About This Document; Scope; Warnings; General Information - B.Braun Aesculap Acculan 4 GA330 Instrucciones De Manejo/Descripción Técnica

6.1.5 Protection against inadvertent activation . . . . . . . . . . . . . . . . .
6.1.6 Attaching and removing product attachments . . . . . . . . . . . . .
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.1 Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.2 Tapping Operation or Oscillating Operation . . . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
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

1.1

Scope

These instructions for use apply to the products listed below:
Item no. Name
GA330 Drill tool and milling machine
►
For instructions for use of specific items and information on material
compatibility, see B. Braun eIFU at eifu.bbraun.com
1.2

Warnings

Warnings indicate risks to patients, users, and/or the product that could
develop while using the product. Warnings are marked as follows:
DANGER
Indicates a potential danger. If it is not prevented, death or severe
injuries may result.
WARNING
Indicates a potential danger. Minor or moderate injuries may result if
this is not prevented.
CAUTION
Indicates a potential damage to property. The product may become
damaged if it is not prevented.
6 2.

General information

6
2.1

Intended use

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Task/Function
6
In combination with the appropriate attachment and tool, the Drill and
6
reamer GA330 is used to work on hard tissue, cartilage and related mate-
6
rials, as well as bone replacement materials, to screw bone pins in and out,
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and also to set K-wires.
7
Application Environment
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The product fulfills the requirements for type BF pursuant to
7
IEC/DIN EN 60601-1 and is used in operating rooms in sterile environ-
7
ments of explosion risk areas (such as areas with pure oxygen or anesthe-
7
sia gases).
2.2

Main functions and design characteristics

7
8
Speed
9
Rotational direction
9
9
2.2.1

Operating mode

Operation with non-periodic load and speed changes (type S9 pursuant to
IEC EN 60034-1)
Drilling (clockwise/counterclockwise rotation)
■
60 second application, 60 second pause
■
20 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Milling (clockwise/counterclockwise rotation)
■
30 second application, 30 second pause
■
8 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Drilling (oscillation)
■
60 second application, 60 second pause
■
4 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Saw operation using GB660R
■
30 second application, 60 second pause
■
3 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.
2.3

Indications

Type and area of application depend on the selected tool.
2.4

Absolute contraindications

The product is not approved for use in the central nervous system or cen-
tral circulatory system.
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min. 0 min to max. 26 000 min
Clockwise and counter-clockwise rotation,
oscillation
en
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3