TRIMANO Support Arm Operating Instructions

Copyright notice All 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

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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

AR-1641

AR-1644

CE

CE

CE0086

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

MAQUET GmbH Kehler Str. 31 76437 Rastatt Baden-Wuerttemberg, Germany +49 (0) 7222 932-0

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

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

Manufactured for Arthrex Inc. 1370 Creekside Blvd. Naples, Florida 34108-1945, USA +1-(800) 934-4404 Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 2

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

Table of Contents

1 Introduction 1.1 Environmental protection... 5 Packaging... 5 1.1.1 1.1.2 ARTHREX products... 5 Disposables... 5 1.1.3 1.2 How to use these operating instructions... 5 General... 5 1.2.1 Symbols... 5 1.2.2 1.2.2.1 Actions and responses... 5 Definitions... 6 1.2.3 1.2.3.1 Design of safety notes... 6 1.2.3.2 Design of other notes... 6 1.2.4 Symbols used... 7-8 1.3 Pictorial guide... 9 1.3.1 Pictorial view of TRIMANO... 9 1.3.2 Pictorial view of sterile set (AR-1644)... 10 1.4 Basic requirements... 11 1.4.1 Use in accordance with the intended purpose... 11 1.4.2 Applicable standards... 11 1.4.3 Intended purposes... 12 1.4.3.1 TRIMANO (AR-1640)... 12 1.4.3.2 Quick change coupling (AR-1641)... 12 1.4.3.3 BEACH CHAIR Sterile set (AR-1644)... 12 2 Safety notes 2.1 General safety notes... 13-15 3 Operation and use General... 16 3.1 Assembly... 17 3.2 3.2.1 Mounting TRIMANO on operating table... 18 3.2.2 Mounting the quick change coupling with sterile cover... 19-20 3.2.3 BEACH CHAIR Sterile set... 20 3.2.3.1 Mounting the BEACH CHAIR Sterile set... 20 3.2.3.2 PLACING PATIENT’S ARM... 21 3.2.3.3 SECURE PATIENT’S ARM... 21 3.3 Adjusting the retaining arm... 22 3.3.1 Removing the arm rest... 23 Disassembly... 24 3.4 3.4.1 Removing the quick change coupling... 24 3.4.2 Detaching TRIMANO... 25

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 3

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Table of Contents

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4 Cleaning and disinfection 4.1 General...26 4.1.1 Basic instructions...26-27 4.1.2 Stainless steel surfaces...27 4.1.3 Mechanical decontamination... 28 4.1.3.1 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...30 4.3.3 Disinfection procedure...30 4.4 Cleaning and disinfection procedures... 31 4.4.1 Manual cleaning, disinfection and sterilisation procedures... 31 4.4.2 Mechanical cleaning and disinfection procedures... 32 4.5 Disassembly of release handle... 32 4.6 Assembly of release handle... 33 4.7 After Cleaning/Disinfection/Sterilisation... 34 5 Inspections 5.1 Visual and functional inspections... 35 5.2 Maintenance...35 Repair...36 5.3 6 Technical specifications 6.1 Weight...37 6.2 Ambient conditions...37 7 Approved accessories 7.1 Approved accessories...37

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 4

Introduction Environmental Protection

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1 Introduction 1.1 Environmental protection 1.1.1 Packaging The packaging is made of materials compatible with the environment. Arthrex will dispose of the packaging materials upon request. 1.1.2 Arthrex products Arthrex will take back used products or those which are no longer in service. Please contact your Arthrex Distribution for more detailed information.

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1.1.3 Disposables Disposables must be handled and disposed of pursuant to national regulations. 1.2 How to use these operating instructions 1.2.1 General These operating instructions are provided to familiarize 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 responses The ”“ symbol identifies an action taken by the user while the ”“ symbol identifies the reaction that this will induce in the system. Example:  Turn on the light switch.  Lamp lights up.

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1

Introduction How to Use these Operating Instructions

1.2.3 Definitions 1.2.3.1 Design of safety notes Pictogram

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Descriptor

Text

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DANGER! Indicates a direct and immediate risk to persons, which may be fatal or result in most serious injury.

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DANGER! Indicates a potential risk to persons or property which may result in health hazard or grave property damage.

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DANGER! Indicates a potential risk to property which may result in property damage.

The text for the safety note describes the type of risk and how to avert it.

Fig. 1: Design of safety notes

1.2.3.2 Design of other notes Pictogram

Descriptor

Text

NOTE

Fig. 2: Design of other notes

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 6

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

Introduction How to Use these Operating Instructions

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1.2.4 Symbols used Pictogram

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

0123 134 °C

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”.

2

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

LOT

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

Packaging label. Symbol for “Keep dry”.

SN REF 2

STERILIZE

Fig. 3: Symbols (Part 1 of 2)

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”.

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1

Introduction How to Use these Operating Instructions

Pictogram

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

STERILE EO

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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”.

Fig. 3: Symbols (Part 2 of 2)

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 8

Introduction Pictorial Guide

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1.3 Pictorial guide 1.3.1 Pictorial view of TRIMANO

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Fig. 4: Pictorial view of TRIMANO

1 TRIMANO Support arm (AR-1640) 2 Release handle 3 Quick change coupling (AR-1641)

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 9

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Introduction Pictorial Guide

1.3.2 Overview Sterile set (AR-1644)

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

1 Cover 2 Self adherent wrap 3 Beach Chair arm holder

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 10

Introduction Basic Requirements

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1.4 Basic requirements 1.4.1 Use in accordance with the intended purpose This product is a Class I medical device according to the Medical Device Directive 93/42/EEC. This product is to be used exclusively in human medicine. Patients may be placed on the device and put in position only under the supervision of medical personnel. 1.4.2 Applicable standards The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted by the Medical Products Council (Medical Device Directive) as well as the applicable national codes and the Medical Products Act in Germany. This is certified by compliance with harmonised standards such as IEC 60601-1 and related standards and the respective special sections.

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Accessories Accessories or combinations of accessories may be utilised only when and as indicated in these operating instructions. Use other accessories, combinations and parts subject to wear only if these are intended expressly for the application and will not adversely affect performance features or safety requirements.

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Introduction Basic Requirements

1.4.3 Intended purposes

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1.4.3.1 TRIMANO (AR-1640) TRIMANO (AR-1640) is used, in combination with specific accessories, to accommodate a patient‘s arm immediately before, during and after surgical interventions as well as for examination and treatment. TRIMANO is mounted to the accessory rail of operating tables and can be fixed freely in various positions. The fixing may be manually released quickly (one-handed operation). After adjusting and releasing the operating element, the retaining arm is independently locked in the new position. Depending on the application, ensure sterility. TRIMANO may only be used in conjunction with 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) is used as intermediate element designed to couple the 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

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Safety Notes General Safety Notes

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2 Safety notes 2.1 General safety notes

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DANGER! Potentially fatal! Hazard resulting from improper handling. Be absolutely sure to follow the operating instructions for your mobile operating table or operating table system.

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DANGER! Potentially fatal! Vital functions can be impaired through incorrect positioning. Position the patient correctly and maintain continuous observation.

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WARNING! Risk of injury! Improper positioning can be detrimental to patient health. Always position the patient correctly and maintain continuous observation.

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

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WARNING! Risk of injury due to material failure! The maximum load for this product is its share of the load imposed by a patient weighing 180 kg.

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DANGER! Potentially fatal! The maximum load placed on the product may not exceed the appropriate proportion of a patient weighing 180 kg. Restrictions result from the permissible overall load, among other things, of accessory rails when using operating tables with a low maximum load capacity. Be absolutely sure to follow the operating instructions for your mobile operating table or operating table system.

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WARNING! 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 Notes General Safety Notes

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WARNING! 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 written permission from Arthrex.

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WARNING! Risk of injury! Collisions between accessories, the operating table, the table top and the patient can occur when adjusting or moving the operating table or table top or when transferring the table top. Observe the adjustment procedure and avoid collisions.

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

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WARNING! 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. Check locking after every adjustment procedure.

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WARNING! Risk of injury! If locking elements (offset levers, handle screws, locking mechanisms etc.) are opened, the clamps are released and the product can be moved. Before opening the locking elements, hold the individual parts securely. Make sure that all locking elements are closed after each adjustment procedure.

WARNING! Risk of injury! Whenever the product is mounted and adjusted, there is a danger of pinching and shearing 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.

!

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 14

Safety Notes General Safety Notes

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WARNING! 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 mobile operating table.

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WARNING! Risk of injury! During the adjustment procedures, the operating table / accessories may collide with accessories or downward pointing parts and thus may cause property damage 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.

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CAUTION! Property damage! The joints of the retaining arm may not be lubricated or oiled. It may lead to irreparable damage to the functioning of the unit.

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DANGER! Risk of infection! Do not use the sterile set when the packaging of the sterile set is damaged.

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3

Operation and Use General

3 Operation and use 3.1 General

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WARNING! Risk of infection! If the retaining arm is used in areas with varying hygienic requirements, there is a risk 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 accordance with the hygiene guideline and the instructions given in the chapter “Cleaning and disinfection“.

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CAUTION! Property damage! TRIMANO may only be used with accessories designed specifically for this purpose. Do not mount any other accessories onTRIMANO.

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CAUTION! 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.

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CAUTION! Property damage! During surgery, TRIMANO must be covered by a sterile cover to protect it against liquids.

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CAUTION! 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 designed for impulse loads.

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 16

Operation and Use Assembly

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3.2 Assembly NOTE The 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. NOTE All of the products used, except the retaining arm, which is used with a sterile cover, may only be used in sterile condition! The quick change coupling is supplied in a non-sterile condition and must be cleaned and sterilized before the first use.

1 Mounting position Position for mounting/detaching the retaining arm. 2 Neutral position Position for mounting the sterile cover. Adjusting the retaining arm (>>Page 22).

Fig. 6: Mounting position/neutral position

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 17

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Operation and Use Assembly

3.2.1 Mounting TRIMANO on operating table

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CAUTION! 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 retaining arm directly to the accessory rail of the operating table. WARNING! Risk of injury resulting from collision! During transport of the positioned patient with mounted retaining arm, position the retaining arm close to the body. NOTE Mount 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.

Fig. 7: Mounting TRIMANO

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 18

Operation and Use Assembly

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3.2.2 Mounting the quick change coupling with sterile cover NOTE After mounting the sterile cover, check to ensure full and sterile coverage of nonsterile areas.

Sticking the sterile cover to the quick change 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.

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

Mounting the quick change coupling The structure of both sides of the quick change coupling is identical and can be mounted on the retaining 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. 9: Mounting the quick change coupling

Operating Instructions TRIMANO AR-1640 LM0205, Vers. 1 19

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Operation and Use Assembly

Applying the sterile cover Requirement: 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.

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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.

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

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