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7.10 Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.11 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.12 Sterilization for the US market . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.13 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8.
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.
Technical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
11.
Accessories/Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
12.
Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
12.1 Classification acc. to Directive 93/42/EEC . . . . . . . . . . . . . . . . . 16
12.2 Performance data, information about standards . . . . . . . . . . . . 16
12.3 Tool speed/Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12.4 Short interval operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12.5 Ambient conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
13.
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
14.
Distributor in the US/Contact in Canada for product
information and complaints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.
Applicable to
►
For item-specific instructions for use and information on material
compatibility,
see
https://extranet.bbraun.com
2.
Intended use
2.1
Task/function within system
The handheld Highspeed ELAN 4 electro Standard handpiece (1 ring)
GA861 to GA864 or ELAN 4 electro HD handpiece (2 ring) GA865 to
GA869 is an accessory of the ELAN 4 electro motor system.
The handpiece is connected by an ELAN 4 electro motor cable to the con-
trol unit.
The handpiece is used to drive Aesculap ELAN 4 tools (1 ring or 2 ring).
Speed
min. 0 rpm to max. 80 000 rpm
Rotational direction
Right and left rotation
Short interval operation
30 second application, 30 second pause
at 60 000 RPM
2.2
Application Environment
Application in the sterile area
also
the
Aesculap
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.
Note
The clinical success of the use of the ELAN 4 electro motor system is depen-
dent on the knowledge and experience of the surgeon. The surgeon must
Extranet
at
decide which structures it is sensible to treat and take into account the
safety and warning information contained in these instructions for use.
Separating, removing and shaping hard tis-
sue, cartilage and similar, as well as for drill-
ing holes in bone and bone replacement
materials.
Neurosurgery, ENT surgery, OMF surgery,
orthopedics and trauma surgery
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