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Medical Device
New method for Tear Volume Measurement
Only 5 seconds!
Dry Eye Screening
5 seconds quantification for the lower tear meniscus volume
Swiftness; only 5 seconds per eye
Minimally Invasive, No anesthetic required
Handiness
FDA, CE, KFDA registration
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New diagnostic medical device, "Strip Meniscometry Tube(SMTube)", developed for a simple, accurate, swift and minimally-invasive assessment of tear volume.
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It has been reported that the strip meniscometry testing was useful in the diagnosis of dry eye disease, showing a statistically significant correlation with other ocular surface examinations such as the Schirmer test, tear film break-up time measurement, and vital staining scored (Ibrahim, 2011).
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SMTube is a product to perform the strip meniscometry testing, developed with an appropriate standardization and mass-production techniques, with intent to help medical staff carry out the testing with ease and accuracy.
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Since SMTube is used right on ocular surfaces, the safety is highly considered;
The material and structure were carefully chosen and designed so that no damage ought to occur on the ocular surface in case the tip of the strip touches cornea or conjunctiva.
Comparison with a Existing Lacrimal Test
Existing method : Schirmer's test
SMTube
Inserting the Schirmer Strip
inside the lower eyelid (Conjunctuval Sac)
Usage
Immersing the SM Tube
into the tear meniscus liquid
5 minutes
Invasive
Required time
Algia
5 seconds
Non-invasive
SMTube Shape
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Immerse the tip of the SMTube strip into the tear meniscus of the lower eyelid for 5 seconds.
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The length of stained column quantifies the tear meniscus volume.
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The column will be stained with blue dye as the SMTube absords tears.
Product Information
KFDA(Korea FDA) device registered as Class I
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Manufacturer :
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Country of Origin : Japan
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ISO 13485:2003, ENISO13485:2012 certified
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Package : 50 strips/box
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Pouch : Each SM Tube is individually sterillized
MHLW Japan registered as Class I medical device
FDA device registered as Class I
European Medical Device Directive 93/42/EEC, CE marked as Class I
PCT patented
SINGLE USE ONLY