Osprey Medical DyeVert Power XT Instructions For Use Manual

DyeVert™ Power XT Contrast Reduction System
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
The Osprey Medical DyeVert ™ Power XT Contrast Reduction (DyeVert Power
XT) System is a compatible device with the ACIST CVi® Contrast Delivery
System (ACIST CVi), 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 ACIST CVi stopcock 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 the ACIST CVi and with
Luer fittings demonstrated to comply with ISO 594 "Conical fittings with a 6% luer
taper for syringes, needles and certain other medical equipment"; and the
catheter configurations listed below. Use of catheters beyond those listed has not
been substantiated.
Diagnostic
4F
5F
6F
-
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 with the ACIST CVi.
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 the ACIST CVi System only
with injections flowrate 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 Aortagrams, 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 ACIST CVi System instructions manual for system warnings,
contraindications and directions for use.
PRECAUTIONS
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.
Guide Guide w/Rx
- -
- -
6F 6F
7F 7F
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 KVO function on ACIST CVi, bypass DyeVert Power XT to ensure full
rate is delivered.
If delivering drugs through the ACIST stopcock, bypass DyeVert Power XT to
ensure full dosage 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 accurate 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
No special storage conditions required.
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 ACIST CVi System as directed in the ACIST CVI System 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 of the
ACIST CVi stopcock. (See Figure 1)
8285-E