Treaton MV200 User Manual
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Treaton MV200 User Manual

Intensive care ventilator
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TESM.941144.001-01 UM
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  • Page 1 MV200 TESM.941144.001-01 UM edition, 10/2019 edition 12/2016...

  • Page 3: Table Of Contents

    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 ................
  • Page 4 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 ............
  • Page 5 4.16.1 Function of service menu parameters ..........4-47 4.16.2 Calibration of FiO sensor, O 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 ..............
  • Page 6 6.7 Check and calibration of the FiO 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 CO sensor..........
  • Page 7 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 ...............

  • Page 9: Introduction

    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.
  • Page 10 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.
  • Page 11 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).

  • Page 12: General Guidance

    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.

  • Page 13: Symbols And References

    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...
  • Page 14 1.3 Symbols and references Equipotentiality Port for connection of the mainstream CO 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...
  • Page 15 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 Graph of iSV mode Paux Auxiliary external pressure graph Airway pressure graph PCО...

  • Page 16: Information About Resource Of The Main Functional Units Of The Device

    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).

  • Page 17: Description Of Device

    2.1 Basic parameters and characteristics DESCRIPTION OF DEVICE 2.1 Basic parameters and characteristics Parameter Value (description) General features Controlled and assisted artifical ventilation of lungs at the patients depending on hardware ventilation in resuscitation units, Intended use surgery and intensive care departments of professional medical facilities, and also at transportation within professional medical facilities.
  • Page 18 2.1 Basic parameters and characteristics Parameter Value (description) Continuous mandatory ventilation with the controlled pressure of inspiration (synchronized ventilation with CMV/PCV pressure control) Synchronized intermittent mandatory ventilation with flow trigger or pressure trigger with volume 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...
  • Page 19 2.1 Basic parameters and characteristics Parameter Value (description) 3.16 Expiration trigger sensitivity, ETS 5 - 80 % Periods of low pressure 0.5 - 30 s, 0 -35 cmH O (mbar) 3.17 and high pressure 1 - 30 s, 0 -70 cmH O (mbar) Gas leakage from the breathing circuit Up to 0,2 lpm...
  • Page 20 2.1 Basic parameters and characteristics Parameter Value (description) Alarms Automatic detection of alarm conditions. Sound and visual form, explanatory text Three levels of alarm with visual and audible alarm message with the alarm priority (high, me- dium, low) Disconnection of the patient Available Apnea Available...

  • Page 21: Configuration Of Device

    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 •...
  • Page 22 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-...
  • Page 23 2.2 Configuration of device Also used during measuring the auxiliary external pressure Mainstream CO module including: mainstream CO 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) •...
  • Page 24 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...

  • Page 25: Front Panel

    2.3 Front panel 2.3 Front panel Figure 2.1 – Front view of the electronic unit...
  • Page 26 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.

  • Page 27: Rear Panel

    2.4 Rear panel 2.4 Rear panel Power switch (in “O” position fully disconnects the device from the mains supply voltage) Cooling fan filter Communication interface socket (Ethernet) USB-port for connecting of the external USB-flash memory Equipotential terminal (potential balancing) Filter-regulator with the port for connection of the device to the oxygen source Water trap of the filter-regulator Fresh gas intake filter Connector for the low pressure oxygen line...

  • Page 28: Transport Cart (Mobile Trolley)

    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. Installation table Bracket for fixing of the supporting arm (circuit holder) Handle Panel for installation of the additional equipment Mounting bracket for humidifier...

  • Page 29: Preparing For Operation

    3.1 Operating conditions 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.
  • Page 30 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! •...
  • Page 31 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. •...

  • Page 32: Preparing For Operation

    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 •...
  • Page 33 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.

  • Page 34: Installation Of Humidifier

    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 •...
  • Page 35 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 w/o humi- VH-2000 MR810 MR850...
  • Page 36 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.
  • Page 37 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...
  • Page 38 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 filter.

  • Page 39: Connecting To The Oxygen Source

    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.
  • Page 40 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.
  • Page 41 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 FiO parameter in the range of values greater than 50 –...

  • Page 42: Device Turning On And Off

    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. •...
  • Page 43 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. •...

  • Page 44: Cleaning, Disinfection And Sterilization

    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.

  • Page 45: Reprocessing Of Sterilized Components

    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.
  • Page 46 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.
  • Page 47 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.
  • Page 48 3.5 Cleaning, disinfection and sterilization Component Procedure Comment Removable part of Disconnect the water trap and mem- Before sterilization make expiration valve sure that all ports and holes brane from emovable part. Repro- are cleaned properly. cess according to Reprocessing pro- cedure mentioned above.

  • Page 49: Device Control

    4.1 Main features of device 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; •...
  • Page 50 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.

  • Page 51: Reserve Power Supply

    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.

  • Page 52: Features Of Reserve Power Supply Operation

    4.2 Reserve power supply 4.2.2 Features of reserve power supply operation Table 4.1. Reserve power supply conditions Graphical Light indicator Reserve power supply condition symbol on the Alarm priority “BATTERY” display Charge from the mains Green Green Fully charged Green Discharge Yellow Yellow...

  • Page 53: Controls

    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: •...

  • Page 54: Starting Window. Beginning Of Ventilation

    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 –...

  • Page 55: Window Of Associated Parameters

    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"...

  • Page 56: Automatic Calculation Of Initial Ventilation Parameters

    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): •...

  • Page 57: Initial Alarm Settings

    4.4 Starting window. Beginning of ventilation Parameter Value Notice MV/Vt calculated values of MV, Vt 15 cmH children with IBW from 3 to 30 kg 15 cmH adults with IBW from 30 to 89 kg 18 cmH adults with IBW from 90 to 99 kg 20 cmH adults with IBW above 100 kg previous value...
  • Page 58 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] →...

  • Page 59: Main Window

    4.5 Main window 4.5 Main window 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.
  • Page 60 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.
  • Page 61 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.

  • Page 62: Main Menu

    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.

  • Page 63: Setting Of Ventilation Modes And Parameters

    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...

  • Page 64: Changing Of Parameters. Conflict Of Parameters

    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"...
  • Page 65 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.

  • Page 66: View Of Parameter Setting Line In The Different Ventilation Modes

    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 Top line Tplat TrigWnd Bottom line Pmax PEEP FormFlow Tinsp Ptrig Parameter setting line in the CMV/PCV mode Windows of parameters CMV/PСV...

  • Page 67: Description Of Ventilation Parameters

    4.7 Setting of ventilation modes and parameters Parameter setting line in the APRV mode Windows of parameters APRV Bottom line Phigh Plow Pramp Thigh Tlow Ftrig Parameter setting line in the NIV mode Windows of parameters Bottom line PEEP Facc Piapnea RBapnea Tapnea...
  • Page 68 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. •...
  • Page 69 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.

  • Page 70: Menu Of General Ventilation Parameters Setting

    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).
  • Page 71 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. on, off Trigger Vinsp 25ml Additional criterion of activation of the inspiratory...

  • Page 72: Menu Of Apnea Parameters

    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.

  • Page 73: Menu Of Isv Mode Parameters

    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 –...

  • Page 74: Setting Of The Type Of Inspiration Trigger

    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.

  • Page 75: Automatic Calibration Of The Oxygen Sensor

    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 FiO at the changing of the external conditions: temperature, pressure or aging of oxygen sensors.

  • Page 76: Additional Functions

    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; •...
  • Page 77 4.11 Additional functions PEEP increment value is set in the menu. It can be changed in the range from 3 to 25 cmH By clicking on the "Start" row, the maneuver starts and the icon changes its color to indicate the activation of the mode.

  • Page 78: Oxygenation

    4.11 Additional functions 4.11.2 Oxygenation Activation of the function is available through [Menu] → [Additional functions] → [FiO 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.

  • Page 79: Standby Mode

    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; •...

  • Page 80: Leak Compensation

    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.

  • Page 81: Manual Breath (Manual Ventilation)

    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.

  • Page 82: Screen Lock

    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.

  • Page 83: Freezing" / Analysis Of Graphs

    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.

  • Page 84: Display Settings Menu

    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 →...
  • Page 85 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.
  • Page 86 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.

  • Page 87: Menu Of Settings Of Measuring Parameter Blocks

    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 Empty No data...

  • Page 88: Menu Of View Of Trends And Alarm Log

    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).
  • Page 89 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.
  • Page 90 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 № Peak inspiratory pressure PEEP Positive end-expiratory pressure Mean pressure for the respiratory cycle Minute volume MVexp Expiratory minute volume MVspont Minute volume of spontaneous breaths...
  • Page 91 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.

  • Page 92: Alarm Settings Menu

    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 sensor – display of FiO readings on/off (dashes «---»...
  • Page 93 4.14 Alarm settings menu Line of the Designation, description of parameters Possible values Default value menu EtCO _min…12 EtCO _max – top alarm threshold of СО concentration in exhaled air [%]. 2… EtCO _max EtCO _min – bottom alarm threshold of СО concentration in exhaled air [%].

  • Page 94: Volume Settings Menu

    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...

  • Page 95: Service Menu

    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.

  • Page 96: Module

    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”...
  • Page 97 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...
  • Page 98 4.16 Service menu where: Zero calibration for MS capno parameter is used for running of mainstream capnometer zeroing routine (see it. 5.1); Calorimeter O 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;...
  • Page 99 4.16 Service menu 4.16.2 Calibration of FiO sensor, O2 sensor of metabolism measurement module Calibration of FiO sensor Calibration of the oxygen sensor measuring the concentration in the inspiratory gas (FiO ) is conducted in the following cases: During maintenance. •...
  • Page 100 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] →...

  • Page 101: Expiratory Flow Sensor Calibration

    4.16 Service menu Calibration of O sensor of metabolism measurement module If the device has metabolism measurement module, the fast oxygen sensor calibration is re- quired. This sensor measures FiO in Metabolism window and shows the difference of the oxy- gen concentration at the inhalation and exhalation FiO - EtO enter [Menu]...

  • Page 102: Selection Of Flow Correction Conditions On The Inspiration And The Expiration

    4.16 Service menu Message Alarm condition Operator’s actions Incorrect coeff. for differential Ventilation controller malfunc- Contact the customer service press. sensor tion Error: no response from power Power unit malfunction Contact the customer service unit Error: temperature sensor Power unit malfunction Contact the customer service error in power unit Error: low ambient air...

  • Page 103: Breathing Circuit Calibration

    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] →...
  • Page 104 4.16 Service menu Message Alarm condition Operator’s actions Could not switch CIVL to Ventilation controller does Contact the customer service. calibration mode not respond to the requests of breathing circuit calibration. Monotony error in input table User incorrectly followed the Repeat the breathing circuit breathing circuit calibration calibration.

  • Page 105: Alarms

    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.
  • Page 106 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.

  • Page 107: High Priority Alarms

    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 connections. Check the tightness of the (Disconnection) Pressure drop in the patient’s breathing circuit and expiration valve of the breathing circuit...
  • Page 108 4.17 Alarms Reaction of ventilator, No Alarm message Alarm conditions operator’s actions 9 High EtCO High EtСО Check the patient for adequate ventilation and circuit for hermiticity. If necessary adjust (High EtСО The measured value of the CO the top alarm limit. Alarm is disabled at de- concentration is above the set creasing of the exhalation volume below the top threshold.

  • Page 109: Medium Priority Alarms

    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 is insufficient to continue the will be removed after beginning of the charg- (Acc Discharged) normal operation of the device...
  • Page 110 4.17 Alarms Reaction of ventilator, No Alarm message Alarm conditions operator’s actions Low RB Controlled respiratory rate is The alarm is automatically disabled when the below the specified bottom respiratory rate is equal or higher than alarm (Low RB) threshold. threshold.

  • Page 111: Low Priority Alarms

    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.
  • Page 112 4.17 Alarms Alarm mes- Reaction of ventilator, Alarm conditions sage operator’s actions Capnometer off No connection with the capno- Turn on the capnometer through the menu. meter After restoring of communication message (Capnometer off) disappears. If capnometer does not operate, contact service department.

  • Page 113: Informational Messages

    4.17 Alarms 4.17.4 Informational messages Message Alarm Indica- Comment tion zone Power-up (Power-up) Shutdown (Shutdown) sensor disconnected To continue monitoring, connect the (SpO sens.disc) pulse oximetry sensor to the device. Capnometer warming (Capno Capnometer warming. At the end of warming) warming up the message will auto- matically disappear.

  • Page 114: Special Alarms Of Isv Mode

    4.17 Alarms Message Alarm Indica- Comment tion zone Standby mode Activation of Standby mode (Standby mode) Manual breath Activation of Manual breath function (Manual breath) Technical Message x Service messages. A detailed de- scription of the malfunction and an (1 or 2) indication of the unit in which the (Tech.
  • Page 115 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: •...
  • Page 116 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...

  • Page 117: Extended Respiratory Monitoring

    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"...
  • Page 118 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 ×...
  • Page 119 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.

  • Page 120: Nebulizer

    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.
  • Page 121 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.
  • Page 122 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.

  • Page 123: Open Valve" Function

    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.
  • Page 124 4.21 "Open valve" function For your notes 4-76...

  • Page 125: Optional Features Of The Device

    5.1 Mainstream CO2 sensor (capnometer) OPTIONAL FEATURES OF THE DEVICE 5.1 Mainstream CO sensor (capnometer) External module of breathing gas analysis without sampling (hereinafter – mainstream capno- meter) is optionally delivered with the device and allows to monitor: СО concentration at the end (EtСО ) and at the beginning (FiCO ) of the exhalation;...
  • Page 126 5.1 Mainstream CO2 sensor (capnometer) Figure 5.3 – Connecting the CO sensor to the CO 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: PCO (%) or PCO (mmHg).
  • Page 127 5.1 Mainstream CO2 sensor (capnometer) Do not use CO measurement results as the only basis for measuring venti- lation parameters without taking into account clinical data and independent indicators, such as blood gases. CO measurements may be inaccurate if there is a leak in the circuit or the sensor is fault. Place the CO sensor and cable in a such way to avoid entanglement, suffo- cation, or accidental rupture of the cable...
  • Page 128 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 CO in the mea- suring cell of the adapter used in the calibration during the whole calibration interval which takes up to 30 seconds.

  • Page 129: Volume Capnometry

    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: •...
  • Page 130 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: ∫ EtCO −...

  • Page 131: Cardiac Output By Fick

    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 VCO and alveolar con- centration of CO for calculation of cardiac output CO.
  • Page 132 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 PvCO and PаCO they are checked for cor- rectness: • permitted range 10 - 150 mm Hg, •...

  • Page 133: Pulse Oximetry Module

    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 SpО • 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.
  • Page 134 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.
  • Page 135 5.4 Pulse oximetry module Figure 5.10 – Application of universal pulse oximetry sensor to child or adult monitroring: • Select the SpO 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.
  • Page 136 5.4 Pulse oximetry module The "PR and SpO averaging time" parameter is set depending on the patient's mobility and re- gulates the averaging time of the displayed SpO 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.
  • Page 137 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.

  • Page 138: Metabolism Measurement Module

    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 VO , ml/min; • elimination of CO per minute VCO , ml/min;...
  • Page 139 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*.
  • Page 140 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 PCO , PO [%] window, where capnogram and oxigram of the respiratory cycle (FiO2(t) - EtO2(t)) are displayed simultaneously.
  • Page 141 5.5 Metabolism measurement module No Alarm message Alarm conditions Reaction of ventilator, operator’s actions Drying Drying of the line The message disappeared automatically af- ter calibration finishing. User turn off Turned off by user The message disappeared automatically af- ter turning on the metabolism module. Off.
  • Page 142 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.

  • Page 143: Compensation Of Endotracheal Tube Resistance

    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); •...

  • Page 144: Auxiliary External Pressure" Function

    5.7 “Auxiliary external pressure” function 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;...
  • Page 145 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.
  • Page 146 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 •...
  • Page 147 5.7 “Auxiliary external pressure” function 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. •...

  • Page 148: Operating With Low Pressure Oxygen Source

    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 –...

  • Page 149: Data Exchange With Computer

    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.
  • Page 150 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.

  • Page 151: Maintenance Of The Device

    6.1 Maintenance schedule 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.

  • Page 152: Visual Inspection And Test Of Controls

    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.

  • Page 153: Check Of The Filter-Regulator

    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 O port.

  • Page 154: Check And Calibration Of The Fio Oxygen Sensors And The Metabolism Measurement Module

    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 FiO oxygen sensors and the metabol- ism measurement module The device contains two oxygen sensors - the FiO2 oxygen sensor and the oxygen sensor of...

  • Page 155: Check Of Built-In Accumulator

    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.

  • Page 156: Check Of The Set Tidal Volume

    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. •...

  • Page 157: Check And Calibration Of Mainstream Co2 Sensor

    6.11 Check and calibration of mainstream CO2 sensor • Connect the mainstream CO sensor to the device in accordance with it. 5.1. During the cali- bration procedure, the airway adapter shall be installed in the mainstream CO sensor and disconnected from the breathing circuit. •...
  • Page 158 6.11 Check and calibration of mainstream CO2 sensor For your notes...

  • Page 159: Troubleshooting

    7. Troubleshooting 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 "...
  • Page 160 7. Troubleshooting For your notes...

  • Page 161: Transportation

    8. Transportation 9. Storage 10. Disposal 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/cm (bar)), to turn on the device, and leave it for 3 - 5 mi-...
  • Page 162 8. Transportation 9. Storage 10. Disposal For your notes 10-2...

  • Page 163: Warranty

    11. Warranty 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.

  • Page 164: Guarantee Procedure

    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);...

  • Page 165: Certificate Of Acceptance

    12 Certificate of acceptance 12 CERTIFICATE OF ACCEPTANCE Intensive Care Ventilator MV200 serial No _________________________ , software kit No_________________________ complies with technical specifications TESM.941144.001 TU and considered suitable for operation. Date of manufacturing____________________ QC stamp QC representative________________/___________________/ signature name 13 COMMISSION DATE MARK...
  • Page 166 13 commission date mark For your notes 12-2...

  • Page 167: Maintenance And Repair Data

    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...
  • Page 168 14 Maintenance and repair data For your notes 14-2...

  • Page 169: Appendix 1 Description Of Ventilation Modes

    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.

  • Page 170: Appendix 1.2 Description Of Cmv / Pcv Mode

    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.

  • Page 171: Appendix 1.3 Description Of Simv/Vc, Simv/Pc, Simv/Dc Modes

    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.

  • Page 172: Appendix 1.4 Description Of Cpap+Ps Mode

    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).

  • Page 173: Appendix 1.5 Description Of Bistep Mode

    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.
  • Page 174 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) Phigh Plow Thigh Tlow Figure App.
  • Page 175 Appendix 1.5 Description of BiSTEP mode P(t) 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) Phigh...

  • Page 176: Appendix 1.6 Description Of Niv Mode

    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.

  • Page 177: Appendix 1.7 Description Of Aprv Mode

    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.

  • Page 178: Appendix 1.8 Description Of Pcv-Vg Mode

    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.

  • Page 179: Appendix 1.9 Description Of Apnea Mode

    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.

  • Page 180: Appendix 1.10 Description Of The Intelligent Adaptive Ventilation Isv

    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.

  • Page 181: Appendix 1.10.2 Assessment Of Respiratory Rate

    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.

  • Page 182: Appendix 1.10.5 I:e Ratio, Medical Aspects

    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 –...

  • Page 183: Appendix 1.10.7 Start Of Isv Mode

    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, cmH...

  • Page 184: Appendix 1.10.8 General Description Of The Isv Pattern Mode Adjustment Algorithm

    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.

  • Page 185: Appendix 1.10.9 Function Of Mv Adaptation

    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.

  • Page 186: 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 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...

  • Page 187: Appendix 2 Methods Of Determining Parameters

    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.

  • Page 188: Appendix 2.3 Mean Pressure In The Circuit For The Respiratory Cycle (Pmean)

    Appendix 2.3 Mean pressure in the circuit for the respiratory cycle (Pmean) P(t) autoPEEP 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.

  • Page 189: Appendix 2.4 Time Constant Of The Respiratory Tract (Τexp, Τinsp)

    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 (τ...

  • Page 190: Appendix 2.5 Work Of Breathing (Wob)

    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.

  • Page 191: Appendix 2.6 Rapid Shallow Breathing Index (Rsbi)

    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.
  • Page 192 Appendix 2.7 Stress index (SI) P(t) P(t) P(t) SI=1.4 SI=0.8 SI=1.0 F(t) F(t) F(t) Figure App.2.4 – Volume control: pressure graphs at normal (SI = 1), low (SI < 1) and high (SI>1) stress-index 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).
  • Page 193 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.

  • Page 194: Appendix 2.9 Ideal Body Weight Of The Patient (Ibw)

    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.
  • Page 195 Appendix 2.9 Ideal body weight of the patient (IBW) 15.2 15.0 15.4 15.3 15.7 15.6 16.0 15.9 16.3 16.2 16.6 16.5 16.9 16.9 17.3 17.2 17.6 17.6 17.9 18.0 18.3 18.3 18.9 19.0 19.2 19.4 19.6 19.8 20.0 20.2 20.4 20.7 20.8 21.1...
  • Page 196 Appendix 2.9 Ideal body weight of the patient (IBW) For your notes App.2-10...

  • Page 197: Appendix 3 Electromagnetic Environment

    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 –...
  • Page 198 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 fields should be at levels cha- (50/60 Hz) racteristic of a typical location magnetic field in a typical commercial or hos- IEC 61000-4-8:2009 pital environment.
  • Page 199 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.
  • Page 200 Appendix 3 Electromagnetic environment For your notes App.3-4...

  • Page 201: Appendix 4 Pneumatic Scheme Of Ventilator

    Appendix 4 Pneumatic scheme of ventilator APPENDIX 4 PNEUMATIC SCHEME OF VENTILATOR App.4-1...
  • Page 202 Appendix 4 Pneumatic scheme of ventilator For your notes App.4-2...

  • Page 203: Appendix 5 Technical Malfunction And Events

    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 •...

  • Page 204: Appendix 5.2 Technical Messages

    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.

  • Page 205: Appendix 6 Delivery Set

    Appendix 6 DELIVERY SET APPENDIX 6 DELIVERY SET Name Part number Quantity, items TESM.941144.001-01 Triton Electron- Intensive Care Ventilator MV200 ic Systems Ltd, Russian Federation including: TESM.230001 Triton Electronic Sys- electronic unit tems Ltd, Russian Federation TESM.186143 Triton Electronic Sys-...
  • Page 206 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 Ltd, New Zealand 1.16 patient circuit, disposable, neo- by special order natal 038-03-340С...
  • Page 207 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 Cirrus REF 2605 Intersurgical Ltd, UK 1.29 nebulizer Aeroneb Aerogen Ltd, Ireland by special order NovaStar, size L Draeger, Germany 1.30 mask...
  • Page 208 Appendix 6 DELIVERY SET Name Part number Quantity, items Catheter TESM.046502 Triton Electronic Sys- 1.45 by special order tems Ltd, Russian Federation Spare parts: T2.0AL/250V Radiodetal, Russian fuse Federation TESM.189017 Triton Electronic Sys- microfilter tems Ltd, Russian Federation TESM.236501 Triton Electronic Sys- membrane tems Ltd, Russian Federation TESM.009926 Triton Electronic Sys-...

  • Page 209: Appendix 7 Additional Parameters And Characteristics

    Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS APPENDIX 7 ADDITIONAL PARAMETERS AND CHARACTE- RISTICS Parameter Value (description) 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.
  • Page 210 Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS 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.
  • Page 211 Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS Parameter Value (description) 3.12. Endotracheal tube compensation, ETC 0 - 100 % Respiratory monitoring parameters 4.1. Mean pressure for the respiratory cycle 4.2. Residual pressure level in lungs AutoPEEP 4.3. Minute volume of spontaneous breaths MVspont 4.4.
  • Page 212 Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS 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).
  • Page 213 Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS 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"...
  • Page 214 Appendix 7 ADDITIONAL PARAMETERS AND CHARACTERISTICS Parameter Value (description) Transmitted data: screenshot (current status of the screen), the alarm log, the service log, Interface for connecting USB flash memory device selected segment of trend. (USB connector on the rear panel). App.7-6...

  • Page 215: Glossary

    GLOSSARY GLOSSARY Failure of compliance and resistance measurement Factor of increasing/decreasing of target MV in the iSV mode. Expiratory time constant (RCexp). Time constant determining the potential τ τ τ τ exp rate of pressure change in the lungs during expiratory phase. Calculated pa- rameter displayed in RESP2 window.
  • Page 216 GLOSSARY CAPN MS Mainstream capnometer (service menu message). CAPNO Symbol of CO 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.
  • Page 217 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 Full emergency mode.
  • Page 218 GLOSSARY Minute alveolar ventila- See MValv tion Minute volume See MV Mainstream CO sensor (service menu message). 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.
  • Page 219 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). Mean pressure for the respiratory cycle. Pmax Maximum acceptable inspiratory pressure. Pmin Minimum acceptable support pressure of spontaneous breaths. Pressure measurement module (service menu message).
  • Page 220 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.
  • Page 221 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.
  • Page 222 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. Gl-8...

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