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Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.

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,
rental, adaptation, translation or any other derivative work of this manual in any manner
whatsoever without the written permission of Mindray is strictly forbidden.

,

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and SynoVent are the trademarks, registered or

otherwise, of Mindray in China and other countries. All other trademarks that appear in this
manual are used only for informational or editorial purposes. They are the property of their
respective owners.

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Summary of Contents for SynoVent E5

Page 1: ...SynoVent E5 Ventilator Operator s Manual...

Page 2: ......

Page 3: ...I 2010 2014 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights Reserved For this Operator s Manual the issue date is April 2014...

Page 4: ...onfidential information Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden Release amendment reproduction distributio...

Page 5: ...e of this product only if all installation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel the electrical installation of the rele...

Page 6: ...f the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel This warranty shall not extend to Malfunction or damage caused by...

Page 7: ...7 Hamburg GERMANY Tel 0049 40 2513175 Fax 0049 40 255726 Manufacturer Shenzhen Mindray Bio Medical Electronics Co Ltd Address Mindray Building Keji 12th Road South High tech industrial park Nanshan Sh...

Page 8: ...close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical pr...

Page 9: ...Install the Display onto the Pendant 3 2 3 2 Connect the Power Supply 3 4 3 2 1 Connect the System Power Supply 3 4 3 2 2 Connect the Main Unit Power Supply 3 5 3 2 3 Connect the Compressor Power Sup...

Page 10: ...5 8 Select Tinsp I E 5 4 5 9 Set TV f Source 5 4 5 10 Set Sigh 5 4 5 11 Set IP Address 5 5 5 12 Manage Configurations 5 5 5 12 1 Restore the Latest Configuration Automatically 5 5 5 12 2 Set Power on...

Page 11: ...imits 6 20 6 9 Ventilate the Patient 6 20 6 10 Ventilation Parameters Monitoring 6 21 6 11 Enter Standby 6 23 6 12 Turn the System off 6 23 7 CO2 Monitoring 7 1 7 1 Introduction 7 1 7 2 Prepare to Mea...

Page 12: ...1 Alarm Test 9 7 9 11 1 Battery in Use Alarm 9 7 9 11 2 Battery Depletion Alarm 9 7 9 11 3 Paw Too High Alarm 9 8 9 11 4 TV Not Achieved Alarm 9 8 9 11 5 MV Too Low Alarm 9 8 9 11 6 O2 Supply Pressure...

Page 13: ...cal Safety Inspection 11 10 11 9 1 Auxiliary Electrical Outlet Test 11 10 11 9 2 Electrical Safety Inspection Test 11 11 11 10 Water Build up in the Flow Sensor 11 12 11 10 1 Prevent Water Build up 11...

Page 14: ...s D 1 D 1 Physiological Alarm Messages D 1 D 2 Technical Alarm Messages D 2 E Factory Defaults E 1 E 1 CO2 Module E 1 E 2 Alarm E 1 E 3 Ventilation Mode E 2 F Symbols and Abbreviations F 1 F 1 Symbols...

Page 15: ...a potential hazard or unsafe practice that if not avoided could result in death or serious injury CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in minor per...

Page 16: ...o any barrier which can prevent cold air from flowing resulting in equipment overheat Do not open the equipment housings All servicing and future upgrades must be carried out by the personnel trained...

Page 17: ...ctrical outlets are configured the voltage and current specifications of the devices connected to the electrical outlets must be within the permissible ranges for those of the electrical outlets When...

Page 18: ...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 venti...

Page 19: ...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...

Page 20: ...ontrols Keep this manual close to the equipment so that it can be obtained conveniently when needed The software was developed in compliance with IEC 60601 1 4 The possibility of hazards arising from...

Page 21: ...Oxygen supply connection Pneumatic outlet Flow sensor Expiratory port Inspiratory port Unlock Nebulizer connection Compressor status indicator Nurse call connection Compressed air outlet of the compr...

Page 22: ...ou will help prevent bringing potential negative consequences to the environment and human health For more detailed information with regard to returning and recycling this product please consult the d...

Page 23: ...ained must not perform any operation on it 2 1 2 Contraindications There are no absolute contraindications for this product However for some patients who suffer from special diseases special ventilati...

Page 24: ...2 2 2 2 Equipment Appearance 2 2 1 Front View 4 1 2 3 5 6 7 8 9 10 11 12...

Page 25: ...st lung 6 Expiratory hose 7 Inspiratory hose 8 Support arm Supports the patient s breathing hoses 9 Display 10 Expiratory filter Prevents water and bacteria inside the patient hoses from entering the...

Page 26: ...supply connection with filter water trap 4 CO2 calibration connection One multiplex connector for calibrating inspiratory and expiratory flows and supplying power for the external CO2 analyzer 5 Fan 6...

Page 27: ...oint Eliminates the ground potential difference between different devices to ensure safety 2 2 3 Air Compressor The air compressor has standby function In the standby mode the compressor starts to del...

Page 28: ...ssed air outlet 6 Central pipeline gas supply inlet 7 Power switch 8 Mains power inlet with fixing pressure plate 9 Air intake vent with dust filter 10 Hourmeter The hourmeter indicates the accumulate...

Page 29: ...of the ventilator re do system check each time when accessories or components like hose humidifier and filter are replaced Adding accessories or other components to the ventilator can increase system...

Page 30: ...splay with the screw holes 2 Install the three screws to fix the display 3 Insert the three screw plugs 4 Connect the display connection line to the Video input output port and tighten the two fixing...

Page 31: ...ndant pole 2 Tighten the knob for fixing block 3 Put the display onto the display bracket base disk and align the display with the screw holes 4 Install three screws to fix the display 5 Put the three...

Page 32: ...System Power Supply A AC power cord B AC Power cord retainer C Screw 1 Plug the AC power cord into the AC power outlet 2 Place the AC power cord retainer above the power outlet and align the retainer...

Page 33: ...unit power cord B Main unit power cord retainer C Screw 1 Plug the main unit power cord into the power outlet 2 Place the main unit power cord retainer above the power outlet and align the retainer w...

Page 34: ...3 6 3 2 3 Connect the Compressor Power Supply A Compressor B Compressor power cord Plug the compressor power cord into the auxiliary electrical outlet specially for compressor directly A B...

Page 35: ...eals at the connectors are in good condition If any damage is found do not use the hose Replace the defective seal to avoid leakage 2 Plug the supply hoses and connectors into the corresponding supply...

Page 36: ...nd 1000 kPa can impair the performance of the ventilator but will not cause any hazard arising from high pressure gas 3 4 Install the Support Arm A Fixing block knob B Fixing block C Hose hook D Suppo...

Page 37: ...the support arm upward only lift the support bar to the desired position with no need to push the blue button Support arm joint F pull support arm joint F upward or downward to the desired position H...

Page 38: ...3 5 Install the Water Traps A Water trap on the breathing hose B Water trap on the expiration valve assembly Rotate to push in the water trap upward Make sure that the water trap is installed in place...

Page 39: ...Mount the filters onto the inspiratory and expiratory ports 2 Connect the inspiratory filter to the water trap via the hose Connect the other end of the hose to the Y piece 3 Connect the expiratory fi...

Page 40: ...eps described here are only for reference 3 7 1 Install the Humidifier onto the Ventilator A Humidifier B Humidifier sliding wheel C Humidifier bracket fixed seat D Screw E Humidifier inlet F Humidifi...

Page 41: ...he hose Then connect the water trap to the Y piece via the hose 6 Connect the expiratory filter to the water trap via the hose Then connect the water trap to the Y piece via the hose 7 Place the breat...

Page 42: ...d seat F Screw G Beam 1 Loosen the knob for fixing block Put the fixing blocking onto the pendant beam 2 Tighten the knob for fixing block 3 Align the humidifier sliding wheel with the humidifier brac...

Page 43: ...ing the humidifier 3 8 Install the Nebulizer A Nebulizer connector B Nebulizer hose C Nebulizer 1 Connect one end of the nebulizer hose to the nebulizer connector and the other end of the hose to the...

Page 44: ...e and oxygen mix 3 9 Install the CO2 Module A Fastening screws for CO2 module mounting plate B CO 2 module C Fastening screws for CO2 module D W ater trap E Sam pling line F CO 2 calibration connectio...

Page 45: ...ilator s CO2 calibration connection 4 Connect one end of the sampling line to the water trap and then mount the water trap onto the CO2 module Connect the other end of the sampling line to the patient...

Page 46: ...3 18 FOR YOUR NOTES...

Page 47: ...en The display shows the software screen of the ventilator system You can select and change settings by touching the screen 2 Fixed hard keys The fixed hard keys are provided for rapid access to the v...

Page 48: ...lator is operating on AC power source Flash when the ventilator is operating on battery power Extinguished when the ventilator is not connected to the AC power source or the ventilator is not equipped...

Page 49: ...text prompt is displayed underneath the icon The icon for inspiratory trigger is which is prompted for one second 5 Alarm silence symbol and countdown field Displays the time remaining in the 120s ala...

Page 50: ...dio of an active alarm for 120 seconds When 120 seconds expires the system exits alarm silenced status automatically and resumes alarm audio If a new alarm occurs during the alarm silenced period the...

Page 51: ...rm your setting Turn the control knob clockwise or counterclockwise to scroll through the menu options or change your settings 8 System switch Push and hold push the system key to turn on off the syst...

Page 52: ...14 When pushed the LED in the upper left corner of this key is lit and the ventilator enters locked status The prompt message field displays Panel Locked Push the Lock key to unlock the panel During...

Page 53: ...m pressure flow and volume waveforms data Up to two types of spirometry loops are displayed at a time To select the desired loop 1 Select Spirometry on the main screen 2 Select the desired loop to be...

Page 54: ...the physiological parameter value at each time moment You can access the following graphic window by selecting Trends and or selecting the button for switching between Tabular and Graphic 1 Graphic s...

Page 55: ...ters include Ppeak Pplat Pmean and PEEP Volume parameters include TVi TVe TVe spn MV MVspn and MVleak Time parameters include ftot fmand and fspn Other parameters include Ri Re Cdyn RSBI WOB FiO2 FiCO...

Page 56: ...ark indicates a high priority alarm event and yellow a medium or low priority alarm event 2 Time field displaying the time corresponding to the cursor 3 Cursor column displaying parameter values measu...

Page 57: ...lution button which can be set to 1 min 5 min 10 min 15 min 30 min and 1h 8 Horizontal scroll bar indicating the position of the currently displayed trend data in the entire trend database 9 Cursor co...

Page 58: ...eze key to unfreeze is prompted on the screen The system enters freeze status Cursors appear on the waveforms and loops All displayed waves and loops are frozen namely they are not refreshed The data...

Page 59: ...clockwise to move the cursor to view the frozen spirometry loops Exit freeze status In freeze status push the Freeze key to exit the freeze status In freeze status if no operation is performed on the...

Page 60: ...4 14 FOR YOUR NOTES...

Page 61: ...2 Spirometry Loops 1 Select Spirometry 2 Select the loops to be displayed 5 1 3 Measured Values On the waveforms spirometry loops or trends screen the right side of the screen is divided into three p...

Page 62: ...the selected color is suggested for the color of waveform related alarm limits The following table lists the waveforms waveform related parameters waveform related spirometry loops and waveform relate...

Page 63: ...sh the Menu key Select System and then Ventilator 2 Select LCD Brightness and select the appropriate value ranging from 1 to 10 for screen brightness The value 10 is for the brightest and 1 the least...

Page 64: ...et O2 Monitoring to OFF if oxygen concentration monitoring function accompanying the ventilator is not needed In this case O2 Monitoring Off is prompted on the screen 5 8 Select Tinsp I E 1 Push the M...

Page 65: ...configuration There are user adult configuration and user pediatric configuration based on patient type Latest configuration In actual applications you may change some settings which however may not...

Page 66: ...en Load Config 3 Select your desired configuration 5 13 View System Information 5 13 1 Version Information Push the Menu key Select Syst Info and then Versions You can view the version information of...

Page 67: ...ct Tool Export Export Screen The system checks the availability of USB memory If the USB memory is available and has sufficient space the system exports the last captured screen 5 14 2 Export Data Dat...

Page 68: ...5 8 FOR YOUR NOTES...

Page 69: ...d the battery indicator flashes and the low level alarm Battery in Use is triggered 3 Reconnect AC power and operate the ventilator on AC mains Make sure that the AC power LED is lit the battery indic...

Page 70: ...e 6 3 Power on Self test Power on self tests include CPU self test Memory RAM and ROM selft test Watchdog self test Analog Digital A D converter self test Temperature sensor self test Buzzer self test...

Page 71: ...ried out Monitoring Off indicates that the sensor monitoring function may not be turned on when O2 sensor test is being carried out When system check is being performed the system prompts Running on t...

Page 72: ...meters that the user chooses ATRC can be set on the parameter setting interfaces of each mode 1 Select a ventilation mode and select ATRC to enter the ATRC interface 2 Set the intubation type tube dia...

Page 73: ...he set tidal volume but not more than 2 L maximum in NIV mode 6 6 3 Set Ventilation Type To set up ventilation type 1 If the ventilator is not in Standby push the Standby key and select Ok from the po...

Page 74: ...for setting ventilation mode Selecting displays more keys for setting ventilation mode The ventilator can be configured with the following ventilation modes V A C P A C CPAP PSV V SIMV P SIMV PRVC Du...

Page 75: ...purpose of matching the doctor s ventilation strategy to the maximum In the SIMV mode if patient apnea occurs the ventilator ventilates the patient at the apnea ventilation frequency in place of the p...

Page 76: ...dal volume is delivered to the patient at the inspiratory flow within the inspiration time The airway pressure varies according to the resistance and compliance of the patient s lungs and thorax When...

Page 77: ...expiratory pressure 11 ATRC Automatic tube resistance compensation In V A C under NIV you need to set the following ventilation parameters 1 O2 Oxygen concentration 2 TV Tidal volume 3 Tinsp or I E T...

Page 78: ...he expiratory phase synchronous trigger is supported Specifically next mechanical ventilation can be delivered in advance when patient inspiratory effort is detected The following figures show typical...

Page 79: ...en it detects that patient inspiratory effort reaches the preset inspiration trigger level Time of pressure rising and pressure support level are set by the user At the beginning of inspiratory phase...

Page 80: ...ea ventilation PEEP Apnea vent cycle I E 1 2 Tslope Apnea time Time In CPAP PSV under non NIV you need to set the following ventilation parameters 1 O2 Oxygen concentration 2 Tslope Time of pressure r...

Page 81: ...on or pressure control ventilation in SIMV mode is delivered within the trigger window and is delivered automatically at the end of the trigger window if not triggered within the trigger window Outsid...

Page 82: ...equency of SIMV 5 Flow Inspiratory flow 6 Plimit Pressure limitation 7 PEEP Positive end expiratory pressure 8 Exp Expiration trigger level 9 Psupp Pressure support level 10 Tslope Time of pressure ri...

Page 83: ...of inspiration 3 Tinsp Time of inspiration 4 fSIMV Frequency of SIMV 5 Tslope Time of pressure rising 6 PEEP Positive end expiratory pressure 7 Exp Expiration trigger level 8 Psupp Pressure support l...

Page 84: ...of 3 cmH2O and the maximum pressure does not exceed the pressure high alarm limit 5 cmH2O The first PRVC delivered is experimental ventilation mode for the purpose of calculating compliance and resis...

Page 85: ...resistance compensation In PRVC under NIV you need to set the following ventilation parameters 1 O2 Oxygen concentration 2 TV Tidal volume 3 Tinsp or I E Time of inspiration or ratio between the inspi...

Page 86: ...of low pressure phase inspiratory trigger transforms to high pressure gas delivery Within the trigger window of high pressure phase expiratory trigger transforms to low pressure gas delivery The foll...

Page 87: ...a ventilation 10 fapnea Frequency of apnea ventilation 11 F Trig or P Trig Inspiration trigger level 6 7 10 APRV APRV is airway pressure release ventilation It can be seen as periodical short period a...

Page 88: ...ntilation 8 fapnea Frequency of apnea ventilation 6 8 Change Alarm Limits You can change the alarm limits for Paw MV ftot and TVe by pushing the Alarm Setup key and selecting Alarm Limits You can chan...

Page 89: ...urated water vapor status Setting parameter Description TV The gas volume the patient inspires or expires each time during resting breathing O2 The volume percentage of oxygen in the mixed gas deliver...

Page 90: ...flow is essential for flow trigger The ventilator adjusts base flow from 2 to 20 L min automatically to maintain PEEP and establish baseline for patient triggering int PEEP Available only in V A C mo...

Page 91: ...Rapid shallow breath index that is defined as fspn TVespn WOB Work of breath NIF Negative inspiratory force P0 1 The pressure drop in the first 100 ms when the patient starts spontaneous breathing PE...

Page 92: ...6 24 FOR YOUR NOTES...

Page 93: ...ed the concentration of CO2 is calculated End tidal CO2 concentration reading is using the highest values respectively of the temporal CO2 curve The measurement provides 1 CO2 waveform 2 End tidal CO2...

Page 94: ...fixer and then connect the CO2 components as shown below 2 By default the CO2 module is in measure mode When the CO2 module is connected the CO2 Startup message is displayed on the screen 3 After star...

Page 95: ...g the module If the collected water reaches a certain amount you should drain it to avoid blocking the airway Dispose of accumulated fluids in accordance with the hospital policy or your local regulat...

Page 96: ...nd infrared light source are automatically turned off to extend the service life of the module 7 3 2 Set Pump Rate You can set patient Pump Rate to either 100 mL min or 70 mL min The pump rate toleran...

Page 97: ...o ON or OFF in either BTPS or ATPD 7 3 5 Restore Defaults Push the Menu key Select System and then CO2 Select Defaults to restore all menu options to the factory default configurations 7 3 6 Set CO2 W...

Page 98: ...line 7 6 Zero the Sensor Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the measurement so as to ensure measurement accuracy For CO2 module a zero calibration...

Page 99: ...ush and hold the Exp Hold key The ventilator starts the Expiration Hold function and the screen shows Exp Hold Active Release the Exp Hold key The ventilator terminates the Expiration Hold function Ex...

Page 100: ...onds to Insp Hold key pressing operation only in non standby status Inspiration Hold function is disabled in CPAP mode and is supported when apnea ventilation occurs 8 4 Nebulizer During nebulization...

Page 101: ...initiated already 8 6 Suction The ventilator provides a suction procedure to help the patient to complete suction 1 Push the Menu key and select Procedure 2 Select Suction to access the suction proce...

Page 102: ...ormed on P0 1 measurement screen within three minutes the measurement screen exits automatically 8 8 NIF NIF is the maximum negative pressure generated by the patient s spontaneous breathing within a...

Page 103: ...a are frozen automatically 8 10 P V Tool Mechanical ventilation set with the optimal PEEP can improve oxygenation improve alveolar mechanics and reduce injury to the lungs By drawing static pressure v...

Page 104: ...w Time Time PEEP Pmax PEEP adjusted to Pstart Exp time Gas delivered at constant flow Expiration at constant flow The typical static P V loop is as shown below Volume Pressure 0 Lower turning point in...

Page 105: ...Procedure and set Pstart Flow Pmax and Vlimit parameters on the Procedure screen The system acquires Tmax parameter value based on the calculation formula and displays it on the menu screen Flow gas...

Page 106: ...l knob to determine the characteristic points The system also displays the volume value and pressure value of the inspiration and expiration branches corresponding to the cursor position and displays...

Page 107: ...ree categories physiological alarms technical alarms and prompt messages 1 Physiological alarms Physiological alarms also called patient status alarms are triggered by a monitored parameter value that...

Page 108: ...e treatment may be required The level for all technical alarms and physiological alarms are preset before the ventilator leaves the factory and are not user adjustable 9 4 Alarm Indicators When an ala...

Page 109: ...ill appear in the ventilator s alarm message filed The alarm message uses a different background color to match the alarm level High level alarms red Medium level alarms yellow Low level alarms yellow...

Page 110: ...ue ranging from 1 to 10 The value 1 is for the lowest and 10 for the loudest WARNING Do not rely exclusively on the audible alarm system when using the ventilator Adjustment of alarm volume to a low l...

Page 111: ...rk normally except audible alarm tones When alarm is silenced if a new technical or physiological alarm occurs the current alarm silenced status ends automatically and audible alarm tones are restored...

Page 112: ...an alarm which meets the user set requirements occurs The nurse call function is activated only when 1 The nurse call function is switched on 2 An alarm which meets the user set requirements occurs 3...

Page 113: ...y 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 clinical condition Use the specifi...

Page 114: ...cmH2O 3 Press the test lung in the inspiratory phase 4 Check if Paw Too High alarm is triggered if the ventilation cycle enters inspiratory phase and if airway pressure is reduced to the value of PEEP...

Page 115: ...to the ventilator 2 Connect the test lung to the ventilator and set the oxygen concentration to 40 Start the ventilation 3 After the ventilation is stable disconnect the high pressure air supply 4 Af...

Page 116: ...ation of the standard gas 4 Check if EtCO2 Too Low alarm is triggered 9 12 Alarm Logbook For alarm logbook the system provides up to 500 events which are stored in chronological order When a new event...

Page 117: ...he patient s condition 2 Determine the alarming parameter or alarm category 3 Identify the alarm source 4 Take proper actions to eliminate the alarm condition 5 Make sure the alarm condition is correc...

Page 118: ...9 12 FOR YOUR NOTES...

Page 119: ...leak and compromise normal system use Seeping liquid into the control assembly can damage the equipment or cause personal injury When cleaning the housing make sure that no liquid flows into the contr...

Page 120: ...parts to parts You need to select the appropriate method to clean and disinfect the parts based on the actual situations to avoid cross contamination between the ventilator user and the patient This t...

Page 121: ...iency detergent alcohol or isopropyl alcohol etc and then wipe off the remaining detergent with a dry lint free cloth B Immersion immersed in medium or high efficiency detergent alcohol or isopropyl a...

Page 122: ...alve assembly To disassemble the expiration valve assembly Push the expiration valve locker knob toward the inspiratory port and then pull out the expiration valve assembly with force To install the e...

Page 123: ...ate the expiration valve cover assembly to remove it from the expiration valve assembly To install the expiration valve cover assembly Insert the expiration valve cover assembly into the expiration va...

Page 124: ...hing hose B Water trap on the expiration valve assembly To disassemble the water trap Rotate the water trap gently to take it out To install the water trap Rotate to push in the water trap upward Ensu...

Page 125: ...ses one by one To install the breathing hoses 1 Mount the filters onto the inspiratory and expiratory ports 2 Connect the inspiratory filter to the water trap via the hose Connect the other end of the...

Page 126: ...ction 2 Pull out the nebulizer from the inspiratory hose To install the nebulizer 1 Connect one end of the nebulizer hose to the nebulizer connector and the other end of the hose to the nebulizer 2 Mo...

Page 127: ...ws can create significant errors in tidal volume and oxygen mix 10 2 6 Humidifier Note Install the humidifier which complies with the specification The humidifier assembly and its installation steps d...

Page 128: ...ifier sliding wheel with the humidifier bracket fixed seat and slide in the humidifier 2 Tighten the screw 3 Mount the filters onto the inspiratory and expiratory ports 4 Connect the inspiratory filte...

Page 129: ...fixing block C Fixing block D Humidifier sliding wheel E Humidifier bracket fixed seat F Screw G Beam To disassemble the humidifier 1 Remove the hoses connected to the humidifier 2 Remove the screws 3...

Page 130: ...rough 7 in 10 2 6 1 WARNING When installing the humidifier make sure that the humidifier connector shall be lower than the ventilator s breathing connectors and the patient 10 2 7 O2 Sensor A O2 senso...

Page 131: ...resentative Replacement and maintenance of the parts listed in this manual may be undertaken by a competent trained individual having experience in the repair of devices of this nature After repair te...

Page 132: ...e filter water trap at the Air gas supply inlet drain the water manually If there is water build up rotate the black handle at the bottom of the filer water trap gently clockwise or counterclockwise T...

Page 133: ...sor performance meets the technical requirements at least within one year Replace the expiratory flow sensor if it is damaged Replace the expiration valve if it is damaged Calibrate the touch screen i...

Page 134: ...g to close the breathing circuit 3 Push the Menu key Select Calibrate and select Flow Select Calibrate on the right side to start flow sensor calibration The message Calibrating is displayed 4 During...

Page 135: ...ion The message Calibrating is displayed 3 During the calibration if you select Stop the ongoing calibration will stop and the message Calibration Stopped Calibration is unfinished is displayed 4 Afte...

Page 136: ...ect the gas cylinder to the sampling line via a T shape connector as shown below Check the airway and make sure that there are no leaks 4 Vent the sampling line to the CO2 opening the cylinder pressur...

Page 137: ...t and how long it is used For a properly maintained and stored lithium battery its life expectancy is approximately 3 years For more aggressive use models life expectancy can be shortened We recommend...

Page 138: ...internal battery is limited If the battery capacity is too low power supply failure will occur and a high level alarm Low Battery Voltage will be triggered In this case apply AC power to the ventilato...

Page 139: ...he batteries uninterruptedly for at least 10 hours 3 Disconnect the AC power source Allow the ventilator to operate on battery power until the ventilator shuts off 4 Re connect the ventilator to the A...

Page 140: ...y in compliance with the local laws regulating the disposal of such product WARNING Do not disassemble batteries dispose of them in fire or short circuit them They may ignite explode leak causing pers...

Page 141: ...rotective earth terminal of the AC power cord into the protective earth contact of the power outlet Repeat steps a to d 2 Connect the compressor if configured to the auxiliary electrical outlet 3 Perf...

Page 142: ...or unstable tidal volume fluctuation is detected Check the sensor for water If there is water build up clear it before use To prevent water build up solutions are 1 Water condensation in the flow sen...

Page 143: ...omply with the biocompatibility requirement of ISO10993 1 to prevent any adverse reactions arising from such contact Disposal of the accessories shall comply with the applicable waste control regulati...

Page 144: ...ild 600mm 082 000556 00 SAINT GOBA IN Silicone breathing tube Child 450mm 082 000557 00 Y type connector Reusable Y type connector child 040 000740 00 VADI straight connector Reusable straight connect...

Page 145: ...040 000819 00 GALEMED New Sil Flex Silicone Mask 3 Child Large 22F 040 000820 00 GALEMED Sil Flex Silicone Face Mask 2 Child 040 000821 00 GALEMED Inflatable anesthesia mask Adult Large M6Q 150013 GAL...

Page 146: ...ing tube 115 004513 00 Fisher Paykel Humidifier MR810 230V ad ult tube 115 004515 00 Fisher Paykel Humidifier MR810 115V ad ult tube 115 004516 00 Fisher Paykel Gas supply tube assembly O2 Air Air tub...

Page 147: ...A 1 A Theory of Operation A 1 Pneumatic System A 1 1 Pneumatic Circuit Diagram Patient O2 Inlet Air Inlet Atmosphere PEEP valve Humidifier Nebulizer...

Page 148: ...sensor SOL3 Three way valve for Air O2 connection selection OS O2 sensor NCV Nebulizer control valve SV Inspiratory safety valve Nebulizer Nebulizer legally launched RV1 Pressure relief valve 10 cmH2...

Page 149: ...ry flow Dust filter F3 F4 is placed before flow sensor to stabilize gas flow facilitating measurement by sensor Flow sensor Q1 Q2 is hot wire flow sensor for accurate measurement of gas passing throug...

Page 150: ...the front end of PEEP is used to stabilize pressure to prevent change of valve closing pressure caused by change of PEEP front end pressure SOL3 is a three way valve for Air O2 connection selection A...

Page 151: ...he expired gas from condensation which compromises the measurement accuracy Expiratory flow sensor Q3 is a flow sensor based on the principle of differential pressure Diaphragm type sensor is characte...

Page 152: ...A 6 A 2 Electrical System A 2 1 Electrical Block Diagram 16 17 27 18 19 20 10 9 11 15 12 21 22 25 30 29 28 23 24 26 1 2 7 3 6 4 5 13 14 8...

Page 153: ...al outlet 1 22 Inverter 8 Main unit AC power socket and fuse 23 Key scan board right 9 AC DC power board 24 Rotary encoder 10 DC DC power board 25 Speaker 11 Fan 26 Alarm lamp board 12 Inspiratory mod...

Page 154: ...A 8 FOR YOUR NOTES...

Page 155: ...gainst electric shock Class I equipment with internal electrical power supply Where the integrity of the external protective earth ground in the installation or its conductors is in doubt the equipmen...

Page 156: ...ply Output voltage 220 to 240 V 100 to 120 V Output frequency 50 60 Hz 50 60 Hz Output current outlet 1 3 0A 6 0A Output current outlet 2 3 0A 3 5A Output current outlet 3 3 0A 3 5A Fuse outlet 1 T5AH...

Page 157: ...ms occur simultaneously it flashes red only AC power LED One green lit when connected to the AC power supply Battery LED One green lit when batteries are installed and AC power supply is connected fla...

Page 158: ...ndards Air H2O 7g m3 oil 0 5g m3 O2 H2O 20g m3 Dew point of the compressed air lower than room temperature by 5 in case of 30 L min flow Fresh gas Fresh gas is called after supplied Air and O2 are mix...

Page 159: ...mL min 20cmH2O B 6 Ventilator Specifications Controlled parameters Parameter Range Step Unit O2 21 to 100 1 TV Pediatric 20 to 300 Adult 100 to 2000 Pediatric 1 Adult 10 mL f Pediatric 1 to 150 Adult...

Page 160: ...00 Adult 1 to 100 1 bpm Weight Pediatric 3 to 35 0 5 kg Adult 10 to 200 1 kg Monitored parameters Parameter Range Resolution Unit Ppeak 20 to 120 1 cmH2O Pplat Pmean PEEP 0 to 120 1 cmH2O TVi 0 to 400...

Page 161: ...er PEEP 2 0 cmH2O or 10 of setting whichever is greater Pinsp 2 0 cmH2O or 10 of setting whichever is greater Psupp 2 0 cmH2O or 10 of setting whichever is greater Phigh 2 0 cmH2O or 10 of setting whi...

Page 162: ...to 1000 20 1 min L or 15 of the displayed value whichever is greater Other range not defined WOB No declaration NIF 2 cmH2O 4 of the actual reading P0 1 2 cmH2O 4 of the actual reading PEEPi No decla...

Page 163: ...lt 0 1 to 50 0 L min OFF NIV 0 5 MV monitored value Paw High limit 10 to 105 cmH2O Average peak pressure 10cmH2O and 35cmH2O whichever is greater ftot High limit 1 to 160 OFF 1 4 ftot monitored value...

Page 164: ...ion Suction lasts for a maximum of 120s When patient reconnection is detected the system enters next phase automatically Phase 3 O2 after suction Delivering 100 O2 lasts for a maximum of 120s O2 conce...

Page 165: ...sured by using adult water trap and 2 5 meter long adult sampling line Total system response time 3 5s 100mL min 4s 70mL min Measured by using neonatal water trap and 2 5 meter long neonatal sampling...

Page 166: ...ions O2 sensor Output 9 to13 mV at 210 hPa O2 Range 0 to 1500hPa O2 100 O2 signal deviation 100 1 Resolution 1 hPa O2 Expected service life 1 5 x 106 for measurement 20 C 0 8 x 106 for measurement 40...

Page 167: ...ory of Operation O2 sensor can monitor the patient s FiO2 O2 sensor is of the self powered diffusion limited metal air battery type comprising an anode electrolyte diffusion barrier and air cathode as...

Page 168: ...h affect the O2 partial pressure will correspondingly alter the output signal of the sensor Pressure Effects Since the sensor measures O2 partial pressure the output will rise and fall due to pressure...

Page 169: ...B 15 Temperature C Life 1192 exp 2 0 0239 Temperature Life of 20 C Figure...

Page 170: ...B 16 FOR YOUR NOTES...

Page 171: ...acent to or stacked with other equipment If adjacent or stacked use is necessary the ventilator or its components should be observed to verify normal operation in the configuration in which it will be...

Page 172: ...Group 1 The SynoVent E5 ventilator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF...

Page 173: ...line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions an...

Page 174: ...lated from the equation appropriate for the frequency of the transmitter Recommended separation distances Conducted RF IEC61000 4 6 3 Vrms 150 kHz to 80 MHz Outside ISM bandsa 3 Vrms P d 2 1 10 Vrms 1...

Page 175: ...tional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges c Field strengths from fixed transmitte...

Page 176: ...3 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation app...

Page 177: ...pired O2 concentration is higher than the FiO2 high alarm limit for at least 20s Check the Air supply and calibrate the O2 sensor FiO2 Too Low H The inspired O2 concentration is lower than the FiO2 lo...

Page 178: ...M FiCO2 Too High M D 2 Technical Alarm Messages Source Alarm message P Cause and action System Low Battery Voltage M Battery voltage is lower than the threshold value Connect AC power supply immediate...

Page 179: ...e card Insp Hold Interrupted L This alarm is triggered when the Insp Hold key is pressed and held longer than the time limit The alarm is cancelled when the Insp Hold key is released Exp Hold Interrup...

Page 180: ...lation setting parameters to see if the ventilation volume is too large Check if the supply gases are normal Check if the expiratory flow sensor has a deviation and perform zero calibration Check the...

Page 181: ...nsor Please calibrate O2 sensor L Calibrate the O2 sensor Please perform flow calibration H Calibrate the flow sensor Please perform pressure calibration H Calibrate pressure Air Insp Limb Failure H T...

Page 182: ...ftware s sending parameter configuration to protection module is failed Restart the ventilator If the problem persists contact your service personnel CO2 module CO2 Init Error H An error occurs during...

Page 183: ...Attempt to restart the ventilator CO2 Hardware Error H Errors may occur to 1 External A D sampling 2 5V 2 12V power supply voltage 3 Internal A D sampling 2 5V 4 Pump 5 3 way valve Restart the ventil...

Page 184: ...D 8 FOR YOUR NOTES...

Page 185: ...orking mode Measure Pump rate 100 mL min Humidity compensation OFF CO2 calibration concentration setting 3 EtCO2 low limit Adult 15 mmHg Pediatric 20 mmHg EtCO2 high limit Adult pediatric 50 mmHg FiCO...

Page 186: ...int PEEP OFF Sigh OFF Tinsp Adult 1 7s pediatric 0 7s I E 1 2 Assist ON F Trig Adult 2 0 L min pediatric 1 0 L min Flow Adult 20 L min pediatric 8 L min f Adult 12 bpm pediatric 29 bpm ATRC only in no...

Page 187: ...ompensation proportion only in non NIV mode 80 Compensation of expiration only in non NIV mode ON V SIMV TV Adult 7 kg mL x IBW and 100 ml whichever is greater pediatric 7 kg mL x IBW round down when...

Page 188: ...n pediatric 1 0 L min Exp Auto fapnea Adult 12 bpm pediatric 29 bpm Apnea ventilation ON ATRC only in non NIV mode OFF Tube diameter only in non NIV mode 8 0mm Compensation proportion only in non NIV...

Page 189: ...igh 15 cmH2O Plow 5 cmH2O Thigh Adult 1 7s pediatric 0 7s Tlow Adult 3 3s pediatric 1 4s F Trig Adult 2 0 L min pediatric 1 0 L min Exp Auto Papnea 15 cmH2O fapnea Adult 12 bpm pediatric 29 bpm ATRC o...

Page 190: ...cmH2O fapnea Adult 12 bpm pediatric 29 bpm ATRC only in non NIV mode OFF Tube diameter only in non NIV mode 8 0mm Compensation proportion only in non NIV mode 80 Compensation of expiration only in no...

Page 191: ...m centimeter cmH2O centimeter of water dB decibel fahrenheit g gram hr hour Hz hertz hPa hectopascal inch inch k kilo kg kilogram kPa kilopascal L litre lb pound m meter mAh milliampere hour mbar mill...

Page 192: ...million s second V volt VA volt ampere ohm A microampere V microvolt W watt minus percent per divide or to power plus equal to less than greater than less than or equal to greater than or equal to plu...

Page 193: ...ed Oxygen Concentration Flow Flow f Breathing Frequency fapnea Frequency of Apnea Ventilation fmand Mandatory Frequency fspn Spontaneous Frequency fSIMV Frequency of SIMV ftot Total Breathing Frequenc...

Page 194: ...ation Resistance Rexp Expiration Resistance Sigh Sigh SIMV Synchronized Intermittent Mandatory Ventilation Texp Time of Expiration Thigh Time of High Pressure Tinsp Time of Inspiration Tlow Time of Lo...

Page 195: ......

Page 196: ...P N 046 000991 00 10 0...

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