Northern Meditec Crius V6 Operator's Manual
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Northern Meditec Crius V6 Operator's Manual

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Crius V6/V8 Ventilator
Operator's Manual
Northern Meditec Limited

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Summary of Contents for Northern Meditec Crius V6

  • Page 1 Crius V6/V8 Ventilator Operator’s Manual Northern Meditec Limited...
  • Page 2 © 2015-2017 ShenZhen Northern Meditec Limited. All rights Reserved. For this Operator’s Manual, the issue date is Aug, 2022. Operator’s Manual Document No./Version: NR-TP-3162-001/A3.0 Software version: V01.01.07 2 / 182...
  • Page 3 Shenzhen Northern Meditec Limited. (hereinafter referred to as "Northern"). The User’s Manual contains exclusive data under the protection of law of copyright. All rights reserved. Any individual or organization must not reproduce, amend or translate the any part of the User’s Manual without prior written approval from our company.
  • Page 4 Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Northern 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 5 Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. In accordance with the conditions of storage and use, from the date of the factory 18 months, the ventilator can not work properly, the company free of charge for the user repair, replacement parts or products.
  • Page 6 Customer Service Department Manufacturer: Northern Meditec Limited Address: Room 501, 502 Building A, Room 401 Building C, JinWeiYuan Industrial Area, No.41 Qingsong Road, Zhukeng Community, Longtian Sub-district, Pingshan District, 518118 Shenzhen City, P.R. China Website: www.northernmeditec.com E-mail Address: info@northernmeditec.com Tel:...
  • Page 7 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 8: Table Of Contents

    Table of Contents Chapter 1 Safety ............................14 1.1 Safety Information ............................ 14 1.1.1 Dangers ............................14 1.1.2 Warnings ............................14 1.1.3 Cautions ............................17 1.1.4 Notes .............................18 1.2 Equipment Symbols ..........................19 1.3 Symbols and Abbreviations ........................20 1.3.1 Unit ..............................21 1.3.2 Symbols ............................21 1.3.3 Abbreviations ..........................22 Chapter 2 The Basics ..........................25...
  • Page 9 Chapter 4 User Interface ..........................48 4.1 Display Controls ............................48 4.2 System Check Screen ..........................49 4.3 StandBy Screen ............................50 4.4 User Screen .............................. 51 4.5 Measured Values Screen ........................52 4.6 History Data .............................. 53 4.6.1 Tabular Trend ..........................53 4.6.2 Graphic Trend ..........................55 4.6.3 Event Log .............................
  • Page 10 5.17.2 Set Vt ............................64 5.17.3 Set Psupp ...........................64 5.17.4 Set Pinsp ............................ 65 5.17.5 Set Tinsp ............................ 65 5.17.6 Set Rate ............................65 5.17.7 Set Trigger ..........................66 5.17.8 Set Tslope ..........................66 5.17.9 Set Phigh ............................66 5.17.10 Set Plow ........................... 67 5.17.11 Set Thigh ..........................
  • Page 11 7.1 Summary ..............................88 7.2 Monitoring ways ............................88 7.2.1 Main stream ..........................88 7.2.2 Side stream ..........................90 7.2.3 Set CO2 ............................91 7.3 Mainstream CO2 module ........................91 7.3.1 Installation ............................ 91 7.3.2 Checking before using ....................... 93 7.3.3 Affecting factors of monitoring ....................93 7.3.4 Monitor calibration ........................
  • Page 12 10.4 Set Alarm Volume ..........................108 10.5 Set Alarm Limits ........................... 109 10.6 Alarm Tests ............................109 10.6.1 Loss of Power ..........................109 10.6.2 Paw Too High .......................... 109 10.6.3 Paw Too Low ........................... 110 10.6.4 VTi Too High ..........................110 10.6.5 MVe Too High ..........................110 10.6.6 MVe Too Low ..........................
  • Page 13 12.9 Battery Maintenance ..........................138 12.9.1 Battery Performance Conditioning ..................139 12.9.2 Battery Performance Checking .................... 140 12.9.3 Battery Storage ........................141 12.9.4 Battery Recycling ........................141 12.9.5 Disposing ..........................141 12.10 Electrical Safety Inspection ......................142 12.11 Water Build-up in the Flow Sensor ....................143 12.11.1 Prevent Water Build-up ......................

  • Page 14: Chapter 1 Safety

    Chapter 1 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.
  • Page 15 conductor, disconnect it from the power line. Use external power source (AC power or DC power) before the batteries are depleted.  To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetic  agent, vapors or liquids. When O2 is used, keep the ventilator away from any fire sources. Do not place the ventilator adjacent to any barrier, which can prevent cold air from flowing, ...
  • Page 16 personnel who are responsible for connecting the optional equipment to the I/O signal port shall be responsible for medical system configuration and system compliance with IEC 60601-1 as well. Do not touch the patient when connecting the peripheral equipment via the I/O signal ports or ...

  • Page 17: Cautions

    When operating the unit with the power supply unit, always connect the unit to an easily accessible  outlet so that it can be unplugged quickly in the event of a malfunction. No modification of this equipment is allowed.  Failure to have an alternative means of ventilation such as a self-inflating, manually-powered ...

  • Page 18: Notes

    the power line are the same as those indicated on the equipment’s label or specified in this manual. Always install or carry the equipment properly to avoid damage caused by dropping down, impact,  strong vibration or other mechanical force. To electrically isolate the ventilator circuits from all poles of the supply mains simultaneously, ...

  • Page 19: Equipment Symbols

    NOTE Put the ventilator and its accessories 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 62304.

  • Page 20: Symbols And Abbreviations

    Symbol Symbol Meaning Meaning Type BF applied part. MR Unsafe - do not subject to Defibrillation-proof protection magnetic resonance imaging (MRI) against electric shock. The EU Representative Stacking limit by number Office Temperature limitation Humidity limitation Atmospheric pressure This way up limitation Fragile, handle with care Keep dry...

  • Page 21: Unit

    1.3.1 Unit centimeter of water milliwatt hectopascal nanometer ampere part per million ampere hour second breaths per minute volt ºC millisecond centigrade cubic centimetre millivolt centimeter liter decibel pound fahrenheit meter ℉ gram milliampere hour hour cmH2O millibar hertz milligram inch inch minute...

  • Page 22: Abbreviations

    ≤ less than or equal to ≥ greater than or equal to ± plus or minus multiply © copyright 1.3.3 Abbreviations Abbreviations Meaning awRR Air Way Respiration Rate Patient inspiration flow Patient expiration flow Resuscitation Sensitivity Level Automatic intubation compensation APRV Airway pressure release ventilation Spontaneous breathing at continuous positive airway pressure with...
  • Page 23 VT Apnoea Setting for tidal volume of apnoea ventilation VT ASB Inspiratory breathing volume of apnoea ventilation Expiratory tidal volume Inspiratory tidal volume Vreap Volume trapped in the lung by intrinsic PEEP,and exhaled during subsequent expiration. EtCO2 End-expiratory CO2 concentration Rate Frequency Rateapnoea...
  • Page 24 Pplat End-inspiratory airway pressure Ressistance Rapid Shallow Breathing Quotient of spontaneous breathing frequency and tidal volume SIMV Synchronized Intermittent Mandatory Ventilation Thigh Time for the upper pressure level in APRV Tinsp Set value of the inspiratory time Tlow Time for the lower pressure level in APRV Adult Pediatric Infant...

  • Page 25: Chapter 2 The Basics

    The maximum working pressure is ensured by the high pressure alarm limit. Gas supply and delivery The Crius V6/Crius V8 uses room air and low- or high-pressure oxygen (Figure 1-1). Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high1- or low-pressure2 inlet.
  • Page 26 The microprocessor controls the size of the inspiratory valve opening and the length of time it is open to meet the user settings. The Crius V6/Crius V8 delivers gas to the patient through the inspiratory limb breathing circuit parts, which may include an inspiratory filter, flex tubes, the humidification system, water traps, the Y-piece, and the Flow Sensor.

  • Page 27: Intended Use

    Patient populations: Adults, pediatric patients and neonates. 2.1.5 Environment of use The Crius V6/Crius V8 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital. Do not use the device in the following environments: –...

  • Page 28: Side-Effect

     safety. The user must monitor the patient continuously. If the Crius V6/Crius V8 is equipped with a transfer feed and is used at an inclination of >5°, there  is a risk of tipping over. On the inclined plane, the equipment combination must be arranged so that the transfer supply device is always at the upper end.

  • Page 29: Components

    Ventilation-perfusion mismatch Reduced compliance Skin injury Facial flattening Maxillary retrusion Dry throat Nasal bridge sores 2.1.7 Components The ventilator consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, software, display, CO module), trolley, and support arm. Connect the patient to the ventilator via the patient breathing circuit. The applied part of the ventilator is breathing masks.
  • Page 30 ventilator from personnel authorized manufacturer. - Has appropriate knowledge and experience about installing and maintaining similar device. Permissible impairments - Mild reading vision impairment or best-corrected visual acuity to log MAR 0.5 (6/19 or 20/63) or better. - Impaired by 40% resulting in 60% of normal hearing at 50 Hz to 2 kHz.

  • Page 31: Equipment Appearance

    2.2. Equipment Appearance 2.2.1 Front View Crius V6 Crius V8 31 / 182...
  • Page 32 1. Caster and brake:The ventilator has four casters and all casters have brakes. 2. Humidifier 3. Expiratory water trap:Collects condensed water in the expiratory tube. 4. Inspiratory water trap:Collects condensed water in the inspiratory tube. 5. Test lung 6. Inspiratory tube 7.

  • Page 33: Rear View

    2.2.2 Rear View Crius V6 1.Inlet of low-pressure O2 supply 2.Inlet of high-pressure O2 supply 3.AC power receptacle 4.Hang the power cord 5. Main unit air inlet grille : Air intake dust filter and Oxygen sensor. 6.Fan 7. VGA connector:Outputs VGA video signals with the same contents to the primary display and connects to the external display (supporting display with resolution of 1366 x 768).
  • Page 34 Crius V8 1.Inlet of low-pressure O supply 2. Inlet of high-pressure O supply 3.AC power receptacle 4.Trolley 5.Main unit air inlet grille :Air intake dust filter and Oxygen sensor. 6.Fan 7.RS-232 connector :Connects to the external calibration device for calibrating pressure. An external medical device can be connected via this connector to communicate with the ventilator.

  • Page 35: Chapter 3 Installations And Connections

    Adding accessories or other components to the breathing system of the ventilator can increase  system inspiratory and expiratory resistance. 3.1 Install the Main Unit Crius V6 35 / 182...
  • Page 36 Crius V8 Main unit B.Positioning post C.Trolley unlocking button Trolley Align the main unit with the two positioning posts on the trolley and put it onto the trolley in place. To remove the main unit from the trolley, depress the trolley unlocking button and then lift it 36 / 182...

  • Page 37: Connect To The Power Supply

    3.2 Connect to the Power Supply 3.2.1 Connect to AC Power Crius V6 Crius V8 A-AC power receptacle B-AC power cord Insert the AC power cord into the AC power receptacle. 37 / 182...

  • Page 38: Connect To The Gas Supply

    3.3 Connect to the Gas Supply Crius V6 Crius V8 A. High-pressure O supply connector B. High-pressure O supply hose and fitting C. Low-pressure O supply connector D. Low-pressure O supply hose This ventilator provides two types of gas supply connection: high-pressure O...

  • Page 39: Install The Support Arm

    Check if the sealing ring at the gas supply connection is in good condition before connecting the gas supply hose. If the sealing ring is damaged, do not use the hose. Replace the sealing ring to prevent leakage. Align the connector with and insert it into the inlet of high-pressure O supply at the rear of the ventilator.
  • Page 40 Crius V6 Crius V8 Fixing block knob B. Fixing block C. Tube hook Support arm joint E. Support bar F. Support arm joint Support arm joint 1. Loosen the fixing block knob. Place the fixing block onto the handle on the side of the ventilator.

  • Page 41: Install The Patient Tubing

    3. Adjust the support arm. 4. Place the patient tubing onto the tube hook. WARNING To prevent possible patient injury due to accidental extubation, check the support arm joints and  the connection security as necessary. NOTE Operate support arm joint F or G with both hands as shown below. Operating with a single hand will ...
  • Page 42 Crius V6 Crius V8 A. Inspiratory filter B. Expiratory filter C. Inspiratory water trap D. Expiratory water trap E. Simulation of lung F. Support arm book Connect the patient to the ventilator via the patient breathing circuit. 42 / 182...

  • Page 43: Install Neonate Tubing

    4. Connect the patient side of the Y piece to the HME and then connect the HME to the patient. 5. Place the patient tubing onto the support arm hook. 3.5.2 Install Neonate Tubing The use of a VHB10A humidifier is recommended when installing neonate tubing. Crius V6 43 / 182...
  • Page 44 Crius V8 Neonatal flow sensor tubing connector Neonatal flow sensor C. Neonatal flow sensor tubing D. Neonatal humidifier E. Neonatal water trap (Inspiratory and Expiratory one each) F. Neonatal test lung 1. Mount the filters onto the inspiratory and expiratory ports. 2.

  • Page 45: Install The Humidifier

    NOTE The humidifier shall comply with the requirements of ISO 8185. The humidifier assembly and its  installation steps described in this section are only for reference. 3.6.1 Install the Humidifier onto the Ventilator Crius V6 45 / 182...
  • Page 46 Crius V8 A. Humidifier B. Humidifier bracket slot C. Humidifier inlet D. Humidifier outlet E. Humidifier mounting plate 1. Align the humidifier mounting plate and the slot, and slide the humidifier in. 2. Tighten the screw. 3. Mount the filters onto the inspiratory and expiratory ports. 4.

  • Page 47: Install The O Sensor

    3.7 Install the O Sensor CAUTION To reduce the risk of explosion, do not burn the O2 cell or force the cell open.  Crius V6 Crius V8 A. Main unit air inlet grille B. O sensor C. O sensor connection cable 1.

  • Page 48: Chapter 4 User Interface

    Chapter 4 User Interface 4.1 Display Controls Crius V6 Crius V8 The control unit is characterized by a small number of operating elements. Its main elements are: Alarm indicator A group of red / yellow color, and includes a translucent lens LED. Provide visual alarm information through different color and different flicker frequency.

  • Page 49: System Check Screen

     Extinct: Ventilator is not connecting AC. Running indicator  Bright: start system.  Extinct: system shutdown Up key Alternate user operation key, press this button, the cursor moves upward. Enter key Alternate user operation key, press this button for confirmation. Down key Alternate user operation key, press this key to move the cursor down.

  • Page 50: Standby Screen

    Click the [Skip] button, jump self-test interface, directly into the standby interface. Click the [Continue] button to enter the self-test function. Note Crius V6/Crius V8 difference, interface display and menu name area is different, but the function  is the same.

  • Page 51: User Screen

    Note Crius V6/Crius V8 difference, interface display and menu name area is different, but the function is  the same. 4.4 User Screen 1. Soft key display area: alarm, 100% O Suction,Nebulizer(Function not used) , tools, freeze, lock and menu.

  • Page 52: Measured Values Screen

    14. Ventilation mode area: display the current ventilation mode. 15. Ventilation type display area: invasive or non-invasive ventilation is displayed. Note Crius V6/Crius V8 difference, interface display and menu name area is different, but the function is  the same.

  • Page 53: History Data

    4.6 History Data Select the [Menu], select the [Data] button to access the window as shown below. You can view tabular trend, graphic trend, and event logbook in the History window. 4.6.1 Tabular Trend You can view the patient’s monitored parameter data and events under the Tabular Trend tab. Trend data displays at one-second intervals by default.
  • Page 54 4.6.1.1 Navigating in Tabular Trend Button Function Moves the cursor one record back/forward from its current position. Moves the cursor to the top/bottom parameter from its current position. Moves the cursor up/down one page from its current position. Previous Event Moves the cursor to the previous event from its current position.

  • Page 55: Graphic Trend

     Tabular Trend is not stored when the machine is in standby status.  The system can display a rolling 24 hours of continuous trend data. 4.6.1.3 Interval In the Tabular Trend window, you can set [Interval] to [1s], [5s], [1min], [10min], [30min], and [1h]. 4.6.2 Graphic Trend A trend graph is used to review the trend of parameter values within a specific time period.

  • Page 56: Event Log

    4.6.2.2 Navigating in Graphic Trend Button Function Moves the cursor one page back/forward from its current position. Moves the cursor up/down one parameter from its current position. Previous Event Moves the cursor to the previous event from its current position. Next Event Moves the cursor to the next event from its current position.

  • Page 57: Big Font Screen

    4.6.3.1 About Event Log  Event Logbook displays the most recent record at the top.  The system can store up to 5000 records of Event Logbook. NOTE The system can store up to 5000 records of Event Logbook. When a new event occurs ...

  • Page 58: Big Loop Screen

    4.8 Big Loop Screen Click the bottom [Menu] -> [System setup] -> [setting], Flyout: select [Big Loop], as shown below: 4.9 Freeze The freeze function’s feature is that it can pause the real-time refreshing of waveforms and spirometry loops on the screen, so that you can have a close examination of the patient’s status within this time 58 / 182...

  • Page 59: Enter Freeze Status

    period. The reviewed data are waveforms and spirometry loops in the 30 seconds before entering freeze state. 4.9.1 Enter freeze status During ventilation, press the [Freeze] key and the [Freeze Active. Press the Freeze key to Unfreeze] prompt message is displayed on the screen. The system enters freeze status. All displayed waves and loops are frozen, namely, they are not refreshed.

  • Page 60: Chapter 5 System Settings

    Chapter 5 System Settings 5.1 Display Settings 5.1.1 Interface Select [Menu]→[System Setting]→[Setting]. Set [Layout] as required to select the type of interface you want to display. 【Normal】: Display the main interface.  【Big Font】: Display large font interface.  [All Params]: display the full parameter monitoring interface. ...

  • Page 61: Ibw/Height

    5.3 IBW/Height Select [Menu]→[System setup]→[Setting]. Select [IBW/Height]: [IBW] and [Height]. VT/IBW.select 6~8mL/Kg. 5.4 Adjust Screen Brightness Select [Menu]→[System setup]→[Setting]. Select [Day] or [Night] to choose the corresponding default screen brightness. On the screen backlight brightness setting, select [Menu] → [System Setup] → [Other]. 【Day】...

  • Page 62: Screen Calibration

    5.8 Screen Calibration Select [Menu]→ [System setup] →[Other]. Click the [Cal.Touchscreen] button to enter the screen calibration interface, click the prompt order, and finally select [OK] button. 5.9 Defaults Select [Menu]→ [System setup] →[Other]. Set [Defaults] as required to restore the setting alarm delay, alarm vol and backlight to the default values.

  • Page 63: Set Mexico Logo Switch

    5.13 Set Mexico Logo Switch Select [Menu]→ [Factory setting] →enter the required password→[Setting setup]. Select [Mexico Logo Switch] among off and on. [OFF]: Mexico Logo switch stop working.  [On]: Mexico Logo switch start working.  5.14 Module setup 5.14.1 Set CO module Select [Menu]→...

  • Page 64: Set Co Suffocation

    Compen】: 【Low】, 【Mid】, 【High】, the default is 【Low】. 【O 5.15.4 Set CO suffocation Select [Menu] → [System setup] → [CO module]. 【Apnea Delay】: 【20s】, 【25s】, 【30s】, 【35s】, 【40s】, the default is 【20s】. 5.16 Select mode Calibration Select [Menu]→ [Factory setting] →enter the required password→[Calibration]. Select [Calibration mode] among [O Sensor], [Insp.

  • Page 65: Set Pinsp

    Select【SIMV】, 【MMV】, 【BIPAP】or 【CPAP】->【Psupp】soft key. Popup the prompt setting window, use your finger press the frame and slide to the right，the value gradually increase; slide to the left，the value gradually reduce; or long press【 】and no release， the value gradually increase; long press【 】and no release，the value gradually reduce;...

  • Page 66: Set Trigger

    can press【 】release，the value increase or reduce one step length. Set【Rate】to the 】or【 appropriate value. Press【 】to confirm your setting take effect; press【 】cancel setting and not take effect. 5.17.7Set Trigger Select【IPPV】, 【SIMV】, 【MMV】, 【BIPAP】, 【CPAP】->【Trigger】soft key. Popup the prompt setting window, use your finger press the frame and slide to the right，the value gradually increase;...

  • Page 67: Set Plow

    Press【 】to confirm your setting take effect; press【 】cancel setting and not take effect. 5.17.10 Set Plow Select【APRV】->【Plow】soft key. Popup the prompt setting window, use your finger press the frame and slide to the right，the value gradually increase; slide to the left，the value gradually reduce; or long press【 】and no release，...

  • Page 68: Set Flow

    Popup the prompt setting window, use your finger press the frame and slide to the right，the value gradually increase; slide to the left，the value gradually reduce; or long press【 】and no release， the value gradually increase; long press【 】and no release，the value gradually reduce; also you can press【...

  • Page 69: Restore Factory Default Settings

    during ventilation and save the changed settings as default settings. There are two groups of default settings, adult and pediatric. Recent settings. In actual applications, you may change some settings, which, however, may not be  saved as current settings. The ventilator stores these settings in real time. The stored settings are recent settings.

  • Page 70: Chapter 6 Ventilation

    Chapter 6 Ventilation 6.1 Turn on the System Insert the power cord into the power receptacle. Ensure the external power indicator light is lit. Press the key. The alarm indicator light flashes yellow and red once in turn, and then the speaker and the buzzer give a check sound respectively.
  • Page 71 system check information of the ventilator system, including system check items, System Check results, and System Check time. Connect the gas supply and block the Y piece as illustrated. Then select [Continue] to start System Check item by item. System Check items include: Hardware Voltage ...

  • Page 72: Select Patient

    the system stops the check of the current item and also the check of the remaining items immediately, and displays [Cancel] as the check result. When O sensor test fails, the [O Calibration] button is displayed. Press this button to open the O calibration menu, and then to calibrate oxygen concentration.

  • Page 73: Non-Invasive Ventilation (Niv)

    6.4.2 Non-invasive Ventilation (NIV) NIV means to ventilate the patient by using a nasal mask or facial mask instead of ET tube or Trach tube. In NIV, the enabled ventilation modes include:IPPV,SIMV,BIPAP,APRV,MMV,CPAP in adult, pediatric and neo patient ranges. The disabled ventilation modes in NIV appear grey. The leakage compensation in non-invasive ventilation: The non-invasive ventilation is enabled only in pressure control ventilation mode.

  • Page 74: Ventilation Mode And Parameter Setup

    6.5.1 Ventilation Mode and Parameter Setup Ventilation mode setup field Displays all the keys for setting up ventilation modes. The ventilator can be configured with the following ventilation modes: IPPV,SIMV,BIPAP,APRV,MMV,CPAP, IPPV,SIMV,BIPAP,APRV,MMV,CPAP. Additional parameters can be selected depending on the mode.If Trigger is selected for the IPPV changed is IPPV Assist mode.

  • Page 75: Ippv

    Pinsp √ √ √ Tinsp √ √ √ Rate √ √ √ Trigger √ √ Tslope √ √ √ √ √ Psupp √ √ √ √ Phigh √ Plow √ Thigh √ Tlow √ Other ventilation Settings: Ventilation modes can be used in conjunction with additional Settings to optimize ventilation the table shows the additional Settings available and the corresponding parameters for each ventilation mode.

  • Page 76: Simv, Simv/Asb

    For patients having no spontaneous breathing. Set the pattern of ventilation for IPPV with the ventilation parameters: [VT]:Tidal volume [Flow]:Insp.Flow [Rate]:Frequency [Tinsp]:Inspiration [O2]:O2 concentration [PEEP]:Positive end-expiratory pressure [Pmax]:Pressure Limited Ventilation IPPV can be expanded by the following ventilation parameters: Trigger (IPPV Assist) – for synchronisation with attempted spontaneous breathing by the patient.By switching on the flow trigger and setting the trigger level, the mandatory strokes are synchronised with the patient's spontaneous breathing attempts.
  • Page 77 Synchronized Intermittent Mandatory Ventilation*Assisted Spontaneous Breathing** Fixed mandatory minute volume MV set with tidal volume VT and frequency Rate. Between the mandatory ventilation strokes, the patient can breathe spontaneously, thereby contributing to the minute volume. Spontaneous breathing can be supported by ASB. For patients with insufficient spontaneous breathing or for patients who are being weaned by progressive reduction of the mandatory proportion of the total minute volume.

  • Page 78: Bipap,Bipap/Asb

    Apnoea Ventilation-for automatic switch-over to volume-controlled mandatory ventilation if the patient stops breathing. If breathing stops,Crius V6/Crius V8 emits an alarm after the set alarm time (Tapnoea) and starts volume-controlled ventilation with the set ventilation parameters: Rate(Apnoea) and Vt(Apnoea). AutoFlow– for automatic regulation of the inspiration flow.
  • Page 79 The following figure shows typical waveforms in BIPAP and BIPAP/ASB mode. Set the pattern of ventilation for BIPAP and BIPAP/ASB with the ventilation parameters: [Pinsp]:Inspiration pressure [Rate]:Frequency [Tinsp]:Inspiration [O2]:O2 concentration [PEEP]:Positive end-expiratory pressure [Psupp]:Pressure Support [Tslope]:Pressure rise time *The inspiration pressure [Pinsp] can be reduced to the PEEP level,in which case the ventilator pattern corresponds to CPAP or CPAP/ASB.

  • Page 80: Bipap/Assist

    If breathing stops,Crius V6/Crius V8 emits an alarm after the set alarm time (Tapnoea) and starts volume-controlled ventilation with the set ventilation parameters: Rate(Apnoea) and Vt(Apnoea). 6.5.5 BiPAP/assist Biphasic Positive Airway Pressure Assisted pressure-controlled,assisted ventilation The inspiratory strokes are the same as for BIPAP,but the changeover from Pinsp to PEEP is not synchronised with expiration by the patient.

  • Page 81: Cpap,Cpap/Asb

    6.5.6 CPAP,CPAP/ASB Continuous Positive Airway Pressure Assisted Spontaneous Breathing Spontaneous breathing at a raised pressure level in order to increase the functional residual capacity (FRC).Spontaneous breathing can be assisted with additional pressure by ASB. For patients breathing spontaneously. The following figure shows typical waveforms in CPAP and CPAP/ASB mode. Set the pattern of ventilation for CPAP and CPAP/ASB with the following ventilation parameters: [O2]:O2 concentration...

  • Page 82: Mmv,Mmv/Asb

    If breathing stops,Crius V6/Crius V8 emits an alarm after the set alarm time (Tapnoea) and starts volume-controlled ventilation with the set ventilation parameters: Rate(Apnoea) and Vt(Apnoea). 6.5.7 MMV,MMV/ASB Mandatory Minute Volume Ventilation Assisted Spontaneous Breathing The overall minute volume is preset to a mandatory level, which can be adjusted by means of the tidal volume Vt and frequency Rate.

  • Page 83: Aprv

    [Pamx]:Pressure Limited Ventilation MMV and MMV/ASB can be expanded with the following ventilation parameters: Trigger – for synchronisation with attempted spontaneous breathing by the patient. By setting on the flow trigger level,the mandatory strokes are synchronised with the patient’s spontaneous breathing attempts. Spontaneous breathing activity by the patient is indicated by the brief display of a vertical line symbol instead of the usual symbol for the patient mode.Click more menu,to set Trigger parameter.

  • Page 84: Set Alarm Limits

    Apnoea Ventilation-for automatic switch-over to volume-controlled mandatory ventilation if the patient stops breathing. If breathing stops,Crius V6/Crius V8 emits an alarm after the set alarm time (Tapnoea) and starts volume-controlled ventilation with the set ventilation parameters: Rate(Apnoea) and Vt(Apnoea). 6.6 Set Alarm Limits You can set the alarm limits for Paw, PEEP, MVe, Rtotal, VTi, FiO2 and Tapnea by pressing the [Alarm] key and selecting alarm limits in the accessed menu.
  • Page 85 NOTE All the parameter values are calculated based on the real-time flow and pressure waveform data.  For real-time flow and pressure data, low pass filter is adopted at original sampling rate of 1KHz and cutoff frequency of 20Hz. Tidal volume and minute volume displayed on the ventilator are in the BTPS condition. ...
  • Page 86 Disable ATRC Turn on or turn off ATRC function. ET Tube Initiate ATRC function for ET tube. Trach Tube Initiate ATRC function for Trach tube. Tube I.D. It refers to the diameter of tracheal or ET tube. Compliance Turn on or turn off compliance compensate function. compensate Com Exp.Speed It is the expiratory compliance compensate speed.

  • Page 87: Enter Standby Status

    awRR Patients with respiratory rate Inspiratory flow. Expiration flow. P0.1 The occlusion pressure drops in the first 100 ms when the patient starts spontaneous breathing. 6.9 Enter Standby Status Press the [Standby] key. Standby status commences after your confirmation. WARNING To prevent possible patient injury due to lack of ventilatory support, secure alternative ventilation ...

  • Page 88: Chapter 7 Co 2 Monitoring

    Chapter 7 CO Monitoring 7.1 Summary The carbon dioxide monitor is used during respiratory Ventilator therapy, for patient gas monitoring, used in adults, children, babies. CO2 module using the principle of gas having absorption characteristics with infrared to measure the gas concentration.
  • Page 89 measurement value. The two sides windows of airway adapter use the special design and material, can prevent performance degradation due to water vapor. NOTE Main stream IRMA module can only be used by trained or authorized medical staff.  IRMA module can not be used in flammable anesthetic gas environment. ...

  • Page 90: Side Stream

    7.2.2 Side stream ISA side stream CO2 module is through the sampling tube to collect a small quantity of mixed gas from the endotracheal tube of breathing circuit, which is transferred to the sampling gas input port of the monitors, the module will measure and analysis the sample gas. Nomoline sampling tube has a special impermeable area regardless of the direction, the impermeable area with a hydrophobic bacterial filter and made of special polymer.

  • Page 91: Set Co2

    beginning to show red flash, replace the sampling tube. Do not make any changes to the ISA module, if it has been changed, please do appropriate tests  and inspections to ensure long-term safe operation. Do not use ISA module external natural cooling function. ...
  • Page 92 Connect the 15mm female adapter of the airway adapter to the patient’s endotracheal tube; Also, can connect HME (heat and Moisture Exchanger) between the patient’s endotracheal tube and IRMA probe. Can protect the airway adapter from affected by secreta and water vapor through put the HME in front of the probe, so there is no need to replace the adapter.

  • Page 93: Checking Before Using

    AG module defaults to standby mode, when connected AG module, the screen will display【AG is sleeping】. Click 【Menu】 hot key-> 【System Setup】 -> 【CO2 module】 ; 【Operating Mode】 select 【 Measure】 ,the screen display【AG is starting】. After finish the preheat the module into full precision measurement state. NOTE IRMA probe is not designed to be used in contact with the patient;...

  • Page 94: Module Led Status Information

    In the following situations Main stream Anesthetic gas module (IRMA AX+), Main stream CO2 module (IRMA CO2) should be calibrated to zero: Every time after start IRMA probe or change IRMA airway adapter;  Display the gas concentration appear an offset or accuracy error. ...

  • Page 95: Module Cleanliness

    7.3.6 Module cleanliness Allow to clean the probe. Before cleaning should take down the airway adapter, then use the damp cloth that soaked in the highest concentration of 70% of medical alcohol to clean the probe, at last, with a dry lint-free cloth to dry it.

  • Page 96: Checking Before Using

    starting】. 7.4.2 Checking before using Before connecting Nomoline sampling tube to the mask of the patient, please do the following checking: Ensure that the you have finished all related operations in Chapter "7.4.1 Installation"; Exhale to the sampling tube to check if the monitoring interface of the ventilator has display valid waveform and value;...

  • Page 97: Module Calibration

    (mmHg)=CO concentration × pressure from the ISA (kPa) × (750/100). For example: 5.0Vol%Co2(101.3kPa)，according to the above method transfer: 0.05×101.3×750/100=38 mmHg. Effects of moisture The partial pressure and the volume percentage of CO2, Nitrous oxide, O2 and Anesthetic depend on water vapor content. Calibrate theO2 measurement will display 20.8Vol% at the actual ambient temperature and humidity level, but not the actual partial pressure.

  • Page 98: Module Led Status Information

    monitor calibration time less than 10s. NOTE Exist air in the ISA module is very important for zero calibrating successfully, so need  to ensure its ventilated environment is good; before and after zero calibration, avoid breathing in its vicinity. ISA modules adopt stable design, and has been done a permanent calibration when ...

  • Page 99: About Masimo

    If this Ventilator need to configure mainstream CO module(IRMA CO )，or sidestream CO module(ISA )，need to do O2 compensation set to ensure the accuracy of CO monitoring. Operation see "5.14.3 Compen ". NOTE If equipped IRMA CO or ISA CO module, in the monitored gas exist nitrous oxide or ...

  • Page 100: Chapter 9 Special Functions

    Chapter 9 Special Functions 9.1 Manual Breath Select the [Tools] key→[Functions]→[Manual Breath], and the ventilator system delivers a breath to the patient based on the current ventilation mode. NOTE Manual breath is disabled in Standby status.  Pressing the [Manual Breath] key during inspiratory phase cannot initiate a manual ...

  • Page 101: 100%O2 (O2 Enrichment)

    Inspiration Hold function. Inspiration Hold is active for a maximum of 30 seconds. If the [Insp. Hold] key is pushed and held for more than 30 seconds, the ventilator terminates the Inspiration Hold function automatically. NOTE Inspiration Hold function is disabled in CPAP mode and is supported when apnea ...

  • Page 102: O 2 Therapy

    Select [P0.1] to access the P0.1 measurement window. Select [Start]. The system starts P0.1 measurement and prompts [Measurement Active]. After the measurement is completed, the measurement result is displayed. The ventilator can display the three most recent measurement results. After the measurement is completed, Waveforms and Spirometry screen is frozen automatically. NOTE During P0.1 measurement, pressing the [Freeze] key does not produce freezing ...

  • Page 103: O2 Therapy Timer

    Select [O Therapy] in the Standby status to enter O therapy screen. Set [Flow], [O %] and [Pmax] to appropriate values as required. 9.7.2 O2 Therapy Timer Select the O Therapy Timer area in the top left corner to access the window as shown below. Select [Stop]/ [Start] to stop or start timing.
  • Page 104 During O therapy, select the [Standby] key to enter Standby status after confirmation, so as to switch off the O therapy function. 104 / 182...

  • Page 105: Chapter 10 Alarms

    Chapter 10 Alarms 10.1 Summary 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 106: Alarm Level

    10.1.2 Alarm level According to the severity of the alarm, the physiological alarm of the ventilator can be divided into advanced alarm, secondary alarm and low-level alarm.  High Priority alarm The patient is in critical condition, and may have life risk, should be an immediate rescue. ...

  • Page 107: Audible Alarm

     Low Priority alarm: Yellow, normally on not twinkle 10.2.2Audible alarm Audible alarm refers to when the alarm occurs, ventilator adopts different voice characteristics to indicate different levels of the alarm. High priority alarm: the speaker gives out rhythmic sound prompt, i.e. The ...

  • Page 108: Parameters Scintillation

    Secondary alarm: !!  Low-level alarm: !  10.2.4Parameters scintillation When the alarm of parameters which are for monitoring the patients such as monitoring EtCO2, FiCO2, awRR, the parameter value will blink once per second frequency, high limit or lower limit of the parameter will also be the same frequency flashing, indicating that the parameter exceeds the upper limit or a low limit.

  • Page 109: Set Alarm Limits

    10.5 Set Alarm Limits CAUTION In case that high pressure alarm limit of 60 cmH2O is not required under clinical condition, setting  high pressure alarm limit to 60 cmH2O or less is recommended so as to extend the service life of the turbine and the battery.

  • Page 110: Paw Too Low

    Verify that the [Paw Too High] alarm is activated, the ventilator cycles into expiration, and airway pressure falls to PEEP level. 10.6.3 Paw Too Low After the ventilator system starts up normally, connect a test lung to the ventilator and start ventilation.

  • Page 111: Peep Too Low

    10.6.9PEEP Too Low After the ventilator system starts up normally, connect a test lung to the ventilator and start ventilation. Set the PEEP low alarm limit to be greater than the current PEEP. Verify that the [PEEP Too Low] alarm is activated. 10.6.10 Rtotal Too High After the ventilator system starts up normally, connect a test lung to the ventilator and start...

  • Page 112: Etco2 Too High

    10.6.14 EtCO2 Too High Connect a test lung to the ventilator and start ventilation. Module] to set Connect the CO test module. Select the [Menu] key → [System setup] → [CO [Operating Mode] to [Measure]. After CO warm-up is completed and the CO module enters operating mode, deliver 3 % to 7 % of standard gas to the sampling port of sidestream CO module or the airway adapter of...

  • Page 113: Awrr Too Low

    Set the awRR high alarm limit to be less than the current awRR. Verify that the [awRR Too High] alarm is activated. 10.6.18 awRR Too Low Connect a test lung to the ventilator and start ventilation. Connect the CO2 test module. Select the [Menu] key → [System setup] → [CO2 Module] to set [Operating Mode] to [Measure].

  • Page 114: Alarm Information Table

    CAUTION Contact the Customer Service Department if the alarm persists without obvious cause.  10.8 Alarm information table 1) Alarm information includes physical and technical alarm information, but some alarm information is not necessarily listed. 2) Column P stands for the default alarm level: H for high, M for medium and L for low. 3) For each alarm message, list all the corresponding countermeasures.
  • Page 115 Alarm message Level Cause and action Too Low 4. Calibrate the O2 sensor. The TVe monitored value is greater than TVe high alarm limit for continuous 3 mechanical ventilation cycles. 1. Check the ventilation parameter setup. Vti Too High 2. Check the alarm limits. 1.

  • Page 116: Technical Alarm

    Alarm message Level Cause and action 1. Check the patient. Rtotal Too Low 2. Check the ventilation parameter setup. Apnea Ventilation This alarm is given when apnea ventilation ends. There is no need to process this alarm. The monitored parameter value exceeds the alarm limit. 1.
  • Page 117 Alarm message Leve Cause and action power supply, battery-powered. If AC disconnect, alarm limit for at least 13s. AC Disconnect The device is not connected to an external power supply Please access the external power supply. Breathing communication failure. MERCURY Comm. Please check if the ventilator communication USB interface Malfunction cable is loose.
  • Page 118 Alarm message Leve Cause and action 1. Check the ventilation parameter setup. 2. Check the O supply. % Too Low 3. Calibrate the O sensor. Monitored PEEP exceeds PEEP+5 cmH O within any fully mechanical ventilation cycle. 1. Check the ventilation parameter setup. PEEP Too High 2.
  • Page 119 Alarm message Leve Cause and action stopped 1. Check if the module is faulty. 2. While removing the ventilation module, unplug the CO2 module. 3. Please contact your designated service representative. Parameter measured values exceed the measurement range (error range is included). EtCO Over range Perform CO2 module zeroing.

  • Page 120: Chapter 11 Cleaning And Disinfection

    Chapter 11 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 O2 sensor can leak and cause burns (contains ...

  • Page 121: Methods For Cleaning And Disinfection

    Do not use organic, halogenated, or petroleum based solvents, anesthetic agents, glass cleaners,  acetone, or other harsh cleaning agents. Do not use abrasive cleaning agents (such as steel wool, silver polish, or cleaner).  Keep all liquids away from electronic parts. ...
  • Page 122 Ventilator external surface (including Each patient housing, power cord, supply ① gas hose) Trolley and support arm Each patient ① Touch screen Each patient ① Fan dust filter Every four weeks/as ② necessary* Main unit air outlet dust filter Every four weeks/as ②...

  • Page 123: Cleaning,Disinfection

    A: Wipe: wipe with a damp cloth immersed in medium- or high-efficiency detergent and then wipe off the remaining detergent with a dry lint free cloth. Immersion: immerse it in medium-efficiency or high-efficiency detergent (alcohol or isopropyl alcohol, etc.) for more than 30 minutes (recommended time). Then clean with water and dry completely.
  • Page 124 A. Expiration valve assembly B. Expiration valve handwheel C. Expiration valve membrane To disassemble the expiration valve assembly:  According to the position rotate the expiration valve handwheel counter-clockwise until unlock. Then pull out the expiration valve assembly horizontally. Remove the expiration valve membrane. Disinfection methods:refer to 11.1 Methods for Cleaning and Disinfection.

  • Page 125: Inspiration Safety Valve Assembly

    11.2.2 Inspiration Safety Valve Assembly 11.2.2.1. Inspiration Safety Valve Assembly A. Sealing ring B. Safety valve assembly C. Safety valve handwheel To disassemble the inspiration safety valve assembly:  Ensure ventilator is in Standby or switched off. According to the position rotate the expiration valve handwheel counter-clockwise until unlock.
  • Page 126 to the end. According to direction of rotation, then rotate the expiration valve handwheel clockwise (and depress the handwheel in the direction the expiration valve is installed) until the knob to tight. 11.2.2.2. Inspiration Safety Valve Membrane Safety valve body B. Membrane fixing knob Safety valve membrane D.

  • Page 127: High Efficiency Particle Air (Hepa) Filter Assembly And Dust Filter

    membrane support can be seen through the hole on the membrane fixing knob. Align the guides on membrane fixing knob with the grooves of safety valve body. Insert the membrane fixing knob, press it tightly and rotate it clockwise to the end position. 11.2.3 High Efficiency Particle Air (HEPA) Filter Assembly and Dust Filter A.

  • Page 128: Patient Tubing

    Install the main unit air inlet grille. NOTE Install the specified HEPA filter and air intake dust filter.  The HEPA filter is used repeatedly,however, it needs to be cleaned or disinfected, cleaned or  disinfected method chapter 11.1, and replaced if damaged. CAUTION Do not run the ventilator if the ventilator is not equipped with HEPA filter to avoid contaminating ...
  • Page 129 A. Inspiratory filter B. Expiratory filter C. Inspiratory filter D. Expiratory filter E. Heat & Moisture Exchange (HME) To disassemble the patient tubing: Pull out the patient tubing one by one.  Disinfection methods: The patient tubing is single-use, can not be cleaned and disinfected to reuse ...

  • Page 130: Humidifier

    11.2.5 Humidifier NOTE The humidifier shall comply with the requirements of ISO 8185. The humidifier assembly, its  installation and disassembling steps described in this section are only for reference. 11.2.5.1 Humidifier on the Ventilator A. Humidifier Humidifier mounting plate C.

  • Page 131: Mainstream Co2 Sensor

    Lift up the humidifier to remove it from the humidifier bracket fixed seat. Disinfection methods: refer to the method in user manual recommended by the manufacturer of  humidifier for Cleaning and Disinfection. To install the humidifier onto the ventilator: ...

  • Page 132: Chapter 12 Maintenance

    Chapter 12 Maintenance 12.1 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. Take care to  move or replace system parts and components. Do not use lubricants that contain oil or grease.
  • Page 133 As necessary Inspiration safety valve When the patient’s exhaled gas may contaminate the assembly inspiration safety valve assembly, it is necessary to replace with disinfected inspiration safety valve and membrane (refer to 11.2.2). Expiration valve Replace the expiration valve if it is damaged (refer to 11.2.1).

  • Page 134: Essential Performance

    Air intake HEPA filter Replace (refer to 11.2.3). Ventilator Contact us for preventive maintenance. Check valve Check the check valves, including gas source check valve, spontaneously inspiratory check valve, and expiratory limb check valve. Contact us for replacement if necessary. Backup alarm system Check the alarm duration of backup alarm system (buzzer).

  • Page 135: Pressure And Flow Zeroing

    201.101 TABLE: ESSENTIAL PERFORMANCE Recommended frequency to List of reference clause from ESSENTIAL check the Validation Method functions standard(s) of ISO 80601-2-12 PERFORMANCE essential performance CONDITIONS year or when in the manual 201.12.4.101 doubt. AIRWAY PRESSURE The clause of ISO 80601-2-12: once per See Chapter 10.6 of the year or when in...

  • Page 136: Flow Calibration

    12.5 Flow Calibration NOTE Do not perform calibration while the unit is connected to a patient.  Do not perform flow calibration when low-pressure oxygen source is used.  During calibration, do not operate the pneumatic parts. Especially, do not move or press the ...

  • Page 137: Co Calibration

    from the setting, or when the O sensor is replaced. Follow these steps to calibrate the oxygen concentration: Ensure high-pressure oxygen source is connected. In standby state. Select [Calibrate] ->[O Cal.]. Select [Start] on the right side to start Flow Calibration.

  • Page 138: Touch Screen Calibration

    After a successful calibration, the screen shows [CO % Calibration Completed!]. Otherwise, the message [Calibration Failure! Try again!] is displayed. In this case, you need to do the calibration again. 12.7.2 Mainstream CO Module For a mainstream CO module, manual calibration is not required. The system sends altitude to the mainstream CO module for calibration compensation.

  • Page 139: Battery Performance Conditioning

    replacing lithium batteries every 2 years. In case of battery failure, contact us or have your service personnel replace it. Do not replace the  battery without permission. Check battery performance once every six months. Checking battery performance is also required ...

  • Page 140: Battery Performance Checking

    battery, the battery full icon does not indicate that the battery capacity or battery running time still meets the requirement specified. When conditioning batteries, replace the battery when its running time becomes noticeably short. Follow these steps to condition batteries: Disconnect the patient from the ventilator and shut down the ventilator.

  • Page 141: Battery Storage

    12.9.3 Battery Storage During storing batteries, ensure the battery electrodes do not get in touch with metal. In case of long-time storage, place batteries in a cool environment and keep battery power at 40% to 60%. Placing batteries in a cool environment can delay battery aging. Ideally, batteries should be stored in a cool environment of 15℃...

  • Page 142: Electrical Safety Inspection

    Before disposing of your Ventilator (Model: Crius V6,Crius V8), please take away the batteries from Ventilator (Model: Crius V6,Crius V8) and dispose of the batteries and Ventilator (Model: Crius V6,Crius V8) separately.

  • Page 143: Water Build-Up In The Flow Sensor

    NOTE Perform electrical safety inspection after servicing or routine maintenance. Before the electrical  safety inspection, ensure all the covers, panels, and screws are correctly installed. The electrical safety inspection should be performed once a year.  Perform protective earth resistance test: Plug the probes of the analyzer into the protective earth terminal of the AC power cord and the screw.

  • Page 144: Clear Water Build-Up

    volume fluctuation is detected. If there is water build-up inside the expiration valve, clear it before use. Check the expiratory water trap for water during the use of the ventilator. If there is water build-up, empty it promptly. Water condensation in the expiration valve can be reduced by using a bacteria filter between the expiratory tube and expiration valve.

  • Page 145: Chapter 13 Accessories

    Chapter 13 Accessories WARNING The user shall buy legally launched products for other accessories required to implement the  functions of the machine. Do not use in the event of damage to the sterile packaging.  Use only accessories specified in this chapter. Using other accessories may cause incorrect ...

  • Page 146: Recommended Device Combined With Ventilator To Use

    O2 Gas Supply Hose 082.01.000180-00 Oxygen Sensor 040.01.000029-00 Humidifier 40.01.000539-00 * :The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians, for example, clinicians performing photodynamic therapy. Recommended device combined with ventilator to use During ventilation process the following device can be combination with the ventilator to use.

  • Page 147: Chapter 14 Theory Of Operation

    Chapter 14 Theory of Operation 14.1 Pneumatic System 14.1.1 Pneumatic Circuit Diagram 14.1.2 Parts List Symbol Description Symbol Description Low-Pressure Air supply (low pressure) PZTV1 Zeroing three-way valve Inlet Dust filter (Air) Inspiratory pressure sensor Inspiratory pressure sensor filter HEPA filter (Air) Vacuum sensor (Air) Humidifier Humidifier...

  • Page 148: Theory

    High-Pressure supply (high pressure) Inlet Filter (O Regulator PSOL Proportional Water trap solenoid valve Bacteria filter (connecting to Filter screen inspiratory port) Flow sensor Expiratory flow sensor Level 1 Bacteria filter (connecting to mixed noise patient port) reduction chambe Temperature sensor Filter Blower Turbine blower...
  • Page 149 specific O concentration is formed in the upstream of inspiration valve after Air and O are mixed. Such gas becomes gas with specific flow or pressure after passing through the inspiration valve and enters the patient’s lungs via inspiratory tube. During the expiratory phase, the inspiration valve is closed while the expiration valve opens.
  • Page 150 Check valve (CV3) prevents patient’s expired gas from polluting the components in the upstream of this valve under the single fault condition of expiratory limb being occluded. Safety valve (SAV) ensures that the pressure in the inspiratory limb is kept within the safe range and provides flow to the spontaneous inspiratory channel when the system is powered down.

  • Page 151: Chapter 15 Product Specifications

    Chapter 15 Product Specifications The ventilator is already integrated with expiratory volume monitor, pressure measurement device, and pressure release device. It is equipped with alarm system, O monitor and CO monitor, where: The expiratory volume monitor, pressure measurement device, and pressure release device comply ...

  • Page 152: Power Requirements

    Degree of BF, defibrillation-proof protection against electric shock Operating mode Continuous Degree of Ordinary equipment, without protection against explosion; not for protection against hazards use with flammable anaesthetics. of explosion Degrees of protection provided by enclosures (IP Code)—IP21 Protection Index according the EN 60529 standard: Degree of 2: Protected against solid foreign objects of 12.5 mm diameter protection against harmful...

  • Page 153: Physical Specifications

    Approximately 27.5kg (including the ventilator cart) Approximately 12.5kg (excluding the ventilator cart) Caster Caster 4 casters. All casters have brakes. Display Type TFT LCD Crius V6：15.6" Size Crius V8：12.1" Resolution Crius V6：1366 x 768 pixels Crius V8：1280 x 800 pixels Brightness Adjustable 153 / 182...

  • Page 154: Pneumatic System Specifications

    Touch screen Available, anti-glare. LED indicator One (yellow and red. When high and medium priority alarms occur Alarm LED simultaneously, it flashes red only). External power LED One (green; lit when the external power supply is connected). One (green; lit when batteries are installed and external power supply is Battery LED connected;...
  • Page 155 Connector NIST or DISS Fresh gas Fresh gas is called after supplied Air and O are mixed. Low-pressure oxygen inlet Pressure range Less than 100 kPa Maximum flow 15 L/min (STPD) Connector CPC quick connector Inspiration module ≥210 L/min (BTPS) Peak flow in case of single Safety valve release pressure <125 cmH Coaxial 22 mm/15 mm conical connector...

  • Page 156: Ventilator Specifications

    Not greater than 6 cmH O at 60 L/min flow (adult reusable patient tubing) Not greater than 6 cmH O at 30 L/min flow (pediatric reusable Expiratory resistance patient tubing) Not greater than 6 cmH O at 5 L/min flow (infant reusable patient tubing) Resistance: <...
  • Page 157 ±5% of set value,or ±2Vol.%.whichever is concentration greater. (VT=500ml, maximum value for attachment combination in accordance with ISO 80601-2-12) : ≤50s; 21 to 100 Vol.% 1Vol.% (VT=150ml, maximum value of attachment combination in accordance with ISO 80601-2-12) : ≤80s; (VT=30ml, maximum value of attachment combination in accordance with ISO 80601-2-12) : ≤125s.) PEEP...
  • Page 158 ±5% of set value,or ±2Vol.%.whichever is 21～100Vol% 1Vol% greater. concentration Performance Date Control Time-cycled,volume-constant,pressure-controlled principle Intermittent PEEP 2 cycles every 3 minutes frequency disconnectio automatic n detection Reconnectio automatic n detection oxygen max. 3 minutes enrichment active suction max. 2 minutes phase final oxygen 2 minutes...

  • Page 159: Settable Alarms

    0 to 3999mL(BTPS) ±8% of measured value VTspon 0 to 3999mL(BTPS) ±8% of measured value VTASB 0 to 3999mL(BTPS) ±8% of measured value Rtotal 0 to 150/min 1/min ±1/min RRspon 0 to 150/min 1/min ±1/min Serial dead space ±10% measured value or 0 to 999mL(BTPS) 0.1mL ±10mL,whichever is greater...

  • Page 160: Special Functions

    length High limit 0.1 L/min 0.1 to 41 L/min Low limit 0.1 L/min 0.01 to 40 L/min if the value "PEEP +5 10 to 100cmH 1cmH High limit cmH2O" (coupled with Low limit Airway the PEEP set value) is pressure not exceeded for at least No lower alarm limit 96 ms in 2 successive...

  • Page 161: Module Specifications

    Inspiration Hold Push and hold the Insp. Hold key to activate this function. Inspiration Hold is active for a maximum of 30s. Expiration Hold Push and hold the Exp. Hold key to activate this function. Expiration Hold is active for a maximum of 30s. 100%O 100%O is delivered for a fixed 2 min.
  • Page 162 Sidestream: no need to operate calibration. Automatically zero when starts. Calibration Mainstream : no need to operate calibration, to zeroing when replace the airway adapter. Scope Aaccuracy Resolution Measurement scope ±(0.43Vol%+8% of the 0.1Vol% 0～ and accuracy reading) 13Vol% (standard conditions) The above accuracy is applied for the dry gas in 22℃±5℃，1013±40hPa Accuracy...
  • Page 163 Sevoflurane, Enflurane Desflurance 15vol% +12% of the reading3) 50vol% -6% of the reading3) 80vol% -10% of the reading3) Quantitive spray Not applied6) Ethyl Alcohol 0.3vol% Isopropanol 0.5vol% Acetone 1vol% Methane 3vol% 0.02vol% 1vol% 100vol% -1&2) Note 1: in the above “measurement range and accuracy (all conditions)” including the negligible interference and influence.
  • Page 164 General specifications Description Compact, low-flow sidestream gas analyzers with integrated pump and flow controller. Dimensions 91 mm x 60 mm x 37 mm (3.6 x 2.4 x 1.4) Mechanical interface 4 threaded holes for M2 bolts Pneumatic interface NomoLine gas inlet Evac connector intended for 1.6.
  • Page 165 Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature) Operating atmospheric 525 to 1200 hPa (52.5 kPa to 120 kPa) pressure (corresponding to a max altitude of 5211 m / 17100 feet) Storage/transport atmospheric 200 to 1200 hPa (20 kPa to 120 kPa) pressure (corresponding to a max altitude of 11760 m / 38 600 feet) Ambient CO...
  • Page 166 No breaths detected Check sampling line Unspecified accuracy Sensor error Volumetric flow rate of air corrected to standardized conditions of temperature and pressure. Flow accuracy specification for the extended temperature range (-20 to 0°C) is +15/-10 sml/min. llow the unit to sample air for at least 20 minutes if an alarm message is displayed after exposure to water. Measured at I/E ratio 1:1 using breath simulator according to EN ISO 80601-2-55 fig.
  • Page 167 Effects from water vapor partial pressure on gas readings When the breathing gas flows through the sampling line, the gas temperature will adapt to the ambient temperature before reaching the gas analyzer. The CO measurement will always show the actual partial pressure at the current humidity level in the gas sample. As the NomoLine sampling line removes all condensed water, no water will reach NomoLine ISA CO system However at an ambient temperature of 37 °C and a breathing gas with a relative humidity of 95%...
  • Page 168 In addition to the EN ISO 80601-2-55:2018 standard. Mainstream CO2 module: General specifications Description Extremely compact infrared mainstream multi-gas probe available in two parameter configurations Dimensions 38 mm x 37 mm x 34 mm (1.49 x 1.45 x 1.34) Cable length 2.5m±0.1m Weight <25g (cable exclude)
  • Page 169 Water ingress protection The NomoLine gas inlet provide a watertight seal making it possible to use NomoLine ISA Capno built-in module in IPX5 rated instruments Particulate and water ingress The NomoLine ISA CO Sidestream Gas Analyzer is IP34 rated. protection Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature) Operating atmospheric...
  • Page 170 with a weight function applied to favor values closer to the end of the cycle. EtCO2 will typically decrease below nominal value (ETnom ) when respiration rate (RR) exceeds the RR threshold (RRth) according to the following formula: Diagnostic parameters Atmospheric pressure, Cuvette pressure Serial number Software revision Hardware revision Flags...
  • Page 171 Alarm upper and lower limit setting Range Resolution FiCO2 alarm upper limit 0 to 100 mmHg, or 0.1 to 15kPa 1mmHg,or 0.1kPa EtCO2 alarm lower limit 0 to 99 mmHg,or 0 to 14.9 kPa 1mmHg,or 0.1kPa EtCO2 alarm upper limit 0 to 100 mmHg, or 0.1 to 15kPa 1mmHg,or 0.1kPa ( lower limit+1)～120bpm...

  • Page 172: O2 Sensor Specifications

    “Accuracy, all conditions” above. Negligible interference, effect included in the specification “Accuracy, all conditions” above. Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO and 50 vol% Helium, the actual measured CO concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO...

  • Page 173: Factory Defaults

    For optimum performance at elevated oxygen levels calibrate with 100% oxygen. From the signal output value established above, and, once the sensor reaches equilibrium (approximately 1 hour) following step change of 15°C or more. For optimum performance, mount sensor with sensing surface pointing down or horizontal Sensors may be stored at -10 to 60ºC on an intermittent basis only up to one week, such as during transportation.

  • Page 174: User Setting

    awRR high [/min] Rtotal [/min] ---- Tapnea [s] ---- 5.11.3 User setting Setting Factory default setting Layout Normal Setting Pattern Paw unit Pressure unit Wave mode Fill Time-date format YYYY-MM-DD Time-time format 24 h Alarm delay Alarm Vol BackLight 15.11.4 History Data Trend log Factory default setting Graphic trend-interval...
  • Page 175 Crius V6/Crius V8 ventilator is in compliance with IEC 60601-1-2 for EMC. The essential performance verified during the immunity testing comprise of TVi control accuracy, TVi monitoring accuracy, CO monitoring accuracy, O control accuracy, O monitoring accuracy, PEEP control accuracy and PEEP monitoring accuracy.
  • Page 176 /Crius V8 The Crius V6 ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the Crius V6 ventilator should assure that it is used in such an environment. IMMUNITY test IEC 60601...
  • Page 177 The Crius V6 ventilator is intended for use in the electromagnetic environment specified /Crius V8 below. The customer or the user of the Crius V6 ventilator should assure that it is used in such an environment as described below. IMMUNITY test IEC60601TES...
  • Page 178 3V/m 3 Vrms Radiated RF 80 MHz～2.5 IEC61000-4-3 (for RGM, SpO performance) 10 V/m Where, is the maximum output power 10 V/m 80 MHz～2.5 rating of the transmitter in watts (W) GHz (for according to the transmitter manufacturer and Ventilator is the recommended separation distance in meters (m).
  • Page 179 /Crius V8 radiated RF disturbance are controlled. The customer or the user of the Crius V6 ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable...
  • Page 180 180 / 182...

  • Page 181: Appendix A Toxic Or Harmful Substances Or Elements

    Appendix A Toxic or Harmful Substances or Elements Cr(VI) PBDE Part name  ○ ○ ○ ○ ○ ○ Ventilator casing ○ ○ ○ ○ ○ ○ Machine ○ ○ ○ ○ ○ ○ casing facing ○ ○ ○ ○ ○...
  • Page 182 Northern Meditec Limited Address: Room 501, 502 Building A, Room 401 Building C, JinWeiYuan Industrial Area, No.41 Qingsong Road, Zhukeng Community, Longtian Sub-district, Pingshan District, 518118 Shenzhen City, P.R. China Post Code: 518118 Tel.: + 86 755 27952733 Fax.: +86 755 86528647 E-mail: info@northernmeditec.com...

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