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Idiomas disponibles
Idiomas disponibles
Technical information
Technical description
The autorefraction system is based on wavefront aberrometry, a technology currently used in benchtop
wavefront aberrometers to measure low- and high-order refractive (wavefront) errors and to guide LASIK
surgery. The specific implementation of this technique in the devices enables the user to obtain an open-
view autorefraction.
The keratometry system included in the QuickSee Free Pro Keratometry medical device determines corneal
curvature by analyzing reflections of an illumination source off the cornea.
Measurement environment
The QuickSee Free medical devices can be used indoors or outdoors. Be sure to eliminate or block any
sources of sunlight and/or light that may shine onto the patient's eyes during the measurement.
The device is designed to work in the following environmental conditions:
•
Ambient temperature range: -10 – 37.5 ˚C (14 – 99.5 ˚F)
•
Relative humidity range:
•
Atmospheric pressure:
NOTE: A minimum pupil size of 2 mm is recommended for measurements to be taken. It may be difficult to
take a measurement in an environment with a bright light source that causes the pupil to constrict smaller
than 2 mm. For best results, subject's pupils should be between 2 mm and 8 mm.
Transport and storage conditions
The QuickSee Free medical devices can be transported and stored in the following conditions:
•
Ambient temperature range: -5 – 50 ˚C (23 – 122 ˚F)
•
Relative humidity range:
•
Atmospheric pressure:
Environmental protection
QuickSee Free medical devices contain Lithium-ion cells and other electronic materials. Please contact
your local government authorities and consult with relevant laws for proper electronic disposal methods or
recycling at device end of life.
Servicing and technical documents
This documentation is part of the technical file of the QuickSee Free medical devices. PlenOptika will make
available on request circuit diagrams, component part lists, descriptions, or other information that will assist
PlenOptika authorized Service Personnel to repair the QuickSee Free medical devices.
EMC information
The QuickSee Free medical devices conform to the most widely accepted EMC standard, the UNE-EN
60601-1-2:2015. The device has been tested and found to comply with the limits for Group 1, Class A medi-
cal device (RF Emission CISPR 11), pursuant to Part 15 of the FCC Rules.
Electromagnetic compatibility
The QuickSee Free medical devices are suitable for use in all establishments other than domestic settings
and may be used in domestic settings and those connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes, provided the following warnings are heeded.
•
Warning: This equipment is intended for use by healthcare professionals or under the supervision of
healthcare professionals only. This equipment may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating
the QuickSee Free or shielding the location.
30 – 90%
800 – 1060hpa
less than 80%
800 – 1060hpa
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