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User`s Manual MV2000[SU:M] Ventilator System 0470

1. 1 Alarm Silence 2 min 2 Alarm Reset MV2000 SU M Ventilator 7 Alarm 7 2 3 Pausing Alarm Sound If Alarm Silence button is pushed among fixed keys at the bottom of the monitor Current alarms become silenced or muted for two minutes Bell icon appears on the message window with remaining time for mute Sound is muted for two minutes every time Alarm Silence button is pushed 7 2 4 Alarm Sound Volume Control Sound Val Alida Arn 1 Select System button among menu buttons located at the bottom of user interface 2 Select Setup in the System Menu 3 Activate sound volume by touching Sound Vol Adjust the volume of alarm sound Once adjustment is complete touch again to deactivate the window 50 MEKICS Co Ltd 7 3 Alarm Setting This Section explains alarm screen display alarm setting 7 3 1 Alarm Screen Display 307 Configured alarms values are displayed on the left side of the screen and in measurement value window at the bottom Among displayed alarm values value above is the upper limit and value below is the lower limit 7 3 2 Alarm Setting Select Alarms among menu at the bottom of the screen when configuring alarm values A new menu called Alarm Set appears This menu can be used to configure alarms VE TIDAL HIGH OFF OFF mL 10 5 2500 0 m VE TIDAL LOW VE MIN HIGH VE MIN LOW R RESP HIGH R RESP LOW P PEAK HIGH P PEAK LOW Taw
2. Appendix 2 6 EtCO2 Module Cleaning MV2000 SU M Ventilator Annex 2 Cleaning Sterilization Sterilization Clean and sterilize after using on a patient or dispose according to the hospital s policy DISINFECTANT CLEANING WASHING CLEANING DRYING DISINFECTANT WASHING HEATING STERILIZATION Appendix 2 6 1 Preparation Separate EtCO gt from the ventilator Appendix 2 6 2 EtCO2 Module Body Wipe the main body using soft cloth with disinfectant Cidex OPA or isopropyl alcohol 70 80 MEKICS Co Ltd After cleaning and sterilization wipe the module using soft cloth soaked in water Module must be dried after cleaning and sterilization Appendix 2 6 3 Airway Adapter Airway adapter can be disinfected or sterilized ATTENTION Do not place EtCO2 module in solutions like water Place airway adapter in Cidex OPA solution during sterilization Clean airway adapter using distilled water Airway adapter must be dried and wiped before re using AN ATTENTION Follow recommendations and guidelines of the manufacturer on the use of disinfectants Airway adapter for adults can be sterilized for 4 7 minutes at 134 C 273 F in accordance to sterilization regulation of each hospital After sterilization process adapter must be dried prior to use MV2000 SU M Ventilator Annex 2 Cleaning Sterilization Appendix 2 7 Accessories MEKI
3. TA If there is a problem in commercial power or patient must be transported while the product is in operation battery must be charged Replace the battery if it is considered inadequate If voltage is inappropriate measurement value may result in errors If battery is low connect to commercial power In case of abnormality in battery contact Sales Customer Service to receive necessary service Appendix 3 3 Accessories 82 MV2000 SU M Ventilator MEKICS Co Ltd Fischer amp Paykel Humidifier MR850 of Fischer amp Paykel Humidifier for details on cleaning and sterilization Refer to User Manual methods Appendix 3 4 Warranty Period This product was manufactured based on strict quality management and testing process of our company Compensation criteria for product repair and replacement are as announced in Consumer Injury Compensation Rule by the Economic Planning Board Warranty period for this product is regulated as one year since installation However warranty period for LCD battery and O2 sensor is six months If the product shows defects under normal use during warranty period our customer service team will repair defects free of charge during warranty period Prescribed service fees are levied after repair in the following cases m Defect from natural disasters such as fire earthquake and lightning m Defect from inappropriate movement or carelessness in use
4. EtCO2 Zeroing EtCO2 Module 4 9 1 Flow Zeroing Flow zeroing is an automatic offset adjustment function on inspiratory and expiratory flow sensor Calibration starts by pushing Start button after rotating the encoder Calibration is completed after a moment 4 9 2 Expiratory Flow Gain Adjust expiration flow Ratio of inspiration volume to the balance of inspiration flow and expiration volume can be adjusted If you 21 MEKICS Co Ltd expiratory flow gain value increase expiratory measured value is increased 4 9 3 Adult Neonatal Gain Proximal Flow Adjust the balance of inspiration and proximal flow Connect proximal sensor to inspiratory outlet port and select menu will start the calibration Calibration is completed after a moment 4 9 4 O gt Cell Calibration O2 cell may show incorrect O concentration due to natural consumption of O cell with longer use Therefore O2 concentration can be fixed through calibration With air supply connected rotate the encoder and select 21 menu to start with 21 O calibration Calibration is completed after a moment While 100 02 is being supplied 100 O calibration can be started by rotating the encoder 100 completed after a moment and selecting menu Calibration is DS note If 02 cell has been expired replace the cell before performing calibration 4 9 5 Leakage Test Analysis of leakage and compliance is conducted First directly co
5. Connection Label Symbol ronnrnrrvrrvrnrrvrnvrvsrvenvrnsrversrvsrnersensenersessrversenervensersnvensene 7 2 2 1 User Interface Configuration n rrsnrnvvrssrvesvrssrsersrsrrsersesrsersererversersrversessrvessessrsessesersensensssessenessessenensenee 8 UTD 9 LE User ON reais rara aE Eana S aN E T AARONA 10 2 3 User NEVE 10 TT NS 10 I TN 11 LE GAGE 11 2 NENNE 12 SE EEE 12 2 3 6 Status System Information Window Lunsssepsesnsegnsadnsmesnsimbndmbndnbniti nb 13 MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents 2 4 Patient Unit Connection Label Symbol nrnnrvrnrrvrnrvrnsrvrnsrvrnsrnensrnensrvensrnensrnersrnensenersenersenersennenn 13 TIP 13 LOE E S 90 EN NN RER VER PER FER EEREERER 14 2 5 Transportation and Storage in Hospitals onsrvrnrrvrnrrvrnrrvrnsrvrnsrnrnsrvensrvensrnersrnensenensenensenensenersenersenenenn 14 25 1 Prior TT 14 2 5 2 During TransportatiOn sr rsvvnssressrsssessrsesesesersesrsesseseseesrserseseserserersrsersssenessrsenensrsensssrsesessenensnee 15 2 5 3 Transportation Between HospitalsS rsnrrvnnvrsvrsesrsesrsersrsersrsersrsersrserserersesersensrsenersessrsersrsessnsessnsene 15 FASE SKS Ea 8 E E E E E E AE E E ET 15 3 Power NNN 16 TONE 16 3 1 1 Power Supply Specification n snrsrnvvrssrversrserversrsreverseserverserrrverserervessessrsensenssvensenersessessssessesessensenesssnee 16 3 1 2 Battery Information SUMMALY sersrrrrvervrvsr
6. 10 Initial Screen Configuration 10 3 System Setting System menu is composed of Setup menu that configures operating conditions of the ventilator Patient menu that configures patient information Date menu that decides date and time and menu that various Calibration configures calibrations 10 3 1 Setup The following parameters are configured in Setup menu 1 BWF Configure air volume mL per Kg of the patient s body weight B W Range 5 15 mL kg 2 Nebulizer Time Configure usage time of nebulizer Range 10 180 min 3 O2 Sensor Configure the use of 02 cell whether to enable or disable the sensor Enable 02 gas is used when 02 cell is normal Disable This is when there is no 02 gas lifespan of O2 cell has expired or O2 cell can not be used for a different reason There is no influence on supply of O gt gas 4 Trend Init 60 MEKICS Co Ltd 10 Initial Screen Configuration Initialize trend data 10 3 2 Patient 5 BTPS BTPS is an abbreviation of Body Temperature and Pressure Saturated with Water Vapor and refers to the state in which physical factors that influence air volume inside body are taken into consideration This function compensates for volume of air supplied considering difference between body temperature and external temperature with altitude above sea level Patient information is entered in Patient menu Range OFF BTPS function is turned
7. 3 3 Alarm and Safety Devices using battery Battery status is always monitored by the ventilator Check the following precautions 3 3 1 Warnings Check the battery prior to use for safe battery backup operation If low battery is displayed battery must be quickly replaced 17 MV2000 SU M Ventilator MEKICS Co Ltd 4 Operation Method 4 1 Operation Sequence Summary The following is summarized operation sequence of MV2000 SU M ventilator 1 Check of pre use 2 Select the patient type 3 Input patient information in the system menu 4 Select ventilation mode 5 Configure parameters for the selected ventilation mode 6 If necessary check and adjust alarm range in the alarm menu 7 Connect the ventilator to the patient and push Accept button in ventilation mode to start ventilation 8 During ventilation user can make or change the settings as below 9 Parameter setting can be seen or changed using direct access button detailed description on individual sequence of ventilator Refer to the following section for operation 4 2 Pre Use Check Test and measurement items during pre use check process are as follows Gas supply status System function inspection Internal block leakage Pressure sensor Flow sensor Q2 cell Battery status Leakage and compliance of patient tube MV2000 SU M Ventilator 4 Operation Method AN WARNING Always perform pre
8. after the preset pause time LE ratio is determined by items that influence inspiratory time and by respiratory rate When changing setting values of LE ratio or items that influence inspiratory time breath timing bar is displayed to show changes in cycle time inspiratory time expiratory time and LE ratio 6 5 P ACV Pressure Controlled Ventilation Pressure control mode uses mechanical ventilation method PACV is a ventilation of the patient based on pressure mode that controls mechanical Pressure TRIG PEEP cmH20 RESP R BPM TRIGGER TYPE PINSP cmH20 15 TRISE sec 0 5 EnSENS 2 The following parameters are configured in PACV mode MV2000 SU M Ventilator 6 Ventilation Mode and Function Inspiration Pressure cmH gt 0 Inspiration Time sec Respiratory Rate b min PEEP cmH gt 20 Oxygen Concentration Inspiration Rise Time sec Inspiratory Trigger Sensitivity Trigger Flow Trigger Pressure O 0 Oo Uur ww oNN P Trigger Setting Ipm cmH20 10 Mask Mode On Off The delivered volume is dependent upon the pressure above PEEP lung compliance and resistance in the patient tube system and airways This means that the Tidal Volume can vary As the delivered tidal volume can vary it is very important to set alarm limits for Minute Volume to adequate levels When pressure control ventilation is provided by mandatory breath in assist control mode inspiratory pressure
9. pressure limit Pressure Limit BD EE ER ee ee Time Flow Inspiratory Peak Flow Time 6 16 TCPL SIMV Time Cycled Pressure Limited Synchronized Intermittent Mandatory Ventilation TCPL SIMV mode is similar to one the TCPL AC mode and the mode assist the patient s spontaneous breathing TCPL SIMV Pressure TRIG PEEP cmH20 RESP R BPH TRIGGER TYPE PINSP cmH20 30 PSUPP cmH20 60 0 5 80 0 0 1 10 APHEA sec TRISE PS sec EnSENS 2 MV2000 SU M Ventilator 6 Ventilation Mode and Function The following parameters are configured in TCPL SIMV mode Flow lpm Respiratory Rate b min PEEP cmH gt 20 Oxygen Concentration Inspiratory Pressure cmH gt 0 Inspiratory Time sec Inspiratory Trigger Sensitivity Expiratory Trigger Sensitivity O p N ae PP YS Pe Trigger Flow Trigger Pressure ar O Trigger Setting lpm cmH gt 0 Im Pressure Support cmH gt 0 m NO Trise Pressure Support cmH gt 0 MM OJ Apnea sec Mask Mode On Off 4 IS 6 17 Ventilation Parameter Outline When ventilation mode is selected parameters related to the configured ventilation mode are displayed on the screen The following parameters are related to all ventilation modes 1 Respiratory Rate RR Respiratory rate is used to calculate the number of mechanical respirations or target volume b min 2 Tidal Volume VT Volume per respiration or
10. Equipotentiality This symbol indicates terminal that does not require ground potential for connecting system parts to create equipotentiality IEC601 1 IEC 417 5021 Attention Consult accompanying documents This symbol indicates that user must consult accompanying document User Manual prior to operation IEC 601 1 EXT BATT This symbol indicates external battery for vehicles This symbol indicates external power AC connection part IEC 417 5534Pr Monitor Connector This symbol indicates connection to user interface and cable RS232 Serial Port This symbol indicates data communication connection Heater Heater heats the exp part during ventilation to prevent moisture Be careful about high temperature heat 2 5 Transportation and Storage in Hospitals 2 5 1 Prior to Transportation Check the following matters before transporting the ventilator whether the ventilator is connected to a patient or not 14 MV2000 SU M Ventilator MEKICS Co Ltd Check whether patient unit and user interface are firmly fixed and locked Check whether accessories such as modules and humidifier are firmly fixed Check the connection of gas container and amount of gas in the container Check whether battery is sufficiently charged Check whether the ventilator operates properly Check for damages in the mobile cart If medical portable compressor MC200 is used make sure i
11. MV2000 SU M Ventilator MEKICS Co Ltd 1 Introduction 1 1 Device Outline This chapter provides guidelines for correct use of the product and summarized information on the MV2000 SU M ventilator system 1 1 1 Device Illustration 1 1 2 Device Configuration MV2000 SU M ventilator is composed of the following 1 User Interface Configures ventilation mode and displays patient measurement data with alarms 2 Main Mixes supplied gas Delivers and exchanges gas 1 1 3 Use MV2000 SU M ventilator is a device designed to treat and monitor insufficient ventilation or patients suffering respiratory insufficiency 1 1 4 User MV2000 SU M ventilator must be used by the following users MV2000 SU M Ventilator 1 Introduction Medical professionals Individuals who received training on the use of this device Individuals who have experience in treatment of respiratory diseases 1 1 5 Environment MV2000 SU M ventilator must be used in the following environments Hospitals Facilities and institutions with the purpose of providing medical service Transportation of patients within hospitals or medical institutions 1 1 6 Service Guideline AN CAUTION Regular Inspection MV2000 SU M ventilator must be regularly inspected by a trained professional Inspection Record All matters related to inspection of MV2000 SU M ventilator shall be recorded in accordance to regulations
12. Trigger Flow Trigger Pressure Trigger Setting lpm cmH20 EE DE YP Pressure Support cmH gt 0 ar Upper Pressure Support cmH20 Inspiration Rise Time sec m N Rise time in Pressure support sec Mask Mode On Off OJ tBILEVEL mode is a mixed mode in which both mandatory breath and spontaneous breath can Occur Though it is similar to SIMV mode in that it is a mixed mode it differs from SIMV in that there is no spontaneous section That is spontaneous breath can occur at any time Two levels of PEEP are provided to the patient in tBILEVEL mode High level PEEP is called PEEPuich and low level PEEP is called PEEP ow Inspiration of mandatory breath is when PEEP ow is converted to PEEPyGH Expiration is when PEEPuich is converted to PEEP ow 41 MEKICS Co Ltd Therefore all mandatory breaths in tBILEVEL mode are pressure control ventilation The Transition interval is short time in before and after of each transition period In this interval if the patient intends to breath the transition time can be quickened or slowed according to the breathing pattern Setting items include respiratory rate PEEPkGH and PEEPiow Support pressure is additionally configured using pressure support ventilation ret er Synchronized Transitions Spontaneous Breaths It is possible to synchronize the transition from PEEPHigy to PEEP ow with the patient s respiratory cycle Also at PEEP
13. appropriate setting according to patient condition and clinician s decision SHFqV Made Pressure amp Flow eee etal tfelat lett tant According to the patient lung you select the MAP If you increase the amplitude of the Pman and Pmin Paw should be greater than the amplitude of 1 2 Power doesn t have the unit and determine the minimum and maximum power When the power increases the amplitude of the pressure and flow rate is increased But the amplitude of the pressure increase if Paw is low the amplitude will be limited by Paw Flow Pressure TIME B Kg Power MAP cmH20 H Freq Hz 150 AN 100 3 1 The following parameters are configured in SHFV mode 1 Power 2 MAP cmH20 3 Frequency Range Hz 4 Oxygen Concentration 6 14 DHFV Ventilation Dual High Frequency 45 MEKICS Co Ltd Insufficient ventilation volume of SHFV mode can be supplemented intermittently using exhalation time During expiratory time it is available measuring EtCO2 ventilation of Single HFV Increasing CO exhalation at insufficient eat il Flow Pressure TIME B Kg Power MAP cmH20 RESP R BPH 150 AN 100 60 27 3 1 5 2 02 H Freq Hz 100 l 20 20 21 2 IHY Etime sec 3 5 0 3 The following parameters are configured in DHFV mode 1 Power 2 MAP cmH20 3 Respiratory Rate b min 4 Frequency Range Hz 5 IMV time sec 6 Oxygen Concentration 6 15 TCPL AC Time Cycled P
14. 1 sec Pause Time PEEP 0 45 cmH20O 3 cmH20 High PEEP t Bilevel 3 45 cmH O 10 cmH gt 0 Low PEEP t Bilevel 0 42 cmH20O 3 cmH O Inspiratory Pressure limit PRVC O gt 10 80 cmH gt 0 StreamQ Minute Volume AutoVent 70 300 Inspiratory Flow rate 02 Stream 5 40 Ipm Enable inhalation trigger En sense 10 80 30 Exhalation trigger Sensitivity Ex trig 10 80 30 F end 25 100 70 Inspiratory Rising Time 0 1 0 5 sec 0 2 sec Inspiratory Rising Time PSV 0 1 0 5 sec 0 2 sec ud OFF Trigger sensitivity Pressure 3 cmH20 0 5 20 cmH gt 20 Tri itivity FI oe 3 rigger sensitivi Ow m oe x 0 5 20 L min i O2 21 100 30 Sigh Tidal volume Off 30 60 90 120 BTPS OFF Auto Dry Auto Humid MASK ON OFF Proximal Sensor ON OFF Power Single Dual High Frequenc i E ge 2 J 1 100 Ventilation MAP Single Dual High Frequenc i oe i i 5 60 cmH gt O 20 cmH gt 0 Ventilation Frequency Single Dual High Frequenc i cyl if ig 2 20 Hz 20 Hz Ventilation IMV Ex duration Dual High Frequency 0 3 6 0 sec 2 0 sec Ventilation ExRate Dual High Frequency Ventilation 2 120 bpm 12 bpm Setting range Default 68 MV2000 SU M Ventilator MEKICS Co Ltd 11 Technical Specification Nebulizer 10 180min Off Measures lung compliance Inspiration pause resistance elasticity Time constant Expiration pause Measures auto PEEP Manual Inspiration Delivers one mandatory breath 100 O Del
15. Breathing is found in prescribed respiration per minute Medical staff manages the patient three values including MinVol PEEP and O2 This guideline includes weaning induction using If self breathing of the patient is strong operation is conducted as Spont PS 5cmH20 minimum 10 seconds apnea time The patient s respiration is reduced or non breathing over 10 seconds is automatically controlled Advantages and limitations of AutoVent mode are as follows 1 Advantages 1 Patient is managed without transition between CMV SIMV and Spont modes MV2000 SU M Ventilator 2 3 6 Ventilation Mode and Function Convenience of mode management and simplification of patient information can be accomplished Since minute volume is guaranteed without risks in weaning induction such as non breathing this mode is relatively safe against non breathing Based on monitoring result on gas concentration in blood and respiration gas concentration of the patient relatively stable patient management is made possible through simplified algorithm for Vmin PEEP and O2 concentration 2 Limitations 1 2 3 4 Since this mode includes a completely different concept than existing modes training on the new method is required There is a possibility of mistaking this mode as a universal mode with lack of training leading to inappropriate patient management Patient management is still required s
16. MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents 4 8 Change in Setting Parameter vr 21 4 9 Measurement Sensor Callbraton 2vvv4v22c44v4vvvvevvevrevvsrvvevenee 21 Fl NNN 21 JS Blur 21 4 9 3 Adult Neonatal Proximal Flow Gain ssrervrsrsvsrsssrsssessssssssesssssssseeeien 22 BF MENN 22 4 9 5 Leakage TesSt n nn nvmnvnvnvnvnvvnvvvnenesssesesersrseeseseeseseesrsersesseressesessenessesessesenee 22 JE NR 22 4 10 Separation of Ventilator from Patient onornrrvrnrrrrrvrrsrrrrvrnsrvsrversrvsrvensevsrvensensrvensersrnensenrsersenersenenn 22 5 Monitor and Information Saving u cccccccccsssssssesssssssesscsessesscsessessssessesscsessssucsessssucseesesucsessessseeseaeeseesee 23 5 1 Measurement Value Display ornrvrrrrvrrrrvrrrrvorrrrorsrvornrvervenrnrssrsensrnensrsensrvensnnensrnessnnensenensnnensrnessrnessenessensnee 23 5 1 1 Measurement Value SCreen m s rsssnssrsrsrsrrsrssesersrssesrrsrssesersrssesersrssesersrssessrsessessssessessssessssssseserssssene 23 5 1 2 Additional Measurement Display Screen mrrsvssnssnssnssssssssesssssseseen 23 5 1 3 List of Measurement and Calculation Values mmrvrvrsrsrsrssesessrsrsesresersersrssrssessesersersrsseseernns 24 5 2 Waveform Display c ccccccccccccscssessessssessesssessesscsessssucsessssussessesussesusssssesucsssesucsussesussesseaucseeseaueseeseaeeseeseaeeneens 25 PLN 25 5 2 2 Waveform Setting and Change msmmrnsrnsrvervrnsrvsrvensrssrs
17. a i du a a ee ee Se LL I I 1 1 P In order to adjust ventilation mode parameter 1 Activate by touching the wanted direct access button 2 Use the encoder to configure values 3 Touch again to deactivate AN NOTE When parameters are changed using direct access button changed values are applied since the next breath Here there is no button to confirm user s intentions such as Accept button on touch screen MV2000 SU M Ventilator 2 System Outline 2 3 5 Menu Key 6 menu keys are positioned on the bottom of user interface These keys can be touched for activation Description on each menu Is as follows 1 Monitoring Comprehensively displays data measured in each mode 2 Graphic Configures screen layout and trend timing Waveform Pressure Flow Volume Loop P V V F P F Trend VE MIN PMEAN PPEAK VTE CL RA 3 Tools Uses Insp Hold and Exp Hold functions 4 Events Events that occur during operation of the ventilator can be seen 5 System Composed of operating environment patient information input date change and various calibration settings 6 Alarms This menu is used to configure various alarms on measurement values 12 MEKICS Co Ltd 2 3 6 Status System Information Window MD Q C O User interface displays current status of the ventilator Types of status displayed are as follows 1 Current ven
18. changed in connection with monitoring menu MV2000 SU M Ventilator 5 Monitor and Information Saving 5 1 2 Additional Measurement Display Screen To see more measurement values 1 Touch the arrows pointing up and down on the bottom left corner of the screen 2 Measurement values can be seen up to a maximum of 12 pages 3 Check monitoring menu to see measurement values at once 23 MEKICS Co Ltd 5 Monitor and Information Saving 5 1 3 List of Measurement and Calculation Values Difference between measured PEEP and configured PEEP VEMIN L Expiratory volume per min in spontaneous breath SPONT DM ne __ inspiration to expiration aio Respiration through EtCO gt Expiratory CO gt Tidal Volume 24 MV2000 SU M Ventilator MEKICS Co Ltd 5 2 Waveform Display When SpOz and EtCO gt options are connected color wise waveforms are displayed on the screen as follows Up to four waveforms can be displayed on the screen Pressure vs time Flow vs Time Volume vs Time SpO gt vs Time EtCO gt vs Time 5 2 1 Characteristics Waveforms are displayed on the screen as follows Measured parameter values are displayed according to time axis Parameter and scale are displayed on Y axis Pressure vs time graph is displayed in dark pink Flow vs time graph is displayed in dark sky blue Volume vs time graph is displayed in white SpO gt vs time grap
19. must be changed and use the encoder to adjust their values After adjusting the parameter re select the parameter for deactivation or push the encoder to save the adjusted value 4 Once setting value is saved push Accept button to operate with saved value or push Cancel to cancel MV2000 SU M Ventilator 4 Operation Method 4 5 Alarm Setting Alarm Setting 1 Touch the alarms button on the bottom of user interface 2 Select alarm value to adjust 3 Rotate the encoder to change and modify the value 4 Touch the value again or push the encoder to save changes 5 Alarm configured using alarm auto button values can be automatically DS note Consider alarm auto function prior to application in a patient If auto function is alarms directly inappropriate configure Alarm auto function is configured based on the patient s body weight 4 6 Starting Ventilation As in 4 4 select ventilation mode configure parameters and touch Accept button to operate the ventilator If standby key is pushed during operation of the ventilator window pops up to ask whether to move to standby mode The ventilator converts to standby mode once Standby button is pushed Push X on the top right corner to cancel 4 7 Change in Patient Type MV2000 SU M ventilator can select among four patient type in standby mode Male Adult Female Adult Pediatric Neonate Infant 20 MEKICS Co Ltd ZS n
20. of the product after installation m Defect from repair or renovation made by an individual other than service agents designated by MEKICS Preparations for repair requests m If defect occurs immediately stop the use and check details on the defect in this manual m Before contacting our company s customer service team for repair request please check model name manufacture MV2000 SU M Ventilator Annex 3 Maintenance number purchase date and problem AS CAUTION If defect is caused by inappropriate handling or careless management of the product the manufacturer and its sales agencies are not responsible for any damages Please contact the following numbers and addresses to receive various services and products or to contact the Sales Department of our company Manufacturer Customer Service Team MEK ICS Co Ltd 144 3 Sangdaewon dong Jungwon gu Seongnam Gyeonggi Province 5F 5th Woorim Lions Valley Buliding A Sales 82 70 7119 2520 Customer Service 82 70 7119 2552 FAX 82 31 735 2761 Web site http www mek ics com E mail customer mek ics com We are also receiving customer complaints through MEK ICS web site If you experience any discomforts or improvements to be made on the product please feel free to contact our company or its customer service team at any time 83 MEKICS Co Ltd
21. standards Standards EN60601 1 1990 EN60601 1 1 2001 Electromechanical Safety EN60601 1 2 2001 Electromagnetic Compatibility Requirement and tests JEC60601 2 12 2001 Particular requirements for the safety of lung ventilators for medical use Electromagnetic compatibility EMC According IEC60601 2 2 Edition 11 1 2 Operating Conditions Operating Temperature Range 10 to 40 C 50 104 F Operating Atmospheric Pressure 700 to 1060 mbar 10 2 15 4psi Operating Altitude 443 3048 m 1350 10 000ft Relative humidity 10 to 90 11 1 3 Non operating Conditions Storage temperature 15 to 50 C Storage relative humidity 10 to 90 MV2000 SU M Ventilator 11 Technical Specification Storage Atmospheric Pressure 500 to 1060 mbar 7 3 15 4psi Storage Altitude Up to 6560m 20 000ft 11 1 4 Power Supply AC input voltage 100 120 VAC 10A 50 60Hz 200 240 VAC 5A 50 60Hz AC input FUSE Rating 250V 6 3A Power consumption 84W max External DC input voltage 12V 7A Pb battery Internal Battery 12V 7A Pb battery Operating time 3 hours Recharge time 4 hours 11 2 Ventilator 11 2 1 General Dimensions mm Main unit W330 X D250 X H400 Display monitor W310 X D48 X H280 Cart W480 X D570 X H770 Weight kg Device 37kg with Battery Cart 20kg 11 2 2 Gas Supply Gas Quality Gases supplied must be appropriat
22. store the product in a place that may cause the patient any harm Do not store the product in a place where the product could be exposed to extreme impact or vibration MEKICS Co Ltd Ge 7 Do not store the product in a place where the product could be exposed to chemicals or explosive gases LG 8 Be careful to prevent dirt especially metal materials from getting inside the product BS 9 If the product dysfunctions do not disassemble the product yourself Only MEKICS service personnel and designated service technicians are authorized to disassemble the product for repair or battery replacement If you disassemble the product yourself you will not receive any service for the product 10 Turn off the product when you will not be using the product for a while MV2000 SU M Ventilator 1 Introduction 1 2 3 Cautions for Use AN WARNING 1 This product is extremely dangerous when used or stored in places exposed to chemical substances or explosive gases Battery may explode when using the product under flame or high temperature Do not disassemble or dismantle the product Our company will not take any responsibility on disassembled products Read this manual prior to use and check settings for various sensors and devices This product should only be used by an authorized individual with sufficient knowledge about patient monitoring devices The product must be verified regularly
23. target volume mL 3 Minute Volume Vmin Volume per minute or target minute volume 47 MEKICS Co Ltd 6 Ventilation Mode and Function 4 Inspiratory Pressure Level 5 Inspiratory Rise Time Arrival time from the start of each respiration to flow pressure peak 6 LE Ratio LE Inspiration time Pause time Expiration time 7 Inspiration Time Delivered time to patient of flow or pressure 8 Pause Time Temporary pause time during which flow or pressure is halted without delivery 9 Trigger Flow Trigger Pressure Trigger Flow is that the amount of bias flow can gradually be reduced for induction of ventilation Trigger Pressure is that pressure must be created below the configured PEEP through inhalation of excessive bias flow to induce ventilation 10 PEEP Positive end expiratory pressure cmH20 48 MV2000 SU M Ventilator MEKICS Co Ltd 7 Alarm 7 1 Introduction MV2000 SU M ventilator includes an alarm system for the patient s safety In case of the following problems alarm sound is created with screen display Breathing problem ex Apnea Power problem ex Battery mode Gas problem ex Reduced gas pressure This Chapter describes general response method sequence of alarm setting refer to Chapter 4 Operation Method for details range of alarm setting and list Refer to Chapter 8 Alarm Message for details on causes and solutions to all alarms A W
24. time Only operated in Spont mode Apnea occurs to notify backup mode operation Alarm continues to sound during VENT VACV PACV mode After apnea i l i i 2 Backup Mode i operation Backup mode operates if Apnea mode is operated in ime Spont mode Mode is switched to Spont mode in case of two spontaneous breaths in 10 seconds Obstruct When inspiration outlet or expiration inlet are blocked If configured value or default alarm limit is exceeded Expiratory One minute If there is an increase in the patient s effort for breathing 4 Minute after Vent If self triggering auto cycling of the ventilator occurs Volume High operation If alarm setting is inappropriate This alarm is operated one minute after Vent mode operation If configured value or default alarm limit is exceeded i i If there is little effort by the patient to breathe Expiratory One minute 5 Minute after Vent If there is leakage around cuff i If there is leakage in the patient s tube line Volume Low operation REE i If alarm setting is inappropriate This alarm is operated one minute after Vent mode operation If high pressure exceeds setting or default alarm limit If tube line is twisted or blocked If a mucus or secretion blocks endotracheal tube or airway Pressure High Immediate If the patient coughs or fights with ventilator If inspiratory flow is extremely high If alarm setting is inappropriate If expiratory filter is blocked MV2000
25. ventilation is paralleled based on air volume if there is no spontaneous breathing The spontaneous pressure supported breaths are defined by the setting for Pressure Support Pressure TIME TRIG PEEP cmH20 RESP R BPH TRIGGER TYPE 45 46 a 3 gt 90 FLOW PSUPP cmH20 TRISE PS sec FTRIG LPM 60 0 5 APHEA sec TPAUSE sec a 01 The following parameters are configured in VSIMV mode Tidal Volume ml Respiratory Rate b min Pause Time sec PEEP cmH20 Oxygen Concentration Inspiratory Time sec End Flow Inspiratory Trigger Sensitivity WO Do N Oo R S w RO FE Expiratory Trigger Sensitivity 10 Trigger Flow Trigger Pressure MV2000 SU M Ventilator 6 Ventilation Mode and Function 11 Trigger Setting lpm cmH gt 0 12 Pressure Support cmH gt 0 13 Trise Pressure Support cmH gt 0 14 APNEA sec 15 Mask Mode On Off SIMV mode is a mode in which mandatory breath and spontaneous breath are mixed SIMV mode guarantees one mandatory breath for each SIMV cycle Mandatory breath is either Patient Initiated Mandatory PIM or assisted Ventilator Initiated mandatory breath or Mandatory VIM or controlled mandatory breath As in the following figure each SIMV breath cycle is divided into two parts One is mandatory interval Im and another is spontaneous interval Ts Once PIM breath is delivered mandatory interval ends and spontaneous interval Ts begins If
26. 51 1 3 2 Alarm Setting scissione eiee a e EE EE E E A E i 51 8 Alarm Message 52 SLO U TO a E EE EE EE ETE E E EEEE A 52 8 2 Alarm and Error Me ssag c ccccccscssesessessssesessesessescssessssesussesussesussesussessssesuesesssesessesesseaeesesesseseeseaeeneaeess 53 9 Supplementary Devices Le 56 9 1 MEKICS Humidifier VH 2600 uu cc csessssssssessessssssesseeseesecsssussessessseseescsussesseeseeseeneesseeseeseeseenen 56 52 HO ON 56 9 2 1 EtCO Connection Method rmseaerrvmnsrnsersimrmnenmmmmmmmmmenmmmmnmmmmmnmnmnnenne 56 NNN 57 1500 ON 57 LO Initial Screen Configuration omsanvrnrvrnvrnsrvorvrrsrvsrvensrvsrvensrnsrvensensrvensensrvensensrsensensrsensensrsensenersensenersessesersenenn 59 101 hodt 59 10 2 Start Up Configuration onvsnsrvrrvrnsrvrrvensrvsrversevsrvnsevsrvensensrvensensrvensrnsrsensensrsensenersessenersessenersessesessessevessene 59 10 3 System SMN 60 EEE o 60 VPN 61 Sn 61 EEG FEE 0 9 ENE 62 11 Technical Specification eoervrnvrnrrvrrvrnsrvrrvrnsrvrvensrvsrvensrvsrvensensrvensensrvensensrvensensrsensenersensenensessenersensenersesserersnenn 63 11 1 SYSTOIMN ERE 63 EE REE 63 TELZ Operating EG 6 19 10 0 SJ 63 MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents 11 1 3 Non operating NI 63 TELA POW UPON aa A ernest e rene ert vent renner SER PER ERE PER FEE SER SEN SETEl 63 TEN EA Ce ee 63 INN 63 22 63 11 2 3 Patient System Connectors snrnrsnsrsers
27. ARNING Potential risk can be increased if default alarm values applied to ventilators or other similar devices used in same place differ from each other A ATTENTION If an alarm occurs measures must be taken by a medical professional with experience in ventilator treatment or an individual trained with MV2000 SU M ventilator MV2000 SU M Ventilator 7 Alarm 7 1 1 Alarm Display If an alarm occurs it is displayed on the screen with a message as follows V ACV 3072 om ER toll YE ann n nn TE ty 1 Alarm message window flickers and displays the cause of alarm 2 Measurement value window corresponding to the alarm will flicker 7 2 Alarm Removal 7 2 1 View Current Alarms 1S be Pac Fie ie FAN More than one alarm can be checked Trout alarm message displayed on top of the screen To check more alarms 49 MEKICS Co Ltd 1 Choose Events menu on bottom of the screen 2 Select Alarms among sub menu of Events to see all recent alarms 7 2 2 Alarm Removal Current alarm messages and alarm actions can be canceled by pushing Alarm Reset button among fixed keys at the bottom of the monitor Also alarm action is automatically canceled if the alarm condition is settled Ds norte Alarm sound can be muted without settling current alarms However sound may operate intermittently depending on the situation
28. AS WARNING If the trigger sensitivity is set too high a self triggering auto triggering condition may be reached This condition can also be reached if there is leakage in the breathing system Triggering will then be initiated by the system and not by the patient This should always be avoided by decreasing the trigger sensitivity 6 3 2 Inspiratory Rise Time Time adjustment from starting point of inspiration to time of peak flow or peak pressure Inspiratory frise time 34 MEKICS Co Ltd At the starting point of inspiration for each breath it can be adjusted the arrival time to peak flow or peak pressure as second or percent of respiratory cycle If rise time is high increased flow pressure and it is displayed through flow and pressure waveforms Inspiratory rise time is applicable in Pressure Control PRVC SIMV Pressure Control Configuration of inspiratory rise time is 0 1 0 5sec In general rise time must be configured higher than default system value in order to deliver comfortable ventilation to the patient in support mode 6 3 3 Respiration Rate Respiration rate refers to the number of respirations or breaths per minute The respiratory rate is also used for calculation of tidal volume if the ventilator is configured for Minute volume setting 6 3 4 Apnea Time Apnea time refers to set apnea time until beginning of controlled ventilation in Spont mode Range o
29. CS Humidifier VH 2600 Refer to User Manual of MEKICS Humidifier for details on cleaning and sterilization methods 81 MEKICS Co Ltd Annex 3 Maintenance Appendix 3 Maintenance Refer to the following diagram for battery i i i replacement Appendix 3 1 Preventive Maintenance The device must be regularly inspected Preventive maintenance included in service manual is carried out in case the amount of use of the ventilator is smaller than ordinary use Receive at least one inspection per year from the technical team of our company In general a ventilator is expected to run about 5 000 hours per year Always clean inspiratory channel prior to preventive maintenance Inspiratory cleaning must be performed by a trained expert Appendix 3 2 Battery Replacement Internal battery is used to supply power to the product when the patient is moving Battery is automatically charged when external commercial N WARNING Be careful about polarity when replacing battery Connect to red and to black if polarity is mistaken it may damage the power is supplied Once commercial power supply is terminated or power supply is suspended accidentally power is automatically switched to internal battery Remaining battery is indicated on the LCD monitor product Since current is high battery may explode from short circuit and cause harm on human body Use rated voltage and current 12V
30. Eng Ver 1 10 0 Apr 2013 User s Manual MV2000 SU M Ventilator System C 0470 This User Manual may be revised for the improvement of the product without prior notification Images in this User Manual may differ from the actual product MV2000 SU M Ventilator MEKICS Co Ltd Eng Ver 1 10 0 Apr 2013 User Manual This User Manual is provided to users with MV2000 SU M Ventilator product Since this User Manual is compatible with MV2000 SU M Ventilator it may not be used with other products manufactured by our company In case of loss or damage in the User Manual you may refer to MEK ICS web site for downloading the manual file URL http www mek ics com MV2000 SU M User Manual includes precautions and risks to users prior to use of ventilator Please read all precautions for use thoroughly before operating the Up product i You may quickly find wanted information using the table of contents during operation al If you have any inquiries on details of the product contact our company or visit Customer Service Center Notice This document includes exclusive information protected by copyright The copyright law prohibits unauthorized copying and modification of the document without prior approval Warranty Contents included in this document may be changed without announcement Our company is not responsible for any problems and damages caused from use of performance or dat
31. Function Pressure Volume Compliance NE At nssnesenonaavnsessseensenesnsneenngge Target Volume Compliance Change During the breathing the pressure regulated according to compliance changing of patient Pressure Changed Regulated in breath by breath Target Volume J 6 11 O Stream This mode can be used for nasal CPAP and high flow therapy This mode controls a micro miniature flow along with adjusting O gt flow The conventional CPAP must be used with a humidifier in order to a patient breathing air should be moisture but Oz Stream flows O gt gas at the same time with air the breathing air will be easy for a patient s nasal and lung Oz Stream supports a positive airway pressure on the control flow to reduce the dead space at a patient s lung limited Pressure Peak pressure is using Limit P_limit for safer application to the patient 43 MEKICS Co Ltd 02 Stream Flow Pressure FPEAK LPH PLIMIT cmH20 TRIGGER TYPE 10 The following parameters are configured in 02 stream mode Inspiratory Peak Flow Lpm Pressure Limit cmH gt 0 Oxygen Concentration Trigger Flow Trigger Pressure Ur ooe EE e Trigger Setting lpm cmH20 6 12 AutoVent Though it is a single mode this mode is actively operated according to the status of the patient throughout ACV gt SIMV gt Spont modes while guaranteeing minute volume Optimal WOB Work of
32. M Ventilator MEKICS Co Ltd 12 Summary of Screen Usage 12 3 Menu Keys hal a mm Ft 5 System Composed of operation condition setting patient information date and various calibration settings 6 Alarms This menu is used to configure various alarms on measurement values 7 Modes If Modes is pushed to select ventilation mode setting window for corresponding ventilation mode appears Accept Cancel can be used to save or cancel the selected ventilation mode If Accept button is pushed new ventilation starts as configured by user If Cancel button is pushed existing ventilation is maintained 2 MV2000 SU M Ventilator MEKICS Co Ltd 12 Summary of Screen Usage 12 4 Screen Touch Pads 1 Direct Access When changing setting values t ventilation setting values ei each ventilation mode can be changed 2 Nebulizer Nebulizer is turned On Off using touch pad 3 Freeze If Freeze pad is pushed graph freezes temporarily Trend value can be searched in trend screen 4 Measurement Value Measurement values during ventilation are displayed More measurement values can be seen by touching arrows Use Monitoring menu to see values at once 5 Touch Screen key Lock Push Key Lock pad to disable all touches on the screen Touches are enabled by pushing Key Lock once again 13 MV2000 SU M Ventilator MEKICS Co Ltd 13 MV2000 SU M Series Features 13 MV2000 SU M Series Features ssf SUMB MaW
33. Nr 35 SEE i OI EEE 36 ANN MO LE SEE Er eee 36 6 4 V ACV ee ee ee ee ee ee ee ee ee ee ee ee ee eee ee eee eee 36 BP rcs ses cc ccc E N ENE 37 6 6 V SIMV Ve 39 G F PN coco cs ct ches cto cto A NOA 40 6 8 SPONT cscs cs csc csc rte EEE EDENE engene EE OEE EE EEEE E OESTE TEE EE OE EEEE EEO eects 40 6 9 tBiLEVEL Spontaneous Ventilation nsonsrvrnrrvrnrvrnrvrnsrvensrnrnsrnersrnensenersenensenrsenersenensenersenersenersennenn 41 6 11 O StreaMm sosnvonnvonreenrenresnreennenreenrennesnreenrennesnreeneeereenreenresnesnresneeenesnreneeenesnreneennesnresneennesnrenessresnseenesnresnseenesnneene 43 6 12 ANN 44 6 13 SHFV Single High Frequency Ventilation sonorvrnrrvrnrrrrnorvrnsrvensrvensrvensrnersrnersrnensenersenersenersenenenn 45 6 14 DHFV Dual High Frequency Ventilation soornrrornrrvrnrvrnsrvrnsrvensrversrvensrnensenersrnensenersenerserensenenenn 45 b1ISTEPLNAE LG 46 6 16 TCPL SIMV nnrnrrvrrnrvrrvrrsrnsrsrrsrnsrsrnsrnsrsersrnsrsrrsrnsrsrrsensrssrsrssenrssensessssessesrssessrssssessrssssessesssseserssssesssssssesssssssesssssssene 47 6 17 Ventilation Parameter Outline srnnrnrrvrnsrnsrvrnsrvsrvrnsrnsrnrrsrnsrsrnsrnsrsrssensrsrssessersrssesersrssessrssssesssssssessrsessene 47 TPM 49 7 1 Introduction css treerne 49 MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents 12 Me FN 49 2 Pausing Alarm SN 50 7 2 4 Alarm Sound Volume TONO Lvpvv4vs vs 50 J Anm So N EE 51 7 3 1 Alarm SEND
34. OFF Auto DRY Selected if using without humidifier and the following parameters are configured Refer to Chapter 4 Operation Method for details Auto Humid Selected if using with humidifier 1 BED Num 6 Sound Vol Designate patient s bed number Decide alarm sound volume for the ventilator 2 ID Range 10 100 Input patient s ID number 3 IP 7 Graph speed Input IP address for external connection using Configure waveform graph sweep speed LAN Settings x1 x2 x4 x8 x16 4 PORT Input port number for external connection 8 CO Unit using LAN Configure CO Unit 5 PASSWORD Settings or mmHg Configure password 77 for IP and port input 9 Language 10 3 3 Date Configure the language to be used The supported language is English Russian amme Spanish and Chinese MV2000 SU M Ventilator MEKICS Co Ltd 10 Initial Screen Configuration Ventilator s date is configured in Date menu MAIN and PNEU SW version operation time of ventilator and remaining O2 are displayed Date configuration sequence is Year Month Day Hour and Minute 10 3 4 Calibration In Calibration menu sensors used in MV2000 SU M ventilator are calibrated Refer to Chapter 4 Operation Method for details 62 MV2000 SU M Ventilator MEKICS Co Ltd 11 Technical Specification 11 1 System 11 1 1 General MV2000 SU M ventilator selected and acquired the following international
35. PIM breath does not occur until the end of mandatory interval VIM breath is provided to the patient as soon as mandatory interval ends and spontaneous interval begins PIM JSN gt h T rr 1 fT g JU _ c e a y Imc In SIMV mode SIMV breath cycle is determined by configured respiration If respiratory rate is configured as 12 times SIMV breath cycle is 5 seconds Mandatory interval is smaller value either 10 seconds or 0 6 x SIMV breath cycle Mandatory 39 MEKICS Co Ltd interval can be shortened depending on PIM breath 6 7 P SIMV Pressure based Synchronized Intermittent Mandatory Ventilation This mode controls ventilation based on pressure according to spontaneous ventilation by the patient In other words this mode combined control and pressure support spontaneous function allows for preset mandatory breaths synchronized with the patient s breathing Mechanical ventilation is paralleled based on air volume according to spontaneous ventilation or in case there is no spontaneous ventilation using configured time period The spontaneous pressure supported breaths are defined by the setting for Pressure Support Pressure TRIG PEEP cmH20 TRIGGER TYPE FLOW PSUPP cmH20 TRISE PS sec APHEA sec ExSEWS 60 0 5 5 80 D 0 1 2 10 The following parameters are configured in P SIMV mode Inspiration Pressure cmH20 Inspirati
36. Pressure Regulated Volume Controlled Ventilation Despite advantages of pressure mode instability of not guaranteeing inspiratory volume caused by long term or acute change in patient s respiratory status or long term change in lung compliance is removed 64 MEKICS Co Ltd Time Control Pressure Limited TCPL peak inspiratory pressures is set by operator and during inspiration gas flow is delivered to achieve that set pressure Especially it is recommended mode to neonatal patients 11 4 2 Supported Ventilation SPONT Spontaneous Ventilation This mode provides pressure support based on spontaneous ventilation tBiLEVEL Spontaneous Ventilation Identical to SPONT mode but only upper PEEP exists 11 4 3 Combined Ventilation VSIMV Volume Based Mandatory Ventilation Synchronized Intermittent This mode controls ventilation based on air volume according to spontaneous ventilation of the patient PSIMV Pressure Based Mandatory Ventilation Synchronized Intermittent This mode controls ventilation based on pressure according to spontaneous ventilation by the patient 11 5 Communication Interface Serial Port RS 232C isolated For Upgrade Firmware Main Board Pneumatic Board Baud rate 115 200bps MV2000 SU M Ventilator 11 Technical Specification Standard I O Communication Port Monitor 12 1 TFT LCD Resolution 800 X 600 11 6 Service AN WARNING A S on the de
37. SU M Ventilator MEKICS Co Ltd Do Occurrence Alarm Immediate Message Separate l After taking Respiratory Rate High mean value on four respirations i After taking Respiratory mean value on Rate Low four respirations Tidal Volume i Immediate High After taking ar O Tidal Volume mean value on Low Vtidal of three respirations One minute after O High Vent mode or O alarm setting One minute after O Low Vent mode or O alarm setting Gas Supply Immediate Pressure Low MV2000 SU M Ventilator NO UJ m IS ar UT m m m I ar Od MEN N 8 Alarm Message Criteria If low pressure exceeds setting or default alarm limit If there is leakage around cuff If there is leakage in the patient s tube line If alarm setting is inappropriate Spontaneous breathing is not applied If respiratory rate is too high If auto triggering occurs If higher than setting alarm limit If respiratory rate is too low If trigger sensitivity setting is inappropriate If lower than setting alarm limit If setting or default alarm limit is exceeded If there is an increase in the patient s effort to breathe If self triggering auto cycling of the ventilator occurs If alarm setting is inappropriate If setting or default alarm limit is exceeded If there is leakage around cuff If there is leakage in the patient s tube line If alarm setting is inappropriate Sponta
38. a different from the details of this document Revision History Part and revision numbers in this document represent current version The revision number is not changed if subordinate documents are modified or supplemented The revision number is only changed in case of change in part numbers or technical matters MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents EE od 1 IDE IN ee ee ee 1 ELDE IUS TIO orrian a E Z 1 He 1 Li VA 1 LA 1 1 1 5 Environment smmsrsrnsrsrrsrsrssrsrrsrsrrsrsersrsrrsrsrssessssenrssessssensssessssensssessssessssessssessssessssessssessssessssessssessssensssessssessssenenee 1 1 1 6 Service Guideline pr 1 1 1 7 Exceptions for Legal Responsibilities mrvrrnvvrnsrvrrvrssrvrrvrssrsrrverserersersererverserersensesersersesersersenensenenn 1 1 2 Warning Caution Important and Reference Matters swsssrrsrsrrsrsrrvrnsrvrrvrssrrsrversrvrrsessesersenenn 2 LITT a A E A E E E E SELE ERETE ES DRETEFET REFERERE TERE 2 1 2 2 PRECAUTIONS Tor Storage roere enirir renine nin AEn E NER AENEAS NENONEN NONE ERASE KSNNEN eee ere 3 VET Ev 4 1 2 4 Precautions for Electric Safety nurmmmnvnvnsvnnnsese 5 125 PRECAUTIONS tor Electronic Salely seerne ke ver 6 2 System OT SN 7 2 1 Ventilator Configuration mmmsanvrvrrvrnsrsrrversrvsrversrvsrvensrvsrvensrnsrvensensrvensrnrsensenersensenersensenessessenersessevessersesensene 7 2 2 User Interface
39. alculated values MV2000 SU M ventilator has two gas modules Oz air Gas can be supplied through hospital s medical gas supply system or compressor and gas container AN CAUTION When not moving the ventilator wheels must be fixated using lock In order to prevent movement of the ventilator from carelessness check whether the ventilator is fixated to the correct position on the cart 1 User Interface Screen 2 Patient Unit Main Body 3 Mobile Cart 4 Inspiration Outlet 5 Expiration Inlet 2 2 User Interface Connection Label Symbol MV2000 SU M Ventilator MEKICS Co Ltd User interface is composed of the following Touch Screen Fixed Keys Encoder Rotational Dial 2 2 1 User Interface Configuration Refer to the user interface diagram on the next page to check for location of the following oo JDU es 2 10 11 12 13 14 15 16 17 18 19 20 Display of current ventilation mode Alarm display and alarm message window Status icon Date time O2 100 display Nebulizer On Off display Ventilation mode setting Measurement value display Pad to view diverse measurement values Waveform window Three parameter waveforms pressure flow and flow volume loop display Various menu to operate ventilator MV2000 SU M Pad to add or change setting values Power supply AC green BATT orange Touch key lock unlock LE graph System On O
40. and Function 32 MEKICS Co Ltd 6 2 Waveform Description The graphic display for flow pressure and volume is displayed in waveforms Patterns for flow pressure and volume differ directly according to each ventilation mode 6 2 1 Volume Control FE Pressure Time Waveform X Inspiration time Y Pause time Z Expiration time Start of Inspiration Peak inspiratory pressure Early inspiratory pause pressure End inspiratory pause pressure Early Expiratory pressure Om RA W N e End Expiratory pressure Flow Time Waveform X Inspiration time Y Pause time Z Expiration time 7 Peak inspiratory flow 8 Zero flow phase 9 Peak expiratory flow 10 Slope decelerating expiratory limb MV2000 SU M Ventilator 6 Ventilation Mode and Function 11 End expiratory flow Volume Time Waveform X Inspiration time Y Pause time Z Expiration time 12 Start of Inspiration 13 The Slope displays inspiratory tidal volume per respiration 14 End Inspiration 15 The Slope displays expiratory tidal volume per respiration 16 End expiration 6 2 2 Pressure Control i X Z 2 I Pressure Time Waveform X Inspiration time Z Expiration time 1 Start of Inspiration 2 Peak inspiratory pressure 3 End Expiratory pressure Flow Time Waveform X Inspiration time Z Expiration time 33 MEKICS Co Ltd 4 Peak in
41. attery icon on the battery capacity Do not leave battery module bottom right is displayed in red color Here unattached or stored for long time If it is battery should be replaced or if possible connect necessary to store a battery for short time the ventilator to main power source fully charge the battery and store at low temperature 15 20 C or 59 68 F under dry Information on battery module inserted in the environment ventilator is displayed as follows Stored or unused battery must be charged Full Disposed batteries must be handled in gt RER o accordance to local regulations Do not discard ER with pene wastes Charging After replacing with new battery check the status of new battery for safe operation Charging Battery may not be fully charged upon initial oo supply of the product Use user interface to oo pe check charging status If necessary connect If remaining battery is the ventilator to main power source to charge low the icon is the battery prior to use displayed on the Discharged battery must always be charged screen In order to for use protect the battery When the ventilator is not in use it must cues beep sound is created always be connected to main power source to and power is charge the battery automatically turned off after about 5 3 3 2 AC Power Supply Failure minutes If there is no AC power supply or power outlet is disconnected the ventilator automatically operates
42. by hospital local government and national government 1 1 7 Exceptions for Legal Responsibilities Inappropriate environment Our company is not responsible for safe MV2000 SU M environment described in this Manual is not operation of ventilator if followed Service by a non professional If this product is serviced or repaired by an who did not relevant individual complete MEKICS Co Ltd training our company is not responsible for safe operation of MV2000 SU M 1 2 Warning Caution Important and Reference Matters Symbols are indicated on the interior and exterior of the product and in this User Manual The symbols represent important cautions and advice to the user Please read the following symbols carefully and be well informed of them for the use and storage of the die dl AN DANGER This symbol represents DANGER It is associated with possible matters that may greatly harm the product or the patient or might even cause the patient s death AS WARNING This symbol represents WARNING It is associated with possible matters that may harm or cause irreversible damage to the product or the patient AS CAUTION This symbol represents CAUTION It is associated with possible matters that may damage the product or harm the patient A ATTENTION This symbol is associated with safety issues that the user should give attention to and be well informed of before using the product How to us
43. d Information Saving 28 MEKICS Co Ltd 6 Ventilation Mode and Function 6 1 Introduction modes can be used in MV2000 SU M Ventilator System This Chapter describes the ventilation modes their settings and Diverse ventilation associated safety information Refer to technical specifications for description on default settings and range of each parameter for the system DS note MV2000 SU M Ventilator System is delivered according to the following setting method Setting of parameters are based on minute volume or Tidal Volume Setting of parameters are based on E ratio or inspiration time 6 1 1 Warnings DZ note Not all warnings below are applied to all ventilation modes MV2000 SU M Ventilator 6 Ventilation Mode and Function N WARNING Alarm setting for each ventilation mode must be configured appropriately In particular be careful for the following alarms m Minute volume or tidal volume m Apnea alarm risk of self In order to prevent triggering do not configure trigger sensitivity as too high sensitive Be careful about upper pressure alarm setting to protect the patient s lungs from excessive pressure Excessive inspiratory pressure can cause swelling of abdomen or aspiration It may also be a cause of excessive leakage only applied in Mask Mode 6 1 2 Types of Ventilation The ventilator provides the following ventilations 1 Controlled V
44. d by MEKICS If a different product is used there may be a problem in performance Sensor should not be used on parts with artery catheter or vein syringe Do not use damaged SpO sensor or optical device Since the sensor is not waterproof do not place in water and solvent or clean excessively Do not sterilize the sensor with ultraviolet ray direct sunlight steam or hydrogen peroxide MV2000 SU M Ventilator 9 Supplementary Devices AN CAUTION Do not use the sensor to patients with allergic symptoms to SpO2 sensor Immediately remove the sensor if the patient calls for discomfort S MEKICS Co Ltd AN ATTENTION Inaccurate values and waves can result as below if sensor is used incorrectly When sensor not certified by MEKICS is used or sensor is used incorrectly Functional disorder in hemoglobin When sensor is excessively exposed to medical light especially xenon light bilirubin light fluorescent light infrared heating device or direct sunlight Excessive movement by the patient Use of high frequency electric surgical instrument or cardiac resuscitator Pulse of venous blood Measured at a spot where blood pressure Is measured pressure bandage is used artery catheter is used or sensor is used inside blood vessel Measured at a spot where blood pressure Is measured pressure bandage is used artery catheter is used or sensor is used inside blood vessel When there is arterial
45. displayed among P V V F and P F on 4 MV2000 SU M Ventilator MEKICS Co Ltd 5 3 Event Log EKTET TIE ETTE a A To check the event log 1 Select events menu on the bottom of user interface 2 All recorded events can be seen in events menu A Setting History of changes in setting is recorded Alarm History of alarms is recorded C ALL alarms are recorded All events can be History of setting changes and seen 3 Use arrows on the right side to search through the list of events MV2000 SU M Ventilator 5 Monitor and Information Saving 5 4 Loop Loops function displays the relationship among Pressure Flow Flow Volume and Pressure Volume as graphs Refer to Section 5 2 2 for loops graph setting 5 5 Trend Trend value is saved every time the patient respires Trend timing configured in graphics menu refers to the step in which trend data can be searched Trend timing in graphics menu can be configured as follows LRESP LORESP 30RESP 60RESP If 1 RESP is designated Trend data can be searched at every respiration Refer to Section 5 2 2 for trend graph Trend graphs can be seen using Layout 4 and Layout 5 27 MEKICS Co Ltd Trend Setting and Graph Sequence Diagram r Cell Grophics E JE HE El i Ku LT ET LE FS EH H BG 0 EK Trend Timing Graphics menu Layout 5 MV2000 SU M Ventilator 5 Monitor an
46. e screen only displays O concentration of 21 or higher The alarm is delayed 60 seconds after changing the O concentration setting 6 3 10 Proximal Sensor On Off This option must be used for low flow pressure flow supplemented patients who require precise flow measurements and tube compensation such 35 MEKICS Co Ltd as premature and neonate patients It is safe to use this function in supported ventilation below 200ml Appropriate sensor for adults for infants must be used depending on the patient 6 3 11 Mask On Off This option can be turned On Off in all modes except for O stream and HFV Once turned On leakage compensation ability is increased 6 3 12 Previous Mode 1 Time when previous mode was inactivated 2 Name of the previous mode 3 Press the pad Show previous mode to recall the previous accepted ventilation mode 4 Activate the previous used ventilation mode settings by pressing the Accept pad 6 4 V ACV Volume Controlled Ventilation Volume control mode is based on mechanical ventilation method and the ventilator delivers configured tidal volume to the patient VACV mode is a mode that controls mechanical ventilation of the patient based on air volume It controls inspiratory and expiratory times by force Volume Flow Pressure TRIG RESP R BPM PEEP cmH20 TRIGGER TYPE SIGH MODE RPE 120 OFF OFF MASK OFF MV2000 SU M Ventilator 6 Ventilation Mode and Functio
47. e the product is described in each section of this manual Snore This symbol is associated with issues you should note regarding the surrounding MV2000 SU M Ventilator 1 Introduction environment or additional references to the descriptions in this manual It does not pertain to possible damages to the product or the patient 1 2 1 Summary This booklet summarizes characteristics of the MV2000 SU M ventilator system Since not all details of MV2000 SU M are included in this booklet do not use this booklet functions and as a document for training I WARNING Always perform pre checking prior to connecting the ventilator to a patient In case of the following stop the use of ventilator and contact service assistant If unordinary screen Shows up If an alarm cannot be settled If the device creates abnormal sound If the device is operating abnormally or shows unexpected failure The ventilator must always be maintained vertical during use If the ventilator is connected to a patient gt Carefully monitor the patient Prepare for reserve ventilators for easier USE Do not raise or separate expiratory part Always check setting and measurement values displayed on the screen MV2000 SU M operated by an experienced user in ventilator must be accordance to guidelines given in this booklet Do not cover the ventilator in any way This may cause errors in its functio
48. e to medical gas standards Ozand air supply Pressure range 35 90 psi 63 MEKICS Co Ltd Oxygen sensor life 1 000 000 Vol h Safety pressure Pneumatic 30 psi 10 Inspiration Pressure Limit 100 cmH gt 0O 10 11 2 3 Patient System Connectors Conical fittings mm Inspiratory limb connector ISO 22mm male Expiratory limb connector ISO 22mm male Air and Oxygen inlets DISS male female 11 3 Alarms reese HIGH amo Bem rrRespiow 28 fom SpO gt HIGH optional OFF 51 99 optional PR HIGH i 30 250 BPM optional MV2000 SU M Ventilator 11 Technical Specification PR LOW 25 245 BPM optional EtCO gt HIGH l 0 10 0 mmHg optional EtCO gt LOW OFF optional 0 9 9 INS HIGH i 0 10 0 mmHg optional INS LOW OFF 0 9 9 mmHg i mmHg optional RESP HIGH i 3 150 BPM optional RESP LOW i 2 149 BPM optional Wall O2 Air pressure fail Obstructed Tube Ventilator operation i BE 11 4 Ventilation Modes 11 4 1 Controlled Ventilation Volume Control VACV Volume Assist Controlled Ventilation Circuit open Mechanical ventilation is controlled based on air volume adjusting inspiratory and expiratory times by force Pressure Control PACV Pressure Assist Controlled Ventilation This mode controls mechanical ventilation of the patient based on pressure Pressure Regulated Volume Control PRVC
49. entilation 2 Supported Ventilation 3 Soontaneous Breathing CPAP It also allows for combined ventilator control or support Spontaneous breathing efforts are sensed during controlled ventilation ex SIMV functionality The AutoVent functionality continuously adapts to the patient s breathing capability When required all ventilation is provided for mandatorily When the patient is able to initiate a breath the ventilator supports and monitors the patient s controls breathing capability and ventilation only if required 29 MEKICS Co Ltd 6 1 3 Ventilation Control Method Ventilation is controlled by the following elements A Pressure and Volume B Pressure C Flow Volume Pressure and Volume This method guarantees constant inspiratory tidal volume per respiration by controlling pressure and flow Inspiratory pressure level is maintained constant during each breath PRVC Volume Support Pressure Pressure level configured during inspiration time is maintained constant Pressure control Pressure Support Flow Volume Tidal volume per respiration is maintained constant during inspiration time by flow volume control Inspiratory flow is maintained constant during breath Volume Control Extra Flow and Extra breaths If demanded flow by the patient can be triggered during inspiration time additional flow is delivered Also if the patient s effort for ventilation coincides with conditions of
50. entilator The ventilator automatically shifts between controlled ventilation supported ventilation and spontaneous ventilation 31 MEKICS Co Ltd Each controlled ventilation mode has a corresponding support mode Volume Control lt gt Volume Support PRVC lt gt Volume Support Pressure Control lt gt Pressure Support When the patient is making a breathing effort the ventilator immediately switches to a support mode of ventilation If the patient is not making any breathing effort the ventilator will return to the controlled mode and deliver controlled breaths Synchronized Intermittent Mandatory Ventilation SIMV The ventilator provides mandatory breaths which are synchronized with the patients spontaneous efforts at a preset rate The mandatory breaths can be Volume Control Pressure Control or PRVC breaths tBiLevel tBiLevel is pressure controlled breathing giving the patient the opportunity of unrestricted spontaneous breathing Two pressure levels are set together with the individually set duration of each level Spontaneous efforts can be assisted by pressure support TCPL A peak inspiratory pressure is set by the operator and during inspiration gas flow is delivered to achieve that set pressure The volume of gas delivered to the patient in this TCPL varies depending on pulmonary mechanics such as compliance of stiffness of the lungs MV2000 SU M Ventilator 6 Ventilation Mode
51. essesessescssessssesussesussesessesussessssessesesssescsesessesesseeeeseaeeaes 79 Appendix 2 5 ASSemMDIY cats 80 Appendix 2 6 EtCO2 Module Cleaning Sterilization omnvrnsnvrnrrvrnrrvrrrvrrsrvrnsrnrnsrnersrnensrnersenensnnnnne 80 Appendix 2 6 1 Preparation c ccccccccssescssescssescssesessesessesssescsssscssescsssscssessssescssesesssscssescsssscssesessesessesessesesseseeseeeaes 80 Appendix 2 6 2 EtCO Module BOdy nnvmnnvrnvvrrrerrrrrrrrorrrsorrrsonerserrssenersenersrnessenersenersenessenessenessenessenessenessensnee 80 App ndix 2 6 3 Airway NN 81 Appendix 2 7 Accessories m mu sssnssnssnsnsessessesesessrsessesessrseseesesresesreressesersesessesessenessenessenessenenee 81 Appendix 3 Maintenance smevanrvrnsrsrnsrsensrvesrsesrsesrsesrsesrsessesrvesrsesrsesesrssesrsrerrsrererreressesessenessenessenessenessensnee 82 Appendix 3 1 Preventive Maintenance sosansrvrnsrvrnsrvrnsrvensrnensrnensenensrnensenensenensenensenersenensenessenessenessenessenenee 82 Appendix 3 2 Battery Replacement sonnrvrnnrvrnsrvrnsrvensrvnsrvrsrnrsrnsnsenensrnensenensenensenensenensenensenensenensenessenessenenee 82 Appendix 3 3 ACCESSOSICS cccccccccsessssesssesscsessssesscsessssessssessssessssesuesesussesussesussesussesuesesssseaseseaussesusseaeseaneseaeeaes 82 Appendix 3 4 Warranty Period o oronrovrrrorrrrrvrnsrvonsosensrsensrsensrnensenessenessrnensenensenensenensenessenessenessenessenessenessensnee 83
52. essrsersensrsersessesersessenersessersessesseversessenensessssersessesessene 25 SS HAL hp 27 ST LON ERE ENE A A E E 27 6 Ventilation Mode and Function insonsrvrvrrsrvsvsrrsrssrsrrsrssrsrrsrnsrrrrsrssrsrrsrnsenersensessssensrssssessessssessessssessesssseseesessene 29 6 1 Introduction mssmnvrvmrvrnsrsrvnssrsrnssrsnssssesrssssssnsesnersesnsrssrsrssesrsesesrsesersnsesessrsesersrsesersrssen 29 INN 29 612 Types of VER HIS ON csxscicczsysctsstpsictcstewar cakwintcatnisdcakeussdcakeaisdcateaiedcak TENE ESNE CENS ASAE ONE CAS ENESE EATE A OSEERE 29 6 13 Ventilation Control NEO 30 6 2 1 Volume NN 33 SJ E EE 0 E A E E E E E A E E E E E E 33 6 3 Setting Parameter Description mmmnvsrsrsvrsvnsnsrnssnssnssnssnssnsnsnssnsnssnssssessseen 34 MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents JER 9 8 Fn O RR EET re 34 63 2 Inspiratory RISE TIME EEE EEE 34 6 3 3 Respiration Rate uuXu uudscssevsesertsssersrererttr ee er ne ee ee eee ee ee eee eee oe 35 6 3 4 Apnea EN 35 LP 35 6 3 6 LE Ratio Inspiratory Twi iasescsccscscascscsccscissceccscesdscnckssdededsesdscadased cadbeadscadcastacaddscdededdad nadauedsesdbeasiusasdstacdetds 35 6 3 7 Volume Level Setting wc ccccccssessssesessessssesessesessesssessssessssesussessssesscsesessescssecesseceeseeeeseeeeseeesseseeseesseenssee 35 6 3 8 Controlled Supported Pressure Level urnrrnsrsnssnssnssrnssessessessessseseseseseseseeseens 35 0 3 9 Oy FERRER 35 PJ PT
53. f setting is 2 60sec 6 3 5 PEEP Setting range of Positive End Expiratory Pressure PEEP is 0 45cmH2O PEEP is maintained in the alveoli and may prevent the collapse of the airways 6 3 6 I E Ratio Inspiratory Time MV2000 SU M ventilator can be done in the following two Inspiratory time setting in methods MV2000 SU M Ventilator 6 Ventilation Mode and Function LE ratio regardless of change in respiration Setting of inspiration time regardless of change in respiration Once inspiration time is configured in the ventilator pause time and inspiratory rise time are automatically changed Change in LE ratio according to inspiration time and pause time is displayed in information window on the bottom right corner of user interface 6 3 7 Volume Level Setting During initial setting for each mode of MV2000 SU M ventilator volume of air supplied to the patient can be configured by adjusting inspiratory tidal volume 6 3 8 Controlled Supported Pressure Level In controlled pressure mode inspiratory pressure PR INSP can be pressure P SUPP can be configured in supported configured Supplementary Pressure Support SIMV modes and tBiLevel 6 3 9 O2 Concentration The setting range of O concentration is 21 100 There is also an absolute minimum limit of alarm is 18 O which is independent of operating setting If the value reaches below this point O fail alarm will sound Th
54. ff switch Standby key is used during operation of the product Standby state is a state in which all things except the ventilator are turned on Manual inspiration O2 100 Encoder Encoder is used to select menu or parameter Also encoder is used to adjust values and save adjusted values by clicking Exit Cancel button Run Accept MV2000 SU M Ventilator 21 22 23 24 25 26 27 28 2 System Outline Execute or run operation Alarm silence Alarm does not make sound for 2 minutes Alarm reset Reset alarms External VGA out port An external monitor can be connected for larger screen or additional screen LAN port RJ45 cable is used to communicate with external devices Connector between screen and main body Connector connects the screen from main body using cable RS232 serial port Serial port is used for DSC software upgrade and communication with COM Speaker Screen panel support MEKICS Co Ltd 2 System Outline 2 2 2 User Interface Diagram MV2000 SU M Ventilator MEKICS Co Ltd 2 System Outline 2 2 3 User Interface Symbol 2 3 User Interface Usage On Off Switch Standby Transition to The following is the general method of using user standby state or display of ventilator on off state IEC417 5009 Manual Inspiration Key Inspiration is applied to the patient every time Manual Inspiration Key is pushed interface according to
55. figure and change the following default values Patient New or Last Patient Range Adult or Neonate Height and Body Weight of Patient Ventilation Mode Including Setting Parameters MV2000 SU M Ventilator 10 Initial Screen Configuration 10 2 Start Up Configuration Initial screen of MV2000 SU M is as follows AK Sonday 1 Add a new patient or load recent patient setting Hev Polen b ret Peier 2 Select appropriate patient range according to age and gender 3 If height of the patient is decided according to age and gender PBW predicted body weight is automatically calculated 7 em K Patient height DV 59 MEKICS Co Ltd 4 Touch measurement screen to move to mode setting screen and configure related parameters Touch Modes button on the top right corner to change ventilation mode and configure parameters TIDL ad TOD FREAK LPN a FEID pill PSS cutt 0 a TEASE sec 0 1 la 3 a TAAA TYRE FL ARES BPN 12 HGH LIDER MFF 5 Ventilation begins after configuring all parameters with patient information and touching Start button 6 Touch the following button to turn the power Off SV norte In the initial standby screen various menu at the bottom can also be used in addition to setting patient information and parameters Matters required for ventilation can be configured through System menu MV2000 SU M Ventilator
56. g value is saved by pushing the encoder 5 Exit This button is used with encoder and touch key to operate menu or to clear the touch window 6 Run This button is used for final operation of the ventilator using values in ventilator set 7 Alarm Silence 2min Auditory signal of alarm is muted for two minutes 8 Alarm Reset This is operated upon reset of alarm Alarm light is turned off 10 MV2000 SU M Ventilator MEKICS Co Ltd 12 Summary of Screen Usage 12 2 Special Function Keys i El ER FE I TEST a A la CI 1 START START button executes ventilation on the patient using current setting 2 Insp Hold Inspiratory Hold 3 Exp Hold Expiratory Hold This can be executed in Tools menu among menu at the bottom Temporary hold function is operated after inspiration whenever button is pushed by user Compliance and resistance are measured after maintaining hold for one second Inspiration end pressure of lung can be accurately measured using this function It can be used during x ray or to determine static compliance static resistance elastance and time constant calculation This can be executed in Tools menu among menu at the bottom Temporary hold function is operated after expiration whenever button is pushed by user Auto PEEP is measured after maintaining hold for one second Expiration end pressure of lung can be accurately measured using this function 1 MV2000 SU
57. gree of contamination ethyl alcohol 70 or isopropyl alcohol 70 is used Avoid contact with electronic connectors MV2000 SU M Ventilator Annex 2 Cleaning Sterilization Appendix 2 3 2 Disposal Bacteria filters Humidifier HME disposable humidifier Disposable tube Appendix 2 3 3 Cleaning Before Sterilization If cleaning process is not included prior to Sterilization using cleaning sterilizer take the following steps Place parts in water lt 35 C 95 F and clean Make water pass through the parts AS ATTENTION Cleaning of cassette immediately after use is another effective method of sterilization Cleaning can easily remove contaminants and reduce risks of cross infection between patients 78 MEKICS Co Ltd Appendix 2 4 Sterilization Process AN ATTENTION Since expiratory cassette is a precise part it must be handled carefully All parts must be dried after sterilization Appendix 2 4 1 Cleaning Sterilizer Clean all parts in a cleaning sterilizer at temperature of 85 95 C 185 203 F Appendix 2 4 2 Disinfectant Place parts in one of the following disinfectants Alcohol ethyl or isopropyl alcohol 70 CidexOPA Hexanios G R Aniosyme DD1 Gigazyme Plus MV2000 SU M Ventilator Annex 2 Cleaning Sterilization Anioxide 1000 AN ATTENTION Follow recommendations and guidelines by the manufacturer Failure to do so
58. h is displayed in yellow EtCO gt vs time graph is displayed in white MV2000 SU M Ventilator 5 Monitor and Information Saving 5 2 2 Waveform Setting and Change Layout and trend timing of waveform can be configured and changed through Graphics menu on the bottom of user interface ENES fr r r Comes mms kl a To change displayed graphs touch waveform The following window appears for each graph allowing user to select wanted graphs Waveform Pressure Flow Volume If SpO gt and EtCO modules are connected through option two additional graphs can be viewed Loop P V V F P F Trend VE min Pmean Ppeak VTe CL RA There are five screen layouts available as follows 25 MEKICS Co Ltd 5 Monitor and Information Saving Layout 1 Three waveform graphs are displayed among pressure flow volume SpO gt and EtCO Layout 4 Two waveform graphs are displayed among pressure flow volume SpO and EtCO gt One Loop graph is displayed among P Layout 2 Two waveform graphs are displayed V V F and P F Two trend graphs are among pressure flow volume SpO and displayed EtCO Layout 5 Two waveform graphs are displayed Layout 3 Two waveform graphs are displayed among pressure flow volume SpO and among pressure flow volume SpO2 and EtCO gt Four trend graphs are displayed mon EtCO2 Two loops are
59. he MEKICS Head Office or MEKICS designated representatives AN ATTENTION 1 This product uses 12V 7Ah lead Pb battery 2 When charging battery connect the AC cable Take care to prevent metal substances from contacting the battery charging terminal MV2000 SU M Ventilator WARNING A strong electromagnetic wave may affect the performance of the product 2 Basically the product is designed to not suffer functional disorders by Surrounding electromagnetic waves Notwithstanding strong electromagne tic waves may cause the product to malfunction This may include displaying incorrect calculation values disappearance of measurements and noises affecting the wave pattern If such errors continue contact the MEKICS Technical Service Center or authorized dealers for assistance If used by a patient with pace maker a professional individual with all required expert knowledge must operate the product Electromagnetic waves generated from an MRI device may influence the measurement values of the product MEKICS Co Ltd 2 System Outline 2 System Outline 2 1 Ventilator Configuration Setting values of the ventilator can be configured using touch pad key or encoder Parameters related to ventilation are always measured and can be adjusted Gas supply can be controlled to obtain objective values flow volume and pressure through difference between actually measured parameters and setting or c
60. ince Operation becomes triggering unstable by auto Since WOB can be increased or optimized Vmin must be managed using new training and based on decision of patients guidelines compared to existing modes Optimization of respiratory gas concentration and gas concentration in blood through monitoring can be difficult compared to general modes limitation in conditions of adaptation to individual patients 44 MEKICS Co Ltd AutoVent Pressure TRIG B Kg PEEP cmH20 TRIGGER TYPE OFF 45 0 3 PLIMIT cmH20 FTRIG LPM 100 75 20 0 3 0 10 0 5 ENSENS 2 30 EXSENS 2 o 30 The following parameters are configured in AutoVent mode 1 PEEP cmH gt 20 Trigger Flow Trigger Pressure Trigger Setting lpm cmH20 Oxygen Concentration Pressure Limit cmH gt 0 Inspiratory Trigger Sensitivity Expiratory Trigger Sensitivity minVol Mask Mode DE DE oe w ON HEX Sense Status 1 Status 2 3 Status CMV No Trg CMV Trg Spont PS 6 13 SHFV Single High Frequency Ventilation High Frequency Ventilation was developed with the ideal of providing gentle breathing for every patient from newborn infants to seniors This mode is high frequency ventilation mode with single frequency Frequency range 2 20Hz MV2000 SU M Ventilator 6 Ventilation Mode and Function The adult case sets4 8Hz 240 480bpm and Infant case sets 10 15Hz 600 900bpm Select
61. iow the spontaneous breath is pressure supported Pu Sponta p V Pressure Support N Synchronized Transitions In all spontaneous breaths occurring in tBiLEVEL mode 1 5 cmH O automatically provided If user wants higher level pressure supports is of pressure support pressure support ventilation can be configured If the value of support pressure PEEP ow IS ventilation larger than PEEPycH pressure support corresponding to the difference occurring during spontaneous breath in PEEPricy State is provided This can be seen in the following figure When using tBiLEVEL mode spontaneous breath MV2000 SU M Ventilator 6 Ventilation Mode and Function can be supported at any time reducing fighting between the device and patient Therefore frequency of inevitable sedation can be reduced resulting in reduction of treatment cost and quicker recovery of the patient Also the patient s comfort can be enhanced by providing pressure support ventilation on all soontaneous breaths 6 10 PRVC Pressure Regulated Volume Controlled Ventilation Pressure Regulated Volume Control PRVC is a mechanical ventilation mode based on auto pressure control Constant volume is maintained through target volume and pressure limit setting The ventilator delivers a pre set Tidal Volume The pressure is automatically regulated to deliver the pre set volume but limited to 1 cmH 20 below the set pressure li
62. is configured Since pressure is maintained constant during inspiration flow pattern is shown in the form of ramp Plateau function cannot be used assures that the Control Pressure preset inspiratory pressure level is maintained constantly during the entire inspiration 37 MEKICS Co Ltd 6 Ventilation Mode and Function The preset pressure level is controlled by the ventilator The resulting volume depends on the set pressure level inspiration time and the patient s lung mechanical properties during each breath Since exhalation valve is active exhalation valve airway pressure control becomes more active and precise Accordingly exhalation valve is used to control increase in pressure caused by talking or coughing of the patient during inspiration It also allows the patient to spontaneously breathe If the pressure increases to the set upper pressure limit the expiratory valve opens and the ventilator switches to expiration 38 MV2000 SU M Ventilator MEKICS Co Ltd 6 6 V SIMV Volume based Synchronized Intermittent Mandatory Ventilation V SIMV is a mode that controls ventilation based on volume according to spontaneous ventilation mode of the patient In other words this combined control and pressure support spontaneous function allows for preset mandatory breaths synchronized with the patient s breathing Spontaneous ventilation is done using configured time period or mechanical
63. ivers 100 oxygen for 3 minutes Key lock Key amp Touch Lock Graph freeze Freezes waveform amp loop graphs Alarm silence Turns off alarm sound for 2 minutes Alarm reset Clear active alarms X Measurement Condition 1 2 Pressure A 1 7 4 of the actual reading cmH2O Volume A 15 Tidal Volume gt 100ml B 20ml Tidal Volume lt 100ml Rate A 2 bpm O2 A 3 Inspiratory Time A 10 69 MV2000 SU M Ventilator MEKICS Co Ltd 12 Summary of Screen Usage 12 Summary of Screen Usage 12 1 Fixed Keys IF h Stondby 1 On Off Switch Standby To turn power ON push this button for 0 5 second To turn power OFF push this button during VENT mode operation for 10 seconds If the device is not in operation power is turned OFF by pushing for 5 seconds The device enters stand by mode by pushing the button during VENT mode operation 2 Manual Inspiration Inspiration is manually carried out once using current setting values by pushing this button 3 O2 100 100 oxygen is supplied for three minutes by pushing 100 O key Concentration is automatically returned to original oxygen concentration after three minutes If O2 100 button is pushed again during three minutes of 100 oxygen supply 100 O supply is terminated and original concentration is returned 4 Encoder Rotate the encoder to select wanted menu or wanted setting value Sub menu is selected or settin
64. low is provided to the patient Pressure is maintained between sensitivity setting value and pressure level 1 cmH2O below sensitivity setting Once pressure becomes 1 cmH gt 20 larger than PEEP exhalation valve is opened to begin expiration If the patient falls in apnea during SPONT mode Apnea Alarm is created by the device and Apnea Ventilation V ACV mode or P ACV mode is automatically started This Apnea Ventilation is operated according to items configured by user The mode returns to Spontaneous Mode if the patient shows two spontaneous breaths in 10 seconds 6 9 tBiLEVEL Spontaneous Ventilation tBilevel is pressure controlled breathing that allows the patient the opportunity of unrestricted spontaneous breathing Two pressure levels are set together with the individually set duration of each can be level Spontaneous breathing efforts assisted by pressure support MV2000 SU M Ventilator 6 Ventilation Mode and Function IBILEVEL Pressure TRIG PEEP HIGH cmH20 fl RESP R BPM TRIGGER TYPE 45 6 Of OFF PEEP LOW cmH20 TRISE sec FTRIG LPM 7 0 5 20 0 I 0 1 0 5 PSUPP cmH20 TRISE PSY sec ExSENS 60 0 5 80 D 0 1 10 PPS UPPER cmH20 TH PEEP sec 60 3 0 I 1 2 The following parameters are tBILEVEL mode 1 High PEEP Time sec Respiratory Rate b min High PEEP cmH gt 0 Low PEEP Base Pressure cmH gt 0 Oxygen Concentration configured in Expiratory Trigger Sensitivity
65. may cause damage on the product Appendix 2 4 3 Rinsing After Sterilization Rinse sufficiently with water to remove all disinfectants from parts Clean parts in running water Turn upright shake horizontally and tilt Repeat the above step at least 5 7 times AN ATTENTION Chemical precipitates may influence the patient induce leakage or damage parts Appendix 2 4 4 Drying Method Expiratory cassette must be dried before use Dry the cassette using the following method Repeat shaking and tilting of expiratory cassette 5 7 times Dry expiratory cassette in a dryer of up to 70 C 158 F for one hour If there is no dryer air dry expiratory cassette for 12 24 hours 79 MEKICS Co Ltd AN CAUTION Since inside of expiratory cassette can be damaged do not dry expiratory cassette using high pressure gas DS note If drying process is carried out by cleaning sterilizer no separate drying is required Appendix 2 5 Assembly Assemble expiratory cassette in the reserve sequence as disassembly AN WARNING Make sure that expiratory cassette makes clicking sound during assembly After cleaning and sterilization record it in a log according to the hospital s regulation Once assembly is complete perform pre use check using test lung If the product does not operate properly re check assembly of expiratory cassette and verify connection of tubes
66. mit PRVC assures a set target minute ventilation to the patient The target volume is based upon settings for Tidal Volume frequency and inspiration time The inspiratory pressure level is constant during each breath but automatically adapts in small increments breath by breath to match the patients lung mechanical properties for target volume delivery 42 MEKICS Co Ltd Pressure TRIG PEEP cmH20 TRIGGER TYPE PLIMIT cmH20 TINSP sec 0 75 E TRISE sec i 0 2 The following parameters are configured in PRVC mode Tidal Volume ml Inspiration Time sec Respiratory Rate b min PEEP cmH gt 20 Oxygen Concentration Inspiration Rise Time sec Trigger Flow Trigger Pressure Trigger Setting lpm cmH20 L p ME r eS YS LY Pe Pressure Limit cmH gt 0 10 Mask Mode On Off Despite advantages of pressure mode instability of not guaranteeing inspiratory volume caused by long term or acute change in patient s respiratory status or long term change in lung compliance is removed The ventilator delivers configured tidal volume Pressure maintained for supply of configured tidal volume is automatically adjusted within the range of pressure limit The first breath of a start sequence is a volume controlled test breath with pressure of 16cmH 0 The measured pause pressure of this breath is then used as the pressure level for the following breath MV2000 SU M Ventilator 6 Ventilation Mode and
67. n The following parameters are configured in VACV mode Tidal Volume ml Respiratory Rate b min Pause Time sec PEEP cmH gt 20 Oxygen Concentration Inspiratory Time sec End Flow Inspiratory Trigger Sensitivity Seo eS NE eS PY o Trigger Flow Trigger Pressure 10 Trigger Setting lpm cmH gt 20 11 Sigh Mode 12 Mask Mode On Off The airway pressure is dependent on the tidal volume inspiration time and the resistance and compliance of the respiratory system The set tidal volume will always be delivered An increase in the resistance and decrease in compliance will lead to an increased airway pressure To protect the patient s lungs from excessive pressure it is very important to set the upper pressure limit to a suitable value It is possible for the patient to trigger extra breaths if they can overcome the pre set trigger sensitivity It is also possible for the patient by their own inspiratory efforts to receive a higher inspiratory flow and Tidal Volume during an inspiration than pre set 36 MEKICS Co Ltd During volume control ventilation peak flow is determined after configuration of tidal volume and inspiratory time Also in addition to the above two items end flow and plateau are items that influence peak flow Volume Control assures a preset tidal volume with constant flow during a preset inspiratory time at a preset frequency When the preset tidal volume is delivered and
68. nce during initial operation of product Remaining Remaining batey i5 minutes is 5 minutes If Oz is detected below 18 If O cell fails However screen only displays 21 or above 55 MEKICS Co Ltd 9 Supplementary Devices 9 1 MEKICS Humidifier VH 2600 Use of heating humidifier in treatment of patients can be beneficial by the corresponding Refer to user manual manufacturer for structure and usage of humidifier AS WARNING Heating type humidifier must be turned off when using nebulizer Failure to turn off may influence the particle size of absorption drug Unexpected increase in gas temperature may result from use of unauthorized humidifier AN CAUTION Since water can be formed in the tube when heating type humidifier is used water trap must be connected to expiratory tube line During operation water trap must be checked accordingly frequently and emptied AN ATTENTION Since use of soft tube with extremely high compliance can affect functions of the ventilator use tubes supplied by our company if possible Supplementary accessories connected to the patient s tube can influence patient pressure MV2000 SU M Ventilator 9 Supplementary Devices 9 2 EtCO gt Option End Tidal CO gt Concentration EtCO gt concentration as a graph sensor displays expiratory end CO As a device that consecutively measures EtCO gt concentration during expiration
69. neous breathing is not applied If higher than setting alarm limit If lower than setting alarm limit In case supplied gas pressure Is lower than 3psi or impurities are included in inlet filter If inspiratory flow is above 8Lpm and exp pressure below 3cmH20 is maintained over 10 seconds or over 8L is supplied If circuit is easily opened or PEEP bundle If tank pressure is over 10 seconds and under 10psi After failure of air supply gas gas supply is checked every two minutes for automatic recovery If tank pressure is over 10 seconds and under 10psi After failure of Oz supply gas gas supply is checked every two minutes for automatic recovery 54 MEKICS Co Ltd Occurrence Alarm Immediate Message Separate After three Circuit i consecutive Leakage HE respirations n Low Battery Immediate Voltage O gt Cell i Immediate failure MV2000 SU M Ventilator 8 Alarm Message Criteria Linked to leakage volume mL configured by user Used when the difference between insp volume and exp volume is larger than leakage volume configured by user Circuit leakage alarm occurs if difference between insp and exp volumes occurs during three consecutive respirations Note NIV and Spont mode do not apply If air gas and O gas are not supplied and tank pressure is under 5 psi If battery usage is under 5 minutes If there is no respiration during time for three respirations in Vent mode Note This om TT ET occur o
70. nnect the breathing circuit to inspiratory port and expiratory port Rotate the encoder and push Start menu to start calibration Analysis ends after a moment 4 9 6 EtCO gt Zeroing If the ventilator has EtCO2 module calibration is performed Rotate the encoder and push Start to start with EtCO2 calibration EtCO2 calibration is completed after a moment MV2000 SU M Ventilator 4 Operation Method 4 10 Separation of Ventilator from Patient In order to separate the ventilator and stop ventilation 1 Separate the ventilator from the patient 2 Push standby key to convert to standby mode 3 Once ventilation stops push Power button to turn off the ventilator 4 When power is turned off turn off the main power switch on the back of the main body 22 MEKICS Co Ltd 5 Monitor and Information Saving 5 1 Measurement Value Display Measurement and calculation values during ventilation are displayed This Section includes descriptions on screen display additional display window on measurement and calculation values and list of all values displayed 5 1 1 Measurement Value Screen Measured parameters and the following details are displayed on left side of the screen 1 Alarm Limit 2 If value lies outside upper and lower limits of Alarm Limit the value is displayed in red 3 If value cannot be measured it is displayed as 4 Parameters displayed on measurement value screen can be
71. ns Expiratory part of the ventilator and expiratory may be contaminated MEKICS Co Ltd AN CAUTION Device for prevention of dry lung tissues Such as disposable humidifier or humidifier must always be used Refer to installation guideline for ventilator system and options for accurate assembly When separating or transporting the ventilator or its parts refer to User Manual or request our company Always take care in transportation Be careful when handling tube connector and patient tube parts Use of support arm can reduce weight of tube inflicted on the patient Do not renovate or remove any part of the ventilator If the product is repaired after not following the uses described in this booklet our company IS not responsible for safe operation of ventilator MV2000 SU M MV2000 SU M Ventilator 1 Introduction 1 2 2 Cautions for Storage I WARNING 1 Do not store the product in a place exposed to humidity TE i iz 2 Do not store the product in a place exposed to directsunlight 3 Do not store the product in a place near a heating device Yj Nl 4 Do not store the product in a place with extreme thermal variation Proper Temperature range is 15 C 50C and humidity range is 10 90 Jf BAG 5 Do not store the product in a very humid place or in a place with poor ventilation 6 Do not install or place the product where it may fall or be dropped Do not
72. o 0 1 o gt mw 0 1 0 0 gt sm 0 1 0 0 gt som o 0 1 O gt ApneaBackup O 0 0 gt Mask Ventilation Non Invasive TCPL me f eo n o move eo f oe HFV SHFV DHFV O Stream with Nasal Cannula Hemo Dynamics with SpO gt and EtCO gt Proximal Sensor Adult amp Neonate Optional 14 MV2000 SU M Ventilator MEKICS Co Ltd Appendix 1 Introduction Unless specifically mentioned operation and information on MV2000 SU M ventilator shall be based on details of this User Manual This Annex describes sterilization and maintenance of the ventilator Caution and Warning Matters Important N WARNING The mark above is WARNING The mark warns users on precautions that may cause great or irrecoverable damage to devices and patients AN CAUTION The mark above is CAUTION The mark warns users on precautions that may cause damage to devices and patients AN ATTENTION The mark above is ATTENTION The mark indicates information and tips on for use and easy connection of components SVANNOTE The mark above is NOTE The mark describes relevant items and additional information Contents included in the note mark do not damage patients and devices MV2000 SU M Ventilator Annex 1 Introduction Overall Outline Since there are diverse sterilization methods by different medical institutions our company cannot p
73. o emo oms fo emo OFF O HIGH OFF 1 100 O LOW OFF 50 500 AIR LEAK i MV2000 SU M Ventilator Apnea 2 60 7 Alarm SpO gt HIGH OFF l OFF 1 optional 52 99 SpO gt LOW OFF l 81 optional 51 99 PR HIGH l 30 250 150 BPM optional PR LOW i 25 245 50 BPM optional EtCO HIGH i 0 10 0 mmHg 0 1 optional EtCO LOW OFF optional 0 9 9 INS HIGH l 0 10 0 3 0 mmHg 0 1 optional INS LOW OFF i OFF mmHg 0 1 optional 0 9 9 RESP HIGH i 3 150 30 BPM optional RESP LOW i 2 149 5 BPM optional 51 MEKICS Co Ltd 8 Alarm Message 8 Alarm Message 8 1 Introduction This Chapter describes alarms and measures on each alarm message DS note Contact service assistant for most of technical errors A WARNING When conducting an act that can bring risks to the patient such as replacement of O2 cell always separate the ventilator from the patient AN CAUTION When the ventilator Is in operation do not raise or separate expiratory cassette However It may be separated in standby mode 02 MV2000 SU M Ventilator MEKICS Co Ltd 8 Alarm Message 8 2 Alarm and Error Message When an alarm message occurs check current mode and settle the problem immediately Occurrence Alarm _ Immediate Criteria Message Separate i la After apnea Only operated in Spont mode nea time If there is no respiration within configured apnea
74. occlusion nearby the sensor When the patient is experiencing cardiac arrest or shock Heart rate may be inaccurate in the following situations When sensor is tightened too much When sensor receives excessive medical light bilirubin light or sunlight When measured with pressure bandage or at a spot pressured by cuffs The sensor may show performance problems when exposed to excessive medical light especially xenon light bilirubin light fluorescent light infrared heating device or direct sunlight In MV2000 SU M Ventilator 9 Supplementary Devices order to prevent excessive light follow the instructions for use Use opaque substances to prevent the sensor from being exposed to external light sources Computed values may become inaccurate if surrounding environment is too bright Since movement of the patient can cause problems check whether the sensor is being operated safely Adhesive type sensor can be used to reduce measurement errors from patient s movement 9 3 1 SpO2 Connection Method 1 Connect SpO sensor cable to the socket on which SpO label is attached on the right side of MV2000 SU M ventilator 2 Place a finger on the SpO gt sensor 3 Wait for a moment until SpO gt measurement values are displayed as a graph 08 MEKICS Co Ltd 10 Initial Screen Configuration 10 1 Introduction When MV2000 SU M ventilator is operated it is operated in stand by mode User can con
75. ock Y piece and operate the product Check for tube leakage 3 Operate the product after connecting test lung to Y piece Check the status of patient tubes and ordinary operation 4 3 Patient Information Input VE TIDAL mL PEEP cmH20 PPEAK cn System RESP R BPM B0000 0000 Cm a e Some Graphics Tools Events Alarms YI TIDAL RESP R TPAUSE TINSP 1 Select system menu on the bottom of user interface 2 Enter patient menu In input window of the patient information the following information can be entered or modified 3 Bed number 4 Patient ID number 5 IP address for communication external connection using LAN 6 Port number for communication external connection using LAN 7 Password password 77 for IP and port input 19 MEKICS Co Ltd After completion of input and modification return to stand by screen and enter the patient s height Body weight and setting values for each mode are defined based on internal calculations DS note Input and modification can be done using the same method as setting configuration using touch screen Encoder can also be used 4 4 Ventilation Mode and Parameter Setting Ventilation Mode and Parameter Setting 1 Push Mode 2 Select the mode to use in the activated ventilation mode window Once a ventilation mode is selected parameters required for the selected mode are displayed 3 Select parameters for which values
76. on Time sec Respiratory Rate b min PEEP cmH20 Oxygen Concentration a oe W YS pP Inspiration Rise Time sec MV2000 SU M Ventilator 6 Ventilation Mode and Function Inspiratory Trigger Sensitivity Expiratory Trigger Sensitivity Trigger Flow Trigger Pressure 10 Trigger Setting lpm cmH20 11 Trise Pressure Support cmH20 12 Pressure Support cmH gt 0 13 APNEA sec 14 Mask Mode On Off 6 8 SPONT Spontaneous Ventilation This mode provides pressure support based on spontaneous ventilation If there is no spontaneous ventilation for configured time while operating in this mode mode is automatically converted to the mode V ACV or P ACV configured in Apnea Backup Mode returns to spontaneous ventilation once the patient breathes three times spontaneously in 10 seconds Pressure TIME TRIG PSUPP cmH20 TRISE PS sec TRIGGER TYPE 60 0 5 gt 5 Es 0 2 FLOW PEEP cmH20 APHEA sec 2 APHEA MODE V ACV MASK OFF The following parameters are configured in SPONT mode 1 PEEP cmH gt 20 2 Oxygen Concentration 3 Inspiratory Trigger Sensitivity 4 Expiratory Trigger Sensitivity 5 Trigger Flow Trigger Pressure 6 Trigger Setting lpm cmH gt 20 40 MEKICS Co Ltd Pressure Support cmH gt 0 Trise Pressure Support cmH20 Apnea Mode V ACV P ACV 10 Apnea Time sec 11 Mask Mode On Off Once the patient s intention for spontaneous ventilation reaches sensitivity f
77. order to settle 4 Push Accept to operate new setting values AN ATTENTION i i Do not use sharp tools to use touch screen Proximal Displays whether a proximal sensor is connected 10 MV2000 SU M Ventilator MEKICS Co Ltd 2 3 2 Encoder Setting Ventilator Setting Using Encoder 1 2 3 4 5 6 Rotate the encoder to find wanted menu Select by push the encoder Once activated Blue frame is turned white and values can then be changed Rotate the encoder to find wanted value Push the encoder again or touch activated parameter window again in order to settle adjusted value When parameter turns blue new setting has been saved Push Accept to operate new setting values and Cancel to cancel MV2000 SU M Ventilator 2 System Outline 2 3 3 Fixed Keys CD ri Ci EF 43880533 User interface has the following fixed keys 1 On Off Switch Standby 2 Manual Inspiration 3 O 100 4 Encoder 5 Exit 6 Run 7 Alarm Silence 2min 8 Alarm Reset AN ATTENTION When using special vent function user must always monitor the patient carefully 11 MEKICS Co Ltd 2 3 4 Direct Access Button Bottom of user interface has direct access buttons that can directly adjust 6 setting parameters to each button is Parameter corresponding automatically selected based on ventilation mode Direct Access Button Use
78. ort for respiration Delivered volume is monitored and inspiratory pressure is automatically adjusted as necessary Patient decides the number of respirations and inspiratory time Flow is delivered using decelerating method 5 Pressure Support PS Supported ventilation by pressure method Supported ventilation is delivered based on configured pressure level according to the patient s effort for respiration Patient decides the number of respirations and respiration time Flow pattern is delivered using decelerating method MV2000 SU M Ventilator 6 Ventilation Mode and Function Pressure Pressure and Volume Flow Volume Pressure 6 Spontaneous Breathing If the patient obtains sufficient volume in volume support spontaneous breathing can be permitted without support by the ventilator 7 Spontaneous breathing CPAP Spontaneous breathing through maintenance of positive airway pressure Spontaneous breathing of the patient occurs when inspiratory pressure level is configured as zero in pressure support O Stream Spontaneous breathing on a set flow level High flow The flows that exceed patient demands at various minute volumes O Stream affects CO efficient work of ventiatlion oxygenation breathing and energy cost of gas conditioning AutoVent The ventilator continuously adapts to the patient s breathing capability and allows the patient to better interact with the v
79. ote When patient type is changed the following default values or setting values are changed Default alarm values Alarm setting range Default parameter values Parameter range DS note Default values of the ventilator system on adults and infants can arbitrarily be changed by user DS note Always check alarm setting after changing the range of patient 4 8 Change in Setting Parameter In order to change setting parameters during ventilation push the speed button To adjust parameters of ventilation mode 1 Activate the parameter by touching the wanted speed button 2 Configure wanted value using encoder 3 Touch again to deactivate DS note New setting values are applied after deactivation of corresponding parameter button MV2000 SU M Ventilator 4 Operation Method 4 9 Measurement Sensor Calibration If the ventilator is continuously used for long time measurement values may slightly differ Measurement sensors must be calibrated Calibration of measurement sensor 1 Select system in the menu on the bottom of user interface Select Cal among sub menu 2 The following sensors must be calibrated Flow Zeroing Flow Sensor Offset Exp Flow Gain Expiratory Flow Sensor Balance Adult Prox Flow Gain Adult Proximal Flow Sensor Balance Neo Prox Flow Gain Neonate Proximal Flow Sensor Balance O Cell Cal O Sensor Leak Test
80. power source out of the rated power input Only authorized personnel who are trained to service the product may disassemble the product Note that neither the company nor any representative of the company will be responsible for any electric shock short circuit or product damage caused by unauthorized disassembly Failure to comply will cancel the product warranty and make the product ineligible for service MEKICS Co Ltd 1 Introduction If the power cord or sensor cable is 1 2 5 Precautions for Electronic Safety damaged immediately stop using the This product acquired electronic safety standard product and replace the power cord or CLASS II A cable Using the product when the power cord or sensor cable is damaged may cause an electric shock short circuit current leakage or product damage Do not bump or move the product while the power cord or sensor cable is connected to it This may cause patient injuries or product malfunctions When using the product with other devices use a separate AC power source for the other devices to ensure the patient s safety Do not use an anti electrostatic or conductive tube for the product Auxiliary equipment and accessories provided by MEKICS are qualified items that meet electrical safety standards The use of other companies products or unproven items may cause injury to the patient or product damage AN CAUTION 1 Only use auxiliary equipment provided by t
81. ressure Limited Assist Control A peak inspiratory pressures is set by the operator and during inspiration gas flow is delivered to hence the term achieve that set pressure pressure limited PL MV2000 SU M Ventilator 6 Ventilation Mode and Function The volume of gas delivered to the patient in this TCPL varies depending on pulmonary mechanics such as compliance of stiffness of the lungs At low compliance stiff lungs such as occurs early in the course of respiratory distress syndrome RDS a given pressure generates lower tidal volume TCPL AC Flow Pressure TIME TRIG FLOW LPH PEEP cmH20 RESP R BPM TRIGGER TYPE 180 45 46 s JO 34 204 FLOW PINSP cmH20 100 TINSP sec FTRIG LPH 30 fi 1 08 3 0 EnSENS w 30 The following parameters are configured in TCPL AC mode Flow lpm Respiratory Rate b min PEEP cmH gt 20 Oxygen Concentration Inspiratory Pressure cmH gt 0 Inspiratory Time sec Inspiratory Trigger Sensitivity Trigger Flow Trigger Pressure O w NDA SS Ye Pe Trigger Setting lpm cmH20 10 Mask Mode On Off The following case shows pressure and flow changes according to time when high flow and low compliance 46 MEKICS Co Ltd Pressure Limit er NT EET EE 5 OED VERE T Time Inspiratory Peak Flow The following case shows pressure and flow changes according to time when low flow and high compliance It cant be to reach the
82. ronrnreronnsrerrnnserenreenerrereneseneneereneseenenesreneneereneseevenessenenesvenessevenesvene 74 Appendix LATIN 75 Appendix 2 Cleaning Sterilization oo ccc cccsssssssesessesssesssesessessssesecsescssesussesessesessesssesesseaessseeeseaeeees 77 Appendix 2 1 Summary of Cleaning Sterilization Process nrnnvsnvrnrrvrrvrnsrvrvensrvrrvensrvrrsensesersenenn 77 Appendix 2 2 Preparation Disassembly nvrnrrvrnrvrnsrvonsrvrnsrvensrnensrnensrnensrnensrnensrnensenessrnensenensenensenensenenee 77 Appendix 2 2 1 Preparation m uce everevesvsvnssnssssnesnssnesessrssrsseesrssessesesrssesesrsresrssesessesessesesee 77 Appendix 2 2 2 Expiratory Cassette Separation us rvvmsvssnssnssssssssesessssessesseesee 77 MV2000 SU M Ventilator MEKICS Co Ltd Table of Contents Appendix 2 3 Wiping 7 DISPOSA sserrep nea sa a oro ieper ta oeeaaeaii 78 Appendix SLN 78 Append 2a DEPO a E EE EN 78 Appendix 2 3 3 Cleaning Before Sterilization ur ernmvsnvsvsvssevseesesee 78 Appendix 2 4 Sterilization Process rrrmmmmrmnvmnsvmnsvnssnssnsenssnsnssnssnssnssssnssssssrsesesee 79 Appendix 2 4 1 Cleaning Sterilizer nr nvnvrsnvvnsvnssnesssssssessessessesseesessesesrseseeseseesese 79 Appendix 2 4 2 Disinfectant se mceneeeeceveessesseseseseeseseeseesereensnn 79 Appendix 2 4 3 Rinsing After Sterilization nr eennvnvvsvveveseeere 79 Appendix 2 4 4 Drying Method n cccccccscssessssessssesessesesses
83. rovide a specific sterilization method that satisfies all medical institutions In addition our company is not responsible for the effects of sterilization process performed while configuring patient treatment Our company recommends using devices and methods described in this Annex Unless certified by our company we do not guarantee compensation for damages in the device or parts using methods not recommended here AS CAUTION All users must always be aware of risks of contaminated parts when separating and cleaning the ventilator All disposable parts must be handled according to disposal method of each hospital or disposed using eco friendly methods 75 MEKICS Co Ltd Annex 1 Introduction AN ATTENTION When handling ventilator parts follow infectious substance management guideline by each hospital If possible immediately clean the device after use Always clean before sterilization or disinfection When drying make sure there are no blood and Impurities on parts and device Water quality may influence cleaning and sterilization Our company recommends use of drinking water quality as minimal water quality Our company recommends use of bacteria filters or equivalent devices in order to reduce spread of bacteria from patients to expiratory cassette Use of such filters and devices can reduce risk of infection Lifespan of the product can be extended by reducing cleaning process of expiratory casset
84. rsrnersrversrnrversenenersenensrsenensrsenensenensrsenessrsenensrsensnsrsenensenesessenessrsensne 64 UNS 64 11 4 Ventilation Modes ccc cae cscs sect 64 11 4 1 Controlled Ventilation wc eeccsssesessssessessssesssssssecsssessecscsessssssssssecsssessecnssessesessesseceseesceeeseesseeesseneeeeseens 64 11 4 2 Supported Ventilation msnvavvvrvvrsesrsensrsersrsersrsrrsrsersrsersesersessrsessrnesersensrnessenensrnessrnessenessenessenessensnee 65 11 4 3 Combined Ventilation rversrersrsssrssssssesrsesssssesssssesrssssseseesesen 65 11 5 Communication Interface i usrrsrvrrvrvinsrsrsrsrsrsssrsrsssrssesrsssssesessessesesersersesseseesse 65 11 6 Service ee ee EET 65 11 7 ACcessones uusnanrasdkeddrasdnesnagsraedkendaandneggeagdkaggkemdsagdiadtmsdiadnghgddlse 65 11 8 Setting Parameter nmsnvrnnrvrvorsrvrvorsrvrnsrnrnrrsrnrvrsenversenensrnenensrnenensenensrsenenersensnssnenensenessrsensnsrsenensssesersenessrsensne 68 12 Summary of Screen Usage nsmnsrnsrvrnvrnsrvrvensrvsrvensrvsrvensrnsrvensensrvensensrvensensrvensensrsessenrsensenersesserersensesersessesersenenn 70 12 1 Fixed Keys nnnnvrnrrvrrrrvorrrvorrrverrrvervrvsrsrvrsersrsensrnensrsensrvensrsensrvensrnensrnensnsensrnensrnensrsensenensrnensenensenessenessenessenessenessensnee 70 12 2 Special Function Ke s Lvvvvv5v74v44v44vv4vr vever eske 71 123 MenO KEYS ea E E E E EE E E EE EE E EE een 72 124 sten FOER Ps 73 13 MV2000 SU M Series Features sosrsrrnrs
85. s automatically converted to 12V DC power battery Check charging status of battery frequently DS note Battery can be replaced if necessary even during the use of ventilator Also the ventilator can be used by connecting to an external 12V DC power Here similar to internal battery power source is automatically converted to external 12V DC power upon suspension of AC setting and stored power supply Ventilator information are preserved MV2000 SU M Ventilator 3 Power Supply 3 1 1 Power Supply Specification Rated voltage range 110 120V 220 240V AC 50 60Hz Internal battery Battery spec is 12V 7Ah External 12V DC power 12 0V 15 0V 10A battery for vehicles AN CAUTION When using external 12V DC power internal battery must be attached for safe operation of the ventilator Power Consumption 100 120 AC 84W max 50 60Hz 10A 200 240 AC 84W max 50 60Hz 5A 3 1 2 Battery Information Summary Battery Life Since Manufacture Date Operation Time About 3 hours if used continuously Charging Time About 4 hours Storage Temperature 15 20 C 59 68 F Individual Storage 3 2 Battery Status Display Screen When the ventilator is operated using battery remaining operation time of the battery is displayed on the bottom right corner of the screen 16 MEKICS Co Ltd 3 Power Supply Long term storage may cause reduction in When battery state is low b
86. spiratory flow 5 End inspiratory flow 6 Peak expiratory flow 7 End expiratory flow Volume Time Waveform X Inspiration time Z Expiration time 8 Start of Inspiration 9 End Inspiration 10 End expiration 6 3 Setting Parameter Description 6 3 1 Trigger Function Trigger sensitivity determines the patient s effort during breath to induce ventilation from ventilator Trigger sensitivity can be configured using flow trigger FTRIG or pressure trigger PTRIG method In general flow trigger method can reduce the patient s effort for breath Trigger sensitivity should be configured as high as possible without resulting in self auto triggering Such setting increases patient triggered ventilation and reduces auto cycling by the ventilator Pressure trigger can be configured within the range of 0 5 20 cmH20 pressure trigger setting is also related to PEEP setting Flow trigger refers to the amount of bias flow that must be inhaled by the patient to induce new breath MV2000 SU M Ventilator 6 Ventilation Mode and Function AN WARNING The trigger sensitivity bar has different colors based on the setting light blue bar indicates a normal setting for flow A red bar indicates that triggering IS required for flow The ventilator continuously delivers a gas flow during expiration which is measured in the expiratory channel 1 Inspiration Bias flow during expiration is 8 min
87. t is firmly fixed to prevent movement during transportation 2 5 2 During Transportation Check the following matters before transporting the ventilator whether the ventilator is connected to a patient or not Use the handle on the main body Move slowly the bed and ventilator During transportation be careful about pulling or movement of tubes connected to the patient When moving or changing location of support arm be careful about pulling or movement of tubes connected to the patient When passing through obstacles such as door threshold be careful not to tilt the mobile Cart 2 5 3 Transportation Between Hospitals MV2000 SU M ventilator can be used during transportation of patients between hospitals 2 5 4 Storage MV2000 SU M Ventilator 2 System Outline When storing ventilator always connect to main power source for battery to be charged sufficiently Do not discard battery and O2 cell with ordinary wastes Do not expose the ventilator to a temperature below 15 C 5 F or above 50 C 122 F Do not expose the ventilator to a relative humidity above 90 15 MEKICS Co Ltd 3 Power Supply 3 1 Outline MV2000 SU M ventilator has auto transition function for rated voltage The ventilator automatically adjusts to 100 120 AC or 220 240 AC power To prevent damages in ventilator setting and stored information upon suspension of AC power main power supply power source i
88. te 16 MV2000 SU M Ventilator MEKICS Co Ltd Appendix 2 Cleaning Sterilization Appendix 2 1 Summary of Cleaning Sterilization Process This Appendix provides summary of cleaning sterilization and disinfection processes Cleaning process using bacteria filter Disassembly Wiping Disposal Assembly Cleaning process without using bacteria filter Disassembly Wiping Disposal Cleaning Disinfectant Sterilizer Cleaning Assembly MV2000 SU M Ventilator Annex 2 Cleaning Sterilization Appendix 2 2 Preparation Disassembly Appendix 2 2 1 Preparation Turn off the power of ventilator using switch button on the back of main body Separate main power and gas hoses from the ventilator Turn off the power of surrounding devices and separate them from the ventilator Appendix 2 2 2 Expiratory Cassette Separation Separate all silicon hoses connected to expiratory cassette After raising the lock handle pull the cassette bundle forward for separation TT MEKICS Co Ltd Cassette is separated by rotating the junction marked in the drawing below Disassemble the cassette as in the drawing Appendix 2 3 Wiping Disposal Appendix 2 3 1 Wiping Wipe ventilator and all parts using soft cloth with detergent or disinfectant A CAUTION Do not place battery EtCO gt module and Sp02 sensor in any solution DS note In case of severe de
89. the sequence 2 3 1 Touch Screen Setting EXIT Key Removes menu window from the screen RUN Key Used to run the ventilator using values in ventilator set Alarm 2MIN Mutes auditory alarm signal for two minutes AC Power Displays that the device is operating under AC power i i j j Ventilator Setting Method Battery check Displays that the device 1 Open ventilation mode setting window by is operating with battery as well as i N pushing ventilator mode Modes on top of er the screen Inspiration Hold Measures compliance and resistance by adding one second to 2 Push the parameter to configure and activate inspiration hold time Expiration Hold Auto PEEP is measured after maintaining expiration hold for two and values can then be changed seconds 3 Rotate the encoder to find wanted value Push Alarm Sound Off or Mute Displays the encoder again or touch activated alarm sound off or mute This can be turned on off using 2MIN key Touch Key Lock Keys on the touch adjusted value When parameter turns blue screen are locked by pushing key lock new setting has been saved They are unlocked by pushing again Freeze Freezes currently displayed graph In case of trend screen and Cancel to cancel encoder can be used to view saved trend values Adult Displays male female pediatric and neonate mode it Once activated Blue frame is turned white parameter window again in
90. tilation mode display 2 Alarm display and alarm message window 3 Ins Exp hold Adult amp Proximal sensor Icon 4 Date time and O 100 display 5 Nebulizer On Off display 6 Power supply AC green BATTERY orange Touch key lock unlock LE graph CAUTION When external 12V DC power is used insert normal battery for safe and internal operation MV2000 SU M Ventilator 2 System Outline 2 4 Patient Unit Connection Label Symbol Patient unit main body of the ventilator is composed of the following parts Gas supply and connection part Power supply and connection part Accessory connection part 2 4 1 Patient Unit Configuration Refer to the patient unit diagram on the next page to check for location of the following parts A Al Nebulizer Port A2 Inspiration Outlet A3 Expiration Outlet A4 Expiration Inlet A5 Handle for Moving A6 SpO2 EtCO2 Connector B B1 External Battery Port B2 Main Power Switch B3 AC Power Inlet B4 Ground Terminal B5 O gt Gas Inlet B6 Air Gas Inlet B Water Trap B8 Connector between Screen and Main Body B9 RS232 Communication Terminal B10 Tank Safety Air Relief B11 Battery Cover C C1 Safety Air Relief C2 Body Handle 13 MEKICS Co Ltd 2 System Outline 2 4 3 User Interface Symbol Power On Off These symbols are used in power switch I indicates power on O indicates power off IEC 601 1
91. to check for accurate operation Do not use one product on two patients simultaneously Do not use in places exposed to humidity It is extremely dangerous to use the product with wet hands Do not use the product under direct sunlight Do not use the product in places with large temperature fluctuations Temperature range is 10 C 40 C and humidity range is 10 90 MEKICS Co Ltd Do not use the product nearby electric heating devices 12 Do not use the product under high humidity or ventilation problem 13 Do not use the product in places with excessive impact or vibrations 14 Take care to prevent dusts especially metal substances from entering the product A CAUTION 1 This product is used to determine patient status Other clinical information must be used together for accurate diagnosis 2 Take care not to cause pain on patients from tightening of sensors Also take care not to tangle patients with sensor cables 3 If measurement values displayed on the screen are considered inaccurate measure another patient for comparison MV2000 SU M Ventilator 1 Introduction 1 2 4 Precautions for Electric Safety WARNING The rated power input for this product is AC 100 240V 10A 50 60Hz Connect the power plug to an AC power outlet with an earth terminal Note that neither the company nor any representative of the company will be responsible for any issues arising from the use of any
92. to predict pCO CO concentration in blood the sensor is an important means to monitor appropriate inspiration and expiration states Also since the sensor is a means to determine respiratory diseases such as asthma based on extraction of various parameters from capnograph wave it Is also used for diagnosis AN WARNING Only use CO2 components certified by our company 9 2 1 EtCO gt Connection Method 1 Connect EtCO sensor cable to the socket on which EtCO gt label is attached on the right side of MV2000 SU M ventilator 2 Connect the EtCO gt sensor to the patient 3 Measurement values are displayed by selecting EtCO gt graph from Graph Selection menu 56 MEKICS Co Ltd 9 2 2 EtCO gt Calibration 1 Select System in the menu at the bottom of user interface 2 Select Calib menu among System menu 3 Perform EtCO gt calibration in Calib menu 9 3 SpO gt Option Pulse Oximeter Oxygen Saturation Oxygen saturation shows the degree of concentration of hemoglobin that transports oxygen in the artery That is it displays the degree of currently transported amount compared to oxygen transportable by hemoglobin as a percentage It does not show the amount of carboxyhemoglobin or methemoglobin hemoglobin from hemoglobin disorder N WARNING Only use SpO sensor certified by MEKICS If a different product is used there may be a problem in performance Only use SpO sensor certifie
93. trigger sensitivity tidal volume is delivered from the ventilator Timing Timing in controlled ventilation mode is determined by configured time Timing in supported ventilation is decided by the patient s effort for ventilation and configured inspiratory cycle off MV2000 SU M Ventilator 6 Ventilation Mode and Function 6 1 4 Summary of Ventilation Modes Pressure Pressure and Volume Pressure Flow Time Volume Pressure 1 Pressure Regulated Volume Control PRVC Volume control ventilation by auto pressure control While controlled ventilation is delivered at constant maintaining configured tidal volume inspiratory pressure for each breath depending on the lung status of the patient Flow is delivered using decelerating method 2 Volume Control VC Controlled ventilation by volume method While mechanical ventilation is delivered using constant maintaining configured tidal volume flow pattern method 3 Pressure Control PC 30 MEKICS Co Ltd Controlled ventilation by pressure method Mechanical ventilation is delivered using decelerating flow pattern method according to configured pressure level Pressure Pressure and Volume Flow Volume Pressure Pressure 4 Volume Support VS Volume support ventilation method by auto pressure control Supported ventilation is delivered by constant inspiratory pressure according to the patient s eff
94. use check prior to connecting the ventilator to the patient Do not connect the ventilator to the patient in case of functional errors When ventilator is in operation do not raise or separate expiratory cassette If necessary take these actions in standby mode or with the ventilator turned off 4 2 1 Start Up 1 Connect power and gas supply line AC power Air O2 gas 2 Turn on the ventilator 18 MEKICS Co Ltd 3 The ventilator will inspect system function status pressure sensor flow sensor and gas supply Status 4 Once inspection is completed the stand by screen will appear 4 2 2 Auto transition Between AC Power and Battery Power During pre use check auto transition between AC power and battery power from suspension or reconnection of AC power supply must be tested Check icon on the screen to see whether the ventilator is in AC mode Unplug the AC plug to block power source Check whether icon is changed to battery mode If there is no problem in icon change reconnect the AC plug AN CAUTION If the product is turned off during transition to battery mode re inspect after charging or replace the battery MV2000 SU M Ventilator 4 Operation Method 4 2 3 Tube Inspection for Patients 1 Connect patient tubes including humidifier and nebulizer If humidifier is used water tank in the humidifier must be filled with distilled water 2 Bl
95. versrvsrversessrversersrvensensenensersrvensensrversenervessenersesseversessesersesseverssnee 16 3 2 Battery Status Display Screen cccccesssssssessssesesscsessssesscsesscsessssesscsecsesessesecssseessseeeeseeseseeeseeneaee 16 3 3 Alarm and Safety Devices cccccccsessessssssssssssessessssesssssssessesussessssucsessssussessssussessssucsessesecseeseseeseeseaeeseens 17 385 NN dene 17 3 3 2 AG Power SUD Tre 17 4 Operation Method menvrnrvrnrrvrnsrvensrvensrvensrnensrnensrnrsenensenensenensenensenensenensenensenessenensenensenensenensenensenessenessenensenessensnee 18 4 1 Operation Sequence Summary mvrsnvnssnnssnenssnensnesnesnesnssessrssesrssrsesesesereesrsersesene 18 4 2 CE T 18 ES Go EEE 18 4 2 2 Auto transition Between AC Power and Battery Power mmmsnrensrssrsrssrsrvsrvrsernessnvessrnessrsessenessenenee 19 4 2 3 Tube Inspection for Patients nrsnrvrssvnssvnsveeeessessessesessesesseseesessen 19 4 3 Patient Information Input Luvusversensenernaenmmnemnemnemnumehiehmnn nn 19 4 4 Ventilation Mode and Parameter Setting osnvrnsrvrnrrvrnsrvrnsrversrvensrvensrvensrnersrnersnnensnnensenensenensenensensnee 20 4 5 Alarm Setting SNE 20 4 6 Starting Vertilation uc cc csesssssesesscsessesessssessssessssessesecsssesussesussesucsesusseauesesucsesseseseesesesseseeseaesseeeeaes 20 4 7 Change in Patient Type ou cccscssssssssesssesssessssessssessssecscsessssesucsesscsesussesussesussessesecuesesesesesseaeeseeeeaes 20
96. vice must be carried out by an experienced expert trained by our company A S on the device must be carried out after separating the ventilator from the patient AN CAUTION Only use parts supplied by our company 11 7 Accessories 11 7 1 Standard Accessories High Pressure Hose Air Gas Yellow P N 141400020 O Gas Green P N 141400030 Display Panel Cable P N 142401900 65 MEKICS Co Ltd O Cell P N 140500660 Installed inside PEEP Silicone Plate P N 140601420 Test Lung P N 140602600 Power Cord P N 140600530 3m 220VAC Fuse P N 141300170 Inlet 50T 6 3A 250V 20mm MV2000 SU M Ventilator 11 Technical Specification Wrench Driver P N 140800720 Circuit Arm Fix Knob P N 140403490 a 53010 O Ring P N 142100400 O Ring for PEEP Module Q 53030 O Ring P N 142100410 O Ring for PEEP Module Monitor Fix Bolt P N 140800330 M5x12mm Wrench Bolt For Monitor Body Cover P N 150000160 66 MEKICS Co Ltd MV2000 SU M Ventilator 11 Technical Specification 67 MEKICS Co Ltd 11 Technical Specification 11 8 Setting Parameter Setting range Default Predicted Body Weight 150 kg Tidal Volume 5 ml 2500 ml Inspiratory Pressure 5 80 cmH20 Pressure Support 0 60 cmH20 5 cmH20 Respiratory Rate 2 150 bpm Inspiratory time 0 2 9 9 sec gt Plateau Time i 0 2 sec 0

User`s Manual MV2000[SU:M] Ventilator System 0470

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