Osprey Medical DyeVert Power XT Instrucciones De Uso

DyeVert™ Power XT Contrast Reduction System
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
The Osprey Medical DyeVert ™ Power XT Contrast Reduction (DyeVert Power
XT) System is compatible with power injectors used in angiographic procedures
using contrast media. and provides fluid pathway resistance modulation such
that excess contrast volume (i.e. contrast for diagnostic or therapeutic purposes
that is without clinical benefit) is minimized in the patient's vasculature and total
contrast media dosage reduction occurs; while maintaining adequate image
quality. Age, diabetes, moderate and severe chronic kidney disease (CKD, renal
insufficiency) and heart failure on presentation are leading factors
when considering renal protection measures such as contrast minimization tools
and processes.
The DyeVert Power XT is a disposable, single-use sterile device consisting of a
diversion line and two catheter size-dependent Diversion Valves. The device
is positioned between the power injector's most proximal connector and the
angiographic catheter via the DyeVert Power XT Stopcock. Each of the Diversion
Valves responds to the contrast injection pressure and modulates the amount of
contrast diverted. The diverted contrast is collected in the Contrast Collection
Bag.
The DyeVert Power XT has been designed for use with Luer fittings
demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for
syringes, needles and certain other medical equipment". Use of catheters and
power injectors beyond those listed below have not been substantiated.
Diagnostic
4F
5F
6F
-
Power Injectors
ACIST CVi ® Contrast Delivery System
MEDRAD ® Avanta™ Fluid Management System
MODEL NUMBER
Model Number Contrast Viscosity Range at 37 C
HV-POWER-A-EU 4.7 to 11.8 cps (mPa*s)
INTENDED USE
The DyeVert ™ Power XT Contrast Reduction System is intended to reduce the
amount of contrast media administered to the patient during angiographic
procedures using automated injections of contrast media.
Clinical evidence has demonstrated that contrast media can be toxic to the
kidneys, leading to contrast induced nephropathy (CIN).
CONTRAINDICATIONS
The DyeVert Power XT System is not intended to be used during manual
contrast injections.
WARNINGS
For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocess or
re-sterilization may create a risk of patient infection which could lead to injury,
illness or death.
The DyeVert Power XT System is to be used with t power injector flowrates set to
a minimum of 3mL/s.
Do not use if product packaging appears compromised or damaged.
Not for use with catheters not listed in the IFU or contrast media outside of the
viscosity range listed in the IFU.
Bypass the DyeVert Power XT System for Aortograms, LV grams, and other
structural images.
Refer to the contrast media Labeling for dosage recommendations, warnings,
contraindications, detail of reported adverse event types and detailed directions
for use associated with contrast administration.
Refer to the applicable power injector instruction manual for system warnings,
contraindications and directions for use.
Guide Guide w/Rx
- -
- -
6F 6F
7F 7F
If delivering drugs through the power injector stopcock, bypass DyeVert Power
XT to ensure full dosage is delivered.
PRECAUTIONS
In the event the device malfunctions or changes in performance that is not
expected, discontinue use immediately and report experience to Osprey Medical
representative. If the incident is considered reportable (e.g. serious) by the
regulating authority, please ensure the incident is also reported to the qualifying
regulatory authority.
Using the DyeVert Power XT off-label may result in undesired affects such as
poor imaging or lack of contrast reduction.
The DyeVert Power XT is designed to be used with non-diluted, room
temperature (non-warmed) contrast media only.
As with any tubing used to inject contrast media into a patient, care should be
taken to ensure all air has been removed from the lines, prior to injection, to
avoid air embolization.
Use only light tapping, if necessary, to remove air while priming the DyeVert
Power XT. Do not use tools such as hemostats or other instruments.
Be cautious to not over-tighten luer connections when connecting the DyeVert
Power XT Stopcock.
If using saline flush or automated infusion functions of the power injector, bypass
DyeVert Power XT to ensure full rate is delivered.
If dampening in the amplitude of the pressure wave occurs when the DyeVert
Power XT stopcock in in the "ON" position, user should bypass the DyeVert for
dampening correction.
The graduations on the Contrast Collection Bag are approximate and are not
intended for estimating diversion volume measurement. In addition to contrast,
the Contrast Collection Bag may contain saline, blood or other fluids.
POTENTIAL ADVERSE EVENTS
Possible adverse effects include but are not limited to: air embolism and
infection.
HOW SUPPLIED
The DyeVert Power XT is disposable and is supplied sterile. DyeVert Power XT
has been sterilized with ethylene oxide (EO).
STORAGE
For optimal battery life, store the DyeVert EZ Disposable Kit between +10°C and
+25°C (50°F and 77°F) and not exceeding +30°C (86°F).
MAINTENANCE and REPAIR
Maintenance is not required.
DISPOSAL
Discard according to hospital procedures.
OPERATING CONDITIONS
The system is intended to be used in a standard hospital Cath lab environment.
PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable of Cath lab procedures,
techniques and contrast media usage.
No additional special skills or training is required to operate the system, but
physicians should be thoroughly familiar with the DyeVert Power XT Contrast
Reduction System supporting material including all product labeling. Physicians
may contact Osprey Medical to request training.
DIRECTIONS FOR USE
A. Assemble and Prime
1) Prime power injector as directed in the applicable Manual.
2) Introduce DyeVert Power XT and the Contrast Collection Bag into the sterile
field per normal procedure.
3) Attach the female luer of DyeVert Power XT stopcock to the male luer at the
end of the power injector line. (See Figure 1)
8285-H Jan 2020