Photo screener, portable

GENERAL DESCRIPTION
Portable handheld device used for rapid vision screening to detect refractive errors (myopia, hyperopia, astigmatism), eye misalignment, and unequal pupil size. Suitable for mass vision screening programmes.

INTENDED USE
For use by trained personnel to measure retinal light reflexes and estimate refractive power, pupil size, pupil distance, and gaze deviation in individuals aged 6 months or older.

TECHNICAL SPECIFICATIONS
Handheld, portable device that uses infrared imaging to capture retinal reflexes from non-dilated eyes.
Classified as Type I laser product (near infrared range: 800nm～880nm).
Supports monocular and binocular measurements.
Pupil size range: 4.0mm to 9.0mm
Pupil distance range: 30 to 80mm
Fixation angle: 0-20°.
Measurement range: spherical -9D to +7D, cylindrical 0D to 3D, axis 0-180°
Detects ocular misalignment up to 3 prismatic dioptres.
Measuring time: approx. 1 second after focus.
Display: 4.3inch LCD colour touch screen.
Optional sound and flashing light fixation target to attract children.
Power supply: 2 x 18650 rechargeable Li-ion batteries.
External power adaptor: 100-240VAC, 50/60Hz, USB output.

SUPPLIED WITH
Instructions for use and maintenance in English, French and Spanish.
1 x storage/transport case
1 x printer
1 x external power adaptor

ESTIMATED LIFE SPAN
4 years

WARRANTY
2 years

ENVIRONMENTAL CONDITIONS
Operating conditions: 5 to 40C/ ≤ 90% relative humidity
Storage conditions: -40 to 55C/ ≤ 90% relative humidity

WEIGHT AND VOLUME
Weight: 4kg
Volume: 23dm3

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices - Quality management systems — Requirements for regulatory purposes.
Supplier is certified to ISO 9001 Quality management systems – Requirements.

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

NOMENCLATURE
EMDN: Z1212012080