8280-G Jan. 2020
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
™
Plus Disposable Kit, DyeVert
™
Plus EZ Disposable 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.
The contrast monitoring system will measure and display the cumulative injection volume
delivered to the patient with an accuracy of +/-10%.
Monitoring of contrast administration should not be used for diagnostic or therapeutic decisions.
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. If the product and/or packaging appears
to be tampered with, please do not use and contact Osprey Medical.
Do not use Smart Monitor if the display housing is broken, contact Osprey Medical. Cosmetic
scratches do not pose a risk.
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.
Portable and mobile RF communications equipment may affect the devices. The Smart Monitor
should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the Smart Monitor should be observed to verify normal operation.
Use of accessories, transducers and cables other than those specified or provided by Osprey
Medical, Inc. 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 Smart
Monitor or disposables, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this equipment could result.
Electrostatic Discharge interference has been observed at the home button of the Smart Monitor
causing screen flicker.
If performance of the system is lost or degraded due to electromagnetic interference, the
procedure may continue without contrast monitoring.
PRECAUTIONS
In the event the device malfunctions or changes in performance that is not expected,
discontinue use of disposables 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 Smart Monitor off-label may result in undesired affects such as no contrast
monitoring.
Do not perform an iPadOS or software update immediately prior to a case as the update may
require an extended time to update depending on WiFi connection and size of update.
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.
Be cautious to not over-tighten on luer connections when connecting Osprey Medical disposable
components to a manifold. And do not over tighten monitor clamp to IV pole.
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
Refer to the Osprey Medical Wireless Security and Measures
Manual, p/n 8299, for detailed information regarding Quality of
Service and Wireless/Bluetooth security.
Osprey Medical utilizes Mobile Device Management (MDM) on the Smart Monitor. The MDM
setup allows for configuring the iPadOS device’s WiFi settings, locking the wallpaper, hiding
iPadOS apps in the launcher except for Settings and desired apps, and preventing iPadOS
notifications. Other MDM capabilities include: locking, locating and wiping iPadOS devices,
locking an app into “Kiosk” mode so that the user cannot leave the Osprey application during a
case, and preventing iPads from being accessed via a lightning cable. MDM is used to lock down
various iPadOS features and settings. For example, the Osprey Smart Monitor is specially
configured to only allow certain apps to be available to the user and sets restrictions on what the
user can change in settings. The user is not required to take additional steps After applying the
MDM setup configuration, the Smart Monitor users only have access to the following features:
DyeVert Plus app, eGFR Calculator app, Settings app (with restrictions via MDM).
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.
Wireless Quality of Service
The smart monitor utilizes Wi-Fi of an iPad mini to communicate with mobile device management
(MDM) and amazon web services (AWS). These communications are not critical to the
procedure as this device is not required to be connected to Wi-Fi before, during or after a case.
The Smart Monitor is for real-time monitoring and display of contrast volumes manually injected
which does not require a Wi-Fi connection. The smart monitor has memory to store all data in
onboard non-volatile memory. Thus, if a period where the smart monitor is unable to
communicate with AWS occurs, the device will store this data and communicate it to AWS as
soon as a connection can be established. With respect to the loss of data due to limited quality
of service, the system provides for confirmation logs that all data have been communicated from
the smart monitor to AWS.
HOW SUPPLIED
The Smart Monitor is provided non-sterile.
EU Declaration of Conformities are available upon request.
STORAGE
Storage conditions for the Smart Monitor:
Temp = -20°C (-4°F) to 45°C (113°F)
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.
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