User Manual MV200 - 2nd Edition
User Manual MV200 - 2nd Edition
User Manual MV200 - 2nd Edition
MV200
USER MANUAL
TESM.941144.001-01 UM
1 INTRODUCTION
Simplicity of control, functional design of the device, graphical display module allowing to set it
under the optimum angle provide convenience of operation.
The device is equipped with the built-in respiratory mixture flow generator (analogue of the tur-
bine) and does not need sources of the compressed air. For connection to the high pressure
oxygen line the device is equipped with the pneumatic socket. The built-in oxygen sensor
measures oxygen concentration in the respiratory mixture and allows controlling operation of
the air-oxygen mixer of the device.
The device can have the version allowing operation with sources of low pressure oxygen. In this
case it has the special low pressure oxygen input.
At emergency case (absence of oxygen) the device provides ventilation only with air. Due to its
design the device can operate even at the minimum pressure in oxygen system of the hospital,
taking away all possible oxygen from the line. Therefore deviations in FiO2 regulation are possi-
ble.
1-1
1.1 Intended use
The device is equipped with the touch color display 12.1” where measured data in the form of
figures and graphs (waveforms) and all information necessary for the ventilation control are dis-
played.
Special fastening of the display on the electronic unit surface allows to change the viewing an-
gle and fully fold the display (so the operating surface of the display lies on the plane of the
base unit) during storage and transportation of the device in order to avoid mechanical damage.
Controls of the device are the rotated regulator (encoder), the touch screen and functional con-
trol buttons. They provide fast and convenient access to the control parameters, registered
monitoring information (trends). Control buttons are made using touch technology (“touch-
screen”). In particular, set parameters of the current mode of ventilation are touch control but-
tons, they become active by pressing.
To avoid the accidental or inadvertent change of ventilation parameters in the device are ap-
plied:
• The three-stage scheme of applying of changes (activation, change, and confirmation). It is
necessary to confirm with special action application of the changed parameter;
• Function of the screen blocking that can be operatively switched on by the user.
For warming and moistening of the respiratory mixture the humidifier with the set of consu-
mables is needed. Please pay attention that humidifier is not included in the basic delivery set.
If necessary artificial ventilation of lungs can be carried out with the heat and moisture exchang-
ing filter that also is the part of the device delivery kit. The temperature of the respiratory mixture
is displayed on the humidifier; ways of displaying depends on the humidifier model.
The delivery kit of the device can contain adult, child reusable and/or disposable breathing cir-
cuits.
The device is equipped with the expiration valve with the electromagnetic mechanism operated
by the ventilation controller. The expiration valve has the small lag effect that does not exceed 5
ms and provides necessary dynamics of pressure maintenance in the breathing circuit. The ex-
piration valve has the removable part containing flow sensor and transmitting system of meas-
ured pressure to the device.
The membrane and the removable part of the expiration valve with the flow sensor have direct
contact with air exhaled by the patient, except the breaching circuit. These elements shall be
sterilized before using on the new patient. The membrane and the expiration valve are made
from the materials allowing sterilization by autoclaving.
The device kit contains the circuit holder (supporting arm) that provides a big range of attitudes
and allows to place conveniently the breathing circuit.
The device can be equipped with the mainstream CO2 sensor, its connection to the circuit is
made via the special airway adapter connected as close as possible to the endotracheal tube.
The device with the mainstream CO2 sensor can have optional function of the volume capnome-
try. This function allows to measure amount of carbon dioxide exhaled by the patient, and also
to define volume of the functional dead space and volume of alveolar ventilation.
Optionally the device can be equipped with the built-in module of the metabolism parameters
assessment, operating on methods of the sidestream oximetry and mainstream capnometry.
The device can incorporate two oxygen sensors. One quite slow measures oxygen concentra-
tion in the inspiratory flow (always exists) and the second is special high-speed sensor for the
assessment of the oxygen concentrations gradient at the inspiration and the exhalations.
The device has function of the automatic calibration of the main oxygen sensor without stopping
ventilation. Also 2 precision flow sensors are used in addition for measurement and control of
concentration О2 in the inhaled gas mixture.
Electrochemical oxygen sensor is used as the main.
1-2
1.1 Intended use
The high-speed oxygen sensor operates consistently with the sidestream oximetry module with
the same drained gas sample, and it measures the difference of oxygen concentrations in inspi-
ratory and expiratory phases of the respiratory cycle.
Pulse oximeter also can be the part of the device. In this case the delivery kit contains the pulse
oximetry sensor of clip type (or another on special order).
Flow and pressure sensors are placed inside the device and do not need any special lines for
the operation. Inspiratory flow sensors are separate for air and oxygen that allows managing
oxygen concentration independently of the technical condition of oxygen sensors. The expirato-
ry flow sensor is structurally placed in the expiration valve behind the membrane. Calibration of
the expiratory flow sensor is carried out without stopping of ventilation. Pressure measurement
in respiratory ways is made by means of two independent pressure sensors embedded in elec-
tronic unit.
The device can contain the additional pressure measurement channel where the measurement
catheter can be connected, for example, catheter for the pressure measurement in the trachea
or in the esophagus.
The transport cart (mobile trolley) with the handle for movement and five wheels are the part of
the basic kit. The wheels of the cart have clamps. Standard way of use of the device is installa-
tion of the electronic unit and the humidifier on the transport cart. However, operation without
the transport cart is also possible. The electronic unit of the device is equipped with handles for
its carrying, at removal from the transport cart.
1-3
1.2 General guidance
This information is necessary to know for proper and efficient use of the
device and to avoid its damage.
The Triton Electronic Systems Ltd. holds responsibility for reliability and operational characteris-
tics of the device only if:
• service and installation of the device are carried out by specialists of Triton Electronic Sys-
tems Ltd or personnel passed special training and authorized by Triton Electronic Systems
Ltd on carrying out of these works;
• the mains power meets the requirements of national standards;
• ventilator is used in accordance with current User Manual.
Reusable consumables have limited service life. Various operation conditions, cleaning, disin-
fection and sterilization can lead to the deterioration and the corresponding reduction of their
service life. At appearing of visible signs of deteriotation (cracks, deformation, decolouration,
paint detachment etc.) it is necessary to replace the consumables with the new.
Contacts:
Manufacturer
Triton Electronic Systems Ltd.
Legal address 9 Shevchenko str., of. 217, Ekaterinburg, 620027, Russia
Production site address 12/5 Sibirskiy Trakt str., Ekaterinburg, 620100, Russia
Customer service phone +7 (343) 304-60-51
Post address P/b 522, Ekaterinburg, 620063, Russia
Е-mail [email protected]
Website http://www.treat-on.com
Authorized Representative in EU Otto-Selzer Straße 16, D-97340 Marktbreit, Germany
Wladimir Wollert Tel.: +49 9332 5994095
E-mail: [email protected]
1-4
1.3 Symbols and references
Caution!
Serial number
Date of manufacture
Manufacturer
Authorized representative in EU
Alternative current
The button calling the menu window, cancellation of parameter set, menu exit etc.
Additional oxygen inlet for connection to the low-pressure oxygen source (optional)
1-5
1.3 Symbols and references
Equipotentiality
Ethernet Connector for the local information network by the standard Ethernet protocol
Port for connection of the catheter for auxiliary external pressure monitoring
Port for connection of water trap and sampling line of metabolism measurement module
Output port of metabolism measurement module (is used for elimination of the gas sam-
ple to the atmosphere)
Battery condition symbol (level of filling is proportional to the energy, green - at a charge,
yellow - at a discharge, red blinking - at the faulty accumulator)
Icons
1-6
1.3 Symbols and references
Oxygenation
Standby mode
Suction
Leak compensation
Screen lock
Graphs
PCО2 Capnogram
Oxigram for operating with the metabolism measurement module (calculated as the dif-
PО2
ference FiO2 - EtO2)
SpO2 Photopletismogram
1-7
1.4 Information about resource of the main functional units of the device
1.4 Information about resource of the main functional units of the device
The device has the built-in flow generator providing its independence from sources of com-
pressed air. The design and completing units provide guaranteed operability of the built-in flow
generator during at least 40 000 operating hours, or during the whole period of operation of 10
years (the smallest parameter is chosen). Operability of the built-in flow generator is guaranteed
only at following operating and service conditions stated in the present document.
For the monitoring of oxygen concentration in the inhaled air the device has the built-in electro-
chemical oxygen sensor with the operation resource at least 10 thousand hours.
For the service control the device has the special operating time counter. After 6 000 operating
hours the message appears at the screen of the device “Carry out maintenance”. The engineer
who has carried out maintenance should enter the command in the service menu “Reset time
after maintenance” then the time counter will return to the starting position.
1.5 Revision history
Every version of User manual has its number and date of issue. Version number is changed
with the significant technical changes of the device. When issuing new version, date of version
is also changed. Insignificant amendments and additions that don’t influence on the modes,
functions and parameters of ventilator, don’t cause the change of version date.
1-8
2.1 Basic parameters and characteristics
2 DESCRIPTION OF DEVICE
1 General features
Controlled and assisted artifical ventilation
of lungs at the patients depending on
hardware ventilation in resuscitation units,
1.1 Intended use surgery and intensive care departments of
professional medical facilities, and also at
transportation within professional medical
facilities.
1.2 Modes of operation Adult, pediatric
1.3 Display Touch, color, 12.1 inches
Electrical power
1.4 Mains 100 - 250 V, 50/60 Hz
Built-in accumulator 10-27 V
1.5 Maximum power consumption not more than 300 VA
1.6 Operation mode setup time Maximum 15 sec
Time of full ventilation when powered on internal ac- Not less than 240 minutes at any ventilator
1.7
cumulator at mains power failure settings
Dimensions of enclosure, width х height х depth
1.8 electronic unit maximum 450х450х650 mm
electronic unit installed at the mobile trolley maximum 600х600х1450 mm
Weight
1.9 electronic unit maximum 20 kg
electronic unit installed at the mobile trolley maximum 35 kg
Input oxygen pressure Operation from a high pressure
1.10 0.15 - 0.6 MPa (1.5 - 6 bar)
oxygen sources
1.11 Operation from a low pressure oxygen sources 0 - 0.005 MPa (0 - 0.05 bar)
Accuracy of the mixer when regulating the oxygen
concentration in the gas mixture
1.12
- in the range 21-60% 3%
- in the range 61-100% 6%
1.13 Trigger system of the device Flow and pressure triggers
Function of saving and viewing of trends of the main Available
1.14 monitoring parameters.
The duration of trend 240 hours
External: provide humidification and heat-
1.15 Humidifier
ing of respiratory gas mix
Built-in, pneumatic
1.16 Nebulizer
Optional: external, ultrasonic micro-pump
The synchronization of the nebulizer with the begin-
1.17 Available
ning of the patient’s inspiration
Noise level at operation of the device up to 43 dBA
1.18
Corrected sound power level up to 51 dBA
2 Ventilation modes
Continuous mandatory ventilation with the controlled
2.1 volume of inspiration (synchronized ventilation with CMV/VCV
volume control)
2-1
2.1 Basic parameters and characteristics
2-3
2.1 Basic parameters and characteristics
5 Alarms
Automatic detection of alarm conditions.
5.1 Three levels of alarm with visual and audible alarm Sound and visual form, explanatory text
message with the alarm priority (high, me-
dium, low)
5.2 Disconnection of the patient Available
5.3 Apnea Available
5.4 Occlusion Available
Vexp max 0 – 6000 ml
5.5 High/low Vexp
Vexp min 0 – 6000 ml
MVmax 1 – 60 lpm
5.6 High/low minute volume
MVmin 0 – 59 lpm
5.7 Low accumulator charge Available
5.8 Low/high О2 concentration 1 - 50 % from the set value
5.9 Pmax is reached Pmax: 10 -105 cmH2O (mbar)
1
RB max 2 - 120 /min
5.10 Low/high respiratory rate RB 1
RB min 1 - 119 /min
5.11 Low O2 pressure Available
5.12 No mains voltage Available
5.13 Low/high EtCO2 2 - 12 % (15 - 100 mmHg)
5.14 Low/high SpO2 60 - 95 % / 90 - 100 %
1 1
5.15 Low/high PR 15 - 100 /min / 80 - 350 /min
Classification
The device is designed for continuous operation in accordance with IEC 60601-1.
Regarding safety the device complies with IEC 60601-1, ISO 80601-2-12, ISO 80601-2-55, ISO
80601-2-61. The device is classified as class I type of protection (when powered from mains)/from internal
power supply (in the absence of connection to the mains) with applied part of type B and applied part of
type BF (pulse oximetry sensor).
According to electromagnetic compatibility the device complies with IEC 60601-1-2.
The enclosure of device has degree of protection against penetration of water and solids particles
IP21 (enclosure is protected against ingress of particles with a diameter of at least 12.5 mm and falling
drops of water falling vertically).
The device has the parts and accessories to be autoclaved by steam (see Section 3.5).
Note:
Control ranges of some ventilation parameters in certain modes of ventilation and with “child” type of
the patient may differ from the written above.
2-4
2.2 Configuration of device
2 Filter-regulator
TESM.186143
for connection of the device to the compressed
oxygen.
4 Oxygen hose
TESM.046002-01 for connection of the unit to
the cylinder or the distribution system of com-
pressed oxygen of medical facility.
5 Basket
TESM.189014 for storage of the accessories.
Mounted on transport cart (option).
2-5
2.2 Configuration of device
17 Catheter
for measurement of auxiliary pressure in trachea
(TESM.046502) and esophagus (stomach)
18 Power cable
for connection of the ventilator to the mains power
19 Spare parts:
2-7
2.2 Configuration of device
19.1 Fuse
T2.0AL/250V 5×20 mm (2 pieces) to replace the
fuse in the power plug in case of their failure.
19.2 Microfilter
TESM.189017 for the replacement in the filter -
oxygen pressure regulator
19.3 Membrane
TESM.236501 for the replacement in the expira-
tion valve
19.6 Ring
TESM.049124 for the replacement in the screwed
cap of filter-regulator for connection to the “O2” in-
let port.
2-8
2.3 Front panel
2-9
2.3 Front panel
1. Swivel panel 14. “Insp” port is intended for connection of the inspiratory
line of the breathing circuit.
2. Swivel panel support 15. “Paux” port for connection of external auxiliary pres-
sure monitoring catheter.
3. Touch screen 16. “SpO2” connector for the pulse oximetry sensor.
4. “Alarm” indicator is used for additional attraction of at- 17. Rubber legs of the device.
tention. It flashes red when the alarm is triggered.
5. Button of temporarily mute of the audible alarm. Green 18. Fixing bolt of the electronic unit to the transport cart.
LED means that audible alarm is off.
6. Button “Menu” in intended for entering the device’s 19. Water trap for the removing of fluid from the exhaust
control menu. valve.
7. Button “?” is intended for displaying of delayed alarms 20. “EXHAUST” port for the elimination of the patient's ex-
window. haled gas to the atmosphere.
21. “Exp” port for connection of the expiratory line of the
8. Button (“Functions”) is intended for displaying of breathing circuit.
the menu of additional functions, including nebulizer.
9. Manipulator (encoder) for the control of the device. 22. Output port of metabolism measurement module for
elimination of the gas sample to the atmosphere.
10. Bottom part of the device. 23. Handles for carrying of the device.
11. Turn on/off button (to turn off – hold down for 3-5 24. Port for connection of the line from pneumatic nebuliz-
seconds). er.
12. “Battery” LED. It indicates the condition of the accu- 25. “СO2” connector for the mainstream capnometer.
mulator charger:
- green - accumulator is being charged;
- off – the accumulator is fully charged;
- flashing yellow – less than 10 minutes left of opera- 26. Water trap for connection of sampling line for metabol-
tion from the accumulator; ism measurement module (optional)
- red – charger malfunction.
13. “Power” LED. It indicates the power supply:
- green – device is connected to the mains
The surface of the liquid crystal display of device should be protected from
impacts and other mechanical effects in order to avoid the appearance of
unevenness, scratches, and damage of the touchscreen and display.
2-10
2.4 Rear panel
1. Power switch (in “O” position fully disconnects the device from the mains supply voltage)
2. Cooling fan filter
3. Communication interface socket (Ethernet)
4. USB-port for connecting of the external USB-flash memory
5. Equipotential terminal (potential balancing)
6. Filter-regulator with the port for connection of the device to the oxygen source
7. Water trap of the filter-regulator
8. Fresh gas intake filter
9. Connector for the low pressure oxygen line
10. Metal bracket for prevention of accidental disconnection of the power cord
11. Mains fuses holder
a) b)
1. Installation table
2. Bracket for fixing of the supporting arm (circuit holder)
3. Handle
4. Panel for installation of the additional equipment
5. Mounting bracket for humidifier
6. Chassis
7. Swivel wheel with brake
8. Swivel wheel
9. Openings for installation (1 pc.) and fixing (2 pcs.) of the electronic unit.
10. Basket for storage of the accessories (the balloon holder can be mounted instead
2-12
3.1 Operating conditions
3-1
3.2 Safety precautions
• The operation of the device is allowed only under the supervision of qualified medical per-
sonnel able to provide immediate care to the patient and, if necessary, to ensure alternative
methods of ventilation in case of device’s malfunction!
• During ventilation always use a bedside monitor providing a complete and independent con-
trol of the vital parameters of the patient. Leaving the patient unattended be sure that the
sound alarm the device is enabled.
• While using the device on the patient keep ready the alternative means of ventilation (for ex-
ample, the spare ventilator).
• While using the device on the patient periodically check the patient condition and proper ven-
tilator function, e.g. on-time data updating on the screen.
• Ventilation with dry gas after 10 minutes can cause damage of the ciliary epithelium of the
trachea and bronchi and subsequent evaporation from the surface of the alveoli. Do not allow
prolonged ventilation without heating and moistening the gas supplied to the patient.
• In case of any emergency situation during of the operation (fire, short circuit, etc.), imme-
diately disconnect the device from the patient and continue to ventilate the patient in other
ways. Pull out the power cord from the wall outlet or turn off the device by power switch (Fig-
ure 2.2, position 1). Disconnect the pressure of compressed oxygen.
• On the rear panel of the device in the mains block there are fuses of T2.0AL/250V type (2
pcs.). Do not replace the fuse without disconnecting the device from the mains.
• Operation of the device at the removed cover powered from mains is prohibited.
• Disinfection of the switched on device is prohibited (the power plug must be removed from
the socket).
• Immersion of electrical connectors of sensors, cables etc. into liquid disinfectant solutions is
prohibited.
• The operation the device may affect equipment in the vicinity, for example, high-frequency
electrosurgical devices, shortwave therapy equipment, cell phones. Do not use the device in
the operating conditions of the nuclear magnetic resonance equipment.
• The barometric pressure is compensated by ventilator during measurements with main-
stream CO2 sensor and metabolism measure module.
• During operation high oxygen concentration are used, so it is necessary to perform the fol-
lowing safety rules:
o Use only the breathing circuits intended for use in the enriched oxygen environment.
Do not use antistatic or conductive hoses and tubes in the breathing circuit.
o Connection to the oxygen line is allowed only through regular oxygen filter-regulator
supplied with the device and mounted on the rear of the cap nut with seal.
o Do not allow oxygen leakage in the place of connection of the filter-regulator to the
compressed oxygen source.
o Do not use the device together with the explosive anesthetics.
o Do not use the device near equipment containing industrial oils.
o Do not use the device if the oxygen hose is damaged or contaminated with industrial
oils.
o Periodically inspect the filter located in the water trap reservoir of the oxygen regula-
tor. If contaminated immediately replace it with the supplied spare filter.
o Remove the condensate from the water trap through the valve at the bottom part of
the regulator. Do not disassemble the regulator under pressure!!!
o When handling with oxygen cylinders comply with the local safety regulations. Al-
ways check the status of the gas cylinders before using.
3-2
3.2 Safety precautions
• Multiple cleaning or sterilization and re-use of disposable accessories are prohibited. This
can cause equipment malfunction and harm to the patient.
• Dispose the packing materials from accessories including packing from disposable accesso-
ries according to your national standards and your facility’s guidelines for waste disposal.
• During operation the ventilator should be securely fixed on the cart in three points with sup-
plied bolts and nut.
• When placing the device on the transport cart increased tilting danger in case of:
o placing or moving the cart on sloped floors;
o pulling the cart over obstacles like doorsteps;
o heavy items leaning against the cart;
o equipment and accessories mounted outside the center of gravity.
• Do not lean against the cart.
• When placing the device with the transport cart on an inclined plane, swivel wheels with
brakes must be located from below to prevent the device from sliding.
• Be careful during transportation the device on the transport cart. Hold the cart handle with
both hands when moving to prevent tipping.
3-3
3.3 Preparing for operation
• Before putting into operation clean and disinfect the device and its components in accor-
dance with it. 3.5.
Figure 3.1 – Installation of the electronic unit on the table of the cart
3-4
3.3 Preparing for operation
Secure the electronic unit to the cart with the supplied butterfly nut and additional attachments on
the other side (figure 3.2).
Make sure that the ventilator is properly fixed on the cart in three points to
prevent injuries of the patient caused by falling of electronic unit from the
cart.
After preparing the device for use, lock the cart wheels to prevent injuries of
the patient and personnel, and damage of the device.
• Install the supplied supporting arm (the circuit holder) on either side of the cart according to
Figure 3.3. Place breathing circuit on the supporting arm in a form convenient for use.
• The arm is equipped with self-locking buttons (see Figure 3.4) for changing the seg-
ments position. For the arm folding, press and hold the button to unlock the segment,
select the desired segment position, then release the button to lock it. It is not neces-
sary to press the button for the arm lifting, just pull the segment upward.
3-5
3.3 Preparing for operation
Note:
1. Use humidifiers recommended by the manufacturer.
2. When using the humidifier follow the its operation manual.
3. When using the humidifier the active humidification method is applied.
3-6
3.3 Preparing for operation
Table 3.1. The list of recommended circuits for different types of humidifiers
Figure
Humidifier
VADI Medical Humidifiers MR810, MR850
Circuit Technology Fisher & Paykel Healthcare
Breathing circuit
type Co. Ltd, Tai- Ltd, New Zealand
wan
w/o humi-
VH-2000 MR810 MR850
difier.
Adult/Pediatric
KD-“MS-1” Medsilicon Ltd, Russian Fed-
eration patient circuit, reusable, adult / reusable 3.7 3.9 - 3.6
pediatric
Adult
038-01-155B Flexicare Medical Ltd, UK disp. 3.7 3.9 - -
5009 Intersurgical Ltd, UK disp. 3.7 3.9 - -
RT206 Fisher & Paykel Healthcare Ltd,
disp. - - 3.8 3.6
New Zealand
038-31-768 Flexicare Medical Ltd, UK disp. - - 3.8 3.6
RT105 Fisher & Paykel Healthcare Ltd,
disp. - - 3.8 3.6
New Zealand
038-01-163 Flexicare Medical Ltd, UK disp. - - 3.8 3.6
900МR784 Fisher & Paykel Healthcare
reusable - - 3.8 3.6
Ltd, New Zealand
Pediatric
038-02-155B Flexicare Medical Ltd, UK disp. 3.7 3.9 - -
5513 Intersurgical Ltd, UK disp. 3.7 3.9 - -
4504810 Intersurgical Ltd, UK disp. - - 3.8 3.6
5504810 Intersurgical Ltd, UK disp. - - 3.8 3.6
Neonatal
038-03-315 Flexicare Medical Ltd, UK disp. 3.7 3.9 - -
4510 Intersurgical Ltd, UK disp. 3.7 3.9 - -
RT225 Fisher & Paykel Healthcare Ltd,
disp. - - 3.8 3.6
New Zealand
038-03-304С Flexicare Medical Ltd, UK disp. - - 3.8 3.6
3-7
3.3 Preparing for operation
Figure 3.6 – Assembly of the disposable or reusable breathing circuit with humidifier MR850 with
the heated hose and temperature sensor
Note:
At the extreme necessity at the discretion of the physician the short-term operation without
the humidifier is allowed. In this case assemble circuit according to the Figure 3.7. Use the
passive humidifier, i.e. recommended heat-moisture exchange (HME) filter.
3-8
3.3 Preparing for operation
Figure 3.8 – Assembly of disposable or reusable breathing circuit with humidifier MR810
Figure 3.9 – Assembly of disposable or reusable breathing circuit with humidifier MR810, VADI VH-
2000
3-9
3.3 Preparing for operation
Figure 3.10 – Assembly of the breathing circuit with the mask for NIV (optional)
During the ventilation it is necessary to monitor the level of liquid in the wa-
ter trap chamber at the bottom part of the expiration valve and if necessary
to empty it as shown in Figure 3.11.
Figure 3.11 – Removing of the liquid from the removable water trap chamber
3-10
3.3 Preparing for operation
Using of the coaxial (or dual chamber) breathing circuit is recommended for
short-term ventilation without humidifier and with HME filter.
When using the humidifier because of design features of such circuits gra-
dual accumulation of moisture and occlusion of the breathing circuit can
occur.
3-11
3.3 Preparing for operation
Connection to the oxygen line is allowed only with the regular oxygen filter-
regulator supplied with the device.
• Connect the other end of the oxygen hose to the quick-release valves of the gas supply line
(for oxygen) using the connector DIN 13260-2, that is part of the hose.
Figure 3.14 - Connection to the central gas supply system of the hospital
• On special order the hoses can be equipped with other adapters for connection to the main
gas supply of the medical facility.
• The filter regulator is set to maintain the input pressure of the ventilator up to 2 kgf / cm2
(bar). If the pressure is less than 2 kgf / cm2 (bar), it is transmitted to the input of the device
without changes. The filter regulator at the bottom part has a semi-automatic valve for peri-
odic, when necessary, draining condensate.
The recommended operating range of the oxygen source pressure is 1.5 - 6 kgf / cm2 (bar). It is
allowed to use low-pressure oxygen sources with a pressure range of 0.5 - 1.5 kgf / cm2 (bar),
taking into account the following features:
3-12
3.3 Preparing for operation
o The mixer is designed to try to create the required oxygen flow at any input pressure. If
the oxygen flow is less than required, a lack of oxygen is replaced by air and the FiO2
parameter in the range of values greater than 50 – 60 % with values of a minute respi-
ration volume greater than 20 - 30 lpm may differ from the set one. To eliminate the
alarms for the FiO2, the FiO2 limit should be set to 40 %
o When operating with oxygen concentrator, at the time of the maximum inspiratory flow
the oxygen pressure can vary greatly, however, a significant change in FiO2 does not
occur due to the capacity of the oxygen line. To avoid low oxygen pressure alarms
(pressure drops during inspiration), turn off the low oxygen pressure alarm.
o When operating from an oxygen concentrator, its output capacity should be at least 10
lpm.
Optionally the device can be connected to a low-pressure oxygen source of less than 0.5 kgf /
cm2 (bar). For more details, see it. 5.8. For this purpose at the factory the manufacturer installs
an additional inlet oxygen fitting on the rear panel of the device.
3-13
3.4 Device turning on and off
• If the device is powered from the mains, connect the power cord to the socket on the rear
panel of the device. Insert the power cord plug to three-pole power outlet with grounding con-
tact and turn the power switch on the rear panel to position "I" (on). "POWER" indicator
on the front panel is lit green.
• When the device is connected to the mains power, "battery" indicator lights green, it means
that accumulator is charging. During the charge, towards the end of the charge, the indicator
may off for a while and then is lit green again.
• In the absence of mains supply it is allowed to operate from the backup internal or external
power supply in accordance with it. 4.2.
• If the external pressure monitoring function is available, make sure that monitoring line for
pressure measurement disconnected from the “Paux” fitting (Figure 2.1, position 15).
• To turn on the device shortly press button. The adjacent LEDs will be lit green.
• At device turning on graphical splash screen appears on the display (for 8 - 10 seconds),
start testing (initialization) of all components and electronic units is performed and short beep
signal is issued indicating the correct operation of the sound module.
3-14
3.4 Device turning on and off
• After start testing, the display shows the start screen intended for the setting of the ventilation
modes and parameters. Detailed procedure for the beginning of ventilation is described in it.
4.4.
• Device control is described in details in Section 4.
• At the first turning on or after a long break in the operation test the device in turned off condi-
tion without mains power. To do this for 4 - 5 seconds turn the power switch on the rear
panel to the position "0" (off). If during the test the device turns off, stop using the device and
contact customer service.
• At the accumulator malfunction the device can continue ventilation if there is power supply. In
this case at the start the menu window with a warning appears. If you select "Continue", the
device will continue its operation as in the normal mode, and the accumulator indicator will
flash red to symbolize the accumulator problem.
BATTERY MALFUNCTION
Urgently replace accumulator !
In case of power supply failure
ventilation can stop
without warning !
Do you agree
to continue ventilation ?
Continue
Exit to tech. failure mode
If user selects "Exit to tech. failure mode" line, window with the status of the modules will be
opened. Inform the technical experts about the information in this window for all modules of the
device.
At the operation with a faulty accumulator, failures of the mains power can
cause shutdown of the device and the termination of ventilation without any
notice. The responsibility for the negative consequences of operation of the
device with defective accumulator lies on the hospital medical staff.
• To turn the device off press the button during 5 - 6 seconds (it is protecting measure
from accidentally pressing).
• Turning the device off is accompanied by the audible signal and the characteristic sound of
the flow generator, operating for about 4 - 5 seconds at the high speed. This is done for re-
placement of oxygen mixture to the air in the breathing circuit, allowing to extend the service
life of the oxygen sensor. Overpressure in the circuit is not created.
At operating in child mode due to increased pneumatic resistance of pediatric and especially neo-
natal circuits during purging of the O2 sensor, the pressure in the tee can greatly increase, that is
dangerous for the patient. In the child mode it is necessary to disconnect the circuit from the pa-
tient and only after fixing of the disconnection to perform a purge and turn off the power.
3-15
3.5 Cleaning, disinfection and sterilization
Cleaning and disinfection of the device shall be carried out after each use
as well as before putting into operation, maintenance or sending for repair
to the manufacturer.
Avoid spilling of any liquids on the body of the device and the swivel dis-
play during operation or at the disinfection.
Clean and disinfect the external surfaces and sensor, which are not intended for sterilization,
only by wiping using gauze swab or soft cloth moistened in cleaning and disinfectant solution.
Squeeze the cloth before wiping to prevent penetration of solution into the device. Use only dis-
tilled water for cleaning and disinfection solution preparation.
Recommended cleaners and disinfectants
- Hydrogen peroxide solution 3% with ionic surface-active substance solution 0.5%
- Alcohol solution (ethyl or isopropyl alcohol) 70 %
- Chlorhexidine gluconate solution 0.5%
It is possible to use other certificated cleaners and disinfectants acceptable for medical use
with similar active components in proper concentration.
Cleaning and disinfection procedure
Clean the component using a gauze swab or soft cloth moistened in the mentioned above
cleaning and disinfectant solution. Follow the recommendations stated in the manufacturer’s
cleaner and disinfectant manual.
Refer to Table 3.2 for detailed information on cleaning and disinfection of ventilator’s external
parts and certain components which could be cleaned and disinfected.
For detailed description of cleaning and disinfection procedures of components manufac-
tured by third party (humidifier and accessories, nebulizer, etc.) refer to manual supplied with
component.
3-16
3.5 Cleaning, disinfection and sterilization
Table 3.2 Recommended methods for cleaning and disinfection of external parts and cer-
tain components
External parts Before cleaning and disinfection turn Ensure that ventilator is
off the ventilator and disconnect the completely dry before con-
power cord from mains socket. Fol- necting to mains socket and
low the procedures mentioned switching on.
above.
Touch screen panel Clean the touch screen with soft Do not use rough materials
cloth moist with neutral detergent with abrasive components
and then dry it with soft cloth. for wiping. Do not apply an
excessive effort when wip-
ing the touch screen, you
can damage it.
Mainstream CO2 Disconnect connector of the sensor Before start the monitoring
sensor from the ventilator; disconnect the ensure that optical windows
ventilation adapters from the sensor. of the sensor are complete-
Clean and disinfect the external sur- ly dry and clean, no stains
faces of the sensor including optical from solution or water
windows according to procedures drops.
mentioned above. For reprocessing
of reusable ventilation adapters refer
to p. 3.5.2.
Pulseoximeter sen- Disconnect the connector of sensor
sor from the ventilator. Clean and disin-
fect the external surfaces of the
sensor according to procedures
mentioned above.
3-17
3.5 Cleaning, disinfection and sterilization
Do not use rough brushes, sharp tools and abrasive materials for manual
cleaning!
Reprocessing procedure
1. Remove the component from the ventilator and dissemble it if it is possible.
2. Clean and disinfect the component in accordance with recommendation below.
3. Check the component for defects.
4. Assemble the component according to assembling scheme.
5. Put the component into special package for autoclaving.
6. Sterilize the component in autoclave in accordance with recommendation below.
7. Ensure that packaged component is completely dry after sterilization.
8. Store the component into the package. The hold time after sterilization depends on used
packing, refer to packing manual.
9. After connecting the component to ventilator make all necessary testing and calibration.
Cleaning and disinfection
a) Manual cleaning and disinfection
Recommended cleaners and disinfectants
Cleaners:
- Ionic surface-active substance solution 0.5%
- Neutral soap solution
- Neodisher Mediclean forte 1 %, manufactured by Dr. Weigert
Disinfectants:
- Lysetol AF и Gigasept FF, manufactured by Schülke & Mayr
- Sekusept PLUS, manufactured by Henkel-Ecolab
- CIDEX, manufactured by Johnson & Johnson or gluteraldehyde solution with concentration
≤ 3.6 %
It is possible to use other certificated cleaners and disinfectants acceptable for medical use
with similar active components in proper concentration.
Cleaning
1. Remove the component from the ventilator and dissemble it if it is possible.
2. Wash and soak the component in warm solution (temperature below 40°C) of the rec-
ommended cleaner. Use the clean tray for soaking. Make sure that component is fully
soaked into solution; there are no air bubbles in holes and cavities of the component. Use
soft plastic brush for removing solid pollution from components surface. Soaking time and
cleaning method depends on used cleaner; follow the manufacturer’s manual of cleaner.
3. Wash the component under the stream of clean water or follow the manufacturer’s rec-
ommendation of the cleaner.
4. Dry component on the air
5. Inspect the component and dispose the defective one.
3-18
3.5 Cleaning, disinfection and sterilization
Disinfection
6. Disinfect the component by means of soaking in disinfection solution. Remove the com-
ponent from the ventilator and dissemble it if it is possible. Use the clean tray for soaking.
Make sure that component is fully soaked into solution, there are no air bubbles. The
soaking time and disinfection method depend on used disinfectant, follow the disinfec-
tant’s manual.
7. Dry component on the air. Do not wipe the component during drying.
a) Automated cleaning and disinfection
For automated cleaning and disinfection use the washing machine comply with ISO 15883.
As cleaning agent use Neodisher FA®, as neutralizer - Neodisher Z®, both manufactured by
Dr. Weigert. Follow the operation manual of machine and detergent as well. Recommended
regimes are stated in Table 3.3.
Disconnect the expiration valve housing from the ventilator, see it. 6.6. Clean and disinfect
all components of expiration valve housing (removable part, membrane, water trap) sepa-
rately. After cleaning and disinfection insert the membrane to removable part and assem-
ble the water trap. Sterilize the removable part with membrane and water trap separately.
Assemble the expiration valve housing by connecting the water trap to removable part with
membrane before connection to ventilator. After connection the expiration valve housing to
ventilator perform the calibration, see it. 4.16.3.
3-19
3.5 Cleaning, disinfection and sterilization
Removable part of Disconnect the water trap and mem- Before sterilization make
expiration valve brane from removable part. Repro- sure that all ports and holes
cess according to Reprocessing pro- are cleaned properly.
cedure mentioned above.
Membrane Before processing carefully separate The number of cycles is not
the membrane from the expiration less than 100 (excluding
valve seat with the uncut long object damages during operation).
(inverse part of the tweezers) After cleaning and disinfec-
through the hole "Expiration" of the tion of the membrane en-
valve. sure that metal disk is
Reprocess according to Reprocess- tightly and properly sealed
ing procedure mentioned above. into membrane. Replace
the membrane with new
one in case of defect detec-
tion.
Water trap reusable Disassemble the water trap (see fig. The number of cycles is not
3.11) by disconnection of water trap less than 100 (excluding
chamber before reprocessing. Dis- damages during operation).
pose the water from water trap Replace the water trap with
chamber. Clean and disinfect all new one in case of defect
components of water trap separate- detection.
ly. Assemble the water trap before
sterilization.
Reprocess according to Reprocess-
ing procedure mentioned above.
Patient circuit components
Disassemble the patient circuit completely. Disassemble the water traps, dispose the wa-
ter. Clean and disinfect the components of water trap separately. The general recommen-
dations on reusable circuit reprocessing are stated below, for more details follow the ma-
nual supplied with circuit.
Patient circuit tubes Autoclave at 134 °С and 0.21 MPa Roll the tubes on big diame-
reusable for 30 minutes. ter circles. Avoid kinking
and over twisting of the
tubes. Before sterilization
make sure that tubes are
completely dry.
• Patient circuit con- Autoclave at 120 °С and 0.11 MPa Replace the component
nectors for 45 minutes. with new one in case of de-
fect detection.
• Reusable patient
tee
• Water trap
Reusable airway adapters for mainstream CO2 sensor
Reusable airway Disconnect the airway adapter from The number of cycles is not
adapters for main- mainstream CO2 sensor. Repro- less than 100 (excluding
stream CO2 sensor cess according to Reprocessing damages during operation).
procedure mentioned above. After reprocessing en-
sure that adapter’s win-
dows are clean and dry.
3-20
4.1 Main features of device
4 DEVICE CONTROL
4.1 Main features of device
Device provides respiratory assistance in the following ventilation modes:
• Continuous mandatory ventilation with the controlled volume of inspiration CMV/VCV;
• Continuous mandatory ventilation with the controlled pressure of inspiration CMV/PCV;
• Synchronized intermittent mandatory ventilation with flow trigger or pressure trigger with vo-
lume control SIMV/VC with pressure support of spontaneous breaths (PS);
• Synchronized intermittent mandatory ventilation with flow trigger or pressure trigger with
pressure control SIMV/PC with pressure support of spontaneous breaths (PS);
• Synchronized intermittent mandatory ventilation with flow trigger or pressure trigger with
double control SIMV/DC with pressure support of spontaneous breaths (PS);
• Spontaneous breathing with continuous positive airway pressure CPAP with pressure sup-
port of spontaneous breaths (PS);
• Spontaneous breathing with two levels of continuous positive airway pressure BiSTEP with
pressure support of spontaneous breaths (PS) (analog of BiPAP1 mode);
• Mandatory ventilation with guaranteed delivery of target respiratory volume at minimum
possible pressure with pressure control PCV-VG with pressure support of spontaneous
breaths (PS);
• Non-invasive ventilation of lungs (unassisted breath through the mask with continuous posi-
tive airway pressure and pressure support of spontaneous breaths) NIV;
• Airway pressure release ventilation APRV;
• Intellectual support ventilation iSV;
• APNEA ventilation (emergency mode, it is triggered if respiratory standstill – apnea – is de-
tected).
Note:
Accessible ventilations modes are defined by functional equipment of the device. The de-
tailed description of ventilation modes is provided in the Appendix 1.
In the NIV mode parameters of the APNEA ventilation are displayed in the edit line and can be
changed by the user.
The device displays on the screen real data of respiratory monitoring in the form of figures and
waveforms. Graps of pressure, flow and tidal volume, the capnography and photoplethysmo-
graphy waveform (if capnometer and pulse oximeter are connected) are displayed in real time,
and also volume capnography waveform and auxiliary pressure graphs can be displayed.
The device allows the user to set the alarm thresholds for the main parameters of patient venti-
lation monitoring, and also provides the alarm at the events breaking normal ventilation (discon-
nection, occlusion, absence of mains voltage etc.).
Ergonomic design of the device, including the big touch display, one rotating control handle (en-
coder) allow the user to get fast and easy access to the control parameters, and registered
monitor information (trends).
1
Hereinafter BiPAP® is a registered trademark of "Respironics Inc"
4-1
4.1 Main features of device
The built-in accumulator allows the device to operate without interruption (at the total charge)
not less than 4 hours in case of absence of the centralized power supply at any ventilations pa-
rameters. At the minute ventilation volume of 10 lpm the device operates from the accumulator
not less than 6 hours.
The transport cart (mobile trolley) allows to move quickly the device to the necessary place, and
also to provide ventilation of the patient during intrahospital transportation.
The device can be used also without the transport cart.
The device operates with the open circuit - gas exhaled by the patient is not used repeatedly.
At installation in the breathing circuit up to 3 virus-bacterial filters pressure in the patient tee
changes no more than on 3 cmH2O, at the flow 60 lpm in case of timely replacement of filters at
their remoistening.
The device provides possibility of independent breath of the patient if normal ventilation is im-
possible because of troubles with electro - and pneumo supply. Pressure drop in the inspiration
and exhalation lines, measured in the patient connection port does not exceed 6 cmH2O.
The device can operate with oxygen sources of high and low pressure, for example with oxygen
concentrators. The device supports the declared accuracy of FiO2 only if operates from high
pressure oxygen sources. At operation from low pressure oxygen source, accuracy of FiO2 is
defined by the low pressure oxygen source.
4-2
4.2 Reserve power supply
At operation of the device from the built-in accumulator light indicator "POWER" is switched off,
and the graphic symbol of accumulator condition on the display (Figure 4.4, position 4) changes
the color from green to yellow. Furthermore, alarm signal of medium priority "No mains voltage"
is activated.
The device can operate when powered from the new completely charged accumulator not less
than 4 hours. In average conditions, at respiratory rate 15 - 20 1/min and tidal volume 500 - 700
ml (minute volume of ventilation about 10 lpm), the device can operate from completely charged
accumulator not less than 6 hours.
Level of charge of the built-in accumulator can be controlled by the graphic symbol on the de-
vice display (Figure 4.4, position 4). The figure in the centre of the symbol shows the level of the
remained charge (the maximum value 100 corresponds to completely charged accumulator).
If charge of accumulator provides less than 10 minutes of device operation, the high priority
alarm signal "< 10 min left" is activated.
At activation of the high priority alarm signal "< 10 min left" try to restore
mains supply, if it is impossible, immediately prepare other means for the
patient ventilation and be ready to use them.
The message "Accumulator is discharged" will appear on the screen of the device and the
graphic symbol of the accumulator becomes red in 2 - 3 minutes prior to switching off.
At restoration of the mains supply the device automatically changes operation to it and
ventilation modes do not change. The charge of the built-in accumulator also starts
automatically, and indicator "BATTERY" changes its color to green. The microprocessor control
system of the charger chooses the optimum current of the accumulator charge. If device is
completed with the accumulators with the charge current not less than 2.9 A, the charge of the
accumulator proceeds about 3 hours if initially it is completely discharged.
If the built-in accumulator is fully charged, indicator "BATTERY" is switched off.
When the unit is powered from external DC source, the built-in accumulator does not charge.
4-3
4.2 Reserve power supply
Fully charge built-in accumulator before every using of ventilator with the
connection to the patient.
• Device operating time in the independent mode depends on the accumulator capacity, its
previous charge level and time passed after that, quality of the accumulator, terms of its
operation, and also from the operating mode of the device.
• During long-term operation or storage there can be reduction of accumulator capacity,
therefore time of independent operation of the device can be reduced. That can not be a
reason for claims to the manufacturer.
• For the maintenance of capacity and increasing of the service life of the accumulator it is
necessary to conduct periodically its training (at least once a half a year) (see Section 6).
If the device is connected to the mains power, but the indicator “accumulator” is red, it means
that charging device and/or the accumulator are faulty and need repair. Operation of such
device is forbidden, because it does not provide possibility of operation at interruptions of power
supply.
In some cases, at malfunction of the accumulator, the device can continue ventilation in the
presence of mains supply. Also at the detection of the accumulator failure during the device
operation, ventilation does not stop, but the accumulator indicator on the screen blink with red
color.
4-4
4.3 Controls
4.3 Controls
Power control buttons:
• Button on the rear panel provides external mains power supply to the device and charger
with accumulator.
• Button on the front panel of the device is used for switching on and off the device.
• Sound alarm off button – switches off sound alarm for 2 min.
• Menu button - call of menu window, cancellation of parameter setting, exit from the
menu etc. The button is duplicated by the touch button with the same graphic designation.
• Button - call the list of delayed alarms on the log screen. The list contains earlier alarms
which reasons are eliminated. If the reason of alarm was eliminated, the sound alarm signal
disappears, however the light signal remains and demands from the user to enter into the
delayed alarm log and to familiarise with them. After that the delayed alarm log is
automatically cleared and the light alarm signal is switched off.
• Encoder – navigation on the menu items, moving of the marker on the trends,
navigation in the alarm log, parameter change (handle rotation); parameter choice/fixing,
activation of the menu item (pressing of the encoder handle).
4-5
4.4 Starting window. Beginning of ventilation
* - For modes with pressure control, instead of tidal volume Vt, target inspiratory pressure Pi is specified.
The starting window is by default set in the position "New patient". Buttons of selection of the
mode, gender, type, height of the patient and "Start ventilation" button are active. In the bottom
rectangle starting calculated parameters are shown.
The "Previous patient" button is also active, it opens the window with data of the previous
patient: the mode, gender, type, height and ideal weight, but these buttons are not active, only
"Start ventilation" button is active. Starting calculated parameters for the previous patient are not
shown.
Default parameters for the new patient:
• Adult - man, height 174 cm. Child - man, height 70 cm.
• Height control range in the pediatric mode: from 57 to 150 cm (with step of 1 cm to 100 cm, 2
cm to 150 cm).
• Weight control range in the child mode (at height < 57 cm): from 2.0 to 5.0 kg (with step of
0.1 kg).
• Height control range in the adult mode: from 130 to 250 cm (with step of 2 cm).
Height of the patient is corrected by the encoder. According to the height of the patient the ideal
body weight (IBW) is calculated. Value of ideal body weight (IBW) is the evaluated depending
on height and gender of the patient and can not be adjusted directly. The calculation procedure
of ideal body weight (IBW) is given in the Appendix 2.9. The ideal body weight (IBW) is the av-
erage value, function of height and gender and does not depend on real weight of the patient. It
is used for the estimation of target MV, inspiration volume and respiratory rate. In concept of
ideal weight there is important physiological value - people of different weight, but identical
height statistically have the close sizes of lungs. The optimum volume of the inspiration corre-
lates more with human height, than with its weight.
4-6
4.4 Starting window. Beginning of ventilation
"Start calibration" button is used to start the calibration procedure for the expiration valve. It
shall be performed every time after the replacement or sterilization of the removable part of the
expiration valve (for detailed description see 4.16.3).
4.4.2 Window of associated parameters
After pressing of "Start ventilation" button the main screen appears, and in the central part of the
screen there is the window of the ventilation associated parameters and the window of Apnea
parameters (for those ventilation modes where there is support of spontaneous breath of the
patient, see it. 4.8.2):
where:
I:E - Inspiratory:expiratory ratio
Flow - Initial flow
Texp - Expiratory time
TrigWnd - Trigger window
Tplat - Plateau time
MV - Minute volume
Ptrig - Pressure trigger sensitivity
Ftrig - Flow trigger sensitivity
Tramp - Pressure rise time relatively to Tinsp
Figure 4.2 – Window of associated parameters
Ventilation begins after pressing of the graphic button "Apply" or through 10 s, if it there are no
actions on editing of ventilation parameters.
After pressing of the corresponding "Edit" button ventilation parameters located in the bottom
line of the main screen and parameters of the apnea become available for editing. When venti-
lation parameters are adjusted, corresponding associated parameters also are changed. In
case of the conflict of parameters conflicting parameters are designated by red or yellow color.
Adjustment of ventilation parameters for each ventilation mode is described more detailed in it.
4.7.
4-7
4.4 Starting window. Beginning of ventilation
These calculations are real for a resting condition (without physical activity) for conditionally
healthy person. At the increased physical activity, at the increased body temperature, at the
raised metabolism, at the expressed pain syndrome minute ventilation can increase many
times. At the same time in the condition of the lowered metabolism (for example, under anes-
thesia, etc.), minute ventilation can decrease noticeably. Further correction of minute volume
during ventilation is carried out by the doctor, according to the information of gas composition of
blood, EtCO2 and clinical condition of the patient.
Values of calculated starting ventilation parameters are given below. These parameters are
starting, guaranteeing the safe start of ventilation.
Table 4.2. Values of the calculated starting ventilation parameters for the new patient
Parameter Value Notice
adults and children with weight more
0.1 liter per kg IBW
than 30 kg
MV 0.3 liter per kg IBW children with weight up to 5 kg
(–0.008×IBW+0.34) liter per kg children with weight from 5 to 30 kg
IBW
standard value of 7.5 ml/kg is
available to adjust in the [Menu] →
Vt 7.5 ml/kg × IBW [Ventilation parameters] → [Patient’s
parameters] in the range 6 … 9 ml/kg
IBW with the step 0.5 ml
4-8
4.4 Starting window. Beginning of ventilation
4-9
4.4 Starting window. Beginning of ventilation
4-10
4.5 Main window
2
11
12
15
14
14
13
16
Figure 4.4 - Main window
4-11
4.5 Main window
4-12
4.5 Main window
4-13
4.6 Main menu
To enter the main menu press "Menu" button on the front panel (Figure 2.1, position 6).
Each line of the menu is the touch button. For quick access to the menu item press the
appropriate line by your finger. Navigating in the menu is also made by rotation of encoder
knob, the selection of menu item is made by pressing the encoder knob. To cancel and exit
from the menu repeatedly press the "Menu" button or select "Exit".
If within 30 seconds no pressing or turning the encoder was detected, exit from the menu to the
previous menu and then to the main screen window is made automatically.
Ventilation modes Parameter calls menu of ventilation mode setting. it. 4.7
Ventilation Parameter calls the menu of general ventilation parameters
it. 4.8
parameters setting and selection of patient’s type.
Parameter allows to set type of the inspiration trigger -
Trigger type it. 4.9
pressure or flow one.
Parameter allows to set the duration of the trigger window
Trig.window in percent or seconds. Selecting the units of the trigger ---
window - in percent or in seconds.
FiO2 sensor Parameter provides the possibility to measure FiO2
it. 4.10
autocalibr. accurately at changing of external conditions.
Additional functions Parameter calls the additional functions menu. it. 4.11
Parameter calls menu of settings of graphs and measured
Display settings it. 4.12
parameters rectangles.
Trends Parameter calls the menu of viewing trends and alarm log. it. 4.13
Alarms Parameter calls the menu of alarm thresholds setting. it. 4.14
Parameter calls the menu of setting the volume of alarms
Sound volume it. 4.15
and spontaneous breath signal.
Service menu Technical menu for the service personnel. it. 4.16
Exit Return to the main window. ---
4-14
4.7 Setting of ventilation modes and parameters
After selecting of the desired mode, ventilation assosiated parameters window (see it.4.4.2) and
apnea parameters window (for ventilation modes with the support of the spontaneous breathing)
(see it. 4.8.2) will appear in the center of the display.
4-15
4.7 Setting of ventilation modes and parameters
By clicking on the graphical button "Edit" user can change the ventilation parameters at the
bottom part of the main screen (Figure 4.4, position 13), and apnea parameters (if available in
the current ventilation mode).
Start of the ventilation in the new mode occurs only by pressing the touch button "Apply" with
the set cursor on it or by pressing the encoder knob. This provides protection against
unintended changes of modes and settings of the ventilation.
If no attempts to edit the parameters were detected within 30 seconds or after pressing the
"Cancel" button the ventilator returns to the previous mode of the ventilation.
4-16
4.7 Setting of ventilation modes and parameters
Conflict of parameters:
• At the change of ventilation parameter, conflict with other parameters in the edit row or
associated parameter window can occur. Test of parameter correctness is made on the each
step of setting. For instance, increasing of respiratory rate can lead to situation when I:E is
out of allowable range with the same inspiratory time.
• The type of conflict is reflected by the color of conflicting parameter.
• Yellow color indicates a medium priority conflict. The device can take this parameter for
execution, but warns about incorrect parameter. This situation occurs when the sensitivity of
the inspiratory pressure trigger exceeds PEEP. This means that the trigger will be activated
at the negative pressure in the circuit. Also problem can occur when user selects the
decreasing flow waveform and large flows during inspiration - because of the limitation of the
peak flow in the volume modes at 100 lpm flow waveform may differ from descending,
approaching to the rectangular.
• Red color indicates a high priority conflict. The values of various parameters are mutually
exclusive. The device can not take this parameter for execution. The user must resolve the
conflict to change the mode. All ventilation modes have the same algorithm for informing
about conflict.
4-17
4.7 Setting of ventilation modes and parameters
4-18
4.7 Setting of ventilation modes and parameters
4-19
4.7 Setting of ventilation modes and parameters
that the time of expiration can be significantly longer than the time of inspiration. There is no
limitation of the expiratory time regarding the minimum I:E ratio, it can reach a value of 1:99.
• PEEP – positive end-expiratory pressure. In BiSTEP and APRV modes Plow parameter
functionally corresponds to the PEEP parameter.
• VТ – tidal volume. At changing of VТ minute volume MV and initial flow Flow are changed
simultaneously. Other parameters (respiratory rate, inspiration and expiratory time) are not
changed.
• Tinsp – inspiratory time. Changing of the Tinsp parameter is made due to expiratory time
Texp and I:E ratio and does not change the respiratory rate. Control limit of Tinsp for some
modes can be changed in [Menu] → [Ventilation parameters] → [Tinsp limit].
• Tplat – plateau time is duration of the plateau relative to inspiratory time. It is set in percent
or seconds depending on the setting of parameter [Menu] → [Ventilation parameters] →
[Plateau time].
• FormFlow – flow waveform (rectangular or decreasing).
• Ftrig (Ptrig) – flow (pressure) trigger sensitivity. Trigger sensitivity determines the minimum
value of the patient's respiratory effort required to run the algorithm of spontaneous
inspiration support. In the flow trigger [Menu] → [Ventilation parameters] there is an
additional criterion “Trigger Vinsp 25ml”, which eliminates missing of breaths with very low
rate of the flow increasing. Breath is activated by the accumulation of 25 ml tidal volume
during 0.5 s.
Do not set without a special reason very high sensitivity of the inspiratory
trigger (Ftrig < 3 lpm or Ptrig < 3 cmH2O) because it increases the probabili-
ty of autotriggering or false triggering due to movements of the circuit,
acoustic noise, patient’s movements, etc. In this case triggering will be in-
itiated by the system itself, and not by the patient.
• PS – support pressure of spontaneous breath. If the newly set inspiration support pressure
plus PEEP exceeds the maximum allowable pressure Pmax, then the PS and PEEP
background will be painted in red and the application of parameters will be forbidden. In the
BiSTEP mode PS parameter is used to support spontaneous breaths only on the low
pressure phase Plow. At high pressure phase support pressure is fixed at 5 cmH2O to
prevent barotrauma.
• Pi – inspiratory pressure. If the newly set inspiratory pressure plus PEEP exceeds the
maximum acceptable pressure Pmax, then Pi background will be painted in red and the
application parameters will be forbidden.
• Vapnea – tidal volume in the apnea mode. It is regulated similarly to VТ.
• Tapnea – time of transition to the apnea mode after detection of the respiratory arrest.
• Piapnea – inspiratory pressure above apnea PEEP level in the apnea mode.
• RBapnea – respiratory rate in the apnea mode.
• Phigh (Plow) – pressure value in the high (low) pressure phase (in the BiSTEP, APRV
modes).
• Thigh (Tlow) – time of the high (low) pressure phase (in the BiSTEP, APRV modes).
• Fsupp – support flow (base flow).
• ETS – expiration trigger sensitivity - percentage of peak inspiratory flow at which the device
switches from inspiration to expiration in the respiratory cycle with pressure support.
Increasing of parameter results in the earlier termination of inspiration and allows to complete
breath normally when there is a leakage in the circuit.
4-20
4.7 Setting of ventilation modes and parameters
• TrigWnd – trigger window or a part of the expiratory time when spontaneous breath is
expected. The expiration is divided by trigger window into two parts: 1) the time period at the
end of that hardware breath should happen, if there were no spontaneous inspiration
attempts, 2) the time period during that the spontaneous inspiratory efforts are expected and
maintained. The duration of the trigger window can be set in percent or seconds, depending
on the setting of [Menu] → [Trig.window].
• ETC – endotracheal tube compensation.
• %MV – factor of increasing/decreasing of target MV in the iSV mode.
• Adapt.MV – function of MV adaptation in the iSV mode.
• Pramp – rate of the pressure rise. This value determines the time of reaching of the target
pressure in the pressure control mode and at spontaneous inspiration support. Control range
5…200 cmH2O/s. At changing of the rate of pressure rise, the ventilator automatically
calculates the specific amount of inspiratory time that takes the phase of pressure rise and
displays it in the associated parameters window in %.
P(t)
1 2 3 Pramp1 > Pramp2 > Pramp3
Pi
PEEP
At using endotracheal or tracheostomy tubes of small diameter try to avoid high values Pramp.
Due to inadequate large initial flow and high tube resistance inspiratory pressure in the breath-
ing circuit can be achieved untimely. As a result due to the activation of the expiratory trigger,
the pressure support of spontaneous inspiration (PS) can be prematurely interrupted.
Pramp parameter determines the time when the target pressure will be reached. Optimal value
of Pramp can be determined by the shape of the inspiration pressure curve, see Figure below.
Proper selection of this parameter is essential for optimal inspiration and increases patient’s
respiratory comfort. Because of inadequate high pressure rise rate and high tube resistance,
inspiratory pressure in the breathing circuit can be achieved untimely. As a result inspiration can
be prematurely interrupted at the pressure support (PS) of spontaneous breath. Excessive small
value of Pramp can cause the patient’s feeling of the lack of air. When using endotracheal or
tracheostomy tubes of small diameter try to avoid high values of Pramp.
• Facc – Determines the rate of the initial inspiratory flow change. Parameter is used only in
NIV mode (instead of Pramp). Control range is 10…100 %.
• Plimit – value of pressure limitation in the breathing circuit in the iSV mode.
• Pmin – minimum support pressure, sets the minimum allowable value of the support pres-
sure of the spontaneous breathing by ventilator.
4-21
4.8 Menu of general ventilation parameters setting
This menu is used to set the ventilation parameters that are rarely changed: Selection of para-
meters is performed by the encoder or the touch buttons (menu bar).
Designation of
Description of parameter Values
parameter
Patient’s parameters Type of the patient adult, child
Gender male, female
Height 57…250 cm
Weight1 2.0…5.0 kg
IBW (ideal body weight)
Tube parameters:
Type (endotracheal, tracheostomy) ET, TST
Diameter (variation range is defined by IBW, see 4.5…10.0 mm
it.5.6)
Apnea parameters Calls the window of apnea parameters see it.4.8.2
iSV parameters Calls the window of iSV parameters see it.4.8.3
Pmax, Tinsp limits Allows in some modes to increase the upper limits of see it.4.8.4
the adjustment of Pmax, Tinsp
Compl.meas period Determines time between compliance and resistance 0…10 min
measurement cycles.2
Insp.end trig. ETS Trigger of the end of inspiration ETS - percentage of 5…80 %
peak inspiratory flow at that the ventilator switches
from inspiration to expiration in the respiratory cycle
with pressure support. Increasing the parameter
results in earlier termination of inspiration and allows
to complete breath normally at the leakage in the
circuit.
The NIV mode uses its own copy of the ETS
parameter that does not affect other modes.
4-22
4.8 Menu of general ventilation parameters setting
Designation of
Description of parameter Values
parameter
After exit from the NIV mode the old value of ETS is
restored. ETS in NIV is measured in lpm.
Sigh Mode of the periodic deepen sigh.3 on, off
Trigger Vinsp 25ml Additional criterion of activation of the inspiratory on, off
trigger, when inspiratory volume exceeds 25 ml. That
provides the triggering at the slow spontaneous
inspirations.
Sens. to disconn. Sensitivity threshold of device to the "Disconnection" 0…50 %
alarm. It is defined as the inspiration to expiration (step 5 %)
volume ratio expressed in percent. Alarm
"Disconnection" will be formed when the inspiration
to expiration volume ratio is below the sensitivity to
disconnection.
Plateau time Selecting of the parameter unit %, s
Т disconn.in NIV Delay time of disconnection alarm triggering in the 0…60 s
NIV mode. Default parameter value is 5 seconds.
1 – If user tries to enter a patient's height <57 cm, the ventilator goes into the patient's weight
editing mode (to the minimum value of 2 kg). The reverse transition occurs when user enters a
weight > 5 kg. At weight values between 2.0 and 5.0 kg, the iSV mode becomes unavailable
2 – Applied method of calculation of compliance and resistance is described in Appendix 2.1. To
measure compliance immediately, press the compliance window on the device’s display. That is
sensor button at the same time.
3 – Parameters of the periodic deepen sigh mode: periodicity - every 50 respiratory cycles
(inspiration), tidal volume - 1.5 times more than set one (for ventilation modes with volume
control), maximum pressure – on 5 cmH2O more than the set one (for ventilation modes with the
pressure control).
4-23
4.8 Menu of general ventilation parameters setting
4-24
4.8 Menu of general ventilation parameters setting
Designation of
Description of parameter Values
parameter
Vtmax calc. Sets the level of inspiratory volume limitation Vtmax, at that
coeff. Vtmax is calculated automaticallyVtmax = Vtmax calc. coeff. x 7 - 30
IBW, where IBW – ideal body weight (see it.4.8.1). ml per kg
(default value 22 ml per kg)
Enable IRV in Enable/disable of the inverse mode of ventilation when inspira-
off/on
iSV tion is longer than expiration (default value off).
Designation of
Description of parameter Values
parameter
Pmax limit Allows to increase the upper limit of Pmax to 105 cmH2O (line
is available only in the CMV/VCV, CMV/PCV, SIMV/VC, 87, 105
SIMV/PC, SIMV/DC, PCV/VG modes at the adult type of pa- cmH2O
tient)
Tinsp limit Allows to increase the upper limit of inspiratory time Tinsp to 10
s (line is available only in the CMV/VCV, CMV/PCV, SIMV/VC,
3, 10 s
SIMV/PC, SIMV/DC, PCV/VG modes at the adult type of pa-
tient)
4-25
4.9 Setting of the type of inspiration trigger
The trigger is intended for activation of the inspiration process when it detects patient’s attempts
to spontaneous breathing. Flow trigger is triggered, if it detects that inspiratory flow of the pa-
tient is greater than the threshold value. The pressure trigger is started when pressure drop in
the circuit caused by inhalation of the patient is greater than the threshold value.
Trigger flow is preferable because it usually allows the patient to breathe with less effort. An ad-
ditional criterion of flow triggering is the excess of the inspiration volume of 25 ml that provides
triggering at the slow spontaneous breaths.
Enter the main menu of device to set type of the inspiration trigger (see it. 4.6). This automati-
cally sets the correct sensitivity parameter Ftrig or Ptrig, which is displayed in the right window
of the set parameters area (Figure 4.4, position 13).
Designation of
Description of parameter Values
parameter
Ftrig Flow trigger sensitivity:
- child mode 0.5 …10 lpm
- adult mode 1…20 lpm
with step of 0.5 lpm*
Ptrig Pressure trigger sensitivity 0.5 …20 cmH2O
with step of 0.5 cmH2O
* - in the range up to 3.0 lpm –with step of 0.1 lpm
The sensitivity of the trigger is a parameter that determines the minimum value of the patient's
respiratory effort required to run the spontaneous inspiration support algorithm.
In the NIV mode flow trigger is not used because its operation is impossible in the presence
of leak. The algorithm of the inspiratory trigger in NIV has two simultaneous criteria:
• The first one is similar to the pressure trigger of other modes (Ptrig is limited to 10 cmH2O).
• The second one is unique for the NIV and applies only in the NIV mode. The ventilator com-
pares the flow of the patient with the same flow but delayed for 0.3 seconds. This operation
is performed by control microprocessor of the ventilator.
If the difference between the flows reachs 10 lpm, device makes a decision about detection of
spontaneous inspiration. This criterion is not susceptible to leakage and allows the device to
work reliably at unpressurized breathing circuit (mask).
An additional criterion of activation of the inspiratory trigger is excess of the inspiratory volume
of 25 ml. That allows the triggering at the slow spontaneous breaths.
In the CMV / VCV, CMV / PCV and PCV-VG modes, the flow and pressure triggers can be dis-
abled (has Off position).
4-26
4.10 Automatic calibration of the oxygen sensor
When the function is on, periodic monitoring of mismatch between the sensor readings of FiO2
and set value of FiO2 is conducted. If the mismatch is greater than the absolute value of 3 %,
the FiO2 sensor is automatically calibrated. The display shows message about the oxygen sen-
sor calibration. Calibration is performed without stopping of ventilation with the O2 level of 21 %,
so there is short-time (about 1 min) decreasing of FiO2 to 21 %. Upon completion of the calibra-
tion, FiO2 value is restored and message about the results of the calibration is displayed.
The set parameter of oxygen sensor automatic calibration is retained at the change of mode,
patient type, switching off the device.
4-27
4.11 Additional functions
PEEP increment value is set in the menu. It can be changed in the range from 3 to 25 cmH2O.
By clicking on the "Start" row, the maneuver starts and the icon changes its color to indicate the
activation of the mode.
When the procedure "Alveolar recruitment maneuver" is enabled by the operator or automatical-
ly by time, the following occurs:
• After the next inspiration new PEEP value is set equal to PEEP + PEEP incr.;
• 2 breaths are performed. Inspiration pressure in the CMV/PCV mode is equal to Pi +
PEEP incr., in the CMV/VCV mode inspiration volume is not changed;
• Returning to the initial ventilation settings. The procedure is repeated automatically after 3
minutes. Alveolar recruitment maneuver is turned off at the activation of the functions "Sigh",
"Leak compensation", "Suction".
Paw
∆PEEP
PEEP
Figure 4.7 – Paw waveform at the active phase of the alveolar recruitment maneuver
To disable the maneuver click on the "Stop" row (during procedure it replaces the row “Start”) in
the "Alveolar recruitment maneuver" submenu, the icon will change color to indicate that mode
is off. The device automatically disables the alveolar recruitment maneuver at the transition to
another ventilation mode. At the occlusion, disconnection or apnea deactivation also occurs with
subsequent recovery at the returning to the initial mode of ventilation.
4-29
4.11 Additional functions
4.11.2 Oxygenation
Activation of the function is available through [Menu] → [Additional functions] → [FiO2 100% 2
In the oxygenation mode 100 % oxygen is provided for 2 minutes. Field of oxygen concentration
setting in supplied breathing mixture becomes yellow and contains the countdown timer that
shows the time left before the end of oxygenation. At clicking on this field or icon oxygena-
tion is disabled.
4.11.3 Suction
Activation of the function is available through [Menu] → [Additional functions] → [Suction] or
icon
After activation of the function for 3 minutes "Oxygenation" is performed (see it.4.11.2). At this
time the ventilator waits for disconnecting of the patient. If the disconnection does not occur, the
device returns to the previous mode, the "Suction" function is switched off.
If disconnection occurs, the device stops ventilation. Window with the message of disconnection
and with timer showing time of its beginning appears. Operation with the interface and alarms
are blocked. The ventilator is waiting for connection of patient after suction. If connection does
not occur within 2 minutes, the device activates sound alarm.
After connection device resumes ventilation. Oxygenation is swiching for 2 minutes.
Suction can be stopped during operation by disabling "Suction" or "Oxygenation" function
through the menu or through the icon.
4-30
4.11 Additional functions
Menu allows to change the indicated ventilation parameters. At the clicking on the "Exit" item,
menu closes and the screen shows information window of standby mode.
4-31
4.11 Additional functions
When the leakage compensation function is active, the device performs the following actions:
• tidal volume is increased by the level of leakage;
• base flow (support flow) in the phase of PEEP maintenance is increased so that despite the
leakage, PEEP remains at the predetermined level.
In the ventilation modes with volume control the device adds a measured amount of leakage to
the inspiration volume set by the user VТ. However, the addition can not exceed 100 % of VТ.
This limitation minimizes the risk of harm to the patient in case of errors in the leakage determi-
nation due to technical failures or any other reasons.
When leakage compensation is disabled, base flow (support flow) of device is 10 lpm. It is ne-
cessary for the PEEP maintenance and operation of the flow trigger.
Activation of leakage compensation function automatically increases the base flow so that base
flow through the expiration valve is 10 lpm. This mechanism ensures the maintenance of PEEP
with presence of leakage and allows the normal operation of the inspiratory triggers.
The device can successfully operate up to the value of the base flow of 25 lpm with PEEP of 20
cmH2O. It allows to compensate for significant leakage. If leakage is greater, deviation from the
set level of PEEP or false activation of inspiratory trigger can occur. If this happens, check the
breathing circuit and eliminate the cause of the leakage, or fix the position of the endotracheal
tube or reduce the sensitivity of the inspiratory trigger.
Significant leakage can lead to the retention of spontaneous inspiration, due to the fact that the
inspiratory flow will not fall to the level of activation of the expiratory trigger (the trigger of the
end of inspiration). To normalize the situation set the expiratory trigger level higher than lea-
kage.
4-32
4.11 Additional functions
If necessary operator can use the face mask (mask for non-invasive ventilation) instead of the
endotracheal tube in all modes of the ventilation with leakage compensation, as the step of se-
paration of the patient from the device. A feature of this mode unlike the NIV mode is presence
of the hardware breaths.
4-33
4.11 Additional functions
fore the end of inspiration, inspiration continues to the activation of the expiratory trigger. Oth-
erwise inspiration ends when the button is released or time is passed.
In the BiSTEP mode manual breath on the Plow phase is performed as hardware breath with
pressure control with pressure Pi = PS with the current rate of pressure rise.
On the Phigh phase, if Phigh ≥ Plow + PS manual breath is not performed. If Phigh < Plow + PS
manual breath is performed by the usual rules with transition to the expiration by an algorithm
similar to CPAP+PS.
On the Plow phase manual breath is performed similarly to the CPAP+PS mode.
In the APRV mode on the Plow phase manual breath is not performed. If the button remains
pressed, at the transition to Phigh, inspiration to pressure Phigh + PS is performed.
In the APRV mode on the Phigh phase, manual breath is performed to the pressure Phigh + PS,
with transition to the expiration by an algorithm similar to CPAP+PS.
In iSV mode function “Manual Breath” is not available.
Manual ventilation
If necessary the physician can perform manual breaths with the desired frequency, thereby per-
forming the manual ventilation.
4-34
4.11 Additional functions
The activation function is performed via icon on the main screen, at the same time:
• graphic representation of the icon becomes active (dark blue);
• current scale of the graph is saved;
• the last recorded point of the curve is drawn at the end right position;
• all previous points of the curve are drawn in proportion to the left;
• vertical marker line appears on all charts, corresponding to the time of pressing the freeze
button;
• line of instantaneous values of the curves corresponding to the position of the marker line
appears above graphs;
• marker line is moved to the desired position by encoder;
• at the repeated pressing the icon, "freezing" of the curves is canceled. Current cycle begins
to draw from the random moment.
At rotating the encoder marker line moves to the left/right and accordingly to its position instan-
taneous values including time are changed. Moving the marker line can also be done by touch-
ing in the certain area of graphs. Time is counted down from the moment of pressing (eg. – 3.21
s).
mode with the icon or on the main screen of the device (Figure 4.4, position 9).
Night mode of the display is switched automatically from 24 pm to 5 am.
By clicking on the icon display mode is switched to the opposite (regardless of the time).
Brightness of the display can be adjusted through the [Menu] → [Service menu] → [Calibration]
→ [CIND] → [Day brightness] or [Night brightness]. The brightness of the day screen varies
4-35
4.12 Display settings menu
from 100 to 50 % with 10 % step. Default value is 100 %. Brightness in the night mode varies
from 100 to 30 % with 10 % step. Default value is 60 %.
4.12 Display settings menu
Enter the menu through the main menu of device [Menu] → [Display settings] (see it. 4.6).
4-36
4.12 Display settings menu
To select graph rotate the encoder, to select the desired graph push the encoder, to cancel
press the "Menu" button.
Displaying of graphs
The scale of pressure graph is selected by user of the Pmax value and in maximum case may
be -20…120 cmH2O.
The scale of the rest of the graphs is selected automatically - once for the entire period of the
sweep (at the moment of the transition of the graph through the right border), if the scale
change criterion works.
Pressure graph Paw shows:
• Marker of the maximum inspiratory pressure Pmax (blue line).
• PEEP marker (if PEEP > 0 cmН2О) (light blue line).
• Pressure curve (green or blue line, depending on the inspiration/expiratory phase).
Scale of flow rate graph is automatically selected in the range ±250 lpm, depending on the
maximum flow rate in the current mode.
All graphics display instant, current values of parameters in real time and are synchronized on
the common time base.
4-37
4.12 Display settings menu
• current loop becomes the reference at the end of the respiratory cycle;
• reference loop is fixed in grey color;
• line of reference loop fixing time is displayed.
At the repeated pressing of REF, the previous loop is selected as reference. The reference loop
is updated at every new cycle. Time line will be hidden.
In the mode of displaying of 4 curves the last selected reference loop is displayed.
Changing of the graph indication mode does not effect on the current lung
ventilation mode.
4-38
4.12 Display settings menu
Menu allows to configure the areas of additional and the main monitoring parameters displaying
(Figure 4.4, positions 1, 12).
Table 4.7. The list of monitoring parameters that can be selected in any of the displayed fields
of the screen
1. Empty No data
2. AutoPEEP Residual pressure level in lungs
3. C/R (LSF) Dinamic сompliance/resistance
4. Cst/Rst Static compliance/Static resistance
Concentration of СО2 in the exhaled mixture / Elimination of CO2 per
5. EtCO2 %/VCO2*
minute
EtCO2
6. Partial pressure of СО2 in the exhaled / inspired mixture in mmHg
mmHg/FiCO2
7. FiO2 Fractional concentration of inspired oxygen
8. fspont Frequency of spontaneous breaths
9. FlowPeak Peak inspiratory flow
10. Leak Leakage flow from the breathing circuit
11. MV/MVspont Minute volume / Minute volume of spontaneous breaths
12. MValv/Vd* Minute alveolar ventilation / Functional dead space
13. Paux Auxiliary external pressure
14. Ptp Transpulmonary pressure
Peak inspiratory pressure / Mean pressure for the respiratory cycle /
15. PIP/Pm/PEEP
Positive end-expiratory pressure
16. Pplat Plateau pressure
17. RB/I:E Respiratory rate / Inspiratory:expiratory ratio
18. Valv/Vd:Vexp* Alveolar ventilation / Functional dead space: tidal volume
19. Vexp/Vinsp Expiratory volume / Inspiratory volume
20. СO/VCO2* Cardiac output (by Fick) / Elimination of CO2 per minute
* - parameters of volumetric capnometry VCO2, Valv, MValv, Vd and cardiac output (CO) by Fick are
available only if device is equipped with mainstream capnometer, volume capnometry module and func-
tion of cardiac output.
4-39
4.13 Menu of view of trends and alarm log
• MV (minute volume);
• Tinsp (inspiratory time);
• RB (respiratory rate).
All trends are synchronized and linked to the same time point selected by the cursor on the
graph.
Moving the cursor is performed by rotating the encoder or by pressing the touch buttons at the
bottom part of the trend window. Incorrectly measured and unmeasured parameters are
displayed as gaps in the graphs and as dashes in the value field. To the right of the trend,
values at the selected moment are displayed. The bottom line displays the time and date of
recording.
Trends are cyclically recorded in non-volatile memory and restored when the power is turned
on. Duration of trends is the last 240 hours of device’s operation.
To return from the trend window to the main mode press the "Menu" button or click the
encoder.
"Edit" parameter
Using "Edit" parameter operator can set time scale of the main trends (the width of the trend
window in minutes), their number:
and displayed parameters (this menu is also available by pressing on the area of displaying
parameter values that is to the right of the area of displaying trends):
4-41
4.13 Menu of view of trends and alarm log
4-42
4.13 Menu of view of trends and alarm log
Navigation in the alarm log is performed by rotating the encoder. To exit press the "Menu"
button or the encoder. Alarms are logged cyclically. The log can hold at least 1 000 alarms. The
log is stored in non-volatile memory.
"Save alarm log" parameter records the alarm log to removable media connected to the USB-
port on the rear panel of device. Alarm log is stored in the file "AlarmJournal.csv", in csv format
with the separation character ";" in CP866 coding.
4-43
4.14 Alarm settings menu
Line of the
Designation, description of parameters Possible values Default value
menu
EtCO2_max – top alarm threshold of СО2 EtCO2_min…12
6
concentration in exhaled air [%]. %
EtCO2_min – bottom alarm threshold of СО2 2… EtCO2_max
2
concentration in exhaled air [%]. %
Change measuring units – switches unit of
%, mmHg mmHg
measurement of СО2
SpO2_max – top alarm threshold of SpO2 – from 90 % or from
hemoglobin saturation of arterial blood by oxygen SpO2_min to 100
(hyperoxia) 100 %
SpO2_min – bottom alarm threshold of SpO2 -
60... 95 %
hemoglobin saturation of arterial blood by oxygen 86
(SpO2_max)
Pulse (hypoxia)
oximeter PR_max – top alarm threshold of pulse rate 80 (PR_min)…
90
(taxycardia) 350 1/min
PR_min – bottom alarm threshold of pulse rate 15…100
50
(bradycardia) (PR_max) 1/min
Low pulse volume alarm on/off off
Changing and saving of parameters is carried out by the encoder. Values of alarm thresholds
remain in non-volatile memory and are restored at power up in previous patient mode, except
alarms "FiO2 sensor", "FiO2 alarms", "О2 pressure (min)".
4-45
4.15 Volume settings menu
For the purposes of patient’s safety user can not disable of set alarm
volume less than 30 %.
4-46
4.16 Service menu
• Date/time setting parameter allows to enter the menu of current time and date setting:
• System parameter allows to enter the submenu including the following parameters:
4-47
4.16 Service menu
where:
Work time parameter allows to see the whole operating time of the device.
Time after maintenance parameter allows to control time after the previous maintenance
of the device for the next timely maintenance. For this purpose the expert who was
carrying out maintenance, should choose the “Zero time after maintenance” parameter
and then the time counter returns to starting (zero) position.
Clear alarm log parameter allows to clear information from the memory. For the
activation of this action enter the system password. For exit without emptying the alarm
log press the encoder for 4 times.
Transfer service log parameter allows to make record of maintenance log to the portable
data medium connected to USB-port. The maintenance log is saved in "servicelog.csv"
file, in the csv format with the symbol divider ";", in the CP866 coding.
Technological mode parameter is intended for the transfer of the device to the mode of
the gas leakage test in the breathing circuit being under pressure during inspiratory time,
and also test of pressure drop of the device in the passive exhalation line (the specified
tests are carried out by the manufacturer and in the service centers, for these tests it is
necessary to enter the system password).
Technological child mode parameter is intended for the test of device by the
manufacturer and in the service centers.
Service information parameter is intended for technical staff (to perform the operation it
is necessary to enter the system password).
• Calibration parameter allows to enter submenu including the following parameters:
o CIVL
o CIND
o Breathing circuit calibration
o CAPNO (mainstream capnometer)
o SpO2 module (option).
CIVL parameter is needed for entering to the menu of calibration selection of the
ventilation controller.
4-48
4.16 Service menu
CIND parameter is used to enter the calibration menu of the indication controller:
During the calibration the compliance and resistance of the breathing circuit are defined,
and then used for more accurately calculation of the inspiratory pressure.
CAPNO, CAPNO MS is used to enter the setup and calibration menu of respiratory gas
analysis modules available in the device (mainstream capnometer, metabolism
measurement unit).
If mainstream capnometer and indirect calorimeter are installed (the most common variant
of delivery) the menu looks as follows:
4-49
4.16 Service menu
where:
o Zero calibration for MS capno parameter is used for running of mainstream
capnometer zeroing routine (see it. 5.1);
o Calorimeter O2 sensor calibr. parameter is used for entering to calibration menu of
built-in oxygen sensor for metabolic parameters;
o Capno MS parameter is used for enabling/disabling of mainstream capnometer;
o Technical parameters parameter is used for entering the indirect calorimeter
calibration menu (protected by the password).
SpO2 module parameter is used for entering the control menu of built-in pulse oximeter
parameters (available only if module presents in the device):
where:
o Demo mode parameter enables or disables emulation of the patient;
o PR and SpO2 averaging time parameter allows to change the averaging time of the
displayed parameters (4, 8, 16 s).
• Service menu parameter Alarm autosetting is used for restoring of the alarm threshold
factory settings (see it. 4.14). The maximum pressure limit value Pmax (45 cmH2O) and the
corresponding alarm threshold are also recovered.
• Service menu parameter Factory settings allows, if necessary, reset the ventilation
parameters to their default values (the operation required the system password).
• Service menu parameter Options allows to enable or disable optional functions of the device
(the operation required the system password).
• Service menu parameter "CMS" allows to check the current network settings of the device
and to change them if necessary (protected by password). After making changes restart the
device to apply network settings.
4-50
4.16 Service menu
4-51
4.16 Service menu
After appearing of the message “Calibration successfully completed” the device is ready for op-
eration.
At the failed calibration sensor replacement of device’s repair is required. After sensor replace-
ment conduct calibration in [Menu] → [Service menu] → [Calibration] → [CIVL] → [FiO2 sensor
replacement].
Description of the messages with calibration results see in the Table 4.11.
Table 4.11. Description of the messages with calibration results and FiO2 sensor replacement
4-52
4.16 Service menu
Table 4.12. Description of messages about calibration results of expiratory flow sensor
4-53
4.16 Service menu
4.16.4 Selection of flow correction conditions on the inspiration and the expiration
On the inspiration the device uses the flow sensors, operating on the principle of measuring the
mass of the passed gas. On the expiratory flow sensor measures the volume of the passed
breathing mixture. It is possible to use different types of breathing gas humidification in the
device.
“Insp. conditions” and “Exp. conditions” parameters are intended for selection of conditions for
the conversion of the breathing mixture mass passed through the device to the appropriate
volume. Weight and volume are connected by the equation that contains the partial pressures of
all gas fractions, temperature and the absolute pressure of the mixture.
Select the parameters through the menu: [Menu] → [Service menu] → [Calibration] → [CIVL]
→ [Insp. (Exp.) conditions].
The device provides 4 types of inspiration and expiratory flow correction:
• ATP (Ambient Temperature, Pressure) - the conversion is carried out for the 30 % relative
humidity and ambient temperature of 25 °C.
• ATPS (Ambient Temperature, Pressure, Saturated – 100 % humidity), this correction is
similar to ATP at 100 % relative humidity.
• ATPD (Ambient Temperature, Pressure, Dried – 0 % humidity), this correction is similar to
ATP at 0 % relative humidity.
• BTPS (Body Temperature, Pressure, Saturated – ambient pressure, 100 % relative
humidity).
When working with the bag select ATP correction, when using the humidifier select BTPS.
Incorrect type of correction would lead to the increasing of measurement errors of inspiration
and expiration volume.
4-54
4.16 Service menu
As a result of calibration particularly the compliance of the breathing circuit is measured, that is
then used for its compensation. If the calibration was not carried out the effective compensation
of breathing circuit compliance is impossible. Description of messages with calibration results
see in the Table 4.13.
4 Error: no response from gas Gas mixer malfunction Contact the customer service
mixer
5 Error: wrong data transfer Gas mixer malfunction. Contact the customer service
freq. from gas mixer
6 Error: low ambient air Low ambient temperature or If the ambient temperature is
temperature power unit malfunction. below 15 °C, the move the
device to the warmer place.
Otherwise contact the customer
service.
7 Error: temperature sensor Temperature sensor Contact the customer service.
error in power unit malfunction.
8 Calibration cancelled Calibration is cancelled by Continue operation with the
user. device.
9 High pressure in inspiration Inspiratory line clogging. Clean the inspiratory line and
line repeat the calibration. If the
message appears again contact
the customer service.
4-55
4.16 Service menu
15 Power unit does not respond Power unit does not respond Contact the customer service.
to the requests of ventilation
controller.
4-56
4.17 Alarms
4.17 Alarms
Alarm signals
Alarm system continuously monitors the operating parameters of the device affecting to the
safety of the patient, and indicates the situation where the intervention of the staff is required.
Forms of the alarm signals:
1. Sound alarm. Volume is growing by 10 % every minute in presence of alarm situation;
2. Red indicator “Alarm” on the top side of device enclosure;
3. Message on the screen with the name of the alarm.
Depending on the risk for the patient alarms are classified into three groups:
1. Low priority alarm (green message on the screen);
2. Medium priority alarm (sound alarm, “Alarm” indicator and yellow message on the screen);
3. High priority alarm (sound alarm of the higher frequency and intensity, “Alarm” indicator
and red message on the screen).
Depending on the cause of the occurrence and further consequences, the alarms are divided in-
to 2 groups:
1. Physiological alarms -alarms that occur due to patient condition one or more physiological
parameters monitoring the patient exceed the predefined alarm limit;
2. Technical alarms - alarms that that occur due to the device or alarm system conditions;
If the alarm is triggered check the patient condition to identify and eliminate the cause of the
alarm situation. After removing the cause of the alarm, the device automatically disables the
alarm. If several alarm conditions exist, the device switches to the next alarm situation in order
of their priority.
In the situation of several alarm conditions at the same time alarm with the highest priority is ac-
tivated. Messages about other alarms (up to 6 messages) are displayed in the "Alarm List". The
alarm log stores information about all current and previous alarms. The lists of alarm messages
are stated in Tables 4.15 – 4.17, where the text of the alarm message, the short message in
brackets which is displayed in the "Alarm List" and the alarm log, as well as the response of the
device and operator actions are mentioned. The list of informational messages is stated in Ta-
ble 4.18.
For convenience of the personnel audible alarm can be temporarily disable for 120 s by press-
ing of the button or sound mute icon . The LED above the button informs the personnel
about temporarily disabling of the audible alarm. Disabling of the sound alarms does not result
in disabling of visual alarms.
Before starting the ventilation make sure that alarm system works properly by checking discon-
nection or occlusion alarm. To check the disconnection alarm, assemble the breathing circuit in
accordance with Figure 3.6 and disconnect the breathing bag from the tee of the patient. The
alarm should appear in 30 seconds.
To check the occlusion alarm, assemble the breathing circuit according to the Figure 3.6 and
block the output port of expiration valve (Figure 2.1 position 20). The alarm should appear in 30
seconds.
The ventilator makes self-test after switching on and within the whole operation process. If the
critical failures occurred during initial test the ventilator switches to emergency mode. In this
case normal ventilation does not start and the ventilator’s replacement is required. If the critical
failures occurred during operation the emergency alarm issues but the ventilator continues ven-
tilation process with partial loss of functionality. In case of fatal failure the ventilator could switch
to full emergency mode (FEM) and stop the ventilation. The urgent replacement of ventilator or
application of alternative ventilation method is required. For further information refer to it. 4.17.6.
4-57
4.17 Alarms
Informational messages
Informational messages are intended to inform the operator about events that have occurred in
the device and do not require immediate action from the operator. In the interface the informa-
tional messages are displayed in grey color.
For the user convenience, some informational messages are displayed only in the alarm list in-
dication zone (Figure 4.4position 15) and the message indication zone if there are no active
alarms (Figure 4.4 position 6), some messages are recorded only in the alarm log and events.
The list of informational messages with the indication of the full and abbreviated text of the
message, indication place and comments is presented in Table. 4.17.
Please note that informational messages about the the metabolograph
functioning are displayed only in the status bar of the metabolograph and
are not displayed either in the "Alarm List" or in the alarm log. The list of
metabolism status messages is presented in Table. 5.1 section 5.5
Metabolograph.
4-58
4.17 Alarms
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
Physiological alarms
1 Disconnection Disconnection Check the tightness of the breathing circuit
(Disconnection) Pressure drop in the patient’s connections. Check the tightness of the
breathing circuit breathing circuit and expiration valve of the
device. Check humidifier.
If necessary replace the breathing circuit.
Alarm is disabled at the restoring pressure in
the first normal breathing cycle.
2 Apnea Press Apnea This alarm may occur in the SIMV,
encoder No spontaneous breathing of CPAP+PS and BiSTEP, NIV modes. Check
(Apnea) the patient at the period of the the patient. Turn on the mandatory mode or
set apnea time Tapnea increase the frequency of mandatory breaths
in SIMV modes. The alarm is automatically
disabled when the patient makes two se-
quential unassisted breathing cycles.
3 Occlusion Occlusion Check for breathing circuit occlusion or
(Occlusion) Achieving of maximum permiss- clamping. Check inspiration/expiration filters
ible inspiratory pressure at the for contamination, if necessary clean.
volume of inspiration less than Alarm is disabled after 2 consecutive normal
50 % breathing cycles.
4 Low Vexp Low Vexp Check the patient for adequate ventilation
(Low Vexp) Expiratory volume is below the and circuit for hermiticity. If necessary adjust
set bottom threshold the bottom alarm threshold. Alarm is dis-
abled when expiratory volume exceeds the
bottom alarm threshold.
5 High Vexp High Vexp Check the patient for adequate ventilation
(High Vexp) Expiratory volume is above the and circuit for hermiticity. If necessary adjust
set top threshold. Without lea- the top alarm threshold. Alarm is disabled
kage this alarm is equal to high when expiratory volume is below the top
inspiration volume alarm alarm threshold.
6 High minute vo- High minute volume Check the condition of the patient in for the
lume Minute expiratory volume is hyperventilation. If necessary reinstall the
(High MV) above the set top threshold. alarm limit of high minute volume.
Increase inspiratory trigger threshold if there
is suspicion of auto triggering. Alarm is dis-
abled when minute volume is below the thre-
shold.
7 Low minute vo- Low minute volume Check the patient for adequate ventilation
lume Minute expiratory volume is be- and circuit for hermiticity. If necessary in-
(Low MV) low the set bottom threshold. crease the frequency, tidal volume, support
pressure or trigger sensitivity.
8 Pmax is reached Pmax is reached Check the patient. Check breathing cir-cuit
(Рmax reached) Pmax set by user is achieved. and flow sensor tubes for the in-flection and
occlusion. Alarm disappears at the first nor-
mal breathing cycle with the real value of PIP
below Pmax specified by the user.
4-59
4.17 Alarms
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
9 High EtCO2 High EtСО2 Check the patient for adequate ventilation
(High EtСО2) The measured value of the CO2 and circuit for hermiticity. If necessary adjust
concentration is above the set the top alarm limit. Alarm is disabled at de-
top threshold. creasing of the exhalation volume below the
top threshold alarm.
10 Low EtCO2 Low EtСО2 Check the patient for adequate ventilation
(Low EtСО2) The measured value of the CO2 and circuit for hermiticity. If necessary adjust
concentration is below the set the bottom alarm limit. Alarm is disabled
bottom threshold. when expiratory volume exceeds the bottom
threshold alarm.
11 Low inspiration Low inspiration pressure Check the patient for adequate ventilation
pressure The measured maximum inspi- and circuit for hermiticity. If necessary adjust
(Low pressure) ratory pressure is less than the the alarm limit. Alarm is disabled at the first
set threshold. breath with the pressure above the set thre-
shold.
12 Target MV is un- Target MV cannot be achieved. Special alarms of iSV mode, see the descrip-
reachable tion in it. 4.17.5. Check the patient condition.
(Trg.MV un- Check the alarm limits, adjust them if neces-
reach) sary.
13 Vtmin reached Tidal volume Vt reached mi- Special alarms of iSV mode, see the descrip-
(Vtmin reached) nimal level Vtmin. tion in it. 4.17.5. Check the patient condition.
Check the alarm limits, adjust them if neces-
sary.
Technical alarms
14 TRANSITION TO The critical malfunction in the Use alternative ventilator. Remove the de-
FEM device occurred. The device vice from operation, see it. 4.17.6.
(TRANSITION operation is failed. Contact service department.
TO FEM)
15 Tech. Failure The technical malfunction oc- Further operation of the device is not possi-
(Tech. Failure) curred during switching on. . ble, see it. 4.17.6. Contact service depart-
The device operation is failed. ment.
16 Technical mal- The technical malfunction oc- Ventilation continues with the partial loss of
function x curred in a one unit of the de- functionality. Replace the device. Contact
(from 1 to 7) vice. service department.
(Tech. malf. x) A detailed description of the malfunction and
an indication of the unit in which the malfunc-
tion occurred are given in Table App.5.1,
Appendix 5.1.
17 Technical mal- The technical malfunction oc- Ventilation continues with the partial loss of
function CIND curred in CIND. functionality. Replace the device. Contact
(Tech. malf. service department.
CIND)
18 Technical mal- The technical malfunction oc- Ventilation continues with the partial loss of
function CIVL curred in CEIVL. functionality. Replace the device. Contact
(Tech. malf. service department.
CIVL)
19 Technical mal- The technical malfunction oc- Ventilation continues with the partial loss of
function Gas Mix. curred in GM. functionality. Replace the device. Contact
(Tech. malf. GM) service department.
4-60
4.17 Alarms
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
20 Accumulator is The accumulator is fully dis- Connect the device to the mains power to
discharged charged. Accumulator’s charge charge the accumulator. The alarm message
(Acc Discharged) is insufficient to continue the will be removed after beginning of the charg-
normal operation of the device ing. Contact service department in case of
failure.
21 Less than 10 mi- The accumulator is fully dis- Alarm disappears in the accumulator charg-
nutes left charged. Accumulator’s charge ing mode (mains power).
(< 10 min left) is insufficient to continue the Immediately connect the device to the mains
normal operation of the device. power to charge the accumulator. The alarm
Prior to the full discharge is less message will be removed after beginning of
than 10 minutes. the charging. Contact service department in
case of failure.
22 Accumulator The accumulator malfunction When the device is switched on, the operator
malfunction occurred. will be offered to switch to the technical fail-
(Acc. malfunct.) ure mode or continue operation with the risk
of a sudden shutdown, see it. 3.4.
23 Low O2 concen- The measured value of the Check the connection and the supply of oxy-
tration oxygen concentration FiO2 is gen to the device. If necessary change the
(Low О2 ) below set by the operator dev- limit of O2 tolerance. Alarm automatically
iation (1 - 50 %). disappears when the oxygen concentration
is returned to the normal range.
24 High O2 concen- The measured value of the Alarm disappears when the oxygen concen-
tration oxygen concentration exceeds tration returns to the normal range.
(High О2 ) the set value on the specified
value.
25 Fan malfunction The electronic unit fan malfunc- Contact service department. The device may
(Fan malfunct.) tion occurred. shortly continue normal operation. Alarm dis-
appears after restoring of the normal opera-
tion of the fan.
26 Sound malfunc- Faulty dynamic transducer Further operation of the device is impossible.
tion (breakage). Contact service department.
(Sound malfunc.)
27 FiO2 sensor mul- The ventilation controller The function of FiО2 level monitoring is not
fanction FiO2 sensor malfunction oc- available. There is no change in FiО2 level
(FiO2 s. malf.) curred. control. The device can operate for a short
period of time. Contact service department.
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
Physiological alarms
1 High RB Controlled respiratory rate is The alarm is automatically disabled when the
(High RB) above than the specified top respiratory rate is equal or less than alarm
threshold. threshold.
If necessary, reduce the respiration rate, or
adjust the alarm threshold. If autotriggering
is suspected, increase the trigger threshold
of the inspiratory trigger.
4-61
4.17 Alarms
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
2 Low RB Controlled respiratory rate is The alarm is automatically disabled when the
(Low RB) below the specified bottom respiratory rate is equal or higher than alarm
threshold. threshold.
3 Low PEEP PEEP value is below the speci- Check the ventilation adequate and tightness
(Low PEEP) fied bottom threshold. of patient circuit. If necessary adjust the
alarm limit. Alarm is disabled at the first
breath with the pressure above the set thre-
shold
4 High SpO2 Measured SpO2 value is above The alarm is disabled when the SpO2 value
(High SPO2) the specified top alarm thre- returns to the permissible range.
shold.
5 Low SpO2 Measured SpO2 value is below The alarm is disabled when the SpO2 value
(Low SpO2) the specified bottom alarm returns to the allowable range.
threshold.
6 High PR Measured pulse rate is above The alarm is disabled when the measured
(High PR) the specified top alarm thre- frequency value returns to the allowable
shold. range.
7 Low PR Measured pulse rate is below The alarm is disabled when the measured
(Low PR) the specified bottom alarm frequency value returns to the allowable
threshold. range.
8 SpO2 sensor The pulse oximetry sensor is Connect the sensor to the patient.
taken off disconnected from the patient.
(SpO2sens.t-off)
9 Low pulse signal The relative level of blood pul- Provide the required level of perfusion at the
(Low pulse) sation at measuring point is 0.3 location of the SpO2 sensor application.
% or less Change the location of the SpO2 sensor ap-
plication.
The alarm is disabled when the pulse filling
value becomes higher than 0.3%.
Technical alarms
10 Calibrate FiO2 Oxygen sensor calibration is The alarm is disabled after the FiO2 sensor
sensor (Cal.FiO2 required calibration [Menu] [Service menu] [Calibra-
sens.) tion] [CIVL] [FiO2 sensor calibration];
11 High O2 pressure Input pressure in the oxygen Contact service department. It is necessary
(High O2 press.) line exceeds 2.5 bar to replace the filter regulator.
12 Low O2 pressure Input pressure in oxygen line is The alarm is disabled, when normal pressure
(Low O2 press.) below the set bottom threshold is restored.
13 No mains voltage No mains voltage. The device If there is a risk of power supply failure for a
(No mains) automatically switched to bat- considerable time, ensure of the back-up
tery operation. methods of mechanical ventilation, which will
be necessary when the battery discharge.
The alarm is disabled, when connected to
the power supply.
14 Maintenance The maintenance counter mal- The device can operate for a short period of
counter error function occurred. Maintenance time. Contact service department.
(Maint.count er) counter keeps a count of time
passed from last maintenance.
4-62
4.17 Alarms
Reaction of ventilator,
No Alarm message Alarm conditions
operator’s actions
15 Touch screen is Detection of long pressing on Operating with the touch screen is locked.
jammed (TS the touch screen The alarm is disabled, when you stop press-
jammed) ing the touch screen. If it occurs for no ap-
parent reason, contact service department.
Ventilation continues without the possibility
of changing the ventilation parameters.
16 Check capno Adapter of the mainstream The alarm is disabled after cleaning the
adapt. and calibr. capnograph is contaminated adapter and performing calibration, see it.
(Check CO2 5.1.
adap)
17 SpO2 sensor er- The pulse oximetry sensor er- Replace the pulse oximetry sensor. Contact
ror (SpO2 sens. ror service department in case of failure.
err)
18 Nebulizer failure The nebulizer control unit mal- Further operation of the device is possible
(Nebul. failure) function occurred. without the nebulizer. The further operation
of the nebulizer is not possible. Contact ser-
vice department.
19 Paux sensor fail- The external pressure sensor Further operation of the device is possible
ure (Paux malfunction occurred. without external pressure monitoring Paux.
sens.fail) Contact service department.
4 Calibr. error (Ca- Calibration error during calibra- Calibration is not performed. Repeat the ca-
libr. error) tion process. libration, following the instructions on the
screen of the device; see also the relevant
it. 4.16.2 - 4.16.5.
5 Protocol Conver- The protocol converter module Further operation of the device is possible
ter error malfunction occurred. without the mainstream capnometer. Con-
(Prot.Conv. err) tact service department.
4-63
4.17 Alarms
10 SpO2 module not The pulse oximetry module is The module is missing. Contact service de-
initialized (SpO2 not initialized during the device partment.
not init) switching on
11 Capnometer not The capnometer is not initia- The module is missing Contact service de-
initialized (Cap- lized during the device switch- partment.
no not init) ing on.
12 Calorimeter not The metabolism measurement The module is missing. Contact service de-
initialized (Ca- module is not initialized during partment.
lor.not init) the device switching on.
13 CAN-Eth not in- The CAN-Eth is not initialized The module is missing Contact service de-
itialized(CAN- during the device switching on. partment.
Eth no ini)
14 No Calorimeter No connection with metabolism The module is missing Contact service de-
module measurement module. partment.
(No Calorimeter)
15 Trends failure The trends access malfunction The memory card error occurred. It is not
(Trends failure) occurred. possible to view and save trends, does not
affect on the device operation. Contact ser-
vice department.
16 USB: data media The USB data storage is full Replace the USB Mass Storage with a new
is full (USB: no one with enough free space.
space)
17 Update Pa- The PvCO2 and / or PaCO2 val- Check the patient condition. Update the
CO2/PvCO2 ues were not updated for more PvCO2 and / or PaCO2 values.
(Update CO da- than 4 hours or the EtCO2 value
ta) changed for more than 30%
from EtCO2 measured during
the calculation of cardiac output
4-64
4.17 Alarms
4-65
4.17 Alarms
4-66
4.17 Alarms
es cannot be used longer than their specified time, because this may cause harm to the patient
or even fatal consequences.
In FEM safety valve is opened, expiration valve is opened, only spontaneous breathing of the
patient through the device is possible. At the emergency mode continuous alarm signal sounds,
following information appears on the screen:
• A message about the switching to FEM and necessity to replace the device;
• Time and date of switching to FEM;
• Table of the major units of the device with indication of the software versions and error codes
intended for technical diagnostics of ventilator’s malfunction (see interpretation of error codes
in the Appendix 5).
When you turn the ventilator turned off in FEM the ventilator switches to technical failure mode.
It is not possible to use the ventilator in FEM, please contact the customer service in that case.
Technical failure mode
The technical failure mode is switched on automatically in case of ventilator’s module
malfunction during the turning on. The ventilator switches to technical failure mode when you
turn it on again in FEM or turn it on for the first time when it was switched to FEM in off mode
(e.g. due to improper storing conditions).
There is no ventilation in technical failure mode. At the technical failure mode continuous alarm
signal sounds, following information appears on the screen:
• A message about the switching to technical failure mode and necessity to replace the device;
• Time and date of switching to technical failure mode;
• Table of the major units of the device with indication of the software versions and error codes
intended for technical diagnostics of ventilator’s malfunction (see interpretation of error codes
in the Appendix 5).
4-67
4.17 Alarms
It is not possible to use the ventilator in technical failure mode, please contact the customer
service in that case.
4-68
4.18 Extended respiratory monitoring
When selecting "RESP 1" or "Monitoring" rows, device will return to the main monitoring screen.
When selecting "RESP 2" or "RESP 3" windows with their own set of monitoring parameters are
displayed. "Metabolism" window displays parameters of metabolism (see it. 5.6).
4-69
4.18 Extended respiratory monitoring
If the parameter is not measured, dashes are displayed instead of its value. Also dashes appear
before the first measurement of parameter. If the parameter is measured, but the last mea-
surement was incorrect, flashed dashes are displayed.
By clicking on the icon in the top part of the window, user returns to the "RESP 1" window.
4-70
4.19 Features of using virus-bacterial and heat and moisture exchange filters
Figure 4.12 – The effect of extending of the expiraiton flow due to the increased filter resistance
The heat and moisture exchange filter in the breathing circuit can significantly increase resis-
tance to the inspiration and expiration.
Increased resistance causes the increased patient’s work during spontaneous breathing or in-
itialization trigger effort at trigger support ventilation. Under unfavorable circumstances, increas-
ing of the expiration resistance can lead to an undesirable increasing of the pressure in the res-
piratory system of the patient (autoPEEP phenomenon).
The resistance connected with the heat and moisture exchange filter, the device cannot control
directly. Therefore, when using the heat and moisture exchange filter user should:
• frequently monitor the patient's condition;
• carefully follow to the guidance on the proper use of heat and moisture exchange filter.
4-71
4.20 Nebulizer
4.20 Nebulizer
The device provides the use of pneumo spray-type nebulizers (inhalation solutions sprayers),
for example, CIRRUS 2505 made by INTERSURGICAL. These nebulizers are intended for op-
eration with one patient and cannot be sterilized and reused.
While working with the nebulizer, do not use heat and moisture exchange fil-
ter. Inhalation of different medicines can cause blockage of the filter with in-
creasing resistance to exhalation of the breathing circuit.
For preparing the nebulizer for operation:
• Connect the connecting tube supplied with the nebulizer to the "Nebulizer" fitting on the
front panel of ventilator and to the inlet fitting of the nebulizer (see Figure 4.13).
Figure 4.13 – Connection of the connecting tube of the nebulizer to the nipple on the front panel
of the ventilator
• Connect the nebulizer to the breathing circuit as shown in Figure 4.14. Operating position of
the nebulizer is below the breathing circuit.
• Make sure that device is working properly in the appropriate ventilation mode.
• Set the desired time of nebulizer’s operation in [Menu] → [Additional functions] → [Nebul.
work time] (0 - 60 min).
• Turn on the nebulizer by pressing the encoder.
It is possible to turn the nebulizer on only if the device operates in one of the ventilation modes.
If you turn the nebulizer immediately at the power supply, nothing will happen.
During inhalation in the indication area gray information message "Nebulizer is on" is displayed.
After the set time interval inhalation stops automatically, and the message disappear.
For early termination of the inhalation select "Nebul. work time 0 min" in [Menu] → [Additional
functions].
When user turns the nebulizer on again, countdown will start working.
The device can be provided with blocking of nebulizer in pediatric mode. In addition operation of
the nebulizer is blocked in ventilation mode with the volume control with set VT of less than 100
ml.
For the operation in the pediatric mode, the nebulizer with vibrating mesh without introducing
additional flow is recommended (AeroNeb PRO), which can be supplied on request in the deli-
very kit of the device. Such nebulizer does not require synchronization with the device and op-
erates independently. All controls are located on the nebulizer.
During the operation in every breathing cycle the device delivers pressure of 1.8 bar into the
spray chamber of nebulizer. Pure oxygen is used to create the pressure.
At every inspiration medicines are sprayed from the inhaler container. Since spraying is carried
out with oxygen, FiO2 value of the inspired gas mixture slightly increases. Therefore during inha-
lation, it is necessary to consider an increase in oxygen concentration in air mixture.
Due to its principle of operation the nebulizer creates additional inspiratory flow. In the modes
with volume control the device software takes into account this additional flow.
The software of the ventilator blocks the nebulizer if set tidal volume is less than the additional
flow generated by the nebulizer. In this case it is necessary to transfer the ventilator to operation
with the pressure control.
In the absence of pressure in oxygen line and if the nebulizer is turned on, the display will show
that the nebulizer is on, however, compressed oxygen will not enter the chamber because of its
absence. So spraying of the medicines by the nebulizer will not occur.
4-73
4.20 Nebulizer
4-74
4.21 "Open valve" function
Paw
F(t)
3
3
1
2 4
4
1 – hardware inspiration
2 – hardware expiration
3 – spontaneous inspiration
4 – spontaneous expiration
Figure 4.16 – Spontaneous inspirations and expiration at any phase of ventilator’s breathing
cycle
“Open valve” function increases flow of the inspired mixture in the presence of spontaneous pa-
tient’s effort, allowing him to breathe (3) regardless of the hardware respiratory cycle phase (1,
2) and opens the expiration valve at the patient’s attempt of exhalation (4) independently the
phase of the hardware respiratory cycle (1, 2). The device will maintain the pressure corres-
ponding to the phase of the ventilator’s breathing cycle.
Note:
The sensitivity threshold of the function is 0.2 mbar
4-75
4.21 "Open valve" function
4-76
5.1 Mainstream CO2 sensor (capnometer)
The module includes the mainstream CO2 sensor and ventilation adapters for different types of
patients:
5-1
5.1 Mainstream CO2 sensor (capnometer)
Figure 5.3 – Connecting the CO2 sensor to the CO2 connector of the ventilator
• Make zero calibration of capnometer if necessary (the first use of the module, or change of
the ventilation adapter type).
• Insert the ventilation adapter between the elbow and tee of the ventilator circuit according to
the scheme on Figure 5.4.
5-2
5.1 Mainstream CO2 sensor (capnometer)
Do not use CO2 measurement results as the only basis for measuring venti-
lation parameters without taking into account clinical data and independent
indicators, such as blood gases. CO2 measurements may be inaccurate if
there is a leak in the circuit or the sensor is fault.
Place the CO2 sensor and cable in a such way to avoid entanglement, suffo-
cation, or accidental rupture of the cable
During the calibration procedure, the airway adapter shall be installed in the
mainstream CO2 sensor and disconnected from the breathing circuit.
When the ventilation adapter is changed with the adapter of the same type, generally calibration
is not required.
To calibrate:
• Wait for completion of warm-up interval of the capnometer (message of the warming up on
the display will disappear).
• Enter [Menu] → [Service menu] → [Calibration] → [CAPNO].
5-3
5.1 Mainstream CO2 sensor (capnometer)
5-4
5.2 Volume capnometry
t1 t2 t3
Flow, Fpat(t)
Capnogram, CO2(t)
5-5
5.2 Volume capnometry
Method of calculation of the functional dead space that effectively allows to assess the volume
of gas lost in the respiratory tract, or gas that doesn’t take part in the gas exchange is modified
Bohr equation:
t3
1
t 3 − t 2 t∫2
EtCO 2 i − CO 2 (t ) ⋅ dt
Vd i = ⋅ Vt i (3)
EtCO 2 i
Minute ventilation contains not only gas that participates in the gas exchange, but ventilation is
wasted in the airways. Thus the high minute ventilation does not always indicate the actual
achievement of the alveolar area. Some part of the tidal volume falls into non-perfused or poorly
perfused lung areas. MValv/Vd ratio characterizes the ratio of alveolar ventilation and dead
space ventilation, and allows to evaluate the severity of disease.
To display the volume capnometry parameters select “EtCO2/VCO2” and “MValv/Vd” in the
menu of settings of measuring parameter blocks (it.4.12.2) or by pressing of the touch button on
the corresponding measurement parameter field:
The device also displays the graph of the instantaneous amount of carbon dioxide CO2 exhaled
by the patient
5-6
Cardiac output by Fick
Enter the menu of venous and arterial CO2 concentration parameters by pressing on the digital
values of "CO/VCO2", which is touch button, or through the menu of additional functions:
In this menu enter the value of the venous (PvCO2) and/or arterial (PaCO2) CO2 concentration
obtained using one of the laboratory techniques. There are three possible ways to enter para-
meters:
1. Enter only PvCO2 value, PaCO2 value is calculated automatically as PvCO2–5 mmHg.
2. Enter only PaCO2 value, PvCO2 value is calculated automatically as PаCO2+5 mmHg.
3. Enter both values PvCO2 and PаCO2.
5-7
Cardiac output by Fick
Explanatory inscriptions "entered by the user" and "calculated" show the way of entering of pa-
rameter.
At the entering of venous concentration parameters PvCO2 and PаCO2 they are checked for cor-
rectness:
• permitted range 10 - 150 mm Hg,
• venous CO2 concentration is always higher than arterial,
• delta of blood from 3 to 12 mmHg; if the values are outside the allowable limits, boundary
values are taken.
If PaCO2 and/or PvCO2 values were not updated for more than 4 hours or EtCO2 value changed
for more than 30% since last CO measurement, the ventilator displays the warning message:
"Update PaCO2/PvCO2".
5-8
5.4 Pulse oximetry module
To avoid damage of the sensor never try to pull on the cable to unlock the
connector!
5-9
5.4 Pulse oximetry module
• At impossibility of proper placement of the sensor on the selected finger choose another fin-
ger.
• The universal pulse oximetry sensor can be applied for all patient groups.
• If you use the universal pulse oximetry sensor on neonates or infant, apply the sensor
on palm or foot (Fig. 5.9). There is no difference from which side an emitter located. Fix
the sensor by strap.
• If you use the universal pulse oximetry sensor on child or adult, apply the sensor on
finger and fix it by the strap, as shown on Fig. 5.10.
5-10
5.4 Pulse oximetry module
SpO2 monitroring:
• Select the SpO2 graph in the [Menu] → [Display settings] → [Graphs]:
• After installing of the sensor to the patient over some time (period of adaptation) photople-
thysmogram appears on the screen. It is visual indication of the pulse (figure. 5.11, item 5).
To the left from it is a column showing the pulse volume level (item 2). In saturation window
measured numeric value of SpO2 is displayed (item 3). If four graphics on the screen are set,
the only PPG curve will be shown.
3 4 5 6 7
• By clicking on the SpO2 graph field with numeric values (which are graphical buttons) menu
of thresholds settings becomes available:
In this menu user can set the required SpO2 and PR alarm thresholds and disable the low pulse
volume alarm.
Because automatic control of the alarm signal triggering in the device is
not provided, it is necessary to check the activation of the alarm by chang-
ing the value of the upper or lower threshold of one of the parameters.
• By clicking on other areas of SpO2 graph without numerical values control menu of the SpO2
module becomes available:
5-11
5.4 Pulse oximetry module
The "PR and SpO2 averaging time" parameter is set depending on the patient's mobility and re-
gulates the averaging time of the displayed SpO2 and PR (standard default value is 16 s, that is
most suitable for restless patients).
The device does not allow to adjust the delay of alarm signal triggering, but allows to adjust av-
eraging time that influences to the delay.
At the minimum averaging time (4 s), the alarm signal triggering will occur earlier with respect to
the parameter change and its crossing the alarm thresholds than at the maximum averaging
time (16 s).
• Pulse volume is the numerical value of the pulsating component of the measured signal
caused by the pulsation of arterial blood flow. As pulse oximetry is based on the ripple signal,
the pulse volume parameter can be used as the quality indicator for the SpO2 measurement.
The entire scope of the volume pulse bar corresponds to 10 %. If the pulse volume is 0.3 %
or lower, the bar will turn red, the frame surrounding the bar will blink red, and the display will
show the message "Low pulse signal".
• Small signal amplitudes are automatically enhanced, so photoplethysmogram always has
approximately the same size, so follow the physiological view of the curve (non-physiological
curves can be recognized by the angular or the toothed form or by the increased noise).
To eliminate the violations of local circulation till the press necrosis and to
obtain reliable measurement results reinstall the pulse oximetry sensor at
least every 4 hours (for children up to one year - every 30 ... 60 minutes).
The sensor wetted by the liquid or with damaged insulation can cause
burns during the use of electrosurgical instruments. Use only dry and fault-
less sensors.
Sensor wire should never lie under the patient to avoid bedsores.
Avoid the falling of the sensor or its cable under the wheels of carts and
other heavy objects to prevent them from damage and failure.
Only pulse oximetry sensors listed in the "Delivery set" section of the cur-
rent Manual can be used with the device. The wavelength of the sensor’s
emitters in the radiation maximum in the red range is 660 nm, in the infrared
range of 905 nm.
The SpO2 measurement accuracy
• SpО2 Measuring accuracy in a range 70 - 100 %: ±2 %
• Data update period: 1 s
The SpO2 measurement accuracy comply with international standard ISO 80601-2-61. Com-
pliance tests were made by using pulse oximetry sensor, reusable, clip, adult RM.501.00.124-
01 and pulse oximetry sensor, reusable, wrap, neonatal RM.501.00.004-01. The measurement
5-12
5.4 Pulse oximetry module
accuracy was defined as a result of clinical tests on 64 patients from ICU (adult at the age from
20 to 81 years and neonates/infants at the age 10 days to 7 month, male and female, white skin
color) using CO-oximeter.
The SpO2 measurement accuracy in the condition of low perfusion (from 0.04 to 0.4) was con-
firmed by the tests performed on simulator Biotek Index 2 for pulse volume higher that 0.04%.
The measurements carried out by the pulse oximetry module are proba-
bilistic and it can be expected that only two thirds of these measure-
ments can fall within the limits of the standard deviation in comparison
with the measurements performed with the CO-oximeter.
5-13
5.5 Metabolism measurement module
• Join the airway adapter with mainstream capnometer and connect it to the patient's tee in the
breathing circuit.
• Connect the monitoring line adapter to the airway adapter of the mainstream capnometer.
• Connect the monitoring line to the adapter on the breathing circuit and to the water trap on
the ventilator*.
* - use the monitoring line from the delivery set or similar (internal diameter 1.2 mm, length 1.8 ... 2 m
with two connectors of the Luer-Lock type at the end).
During preparing for the operation observe the following guidelines:
Make sure that all elements of measurement scheme are securely con-
nected to each other. The measurement results are not valid If the lea-
kage occurred.
• Use only clean and dry sampling lines, without drops of liquid inside.
• For dripping of the condensate produced in connecting device middle part of it should be
hung higher that its ends. Port of the adapter connected to the sampling line should be faced
up to eliminate the accumulation of moisture in the adapter (see Figure 5.13).
• Check the appearance of the metabolic parameters display window and the status message
"Measurement" in the bottom line of the window:
5-15
5.5 Metabolism measurement module
Metabolism status messages are displayed only in the bottom line of the
“Metabolism” window. These messages are not displayed neither in the
area of alarm list indication nor ‘Alarm log’ section.
5-16
5.5 Metabolism measurement module
14. Not used Metabolism module is not Metabolism module is not used. The mes-
used sage disappeared automatically after start-
ing operation.
15. Blowing failed Blowing failed The message disappeared automatically af-
ter finishing of the blowing.
Handle the contents of water trap as you would handle any bodily fluid.
Failure to follow this instruction causes infection.
• During long-term operation of metabolism measurement module under high humidity of the
sample gas sampling line can accumulate a significant amount of condensate, which leads to
the formation of liquid droplets. Large number of droplets can cause occlusion of the measur-
ing path and metabolism measurement module malfunction. In the case of frequent messag-
es about tract occlusion it is usually sufficient to replace the sampling line for a new dry one.
• After every finishing of operation with metabolism measurement module it is recommended
to disconnect the sampling line from it and run for 5 ... 10 minutes to dry its internal pneumat-
ic system, and to extend the service life of the oxygen sensor.
5-17
5.5 Metabolism measurement module
Timely empty the water trap, never allow its limit filling. Remember that the
liquid in the measuring path of metabolism measurement module may
cause undesired operation! In case of ingress of liquid in the measuring
path of metabolism measurement module WARRANTY REPAIR IS NOT
PERFORMED.
5-18
5.6 Compensation of endotracheal tube resistance
Selection of the tube diameter is made depending on the patient's ideal weight IBW in the per-
mitted range of the weight (for the protection from errors):
The average value of the ET diameter for the current ideal body weight of the patient is set by
default.
The function of the endotracheal tube compensation is available in CPAP+PS mode by adjust-
ing of ETC parameter in the line of ventilation parameters setting (top row).
The user can select the desired level of the tube resistance compensation from 0 to 100 %. A
value of 0 corresponds to the OFF state (the initial state of the device at power up).
Optionally the function of the endotracheal tube compensation may be available in other modes
of the ventilation.
At the activation of the tube resistance compensation, the instantaneous pressure after the tube
is calculated as follows:
Paw1 = Paw - ∆P (9)
where: Paw1 – pressure after (below) the tube, cmH2O,
Paw – measured pressure, cmH2O,
∆P – pressure drop on the tube calculated according to the data about the type and diameter
of the tube and the set degree of compensation, cmH2O
Also at the activation of the function pressure curve changes its form on the device’s display.
Not only the pressure in the circuit, but also calculated pressure below the tube is displayed
5-19
5.7 “Auxiliary external pressure” function
Paw
Paw1
Monitoring of external auxiliary pressure waveform is made on any graph field by selecting of
the Paux curve for displaying in [Menu] → [Display settings] → [Graphs].
On Paux curve following data are displayed:
• Paux scale (coincides with the Paw graph, is set by the parameter Pmax);
• external pressure curve on a blue screen;
• yellow Paw-Paux curve:
5-20
5.7 “Auxiliary external pressure” function
At selection of the "Loop" type of graphs the spirometric loop V/Paux becomes available:
• Connect a respiratory (virus-bacterial) filter with the Luer connector and an monitoring line to
the Paux pressure port.
5-21
5.7 “Auxiliary external pressure” function
• Insert the adapter of the catheter into the flex tube with connector:
• Pass the catheter from the delivery set of the device through the adapter of the catheter into
the flex tube connector. Cut the catheter tube according to the length of the endotracheal
tube (Figure 5.20a). Connect the monitoring line to the catheter (Figure 5.20b).
а) b)
Figure 5.20 – Connecting of the catheter (а) and monitoring line (b)
• Connect the endotracheal or tracheostomy tube to the flex tube connector (Figure 5.21a).
Then the assembly should be connected to the tee of the breathing circuit (Figure 5-21b).
5-22
5.7 “Auxiliary external pressure” function
a) b)
Figure 5.21 – Connection of the endotracheal tube (a) and the tee of the breathing circuit (b)
Figure 5.22 - Connection of the esophageal balloon catheter or multifunction nasogastric cathe-
ter to the ventilator
5-23
5.8 Operating with low pressure oxygen source
• By the flow regulator on the low-pressure oxygen source set the oxygen flow approximately
corresponding to the minute respiration volume. If the minute volume is greater than the ca-
pacity of the oxygen concentrator, set the maximum flow value. It is allowed to set the maxi-
mum flow value on the oxygen concentrator even at the required minute respiration volume <
5 lpm. In this case there will be only a certain oxygen overcharge, and the device will provide
the set oxygen concentration.
• Disable the low oxygen pressure alarm in the device's menu, see it. 4.14
• Disable the FiO2 deviation alarm, see it. 4.14.
When operating with a low-pressure oxygen source, it is necessary to take into account certain
features of the ventilator design:
• The mixer of device tries to create the desired flow of oxygen at any inlet pressure. If the
oxygen flow is less than required, oxygen deficit is replaced by air and the measured FiO2
value will be differ from the set value.
• When using oxygen concentrator, in the moment of maximum inspiratory flow oxygen pres-
sure can vary greatly, but there are no significant changes in FiO2 due to the oxygen line ca-
pacity.
Table 5.2. Approximate limits of maintaining of the oxygen concentration in the inspired gas dur-
ing operation from the oxygen concentrator with performance of 5 lpm
Minute volume of breathing Peak inspiratory flow, Achievable FiO2, with error
(MV), lpm lpm, maximum value < 10%
5 15 55
10 30 45
15 45 37
5-24
5.9 Data exchange with computer
The functions of the oxygenation and nebulizer are not available during
operation from the low pressure oxygen source.
Window screenshot
The device can be equipped with the function of saving the current screen image (screenshot)
to the external device USB-flash memory.
Before working with the device connect the standard device USB-flash memory to the USB-
connector on the rear panel.
To save the image on the screen of the device, press the button on the main screen of de-
vice (figure 4.4, position 8).
Image is saved in the file scr0000.bmp (number changes with the increasing of the number of
files) in the SCREEN directory (file system FAT).
During screenshot (up to 40 sec), the work with the interface (touch
screen, buttons and encoder) is blocked; the content of the screen is not
updated. This condition is indicated by symbol . Ventilation is not in-
terrupted, and the rest of the algorithms of the device are normally carried
out.
3 step: data format - in “more detail” select split the integer and fractional part "." (point).
After setting all the parameters, select "Done" and in the new window select the import of data
into a new sheet, then click OK.
In the upper line contains the parameter names, the leftmost columns have the time of the
trend recording in the format day / month / year / hour / minute. The line records the parameter
values for the current moment. The bottom line shows the serial number of the ventilator.
To avoid malfunctions, before turning on the device connect standard USB flash memory de-
vice (USB-flash) to the USB connector on the rear panel.
To record a trend fragment, enter the trend view function, select the necessary fragment (i.e.,
the beginning and end of the trend). The record scale of a trend fragment can be changed via
[Menu] - [Trends] - [Edit] on 156; 312 or 104 minutes. If USB flash drive is inserted into the
slot, the RECORD button will be available in the lower right corner of the trend screen. Active
button is bright yellow, non-active is gray. At clicking button the selected trend fragment is
saved to a file. The file name is trend0000.csv (the number is changed when the number of
files is increased)
5-26
6.1 Maintenance schedule
To ensure the proper functioning of the device during its service life make regular maintenance
in accordance with it. 6.1
Maintenance of device is the responsibility of the user of the device and is not included in the
warranty obligations of the manufacturer or supplier.
Maintenance routines do not involve disassembly / assembly of the electronic unit and does not
require specialized skills and knowledge.
If any defects that require disassembly of the electronic unit are found, the device must be
transferred to the repair organizations authorized by Triton Electronic Systems Ltd. that have
the proper qualifications and the necessary equipment.
Maintenance should be carried out with the frequency recommended in it.6.1. Even if the device
is taken out of service and is temporarily stored, at least every 6 months check the operation of
the device and the FiO2 sensor, perform the training of the built-in rechargeable battery.
* - Calibration of mainstream CO2 sensor is performed with every replacement of the airway adapter or
breathing circuit
** - Calibration of the breathing circuit is intended to adapt the device to the breathing circuit. It is recom-
mended to perform it at the device turning on and especially at changing of breathing circuit type.
6-1
6.2 Visual inspection and test of controls
6-2
6.5 Check of the filter-regulator
Check the O-ring of the water trap reservoir of the reducer. The ring should not have visible
damage or undue strain.
Check the O-ring in the cap nut of the filter-regulator for connection to the O2 port. The ring
should not have visible damage or undue strain. If necessary replace with supplied spare one.
Check the microfilter, in the case of severe contamination replace by supplied spare filter. For
this purpose unscrew the filter housing and then the filter itself from the housing (Figure 6.2). In-
sert the new filter (never try to clean old!) and repeat the steps in reverse order.
The membrane should have no visible damage or undue strain. If necessary replace by the
supplied spare membrane.
Check the condition of three silicone sleeves on the device enclosure. If necessary replace the
sleeves ordering them at the manufacturer.
6-3
6.7 Check and calibration of the FiO2 oxygen sensors and the metabolism measurement module
After each disassembly / assembly of the expiration valve, it is recommended to calibrate flow
sensor at the expiration (it. 4.16.3).
6.7 Check and calibration of the FiO2 oxygen sensors and the metabol-
ism measurement module
The device contains two oxygen sensors - the FiO2 oxygen sensor and the oxygen sensor of
the metabolism measurement module.
To verify the accuracy of measuring oxygen sensors make the following:
• Connect the device to the oxygen source.
• Assemble breathing circuit. Connect patient tee to the respiratory bag through intubation
tube.
• Connect water trap of ventilator with patient tee port by the sampling line.
• Switch on the device in any mandatory ventilation mode, set the tidal volume VT of 400 ml.
• Monitor the FiO2 oxygen sensor readings in one of the measurement parameter blocks (by
selecting the value "FiO2"). The readings of the metabolism measurement module’s oxygen
sensor can be monitored in the respiratory monitoring window "Metabolism" (can be selected
using the graphic button "Monitoring").
• By setting different FiO2 values in the range 21 - 100%, check that the absolute error of the
measured values of FiO2 does not exceed ± 3%.
If the measurement error exceeds ± 3%, disconnect the device from the oxygen source and ca-
librate the oxygen sensors (it. 4.16.2).
If calibration fails, replace oxygen sensors.
Replacement of the oxygen sensor of metabolism measurement module requires disassembly
of the device and can only be performed by qualified personnel authorized by Triton Electronic
Systems Ltd.
Replacement of the FiO2 oxygen sensor can be performed independently. For this purpose un-
screw the two screws of the oxygen sensor cover. Carefully take the inspiratory connector as-
sembly, so as not to break off the wires of the connector. Disconnect the sensor power cable.
By counterclockwise rotating unscrew the faulty sensor (Figure 6.4). Install a new sensor (in
some cases, a spare sensor can be included in the delivery kit). Assemble the inspiratory con-
nector in the reverse order. Calibrate the oxygen sensor (item 4.16.2).
6-4
6.8 Check of built-in accumulator
6-5
6.9 Check of the set tidal volume
• Connect the mainstream CO2 sensor to the device in accordance with it. 5.1. During the cali-
bration procedure, the airway adapter shall be installed in the mainstream CO2 sensor and
disconnected from the breathing circuit.
• Turn on the ventilator, and the mainstream CO2 sensor will also be turned on.
• Wait for sensor warming up (the message about warming on the display disappears).
• Enter [Menu] → [Service menu] → [Calibration] → [CAPNO].
• Select “Zero calibration for MS capno”. During calibration (approximately 30 sec) ensure ab-
sence of CO2 in the measuring chamber of adapter.
• If calibration is successful, the required CO2 measuring accuracy is ensured.
6-7
6.11 Check and calibration of mainstream CO2 sensor
6-8
7. Troubleshooting
7 TROUBLESHOOTING
Name of the fault, external dem- Remedies and recommenda-
Probable cause
onstrations and additional signs tions for further actions
The device does not work from the No mains voltage or voltage is Check the mains voltage in outlet
mains power supply, "Power" LED low
is not illuminated. When operated
Fuses have burned out Check or replace the mains fuses
from the accumulator the alarm
message about the absence of
mains voltage is displayed.
The device does not operate from Accumulator is discharged Charge the accumulator (see it.
the accumulator, the alarm mes- 4.2)
sage about accumulator discharge
is displayed.
"Battery" indicator is red Accumulator or charger is faulty Call for Triton Electronic Systems
Ltd. service or your local repre-
sentative
Alarm message about disconnec- Disconnection of the circuit has Check the tightness of the
tion is displayed happened breathing circuit connections; if
necessary replace the breathing
circuit
Alarm message about occlusion is Breathing circuit, inspiration or Check breathing circuit for occlu-
displayed expiration filter is occluded. sion or compression, check the
inspiration / expiration filters, if
necessary clean
Faulty expiration valve Call for Triton Electronic Systems
Ltd. service or your local repre-
sentative
Alarm message about high oxygen The device is connected to the Connect or replace the filter-
pressure is displayed compressed oxygen source regulator
without the filter-regulator (or fil-
ter-regulator is defective), and
safety valve was triggered (0.25
- 0.35 MPa)
Alarm message about low oxygen Input pressure of oxygen line is Ensure the normal operating
pressure is displayed lower than 0.2 MPa pressure on the device input.
The device has switched into the Technical failure of one or more Call for Triton Electronic Systems
emergency mode. Alarm message modules of the device. Ltd. service or your local repre-
about ventilator replacement and sentative
error codes are displayed
"Fan malfunction" alarm message Fan malfunction (blades don’t Call for Triton Electronic Systems
is displayed rotate) Ltd. service or your local repre-
sentative
If the problem can not be solved by the proposed measures, contact your ser-
vice representative, or customer service of the manufacturer Triton Electronic
Systems Ltd.
7-1
7. Troubleshooting
7-2
8. Transportation 9. Storage 10. Disposal
8 TRANSPORTATION
The device shall be transported in manufacturer packing in a fixed condition by all types of cov-
ered transport without limitation of distance, according to the transportation regulations on the
current type of transport.
Before device transportation under negative temperatures it is necessary to connect the device
to a high pressure air source (4 - 6 kgf/cm2 (bar)), to turn on the device, and leave it for 3 - 5 mi-
nutes operating (CMV/VCV mode, RB = 20 1/min, MV = 30 lpm) for blowing of condensate and
drying of internal lines and the expiration valve.
The device shall be transported at air temperature from -50 to +50 °С.
After transportation under negative temperatures, device should be sustained before unpacking
in normal climatic conditions within 12 hours.
9 STORAGE
The device in manufacturer packing shall be stored in the closed warmed and ventilated room
at air temperature from +5 to +40 °С and relative humidity that not exceed 80 % at temperature
25 °С.
In case of temporary withdrawal, the device shall be stored without manufacturer's packaging in
storehouse at a temperature from +5 °C to +40 °C and relative humidity not more than 80 % (at
a temperature of +25 °C). Devices should be placed on a rack shelf in single line. Do not store
the device in places containing acid-base vapors and vapors of other deleterious substances.
In case of long-term storage after use the device should be placed in polyethylene case and if
possible packaged in manufacturer's packaging way to protect against possible mechanical
damage.
In case of long-term storage of device to maintain its operability carry out tests according Sec-
tion 6 at least every six months. If necessary, accessories with a limited service life should be
replaced. At malfunction the device shall be sent for repair.
When the device is put into storage, the battery shall be charged. Storage of
the device with a discharged accumulator and absense of accumulator train-
ing during storage will lead to premature accumulator failure.
10 DISPOSAL
After end of service life the device should be utilized.
The device shall be disposed in accordance with the local rules for collection, storage and dis-
posal of waste from medical facilities in the country of using the device.
10-1
8. Transportation 9. Storage 10. Disposal
10-2
11. Warranty
11 WARRANTY
11.1 Warranty
These warranty obligations are common and apply to equipment made by Triton Electronic Sys-
tems Ltd. sold and used outside the Russian Federation. Specific obligations for warranty ser-
vice are stipulated in the particular equipment delivery contract and are performed by authorized
service centers of Triton Electronic Systems Ltd. at providing relevant documents.
The warranty for new equipment is provided if the detected malfunction caused by the use of
low-quality materials or violation of the manufacturing technology is properly registered (recog-
nized) by the authorized service center "Triton Electronic Systems" and includes:
• free repair of equipment or its replacement with a similar one in case of impossibility of re-
pair;
• free delivery to an authorized service center.
Terms of warranty repair shall not exceed 20 working days from the receipt of the failed equip-
ment in an authorized service center. The warranty period is extended for the period of time dur-
ing that the equipment was under repair (on the basis of repair data entered in the current Ma-
nual).
The warranty operation period of the new equipment is 12 months and is calculated from the
equipment commissioning date by the authorized service center "Triton Electronic Systems". In
the absence of a note on commissioning in current Manual, the warranty period is calculated
from the date of sale of the equipment under the supply contract, but not more than 18 months
from the date of sale, or, in the absence of the contract, from the date of manufacturing of the
equipment specified on the equipment and in the current Manual. In any case, the warranty op-
eration period can not exceed 18 months from the date of manufacture of the equipment.
For the equipment repaired in the authorized service center there is an additional warranty of 6
months and it is calculated from the date of completion of the repair specified in the current Ma-
nual. The warranty covers only the repaired modules and units of the device.
Warranty obligations do not apply to disposables supplied with equipment. Complaints on them
shall be sent to the respective manufacturer. Also the warranty does not apply to the expiration
of disposables from delivery kit.
11-1
11.Warranty
In case of event that the service center receives warranty equipment that does
not contain defects declared by the buyer, company reserves the right to
charge payment for delivery, testing and after-sales service of the equipment.
11-2
12 Certificate of acceptance
12 CERTIFICATE OF ACCEPTANCE
Intensive Care Ventilator MV200 serial No _________________________ , software
kit No_________________________ complies with the technical specifications
TESM.941144.001 TU and considered suitable for operation.
Date of manufacturing____________________
QC stamp
QC representative________________/___________________/
signature name
stamp
stamp
12-1
13 commission date mark
12-2
14.1 Device maintenance (MA)
14-1
14 Maintenance and repair data
14-2
Appendix 1.1 Description of CMV / VCV mode
PEEP
Flow
Figure. App. 1.1 – Graphs of pressure (top) and flow (bottom) in CMV / VCV modes with de-
creasing flow. The shaded area shows volumes of both inspiration and expiration
In the CMV/VCV mode possibility of support of the spontaneous breaths initiated by the patient
is provided. This possibility is realized by setting of the trigger sensitivity. Automatic breath is
triggered when trigger operates within a trigger window.
In CMV/VCV modes user also can set the inspiration pause by Tplat parameter.
App.1-1
Appendix 1.2 Description of CMV / PCV mode
P
Pi
PEEP
Flow
Figure App. 1.2 – Graphs of pressure (top) and flow (bottom) in CMV / PCV modes
In the CMV/PCV mode possibility of support of the spontaneous breaths initiated by the patient
is provided. This possibility is realized by setting of the trigger sensitivity. Automatic breath is
triggered when trigger operates within a trigger window.
App.1-2
Appendix 1.3 Description of SIMV/VC, SIMV/PC, SIMV/DC modes
TrigWnd = 20 % PEEP
Flow Fmax t
ETS,
% from Fmax
App.1-3
Appendix 1.4 Description of CPAP+PS mode
App.1-4
Appendix 1.5 Description of BiSTEP mode
P(t)
Phigh
PS
Plow
Case 2 - the total pressure Plow + PS is more than pressure of the high phase Phigh, the pres-
sure curve has the following form (see Figure App. 1.4):
P(t)
PS
Phigh
Plow
Thigh Tlow
Figure App. 1.4 – Airway pressure curve
At the detection of spontaneous inspiration in any phase, spontaneous inspiration support will
be up to the same pressure. Tidal volume receiving by the patient will vary depending on the
phase of spontaneous breath.
BiSTEP mode at the appropriate parameter settings can replace CMV/PCV, SIMV/PC modes.
The operation of device is close to the CMV/PCV mode under the following conditions: sponta-
neous respiratory patient's contribution is small, respiratory rate is quite high (it means time
Thigh corresponds to the physiological inspiratory time 0.5 - 1.5 seconds) and Thigh/Tlow ratio
is selected in the range of 1 - 3. The difference is that any spontaneous breath will be supported
with the pressure.
P(t)
PS
Phigh
Plow
Thigh Tlow
Figure App. 1.5 – Pressure support of spontaneous inspiration
The operation of device is close to the SIMV/PC mode (see Figure App. 1.6) if Thigh time cor-
responds to the physiological inspiratory time (0.5 - 1.5 seconds), the selected Thigh/Tlow ratio
is 3 or more, and respectively the hardware breaths frequency is smaller:
App.1-6
Appendix 1.5 Description of BiSTEP mode
P(t)
PS
Phigh
Plow
Thigh Tlow
The difference is that any spontaneous breath in the low or high pressure phase is supported
with the pressure.
At the inverse ratio of high and low pressure phases, Thigh/Tlow<1, the operation of device ap-
proximates to the APRV mode:
P(t)
PS
Phigh
Plow
Thigh Tlow
Figure App. 1.7 – The operation of device is approaching to the APRV mode
App.1-7
Appendix 1.6 Description of NIV mode
App.1-8
Appendix 1.7 Description of APRV mode
Phigh
Plow
Thigh Tlow
APRV mode allows to release the lungs from the reserve gas with specified intervals due to the
low pressure phase Tlow.
Restoring of the previous level of PEEP in the beginning of Thigh phase is performed by fresh
gas without carbon dioxide, thereby eliminating the above premise for hypercapnia.
So APRV mode allows to replace periodically the residual gas in the lungs, improving excretion
of carbon dioxide.
APRV mode has an important difference from BiSTEP that lies in two aspects:
• In APRV mode the low pressure phase Tlow should be significantly shorter than the high
pressure phase Thigh, but sufficient for the residual gas exhalation from the lungs.
• In the low pressure phase spontaneous breaths support is not performed to ensure a com-
plete elimination of gas from the lungs.
In other aspects APRV mode is similar to CPAP+PS, but the support pressure count is made
from pressure Phigh. Limiting of circuit pressure is performed by level (Phigh + PS + 5) cmH2O.
App.1-9
Appendix 1.8 Description of PCV-VG mode
App.1-10
Appendix 1.9 Description of APNEA mode
App.1-11
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
The application of iSV for newborn patients has not been sufficiently stu-
died. Therefore the selection of the iSV mode is blocked for patients with
height up to 57 cm or weight up to 5 kg.
App.1-12
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
Figure App. 1.9 – Inspiration volume (vertical scale) vs. respiratory rate (horizontal scale) for
current MV
The square on the graph represents the limits of safe ventilation. If the calculated RB or Vt are
beyond the square, the ventilator limits these parameters. In this case the output frequency and
volume control setting are provided with safe ventilation limits. At the restrictive disease (low
compliance) the square takes the form of a horizontal rectangle, and at the obstructive patholo-
gy (high resistance, high compliance) the square becomes vertical (without autoscaling).
App.1-13
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
App.1-14
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
App.1-15
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
Appendix 1.10.8 General description of the iSV pattern mode adjustment algorithm
Throughout the iSV operation Otis equation is solved for each breathing cycle. The findings are
limited by the boundaries of the safe ventilation. Calculated data are necessary both for hard-
ware and spontaneous breaths.
Graphically the automatic transition from the mandatory ventilation to supporting one looks as
follows:
Figure App. 1.10 – Graphical representation of the automatic transition from mandatory ventilation
to assisted
If the patient in iSV mode has no spontaneous breathing, the device carries out mandatory ven-
tilation. The parameters of breaths are calculated in real time by the Otis equation. Hardware
breaths are performed in the double control mode.
The second part of the mode reminds CPAP+PS, but the volume of supporting breaths is regu-
lated automatically through the pressure. If the spontaneous breath occurs, pressure support
PS is provided.
At the moments of spontaneous respiratory activity, spontaneous breaths are notable for their
uneven depth and lability of their frequency. Control of the hardware and supporting breaths is
made by different algorithms.
The bottom limit for the mandatory breaths is 5 cmH2O. The bottom limit for the PS breaths is
also 5 cmH2O. This pressure is required to compensate the resistance of the endotracheal tube,
breathing circuit and filters.
App.1-16
Appendix 1.10 Description of the intelligent adaptive ventilation iSV
App.1-17
Appendix 1.11 Selection of ventilation modes at the patient's disturbance and cough
P(t) cough
Pmax
t1
At time t1 cough is superimposed to the inspiration process. The pressure in the circuit sharply
increases and reaches Pmax. In response the device limits the pressure in the circuit at Pmax
level and stops the inspiration by giving freedom of action to the patient, and triggers the alarm.
Proper installation of Pmax level on 10 - 15 cmH2O above the inspiratory pressure creates re-
serve pressure and usually prevents the achievement of Pmax and alarm triggering. However at
the intense coughing this measure is not always effective, alarms can be generated frequently.
It can distract and annoy the staff and even lead to a reduction in its vigilance.
In such a situation it is recommended to select ventilation modes with pressure control
(CMV/PCV, SIMV/PC), that are more resistant to pressure drops. The airway pressure curve
will have the form (see Figure App. 1.12):
cough
P(t)
Pin
PEEP
t
t1
Figure App. 1.12 – Cough in pressure control modes
In these modes, if the cough occurs at the time of inspiration, the device produces a pressure
limit by opening the desired degree of the expiration valve, thus giving the patient the possibility
to exhale. The device keeps the pressure on the level of Pi and do not generate alarms. If
cough occurs in the expiratory phase, device holds pressure at the PEEP level by opening the
expiration valve.
App.1-18
Appendix 2.1 Compliance and resistance
App.2-1
Appendix 2.3 Mean pressure in the circuit for the respiratory cycle (Pmean)
P(t)
autoPEEP
t1 t2 t3 t4
Appendix 2.3 Mean pressure in the circuit for the respiratory cycle
(Pmean)
Mean pressure for the respiratory cycle in the breathing circuit is calculated as follows:
1 T
Pmean = ⋅ ∫ P(t) ⋅ dt ,
T 0
where: Pmean – mean pressure in the circuit for the respiratory cycle,
T – period of the respiratory cycle,
P(t) – pressure in the circuit in the moment of time t.
App.2-2
Appendix 2.4 Time constant of the respiratory tract (τexp, τinsp)
Expiration
F(t)
Low phase
t1
t0
Figure App.2.2 – Time constant on inspiration
Under the conditions of passive expiration, as a first approximation, expiratory flow is described
by the exponential law (RC-circuit model):
F = Fmax exp(-τexp/t) (1),
where: Fmax – peak expiratory flow,
τexp – time constant.
Volume during expiration:
V(t) = Vexp(1 – exp(-τexp / t)) (2),
where: V(t) – current expiration volume,
Vexp – total expiration volume.
Equation (2) shows that texp is a time during that 63 % of the expiration volume Vexp is re-
moved from the lungs.
Expiration process can be divided into 3 stages:
1) The release of the gas from the circuit.
App.2-3
Appendix 2.5 Work of breathing (WOB)
2) The gas flow from the upper respiratory tract, "fast" areas of lungs.
3) The gas flow from the "slow" areas of the lungs.
Stages 2, 3 relate to the slow phase.
This partition is conditional. The stages can be combined and occur simultaneously for certain
values of resistance, compliance and ventilation parameters.
Calculation of τexp is performed by the formula (1) by the method of least squares based on data
about the flow received during passive expiration. This eliminates the step of gas releasing from
the circuit, and the calculation is made for the most informative "slow" part of the flow curve. The
following figure shows typical expiratory flow curves for different values of resistance
(R = 5 cmH2O/l/s and R = 50 cmH2O/l/s).
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2
0
R=5
B B
-10
R = 50
-20
A
-30
л/мин
F,F, lpm
-40
-50
A
-60
-70
t,t,sс
Figure App.2.3 – Graphs of flow on inspiration for patients with different resistance values
Portions of the curve (0-A) are discarded, measurement is carried out in the area A-B. Evalua-
tion of the correctness of τexp values is carried out by calculating the confidence factor of flow
curve approximation that should be at least 0.6. Otherwise the measurement is considered to
be misleading and dashes (--) are displayed instead of the R.
Average value of the time constant of the section A-B is calculated using this procedure. It takes
into account the resistance of the patient's lungs, the resistance of the endotracheal tube and
the resistance of the expiraiton valve.
Measurement of τexp is performed on the each expiration; the averaging is made over the last 4
cycles.
App.2-4
Appendix 2.6 Rapid shallow breathing index (RSBI)
2
Ranieri, V. M., H. Zhang, L. Mascia, M. Aubin, C. Y. Lin, J. B. Mullen, S. Grasso, M. Binnie, G. A. Volgyesi, P. Eng, and A. S.
Slutsky. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology 2000;
93:1320-1328.
App.2-5
Appendix 2.7 Stress index (SI)
I II III
Figure App.2.4 – Volume control: pressure graphs at normal (SI = 1), low (SI < 1) and high
(SI>1) stress-index
A
P
Figure App. 2.5 – at the correctly selected PEEP the pressure increases linearly
If PEEP and Vt values are selected properly, the whole range of the inspiratory pressure values
lies on the linear part of the curve V (P), between points A and B (case I).
The idea of Ranieri - under these conditions the pressure in the circuit should increase accord-
ing to the following law:
P(t) = a×tb + c,
where: c – corresponds to the pressure at the beginning of the inspiration (point A),
b – stress index SI.
At b=1 the equation becomes linear.
Appendix 2.8 Patient’s respiratory effort P0.1
The value P0.1 characterizes the patient's ability to the independent breathing. P0.1 value is the
pressure difference between the moment of start of the inspiration (t = 0) and moment of com-
pletion of 100 ms in the occluded circuit. This pressure difference is generated by the inspiratory
effort of the patient. P0.1 measurement is valuable for the physician in the specific conditions of
patient’s ventilation and performed by the device with the current settings of the inspiratory trig-
ger. Change of sensitivity or trigger type will change the moment of activation of the inspiratory
trigger and is likely will change the measured value of P0.1.
App.2-6
Appendix 2.7 Stress index (SI)
P(t)
Beginning of
inspiration 100 ms
P(t0)
P(t100)
t0 t100
Figure App.2.6 – Measuring of P0.1 parameter
If pressure in the circuit at the time t100 has fallen no lower than 1 cmH2O as a result of the pa-
tient’s efforts and there is no inspiratory flow, the P0.1 is calculated as follows:
P0.1 = P(t100) - P(t0)
If the pressure has dropped below 1 cmH2O, compliance and correction associated with flow
are added to the calculated value.
App.2-7
Appendix 2.9 Ideal body weight of the patient (IBW)
Table App. 2.1 – Centile tables for boys and girls under the age of 2 years.
0 - 2 years, average (0-2 years Median th. (WHO)) 0 - 2 years, average (0-2 years Median th. (WHO))
Height, cm Weigth, kg Height, cm Weigth, kg
Boys Girls Boys Girls
45 2.4 2.5 86 11.7 11.5
46 2.6 2.6 87 12.0 11.7
47 2.8 2.8 88 12.2 12.0
48 2.9 3.0 89 12.5 12.2
49 3.1 3.2 90 12.7 12.5
50 3.3 3.4 91 13.0 12.7
51 3.5 3.6 92 13.2 13.0
52 3.8 3.8 93 13.4 13.2
53 4.0 4.0 94 13.7 13.5
54 4.3 4.3 95 13.9 13.7
55 4.5 4.5 96 14.1 14.0
56 4.8 4.8 97 14.4 14.2
57 5.1 5.1 98 14.6 14.5
58 5.4 5.4 99 14.9 14.8
App.2-8
Appendix 2.9 Ideal body weight of the patient (IBW)
For the children with height from 130 to 150 cm ideal body weight is calculated as for the adult
patients.
App.2-9
Appendix 2.9 Ideal body weight of the patient (IBW)
App.2-10
Appendix 3 Electromagnetic environment
± 1 kV line(s) to ± 1 kV line(s) to
Surge Mains power quality should be
line(s); line(s);
that of a typical commercial or
IEC 61000-4-5:2005 ± 2 kV line(s) to hospital environment.
± 2 kV line(s) to earth
earth
Voltage dips, short <5 % UT <5 % UT Mains power quality should be
interruptions and (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial or
voltage variations for 0.5 cycle for 0.5 cycle hospital environment. If the
user of the ventilator requires
on power supply
continued operation during
input lines 40 % UT 40 % UT power mains interruptions, it is
IEC 61000-4- (60 % dip in UT) (60 % dip in UT) recommended that the ventila-
11:2004 for 5 cycles for 5 cycles tor be powered from an unin-
terruptible power supply or a
70 % UT 70 % UT battery.
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) for 5 (>95 % dip in UT) for
s 5s
App.3-1
Appendix 3 Electromagnetic environment
Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment – guidance
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels cha-
magnetic field racteristic of a typical location
in a typical commercial or hos-
IEC 61000-4-8:2009
pital environment.
No te . U T is th e a .c . m a ins v o l ta g e pr i or to a pp l ic at i on of t he t es t l ev e l .
Conducted RF 3 Vrms 3 V Portable and mobile RF com-
IEC 61000-4-6:2008 150 kHz to 80 MHz munications equipment should
Outside industrial, be used no closer to any part
scientific and medical of the ventilator, including
(ISM) bands
1) cables, than the recommended
separation distance calculated
from the equation applicable to
10 Vrms 10 V the frequency of the transmit-
150 kHz to 80 MHz ter.
1)
in ISM bands Recommended separation
distance
d = 1.2 P
d = 1.2 P
Note 1. At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mo-
bile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with ac-
curacy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ventilator is used exceeds the appli-
cable RF compliance level above, the ventilator should be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary, such as re-orienting or relocating the ventilator.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
App.3-2
Appendix 3 Electromagnetic environment
App.3-3
Appendix 3 Electromagnetic environment
App.3-4
Appendix 4 Pneumatic scheme of ventilator
App.4-1
Appendix 4 Pneumatic scheme of ventilator
App.4-2
Appendix 5 Technical malfunction and events
App.5-1
Appendix 5 Technical malfunction and events
App.5-2
Appendix 6 DELIVERY SET
App.6-1
Appendix 6 DELIVERY SET
App.6-2
Appendix 6 DELIVERY SET
App.6-3
Appendix 6 DELIVERY SET
2 Spare parts:
App.6-4
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
1. General features
Adults, children, newborn with body weight
1.1. Type of patients
from 2 kg
Built-in flow generator “turbine”. Electric,
1.2. Type of drive compressorless. The device is independent
from the compressed air sources.
It is allowed to use low-pressure oxygen
1.3. Input oxygen pressure sources with operating pressure range
2
0.5 - 1.5 kgf / cm (bar) (see p. 3.3.5)
Low-pressure oxygen sources with a work-
Operation from a low pressure oxygen sources (option- ing pressure range up to
1.4.
al) 2
0.5 kgf / cm (bar) (see p. 5.8)
All sensors (flow and pressure) are located
inside of the device and protected against
1.5. Position of flow and pressure sensors
water condensation effects and mechanical
damage.
The ability to use accessories, breathing circuits of var-
1.6. Available
ious types, including coaxial
Quick replacing of the oxygen sensor without device
1.7. Available
disassembling
Function of the oxygen sensor calibration:
1.8. - automatic, without interruption of ventilation Available
- service (manual) Available
Disable O2 monitoring and alarm triggering at the oxy-
1.9. Available
gen sensor failure
Ability to ventilate only by air in the absence of oxygen. Available
1.10. Ability to disable the alarm in the absence of oxygen
and ventilation only by air. Available
Control via the touch screen, quick keys
(buttons) for parameters, the regulator of the
1.11. User interaface
"Encoder" type for the quick parameter
changes.
1.12. Log of alarms and events (1000 messages) Available
Automatic calculation of start ventilation parameters
1.13. according to the ideal body weight and patient’s age Available
category
Saving last used mode and ventilation parameters set-
1.14. tings, opportunity to apply them for the next ventilation Available
session.
At the ventilator’s switching testing of all
1.15. The automatic self-test before connecting modules is conducted with the displaying of
the detected faults.
No more than 3 hours with accumulator with
1.16. Built-in accumulator charging time
charge current not less than 2.9 A
Ability to correct delivered tidal volume according to the
1.17. ATP, ATPS, ATPD, BTPS
conditions: temperature, humidity, pressure
Active expiration valve ensures free breathing of the Available
1.18. patient during mandatory breaths.
App.7-1
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
App.7-2
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
App.7-3
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
7.5. Selection of the type of spirometry loops Selection of one of three possible loops
App.7-4
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
App.7-5
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS
App.7-6
GLOSSARY
GLOSSARY
? Failure of compliance and resistance measurement
%MV Factor of increasing/decreasing of target MV in the iSV mode.
τexp Expiratory time constant (RCexp). Time constant determining the potential
rate of pressure change in the lungs during expiratory phase. Calculated pa-
rameter displayed in RESP2 window. τexp = Rexp × Cexp
τinsp Inspiratory time constant (RCinsp). Time constant determining the potential
rate of pressure change in the lungs during inspiratory phase. Calculated pa-
rameter displayed in RESP2 window. τinsp = Rinsp × Cinsp
APNEA Automatic backup ventilation mode in cases of pressure and volume apnea.
Apnea ventilation mode is not fully independent ventilation mode. It is a me-
chanism to ensure patient safety in case of cessation of respiration in modes
with support of the patient's spontaneous breathing. The device automatically
switches to apnea ventilation mode when it detects absence of respiratory
cycles during the set time interval. Functionally, the apnea ventilation mode is
CMV mode with preset parameters, with control or volume control.
Apnea Cessation of ventilator’s and spontaneous breathing.
Gl-1
GLOSSARY
Photoplethysmogram Graph showing the change in tissue transparency in the section of the optical
(PPG) sensor. Transparency of tissues changes due to narrowing and widening of
blood vessels because of pulsating arterial blood.
Pi Inspiratory pressure.
Piapnea Inspiratory pressure above apnea PEEP level in the apnea mode.
PIP Peak inspiratory pressure.
Plateau pressure See Pplat.
Plateau time Selection the measuring units (% or sec).
Gl-4
GLOSSARY
Plimit Value of pressure limitation in the breathing circuit in the iSV mode.
Plow Pressure value in the low pressure phase (in the BiSTEP, APRV modes).
Pm Mean pressure for the respiratory cycle.
Pmax Maximum acceptable inspiratory pressure.
Pmin Minimum acceptable support pressure of spontaneous breaths.
PMM Pressure measurement module (service menu message).
Pplat Plateau pressure. Pressure on the inspiratory pause in volume control modes.
Gl-6
GLOSSARY
Tlow Time of the low pressure phase in the BiSTEP, APRV modes.
Tplat Plateau time
Trigger Threshold value for the detection of spontaneous inspiration. Trigger can oper-
ate by volume and pressure. The lower trigger value means the higher trigger
sensitivity to the air fluctuations in the breathing circuit.
Trigger Vinsp 25 ml Additional criterion for the inspiratory trigger activation at exceeding the inspira-
tory volume of 25 ml, that ensures triggering at slow (prolonged) spontaneous
inspirations.
TrigWnd Trigger window. The trigger window or the fraction of the expiratory time when
a spontaneous inspiration is expected. The expiration is divided into two parts
by the trigger window: 1) the period when ventilator’s expiration shall occur, if
previously there were no spontaneous inspiration attempts 2) a period when
spontaneous inspiration attempts are expected and supported. The value of the
trigger window can be set in percent or seconds, depending on the [Menu]
[Trig.window] parameter.
V Volume. The volume graph shows the volume of the respiratory mixture con-
sumed by the patient in a single breathing cycle.
Valv Alveolar ventilation is lung ventilation minus ventilation of dead space. Normally
the alveolar ventilation is 70 - 75% of MV. Alveolar ventilation is calculated ac-
cording to the formula: MAV = (VT - Vd) × RB, where MAV - minute alveolar
ventilation, VT - tidal volume, Vd - dead space volume , RB - respiratory rate.
Vapnea Tidal volume in the apnea mode.
VCO2 Elimination of СО2 per minute (difference between СО2 concentration in the in-
haled and exhaled mixture).
Volume capnography waveform.
Vd Functional dead space. The inspiratory air volume that almost does not take
part in gas exchange. The default value is calculated as a function of the pa-
tient's growth.
Ventilation controller See CIVL.
Vexp Expiratory volume.
Vinsp Inspiratory volume.
Gl-8