User Manual MV200 - 2nd Edition

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INTENSIVE CARE VENTILATOR

MV200

USER MANUAL

TESM.941144.001-01 UM

2nd edition, 10/2019

4th edition 12/2016


CONTENT

1 INTRODUCTION ................................................................................................. 1-1


1.1 Intended use ..................................................................................................... 1-1
1.2 General guidance ............................................................................................. 1-4
1.3 Symbols and references ................................................................................... 1-5
1.4 Information about resource of the main functional units of the device .............. 1-8
1.5 Revision history ................................................................................................ 1-8
2 DESCRIPTION OF DEVICE ................................................................................ 2-1
2.1 Basic parameters and characteristics ............................................................... 2-1
2.2 Configuration of device ..................................................................................... 2-5
2.3 Front panel ....................................................................................................... 2-9
2.4 Rear panel ........................................................................................................ 2-11
2.5 Transport cart (mobile trolley) ........................................................................... 2-12
3 PREPARING FOR OPERATION ........................................................................ 3-1
3.1 Operating conditions ......................................................................................... 3-1
3.2 Safety precautions ............................................................................................ 3-1
3.3 Preparing for operation ..................................................................................... 3-4
3.3.1 Preparing of the device and accessories .............................................. 3-4
3.3.2 Installation of the electronic unit and the supporting arm ...................... 3-4
3.3.3 Installation of humidifier......................................................................... 3-6
3.3.4 Assembling of the breathing circuit ....................................................... 3-7
3.3.5 Connecting to the oxygen source .......................................................... 3-11
3.4 Device turning on and off .................................................................................. 3-14
3.5 Cleaning, disinfection and sterilization .............................................................. 3-16
3.5.1 Cleaning, disinfection of external parts and non-sterilized components 3-16
3.5.2 Reprocessing of sterilized components ................................................. 3-17
4 DEVICE CONTROL ............................................................................................ 4-1
4.1 Main features of device..................................................................................... 4-1
4.2 Reserve power supply ...................................................................................... 4-3
4.2.1 Built-in accumulator ............................................................................... 4-3
4.2.2 Features of reserve power supply operation ......................................... 4-3
4.3 Controls ............................................................................................................ 4-5
4.4 Starting window. Beginning of ventilation ......................................................... 4-6
4.4.1 Starting window ..................................................................................... 4-6
4.4.2 Window of associated parameters ......................................................... 4-7
4.4.3 Automatic calculation of initial ventilation parameters............................ 4-7
4.4.4 Initial alarm settings ............................................................................... 4-9
4.4.5 Calibration procedure before the beginning of operation ....................... 4-9
4.5 Main window ..................................................................................................... 4-11
4.6 Main menu ........................................................................................................ 4-14
4.7 Setting of ventilation modes and parameters .................................................... 4-15
4.7.1 Ventilation mode selection ..................................................................... 4-15
4.7.2 Changing of parameters. Conflict of parameters ................................... 4-16
4.7.3 View of parameter setting line in the different ventilation modes ........... 4-18
4.7.4 Description of ventilation parameters..................................................... 4-19
4.8 Menu of general ventilation parameters setting ................................................ 4-22
4.8.1 Description of general ventilation parameters ..................................... 4-22
4.8.2 Menu of apnea parameters ................................................................. 4-24
4.8.3 Menu of iSV mode parameters ............................................................ 4-25
4.8.4 Menu of Pmax, Tinsp limits ................................................................. 4-25
4.9 Setting of the type of inspiration trigger ............................................................. 4-26
4.10 Automatic calibration of the oxygen sensor..................................................... 4-27
4.11 Additional functions ......................................................................................... 4-28
4.11.1 Alveolar recruitment maneuver ............................................................ 4-28
4.11.2 Oxygenation ........................................................................................ 4-30
4.11.3 Suction................................................................................................. 4-30
4.11.4 Standby mode ..................................................................................... 4-31
4.11.5 Leak compensation.............................................................................. 4-32
4.11.6 Manual breath (manual ventilation)...................................................... 4-33
4.11.7 Screen lock .......................................................................................... 4-34
4.11.8 "Freezing" / analysis of graphs ............................................................ 4-35
4.11.9 Display brightness control.................................................................... 4-35
4.12 Display settings menu ..................................................................................... 4-36
4.12.1 Graph setting menu ........................................................................... 4-36
4.12.2 Menu of settings of measuring parameter blocks .............................. 4-39
4.13 Menu of view of trends and alarm log ............................................................. 4-40
4.14 Alarm settings menu ....................................................................................... 4-44
4.15 Volume settings menu..................................................................................... 4-46
4.16 Service menu .................................................................................................. 4-47
4.16.1 Function of service menu parameters ................................................. 4-47
4.16.2 Calibration of FiO2 sensor, O2 sensor of metabolism measurement
module .......................................................................................................... 4-51
4.16.3 Expiratory flow sensor calibration ........................................................ 4-53
4.16.4 Selection of flow correction conditions on the inspiration and
the expiration.................................................................................................. 4-54
4.16.5 Breathing circuit calibration ................................................................. 4-54
4.17 Alarms ............................................................................................................ 4-57
4.17.1 High priority alarms ............................................................................. 4-59
4.17.2 Medium priority alarms ........................................................................ 4-61
4.17.3 Low priority alarms .............................................................................. 4-63
4.17.4 Informational messages ...................................................................... 4-65
4.17.5 Special alarms of iSV mode ................................................................ 4-66
4.17.6 Emergency and technical failure modes.............................................. 4-66
4.18 Extended respiratory monitoring ..................................................................... 4-69
4.19 Features of using antibacterial and heat and moisture exchange filters ......... 4-71
4.20 Nebulizer ........................................................................................................ 4-72
4.21 "Open valve" function ..................................................................................... 4-75
5 OPTIONAL FEATURES OF THE DEVICE ......................................................... 5-1
5.1 Mainstream CO2 sensor (capnometer) ............................................................. 5-1
5.2 Volume capnometry .......................................................................................... 5-5
5.3 Cardiac output by Fick ...................................................................................... 5-7
5.4 Pulse oximetry module ..................................................................................... 5-9
5.5 Metabolism measurement module .................................................................... 5-14
5.6 Compensation of endotracheal tube resistance................................................ 5-19
5.7 “Auxiliary external pressure” function................................................................ 5-20
5.8 Operating with low pressure oxygen source ..................................................... 5-24
5.9 Data exchange with computer .......................................................................... 5-25
6 MAINTENANCE OF THE DEVICE ...................................................................... 6-1
6.1 Maintenance schedule ...................................................................................... 6-1
6.2 Visual inspection and test of controls ............................................................... 6-2
6.3 Cleaning and replacement of fan filters ............................................................ 6-2
6.4 Check of sealing gaskets .................................................................................. 6-2
6.5 Check of the filter-regulator .............................................................................. 6-3
6.6 Check of the expiration valve............................................................................ 6-3
6.7 Check and calibration of the FiO2 oxygen sensors and the metabolism
measurement module ............................................................................................. 6-4
6.8 Check of built-in accumulator ............................................................................ 6-5
6.9 Check of the set tidal volume ............................................................................ 6-6
6.10 Check of PEEP ............................................................................................... 6-6
6.11Check and calibration of mainstream CO2 sensor............................................ 6-6
7 TROUBLESHOOTING......................................................................................... 7-1
8 TRANSPORTATION............................................................................................ 10-1
9 STORAGE ........................................................................................................... 10-1
10 DISPOSAL ......................................................................................................... 10-1
11 WARRANTY ...................................................................................................... 11-1
11.1 Warranty ......................................................................................................... 11-1
11.2 Guarantee procedure ...................................................................................... 11-2
11.3 Address for notes and complaints ................................................................... 11-2
12 CERTIFICATE OF ACCEPTANCE ................................................................... 12-1
13 COMMISSION DATE MARK ............................................................................. 12-1
14 MAINTENANCE AND REPAIR DATA .............................................................. 14-1
14.1 Device maintenance (MA) ............................................................................... 14-1
14.2 Device repair ................................................................................................... 14-1
APPENDIX 1 DESCRIPTION OF VENTILATION MODES .................................... App.1-1
Appendix 1.1 Description of CMV / VCV mode ....................................................... App.1-1
Appendix 1.2 Description of CMV / PCV mode ....................................................... App.1-2
Appendix 1.3 Description of SIMV/VC, SIMV/PC, SIMV/DC modes ....................... App.1-3
Appendix 1.4 Description of CPAP+PS mode ......................................................... App.1-4
Appendix 1.5 Description of BiSTEP mode ............................................................. App.1-5
Appendix 1.6 Description of NIV mode ................................................................... App.1-8
Appendix 1.7 Description of APRV mode ............................................................... 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 ...................... App.1-12
Appendix 1.10.1 Function of iSV mode. General description ...................... App.1-12
Appendix 1.10.2 Assessment of respiratory rate .......................................... App.1-13
Appendix 1.10.3 Assessment of the tidal volume ......................................... App.1-13
Appendix 1.10.4 Limits of the safe iSV ventilation. General concepts .......... App.1-13
Appendix 1.10.5 I:E ratio, medical aspects................................................... App.1-14
Appendix 1.10.6 Calculation of the respiratory cycle phases (I:E) ............... App.1-14
Appendix 1.10.7 Start of iSV mode .............................................................. App.1-15
Appendix 1.10.8 General description of the iSV pattern mode adjustment
algorithm ...................................................................................................... App.1-16
Appendix 1.10.9 Function of MV adaptation ................................................ App.1-17
Appendix 1.10.10 Pmin parameter ............................................................... App.1-17
Appendix 1.11 Selection of ventilation modes at the patient's disturbance and
cough ........................................................................................................... App.1-18
APPENDIX 2 METHODS OF DETERMINING PARAMETERS ............................. App.2-1
Appendix 2.1 Compliance and resistance............................................................... App.2-1
Appendix 2.2 AutoPEEP ......................................................................................... App.2-1
Appendix 2.3 Mean pressure in the circuit for the respiratory cycle (Pmean) ......... App.2-2
Appendix 2.4 Time constant of the respiratory tract (τexp, τinsp) ........................... App.2-3
Appendix 2.5 Work of breathing (WOB) ................................................................. App.2-4
Appendix 2.6 Rapid shallow breathing index (RSBI) .............................................. App.2-5
Appendix 2.7 Stress index (SI) ............................................................................... App.2-5
Appendix 2.9 Ideal body weight of the patient (IBW) .............................................. App.2-8
APPENDIX 3 ELECTROMAGNETIC ENVIRONMENT .......................................... App.3-1
APPENDIX 4 PNEUMATIC SCHEME OF VENTILATOR ...................................... App.4-1
APPENDIX 5 TECHNICAL MALFUNCTION AND EVENTS ................................. App.5-1
Appendix 5.1 Technical malfunction ....................................................................... App.5-1
Appendix 5.2 Technical messages ......................................................................... App.5-2
APPENDIX 6 DELIVERY SET .............................................................................. App.6-1
APPENDIX 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS ............. App.7-1
GLOSSARY ........................................................................................................... Gl.-1
1.1 Intended use

1 INTRODUCTION

1.1 Intended use


Intensive care ventilator MV200 (hereinafter – device, ventilator) is intended for carrying out
controlled and assisted artificial ventilation of lungs for all patient groups with tidal volume from
10 ml dependent on artificial ventilation in resuscitation units, surgery and intensive care de-
partments of professional medical facilities, and also at transportation within professional medi-
cal facilities.
Ventilation modes of device are in detail described in it. 4.1 and the Appendix 1.

Figure 1.1 - Appearance of the device

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

1.2 General guidance


The current User manual is a component of the device and the mandatory part of the delivery
set. This document is provided only for information purposes, it is prohibited to copy, reproduce,
translate it into other language, to keep in the information retrieval system, to transmit in any
form or by any means or to transform to a form suitable for storage on electronic data carriers
without the prior written permission of the manufacturer. Information contained in this document
can be changed without notice.
Before starting of operation with the device attentively read current manual. Remember that mi-
shandling can cause performance deterioration of the device, its malfunction and safety hazard
for the patient.
At malfunction or unstable operation of the device, firsty it is necessary to address to the list of
possible malfunctions and methods of their elimination (see Section 7), and also to appropriate
sections of the present User manual.
In the current User manual the following designations are used:

This information is necessary to know to avoid injuries of patient or per-


sonnel.

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

1.3 Symbols and references


The symbols used on the enclosure of the device

Marking of Conformity to European Medical Device Directive

Caution!

Refer to accompanying documents!

Applied part of ВF type

Applied part of В type

Mark of conformity of the Directive 2002/92/EG

Serial number

Date of manufacture

Manufacturer

Authorized representative in EU

IP 21 Type of enclosure protection from ingress of water and solid particles

General sign of prohibition

Alternative current

Mains power switch

Sound alarm pause button

The button calling the menu window, cancellation of parameter set, menu exit etc.

The button calling the menu of additional functions (nebulizer)

The button calling the delayed alarms log

Oxygen inlet, necessary operating pressure 0.15…0.6 MPa

Additional oxygen inlet for connection to the low-pressure oxygen source (optional)

Outlet of the exhausted gas mixture

Port for connection of the inspiratory line of the breathing circuit

Port for connection of the expiratory line of the breathing circuit

1-5
1.3 Symbols and references

Equipotentiality

Port for connection of the mainstream CO2 sensor

Ethernet Connector for the local information network by the standard Ethernet protocol

Connector for USB Flash memory devices

T2.0AL/250V Mains power fuse

Connector for the pulse oximetry sensor

Connector for the pneumatic nebulizer

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)

Symbols on the transport cart

Symbols warning of the overturning danger (see p. 3.2)

Symbols and icons on the ventilator screen

General and patient symbols

Open/Close menu window button

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)

Indicator of patient’s spontaneous inspiration attempts

Measurement of a compliance and resistance button

adult “Adult” type of patient

child “Child” type of patient

IBW Ideal body weight

ET (TST) Endotracheal (tracheostomy) type of tube

Icons

Sound alarm off

1-6
1.3 Symbols and references

Oxygenation

Standby mode

Alveolar recruitment maneuver

Suction

Leak compensation

Manual breath (manual ventilation)

“Freezing”/ analysis of graphs

Screen lock

Display brightness control

Graphs

Flow Flow graph

iSV Graph of iSV mode

Paux Auxiliary external pressure graph

Paw Airway pressure graph

PCО2 Capnogram

Oxigram for operating with the metabolism measurement module (calculated as the dif-
PО2
ference FiO2 - EtO2)

REF Reference loop

SpO2 Photopletismogram

VCO2 Volume capnography graph

Vol Volume waveform

V-F Volume/ Fow loop

V-P Volume/ Pressure loop

F-P Flow/ Pressure loop

V-Paux Volume / Auxiliary pressure loop

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

2.1 Basic parameters and characteristics


No Parameter Value (description)

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

No Parameter Value (description)

Continuous mandatory ventilation with the controlled


2.2 pressure of inspiration (synchronized ventilation with CMV/PCV
pressure control)
Synchronized intermittent mandatory ventilation with
2.3 flow trigger or pressure trigger with volume control SIMV/VC
with pressure support of spontaneous breaths (PS)
Synchronized intermittent mandatory ventilation with
2.4 flow trigger or pressure trigger with pressure control SIMV/PC
with pressure support of spontaneous breaths (PS)
Synchronized intermittent mandatory ventilation with
2.5 flow trigger or pressure trigger with double control with SIMV/DC
pressure support of spontaneous breaths (PS)
Spontaneous breathing with continuous positive air-
2.6 way pressure with pressure support of spontaneous CPAP+PS
breaths (PS)
Spontaneous breathing with two levels of continuous
2.7 positive airway pressure with pressure support of BiSTEP
spontaneous breaths (PS)
2.8 Airway pressure release ventilation APRV
Pressure controlled ventilation with guaranteed respi-
2.9 PCV-VG
ratory volume
2.10 Non-invasive ventilation of lungs NIV
2.11 Intellectual support ventilation (option) iSV
Automatic backup ventilation mode in cases of pres-
2.12 APNEA
sure and volume apnea.
3 Ventilation parameters
Tidal volume, Vt 10 - 3000 ml
Measuring accuracy :
3.1
In range 10-100 ml ±(2+0.05Vt) ml abs
In range 100-3000 ml ±8 % rel
3.2 Minute volume, MV 0 - 60 lpm
Rate of breathing / respiratory rate (controlled respira-
3.3
tory cycles), RB: 1 - 120 1/min
Frequency of mandatory breaths at synchronized in-
3.4 1 - 60 1/min
termittent assisted ventilation, RB
Waveform of the gas flow in the ventilation modes with
3.5 Rectangular, descending
volume control, FormFlow
3.6 Periodic enhanced inspiration Available
3.7 I:E ratio 1:99 - 60:1
0-5s
3.8 Plateau time, Tplat
0 - 70 % from inspiratory time
3.9 Support pressure of spontaneous breath, PS 0 - 80 cmH2O (mbar)
3.10 Positive end-expiratory pressure, PEEP 0 - 50 cmH2O (mbar)
3.11 Inspiratory pressure, Pi 0 - 100 cmH2O (mbar)
3.12 Inspiratory time, Tinsp 0.2 - 10 s
0 - 100 %
3.13 Trigger window, TrigWnd
0.5 - 4 s
3.14 Flow trigger sensitivity, Ftrig 0.5 - 20 lpm
3.15 Pressure trigger sensitivity, Ptrig 0.5 -20 cmH2O (mbar)
2-2
2.1 Basic parameters and characteristics

No Parameter Value (description)

3.16 Expiration trigger sensitivity, ETS 5 - 80 %


Periods of low pressure 0.5 - 30 s, 0 -35 cmH2O (mbar)
3.17
and high pressure 1 - 30 s, 0 -70 cmH2O (mbar)
Gas leakage from the breathing circuit
- at the pressure of 50 cmH2O (mbar) Up to 0,2 lpm
3.18
- at the pressure of 40 cmH2O (mbar) Up to 0,1 lpm
- at the pressure of 20 cmH2O (mbar) Up to 0,05 lpm
3.19 Fractional concentration of inspired oxygen, FiO2 21 - 100 %
3.20 Maximum acceptable inspiratory pressure, Pmax 105 cmH2O (mbar)
3.21 Time of transition to the apnea mode, Tapnea 10 - 60 s
3.22 Pressure drop of the device in passive exhalation line Up to 2 cmH2O (0,2 kPa)
When the device is switched off the possibility of
3.23 spontaneous breathing of the patient through the de- Available
vice is provided.

4 Parameters of basic respiratory monitoring

Peak inspiratory pressure


4.1 PIP
indication range 0-100 cmH2O (0-10 kPa)
Positive end-expiratory pressure (the minimum pres-
4.2 sure in the circuit) PEEP
indication range 0-50 cmH2O (0-5 kPa)
Minute volume of breathing
4.3 MV
indication range 0-60 lpm
Expiratory volume
4.4 Vexp
indication range 0-6000 ml
Inspiratory volume
4.5 Vinsp
indication range 0-6000 ml
Respiratory rate
4.6 RB
indication range 0-120 1/min
Inspiratory:expiratory ratio
4.7 I:E
indication range 1:99 ÷60:1
Fractional concentration of inspired oxygen
4.8 FiO2
indication range 0-100 %
Static compliance (ml/cmH2O)
4.9 indication range: - lower value maximum 10 Сst
upper value minimum 90
Static resistance (cmH2O/l/s)
4.10 indication range: - lower value maximum 0 Rst
upper value minimum 200

Concentration (partial pressure) of CO2 in the inhaled


4.11 and exhaled gas mixture (option) FiCO2, EtCO2
indication range 0-15 % (0-115 mm Hg)

Oxygen saturation of arterial blood hemoglobin (op-


4.12 tion) SpO2
indication range 10-100 %

2-3
2.1 Basic parameters and characteristics

No Parameter Value (description)

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.

Functional characteristics and parameters of the device depend on deli-


very specification.

The list of additional parameters and characteristics is presented in Ap-


pendix 7.

2-4
2.2 Configuration of device

2.2 Configuration of device


1 Electronic unit

2 Filter-regulator
TESM.186143
for connection of the device to the compressed
oxygen.

3 Mobile trolley (transport cart)


TESM.186307-01 for installation and transporta-
tion of the electronic unit.
• TESM.186307-01
• TESM.186307

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

6 Supporting arm for the breathing circuit


TESM.189015
for fixing of the breathing circuit. Mounted on the
transport cart.

7 Humidifier of breathing mixtures for ventila-


tors with accessories
(available on request)

8 Breathing circuit (patient circuit)


Adult, pediatric (including by special order sili-
cone, coaxial, disposable or reusable)

9 Respiratory (virus-bacterial) heat and mois-


ture exchanging filter, 22F (HME filter)
for assembling of the breathing circuit

10 Respiratory filter (virus-bacterial), Luer-


Lock
used during measuring the auxiliary external
pressure
(option)
11 Breathing bag (test lung), 3L, 22F or 0.5 L
10(15)F
for functional test of device before connection to
the patient

12 Sidestream airway adapter


for the connection of metabolism measurement
module with a breathing circuit
Monitoring line
with Luer-Lock
for the connection of the oximeter channel of me-
tabolism measurement module with the breathing
circuit.
2-6
2.2 Configuration of device

Also used during measuring the auxiliary external


pressure
13 Mainstream CO2 module including:
• mainstream CO2 sensor TESM.506001;
• airway adapter adult/pediatric TESM.706020;
• airway adapter pediatric/neonatal
TESM.706021

14 Pulse oximetry sensor


• RM501.00.124-01 (finger, clip)
• RM501.00.004-01 (neonatal, universal)
(option)

15 Nebulizer (sprayer of inhalation solutions)

16 Mask for non-invasive ventilation


(available on request)

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

19.4 Dust filter


TESM.009926 for the replacement in the cooling
fan and fresh gas intake fan

19.5 Water trap


for the replacement in the oximeter channel of
the metabolism measurement module

19.6 Ring
TESM.049124 for the replacement in the screwed
cap of filter-regulator for connection to the “O2” in-
let port.

Some items may be optional, depending on the functional configuration of


the device and the supply agreement. Check the delivery kit of your device
according to the packing list.

2-8
2.3 Front panel

2.3 Front panel

Figure 2.1 – Front view of the electronic unit

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

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

Figure 2.2 – Back view of the ventilator


2-11
2.5 Transport cart (mobile trolley)

2.5 Transport cart (mobile trolley)


Since some details (the panel, handle, wheels) are transported in the disassembled state, be-
fore using assemble it according to the Figure 2.3.

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

Figure 2.3 – Transport cart a) TESM.186307-01, b) TESM.186307


At installation of the transport cart it is necessary to use all three screws to
secure the electronic unit to the ventilator’s installation table to prevent the
electronic unit from falling in case of careless transportation.
Do not use the cart if damage is found. Contact your service representative
for assistance.

2-12
3.1 Operating conditions

3 PREPARING FOR OPERATION

3.1 Operating conditions


• Ambient air temperature +10…35 ºС.
• Relative humidity 40…80 % (at the air temperature +25 ºС).
• Atmospheric pressure 600 ... 800 mmHg.
• Placement of the device is selected in accordance with connections to the mains and to the
patient. The distance from the rear panel of the device to the wall or any other large obstruc-
tion should be at least 10 cm.
• Connect the device only to the three-pole mains power outlet with the operating protective
grounding. It is not allowed to switch the device into the wall outlet without grounding.
• In the case of joint operation of device with electrosurgical instruments for stable operation
connect the potential equalization wire to the potential equalization terminal - see Figure 2.2,
position 5. It is not allowed to switch the device simultaneously with other electrical devices in
one multi-outlet power connector.
• The device must be connected to the high pressure source of the compressed oxygen (cy-
linder with reducer or distribution system of medical facility) with pressure 0.15 - 0.6 MPa and
capacity at least 100 lpm. In the optional version (supplied by special order) device can be
connected to the low pressure oxygen source.

3.2 Safety precautions


• Concerning safety, the device complies with IEC 60601-1, ISO 80601-2-12, ISO 80601-2-55,
ISO 80601-2-61. The device belongs to protection class I when powered from mains/with in-
ternal power supply (in the absence of connection to the mains) with applied parts of B type
and pulse oxymetry channel of BF type.
• Concerning electromagnetic compatibility (EMC), the device meets the requirements of IEC
60601-1-2. The device is intended for use in the electromagnetic environment specified in
Appendix 3. During operation it is strongly recommended to use of the device in the specified
electromagnetic environment. Use the power cord supplied with the device.
• The room where the device is installed must be equipped with a ground circuit and socket
outlets with ground terminal.
• In the absence of operational grounding circuit at the workplace the device should be operat-
ed from the internal power supply in order to avoid injury of the personnel by electrical shock
in case of emergency breakdown on the enclosure.
• Usage of the device is allowed by personnel older than 18 years old, appropriately trained
and certified, underwent the safety briefing. A prerequisite for admission to operation with the
device is preliminary detailed study of the current manual.
• Do not place the device near curtains. It may hinder the cooling air flow intake into the de-
vice.
• Do not block the fresh gas input, it can cause abnormal patient ventilation.
• Do not use the device in the hyperbaric chambers, it can affect the operation parameters of
the device and have the negative influence on the patient.
• The device is not intended for the administering of the inhaled anesthetics during anesthesia.
• The device is not intended for the administering of the helium or gas mixtures containing he-
lium.

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.

Modification of this device without the permission of the manufacturer is


not allowed!

3-3
3.3 Preparing for operation

3.3 Preparing for operation

After transportation or storage at the low temperatures it is necessary to


sustain the device at room temperature for at least 12 hours in the unpacked
state before its switching on.

3.3.1 Preparing of the device and accessories


• Unpack the device and accessory kit. Make visual inspection and ensure that there are no
external damages and moisture.

The device is supplied non-sterile.

• Before putting into operation clean and disinfect the device and its components in accor-
dance with it. 3.5.

3.3.2 Installation of the electronic unit and the supporting arm


• Install the electronic unit on the table of the cart. Pin in the bottom part of the block should
coincide with the hole on the cart (Figure 2.3, position 9).

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).

Figure 3.2 - Securing the electronic unit on the transport cart

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.

Figure 3.3 – Installation of the supporting arm (circuit holder)

• 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

Figure 3.4 – Self-locking button for changing the segments position

3.3.3 Installation of humidifier


• Install the humidifier into vertical slots of the holder and secure on the bracket (Figure 3.5).

Figure 3.5 – Installation of humidifier


• Fill the humidifier chamber with distilled water and prepare humidifier for operation in accor-
dance with its operating manual supplied.

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.

For the operation of the humidifier use only distilled water.

3.3.4 Assembling of the breathing circuit


• Prepare elements of the breathing circuit, filters, breathing bag (test lung), and water trap of
oximeter channel of metabolism measurement module from the delivery kit. Assemble the
circuit as shown in Figure 3.6.
• Through the inlet port (“Insp” fitting) gas is supplied under breathing pressure through the in-
spiration line to the patient connection port. Through the outlet port (“Exp” fitting) breathing
gas is returned under breathing pressure through the exhalation line from the patient connec-
tion port. Through the EXHAUST port gas is discharged directly into the atmosphere.
• To choose appropriate breathing circuit for certain humidifier use the information in Table
3.1.

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.

Figure 3.7 – Assembly of the breathing circuit without the humidifier

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)

For connection of the masks manufactured by BMC Medical or Intersurgical


with breathing circuit use connector 22F-22F REF1967 Intersurgical Ltd, UK.

Breathing circuit should contain virus-bacterial filter.


Breathing circuit should contain at least one water trap in the expiration
line. Otherwise the manufacturer is not liable for the consequences of the
device malfunctioning.

When using heat-moisture exchange filters it is necessary to consider the


features of their operation (see it. 4.19).

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

Figure 3.12 – Connection of the coaxial breathing circuit

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.

3.3.5 Connecting to the oxygen source


The device can be connected to oxygen sources of various types (main gas supply, cylinders,
oxygen concentrators). For connection to oxygen sources the low pressure oxygen hose comply
with EN ISO 5359 is used. For connection make the follows:
• Connect the filter-regulator from the delivery kit to the “О2” inlet on the rear panel of the elec-
tronic unit using the cap nut with the seal.
• Connect the supplied oxygen hose with NIST connector to the filter-regulator on the rear
panel of device (see Figure 3.13). Thoroughly insert the oxygen hose nut into filter-regulator
threaded inlet and turn as shown on the Figure 3.13.

3-11
3.3 Preparing for operation

Figure 3.13 – Connecting the oxygen hose to the device

Cap nut of the filter-regulator is tightened by hand. It is not allowed to use


tightening key because of possible damage of the O-ring and loss of tight-
ness.

Connection to the oxygen line is allowed only with the regular oxygen filter-
regulator supplied with the device.

During operation of device oxygen of the high concentration is used, so it is


necessary to follow safety rules according to the it. 3.2.

• 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.

Adjusting of filter regulator is prohibited.

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

3.4 Device turning on and off


At the turning on the device and adjustment of the parameters, the patient
shall NOT be connected to the device. Adjustment of parameters shall be
carried out on the test lung supplied.

• 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.

If the "Battery" indicator is lit red (indicating the accumulator or charger


failure), the usage of the ventilator is prohibited, as it does not provide the
ability to work in violation of the mains supply.

• 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.

Figure 3.15– Start testing window of the device

Safe operation of the device is guaranteed by the manufacturer only if start


testing completed without error messages.

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

Figure 3.16 – Message window about rechargable battery malfunction

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

3.5 Cleaning, disinfection and sterilization

3.5.1 Cleaning, disinfection of ventilators external parts and non-sterilized


components

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.

Application of high temperatures and chemical sterilization techniques, in-


volving immersion of external parts and sensors (pulseoximetry and CO2)
into liquid for disinfection is strictly prohibited!

Warranty service of the sensors failed because of incorrect operation is


performed.

Do not expose pins of the sensor (pulseoximetry and CO2) connector to


liquids; it could lead to its failure.

When disinfecting the sensor (pulseoximetry and CO2) cable by wiping do


not apply excessive tensile forces to the cable.

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

Component Procedure Comment

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.

3.5.2 Reprocessing of sterilized components

Reprocessing of certain components shall be carried out after each use as


well as before putting into operation of the ventilator.

The recommendations on reprocessing methods (cleaning, disinfection and sterilization) of ste-


rilized components are stated below. Use only distilled water for solution preparation. The Table
3.4 contains a list of sterilized components and special conditions of reprocessing.
Do not sterilize disposable accessories with corresponding labeling. Utilize disposable accesso-
ries after use in accordance with national standards and your facility’s guidelines for medical
waste disposal

Reusing, dissembling, cleaning, disinfection and sterilization of disposable


accessories could negatively affect functional and safety characteristics of
the ventilator. This may cause serious negative subsequences for medical
personnel and patient.

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.

Тable 3.3. Recommended stages for automated cleaning and disinfection

Stage Temperature Duration

Prerinsing Cold water 3 min


Cleaning 65°C 5 min
Neutralizing Hot water 1 min
Rinsing Cold distilled water 3 min
Thermal disinfection 93 °C 44 min
Drying °C 12 min
Packing
After cleaning and disinfection assemble and put the component into the sterilization pocket.
The sterilization packing should comply with ISO 11607 standard.
Sterilization
• Sterilize the components in hot steam sterilizer at 134°C and 0.21 MPa. Duration of
sterilization is to be not less than 3 minutes and not more than 14 minutes, unless
other condition indicated in Table 3.4.

Table 3.4. Recommended methods for reprocessing of sterilized components

Component Procedure Comment

Expiration valve components

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

Component Procedure Comment

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

4.2 Reserve power supply

4.2.1 Built-in accumulator


In case of sudden shutdown of mains supply the device has the reserve power supply - 2 built-
in accumulators. These are the pressurized, explosion-proof acid rechargeble accumulators that
don’t need any maintenance. Capacity of each accumulator is 7.2 A/h at the 12 V.

In case of sudden shutdown of mains supply the device will automatically


operate from the reserve power supply.
Due to the built-in flow generator, mode of ventilation will not be changed.

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

4.2.2 Features of reserve power supply operation


Table 4.1. Reserve power supply conditions

Light indicator Graphical


Reserve power supply condition symbol on the Alarm priority
“BATTERY”
display
Charge from the mains Green Green No
Fully charged Off Green No
Discharge Yellow Yellow Medium*
Fully discharged Blinking yellow Blinking Red High**
Malfunction Red Blinking Red- High***
* - "No mains voltage".
** - "< 10 min left” or “Accumulator is discharged".
*** - “Accumulator malfunction”

Fully charge built-in accumulator before every using of ventilator with the
connection to the patient.

Presence of the accumulator in the device demands considering features of


its operation (see below).

• 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.

In this situation it is necessary to prepare immediately other means for the


patient ventilation and be ready to use them. When operating with the faulty
accumulator, power supply interruptions can cause switching off the device
and the ventilation termination without any warnings.
Responsibility for negative consequences of operation of the device with
the faulty accumulator lies on medical staff of the medical facility.

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.

Control buttons on the front panel of the device:

• Sound alarm off button – switches off sound alarm for 2 min.

The button is duplicated by the icon on the touch screen.


If at the moment of pressing there are no alarms of medium and/or high priority, the pressing
the button will lead to disabling of sound alarm for 2 minutes, even if during this time there will
be new alarms. The icon will have red-yellow color.
If at the moment of pressing there are alarms of medium and/or high priority, the pressing the
button will lead to disabling of sound alarm for 2 minutes, or before appearing of new alarm. The
icon thus will have blue-white color.

• 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 of menu of additional functions (including nebulizer).

• 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

4.4 Starting window. Beginning of ventilation

4.4.1 Starting window


After turning on of the device on the screen there is the starting window offering a choice of the
new patient or continuation of the ventilation with parameters of the previous patient:

Figure 4.1 – Starting window of the ventilator

* - 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

4.4.3 Automatic calculation of initial ventilation parameters


According to the entered data in starting window (height and gender of the patient) the device
ventilation automatically calculated starting parameters for all provided modes.
MV for adults and children differs and is calculated in liters per kg of ideal weight (IBW):
• For the adult patients MV = 0.1 liter per kg IBW,
• For the children with weight more than 30 kg MV = 0.1 liter per kg IBW,
• For the children with weight up to 5 kg inclusive MV = 0.3 liter per kg IBW,
• For the children with weight from 5 to 30 kg MV = (–0.008×IBW+0.34) × IBW.
The above described calculations are visually presented on graphics.

Figure 4.3 – Automatic MV calculation for adults and children

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

Parameter Value Notice


RB MV/Vt calculated values of MV, Vt
15 cmH2O children with IBW from 3 to 30 kg
15 cmH2O adults with IBW from 30 to 89 kg
Pi 18 cmH2O adults with IBW from 90 to 99 kg
20 cmH2O adults with IBW above 100 kg
previous value in BiStep, APRV modes
1:2 adults (except APRV)
I:E 1:2.5 children (except APRV)
1:2 in APRV and APNEA modes
FiO2 40 %
PEEP 5 cmH2O
15 s children
Tapnea
20 s adults
Pramp 100 cmH2O/s patients over 50 kg
50 смH2O/s patients up to 50 kg
TrigWnd 100 %
2 lpm pediatric mode sensitivity of the trigger
Ftrig
3 lpm adult mode
Pmax 35 cmH2O children
40 cmH2O adults
%MV 100 %
Plow BiS- 5 cmH2O
tep
Phigh BiS- 7 cmH2O
tep
Tlow BiS- 5s
tep
Thigh BiS- 7s
tep

4.4.4 Initial alarm settings


Alarm thresholds MV for the new patient are set automatically at the start of ventilation: MV max
= 1.5 MV, MV min = 0.7 MV.
Default value of the bottom alarm threshold Vt min = 4.4 ml/kg IBW for all modes. Default value
of the top alarm threshold Vt max - 16 ml/kg of IBW.
During operation at regulation of parameters, limits of alarms do not change. If %MV changes,
the bottom threshold 0.7 MV from 100%MV always remains constant, also as well as the top
threshold of 1.5 MV at setting of %MV in the range from 25 to 100 %. At the setting %MV more
than 100 %, the top alarm threshold is increasing on the corresponding value. For example, if
%MV is set to 200 %, the top alarm threshold is set to 250 %, if %MV is set to 220 % - the alarm
threshold is set to 270 %. If adaptation is enabled, the top alarm threshold is set to 250%MV.

4.4.5 Calibration procedure before the beginning of operation


In some cases before the beginning of operation it is necessary to carry out the calibration.

4-9
4.4 Starting window. Beginning of ventilation

Absence of calibrations can cause the decrease of measurement accuracy


of some parameters of the device.

• At the replacement of a breathing circuit (application of circuit of other type or manufacturer)


obligatorily carry out the calibration of the breathing circuit: [Menu] → [Service menu] →
[Calibration] → [Breathing circuit calibration].
• At conducting of breathing circuit calibration compliance and resistance of the current circuit
is defined and then used for more exact calculation of inspiration pressure and target tidal
volume. This is especially important for ventilation of children. When using one type of
breathing circuit without autoclaving, the circuit calibration is generally not required.
Calibration procedure of the breathing circuit is described in it.4.16.5.
• After disassembling (disinfection) or replacement of the removable part of the expiration
valve it is recommended to carry out exhalation flow sensor calibration:
[Menu] → [Service menu] → [Calibration] → [CIVL] → [Exp. flow sens. calibr.]
Calibration provides more precision measurement of tidal volume VT and positive end-expiratory
pressure PEEP. Calibration procedure is described in it. 4.16.3

4-10
4.5 Main window

4.5 Main window


3 4 5 6 7 10
8 9

2
11

12

15

14
14
13

16
Figure 4.4 - Main window

1 Monitoring parame- Selection of parameters displayed in the rectangle is made in


ters indication area [Menu] → [Display settings] → [Choose measured par. blocks].
(fields 1-3) Some indication rectangles at the same time are also touch-
sensitive buttons allowing to adjust the alarm thresholds.
2 Symbol of patient’s Graphical symbol of head is highlighted by the bright white color
spontaneous at the moment of patient’s breathing attempt.
breaths
3 Set ventilation mode At the same time it is a touch button opening the "Ventilation
modes" submenu window.
4 Accumulator condi- See it. 4.2.
tion symbol
5 Line of icons of ad- Icons are used for the quick access to additional features and
ditional functions displaying of their status. Depending on the completeness of the
device the following icons can be displayed:

Icon Additional function Notice

Sound alarm off Up to 120 s

Oxygenation it. 4.11.2

Suction it. 4.11.3

Standby mode it. 4.11.4

4-11
4.5 Main window

Alveolar recruitment maneuver it. 4.11.1

Leak compensation it. 4.11.5

Manual breath (manual


it. 4.11.6
ventilation)

"Freezing"/analysis of graphs it. 4.11.8

Screen lock it. 4.11.7

Enabling of the function is accompanied with a change of icon’s


color and with the indicator “on” above it. If the function is active
within a certain time, timer of operation of the function is dis-
played in the indicator field. If clicking on the icon does not result
in its activation, this means that the necessary conditions for
enabling are not fulfilled. These conditions are described in the
relevant sections for each function. Some icons in the active
mode have a red color of frame and letters, and yellow back-
ground. These icons correspond to the functions that require high
degree of attention.
6 Area (section) of in- • high priority alarm messages (in the main mode);
dication of date/ • name of menu window (in the menu mode);
time or messages
• warning about the impossibility of changing the parameter (in
the mode of parameter setting).
7 Area (section) of in- Changing of the mode of graphs displaying is made in [Menu] →
dication of graphs, [Display settings] → [Graphs]. Changing of the mode of trends
menu windows,
displaying is made in [Menu] → [Trends].
trends (depending
on the selected
mode)
8 Touch button Saving the current state of the screen to a file on removable
"screenshot" USB-Flash connected to the USB-port. Saving is made to the file
scr0000.bmp (number changes with increasing number of file) in
the SCREEN directory.
During screen saving that can take up to 40
seconds, the operation with the interface
(touchscreen, buttons and encoder) is
blocked, and the content of the screen is not
updated. This condition is indicated by the

symbol . Ventilation is not interrupted, and


the rest of the algorithms of the device are
carried out normally.
9 Touch button of Day/night mode (see it. 4.11.9).
changing brightness
10 Patient parameters At the same time it is a touch button that opens the "Patient
parameters" submenu.
11 Indicator of "Patient
height" parameter

4-12
4.5 Main window

12 Field of indication of Selection of parameters displayed in the rectangle is made in


monitoring parame- [Menu] → [Display settings] → [Choose measured par. blocks].
ters (fields 4-8) These rectangles are also touch-sensitive buttons, clicking on
them user can adjust the alarm thresholds.
13 Field of indication of It consists of the constantly displayed bottom row (8 parameters)
the set ventilation and of top row that appears in the setting mode. Each ventilation
parameters mode corresponds to a specific set of defined parameters, for
details see it. 4.7. The window of each parameter is the touch
button.
14 Icon of enable/ Respiratory monitoring - RESP2, RESP3 (see it. 4.18), window of
disable windows of metabolic parameters see it. 5.5.
extended respirato-
ry monitoring and
window of metabolic
parameters
15 Area (section) of Up to 6 lines
alarm list indication
16 Symbol “SP” - spon- There is separate indication for spontaneous and mandatory
taneous
breaths. Symbol displays on volume expiratory field.

4-13
4.6 Main menu

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.

Table 4.3. Main menu parameters

Parameter Function Description

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

4.7 Setting of ventilation modes and parameters

4.7.1 Ventilation mode selection

Selection of ventilation mode is made by encoder or touch buttons (menu rows).

Table 4.4. Ventilation modes menu

Parameter Function Description


Continuous mandatory ventilation with the controlled
CMV/VCV Appendix 1.1
volume of inspiration
Continuous mandatory ventilation with the controlled
CMV/PCV Appendix 1.2
pressure of inspiration

SIMV/PC Synchronized intermittent mandatory ventilation with flow


trigger or pressure trigger with pressure (volume) control Appendix 1.3
(SIMV/VC) with pressure support of spontaneous breaths (PS)

Synchronized intermittent mandatory ventilation with flow


SIMV/DC trigger or pressure trigger with double control with pressure Appendix 1.3
support of spontaneous breaths (PS)
Spontaneous breathing with continuous positive airway
CPAP+PS pressure with pressure support of spontaneous breaths Appendix 1.4
(PS)
Spontaneous breathing with two levels of continuous
BiSTEP positive airway pressure with pressure support of Appendix 1.6
spontaneous breaths (PS)
APRV Airway pressure release ventilation Appendix 1.8
NIV Non-invasive ventilation of lungs Appendix 1.7
Mandatory ventilation with pressure control and
guaranteed delivery of target respiratory volume at
PCV-VG Appendix 1.9
minimum possible pressure with pressure control, with
pressure support of spontaneous breaths (PS)
iSV Intellectual support ventilation Appendix 1.10

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.

4.7.2 Changing of parameters. Conflict of parameters


Changing of ventilation parameters:
• There are up to 8 windows of parameters in the bottom row and additional windows in the top
row (if necessary) for setting ventilation parameters. The top row is only available in “Edit”
mode. In some modes of ventilation only a part of windows can be used. In this case the
name of the parameter in this window is displayed in gray color of low contrast or is not
displayed.
• Selection of ventilation parameter for its setting is made by pressing the window (graphic
touch button) of the appropriate parameter. Window of the set parameter changes
background color to blue one.
• Rotate or press the encoder to change or confirm changing of parameter.
• While parameter is adjusted, new value of parameter is not applied by ventilator. The device
detects (but not apply) new parameter value only after its confirmation (pressing the touch
button or encoder). Background of parameter window changes its color to grey (white).
• At the each step of parameter changes, all related parameters are recalculated and instantly
change on the screen. At recalculation there is a check for conflict settings.
• If at parameter changes, any related parameters exceed their limits, they are highlighted with
red color. If user tries to apply incorrect parameters, "Apply" button is blocked until the
conflict is resolved.
• Parameter comes into effect by pressing the encoder when the cursor is on the "Apply"
button, or by pressing "Apply" touch button.
• If there was no confirmation of changes, the ventilator exits parameter setting mode in 30
seconds and returns to the previous parameter value.
• View of the ventilation parameters row for the each mode is shown in it. 4.7.3.
• Description of the ventilation parameters is in the it. 4.7.4.

4-16
4.7 Setting of ventilation modes and parameters

Parameter setting in the apnea mode:


• At the apnea ventilation mode with volume control respiratory rate (RB) and tidal volume
(Vapnea) are set automatically but can be corrected by the user.
• At the apnea ventilation mode with pressure control respiratory rate (RB) is set automatically
by the same rules depending on the patient’s weight. The target inspiratory pressure in the
apnea ventilation mode with pressure control (Piapnea) is set by user.
• In the NIV mode only apnea ventilation with pressure control is available.

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

4.7.3 View of parameter setting line in the different ventilation modes


Parameter setting line in the CMV/VCV mode
Windows of parameters
CMV/VСV
1 2 3 4 5 6 7 8
Top line Tplat TrigWnd
Bottom line FiO2 Pmax RB PEEP FormFlow VT Tinsp Ptrig

Parameter setting line in the CMV/PCV mode


Windows of parameters
CMV/PСV
1 2 3 4 5 6 7 8
Top line TrigWnd
Bottom line FiO2 Pmax RB PEEP Pramp Pi Tinsp Ptrig

Parameter setting line in the SIMV/PC mode


Windows of parameters
SIMV/PС
1 2 3 4 5 6 7 8
Top line TrigWnd Pramp
Bottom line FiO2 Pmax RB PEEP PS Pi Tinsp Ptrig

Parameter setting line in the SIMV/VC mode


Windows of parameters
SIMV/VС
1 2 3 4 5 6 7 8
Top line Pramp Tplat FormFlow TrigWnd
Bottom line FiO2 Pmax RB PEEP PS VT Tinsp Ptrig

Parameter setting line in the SIMV/DC mode


Windows of parameters
SIMV/DС
1 2 3 4 5 6 7 8
Top line Pramp TrigWnd
Bottom line FiO2 Pmax RB PEEP PS VT Tinsp Ptrig

Parameter setting line in the CPAP+PS mode


Windows of parameters
CPAP+PS
1 2 3 4 5 6 7 8
Top line Fsupp
Bottom line FiO2 Pmax PS PEEP Pramp ETC Tapnea Ptrig

Parameter setting line in the BiSTEP mode


Windows of parameters
BiSTEP
1 2 3 4 5 6 7 8
Bottom line FiO2 Phigh Plow PS Pramp Thigh Tlow Ptrig

4-18
4.7 Setting of ventilation modes and parameters

Parameter setting line in the APRV mode


Windows of parameters
APRV
1 2 3 4 5 6 7 8
Bottom line FiO2 Phigh Plow PS Pramp Thigh Tlow Ftrig

Parameter setting line in the NIV mode


Windows of parameters
NIV
1 2 3 4 5 6 7 8
Bottom line FiO2 PEEP PS Facc Piapnea RBapnea Tapnea Ptrig

Parameter setting line in the PCV-VG mode


Windows of parameters
PCV-VG
1 2 3 4 5 6 7 8
Top line TrigWnd
Bottom line FiO2 Pmax RB PEEP Pramp VT Tinsp Ptrig

Parameter setting line in the iSV mode


Windows of parameters
iSV
1 2 3 4 5 6 7 8
Top line Pmin
Bottom line FiO2 Plimit PEEP %MV Ftrig Pramp ETS Adapt.MV

4.7.4 Description of ventilation parameters


This section describes the ventilation parameters available for control in the lower lines of the
main screen. Some parameters common for the all ventilation modes are described in it. 4.8
(menu of the general parameters).
• FiO2 – fractional concentration of inspired oxygen. The device automatically maintains the
set oxygen concentration. The measured value of the oxygen concentration is displayed in
the field of monitored parameters.
• Pmax – maximum acceptable inspiratory pressure. Pmax parameter is used in all modes to
limit the pressure in the patient breathing circuit and to prevent barotrauma. If the pressure in
the patient breathing circuit for some reason has become equal to or higher than Pmax, the
device immediately opens the exhaust valve and begins expiration. At any ratio of
parameters the device ensures that Pmax greater or equal to (Pi + PEEP + 5 cmH2O) or (PS
+ PEEP + 5 cmH2O), or "APPLY" touch button for confirmation of changes will be blocked.
Pmax control limit is determined by the selected patient type (adult/child) and for some
ventilation modes can be set in [Menu] → [Ventilation parameters] → [Pmax limit].
• RB – respiratory rate (CMV/VCV, CMV/PCV, PCV-VG modes). At changes of RB parameter,
parameters associated with it (MV, I:E, Texp) recalculate automatically. Tidal volume VT is
not changed; respectively the minute volume MV is changed proportionally to the frequency
change. inspiratory time Tinsp remains unchanged. Changing of frequency and period of
respiratory cycle is made due to the change of expiratory time and I:E parameter (inspiration
to expiration ratio).
• RB – respiratory rate, frequency of mandatory breaths (SIMV/VC, SIMV/PC modes). It is
regulated similarly to RB in automatic mandatory ventilation modes. The only difference is

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

Figure 4.5 – Pramp adjustment

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.

P(t) P(t) P(t)

Too low value of Optimal value of Large value of Pramp


Pramp Pramp

Figure 4.6 – Influence of Pramp to the inspiration pressure waveform

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

4.8 Menu of general ventilation parameters setting

4.8.1 Description of general ventilation parameters


To enter the menu press:

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).

Table 4.5 - Parameters of ventilation modes menu:

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

4.8.2 Menu of apnea parameters


Menu of apnea parameters is available when the device switches on (or ventilation mode is
changed) – for ventilation modes that support spontaneous breathing, and also through the
main menu:

Table 4.6. Parameters of apnea ventilation


Designation of
Description of parameter Values
parameter
Control Сontrolled ventilation with volume or pressure control by volume,
by pressure
Piapnea Inspiratory pressure above apnea PEEP level in the
apnea mode:
- child mode 10 - 25 cmH2O
- adult mode 10 - 80 cmH2O
Vapnea Tidal volume in the apnea mode:
- child mode 10 - 400 ml
- adult mode 200 - 2000 ml
RBapnea Respiratory rate in the apnea mode:
- child mode 15 - 60 1/min
- adult mode 8 - 60 1/min
Tapnea Time of transition to the apnea mode after detection
of apnea:
- child mode 10 - 20 s
- adult mode 10 - 60 s

4-24
4.8 Menu of general ventilation parameters setting

4.8.3 Menu of iSV mode parameters

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).

4.8.4 Menu of Pmax, Tinsp limits

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

4.9 Setting of the type of inspiration trigger


The ventilator has two types of inspiration triggers - flow and pressure.

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).

Do not set high trigger sensitivity of 1 - 2 lpm (1 cmH2O) without necessity. It


can cause false triggering because of different kinds of noise of auto trigger-
ing.

4-26
4.10 Automatic calibration of the oxygen sensor

4.10 Automatic calibration of the oxygen sensor


The "Automatic calibration of the oxygen sensor" fuction provides the ability to accurately
measure of FiO2 at the changing of the external conditions: temperature, pressure or aging of
oxygen sensors.
Auto calibration of oxygen sensor is switched on in the main menu:

Enter the menu:

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

4.11 Additional functions


Additional features of the ventilator include:
• Alveolar recruitment maneuver;
• Oxygenation;
• Suction;
• Standby mode;
• Leak compensation;
• Manual breath (manual ventilation);
• Screen lock;
• "Freezing" / analysis of graphs;
• Display brightness control (night or day mode).
Selection of the desired additional function is performed by the corresponding icon on the main
screen of the device (Figure 4.4, position 5).
Enabling of some additional functions is available through the submenu of additional functions
(entrance through the main menu or with the button on the front panel of the ventilator):

4.11.1 Alveolar recruitment maneuver


Current procedure is active only in CMV/PCV and CMV/VCV modes, with the type of patient
"Adult”
Activation of the function is available through [Menu] → [Addtitional functions] → [Alveolar re-

cruitment maneuver] or icon on the main screen.


Enabling of function is impossible in the following cases:
• If the type of patient «Child»;
• if set PEEP exceeds 22 cmH2O;
• at non-compliance with the condition Pmax – PEEP – Pi – 5 ≥ 3 cmH2O;
• at active ventilation modes other than CMV/VCV, CMV/PCV;
• if the "Sigh", "Leak compensation" or "Suction" function is enabled.
4-28
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

Alveoli inflating phase

∆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

min] or icon on the main screen.

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

4.11.4 Standby mode


Activation of the function is available through [Menu] → [Additional functions] → [Standby mode]

or through the icon on the main screen.

Enabling of this mode leads to:


• Stopping the ventilation;
• Blocking of all alarms;
• Blocking of the operation with the interface except encoder, button "Start" and “Vent.param”;
• Reset (cancellation) of all selected additional functions.

To resume the ventilation press the encoder or "Start" button.


To edit or save ventilation parameters press the button "Vent. param".
At the clicking on this button "Parameters" menu appears:

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.

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4.11 Additional functions

4.11.5 Leak compensation


This function is used for ventilation in the conditions when the tightness of the breathing circuit
can not be ensured. However, the capabilities of the device to compensate the leakage are not
unlimited and operator should take measures to decrease it as much as possible.
In presence of leakage it is recommended to set one of the pressure-controlled modes. In mod-
es with volume control or double control the accuracy of tidal volume is lower.
Leakage compensation is provided in all modes of ventilation.
In BiSTEP, ARPV, NIV, CPAP+PS modes leakage compensation is provided automatically by
pressure control. As the ventlator tries to achieve the inspiratory pressure set by physician, the
measured expiratory volume reflects the tidal volume received by the patient.
In other modes activation of the leakage compensation is available through [Menu] → [Addition-

al functions] → [Leak compensation] or through the icon on the main screen.

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.

4.11.6 Manual breath (manual ventilation)


The "Manual breath" function (single mandatory breath) is intended to accelerate the start of
ventilation at the suction, especially in conditions of spontaneous breathing, for lung recruitment
maneuvers, for diagnostic (X-rays) and treatment (synchronization with aerosol administration
of dose of medicines) procedures.
View of manual breath activation button:
Button is located in the row of icons. View of inactive and active button of activation of the ma-
nual breath is shown below.
Button
holding time

Running the function:


The function is running at pressing the appropriate button by the user. If the function is initia-
lized by the operator in the inspiratory phase - the phase is extended until the button is re-
leased, but not more than 15 seconds.
If the function is initialized by the operator in the expiratory phase - expiration is interrupted, ex-
traordinary breath with the current settings is started. Inspiraiton lasts until operator releases the
button, but not more than 15 seconds, or at the end of the current criterion of inspiration, if the
button is released before.
If the pressing is in forbidden phase of the expiration - activation of an extraordinary inspiration
begins at the end of the forbidden expiratory phase. Additionally the inspiration is delayed, if
pressing coincided with forbidden phases in BiSTEP or APRV mode.
If the button is pressed more than 15 seconds, then at the end of 15 seconds the inspiration is
interrupted and ventilation with the current settings begins. Pressing the button is ignored. To
reactivate the function, firstly release the button.
Timer shows the holding time of the button. Through 15 seconds the counter stops. When user
releases the button, the counter disappears.
If the nebulizer is active, at clicking "Manual breath" button it begins operation, and continues
during the set by physician inspiratory time or until the beginning of the formation of the plateau.

Running of the manual breath in different modes:


In CMV, PCV-VG modes manual breath is performed as a hardware breath with the current pa-
rameters. Inspiratory volume should correspond to the set VT. If the button is held longer than
Tinsp, in modes with volume control flow must be stopped at the moment of Tinsp.
In the PCV-VG mode (similar to SIMV/DC), if the previous PCV breath is incorrect, manual
breath will be performed as a test one.
In the SIMV mode manual breath is performed as hardware breath with the current parameters.
Inspiratory volume in the volumetric modes should correspond to the set VT. If the button is held
longer than Tinsp, flow must be stopped at the moment of Tinsp.
In the CPAP+PS and NIV modes manual breath is performed as hardware breath with pressure
control with pressure Pi = PS with the current rate of pressure rise. If the button is released be-

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.

Running of "Manual breath" function together with compliance measurement maneveur


and AutoPEEP
If at the inspiratory phase procedure of compliance plateau formation was performed and dura-
tion of inspiratory phase was more than (set inspiratory time + maximum compliance plateau
duration), measurement of compliance and resistance will be not performed.
If manual breath is activated at the moment of formation of AutoPEEP measurement procedure,
procedure will be immediately stopped, AutoPEEP will be not measured and previously meas-
ured AutoPEEP value will be displayed.
AutoPEEP measurement procedure will not be called if manual breath is initiated.

Manual ventilation
If necessary the physician can perform manual breaths with the desired frequency, thereby per-
forming the manual ventilation.

4.11.7 Screen lock


Screen lock function is used for protection against inadvertent changes of parameters. Enabling

is performed via icon on the main screen. At the same time:


• The whole touch screen is locked, in the bottom part of the screen yellow message "Touch
screen is locked" is displayed.
• Data output continues as usual. Alarms are not blocked.
• Encoder and button of temporarily disabling of the audible alarm is not blocked.
Press the encoder to unlock the screen. At pressing the menu "Unlock touch screen? Yes. No."
is shown. If user selects "Yes" line by encoder handle the lock is released. If user selects the
line "No" lock retains.

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4.11 Additional functions

4.11.8 "Freezing" / analysis of graphs


The "freezing" of graphic curves is used for detailed analysis of the respiratory cycle and view-
ing via the encoder of instantaneous values of the curves. The function is active when the set
number of output graphs is from 1 to 3.

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.

Figure 4.8 – Pressed button “Freezing”

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).

4.11.9 Display brightness control


The function allows to change the display brightness separately for the day and night operation

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).

4.12.1 Graph setting menu


To enter the menu press:

Selection of the quantity and type of graphs


• Set "Graph number" parameter (from 1 to 4).
• Set the "Graph speed" parameter (1, 2, 4). Default value of speed for adult type of patient is
1, for pediatric one is 2.
• Select function for each graph from the following list:
Paw Airway pressure waveform
Flow Flow waveform
Vol Volume waveform
Loop Loop curves: volume/flow, volume/pressure, flow/pressure,
volume/auxiliary external pressure
PCO2, mmHg Capnogram [mmHg]
PCO2, % Capnogram [%]
РO2, % Oxigram [%] (for metabolism measurement)
SpO2 Photopletismogram (PPG)
iSV graph Graph of iSV mode
Рaux Auxiliary external pressure waveform
VCO2 Volume capnography waveform
Note: Selection of the "Loop" graph is possible when the number of graphs is 1 or 4. Selection
of iSV mode graph is possible when the number of graphs is 2 or 3.

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.

Enable/disable filling of graphs


The function allows to select the view of the output curves in the form of outlines or filled
graphs. Filled graphs have better contrast. Inspiratory phase of the respiratory cycle is hig-
hlighted with blue for the hardware and white for spontaneous breaths. In addition the start of
spontaneous inspiration is shown with crimson vertical bar.
To activate the function set "Filled graphs" in the "On" position in the submenu "Graphs".

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).

Figure 4.9 – Pressure in the patient airways (Paw)

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.

Displaying of spirometry loops


Spirometry loops are displayed in the mode of 1 and 4 graphs.
At selection of spirometric loop and displaying of 1 graph, two interactive buttons TYPE and
REF are displayed. At the activation of TYPE button, menu of selection of spirometric curve
type appears on the screen:
• volume/flow V-F,
• volume/pressure V-P,
• flow/pressure F-P,
• vol/pressure V-Paux (option).
Press the appropriate line to select the desired loop type. Press the TYPE button again to hide
the selection of spirometry loop type.
Simultaneously with the current spirometric curve, previous or reference loop is displayed on
the screen in gray.
Setting of the support (reference) loop is performed by pressing the REF button. At pressing
REF:

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.

Displaying of iSV graph


iSV graph allows to estimate the optimal choice of parameters of ventilation by algorithms of
current ventilation mode. The iSV graph displays the respiratory rate and tidal volume scales.
iSV graph shows:
• limits of safe ventilation by RB and Vt, top and bottom values (in graphical and numerical
view);
• target values of RB and Vt (in graphical and numerical view);
• real values of RB and Vt (in graphical and numerical view);
• target minute ventilation values in % and ml/min;
• adaptation minute ventilation values in % and ml/min;
• values of the current inspiratory pressure for hardware breaths;
• values of the current support pressure for spontaneous breaths.
Example of realization of graph:

Inspiraiton volume Vtmax can be limited in [Menu] → [Ventilation parameters] → [iSV


parameters].

Changing of the graph indication mode does not effect on the current lung
ventilation mode.
4-38
4.12 Display settings menu

4.12.2 Menu of settings of measuring parameter blocks

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

4.13 Menu of view of trends and alarm log

"Trend view" parameter


At the selection of "Trend view" parameter the device displays the trend window:

Figure 4.10 - Window of trends


In the main part of the screen from 1 to 4 trend graphs are displayed (according to the choice of
user). In the top part of the screen 5 additional fixed trends associated with graphs are
displayed, they are:
• PIP (peak inspiratory pressure);
• PEEP (positive end-expiratory pressure);
4-40
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.

Trend review is carried out without interrupting of ventilation. Measurement


and indication of the ventilation parameters are also saved.

"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

Table 4.8. List of parameters displayed in the form of trends


№ Parameter Name Meas.units
1 PIP Peak inspiratory pressure cmH2O
2 PEEP Positive end-expiratory pressure cmH2O
3 Pm Mean pressure for the respiratory cycle cmH2O
4 MV Minute volume lpm
5 MVexp Expiratory minute volume lpm
6 MVspont Minute volume of spontaneous breaths lpm
7 Vexp Expiratory volume ml
8 Vinsp Inspiratory volume ml
9 Tinsp Inspiratory time s
1
10 RB Respiratory rate /min
11 Leak Leakage flow from the breathing circuit lpm
12 Cst Static compliance ml/cmH2O
13 Rst Static resistance cmH2O⋅s/l
Partial pressure of CO2 in the exhaled mixture (Et-
14 CO2 mmHg
CO2)
15 SpO2 Оxygen saturation of arterial blood hemoglobin %
1
16 PR Pulse rate /min
17 AutoPEEP Residual pressure level in lungs cmH2O
18 RCexp (t) Expiratory time constant s
19 SI Stress index cmH2O
20 Wvent Work of the ventilator breathing J/l
21 Wspont Work of the patient breathing J/l
22 PEEPtot True pressure level in lungs at the end of expiration cmH2O
23 FiO2 Fractional concentration of inspired oxygen %
24 Сcirc Compliance of the breathing circuit ml/cmH2O
25 Rcirc Resistance of the breathing circuit cmH2O⋅s/l
26 ExpEndFlow Flow at the end of expiration lpm
1
27 fspont Frequency of spontaneous breaths /min
28 RSBI Rapid shallow breathing index
29 I:E Inspiratory:expiratory ratio
30 Acc.charge Residual accumulator capacity %
31 VO2 Oxygen consumption ml/min
32 VCO2 Elimination of СО2 ml/min
33 RQ Respiratiory quotient rel. units
34 REE Resting energy expenditure kcal/day
"Clear trends" parameter allows the user to delete the previously stored in trends data. To
activate this action enter the system password. To exit without clearing the trend press 4 times

the encoder or press the "Menu" button.

4-42
4.13 Menu of view of trends and alarm log

"Alarm log" parameter


At the selection of the "Alarm log" device allows to view the list of alarms and events (turning the
device on, switching between ventilation modes, diagnostic messages, used functions) with the
name and priority of the alarm (messages are painted in different colors depending on their
priority), the date and time of their occurrence.

Figure 4.11 – 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

4.14 Alarm settings menu


Enter the window through the main menu of ventilator (see it. 4.6).

Figure 4.9. Alarm threshold parameters


Line of the
Designation, description of parameters Possible values Default value
menu
FiO2 sensor – display of FiO2 readings
on/off on
(dashes «---» are displayed in the «off» position)
FiO2 FiO2 alarms – enable/disable FiO2 alarms on/off on
О2 deviation – level deviation of measured 1…50 %,
5%
concentration from set that triggers the alarm. off
Low oxygen pressure alarm threshold in the input
О2 pressure line. The recommended values are 1.0, 1.5 atm 0.0, 0.5, 1.0, 1.5
1.0 atm
(min) (kgf/cm2). Set "0.0" value only in case of atm
ventilation from low pressure О2 source or air.
Low inspiratory pressure alarm threshold. "0"
Low PIP 0…20 cmH2O 0 cmH2O
value means disabled alarm.
Low PEEP alarm threshold. "0" value means
Low PEEP 0…10 cmH2O 0 cmH2O
disabled alarm.
MV_max – top alarm threshold of minute breathing
MV_min…60 lpm 12 lpm
volume.
MV
MV_min – bottom alarm threshold of minute 0…MV_max
2 lpm
breathing volume. lpm
Vexp_max – top alarm threshold of expiratory Vexp_min… 6000
6000 ml
volume. ml
Vexp
Vexp_min – bottom alarm threshold of expiratory 0 … Vexp_max
0 ml
volume. ml
RB_min…120
RB_max – top alarm threshold of respiratory rate. 1 40 1/min
/min
RB
RB_min – bottom alarm threshold of respiratory 1… RB_max
1 8 1/min
rate. /min
EtCO2_max – top alarm threshold of СО2 partial EtCO2_min…100
40
pressure in exhaled air [mm Hg]. mmHg
Capnometer
EtCO2_min – bottom alarm threshold of СО2 15… EtCO2_max
15
partial pressure in exhaled air [mm Hg]. mmHg
4-44
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

4.15 Volume settings menu


Enter the menu through the main window of the device (see it.4.6):

Designation Description of parameters Values


Alarm sound vol Volume level of sound alarm 30…100 %
Beeper sound vol Volume level of signal of spontaneous breaths
5…100 %
(BEEP signal)

For the purposes of patient’s safety user can not disable of set alarm
volume less than 30 %.

4-46
4.16 Service menu

4.16 Service menu


The service menu includes functions of full internal testing (FIT) and calibration of various
systems of the device. The entrance in the service menu is made through the main menu of the
device (see it. 4.6). This menu is intended for the service personnel of medical equipment in
medical facilities, and the staff of the service centers.

4.16.1 Function of service menu parameters


• Versions of modules parameter allows to see software version numbers of the units and
modules which are present at the device, their serial numbers (CIVL – ventilation controller,
CIND – display controller, PU – power unit, GM – gas mixer circuit, PR.CONV. – protocol
converter circuit, Oximet. – sidestream oximeter (metabolism measurement module),
PR.CONV. – protocol converter, SpO2 – pulse oximetry module, CMS – network card and
PMM – pressure measurement module).

• 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.

Table 4.10. CIVL calibration parameters:


Parameter Function Description
FiO2 sensor calibration Call of procedure of the oxygen sensor calibration it.4.16.2
FiO2 sensor replacement Call of procedure of the oxygen sensor replacement it.4.16.2
Exp. flow sens. calibr. Call of procedure of expiratory flow sensor it.4.16.3

4-48
4.16 Service menu

Parameter Function Description


calibration
Selection of conditions (temperature, humidity,
Insp. conditions pressure) for the correction of inspiratory flow: ATP, it.4.16.4
ATPS, ATPD, BTPS
Selection of conditions (temperature, humidity,
Exp. conditions pressure) for the correction of expiratory flow: ATP, it.4.16.4
ATPS, ATPD, BTPS
Selection of the minimum and maximum available
Thresholds voltage on the new oxygen sensor (system -
password is required).

 CIND parameter is used to enter the calibration menu of the indication controller:

o Interface language allows to select language of the interface.


o Touch screen calibration parameter is used to align the coordinates of graphical
display control buttons with areas on the touch screen. In the touch screen
calibration mode it is necessary to perform consistently all the instructions on the
display.
o The Day brightness and Night brightness parameters are used for changing of
the display brightness during the day (05.00 - 00.00) and night (00.00 - 05.00) time
in the range 50 - 100 % and 30 - 100 %, respectively. Default values are 100 % for
day brightness and 60 % for night brightness.
 Breathing circuit calibration parameter is recommended after changing of the breathing
circuit type. Before starting of the calibration select the type of the circuit (adult or
child/coax.), connect the breathing circuit with filters to the device, release or close up the
patient tee depending on the instructions on the display.

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

4.16.2 Calibration of FiO2 sensor, O2 sensor of metabolism measurement module

Calibration of FiO2 sensor


Calibration of the oxygen sensor measuring the concentration in the inspiratory gas (FiO2) is
conducted in the following cases:
• During maintenance.
• After replacement of the FiO2 sensor.
• If the message "Check or replace the oxygen sensor" appears according to the results of
the automatic performance control and calibration of the FiO2 sensor (see it. 4.10), or at the
other deviations in the FiO2 measurement, particularly if concentration measurement error
exceeds 2 % during air ventilation.
FiO2 sensor of electrochemical type is applied in the device. Its lifetime depends on the time
spent in oxygen environment and on oxygen concentration. At medium operation parameters
lifetime of the FiO2 sensor should be at least 1.5 years. Calibration of the FiO2 sensor usually is
important in the final phase of the life cycle of the sensor in order to prolong its lifetime and en-
sure the required accuracy characteristics.
To calibrate FiO2 sensor:
• disconnect the device from the patient;
• enter the [Menu] → [Service menu] → [Calibration] → [CIVL] → [FiO2 sensor calibration];
• run the calibration by pressing the encoder (sensor calibration takes about 1 minute).

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

No Message Alarm condition Operator’s actions


Calibration successfully Successful completion of Continue to work with the device
1
completed calibration
Calibration successfully Successful completion of Replace the oxygen sensor as soon
completed, it is calibration, the oxygen as possible and perform the oxygen
2 recommended to replace sensor lifetime is coming to sensor replacement procedure from
oxygen sensor the end the menu [Menu] → [Service menu]
→ [Calibration] → [CIVL]
Could not set CIVL to oxygen Ventilation controller don’t Contact the customer service
3 sensor replacement mode respond to calibration
request
No information about Gas mixer malfunction Contact the customer service
4 atmospheric pressure or
information is incorrect
The oxygen sensor is missing Low voltage from the Install another oxygen sensor. If after
or malfunctioning oxygen sensor oxygen sensor replacement message
5 appears again during oxygen sensor
replacement procedure, please
contact the customer service.
Calibration cancelled Calibration is cancelled by Continue to work with the device
6
the user
Malfunction of oxy measuring Oxygen measuring channel Contact the customer service
7 channel in CIVL in ventilation controller is
faulty
Coefficients writing error Malfunction in the ventilation Contact the customer service
8
controller
Oxygen sensor calibration No messages from Contact the customer service
9 time out ventilation controller about
calibration results

4-52
4.16 Service menu

Calibration of O2 sensor of metabolism measurement module


If the device has metabolism measurement module, the fast oxygen sensor calibration is re-
quired. This sensor measures FiO2 in Metabolism window and shows the difference of the oxy-
gen concentration at the inhalation and exhalation FiO2 - EtO2:
• enter [Menu] → [Service menu] → [Calibration] → [CAPNO] → [Calorimeter O2 sensor ca-
libr.], at that the device displays a brief calibration instruction;
• run the calibration by pressing the encoder (calibration lasts about 10 - 15 sec).
In the case of successful calibration the message "Calibration successfully completed” will be
displayed. The device is ready for operation.
At unsuccessful calibration sensor replacement or device repair is required.

4.16.3 Expiratory flow sensor calibration


Make the procedure every time after replacement of the removable part of expiration valve.
For calling of the procedure select parameter: [Menu] → [Service menu] → [Calibration] →
[CIVL] → [Exp.flow sens. calibr.]
After calling the procedure follow the instructions on the screen. Description of the messages
with calibration results see in the Table 4.12.

Table 4.12. Description of messages about calibration results of expiratory flow sensor

No Message Alarm condition Operator’s actions


1 Calibration successfully Calibration is completed Continue operation with the
completed successfully device
2 Time out of expiratory flow No messages about calibration Contact the customer service
sensor calibration results from the ventilation con-
troller
3 Calibration cancelled Calibration is cancelled by user Continue operation with the de-
vice
4 Could not set CIVL to Ventilation controller does not Contact the customer service
expiratory flow sensor respond to the calibration re-
calibration mode quests
5 Error: gas mixer failure Malfunction of the gas mixer Contact the customer service
6 Error: no response from gas Malfunction of the gas mixer Contact the customer service
mixer
7 Error: non-zero flow Ventilation controller malfunc- Contact the customer service
tion
8 Error: incorrect data transfer Malfunction of the gas mixer Contact the customer service
rate from GM
9 Error: high pressure in Inspiratory line clogging. Clean the inspiratory line and re-
inspiratory line peat the calibration. If the mes-
sage appears again contact the
customer service
10 Calculation error of User incorrectly followed the ca- Repeat the calibration. If the
approximating coeff. libration instructions on the message appears again contact
screen or malfunction of the de- the customer service
vice
11 Coeff. error for press.sensor in Ventilation controller malfunc- Contact the customer service
insp.line tion

4-53
4.16 Service menu

No Message Alarm condition Operator’s actions


12 Incorrect coeff. for differential Ventilation controller malfunc- Contact the customer service
press. sensor tion
13 Error: no response from power Power unit malfunction Contact the customer service
unit
14 Error: temperature sensor Power unit malfunction Contact the customer service
error in power unit
15 Error: low ambient air Power unit malfunction Contact the customer service
temperature
16 Calibration task stop Calibration task failure Repeat the calibration. If mes-
sage appears again contact the
customer service
17 Monotony error in input table User incorrectly followed the Repeat the calibration. If
calibration instructions on the message appears again contact
screen or malfunction of the the customer service
device
18 Coefficients writing error Ventilation controller malfunc- Contact the customer service
tion
19 Incorrect coeff.for Ventilation controller malfunc- Contact the customer service
press.sensor in exp.line tion

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

4.16.5 Breathing circuit calibration


Breathing circuit calibration is intended for the adaptation of the device to the breathing circuit. It
is recommended to carry out when the device is switched on and especially when switching to
another type of the breathing circuit.
The procedure is called through the menu: [Menu] → [Service menu] → [Calibration] →
[Breathing circuit calibration].
After calling the procedure follow the instructions on the screen.

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.

Table 4.13. Description of messages about breathing circuit calibration results

No Message Alarm condition Operator’s actions


1 Measuring of br.circuit Breathing circuit calibration Continue operation with the
param. succes.completed is successful device
2 Error: insp. pressure sensor Inspiration pressure sensor Reset the device; restart
is not calibrated in not calibrated breathing circuit calibration, if the
3 Error: exp. pressure sensor Expiration pressure sensor message appears again contact
is not calibrated in not calibrated the customer service.

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

No Message Alarm condition Operator’s actions


10 Could not switch CIVL to Ventilation controller does Contact the customer service.
calibration mode not respond to the requests
of breathing circuit
calibration.
11 Monotony error in input table User incorrectly followed the Repeat the breathing circuit
breathing circuit calibration calibration. If message appears
instructions on the screen or again contact the customer
malfunction of the device. service.
12 Coefficients writing error Ventilation controller Contact the customer service.
malfunction.
13 Breathing circuit calibration No messages from Contact the customer service.
time out ventilation controller about
results of breathing circuit
calibration.
14 Gas mixer malfunction Gas mixer malfunction. Contact the customer service.

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

4.17.1 High priority alarms


Table 4.15. High priority 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.

4.17.2 Medium priority alarms


Table 4.16. Medium priority alarms

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.

4.17.3 Low priority alarms


Table 4.17. Low priority alarms
Alarm mes- Reaction of ventilator,
No Alarm conditions
sage operator’s actions
Physiological alarms
1 Plimit reached The pressure in the circuit Special alarms of iSV mode, see the de-
(Plimit reached) reached a value of Pmax - 10 scription in it. 4.17.5. Check the patient con-
cm H2O. dition. Check the alarm limits, adjust them if
necessary.
Technical alarms
2 O2 pres < 1bar Pressure in the oxygen line is The message appears even when the alarm
(O2 pressure < 1 less than 1 bar “О2 pressure (min)” is disabled. Recover the
bar) input pressure in the oxygen line or use al-
ternative oxygen sources.
3 FiO2 sens. Off Operator turned off the FiO2 Further operation of the device is possible
(FiO2 sensor sensor. without FiO2 monitoring. Turn on the FiO2
turned off) sensor to continue the monitoring.

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

Alarm mes- Reaction of ventilator,


No Alarm conditions
sage operator’s actions
6 Capnometer off No connection with the capno- Turn on the capnometer through the menu.
(Capnometer off) meter After restoring of communication message
disappears. If capnometer does not operate,
contact service department. Further opera-
tion of the device is possible without the
mainstream capnometer.
7 Capnometer er- The capnometer error occurred. Further operation of the device is possible
ror without the capnometer. Contact service
(Capno error) department.

8 No CAN-Eth No connection with CAN-Eth Further operation of the device is possible


module (No module without the CAN-Eth. Contact service de-
CAN-Eth mod) partment.
9 No SpO2 module No connection with pulse oxi- Further operation of the device is possible
(No SpO2 mod- metry module without the pulse oximetry sensor. Contact
ule) service department.

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

4.17.4 Informational messages

No Message Alarm Indica- Comment


log tion
zone
1 Power-up (Power-up) x
2 Shutdown (Shutdown) x
3 SpO2 sensor disconnected x To continue monitoring, connect the
(SpO2 sens.disc) pulse oximetry sensor to the device.
4 Capnometer warming (Capno x Capnometer warming. At the end of
warming) warming up the message will auto-
matically disappear.
5 Capnometer turned off by user x To continue monitoring, turn on the
(Capno turn off) capnometer in the device menu.
6 FiO2 sensor replacement (FiO2 x
FiO2 sensor is being replaced.
sens.repl)
7 Calibr. done x Calibration is finished successfully
(Calibr. done)
8 FiO2 cal. done x FiO2 calibration is finished success-
(FiO2 cal. done) fully

9 Calibr. cancel. (Calibr.cancel.) x Calibration is canceled by operator.


10 FiO2 sensor calibration (FiO2 x FiO2 sensor is being calibrated
s.calib.)
11 FiO2 sensor autocalibration x FiO2 sensor is being autocalibrated
(FiO2 s.autocal)
12 Capnometer calibration (Cap- x Zero calibration of capnometer
no calibr.)
13 Breathing circuit calibration x Breathing circuit calibration
(Circuit calibr)
14 Check delayed alarms x Message about the delayed alarms.
(Chk.delay.alrm) Check them in the alarm log.
15 New time is set (New time set) x The new clock time is set by the op-
erator
16 Maintenance (Maintenance) x Message after maintenance proce-
dures.
17 TS calibration (TS calibration) x Touchscreen calibration
18 Ch. net params (Ch. net pa- x The network settings for connecting
rams) the device to the central monitoring
have been changed.
19 Nebulizer is on (Nebulizer on) x Nebulizer is on
20 Suction x
Activation of Sanation function
(Suction)
21 Oxygenation x
Activation of Oxygenation function
(Oxygenation)
22 Alv.recr.man. x Activation of Recruitment maneuver
(Alv.recr.man.) function

4-65
4.17 Alarms

No Message Alarm Indica- Comment


log tion
zone
23 Standby mode x
Activation of Standby mode
(Standby mode)
24 Manual breath x
Activation of Manual breath function
(Manual breath)
25 Technical Message x x Service messages. A detailed de-
(1 or 2) scription of the malfunction and an
indication of the unit in which the
(Tech. msg. x)
malfunction occurred are given in
Table App.5.2, Appendix 5.2.

4.17.5 Special alarms of iSV mode


Special alarms and messages of iSV mode are formed in addition to the standard alarms of all
modes.
High priority alarms:
1. "Target MV is unreachable"
2. "Vt less 4.4 ml/kg" ("Vtmin reached"). This alarm doesn’t depend on the standard tidal
volume alarm and it can not be corrected or disabled (except standard disabling of sound
for 2 minutes).
Low priority alarms:
1. "Plimit reached!"

Conditions of special alarms and messages formation


“Target MV is unreachable” alarm can be generated in two cases:
In the first case the alarm is generated immediately when the change of mode settings is not
compatible with the actual values of existing parameters of respiratory mechanics of the patient.
In the second case the alarm is generated with the delay when it is detected that the real minute
ventilation does not reach the target value. The delay is necessary to achieve the set minute
ventilation, for example in the case of changing the target value from 25 % to 300 % with the
maximum pressure increase in step of 2 cmH2O.
To identify situations when the target minute ventilation can not be achieved, the identification of
the expiratory minute volume stabilization is performed, and if the minute volume actually does
not reach the target value - the alarm is generated. This eliminates false triggering of the alarm.
Alarm “Vt less 4.4 ml/kg!“. This alarm is displayed if Vt is less than Vt min on 3 %, but with delay
at least 20 seconds with the retained alarm condition.
“Plimit reached!“ message is formed when the circuit pressure is Pmax - 10 cmH2O. The in-
crease of inspiratory pressure stops - inspiration continues at the pressure Plimit.

4.17.6 Emergency and technical failure modes


Full emergency mode
The full emergency mode (FEM) is switched on automatically in case of ventilator’s module mal-
function during the operation. FEM cannot be enabled by the user.
Emergency mode of device is intended only to rescue the patient at the technical failures of the
device and to give reserve time to transfer the patient to another type of ventilation. Alarm mod-

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

4.18 Extended respiratory monitoring


Devices equipped with this feature have an interactive button "Monitoring" at the left bottom part
of the screen, which allows to change the appearance of the monitored parameters window in
the left side of the screen (Figure 4.4, position 14).
When you press the "Monitoring" the following window appears:

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).

RESP2 window: RESP 3 window:

Table 4.18. Description of extended respiratory monitoring parameters, RESP 2 window

Name of parameter Designation Additional description


True pressure level in PEEPtot Pressure in the lungs at the end of expiration, taking
lungs at the end of expi- into account the incomplete expiration
ration PEEPtot=PEEP+AutoPEEP. Displayed if both pa-
rameters are measured correctly.
Residual pressure level AutoPEEP Residual pressure in lungs that occurs due to the in-
in lungs completeness of expiration. It is not measured in the
CPAP+PS mode.
Flow at the end of expi- ExpEndFlow Residual gas flow from lungs caused by the incom-
ration pleteness of expiration
Expiratory time con- RCexp (t) Time constant determining the potential rate of
stant pressure change in the lungs during expiratory

4-69
4.18 Extended respiratory monitoring

Name of parameter Designation Additional description


phase RCexp (τexp) = Rexp×Cexp
Inspiratory time con- RCinsp (t) Time constant determining the potential rate of
stant pressure change in the lungs during inspiratory
phase RCinsp (τinsp) = Rinsp×Cinsp
Stress index SI Index characterizes the correctness of PEEP and VТ
selection. It is determined in the CMV/VCV and
SIMV/VC modes for hardware breaths at the rectan-
gular shape of the flow waveform
Respiratory effort index P0.1 Index characterizes the strength of the patient's
breathing attempts. It is measured in cmH2O
Work of the ventilator Wvent Breathing work performed by the ventilator, it is cal-
breathing culated only by the hardware breaths. Work is 0 for
spontaneous breaths
Work of the patient Wspont Work of patient’s spontaneous breath-ing. It is calcu-
breathing lated only by the spontaneous breaths. Work is 0 for
hardware (ventilator’s) breaths

Table 4.19. Description of extended respiratory monitoring parameters, RESP 3 window

Name of parameter Designation Additional description


Inspiratory time, includ- Tinsp Time of the last inspiration, made by ventilator or pa-
ing spontaneous breath tient
Factor of breathing Tinsp/Ttot The ratio of inspiratory time to total duration of the
cycle filling respiratory cycle.
Factor of spontaneous MVe_sp/MVe The ratio of spontaneous breathing minute volume
breathing to the total breathing volume.
Resistance to the exha- Rexp Total respiratory resistance during expiratory phase.
lation
Elasticity of respiratory E Reverse value of static compliance. Measured in
ways (elastance) mmHg in CMV, SIMV, PCV-VG modes.
Resistance of the Rcirc The resistance of the breathing circuit, measured at
breathing circuit breathing circuit calibration
Compliance of the Ccirc The compliance of the breathing circuit, measured at
breathing circuit breathing circuit calibration
Dynamic compliance C (Cdyn) The indicator of compiance of the lungs, chest and
respiratory tract. Dynamic characteristic, calculated
during the respiratory cycle.
Rapid shallow breathing RSBI The dimensionless quantity characterizing the depth
index of patient’s breathing. Measured in CPAP+PS, BiS-
TEP, APRV modes. Only spontaneous breaths are
taken into account when calculating the index.

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

At opening of the extended respiratory monitoring windows the alarm list


becomes unavailable. To access the alarm list, go to the RESP 1 window.

4.19 Features of using virus-bacterial and heat and moisture exchange


filters
When antibacterial filter is in the expiration line the undesirable increase in breathing resis-
tance can occur, especially if the filter is used together with the nebulizer and humidifier. This
can lead to the hard work of the patient's breathing and increased pressure in the respiratory
system (autoPEEP phenomenon). Unwanted pressure increase in the respiratory system of the
patient can be identified by the fact that the flow of exhaled gas by the end of exhalation does
not fall to zero.
Check the virus-bacterial filter and replace it, if it is suspected that is causes autoPEEP increas-
ing.

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.

It is prohibited to use heat and moisture exchange filter with nebulizer or


with the respiratory gas humidifier!

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.

Figure 4.14 – One of the variants of connection of the nebulizer


4-72
4.20 Nebulizer

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.

Figure 4.15 – Connecting of the nebulizer AeroNeb Pro

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

Operation of the nebulizer is prohibited in the following situations:


1. Abnormal alarm conditions such as "disconnection", "occlusion". To re-enable the nebulizer
use menu of device.
2. For the volumetric mode of ventilation such inspiratory volume and time are set, that the per-
formance of the nebulizer plus the breathing gas minimum flow produced by the flow genera-
tor will result in exceeding the inspiration volume specified by the user.
3. At selection of any calibration operations in the service menu.

Features of the pneumatic spray-type nebulizer operation:


• The inaccuracies of the displayed and set tidal volume (volume of inspiration), inspiratory
pressure, minute ventilation will exceed the values specified in the current Manual, because
that additional flow cause by the nebulizer can vary from instance to instance. Use measured
values of expiratory volume and respiratory rate indicated correctly to control the adequacy
of ventilation with the nebulizer.
• Displayed value of the oxygen concentration in the breathing mix (blue EtO2) may differ from
that set on the device one (FiO2). This happens because the device measures and regulates
the oxygen concentration directly on the outlet of the device, and at low flow of breathing gas
from the device and additional large flow from the nebulizer, significant increasing of the set
for the normal conditions EtO2 indication inaccuracy can occur.
• When using the nebulizer it is recommended to disable sidestream oximeter, because the in-
gress of the medicine into the monitoring line can cause its occlusion.
• CIRRUS 2505 nebulizer provides 74 % of particles less than 5 microns in diameter (median
of diameter is 2.75 microns) at the gas mixture flow of 8 lpm. Maximum gas mixture flow is
10 lpm.

Operation of nebulizer is possible only if the device is connected to the high


pressure oxygen line.

4-74
4.21 "Open valve" function

4.21 "Open valve" function


The "Open valve" function reflects the current trend of maintenance and support of spontaneous
breathing at all stages of the ventilation.
The "Open valve" allows the patient to breathe freely during any phase of the hardware respira-
tory cycle.
The "Open valve" function operates in all ventilation modes. In ventilation modes with volume
control (CMV/VCV, SIMV/VC), the "Open valve" function operates in the inspiratory phase.
The “Open valve” function does not operate during static compliance measurement.

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

For your notes

4-76
5.1 Mainstream CO2 sensor (capnometer)

5 OPTIONAL FEATURES OF THE DEVICE


5.1 Mainstream CO2 sensor (capnometer)
External module of breathing gas analysis without sampling (hereinafter – mainstream capno-
meter) is optionally delivered with the device and allows to monitor:
• СО2 concentration at the end (EtСО2) and at the beginning (FiCO2) of the exhalation;
• capnogram (PCO2).
Capnometer operating principle is based on the method of measuring the infrared light absorb-
tion in the absorption spectrum of carbon dioxide.

Only mainstream CO2 sensors supplied by Triton Electronic Systems Ltd.


are compatible with ventilator.

The module includes the mainstream CO2 sensor and ventilation adapters for different types of
patients:

1. Enclosure of the sensor;


2. Ventilation adapter (adult and neonate);
3. Socket for the connection to the ventilator;
4. Cable of the sensor.

Figure 5.1 - Mainstream capnometer

It is not recommended to connect an mainstram capnometer when the de-


vice is switched on.

Connection of the mainstream capnometer:


• Check the sensor window and ventilation adapter. They must be dry and clean. Clean or re-
place the adapter if necessary.
• Connect the adapter with СО2 sensor - combine labels on the adapter and sensor and con-
nect till latching (Figure 5.2).

Figure 5.2 – Connection of CO2 sensor and adapter


• Connect the CO2 sensor to the connector "CO2" port on the front panel (Figure 5.3).

5-1
5.1 Mainstream CO2 sensor (capnometer)

Figure 5.3 – Connecting the CO2 sensor to the CO2 connector of the ventilator

• Turn on the device. The mainstream capnometer will switch on.


• In the graph setting menu (it. 4.12.1) select units of the displayed graphs: PCO2 (%) or PCO2
(mmHg).
• Wait for warm-up interval of mainstram capnometer (message on the display will disappear).

The interval of capnometer warming is about 2 minutes. Herewith a “Capno


warming” message appears in the capnogram field.

• 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.

Figure 5.4 – Connection of the mainstream capnometer to breathing circuit


Windows of the ventilation adapter should be arranged vertically with re-
spect to ground. This reduces or completely prevents contamination of
adapter windows by the patient’s discharge.

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

Mainstream capnometer functioning


During operation mainstream capnometer displays the measured EtCO2 value and capnogram
(if selected in the graph window).
The CO2 concentration can be displayed on the screen as partial pressure (mmHg) and (or) as
the percentage concentration (%) depending on the settings of monitored parameter and graph-
ics in the menu.
During operation capnometer continuously analyzes the state of its technical parameters and
units. Together with capnometer device also has protocol converter.
In case of situations that prevent normal operation, capnometer is disabled with the failure mes-
sage: "Capnometer error" or "Protocol Converter error".
There is no influence on measuring accuracy of the mainstream capnometer in case of high
respiration rate and I:E ration.
The cyclic pressure below 10 kPa does not significantly influence on measuring accuracy of the
mainstream capnometer.
There is no drift in CO2 concentration measuring accuracy: within 6 hours the measuring accu-
racy complies with stated one.
Measurement accuracy:
- CO2 concentration: ±(0,2+0,06Kmeas) %
- CO2 partial pressure ±(0,2+0,06Pmeas) mmHg
Total system response time and rise time: not more than 180 ms
Zero calibration of the mainstream capnometer
Zero calibration of the mainstream capnometer allows to compensate for the optical differences
between the various types of ventilation adapters. These differences are caused by differences
in the material of the window of disposable and reusable adapters and differences in the size of
the adapter window.
Calibration should be carried out with the replacement of the airway adapter, as well as after its
disinfection / sterilization.
The zero calibration procedure of the module is available only upon comple-
tion of the warm interval of capnometer, which is about 2 minutes. At the
warm-up the appropriate message is displayed.

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)

• Select and click on the line "Zero calibration for MS capno".


For correct calibration it is necessary to ensure absence of CO2 in the mea-
suring cell of the adapter used in the calibration during the whole calibration
interval which takes up to 30 seconds.

Checking the alarm limits of CO2 sensor


Before using the mainstream CO2 sensor ensure that alarm system works properly. Follow the
instructions below:
1. Connect the CO2 sensor with airway adapter to ventilator and display the PCO2 graph.
2. Take a breath to the airway adapter, ensure that EtCO2 measurement and PCO2 graph are
displayed on the screen.
3. Set the upper alarm limit of EtCO2 parameter lower then measured value.
4. Ensure that alarm “High EtСО2” is activated.
5. Set the lower alarm limit of EtCO2 parameter higher then measured value.
6. Ensure that alarm “Low EtСО2” is activated.

Disinfection of mainstream CO2 sensor and reprocessing of airway adapters


Please, follow the recommendation stated in it. 3.6.1 for cleaning and disinfection procedure of
mainstream CO2 sensor. For information regarding to reprocessing of airway adapters refer to
it. 3.5.2.

5-4
5.2 Volume capnometry

5.2 Volume capnometry


Optionally the device may be equipped with the function of volume capnometry, which operates
only together with mainstream capnometer. Volume capnometer (sometimes the “volumetric
capnometer” term is used) allows to define the following parameters:
• elimination of CO2 per minute (VCO2), which characterizes the metabolism rate (e.g., high
value indicates sepsis etc.), and reflects the effectiveness of applied respiratory therapy in
dynamics;
• functional dead space (Vd);
• minute alveolar ventilation (MValv).
The calculation method of the CO2 amount per expiration is the combined integration of patient
flow curve and the capnogram from the mainstream capnometer (Figure 5.5).

t1 t2 t3

Flow, Fpat(t)

Capnogram, CO2(t)

Figure 5.5 – Synchronization of the capnogram with the flow curve

СО2 elimination per breathing cycle is:


t3 t2
VCO2i = ∫ Fpat (t ) ⋅ CO 2(t ) ⋅ dt − ∫ Fpat (t ) ⋅ CO 2(t ) ⋅ dt (1)
t2 t1

where: VCO2i – СО2 elimination per i-breathing cycle, units, ml,


СО2(t) – the relative concentration of CO2,
Fpat(t) – the patient's flow rate, lpm.
Measuring units of VCO2 are milliliters given to the patient’s condition (BTPS). Such reduction is
necessary for the correct application of the formulas for calculating other parameters.
Elimination of СО2 per minute is:
n
VCO 2 m = ∑VCO 2i (2)
i =1

where: VCO2m – CO2 elimination per minute,


n – number of breaths during the last minute.

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

where: Vdi – functional dead space, ml,


Vti – expiration volume,
t3

∫ CO 2(t ) ⋅ dt – average concentration of carbon dioxide in the exhalation


t2

t3-t2 – expiratory time


Alveolar ventilation per minute is equal to the difference between the minute respiratory volume
and the amount of dead space ventilation.
n
MValvm = ∑VTi − VDi (4)
i =1

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

VCO2(t ) = Fpat (t ) ⋅ CO 2(t ) (5)

5-6
Cardiac output by Fick

5.3 Cardiac output by Fick


The function for cardiac output calculation by Fick works in conjunction with the volume capno-
metry because it is necessary to know the elimination of carbon dioxide VCO2 and alveolar con-
centration of CO2 for calculation of cardiac output CO.
Monitoring of cardiac output is recommended for all patients subjected to ventilation, as the ar-
tificial ventilation itself leads to induced inhibition of cardiac output.
The accuracy of the cardiac output calculation by Fick is strongly influenced by the following
conditions - the presence of pulmonary shunts, the non-ventilated areas of the lung and other
abnormalities of ventilation-perfusion ratios.
The calculation of cardiac output (CO) is performed by Fick equation:
VCO2
CO = , (6)
( PvCO2 − PaCO 2 ) ⋅ kr

where: CO – cardiac output, ml/min,


VCO2 – minute СО2 elimination, ml/min,
PvCO2 – CO2 partial pressure in the venous blood, mmHg,
PаCO2 – СО2 partial pressure in the arterial blood, mmHg,
(PvCO2 - PaCO2) – delta of blood or arterial-venous difference, mmHg,
Kr – solubility of СО2 in the blood plasma in the blood plasma (equal 0.53 at Т=38 ºС).
For displaying of the digital values of cardiac output and minute CO2 elimination select
CO/VCO2 for the one of the modules of the measurement parameters [Menu] → [Display set-
tings] → [Choose measured par. blocks]:

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:

Button or [Menu] → [Additional functions] → [Cardiac output (by Fick)]:

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

5.4 Pulse oximetry module


Optionally the device can be equipped with built-in pulse oximetry module which allows to moni-
tor:
• oxygen saturation of arterial blood hemoglobin SpО2;
• peripheral pulse rate PR;
• photoplethysmogram.
The delivery kit of the device contains the pulse oximetry sensor, usually finger clip-type one.
On special request other types of pulse oximetry sensors are available.
To connect the sensor to the ventilator hold the connector housing, firmly insert it into “SpO2”
connector of the ventilator (yellow) ensuring their mutual orientation in which the two halves will
join. The connector contains the special fastener that makes impossible accidental disconnec-
tion, for example by pulling for the sensor cable.
To disconnect and undock of the connector it is necessary to take up his enclosure and pull it.
The outer part of the movable connector housing unlocks the fastener while moving. Therefore
unlocking the connector is possible only by pulling by the hand of his enclosure.

To avoid damage of the sensor never try to pull on the cable to unlock the
connector!

Figure 5.7 - Connecting the pulse oximetry sensor to the ventilator

Application of the pulse oximetry sensor to the patient:

Clip-type pulse oximetry sensor


• Use a finger without pressure cuff or arterial catheter.
• Select the finger with good pulse volume and the most close to the size of the sensor (if the
nail polish is applied, remove it prior the application of the sensor). Make sure the finger
completely covers the area of the sensor. Place the sensor so that the cable is along the
back surface of the hand:

5-9
5.4 Pulse oximetry module

Figure 5.8 – Application of the clip-type pulse oximetry sensor

• At impossibility of proper placement of the sensor on the selected finger choose another fin-
ger.

To obtain the necessary accuracy and stability of measurement results fin-


ger and hand must be immovable.

Universal pulse oximetry sensor

Avoid tissue compression during application of the pulse oximetry sensor.

• 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.

Figure 5.9 – Application of universal pulse oximetry sensor to neonate or infant

• 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

Figure 5.10 – Application of universal pulse oximetry sensor to child or adult

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

1 the numerical value of pulse volume in percent;


2 pulse volume bar in the logarithmic scale;
3 the numerical value of SpO2;
4 the numerical values of SpO2 alarm thresholds;
5 photoplethysmogram (PPG curve):
6 numerical value of the pulse rate;
7 the numerical values of pulse rate alarm.
Figure 5.11 – Window of the pulse oximetry channel

• 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).

General or local hypothermia, or labored blood circulation in the hand can


lead to instable operation of device and unreliable result of measurement.

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.

Intravascular administration of dyes such as methylene blue, indigo car-


mine, or any substances containing dyes that alter the usual absorption
of light by blood can lead to erroneous SpO2 measurement results.

Cleaning and disinfection of pulse oximetry sensors


Please, follow the recommendation stated in it. 3.5.1 for cleaning and disinfection procedure of
sensor.

5-13
5.5 Metabolism measurement module

5.5 Metabolism measurement module


The device can be equipped with the module of metabolic parameters measuring by indirect ca-
lorimetry method that allows to measure:
• oxygen consumption VO2, ml/min;
• elimination of CO2 per minute VCO2, ml/min;
according to the measured values module calculates:
• respiratory quotient RQ, relative units;
• resting energy expenditure REE, kcal/day.
The measurement of oxygen consumption VO2 is produced by co-processing of instantaneous
values of oxygen concentration and flow rate.
The measurement of carbon dioxide exhaled by the patient VCO2 is produced by co-processing
of instantaneous values of capnogram and flow rate.
Respiratory quotient RQ is calculated using equation:
RQ = VCO2 / VO2 (7)
Modified Weir equation for the indirect calorimetry is used to calculate the resting energy ex-
penditure:
REE (kcal/day) = (3.941 × VO2 + 1.106 × VCO2) × N (8)

where: REE – total energy consumption (resting energy expenditure) at rest,


VCO2 – minute volume of the exhaled СО2, lpm,
VO2 – minute volume of the consumed О2, lpm,
N - the number of minutes in the day.
Pneumatic system of the metabolism measurement module has two ports. Input “REE” pneumo
connector is located directly on the water trap of the device and is used for the sampling line
connection. Output port (figure.2.1, position 22) is also located on the front panel and is used for
elimination of the test sample to the atmosphere or ventilation system of medical facilities.
Water trap is designed for protection of the pneumatic system of device from liquid.

1- Clamps for securing;


2- Bacterial filter;
3- Pneumo connector for the sampling line;
4- Removable tank - water trap.
Figure 5.12 – Water trap

Preparing for operation


• Install the water trap in the appropriate ports on the front panel of the ventilator.
• Install a heat and moisture exchanging (bacterial) respiratory filter to the patient's tee of the
breathing circuit
• Connect mainstream CO2 sensor to the ventilator (figure.2.1, position 26). Operation of
mainstream capnometer is described in Section 5.1.
5-14
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).

Figure 5.13 – Connecting of the sampling line

Turning on the metabolism measurement module


• Before switching on the metabolism measurement module connect and warm up the main-
stream capnometer (see it.5.1).
• Select row “Metabolism” in the “Monitoring” window to turn on the metabolism measurement
module (Figure 4.4, position 14):

• 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

* - FiO2 readings may appear with a delay of a few seconds.


• During using the metabolism measurement module, it is recommended to display PCO2, PO2
[%] window, where capnogram and oxigram of the respiratory cycle (FiO2(t) - EtO2(t)) are
displayed simultaneously.

Figure 5.14 - Combined graph of capnogram and oxigram


• At displaying of metabolic parameters VCO2, VO2, RQ, REE averaging is performed in the in-
terval of 1 min.
• VO2, VCO2, RQ, REE parameters are stored in the trend and can be viewed later (see it.
4.13).

Metabolism status messages

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.

Table 5.1. Metabolism status messages


No Alarm message Alarm conditions Reaction of ventilator,
operator’s actions
1. Measuring Measurement Metabolism module is working properly.

2. Zero calibr. Zero calibration The message disappeared automatically af-


ter calibration finishing.
3. Warming Warming The message disappeared automatically af-
ter warming finishing.
4. Occlusion Occlusion Check the sampling line and water trap for
occlusion. If it is necessary replace the
sampling line with a new one.

5-16
5.5 Metabolism measurement module

No Alarm message Alarm conditions Reaction of ventilator,


operator’s actions
5. Drying Drying of the line The message disappeared automatically af-
ter calibration finishing.
6. User turn off Turned off by user The message disappeared automatically af-
ter turning on the metabolism module.
7. Off. Occlusion Turned off due to occlusion The message disappeared automatically af-
ter removing the occlusion and turning on
the metabolism module.
8. Emitter malfun Emitter malfununction The ventilator continue operation without
Receiver malf. Receiver malfununction. metabolism module.
9.
Contact service department.
10. Compress malf. Compress malfununction.

11. Press.sens err Pressure sensor error

12. Off. Overheat Off. Overheat

13. Poured chamber Emitter malfununction

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.

Correct measuring of metabolic parameters is provided at the FiO2 values


not exceeding 60 %. This is caused by the features of the current method
of measurement.

For the more accurate measurement of metabolic parameters it is recom-


mended before the start of patient’s ventilation to calibrate the O2 sensor
of metabolism measurement module through [Menu] → [Service Menu] →
[Calibration] → [CAPNO] in accordance with it. 4.16.2.
• Calculation of metabolic parameters is blocked in the absence of fixing of respiration, during
zero calibration and occlusion of sampling line.
• When operating with metabolism measurement module remember that explosion of liquid
through sampling line in its measuring path can affect normal operation, so the device has
number of measures for protection against moisture.
• The main barrier protecting the measuring path from the liquids is water trap for the separa-
tion and condensation of the moisture in the sample and for its accumulation in the special
removable water trap reservoir, which periodically has to be emptied. It takes about 40 hours
for water trap to become full under condition of operating temperature 23°C, patient respira-
tion gas 37° and 100% RH.

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.

Test of pneumatic system hermiticity


• Test of the pneumatic system hermiticity is recommended after each emptying of water trap
and in cases of any doubts in the correct operation, for example, in accuracy of measure-
ment.
• The test can be performed by short time closing of the sampling line inlet connected to the in-
let port of water trap. It should lead to displaying of message "Occlusion" in the status bar in
the "Metabolism" window.
• During test of the pneumatic system hermiticity the pneumatic system should be closed for
the short time, or after two failed attempts to block it the metabolism measurement module
will automatically be turned off with the status message “Occlusion”.
• If test was not successful, disconnect of the sampling line from water trap and directly close
the inlet port of water trap. If message about occlusion appears, the reason is in the tube or
its loose connection with inlet port, and if not, the reason is inside pneumatic system of the
device.
• Firstly ensure that there are no leaks in the water trap reservoir, especially if the malfunction
has appeared after it`s discharge. Carefully check the installation of the removable reservoir
paying particular attention to its integrity and hermiticity. If necessary, replace the water trap
with the new one.
• Also the cause of poor hermiticity may be outworn or damaged sealing rings (O-rings) of
counterpart port of water trap. In this and other cases call customer service to find the rea-
sons of leakage and their elimination.
• To return to the normal operation of the metabolism measurement module close the "Meta-
bolism" window and enter the window again through the "Monitoring" menu.

5-18
5.6 Compensation of endotracheal tube resistance

5.6 Compensation of endotracheal tube resistance


Before the beginning of the ventilation, check the parameters of the used endotracheal tube in
[Menu] → [Ventilation parameters] → [Patient’s parameters] → [Tube parameters]:
• Tube type – endotracheal (ET), tracheostomy (TST);
• The diameter of the tube.

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):

Table 5.1. Application of the endotracheal tube


Default diameter of ET and Permitted range of the diame-
IBW, kg
TST, mm ters of ET and TST, mm
7 - 10 4.5 4.5
10 - 19 4.5 4.5 - 5.5
19 - 25 5.0 5.0 - 6.0
25 - 32 5.5 5.5 - 7.0
32 - 37 6.0 6.0 - 7.5
37 - 50 6.5 6.5 - 8.0
50 - 61 7.0 7.0 - 9.0
61 - 71 7.5 7.5 - 9.5
71 - 101 8.0 8.0 - 10
101 - 130 8.5 8.5 - 10
130 - 150 9.0 9.0 - 10

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

Figure 5.15 – Calculated pressure curve

5.7 “Auxiliary external pressure” function


If the external pressure monitoring function is available, the device has “Paux” fitting (Figure 2.1,
position 15) for auxiliary pressure monitoring with the catheter. In dependence of measuring site
there are two major types of the catheters:
1) tracheal catheter; Tracheal catheter is intended for the monitoring of the actual pressure in
the trachea and the actual PEEP regardless of the ventilation parameters.
2) esophageal balloon catheter for measuring pressure in esophagus or multifunction naso-
gastric catheter for measuring in esophagus or stomach.
The esophageal and multifunction nasogastric balloon catheters are intended mainly for the
monitoring of esophageal pressure to calculate transpulmonary pressure on the inspiration and
expiration phase. In addition, multifunction nasogastric catheter allows to monitor pressure in
the stomach and feed the patient.
Before switching on the device make sure that monitoring line for pressure
measurement disconnected from the “Paux” fitting (Figure 2.1, position
15). Connect the monitoring line when the device is switched on.

Auxiliary external pressure displaying


To display the window of digital values of maximum, medium and minimum auxiliary external
pressure select Paux for one of the blocks of measurement parameters in [Menu] → [Display
settings] → [Choose measured par. blocks]:

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

Figure 5.16 – Additional external pressure curve

At selection of the "Loop" type of graphs the spirometric loop V/Paux becomes available:

Figure 5.17 – Additional external pressure curve

Assembly of the circuit of external auxiliary pressure measurement in trachea


Assembly scheme for pressure measurement in trachea is shown on Figure 5.18.

Figure 5.18 – Connection scheme of the tracheal catheter

• 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

Measurement of external auxiliary pressure without respiratory (virus-


bacterial filter) is not allowed.

• Insert the adapter of the catheter into the flex tube with connector:

Figure 5.19 – Inserting the adapter of the catheter

• 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)

Assembly of the circuit of external auxiliary pressure measurement in esophagus or


stomach
• Follow the procedure operation instructions supplied with the catheters.
• Connect a hydrophobic (virus-bacterial) filter with the Luer connector and monitoring line to
the Paux pressure port (Figure 5.22).

Figure 5.22 - Connection of the esophageal balloon catheter or multifunction nasogastric cathe-
ter to the ventilator

Indication of transpulmonary pressure


To display the calculated transpulmonary pressure select the Ptp value for one of the mea-
surement parameter blocks through [Menu] → [Display settings] → [Choose measured
par.blocks]:

5-23
5.8 Operating with low pressure oxygen source

Transpulmonary pressure is calculated in the ventilator on each respiratory cycle according to


the following algorithm:
Ptp = (Paw end of inspiration - Paw end of expiraiton) - (Pes end of inspiration - Pes end of expiraiton),
where: Pes – pressure in the esophagus, (Paux=Pes),
Paw – airway pressure.
Transpulmonary pressure shall be within: 0 < Ptp < 25 cmH2O.
Shifting of the Ptp graph into negative area (Ptp < 0) means that esophageal pressure Pes is
higher than PEEP, the PEEP adjustment - increasing is required.

5.8 Operating with low pressure oxygen source


Optionally the device can be equipped with an additional inlet oxygen nipple for connection to
the low-pressure oxygen source.
Low-pressure oxygen sources include all types of concentrators with a pressure up to 0.5
kgf/cm2 (bar). It is recommended to use oxygen concentrators with a capacity of at least 5 lpm.
• Connect the device to the low-pressure source using oxygen hose and quick-release con-
nector from the delivery kit of the device.

It is prohibited to connect pressure sources with operating pressure more


than 0.5 kgf/cm2 (bar) to the low-pressure connection because it can lead
to device failure.

• 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.

5.9 Data exchange with computer


Communication interface for connection to a personal computer (PC)
The devices equipped with the IEEE 802.3 Ethernet communication interface can operate within
information system. The device can be connected directly to the computer or to the Ethernet
router - in this case several ventilators can be connected to the PC. If the ventilator is connected
to the router, the computer can be remote.
In the simplest case it is necessary to connect the ventilator and PC using a standard UTP ca-
ble with RJ45 connectors. For connection use the "Ethernet" connector on the back of the de-
vice.
The ventilator transmits graphical curves, measured parameters of the ventilator, monitored pa-
rameters of respiratory mechanics.

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.

Saving trends to USB-flash


Devices equipped with a USB connector have the function of saving the selected trend fragment
to external USB flash memory device. The trend file is saved in the text format .csv and can be
viewed in EXCEL, CALC OpenOffice programs or in a similar spreadsheet program. The file
records all 34 parameters at a rate of 1 per minute, stored in the trend. The text encoding in the
file is 866 Cyrillic, separator is semicolon (;).
Example for Excel 2003:
Select the "Data" tab in the "Import external data" item (select "Receive external data" in other
versions of Excel), select the "Import data" item (in other versions of Excel choose "From text"
instead). In the new "Select data source" window, open the current file from USB-flash. In the
appeared text editor, follow the steps and set the following parameters:
1 step: data format - with delimiters, file format - under the number 866 (Cyrillic (DOS));
2 step: delimiter character - semicolon;
5-25
5.9 Data exchange with computer

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

6 MAINTENANCE OF THE DEVICE


Before performing any maintenance, ensure that the device and its accesso-
ries are properly disinfected.

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.

6.1 Maintenance schedule


№ Routine Periodicity Description
1. Visual inspection and test of controls
monthly it.6.2

2. Cleaning of fan filters


monthly it.6.3

3. Check of sealing gaskets of oxygen hose and


1 time in 3 months it.6.4
water trap
4. Check of the filter-regulator 1 time in 3 months it.6.5
5. Check of the expiration valve monthly it.6.6
6. Check and calibration of the FiO2 oxygen sen-
monthly it.6.7
sors and the metabolism measurement module
7. Check of built-in accumulator
1 time in 3 months it.6.8

8. Calibration of the exhalation flow sensor monthly it.4.16.3


9. Check of the compliance of the set and dis-
monthly it.6.9
played volume of inspiration and expiration
10. Check of PEEP monthly it.6.10
11. Check and calibration of mainstream CO2 sen-
monthly* it.6.11
sor
12. Breathing circuit calibration monthly** it.4.16.5

* - 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 Visual inspection and test of controls


The device shall not have mechanical damages and signs of liquid ingress. The shell of the
power cord shall not have any damage or sharp bends.
Buttons and encoder shall clearly respond calling the appropriate action. There shall be no false
responses. If the control touch button area you press is offset relative to its graphical designa-
tion calibrate the touch panel through [Menu] → [Service menu] → [Calibration] → [CIVL] →
[Touch screen calibration].

6.3 Cleaning and replacement of fan filters


Remove the plastic grid of the cooling fan and fresh air fan on the rear panel of the device (Fig-
ure 2.2, positions 2, 8), easily pulling them toward to you. Remove the dust filters and clean
them by washing in soap solution, rinse in clean water and dry. In the case of their substantial
deterioration use the new dust filters supplied (2 pcs.) or order them through the service organi-
zation.
Make sure that filters are completely dry, set them back in their place and snap the plastic grids
of the fans.

Figure 6.1 – Cleaning and replacing of the dust filter

6.4 Check of sealing gaskets


Check the condition of the sealing gaskets of the:
- oxygen hose;
- water trap fittings of sidestream capnometer (indirect calorimeter).
The sealing gaskets should not have any visible damage or undue strain.
If necessary replace the gasket ordering them at the manufacturer.

6-2
6.5 Check of the filter-regulator

6.5 Check of the filter-regulator

Always disconnect the oxygen hose during filter-regulator maintenance.

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.

Figure 6.2 – Disconnection of filter-regulator housing

6.6 Check of the expiration valve


Detach removable part of the expiration valve, check the condition of the membrane (see Figure
6.3).

Figure 6.3 – Disconnection of expiration valve housing

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).

Figure 6.4 – FiO2 sensor replacement

Disposal of electrochemical oxygen sensors shall be performed similarly to batte-


ries and accumulators by collection in specialized containers for further reprocess-
ing according national rules.

6-4
6.8 Check of built-in accumulator

6.8 Check of built-in accumulator


Fully discharge the accumulator. Connect the device to the mains ("Battery" and "Power" indica-
tors should be green). Fully charge the accumulator ("Battery" indicator will be off). Check the
operation time of the device from the fully charged accumulator. Recharge the accumulator.
To maintain the capacity and extend the lifetime of the accumulators, train them least 1 time in 3
months.
If necessary replace the accumulator. For this purpose:
• Disconnect device from mains power.
• Remove the expiration valve, tilt the device to the front of the housing, providing access to
the battery compartment cover.
• Remove the 4 screws of battery compartment cover. Pull out the cover and take it out of the
slots in the housing of the device (Figure 6.5)
• Successively take out the accumulators from the housing. If necessary use a flat screwdriver.
• Disconnect the accumulator cable and the jumper between the accumulators.

Figure 6.5 – Replacement of accumulator

• Connect new accumulators observing polarity.


• Install the accumulators in the reverse order. At installation observe that the wires are not
pinched, but evenly located inside the compartment.

Dispose accumulators according to the manufacturer's instructions, for example,


by collection in specialized containers for further processing.

It is allowed to use accumulators with the characteristics specified in this


Manual for replacement.

6-5
6.9 Check of the set tidal volume

6.9 Check of the set tidal volume


To make the test:
• Assemble the scheme shown on Figure 6.6.

Figure 6.6 – Check of the set tidal volume


• Connect the ventilator to the oxygen source and switch on the device.
• Set the following ventilation modes and parameters:
Mode CMV/VCV; Patient: child;
FormFlow = rectangular; Ttrig = 93 %;
FiO2 = 21 %; Pmax = 60 cmH2O;
1
RB = 15 /min; PEEP = 3 cmH2O;
VT = 200 ml; Tinsp = 1.2 sec;
Ftrig = 10 lpm.
• In the service menu of the device turn off the H2O correction (choose correction by ATP con-
dition on inspiration).
• In one of the measurement parameter blocks select the indication of Vexp / Vinsp (the inspi-
ration and expiration volumes).
• Consistently set the values of the tidal volume VT = 400 ml, 600 ml, 800 ml, and make sure
that the measuring error of the expiratory volume Vexp and the inspiratory volume Vinsp
does not exceed ± 15%.
If the measurement error exceeds ± 15% calibrate flow sensor on expiration (it. 4.16.3). If it
doesn’t help, device shall be sent for repair.

6.10 Check of PEEP


• Assemble the scheme on Figure 6.6. Connect the breathing circuit to the device. Connect the
endotracheal tube (ETT) to the patient tee. Install the breathing bag on the patient tee, pre-
viously ETT shall be placed in the breathing bag (3L).
• Turn on the device, set any mandatory ventilation mode with respiratory rate RB = 15-20
1/min.
• Consistently set the parameter PEEP = 0, 5, 10, 20 cmH2O. After 3 - 5 respiratory cycles
monitor the corresponding values of the PEEP being displayed. Deviation from the set value
shall not exceed ± 2 cmH2O.

6.11 Check and calibration of mainstream CO2 sensor


Check the cleanliness of the mainstream CO2 sensor and the reusable airway adapter surfaces,
especially their optical elements. Contamination and moisture can cause decreasing of the CO2
concentration measuring accuracy.
If necessary clean and disinfect the mainstream CO2 sensor and the airway adapter in accor-
dance with it. 5.1, to make surfaces are dry and clean.
Calibrate mainstream CO2 sensor:
6-6
6.11 Check and calibration of mainstream CO2 sensor

• 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

For your notes

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

For your notes

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.

For countries covered by Directive 2002/96/EС (WEEE):


The device is not intended for household use and is not subject to disposal with
standard electrical and electronic equipment.
For detailed information contact your local sanitation and environmental authorities or waste
disposal companies.
Before disposal the device shall be cleaned and disinfected in accordance with the require-
ments of section 3.6 of current Manual.
Accumulators and O2 sensors shall be disposed as hazardous waste in accordance with the re-
quirements of applicable laws and regulations. Their extraction for recycling shall be made by
organizations authorized by Triton Electronic Systems Ltd. for the maintenance of the device.

10-1
8. Transportation 9. Storage 10. Disposal

For your notes

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.

Warranty service is not provided for:


• not following the operating instructions stated in user manual;
• absence of user manual or serial number on the equipment, as well as incomplete delivery
kit equipment;
• equipment malfunctions caused by impacts (falls), violation of the rules of packaging, storage
and transportation, ingress of foreign objects or liquids, voltage drops or inconsistency with
power supply standards and other similar external factors;
• faults caused by the use of non-recommended or low-quality spare parts and consumables;
• absence of mandatory periodic maintenance;
• detection of attempted repairs by persons and organizations not authorized by the manufac-
turer;
• normal wear and tear of accessories, spare parts and consumables.
Keep the current user manual for the entire warranty period. Make sure that the commissioning
and maintenance repair data are made timely and correct.
For free consultations about operation and maintenance please contact the manufacturer by
phone. +7 (343) 304-60-51, e-mail to [email protected], or local distributor in your region.

11-1
11.Warranty

11.2 Guarantee procedure


In order to use the guarantee service you need:
1. Note the following information:
• equipment name, serial number and date of manufacture (on the back of the equipment);
• commissioning date by a representative of an authorized service center (in current manual or
the commissioning act);
• the nature of the malfunction.
2. To specify with a representative of authorized service center nature of the manifestation of
the malfunction. When confirming the malfunction, agree on procedure and terms of delivery
of the equipment to service center or terms of service engineer's departure to the place of
operation.
3. To deliver the equipment to service center assemble a complete delivery set of equipment
and pack it in order to avoid damage to the equipment during transportation. It is preferable
to use the equipment original package.
4. After delivery of the equipment to service center, you will be informed about the results of
technical examination and the timing of receipt of the repaired equipment in case of recogni-
tion of the case as a guarantee.

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.

11.3 Address for notes and complaints


Production site 12/5 Sibirskiy Trakt str. 620100 Ekaterinburg, Russia
Service phone: +7 (343) 304-60-51
Post address p/b 522, 620063 Ekaterinburg, Russia
E-mail [email protected]
Web-site www.treat-on.com

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

13 COMMISSION DATE MARK


Commission date ____________________________
day, month, year
Operating company (customer):
_______________________________________________________________________
company name
____________________________________________________________________________
responsible representative, position, signature, name

stamp

Service company (provider):


______________________________________________________________________
company name
____________________________________________________________________________
responsible representative, position, signature, name

stamp

12-1
13 commission date mark

For your notes

12-2
14.1 Device maintenance (MA)

14 MAINTENANCE AND REPAIR DATA


14.1 Device maintenance (MA)
This section is filled by a representative of the service personnel or service organization. The
frequency and order of maintenance are specified in Section 6 of current Manual.

Company, position, MA Signature of MA re-


MA No MA date Remarks, works performed
resp.person sponsible person

14.2 Device repair


Repair Company, position, repair Signature of repair re-
Malfunction Works performed
date resp.person sponsible person

14-1
14 Maintenance and repair data

For your notes

14-2
Appendix 1.1 Description of CMV / VCV mode

APPENDIX 1 DESCRIPTION OF VENTILATION MODES


Appendix 1.1 Description of CMV / VCV mode
In CMV/VCV mode (Controlled Mandatory Ventilation / Volume Control Ventilation) the patient
receives the set tidal volume. Flow curve is rectangular or decreasing (as shown below), ac-
cording to doctor’s choice. The device provides the set volume of a respiratory cycle at the set
respiratory rate with the set duration of the respiratory cycle.

Respiratory cycle with com-


Paw pliance measurement

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

Appendix 1.2 Description of CMV / PCV mode


In CMV/PCV mode (Controlled Mandatory Ventilation / Pressure Control Ventilation) the breath
is carried out at the set pressure with the set respiratory rate and duration of the respiratory
cycle.
The level of pressure is set by inspiration pressure Pi which is supplied over PEEP and rigidly
held during inspiration. The device displays the measured tidal and minute breath volumes.
The minute breath volume is measured on an exhalation by summation of expiratory volumes
within a minute.

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

Appendix 1.3 Description of SIMV/VC, SIMV/PC, SIMV/DC modes


SIMV/VC, SIMV/PC, SIMV/DC modes - Synchronized Intermittent Mandatory Ventilation with
volume control, pressure control and double control.
In these modes pressure support of spontaneous patient’s breath (by PS - Pressure Support) is
also realized. If device detects independent respiratory attempts of the patient, these breaths
are carried out synchronously with them, in case of absence of attempts - automatically upon
the end of the set interval of expectation. In intervals between ventilator’s breaths the patient
can independently breathe through the circuit.
Independent breaths of the patient are supported by the set level of pressure, invariable
throughout all time (support pressure, PS). Criterion of the spontaneous breath termination is
flow falling to the set level ETS from the maximum. Reserve criterion is time, if the flow does not
manage to decrease to ETS for the maximum allowed inspiratory time.
Decreasing of the mandatory breaths frequency and tidal volume (inspiration pressure) pro-
motes increasing of part of independent breath, and on the contrary.
The SIMV/DC mode is analogue of the SIMV/PC mode, except that the ventilator’s breath is
carried out according double control (DC) method similarly to the PCV-VG mode.
Trigger window has not al-
ready started, so there is a PS is usually less
spontaneous inspiration: no than Pi
inspiratory pause, end of in-
spiration by ETS
Paw
Pi

TrigWnd = 20 % PEEP

Flow Fmax t

ETS,
% from Fmax

Figure App. 1.3 – SIMV mode

App.1-3
Appendix 1.4 Description of CPAP+PS mode

Appendix 1.4 Description of CPAP+PS mode


CPAP+PS (Constant Positive Airway Pressure) is spontaneous breathing with the set positive
pressure in the airways. The device supports the spontaneous inspiration attempt with pressure
(PS).
Cycle of inspiration support is triggered at the activation of the inspiration trigger (pressure or
flow).
The rate of inspiratory pressure rise is set by Pramp parameter.
The pressure at the peak of inspiration equals to PIP = PEEP + PS. Criterion of the end of
spontaneous inspiration is flow drop to the set flow ETS value from maximum (expiratory trigger
or trigger of the end of inspiration).
Reserve criterion of end of inspiration is time, if the flow does not have time to decrease to ETS
for the maximum allowed inspiratory time Tinsp. In CPAP+PS mode the maximum inspiratory
time Tinsp is limited to 4 s.
In the CPAP+PS mode the Tinsp parameter defines the inspiratory time if trigger of the end of
inspiration was not activated before (for example, because of the leakage in the circuit). If lea-
kage is detected or suspected, activate the leakage compensation function.
At the absence of spontaneous breathing through a pre-set time Tapnea, apnea alarm is trig-
gered and the ventilator switches to the APNEA.

App.1-4
Appendix 1.5 Description of BiSTEP mode

Appendix 1.5 Description of BiSTEP mode


BiSTEP mode (analogue of BiPAP*) is the spontaneous breathing mode with two levels of posi-
tive airway pressure with the possibility of pressure support. The patient may breathe through
the ventilator in the both phases of circuit pressure. The transition from low to high pressure
phase is essentially pressure controlled inspiration; the transition from high pressure phase is
expiration. However, unlike the PCV mode inspiration and expiration can be separated with
substantial time interval during which the patient breathes spontaneously. The device separate-
ly calculates the volumes of hardware and spontaneous breathing.
At the coincidence of spontaneous breathing cycle with the transition between phases, the ven-
tilator goes from low to high phase synchronizing process with the patient's inspiration, and from
high to low phase synchronizing the transition to the expiration.
Spontaneous breaths are supported by the device, as well as in other modes.
Criterion for the start of the inspiration cycle is the activation of the inspiration trigger (flow or
pressure). The criterion for the end of spontaneous inspiration is a flow drop to the set value
ETS from the maximum. Reserve criterion is time, if the flow does not have time to decrease to
ETS for the maximum allowed inspiratory time.
In the absence of spontaneous breathing through a preset time Tapnea, apnea alarm is trig-
gered and the device switches to the APNEA mode.
Practically modes similar BiPAP (BiLevel, DuoPAP, etc.) are applied unfairly rare. In particular,
this is due to the fact that the processes in these modes are very dependent on the setting of
parameters. Therefore the detailed description of the features BiSTEP mode is shown below.
Let's consider two cases, when the operation depends on the pressure setting.
Case 1 - the total pressure Plow + PS is less than pressure of the high phase Phigh. On the low
pressure phase spontaneous inspiration will be supported by pressure PS. On the high pres-
sure phase spontaneous inspiration/expiration will be performed on the constant pressure
background, similarly to CPAP+PS. The curve of the airway pressure will have the following
form (see Figure App. 1.3):

P(t)

Phigh

PS

Plow

Thigh Tlow Thigh

Figure App. 1.3 – Airway pressure curve

* BiPAP® is a registered trademark of ″Respironics Inc″


App.1-5
Appendix 1.5 Description of BiSTEP mode

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

Figure App. 1.6 – Airway pressure curve

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

Appendix 1.6 Description of NIV mode


The NIV mode (NIV - non-invasive ventilation) is spontaneous breathing through a face mask
with the predetermined positive pressure in the airways and the predetermined spontaneous
breaths support. This mode is very similar to CPAP+PS, but there are minor differences - they
are associated with the leakage at non-invasive support:
1. The NIV mode always operates with leakage compensation.
2. FiO2 is set in the range of 21 - 70 %.
3. The trigger of the spontaneous inspiration is set only by pressure (it is more "rough").
4. Special indicator Facc is used for the mode.
5. In the absence of spontaneous breathing, the ventilator enters APNEA mode. Unlike other
ventilation modes when the doctor can choose the APNEA mode either by pressure or by
volume, in NIV mode APNEA mode operates only by pressure.
Breathing circuit calibration [Menu] → [Service menu] → [Calibration] → [Breathing circuit cali-
bration], measuring the circuit parameters shall always be carried out after circuit change and
autoclaving. This is suitable for any mode, but is especially important for the transition from in-
vasive to non-invasive ventilation and vice versa.
Due to the presence of the leakage model, the ventilator can compensate large leak up to 90
lpm. At the large leakage FiO2 drop can occur.
To control the size of the leak, the user should turn on its displaying in any of the rectangles of
measured parameters block via [Menu] → [Display settings] → [Choose measured par. blocks]
→ [Leak]. In the LEAK field two leaks will be displayed: peak leakage at the inspiration and av-
eraged leakage during expiration. Leakage will depend upon the pressure in the inspiratory line,
the degree of fitting of the mask to the patient and/or the number of open ports on the mask.
Using of the mainstream capnometer at NIV is inappropriate, because the expiration can go
through the existing gap in the mask and will not get into the chamber of the mainstream cap-
nometer.

App.1-8
Appendix 1.7 Description of APRV mode

Appendix 1.7 Description of APRV mode


APRV mode (Airway Pressure Release Ventilation) is ventilation with pressure release in the
airways; it is an extension of BiSTEP mode. The patient in this mode breathes independenly
with a predetermined level of pressure support.
If the patient requires a high-pressure CPAP (or PEEP), a significant reserve of non-exhalted
gas is created in the lungs of the patient. This residual gas accumulates a significant amount of
carbon dioxide that may hinder its excretion to the environment and contributes to increasing of
carbon dioxide level in the arterial blood. It is resulted in the danger and the preconditions for
the hypercapnia.
P(t)
PS

Phigh

Plow

Thigh Tlow

Figure App. 1.8 – Device operation in APRV mode

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

Appendix 1.8 Description of PCV-VG mode


PCV-VG mode is the mandatory ventilation mode with guaranteed delivery of the target tidal vo-
lume at the lowest possible pressure. It is more effective mode of substitute ventilation than
VCV and PCV, because it combines the strengths of both without imperfections.
The PCV-VG mode functionally repeats the CMV / PCV mode with one exception: instead of the
target inspiratory pressure, the user sets the target inspiratory volume. The inspiration pressure
is adjusted by the ventilator with every new inspiration depending from the target volume.
The PCV-VG mode is intended for use in patients practically without independent breathing; the
patient is too weak to allow his respiratory activity actually control the ventilation. The clinical ef-
ficacy of the mode is associated with the more regular shape of inspiratory pressure curve,
more homogeneous mixing of air in the lungs and the precise inspiration volume.
At initial mode settings, select the appropriate value of Pramp. The higher is the target volume,
the greater is the value of Pramp. For example, at the high set target volume and low Pramp,
situation can occur when the inspiratory target volume will not be achieved.
PCV-VG is the mandatory ventilation mode. To increase the flexibility of the mode, it is com-
bined with the A/C (assisted control) mechanism. It is mechanism of trigger window for the
mandatory breaths. The user can allow the inspiration to be initiated by the patient by the
TrigWnd parameter (trigger window). The trigger window is the time from the end of expiration
to the beginning of the next expiration, the duration of the trigger window can be set from 0 to
100 % of the specified time interval.
• When TrigWnd is set to 0%, patient’s inspiration attempts are ignored by the device, each
breath is performed according to the algorithm set by the doctor. Such setting is necessary,
first of all, for patients at known condition that excludes attempts of spontaneous breathing.
• If TrigWnd is set to 100%, patient’s inspiration attempt leads to inspiration according to the
ventilator’s rules at any time point between the beginning and the end of the expiration. If
there were no patient’s attempts, ventilator provides a breath. Such duration of the trigger
window is optimal for the patients whose body is able to reflect the inspiration needs, but at
the same time it is too weak to breathe on its own.
• Middle TrigWnd values are set when the doctor has "limited trust" in the patient's organism;
requests for inspiration are accepted, but not immediately after the end of the previous inspi-
ration.
Thus, formally, spontaneous breaths are forbidden in PCV modes, but using of the trigger win-
dow allows to cancel the waiting for the end of expiration and start ventilator inspiration earlier.

App.1-10
Appendix 1.9 Description of APNEA mode

Appendix 1.9 Description of APNEA mode


The apnea ventilation mode (APNEA) is not independent full mode of ventilation. In fact it is a
mechanism to ensure patient’s safety at the suddenly stop of breathing in modes with support of
patient spontaneous breaths. The ventilator automatically switches to the apnea ventilation
mode when it detects the absence of respiratory cycles in the set time interval.
Functionally the apnea ventilation mode is CMV mode with preset parameters, with pressure or
volume control.
Type of the apnea ventilation (with volume/pressure control) and time of absence of patient’s
respiratory activity (Tapnea, in seconds) are defined by the user.
Although the apnea parameters have default values, the doctor does not
have the right to ignore the apnea mode setting, because it is one of the
steps to ensure patient safety.
Although the apnea parameters have default values, the doctor does not
In the apnea ventilation mode with volume control respiratory rate RB and tidal volume Vapnea
are set automatically but can be adjusted by the user.
In the apnea ventilation mode with pressure control respiratory rate RB is set automatically ac-
cording to the same rules as the function of the ideal body weight. The target inspiratory pres-
sure in the apnea ventilation mode with the pressure control Piapnea is set by the user.
In the NIV mode only apnea ventilation with the pressure control is available.
Apnea ventilation mode is not intended for the long-term patient ventilation. Therefore the tran-
sition of the ventilator to this mode triggers an alarm, attracting the attention of the user, show-
ing the need for making a decision about the future strategy of ventilation. The parameters of
this mode most often are not optimal for the particular patient. They are offered by the device on
the basis of the ideal body weight of the patient at the transition to any ventilation mode with the
possibility of correction of apnea parameters by user.
Exit from the apnea ventilation mode and automatic recovery of the last ventilation mode after
synchronization with the breathing cycle can be done by two ways:
• Press the encoder knob. Returning to the previous ventilation mode will be synchronized with
the respiratory cycle and realized at the beginning of inspiration.
• If trigger window was set, and the device will generate two consecutive breaths triggered by
the patient with the type and value of trigger taken from the previous ventilation mode before
the apnea. If before the apnea one of the modes BiSTEP, APRV, NIV was active, then the
trigger window at the apnea ventilation will be set to 100 %. Returning to the previous
ventilation mode will be synchronized with the respiratory cycle and realized at the beginning
of inspiration.
In the APNEA mode PEEP is always set at 5 cmH2O.

App.1-11
Appendix 1.10 Description of the intelligent adaptive ventilation iSV

Appendix 1.10 Description of the intelligent adaptive ventilation iSV

Appendix 1.10.1 Function of iSV mode. General description


ISV mode is an integral ventilation mode - with the support of patients without spontaneous
breathing and with any level of spontaneous respiratory activity.
The mode includes both mandatory (PCV-VG) and assisted ventilation (CPAP+PS). The algo-
rithm of its time cycles reminds SIMV. At the same time the mode is similar to MMV, but all the
basic parameters that ensure patient required minute ventilation are automatically set in accor-
dance with data of his respiratory mechanics.
If the patient has no spontaneous breathing, iSV provides hardware breaths with optimal values
of VТ and RB. At the appearance of spontaneous breaths the mode provides pressure support
the level of pressure depends on the respiratory activity of the patient. The more active is the
patient, the lower support level he needs.
Its differences from other modes:
• provides automatic control of the set MV;
• automatically adjusts the proportion of mandatory and assisted ventilation depending on the
patient's respiratory activity;
• automatically determines the parameters of control and support pressure;
• automatically in real time determines the optimal respiratory rate and target tidal volume on
the basis of the patient's respiratory mechanics, providing the minimum work of breathing;
• automatically adjusts the I: E ratio;
• prevents the situation with the development of perceptible autoPEEP;
• provides ventilation at the minimum possible airway pressure (uses double control);
• automatically calculates static and dynamic (in real-time, taking into account RCexp) limits of
the safe ventilation for Vt, RB and I:E, ensures strict compliance of the ventilation parameters
for each inspiration with these limits;
• provides the best conditions for both the patient and the physician at the apnea;
• if necessary, provides the MV adaptation depending on the actual needs of the patient;
• it is designed for ventilation from intubation to extubation and was originally designed for se-
paration of patients from ventilator as his spontaneous respiratory activity is recovered;
• has minimum basic control settings: % MV for ventilation and FiO2 and PEEP - for oxygena-
tion.
The mode provides guaranteed minute volume regardless of the degree of spontaneous respi-
ratory activity of the patient. In the absence of spontaneous breathing it provides hardware in-
spirations with double control (PCV-VG). In the presence of spontaneous respiratory activity of
the patient the mode becomes identical to CPAP+PS, but the support pressure level PS is au-
tomatically adjusted to provide the set MV. As the recovery of spontaneous breathing, the level
of the support pressure is reduced to the minimum of 5 cmH2O.

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

Appendix 1.10.2 Assessment of respiratory rate


The respiratory rate RB is calculated by Otis equation in the modification suggested by Y.V.
Kofman, engineer of Triton Electronics Systems Ltd. Unlike the commonly used Otis equation,
this modification does not require multiple iterations and does not require initial RB value, and
therefore is more convenient and fast.

Appendix 1.10.3 Assessment of the tidal volume


Tidal volume is determined by dividing the target minute volume to the target frequency:
Vt = MV / RB.

Appendix 1.10.4 Limits of the safe iSV ventilation. General concepts


Not all versions of tidal volume to the respiratory rate ratio determined by the Otis equation are
safe for the patient.
At very low frequency, respectively, large tidal volume is required for the target MV that can
cause volumotrauma of the patient's lungs. At the same time at the high respiratory rate, tidal
volume approaches the dead space volume. It results only in dead space ventilation, and the
absence of alveolar ventilation. Such conditions do not occur at the small deviations of respira-
tory mechanics parameters (the compliance, resistance) that are transported to the Otis equia-
tion through the expiratory constant. However at the more significant deviations of these para-
meters from the normal values, the risk volumotrauma or hypoventilation increases dramatically.
The graph connecting tidal volume and inspiration frequency for the current MV, looks approx-
imately as follows:

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

Appendix 1.10.5 I:E ratio, medical aspects


Inspiration:expiration (I:E) ratio of a healthy person, as well as of mammals is based on the
physiology of breathing. Expiratory time is usually 2 – 3 times more than inspiratory time. The
natural I:E ratio lies typically in the range of 1:2 – 1:3. This is due to the fact that the breath is
always active and caused by work of the inspiration respiratory muscles (diaphragm, the inter-
costal muscles, straightening ribs).
Expiration at quiet condition is always passive and its implementation requires more time. Full
expiration time takes at least 4 expiratory constants.
At the active physical activity the respiratory rate (and further I:E ratio) increases to eliminate
the carbon dioxide. At the very heavy work the respiratory rate and tidal volume can be in-
creased significantly, expiratory time may become less than 3RC and even 2RC because of
enabling of the expiration muscles. So expiration takes less time than in the quiet state (effect of
pseudo decreasing of the expiratory constant).
At the patient's airway pathology, as well as heavy state due to sepsis, inflammation, fever, ke-
toacidosis at diabetes and so on, significant changes happens in the pattern of breathing.
There is a relationship between the number of expiratory constants in the breathing cycle (T to-
tal) defined by the Otis equation and respiratory mechanics of the patient. The more constants
are "placed" in the breathing cycle, the harder are the lungs, respectively, the less is com-
pliance, respectively, I:E ratio tends to 2:1. And conversely, the less number of the constants
are in the breathing cycle, the higher is the resistance, I:E ratio tends to 1:4 giving priority to ex-
piration.
With the height of the real patient and standard values of compliance and resistance for each
patient height (there is a direct correlation), ideal RB for the patient can be calculated according
to the Otis equation. Comparing this value with the real RB, that takes into account also the
safety limits, operator can get the difference. For example, subtract from RBideal the RBreal,
and get a certain value. If the difference is not large, it is recommended to ventilate with I:E =
1:2. If difference is negative (depending on the degree of deviation), ventilate with 2:1. If posi-
tive, tend to use 1:4.

Appendix 1.10.6 Calculation of the respiratory cycle phases (I:E)


Range of automatic I:E settings is from 2:1 to 1:4. It is also the boundary for correcting of I:E
within the range. The I:E ratios, when the inspiration is longer than expiration are inverse and
requires special enabling.
Algorithm of I:E control supports the following rules:
• Minimum expiratory time: Te min ≥ 2RC;
• Minimum inspiratory time: Ti min ≥ 1 RC, but not less than 0.5 seconds for adults and child-
ren weighing more than 10 kg IBW; in children less than 10 kg IBW - not less than 0.35
seconds.
In the advanced settings the restriction to the inversion "Allow IRV in iSV" (inverse ventilation -
IRV) is provided. IRV is disabled by default. To enable set the range I:E from 2:1 to 1:4, to disa-
ble set 1:1 - 1:4. This is caused by the fact that in some medical facilities ventilation in the inver-
sion mode is not performed.

App.1-14
Appendix 1.10 Description of the intelligent adaptive ventilation iSV

Appendix 1.10.7 Start of iSV mode


After running of the iSV mode the device delivers 3 test breaths in the mode
SIMV/PC+PS. Pi = PS.
Parameters of starting breaths are determined in accordance with the ideal weight of the pa-
tient:
IBW, kg Pi, cmH2O Ti, s RB, 1/min Minimum target frequency, 1/min
3-5 15 0.4 30 15
6-8 15 0.6 25 12
9 - 11 15 0.6 20 10
12 - 14 15 0.7 20 10
15 - 20 15 0.8 20 10
21 - 23 15 0.9 15 7
24 - 29 15 1 15 7
30 - 39 15 1 14 7
40 - 59 15 1 12 6
60 - 89 15 1 10 5
90 - 99 18 1.5 10 5
> 100 20 1.5 10 5
Regardless of the type of breath (hardware, synchronized hardware or supporting), the average
value of compliance as well as the average RCe value for the Otis equation are calculated after
three breaths to correct hardware and supporting breaths with DC.
At the switching from another mode Pi/PS are saved if the initial pressure applied in the pre-
vious mode is not greatly deviated from the start value. This allows to make softer and more im-
perceptible transition for the patient and to reduce fluctuations in both Pi/PS and MV.

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

Appendix 1.10.9 Function of MV adaptation


The function of MV adaptation is a tool that allows the physician to choose the best respiratory
minute volume for a particular patient.
Initial respiratory minute volume (%MV = 100) is quite average value calculated for the healthy
person in the passive state and having an average metabolism. One can say that the calculated
value MV protects the patient, but it does not guarantee the development of hypo- or hyperven-
tilation, although extreme and rough deviations are mostly excluded.
Therefore the function of MV adaptation was introduced in the iSV mode. It is intended to clarify
(to increase) the value of target MV at the appearance of the spontaneous breathing.
In all cases function of MV adaptation is activated only manually by pressing "Adapt.MV" button
in the edit parameters bar (bottom line of the screen).
The essence of the function of MV adaptation lies in the automatic step-by-step increasing of
%MV at the development of tachypnea and automatically returning to its initial value that is set
by the physician at the absence of tachypnea.
At the termination of spontaneous breathing at the stage of adaptation, when the percentage of
MV is increased, the pattern is supported with hardware breaths calculated for the current (ac-
cumulated) %MV. At the further absence of spontaneous breaths the current %MV decreases to
the value %MV set by the physician with step of 5 %. Such decrement %MV prevents the sub-
sequent patient’s hyperventilation at the at short-time tachypnea.
When real minute volume is above 200 %, the further adaptation is not carried out. The pres-
sure PS is fixed at the level providing tidal volume calculated according to the Otis equation for
MV = 200 %.

Appendix 1.10.10 Pmin parameter


The Pmin parameter in the ISV mode allows the operator to set the minimum pressure for the
spontaneous breaths support. Device will not decrease the Psup below this value even if the
parameters of the patient's respiratory mechanics allow this. This parameter can be useful in
patients with unconfirmed breathing system that are on artificial ventilation due to other reasons
(cerebral insufficiency, necessity in sedation, hypercatabolism, etc.), because it allows the op-
erator to regulate the minute ventilation structure (respiratory rate and respiratory volume).

App.1-17
Appendix 1.11 Selection of ventilation modes at the patient's disturbance and cough

Appendix 1.11 Selection of ventilation modes at the patient's distur-


bance and cough
In the volume-controlled modes (CMV/VCV, SIMV/VC) and at patient’s cougth, the maximum
pressure Pmax alarm can be activated at the coincidence of the moments of inspiration and
cough:

P(t) cough
Pmax

t1

Figure App. 1.9 – Cough

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

APPENDIX 2 METHODS OF DETERMINING PARAMETERS


Appendix 2.1 Compliance and resistance
The compliance is a characteristic of compliance (extensibility) of broncho-pulmonary system of
the patient. Resistance parameter is a measure of patient’s airway and the endotracheal (tra-
cheostomy) tube resistance.
The static compliance and resistance (Cst and Rst) are measured in all modes of ventilation
having hardware breaths by special hardware test breath. The measurement period in the range
of 0 - 10 minutes is set by the user in [Menu] → [Ventilation parameters] → [Compl. meas pe-
riod]. If necessary the user can measure the value of compliance and resistance at any time by
pressing the Cst/Rst window in the indication area of monitoring parameters.
Hardware test breath differs from the usual inspiration at operation in any mode of ventilation
because of the presence of inspiratory plateau. Test breaths in the CMV/VCV and SIMV/VC
modes always have rectangular flow waveform. Test breaths in the modes CMV/PCV and
SIMV/PC can have a little pressure dip during the formation of the plateau. For any test breaths
inspiratory time will be increased to the 0.5 - 2.0 s (for the formation of the plateau).
The device has also a second method for calculating of the compliance and resistance - dynam-
ic, i.e. at every inspiration without a special test inspiration by solving a system of differential
equations connecting the pressure and flow of gas in the breathing circuit. In the device’s inter-
face, the parameters obtained by this method are named as C and R and are displayed in sepa-
rate block of measurement parameters. The values of the parameters C and R vary on every
respiratory cycle.
At C and R parameters obtaining, a modern mathematical method for calculating lung mechan-
ics called the LSF (least square fitting) is used. The LSF method is based on the analysis of the
mathematical model of the lungs mechanical activity in real time during the whole respiratory
cycle.
Leakage in the circuit, depending on its value, can cause significant error in the compliance and
resistance measurement.

Appendix 2.2 AutoPEEP


AutoPEEP occurs when the ventilator settings (frequency, volume and inspiratory time) does
not correspond to the patient’s capabilities. In this case the patient before the start of the new
inspiration does not have enough time to exhale the air of the previous breath. Accordingly, the
end expiratory pressure is higher than the specified by ventilator setting.
AutoPEEP measurement is realized only for inactive patients in the mandatory breath cycles.
Measurement is carried out by creating an expiration delay (expiration hold) by the command of
operator or periodically (after the time specified in software).
For measurement by the operator's command, select "autoPEEP" in any block through [Menu]
[Display settings] [Choose measured par.blocks]. To measure click on the autoPEEP block,
then the block will change color from white to blue (indicating the beginning of the measure-
ment), and after the end of inspiration, the measured value will be displayed on it. To re-
measure, press the autoPEEP block again.
For periodic measurement using graphical button “Monitoring” select RESP2 window, where
measured autoPEEP value will be displayed.

App.2-1
Appendix 2.3 Mean pressure in the circuit for the respiratory cycle (Pmean)

P(t)

autoPEEP

t1 t2 t3 t4

t1-t2 expiraiton time,t2-t3 expiration hold (time of autoPEEP measurement)


Figure App.2.1 – Increasing of pressure in the circuit at the closed expiration valve due to pa-
tient’s end of expiration
Expiratory phase t1-t2 is carried out normally without deviations. At the time of the end of the
exhalation, inspiratory and expiratory flows are stopped, expiration valve is closed and flow ge-
nerator is also stopped. If there is an excessive pressure in the lungs, the gas flows from the
lungs to the breathing circuit. Pressure equalization occurs in the circuit-lungs system. At the
moment when the pressure change in the circuit becomes equal or less than 0.5 cmH2O/s, but
no earlier than 0.5 s and not later than 3 seconds, the procedure ends and inspiration begins.

autoPEEP = P(t3) – P(t2)

Expiration hold in any case can not exceed 3 seconds.

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)

Appendix 2.4 Time constant of the respiratory tract (τexp, τinsp)


Time constant of the respiratory tract is the product of compliance and resistance:
t = С × R.
It is necessary to record the time constant on the inspiration and expiration because these val-
ues differ in different situations (τinsp in most cases exceeds τexp). Thre difference is especially
expressed at the broncho-obstructive syndrome. Therefore the device calculates both parame-
ters for correct selection of inspiration and expiratory time.
Cst and Rinsp values are measured in the respiratory cycle with inspiration pause. In order to
minimize the error in the calculation of PEEP, in cases of significant decrease of compliance
and increased aerodynamic resistance (respiratory distress syndrome, edema of lungs, bron-
chial obstruction and so on) expiration is divided to 2 phases - fast and slow at the calculation of
τexp, because t of different areas of lungs can significantly differ. Fast one is associated mainly
with the gas flow from the breathing circuit. The slow one is related mainly with the gas flow
from the broncho-pulmonary tract. The ventilator detects τexp for slow expiratory phase. To elim-
inate the distortion of the result by the expiration part from the breathing circuit (fast phase), the
first 50 ms of expiratory phase are not included in the analysis.

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.

Appendix 2.5 Work of breathing (WOB)


The device calculates the work of breathing per 1 liter of tidal volume. This parameter can be
calculated by the algorithm in 2 versions: the work of spontaneous breathing of the patient at-
tempts Wspont (important indicator in deciding to terminate the ventilation) and the work of
breathing of device and patient Wvent (can be used to monitor the adequacy of the device’s
participation at the auxiliary ventilation).
WOB is calculated according to the formula:
t2
1
Vinsp t∫1
W= ∆P(t) ⋅ F(t) ⋅dt,

App.2-4
Appendix 2.6 Rapid shallow breathing index (RSBI)

where: t1 – beginning of the next inspiration,


t2 – end of the next inspiration,
∆P(t) – pressure change in the circuit at the inspiration, ∆P(t) = P(t)-PEEP,
F(t) – flow,
Vinsp – inspiration volume.
At the calculation of the work of breathing, the PEEP value is not considered as it does not
create extra work. However the high PEEP value may increase the work of breathing, because
it may reduce the compliance. Presence of autoPEEP always leads to increased work of breath-
ing.
The work of breathing is calculated in any mode at selecting of this option by the user. Calcula-
tion of the WOB is made on each inspiration. The ventilator displays the measured value and
the long-term trend of this parameter.

Appendix 2.6 Rapid shallow breathing index (RSBI)


Rapid shallow breathing index is also known as SBI. RSBI index indicates the adequacy of
spontaneous ventilation under the spontaneous breathing support (CPAP+PS, BiSTEP, APRV).
The device calculates the RSBI index in accordance with the following formula:
RSBI = fspont / τexp,
where fspont - frequency of spontaneous breaths,
τexp – time constant of the respiratory tract at the expiration.
Calculation of the RSBI is performed only at spontaneous inspiration in CPAP+PS, BiSTEP,
APRV modes. Measurement of texp is made at the each exhalation and is averaged for the last
4 cycles.

Appendix 2.7 Stress index (SI)


The device uses a graphical method for finding the stress index SI.
The idea of the stress index was suggested by Ranieri2 in 2000. Stress index is an integral indi-
cator of the correct choice of PEEP and inspiratory volume Vt. In accordance with the definition
Ranieri, stress index can be measured only for mandatory inspiraitons with a rectangular flow
waveform - in CMV/VCV and SIMV/VC modes.
Stress index is calculated as the factor of deviation of P(t) waveform from the triangular curve
(at the constant flow).
Range of allowable values of SI is from 0.1 to 2.0 with step of 0.01.
Case I: Correct PEEP and Vt values, SI is in the range from 0.9 to 1.1.
Case II: Low PEEP value, SI < 0.8.
Case III: Excessive PEEP of Vt value, SI > 1.1.

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)

P(t) P(t) P(t)

I II III

F(t) SI=1.0 F(t) SI=0.8 F(t) SI=1.4

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)

Running of the function


The P0.1 value is measured by the device P0.1 only for the spontaneous breaths in SIMV,
CPAP+PS, BiSTEP, APRV modes. P0.1 measurement is not performed if the leakage compen-
sation is enabled due to the impossibility of occlusal circuit creating. P0.1 measurement is inter-
rupted at the sanitiation support and mandatory breath. Lung recruitment maneuver does not ef-
fect to the P0.1 measurement. P0.1 measurement is initiated by activating of the RESP2 win-
dow. Measuring of P0.1 is made automatically 1 time in 1 minute.
In the classical method P0.1 value is measured at the closed inspiratory and expiratory
branches of the patient’s circuit:
P0.1 = P(t100) - P(t0)
Many studies have shown that the patient feels occlusion of the circuit if the occlusion time ex-
ceeds 0.15 seconds. He begins to worry that affects the measurement process. 0.1 seconds is
a compromise for both physicians and patients.
The following procedure is used in the device:

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)

Appendix 2.9 Ideal body weight of the patient (IBW)


The concept of the ideal body weight
IBW is an average function of the height and sex and does not depend on the actual weight of
the patient. It is used to determine the target MV, tidal volume and respiratory rate. The concept
of ideal weight has the important physiological significance - people of different weights, but the
same height have statistically similar size of lungs. Optimal inspiration volume better correlates
with height than with the weight.

Calculation of IBW for the adult patients


IBW in kg for men and women with the height from 130 to 250 cm:
For man: IBW = 0.908×height (cm) – 88.022
For woman: IBW = 0.905×height (cm) – 92.006
Alternative calculation published in the international website ARDS.net:
For man: IBW = 50+2.3×(height (in) – 60);
For woman: IBW = 45.5+2.3×(height (in) – 60);
where height – height in inches.
In both cases the results of the ideal body weight calculation are almost identical.

Calculation of IBW for the children


Calculation of IBW for children is a bit more complicated, because there is a nonlinear depen-
dence between the weight and the height. For pediatric mode centile WHO (World Health Or-
ganization) tables compiled on the basis of multi-center studies conducted in many countries
are used. Brief description of tables is as follows. Measurements of weight and height in child-
ren of the same age are performed, and research results are divided into a number of "corri-
dors" or percentiles. The maximum incidence (75 %) corresponds to the average corridor or
50th percentile, which can be considered as the ideal weight. The remaining 4 corridors are dis-
tributed according to the degree of deviation. The last match corridors correspond to the inci-
dence of 3 %. Girls and boys have small differences in the height-weight ratio.

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)

59 5.7 5.6 100 15.2 15.0


60 6.0 5.9 101 15.4 15.3
61 6.3 6.1 102 15.7 15.6
62 6.5 6.4 103 16.0 15.9
63 6.8 6.6 104 16.3 16.2
64 7.0 6.9 105 16.6 16.5
65 7.3 7.1 106 16.9 16.9
66 7.5 7.3 107 17.3 17.2
67 7.7 7.5 108 17.6 17.6
68 8.0 7.7 109 17.9 18.0
69 8.2 8.0 110 18.3 18.3
70 8.4 8.2 111 18.9 19.0
71 8.6 8.4 112 19.2 19.4
72 8.9 8.6 113 19.6 19.8
73 9.1 8.8 114 20.0 20.2
74 9.3 9.0 115 20.4 20.7
75 9.5 9.1 116 20.8 21.1
76 9.7 9.3 117 21.2 21.5
77 9.9 9.5 118 21.6 22.0
78 10.1 9.7 119 22.0 22.4
79 10.3 9.9 120 22.4 23.4
80 10.4 10.1 122 25.0 23.4
81 10.6 10.3 124 26.0 24.0
82 10.8 10.5 126 27.0 24.7
83 11.0 10.7 128 28.0 25.3
84 11.3 11.0 130 30.0 26.0
85 11.5 11.2

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)

For your notes

App.2-10
Appendix 3 Electromagnetic environment

APPENDIX 3 ELECTROMAGNETIC ENVIRONMENT


The ventilator is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.

Guidance and manufacturer’s declaration – electromagnetic emissions


Emissions test Compliance Electromagnetic environment – guidance
The ventilator uses RF energy only for its in-
RF emissions ternal function. Therefore, its RF emissions
Group 1
CISPR 11:2009 are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
Class A
CISPR 11:2009 The ventilator is suitable for use in all estab-
Harmonic emissions lishments other than domestic and those di-
Class A rectly connected to the public low-voltage
IEC 61000-3-2:2009 power supply network that supplies buildings
Voltage fluctuations/flicker emissions used for domestic purposes.
Complies
IEC 61000-3-3:2008

Guidance and manufacturer’s declaration – electromagnetic immunity


Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment – guidance
Floors should be wood, con-
Electrostatic crete or ceramic tile. If floors
± 6 kV contact; ± 6 kV contact;
discharge (ESD) are covered with synthetic ma-
± 8 kV air ± 8 kV air terial, the relative humidity
IEC 61000-4-2:2008
should be at least 30 %.
± 2 kV for power supply ± 2 kV for power
Electrical fast Mains power quality should be
lines; supply lines;
transient/burst that of a typical commercial or
± 1 kV for input/output ± 1 kV for input/ hospital environment.
IEC 61000-4-4:2012 lines output lines

± 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

Radiated RF 3 V/m 3 V/m d = 1.2 P


IEC 61000-4-3:2008 80 MHz to 2.5 GHz
(80 to 800 MHz);
d = 2.3 P
(800 MHz to 2.5 GHz),
where P is the maximum out-
put power rating of the
transmitter in watts (W) accord-
ing to the transmitter
manufacturer and d is the rec-
ommended separation dis-
tance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site sur-
a
vey, should be less than the
compliance level in each
b
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

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

Recommended separation distances between portable and mobile RF communications


equipment and the ventilator
The ventilator is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ventilator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the ventilator as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter, m
150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
Rated maximum MHz outside MHz in ISM MHz GHz
output power of ISM bands bands
transmitter, W

d = 1.2 P d = 1.2 P d = 1.2 P d = 2.3 P


0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.73

1 1.20 1.20 1.20 2.30

10 3.80 3.80 3.80 7.27

100 12.00 12.00 12.00 23.00


For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1. At 80 MHz and 800 MHz, the separation distance for 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.

App.3-3
Appendix 3 Electromagnetic environment

For your notes

App.3-4
Appendix 4 Pneumatic scheme of ventilator

APPENDIX 4 PNEUMATIC SCHEME OF VENTILATOR

App.4-1
Appendix 4 Pneumatic scheme of ventilator

For your notes

App.4-2
Appendix 5 Technical malfunction and events

APPENDIX 5 TECHNICAL MALFUNCTION AND EVENTS


At the unsuccessful starting tests or at the transition into emergency mode of ventilation the de-
vice displays error codes for the particular modules:
• CIVL – ventilation controller
• CIND – display controller
• PU – power unit
• GM – gas mixer circuit
• PR.CONV. – protocol converter circuit (mainstream capnometer)
• SpO2 – pulse oximetry module

Appendix 5.1 Technical malfunction


If a technical malfunction occurs, the ventilation can be temporary continued with the par-
tial loss of functionality. When the device is turned on again, a switching to a technical failure
occurs, see it. 4.17.6. Further operation of the device is not possible, see it. 4.17.6. Contact ser-
vice department.
A detailed description of the malfunction and an indication of the unit in which the malfunction
occurred are given in Table App 5.1. This information is to be reported to the service depart-
ment.
Table App. 5.1 Technical malfunction messages

No Alarm message Alarm conditions Module


1. Technical malfunction 1
There is no communication with the gas mixer CIVL
(Tech.malf.1)
2. Technical malfunction 2
The expiration valve malfunction occurred. CIVL
(Tech.malf.. 2)
3. Technical malfunction 3
The purge compressor malfunction occurred. CIVL
(Tech.malf.. 3)
4. Technical malfunction 4
The flow generator malfunction occurred CIVL
(Tech.malf.. 4)
5. Technical malfunction 5 There is no communication with the ventilation
CIND
(Tech.malf.. 5) controller
6. Technical malfunction 6
There is no communication with the power unit CIND
(Tech.malf.. 6)
7. Technical malfunction 7
Safety valve malfunction occurred. CIVL
(Tech.malf.. 7)

App.5-1
Appendix 5 Technical malfunction and events

Appendix 5.2 Technical messages


Technical messages are intended to inform the operator about events in the device and do not
require immediate action from the operator. Technical messages are intended for service per-
sonnel. A detailed description of the technical messages and an indication of the unit in which
the malfunction occurred are given in Table App 5.2.
Table App. 5.2 Technical malfunction messages

No Alarm message Alarm conditions Module


1 Technical Message 1
CIND restart type R CIND
(Tech. msg..1)
2 Technical Message 2
CIND restart type F CIND
(Tech. msg..2)

App.5-2
Appendix 6 DELIVERY SET

APPENDIX 6 DELIVERY SET


Name Part number Quantity, items

TESM.941144.001-01 Triton Electron-


1 Intensive Care Ventilator MV200 1
ic Systems Ltd, Russian Federation
including:
TESM.230001 Triton Electronic Sys-
1.1 electronic unit 1
tems Ltd, Russian Federation
TESM.186143 Triton Electronic Sys-
1.2 filter-regulator 1
tems Ltd, Russian Federation
TESM.186307-01 Triton Electronic
1.3 mobile trolley 1
Systems Ltd, Russian Federation
TESM.046002-01 Triton Electronic
1.4 high pressure oxygen hose 1
Systems Ltd, Russian Federation
TESM.189015 Triton Electronic Sys-
1.5 arm for the patient circuit 1
tems Ltd, Russian Federation
TESM.189014 Triton Electronic Sys-
1.6 basket by special order
tems Ltd, Russian Federation
VH-2000 VADI Medical Technology
Co. Ltd, Taiwan
MR810 Fisher & Paykel Healthcare
1.7 humidifier by special order
Ltd, New Zealand
MR850 Bundle Fisher & Paykel
Healthcare Ltd, New Zealand
G-314002 VADI Medical Technology
by special order
Co., Ltd., Taiwan
1.8 humidifier chamber
MR370 Fisher & Paykel, New Zealand
038-01-155B Flexicare Medical Ltd,
UK 1
1.9 patient circuit, disposable, adult
5009 Intersurgical Ltd, UK
RT206 Fisher & Paykel Healthcare
Ltd, New Zealand
1.10 patient circuit, disposable, adult by special order
038-31-768 Flexicare Medical Ltd, UK

RT105 Fisher & Paykel Healthcare


Ltd, New Zealand
1.11 patient circuit, disposable, adult by special order
038-01-163 Flexicare Medical Ltd, UK
900МR784 Fisher & Paykel Health-
1.12 patient circuit, reusable, adult by special order
care Ltd, New Zealand
038-02-155B Flexicare Medical Ltd,
patient circuit, disposable, pedia- UK 1
1.13
tric
5513 Intersurgical Ltd, UK
4504810 Intersurgical Ltd, UK
patient circuit, disposable, pedia-
1.14 by special order
tric 5504810 Intersurgical Ltd, UK

App.6-1
Appendix 6 DELIVERY SET

Name Part number Quantity, items

038-03-315 Flexicare Medical Ltd, UK


1.15 patient circuit, disposable, neo-
by special order
natal
4510 Intersurgical Ltd, UK
RT225 Fisher & Paykel Healthcare
1.16 patient circuit, disposable, neo- Ltd, New Zealand
by special order
natal 038-03-340С Flexicare Medical Ltd,
UK
patient circuit, reusable, adult / KD-“MS-1” Medsilicon Ltd, Russian
1.17 by special order
pediatric Federation

1944 Intersurgical Ltd, UK


1.18 filter bacterial, adult, disposable 1
038-41-365 Flexicare Medical Ltd, UK

1644 Intersurgical Ltd, UK


filter bacterial, pediatric,
1.19 by special order
disposable
038-42-365 Flexicare Medical Ltd, UK

Filta-Therm 1942 Intersurgical Ltd, UK


1.20 HME filter, adult, disposable 1
038-41-355 Flexicare Medical Ltd, UK

Filta-Therm 1641 Intersurgical Ltd, UK


1.21 HME filter, pediatric, disposable by special order
038-42-355 Flexicare Medical Ltd, UK

010-740 Flexicare Medical Limited,


UK
1.22 hydrophobic filter by special order
REF 2715 Intersurgical Ltd, UK
0.5 L 038-83-805NL Flexicare Medical
Limited, UK
1.23 breathing bag by special order
0.5 L 2805 Intersurgical Ltd, UK

3 L 2830-00 S Intersurgical Ltd, UK


1.24
breathing bag 1
3 L 038-81-830NL Flexicare Medical
Limited, UK
15M-22M/15 REF2714 Intersurgical
Ltd, UK
1.25 connector by special order
15М-22М/15 010-641 Flexicare Medi-
cal Limited, UK
22F-22F REF1967, Intersurgical Ltd,
1.26 connector by special order
UK
mainstream CO2 module, includ-
ing: TESM.506001 Triton Electronic Sys-
1.27 mainstream CO2 sensor tems Ltd, Russian Federation by special order
airway adapter, reusable, TESM.706020 Triton Electronic Sys-
adult/pediatric tems Ltd, Russian Federation

App.6-2
Appendix 6 DELIVERY SET

Name Part number Quantity, items

airway adapter, reusable, pedia- TESM.706021 Triton Electronic Sys-


tric/neonatal tems Ltd, Russian Federation
032-10-005 Flexicare Medical Ltd, UK
1.28 nebulizer pneumatic 1
Cirrus REF 2605 Intersurgical Ltd, UK

1.29 nebulizer Aeroneb Aerogen Ltd, Ireland by special order

NovaStar, size L Draeger, Germany


1.30 mask by special order
Full Face, size L BMC Medical, China

NovaStar, size S Draeger, Germany


1.31 mask by special order
Full Face, size S BMC Medical, China

NovaStar, size M Draeger, Germany


1.32 mask by special order
Full Face, size M BMC Medical, China

FaceFit REF2250 Intersurgical Ltd,


UK
1.33 mask for NIV by special order
FaceFit REF2255 Intersurgical Ltd,
UK
FaceFit REF2251 Intersurgical Ltd,
1.34 mask for NIV by special order
UK
FaceFit REF2252 Intersurgical Ltd,
1.35 mask for NIV by special order
UK
NIV431 Fisher & Paykel Healthcare
1.36 mask by special order
Ltd, New Zealand
G-322011 VADI Medical Technology
1.37 flex tube by special order
Co., Ltd., Taiwan
2 m 010-700 Flexicare Medical Li-
mited, UK
1.38 gas monitoring line by special order
2.45 m REF2732 Intersurgical Ltd, UK

1.39 nut М6-6Н.5.016 GOST 3032-76 1

pulse oximetry sensor, reusable, RM.501.00.124-01 Triton Electronic


1.40 by special order
clip, adult Systems Ltd, Russian Federation
pulse oximetry sensor, reusable, RM.501.00.004-01 Triton Electronic
1.41 by special order
wrap, neonatal Systems Ltd, Russian Federation
pulse oximetry sensor, reusable, RM.501.00.124-01 Triton Electronic
1.42 by special order
clip, adult Systems Ltd, Russian Federation
Adult esophageal balloon catheter REF 47-9005, CooperSurgical, Inc.,
1.43 set USA by special order
Multifunction nasogastric catheter NutriVent REF09031015, SIDAM s.r.l.,
1.44 Italy by special order

App.6-3
Appendix 6 DELIVERY SET

Name Part number Quantity, items

Catheter TESM.046502 Triton Electronic Sys-


1.45 tems Ltd, Russian Federation by special order

2 Spare parts:

T2.0AL/250V Radiodetal, Russian


2.1 fuse 2
Federation
TESM.189017 Triton Electronic Sys-
2.2 microfilter 1
tems Ltd, Russian Federation
TESM.236501 Triton Electronic Sys-
2.3 membrane 1
tems Ltd, Russian Federation
TESM.009926 Triton Electronic Sys-
2.4 dust filter 2
tems Ltd, Russian Federation
60-13100-00 Dryline Water Trap, Adu-
2.5 water trap by special order
lit ARTEMA, Sweden
TESM.049124 Triton Electronic Sys-
2.6 ring 2
tems Ltd, Russian Federation
3 Accompanying documents:

3.1 User manual TESM.941144.001-01 UM 1

4 Transport package TESM.233003 1

App.6-4
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS

APPENDIX 7 ADDITIONAL PARAMETERS AND CHARACTE-


RISTICS
No Parameter Value (description)

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

No Parameter Value (description)

1.19. Response delay of the expiration valve up to 5 ms


1.20. Maximum (peak) flow on inspiration 180 lpm
1.21. Nebulizer turning on automatic indication Available
Automatic leakage compensation during invasive venti-
1.22. Available
lation
Automatic leakage compensation during noninvasive
1.23. Available
ventilation
2. Built-in functions
2.1. Oxygenation Enabling 100% FiO2 for 2 minutes

Stop ventilation on personnel demand, the


2.2. Standby mode
device goes into standby mode

The transient increasing of PEEP to the


2.3. Alveolar recruitment maneuver
specified level
Automatic detection of disconnection and
connection of the circuit with oxygenation
2.4. Suction
before disconnecting and after connecting of
the circuit
The device automatically compensates lea-
kage in the circuit in all modes of ventilation.
2.5. Leak compensation If the leakage is too large and can not be
compensated, circuit disconnection alarm is
triggered.
Immediate breath by the operator’ com-
2.6. Manual breath (manual ventilation) mand, if necessary clinician may perform
breaths with the desired frequency
Stopping of the graphs for the analysis of in-
2.7. "Freezing" / analysis of graphs
stantaneous values
Protects the device from unintended modifi-
2.8. Screen lock
cation of the ventilation modes
Changing the brightness of the screen in
2.9. Display brightness control
day and night mode
3. Ventilation parameters
Rate of the pressure rise (inspiration pressure increase
3.1. 5 - 200 cmH2O/s
phase), Pramp
3.2. Plateau time, Tplat 0 - 70 % from inspiratory time
3.3. Trigger window, TrigWnd 0-60 s
Criterion of spontaneous inspiration volume exceeding
3.4. Available
of 25ml
3.5. Flow acceleration, Facc 10 - 100 %
3.6. Support flow (base flow), Fsupp 0 - 30 lpm
3.7. “Open valve” function Available
Factor of increasing/decreasing of target MV in the iSV
3.8. 25 - 300 %
mode, %MV
3.9. Function of MV adaptation it the iSV mode, Adapt.MV Available
Limiting pressure in the breathing circuit in iSV mode,
3.10. 0 - 72 cmH2O (mbar)
Plimit
Minimum support pressure of spontaneous
3.11. 3 - 50 cmH2O (mbar)
breaths,Pmin

App.7-2
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS

No Parameter Value (description)

3.12. Endotracheal tube compensation, ETC 0 - 100 %


4. Respiratory monitoring parameters
4.1. Mean pressure for the respiratory cycle Pm
4.2. Residual pressure level in lungs AutoPEEP
4.3. Minute volume of spontaneous breaths MVspont
4.4. Frequency of spontaneous breaths fspont
4.5. Dynamic compliance/ resistance C, R (LSF)
4.6. Peak inspiratory flow FlowPeak
4.7. Leakage flow from the breathing circuit Leak
4.8. Plateau pressure Pplat
4.9. Elimination of СО2 per minute (option) VCO2
4.10. Minute alveolar ventilation, alveolar ventilation (option) MValv, Valv
4.11. Functional dead space (option) Vd
4.12. Cardiac output according to Fick (option) СO
Auxiliary external pressure (option) Paux
4.13.
Transpulmonary pressure (option) Ptp
5. Extended respiratory monitoring (RESP2 window)
True pressure level in lungs at the end of expiration
(pressure in the lungs by the end of exhalation taking in-
5.1. PEEPtot
to account the incomplete expiratory PEEtot = PEEP +
AutoPEEP)
Residual pressure level in lungs (that occurs due to the
5.2. AutoPEEP
incompleteness of exhalation)
Flow at the end of expiration (residual gas flow from the
5.3. ExpEndFlow
lungs arising from incomplete exhalation)
Expiratory time constant (time constant that determines
5.4. the potential rate of pressure change in the lungs during RCexp
expiration τexp = Rexp × Cexp)
Inspiratory time constant (time constant that determines
5.5. the potential rate of pressure change in the lungs during RCinsp
inspiration τinsp = Rinsp × Cinsp)
Stress index. The coefficient describes the adequacy of
PEEP and Vt selection. Can be defined in the
5.6. SI
CMV/VCV and SIMV/VC modes for hardware breaths at
the rectangular waveform.
Respiratory effort index. Parameter characterizes the
5.7. strength of the patient's breathing attempts. Measured P0.1
in cmH2O
Work of the patient breathing. Parameter characterizes
5.8. the work of breathing of the patient based on 1 liter of Wspont
tidal volume
Work of the ventilator breathing. Parameter characteriz-
5.9. es the work of breathing of the ventilator based on 1 liter Wvent
of tidal volume
6. Extended respiratory monitoring (RESP 3 window)
Inspiratory time, including spontaneous (time of the last
6.1. Tinsp
inspiration, made by ventilator or patient)
Factor of breathing cycle filling (ratio of inspiratory time
6.2. Tinsp/Ttot
to total respiratory cycle time)

App.7-3
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS

No Parameter Value (description)

Factor of spontaneous breathing (ratio of the minute vo-


6.3. lume of spontaneous breathing to the total breathing vo- MVe_sp / MVe
lume)
Resistance to the exhalation (total airway resistance
6.4. Rexp
during exhalation)
Elasticity of respiratory ways (elastence). Parameter is
6.5. reverse to the static compliance. Measured in E
mmН2О/ml.
Resistance of the breathing circuit, measured in the cir-
6.6. Rcirc
cuit test
Compliance of the breathing circuit, measured in the
6.7. Ccirc
circuit test
6.8. Compliance Cdyn
Rapid shallow breathing index (dimensionless parame-
6.9. RSBI
ter characterizing the depth of patient’s breathing)
7. Graphical monitoring
Number of curves simultaneously displayed on the
7.1. 1, 2, 3 or 4 selected by the user
screen
Simultaneous display of 3 curves and 1 loop
at the user's choice. Ability to save ("freeze")
7.2. Displaying of spirometry loops the reference loop and to the store the mo-
ment of saving. Analysis of the main para-
meters of the respiratory cycle.
• Paw (pressure);
• Flow (flow);
• Vol (volume);
• Loops:
- volume/flow V-F,
- volume/pressure V-P,
- flow/pressure F-P,
Optional:
Graphs (spirometric curves) with automatic scaling of • PCО2 (capnogram in mmHg);
7.3.
the amplitude versus time • PCO2 (capnogram in%);
• РO2 (oxigram in %);
• SpO2 (photoplethysmogram);
• graph of iSV mode;
• VCO2 (volume capnogram);
• Рaux (external auxiliary pressure) with
Paw – Paux curve;
V/Paux (volume/auxiliary external pressure
curve)
• Icon at the beginning of the spontaneous
breath
• Highlighting of the graph contour Paw in
7.4. Displaying of the respiratory activity of the patient
phase of spontaneous breaths
• Marker at the start of spontaneous inspi-
ration

7.5. Selection of the type of spirometry loops Selection of one of three possible loops

Scaling curves The vertical scale of the pressure curve in


7.6. - pressure waveform in the range -20…120 cmH2O the airways user chooses using Pmax pa-
(mbar) rameter. The other curves are scaled auto-

App.7-4
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS

No Parameter Value (description)


- flow waveform in the range -250…250 lpm matically. The horizontal scale of the curve
is set automatically when user switch the
child / adult mode or manually select scan-
ning speed from "1, 2, 4".
"Freezing" of graphic curves and review with
7.7. Mode of freezing and analysis of the graphical curves the cursor of the instantaneous values of
flow, volume, pressure, time
According to the user’s selection space un-
Displaying of the graphic curves in the contour or filling
7.8. der the curve can be filled for the better con-
form
trast
Inspiratory phase is highlighted with blue
color for the hardware breath and white color
Identification of phases and type of the respiratory
7.9. for the spontaneous breaths. In addition, the
cycle
start of spontaneous inspiration is marked
with vertical line.
8. Option modules and functions
Provides the evaluation of CO2 concentra-
tion (partial pressure) directly in the patient
8.1. Mainstream capnometer (external)
tee (main stream) in the range of 0 - 15 %
(0 - 115 mmHg)
Provides the evaluation of:
• amount of carbon dioxide exhaled by the
patient VCO2;
8.2. Function of volume capnometry
• functional dead space Vd;
alveolar minute ventilation MValv, alveolar
ventilation Valv
Provides calculation and displaying of car-
Function of cardiac output calculation (in accordance diac output by A.Fick
8.3.
with A. Fick method)

Provides the evaluation of:
• oxygen saturation of arterial hemoglobin
SpO2 in the range of 60 - 100 %;
peripheral pulse rate PR in the range of 15 -
8.4. Pulse oximetry module 320 1/min
SpO2 measurement accuracy:
- in the range of 90 - 100 % ±2 % abs
- in the range of 60 - 89 % ±3 % abs
Data update period: 20 ms
Provides the evaluation of:
• oxygen consumption VO2;
• carbon dioxide elimination VCO2;
8.5. Module of metabolism (indirect calorimeter)
• respiratory quotient RQ;
resting energy expenditure of the patient
REE
• Provides calculation of airway pressure
Function of the endotracheal tube resistance compen-
8.6. taking into account the resistance of the en-
sation
dotracheal tube
Provides the measuring of the pressure
Paux in the trachea or the esophagus using
8.7. “Auxiliary external pressure” function a catheter with displaying of Paux and Paw-
Paux curves and the calculation of the
transpulmonary pressure Ptp
The interface for connection to the personal computer Transmitted data: graphic curves, ventilation
8.8.
(Ethernet connector on the rear panel). parameters, monitoring parameters.

App.7-5
Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS

No Parameter Value (description)


Transmitted data: screenshot (current status
Interface for connecting USB flash memory device of the screen), the alarm log, the service log,
(USB connector on the rear panel). selected segment of trend.

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

Acc.charge The residual capacity of the accumulator (in %).

Adapt.MV Function of MV adaptation in the iSV mode

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.

APRV Airway pressure release ventilation mode. It is an extension of the CPAP+PS


mode. The patient in this mode breathes independently with the help of a
pressure support level.
ATP Type of flow correction on inspiration and expiration. Ambient Temperature,
Pressure – conversion is carried out for the relative humidity of 30% and am-
bient temperature of 25 °C.
ATPD Type of flow correction on inspiration and expiration. Ambient Temperature,
Pressure, Dried – ambient temperature and pressure with humidity 0 %; this
correction is similar to ATP at 0% relative humidity.

ATPS Type of flow correction on inspiration and expiration. Ambient Temperature,


Pressure, Saturated – ambient temperature and pressure with humidity 100
%, this correction is similar to ATP at 100% relative humidity.
AutoPEEP Residual pressure in lungs that occurs due to the incompleteness of expira-
tion.
BiSTEP Spontaneous breathing with two levels of continuous positive airway pressure
with pressure support of spontaneous breaths. The patient can breathe
through the device in both phases of the pressure in the circuit. The transition
from the low-pressure phase to the high one is the inspiration with pressure
control, the transition from the high-pressure phase is the expiration. Howev-
er, unlike the PCV mode, inspiration and expiration can be separated by a
significant time interval during that the patient breathes spontaneously. The
device calculates separately the volumes of ventilator’s and spontaneous
breathing.
Breathing circuit calibra- Intended to adapt the device to the breathing circuit (see it. 4.16.6).
tion
BTPS Type of flow correction on inspiration and expiration. Body Temperature,
Pressure, Saturated, with 100 % humidity.
C (LSF) Indicator of lungs compliance. It is measured dynamically by solving a system
Cdyn of equations connecting the pressure and flow of gas in the breathing circuit.
The measurement is carried out during the inspiratory phase in the current
respiratory cycle.

Gl-1
GLOSSARY

CAPN MS Mainstream capnometer (service menu message).

CAPNO Symbol of CO2 measurement (capnography)


Capnogram Graphical representation of the instantaneous carbon dioxide concentration.
Cardiac output according See CO.
to Fick equation
Ccirc Compliance of the breathing circuit, measured at the short internal test.
CIND Indication controller. Part of the device’s hardware and software responsible
for displaying and parameterization.
CIVL Ventilation controller. Part of the device’s hardware and software responsible
for patient’s ventilation.
CMS 1) Centralized monitoring system.
2) Naming of the network card in the service menu.
CMV/PCV Controlled Mandatory Ventilation / Pressure Control Ventilation.
Controlled mandatory ventilation with pressure control. In this mode inspiration
is provided at with the set pressure, respiratory rate and inspiratory time.
The pressure value is set by Pi parameter delivered above PEEP and firmly
guaranteed during inspiration.
CMV/VCV Controlled Mandatory Ventilation / Volume Control Ventilation.
Controlled mandatory ventilation with volume control. In this mode the patient
receives the set tidal volume. The shape of the flow curve is rectangular or de-
creasing, at the physician's choice.
CO Cardiac output according to Fick equation. Indirect method of assessing cardiac
output by oxygen consumption estimation.
Compl. meas.period Compliance measurement period. Defines the time between the cycles of com-
pliance and resistance measurements.
Compliance See C
Compliance of the See Ccirc
breathing circuit
CPAP+PS Constant Positive Airway Pressure. The ventilation mode supporting spontane-
ous breathing with the set positive airway pressure. The device supports the
spontaneous inspiration attempt with pressure (PS). The criterion for starting
the inspiration support cycle is the inspiratory trigger (flow or pressure).
Cst Static compliance. Indicator of lungs compliance. Measured by creating a
pause on inspiration (inspiratory pause).
E Elastance (elasticity of respiratory ways). Reverse value of static compliance.
Measured in mmH2O, in CMV, SIMV, PCV-VG modes.
Elasticity of respiratory See Е
ways (elastance)
Elimination of СО2 per The difference between the CO2 concentration of in the exhaled and inhaled
minute mixture.
ETC Endotracheal tube compensation. Ventilation parameter.
EtCO2 Concentration (partial pressure) of СО2 in the exhaled mixture.
ETS Expiration trigger sensitivity. Ventilation parameter.
ExpEndFlow Flow at the end of expiration (residual gas flow from lungs caused by the in-
com-pleteness of expiration), lpm. Displayed in RESP 2 window.
Expiration trigger sensi- Expiration trigger sensitivity - percentage of peak inspiratory flow at which the
tivity (ETS) device switches from inspiration to expiration in the respiratory cycle with pres-
sure support.
Expiratory time constant See τexp
Gl-2
GLOSSARY

Expiratory volume See Vexp


Facc Flow acceleration. Ventilation parameter.
Factor of breathing cycle See Tinsp/Ttot
filling
Factor of spontaneous Ratio of the minute volume of spontaneous breathing to the total breathing vo-
breathing lume. Calculated as: MVe_sp / MVe
FEM Full emergency mode. See it. 4.17.5 Description of emergency mode
FiCO2 Concentration (partial pressure) of CO2 in the inspired mixture. Displayed in
any of the fields of the screen.
FiO2 Fractional concentration of inspired oxygen. Displayed in any of the fields of the
screen.
Oxygen consumption (difference between oxygen concentration in the inhaled
FiO2-EtO2
and exhaled mixture), for the metabolism measurement module.
Flow Flow waveform (graph).
Flow at the end of expira- See ExpEndFlow.
tion
Flow graph See Flow
FlowPeak Peak inspiratory flow. Displayed in separate window of measured parameters
block.
FormFlow Flow waveform
Fspont Frequency of spontaneous breaths
Fsupp Support flow.
Ftrig Flow trigger sensitivity (operation threshold)
Functional dead space See Vd. The default value is calculated as a function of the patient's growth.

Gas mixer See GM.


Gas mixture Gas entering the patient: environmental air enriched with oxygen, warmed and
moistened. At operation of nebulizer - with medications.
GM Gas mixer. Part of the hardware responsible for mixing of external air and oxy-
gen inside the ventilator.
Humidifier Device for increasing the humidity of the respiratory mixture.
I:E Inspiratory:expiratory ratio
Indication controller See CIND
Inspiratory pause The final interval of inspiratory time when the pressure is fixed and there is no
air flow to the patient.
Inspiratory time See Tinsp.
Inspiratory time constant See τinsp
Inspiratory volume See Vinsp
iSV Intellectual support ventilation
Leak Leakage, otherwise - the difference between the volume of inhaled and exhaled
air, loss of volume of the respiratory mixture in the system "ventilator-patient".
LSF Least square fitting. Modern mathematical method of computer calculating of
lung mechanics parameters.
Mainstream capnometry Measurement of the carbon dioxide concentration directly in the breathing cir-
cuit. All breathing gas passes through a special adapter.
Mean pressure for the See Pm.
respiratory cycle
Gl-3
GLOSSARY

Minute alveolar ventila- See MValv


tion
Minute volume See MV
MS Mainstream CO2 sensor (service menu message).
MV Minute volume (the sum of tidal volumes per minute).
MValv Minute alveolar ventilation.
MVe_sp / MVe Factor of spontaneous breathing.
MVexp Expiratory minute volume (volume eliminated from the patient)
MVspont Minute volume of spontaneous breaths.
NIV Non-invasive ventilation of lungs. The mode of spontaneous breathing with a
set positive pressure in the airways and set support of spontaneous breathing
through the face mask. The mode is very similar to CPAP+PS, the differences
are due to the inevitability of leakage in non-invasive ventilation.
Occlusion Blocking of patient’s expiration or inspiration. Can be caused by the action of
the ventilator or occlusion of the respiratory circuit.
Open Valve “Open valve” function. Reflects the current trend of maintaining and supporting
spontaneous breathing at all stages of ventilation. See it.4.21 “Open valve func-
tion”
Oxygen consumption See VO2
P0.1 Respiratory effort index. Index characterizes the strength of the patient's
breathing attempts. It is measured in cmH2O.
PaCO2 Arterial CO2 concentration obtained using one of the laboratory techniques
Paux Auxiliary external pressure.
Paw Airway pressure waveform (graph).
PCV-VG Mandatory ventilation with guaranteed delivery of target respiratory volume at
minimum possible pressure. Functionally mode repeats the CMV / PCV mode
with one exception: instead of the target pressure, the user sets the target in-
spiratory volume. The inspiratory pressure is corrected by the device with each
new inspiration according to the target volume.
PCО2 Capnogram (graph).
Peak inspiratory flow See FlowPeak
Peak inspiratory pres- See PIP
sure
PEEP Positive end-expiratory pressure
PEEPtot True pressure level in lungs at the end of expiration. Pressure in the lungs at
the end of expiration, taking into account the incomplete expiration
PEEPtot= PEEP + AutoPEEP. Displayed if both parameters are measured cor-
rectly.
Phigh Pressure value in the high pressure phase (in the BiSTEP, APRV modes).

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.

PR Peripheral pulse rate


PR.CONV. Protocol converter (service menu message).
Pramp Rate of the pressure rise. This value determines the time of reaching of the tar-
get pressure in the pressure control mode and at spontaneous inspiration sup-
port.
Pressure graph See Paw
PS Support pressure of spontaneous breath.
Ptp Transpulmonary pressure
Ptrig Pressure trigger sensitivity (operation threshold). See trigger.
PU Power unit (service menu message).
Pulse oximetry module Optional module that provides monitoring of oxygen saturation of arterial blood
hemoglobin SpO2, peripheral pulse rate PR, displaying of photoplethysmo-
gram.
PvCO2 Venous CO2 concentration obtained using one of the laboratory techniques
PО2 Oxigram for operation with metabolism measurement module (calculated as the
difference FiO2 - EtO2) (graph).
Qmax The maximum oxygen flow passed through the port.
R (LSF) Resistance (resistance of airways to the respiratory mixture flow). It is meas-
ured dynamically by solving a system of equations connecting the pressure and
flow of gas in the breathing circuit. The measurement is carried out during the
inspiratory phase in the current respiratory cycle.
Rapid shallow breathing See RSBI
index
RB Rate of breathing, respiratory rate (frequency of mandatory breaths).
RBapnea Respiratory rate in the apnea mode.
RCexp See τexp
RCinsp See τinsp
Rcirc Resistance of the breathing circuit measured during breathing circuit calibra-
tion.
REE Resting energy expenditure. Total energy consumption in rest, kkal/day.

REF Reference loop.


Reference loop See Ref.
Residual pressure level See AutoPEEP.
in lungs
Resistance See R, Rst.
Resistance of the breath- See Rcirc.
ing circuit
Gl-5
GLOSSARY

Resistance of the endo- One of the components of resistance.


tracheal tube
Resistance to the expira- See Rexp.
tion
Respiratory effort index See Р0.1.

Respiratory quotient See RQ.

Respiratory quotient See RQ.

Resting energy expendi- See REE.


ture
Rexp Resistance to the expiration. The total resistance of the airways during the expi-
ratory phase.
RQ Respiratory quotient.
RSBI Rapid shallow breathing index. The dimensionless quantity characterizing the
depth of patient’s breathing. Measured in CPAP+PS, BiSTEP, APRV modes.
See Appendix 2.6.
Rst Resistance (resistance of airways to the respiratory mixture flow). Measured by
creating a pause on inspiration (inspiratory pause).
Safety valve One of the elements of patient safety. In case of emergency occlusion of the
circuit, the device opens the safety valve and provides further ventilation with
the discharge of the exhaust air through this valve to the atmosphere until the
causes of occlusion are eliminated.
Sampling line Thin plastic tube for sampling of the respiratory mixture by the metabolism
measurement module (standard extension of infusion pumps).
SI Stress index. Index characterizes the correctness of PEEP and Vt selection. It
is determined in the CMV/VCV and SIMV/VC modes for hardware breaths at
the rectangular shape of the flow waveform.
Sigh Mode of the deepen sigh.
SIMV/DC Synchronized Intermittent Mandatory Ventilation / Double Control. Ventilation
mode, the analogue of the SIMV / PC except that the ventilator’s breath is per-
formed in a double-check mode similar to the PCV-VG.
SIMV/PC Synchronized Intermittent Mandatory Ventilation / Pressure Control.

SIMV/VC Synchronized Intermittent Mandatory Ventilation / Volume Control.


SpO2 Оxygen saturation of arterial blood hemoglobin.
Stress index See SI.
Support flow The respiratory mixture flowing through the circuit at the intervals of absence of
gas exchange between the ventilator and the patient, necessary to support
spontaneous inspiration.
Tapnea Time of transition to the apnea mode in case of the absence of ventilator’s and
spontaneous breathing. Controlled parameter.
Texp Expiratory time.
Thigh Time of the high pressure phase in the BiSTEP, APRV modes.
Tinsp Inspiratory time. Parameter that specifies the time of the ventilator’s inspiration
or the maximum time of spontaneous inspiration. Controlled parameter.
Tinsp/Ttot Factor of breathing cycle filling. Ratio of inspiratory time to total respiratory cycle
time.

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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.

VO2 Oxygen consumption (difference between oxygen concentration in the inhaled


and exhaled mixture).
Volume capnometry Measurement of the amount of CO2 released by the patient. Has a greater di-
agnostic and prognostic value than a conventional capnogram.
Volume capnometry Graphical representation of the instantaneous carbon dioxide released by the
graph patient.

Volume graph See V.


VT Tidal volume.
Vtmax The level of inspiratory volume limitation in the iSV mode calculated by the for-
mula Vtmax = (Vtmax calc. coeff.) x IBW, where IBW is the ideal weight and the
calculation coefficient Vtmax is set by the user in the range 7-30 ml / kg
Water trap Part of the breathing circuit. Water trap is intended for protection of device from
the liquid.
Work of the patient See Wspont.
breathing
Work of the ventilator See Wvent.
breathing
Wspont Work of the patient breathing. Energy consumption at respiratory movements. It
is calculated only by the spontaneous breaths. Work is 0 for hardware breaths.
Wvent Work of the ventilator breathing. Energy consumption at respiratory move-
Gl-7
GLOSSARY

ments. It is calculated only by the hardware breaths. Work is 0 for spontaneous


breaths.
Т disconn.in NIV Delay time of disconnection alarm triggering in the NIV mode.

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