Osprey Medical R-RRL Instructions For Use Manual

Smart Syringe
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) Law restricts this device to sale by or on
the order of a physician.
DEVICE DESCRIPTION
The Smart Syringe is a component to the DyeVert
System, DyeVert Plus™ EZ Contrast Reduction System and DyeTect™ Contrast
Monitoring System. The Smart Syringe is not intended to be used independently.
The Smart Syringe is a control syringe with wireless communication capability to
the Osprey Medical Display.
MODEL NUMBER SELECTION
Model Number Syringe Description
R-RRL Locking Luer, Ring Plunger – Ring Grip
R-PRL Locking Luer, Palm Plunger – Ring Grip
R-PWL Locking Luer, Palm Plunger – Wing Grip
R-RRS Swivel Luer, Ring Plunger – Ring Grip
R-PRS Swivel Luer, Palm Plunger – Ring Grip
R-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
INTENDED USE
The Smart Syringe is intended to be used for the controlled infusion of
radiopaque contrast media for angiographic procedures with the DyeVert Plus
and DyeVert Plus EZ Contrast Reduction Systems or the DyeTect Contrast
.
Monitoring System
INDICATION FOR USE
The Smart Syringe is to be used with the DyeVert Plus and DyeVert Plus EZ
Contrast Reduction Systems or the DyeTect Contrast Monitoring System. The
DyeVert Plus and DyeVert Plus EZ Contrast Reduction Systems are to be used
for contrast volume reduction and for the monitoring of radiopaque contrast media
during angiographic or CT procedures with the following agents: Iodixanol 270 or
320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL. The DyeTect
Contrast Monitoring System is to be used during angiographic or CT procedures
requiring controlled infusion of radiopaque contrast media.
CONTRAINDICATIONS
Not for use with power injectors.
WARNINGS
Refer to the DyeVert Plus, DyeVert Plus EZ Contrast Reduction Systems or the
DyeTect Contrast Monitoring System Instructions for Use for additional
information, prior to use.
If the Smart Syringe is not paired with the Contrast Monitoring Display in
conjunction with a DyeVert Plus Module, DyeVert Plus EZ Module or DyeTect
Pressure Module, accurate accounting of contrast use will not occur.
The Smart Syringe is 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.
Do not use if product packaging appears compromised or damaged.
Please refer to the contrast agent Instructions for Use and 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.
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
™
Plus Contrast Reduction
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
Refer to the Smart Monitor or Contrast Monitoring Display Instructions for Use for
the electromagnetic compliance information of this system.
In the event contrast monitoring is not available, the procedure may continue
without contrast monitoring.
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 Smart Syringe off-label may result in undesired affects such as poor
imaging, lack of contrast reduction or 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, prior to injection, to avoid air
embolization.
Use only light tapping if necessary to remove air while priming the Smart Syringe.
Do not use tools (hemostats or other instruments).
Be cautious to not over-tighten on luer connection when connecting the Smart
Syringe to a manifold.
The Smart Syringe 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 Smart Syringe is not intended to prevent manual
injection of contrast media.
User should ensure the Display dwell time is reached prior to Smart Syringe
aspiration and if needed, contact Osprey Medical to adjust dwell time to align
with user preference. Inaccurate cumulative volume may be displayed if
aspiration occurs prior to dwell time is reached.
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 normal storage, the temperature should be between +10°C (50°F) and +25°C
(77°F) and never exceed +30°C (86°F).
MAINTENANCE and REPAIR
Maintenance is not required.
DISPOSAL
Discard Smart Syringe according to hospital procedures.
The Smart Syringe has 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:
Temperature: 10°C to 27°C (50°F to 80°F)
Relative humidity 0% to 85%, noncondensing
Pressure = 60 kPa to 106 kPa
The system is not intended be used near active high frequency surgical
equipment where the intensity of electromagnetic disturbances is high.
MRI SAFTEY INFORMATION
The Smart Syringe is MR UNSAFE. Keep it outside the MRI Scanner room.
MASS of DEVICES
Smart Syringe
PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable with Cath lab procedures,
techniques and contrast media usage.
44g
8259-F Jan 2020