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STERILE CONTAINERS FOR SAMPLE COLLECTION WITH INTEGRATED TRANSFER DEVICE

For collection, storage, and transportation of human biological fluids (urine) for subsequent examination.
Read product’s instructions for use carefully before use. Single use. Sterile.
Product not made with natural rubber latex or dry natural rubber.
Medical device for In Vitro Diagnostic.

Instructions for transport of urine specimens:

Intended use: 1. For transport of container to the laboratory, provide adequate warning using labelling
Sterile collection container with an integrated transfer device designed for the collection, and packaging to protect against inadvertent needlesticks caused by sharp located under
storage and transport of urine specimens. The product is intended to be used for the pa- label. Carefully replace label over integrated transfer device cavity. Treat the screw cap of
tient to collect the urine according to the instructions for previous preparation and sample the specimen container as a contaminated sharp. All collection devices, both containing
collection indicated by the health personnel or laboratory. Urine may be transferred via the sample or used, should be classified as biohazardous for handling and disposal purposes.
integrated transfer device into an evacuated tube for transport and storage. It is responsibility of each laboratory to handle, treat and dispose of waste according to
current legislation. Non-used containers may be considered non-hazardous and may be
General precaution: disposed of according to these criteria.
• Be careful when handling the lid of the container which is containing a needle under the 2. Properly label tubes with patient name, i.d., collection date and time and any additional
label. Risk of puncture. information required by your facility’s policy.
• Not suitable for any application other than its intended use. 3. Properly label and package any container used to transport specimen to alternate loca-
• Do not squeeze or press the container. tion in accordance with applicable local, State and federal requirements.
• Do not use if package is damaged as this could compromise the sterilization of the product.
• Do not use if, when removing the label from the lid, the needle that forms the transfer Instructions for sample processing:
system for sample extraction is broken or bent. 1. Follow standard precautions when testing the sample: wear gloves, lab coat, eye protec-
• Do not re-use. The re-use of this product may affect the subsequent analysis of the sample taken. tion or other personal protective equipment to protect against potential sample splashes,
• Keep away from sunlight. leaks, or possible exposure to pathogens.
• Do not use if printed product information is not displayed correctly. 2. Place the container upright on a flat and clean Surface. The container may be tilted if the
• Do not use if the expiry date is exceeded. volume of the sample is small.
• Discard the product if it is dirty. 3. Remove the label from the lid in order to reach the integrated transfer system of the
container.
Special precautions: 4. Place the vacuum tube with the cap facing down into the lid cavity.
Healthcare professionals must validate the use of the container for their specific assay- 5. Advance the tube over the puncture point to introduce the needle of the transfer system
instrument/reagent system combinations and specimen storage conditions. into the tube’s cap.
6. Hold the tube in position until the tube is filled. Urine flows automatically inside the tube.
Instructions for the patient: 7. Remove the tube from the transfer system when full.
1. Wash your hands and then your genitals. Dry with paper tower. 8. Repeat steps 4-7 for filling additional vacuum tubes and once finished, place the label in
2. Do not to remove the label on the cap to protect against needle puncture from the the cap cavity to reseal the cap to prevent accidental needle puncture.
specimen transfer system. 9. Discard the containers for sample collection according to your center’s protocols for dis-
3. Check that the container is properly closed and that the safety closure, if it exists, has not card biohazardous residues.
been opened, as this could compromise the sterility of the product. To open the container,
turn the lid until you hear the safety lock breaking, if one exists.
Remove the lid from the container and place it upside down on a flat surface avoiding the
5
inner part of the lid to contact anything, preventing its contamination. 2 3 4 6 7
4. Collect the sample as per the Health Care Professional’s instructions, considering pre-
vious preparation as indicated.
5. Deposit the specimen directly into the container and put on the lid again on the contai-
ner to avoid contamination. References:
6. Return the container to the healthcare professional after collection. 1. Merritt AD, Sanford, JD. Sterile voided urine culture. J Lab Clin Med. 1958;52:463-470.
7. If you have a sample collection set or kit (which includes vacuum tube) and have been 2. Clinical Laboratory Standards Institute (CLSI), Urinalysis - Approved Guideline – Third
instructed by your healthcare professional to obtain the sample in the tube, follow the Edition, GP16-A3, Wayne, PA, 2009.
instructions for sample processing (from step 2). 3. Cabedo C, et al. ¿Es importante la técnica de recogida de la orina para evitar la contami-
nación de las muestras?. Aten Primaria 2004;33(3):140-4. 2003
5 5. Bárcenas P, et al. Evaluación de una mejora preanalítica en urianálisis. Rev Latinoam Patol
2 3 4 6 Clin Med Lab. 2017.
6. Topcuoglu C, et al. Comparison of vacuum and non-vacuum urine tubes for urinary sedi-
ment analysis. Scandinavian Journal of Clinical and Laboratory investigation, 77:8, 592-594.
2017

Symbol glossary:

Consult instructions for use

Catalogue number Batch number on the website www.deltalab.es/eifus
QTY Quantity
deltalab.es/eifus

IVD In vitro Diagnostic Unique device identifier Do not use if package is damaged Precaution

Keep away from sunlight Manufacturer Use-by-date CE marking

Sterile by irradiation Sterile by aseptic processing techniques Do not re-use

DELTALAB, S.L.
Plaza de La Verneda 1, Pol. Ind. La Llana,
08191 Rubí, Barcelona. España/Spain.
IVD
[email protected] - www.deltalab.es

UPDATING DATE: 2024/10 TEC 1594 Rev.1