| Project | Technical indicators |
| Measurement principle | A reflectance photometer is used to measure the color change of urine test strips, calculate the concentration values of relevant items, and output semi-quantitative results. |
| Test performance |
Optical automatic sensing test strip for automated sample injection; Repeatability coefficient of variation (CV) ≤ 1%; Difference from the quality control solution label value is within one order of magnitude in the same direction, with no reverse difference; Stability coefficient of variation (CV) ≤ 1%; Removable tray for easy cleaning and maintenance; No cross-contamination between samples. |
| Test wavelength | 470nm、525nm、625nm |
| Test speed | 514 specimens/hour |
| Reporting methods |
LCD display; serial port output; Built-in 57mm thermal printer, Chinese and English selectable; |
| LCD display | 320×240 dot matrix LCD; |
| Input method | Touchscreen input; |
| Report storage | It can store 5,000 test reports; |
| External Interface | Standard RS-232 serial port; |
| Operating voltage | AC220V 50Hz |
| Instrument power consumption | No more than 45VA; |
| External dimensions | 390×330×210mm |
| Instrument weight | 6kg |
| Power cord | 1.5m |
| Basic performance claims of electromagnetic compatibility testing | Repeatability: The coefficient of variation (CV, %) of the reflectance test results from the analyzer is ≤1.0 |
Intended Use: This product is used in conjunction with the accompanying urinalysis test strips for urine chemical analysis in clinical laboratories of medical institutions. It is intended for semi-quantitative or quantitative analysis of multiple chemical components in human urine specimens.
Testable items typically include: glucose (GLU), bilirubin (BIL), ketone bodies (KET), specific gravity (SG), occult blood (BLD), pH (pH), protein (PRO), urobilinogen (URO), nitrite (NIT), white blood cells (LEU), ascorbic acid (ASC), urine calcium (uCA), creatinine (CRE), and microalbumin (MAU).
Product structure: This product consists of a shell, power supply, motion transmission part, measurement part (light source, light receiver), control calculation part (computer system), input (keyboard or touch screen) output (liquid crystal) and interface part (serial port).
Precautions for Use:
1. This product is intended for auxiliary diagnostic purposes only and does not replace a physician's final diagnosis.
2. We recommend the use of our company's designated test strips, which have obtained a registered medical device certificate. Using other brands of test strips may result in skewed test results.
3. Operators must be trained professional inspectors.
4. Installation Environment: The device should be installed in a stable, vibration-free, light-proof, and electromagnetic interference-free environment, and in a clean, dry place.
5. Use fresh, uncontaminated urine samples, and complete the test within the specified timeframe.
6. Daily Maintenance: Calibration and quality control must be performed according to operating procedures. Regular maintenance and repairs must be performed and recorded.
7. Electrical Safety: Before connecting the power supply, ensure the voltage is correct. If any leakage occurs, discontinue use immediately.
8. Troubleshooting: If a malfunction or uncontrolled quality control results occur, discontinue use immediately, investigate the cause, and contact maintenance personnel if necessary.
Contraindications:
1. Those who drink large amounts of water or are severely dehydrated.
2. People with poor eyesight who are unable to operate the machine.
3. Those who take unknown medications.
4. This product is only for testing fresh urine.
Please read the product instructions carefully or purchase and use under the guidance of medical personnel.
For contraindications or precautions, please refer to the instruction manual.