FHC microTargeting 66-DA-ME, Инструкция по применению

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L011-80 Rev. C0 2020-11-05 Page 5 of 17
Operating Environment:
The controller and accessories are designed to be used in the normal operating room environment and require no special
handling or care exceptional to other electronic devices used in that environment. The controller and hand held remote control
should be positioned within 3 meters of but outside the sterile field, the motor unit is sleeved inside a sterile drape sleeve and
mounted on the drive within the sterile field.
Temperature Range: +5°C to +40°C
Relative Humidity Range: 10% to 95% (non-condensing)
Atmospheric Pressure Range: 500 hPa to 1060 hPa
Altitude: ≤ 2000 m above sea level
Storage and Transport Conditions
The microTargeting™ Controller Power Assist System should be stored and transported within the carrying case provided when
not in use.
Warnings and Cautions:
WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains power outlet with
Protective Earth (3 pronged socket), never use a damaged power cord or power strip.
CAUTION: High voltage - there are no user serviceable parts internal to the controller housing, do not attempt to disassemble
the controller or any of its accessories.
WARNING: No unauthorized modification of this equipment is allowed.
WARNING: Do not block the vents on the bottom or back of the controller as this could cause it to overheat. Do not remove
the 4 rubber feet as this will cause the vents on the bottom of the controller to become blocked.
WARNING: Carefully route all system cabling away from high traffic areas.
WARNING: Do not manually rotate the drive knobs when the motor is attached as this could potentially damage the motor unit.
Note: To ensure optimal performance and minimize motor noise, the controller system should be serviced annually to tune the
controller’s drive circuit and speed settings to compensate for normal motor wear.
WARNING: Do not use the controller in the presence of flammable gas mixtures.
WARNING: Do not attempt to sterilize the motor unit or the hand held remote control.
WARNING: Expected target depth can change based on the stereotaxy and electrodes used. Ensure the target depth is set
correctly when running the controller in distance to target mode.
WARNING: Always zero the controller prior to inserting electrodes.
WARNING: Periodically (every 5mm is recommended) verify that the depth reported by the controller matches that shown on
the drive scale.
WARNING: If power to the controller is temporarily interrupted, it will need to be re-zeroed prior to resuming its use.
CAUTION: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the Declaration of Electromagnetic Emissions section of this document.
CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING: The controller should not be used adjacent to or stacked with other equipment. Where such an arrangement is
necessary, the controller should be observed to verify normal operation prior to use.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rx only