TRIMANO FORTIS adapter Instructions for Use

Copyright notice All rights reserved. Any duplication, adaptation or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. © Copyright MAQUET GmbH

Subject to technical modification! Due to further development of the product, the figures used and technical specifications given in these Instructions for Use may slightly differ from the current state of the product.

V06 07 04-09-2019

AR-1741 IFU AR-1741 EN 06

Contents

Contents 1

Introduction ...

5

1.1

How to use these operating instructions... 1.1.1 Abbreviations ... 1.1.2 Symbols and formatting ... 1.1.2.1 Sterile processes... 1.1.3 Definitions ... 1.1.3.1 Design of safety notes... 1.1.3.2 Structure of notes ... 1.1.3.3 Definition of maximum permitted weight load...

5 5 5 6 7 7 7 7

1.2

Graphical symbols used ...

8

1.3

Disposal ... 1.3.1 Old products... 1.3.2 Packaging ... 1.3.3 Disposable product ...

11 11 11 11

1.4

Overview... 1.4.1 TRIMANO FORTIS adapter (AR-1741) ... 1.4.2 Accessories for TRIMANO FORTIS adapter ... 1.4.3 Sterile sets / Sterile drapes ... 1.4.3.1 Sterile sets/drapes for the shoulder... 1.4.3.2 Sterile sets/drapes for the elbow ...

12 12 12 13 13 13

1.5

Basic requirements ... 1.5.1 Use in accordance with the intended purpose ... 1.5.2 Applicable standards... 1.5.3 Intended purpose ... 1.5.4 Mounting Points ... 1.5.5 Variants... 1.5.6 Product features... 1.5.6.1 Key performance characteristics ... 1.5.6.2 Latex-free materials... 1.5.7 Reportable event...

14 14 14 14 14 14 15 15 15 15

2

Safety notes... 16

2.1

General safety notes ...

16

2.2

Safety notes for the product ...

17

2.3

Safety notes regarding the use of accessories...

19

3

Mounting ... 20

3.1

General ...

20

3.2

Mounting the TRIMANO to the OR table ...

20

3.3

Mounting / removing the TRIMANO adapter with sterile sheath ...

21

4

Disassembly ... 24

4.1

Removing the TRIMANO adapter from the TRIMANO support arm...

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Contents

5

Operation and use... 25

5.1

General ...

5.2

Mounting accessories to/removing accessories from the TRIMANO adapter ... 26 5.2.1 Mounting the BEACH CHAIR arm rest to the TRIMANO... 26 5.2.2 Removing the BEACH CHAIR arm rest from the TRIMANO ... 27

6

Preparation ... 29

6.1

General information ...

29

6.2

Cleaning agents and disinfectants... 6.2.1 Suitable cleaning agents... 6.2.2 Suitable disinfectants ... 6.2.3 Non-usable products / substances...

31 31 31 32

6.3

Reconditioning procedure... 6.3.1 Manual pre-cleaning and disinfection ... 6.3.1.1 Pre-clean the product ... 6.3.1.2 Disinfect the product... 6.3.1.3 Inspections ... 6.3.2 Mechanical cleaning and disinfection ... 6.3.2.1 Prepare the product mechanically... 6.3.2.2 Disinfect the product... 6.3.2.3 Inspections ... 6.3.3 Sterilisation ... 6.3.4 Oiling the release buttons ...

33 34 34 34 34 35 35 35 35 36 37

7

Maintenance ... 38

7.1

Visual and functional inspections ...

38

7.2

Maintenance ...

39

7.3

Repair ...

39

7.4

Contact ...

39

7.5

Type plate ...

40

8

Technical specifications... 41

8.1

Ambient conditions ...

41

8.2

Dimensions ...

41

8.3

Weight ...

41

9

Approved accessories... 42

9.1

Table structure...

42

9.2

Accessories for TRIMANO FORTIS system ...

42

9.3

Sterile sets/drapes for the TRIMANO FORTIS system ...

43

25

Index... 44

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AR-1741 IFU AR-1741 EN 06

Introduction How to use these operating instructions

1

Introduction

1.1

How to use these operating instructions

1

These operating instructions are provided to familiarise you with the features of this product. The operating instructions are divided into separate chapters. Please note: • Read these operating instructions through carefully and completely before using the product for the first time. • Always proceed in accordance with the information provided in these operating instructions. • Store these operating instructions in the vicinity of the product.

1.1.1

Abbreviations EN IEC ISO SFC SN

1.1.2

European standard International Electrotechnical Commission International Organization for Standardization Soft Foam Core (special foam core) Serial no.

Symbols and formatting Symbol

Meaning

1. 2.

Instructions to follow / list with numbered steps Result of an action

●

Numbered steps / List entry / precondition Reference to other pages within this document

[...]

Key / Module / Mode

bold

Menu / on-screen button

[italics]

Field to be filled in

1122.33XX

Order number with different variants (XX)

Tab. 1:

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Symbols and formatting

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1 1.1.2.1

Introduction How to use these operating instructions

Sterile processes The "S" in graphics identifies an act carried out by the user that must be executed under sterile conditions.

Fig. 1:

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Example for the labelling of a sterile process

AR-1741 IFU AR-1741 EN 06

Introduction

1

How to use these operating instructions

1.1.3

Definitions

1.1.3.1

Design of safety notes Pictogram

Tab. 2:

1.1.3.2

Text

DANGER!

Identifies an immediate danger to people, which may result in death or serious injuries.

WARNING!

Identifies a potential danger to people or property, which may result in damage to health or serious property damages.

CAUTION!

Identifies a potential danger to property, which may result in property damages.

Design of safety notes

Structure of notes Pictogram

Tab. 3:

1.1.3.3

Descriptor

Descriptor

Text

NOTE

Supplementary assistance or further useful information which does not indicate a risk of injury to persons or a risk of property damage are described in the text of the note.

Structure of notes

Definition of maximum permitted weight load The maximum permitted weight load is calculated using the proportional load of the weight of the patient, plus the additional load posed by side rail accessories, mounted accessories and/or OR personnel.

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1 1.2

Introduction Graphical symbols used

Graphical symbols used Symbols are attached to products, type plates and packaging. Symbols

Labelling Labelling of products developed and marketed in accordance with relevant European legal provisions.

Labelling in accordance with the standard ISO 15223-1. Symbol for "Name and address of the manufacturer". The date of manufacturing can be combined with this symbol. Labelling in accordance with the ISO 15223-1 standard. Symbol for "Serial number".

Labelling in accordance with the standard ISO 15223-1. Symbol for "Catalogue number / product number".

Symbol for the labelling of medical devices

Marking according to the standard ISO 15223-1. Symbol for "Name of batch".

Labelling in accordance with the ISO 15223-1 standard. Symbol for “Usable until”.

Labelling in accordance with the ISO 15223-1 standard. Symbol for “Do not use if packaging is damaged”.

Labelling in accordance with the ISO 15223-1 standard. Symbol for "Not for re-use".

Labelling in accordance with the ISO 15223-1 standard. Symbol for “Do not re-sterilize”.

Tab. 4:

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Symbols

AR-1741 IFU AR-1741 EN 06

Introduction Graphical symbols used

Symbols

1

Labelling Labelling in accordance with the standard ISO 15223-1. Symbol for “Sterilisation with ethylene oxide”.

Labelling in accordance with the ISO 15223-1 standard. Symbol for "Store protected from sunlight".

Labelling in accordance with the IEC 60601-1 standard. Symbol for "Follow Instructions for use".

Labelling in accordance with the ISO 15223-1 standard. Symbol für "Consult instructions for use".

Label for products that can be sterilised at up to 134 °C.

Labelling in accordance with the ISO 15223-1 standard. Symbol for "Latex-free".

Labelling in accordance with the ISO 15223-1 standard. Labelling of packaging materials. Symbol for "Keep dry". Labelling in accordance with the ISO 15223-1 standard. Symbol for "Fragile! Handle with care".

Labelling in accordance with the ISO 7000 standard. Symbol for "Top".

Labelling in accordance with the ISO 15223-1 standard. Symbol for "Temperature limit".

Tab. 4:

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Symbols

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1

Introduction Graphical symbols used

Symbols

Labelling Labelling in accordance with the ISO 15223-1 standard. Symbol for "Humidity limitation".

Labelling in accordance with the ISO 15223-1 standard. Symbol for "Atmospheric pressure limitation".

Tab. 4:

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Symbols

AR-1741 IFU AR-1741 EN 06

Introduction Disposal

1.3

Disposal

1.3.1

Old products

1

Arthrex will take back used products or those which are no longer in service. For further information, please contact your personal Arthrex representative. Used products or parts thereof may be contaminated. In order to prevent a potential infection, the product must be cleaned and disinfected prior to its return/disposal. The national regulations and disposal regulations must be observed for all disposal measures.

1.3.2

Packaging Packaging materials are made up of environmentally friendly materials and can be disposed of via the household waste in accordance with national requirements.

1.3.3

Disposable product Disposable products must be handled and disposed of pursuant to national regulations.

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1

Introduction Overview

1.4

Overview

1.4.1

TRIMANO FORTIS adapter (AR-1741)

3

1

TRIMANO FORTIS Adapter

2

Lower release buttons

3

Upper release buttons

1

2 Fig. 2:

1.4.2

TRIMANO FORTIS Adapter

Accessories for TRIMANO FORTIS adapter Accessories are not supplied and must be ordered separately. Please observe the instructions for use of the accessories!

3

1

2

Fig. 3:

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Accessories for TRIMANO FORTIS adapter

1

TRIMANO Wrist Positioner (AR-1647)

2

TRIMANO Synergy UHD4 Camera Head Holder (AR-3210-0011) / TRIMANO Synergy Camera Head Holder (AR-3210-0010)

3

TRIMANO Drape for Wrist Positioner or Camera Head Holder (AR-1648)

AR-1741 IFU AR-1741 EN 06

Introduction Overview

1.4.3

Sterile sets / Sterile drapes

1.4.3.1

Sterile sets/drapes for the shoulder

1

1

3 2

Fig. 4:

1.4.3.2

Arthrex TRIMANO Beach Chair-Kit (AR-1644)

1

TRIMANO Drape

2

Long stretch strap

3

Disposable arm rest

Sterile sets/drapes for the elbow

1

2

Fig. 5: 1

AR-1741 IFU AR-1741 EN 06

Arthrex TRIMANO Elbow Kit (AR-1646)

Disposable elbow rest

2

Drape for elbow kit (supplied)

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1

Introduction Basic requirements

1.5

Basic requirements

1.5.1

Use in accordance with the intended purpose This product is a medical device. The product is designed solely for the purpose of human medicine. The patient may only be placed and positioned under medical supervision. Accessories Accessories or combinations of accessories may only be used as and when indicated in these instructions for use. Other accessories, combinations of accessories or consumables may only be used if they are designed specifically for the use in question and will not adversely affect either performance features or safety requirements.

1.5.2

Applicable standards The product meets the basic safety and performance requirements in accordance with the local applicable legal specifications for medical devices.

1.5.3

Intended purpose The TRIMANO FORTIS Adapter (AR-1741 / 1002.31R0) is designed for placement and positioning of the patient's arm / patient's leg / patient's hand in conjunction with Trimano Fortis (AR-1740 / 1002.30R0) and specific accessories for the TRIMANO system or for attaching other products directly before, during, and after surgical interventions as well as for examination and treatment. Depending on the specific accessories used, the TRIMANO FORTIS Adapter may only be used along with the sterile covers (AR-1648 / 1002.53F0). The maximum load that may be placed on the product is 21kg. This corresponds to a proportional arm weight of a 250kg patient. This furthermore corresponds to a proportional leg weight of a 180kg patient. The product may only be operated by medically trained staff within the OR environment. The product may only be used by personnel with the appropriate training. Any use other than those described above is deemed not to be in compliance with the intended purpose. In the following section, the TRIMANO FORTIS adapter is simply referred to as the TRIMANO adapter, and the TRIMANO FORTIS 3D support arm is also simply referred to as TRIMANO.

1.5.4

Mounting Points The TRIMANO FORTIS adapter may be mounted to the following products: • TRIMANO FORTIS Arthrex 3D support arm (1002.30R0 / AR-1740)

1.5.5

Variants The product is available in the following versions: • AR-1741 / 1002.31R0 Arthrex adapter for TRIMANO FORTIS

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AR-1741 IFU AR-1741 EN 06

Introduction Basic requirements

1.5.6

Product features

1.5.6.1

Key performance characteristics

1

The product corresponds to IEC 60601-1 and its collateral standards with the following key performance characteristics: • Placement of the patient (or the patient’s body parts) without unwanted movement in case of an initial error. 1.5.6.2

Latex-free materials All used materials (e.g. materials for pads and straps) are latex free.

1.5.7

Reportable event Any serious incident involving this product must be reported to MAQUET GmbH and, if necessary, to the local competent authority.

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2

Safety notes General safety notes

2

Safety notes

2.1

General safety notes DA NG ER ! Potentially fatal! Risk caused by unauthorised modifications. Modifications at the product are not permitted.

DA NG ER ! Potentially fatal! Danger resulting from improper handling. Always observe the instructions for use for the OR table.

DA NG ER ! Potentially fatal! Risk posed to the patient's vital functions due to incorrect positioning. Position the patient correctly and keep under permanent observation.

WARN IN G ! Risk of injury! Improper patient positioning may cause health damage (e. g. decubitus). Position the patient correctly and keep under constant observation.

WARN IN G ! Risk of injury! Faulty or defective products may result in injuries. • Before use, check the proper working order and fully functional state of the product. • Stop using faulty or defective products.

WARN IN G ! Risk of injury! When adjusting and moving the OR table, the transporter, the table top or the accessories, as well as when carrying out a table top transfer, collisions may occur between the patient and individual products or parts that are pointing downwards. During adjustments, observe the OR table, the transporter, the table top and accessories constantly and avoid collisions. Ensure that tubes, cables and drapes are not trapped.

WARN IN G ! Risk of burns! The use of high-frequency devices, defibrillators and defibrillator monitors exposes the patient to burn risks due to contact with the metal components in the product or accessories and/or as a result of resting on wet drapes or electrically conductive padding. Avoid any contact between the patient and metal components; never use damp or wet surgical drapes. Be absolutely sure to comply with the manufacturers instructions for use!

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AR-1741 IFU AR-1741 EN 06

Safety notes Safety notes for the product

2

WARN ING ! Risk of injury! Products / accessories not attached properly may loosen and cause injuries. Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured.

WARN ING ! Risk of injury! If locking elements (eccentric levers, handle screws, locks etc.) are open, the product/accessory can be moved. Before opening the locking elements, hold the individual items firmly. After every adjustment procedure, ensure that all locking elements are closed.

WARN ING ! Risk of injury! When adjusting, moving or storing the OR table / table top, the staff, the patient and the accessories are exposed to pinching and shearing hazards, particularly in the area around the joints at the head rest, back and leg plates. 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.

2.2

Safety notes for the product WARN ING ! Risk of injury due to material failure! The maximum load that may be placed on the product is 21 kg.

WARN ING ! Risk of injury due to overloading! The permitted load of the product depends on the combination of accessories used. The product with the lowest permissible load determines the maximum load in the event that it is combined with other accessories. Refer to the instructions for use of each accessory for the permissible load.

DA NG ER ! Risk of explosion! The product has no explosion protection and is not suitable for use in AP-M areas prone to explosion. When using disinfectants that contain alcohol, cleaning agents or flammable anaesthesia mixtures that are mixed with air, oxygen or nitrous oxide, explosions may result. If the product is used in an AP-M area, do not use disinfectants that contain alcohol, cleaning agents or flammable anaesthesia mixtures that are mixed with air, oxygen or nitrous oxide.

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2

Safety notes Safety notes for the product

DA NG ER ! Hazard of infection! If the packaging of the sterile parts set is damaged the set is no longer permitted to be used.

WARN IN G ! Risk of injury! If the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner. Always secure the patient using suitable aids (e.g. straps) and maintain continuous observation.

WARN IN G ! 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.

WARN IN G ! Risk of injury! Loose or loosened securing elements may cause injuries. When mounting, and after every adjustment, tighten all of the locking elements (handle screw, locks, levers, etc.) of the product. Check the firm seating of the locking elements.

WARN IN G ! Risk of OR table tipping! The product influences the centre of gravity of mobile operating tables and mobile/independently manoeuvrable columns of operating table systems. When positioning the patient, observe the instructions for use of the operating table used.

CA UTIO N ! Property damage! The product may only be used with accessories designed specifically for this purpose. Do not mount any other accessories to the product.

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Safety notes Safety notes regarding the use of accessories

2.3

2

Safety notes regarding the use of accessories DA NG ER ! Potentially fatal! Patient may be endangered as a result of incorrect use. Follow the instructions for use for all accessories.

WARN ING ! Risk of injury! Accessories not approved for this product and accessories by other manufacturers may cause injuries. Only use accessories that have been approved for use with the product. Accessories made by other manufacturers may only be used after obtaining written permission.

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3

Mounting General

3

Mounting

3.1

General NO TE Always observe the usage notes for the sterile set as included in the instructions for use of the TRIMANO support arm.

3.2

Mounting the TRIMANO to the OR table WARN IN G ! Risk of injury resulting from collision! Position the mounted TRIMANO close to the body when transporting a positioned patient.

CA UTIO N ! Property damage! The clamp of the TRIMANO may be damaged when removing the patient cover. Do not attach the TRIMANO to a patient cover. Mount the TRIMANO directly to the side rail of the OR table.

NO TE For applications on arm and shoulder, attach the TRIMANO in the vicinity of the seat plate between hip and knee.

1. Put TRIMANO in the mounting position. 2. Fully unscrew the fixation screw 1 of the clamp 2 .

2

3. Place the clamp on the side rail. Ø The fixation screw points upwards. 1

4. Tighten the fixation screw. Ø The TRIMANO is adapted to the side rail of the OR table. 5. Check proper seating.

Fig. 6:

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Mounting TRIMANO

AR-1741 IFU AR-1741 EN 06