Osprey Medical DyeVert Power XT Gebrauchsanweisung

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 Smart Bag. The digital
display of diverted contrast volume in the Smart Bag is accurate to ±5 mL (< 25
mL), ±20% (25 mL ≤ x ≤ 90 mL).
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 Guide
4F -
5F 5F
6F -
- -
POWER INJECTOR COMPATIBILITY
The DyeVert Power XT has been designed for use with any power injector
capable of injecting at an injection flow rate > 3 mL/s.
MODEL NUMBER
Model Number Contrast Viscosity Range at 37 C
HV-POWER-A-EU 4.7 to 11.8 cps (mPa*s)
CLASSIFICATION
• The Smart Bag of the DyeVert Power XT Disposable Kit is Internally Powered
• Degree of protection against electric shock: Type CF applied part
• Equipment not suitable for use in the presence of flammable mixtures
APPLIED PARTS
DyeVert Power XT Module and Smart Bag
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 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.
Guide w/Rx
-
-
6F
7F
Refer to the applicable power injector instruction manual for system warnings,
contraindications and directions for use.
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 function of the power injector, bypass DyeVert Power XT.
In addition to contrast, the Smart Bag may contain saline.
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 Power XT 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 the DyeVert ™ Power XT with Smart Bag according to hospital
procedures. The contrast in the Smart Bag should not be reused.
The Smart Bag has been designed to comply with battery waste regulations. At
the end of device use the alkaline battery inside is 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.
OPERATING CONDITIONS
The system is intended to be used in a standard hospital Cath lab environment.
MASS of DEVICE
DyeVert Power XT Module
Smart Bag
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 Smart 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)
61g
117g
8300-B August 2020