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Contents
1.
Safe handling .................................................................................................. 3
2.
Product description ....................................................................................... 4
2.1 Components necessary for use .................................................................. 4
2.2 Intended use ................................................................................................... 4
2.2.1 Craniotomy ...................................................................................................... 4
2.2.2 Depth stop ....................................................................................................... 4
2.2.3 Holding sleeve................................................................................................. 4
2.3 Operating principle ....................................................................................... 4
3.
Preparation ...................................................................................................... 5
4.
or the depth stop and holding sleeve ...................................................... 5
4.1 System set-up ................................................................................................. 5
4.2 Connecting the accessories ........................................................................ 5
4.2.1 Coupling a tool ............................................................................................... 5
4.2.2 Uncoupling a tool .......................................................................................... 6
the craniotome handpiece .......................................................................... 6
holding sleeve on the craniotome handpiece........................................ 6
handpiece......................................................................................................... 6
4.4 Uncoupling of the dura protector/attachment ..................................... 6
4.4.1 Uncoupling the dura protector (fixed)/attachment ............................. 6
4.4.2 Uncoupling the dura protector (pivoted)................................................ 6
motor ................................................................................................................. 6
4.7 Connecting/Disconnecting the spray nozzle .......................................... 7
4.7.1 Connecting the spray nozzle ...................................................................... 7
4.7.2 Disconnecting the spray nozzle ................................................................. 7
4.8 Function checks ............................................................................................. 7
4.9 Safe operation ................................................................................................ 7
4.9.1 Operation for craniotomy............................................................................ 8
4.9.2 Operating the depth stop ............................................................................ 8
4.9.3 Operating the holding sleeve ..................................................................... 8
5.
Validated processing procedure ................................................................ 9
5.1 Single-use products ...................................................................................... 9
5.2 Reusable products ......................................................................................... 9
5.3 General notes ................................................................................................10
5.4 Preparations at the place of use .............................................................10
5.5 Preparation prior to cleaning ...................................................................10
5.6 Cleaning/Disinfecting .................................................................................10
5.7 Manual cleaning/disinfecting ..................................................................11
5.7.1 Handpiece/Attachment .............................................................................. 11
5.7.2 Tools................................................................................................................. 12
5.8 Mechanical cleaning/disinfecting ...........................................................13
5.8.1 Tools................................................................................................................. 13
5.9 Inspection, maintenance and checks .....................................................14
5.10 Packaging .......................................................................................................14
5.11 Sterilization method and parameters ....................................................14
5.12 Sterilization for the US market ................................................................14
5.13 Storage ...........................................................................................................14
6.
Maintenance .................................................................................................14
7.
Troubleshooting list ....................................................................................15
8.
Technical Service .........................................................................................16
9.
Accessories/Spare parts .............................................................................16
10. Technical specifications .............................................................................17
and complaints .............................................................................................17
1. Safe handling
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Remove the transport packaging and thoroughly clean the new prod-
uct, either by hand or by a mechanical process, prior to its initial ster-
ilization.
Prior to use, check for proper condition and functioning of the product.
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.
- Observe all safety information and maintenance advisories.
- 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.
Do not use craniotome reamers that are longer than the craniotome
handpiece.
Only combine craniotome reamers and craniotome handpieces with
matching ring markings.
3
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