Osprey Medical DyeVert Plus HV-EZ EU Serie Instrucciones De Uso

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) Monitor (provided separately) and
2) DyeVert Plus EZ Disposable Kit.
The Monitor 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 Monitor 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)
LV-EZ-XXX-EU 4.7 to 8.1 cps (mPa*s)
Note: "-XXX" identifier is denoted as available syringe
configurations
CMS CLASSIFICATION
• The DyeVert Plus EZ Disposable Kit is Internally Powered
• The Monitor is class II or Internally Powered
• The Contrast Monitoring Display is Class 1 type of protection against electric
shock.
• 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, the DyeVert Plus EZ Module disposable, 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 Osprey Medical Contrast Monitoring Display or Smart Monitor
Instructions for Use for additional information specific to the Monitor.
Ensure all instructions provided on the labels and Instructions for Use are
followed.
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.
PRECAUTIONS
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).
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 Smart Syringe, DyeVert Plus EZ Module with Contrast Collection Bag
and single-use contrast source according to hospital procedures. The contrast
in the Contrast Collection Bag should not be reused.
The Smart Syringe and DyeVert Plus EZ Module have been designed to comply
with battery waste regulations. At the end of device use, the alkaline batteries
are inside 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
under the following conditions:
Temperature: 10°C to 27°C (50°F to 80°F)
Relative humidity 0% to 85%, noncondensing
The system is not intended be used near active high frequency surgical
equipment or with magnetic resonance imaging (MRI) where the intensity of
electromagnetic disturbances is high.
MASS of DEVICES
Smart Monitor with Clamp
Contrast Monitoring Display with Clamp
DyeVert Plus EZ Module with Waste Bag
Smart Syringe
PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable with Cath lab procedures,
techniques and contrast media usage.
831g
1483g
135g
44g
8287-D