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E-1

E. Compliance

E. Compliance

IEC Standard

EN Standard

Designation

IEC 60601-1

EN 60601-1

General requirements
for basic safety and
essencial performance

IEC 60601-1-2

EN 60601-1-2

Electromagnetic
compatibility

IEC 60601-1-6

EN 60601-1-6

Usability

IEC 62366-1

EN 62366-1

Usability

IEC 60601-1-8

EN 60601-1-8

Alarm systems

ISO 80601-2-55

EN ISO 80601-2-55

Repiratory gas
monitors

ISO 14971

EN ISO 14971

Application of risk
management to
medical devices

ISO 80601-2-12

EN ISO 80601-2-12

Critical care ventilators

Содержание iHope RS Series

Страница 1: ...iHope Ventilator User Manual RS Series...

Страница 2: ...ecial functions The RS100 is the cut off model of RS300 without single limb ventilation modes The RS NEO provides a full ventilation platform with target volumes for extremely low birthweight patients...

Страница 3: ...hysical Description 2 2 2 4 1 Front View with Circuit 2 2 2 4 2 Main Unit 2 4 3 Installations and Connections 3 1 3 1 Installing the Support Arm 3 1 3 2 Installing the Patient Tubing 3 4 3 3 Installin...

Страница 4: ...or Exit Freeze Status 4 10 4 6 2 View Frozen Waveforms or Loop 4 10 4 7 Screen Capture 4 11 4 8 Lock Screen 4 12 5 System Settings 5 1 5 1 Date and Time Settings 5 1 5 2 Screen Settings 5 1 5 2 1 Scr...

Страница 5: ...ion 6 1 6 1 Turning on the Ventilator 6 1 6 2 System Check 6 1 6 3 Select Patient 6 6 6 4 Ventilation Type 6 8 6 4 1 Invasive Ventilation 6 8 6 4 2 Non Invasive Ventilation NIV 6 9 6 4 3 Set Ventilati...

Страница 6: ...0 Turn the Ventilator Off 6 31 7 Alarms 7 1 7 1 Introduction 7 2 7 2 Alarm Categories 7 3 7 3 Alarm Priority Levels 7 4 7 4 Alarm Signals 7 4 7 4 1 Alarm Lamp 7 5 7 4 2 Audible Alarm 7 5 7 4 3 Alarm M...

Страница 7: ...ure 7 18 7 12 8 Low Pressure 7 18 7 12 9 High Tidal Volume 7 18 7 12 10 Low Tidal Volume 7 18 7 12 11 Low Minute Volume 7 19 7 13 Alarm Troubleshooting Table 7 19 7 14 Alarm Parameter 7 30 8 Special F...

Страница 8: ...ation 9 10 9 6 Oxygen Concentration Calibration 9 12 9 7 Electrical Safety Inspection 9 14 10 Cleaning and Disinfection 10 1 10 1 Methods 10 2 10 2 Part Disassemble 10 6 10 2 1 Expiration Valve Assemb...

Страница 9: ...Parameters 11 10 11 7 Configuration Specifications 11 15 11 8 Factory Default Settings 11 17 11 9 Residual Risk 11 26 11 10 Other Technical Data 11 26 A Pneumatic Diagram A 1 B Parts and Accessories...

Страница 10: ......

Страница 11: ...Chapter 1 1 Safety Information 1 1 1 1 Safety Information 1 1 1 1 1 WARNING 1 1 1 1 2 CAUTION 1 8 1 1 3 NOTE 1 9 1 2 Symbols 1 10...

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Страница 13: ...ons are also inserted within the manual where they are most meaningful Notes are also located throughout the manual to provide additional information related to specific features 1 1 Safety Informatio...

Страница 14: ...isassembling or cleaning some parts of the ventilator can cause risk of infection Using the ventilator in the vicinity of high frequency electrosurgery equipment defibrillators or short wave therapy e...

Страница 15: ...e operate by two hands to prevent potential injury caused by sudden pressure release Do not block the air intake on the rear side of the ventilator To prevent interrupted operation of the ventilator d...

Страница 16: ...do not put a container filled with a liquid on the ventilator To reduce the risk of fire use the ventilator in well ventilated areas away from flammable anesthetics Do not use in a hyperbaric chamber...

Страница 17: ...due to leaks around the mask during noninvasive ventilation We recommend that you set the leak alarm to detect and notify when a clinically significant leak occurs To prevent unintentional disconnect...

Страница 18: ...hildren s reach To prevent possible patient injury maintenance mode can only be used when the ventilator is disconnected from the patient Nebulization or humidification can increase the resistance of...

Страница 19: ...ed to position with symbol and other end is connected to equipotential system Use of potential equalization conductor together with a reference to requirements in clause 16 of IEC 60601 1 for Medical...

Страница 20: ...ries must be disposed of in compliance with the guidelines regulating the disposal of such products Grounding reliability can only be achieved when equipment is connected to an appropriate voltage rec...

Страница 21: ...If you detect any unexplained changes in the performance or visual displays of the ventilator discontinue ventilator use and contact your service providers Keep this manual close to the ventilator so...

Страница 22: ...gen cell batteries If you must ship the ventilator to prevent possible damage to the ventilator use the original packing materials If these materials are not available contact your servive providers f...

Страница 23: ...h the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive European Authorized Representative Dispose according...

Страница 24: ...Recyclable materials Attention consult accompanying section in the operator s manual Equipotentiality Fuse Power switch Battery Oxygen sensor connector Oxygen supply connector RS 232 connector HDMI co...

Страница 25: ...1 13 1 Safety Information Symbol Definition Nebulizer connector Proximal pressure port Alarm audio pause AC power indicator light Battery LED There is certain danger to block the air intake...

Страница 26: ...1 14 1 Safety Information For your note...

Страница 27: ...Chapter 2 2 General Information 2 1 2 1 Intended Use 2 1 2 2 Contraindications 2 1 2 3 Potential Side Effects 2 2 2 4 Physical Description 2 2 2 4 1 Front View with Circuit 2 2 2 4 2 Main Unit 2 4...

Страница 28: ......

Страница 29: ...l The ventilator is intended for use by qualified trained personnel under the direction of a physician and within the limits of its stated technical specifications 2 2 Contraindications The contraindi...

Страница 30: ...entilation include ear discomfort conjunctivitis skin abrasions due to mask patient interface and gastric distention aerophagia If skin irritation or breakdown develops from the use of the mask refer...

Страница 31: ...To minimize turbulence we recommend using smooth inner wall tubing Use a circuit listed in Appendix B or equivalent NOTE During single limb ventilation use of a filtered exhalation port is recommended...

Страница 32: ...xygen sensor listed in Appendix B Nebulizer VADI M 0801 EN 2 4 2 Main Unit Figure 2 2 through Figure 2 4 show the controls indicators and other important parts of the ventilator unit Figure 2 2 Front...

Страница 33: ...is operating on battery power Not lit Indicates that the ventilator is power off or that the ventilator does not have a battery installed or that there is a fault with the battery 5 Alarm Pause key Pa...

Страница 34: ...oxygen inlet connector See section 3 5 for more information 6 High pressure oxygen inlet connector See section 3 5 for more information 7 Air intake filter cover Allows intake of air for delivery to...

Страница 35: ...Network connector 13 HDMI connector Figure 2 4 Side view Table 2 4 Description of side view No Description 1 Inspiration connector to patient 2 Expiratory connector from patient NOTE This port is not...

Страница 36: ...2 8 2 General Information For your note...

Страница 37: ...Installing the Patient Tubing 3 4 3 3 Installing the Humidifier 3 8 3 4 Installing the Nebulizer 3 11 3 5 Connecting the Oxygen Supply 3 12 3 6 Installing the Gas Cylinder 3 15 3 7 Installing the Oxyg...

Страница 38: ......

Страница 39: ...ck the speakers To reduce the risk of electric shock from liquid entering the device do not put a container filled with a liquid on the ventilator Set up the ventilator for each patient use as describ...

Страница 40: ...Installations and Connections 1 Fixing block knob 2 Fixing block 3 Tube hook 4 Support arm joint 5 Support bar 6 Support arm joint 7 Support arm joint Figure 3 1 Installing the patient tubing support...

Страница 41: ...ownward with the other hand Release the white unlocking key after adjusting the support bar to the desired position Support arm joint 6 or 7 can be adjusted up to 130 Support arm joint 4 swivel upward...

Страница 42: ...uring noninvasive ventilation avoid introducing extra dead space to the patient circuit Adding accessories or other components to the breathing system of the ventilator can increase system inspiratory...

Страница 43: ...3 5 3 Installations and Connections 1 Inspiratory bacteria filter 2 Inspiratory tube 3 Exhalation port 4 Proximal pressure line Figure 3 2 Single limb without humidifier...

Страница 44: ...6 3 Installations and Connections 1 Inspiratory bacteria filter 2 Inspiratory tube 3 Humidifier 4 Water trap 5 Exhalation valve 6 Proximal pressure line Figure 3 3 Single limb circuit with humidifier...

Страница 45: ...tube 5 Humidifier 6 Water trap 7 Y piece 8 Flow sensor 9 Proximal pressure line Figure 3 4 Dual limb circuit with humidifier Properly position the patient circuit before use on a patient Make sure the...

Страница 46: ...of proximal pressure port is blue 3 3 Installing the Humidifier WARNING To prevent possible patient injury and equipment damage do not turn the humidifier on until the gas flow has started and is reg...

Страница 47: ...operation manual 1 Align the humidifier mounting plate and the slot and slide the humidifier in 2 Tighten the screw 3 Mount the filters onto the inspiratory and expiratory ports 4 Connect the inspirat...

Страница 48: ...late 3 Screw 4 Humidifier bracket slot 5 Humidifier outlet 6 Humidifier inlet Figure 3 5 Installing the humidifier The range of the ventilator breathing system VBS Inspiratory and expiratory gas pathw...

Страница 49: ...rcuit during nebulization Nebulization can cause an expiratory side filter to clog substantially increasing flow resistance and impairing ventilation Connect the nebulizer in the inspiratory limb Conn...

Страница 50: ...he Oxygen Supply WARNING Connect the ventilator only to an appropriate medical grade oxygen source Inspect the O2 supply connector carefully and make sure there is no leakage If gas leakage is signifi...

Страница 51: ...vent possible patient injury make sure that an emergency backup O2 supply for example a gas cylinder is available in case the low pressure O2 supply fails Do not connect the ventilator to both high pr...

Страница 52: ...ng ring is damaged do not use the hose and replace the sealing ring to prevent leakage 2 Align and connect the fitting to the inlet of the high pressure oxygen supply at the back of the ventilator 3 M...

Страница 53: ...gas cylinder 1 Place the gas cylinder onto the trolley base 2 Fix the gas cylinder via Hook Loop tapes 3 7 Installing the Oxygen Sensor This ventilator could be equipped with O2 cell O2 cell is a cons...

Страница 54: ...nnection cable 3 Install the O2 cell cover on to machine casing CAUTION To reduce the risk of explosion do not burn the O2 cell or force the cell open NOTE If ICU work normally the service life of O2...

Страница 55: ...d when equipment is connected to an appropriate voltage receptacle marked hospital only or hospital grade Connect the ventilator to an outlet that supplies AC power between 100 and 240V AC 50 60 Hz Al...

Страница 56: ...e intended for short term use only They are not intended to be a primary power source The ventilator comes with two backup batteries one mandatory and the other optional The backup batteries protects...

Страница 57: ...out symbol means not available Check the batteries charge level before putting a patient on the ventilator and before unplugging the ventilator for transport or other purposes If the ventilator is ru...

Страница 58: ...3 20 3 Installations and Connections For your note...

Страница 59: ...4 4 4 3 Loops Window 4 4 4 4 Values Window 4 5 4 5 Trend 4 6 4 5 1 Graphic Trend 4 6 4 5 2 Tabular Trend 4 8 4 5 3 Event Logbook 4 8 4 6 Freeze 4 10 4 6 1 Enter or Exit Freeze Status 4 10 4 6 2 View F...

Страница 60: ......

Страница 61: ...1 Screen Display 2 PM 12 46 01 56 2018 05 10 1 30 0 15 0 0 0 6 0 120 0 60 0 60 0 120 0 0 500 0 250 0 0 100 0 XXXXXXXXXX XXXXX XXXXX XXXXX XXXXX 19 3 459 462 1 2 0 6 28 5 1 1 2 3 4 5 6 7 8 9 10 11 15 1...

Страница 62: ...messages When there are multiple alarm messages the number of alarms is displayed Clicking the alarm message bar to view the alarm messages list 5 Prompt message field Displays the active prompt mess...

Страница 63: ...es the real time refreshing of waveforms and loop graphs on the screen so that you can review specific patient data 12 Ventilation mode setup field Displays the keys for setting up ventilation modes 1...

Страница 64: ...the waveforms window 30 0 15 0 0 0 6 0 120 0 60 0 60 0 120 0 0 500 0 250 0 0 100 0 Figure 4 2 Waveforms window 4 3 Loops Window Select the Loops key to access the screen as shown below The ventilator...

Страница 65: ...ure 4 3 Loops window 4 4 Values Window Select the Values key on the screen to open the interface as shown below The ventilator displays the numeric patient data on the screen You can configure the mai...

Страница 66: ...n the screen to view trend graphic trend table and logbook in the opened window Figure 4 5 Trend Log key 4 5 1 Graphic Trend Graphic trend records the trend of parameter values It is reflected through...

Страница 67: ...sor The corresponding time displays above the cursor 2 Alarm marker The dotted colored line indicates a parameter alarm event occurred at that time A parameter alarm event is indicated by a dotted lin...

Страница 68: ...Minutes 1 Hour and 2 Hours 2 Group You can set the displayed parameter group to Press Flow Volume Time Gas Others and All 4 5 3 Event Logbook The Event Log window shows the event log or data about cli...

Страница 69: ...isplays the most recent record at the top The system can store up to 20000 records of Event Logbook XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX X...

Страница 70: ...Freeze Status When in non standby status and non freeze status press the key will display the Freezing press Freeze key again to unfreeze prompt message on the screen and the system will enter freeze...

Страница 71: ...apture Ref key is disabled and you cannot save a loop as a reference loop However you can view reference loops that are already saved 4 7 Screen Capture By pressing the key on the main screen the syst...

Страница 72: ...keys on the main screen are disabled Touch screen control knob and other keys are disabled Press this key again to unlock the screen Figure 4 11 Screen lock ley XXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXX...

Страница 73: ...5 3 5 3 2 Patient and Setting Data 5 4 5 3 3 Transfer Settings 5 5 5 4 Basic Settings 5 7 5 4 1 Set T insp I E 5 7 5 4 2 Set VT IBW 5 7 5 4 3 Set IBW Height 5 7 5 4 4 Set IV Apnea Mode 5 7 5 4 5 Set...

Страница 74: ......

Страница 75: ...p menu 2 Set Date and Time 3 Set Date Format to YYYY MM DD MM DD YYYY or DD MM YYYY 4 Set Time Format 24 h or 12 h XXXXXXXXXXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX Figure 5 1 Date Time s...

Страница 76: ...XXXXXXXXXXXXXXXXX 54 26 Figure 5 2 Screen settings 5 2 2 Screen Layout 1 Select Setup System Screen Settings 2 Select corresponding icons to set the displayed number of waveforms and the value count 3...

Страница 77: ...les you can preview delete or export them The exported file is saved in bmp format To export screen capture 1 Insert the USB device into the USB connector of the ventilator The USB symbol key is highl...

Страница 78: ...ing parameters current alarm limits trend data and so on To export data 1 Insert the USB device into the USB connector of the ventilator The USB symbol key is highlighted on the main screen 2 By selec...

Страница 79: ...rt settings while unit is in standby To export settings 1 Make sure that the machine is in Standby status 2 Insert the USB device into the USB connector of the ventilator The USB symbol key is highlig...

Страница 80: ...Insert the USB device into the USB connector of the ventilator The USB symbol key is highlighted on the main screen 3 By selecting the USB symbol key the system will open the USB settings interface 4...

Страница 81: ...n VT IBW 5 4 3 Set IBW Height 1 Select Setup Vent Setting 2 Set IBW Height and toggle between IBW and Height When the ventilator is in the standby mode set the ideal body weight or height The system c...

Страница 82: ...tion of oxygen enrichment the system will compare current oxygen concentration oxygen enrichment with 100 vol and start ventilation according to the lower of the two values 5 4 6 Set Oxygen Sensor Mon...

Страница 83: ...from powering on the ventilator to reaching the oxygen concentration monitoring performance specified in this manual is approximately 30s The data sample rate of oxygen concentration is 100Hz CAUTION...

Страница 84: ...tem password System 2 Select Gas supply and select a desired Oxygen XXXXXXXXXX XXXXXXXXXX Figure 5 9 Oxygen supply settings window 5 4 8 Set Language 1 Select Setup System 2 Select Language and select...

Страница 85: ...XX Figure 5 10 Language settings windows 5 4 9 Set Unit Set Paw Unit 1 Select Setup Maintain Enter password System 2 Set Pressure Unit cmH2O hPa or mbar Set Weight Unit 1 Select Setup Maintain Enter p...

Страница 86: ...tion Select Setup Maintain Enter system password Configuration to view the configuration information of the ventilator such as ventilation mode Maintenance Information Select Setup Maintain Enter syst...

Страница 87: ...XXXXXXXXXX XXXXXXXXXXXXXXXX XXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXXXXX XXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXXXXXXXX XXXXXXXXXX X...

Страница 88: ...5 14 5 System Settings For your note...

Страница 89: ...e Ventilation NIV 6 9 6 4 3 Set Ventilation Type 6 9 6 5 Ventilation Mode 6 10 6 5 1 Ventilation Mode and Parameters Setup 6 10 6 5 2 Apnea Ventilation 6 12 6 5 3 Sigh Ventilation 6 12 6 5 4 VCV 6 13...

Страница 90: ...6 5 16 PPS 6 25 6 6 Tube Resistance Compensation 6 26 6 7 Leak Compensation 6 27 6 8 Start Ventilation 6 30 6 9 Standby Status 6 30 6 10 Turn the Ventilator Off 6 31...

Страница 91: ...witch on the rear side of machine 3 The alarm indicator light flashes yellow and red once in turn and then the system conducts a self check of the speaker and buzzer once respectively 4 A start up scr...

Страница 92: ...after your confirmation Select the System Check key in the Standby status to enter the System Check screen The system check screen displays the last system check time and total system check result Con...

Страница 93: ...ail indicates that check of this item is completed but is failed Cancel indicates that check of this item is cancelled Select the Detail key to query the system check information of the ventilator sys...

Страница 94: ...the next item If you select Stop the system stops all the items When checks of all items are completed if you select Retry the system starts a new round of check XXXXXXXXXXXXXXXXXX XXXXXXXXXX XXXXXXX...

Страница 95: ...6 5 6 Start Ventilation XXXXXXXXXXXXXXXXXX XXXXXXXXXXX XXXXXXXXXXXXXXXXXX Figure 6 2 Single limb system check prepareation system check items...

Страница 96: ...dal volume high alarm limit tidal volume low alarm limit minute ventilation high alarm limit and minute ventilation low alarm limit The Patient 1 Patient 2 Patient 3 are the user preset for ventilatio...

Страница 97: ...XXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXX XXXX XXXXXXXXXX Figure 6 3 Ventilation settings Select Last Patient from the Standby window The ventilator will start up with the same mode and...

Страница 98: ...VCV Volume Control Ventilation PCV Pressure Control Ventilation VSIMV Volume Synchronized Intermittent Mandatory Ventilation PSIMV Pressure Synchronized Intermittent Mandatory Ventilation PRVC Pressu...

Страница 99: ...roportional Pressure Support S T Spontaneous Timed VS Volume Support CAUTION Do not use NIV on patients with no or irregular spontaneous breaths NIV is intended to provide supplemental ventilatory sup...

Страница 100: ...elease valve so that the airway pressure falls to 3 cmH2O for continuous 0 5s Make sure to set high pressure alarm limit properly to ensure patient safety As false triggering of the ventilator can eas...

Страница 101: ...ion mode area select the required ventilation mode key and the ventilation parameters can be set in this ventilation mode will be displayed in the opened menu 2 Select the key for the ventilation para...

Страница 102: ...on Table 6 1 Apnea settings Parameter Description f apnea Controlled breaths per minute in apnea ventilation Apnea T insp Time of inspiration in apnea ventilation P apnea Pinsp Inspiratory pressure re...

Страница 103: ...s int PEEP PEEP added in sigh cycle 6 5 4 VCV Volume Controlled Ventilation Mode Volume controlled mandatory breaths are administered at a set rate Spontaneous respiratory efforts only trigger control...

Страница 104: ...breaths are administered at a set rate Spontaneous respiratory efforts only trigger controlled breaths in the case of PCV Figure 6 8 PCV waveform Table 6 5 PCV settings Parameter Description O2 Adjus...

Страница 105: ...ment increase of the ventilator cannot exceed 10 cmH2O for the first 3 cycles and cannot exceed 3 cmH2O for each of the following cycles Figure 6 9 PRVC waveform Table 6 6 PRVC settings Parameter Desc...

Страница 106: ...hs are preceded by a trigger window which allows comfortable patient triggered delivery without compromising the set rate Machine triggered mandatory breath Patient triggered mandatory breath Pressure...

Страница 107: ...eaths which are supported by corresponding pressure in set in the rest time of IMV cycle The controlled breaths are preceded by a trigger expectation window which allows comfortable patient triggered...

Страница 108: ...trolled mandatory breaths which are volume targeted PRVC are delivered at the set rate After mandatory breath patient can trigger any number of pressure supported breaths in the rest time of SIMV cycl...

Страница 109: ...ssure Support Ventilation Mode Pressure supported breaths are triggered on a synchronised basis Inspiration ends as soon as the flow has dropped to an adjustable percentage of peak flow Expiration is...

Страница 110: ...reathing is detected in trigger window the transition from P high to P low will be activated if not mechine trigger will activate the trainsition instead BPAP is a highly flexible ventilation mode and...

Страница 111: ...tilation Mode The patient can breathe spontaneously at both pressure levels If a spontaneous breathing is detected in trigger window the transition from P high to P low will be activated if not mechin...

Страница 112: ...time The ramp function is only available for non invasive ventilation of adult and paediatric patients in ventilation modes CPAP S T and PCV with IPAP and EPAP setting 15 15 30 45 60 75 90 P 10 5 0 R...

Страница 113: ...ive ventilation Pressure Patient triggered Spont spontaneous breath with pressure support IPAP lnspiration Time Rise 1 f Mandatory timed breath Time EPAP Figure 6 17 S T waveform Table 6 14 S T settin...

Страница 114: ...PAP 1 f Mandatory timed breath Rise Patient triggered Spont spontaneous breath lnspiration Time Figure 6 18 VS waveform Table 6 15 VS settings Parameter Description O2 Adjustment of oxygen concentrati...

Страница 115: ...compliance 1 f lnspiration Time Figure 6 19 PPS waveform Table 6 16 PPS settings Parameter Description O2 Adjustment of oxygen concentration f Breathing frequency T insp Time of inspiration Rise Rise...

Страница 116: ...ry pressure automatically so that the pressure at the end of the tube is consistent with the ventilator s pressure setting value as much as possible 3 10 1 70 OFF XXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXX...

Страница 117: ...patient s lung is lower than the setting value The leakage also may cause the false inspiratory trigger or difficult switching between inspiratory and expiratory The ventilator provides automatic leak...

Страница 118: ...tion you can set the TV high limit to off Automatic leakage compensation The ventilator determines the difference between the delivered flow on the inspiration side and the measured flow on the expira...

Страница 119: ...L min and is also uncompensated If this were not so the alarm for a low minute volume could be inhibited by the expiratory leakage compensation The ventilator must always emit an alarm if the minute v...

Страница 120: ...Ventilation key in Standby status and the system begins to ventilate the patient according to your settings 6 9 Standby Status Press the Standby key to enter the Standby interface after confirmation...

Страница 121: ...to turn the system off In non standby status if you press the power switch the system will prompt Please enter Standby mode to shut down the system Select OK and the system will remain in non standby...

Страница 122: ...6 32 6 Start Ventilation For your note...

Страница 123: ...g Alarm Numeric 7 6 7 4 5 Alarm Status Symbol 7 6 7 5 Alarm Volume Settings 7 7 7 6 Alarm List 7 8 7 7 Alarm Limits 7 9 7 8 Nurse Call 7 11 7 9 Responding to Alarms 7 13 7 10 Audio Paused 7 14 7 11 AL...

Страница 124: ...2 7 High Pressure 7 18 7 12 8 Low Pressure 7 18 7 12 9 High Tidal Volume 7 18 7 12 10 Low Tidal Volume 7 18 7 12 11 Low Minute Volume 7 19 7 13 Alarm Troubleshooting Table 7 19 7 14 Alarm Parameter 7...

Страница 125: ...lost due to power interruption When the equipment restarts the data are restored automatically When power is lost for less than or equal to 30s the alarm settings prior to the power loss shall be rest...

Страница 126: ...eness is required You can view active or inactive alarms as applicable in the Alarm list window Information about the alarm is also stored in an event log with occurrence time When a low medium or hig...

Страница 127: ...l alarms also called patient status alarms are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition Physiological alarm messages are displayed in th...

Страница 128: ...ess is required 7 4 Alarm Signals When an alarm occurs the ventilator will indicate it to the user through visual or audible alarm signals Alarm Lamp Audible alarm Alarm Messages Flashing numeric Amon...

Страница 129: ...s to match the alarm priority High priority alarms broadcasts the high priority alarm tone Medium priority alarms broadcasts the medium priority alarm tone Low priority alarms broadcasts the low prior...

Страница 130: ...m Numeric If an alarm triggered by an alarm limit violation occurs the numeric of the measured parameter in alarm will flash at a specified frequency NOTE By select the flashing alarm numeric you can...

Страница 131: ...m of a parameter is closed and the alarm signal is in the ALARM OFF mode 7 5 Alarm Volume Settings Set Alarm Volume 1 Select Alarm limit Volume 2 Set Alarm Volume X 10 with X being the minimum alarm v...

Страница 132: ...splayed on the top of screen while the active alarms happen Click the Alarm button to open the Alarm List window which shows the most recent active alarms If no alarms are active the alarm buffer show...

Страница 133: ...can render the alarm system useless To reduce patient risk from inappropriate ventilatory support avoid turning off the alarms CAUTION In the case that high pressure alarm limit of 60 cmH2O is not req...

Страница 134: ...related alarm limits The Alarm Limits window displays the operator adjustable alarm settings XXXXXXXXXX XXXXXXXXXX XXXXXX 50 7 3 2 9 245 980 OFF 15 XXXXXX OFF XXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX...

Страница 135: ...ator is not in AUDIO PAUSED status Follow the steps below to set nurse call 1 Select Setup Maintain Enter user password System Nurse Call 2 Select Switch and toggle between ON and OFF ON to switch on...

Страница 136: ...5 Select Alarm Level and select levels of alarm that will trigger nurse call signal 6 Select Alarm Type and select types of alarm that will trigger nurse call signal If no setting is made for Alarm Le...

Страница 137: ...icators on the front panel of the ventilator A potential hazard can exist if different ALARM PRE SETS are used for the same or similar equipment in any single area To prevent possible patient injury w...

Страница 138: ...he patient if required 2 Determine the alarming parameter or alarm category 3 Identify the alarm source 4 Take proper actions to eliminate the alarm condition 5 Make sure the alarm condition is correc...

Страница 139: ...key again to recover the alarm audio 7 11 ALARM OFF When the alarm limit is set as OFF or alarm is disabled the system will display an ALARM OFF icon showing the parameter alarm limits and correspond...

Страница 140: ...n 3 Set PEEP to 5 cmH2O Verify that the Low PEEP alarm is activated 7 12 2 Patient Circuit Occluded 1 Make sure a demonstration lung is connected to the ventilator and start ventilation in PCV mode no...

Страница 141: ...the Running on Internal Battery alarm is activated and the ventilator is powered by batteries 4 Reconnect the AC power 5 Verify that the alarm resets and the ventilator is again powered by AC 7 12 6...

Страница 142: ...xpiration and airway pressure falls to PEEP level 7 12 8 Low Pressure 1 After the ventilator system starts up normally connect a test lung to the ventilator and start ventilation 2 Set Paw low alarm l...

Страница 143: ...be greater than the current MV 3 Verify that the Low Tidal Volume alarm is activated 7 13 Alarm Troubleshooting Table The below table is a list of the alarm messages displayed by the ventilator along...

Страница 144: ...patient Check the ventilation parameter setup Check the alarm limits Check if the patient tubing are leaked or disconnected 3 High Minute Volume High The measured minute volume is greater the set ala...

Страница 145: ...limit Check the patient Adjust the low frequency alarm limit 9 High Oxygen High The inspired oxygen concentration is greater than the FiO2 high alarm limit for at least 30s Check air supply Check the...

Страница 146: ...Table 7 4 Technical alarm messages Item Alarm Priority Definition Action needed 1 Battery Low Medium The remaining battery power is lower than a threshold Connect to the external power supply 2 Batter...

Страница 147: ...sistance Replace the HEPA filter 8 High Blower Temperature High The blower temperature is too high The ventilation will be stopped Contact service providers 9 High PEEP High Monitored PEEP exceeds PEE...

Страница 148: ...signal from the oxygen cell Install an oxygen cell or use an external monitor 16 Oxygen Supply Failed High O2 pressure is low or highpressure O2 is not connected Check the patient Check connection wit...

Страница 149: ...ervice providers 24 Technical Error 2016 High Battery 1 Aging Contact your service providers 25 Technical Error 2017 High Battery 1 Comm Error Contact your service providers 26 Technical Error 2018 Hi...

Страница 150: ...ontact your service providers 38 Technical Fault 1055 High Pressure release Valve Failure Contact your service providers 39 Technical Fault 1056 High Inspiratory Limb Failure Contact your service prov...

Страница 151: ...ce providers 49 Battery1 recharge failed temperature low Low Battery 1 temp error Unable to charge Connect to the external power supply Wait for the machine to return to normal temperature 50 Battery2...

Страница 152: ...ory valve membrane and cover Check the Flow Sensor tubes for occlusion Adjust breath timing controls to increase the expiratory time 55 Performance limited by high altitude High The altitude is too hi...

Страница 153: ...settings including pressure high alarm limit setting 62 Pressure not reached Low Ppeak fails to reach the set value Check if the tube is leaky If yes re connect Check parameter settings 63 Pressure n...

Страница 154: ...topped Contact service personnel 72 Technical Fault 1074 Medium 3 way valve failure Contact your service personnel 73 Volume Limit Exceeded Low In pressure mode delivered gas exceeds the upper limit o...

Страница 155: ...0 mL Pediatric Off 10 590 mL 5mL VT 0 5 f total High Limit Off 1 90 min 1 min Off f total Low Limit Off 1 89 min 1 min Off T apnea High Limit 5 60 s 1s 15s FiO2 High Limit Low pressure oxygen supply 2...

Страница 156: ...supply 18 98 1 21 Inspiratory Pressure High Limit 2 50 cmH2O 1 cmH2O 50 cmH2O Inspiratory Pressure Low Limit Off 1 48 cmH2O 1 cmH2O off VT High Limit 10 2500 mL 5mL 2500 VT Low Limit Off 5 2490 mL 5m...

Страница 157: ...ions 8 1 8 1 O2 O2 Enrichment 8 1 8 2 Suctioning Tool 8 2 8 3 Manual Breath 8 2 8 4 Inspiratory Hold 8 3 8 5 Expiratory Hold 8 3 8 6 Nebulization 8 4 8 7 P0 1 8 4 8 8 NIF 8 5 8 9 PEEPi 8 5 8 10 PV Too...

Страница 158: ......

Страница 159: ...s increased by 25 of the last oxygen setting The applied oxygen concentration can be set under the Setup Vent O2 during suction window Press the O2 Suction key and the ventilator starts oxygen enrichm...

Страница 160: ...n enrichment If the patient tubes are disconnected the suction procedure starts Disconnecting the patient tubes starts the 2nd stage of suction The system prompts The Patient is Disconnected Reconnect...

Страница 161: ...the Inspiratory Hold key down during the stage of inspiration it performs a hold maneuver at the end of inspiration lasting until the key is released for up to 30s additional 8 5 Expiratory Hold NOTE...

Страница 162: ...ulization is active the nebulizer flow is synchronized with the inspiratory phase of each breath Nebulization can be activated in all modes of ventilation To start nebulization as follows 1 Select the...

Страница 163: ...rement and the result will be displayed after the measurement is completed 8 9 PEEPi The Intrinsic PEEP PEEPi maneuver is used to measure the PEEPi and Vtrap PEEPi is the positive end expiratory press...

Страница 164: ...e optimal PEEP for the patient with the help of this function To perform the PV tool as follow 1 Select the Function PV Tool 2 Setup the below parameters for PV tool P start starting pressure of the s...

Страница 165: ...e inspiratory limb and expiratory limb corresponding to the cursor position and displays the compliance of these limbs 5 Press the History key to select the desired loop in the accessed list The syste...

Страница 166: ...is a way for hypoxia prevention or treatment providing O2 concentration higher than that in the air To start O2 Therapy select the Standby Start O2 Therapy O2 Therapy 490 21 XXXXXXXXXX XXXXXXXXXX XXX...

Страница 167: ...9 3 1 Battery Use Guidance 9 7 9 3 2 Battery Performance Checking 9 7 9 3 3 Battery Performance Conditioning 9 8 9 3 4 Battery Storage 9 9 9 3 5 Battery Recycling 9 10 9 4 Pressure and Flow Zeroing 9...

Страница 168: ......

Страница 169: ...hey are depleted If the running time of the battery is noticeably shorter than that stated in the specifications replace the battery or contact the servive providers NOTE It is the user s responsibili...

Страница 170: ...nce in the repair of devices of this nature After repair test the ventilator to ensure that it is functioning properly in accordance with the specifications NOTE No repair should ever be attempted by...

Страница 171: ...ventilator according to the schedule in Table 9 1 The following subsections provide details for some of these preventive maintenance procedures Table 9 1 Schedule of preventive maintenance Interval P...

Страница 172: ...for damage Replace as necessary Ventilator Clean the external surfaces O2 sensor Please calibrate the O2 sensor Replace CO2 sensor if it is damaged Every month or as necessary Air intake dust filters...

Страница 173: ...hortens cell life Air intake HEPA filter Replace Check the HEPA filter for occlusion replace it when necessary Ventilator Perform service related preventive maintenance Gas source sealing ring Check t...

Страница 174: ...recharged every 6 months depending on storage conditions Please set the battery to ship mode if the ventilator is not likely to be used for some time The battery provides 12 months shelf life with in...

Страница 175: ...or a properly maintained and stored lithium battery its life expectancy is approximately 2 years For more aggressive use models life expectancy can be shortened We recommend replacing lithium batterie...

Страница 176: ...urs 3 Disconnect the external power source Allow the ventilator to operate on battery power until the ventilator shuts off 4 The running time of the battery reflects its performance If the running tim...

Страница 177: ...nnect the ventilator to the external power source and charge the batteries uninterruptedly for at least 10 hours 9 3 4 Battery Storage If the ventilator is not used for a long time contact servive pro...

Страница 178: ...flow value has a great deviation Zeroing can be performed in standby mode only Follow these steps to zero pressure and flow 1 Open the Setup Sensor Zeroing Paw Flow window to access the pressure and...

Страница 179: ...se calibrate the flow sensor when the measured value has a great deviation or when the flow sensor is replaced Follow the steps below to calibrate flow 1 Connect the breathing tubes and insert the pat...

Страница 180: ...XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX Figure 9 2 Flow calibration 9 6 Oxygen Concentration Calibration NOTE Make sure another s...

Страница 181: ...cell in use Please calibrate the oxygen concentration when the measured oxygen concentration has a great deviation or when the O2 sensor is replaced Follow these steps to calibrate the oxygen concent...

Страница 182: ...XXXX Figure 9 3 O2 calibration 9 7 Electrical Safety Inspection NOTE Perform an electrical safety inspection after servicing or routine maintenance Before performing the electrical safety inspection e...

Страница 183: ...y with open neutral reverse polarity with open neutral Verify that the maximum leakage current does not exceed 500 A 0 5 mA in the first two tests In the final two tests verify that the maximum leakag...

Страница 184: ...igher than 500 uA 0 5 mA on the BF type applied parts that the maximum leakage current in the last two tests is not higher than 50 A 0 05 mA on the CF type applied parts and not higher than 5000 uA 5...

Страница 185: ...t Disassemble 10 6 10 2 1 Expiration Valve Assembly and Membrane 10 6 10 2 2 Inspiratory Valve Assembly 10 7 10 2 3 HEPA Filter and Air Intake Dust Filter 10 8 10 2 4 Cooling Fan Dust Filter 10 9 10 2...

Страница 186: ......

Страница 187: ...uid flows into the control assemblies and always disconnect the equipment from the AC mains Reconnect the AC mains after the cleaned parts are fully dry To avoid sticky residuals do not use talc zinc...

Страница 188: ...d disinfected Different parts of the ventilator should be disinfected using different methods You need to select the appropriate method to clean and disinfect the parts based on the actual situations...

Страница 189: ...minutes recommended time Ultraviolet radiation for 30 to 60 minutes recommended time The table below lists the cleaning and disinfecting method can be selected for ventilator part Table 10 1 The meth...

Страница 190: ...then wipe off the remaining detergent with a dry lint free cloth Immersion flush with water first and then immerse it in alkalescent detergent soapy water etc water temperature of 40 C recommended for...

Страница 191: ...ethods and do not require that all methods be used The table below lists the cleaning and disinfecting agents and autoclaving process that may be used on the ventilator Table 10 2 Cleaning and disinfe...

Страница 192: ...isassemble 1 Rotate the expiration valve handwheel until the indicating arrow on the handwheel is aligned with the unlock position Then pull the expiration valve assembly out of the assembly horizonta...

Страница 193: ...cating arrow on the handwheel is aligned with the lock position 10 2 2 Inspiratory Valve Assembly 1 Silicone plug 2 inspiratory valve 3 Sealing ring Figure 10 2 Disassemble inspiration valve To disass...

Страница 194: ...ration valve is fully locked by the button 10 2 3 HEPA Filter and Air Intake Dust Filter 1 2 3 1 HEPA filter 2 Air intake dust filter 3 Cover Figure 10 3 Disassemble filters To disassemble 1 Open the...

Страница 195: ...Fasten the HEPA filter latch 2 Check whether the key placement above HEPA has been installed correctly 3 Close the cover NOTE Install the specified HEPA filter and air intake dust filter 10 2 4 Cooli...

Страница 196: ...cooling fan 2 Close the cover 10 2 5 Patient Tubing WARNING To minimize the risk of bacterial contamination or physical damage remove and install the bacterial filter with care CAUTION When removing...

Страница 197: ...ratory water trap 5 Expiratory water trap 6 Support arm hook Figure 10 5 Disassemble patient tube 10 2 6 Humidifier NOTE The humidifier shall comply with the requirements of ISO 8185 The humidifier as...

Страница 198: ...er To disassemble 1 Disconnect the tubes from the humidifier 2 Remove the screw 3 Lift up the humidifier to remove it from the humidifier bracket fixed seat To install Refer to 3 3 Installing the humi...

Страница 199: ...Nebulizer 3 Nebulizer tube Figure 10 7 Disassemble nebulizer To disassemble 1 Pull out the nebulizer tube from the nebulizer connector 2 Pull out the nebulizer tube from the nebulizer and remove the n...

Страница 200: ...10 14 10 Cleaning and Disinfection For your note...

Страница 201: ...al Requirements 11 2 11 3 Electrical Specifications 11 4 11 4 Pneumatic Specifications 11 5 11 5 Control Settings 11 6 11 6 Monitored Parameters 11 10 11 7 Configuration Specifications 11 15 11 8 Fact...

Страница 202: ......

Страница 203: ...11 1 11 Specifications 11 Specifications 11 1 Physical Characteristic...

Страница 204: ...Table 11 2 Environment requirement Parameter Specification Temperature Operating 5 to 40 41 to 104 F Storage 20 to 60 4 to 140 F Relative humidity Operating 10 to 95 RH non condensing Storage 10 to 95...

Страница 205: ...m Temperature Relative humidity non condensing Barometric pressure Operating 0 to 50 0 to 99 RH 0 6 to 2 bar Storage 20 to 50 Recommend 5 to 15 0 to 99 RH 0 6 to 2 bar The environment required for bat...

Страница 206: ...d equipment Type BF applied part IP21 Not Sterilized Not Category AP APG equipment Mode of operation Continuous Batteries Number One or Two Optional Type Lithium ion Voltage 14 4 V Volume 6900 mAh for...

Страница 207: ...l 15 mm 22 mm conical connector Inspiratory resistance Not greater than 6 cm H2O at 40 L min flow adult reusable breathing tube Not greater than 6 cmH2O at 30 L min flow pediatric reusable breathing t...

Страница 208: ...2 mL cmH2O Pediatric reusable circuit including inspiratory valve pediatric reusable breathing tubes water trap expiration valve Ypiece 2 mL cmH2O 11 5 Control Settings Timing trigger pressure trigger...

Страница 209: ...cmH2O P insp 5 to 80 cmH2O 1 cmH2O 2 0 cmH2O 5 Relation expanded uncertainty k 2 U 1 2 cmH2O P supp 0 to 80 cmH2O 1 cmH2O 2 0 cmH2O 5 P high 0 to 80 cmH2O 1 cmH2O 2 0 cmH2O 5 P low 0 to 45 cmH2O 1 cm...

Страница 210: ...5 of set value Sigh Interval 20 s to 180 min 1 s 20 to 59 s 1 min 1 min to 180 min 0 2 s or 10 of set value whichever is greater Sigh Cycle 1 to 20 1 1 T pause off 5 to 60 0 01 0 1s or 10 of set valu...

Страница 211: ...f set value Ramp off 5 to 45 min 5 min 5s P max 6 to 40 cmH2O 1 cmH2O 2 0 cmH2O 5 of set value P min 5 to 30 cmH2O 1 cmH2O 2 0 cmH2O 5 of set value P max 5 to 40 cmH2O 1 cmH2O 2 0 cmH2O 5 of set value...

Страница 212: ...that are displayed or used for control the low pass filtering and moving average smoothing techniques is used Table 11 7 Dual limb monitored parameters Parameter Range Resolution Accuracy Paw 0 100 cm...

Страница 213: ...3 L min whichever is greater VTe 0 20 mL 10 1cmH2O 10 0 1 cmH2O 2 mL 3 of the actual reading 20 100 mL 10 mL 3 of the actual reading 100 4000 mL 3 mL 10 of the actual reading VTi 0 20 mL 10 1cmH2O 10...

Страница 214: ...10 1 99 1 0 1 or 10 of actual reading whichever is greater FiO2 15 to 100 vol 1 vol 2 5vol 2 5 of actual reading Re 0 600 cmH2O L s 1 cmH2O L s 0 50cmH2O L s 10cmH2O L s Other range 50 of the actual r...

Страница 215: ...L min or 8 of actual reading whichever is greater O2 15 to 100 vol 1vol 2 5vol 2 5 of actual reading PEEPi 0 to 100 cmH2O 0 1 cmH2O MVtalv 0 to 20 L min 1 L min 0 01 L min 1L min 0 1L min slopeCO2 0 t...

Страница 216: ...ding MV 0 to 99 9 L min 0 1 L min 0 3 L min or 8 of actual reading whichever is greater VT 0 to 3500mL 1mL 4mL 10 of actual reading f 0 to 99 1 1 min or 5 of actual reading whichever is greater I E 9...

Страница 217: ...tional Pressure Support S T Spontaneous Timed VS Volume Support VCV Volume Control Ventilation VSIMV Volume Synchronized Intermittent Mandatory Ventilation PSIMV Pressure Synchronized Intermittent Man...

Страница 218: ...on STRC Synchronized Tube Resistance Compensation O2 Enrichment Suction Tool Nebulization Manual breath Inspiratory Hold Expiratory Hold PV Tool P0 1 Airway Occlusion Pressure NIF Negative Inspiratory...

Страница 219: ...11 8 Factory Default Settings Table 11 12 Ventilation mode settings Mode Parameter Factory Default Settings VCV VT Adult max 7 mL kg IBW 100 Pediatric 7 mL kg IBW O2 HPO 21 f Adult 10 min Pediatric 2...

Страница 220: ...E 1 2 T slope 0 2 s F trigger Adult 2 0 L min Pediatric 1 0 L min Assist ON Sigh OFF Sigh Interval 1 min Sigh Cycles 3 int PEEP 5 cmH2O CPAP PSV O2 HPO 21 PEEP 3 cmH2O P supp 0 cmH2O T slope 0 2 s F t...

Страница 221: ...ric 1 0 L min Exp Auto P apnea 15 cmH2O f apnea 1 min Apnea T insp Adult 2 00 s Pediatric 1 00 s VT apnea Adult max 7 mL kg IBW 100 Pediatric 7 mL kg IBW Apnea Vent ON Sigh OFF Sigh Interval 1 min Sig...

Страница 222: ...lt max 7 mL kg IBW 100 Pediatric 7 mL kg IBW Apnea Vent ON Sigh OFF Sigh Interval 1 min Sigh Cycles 3 int PEEP 5 cmH2O T pause OFF V SIMV VT Adult max 7 mL kg IBW 100 Pediatric 7 mL kg IBW O2 HPO 21 f...

Страница 223: ...n Sigh Cycles 3 int PEEP 5 cmH2O BPAP O2 HPO 21 P supp 0 cmH2O T slope 0 2 s P high 15 cmH2O P low 3 cmH2O T high Adult 1 7 s Pediatric 0 7 s T low Adult 3 3 s Pediatric 1 4 s F trigger Adult 2 0 L mi...

Страница 224: ...iatric 1 00 s I E 1 2 T slope 0 2 s F trigger Adult 2 0 L min Pediatric 1 0 L min Assist ON Sigh OFF Sigh Interval 1 min Sigh Cycles 3 int PEEP 5cmH2O APRV O2 HPO 21 T slope 0 2 s P high 15 cmH2O P lo...

Страница 225: ...mp OFF P apnea 5 cmH2O f apnea 1 min Apnea T insp Adult 2 00 s Pediatric 1 00 s S T O2 HPO 21 f Adult 10 min Pediatric 20 min T insp Adult 2 00 s Pediatric 1 00 s I trigger 3 E cycle 3 IPAP 5 cmH2O EP...

Страница 226: ...igger 3 E cycle 3 EPAP 10 cmH2O Rise 3 P min 10 cmH2O P max 20 cmH2O PPS O2 HPO 21 f Adult 10 min Pediatric 20 min T insp Adult 2 00 s Pediatric 1 00 s I trigger 3 E cycle 3 IPAP 5 cmH2O EPAP 10 cmH2O...

Страница 227: ...nitoring ON System Date 2017 01 01 System Time 00 00 00 Date Format YYYY MM DD Time Format 24h Paw Unit cmH2O Weight Unit kg O2 Supply HPO STRC Tube Compensation Disable Tube I D 8 0mm Adult 5 0mm Ped...

Страница 228: ...there is a case of a higher voltage battery charging a lower voltage battery How to consider the design Two batteries is connected by the diode The high voltage diode will be switched on while the low...

Страница 229: ...g equipment failure 6 0 cmH2O at 2 5 L min using a 10 mm circuit 6 0 cmH2O at 15 L min using a 15 mm circuit 6 0 cmH2O at 30 L min using a 22 mm circuit Audio alarm loudness 45 to 85 dB A primary alar...

Страница 230: ...11 28 11 Specifications For your note...

Страница 231: ...Appendix A Pneumatic Diagram A 1 B Parts and Accessories B 1 C Communications Interface C 1 D EMC Declarations D 1 E Compliance E 1 F Neonatal Ventilation F 1 Glossary 1...

Страница 232: ......

Страница 233: ...A 1 A Pneumatic Diagram A Pneumatic Diagram Figure A 1 Pneumatic diagram...

Страница 234: ...ensor R2 Rinse resistor CV1 Self closing cut off valve SOL1 Zeroing three way valve REG Regulator SOL2 zeroing three way valve PSOL Proportional valve SOL3 zeroing three way valve F4 Filter net Insp P...

Страница 235: ...to prevent any adverse reactions arising from such contact The duration of contact category should be less than 24 hours Disposal of the accessories shall comply with the applicable waste control reg...

Страница 236: ...VH 1500RX 220V 50104 000005 00 VADI 10 Face mask size small 5000 000021 00 BMC 11 Face mask size medium 5000 000014 00 BMC 12 Face mask size large 5000 000022 00 BMC 13 Test lung 50105 000004 00 VADI...

Страница 237: ...VADI 31 Disposable adult dual limb breathing circuit heating EN 50101 000021 00 VADI 32 Disposable neonatal dual limb breathing circuit heating EN 50101 000022 00 VADI 33 Reusable adult dual limb brea...

Страница 238: ...turer 41 Support arm 10199 000001 00 RESVETN 42 Inspiratory valve assembly reusable 60201 000009 00 Resvent 43 Expiratory valve assembly reusable 60201 000007 00 Resvent 44 Air inet dust filter 10006...

Страница 239: ...data export NEVER connect or attempt to power any other equipment from the USB port It is the responsibility of the end user to validate the compatibility and use of information transmitted from the...

Страница 240: ...C 2 C Communications Interface For your note...

Страница 241: ...figuration in which it will be used The ventilator needs special precautions regarding EMC and needs to be mounted and put into service according to the EMC information provided below Other devices ma...

Страница 242: ...s for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies TableD 2 Guidance and manufacturer s declaration electromagnetic immunity...

Страница 243: ...es 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power qua...

Страница 244: ...ble and mobile RF communications equipment should be used no closer to any part of the ventilator including cables than the recommended separation distance calculated from the equation appropriate for...

Страница 245: ...f it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transm...

Страница 246: ...the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher f...

Страница 247: ...EC 60601 1 2 EN 60601 1 2 Electromagnetic compatibility IEC 60601 1 6 EN 60601 1 6 Usability IEC 62366 1 EN 62366 1 Usability IEC 60601 1 8 EN 60601 1 8 Alarm systems ISO 80601 2 55 EN ISO 80601 2 55...

Страница 248: ...E 2 E Compliance For your note...

Страница 249: ...ase check the patient circuit and the neonatal flow sensor for leak and or occlusion Replace the neonatal flow sensor if necessary After conducting the system check DO NOT add or remove any accessorie...

Страница 250: ...k the sensor and the tubing periodically to avoid excessive moisture and or accumulation of secretions The neonatal flow sensor is disposable and may not be used repeatedly Attempts to clean or disinf...

Страница 251: ...ation valve assembly out of the assembly horizontally 2 Remove the expiration valve membrane To install 1 Install the expiration valve membrane onto the neonatal expiration valve assembly 2 Ensure tha...

Страница 252: ...the water trap via the neonatal tubing Then connect the water trap to the Y piece via the neonatal tubing 4 Connect the expiratory filter to the water trap via the neonatal tubing Then connect the wat...

Страница 253: ...4 Ventilation Type 3 For ventilation mode setup please see 6 5 Ventilation Mode 4 For alarm setup please see 7 Alarms 5 Select the Start Ventilation key in Standby status and the system begins to ven...

Страница 254: ...as a great deviation Refer to 9 5 Flow sensor calibration NOTE Please pay attention to the connection direction of the sensor during calibration First the forward ventilation then the reverse ventilat...

Страница 255: ...O 2 0 cmH2O 5 of setting P insp 3 to 60 cmH2O 1 cmH2O 2 0 cmH2O 5 of setting P supp 0 to 45 cmH2O 1 cmH2O 2 0 cmH2O 5 of setting P high 0 to 45 cmH2O 1 cmH2O 2 0 cmH2O 5 of setting P low 0 to 25 cmH2O...

Страница 256: ...ass filtering and moving average smoothing techniques is used NOTE The unlisted parameters are the same as the corresponding parameters of adult Table F 2 Monitored parameters Parameter Range Resoluti...

Страница 257: ...E max Maximum elastance volume assist EPAP Expiratory positive airway pressure ET Endotracheal EtCO2 End tidal Carbon Dioxide Exp Inspiratory termination level The ventilator is switched to the expir...

Страница 258: ...tion O2 Oxygen concentration the volume percentage of oxygen in the mixed gas delivered to the patient P0 1 100ms Occlusion Pressure Paw Airway Pressure PCV Pressure Control Ventilation PEEP Positive...

Страница 259: ...nspiratory limb to the expiratory limb Ramp Can be used to allow the patient to become accustomed to respiratory ventilatory therapy over time Ramp will allow the pressure to linearly increase over a...

Страница 260: ...ope in pressure mode V alv alveolar minute ventilation V CO2 CO2 elimination VDaw Airway dead space VDaw VTe Ratio of airway dead space to tidal volume VeCO2 Exhaled CO2 volume ViCO2 Inspired CO2 volu...

Страница 261: ...essure It is a relative value relative to PEEP P insp It is a relative value relative to PEEP P supp Pressure Support Level It is a relative value relative to PEEP or P low P apnea Pressure of Apnea V...

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