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2.3 Unpacking and Inspection
CAUTION
Check whether the unit has been delivered undamaged. If you find that damage has occurred in
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transit, immediately contact the delivery service or relevant sales outlet, submitting the delivery note
or proof of purchase.
Do not operate a unit that has been damaged in transit! If you are unsure, contact your sales outlet
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and ask them.
Check whether the unit has been delivered with all necessary interior accessories. Refer to the
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specific transport box in Chapter 6: Technical Data.
Make your contribution to saving the environment. Bear in mind that orderly and proper
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disposal of packing materials is required. Packaging materials and devices are always
recyclable and should be taken for recycling.
2.4 Intended Use
2.4.1 Intended Purpose
Blood transport boxes are thermal insulated containers intended to be used in the blood
transfusion medicine for the support on the diagnosis, prevention and treatment of diseases
or injuries by maintaining preconditioned whole blood or blood components (e.g., blood cells,
platelets, or frozen plasma) at a protective and stable temperature during transport until they
are ready for use. The devices use frozen ice packs or PCMs (Phase Changing Materials) as
cooling elements.
2.4.2 Intended Target Users
Pharmacists, doctors, laboratory staff or other staff that are trained and/or experienced in
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dealing with whole blood and blood components.
The blood transport boxes must be operated by individuals in organizations that have the
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knowledge of applicable regulations and guidelines on the storage and distribution of blood
and blood components. The organization must implement and validate procedures for the
storage and distribution of blood and blood components according to these regulations and
guidelines, including the necessary storage temperature and the suitable storage period.
Service technicians with a recognized license or certificate as required by local authorities for
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installation, servicing and repair of refrigeration systems and equipment, and properly trained
on the blood transport boxes models.
Patients do not come into direct contact with the devices.
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2.4.3 Intended Use Environment
The blood transport boxes are non-stationary type devices and are intended to be used for the
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transport of blood components in- and outdoors.
The blood transport boxes are designed to operate at an ambient temperature between
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- 10°C and +43°C
Additional environmental requirements for a safe operation of the devices are documented in
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the operating instructions and must be observed.
The ambient temperature range during transport and storage must be -30°C to +70°C at a
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humidity level between 5% and 95%.
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2. Important Information
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