Osprey Medical Display, Contrast Monitoring Instructions For Use Manual

Display, Contrast Monitoring
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) Law restricts this device to sale by or on
the order of a physician.
DEVICE DESCRIPTION
The device consists of a Contrast Monitoring Display (Model CMW-XX) to be
used with the DyeVert ™ Plus Disposable Kit, DyeVert
the DyeTect ™ Contrast Monitoring Disposable Kit during controlled infusion for
procedures requiring injection of contrast media. The Osprey Medical wireless
DyeTect Contrast Monitoring System allows for monitoring and display of
contrast volumes manually injected.
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, Pressure Transducer of the Pressure Module disposable,
Pressure Transducer and 4 Way Stopcock of the DyeVert Plus Module
disposable. Pressure Transducer of the DyeVert Plus EZ Module disposable.
ACCESSORIES
DC Power supply – Osprey Medical part # 6130 or 6145
Power Cord – Osprey Medical part # 5112-XX
INTENDED USE
The device consists of a Display to be used with the DyeVert Plus Disposable
Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring
Disposable Kit during controlled infusion for procedures requiring injection of
contrast media. The Osprey Medical wireless Contrast Monitoring System allows
for real-time monitoring and display of contrast volumes manually injected.
INDICATION FOR USE
The device consists of a display to be used with the DyeVert Plus Disposable Kit,
DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable
Kit 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.
Do not use if product packaging appears compromised.
The Display is supplied non-sterile and is reusable.
The Display is intended to be used with the DyeVert Plus Disposable Kit,
DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable
Kit only. No substitutions should be made for Osprey Medical System
components.
The Display USB port is not intended for user access. Access is to be performed
by Osprey Medical personnel. Do not use or connect components to the USB
port. If user is aware that USB port has been accessed by non-Osprey Medical
personnel, do not use display and contact Osprey Medical.
The Display Osprey Settings defines system parameters which are not inputted
by users; nor do users have access. Access is intended only by Osprey Medical
Inc. personnel.
Prior to using the Display, please ensure all labeling of compatible devices being
used is followed. This may include, but is not limited to, considerations regarding
type of procedure, patient population or contrast agents.
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.
To avoid the risk of electric shock, the Display must only be connected to a
supply mains with protective earth.
No modifications of the Display are allowed.
™ Plus EZ Disposable Kit or
PRECAUTIONS
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.
The DyeVert Plus and Plus EZ Modules are designed to be used with non-
diluted, room temperature (non-warmed) contrast media only.
For accurate Smart Syringe % contrast concentration values, ensure system is
initially primed with 100% contrast media and the contrast source is 100%
contrast.
Be cautious to not over-tighten luer connections when connecting Osprey
Medical disposable components to a manifold.
The Osprey Medical disposable components should not be immersed in contrast
or saline.
The Display should not be immersed for cleaning.
The Display should only be connected to the power supply with the Osprey
Medical supplied power cord. Do not modify or change the supplied power cord.
Only a grounded power cord should be used.
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 Display is not intended to prevent manual injection
of contrast media.
User should ensure the Smart Syringe plunger is idle for 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 graphical range indicator displayed when a threshold is entered is not
representative of a recommended contrast dosage.
If using a threshold, the physician entered threshold volume should take into
consideration renal function through estimated GFR or exogenous measured
GFR in cases where an estimated GFR may be inaccurate (i.e. extreme body
size, ethnicity, race, sex, age, muscle mass, unusual dietary intake, pregnant
women, etc.).
POTENTIAL PATIENT ADVERSE EVENTS
Please refer to the contrast agent being used Instructions for Use and Labeling
for a detailed list of reported adverse events.
CYBERSECURITY
If in the case of a security failure to the system, the following may occur: loss of
monitoring capability and/or incorrect reporting of contrast injected. If these
events occur, the user may continue to use the disposables for contrast injection
without modifications. A security failure will not cause an inadvertent or
independent contrast injection. If a security failure occurs, please contact Osprey
Medical.
If the product and/or packaging appears to be tampered with, please do not use
and contact Osprey Medical.
HOW SUPPLIED
The Display is provided non-sterile.
STORAGE
Storage conditions for the Display:
Temp = -20°C to 60°C
Humidity = 10% to 85%, noncondensing
Pressure = 50 kPa to 106 kPa
MAINTENANCE and REPAIR
Maintenance is not required. Contact Osprey Medical if Display repairs are
required.
DISPOSAL
The Display should not be disposed of by the user. Contact Osprey Medical to
arrange for shipment of the Display for disposal.
CLEANING DISPLAY
Non-disposable components (display, power cord) should be cleaned in
accordance with hospital policy and procedure with Super Sani-Cloth (or
equivalent) or a cloth dampened with 70/30 isopropyl alcohol. Avoid use of
solvents or abrasive cleaners which may damage the plastic portion of these
components or the touch screen.
OPERATING ENVIRONMENT & 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 or with magnetic resonance imaging (MRI) where the intensity of
electromagnetic disturbances is high.
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