LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08
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Indications for Use
The OptoMonitor 3 is indicated for use to measure pressure in blood vessels including both coronary
and peripheral vessels, during diagnostic angiography and/or any interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for
the diagnosis and treatment of blood vessel disease.
Intended user
The OptoMonitor 3 is intended to be used or supervised by cardiologists.
Intended environment
The OptoMonitor 3 is intended to be used in catheterization laboratories.
Contraindications
The system has no patient alarm functions. Do not use for cardiac monitoring. The system is
contraindicated for use in cerebral vasculature.
Safety
Warnings
•
Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating condition.
•
The power supply and cord used with the OptoMonitor 3 must be supplied by OpSens or
personnel authorized by OpSens to ensure compliance with local standards.
•
To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics
mixture with oxygen or nitrous oxide, vapors or liquids.
•
No modification of this equipment is allowed. Do not open the OptoMonitor 3 housings. All
servicing and future upgrades must be carried out by the personnel trained and authorized by
OpSens only.
•
Do not use OptoMonitor 3 if it has been dropped or in another way exposed to mechanical or
electrical damage or if liquids have penetrated the housing. The user or patient may be exposed
to electrical shock or faulty readings may appear. In the event of system damage, turn the
system off; unplug the system from the power outlet and contact a qualified field service person
and/or OpSens authorized service person or OpSens.
•
In the event of any anomalies observed on system, accessories or labels, please contact a
qualified field service person and/or OpSens authorized service person or OpSens.
•
The OptoMonitor 3 has no patient alarm functions. The audio indicator is for system status
indications only.
•
To avoid inadvertent disconnection, route all cables and secure excess cabling in a way to
prevent a stumbling and entanglement hazard.
•
Power supply is specified as a part of
ME EQUIPMENT
or combination is specified as a
ME SYSTEM
.
Connection of equipment that do not follow relevant IEC standard for medical equipment (e.g.
IEC 60601) may lead to patient injury or death.
•
Always keep portable RF communications equipment (including peripherals such as antenna
cables and external antennas) at least 30 cm (12 inches) from any part of the OptoMonitor 3,
including cables specified by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
•
The OptoMonitor 3 system is designed to be used nearby all devices that could potentially be
installed nearby to the location of its INTENDED use.
•
OptoMonitor 3 cannot be used in homecare environment. This device is intended to be used in
properly equipped healthcare facilities, such as a Cathlab.