Trimano Support Arm

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TRIMANOSupport Arm

AR

-164

0A

R-1

641

AR

-164

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OPERATING INSTRUCTIONSThese operating instructions contain important information to enable you to operate all the components of the Arthrex TRIMANO (AR-1640) safely, including its accessories. Read the operating instructions carefully before using the system and keep them where they can be easily accessed by all the operating personnel. Familiarize yourself with all warning and cautionary notices and ensure you follow them.

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1

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Copyright noticeAll rights reserved.Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. Copyright Arthrex GmbH

Subject to technical modification!Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development.

AR-1640

CE

Arthrex Inc.1370 Creekside Blvd.Naples, Florida 34108-1945, USA+1-(800) 934-4404

EC REPArthrex GmbH Erwin-Hielscher-Strasse 9 81249 Mnchen, Germany Tel: +49 89 909005-0

AR-1641

CE

MAQUET GmbHKehler Str. 3176437 RastattBaden-Wuerttemberg, Germany+49 (0) 7222 932-0

Manufactured forArthrex Inc.1370 Creekside Blvd.Naples, Florida 34108-1945, USA+1-(800) 934-4404

Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 Mnchen, Germany Tel: +49 89 909005-0

AR-1644

CE0086

Arthrex Inc.1370 Creekside Blvd.Naples, Florida 34108-1945, USA+1-(800) 934-4404

EC REPArthrex GmbH Erwin-Hielscher-Strasse 9 81249 Mnchen, Germany Tel: +49 89 909005-0


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Table of Contents

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1 INTROdUCTION1.1 ENVIRONMENTAL PROTECTION ..................................................................................... 5

1.1.1 PACKAGING ....................................................................................................................... 51.1.2 ARTHREX PRODUCTS ...................................................................................................... 5

1.1.3 DISPOSABLES ................................................................................................................... 51.2 HOw TO USE THESE OPERATING INSTRUCTIONS ...................................................... 5

1.2.1 GENERAL ........................................................................................................................... 5 1.2.2 SyMBOLS ........................................................................................................................... 5

1.2.2.1 ACTIONS AND RESPONSES ............................................................................................ 5 1.2.3 DEFINITIONS ..................................................................................................................... 6

1.2.3.1 DESIGN OF SAFETy NOTES ............................................................................................ 61.2.3.2 DESIGN OF OTHER NOTES ............................................................................................. 61.2.4 SyMBOLS USED ................................................................................................................ 7-81.3 PICTORIAL GUIDE ............................................................................................................. 91.3.1 PICTORIAL VIEw OF TRIMANO ........................................................................................ 91.3.2 PICTORIAL VIEw OF STERILE SET (AR-1644) ................................................................ 101.4 BASIC REQUIREMENTS ................................................................................................... 111.4.1 USE IN ACCORDANCE wITH THE INTENDED PURPOSE ............................................. 111.4.2 APPLICABLE STANDARDS ............................................................................................... 111.4.3 INTENDED PURPOSES ..................................................................................................... 121.4.3.1 TRIMANO (AR-1640) .......................................................................................................... 121.4.3.2 QUICK CHANGE COUPLING (AR-1641) ........................................................................... 121.4.3.3 BEACH CHAIR STERILE SET (AR-1644) .......................................................................... 12

2 SAfETy NOTES2.1 GENERAL SAFETy NOTES ............................................................................................... 13-15

3 OPERATION ANd USE 3.1 GENERAL ........................................................................................................................... 16 3.2 ASSEMBLy ......................................................................................................................... 17

3.2.1 MOUNTING TRIMANO ON OPERATING TABLE ............................................................... 183.2.2 MOUNTING THE QUICK CHANGE COUPLING wITH STERILE COVER ........................ 19-203.2.3 BEACH CHAIR STERILE SET ............................................................................................ 203.2.3.1 MOUNTING THE BEACH CHAIR STERILE SET ............................................................... 203.2.3.2 PLACING PATIENTS ARM ................................................................................................. 213.2.3.3 SECURE PATIENTS ARM .................................................................................................. 213.3 ADjUSTING THE RETAINING ARM ................................................................................... 223.3.1 REMOVING THE ARM REST ............................................................................................. 23

3.4 DISASSEMBLy ................................................................................................................... 243.4.1 REMOVING THE QUICK CHANGE COUPLING ................................................................ 24 3.4.2 DETACHING TRIMANO ...................................................................................................... 25


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4 ClEANING ANd dISINfECTION4.1 GENERAL ...........................................................................................................................264.1.1 BASIC INSTRUCTIONS .....................................................................................................26-274.1.2 STAINLESS STEEL SURFACES ........................................................................................274.1.3 MECHANICAL DECONTAMINATION .................................................................................284.1.3.1 MECHANICAL DECONTAMINATION: QUICK CHANGE COUPLING (AR-1641) ..............28

4.2 CLEANING ..........................................................................................................................29 4.2.1 GENERAL ...........................................................................................................................29

4.2.2 CLEANING PROCEDURE ..................................................................................................29 4.3 DISINFECTION ...................................................................................................................30 4.3.1 GENERAL ...........................................................................................................................30

4.3.2 SUITABLE DISINFECTANTS ..............................................................................................304.3.3 DISINFECTION PROCEDURE ...........................................................................................304.4 CLEANING AND DISINFECTION PROCEDURES .............................................................314.4.1 MANUAL CLEANING, DISINFECTION AND STERILISATION PROCEDURES ................314.4.2 MECHANICAL CLEANING AND DISINFECTION PROCEDURES ....................................324.5 DISASSEMBLy OF RELEASE HANDLE ............................................................................324.6 ASSEMBLy OF RELEASE HANDLE ..................................................................................334.7 AFTER CLEANING/DISINFECTION/STERILISATION .......................................................34

5 INSPECTIONS5.1 VISUAL AND FUNCTIONAL INSPECTIONS ......................................................................35

5.2 MAINTENANCE ..................................................................................................................35 5.3 REPAIR ...............................................................................................................................36

6 TEChNICAl SPECIfICATIONS 6.1 wEIGHT ..............................................................................................................................37

6.2 AMBIENT CONDITIONS .....................................................................................................37

7 APPROvEd ACCESSORIES7.1 APPROVED ACCESSORIES .............................................................................................37

Table of Contents


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1 Introduction

1.1 Environmental protection

1.1.1 PackagingThe packaging is made of materials compatiblewith the environment. Arthrex will dispose ofthe packaging materials upon request.

1.1.2 Arthrex productsArthrex will take back used products or thosewhich are no longer in service. Please contact your Arthrex Distribution for more detailed information.

1.1.3 disposablesDisposables must be handled and disposed ofpursuant to national regulations.

1.2 how to use these operating instructions

1.2.1 GeneralThese operating instructions are provided tofamiliarize you with the features of this product. They are subdivided into several chapters.

Please note: Please read these operating instructions carefully and completely before using the product for the first time. Always proceed in accordance with the information contained herein. Store these operating instructions in a location near the product.

1.2.2 Symbols

1.2.2.1 Action and responsesThe symbol identifies an action taken bythe user while the symbol identifies thereaction that this will induce in the system.

Example: Turn on the light switch. Lamp lights up.

Introduction Environmental Protection 1


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1.2.3 Definitions

1.2.3.1 design of safety notes

Pictogram descriptor Text

D A N G E R !Indicates a direct and immediate riskto persons, which may be fatal orresult in most serious injury.

The text for the safetynote describes the typeof risk and how to avert it.

D A N G E R !Indicates a potential risk to personsor property which may result in health hazard or grave property damage.

D A N G E R !Indicates a potential risk to propertywhich may result in property damage.

Pictogram descriptor Text

N O T E

Supplementary assistance or further useful information without potential injury to persons or property damage is described in the text of the note.

1.2.3.2 design of other notes

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IntroductionHow to Use these Operating Instructions1

Fig. 2: Design of other notes


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Introduction How to Use these Operating Instructions 1

1.2.4 Symbols used

Pictogram Identification

Labeling for Class I products, developed and marketed in compliance with Medical Device Directive 93/42/EU.

Labeling for products which were developed and are marketed in compliance with the 93/42/EEC Medial Products Directive. Class Is, Im, IIa, IIb and III products are also marked with the identifying number for the notified body.

Designates products which can be sterilized in the autoclave at up to 134 C.

Designation in compliance with the EN 980 standard.Symbol for Manufacturer.

Labeling in compliance with the EN 980 standard.Symbol for Manufacturing date.

Marking in accordance with the EN 980 standard.Symbol for Not to be reused.

Marking in accordance with the EN 980 standard.Symbol for Lot identifier.

Packaging label. Symbol for Keep dry.

Labeling in compliance with the EN 980 standard.Symbol for Serial number.

Labeling as per EN 980 standard. Symbol for Order number.

Labeling in compliance with the EN 980 standard.Symbol for Do not sterilize again.

134 C

2

LOT

2STERILIZE

0 1 2 3

SN

REF

Fig. 3: Symbols (Part 1 of 2)


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Introduction How to Use these Operating Instructions

Pictogram Identification

Marking in compliance with the EN 980 standard.Symbol for Can be used until.

Labeling in compliance with the EN 980 standard.Symbol for Sterilization with ethylene oxide.

Labeling in compliance with the EN 980 standard. Symbol for Do not use when packaging is damaged.

Labeling in compliance with the EN 980 standard. Symbol for Keep away from direct sunlight.

Symbol for Observe operating instructions.

STERILE EO

1

Fig. 3: Symbols (Part 2 of 2)


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1.3 Pictorial guide

1.3.1 Pictorial view of TRIMANO

IntroductionPictorial Guide 1

Fig. 4: Pictorial view of TRIMANO

1 TRIMANO Support arm (AR-1640)2 Release handle3 Quick change coupling (AR-1641)


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IntroductionPictorial Guide1

1.3.2 Overview Sterile set (AR-1644)

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Fig. 5: Pictorial view of Beach Chair Sterile Set (AR-1644)

1 Cover2 Self adherent wrap3 Beach Chair arm holder


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1.4 Basic requirements

1.4.1 Use in accordance with the intended purposeThis product is a Class I medical device accordingto the Medical Device Directive 93/42/EEC.This product is to be used exclusively in humanmedicine. Patients may be placed on the device and put in position only under the supervision of medicalpersonnel.

1.4.2 Applicable standardsThe product satisfies the basic requirementsset forth in Annex I to the 93/42/EU Directivedrafted by the Medical Products Council(Medical Device Directive) as well as theapplicable national codes and the MedicalProducts Act in Germany. This is certified bycompliance with harmonised standards such asIEC 60601-1 and related standards and therespective special sections.

AccessoriesAccessories or combinations of accessoriesmay be utilised only when and as indicated inthese operating instructions.Use other accessories, combinations and parts subject to wear only if these are intendedexpressly for the application and will notadversely affect performance features or safety requirements.

Introduction Basic Requirements 1


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1.4.3 Intended purposes

1.4.3.1 TRIMANO (AR-1640)TRIMANO (AR-1640) is used, in combinationwith specific accessories, to accommodate apatients arm immediately before, during andafter surgical interventions as well as for examinationand treatment.TRIMANO is mounted to the accessory rail ofoperating tables and can be fixed freely invarious positions. The fixing may be manuallyreleased quickly (one-handed operation). Afteradjusting and releasing the operating element,the retaining arm is independently locked in thenew position. Depending on the application,ensure sterility.

TRIMANO may only be used in conjunctionwith the following accessories: Quick change coupling (AR-1641) Sterile set (AR-1644)

1.4.3.2 Quick change coupling (AR-1641)The quick change coupling (AR-1641) isused as intermediate element designed to couplethe Sterile set (AR-1644) to TRIMANO.

1.4.3.3 Beach Chair Sterile set (AR-1644)The sterile set (AR-1644) is used to cover the retaining arm.

The sterile set AR-1644 includes: 1 x Sterile cover 1 x Self adherent wrap 1 x Arm holder

Introduction Basic Requirements1


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2 Safety notes

2.1 General safety notes

D A N G E R !Potentially fatal! Hazard resulting from improper handling.Be absolutely sure to follow the operating instructions for your mobile operatingtable or operating table system.

D A N G E R !Potentially fatal!Vital functions can be impaired through incorrect positioning.Position the patient correctly and maintain continuous observation.

W A R N I N G !Risk of injury!Improper positioning can be detrimental to patient health.Always position the patient correctly and maintain continuous observation.

W A R N I N G !Risk of injury!A worn or damaged product/accessory can cause injuries.Only use products/accessories which are in perfect condition.

W A R N I N G !Risk of injury due to material failure!The maximum load for this product is its share of the load imposed by a patientweighing 180 kg.

D A N G E R !Potentially fatal!The maximum load placed on the product may not exceed the appropriate proportionof a patient weighing 180 kg. Restrictions result from the permissible overallload, among other things, of accessory rails when using operating tables witha low maximum load capacity. Be absolutely sure to follow the operating instructionsfor your mobile operating table or operating table system.

W A R N I N G !Risk of injury!Patient may be endangered as a result of incorrect use.Follow the operating instructions for all accessories.

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Safety NotesGeneral Safety Notes 2


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W A R N I N G !Risk of injury!Accessories which are improperly mounted may come loose and cause injuries.Use Arthrex accessories exclusively and be sure to affix them correctly.Use accessories made by other manufacturers only after obtaining writtenpermission from Arthrex.

W A R N I N G !Risk of injury!Collisions between accessories, the operating table, the table top and the patientcan occur when adjusting or moving the operating table or table top or whentransferring the table top.Observe the adjustment procedure and avoid collisions.

W A R N I N G !Risk of burning! Using high-frequency devices, defibrillators and defibrillator monitors exposes thepatient to burn hazard due to contact with metal components in the device oraccessories and/or if resting on wet drapes or electrically conductive padding.Avoid any contact between the patient and metallic components; never use moistof wet surgical drapes. Be absolutely sure to comply with the manufacturers operating instructions!

W A R N I N G !Risk of injury! Products/accessories not attached properly may loosen and cause injuries.Always ensure that all locking elements (offset lever, setting clamps, catchs etc.)of the product/accessory are closed and movable parts are fixed properly. Checklocking after every adjustment procedure.

W A R N I N G !Risk of injury!If locking elements (offset levers, handle screws, locking mechanisms etc.) areopened, the clamps are released and the product can be moved.Before opening the locking elements, hold the individual parts securely. Makesure that all locking elements are closed after each adjustment procedure.

W A R N I N G !Risk of injury!

whenever the product is mounted and adjusted, there is a danger of pinching andshearing to the staff, patient and accessories. Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.

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Safety NotesGeneral Safety Notes2


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W A R N I N G !Risk of mobile operating table tipping over!The product affects the centre of gravity of the mobile operating table.

when positioning the patient, observe the operating instructions of the mobileoperating table.

W A R N I N G !Risk of injury!During the adjustment procedures, the operating table / accessories may collidewith accessories or downward pointing parts and thus may cause propertydamage and injuries. During the adjustment procedures, always pay attention to the operating table and accessories and avoid collisions. Ensure that tubes, cables and drapes are not trapped.

C A U T I O N !Property damage!The joints of the retaining arm may not be lubricated or oiled. It may lead to irreparabledamage to the functioning of the unit.

D A N G E R !Risk of infection!Do not use the sterile set when the packaging of the sterile set is damaged.

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Safety NotesGeneral Safety Notes 2


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3 Operation and use

3.1 General

W A R N I N G !Risk of infection!If the retaining arm is used in areas with varying hygienic requirements, there is arisk of infection. Ensure that the retaining arm is always in the sterile area while being used. If the retaining arm is outside the sterile area, treat the retaining arm in accordancewith the hygiene guideline and the instructions given in the chapter Cleaningand disinfection.

C A U T I O N !Property damage!TRIMANO may only be used with accessories designed specifically for this purpose.Do not mount any other accessories onTRIMANO.

C A U T I O N !Property damage!TRIMANO is used to support the arm of the patient. No other additional forces,e. g. by leaning on or resting on, may act on TRIMANO.

C A U T I O N !Property damage!During surgery, TRIMANO must be covered by a sterile cover to protect it against

liquids.

C A U T I O N !Property damage! High temperatures, moisture and humidity can damage the product.Protect the product against moisture and humidity, clean by wipe disinfection only.Do not store close to radiators and protect from high solar radiation.Do not expose the product to large impacts and vibrations, the product is not designedfor impulse loads.

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Operation and UseGeneral3


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3.2 Assembly

N O T EThe sterile set (AR-1644) is required for the proper use of the retaining arm. The Set consists of a metal armrest, with integrated padding, as well as a self-adherent wrap and a sterile cover. All products of the sterile set are disposables.The use of TRIMANO is only approved with the intended sterile set.

N O T EAll of the products used, except the retaining arm, which is used with a sterilecover, may only be used in sterile condition! The quick change coupling is supplied in a non-sterile conditionand must be cleaned and sterilized before the first use.

1 Mounting positionPosition for mounting/detaching the retainingarm.

2 Neutral positionPosition for mounting the sterile cover. Adjusting the retaining arm (>>Page 22).

Operation and UseAssembly 3

Fig. 6: Mounting position/neutral position


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3.2.1 Mounting TRIMANO on operating table

C A U T I O N !Property damage!The clamp of the retaining arm may damage the patient covering.Ensure that the retaining arm is not fastened on a patient covering. Mount the retainingarm directly to the accessory rail of the operating table.

W A R N I N G !Risk of injury resulting from collision!During transport of the positioned patient with mounted retaining arm, position theretaining arm close to the body.

N O T EMount TRIMANO in the seat plate area, between the hip and the knee.

Mounting TRIMANO Put TRIMANO in mounting position. Open the fastening screw (1) of the clamp (2) completely. Put the clamp on the accessory rail. The fastening screw points upwards. Tighten fastening screw. TRIMANO is mounted to the accessory rail of the operating table. Make sure that it is properly attached.

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Operation and UseAssembly3

Fig. 7: Mounting TRIMANO


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3.2.2 Mounting the quick change coupling with sterile cover

N O T EAfter mounting the sterile cover, check to ensure full and sterile coverage of nonsterileareas.

Sticking the sterile cover to the quickchange coupling Tape the end of the sterile cover to the center of the black, protruding area of the quick change coupling using the adhesive tape (1). Make sure it is firmly attached.

Mounting the quick change couplingThe structure of both sides of the quick changecoupling is identical and can be mounted on theretaining arm from both sides. Fit the quick change coupling (1) to the locking device (2) of the retaining arm and move slightly back and forth. The locking device engages with an audible click. The quick change coupling is mounted on the retaining arm. Make sure that it is properly attached.


Fig. 8: Sticking the sterile cover to the quick change coupling

Fig. 9: Mounting the quick change coupling


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Applying the sterile coverRequirement:TRIMANO is in a neutral position. Pull sterile cover (1) completely over the retaining arm as far as the accessory rail. Retaining arm is protected from splashes.

Operation and UseAssembly3

3.2.3 Beach Chair Sterile Set

3.2.3.1 Mounting the Beach Chair Sterile Set

Fit arm holder (1) to the quick coupling adapter (2) and rotate slightly to fully engage. The arm holder will engage the

coupling adapter with an audible click. Make sure that it is properly attached.

Fig. 10: Applying the sterile cover

Fig. 11: Mounting the Beach Chair Sterile Set (AR-1644)

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3.2.3.2 Placing the Patients Arm

Position the Trimano to allow for easy placement of the patients arm into the arm rest. Make sure the patients fingers wrap

around the cushioned rod of the arm rest.

WARNING: Risk of injury: If the patients fingers do not wrap around the arm rest, the patients arm may slip.

3.2.3.3 Secure the Patients Arm

wrap the arm holders foam (1) around the patients arm and secure with the attached Velcro strips. wrap the entire assembly with the included self-adherent wrap (2) making sure to secure the hand and fingers as well. The locking mechanism should not be covered with the self-adherent wrap to allow the arm to be detached from the support arm during surgery.

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correct

incorrect

Fig. 12: Placing the Patients Arm

Fig. 13: Securing the Patients Arm

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3.3 Adjusting the retaining armThe retaining arm has six swivel joints, which may be used to fix the retaining arm in different positions.

W A R N I N G !Risk of injury due to unintended movements downwards!

when opening the release handle, the clamps of the swivel joints are releasedand the retaining arm can be moved. It swivels downwards due to its own weightand the weight of the patient. Before opening the release handle, firmly hold the retaining arm with both hands. After every adjustment process, ensure that the release handle locks the retaining arm correctly and no foreign bodies are pinched.

C A U T I O N !Property damage!

when pushing the release handle, it may jam if foreign bodies are drawn in. when pushing the release handle ensure that no foreign bodies (e. g. sterile cover,

glove) are clamped.

C A U T I O N !Property damage!To adjust the retaining arm, push the release handle as far as it will go. Otherwisethe retaining arm may be damaged.To adjust the retaining arm, push the release handle as far as it will go.

N O T EExcessive load (e. g. excessive traction on TRIMANO) may cause the mechanismto jam slightly. In this case, take the load off TRIMANO, if necessary, detach thearm rest and push in the handle with increased force to open the joints.

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Operation and Use Adjusting the Retaining Arm3

Adjusting the retaining arm Release the retaining arm upwards (1). Easy unlocking is possible. After releasing, the retaining arm does not

fall back unintentionally Push in the release lever (1) as far as it will go and hold it. The locking devices of the swivel joints are

released. Swivel the retaining arm to the desired position. Release the release lever. Swivel joints of the retaining arm are

locked. Retaining arm is locked in the desired position.

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Fig. 14: Adjusting the retaining arm


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3.3.1 Removing the arm restDuring surgery, the arm rest may be detached from the quick change coupling and mounted again in sterile condition. This allows the arm to be moved freely without TRIMANO.

N O T ERemember that the upper release buttons are pressed to detach the arm rest. Ifthe bottom release buttons are pressed, the connection between the quickchange coupling and the retaining arm is unlocked.

Operation and Use Removing the Arm Rest 3

Fig. 15: Removing the arm rest

Removing the arm rest Press in both upper release buttons (1) of the quick change coupling adapter simultaneously to unlock the arm rest. Arm rest is unlocked. Take the arm rest off the quick change coupling

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3.4 disassembly

3.4.1 Removing the quick change coupling

Removing the quick change coupling Press in both bottom release buttons (1) of the quick change coupling simultaneously. The quick change coupling is unlocked. Remove the quick change coupling from the retaining arm.

Operation and Use Disassembly3

Fig. 16: Removing the quick change coupling


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3.4.2 detaching TRIMANO

detaching TRIMANO Put TRIMANO in the mounting position. Open fastening screw (1) of the clamp (2) completely. Remove the clamp from the accessory rail.

Operation and Use Disassembly 3

Fig. 17: Detaching TRIMANO


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4 Cleaning and disinfection

4.1 GeneralThe product must be cleaned and wipe or spray disinfected after every use.

N O T EClean and sterilize adapter (AR-1641) before initial use and after every use.

4.1.1 Basic instructions

D A N G E R !Risk due to incorrect use of detergents and disinfectants!It is strictly advised to observe the manufacturer instructions regarding how to usethe detergents and disinfectants as well as the valid hospital hygiene rules.

W A R N I N G !Risk of infection!Particles of grime may become encapsulated and lead to the product not reachingthe desired germ-reduction after disinfection.Before disinfection, the product must be cleaned thoroughly of contamination andencapsulated particles of grime and then be dried.

W A R N I N G !Risk of infection!Product may be contaminated. Always wear gloves for cleaning and disinfection.

C A U T I O N !Improper cleaning and disinfection can cause property damage!Perform visual and functional inspections after each cleaning and disinfection

process.

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Cleaning and disinfectionGeneral4

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C A UT I O N !Improper cleaning and disinfection can cause property damage!Do not use the following products for cleaning and disinfection: Products containing alcohol (e. g. hand disinfectants) Halogenides (e. g. fluorites, chlorides, bromides, iodides) Dehalogenating compounds (e. g. fluorine, chlorine, bromine, iodine) Products that may scratch the surface (e. g. scouring agents, wire brushes, wire wool) Standard commercial solvents (e. g. benzene, thinner) Water containing iron particles Cleaning sponges containing iron Products containing hydrochloric acidUse approved detergents and disinfectants only. Use a soft, lint free cloth or a softnylon brush to clean the product.

C A UT I O N !Improper cleaning and disinfection can cause property damage!Use only as much detergent and disinfectant as required. Thoroughly wipe off anyexcess detergent and disinfectant with a damp, soft cloth. Avoid surface drying ofexcess detergents and disinfectants.

4.1.2 Stainless steel surfaces

N O T EIf metal surfaces corrode, despite regular cleaning, the surfaces may be cleanedwith special detergents such as Perr active or Helotil.

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Cleaning and disinfectionGeneral 4


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4.1.3. Mechanical decontamination

4.1.3.1 Mechanical decontamination: Quick change coupling (AR-1641)

C A U T I O N !Property damage!Using non-colour-fast drapes can cause discolouration of surfaces.Always use colour-fast drapes.

C A U T I O N !Property damage due to live steam!The natural aging of plastics will be accelerated by autoclaving using live steam.Perform visual and functional inspections after every autoclaving.

C A U T I O N !Visual and functional inspections! Proper autoclaving allows the processing of the quick change coupling at least200 times. Perform visual and functional inspections before every use.

N O T EInspect all components for proper functionality before use.

Place the product in a packaging suitable for sterilization, e. g. a standard sterilization container, in the autoclave. Place the product in the autoclave in such a way that all outer and inner surfaces are accessible for the sterilization medium.

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Cleaning and disinfectionGeneral4

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4.2 Cleaning

4.2.1 General

N O T EIn the event of very dirty product surfaces, carry out an additional disinfectionprocedure before cleaning the product.

N O T EUse only all-purpose cleaners which are slightly alkaline (soap solution) andcontain tensides and phosphates as the active cleaning agents. In the event of heavily contaminated surfaces, use concentrated multi-purpose detergent. (see page 27)

C A U T I O N !Improper cleaning can cause property damage!Residues of physiological saline solutions (e. g. sodium chloride) can attack thesurfaces of the product.Remove residues of physiological saline solutions with a cloth dipped in cleanwater. Then dry the product with a dry, lint free cloth.

C A U T I O N !Improper cleaning can cause property damage!Do not splash detergents directly into gaps or openings and do not use pressurewashers! Do not immerse TRIMANO in liquid for cleaning!

4.2.2 Cleaning procedure Use the correct dose of multi-purpose detergent with water for the degree of surface contamination and in accordance with the instructions of the detergent manufacturer. Thoroughly wipe off the product with a soft cloth slightly wetted in a multi-purpose detergent solution. Ensure that the product is free of contamination and encapsulated particles of grime.

Thoroughly wipe off the product with a soft cloth dipped in clean water. Ensure that the product is free of detergent residues. Dry product with a dry, absorbent and lint free cloth. This will help to reduce pathogen growth on the products surface.wipe or spray disinfect the product after every cleaning.

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Cleaning and disinfectionCleaning 4


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4.3 disinfection

4.3.1 General

W A R N I N G !Explosion hazard!Agents containing alcohol can form explosive vapour mixtures and ignite wherehigh-frequency equipment is being used.Do not use agents containing alcohol where high-frequency equipment is beingused.

C A U T I O N !Material damage due to excessive exposure times!Exceeding the specified exposure time of the disinfectant may damage the

surfaces.Remove disinfectant residues with a cloth dipped in clean water. Then dry theproduct with a dry, lint free cloth.

4.3.2 Suitable disinfectantsTo carry out disinfection, only use surface disinfectants based on the following combinations ofactive ingredients: Aldehydes Quaternary compounds or Guanidine derivatives

4.3.3 disinfection procedure wipe or spray disinfect the product in accordance with the instructions of the detergent manufacturer each time after the product is cleaned. Thoroughly wipe off the product with a soft cloth dipped in clean water.

Ensure that the product is free of disinfectant residue. Dry product with a dry, absorbent and lint free cloth. Perform visual and functional inspections.

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Cleaning and disinfectionDisinfection4

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4.4 Cleaning and disinfection procedures

Different cleaning and disinfection procedures may be used for the various components, depending on the properties of the materials.

Components Cleaning disinfection Sterilizationwith live steam

Quick changecoupling(AR-1641)

Ultrasonic bath (5 minutes, frequency 35 kHz) in low- alkaline detergent solution (e.g. Dr. weigert MediClean 1 % (v/v) in tap water*). Then, by using a soft non- metallic brush (e.g. medium-hard toothbrush), the entire outer surface, especiallythe hardly accessible parts(metal parts) of the componentsare brushed under running tap water until no residues are visible (for at least 1 minute). All sliding surfaces, recesses and especially the central openings at the metal sides are flushed under running tap waterfor at least 45 seconds each side. During this process, move all movable parts. Use a dispo-sable syringe (e.g. 60 ml) and 200 ml tap water* to rinse every flushing channel.Then rinse all accessible pointswith demineralised water for atleast 10 seconds. Finally, dry allsurfaces with a lint-free cloth.

Immerse in disinfection solution(30 minutes) (e.g. neodisher SeptoMED, Dr. weigert, 2% (v/v) at 20 C 2 C in tap water*).Before immersion use adisposable syringe (60 mlsyringe) to rinse everyflushing channel with 200 ml solution. To remove air bubbles move the components by hand in the solution for 10 seconds at thebeginning of immersion. Finally, immerse componentsin cold, demineralizedwater (1 minute).

Live steamtemperature: 134 C; 3 xfractionated prevacuum; sterilization (at least 4 minutes).Or:Live steamtemperature: 132 C; 3 xfractionated prevacuum; sterilization (at least 6.5 minutes).

Sterile set Disposable. Only intended for single use.

*Tap water: minimum quality requirements: drinking water, temperature 30 C ( 3 C)

4.4.1 Manual cleaning, disinfection and sterilization procedures

Cleaning and disinfection Cleaning and Disinfection Procedures 4

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Fig. 18: Cleaning and disinfection procedures


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Components Cleaning disinfection

Quick change coupling (AR-1641) Connect every flushing channel of the components with an injector. Rinse with cold tap water* (1 minute). Cleaning at 55 C (- 0 C, + 3 C, 5 minutes) with detergents, e.g. neodisher MediClean (0.5% v/v). Neutralization with cold tap water* (2 minutes). Rinse with cold tap water* (1 minute).

Thermal disinfection at 93 C(+ 5 C, - 0 C, 5 minutes)with demineralized water.

Sterile set Disposable. Only intended for single use.

*Tap water: minimum quality requirements: drinking water

4.4.2 Mechanical cleaning and disinfection procedures

4.5. disassembly of release handleThe release handle can be disassembled for cleaning/disinfection purposes.

disassembly of release handle Push safety pin (1) out of the boring with a thin object, e. g. a needle cover. Release lever, load transmission pin and safety spring are released and can be removed from the release handle.

Cleaning and disinfectionDisassembly of Release Handle4

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Fig. 19: Cleaning and disinfection procedures

Fig. 20: Disassembly of release handle


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4.6 Assembly of release handle

N O T EIf the release handle is mounted improperly, the joints of the retaining armcannot be released by pushing the release handle. If this is the case, disassembleand mount the release handle once again.

N O T EAlways ensure that the safety spring is inserted properly during assembly. A missing safety spring may cause the elements to slip and thus lead to malfunctionduring use.

Mounting the release handle Insert safety spring (1) into release handle. The safety spring is positioned on the metal pin. Insert and hold the load transmission pin (2) in the recess on the back of the release lever (3).

Insert the release lever (3) with the load transmission pin (2) in such a way in the release handle that the load transmission pin is positioned on the safety spring.

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Cleaning and disinfectionAssembly of Release Handle

Fig. 21: Mounting the release handle



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Mounting the release handle Insert the release lever (1) upward and plug the safety pin (2) in the boring. The safety pin engages. Perform functional test.

Cleaning and disinfectionAssembly of Release Handle4

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4.7 After Cleaning/disinfection/Sterilisation


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5 Inspections5.1 visual and functional inspectionsFor correct operation it is necessary to havevisual and functional inspections performed bya trained person each time before using theoperating table, at least once a day. The result of the visual and functional

inspections has to be documented and mustinclude the date and signature of the personwho performed the inspections. The followingtable can be used as a model.

Suggestion:

No. Inspection defects are present No defects1 Has the product been cleaned

and disinfected according to thehygiene guideline?

Do not use the product any longer. Clean and disinfect the product according to the guideline.

Comment:

2 Is there damage to mechanical parts? Do not use the product any longer. Inform service personnel.

Comment:

3 Is it possible to operate all adjustment features of the product?

Do not use the product any longer. Inform service personnel.

Comment:

4 (Space for other tests)

Comment:

5.2 MaintenanceThis product is maintenance-free. wear causedby use and aging can impair functions of theproduct which are relevant to safety.Check the condition of the product each timebefore using it.If defects are detected, the product should notcontinue to be used.

Note the defects and the model numberwhich can be found on the type plate and informthe local Arthrex representative.

Inspections Visual and Functional inspections 5

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Fig. 24: Visual and functional inspections


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5.3 RepairA defective product may not be used and maynot be repaired by yourself. There are no user serviceable components. Inform the responsibleArthrex representative about: Defect Product number (see type plate) If available, serial number

(see type plate) Construction year (see type plate)

Hotline for US:866-267-9139 Refer to the following address for the hotlinenumbers for other countries:www.arthrex.com

Position of the type plate (1).

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Position of the type plate (1).

Fig. 25: Type plate of retaining arm

Fig. 26: Type plate of quick change coupling


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6 Technical specifications

6.1 Weight

6.2 Ambient conditions

Classification as per Medical Products Directive93/42/EEC

Class I

Support arm Approximately 3.4 kgQuick change coupling Approximately 0.6 kg

Temperature -20 C to +50 C (during shipping)+10 C to +40 C (in operation)-20 C to +30 C (storage)

Relative humidity10 % to 95 % (during shipping)30 % to 75 % (in operation)

Atmospheric pressure500 hPa to 1060 hPa (during shipping)700 hPa to 1060 hPa (in operation)

Technical Specifications/Approved AccessoriesGeneral 6/7

7 Approved accessories7.1 Approved accessories

AR-1641 Quick change coupling adapter AR-1644 TRIMANO Beach Chair Kit sterile set


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Notes:

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Trimano Support Arm

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Transcript of Trimano Support Arm