Operational Use; Device Classification - Covidien Puritan Bennett 540 User Manual

Ventilator Overview
2.3

Operational Use

The Puritan Bennett 540™ Ventilator uses a micro-turbine and the patient circuit with integral
exhalation valve to provide ventilatory support to patients. Clinicians may use a variety of interfaces
to connect patients to the ventilator: nasal or full face masks; endotracheal or tracheotomy tubes.
User-selectable ventilation modes are:
•
Assisted Controlled Volume (VOLUME A/C)
•
Assisted Controlled Pressure (PRESSURE A/C)
•
Synchronous Intermittent Mandatory Ventilation Volume (V SIMV)
•
Synchronous Intermittent Mandatory Ventilation Pressure (P SIMV)
•
Continuous Positive Airway Pressure (CPAP)
•
Pressure Support Ventilation (PSV)
Safety Net
Incorporated in the ventilator design is an alarm system that continuously monitors both patient and
machine for signs of specific errors or faults that could lead to an unsafe condition. Should any of
these errors or faults be detected, the alarm system announces the specific alarm condition both
audibly and visually. The machine-related alarm conditions are factory set, whereas the patient-
related alarm conditions are defined by alarm-threshold values selected by an operator (a clinician
or a caregiver). For more information, refer to chapter
Settings
A software key, known as the "Locking Key, " restricts access to ventilation parameter settings and
ventilation mode changes in order to distinguish between "clinician" usage and "patient" usage.
Oxygen Enrichment
Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be limited
to 15 lpm at 7.25 psi (50 kPa). The ventilator automatically compensates for the extra flow created by
the external oxygen supply
Breathing Circuit
The ventilator can be used with a single or double limb patient circuit. If exhaled volume monitoring is
required (such as ventilator dependant patients), use the double-limb circuit for exhaled tidal volume
or minutes volume monitoring. For more information, refer to section
6.
Note: It is highly recommended that users always possess an additional breathing circuit and valve while using
the Puritan Bennett 540™ Ventilator.
2.4

Device Classification

The ventilators IEC 60601-1classification is as follows:
•
Protection/Insulation class (electric shock): Class II
•
Protection index of enclosure: IP31
•
Medical device directive classification: II B
•
Degree of protection against risk of electric shock: BF
•
Power: External (AC – mains, or DC – cigarette lighter) or internal (DC – battery)
•
Operation mode: Continuous operation
2-2
( refer to chapter 4, "Installation and Assembly. "
3, "Alarms and Troubleshooting. "
)
4.4, "Patient Circuit, " on page 4-
Puritan Bennett 540™ Ventilator User's Manual