AMS 800 Instrucciones De Uso página 12

Magnetic Resonance Imaging (MRI)
Important Safety Information
MR
MR Conditional
Non-clinical testing has demonstrated the AMS 800 product line
is MR Conditional. The device can be scanned safely under the
following conditions:
Static Magnetic Field
Spatial Gradient Field
Maximum whole
body averaged Specific
Absorption Rate
(SAR)
MRI-Related Heating
Non-clinical testing has demonstrated the AMS 800 product line
produced the temperature rises during MRI performed for
15 minutes of scanning in the respective MR systems which
would not pose a hazard to the human subject.
Static Magnetic Field
Highest Temperature
Change
(a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milwaukee, WI)
(b) 3.0T MR Excite, General Electric Healthcare, software version 14X.M5
Artifact Information
Non-clinical testing has demonstrated that the AMS 800
product line may compromise the MR image quality if the area
of interest is relatively close to the position of the implant. The
maximum image artifact produced by a MR gradient echo pulse
sequence was a "moderate" localized signal void in size and shape
of the implant. Optimization of MR imaging parameters to
compensate for the presence of the device may be necessary.
Pulse
T1-SE
Sequence
Signal Void 5,800
Size mm
Plane
Parallel
Orientation
Inventory Returns and Product Replacement
Information
A Patient Information Form (PIF) must be filled out and
filed with AMS at the time of implant to activate the product
warranty. Contact your local AMS Representative prior to
returning any product. Before returning any components,
whether explanted or unused (sterile or nonsterile), customers
must fill out the Return Goods Form located on the last page of
the Patient Information Form. Follow all of the instructions on
the form carefully, and be sure that the components have been
thoroughly cleaned before returning them to AMS. Request
an AMS Product Return Kit from the AMS Customer Service
Department to return any explanted components to AMS.
In all cases, obtaining credit or percentage of credit for a
returned component is subject to approval under the terms of
the AMS Return Goods Policy and the AMS Limited Warranty
Policy. For complete information regarding these policies, contact
the AMS Customer Service Department.
This document is written for professional medical audiences.
Contact American Medical Systems for lay publications.
American Medical Systems periodically updates product
literature. If you have questions about the currency of this
information, contact American Medical Systems.
10
1.5 Tesla
a
450 Gauss/cm or
less
1.5 W/kg for 15
minutes of scanning
as assessed by
calorimetry
1.5 Tesla
a
≤ + 0.4 °C
T1-SE
1,956 mm
2
2
Perpen-
dicular
3.0 Tesla
b
720 Gauss/cm or
less
2.9 W/kg for 15
minutes of scanning
as assessed by
calorimetry
3.0 Tesla
b
≤ + 2.0 °C
GRE GRE
6,096 2,650
mm mm
2 2
Perpen-
Parallel
dicular