Mindray SynoVent E5 Operator's Manual
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Mindray SynoVent E5 Operator's Manual

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SynoVent E5 Ventilator
Operator's Manual

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  • Page 1 SynoVent E5 Ventilator Operator’s Manual...
  • Page 3 © 2010-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is April, 2014.
  • Page 4 Mindray is strictly forbidden. and SynoVent are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their...
  • Page 5 Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
  • Page 6 FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
  • Page 7 Customer Service Department Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China Website: www.mindray.com E-mail Address: service@mindray.com Tel: +86 755 81888998 Fax: +86 755 26582680 EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, 20537 Hamburg, GERMANY...
  • Page 8 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product.

  • Page 9: Table Of Contents

    Table of Contents 1 Safety ..........................1-1 1.1 Safety Information ......................1-1 1.1.1 Dangers ......................1-2 1.1.2 Warnings ......................1-2 1.1.3 Cautions ......................1-4 1.1.4 Notes ........................1-6 1.2 Equipment Symbols ......................1-7 2 The Basics ......................... 2-1 2.1 System Description ......................2-1 2.1.1 Intended Use.......................
  • Page 10 4.3 Spirometry Loops Screen ....................4-7 4.4 Graphic Trend Screen ...................... 4-8 4.5 Tabular Trend Screen ....................4-10 4.6 Measured Values Screen ....................4-11 4.7 Freeze ..........................4-12 5 System Settings ......................... 5-1 5.1 Change Display Settings ....................5-1 5.1.1 Waveforms ......................5-1 5.1.2 Spirometry Loops ....................
  • Page 11 6.4 System Check ........................6-2 6.5 Select Patient ........................6-3 6.6 Ventilation Type ......................6-4 6.6.1 Invasive Ventilation .................... 6-4 6.6.2 NIV (non-invasive ventilation) ................6-5 6.6.3 Set Ventilation Type ................... 6-5 6.7 Ventilation Mode ......................6-6 6.7.1 Ventilation Mode and Parameter Setup .............. 6-6 6.7.2 Apnea Ventilation ....................
  • Page 12 8.7 P0.1 ..........................8-4 8.8 NIF ..........................8-4 8.9 PEEPi ..........................8-5 8.10 P-V Tool ........................8-5 9 Alarms ..........................9-1 9.1 Introduction ........................9-1 9.2 Alarm Categories ......................9-1 9.3 Alarm Levels ........................9-2 9.4 Alarm Indicators ......................9-2 9.4.1 Alarm Lamp .......................
  • Page 13 10.2.4 Breathing Hoses ..................... 10-7 10.2.5 Nebulizer ......................10-8 10.2.6 Humidifier ...................... 10-9 10.2.7 O2 Sensor ..................... 10-12 11 Maintenance ........................11-1 11.1 Repair Policy ........................ 11-1 11.2 Maintenance Schedule ....................11-2 11.3 Pressure and Flow Zeroing ................... 11-3 11.4 Flow Sensor Calibration ....................11-4 11.5 O2 Concentration Calibration ..................
  • Page 14 C EMC ..........................C-1 D Alarm Messages ......................D-1 D.1 Physiological Alarm Messages ..................D-1 D.2 Technical Alarm Messages .................... D-2 E Factory Defaults ......................E-1 E.1 CO2 Module ........................E-1 E.2 Alarm ..........................E-1 E.3 Ventilation Mode ......................E-2 F Symbols and Abbreviations .....................

  • Page 15: Safety

    Safety 1.1 Safety Information DANGER Indicates an imminent hazard that, if not avoided, will result in death or serious  injury. WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in  death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in ...

  • Page 16: Dangers

    1.1.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual. 1.1.2 Warnings WARNING The ventilator must only be operated and used by authorized medical personnel ...
  • Page 17 WARNING  Positive pressure breathing may be accompanied by some side effects such as barotrauma, hypoventilation, hyperventilation etc.  Using the ventilator in the vicinity of high-frequency electrosurgery units, defibrillators or short-wave therapy equipment may impair correct functioning of the ventilator and endanger the patient. ...

  • Page 18: Cautions

    WARNING  When the ventilator input system fails or has faults, please contact us immediately for specified personnel to service the ventilator.  Use the humidifiers with a CE mark or recommended by us only. The ventilator cannot use He and O2 mixed gas. ...
  • Page 19 CAUTION  To ensure patient safety, use only parts and accessories specified in this manual. At the end of its service life, the equipment, as well as its accessories, must be  disposed of in compliance with the guidelines regulating the disposal of such products.

  • Page 20: Notes

    1.1.4 Notes NOTE  Put the equipment in a location where you can easily see the screen and access the operating controls.  Keep this manual close to the equipment so that it can be obtained conveniently when needed.  The software was developed in compliance with IEC 60601-1-4.

  • Page 21: Equipment Symbols

    1.2 Equipment Symbols Alternating current Battery Equipotential Fuse RS-232 port CO2/calibration connection O2↑button O2 sensor connector Video input/output VGA output connection connection Network connection USB port Air supply connection Oxygen supply connection Pneumatic outlet Flow sensor Expiratory port Inspiratory port Unlock Nebulizer connection Compressor status indicator...
  • Page 22 Refer to instruction General warning sign manual/booklet No pushing Protective earth (ground) The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health.

  • Page 23: The Basics

    The Basics 2.1 System Description 2.1.1 Intended Use The Ventilator is intended to provide ventilation assistance and breath support for adult, pediatric and infant patients with respiratory insufficiency or respiratory failure in the hospital or other medical institutions. Ventilation may be delivered via mask or tracheotomy. This product must be operated by doctors, respiration therapist or other specially trained and authorized personnel.

  • Page 24: Equipment Appearance

    2.2 Equipment Appearance 2.2.1 Front View...
  • Page 25 Caster and brake The four casters of the ventilator have brakes. Compressor Inspiratory water trap Collects condensed water in the hose. Expiratory water trap Collects condensed water in the hose. Test lung Expiratory hose Inspiratory hose Support arm Supports the patient’s breathing hoses. Display 10.

  • Page 26: Rear View

    2.2.2 Rear View RS-232 port Connects to the medical-grade external device via RS-232 protocol to implement the communication between the ventilator and external device. Oxygen supply connection(with filter water trap) Air supply connection(with filter water trap) CO2/calibration connection One multiplex connector for calibrating inspiratory and expiratory flows and supplying power for the external CO2 analyzer.

  • Page 27: Air Compressor

    connection allows for interfacing to an externally located 24 bits, 800 x 600, SVGA monitor, which should be a medical grade monitor. USB port Network connection One multiplex connector for network and software online upgrade. 10. Nurse call connection Connects to the hospital’s calling system and outputs nurse call signals when an alarm occurs.
  • Page 28 Alarm indicator The alarm indicator is lit when the compressor internal temperature is abnormally high. In this case, the compressor may shut off at any time and stop delivering gas. Pressure gauge The pressure gauge indicates the air pressure at the compressed air outlet. Compressed air outlet Central pipeline gas supply inlet Power switch...

  • Page 29: Installations And Connections

    Installations and Connections WARNING Do not use antistatic or conductive masks or breathing hoses. They can cause burns  if they are used near high frequency electrosurgical equipment. To ensure optimum performance of the ventilator, re-do system check each time ...

  • Page 30: Install The Display Onto The Pendant

    Put the display onto the ventilator and align the display with the screw holes. Install the three screws to fix the display. Insert the three screw plugs. Connect the display connection line to the Video input/output port and tighten the two fixing knobs.
  • Page 31 A. Screw Display bracket base disk Fixing block D. ICU pendant pole Knob for fixing block Loosen the knob for fixing block. Put the fixing block onto the ICU pendant pole. Tighten the knob for fixing block. Put the display onto the display bracket base disk and align the display with the screw holes.

  • Page 32: Connect The Power Supply

    3.2 Connect the Power Supply 3.2.1 Connect the System Power Supply A. AC power cord AC Power cord retainer Screw Plug the AC power cord into the AC power outlet. Place the AC power cord retainer above the power outlet and align the retainer with the screw holes.

  • Page 33: Connect The Main Unit Power Supply

    3.2.2 Connect the Main Unit Power Supply A. Main unit power cord Main unit power cord retainer Screw Plug the main unit power cord into the power outlet. Place the main unit power cord retainer above the power outlet and align the retainer with the screw holes.

  • Page 34: Connect The Compressor Power Supply

    3.2.3 Connect the Compressor Power Supply A. Compressor Compressor power cord Plug the compressor power cord into the auxiliary electrical outlet specially for compressor directly.

  • Page 35: Connect The Gas Supply

    3.3 Connect the Gas Supply A. Oxygen supply connection Air supply connection Compressor The ventilator provides two supply gas connections: oxygen and air. The supply gas hoses are differentiated by different colors. Do not attempt to switch oxygen and air supply connections.

  • Page 36: Install The Support Arm

    The ventilator works normally under supply pressure of 280 to 650 kPa. Supply pressure of less than 280 kPa can impair the performance of the ventilator and even cease ventilation. Supply pressure between 650 and 1000 kPa can impair the performance of the ventilator but will not cause any hazard arising from high pressure gas.
  • Page 37 Adjust the support arm.  Support arm joint E or G: To adjust the bending angle of the support arm downward, push and hold the blue button on support arm joint E or G with one hand and hold the support bar and press it downward with the other hand. Support arm joint E or G can be adjusted for up to 130°.

  • Page 38: Install The Water Traps

    3.5 Install the Water Traps A. Water trap on the breathing hose Water trap on the expiration valve assembly Rotate to push in the water trap upward. Make sure that the water trap is installed in place. 3-10...

  • Page 39: Install The Breathing Hoses

    3.6 Install the Breathing Hoses A. Inspiratory filter Expiratory filter Inspiratory water trap D. Expiratory water trap Support arm hook Mount the filters onto the inspiratory and expiratory ports. Connect the inspiratory filter to the water trap via the hose. Connect the other end of the hose to the Y piece.

  • Page 40: Install The Humidifier

    3.7 Install the Humidifier Note Install the humidifier which complies with the specification. The humidifier  assembly and its installation steps described here are only for reference. 3.7.1 Install the Humidifier onto the Ventilator A. Humidifier Humidifier sliding wheel Humidifier bracket fixed seat D.
  • Page 41 Mount the filters onto the inspiratory and expiratory ports. Connect the inspiratory filter to the humidifier inlet via the hose. Connect the humidifier outlet to the water trap via the hose. Then, connect the water trap to the Y piece via the hose. Connect the expiratory filter to the water trap via the hose.

  • Page 42: Install The Humidifier Onto The Pendant

    3.7.2 Install the Humidifier onto the Pendant A. Humidifier Knob for fixing block Fixing block D. Humidifier sliding wheel Humidifier bracket fixed seat Screw G. Beam Loosen the knob for fixing block. Put the fixing blocking onto the pendant beam. Tighten the knob for fixing block.

  • Page 43: Install The Nebulizer

    WARNING  When installing the humidifier, make sure that the humidifier connector shall be lower than the ventilator’s breathing connectors and the patient when installing the humidifier. 3.8 Install the Nebulizer A. Nebulizer connector Nebulizer hose Nebulizer Connect one end of the nebulizer hose to the nebulizer connector and the other end of the hose to the nebulizer.

  • Page 44: Install The Co2 Module

    WARNING  Nebulization yields the best performance at flow of 6 L/min. Nebulizers with other flows can create significant errors in tidal volume and oxygen mix. 3.9 Install the CO2 Module A. Fastening screws for CO2 module mounting plate B. CO 2 module Fastening screws for CO2 module D.

  • Page 45: Install The O2 Sensor

    Place the CO2 module onto the mounting plate and align with the screw holes. Then tighten the three fastening screws. Connect the connection line at the back of the CO2 module to the ventilator’s CO2/calibration connection. Connect one end of the sampling line to the water trap and then mount the water trap onto the CO2 module.
  • Page 46 FOR YOUR NOTES 3-18...

  • Page 47: User Interface

    User Interface 4.1 Display Controls The control unit is characterized by the small number of operating elements. Its main elements are: Display (touch screen) The display shows the software screen of the ventilator system. You can select and change settings by touching the screen. Fixed hard keys The fixed hard keys are provided for rapid access to the ventilator’s major functions.

  • Page 48: Display

    AC power LED and battery LED  indicates the AC power LED.  Lit: when the ventilator is connected to the AC power source. Extinguished: when the ventilator is not connected to the AC power source.   indicates the battery LED. Lit: when the battery is being charged or is already fully charged and the ventilator ...
  • Page 49 Ventilation mode field Displays Standby or active ventilation mode, and ventilation assist. 2. NIV/ intubation icon field Displays NIV when it is non-invasive ventilation, or intubation icon when it is invasive ventilation. Mask/ ATRC and pipe diameter field Displays mask icon when it is non-invasive ventilation, or blank when it is invasive ventilation and dynamic tube compensation is turned off, or ATRC and pipe diameter when it is invasive ventilation and dynamic tube compensation is endotracheal...

  • Page 50: Fixed Hard Keys

    11. Ventilation mode setup field Displays keys for setting ventilation mode. 12. Waveforms/spirometry/trends/measured values filed Displays waveforms, spirometry loops, graphic trend, tabular trend, or measured values. 4.1.2 Fixed Hard Keys Alarm Silence key Push to silence alarm audio of an active alarm for 120 seconds. When 120 seconds expires, the system exits alarm silenced status automatically and resumes alarm audio.
  • Page 51 Latching alarms: the system continues displaying the alarm message even if the alarm conditions end except that: Alarm audio disappears;  Alarm LED stops flashing and is permanently lit with the same color;  Alarm message is displayed without background color; ...

  • Page 52: Waveforms Screen

    13. O2↑key/suction In non-standby status, push to start O2↑function and the LED in the upper left corner of this key is lit. The screen shows the remaining O2↑ time. When O2↑is active, push this key again to stop O2↑. During O2↑, removing the breathing hoses enters suction screen.

  • Page 53: Spirometry Loops Screen

    4.3 Spirometry Loops Screen Select [Spirometry] to access the spirometry loops screen as shown below. Spirometry loops reflect patient lungs function and ventilation condition as well, such as the patient’s lungs compliance, over-inflation, breathing system leakage and airway blockage. The system provides three types of spirometry loops: P-V (pressure-volume) loop, F-V (flow-volume) loop, and F-P (flow-pressure) loop.

  • Page 54: Graphic Trend Screen

    time moments are already saved, when [Save] is selected again, the system automatically clears the oldest reference loops except the loops being viewed and saves the current loops as reference loops. 4.4 Graphic Trend Screen Graphic trend depicts the changes in parameter measured values in graphic form over a specific period of time.
  • Page 55 Cursor Time field, displaying the time corresponding to the cursor. Parameter area, displaying parameter values at the time corresponding to the cursor. Vertical scroll bar, indicating the position of the currently displayed parameter in the entire parameter sequencing. Button for switching between graphic trend and tabular trend 10.

  • Page 56: Tabular Trend Screen

    4.5 Tabular Trend Screen Tabular trend depicts the changes in parameter measured values in tabular form over a specific period of time. You can access the following tabular window by selecting [Trends] and/or selecting the button for switching between [Tabular] and [Graphic]. Event mark field, displaying event marks in the current trend window.

  • Page 57: Measured Values Screen

    Button for parameter grouping. Options are [All], [Pressure], [Volume], [Time] and [Other]. [Pressure] parameters include Ppeak, Pplat, Pmean, and PEEP. [Volume] parameters include TVi, TVe, TVe spn, MV, MVspn, and MVleak. [Time] parameters include ftot, fmand, and fspn. [Other] parameters include Ri, Re, Cdyn, RSBI, WOB, FiO2, FiCO2 and EtCO2.

  • Page 58: Freeze

    4.7 Freeze The freeze function features to pause on-screen waveforms and spirometry loops refreshing in real-time and review short-time patient data so that you can have a close examination of the patient’s status within this time period. Enter freeze status In non-standby or non-freeze status, push the Freeze key and [Freeze Active.
  • Page 59 View frozen spirometry loops You can turn the control knob clockwise or counter clockwise to move the cursor to view the frozen spirometry loops. Exit freeze status In freeze status, push the Freeze key to exit the freeze status. In freeze status, if no operation is performed on the ventilator for more than three (3) minutes, the system exits freeze status automatically.
  • Page 60 FOR YOUR NOTES 4-14...

  • Page 61: System Settings

    System Settings 5.1 Change Display Settings 5.1.1 Waveforms Push the Menu key. Select [Display] and then [Waveforms]. Select the waveforms to be displayed. Select [Draw Wave] and toggle between [Curve] and [Fill]. [Curve]: the waveform is displayed as a curved line. ...

  • Page 62: Colors

    5.1.4 Colors To change the colors of waveforms, waveform related parameters, waveform related spirometry loops, and waveform related alarm limits: Push the Menu key. Select [Display] and then [Color]. Select the desired color. The colors of waveforms, waveform related parameters, waveform related spirometry loops also change.

  • Page 63: Set Date And Time

    5.2 Set Date and Time Push the Menu key. Select [System] and then [Time]. Set the date and time. Select [Date Format] and toggle between [YYYY-MM-DD], [MM-DD-YYYY] and [DD-MM-YYYY]. Select [Time Format] and toggle between [24 h] and [12 h]. 5.3 Change Language Push the Menu key.

  • Page 64: Set Paw Unit

    5.6.2 Set Paw Unit Push the Menu key. Select [System] and then [Unit]. Select [Paw Unit] and toggle between [cmH2O], [hPa], and [mbar]. 5.6.3 Set CO2 Unit Push the Menu key. Select [System] and then [Unit]. Select [CO2 Unit] and toggle between [mmHg], [kPa], and [%]. 5.7 Turning on/off O2% Monitoring Push the Menu key.

  • Page 65: Set Ip Address

    5.11 Set IP Address If your ventilator needs to upgrade the software, follow these steps to set the IP address: Push the Menu key. Select [Maintain] → [User] → enter the required password → [Setup] → [IP Address]. Set the IP address. IP address has four step boxes. The setting range of each of the box is 0 to 255.

  • Page 66: Save As User Configuration

    5.12.3 Save as User Configuration You can change the ventilator’s settings based on the actual requirement and save the changed settings as user configuration. Push the Menu key. Select [Maintain] → [User] → enter the required password → [Config]. If the current patient type is adult, select [Save as User Adu Config]. If the current patient type is pediatric, select [Save as User Ped Config].

  • Page 67: Export

    5.14 Export The ventilator’s export function means to export some data to USB memory. 5.14.1 Export Screen Screen export means to export the last saved screen capture of the ventilator. The exported file is in bmp format. To export screenshot, Insert the USB memory to the USB port of the ventilator.
  • Page 68 FOR YOUR NOTES...

  • Page 69: Start Ventilation

    Start Ventilation 6.1 Turn on the System Plug the power cord into the AC power outlet. Make sure that the AC power LED is lit. Push and hold the key. The alarm LED flashes yellow and red once in turn and then the speaker and buzzer give a self-test sound.

  • Page 70: Power On Self-Test

    6.2.2.2 Air Pipeline Test Connect an air supply or air compressor gas supply. Connect the test splint lung. Push the key to start the ventilator. Select adult ventilation mode and make the ventilator start ventilation. Make sure that the ventilator ventilates properly. Disconnect the air pipeline supply or air compressor gas supply.

  • Page 71: Select Patient

    System check items include:  O2 flow sensor test: test the O2 inspiratory valve and O2 flow sensor;  Air flow sensor test: test the Air inspiratory valve and Air flow sensor;  Expiratory flow sensor test;  Pressure sensor test: test the pressure sensors at the inspiratory and expiratory ports; ...

  • Page 72: Ventilation Type

    6.6 Ventilation Type The ventilator provides two ventilation types: invasive and non-invasive. Invasive ventilation is the default ventilation type. 6.6.1 Invasive Ventilation Invasive ventilation means to ventilate the patient through manual airway (endotracheal intubation or tracheostomy). In invasive ventilation, all ventilation modes for adult and pediatric patients are enabled.

  • Page 73: Niv (Non-Invasive Ventilation)

    6.6.2 NIV (non-invasive ventilation) NIV, whose full name is non-invasive ventilation, means to ventilate the patient by using a nasal mask or breathing face mask instead of by endotracheal intubation or tracheostomy. In NIV, all ventilation modes for adult patients and pressure related ventilation modes for pediatric patients are enabled.

  • Page 74: Ventilation Mode

    6.7 Ventilation Mode NOTE  The ventilator creates negative pressure in the expiratory phase due to patient’s active inspiration. There is no limit pressure for negative pressure in the expiratory phase. Instant negative pressure is caused by patient’s active inspiration. In the inspiratory phase, high pressure alarm limit is available.

  • Page 75: Apnea Ventilation

    Set other parameters in the same way. Select [Ok] when parameter setup is completed. Follow these steps to set up ventilation parameters: In the parameter setup quick key field, select the ventilation parameter to be set. Push the control knob and turn it to set the selected parameter to the appropriate value. Push the control knob to confirm the setting.

  • Page 76: Intellicycle

    6.7.3 IntelliCycle IntelliCycle intelligent synchronous technology means to adjust Exp% dynamically by adaptive algorithm through extracting and analysing the feature of the waveforms when Exp% is set to Auto in CPAP/PSV, V-SIMV, P-SIMV and DuoLevel modes. According to the lung properties of the patient, it can adjust Exp% to the best value intelligently to improve the synchronization between the patient and the device, make the patient more comfortable during breathing, reduce the time to adjust the settings during treatment, and reduce the workload of medical staffs and ensure the excellent synchronous effect at the same time.
  • Page 77 [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and expiratory time [f]: Breathing frequency [Flow]: Inspiratory flow [Plimit]: Pressure limitation [Assist]: Assisted trigger [F-Trig] or [P-Trig]: Inspiration trigger level [PEEP]: Positive end-expiratory pressure 10. [△int.PEEP] or [Sigh]: Intermittent positive end-expiratory pressure 11.

  • Page 78: P-A/C

    6.7.5 P-A/C P-A/C is pressure-assist/control ventilation mode. In P-A/C, the airway pressure rises to the preset inspiratory pressure level within the Time of pressure rising and is held at this level until inspiration time is expired. Then expiration is switched to. When the airway pressure is held at the preset inspiratory pressure level, delivered gas flow changes with the resistance and compliance of the patient’s lungs.

  • Page 79: Cpap/Psv

    In P-A/C under NIV, you need to set the following ventilation parameters: [O2%]: Oxygen concentration [Pinsp]: Pressure control level of inspiration [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and expiratory time [f]: Breathing frequency [Tslope]: Time of pressure rising [PEEP]: Positive end-expiratory pressure [Assist]:...
  • Page 80 In CPAP (continuous positive airway pressure ventilation), the airway pressure is held at the user-set positive pressure level throughout the ventilation cycle. The patient breathes spontaneously and determines his own breathing frequency, tidal volume, and breath time. The system starts apnea ventilation when detecting that the period of time when patient does not perform continuous spontaneous breathing exceeds the preset apnea time.

  • Page 81: V-Simv And P-Simv

    [Exp％]: Expiration trigger level [ΔPapnea]: Pressure of apnea ventilation [fapnea]: Frequency of apnea ventilation [Tinsp]: Inspiration time [F-Trig] or [P-Trig]: Inspiration trigger level 6.7.7 V-SIMV and P-SIMV SIMV is designed to guarantee minimum ventilation frequency. Volume control ventilation or pressure control ventilation in SIMV mode is delivered within the trigger window and is delivered automatically at the end of the trigger window if not triggered within the trigger window.
  • Page 82 SIMV+PSV SIMV cycle SIMV cycle Trigger Trigger Trigger Pressure Pressure window window window control control ? Psupp Insp. trigger Time Flow Time In V-SIMV under non-NIV, you need to set the following ventilation parameters: [O2%]: Oxygen concentration [TV]: Tidal volume [Tinsp]: Time of inspiration [fSIMV]:...
  • Page 83 [fSIMV]: Frequency of SIMV [Flow]: Inspiratory flow [Plimit]: Pressure limitation [PEEP]: Positive end-expiratory pressure [Exp％]: Expiration trigger level [△Psupp]: Pressure support level 10. [Tslope]: Time of pressure rising 11. [F-Trig] or [P-Trig]: Inspiration trigger level 12. [fapnea]: Frequency of apnea ventilation 13.

  • Page 84: Prvc

    [△Psupp]: Pressure support level [fapnea]: Frequency of apnea ventilation 10. [F-Trig] or [P-Trig]: Inspiration trigger level 11. [Apnea Vent]: Apnea ventilation switch 6.7.8 PRVC PRVC implements volume control by way of pressure control ventilation. In PRVC, a relatively low pressure level is held as much as possible during the inspiratory phase and the gas volume delivered is guaranteed to be equal to the set tidal volume.
  • Page 85 [f]: Breathing frequency [Tslope]: Time of pressure rising [PEEP]: Positive end-expiratory pressure [Assist]: Assisted trigger [F-Trig] or [P-Trig]: Inspiration trigger level 9. [ATRC]: Automatic tube resistance compensation In PRVC under NIV, you need to set the following ventilation parameters: [O2%]: Oxygen concentration [TV]: Tidal volume...

  • Page 86: Duolevel

    6.7.9 DuoLevel DuoLevel is double level positive airway pressure ventilation. In DuoLevel, the ventilator delivers positive airway pressure at two pressure levels alternatively during mechanical ventilation or spontaneous breathing. The patient can breathe spontaneously at either pressure level. During the low pressure phase, pressure support can be set. Trigger window is available during both high and low pressure phases.

  • Page 87: Aprv

    In DuoLevel under NIV, you need to set the following ventilation parameters: [O2%]: Oxygen concentration [Phigh]: High pressure [Thigh]: Time of high pressure [Plow]: Low pressure [Tlow]: Time of low pressure [Tslope]: Time of pressure rising [Exp％]: Expiration trigger level [△Psupp]: Pressure support level [ΔPapnea]:...

  • Page 88: Change Alarm Limits

    [Tslope]: Time of pressure rising [ΔPapnea]: Pressure of apnea ventilation [fapnea]: Frequency of apnea ventilation 9. [ATRC]: Automatic tube resistance compensation In APRV under NIV, you need to set the following ventilation parameters: [O2%]: Oxygen concentration [Phigh]: High pressure [Thigh]: Time of high pressure [Plow]: Low pressure...

  • Page 89: Ventilation Parameters Monitoring

    6.10 Ventilation Parameters Monitoring WARNING  As required by the relevant rules and regulations, oxygen concentration should be monitored when the equipment is used on the patient. If your ventilator is not configured with such monitoring function or this function is turned off, use a monitor which complies with the relevant international rules and regulations for oxygen concentration monitoring.
  • Page 90 ΔPsupp The pressure support level in pressure support mode and is relative to PEEP or Plow. Tslope Controls pressure rise slope in pressure mode. The number of mechanically controlled breaths delivered to the patient in one minute. fapnea Breathing frequency set in apnea ventilation mode. fSIMV Breathing frequency set in SIMV mode.

  • Page 91: Enter Standby

    The expired tidal volume in one cycle. TVe/IBW The expired tidal volume in one cycle per IBW. TVe spn The spontaneous expired tidal volume in one cycle. The accumulated expired tidal volume in one minute. MVspn The accumulated spontaneous expired tidal volume in one minute. The accumulated leakage (inspiratory volume minus expiratory volume) in one MVleak minute.
  • Page 92 FOR YOUR NOTES 6-24...

  • Page 93: Co2 Monitoring

    CO2 Monitoring 7.1 Introduction CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient’s airway by measuring the absorption of infrared (IR) light of specific wavelengths. The CO2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO2.

  • Page 94: Prepare To Measure Co2

    NOTE As required by the relevant rules and regulations, carbon dioxide concentration  should be monitored when the equipment is used on the patient. If your ventilator is not configured with such monitoring function, use a monitor which complies with the relevant international rules and regulations for carbon dioxide concentration monitoring.

  • Page 95: Make Co2 Settings

    NOTE To extend the lifetime of the water trap and CO2 module, disconnect the water  trap and set the working mode of the module to standby when CO2 monitoring is not required. The CO2 measurement can be used, with specified accessories, with intubated and ...

  • Page 96: Set Working Mode

    7.3.1 Set Working Mode The default working mode of the CO2 module is [Measure] when the ventilator is turned on for the first time. If the current CO2 module is Standby, push the Menu key. Select [System] and then [CO2]. Set [Working Mode] to [Measure] to start the CO2 module. When the ventilator restarts, the CO2 module automatically continues with the previously selected working mode.

  • Page 97: Set Humidity Compensation

    7.3.4 Set Humidity Compensation The CO2 module is configured to compensate CO2 readings for either Body Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or Ambient Temperature and Pressure, Dry Gas (ATPD).   mmHg ATPD: ...

  • Page 98: Troubleshooting

    7.5 Troubleshooting When the sampling system of the CO2 module works incorrectly, check if the sampling line is kinked. If not, remove the sampling line from the water trap. Then, if a prompt message indicating airway malfunction appears on the screen, it means that the water trap is occluded. In this case, you must replace the water trap.

  • Page 99: Special Functions

    Special Functions 8.1 Manual Breath Push the Manual Breath key and the ventilator system delivers one breath to the patient in accordance with the current ventilation mode. NOTE Pressing the Manual Breath key during inspiratory phase cannot initiate a manual ...

  • Page 100: Inspiration Hold

    8.3 Inspiration Hold Inspiration Hold means to extend the patient’s time of inspiratory phase manually and to prevent the patient from expiration for a certain period of time. Push and hold the Insp. Hold key. The ventilator starts the Inspiration Hold function and the screen shows [Insp.

  • Page 101: Suction

    NOTE Nebulization may cause fluctuation in the patient’s FiO2.  8.5 O2↑ The O2↑function means to deliver oxygen with concentration higher than the normal level. When the O2↑key is pushed, the ventilator starts the O2↑ function. The O2↑indicator lamp is illuminated and the screen prompt message filed displays the remaining O2↑ time. O2↑...

  • Page 102: P0.1

    8.7 P0.1 P0.1 is the pressure drop within the first 100 ms after a patient starts spontaneous breathing. Push the Menu key. Select [Tool] and select [Procedure]. Select [P0.1] to access the P0.1 measure screen. Select [Start]. The system starts P0.1 measurement and prompts [Measurement Active].

  • Page 103: Peepi

    8.9 PEEPi The PEEPi measure function supports measurement of two parameters—PEEPi and Vtrap. PEEPi is the positive end-expiratory pressure produced by the trapped gas and Vtrap is the trapped gas volume. Push the Menu key. Select [Tool] and select [Procedure]. Select [PEEPi] to access the PEEPi measure screen.
  • Page 104 The typical ventilation curves with static P-V tool function are shown below: Pressure Pmax PEEP adjusted to PEEP Pstart Time Exp. time Insp. time Flow Expiration at constant flow Gas delivered Time at constant flow The typical static P-V loop is as shown below: Turning point in Volume expiration...
  • Page 105 NOTE  The P-V tool function is disabled in the following cases: patient type of Ped, CPAP/PSV, NIV or apnea vent mode, within one minute after nebulization or suction, within one minute after last P-V loop test. The P-V tool function is not recommended when there is great leakge or when the ...
  • Page 106 After the measurement is completed, the system enters Analysis screen. Characteristic points are displayed automatically on the P-V loop. You can set the desired positions of [Cursor 1] and [Cursor 2]. When you select [Cursor 1] or [Cursor 2], the selected cursor turns red.

  • Page 107: Alarms

    Alarms 9.1 Introduction Alarms, triggered by a vital sign that appears abnormal or by technical problems of the ventilator, are indicated to the user by visual and audible alarm indications. NOTE When the ventilator is started, the system detects whether audible alarm tones and ...

  • Page 108: Alarm Levels

    9.3 Alarm Levels By severity, the ventilator’s alarms fall into three categories: high level alarms, medium level alarms and low level alarms. High level alarms Indicates that the patient is in a life threatening situation and an emergency treatment is demanded.

  • Page 109: Audible Alarm Tones

    9.4.2 Audible Alarm Tones The ventilator uses different alarm tone patterns to match the alarm level:  High level alarms: broadcasts the high level alarm sound.  Medium level alarms: broadcasts the medium level alarm sound.  Low level alarms: broadcasts the low level alarm sound.

  • Page 110: Alarm Status Symbol

    9.4.5 Alarm Status Symbol Apart from the aforementioned alarm indicators, the ventilator still uses the following symbols telling the alarm status:  indicates alarm silenced.  indicates multiple alarm messages. The alarm message uses a different background color to match the alarm level. Red background means that the highest level of the multiple alarm messages is high while yellow background means that the highest level of the multiple alarm messages is medium.

  • Page 111: Set Apnea Time

    9.7 Set Apnea Time Push the Alarm Setup key and select [Alarm Limits]. Set Tapnea to an appropriate value. If no breathing activity is detected longer than the set Tapnea, an apnea alarm is triggered. 9.8 Alarm Silence 9.8.1 How to Set Alarm Silence Push the Alarm Silence key to silence alarm audio of an active alarm for 120 seconds.

  • Page 112: Alarm Reset

    9.9 Alarm Reset Latching alarms: the system continues displaying the alarm message even if the alarm conditions end except that:  Alarm audio disappears;  Alarm LED stops flashing and is permanently lit with the same color;  Alarm message is displayed without background color; ...

  • Page 113: Alarm Test

    [Continuous]: indicates that the nurse call signal lasts until the alarm ends, i.e. the  duration of a nurse call signal equals to that of the alarm. Select [Contact Type] and toggle between [Normally Open] and [Normally Closed].  [Normally Open]: normally open signals are used to trigger the nurse call function. [Normally Closed]: normally closed signals are used to trigger the nurse call ...

  • Page 114: Paw Too High Alarm

    Connect the test lung to the ventilator, and start the ventilation normally. For the ventilator configured with one battery, the battery capacity is depleted after 90 minutes’ ventilation (for the ventilator configured with two batteries, the battery capacity is depleted after 180 minutes’ ventilation). [System DOWN for battery depletion!] alarm is triggered.

  • Page 115: Air Supply Pressure Low Alarm

    9.11.7 Air Supply Pressure Low Alarm Connect high pressure O2 supply and air supply to the ventilator. After the ventilation is normal, close the high pressure air supply, and check if [Air Supply Pressure Low] alarm is triggered. 9.11.8 Airway Obstructed Alarm After the system is powered on normally, connect the test lung to the ventilator and start ventilation.

  • Page 116: Etco2 Too Low Alarm

    After the CO2 test module finishes the preheating and enters in the working status, connect the CO2 of 3% to 7% to the simple port of the sidestream CO2 module or the airway adapter of the mainstream CO2 module. Set the EtCO2 high alarm limit to be lower than the concentration of the standard gas.

  • Page 117: When An Alarm Occurs

    9.13 When an Alarm Occurs When an alarm occurs, do as follows: Check the patient’s condition. Determine the alarming parameter or alarm category. Identify the alarm source. Take proper actions to eliminate the alarm condition. Make sure the alarm condition is corrected. For details about how to troubleshoot alarms, refer to D Alarm Messages.
  • Page 118 FOR YOUR NOTES 9-12...

  • Page 119: Cleaning And Disinfection

    Cleaning and Disinfection WARNING  Obey applicable safety precautions.  Read the material safety data sheet for each cleaning agent.  Read the operation and service instructions for all disinfection equipment.  Wear gloves and safety glasses. A damaged O sensor can leak and cause burns (contains potassium hydroxide).

  • Page 120: Methods For Cleaning And Disinfection

    NOTE  Do not permit liquid to go into the equipment housings.  Only autoclave parts marked 134ºC.  Cleaning solutions must have a pH of 7.0 to 10.5.  The expiration valve assembly and patient hose of the gas pathways through the ventilator can become contaminated with body fluids and expired gases during both NORMAL CONDITION and SINGLE FAULT CONDITION.
  • Page 121 Patient hose Patient hose (including water trap Each patient/weekly ② B* or C* and Y piece) Compressor Housing Each patient A* or D* ① Every 250 hours/as Filter at air intake vent ② necessary* Other Refer to the cleaning and disinfection Nebulizer Each patient/weekly methods provided by the nebulizer...

  • Page 122: Disassemble The Ventilator's Cleanable Parts

    10.2 Disassemble the Ventilator’s Cleanable Parts 10.2.1 Expiration Valve Assembly A. Expiration valve locker knob Expiration valve assembly  To disassemble the expiration valve assembly: Push the expiration valve locker knob toward the inspiratory port and then pull out the expiration valve assembly with force.

  • Page 123: Expiration Valve Flow Sensor

    10.2.2 Expiration Valve Flow Sensor A. Flow sensor  To disassemble the flow sensor: Pull out the flow sensor horizontally from the expiration valve assembly.  To install the flow sensor: Insert the flow sensor horizontally into the expiration valve assembly in the direction as the arrow shows.

  • Page 124: Water Trap

    10.2.3 Water Trap A. Water trap on the breathing hose Water trap on the expiration valve assembly  To disassemble the water trap: Rotate the water trap gently to take it out.  To install the water trap: Rotate to push in the water trap upward. Ensure that the water trap is installed in place. 10-6...

  • Page 125: Breathing Hoses

    10.2.4 Breathing Hoses A. Inspiratory filter Expiratory filter Inspiratory water trap D. Expiratory water trap Support arm hook  To disassemble the breathing hoses: Pull out the breathing hoses one by one.  To install the breathing hoses: Mount the filters onto the inspiratory and expiratory ports. Connect the inspiratory filter to the water trap via the hose.

  • Page 126: Nebulizer

    10.2.5 Nebulizer A. Nebulizer connector Nebulizer hose Nebulizer  To disassemble the nebulizer: Pull out the nebulizer hose from the nebulizer connection. Pull out the nebulizer from the inspiratory hose.  To install the nebulizer: Connect one end of the nebulizer hose to the nebulizer connector and the other end of the hose to the nebulizer.

  • Page 127: Humidifier

    WARNING  Nebulization yields the best performance at flow of 6 L/min. Nebulizers with other flows can create significant errors in tidal volume and oxygen mix. 10.2.6 Humidifier Note Install the humidifier which complies with the specification. The humidifier  assembly and its installation steps described here are only for reference.
  • Page 128 A. Humidifier Humidifier sliding wheel Humidifier bracket fixed seat D. Screw Humidifier inlet Humidifier outlet  To disassemble the humidifier: Remove the hoses connected to the humidifier. Remove the screws. Lift off the humidifier from the humidifier bracket fixed seat. ...
  • Page 129 10.2.6.2 Humidifier Installed onto the Pendant A. Humidifier Knob for fixing block Fixing block D. Humidifier sliding wheel Humidifier bracket fixed seat F. Screw Beam  To disassemble the humidifier: Remove the hoses connected to the humidifier. Remove the screws. Lift off the humidifier from the humidifier bracket fixed seat.

  • Page 130: O2 Sensor

     To install the humidifier: Loosen the knob for fixing block. Put the fixing blocking onto the pendant beam. Tighten the knob for fixing block. Align the humidifier sliding wheel with the humidifier bracket fixed seat and slide in the humidifier.

  • Page 131: Maintenance

    Maintenance 11.1 Repair Policy WARNING Obey infection control and safety procedures. Used equipment may contain blood  and body fluids. Movable parts and removable components may present a pinch or a crush hazard.  Use care when moving or replacing system parts and components. Only use lubricants approved for ventilation or O2 equipment.

  • Page 132: Maintenance Schedule

    11.2 Maintenance Schedule Minimum frequency Maintenance During cleaning and setup Inspect the parts for damage. Replace as necessary. Several times a day or as Check the breathing hoses and water traps for water build-up. Empty necessary water build-up if there is. Daily or as necessary Clean the external surfaces.

  • Page 133: Pressure And Flow Zeroing

    Minimum frequency Maintenance Annually or as necessary Calibrate the inspiration valve and expiratory flow sensor. Calibrate the pressure sensor and expiration valve. Calibrate the CO2 module. Check the check valves, including supply gas check valves, spontaneously inspiratory check valve, and expiratory check valve. Check the mechanical pressure relief valve.

  • Page 134: Flow Sensor Calibration

    11.4 Flow Sensor Calibration NOTE  Do not perform calibration while the unit is connected to a patient. During calibration, do not operate the pneumatic parts. Do not move or press the  breathing hoses especially. Make sure that the system is Standby. If not, push the Standby key to enter ...

  • Page 135: O2 Concentration Calibration

    11.5 O2 Concentration Calibration NOTE  Do not perform O2 concentration calibration while the unit is connected to a patient.  Make sure that the system is Standby. If not, push the Standby key to enter standby screen. Calibrate the O2 sensor when the measured O2 concentration has a great deviation or when the O2 sensor is replaced.

  • Page 136: Co2 Module Calibration

    11.6 CO2 Module Calibration NOTE Make sure that the system is Standby. If not, push the Standby key to enter  standby screen. Prepare the following before doing the calibration:  Gas cylinder: cylinders filled with 3-7% CO2  T-shape connector ...

  • Page 137: Touch Screen Calibration

    11.7 Touch Screen Calibration NOTE  Make sure that the system is Standby. If not, push the Standby key to enter standby screen. Push the Menu key. Select [Calibrate] and select [Touchscreen]. Select [Calibrate] on the right side. mark will appear in different locations of the screen. Click the central point of one by one.

  • Page 138: Battery Use Guidance

    On-screen battery icon indicates the battery statuses as follows:  ： indicates that AC power source is connected. The ventilator is powered by AC power source. The solid portion represents the current charge level of the batteries in proportion to its maximum charge level. ...

  • Page 139: Battery Performance Conditioning

    11.8.2 Battery Performance Conditioning Condition batteries when they are put into use for the first time. A complete battery conditioning cycle is: uninterrupted charging, followed by uninterrupted discharging until the ventilator shuts off, and then uninterrupted charging. Condition batteries regularly to maintain their service life.

  • Page 140: Battery Recycling

    NOTE If the running time of the battery is too short after fully charged, the battery may  be damaged already or defective. If obvious signs of damage are detected on the battery or the battery recharging is  failed, replace the battery and recycle it properly. 11.8.4 Battery Recycling If obvious signs of damage are detected on the battery or the battery recharging is failed, replace the battery and recycle it properly.

  • Page 141: Electrical Safety Inspection Test

    11.9.2 Electrical Safety Inspection Test Perform protective earth resistance test: a. Plug the probes of the analyzer into the protective earth terminal and equipotential terminal of the AC power cord. b. Test the earth resistance with a current of 25 A. c.

  • Page 142: Water Build-Up In The Flow Sensor

    11.10 Water Build-up in the Flow Sensor 11.10.1 Prevent Water Build-up The patient’s exhaled warm and moist gas is condensed all the way when it flows along the expiratory hose. The condensed water remains on the hose wall and finally enters the water trap.

  • Page 143: Accessories

    Accessories WARNING  Use only accessories specified in this chapter. Using other accessories may cause incorrect measured values or equipment malfunction.  Disposable accessories can not be reused. Reuse may degrade performance or cause cross-contamination.  Check the accessories and their packages for damage. Do not use them if any sign of damage is detected.
  • Page 144 Accessories Description Manufacturer Silicone breathing tube, 082-000555-00 Adult, 600mm SAINT-GOBA tube Silicone breathing tube, M6G-020039--- Adult, 450mm Reusable Y type Reusable Y type connector 040-000735-00 VADI Breathing connector (adult) tube L type Reusable L type connector 040-000736-00 VADI kit(adult) connector （115-00 water Reusable water trap(56ml)
  • Page 145 Accessories Description Manufacturer straight Reusable straight connector 040-000742-00 VADI connector water Reusable water trap(30ml) 040-000739-00 VADI trap Disposable breathing tube 040-000755-00 (adult) Disposable Breathing Vincent tube kit medical Disposable breathing tube 040-000756-00 (child) Vincent Filter Disposable filter (round) 040-000757-00 medical Nebulizer Disposable jet nebulizer set 040-000799-00...
  • Page 146 Accessories Description Manufacturer Humidifier(VADI/230V/adu 115-004505-00 VADI lt humidification chamber) Humidifier(VADI/230V/adu 115-004506-00 VADI lt auto-feeding chamber) Humidifier(VADI/230V/ pediatric humidification 115-004507-00 VADI chamber) Humidifier(VADI/115V/adu 115-004508-00 VADI lt humidification chamber) Humidifier(VADI/115V/adu 115-004509-00 VADI lt auto-feeding chamber) Humidifier Humidifier(VADI/115V/ pediatric humidification 115-004510-00 VADI chamber) Humidifier(MR850/230V/ad 115-004511-00 Fisher&Paykel...

  • Page 147: A Theory Of Operation

    Theory of Operation A.1 Pneumatic System A.1.1 Pneumatic Circuit Diagram...
  • Page 148 A.1.2 Parts List Symbol Description Symbol Description Filter at supply gas inlet Three-way valve for F1/F2 SOL2 (O2/Air) expiratory pressure zeroing Pressure switch for supply PS1/PS2 gas pressure monitoring Expiratory pressure sensor (O2/Air) Check valve at supply gas CV1/CV2 Expiration valve inlet (O2/Air) REG1/REG2 Regulator (O2/Air)
  • Page 149 A.1.3 Description This product is pneumatically driven, microprocessor controlled ventilator. As the integration of electronics, pneumatics, mechanics, software and other subjects, the ventilator can partially or fully replace the ventilation function of the patient. During the inspiratory phase, the inspiration valve opens. High pressure Air and O2 supplies enter the ventilator, pass through an Air and O2 mixer, and become fresh gas with specific concentration of O2, and specific flow or pressure.
  • Page 150 Nebulizer control valve (NCV) is a two-way solenoid valve which has two statuses: connected and disconnected. Resistor (R1) is an orifice. When NCV is connected, continuous flow of 6 to 9 L/min is produced. Such flow enters the nebulizer through the connector on the front panel of the ventilator.
  • Page 151 Check valve (CV4) ensures the unidirectional gas flow. When the patient inspires spontaneously, gas goes from the ambient air, through check valve (CV3) of the inspiratory safety module, patient hose, and into the patient’s respiratory tract. At this point, CV4 is closed.

  • Page 152: Electrical System

    A.2 Electrical System A.2.1 Electrical Block Diagram...
  • Page 153 A.2.2 Parts List AC mains input and fuse Motherboard Auxiliary electrical outlet fuse 1 Monitor board Auxiliary electrical outlet fuse 2 Expand board Auxiliary electrical outlet fuse 3 Main control board Auxiliary electrical outlet 3 Lithium battery (two packs) Auxiliary electrical outlet 2 Auxiliary electrical outlet 1 Inverter Main unit AC power socket and fuse...
  • Page 154 FOR YOUR NOTES...

  • Page 155: B Product Specifications

    Product Specifications The ventilator is already integrated with expiratory volume monitor, pressure measurement device, and pressure release device. It has a built-in gas mixer and is equipped with alarm system, O monitor, and CO monitor, where: The expiratory volume monitor, pressure measurement device, and pressure release ...

  • Page 156: Environmental Specifications

    B.2 Environmental Specifications Main unit Item Temperature (ºC) Relative humidity Barometric (non-condensing) pressure (kPa) Operating +10 to +40 15 to 95％ 50 to 106 Storage and transport –20 to +60 (O2 sensor: –20 to +50) 10 to 95％ 50 to 106 B.3 Power Requirements External AC power supply Input voltage...

  • Page 157: Physical Specifications

    B.4 Physical Specifications System noise A-weighted sound pressure level (L ) ≤45 dB(A) System noise A-weighted sound power level (L ) ≤53 dB (A) Main unit 470 x 430 x 500 mm (height x width x depth) (excluding CO module) Dimensions 1340 x 560 x 730 mm (height x width x depth) (excluding hoses) Approximately 25 kg (excluding CO...

  • Page 158: Pneumatic System Specifications

    /calibration One multiplex connector for calibrating inspiratory and expiratory flows connector and supplying power for the external CO analyzer. Nurse call connector Provides digital signals to drive the hospital’s nurse call system. Outputs VGA video signals with the same contents to the primary display VGA connector and connects to the external display.

  • Page 159: Ventilator Specifications

    Not greater than 6 cmH O at 60 L/min flow (adult reusable breathing hose ) Not greater than 6 cmH O at 30 L/min flow (pediatric reusable Expiratory resistance breathing hose ) Not greater than 6 cmH O at 5 L/min flow (infant reusable breathing hose) Resistance: <...
  • Page 160 Plow 0 to 50 Thigh 0.2 to 30 Tlow 0.2 to 30 Trigger 0.5 to 15 L/min -10 to -0.5 △int.PEEP OFF, 1 to 40 Exp% Auto, 10 to 85 △Papnea Provides pressure apnea setting. Refer to Pinsp specification. fapnea Pediatric: 1 to 100 Adult: 1 to 100 Weight...

  • Page 161: Ventilator Accuracy

    P0.1 -20 to 0 PEEPi 0 to 120 15 to 100 ％ B.7 Ventilator Accuracy Control accuracy ±3 vol.% or ±5% of setting, whichever is greater ±10 mL or ±10% of setting, whichever is greater 1 bpm to 100 bpm: ±1 bpm Other range: ±2% of setting fSIMV ±1 bpm...
  • Page 162 0 ml~100 ml: ±（10 ml + 3% of reading） 100 ml~4000 m: ±（5 ml + 8% of reading） ±15% of reading or ±15 mL, whichever is greater (NIV) TVe spn MVspn ±8% of reading or ±0.3 L/min, whichever is greater MVleak ftot fmand...

  • Page 163: Alarms

    B.8 Alarms B.8.1 Settable Alarms Alarm settings Parameter Setting range Automatic threshold Notes High limit 110 to 4000 mL, OFF(Adult) 1.5 × TVe average High limit value is greater 25 to 4000 mL, OFF(Pediatric) than low High limit Pediatric: 0.2 to 60.0 L/min (non-NIV) 1.5 ×...

  • Page 164: Special Functions

    B.9 Special Functions Function Specification Inspiration Push and hold the Insp. Hold key to activate this function. Hold Inspiration Hold is active for a maximum of 30s. Expiration Push and hold the Exp. Hold key to activate this function. Hold Expiration Hold is active for a maximum of 30s.

  • Page 165: Co Module Specifications

    B.10 CO Module Specifications module Measurement range Accuracy 0 to 40 mmHg ±2 mmHg Measurement range and accuracy 41 to 76 mmHg ±5% of reading 77 to 99 mmHg ±10% of reading Resolution 1 mmHg <330ms@100mL/min Rise time <400ms@70mL/min <3s@100mL/min <3.5s@70mL/min Measured by using neonatal water trap and 2.5-meter long neonatal sampling line.

  • Page 166: Compressor Specifications

    B.11 Compressor Specifications Compressor Specifications Input voltage 220 to 240 V 110 to 120 V Input frequency 50/60Hz 60Hz Input current Output pressure range 300 to 450 kPa Noise Less than 50dB (A) Continuous flow ≥30 L/min at output pressure of 300kPa Peak flow Greater than 180 L/min for more than 0.8 seconds at one barometric pressure...
  • Page 167 Effect of interfering gas Gas under test Error (％O 50% He/50% O <1% 80% N O/20% O 1 to 1.5% 4% Halothane/28.8% O /67.2% N 1.5% to 2% 5% Sevoflurane/28.5% O / 66.5% 1 to 1.5% 5% Enflurane/28.5% O /66.5% N 1.2 to 1.8% 1.8% 5% Isoflurane/28.5% O...
  • Page 168 Overall the cell reaction may be represented as:   sensor is current generator, and the current is proportional to the rate of oxygen consumption (Faraday's Law). This current can be measured by connecting a resistor across the output terminals to produce a voltage signal.
  • Page 169 Life = 1192/exp(2+0.0239 Temperature) ） Temperature(°C)） B-15...
  • Page 170 FOR YOUR NOTES B-16...
  • Page 171 SynoVent E5 ventilator is in compliance with IEC 60601-1-2 for EMC. The essential performance verified during the immunity testing comprised of V control accuracy, V monitoring accuracy, monitoring of the airway pressure, CO2 Accuracy and O2 Accuracy. NOTE Using accessories other than those specified may result in increased ...
  • Page 172 Guidance and manufacture’s declaration - electromagnetic emissions The SynoVent E5 ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SynoVent E5 ventilator should assure that it is used in such an environment.
  • Page 173 Guidance and manufacture’s declaration - electromagnetic immunity The SynoVent E5 ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SynoVent E5 ventilator should assure that it is used in such an environment.
  • Page 174 Guidance and Manufacturer’s declaration - electromagnetic immunity The SynoVent E5 ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SynoVent E5 ventilator should assure that it is used in such an environment as described below.
  • Page 175 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SynoVent E5 ventilator is used exceeds the applicable RF compliance level above, the SynoVent E5 ventilator should be observed to verify normal operation.
  • Page 176 The SynoVent E5 ventilator is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the SynoVent E5 ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SynoVent E5 ventilator as recommended below, according to the maximum output power of the communications equipment.

  • Page 177: D Alarm Messages

    Alarm Messages This chapter lists physiological and technical alarm messages. Note that in this chapter: Column P stands for the default alarm level: H for high, M for medium and L for  low. For each alarm message, corresponding actions are given instructing you to ...

  • Page 178: Technical Alarm Messages

    Apnea ventilation Apnea ventilation mode is started when the time of failure to detect respiration exceeds Tapnea. When this alarm is triggered, press [Alarm Reset] key and the alarm disappears. The system returns to the previous ventilation mode. ftot Too High M The total breathing frequency is greater than ftot high alarm limit.
  • Page 179 personnel. RT Clock Need There is button cell available in the system but the clock is Reset reset in case of power failure. Contact your service personnel. RT Clock Not There is no button cell available in the system or the Exist battery has no capacity.
  • Page 180 Air Supply The supply gas pressure is low. Ventilator Pressure Low Check the status of supply gas. If the alarm continues parameters although supply gas is normal, contact your service O2 Supply personnel. Pressure Low No Gas Supply Air supply pressure low and O2 supply pressure low occur Pressure every second simultaneously.
  • Page 181 Check for leakage. Check if the expiratory trigger sensitivity is too low. Ctrl Module Restart the ventilator. If the problem persists, contact your Comm Error service personnel. Ctrl Module Comm Stop Ctrl Module Selftest Error Protection Module Comm Error Protection Module Comm Stop Protection Module Selftest Error...
  • Page 182 Nebulizer Valve M The nebulizer valve is faulty. Restart the ventilator. If the Failure problem persists, contact your service personnel. 3-way Valve M The 3-way valve is faulty. Restart the ventilator. If the Failure problem persists, contact your service personnel. Insp.
  • Page 183 CO2 Low Airway The airway pressure is too low (<428 mmHg).An error Pressure occurred to the airway pressure. Check the patient and pneumatic connections. Attempt to restart the ventilator. O2 High The barometric pressure is greater than 790 mmHg. Barometric Check the pneumatic connections.
  • Page 184 FOR YOUR NOTES...

  • Page 185: E Factory Defaults

    Factory Defaults This chapter lists the most important factory default settings which are not user-adjustable. When necessary, you can restore the factory default settings. E.1 CO2 Module CO2 module Factory default setting Working mode Measure Pump rate 100 mL/min Humidity compensation CO2 calibration concentration setting EtCO2 low limit...

  • Page 186: Ventilation Mode

    E.3 Ventilation Mode Ventilation mode Factory default setting V-A/C Adult: 7 kg/mL x IBW and 100 ml, whichever is greater; pediatric: 7 kg/mL x IBW (round down) (when TV/f source is IBW or height & gender) Adult: 500 ml; pediatric: 50 ml (when TV/f source is patient type) Plimit 40 cmH2O PEEP...
  • Page 187 Adult: 12 bpm; pediatric: 29 bpm ATRC (only in non-NIV mode) CPAP/PSV PEEP 3 cmH2O 0 cmH2O △Psupp Tslope 0.2s F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min Exp% Auto 15 cmH2O △Papnea fapnea Adult: 12 bpm; pediatric: 29 bpm Tinsp (only in NIV mode) Adult: 1.7s;...
  • Page 188 Apnea ventilation ATRC (only in non-NIV mode) Tube diameter (only in 8.0mm non-NIV mode) Compensation proportion (only in non-NIV mode) Compensation of expiration (only in non-NIV mode) P-SIMV fSIMV Adult: 5 bpm; pediatric: 20 bpm Pinsp 15 cmH2O PEEP 3 cmH2O 0 cmH2O △Psupp Tinsp...
  • Page 189 Assist F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min ATRC (only in non-NIV mode) Tube diameter (only in 8.0mm non-NIV mode) Compensation proportion (only in non-NIV mode) Compensation of expiration (only in non-NIV mode) Duolevel 0 cmH2O △Psupp Tslope 0.2s Phigh 15 cmH2O Plow 5 cmH2O...
  • Page 190 15 cmH2O △Papnea fapnea Adult: 12 bpm; pediatric: 29 bpm ATRC (only in non-NIV mode) Tube diameter (only in 8.0mm non-NIV mode) Compensation proportion (only in non-NIV mode) Compensation of expiration (only in non-NIV mode)

  • Page 191: F Symbols And Abbreviations

    Symbols and Abbreviations F.1 Symbols ampere ampere hour Breaths per minute ºC centigrade cubic centimetre centimeter cmH2O centimeter of water decibel ℉ fahrenheit gram hour hertz hectopascal inch inch kilo- kilogram kilopascal litre pound meter milliampere hour mbar millibar milligram minute milliliter millimeter...
  • Page 192 nanometer part per million second volt volt ampere Ω µA microampere µV microvolt watt minus percent per；divide；or ～ power plus ＋ ＝ equal to less than ＜ greater than ＞ less than or equal to ≤ greater than or equal to ≥...

  • Page 193: Abbreviations

    F.2 Abbreviations APRV Airway Pressure Release Ventilation ATPD Ambient Temperature and Pressure Dry BTPS Body Temperature and Pressure Saturated Cdyn Dynamic Compliance CPAP/PSV Continuous Positive Airway Pressure/ Pressure Support Ventilation Cstat Static Compliance DuoLevel Duo Level Ventilation EtCO2 End-tidal Carbon Dioxide FiCO2 Fraction of Inspired Carbon Dioxide FiO2...
  • Page 194 Plimit Pressure Limit Level Pmean Mean Pressure Ppeak Peak Pressure Pplat Plateau Pressure PRVC Pressure Regulated Volume Control Ventilation P-SIMV Pressure - Synchronized Intermittent Mandatory Ventilation △int.PEEP Intermittent Positive End-Expiratory Pressure △Papnea Pressure of Apnea Ventilation (relative to PEEP/Plow) Pressure Support Level(relative to PEEP/Plow) △Psupp Rinsp Inspiration Resistance...
  • Page 196 P/N: 046-000991-00 (10.0)

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