Vascular Insights CLARIVEIN IC Instructions For Use Manual Download Page 8

 

Caution

: A kink could cause damage to the device or patient injury. 

Caution:

 Do not exert excessive force when withdrawing or advancing the 

catheter. If resistance is encountered determine if remedial action is necessary. 
Failure to do so may result in device damage or patient injury. 
 

2.

 

Adjust the Dispersion Wire rotation speed as desired.  

3.

 

Continue the infusion procedure.  

4.

 

After approximately one third of the total treatment is complete, check to determine that 
desired agent dispersion has been achieved. If adequate dispersion has not been achieved, 
it may be necessary to repeat the infusion and dispersion of the agent.  

NOTE:

 Resheath the Dispersion Wire by moving the Guide Wing from Position 2 to 

Position 1 in the Mating Alignment Channel prior to advancing the Dispersion Wire Tip 
to the desired position and repeat Procedural Steps 1-3. 

5.

 

With approximately half of the vessel’s targeted infusion length remaining, slide the 
access device to the most proximal end of the catheter assembly.  

6.

 

While the catheter is still within the vessel, use vascular imaging to verify that the desired 
outcome has been achieved.  

7.

 

Re-sheath the Dispersion Wire Tip by moving the Guide Wing to Position 1 before 
removing catheter from the patient. 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 Guide Wing’s Cartridge to the mating alignment 
channel Position 1. (Figure 4) 

NOTE:

  Moving the Guide Wing into mating alignment channel Position 1 will 

re-sheath the Dispersion Wire Tip and prevent the wire from rotating while 
removing device from patient. 

NOTE:

  The Catheter Assembly 

cannot

 be separated from the MDU. 

 
Post-Procedure: 

1.

 

Dispose of the products and packaging per institutional protocol. 

2.

 

Institute appropriate post-procedural patient care. 
 

ELECTROMAGNETIC COMPATABILITY 

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put 
into service according to the EMC information provided in the accompanying documents. Portable and 
Mobile RF communications equipment can effect medical electrical equipment. 
 

WARNING 

The use of accessories, other than those specified, may result in increased emissions or 

decreased immunity of the equipment. 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. 
 
 
 
 
 
 
 

____________________________________________________________________ 

ClariVein

®

 is a registered trademark of Vascular Insights

, LLC in the United States.    

           Page 8 

 

 

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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