CuroCell S.A.M. PRO and PRO CF16 Constant low pressure reactive air mattress system Instructions for Use June 2022

Table of contents

10

Other information ... 17 10.1Recommended lifetime of the product 17

WARNINGS- AND SAFETY PRECAUTIONS 3

10.2

Disassembly and recycling ... 17

1

10.3

Returns ... 17

2 3

4

5

Introduction ... 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

Assembly and installation ... 5 Operation ... 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

Product description ... 8 4.1

Pump... 8

4.2

Control panel ... 9

4.3

Mattress ... 10

Reuse and cleaning ...10 5.1

Cleaning pump ... 10

5.2

Mattress cover ... 10

5.3

Inner cover ... 11

6

Storage ...12

7

Maintenance...12 7.1

8 9

Air filter and fuse replacement ... 12

Troubleshooting ...13 Technical specification ...14 9.1

Standards ... 14

9.2

Marking ... 14

9.3

Symbol Key... 15

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.

1

Introduction Always read the instructions for use prior to use.

1.1

General information

1.2

Intended purpose

1.3

Intended user

1.4

Intended user environment

1.5

Indications

1.6

Contraindication

1.7

Clinical benefit

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. The mattress is intended to be used for prevention and as an aid in the treatment of pressure ulcers/pressure injuries (PU/PI).” The mattresses are intended to be used by all kind of users, including lay persons. The mattresses are intended to be used in all kinds of healthcare environments, including home care. 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 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. 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.

2

Assembly 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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3

Operation

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.

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.

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).

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).

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).

6

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.

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

3.6

Transport function

Notera! • After use, make sure that the CPR-conntection is properly attached.

If there is abnormally low air pressure, see section 8 for Troubleshooting.

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.

7

4

Product 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.

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

5

Reuse and cleaning

5.1

Cleaning pump

5.2

Mattress cover

1. Cells/air bladder

2. Tubes

3. Tube holder

4. CPR (Rapid deflation)

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.

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.

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

5.4

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 %.

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.

11

6

Storage

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.

7

Maintenance

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.

8

Troubleshooting

If the problems keep occurring, please contact Care of Sweden or your local distributor. Problem The pump does not start

Solution Check that the power cable is connected to a socket.

Pump is operating but the mattress is not inflating normally

Check that all fuses are ok. 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.

The user is “bottoming out”

Mattress not stationary

Noisy pump, or vibrations can be felt

Check that the air filter is not blocked. 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. 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. 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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9

Technical specification

Care of Sweden reserves the right to modify the product specification at any time. PUMP Model

SPECIFICATION CuroCell S.A.M.® PRO

Voltage Current Fuse type Dimensions (LxWxH) Weight Sound level, max

110-120 V, 60 Hz, 220-240 V, 50Hz Max 10 W T1A/250V 26 x 8 x 13 cm 1.5 kg ISO 3746:2010 - 39 dBA

Ambient environment

EN ISO 11201:2010 - 22 dBA Operation: 5 °C ˜ 40 °C Storage: -25 °C ˜ 70 °C Shipping: -25 °C ˜ 70 °C Operation & Transport: 5 % ˜ 95 % non-condensing Storage: 10 % ˜ 80 % noncondensing Operation: 700 hPa to 1060 hPa

Temperature

Humidity

Atmospheric pressure

Storage & Transport 500 hPa to 1060 hPa Class II, Type BF, IP21

Classification

9.1

Standards

9.2

Marking

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 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.

14

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

15

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

16

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.

Your own notes

18

Manufactured by

Contact:

Phone: + 46 771 106 600 Fax: + 46 325 128 40 Email: [email protected] 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