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

Instructions for use
2020-12-08
CuroCell S.A.M.®
Constant low pressure reactive air mattress system
Instructions for use item number: 95-001298

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Table of contents
WARNINGS AND SAFETY PRECAUTIONS 3
1. Introduction 4
2. Product description 5
3. Installation and start-up 7
4. Reuse, cleaning and reconditioning 9
5. Storage 11
6. Maintenance 11
7. Troubleshooting 11
8. Technical description 12
9. Spare parts 14
10. Options and accessories 15
11. Warranty 16
12. Other information 17
13. Own notes 18

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WARNINGS AND SAFETY PRECAUTIONS
Read all instructions prior to use
WARNING! To minimise the risk of fire, electric shocks or physical injury:
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 (e.g.
pump and mattress), 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 or 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. NOTE: Be particularly aware of trapping damage when using bed rails.
5. Never use the product if the pump power cable or plug is defective, the pump casing
is damaged, or it is not functioning properly. Contact a 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.
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 supplied with handles on the long sides, theses handles are only to be
used for lifting and moving the mattress itself. All other use will be at your own
responsibility and is not covered by the product warranty.
12. 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.

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1. Introduction
CuroCell S.A.M.® is a constant low pressure reactive air mattress system that can be used in all
kinds of caring environments and it is very functional and cost effective.
Always read the instructions for use prior to use.
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 8.2 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). The system can also be used in pain
therapy.
1.3 Indications
For users with pressure ulcers/pressure injuries (PU/PI) up to and including category 2 ¹. 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 three
versions. CuroCell S.A.M.® and CuroCell S.A.M.® CF10 are overlay mattresses and are placed
on an underlying mattress. CuroCell S.A.M.® CF16 is a replacement mattress placed directly on
the bed base. The recommended user weight is up to 200 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 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’ guidelines.
Mattress guide
This guide provides guidance to personnel and prescribers when choosing a mattress from
Care of Sweden. CuroCell S.A.M® is a mattress in function group B. This information can be
found on our website www.careofsweden.com or you can order a copy from our Customer
services by sending your details to [e-mail].
2. Product description
2.1 Pump
1. Front panel
2 Tube connections, with quick connection and without quick connection
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.
•Be careful when using bed rails or other protection on the bed so that the mattress
does not become crushed or damaged.
•The mattress must not be lifted with a person lying on it or used for any other type of
transport other than a possible evacuation using an evacuation sheet.
•This mattress is unsuitable for x-ray examinations because of the risk of blurred images
or artefacts that may lead to diagnostics errors.

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Back side
1. Bed hooks
2. Main power switch (side)
For switching on/off the pump.
Green lamp indicates when the pump is running.
3. Power cable
2.2 Front panel
Comfort settings
The comfort setting 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.
Appropriate air pressure is set between 1 and 8. The table on the
pump gives guidance.
2.3 Mattress
1. Cells/air bladder 2. Tubes 3. Tube holder 4. CPR (Rapid deflation)
2.4 Other parts
Hygiene cover
Inner cover Soft (accessory)
Transport and Storage Bag (accessory)
Pump bag (accessory)
Integrated foam core (only CuroCell S.A.M.®CF16)
1 2 3 4

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3. Installation and Start-up
3.1 Installation
When unpacking the mattress, check that none of the parts are damaged. In the event of
damage, 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.® 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.
NOTE! A pump bag is
available as an option.
3. Connect the mattress'
air hoses to the side of
the pump. If 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 in the power cable into an
approved outlet (220 V).
3.2 Start-up and settings
NOTE! Always read the instructions for use prior to use.
1. Start the pump by pressing ’1’ (on), on the side of the pump. The green light is lit.
2. The pump starts filling the mattress with air. It takes approximately 15-20 minutes.
NOTE!
•Make up the bed with sheets to increase user comfort.
•Check that the CPR-valve is closed.

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3.3 Comfort settings
The air pressure in the mattress can be adjusted according to the
user´s desire for comfort. Always consult the prescriber or other
authorised personnel for the appropriate setting.
Adjust the pressure with the comfort setting knob according to
the table on the pump.
3.4 Handcheck (function control)
Hand check is used to ensure that the mattress is properly
inflated. This should be done regularly, once per shift, after
changing the position in the bed or changing the comfort settings.
Open the cover. Place a flat hand under the air cells directly
underneath the user’s pelvic region and make sure that the user
does not lay directly on the underlying mattress. There should be
about 1-2 fingers margin.
If you can feel the user´s body resting on your hand you need to increase the comfort settings
to next highest step. Wait 10 minutes and perform a new hand check.
3.5 CPR
In case of an emergency where CPR (cardiopulmonary resuscitation) is
necessary: Rapidly pull the CPR band on the tubes between the pump
and the mattress. Remove the tube connections on the side of the pump,
for even faster deflation.
Note! Make sure that the CPR connector is properly connected after use.
3.6 Low pressure
By an abnormally low air pressure, see chapter 7 for troubleshooting.
NOTE!
•When the head end of the bed is raised, the pressure should be increased at least one
(1) step.
•For amputated users, when only part of the mattress is under load, the pressure should
be increased by 1-2 steps.
•Recommended users’ weight is up to 200 kg.

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3.7 Transport function
If the pump and mattress are equipped with quick connection and the user must be moved in
bed, the tubes can be connected together (detached from the pump) and the mattress is put
in “transport mode”. We recommend using this mode only for short periods of time.
4. 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.
4.1 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).
WARNING!
If the air pressure remains low, search for damages on the mattress and the tubes. Repair
when needed or contact Care of Sweden or your local distributor.

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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 %.
4.2 Reconditioning
PUMP
See section 4.1 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 be- come loose from the tubes,
these must be replaced accord- ing to the drawing in section 4.2.
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.
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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5. Storage
It is advisable to store the mattress and pump in the product bag (accessory). Handle the
packed product very carefully. Do not place any heavy objects on top of it.
6. Maintenance
1. Check the power cable and plug for damages and scratches.
2. Check the mattress cover to make sure it is undamaged and that cover and cells are
correctly assembled.
3. Check that air is coming from the outlets on the side of the pump.
4. Check for damaged or pinched tubes and connectors.
Contact Care of Sweden or your local distributor for spare parts.
7. Troubleshooting
The pump does not start Check that the power cable is connected to an electrical
outlet. Check that all fuses are OK.
The user lies directly Pressure might be incorrectly set. Adjust it according to the
on the bed weight table and wait a few minutes. Check again using the
‘hand check’, see chapter 3.4.
Check that the CPR-valve is closed.
The mattress moves around Check that the mattress is secured with the elastic bands to
the underlying mattress. Or, if the mattress has an integrated
foam core (CuroCell S.A.M.® CF16), secured by using the straps
on the cover to fasten the mattress to the bed base.
The pump makes a noise, Check how the pump is hung on the bed. Remove the pump
or vibrates and listen whether this makes a difference. Can be resolved by
putting the pump on a flat, steady surface or by placing a
towel between the pump and bed. Pump bag (accessory) can
also be used.
If your questions are not answered by the above information, please contact Care of Sweden
or your local distributor for further assistance.
Problem Solution

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8. Technical description
8.1 Technical specification
PUMP
SPECIFICATION
Model
CuroCell S.A.M.®
Voltage
220 V-240 V, 50 Hz
Current consumption
0.05 A
Fuse type
T1A/250V
Dimensions (LxWxH)
25 x 12.5 x 8.5 cm
Weight
1.4 kg
Surroundings
Temperature
Operations: 10°C ˜ 40°C
Storage: -15°C ˜50°C
Shipping: -15°C ˜70°C
Humidity
Operations: 10%
˜
90% non-condensing
Storage: 10% ˜90% non-condensing
Athmospheric pressure
700hPa-1013,25hPa
Classification
Class II, Type BF, IP21
MATTRESS
SPECIFICATION
Model
CuroCell S.A.M.®,/ CuroCell S.A.M.® CF10 /CuroCell
S.A.M.® CF16
Dimensions (WxLxH)
80/85/90/105/120x200/210x10/16 cm
Weight
2.7 kg
NOTE! Care of Sweden reserves the right to modify the product specification at any time.
8.2 Standarder
Systemet har testats och godkänts enligt följande standarder är tillämpliga krav är uppfyllda.
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
EN 41126
8.3 Labelling
The mattress are 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.
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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8.4 Symbol Definitions
Type BF
Class II equipment
(Double Insulated)
The mattress should only
be used lying in
the
lengthwise direction on the
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 acc. to Medical
Device Regulation MDR
(2017/745)
Machine wash at 95 °C
Directly on bed base
Tumble dry
Place on top of
existing mattress
Do not iron
Recommended user weight
User information
–
category
Wipe off
Year-Month-Day
Counteract shear force
Item no
XXXX-XX-XX
Group of function
Do not wash
Manufacturer
Not in domestic refuse,
follow recycling instructions
Foot placement
IP-class
(Ingress Protection Rating)
Heel function
Distributed by
UDI
Medical Device

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9. Spare parts
Covers, CuroCell S.A.M® and CuroCell S.A.M® CF10
Cover Steel, blue Cover Stone, grey
Size Art. No Art. No
80x200 cm 294-080200 290-080200
80x210 cm 294-080210 290-080210
85x200 cm 294-085200 290-085200
85x210 cm 294-085210 290-085210
90x200 cm 294-090200 290-090200
90x210 cm 294-090210 290-090210
105x200 cm 294-105200 290-105200
105x210 cm 294-105210 290-105210
120x200 cm 294-120200 290-120200
120x210 cm 294-120210 290-120210
CuroCell S.A.M.® CF16
Top part Olivia Top part Stone Bottom part CuroCell
Size Art. No Art. No Art. No
80x200 cm 431-080200 452-080200 CC-905610
80x210 cm 431-080210 452-080210 CC-905611
85x200 cm 431-085200 452-085200 CC-905612
85x210 cm 431-085210 452-085210 CC-905613
90x200 cm 431-090200 452-090200 CC-905614
90x210 cm 431-090210 452-090210 CC-905615
105x200 cm 431-105200 452-105200 CC-905616
105x210 cm 431-105210 452-105210 CC-905617
120x200 cm 431-120200 452-120200 CC-905618
120x210 cm 431-120210 452-120210 CC-905620
Air cells incl. tubes with CPR Air cells incl. tubes with CPR and quick connection
Art. No Size Art. No Size
CC-250570 80x200x10 cm CC-250630 80x200x10 cm
CC-250571 80x210x10 cm CC-250631 80x210x10 cm
CC-250573 85x200x10 cm CC-250633 85x200x10 cm
CC-250574 85x210x10 cm CC-250634 85x210x10 cm
CC-250576 90x200x10 cm CC-250636 90x200x10 cm
CC-250577 90x210x10 cm CC-250637 90x210x10 cm
CC-250578 105x200x10 cm CC-250638 105x200x10 cm
CC-250580 105x210x10 cm CC-250639 105x210x10 cm
CC-250579 120x200x10 cm CC-250640 120x200x10 cm
CC-250581 120x210x10 cm CC-250641 120x210x10 cm
Art.No Description
CC-250101-E3 CuroCell S.A.M.®, pump without quick connection
CC-250102 CuroCell S.A.M.®, pump incl. quick connection
CC-908032 Tubing set incl, CPR
If other spare parts are needed, please contact Care of Sweden or your local distributor for
further assistance.

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10. Options and accessories
10.1 Options
Inner cover Soft
Enhances the comfort further, can also be used for very sensitive users. This is included for
CuroCell S.A.M.® CF10 and CuroCell S.A.M.® CF16. Place the air cells inside the cover with the
soft foam side up.
Sturdy transportation bag
Transportation and storage bag.
Cover
With welded seams.
10.2 Accessories
Cover, Curocell S.A.M® and CuroCell S.A.M® CF10 CuroCell S.A.M.® CF16
Inner cover Soft Inner cover Soft with foam pocket
Art. No Size Art. No Size
CC-928040 80x200 cm CC-928060 80x200 cm
CC-928041 80x210 cm CC-928061 80x210 cm
CC-928043 85x200 cm CC-928063 85x200 cm
CC-928044 85x210 cm CC-928064 85x210 cm
CC-928046 90x200 cm CC-928066 90x200 cm
CC-928047 90x210 cm CC-928067 90x210 cm
CC-928048 105x200 cm CC-928068 105x200 cm
CC-928050 105x210 cm CC-928070 105x210 cm
CC-928049 120x200 cm CC-928069 120x200 cm
CC-928051 120x210 cm CC-928071 120x210 cm
Art.No Description
CC-9091 Transportation and Storage Bag to CuroCell S.A.M.® 80-90cm
CC-9093 Transportation and Storage Bag to CuroCell S.A.M.® CF10 80-105 cm
and CuroCell S.A.M.® 105-120 cm
CC-9094 Transportation and Storage Bag to CuroCell S.A.M.® CF10 120 cm
58-900909 Transportation and Storage Bag to CuroCell S.A.M.® CF16 80-90 cm
58-900905 Transportation and Storage Bag to CuroCell S.A.M.® CF16 105-120 cm
CC-9098 Pump bag, black
10.3 Other accessories
To ensure the best level of comfort, we recommend use of accessories from Care of Sweden
since our products are designed to work well together. Please contact Care of Sweden or your
local distributor for accessories or more information on our products.

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11. Warranty
11.1 Scope
This CuroCell® system is covered by a 2-year warranty for manufacturing defects. The warranty
does not apply to normal wear and tear or damage due to negligence or improper
handling/care.
11.2 Service and repairs
This CuroCell® mattress is a medical device, in accordance with Medical Device Regulation
MDR (2017/745), that is used as an aid in preventing and treating pressure ulcers/pressure
injuries. For this reason, we recommend that the product be regularly serviced and inspected
to maintain functionality and performance. Like other technical devices, a pump that is
properly cared for works better and lasts longer.
During the expected lifespan of the product, some parts of the pump will experience wear and
will require servicing by a certified service technician in order to retain good functionality and
performance. The scope of the servicing and the servicing intervals will depend on how often
and to what degree the product is used.
Service and maintenance must always be performed by Care of Sweden or one of its
authorised technicians. Only use spare parts that have been approved by Care of Sweden. Use
of non-approved spare parts invalidates the warranty.
A warranty claim must be submitted to Care of Sweden before the product is returned.
Please contact Care of Sweden or your local distributor if you have questions regarding
warranty and service.
11.3 Lifetime
This product´s lifetime is estimated to be 5 years.

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12. Other information
12.1 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. It must instead be taken to a recycling
centre and sorted as electronic waste.
Mattress:
A used CuroCell®mattress must be taken to a recycling centre and sorted as combustible
waste.
For more information contact Care of Sweden or your local distributor.
12.2 Returns and complaints
Complaints are to be reported to the distributor. Return of a product shall follow the
distributor’s instructions and can only be done after the complaint has been reported.
Damages due to the transportation should be reported to the transportation agent.

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13. Own notes

19

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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 and CuroCell S.A.M. are trademarks of Care of Sweden AB
© Care of Sweden AB, 2020