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Contents
1.
About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1
Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2
Main functions and design characteristics . . . . . . . . . . . . . . . .
2.3
Application environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5
Absolute contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.6
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
Protection against inadvertent activation . . . . . . . . . . . . . . . . .
6.1.3
Attaching and removing product attachments . . . . . . . . . . . . .
6.2
Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3
Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.1
Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.2
Oscillating operation or thread cutting operation . . . . . . . . . .
7.
Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . .
7.1
General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3
Reusable products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.4
Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . .
7.5
Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6
Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6.1
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.7
Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . .
7.8
7.8.1
Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . . 10
7.8.2
Mechanical alkaline cleaning and thermal disinfection . . . . . . 11
7.9
Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 11
7.10
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.11
Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.12
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
8.
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9.
Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.
Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11.
Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12.
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12.1
Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 12
12.2
Performance data, information about standards . . . . . . . . . . . 12
12.3
Short-time interval operation. . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12.4
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
13.
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.
About this document
3
Note
3
General risks of surgical intervention are not described in these instructions
for use.
3
3
1.1
Scope
3
These instructions for use apply to the ELAN 4 electro drill tool GA844.
4
►
For article specific instructions for use and material compatibility and
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lifetime information, see B. BrauneIFU at eifu.bbraun.com
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4
1.2
Warnings
4
Warnings indicate risks to patients, users, and/or products which may
4
develop during the use of the product. Warnings are marked as follows:
5
5
DANGER
5
Indicates a potential danger. If it is not prevented, death or severe
5
injuries may result.
5
5
WARNING
5
Indicates a potential danger. If it is not prevented, minor or moderate
injuries may result.
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6
CAUTION
6
Indicates a potential damage to property. If it is not prevented, the
6
product may be damaged.
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7
2.
General information
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7
2.1
Intended use
7
Task/Function
7
The ELAN 4 electro drill GA844 is an accessory of the ELAN 4 electro motor
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system.
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The drill is connected to the control unit.
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The ELAN 4 electro drill GA844, combined with the corresponding attach-
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ment and tool, is used for processing hard tissue, cartilage and the like, as
well as bone replacement material, to screw bone pins in and out, to drive
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screw tools and to set transfixion wires.
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en
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