Dräger Fabius plus XL Owner's manual

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

Supplement Fabius plus XL SW 3.n 11
Overview
Product labels
The following product labels have changed:
Product label Explanation
When connecting auxiliary devices, be aware of
the leakage current.
Transport information, see chapter "Preparing for
storage or transport".
Use of the external fresh-gas outlet with an addi-
tional switch:
When a controlled ventilation mode (Volume Con-
trol, Pressure Control, Pressure Support,
SIMV/PS) or the ManSpont ventilation mode is
used, set the switch on the external fresh-gas out-
let to the COSY position.
For further information, see "Using the external
fresh-gas outlet with an additional switch
(optional)" in the "Operation" chapter in the instruc-
tions for use.
COSY

Assembly and preparation
12 Supplement Fabius plus XL SW 3.n
Assembly and preparation
Before first operation
Activating the battery
The following safety information has changed:
WARNING
Risk due to reduced power supply from the
internal battery
The charging capacity of the battery may be
reduced as a result of long-term storage.
If the battery has not been charged for 6
months, check its functional integrity. To do
this, charge the battery for 16 hours and
ventilate a test lung for at least 45 minutes in
battery operation.

Supplement Fabius plus XL SW 3.n 13
Assembly and preparation
Assembling the breathing system
The following chapters have changed:
Connecting the breathing hoses and the
filters
The data for the tidal volumes for adults and pediatric patients
have been changed:
1Select suitable accessories for the respective
patient category.
Adults Pediatric patients Neonates
Tidal volume >700 mL 301 to 700 mL 50 to 300 mL <50 mL
Breathing bag 3L 2L 1L 0.5L
Breathing circuit Adults Pediatric Neonates
(or pediatric)
Filter Filter, HMEF, or HME Use filters with low
resistance and
compliance.

Assembly and preparation
14 Supplement Fabius plus XL SW 3.n
Inserting a new O2sensor capsule
The terminology for the O2 sensor has changed.
1Remove the O2sensor (A) from the inspiratory
valve.
2Unscrew the screw cap (C) from the O2sensor
housing.
3Take the new O2sensor capsule from the
package.
4Place the O2sensor capsule (B) in the O2
sensor housing so that the ring-shaped
conductors touch the contacts in the O2sensor
housing.
5Screw on the screw cap (C) tightly by hand.
6Insert the O2sensor (A) back in the inspiratory
valve.
WARNING
Risk of electric shock
If the O2sensor capsule is replaced during
operation, leakage currents may be
transferred.
Do not touch the patient.
20971
C
B
A
WARNING
Risk of incorrect O2measurement
An incorrectly fitted O2sensor capsule will
result in incorrect measurements.
– Make sure that the O2sensor capsule is
correctly inserted in the O2sensor
housing.
– Make sure that the O2sensor is correctly
inserted in the inspiratory valve.

Supplement Fabius plus XL SW 3.n 15
Assembly and preparation
Connecting the sensors and the measuring lines
The following chapter has been added:
Connecting the APL bypass hose and
PEEP/PMAX hose
On devices with the "External fresh-gas outlet with
an additional switch and ventilator lock" option, the
following must be observed when connecting the
APL bypass hose:
The APL bypass hose consists of a long hose with
a T-piece and a short hose.
1Connect the long APL bypass hose to
connectors A and B.
2Connect the short APL bypass hose to
connectors E and F.
3Connect the PEEP/PMAX hose to connectors C
and D.
42593
NOTE
The APL bypass hose is thicker than the
PEEP/PMAX hose.
COM1
PEEP
O
APL
COM2
2
A
F
B
D
EC

Operation
16 Supplement Fabius plus XL SW 3.n
Operation
Ventilation
The following chapters have been added or have changed:
Interdependency between the control
elements
Some settable parameters may be limited or
mutually restrict one another, so that certain
combinations of therapy settings are not possible,
e.g., VT and Freq in the Volume Control
ventilation mode.
If a condition is reached in which a parameter can
no longer be changed, the restricting parameter
must first be adjusted. This will enable the
adjustment of the restricted parameter.
External fresh-gas outlet with switch
and ventilator lock (option)
When the switch of the external fresh-gas outlet is
set to operation with a non-rebreathing system
, the ventilator lock prevents a controlled
ventilation mode (Volume Control, Pressure
Control, Pressure Support, SIMV/PS) from being
started.
The following alarms are issued:
From software version 3.37:
–VENTILATOR FAIL !!!
–CHECK APL / EXT. FGO !!!
With older software versions:
–VENTILATOR FAIL !!!
–CHECK APL VALVE !!!
1Set the switch of the external fresh-gas outlet
to COSY.
The function of the ventilator lock is only available
with the “External fresh-gas outlet with switch and
ventilator lock” option.
This function is not available on older versions of
the external fresh-gas outlet with switch.
Ventilation mode ManSpont
The following information has been added:
For ventilation in the ManSpont ventilation mode,
use a tight-fitting mask or a tube.
CAUTION
Risk of undetected fresh-gas deficiency
When the switch of the external fresh-gas outlet
is set to operation with a non-rebreathing system
[ ], no alarm occurs at the start of the
ManSpont ventilation mode.
Check that the switch of the external fresh-gas
outlet has been set to COSY.
41673
COSY

Supplement Fabius plus XL SW 3.n 17
Operation
Safety functions of the ventilator
Behavior of Fabius if the user does not
take any action
The following safety information has changed:
WARNING
Risk of patient regaining consciousness or
risk of hypoxia
If the gas supply fails, further operation of the
anesthesia machine takes place with ambient
air. Oxygen and anesthetic gas are no longer
delivered. Due to the patient’s rebreathing,
the inspiratory concentration of anesthetic
gases and oxygen in the breathing gas falls.
Monitor the gas concentrations carefully and
use intravenous anesthetic agents if
necessary.

Operation
18 Supplement Fabius plus XL SW 3.n
Using the external fresh-gas outlet with switch and ventilator lock
(option)
The following chapters have been changed:
Preparation
Example: Bain non-rebreathing system
1Connect the non-rebreathing system (B) to the
external fresh-gas outlet (A).
2Screw on the sample line (C) to the Luer Lock
connector of the ventilation mask or of the
breathing system filter and to the water trap on
the gas monitor.
3If necessary, connect the non-rebreathing
system scavenging hose to the second
connection (D) of the anesthetic gas receiving
system.
Observe the instructions for use of the non-
rebreathing system and the anesthetic gas
receiving system.
WARNING
Insufficient gas supply to the patient
Non-rebreathing systems are only intended
for manual ventilation or spontaneous
breathing and must only be connected to the
external fresh-gas outlet.
When using a non-rebreathing system,
ensure an adequate gas monitoring.
WARNING
Risk of misinterpretation of measured values
The values for O2, pressure, and volume
displayed on Fabius do not correspond to the
values for the patient connected to external
fresh-gas outlet as they are based on
measurements taken at the compact
breathing system.
When using the external fresh-gas outlet,
change into the Standby mode.
WARNING
Risk of faulty gas delivery
O2and CO2and any anesthetic gases must
also be monitored for non-rebreathing
systems.
The sample line must be connected with the
connector of the non-rebreathing system and
the connector of the gas analyzer (e.g., Scio,
Vamos).
4171621020
A
C
B
D

Supplement Fabius plus XL SW 3.n 19
Operation
Operation with non-rebreathing system
Diverting the fresh-gas flow to the non-rebreathing
system:
1Set the switch to .
The switch points in the direction of the non-
rebreathing system.
2Set the fresh-gas flow.
To prevent rebreathing, the fresh-gas supply
must be at least double the minute volume.
3Operate the non-rebreathing system according
to the corresponding instructions for use.
Operation with the compact breathing
system (COSY)
Before using a controlled ventilation mode
(Volume Control, Pressure Control, Pressure
Support, SIMV/PS) or the ManSpont ventilation
mode:
1Set the switch to COSY.
The switch points in the direction of the fresh-
gas inlet.
2Screw the sample line back to the Y-piece on
the breathing circuit.
When the switch of the external fresh-gas outlet is
set to operation with a non-rebreathing system
, the ventilator lock prevents a controlled
ventilation mode (Volume Control, Pressure
Control, Pressure Support, SIMV/PS) from being
started.
The following alarms are issued:
From software version 3.37:
–VENTILATOR FAIL !!!
–CHECK APL / EXT. FGO !!!
With older software versions:
–VENTILATOR FAIL !!!
–CHECK APL VALVE !!!
Ending operation
1Close all flow control valves on the device.
4171841673
Pmax= 125 hPa
COSY
CAUTION
Risk of undetected fresh-gas deficiency
When the switch of the external fresh-gas outlet
is set to operation with a non-rebreathing system
[ ], no alarm occurs at the start of the
ManSpont ventilation mode.
Check that the switch of the external fresh-gas
outlet has been set to COSY.

Operation
20 Supplement Fabius plus XL SW 3.n
Ending operation
The following safety information has been added:
Preparing for storage or transport
The following safety information has changed:
WARNING
Risk of infection
Pathogenic germs can be transmitted
between patients by the circuit plug. If a
previously used Y-piece or filter is plugged
onto the circuit plug and if a reprocessed
component is attached later in the process
(e.g., during a leakage test), the new
component may become contaminated.
Only plug reprocessed components onto the
circuit plug.
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.