
4 16010-101 Rev. C
Warnings & Cautions
Reichert, Inc. (Reichert) is not responsible for the safety and reliability of this instrument when:
• Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons
• Instrument is not used in accordance with this User’s Guide
WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH.
WARNING: UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT THIS DEVICE BE
PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN. ONLY
OPERATORS TRAINED IN THE USE OF OPHTHALMIC INSTRUMENTS THAT CONTACT THE EYE SHOULD USE
THIS DEVICE. REICHERT, INC. CANNOT BE HELD RESPONSIBLE FOR ANY DAMAGE OR INJURY THAT
RESULTS FROM A FAILURE TO FOLLOW DIRECTIONS IN THE USER’S MANUAL. PLEASE ENSURE THAT
YOU ARE ENTIRELY FAMILIAR WITH THE CORRECT PROCEDURES FOR OPERATING THE INSTRUMENT
BEFORE USE!
WARNING: IN ORDER TO PREVENT PATIENT-TO-PATIENT TRANSFER OF INFECTION, AFTER EACH USE DISINFECT THE
PROBE FOLLOWING ACCEPTED LOCAL CLINICAL PROCEDURES REGARDING THE USE OF
DISINFECTANTS. ANY CLINICALLY APPROVED CHEMICAL DISINFECTANT CAN BE USED. AFTER EACH
PATIENT, WE RECOMMEND WIPING THE PROBE WITH A COTTON SWAB SOAKED IN 70% ISOPROPYL
ALCOHOL, AND THEN IMMERSING THE PROBE TIP FOR 10 MINUTES IN 70% ISOPROPYL ALCOHOL OR AN
EQUIVALENT LOCALLY APPROVED DISINFECTANT. THE PROBE AND CABLE MAY BE IMMERSED IN
LIQUID, BUT THE CONNECTOR AND MAIN UNIT CANNOT BE IMMERSED IN ANY LIQUID. DO NOT STERILIZE
THE PROBE USING ETO, AUTOCLAVING, OR IRRADIATION. AFTER CLEANING, RINSE THE END OF THE
PROBE THOROUGHLY WITH STERILE DISTILLED WATER. DRY THE PROBE WITH A LINT FREE CLOTH OR
TISSUE. ALWAYS STORE THE PROBE WHEN NOT BEING USED IN THE PROVIDED HOLDER TO PROTECT IT.
DO NOT USE THE PROBE AS A STYLUS. DO NOT ATTEMPT TO USE THE IOPAC IF THERE IS ANY
INDICATION THE PROBE TIP, BODY, OR CABLE HAS BEEN DAMAGED AND/OR THEIR PHYSICAL INTEGRITY
HAS BEEN COMPROMISED. IF THE PROBE TIP HAS MADE CONTACT WITH ANYTHING BETWEEN
APPLANATIONS, REPEAT DISINFECTING PROCEDURE.
WARNING: MEASUREMENTS SHOULD NOT BE ATTEMPTED WHEN OCULAR INTEGRITY IS QUESTIONABLE. THE
HANDHELD TRANSDUCER MUST TOUCH THE EYE DURING OPERATION. CONSEQUENTLY, THE OPERATOR
NEEDS TO EXHIBIT CARE IN MANIPULATING THE TRANSDUCER. FORCE SHOULD NOT BE EXERTED
AGAINST THE EYE – THE TRANSDUCER TIP ONLY NEEDS TO LIGHTLY TOUCH THE CORNEA.
WARNING: TO ENSURE PATIENT ISOLATION FROM HIGH ELECTRICAL POTENTIAL, DO NOT USE THE IOPAC ON A
PATIENT WHEN THE INSTRUMENT IS CHARGING. IOPAC CHARGING MUST ONLY TAKE PLACE AT A
DISTANCE OF AT LEAST 1.5 M FROM THE PATIENT.
WARNING: DO NOT USE ANY TRANSDUCER PROBE ON THE IOPAC OTHER THAN THE ONES SUPPLIED EXPRESSLY
FOR THIS PURPOSE. OTHER TRANSDUCERS MAY NOT GENERATE ACCEPTABLY LOW ULTRASOUND
ENERGY LEVELS.
WARNING: CARE SHOULD BE EXERCISED WHEN HANDLING THE TRANSDUCER, TO AVOID BREAKING THE TIP AT THE
ELBOW (ANGLED TRANSDUCERS ONLY). EXTREME FORCE SHOULD NEVER BE APPLIED WHEN
REMOVING OR STORING THE TRANSDUCER IN ITS HOLDING CLIP.
CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT.
CAUTION: DO NOT INSTALL ANY ADDITIONAL SOFTWARE. ALTHOUGH THIS PRODUCT USES THE PALM OPERATING
SYSTEM, IT IS A DEDICATED PACHYMETER AND MUST NOT BE USED FOR ANY OTHER PURPOSE. THE
USE OF THIS DEVICE WITH ANY SOFTWARE OTHER THAN THAT SUPPLIED WITH THE PACHYMETER HAS
NOT BEEN VALIDATED. THE MANUFACTURER OR DISTRIBUTOR CANNOT BE HELD RESPONSIBLE FOR
ANY FAILURES RESULTING FROM THE USE OF UNAUTHORIZED SOFTWARE.
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