Instructions for Use - COPILOT Bleedback Control Valve
Indications, Contraindications, Warnings, Precautions, Adverse Events
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications
The COPILOT Bleedback Control Valve is indicated for maintaining a seal
around diagnostic/interventional devices with an outside diameter < .096"
(2.44mm) during interventional procedures.
Contraindications
The COPILOT Bleedback Control Valve is not intended for use with pressure
injections > 400 psi.
Warnings
This device is intended for one time use only. Do NOT resterilize and/or
reuse.
Do not inject any fluid if air bubbles are visible within the COPILOT Bleedback Control Valve.
To prevent damage to a balloon, it must be completely deflated during advancement/withdrawal through the COPILOT Bleedback Control Valve.
Failure to depress the cap prior to inserting a guide wire introducer could cause seal damage resulting in leakage and/or particulate embolization.
Failure to open the BBC seal and the clamp seal prior to inserting/withdrawing a diagnostic/interventional device could cause damage to the diagnostic/interventional device.
Power injection at pressures greater than 400 psi could result in leakage or detachment of components.
Care should be taken to avoid overtightening the clamp seal, as this may compromise the integrity of the diagnostic/interventional device lumen.
Precautions
Prior to use, inspect the COPILOT Bleedback Control Valve for any damage.
Do not use a damaged COPILOT Bleedback Control Device.
Please see specific product Instructions For Use for additional product information.
LT2922560
