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ZOLL ICY IC-3893A Instructions For Use Manual
ZOLL ICY IC-3893A Instructions For Use Manual

ZOLL ICY IC-3893A Instructions For Use Manual

Intravascular heat exchange catheter (custom luer)

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®
ICY
Intravascular Heat Exchange Catheter (Custom Luer)
Caution: Federal law restricts this device to sale by or on the
order of a physician.
®
ICY
Intravascular Heat Exchange Catheter (ICY Catheter)
Kit includes:
Quantity
English
ICY Catheter 3-Luer
9.3 French x 38 cm
Triple Infusion Luer
1
Extension Line Clamps
Radiopaque Shaft
Applause Heparin Coating
2
Guidewires .032" (0.81 mm) x 75 cm
Vessel Dilator 10.5 F x 0.38"
1
(3.6 mm x 1.0 mm)
1
Detachable Suture Tab & Clip
18 ga x 2 ½" (1.3 mm x 6.3 cm) Radiopaque OTN
1
Catheter
1
000 Silk Suture
®
1
Chloraprep
Triple Swabstick Prep Pack
6
4" x 4" (10 cm x 10 cm) Gauze Sponges
1
No. 11 Surgical Blade w/ long handle
3 cc Syringe & 25 ga x 1" (0.5 mm x 2.5 cm )
1
Needle
5 cc Syringes & 22 ga x 1½" (0.7 mm x 3.8 cm)
2
Needle
1
Fenestrated Drape
1
18 ga x 2 ¾" (1.3 mm x 67 mm) Needle
1
Needle Disposal Cup
®
1
SilvaSorb
Site Antimicrobial Dressing
1
SureSite Transparent Film Dressing
Device Description
The ICY Intravascular Heat Exchange Catheter ("ICY Catheter" or
"catheter") is a sterile, single-use, flexible catheter designed for
placement in the inferior vena cava from an insertion site in the
femoral vein. The ICY Catheter is to be connected to a ZOLL
single use disposable Coolgard 3000
Kit and the Coolgard 3000/ Thermogard XP System (both supplied
separately). An YSI-400 Temperature probe is required for the
operation of the Coolgard 3000 or Thermogard XP. A dilator and
guidewire are required for the percutaneous insertion of the ICY
Catheter. Three (3) Luers are available for infusion and sampling.
Infusion Port
Guidewire Port (brown)
Medial Port (white)
Proximal Port (blue)
The ICY catheter blood contact surfaces (tip, balloon, and shaft) are
treated with an anti-thrombotic Applause heparin coating.
Sterility
Ethylene oxide sterilized. The ICY Catheter is supplied sterile for
single use only and should not be resterilized. The package should
be inspected prior to use to ensure that the sterility barrier has not
been compromised.
Storage
Store between 20°C-25°C. Avoid freezing and excessive heat
above 40°C.
106477-001
Instructions for Use
Model IC-3893A/8700-0782-01
®
®
/Thermogard XP
Start-Up
Priming
Flow Rate
Volume
1700 ml/hr
0.5 cc
900 ml/hr
0.4 cc
1200 ml/hr
0.4 cc
Revision 6
Indications for Use
®
The ZOLL
ICY Intravascular Heat Exchange Catheter Model IC-
3893A, connected to the ZOLL Coolgard 3000/Thermogard XP
Thermal Regulation System, is indicated for use:
In cardiac surgery adult patients to achieve and/or maintain
normothermia during surgery and recovery/intensive care,
and
To induce, maintain and reverse mild hypothermia in
neurosurgery adult patients in surgery and recovery/intensive
care.
Contraindications
1.
The risks of the catheter are essentially those of a central line.
The catheter should not be used in patients for whom central
line placement is not indicated.
2.
Bleeding diathesis.
3.
Active sepsis.
4.
Infection or active bleeding at the site of catheter insertion.
5.
Patients with no vascular access or a vascular system that
will not accommodate a catheter, including patients with
vena cava filters or other implanted impediments to passage
of the catheter.
6.
Patients for whom the required temperature monitoring
cannot be established.
7.
Hypothermia is contraindicated in patients who have
hematological diseases that will be made worse with
hypothermia e.g. any disease that produces cryoglobulinemia,
any hemoglobinopathy in which hemolytic anaemia can be
precipitated by cold including Sickle Cell Disease or
Thalassemia.
8.
Not intended for pediatric or neonatal use.
Warnings and Precautions
Central venous catheterization should only be performed by well-
trained personnel well versed in anatomical landmarks and safe
technique. Personnel should also have knowledge of potential
complications.
SINGLE USE ONLY. The product is designed for single use
only. Do not resterilize or reuse. Do not reinsert, once removed
from the patient. Do not alter the catheter in any way. Maximum
use period: 4 days.
Potential risks with reuse of a single-use device include but are not
limited to:
Potentially life threatening infection
Toxic shock due to degradation of materials
Increased risk of thrombosis
Reduced heat exchange power
Device failures
WARNING: The ICY Catheter and Start-Up Kit could
potentially misconnect with other devices with small bore
connectors. Such connection errors could result in patient
injury or death.
ZOLL
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Summary of Contents for ZOLL ICY IC-3893A

  • Page 1 “catheter”) is a sterile, single-use, flexible catheter designed for Warnings and Precautions placement in the inferior vena cava from an insertion site in the femoral vein. The ICY Catheter is to be connected to a ZOLL Central venous catheterization should only be performed by well- ®...
  • Page 2: To Check The Integrity Of The Catheter

    15. Use only a 30 cc or smaller syringe for blood sampling. are not connected to an IV or other medical devices. 16. Use only the ZOLL suture tab and clip provided in the kit to The catheter should be positioned so that the distal tip of the prevent catheter damage.
  • Page 3 Model IC-3893A/8700-0782-01 Connect the syringe to the IN Luer of the catheter and only with the ZOLL Start Up Kits listed in Materials disconnect the OUT cap. Infuse 10 ml of saline – it should Required; they are not intended to connect to standard flow out the OUT Luer.
  • Page 4 Luers to catheter migration. make an air-free connection. 21. The ZOLL suture tab and clip can also be used as an WARNING: Failure to connect the Start-Up Kit additional attachment point. Ensure that catheter body is correctly to the catheter could result in catheter failure.
  • Page 5: Catheter Removal

    As the catheter is withdrawn, the balloons are compressed. Saline within the balloons must be free to pass ©2019 ZOLL Medical Corporation. All rights reserved. ZOLL and out of the balloon or the balloon will not deflate, making the ICY are trademarks or registered trademarks of ZOLL Medical catheter difficult to remove.
  • Page 6 ® Intravascular Heat Exchange Catheter (Custom Luer) Instructions for Use Model IC-3893A/8700-0782-01 Inspection Guidewire Instructions for Use Inspect the guidewire prior to use and discard if any Caution: Federal law (USA) restricts this device to sale and deformities are present. Guidewire placement should be use by or on the order of a physician.
  • Page 7 ® Intravascular Heat Exchange Catheter (Custom Luer) Instructions for Use Model IC-3893A/8700-0782-01 Medial Distal Proximal Detail view ICY IC-3893A Catheter Shaft Balloon 5 mm x 80.5 mm Balloon 8 mm x 80.5 mm Balloons 7 of 10...
  • Page 8 ® Intravascular Heat Exchange Catheter (Custom Luer) Instructions for Use Model IC-3893A/8700-0782-01 8 of 10...
  • Page 9 ® Intravascular Heat Exchange Catheter (Custom Luer) Instructions for Use Model IC-3893A/8700-0782-01 9 of 10...
  • Page 10 ® Intravascular Heat Exchange Catheter (Custom Luer) Instructions for Use Model IC-3893A/8700-0782-01 SilvaSorb 10 of 10...