Oxylog Ve300
Oxylog Ve300
Oxylog Ve300
Oxylog VE300
Contents
3 Overview ................................................................................................... 17
3.1 Main device..................................................................................... 17
3.2 Main device with carrying system ................................................... 20
3.3 Breathing circuits ............................................................................ 21
3.4 Range of functions.......................................................................... 23
3.5 Abbreviations .................................................................................. 24
3.6 Symbols .......................................................................................... 25
7 Operation .................................................................................................. 55
7.1 Switching on the device .................................................................. 55
7.2 Preparing the ventilation mode ....................................................... 55
7.3 Selecting the ventilation mode........................................................ 56
7.4 Changing the ventilation mode ....................................................... 63
7.5 Non-invasive ventilation (NIV) ........................................................ 64
7.6 O2/air mix........................................................................................ 66
7.7 Switching to standby mode and turning off the device ................... 67
8 Alarms....................................................................................................... 69
8.1 Safety information........................................................................... 69
8.2 Alarm priorities................................................................................ 69
8.3 Alarm indication .............................................................................. 70
8.4 Setting alarm limits ......................................................................... 71
9 Configuration ........................................................................................... 74
9.1 Setting configuration parameters.................................................... 74
9.2 Adjusting the screen brightness...................................................... 75
9.3 Setting the breathing circuit ............................................................ 75
9.4 Setting the HME correction............................................................. 75
9.5 Setting the ventilation mode for the ventilation category "Ventilation
(volume)" 75
9.6 Setting the CO2 cuvette type (option) ............................................. 76
9.7 Using the Bluetooth function (option).............................................. 76
9.8 Activating the screenshot function (option)..................................... 77
9.9 Advanced system setup.................................................................. 78
11 Troubleshooting....................................................................................... 88
11.1 Alarm – Cause – Remedy............................................................... 88
11.2 Messages in the alarm message field ............................................ 88
11.3 Messages in the notification field.................................................... 96
11.4 Error messages during the system test .......................................... 97
12 Reprocessing ........................................................................................... 98
12.1 Disassembly ................................................................................... 98
12.2 Information on reprocessing ........................................................... 101
12.3 Safety information........................................................................... 101
12.4 Classification for reprocessing........................................................ 101
12.5 Recommendations for reprocessing ............................................... 102
12.6 Reprocessing the non-critical components..................................... 104
12.7 Reprocessing list ............................................................................ 104
12.8 Assembly ........................................................................................ 105
Index.......................................................................................................... 130
1.3 Illustrations
Depending on the configuration, the products and screen content shown in this
document may differ from the actual on-site products.
1.4 Trademarks
Trademarks owned by Dräger
The trademarks are registered in the following countries:
Trademark Country
Oxylog® Germany, EU, USA, Australia
DrägerService® Germany, USA
MEDIBUS.X® EU, USA
ClassicStar® EU, USA
NovaStar® EU, USA
Trademark
Trademark
BIPAP1)
1) Licensed trademark
2 Safety-related information
2.1 Intended use
Oxylog VE300 is a time-cycled, volume-controlled and pressure-controlled
emergency and transport ventilator for patients requiring mandatory or assisted
ventilation with a tidal volume from 100 mL upward.
2.2 Indications
For patients with a tidal volume of 100 mL upward.
2.3 Contraindications
Patients with a tidal volume of 100 mL or less.
WARNING
Risk of patient injury
The device is not intended for long-term use.
► Do not use the device as an intensive care ventilator.
WARNING
Risk of patient injury and device malfunction
Do not use the device in hyperbaric chambers.
► This may result in danger to the patient and malfunctioning of the device.
WARNING
Risk of patient injury and device malfunction
Do not use the device in conjunction with magnetic resonance imaging (MRI).
► This may result in danger to the patient and malfunctioning of the device.
WARNING
Risk of explosion and fire
The device is not approved for use in areas where oxygen concentrations greater
than 25 Vol% and combustible or explosive gas mixtures are likely to occur.
► This may result in risk of explosion and fire.
2.6.2.1 Users
Task Requirement
Use of the product in accordance with Specialist medical knowledge in respira-
the intended use tory care and the use of the medical
device
Task Requirement
Reprocessing Specialist knowledge in the reprocess-
ing of medical devices
Task Requirement
Installation Specialist knowledge in electrical engi-
Basic service work (inspection, mainte- neering and mechanics
nance according to the "Service" chap- Experience in the servicing of medical
ter) devices
Task Requirement
Installation Specialist knowledge in electrical engi-
Basic and complex service work neering and mechanics
(inspection, maintenance, repair) Experience in the servicing of medical
devices
Experience in complex service work on
this product
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with different underlying diseases
2.8.7 Alarms
Failure to notice alarm signals may put the patient at risk.
► Before operation, check that the visual and acoustic alarm signals are working
correctly. To do so, generate any alarm, e.g. O2 supply pressure low.
► Set the alarm volume so that alarm signals can be heard.
► The user must stay within hearing range of the acoustic alarm signal.
► Pay additional attention in environments where the surrounding noise interferes
with hearing the maximum alarm volume of the device (e.g., in a helicopter).
► Make sure that the alarm system has not been rendered useless by setting the
alarm limits to extreme values.
► Check the display regularly for optical alarm signals when the acoustic alarm
signals are silenced.
2.8.8 Accessories
The use of incompatible accessories may adversely affect the functional integrity of
the product. Personal injury and property damage may result.
► Use only compatible accessories. The accessories that are compatible with this
product are listed in the list of accessories supplied with the product.
► Do not use any antistatic or electrically conductive breathing circuits.
2.8.10 Service
If service is not performed regularly, malfunctions may occur, which can result in
personal injury and property damage.
► Perform service work as described in "Service".
Electromagnetic interferences
Wireless communication devices (e.g., cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic
radiation. When such devices are operated too close to this device or its cables, the
functional integrity of this device may be compromised by electromagnetic
interferences. As a result, the patient could be put at risk.
► Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless
communication devices, to ensure that the essential performance characteristics
of this device are fulfilled.
► Maintain an adequate distance between this device and other medical electrical
equipment.
Risk of infection
The device must be reprocessed, otherwise there is an increased risk of infection
and the function of the device may be impaired.
► Observe the hygiene regulations at the operating location (e.g., hospital or
ambulance station), including the reprocessing intervals and reprocessing
procedures.
► Have reprocessing personnel perform reprocessing with validated procedures.
► Reprocess reusable products before their first use and after each use.
► Follow the manufacturer's instructions in respect of cleaning agents and
disinfectants.
► Reprocess the product before performing service activities or returning it for
repair. For further information, see the following chapter:
"Reprocessing", page 98.
Service
This product must be maintained at regular intervals and in the appropriate manner.
Failure to perform service activities correctly may result in personal injury and
property damage.
► Perform service activities. For further information, see the following chapter:
"Service", page 106.
► Service must be performed by those target groups that are assigned to the
particular measure.
► Only carry out service activities when there is no patient connected to the
device.
Device malfunction
If a malfunction is detected in the ventilator, and its life-preserving function can no
longer be ensured (e.g., in the event of a power failure or an interruption of the gas
supply), ventilation with an independent ventilation device (breathing bag) must be
started immediately.
► Keep a manual resuscitator at the ready.
► Ventilate with PEEP and/or increased inspiratory O2 concentration if necessary.
3 Overview
3.1 Main device
Upper side
28169
A B C D
E
F
K J I H G
Rear
28170
A
Front
28171
A B C D E
CAUTION
Ventilator malfunction
Do not block the emergency air inlet.
► A blocked emergency air inlet may result in ventilator malfunction.
Devices with the Plus option are indicated by labels on the sides of the device.
33377
A B C D E A
Bottom view
33374
A B C B A
30060
C
D
E
A
No. Designation
A Elbow
B Pressure sensor
C Breathing valve
D Breathing hose
E Pressure measuring line
33256
B C
A D E
No. Designation
A Red protection cap
B Elbow
C Breathing valve
D Breathing hose
E Device-side connectors
28172
C
D
E
A
No. Designation
A Elbow
B Flow sensor
C Breathing valve
D Breathing hose
E Flow and pressure measuring lines
33257
F
D
A B C E
G
No. Designation
A Red protection cap
B Elbow
C Flow sensor
D Breathing valve
E Breathing hose
F Flow and pressure measuring lines
G Device-side connectors
In these instructions for use the unit of measurement for airway pressure is
expressed in [mbar].
3.5 Abbreviations
Abbreviation Explanation
BF Body floating
BTPS Body Temperature and Pressure, Saturated
Corresponds to conditions of patient's lungs: 37 °C (98.6 °F),
ambient pressure, 100 % relative humidity
cmH2O Centimeters of water
CO2 Carbon dioxide
CPR Cardiopulmonary resuscitation
dB(A) Sound pressure level, A-weighted
∆Psupp Pressure support above PEEP
EMC Electromagnetic compatibility
ESD Electrostatic Discharge, electrostatic discharge
etCO2 End-tidal CO2 concentration
HME Heat and moisture exchanger
hPa Hectopascal
I:E Ratio of inspiratory time to expiratory time
IPX4 Degree of protection against ingressing liquids, level 4
kPa Kilopascal
L/min Liter per minute
LED Light-emitting diode
mbar Millibar
MEDIBUS.X Communication protocol for medical devices with uniform data
definition for all devices
min Minute
mmHg Millimeter of mercury
MRI Magnetic resonance imaging
MVe Expiratory minute volume
MVi Inspiratory minute volume
NIV Non-invasive ventilation (mask ventilation)
O2 Oxygen
Paw Airway pressure
PC-BIPAP Pressure-controlled - spontaneous breathing with continuous
positive airway pressure with 2 different pressure levels
PEEP Positive end-expiratory pressure
PGM Patient gas measurement
Pinsp Inspiratory pressure
PIP Peak inspiratory pressure
Pmax Pressure limitation
PS Pressure support
Abbreviation Explanation
QR code Quick Response Code
RR Respiratory rate
SPN-CPAP Spontaneous continuous positive airway pressure
Ti Inspiratory time
UMDNS Universal Medical Device Nomenclature System, nomenclature
for medical devices
USB Universal Serial Bus, computer interface
VC-AC Volume-controlled - assisted-controlled ventilation
VC-CMV Volume-controlled - controlled mandatory ventilation
VC-SIMV Volume-controlled - synchronized intermittent mandatory venti-
lation
VDC Volt direct current
Vol.% Percentage gas ratio, related to total volume
VT Tidal volume
VTe Expiratory tidal volume
VTi Inspiratory tidal volume
3.6 Symbols
Symbol Explanation
Manufacturer
DC voltage
Mains power
Symbol Explanation
DC input
Battery compartment
Start/standby key
Serial number
Revision index
Nominal weight
Maximum weight
Symbol Explanation
NON
STERILE Non-sterile
Storage temperature
Radio transmitter
Relative humidity
Atmospheric pressure
Do not reuse
Quantity
Use by
Screenshot
Bluetooth
USB port
4 Operating concept
4.1 Control elements
28174
A
D C B
No. Designation
A Rotary knob for making selections, changing and confirming settings
B Start dialog key to return from any dialog to the start dialog
C Key to rotate the screen orientation by 180°
D Key to silence acoustic alarm signals for 2 minutes
28206
A B C D E F
No. Designation
A Patient category
B Ventilation category (CPR, Ventilation (volume), Ventilation (pressure),
CPAP) and ventilation mode (VC-CMV, VC-AC, VC-SIMV, PC-BIPAP,
SPN-CPAP)
C Display of power supply and remaining duration of battery operation
D Oxygen mode (100 % O2, O2/air mix)
E Display of current gas consumption
F Button to switch or exit the dialog
G Dialog (available: start dialog, configuration dialog, ventilation dialog,
service dialog)
28210
A
B C
No. Designation
A Text Standby and date of last system test or alarm message
B Step 1: Select the patient category (buttons Adult, Child)
C Step 2: Select the ventilation category (buttons CPR, Ventilation
(volume), Ventilation (pressure), CPAP)
D Step 3: Start ventilation (button Start ventilation)
If the device is in standby mode (e.g., immediately after startup), the date and
result of the last system test are displayed in the standby mode area.
Ventilation dialog
28209
A F
B
F
D C
E
No. Designation
A Display of pressure bar for Paw in mbar or waveforms for Paw, Flow, CO2
(option)
B Display of measured values for the parameters PIP, RR, MVe (option),
VTe (option), and etCO2 (option)
C Button Alarm settings (For further information, see the following chapter:
"Setting alarm limits", page 71)
D Button More settings
E Therapy controls for frequently used parameters (depending on the venti-
lation setting, e.g., VT and RR or PEEP and Pmax). The black triangle
indicates the preset parameter value.
F Toggle symbol. By tapping in a parameter field with this symbol it is possi-
ble to change between the possible parameters.
The device determines MVe and VTe values under BTPS conditions.
If the values for MVe and VTe cannot be determined due to malfunctions, the
inspiratory values MVi and VTi are displayed.
WARNING
Risk of patient injury
If the pressure reducer on the oxygen cylinder protrudes beyond the protection bar,
it may be damaged or knocked off.
► Place the oxygen cylinder in the carrying system so that the pressure reducer
does not protrude beyond the protection bar.
► The oxygen compressed gas hose must not protrude beyond the protection bar,
otherwise it may catch on objects.
WARNING
Risk of patient injury
If the quick-coupling port of the Alduk IV pressure reducer is used, the connection
will protrude beyond the standard protection bar.
► Always use the wide protection bar when using the quick-coupling port of the
Alduk IV pressure reducer.
Assembly
1. Connect a pressure reducer to the oxygen cylinder or use an oxygen cylinder
with a built-in pressure reducer.
2. Open the device closure and open the device.
3. Place the cylinder in the well of the base plate and position the oxygen cylinder
so that the pressure reducer is on the side of the bar and the cylinder body is
resting on all 4 rubber feet.
33375
A
A
4. Adjust the hinge and closure length once to the diameter of the oxygen cylinder:
Remove the upper screw of the hinge with a hexagon key, remove the protective
plate and loosen the 2 screws beneath the plate.
Set the catch (A) so that the ventilator is resting horizontally on the cylinder, and
then re-tighten the screws. Refit the protective plate.
Loosen the 2 screws of the closure, set the closure to the same scale value as
the hinge, and then re-tighten the screws. Make sure that the closures do not
wiggle easily when closed and adjust the catch to a lower position if necessary.
WARNING
Risk of patient injury
A covering on the oxygen cylinder (e.g., a net) prevents sufficient fixation of the
oxygen cylinder in the ventilator.
► Make sure that the oxygen cylinder is mounted in the ventilator with no
covering over it.
5. Connect the oxygen compressed gas hose to the pressure reducer and the
ventilator.
6. Rotate the cylinder so that the pressure reducer and the hose to not protrude
beyond the bar.
7. Attach and fasten both closures until they engage audibly.
WARNING
Risk of patient injury
If the oxygen cylinder is not properly mounted, it may slip out of the carrying
system.
► Make sure that the oxygen cylinder is mounted securely in the carrying
system.
WARNING
Risk of patient injury and damage to the device
After the device falls with the carrying system, the closures, hinges and bar may no
longer be in proper functioning order to safely hold the oxygen cylinder.
► Check the closures, hinges, and protection bar to ensure functional integrity and
replace them if necessary.
NOTICE
► To activate: Fully charge the battery before commissioning.
CAUTION
Risk of patient injury
If the battery is replaced with the device switched on and no external power supply
connected, the device will interrupt ventilation of the patient.
► If a charged battery is inserted within 30 seconds, ventilation is automatically
resumed with the last values and alarm settings.
► After 30 seconds the device starts with the last set values or it needs to be re-
started. All ventilation settings and alarm settings are set to the presettings.
CAUTION
Risk of patient injury
If the external power supply fails and no charged battery is installed, ventilation of
the patient will be interrupted.
► Always insert a charged battery.
WARNING
Risk of patient injury and damage to the device
When using the DC/DC converter in damp or wet environments, there is a risk of
electric shock and damage to the device.
► The DC/DC converter must be used in dry locations only.
The DC/DC converter must be used to connect the device to on-board power
supply, such as in ambulances.
It can be used with the following voltages:
– 12 VDC
– 24 VDC
– 28 VDC
The device cannot use the input voltage outside the range. The on-board power
supply must be protected by a suitable 10 to 16 A DC fuse.
Mount the DC/DC converter on a flat wall and make sure that the wall is solid
enough to support the bracket. Use all 4 mounting holes (screw size M4).
1. Plug the large connector of the DC/DC converter into the on-board power
supply.
2. Plug the small connector into the device's DC socket.
3. Check if the device is connected correctly to the external power source.
– The LED next to the battery status indicator lights up green when the battery
is charged.
– The LED next to the battery status indicator flashes green when the battery is
charging.
– The LED next to the battery status indicator lights up yellow if the battery is
faulty, or no battery is inserted.
WARNING
Risk of patient injury and damage to the device
When using the power supply unit outdoors, there is a risk of electric shock and
damage to the device.
► Do not use the power supply unit outdoors.
► Do not touch the power supply unit and the patient at the same time.
WARNING
Risk of ventilator malfunction
Components installed in the gas supply line may cause device malfunctions.
► Do not install dosage valves or flowmeters in the device's gas supply line.
► To avoid insufficient oxygen supply during use, always check the oxygen
cylinder pressure before use.
30239
D
C
B
O2 A
30242
B
1. Connect the oxygen compressed gas hose (A) to the standard port (B) or to the
additional quick-coupling port of the device.
2. Connect the gas probe (C) to the oxygen terminal unit until it locks in place and
the oxygen supply is assured.
For information on the correct assembly of the main device with carrying system,
see page 33.
WARNING
Risk of ventilator malfunction
Components installed in the gas supply line might cause malfunctions.
► Do not install dosage valves or flowmeters in the device's gas supply line.
► To avoid insufficient oxygen supply during use, always check the cylinder's
oxygen pressure before use.
30244
A
B
C
30248
B
1. Make sure that the patient is receiving oxygen from the built-in oxygen cylinder.
2. Connect the gas probe of the oxygen compressed gas hose (A) to the oxygen
terminal unit.
3. Connect the oxygen compressed gas hose to the device's quick-coupling port
(B) until it locks in place and the oxygen supply is assured.
4. Slowly close the valve of the built-in oxygen cylinder.
Sterilize or disinfect all reusable parts before every use. For further information,
see the following chapter: "Reprocessing", page 98.
CAUTION
Risk of patient injury
A bent or twisted breathing hose may put the patient at risk.
► Make sure that the breathing hoses are not bent or twisted.
CAUTION
Risk of patient injury
A breathing hose that does not correspond to the device settings may put the
patient at risk.
► When connecting a breathing hose, make sure that the hose settings in the
configuration dialog correspond to the connected hose. For further information,
see the following chapter: "Setting the breathing circuit", page 75.
30064
A
WARNING
Risk of CO2 rebreathing
An incorrectly assembled or malfunctioning breathing valve may put the patient at
risk.
► Do not remove, damage, or bend the rubber disk (A) in the housing.
30252
A
1. Place the diaphragm (B) in the breathing valve housing (C). Make sure that it is
fitted correctly.
2. Mount the cover (A) and turn it about 60° clockwise until it engages.
3. Push the pressure sensor (D) onto the breathing valve (C). To do so, align the
pressure sensor (D) on the breathing valve using the grooves in the pressure
sensor.
4. Push the elbow onto the pressure sensor (D).
30253
A
30064
A
WARNING
Risk of CO2 rebreathing
An incorrectly assembled or malfunctioning breathing valve may put the patient at
risk.
► Do not remove, damage, or bend the rubber disk (A) in the housing.
30065
A
1. Place the diaphragm (B) in the breathing valve housing (C). Make sure that it is
fitted correctly.
2. Mount the cover (A) and turn it about 60° clockwise until it engages.
3. Push the flow sensor (D) onto the breathing valve (C). To do so, align the flow
sensor (D) on the breathing valve (C) using the grooves in the flow sensor.
4. Push the elbow (E) onto the flow sensor (D).
30066
A
B
B
WARNING
Risk of patient injury
Soiling of the disposable breathing circuit may put the patient at risk.
► Open the packaging of disposable breathing circuits only immediately before
use.
WARNING
Risk of patient injury
Soiling of the disposable breathing circuit may put the patient at risk.
► Open the packaging of disposable breathing circuits only immediately before
use.
1. Connect the flow measuring lines to the device. Correct alignment is indicated
by a groove on the connector, which must point away from the breathing hose. If
it is incorrectly seated, incorrect values will be displayed.
2. Connect the breathing hose to the device's gas outlet.
WARNING
Risk of CO2 rebreathing
Bacteria filters, HMEs, catheter mounts, and masks increase the resistance and
dead space of the breathing circuit.
► Note the manufacturer’s directions.
When using an HME, the measured flow may deviate from the actual expiratory
flow, because temperature and humidity of the breathing gas are reduced.
The flow and volume measurements can be adjusted for use with an HME. For
further information, see the following chapter: "Setting the HME
correction", page 75.
Connect the bacteria filter or HME to the elbow as follows:
30187
A
B
● Connect the bacteria filter, HME or catheter mount (A) to the patient port on the
breathing circuit (B).
30189
B
A C D
1. Disconnect the elbow (A) from the flow sensor or pressure sensor.
2. Connect the CO2 cuvette (C) to the flow sensor or pressure sensor so that the
windows point to the side.
3. Attach the elbow (A) to the CO2 cuvette (C).
4. Push the CO2 sensor (B) onto the CO2 cuvette (C), with the cable toward the
device.
5. Connect the CO2 sensor (B) to the port on the device.
6. Insert the CO2 sensor cable in the cable clips on the breathing hose.
Alternatively, connect the CO2 cuvette directly to the patient port of the elbow,
without disconnecting the elbow from the flow sensor.
After connecting the CO2 sensor (mainstream measurement, PGM algorithm,
atmospheric pressure compensation) or after a power supply failure, the sensor
must warm up for approx. 3 minutes before it is ready for operation. Pay attention to
the following during the warm-up phase and at temperatures below 10 °C (50 °F):
– The etCO2 and CO2 values may have a reduced accuracy.
The CO2 sensor cable may be extended with a maximum of one extension cable.
For further information, see the following chapter: "List of accessories", page 125.
WARNING
Risk of patient injury and damage to the device
The device might come loose and drop when being transported with the rail holder.
► Observe wall clearance requirements.
► Secure or protect the device by additional means when transporting it.
34113
ืPP !PP
6 Getting started
6.1 Charging the battery
The battery temperature must be between 0 and 45 °C (32 °F and 113 °F) when
charging the battery.
WARNING
Risk of patient injury
The battery is not charged outside the specified temperature range.
► Observe the permitted temperature when charging the battery. For further
information, see the following chapter: "Operating data", page 118.
28174
A
The LED next to the battery symbol (A) lights up when an external power source is
connected.
A two-colored indicator (A) lights up to show the current state of battery charge:
– Flashing green: The battery is charging.
– Lit green: The battery is fully-charged.
– Yellow: A battery is not inserted or cannot be charged.
The LED beside the battery symbol remains unlit while the ventilator is being
operated by the battery.
An external battery charger connected to the mains power supply can be used to
charge an extra battery. For further information, see the following chapter: "List of
accessories", page 125.
When the device is switched on, the remaining battery charge is displayed in the
header bar below the oxygen mode as a symbol, in increments of 25 percent. In
addition, the remaining duration of operation (H:MM) is displayed (A). The numeric
display appears after a short delay on startup.
– The accuracy of the indicated battery charge may vary depending on the age
and condition of the battery.
– When other messages need to be displayed in the notification field, the indicated
battery charge will not be visible.
– Additional alarms draw attention to the remaining duration of operation of the
battery.
WARNING
Risk of patient injury
If the oxygen supply is insufficient during operation, the patient may be put at risk.
► Before starting operation, check the cylinder pressure on the pressure gauge of
the pressure reducer so as to rule out the possibility of insufficient oxygen supply
during operation.
► Always have a full replacement oxygen cylinder ready.
The displayed value may be smaller than the expected minute volume, as it is
not subject to the BTPS correction.
29375
A
The system test can be canceled at any time by touching the X button in the
top right-hand corner of the screen.
5. On screen 1/4 confirm the advisory messages 1. Make sure that no patient is
connected. and 2. Connect the O2 supply. with the Next button.
6. On screen 2/4 confirm the advisory message 3. Make sure that the breathing
circuit is disconnected. with the Next button.
The system test is then started. Its progress is indicated by a bar on screen 3/4.
7. When prompted Seal the gas outlet., seal the device port to which the
breathing circuit is to be connected.
The test result is displayed on screen 4/4.
8. To exit, touch the Finish button in the bottom right-hand corner of the screen.
29375
A
30184
B
5. On screen 1/4 confirm the advisory messages 1. Make sure that no patient is
connected. and 2. Connect the O2 supply. with the Next button.
6. On screen 2/4 confirm the advisory messages 3. Connect the appropriate
breathing circuit. and Open the gas outlet. with the Next button.
The system test with breathing circuit is then started. Its progress is indicated by
a bar on screen 3/4.
7. When prompted Seal the patient port., seal the patient port.
The test result is displayed on screen 4/4.
8. To exit, touch the Finish button in the bottom right-hand corner of the screen.
6.3.3 Troubleshooting
WARNING
Risk of patient injury
If the system test or system test with breathing circuit was not completed
successfully, the ventilator is not ready for operation.
► Never use a ventilator that is not ready for operation.
Do not breathe on the CO2 sensor during zero calibration, otherwise the
procedure may fail or may be performed with an invalid zero value.
29375
A
33175
5. Touch the button CO2 zero calibration (B).
The CO2 zero calibration can be canceled at any time by touching the
X button in the top right-hand corner of the screen.
Shortly after connecting the CO2 sensor, the zero calibration may take longer
(up to 2 minutes).
30254
A
B
6. Remove the CO2 sensor (A) from the CO2 cuvette (B) of the breathing circuit.
7. On screen 1/3 confirm the advisory message Remove the cuvette from the
CO2 sensor. with the Next button.
The CO2 zero calibration starts and the message Zero calibration of CO2
sensor in progress... is displayed. A bar indicates that the calibration is in
progress.
When the CO2 zero calibration is completed, a message is displayed indicating
the result of the calibration.
8. To exit, touch the Finish button in the bottom right-hand corner of the screen.
9. Reconnect the CO2 sensor to the CO2 cuvette of the breathing circuit.
If CO2 zero calibration was not successful:
The screen displays the alarm message CO2 zero calibration failed.
● Repeat the CO2 zero calibration.
If CO2 zero calibration is still not successful:
1. Check whether the CO2 sensor is soiled, and clean the CO2 sensor if necessary.
If the sensor is faulty, replace the sensor.
2. Repeat the CO2 zero calibration.
29375
A
The CO2 filter test can be canceled at any time by touching the X button in the
top right-hand corner of the screen.
Shortly after connecting the CO2 sensor, the filter test may take longer (up to
2 minutes).
30255
A
B
6. Disconnect the CO2 sensor (A) from the CO2 cuvette and connect it to the test
filter (B).
7. On screen 1/3 confirm the advisory messages 1. Remove the cuvette from the
CO2 sensor. and 2. Attach the CO2 sensor to the test filter. with the Next
button.
8. The CO2 filter test starts and the message Filter test of CO2 sensor in
progress... is displayed. A bar indicates that the CO2 filter test is in progress.
9. When the CO2 filter test is completed, a message is displayed indicating the
result.
10.To exit, touch the Finish button in the bottom right-hand corner of the screen.
11. Reconnect the CO2 sensor to the CO2 cuvette.
If the CO2 filter test was not successful:
The screen displays the alarm message CO2 filter test failed. The measured CO2
value is outside the permissible tolerance range.
1. Check whether the CO2 sensor or the test filter is soiled, and clean it if
necessary.
2. Repeat the CO2 filter test.
7 Operation
7.1 Switching on the device
WARNING
Risk of patient injury and device malfunction
Possible health risks for patients and users.
► Use only cleaned and disinfected ventilators that have been successfully
checked as being ready for operation. For further information, see the following
chapter: "Reprocessing", page 98.
► Do not cover the device (e.g., with a blanket).
28576
A
Automatic self-test
Every time it is switched on, the device performs an automatic self-test involving a
test of the acoustic alarm signals as well as an internal device test. The device then
switches to standby mode.
The settings in the ventilation category (step 2) are preset but can be adapted.
For further information, see the following chapter: "Advanced system
setup", page 78.
The default settings for the patient category Child correspond to a child weighing
approx. 25 to 33 kg (55.1 to 72.8 lb) with a tidal volume of 6 to 8 mL per kilogram of
body weight, which corresponds to an age of 7 to 10 years.
C
A B
28236
A
B C D E
A Inspiratory oxygen concentration FiO2 (100 % O2 or O2/air mix)
B Maximum airway pressure Pmax
C Positive end-expiratory pressure PEEP
D Ratio of inspiratory time to expiratory time I:E
E Trigger sensitivity Trigger
When setting the ratio of inspiratory time to expiratory time I:E the corresponding
value Ti is automatically displayed in the notification field.
VC-AC
Volume-Controlled - Assist Control
For synchronization with the patient's inspiratory efforts. For patients with partial
spontaneous breathing.
When the trigger sensitivity is activated and set, the mandatory breaths are
synchronized with the patient's inspiratory efforts.
A low value corresponds to a high sensitivity. To adapt the trigger sensitivity to the
patient, increase the value if triggering is too easy (Autotrigger) and reduce it if
triggering is too difficult.
The actual respiratory rate may be higher than the set respiratory rate RR.
Successful patient triggering is briefly indicated by an asterisk (*) in the middle of
the waveform field at the top.
28237
A
1. Touch the More settings button.
2. Select the therapy control Trigger (A). The therapy control changes color,
turning yellow.
3. Set the desired value.
4. Confirm the set value. The therapy control changes color, back to green.
The ventilation mode VC-AC is displayed on-screen.
28239
C
A B
1. Adjust the following parameters using the therapy controls:
A Respiratory rate RR
B Tidal volume VT
2. Press the More settings button (C) and adjust the following parameters and
settings:
30161
A
G F
B C D E
A Inspiratory oxygen concentration FiO2 (100 % O2 or O2/air mix)
B Maximum airway pressure Pmax
C Positive end-expiratory pressure PEEP
D Inspiratory time Ti
E Trigger sensitivity Trigger
F Pressure rise time Slope
G Pressure support ∆Psupp
Successful patient triggering is briefly indicated by an asterisk (*) in the middle of
the waveform field at the top.
When setting the respiratory rate RR or the inspiratory time Ti the corresponding
value I:E is automatically displayed in the notification field.
VC-SIMV/PS
The following parameters can be adjusted on-screen in addition to the parameters
of ventilation mode VC-SIMV:
– Pressure support ∆Psupp above PEEP (G)
– Pressure rise time Slope (F)
The parameter Slope can only be changed when a value > 0 mbar has been set for
∆Psupp:
– Flat slope = slow pressure rise
– Medium slope = medium pressure rise
– Steep slope = rapid pressure rise
38283
C D
A B
1. Adjust the following parameters using the therapy controls:
A Inspiratory pressure Pinsp
B Positive end-expiratory pressure PEEP
2. Tap the More settings button (C) to open the settings screens.
3. On the Basic settings screen (E) adjust the following parameters and settings:
38287
A
E
B C D
A Inspiratory oxygen concentration FiO2 (100 % O2 or O2/air mix)
B Maximum airway pressure Pmax
C Respiratory rate RR
D Inspiratory time Ti
When setting the respiratory rate RR or the inspiratory time Ti the corresponding
value is automatically displayed in the notification field I:E.
4. On the Additional settings screen (F) adjust the following parameters and
settings:
38292
A
E
B C D
A Non-invasive ventilation NIV (On or Off)
B Pressure support ∆Psupp
C Trigger sensitivity Trigger
D Pressure rise time Slope
The pressure rise time Slope affects the stroke of PC-BIPAP and the pressure
support ∆Psupp if a value of > 0 mbar is set for ∆Psupp:
– Flat slope = slow pressure rise
– Medium slope = medium pressure rise
– Steep slope = rapid pressure rise
WARNING
Risk to the patient due to hypoventilation
There is a risk of hypoventilation when using CPAP for patients with insufficient
spontaneous breathing.
► Only use CPAP for patients with sufficient spontaneous breathing.
C
A B
28242
A B
C D E
A Inspiratory oxygen concentration FiO2 (100 % O2 or O2/air mix)
B Non-invasive ventilation NIV (On or Off)
C Pressure support ∆Psupp
D Trigger sensitivity Trigger
E Pressure rise time Slope
SPN-CPAP/PS
The following parameters can be adjusted on-screen in addition to the parameters
of ventilation mode SPN-CPAP:
– Pressure support ∆Psupp above PEEP (C)
– Trigger sensitivity Trigger (D)
– Pressure rise time Slope (E)
The parameter Trigger can only be changed when a value > 0 mbar has been set
for ∆Psupp.
The parameter Slope can then be changed:
– Flat = slow pressure rise
– Medium = medium pressure rise
– Steep = fast pressure rise
WARNING
Risk of patient injury
In the ventilation category CPR the minute volume and respiratory rate alarms are
not available.
► Only use the ventilation category CPR for reanimation.
28239
C
A B
1. Adjust the following parameters using the therapy controls:
A Respiratory rate RR
B Tidal volume VT
2. Press the More settings button (C) and adjust the following parameters and
settings:
28238
A
B C D
A Inspiratory oxygen concentration FiO2 (100 % O2 or O2/air mix)
B Maximum airway pressure Pmax
C Positive end-expiratory pressure PEEP
D Ratio of inspiratory time to expiratory time I:E
28235
By means of the control panel
28174
A
28235
7.5 Non-invasive ventilation (NIV)
Using NIV
NIV is available for the device in the pressure-controlled ventilation mode
SPN-CPAP or SPN-CPAP/PS. In this ventilation mode NIV is the default setting.
In the pressure-controlled ventilation mode PC-BIPAP NIV is also available, but it is
not the default setting.
The device automatically adjusts to the requirements of non-invasive ventilation.
Mask leakage is detected by the device and compensated for. This means that the
leakage for the displayed measured values VTe and MVe has already been taken
into account. The leakage alarm is not available.
WARNING
Risk of patient injury
If NIV is not active, leakage during ventilation will corrupt the VTe and MVe
measured values.
► Special care must be taken when using non-invasive ventilation.
► After activating and deactivating NIV, check the alarm limits for MVe.
WARNING
Risk of undetected leakage and inadequate ventilation
The leakage alarm is not available when using non-invasive ventilation.
► Make sure that NIV is not activated for intubated patients.
WARNING
Risk of CO2 rebreathing
Bacteria filters, HMEs, catheter mounts, and masks increase the resistance and
dead space of the breathing circuit.
► Note the manufacturer’s directions.
WARNING
Risk of aspiration
A high airway pressure may lead to aspiration.
► Avoid high airway pressure.
Deactivating NIV
1. In the ventilation mode SPN-CPAP or SPN-CPAP/PS touch the More settings
button.
In the ventilation mode PC-BIPAP touch the More settings button followed by
the Additional settings button.
2. For NIV, touch the Off button and confirm.
The adjunct NIV is hidden in the on-screen ventilation mode field, and in the
ventilation category the mask symbol is replaced by a tube symbol.
33313
2
)ORZ
/PLQ
2 I)ORZ3DZ
33314
2
)ORZ
/PLQ
2 I)ORZ3DZ
33315
2
)ORZ
2 I)ORZ3DZ /PLQ
33316
2
)ORZ
2 I)ORZ3DZ /PLQ
WARNING
Risk of patient injury
Strictly observe the following information regarding toxic and infectious
environments:
► The patient must be ventilated with an inspiratory oxygen concentration of
FiO2 100 % O2 or 93 % O2 so that toxic and infectious constituents cannot enter
the breathing gas.
► The patient must immediately be transferred to a breathable atmosphere in
order to prevent inhalation of toxic and infectious air when spontaneous
breathing resumes.
► Use a bacteria filter.
28576
A
WARNING
Risk of patient injury
The patient will no longer be ventilated if the start/standby key is held for at least
8 seconds.
► Only force a device shutdown if no patient is connected to the device or the
patient no longer needs to be ventilated.
8 Alarms
8.1 Safety information
Position of user relative to alarm system
The alarm system is designed so that the user can recognize alarm messages from
a distance of 1 m (39 in).
The specified values for the alarm volume apply to a distance of 1 m (39 in).
Warning
High-priority alarm
● The alarm indicator flashes red.
● The alarm message is highlighted by 3 prefixed exclamation marks and a red
background.
● The acoustic alarm signal consists of 5 tones, repeated twice about every
6 seconds.
Caution
Medium-priority alarm
● The alarm indicator flashes yellow.
● The alarm message is highlighted by 2 prefixed exclamation marks and a yellow
background.
● The acoustic alarm signal consists of 3 tones, repeated about every 8 seconds.
Note
Low-priority alarm
● The advisory message is highlighted by a prefixed exclamation mark and a
cyan-colored background.
● The acoustic alarm signal consists of 2 tones, sounded only once.
29398
A B
– The LED flashes red (A) when a high-priority alarm is active and yellow (B) when
a medium-priority alarm is active.
29399
– The alarm message is displayed in the middle of the screen at the top, and is
color-highlighted (B). When several alarms are active simultaneously, the alarm
with the highest priority is displayed.
– The acoustic alarm signal sounds.
When an alarm is triggered by a measured value, the measured value in question
also lights up red or yellow according to the alarm priority.
When the cause of an alarm has been eliminated, the acoustic alarm signal stops
and the alarm message disappears.
All active alarms and the alarm history can be viewed in the logbook. For further
information, see the following chapter: "Logbook", page 86
WARNING
Risk of alarms being not heard
The use of the alarm silence key may cause alarms to go unnoticed.
► Regularly check the screen for alarm messages.
28174
A
● Touch the (A) key.
The alarm indicator remains active and all current acoustic alarm signals are
silenced for about 2 minutes. The LED in the yellow key field remains lit during this
time.
New alarms with a higher priority than that of the silenced alarms override the alarm
tone suppression and, thus, are indicated by a one-time acoustic alarm signal.
After the 2 minutes, all acoustic alarm signals are reactivated and the LED in the
yellow key field goes out.
To be notified of new acoustic alarm signals during the alarm silencing, the
2-minute alarm suppression must be reset.
28579
A
28580
E
B
C
D F
2. The following settings can be made depending on the selected options:
– For the respiratory rate RR: Upper alarm limit (B)
– For the minute volume MVe: Upper alarm limit (B) and lower alarm limit (D)
– For end-tidal CO2 concentration etCO2 if the CO2 sensor
cable is connected: Upper alarm limit (B) and lower alarm limit (D)
The current value is displayed between the alarm limits (C).
Further settings:
– Alarm volume Alarm volume (E)
This enables the alarm volume to be in a range from 25 % to 100 %. The
minimum volume level can be set, see page 81. This setting then applies to all
alarms.
– Automatic setting Autoset (F)
This enables the upper and lower alarm limits to be set automatically. This
applies to all parameters.
9 Configuration
9.1 Setting configuration parameters
To access the configuration dialog:
28582
A
Standby mode
1. To move to screen 2 of the dialog, touch the button 1 in the top right-hand corner
of the screen.
2. Touch the button System setup (A).
Operation mode
1. To access the screen where the ventilation mode can be selected, touch the
X button in the top right-hand corner of the ventilation dialog.
Alternatively: Press the start dialog key on the control panel.
2. To move to screen 2 of the dialog, press button 1 in the top right-hand corner of
the screen.
3. Touch the button System setup (A).
28683
B C D
E F
G H
In the configuration dialog the following information can be displayed and changed:
– Screen brightness (B)
– 25 %, 50 %, 75 %, 100 %
– Breathing circuit (C)
– Disposable, Reusable
– HME (D)
– On, Off
– Ventilation (volume) (E) (option)
– VC-CMV, VC-SIMV
– CO2 cuvette (F) (option)
– Disposable, Reusable
Operating systems that use Bluetooth may not all be compatible with one
another.
WARNING
Risk due to incorrectly transferred data
All data that are sent via the device's MEDIBUS.X interface to other devices may be
incorrect or incomplete when displayed there. Consequently, they are used only for
information purposes.
► Do not use data displayed on other devices for diagnostic or therapeutic
decisions.
► Do not use data displayed on other devices for patient monitoring or device
monitoring.
33188
A
To take a screenshot:
● Press the screenshot button (A).
The screenshot is taken automatically and the Screenshot saved message is
displayed briefly below the ventilation category to confirm that the screenshot has
been saved.
The saved screenshots can be exported using the USB port.
29387
A
Standby mode
1. To move to screen 2, touch the button 1 in the top right-hand corner of the
screen.
2. Touch the button Advanced system setup (A).
Operation mode
During ventilation the Advanced system setup button is grayed out.
The following screens are intended for service personnel, and are password-
protected to prevent unauthorized adjustment. For further information, see the
following chapter: "Password", page 128.
33059
B C D
E F G
H I J
In the advanced system setup the following settings can be displayed and changed:
– Language (B)
– Date (C)
– Time (D)
– Demo mode (E)
– On, Off
– Export data (F) (option)
– Change password (G)
– Device settings (H)
– Ventilation settings (I)
– Restore factory settings (J)
9.9.1 Language
Here any of the languages programmed into the system can be selected. When the
new language is confirmed, the device switches to it immediately.
9.9.2 Date
29388
A B C
Day, Month and Year must each be confirmed individually with the rotary knob.
Then all the settings must be confirmed with OK, or can be discarded with Cancel.
9.9.3 Time
29389
A B
Here the system time of the device can be displayed and set.
– Hours (A)
– Minutes (B)
– OK and Cancel (C) buttons to save or cancel the time setting.
Hours and Minutes must each be confirmed individually with the rotary knob.
Then all the settings must be confirmed with OK, or can be discarded with Cancel.
WARNING
Risk of patient injury
The demo mode changes the tidal volume.
► Never activate demo mode while a patient is connected.
WARNING
Risk of patient injury and damage to the device
Do not connect a USB cable to the USB port. The voltage may cause damage to
the device or harm the patient.
► Only connect USB flash drives to the USB port.
WARNING
Unauthorized access to the system setup
If the password is not changed, unauthorized individuals have access to the system
setup and can change important settings.
► Change the preset password before the ventilator is used for the first time.
33060
2. Enter the new four-digit code. Touch the relevant buttons, set the new digits, and
confirm.
3. After entering all of the digits, touch the Next button.
4. Enter the password again.
On the last dialog page the change of the password is confirmed with the
Password changed. message. If both entries of the new password were not
identical, the Password not changed. error message is displayed.
33061
A B C
D E F
On dialog page 1/2 the following device settings can be displayed and changed:
– Breathing circuit (A)
– Disposable, Reusable
– HME (B)
– On, Off
– Pressure unit (C)
– cmH2O, mbar
– CO2 cuvette (D)
– Disposable, Reusable
– Gas supply (E)
– 100 % O2, 93 % O2
– CO2 unit (F)
– mmHg, Vol%, kPa
– Buttons Back, Next and Finish (G) for navigating within the dialog.
33062
H I
J K L
D
On dialog page 2/2 the following system settings can be displayed and changed:
– Alarm volume (H)
– 25 %, 50 %, 75 %, 100 %
– Min. alarm volume (I)
– 25 %, 50 %, 75 %, 100 %
– Screen brightness (J)
– 25 %, 50 %, 75 %, 100 %
– Screenshots (K)
– On, Off
– Bluetooth (L)
– On, Off
– Buttons Back, Next and Finish (D) for navigating within the dialog.
WARNING
Risk of patient injury
When using several ventilators in the same environment of use, the ventilation
settings must be the same on all ventilators to prevent risk of patient injury.
► Make sure that all ventilators have the same ventilation settings and alarm
settings.
Start mode can be selected on the first two dialog pages of the ventilation settings.
33065
33066
A
33068
A B
C D
The preset alarm setting values are listed in the following table:
The preset alarm volume values are listed in the following table:
All values set by the user will be overwritten by the factory settings. This cannot
be undone.
29396
A
Standby mode
1. Touch the button 1 in the top right-hand corner of the screen to go to screen 2.
2. Touch the button Logbook (A).
Operation mode
1. To access the start dialog, touch the X button in the top right-hand corner of the
ventilation dialog.
Alternatively: Press the start dialog key on the control panel.
2. Then touch the button 1 in the top right-hand corner of the screen to go to
screen 2.
3. Touch the button Logbook (A).
33072
The logbook displays all events, alarms, and the switching off of the device in
chronological order. The most recent entry is at the top. Earlier events and alarms
can be displayed using the arrow keys.
A maximum of 400 logbook entries is visible. When the capacity of the logbook is
reached, the oldest entries are overwritten. For alarms, the presence of an alarm
condition and the removal of this condition is recorded. Alarms are displayed in the
color corresponding to their priority and the removal of the alarm condition is
displayed in gray.
The entries in the logbook cannot be deleted and are preserved even after the
device is switched off and on or after a power supply failure.
29643
A
Standby mode
1. Touch the button 1 in the top right-hand corner of the screen to go to screen 2.
2. Touch the button System information (A).
Operation mode
1. To access the start dialog, touch the X button in the top right-hand corner of the
ventilation dialog.
Alternatively: Press the start dialog key on the control panel.
2. Touch button 1 in the upper right-hand corner of the screen to go to screen 2.
3. Touch the button System information (A).
38399
B C D
11 Troubleshooting
11.1 Alarm – Cause – Remedy
The alarm messages are displayed in the message field of the header bar in
hierarchical order.
The priorities of the alarm messages are indicated by different background colors.
In the "Messages in the alarm message field" table, the priorities of the alarm
messages are also indicated by exclamation marks.
In order to classify the alarms within an alarm priority, internal priorities are
specified in the table below. The lower the number, the higher the priority.
The alarm messages are listed in the following table. If an alarm occurs, the table
helps to identify causes and remedies. The different causes and remedies should
be worked through in the order listed until the alarm has been resolved.
Some alarms appear in this table several times with different priorities because their
priority may change under certain conditions.
12 Reprocessing
12.1 Disassembly
Removing the breathing hose from the device
33412
A
CAUTION
Damage to the device
The breathing hose may tear or be damaged if it is removed incorrectly.
► Always hold the sleeve (A), never the folds (B), when removing the breathing
hose from the device.
30172
B
A C D
33250
B
E
A C
3. Disconnect the pressure sensor (A) from the breathing valve (B).
4. Carefully disconnect the pressure measuring line (C) from the pressure
sensor (A).
5. Disconnect the elbow (D) from the pressure sensor (A).
6. Disconnect the breathing hose (E) from the breathing valve (B).
30171
B
E
C
A
C
3. Disconnect the flow sensor (A) from the breathing valve (B).
4. Carefully and evenly disconnect the flow measuring line or the pressure
measuring line (C) from the flow sensor (A).
CAUTION
Damage to the device
The flow sensor may be damaged when disconnecting the flow measuring line
or the pressure measuring line from the flow sensor ports.
► Never twist the flow measuring line or the pressure measuring line and do not
exert force on them.
30169
A
30170
C
WARNING
Risk of CO2 rebreathing
An incorrectly assembled or malfunctioning breathing valve may put the patient at
risk.
► Do not remove, damage, or bend the rubber disk (C) in the housing.
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
► Observe the hygiene regulations and reprocessing regulations of the healthcare
facility.
► Observe national hygiene regulations and reprocessing regulations.
► Use validated procedures for reprocessing.
► Reprocess reusable products after every use.
► Observe the manufacturer's instructions for cleaning agents, disinfectants and
reprocessing devices.
WARNING
Risk of patient injury
Disposable products have been developed, tested, and manufactured for single use
only. Disposable products must not be reused, reprocessed, or sterilized.
► Reuse, reprocessing, or sterilization may lead to a failure of the accessory and
may cause injury to the patient.
CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with
reprocessed products.
► Check the products for signs of wear and replace them if necessary.
Classification Definition
Non-critical Components that come into contact with intact skin only
Semi-critical Components that carry breathing gas or come into con-
tact with mucous membranes or pathologically altered
skin
Critical Components that penetrate skin or mucous membranes
or come into contact with blood
Surface disinfection
Components Product name Manufacturer Contact time Concentration
Device, O2 Dismozon Plus Bode Chemie 15 minutes 1.6 %
hoses, acces-
sories bag, belt
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
► Ensure that no liquid penetrates the device.
12.8 Assembly
– Reassemble the device using the information in section "Assembly and
preparation" on page 33 as a guide.
– Connect to the power supply and gas supply using the information in section
"Assembly and preparation" on page 33 as a guide.
– Check readiness for operation using the information in section "Getting started"
on page 47 as a guide.
13 Service
13.1 Safety information
WARNING
Risk due to inappropriately reprocessed products
The product may be contaminated with infectious agents.
► Before service is performed and before the product is sent back for repair,
reprocess the product in accordance with the chapter "Reprocessing".
WARNING
Risk if service is not performed regularly
Wear and material fatigue on the components may lead to device failure and
malfunctions.
► Perform service activities at the specified intervals.
WARNING
Risk if service is not performed properly
Personal injury and property damage may occur if service is not performed
properly.
► Service must be performed by those target groups that are assigned to the
particular measure.
WARNING
Risk when the housing is being opened
Under the housing there are live electrical components, which may cause an
electric shock.
► The housing may only be opened by those target groups that are assigned to
that particular measure.
13.3 Inspection
Measure Interval Target group
Inspection and safety check Every 2 years Service personnel
(Oxylog VE300 and CO2 sensor)
Safety checks
Safety checks are not a substitute for maintenance, which includes the preventive
replacement of wearing parts as specified by the manufacturer.
Performing the safety checks
1. Check that the respective instructions for use are present.
2. Observe the instructions for use and check that all components and accessories
needed to use the product are present.
3. Check that the product is in good condition:
– All labels are complete and legible
– There is no visible damage
4. Check the electrical safety in accordance with the IEC 62353 standard.
5. Check the safety equipment:
– Functioning of the safety valve: max. pressure 90 mbar (90 cmH2O)
– Functioning of the emergency air valve
– Functioning in the event of a failure of the external power supply
– Check of the second alarm channel
– Monitoring of the supply pressure and the tightness of the compressed gas
port with the standard connector
– Display of the high airway pressure alarm message
– Display of the breathing circuit error alarm message
– Check of the power supply displays
6. Perform the system test with the breathing circuit as described in the instructions
for use.
7. Check the flow dosage.
8. Check flow measurement.
13.4 Maintenance
Component Interval Measure Target group
Dust filter Every 2 years Replace 1) Service personnel
Battery – Every 2 years Replace Service personnel
– When the bat-
tery's duration of
operation is no
longer reached2)
1) The dust filter can be treated as household waste.
2) For more information on the duration of operation, see the "Technical Data" chapter.
CAUTION
Risk of patient injury
Soiling caused by dust may compromise the functional integrity of the device.
► Do not use the ventilator without a dust tilter.
13.5 Repair
Dräger recommends that all repairs are carried out by DrägerService and that only
original Dräger parts are used.
WARNING
Risk of patient injury
Never operate a ventilator if it has suffered physical damage or seems to be
working incorrectly.
► In this case, always have maintenance performed by specialized service
personnel.
14 Disposal
14.1 Disposal of the product
At the end of its useful life, dispose of the product in accordance with the applicable
legal provisions.
WARNING
Risk of explosion and of chemical burns
Improper handling of batteries can result in explosions and chemical burns.
► Do not throw batteries into fire or open them by force.
15 Technical data
15.1 Safety information
WARNING
Risk of patient injury and damage to the device
The device may not function properly or may fail outside the specified ambient and
supply conditions.
► Only use the device under the specified ambient and supply conditions.
Weight
Main device, without battery approx. 3.3 kg (7.3 lb)
Main device, with battery approx. 3.6 kg (7.9 lb)
Main device, with carrying sys- approx. 5.6 kg (12.4 lb)
tem, with battery and bag
Nominal weight with carrying sys- 10 kg (22.1 lb)
tem, battery, bag, 2-liter oxygen
cylinder, pressure reducer and
breathing circuit
Permitted total weight 13 kg (28.7 lb)
Power supply unit approx. 0.6 kg (1.3 lb)
DC/DC converter approx. 0.6 kg (1.3 lb)
Screen
Technology TFT color screen
Size 4.3 in
Resolution 480 x 272 pixels
External ports
USB 2.0
Only connect passive storage media, i.e. devices
that do not have a separate power supply.
Sound-pressure level
Average sound pressure level ≤45 dB(A)
Leq(A) (free-field measurement
at a distance of 1 m in accor-
dance with ISO 3744 and during
typical ventilation)
Sound pressure level L(A) of the approx. 47 to 83 dB(A) depending on alarm
alarm signals (measured in priority
accordance with IEC 60601-1-8)
UMDNS code
Universal Medical Device 18-098
Nomenclature System - nomen-
clature for medical devices
GMDN code
Global Medical Device 36289
Nomenclature
Battery
15.4 Settings
Using the therapy controls the values can be adjusted without loss of accuracy. The
controlled parameters pressure, flow and volume can only be applied with the
accuracy of the corresponding measured value.
Flow measurement
Minute volume MVe
Display range 0 to 100 L/min, BTPS
Resolution 0.1 L/min
Accuracy ±20 % of measured value or ±0.4 L/min,
whichever greater
Tidal volume VTe
Display range 0 to 5000 mL, BTPS
Resolution 1 mL
Accuracy ±20 % of the measured value or ±20 mL,
whichever greater (adult breathing hose)
Disposable cuvette:
NOTE: Measurement uncertainty increases at
temperatures <0 °C (+32 °F).
–20 to -10 °C: < ±(0.7 kPa + 22 % relative)
(–4 to +14 °F: < ±[5.3 mmHg + 22 % relative])
–10 to 0 °C: < ±(0.44 kPa + 13 % relative)
(+14 to +32 °F < ±[3.3 mmHg + 13 % relative])
0 to +40 °C: < ±(0.44 kPa + 8 % relative)
(+32 to +104 °F: < ±[3.3 mmHg + 8 % relative])
+40 to +50 °C: < ±(0.60 kPa + 5 % relative)
(+104 to +122 °F: < ±[4.5 mmHg + 5 % relative])
Total system response 200 ms
time
Waveform display
Airway pressure Paw (t) 0 to 90 mbar (0 to 90 cmH2O)
Flow (t) -150 to 150 L/min
CO2 0 to +100 mmHg / 0 to +15 Vol% /
0 to +15 kPa
15.7 Monitoring
Expiratory minute volume MVe (option)
Alarm, upper alarm limit If the upper alarm limit has been exceeded
Setting range 2 to 60 L/min
Alarm, lower alarm limit If the value has fallen below the lower alarm limit.
Setting range 0.5 to 40 L/min
Alarm delay 40 seconds after the start of ventilation
Apnea
Alarm If no breathing phase change is detected for
>15 seconds
Respiratory rate RR
Alarm, upper alarm limit If the upper alarm limit has been exceeded
Setting range 10 to 99 /min
Alarm delay 30 seconds after the start of ventilation
Leakage
Alarm Only with Plus option in VC modes and deacti-
vated NIV in CPAP: If VTe <45 % of VTi
Alarm delay 30 seconds after the start of ventilation
Disconnection
Alarm If a disconnection of the breathing circuit is
detected
Alarm delay 30 seconds after the start of ventilation
Battery
Alarm For low and discharged battery
Alarm delay ≤1 minute after the device start or after discon-
nection of the power supply
DC/DC converter
Protection class (as defined in Class II
IEC 60601-1)
Degree of protection IP 42
Input 12 / 24 / 28 VDC; 5 A / 2.5 A / 2.1 A
Output 19 V / 2.6 A
The intended use of the DC/DC converter is in
vehicles.
Fuse Type: FP1 MINI Style PCB
Voltage: 32 VDC / 10 A
Breaking capacity: 1000 A / 32 VDC
Operating speed: fast-acting
Gas supply
From a central gas supply system or an oxygen
cylinder
Oxygen supply pressure 270 to 690 kPa (39.16 to 100.08 psi)
Supply gas Medical oxygen, oxygen 93 %
Connection to the oxygen either:
supply NIST (Non-Interchangeable Screw-Threaded) as
per EN 739 / ISO 5359 or
DISS (Diameter Index Safety Systems) as per
CGA V5-1989 or
NF (Norme franҫaise) S90-116
Specific quick-coupling port
NOTICE
► All Dräger breathing hoses are not made with natural rubber latex.
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WARNING
Risk of patient injury and device malfunction
The use of accessories which are not included in the list of accessories as well as
converters and cables which are not sold by Dräger as spare parts may increase
electromagnetic emissions and compromise the immunity of the device.
► Only use the accessories, converters, and cables indicated by the manufacturer.
► Other accessories may only be used if they do not compromise the
electromagnetic compatibility.
WARNING
Risk of patient injury and device malfunction
If the device is used in the direct vicinity of other devices, patients may be harmed
or the device may be damaged.
► Only use the device in the direct vicinity of other devices if Dräger has approved
this device arrangement.
► If no approval has been given by Dräger, ensure that this device functions
correctly in the desired arrangement before use.
► Observe the other devices’ instructions for use.
Emissions Compliance
Radiated emissions Class B, group 1 (30 MHz to 1 GHz)
Conducted emissions Class B, group 1 (150 kHz to 30 MHz)
16 List of accessories
16.1 List of accessories
Part name Order number
Main device 57 90 200
Software options
(Plus, pressure support, data export, CO2, PC ventilation) 57 05 500
Power cable:
Germany 18 24 481
Denmark 18 68 950
United Kingdom 18 44 369
Australia 18 51 705
Switzerland 18 44 377
USA 18 41 793
China 18 59 706
Thailand 18 68 160
Brazil 18 75 523
Israel 18 69 833
Saudi Arabia 18 68 152
Argentina 18 86 274
Catheter mounts:
ErgoStar CM 40 MP 01 840
ErgoStar CM 45 MP 01 845
ErgoStar CM 50 MP 01 850
ErgoStar CM 55 MP 01 855
NIV masks:
NIV face mask ClassicStar SE, single-patient use, size S MP 01 573
NIV face mask ClassicStar SE,single-patient use, size M MP 01 574
NIV face mask ClassicStar SE, single-patient use, size L MP 01 575
NIV face mask NovaStar SE, reusable, size S MP 01 579
NIV face mask NovaStar SE, reusable, size M MP 01 580
NIV face mask NovaStar SE, reusable, size L MP 01 581
17 Password
17.1 Password protection
The following areas are password-protected in order to prevent unauthorized
adjustment:
– Advanced system setup
– Service menu
The Service menu area is accessible only to service personnel. The user cannot
make any changes here. For additional information on the service menu, see
page 108.
Area Password
Advanced system setup 4623
WARNING
Unauthorized access to the system setup
If the password is not changed, unauthorized individuals have access to the system
setup and can change important settings.
► Change the preset password before the ventilator is used for the first time. For
further information, see the following chapter: "Changing the
password", page 80
Index
A C
Accessories Carrying system
Safety instruction . . . . . . . . . . . . . . . . . . . 12 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 34
Accessories bag . . . . . . . . . . . . . . . . . . . . . . 35 Technical data . . . . . . . . . . . . . . . . . . . . 110
Advanced system setup Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Changing the password . . . . . . . . . . . . . . 80 Catheter mount
Data export setting . . . . . . . . . . . . . . . . . . 80 Connecting . . . . . . . . . . . . . . . . . . . . . . . . 45
Date setting . . . . . . . . . . . . . . . . . . . . . . . 79 CO2 cuvette
Demo mode . . . . . . . . . . . . . . . . . . . . . . . 80 Connecting . . . . . . . . . . . . . . . . . . . . . . . . 45
Device settings . . . . . . . . . . . . . . . . . . . . . 81 Disassembling . . . . . . . . . . . . . . . . . . . . . 98
Language setting . . . . . . . . . . . . . . . . . . . 79 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 109
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . 78 Reprocessing . . . . . . . . . . . . . . . . . . . . . 104
Time setting . . . . . . . . . . . . . . . . . . . . . . . 79 Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Ventilation settings . . . . . . . . . . . . . . . . . . 82 CO2 sensor
Alarm message . . . . . . . . . . . . . . . . . . . . . . . 88 Connecting . . . . . . . . . . . . . . . . . . . . . . . . 45
Alarm priorities. . . . . . . . . . . . . . . . . . . . . . . . 88 Disassembling . . . . . . . . . . . . . . . . . . . . . 98
Alarms Reprocessing . . . . . . . . . . . . . . . . . . . . . 104
Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Color concept
Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Dark green . . . . . . . . . . . . . . . . . . . . . . . . 32
Indication . . . . . . . . . . . . . . . . . . . . . . . . . 70 Gray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Messages . . . . . . . . . . . . . . . . . . . . . . . . . 88 Yellow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Cause . . . . . . . . . . . . . . . . . . . . . . . . . 88 Connected devices
Remedy . . . . . . . . . . . . . . . . . . . . . . . . 88 Safety instructions . . . . . . . . . . . . . . . . . . 12
Presettings . . . . . . . . . . . . . . . . . . . . . . . . 84 Contraindications . . . . . . . . . . . . . . . . . . . . . . 8
Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Control elements . . . . . . . . . . . . . . . . . . . . . . 28
Remedy . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Safety instructions . . . . . . . . . . . . . . . . . . 12 D
Silencing . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Determining the pneumatic duration of
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
B Device malfunction . . . . . . . . . . . . . . . . 92, 108
Bacteria filter Disinfectants
Connecting . . . . . . . . . . . . . . . . . . . . . . . . 45 Safety instructions . . . . . . . . . . . . . . . . . . 14
Bluetooth Disinfectants, information . . . . . . . . . . . . . . 101
Activating . . . . . . . . . . . . . . . . . . . . . . . . . 76 Duties of the operating organization
Pairing . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Safety instructions . . . . . . . . . . . . . . . . . . 11
Breathing circuit
Connecting . . . . . . . . . . . . . . . . . . . . . . . . 41 E
Disassembly . . . . . . . . . . . . . . . . . . . . . . . 98
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 109 Electromagnetic compatibility . . . . . . . . . . . . 12
Reprocessing . . . . . . . . . . . . . . . . . . . . . 104 EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 EMC Declaration . . . . . . . . . . . . . . . . . . . . . 121
Breathing circuits Environments of use . . . . . . . . . . . . . . . . . . . . 8
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . 21 External power supply
DC/DC converter . . . . . . . . . . . . . . . . . . . 36
Power supply unit. . . . . . . . . . . . . . . . . . . 37
G Oxygen
Safety instructions . . . . . . . . . . . . . . . . . . 13
Gas supply
Oxygen cylinder
Central gas supply . . . . . . . . . . . . . . . . . . 39
Requirements. . . . . . . . . . . . . . . . . . . . . . 33
Central gas supply by quick-coupling port 40
Safety instructions . . . . . . . . . . . . . . . . . . 13
External oxygen cylinder . . . . . . . . . . . . . 38
Oxygen fittings
Safety instructions . . . . . . . . . . . . . . . . . . 37
Safety instructions . . . . . . . . . . . . . . . . . . 13
H P
High-frequency energy
Password . . . . . . . . . . . . . . . . . . . . . . 108, 128
Emission and reception . . . . . . . . . . . . . 122
Performance characteristics . . . . . . . . . . . . . . 9
HME
Pneumatic diagram . . . . . . . . . . . . . . . . . . . 120
Connecting . . . . . . . . . . . . . . . . . . . . . . . . 45
Precautionary statements . . . . . . . . . . . . . . . 10
Product labels
I Safety instruction . . . . . . . . . . . . . . . . . . . 11
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Protection bar variants . . . . . . . . . . . . . . . . . 33
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Instructions for use R
Safety instruction . . . . . . . . . . . . . . . . . . . 10 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Reprocessing
Internal battery Classifications . . . . . . . . . . . . . . . . . . . . 101
Changing during ventilation . . . . . . . . . . . 36 Information . . . . . . . . . . . . . . . . . . . . . . . 101
Charging . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Reprocessing list . . . . . . . . . . . . . . . . . . . . . 104
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 109 Restoring factory settings . . . . . . . . . . . . . . . 85
Inserting . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Risk of infection
Maintenance . . . . . . . . . . . . . . . . . . . . . . 107 Safety instructions . . . . . . . . . . . . . . . . . . 14
Removing . . . . . . . . . . . . . . . . . . . . . . . . . 35
Safety information. . . . . . . . . . . . . . . . . . . 14
IT networks . . . . . . . . . . . . . . . . . . . . . . . . . 123 S
Safety checks . . . . . . . . . . . . . . . . . . . . . . . 107
L Safety information
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
List of accessories . . . . . . . . . . . . . . . . . . . . 125
Product-specific . . . . . . . . . . . . . . . . . . . . 15
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Safety instructions . . . . . . . . . . . . . . . . . . . . . 10
Screen
M In the event of alarms. . . . . . . . . . . . . . . . 29
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 107 Operation mode . . . . . . . . . . . . . . . . . . . . 29
Materials used . . . . . . . . . . . . . . . . . . . . . . . 119 Standby mode . . . . . . . . . . . . . . . . . . . . . 30
Messages Screenshot
Alarm message field . . . . . . . . . . . . . . . . . 88 Activating the function . . . . . . . . . . . . . . . 77
Notification field . . . . . . . . . . . . . . . . . . . . 96 Taking. . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
System test. . . . . . . . . . . . . . . . . . . . . . . . 97 Selecting and setting . . . . . . . . . . . . . . . . . . . 32
Modifications Canceling . . . . . . . . . . . . . . . . . . . . . . . . . 32
Safety instruction . . . . . . . . . . . . . . . . . . . 11 Service
Monitoring Safety instruction . . . . . . . . . . . . . . . . . . . 12
Safety instruction . . . . . . . . . . . . . . . . . . . 11 Safety instructions . . . . . . . . . . . . . . . . . . 14
Surface disinfectant. . . . . . . . . . . . . . . . . . . 103
Symbols
O
Safety instruction . . . . . . . . . . . . . . . . . . . 11
O2/air mix. . . . . . . . . . . . . . . . . . . . . . . . . 48, 84 System information . . . . . . . . . . . . . . . . . . . . 87
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . 66
Open-source software . . . . . . . . . . . . . . . . . 124
T
Target groups
Description . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended users . . . . . . . . . . . . . . . . . . . . . . 9
Technical data
Ambient conditions . . . . . . . . . . . . . . . . . 112
Device specifications . . . . . . . . . . . . . . . 110
Displayed measured values . . . . . . . . . . 115
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . 116
Operating data . . . . . . . . . . . . . . . . . . . . 118
Performance data . . . . . . . . . . . . . . . . . . 114
Safety information. . . . . . . . . . . . . . . . . . 110
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . 113
Technical documentation . . . . . . . . . . . . . . . 108
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
V
Ventilation mode
Changing . . . . . . . . . . . . . . . . . . . . . . . . . 63
Preparing . . . . . . . . . . . . . . . . . . . . . . . . . 55
Selecting . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Setting for "Ventilation" category . . . . . . . 75
Ventilation modes
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ventilation parameter
Presettings . . . . . . . . . . . . . . . . . . . . . . . . 84
View
Carrying system, bottom. . . . . . . . . . . . . . 21
Carrying system, right side . . . . . . . . . . . . 20
Main device, front . . . . . . . . . . . . . . . . . . . 19
Main device, rear . . . . . . . . . . . . . . . . . . . 18
Main device, upper side . . . . . . . . . . . . . . 17
Manufacturer
Á9054926iÈ
9054926 – GA 5503.350 en
© Drägerwerk AG & Co. KGaA
Edition: 5 – 2017-12
Dräger reserves the right to make modifications
to the device without prior notice.