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Contents
1.
Applicable to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2
Main functions and design characteristics . . . . . . . . . . . . . . . .
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
Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . .
7.4
Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.5
Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.5.1
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6
Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . .
7.7
7.7.1
Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . .
7.7.2
7.8
Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 10
7.9
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.10
Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.11
Sterilization for the US market. . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.12
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8.
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9.
Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.
Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11.
Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12.
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
12.1
Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 13
12.2
Performance data, information about standards . . . . . . . . . . . 13
12.3
Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
12.4
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
13.
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
14.
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.
Applicable to
►
3
For item-specific instructions for use and information on material
compatibility,
see
3
https://extranet.bbraun.com
3
3
2.
General information
3
3
2.1
Intended use
3
Task/Function
4
The oscillating saw GA331, combined with the relevant tool, is used for
4
processing hard tissue, cartilage and the like, as well as for bone replace-
4
ment materials.
4
Application Environment
4
The product fulfills the requirements for type BF pursuant to
4
IEC/DIN EN 60601-1 and is used in operating rooms in sterile environ-
5
ments of explosion risk areas (such as areas with pure oxygen or anesthe-
5
sia gases).
5
2.2
Main functions and design characteristics
5
5
Oscillation frequency
5
Operating mode
6
6
6
6
6
7
7
7
7
Electrical systems generally heat up during continual operation. It is
7
advised to give the system a break after use to cool down, as listed in the
7
table on operating mode.
Heating depends on the tool used and the load. After a certain number of
7
repetitions, the system should cool down. This procedure prevents the sys-
8
tem overheating as well as possible injury to the patient or user.
9
The user is responsible for the use and adherence to the pause sequence
described.
9
9
2.3
Indications
The type and area of application depend on the tool selected.
2.4
Absolute contraindications
The product is not licensed for use on the central nervous system or central
circulatory system.
2.5
Relative contraindications
The safe and effective use of the product greatly depends on influences
which can only be controlled by the user. Therefore the specifications pro-
vided represent framework conditions only.
Clinically successful use of the product is dependent on the knowledge and
experience of the surgeon. The surgeon must decide which structures it is
sensible to treat and take into account the safety and warning information
contained in these instructions for use.
also
the
Aesculap
-1
min. 0 min
to max. 13 000 min
Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
■
30 second application, 30 second pause
■
7 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
en
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at
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