Care of Sweden CuroCell S.A.M. PRO User manual

EN
Instructions for use
2022-06-23
CuroCell S.A.M.® PRO
Constant low pressure reactive air mattress system
Instructions for use item number: 95-001410-EN0000

Table of contents
WARNINGS- AND SAFETY PRECAUTIONS 3
1Introduction.................................. 4
1.1 General information ........................ 4
1.2 Intended purpose ............................. 4
1.3 Intended user ................................... 4
1.4 Intended user environment .............. 4
1.5 Indications ....................................... 4
1.6 Contraindication .............................. 4
1.7 Clinical benefit ................................. 4
2Assembly and installation ............. 5
3Operation ..................................... 6
3.1 Operation (how to get started) ........ 6
3.2 Comfort settings .............................. 6
3.3 Hand check (function control) .......... 6
3.4 Cardiopulmonary rescitation (CPR) .. 7
3.5 Low pressure.................................... 7
3.6 Transport function ........................... 7
4Product description....................... 8
4.1 Pump................................................ 8
4.2 Control panel ................................... 9
4.3 Mattress ........................................ 10
5Reuse and cleaning ......................10
5.1 Cleaning pump ............................... 10
5.2 Mattress cover ............................... 10
5.3 Inner cover..................................... 11
6Storage ........................................12
7Maintenance................................12
7.1 Air filter and fuse replacement ...... 12
8Troubleshooting...........................13
9Technical specification .................14
9.1 Standards....................................... 14
9.2 Marking ......................................... 14
9.3 Symbol Key..................................... 15
10 Other information ................. 17
10.1Recommended lifetime of the product 17
10.2 Disassembly and recycling ........ 17
10.3 Returns ..................................... 17

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 used for its intended purpose as described in this manual.
The product may not be combined, assembled or repaired with other parts,
accessories or spare parts other than those described in this manual or other
documentation from Care of Sweden.
2. Do not use the pump in wet rooms where there is a risk of the pump coming into
contact with water or another liquid. Never handle a pump that has come into contact
with water/liquid. Pull the plug out of the electrical socket immediately and send the
product to an authorised service technician for servicing.
3. Do not use in the vicinity of or in contact with fire sources/hot surfaces, such as fire,
burning cigarettes or hot lamps. Although the product has undergone fire testing, it
could become damaged if it comes into contact with fire sources.
4. Position and use the product in a manner that prevents it from becoming trapped or
damaged. Be particularly aware of trapping damage the risk of crush injuries when
using bed rails.
5. Never use the product if the pump power cable, plug of the pump or power supply
housing is defective, the pump casing is damaged or it is not functioning properly.
Contact an authorised service technician for examination and repair.
6. Regularly check product functionality through a “hand check” (see section 3.4). Also
check that the comfort setting is correct as indicated in the table on the pump.
7. Continual monitoring is required when the product is used for individuals needing
special supervision, such as children.
8. The mattress is protected by a hygiene cover; avoid using multiple hygiene covers as
this can affect the vapor permeability of the mattress.
9. The hygiene cover does not allow liquid or air to penetrate but is vapour permeable
(vapour is wicked away). Make sure that the user is positioned correctly to avoid the
risk of suffocation.
10. Prevent damage to the hygiene cover from sharp objects.
11. If the cover is equipped with handles on the long sides, these handles are only to be
used for lifting and moving the mattress itself. All other use is not covered by the
product warranty.
12. The pump’s power cable should be positioned to minimise the risk of tripping or other
injuries; use a cable holder if possible.
13. There is a risk of strangulation if the power cable accidentally ends up around the
user’s neck; if possible, use a cable holder and make sure that the user is lying
correctly on the bed according to the instructions
14. The mattress is unsuitable for X-ray examinations because of the risk of blurred
images or artefacts that may lead to diagnostic error.

1Introduction
Always read the instructions for use prior to use.
1.1 General information
The product is a medical device with CE marking in accordance with MDR (EU) 2017/745.
According to this regulation the manufacturer is required to report all accidents or incidents
involving the products. All information involving accidents or incidents relating to our
products, shall be reported immediately to Care of Sweden.
1.2 Intended purpose
The mattress is intended to be used for prevention and as an aid in the treatment of pressure
ulcers/pressure injuries (PU/PI).”
1.3 Intended user
The mattresses are intended to be used by all kind of users, including lay persons.
1.4 Intended user environment
The mattresses are intended to be used in all kinds of healthcare environments, including
home care.
1.5 Indications
Suitable for a wide range of persons with increased risk for pressure ulcers/injuries, including
those with superficial ulcers, up to and included category 3 (in association with an
individualised plan of care). The mattress system is available in three versions. CuroCell
S.A.M.® PRO and CuroCell S.A.M.® PRO CF10 are top mattresses and are placed on an
underlying mattress. CuroCell S.A.M.® PRO CF16 is a replacement mattress placed directly on
the bed base. The recommended user weight is up to 250 kg
1.6 Contraindication
It is necessary for the prescriber of the mattress to make an individual assessment of the user
and decide whether the characteristics of the mattress is beneficial for the user based on
diagnosis.
1.7 Clinical benefit
Care of Sweden’s clinical benefits and claims for CuroCell® CLP reactive air mattresses systems
consist of:
•Safety
•Comfort
•Pressure redistribution
•Easy to handle
Note!
• When used together with positioning pillows, read the pillow instructions for use carefully for
correct positioning of the user.
• If you are using this product with an evacuation sheet, it is the user’s responsibility to ensure
that it is safe to use for evacuation.
• Remember that the underlying mattress is important for the product’s functionality.
• Do not store or use the product in direct sunlight. The product may be damaged by the
elevated temperature and UV light.

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2Assembly and 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.
1a. If the mattress is an overlay mattress, place the mattress on top of an existing mattress. If
possible, secure it by pulling the elastic bands on the bottom over the corners of the
underlying mattress.
or
1b. If the mattress is a replacement mattress and have an integrated foam core (CuroCell
S.A.M.® PRO CF16), place the mattress directly on to the bed base. Use the straps on the cover
to fasten the mattress to the bed base.
2. Hang the pump by the foot end of the bed or place it on a flat, sturdy surface. Place the
power cable so there is no risk of stumbling over it, run it over with the bed wheels or getting
it jammed when raising or lowering the bed.
3. Connect the air tubes coming from the mattress to the side of the pump. The pump and
hoses are equipped with quick connectors; an audible “click” will be heard when these have
been connected correctly.
4. Check to make sure that the power is set to “0” (off). Plug the power cable into an approved
outlet (110 or 220 V depending on the country and the voltage level) that is easily accessible.
Note!
• Check that the CPR valve is closed.
• Make sure that the mattress is the correct size for the bed.
• Make sure the feet are not in direct contact with the brackets of the pump as this may
cause damage to the skin.

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3Operation
3.1 Operation (how to get started)
1. Start the pump by pressing “1” (on), on the side of the pump.
2. The pump starts filling the mattress with air. The green light with the symbol will
flash during the inflation phase; it takes about 15 minutes for the mattress to fill with air.
3. When the symbol shows a steady green light, the mattress is ready to be used.
3.2 Comfort settings
The air pressure in the mattress can be adjusted according to the user’s comfort preference.
Always consult the prescriber or other authorised personnel for the appropriate setting.
Appropriate air pressure is selected using the knob (0–250 kg). The numbered scale guides
your selection. For sitting positions, we recommend that the pressure be raised by +25 kg.
Check using the hand check (see section 3.3).
3.3 Hand check (function control)
Hand check is performed to ensure that the mattress
system works properly and to ensure that the weight
setting is correct. Hand check should be performed
regularly; for S.A.M Pro, we recommend once per work
shift or every 8 hours, as well as after installation of the
system.
For manual systems hand check should also be
performed when moving from lying to seating position in
bed, in case of positioning changes and when changing
the comfort setting (and/or the weight setting).
Note!
• Make the bed with bedsheets.
•It is recommended to not use the product during x-ray.
•If the product has been stored in a cold space, wait some time using it.
Note!
• When the head end of the bed is raised, the pressure should be increased by 25 kg.
• When only part of the mattress is under load, e.g. for amputee users, the pressure
should be increased (by 1–2 steps). Then perform a hand check (see section 3.3).

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When using an overlay mattress system (CuroCell S.A.M.® PRO):
1a. Open the cover and insert a hand, with the palm facing up, between the overlay mattress
and the underlying mattress. The hand is inserted beneath the user’s sacrum (center of
mattress).
When using a full replacement mattress (CuroCell S.A.M.® PRO CF16)
1b. Open the cover and insert a hand, with the palm facing up, between the overlay mattress
and the underlying mattress. The hand is inserted beneath the user’s sacrum (center of
mattress).
2. Ensure there is a gap between the user and the underlying mattress so that the user does
not ‘bottom out’.
3. If you can feel the user’s sacrum resting in the palm of your hand, the gap is too small.
3.4 Cardiopulmonary rescitation (CPR)
In case of an emergency where CPR (cardiopulmonary
resuscitation) is necessary:
Quickly pull the CPR strap on the air tubes between the pump
and the mattress. Detach the quick connectors on the side of
the pump, for even faster deflation.
3.5 Low pressure
If there is abnormally low air pressure, see section 8 for Troubleshooting.
3.6 Transport function
Detach both the tubes from the pump and connect these together; this will put the mattress in
“Transport mode”. We recommend for this function only be used for a short period of time.
Note!
•Make sure that the mattress is filled, and that the system has adapted to
the user before performing a hand check.
•How to perform a hand check depends on which mattress is used.
•If the air pressure remains low, search for damage on the mattress
and the tubes. Repair when needed or contact the supplier.
Notera!
• After use, make sure that
the CPR-conntection is
properly attached.

4Product description
4.1 Pump
1. Comfort setting knob.
2. Control panel.
3. Casing, front.
4. Tube connector.
5. Power cable connector.
6. Power switch - Used to turn the pump
on or off. A green light indicates when the
pump is on.
7. Casing, back.
A. Hangers
B. Fuses (2 x T1A/250 V).
C. Label.
D. Air filter.

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4.2 Control panel
Comfort setting knob – Comfort settings
The comfort setting knob adjusts the air pressure in the mattress.
When the knob is turned clockwise, the air supply and pressure in
the mattress increase. When the knob is turned counter clockwise,
the air supply and pressure in the mattress decrease.
Sitting positions
When the user is sitting in the bed, we recommend that the pressure
be raised by +25 kg. Check using a hand check (see section 3.3).
Maximum pressure (Nursing mode)
With this function, the entire mattress is inflated and provides fixed
support. This function should be used when nursing the user, shifting
the user’s position or moving the user in or out of bed. This function
automatically reverts to the previous setting after about 30 minutes.
Information signal
If the mattress pressure is too low an audio-visual alarm is triggered.
Turning off the information signal
Turning off the information signal
Turn off the audio alarm by pressing the Audio off button. The audio
alarm is re-activated after seven minutes if the pressure has not
returned to normal. In the event of problems with notifications, see
section 8 for troubleshooting.
Normal pressure
The light shows steady when the mattress is ready to be used. It
flashes when air is being pumped into the mattress.

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4.3 Mattress
1. Cells/air bladder 2. Tubes 3. Tube holder 4. CPR (Rapid deflation)
5Reuse and cleaning
The product is reusable. Before using the product again for a new user, it is recommended to
clean the product. Follow the instructions below for cleaning and reconditioning. Consult your
hygiene manager or Care of Sweden for help and instructions if you are unsure.
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.
5.2 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 chlo- rine is used, we recommend a mixture of max 1 % (max 10% for cover
Stone).

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5.3 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 %.
5.4 Mattress
1. Disconnect the tube connector from the pump and remove the air from the mattress.
2. Remove the covers.
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 4.3.
Foam Core (S.A.M Pro CF16)
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.
Note!
• Check the whole product for damage each time it is cleaned. If damaged, it 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.

6Storage
It is advisable to store the mattress and pump in the product bag (accessory). Place the pump
so that it is protected by the mattress. Handle the stored product with care. Do not place any
heavy objects on top of it. The pump should be stored in a dry environment indoors and out of
direct sunlight.
7Maintenance
Service and maintenance must always be performed by Care of Sweden or one of its
authorized technicians. Only use spare parts approves by Care of Sweden. For more
information, see Service manual for CuroCell S.A.M PRO.
Following maintenance may be performed by user:
1. Check the power cable and power supply for damage and scratches.
2. Check the mattress cover to make sure it is undamaged and that covers and cells are
correctly assembled.
3. Check that air is coming from the outlets on the side of the pump.
4. Check that no tubes or connectors are damaged or pinched.
Contact the manufacturer or your local distributor for spare parts.
7.1 Air filter and fuse replacement
Air filter (A):
1. Loosen the small protective plate on the rear of the
pump using a screwdriver.
2. Remove the filter from the holder.
3. Insert the new filter in the holder, put the protective
plate back in place and secure using the screws.
Fuses (B):
1. Use a screwdriver to remove the fuse holder.
2. Replace the old fuse with a new one marked
T1A/250 V; note that there are two fuses.
3. Use a screwdriver to put the fuse holder back
in place.

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8Troubleshooting
If the problems keep occurring, please contact Care of Sweden or your local distributor.
Problem
Solution
The pump does not start
Check that the power cable is connected to a socket.
Check that all fuses are ok.
Pump is operating but the
mattress is not inflating
normally
Check that air is coming from the pump and that the
power cable is connected correctly. If the pump is
working but no air is coming out, the pump should be
serviced.
Check that the CPR valve is closed.
Check that the mattress and the mattress connector are
not damaged.
Check that the tubes are intact.
Check that the air filter is not blocked.
The user is “bottoming out”
The comfort settings might be incorrectly set. Adjust the
pressure and wait a few minutes. Check again using the
“hand check” (see section 3.3).
Check that the CPR valve is closed.
Mattress not stationary
Check that the mattress is secured to the underlying
mattress with the elastic straps or, if the mattress has
an integrated foam core (CuroCell S.A.M.® PRO CF16),
secured with the straps to the moving parts of the bed
base.
Noisy pump, or vibrations can
be felt
Check that the pump is correctly attached to the bed.
Resonance may occur in parts of the bed. Remove the
pump and listen to see whether there’s any difference.
This can be fixed by placing the pump on a level, sturdy
surface. Or by putting, for instance, a towel between the
pump and the bed.

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9Technical specification
Care of Sweden reserves the right to modify the product specification at any time.
9.1 Standards
The system has been tested and approved according to following standards where applicable
demands are fulfilled:
ICE 60601-1 EN ISO 10993 ISO 3746
IEC 60601-1-1-2 EN 12182 ISO 11201
IEC 60601-1-1-11 EN 597-1
ICE 60601-1-6 EN 597-2
ICE 62304 EN ISO 14971
9.2 Marking
The mattress is labelled with product name production date, article number, size, care and wash
instructions, EAN-bar code, as well as space for own labelling. The product also displays which
side is up/down and head/foot.
PUMP
SPECIFICATION
Model
CuroCell S.A.M.® PRO
Voltage
110-120 V, 60 Hz, 220-240 V, 50Hz
Current
Max 10 W
Fuse type
T1A/250V
Dimensions (LxWxH)
26 x 8 x 13 cm
Weight
1.5 kg
Sound level, max
ISO 3746:2010 - 39 dBA
EN ISO 11201:2010 - 22 dBA
Ambient environment
Temperature
Operation: 5 °C ˜ 40 °C
Storage: -25 °C ˜ 70 °C
Shipping: -25 °C ˜ 70 °C
Humidity
Operation & Transport: 5 % ˜ 95 %
non-condensing
Storage: 10 % ˜ 80 % non-
condensing
Atmospheric
pressure
Operation: 700 hPa to 1060 hPa
Storage & Transport 500 hPa to
1060 hPa
Classification
Class II, Type BF, IP21

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9.3 Symbol Key
Symbols to convey medical device information
CE-marked in accordance with
Medical Device Regulation (EU)
2017/745
Manufacturer
UDI Medical Device
Distributor
Symbols for traceability and product information
Item number Type BF
IP class (Enclosure class)
Class II Equipment (double
insulated). Indicated on the
power supply.
Symbols for user information
Recommended user weight XXXX-XX-XX Year-month-day
Counteracts shear force User information - category
Placed directly on the bed base User information - category
Foot placement Can be rotated
Heel function Can be turned
The mattress should be used
with the user lying lengthways
Place on top of existing
mattress
Warning of electrical voltage
Read the instructions for
use
Read the instructions for use

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Symbols for cleaning and recycling
Machine wash at 95 °C Do not iron
Do not machine wash Chlorine
Wipe clean Tumble dry
Do not dry clean Do not tumble dry
Drip dry
Do not dispose of with
household waste
Recycling Machine wash at 70°C

10 Other information
10.1 Recommended lifetime of the product
The estimated lifetime of this product is 5 years.
10.2 Disassembly and recycling
Except for certain parts of the pumps, energy recovery is possible for almost all material in
CuroCell® products through incineration in waste incineration facilities.
Pump: A used CuroCell® pump must not be disassembled. Instead, it should be taken to a
recycling centre. The product is sorted as “electronic waste”.
Mattress: A used CuroCell® mattress should be taken to a recycling centre. The product is
sorted as “combustible waste”.
For more information, please contact Care of Sweden or your local distributor.
10.3 Returns
Contact Care of Sweden or your local distributor before returning the product.

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Your own notes

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Manufactured by
Contact:
Phone: + 46 771 106 600
Fax: + 46 325 128 40
Email: [e-mail]
Internet: www.careofsweden.com
Address:
Care of Sweden AB
P.O. Box 146
SE-514 23 Tranemo
SWEDEN
Visit address:
Fabriksgatan 5A
SE-514 33 Tranemo
SWEDEN
Cargo address:
Byns väg 4A
SE-514 33 Tranemo
SWEDEN
Distributed by:
Care of Sweden is a trademark of Care of Sweden AB
© Care of Sweden AB, 2022