Bard CROSSER, Instructions For Use Manual

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1
ENGLISH
C
ROSSER
™
Recanalization System
F
LOW
M
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
ROSSER
™ Recanalization System consists of a re-usable electronic
C
ROSSER
™ Generator, Foot Switch,
high frequency Transducer, the
F
LOW
M
ATE
®
Injector (optional) and single-use
C
ROSSER
™ Catheter. A
C
ROSSER
™
Catheter is connected to the electronic
C
ROSSER
™ Generator through the Transducer. The Foot Switch is used to
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
ROSSER
™ Catheter. During use (or
activation of the
C
ROSSER
ŒVDOLQHLVUHTXLUHGWRÀXVKWKH C
ROSSER
™ Catheter. A
F
LOW
M
ATE
®
Injector or other
injection system is required.
The
F
LOW
M
ATE
®
Injector is a sterile saline injector for use as an accessory to the
C
ROSSER ™ Recanalization
System. The
F
LOW
M
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
LOW
M
ATE
®
Injector to allow
connection to the
C
ROSSER ™ Generator. The
F
LOW
M
ATE
® ,QMHFWRULVSURJUDPPHGWR¿UVWVWDUWWKH F
LOW
M
ATE
®
Injector, and then the
C
ROSSER ™ Generator each time the Foot Switch is depressed.
Figure 1 – The
C
ROSSER
™ Recanalization System
Figure 2 -
F
LOW
M
ATE
®
Injector Drawings
C
ROSSER
™
Generator
Transducer
C
ROSSER
™
Catheter
Irrigation Lumen
F
LOW
M
ATE
®
Injector
5 Caster. (IV Pole
not provided)
Foot Switch
(D) Advance / Withdraw Buttons
(B) Footswitch Jumper Cable (to
C
ROSSER
™ Generator) Right Side of
F
LOW
M
ATE
®
Injector
(C) Footswitch connection Bottom of
F
LOW
M
ATE
®
Injector
C
Top of
F
LOW
M
ATE
®
Injector
D
$)URQW3DQHOVHHDOVR¿JXUH
Front of
F
LOW
M
ATE
®
Injector
A
B