Dräger Zeus Infinity Empowered Instructions For Use Manual page 415

General safety standards for anesthesia workstations (Cont.)
For devices manufactured after January 2016, the
following also apply:
IEC 60601-1 3rd ed.
Medical electrical equipment
IEC 60601-1-2
Medical electrical equipment
IEC 60601-1-8
ISO 80601-2-13
Medical electrical equipment
ISO 80601-2-55
Observe the conditions of use for auxiliary devices. The application of the whole system may be restricted
as a result.
Observe the instructions for use for auxiliary devices and the technical data specified therein.
The anesthetic agent used can restrict the application range of the device with respect to the temperature
range as well as the maximum fresh-gas flow.
Instructions for use Zeus Infinity Empowered SW 2.n
Part 1:
General requirements for basic safety and essen-
tial performance
Part 1-2:
General requirements for safety – Collateral stand-
ard: Electromagnetic compatibility – requirements
and tests
Part 1-8:
General requirements for basic safety and essen-
tial performance – Collateral standard: Alarm sys-
tems – General requirements, tests and guidance
for alarm systems in medical electrical equipment
and medical systems
Part 2-13:
Particular requirements for basic safety and essen-
tial performance of anaesthesia workstations
Part 2-55:
Particular requirements for basic safety and essen-
tial performance of respiratory gas monitors
Technical data
415