Product Manual

Pull the swab midway up the tube so that the tip is parallel to the alternating hash marks. Squeeze the tube around the tip to remove any excess reagent, then pull the
swab out and discard.
MedSchenker® Smart Extraction Tube
Product Insert & How-to-Use Guide
INTENDED USE
MedSchenker® Smart Extraction Tube is used to apply a single droplet or more onto a lateral flow test cartridge for point of care rapid testing.
PRINCIPLES
One of the routine procedures in the diagnosis of infections involves the collection and testing of swab samples.
This can be accomplished using the MedSchenker® Smart Extraction Tube. The Smart Extraction Tube is made from
soft squeezable PVC plastic and packed in a
plastic bag.
PRECAUTIONS
1. Carefully follow the instructions for use.
2. Product cannot be reused.
STORAGE
Store the MedSchenker® Smart Extraction Tube at 2 - 25°C. If the product is stored at a different temperature, it would not maintain the stated specifications.
PRODUCT DETERIORATION
The MedSchenker® Smart Extraction Tube should not be used if (1) there is evidence of damage or contamination to the product, (2) the expiration date has passed, (3)
the package is open or damaged, or (4) there are other signs of deterioration.
DIRECTIONS FOR USE, SPECIMEN COLLECTION
NOTE: Sterile gloves, protective clothing and eyewear should be worn when collecting and handling microbiology specimens
1. Open the plastic bag and extract the tube.
2. Fill the tube with your desired reagent in the appropriate amount required for the specific test being conducted.
3. Collect the sample.
4. Place the sample in the extraction tube, squeezing the bottom to ensure the entire tip of the swab is immersed within the reagent to elute the most amount of
specimen.
5.
6. Close the connected cap and apply the appropriate number of droplets required onto the lateral flow test cartridge.
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.
LIMITATIONS
1. 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.
2. Condition, timing and volume of specimen collected for clinical investigation are significant variables in obtaining reliable results. Follow recommended guidelines
for specimen collection.
3. MedSchenker® Smart Extraction Tube must be used by skilled personnel only.
WARNINGS
1. This product is for single use only; reuse may cause a risk of infection and/or inaccurate results.
2. Do not reuse the Smart Extraction Tube.
3. Do not re-pack.
4. Not suitable for any other application than intended use.
5. The use of this product in association with a rapid diagnostic kit or with diagnostic instrumentation should be previously validated by the
user.
6. Do not use the Smart Extraction Tube if it is visibly damaged.
7. Directions for use must be followed carefully. The manufacturer cannot be held responsible for any unauthorized or unqualified use of the
product.
8. To be handled by trained personnel only.
9. 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.
WASTE DISPOSAL
Unused tubes may be considered as nonhazardous waste and disposed of accordingly. Dispose of used tubes 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 the
m (or have them treated and disposed of) in accordance with applicable regulations.