2
ENGLISH
Table of Contents
Description .......................................................3
Indications ........................................................4
Contraindications ............................................5
Warnings ..........................................................5
Precautions ......................................................6
Adverse Events ................................................7
Magnetic Resonance Imaging (MRI)
Safety Information ...........................................7
Detailed Product Description .........................8
CODMAN CERTAS
®
Plus Programmable
Valve ..............................................................8
SIPHONGUARD
®
Device ..............................9
Accessories ...................................................9
Catheters .......................................................9
Right Angle Adapter ......................................10
Priming Adapter ............................................10
CODMAN CERTAS
®
Tool Kit ..........................10
Description .....................................................10
Disinfecting the CODMAN CERTAS
®
Tool Kit ..............................................................10
How Supplied ...................................................10
Storage – BACTISEAL
®
Catheters .................11
Pre-implantation Performance Testing .........11
Instructions for Use .........................................11
SECTION A: Pre-implantation
Adjustment Procedure ...................................11
SECTION B: Surgical Procedure ...................13
Precautions ...................................................13
Irrigation .........................................................13
Surgical Technique .........................................14
SECTION C: Post-implantation
Adjustment Procedure ...................................14
SECTION D: Troubleshooting ........................16
SECTION E: Confirming the Current
Valve Setting ..................................................17
SECTION F: Reading the Valve Setting
with the X-Ray Overlay Tool ...........................17
Injection ............................................................18
Valve Flushing (Clearing Obstructions) .........18
CODMAN CERTAS
®
Tool Kit Replacement ...18
Warranty ...........................................................18
Appendix A .......................................................19
Optional Manometer Testing ..........................19
SIPHONGUARD
®
Device Functional
Testing ............................................................19
Manometer Testing ........................................20