Self Vision Tester

Primary DI
08800074500213
Brand
Self Vision Tester
Company
VIEW-M TECHNOLOGY CO., LTD.
Model
VAA-2000PCE
Catalog number
VAA-2000PCE
Device description
When users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.) through the tester’s eyepiece, users keep eyes on the indication in the middle of background and the indications on every sides. Then move the lever to the same indication to the indication in the middle. If users cannot distinguish the indications, push on of the red buttons on the left and right sides to forgive. Then it skips the phase and change to next indication. When the exam finished, the device analyzes user’s choices and give the result data of the exam. Users can check their eyesight data by printing it from device. In addition, the device prevents user’s mistake by voice guidanceTo start the color-blindness test, touch the 10.1-inch LCD touch-screen at the top of the device. The indications on the center of the screen are displayed on the LCD touch screen. Touch the displayed indication by one-step multiple-choice color vision test, and then the same type of color vision test will be performed in several steps. Users touch the LCD screen to proceed with the test, the test will be completed. After the test is completed, you can print out the results of the color test on the print paper by touching the print button on the touch screen.
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800074500213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800074500213088000745002138800074500213

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training chartAn ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557821283
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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