Care of Sweden PRIMA BM User manual

EN
Instructions for use
2022-06-23
Standard mattresses
PRIMA BM
PRIMA 6
Optimal M3
Optimal BOB
Optimal Junior
Instructions for use item number: 95-001102-EN0000

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Table of contents
WARNINGS AND SAFETY PRECAUTIONS ................................................................................ 2
1Introduction ................................................................................................................. 3
1.1 General information.......................................................................................................3
1.2 Intended purpose ...........................................................................................................3
1.3 Intended user .................................................................................................................3
1.4 Intended use environment .............................................................................................3
1.5 Indications......................................................................................................................3
1.6 Contraindications ...........................................................................................................3
1.7 Clinical benefit................................................................................................................3
2Assembly and installation ............................................................................................ 4
3Operation..................................................................................................................... 5
3.1 Operation Evac cover .....................................................................................................5
4Product description...................................................................................................... 6
4.1 PRIMA BM ......................................................................................................................6
4.2 PRIMA 6..........................................................................................................................6
4.3 Optimal M3 ....................................................................................................................6
4.4 Optimal Junior................................................................................................................6
4.5 Optimal BOB...................................................................................................................6
5Reuse and cleaning ...................................................................................................... 7
5.1 Mattress cover hygiene..................................................................................................7
5.2 Mattress cover quilt .......................................................................................................7
5.3 Mattress core .................................................................................................................7
6Storage ........................................................................................................................ 8
7Maintenance................................................................................................................ 8
8Marking and symbol key .............................................................................................. 8
8.1 Marking..........................................................................................................................8
8.2 Symbol Key .....................................................................................................................9
9Other information...................................................................................................... 10
9.1 Recommended lifetime of the product.........................................................................10
9.2 Disassembly and recycling............................................................................................10
9.3 Returns.........................................................................................................................10

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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:
1The 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.
2DO 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.
3Position 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.
4Always make sure the mattress has the right size.
5The mattresses are protected with a hygiene cover. Avoid using multiple hygiene covers as
this can affect the vapor permeability of the mattress.
6The hygiene cover does not allow liquid or air to penetrate but is vapor permeable. Make
sure that the user is positioned correctly to avoid the risk of suffocation. Monitor a user
with special needs continuously.
7Prevent damage to the hygiene cover from sharp objects.
8Mattresses cover is supplied with handles on the long sides, theses handles are only to be
used lifting and moving the mattress itself. All other use will be at your own responsibility
and is not covered by the product warranty.
9Do not put the product in direct sunlight.

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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 alleviation of pressure
ulcers and 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 use environment
The mattresses are intended to be used in all kinds of healthcare environments,
including home care.
1.5 Indications
Suitable for persons with increased risk for pressure ulcers/injuries (PU/PI).
1.6 Contraindications
There are no known contraindications.
1.7 Clinical benefit
The clinical benefit for the mattresses included in this instruction for use are:
• Safety
• Comfort
• Easy to handle

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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.
1Unpack the product carefully, do not use any sharp objects.
2Correct the cover. Mattresses that are delivered with the divisible Evac-cover are packed
with the top part folded inside the mattress. Lay out the top part and close the zipper.
3The mattress should lay unpacked on a flat surface for about 2 hours before it is used. If
necessary, the mattress can be used immediately.
Note:
•It is recommended to use a bedsheet on the mattress.
•It can take up to a week before the mattress has resumed to its full size after the
compression.

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3Operation
When the steps in section 2 have been performed, the mattress is ready to use.
3.1 Operation Evac cover
This section will only explain how to use the evac cover. Refer to your local evacuation
routines to perform the whole evacuation safely.
Evac cover is a mattress cover with a built-in function for evacuation of bed-bound users. The
Evac cover is equipped with three handles on the head and foot end. On the sides, there are
handles with velcro straps. These straps are to be used to fixate the user to the mattress
before commencing the evacuation. The straps are folded in the protective pockets on the side
of the mattress with the ends sticking out to ensure that they are easy to pull out.
Operation
1. Pull out and fasten the Velcro straps so that the mattress forms a
tube around the user.
2. Use the outer handles at the foot end of the mattress and turn
the mattress out from the bed.
3. Slowly pull the user down on the floor.
4. Pull on the outer handles at the foot end of the mattress.
5. The user may now be moved, refer to local evacuation routines.
Note:
•If the velcro straps are not used, there is a risk of the user sliding/rolling down from the
mattress.
•Pulling at the foot end reduces the strain on the puller, meaning faster and safer
evacuation is possible.
•The arms of the user shall be inside of the velcro straps. This reduces the risk of the user
grabbing hold to something out of fear.
*

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4Product description
The system has been tested and approved according to following standards where applicable
demands are fulfilled: SS 876 00 01, SS 876 00 02, SS 876 00 04, SS 876 00 11, SS 876 00 20, SS-
EN ISO 20342, SS-EN ISO 14971, SS-EN ISO 10993-1, EN 597-1, EN 597-2.
4.1 PRIMA BM
PRIMA BM is a reversible overlay mattress that offers comfort and easy handling.
Core: HR foam 35 kg/m³ (High Resilience)
Height: 6 cm
Cover: Marin and Quilt
User weight: 0-130 kg*
*Please note that the underlying mattress affects the overall function including the
recommended user weight.
4.2 PRIMA 6
PRIMA 6 is a reversible mattress distance/elevation pad for placement under an overlay
mattress.
Core: HR foam 35 kg/m³ (High Resilience)
Height: 6 cm
Cover: Marin and Quilt
User weight: 0-130 kg (to not disclose when it is used with another mattress)
4.3 Optimal M3
Optimal M3 is a standard replacement mattress for all types of healthcare environments.
Core: HR foam 50 kg/m³ (High Resilience)
Height: 12 cm
Cover: Marin, Marin/Evac
User weight: 0-130 kg
4.4 Optimal Junior
Optimal Junior is a reversible standard replacement mattress.
Core: HR foam 30 kg/m³ (High Resilience)
Height: 5 cm
Cover: Marin
User weight: 0-20 kg
4.5 Optimal BOB
A mattress for emergency healthcare, operating and
stretcher trolleys. The mattress is equipped with our
patented sit function DuoCore®.
Core: HR foam 50 kg/m3
Height: 9 cm
Cover: BOB
User weight: 0-130 kg

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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 Mattress cover hygiene
Covers can be wiped off with a mild cleaning solution for this purpose such as: alcohol
with or without tensides, Isopropanol 70 %, oxidating solutions or chlorine max 1 %.
Excrements and blood spots must be removed immediately with cold water.
Multi-layer covers should be divided before washing. Wash with similar colours.
If chlorine is used, we recommend a mixture of max. 1%.
5.2 Mattress cover quilt
The cover can be machine washed and tumble dried.
5.3 Mattress core
Clean the affected area with a mild cleaning solution for this purpose such as: alcohol
with or without tensides, Isopropanol 70 %, oxidating solutions or chlorine max 1 %.
Press out the water carefully. Let the foam core dry in a warm, ventilated area, without direct
exposure of sunlight. The foam core needs to be completely dry before it is used again.
Note:
•Check the product every time it is being cleaned. If damaged, it must be replaced or
repaired. If the product is equipped with an Evac cover, handles and straps also need to
be checked regularly.

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6Storage
Store the mattress on a flat surface or carefully rolled/folded with the zipper closed. Store at
room temperature in a dry area. Make sure the mattress is stored where it will not be exposed
to thrusts, hits or other damages. Avoid direct exposure to sunlight. If the mattress is to be
stored more than 3 months, it is recommended to store it on a flat surface (not folded or
rolled up).
7Maintenance
The product needs no other service or maintenance than cleaning as described in section 5.
8Marking and symbol key
8.1 Marking
The product is labelled with product name, production date, item number, size, care and wash
instructions, EAN-bar code as well as space for own labelling. It is also marked with indications
on which side to place upwards.

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8.2 Symbol Key
Symbols to convey medical device information
CE-marked in accordance with
Medical Device Regulation (EU)
2017/745
Manufacturer
Medical Device Distributor
UDI
Symbols for traceability and product information
Item number
Symbols for user information
Recommended user weight XXXX-XX-XX Year-month-day
Directly on bed base
Place on top of existing
mattress
Can be rotated Can be turned
Place underneath Counteract shear force
Read the instructions for use Place on top
Read the instructions for use
Symbols for cleaning and recycling
Machine wash at 95 °C Machine wash at 70 °C
Do not wash
Chlorine
Wipe clean Tumble dry
Do not dry clean Do not tumble dry
Drip dry Do not iron
Recycling

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9Other information
9.1 Recommended lifetime of the product
The estimated lifetime of PRIMA BM, PRIMA 6 and Optimal BOB is 3 years.
The estimated lifetime of Optimal Junior and Optimal M3 is 5 years.
9.2 Disassembly and recycling
The product is fully recyclable and should be sorted as combustible waste. No dismantling is
needed.
9.3 Returns
Contact Care of Sweden or your local distributor before returning the product.

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, CuroCell, Curera and DuoCore are trademarks of Care of Sweden AB
© Care of Sweden AB, 2022