ใบรับแจ้งรายการละเอียด เลขที่ 66-2-3-3-0006690
อ่านคำเตือนในฉลากและเอกสารกำกับเครื่องมือแพทย์ก่อนใช้
Warning
- Installation by personnel not authorized or trained by Sinseng may cause personal injury or damage your analyzer. Do not install your analyzer without the presence of Sinseng-authorized personnel.
- The installation, authorization, upgrade and modification of the analyzer software must be performed by Sinseng-authorized personnel.
- There should be enough room on and below the countertop to accommodate the reagents and waste containers.
- The diluent container shall be put within 1.0m under the analyzer, lyse containers are placed inside the analyzer.
- The countertop (or the floor) where the analyzer is placed shall be able to withstand at least 40kg of weight.
- Make sure the analyzer is properly grounded.
- Before turning on the analyzer, make sure the input voltage meets the requirements.
- Installation by personnel not authorized or trained by Sinseng may cause personal injury or damage your analyzer. Do not install your analyzer without the presence of Sinseng-authorized personnel or local distributor.
- Do not contact the patients' sample blood directly.
- Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
- The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
- If reagents accidentally spill on your skin or into your eyes, rinse the area with plenty of clean water and seek medical attention immediately.
- Keep your clothes, hairs and hands away from the moving parts to avoid injury.
- The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
- The sample probe is sharp and potentially biohazardous. Do not contact the sample probe during operations.
- The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Precautions
- Using pinboard may bring the electrical interference and the analysis results may be unreliable. Please place the analyzer near the electrical outlet to avoid using the pinboard.
- Please use the original power cable shipped with the analyzer. Using other power cable may damage the analyzer or cause unreliable analysis results.
- The analyzer performance may be declined if it has been placed in environment of high dustiness.
- The surface of the analyzer shall be cleaned and sterilized regularly with alcohol (75%).
- The aspirate key of the analyzer (see Figure 3-1 Front view of the analyzer) shall be wiped with alcohol (75%) regularly.
- Sample collection and preparation must be done following standard procedures.
- If any of the pipes or fluidic components is worn out, stop using the analyzer and contact Sinseng customer service department immediately for inspection or replacement.
- Check and make sure the pipes of reagents, including diluent, lyse and waste, are not pressed or bent.
- You must only use the Sinseng-specified reagents, otherwise the analyzer may be damaged or provide unreliable results.
- Pay attention to the expiration dates and open-container stability days of all the reagents. Be sure not to use expired reagents.
- Do not turn on/off the switch repeatedly in a short time to avoid damaging the analyzer.
- Do not reuse disposable products such as collection tubes, test tubes, capillary tubes and so on.
- Prepare samples following the recommend procedure of the manufacturer.
- All samples shall be mixed as shown in the following figure.
- Be sure to collect at least 0.5mL of blood to ensure the accuracy of the results.
- Be sure to collect at least 120uL of capillary whole blood to ensure the accuracy of the results.
- Do not start up the analyzer immediately after it is shut down. Wait for at least 10 seconds.
- Running QC sample with error present will lead to unreliable results. If errors are reported during QC analysis, remove the errors first and then continue with the analysis.
- Sample agglutination may result in inaccurate analysis results. Check the control samples to see if there is any agglutination, if yes, process the samples according to your laboratory's protocols.
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