Northern Meditec Crius V5A Operator's Manual

Neonatal ventilator

Quick Links

Download this manual

Neonatal Ventilator

Crius V5A,Crius V5B

manual

Operator's

Northern Meditec Limited

Table of Contents

Need help?

Do you have a question about the Crius V5A and is the answer not in the manual?

Questions and answers

Summary of Contents for Northern Meditec Crius V5A

Page 1 Neonatal Ventilator Crius V5A,Crius V5B manual Operator’s Northern Meditec Limited...
Page 2: Product Information
Copyright Operator’s Manual Document No./Version: NR-TU-0916-102/1.5 For this Operator’s Manual, the issue date is March,2025. © 2015-2017 ShenZhen Northern Meditec Limited. All rights Reserved. Product Information Product Name: Neonatal Ventilator Models: Crius V5A,Crius V5B Software Version: V01 CE information： 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,...
Page 3 Statement The user manual and the corresponding products of intellectual property belongs to 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: Warranty
Warranty Northern Meditec Limited will be responsibility of the safety,reliability and performance of its products on the conditions that the following conditions are complied: The products are operated as per the User’s Manual;  The products are installed, maintained and upgraded by personnel approved or authorized by ...
Page 5: Customer Service Department
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 6: Intended Use
Preface This Manual provides the performance, operating instructions, safety instructions and other information about our Crius V5A or Crius V5B Neonatal Ventilator It is a start guide for new users. Intended use The Neonatal Ventilator is intended to provide noninvasive respiratory support for infants born at 27~37 weeks of gestational age (GA), with a birthweight (BW) of 600g~1500g, affected by respiratory distress syndrome (RDS).
Page 7: Product Life
Figures All figures contained herein are for reference only. The menu items, settings and parameters in the figures may be somewhat different from that in the ventilator you've received. Definitions  —>： Connect the operating steps. Characters Indicate the character string in the software. 【...
Page 8: Table Of Contents
Table of Contents Chapter1 User’s Responsibilities ..................12 1.1 Instruction .............................12 1.2 Intended Use ..........................12 1.3 Operating staff ..........................15 1.4 Environmental Requirements .......................16 1.5 Safety Instructions ........................17 1.5.1 Safety information ......................17 1.5.2 Warning ..........................18 1.5.3 Caution ..........................21 1.5.4 Attention ..........................
Page 9 3.10.1 Enter the freeze state ..................... 46 3.10.2 Exit the freeze state ......................47 3.11 Lock screen function ........................ 47 3.12 Screenshot ..........................47 3.13 Neonatal ventilator parameter settings ................... 48 3.13.1 Set the Oxygen Concentration ..................49 3.13.2 Set the CPAP ........................49 3.13.3 Set the Apnea time ......................
Page 10 5.2.4 Connecting the Abdominal Respiratory Sensor ..............72 5.2.5 Install Pressure Generator and Nasal Cannula （or Nasal Mask） ......73 Chapter6 Alarm ........................77 6.1 Overview ............................ 77 6.1.1 Alarm Type ......................... 77 6.1.2 Alarm Level ........................78 6.2 Alarm Indication ...........................78 6.2.1 Alarm Indicator ........................79 6.2.2 Alarm Sounds ........................
Page 11 12.1.2 Components ........................99 12.2 Electrical System Diagram ....................... 100 12.2.1 Electrical System Diagram .....................100 12.2.2 Components ......................... 100 12.3 Classification under IEC60601-1 and Applicable Standards ..........101 12.4 Power supply .......................... 101 12.4.1 Power specifications ....................... 101 12.4.2 Power cord ........................102 12.5 EMC and Radio Regulatory Compliance ................103 12.6 Physical Specifications ......................
Page 12: Chapter1 User's Responsibilities
Chapter1 User’s Responsibilities 1.1 Instruction The System should be installed, operated, maintained and repaired in accordance with this Manual. Regular inspections are required for the ventilator. If the ventilator has any fault or failure, or damaged, missing, worn, deformed or soiled component, please contact our customer service department or agent in your area immediately for repair or replacement.
Page 13 CPAP or (s)NIPPV should be started from birth in all babies at risk of RDS, such as those <30  weeks of gestation who do not need intubation for stabilisation. The system delivering CPAP is of little importance; However,the interface should be short binasal ...
Page 14: Side Effects
Indications/Medical condition Respiratory distress syndrome (RDS) Contraindications Cardiopulmonary arrest  Hemodynamic instability  Glasgow coma scale score under 10  Facial deformity  Facial trauma or surgery  Undrained pneumothorax  Endotracheal intubation to manage secretions or airway protection  Upper gastrointestinal tract active bleeding ...
Page 15: Operating Staff
Duration of contact 28 days. Notice in case of serious incident The user is obligated to report all serious incidents which occur in connection with the product to the manufacturer as well as the competent authority of the member state/country in which the user is located. Serious incidents are defined as malfunctions, breakdowns or changes in the characteristics or the performance or inadequacies in the labeling or instructions for use of a medical device which directly or indirectly lead to, could have led to or could lead to the death or a serious worsening in the state of health...
Page 16: User Profile
User profile: Person Group and Occupation Qualified clinician Adult (above25 years old) Knowledge minimum: - Read and understand text and Arabic numerals; - Read this manual. - Have professional medical knowledge. - Have professional knowledge of respiratory system. Linguistic English or local official language Education - At least 18 years old and 12 years intensive reading experience(school).
Page 17: Safety Instructions
2. Power Supply AC：100-240V～ 50/60Hz； Built-in rechargeable battery：14.8V 5200mAh； 3. Gas supply: dry and clean compressed medical gas (pressure:0.28～0.6MPa). 4. Transport and Storage Condition Ambient temperature：-20℃～55℃（Oxygen battery：-20℃～50℃）； Relative humidity:0%～95%，non-condensing； Atmospheric pressure：50.0kPa～106.0kPa. 1.5 Safety Instructions Safety information 1.5.1 Warning Indicates potential serious consequences, adverse events or unsafe situations. Failure to follow ...
Page 18: Warning
Warning 1.5.2 Warning The ventilator must only be operated and used by authorized medical personnel well trained  in the use of this product. It must be operated strictly following the Operator’s Manual. The part of the product that comes into contact with the patient does not contain natural latex ...
Page 19 When handling packaging materials, you must comply with the relevant local regulations, or  the hospital waste disposal system. Packaging materials must be kept out of the reach of children and out of harm to the surrounding environment. Maintenance menu can only be accessed when the equipment is disconnected from the patient. ...
Page 20 When the ventilator’s gas supply input system fails or has faults, please contact us  immediately for service by specified personnel. The ventilator shall not be used with helium or mixtures with Helium.  Do not move the ventilator before removing the support arm from it, in order to avoid the ...
Page 21: Caution
It is the responsibility of the responsible organization to ensure that the oxygen source is  compatible with the rated range of pressure, flowrate and oxygen concentration as marked on the ventilator and indicated in the instructions for use as this can affect the performance of the ventilator that can consequently result in patient death or serious deterioration of health.
Page 22 MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. This system operates correctly at the electrical interference levels identified in this manual.  Higher levels can cause nuisance alarms that may stop mechanical ventilation. Pay attention to false alarms caused by high-intensity electrical fields.
Page 23: Attention
Peak pressures, exceeding 33 cmH2O, may increase the risk of aspiration due to gastric  insufflation. When ventilating with such pressures, consider using an invasive mode. To reduce the risk of fire, use only tube systems approved for medical purposes and for use ...
Page 24: Network Security Description
Ventilator alarm parameters will not trigger alarms within alarm limits. Ensure that the  current alarm preset of the device is appropriate before it is used on each patient. Air source interruption below 0.2Mpa will alarm  This manual describes the product according to the most complete configuration. The product ...
Page 25 upgrades. The USB flash drive file must match the software to read the USB flash drive. 25 / 115...
Page 26: Chapter2 Product Overview
Chapter2 Product Overview 2.1 Appearance Fig 2-1 Neonatal Ventilator(Blue) 26 / 115...
Page 27: Symbols
Fig 2-2 Neonatal Ventilator(Pink) 2.2 Symbols Explanation symbol Be careful! Please read the User Manual first. Abdominal respiration sensor interface Defibrillation-proof type BF applied part Pressure sampling port Fresh gas outlet AC/DC power indicator Battery indicator Mute 27 / 115...
Page 28 Explanation symbol Standby System powered on/off Air inlet Equipotential grounding rod USB port Serial port Network Oxygen inlet  Information about the AC power port Information about the DC power port VDC 12-24V Battery Oxygen battery Fuse Menu key Nurse call interface Instruction icon “Follow the instructions for use”...
Page 29 Explanation symbol Fragile, handle with care Stacking limit by number Keep dry Indicates the item is a medical device CE mark The device should be sent to the special agencies according to local regulations for separate collection after its useful life Degree of protection provided by enclosure IP21 Recyclable...
Page 30: Abbreviations
Explanation symbol Indicates the model number or type number of a product 2.3 Abbreviations Abbreviations explanation CPAP Continuous positive airway pressure Flow Fresh gas flow Nasal continuous positive airway pressure NCPAP Nasal intermittent positive pressure ventilation NIPPV Oxygen concentration FiO2 Inspiratory O2 concentration Ppeak Peak airway pressure...
Page 31: System Composition
2.4 System composition Front 2.4.1 Fig 2-3 Front of Neonatal Ventilator Name Name Respiration Circuit arm Caster Display screen Fresh gas outlet Abdominal respiration sensor port Pressure sampling port Humidifier Storage frame Water bag support Trolley Reserved port 31 / 115...
Page 32: Back
Attention The maximum bearing capacity of this support arm does not exceed 1kg.  The maximum bearing capacity of this water bag support does not exceed 1kg.  The maximum bearing capacity of this humidifier bracket fixing seat does not exceed 3kg. ...
Page 33: Components
Notes RJ45 network port---Used for manufacturer program upgrade.  Calibration serial-port---For manufacturer calibration.  USB port---Used for manufacturer program upgrade.  2.5 Components Control Components 2.5.1 2.5.1.1 Optional function of ventilation mode The System provides the following ventilation modes: NCPAP modes ...
Page 34 Fig 2-5 Control Panel of Neonatal Ventilator Name Name Pressure Generator Type Power status Pressure waveform section Network status Fresh gas flow section Date and time display section system powered on/off Monitoring parameter section Freeze Function key setting section Name display section Ventilation mode setting section Physiological alarm message section Ventilation mode parameter setting section...
Page 35: Respiratory Humidification System
Respiratory Humidification System 2.5.2 Recommended using the respiratory humidification system which has CE certification when operate the neonatal ventilator. Notes For more information about the above respiratory humidification system, please refer to the  User Manual. Serial Port 2.5.3 The symbol on the back housing indicates the serial port.
Page 36 grounding system is damaged, the equipotential grounding system serves as the safety function of the protective grounding wire. Please check whether the ventilator is in good condition before each use. Warning If the protective grounding system is not stable, please use the internal power supply. ...
Page 37: Chapter3 Basic Operations
Chapter3 Basic Operations Warning The system will trigger alarm to indicate the potential endangers for patients. Please  determine the cause of each alarm to ensure the safety of patients. Do not cover the device or conduct any other operation which may have an adverse impact. ...
Page 38: Alarm Test
Warning Before use, please make sure the ventilator is in good connected and condition and  conduct the pre-operation performance test. If any problem occurs in the performance test, please do not use the ventilator but contact our authorized service representative for further assistance! Equipped with built-in rechargeable battery, the ventilator can continue to work in ...
Page 39: Fio2 Alarm Test
3. Set 【 Pmean】 to 【High、 Low limit】： On user interface， select 【 Alarm】 Menu→ 【Alarm setup】→【Pmean】to【High、Low limit】，and set the low alarm limit to 5cmH2O， the high alarm limit to 10cmH2O. 4. Observe the alarm prompt area on the screen to ensure the occurrence of 【Pinsp too low】 alarm.
Page 40: Set The Alarm Volume, And Key Volume
Observe the alarm prompt area on the screen to ensure the occurrence of 【FiO2 too high】 alarm. Select 【FiO2】 → 【Low limit】 ,set the low alarm limit above the monitor parameter of FiO2 to ensure the alarm of【FiO2 too high】is removed. Restore the setting alarm limit to the default Setting Alarm Limit 3.3 Set the Alarm Volume, and Key Volume Turn on the ventilator.
Page 41 Figure 3-2 Alarm high and low interface Figure 3-3 Alarm high and low interface Note 1: The alarm high and low limits for 【ventilator】 parameters are described in the "Alarm Settings" section of the chapter. Warning  Before use, please make sure the current alarm limit is suitable for the patient. The alarm limit can be set automatically (default) or manually.
Page 42: Set The Nurse Call
3.5 Set the Nurse call See "Nurse call" in Section 6.6. 3.6 Set the Manual Ventilation Time 1. Turn on the ventilator. 2. At the user interface, select 【Menu】 → 【Setting】 → 【Breath Set】→ 【Manual Time】to set the manual ventilation time. Figure 3-4 Manual ventilation setting interface 3.7 Set Calibration 1.
Page 43 Figure 3-5 Calibration interface 43 / 115...
Page 44: Set The Pressure Generator Type
3.8 Set the Pressure Generator Type There are two ways to set the pressure generator type:  General setting mode: 1. Turn on the ventilator. 2. At the user interface, select【Menu】 →【Setting】 →【Breath Set】 →【Pressure Generator Type】 to set the pressure generator type. Figure 3-6 Pressure generator type setting interface ...
Page 45: Set The Trigger Sensitivity
Figure 3-7 Pressure generator type setting quick setup interface Warning The parameter should be consistent with the type of pressure generator connected to  the breathing circuit. 3.9 Set the Trigger Sensitivity 1. The default triggering sensitivity grade is【level 8】. 2.
Page 46: Freeze
Figure 3-8 Trigger sensitivity setting interface Note Insperatory triggering and resperatory monitoring can be checkedin【NCPAP】,  [SNIPPV】 mode, if the resperatory is unreliable or there is no insperatory triggering, please check the sensitivity level in【Set the trigger sensitivity】. The trigger sensitivity setting should be set according to the patient's spontaneous ...
Page 47: Exit The Freeze State
longer refreshed. The data in the parameter area is refreshed normally. Exit the freeze state 3.10.2 In the freeze state, press the【Freeze】 to exit the freeze state. In the freeze state, if you do not perform any operation on the ventilator for more than 3 minutes, the system will automatically exit the freeze state.
Page 48: Neonatal Ventilator Parameter Settings
Figure 3-11 Screenshot function icon 3.13 Neonatal ventilator parameter settings The setting of ventilation parameters of neonatal ventilator is mainly operated by "control knob" and touch screen point control, and the parameters of current confirmed mode are displayed in blue, and the parameters of unconfirmed mode are displayed in green. Figure 3-12 Ventilation parameter setting interface Note All parameters are calculated from real-time flow and pressure waveform data.
Page 49: Set The Oxygen Concentration
Set the Oxygen Concentration 3.13.1 1. Select ventilation mode →【Oxygen concentration】 2. Press the control knob or touch to select the parameter and turn the knob to set【Oxygen Concentration】 to the appropriate value. 3. Press the control knob or touch the parameter to confirm the set value. Figure 3-13 Oxygen concentration setting interface Note [Oxygen concentration】...
Page 50: Set The Apnea Time
Fig 3-14 CPAP setting interface Note 【CPAP】 is available for NCPAP mode only.  Set the Apnea time 3.13.3 1. Select【SNIPPV】mode menu→【Apnea time】。 2. Press the shuttle knob or touch to select the【Apnea time】to a suitable value. 3. Press the control knob or touch the parameter to confirm the setting. Fig 3-15 Apnea time setting interface Attention 【Apnea time】only can be set in【SNIPPV】modes.
Page 51: Set The Pinsp
Fig 3-16 Tinsp setting interface Attention 【Tinsp】can be set in【NIPPV】、【SNIPPV】modes.  Set the Pinsp 3.13.5 1. Select the menu of vent mode→【Pinsp】。 2. Press the shuttle knob or touch to select the【Pinsp】to a suitable value. 3. Press the control knob or touch the parameter to confirm the setting. Fig 3-17 Pinsp setting interface Attention 【Tinsp】can only be set in【NIPPV】and【SNIPPV】modes.
Page 52: Set The Rate
Fig 3-18 PEEP setting interface Attention 【PEEP】only can be set in【NIPPV】and【SNIPPV】modes.  Set the Rate 3.13.7 1. Select the menu of vent mode→【Rate】. 2. Press the shuttle knob or touch to select the【Rate】to a suitable value. 3. Press the control knob or touch the parameter to confirm the setting. Fig 3-19 Rate setting interface Attention 【Rate】only can be set in【NIPPV】mode.
Page 53: Set The Backup Frequency
Attention 【Manual pinsp】only can be set in【NCPAP】modes.  In 【NIPPV】and 【SNIPPV】vent modes,the default manual ventilation parameter  is 【Pinsp】. Set the Backup frequency 3.13.9 1. Select the menu of【SNIPPV】vent mode→【Rate】. 2. Press the shuttle knob or touch to select the【Rate】to a suitable value. 3.
Page 54 Fig 3-22 NCPAP ventilation mode interface Attention When the breathing sensor is off, the functions of the NCPAP mode are not available.  3.14.1.2 Select NIPPV mode 1. Select【NIPPV】→Set【O2%】、【Pinsp】、【PEEP】and other parameters. 2. Select【NIPPV】→【Confirm】 to enable the NIPPV mode. 3. The current model showing at the upper left corner of the interface shall be “NIPPV” after starting NIPPV mode.
Page 55 3.14.1.3 Select SNIPPV mode 1. Select【SNIPPV】→Set【O2%】、【Pinsp】、【PEEP】and other parameters. 2. Select【SNIPPV】→【Confirm】 to enable the SNIPPV mode. 3. The current model showing at the upper left corner of the interface shall be “SNIPPV” after starting SNIPPV mode. Fig 3-24 SNIPPV ventilation mode interface Attention When the breath sensor is in the Off state, the SNIPPV mode is disabled.
Page 56: Introduction To Ventilation Modes
Introduction to Ventilation Modes 3.14.2 3.14.2.1 NCPAP Vent Mode Fig 3-25 NCPAP Vent waveform In NCPAP (nasal continuous positive airway pressure) vent mode, the ventilator calculates the flows of O2 and air transmitted according to the preset【CPAP】 and【FiO2】; the continuous air-O2 mixture flowing through the positive pressure generator provides a positive airway pressure higher than the atmospheric pressure to the patient with spontaneous respiration throughout the respiratory cycle.The device achieves real-time monitoring and feedback of...
Page 57 3.14.2.2 NIPPV vent Mode Fig 3-26 NIPPV vent waveform In NIPPV (nasal intermittent positive pressure ventilation) vent mode, the ventilator intermittently outputs inspiratory pressure according to the preset【Rate】; it outputs inspiratory pressure within the inspiration time (Tinsp) and maintains the positive end-expiratory pressure (PEEP)within the expiration time.
Page 58 3.14.2.3 SNIPPV vent Mode Fig 3-27 SNIPPV vent waveform In SNIPPV (synchronized nasal intermittent positive pressure ventilation) vent mode, the patient's inspiration is monitored by the abdominal respiration sensor according to the set trigger sensitivity. When inspiration is triggered, the interface will give a "patient trigger" prompt, and output inspiratory pressure during one period of inspiration time synchronously;...
Page 59: Manual Ventilation
Pinsp  PEEP  FiO2  Tapnea  Rate  Tinsp  Manual Vent (manual)  Attention Maintain the Pinsp in NIPPV and SNIPPV mode.  Manual Ventilation 3.14.3 You can use the key to apply Manual ventilator to patient in any mode. Click to enter the continuous manual ventilation state.
Page 60 Fig 3-28 Parameter monitoring interface Three pressure units are available for your selection, including【Kpa】、【cmH2O】 (default) Menus and【mbar】.You can select【】→【Setting】→【Paw Unit】to select a pressure unit. Fig 3-29 Pressure unit setting interface 60 / 115...
Page 61: Pressure Waveform Monitoring
Pressure waveform monitoring 3.15.2 At non-standby interfaces, you can observe the real-time airway pressure waveform. See the figure below: Fig 3-30 Pressure waveform monitoring interface Two wave modes are available for your selection, including【Fill】( )、【Scan】.You default can select【Menus】→【Setting】→【Wave mode】to select wave mode。 3-31 Wave mode setting screen 3.16 Spontaneous Respiration Monitoring Respiration sensor is an optional function.
Page 62: Pattern Setting
Fig 3-32 Screen for setting respiratory sensor monitoring switch Attention Please fully test it before using the respiration sensor for the first time or after replacing it.  If you set 【 Respiration Sensor Monitoring】 to 【Off】 , the SNIPPV mode will be disabled. ...
Page 63: Screen Configuration
Fig 3-33 Pattern setting interface Attention  When the pattern is set to 【Day】, the alarm sound is 6 by default. The backlight brightness is 6 by default and can be adjusted from 1 to 9. When the pattern is set to【Night】, the alarm sound is 3 by default. The backlight ...
Page 64: Software Version Information
Fig 3-35 Time configuration screen 3.20 Software version information You can know the software version information of the ventilator,as shown in the following figure. Fig 3-36 Version information interface 3.21 Manufacturer setting Select【System Setup】→【Manufacturer setting】. (Please ask the merchant for the password) 64 / 115...
Page 65: Turn Off The Ventilator
3.22 Turn Off the ventilator Please follow the steps below to turn off the ventilator: (1) Make sure it is time to stop using the ventilator. (2) Press and hold the power key to turn off the ventilator. Or in the operation mode, press and hold the key to call up the shutdown dialog, and confirm to turn it off.
Page 66: Chapter4 Pre-Operation Examination
Chapter4 Pre-operation Examination Warming Please read this manual and understand the operation and maintenance instruction before  using the ventilator. Do not use it but contact us if the ventilator fails in the pre-operation examination.  Do not use it if the ventilator fails in the system check or system test or has any fault. ...
Page 67: Before The Ventilator Is Used By The First Patient Of The Day
Before the ventilator is used by the first patient of the day 4.1.2 1. Check whether the require first-aid device is ready for use and in good condition. 2. Check whether the ventilator is in good condition and its components are all connected properly.
Page 68: Chapter5 Installation And Connection
Chapter5 Installation and Connection Warming The ventilator should be installed by an authorized and trained technician or engineer.  Do not use any antistatic or conductive tubes for the ventilator.  5.1 Device Installation Assemble the Trolley 5.1.1 1. Use screws to fix the support column to the base as shown in the figure. 68 / 115...
Page 69: Assemble The Arm
Fix the tray to the support column as shown in the figure. 3. Hold the main engine with both hands and align the four grooves and footing to put the breathing engine, as shown in the picture: 4. Fasten the knob by hand, as shown in the picture: Assemble the Arm 5.1.2 1.
Page 70: Assemble The Water Bag Support
2. Insert the lower end of the arm into the mounting hole and then tighten the fixing knob. 3.Adjust each fastener until the arm reaches an appropriate angle and position. Assemble the Water Bag Support 5.1.3 Please refer to the second step in 5.1.2 Assemble the Arm to install the water bag support. Assemble Fuse 5.1.4 Plug the fuse into the main power port, please refer to 5.1.5.1 Connect the power cord, as...
Page 71: Patient Connection
5.1.5.2 Attach the power cord Use the screw driver to attach the safety catch by referring to 5.1.5.1 Connect the power cord, as shown in the figure: 5.2 Patient connection Connect the Adbominal resperation sensor 5.2.1 As shown in the figure, directly insert the respiration sensor tube into the respiration sensor interface.
Page 72: Connect Respiration Circuit
Connect respiration circuit 5.2.3 As shown in the figure, insert the breathing circuit tube into fresh gas outlet . 2. Finish the installation. Connecting the Abdominal Respiratory Sensor 5.2.4 1. Connect the respiratory sensor to the respiration sensor box connector; 2.
Page 73: Install Pressure Generator And Nasal Cannula （Or Nasal Mask
Place the abdominal respiration sensor on the side of the abdomen.  Install Pressure Generator and Nasal Cannula （or Nasal Mask） 5.2.5 The specific installation steps are shown as follows: 1. Use the measuring tape and select the nasal cannula or nasal mask of the size suitable for the patient.
Page 74 2. Select the bonnet of suitable size. Do not choose a too small one and it must fit loosely. Put the bonnet onto the baby’s head, open the Velcro-strip and guide the ribbon of the bonnet through the pointing loops of the nasal cannula or nasal mask, as the figure shown below: Attention Adjust the bonnet possibly close to the baby’s eyes in oder to better fix the pressure generator.
Page 75 fixation of the nCPAP devices. Warming Do not pull the ribbons of the bonnet hard and take care that the ribbons should not be tightened too  much. Please insert the nasal cannula only halfway into the nose.  If the nasal cannula and nasal mask are used alternatively, the contact site between the nasal ...
Page 76 5.Periodically check the machine parameters and the fixation of nasal cannula/ nasal mask. Attention Periodically check the placement and fixation of pressure generator and the components for pressure  sores. It is clinically suggested to nurse the patient once every 1 to 2 hours. Periodically check the nasal cannula and nasal mask for secreta to avoid occlusion.
Page 77: Chapter6 Alarm
Chapter6 Alarm 6.1 Overview When the ventilator fails to monitor the patient due to any fault or any abnormal vital sign change in the patient, the ventilator will prompt the medical workers with alarm sound, alarm indicator and alarm message. Warming If different alarm presets are used for the same or similar devices in any one area, there may be ...
Page 78: Alarm Level
limit or any physiological anomaly occurs to the patient, the ventilator will trigger a physiological alarm. Physiological alarm messages are displayed at the physiological alarm message section on the top of the screen. 2. Technical alarm Technical alarm is also called system error message. If any system function does not work or the measured result is not accurate due to improper operation or system malfunction, the ventilator will trigger a technical alarm.
Page 79: Alarm Indicator
Alarm Indicator 6.2.1 The alarm indicator will flash at different frequencies and in different colors to indicate different levels of alarms.  High priority alarm: flashes quickly in red.  Medium priority alarm: flashes slowly in yellow.  Low priority alarm: remains on in yellow. Alarm Sounds 6.2.2 The System will give different sound sequences to indicate different levels of alarms.
Page 80: Set The Alarm Volume
6.3 Set the Alarm Volume At the user interface, select【Alarm】→【Sound】and then set alarm sound to level 1~8 (lowest-highest). Warming Patient monitoring should not solely reply on the alarm sound. A low alarm volume could  cause danger to the patient. Please pay close attention to the patient’s actual clinical condition.
Page 81: Exit The Alarm Paused State
Attention In Alarm Paused state, the alarm indicator and alarm message will continue to work.  In Alarm Paused state, the ventilator will auto exit the Alarm Paused state once a new  technical or physiological alarm is triggered. When the 120s countdown is over, the ventilator will exit the Alarm Paused state. ...
Page 82: Countermeasures For Alarm
【Normally opened】：Use the normally opened signal to trigger the nurse call function. 【Normally closed】：Use the normally closed signal to trigger the nurse call function. 5) Set the alarm level：Select the alarm level that triggers the nurse call signal. Warming The nurse call function should not be used as a primary alarm notification source. ...
Page 83: Chapter7 Physiological And Technical Alarm
Chapter7 Physiological and Technical Alarm This Chapter lists some important physiological and technical alarm messages. Please note that in this Chapter, “alarm level” refers to the priority alarm level (H – high; M – medium; L – low). If any alarm still exists after you take the recommended countermeasure, please contact us for service.
Page 84: Technical Alarm
pressure is less than PEEP, the lower alarm limit setting value lasts longer than the alarm delay parameter. Increase the positive end expiratory pressure monitoring value or lower PEEP alarm limit The oxygen concentration monitoring value is greater than the FiO2 alarm upper limit setting value.
Page 85 valve is faulty contact the manufacturer for maintenance. The air Air proportional valve connection or control failure. Ensure proportional that the connection is reliable. If the fault persists, contact the valve is faulty manufacturer for maintenance. The oxygen flow Ensure that the connection is reliable. If the fault persists, sensor is faulty contact the manufacturer for maintenance.
Page 86 Manual pressure Manual ventilation is being used. The duration of In the SNIPPV -mode, the time of asphyxia is shorter than the apnea time is respiratory cycle. Set the time of suffocation longer than the less than the respiratory cycle. respiratory cycle The battery is The battery level is less than 30%.
Page 87: Chapter8 Trend And History
Chapter8 Trend and History 8.1 Trend Table The trend table lists the historical physiological parameter at specific time point and describes the change trend of parameter values with a table.It covers such parameters as:Ppeak、Pmean、 PEEP、FiO2 and Flow.It can save up to 60h (60 continuous operation hours) historical date for each parameter.The trend table will be zeroed when the ventilator is turned off.
Page 88: Trend Graph
Move up Click【】button.The cursor moves a record in the direction indicated by the arrow. Move down Click【】button.The cursor moves a record in the direction indicated by the arrow. 8.2 Trend Graph The trend chart uses a curve (each of its points represents the physiological parameter value at the relevant point in time) to describe the change trend of the parameter values at specific point in time.It can save up to 48h (48continuous-operation hours) historical data for each of such parameters as oxygen concentration, CPAP and PEEP at a resolution of 5s.
Page 89: Alarm History
Move left Click【】button.Cursor to the left. Move right Click【】button.Cursor to the right. 8.3 Alarm History The System can save up to 500 historical alarm records. When the 501st alarm occurs, the earliest alarm record will be deleted. The alarm history contains both technical alarm records and physiological alarm records.
Page 90: Screen Snapshot Export
When the alarm sound stops, you can enter the alarm history to check the cause of the  alarm. 8.4 Screen snapshot export Exporting screen snapshots means exporting saved screen snapshots from the ventilator. The exported file format is BMP. The ventilator can store up to 50 screen shots. Perform the following steps to export the screen: 1.
Page 91: Chapter9 Cleaning And Disinfection
Chapter9 Cleaning and Disinfection Warming  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 potassium hydroxide).
Page 92: 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 93 Accessories ) Heated Breathing Circuits Single use Abdominal respiration sensor Single use Low-Pressure Hose Assembliesfor as necessary Refer to the maintenance informations use with Medical provided by the vendor. Cleaning methods (Wipe and Bath Immersion): ① Wipe: Wipe with a damp cloth immersed in alkalescent detergent (soap water, etc.) or alcohol solution and then wipe off the remaining detergent with a dry lint free cloth.
Page 94: Chapter10 Maintenance
Chapter10 Maintenance 10.1 Maintenance Principle Do not use the ventilator if it has any fault. Please try to have all repairs done by our authorized service representative. The component replacement and maintenance can be also done by other qualified professionals. Please test whether the ventilator functions well after each repair.
Page 95: Oxygen Sensor Calibration
Replace the built-in battery. Please contact our customer service Once every 3 years department for more help. 10.3 Oxygen Sensor Calibration 1. At the standby interface, select 【O2 Cal.】to enter the oxygen calibration state as shown in the figure below: Attention Calibration is required when there is big difference between the measured value and set ...
Page 96: Oxygen Sensor Maintenance And Replacement
 Charging method: in power-off state, connect the ventilator to the AC power to turn on the charging indicator and enter the charging state. Attention In power-on or standby state, the ventilator should be charged for 10 consecutive hours.  Please charge it once every 3 months if the ventilator remains idle for long, or the built-in ...
Page 97: Pollution-Free Disposal And Recycling
10.6 Pollution-free Disposal and Recycling  Neonatal ventilators that are no longer in use can be sent back to the distributor or manufacturer where you purchased the product for appropriate recycling.  Used batteries and oxygen batteries may be disposed of in accordance with applicable laws and regulations.
Page 98: Chapter11 Accessories
Chapter11 Accessories Warming Please use the accessories recommended in this Chapter only to avoid causing  inaccurate measurements or product damage. Do not reuse any disposable accessory, which can cause reduced performance or cross  contamination. Do not use any accessory if it or its package is damaged. ...
Page 99: Chapter12 Specification
Chapter12 Specification 12.1 Gas Circuit System Diagram Gas Circuit Diagram 12.1.1 Fig 12-1 Gas Circuit Diagram Components 12.1.2 Description Description High pressure oxygen inlet Check Valve Filter Pressure Switch Check Valve Pressure regulating valve Pressure Switch Proportioning solenoid valve Pressure regulating valve Flow Sensor Proportioning solenoid valve Air-oxygen mixing chamber...
Page 100: Electrical System Diagram
Note  2-Filter :Used to filter particles in high-pressure oxygen, the filter is made of sintered copper material, and the filter particle diameter is 20um-30um. (The high-pressure oxygen itself is also cleaned and filtered, and this filter acts as an additional filter) . ...
Page 101: Classification Under Iec60601-1 And Applicable Standards
Fuse RJ45 Switching power supply（18V/100W） Safety valve 14.8V Lithium battery Zero valve 1 Monitor board Zero valve 2 Abdominal respiration Acquisition plate Air/oxygen switching valve Calibration serial port Air flow sensor Key-press panel Oxygen flow sensor Alarm indicator board Pressure switch 1 Shuttle board Pressure switch 2 Main control board...
Page 102: Power Cord
Input voltage 100 - 240 V～ Input frequency 50 - 60 Hz Input current 2.5A@115Vac,1.25A@230Vac Fuse T3.15AH250V Power cord 24V /100W External DC power Input voltage 12-24 Battery Type of battery lithium battery Rated battery voltage 14.8VDC Battery capacity 5200mAh 30min or longer (as for the fully charged new battery, the ventilator will be auto powered off 30min after the Power-off delay...
Page 103: Emc And Radio Regulatory Compliance
Guidance and manufacture’s declaration - electromagnetic emissions The Neonatal ventilator (Crius V5A,Crius V5B) is designed to work in the electromagnetic environment specified below. Please use it in the following electromagnetic environment only.
Page 104 IEC 61000-3-3 Guidance and manufacture’s declaration - electromagnetic immunity The Crius V5A/Crius V5B Neonatal ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
Page 105 Note: U T is the AC. mains voltage prior to application of the test level. Guidance and Manufacturer’s declaration - electromagnetic immunity The Crius V5A/Crius V5B Neonatal ventilator is designed to work in the electromagnetic environment specified below. Please use it in the following electromagnetic environment only.
Page 106 d = 1.2 p 80 MHz to 800 MHz d = 2.3 p 800 MHz to 2.5 GHz Where, maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in Radio-frequency meters (m).
Page 107: Physical Specifications
Recommended separation distance between portable and mobile RF communications equipment and the Crius V5A/Crius V5B neonatal ventilator The Crius V5A/Crius V5B neonatal ventilator is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the...
Page 108: Environmental Specification
Caster 4 -inch Display screen Type TFT LCD color touch-screen Size 12.1 inch Resolution 1024×768 (pixel) Brightness Adjustable LED indicator Green LED AC、DC indicator When the system is connected to an external AC or DC power supply, the system lights up. Green LED When the AC and DC are connected, the battery indicator is Battery indicator...
Page 109: Performance Specifications
-20℃～55℃（oxygen Transport battery： 0％～95％ 50.0kPa～106.0kPa and storage -20℃～50℃） 12.8 Performance Specifications Gas Circuit 12.8.1 Gas supply Clean, dry medical air and oxygen Gas connection NIST Gas inlet pressure 280～600kPa Gas supply 12.8.2 Fresh gas Display range and accuracy Range of air 0～30L/Min Range of oxygen 0～30L/Min...
Page 110: System Principle And Parameter Specifications
12.9 System Principle and Parameter Specifications Principle 12.9.1 The System controls the gas flowing from the oxygen and air solenoid valve to the patient. The continuously constant air-oxygen mixture will be heated and humidified by the humidifier and then reach the patient’s nose (connected through the nasal cannula or nasal cover) through the positive pressure generator featured by Coanda Effect and flow switching principle.
Page 111 Ventilator performance Actuating 280～600 kPa pressure monitoring parameter 0～100% Pinsp/PEEP Ppeak -10～100 cmH2O Ppean 1:1～1:10 T.exp 0.4～30s Rate 0～200 bpm Noise Value Noise Value Sound pressure level:≤ 48 dBA with uncertainty of 2 dBA as measured； Sound power level:≤ 50 dBA with uncertainty of 2 dBA as measured. Parameter Accuracy Pressure CPAP：±0.2cmH2O or ±2% of the set value, whichever is greater.
Page 112: Principle And Specifications Of Oxygen Sensor
less than 50ms） Alarm set Parameters Range Remark 2.5～25cmH2O Upper alarm The upper alarm limit limit should exceed the lower Ppeak Lower alarm 0.5～（Upper alarm alarm limit. limit－2）cmH2O limit 2.5～25cmH2O Upper alarm The upper alarm limit limit should exceed the lower Pmean Lower alarm 0.5～（Upper alarm...
Page 113: Specifications Of Oxygen Sensor
surface. The metal electrode will be consumed gradually in the oxidation process. The oxygen monitoring function uses the signal processing and analysis circuit to convert the battery signal into the relevant oxygen concentration value (percentage). The System will display such value and compare it with the preset alarm limit. If such value goes beyond the alarm limit, the ventilator will trigger an alarm.
Page 114: Alarm Specifications
12.11 Alarm Specifications Alarm Alarm sound pressure 45dB-85dB Note: Under the default alarm problem volume level, the high priority alarm volume is not less than 60dB. In the alarm sound pressure level, the high level is higher than the low level, that is, low priority <...
Page 115 Appendix A Manufacturer-specific Ventilation-mode systematic coding Explanation naming of the ventilator's scheme in Annex E of ISO 19223:2019 ventilation modes NCPAP CPAP Nasal continuous positive airway pressure NIPPV IMV-PC Nasal intermittent positive pressure ventilation SNIPPV SIMV-PC Synchronized nasal intermittent positive pressure ventilation 115 / 115...

This manual is also suitable for:

Crius v5b