•
When mating the MDU onto the Catheter Assembly Cartridge, do not bend or kink the
Dispersion Wire. To do so could cause damage to the device or patient injury.
•
Slowly withdraw the device through the treatment area after Dispersion Wire activation. A
draw rate of approximately 1-2 mm/second is recommended while simultaneously infusing
fluid.
•
Potential fatigue failure of the ClariVein
®
IC Dispersion Wire may occur with prolonged
activation of the device, which could result in device breakage.
•
Prior to the Dispersion Wire rotation activation, confirm that the Catheter Assembly Cartridge
is securely mated in Position 2 in the MDU to avoid damage to the device and/or patient injury.
•
Do not advance the Catheter Assembly when the Catheter Assembly Cartridge is mated to the
MDU and is in Position 2.
•
Upon completion of the infusion procedure, prior to removal of the ClariVein
®
IC, move the
Catheter Assembly Cartridge to Position 1 in the MDU to avoid damage to the device and/or
patient injury.
•
The Catheter Assembly and Motor Drive Unit cannot be separated after the Catheter Assembly
is moved to Position 2.
ADVERSE EVENTS
Potential adverse events that might be encountered during a peripheral vasculature infusion
procedure using the ClariVein® IC are similar to those associated with any interventional
procedure and include, but are not limited to, the following:
1. Abrupt thrombosis and occlusion of the treated vessel
8. Embolization
2. Bleeding from the site of access
9. Reaction to infused substances
3. Vascular rupture and perforation
10. Pain
4. Vascular dissection
11. Pseudoaneurysm
5. Hemolysis
12. Hypotension, Hypertension
6. Hematoma
13. Infection at the access site
7. Neurological deficits including stroke
14. Death
HOW SUPPLIED
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Vascular Insights
™
representative. Do not use if labeling
is incomplete or illegible.
Handling and Storage
Store in cool, dry place.
DISPOSAL INSTRUCTIONS
After use, dispose of the products used in the procedure per institutional protocol.
Please note
that the ClariVein
®
MDU unit contains a 9V DC battery, which is
not
intended for
removal.
As such, the entire product, including the MDU is considered an infected medical
device and is fully disposable as medical/biohazard waste and is
not
intended to be included in
used electronic equipment recycling programs
.
____________________________________________________________________
ClariVein
®
is a registered trademark of Vascular Insights
™
, LLC in the United States.
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