I-TEAR TEST

STRIP MENISCOMETRY TUBE

QUANTITATIVE TEAR FUNCTION TEST

DEVICE DESCRIPTION

I-TEAR^® TEST Strip Meniscometry Tube is a rapid 5 second test of the tear function of each eye, using a single-use sterile strip. When the I-TEAR^® TEST is applied to the lateral lower lid tear meniscus of an eye, it absorbs tears via the capillary action of absorber present in the center of the strip. The indicator, placed at the end of the strip, is dissolved in the absorbed tear. After 5 seconds, the length of the stained tear column is marked and read to evaluate tear meniscus volume.

INTENDED USE

For use under the supervision of a licensed veterinarian. I-TEAR^® TEST is a device applied into a tear meniscus for in vivo examination to assess the tear volume.

CONFIGURATION, STRUCTURE

1. Configuration Structure: I-TEAR^® TEST is thin strip with a central ditch filled with absorber. Scale is printed on both sides of the absorber to measure the tear volume. Each I-TEAR^® TEST is packaged individually in sterile pouch.

2. Size: Length: 85mm, Width: 7mm, Height: 0.3mm

3. Material:

Indicator: Blue dye 1

Tape: Polyurethane, Polyester

Backing: Polyurethane

Absorber material: Rayon, Pulp

Absorbent area (tube structure): Filled with absorber material

SPECIFICATION

1. Appearance: No damage, no dirt, no foreign material is attached.

2. Sterility assurance level (SAL) 10^-6

PACKAGE

Box contains 50 individually packed sterile strips. Each strip is used for both eyes.

DEGREE OF ACCURACY

Device error within ±1.2 mm.

DIRECTION FOR USE

1. Carefully open the transparent, sterile pouch at either of the ends of the pouch as to not damage the device.

2. Hold in the center of I-TEAR^® TEST strip as indicated in the adjacent diagram [A]. Do not touch the tips of the strip containing the blue dye area.

3. Apply the tip of the I-TEAR^® TEST of R mark portion on the right eye for 5 seconds to the lateral lower lid tear meniscus without touching the cornea and conjunctiva [B].

4. Measure the length of the stained tear column, marking by a pen [C].

5. Repeat the same procedure of L mark portion tip on the left eye.

INTERPRETATION OF THE TEST RESULT

Blue-stained column length reflects the amount of absorbed tear in a proportional manner. The blue-stained column length of approximately 8mm or more is considered as normal, while the length shorter than 8mm is considered as small amount of tear meniscus volume.

WARNINGS

I-TEAR^® TEST strip is not meant to be applied to the cornea and conjunctiva. Single use only. Do not re-use.

PRECAUTIONS

Do not use if the I-TEAR^® TEST strip is damaged or contaminated. Dispose of it in a safe manner to prevent infection after use. If eye drops have been used, the test should be performed at least 60 minutes later.

KEEP AWAY FROM SUNLIGHT. SINGLE USE ONLY. DO NOT REUSE. DO NOT USE IF STRIP IS DAMAGED OR CONTAMINATED. STERILIZED USING RADIATION.

Manufactured in Japan by Echo Electricity Co. Ltd. for I-MED Pharma Inc.

I-TEAR is a registered trademark of I-MED Pharma Inc.

©2022 I-MED Pharma Inc.

I-MED ANIMAL HEALTH, 7190 Frederick Banting Rd., St. Laurent, QC, Canada H4S 2A1

(514) 685-8118

info@imedanimalhealth.com

REF: 630

I-TTIFU 0322

imedanimalhealth.com

CPN: 1451009.2