Essilor Instruments AKR 300, User Manual

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1. Important notice
This product may malfunction due to electromagnetic waves caused by portable personal telephones,
transceivers, radio-controlled toys, etc. Be sure to avoid having objects as described which affect this product,
brought near the product.
Upon request, circuit diagrams, component part lists, descriptions, calibration instructions, or other information
will be provided to assist service personnel to repair parts of the equipment that are designated by ESSILOR
INSTRUMENTS as repairable by service personnel.
2. Safety information
Accessory equipment connected to the analog and digital interfaces must be certificated according to the
respective IEC standards (e.g. IEC 62368-1 for data processing equipment and IEC 60601-1 for medical
equipment). Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the requirements of the
system standard IEC 60601-1. If in doubt, consult the technical service department or your local representative.
Do not make any changes or modifications to the equipment unless otherwise specified in the manual.
If such changes or modifications should be made, you could be required to stop operation of the equipment.
ESSILOR INSTRUMENTS is not liable for any consequences linked to this product modification.
This product is compliant with
marking.
This instrument complies with regulation 2017/745/UE.
This product is a class I medical device according to rule 13 from appendix VIII.
Date of first marking: August 2017.
The expected lifetime is 7 years.
3. Intended use
This product (AKR1KP) aims to objectively measure the refractive power of the eye by using the light that is
projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by using
the light that is projected to and reflected from the cornea. These objective data will be used to proceed to a
subjective refraction and lens or contact lens test in order to find the best prescription.
This product is for medical use which must be used under instructions of an eye care professional or a doctor.
No contraindication.
a. Symbols marked on the instrument
Symbol Description
Indicates the medical device manufacturer
Indicates the date when the medical device was
manufactured
TYPE B applied part
Alternative current
Protective earth (ground)
Indicates the need for the user to consult the
instructions for use
Mark of compliance with applicable European
directives
Medical device
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5 AKR300 - Auto Kerato Refractometer > V3 - 04-2020