
15
Introduction to the Oscar Express ABP Monitor: Oscar 2
Safety and Effectiveness
The following safety and effectiveness issues should be considered before using the Oscar 2 unit
as part of the Oscar Express system:
•
This device is defibrillator protected
.
Note
: No precautions specific to the Oscar 2 are required during defibrillation, and defibrillation
discharge has no effect on the Oscar 2.
•
The monitor is intended for use following consultation and instruction by a physician.
•
The reliability of the device is dependent upon conformance with the operation and service
instructions, as detailed in this manual.
•
This device has been designed for use on patients with normal sinus rhythms.
•
The interpretation of blood pressure measurements should only be made by a physician. The
accuracy of any blood pressure recording may be affected by the position of the subject, his or
her physical condition, and use outside the operating instructions detailed in this manual.
•
Safety and effectiveness on pregnant women and neonates have not been established.
SunTech Medical Instruments, Inc. is responsible for the safety, reliability, and performance of its
equipment under the following conditions:
•
Assembly operations, extensions, re-adjustments, modifications, and repairs are carried out by
SunTech authorized personnel.
•
The electrical installation of the relevant room complies with all Local, State and Federal
building and electrical codes.
•
All equipment is used in accordance with instructions for its use.
Contact SunTech Medical Instruments for information before connecting any devices not
mentioned in this Oscar Express Central Terminal User's Guide.
To ensure patient safety, use only parts and accessories manufactured or recommended by
SunTech Medical Instruments.
Warnings and Contraindications
DO NOT
—use in the presence of the flammable anesthetics; this could cause an explosion.
DO NOT
—immerse the monitor in any fluid, place fluids on top, or attempt to clean the unit with
any liquid detergents or cleaning agents. This may cause an electrical hazard. If accidental wetting
occurs, please return to SunTech (See
Oscar Express and AccuWin Express Technical
Assistance
).
DO NOT
—remove unit covers. The monitor does not contain any user-serviceable components.
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