Users Manual

Technical Data
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Essential performance: The function of this device is to maintain pressure in the cavity at
the nominal pressure.
(Limits, fully functional: 1 to 30mmHg)
Limit, total loss of the identified performance (Normal Condition):
Pressure of >45mmHg can cause injury to patient and is identi-
fied as unacceptable risk.
Pressure of < 0 mmHg in abdomen can cause injury to patient
(due to instruments perforating tissue) and is identified as unac-
ceptable risk.
Limit, total loss of the identified performance (Single fault condi-
tion):
Pressure of >80mmHg can cause injury to patient and is identi-
fied as unacceptable risk.
Pressure <-112.5mmHg in abdomen can cause injury to patient
(due to instruments perforating tissue) and is identified as unac-
ceptable risk.
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DRAFT