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Taking samples of clinical material to identify aerobic, anaerobic and fastidious bacteria, viruses and chlamydia.
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Add to wishlistTaking samples of clinical material to identify aerobic, anaerobic and fastidious bacteria, viruses and chlamydia.
The product is intended for use STRICTLY for its intended purpose.
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Taking samples of clinical material to identify aerobic, anaerobic and fastidious bacteria, viruses and chlamydia.
The product is intended for use STRICTLY for its intended purpose.
If the tampon is in a Peel Pouch package, the user’s instructions can be found on each Kopan Flock Technologies package, along with a visual drawing.
NOTE: When collecting and processing microbiological samples, wear sterile gloves, protective clothing, and safety glasses.
1. Open the bag and remove the swab.
2. Collect the sample. When taking a sample, you should gently touch the tip of the tampon to the site of the suspected infection to reduce the risk of contamination.
NOTE: When taking a sample of the patient, do not apply excessive force, do not press on the swab or bend the applicator, as it may break accidentally. Applicator handles often come in different diameters to meet different sampling requirements. There may also be a break point on the applicator handle, designed for special breaking off of the handle holder when placing the swab in a test tube for transportation. In any case, when taking the patient’s material, do not apply excessive force, do not press on the tampon or bend it, as it may accidentally break.
3. Treat the tampon according to the internal laboratory regulations. Alternatively, place the swab in a test tube for transport.
4. Send the sample to the lab for an urgent test. Samples intended for clinical trials should be collected and processed in accordance with published guidelines and guidelines.
Special requirements for sending and processing samples must fully comply with state and federal regulations. Sending samples inside a medical facility must comply with the internal instructions of that facility.
Velour tampons FLOQSwabs â„¢ and traditional CLASSIQSwabsâ„¢tampons in packaging are sterile and ready-to-use systems designed for collecting clinical samples. A tampon is a product that comes into short-term contact with the human body.
The standard procedure for diagnosing infections involves taking clinical samples. You can perform this process using velour tampons or traditional Copan tampons. Copan tampons are available in different sizes, with different types of applicators to take samples from different loci.
Different tampon materials are available depending on the test method and sample type: viscose, polyester, cotton for the CLASSIQSwabs range, and nylon for the FLOQSwabsâ„¢range. FLOQSwabsâ„¢ are also supplied in a labeled polypropylene tube. A special product line called FLOQSWABS â„¢ is available, which is guaranteed to be free of human DNA, DNASE, and RNASE. Copan tampons are delivered in a Wheel Pouch package. They are sterilized by gamma radiation or ethylene oxide. The method of sterilization is indicated on the product label (marking on packaging, cardboard packaging and / or box).
POTENTIAL CONSUMER
Medical devices are intended for use in specialized medical institutions by appropriately qualified personnel.
TECHNICAL NOTES
Light yellowing of the applicator can be caused by many factors: the type of raw material, product sterilization, natural aging of the product. Therefore, such yellowing does not necessarily indicate a deterioration in the quality of the product.
SPECIAL INSTRUCTIONS
1. Follow the instructions for use exactly.
2. When using a system with a plastic or wooden applicator, do not apply excessive pressure when taking samples, so as not to break it.
3. The adhesion strength of the tampon and applicator was checked for instant sampling. Prolonged contact between the swab and the sample area may cause the fiber to escape.
4. If the tampon is subjected to chemical or physical sterilization or microbiostatic treatment, it may not function properly.
5. The product must not be reused or re-sterilized.
PRODUCT DAMAGE
The contents of unopened and undamaged packages are guaranteed to be sterile. Copan tampons should not be used if (1) there are signs of damage or contamination to the product, (2) the expiration date has expired, (3) the tampon packaging is opened or damaged, or (4) there are other signs of damage.
RESTRICTIONS
1. When in the laboratory, wear protective gloves and other protective equipment that comply with general precautions for handling clinical samples. Follow the biosafety guidelines when handling or analyzing patient samples.
2. The conditions, time, and volume of the sample collected for the clinical trial are significant for obtaining reliable results. Follow the best practices for collecting samples.
3. Copan tampons should only be used by qualified personnel.
WARNINGS
1. This product is intended for single use only; repeated use may cause the risk of infection and/or inaccurate results.
2. Unused tampons should not be re-sterilized.
3. Not recyclable.
4. It is not intended to be used for any other purpose.
5. The use of this product in combination with a rapid diagnostic kit or diagnostic equipment must be pre-validated by the user.
6. Do not use if there are visible signs of damage to the tampon (i. e., if the applicator or handle of the tampon is broken).
7. When taking a swab from a patient, do not apply excessive force, do not press on the swab or bend the applicator, as it may accidentally break.
8. It is necessary to follow the instructions for use exactly. The manufacturer is not responsible for any improper or inappropriate use of the product.
9. For use only by trained personnel.
10. Please note that any sample may contain infectious micro-organisms, so all samples should be treated with appropriate precautions. After use, test tubes and swabs should be disposed of in accordance with laboratory instructions for contaminated waste.
WASTE MANAGEMENT
The used medical device and its packaging are Class B medical waste. Medical waste must be disposed of in accordance with the requirements of SanPiN 2.1.7.2790-10. Class B medical waste is epidemiologically hazardous medical waste (potentially infected or contaminated). Failure to comply with the rules and regulations for the disposal of medical waste may result in the risk of infection of medical personnel and patients, as well as environmental pollution.
Copan tampons should be stored at a temperature of 2 to 30°C. If the product is stored at a different temperature, it will not meet the stated specifications.
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