System information
System classification
This system is classified as follows:
•
Class I Equipment.
• Type B Equipment.
• Type BF Equipment (airway modules).
• Ordinary Equipment.
• Not for use with flammable anesthetics.
• Continuous operation.
Device standards IEC 60601-1:2005
Devices used with this anesthesia system shall comply with the
following standards where applicable:
• Breathing system and breathing system components ISO
80601-2-13.
• Anesthetic gas scavenging systems ISO 80601-2-13
• Anesthetic vapor delivery devices ISO 80601-2-13.
• Anesthetic agent monitors ISO 80601-2-55.
• Oxygen monitors ISO 80601-2-55.
• Carbon dioxide monitors ISO 80601-2-55.
• Exhaled volume monitors ISO 80601-2-13.
Device standards IEC 60601-1:1988
Devices used with this anesthesia system shall comply with the
following standards where applicable:
• Breathing system and breathing system components ISO
8835-2.
• Anesthetic gas scavenging systems ISO 8835-3
• Anesthetic vapor delivery devices ISO 8835-4.
• Anesthetic agent monitors ISO21647.
• Oxygen monitors ISO 21647.
• Carbon dioxide monitors ISO 21647.
• Exhaled volume monitors IEC 60601-2-13.
Aisys CS²
1-14 2067226-001