COOK Medical Tenckhoff Instrucciones De Uso página 3

TENCKHOFF CHRONIC PERITONEAL DIALYSIS
CATHETERS AND SETS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
Tenckhoff Chronic Peritoneal Dialysis Catheters are sideported silicone
catheters with dual retention cuffs available in a range of lengths and French
sizes and in either a straight or spiral tip configuration. Sets also contain an
appropriately sized access needle, a wire guide and accessories for use in
catheter placement.
INTENDED USE
Tenckhoff Chronic Peritoneal Dialysis Catheters are intended for chronic
access to the peritoneal cavity.
MRI INFORMATION
Nonclinical testing has demonstrated that the Tenckhoff Chronic Peritoneal
Dialysis Catheter is MR Conditional. It can be safely scanned after placement
under the following conditions:
• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient field of 1600 Gauss/cm or less
• Normal operating mode: Maximum whole-body-averaged specific
absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less (i.e.,
per scanning sequence)
Static Magnetic Field
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
In nonclinical testing, the Tenckhoff Chronic Peritoneal Dialysis Catheter
produced a maximum temperature rise of 1.7 °C during 15 minutes of MR
imaging (i.e., for one scanning sequence) performed in a MR 3.0 Tesla System
(Siemens Magnetom Trio, A Tim System, Software Numaris/4) at an MR system
reported whole-body-averaged SAR of 2.1 W/kg (associated with a calorimetry
measured whole-body-averaged value of 1.7 W/kg).
Image Artifact
The image artifact does not extend from the device, but the device lumen is
obscured when scanned in nonclinical testing using: GRE sequence in a 3.0
Tesla Siemens Magnetom Trio, A Tim System (Software Numaris/4) MR system
with the body coil.
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
Web: www.medicalert.org
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
The product is intended for use by physicians trained and experienced in
diagnostic, interventional and surgical techniques. Standard techniques for
placement of percutaneous catheters should be employed.
INSTRUCTIONS FOR USE
1. Select a placement site that avoids both the inferior epigastric artery and
any abdominal scars, so as to minimize the risk of entering the bowel
adherent to the anterior abdominal wall. Both midline and paramedian
abdominal sites below the umbilicus and low lateral sites have been used
successfully.
2. After prepping the skin as for any sterile surgical procedure, infiltrate local
anesthetic.
3. Make a 1 cm skin incision, followed by minimal blunt dissection down
through the subcutaneous tissue.
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