B.Braun VenaTech LP Manual Del Usuario página 5

• Compatibility with Magnetic Resonance Imaging (MRI)
Conditional
The VenaTech® LP, Vena Cava Filter was determined to be MR-Conditional
according to the terminology specified in the American Society for Testing and
Materials (ASTM) International, Designation: F2503-08. Standard Practice for
Marking Medical Devices and Other Items for Safety in the Magnetic Resonance
Environment.
Non-clinical testing demonstrated that the VenaTech® LP, Vena Cava Filter is MR
Conditional. A patient with this device can be scanned safely, immediately after
placement under the following conditions:
• Static magnetic field of 3-Tesla and 1.5-Tesla
• Maximum spatial gradient magnetic field of 710 Gauss/cm or less
• The scanner can be operated in the Normal Operating Mode with a maximum
whole body averaged specific absorption rate (SAR) of 2.0 W/kg or in the First
level Controlled Mode with a maximum SAR of 4.0 W/kg for 15 minutes of
scanning.
MRI-Related Heating
In non-clinical testing, the VenaTech® LP Vena Cava Filter produced the follow-
ing temperature rise during MRI performed for 15-min (i.e., per pulse sequence)
in 3-Tesla (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee,
WI) MR systems, as:
MRI Condition MR System Reported, Maximum
Whole Body Average SAR (W/kg)
3-T / 128-MHz
Artifact Information
MR image quality may be compromised if the area of interest is in the exact same
area or relatively close to the position of the VenaTech® LP, Vena Cava Filter.
Therefore, optimization of MR imaging parameters to compensate for the pres-
ence of this device may be necessary.
The maximum artifact size extends approximately 11-mm relative to the size and
shape of the VenaTech® LP, Vena Cava Filter when scanned in non-clinical test-
ing using the sequence gradient echo pulse sequence in a 3T MR system (Intera
Achieva upgrade) – Phillips Medical Systems Best, The Netherlands (software ver-
sion: 2.5.3.3 2007-09-28) with a transmit/receive birdcage coil, 28 cm long, 27
cm in diameter.
Calorimetry Value
2.9
4
Highest Temperature
(W/kg) Change
2.7 + 2.8 °C
Time for MRI
(per pulse sequence)
15-min