INVACARE IPM1080B39 Softform Premier Bariatric Mattress User Manual

: June 6, 2024
: INVACARE

Table of Contents

General
Safety
Product Overview
Usage
Maintenance
After Use
Technical Data
Documents / Resources

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.

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. Note that there may be sections in this document, which are not relevant to your product since this document applies to all available models (on the date of printing). If not otherwise stated, each section in this document refers to all models of the product. The models and configurations available in your country can be found in the country-specific sales documents. 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. For more information about the product, for example, product safety notices and product recalls, contact your Invacare distributor. See addresses at the end of this document. 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 Give 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
Unauthorized modifications and/or use of unsuitable spare parts

1.6 Service Life
The expected service life of this product is five 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.

Safety

2.1 Safety Information
Education, clinical judgment, and action-based planning based on vulnerability are fundamental factors in the 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 judgment). 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 the 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 severe fire, and 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 mattresses to ensure no damage to the cover.
It is recommended that two people lift/carry mattresses.
Avoid contact with jewelry, nails, abrasive surfaces, etc.
Do not drag mattresses.
Avoid contact with walls, door frames, door catches or locks, etc.
Do not transport in roll cages unless completely protected from the sharp edges of the cage.

Product Overview

3.1 Product Description
The mattress offers exceptional pressure-reducing qualities, specific to the individual’s needs. By promoting even weight distribution, they reduce tissue pressure in potentially
vulnerable areas. The water-resistant cover provides a vapor-permeable, multi- stretch surface, to promote patient comfort and maximize the effectiveness of the foam core.
3.2 Intended Use
This mattress is intended to deliver effective pressure redistribution to users. It is intended to be used in conjunction with an appropriately sized bed frame as part of an overall pressure injury prevention program of care.
Indications
Suitable for users ‘At Risk/ High Risk/ Very High Risk’ of developing pressure injuries.
3.3 Scope of Delivery
The following components are included within the scope of delivery *:

A	The multi-stretch waterproof polyurethane cover
B	Castellated foam insert
C	Single piece foam “U” core
D	Toughed polyurethane coated base
E	User Manual

This example is based on Softform Premier, other mattress configurations may vary.
3.4 Symbols on the Product

| Medical Device| | European conformity
---|---|---|---
| Manufacturer| | Date of
manufacture
| European representative| | Read user manual
| Do not pierce or cut| | Line dry
| Do not dry clean| | Machine wash temperature.
Max. temperature is shown in the symbol.
| User weight limit. See 7 Technical Data, page 6.| | Do not iron
| Do not put near flame| | Tumble dry low heat
| Do not bleach| | LOT number

Usage

4.1 Safety Information
WARNING!
Insufficient repositioning of the patient can lead to tissue compression and potential injury formation. To relieve pressure, it is very important for the patients to reposition themselves, or to be repositioned, on a regular basis.

Before using the product, always consult a qualified healthcare professional for clinical judgment.
Monitor the patient frequently.
CAUTION!
Make sure that the printed side of the mattress cover always faces upwards.
Ensure that the distance between the surface of the mattress and the top of the side rail is at least 220 mm.
CAUTION!
Risk of damage to the mattress
If holes are present in the mattress cover, there is a risk that liquids may ingress and contamination may occur.
Ensure that the mattress is not jammed or damaged by sharp edges.
Do not place hypodermic needles, Evenflo’s, scalpels, or other similarly sharp objects on or under the mattress.
Do not use electrically heated blankets directly on or under the mattress.
Ensure that all Evenflo’s are taped down correctly with no sharp edges exposed.
When using bridging boards or other patient transfer aids, check for any sharp edges or burrs before use.
When using the mattress on a profiling bed ensure that the knee break is used before the backrest.
Attach medical equipment including infusion pumps and monitors to appropriate bed accessories.
Avoid cigarette burns and pet claws puncturing the mattress cover.

4.2 Preparing the Mattress for Use
CAUTION!
Risk of Injury or Damage to Property

Before use, check the product for any defects.
Do not use a defective product.

Remove all packaging before use.
Place the mattress directly on the mattress support of the bed or place the mattress overlay on the existing mattress.
Compress rolled mattresses must be left to recover before use. Follow the instructions on the packaging inlay. Mattresses that are delivered flat packed can be used immediately.

Maintenance

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

Check mattress

Unzip the cover completely.
Check for any staining on the white underside of the cover.
Check for any staining on the interior foam.
Replace any stained items 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.), abrasive cleaning agents, or solvents (cellulose thinner, acetone, etc.). We recommend a mild detergent.
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 enhance smooth operation, increase the service life, and prevent 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 the product label, using a diluted detergent solution (Instructions on the 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 at 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
IMPORTANT!
Only use disinfectants and methods approved by your local infection control institution and follow your local infection control policy.
Follow your local decontamination protocols.

Disinfecting covers
(Reducing the number of microorganisms)
IMPORTANT!
Failure in the disinfection process may result in the accumulation of reagents that could damage the polyurethane coating, react with the bed frame, or negate the biocompatibility results.

Ensure that all cleaning agents, and disinfectants, are thoroughly rinsed off.
Dry thoroughly before use.

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

Heavy spoilage
Where the mattress is badly soiled, we recommend cleaning with a dilute cleaning solution at a maximum temperature in the washing machine (see product label).

Clean up all spillages of bodily fluids i.e. blood, urine, feces, 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.

WARNING!

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

Autoclaving covers
Autoclave the cover at 110° C.
IMPORTANT!

Make sure the cover is outstretched (not folded).
Do not place covers on top of each other.

5.3 Replacing Cover

Unzip the cover and remove it carefully from the 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.

After Use

6.1 Storage
IMPORTANT!

Store mattresses in a dry environment.
Store mattresses within a protective cover.
Store items on the clean, dry (off-floor) surface with no sharp edges to avoid any possible damage.
Never store other items on top of a mattress.
Do not store mattresses next to radiators or other heating devices.
Protect mattresses from direct sunlight.

For environmental conditions for storage, see 7 Technical Data, page 6 .
6.2 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, page 4. Make sure that the user manual is handed over with the product. If any damage or malfunction is detected, do not reuse the product.

6.3 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.

Technical Data

7.1 General Data

Product| Width2| Dimensions [mm]
Length| Height| Maximum user
weight [kg]| Weight of
product [kg]’
---|---|---|---|---|---
Premier| 750— 900| 1830 — 2100| 152| 248.| 14
MaxiGlide| 800 — 900| 1830 — 2100| 152| 248.| 14.
Premier Visco| 750— 900| 1830 — 2100| 152| 248.| 14
Excel| 750 — 900| 1830 — 2100| 152| 140| 10
Premier Original| 850 — 880| 2000| 152| 248.| 14
Bariatric| 1150, 1200, 1370| 2000, 2050, 2100| 152| 340| 15
A&E Trolley| 560 — 700| 1830 — 1930| 100 (TM40)
120 (TM60)| 108 (TM40)
140 (TM60)| 7.0
Spinal| 750 — 900| 1830 — 2100| 152| 248.| 14