Braun Aesculap TSPACE 3D, Instructions For Use/Technical Description

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Aesculap ® TSPACE ® PEEK/TSPACE ® XP /TSPACE ® 3D
Instruments
Legend
A Insertion instrument SN305R (assembled)
B Insertion instrument SN305R (disassembled):
1 Tube
2 Switch
3 Rotary nut
4 Irrigation connector
5 Pin
6 Rod
7 Dihedron
C Impact cylinder SN320R
D Trial implant
E Filling holder SN304R
Contents
1. About this document. . . . . . . . . . . . . . . . . . . 2
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Safety messages. . . . . . . . . . . . . . . . . . . . . . . 4
2. Clinical use . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Areas of use and limitations of use . . . . . . . 4
2.1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.3 Contraindications . . . . . . . . . . . . . . . . . . . . . 4
2.2 Safety information. . . . . . . . . . . . . . . . . . . . . 4
2.2.1 Clinical user . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.2 Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.3 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3.1 Preparing the implant bed . . . . . . . . . . . . . . 5
2.3.2 Determining the implant height with the
trial implant . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3.3 Inserting the implant in the implant bed . . 7
3. Validated reprocessing procedure . . . . . . . . 8
3.1 General safety information . . . . . . . . . . . . . . 8
3.2 General information . . . . . . . . . . . . . . . . . . . 9
3.3 Reusable products . . . . . . . . . . . . . . . . . . . . . 9
3.4 Preparations at the place of use. . . . . . . . . . 9
3.5 Preparing for cleaning . . . . . . . . . . . . . . . . . . 9
3.6 Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.7 Cleaning/Disinfection . . . . . . . . . . . . . . . . . . 10
3.7.1 Product-specific safety information on the
reprocessing method . . . . . . . . . . . . . . . . . . 10
3.7.2 Validated cleaning and disinfection
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.8 Manual cleaning/disinfection . . . . . . . . . . . 11
3.8.1 Manual cleaning with immersion
disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.8.2 Manual cleaning with ultrasound and
immersion disinfection . . . . . . . . . . . . . . . . 13
3.9 Mechanical cleaning/disinfection . . . . . . . . 14
3.9.1 Mechanical alkaline cleaning and thermal
disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.10 Mechanical cleaning/disinfection with
manual pre-cleaning . . . . . . . . . . . . . . . . . . 15
3.10.1 Manual pre-cleaning with a brush . . . . . . . 15
3.10.2 Manual pre-cleaning with ultrasound and
brush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.10.3 Mechanical alkaline cleaning and thermal
disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.11 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.11.1 Visual inspection . . . . . . . . . . . . . . . . . . . . . 17
3.11.2 Functional test . . . . . . . . . . . . . . . . . . . . . . . 18
3.12 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.13 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.14 Steam sterilization . . . . . . . . . . . . . . . . . . . . 18
3.15 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4. Technical service . . . . . . . . . . . . . . . . . . . . . 18
5. Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6. Symbols on product and packaging . . . . . . 19
1. About this document
Note
General risk factors associated with surgical procedures
are not described in these instructions for use.