Transcript
Symbol Information
PT-5212
Symbol
Introduction
Referent In vitro diagnostic medical device Consult instructions for use
Digital Pregnancy Test
Temperature limitation
The PT-5212 Digital Pregnancy Test (for in vitro diagnostic) measures the amount of the pregnancy hormone, hCG (human chorionic gonadotropin) in urine. It is a rapid easy to use test, and provides results within 3-5 minutes after you apply the urine sample. This Digital Pregnancy Test is 99.04% accurate in detecting the pregnancy hormone in laboratory results when using 209 urine samples from pregnant and non-pregnant women. It is intended to be used on or after the first day of missed period. This package contains 2 digital pregnancy test meters and your owner's booklet. A 3V CR2032 lithium battery is pre-installed in the test meter.
Use by/ Expiry date
PLEASE READ ALL INSTRUCTIONS CAREFULLY BEFORE USE
Batch code Manufacturer Authorised representative in the European Community Serial number Caution, read accompany document
► For in vitro diagnostic use only. ► For self-testing. ► Store at 2°C - 30°C (35.6°F - 86°F). Do not freeze. ► Use this test at the room temperature. ► Use the test stick immediately after opening the foil wrapper. ► Keep dry and away from sunlight. ► Keep out of the reach of children. ► Do not reuse the test strip. Dispose of properly after use. ► Do not use the test strip after the expiration date printed on the package. ► Do not use your urine sample if it contains blood. Blood may affect accuracy of the test. ► This product only provides a preliminary test for pregnancy. You should contact your doctor for further diagnosis.
Start Testing Step 1
Remove the pregnancy test from the foil wrapper. Test Holder
Power Button Display Window
Cap
Owner’s Booklet
Step 2
30°C 2°C
For self-testing. Version 1.0 2012.11
Step 3
311-5212100-003
Absorbent Tip
► To obtain accurate results, please follow the procedures precisely.
Test Errors
Perform the test
Use a clean plastic or glass container to collect a urine sample. Press “(Power icon)” button to turn on the meter. While waiting for the sample or absorbing the sample the display will flash . Hold the test holder in a vertical position and immerse the entire absorbent tip into the sample for 10~15 seconds.
OR
Place the absorbent tip pointing downward and face up in your urine stream for 5-7 seconds.
Wait for 3~5 minutes
Absorbent Tip
After applying your urine, cover the strip with the cap and lay the strip flat on a clean, dry, non-absorbent surface. Never hold the test holder with the absorbent tip pointing upwards. The testing symbol will stop flashing while analyzing the test.
Result appears
OR
What to Do
Possible Cause ► Too much or too little urine was applied. ► The strip was not laid flat after urine was applied.
► Check the expiration date of the test stick. ► Test again with a new test stick and follow the instructions carefully.
► Problem in operation.
► Test again with a new test stick and follow the instructions carefully. If the display remains blank, please contact local customer services for assistance.
Using the Meter - Important Information ► The meter will automatically switch off if no urine is applied to the absorbing pad within 8 minutes after the meter is turned on. ► After the meter will not turn off after the measurement, the result will show on the display. ► We recommend that you should cover the cap and turn off the meter after viewing the test result in order to avoid the contamination.
Important Information About Test Results Test Holder Warning Do not hold the strip inversely.
Step 5
Error Message
Meter
► Any urine sample can be used for hCG testing. The first urine of the morning is ideal because it generally contains the highest concentration of hCG. ► Please perform the test immediately after urine collection. ► Do not use the urine sample if it appears cloudy or contains unusual particles or blood.
Step 4
Battery Compartment
Take off the cap.
After it stops flashing, the screen will display your result.
Before discard of the used test stick, please remove the battery by taking apart the rear cover from the strip stick. Dispose the battery and used test stick with the cap carefully according to your local applicable regulations.
Further Information Result Interpretation This indicates that you MAY be pregnant. You should see your doctor who can advise you on what steps you should take next. This indicates that you MAY NOT be pregnant, or the level of pregnancy hormone may not yet be high enough to be detected, or you may have miscalculated the day your period is due.
► False-negative results may occur when the level of pregnancy hormone in your urine is not high enough to be detected. If pregnancy is still suspected, you should wait a few days after the expected period and collect the first urine of the day and test again. Please remember to avoid large amounts of intake before testing. ► Medications containing hCG may affect the test result and should not be taken while using this test. Consult your physician before using this test. ► In some rare cases, women approaching menopause, or in menopause, may get false positive results with pregnancy tests because of presence of a hormone similar to hCG. See your doctor if you get a positive result. ► Ectopic pregnancy and ovarian cysts may cause misleading results. ► Some diseases or cancers may affect the result by interfering with pregnancy hormone production. If you have the above conditions, please contact your doctor before performing a pregnancy test.
Specification Model no.: PT-5212 Dimensions & Weight: 141 mm (L) x 26.5mm (W) x 16.2mm (H), 24g Operating Temperature: Allow to reach room temperature for 30 minutes prior to testing if stored refrigerated. The max operation temperature is 40 °C. Storage/Transport conditions: 2°C - 30°C (35.6°F - 86°F), below 85% R.H. This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-1-2, EN 61326.
