Osprey Medical Smart Monitor Instrucciones De Uso

Smart Monitor
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 Smart Monitor, Model Number: "SMART" (Re-order number
SMART-XX) to be used with the DyeVert
Kit or the DyeTect ™ Contrast Monitoring Disposable Kit during controlled infusion for procedures
requiring injection of contrast. The Smart Monitor allows for monitoring and display of contrast
volumes manually injected.
CMS CLASSIFICATION
• Type of protection against electric shock: Class II or internally powered.
• 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 DyeTect Pressure Module, Pressure Transducer &
T-Connector of the DyeVert Plus EZ Module disposable, Pressure Transducer and 4 Way
Stopcock of the DyeVert Plus Module disposable.
ACCESORIES
DC Power Supply Assembly - Osprey Medical part # 6173-XX
INTENDED USE
The device consists of a Smart Monitor 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 Smart Monitor allows for real-
time monitoring and display of contrast volumes manually injected.
INDICATION FOR USE
The device consists of a Smart Monitor 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
Do not use with power injectors.
WARNINGS
Disposables are for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
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 Smart Monitor is supplied non-sterile and is reusable.
The Smart Monitor 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 Smart Monitor Lightening™ Dock port is not intended for user access. Access is to be
performed by Osprey Medical personnel, and Smart Monitor charging connection.
The Smart Monitor Osprey Settings defines system parameters which are not inputted by users;
and users do not have access. Access is intended only by
Medical representative.
Prior to using the Smart Monitor, please ensure all labeling of compatible devices being used
(such as the DyeVert Plus EZ Disposable Kit) 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.
No modification of the Smart Monitor is allowed.
The Smart Monitor will only run the Osprey DyeVert app and non-Osprey apps approved for
download by Osprey Medical. The Smart Monitor will only work with Osprey Medical disposable
devices. The location of the Smart Monitor is tracked electronically.
PRECAUTIONS
As with any device used for injecting contrast 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 Disposable Kit and DyeVert Plus EZ Disposable Kit is designed to be used
with non-diluted, room temperature (non-warmed) contrast only.
For accurate Smart Syringe % contrast concentration values, ensure system is initially primed
with 100% contrast and the contrast source is 100% contrast.
™ ™
Plus Disposable Kit, DyeVert Plus EZ Disposable
Be cautious to not over-tighten on 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 Smart Monitor should not be immersed for cleaning.
The Smart Monitor should only be connected to the power supply with the Osprey Medical
supplied power cord. Do not modify or change the supplied power cord.
Osprey Medical recommends users follow hospital policy/procedure and physician
recommendation on the appropriate total cumulative volume of contrast used in a patient. The
Smart Monitor is not intended to prevent manual injection of contrast. The graphical range
indicator displayed when a threshold is entered is not representative of a recommended contrast
dosage.
User should ensure the Smart Monitor dwell time (1/2 second) 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 being reached.
When 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.).
Although very unlikely to occur it is recommended to not touch the Smart Monitor or DC power
supply (USB power adapter) while in direct contact with the patient to avoid the possibility of
leakage current being transmitted to the patient.
POTENTIAL PATIENT ADVERSE EVENTS
Refer to the Instructions for Use and Labeling for the contrast agent being used for a detailed
list of reported adverse events.
CYBERSECURITY
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 Smart Monitor is provided non-sterile.
STORAGE
Storage conditions for the Smart Monitor:
Temp = -20°C to 45°C
Humidity = 5% to 95%, noncondensing
MAINTENANCE and REPAIR
Maintenance is not required. Contact Osprey Medical if Smart Monitor repairs are required.
DISPOSAL
The Smart Monitor should not be disposed of by the user. Contact Osprey Medical to arrange
for shipment of the Smart Monitor for disposal.
CLEANING SMART MONITOR
To clean the Smart Monitor, unplug all cables and turn off Smart Monitor (press and hold the
Sleep/Wake button, and then slide the onscreen slider). Use a soft, slightly damp, lint-free cloth.
Avoid getting moisture in openings. Don't use window cleaners, household cleaners, aerosol
sprays, solvents, alcohol, ammonia, or abrasives to clean Smart Monitor. The Smart Monitor has
an oleophobic coating on the screen. The ability of this coating to repel oil will diminish over time
with normal usage, and rubbing the screen with an abrasive material will further diminish its
effect and may scratch your screen.
Alternative option to clean the Smart Monitor, power supply or power cord:
with hospital policy and procedure with Super Sani-Cloth (or equivalent). Do not use solvents or
abrasive cleaners.
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 5% to 85%, noncondensing
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.
MASS of DEVICES
Smart Monitor
DyeVert Plus Module
Dyevert Plus EZ Module w/Contrast Collection Bag
Smart Syringe
(DyeTect) Pressure Module
clean in accordance
831g
97g
135g
44g
38g
8280-B