Product manual and use guide
Product name: Disposable sampling swab
Product performance structure and composition:
The swab is a plastic rod artificial fiber swab. The product consists of: swab (artificial fiber), polystyrene plastic rod, in two kinds of packaging: paper-plastic and tube, single-use: gamma irradiation sterilization.
Product scope of use (intended use and indications)
Disposable sampling swabs (hereinafter referred to as swabs) are used in medical clinics for the collection of samples for bacteriological examination. The swab is suitable for short-term contact with the human body, and the product is used according to the regulations.
Contraindications: None
Technical description
Slight yellowing of the swab head is a known phenomenon and may be due to a number of factors, including the type of raw material, the sterilization process of the product, and the natural aging of the product. Therefore, yellowing of the product does not mean deterioration of the product.
Precautions
1. Observe the instructions for use.
2. When using instruments with plastic or wooden rods, the pressure applied during sampling should be low because the rod material is fragile.
3. The adhesion of fibers to the rod is tested by instantaneous sampling, and the longer the contact time between the swab and the sampling area, the longer the fibers may fall off.
4. If a chemical or physical sterilization or sterilization process is performed on the swab, it may impair its intended function.
5. The product should not be reused or re-sterilized.
Storage and Transport
Store swabs at 2-30°C. If the product is stored at other temperatures, the established specifications will not be maintained.
Product deterioration
Sterility can be guaranteed for products whose packaging has not been opened or damaged.
If there is
(1) evidence of damage or contamination of the product.
(2) The expiration date is exceeded.
(3) Swab packaging is open or bad.
(4) There are other signs of deterioration, the swab should not be used.
Instructions for use, sample collection
If the swab is packaged in a paper bag, instructions for use and illustrations are also printed on each bag.
Caution: Wear sterile gloves, HU-proof clothing and protective goggles when collecting and handling microbiological samples
1. Open the bag and remove the swab
2. Collect the sample. During sampling, the swab head should only be at the suspected site of infection to minimize the risk of contamination.
Caution: When collecting swab samples from patients, do not apply excessive force, tighten or bend the swab as this may result in accidental damage to the rod. Rods typically have different diameters to support different sampling requirements. The rod may also have a previously made break in it. The swab is intentionally broken so that it can be placed in the transfer cannula. Under no circumstances should excessive force, pressure or bending of the swab be used when collecting swab samples from patients, as this may result in accidental damage to the rod section.
3. Handle the swab according to internal laboratory procedures or place the swab in the transfer sleeve.
4. Send the sample to the laboratory.
Samples collected for clinical studies should be collected and processed according to published instructions and guidelines.
Sample transport and handling requirements should be in full compliance with relevant national regulations. The transport of samples within a healthcare facility should be in accordance with the facility's internal regulations.
Restrictions on use
1. Wear protective gloves and take other comprehensive protective measures when handling clinical samples in the laboratory. Biosafety recommendations should be followed when handling or analyzing patient samples.
2. The condition, timing and volume of samples collected for clinical studies are important variables required to obtain reliable results. The requirements in the sample collection guidelines should be followed.
3. Swabs should only be used by skilled personnel.
WARNING
1. This product should only be used in a single application; repeated use may result in risk of infection or inaccurate results.
2. Do not re-sterilize unused swabs. 3.
3. Do not repackage. 4.
4. Not for use in any other application than the intended use. 5.
5. If this product is used in combination with a rapid diagnostic kit or diagnostic device, it should be confirmed by the user in advance.
6. Do not use if the swab is visibly damaged (e.g., swab* or broken swab stem).
7. Swab samples should not be taken from patients with excessive force or pressure, as this may cause the swabstick to break.
8. Instructions for use must be carefully followed and the manufacturer assumes no responsibility for any unauthorized or substandard use of the product.
9. should only be operated by trained personnel.
10. It must be assumed that all samples include infectious microorganisms and, therefore, all samples must be handled with proper precautions. After use, tubes and swabs must be disposed of in accordance with laboratory infectious waste regulations.
