Inhaltsverzeichnis; Applicable To; General Information; Intended Use - B. Braun Aesculap Acculan 4 GA331 Gebrauchsanweisung/Technische Beschreibung

Contents
1. Applicable to. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Main functions and design characteristics . . . . . . . . . . . . . . . . 3
2.3 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Absolute contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.5 Relative contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Scope of supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.2 Components required for operation . . . . . . . . . . . . . . . . . . . . . . 4
4.3 Operating principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6. Working with the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1 System set-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.1 Connecting the accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.2 Inserting the rechargeable battery . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.3 Intraoperative battery change. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1.4 Removing the rechargeable battery . . . . . . . . . . . . . . . . . . . . . . 6
6.1.5 Protection against inadvertent activation . . . . . . . . . . . . . . . . . 6
6.1.6 Attaching and detaching the saw blade. . . . . . . . . . . . . . . . . . . 6
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.1 Operating the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.3 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.4 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.6 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . . 9
7.7 Automatic cleaning/disinfection with manual pre-cleaning . . 10
7.7.1 Manual pre-cleaning with a brush . . . . . . . . . . . . . . . . . . . . . . . 10
7.7.2 Mechanical alkaline cleaning and thermal disinfection . . . . . . 11
7.8 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 11
7.9 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.10 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.11 Sterilization for the US market . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.12 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8. Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
11. Accessories/Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
12. Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.1 Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 15
12.2 Performance data, information about standards . . . . . . . . . . . 15
12.3 Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.4 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
14. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.

Applicable to

►
For item-specific instructions for use and information on material
compatibility, see
https://extranet.bbraun.com
2.

General information

2.1

Intended use

Task/Function
The oscillating saw GA331, combined with the relevant tool, is used for
processing hard tissue, cartilage and the like, as well as for bone replace-
ment materials.
Application Environment
The product fulfills the requirements for type BF pursuant to
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-
sia gases).
2.2

Main functions and design characteristics

Oscillation frequency
min. 0 min
Operating mode Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
■
■
■
■
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.
also the Aesculap
-1 to max. 13 000 min
30 second application, 30 second pause
7 repetitions
30 min cooling time
Max. Temperature 48 °C
Extranet at
-1
3