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Operational verification |

iTernIS ADV

15.

Operational verification

CHAPTER CONTENTS

15.1

Necessary items

15.2

Ventilator preparation

15.3

Functional verification

15.4

Alarms Verification

15.5

Operative Verification

CHAPTER SUMMARY

This chapter lists a series of tests to be performed on the ventilator in order to de-
termine whether it is in good operating condition.

Summary of Contents for iTernIS ADV

Page 1: ...Operator s Manual Rev 1 0 07 2011 INNOVATIONS AS A SERVICE TO THE PATIENT ...

Page 2: ......

Page 3: ...User s Instruction Manual Rev 1 0 07 2011 ...

Page 4: ...document before connecting the ventilator to a patient The information included in this manual is aimed at des cribing the ventilator what it can do and its possible settings but it cannot nor should not be considered as a substitute for the required judgment by competent professionals who should decide and determine the mode of use for each patient in particular HEYER Medical AG Carl Heyer Str 1 ...

Page 5: ...Connection to the Power Source 3 6 3 6 Patient Circuit 3 7 3 7 O2 Sensor 3 12 4 General Description Sections of the Ventilator 4 1 4 1 General Description 4 3 4 2 Front Panel 4 3 4 3 Lower Block of Connections 4 11 4 4 Rear Panel 4 12 4 5 Upper Panel 4 12 5 Start up and Initial Calibration 5 1 5 1 Start Up 5 3 5 2 STAGE 1 Initial Automatic Control 5 3 5 3 STAGE 2 Patient Category Selection 5 3 5 4...

Page 6: ...vasive Ventilation 9 16 9 11 PRVC Pressure Regulated Volume Controlled Ventilation 9 17 9 12 Backup Ventilation 9 19 10 NEO INF Operative Modes 10 1 10 1 VCV Volume Controlled Ventilation 10 3 10 2 PCV Pressure Controlled Ventilation 10 4 10 3 PSV CPAP Pressure Supported Ventilation CPAP 10 5 10 4 SIMV VCV PSV Synchronized Intermittent Mandatory Ventilation 10 6 10 5 SIMV PCV PSV Synchronized Inte...

Page 7: ...ication 15 4 15 5 Operative Verification 15 5 16 Cleaning and Maintenance 16 1 16 1 Cleaning and Sterilization 16 3 16 2 Assembly of the Patient Circuit 16 5 16 3 Maintenance 16 6 16 4 Periodical Safety Related Controls 16 8 17 Technical Specifications 17 1 17 1 Classification 17 3 17 2 Physical Characteristics 17 3 17 3 Screen 17 3 17 4 Environmental Requirements 17 3 17 5 Pneumatic Specification...

Page 8: ... Maintained Visual Light Signal Alarm Signals 11 5 Table 11 5 Auditory Signal Non Maintained 11 6 Table 11 6 Inop Vent Alarm signals 11 9 Table 11 7 High Priority Alarms 11 9 Table 11 8 Medium Priority Alarms 11 10 Table 11 9 Low Priority Alarms 11 11 Table 15 1 Functional Verification 15 4 Table 15 2 Alarm Verification 15 5 Table 16 1 Suggested Preventive Maintenance 16 6 Table 17 1 Ventilator Cl...

Page 9: ...iTernIS ADV v Table 17 14 Recommended Separation Distances between the Ventilator and Mobile Portable Communications Equipment 17 10 Table 17 15 Ventilation Parameters in Emergency Ventilation 17 12 Table 17 16 Lifetime 17 14 ...

Page 10: ...User Instruction Manual iTernIS ADV vi This Page Left Intentionally Blank ...

Page 11: ... for use 1 7 User support 1 8 Symbols used 1 9 Abbreviations acronyms and variable names Introduction 1 CHAPTER SUMMARY This introductory chapter details the concepts defining iTernIS ADV These defini tions provide information about the equipment and its appropriate use The infor mation included in this chapter is to be used as mandatory guidelines for the design and development of iTernIS ADV ...

Page 12: ...Introduction iTernIS ADV 1 2 This Page Left Intentionally Blank ...

Page 13: ...c requirements for flat panel displays iTernIS ADV is a microprocessor controlled mechanical ventilator which incorpo rates the most advanced methods for ventilatory support The electronic circuit operates two proportional valves which provide the gas flow necessary to satisfy the selected configuration The iTernIS ADV ventilator was designed to be used with all types of patients adult pediatric a...

Page 14: ...ring the inter hospital transfer of patients mobilization outside the assigned institution Failure to strictly comply with the instructions for use user and intended use en vironment for this ventilator If you need technical support please send an email to service heyermedical de Please be sure to include the name of the institution to which the equipment belongs and the contact details where a re...

Page 15: ...Alarm off Icon indicating that an alarm has been deactivated Alarm limits Exhaled gas discharge port from patient Connection for the expiration set Inhaled gas delivery port to patient Connection port for the nebulizer P1 P2 Connection ports for the distal pneumota chograph hoses Prox Connection port for the proximal pneumo tachograph O2 Connection port for the O2 cell Authorized representative in...

Page 16: ...oscale On screen display for screenshot in pro gress On screen display for nebulization on On screen display for Ctrl key pressed On screen display for passive humidifier selected On screen display for active humidifier se lected Screen lock Proximal pneumotachograph activated On screen display for maintenance requi red O2 Concentration of O2 ADL Adult APRV Airway pressure release ventilation Cdin...

Page 17: ...iratory rate I E Inspiratory time expiratory time ratio Insp Inspiration or inspired Lip Upper inflection point MMV Mandatory minute ventilation NEO INF Neonate Infant O2 100 100 oxygenation P V flex Inflection points P0 1 Pressure during the first 100 ms P1 Lower hose inlet of expiratory pneu motachograph P2 Upper hose inlet of expiratory pneu motachograph Paw Airway pressure PCV Pressure control...

Page 18: ...ion TCPL Time cycled pressure limited ventila tion Te Expiratory time Ti Inspiratory time Uip Upper inflection point V Flow VCO2 Eliminated CO2 VCV Volume control ventilation VE Expired minute volume VE Espont Spontaneous expiratory minute volu me VE Mandat Mandatory expired minute volume VM Minute volume Vmax Maximum volume NIV Noninvasive ventilation VT or VT Tidal volume WOBi Imposed work of br...

Page 19: ...nings 2 3 Precautions 2 4 Notes 2 CHAPTER SUMMARY Warnings precautions and notes are used to highlight relevant information that the reader must know This chapter defines the meaning of the terms warning caution and note in the context of this manual and summarizes some of the most important definitions of each of them ...

Page 20: ...Warnings Precautions Notes iTernIS ADV 2 2 This Page Left Intentionally Blank ...

Page 21: ...tient frequently and properly It is also mandatory to be prepared to provide an alternative way of ventilation iTernIS ADV is not intended to function as a support for anes thetic machines The use of the ventilator in anesthesia admi nistration procedures is not considered as an intended use indication Do not use the ventilator in the presence of flammable anes thetic gases This can cause an accid...

Page 22: ... the inner middle a membrane whose integrity is essential for the proper reading of the expired volume When cleaning this part you must be careful not to damage the membrane While the ventilator is ventilating a patient do not establish any connection between it and a data network or to any ex ternal equipment that does not meet electrical safety require ments necessary to be considered as an elec...

Page 23: ... values and is stored in temporary memory while the computer stays on It is not possible to start the calibration of the ventilator using only compressed AIR While a ventilator parameter value is being changed and is still not accepted the previous value remains active Similarly if the change is not accepted within a maximum time of 15 seconds the previous value is not modified Maintenance Notice ...

Page 24: ...Warnings Precautions Notes iTernIS ADV 2 6 This Page Left Intentionally Blank ...

Page 25: ...of the Pedestal 3 3 Attachment of Ventilator to the Pedestal 3 4 Connection to the Gas Source 3 5 Connection to the Power Source 3 6 Patient Circuit 3 7 O2 Sensor 3 CHAPTER SUMMARY This chapter contains the information needed to assemble the ventilator mount it on the pedestal connect it to power sources and prepare it to be put into use ...

Page 26: ...Assembly and installation iTernIS ADV 3 2 This Page Left Intentionally Blank ...

Page 27: ...pressed air supply hose with connection ends 1 O2 supply hose for intra hospital transfer from 2 O2 tubes 1 Compressed air filter 2 Expiratory sets expiratory valve expiratory pneumatograph and connecting hoses 1 Reusable patient circuit for ADL PED or NEO INF class with connectors 1 O2 Sensor 1 Test lung 1 Nebulizer with connectors 1 Power cord for 110 220 V 1 Heater Humidifier with connecting el...

Page 28: ...column and the wheels with brakes on the base are facing to the same side front of the pedestal Fig 3 2 Pedestal Assembly Images Left vertical column mounting on the base Right plate locking screw tightening Place the plate on top of the vertical column aligning the plate bolt with the ope ning in the column Insert and tighten the locking screw with the 5 mm hex key Attach the lateral bars to the ...

Page 29: ...source or compressor Tighten by hand the female connector of the oxygen pressure tube to the ven tilator OXYGEN inlet Place the free end of the oxygen pressure tube into the compressed oxygen source intake Fig 3 5 Connection of gases from the source A compres sed air filter inserted at the AIR inlet is shown WARNING ALWAYS use a water filter for compressed air at the equipment AIR intake The use o...

Page 30: ...back panel of the equip ment Connect the provided power cable to the equipment 110 220 V power intake socket switching from one voltage to another is automatic Attach the safety clasp to the cord to avoid accidental disconnections Use a 2 5 mm hex key to do this Fig 3 6 Plug the other end of the power cord into an appropriate three pin power intake Do not remove the third pin of the power cord plu...

Page 31: ...ge alarm signals appear when the equipment is turned on the ventilator should be connected for at least eight 8 hours If these signals persist it may be an indication that the battery needs replacing In this case consult with an authorized service provider NOTE When the ventilator is powered by the internal battery it has the same operational capacities as when plugged into the power network using...

Page 32: ...the Y piece to the ventilator are Segment of hose up to the water trap Water trap Section of hose up to the expiratory set Expiratory Set The Y piece is a single unit that links the inspiratory and expiratory segments of the pa tient circuit and provides the connection to the patient The tracheal tube intermediary is connected to the 15 mm female opening of the piece A capnograph or a proximal pne...

Page 33: ...ion as placed on the body of the set with the diaphragm in the correct position To disassemble the set Grasp the cap and turn counterclockwise until it can be removed Once the cap is removed the diaphragm is freed To assemble the set Place the diaphragm in the expiratory set cap as shown in Fig 3 7 It can also be done on the upper part of the set body carefully keeping the ring shaped piece pointi...

Page 34: ...or can receive the free end of the last segment of the expiratory segment WARNING The pneumotachograph incorporated into the expiratory set has a delicate transparent membrane inside it This must not be dama ged in order for the expiratory flow and vo lume measurements to be correct When replacing always use original dia phragms Similar non original diaphragms may cause malfunctioning of the valve...

Page 35: ... sensor during nebulization Place the pneumotachograph on the Y piece so that the hoses stay upward as the mark on the pneumotachograph body indicates This is useful to avoid that condensed water pene trates into the hoses and obstructs the airway The sensor hoses should not be obstructed Periodically verify that the hoses are not kinked or caught Do not use force on the sensor hoses Do not pull t...

Page 36: ...y be removed to reveal the sensor by turning the cap counterclockwise The plastic body of the sensor or O2 cell has a threaded segment in its upper part that keeps it in a fixed position To remove the sensor the connector Jack plug must first be removed and then the body of the sensor turned until it is freed Fig 3 10 Picture of the lower block of connections showing the oxygen sensor A sensor cap...

Page 37: ... 1 Overview 4 2 Front Panel 4 3 Lower block of connections 4 4 Rear Panel 4 5 Upper Panel 4 CHAPTER SUMMARY This is a descriptive chapter which individualizes the ventilator parts and highlights in detail each of their functions The equipment is divided into three sections grou ping the descriptions of related attributes ...

Page 38: ...General description Sections of the ventilator iTernIS ADV 4 2 This Page Left Intentionally Blank ...

Page 39: ... the management of all functions All connection points of the ventilator whether they are electric or pneumatic res pect the relevant standards For the purpose of its description the ventilator is divided into four sections Front panel Lower block of connections Rear panel Upper panel Fig 4 1 Picture of iTernIS ADV front panel References of the Fig 4 1 Screen Alarm Signals Light Indications of the...

Page 40: ...r As one or other operative mode is selected the amount and nature of these parameters may vary Fig 4 2 Picture of a screenshot in which the field reserved for the controller settings is highlighted operative mode screen SIMV VCV PSV The upper area of the screen houses the parameter values monitored by the ven tilator On the left of this area a label indicates the patient category the operative mo...

Page 41: ... Inspiratory time s It is indicated for each breath in all modes The pause time is added when programmed or when run manually Te Expiratory time s Resulting expiratory time upgraded with each new breath Current I E I E It indicates the inspiration expiration resulting ratio fTOTAL Total rate rpm Total rate spontaneous and mandatory breaths expressed in breaths per minute VT Expirated tidal volume ...

Page 42: ...chanics Save loop Nebulizer Help help on the meaning of touch and fixed keys Stand by On the left hand area of the screen there are two touch buttons for rapid access to modifying the limits of inspiratory pressure alarms Maximum inspiratory pressure Minimum inspiratory pressure Fig 4 4 The right hand toolbar which identifies touch com mands for certain functions and the left hand toolbar which am...

Page 43: ...ient Peak pressure Peak It indicates the peak pressure maximum achieved in each breath Tracheal pressure Trach It indicates the estimated tracheal pressure when the function Tube Compensation is activated Plateau pressure Plateau It indicates the pressure maintained during inspiration when inspiratory pause has been scheduled or when pressing Insp Exp Pause Mean pressure Mean It indicates the mean...

Page 44: ... a sequence of three statuses of the Toolbar icons and messages have been copied when there are 4 active messages Fig 4 5 The three toolbars indicate the sequence of messa ges when functions are found to be active Volume compen sation Leakage compensation Sigh and Inspiratory pause The right hand area is dedicated to a space for the emergence of On screen noti ces of the alarm system Whenever an a...

Page 45: ...e preset values but can be reprogrammed By pressing the key a menu appears with the alarms modifiable by the user Paused audio Pressing the key once will pause the alarm beep during 30 s pres sing the key twice will result in a pause of 60 s Selection of operative modes Pressing this key leads to the menu OPERATIVE MODES from which you can select one of the enabled operative modes for the current ...

Page 46: ...ge of the value in steps of ten units Ctrl Ctrl Reset all sensors to zero Ctrl Manual Insp Sigh if programmed Ctrl Graphic 1 Refreshes screen 2 Deletes the reference loop on the screen but remains in memory Esc It is a key with multiple primary functions or in combination with other keys This key among other functions allows for Restoring the light signal of any activated alarm Cancelling or abort...

Page 47: ...ic power source light indicators Indicator On Off Color Status 110 220 VAC Battery Charge On green Off Ventilator powered by 110 220 VAC mains 110 220 VAC Battery Charge Off On Blue Ventilator powered by its internal battery 110 220 VAC Battery Charge On green On green Ventilator powered by 110 220 VAC mains Battery charging time In the chapter Assembly and Installation the types of connections ar...

Page 48: ...mbly and Installation there is a description on how to execute the connections Fig 4 10 Picture of the rear panel of the ventilator References of the Fig 4 10 Blower air outlet Audio output for the alarm audio RS 232 port Electric switch Input AC filter for the electric power source with fuse box Air inlet Oxygen inlet On the upper part of the ventilator cabinet there is the upper light indicator ...

Page 49: ...5 Start patient circuit calibration 5 7 STAGE 6 Calibration in process 5 CHAPTER SUMMARY The ventilator can be used right after it has been properly assembled and installed in the place of intended use This chapter describes the initial procedure from start up up to the time of configuration of the operative mode that the ventilator will use to operate This document contains the information needed...

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Page 51: ...touch screen buttons to select the chosen category NOTE Changing category of the patient is performed only at this stage To change the category of patient while operating the equipment first be sure to turn off the ventilator and complete again the stages outlined in this chapter By choosing a patient category the menu is displayed on the screen IBW BASED VT where you can set two variables With th...

Page 52: ... will be shown NOTE The IBW and mL kg configuration only affects the determination of the initial VT The rest of the ventilatory parameters keep the preset va lues Fig 5 1 Menu display IBW BASED VT Table 5 2 Ideal Body Weight Women IBW kg 45 5 0 91 x height en cm 152 4 1 Height IBW kg 4 6 mL kg VT Range 6 8 mL kg VT Range 8 10 mL kg VT Range In Cm 54 137 2 31 6 127 190 190 253 253 316 55 139 7 33 ...

Page 53: ...T Range In Cm 60 152 4 50 200 300 300 400 400 500 61 154 9 52 3 209 314 314 418 418 523 62 157 5 54 6 218 328 328 437 437 546 63 160 56 9 228 342 342 455 455 569 64 162 6 59 2 237 355 355 474 474 592 65 165 1 61 6 246 369 369 492 492 616 66 167 6 63 9 255 383 383 511 511 639 67 170 2 66 2 265 397 397 529 529 662 68 172 7 68 5 274 411 411 548 548 685 69 175 3 70 8 283 425 425 566 566 708 70 177 8 7...

Page 54: ... to the selected type of humidifier It is also possible to change the type of humidifier once the ventilator has started ope rating Menu Ventilatory adjuncts Humidifier Fig 5 2 Initial calibration state where it is possible to select the humidification system After accepting the type of humidifier the screen will display the instructions to start the patient circuit calibration For calibration use...

Page 55: ...enough pressure the ventilator will not accept the initial calibration the calibration is not feasible using only air Calibration of the patient circuit de pends on the ambient pressure From Menu Tools Settings Mean ambient pressure it is possible to enter manually the value of the mean ambient pressure where the ventilator is installed Ensure that this value is suitable for the calibrations to be...

Page 56: ...e the equipment carries out volume compensations that are essential for the effec tive functioning of the ventilator See Menu chapter to learn the procedure Fig 5 5 Calibration of the patient circuit in progress The patient circuit integrity is checked at the beginning of the calibration When a continuous leak occurs from any part of the circuit and is less than 10 L min the message appearing in F...

Page 57: ...e equipment will fail the calibration stage and will not start operating Fig 5 7 Fig 5 7 On screen message showing a leak greater than 10 L min during calibration WARNING In the event of a significant leak check the patient circuit to detect the section with the leak Replace or repair the segment to pre vent any improper change in ventilation If while performing the calibration circuit the airtigh...

Page 58: ...following cases The gas entering the OXYGEN inlet is not oxygen or its concentration is not ade quate The sensor is exhausted Fig 5 9 On screen message showing an O2 sensor calibration failure NOTE Recalibration of the patient circuit during ope ration of the ventilator must be carried out by disconnecting the patient circuit and occluding the opening of the Y shaped connector Take precautions to ...

Page 59: ...hich heavily depends on the amount of oxygen that it has been exposed to The equipment works correctly with an exhausted oxygen sensor but in this case is not possible to monitor the O2 concentration The ventilator injects known volumes in the tight circuit and records the pressure levels generated by these volumes In this way the circuit calculates the patient circuit compliance for the different...

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Page 61: ...Upon completing the initial calibration process iTernIS ADV allows the configura tion of an interesting variety of ventilation functions This chapter describes how to configure and program the equipment main functions such as selecting an opera tive mode its configuration entering and exiting the Standby mode and program ming additional functions for ventilation in specific modes The functions acc...

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Page 63: ...ditional functions The screen has a series of buttons that function as direct access to different ventilation functions Graphics scaling The scale of the graphics can be changed by pressing one of the axes of the graphics shown on the screen See the Graphics Management chapter WARNING Do not use sharp objects like pens or scis sors on the touch screen or the fixed keys Only fingertips should be us...

Page 64: ...entilator is used or if it was transferred to a new city the Mean Ambient Pressure value must be set The equi pment uses this value to carry out important vo lume compensations that are essential for the efficient functioning of the ventilator See the Menu chapter to learn about the procedure Each operative mode has a characteristic group of ventilatiory parameters see the Operative Modes for ADL ...

Page 65: ...h no programed mandatory respiratory rate the cha racteristics for a Backup Ventilation must be configured to ensure that the venti lator continues ventilating the patient in case his her respiratory efforts cease In other operative modes it is an optional configuration If a mode requiring Backup Ventilation is selected for the first time after the ventilator is turned on the following steps must ...

Page 66: ...TION menu at any time and modify the configu ration carry out the following sequence Menu Backup Ventilation A window appears on the scree n similar to the one shown in the third image of Fig 6 4 where the Backup Ventilation characteristics can be modified Later on the Menu chapter describes this modality in greater detail Fig 6 4 Navigating menus for configuring Backup Ventila tion for the first ...

Page 67: ...nctions that modify the final configuration of an operative mode are described in the section below 6 5 Additional Functions Some examples of these functions are nebulization sighs inspiratory pause vo lume compensation etc To put the ventilator on STANDBY press the Standby button on the right side of the screen and accept using the knob This status leaves the ventilator charged but not ventilatin...

Page 68: ... different ways By time 30 minutes after the function is activated Voluntarily By pressing the Nebulizer key Automatically by the ventilator If during nebulization the peak flow does not reach an adequate value to be compatible with nebulization the nebulization is interrupted This event is accompanied by low priority alarms Interrupted Nebulization alarm Nebulization is enabled for all operative ...

Page 69: ...lues for each variable are found in the Menu chapter Fig 6 7 Window showing the Suction O2 in pro gress This function freezes the screen immobilizing the status of the current graphics It is activated by pressing the Freeze button on the ventilator screen To unfreeze the screen press the Esc key This function is enabled in all modes and for the three patient categories The frozen screen is saved i...

Page 70: ...ttom row and the knob stay active while the screen is locked The Screen Lock key is illuminated when it is pressed for 2 seconds indicating that the lock is active If the touch screen or one of the locked keys is touched while locked the Screen Lock key emits a small burst of blinking lights and displays a message on the screen indicating that the screen is locked To unlock the screen press the Sc...

Page 71: ...meter is found in all operative modes and represents the fraction of oxygen contained in the gas mix that the ventilator sends to the patient INSPIRATORY SENSITIVITY Sens this is a parameter that characterizes the least or greatest effort that the patient should make in order to initiate a spon taneous or assisted breath The configuration of an inspiratory sensitivity value determines the magnitud...

Page 72: ...ed flow the pressure and volume curves are similar to those in the pressure controlled mode PCV However in modes controlled by volume the flow descent is calculated and respected regardless of the mechanics of the patient s respiratory system In PCV the flow descent is the result of respiratory im pedance through which the flows travel In VCV the preset flow wave is a descending ramp Fig 6 8 Image...

Page 73: ...ssure PSV and con trolled pressure PCV are combined the regula tion of rise time affects both types of breaths EXPIRATORY SENSITIVITY Exp Sensitiv this parameter allows adjusting the criterion for the inspiratory period end according to the magnitude of the current flow Expiratory sensitivity is programmed as a percentage of the peak flow There fore the end of inspiration is produced when the inst...

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Page 75: ...Backup ventilation 7 4 Ventilatory adjuncts 7 5 Records 7 6 Tools 7 7 Intra hospital transport 7 CHAPTER SUMMARY This chapter describes the ventilator main menu functions Menu key The des cription includes a functional explanation and the use and configuration instruc tions for each of them ...

Page 76: ...Menu iTernIS ADV 7 2 This Page Left Intentionally Blank ...

Page 77: ...ight upper corner of the same window To show the hidden page turn the knob as long as no other functions are open The respiratory mechanics data shown in the lower corner of number 1 window only display information if the corresponding test has been performed before When a parameter has three hyphens instead of a number it means that the infor mation is not available or the current operative mode ...

Page 78: ...bled Dynamic compliance Cdyn It shows the dynamic compliance calculation perfor med breath to breath The Respiratory Mechanics chapter describes how this parameter is calculated Imposed Work Of Brea thing WOBi It indicates the work performed by the patient to trigger spontaneous inhalations It is expressed in mJ min The measurements are updated every mi nute To obtain the first reading a minute of...

Page 79: ...entilation The displayed window changes three pa rameters OPERATIVE MODE the breaths provided in Backup Ventilation may belong to different operative modes For ADL PED patients the options are VCV and PCV The possibility of TCPL is added in NEO INF as a backup APNEA TIME defined as the time elapsed from the last breath triggered by the patient until the ventilator determines that there is an apnea...

Page 80: ...ng used these functions will be enabled or disabled In the latter case the appropriate line on the VENTILATORY ADJUNCTS menu is displayed in a lighter color than the lines that represent the enabled functions There is a rapid access to access this window Pressing the Menu key twice in a row brings the window shown in Fig 7 4 to the screen 7 4 This window shows different options based on the type o...

Page 81: ...t that has an effect only in breaths with sighs In this way the maximum pressure alarm and the maximum pressure limit take the new value configured here only for breaths with sighs The maximum pressure can be configured from 10 cmH2 O to 120 cmH2 O at 5 cmH2 O intervals ACTIVATED this line activates YES option the sighs with the configured values or it disables them NO option Fig 7 5 SIGHS window ...

Page 82: ...o generate a pressure in the patient circuit higher than the configured one whose magnitude is calculated ac cording to the following equations Ptracheal Configured pressure PCV o PSV Paw Ptracheal Paw Ptracheal Pcomp Ptracheal Paw Pcomp Pcomp K Flow2 compensation Where Pcomp is the pressure level added to the pressure in the circuit Paw to compensate for the resistance of the tube K is a coeffici...

Page 83: ...pressurizes the circuit down to the configured PEEP level WARNING Because this modality works as an amplified pressure control system it is very important to perform an appropriate adjustment of the compensation percentage Rise Time and tube diameter in order to avoid excessive compensation that may result in exceeding airway pressure Tube compensation is used for ADL and PED category patients in ...

Page 84: ...turated ambient pressure The humidification system options are ACTIVE this is the option that must be configured when an active humidifier heater is used In this case flow and volume readings are corrected to take into account the humidity and temperature generated by this kind of humidifier PASSIVE this is the option that must be configured if a passive humidifier is used heat and moisture exchan...

Page 85: ...correctly connected before enabling it For each pneumotachograph change the ventilator automatically runs a zeroing procedure on its flow sensors PRECAUTION The proximal pneumotachograph must be con nected before being enabled Otherwise the ven tilator will not receive information about exhalation flow This will result in the ventilator not operating appropriately The position of the pneumotachogr...

Page 86: ...curves according to the size of the area assigned for each graph The description of the Autoscale function is in the Graphics management chapter Entering Menu Tools Suction configuration gives access to the window where the Suction period and the O2 enrichment can be changed see Table 7 4 Fig 7 10 The Suction period determines the time allocated to suction during which the ven tilator does not pro...

Page 87: ...eters can be found in Table 7 4 Table 7 4 Suction configuration Category Suction period Absolute O2 enrichment Range Increase Initial value Range Increase Initial value ADL PED 10 40 5 20 5 20 Max 5 Max NEO INF 10 40 5 10 5 20 Max 5 10 Fig 7 10 SUCTION CONFIGURATION window Fig 7 11 shows the functions included in the CALIBRATIONS window Fig 7 11 CALIBRA TIONS menu Entering this option displays a s...

Page 88: ...ardous situations may arise for the patient All capnography related information has been included in the Capnography chapter From here it is possible to change the units of pressure used in the readings and graphs involved in this measurement The available units are cmH2 O mbar and hPa The numeric values are not changed since the ratios between these units is approximately 1 1 The flow and volume ...

Page 89: ...ltitude Table 7 5 can be refe rred to as a general guideline Table 7 5 Atmospheric Standard International Civil Aviation Organization ICAO Altitude m Atmospheric pressure mbar mmHg 0 1013 760 500 955 716 1000 899 674 1500 845 634 2000 795 596 2500 747 560 3000 702 525 3500 658 493 4000 616 462 4500 577 433 The sound of the alarms can be regulated From Menu Tools Settings Sound volume it is possibl...

Page 90: ...ges the language of the ventilator program When the language is changed all functions and tags displayed on the iTernIS ADV screen will change to the new language Available options are SPANISH ENGLISH PORTUGUESE RUSSIAN CHINESE FRENCH TURKISH This option leads to a window that shows the version of the ventilator software the total number of hours used and the time elapsed since it was last service...

Page 91: ...ly be activated when the air supply is missing The Intra Hospi tal Transport activation mechanism is as follows Shut down the wall O2 supply the ventilator temporarily ventilates with air only and remove the ventilator hose Make the connections that feed the OXYGEN inlet into the ventilator from an O2 tube Shut down the wall air supply and remove the feed hose this will trigger the Low air pressur...

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Page 93: ...8 4 Autoscale 8 5 Horizontal axis position zero line 8 6 Reference loops 8 CHAPTER SUMMARY Graphics management includes instructions to correctly configure pressure volu me and flow curve and pressure volume and volume flow loop graphs The chapter descriptions include screen graphic layout configuration scale management units reference loops etc ...

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Page 95: ...menu The pictures included in the Fig 8 1 window represent the different screens They are FIVE CURVES Pressure volume and flow and pressure volume and flow volu me loops This is the default iTernIS ADV screen This is the screen displayed at the start of ventilation and pressing the Esc key brings the system back to this screen TWO CURVES Pressure and flow THREE CURVES Pressure flow and volume LOOP...

Page 96: ...Graphics management iTernIS ADV 8 4 Fig 8 2 FIVE CURVES screen Fig 8 3 TWO CURVES screen Fig 8 4 THREE CURVES screen 8 1 1 Five curves 8 1 2 Two curves 8 1 3 Three curves ...

Page 97: ...Graphics management iTernIS ADV 8 5 Fig 8 5 LOOPS screen Fig 8 6 PATIENT S DATA screen Fig 8 7 CAPNOGRAPHY screen 8 1 4 Loops 8 1 5 Patient s data 8 1 6 Capnography ...

Page 98: ...anged The way to change scales is the same for all screen graphs The change in progress can be aborted at any time by pressing the Esc key When the scale of a given magnitude is changed all the axes that show that mag nitude are simultaneously changed For example if the Pressure axis on the first FIVE CURVES graph is changed the volume pressure loop pressure axis is also changed An alternative to ...

Page 99: ... of the touch screen Pressing this button freezes the current loop in another color on screen showing the date and time it was recorded over the VT Paw loop area Four loops with dates and times can be stored in the ventilator memory by repeatedly pressing the Save loop button They remain in the memory until the ventilator is turned off To access them execute the following string Menu Records Saved...

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Page 101: ...V Mandatory Minute Ventilation with Pressure Supported Ventilation 9 8 PSV with assure VT 9 9 APRV Airway Pressure Release Ventilation 9 10 NIV Noninvasive Ventilation 9 11 PRVC Pressure regulated volume controlled ventilation 9 12 Backup Ventilation 9 CHAPTER SUMMARY iTernIS ADV uses the same operative modes for the ADL and PED patient cate gories Therefore a brief description of the modes found ...

Page 102: ...ADL PED Operative modes iTernIS ADV 9 2 This Page Left Intentionally Blank ...

Page 103: ...f the breathing in VCV is controlled by the respiratory rate control If the patient generates enough respiratory effort greater than or equal to the con figured inspiratory sensitivity the start of the inspiratory periods is determined by these efforts rather than by the respiratory rate For this reason the VCV mode is also known as an assisted mode The inspiratory sensitivity can be configured by...

Page 104: ...essure mode PCV the iTernIS ADV ventilator functions as a positive pressure controller In this mode the pressure is set from the PCV parame ter and this value remains unchanged regardless of the patient compliance and re sistance The PCV value is applied above PEEP peak pressure PCV PEEP The regulated control pressure is kept constant during the set inspiratory time In order to maintain constant p...

Page 105: ...ted PEEP level This means that the ins piratory pressure Pi is the sum result of both pressure values Pi PCV PEEP In pressure controlled modes including PSV a Rise Time control appears Control Adjustment sector This control allows changing the time it takes for achieving re gulated control pressure Changes to the rise times can be seen graphically as an increase or decrease in the slope of the ini...

Page 106: ...ith Inspiratory Sensitivity control it is possible to configure di fferent trigger conditions that imply more or less effort for the patient INSPIRATION COURSE once the inspiration is triggered it is necessary to pro duce the pressurization of the respiratory system and that the support pressure value is maintained throughout the patient s demand The pressurization can be changed quickly with Rise...

Page 107: ...itivity is programmed as a percentage of peak flow The inspiration end is produced then when the instan taneous flow has reached a level equal to the configured peak flow rate Rise Time may be adjusted in breaths with support pressure see Basic Operations chapter Fig 9 8 Image of the PSV enabled controls ADL and PED category Shown with the preset values for each of them The following list contains...

Page 108: ...tory efforts it assumes an apnea state starting Backup Ventilation CPAP is a particular way to set the PSV operative mode Therefore achieving ventilation with CPAP features only requires configuring a PSV level of 0 cmH2 O so that there are no breaths with support pressure Fig 9 9 Image of the PSV CPAP mode controls configured to deliver breaths with CPAP features Except PSV the rest of the parame...

Page 109: ...uiring the ventilator to synchronize this effort with mandatory breaths Fig 9 10 Mode SIMV VCV PSV Captured image during ventilation in ADL category A breath of VCV type A has been highlighted and two spontaneous breaths B The configuration of the Rise Time affects spontaneous breaths that are delivered with support pressure while changing the flow waveform only affects the manda tory breaths VCV ...

Page 110: ...milar to SIMV VCV PSV with the diffe rence that the mandatory breaths are thus supplied with controlled pressure The synchronization of spontaneous and mandatory breaths is performed in the same manner as that described in 9 5 Inspiratory time and regulated rate control the mandatory breaths which in this case are of PCV type Fig 9 13 SIMV PCV PSV mode Captured image during ventilation in ADL cate...

Page 111: ...arget minute volume is not reached the ventilator adjusts the PSV value breath by breath to achieve the required target ventilation PSV variations are progressi ve and do not represent abrupt changes between consecutive breaths not excee ding 2 cmH2 O between breaths Because it is a spontaneous mode the rate of breaths and the magnitude of pa tient demand can vary continuously Naturally the minute...

Page 112: ...m limits Warning signals are triggered notifying this event The alarm is for Target Volume not reached and is of medium priority see Alarms chapter Fig 9 17 Preset controls for ADL category Fig 9 18 Preset controls for PED category The following list contains additional functions that can be selected optionally in MMV PSV for further details on their behavior see the Menu chapter Nebulization O2 s...

Page 113: ...mmediately to a constant flow in order to complete the target volume When the minimum tidal volume is reached the cycling is produced The constant flow is maintained until the target volume is reached or until inspira tory times of 3 0 s for ADL and of 1 5 s for PED have elapsed This is added as a safety mechanism to prevent excessive inspiratory times Table 9 1 summarizes the behavior of the vent...

Page 114: ...inspiration Volume compensation Leak compensation This is a mode that uses two adjustable levels of continuous positive pressure high and low PEEP for extended regulated periods of time upper Ti and lower Ti The two levels of positive pressure produce passive and intermittent distention and decompression of the lungs At all times the patient can perform spontaneous breathing with or without suppor...

Page 115: ... 9 23 Preset controls for ADL and PED categories Four special parameters exist already for this mode setting High and low PEEP and high and low Ti These 4 parameters are used to define the levels of conti nuous positive pressure and the duration of each of these levels The following list contains additional functions that can be selected optionally in APRV for further details on their behavior see...

Page 116: ...e Table 17 7 This is one of the mechanisms which assure the stability of the regulated pressure the stabilization of the trigger sensitivity avoiding auto triggering and the control of respiratory syn chronization The end of the inspiration has two criteria for implementation The first addresses the expiratory detection configuration If this criterion is not met the inspiration may end during a pr...

Page 117: ...tomatically progressive pressure changes to try to reach the target volume These pressure increases or decreases do not exceed 3 cmH2 O per breath The mechanism for determining the necessary pressure first breath with VCV and inspiratory pause will occur whenever PRVC mode is accessed The target tidal volume is changed A standby state is restored The VT obtained by the patient exceeds by 100 the t...

Page 118: ...libration chapter The images of Fig 9 28 and Fig 9 29 show the initial values resulting from the preset IBW based VT con figuration The following list contains additional functions that can be selected optionally in PRVC for further details on their behavior see the Menu chapter Nebulization O2 suction Manual inspiration Manual inspiratory expiratory pause Volume compensation Leak compensation Tub...

Page 119: ...ventilation and its configuration It is not strictly an operative mode such as those described in this chapter This is a safety tool that is used in conjunction with the spontaneous mo des to provide ventilation in the event of apnea or decreased ventilatory effort 9 12 Backup Ventilation 9 12 1 Overview ...

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Page 121: ...led Pressure Limited Ventilation 10 8 SIMV VCV PSV Synchronized Intermittent Mandatory Ventilation 10 9 Continuous flow CPAP 10 10 PRVC Pressure Regulated Volume Controlled Ventilation 10 11 Backup Ventilation 10 CHAPTER SUMMARY This chapter describes the operative modes available for neonatal infant patients In NEO INF there are modes that are not available for ADL PED patients and it also lacks ...

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Page 123: ...ased on the selected VT and Ti The airway pressure varies and depends on the mechanical characteristics of the respiratory system If there is a spontaneous requirement from the patient Inspiratory sensitivity the ventilator helps the patient by synchronizing the start of the inspiratory phase with the respiratory effort NOTE The ADL PED Operative Modes chapter has a more detailed description of th...

Page 124: ...to ventilate with a constant pressure that can be configured by the user The ventilator works as a pressure controller and the pressure wave stays unchanged by respiratory system impedance changes It is the flow that adapts to these changes to ensure that the target pressure is maintained It is time cycled The tidal volume delivered for each breath is variable and depends on the respi ratory syste...

Page 125: ...sation Leak compensation Distal proximal pneumotachograph This is a spontaneous mode where the patient can start and terminate the ins piratory phase The operation and configuration characteristics of this mode are identical to those described in the ADL PED Operative Modes chapter See that chapter for specific details regarding the PSV CPAP mode That chapter breaks them down into two independent ...

Page 126: ...D category A mandatory ventilation is configured controlled by the ventilator while spontaneous breaths are allowed The two types of breaths are synchronized to eliminate inspiration efforts during mandatory breaths The important characteristics of this mode are VCV mandatory breaths The VT respiratory rate and inspiratory time are confi gured Mandatory respiration rate and expiratory time can var...

Page 127: ...le Fig 10 8 Picture of the SIMV VCV PSV enabled con trols NEO INF category Shown with the preset values for each The preset values of the tidal volume will depend on the configuration of the IBW based VT see the Start up and Initial Calibration chapter Fig 10 8 shows the initial value that result from a IBW based VT default configuration The following list has complementary functions that can be s...

Page 128: ...ied out following the support pressure breathing principles It is therefore necessary to configure the PSV parameters to ensure that support is present in the breath triggered by the patient Backup Ventilation is disabled by default In this case it must be ensured that the patient will receive ventilation that is at least equal to the configuration of the mandatory PCV breaths It can be enabled by...

Page 129: ...gulation inverted I E ratio ventilation can be administered Configuring Backup Ventilation is optional in this mode Fig 10 11 APRV screenshot in NEO INF The picture shows that two spontaneous breaths have been carried out during the first high PEEP period and another spontaneous respi ration has been charted for the following low PEEP period Fig 10 12 Picture of the APRV enabled controls NEO INF c...

Page 130: ...d pressure determines the maximum limit it can reach Therefore the PEEP addition does not change the maximum pressure peak obtai ned This way the TCPL mode in the iTernIS ADV ventilator adheres completely to the classic programming style that this mode has followed for a long time Fig 10 13 TCPL screenshot Fig 10 14 Picture of the TCPL enabled controls NEO INF category Shown with the preset values...

Page 131: ...rion as with the other SIMV modes The patient s inspiratory effort can trigger spontaneous breaths and can also initiate breaths with mandatory cha racteristics TCPL in this mode if the patient s requirement is registered as being close to the moment a mandatory breath is about to start as determined by the regulated frequency This prevents patient ventilator asynchrony resulting in a more comfort...

Page 132: ... triggering the appropriate alarm signals In this mode leakage compensation is enabled by default It must be understood that the selection of high continuous flows can raise the pressure baseline due to the more or less constant resistance presented by the entire respiratory system Due to this resistence a flow increase results in an in crease in the difference in ingoing outgoing pressure Therefo...

Page 133: ...s At the beginning of this mode the ventilator provides the patient with a program med target volume VCV breath and a 0 5 s inspiratory pause A constant rectangu lar flow wave is used for this first breath This way the ventilator can calculate the system compliance and from there establish the pressure level needed to reach the target tidal volume Then the ventilator starts delivering pressure con...

Page 134: ...on must be made at the time of regulating the maximum pressure alarm limit because it determines the maximum au tomatic pressure regulation level It cannot be configured below PEEP 10 cmH2 O The PEEP cannot be configured above 10 cmH2 O below the alarm limit Fig 10 20 PRVC enabled controls Shown with the preset values for each The preset values of the tidal volume will depend on the configuration ...

Page 135: ...pensation Distal proximal pneumotachograph The Menu chapter describes the characteristics of this type of ventilation and its configuration Strictly speaking it is not an operative mode like those described in this chapter It is a safety tool used along with the spontaneous modes to ensure ventilation in case of apnea or a ventilation effort decrease ...

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Page 137: ...ative ventilator 11 7 High priority alarms 11 8 Medium priority alarms 11 9 Low priority alarms 11 CHAPTER SUMMARY The Alarms chapter has the information needed to know and manage the iTernIS ADV alarm system This includes information about the structure of the alarm system how to manage its configuration the notification and message sys tem and the specific characteristics of each alarm condition...

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Page 139: ...r one or both gases loss of patient circuit integrity disconnection When the alarm signals for a given condition are active it is possible to access a help message for that alarm by pressing the Ctrl Alarm Limits key The message lists the possible causes and in some cases includes a recommendation for corrective action All alarm events occurring while the ventilator is in operation are stored in t...

Page 140: ...ights up to indicate an Inope rative Ventilator condition Alarm Signals middle LED Front panel Red It lights up to indicate high priori ty alarm conditions Alarm Signals lower LED Front panel Yellow It lights up to indicate medium low priority alarm conditions Upper light indicator Upper side of the console Red Ye llow It lights up at the same time as the Alarm Signals sector indica tors The color...

Page 141: ...hen it is triggered the ventilator becomes inoperative and the screen stops working Once the alarm condition has disappeared the alarm signals behave differently When an alarm condition has stopped and the alarm signals persist they are called maintai ned signals On the other hand if the signal ends at the same time as the condition it is a non maintained signal If there are one or more maintained...

Page 142: ...ing generated All auditory signals can be paused except for the signal generated during Emer gency Ventilation and the Inop Vent signal At the beginning of an alarm signal audio paused period an icon appears on the screen with the same symbol characteristics found on the audio paused key Alarm limits are adjusted with an alarm regulation direct access key This key can be found under Alarm Limits o...

Page 143: ...arms A deactivated alarm generates no alarm signals and cannot configure its limits When an alarm is deac tivated a record of the ACTIVATED ALARMS screen is kept see 11 2 Alarm event record In ADL patient category it is possible to deactivate the following alarms in NIV Non Invasive Ventilation mode Tidal Volume Minute Volume When one of these two alarms is deactivated the other one is automatical...

Page 144: ... SIMV APRV YES Backup Ventilation and the Apnea alarm are deactivated by default for these modes This alarm is described apart from the other alarm conditions because it has spe cific characteristics It is the highest priority condition because the triggering of the signals of this alarm means that the ventilator has become inoperative The ventilator is not capable of providing ventilation for a p...

Page 145: ...aneously low O2 and air In all modes Immediate signal activation when both supply gas pressures fall below 200 kPa 2 bar Low oxygen or air pressure Cannot be adjus ted by user Low pressure in one of the O2 or air supply gases In all modes Immediate signal activation when the supply pressu re of one of the gases drops below 200 kPa 2 bar The gas that has appropriate pressure replaces the one that l...

Page 146: ...rs There is no main line power The cord that connects the machine to the main line is unplugged Burnt out intake fuse In all modes Instant alarm signal activation Simultaneously switches to internal battery supply High low O2 con centration Maximum or minimum O2 limit concentration in the mixture of gases de livered by the ventilator In all modes Alarm signal activation when the O2 concentration s...

Page 147: ...set In all modes Alarm signal activation after the pressure drop stays below PEEP for 15 s Nebulization interrupted Cannot be ad justed by user Nebulization interrup tion due to the absen ce of enough flow of gases It operates in modes where nebulization is enabled and only when this function is active Alarm signal activation when insufficient flow is de tected This is accompanied by the effective...

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Page 149: ...and resistance 12 3 Trapped Volume 12 4 Slow Vital Capacity 12 5 P0 1 12 6 PV flex inflection points 12 7 Pimáx 12 8 VD VT Physiologic 12 CHAPTER SUMMARY iTernIS ADV allows testing standards for characterizing the patient s respiratory mechanics This chapter describes the concept and how to carry out each test ...

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Page 151: ...rmed With the iTernIS ADV ventilator the auto PEEP measurement is performed through a static maneuver The patient must be kept in controlled ventilation volume or pressure Respiratory efforts may alter the measurement therefore if the patient is alert it is important to instruct him her on the procedure to obtain maximum re laxation during the maneuver On the first step the ventilator closes the e...

Page 152: ... occurs during the insufflation of a known volume according to the following formula VT Dynamic Compliance Pmax PEEP Dynamic Compliance is a global index that refers to the patient s respiratory impe dance in general without distinction of its elastic and resistive components In this ventilator dynamic compliance is shown in real time breath by breath in the screen corresponding to PATIENT S DATA ...

Page 153: ...me ha ppens in VCV mode with a downward flow wave Measuring Expiratory Resistance is useful in assessing response to bronchodila tors in ventilated patients suffering from obstructive respiratory diseases The formula used for calculation is as follows CTest Expiratory resistance Static compliance Expiratory resistance evaluates the resistive characteristics of the airways during expiration so that...

Page 154: ...EEP intrinsic PEEP has been detected NOTE Assisted and spontaneous modes are not stu died If the patient performs spontaneous brea thing the trapped volume calculation is not per formed To make the measurement the iTernIS ADV ventilator performs a static maneuver The patient must be kept in controlled ventilation volume or pressure Respiratory efforts alter the measurement therefore if the patient...

Page 155: ... of the win dow is shown after having implemented a test with the latest obtained values For the first time after turning the equipment on this will not show any results Vital capacity is the amount of air that can be expired after a maximal inspiration serving as a ventilatory reserve assessment This test is only enabled for ADL and PED patient categories To perform the maneuver the ventilator au...

Page 156: ...d in the test are displayed In this case with the last breath the full slow capacity has been achieved so the Current and Better values match The objective of this test is to help determine the ventilatory demand and the ca pacity of the patient to resume spontaneous ventilation By definition the P0 1 determines the pressure drop generated by the patient s effort during the first 100 ms after the ...

Page 157: ...VCV PCV PSV CPAP SIMV VCV PSV SIMV PCV PSV MMV PSV PSV assured VT APRV NIV PRVC Respiratory Mechanics P0 1 After implementing this string the test window appears on the screen Pressing the rotary knob starts the maneuver to finish at the P0 1 measurement Once the result is displayed on screen it is possible to perform the test again During the implementation of the test it is possible to cancel th...

Page 158: ...middle section of the curve Cmax This test is only enabled for the ADL and PED patient categories The patient must be intubated and without exerting inspiratory efforts during the test The ventilator injects a low flow into the patient and monitors the pressure behavior of the respiratory system in relation to the entered amounts The inflection points are located at the site of the curve where the...

Page 159: ...ion of the test it is possible to cancel the maneuver by pressing Esc Fig 12 6 Picture of a PV flex test The graph shown was generated from a test mechanical lung with a compliance change simulator As a result the changes in the curve can be seen very clearly defined The Pimax is an index that evaluates the maximum contractile capacity of the ins piratory muscles especially the diaphragm The Pimax...

Page 160: ...ics Pimax After implementing this string the test window appears on the screen Pressing the rotary knob starts the maneuver that performs the measurements of maximal inspiratory pressure during 20 s At this time all ins piratory efforts are monitored and in the numerical data window the highest value obtained in the series of efforts is recorded Once the test concludes it is possible repeat it If ...

Page 161: ...CV PSV MMV PSV PSV assured VT APRV NIV PRVC Respiratory Mechanics VD VT physiologic After implementing this string the test window appears on the screen From here the steps to obtain the value of the physiological dead space are Press the rotary knob to record the current PECO2 of the patient Perform sampling of the arterial blood that would allow through the relevant analysis obtaining the PaCO2 ...

Page 162: ...Respiratory mechanics iTernIS ADV 12 14 Fig 12 8 VD VT physiologic test screen ...

Page 163: ...t 13 CHAPTER SUMMARY This chapter summarizes the information needed to know the features of the trend system that has been implemented in iTernIS ADV The trend history system of the monitored parameters can be viewed at any time and the user can configure the information it shows These operations are explained in this chapter ...

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Page 165: ... shown in each of these groups The different variables are followed up with updates in steps every one minute Each new value added to the trend graphs represents the average value of the parameter during that minute The curves tracing changes its color when a new ventilation day begins date update This allows to quickly identify the trends that have been recorded for different days The parameters ...

Page 166: ...enu The submenu shown in Fig 13 2 is displayed through this option Fig 13 2 Trend settings submenu Each trend line can be configured to show any of the 9 parameters available for trends Each trend group can be configured from this submenu There are 9 possible para meters to set in trends Any of them can occupy the first second or third position in TREND 1 2 or 3 The positions in which the paramete...

Page 167: ...ving the cursor modifies the path to be followed by the curves Pressing the horizontal axis of one of the trends so as to change the horizontal scale of the graph and the Ctrl key the order does not matter makes it possible to move along the time axis without changing the scale This aims at allowing to view data recorded a long time ago Turning the rotary knob generates time movements It may be us...

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Page 169: ...ph 14 3 Monitoring 14 4 Capnography Menu 14 5 Messages 14 CHAPTER SUMMARY The chapter includes information on how to enable the optional module of capno graphy how to interpret the information provided by the ventilator how to manage its menu settings and information about the equipment used to assess data ...

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Page 171: ...nograph which links the Y shaped piece with the connection elements to the patient Fig 14 1 Left capnograph connected to the Y piece of the patient circuit Right capnograph cable connected to the ventilator Fig 14 2 Capnograph adapter The image shows one of the two circular windows featuring this device arrow PRECAUTION Keep windows of the capnograph adapter free from dirt to assure correct readin...

Page 172: ... and selecting the CO2 screen On the CAPNOGRAPHY screen it is possible to display the following curves in a continuous form PCO2 vs Time under the pressure volume and flow curves Volumetric capnography on the right below the box showing the monitored para meters iTernIS ADV allows continuous monitoring of these parameters on the Capnogra phy screen ETCO2 partial pressure of CO2 at the end of exhal...

Page 173: ...s option YES or disables option NO the plotting of the CO2 curves on the capnography screens This is enabled by default YES If the sensor is connected to the ventilator but the status message is ERROR Ac tivate Sensor it should then be activated manually Menu Tools Calibratio n Capnography Sensor Initialization During the activation process data of barometric pressure is sent as well as oxygen com...

Page 174: ...lows for the reset without having to disconnect and reconnect the sensor Next messages which may appear during the use of the capnography module are defined as well as detailed recommendations on necessary actions CO2 NO BREATH DETECTED This message appears in the case of failing to detect breaths containing CO2 CO2 OUT OF RANGE Appears when the value of CO2 is detected as being superior to that o...

Page 175: ...eing executed ZERO REQUIRED This is displayed when problems occur during a reset to zero dirty adapter for example Repeating the reset to zero of the adapter is suggested SENSOR WARM UP The sensor has not yet reached the operating temperature or temperature is uns table which can occur at the beginning of the operation OVERHEATED SENSOR Internal temperature of the sensor is above the operating ran...

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Page 177: ...15 1 Necessary items 15 2 Ventilator preparation 15 3 Functional verification 15 4 Alarms Verification 15 5 Operative Verification 15 CHAPTER SUMMARY This chapter lists a series of tests to be performed on the ventilator in order to de termine whether it is in good operating condition ...

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Page 179: ... as well as the electric power source cable to the appropriate sources Verify the presence of O2 cell Turn on the ventilator and choose the appropriate corresponding patient cate gory Begin the patient circuit calibration as indicated in the chapter Ignition and initial calibration When the programming screen appears select the operative mode VCV Ventilation begins by accepting the default paramet...

Page 180: ...ve mandatory breaths Manual inspira tion Press Manual Insp The ventilator should initiate a mandatory breath Flow waveform Change the flow waveform On the flow chart the profile change of the flow wave forms should appear Oxygen Compare the monitored O2 concentration with the regular concentration The monitored value should be between 45 and 55 Oxygen Change the concentration of O2 up to a value o...

Page 181: ... Apnea Select the PSV ventilation mode without changing the menu Backup Ventilation Squeeze the test lung only once to generate sponta neous breathing Then sus pend the generated sponta neous breathing 15 s after the last sponta neous breath Apnea alarm signals should appear and the ventilation mode must change from PSV to the configured mode of Backup Ventilation Electric power failure Disconnect...

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Page 183: ...enance 16 CHAPTER SUMMARY There are a number of recommendations as to the conditions of cleaning sterility and maintenance to be met for the equipment and its accessories This chapter is dedicated to presenting the necessary guidelines on the subject of maintenance and key points which must be addressed in order to ensure the proper functioning of the ventilator ...

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Page 185: ...emical solvents nor acid based or alkaline subs tances Use a soft cloth soaked in a solution of neutral detergent and water A solution containing 80 of isopropyl alcohol can also be used Never use substances which contain ammonia Do not spray the cleaning product directly onto the screen Apply the chosen substan ce onto a soft cloth with which to wipe the screen All parts of the patient circuit mu...

Page 186: ... not immerse the base of the humidifier heater in any type liquid Danger of short circuiting may be present Refer to the humidifier heater manual for the cleaning and sterilization of the device To clean the set before the sterilization process only use mild chlorine free de tergents Instructions on how to remove the set from the ventilator and on how to dismantle it are found in the chapter Assem...

Page 187: ...0 autoclaving cycles if the following parameters are selected 20 minutes at 121 C 2 hours or 15 minutes at 134 C 1 5 hours The components will be in proper working condition once they have been duly cleaned and sterilized Pay particular attention to the assembly of all parts of the patient circuit specially to the expiratory set The diaphragm of the set must be assembled correctly in order to func...

Page 188: ...of water in the filter Drain if nec essary Daily Patient circuit Check status of overall circuit hoses accesso ries Replace the parts or accessories that are not in optimal conditions and recalibrate the pa tient circuit Every 3 months Internal battery Disconnect the main power cable Verify that the icon Full battery charge remains for 10 minutes If this does not occur contact your au thorized ser...

Page 189: ...eing necessary use fuses of the same characteristics Fig 16 3 Relative loca tion of the fuse box A in relation to the main electric power source input B The scheduled maintenance is performed every 5000 hours of usage or every year whichever comes first This is a procedure performed in the factory or by an authorized service technician When the computer is sent out for maintenance include a note e...

Page 190: ...afety related controls 6 MPBetreibV and the metrological controls 11 MPBetreibV have to be conducted according the EU Guideline 93 42 EEC Periodical safety related controls must be conducted according to the conditions of DIN EN 60601 1 based on the intervals prescribed by the manufacturer The safety relevant controls include the functional and operational safety Only authorized personnel must con...

Page 191: ...tored Parameters 17 9 Alarm Adjustment 17 10 Data Collection for Control and Monitoring 17 11 Electromagnetic Compatibility 17 12 Basic Operation of the Ventilator 17 13 Safety Mechanisms 17 14 Diagram of the Pneumatic Circuit of the Ventilator 17 15 Lifetime 17 CHAPTER SUMMARY This chapter summarizes the technical specifications that characterize iTernIS ADV Some examples are physical electrical ...

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Page 193: ...23 2 in Table 17 3 Screen Type Resistive sensitive touch screen color TFT LCD Size 12 1 Resolution 800x600 Table 17 4 Environmental Requirements Temperature Ambient pressure Humidity Operation 15 C 35 C 560 1030 hPa 15 95 non condensing Storage 5 C 70 C 500 1060 hPa 95 non con densing Table 17 5 Pneumatic Specifications Supply gas Medical grade air and oxygen Minimum supply pressure 3 5 kg cm2 343...

Page 194: ...tilatory parameters adjustment Parameter Range Increments 1 Initial value Tidal Volume L ADL 0 050 2 500 PED 0 005 0 300 NEO INF 0 005 0 150 ADL 0 010 PED 0 001 NEO INF 0 001 ADL 0 402 2 PED 0 051 2 NEO INF 0 009 2 Minute Volume MMV PSV set ting 4 L min ADL 1 50 PED 1 50 NEO INF N A 0 100 ADL 6 0 PED 4 0 NEO INF N A Controlled pressure PCV cmH2 O PCV PEEP 2 100 1 ADL 15 PED 8 NEO INF 8 Support pre...

Page 195: ... sation in NIV L min Non adjustable N A ADL up to 50 PED up to 30 Leakage com pensation for the rest of the modes L min Non adjustable N A ADL up to 15 PED up to 15 NEO INF up to 10 Tube compen sation Tube Endotracheal or tracheostomy Diameter 4 12 mm Compensate 10 100 N A Tube Endotra cheal Diameter 8 mm Compensate 50 Activated NO 1 An asterisk next to some of the values in this column means that...

Page 196: ... 0 005 1 NEO INF 0 005 1 ADL 0 600 PED 0 075 NEO INF 0 015 Minimum tidal volume 2 L ADL 0 010 to VTmax PED 0 001 to VTmax NEO INF 0 001 to VTmax ADL 0 010 2 PED 0 001 1 NEO INF 0 001 1 ADL 0 150 PED 0 025 NEO INF 0 005 Maximum minute volume expired 4 L min ADL VMmin 55 PED VMmin 55 NEO INF VMmin 55 0 01 0 05 0 1 0 5 1 0 according to the alarm limit value ADL 7 23 9 0 en MMV PSV PED 1 91 6 0 en MMV...

Page 197: ...declared for ADL and PED correspond to the NIV mode For the rest of the modes the Leakage out of range is triggered starting at 15 L min In NEO INF the leakage within range is the same for all modes Table 17 10 Data collection for control and monitoring Parameter Method Involved Variables Accuracy Accuracy Relative pressure transducers Control support and monitored pressures 2 cmH2 O Controlled fl...

Page 198: ...01 1 2 Test level Compliance level Electromagnetic environment IEC 610000 4 4 Electrosta tic Discharge ESD Contact 6 kV Air 8 kV Contact 6 kV Air 8 kV Floors must be wood concrete or ceramic If floors are covered with synthetic material the relative humidity must be at least 30 IEC 61000 4 4 Fast electrical transient in bursts 2 kV for power lines 1 kV for input output lines 2 kV for power lines 1...

Page 199: ...e equipment marked with the following symbol NOTE 1 For 80 MHz and 800 MHz apply the higher frequency range NOTE 2 This guide may not apply to all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 The ISM bands industrial scientific and medical between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MH...

Page 200: ...Hz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 has been incorporated into the formula used for cal culating the separation distance for transmitters operating in the ISM frequency band between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to reduce the possibility that communication equipment mobile and or por table can cause interferen...

Page 201: ...ystem which includes the operating system that controls the microprocessor and various components that act independently of these WATCHDOG this is a system that monitors the operation of the electronic circuit and exerts its control regardless of the integrity of the latter When it detects an anomaly in the ventilator function it allows it to suspend and enables the Emer gency Ventilation mode Wat...

Page 202: ...ssure within the patient circuit reaches a value of 120 5 cmH2 O The gas mixture passes into an internal collector and is discharged to the outside INSPIRATORY RELIEF VALVE ANTI SUFFOCATION this valve allows the pa tient to inspire room air when the unit is energized or when the ventilator is in inoperative status OPERATING GAS LEAKAGE The gas that can seep into the unit is collected in a common m...

Page 203: ...rt its presence For further information on how the alarm system works refer to the chapter Alarms PARAMETER SETTING to prevent inadvertent changes to the parameters it is required to execute the established sequences on the ventilator controls Thus the pressure on a single key or knob does no allow entering changes Therefore the operator is always aware of the actions executed on the unit Fig 17 1...

Page 204: ...alve Inspiratory relief valve anti suffocation Nebulizer optional Outlet Towards Patient Low pressure sensor Expiratory set expiratory valve and pneumotachograph Cycling valve PEEP proportional solenoid valve Table 17 16 Lifetime Ventilator lifetime 10 ten years 17 15 Lifetime 11 8 13 16 10 15 7 12 9 14 6 ...

Page 205: ...Appendices iTernIS ADV A i Appendices Chapter Contents A I Troubleshootings ...

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Page 207: ...ent if any Defective expiratory set or airtightness loss Poorly connected pneu motachograph hoses P1 and P2 Inner membra ne damage of pneumota chograph Partially obs tructed Y connector Check the cap on the Y connector Check connec tions on P1 and P2 Check integrity of the pneumota chograph internal membra ne Solve the failure and execute a new calibration Failed calibration of O2 sensor Sensor ex...

Page 208: ...ted O2 tube or closed re gulator Air compres sor out of service Check all listed items as possible causes Low oxygen or air pressure The possible causes of the preceding event for gas with low supply pressure Follow the suggested recom mendations for the aforementio ned event Dead battery Prolonged internal battery operation Plug the electric power cable to an adequate network distribution If the ...

Page 209: ...y Check that the gas at the AIR in let is compressed air If the gas supply is correct recalibrate the O2 sensor to rule out the option of empty cell for low concentration Otherwise change the sensor Apnea condition Cessation of patient s spontaneous activi ty Very high inspira tory detection Leaks in continuous CPAP waveform NEO INF Check the value of the configured inspiratory detection and corre...

Page 210: ... no breathing detected Apnea condition Dis connected adapter of the sensor or of the patient circuit Dama ged or dirty adapter Check the capnograph adapter connections Clean if the win dows are very dirty CO2 out of range Measured value ex ceeds 150 mm Hg Perform a reset to zero Check the patient adapter Sensor out of the adapter Optical bloc king of the adapter windows Defective reset to zero Che...

Page 211: ...is of technical defects of individual components The warranty obligation can only be recognized by us if the device has been used properly and according to its inten ded use and no repair attempts have been undertaken by the client himself or by third parties The warranty claim does not include faults caused by mechanical damages or if the device is being operated with accessories originating from...

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Page 213: ... patient informaton 7 4 Dynamics and statics calculation 12 4 Compressed air filter 3 4 16 6 Control adjustment 4 3 CPAP 9 6 PSV CPAP 10 4 Continuous flow 10 10 CTesp 7 3 D Date and time adjustment 7 12 Description of ventilator 4 2 E Electromagnetic compatibility 17 6 Electromagnetic emissions 17 6 Electromagnetic immunity 17 6 Emergency ventilation 17 9 Expiratory detection 6 13 9 6 Adjustments ...

Page 214: ...bly 3 3 Physiological VD VT breathing mechanics 12 12 Pimax breathing mechanics 12 10 P0 1 12 7 Programmed inspiratory pause 7 5 PRVC pressure regulated volume controlled 9 15 PSV support pressure 9 5 10 4 With Assured VT 9 11 PVflex inflection points 12 9 R Rear panel 4 11 Reference loops 8 6 Release valve antisuffocation 17 10 resistance 12 3 Rise time 6 13 9 4 9 13 Rotary knob 4 9 S Safety mech...

Page 215: ...Alphabetical index iTernIS ADV I iii W Watchdog 17 9 WOBi 7 3 Y Y connector or part 3 8 ...

Page 216: ...Alphabetical index iTernIS ADV I iv This Page Left Intentionally Blank ...

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