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Vascular Insights CLARIVEIN IC Instructions For Use Manual

Infusion catheter
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®
CLARIVEIN
IC, INFUSION CATHETER
WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your company representative. Inspect prior to use to verify that
no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device failure,
which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization
may also create a risk of contamination of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.
DEVICE DESCRIPTION
IC is a specialty infusion catheter with 360˚ Rotatable Dispersion Wire connected
®
The ClariVein
to a proximally located integral battery powered Motor Drive Unit (MDU). The MDU includes
the Speed Selector, handle grip and Syringe Locking Support features to facilitate physician-
controlled infusion of the selected agent. The ClariVein
microintroducer. Utilizing vascular imaging, the coaxial Catheter Sheath with Dispersion Wire is
navigated through the vasculature to the treatment site. Fluid delivered through the Catheter
Assembly's Check Valve and Injection Port surrounds the Dispersion Wire and exits via an
opening at the distal end of the catheter. The ClariVein
capital equipment. It is fully disposable.
CONTENTS
1
ClariVein
1
Syringe 5 mL
INDICATIONS FOR USE
®
The ClariVein
IC is indicated for infusion of physician-specified agents in the peripheral
vasculature.
INTENDED USE
®
The ClariVein
IC is intended for the infusion of physician-specified agents in the peripheral
vasculature.
____________________________________________________________________
®
ClariVein
is a registered trademark of Vascular Insights™, LLC in the United States.
®
IC
®
IC is introduced through a
®
IC has no user serviceable parts or
Page 1

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Summary of Contents for Vascular Insights CLARIVEIN IC

  • Page 1 IC is indicated for infusion of physician-specified agents in the peripheral vasculature. INTENDED USE ® The ClariVein IC is intended for the infusion of physician-specified agents in the peripheral vasculature. Page 1 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 2 • Utilize vascular imaging such as ultrasound to confirm that the catheter tip is in the desired location before activation of Dispersion Wire rotation. Page 2 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.

  • Page 3: Adverse Events

    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.

  • Page 4: Operational Instructions

    Caution: If leak is detected, reconfirm syringe and Check Valve connections. Do not use if a leak persists. 8. Fill the 5 mL syringe with agent to be infused. (Figure 3, Item 15) Page 4 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 5 11. Mating Alignment Channel Position 1 Position 2 8. Speed Selector 12. Battery Terminal Insulator Tab 9. Syringe Locking Support 13. Green Indicator Light 10. Trigger Page 5 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 6 (Figure 2, item 9) 6. Utilizing vascular imaging guidance, reconfirm that the Dispersion Wire Tip remains in desired position within the vessel. Adjust as needed. Page 6 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 7 Orient the Catheter/Wire to maintain a straight position and to avoid kinking or creating an acute bend between the vascular access site and MDU. Page 7 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.

  • Page 8: Electromagnetic Compatability

    The equipment should not be used adjacent to other equipment; and if adjacent to the equipment should be observed to verify normal operation in the configuration in which it will be used. Page 8 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 9 Power Frequency 3A/m 3A/m Power frequency magnetic fields should be 50/60Hz that of a typical commercial or hospital Magnetic Field IEC 61000-4-8 Page 9 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.

  • Page 10: Warranty

    Vascular Insights™ within one (1) year from the date that the instrument was delivered by Vascular Insights™ or its authorized vendor to the end user who purchased the instrument for his/her/its or his/her/its employees’ use. This warranty is the...
  • Page 11 Vascular Insights™ and any affiliate shall in no event be liable to the customer or any other person for any direct, indirect, incidental, consequential, exemplary, special or punitive damages or losses...

  • Page 12: Definitions Of Symbols

    Keep away from rain BF, Applied part Fragile, handle with care Do not resterilize Do not use if package damaged Do not reuse Page 12 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.
  • Page 13 US Patents 7,862,575, 7,967,834, 8,465,508, 8,696,645 and other United States and foreign patents pending. © 2016 Vascular Insights™, LLC. All rights reserved. IFU-001 Rev. B Page 13 ____________________________________________________________________ ® ClariVein is a registered trademark of Vascular Insights™, LLC in the United States.

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