SEEIN S1 Colloidal Gold Immunochromatographic Test Strip Monitor User Manual
- June 5, 2024
- SEEIN
Table of Contents
Colloidal Gold Immunochromatographic
Test Strip Monitor
Connecting to the app
Search for and download Seein from the app store ( available for both Android and iPhone ), and open the app for account registration. After registration, you will receive an activation email. Activate the account based on the prompts. Then, you can link your device to the app according to the prompts. Successfully linked, the app will read your test results, automatically prompt for test times, record each measurement, and tell you the best time for sexual activity and the probability of conception. It will also provide a detailed monthly report and corresponding pregnancy preparation recommendations based on data such as menstruation and hormone levels.
Q &A of APP
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What to do if app connection fails?
Restart the device, or re-connect to the app via Bluetooth. -
What to do if the test results are neither synced to the app nor displayed on the screen?
Try reconnecting the device to the app or re-open the monitor. -
How does the app get the information about my menstrual cycle?
The app calculates user menstrual cycles intelligently based on user selections and descriptions, and measured hormone data. -
Is data for each test automatically synced to the app?
Can data for multiple measurements be synced to the device at the same time?
If your device is connected to mobile Bluetooth, the data will be synced to the app after each test. If you forget to sync the data once, the next time Bluetooth is turned on and the app is reconnected to the device, the data for multiple measurements will be automatically synced. -
Is Internet or Wi-Fi needed to run the app?
It is better to connect to the network to run the app, in order to sync your test data to the cloud system to more conveniently manage your historical data. -
How many tests can be stored in the app?
It can store data on 50 tests. If there are more than 50 test data without synchronization to app, the oldest data will be replaced to newest data. -
Will tests conducted in different time zones affect the calculation results?
It won’t affect the calculation results but will affect the test time. Once the mobile app is connected to the device after changing the time zone, the time zone information is automatically synched to the device. -
If I change my phone, will the previous test data be lost? Will it affect my test results?
Previous data will not be lost, and it will not affect your test results. Once your phone is connected to the network, the test results will be encrypted and synchronously transmitted to your exclusive cloud server. After you change your phone and log into your account again, the data will be synchronized to your phone.
Testing Principles
This device quantitatively detects the content of different substances in different samples by testing the reagents produced using the double antibody sandwich method and nano-gold lateral immunochromatographic assays. The reagents are the mouse anti-LH2 monoclonal antibody and goat anti-mouse IgG polyclonal antibody-coated and paired at the detection and quality control lines on the nitrocellulose membrane through making a mouse anti-LH1 monoclonal antibody coupled to colloidal gold as a chromogenic marker. During the detection, if human luteinizing hormone exists in the sample, it reacts first with the gold-labeled antibody conjugate to form gold-labeled mouse anti- LH1 + LH, which is chromatographed under the capillary effect. The gold- labeled mouse anti- LH1 + LH and mouse anti- LH2 form gold-labeled mouse anti- LH1+LH+ mouse anti-LH2 compound in the test area ( T line ), and a burgundy red strip appears. As the LH content increases, the color of the strip also becomes darker. The remaining part continues on into the control area ( line C ) to form gold-labeled mouse anti-LH1+goat anti-mouse IgG compound, and a burgundy red strip appears. Collecting sufficient samples to be tested ensures the effectiveness of the regent, and it is inserted into the lateral immunochromatographic analysis. The signal change of the regent test card is detected by the optical detector of the analyzer, and the content of the substance is calculated based on standard curves.
Precautions
- Invalid results: If the quality control line does not appear, take the test again. (There are two lines in the strip. The upper line is called control line and the bottom one is called test line. If the control line is missing, the strip is invalid.)
- When the result exceeds the normal range3-70mIU/ml), it is recommended to first confirm whether impurities have been introduced. If the result is confirmed, see a medical professional for comprehensive reproductive endocrine examination.
- The reagent strip can be used to directly collect urine samples. The best sample is in the middle section of the stream.
- Do not keep the reagent after sample collection at room temperature (68-77°F) for over 4 hours.
- If the charging cable of this product is damaged, it can be replaced with any charging cable of the same model that meets the specifications.
- During the startup process, do not insert the reagent strip when the device starts to reset and self-check.
This product contains Device ×1 USB Cable ×1 Manual ×1 Warranty card ×1
The Minimum Detection Limit 5mIU/ml Accuracy: CV20% Battery Capacity: 650mah Bluetooth: 5.0 Input Voltage: DC 5V Rated Current: 1A
Specifications
This product contains
Device ×1
USB Cable ×1
Manual ×1
Warranty card ×1
The Minimum Detection Limit： 5mIU/ml
Accuracy: CV≤20%
Battery Capacity: 650mah
Bluetooth: 5.0
Input Voltage: DC 5V
Rated Current: 1A
Button Operation
- Power on/off: in the shutdown state, press and hold the button for 3 seconds, the device starts In the power-on state, press and hold the Down button for 3 seconds, the device is shutting down.
- Menu operation: you can select different menus by the up button
- Items confirmation: you can confirm by the down button after select the menu.
- Abnormal handling: In case of abnormal operation, press the up and down buttons simultaneously for 7 seconds, the device will automatically restart.
- Breath screen: After 5 minutes of inactivity, the device will automatically turn off the screen. You can press any key to light the screen.
- Automatic shutdown: After 10 minutes of inactivity, the device goes shutting down.
Usage Instructions
Operating Condition: 41-104, Relative Humidity90% Step
Step 1: Log into your account on the app. For the first time to use, please complete the registration and finish the relevant personal health information according to the prompts. The APP will give you test schedule intelligently.
Step 2: Turn on the monitor based on its operating manual, and connect to the app via Bluetooth
Step 3: Before opening each box of reagent strips, scan the QR code on the box using the QR code function in the app to calibrate the reagent calibration curve.
Please use at room temperature
Step 4: Open the reagent box and remove the detection card from the sealed aluminum foil bag. Urine can be directly absorbed through the reagent strip, and the best sample is in the middle section of the stream. (Note: mid- stream urine is urine discharged in the middle of urination, removing interference from the initial and final urine).
Step 5: After 5 minutes of urine absorption, discard the shell and urine absorption portion.
Step 6: Observe whether the red quality control line appears near the handle in the middle window of the reagent detection card. If it does appear, the test is normal; If it does not, the test has failed and a re-test is required. If the operation process is normal, the sample is large enough, and the sample and reagent detection card are normal in nitrocellulose membrane chromatography, the quality control line will display normally.
Step 7: Sync the data to the app and read the result. Users could get hormone curves and monthly reports after multiple measurements.
Step 8: Finally, long press for 3 seconds to shut down and discard the used reagent strip into the trash.
Failures that users can resolve themselves
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Instrument does not respond
Low power: please recharge the battery and restart the instrument; Power switch not on: please turn on the power; Device damaged: please contact after- sales service for replacement. -
The procedure has been completed but no results are displayed.
Device is still testing and calculating: please wait for this process to be completed. Issue encountered during testing: please restart the device and test again. -
Abnormal display
Static electricity is affecting the display: please restart the device; Circuit failure: please contact after-sales service for replacement. -
Display information: Test error
Invalid reagent strip leading to invalid test: please replace the reagent strip and perform the test again -
Display information: 10 tests have been conducted.
For reagent kit replacement, please scan the QR code again
There are ten reagent strips in each kit.
Please scan the QR code again. -
Auto shutdown due to overheating
If the temperature inside the device is higher than 70°C > the device will be shut down. When the temperature is lower than 40°C » please press open button to reopen the device.
Note: When not in use for a long time, please fully charge and store in a dry and ventilated environment.
Warning: Keep away from fire and avoid direct sunlight.
Q&A
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Will the results of each test be displayed on the device screen?
Yes. The results of each test will be displayed on the device screen 10 seconds after completion of the test. -
Is the device waterproof?
This device is liquid-resistant, but cannot be immersed in liquid. -
Do I need to redo Bluetooth pairing to sync the data each time?
No. The test device and app only need to be manually paired for the first time. During subsequent use, as long as the phone’s Bluetooth is turned on, pairing and data synchronization will be automatic. -
Can one device be used by multiple users?
Sorry, it can only be used by one user. -
Why do the calculation results become more accurate with more measurements?
With more measurements, Seein modifies the results curve according to its big data algorithm, making the results more consistent with actual hormone secretion curves. -
Can I still use the test if my periods are irregular or I have PCOS?
You can use the test, but the results may be affected. -
Should the test be conducted every day? What’s the test frequency?
The test does not necessarily need to be done every day. Seein recommends different test times in accordance with each user’s need, so the frequency will vary from person to person. Generally, the number of tests per cycle will not exceed 10. -
Does each day’s test need to be at the same time?
No. We will predict corresponding test time ranges for each user, So users only need to follow the guidance. -
Can I use other brands of test strip with Seein’s devices and app?
No. Seein test strips must be used. -
When should I start testing when using the product for the first time? How do I do the test if I don’t know the last menstruation period?
Generally, when the user knows the exact time of the last menstruation, we recommend the test time based on our algorithm and the user’s historical information. However, if you are not sure about your menstruation, we suggest recording your next period and then testing according to the recommendation. It is generally recommended that users conduct higher frequency tests when using the product for the first time, which helps improve the intercourse prediction accuracy. -
Can Seein do early pregnancy tests?
Not for now. We will develop early pregnancy test strips soon -
What is the definition of Seein’s quantitative test?
What do the numbers represent?
Quantitative testing refers to the specific hormones in the urine sample measured through the test, mainly representing their concentration. Using these specific concentrations, Seein offers users more scientific guidance. -
Can I use morning urine for the test?
How does it affect the test?
It is not suggested to use morning urine to test, because the concentration of hormones is higher than normal.
Testing with morning urine interferes with measurement and prediction of the ovulation period, resulting in inaccurate measurement of intercourse time. -
Will the test result change if I miss the recommended time?
The recommended test time is the optimal test time, and if you miss it, you may miss the optimal intercourse time. If you have missed the recommended time, do the test as soon as possible after not drinking water for two hours.
If any of the above conditions occur, wrong hormone secretion peak prompts may appear. Please do the test as soon as possible after meeting the drinking water condition. -
How accurate is Seein’s intelligent testing system?
According to the laboratory test data and based on medical device requirements, this device meets the CV<15% and 99% LH peak value detection accuracy requirements. -
Why do my indicators differ from those of others?
Why is there an LH surge in my test results?
Each person’s physical condition is different, so there is a normal range of hormone levels. The reason for not detecting the rise may be endocrine problems, data errors caused by drinking too much water, or wrong testing times. -
Why there is high-to-low fluctuation in my test results during the hormone surge process?
There may be several reasons: 1. Interference on the test results, such as by drinking water, reduces the concentration; 2. Error in the device if the interval between two tests is too close (small fluctuations); 3. Interference from hormone drugs. -
Does medical treatment influence the test results?
Please read the operation instructions and drug instructions when using Seein. Some drugs or changes in one’s condition may interfere with the testing results.
The following drugs may influence the results:
Hormone contraceptive pills;
Hormone drugs for polycystic ovarian syndrome;
Hormone drugs for ovulation induction;
Hormone drugs to alleviate climacteric symptoms;
Other hormone drugs;
Antibiotics with tetracycline, etc. -
How should I handle the test strip and device after use?
All waste after testing, including test cards and urine cups, etc. is considered infectious and should be treated in accordance with current regulations and requirements.
When the testing device reaches the end of its life, it should be treated in accordance with the requirements by the local environmental protection department, and must not be handled or discarded as general waste. -
Can test devices and reagent strips be bought separately?
Yes. We have prepared kits with test devices and containing only reagent strips (without the test device) for convenient individual purchase. -
I’ve been using the device for several months; why haven’t I gotten pregnant?
For healthy couples, intercourse at the proper time greatly increases the chance of fertilization, but itis not 100% guaranteed. Pregnancy also depends on the physical condition and age of both the husband and wife, as well as ovarian reserve function and sperm quality. If you are less than 35 years old and try to conceive for 12 months without success, we suggest consulting a doctor for a comprehensive examination. If you are over 35 years old, prepare for pregnancy under the guidance of the doctor. -
How many test strips will I use in a month?
Can I buy additional strips?
Usually 7-10 test strips are used a month, but the number varies between users.
Additional strips are available for purchase.
Note of FCC :
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
Registrant: Shenzhen Zaitian Yifang Technology Co., Ltd.
Enterprise address: 606Q, 6F, Xuyuan Building,
No.5003 Long Gang Road, Nanlian Long Gang District,
Shenzhen Guangdong, China
Manufacturer: Shenzhen Ruizhigu Medical Technology Co., Ltd.
Production address: B101, 201, 301, 302, 303, 2402,
Smart Home Phase II, No. 76 Bao He Avenue, Bao Long Community,
Bao Long Street, Long Gang District, Shenzhen Guangdong, China MADE IN
CHINA
For More Information, please contact service@seeinhealth.com
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