Contents
1.
Applicable to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1
Task/function within system . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2
Application Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.
Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1
Sterile ELAN 4 tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2
ELAN 4 single-use spray nozzle for sawing GA258SU . . . . . . . .
4.
Product description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1
Scope of supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2
Components required for operation . . . . . . . . . . . . . . . . . . . . . .
4.3
Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.
Working with the applied part. . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1
System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2
Function checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3
Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6
Manual cleaning with immersion disinfection - applied part . .
7.7
Mechanical cleaning/disinfecting with manual pre-cleaning -
applied part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.8
Mechanical cleaning/disinfecting with manual pre-cleaning -
tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.9
Inspection, maintenance and checks. . . . . . . . . . . . . . . . . . . . . . 13
7.10 Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.11 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.12 Sterilization for the US market . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.13 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
9.
Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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 Tool speed/Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.4 Short interval operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.5 Ambient conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
13.
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14.
Distributor in the US/Contact in Canada for product
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information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.
Applicable to
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►
For item-specific instructions for use and information on material
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compatibility,
see
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https://extranet.bbraun.com
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2.
Intended use
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2.1
Task/function within system
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The hand-held ELAN 4 electro micro sagittal saw GA836 is an accessory of
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the ELAN 4 electro motor system.
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The micro sagittal saw is connected by an ELAN 4 electro motor cable to
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the control unit.
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The micro sagittal saw is used to drive Aesculap micro sagittal saw blades.
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Speed
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Short interval operation
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2.2
Application Environment
Application in the sterile area
2.3
Indications
Modes of application
Surgical discipline/areas
of application
Note
The type and area of application depend on the tools selected.
2.4
Contraindications
The ELAN 4 electro motor system is not authorized for use in the central
nervous system or central circulatory system.
Note
The safe and effective use of electrically driven applied parts depends heav-
ily on influences that only the user can control him or herself. Therefore the
specifications provided represent framework conditions only.
also
the
Aesculap
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min. 0 min
to max. 20 000 min
30 second application, 60 second pause, 10
repetitions
Separating, removing, shaping and sawing
hard tissue and bone replacement materials.
Neurosurgery, ENT surgery, OMF surgery,
orthopedics and trauma surgery
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Extranet
at
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