Bard CROSSER Instructions For Use Manual

ENGLISH
C
ROSSER
Recanalization System
™
F M ®
LOW ATE
Injector - Manual of Operations
Instructions for Use
Warning! Carefully read all instructions prior to use. Observe all warnings and precautions noted
throughout these instructions. Failure to do so may result in a hazardous situation.
Caution! Federal law restricts this device to sale by or on the order of a physician.
Description
The C ™ Recanalization System consists of a re-usable electronic C
ROSSER
high frequency Transducer, the F M ®
LOW ATE
Catheter is connected to the electronic C
ROSSER
activate the system. The C
ROSSER
™ Generator and Transducer convert AC power into high frequency mechanical
vibrations which are propagated through a core wire to the metal tip of the C
activation of the C
ROSSER
injection system is required.
The F M ® Injector is a sterile saline injector for use as an accessory to the C
LOW ATE
System. The F M ®
LOW ATE
Injector is designed to infuse saline at a rate of 0.3ml/sec at a maximum of 200 PSI.
The Injector is operated by a Foot Switch. A jumper cable is supplied with the F
connection to the C ™ Generator. The F
ROSSER
Injector, and then the C
ROSSER
™ Generator each time the Foot Switch is depressed.
Figure 1 – The C
Transducer
C
ROSSER ™
Catheter
Irrigation Lumen
ROSSER ™ Generator, Foot Switch,
Injector (optional) and single-use C ™ Catheter. A C
ROSSER
™ Generator through the Transducer. The Foot Switch is used to
ROSSER ™ Catheter. During use (or
C ™ Catheter. A F
ROSSER LOW
ROSSER
M ®
LOW ATE
M ®
LOW ATE
ROSSER ™ Recanalization System
Foot Switch
A
ROSSER
™
M ®
ATE
Injector or other
™ Recanalization
Injector to allow
F M ®
LOW ATE
C
ROSSER
™
Generator
Right Side of F
F M ®
LOW ATE
Injector
5 Caster. (IV Pole
Bottom of F
not provided)
1
®
Figure 2 - F M
LOW ATE Injector Drawings
®
Front of F M
LOW ATE
Injector
B
®
M (B) Footswitch Jumper Cable (to C
LOW ATE Injector
C
®
M
LOW ATE
Injector
D
®
Top of F M
LOW ATE Injector
ROSSER ™ Generator)
(C) Footswitch connection
(D) Advance / Withdraw Buttons