Osprey Medical DyeVert Power XT Manuals

8285-E 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 Guide Guide w/Rx 4F - - 5F - - 6F 6F 6F - 7F 7F 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. 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-H Jan 2020 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 Guide Guide w/Rx 4F - - 5F - - 6F 6F 6F - 7F 7F 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. 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)