Braun Aesculap ELAN 4 Instructions For Use/Technical Description

3
USA
6.1.1 Connecting the accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.2 Protection against inadvertent activation. . . . . . . . . . . . . . . . . 5
6.1.3 Attaching and removing product attachments . . . . . . . . . . . . . 5
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.1 Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.2 Oscillating operation or thread cutting operation . . . . . . . . . . 6
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 6
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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 Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.6.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.7 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . . 8
7.8 Automatic cleaning/disinfection with manual pre-cleaning . . 8
7.8.1 Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . . 8
7.8.2 Mechanical alkaline cleaning and thermal disinfection. . . . . . 9
7.9 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 9
7.10 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.11 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.12 Sterilization for the US market. . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.13 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12.1 Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 10
12.2 Performance data, information about standards . . . . . . . . . . . 10
12.3 Short-time interval operation. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
12.4 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
14. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1. About this document
Note
General risks of surgical intervention are not described in these instructions
for use.
1.1 Scope
These instructions for use apply to the ELAN 4 electro drill tool GA844.
► For article specific instructions for use and material compatibility and
lifetime information, see B. Braun eIFU at eifu.bbraun.com
1.2 Warnings
Warnings indicate risks to patients, users, and/or products which may
develop during the use of 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. If it is not prevented, minor or moderate
injuries may result.
CAUTION
Indicates a potential damage to property. If it is not prevented, the
product may be damaged.
2. General information
2.1 Intended use
Task/Function
The ELAN 4 electro drill GA844 is an accessory of the ELAN 4 electro motor
system.
The drill is connected to the control unit.
The ELAN 4 electro drill GA844, combined with the corresponding attach-
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
screw tools and to set transfixion wires.
2.2 Main functions and design characteristics
Speed
min. 0 min
-1
to max. 1 250 min
-1
Rotational direction
Right and left rotation, oscillation
Short-time interval operation
Drilling (clockwise/counterclockwise rotation):
■ 60 second application, 60 second pause
■ 6 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
Medullary reaming (clockwise/anti-clockwise rotation):
■ 30 second application, 30 second pause
■ 8 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
Drilling (oscillation):
■ 15 s application, 15 s pause
■ 3 repetitions
■ 30 min cooling time
■ Max. temperature 48 °C
Saw operation with GB891R:
■ 30 second application, 60 second pause
■ 4 repetitions
■ 30 min cooling time
■ Max. temperature 48 °C
Saw operation with GB892R:
■ 30 second application, 60 second pause
■ 5 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
Screws with GB896R and GB897R:
■ 10 s machine application, 10 s manual application, 30 s pause
■ 30 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
Document No.: TA014436 - Version: 1.0 - Document ID: SOP-AIC-5002244 Date/Time Printed/Viewed: 2022-04-13 16:01 (CET)
Effective

Braun Aesculap ELAN 4 Specifications

General

Brand	Braun
Model	Aesculap ELAN 4
Category	Medical Equipment
Language	English