INVACARE Eskal L839 Matter Overlay with Pump User Manual

: June 6, 2024
: INVACARE

Table of Contents

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

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
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. We comply with the current environmental legislations WEEE and RoHS.

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 two 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 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.

Product Overview

3.1 Intended Use

The mattress overlay is intended for pressure redistribution and comfort, as part of an overall pressure ulcer prevention program of care.
The mattress overlay is to be used in conjunction with an appropriately sized mattress and bed frame. It delivers effective pressure redistribution, provided a bed sheet(cotton, cotton combination, or linen) is the only item deployed between the support surface and the user.
The product is suitable for use in-home care, residential, nursing and acute care settings.

Indications for Use

Persons with limited ability to shift their weight with the consequent risk of pressure ulcers.

Contraindications

Persons with unstable spinal cord fractures and/or cervical traction.

Invacare presumes medical professionals have made an individual assessment to determine the patient’s risk level or therapy requirements.

3.2 Product Description

The mattress overlay comprises a single air cell layer support surface. It is accompanied by a pump, whose air is 1631420-A.
flow rate is adjustable according to the user’s needs. The system provides gentle and dynamic support.

3.3 Symbols on the Product

****	European Conformity	****	Medical device
Manufacturer	****	Date of manufacture
European representative	****	Type BF applied part
WEEE conform		Class II equipment
****	Serial number		Read user manual

Setup

4.1 Safety Information

WARNING!
Risk of Injury or Damage

This device is recommended to be installed on medical bed frames of an appropriate size with bedsides or assist rails, to accommodate the device. It is preferred that the rails are in the raised position whenever the patient is on the bed. Healthcare professionals assigned to each case should make the final decision whether assist rails are warranted after assessing the patient’s risk of entrapment. Controls on the footbed end may be obstructed by the control unit on a few bed frames. It may be necessary to relocate the control unit.
– Before placing the patient on the bed, check that connector and power cord are clear of moving bed components.
– Operate all motorized bed frame functions through their full range of motion to be certain that there is no pulling, interference, or pinching.
– Take care when positioning connectors and cables to eliminate the risk of tripping hazards or strangulation.

IMPORTANT!
Inappropriate handling can damage the device.
– It is recommended that two people lift/carry the device.
– Avoid contact with jewelry, nails, abrasive surfaces, etc.
– Do not drag the device.
– 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.

4.2 Installing the System

Perform one of the following:
a. Place the Alternating Pressure Pump on a flat surface near the bed.
b. Open the hooks B on the back of the Alternating Pressure Pump A and install them on the outside of the bed frame C.
Place the mattress overlay on the mattress. The air chamber openings should be at the foot end of the bed.
Slide the two end flaps under the mattress at the head and foot end of the bed.
Connect air hoses with fittings F to the air chamber openings D on the mattress overlay E. Check that the hoses are not kinked or caught under the mattress.

Usage

5.1 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!
Risk of damage to the device

If holes are present in the device, there is a risk that liquids may ingress and contamination may occur.
– Ensure that the device 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 device.
– Do not use electrically heated blankets directly on or under the device.
– 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 device 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 device.

5.2 Using the System

Plug the power cord into the outlet.
Turn power switch B to the ON position. The green light will be illuminated when the power is on.
Turn knob A to the maximum setting (clockwise). Wait approx. 15 minutes for the mattress overlay to inflate.

Adjusting the Pump

The pump will cycle every five minutes, inflating and deflating the two air chambers. The pressure of the pump can be adjusted to provide maximum effectiveness and pressure
relief for the patient.

Ensure the patient is lying on the mattress overlay.
Adjust the pressure to the desired setting. Turn the knob clockwise to increase pressure or turn it counter-clockwise to decrease pressure.
Slide the flat portion of your hand between the mattress and the mattress overlay. There should be a cushion of air.

The following table provides approximate pressure settings according to the weight of the patient:

Pressure level	Weight	Pressure level	Weight
1 (MIN)	30 kg	6	80 kg
2	40 kg	7	90 kg
3	50 kg	8	100 kg
4	60 kg	9 (MAX)	110 kg
5	70 kg

Maintenance

6.1 Safety Information

WARNING!
Electrical shock hazard!
– Do not remove the control unit shroud.
– Refer to qualified service personnel.
– Before performing any maintenance to the control unit, disconnect the power lead from the wall outlet.
– Do not insert items into any openings of the control unit. Doing so may cause fire or electric shock by shorting the internal components.

CAUTION!
Risk of Injury or Damage
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.
– Do not modify this equipment without the authorization of the manufacturer.

6.2 Cleaning and Disinfection
General safety information

CAUTION!
Risk of contamination

– Take precautions for yourself and use appropriate protective equipment.

CAUTION!
Risk of electric shock and product damage
– Switch off the device and disconnect from mains, if applicable.
– When cleaning electronic components consider their protection class regarding water ingress.
– Make sure that no water splashes the plug or the wall outlet.
– Do not touch the power socket with wet hands.

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 enhance smooth operation, increase 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

IMPORTANT!

– The product does not tolerate cleaning in automatic washing plants, with high-pressure cleaning equipment or steam.
A cleaning record should be kept as part of cleaning the system.
Cleaning Alternating Pressure Pump
1. Wipe down the control unit casing and hose fittings with a damp cloth and suitable detergent.
2. Using a nylon brush, gently clean all crevices as they can harbor microorganisms.
3. Wipe off the control unit casing and hose fittings with a damp cloth to remove all detergent.
4. Air dry all treated surfaces. Cleaning Mattress Overlay
1. Wipe down the mattress with a damp cloth and suitable detergent.
2. Using a nylon brush, gently clean all crevices as they can harbor microorganisms.

Disinfection Instructions

IMPORTANT!
– Only use disinfectants and methods approved by your local infection control institution and follow your local infection control policy.
– Additional information on recommended disinfectants can be found at <https ://vah-online.de/en/for-users>.

Wipe down all generally accessible surfaces with a cloth and appropriate disinfectant.
Allow the product to air-dry.

After Use

7.1 Storage

IMPORTANT!
– Store the device in a dry environment.
– Store the device within a protective cover.
– Carefully roll up the device and store it on a clean, dry (off-floor) surface with no sharp edges to prevent possible damage.
– Never store other items on top of a device.
– Do not store devices next to radiators or other heating devices.
– Protect the device from direct sunlight.
For environmental conditions for storage, see “Environmental conditions”.

7.2 Reconditioning

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

Inspection according to the service plan
Cleaning and disinfection

For detailed information about inspection, cleaning and disinfection, refer to 6 Maintenance, page 4.

7.3 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

8.1 General Specifications

Electrical cable length	3 m
Airflow	4.5 l/min.
Complete cycle duration	12 min.
Fuse	1 A; 250 V
Max. user weight	110 kg
Mattress overlay size	200 cm x 88 cm

8.2 Environmental Conditions

| Operation| Storage and Transport
---|---|---
Ambient temperature| 10 °C – 40 °C| -10 °C – 60 °C
Relative humidity| 30% – 75%,
non-condensing| 10% – 70%, non-condensing
Atmospheric pressure| 70 – 106 kPa| 50 – 106 kPa

1631420-A 2021-05-03

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