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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.
3.
Safe handling
WARNING
Risk of injury and material damage if this product is not used as
intended!
►
Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
►
Follow the instructions for use of all products used.
■
General risk factors associated with surgical procedures are not
described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both the
hands-on and conceptual aspects of the established operating tech-
niques.
►
Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►
Check the functionality and proper condition before using the product.
►
Observe "Guidance on Electromagnetic Compatibility (EMC) for
Acculan Components" TA022450, see B. Braun eIFU at eifu.bbraun.com
►
To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
Keep the instructions for use accessible for the user.
►
Comply with valid standards.
►
Ensure that the electrical installation of the room is consistent with the
requirements of IEC/DIN EN.
►
Do not operate the product in explosion-hazard areas.
►
Sterilize product before use.
►
When using ECCOS holder systems, observe relevant instructions for
use TA009721, see B. Braun eIFU at eifu.bbraun.com
Note
The user must report all serious incidents occurring in connection with the
product to the manufacturer and to the competent authority of the country
in which the user is registered.
4
4.
Product description
4.1
Scope of supply
Item no.
Designation
GA330
Drill tool and milling machine
GA672207
Kirschner wire protection sleeve
GA678
Sterile funnel
GA672211
Rinsing adapter
GB600840
Oil spray adapter
TA011944
Cleaning brush
TA014539
Instructions for use of the drill and reamer GA330
(flyer)
4.2
Components required for operation
■
NiMH battery long GA676 (charged)
■
Sterile funnel GA678
■
Lid GA675
■
Attachment (depending on indication)
■
Tool (depending on indication)
4.3
Operating principle
The product 1 contains an electric motor, which is powered by a replace-
able battery 7.
The charged non-sterile battery 7 is inserted into the product 1 via the
sterile funnel 6 and sealed with the lid 8 so that it is sterile.
The output speed is controlled electronically and can be continuously reg-
ulated with the knob for speed control 2.
The direction of rotation can be changed from right to left again using the
knob for left rotation 11. The product 1 can also be operated in an oscil-
lation mode.
The product 1 has a coupling on the output side, which allows for the
attachment of various drilling, milling and saw attachments. These attach-
ments lock automatically when attached to the product.
The attachment can be removed by operating a rotating sleeve 13. Reduc-
tion gearing in the various attachments reduce the motor speed and
enable operation of the motor at an ideal operating point.
The attachments have various integrated couplings on the working end, to
attach various tools, with adapter if necessary.
The product 1 is equipped with a cannulation to attach guide shafts or the
like.
5.
Preparation
Aesculap assumes no liability if the following rules are not followed:
►
Do not use products from open or damaged sterile packaging.
►
Prior to use, inspect the product and its accessories for any visible dam-
age.
►
Use the products and their accessories only if they are in perfect tech-
nical condition.
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