Osprey Medical DyeTect Instrucciones De Uso

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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
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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:
8176-M Jan 2020