Integra Codman CERTAS Plus Manual Del Usario página 18

EN – ENGLISH
• MRI scan duration shall not exceed 15 minutes of continuous
scanning
WARNING: Do not use Transmit / Receive or Transmit-only
•
RF Head coils. Only use Transmit / Receive RF Body coil or
Transmit RF Body coil / Receive-only RF Head coil.
• WARNING: Do not use Transmit / Receive or Transmit-only
local coils that are placed directly over the location of valve.
WARNING: Per IEC 60601-2-33: 2010+A12:2016 the
•
maximum patient core temperature for a scan with a whole-
body SAR of 4 W/kg (i.e. First Level Controlled Operating
Mode) is 40°C.
Under the scan conditions defined above, the CERTAS Plus
Programmable Valve is expected to produce a maximum
Temperature rise of 3.4°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device
extends approximately 25 mm from the CERTAS Plus Valve when
imaged with a gradient echo pulse sequence and a 3T MRI System.
MRI Additional Information
• Maximum spatial gradient magnetic field of 1,000-Gauss/cm
(extrapolated) or less.
• The highest SG magnetic field is commonly located off-
axis, at a side wall, and near the opening of the bore of the
scanner. Please refer to MRI manufacturers published value
and location of the peak SG that is accessible to the patient.
• Maximum MR system reported, whole body SAR of 4-W/kg
determined with 15 minutes of scanning (i.e., per pulse
sequence).
• The temperature rise during MRI performed for 15-min of
scanning (i.e., per pulse sequence) in an RF exposure system
(3T MR system simulator; 3.0 T/127.68 MHz, MITS 3.0,
Software MITS 1.2.1, Zurich Med Tech):
Calorimetry measured values, whole body averaged SAR
o
4.60-W/kg
Highest temperature change 3.9°C
o
Temperature scaled to whole body averaged SAR of
o
4-W/kg 3.4°C
Specific Guidelines
The valve setting should be verified after the MRI procedure.
Detailed Product Description
CERTAS Plus Programmable Valve
The valve features an adjustable mechanism and a reservoir.
All valves are marked with a radiopaque direction-of-flow
arrow and a right-hand side (RHS) marker. A priming adapter
is included with all valves. Valves are available with or without
SIPHONGUARD. Valves are also available with or without
accessories, including silicone catheters or BACTISEAL
Catheters (see Figure 1).
Programmable Valve Configurations
Inline with SIPHONGUARD
Inline
Inline Small with SIPHONGUARD
Inline Small
Right Angle with SIPHONGUARD
Right Angle
The valves are designed for use with catheters having the
following dimensions:
6
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