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D9U004PPM-0101_01

1 Symbols and Definitions

1.1

1.1 Warning Notices

Warning Notices

1.1.1

1.1.1 Types of Warning Notices

Types of Warning Notices

Warning notices are differentiated by the type of danger using the following key words:

►

CAUTION

warns about the risk of material damage.

►

WARNING

warns about the risk of physical injury.

►

DANGER

warns about the risk of fatal injury.

1.1.2

1.1.2 Structure of Warning Notices

Structure of Warning Notices

SIGNAL WORDS!

Type and source of danger!

► Measures to avoid the danger.

1.2

Instructions

Structure of instructions:

► Perform this step.

Results, if necessary.

1.3

1.3 Lists

Lists

Structure of bulleted lists:

■

List level 1

□□

List level 2

●

List level 3

1.4 Symbols on the Package

KEEP DRY (PROTECT FROM HUMIDITY)

LOW DENSITY POLYETHYLENE RECYCLING SYMBOL

RECYCLING SYMBOL

Содержание CliniCare 10

Страница 1: ...nical Description Passive Mattresses EffectaCare 20 EffectaCare 20 B EffectaCare 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 ...

Страница 2: ...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 differences from the cur...

Страница 3: ...3 3 3Operator 13 4Re use 13 5Description of Mattresses 14 5 1Correct Mattress Orientation 15 5 2Transport Handles 17 6Technical Specification 18 7Use and Storage Conditions 19 8Scope of Delivery and Product Variants 20 8 1Delivery 20 8 2Scope of Delivery 20 8 3Variants 20 9Using the Mattress 21 9 1Preparing the mattress for use 21 9 2Rotating the mattress 21 10Accessories and Replacement Component...

Страница 4: ... DANGER warns about the risk of fatal injury warns about the risk of fatal injury 1 1 2 1 1 2Structure of Warning Notices Structure 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 2Instructions Instructions Structure of instructions Structure of instructions Perform this step Perform th...

Страница 5: ...ARLY 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 ...

Страница 6: ...NING 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 ...

Страница 7: ...1Mattress Serial Label 1 Mattress name one name for different configurations 2 Reference number depending on configuration 3 Mattress dimensions depending on configuration 4 Maximum 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 ...

Страница 8: ...1IM00003 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 reacti...

Страница 9: ...4 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 Ser...

Страница 10: ...king Load PU Polyurethane LDPE Low Density Polyethylene 1 8Definitions 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...

Страница 11: ...t provided is appropriate and fulfils 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 specification support surfaces are designed to complement rather than replace best practice in nursing care e g regular patient turning WARNING...

Страница 12: ... 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 effect on physical proper ties of the mattress core Polyurethane foams can have different colours This has no effect on physical properties of the mattress core The mattress c...

Страница 13: ...e 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 2Contraindications Patient with higher risk of pressure ulcers than the mattress is designed for patients with higher wei...

Страница 14: ...c PrimaCare 10 High resilience foam base Supporting side walls High resilient foam topper Visco elastic memory foam topper PCM top layer Machine hinged profiling Single sided Rotate only design Welded cover seams 180 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 ...

Страница 15: ...Care 10 side view Fig EffectaCare 20 P side view UPPER SIDE UPPER SIDE BOTTOM SIDE BOTTOM SIDE Fig EffectaCare 20 side view Fig EffectaCare 20 B side view UPPER SIDE UPPER SIDE BOTTOM SIDE BOTTOM SIDE 5 1Correct Mattress Orientation ...

Страница 16: ...0 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 ...

Страница 17: ...se 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 ...

Страница 18: ...ys 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 EffectaCare Range EffectaCare 20 EffectaCare 20 B Bariatric EffectaCare 20 P Paediatric Mattress type Preventive anti decubitus Preventive anti decubitus Preventive anti decubitus Material of foam Polyurethan...

Страница 19: ...n accordance with an appropriate turning and repositioning regime and with the proper usage and cleaning instructions see Cleaning and Maintenance chapter 7Use and Storage Conditions Respect values of the parameters connected with environment conditions in the chapter Technical Specification during use and storage of the product EffectaCare 20 EffectaCare 20 B EffectaCare 20 P PrimaCare 10 PrimaCa...

Страница 20: ...otify the carrier and supplier of any deficiencies or damages immediately as well as in writing or make a note on the delivery note 8 2Scope of Delivery Mattress Instructions for use 8 3Variants EffectaCare 20 EffectaCare 20 B EffectaCare 20 P PrimaCare 10 PrimaCare 20 PrimaCare 20 B Bariatric CliniCare 10 CliniCare 10 P Paediatric CliniCare 20 CliniCare 30 ...

Страница 21: ...ure where is the upper side and bottom side of the mattress before putting the mattress cover back on the mattress foam core WARNING Never manipulate with mattress by grabbing it by its seams This may cause damaging the mattress cover and risk of fluids penetrating into the mattress core 9 2Rotating the mattress The LINET PrimaCare and CliniCare products detailed in this manual are single sided Si...

Страница 22: ... will be dependent on application and mattress type Three styles of extension are available Standard CMHR foam layers Comfort CMHR base with a visco layer top Bariatric High durability CMHR foam layers Replacement foam and covers are available where necessary For more information on the following items please contact your local LINET distributor Fig Correct placement of the top cover flap 1 Top co...

Страница 23: ...ic based cleaners Cleaning by neutral water and soap followed by rinsing with water is su fficient to clean this product Solvent containing alcohol bleaching or abrasive products can be harmful On request the manufacturer will provide list of cleaning agents and disinfectants tested with the mattresses To disinfect in situ use a 0 1 sodium hypochlorite solution 1 000ppm chlorine If required a 1 ch...

Страница 24: ...ch For disposal of packaging materials after installation of products contact your sales representative or manufacturer s customer service about the possibility of a free take back of packaging through an authorized company more details on www linet cz 12 2Disposal 12 2 1Within Europe To dispose of the mattress Ensure that the mattress is fully decontaminated prior to disposal The equipment must n...

Страница 25: ... the following standards ISO 9001 ISO 14001 ISO 13485 MDSAP Medical Device Single Audit Program All LINET EffectaCare PrimaCare and CliniCare mattresses are considered as medical devices and therefore feature the CE mark in accordance with EU Medical Device Regulation 2017 745 Manufacturer is committed to advancing responsible care continuously improving environmental health and safety knowledge a...

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