COOK Medical EchoTip Ultra Bedienungsanleitung Seite 4

MRI INFORMATION
MR Conditional
MR
Non-clinical testing has demonstrated that the fiducial marker is MR Conditional according to
ASTM F2503. A patient with this marker can be scanned safely anytime after placement under the
following conditions.
Static Magnetic Field
• Static magnetic field of 3 Tesla or less
• Highest spatial magnetic gradient field of 720 Gauss/cm or less
Non-clinical evaluation was conducted in a MR system (Excite, General Electric Healthcare) with
a maximum spatial magnetic gradient field of 720 Gauss/cm as measured with a gaussmeter in
the position of the static magnetic field pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
• 1.5 and 3.0 Tesla Systems: It is recommended to scan in normal operation mode (whole body
averaged specific absorption rate (SAR) = 2.0W/kg) ("Normal Operating Mode" is defined as
the mode of operation of the MR system in which none of the outputs have a value that cause
physiological stress to the patient) for 15 minutes of scanning (i.e., per scanning sequence).
In non-clinical testing, the fiducial marker produced maximum temperature rises of 1.5 °C
during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a 3 Tesla MR
System (Excite, HDx, GE Electric Healthcare, Milwaukee, WI, Software 14X.M5) at an MR system
reported whole-body-averaged SAR of 2.9 W/kg (associated with a calorimetry measured
whole body averaged value of 2.7 W/kg).
Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 26 mm
of the position of the fiducial marker, as found during non-clinical testing using the sequence:
T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 Tesla MR system (Excite, HDx,
General Electric Healthcare, Milwaukee, WI, Software 14X.M5). Therefore, it may be necessary to
optimize MR imaging parameters for the presence of this metallic marker.
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the
MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:
Mail:
MedicAlert Foundation International, 2323 Colorado Avenue, Turlock, CA 95382
Phone: 888-633-4298 (toll free) / 209-668-3333 from outside the US
Fax:
209-669-2450
SYSTEM PREPARATION
1. To adjust sheath length, loosen thumbscrew lock on sliding sheath adjuster and slide handle
until preferred length is attained (See fig. 1). Tighten thumbscrew.
2. Advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker.
Note: Excessive pressure on stylet may result in premature deployment.
INSTRUCTIONS FOR USE
1. Identify desired site based on previous findings from endoscopy, radiography and/or
CT scans.
2. Slowly introduce needle into accessory channel of endoscope and advance in short
increments. Ensure needle is completely retracted and locked in place (See fig. 2).
Note: Bends or kinks in needle caused by improper introduction may result in the inability
to deploy fiducials.
3. Attach device to endoscope accessory channel port.
4. With endoscope and device straight, advance needle to desired length by loosening
thumbscrew on safety ring, and advancing it until desired reference mark appears in
window of safety ring (See fig. 3). Tighten thumbscrew to lock safety ring in place.
Note: The number in safety lock ring window indicates extension of needle in centimeters.
Web: www.medicalert.org
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