Reusable digital pregnancy test

Reusable digital pregnancy test
Product details
INTRODUCTION:
Digital Pregnancy Test is a rapid, qualitative detection of human chorionic gonadotropin (“HCG”) in urine, which is suitable for the early diagnosis of pregnancy. The equipment is a reusable self-test IVD medical equipment which is intended by the manufacturer for use by lay person in a home environment. This Test gives you reliable results within 5 minutes after testing your urine specimen.
HOW DOES IT WORK?
Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. Digital Pregnancy Test can detect tiny amounts of this hormone in your urine.
After suitable amount of urine specimen is applied to the test, the test directly displays the results of “+”, “-” or “?” in the display screen. It is an accurate, rapid, and convenient method for the early diagnosis of pregnancy.
ConTENT OF THE TEST KIT
One kit contains:
1 x Test Meter with 1 desiccant / pouch
5 x Sticks, 1 individual stick with 1 desiccant / pouch
1 x Instruction for use
Note: The desiccant is for storage purposes only, not used in the procedures.
WHAT ELSE DO YOU NEED?
A clean, dry, plastic or glass container to collect the urine and alcohol swab to clean the meter.
PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not swallow.
3. Keep out of the reach of children.
4. Do not reuse the stick.
5. Do not use the test kit after the expiration date.
6. Do not use the stick or the meter if the pouch is punctured or not well sealed.
7. Keep your hand dry and clean before and during test.
8. Do not use the equipment out of doors.
9. Protection impairment if used in a manner not specified by the manufacturer.
10. The procedures should be followed precisely for accurate results.
11. Do not use the sticks which are not from the same package of the meter.
12. Do not use the same device with other user.
13. Do not disassemble the battery. The battery is not detachable or changeable.
14. Do not freeze.
15. Please follow local regulations to discard used test sticks and test meter after used five times.
STORAGE AND STABILITY
1. Store at 4 ºC to 30 ºC in the sealed pouch up to the expiration date.
2. Keep away from direct sunlight, moisture and heat.
3. DO NOT FREEZE.
4. Preferably open the pouch only shortly before the test.
SPECIMEN COLLECTION AND PREPARATION
You can test in your urine stream directly, or the urine may be collected with a disposable urine cup or clean container and tested. Any urine specimen is appropriate for the test kit, the first morning urine is optimal, because generally contains the highest concentration of HCG in specimen.
Please perform the test immediately after urine collection. If the urine specimen cannot be detected immediately, it should be stored at 4ºC, and recover to room temperature before use. Urine stored for longer than 2 days is not suitable for the test.
Caution:
Please do not use the urine specimen if the urine appears turbid or contains unknown matters.
HOW TO DO THE TEST?
Note: Do not remove the stick from the pouch until you are ready to use. To begin testing, read the instruction thoroughly, and do the test under room temperature (10 ºC~30ºC).
STEP 1: Remove the pouch
1)Take a Test Meter and Stick out of each pouch by tearing at the notch, respectively.
2)Please check if there is any spot or damage on Result Area of the stick. Don’t remove the cap before insertion or touch the Result Area in the stick with the hand.
STEP 2: Stick insertion
1)Insert the stick into meter as stick arrow indicates, until the meter automatically turns on with a beep and the Testing Symbol will flash on the screen.
2)A few seconds later, the Testing Symbol stops flashing with three beeps.
Caution
1)Please make sure that the stick will be locked with a beep in the meter.
2) Please check if the Testing Symbol displays on the screen before applying your urine.
STEP 3: Remove the cap
1)Remove the cap of the stick carefully and slowly to prevent the stick unlocked.
2)Check if any spot or damage on the strip. Don’t touch the strip, or it may influence the test result.
3)Check if the Testing Symbol remains on the screen.
4)The meter is ready for a pregnancy test.
STEP 4: Conduct the test
You can choose to conduct the test either in urine stream or with specimens in container:
Throughout the testing never hold the testing device with the stick pointing upwards (Fig. 1).
#1. Test in Urine Stream
Hold the meter with stick pointing downwards in your urine stream (Fig. 2). Keep over half of strip in urine stream for 5~10s. Do not urinate to the meter.
OR
#2. Test with Specimens in Container
Collect your urine into a clean and dry cup. Dip over half of strip into the urine for 5~10s (Fig. 3). Take care not to get the meter wet.
STEP 5: Wait
1)Remove the meter from the urine stream or urine in container, and then keep the strip pointing downwards or lay the Test Meter flat. You may wish to replace the cap.
2)The Hour Glass symbol starts flashing within 90s to
show the test is working (Fig. 4). If the Hour Glass symbol does not appear after you have used the test, refer to Q3 in the QUESTIONS & ANSWERS.
STEP 6: Read your result
Within 5 minutes, you will hear three beeps and the screen will show your result. Please see HOW TO READ THE RESULT.
STEP 7: Eject the used stick
After the test is finished, hold down “Eject” button to eject the used stick and deal with it as local regulations. The result remains displaying for 12 hours or until another new stick is inserted for new test.
HOW TO READ THE RESULTS?
Positive (Pregnant):
When the display screen displays “+”, it indicates that you are pregnant.
Negative (Not Pregnant):
When the display screen displays “-”, it indicates that no pregnancy has been detected.
Invalid (Error):
When the display screen displays “?”, it indicates that the test fails or is invalid. Please see ERROR MESSAGE.
SPECIFICATION
Power Supply:3Vdc(CR 2032 lithium battery x 1)
Sensitivity:25 mIU/ml
Read Time:5 minutes
Storage and Transport condition:4ºC~30ºC
Operating condition:10ºC~30ºC
QUESTIONS & ANSWERS
1. How accurate is the Digital Pregnancy Test?
The Digital Pregnancy Test has been shown in extensive laboratory trials to be over 99% accurate in detecting the HCG. The sensitivity of the Test is 25 IU/L.
2. When should I test with a Digital Pregnancy Test?
Normally the Digital Pregnancy Test can be used 2 days before your expected period.
3. Which time of urine is best for the detection?
Any urine specimen is appropriate for pregnancy testing but the first morning urine specimen is optimal because of its highest concentration of HCG.
4. Could any medication or medical conditions affect the result?
Always read the manufacturer’s instructions for any medication you are taking before conducting the test. Fertility drugs containing HCG can give misleading results. These fertility drugs are usually given by injection, and testing too soon after the administration may give a false “Pregnant” result. Other fertility therapies, painkillers and hormonal contraceptive (e.g. birth control pills) are unlikely to affect the result.
If you are in or approaching the menopause you may obtain a false positive result even though you are not pregnant.
Ectopic pregnancy and ovarian cysts can give misleading results.
If you get unexpected results you should discuss them with your doctor.
5. What should I do when my Test says I’ m Pregnant?
If your result is “Pregnant”, you should see your doctor who can advise you on what steps you should take next.
6. What should I do when my Test says I’m Not Pregnant?
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. If you tested early, test again when your period is due. If your period is overdue, test again within 7 days. If this test gives you a “Not Pregnant” result and you still have not had your period, see your doctor to eliminate the Gynecological diseases.
7. Do I need to use all sticks?
No. You can stop testing when you finished detecting your HCG.
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