700-01086 2 user manual bereg-kit small single blood

of 6USER MANUAL BEREG-Kit small single Blood Sample Container www.berlinger.com

USER MANUAL

BEREG-Kit small singleBlood Sample Container

Berlinger Special AGMitteldorfstrasse 2

9608 Ganterschwil

Switzerland

Tel. +41 71 982 88 11

[email protected]

www.berlinger.com

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WHAT IS INCLUDED

In this BEREG-Kit small single Blood Sample Container kit, you will find:

• One (1) blood sample container:

• 1x container with lasered number A container with its own security cap and 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).

Each BEREG-Kit small single is packed and sealed in a security plastic bag.

Each BEREG-Kit small single is uniquely numbered, with the number shown on all its components: the security bag, the container and the security cap.

INTENDED USE

BEREG-Kit small single 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.

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

What IS Included 2Intended uSe 2lIMItatIOnS OF the PROduct 2handlInG InStRuctIOn 3handlInG InStRuctIOn - cOntInued 4WaRnInGS and PRecautIOnS 5addItIOnal helPFul MateRIalS 5

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HANDLING INSTRUCTIONPREPARATION

• Please make sure that the BEREG-Kit small single is intact and that the pre-sealing of the security plastic bag and the shrink sleeve wrap of the container are still intact.

• Please check if all components of the BEREG-Kit small single have the same unique number on:

1. The container

2. The security cap

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 SINGLE

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 sample is ready, place the sample into the 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 ring (which prevent the accidental closure of the containers).

• Insert the blood tube into the container as directed.

• 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!

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HANDLING INSTRUCTION - CONTINUEDINSTRUCTING 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 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 BEREG-KIT small single 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 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 sample 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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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 single are not provided sterile.

• Storage conditions: between - 80°C and + 40°C, according to WADA ISTI, 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 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 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 MATERIALSFor more information on the BEREG-Kit small single, 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 product webpage

www.berlinger.com/bereg-kit-small

For more information, including ways to contact Berlinger, check out our website

www.berlinger.com

700-01086_2

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700-01086 2 user manual bereg-kit small single blood

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