B. Braun Aesculap S4 Cervical, Instructions For Use/Technical Description

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2
en
Aesculap
®
S
4®
Cervical
Navigated Instruments
Legend
A Navigated tapper
Ø
3.5 mm (FW655R)
B Reference star unit (pre-calibrated) (Brainlab Art. no. 55830-20A)
C Handle (FW165R with ratchet or FW067R without ratchet)
D Navigated screwdriver for polyaxial screw (FW656R)
E Reference star unit ML (calibration with ICM4) (Brainlab
Art. no. 55830-25A)
F Navigated drill guide
Ø
3.5 mm (FW664R)
G Navigated drill guide
Ø
4.0 mm (FW665R)
H Aesculap star unit navigation attachment (FW652R)
I Navigated guide sleeve
Ø
4.0 mm for smooth-shaft screws (FW658R)
J Reduction sleeve
Ø
13 mm for Brainlab instrument calibration matrix
version 4 (FW657R)
K Navigated guide sleeve
Ø
3.5 mm/4.0 mm (FW660R)
L C1/C2 inner drill sleeve
Ø
4 mm (FJ985R)
M C1/C2 inner drill sleeve
Ø
3.5 mm (FW661R)
N C1/C2 drill
Ø
2.4 mm (FW662SU)
O C1/C2 tapper
Ø
3.5 mm (FW663R)
P Centering tool for navigated drill guide
Ø
3.5 mm FW664R (FW688R)
Q Centering tool for navigated drill guide
Ø
4.0 mm FW665R (FW689R)
R Drill
Ø
2.4 mm for FW664R (FW666SU)
S Drill
Ø
2.9 mm for FW665R (FW667SU)
Contents
1. About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Safety messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Clinical use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Areas of use and limitations of use . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.3 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2.1 Clinical user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2.2 Product-specific safety information. . . . . . . . . . . . . . . . . . . . . . 3
2.2.3 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3.1 Preparing holes for S4C screws with navigation. . . . . . . . . . . . 5
2.3.2 Drilling holes for the S4C screws . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3.3 Drilling holes for S4C screws Ø 3.5 mm/4.0 mm. . . . . . . . . . . . 6
2.3.4 Tapping (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3.5 Position S4C screw under navigation and temporarily fix it in
place . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
2.3.6 Smooth-shaft screw instruments . . . . . . . . . . . . . . . . . . . . . . . . 8
2.3.7 Instruments for Favored Angle screws . . . . . . . . . . . . . . . . . . . . 9
2.3.8 Standard screw (Ø 3.5 mm) instrumentation with Favored
Angle instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 General safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3 Single-use products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4 Reusable products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.5 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . 12
3.6 Preparing for cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7 Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7.1 S4C navigated tapper Ø 3.5 mm FW655R . . . . . . . . . . . . . . . . 12
3.7.2 S4C navigated screwdriver FW656R . . . . . . . . . . . . . . . . . . . . . 12
3.7.3 S4C navigated drill sleeve Ø 3.5 mm (FW664R)/Ø 4.0 mm
(FW665R). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R 12
3.7.5 S4C navigated guide sleeve Ø 3.5 mm/4.0 mm FW660R. . . . . 13
3.8 Cleaning/Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.8.1 Product-specific safety information on the reprocessing
method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.8.2 Validated cleaning and disinfection procedure . . . . . . . . . . . . 13
3.9 Manual cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.9.1 Manual cleaning with immersion disinfection . . . . . . . . . . . . . 15
3.9.2 Manual cleaning with ultrasound and immersion disinfection 16
3.10 Mechanical cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . 17
3.10.1 Mechanical alkaline cleaning and thermal disinfecting . . . . . 17
3.11 Mechanical cleaning/disinfection with manual pre-cleaning. 18
3.11.1 Manual pre-cleaning with a brush . . . . . . . . . . . . . . . . . . . . . . 18
3.11.2 Manual pre-cleaning with ultrasound and brush . . . . . . . . . . 19
3.11.3 Mechanical alkaline cleaning and thermal disinfecting . . . . . 19
3.12 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.12.1 Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.12.2 Functional test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13.1 S4C navigated tapper Ø 3.5 mm, FW655R . . . . . . . . . . . . . . . . 20
3.13.2 S4C navigated screwdriver FW656R . . . . . . . . . . . . . . . . . . . . . 20
3.13.3 S4C navigated drill sleeve Ø 3.5 mm (FW664R)/Ø 4.0 mm
(FW665R). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R 20
3.13.5 S4C navigated guide sleeve Ø 3.5 mm/4.0 mm, FW660R . . . . 21
3.14 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.15 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.16 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4. Technical service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21