Description - Codman CERTAS Plus Manual Del Usario

IMPORTANT INFORMATION
Please read before use
CODMAN CERTAS
Plus Programmable Valve
CODMAN CERTAS

Description

The CODMAN CERTAS Plus Programmable Valve
is a single use implantable device designed for
shunting cerebrospinal fluid (CSF) for the treatment of
hydrocephalus. The valve can be set to eight different
performance settings for intraventricular pressure
and drainage of CSF. The performance setting of
the valve can be set preoperatively and can also be
noninvasively changed post-implantation by using the
CODMAN CERTAS Tool Kit. The CODMAN CERTAS Tool
Kit employs magnetic force to select one of 8 settings.
Please see Figure 1 for diagrams of the valve and
Figure 2 for diagrams of the Tool Kit.
Graph 1
Each CERTAS™ Plus Valve is calibrated and tested at the
time of manufacture. Graph 1 describes the pressure-flow
performance characteristics of the device as required
by ISO 7197:2009. In addition, long-term stability
performance of the device has been demonstrated
through testing in accordance to this standard. The
pressure shown in the graph for each setting is an
average recorded with active flow through the valve alone
at flow rates of 5, 20 and 50 mL/h; the value at 20 mL/h is
shown. Note that testing of the device may give different
results depending on the test conditions.
The devices performed within a tolerance range of
the average pressure as shown here regardless of
gravitational orientation:
Settings 1, 2, 3
Setting 4
Settings 5, 6, 7
Valve Products, including Accessories
Tool Kit
Flow Rate [mL/h]
®
Tool Kit
®
Setting 7
Setting 6
Setting 5
Setting 4
Setting 3
Setting 2
Setting 1
O
±20 mmH
2
±25 mmH O
2
±35 mmH O
2
3