Regulatory compliance
D-9
Applied parts The V60/V60 Plus Ventilator system includes these applied parts:
• Patient interfaces
• Tracheal and endotracheal tubes
• High flow therapy nasal cannula and interface
• Nebulizer T-adapter
• Ventilator breathing system - Type B (inspiratory or expiratory pathways
through which gas flows at respiratory pressures and bounded by the
ports through which gas enters and the patient-connection port),
which can also include the following:
- Humidifier chamber
- Patient circuits
Accessible parts The V60/V60 Plus Ventilator system includes these accessible parts:
• Filters
• Roll stand
• Humidifier
•O
2
monitor/analyzer
• Nebulizer controller
Detachable
components
The V60/V60 Plus Ventilator system includes these detachable components
(see Figure 3-4 and Figure 3-5):
• Left side panel
• Right side panel
• Air inlet filter (under side panel)
Essential
performance
Per ISO/EN 80601-2-12: 2011, Medical electrical equipment Part 2-12:
Particular requirements for basic safety and essential performance of critical
care ventilators, the ventilator’s essential performance requirements are given
in “Control settings” on page 11-1, “Alarms and other messages” on page 9-
7, and “Table of monitored parameters” on page 8-2. Alarms, including O
2
supply failure alarms and gas failure alarms, are identified in “Alarms and
other messages” on page 9-7. AC mains power information is given in
“Connecting to AC power” on page 5-2. Battery backup information is given in
“About the backup battery” on page 3-10. Gas connection information is given
in “Connecting oxygen” on page 5-1 and “Installing oxygen inlet connector
and AC power cord” on page A-7.
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