Osprey Medical DyeTect RRL Manuals

8176-M Jan 2020 DyeTect™Contrast Monitoring Disposable Kit INSTRUCTIONS FOR USE CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION The DyeTect™ Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Display during controlled infusion for procedures requiring injection of contrast media. The DyeTect Contrast Monitoring System allows for monitoring and display of contrast volumes manually injected The Pressure Module has been designed for use with 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”. MODEL NUMBER SELECTION - Disposables Model Number Syringe Description RRL Locking Luer, Ring Plunger – Ring Grip PRL Locking Luer, Palm Plunger – Ring Grip PWL Locking Luer, Palm Plunger – Wing Grip RRS Swivel Luer, Ring Plunger – Ring Grip PRS Swivel Luer, Palm Plunger – Ring Grip PWS Swivel Luer, Palm Plunger – Wing Grip CMS CLASSIFICATION • Type of protection against electric shock: Class 1. • 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 and Pressure Transducer of the DyeTect Pressure Module. All parts are single use, disposables. INTENDED USE The Contrast Monitoring Disposable Kit consists of a Smart Syringe and a Pressure Module to be used with the Display during controlled infusion for procedures requiring injection of contrast media. The Osprey Medical DyeTect Contrast Monitoring System allows for real-time monitoring and display of contrast volumes manually injected. INDICATION FOR USE The DyeTect™ Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Display during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. 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 DyeTect Contrast Monitoring Disposable Kit should be connected to single- use contrast source devices only. The Pressure Module does not prevent nor protect against contamination or microbial ingress to or from a single-use contrast source. The DyeTect Contrast Monitoring Disposable Kit and single-use contrast source, including any remaining contrast solution in the single-use contrast source, should be disposed of following the procedure. Do not use if product packaging appears compromised. Refer to the specific Display Instructions for Use and ensure all labeling and Instructions for Use are followed: • Smart Monitor Instructions for Use and labeling, or • Contrast Monitoring Display Instructions for Use and labeling 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. Changes or modifications to the Monitor, Smart Syringe or Pressure Module not expressly approved by Osprey Medical could void the user’s authority to operate the equipment. Portable and mobile RF communications equipment may affect the devices. The Monitor 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 Monitor or disposables, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Refer to the Smart Monitor or Contrast Monitoring 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. 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 DyeTect off-label may result in undesired affects such no contrast monitoring. As with any device used for injecting contrast media into a patient, care should be taken to assure 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). Be cautious to not over-tighten on luer connections when connecting the Smart Syringe and/or Pressure Module to a manifold. The Smart Syringe or Pressure 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. 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). EU Declaration of Conformities are available upon request. STORAGE For optimal battery life, store the DyeTect Disposable Kit between 10°C and 25°C (50°F and 77°F) and do not exceed 30°C (86°F). MAINTENANCE and REPAIR Maintenance is not required. DISPOSAL Discard Smart Syringe, Pressure Module and single-use contrast source according to hospital procedures. The Smart Syringe and Pressure 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.Follow local governing ordinances regarding disposal. Do not incinerate as the enclosed batteries may explode at excessive temperatures. OPERATING CONDITIONS The system is intended to be used in a standard hospital Cath lab environment under the following conditions: