 Other accessories
To ensure the best level of comfort, we recommend the use of accessories from Care of
Sweden since our products are designed to work well together. If you require any accessories,
or for more information about our products, please contact Care of Sweden or your local
distributor. You can also visit our website – www.careofsweden.com.