$V300/350 Ventilator Service ManualIntellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual, This manual ‘may refer to information protected by copyrights or patents and does not convey any license ‘under the patent rights of Mindray, nor the rights of others, Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties, Mindray intends to maintain the contents of this manual as confidential information Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. mindray | Ll aug MINDRAY are the registered trademarks or trademarks owned by Mindray in China and other countries, All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners, Contents of this manual are subject to changes without prior notice. Revision History This manual has a revision number. This revision mumber changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. Revision 1.0 is the initial release of the document. Revision number: 3.0 M Releasetime: 2016-07 © Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd, All rights reserved.Preface Manual Purpose This manual provides detailed information about the assembling, dissembling. testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personal injury. This manual is based on the maximum configuration. Therefore, some contents may not apply to your monitor. If you have any question, please contact our Customer Service Department. Intended Audience This manual is geared for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the ventilator machines. Password A password is required to access different modes within the ventilator machine. ‘M User maintenance: 1234 Factory maintenance: 1118Table of Contents 1 Safety 1.1 Safety Information... 1.1 Dangers 1.1.2 Wamings ... 1.1.3 Cautions LA Notes. 1.2 Equipment Symbols. 2.1 Pneumatic Circuit 2d 2.1.1 Overview of the Pneumatic System .onnmnnnnmnnnnrnnnnnnn 21 2.1.2 Pneumatic Circuit Diagram, 2.1.3 Theory of Operation of the Pneumatic Subsystem. 2S 2.2 Electrical Circuit so 2.2.1 Overview of the Hardware Boards, 2.2.2 Electrical Circuit Diagram 2.2.3 Power Supply System... 2.24 Board Function. 3 Checkout and Test. 3.1 System Inspection a.m 3.2 Power Failte Alarm Test (Extemal Power and Buzzer) 3.3 02 Pipeline Test 3.4 System Test 3.5 Spontaneous Breathing Test. 3.6 Humidifier Performance Test 3.7 Alarm Tests 3.7.1 Prepare for Alarm Tests. 3.7.2 Battery in Use Alarm Test 3.7.3 Power Failure Alarm Test. 3.7.4 Paw Too High Alarm Test 3.7.5 TVe Too High Alarm Test. 3.7.6 TVe Too Low Alann Test 3.7.7 MV Too High Alarm Test 3.7.8 MV Too Low Alarm Test 3.7.9 PEEP Too Low Alarm Test. 3.7.10 Airway Obstructed Alarm Test 3.7.11 Apnea Alarm Test. 3.7.12 fiotal Too High Alarm Test 3.7.13 Fi02 Too High Alarm Test. 3.7.14 Fi02 Too Low Alarm Test,3.7.15 EtCO2 Too High Alarm Test 3.7.16 EtCO2 Too Low Alann Test... 3.7.17 SpO2 Too High Alarm Test 3.7.18 Sp02 Too Low Alarm Test 3.7.19 PR Too High Alarm Test orn 3.7.20 PR Too Low Alarm Test 3.8 Function Tests . 43.8.1 Checking the Standard Working Mode 3.8.2 Checking the Tidal Volume 3.8.3 Checking the Trigger Function... . 3.8.4 Checking Spontaneous Breathing in CPAP/PSV Mod... 3.8.5 Sidestream CO2 Test and Calibration 3.8.6 Mainstream CO2 Test. 3.8.7 SpO2 Test... 3.8.8 Checking the Special Functions. 3.9 Electrical Safety Inspection. 3.9.1 Electrical Safety Inspection Test. 3.9.2 Electrical Safety Inspection Form 4 Maintenance Menu and Software Upgrade. 4.1 User Maintenance 4.1.1 Overview... 4.1.2 Setting... 4.1.3 Defaults Settings. 4.1.4 Data Transfer. 4.1.5 Interface Setting. 4.1.6 System Information. 4.1.7 CO2 Maintenance. 4.2 Factory Maintenance... 4.2.1 Overview 4.2.2 Factory Setup 4.2.3 Factory Calibration... son 413 4.2.4 Calibration Data. Ald 4.2.5 Data Monitoring 4-15 4.2.6 Diagnosis Test 416 4.2.7 Event Logbook. - - AIT 4.3 Software Upgrade and Software Function Activation 418 4.341 Network Upgrade... 418 4.3.2 USB Memory Upgrade cocoon A28 4.3.3 Function Activation. 451 43.4 Function Trial. 435 '§ Maintenance and Calibration $5.1 Equipment Maintenance...5.1.1 One-year Replaceable Parts 5-2 5.1.2 Periodically-Maintained Parts. a 5.2 System Test 57 5.2.1 System Check. Check the Mechanical Ventilation Stat.... 5.2.3 Check the Correctness of Sensor Zero Point. 5.24 Check the Accuracy of Flow Sensor 5.2.5 Check the Accuracy of Pressure Sensor: 5.3 Syste Calibration... “ 5.3.1 Flow Calibration (User). 5.3.2 Flow Calibration (Factory) un 5.3.3 02% Calibration (User) 5.34 02% Calibration (Factory). 5.3.5 Mainstream CO2 Zeroing (User)... 5.3.6 Sidestream CO? Zeroing (User). 5.3.7 Sidestream CO2 Calibration (User) 5.3.8 Pressure and Flow Zeroing (Usea) 5.3.9 Pressure and Flow Zeroing (Factory) 5.3.10 Pressure Calibration Factory) 11 Expiratory Valve Calibration (Factory)... 5.3.12 Air and 02 Calibration Factory) . 6 Troubleshootin, 6.1 Introduetion.. 6.2 Troubleshoot System Check Fairs. 6.3 Technical Alarms and Diagnosis... so 63.1 Main Board Related Technical Alarms. 6.3.2 Keyboard Related Technical Alarms. 6.3.3 VOM Related Technical Alam... 6.3.4 Auxiliary Monitor Board Related Technical Alarms 63.5 Power Board Related Technical Alarms. 6-10 6.3.6 CO2 Related Technical Alarms sol 6.3.7 SpO2 Related Technical Alam... sennnnsnnssnnnninnnsenee 612 6.4 Failure Code Table 6-13 6.5 Envor Information... os O18 6.6 Diagnostic Test rcs 619 6.6.1 Preparations before Using the Valve Test Too G19 6.62 Correspondence between the Sensors & Valves on the Valve Test Seren and the ‘Components... so enn 619 6.63 Troubleshooting Methods by Using Valve Test Tol. 621 6.7 Pneumatic System Failutes nese 6.7.1 Commonly Used Devices and Tools 6.7.2 Pneumatic Failures List. 6.7.3 Gas Supply Subsystem.6.7.4 Blower Fan and Flow Control Subsystem, 6.7.5 Safety Valve Assembly... “ nn 6.7.6 Expiration Valve Assembly 6-38 6.7.7 02 Sensor Has Great Measurement Error 6-40 6.8 Hardware and Electrical System Failures... 64] 7 Repair and Disassembly sanmennnennemenmnmnnnnnnnnmnmnmnennmnmnnanns TH 7.1 Prepare for Disassembly 72 7.1 Tools... 7.1.2 Preparations... disassemble the Service PAIS .nnn 7.2.1 Remove the Lithinm Battery 7.2.2 Replace the 02 Sensor 3 Remove the HEPA Filter and Fan Dust Screen 7.2.4 Remove the Main Unit Dust Screen 7.2.5 Remove the Disinfectable Expiratory Valv Assembly and Safety Valve Detachable Part 712.6 Remove the Expitatory Valve Diaphragm and Fxpirtory Check Valve 7 7.2.7 Remove the Parts of the Disinfectable Part of the Safety Valve 7 8 Remove the Upper Housing Assembly 7.2.9 Remove the Speaker... 7210 Remove the WIFI Module (Optionad. 2.11 Remove the $p02 Module (optional). 7.2.12 Remove the Display Assembly... 7.2.13 Remove the Main Unit Front Housing 14 Remove the Monitoring Board Assembly... 172.15 Remove the Display Rear Housing and Key Control Board 7.2.16 Remove the Alarm Light Board 17 Remove the Display Assembly... 7.2.18 Remove the Touchscreen 7.2.19 Remove the Encoder 7.2.20 Replace the Pressure Sensor Filter... on 7.2.21 Remove the Safety Valve Seat Assembly... 7.2.22 Remove the Electromagnet 13 Remove the Air Flow Sensor... 7.2.24 Remove the Sensor Adapter Board . 7.2.25 Remove the 02 Sensor Seat Assembly 7.2.26 Remove the Kernel Assembly... 7.2.27 Remove the AC-DC Power Board... 7.2.28 Remove the DC-DC Power Board 29 Remove the Fan. . 72.30 Remove the AC Power Socket 7.2.31 Remove the DC Input Socket. 7.2.32 Remove the Expiratory Valve Seat Assembly...7.2.33 Remove the Expiratory Valve Voiee Coil Motor 7.2.34 Remove the Sidestream CO2 Module (optional) 7.2.35 Remove the Blower Box Assembly 7.2.36 Remove the Vacuum Sensor Board 37 Remove the Inspiratory Valve Assembly... 7.2.38 Remove the Filter Net for Inspiratory Valve..... 7.2.39 Remove the 02 Inlet Assembly... os 7.2.40 Remove the Proportional Valve and Nebulizer Valve 7631 7.2.41 Remove the Pressure Regulator Assembly., 732 7.2.42 Remove the 02 Flow Sensor. 7-33 7.2.43 Remove the Low Pressure O2 Connector... 7-34 7.2.44 Remove the Battery Adapter Board 7.2.45 Remove the Rear Housing Assembly. 46 Remove the CO2 Parameter Connector Panel (Optional).n.nennnmnnenn 36 7.2.47 Remove the WIFI Antenna (optional) 7-36 7.2.48 Remove the $p02 Connector (optional) 7637 7.2.49 Remove the Trolley Support Table Assembly .....sumennnmnnnnnnn TB 7.2.50 Remove the Trolley Handle Assembly. 738 7.2.51 Remove the Trolley Column 7239 7.2.52 Remove the Trolley Base ASSeMbIY....nn 7239 7.2.53 Remove the Humidifier Fixing Assembly... 740 7.2.54 Remove the Trolley Cylinder Fixing Assembly. 7-40 7.2.55 Remove the Trolley Lock Control Assemibly Tl 8 Electrical and Pneumatic Connections. 8.1 Pneumatic Connection, 8.1.1 Pneumatic Connecti 8.1.2 Tubes List 8.2 Electrical Connection... 8.2.1 Electrical Connection Diagram. 8.2.2 Electrical Connection List. 9 PAIS snssnnninnnnnenninnininnnnninmnnnnnnninnsnnassnnmsiies SL 9.1 SV300/350/SV350 Ventilator Main Unit Assembly 9.1.1 Exploded View 9.1.2 Patts List. 9.2 Display Assembly 9.2.1 Exploded View 9.2.2 Pants List. 0.3 Display Front Housing Assembly 9.3.1 Exploded View 9.3.2 Parts List 9.4 Kemel Assembly 9.4.1 Exploded View9.4.2 Pants List 9.5 Main Unit Bracket Assembly. 9.5.1 Exploded View 9.5.2 Pats List 9.6 Main Unit Rear Housing Assembly 9.6.1 Exploded View... 9.6.2 Parts List sunennn 9.7 02 Inlet Assembly (NIST) 9.7.1 Exploded View... 9.7.2 Pats List svunnnn 9.8 02 Inlet Assembly (DISS) 9.8.1 Explocled View 9.8.2 Pants List 9.9 Expiration Valve Assembly. 9.9.1 Exploded View 9.9.2 Pants List 9.10 Safety Valve Assembly... 9.10.1 Exploded View 9.10.2 Parts List 9.11 Safety Valve Base Assembly..... 9.11.1 Exploded View 9.11.2 Parts List. 9.12 Safety Valve Detachable Part 9.12.1 Exploded View 9.12.2 Parts List 9.13 Exp. Flow Sensor Sampling Seat Assembly... 9.13.1 Exploded View 9.13.2 Parts List 9.14 Disinfectable Expiration Valve Assembly... 9.14.1 Exploded View 9.14.2 Parts List 9.15 Blower Box Assembly... 9.15.1 Exploded View 9.15.2 Parts List 9.16 Inspiration Valve Assembly... 9.16.1 Exploded View 9.16.2 Parts List.. 9.17 Trolley Assembly 9.17.1 Exploded View 9.17.2 Parts List 9.18 Trolley Handle Assembly 00. 9.18.1 Exploded View 9.18.2 Parts List 9.19 Trolley Support Platform Assembly...9.19.1 Exploded View 9-20 9.19.2 Parts List 9.20 Trolley Base Assembly. 9-21 9.20.1 Exploded View 9-21 9.20.2 Parts List 9-21 9.21 Trolley Gas Cylinder Fixed Assembly. 9.21.1 Exploded View 9.21.2 Parts List A Mindray $V300/380 Preventive Maintenance Report..nnnmnnnnnennnessnnse AL A.l Check before Preventive Maintenance... A.2 Preventive Maintenance A. Test afler Preventive Maintenance A4 RemarksFOR YOUR NOTES1 Safety 1.1 Safety Information ZXDANGER © Indicates an imminent hazard that, if not avoided, will result in death or serious injury. A\WaRNING © Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. ZXcauTION © Indicates a potential hazard or unsafe practice that, if uot avoided, could result in minor personal injury or product/property damage. NOTE © Provides application tips or other useful information to ensure that you get the most from your product. FI1.1.1 Dangers ‘There are wo dangers that refer to the product in general, Specific “Danger” statements may be given in the respective sections of this manual, 1.1.2 Warnings Z\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 © Before putting the system into operation, the operator ust verify that the equipment, connecting cables and accessories are in correct working order and operating condition. © To avoid the risk of electric shock, this equipment must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect it from the power line. © Use extermal 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. © Donot place the ventilator adjacent to any barrier, which can prevent cold air from flowing, resulting in equipment overheat. © Donot open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by us only. © Donot rely exclusively on the audible alar system for patient monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient, Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring. © The physiological parameters and alarm messages displayed on the sereen of the equipment are for doctor’s reference only and cannot be directly used as the basis for clinical treatment. © Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach, 12Z\WARNING ‘All staff should be aware that disassembling or cleaning some parts of the ventilator can cause risk of infection. ‘Maintenance mode can only be used when the equipment is disconnected from the patient. Positive pressure breathing may be accompanied by some side effects such as barotrauma, hypoventilation, hyperventilation etc. Using the ventilator in the vicinity of high-frequency electrosurgery units, defibrillators or short-wave therapy equipment may impair correct functioning of the ventilator and endanger the patient. Do not use antistatic or conductive masks or breathing tubes. They can cause burns if they are used near high frequency electrosurgical equipment. ‘Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard due to an oxygen-enriched environment. Ifthe equipment internal monitoring system malt nctions, an alternative plan must be available to ensure adequate level of monitoring. The operator of the ventilator must be responsible for proper patient ventilation and safety under all, circumstances, As required by the relevant rules and regulations, oxygen concentration should be monitored when the equipment is used on the patient. If your ventilator is not configured with such monitoring function or this function Is turned off, use a moniter which complies with the requirements of ISO 80601-2-5S for oxygen concentration monitoring. All analog or digital products connected to this system must be certified passing the specified IEC standards (such as IEC 60950 for data processing equipment and TEC 60601-1 for medical electrical equipment). All configurations shall comply with the valid version of IEC 60601-1. The personnel who are responsible for connecting the optional equipment to the LO signal port shall be responsible for ‘medical system configuration and system compliance with TEC 60601-1 as well. ‘Do not touch the patient when connecting the peripheral equipment via the /O sigual ports or replacing the oxygen cell to prevent patient leakage current from exceeding the requirements specified by the standard. ‘This equipment is uot suitable for use in an MRI environment. When the ventilator gas supply input system fails or has faults, please contact us iumediately for specified personnel to service the ventilator. 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 ventilator getting tilted during the movement. ‘Do not block the air intake vent at the back of the ventilator. 1Z\WARNING To prevent interrupted operation of the ventilator due to electromagnetic interference, avoid using it adjacent to or stacking other devices on it. If adjacent or stacked use is necessary, verify the ventilator’s normal operation in the configuration in which it will be used, To prevent possible personal injury and equiment damage, make sure that the ventilator is secured to the trolley or placed on the safe and smooth surface. To prevent possible eq) crossing thresholds. jent damage, avoid tipping over the ventilator when ‘To prevent possible equiment damage, step down the brake when parking the ventilator. Avoid use of polluted Air. When the equiment uses Air as gas source for ‘ventilation, if the Air is polluted, harmful substance may enter the patient tubes. ‘To prevent patient injury caused by equipmpment malfunction, when the alarm [Technical Error**] occurs, remove the equipment immediately, record failure code, and contact the Customer Service Department. To prevent possible ventilator malfunction, do not spill liquid onto the ventilator: A turbofan can cause gas to be heated, To reduce the temperature of gas inside the tube and prevent patient injury accordingly, make sure that the lenght of patient tube from the humidifier to Y piece is greater than 1.2m. ‘The internal electrical power source is to be used if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt. Nebulization or humidification can increase the resistance of breathing system filters and that you need to monitor the filter frequently for increased resistance and blockage. ‘The ventilation accuracy can be affected by the gas added by use of a nebulizer. ‘The ventilator shall not be used with nitric oxide, For non-invasive ventilation, the exhaled volume of the patient ean differ from the measured exhaled volume due to leaks around the mask. Check if the alarm limit settings are appropriate before taking measurement. ‘The mains plug is used to isolate the ventilator circuits electrically from the SUPPLY MAINS, not to position the ventilator so that it is difficult to operate the plug No modification of this equipment is allowed. Failure to have an alternative means of vent lation such as a self-inflating, manually-powered resuseltator(as specified in ISO 10681-4) with mask can result in PATIENT death if the VENTILATOR fails. Stop using the ventilator and contact us immediately when the buzzer alarms. iZ\WARNING © Under the ambient temperature of 40°C, the inspiratory pressure of the ventilator exceeds 60cmH2O, and the maximum temperature on the surface of breathing mask may exceed 41°C but does not exceed 43°C. © When the ventilator is restalled, or main control board is repalced, perform flow calibration (factory). 1.1.3 Cautions A\cauTion © The ventilator must be inspected and serviced regularly by trained service personnel. © To ensure patient safety, always prepare pulmotor for use. © Always have a spectal person attend and monitor the operation of the equipment once the ventilator is connected to the patient. © During the operation of the ventilator, do not disassemble the inspiratory safety valve and expiration valve unless in standby mode. To ensure patient safety, use only parts and accessories specified in this manual. At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such. products. © Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vieinity of the equipment comply with the relevant EMC requirements. Mobile phone, 3 source of ‘ray equipment or MRI devices are a possible erference 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 flelds, © Before connecting the equipment to the power line, check that the voltage and frequency ratings of 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 drop, impact, strong vibration or other mechanical force. © To clectrically isolate the ventilator circuits from all poles of the supply mains simultaneously, disconnect the mains plug.AXcaution To minimize the risk of fire, do not use low-pressure gas tubes that are worn or contaminated with combustil Ie materials like grease or oil. It s the clinician's esponsibility to ensure that all ventilator settings are appropriate. To prevent possible patient injury, make sure the ventilator is set up for appropriate patient type with the appropirate breathing tubes. Make sure the flow sensor calibration and the system check are performed before you use the ventilator. ‘To prevent possible patient injury, make sure the ventilation parameters is set up properly before ventilating the patient. To ensure the aceuracy of oxygen monitoring, replace an exhausted oxygen cell as soon as possible or use an external moniter that complies with ISO 80601-2- A fan failure could result in oxygen enrichment inside the ventilator and a subsequent fire hazard. To reduce the risk of explosion, do not burn the O2 cell or force the cell open. ‘When ventilating with a mask, avoid high airway pressures. High pressures may cause gastric distension. Peak pressures exceeding 33 emH2O 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 with oxygen between the oxygen source and ventilator. mn at the rear of the ventilator. To reduce the risk of fire, ensure adequate ventilat To reduce the risk of fire, switch off the oxygen source when the ventilator is not in a ventila Avoid putting the ventilator in the storage environment of more than $0°C for a Tong time. Such enviroment m battery and oxygen sensor. damage or shorten the battery life of internal Use the original packing materials to ship the ventilator. To prevent fire hazard, use only specified fuses or fuses with the same type, rated voltage, and rated current to the existing fuses. When replacing fuses, contact the Customer Service Department. ‘The ventilator is intended to be used in the patient environment. Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be connected to the systen Before the ventilator is used for transfer, make sure its casters and brakes are in good condition, 161.1.4 Notes NOTE © Put the ventilator and its accessories in # location where you can easily see the sereen 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 LEC 62304. The possibility of hazards arising from software errors is minimized. © This manual describes all features and options. Your equipment may not have all of them. 1.2 Equipment Symbols ce Battery = Fuse ~~ ‘ACDDC power eee Direct current input = vers indicator light port RS.232 connector ‘Nebulizer connector VGA output connector Oxygen sensor connector Network connector USB connector Power switel Nurse call connector Lock Unlock Oo le- eta High-pressure oxygen supply connector 02 [EE veer tein Low-pressure oxygen supply connector ra > Ventilator gas outlet co Flow sensorExpiration Qe Inspiration ~ AUDIO PAUSED co: C02 module Dmectmamcme | gg | miner Degree of protection Serial number P21 provided by ences Protective earth Caution ground sop e Disassemble the 02 Sp02 module A sensor ‘Type BF applied part. Defibrillation-proof protection against electric shock. ‘The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health, For more detailed information with regard to retuming and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only a ‘The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex T of this directive. Note: The product complies with the Council Directive 2011/65/EU. 1s2 Theory of Operation 2.1 Pneumatic Circuit 2.1.1 Overview of the Pneumatic System ‘The pneumatic system consists of three parts: inspiratory limb, patient tube, and expiratory limb, The inspiratory limb can be further divided into gas supply and nebulizing subsystem, blower and flow control subsystem. and safety valve subsystem. As shown above, the patient tube plays the role of bridge between the inspiratory limb and ‘the expiratory limb. The gas supply and nebulizing subsystem is connected with the patient tube as required to implement the nebulizing function, These subsystems form a closed circuit for the ventilator to implement the ventilation management function 212.1.2 Pneumatic Circuit Diagram 2.1.2.1 Parts List symbol Name Function and Index ‘i Low-Pressure | Low-pressure Air inlet Air inlet Inlet Oe (02 connector. quick connector, compatible Low-Pressure | Low-pressure 02 inlet a with (CPC) PMC series High-pressure 02 inlet 02 connector, NIST/DISS optional, supply gas pressure is 2.8-6bar Dust filter Filters dustin the Air supply HEPA filter Filters bacteria and viruses in the Air supply Pressure sensor ‘Monitors vacuum at the Air inlet Cuts off the connection between the low-pressure 2 limb of the pneumatic system vi Self-closing cutoff valve | and the outside environment when the ventilator does not connect with the lowspressure 02. = ie Filters foreign substance in the hiah-pressure 02 supply Reduces and stabilizes the pressure of REG Regulator 3 high-pressure 02 supply to 2.020. 1bar High-pressure 02 proportional valve, output PSOL Proportional solenoid valve igh-pr Le BS peak flow 120 L/min@abar a 02 flow sensor Monitors 02 flowSymbol ‘Name Function and Index Fa Filter screen Stabiizes gos flow sp Noise reduction and Air&O2 | Air&O2 mixed channel, seduces the front-end mixed chamber noise ofthe blower subsystem lowes “Turbo blower Mixes the Air and 02 and improves the pressure of mixed gas tothe preset value Tolower ‘Temperature sensor Monitors the blower temperature spe Noise reduction and Air&O2 | Further mixes the Airand O2 and reduces the mixed chamber rearcend noise ofthe blower subsystem Heat Heat exchanger Heat dissipating device ofthe blower Exchanger Inspirator ee | Inspiratory valve Controls the flow in the inspiratory limb a Flow sensor of the mixed gas _| Monitors the flow of mixed gas os 02 sensor Monitors 02 concentration #5 Filer screen Stabilizes gas flow Prevents gns from flowing in the reverse cv2 Cheek valve ® a direction w satay valve Pressure relief and spontaneous inspiratory channel FT Filter for pressure sensor__| Protects the pressure sensor Tnspiratory pressure zeroing | Performs switchover between insprato sou piratory pr 5 piratory thrcesway valve pressure measurement and zeroing 7 Tnspiratory pressure sensor __| Monitors the pressure in the inspiratory limb Prevents water vapor and bacteria inside the FS Inspiratory filter patient tube from entering te ventilator internal pneumatic circuit fier | Humidifier Heats and humiifies the patients inspired gas WIIWI2 ___| Water trap Collects condensed water inside the tube NCV Nebulizer control valve Controls the on-off ofthe nebulizer limb RI Nebulizer needle valve Restricts the output flow of the nebulizer limb Device which turns nebulized liquid medicine ‘Nebulizer Nebulizer into gaseous colloidal particles Prevents water vapor and bacteria inside the ro Expiratory filter patient tube from entering the expiratory module 3 Expiratory flow sensor Monitors expiratory gas flow FIOFLL Filer Protects pressure zeroing three-way valve Pa Filter Protects upstream limb from being polluted by the exhaled gas so? Pressure zeroing three-way | Expirafory pressure sensor zeroing and valve pressure zeroing in the upstream of expiratory 23‘Symbol ‘Name Function and Index flow sensor diaphragm soLs Pressure zeroing three-way | Pressure zeroing in the downstream of valve expiratory flow sensor diaphragm PQ3 Differential pressure sensor | Expiratory differential pressure sensor PE Expiratory pressure sensor —_| Expiratory pressure sensor RIRB Flushing resistor Restricts flushing flow ; ‘Controls system PEEP or Plimit via voice coil EV Expiratory valve ‘motor cvs Check valve Ensures unidirectional gas flow 2.1.2.2 Symbols. Nebulizer a Gas supply <>- Filter Water trap Humidifier wr Humidifier m ; i On-off valve (two-position Regulator Bp * mf two-way solenoid valve) 02 sensor Pressure sensor Check valve Resistor Nebulizer Flow sensor “LIP ‘Two-position three-way soleuoid valve Proportional solenoid valve Tolower © ‘Temperature sensor Turbo blower Inspiratory valve Prilter ‘Vacuum sensor at the Air Turbine heat exch 242.1.3 Theory of Operation of the Pneumatic Subsystem According to structural composition and function, the pneumatic system of the ventilator can be broken down into 7 parts as shown below. which are gas supply subsystem, turbo blower subsystem, flow control subsystem, safety valve subsystem, nebulizing subsystem, patient ‘tube and expiratory assembly. Pneumatic systenn Insp. assembly Patient tube Exp. assembly z] fz z|l=| JBI] JE Fl le] = z/ Je] ls a] |e g z| 2 % Z z g || 2.1.3.1 Gas Supply Subsystem ‘The schematic diagram of the gas supply subsystem is as shown below: The gas supply subsystem includes three timbs: high-pressure O2, low-pressure O2, and low-pressure Air ‘The room air enters the machine after passing through dust filter F and HEPA filer F2. 02 enters the machine after passing through high-pressure O2 limb or low-pressure ©2 limb. Flow sensor QI is placed at the outlet where low-pressure 02 and high-pressure O2 converge to monitor 02 flow entering the machine.> sor Air ae Low: Pressure iniet << ~N Ae 02 Low-Pressure Inlet >—© cv 02 High-Pressure Inlet F3 REG — SOL ‘The gas supply subsystem is the starting part of the ventilator’s pneumatic circuit. It introduces extemal ©2 and room air into the machine. A dust filter is necessary at the Air inlet as there is dust and foreign substance inside the room air. Meanwhile, to filter the bacteria and viruses inside the room ait, HEPA filter is placed at the Air inlet to ensure the air entering the machine is clean and aseptic. After the machine is used or placed for a period of time, dust or foreign substance may be absorbed on the surfaces of the dust filter at the Air inlet and HEPA filter. When the dust or foreign substance is accumulated to a certain extent, ocelusion ocenrs at the Air inlet, which may cause insufficient air intake of the machine, By placing vacuum sensor Pfilter at the Air inlet, occlusion at the Air inlet can be effectively ‘monitored. If the Air inlet is occluded and the Air supply pressure is too low, vacuum sensor Pfilter gives an alarm reminding the user to replace the HEPA filter. 26‘The following picture shows the position of Air inlet and HEPA filter. ‘The connector of high-pressure O2 inlet is designed to be NIST/DISS as required by the standard to prevent misconnection, The connector of low-pressure 2 inlet is designed to be quick connector which is compatible with (CPC) PMC series and provides pneumatic cut-off funetion to prevent gas error between the high-pressure O2 and low-pressure O2 inside the ventilator. Air passes through the dust filter and HEPA filter to enter the machine, There is no standard requirement for the type of Air connector and itis designed to be non-standard connector. The regulator in the high-pressure 2 limb reduces the supply gas pressure and stabilizes it at 2.0:0.1bar to ensure stable output and good repeatability of solenoid proportional valve PSOL at the rear end.‘The 02 inlet assembly is as shown below. High-pressure 02 connector compatible with NIST/DISS 02 proportional valve Nebulizer switch valve ow-pressuse 02 CPC quick connector ‘02 flow sensor Regulator Nebulizer outlet 282.1.3.2 Nebulizing Subsystem The nebulizing control subsystem controls the on-off of nebulized gas flow via NCYV, so as to realize control of nebulizer by nebnlized gas flow (nebulizer needs to be configured separately and is independent of the ventilator main unit). When applying the nebulizer function, note thatthe nebulizing subsystem is enabled only when the system is connected With high-pressure 2 supply. Check if the machine is already connected with high-pressure 02 supply before using this finetion. ‘The diagram of the nebulizing control subsystem is as shown below: OL = R1 NCV NCV is a solenoid two-way valve and it has two states: ON and OFF. R1 is a nebulizer needle valve. It adjusts nebulized gas flow by adjusting the position of the needle valve. When NCV is connected, 02 © needle valve in advance, there is continuous flow of 6-9 L/min at its rear end, Such flow 2.0-6.0baris at its front end. By adjusting the position of the flows into the nebulizer via the nebulizing nozzle, takes away medicine and finally flows into the patient. The extemal structure and size of the nebulizing nozzle comply with BS EN 13544-2_2002 standard, Nebulizing nozzle2.1.3.3 Turbo Blower Subsystem ‘The schematic diagram of the turbo blower subsystem is as shown below, Thlower Pxnanet: if ‘sot soz = ao oS S The turbo blower subsystem mixes Air and 02 and delivers the mixed gas to the lower level assembly. The turbo blower subsystem is composed of blower, heat exchanger. oxygen ‘mixture outlet box assembly, HEPA filter, negative pressure sensor, labyrinth chamber assembly, additional temperature sensor, shock-absorbent material, and silencing sponge, The heat exchanger connects with the blower to conduct the heat produced by the blower outside, Meanwhile, the mixed gas which flows through the blower carries away some heat produced by the turbo blower subsystem. The temperature of the blower affects the service life directly. Therefore, the working temperature of the blower is monitored by the additional temperature sensor (Tblower). If the temperature exceeds the standard, the cooling fan is speeded up to increase the heat-sinking capability of the blower. Negative pressure sensor is used for monitoring the actual negative pressure atthe inlet of the ‘turbine. Ifthe negative pressure exceeds 8kPa, the alarm message [Techmical Error 06] is, displayed on the screen, And then the HEPA filter must be replaced.‘The structural components of the turbo blower subsystem are as shown below. Turbine heat exchanger Mixed 02 outlet box HEPA filter 2.1.3.4 Flow Control Subsystem The chief component of the flow control subsystem is low-pressure large-diameter inspiratory valve. It controls the opening and closing of the valve port via voice coil motor and provides the required pressure and flow for the system. The large-diameter inspiratory valve assembly also provides gas supply for monitoring O2 concentration. The schematic diagram of the flow control subsystem is as shown below.‘The component structure of the flow control subsystem is as shown below Inspiratory valve shell Encapsulated filter screen Voice coil motor 2.1.3.5 Safety Valve Subsystem ‘The safety valve module is located in the downstream of the inspiratory flow sensor. As the inspiratory channel of the system, it is connected with the external breathing tubes or other ‘medical accessories. This module has two functions. One is active pressure relief to prevent the pressure of the pneumatic system from exceeding the preset pressure, The relief pressure can be preset as required by the operator: The relief mechanism is contvolled by software. The other is to provide channel for patient's spontaneous breathing when the system is powered off or standby, to prevent patient apnea. ‘The safety valve module closes or opens the safety valve by controlling the power-on/-off of the electromagnet. ‘The schematic diagram of the safety valve subsystem is as shown below svq- Ti }w FED v Atmosphere‘The corresponding component structure is as shown below. Safety valve base assembly Detachable part of the safety valve Safety valve plug check valve O a diaphragm " Safety valve dust-proof pad Safety Valve diaphragm Safety valve knob The module has fixed part and detachable part. The fixed part includes electromagnet, safety valve base, and floating mechanism. This part is fixed to the machine bracket via screws to support the overall safety valve assembly. The detachable part includes safety valve diaphragm, safety valve main body, check valve diaphragm, safety valve plug, and safety valve knob, This part provides controlled breath and spontaneous breathing channel for the patient, It can be detached without tools by the client for cleaning and disinfection, The external output port of the safery valve subsystem is the outlet part of the gas reservoir. This port complies with coaxial 22mm conical connector specified by ISO 5356-2: 1987, 213‘The gas flow of the safety valve includes the following cases: 1. When the ventilator ventilates normally, the electromagnet is powered on and seals the valve port. 02 enter the patient via safety valve channel. The gas flow is as shown below 2. When the airway pressure is too high, the electromagnet is powered off and opens the pressure relief channel actively to ensure patient safety. The gas flow is as shown below ‘When the airway pressure retums to normal, the electromagnet is powered on. Gas flow retams to that described in case 13. When the patient breathes spontaneously, the electromagnet is powered off and opens the pressure relief channel. The patient obtains air from the atmosphere. The gas flow is as shown below 4. When the machine is powered off inadvertently, the electromagnet is powered off and ‘opens the pressure relief channel to support patient spontaneous breathing. Refer to case 3 for gas flow. 2.1.3.6 Expiration Assembly The expiration module implements pressure control, pressure monitoring, and flow ‘monitoring during the patient expiratory phase. It differs from the inspiration module in that the gas that passes through it is the patient’s exhaled gas. This results in the need to clean and disinfect the components of the expiration module before reuse. The di below. am is as shown sowz F10 Atmosphere <——O‘The expiratory valve (EV) is an electronically controlled valve. The expiratory valve closing pressure is controlled by the voice coil motor. When the control current the system gives to the voice coil motor is zero. the expiratory valve fully opens. When the system gives the voice coil motor certain control current, the voice coil motor seals the diaphragm to the valve port with certain pushing force. The patient's exhaled gas must overcome the valve port sealing force of the gas inside the expiratory valve cavity in order to pass the valve port. This dynamic process finally 2 comresponds to the control current of the voice coil motor), jarantees that the airway pressure is a setting value (this value During the inspiratory phase, the system gives the voice coil motor relatively large control current to seal the valve. The corresponding valve closing pressure differs with the parameters set under vent mode (Plimit in V-A/C mode, Pinsp*PEEP in P-A/C mode, Psupp+PEEP in PSV mode). Gas enters the patient fitst. Ifthe ainway pressure is greater than the valve closing pressure during the inspiratory phase, the expiratory valve diaphragm opens to relieve pressure to ensure patient safety During the expiratory phase, the system gives the voice coil motor zero or relatively small control current, which corresponds to expiratory valve fully open or forming certain valve closing pressure, When the expiratory valve fully opens, it is equivalent to the case that the patient's exhaled gas is directly vented to the atmosphere (Same to expiration by a nonmal person), If the expiratory valve has certain valve closing pressure, it is equivalent to the case that the patient's exhaled gas is always kept above positive pressure; namely, the patient's expiratory pressure is the set PEEP value. ‘The expiratory flow sensor (Q3) is based on the principle of differential pressure. A diaphragm-type sensor (metallic diaphragm flow sensor) is use, which is characterized by high sensitivity. The expiration module uses metallic diaphragm flow sensor to support 134°C autoclaving. The diaphragm will get distorted after ong term of use. Therefore, it needs to be calibrated periodically to maintain measurement accuracy. ‘When the gas flows through Q3, a pressure difference is produced on both sides of the Q3 diaphragm, Flow information is acquired through processing this pressure difference after it is collected by differential pressure sensor PQ3. SOL2 and SOL3 are corresponding zeroing three-way valve. Pressure sensor PE is the sensor measuring the pressure in the expiratory limb, It uses front-end sampling line of Q3 to collect pressure signals In addition, there are two limbs passing through R2 and R3. They produce small flushing gas flow in the pressure sampling line to prevent water vapor from condensing in the pressure sampling line and affecting the accuracy of pressure measurement 216‘The component structure of expiration module is as shown below. Disinfectable expiratory valve assembly Sampling seat assembly Voice coil motor Patient gas outlet Expiratory valve seat Expiratory check Expiratory check valve closed valveopen 2.1.3.7 Patient Tube Patient tube is the peripheral pneumatic circuit of the ventilator, independent of the ventilation main unit, It can be configured as needed. Patient tube connects the ventilator with the patient and humidifies the patient’s inhaled gas, Its diagram is as shown below.=> co >< Patient Nebulizer I 4 a ‘There are disposable and reusable patient tubes. Generally, disposable tubes integrate tube, water trap, and ¥ piece, and are made of PVC material. They are of low cost and are discarded after use. Reusable tubes. typically, are made of silicone which can be autoclaved for many times. The water trap aud Y piece can also be autoclaved. Despite the high cost, reusable tubes reduce clinical cost since they cau be used for many times. Filters are placed at the inspiration port and expiration port of the ventilator. The filtering accuracy is Sum. The filters can effectively prevent bacteria inside the patient tube from entering the ventilator’s pneumatic cirenit ‘The humidifier is placed in the inspiratory tube. After passing through the humidifier, the ‘mixed dry gas the ventilator oumputs become warm saturated gas and then enter the patient’s respiratory tract, avoiding bring discomfort and complication to the patient The nebulizer is connected with the nebulizing nozzle on the front panel of the machine. It tums nebulized liquid medicine into gaseous colloidal particles. During the patient’s inspiration, the medicine is delivered to the patient's respiratory tract and hings together with the nebutize sto treat the patient2.2 Electrical Circuit 2.2.1 Overview of the Hardware Boards ‘The block diagram of SV300/350 hardware system is as shown below. The connection lines in the diagram indicate the connection between hardware boards and that between modules. 219‘The SV300/350 hardware system is divided into the following modules: power module, main control& VPM module, monitoring module, display module, gas parameter module ete 1, Power module: includes AC input, cooling fan, AC-DC board, battery, DC-DC board, battery adapter board; provides power supply for the whole ventilator system. 2, Main contiol&VPM module: includes main control core board, peripheral drive interface ete; fulfills man-machine interaction of the ventilator, data interaction with ‘other modules and subsystems; extends USB and network interfaces. 3. Monitoring module: includes VCM module, inspiration module, expiration module, ‘vactnim sensor board, sensor adapter board ete.; fulfills pressure and flow monitoring, valve control, 02 concentration collection, data interaction with the main control board. 4. Display module: includes LCD screen, touchscreen, alam light board, encoder board, button control ete. 5. Gas parameter module: includes sidestream CO2 module and mainstream CO2 module; choose one from them2.2.2 Electrical Circuit Diagram Bésoo/™2.2.3 Power Supply System 2.2.3.1 Output of the Power Supply System (aee-ynan (actfivada, (asouas asowas: pang onde ne AVF ff UY (pavog s>ydepe S9H0H ¢ Az sey Buyoo.y ARPS pavog doy irPeon: system power-on/off button signal for SV300/350 ventilator, Acon: powver-off signal provided by the main control board; high level for not allowing to power off and low level for allowing to power off 2.2.3.2 Distribution of Power Supplies in the System ‘Power supplies for hardware boards and their parts Monitoring module main board 35V; F12V; 24 ‘Main control core board SV ‘Button control board 333V; =5V; +1V Alarm light board BV Encoder board Vv Sensor adapter board “SV; 33V; SV; 105V; 12V Touchscreen 35 Display 333V; +12V Cooling fan +1BV 2 proportional valve #1av Inspiratory/expiratory voice coil motor av ‘Nebulizing valve 35 Turbo blower 35V; 24V. Mainstream CO2 module =v Sidestream CO2 module #1Dv2.2.4 Board Function For board connections, refer to 2.2.2Electrical Circuit Diagram. 2.2.4.1 Boards of the Power Module ‘The power module includes AC-DC board, DC-DC board, and battery adapter board. Their functions are: © AC-DC board : transforms the external AC input power into DC power (nominal value is 18,88V ) to be used by the DC-DC board. B® DC-DC board : Controlled by the power-ooff circuit, transforms the DC power ‘outputted by AC-DC, extemal DC input, or intelligent battery power inte DC power ‘which the system requires to produce SV, 12V, 24V ete, and performs charging ‘management of the intelligent battery ™ Battery adapter board ; transfer battery signals, AC-DC board: AC input AC-DC outputAC-DC board transforms external AC into intemal DC. TB1 connector is AC input connector. It's defined as follows: Pin No. | Signal name Signal description Remark L L AC input 1 AC signal 2 NC No intemal connection 3 N AC input 2 AC signal TB2 connector of AC-DC board is its DC output connector. It is defined as follows: Pin No. | Signal name. Signal description Remark 1 Ww Positive terminal of AC-DC output 2 +W Positive terminal of AC-DC output 3 Ww Positive terminal of AC-DC output / 4 WW Positive temuinal of AC-DC output 5 GND Ground 6 GND Ground 7 GND Ground 8 GND ‘Ground i DC-DC board: bc - 06 boars External DC AG Deboard D2 DCboard DE- DC powior supply ‘input input pot $1999! POF output port a Soral port Debugging port3 connector of DC-DC board is connector with AC-DC. It is defined as follows: 1 AC_DC_IN 2 AC_DC_IN Input signal AC-DC outputs to | Rated current is 8.8, 3 AC_DC_IN De-be 4 AC_DC_IN 3 GND Ground 7 6 GND Ground 7 7 GND Ground 7 8 GND. Ground 1 12 connector of DC-DC board is DC input connector. It is defined as follows: 1 DCAN+ Positive terminal of extemal DC | / 2 DOI= input signal 7 3 DCAN- Negative terminal of extemal — | / 4 DCAN- DC input signal 7 J11 connector of DC-DC board is the connector with battery adapter board. It is defined as follows: 1 GND Ground 1 > BATT Positive terminal of battery 1 [7 input signal GND Ground 7 4 GND Ground 7 Positive terminal of battery 1 [7 5 BATI oy input signal 6 GND Ground 7 7 BATI input signal GND Ground 7 GND Ground 1 10 GND Ground 7 Positive terminal of battery 1 [7 u BATI input signal 2 GND Ground 7 2:263 GND Ground / Positive terminal of battery 1 [7 4 BATI input signal 15 BATI_BC Ineplace signal of battery 1 7 16 SMBC1 12C clock signal of battery 1 [7 In-place clock signal of batter v supcz Ineplace lock sent oF baery/ 18 SMBDI 12C data signal of battery 1 i 19 ‘SMBD2 12C data signal of battery 2 i 20 BAT? BC In-place signal of battery 2 i 21 GND Ground 7 2 BATT Positive terminal of battery 1 |/ input signal 23 GND Ground 7 24 GND Ground i Positive terminal of battery 1 [7 os atl ‘sitive tenninal of battery input signal 26 GND Ground 7 - BATT Positive terminal of battery 1 [7 input signal 28 GND Ground / 29 GND Ground 7 30 GND Ground 31 BATT Positive terminal of battery 1 [7 input signal 32 GND Ground 7 33 GND Ground i Positive terminal of battery 1 [7 a4 BATI input signal 113 connector of DC-DC board is the connector with monitoring module main board. It is defined as follows: 1 2AVA 24V power supply of turbo blower 2 2AVA 24V power supply of turbo blower 12V power supply of monitoring [7 3 12vA ‘module main board 1 vA 'V power supply of VOM of 7 ‘monitoring module main boardPin No. | Signal name Signal description Remark sve SV power supply of GUI of ‘monitoring module main board 6 GND) Ground 7 Ground 8 Ground 9 Ground 10 Ground J connector of DC-DC board is the connector with monitoring module main board. It is, defined as follows: Pin No. | Signal name Signal description Remark 1 ‘VBUS Power supply of buzzer 2 GND) Ground BELL_CTRL Control pin of buzzer 1 AC LED Control signal of AC indicator ~ light BAT LED Control signal of battery ~ indicator light Serial port signal of power 6 TxD board transmitting to main control board 7 KEY_ONOFF Power-onoff control signal 8 GND. Ground ‘Control power signal of main 9 POWER_EN - control board Serial port signal of power 10 RXD board receiving fom main control board in GND) Ground 2 101 Backup 13. GND) Ground 4 GND) GroundBattery adapter board: Battery adapter board sod anda Aone sndyno Aq ‘TL connector of battery adapter board is the connector with battery. It is defined as follows: 1 GND Ground f 2 GND Ground i 3 TEM ‘Battery temperature detection signal | 7 4 PRT_BC Battery in-place signal 3 ‘SMBC (Clock signal of battery 12C interface 6 ‘SMBD Data signal of battery 12C interface | 7 7 raat Positive terminal of battery input [7 signal 2 7 Positive terminal of battery input | / signal 9 GND Ground I lo GND Ground L 229‘12 connector of battery adapter board is the connector with DC-DC board. It is defined as, follows Pin No._| Signal name Signal description Remark 1 GND. Ground Positive terminal of battery input 2 BAT+ signal 3 GND) Ground Positive terminal of battery input 4 BAT+ : 5 GND) Ground Positive terminal of battery input 6 BAT+ ° signal 7 GND) Ground Positive terminal of battery input 8 BAT+ ° jgnal 9 GND) Ground Positive terminal of battery input 10 BAT> jgnal in GND Ground Positive terminal of battery input 2 BAT> signal B TEM Battery temperature signal 4 ‘SMBC Clock signal of battery 12C interface 15 PRT_BC Battery in-place signal 16 SMBD Data signal of battery 12C interface 2.2.4.2 Main Control Core Board Boards of the main control module include main control core board and peripheral interface cireuit (on the monitoring module main board). Itis the controle: of the ventilator and implements man-machine interface (display screen, external key-in), control command transfer, alarm, ventilator protection function, CO2 parameter module, and peripheral interface cireuit‘Main contol core board: implements the minimum core system of the main control module: Jeads out the pins of the mininmm system to be connected to the monitoring main board. EV20 main control core board debuaaina 2.2.4.3 Monitoring Module ‘The monitoring module includes the following boards: SV300/350 monitoring module main board, $V300/350 sensor adapter board, and $V300/350 vacuum sensor board, $V300/350 monitoring module main board: The monitoring module main board fulfils the SV300/350 core board and ventilator parameter functions, Itinchides DSP control module, inspiration module, expiration module, and main control module peripheral interface circuit. It implements the followit Control all valves and collect AD of analog quantity. Drive and control the turbo blower. Monitor turbine negative pressure and temperature. functions: Monitor pressure and flow signal input, transforms analog quantity into digital quantity Perform UART communication with the main control board. Implement main control board peripheral interface cireuit, such as wired network, wireless network, USB, VGA, display interface eteEV20 monitoring module main board ‘Turbine flue indicator igtD1_—_-YCM alot indicaoe ight D4 Turbine consector_ [Nurse call RS228C, vos —— Senor comet ead Paramcter nodule Sensor ad rerbond |p aup(S702)| Display comecor Buon bord connector Exp. Failwe indicate ight Ds Wieless wifi ‘The following table lists the indicator lights. Item Description Turbine failure indicator light DI Litt a failure occurs to the turbo blower or drive circuit is faulty. Check if the cable for tusbine connector is properly connected. If not, the turbo blower or monitoring module main board itself is faulty. No erate normally. Tnsp. failure indicator light D2 Lit to see if the failure disappears. Ifthe monitoring module main board is damaged, replace the monitoring module main board. If the power board is faulty, enter the AD channel to see if the voltage value which the AD value samples has an error (if'an not lit: ifthe inspiration module has software failure, restart error occurs, the value is displayed in red). Flashing: operate normally ‘Exp. failure indicator light D3 Liténot lit: if the expiration module has software failure, restart to see ifthe failure disappears. Ifthe monitoring module main board is damaged, replace the monitoring module main board. If the power board is faulty, enter the AD channel to see ifthe voltage value which the AD value samples has an error (if'an error occurs, the value is displayed in red). Flashing: operate normally.Item Description VCM failure indictor light D4 | Litinot lit: ifthe VCM module has software failure, restart to see if the failure disappears. If the monitoring module main board is damaged, replace the monitoring module main board. Ifthe power board is faulty, enter the AD channel to see if the voltage value which the AD value samples has an error Flashing: operate normally. 4122 connector of monitoring module main board power supply connector is the connector with DC-DC board. It is defined as follows: VBL 24V power supply of tubo blower —_[/ 2 VBL 24V power supply ofturbo blower [7 12V power supply of monitoring [7 3 ver sodule main board SV power supply of VOM of 7 + vec’ monitoring module main board SV power supply of GUT of s veca 1 tonitoring module main board 6 GND Ground 7 7 GD Ground 7 8 ‘GND Ground 7 9 GND Ground 7 10 GND Ground 7 338 connector of monitoring module main board is the connector with DC-DC board. It is defined as follows: 1 BUS Power supply of buzzer 1 2 GND Ground 7 3 ‘BELL_CTRL Control pin of buzzer 7 4 ACIED Control signal of AC indicator light | 7 , BAT LED Control signal of battery indicator | 7 light Serial port signal of main 7 6 UARTA_338X_RXD control board receiving from power board PCON Power-on/off control signal i GND Ground i 2-33Control power signal of main ° POWEREN control board Serial port signal of main 7 10 UART4_335X_TXD control board transmitting to power board ul GND Ground i 12 BK Backup i B Blank Blank 7 4 Blank Blank 7 19 is VGA connector of external display socket. It is defined as follows: RO R signal of external display i Go G signal of external display 7 BO B signal of extemal display 7 NC ‘No intemal connection i GND Ground i GND. Ground i GND. Ground 7 GND Ground 7 NC ‘No intemal connection i GND Ground di NC ‘No intemal connection 7 NC ‘No intemal connection 7 “Horizontal synchronization signal FED Hs of extemal display : ‘Vertical synchronization signal of eps extemal display - ! NC ‘No intemal connection 7 111 is extemal USB connector. It is defined as follows: 1 ‘USBO_VBUS USBO power supply sv 2 ‘USBO_DM, USBO signal cable 7 3 USB0_DP USBO signal cable 7 4 GND Ground 7 234510 is external nurse call connector. It is defined as follows: ‘Nurse call signal GND Ground i GND. Ground t GND. Ground 1 Ground J8 is network connector: It is defined as follows: “Main control network transmitting 337 is nebulizing valve connector. It is defined as follows: VCCBL Nebulizing valve power supply, 5V 1 TX+ 1 signal “Main control network transmitting 2 TX. ely signal- “Main control network receiving 3 RX , signal 4 GND Ground i 3 GND Ground 7 6 RY ‘Main contiolnetwork seceiving | | signal- GND. Ground 7 GND Ground 7 NCV- Nebulizing valve control terminal SW_02+ Gas supply pressure switch signal, reserved QD 1129 is the connector between monitoring module main board and vacuum sensor board. It is defined as follows: Ground ‘Vacuum sensor power supply. 3.3V Ground 2-35AMBIENT. SDA_INSP ‘Data line for vacuum sensor 2C connector GND Ground AMBIENT. SCL_INSP Clock line for vacuum sensor 12 connector 21 is CO2 module connector. It is defined as follows: ‘Communicate with the ‘13 is the speaker connector. It is defined as follows: EX_SV_TXA Extension serial port transmitting | sidestream CO2 module ‘Communicate with the RS232_RXD Extension serial port receiving ‘mainstream CO2 module GND Ground 7 GND Ground 7 ‘Communicate with the EX SV_RXA Extension serial port receiving sidestream CO2 module ‘Communicate with the RS232_TXD Extension serial port transmitting _ | mainstream CO2 module GND Ground 7 Mainstream CO2 module power vecac , supply. SV “Mainstream CO2 module power vecac . j supply, SV - Sidestream CO2 module power PWRI2V 1 supply.12V_ GND Ground i PWRI2V ‘CO2 module power supply, 12V_[7 Vo- Speaker drive signal- Vo= Speaker drive signal ~ 2-36‘10s the connector between monitoring module main board and display. It is defined as, follows: Pin No. | Signal name Signal description ‘Remark 1 GND. Ground / 2 GND) Ground / 3 GND. Ground i 4 GND) Ground i 3 GND) Ground / LVDS DIFFERENTIAL DATA. 6 LVDS_0- ~ LINEO- Display backlight power supply. ; pWRIV splay backlight power supply 12 s Lvs o- LVDS DIFFERENTIAL DATA, - LINEO= Display backlight power supply. 9 PWRI2V PLONE SES IV 10 GND Ground Display backlight power supply. u PWRI2V pny bag PowesssPP 12V b Lvps 1 LVDS DIFFERENTIAL DATA * a LINEI- Display backlight power supply. 1B PwRI2V lay backlight powsr supp, 12V LVDS DIFFERENTIAL DATA 4 LYDS_I+ LINEI+ 15 GND) Ground 16 GND. Ground 7 7 GND. Ground 18 LVDS_CK- Display differential data line- p 19 VLCD Display power supply, 3 3V 20 LVDS_CK+ Display differential data line- 21 VLCD Display power supply, 3.3V 2 GND) Ground 23 VLCD Display power supply, 3.3V Ei DS a Lvs > LVDS DIFFERENTIAL DATA. LINE2- os wan Backlit brightness adjustment LVDS DIFFERENTIAL DATA 26 LVDs_2+ ~ LINE2+Pin No. | Signal name Signal description Remark 27 GND. Ground 28 GND. Ground 29 SET_6bit/Sbit Display bit color control 30 Lys =. LVDS DIFFERENTIAL DATA. ~ LINE3- 31 BACKLIGHT_EN Display backlight enabled Lvs 3 LVDS DIFFERENTIAL DATA, ~ LINES~ 33 NC No intemal connection 34 GND) Ground 35 No internal connection 36 round 37 ‘No intemal connection 38 ‘No intemal connection 39 ‘No intemal connection 40 No internal connection ‘17 is the connector between monitoring module main board and button control board. It is defined as follows: Pin No. | Signal name Signal description Remark 1 PWRI2V Burton board power supply, 12V 2 VCCA Button board power supply, SV 3 GND) Ground 4 VDDA Button board power supply. 3.3V 3 GND) Ground 6 Button board communication serial port, main control transmitting 7 Ground s Button board communication serial port, main control receiving 9 AC LED AC indicator light 10 BAT LED Battery indicator light 1 PCON Power-on signal 12 GND. Ground){130 is the 02 proportional valve connector. It is defined as follows: 02_Valve> Positive terminal of 02 proportional valve 02_Nalve- ‘Negative terminal of 02 proportional valve Lis the turbo blower connector. It is defined as follows: 1 HD Hall position signal H2 ! 2 HI Hall position signal HI 1 3 vecs. Hall sensor power supply t 4 MOTOR_A Turbo blower drive signal A 5 NTCL ‘Thenmistor 6 H3 Hall position signal H3 i 7 GND Ground f 8 MOTOR_C Turbo blower drive signal 1 9 MOTOR B Turbo blower drive signal B 1 10 NTC21 Ground i {12 is the connector for turbo blower external temperature sensor. It is defined as follows: One terminal of temperature sensor No positive and 2 NTC> The other terminal of temperature sensor 1131 is the connector for proportional valve. Tt is defined as follows: 1 Insp_Valve+ Positive terminal of inspiration proportional valve negative terminals are differentiated. 2 Insp_Valve+ Positive terminal of inspiration proportional valve 1 3 7 t Suspended 4 Insp_Valve- ‘Negative terminal of inspiration proportional valve 1 2-39‘Negative terminal of inspiration proportional valve f Ground Fix pad pin Ground 1132 is the connector for expiratory valve. It is defined as follows: Positive terminal of expiration Fix pad pin 1 Exp_Valve+ ’ proportional valve > ap Vale= Positive terminal ofexpiration | proportional valve 3 NC i Suspended ‘Negative terminal of expirat 1 rap Vahe- egative terminal expiration | proportional valve Fap Vale ‘Negative tenminal of expiration — | proportional valve 6 GND Ground 7 7 GND Ground 7 4335 is the connector between monitoring module main board! and sensor adapter board. It is defined as follows: 1 Safety. Negative terminal of safety valve | / 2 Safety_Valve~ Negative terminal of safety valve [7 3 ‘V_Safety_Valve Safety valve power voltage 4 V_Safety_Valve Safety valve power voltage 5 Way Purge 1 Exp. | “otto signal oF expiratory ) purging 3-way valve | Control signal of expirator 6 3Way_Purge 2 Exp- oe , purging 3-way valve 2 Control signal of expiratory zeroin; 7 3Way_Ze1o_1_Exp- ene or espuarony zone | Seaway valve 1 Control signal of expiratory zeroin: 8 3Way_Zero_2_Exp- nl) Seaway valve 2 9 VCCBL Power supply Sv Control signal of inspiran 10 3Way_Zero_Insp- eee ke / Zeroing 3-way valve ul VCCBL Power supply Sv 2-40Pin No. | Signal name Signal description Remark 2 GND. Ground 13 Blank 7 14 Blank 7 15 (02_TSL_SCL Clock signal of 02 TSI sensor 16 GND Ground pi 1" INSP-TSI SCL Clock signal of mixed gas TSI 18 (02_TSI_SDA Data signal of 02 TSI sensor 19 GND) Ground i Data signal of mixed gas TSI 20 INSP_TSL_SDA sons, 21 DDB Power supply 33V z GND) Ground 23 VCCBL Power supply sv 24 AVSS Power supply sv 25 GND Ground 26 AVCC Power supply sv 27 ve Power supply 105V, 28 GND Ground 29 EXP_PIN Expiratory pressure p 30 EXP_FIN Expiratory flow 31 GND Ground 2 TEMPO” 181 Temperature signal of 02 TST | sensor 33 FLOW_02_TSI Flow signal of O2 TSI sensor pi 34 GND. Ground 35 FiO2 Inspired 02 concentration p 36 INSP_PIN Tnspiratory pressure 37 GND) Ground 38 GND. Ground Flow signal of mixed gas TSI 39 FLOW_INSP_TSI . s sensor ‘Temperature signal of mixed gas 40 TEMP_INSP_TST _— TSI sensor GND’ Ground Fix pad pin GND) Ground Fix pad pin$V300/350 sensor adapter board: ‘The adapter board implements the following functions: ‘Monitor inspiratory pressure and expiratory pressure, output amplified signals, Monitor expiratory flow and output amplified signals ‘Monitor 02 concentration and output amplified signals, Transfer 02 flow and inspiratory flow signals. Transfer to 3-way valve, Transfer to safety valve control signal, EV20 sensor adapter board Monitoring module xp, Nowipressure ain board connector erin Exp. low sensor Exp. pressure sensor Insp. zeraing. Insp. Pressure OP Mow sehsor Safely valve LOW PRESUE N .OD sensor 43 is the connector between sensor adapter board and monitoring module main board. It is defined as follows: Pin No. | Signal name Signal description Remark 1 TEMP_INSP_TST ‘Temperature signal of mixed gas TSI 2 FLOW_INSP_TSI Flow signal of mixed gas TSI sensor_|/ 3 GND Ground 4 @D Ground 5 INSP_PIN Tnspiratory presse 6 Fi02 02 concentration. 7 GND Ground / 8 FLOW_02_TST Flow signal of 02 TST sensor 9 TEMP_O2_TST ‘Temperature signal of 02 TST sensor 10 GND Ground u EXP_FIN Expiratory flow 2 EXP_PIN Expiratory pressure 7 1B aD Ground 4 vc Power supply 10.5V 15 AVEC Power supply sv 16 GND Ground 242Pin No. | Signal name Signal description Remark 7 AVSS Power supply SV 18, VCCBL Power supply sv 19 GND. Ground 20 VDDB Power supply 33 21 INSP_TSI_SDA| Data signal of mixed gas TSI sensor 2 GND. Ground 23 (02_TSL_SDA Data signal of 02 TSI sensor 24 INSP_TSI_SCL. Clock signal of mixed gas TST sensor 25 GND Ground 26 O2_TSL_SCL Clock signal of 02 TSI sensor 27 Blank 28 Blank 29 GND Ground 30 VCCBL Power supply sv I ‘Way Zero tn ‘Control signal of inspiratory zeroing Bway valve 32 VCCBL Power supply SV - “Way Zero? Exp Control signal of expiratory zeroing | 3-way valve 2 a Way Zero 1 Exp ‘Control signal of expiratory zeroing Sway valve 1 4s sWay Purse 2 Exp | Contol signal of expiratory purging 3-way valve 2 ; Control signal of expiratory purging 36 sWay Page LE | ake] 37 V_Safety Valve Safety valve power voltage Dy 38 V_Safety_Valve Safety valve power voltage 39 Safety_Valve~ ‘Negative terminal of safety valve 40 Safety_Valve~ Negative terminal of safety valve 4 GND Ground Fix pad pin 2 GND) Ground Fix pad pin {IL is connector for 02 concentration sensor. It is defined as follows Pin No. | Signal name Signal description Remark Positive terminal of O2 1 02_SENSOR= concentration sensor 3 02 SENSOR. ‘Negative tenninal of O2 _ concentration sensor 24314s the connector for 02 flow sensor. It is defined as follows: 1 02_FLOW_TSI Flow signal of 02 TSI sensor | / 3 2 TEMP_TSI Temperature signal of 02 TST |, sensor 3 GND Ground 7 4 02 SCL_BC TSI Clock signal of 02 TST sensor [7 3 02_SDA_2C_TSI Data signal of 02 TSIsensor_—_ [7 6 VCCBL Power supply 7 7 GND Ground 7 8 DDB EEPROM power supply, 1 JS is the connector for mixed gas flow sensor. It is defined as follows: Flow signal of mixed gas TST 1 INSP_FLOW_TSI sensor > INSP_TEMP_TS1 Temperature signal of mixed — |, as TSI sensor 3 GND Ground 7 4 INSP SCL_120 TSI Clock signal of mixed gas TSI [7 sensor , INSP-SDA12c Tg) | Date signal ofmixed gas TSI] 7 sensor VCCBL Power supply 7 GND Ground 7 VDDB EEPROM power supply 12 is the connector for safety valve. It is defined as follows: 1 ‘V_SAFE_VALVE Positive temninal of safety valve [/ ‘Neantive terminal of safe 2 SAFE_VALVE- a ey valve 244$V300/350 vacuum sensor board: ‘This board measures the negative pressure at the turbo blower. Ifthe turbine inlet is occluded, relevant alam is given, Ev20sensor adapter board ‘Lis the connector for vacuum sensor adapter board. It is defined as follows: ‘Vacuum sensor power supply, 1 Ve ae 1 ai QD Ground 7 Data line of vacuum sensor 2C 3 AMBIENT_SDA_INSP ! connector 4 GND Ground 1 5 AMBIENT SCL_unsp | “loelineof vacuum sensor] 12C connector 2.2.4.4 Display Module Boards of the display part are responsible for man-machine interaction. They include button ‘control main board, alarm light board, and encoder board. Button control main board 1, Process button input and encoder input 2. Drive alarm light and indicator light (battery and AC), 3. Perform UART communication with the main control beard. 4. Process touchscreen input. 5 Provide buttons for power-on/off and silence. 245= Alam light board Support alarm display in red and yellow Encoder board 1, Select and confirm touch buttons on the SV300/350 ventilator display. $V300/350 button control main board: Power-owof? button ‘Alarm silence button Powel-on off backlight AC ind BAT indicator lights Alam silence indicator tisht Encoder Alaa light Monitoring mole comestor connector ain board connector “Tovclucreen input port Button control board {33 is the connector between button control board and monitoring module main board. It is, defined as follows: Provide power supply for 1 veP 12V power supply alam light and alam silence indicator light Provide power supply for 2 vec SV power supply touchscreen control IC and encoder part 3 GND Ground i 4 pp power spy Provide power supply for button control CPU part GND Ground i Button control serial port 6 TXD_MAIN TILALVTTL receiving 7 GND Ground / Button control serial port . 8 RXD_MAIN TTLALVTTL = transmitting 9 LED_AC Signal of AC indicator light | / 10 LED_BAT Signal of battery indicator ight [/ iL PCON Signal of powerowoff button [7 2-46- GND Ground 7 J is the connector between button control board and alarma light board. It is defined as follows: ‘LED_RED Control signal of red alarm light Control signal of yellow alan [7 light 2 LED_YELLOW ‘Alarm light 12V power supply 7 3 ‘VPP 12V power supply Ground GND Lis the connector between button control board and encoder board. It is defined as follows: 1 GND Ground 1 2 ES. Encoder pressdown Z 3 EB Encoder output B Z 4 EA Encoder output A 7 Encod 3 vee S.0V power supply 5 OC pow supply 4 is the connector between button control board and encoder board. It is defined as follows x Touchscreen RT signal ‘XR_XLIN Touchscreen RL signal ADSIN Touchscreen SG signal Touchscreen LT signal Touchscreen LL signal $V300/350 alarm light board: Connector with button control board CEetreer Alarm light board 247‘Lis the connector between alarm light board and bution control board. It is defined as follows LED_RED Control signal of red alarm light | / 2 LED_YELLOW, Control signal of red alarm light | 7 5 vp 12V power supply sen light 12V power suppl 2483 Checkout and Test ZXWARNING © After servicing the equipment or replacing its components, compelete all the tests in this section. © Before doing the tests in this section, completely reassemble the equipment and refer to § Maintenance and Calibration to do necessary calibrations. 3.1 System Inspection NOTE © Make sure that the breathing system is correctly connected and not damaged. Make sure that: ‘The equipment is not damaged. All components are correctly attached M 1 3. The breathing system (including the inspiratory safety valve, expiration valve, humidifier, and nebulizer ete.) is correctly connected and the breathing tubes are not damaged ‘The gas supplies are comectly connected and the pressures are correct. Cylinder valves are closed on models with eylinder supplies. ‘The casters are not loose and the brake (s) is set and prevents movement. ‘The power cord is correctly connected. The external power indicator and the battery indicator work normally. 8. The ventilator is switched on or off normally. 3.2 Power Failure Alarm Test (External Power and Buzzer) 1. Connect the ventilator to the power supply. Both the power indicator and battery indicator should come on. If the power indicator isnot lt, check the fuse and power board. 2. Depress the power switch to tum on the ventilator. Disconnect the power socket with the system tumed on, The prompt message [Batter {in Use] is displayed in the system alarm message area. Meanwhile. the power indicator is extinguished and the battery indicator is flashing. 4. Reconneet the power supply and the prompt message [Battery in Use] disappears. The power indicator is lit. The battery indicator stops flashing and stays on Remove the battery fiom the ventilator, and disconnect the power socket. The ventilator will shut down and the buzzer buzz for more than 120 seconds. If the buzzer does not respond, replace the monitoring board main board. SI3.3 O2 Pipeline Test Connect the 02 pipeline supply. Connect the test lungs. Depress the system switch to turn om the ventilator Select [New Aduit] in standby mode, _ Set ventilation type to [Non-invasive] and 02% to 40%, Then select [Start Ventilation] to allow the ventilator to enter ventilation status Make sure that the ventilator ventilates normally. Disconnect the 02 pipeline supply. ‘As 02 pressure decreases, the high level alarm [02 Supply Failure] is triggered. 3.4 System Test 1 Enter system check: © Enter system check screen after power-on, Connect 02 supply and block the Y piece as prompted. Then select [Continue] to start system check item by item. Pushthe [Standby] key. Standby screen appears after your confimmation The standby screen displays last system check time and result. Select [System Check] Connect 02 supply and block the Y piece as prompted. Select [Continue] to start system check item by item, System check items include © Blower test: test the rotation speed of the blower @ 02 flow sensor test: test the flow sensor in O2 limb ; Insp. flow sensor test : test the inspiratory valve and flow sensor © Exp. flow sensor test: test the expiratory flow sensor ; © Pressure sensor test: test the pressure sensors at the inspiratory and expiratory ports: © Expiratory valve test © Safety valve test, © Leakage (mL/min) © Compliance (mL/em#i20) : © Circuit resistance (emH20/L/s) © 02 sensor test. System check result can be: Pass: indicates that check of this item is completed and is passed, Fail: indicates that check of this item is not completed and is failed Cancel: indicates that check of this item is not completed: (02 Supply Failure : indicates that O2 supply is insufficient when 02 flow sensor test and O2 sensor test are being carried out; Monitoring Of: indicates that ©2 concentration monitoring fnct switched on when O2 sensor testis being carried out. oe e008 may not be ‘When system check is being performed, the system prompts [Running] on the right side ‘of the current check item. — In this case, if you select [Skip], the system stops check of this item immediately and displays [Caneel]. Check of the next item begins at the same time. Ifyou select [Stop]. the system stops check of the current item and also check of the remaining items, and displays [Cancel]5. When checks of all items are completed, if you select [Retry], the system starts a new round of check. When [Exif] is selected, the system exits check and enters standby sereen 6. Make sure that all the [Syst. Check] items pass the test 3.5 Spontaneous Breathing Test 1, Tum off the ventilator and let the ventilator in OFF state. Wear a mask, and check if the spontaneous breathing is smooth 2, Tum on the ventilator and let the ventilator in Standby state. Wear a mask, and check if the spontaneous breathing is smooth. 3.6 Humidifier Performance Test For detailed performance test information, please refer to the Instructions for Use of the humidifier. Make sure that the humidifier works normally. 3.7 Alarm Tests 3.7.1 Prepare for Alarm Tests Connect test lungs to the Y piece patient connection. Tum on the ventilator. Select [New Adult] in standby mode. Set ventilation type to invasive]. 3. Set the ventilator controls as follows (in standard working state): ‘Ventilator mode: [V-A/C] 02 concentration [02%]: 40% Tidal volume [TV]: 500 ml Inspiration time [Tinsp]: 2s, or Inspiration and expiration ratio [I :E]: 1:2 Frequency [f]: 10 bpm Positive end-expiratory pressure [PEEP]: 3 cmH20 Note: the working mode of the ventilator in this chapter refers to standard working state unless specified otherwise. oooeoe 4. Set the ventilator to exit standby state and enter working state. 5. Make sure of; © Normal display of the ventilator monitored parameter data © Periodical inspiraton and expiration of the test lungs. 3.7.2 Battery in Use Alarm Test Connect the ventilator to AC power and depress the ©/O hardkey. Disconnect the AC power after the system starts up. ‘Verify that the [Battery in Use] alarm is activated and the ventilator is powered by the battery. Re-connect the AC power. 5. Verify that this alarm is automatically reset and the ventilator is AC powered. 333.7.3 Power Failure Alarm Test Connect the AC power and depress the ©/O hardkey to start up the ventilator. Disconnect the AC power after the battery is fully charged. ‘Connect the test lungs to let the ventilator keep normal ventilation, For the veutilator configured with one battery, the ventilation time is approximately 2 hours (for the ventilator configured with two batteries, the ventilation time is approximately 4 hours). When the battery capacity is to be depleted, verify that the [System DOWN. Connect AC.] alam is activated. Re-comect the AC power. Verify that this alarm is automatically reset and the ventilator is AC powered 3.7.4 Paw Too High Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set Paw high alarm limit to current peak: pressure~SemH20, Squeeze the test lungs forcibly in the inspiration phase. ‘Verify that the [Paw Too High] alarm is activated, breathing cycle enters expiration phase, and Paw decreases to PEEP value. 3.7.5 TVe Too High Alarm Test 1 After the ventilator system starts up normally, comnect the ventilator to the test lungs and set to pressure mode to start ventilation. Set TVe high alarm limit to be less than the current TVe to verify that the [TVe Too High] alarm is activated. Set TVe high alarm limit to be greater than the current TVe to verify that this alarm is automatically reset. 3.7.6 TVe Too Low Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set TVe low alarm limit to be areater than the current TVe to verify that the [TVe Too Low] alam is activated Set TVe low alarm limit to be less than the current TVe to verify that this alarm is automatically reset 3.7.7 MV Too High Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set MV high alarm limit to be less than the eurent MV to verify that the [MV Too High] alarm is activated Set MV high alarm limit to be greater than the current MV to verify that this alarm is automatically reset a43.7.8 MV Too Low Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set MV low alarm limit to be greater than the current MV to verify that the [MV Too Low] alarm is activated. Set MV low alarm limit to be less than the curreat MV to verify that this alan is, automatically reset. 3.7.9 PEEP Too Low Alarm Test 1 Remove the expiratory valve diaphragm of the ventilator and install the expiratory valve, After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set PEEP to ScmiH20. Verify that the [PEEP Too Low] alarm is activated Re-instal the expiratory valve diaphragm and install the expiratory valve Repeat steps 2 and 3. Verify that this alarm is automatically reset. 3.7.10 Airway Obstructed Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test innas and set to pressure mode to start ventilation, {ip the inspiration tube with the hands, Make sure the monitoring value of TVi is lower ‘than 10 ml After several breathing cycles, verify that the [Airway Obstructed?] alarm is activated. Loosen the inspiration tube and verify that this alarm is automatically reset. 3.7.11 Apnea Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test lungs to start ventilation. Set apnea alarm time to 15s, Set breathing frequency to sbpm. Verify that the [Apnea] alarm is activated Sct breathing frequency to 10bpm. Verify that this alarm is automatically reset 3.7.12 ftotal Too High Alarm Test 1 After the ventilator system starts up normally, connect the ventilator to the test un: start ventilation. Set total high alarm limit to be less than the current ftotal. Verify that the [ftotal Too High] alarm is activated, Set ftotal high alarm limit to be greater than the current ftotal. Verify that this alarm is automatically reset. to3.7.13 FiO2 Too High Alarm Test 1 Connect the ventilator to low-pressure 02 supply. Select [Setup] —- [Maintain] --[User] enter the required password—[Setting] [Gas Supply] to set [02 Supply Type] to [LPO] ‘Connect the ventilator to the test lungs to start ventilation After ventilation is stable, set FiO2 high alarm limit to be less than the current O2, concentration monitored value. ‘Verity that the [F102 Too High] alarm is activated, Set Fi02 high alarm limit to be greater than the current ©2 concentration monitored value, Verify that this alarm is automatically reset 3.7.14 Fi02 Too Low Alarm Test 1 Connect the ventilator to high-pressure O2 supply. Select [Setup] [Maintain] [User]—enter the required password—[Setting]—[Gas Supply] to set [02 Supply ‘Type to [HPO], Connect the ventilator to the test Inngs to start ventilation After ventilation is stable, turn off high-pressure ©2 supply. ‘Verify that the [F102 Too Low] alarm is activated, Re-connect high-pressure 02 supply. Verify that this alarm is automatically reset. 3.7.15 EtCO2 Too High Alarm Test Connect the CO2 test module, Set CO2 module to working mode, Connect the ventilator to the test ngs to start ventilation. After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to sidestream CO2, At the module sampling port or the airway adapter of mainstream CO2 module, set E1CO2 high alarm limit to be less than the standard gas concentration. ‘Verify that the [EtCO2 Too Hiigh] alarm is activated. Set EtCO2 high alarm limit to be greater than the standard gos concentration. Verify that this alam is automatically reset. 3.7.16 EtCO2 Too Low Alarm Test ‘Connect the ventilator to the test lungs to start ventilation Connect the CO2 test module, Set CO module to working mode, After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to sidestream CO2, At the module sampling port or the airway adapter of mainstream CO2 module, set ECO? low alarm limit to be greater than the standard gas concentration. ‘Verify that the [EtCO2 Too Low] alarm is activated. Set EtCO2 low alarm limit to be less than the standard gas concentration, Verity that this alan is automatically reset. 363.7.17 SpO2 Too High Alarm Test 1 Connect the adult SpO2 sensor to the ventilator SpO2 comector. Set the ventilator patient type to [New Adult]. Select [Setup] [Sensor] ~[SpO2] and set [Monitoring] to [Ou). Measure SpO2 at your finger (supposing you are in healthy state). Set the SpO2 hight alarm limit to 80% when the ventilator is stabilized ‘Verify that the [Sp02 Too High] alarm is activated. Set the Sp02 high alarm limit to 100%. Verify that this alarm is automatically reset. 3.7.18 SpO2 Too Low Alarm Test 1 ‘Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator patient type to (New Adult} Sclect [Setup]-~[Sensor]--[SpO2] and set [Monitoring] to [ON], Measure Sp02 at your finger (supposing you are in healthy state). Set the SpO2 low alarm limit to 98% when the ventilator is stabilized. Hold the wrist of the hand with sensor. Hold and press pulse until the SpO2 reading is less than 98%, Verify that the [SpO2 Too Low] alarm is activated. Stop pressing the pulse and set the SpO2 low alarm limit to 90%. Verify that this alarm is automatically reset. 3.7.19 PR Too High Alarm Test 1 5 Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator patient type to [New Adult] Select [Setup]--[Sensor |+[SpO2} and set [Monitoring] to [ON] Measure SpO2 at your finger (supposing you are in healthy state). Set the PR high alarm limit to 40 L/min when the ventilator is stabilized, ‘Verify that the [PR Too High] alarm is activated Set the PR high alarm limit to 120 L/min, Verify that this alarm is automatically reset, 3.7.20 PR Too Low Alarm Test 1 ‘Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator patient type to [New Adult}. Select [Setup]—~[Sensor]—[SpO2] and set [Monitoring] to (ON), ‘Measure Sp02 at your finger (supposing you are in healthy state). Set the PR low alarm limit to 120 Limin when the ventilator is stabilized, Verity that the [PR Too Low] alarm is activated. Set the PR low alarm limit to 40 L/min. Verify that this alarm is automatically reset.3.8 Function Tests 3.8.1 Checking the Standard Working Mode ‘Tum on the power switch and make sure that the ventilator is in working mode. © Ventilator mode: [V-A/C] © 02 concentration [02%]: 40% © Tidal volume [TV]: 500 ml © Inspiration time [Tinsp]: 2s- or Inspiration and expiration ratio [I sE]s 1:2 @ Frequency [f]: 10 bpm © Positive end-expiratory pressure [PEEP]: 3 cmH20 3.8.2 Checking the Tidal Volume Tum on the ventilator and connect the test hangs. When the tidal volume output becomes stable, observe the tidal volume displayed om the screen, Make sure that the displayed tidal volume monitored value is stable and the monitored value is consistent with the set value 3.8.3 Checking the Trigger Function 1, Set the pressure trigger sensibility to -2 cmH,O. Wear a mask and inspire gently. When ‘the airway pressure is a bit lower than this set value, starts inspiration and the trigger icon flashes in the information bar of the screen. Set the flow trigger sensibility to 2 L/min, Wear a mask and inspire slightly. When the inspiration flow is a bit lower than this set value, starts inspiration and the trigger icon flashes in the information bar of the screen. 3.8.4 Checking Spontaneous Breathing in CPAP/PSV Mode 1, Set the ventilator to CPAP/PSV mode, flow trigger to 2 Litnin, pressure support level to 10 camHizO, ancl other parameters to their default values. 2. Weara mask and inspire slightly. When the trigger sensitivity is reached, make sure that inspiration starts and that the ventilator starts PSV ventilation, 3.8.5 Sidestream CO2 Test and Calibration Leak test: 1, Instandby mode, occlude the gas inlet of the module or watertrap with hand or other object after CO2 warm-up is completed. After occluding the gas inlet of the module or watertrap for a period of time, the sereen displays the alam message [CO2 Sampleline Occluded], indicating that the module hhas no leaks.‘Module calibration: Test tools: © CO2 with concentration of 6£0.05%, cylinder with N2 as balance gas = T-connector = Gastube = Flowmeter 1, Make sure that the sidestream CO2 module has already been warmed up or started 2. Check the airway and leakage. Make sure that there is no leakage in the airway. 3. Select [Setup] [Maintain]—[User]—enter the required password—>[CO2 In Maintenance) {Zero}. 4. Connect as shown below after successful zeroing. Flowmeter Relief valve image cmecsae Ventilator Gas cylinder 5. Tum on and adjust the regulator switch to make the flowmeter indicate flow of 10 to 50 ‘mL/min and Keep such flow. 6. Enter 6% (CO2 concentration value) in the [CO2%] text box in the [CO2 In Maintenance] men. After the actually measured CO2 concentration is stable, select [Calibrate] to calibrate the CO2 module. After successful calibration, the message [CO2 % Calibration Completed!] is displayed. Ifthe calibration fails, the message [Calibration Failure! ‘Try again!] is prompted. In this case, calibrate again. 393.8.6 Mainstream CO2 Test Test tools: © CO2 with concentration of 6£0.05%, cylinder with N2 as balance gas © Cylinder wtih 100% N2 = T-connector B Gas tube = Flowmeter 1. Make sure that the mainstream CO2 module has already been warmed up or started 2. Select [Setup]—[Calibrate]— [Zero]. Select the [Start] button corresponding to CO2 zeroing. The screen displays [CO2 Zeroing] 3. After suecessfil zeroing, put the sensor before the mouth and breathe so that there is a CO2 waveform on the screen. Then put the sensor in the air. Check that the ventilator produces the alarm message [Apnea CO2} 4, Coumect the test system as shown below. Relief valve N2 oflinder H Connector Ventilator Relief valve " 02 gfinder 5, Open the N2 eylinder and CO2 cylinder regulators, Make sure that there is only one cylinder connected with the T-comnector at a time. 6. Adjust the regulator switch to make the flowmeter indicate flow of 2~SL/min and keep such flow. Switch the cylinders connected with the T-comiector ata time interval of 6-10s. Check that the CO2 displayed value is 4542mmHe.3.8.7 SpO2 Test 1 3.8.8 Checking the Special Funct . 1 Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator patient type to [New Adult]. Measure $p02 at your finger (supposing you are in healthy state). Check that the ventilator displays SpO2 Pleth waveform and PR value, And the displayed SpO2 range should be 95-100%. Remove the Sp02 sensor from the finger. Verify that the alarm [SpO2 Sensor Off] is, produced, ns Inspiration Hold Select the [Tools] key —- [Functions] [Insp Hold]. Press and hold the [Insp. Hold] key continuously. Make sure that the ventilator enters inspiration hold phase. The ‘ventilator automatically terminates the inspiration hold function if the [Insp. Hold] key is pressed and held for continuous 30 seconds. Release the [Insp. Hold] key, and make sure the ventilator enters expiration phase. Expiration Hold Sclect the [Tools] key —-[Functions] —[Exp. Hold]. Press and hold the (Exp. Hold] key continuously. Make sure that the ventilator enters expiration hold phase. The ventilator automatically terminates the expiration hold fimetion if the [Exp. Hold] key is pressed and held for contintious 30 seconds Release the [Exp. Hold] key, and make sure the ventilator enters inspiration phase. 02 Enrichment ‘When the ventilator is in working state, select Adult mode and press the [Ozt Suction] button. Make sure that the ventilator starts to deliver 100% 02 Press the [O21 Suction] button again or maintain O2 enrichment fumetion active for 2 minutes. Make sure that the ventilator restores to the working state before O2 enrichment. Suction ress the [01 Suction] button to enter suction function, Make sure that suction enters the first phase: namely, 02 enrichment is active. Disconnect the patient. Make sure that suction enters the second phase; namely, 02 enrichment is not active, The message [The Patient is Disconnected! Reconnect Patient after Suction Completed!) is prompted Re-connect the patient, Make sure that suction enters the third phase; namely, 02 enrichment is active Nebulizer ‘When the ventilator is in working state, press the [Nebulizer] key and set [Nebulizer Time] in the accessed menu. Then select [Ok]. Make sure that the ventilator starts nebulizer function that there is gas output at the nebulizer output port. When the nebulizer time expires or the [Nebulizer] key is pressed again, make sure that ‘the ventilator terminates nebulizer function,= Manual Breath ‘When the ventilator is in working state, select the [Tools] key — [Functions] —> [Manual Breath], Make sure that the ventilator delivers mechanical ventilation immediately. = Sigh 1. When the ventilators in working tte, seec the Dll xe. st [Sigh] 0 [ON 2, Set ventilation parameters to their default values: [Aimt.PEEP] to SemH2O, [Interval] to Imin, and [Cycles Sign] to 3. 3. Select [OK]. Make sure that the ventilator activates sigh fimetion once every minute and that sigh is effective within continuous 3 ventilation cycles, 3.9 Electrical Safety Inspection NOTE © Perform electrical safety inspection after servicing or routine maintenance. Before the electrical safety inspection, make sure all the covers, panels, aud screws are correctly installed. © The electrical safety inspection should be performed once a year. 3.9.1 Electrical Safety Inspection Test 1, Perform protective earth resistance test a. Plug the probes of the safety analyzer into the protective earth terminal of AC power cord and into the 02 connector. b. Test the earth resistance with a current of 25 A. ¢. Verify the resistance is not larger than 0.1ohms (100 mohms). 4.17 the resistance is larger than 0..ohms (100 mohms) but smaller than 0.2ohms (200 ‘mobms), disconnect the AC power cord and plug the probe which is previously plugged into the protective earth terminal of AC power cord into the protective earth contact of the power outlet. Repeat steps a through c. 2. Perform the following earth leakage current tests @ noma polarity: @ reverse polarity: © normal polarity with open neutral; and @ reverse polarity with open neutral 3. Verify that the maxinmum leakage current does not exceed 500 A (0.5 mA) in the frst two tests. While for the last two tests, verify that the maximum leakage current does not exceed 1000 A (I mA). NOTE © Make sure the safety analyzer is authorized by certificate organizations (UL, CSA, or AAMI etc.), Follow the instructions of the aualyzer manufacturer.3.9.2 Electrical Safety Inspection Form Location: Techi ielan: Equipment: Control Number: Manufacturer: Model: SN: Measurement equipment /S Date of Calibration: INSPECTION AND TESTING Pass/Fail | Limit 1_| Protective Earth Resistance a Max: 019 Normal condition) | —* Earth Macs 2 Leakage NC: S00HA kag SFC: 1000yA. Single Fault WA condition(SFC) | —" For periodically performance, all the test tems included in the ELECTRICAL SAFETY INSPECTION FORM shall be performed. After the equipment is repaired with main unit disassembled. perform only test item I when the power supply PCBA is neither repaired nor replaced, or perform all the test items when the power supply PCBA is repaired or replaced.FOR YOUR NOTES4 Maintenance Menu and Software Upgrade 4.1 User Mi tenance 4.1.1 Overview This section introduces the functions of user maintenance. User maintenance is mainly used by the equipment maintenance personnel. It includes these functions: setup, defaults settings, data transfer, interface setting, system information, and CO2 in maintenance. 41.2 Setting Setting item Description ‘Language Set the screen display language, Unit Set Paw unit, weight unit, and CO2 unit, Gas supply Set O2 supply type. Ifthe gas supply type is set incorrectly, use of partial functions may be restricted (such as ©2 enrichment etc.). 414.1.3 Defaults Settings Palen'Typs | Gander | Height | IW | Ven'Mode | 07% og mk bor Peep, Toayets) | Awe | FTig | Sah eva Cydes Soh enzo | Umin rnin ‘Alamlimis Paw | MV Te | ota Tapnes | FO? ECO? | S502 | FR eno | Umin me | ber te mm | | Urine pee fos) fs io The ventilator settings can be adjusted as required. When [Use Current Settings] is sclected, the settings in Defaults Settings window will be replaced by the current settings. After the ventilator is powered on aud receives a new patient, it uploads the settings in Defaults Settings window automatically. ‘When [Restore Factory Defaults] is selected, the settings in Defaults Settings window will bbe restored to factory defaults. After the ventilator is powered on and receives a new patient, ituploads the settings in Defaults Settings window automatically. 4.1.4 Data Transfer ‘When the department which the ventilator is used in needs to configure multiple ventilators, the function of transferring settings is used to export or import the current settings and defaults of the ventilator setting items. All USB memories have space of more than 10M. available and arc in FAT32 or FAT format 424.1.4.1 Export Settings Insert the USB memory into the USB connector of the ventilator. Select [Setup]—[Maintain]—[User]—enter the required password [Data Transfer] Select [Export settings] to save the ventilator’s current settings and defaults to the USB ‘memor 4.1.4.2 Import Settings 1 Insert the USB memory into the USB connector of the ventilator, Select [Setup]-+[Maintain] + [User]— enter the required password [Data Transfer] Select [Import settings] to lond the settings in the USB memory to the ventilator. 4.1.4.3 Export Data ‘This fimetion is used for data export, which means to export patient demographics, current ng parameters, current alarm limits, and trend data of the ventilator in the format of To export data, 1 Insert the USB memory into the USB connector of the ventilator Select [Setup]— [Maintain] —[User]—enter the required password—[Data Transfer] [Export Data]. The system checks the availability of USB memory. Ifthe USB ‘memory is available and has sufficient space, the system exports patient demographics current setting parameters, current alarm limits, tabular trend, graphic trend, PEEPi ‘measured value, PO.1 measured value, Virap measured value, NIF measured value. calibration data, and event log, After data exporting is completed, select [Remove USB Memory] to remove the USB memory +34.1.5 Interface Setting Interface setting includes nurse call. 4.1.5.1 Nurse Call ‘The nurse call function means that the ventilator outputs nurse call signals to the nurse call, system when an alarm which meets the user set requirements occurs. The murse call function is activated only when: 1 2, 3 ‘The murse call function is switched on: An alann which meets the user set requirements occurs: ‘The ventilator is not in Alarm AUDIO PAUSED status. To set nurse call, L Select [Setup]--[Maintain] ~[User]—enter the required password [Interface Setting]—[Nurse Cal] Select [Switeh] and toggle between [ON] and [OFF]. [ON]: to switch on the nurse call function, [OFF]: to switch off the murse call function, Select [Signal Type] and toggle between [Pulse] and (Continuous). [Pulse indicates that the nurse call signals outputted are pulse signals lasting for one second. When multiple alarms occur simultaneously, only one pulse signal is outputted. Ifa new alarm occurs while the ongoing alarm is not cleared yet, a new pulse signal will bbe outputted, [Continuous]: indicates that the murse call signal lasts until the alarm ends, ie. the duration of a nurse call signal equals to that of the alarm. 44Select [Contact Type] and toggle between [Normally Open] and [Normally Closed] [Normally Open]: normally open signals are used to trigger the unsse call function, [Normally Closed}: nonnally closed signals are used to trigger the nurse call function. Select [Alarm Level] and set the alarm level for murse call signals triggered alarm. oo mee Select [Alarm Type] and select the alam type to which nurse call signals triggered alarm belongs. Ifno setting is made for [Alarm Level] or [Alarm Type], nurse call signals will not be triggered whatever alam occurs A\warNinc © Donot rely exclusively on the nurse call system for alarm notification. Remember that the most reliable alarm notification combines audible and visual alarm, indications with the patient’s cli -al condition. © Use the specified nurse call cable when connecting with the hospital’s nurse call, system through the nurse call connection port. Fi machine and produce electric shock hazard. ire to do so may burn the © Inspect the ventilator alarm signals periodically when using the nurse call function. 4.1.6 System Information 45