berlinger BEREG-Kit small single User manual

USER MANUAL
BEREG-Kit
small single
Blood Sample
Container
Berlinger Special AG
Mitteldorfstrasse 2
9608 Ganterschwil
Switzerland
Tel. [phone]
[e-mail]
www.berlinger.com

ENGLISH
USER MANUAL BEREG-Kit small single Blood Sample Container | MKT-80057-EN www.berlinger.com
WHAT IS INCLUDED
In this BEREG-Kit small single, you will find:
• One (1) blood sample container with lasered number.
• One (1) security cap, sealed with a shrink sleeve wrap.
• Small labels with number and barcode.
• Other accessories including: one (1) watertight plastic bag, with an absorbent pad, for the purpose of transportation
to the laboratory (in compliance with the IATA Dangerous Goods Regulations).
The BEREG-Kit small single is packed and sealed in a security plastic bag.
The BEREG-Kit small single is uniquely numbered, with the number shown on all its components: the security bag, the
container and its security cap and additional labels.
INTENDED USE
BEREG-Kit small single is intended to be used to store and transport blood samples for the purpose of anti-doping and
drugs of abuse testing according to WADA ISTI requirements.
This kit is not a Medical Device (MD) and therefore is not intended to be used in a medical setting nor on the order of a
health care professional. This kit is also not indicated for or in assistance of disease screening or diagnosis.
Please note: The manufacturer does in particular not assume any liability for the application of incomplete or defective
kits or any unlawful actions during the entire doping control procedure nor if the sample is placed in other containers
or bags.
TABLE OF CONTENTS
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HANDLING INSTRUCTION
PREPARATION
Please check if the kit packaging is properly sealed or
shows any signs of manipulation:
• The security plastic bag is intact before opening it.
• The content of the BEREG-Kit small single is complete.
• The shrink sleeve wrap of the sample container is still
intact before removing it.
Please check if all components of the BEREG-Kit small
single have the same unique number on:
1. The security plastic bag (packaging)
2. The plastic sample container
3. The security cap
4. The additional labels
SECURITY CAP
Make sure that all elements of the cap are in place:
1. The white plug
2. The spring clip
3. The metal locking ring
RED RING
Please note: Remove the red ring before closure!
HANDLING STANDARDS AND REGULATIONS
This product should be used in accordance with the current
International Standard for the Protection of Privacy and Personal
Information (ISPPPI) and International Standard for Testing and
Investigation (ISTI) established by the World Anti-Doping Agency
(WADA).
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USER MANUAL BEREG-Kit small single Blood Sample Container | MKT-80057-EN www.berlinger.com

HANDLING INSTRUCTION
HANDLING THE BEREGKIT SMALL SINGLE
Please do the following:
• Insert the blood tube into the container according to regulations
• Close the container by gently pressing its cap down on it while
turning the cap at the same time in a clockwise direction. This
turning should produce a few audible clicks, and should be
continued until the cap can be turned no further.
CAUTION: Please turn gently and do not use too much force!
INSPECT THE CLOSED CONTAINER
Please do the following:
1. Try to lift the cap off, to ensure that it cannot be removed.
2. Try to turn the cap counterclockwise, to ensure that the cap is
securely closed.
According to individual guidelines, the BCO / DCO will repeat
the same actions, to double-check that the container is fully and
securely closed.
PREPARATION FOR TRANSPORTATION TO THE
LABORATORY
• To comply with the IATA DGR packaging regulations for the
transportation of „exempt human specimens“, the kit contains
one watertight plastic bag with an absorbent pad in the bag.
• The sealed container must be put into the watertight plastic bag
(leaving the absorbent pad inside the bag).
• The bag must then be sealed by removing the backing paper from
the adhesive tape and pressing this firmly together. Please also
ensure that this action leaves as little air as possible in the bag,
by stroking the bag upwards before closing it.
• After this procedure, please put the sealed container in an
appropriate bag or box to send it to the laboratory.
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ENGLISH
USER MANUAL BEREG-Kit small single Blood Sample Container | MKT-80057-EN www.berlinger.com

ENGLISH
USER MANUAL BEREG-Kit small single Blood Sample Container | MKT-80057-EN www.berlinger.com
WARNINGS AND PRECAUTIONS
• After sealing the sample, this product requires the handling of human specimens. It is
recommended that all human sourced materials be considered potentially infectious and handled
with appropriate biosafety practices.
• Please ensure that all national and international regulations are being complied with when
shipping the samples.
• Do not use the product if the package is damaged or the seal is broken.
• Discard unused, damaged, or leaking kits in accordance with local, state, and federal regulations.
• Do not use incomplete or defective kits or if package is damaged.
• Do not use the product beyond its expiration date (use-by).
• The items included in the BEREG-Kit small single are not provided sterile.
• Storage conditions of the kit before use: between 0°C and + 40°C.
• Maintain proper storage conditions during specimen shipping to ensure the integrity of the
specimen. Specimen stability under shipping conditions other than those recommended in WADA
ISTI has not been evaluated.
• Long-term storage conditions of containers according to WADA ISTI (6.3.4 e) & f)): the equipment
must be suitable for long-term storage in a frozen state, i.e. -80°C. Of the contents of an entire
BEREG-Kit small single, only the blood collection container that has been properly filled and sealed
within the expiry date meet these requirements.
• The items included in the BEREG-Kit small single are single-use items.
• Do not re-use any item.
• Optimal testing performance requires adequate specimen collection and handling. Ensure the
outside of the transport packaging and collection cups are not contaminated.
• Take care to avoid cross-contamination during the specimen handling steps. Specimens can
contain pathogens. Ensure that containers do not contact one another, and discard used materials
without passing over the containers. If gloves come into contact with specimen, change gloves to
avoid cross-contamination.
• All product tests have been performed with blood tube products (list up on request) from the
manufacturer BD (Becton Dickinson; www.bd.com).
ADDITIONAL HELPFUL MATERIALS
For more information on the product, consult the following resources:
The latest version of the user manual can be found on our
website
www.berlinger.com/handling-instructions
For additional information, check out the product webpage www.berlinger.com/bereg-kit-small
For more information, including ways to contact Berlinger,
check out our website
www.berlinger.com