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Safety-related information
2.4
Application-specific safety aspects in general
anesthesia
The anesthesia workstation may only be used by persons who are familiar with the
medical procedures of general anesthesia and anesthesia ventilation.
Users of this device must be aware of the clinical risks and side effects of general
anesthesia and anesthesia ventilation.
Users must have particular knowledge of the following effects, side effects, and
complications and be in a position to respond to these appropriately:
– Respiratory problems, including those involving various artificial airways (e.g.,
obstruction, dislocation)
– Side effects of mechanical ventilation, including oxygen therapy (e.g., pulmonary
complications, cardiovascular depression)
– Interindividual and intraindividual variability in the effect and potential side
effects of the anesthetic agents administered, depending on:
– Dosage
– Underlying and accompanying diseases
– General condition of the patient
– Demographic and other patient-specific factors
2.5
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, use of the device is only permissible in health-care 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)
2.6
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
If the O
– Supply of the patient with adequately oxygenated breathing gas:
If the breathing gas contains insufficient levels of O
10
supply (central gas supply or gas cylinder) fails, an alarm is issued.
2
|
Instructions for use
:
2
, an alarm is issued.
2
Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
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