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Instructions for use
|
Atlan A300, A300 XL, A350, A350 XL SW 1.0n
Safety-related information
2.4
Environments of use
The device is designed for use in rooms in which therapeutic or diagnostic
interventions can be performed under constant supervision of users. According to
IEC 60601-1-2, the use of the device is only permissible in hospitals and
comparable facilities with a Class A electromagnetic environment.
Do
not
use the device in the following environments:
– Outside buildings
– On intensive care units
– During patient transport
– In vehicles, airplanes, helicopters, and on ships
– In areas where oxygen concentrations above 25 Vol% or combustible or
explosive gas mixtures can occur.
– In rooms with magnetic field applications (e.g., magnetic resonance imaging)
2.5 Essential
performance
features
Correct functioning of the essential performance features ensures that the product
can be used in accordance with its intended use. The product has the following
essential performance features:
General
– Supply of the anesthesia workstation with O
2
:
If the O
2
supply (central gas supply or gas cylinder) fails, an alarm is issued.
– Supply of the patient with adequately oxygenated breathing gas:
If the breathing gas contains insufficient levels of O
2
, an alarm is issued.
– Supply of an adequate anesthetic gas concentration to the patient:
When the anesthetic gas is measured by means of an integrated patient-gas
measurement module, an alarm will be generated if the anesthetic gas
concentrations are too high.
– Monitoring of the airway pressure:
Alarms are issued depending on the set alarm limits.
Gas measurement
– Breathing gas monitoring:
– Set values for FiO
2
– Inspiratory and expiratory measured values for O
2
, CO
2
, N
2
O, and
anesthetic gas; automatic anesthetic agent identification (patient-gas
measurement module)
The gas composition is measured with ISO accuracy.
– Monitoring of breathing gas concentrations:
Alarms will be issued depending on the set alarm limits or if the gas
measurement fails.
