Mid-turbinate - Anterior Nares Swabs for Children and babies
Recommended for use in Children & pediatric populations, the Mid-turbinate CavSwab™ with Allium™ flock technology has been marked for uncomplicated identification of required depth and a removable stopper indicates when that depth has been reached.
|Inner Box||100 units (Blue or Pink)|
|Shelf life||36 months|
|Nylon tip||Allium™ flock technology|
|Intended use||Sample collection|
|Made in||South Korea|
MedSchenker® CavSwab™ Mid-turbinate in Pouch
Product Insert & How-to-Use Guide
MedSchenker® CavSwab™ Mid-turbinate in pouch is a sterile and ready-for-use system intended for clinical samples drawing. The CavSwab™ is suitable for short contact with the human body. Product should be used as directed.
SUMMARY AND PRINCIPLES
One of the routine procedures in the diagnosis of infections involves the collection of swab samples. This can be accomplished using the MedSchenker® CavSwab™. CavSwabs are available with different size and shape shaft and tip for the two types of body collection sites. CavSwabs are made from nylon and are packed into a medical grade paper pouch. CavSwabs are electron beam sterilized. The sterilization type is indicated on the product labels (pouch, carton and/or box labels.)
A slight yellowing of the tip is a well-known phenomenon. This could be due to many factors: the type of raw material, the product sterilization treatment or the products natural aging. Therefore, product yellowing is not necessarily indicative of product deterioration.
- Carefully follow the instructions for use.
- When using a device with a plastic or wooden stick, the pressure applied during sampling shall be light since the stick material is breakable
- The fiber adhesion to the stick is tested for instantaneous sampling: longer contact between the swab and the sampling area might cause the fibers to come out.
- If the swab is submitted to a chemical or physical sterilizing or micro-biostatic process, its intended functioning could be compromised.
- Product cannot be reused or re-sterilized.
Store the MedSchenker® CavSwab™ device at 2 – 25°C. If the product is stored at a different temperature, it would not maintain the stated specifications.
The contents of the unopened and undamaged units are guaranteed to be sterile. MedSchenker® CavSwabs should not be used if (1) there is evidence of damage or contamination to the product, (2) the expiration date has passed, (3) the swab package is open or damaged, or (4) there are other signs of deterioration.
DIRECTIONS FOR USE, SPECIMEN COLLECTION
NOTE: Sterile gloves and protective clothing and eyewear should be worn when collecting and handling microbiology specimens
- Open the peel pouch and extract the swab.
- Determine the age of the child and snap on the bear clip(to the appropriate notch) to ensure that the swab is not inserted too deep
- Collect the sample. During sampling, the swab end (tip) shall only come in contact with the suspected infection, so as to reduce contamination risks.
- Process the swab according to internal laboratory procedure. Alternatively put the swab in the transport test tube.
- Send the sample to the laboratory for immediate testing.
Specimens collected for clinical investigations should be collected and handled following published manuals and guidelines. Specific requirements for the shipment and handling of specimens should be in full compliance with state and federal regulations. Shipping of specimens within medical institutions should comply with internal guidelines of the institution.
- In the laboratory, wear protective gloves and other protection commensurate with universal precautions when handling clinical specimens. Observe Biosafety recommendations when handling or analyzing patient samples.
- Condition, timing, and volume of specimen collected for clinical investigation are significant variables in obtaining reliable results. Follow recommended guidelines for specimen collection.
- MedSchenker® CavSwabs must be used by skilled personnel only.
- This product is for single use only; reuse may cause a risk of infection and/or inaccurate results.
- Do not re-sterilize unused swabs
- Do not re-pack
- Not suitable for any other application than intended use.
- The use of this product in association with a rapid diagnostic kit or with diagnostic instrumentation should be previously validated by the user.
- Do not use if the swab is visibly damaged (i.e., if the swab tip or swab shaft is broken).
- Do not use excessive force, pressure or bending when collecting swab samples from patients as this may result in accidental breakage of the swab shaft.
- Directions for use must be followed carefully. The manufacturer cannot be held responsible for any unauthorized or unqualified use of the product.
- To be handled by trained personnel only.
- It must be assumed that all specimens contain infectious micro-organisms; therefore, all specimens must be handled with appropriate precautions. After use, tubes and swabs must be disposed of according to laboratory regulations for infectious waste.
Unused swabs may be considered as nonhazardous waste and disposed of accordingly. Dispose of used swabs as well as any other contaminated disposable materials following procedures for infectious or potentially infectious products. It is the responsibility of each laboratory to handle waste and effluents produced according to their nature and degree of hazardousness and to treat and dispose of them (or have them treated and disposed of) in accordance with applicable regulations.