Osprey Medical DyeVer Plus EZ Instructions For Use Manual

DyeVert™ Plus EZ Disposable Kit
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
™
The Osprey Medical DyeVert Plus EZ Contrast Reduction System is a
compatible device to manual contrast injections and provides fluid pathway
resistance modulation such that excess contrast volume (i.e. contrast that is not
needed for diagnostic or therapeutic purposes) is minimized in the patient's
vasculature and total contrast agent volume reduction occurs; while maintaining
adequate image quality. Age, diabetes, moderate and severe chronic kidney
disease and heart failure on presentation are leading factors for when to consider
renal protection measures such as contrast minimization tools and processes.
The DyeVert Plus EZ Contrast Reduction System consists of the:
1) Display (provided separately) and
2) DyeVert Plus EZ Disposable Kit.
The Display may be either the Osprey Medical Contrast Monitoring Display or the
Osprey Medical Smart Monitor. The DyeVert Plus EZ Disposable Kit consists of
the Smart Syringe and DyeVert Plus EZ Module.
The DyeVert Plus EZ Disposable Kit is intended to be used with the Display to
allow monitoring and display of contrast volumes manually injected. Volumes are
displayed and compared to physician entered contrast usage thresholds during
angiographic procedures.
The DyeVert Plus EZ Module has been designed for use with standard injection
syringes and manifolds with Luer fittings that have been 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.
Utilization of catheters beyond those listed has not been substantiated.
Diagnostic Guide
4F -
5F 5F
6F 6F
- 7F
MODEL NUMBER SELECTION- Disposables
Model Number Contrast Viscosity Range at 37 C
HV-EZ-XXX-EU 8.1 to 11.8 cps (mPa*s)
HV-EZ-XXX-EU-10
LV-EZ-XXX-EU 4.7 to 8.1 cps (mPa*s)
LV-EZ-XXX-EU-10
Note: "-XXX" identifier is denoted as available syringe
configurations
CMS CLASSIFICATION
• The DyeVert Plus EZ 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
Smart Syringe, DyeVert contrast line and T-Connector of the DyeVert Plus EZ
Module and Contrast Collection Bag.
INTENDED USE
The DyeVert™ Plus EZ Contrast Reduction System is intended to reduce the
amount of contrast media administered during procedures requiring the injection
of contrast media. Clinical evidence has demonstrated that contrast media can
be toxic to the kidneys, leading to Contrast Induced Acute Kidney Injury.
CONTRAINDICATIONS
Not for use with power injectors.
WARNINGS
Disposables are for single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocess or resterilization may create a risk of patient infection which
could lead to injury, illness or death.
The DyeVert Plus EZ Disposable Kit should be connected to single-use contrast
source devices only. The DyeVert Plus EZ Disposable Kit does not prevent nor
protect against contamination or microbial ingress to or from a single-use
contrast source. The DyeVert Plus EZ Disposable Kit and single-use contrast
source, including any remaining contrast solution in the single-use contrast
source, should be disposed of once the procedure is completed.
Do not use if product packaging appears compromised or damaged.
Do not use catheters or contrast agents not listed in these Instructions for Use
(IFU).
Guide w/Rx Guide w/OTW
- -
- -
6F 6F
7F 7F
Refer to the Display Instructions for Use; and ensure all labeling and Instructions
for Use is followed.
•
Smart Monitor Instructions for Use and labeling, or
•
Contrast Monitoring Display Instructions for Use and labeling
Portable and mobile RF communications equipment may affect the devices. The
Display should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Display should be observed to verify
normal operation.
Use of accessories, transducers and cables other than those specified or
provided by Osprey Medical could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the Display or disposables, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
Please refer to the contrast agent Labeling for dosage recommendations,
warnings, contraindications, detail of reported adverse event types and detailed
directions for use associated with contrast administration.
For accurate Smart Syringe % contrast concentration values, ensure Smart
Syringe is initially primed with 100% contrast media and the contrast source is
100% contrast.
Refer to the Display Instructions for Use for the electromagnetic compliance
information of this system.
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. In the event contrast monitoring is not available, the procedure
may continue without contrast monitoring and the DyeVert Plus EZ Module will
continue to save contrast. 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 Plus EZ off-label may result in undesired affects such as poor
imaging, lack of contrast reduction or no contrast monitoring.
The DyeVert Plus EZ is designed to be used with non-diluted, room temperature
(non-warmed) contrast media only.
As with any device used for injecting 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 system. Do
not use tools (hemostats or other instruments).
During injections, the Smart Syringe, DyeVert Stopcock, and manifold (not
provided) should be placed where it is supported on a flat surface across the
length of the connections to prevent breakage by unintended bending when
manipulating the syringe.
Be cautious to not over-tighten on luer connections when connecting the Smart
Syringe or DyeVert Plus EZ Module to the manifold.
The Smart Syringe or DyeVert Plus EZ Module should not be immersed in
contrast or saline.
Osprey Medical recommends users follow hospital policy/procedure and
physician recommendation on the appropriate total cumulative volume of contrast
media used in a patient. The device is not intended to prevent manual injection of
contrast media.
User should ensure the Smart Syringe plunger is idle for a minimum of 1/2
second (Dwell Time) prior to switching between contrast & saline when
aspirating. If needed, contact Osprey Medical to adjust Smart Syringe plunger
dwell time to align with user preference. Inaccurate cumulative volume may be
displayed if dwell time is not reached prior to switching between aspirating
contrast & aspirating saline.
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 PATIENT ADVERSE EVENTS
Possible adverse effects include but are not limited to: air embolism, infection.
HOW SUPPLIED
Disposable, sterile system components have been sterilized with ethylene oxide
(EO).
8287-E Jan 2020