Instructions For Use
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© 2018 Endotronix Inc.
100474-00 Rev 1
3.5 MRI Safety Information
Non-clinical testing and MRI simulations were performed to evaluate
the Cordella Sensor. Non-clinical testing demonstrated that the Cordella
Sensor is MR Conditional. A patient with this implant can be scanned
safely in an MR system under the following conditions:
MR Conditional
• Static magnetic field of 1.5 Tesla or 3 Tesla only
• Maximum spatial gradient magnetic field of 10,000 gauss/cm
(100 T/m)
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e.,
per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the Cordella Sensor is expected
to produce a maximum temperature rise of 4.5°C after 15 minutes of
continuous scanning (i.e. per pulse sequence). If defined MRI conditions
are not followed, there is increased risk of additional heating or movement
of the Cordella Sensor or of damage to the Cordella Sensor.
Selecting the optimal MR imaging parameters may be necessary if the
goal is to image close to the Cordella Sensor. In non-clinical testing, the
image artefact caused by the Cordella Sensor extends approximately 6
mm from this device when imaged with a gradient echo pulse sequence
and a 3 Tesla MR system.
NOTE:
It is important that the patient understands they should inform
clinical staff who will be performing an MRI scan that the patient has
an implanted Cordella Sensor and to refer to these guidelines. The MR
Conditional symbol is on the patient’s implant card, which should be given
to the patient after the implant and be carried with them at all times.
The Cordella Sensor is safe to use with ultrasound imaging, but DO NOT
expose to therapeutic levels of ultrasonic energy.
Contact Endotronix Customer Support (see Contact Us section) for current
MR Conditional labelling and the most up-to-date instructions for this
device in the MR environment.
3.6 Sterilization
The Delivery System package contents have been sterilized with ethylene
oxide before shipment. The system is for single use and is not intended
to be re-sterilized. If the sterile package has been compromised, replace
it with another Delivery System from inventory and contact Customer
Support.
