3
en
7.
Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . .
7
7.1
General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
7.2
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
7.3
Reusable products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
7.4
Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . .
7
7.5
Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
7.6
Product-specific safety instructions for the processing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
7.7
Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . .
8
7.8
Automatic cleaning/disinfection with manual pre-cleaning . .
9
7.8.1
Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . .
9
7.8.2
Mechanical alkaline cleaning and thermal disinfection . . . . . . 10
7.9
Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 10
7.10
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.11
Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.12
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8.
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9.
Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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
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:
►
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.
2.
General information
2.1
Intended use
Task/Function
When combined with the appropriate tool, the Oscillating saw GA331, is
used to work on hard tissue, cartilage and related materials, as well as
bone replacement 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
2.2.1
Operating mode
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
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.
2.5
Relative contraindications
The safe and effective use of the product depends greatly on factors that
only operators themselves can control. The information provided therefore
only represents general conditions.
The clinically successful use of the product depends on the knowledge and
experience of the surgeon. They must decide which structures can be sen-
sibly treated and must take the safety information and warnings in the
instruction for use into account.
Art. no.
Name
GA331
Oscillating saw
Oscillation frequency
min. 0 min
-1
to max. 13 000 min
-1
