8287-E Jan 2020
EU Declaration of Conformities are available upon request.
STORAGE
For optimal battery life, store the DyeVert EZ Disposable Kit b10°C and
+25°C (50°F and 77°F) and not exc30°C (86°F).
MAINTENANCE and REPAIR
Maintenance is not required.
DISPOSAL
Discard Smart Syringe, DyeVert Plus EZ Module with Contrast Collection Bag
and single-use contrast source according to hospital procedures. The contrast
in the Contrast Collection Bag should not be reused.
The Smart Syringe and DyeVert Plus EZ Module have been designed to comply
with battery waste regulations. At the end of device use, the alkaline batteries
are inside an infected medical device. In this instance, the Batteries Directive
(2006/66/EC), the WEEE Directive and Federal Law DO NOT apply to the
collection or waste treatment of the alkaline battery.
Follow local governing ordinances regarding disposal. Do not incinerate as the
enclosed batteries may explode at excessive temperatures.
OPERATING CONDITIONS
The system is intended to be used in a standard hospital cath lab environment
under the following conditions:
Temperature: 10°C to 27°C (50°F to 80°F)
Relative humidity 0% to 85%, noncondensing
The system is not intended be used near active high frequency surgical
equipment where the intensity of electromagnetic disturbances is high.
MASS of DEVICES
DyeVert Plus EZ Module with Contrast Collection Bag 135g
Smart Syringe
44g
PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable with Cath lab procedures,
techniques and contrast media usage.
No additional special skills or training are required to operate the system, but
physicians should be thoroughly familiar with the DyeVert Plus EZ Contrast
Reduction System supporting material including all product labeling. Physicians
may contact Osprey Medical to request product review.
DIRECTIONS FOR USE
System Overview
The DyeVert Plus EZ Disposable Kit is for use with the Monitor through wireless
communication. The system allows user input and monitoring of cumulative
volume, injection volume and user inputted threshold. A user selectable triple-
toggle field allows for display of either the % contrast in Smart Syringe, %
Contrast Saved for each injection or % average contrast saved throughout the
case. The system with the DyeVert Plus EZ Module allows contrast modulation to
the patient resulting in a total contrast volume savings.
Threshold Case Screen
No Threshold Case Screen
Modulation System
A. Assemble and Prime Manifold
Note: It is recommended to leave all battery pull tabs in the disposable devices
until all priming is complete and the case is ready to begin. This will ensure
maximum battery life and performance throughout the case.
1) Introduce disposables into sterile field per normal procedure.
2) Attach contrast collection bag to DyeVert Module Reservoir.
3) Attach contrast source line to top of DyeVert Module Reservoir.
4) Attach DyeVert contrast line to contrast port on manifold. Ensure swivel luer
connection is tightened and securely attached to manifold.
5) Attach DyeVert T-Connector to manifold.
6) Turn DyeVert 1-Way
Stopcock to “OFF” (parallel to manifold) to isolate the
DyeVert Module Reservoir.
Triple Toggle
Attach contrast line
to luer fitting
DyeVert
Contrast
Line
T-Connector
Attach
Contrast
Collection
Bag
Triple Toggle
