Product Manual

MedSchenker® Disposable Culture Tube, February 17, 2021, STM-100-V-001-Q121
MedSchenker® Disposable Culture Tube in Pouch
Product Insert & How-to-Use Guide
INTENDED USE
MedSchenker® Disposable Culture Tube in pouch is ready-for-use tube intended for Bacteriology and other routine laboratory procedures. 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® Disposable Culture Tube. The Disposable Culture Tube is made from polypropylene and packed in a medical
grade paper pouch.
PRECAUTIONS
1. Carefully follow the instructions for use.
2. Product cannot be reused.
STORAGE
Store the MedSchenker® Disposable Culture 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® Disposable Culture 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 peel pouch and extract the tube.
2. Collect the sample.
3. Process the tube and sample according to internal laboratory procedure.
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® Disposable Culture 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 re-use Disposable Culture 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 if the Disposable Culture Tube 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.