Resvent iHope RS Series User Manual Download Page 241

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D-1

D. EMC Declarations

D. EMC Declarations

NOTE

•

Using accessories other than those specified may

result in increased electromagnetic emission

or decreased electromagnetic immunity of the

equipment.

•

The ventilator or its components should not be

used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, the ventilator

or its components should be observed to verify

normal operation in the configuration in which it

will be 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 may interfere with this equipment

even though they meet the requirements of CISPR.

•

When the input signal is below the minimum

amplitude provided in technical specifications,

erroneous measurements could result.

•

Use of portable or mobile communications devices

can degrade the performance of the equipment.

The ventilator is in compliance with IEC 60601-1-2 for

EMC.
The essential performance verified during the immunity

testing.

Summary of Contents for iHope RS Series

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 10: ......

Page 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...

Page 12: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 28: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 38: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 74: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 186: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 202: ......

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 232: ......

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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