Autorefractor, portable

GENERAL DESCRIPTION
Portable autorefractor for objective measurement of refractive error of the eye by measuring how light is changed when it enters the patient's eye.

INTENDED USE
For use by trained eye care professionals to measure the refractive power of the eye and determine refractive error by assessing light reflexes from the retina.

TECHNICAL SPECIFICATIONS
Automated refraction measurement devices.
Handheld, portable design with integrated forehead support.
Designed for monocular measurements.
Measurement principle: Shack-Hartmann wavefront sensing.
Measurement range: sphere -10D to +10D; Cylinder -5D to +5D; axis 1-180°.
Minimum pupil size: 2.5mm
Class 1 laser product (according to IEC 60825-1: 2014).
Rechargeable battery providing up to 5 hours continuous operation.
Data export via printing, Bluetooth or USB.

SUPPLIED WITH
Instructions for use and maintenance in English, French and Spanish.
1 x charging docket station
1 x portable thermal printer
Lens wipes

ESTIMATED LIFE SPAN
3 years

WARRANTY
2 years

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 40C/ 10 to 95% relative humidity
Storage conditions: -10 to 55C/ 10 to 95% relative humidity

WEIGHT AND VOLUME
Weight: 1.6kg
Volume: 10.54dm3

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.

REGULATION & CONFORMITY REQUIREMENTS
US FDA device listing as a Class I medical device (510(k) exempt).

SAFETY & PRODUCT STANDARDS
IEC 60601-1, IEC 60601-1-2, ISO 15004-1

NOMENCLATURE
GMDN©: 36386
EMDN: Z12120120