Supplement

Fabius plus XL

WARNING Anesthesia workstation

To properly use this medical device, Software 3.n
read and comply with the
instructions for use and this
supplement.
Supplement to the instructions for use

Supplement to the instructions for use

Fabius plusworkstation
Anesthesia XL

Device Part number Edition

Fabius plus XL 9054695 up to 1. Edition

 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:

Trademark Trademark owner

Actichlor® Ecolab
® Brulin
BruTab 6S
Buraton®
Mikrozid® Schülke & Mayr

Perform®
Descogen® Antiseptica

Dismozon® Bode Chemie

® Medentech
Klorsept
Oxycide® Ecolab USA

Virkon® DuPont

2 Supplement Fabius plus XL SW 3.n

 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:

WARNING
Electromagnetic compatibility (EMC) Risk due to electromagnetic disturbance
Medical electrical equipment is subject to special Wireless communication devices (e.g.,
precautionary measures concerning cellular phones) and medical electrical
electromagnetic compatibility. During installation equipment (e.g., defibrillators, electrosurgical
and before initial operation, follow the information devices) emit electromagnetic radiation.
in section: "EMC declaration" (page 42). When such devices are operated too close to
This device can be affected by other electrical this device or its cables, the functional
devices. integrity of this device may be compromised
by electromagnetic disturbances. As a result,
the patient could be put at risk.
WARNING
– Maintain a distance of at least 0.3 m (1.0 ft)
Risk due to electrostatic discharge between this device and wireless
communication devices, to ensure that the
Malfunctions that endanger the patient may essential performance of this device is
occur if no protective measures against fulfilled.
electrostatic discharge are employed in the – Maintain an adequate distance between
following situations: this device and other medical electrical
– When touching the pins of connectors equipment.
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).

Supplement Fabius plus XL SW 3.n 3

For your safety and that of your patients

Product-specific safety information

The following safety information has been amended:

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.

The following safety information has been deleted:

WARNING
Risk of device failure
The device can fail if the power supply is
interrupted.
Always connect the device on an
uninterruptible power supply.

4 Supplement Fabius plus XL SW 3.n

 Application

Application

The MEDIBUS and Vitalink protocols

The following safety information has been amended:

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.

The following safety information has been added:

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.

Supplement Fabius plus XL SW 3.n 5

Overview

Overview

Interface panel

The names of some of the connections have changed.

42592
N O P A B

M
L C
D
E
K F
G
J
H
I

A Socket for O2 sensor L Integrated power sockets (optional)

B On/Off switch (connectors in accordance with national
standards)
C Interface COM1
M Main fuse
D Interface COM2 (optional)
N Potential equalization for power socket strip
E Socket for flow sensor
O Power cable clamps
F Socket for airway pressure sensor
P Circuit breaker for power sockets
G Connection for APL hose
H Connection for PEEP hose
I Power inlet with power fuses
J Fuse for internal battery
K Potential equalization pin

6 Supplement Fabius plus XL SW 3.n

 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.

Supplement Fabius plus XL SW 3.n 7

Overview

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.

8 Supplement Fabius plus XL SW 3.n

 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

A B
41644

D
F C
E

A External fresh-gas outlet with an additional

switch
B Long fresh-gas hose (on Fabius)
C APL bypass hose for the ventilator lock
D Short fresh-gas hose (on compact breathing
system)
E Compact breathing system
F Sample line
G Non-rebreathing system (e.g., Bain)

Supplement Fabius plus XL SW 3.n 9

Overview

Abbreviations

The abbreviation BTPS has been removed. The abbreviations

TI and STPD were added or changed.

Abbreviation Explanation
RI Revision Index
STPD Standard Temperature and Pres-
sure, Dry
20 °C (68 °F), 1013 hPa, dry gas

Symbols

The following symbols have been added or have changed:

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

gas return Connection for sample gas

return line
The fiollowing symbol has been deleted:

Caution! Risk of electric shock.

Do not remove cover.

10 Supplement Fabius plus XL SW 3.n

 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-
COSY 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.

Supplement Fabius plus XL SW 3.n 11

Assembly and preparation

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.

12 Supplement Fabius plus XL SW 3.n

 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:
1 Select 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 0.5 L
Breathing circuit Adults Pediatric Neonates
(or pediatric)
Filter Filter, HMEF, or HME Use filters with low
resistance and
compliance.

Supplement Fabius plus XL SW 3.n 13

Assembly and preparation

Inserting a new O2 sensor capsule WARNING

The terminology for the O2 sensor has changed.
Risk of incorrect O2 measurement
WARNING An incorrectly fitted O2 sensor capsule will
result in incorrect measurements.
Risk of electric shock – Make sure that the O2 sensor capsule is
If the O2 sensor capsule is replaced during correctly inserted in the O2 sensor
operation, leakage currents may be housing.
transferred. – Make sure that the O2 sensor is correctly
inserted in the inspiratory valve.
Do not touch the patient. 20971

1 Remove the O2 sensor (A) from the inspiratory

valve.
2 Unscrew the screw cap (C) from the O2 sensor
housing.
3 Take the new O2 sensor capsule from the
package.
4 Place the O2 sensor capsule (B) in the O2
sensor housing so that the ring-shaped
conductors touch the contacts in the O2 sensor
housing.
5 Screw on the screw cap (C) tightly by hand.
6 Insert the O2 sensor (A) back in the inspiratory
valve.

14 Supplement Fabius plus XL SW 3.n

 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:

42593

COM1

COM2

O2 B
PEEP APL
E C

F A

The APL bypass hose consists of a long hose with

a T-piece and a short hose.
1 Connect the long APL bypass hose to
connectors A and B.
2 Connect the short APL bypass hose to
connectors E and F.
3 Connect the PEEP/PMAX hose to connectors C
and D.

NOTE
The APL bypass hose is thicker than the
PEEP/PMAX hose.

Supplement Fabius plus XL SW 3.n 15

Operation

Operation

Ventilation

The following chapters have been added or have changed:

41673
COSY
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 1 Set the switch of the external fresh-gas outlet
and ventilator lock (option) to COSY.

When the switch of the external fresh-gas outlet is The function of the ventilator lock is only available
set to operation with a non-rebreathing system with the “External fresh-gas outlet with switch and
, the ventilator lock prevents a controlled ventilator lock” option.
ventilation mode (Volume Control, Pressure This function is not available on older versions of
Control, Pressure Support, SIMV/PS) from being the external fresh-gas outlet with switch.
started.
The following alarms are issued: Ventilation mode ManSpont
From software version 3.37: The following information has been added:

– VENTILATOR FAIL !!! For ventilation in the ManSpont ventilation mode,

use a tight-fitting mask or a tube.
– CHECK APL / EXT. FGO !!!
With older software versions:
– VENTILATOR FAIL !!!
– CHECK APL VALVE !!!

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.

16 Supplement Fabius plus XL SW 3.n

 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.

Supplement Fabius plus XL SW 3.n 17

Operation

Using the external fresh-gas outlet with switch and ventilator lock
(option)

The following chapters have been changed:

WARNING
Insufficient gas supply to the patient Preparation
Non-rebreathing systems are only intended Example: Bain non-rebreathing system
for manual ventilation or spontaneous
C A

41716
breathing and must only be connected to the
external fresh-gas outlet.
B
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
1 Connect the non-rebreathing system (B) to the
measurements taken at the compact
external fresh-gas outlet (A).
breathing system.
2 Screw on the sample line (C) to the Luer Lock
When using the external fresh-gas outlet, connector of the ventilation mask or of the
change into the Standby mode. breathing system filter and to the water trap on
the gas monitor.
WARNING

21020
Risk of faulty gas delivery
O2 and CO2 and any anesthetic gases must
also be monitored for non-rebreathing
systems. D
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).

3 If 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.

18 Supplement Fabius plus XL SW 3.n

 Operation

Operation with non-rebreathing system 1 Set the switch to COSY.

The switch points in the direction of the fresh-

41718
gas inlet.
125 hPa
Pmax=

2 Screw the sample line back to the Y-piece on

the breathing circuit.

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.
Diverting the fresh-gas flow to the non-rebreathing
system: When the switch of the external fresh-gas outlet is
1 Set the switch to . set to operation with a non-rebreathing system
The switch points in the direction of the non- , the ventilator lock prevents a controlled
rebreathing system. ventilation mode (Volume Control, Pressure
Control, Pressure Support, SIMV/PS) from being
2 Set the fresh-gas flow. started.
To prevent rebreathing, the fresh-gas supply The following alarms are issued:
must be at least double the minute volume.
From software version 3.37:
3 Operate the non-rebreathing system according
to the corresponding instructions for use. – VENTILATOR FAIL !!!
– CHECK APL / EXT. FGO !!!
Operation with the compact breathing
With older software versions:
system (COSY)
– VENTILATOR FAIL !!!
41673

– CHECK APL VALVE !!!

COSY

Ending operation
1 Close all flow control valves on the device.

Before using a controlled ventilation mode

(Volume Control, Pressure Control, Pressure
Support, SIMV/PS) or the ManSpont ventilation
mode:

Supplement Fabius plus XL SW 3.n 19

Operation

Ending operation

The following safety information has been added:

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.

Preparing for storage or transport

The following safety information has changed:

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.

20 Supplement Fabius plus XL SW 3.n

 Configuration

Configuration

Configuration in Standby mode

Leakage test Results of the compliance test

The following text has changed: The value for the system compliance has changed:

Safety valve test System compliance Displayed result

[mL/cmH2O] [mL/cmH2O]
This test checks the functional integrity of the
safety valves. ≤ Measured value and
6.0 PASSED
The test results are displayed on the screen with
the leakage test results (B).

Troubleshooting in the event of a failed safety

valve test
The following safety information has changed:

WARNING
Risk of unexpectedly occurring overpressure
or negative pressure
A soiled or non-functioning safety valve is
not able to compensate for suddenly
occurring overpressure or negative pressure
in the breathing system.
Perform the leakage test before start-up of
the device. Observe the result of the safety
valve test.

 Repeat leakage test. Do not operate the device

if the safety valve test continues to fail. Contact
DrägerService or the authorized local service
partner

Supplement Fabius plus XL SW 3.n 21

Configuration

Page Standby Set-up

Changing the configurations The following units can be selected:

Changing the pressure unit – hPa
– cmH2O
The following text has changed:
– mbar
Standby Set-up – kPa

22136
3 Select new unit and confirm.
The window is closed.

1 Select menu item Pressure Unit (G) and

confirm.
The screen with the password query opens.
22107

Standby Set-up

2 Enter the password (H) and confirm.

22 Supplement Fabius plus XL SW 3.n

 Troubleshooting

Troubleshooting

Power supply failure

Mains power supply failure The following safety information has been amended:

The following text has changed:

WARNING
If mains power fails, Fabius automatically switches
to the internal battery. Insufficient ventilation of the patient

The remaining battery charge is displayed in the When the BATTERY LOW !! alarm message
status bar. (remaining battery charge 10 %) is displayed,
the ventilator will continue to operate for only
The operating time of the battery depends on the a few minutes more.
ventilation settings and the condition of the battery
(age and battery charge). A completely charged Restore mains power supply. Afterwards, the
battery can ensure supply for at least 45 minutes. controlled ventilation is available again.

Ventilator failure

Alarm VENTILATOR FAIL !!!

The first step has been added:
1 Set the switch of the external fresh-gas outlet
with ventilator lock (option) to COSY.
2 Change to ManSpont ventilation mode.
3 Set the APL valve to the Man position.
4 Set the APL valve to the desired pressure.
5 Fill the breathing bag, if necessary with the aid
of the O2 flush key.
6 Manually ventilate the patient.

Supplement Fabius plus XL SW 3.n 23

Troubleshooting

Failure of the O2 sensor

The terminology for the O2 sensor has changed.

Causes for faulty calibration

The calibration was not successful if, after the
calibration of the O2 sensor, the alarm message
O2 SENSOR FAIL ! is displayed.
Possible causes and remedial measures are
described in the following table.

Cause Remedy
During the calibration, the O2 sensor was exposed Make sure that the O2 sensor is exposed to ambi-
to an air mixture with extremely high or low oxygen ent air during the entire calibration.
concentration.
During the calibration, the O2 sensor was exposed Make sure that the O2 sensor is exposed to ambi-
to an air mixture with fluctuating oxygen concentra- ent air during the entire calibration.
tion.
The O2 sensor was not exposed to ambient air long Expose the O2 sensor to ambient air for 2 minutes.
enough before the calibration. If a new O2 sensor capsule has been inserted,
expose the O2 sensor to ambient air for
15 minutes.
The maximum period of use of the O2 sensor cap- Replace the O2 sensor capsule. Expose the O2
sule has elapsed. sensor to ambient air for 15 minutes before calibra-
tion.
The O2 sensor is not connected. Check that the plug on the O2 sensor cable is
plugged into the marked connector on the rear of
the device.
Check that the O2 sensor capsule has been cor-
rectly inserted into the O2 sensor housing.
Connect the O2 sensor correctly and recalibrate.

24 Supplement Fabius plus XL SW 3.n

 Troubleshooting

Alarm – Cause – Remedy

The terminology for the O2 sensor has changed.

Alarm Alarm Cause Remedy

priority
(8) O2 SENSOR FAIL ! The O2 sensor was not cor- Perform the procedure for
rectly calibrated. calibration of the O2 sensor
(see chapter on calibrating
the O2 sensor).
O2 sensor capsule replaced Perform the procedure for
and/or the O2 sensor not cali- calibration of the O2 sensor
brated. (see chapter on calibrating
the O2 sensor).
O2 sensor capsule used up. Replace O2 sensor capsule
and calibrate.
O2 sensor not connected. Connect the O2 sensor
Sensor cable faulty. cable. Replace O2 sensor
housing unit.
(6) O2 SENSOR CAL DUE ! More than 18 hours have Perform the procedure for
passed since the last O2 sen- calibration of the O2 sensor
sor calibration. (see chapter on calibrating
the O2 sensor).

The causes and remedies for the following alarms have been
changed.

Alarm Alarm Cause Remedy

priority
(31) INSP O2 LOW !!! Inspiratory O2 concentration Check O2 supply. Check
is below the lower alarm limit. the setting of the flow con-
trol valve and lower O2
alarm limit.
Incorrect setting of the switch Check the setting of the
on the external fresh-gas out- switch on the external
let. fresh-gas outlet.
(21) FRESH GAS LOW !! Insufficient fresh-gas supply Ensure sufficient fresh-gas
in all ventilation modes. supply.
Hose blocked/kinked. Check hoses.
Leakage in the breathing sys- Check breathing system.
tem.
Hose not connected to the
breathing system.
Incorrect setting of the switch Check the setting of the
on the external fresh-gas out- switch on the external
let. fresh-gas outlet.

Supplement Fabius plus XL SW 3.n 25

Troubleshooting

Alarm Alarm Cause Remedy

priority
(28) VENTILATOR FAIL !!! Fault in APL bypass valve. Check membrane of the
ventilator and close cover.
Check the connection of
the APL bypass valve for
correct connection and for
leakage. Select Standby
mode and then switch to
the previous ventilation
mode. Check APL valve
setting.
Switch of the external fresh- Set the switch of the exter-
gas outlet with switch and nal fresh-gas outlet to the
ventilator lock in the wrong COSY position.
position ( ), instead of
the COSY position.

The following alarm has been added:

Alarm Alarm Cause Remedy

priority
(26) CHECK APL / EXT. FGO !!! Fault in APL bypass valve. Check membrane of the
ventilator and close cover.
Check the connection of
the APL bypass valve for
correct connection and for
leakage. Select Standby
mode and then switch to
the previous ventilation
mode. Check APL valve
setting.
Switch of the external fresh- Set the switch of the exter-
gas outlet in the wrong posi- nal fresh-gas outlet to the
tion ( ), instead of the COSY position.

COSY position.

26 Supplement Fabius plus XL SW 3.n

 Reprocessing

Reprocessing

The chapter heading “Cleaning, Disinfection,and Sterilization”

has changed.

Disassembly

The following safety information has been added:

WARNING
Information concerning dismounted Risk of infection
accessory parts and attached devices If no microbial filters are used, the breathing
Observe the instructions for use of the following system may become contaminated with
accessory parts: pathogens.

Attached devices In this case, reprocess the breathing system

after every change of patient and insert a new
– Endotracheal suction oxygen capsule.
– Hinged arms
– Monitors The following safety information has changed:

– Sensors and cables CAUTION

– IT systems
Risk of damage to device and risk of injury
– AGS
Reprocessing or sterilization can result in failure
– Workstation illumination of the O2 sensor. Escaping substances can
damage the basic device and endanger the
patient and the user.
Do not reprocess or sterilize the O2 sensor.

Removing the compact breathing system

The terminology for the O2 sensor has changed.

Before removing the compact breathing system,

the following hoses and cables must be removed:
– Flow sensor cable
– O2 sensor cable and O2 sensor
– Pressure measurement hose
– APL bypass hose
– PEEP/PMAX hose

Supplement Fabius plus XL SW 3.n 27

Reprocessing

The following chapters have been added or have changed.

Information on reprocessing

Instructions for reprocessing are based on

internationally accepted guidelines, e.g., standard CAUTION
ISO 17664. Risk of failure of flow measurement

Safety information Improper reprocessing and soiling, such as

deposits or particles, can damage the flow
WARNING sensor.
– No machine cleaning or disinfection
Risk due to inappropriately reprocessed – No plasma sterilization or radiation
products sterilization
– No water jets, compressed air, brushes or the
Reusable products must be reprocessed, like
otherwise there is an increased risk of – No ultrasonic bath
infection. – No hot-steam sterilization with Spirolog and
– Follow the infection prevention policies Infinity ID flow sensors
and reprocessing regulations of the – Clean and disinfect the flow sensor in
health-care facility. accordance with the corresponding
– Follow the national infection prevention instructions for use.
policies and reprocessing regulations. – For disinfecting the flow sensor use only
– Use validated procedures for clean disinfectant solutions.
reprocessing.
– Reprocess reusable products after every
use. WARNING
– Follow the manufacturer's instructions for
cleaning agents, disinfectants, and Risk of fire
reprocessing devices. Residual vapors of easily flammable
disinfectants (e.g., alcohols) and deposits
CAUTION that were not removed during reprocessing
can ignite when the flow sensor is in use.
Risk due to faulty products – Ensure particle-free cleaning and
disinfection.
Signs of wear, e.g., cracks, deformation, – After disinfection, allow the flow sensor to
discoloration, or peeling, may occur with air for at least 30 minutes.
reprocessed products. – Before inserting the flow sensor, check for
Check the products for signs of wear and replace visible damage and soiling such as
them if necessary. residual mucus, medication aerosols, and
particles.
– Replace flow sensors when damaged,
soiled, or not particle-free.

28 Supplement Fabius plus XL SW 3.n

 Reprocessing

The following safety information has been deleted:

WARNING
Risk of device failure
If the control areas located in the valve plate
are not sufficiently dried, this may
compromise the device function or may lead
to failure of the medical device.
After cleaning, the breathing system must be
sterilized with steam until it is completely dry.

Classifications for reprocessing

Classification of medical devices

Medical devices and their components are
classified according to the way they are used and
the resulting risk.

Classifica- Explanation
tion
Non-critical Components that come only into
contact with skin that is intact
Semi-critical Components that carry breathing
gas or come into contact with
mucous membranes or pathologi-
cally altered skin
Critical Components that penetrate skin or
mucous membranes or come into
contact with blood

Supplement Fabius plus XL SW 3.n 29

Reprocessing

Classification of device-specific components

Observe the instructions for use for the Surfaces which are touched less frequently:
components. – Network cables and data cables
The following classification is a recommendation – Compressed gas hoses
from Dräger. – Pressure reducers
Non-critical – Gas cylinders
Control elements and device surfaces including: – Drawer surfaces, outside and inside
– Screen – Anesthetic gas receiving system
– Softkeys – Lamp
– Rotary knob – Holder for sample line
– O2 flush key
Semi-critical
– Flow control valves
– Breathing system:
– APL valve
– Breathing system housing
– O2 sensor housing
– Inspiratory/expiratory ports, APL valve
– Writing tray
– Inspiratory valve, expiratory valve
– Grip bar on trolley
– Bag elbow
– Drawer handles
– Rigid arm for breathing bag (optional)
– Standard rails on both sides
– Flexible arm for breathing bag (optional)
– Clic adapter, Clic absorber
– Breathing hoses
– Circuit plug on the bag elbow
– Absorber container and absorber insert
– External FGO changeover switch and external
FGO port – Soda lime dust filter (optional)
– Sample line
Other surfaces which are frequently touched:
– When the sample line is fitted to the filter on
– Side parts of the housings of the screen and of the Y-piece.
other patient monitors
– When the sample line is fitted directly to the
– Accessory parts: Y-piece and the filters are fitted on the
– Storage trays breathing system
– Shelf – Ventilator lid
– Hinged arms – Ventilator membrane
– Probes of compressed gas hoses – Ventilator hose
– Mains plug – Flow sensor
– Gas cylinder valves Critical
– Transfer hose of the anesthetic gas
receiving system The device does not contain any components
classified as critical.
– Cables and hoses that lie on floor
– Brake

30 Supplement Fabius plus XL SW 3.n

 Reprocessing

Reprocessing list

Components Surface disinfec- Manual cleaning fol- Machine clean- Steam steriliza-
tion with cleaning lowed by disinfec- ing with thermal tion
tion by immersion disinfection
Device surfaces Yes No No No
Breathing system Yes Yes Yes Yes
housing
Ports No Yes Yes Yes
APL valve Yes (exterior) Yes Yes Yes
Inspiratory valve, No Yes Yes Yes
expiratory valve
Bag elbow Yes Yes Yes Yes
Rigid arm for Yes Yes Yes Yes
breathing bag
(optional)
Flexible arm for Yes Yes Yes Yes
breathing bag
(optional)
Absorber con- No Yes Yes Yes
tainer and
absorber insert
Clic adapter Yes Yes Yes Yes
(option)
Ventilator lid Yes No Yes Yes
Ventilator mem- No No Yes Yes
brane

Supplement Fabius plus XL SW 3.n 31

Reprocessing

Reprocessing procedures

Validated reprocessing procedures

At the time of product-specific validation, the
following reprocessing procedures showed good
material compatibility and effectiveness:

Procedure Agent Manufacturer Concentra- Contact Tempera-

tion time ture
Surface disinfection with Incidin Extra N Ecolab – – –
cleaning
Incidur Ecolab – – –
Manual cleaning Neodisher FA, Dr. Weigert – – –
Neodisher Medi- Dr. Weigert – – –
zym
Disinfection by immersion Korsolex extra Bode Chemie – – –
Gigasept FF Schülke & Mayr – – –
Machine cleaning Neodisher FA, Dr. Weigert – – –
Neodisher Medi- Dr. Weigert – – –
zym
Machine disinfection – – – 10 min 93 °C
(thermal) (199.4 °F)
Steam sterilization – – – 5 min 134 °C
(273.2 °F)

Disinfectants
Use disinfectants that are nationally approved and
are suitable for the particular reprocessing
procedure.

Surface disinfectants
At the time of the test, the surface disinfectants Observe the specifications of the surface
listed in the following table showed good material disinfectant manufacturers.
compatibility. They can be used in addition to the
Other surface disinfectants are used at one's own
surface disinfectants listed in the section
risk.
"Validated reprocessing procedures".
The manufacturers of the surface disinfectants
have verified at least the following spectra of
activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses

32 Supplement Fabius plus XL SW 3.n

 Reprocessing

Class of active ingredient Surface disinfectants Manufacturer

Chlorine-releasing agents Actichlor plus Ecolab
BruTab 6S Brulin
Clorox Professional Disinfecting Clorox
Bleach Cleaner
Dispatch Hospital Cleaner Disin-
fectant Towels with Bleach
Klorsept 17 Medentech
Oxygen-releasing agents Descogen Liquid Antiseptica
Descogen Liquid r.f.u.
Oxygenon Liquid r.f.u.
Dismozon plus Bode Chemie
Dismozon pur1)
Oxycide Ecolab USA
Perform Schülke & Mayr
Virkon DuPont
SteriMax Wipes Maxi Aseptix
Quaternary ammonium com- Mikrozid sensitive liquid2) Schülke & Mayr
pounds
Mikrozid sensitive wipes2)
Mikrozid alcohol free liquid2)
Mikrozid alcohol free wipes2)
acryl-des2)
Cleanisept Wipes Maxi Dr. Schumacher
Surfa'Safe Premium ANIOS Laboratories
Wip'Anios Excel
Tuffie 5 Vernacare
Aldehydes Buraton 10 F1) Schülke & Mayr

1) Discontinued by the manufacturer

2) Virucidal against enveloped viruses

Dräger states that oxygen-releasing agents and

chlorine-releasing agents may cause color change
in some materials. Color change does not indicate
that the product is not functioning correctly.

Supplement Fabius plus XL SW 3.n 33

Reprocessing

Disinfectants 5 Check the product for visible damage and

replace if necessary.
Use disinfectants that are nationally approved and
are suitable for the particular reprocessing Disinfection by immersion
procedure.
1 Prepare the disinfectant solution in accordance
with the manufacturer's instructions.
Surface disinfection with cleaning
2 Swirl the product backwards and forwards
WARNING several times in the solution. Make sure that
the solution reaches all surfaces and interior
Risk due to penetrating liquid spaces.
Penetrating liquid may cause the following: 3 After the contact time has elapsed, rinse the
product with water (at least drinking-water
– Damage to the device quality) until residual disinfectant is no longer
– Electric shock discernible.
– Device malfunctions 4 Check the product for visible damage and
replace if necessary.
Ensure that no liquid penetrates the device.
5 Thoroughly shake out residual water. Allow the
1 Remove soiling immediately. Use a cloth product to dry completely.
dampened with disinfectant to remove soiling.
2 Perform surface disinfection.
Machine cleaning with thermal
disinfection
3 After the product has been exposed to the
disinfectant for the specified contact time, Use a washer-disinfector that meets the
remove residual disinfectant. requirements of the standard ISO 15883. Dräger
4 Wipe with a cloth dampened with water (at recommends the use of a cart for anesthesia
least drinking-water quality). Allow the product accessories and ventilation accessories.
to dry. 1 Securely position the product in the basket.
5 Check the product for visible soiling. Repeat Ensure the following:
steps 1 to 5 if necessary. – All surfaces and interior spaces can be
6 Check the product for visible damage and flushed completely.
replace if necessary. – The water can drain off freely.
2 Use a suitable cleaning agent.
Manual cleaning followed by 3 Select a suitable cycle. Use demineralized
disinfection by immersion water for the final rinsing.
Manual cleaning 4 After the cycle has ended, check the product
The cleaning agent that is used must have a pH of for visible soiling. If necessary, repeat the cycle
between 9 and 12. or perform manual cleaning and disinfection by
immersion.
1 Prepare the cleaning solution in accordance
with the manufacturer's instructions. 5 Check the product for visible damage and
replace if necessary.
2 Swirl the product backwards and forwards
several times in the solution. Make sure that 6 Allow the product to dry completely.
the solution reaches all surfaces and interior
spaces.
3 Rinse the product with water (at least drinking-
water quality) until residual cleaning agent is no
longer discernible.
4 Check the product for visible soiling. Repeat
steps 1 to 4 if necessary.

34 Supplement Fabius plus XL SW 3.n

 Maintenance

Steam sterilization
Use a steam sterilizer that meets the requirements
of the standard ISO 17665. Dräger recommends
steam sterilization with fractionated vacuum.
Prerequisite: The product has been cleaned and
disinfected.
1 Sterilize the product.
2 Check the product for visible damage and
replace if necessary.

Maintenance

Inspection

The following table has changed:

Inspections must be carried out regularly

according to the following guidelines and within the
specified intervals. Technical documentation is
available on request.

Checks Interval Responsible personnel

Inspection and safety checks1) Every 12 months Service personnel

1) Designation applies to the Federal Republic of Germany; corresponds to the “Recurring safety inspection” in the Federal
Republic of Austria

Safety checks
An additional check point has been added to "Check safety
features".

6 Check safety features:

– Check the functional state of the optical
and acoustic alarm generators.
– Check the functional state of the O2 failure
alarm.
– Check the locking device of the anesthetic
vaporizer.
– Check the function of the power failure
alarm and the battery function.
– Check the operation of the battery failure
alarm.
– Check S-ORC functionality.

Supplement Fabius plus XL SW 3.n 35

Maintenance

Maintenance

The following safety information has been added:

NOTE
Only perform maintenance measures if there is
no patient connected to the device.

The following table has been amended:

The following table shows the maintenance

intervals:

Component Interval Measure Responsible personnel

CO2 absorber If colored violet Replace User
Water trap As needed or if Replace User
soiled
Flow sensor As needed or if Clean/replace User
calibration is no
longer possible.
O2 sensor As needed, if cali- Replace User
bration is no lon-
ger possible, or if
the O2 SENSOR
FAIL ! message is
displayed.
Internal lithium battery Every 36 months Replace Experts
Lead-gel battery Every 3 years Replace Experts
Cylinder pressure reducer for After 6 years Basic overhauling Experts
high-pressure cylinders1)
Pressure reducer for PIN After 6 years Replace Experts
index1)
1) optional

36 Supplement Fabius plus XL SW 3.n

 Technical data

Technical data

General information

The following text has changed: All patient-related fresh-gas flow values are
normalized to STPD conditions.
All patient-related volume values are normalized to
STAPD conditions.

Ambient conditions

The unit "psi" for ambient pressure has been added.

During operation
Temperature 10 to 35 °C (50 to 95 °F)
Ambient pressure 700 to 1060 cmH2O (hPa) (10.9 to 15.9 psi)
Relative humidity 20 to 80 % (without condensation)
Height Up to 3000 m (9843 ft)

During storage and transport

Temperature -10 to 60 °C (14 to 140 °F)
Ambient pressure 700 to 1060 cmH2O (hPa) (10.9 to 15.9 psi)
Relative humidity 10 to 90 % (without condensation)

The conditions for use when using additional devices can limit the environment of use of a system as a
whole. Vaporizers and anesthetic agents can limit the use of an anesthesia workstation with regard to its
temperature range and maximum fresh-gas flow. Therefore when using additional devices, follow the
associated instructions for use.

Supplement Fabius plus XL SW 3.n 37

Technical data

Device data

The following data have been added:

Medical gas supply through central gas supply

Average inlet flow at 2.8 kPa x 100 (40.6 psi) supply ≤

pressure 60 L/min

Power supply

Inrush current approx. 25 to 50 A peak

The part number of the instructions for use for the power socket strip has been deleted:

The power rating cannot be configured, with optional

Dräger power socket strip (see instructions for use
for power socket strip for medical devices)

External fresh-gas outlet

The data for the fresh gas flow have been deleted:

Fresh-gas flow 0 and 0.2 to 18 L/min

General safety standards for anesthesia workstations

The following sentence has been deleted: The following also apply for devices manufactured
from July 2014 on:

Ventilator

The accuracy of the tidal volume has been changed:

Accuracy
Tidal volume (VT) ±5 % of the set value or 20 mL, whichever value
is higher

38 Supplement Fabius plus XL SW 3.n

 Technical data

Vaporizer interface

The data for the PAW, MVe, and VTe parameters in the
following table have changed.

Measured value or Range Resolution Accuracy Condition

waveform
PAW Airway pressure -20 to 99 cmH2O 1 cmH2O ±4 %1)
(numeric) (hPa) (hPa)
Airway pressure 0 to 99 cmH2O
(waveform) (hPa)
Pressure gauge -20 to 80 cmH2O 5 cmH2O ±(2 % of scale value +
(mechanical) (hPa) (hPa) 4 % of displayed
value)
MVe Expiratory minute 1 to 32.0 L/min 0.1 L/min ±15 % or ±0.2 L/min,
volume depending on which
value is higher
<1 L/min 0.1 L/min ±(20 mL x respiratory
rate) or ±0.2 L/min,
depending on which
value is higher
VTe Expiratory tidal 100 to 1500 mL 1 mL ±15 %
volume
<100 mL 1 mL ±20 mL

Note: If the endtidal desflurane concentration increases to above 12 %, the measurement accuracy of
the tidal volume and minute volume can deviate by more than 15%.
Freq Respiratory rate 2 to 99 bpm ±1 bpm ±1 bpm (±1 1/min) of
(1/min) (1/min) the setting or ±5%,
depending on which
value is higher
FiO2 O2 measurement 10 to 100 Vol% 1 Vol% ±2.5 Vol% +2.5 % of Based on the
in the mainstream the measured values ambient pressure
in accordance with during calibration
ISO 21647 and
ISO 80601-2-55
1) Max. ±4 % of the measured value or ±2 cmH2O (±2 hPa), depending on which value is higher.

Supplement Fabius plus XL SW 3.n 39

Technical data

The data for the O2 sensor have been added.

O2 sensor
(Electrochemical cell with perma-
nent measured value generation)
Response time (T90) Less than 16 seconds Measured values are not pressure
compensated.
Heat-up time after 5 minutes Error with
≤
3 % of the measured value
Drift sensitivity ±1 % of the measured value/ 8 h
Cross sensitivity 1 Vol% O2 at 70 Vol% N2O and 5 Vol%
CO2
With 4 Vol% halothane
or with 5 Vol% enflurane
or with 15 Vol% desflurane
or with 5 Vol% isoflurane
or with 10 Vol% sevoflurane
Measurement deviation due to Max. ±0.02 % of the measured value per % relative humidity
humidity
No demonstrable quantitative effect on the gas measurement due to ambient conditions.
Maximum period of use of O2 >12 months at 25 °C (77 °F), 50 % relative humidity, 50 % O2 in fresh
sensor cell gas (or >5000 hours at 100 Vol% O2)

40 Supplement Fabius plus XL SW 3.n

 Technical data

Breathing system

The following data have been added:

Compliance
including ventilator hose (without breathing 0.8 mL/cmH2O (0.8 mL/hPa) at 30 hPa
hoses)

Flexible arm for breathing bag (optional)

Volume 0.13 L
Compliance 0.13 mL/cmH2O (0.13 mL/hPa) at 30 hPa

Rigid arm for breathing bag (optional)

Volume 0.11 L
Compliance 0.11 mL/cmH2O (0.11 mL/hPa) at 30 hPa

Resistance
Peak flow Resistance
[L/min] [cmH2O (hPa)]
Inspiratory Expiratory
In accordance with ISO 80601-2-13, dry, with 60 -4.7 4.4
adult breathing hose set M301461) 30 -0.6 4.2
15 0.4 3.4
In accordance with ISO 80601-2-13, dry, with neo- 2.5 1.0 2.9
natal breathing hose set M336811)
In accordance with ISO 80601-2-13, dry, without 60 -3.7 3.7
hoses1)

1) Depending on the ventilation settings, the indicated values may deviate by ±0.3 cmH2O (0.3 hPa).

Alarm for low oxygen supply pressure

The alarm limit has changed:

Alarm limit Warning signal (continuous tone for 10 seconds,

adjustable from approx. 61 dB(A) to 74 dB(A)), as
soon as the pressure drops below 20 ±6 psi (1.35
±0.4 kPa x 100).

Supplement Fabius plus XL SW 3.n 41

Technical data

EMC declaration

The following chapters have changed: Electromagnetic environment

This device may only be used in environments
General information
specified in the instructions for use under
This device was tested for electromagnetic "Environments of use" in the chapter "Application".
compatibility using accessories from the list of
accessories. Other accessories may only be used Emissions Compliance
if they do not compromise the electromagnetic Radiated emis- Class A, group 1 (30 MHz to
compatibility. The use of non-compliant sions 1 GHz)
accessories may result in increased
electromagnetic emissions or decreased Conducted emis- Class A, group 1 (150 kHz to
electromagnetic immunity of the device. sions 30 MHz)
This device may be used in the direct vicinity of
other devices only if Dräger has approved this NOTE
device arrangement. If no approval has been given
The emissions characteristics of this equipment
by Dräger, it must be ensured that this device
make it suitable for use in industrial areas and
functions correctly in the desired arrangement
hospitals (CISPR 11 class A). If it is used in a
before use. The instructions for use for the other
residential environment (for which CISPR 11
devices must be followed.
class B is normally required), this equipment
might not offer adequate protection to radio-
Electromagnetic emissions frequency communication services.
The chapter has been deleted. The user might need to take mitigation
measures, such as relocating or re-orienting the
equipment.

42 Supplement Fabius plus XL SW 3.n

 Annex

Immunity against Test level and required electromagnetic environ-

ment
Electrostatic discharge (ESD) Contact discharge: ±8 kV
(IEC 61000-4-2)
Air discharge: ±15 kV
Fast transient electrical disturbances (bursts) Power cable: ±2 kV
(IEC 61000-4-4)
Longer signal input lines/output lines: ±1 kV
Impulse voltages (surges) Voltage, external conductor – external conductor:
(IEC 61000-4-5) ±1 kV
Voltage, external conductor – protective ground con-
ductor: ±2 kV
Magnetic fields at mains frequency 50 Hz: 30 A/m
(IEC 61000-4-8)
Voltage dips and short interruptions in the sup- Voltage dips of 30 % to 100 %, 8.3 ms to 5 s, different
ply voltage phase angles
(IEC 61000-4-11)
Radiated high-frequency disturbances 80 MHz to 2.7 GHz: 3 V/m
(IEC 61000-4-3)
Conducted high-frequency disturbances 150 kHz to 80 MHz: 3 V, ISM bands: 6 V
(IEC 61000-4-6)
Electromagnetic fields in the vicinity of wireless Various frequencies from 385 MHz to 5785 MHz:
communication devices 9 V/m to 28 V/m

Recommended separation distances

from wireless communication devices
To ensure that the full functional integrity of this
device is not compromised, there must be a
separation distance of at least 1.0 m (3.3 ft)
between this device and wireless high-frequency
communication equipment.

Annex

Form for daily checkout and pre-use checkout

The terminology for the O2 sensor has changed.

Start the calibration.
Calibration of the sensors Insert the O2 sensor back in the cover of
Remove the O2 sensor from the cover of the inspiratory valve.
the inspiratory valve. Calibrate the flow sensor.
Expose the O2 sensor to ambient air for
2 minutes.

Supplement Fabius plus XL SW 3.n 43

 Manufacturer

Drägerwerk AG & Co. KGaA

Moislinger Allee 53 – 55
D-23542 Lübeck
Germany
+49 451 8 82-0
FAX +49 451 8 82-2080
http://www.draeger.com

9055595 – en

Á9055595|È
© Drägerwerk AG & Co. KGaA
Edition: 3 – 2018-07
(Edition: 1 – 2017-01)
Dräger reserves the right to make modifications
to the medical device without prior notice.
ision]_0000046414_No.0512