Dräger Fabius Series User manual

Drägerwerk AG & Co. KGaA, 23542 Lübeck
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck, Germany
Postal address:
23542 Lübeck, Germany
Tel [phone]
Fax [phone]
[e-mail]
www.draeger.com
VAT no. DE135082211
Bank details:
Commerzbank AG, Lübeck
IBAN: DE95 2304 0022 0014 6795 00
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Sparkasse zu Lübeck
IBAN: DE15 2305 0101 0001 0711 17
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Registered office: Lübeck
Commercial register:
Local court Lübeck HRB 7903 HL
General partner: Drägerwerk Verwaltungs AG
Registered office: Lübeck
Commercial register:
Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board
for Drägerwerk AG & Co. KGaA and
Drägerwerk Verwaltungs AG:
Stefan Lauer
Executive Board:
Stefan Dräger (chairman)
Rainer Klug
Gert-Hartwig Lescow
Dr. Reiner Piske
Anton Schrofner
To Dräger Customers and
Health Care Professionals
in the United States of America
April 24th 2020
COVID-19: Usage of Dräger anesthesia devices for long-term ventilation Rev. 5
Dear Customers and Health Care Professionals,
The World Health Organization (WHO) declared COVID-19 a pandemic on March 11th, 2020 with currently
over 2,600,000 confirmed cases of the coronavirus illness reported in over 180 countries worldwide. The
pandemic has created a high demand for mechanical ventilation that may exceed the number of available ICU
ventilators in hospitals treating patients with the disease. In the last few days, many customers and healthcare
professionals have approached us to obtain information about possibly using Dräger anesthesia devices for
long-term ventilation as an alternative ventilator for ICU patients when existing devices are fully utilized and
there is no other ventilator option.
Our reference
COVID-19 –Draeger, Inc
Phone
1-800-4-DRAGER
E-mail
remosaus @draeger.com
Please visit the Dräger COVID-19 website
https://www.draeger.com/en-
us_us/Home/novel-coronavirus-outbreak
for updates and other useful information

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Under these special circumstances, we believe it is our responsibility to provide some insights both (i) on the
legal and regulatory perspective as well as (ii) on some known limitations of Dräger anesthesia devices for
long-term ventilation.
If you have any questions or comments, please do not hesitate to contact your local Dräger
representative. As mentioned, feedback is highly appreciated and enables us to share new information
about this subject with medical caregivers worldwide.
With kind regards,
Ines Thams Ralf Heesch Moritz Rahlf-Luong
Risk Manager System Engineer Product Management Anesthesiology

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Index
Legal and regulatory perspective ........................................................................................................5
Known limitations of Dräger anesthesia devices regarding use in long-term ventilation .............6
1General instructions...................................................................................................................6
2Prerequisites & preparation.......................................................................................................6
2.1 Training of medical personnel .................................................................................................6
2.2 Location requirements.............................................................................................................7
2.3 Manual resuscitator .................................................................................................................7
2.4 Oxygen backup cylinder ..........................................................................................................8
2.5 Evacuation of gases (Scavenging)..........................................................................................8
2.6 Disconnection of vaporizers & N2O .........................................................................................8
2.7 Infection prevention .................................................................................................................9
2.8 Filters & humidification ............................................................................................................9
2.9 Breathing bag ........................................................................................................................11
2.10 Water Trap - Waterlock 2 ......................................................................................................11
2.11 CO2 absorber.........................................................................................................................11
2.12 System configuration / default settings..................................................................................12
3Regular checks .........................................................................................................................13
3.1 System Test...........................................................................................................................13
3.2 System restart & refreshing internal memory ........................................................................14
3.3 Check for overall status and accessories..............................................................................14
4Therapy......................................................................................................................................15
4.1 Fresh gas flow .......................................................................................................................15
4.1.1 General recommendation –high fresh gas flow............................................................... 15
4.1.2 Additional fresh gas flow................................................................................................... 15
4.1.3 Reduced fresh gas flow.................................................................................................... 15
4.2 Handling leakages.................................................................................................................17
4.3 Modes of operation................................................................................................................17
4.3.1 Ventilation mode - Man / Spon ......................................................................................... 17
4.3.2 Discouraged use –external Fresh Gas Outlet, Pause, and Monitoring mode.................. 18
4.4 Alarm volume 100% ..............................................................................................................18

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4.5 Patient-specific limits for all alarms .......................................................................................18
4.6 Alarm notifications.................................................................................................................19
4.7 Gas measurement.................................................................................................................19
4.7.1 FiO2................................................................................................................................... 19
4.8 Endotracheal suctioning in a closed system..........................................................................19
4.9 Nebulization of drugs and aerosol therapy............................................................................20
4.10 In case of failure ....................................................................................................................20
5Consumption of fresh gas and soda lime ..............................................................................20
6Oxygen concentrator “O2 93” ..................................................................................................21
7Direct injection of volatile agents at Y-piece (not recommended).......................................21
8Ventilating multiple patients with one device (not recommended)......................................21
9Attachments..............................................................................................................................22
9.1 Attachment 1: Comments on particular modes of operation .................................................23
9.2 Attachment 2: Overview of Ventilation Modes.......................................................................24
9.3 Attachment 3: Dräger Fabius Family with Installed Fresh Gas Outlet (FGO)........................26
9.4 Attachment 4 –Active Gas Scavenging (AGS) alternatives..................................................27
9.5 Attachment 5: Increasing fresh gas flow by opening the emergency O2 flow control...........27
9.6 Attachment 6: Fresh gas settings..........................................................................................28
9.7 Attachment 7: Decision support in case of supply shortages................................................29

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Legal and regulatory perspective
The intended use of each Dräger anesthesia device is described in the relevant instructions for use.
Although the wording of the intended use may vary among the devices, the content is very similar: The
devices are specified for use during surgical or diagnostic interventions under the constant supervision
of the user(s).
Any use of the device outside of the intended use specified in the instructions for use (e.g. long-
term ventilation) constitutes off-label use.
If a device is used off-label, the user recognizes that it is not the intended use of the device and does so
at their own responsibility and at his own (liability) risk. However, in a situation in which a patient requires
long-term mechanical ventilation but cannot be ventilated due to a lack of intensive care ventilators, the
benefit of being able to ventilate such a patient with a Dräger anesthesia device has to be weighed
against the risk of the off-label usage of a Dräger anesthesia device. This risk benefit assessment and
the resulting decision have to be made by the responsible health care professional, based on the
circumstances of the particular case.
WARNING: The following information on the legal and regulatory perspective is limited to the
laws in force in the European Union (EU) as of the date of this letter and provides only general
guidance. Please contact your legal counsel for guidance on your particular case.

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Known limitations of Dräger anesthesia devices regarding use in long-term
ventilation
WARNING: The following information is based on our currently available knowledge as of the
date of this letter. It only applies to Dräger anesthesia devices still being marketed. It is most
likely not complete or exhaustive. If you detect important points that are missing, please let us
know.
WARNING: Dräger as the manufacturer cannot and is not allowed to market or promote or sign-
off such off-label use of Dräger anesthesia devices. The following information is therefore
provided only to give the responsible health care professional a better basis for decision-making.
If a device is used off-label, the user does so under their own responsibility and at their own
(liability) risk.
1 General instructions
The following proposals support the targets that the off-label-use is as safe as possible, and that as many
anesthesia devices as possible will maintain their ventilation capacities, even under long-term ventilation.
Refer to the following website https://www.draeger.com/en-us_us/Home/novel-coronavirus-outbreak for
an additional check list that you may provide at every workplace. Please be aware, that this
customer letter is more detailed and prevails over the additional check list.
2 Prerequisites & preparation
2.1 Training of medical personnel
-Anesthesia devices have a different working principle and different user interface (e.g. different
operating modes) than intensive care ventilators. Therefore, medical personnel using the
device must be well trained and familiar with the unique performance characteristics of
the devices.

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- Before connecting a patient, the user must be able to check the proper device status, ensure
that all accessories (e.g. ventilation hoses, bacteria filter, gas sampling line, manual breathing
bag, water traps) are properly connected and that the device is able to generate gas flow and
pressure at the patient connector. With the exception of Australia and New Zealand, the
connectors for the manual breathing bag and ventilation hoses have the same diameter.
Therefore, the risk of incorrectly connected patient hoses is given. A false connection (e.g. bag
hose connected to inspiratory port) would make the ventilation of the patient impossible. As a
result, particularly when connecting a patient to an anesthesia device, the user requires
device knowledge and clinical experience with anesthesia devices. Directly before
connecting the patient, the user has to check if the device is able to deliver pressure to the
patient connector and that by unblocking the patient connector the pressure can be released
and gas can flow out (see e.g. website of European Patient Safety Foundation:
https://www.eupsf.org/safety-alert-wrong-tube-connections)
2.2 Location requirements
- Anesthesia devices should be used only in rooms with adequate ventilation.
- The user interface of Dräger anesthesia devices cannot be protected against non-authorized
users. Therefore, the operating organization must ensure that non-authorized users
cannot approach the device to avoid settings being changed, or therapy being stopped (no
alarm is generated when the device is switched to standby).
2.3 Manual resuscitator
- The instructions for use state a manual resuscitator must always be available at the device
which enables back-up ventilation of the patient in case of problems or malfunctions with the
device. Particularly for users with limited knowledge of anesthesia devices, it is particularly
important that in case of irregularities or unexpected system behavior impairing patient
therapy, the patient has to be disconnected from the anesthesia device and ventilated with an
operator powered resuscitator. Due to the situation of the patient, it is recommended that you
have a manual resuscitator available that allows the application of a PEEP.

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2.4 Oxygen backup cylinder
- In case of shortages or loss of central gas supply, Dräger anesthesia devices will continue with
mechanical ventilation. Shortages will lead to alarms of the anesthesia, please refer to the
instructions for use and check under the chapter “Fault - Cause - Remedy”. To ensure the
desired FiO2 level, an O2 backup cylinder is required. For connection, check the instructions
for use. If both sources of oxygen (central gas supply and backup cylinders) are depleted, the
hand bag (incl. the hose between the hand bag and the breathing system, or the flexible bag
arm) has to be disconnected from the breathing system. The anesthesia device will continue
ventilation with ambient air (21% FiO2 and no volatile agents can be applied), because of the
electrically driven ventilators.
2.5 Evacuation of gases (Scavenging)
- To avoid oxygen accumulation in the direct environment of the device, a proper
scavenging is recommended although no anesthetic agent is used. For more information
see Attachment 4 –Active Gas Scavenging (AGS) alternatives
2.6 Disconnection of vaporizers & N2O
- In order to prevent the use of anesthetic agents in a situation that might harm the patient or the
patient’s environment, it is recommended that you disconnect all vaporizers from the
anesthesia device and store them in the operation room. This is particularly important because
even very small concentrations of volatile agents may trigger malignant hyperthermia
(e.g. of the clinician or the patient).
- The fresh gas flow must only contain a mix of oxygen and medical air. The use of nitrous-oxide
(N2O) during long-term ventilation must be prevented as users with no anesthesia experience
are possibly not familiar with the fact that a decrease of the oxygen concentration in the fresh
gas flow would increase the N2O concentration in the inspiratory gas. Therefore, it has to be
ensured that no N2O hose and no N2O cylinder are connected to the anesthesia device.
Furthermore, in Dräger anesthesia devices with an electronic gas mixer (Perseus A500 with
electronic gas mixer) usage without N2O has to be configured in the system configuration.

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2.7 Infection prevention
- Regarding infection prevention, hospital guidelines have to be followed. This includes the
reprocessing of the device after usage on infectious patients (particularly the device surfaces)
but also the adequate use of bacteria filters. More information regarding infection prevention in
the context of COVID-19 is provided in the Dräger 2019-nCoV infection prevention customer
letters for anesthesia and intensive care and their supplements, please refer to the following
website: https://www.draeger.com/en-us_us/Home/novel-coronavirus-outbreak
2.8 Filters & humidification
- Only mechanical filters are suitable in long-term ventilation because with electrostatic
filters, the filtering performance is reduced when they become too humid. The use of mechanical
filters also ensures that the excess gas or gas that leaves the breathing system when the hand
bag is detached will not be contaminated.

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- Two different solutions for the use of mechanical filters are recommended:
oSolution 1 –Passive humidification
Use of a combined element: Heat and Moisture Exchanger (HME) / mechanical
breathing system filter (e.g. Dräger TwinStar HEPA)
Location: only at the patient connector (Y-piece)
oSolution 2 –Active humidification
In combination with active humidification, use two mechanical filters without
HME (e.g. Dräger SafeStar filter series).
Location: at the inspiratory AND the expiratory ports of the anesthesia device
Please consider the following information regarding active humidification in
combination with anesthesia devices.
If possible from a clinical perspective, use HME / mechanical breathing system filters at the Y-
piece (solution 1) with Dräger anesthesia devices.
- The use of active humidification is not approved with Dräger anesthesia devices If, however,
an active humidifier is used in this exceptional situation, rebreathed humid gas must not create
excessive condensation in the breathing system of the anesthesia device. Breathing circuits
require a water trap in the expiratory limb. Dual heated breathing circuits must not be
used with Dräger anesthesia devices. Also, the use of filters or even HME/filters at the Y-piece
must be avoided to prevent excessive breathing resistance due to clogged filters resp.
HME/filters during active humidification. When using a filter at the expiratory port, the resistance
can potentially exceed values demanded by the ISO 80601-2-13:2011 standard. Close
monitoring of the respective ventilation, e.g. particularly narrow limits for the minute volume low
alarm and vital parameters, are compulsory. Additionally, a filter must be used on the inspiratory
port of the anesthesia device. As mentioned before, only mechanical filters shall be used. A
high fresh gas flow of at least 150% of the minute volume helps avoid excessive
condensation in the breathing system as well as at the filter at the inspiratory port. For
the reprocessing of the anesthesia device after each patient follow the recommendations for
anesthesia devices potentially contaminated with SARS CoV-2.

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2.9 Breathing bag
- The breathing bag of Dräger anesthesia devices acts as a reservoir during mechanical
ventilation. The exhaled breathing gas is captured in the breathing bag. Therefore, the breathing
bag moves during mechanical ventilation. The capacity of the breathing bag should always
be sufficient. A high fresh gas flow increases the robustness of the ventilation. When the fresh
gas flow is too low, the manual breathing bag (reservoir for the patient gas) may collapse in a
leakage situation, which would impair the ventilation. In particular, patients breathing
spontaneously might require very high tidal volumes, which they inhale from the manual
breathing bag. Using a very large breathing bag (e.g. Dräger 3 liter breathing bag) is
recommended to avoid having the breathing bag limit the spontaneous breath of the patient.
2.10 Water Trap - Waterlock 2
- The water trap (Waterlock2) at the gas measurement module of Dräger anesthesia devices
protects the gas measurement against humidity. To ensure system functionality the water
trap has to be emptied or exchanged before it becomes full. Please refer to the IFU for how
to drain the water trap. The required frequency of doing this depends on the humidity of the
sample gas. For usage of the Dräger anesthesia device with high fresh gas flows and a
combined HME/ mechanical filter we expect that the filling level has to be checked every 12
hours. If using the recommended filter on the Y-piece (combined Heat and Moisture Exchanger
(HME) / mechanical breathing system filter (HMEF) or a mechanical breathing system filter) and
the gas sampling line is connected on the device side of the filter, the water trap has to be
exchanged at least every 4 weeks. If no mechanical filter or HMEF is used on the Y-piece or the
gas sampling line is connected on the patient side of the filter, exchange the water trap at least
every 7 days.
2.11 CO2 absorber
- One significant difference between intensive care ventilators and anesthesia devices is that
anesthesia ventilators are based on a rebreathing system and adjustable fresh gas flows. This
requires the use of a CO2absorber to prevent high CO2levels in the circuit. It is important to
examine the CO2absorber and change it before it is exhausted. An exhausted absorber can be

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detected by an increasing inspiratory CO2measurement or a change in color (purple) of the
Dräger CO2absorber (see instructions for use of anesthesia device and CO2-absorber for more
information). Generally the absorber will absorb CO2and thus change color from the
bottom to the top. Due to the fact that high fresh gas flows dry out the CO2absorber there
might be a color change from the top to the bottom of the absorber. This does not impact
the absorption capability of the soda lime and does not pose any risk to the patient
because no volatile agents must be used. An exchange of the absorber is not required in
this case. The activation of an inspiratory CO2high alarm limit helps to directly inform the
user about an exhausted absorber.
- The anesthesia device should never be operated without a CO2absorber, except when
changing a used absorber. The permanent use of a CO2absorber ensures that the patient
does not inhale inspiratory CO2even in the case of error –such as problems with the fresh gas
supply and/or delivery. By using high fresh gas flows of at least 150% of the minute volume of
the patient, there will only be limited rebreathing and therefore the absorber will last a longer
time. Nevertheless, the absorber should be changed every 7 days, regardless of whether the
absorption capacity has been spent.
- Only use Dräger absorber due to minimal dust emission. If using Perseus A500 with a
reusable absorber please always use a fresh dust filter when exchanging the soda lime. Using
soda limes of lesser quality may cause device failures.
2.12 System configuration / default settings
- Default settings can be configured at Dräger anesthesia devices. The default settings become
automatically active when starting a new patient case, when performing a device restart or when
using a dedicated device function (e.g. in Apollo via the soft key “restore default settings”).
Particularly the following default settings should be adapted for the use in long-term ventilation:
alarm volume, alarm limits, ventilation settings (particularly Pmax in volume controlled
ventilation modes), fresh gas flow and fresh gas oxygen concentration, all alarms shall remain
active in MAN/SPON (i.e. the suppression of alarms in MAN/SPON is configured with “no”; this
setting can only be configured in Perseus and Apollo), deactivate N2O (all devices with electronic

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gas mixer), units (e.g. for etCO2), activation of alarm entries in the device logbook, and set entry
interval to ≤2 minutes (Perseus and Apollo).
- The adaption of default settings can only be done in standby and is protected by a password.
For adapting the settings, please contact the responsible person in your organization and check
the instructions for use. If further help is required, please contact your local Dräger
representative.
- WARNING: If the device configuration is not adapted for the use in long-term ventilation, the
active settings (especially the above mentioned settings) have to be checked and adapted
particularly carefully whenever a new patient case is started.
3 Regular checks
3.1 System Test
- The devices are designed to be tested every 24 hours to ensure readiness for operation. If
the device test is not done, the readiness of operation is not tested, and particularly the flow
measurement may become inaccurate. In general, never rely on a single measured value
for clinical decisions. Unlike many ICU ventilators, the flow measurement of the anesthesia
device cannot be calibrated during operation. Measured values may change their color to
indicate an inaccurate status. The accuracy of gas measurement should not be affected
because the gas measurement modules perform a zeroing during operation independently of
the system test, except the mainstream O2-sensor of the Fabius family. Please be aware that
the anesthesia devices may raise technical alarms regarding required calibrations of flow
measurement and the Fabius FiO2measurement; nevertheless these values can be used in the
case of long-term ventilation. If in doubt, perform a system test.
- Each time the anesthesia device is prepared for long-term ventilation of a new patient, perform
a complete system test (not only a leakage test).

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- To perform the system test, the patient must be disconnected from the anesthesia device.
During this time, sufficient ventilation of the patient (e.g. via the resuscitator) has to be ensured.
Because the system test takes up to 8 minutes (depending on the device type), the assistance
of an experienced user is required for this step.
- Before starting the system test for any device of the Apollo- and Fabius families, it is important
to inspect the piston membrane for condensation and remove any condensation.
- If, for clinical reasons, it is not feasible to perform a system test every 24 hours, we recommend
performing the test at least every 72 hours to reduce the likelihood of device malfunctions.
- The system test always consists of a manual part (checklist) and a (semi-) automatic part,
for which both have to be performed.
3.2 System restart & refreshing internal memory
- To prepare the software (clean internal memory components) of a Dräger anesthesia system
for long-term ventilation, we recommend that you restart (switch the device off and on again at
the user interface) the device before preparing it for a new patient.
oPerseus A500: A restart is required after 28 days, but only after switching to standby.
Starting operation again will only be possible in that situation, after a restart and system
test of the device.
oApollo: A restart is necessary to access the system test.
oFabius family: The restart procedure is part of the Fabius system test and occurs by
pressing “Run System Test”. No separate restart required.
3.3 Check for overall status and accessories
- Since Dräger anesthesia devices are not designed for long-term ventilation, the overall status
of the device and its accessories has to be checked regularly (at least every 12 hours,
ideally more frequently). In particular, the following situations have to be prevented: exhausted
CO2-absorber, full gas measurement water trap, increased water accumulation in breathing

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hoses, and excessive condensation at filters and HMEs (heat and moisture exchangers) that
may lead to increased resistance.
- If a shortage (e.g. of accessories) exists or is unavoidable, refer to Attachment 7: Decision
support in case of supply shortages.
4 Therapy
4.1 Fresh gas flow
4.1.1 General recommendation –high fresh gas flow
- To avoid having the rebreathing of the patient create excessive additional humidity in the
system, a fresh gas flow of at least 150% of the minute volume of the patient is required. If
the device has a heated breathing system, we recommend that the heating remains active for
long-term therapy. Please refer to Attachment 6: Fresh gas settings if you have questions in
regards to fresh gas settings and refer to chapter 5 for gas consumption.
4.1.2 Additional fresh gas flow
- When using Perseus A500 with electronic gas mixer the fresh gas flow can be additionally
increased by opening the emergency O2flow control. Please refer to Attachment 4 –Active
Gas Scavenging (AGS) alternativesAttachment 5: Increasing fresh gas flow by opening the
emergency O2 flow control.. This gas is added to the already set fresh gas flow of the mixer.
An alarm will occur. The priority can be reduced by resetting the alarm (only possible with some
devices).
4.1.3 Reduced fresh gas flow
- If reduced fresh gas flows are used (e.g. due to shortage of supplied gases or need for
increased humidity of the patient gas) more rebreathing will take place in the system, and
ocondensation may compromise the system functionality (up to malfunction of
ventilation)
othe consumption of soda lime will increase, see chapter 5

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ocondensation may block filters in the patient circuit (especially a filter at the inspiratory
port)
Therefore, we recommend that you:
oDo not to use a fresh gas flow less than 20% of the minute volume of the patient or
less than 1 L/min. Dealing with patients producing increased amounts of CO2(e.g.
having high fever) significantly raise the fresh gas flow (e.g. to >50% of the minute
volume).
oUse hose systems with water traps in the inspiratory and expiratory limb; the longer
the hoses, the better
oDo not use a filter at the inspiratory port of the breathing system
oAlways use a mechanical filter, if available with HME at the Y-piece. Be aware that the
filters may get clogged and have to be exchanged earlier; therefore, set close alarm
limits for minute volume low and Paw high
oPerform a system test every 24 hours if possible and empty the piston membrane
before performing the system test (Apollo, Fabius family)
oSet an alarm limit for FiO2low with adequate buffer because the difference between
the set fresh gas flow and the FiO2will increase and the system will react far slower to
modifications of the O2setting
oSet an alarm limit for inspiratory CO2high to an appropriate value
oIf required, update the default settings, refer to chapter 2.12
oCheck the following parts for humidity more regularly (at least every 4 hours)
water traps in patient hoses (drain, if condensation is detected)
water trap at the gas bench - Waterlock2 (drain, if more than 50% is filled with
condensate)
filter (exchange if increased condensation is detected)
remaining capacity of CO2absorber (exchange at least when 2/3 has changed
its color to purple to reduce condensation in the breathing system;
consumption of CO2absorber will increase significantly when lowering the
fresh gas flow)
oThe device has to be operated by a constant supervision of an operator with extensive
knowledge of a rebreathing system
The measures above are very important for keeping the installed base of ventilators in
your institution functional for the patients that need long-term ventilation.

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4.2 Handling leakages
- In general, leakages are not compensated by Dräger anesthesia devices. This has to be
considered by the user, especially during all volume controlled ventilation modes. Otherwise,
insufficient ventilation situations may occur. If leakages can’t be avoided, the Pressure Control
mode has an advantage in that it delivers the set inspiratory pressure independently of any
leakage as long as the capacity of the breathing bag is sufficient. Depending on the device type,
the PEEP level might not be maintained. In fresh gas deficit situations (leakage plus patient
uptake are higher than fresh gas flow), ventilation will be affected. Appropriate alarms like “Fresh
gas low or leakage” will appear. The immediate reaction of the operator is required (reduce
leakage, increase FG flow; add up 70 L/min O2 by pressing the O2-flush to refill the system with
pure oxygen immediately). As an alternative, disconnect the manual breathing bag to entrain
ambient air. This prevents a low fresh gas situation and increases the availability of ventilation.
In this case, the resulting inspiratory oxygen concentration will be between the set fresh gas
oxygen concentration and the 21% of the ambient air. If the fresh gas flow is high, less ambient
air is entrained and the inspiratory oxygen concentration increases.
4.3 Modes of operation
- Modes, measurement values, settings, maneuvers etc. that are possibly used with ICU
ventilators might not be available in the anesthesia devices.
4.3.1 Ventilation mode - Man / Spon
- The user has to understand the Man/Spon mode (Manual or Spontaneous Ventilation),
which is a unique ventilation mode that is not available in most intensive care ventilators. This
mode can be live-saving in case of a failure of automatic ventilation and in absence of a
resuscitator. The influence of the APL valve has to be understood as well. Users with no
anesthesia background may expect that it also limits airway pressure during mechanical
ventilation. The APL valve has no influence on mechanical ventilation. It is only active in
Man/Spon mode. In the event of a ventilator failure, Man/Spon becomes active automatically
and the fresh gas flow will make the airway pressure rise up to the APL setting. Therefore, in

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mechanical ventilation, the APL valve always has to be set to a value suitable for the
patient. When setting the APL valve to the desired PEEP level (or alternatively SPONT, which
equals zero), you prevent excessive airway pressures from being applied to the patient in the
event of a ventilator failure. For the system test, the APL valve must be set to a relatively high
value. Therefore, the user also has to actively reduce this value for mechanical ventilation.
4.3.2 Discouraged use –external Fresh Gas Outlet, Pause, and Monitoring mode
- Modes that are not known by the user (e.g. Ext. Fresh Gas Outlet or Pause) should not be used.
When using Fabius devices with an installed Fresh Gas Outlet (FGO), ensure that the FGO is
in the correct position and installed properly. See details in Attachment 3: Dräger Fabius Family
with Installed Fresh Gas Outlet9.2. Furthermore, several modes may behave differently than
in intensive care ventilators. Details are listed in the Attachment 1: Comments on particular
modes of operation.
4.4 Alarm volume 100%
- The alarm and safety systems of Dräger anesthesia devices are designed for the user to always
be within 4 meters (~13 feet) of the device. This allows the userto quickly recognize and respond
in the event of an alarm or malfunction. Thus, the alarm volume always has to be set to a
sufficiently loud level, particularly in noisy environments. The alarm distribution via serial
interface is not designed in a redundant (fail-safe) way. Therefore, remote supervision (e.g. via
a central station) is not sufficient. In situations where a user is not within direct proximity of the
device, it has to be ensured that the alarm volume is set to maximum (100%) to increase the
probability that potentially life-threatening situations are recognized in time.
4.5 Patient-specific limits for all alarms
- To enable the device to generate the necessary alarms, set patient-specific limits for all
alarms and limits may have to be changed over time to adapt to changing clinical situations.
Alarm limits for the minute volume (lower and upper limit) and the expiratory CO2(lower and
upper limit) are particularly important for generating alarms when hypo- or hyperventilation
occurs. Additionally, the alarm limit for FiO2(lower limit) has to be adjusted because FiO2cannot
be set directly.

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- In contrast to most ICU ventilators some Dräger anesthesia devices also have an adjustable
Paw low alarm limit. This alarm limit has to be set either to “automatic” / “AUTO” (if available) or
between PEEP and inspiratory pressure / plateau pressure to detect unintentionally applied
continuous airway pressures as well as intrinsic PEEP situations.
4.6 Alarm notifications
- Please be aware that in Dräger anesthesia devices, alarm notifications are automatically
removed when the alarm situation that caused the alarm is no longer valid. In general, the alarm
design of ICU ventilators is completely different in this respect. Therefore, it is recommended
that the user checks periodically the alarm history / alarm log of the anesthesia device to
see if any alarms have been generated in the absence of the user.
4.7 Gas measurement
- The gas measurement of the anesthesia device, if included in the device, always has to be
connected. Unlike many ICU ventilators, the gas measurement of anesthesia devices is a side-
stream monitoring. Therefore, the gas measurement values and waveforms have a delay of
several seconds.
4.7.1 FiO2
- The rebreathing of exhaled patient gases is a significant difference from ICU ventilators. The
oxygen concentration of the inhaled gas (measured as “FiO2”) may differ from the set oxygen
concentration in the fresh gas as the result of mixing fresh gas with rebreathed gas of the patient.
Therefore, pay special attention to FiO2values and the FiO2low-alarm limit. The difference
between the fresh gas oxygen concentration and FiO2can be reduced to a minimum by
increasing the fresh gas flow to at least 150% of the minute volume. For further help regarding
fresh gas settings please refer to Attachment 6: Fresh gas settings.
4.8 Endotracheal suctioning in a closed system
- Negative pressures by suctioning can harm the lung of the patient and impair the function of
the anesthesia device and thus may lead to failures of the ventilation system. Therefore,

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reduce the power-setting of the suction system accordingly if suctioning in a closed system
/ in-line suctioning or any other PEEP-saving suctioning procedures. If in doubt, disconnect
the anesthesia device for endotracheal suctioning (consider the loss of PEEP). Alternatively,
by disconnecting the manual breathing bag you can ensure that the bag won’t collapse due to
the suctioning. By this measure, the potential of negative pressures in the system is reduced.
Pay special attention to the fact that after the suctioning the manual breathing bag has to be
reconnected by the user.
4.9 Nebulization of drugs and aerosol therapy
- Nebulization of drugs and aerosol therapy are not approved with anesthesia devices. If
aerosol or other drugs are given to the airways, malfunctions can occur. Without a mechanical
filter between the connection port of the nebulizer and the anesthesia device, malfunctions are
very likely to occur (e.g. incorrect measurement of the gas analyzer, erroneous measurement
of expiratory flows, tidal and minute volumes). If no mechanical filter is used on the Y-piece,
disconnect the sampling gas line during nebulization and aerosol therapy.
4.10 In case of failure
- If a main component of the anesthesia device, such as the mixer, ventilator or screen shows
a failure, immediately switch to an alternative means of ventilation.
5 Consumption of fresh gas and soda lime
- Dräger anesthesia devices work with an electronically driven ventilator (piston ventilator in
Apollo and Fabius- family devices; blower ventilator in Perseus). Thus these devices do not
consume any driving gas, and the consumption of gases supplied by the central gas supply or
from cylinders equals the fresh gas flow settings. For Example, if your fresh gas setting is FG-
Flow 9 L/min and FG-O2-concentration 50%, this will lead to a consumption of approx. 5.7 L/min
AIR and 3.3 L/min O2. Please note that when using active scavenging (AGS) the consumption of
centrally supplied gases will be higher.