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Codman Neuro DePuy Synthes CERTAS Plus User Manual

Codman Neuro DePuy Synthes CERTAS Plus
191 pages
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LCN 206521-001/H
© 2010-2016 DePuy Synthes Products, Inc.
Revised 04/16
CODMAN CERTAS
®
Plus
Programmable Valve
CODMAN CERTAS
®
Tool Kit
Medos International SÀRL
Chemin-Blanc 38
2400 Le Locle, Switzerland
+41 32 934 80 00
US
Codman Neuro
325 Paramount Drive
Raynham, MA 02767-0350 USA
800 225 0460
+1 508 828 3000
(For Class II and III products, the Notified Body number is 0086)
206521-001-H-INS.indd 1 4/29/16 3:34 PM

Table of Contents

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Codman Neuro DePuy Synthes CERTAS Plus Specifications

General IconGeneral
MaterialTitanium housing
MRI CompatibilityMRI conditional
IndicationHydrocephalus
MRI ConditionalYes
ApplicationHydrocephalus
Adjustment MechanismAdjustable
Product TypeProgrammable valve
AdjustabilityAdjustable
Valve TypeBall-in-cone
Catheter CompatibilityVentricular

Summary

Important Information and Safety Guidelines

Product Description and Indications

Introduces the programmable valve, tool kit, and specifies intended uses.

Contraindications and Warnings

Lists conditions for non-use and critical safety warnings.

Precautions and Adverse Events

Details safe handling steps and potential negative outcomes.

MRI Safety Information

Guidelines for using the device in MRI environments.

Detailed Product Description

Valve and Component Details

Describes valve features, SIPHONGUARD, accessories, and catheters.

CODMAN CERTAS Tool Kit Overview

Details the components, purpose, and handling of the tool kit.

Product Supply and Disinfection

Information on product packaging, single-use policy, and tool kit cleaning.

Instructions for Use

Pre-implantation Adjustment Procedure

Procedure for setting the valve performance before implantation.

Surgical Procedure and Irrigation

Steps for surgical placement, including precautions and irrigation.

Post-implantation Adjustment and Troubleshooting

Adjusting valve setting after implantation and resolving issues.

Confirming and Reading Valve Settings

Methods to verify and read the valve's performance setting.

Injection and Valve Flushing

Procedures for injection and clearing valve obstructions.

Appendix A: Optional Manometer Testing

SIPHONGUARD Device Functional Testing

Procedure to test the proper functioning of the SIPHONGUARD Device.

Manometer Test Setup and Procedure

Steps for setting up, zeroing, and performing a manometer test.

Manometer Test Results Interpretation

How to interpret the results of the manometer test.