INVACARE 5055050452946 Pressure Relieving Mattress Topper User Manual

: June 4, 2024
: INVACARE

Invacare® Propad®

INVACARE Pressure Relieving Mattress Topper 01

1 General

1.1 Introduction

This user manual contains important information about the handling of the product. To ensure safety when using the product, read the user manual carefully and follow the safety instructions.

Invacare reserves the right to alter product specifications without further notice.

Before reading this document, make sure you have the latest version. You find the latest version as a PDF on the Invacare website.

If you find that the font size in the printed document is difficult to read, you can download the PDF version from the website. The PDF can then be scaled on screen to a font size that is more comfortable for you.

In case of a serious incident with the product, you should inform the manufacturer and the competent authority in your country.

1.2 Symbols in this Document

Symbols and signal words are used in this document and apply to hazards or unsafe practices which could result in personal injury or property damage. See the information below for definitions of the signal words.

WARNING
Indicates a hazardous situation that could result in serious injury or death if it is not avoided.

CAUTION
Indicates a hazardous situation that could result in minor or slight injury if it is not avoided.

IMPORTANT
Indicates a hazardous situation that could result in damage to property if it is not avoided.

Tips and Recommendations
Gives useful tips, recommendations and information for efficient, trouble-free use.

1.3 Compliance

Quality is fundamental to the company’s operation, working within the disciplines of ISO 13485.

This product features the CE mark, in compliance with the Medical Device Regulation 2017/745 Class I. The launch date of this product is stated in the CE declaration of conformity.

We are continuously working towards ensuring that the company’s impact on the environment, locally and globally, is reduced to a minimum.

We only use REACH compliant materials and components.

1.4 Warranty Information

We provide a manufacturer’s warranty for the product in accordance with our General Terms and Conditions of Business in the respective countries.

Warranty claims can only be made through the provider from whom the product was obtained.

1.5 Limitation of Liability

Invacare accepts no liability for damage arising from:

Non-compliance with the user manual
Incorrect use
Natural wear and tear
Incorrect assembly or set-up by the purchaser or a third party
Technical modifications
Unauthorised modifications and/or use of unsuitable spare parts

This manual MUST be given to the user of the product.
BEFORE using this product, this manual MUST be read and saved for future reference.

1.6 Service Life

The expected service life of this product is three years when used daily and in accordance with the safety instructions, maintenance intervals and correct use, stated in this manual. The effective service life can vary according to frequency and intensity of use.

2 Safety

2.1 Safety Information

Education, clinical judgement and action-based planning based on vulnerability are fundamental factors in prevention of pressure injuries.

A range of assessment scales can be used as a formal method of assessing risk from pressure injury development, and should be used in conjunction with an informal assessment (informed nursing judgement). Informal assessment is considered to be of greater importance and clinical value.

WARNING!
Risk of Serious Injury or Damage
Improper use of this product may cause injury or damage.
- If you are unable to understand the warnings, cautions or instructions, contact a health care professional or provider before attempting to use this equipment.
- Do not use this product or any available optional equipment without first completely reading and understanding these instructions and any additional instructional material such as user manual, service manual or instruction sheet supplied with this product or optional equipment.

WARNING!
Risk of Developing Pressure Injuries
The device delivers effective pressure reduction, when the support surface is covered with a cotton, cotton combination or linen bed sheet, and any one of these is the only item deployed between the support surface and the user.
- Bed sheets must be loosely fitted, with creases smoothed out.
- Ensure that the support surface in contact with the user is kept free from crumbs and other food debris, and that drip cables, stents, and other foreign objects do not become entrapped between the support surface and the user.
- Heated over blankets must only be used in consultation with a qualified healthcare professional, as an increase in temperature can increase the risk of developing pressure injuries.

WARNING!
Risk of fire or explosion!
A cigarette can burn a hole in the bed surface and cause damage to the device. Also, patient clothing, bed sheets, etc. may be combustible and cause a fire. Failure to observe this warning can result in a severe fire, property damage and cause physical injury or death.
- Take special care in oxygen rich environments.
- Do not smoke.

CAUTION!
Risk of Injury
Non-original or wrong parts may affect the function and safety of the product.
- Only use original parts for the product in use.
- Due to regional differences, refer to your local Invacare catalog or website for available options or contact your Invacare distributor. See addresses at the end of this document.

2.2 Safety Information for Transport

Take care when handling the product to ensure no damage to the cover.
It is recommended that two people lift/carry the product.
Avoid contact with jewellery, nails, abrasive surfaces etc.
Do not drag the product.
Avoid contact with wall, door frames, door catches or locks etc.
Do not transport in roll cages unless completely protected from the sharp edges of the cage.

2.3 Symbols on the product

| Medical Device| | European Conformity
---|---|---|---
| Lot Number| | Do not bleach
| Tumble dry low temperature| | Do not iron
| Do not dry clean| | Machine wash max. temperature is shown in symbol.
| Maximum user weight. See 7.1 General Data| | Do not pierce or cut
| Do not put near flame| | Manufacturer
| Date of manufacture| | European representative
| Read user manual| |

3 Product Overview

3.1 Product description

This product is made of foam incorporating geometrically cut sections that operate independently to provide immersion and even weight distribution. These sections also allow air to circulate, which can have a positive effect on microclimate conditions. The water-resistant cover provides a vapour-permeable surface, to ensure patient comfort and maximise the effectiveness of the foam. The cover has a non-slip base specifically designed to inhibit the overlay from slipping once positioned correctly. This product provides the optimum prevention of pressure injuries for those “High Risk” patients.

3.2 Intended use

This product is intended to be used as part of an overall pressure injury prevention program of care. Designed to offer additional comfort and support to sit on top of an existing conventional mattress. It can be used in conjunction with a pressure injury prevention program for “High Risk” patients when the product is in normal use. Normal use is defined by Invacare Ltd as when the product is placed, without additional covers or padding, between the user and the support surface. Replace the cover in case of damage. Do not use with another cover.

3.3 Components

The following components are included within the scope of delivery:

INVACARE Pressure Relieving Mattress Topper 02

A Multi-stretch waterproof polyurethane cover
B Foam insert
C User Manual

4 Usage

4.1 Safety information

WARNING!
Invacare advises that the patient is assessed by a trained health care professional. This is to ensure the correct size and positioning requirements are achieved for the best pressure and postural care and that the individuals needs are met.

WARNING!
It is very important for the patient to reposition themselves, or to be repositioned, on a regular basis. This relieves pressure which helps prevent both tissue compression and potential injury formation. This must be based on the clinical judgement of a qualified healthcare professional.
- Always consult a qualified health care professional before using the product.
- Monitor the patient frequently.

IMPORTANT!
In domestic settings common causes of damage include cigarette burns and the claws of pets that puncture covers, allowing fluid ingress and staining.

IMPORTANT!
- To prevent accidental cover damage, please ensure that sharp objects are not placed on the cover. When using patient transfer aids, care should be taken not to damage the cover. All transfer aids should be checked for sharp edges or burrs before use.

IMPORTANT!
The covers are breathable and water resistant, however with sustained periods of moisture the top layer of the cover may absorb fluids.
- To avoid this, wipe away any liquid as soon as it is identified.

4.2 Preparing the Overlay for Use

CAUTION!
Risk of Injury or Damage to Property
- Before use, check the product for any defect.
- Do not use a defective product.

Remove all packaging before use.
Place the overlay on top of a mattress with the profiled side uppermost.

5 Maintenance

5.1 Inspection

Check overlay (foam and cover) for strike-through (this may include fluid ingress, stains, rips or damage) after the use of each patient and on a minimum monthly basis (depending on which occurs first) by a suitably qualified and competent person.

Check overlays

Unzip the cover completely.
Check for any staining on the interior foam.
Replace any damaged cover or stained foam and dispose of as per local authority procedure.

5.2 Cleaning and Disinfection

General Safety Information

CAUTION!
Risk of Contamination
- Take precautions for yourself and use appropriate protective equipment.

IMPORTANT!
Wrong fluids or methods can harm or damage the product.
- All cleaning agents and disinfectants used must be effective, compatible with one another and must protect the materials they are used to clean.
- Never use corrosive fluids (alkalines, acid etc.) or abrasive cleaning agents. We recommend an ordinary household cleaning agent such as dishwashing liquid, if not specified otherwise in the cleaning instructions.
- Never use a solvent (cellulose thinner, acetone etc.) that changes the structure of the plastic or dissolves the attached labels.
- Always make sure that the product is completely dried before taking it into use again.

For cleaning and disinfection in clinical or long-term care environments, follow your in-house procedures.

Cleaning Intervals

IMPORTANT!
Regular cleaning and disinfection enhances smooth operation, increases the service life and prevents contamination.
Clean and disinfect the product
- regularly while it is in use,
- before and after any service procedure,
- when it has been in contact with any body fluids
-before using it for a new user.

IMPORTANT!
- Keep a cleaning record as part of cleaning the system.

Cleaning Instructions

Cleaning Covers

(Removal of contaminants such as dust and organic matter)

Remove cover for laundering.
Launder the cover with maximum temperature as stated on product label, using a diluted detergent solution (Instructions on label).

IMPORTANT!
Washing at higher temperatures will cause shrinkage.

Drying Covers

Hang cover from a line or bar and drip dry in a clean indoor environment.
or
Tumble dry on a low temperature.

IMPORTANT!
- Tumble dry setting must not exceed 40 °C.
- Do not tumble dry for longer than 10 minutes.
- Dry thoroughly before use.

Disinfection Instructions

Information on recommended disinfectants and methods can be found on https://vahonline.de/en/for-users.

Also look up your country’s recommended disinfectants and methods.

Disinfecting covers

(Reducing the number of microorganisms)

Wipe down the cover with a suitable detergent.
Rinse the cover with clean water using a single-use nonabrasive cloth.
Dry the cover thoroughly.

Heavy soilage
Where the product is badly soiled, we recommend cleaning with a dilute cleaning solution at 95 °C in the washing machine.
- Clean up all spillages of bodily fluids i.e. blood, urine, faeces, sputum, wound exudate and all other bodily secretions as soon as possible using a suitable detergent.
- Large spillages of blood should be absorbed and removed with paper towels first.

5.3 Replacing Cover

Unzip cover and remove it carefully from foam insert.
Place new cover onto foam insert.
Close zipper.

IMPORTANT!
- Ensure that the corners of the foam insert are positioned correctly into the corners of the cover.
- Ensure that the castellated foam is facing upwards when inserted into its cover.

WARNING!
- In event of contamination, contact your hygiene specialist.
- Remove contaminated foams from use.

6 After Use

6.1 Storage

IMPORTANT!
- Store overlays in a dry environment.
- Store overlays within a protective cover.
- Store items on clean, dry surface free from sharp edges to avoid any possible damage.
- Never store other items on top of a overlay.
- Do not store overlays next to radiators or other heating devices.
- Protect overlays from direct sunlight.

Refer to the storage and shipping conditions in section 7.3 Environmental Parameters.

6.2 Disposal

Be environmentally responsible and recycle this product through your recycling facility at its end of life.

Disassemble the product and its components, so the different materials can be separated and recycled individually.

The disposal and recycling of used products and packaging must comply with the laws and regulations for waste handling in each country. Contact your local waste management company for information.

6.3 Reconditioning

This product is suitable for reuse. To recondition the product for a new user, carry out the following actions:

Inspection
Cleaning and disinfection

For detailed information, see 5 Maintenance.

Make sure that the user manual is handed over with the product.

If any damage or malfunction is detected, do not reuse the product.

7 Technical Data

7.1 General Data

Product| Total Height [mm]| Total Width [mm]| Total Length [mm]| Maximum user Weight [kg]| Weight of Product [kg] 1)
---|---|---|---|---|---
Propad Overlay| 85| 560 – 1525| 1830 – 1980| 108| 5.5
Propad Premier Overlay| 85| 876| 1875| 108| 5.5
Propad Visco Overlay| 85| 560 – 1370| 1830 – 1980| 108| 7.1
Propad Renal Overlay| 85| 570| 2180| 108| 5.5

Weights can vary depending on size of overlay ordered, average weights used as an indication.
Local requirements / certification available upon request from Invacare.

7.2 Materials

Foam	Polyurethane foam components
Cover	Polyurethane

All overlay components are Latex-Free.

7.3 Environmental Parameters

| Operating conditions| Storage and shipping conditions
---|---|---
Ambient temperature| 10 – 35 °C| -40 – 70 °C
Relative humidity| 30% – 75% Non-Condensing| 10% – 100%
Atmospheric pressure| 70 – 106 kPa| 50 – 106 kPa

United Kingdom:
Invacare Limited
Pencoed Technology Park, Pencoed
Bridgend CF35 5AQ
Tel: (44) (0) 1656 776 222
Fax: (44) (0) 1656 776 220
uk@invacare.com
www.invacare.co.uk

Portugal:
Invacare Lda
Rua Estrada Velha, 949
P-4465-784 Leça do Balio
Tel: (351) (0)225 193 360
Fax: (351) (0)225 1057 39
portugal@invacare.com
www.invacare.pt

Deutschland:
Invacare GmbH
Am Achener Hof 8
D-88316 Isny
Tel: (49) (0)7562 700 0
kontakt@invacare.com
www.invacare.de

Sverige:
Invacare AB
Fagerstagatan 9
S-163 53 Spånga
Tel: (46) (0)8 761 70 90
Fax: (46) (0)8 761 81 08
sweden@invacare.com
www.invacare.se

España:
Invacare S.A.
Avenida del Oeste, 50 - 1º-1a
Valencia-46001
Tel: (34) 972 493 214
contactsp@invacare.com
www.invacare.es

Invacare UK Operations Limited
Pencoed Technology Park, Pencoed
Bridgend CF35 5AQ
UK

1633776-A 2021-08-18

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