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INSTRUCTIONS FOR USE
ENVIRONMENTAL PARAMETERS
OPERATING CONDITIONS
Device has been tested and proven to operate within the following conditions:
104 F/40 C
50 F/10 C
Temperature
SHIPPING AND STORAGE CONDITIONS
Device has been tested and proven to operate after repeated exposure to the following conditions:
120 F/49 C
0 F/-18 C
Temperature
The materials and components used in the construction of this device were selected to ensure that the device could be shipped by
any standard commercial method without special handling conditions.
DEFINITIONS
•
NOTE: Used to point out the easiest means of carrying out techniques.
•
CAUTION: Used to point out special procedures or precautions that must be followed to avoid damaging the system
instrumentation.
•
WARNING: Used to indicate that the safety of the patient and hospital personnel could be involved.
GENERAL WARNINGS AND CAUTIONS
•
WARNING: Failure to lock the Blade Assembly in place may cause the Blade Assembly to separate from the Handpiece, which
may injure the patient or damage the instrument.
•
WARNING: Do not over-tighten screw-lock on blade; this may result in blade not retracting, which may injure the patient.
•
WARNING: The blade is sharp; handle with care. Blade assembly should be properly disposed. DO NOT re-sterilize the Blade
Assembly – it is designed for single use only.
•
WARNING: The MicroAire system uses a dry procedure. No fluid or gas should be introduced into the carpal tunnel during this
procedure. Fogging may occur as a result and visualization may be compromised.
•
CAUTION: If the O-ring is not compressed, it does not form a moisture-proof seal and fogging may occur at the
camera/endoscope interface. (Video Endoscope Only)
•
CAUTION: Do not use clamps or forceps when handling the endoscope.
•
CAUTION: Do not handle the endoscope at the distal end. Grasp the camera mount or eyepiece end only.
•
CAUTION: Do not place other items on top of the endoscope.
•
CAUTION: Do not ultrasonically clean the endoscope or use solvents other than isopropyl alcohol.
•
CAUTION: Other sterilization systems that are not listed have not been tested and no recommendations can be made.
•
CAUTION: Do not steam autoclave the Video Endoscope.
•
CAUTION: Soaking the Video Endoscope for longer than two hours may damage the Endoscope.
•
CAUTION: Federal Law (USA) restricts this product sale by or on the order of a physician or hospital.
PRECAUTIONS
•
Universal precautions for handling contaminated materials should be observed at all times.
•
DO NOT lubricate or oil the handpieces.
•
DO NOT immerse the handpiece in any fluid.
•
DO NOT use high pH cleaning solutions unless they are approved for use with anodized aluminum and surgical instruments.
•
DO NOT use cleaning agents with chlorine or chloride as the active ingredient is corrosive to stainless steel.
™
SMARTRELEASE
INSTRUCTIONS FOR USE
91%
0
Humidity
91%
0
Humidity
IM-SMARTRELEASE REV E
106
86
Atmospheric
106
86
Atmospheric
3 |
P a g e
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