Integra Codman CERTAS Plus Manual Del Usario página 14

EN – ENGLISH
CERTAS
Programmable Valves
IMPORTANT INFORMATION
Please read before use
Description
The CERTAS™ Plus Programmable Valves are single-use
implantable devices that can be set to eight different
performance settings for intraventricular pressure and drainage
of CSF. The performance settings of the valves can be set
preoperatively and can also be noninvasively changed post-
implantation by using the CERTAS Tool Kits. The CERTAS Tool
Kits employ magnetic force to select one of eight settings. Please
see Figure 1 for diagrams of the valves.
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
When adjusting the valve, the changes between each performance
setting at flow rates of 5, 20, and 50 mL/h are:
Incremental steps between
settings 1,2,3,4
Incremental steps between
settings 4,5,6,7
Setting 8 is intended to limit flow through the valve and has an
average pressure greater than 400 mmH
Plus
™
Flow Rate [mL/h]
Setting 7
Setting 6
Setting 5
Setting 4
Setting 3
Setting 2
Setting 1
±20 mmH O
2
±25 mmH O
2
±35 mmH O
2
15 – 40 mmH
20 – 50 mmH
O.
2
2
O
2
O
2