Description; Indications For Use/Intended Purpose; Warnings - Codman 82-8851 Manual Del Usuario

IMPORTANT INFORMATION
Please read before use
CODMAN CERTAS
(REF 82-8851)

Description

The CODMAN CERTAS
adjust and confirm the performance setting of
a CODMAN CERTAS
Plus Programmable Valve. The actions are
performed both preoperatively (with the valve
still in the sterile package) and postoperatively
(on the implanted valve) through noninvasive
means. The CODMAN CERTAS Tool Kit employs
magnetic force to change the performance
setting. Please see Figure 1A for images of the
CODMAN CERTAS Tool Kit components.

Indications for use/Intended Purpose

The CODMAN CERTAS Tool Kit allows the
noninvasive reading or adjustment of the
valve setting.
Any serious incident that has occurred in relation
to the device to the patient and/or the end user
should be reported to the manufacturer and the
competent authority of the Member State in which
the user and/or patient is established.

Warnings

The Indicator Tool has a precise operating
•
mechanism and is vulnerable to damage if
mishandled. Store and carry all components
of the Tool Kit in the storage case when not in
use to prevent damage. Replace the Indicator
Tool immediately if dropped (or suspected of
being dropped) to ensure accurate performance.
Replacement Indicator Tools are available from
your local Integra representative.
Do not interchange the CODMAN CERTAS
•
Tool Kit (82-8551) components with the
components of the CODMAN CERTAS
Therapy Management System TMS (82-8850).
Tool Kit
®
Tool Kit is used to
®
or CODMAN CERTAS
®
2
®