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ETERNITY SH300 User Manual

Ventilator system
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SH300 Ventilator System
User Manual
Beijing Eternity Electronic Technology Co. Ltd.

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  • Page 1 SH300 Ventilator System User Manual Beijing Eternity Electronic Technology Co. Ltd.
  • Page 2 Eternity customer service center. This product or any of its parts must be repaired in accordance with the written instructions provided by Eternity and by Eternity trained personnel.

  • Page 3: Table Of Contents

    Contents 1 Introduction ............................1 What‟s SH300? ........................1 1.1.1 Intended Use ........................... 1 Symbols ............................ 1 Definitions, Acronyms, and Abbreviations ................3 Structure ............................5 Frontview ..........................5 2.1.1 Front panel ..........................5 2.1.2 LCD screen .......................... 8 2.1.3 Expiratory module ........................ 9 Back panel ..........................
  • Page 4 System Checkout ........................29 Mains failure alarm test ......................30 Test humidifier performance ....................30 Alarm test ..........................30 Breathing system test ......................31 Cleaning and sterilizing ....................... 33 Cleaning and sterilizing ......................33 6.1.1 Cleaning: general guidelines ....................34 6.1.2 Disinfection and sterilization ....................
  • Page 5 Any use of the apparatus requires full understanding and strict observation of these instructions. The apparatus is only to be used for purpose specified here. One who is not authorized by Eternity shall not be allowed to open and dismantle the apparatus for maintaining, checking and repairing.

  • Page 6: Introduction

    1 Introduction 1.1 What’s SH300? The SH300 Ventilator System is designed to manage work of breathing, offer different modes of breath delivery, and help a practitioner select the most appropriate ventilator settings. The user interface is intended to be intuitive to anyone who knows how to operate a ventilator, and can be learned with minimal training.
  • Page 7 Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear in the equipment and manual. The symbols include: ON（Power） Type B equipment Warning or Caution, ISO OFF（Power） 7000-0434 Standby NOTE: refer to the manual Alternating Current Buzzer silence Alternating Current...

  • Page 8: Definitions, Acronyms, And Abbreviations

    1.3 Definitions, Acronyms, and Abbreviations CPAP Continuous Positive Airway Pressure Rate Respiratory rate.breath per minute fspn Respiratory rate of spontaneous breathing by the patient Total respiratory rate Delivered oxygen percentage Inspiratory resistance Lung compliance Exhaled minute volume MVspn Minute volume of spontaneous expiration by the patient Real time patient airway pressure flow Real time gas flow...
  • Page 9 Pressure control Ventilation PRVC Pressure Regulated Volume Control SIMV-V Synchronized Intermittent Mandatory Ventilation,mandatory type is VCV SIMV-P Synchronized Intermittent Mandatory Ventilation,mandatory type is PCV SIMV-PRVC Synchronized Intermittent Mandatory Ventilation,mandatory type is PRVC APRV Airway pressure release ventilation BIPAP Bilevel Positive Airway Pressure Pressure support ventilation INSP HOLD Manual closure of inspiration and expiration valves after inspiration...

  • Page 10: Structure

    Expiratory module: BTPS. WARNING Independent means of ventilation (e.g. a self-inflating manually powered resuscitator with mask) should be available whenever the SH300 Ventilator System is in use. WARNING Do not use antistatic or electrically-conductive breathing tubes, hose or mask. 2.1.1 Front panel 1.Display 2.Controls and Indicators3.Holder4.Knob...
  • Page 11 controls and indicators Alarm silence key. Turns off alarm sound for 2 minutes . this within two minutes , press this key to restore the alarm Alarm silence sounds again, and Again thetiming. Clears inactive alarms Alarm reset When the yellow light on the screen lock key is lit, pressing other keys (including the Knob) has no effect until you press the screen lock key again.
  • Page 12 When the battery charging, orange lamp lights beside DC DC STATUS Charge lamp STATUS.when the battery is full，the lamp off Push to select a menu item or confirm a setting. Turn Knob clockwise or counterclockwise to scroll menu items or change settings.

  • Page 13: Lcd Screen

    2.1.2 LCD screen Figure 2-2 main interface Parameters monitored area Parameters monitored on the main interface are: MV, VTE, PEEP, FiO .etc.the upper and lower limit can be set on the alarm settings menu. Menu bar Turn knob touch screen setting Modes,Monitor Data,Alarms,Configuratian,Calibration,Start/by...

  • Page 14: Expiratory Module

    2.1.3 Expiratory module Figure 2-3 Expiration module of SH300 Pressing down the lock locking device on the exhalation valve seat, it is in the unlocked state, and rotate it counter clockwise about ten degrees to take off expiratory module, and then disinfect it.

  • Page 15: Operating Guide

    3 Operating Guide 3.1 Starting System Step 1 Connect power supply Plug the power cord into AC power outlet. The power indicator light will be light when power is connected and the swith turn on Step 2 Power On Set power switch to ON (“ ”).

  • Page 16: Setup Ventilation Mode

    Move the blue cursor to "Apply", and press the knob the display screen switches to main interface, see figure 3-3 Figure 3-3 Standby interface NOTE: If you want to change the Patient mode , please TURN OFF the ventilator and then turn on. 3.2 Setup ventilation mode Step 1 Turn the knob or touch the screen...

  • Page 17: Ventilation Mode Introduction

    Step 2 Turn the cursor will move by selected item. Push the Knob, selected item will be focused to display like right figure. In the pop-up menu , you can set the required parameter values see figure 3-5 Figure 3-5 Parameter interface Setting other ventilation mode is similar to the above.

  • Page 18: Vcv+Sigh

    VCV mode, patient effort detected Figure 3-7 Figure 3-8 shows VCV breath delivery when there is a combination of VIM and PIM breaths. And Tb is the breath period in seconds. VCV mode VIM and PIM breaths Figure 3-8 Caution ： Setting of trigger pressure‟...

  • Page 19: Cpap/Psv

    Figure 3-9 SIMV breath cycle (mandatory and spontaneous intervals) Warning This mode may cause insufficient ventilation or apnea if patient „state becomes depravation. 3.3.4 CPAP/PSV Figure 3- CPAP Waveform In CPAP/PSV mode, inspiration is usually initiated by patient effort. Breaths are initiated via pressure or flow triggering, whichever is currently active.

  • Page 20: Pcv

    Figure 3-11 PSV Waveform In figure 3-11 breath number 1 represents the flow tracing which occurs when the PSV level is insufficient to meet the patient demand. Breath two shows resolution after increasing the PSV level slightly. 3.3.5 PCV PCV (Pressure Control Ventilation) is mandatory ventilation with preset respiratory frequency and pressure limit.

  • Page 21: Bipap

    Figure 3-12 APRV Waveform 3.3.7 BIPAP BIPAP mode is a mixed mode of ventilation that combines the attributes of mandatory and spontaneous breathing. In BIPAP mode, mandatory breaths are always pressure-controlled, and spontaneous breaths can be pressure-supported. In the absence of spontaneous breathing, BIPAP resembles A/C mode, except that BIPAP establishes two levels of positive airway pressure, similar to having two levels of PEEP.

  • Page 22: Prvc

    3.3.8 PRVC Pressure Regulated Volume Control (PRVC) breaths are pressure breaths where the pressure level is automatically modulated to achieve a preset volume. PRVC breaths are: Controlled by pressure (inspiratory + PEEP) and volume; Limited by pressure (inspiratory + PEEP + margin); Cycled by time.

  • Page 23: Alarm Settings Menu

    3.4 Alarm Settings menu Turn the knob or touch the screen to select “Alarms”, the following menu appears on the screen. Figure 3 -14 Alarm settings interface 3.4.1 Setting alarm parameters There are the following parameters can be set: MV: Higher limit and lower limit, unit: L; Pressure: Higher limit and lower limit, unit: cmH VTE: Higher limit, unit: L Rate: Higher limit, unit: bpm...

  • Page 24: Alarm Log Submenu

    3.4.2 Alarm log submenu To view the alarm log, turn the knob to select the Alarm Log button and press it, the Alarm Log submenu appears. See the following figure. Figure 3-15 Alarm log submenu The alarm log shows alarm events in order of occurrence, with the most recent event at the top of the list.

  • Page 25: Monitor Data

    NOTE: The alarm log can store up to 100 of the most recent entries. When the alarms happen, the ventilator saves the alarm type and time automatically. When ventilator is powered down or experiences a total loss of power for a finite duration,The alarm log will exist continuely.
  • Page 26 1.System Info Turn the knob or touch the screen, select System Info button, push it and enter into System Info menu. In the System Info menu, the current software version of all boards is listed and display the run time of this device. Figure 3-19 System Info interface 2.Date and Time Turn the knob or touch the screen, select...
  • Page 27 4.Language Turn the knob or touch the screen to select Language dropdown listbox as right figure. Push it and drop down other options,turn the Knob to select wanted option and push again to confirm Figure 3-22 Language interface 5.Waveform Turn the knob or touch the screen to select waveform dropdown listbox as right figure.

  • Page 28: Ventilation Parameters Setup

    3.7 Ventilation parameters setup Turn the Knob in main windows to select VT button as shown in right figure. Press the Knob and rotate it to adjust VT value until the wanted, and then press it again to confirm. Figure 3-25 Ventilation parameters setup interface When TI is adjusted, the limit by VT, Rate and Pause is considered, if the set is limited, please check those...

  • Page 29: Assist Function Operating

    Figure 3 -27 Information bar 1. modes display area 2. Trigger and Nebulizer symbol display area 3. operating information display area 4. alarm information display area 5. silence symbol display area 6. power information display area 7. system time and lock state 3.9 Assist function operating 3.9.1 Freeze The FREEZE button freezes the current screen and suspends real-time update of data until...

  • Page 30: Install And Connection

    VENTLATOR BREATHING SYSTEM, measured with respect to the PATIENTCONNECTIONPORT, may increase. WARNING :Eternity suggests that user should use the breathing tubes, humidifier and bacteria filter that had get CE mark. CAUTION To avoid equipment false alarm caused by high strength electric field: ...

  • Page 31: Assembling The Ventilator

    4.1 Assembling the ventilator Assemble your SH300 ventilator‟s cart using the following instructions. The ventilator body is easily attached to the base by means of four thumbscrews. Figure 4-1 Ventilator 4.2 Assemble of the cart You should assemble the cart and ventilator before use., install the ventilator onto the connecting plate with four screws(see figure 4-3).

  • Page 32: Connect Tube

    Screws down Screws down the bottom the bottom Figure 4-4connection for the Ventilator 4.3 Connect tube Figure 4-5 connection for patient tubing You can connect the patient tubing as figure 4-5, and then connect it with ventilator. Nebulizer Figure 4-6 Attaching a Nebulizer You can use an in-line nebulizer with the Vela ventilator.
  • Page 33  For two-phase alternating current circuit user, do not attempt to switch earth line and zero line. SH300 ventilator belongs to Class I equipment specified in EN60601-1 Medical Electrical equipment: Part one: General requirement for safety.  Low battery alarm may be occur, if you power on the ventilator with it do not have external power supply for a long time.

  • Page 34: Preoperative Checkout

    5 Preoperative Checkout 5.1 Preoperative Checkout procedures Test interval Preoperative Checkout should be done in the following situation: Before use of the first patient each day. Before use of each patient. After repair or maintenance. Test schedule is given in the table below: Before use of the first patient each day Before use of each patient System check:...

  • Page 35: Mains Failure Alarm Test

    5.3 Mains failure alarm test 1. Turn power switch to “ ”, stand-by interface appears after a while. 2. After operating for 5 minutes, pull out power cord. 3. Make sure that power off failure alarm occurs , which has the following characteristics: Alarm sound;...

  • Page 36: Breathing System Test

    to A/C mode from SPONT mode. High breath rate alarm test Set the upper limit of Rate to 20, and adjust Rate to 30 ,one minute later, high breath rate alarm occurs. 10. Low breath rate alarm test Set the lower limit of Rate to 20, and adjust Rate to 16 ,one minute later, low breath rate alarm occurs.
  • Page 37 4. Check tidal volume Cut off the gas supply, turn to the VCV ventilation mode, it should be 0 of the tidal volume monitor. Recover the gas supply and adjust Vt to 700ml, check the tidal volume monitor is at a range of ±20% 5.

  • Page 38: Cleaning And Sterilizing

    6 Cleaning and sterilizing WARNING Use a cleaning and sterilizing schedule that conforms to your institution’s sterilization and risk-management policies.  Refer to the material safety data policy of each agent.  Refer to the operating and maintaining manual of all the sterilizing equipments.

  • Page 39: Cleaning: General Guidelines

    Caution： Patient circuit tubing  If users select patient circuit tubing by themselves, Eternity suggests they should use breath tubing that gets CE mark. Take off expiratory module, dismantle it After disinfecting and airing, and disinfect them respectively to use install the expiratory module steaming.

  • Page 40: Disinfection And Sterilization

    1． Wash parts in warm water and mild soap solution. 2． Rinse parts thoroughly in clean, warm water (tap water is fine)。 3． Eternity recommends that you inspect all parts at every cleaning. Replace any damaged parts.。 4． Whenever you replace parts on the ventilator, make sure it can work in a good condition before connect it to patient.

  • Page 41: Cleaning Method For The Exhalation Valve Assembly

    liquid in pressure measuring line. 6.1.4 Cleaning Method for the Exhalation Valve Assembly Remove the Exhalation Valve Assembly for Cleaning 1. Press and hold the release latch on the lower right left of the exhalation valve housing. 2. Grasp the exhalation valve body, and then gently pull it free from the housing. 3.

  • Page 42: User Maintenance

    It is recommended that you replace damaged parts with components manufactured or sold by Eternity. After any repair work, test the unit to ensure it complies with the manufacturer‟s published specifications. Contact the nearest Eternity Service Center for service assistance. In all cases, other than where Eternity‟s warranty is applicable, repairs will be made at Eternity‟s current list price for the...

  • Page 43: Useful Life Estimation

    The useful life of the following parts should be considered in normal environment and operating requirements. Note: if the Exhalation valve diaphragm, oxygen sensor, the respiratory pipe over the use of time, there will be service tips, please contact the nearest Eternity customer service center. Face mask, Patient circuit...
  • Page 44 1.Calibrate Press sensor Turn the Knob to select Pressure sensor button, see right figure. push the Knob, enter into pressure sensor calibration menu. see right figure. Select do button, push Knob to calibrate If succeed, the word Calibration completed will be displayed on the screen Figure 7-2 Calibrate Press sensor interface Figure 7-3 Calibrate Press sensor interface...
  • Page 45 2.Calibrate flow sensor Turn the Knob to select Flow sensor and press it, see right figure. The other operation like the press sensor calibrate. Figure 7-4 Calibrate flow sensor interface 3.Calibrate oxygen sensor Turn the Knob to select oxygen sensor and press it, see right figure.
  • Page 46 4.Calibrate Exp. Valve Turn the Knob to select Exp Valve Cal and press it, see right figure. Calibrating procedure refer Calibrating pressure sensor. The other operation like the press sensor calibrate. NOTE: Before calibrating expiratory valve, ensure leakage! Figure 7-6 Calibrate Exp. Valve interface 5.Service Modes Used by after-sales engineers to verify machine use...

  • Page 47: Assembling The Expiratory Module

    6.Touch Screen Cali For touch screen verification Figure 7-8 Touch Screen Cali interface 7.3 Assembling the expiratory module Expirtory valve diaphragm Figure 7-9 assembling for expiratory valve body Figure 7-10 assembling for diaphragm Assembling steps: 1. Insert the support plate into diaphragm. 2.

  • Page 48: Replacing Fuses

    Exhalation valve seat Exhalation valve Locking device Figure 7-11 installing expiratory module CAUTION : If the diaphragm damages, please contact Eternity. 7.4 Replacing fuses WARNING Disconnect from power supply before replacing fuses, otherwise that can injure operator ,even death. WARNING Replace fuses with only those of the specified type and current rating, otherwise that can damage the equipment.

  • Page 49: Maintaining Battery

    If improper maintenance makes battery damage, replace it in time to avoid liquid of battery corroding the apparatus. Replace the battery, please contact Eternity service representatives. Replacement Eternity recommends the battery must be provided by Eternity or agency get the warrant. CAUTION An authorized Eternity services representative can replace battery. If not to use the battery for long-time, please contact Eternity service representatives to disconnect battery.

  • Page 50: Replace O 2 Sensor

    Using a cross screwdriver, lift open the battery box cover. Remove the battery package from battery box and unplug the connector from cable. Replace with battery package indicated by Eternity and plug the connector reliable. Using the same cross screw driver, screw in tightly.

  • Page 51: Recommended O 2 Sensor

    7.7.2 Calibrate O sensor WARNING: Do not perform the calibration steps when the system connected with patient. WARNING: If operating pressure is not equal with calibrating pressure, the accuracy of reading may exceed range stated. WARNING: When to calibrate O sensor, ambient pressure must be equal with monitoring pressure of delivering O in the patient circuit.

  • Page 52: Replacing Fan Filter

    Every 500 hours, the fan filter should be checked and cleaned if necessary. The fan filter is located the rear enclosure of display screen.To clean the filter, remove it from its recess and immerse in warm soapy water. Rinse thoroughly and dry thoroughly before replacing in the SH300. .Replacing steps: 1.

  • Page 53: Alarm And Troubleshooting

    8 Alarm and Troubleshooting WARNING No repair should ever be undertaken or attempted by anyone without proper qualifications and equipment. 8.1 About alarm CAUTION If alarm occurs, protect patient safe firstly, and then go to diagnose fault or serviceit necessarily. WARNING Never leave patient unattended when alarm silence is activated.

  • Page 54: Alarm Message List

    8.2 Alarm message list Message Priority Alarm definition Operator action !!VTE HIGH Medium V greater than high limit for 4 Check patient and settings. breath cycles continuously. Consider whether patient‟s compliance resistance has changed. !!VTE LOW Medium V less than low limit for 4 breath Check patient and settings.

  • Page 55: Troubleshooting

    !!!APNEA High The set apnea interval has elapsed Check patient and without the ventilator, patient, or settings. operator triggering a breath. The ventilator has entered apnea ventilation. !!!PRESSURE High Airway pressure greater than high limit Check patient, patient HIGH for 2 breath cycles continuously. circuit, and endotracheal tube.

  • Page 56: Specifications And Operation Theory

    9 Specifications and Operation Theory 9.1 Physical specification All specifications are approximately, maybe changed at any moment without notice. CAUTION Do not put SH300 into the shock environment. CAUTION Do not lay the heavy on the top. Size 400mm(H)×303mm(W)×250mm(D) Weight...

  • Page 57: System Technical Specification

    9.3 System technical specification Gas supply Composition ,Air (All gas must be medical level) Pressure 0.28MPa～0.6MPa ≤100L/Min Velocity of flow Connector DISS-male，DISS-female，NIST（ISO 5359） Power supply Voltage & Frequency 110V～240V，50Hz～60Hz 2A Power 250V 2A φ5X20（T） Fuse <0.2Ω Earth resistance Inspiratory Conical connectors (ISO5356) expiratory port At flow of 60L/min for adult use, inspiratory resistance ≤0.6kPa;...

  • Page 58: Operation Principle

    9.4 Operation principle Figure 9-1 SH300 Ventilator System operation principle diagram...

  • Page 59: Performance Parameters

    9.5 Performance parameters 9.5.1 Setting ventilation mode Ventilation mode Adjustable respiratory parameters VCV mode VT, TI, Rate, Pause, P-tr/F-tr,PEEP, FiO VCV+Sigh mode VT, TI, Rate, Pause, P-tr/ F-tr,PEEP, FiO PCV mode Pinsp, TI, Rate, P-tr/ F-tr,PEEP, FiO SIMV（VCV） mode VT, TI, Rate, Psup, P-tr/ F-tr,PEEP, FiO SIMV（PCV）...
  • Page 60 Adult mode Item Range Resolutio Accuracy Remark 50~2500ml 10ml ±20 ml or ±15%, ±1bpm (≤10bpm); Rate 4 ~ 100bpm 1bpm ----- ±10% (other) ±1bpm (≤10bpm); Rate in SIMV 1~ 40bpm 1bpm ----- mode ±10% (other) 0.1s~12s 0.1s ---- ±0.1s (0～1s); ±10％...

  • Page 61: Monitoring Performance

    9.5.3 Monitoring performance Item Range Resolution Accuracy 0~4000 mL 1 mL ± 20 mL or ± 15% (other) 0~4000 mL 1 mL ± 20 mL or ± 15% (other) 2 bpm (≤20 bpm); ±10% (other) 1 bpm 0～100 bpm 2 bpm (≤20 bpm); ±10% (other) fspn 0~100 bpm 1 bpm...

  • Page 62: O 2 Monitoring Specification

    9.5.4 O monitoring specification Response time: Not more than 15 seconds Type of O sensor: Chemical fuel cell Useful life: 12 months (normal operating) Operational principle: monitoring modules can monitor and display oxygen concentration of the patient circuit, and contain one oxygen sensor.

  • Page 63: Setting Alarm Parameters

    All low limits of parameters in above table may not be set up the high limits, nor may the high limits be set below the low limits. 9.6 Order information Description specification Stock number Exhalation valve diaphragm SH300-30-03 Exhalation valve SH300-30-00 One-way membrane SH300-30-05 Filter VS-21-01...

  • Page 64: Electromagnetic Compatibility

    9.7 Electromagnetic Compatibility Changing or reassembling this equipment without Eternity‟s authorization may cause electromagnetic compatibility problems. Contact with Eternity for assistance. Designing and testing this equipment is in accordance with the following stipulations. WARNING using cell phone or other radio radiant equipment near this product may cause malfunction.
  • Page 65 EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The SH300 Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of SH300 Ventilator should assure that it is used in such an environment. Electromagnetic...
  • Page 66 Guidance and manufacture’s declaration – electromagnetic immunity The SH300 Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of SH300 Ventilatorshould assure that it is used in such an environment. Immunity IEC 60601 test...
  • Page 67 If the measured field strength in the location in which theSH300 Ventilator is used exceeds the applicable RF compliance level above, the SH300 Ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating theSH300 Ventilator.
  • Page 68 Recommended separation distances between portable and mobile RF communications equipment and the SH300 Ventilator The SH300 Ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SH300Ventilatorcan help prevent...

  • Page 69: Manufacturer Responsibility

    Eternity who reserves the copyright. Everything written in this manual is considered to be correct. Eternity is not legally responsible for any mistakes printed within and any damages caused by incorrect installation and operation. Eternity does not supply privileges endowed by the patent law to any other parties.

  • Page 70: Warranty

    1. Obtain the rights of return Contact with the customer service of Eternity by informing them the number and type of the product. The number is marked on the surface of the product. Return is unacceptable if the number cannot be identified.
  • Page 71 SH300 Ventilator System User Manual Copyright:Beijing Eternity Electronic Technology Co. Ltd. Version：19.01 Modified date: Aug. 2019 Printed for the first time in 2019...

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