Getinge MAQUET BC 20 plus Gebrauchsanweisung Seite 9

5 Warnings and Precautions
5.1 Basic Safety Instructions
n Failure to comply with the intended use can result in serious injuries or death.
– Only use the device in accordance with these Instructions for Use.
– Read the Instructions for Use completely before using the device.
– Observe all information on the device.
– Also follow the Instructions for Use for additional components used.
n A lack of knowledge on use of the device can result in serious injuries to or death of the pa-
tient.
– The device may only be operated and monitored by qualified medical staff.
– The device may only be operated by staff specially trained in the field of extracorporeal
circulation.
– The physician in charge of treatment is responsible for the procedure and correct use of
the device.
n The use of non-sterile or defective devices can result in infection of the patient, user and
third parties.
– Only use the device if it is sterile.
– Do not use the device if it or the sterile packaging is damaged.
– Observe the use-by date on the packaging.
– Always observe strict asepsis when handling the device.
n Modifications to the device can result in serious injuries to or death of the patient.
– Do not modify the device.
n Resterilization can damage the device. This can lead to inadequate patient support and in-
fection of the patient, user and third parties.
– Do not resterilize the device.
– Do not use resterilized devices.
n Missing protective caps can result in the device becoming soiled. This can lead to infections
in the patient.
– Immediately after opening the sterile packaging, check that all blood-carrying connec-
tors are protected by protective caps.
– Do not use the device unless all blood-carrying connectors are protected by protective
caps.
– Only remove the protective caps immediately before use.
n The materials used can trigger allergic reactions.
– Explain the possible consequences to patients before use.
– The physician must provide suitable drug treatment if an allergic reaction occurs.
– In severe cases the treatment must be stopped.
n
Contact with solvents such as alcohol, ether, acetone, and liquid inhalation anesthetics (e.g.
isoflurane, Ethrane, enflurane) can damage the device. Its functionality is no longer guaran-
teed and the manufacturer will not accept liability under any circumstances.
– Do not allow solvents to come into contact with the interior or exterior of the device.
5.2 Safety Instructions for the Extracorporeal Circulation
n Implementing an extracorporeal circulation can cause the associated side effects in the pa-
tient, such as infections, hemolysis, embolisms, post-perfusion syndrome and organ dam-
age.
– Monitor the patient regularly for possible side effects.
n No anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal
circulation and the patient circuit. This can lead to inadequate patient support, hemolysis or
thrombus formation in the patient.
– Weigh up the benefits of extracorporeal circulation against the risk of systemic antico-
agulation.
| BC 20 plus / BC 60 plus / BC 140 plus | 9 |
Instructions for Use | 2.7 | G-153 | 07
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