Intended Use - Dräger Fabius OS Instructions For Use Manual

Intended Use

Intended Use
Fabius OS is an inhalation anesthesia machine for
use in operating, induction and recovery rooms.
It may be used with O
2
a medical gas pipeline system or by externally
mounted gas cylinders.
Fabius OS is equipped with a compact breathing
system, providing fresh gas decoupling, PEEP, and
pressure limitation.
The following ventilation options are available:
– Volume Controlled Ventilation
– Pressure Controlled Ventilation
– Pressure Support (Optional)
– Manual Ventilation
– Spontaneous Breathing
Fabius OS is equipped with an electrically driven
and electronically controlled ventilator and monitors
for airway pressure (P), volume (V), and inspiratory
oxygen concentration (FiO
As per IEC 60601-2-13 (Anesthetic Workstations
and their Modules-Particular Requirements), additi-
onal monitoring of the concentrations of CO
anesthetic agent is required when the machine is in
use.
IEC 60601-2-13: 2003 requires that a manual ven-
tilation bag must be available for emergency use.
Fresh gas enrichment is provided by the Dräger
Vapor anesthetic vaporizer.
14
, N O, and AIR supplied by
2
).
2
2
MEDIBUS and Vitalink Protocols
MEDIBUS and Vitalink are software protocols for
use in transferring data between the Fabius OS
and an external medical or non-medical device
(e.g., hemodynamic monitors, data management
systems, or a Windows-based computer) via the
RS-232 interface (see 9038530, 3rd edition or hig-
her).
WARNING
Data transferred via MEDIBUS and Vitalink
interfaces are for information only and are not
intended as a basis for diagnosis or therapy
decisions.
WARNING
In order to protect patients and users from
electrical hazards, is it imperative that all sys-
tems consisting of electrical medical devices
and other electrical devices, such as but not
limited to PCs, printers, etc., be mounted
exclusively by trained personnel.
The system must meet the requirements about
medical electrical equipment in accordance to
and
IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
Restriction of Distribution
CAUTION
Device for use in health care facilities only and
exclusively by persons with specific training and
experience in its use.
Instructions for Use Fabius OS SW 3.n