16 Instructions for Use Fabius MRI SW 3.n
Intended Use
Intended Use
Fabius MRI is an inhalation anesthesia machine for
use in MRI environments in operating, induction
and recovery rooms. It can only be used in MRI
scanner rooms with magnets 1.5 tesla and 3 tesla
at a fringe field strength of 40 mtesla or less.
It may be used with O
2, N2O, and AIR supplied by
a medical gas pipeline system or by externally
mounted gas cylinders.
Fabius MRI 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)
– SIMV/PS (Optional)
– Manual Ventilation
– Spontaneous Breathing
Fabius MRI is equipped with an electrically driven
and electronically controlled ventilator and monitors
for airway pressure (P), volume (V), and inspiratory
oxygen concentration (FiO
2).
As per IEC 60601-2-13 (Anesthetic Workstations
and their Modules-Particular Requirements), addi-
tional monitoring of the concentrations of CO
2 and
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.
Indications for Use
The Fabius MRI is indicated as a continuous flow
anesthesia system useable in an MRI environment.
The Fabius MRI may be used for manually assisted
or automatic ventilation, delivery of gases and
anesthetic vapor, and monitoring of oxygen con-
centration, breathing pressure and respiratory vol-
ume.
MEDIBUS and Vitalink Protocols
MEDIBUS is a software protocol for use in transfer-
ring data between the Fabius MRI and an external
medical or non-medical device (e.g., hemodynamic
monitors, data management systems, or a Win-
dows-based computer) via the RS-232 interface
(see 9038530 3rd edition or higher).
The system must meet the requirements about
medical electrical equipment in accordance to
IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
Restriction of Distribution
WARNING
Data transferred via MEDIBUS 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, it is 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.
CAUTION
Device for use in health care facilities only and
exclusively by persons with specific training and
experience in its use.
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