Carilex DualFlex Instructions For Use Manual

Carilex DualFlex Instructions For Use Manual

Hybrid alternating pressure mattress replacement system for dual stage nursing

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DualFlex
Hybrid Alternating Pressure Mattress Replacement System
for Dual Stage Nursing
Instructions for Use
U-2S2602-30631-G V1.2
DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stage Nursing

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Questions and answers

Sharon Jamieson
February 26, 2025

what setting is advisable

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1 comments:
Mr. Anderson
May 14, 2025

The advisable setting for the Carilex DualFlex is to power the equipment or system using an uninterruptible power supply or a battery if continuous operation is required during power variations or mains interruptions. It should also be used in an environment with power frequency magnetic fields and electromagnetic conditions typical of a commercial or hospital setting.

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Summary of Contents for Carilex DualFlex

  • Page 1 DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stage Nursing Instructions for Use U-2S2602-30631-G V1.2 DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stage Nursing...
  • Page 2 This manual describes the hybrid alternating pressure mattress replacement system Validity of the documentation DualFlex. It is part of the device documentation. Do not pass this device to a third party without these Instructions for use. For the confirmation of the up-to-date status of the documentation, the end page of the Instructions for use are marked by edition version.
  • Page 3 Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex About this document Information on the manufactures Representative Manufacturer Carilex Medical GmbH Hanauer Landstraße 291 B 60314 Frankfurt am Main Germany +49 69710475168 For support or complaints Sales and Service...
  • Page 4: Table Of Contents

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Table of Contents 1 Important notes for safe use 5-10 1.1 Designation of the groups of individuals................... 5 1.2 Notes for the users......................... 1.2.1 Instruction........................5 1.2.2 Handing over the device....................6 1.2.3 Maintenance and installation ...................
  • Page 5 Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Table of Contents 5 Cleaning and disinfection 19-21 5.1 Cleaning..........................20 5.2 Disinfection..........................21 6 Care and maintenance 6.1 Inspection..........................22 6.2 Maintenance.......................... 22 7 Troubleshooting 7.1 Error causes and remedies measures................... 23...
  • Page 6: Important Notes For Safe Use

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Important notes for safe use Designation of the groups of individuals Named groups of persons The named groups of persons in these Instructions for use are as follows Operators An operator (surgical suplier, health insurance, clinic, etc.) is any legal person,...
  • Page 7: Handing Over The Device

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Important notes for safe use 1.2.2 Handing over the device Device approval The device may only be used, if the operator has released it for therapeutic or care use and if the hand over was carried out properly and under the supervision of authorised personnel.
  • Page 8: Qualification Requirements On The Hygiene Staff

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Important notes for safe use 1.3.2 Qualification requirements hygiene staff Hygiene measures The nature of hygiene measures are determined by the use environment of the device. • If the device is used in clinical areas (e.g. in hospitals, doctors' offices, etc.) the...
  • Page 9: Attention

    Warranty Warranty terms and conditions The supplier shall ensure the safety and the correct functioning of the DualFlex only under the following conditions: • The device is used for the intended use and maintained only in accordance with the information provided by these Instructions for use;...
  • Page 10: Safety Information And Symbols Of The Instructions For Use

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Important notes for safe use Safety information and symbols of the Instructions for use The safety instructions in this manual are marked with symbols and key words. Signal words like WARNING, CAUTION or ATTENTION designate the classification of the risk.
  • Page 11: Symbols On The Device

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Important notes for the safe use Symbols on the device Class II Double insulation Functional Earth (FE) Type BF Applied Part (IEC 60417-5333) Date of Manufacture Manufacturer Power/Mute Adjust...
  • Page 12: Delivery And Storage

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Delivery and storage Packaging The DualFlex is supplied in sturdy cardboard packaging. All packaging materials are recyclable and can be separated: Packing: Cardboard Delivery control Check immediately after delivery of the device: •...
  • Page 13: Device And Functional Description

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Device and functional description Device description Power unit The power unit 1 is used as the housing for the compressed air unit as well as the compressed air system and also...
  • Page 14: Functional Description

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Device and functional description Functional description Therapeutic effect When used with alternating pressure the skin of the patient is periodically off loaded every 10 minutes. Function of the power unit The compressed air pump in the power unit feeds the alternating pressure cells of the mattress with compressed air.
  • Page 15: Operation And Function Test

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Device and functional description Operation and functional test To perform a functional test and at the initial start-up of the power unit take the following actions: • Fully lay out the mattress. Both air hoses 4 and 5 must be able to move easily without any kinks or pressure points.
  • Page 16 Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Device and functional description Transport: If the patient needs to be transported together with the hybrid alternating pressure mattress system, then the compressed air supply hoses must be disconnected from the controller and connected to close the tubing circuitry 1 .
  • Page 17: Application Of The Hybrid Alternating Pressure Mattress Replacement System

    If the mattress cover is not fixed, the hybrid alternating presure mattress cells may move. For patients there is a risk that they may be injured if placed in an unstable position. Always use the DualFlex coverlet. Without the coverlet, there is a high risk of cross Mandatory bed sizes contamination.
  • Page 18: Preparing The Application

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Application of the Hybrid Alternating Pressure Mattress Replacement System Preparing the application 1. Place the bed in the supine (flat) position. Fix the mattress 2. Fix the mattress with both straps to the bed frame.
  • Page 19: Pressure Control During Therapy

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Application of the Hybrid Alternating Pressure Mattress Replacement System CAUTION Loose power cord may cause tripping and serious injury. Accompanying material caring practices During the use of the hybrid alternating pressure mattress replacement system accompanying material caring practices can be carried out, that support the medical and paramedical measures.
  • Page 20: Cleaning And Disinfection

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Cleaning and disinfection In order to prevent cross-contamination, the cleaning and disinfection of the entire hybrid alternating pressure mattress replacement system must be carried out between uses with different patients.
  • Page 21: Cleaning

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Cleaning and disinfection Cleaning When using pressure mattress replacement system in non-clinical aeas the users or appropriately trained cleaning personnel can carry out the cleaning of the device. Cleaning of the power unit Cleaning of the surfaces of the power unit 1.
  • Page 22: Disinfection

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Cleaning and disinfection Disinfection Hygiene requirements of the operator The operator must be notified about which measures apply to the hybrid alternating pressure mattress replacement system and the actual hygiene directives for disinfection .
  • Page 23: Care And Maintenance

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Care and maintenance Inspection The safe operating condition of the hybrid alternating pressure mattress replacement system has to be checked at each use by the operator or during use by the patients and at least once in a year in particular with regards to the following: •...
  • Page 24: Troubleshooting

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Troubleshooting Error causes and remedies measures Problem Possible cause Measure Power unit is working, but the Contact the supplying medical Damaged air cells or mattress is not inflating. distributor or the technical service of Compressed air hoses.
  • Page 25: Technical Data

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex Technical data Operating Modes The DualFlex is suitable for continuous operation. Model: SR353 Power unit (Air Pump) Dimensions ..................10.2 x 8.7 x 3.1 inch (260 x 220 x 90mm) Weight .........................
  • Page 26 Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex EMC declaration Declaration of Conformity For EN 60601-1-2 Company Name: CARILEX MEDICAL, INC No. 77, KEJI 1ST RD. GUISHAN DIST., TAOYUAN CITY,333 Company Address: TAIWAN (R.O.C.) Trade Name: Carilex...
  • Page 27: Emc Declaration

    Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex EMC declaration Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility environment or in the home healthcare environment The Air Pump declaration – electromagnetic immunity The Air Pump system is intended for use in the electromagnetic environment specified below.

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