CuroCell AREA Zone Hybrid mattress Instructions for Use June 2022

10.3

Table of contents

WARNINGS- AND SAFETY PRECAUTIONS ... 3

1

2 3

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... 5 3.1

Hand check (function control) ... 5

3.2

Operations Evac Sheet ... 5

4

PRODUCT ... 6

5

REUSE AND CLEANING ... 7 5.1

Mattress cover and inner cover ... 7

5.2

Foam core ... 7

5.3

Air cells ... 7

6

Storage ... 8

7

Maintenance... 8 7.1 General ... Fel! Bokmärket är inte definierat.

8

Troubleshooting ... 8

9 Technical specification ... Fel! Bokmärket är inte definierat. 9.1

Standards ... 6

9.2

Marking ... 8

9.3

Symbol Key... 9

10

Other information ...11 10.1 product

Recommended lifetime of the 11

10.2

Disassembly and recycling ... 11

Returns ... 11

10.4 Combinations of products ... Fel! Bokmärket är inte definierat.

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. The mattress is protected by a hygiene cover; avoid using multiple hygiene covers as this can affect the vapor permeability of the mattress. 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 when using bed rails. 5. Always make sure the mattress has the right size. 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. Prevent damage to the hygiene cover from sharp objects. 8. 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. 9. Follow the operations and maintenance instructions carefully in order to prevent bodily injuries, as well as damages to the product or other equipment. 10. This mattress is unsuitable for use during x-ray examinations because of the risk of blurred images or artefacts that may lead to diagnostic errors.

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 mattress is intended to be used by all kind of users, including lay persons. The mattress is 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 including category 3 (in association with an individualised plan of care). The user weight is up to 230 kg. There are no known contraindications. Care of Sweden’s clinical benefits and claims for CuroCell® hybrid mattresses 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. • 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.

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. 1. Put the mattress on the bed frame and correct the cover if necessary. 2. Let the mattress sit on the bed for a few minutes before using it. Note! • It is recommended to make the bed with a bed sheet.

3

Operation

3.1

Hand check (function control)

3.2

Operations Evac Cover

The hand check is used to ensure that the mattress is working properly. This must be performed regularly; we recommend once per shift, or every eight hours. Open the cover and insert your hand between the air cells directly underneath the user’s pelvic region, use a vertical hand. There should be a clearance of 2-3 fingers between mattress base and the user.

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 Evac Cover 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.

4

Product description

Care of Sweden reserves the right to modify the product specification at any time. The mattress is a combination of foam and air that operates without electricity.

1. Label “Head end” 2. Foam core 3. Tubing system

4.1

Standards

4. Air cells 5. Foam top part

The system has been tested and approved according to following standards where applicable demands are fulfilled: SS-EN ISO 20342, SS-EN ISO 14971, SS-EN ISO 10993, EN 597-1, EN 597-2.

5

Reuse and cleaning

5.1

Mattress cover and inner cover

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.

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. Carefully follow local instructions and usage instructions for the cleaner.

Multi-layer covers should be divided before washing. Wash with similar colours.

5.2

Foam 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.

5.3

Air cells

1. Remove the covers. See instructions in chapter 5.1 for cleaning covers. 2. Carefully remove the air cells from the foam core. Remove the cell holder from the cells. 3. Place the air cells and the tubes on a clean area which is suitable for washing. 4. Wipe off the cells, all tubes with a mild cleaning solution for this purpose such as: alcohol withor without tensides, Isopropanol 70 %, oxidating solutions or chlorine max 1 %. 5. Replace the cells into the cell holder. Place the air cells back into the foam core. Check that all the tubes and connectors are secure and tight, before closing the cover. 6. Wipe off work surfaces with alcohol-based disinfectant/cleaner intended for this purpose.

Note! • Check the hygiene cover, cells and hoses each time the product 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.

6

Storage

7

Maintenance

Store the mattress on a flat surface or carefully rolled/folded with the zipper closed. Always 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 things that can damage it. Avoid direct exposure of sunlight. If the mattress is to be stored more than 3 months, we recommend it is stored on a flat surface (not folded or rolled up).

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.

8

Troubleshooting

If the problems keep occurring, please contact Care of Sweden or your local distributor. Problem The user is “bottoming out”

9 9.1

Solution Open covers and check cells and tubing Check again through hand check (see 3.1)

Marking and Symbol key Marking

The mattress is labelled with product name, production date, item 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.

9.2

Symbol Key

Symbols to convey medical device information CE-marked in accordance with Medical Device Regulation (EU) 2017/745

Manufacturer

Medical Device

UDI

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

Do not rotate

Heel function

Do not turn around

The mattress should be used with the user lying lengthways

Read the instructions for use

Read the instructions for use

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

10 Other information 10.1 Recommended lifetime of the product The estimated lifetime of this product is 5 years.

10.2 Disassembly and recycling

The mattress is recyclable as combustible waste.

10.3 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: [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