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A CAUTION is a statement that alerts to the possibility of a problem with the device
associated with its use or misuse. Such problems include device malfunction, device
failure, damage to the device or damage to other property.
2.1.1 Warnings
Before cleaning, always take out the load.
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These devices must only be used by adults. Do not allow children to play with the device.
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Do not store flammable or explosive substances inside these appliances (e.g. aerosols with
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flammable propellant). These may cause explosion or fire.
Only genuine spare parts may be used. Use of any other parts may affect the performance or
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cause physical injury or damage to the equipment.
The loading must never exceed the maximum load.
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Preparation of the cooling elements should be done by authorized personnel.
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Ensure that the transport boxes are adequately loaded with the correct amount of
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preconditioned cooling elements and maximum allowed storage load.
Make sure that no sharp or pointed objects come into contact with the cooling elements.
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Avoid long lid openings to prevent that the inner temperature rises to high.
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Make sure that the lid closes correctly and that the lid gasket seals correctly against the
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container.
Prior to using a transport box for the first time, the user should carry out his own tests and
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define a validation process under relevant conditions with the available equipment. We
recommend employing worst case scenario testing conditions. The cooling elements provide a
highly stable and well-designed system component, which, however, must be adapted to the
specific requirements of the user.
For the assessment and documentation of the product temperature over the transport period,
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the use of a temperature logging device is highly recommended. B Medical Systems will not be
liable for products stored out of specification, which are further processed or administered
after the transport.
PCM Packs must be carefully preconditioned for the specified temperature prior to each use.
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PCM Packs must never be opened.
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PCM Packs must be disposed of immediately if any coolant leaks, due to improper handling or
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a defect. Any products that have come into contact with leaked coolant must also be disposed
of immediately.
Damaged PCM packs should be disposed of in accordance with local regulatory requirements.
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The device and PCM packs should be disposed of in accordance with local regulatory
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requirements.
PCM Packs must be stored out of reach of children.
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Do not touch, inhale or ingest any escaping fluids.
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Before scrapping an old unit, remove the lid so that nothing essential is forgotten inside the
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device.
Follow the local prescriptions on disposal of hazardous equipment.
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2.1.2 Cautions
Check whether the appliance has been delivered undamaged. If you find that damage has
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occurred in 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
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outlet and ask them.
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2. Important Information
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