Tabla De Contenido; About This Document; Scope; Warnings - Aesculap Acculan 4 GA334 Instrucciones De Manejo

Contents
1. About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Main functions and design characteristics . . . . . . . . . . . . . . . .
2.2.1 Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4 Absolute contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5 Relative contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Scope of supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Components required for operation . . . . . . . . . . . . . . . . . . . . . .
4.3 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5. Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. Working with the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1.1 Connecting the accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1.2 Inserting the rechargeable battery. . . . . . . . . . . . . . . . . . . . . . .
6.1.3 Intraoperative battery change . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1.4 Removing the rechargeable battery . . . . . . . . . . . . . . . . . . . . . .
6.1.5 Protection against inadvertent activation . . . . . . . . . . . . . . . . .
6.1.6 Attaching and detaching the saw blade . . . . . . . . . . . . . . . . . .
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.1 Operating the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . .
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3 Reusable products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.4 Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . .
7.5 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6 Product-specific safety instructions for the processing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.7 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . .
7.8 Automatic cleaning/disinfection with manual pre-cleaning . .
7.8.1 Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . .
7.8.2 Mechanical alkaline cleaning and thermal disinfection . . . . . .
7.9 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 10
7.10 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.11 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.12 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
12. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
12.1 Classification according to Regulation (EU) 2017/745. . . . . . . 13
12.2 Performance data, information about standards . . . . . . . . . . . 13
12.3 Nominal operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
12.4 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.

About this document

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1.1

Scope

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These instructions for use apply to the products listed below:
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Art. no. Name
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GA334 Reciprocating saw
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►
For instructions for use of specific items and information on material
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compatibility, see B. Braun eIFU at eifu.bbraun.com
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1.2

Warnings

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Warnings indicate risks to patients, users, and/or the product that could
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develop while using the product. Warnings are marked as follows:
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DANGER
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Indicates a potential danger. If it is not prevented, death or severe
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injuries may result.
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WARNING
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Indicates a potential danger. Minor or moderate injuries may result if
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this is not prevented.
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CAUTION
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Indicates a potential damage to property. The product may become
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damaged if it is not prevented.
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2.

General information

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2.1

Intended use

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Task/Function
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When combined with the appropriate tool, and where required with the
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corresponding protection guide, the Reciprocating saw GA334 is used to
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work on hard tissue, cartilage and related materials, as well as bone
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replacement materials.
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Application Environment
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The product fulfills the requirements for type BF pursuant to
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IEC/DIN EN 60601-1 and is used in operating rooms in sterile environ-
ments of explosion risk areas (such as areas with pure oxygen or anesthe-
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sia gases).
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2.2

Main functions and design characteristics

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Oscillation frequency
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2.2.1

Operating mode

Operation with non-periodic load and speed changes (type S9 pursuant to
IEC EN 60034-1)
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30 second application, 30 second pause
■
5 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Electrical systems generally heat up during continual operation. It is
advised to give the system a break after use to cool down, as listed in the
table on operating mode.
Heating depends on the tool used and the load. After a certain number of
repetitions, the system should cool down. This procedure prevents the sys-
tem overheating as well as possible injury to the patient or user.
The user is responsible for the use and adherence to the pause sequence
described.
min. 0 rpm to max. 15 000 rpm
en
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