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`~ìíáçåK=Do not suture directly to the outside diameter of the
catheter, to minimize the risk of cutting or damaging the catheter
or impeding catheter flow.
14. Dress the puncture site per hospital protocol. Maintain the
insertion site with regular meticulous redressing using aseptic
technique.
15. Record on the patient's chart the indwelling catheter length using
the centimeter marks on the catheter shaft as reference. Frequent
visual reassessment should be made to ensure that the catheter
has not moved.
16. Attach a primed Start-Up Kit to the catheter: Connect the male Luer
of the Start-Up Kit to the female IN Luer of the catheter (labeled
"IN"). Connect the female Luer of the Start-Up Kit to the male
OUT Luer of the catheter (labeled "OUT"). White "ZOLL" tags are
fitted loosely to the IN and OUT extension tubes to help identify
them.
kçíÉK=The Start-Up Kit IN and OUT Luers are only intended to con-
nect to the catheter IN and OUT Luers. They have ZOLL custom fit-
tings and are orange in color for easy identification.
17. Ensure that a sufficient amount of sterile saline is present at the
ends of the Luers to make an air-free connection. Refer to the
operation manual.
t^okfkdK=Failure to connect the Start-Up Kit correctly to the
catheter could result in catheter failure. Do not attach Start-Up Kit
(orange) Luers to the dark blue, white, or brown Luers.
`~ìíáçåK=Do not attach the Start-Up Kit to the distal port.
`~ìíáçåK=Do not place any stopcocks in line that may be inadver-
tently shut off. This can cause line blockage and possible failure.
18. Pump saline through the Start-Up Kit and catheter to ensure that
all connections are secure and that there is no leaking. Allow any
remaining air in the system to be purged out as described in the
operation manual.
aáëÅçååÉÅíáåÖ=íÜÉ=Å~íÜÉíÉê=Ñêçã=íÜÉ=ÅçåëçäÉ
1.
Stop circulation of saline through the catheter.
2.
Disconnect the Start-Up Kit from the catheter.
3.
To maintain sterile connections, immediately cap off the Luer
connectors of both the catheter and Start-Up Kit using sterile Luer
caps, or connect the IN and OUT Luers together.
oÉÅçååÉÅíáåÖ=íÜÉ=Å~íÜÉíÉê=íç=íÜÉ=ÅçåëçäÉ
1.
Remove the Luer caps from the Luer connectors of the catheter
and Start-Up Kit. Discard the Luer caps or disconnect the IN and
OUT Luers from each other.
2.
Attach the Start-Up Kit to the catheter: Connect the male Luer of
the Start-Up Kit to the female IN Luer of the catheter. Connect the
female Luer of the Start-Up Kit to the male OUT Luer of the
catheter. The Start-Up Kit and catheter IN and OUT Luers are
orange in color. Ensure that a sufficient amount of sterile saline is
present at the ends of the Luers to make an air-free connection.
t^okfkdK=Failure to connect the Start-Up Kit correctly to the
catheter could result in catheter failure.
t^okfkdK=DO NOT use the IN and OUT Luer fittings for standard
central line infusion ports. They are for connection to the
Coolgard 3000 or Thermogard XP console only.
The Start-Up Kit IN and OUT Luers are only intended to connect to
the catheter IN and OUT Luers. They have ZOLL custom fittings
and are orange in color for easy identification.
`~ìíáçåK=Do not place any extra stopcocks in line that may be
inadvertently shut off. This can cause line blockage and possible
failure.
6/129
oÉãçîáåÖ=íÜÉ=Å~íÜÉíÉê
1.
Stop pumping saline through the catheter.
Disconnect the Start-Up Kit from the catheter. råÅ~é=çê=äÉ~îÉ=
2.
ìåÅ~ééÉÇ=íÜÉ=fk=~åÇ=lrq=iìÉêë=çÑ=íÜÉ=Å~íÜÉíÉêK This will allow
residual saline within the circuit to be expressed. 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 IN Luer.
Pull and hold a vacuum for 15 seconds to allow residual saline to
be removed from the catheter balloon section prior to removing
the catheter.
kçíÉK=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.
4.
Place the patient in a supine position. Remove the dressing.
Remove the sutures from the suture site.
t^okfkdK=Do not place a Luer cap on the OUT Luer.
5.
Slowly remove the catheter from the patient. As the catheter exits
the site, apply pressure with a dressing impermeable to air
(e.g. Vaseline gauze).
t^okfkdK=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 resis-
tance.
jof=ë~ÑÉíó=áåÑçêã~íáçå
Non-clinical testing has demonstrated that the
Quattro catheter is jo=`çåÇáíáçå~ä. A patient with
this device can be scanned safely in an MR system
meeting the following conditions:
•
The catheter must be disconnected from the console
•
Static magnetic field strength of 1.5 T or 3 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 catheter is expected to
produce a maximum temperature rise of less than 2ºC after 15 minutes
of continuous scanning.
t^okfkdK=The ZOLL Coolgard 3000 and Thermogard XP consoles are
MR Unsafe. Do not use in the MR Suite.
jof=~êíáÑ~Åíë
The presence of the catheter may cause moderate artifacts on the MRI
image depending on the pulse sequence parameters used for the MRI.
However, artifacts are confined to the position of the catheter, and, as
such, will not affect the diagnostic use of MRI imaging for head-only
MRI examinations.
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