COOK Medical NASAL BILIARY DRAINAGE SET, Instructions For Use Manual

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Non-clinical testing has demonstrated the Nasal Biliary Drainage Sets which
contain radiopaque marker bands are MR Conditional. These devices have part
numbers with a –RT suffix. A patient with these devices can be safely scanned in an
MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial field gradient of 1,900 gauss/cm (19 T/m)
• Maximum MR system reported, whole body average specific absorption rate
(SAR) of 4 W/kg
In non-clinical testing, the image artifact caused by the device extends
approximately 4 mm from the Nasal Biliary Drainage Set when imaged with a
gradient echo pulse sequence and a 3 T MR system.
This symbol means the device is MR Safe.
The Nasal Biliary Drainage Sets which do not contain radiopaque marker bands are
MR Safe.
In non-clinical testing, the image artifact caused by the device extends
approximately 4 mm from the Nasal Biliary Drainage Set when imaged with a
gradient echo pulse sequence and a 3 T MR system.
INSTRUCTIONS FOR USE
1. Visually inspect the packaging confirming it is unopened and free from damage
prior to use.
2. Visually inspect the device confirming it is free from damage prior to use.
3. Flush drainage catheter using a sterile syringe filled with sterile water or saline
attached to Luer lock fitting on end of catheter.
4. Carefully remove Tuohy-Borst connector from end of drainage catheter.
5. If tip of drainage catheter is configured with a pigtail and is preloaded with
a pigtail straightener, advance pigtail straightener along shaft and to tip of
catheter to straighten pigtail curl.
CAUTION: Care must be exercised when straightening pigtail curl in order to
avoid kinking or breaking catheter.
6. Introduce drainage catheter and pigtail straightener, if any, onto pre-positioned
wire guide and advance in small increments until the catheter enters the
accessory channel of endoscope.
CAUTION: Ensure the pigtail straightener, if any, remains positioned at tip of
catheter in order to avoid kinking or breaking catheter.
7. Continue to advance drainage catheter in small increments until pigtail portion
of the catheter has fully entered the accessory channel of endoscope. Remove
pigtail straightener from the catheter.
Illustrations
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