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CAN Infrascanner Model 2000 Operator Manual
INFRASCAN, INC. VERSION 1 Page 12 of 41
2.1.2 General Warnings
SYMBOL
GENERAL WARNING
THE INFRASCANNER CONTAINS A NEAR INFRARED LASER
(CLASS 1). DO NOT ALLOW THE LASER LIGHT TO ENTER THE
EYES.
THE INFRASCANNER IS NOT SUITABLE FOR USE IN THE
PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR
OR WITH OXYGEN OR NITROUS OXIDE. A FIRE MAY RESULT.
KEEP THE INFRASCANNER AWAY FROM FLAMMABLE SOURCES.
THE INFRASCANNER IS A SCREENING DEVICE INTENDED AS AN
ADJUNCT TO THE STANDARD CLINICAL ASSESSMENT OF ADULT
PATIENTS WITH SUSPECTED TRAUMATIC INTRACRANIAL
HEMATOMA. A “NEGATIVE” INFRASCANNER RESULT SHOULD BE
INTERPRETED WITH CAUTION SINCE SUCH A RESULT DOES NOT
ADEQUATELY EXCLUDE THE PRESENCE OF SERIOUS
UNDERLYING INTRACRANIAL HEMATOMA.
IN THE CLINICAL STUDY OF THE DEVICE, PATIENTS WERE TO BE
SCANNED WITH THE INFRASCANNER WITHIN 30 MINUTES
BEFORE OR AFTER A CT SCAN. SINCE A TRAUMATIC HEMATOMA
MAY EVOLVE RAPIDLY THE INFRASCANNER RESULT IS NOT
PREDICTIVE OF THE ABSENCE OF A HEMATOMA WHEN LONGER
THAN 30 MINUTES HAVE ELAPSED SINCE THE TEST WAS
COMPLETED.
COMPLETE THE TRAINING AND READ THE ENTIRE OPERATOR
MANUAL BEFORE ATTEMPTING TO OPERATE THE
INFRASCANNER.
ONLY CONNECT THE CRADLE POWER ADAPTER TO THE
CRADLE, OTHERWISE HAZARDS MAY EXIST.
THE INFRASCANNER SHOULD NOT BE MODIFIED IN ANY WAY OR
BY ANY USER. UNAUTHORIZED MODIFICATIONS TO THE
INFRASCANNER MAY CAUSE IT TO MALFUNCTION OR FAIL IN
USE.
USE CAUTION IN EXERCISING PRESSURE ON THE HEAD WHEN
USING INFRASCANNER, SINCE EXCESSIVE PRESSURE MIGHT
EXACERBATE AN UNDERLYING SKULL INJURY.
THE SAFETY/EFFICACY OF THE INFRASCANNER IN SUBJECTS
<18 YEARS OLD HAS NOT BEEN EVALUATED.
Summary of Contents for 2000
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