LINET EffectaCare 20 User manual

Instructions for Use and Technical
Description
Passive Mattresses
E󰀨ectaCare 20
E󰀨ectaCare 20 B
E󰀨ectaCare 20 P
PrimaCare 10
PrimaCare 20
PrimaCare 20 B
CliniCare 10
CliniCare 10 P
CliniCare 20
CliniCare 30
D9U004PPM-0101
Version: 01
Publication Date: 2021-04

D9U004PPM-0101_01
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Manufacturer:
LINET spol. s r.o.
Želevčice 5
274 01 Slaný
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
http://www.linet.com
Service department: [email protected]
Passive Mattresses
E󰀨ectaCare 20
E󰀨ectaCare 20 B
E󰀨ectaCare 20 P
PrimaCare 10
PrimaCare 20
PrimaCare 20 B
CliniCare 10
CliniCare 10 P
CliniCare 20
CliniCare 30
Author: LINET, s.r.o.
Related links: www.linet.com
D9U004PPM-0101
Version: 01
Publication Date: 2021-04
Copyright © LINET, s.r.o., 2021
Translation © LINET, 2021
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 the instructions for use that relate to the product´s technical regulations. It is for this reason that the contents of the in-
structions for use may indicate di󰀨erences from the current manufacture of the product. Reproduction, also excerpts, only with prior
permission of the publisher. Subject to changes due to technical developments. All technical data are rated data and are subject to
construction and manufacturing tolerances.

D9U004PPM-0101_01
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1 Symbols and Denitions .............................................................................................................................................................4
1.1 Warning Notices............................................................................................................................................................................4
1.1.1 Types of Warning Notices ..........................................................................................................................................................4
1.1.2 Structure of Warning Notices .....................................................................................................................................................4
1.2 Instructions....................................................................................................................................................................................4
1.3 Lists...............................................................................................................................................................................................4
1.4 Symbols on the Package ..............................................................................................................................................................4
1.5 Symbols and Labels on mattress..................................................................................................................................................5
1.6 Serial Labels .................................................................................................................................................................................7
1.6.1 Mattress Serial Label .................................................................................................................................................................7
1.6.2 Mattress Wash Label .................................................................................................................................................................10
1.7 Abbreviations ................................................................................................................................................................................10
1.8 Denitions .....................................................................................................................................................................................10
2 Safety Instructions.....................................................................................................................................................................11
2.1 Safety Instructions ........................................................................................................................................................................12
3 Intended use...............................................................................................................................................................................13
3.1 User population.............................................................................................................................................................................13
3.2 Contraindications ..........................................................................................................................................................................13
3.3 Operator........................................................................................................................................................................................13
4 Re-use .........................................................................................................................................................................................13
5 Description of Mattresses .........................................................................................................................................................14
5.1 Correct Mattress Orientation.........................................................................................................................................................15
5.2 Transport Handles.........................................................................................................................................................................17
6 Technical Specication ............................................................................................................................................................18
7 Use and Storage Conditions.....................................................................................................................................................19
8 Scope of Delivery and Product Variants..................................................................................................................................20
8.1 Delivery .........................................................................................................................................................................................20
8.2 Scope of Delivery..........................................................................................................................................................................20
8.3 Variants .........................................................................................................................................................................................20
9 Using the Mattress.....................................................................................................................................................................21
9.1 Preparing the mattress for use......................................................................................................................................................21
9.2 Rotating the mattress....................................................................................................................................................................21
10 Accessories and Replacement Components ........................................................................................................................22
11 Cleaning and Maintenance......................................................................................................................................................23
11.1 General Cleaning ........................................................................................................................................................................23
11.2 Mattress Inspection .....................................................................................................................................................................23
12 Disposal ....................................................................................................................................................................................24
12.1 Environment Protection...............................................................................................................................................................24
12.2 Disposal ......................................................................................................................................................................................24
12.2.1 Within Europe ..........................................................................................................................................................................24
12.2.2 Outside Europe ........................................................................................................................................................................24
13 Warranty....................................................................................................................................................................................25
14 Standards and Regulations ....................................................................................................................................................25
Table of Contents

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1 Symbols and Denitions
1.1 1.1 Warning NoticesWarning Notices
1.1.1 1.1.1 Types of Warning NoticesTypes of Warning Notices
Warning notices are di󰀨erentiated by the type of danger using the following key words:Warning notices are di󰀨erentiated by the type of danger using the following key words:
► ► CAUTION CAUTION warns about the risk of material damage.warns about the risk of material damage.
► ► WARNINGWARNING warns about the risk of physical injury. warns about the risk of physical injury.
► ► DANGERDANGER warns about the risk of fatal injury. warns about the risk of fatal injury.
1.1.2 1.1.2 Structure of Warning NoticesStructure of Warning Notices
SIGNAL WORDS!SIGNAL WORDS!
Type and source of danger!Type and source of danger!
► Measures to avoid the danger.► Measures to avoid the danger.
1.2 1.2 InstructionsInstructions
Structure of instructions:Structure of instructions:
► Perform this step.► Perform this step.
Results, if necessary.Results, if necessary.
1.3 1.3 ListsLists
Structure of bulleted lists:Structure of bulleted lists:
■ ■ List level 1 List level 1
□□ List level 2 List level 2
● ● List level 3 List level 3
1.4 Symbols on the Package
KEEP DRY (PROTECT FROM HUMIDITY)
LOW DENSITY POLYETHYLENE RECYCLING SYMBOL
RECYCLING SYMBOL

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1.5 Symbols and Labels on mattress
READ INSTRUCTIONS FOR USE
DO NOT IRON
DO NOT USE A CLEANER CONTAINING PHENOL
DO NOT WRING!
REGULARLY INSPECT THE INSIDE OF THE COVER FOR CONTAMINATION
MACHINE WASH AT 71°C WITH DETERGENT
TUMBLE DRY ON LOW HEAT SETTING (MAX. 60°C)
RINSE WITH WARM WATER AND NEUTRAL DETERGENT (INITIAL TEMPERATURE OF
HOT WATER SHOULD NOT EXCEED 50°C)
DISINFECT USING SOLUTION NO GREATER THAN 1,000PPM OF CHLORINE (SEE
CHAPTER ‘CLEANING AND MAINTENANCE’)
RINSE WITH WARM WATER

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MATTRESS CONFORMS TO BS7177:2008 FOR MEDIUM HAZARD
CE MARK OF CONFORMITY WITH EU REGULATION
SYMBOL FOR TURNING AND ROTATING THE MATTRESS (SEE CHAPTER ‘USING
THE MATTRESS’)
DO NOT BLEACH
PROFESSIONAL CHEMICAL CLEANING (MODERATE PROCEDURE)
MANUFACTURER
MEDICAL DEVICE (compatible with Medical Device Regulation)
GENERAL WARNING SIGN
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00005
230
4PPJ21100AS
200x86x14 cm
CliniCare 30

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1.6 Serial Labels
Pictures of serial labels below serve just for explanation of the signs and elds on the serial labels.
1.6.1 Mattress Serial Label
1Mattress name (one name for di󰀨erent congurations)
2Reference number depending on conguration
3Mattress dimensions depending on conguration
4Maximum Load
Fig. Description of Mattress Serial Label
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00005
230
4PPJ21100AS
200x86x14 cm
CliniCare 30 1
2
4
3

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Fig. Mattress Serial Label
for EectaCare 20
Fig. Mattress Serial Label
for EectaCare 20 B
(Bariatric)
Fig. Mattress Serial Label
for EectaCare 20 P (Pae-
diatric)
EffectaCare 20
4PPB21100AS
200x86x14 cm
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00002
150 300
4PPEB1100AS
200x100x16 cm
PrimaCare 20 B
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00003
EffectaCare 20 P
4PPLI1100AS
137x70x10 cm
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00002
72
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00001
200
4PPD21100AS
200x86x14 cm
PrimaCare 10
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00003
200
4PPE21100AS
200x86x14 cm
PrimaCare 20
300
4PPEB1100AS
200x100x16 cm
PrimaCare 20 B
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00003
Fig. Mattress Serial Label
for PrimaCare 10
Fig. Mattress Serial Label
for PrimaCare 20
Fig. Mattress Serial Label
for PrimaCare 20 B (Ba-
riatric)

D9U004PPM-0101_01
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fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00004
200
4PPG21100AS
200x86x14 cm
CliniCare 10
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00005
230
4PPJ21100AS
200x86x14 cm
CliniCare 30
72
4PPKI1100AS
137x70x10 cm
CliniCare 10 P
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00004
fire reaction class: 1 IM
details of the approval:
EUCZ3200D20D1IM00006
230
4PPH21100AS
200x86x14 cm
CliniCare 20
Fig. Mattress Serial Label
for CliniCare 30
Fig. Mattress Serial Label
for CliniCare 10
Fig. Mattress Serial Label
for CliniCare 10 P (Pae-
diatric)
Fig. Mattress Serial Label
for CliniCare 20

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1.6.2 Mattress Wash Label
LINET spol. s r.o., Želevčice 5, 274 01 Slaný
Made in Czech Republic | www.linet.cz
1.7 Abbreviations
BBariatric (mattress)
CE European Conformity
CMHR Combustion Modied High Resilience
CPR Cardiopulmonary Resuscitation
ICU Intensive Care Unit
IP Ingress Protection
IV Intravenous
MD Medical Device
ME Medical Electrical (Equipment)
PPaediatric (mattress)
PCM Phase Change Material
ppm parts per million, millionth (1000 ppm = 0,1%)
REF Reference Number (product type depending on conguration)
SN Serial Number
SWL Safe Working Load
PU Polyurethane
LDPE Low Density Polyethylene
1.8 Denitions
Maximum Patient Weight on the
bed with mattress
Maximum Patient Weight depends on the application environment according to IEC 60601-
2-52. For application environment 1 (intensive/critical care) and 2 (acute care) reduce Safe
working Load by 65 kg. For application environment 3 (long-term care) and 5 (ambulatory
care) reduce Safe working Load by 35 kg.
Maximum Load The highest allowable load on the mattress.
Adult Patient having a physical size equal to or more than 146 cm, a mass equal to or more than
40 kg and a body mass index (BMI) equal to or more than 17 (according to IEC 60601-2-
52).
Child Patient having a physical size equal to or less than 155 cm and a mass equal
to or less than 70 kg.

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2 Safety Instructions
WARNING!
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established!
WARNING!
This medical device is not intended for oxygen enriched environment!
WARNING!
This medical device is not intended for use with ammable substances!
WARNING!
This medical device is not portable medical electrical equipment!
WARNING!
Limited patient handling leads to development of pressure injury!
WARNING!
Before placing a patient on mattress, always have a suitably clinically qualied person perform a risk assess-
ment to ensure that the support provided is appropriate and fulls the local stipulations!
WARNING!
Support surface selection should be based on documented clinical reasoning, taking into consideration fac-
tors of the individual patient, e.g. mobility, heat, moisture, comfort etc.
WARNING!
High specication support surfaces are designed to complement, rather than replace, best practice in nursing
care, e.g. regular patient turning.
WARNING!
Only nursing personnel trained according to the instructions for use is authorised to perform the installation
of the mattresses on a compatible mattress support platform.
WARNING!
Do not use these products or any additional equipment without reading and understanding these instructions
for use and any other instruction provided!
WARNING!
These instructions for use MUST be given to the user of the product BEFORE using this product. Please read
these instructions for use and save for future reference.

D9U004PPM-0101_01
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2.1 Safety Instructions
► It is necessary to read the instructions for use before using the mattress and perform maintenance according to the in-
structions for use.
► Follow the instructions carefully.
► Do not use a damaged mattress.
► If possible, check the mattress daily or between changing patients.
► Before positioning the patient the user must verify the condition of the mattress.
► Single sided mattresses are only to be used with the screen printing uppermost, and, if necessary, to check the mattress
core has the proling uppermost.
► The mattress must not be used if failures have been found that can do harm to the patient or mattress.
► The selection of the correct mattress type and application of the mattress must always be consulted with qualied clinical
professional, especially in the case of an injury of the head, spinal cord or backbone.
► A patient with the indication of a higher risk of pressure ulcers than the mattress is designed for must not be placed on the
mattress.
► It is necessary to monitor the condition of the patient and his/hers skin continuously and to change his/hers position on the
mattress to prevent stressing risk and a󰀨ected parts of his/hers body.
► The mattress must not be laid on the mattress platform if there is a danger the mattress could be disturbed or the cover
torn with sharp parts of the bed or other sharp objects.
► During using of the mattress it is necessary to monitor the condition of the mattress core to ensure that it is not permanent-
ly compressed which will reduce the anti-decubitus properties of the product.
► Prolonged exposure of light can change the color tone of the mattress core. This change has no e󰀨ect on physical proper-
ties of the mattress core. Polyurethane foams can have di󰀨erent colours. This has no e󰀨ect on physical properties of the mattress
core.
► The mattress cover may shrink slightly or its colour may fade.The mattress is still suitable for use provided the cover does
not become a very tight t (i.e can still bend under gentle pressure) and shows no signs of damage to the top coating.
► The mattress is equipped with PU cover and must not be covered with an additional waterproof sheet as this will stop its
moisture vapour permability function of mattress cover.
► Do not put the bed into Trendelenburg or Anti-Trendelenburg position, when the head board and/or foot board are remo-
ved unless the bed frame is tted with a retaining method to prevent the mattress from sliding up/down the bed when it is at such
angles.
► The mattress must be placed on suitable type of mattress support platform according to the size of gaps between parts of
mattress platform, which should not exceed 4 cm.
► The mattress must respect safety siderail height of a compatible medical bed.
► If the mattress platform has not features to provide ventilation to the base of the mattress, then the mattress should be re-
gularly lifted and the base allowed to dry/breath before further use. This will prevent moisture damage to the base cover and extend
the life of the mattress.
► Continually loaded mattress has shorter lifetime period.

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3 Intended use
The intended use of the E󰀨ectaCare 20, E󰀨ectaCare 20 B, E󰀨ectaCare 20 P, PrimaCare 10, PrimaCare 20, PrimaCare 20 B,
CliniCare 10, CliniCare 10 P, CliniCare 20 and CliniCare 30 mattresses is to assist in the prevention of pressure ulcers.
E󰀨ectaCare 20, E󰀨ectaCare 20 B and E󰀨ectaCare 20 P mattresses are intended for no more than medium risk of pressure
ulcers creation.
PrimaCare 10, PrimaCare 20 and PrimaCare 20 B mattresses are intended for no more than high risk of pressure ulcers
creation.
CliniCare 10, CliniCare 10 P, CliniCare 20 and CliniCare 30 mattresses are intended for no more than very high risk of pre-
ssure ulcers creation.
3.1 User population
► (Standard - no code) - Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17)
► (Paediatric - code P) - Paediatric patients from age of 3 years (10 kg <= patient weight =< 75kg)
► (Bariatric - code B) - Bariatric patients (patient weight =< 250kg)
► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)
3.2 Contraindications
Patient with higher risk of pressure ulcers than the mattress is designed for:
► patients with higher weight than mattress weight limit
► patient’s showing signs of pressure related tissue damage should be transferred onto an alternative support surface based
on risk assessment, clinical reasoning and best clinical practice (EPUAP, NPUAP guidelines)
► Limited patient handling leads to development of pressure injury!
3.3 Operator
► Caregiver
4 Re-use
This product is suitable for repeated use. Before repeated use, ensure that the product is cleaned as per the cleaning and care
instructions in these instructions for use.

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Mattress Feature
Mattress Type
PrimaCare 20 PrimaCare 20
B (Bariatric) CliniCare 10 CliniCare 10 P (Paediatric) CliniCare 20 CliniCare 30
High resilience foam base      
Supporting side walls   
High resilient foam topper  
Visco-elastic (memory
foam) topper    
PCM top layer 
Machine-hinged proling      
Single sided      
Rotate only design      
Welded cover seams      
180⁰ degree zip      
Maximum Load 200kg 300kg 200kg 72kg 230kg 230kg
Mattress Feature
Mattress Type
E󰀨ectaCare 20 E󰀨ectaCare 20 B
(Bariatric)
E󰀨ectaCare 20 P
(Paediatric) PrimaCare 10
High resilience foam base    
Supporting side walls
High resilient foam topper
Visco-elastic (memory
foam) topper
PCM top layer
Machine-hinged proling    
Single sided    
Rotate only design    
Welded cover seams    
180⁰ degree zip    
Maximum Load 150kg 300kg 72kg 200kg
These mattresses are designed to be used in conjunction with a suitably sized mattress support platform, and as part of a pressure
ulcer prevention care programme. These mattresses are not designed for any other use and any such use would void the manu-
facturer’s warranty. These mattresses have been designed to deliver e󰀨ective pressure re-distribution when used in accordance
with the instructions in the instructions for use.
5 Description of Mattresses

D9U004PPM-0101_01
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Fig. PrimaCare 10 (side view)
Fig. EectaCare 20 P (side view)
UPPER SIDE
UPPER SIDE
BOTTOM SIDE
BOTTOM SIDE
Fig. EectaCare 20 (side view)
Fig. EectaCare 20 B (side view)
UPPER SIDE
UPPER SIDE
BOTTOM SIDE
BOTTOM SIDE
5.1 Correct Mattress Orientation

D9U004PPM-0101_01
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Fig. CliniCare 10 (side view)
Fig. CliniCare 20 (side view)
Fig. CliniCare 10 P (side view)
UPPER SIDE
UPPER SIDE
UPPER SIDE
BOTTOM SIDE
BOTTOM SIDE
BOTTOM SIDE
Fig. PrimaCare 20 (side view)
Fig. PrimaCare 20 B (side view)
UPPER SIDE
UPPER SIDE
BOTTOM SIDE
BOTTOM SIDE

D9U004PPM-0101_01
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5.2 Transport Handles
WARNING!
Material damage and risk of injury due to incorrect use!
► Transport the mattress using transport handles without patient on it!
Transport handles are intended for transport of the PrimaCare 20, PrimaCare 20 B, CliniCare 10, CliniCare 10 P, CliniCare 20 and
CliniCare 30 mattresses.
Fig. Transport Handles on the Cover
Fig. CliniCare 30 (side view)
UPPER SIDE
BOTTOM SIDE

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6 Technical Specication
WARNING!
If these mattresses are used with any compatible medical bed, respect values of mechanical specications
which can harm neither mattress nor medical bed!
PrimaCare Range
PrimaCare 10 PrimaCare 20 PrimaCare 20 B (Bariatric)
Mattress type Preventive anti-decubitus Preventive anti-decubitus Preventive anti-decubitus
Material of foam Polyurethane foam Polyurethane foam Polyurethane foam
Material of cover
Backing
Coating
100% polyester
100% polyurethane
Cover Water resistant and vapour permeable
See Cleaning and Maintenance for additional information
Weight of mattress 10kg 11kg 14kg
Height of mattress 14cm 14cm 16cm
Risk of pressure ulcers
creation
High risk* High risk* High risk*
Warranty 2 years** 2 years** 2 years**
Stacking limit 15 pieces 15 pieces 15 pieces
*Indication of use based upon interface pressure readings – not a prescriptive criteria. Always refer to a clinician’s judgement.
**In accordance with an appropriate turning and repositioning regime and with the proper usage and cleaning instructions (see
Cleaning and Maintenance chapter).
E󰀨ectaCare Range
E󰀨ectaCare 20 E󰀨ectaCare 20 B (Bariatric) E󰀨ectaCare 20 P (Paediatric)
Mattress type Preventive anti-decubitus Preventive anti-decubitus Preventive anti-decubitus
Material of foam Polyurethane foam Polyurethane foam Polyurethane foam
Material of cover
Backing
Coating
100% polyester
100% polyurethane
Cover Water resistant and vapour permeable
See Cleaning and Maintenance for additional information
Weight of mattress 8kg 15kg 3,5kg
Height of mattress 14cm 16cm 10cm
Risk of pressure ul-
cers creation
Medium risk* Medium risk* Medium risk*
Warranty 1 year** 1 year** 1 year**
Stacking limit 15 pieces 15 pieces 25 pieces
*Indication of use based upon interface pressure readings – not a prescriptive criteria. Always refer to a clinician’s judgement.
**In accordance with an appropriate turning and repositioning regime and with the proper usage and cleaning instructions (see
Cleaning and Maintenance chapter).

D9U004PPM-0101_01
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CliniCare Range
CliniCare 10 CliniCare 10 P (Pae-
diatric) CliniCare 20 CliniCare 30
Mattress type Preventive anti-decu-
bitus
Preventive anti-decu-
bitus
Preventive anti-decu-
bitus
Preventive anti-decu-
bitus
Material of foam Polyurethane foam,
visco-elastic foam
Polyurethane foam,
visco-elastic foam
Polyurethane foam,
visco-elastic foam
Polyurethane foam,
visco-elastic foam, PCM
layer
Material of cover
Backing
Coating
100% polyester
100% polyurethane
Cover Water resistant and vapour permeable
See Cleaning and Maintenance for additional information
Weight of mattress 13kg 6kg 16kg 13kg
Height of mattress 14cm 10cm 14cm 14cm
Risk of pressure ul-
cers creation
Very high risk* Very high risk* Very high risk* Very high risk*
Warranty 2 years** 2 years** 2 years** 2 years**
Stacking limit 15 pieces 25 pieces 15 pieces 15 pieces
*Indication of use based upon interface pressure readings – not a prescriptive criteria. Always refer to a clinician’s judgement.
**In accordance with an appropriate turning and repositioning regime and with the proper usage and cleaning instructions (see
Cleaning and Maintenance chapter).
7 Use and Storage Conditions
Respect values of the parameters connected with environment conditions in the chapter Technical Specication during
use and storage of the product.
E󰀨ectaCare 20, E󰀨ectaCare 20 B, E󰀨ectaCare 20 P, PrimaCare 10, PrimaCare 20, PrimaCare 20 B, CliniCare 10, CliniCare
10 P, CliniCare 20 and CliniCare 30 mattresses are not suitable for indoor environments containing ammable gases (ex-
cept oxygen cylinders).
E󰀨ectaCare 20, E󰀨ectaCare 20 B, E󰀨ectaCare 20 P, PrimaCare 10, PrimaCare 20, PrimaCare 20 B, CliniCare 10, CliniCare
10 P, CliniCare 20 and CliniCare 30 mattresses are suitable for continuous operation.
When mattress is not in use:
► Store the mattress at.
► Do not fold the mattress.
► Do not place heavy objects on the mattress surface when not in use.
► Do not allow sharp objects to penetrate the cover coating.
► Keep the mattress clean.
► Regularly inspect the exterior of the mattress.
► Do not store in damp conditions.
► When removing packaging use great care to ensure the cover is not damaged.

D9U004PPM-0101_01
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8 Scope of Delivery and Product Variants
8.1 Delivery
► Upon receipt, check that the shipment is complete as specied on the delivery note.
► Notify the carrier and supplier of any deciencies or damages immediately as well as in writing or make a note on the
delivery note.
8.2 Scope of Delivery
■Mattress
■Instructions for use
8.3 Variants
■ E󰀨ectaCare 20
■ E󰀨ectaCare 20 B
■ E󰀨ectaCare 20 P
■ PrimaCare 10
■ PrimaCare 20
■ PrimaCare 20 B (Bariatric)
■ CliniCare 10
■ CliniCare 10 P (Paediatric)
■ CliniCare 20
■ CliniCare 30