Osprey Medical CMW-XX Bedienungsanleitung Seite 2

events occur, the user may continue to use the disposables for contrast injection
without modifications. A security failure will not cause an inadvertent or
independent contrast injection. If a security failure occurs, please contact Osprey
Medical.
HOW SUPPLIED
The Display is provided non-sterile.
EU Declaration of Conformities are available upon request.
STORAGE
Storage conditions for the Display:
Temp = -20°C (-4 F) to 60°C (140 F)
° °
Humidity = 10% to 85%, noncondensing
Pressure = 50 kPa to 106 kPa
MAINTENANCE and REPAIR
Maintenance is not required. Contact Osprey Medical if Display repairs are
required.
DISPOSAL
The Display should not be disposed of by the user. Contact Osprey Medical to
arrange for shipment of the Display for disposal.
CLEANING DISPLAY
Non-disposable components (display, power cord) should be cleaned in
accordance with hospital policy and procedure with Super Sani-Cloth (or
equivalent) or a cloth dampened with 70/30 isopropyl alcohol. Avoid use of
solvents or abrasive cleaners which may damage the plastic portion of these
components or the touch screen.
OPERATING ENVIRONMENT & 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
Pressure = 60 kPa to 106 kPa
The system is not intended be used near active high frequency surgical
equipment or with magnetic resonance imaging (MRI) where the intensity of
electromagnetic disturbances is high.
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 Display but
physicians should be thoroughly familiar with the Display and compatible
disposables, and supporting material including all product labeling. Physicians
may contact Osprey Medical to request training.
DIRECTIONS FOR USE
System Overview
The touchscreen Display allows user input for desired contrast use monitoring,
per specific individual case. Following input of monitoring parameters, during a
case the Display shows Injection Volume (individual injection mL), Cumulative
Volume (total injected mL), as applicable a physician selected Threshold Volume
(maximum target dose) and a soft touch field to toggle between % contrast in
injection syringe (e.g. 95% contrast indicates a 5% saline/other mix), % of
Contrast Saved on last injection & % Contrast Saved (Avg). When "0" is entered
as the threshold (no threshold) the threshold gauge is not displayed. If the case
is a DyeTect case % contrast saved fields are not applicable and therefore not
selectable by the user. Note that the ON/OFF to contrast savings indicator icon in
the upper left corner of the screen is only displayed when being used with the
DyeVert Plus Module.
Threshold Case Screen
The Smart Syringe and associated disposable (DyeVert Plus Module, DyeVert
Plus EZ Module or DyeTect Pressure Module) have two LEDs to provide user
feedback.
 Solid Green (active for 10 seconds) indicates injections will be counted
towards cumulative volume
 Flashing Yellow indicates system is paused and injections will not be counted
towards cumulative volume
The Pause Button allows the user to Pause the system to suspend contrast
accounting.
Pause
Button
The Display is not intended for indefinite continuous use and should be powered
down periodically (recommend daily).
The disconnect component for the Display is the plug for the DC power supply
that inserts into the receptacle (outlet) for mains power. To disconnect the
device, remove the plug from the receptacle. The Display should be located such
that it is easy to unplug from the receptacle.
1. Display Set-up and User Settings
a. Remove the Display and the DC power supply from protective packaging.
b. Insert power jack (plug) of the DC power supply into the receptacle of the
Display. Manually tighten the ring nut onto the socket to prevent inadvertent
disconnect.
c. Mount the Display to a standard IV Pole using the integral clamp on the
back of the Display. Verify that the IV pole is stable when the Display is
mounted to it.
d. Plug Display electric power cord into DC power supply and an appropriate
outlet (100-240V-0.5A(0,5A) 50-60Hz..
e. Push Power-On button and the Home Screen (Main Menu) will display.
Triple Toggle
Pause
Button
8161-N Jan 2020