Merit Medical scout Instrucciones De Uso página 3

SYMBOL
Use By: YYYY-MM-DD
Lot Number
Catalog Number
Sterilized Using Ethylene Oxide
Do Not Use if Package is Damaged
Single Use
Caution: Federal (USA) law restricts this device to sale by or on the order of
a physician
Do Not Re-sterilize
Caution: Consult accompanying documents
Date of Manufacture
Medical Device.
Sterile Package. Sterile Package.
MRI Safety Information
MR Conditional
The SCOUT Reflector is MR Conditional.
Non-clinical testing demonstrated that the SCOUT Reflector 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 or less
• Maximum spatial gradient magnetic field of 3,000-Gauss/cm (30T/m) (extrapolated) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg)
(First Level Controlled Operating Mode)
MRI-Related Heating
Under the scan conditions defined above, the SCOUT Reflector is expected to produce
a maximum temperature rise of 2.5o C after 15 minutes of continuous scanning (per pulse
sequence).
Artifact Information
In non-clinical testing, the image artifact caused by the device extends approximately 5 mm
from the SCOUT Reflector when imaged with a gradient echo pulse sequence and a 3-Tesla MRI
system.
DESIGNATION