Cool Line
®
Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
5 of 10
ZOLL
4.
The Start-Up Kit IN and OUT Luers are only intended to
connect to the catheter IN and OUT Luers and are not
intended to connect to standard Luer Lock syringes. They
have ZOLL custom fittings and are orange in color for
easy identification.
5.
Caution: Do not place any extra stopcocks in line that
may be inadvertently shut off. This can cause line
blockage and possible failure.
Catheter Removal
1.
Stop pumping saline through the catheter.
2.
Disconnect the Start-Up Kit from the catheter. Uncap or
leave uncapped the IN and OUT Luers of the cooling
circuit (cooling circuit ONLY). This allows residual saline
within the circuit to be expelled. As the catheter is
withdrawn, the balloons are compressed. Saline within the
balloons must be free to pass out of the balloon or the
balloon will not deflate, making the catheter difficult to
remove.
3.
Optionally, attach a 20 or 25 cc syringe to the catheter
saline IN Luer. Pull and hold a vacuum for 15 seconds to
allow residual saline to be removed from the catheter
balloon section prior to the start of removing the catheter.
4.
For convenience, a 20 or 25 cc syringe is included with
the Start-Up Kit package. Hang it on the saline hook on
the console until ready for use. Discard after each patient.
5.
Place the patient in a supine position. Remove the
dressing. Remove the sutures from the suture site.
6.
Slowly remove the catheter from patient. As the catheter
exits the site, apply pressure with a dressing impermeable
to air, e.g. Vaseline gauze.
7.
Warning: Do not move the catheter if resistance is felt.
Check to ensure that the IN and OUT Luers of the
cooling circuit are NOT capped. If they are capped,
uncap them, deflate the balloon, and try removing the
catheter again. If resistance is still encountered, an x-
ray should be performed to identify the reason for the
resistance.
MRI
Safety
Information
Non-clinical testing has demonstrated that the
Cool Line catheter is MR Conditional. A patient
with this device can be safely scanned in an MR
system meeting the following conditions:
Static magnetic field of 1.5 T and 3.0 T
Maximum spatial field gradient of 720 gauss/cm
(7.2 T/m)
Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 2 W/kg (Normal
Operating Mode)
Under the scan conditions defined above, the Cool Line catheter
is expected to produce a maximum temperature rise of less than
2º C after 15 minutes of continuous scanning.
WARNING: The ZOLL Coolgard 3000 and Thermogard
XP Consoles are MR Unsafe. Do not use in the MR Suite.
ZOLL Circulation, Inc.
2000 Ringwood Avenue
San Jose, CA 95131 USA
+1-408-541-2140 (main)
+1 (408) 541-1030 (fax)
Reorder USA only: +1-978-421-9655
©2019 ZOLL Medical Corporation. All rights reserved. ZOLL
and Cool Line are trademarks or registered trademarks of
ZOLL Medical Corporation and/or ZOLL Circulation Inc. in
the United States and/or other countries. All trademarks are
the property of their respective owners.
Patent: www.zoll.com/patents