Dräger Fabius plus Manual del propietario
Supplement
Fabius plus
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 SW 3.n
Fabius plusAnesthesia 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 9054673 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 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:
Accessories in sterile packaging
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 46).
This device can be affected by other electrical
devices.
CAUTION
Risk of medical device failure and patient injury
– Do not use accessories in sterile packaging if
the packaging has been opened, damaged,
or if there are other signs that the accessories
are not sterile.
– Reuse, reprocessing, and sterilization of
disposable products is not permitted.
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 46).
For your safety and that of your patients
4 Supplement Fabius plus SW 3.n
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.
Supplement Fabius plus SW 3.n 5
For your safety and that of your patients
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.
Application
6 Supplement Fabius plus SW 3.n
Application
The MEDIBUS and Vitalink protocols
The following safety information has been amended:
The following safety information has been added:
Overview
Compact breathing system COSY (top view)
The following designation has changed:
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.
NConnection for sample gas return line
Supplement Fabius plus SW 3.n 7
Overview
The views of the power supply unit for the COSY heater have
changed:
Power supply unit for COSY heating (front view)
ALED indicator for COSY heating
BOn/Off switch
CFuse
21014
A
B
C
Overview
8 Supplement Fabius plus SW 3.n
Power supply unit for COSY heating (rear view)
APower inlet
BLED indicator for power supply
CCable clamp
21015
A
B
C
Supplement Fabius plus SW 3.n 9
Overview
Interface panel
The designation of the fuse and the power inlet has changed.
ACOM 1 port
BConnection for PEEP hose
CConnection for APL hose
DSocket for O2sensor
ESocket for airway pressure sensor
FSocket for flow sensor
GPower inlet with power fuses
HOn/Off switch
IFuse for internal battery
JPotential equalization pin
25301
A
B
C
D
E
F
G
H
I
J
Overview
10 Supplement Fabius plus SW 3.n
Ceiling-mounted version (optional)
The "Caution - Risk of tipping over" safety information has been
omitted and the following warning has been added in its place:
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.
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2
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