Vascular Insights CLARIVEIN IC Instructions For Use Manual Download Page 6

 

Figure 3: Catheter Assembly with Check Valve and Syringe

 

 
 
 
 
 
 
 
 
 
 

 

14. Check Valve 
15. Syringe 5 mL 

 

 
Catheter Assembly Positioning 

1.

 

Utilize vascular imaging guidance (e.g. ultrasound) to thread the ClariVein’s coaxial 
Catheter Sheath and Dispersion Wire through the access device to the desired position 
within the peripheral vasculature. 

Joining Catheter Assembly to the Motor Drive Unit (MDU):

 

1.

 

Maintain position of the catheter and dispersion tip within the peripheral vessel.  

2.

 

Hold the Guide Wing and advance the MDU onto the Catheter Assembly’s Cartridge for 
initial mating in the alignment channel Position 1 (Figure 2, Item 7; Figure 4). Exercise 
care 

not

 to bend or kink the proximal end of the catheter.  

NOTE:

 Once placed into Position 2, the Catheter Assembly is 

not removable

 from the 

MDU. 

3.

 

Using vascular imaging guidance confirm that the Dispersion Wire Tip remains in 
desired position. Adjust as needed. 

4.

 

Place the Cartridge in the final position on the MDU by simultaneously advancing the 
MDU while applying slight pressure on the Syringe Locking Support. The cartridge will 
snap into alignment Position 2. 
NOTE: The electrical circuit is now armed and the Dispersion Wire Tip is now 

unsheathed

.  

5.

 

Snap the syringe into the MDU Syringe Locking Support and ensure it is fully engaged. 
(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. 

 

 

 

 

 

 

15

 

14

 

____________________________________________________________________ 

ClariVein

®

 is a registered trademark of Vascular Insights

, LLC in the United States.    

           Page 6 

 

 

Summary of Contents for CLARIVEIN IC

Page 1: ...is a specialty infusion catheter with 360 Rotatable Dispersion Wire connected to a proximally located integral battery powered Motor Drive Unit MDU The MDU includes the Speed Selector handle grip and...

Page 2: ...ices and solutions intended for use including warnings cautions potential side effects and contraindications Before using ClariVein IC verify proper function and integrity of the device Refer to packa...

Page 3: ...ral 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 occ...

Page 4: ...hnique to carefully remove the tray from the pouch and the contents from the tray 3 Inspect the device to be certain there are no visible signs of damage Do not use if contents are damaged 4 Remove Ba...

Page 5: ...ve Unit 7 Mating Alignment Channel 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 6: ...Once placed into Position 2 the Catheter Assembly is not removable from the MDU 3 Using vascular imaging guidance confirm that the Dispersion Wire Tip remains in desired position Adjust as needed 4 Pl...

Page 7: ...Wire is unsheathed Procedural Steps 1 Slowly withdraw the device through the treatment area while simultaneously infusing the physician specified agent Recommended technique o Depress the syringe plu...

Page 8: ...tient Disable the MDU a Disengage the syringe from the Syringe Locking Support on the MDU Figure 2 9 b Rotate the catheter assembly to unlock from Position 2 Figure 4 c Move the Catheter Assembly Guid...

Page 9: ...Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 6kV Contact 8kV Air 6kV Contact 8kV Air Floors should be wood concrete or ceramic tile If floors are synthetic the r h sh...

Page 10: ...r can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the ClariVein IC as recommended below according to the max...

Page 11: ...ility has been foreseen or was foreseeable even if Vascular Insights has been advised of the possibility thereof if and to the extent that Vascular Insights notwithstanding the foregoing is liable for...

Page 12: ...Sterilized utilizing EO Consult instructions for use Keep away from rain BF Applied part Fragile handle with care Do not resterilize Do not use if package damaged Do not reuse ________________________...

Page 13: ...ghts com 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 ___________________________...

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