Maquet Servo User Manual
x
User's Manual
SERVO-air Ventilator System v2.1
TABLE OF CONTENTS
| TABLE OF CONTENTS |
1
2
3
4
5
6
7
8
9
10
5|Introduction
15|System Overview
37|Operation overview
45|Displaying and saving data
55|Ventilation modes
83|Ventilatory settings and functions
109|Alarm handling
123|Service & Settings
131|Technical data
159|Index
SERVO-airVentilator System v2.1, User's Manual
Infologic 1.39
3
| TABLE OF CONTENTS |
4
SERVO-airVentilator System v2.1, User's Manual
Infologic 1.39
1 Introduction Table of contents
| Introduction |
6|Device description1.1
8|Safety guidelines1.2
14|Version and configurations1.3
1 |
SERVO-airVentilator System v2.1, User's Manual
5
| Introduction |
| 1
1.1 Device description
1.1.1 Device components
The ventilator system consists of:
1. a user interface for setting ventilation
modes, displaying data and indicating
alarms
2. a patient unit for mixing gases and
controlling gas delivery
3. a patient circuit for delivering and
exchanging gases
1
1.1.2 Intended use
The SERVO-air ventilator system is:
• intended for respiratory support, monitoring
and treatment of pediatric and adult
patients
• to be used only by healthcare providers
• to be used only in professional healthcare
facilities and for transport within these
facilities
2
6
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SERVO-airVentilator System v2.1, User's Manual
| Introduction |
1 |
1.1.3 User's Manual
This manual summarizes the functions and
safety features of the ventilator system. It is
not all-inclusive and should not be seen as a
substitute for training.
1.1.4 Cleaning & Maintenance
Please refer to the SERVO-air Cleaning and
Maintenance User's Manual.
1.1.5 Servicing Guidelines
CAUTIONS:
• Regular service: The ventilator system
must be serviced at regular intervals by
Maquet authorized personnel who have
received specialized training.
• Complete service records: All service
performed on the ventilator system must
be recorded in a service log in
accordance with hospital procedures and
local and national regulations.
1.1.6 Disclaimers
Non-professional servicing:
Maquet has no responsibility for the safe
operation of the ventilator system if
installation, service or repairs are performed
by persons other than Maquet authorized
personnel.
• Service contract: It is strongly
recommended that all service on the
ventilator system should be performed
as part of a service contract with Maquet.
Note: If the ventilator system is to be a part
of another system it requires an evaluation
of the requirements of the IEC 60601-1
standard.
SERVO-airVentilator System v2.1, User's Manual
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| Introduction |
| 1
1.2 Safety guidelines
Follow these safety guidelines. Additional
warnings appear in context throughout this
document.
Information is highlighted with Warning,
Caution, Important or Note, where:
WARNING! Indicates critical information
about a potential serious outcome to the
patient or the user.
CAUTION: Indicates instructions that must
be followed in order to ensure the proper
operation of the equipment.
Important: Indicates information intended
as help to operate the equipment or its
connected devices easily and conveniently.
Note: Indicates information requiring special
attention.
1.2.1 General
WARNINGS!
• The ventilator system may be operated
only by authorized personnel who are
properly trained in its use. It must be
operated according to the instructions in
this User´s Manual.
• After unpacking, perform a routine
cleaning and a pre-use check.
• Always perform a pre-use check before
connecting the ventilator system to a
patient.
• Secure all tubing and cables to avoid the
risk of unwanted movement of the
equipment.
• If any of the following occurs, discontinue
use of the ventilator system and contact
a service technician:
- unfamiliar pop-up windows on the
screen
- unfamiliar sounds
- any unfamiliar or unexplained event
- alarms that cannot be resolved
• Make sure that a resuscitator is readily
available.
• The air inlet must not be occluded.
• Positive pressure ventilation can be
associated with the following adverse
events: barotrauma, hypoventilation,
hyperventilation or circulatory
impairment.
• Ventilation must be started manually
when a patient is connected to the
ventilator system.
• Keep the ventilator system upright during
use.
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SERVO-airVentilator System v2.1, User's Manual
| Introduction |
1 |
• Do not cover the ventilator system in any
way, since the functioning of the
equipment may be adversely affected.
• Do not modify or remove any original
parts.
• The ventilator system must not be used
during radiotherapy, since this may cause
system malfunction.
• The ventilator system must not be used
in a hyperbaric chamber.
• The ventilator system must be kept away
from magnetic resonance imaging (MRI)
equipment.
• The ventilator system must not be used
with helium or any gas mixture containing
helium.
• When the ventilator system is used with
MCare Remote Services, use only
network equipment that is safe and
complies with the relevant electrical and
EMC standards such as IEC 60950.
Note:The network cable is excluded
from this requirement.
• Only accessories, supplies, and auxiliary
equipment recommended by Maquet
should be used with the ventilator
system. Use of any other accessories,
spare parts or auxiliary equipment may
cause degraded system performance
and safety.
• Use only the Maquet approved active
humidifiers. Use of non-approved active
humidifiers may result in higher gas
temperatures and increase resistance in
filters.
• During humidification, carefully monitor
the airway pressure. Increased airway
pressure could result from a clogged
filter. Replace the filter if the expiratory
resistance increases or according to the
instructions for the filter, whichever
comes first.
• Service, repair and installation may only
be performed by Maquet authorized
personnel.
• The ambient sound needs to be taken
into consideration when setting the alarm
sound level.
• Always disconnect the patient from the
ventilator system when performing
operations that involve risk for the
patient, such as replacing the O2 cell,
dismantling etc.
CAUTIONS:
• Never leave the patient unattended when
connected to the ventilator system.
• Before use, make sure the system
version displayed under SYSTEM
STATUS/General corresponds to the
system version described in the User's
Manual.
• Maquet has no responsibility for the safe
operation of the ventilator system if the
requirements specified in Intended use
on page 6 are not followed.
• When lifting or moving the ventilator
system or parts of the system, follow
established ergonomic guidelines, ask
for assistance, and take appropriate
safety precautions. The weight is
specified on the ventilator system.
• The air inlet filter must be in place when
the system is running.
SERVO-airVentilator System v2.1, User's Manual
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| Introduction |
| 1
• The expiratory channel and expired gas
from the exhaust port may be
contaminated.
• If a scavenging system (i.e. gas
evacuation) is connected to the ventilator
system, it must conform to ISO
80601-2-13 guidelines for
subatmospheric pressure and induced
flow.
• During operation any water traps must
be checked regularly and if necessary
emptied.
• All technical documentation is available
for use by Maquet authorized personnel.
• When using the MCare Remote Services
function, instal the network cable so that
there is no risk of anyone tripping over
it.
• The ventilator system must not be used
with any anaesthetic agent.
Important:
• Portable and mobile radio frequency (RF)
communications equipment can affect
medical electrical equipment.
• The ventilator system must be installed
and put into service according to the
EMC declaration.
• Securely attach all cables, etc, to
minimize the risk of unintentional
disconnection.
• While the ventilator system is in use, the
wheels of the mobile cart must be locked
and the mobile cart must be in a
horizontal position.
• When the ventilator system is connected
to a patient:
- Do not lift or disconnect the expiratory
cassette.
- Continuously monitor the settings and
measurements displayed on the
screen.
• Always use a heat and moisture
exchanger (HME) or an active humidifier
to prevent dehydration of lung tissue.
• If a heated patient circuit is not used in
the system, a water trap must be used
on the expiratory tube to avoid
condensation in the system when an
active humidifier is used. During
operation the water traps must be
checked regularly and if necessary
emptied.
• Check that the cooling fan intakes are
not covered. Do not place the ventilator
system on soft surfaces.
• The air inlet filters must be checked
regularly and replaced if necessary.
• Use an inspiratory filter when ventilating
a highly infectious patient.
• All excess fluids must be disposed of
according to hospital routines.
• The emergency air intake must not be
blocked.
• Do not disconnect the expiratory
cassette while the ventilator system is in
operation; if necessary, disconnect the
cassette while in STANDBY.
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SERVO-airVentilator System v2.1, User's Manual
| Introduction |
1 |
Notes:
• Do not simultaneously touch the patient
and any accessible connector contacts.
• Do not solely rely on the use of an
external monitor to determine the status
of the patient and the ventilator system.
• Make sure that the ventilator system is
firmly mounted on the mobile cart.
• Make sure that cables and patient circuit
is not obstructed or squeezed due to
improper mounting.
• Extra care should be taken when
handling tubes, connectors and other
components of the patient circuit. The
use of a support arm to relieve the patient
from the weight of the tubing system is
recommended.
• Contact a Maquet representative
regarding decommissioning of the
equipment.
• Turn off the active humidifier during
nebulization.
• Expiratory filter connection is mandatory
during nebulization.
• A water trap is recommended if a single
heated patient circuit is used.
• Thermoshell, expiratory cassette must
be used when using heated expiratory
tubing or Expiratory heater Servo Duo
Guard.
1.2.2 Power supply
WARNINGS!
• The power cord must be connected only
to an AC mains power outlet with
protective earth to avoid the risk of
electric shock.
• The power supply cord must be plugged
directly into the mains power outlet
without the use of any multiple socket
outlets. If a multiple socket outlet is used
together with other products, total
leakage current might be exceeded in
the event of a fault in the protective earth.
CAUTIONS:
• Do NOT use antistatic or electrically
conductive tubing with this system.
• Avoid contact with external electrical
connector pins.
SERVO-airVentilator System v2.1, User's Manual
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| Introduction |
| 1
Important: In case of total loss of power
during ventilation, an alarm will sound for 2
minutes. When power is restored, the
ventilator system will start in the same state
and with the same settings as before the
power loss.
Note: When the system is connected to an
external power supply, all connected battery
modules are being recharged. This does
not affect ventilation.
Battery
WARNINGS!
• Do not use sharp tools when extracting
the batteries.
• To guarantee reliable battery backup,
make sure a battery is in place in slot 2
at all times during ventilation.
• Dispose of batteries according to local
regulations and not with ordinary waste.
CAUTION:
The battery modules must be charged
before first use.
Do not expose the batteries to water, fire
or excessive heat.
Do not crush, disassemble, puncture or
short circuit the connector terminals.
One battery can be added to an available
slot during operation.
Hold onto the battery strap when inserting
a battery in the ventilator system.
Important:
• If a battery status message is displayed
on the screen, always go to SYSTEM
STATUS/Batteries for detailed
information.
• Check battery in SYST EM
STATUS/Batteries window to ensure safe
battery operation. Always charge the
battery before use.
• Always replace batteries when the
ventilator system provides notification of
imminent expiration or of diminished
operating capacity.
• When not in use, the ventilator system
should always be connected to the mains
power to ensure fully charged batteries.
12
Refer to section Battery status on page 23.
SERVO-airVentilator System v2.1, User's Manual
| Introduction |
1 |
1.2.3 Fire hazard
WARNINGS!
• Keep all sources of ignition away from
the ventilator system and the oxygen
hoses.
• Do not use a ventilator system with worn
or frayed gas supply hoses or hoses that
have been contaminated by combustible
materials such as grease or oil.
• Oxygen-enriched gas is extremely
flammable: if a burning odor is detected,
disconnect the oxygen supply and mains
power and remove the batteries.
• Make sure that both the mains power
outlet and the power supply connector
are accessible.
1.2.4 Gases
1.2.5 Auxiliary equipment
CAUTION:
Measurements of numerical values that
have been processed by auxiliary
equipment:
• may be inaccurate if equipment not
authorized by Maquet is used
• should be disregarded if they conflict
with information on the ventilator screen
• must not be used as a substitute for
therapeutic or diagnostic decisions.
Accessories, supplies, and auxiliary equipment
used with the ventilator system must be
recommended by Maquet.
WARNING! The ventilator system must not
be used with helium or any gas mixture
containing helium.
Refer to section Ventilator system on page 134.
SERVO-airVentilator System v2.1, User's Manual
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| Introduction |
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1.3 Version and configurations
This manual applies to version 2.1 of the SERVO-air ventilator system.
1.3.1 Configurations
The ventilator system can be used in both invasive and non invasive ventilation.
The configurations includes adult and pediatric.
Refer to section System on page 132.
1.3.2 Available modes and functions
Patient categoryModes/Functions
SIMV
• (PC) + PS
• (PRVC) + PS
• (VC) + PS
X
O
X
AdultPediatric
XXPC
OOPRVC
XXVC
OOBi-Vent/APRV
XXPS/CPAP
OOVS
OOAutomode
X
O
X
OONIV PC
OONIV PS
XXNebulizer
OOAlarm output connection
14
O = option— = not applicableX = standard
SERVO-airVentilator System v2.1, User's Manual
2 System Overview Table of contents
| System Overview |
16|Ventilator2.1
18|Patient unit2.2
22|Batteries2.3
24|Patient circuit2.4
29|User interface2.5
36|Transport2.6
2 |
SERVO-airVentilator System v2.1, User's Manual
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2.1 Ventilator
The ventilator consists of a user interface and
a patient unit.
Air is supplied from ambient air by an internal
turbine and O2 may be supplied by a medical
pipeline system or by gas cylinder.
2.1.1 Mounting on mobile cart
• Lock the wheels.
• Release the locking clamp on the mobile
cart.
• Stand directly in front of the mobile cart
when mounting the ventilator system.
• Tilt the ventilator system to fit the two front
clamps in position on the mobile cart.
• Press down the rear end of the ventilator to
fit the rear clamp in position.
• Lock the ventilator system to the mobile
cart with the locking clamp.
• Ensure that the patient unit is firmly fixed
to the mobile cart via the clamps and
locking clamp.
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2 |
2
3
1
1. Patient unit
2. User interface
3. Expiratory inlet
4. Inspiratory outlet
5. Emergency air intake
6. Air inlet
7. Battery compartment
8. Patient circuit
9. AC mains power
10. O2 supply
11. Wheel lock
11
4
6
5
7
8
9
10
Note: Lock the wheels whenever the
ventilator system is standing still.
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2.2 Patient unit
1
2
3
4
5
6 8 9 10
7
14
13
12
11
15
16
18
17
20
21
19
1. On/Off switch
The switch must be pulled downwards
before it can be switched.
2. Expiratory outlet
3. Power indicators
4. RS-232 connectors
5. Equipotentiality terminal.
6. AC mains power source connector with
fuse
7. Alarm output connection
8. External +12V DC inlet
9. Fuse for external DC power
10. Ethernet connection
18
11. Battery compartments
12. USB ports
13. Gas inlet for O
14. Gas inlet for air including air inlet filter
15. Inspiratory outlet
16. Emergency air intake
17. Nebulizer connector
18. Expiratory inlet
19. Cooling fan with filter (on both sides)
20. Expiratory cassette
21. Expiratory inlet with moisture trap
2
SERVO-airVentilator System v2.1, User's Manual
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2 |
Important: No other external devices than
a USB memory stick may be connected to
the USB ports. Only one memory stick can
be used at the same time.
2.2.1 Symbols on patient unit
DescriptionSymbol
CE label—indicates compliance with
the requirements of the Medical
Device Directive 93/42/EEC
CSA label—Indicates compliance
with Canadian and US standards
UDI Label - Unique Device
Identification. Refer to section UDI
label on page 156.
Rx
ONLY
In USA, Federal law restricts this
device to sale by or on the order of
a physician.
Type B—indicates classification
according to IEC 60601-1
Type BF applied part — indicates
classification according to IEC
60601-1
Potential equalization terminal
Note: The potential equalization
terminal is designed for the
connection of a potential equalization
conductor according to DIN 42 801
and IEC 60601-1. The function of the
potential equalization terminal is to
equalize potentials between the
ventilator system and other medical
devices that can be touched
simultaneously. The potential
equalization terminal must not be
used for a protective earth
connection.
SERVO-airVentilator System v2.1, User's Manual
-
+
12V
-
+
Nebulizer connector
RS-232/Serial port - connector for
data communication
Ingress protection, IP21
Fuse (specification)
External 12V DC input
Battery
Expiratory gas flow from the patient
Inpiratory gas flow to patient
19
| System Overview |
| 2
DescriptionSymbol
Mains power On/Off
Mains connected, batteries charging
Gas exhaust port—exhaust gas flow
from ventilator system
Network connection
USB connection
Alarm output connection
Special waste
Note: This product contains
electronic and electrical components.
Discard disposable, replaced and
left-over parts in accordance with
appropriate industrial and
environmental standards.
Caution
Consult instructions for use
DescriptionSymbol
MR Unsafe - keep away from
magnetic resonance imaging (MRI)
equipment.
20
Consult accompanying
documentation
Locked
Unlocked
Serial number
Order number
Weight of patient unit with user
interface and ventilator including its
safe working load.
Use of ON/OFF switch
The switch must be pulled
downwards before it can be
switched.
Manufacturer
The symbol is accompanied by
manufacturer address and
manufacturing date.
SERVO-airVentilator System v2.1, User's Manual
2.2.2 Gas flow through the patient unit
| System Overview |
2 |
8
6
7
9
11
10
1. Air inlet with air inlet filter.
2. Turbine module for ambient air.
3. The check valve prevents the gas to flow
backwards.
4. Gas inlet for O2.
5. The gas module for O2 regulates the O
gas flow.
6. The flow meter measures the gas flow.
7. The pressure of the gas delivered to the
patient is measured by the inspiratory
pressure transducer. The transducer is
protected by a bacterial filter.
2
5
3 1
2
4
12 13
14
10. The expiratory inlet in the expiratory
cassette contains a moisture trap.
11. The ultrasonic transducers in the
expiratory cassette measure the outgoing
gas flow.
12. The expiratory pressure transducer in the
expiratory cassette measures the pressure
in the patient circuit. The transducer is
protected by a bacterial filter.
13. The expiratory valve in the expiratory
cassette regulates the pressure in the
patient circuit.
14. Exhaust port.
8. The O2 cell measures the oxygen
concentration. The O2 cell is protected by
a bacterial/viral filter.
9. The inspiratory channel delivers gas to the
patient circuit inspiratory tubing and
contains a safety valve.
SERVO-airVentilator System v2.1, User's Manual
Note: The expiratory cassette can be
exchanged between different ventilator
systems. Always perform a pre-use check
after exchanging an expiratory cassette.
21
| System Overview |
| 2
2.3 Batteries
2.3.1 Charging battery modules
Important: The battery modules are
delivered in shipping-mode and must be
charged before use.
To charge the battery modules, insert the
battery modules in the ventilator system. The
ventilator must be connected to mains. The
battery modules are charged automatically.
The batteries can also be charged with the
External battery charger, SERVO-air.
2.3.2 Handling battery modules
The battery compartment is divided into two
slots, 1 and 2.
The ventilator system uses the battery in slot
1 first. Make sure that the battery in slot 2 is
in place as a backup at all times during
ventilation.
Refer to section Battery on page 12.
• Remove the battery from the ventilator
system.
To insert a battery module:
• Hold onto the battery strap when inserting
a battery in the ventilator system.
When inserting a battery module in slot 1,
check that the battery strap for the battery
in slot 2 is not folded into the battery
compartment.
• Ensure that the battery is fully inserted so
that the release button returns to a
completely closed position.
1
2
1
2
The battery module in slot 1 may be
exchanged during ventilation.
To remove a battery module:
• Press the release button to the left and pull
the battery strap.
22
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2 |
2.3.3 Battery status
Important:
• If Replace battery is displayed, the
battery is unreliable, regardless of the
operating time displayed under Batteries.
In this situation, replace the battery even
when the STATUS window indicates that
significant operating time remains.
• At least one battery module must always
be installed.
Detailed information about batteries is
accessed via SYSTEM STATUS/Batteries.
There is also an indication in the status bar
showing the power supply currently being
used by the ventilator system.
If the ventilator system is running on battery
power, the active battery in the battery symbol
turns yellow and the mains power symbol
disappears. The estimated remaining battery
time in minutes is always displayed, regardless
of the power supply in use.
The following information is displayed under
Batteries in SYSTEM STATUS for each
connected battery module:
• BATTERY CAPACITY – usable backup time
in minutes
An estimated backup time is shown in
Standby. This estimate may differ from the
actual usable backup time during running.
Usable backup time depends on set mode
and selected ventilation settings.
Note: The presented usable backup time
is the sum of the estimated operation
time displayed for each battery module
minus 20 minutes.
• Slot number
• Serial number
• Remaining operation time in minutes for
each battery
• Notification – may be displayed close to the
remaining operation time in minutes.
• Remaining battery life
The battery symbol also functions as a
shortcut to the window otherwise accessed
via SYSTEM STATUS/Batteries.
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2.4 Patient circuit
Notes:
• Turn off the active humidifier during
nebulization.
• Expiratory filter connection is mandatory
during nebulization.
• A water trap is recommended if a single
heated patient circuit is used.
• Thermoshell, expiratory cassette must
be used when using heated expiratory
tubing or Expiratory heater Servo Duo
Guard.
• To ensure that the inspiratory gas
temperature is below 43°C the patient
circuit inspiratory tube must be at least
1.2 m to let the gas cool down.
Refer to System Flow Chart, SERVO-air for
information regarding patient circuit
configurations to be used with the ventilator
system.
24
SERVO-airVentilator System v2.1, User's Manual
15 - 22 mm Ø patient circuit, reusable
5
2
4
2
3
| System Overview |
2 |
1
4
1. Inspiratory patient tube
2. Y piece
3. Heat and moisture exchanger (HME)
4. Angled adapter for endotracheal tube
7
6
5. Aerogen Pro
6. Expiratory patient tube
7. Expiratory filter
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| System Overview |
| 2
22 mm Ø patient circuit, dual heat disposable
8
6
7
5
6
7
1. Inspiratory patient tube
2. Water autofill
3. Humidification chamber
4. Active humidifier
5. Cuff with temperature port
6. Y piece
2
1
1
3
4
9
10
12
11
7. Angled adapter for endotracheal tube
8. Aerogen Solo
9. Expiratory patient tube
10. Expiratory filter
11. Expiratory heater Servo Duo Guard
12. Thermoshell, expiratory cassette
26
SERVO-airVentilator System v2.1, User's Manual
10 mm Ø patient circuit, single heat reusable
| System Overview |
2 |
9
6
8
5
6
7
1. Inspiratory patient tube
2. Water autofill
3. Humidification chamber
4. Active humidifier
5. Cuff with temperature port
6. Y piece
10
11
2
1
1
3
4
10
7. Angled adapter for endotracheal tube
8. Pressure line connection port
9. Aerogen Pro
10. Expiratory patient tube
11. Water trap
12. Expiratory filter
12
SERVO-airVentilator System v2.1, User's Manual
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| System Overview |
| 2
10 mm Ø patient circuit, dual heat disposable
11
5
10
9
6
7
8
1. Inspiratory patient tube
2. Water autofill
3. Humidification chamber
4. Active humidifier
5. Cuff with temperature port
6. Extension tube for incubator use
7. Angled Y piece
8. Pressure line connection port
2
1
1
3
4
5
13
15
12
9. Angled adapter for endotracheal tube
10. Y piece
11. Aerogen Solo
12. Expiratory patient tube
13. Expiratory filter
14. Expiratory heater Servo Duo Guard
15. Thermoshell, expiratory cassette
14
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SERVO-airVentilator System v2.1, User's Manual
2.5 User interface
1
2.5.1 User interface adjustment
2
2. Loudspeaker1. Alarm indicator
2.5.2 Interactive areas
| System Overview |
2 |
The user interface can be adjusted into
different positions.
1
2
3
4
5
The user interface is completely touch based
and is divided into the following areas:
1. Status bar
2. Quick menu/extended menu
3. Display area
4. Direct access bar/media bar
5. Numerical values
SERVO-airVentilator System v2.1, User's Manual
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| System Overview |
| 2
Important:
• Do not use sharp tools on the screen.
• Fluid on the screen can disturb touch
functionality.
2.5.3 Navigating
To navigate the user interface, adjust settings
and get support:
• Tap (the touchpad changes color when the
navigating is registered).
• Tap and hold
• Scroll vertically or horizontally
• Drag and drop
2.5.4 User support
The user is supported by the following:
• Alarm management
• Safety scales
• Dynamic images
• Information texts
• Pre-use check instructions
• Shortcuts
• Prompts
Note:
The following colors are used for settings:
• Red — not recommended
• Yellow — use with caution
• Green — normal
Alarm management
1
2
30
3
4
1. Alarm list
2. Number of active alarms
3. Alarm management checklist
4. Alarm history
Refer to chapter Alarm handling on page 109.
SERVO-airVentilator System v2.1, User's Manual
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