Digy Personal Test PIC

Device suitable for the early diagnosis of pregnancy, which allows d1 to perform rapid tests based on the quantitative determination of human chorionic gonadotropin ("hCG") in urine. It is an in vitro diagnostic (IVD) device for self-diagnosis.
The device detects concentrations of 25 mIU / ml or more in urine.
Specificity was determined by cross-reactivity studies with known amounts of luteinized hormone (LH), follicle stimulating hormone (FSH) and thyroid stimulating hormone (TSH). Negative results were obtained in all tests conducted with 500mIU / mL of LH, 1,000mIU / mL of FSH and 1,000mIU / mL of TSH.

How to use

Sample collection and preparation
To perform the test it is possible to hold the absorbent part directly under the urine stream, or to collect the urine in a suitable disposable container or in another clean container for the subsequent execution of the test. The kit can be used with any urine sample. If the test cannot be performed immediately, the specimen should be stored at 4 ° C, and returned to room temperature before use. To perform the test correctly, urine should not be stored for longer than 2 days.

Test procedure

Do not take the device out of the pouch until you are ready to test. Before performing the test, please read the instructions carefully. The test must be performed at room temperature.
1. Remove a test device from the pouch by tearing it off at the invitation. Grasping the handle with one hand, remove the cap with the other, to reveal the absorbent tip. Never hold the device with the absorbent tip pointing upwards for the duration of the procedure.
2. You can choose whether to perform the test directly under the urine stream or to use a urine sample previously collected in a container.
- Urine jet test:
Keep the absorbent tip pointing downwards under the stream of urine. Do not urinate on parts other than the absorbent tip. During sample collection, the device should be kept tilted at an angle greater than 45 degrees. The hourglass symbol will appear on the display. Within 10 seconds you will hear a beep and the hourglass symbol will start flashing. Remove the device from the urine stream and keep the absorbent tip pointing downwards, or place the device horizontally on a flat surface. If desired, the cap can be closed again.
- Test with sample collected in a container:
Collect urine in a clean, dry container. Completely immerse the absorbent tip in the urine. Be careful not to get the test device wet. The hourglass symbol will appear on the display. Within 10 seconds you will hear a beep and the hourglass symbol will start flashing. Remove the device from the urine and keep the absorbent tip pointing down, or place the device horizontally on a flat surface. If desired, the cap can be closed again.
3. The hourglass symbol will continue to flash to indicate that the test is in progress. Within 5 minutes you will hear a second beep and the hourglass symbol will stop flashing. Then the result will appear on the display.
Possible results are: Not Pregnant, Pregnant, and Error. In the latter case, the test was not performed correctly, the result is invalid or the device was used. Then repeat the test with a new device.
If the hourglass symbol does not appear after using the test, consult the user manual.

Warnings

For in vitro diagnostic use only. For external use only. Do not swallow. Dispose of after first use. It cannot be reused for other tests. Do not use the test kit after the expiration date. Do not use the kit if the housing is punctured or not hermetically sealed. Keep out of reach of children. Before performing the test, wash and dry your hands, which must remain clean and dry throughout the procedure. Do not use the product outdoors. In order to obtain precise results, it is necessary to strictly follow the instructions. The battery cannot be replaced. Follow local regulations when disposing of used test devices. Do not freeze.
As with any diagnostic procedure, confirmation of pregnancy can only be done by a physician following an evaluation of all required clinical and laboratory findings. The device is only suitable for use with human urine. If the urine sample is too diluted, the amount of hCG it contains may be insufficient. If pregnancy continues to be suspected, collect another urine sample after at least 48 hours. Then run the test again. A low concentration of hCG at an early stage of pregnancy can lead to a negative result. If so, repeat the test with a new urine sample after at least 48 hours. Medical procedures based on the use of hCG, such as fertility therapies, can lead to an erroneous result. Consult your doctor. Note that even using an unclean container or carrying out the procedure incorrectly could distort the result.

storage

Store at a temperature between 4 ° C and 30 ° C. Avoid direct exposure to sunlight, humidity and heat.

Format

1 piece.

Cod. 0202301200000