Dräger Fabius plus XL Betriebsanleitung
Supplement
Fabius plus XL
WARNING
To properly use this medical device,
read and comply with the
instructions for use and this
supplement.
Anesthesia workstation
Software 3.n
Supplement to the instructions for use
2 Supplement Fabius plus XL SW 3.n
Fabius plus XLAnesthesia workstation
Supplement to the instructions for use
Keep this supplement with the instructions for
use of the medical device.
The supplement updates the information of the
instructions for use in the following chapters:
Trademarks
The following trademarks have been added:
Device Part number Edition
Fabius plus XL 9054695 up to 1. Edition
Trademark Trademark owner
Actichlor®Ecolab
BruTab 6S®Brulin
Buraton®
Schülke & Mayr
Mikrozid®
Perform®
Descogen®Antiseptica
Dismozon®Bode Chemie
Klorsept®Medentech
Oxycide®Ecolab USA
Virkon®DuPont
Supplement Fabius plus XL SW 3.n 3
For your safety and that of your patients
For your safety and that of your patients
General safety information
The following safety information has been added:
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility. During installation
and before initial operation, follow the information
in section: "EMC declaration" (page 42).
This device can be affected by other electrical
devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against
electrostatic discharge are employed in the
following situations:
– When touching the pins of connectors
that carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the
following measures and train the relevant
personnel:
– Observe the ESD protective measures.
Such measures may include wearing
antistatic clothing and shoes, touching a
potential equalization pin before and while
making the connection, or using
electrically insulating and antistatic
gloves.
– Observe the requirements for the
electromagnetic environment. Observe
the following section: "Electromagnetic
environment" (page 42).
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g.,
cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical
devices) emit electromagnetic radiation.
When such devices are operated too close to
this device or its cables, the functional
integrity of this device may be compromised
by electromagnetic disturbances. As a result,
the patient could be put at risk.
– Maintain a distance of at least 0.3 m (1.0 ft)
between this device and wireless
communication devices, to ensure that the
essential performance of this device is
fulfilled.
– Maintain an adequate distance between
this device and other medical electrical
equipment.
For your safety and that of your patients
4 Supplement Fabius plus XL SW 3.n
Product-specific safety information
The following safety information has been amended:
The following safety information has been deleted:
WARNING
Risk of tipping over during transport
The medical device may tip over if handled
incorrectly. Observe the following when
transporting the medical device:
– The medical device may only be moved by
people who have the physical ability to do
so.
– To improve the maneuverability, transport
the device with 2 persons.
– When transporting over inclines, around
corners, or over thresholds (e.g., through
doors or in elevators), make sure that the
medical device does not bump against
anything.
– Remove any devices mounted to the
holding arms or the top of the device.
– Clear the writing tray and slide it
completely into the device.
– Do not pull the medical device over hoses,
cables, or other obstacles lying on the
floor.
– Do not activate the brake while the
medical device is being moved.
– Use only the handles provided to push or
pull the device.
WARNING
Risk of device failure
The device can fail if the power supply is
interrupted.
Always connect the device on an
uninterruptible power supply.
Supplement Fabius plus XL SW 3.n 5
Application
Application
The MEDIBUS and Vitalink protocols
The following safety information has been amended:
The following safety information has been added:
WARNING
Risk of not hearing alarm signals
If the alarm volume is too low, alarm signals
may not be heard.
– Set the alarm volume loud enough so that
the alarm signals can be heard in the
environment where the device is located.
– The user must remain within earshot of
the alarm signals.
NOTE
The use of a serial interface for an analog or
optical link and the routing of data via the
MEDIBUS or Vitalink protocol to external
devices, systems, or networks (LAN, WLAN,
PDMS etc.) is the responsibility solely of the
system manufacturer or the operating
organization.
During operation, the alarms and indicators on
the anesthesia workstation are binding and must
be adhered to.
Overview
6 Supplement Fabius plus XL SW 3.n
Overview
Interface panel
The names of some of the connections have changed.
ASocket for O2sensor
BOn/Off switch
CInterface COM1
DInterface COM2 (optional)
ESocket for flow sensor
FSocket for airway pressure sensor
GConnection for APL hose
HConnection for PEEP hose
IPower inlet with power fuses
JFuse for internal battery
KPotential equalization pin
LIntegrated power sockets (optional)
(connectors in accordance with national
standards)
MMain fuse
NPotential equalization for power socket strip
OPower cable clamps
PCircuit breaker for power sockets
42592
AB
C
D
E
F
G
H
I
J
K
L
M
NOP
Supplement Fabius plus XL SW 3.n 7
Overview
Ceiling-mounted version (optional)
The following safety information has been amended:
WARNING
Risk of tipping over
The ceiling-mounted version of the device
does not meet the requirements of ISO 80601-
2-13 and IEC 60601-1 with regard to tipping
stability and transport stability. Precautionary
measures must be taken. The medical device
may tip over if handled incorrectly.
– The medical device may only be moved by
people who have the physical ability to do
so.
– Use 2 persons to transport the device.
– Make sure that there is sufficient clear
space.
– Remove any devices mounted on attached
support arms or on the top of the device.
– Fold in the support arms.
– Clear the writing tray and push it in
completely.
Overview
8 Supplement Fabius plus XL SW 3.n
Wall-mounted version (optional)
The following safety information has been amended:
WARNING
Risk of tipping over
The wall-mounted version of the device does
not meet the requirements of ISO 80601-2-13
and IEC 60601-1 with regard to tipping
stability and transport stability. Precautionary
measures must be taken. The medical device
may tip over if handled incorrectly.
– The medical device may only be moved by
people who have the physical ability to do
so.
– Use 2 persons to transport the device.
– Make sure that there is sufficient clear
space.
– Remove any devices mounted on attached
support arms or on the top of the device.
– Fold in the support arms.
– Clear the writing tray and push it in
completely.
Supplement Fabius plus XL SW 3.n 9
Overview
External fresh-gas outlet
The section "Using the external fresh-gas outlet as
a common gas outlet" no longer applies.
The following section has changed:
Using the external fresh-gas outlet with
switch and ventilator lock (option)
The switch enables the simple switching of the
fresh-gas supply from the compact breathing
system to the non-rebreathing system.
Overview
AExternal fresh-gas outlet with an additional
switch
BLong fresh-gas hose (on Fabius)
CAPL bypass hose for the ventilator lock
DShort fresh-gas hose (on compact breathing
system)
ECompact breathing system
FSample line
GNon-rebreathing system (e.g., Bain)
41644
AB
C
D
E
F
G
Overview
10 Supplement Fabius plus XL SW 3.n
Abbreviations
The abbreviation BTPS has been removed. The abbreviations
TI and STPD were added or changed.
Symbols
The following symbols have been added or have changed:
Abbreviation Explanation
RI Revision Index
STPD Standard Temperature and Pres-
sure, Dry
20 °C (68 °F), 1013 hPa, dry gas
Symbol Explanation
Applied part of type BF (body
floating)
Applied part of type B
Keep free of oil and grease
DC voltage
AC voltage
Fragile, handle with care
Keep dry
Connection for sample gas
return line
The fiollowing symbol has been deleted:
Caution! Risk of electric shock.
Do not remove cover.
gas return
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