Directions For Use - Osprey Medical Smart Monitor Instrucciones De Uso

PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable with Cath lab procedures, techniques and
contrast usage.
No additional special skills or training is required to operate the Smart Monitor but physicians
should be thoroughly familiar with the Smart Monitor and compatible disposables, and
supporting material including all product labeling. Physicians may contact Osprey Medical to
request product review.

DIRECTIONS FOR USE

The Smart Monitor provides the user access to the Osprey Medical Contrast Monitoring app
interface, eGFR calculator app and iOS setting app. The user can choose the Contrast
Monitoring App interface style. The eGFR calculator downloaded is provided by the National
Kidney Foundation (copyrighted 2015). Updates to the Contrast Monitoring app, eGFR calculator
app and iOS setting app is controlled through software version updates.
Contrast Montoring App Overview
The Contrast Monitoring app main screen provides a pictorial representation fo the DyeVert Plus
Disposable Kit or the DyeVert Plus EZ Disposable Kit. If using the DyeTect Contrast Monitoring
Disposable Kit, the Smart Monitor will automatically recognize the disposables upon selection of
"New Case".
The Contrast Monitoring app on the Smart Monitor allows the user to enter a physician
specified threshold volume for the intended maximum contrast volume administered to the
patient.
During a case the Smart Monitor displays
 "Last Injection, mL" (volume of last individual injection)
 "Cumulative, mL" (total volume injected)
 Triple toggle for:
- If applicable, "Contrast Saved, %" (% contrast saved on last injection)
- If applicable, "Contrast Saved (Avg) %" (Cumulative % of contrast saved during
procedure)
- "Contrast in Syringe, %" (e.g. 90% indicates 90% contrast & 10% saline/other mix)
 As applicable "Remaining Threshold" (contrast volume remaining relative to the physician-
specified threshold) with graphical threshold indicator. When '0' is entered for threshold the
remaining threshold & graphical threshold indicator is not displayed.
Below is one of the optional user interfaces for the Contrast Monitoring app case screen. Swipe
left during case for alternative option.
CASE SCREEN
The Smart Monitor is not intended for indefinite continuous use and should be powered down
periodically (recommend weekly). To power down the Smart Monitor depress and hold the
"On/Off" button on the end of the Smart Monitor. Confirm power down by swiping the screen
when prompted.
The Smart Monitor connects to the main power supply receptacle via a DC power supply cord
and plug. To disconnect the Smart Monitor, remove the plug from the receptacle. The Smart
Monitor should be located such that it is not difficult to unplug from the receptacle.
Smart Monitor Set-up and User Settings
- Remove the Smart Monitor and the DC Power Supply from protective packaging.
- Mount the Smart Monitor to a standard IV Pole (19mm to 38mm diameter) or horizontal
bed rail (10mm x 25mm) using the integral clamp on the back of the Smart Monitor.
- Verify that the IV pole is stable when the Smart Monitor is mounted to it.
- Plug Smart Monitor DC power supply into an appropriate outlet. (100-240V-0.5A(0,5A)
50-60Hz.
- Push Power On button (end of Smart Display) and release.
- Push the Home Button and enter "000000" as the passcode to access the Smart
Monitor.
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