Indications For Use; Functional Safety - Dräger Infinity Acute Care System M540 Instructions For Use Manual

Indications for use

The M540 is capable of monitoring the following pa-
rameters:
– Heart rate
– Arrhythmia (adult and pediatric patients only)
– 12-lead ECG monitoring
– TruST monitoring (adult and pediatric patients
only)
– ST segment analysis (adult and pediatric pa-
tients only)
– 12-lead ST segment analysis (adult and pediat-
ric only)
– Apnea
– Respiration rate – RRi
– Invasive blood pressure – IBP
– Non-invasive blood pressure – NIBP

Functional safety

The essential performance of a patient monitor is to
provide a clinician with meaningful parameter val-
ues and alarm annunciation when the established
parameter limits have been exceeded or the ability
to provide values is compromised. Risks associat-
ed with use of the monitor in light of these essential
performance functions have been evaluated and
mitigations implemented so that the residual risk is
as low as reasonably practicable, provided routine
maintenance and service recommendations are fol-
lowed throughout the life of the product.
Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
– Temperature
– Cardiac output – only available when the M540
is docked in an IACS configuration (adult and
pediatric patients only)
– Arterial oxygen saturation – SpO
– Pulse rate
– Mainstream etCO
2
– Perfusion index – PI
– Total hemoglobin – SpHb, (adult and pediatric
patients only)
– Total oxygen content – SpOC, (adult and pedi-
atric patients only)
– Carboxyhemoglobin saturation – SpCO
– Methemoglobin saturation – SpMet
– Pleth variability index – PVI
Application
2
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