Osprey Medical CMW-XX Bedienungsanleitung

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.
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 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, 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 if the display housing is broken, contact Osprey Medical. Cosmetic
scratches do not pose a risk.
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.
™ Plus EZ Disposable Kit or
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.
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.
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.
Electromagnetic interference has been observed in testing at 385 MHz and
450 MHz causing display screen distortion or scrambling.
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 Display off-label may result in undesired affects such as 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.
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. And do not over tighten monitor clamp to IV
pole.
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
The subject device is not WiFi capable. 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. The device does not contain patient data. If these
8161-N Jan 2020