berlinger BEREG-Kit small User manual

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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
USER MANUAL
BEREG-Kit small
Blood Sample
Container
Article#: 920-00001
Berlinger Special AG
Mitteldorfstrasse 2
9608 Ganterschwil
Switzerland
Tel. [phone]
[e-mail]
www.berlinger.com

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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
WHAT IS INCLUDED
In this BEREG-Kit small Blood Sample Container kit, you will find:
• Two (2) blood sample containers:
• 1x A-container with lasered number
• 1x B-container with lasered number
each container with its own security cap and each sealed with a shrink sleeve wrap.
• Eight (8) small labels with number and barcode
• Other accessories including: two (2) watertight plastic bags, each with an absorbent pad, for the purpose of
transportation to the laboratory (in compliance with the IATA Dangerous Goods Regulations)
Each BEREG-Kit small is packed and sealed in a security plastic bag.
Each BEREG-Kit small is uniquely numbered, with the number shown on all its components: the security bag, the
containers and their security caps.
INTENDED USE
BEREG-Kit small Blood Sample Container is intended to be used to store and transport blood samples for the purpose
of anti-doping and drugs of abuse testing outside of a medical setting and not on order of a health care professional.
This kit is not intended to be used for or in assistance of disease screening or diagnosis. This kit is intended to be used
in accordance with the current international standard on testing and investigations established by the World Anti-
doping Agency (WADA) ISTI 2019.
LIMITATIONS OF THE PRODUCT
• Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage.
• This product is not intended to be used for or in assistance of disease screening or diagnosis.
TABLE OF CONTENTS
   
  
    
  
    
   
   

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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
HANDLING INSTRUCTION
PREPARATION
• Please make sure that the BEREG-Kit small is intact and
that the pre-sealing of the security plastic bag and the
shrink sleeve wrap of the containers are still intact.
• Please check if all components of the BEREG-Kit small
have the same unique number on:
1. The containers
2. The security caps
3. The security plastic bag and labels
SECURITY CAP
Make sure that all the caps’ elements are in place:
1. The white stopper
2. The grey spring clip
3. The grey metal ring
RED RING
Please note: Remove the red ring before closure!
HANDLING THE BEREGKIT SMALL
The BCO is to proceed with the blood collection procedures as
outlined by the guidelines for blood sample collection (WADA
guidelines). As soon as the blood samples are ready, place one sample
into the A-container and the other sample into the B-container.
Under direction and supervision of the BCO, the athlete must:
• Double check that all the numbers on all components are identical.
• Remove the red rings (which prevent the accidental closure of the
containers).
• Insert the blood tube into the A- and B-containers as directed.
• Close each 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!
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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
HANDLING INSTRUCTION  CONTINUED
INSTRUCTING THE ATHLETE
The BCO shall instruct the athlete to do the following:
1. Try to lift the cap off, to ensure that it cannot be removed.
2. Try to turn the cap anticlockwise, to ensure that the cap is
securely closed.
According to individual guidelines, the BCO will repeat the same
actions, to double-check that both containers are 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 BEREG-KIT small
contains two watertight plastic bags with an absorbent pad in
each bag.
• Each sealed container must be put into one of these watertight
plastic bags (leaving the absorbent pad inside the bag).
• Each bag must then be sealed by removing the backing paper from
the void 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.
• Include all relevant paper work.
• After this procedure please put the sealed containers in an
appropriate bag or box to send it to the laboratory. „Biological
Risk“ symbols needs to be placed on shipping container prior to
shipment.
• The blood samples shall be transported in a refrigerated state.
Please follow the prescribed temperatures and conditions as
outlined in the guidelines for blood sample collection (WADA
guidelines).
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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
WARNINGS AND PRECAUTIONS
• CAUTION: 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. Only personnel adequately trained in handling infectious materials should be permitted
to handle specimens.
• To ship blood sample, place the “Biological Risk” symbol on shipping container
• CAUTION: 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.
• CAUTION: Do not use incomplete or defective kits.
• CAUTION: Do not use the product beyond its expiration date (use-by).
• The items included in the Berlinger BEREG-Kit small are not provided sterile.
• Storage conditions: between - 80°C and + 40°C, according to WADA ISTI 2019, see Berlinger Declaration
of Conformity, www.berlinger.com/declaration_of_conformity.
• Maintain proper storage conditions during specimen shipping to ensure the integrity of the specimen.
• The items included in the Berlinger BEREG-Kit small 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 caps are not contaminated.
• Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain
high level of 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.
• If the contents are spilled at any time during the collection procedure, use a new collection kit. Failure
to use a new kit may invalidate the test results.
• All product tests have been performed with blood tube products (list up on request) from the
manufacturer BD (Becton Dickinson; www.bd.com). For all other tubes for blood collection please
perform your own tests.
ADDITIONAL HELPFUL MATERIALS
For more information on the BEREG-Kit small, consult the following resources:
The latest version of the user manual / handling instructions can
be found on our website
www.berlinger.com/handling-instructions
For additional information, check out the BEREG-Kit small
produt webpage
www.berlinger.com/bereg-kit-small
For more information, including ways to contact Berlinger, check
out our website
www.berlinger.com
700-00050_1

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USER MANUAL BEREG-Kit small Blood Sample Container www.berlinger.com
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