EFECTA, PREMA, CLINICARE and ERGOMAT Operation Instructions and Technical Description April 2011

Passive antidecubitus mattresses Linet Author: LINET, s.r.o. Jakub Hemr ([email protected]) Related links: www.linet.cz Version: 05 Print date: 09/2010 File name: NAVOD_PASIVNI_MATRACE_10-2010_05_GBL.doc Copyright © LINET, s.r.o., 2010 Translation © LINET, 2010 All rights reserved. All trademarks and brands are the property of the appropriate owners. The manufacturer reserves the right to changes in the contents of this manual that relate to the product’s technical regulations. It is for this reason that the contents of this manual may indicate differences from the current manufacture of the product.

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Dear Customer, Thank you that you have decided to buy a product of our company and we believe that you will be satisfied with it throughout the whole period of its use. Thanks to careful selection of materials, up-to-date technologies and careful work of our employees our products achieve parameters that guarantee high quality, reliability and permanent utility value.

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Content 1

Introduction ...5

2

Safety ...5

2.1

3 3.1 3.2 3.3 3.4 3.5

4

Safety instructions for the use of mattresses ...5

Description and use of the mattresses ...7 EFECTA ...7 PREMA...7 CLINICARE ...8 ERGOMATT ...8 Rotating and turning of the mattress...9

Table – Mattresses characteristics ...10

4.1 Mattresses recommended for general wards ...10 4.2 Mattresses recommended for general wards and also wards with permanent load of the mattress 11

5 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.2

Maintenance of the covers and mattresses...12 The LINTEX cover and waterproof cover used on Efecta mattresses...12 General...12 Cleaning ...12 Disinfection...12 Washing ...12 Drying ...12 Ironing ...12 Mattress core ...13

6

Storing ...13

7

Environmental protection ...13

8

Guarantee and servicing...15

9 No

Contact...15

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1

Introduction

These instructions are written for medical staff taking care of the patient laying on the bed. Passive mattresses are designed by the manufacturer to be used as support for patients hospitalized on hospital beds. The particular use of each type of mattress depends on the condition and diagnosis of the patient, mainly with respect to the risk of developing pressure ulcers or the degree of decubitus already formed. This method of use is mentioned in the chapter “Description and use of the mattresses”, see page 7. Before you start using the mattress, you must read these instructions thoroughly. All procedures must be performed in compliance with these instructions, any other use is performed at the user’s own risk and the manufacturer is not liable for any resulting damage! It is important to keep the instructions throughout the life of the product, until the mattress is disposed of!

2

Safety

This product's characteristics comply with the technical parameters related to it and stated in MDD 93/42/EEC, which stipulates the technical parameters for healthcare products. The said product fulfils the requirements of the harmonized technical standard - EN ISO 10993. The producer proceeds in conformity with certified quality management system according to DIN EN ISO 9001:2000, EN ISO 13485:2003, ISO 14001:2004 standards determining stricter conditions for medical equipment manufacturers. The mattress may be used in the environment where:
The temperature range is + 10°C to + 40°C
The relative humidity range is 30% to 75%
The range of atmospheric pressure is 700 hPa to 1060 hPa

2.1

Safety instructions for the use of mattresses

Before the use of the mattress you must get familiarized with its “Description and use”. Before positioning the patient the user must verify the condition of the mattress. The mattress must not be used if failures have been found that can do harm to the patient or mattress. The selection of the kind and application of the mattress must always be consulted with the physician, especially in the case of an injury of the head, spinal cord and backbone.
A patient with the indication of a higher risk of decubitus formation than that the mattress is designed for must not be positioned on the mattress.
AD mattresses are designed for the prevention and treatment of decubitus of the patient and this is why it is necessary to monitor the condition of the patient and his/her skin continuously and to change his/her position to prevent stressing risk and affected parts of his/her body.
The mattress must not be laid on the patient surface if there is a danger that the mattress could be disturbed or the overlay torn with sharp parts of the bed or other sharp objects.

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In the case of long-term use you should monitor the condition of the core whether it is not permanently pressed, which could reduce the anti-decubitus properties of the product.
If the mattress is covered unsuitably (with polythene or rubber pad on top of it) the anti-decubitus properties of the product are suppressed.
Action of light can change the color tone of the mattress core. This change has no effect on physical properties of the mattress core.
Mattress can have characteristic smell, which disappears in time. The material used is evaluated by the head hygienist of Czech Republic for its biocompatibility even for children less than 3 years of age. It is forbidden to put the bed with mattress into Trendelenburg (Antitrendelenburg) position, when the bed-ends are removed. It can cause the mattress ride down from bed in direction of declination. The mattress Duotera is two – sided. It is recommended to turn them (exchange the upside and backside of mattress) to elongate their lifespan. The orientation of cover must be preserved – only core should be turned. The turning interval is a minimum of once a month. It is necessary to rotate all the mattresses to increase their lifespan. The turning interval is a minimum of once a month. This is preventive measure against permanent deformation of the core. The mattress must be placed on suitable type of mattress platform according to the size of gaps, which should not exceed 4 cm. In the case of mattress platform without any holes it is necessary to regularly ventilate the mattress. This is preventive measure against the damage of the core due to moisture inside.

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3

Description and use of the mattresses

3.1

EFECTA

Standard mattress designed for use in nursing and home care and healthcare. It is proposed for patients with very low risk of pressure sores. The core of mattress is made from high resilient polyurethane foam. Cover is made from washable, water resistant fabric. This fabric is vapor permeable and bidirectional elastic.

ROTATING AND TURNING OF THE MATTRESS The mattresses must be regularly rotated (exchange head and foot end). The rotating interval is a minimum of once a month. The mattress EFECTA is only one sided, it must be placed properly with the contoured surface upwards. This is preventive measure against permanent deformation of the core.

3.2

PREMA

A preventive anti-decubitus mattress made of quality cold PU foam with the Lintex cover. The core of mattress is cut through in the longitudinal and transversal direction. The core is reinforced with edges made from rigid foam. The mattress is suitable for patients with a low risk of decubitus formation. Norton Scale 20-17.

ROTATING AND TURNING OF THE MATTRESS The mattresses must be regularly rotated. The rotating interval is a minimum of once a month. The mattress PREMA is only one sided, it must be placed properly with the profiled part upwards. This is preventive measure against permanent deformation of the core.

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3.3

CLINICARE

A preventive anti-decubitus mattress of cold foam with the Lintex cover. The mattress is made up of three zones: head, body, heels. The zone under the head and heels is composed of three kinds of foam with a different density, hardness and profile. The centre of the mattress is filled with foam with a big distributing capability. Along the perimeter the mattress is reinforced with hard foam. The mattress is suitable for patients endangered with a high risk of decubitus formation and for patients with existing decubitus of 2nd degree (Stirling). (The viscoelastic foam used on Clinicare mattress is characterized by the shape memory – it reacts to pressure release slowly than common foams).).

3.4

ERGOMATT

A preventive anti-decubitus mattress made of cold PU foam, equipped with the Lintex HF welded cover. The core is a block of thick foam which is covered by a layer of visco. The mattress can be recommended for patients with a medium degree of risk and patients with existing damages of tissues of the 1st degree – Stirling. Norton 20-17.).

ROTATING AND TURNING OF THE MATTRESS The mattresses must be regularly rotated. The rotating interval is a minimum of once a month. The mattress CLINICARE, ZONECARE, ERGOMATT are only one sided, they must be placed properly ¨¨ with the viscoelastic foam layer(CLINICARE), with the 5 ZONE (ZONECARE) upwards. See the picture This is preventive measure against permanent deformation of the core.

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3.5

Rotating and turning of the mattress

ROTATING This means changing the head end foot end of the mattress TURNING This means changing the top and bottom part of the mattress The orientation of cover must be preserved – only core should be turned.

EFECTA PREMA ZONECARE

EFECTA VISCO CLINICARE ERGOMATT

Rotating

Yes

Turning

No

Table No.1 -

Rotating and turning of the mattress

Picture No.1 - Rotating and turning of the mattress OTHER WARNINGS When selecting the mattress you must take into account the dimensions of the patient surface of the bed the mattress is to be used for. For this reason are the mattresses offered in these basic dimensions: 200 x 86 cm and 208 x 86 cm. In addition, the mattress PREMA is offered in dimension 200 x 90 cm. The exception is Ergomatt which is designed specifically for Ergoframe platform – its dimmensions are 208 x 96 x 14 cm. A patient with the indication of a higher risk of decubitus formation than that the mattress is designed for must not be positioned on the mattress.

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4

Table – Mattresses characteristics

4.1

Mattresses recommended for general wards EFECTA

PREMA

Very low I

Medium II

Norton

20-19

20-17

Decubitus stage (Stirling) 1

None

None

Type

Standard mattress

Preventive antidecubitus

Material

PU foam

PU foam

Cover

Waterproof cover

Lintex Porotex, welded

Load limit (This value is just for information)

up to 100 kg

up to 110 kg

Weight of the mattress

7,5 kg

8,2 kg

Height

14 cm

14 cm

Recommended way of use 2 S Standard / Intensive

Standard

Intensive

Risk of decubitus formation depending on patient’s condition

1

Reid J., Morrison M. (1994): Towards a konsensus: classification of pressure sores. Journal of Wound Care 3 (3) 157-160 2 Standard – general wards, Intensiv – permanent load (24 h./day )purpose mattress

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4.2

Mattresses recommended for general wards and also wards with permanent load of the mattress CLINICARE

ERGOMATT

High III

Medium II

20-13

20-17

nd

up to 2 stage

up to 2 stage

Damaged epidermis

Damaged epidermis

1,6

3,1

Preventive combined antidecubitus

Preventive antidecubitus

PU and visco foams

PU foam, visco

Welded cover

Lintex Porotex

Lintex Porotex

Load limit (This value is just for information)

up to 120 kg

up to 120 kg

Weight

8.6 kg

12,5 kg

Height

14 cm

14 cm

Recommended way of use 5 Standard / Intensive

Intensive

Intensive

Risk Norton Decubitus stage (Stirling)

3

stage of decubitus CPP

4

Mattress type Material

nd

3

Reid J., Morrison M. (1994): Towards a consensus: classification of pressure sores. Journal of Wound Care 3 (3) 157-160 4 CPP is a coefficient specifying the use of the mattress depending on the risk of decubitus formation and decubitus degree. The CPP coefficient expresses the area of the mattress in % where the pressure values exceed 32 mmHg. 5 Standard – general wards, Intensive – permanent load (24 h./day )purpose mattress

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5

Maintenance of the covers and mattresses

5.1

The LINTEX cover and waterproof cover used on Efecta mattresses

5.1.1

General The result of some cleaning procedures is the occurrence of minor folding of the surface. This fact has no impact on the entire properties of the product. Do not use agents containing aldehydes or phenols for cleaning, disinfection and washing! Maximal allowed concentration of Cl based disinfectants is (Chloramine) is 0,5 % After the disinfection procedure it is necessary to wash the surface of the cover with clean water and dry it thoroughly.

5.1.2 Cleaning Superficial dirt can be removed with a fine cloth moistened in water containing a cleaning agent. Stubborn staining can be removed with alcohol (methyl, spirit) and afterwards with hot water and a neutral cleaning agent. 5.1.3 Disinfection The overlay can be disinfected with normal disinfection agents in concentration prescribed for medical facilities (e.g. chloroxylenol 4,9g/100g water or 2-propanol 50ml/m3). These disinfection agents may only be used in compliance with the instructions of the manufacturer. After disinfecting you must always rinse the surface with clean water and dry thoroughly. 5.1.4 Washing Non-colored covers can be washed at the temperature up to 90°C, colored up to 70°C with the use of nor mal cleaning agents. We do not recommend you to use abrasive agents (powders, etc.) or softening agents. 5.1.5 Drying After all cleaning and washing procedures and before storing the cover must be dried thoroughly. You can dry the cover by hanging it, twisting or squeezing at temperatures up to 30 °C. The Lintex cannot be mangled! 5.1.6

Ironing It is forbidden to iron the Lintex cover.

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5.2

Mattress core

The entire core of the mattress does not require any major cleaning. The core does not need disinfection. After a longer use it is suitable to ventilate the mattress. If the core is soiled heavily, you can use central sterilization procedures (steam sterilization). The parameters of the steam sterilization procedure must be provided in accordance to instructions of the producer of steam sterilization device. It is forbidden to wash the mattress core with water!

6

Storing

Store the mattress in dry and cool spaces. When storing the mattress, do not bend it. Avoid excessive pressure and contact with non-colorfast materials..

7

Environmental protection

The company LINET, spol. s r.o. is aware of the necessity to protect the environment for future generations and therefore devotes great attention to the development, innovation – planning, production and use of such technology and materials that are environmentally friendly. This product is constructed from materials that are environmentally friendly! The product does not contain dangerous substances based on cadmium, mercury, asbestos, PCB or CFC! The operational noise-level of the product meets the requirements for the protection of public health against undesirable noise and vibration in protected indoor building premises. Wooden parts used in the product are not made from exotic wood such as mahogany, jacaranda, ebony, teak, grenadil or santo, and do not come from the Amazonian rainforests or other virgin forests. All waste packaging left over from when the product is made operational is marked in accordance with the legal regulations on packaging. Sort the waste packaging, which is left over once the product is made operational by following the graphic symbols and deliver it to a person authorized to further utilize it. The product contains recyclable steel, plastic and electronic components – to optimize recycling once the operation of the product ends, separate the individual parts so that the raw materials from which the product is made can be put to further use (see CHART).

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This product is not designed for removal as part of communal waste!

Fines may be imposed under national regulations if an incorrect procedure for waste removal is used. . Protect your health and the environment. Thank you.

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8

Guarantee and servicing

Unless otherwise specified in the contract, 24 months’ guarantee is provided for the mattress starting from the day it is delivered to the user! The guarantee only covers failures or damages of the product resulting from poor quality of used materials, production and assembly. The guarantee does not cover failures of the product resulting from the use of the product in contradiction with the operation instructions or a failure resulting from an unusual use of the product. Guarantee and after-guarantee repairs are performed by the manufacturer or authorized dealer on the basis of a written certificate proving the capability of performing these activities. The certificate is issued by the manufacturer.

9

Contact

Address your questions to: Sales department: Service department:

Address:

Tel.: Tel.: Fax:

+420 312 576 111 +420 312 576 259 +420 312 522 668

LINET spol. s r. o., Želevčice 5, 274 01, Slaný, ČR http://www.linet.cz, e-mail: [email protected]

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