Engstrom Ventilator Technical Reference ManualEngstrém Ventilator Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product, group code, the year of manufacture, and a sequential unit number for identification. The serial ‘number can be in one of two formats. [AKAXI1111 ANAXXLLTIITAA The Xrepresents an alpha character indicating the year the product was manufactured; = 2004, K = 2005, ete. Vand 0 are notused. [The XX represents a number indicating the year the product was manufactured; [04 - 2004, 05 ~ 2005, Engstrém Ventilator, ComWheel, D-fend and EValr 03 are registered trademarks of Datex-Ohmeda inc. Other brand names or product names used in this manual are trademarks or registered ‘trademarks of their respective holders. 10/04 1505.1018.000,Technical Reference Manual Engstrom Ventilator ‘This document is not to be reproduced in any manner, nor are the contents to be disclosed to anyone, without the express authorization ofthe product service department, Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin, $3707. © 2004 Datex-Ohmeda Inc. 1505-1018-000 10/08 iEngstrém Ventilator Important The information contained in this Technical Reference manual pertains only to those models of products which are marketed by Datex-Ohmeda as of the effective date ofthis manual or the latest revision thereot. This Technical Reference manual was prepared for exclusive use by Datex-Ohmeda service personnel in light of their training and experience as well as the availabilty to them of parts, proper tools and test equipment. Consequently, Datex-Ohmeda provides this Technical Reference manual to its customers purely as a business convenience and for the customer's general information only without warranty ofthe results with respect to any application of such information. Furthermore, because of the wide variety of circumstances Under which maintenance and repair activities may be performed and the unique nature of each individual's own experience, capacity, and qualifications, the fact that customer has received such information from Dates-Ohmeda does notimply in anyway that Dates-Ohmeda deems said individual to be qualified to perform any such maintenance orrepairservice. Moreover, itshould not be assumed that every acceptable test and safety procedure or method, precaution, tool, equipment or device is referred to within, othat abnormal or unusual circumstances, may not warrant or suggest diferent or additional procedures or requirements. ‘This manualis subjectto periodic review, update and revision. Customers are cautioned to obtain and consult the latest revision before undertaking any service of the equipment. Comments and suggestions on this manual are invited from our customers. Send your comments and suggestions to the Manager of Technical Communications, Datex-Ohmeda, (Ohmeda Drive, PO Box 7550, Madison, Wisconsin 53707, AXCAUTION Servicing of this product in accordance with this Technical Reference manual should never be undertaken in the absence of proper tools, test equipment and the most recent. revision to this service manual which is clearly and thoroughly understood Technical Competence ‘The procedures described in this Technical Reference manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices ofthis nature. No repairs should ever be undertaken or attempted by anyone not having such qualifications. Datex-Ohmeda strongly recommends using only genuine replacement parts, manufactured or sold by Datex-Ohmeda forall repair parts replacements, Read completely trough each step in every procedute before starting the procedure; any exceptions may result in a failure to properly and safely complete the attempted procedure i 10/04 1905-1018-000,1505-018-000 10/08 Important . Technical Competence . 4.1 Whatthis manual includes 1.2 Users Reference manuals 1.2 Conventions used 1.3 Whatis an Engstrdm Ventlator? 1.4 Ventilatoroverview 1.8 Display controls an indicators 1.6 Ventilator display 1.6.1 Using menus 1.7 Symbols used in the manual or on the equipment Table of Contents 12 12 12 13 14 16 17Engstrém Ventilator 2 Theory of Operation 2.1 Pneumatic Operation 2.1.1 Inspiratory ceuit, 2.1.2 Bxpiratory circuit 2.1.3 Associated cicuts 2.1.4 Eleevoniemieropump nebulizer 2.2 Elecvical Operation 2.2.1 Display Unit (DU) 2.2.2 Communication channels 2.2.3 VentlatorContrl Board-VCB 2.2.4 Ventlator MonitoringBoard-VMB 2.2.5 Power Management Board ~ PMB 2.2.6 Other Electonietems 2.2.7 Motherboard (backplane) 2.2.8 Monitoring Interface Board - Monitoring Module Bays 3 Checkout Procedure 3.1 Inspectthe system . 3.2 Automated Checkout 3.3 Backlighttest 3.4 Powerfallure test... 3,5 Electvical safety tests 4 Installation and Service Menus 4.1 Service and Installation menu structure 4.2 install/Service Menu (Super User) 4.2.1 Defaults 4.2.2 Factory Defauts 43 Calibration menu... 4.4 Service menu 4.4.1 Configuration 4.4.2 Copy Configuration 4.4.3 Senice Logmenu 4.4.4 Sofware/Hardware version menu 2 10/08 22 22 27 28 28 29 29 240 212 2414 216 247 32 32 33 33 33 42 43 44 45 46 AT 48 49 1505-1018.000Table of Contents 5 Service Tests and Calibration 5.1 Calibration (super-user) 52 5.1.1 Calibration procedure 53 5.2 Sewice level tests and calbration 54 5.2.1 Service application setup 5.2.2Testsetup .. we 5.2.3 Ventengine debris clean-out 5.2.4 Vent engine leak test low pressure) 5.2.5 Vent engine leak test (high O, pressure) 5.2.6 Vent engine leak test (high Air pressure) 5.2.7 Calibrate airway pressure transducer Zero and Span 5.2.8 Very operation of ree- breathing valve 5.2.9 Very operation of inspiratory effort valve 5.2.10 Vetfy operation of auxiliary pressure relief valve 5.2.11 Mechanical overpressure valve test 5.20 5.2.12 Verify regulator output pressure. 5.22 6 Maintenance 6.1 Engstrém Ventilator planned maintenance .... we we 62 6.1.1 Every twelve (12) months 2.0... oe we 62 6.1.2 Every forty-eight (48) months. 62 6.2 Battery capacity test 63 7 Troubleshooting 7.1 Troubleshooting Checkout Failures ......-..- we we 12 Tut PawTransducer Cheek .......seese+0 we we 72 7.1.2 Barometric pressure test 72 7.1.3 Low Pressure Leak and Compliance Check 73 7.1.4 Safety Valve Relief and Back Pressure 73 7.1.5 Bahalation Valve Calibration Check... we we 14 7.1.6 Bahalation Flow Sensor Calbration Test we we 7.4 7.1.7 Measute Breathing Circuit Resistance 7.4 7.1.8 Air Inspiratory Flow Sensor Calibration Check 78 7.1.9 0, Inspiratory Flow Sensor Calibration Check 15 7.1.10 0 SensorTestand Calibration ...... we we 75 7.2 Troubleshooting Vent Engine Leaks . 7.3 Alarm message troubleshooting chart 7.4 Troubleshooting Service App messages 726 1505-1018-000 10/08 3Engstrém Ventilator 8 Service Diagnostics and Software Download 9 Repair Procedures 8.1 EVSenice Application 8.1.1 Main Menu and System Information 8.1.2 Power Diagnostics 8.1.3 Power Controller Power Diagnostics, 8.1.4 Display Unit Power Diagnostics 8.2 Display Diagnostics 8.3 Special Functions 8.3.1 View Revision Log 8.3.2 View PC Card Install Log 8.4 Software Download 8.5EVSonice Application PC based) 8.5.1 Port Setup 8.5.2 Main Menu and System Information ... 8,6 VOB Diagnostics and Calibration . .. 8.6.1 Sensirion Sensors 8.6.2,VCB Input Signal Latch 8.6.3 VCB Channel Configurations 8.6.4 VCB Outputs 8.6.5 Calibrations and Tests 8.7 VMB Diagnostics '8.7.1,VMB Channel Configurations 8.7.2. VMB Outputs 8.7.3 VMB Data 8.7.4 Baro P Cal 9.1 Circuit Board Replacement precautions 9.1.1 Software download 9.1.2 Required calibrations 9.2 How to bleed gas pressure from the machine 9.3 Accessing chassis components 9.3.1 To remove the chassis from the housing 9.3.2 To remove the Vent Engine from the chassis 93,3 To replace chassis mounted components, 9.3.4 To replace Vent Engine components -.. 10/08 82 82 83 84 86 87 88 89 89 810 8.12 812 814 818 8.20 8.20 8.20 93 93 93 9-4 9-4 95 95 9-6 96 1805-1018.00010 Illustrated Parts 9.4 Servicing the Display Unit 9.4.1 Remove the Display Unit... 94,2 Disassemble the Display Unit 9.4.3 To replace the CPU board 9.4.4To replace the LOD cisplay 9.4.5To replace the backlghts 9.4.60 replace the Inverters we 9.4.7 To replace the front enclosure or components 9.5 Adjusting the display arm 9.5.1 Adjust upper plvot 9.5.2 Adjust lower pivot 9.5.3 Adjust am bearing 9,6 Removing a compressor from the cart 10.1 Senvice tools 10.1.1 Software tools, 10.1.2 Manual shutoffvalves 10.1.3 Special tools 10.1.4 Leak test devices. 10.1.5 Lubricants and Adhesives . 10.2 Extemal components front view 10.3 Btemal components- rearview 10.4 Display arm mounting hardware 10.5 Display am assembly 10.6 Display Unit 10.7 Main enclosure (extemal) 10.8 Main enclosure (intemal 10.9Vent Engine 10.10 Outer manifold 10.11 Inlet manifold 10.12 AC powercords 10.13 AC nlet/Outet Components 10.14 car, 10.15 Module rack 10.16 Compressor 10.16 Exhalation valve assembly ‘Schematics and Diagrams 1905-018-000, 10/08 Engstrém Ventilator 97 9-7 9-8 10-20 10-22 1023 1024 1026 1028 1029 1030Notes 6 10/04 1905.1018-000,In this section 1505-018-000 10/08 1 Introduction This section provides a general overview of the Engstrém Ventilator. 1.1 Whatthis manual includes 1.2 Users Reference manuals 1.2 Conventions used 1.3 Whatis an Engstrim Ventlator? 1.4 Ventilatoroverview 1.8 Display contols and indicators 1.6 Ventilator display 1.6.1 Using menus 1.7 Symbols used in the manual oron the equipment 12 12 12 13 14 16Engstrém Ventilator 1.1 What this manual includes Other equipment This manual covers the service information forthe Engstrém Ventilator. ttoovers the following components: += Display Unit + Integral electronics += Gas delivery components + Frame component Other equipment may be attached to the system. Consult separate documentation relative to these items for details, 1.2 User’s Reference manuals Conventions used Hard keys Menu selections Sections and headings 12 ‘Some sections of this manual refer you to the User's Reference manual for the Engstrém Ventilator. To expedite repairs, you must have, and be familiar with, the User's Reference manual for this product. Refer to the Engstrém Ventilator User's Reference manual ifyou need further information about the operation of the system. Names of the hard keys on the display and modules are written in bold typeface, for example, Normal Screen. Menu selections are writen in bold italic typeface, for example, Patient Setup. Messages that are displayed on the screen are enclosed in single quotes, for example, ‘Check sample gas out.’ When referring to different sections or headings in the User's Reference manual, the name is written in italic typeface and is enclosed in double quotes, for example, “System Controls and Menus." 10/04 1905-1018-000,Introduction 1.3 What is an Engstrom Ventilator? ‘The Engstrém Ventilator (EV) isa flexible, adaptable, and intuitive critical care ventilator A wide selection of perfomance options gives the user full contral ofthe system configuration ‘The EV must only be operated by authorized medical personnel well trained in the use of this product, for patient ventilation in the intensive care environment. It must be operated according to the instructions inthis User's, Reference manual. ‘The ventitatoris designed to be used with infant through adult patients with a body weight of 5 kg or greater. The EVs designed to maintain lung ventilation in the absence of spontaneous breathing effort as well as in support of the patient's existing spontaneous breathing effort. ‘The system is designed for facility use, including within-faclity transport. ‘The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator Optional accessories include an air compressor, airway modules, module bay, humidifier and water rap mounting brackets, and auxiliary electrical outlets. Figure 1-1 + Engstrom Ventilator (EV) 1905-1018-000 10/08 13Engstrém Ventilator 1.4 Ventilator overview Nebulizer connection Exhalation valve housing 10, Expiratoryinlet 11. Expratory low sensor 12, Gas exhaust por 13, Leaktest plug 14, Exhalation valve housing atch 15. Watertrap 16. Auxiliary pressure port 17. Inspiratory outlet 1, Module bay (optional 2, Ventilator lock [locks Ventilator unit (tem 6) to Cart (item 3)] 3. Cart 4. Caster 5. Dovetail ails 6. Ventilator unit 7. Display 8 8 Figure 1-2 » Frontview of the EV 7 8 910 112 16 15 14 10/04 1905-1018-000,15 14 2B 12 a 10 Display fan fitor Display connection Module bay connection AC mains inlet System switch Equipotential connector (Oxygen supply connection (aipeline) Air supply connection (pipeline or compressor) Module bay mounting thumbscrews 10. Ventilator unitfanflter 11, Serial communication por (RS 232 port) 12. Am holder 13 RS 485 port (not curently supported) 14. RS 485 pot (not curently supported) 15, RS 422 por (used to communicate with PC based Service Application — Referto Section 8.5) 16. Network ID connection 17. Etheret connection 18. DIS port (not currently supported) 19, USB port Figure 1-3 * Back view of the EV 1505-018-000 10/08 introduction 15Engstrém Ventilator 1.5 Display controls and indicators 8 Alarm LEDs Alarm Silence key Menu keys, ComWheel Normal Sereen key ACmains indicator Quick keys 100% 02 key The red and yellow LEDs indicate the priority of actve alarms. Push to silence any active, slenceable high and medium priority alarms oF to suspend any non-active medium priority alarms. Alarm audios silenced orsuspended for 120 seconds, Push to clear resolved alarms, Push to show corresponding menu Push to select a menu item or confirm a setting, Turn clockwise or counterclockwise to scrall menu items or change settings. Push to remove all menus from the screen, ‘The green LED lights continuously when the EVs connected to an AC mains source, The intemal batteries are charging when the LED ist Push to change corresponding ventilator setting. Tum the ComWhee! to make a change. Push the Quick ey or ComWheel to activate the change, Push to deliver 100% 0, for 2 minutes. Figure 1-4 * Controls and indicators 16 10/04 1905-1018-000,Introduction 1.6 Ventilator display 1 ase cay Kot AAA A ry Wi PVT w UU CII =e 498 60 Bes a 100 500 | 18 | 1:2 | Xxx | Xxx | 28 18 1 Alarmsilence symbol and countdown 2 Alarm message fields 3 Waveform fields General message field Clock Measured value fields Digitfietd Ventilator settings Displays the time remaining during an alarm silence or alarm suspend period. ‘Alarms will appear in order of priaity. Refer to “Alarms and Troubleshooting” for more information on alarm behavior. The top two waveforms are permanently set to Paw and Flow. The tird waveform may be selectec a8 C0, Op, Vol, Pau, or Off. Displays informational messages. ‘The time may be set in 12 of 24 hour format inthe Time and Date menu. Displays current measured values corresponding tothe waveforms. Displays information elated to Volume, CO, Op, Compliance of Sptometry Displays several ofthe settings fr the current mode of ventilation. Figure 1-5 * Normal Screen view 1905-018-000 10/08 1Engstrém Ventilator ‘When a menu keys selected the waveform fields start at the right edge of the menu. The entire waveform is always displayed 2 5.1 ase)" | m —_ W000 X00 we a =: (A/UWU 7 = yay nti 8 2 5 498 60 i m wUUL 1.2 Xxx Xxx faverio0 28 miDO/ne 18 1, Menu 2, Waveform flelds Figure 1-6 * Menu view 10/04, 1905.1018-000,1.6.1 Using menus 1905-018-000 10/08 Introduction Push a menu key to display tne corresponding menu. Use the ComWheel to navigate through the menu. A, Yoon X00 en eect Tes no Tne Xen Xena exo saga enc roa Tr Koa 1. Menuttle 2, Present selection 3, Adjustment window 4, Indicates submenu 5, Shortinstrctions & Menu selections Figure 1-7 * Example menu 1. Push the menu key to display the corresponding menu, 2, Turn the ComWheel counterclockwise to highlight the next menu item. (Tum the ComWheel clockwise to highlight the previous menu item.) 3. Push the ComWheel to enter the adjustment window or a submenu. 4, Turn the ComWheel clockwise or counterclockwise to highlight the desired selection, 5, Push the ComWheel to confirm the selection, 6. Select Normal Screen or push the Normal Screen key to exit the menu and retum to the normal monitoring display. (Select Previous Menu to retum to the last displayed menu, if available.) 19Engstrém Ventilator 1.7 Symbols used in the manual or on the equipment |\2>CGCO- Sith ect 140 ‘Symbols replace words on the equipment, on the display, orin Datex-Ohmeda manuals. ‘Warnings and Cautions tell about the dangerous conditions that can occurif the instructions in the manual are not followed. Warnings tell about a condition that can cause injury to the operator or the patient. Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions, On (power) Off (power) On for part ofthe equipment. Off for part of the equipment. Standoy Type B protection against electrical shock Attention, refer to product instructions Caution, ISO 7000-0434 lec 60601-1 Stock number Serial number Direct current Alternating current Earth ground Protective earth ground Equipotential connector Fuse Lock Unlock Variability Variability n steps Plus, positive polarity Minus, negative polarity Movement in one direction Movementiin both directions This way up Warning, dangerous voltage Pl 'h®yO2epro0 10/04, 1905.1018-000,1 Paux & Pneumatic inlet Electrical input Inspiratory port Electrical testing certification Serial port Module bay port Auxiliary pressure port No battery/ battery failure Silence alarms Hourmeter 1505-018-000 10/08 {4 EXP, €: Ss § Q € introduction Pneumatic outlet Electrical output Expiratory port Inspiratory breath identifier Module data indicator Electronic micropump nebulizer Display signal input/output Battery in use. Bar indicates amount of battery power remaining. Submenu Drain outlet tatEngstrém Ventilator Air AIR % Heavy object a A Ethemet connection 134°C —Autoclavable Authorized representative in the European Community ss Y > fe cé Pump USB port Network ID connection (Datex-Ohmeda proprietary port) Not autoclavable Systems with this mark agree with the European Council Directive (83/42/EEC) for Medical Devices when they are used as specified in their User’s Reference Manuals, Theos the certification number of the Notified Body used by Datex-Ohmeda’s Quality Systems. 10/04 1905.1018-000,2 Theory of Operation In this section 2.1 Pneumatic Operation 22 2.1.1 Inspiratory circuit 2.1.2 Bppiratory circuit 2.1.3 Associated circuits 2.1.4 Electronic micropump nebulizer 2.2 Electrical Operation 2.2.1 Display Unit(DU) 2.2.2 Communication channels 2.2.3 Ventilator Control Board- VCB 2.2.4 Ventilator Monitoring Board - VB 2.2.5 Power Management Board - PMB 2.2.6 Other Electronic tems 2.2.7 Motherboard (backplane) 2.2.8 Monitoring Interface Board - Monitoring Module Bays 1505-018-000 10/08 2Engstrém Ventilator 2.1 Pneumatic Opera‘ 22 2.1.1 Inspiratory circuit Fora complete diagram of the pneumatic system, refer to Figure 11-2, "Vent Engine manifold flow diagram" in Section. ‘The EV requires a medical-grade oxygen (0) and Air source ranging from 2.4 t0 6.5 bar (35 to 94 psi). ‘The system includes two separate channels (0, and Ait) to provide dynamic. mixture control of the delivered 0 percentage. ‘The Air supply may include an optional compressor unit(1) for applications where pipeline Airs not available orto provide a continued Air supply ifthe pipeline supply goes down. a Compressed gas enters the EV through an inlet fitting (2) that is particular to the institution's supply system. The gas is fitered through a 2-micron particulate filter (3) as it enters the ventilator’s “pneumatic engine” manifold high-pressure transducer (4) having a dynamic range of Oto 8.3 bar (Oto 120 psi)is tapped at the outlet ofthe filter. This transducer monitors the adequacy of the supply pressure. Failures of supply gas, coupling hoses or an ‘occluded filter are identified by the supply pressure transducer, @ 10/04 1905-1018-000,1805-018-000 10/08 2 Theory of Operation Next in the downstream path of flow is a check valve {5}. The check valve prevents backflow from the EV that would possibly contaminate the supply pressure lines. For example; if the 0, supply were to be lost, the check valve in the O, channel will prevent Air from moving back into the O supply ines, @ Downstream from the check valve is a 172 kPa (25 psi) pressure regulator(6}. (The regulator is a non-relieving type that does not bleed gas into the ventilator’s enclosure.) The regulator ensures a constant pressure supply to the flow valve {8}. The regulated supply is flow rate dependant, which is ‘compensated for in the flow valve's on-site calibration. Between the regulator and the flow valves is the inspiratory flow sensor {7}. The sensoris a thermal mass-flow type that injects heat into the low stream ‘and monitors the associated temperature rise at a downstream location. The temperature change is dependent on the mass flow ofthe flow stream and the specific heat ofthe gas moving through the sensor. Since the composition ‘of gasin the sensor is known, a conversion of mass-flow rate to volumetric flow at ambient conditions can be made using the ambient density ofthe gas. ‘The sensor uses a laminar (two channel) flow element to spit a portion ofthe flow through the sensor past the heat injection and temperature sensing. elements. The sensors pre-calibrated and includes an electronic PCB that produces direct digital output of mass flow through an RS-232 interface. Individual flow sensors measure the volume of gas dispensed from the 0, and AAirchannels during inspiration and expiration. The relative proportion of gas dispensed from each channel s continuously adjusted to precisely control the percentage of 0, delivered tothe patient 23Engstrém Ventilator Downstream of the flow sensors a flow valve (8) that meters flows from approximately 0.05 I/min (leakage level to a full flow value of 160 /min. The valve is a normally- closed proportional solenoid that is powered by a current feedback loop. When calibrated on-site, using data from the inspiratory flow sensor, a precise volumetric flow versus input current profile is developed that. includes both the valve and regulator characteristics. Following the two individual low valves is the total flow sensor {10}. This sensoris the same type as the individual low sensors andis used to measure the combined inspiratory flow being dispensed from the system. Using the known mixture composition along with atmospheric pressure and gas temperature information, mass-flow data from the sensoris converted to delivered volumetric flow towards the patient. During calibration, the sensoris checked against the output of the O and Airflow sensors to ensure proper operation, 10/04 1905-1018-000,1905-018-000 10/08 2 Theory of Operation Following the total low sensor are the free-breathing check valve (11) and the inspiratory effort valve (12). During normal operation, the inspiratory effort valve is open, allowing the free-breathing check valve to admit flow ifthe patient draws a significant amount of inspiratory pressure, causing the airway pressure to become more negative than -0.5 cm HO. The fee-breathing check valve allows the patient to spontaneously breathe in case ofa ventilation delivery failure, On occasion, to assess the patient's tolerance to be weaned from the Ventilator, clinicians can determine the amplitude of inspiratory effort thatthe patient can create. During this “procedure”, the inspiratory effort valve is. closed, effectively locking out the free breathing valve from the patient circuit. Next inthe flow path is the 0, sensor {13}. The sensoris used to monitor the 0, concentration produced by the combined 0 and Air flows. ‘The 0, sensor uses the paramagnetic principle (oxygen molecules are attracted in magnetic fields) to measure the oxygen concentration, The sensor includes two nitroger-filled glass spheres mounted on a suspension containing a conductive coil that is located in a non-uniform magnetic fel. When the system is disturbed by an impulse of current, the suspension begins to oscillate, inducing an EMF into the coil. The oscilation period of the induced EMF is dependent on the partial pressure of oxygen surrounding the suspension. ‘As sample gas fils the sensor, oxygen thats presentin the sample is attracted into the strongest part ofthe magnetic field. This congregation of 0. molecules alters the natural oscillation frequency of the suspension, Calculations based on the difference between the oscillation period for an ‘oxygen sample and that for nitrogen, and readings from the absolute pressure transducer, determine the measured 0, percentage. 25Engstrém Ventilator 26 Asa safety measure, a relief valve (14), located downstream from the Op sensor, can be energized to vent the fll flow rte ofthe inspiratory delivery side of the system. If an overpressure condition is detected, the valve can be ‘opened by either of the EV's two control processors. To provide redundant safety (independent of the electronic circuits), the valve begins to mechanically relieve pressure at a nominal 115 cm H0. ‘The inspiratory airway pressure transducer (15), along with its associated zeroing valve, is located just prior to the inspiratory outlet port. This transducer has a range of -20 to 120 om H20 and serves as one of three airway pressure measuring devices in the EV. 10/04 1905.1018-000,2 Theory of Operation 2.4.2 Expiratory clrouit atthe expiratory side of the ventilator, a solenoid powered exhalation valve {16} controls exhaust from the breathing circuit. The valve contains an elastomer diaphragm thatis held agains a rigid seatby solenoid (voice coi) driven piston. The valve achieves a balance between the pressure generated within its 21-mm diameter seat area and the force applied by the piston, releasing exhalation flow as necessary to maintain balance. The proportional solenoid controls the exhalation sealing pressure within a range of 0 to 100 em HO. Software conta provides continuous oscillatory movement (dithering) ofthe exhalation valve to minimize static tition effects Immediately upstream of the exhalation valve is a tap for the expiratory pressure transducer {17} and its associated zeroing valve. The expiratory pressure tap is continuously purged with 35 m/min of airto ensure that exhaled condensate does not occlude the tap. The airflow is established from the regulated Airsupaly using a fixed orifice (pneumatic resistor) {18}. Downstreatn of the exhalation valve is the expiratory flow transducer(19}. In principle, the transducer is similarto a hot-wire anemometer. A wire having a large “temperature to electrical resistance” relationship is placed in the flowstream. The wire is kept at a constant temperature using a Wheatstone bridge circuit, The current necessary to maintain the resistance of the sensor portion ofthe bridge isa function ofthe flow through the sensor tthe output of the flow sensoris a flapper type check valve {20} that prevents gas from being drawn in trough the expiratory valve and minimizes patient rebreathing inthe event of a ventilator failure 1905-018-000 10/08 2Engstrém Ventilator 2.1.3 Associated circuits Associated with the inspiratory and expiratory pressure transclucers are two “zeroing” solenoid valves (21) and {22}. These valves are used to disconnect the pressure transducers from circuit pressure and vent them to atmosphere during zero bias calibration, This zeroing procedure is conducted routinely (every 12 hours) under the control of the Vent Engine software, 28 2.1.4 Electroni micropump nebul er third (auxiiary) pressure channel (23)is used to measure additional patient “airway" pressures at the discretion of the clinician. This port could be used measure circuit pressure directly atthe airway, laryngeal cutf pressures or pressures lower in the airway tract. The transducer circultincludes a valve (24) to provide a 35 ml/min purge flow as required by the particular clinical application, For example, in measuring airway pressure at the endotracheal tube the purge would mostlikely be turned on, but for measuring laryngeal cuff pressures (closed system) the purge would be turned off. The purge flow is established from the regulated Air supply using a fixed orifice (pneumatic, resistor) (25). The relie valve (26) limits pressure inthe auxiliary channel to less than 230 om H0. The Aeroneb Professional Nebulizer System (Aeroneb Pro) by Aerogen, Inc. {27)is integrated into the EV. This nebulizeris electrically connected to the EV and uses proprietary technology to produce a fine-droplet, low-velocity aerosolized drug delivered into the breathing circuit ‘The Aeroneb Pro is designed to operate in-line with standard ventilator circuits and mechanical ventilators. t operates without changing the patient ventilator parameters. 10/04 1905-1018-000,2 Theory of Operation 2.2.4 Display Unit (DU) Fora complete diagram of the electrical system, refer to Figure 11-4, "Electrical architecture” in Section 11. ‘The EV includes 4 major processor control boards: «= the Display Unit (DU), * the Ventilator Control Board (VCB), ‘the Ventilation Monitoring Board (VMB), ‘= and the Power Management Board (PMB). ‘Two analog boards — the motherboard (backplane) and the monitoring module power supply board —round out the electronic architecture. ‘The DUis physically separate trom the ventilator chassis (connected through a single cable running through the display arm). The DU contains a CPU board based on the Elan $C520 processor. Asmall daughter board (DU Interface board), provides a communications interface (2}+ between the DU's CPU and the remainder ofthe EV system. A second daughter board (DU Connector board), provides hardware connector interfaces forthe USB # , Network 1D 2, Ethemet{{ , and DIS (Display interface Solution) ports ‘The CPU board includes a PCMCIA (PC Card) interface, ‘The DU’s CPU board provides power and signals for operating the main audio speaker and a 12 inch (30 cm) packltcolor LCD display, providing an interactive video interface. Membrane keys from three front-panel keypads and a rotary encoder (ComWheel) complete the loop for acquiring user inputs. ‘The DU housing contains a continuously operating tan for temperature reduction. Ld Display Unit 1505-018-000 10/08 i ? by “sour” || oveamse t 29Engstrém Ventilator 2.2.2 Communication channels 2.0 ‘The DU communicates (3 to the remainder of the EV system through the motherboard using § digital channels. [1] A500 Kbaud, RS-485 interface (Mod Bus: Datex-Ohmeda proprietary module communication protocol), o external monitoring modules This lnk runs through the Monitoring Module Power supply board which forms the physical interface tothe M-Gas (and ultimately other) monitoring modules. ‘Adaitionally, the Mod Bus interfaces with the PSM (Patient Side Module) ‘support circuitry future expansion). [2] 438.4 Kbaud, RS-422 interface relays setting and alarm annur information from the VMB, and receives alarm commands and data. ion [3] A38.4 Kbaud, RS-422 interface relays setting and alarm annunciation information from the VCB, and receives sensor data for presentation to the user as well as alarm commands. As described later, the VMB also communicates directly to the VCB, thus there exists a triangle of bi- directional communication paths between the DU, VCB and VMB. [4] An RS-232 Serial port that routes to an extemal connector directly on the ‘motherboard. Ths link ports data from the DU to other compatible equipment via the Ohmeda Com 1 protocol [5] 438.4 Kbaud, RS-232 link to the PMB. Aside from providing battery and power information to the DU, ths links used to confirm a *hard” power clown of the EV with user inputs to the DU being relayed to the PMB for power down action. 10/04 1905-1018-000,2 Theory of Operation Dray Ut Ds pu-uPL ‘Mod Bus, R485, l 0 convo ‘Are Cobre Module Bay EV Chassis om | Dh. Fae —__asaes [7 vee ent Mar 2G sans Bil artsat] Voce! Astaness sete ‘paca gas a eae g| Se ‘al (41 i 1905-018-000 10/08 sana sox (5) patEngstrém Ventilator Fer} 2.2.3 Ventilator Control Board - vcB ‘The VCB is a Motorola Colafire V4 CPU powered assembly that: + collects information from all EV system sensors (some indirectly from the VMB), + and conto al actuators necessary to effect ventilation delivery ‘The VCB computes and supplies all ventilation sensor monitoring data for display on the DU. If there are alarms to be generated based on this monitoring data, the VCB notifies the DU to post the appropriate alarm message and audio sequence. The VCB ‘observes the DU's response to ensure that the alarm is adequately presented. ‘To control ventilation, the VCB accepts ventilation parameters from the DU. Measured data (waveform and numeric) is also sentto the DU from the VCB. This data flow occurs ‘on the 38.4 Kbaud, RS-422 communications link (VCB - DU Data /0). ‘The VCB also communicates directly with the VMB every 1 ms, receiving expiratory flow, expiratory pressure and 0, sensor data on the 921.6 Kbaud, RS~422 interface (VMB ‘Sensor Data |/0). Barometric pressure data is also received from the VMB, but ata lower data rate. ‘The following sensor information is acquired directly by the VCB: + Air Flow/Temp sensor through the RS-232 cable interface @ 200 He, + 02 Flow/Temp sensor through the RS-232 cable interface @ 200 Hz, + Total Flow/Temp sensor through the RS-232 cable interface @ 200 Hz, * Inspiratory Pressure sensor va a differential analog signal - 12 bits @ 1000 Hz. + Auiliany Pressure sensor via a differential analog signal - 12 bits @ 1000 Hz. ‘Tne VCB contains actuator drive circuits for the following: + the Airand 02 Flow VaWves, + the Exhalation Valve, + the Inspiratory Pressure Sensorzeroing valve + and the Auxiliary Pressure Sensor purge flow valve Allvalve actuators are driven using current drive circuits and feedback controlled using current sense resistors, The VCB contains digital control signals for activating the inspiratory effort and safety relief valves (rough the VMB) and the Piezo-Electric Nebulizer. ‘The VOB receives 12.5 Vdc from the PMB, which it regulates down to various voltages for use by the board's digital circuits and analog drivers. These voltage levels are self- tested on the VCB. An addtional 12.5 Vee power ine is separately connected to an auxiliary buzzeron the \VCB that provides a backup audio alarm source. The buzzeris normally on and must be kept silent by both the VCB and through a dedicated digital ine coming rom the VM. Aresetor failure of ether the VCB or VMB is regarded as a system fault and the buzzer is activated, ‘Tne VCB includes 1 MB of SRAM and 8 MB of Flash memory, The CPU is connected to a digital watchdog circuit to monitor continuous and properly sequenced execution of software code. As the core processor unit for the EV, the VCB includes two external serial I/O channels: one 19.2 Kbaud RS~422 channel (Expansion Port /0 #1 to Extemal Connector 3) and ‘one 500 Kbaud RS-485 channel (Expansion Port I/O #2 to External Connector 2). 10/04 1905-1018-000,2 Theory of Operati ion Forfurther details, refer to Figure 11-9, "VCB block diagram” in Section 11 vos ont Control [a] Board V checks SRAM Coldive Plezolectie TAT Nebulzer veceu | Neb Boars ME || watchdog ir wate Exhal Valve Flow Valve Drive w/ V8 \VMB Sensor oy OF « Data VO. Flow Vale Expansion Por WOR Tir valve Dive Expansion Por UO #2 wl Senge Insp Effet Vale (2 Valye Drive [Jexratvaiee ‘wil Sense Salty eh ONO Exh Valve On1OF BaD Power for Buzzer a a BUARTS: Sonal XCVRS Backup ‘Currant int Control Backup Expansion Signale 018-000 10/08 ARP Purge ValveEngstrém Ventilator 2a 2.2.4 Ventilator Monitoring Board - VMB ‘The VMB is based on an Atmel Atmega 128 CPU. The VMB performs as an independent monitoring system that provides computational and oversight redundancy to the DU and VeB. ‘The VMB independently acquires sensor data relatingto the ventlator’s three safety parameters: * airway pressure (expiratory), += delivered 0, percentage, + and exhaled minute/tidal volume, In addition, the VMB monitors the air and oxygen supply pressures: *« Air High Pressure Supply via analog cable ~10 bits @ 11 Hz, + 02 High Pressure Supply via analog cable - 10 bits @ 11 Hz, + Expiratory flow sensor data via an C cable interface @ 200 Hz, + 0, Concentration via a serial cable @ 5 Hz, + Expiratory Airway Pressure via analog signal - 12 bits @ 1000 Hz, + Barometric Pressure onboard VMB - 10 bits @ 11 Hz ‘The VMB controls safety valve actuator that enables itto unilaterally relieve pressure inthe breathing circuit. Ths allows the barotrauma hazard with its '50 ms reaction time to be independently controlled by either action of the CB or VMB. The hazards associated with 0, concentration (improper mixture) and low exhaled minute volume (hypoventilation) have much slower reaction times (on the order of minutes) and are controlled under fault conditions by the VMB's ability to unilaterally activate the backup buzzer ‘The VMB receives 12.5 Ve from the PMB, which it regulates down to various voltages for use by the board's digital circuits and analog drivers. These Voltage levels are self-tested on the VMB. ‘The VMB communicates directly to the DU via the bi-directional 38.4 Kbaud RS-422 channel (VCD - DU Data /0). A separate 921.6 Kb RS-422 link (VMB ‘Sensor Data |/0) is used to transmit the VMB's sensor data to the VCB. 10/04 1905-1018-000,2 Theory of Operation Forfurther details, refer to Figure 11-8, "VMB block diagram” in Section11 ve Vent Mentor Board Thsp Eton Circuit Power ama) [Psp Manenver eae ‘Valve Drive ‘Atmegat28 — Insp Etfor Vale Control eee Say xn Vale Closed Satay ave = Drive ‘Ar Pipatine P ARTS Safety Valo On/Ofh Ex Valve OnOF 02 Pipeline P RS-422__ VMB - DU Data 10, 126 fT ExeFiow | [] Se Flow [\ExpFiow 38.4 Kb Sensor 8d tnfe bs [Sensor 5-422 VMB Sonsor Data UO, 218 Ko Buzzer Control ssf) Gaseme) fuzzer Sense cruit Power Exp P Zero ‘Valve Expansion Signals 018-000 10/08Engstrém Ventilator 2.2.5 Power The PMB isbased on an Atmel Atmega 128 CPU. The PMB performs pawer Management Board - selection between power sources inthe following order: PMB * ACpowermains, + External battery, + Internal battery. ‘The PMB regulates the 24 Vdc power supply output down to raw 16 Vand 12.5 \V power rails that are used throughout the system (al boards locally regulate from these power rails). ‘The PMB controls the charging operation of the internal battery, selecting trickle, bulk, orfloat charge status ‘The PMB communicates with the DU through the 9.6 Kbaud, RS-232 link (PMB Data /0).Itsends status commands to the DU conceming the charge status of the internal 24 V battery ‘The PMB uses this link as a communication interlock to handle the unit shutdown sequence. Once a sighal s received by the PMB from the mechanical On/Standby switch, the PMB prompts the DU for a confirmation signal that shutdown is appropriate (units notin a ventilation therapy state) Once the DU relays this confirmation to the PMB, the power-off sequence is initiated ‘The PMB supports the operation of the EV chassis fan and the fan on the PMB. heatsink. 2.2.6 Other Electronic The EV/5 employs a separate AC to DC switching power supply forthe Items providing nominal 24v voltage level to the PMB. The power supply is capable of regulating 150 W of power output, A power entry module contains fuses and fiers for Mains AC input cables, Finally, two internal 12v batteries are connected in series to provide an internal backup 24v power source for the system, Forfurther details, refer to Figure 11-7, "PMB block diagram” in Section 11 i= — 1 Sea == po Sa ||| | aca” mae = 216 10/04 1905-1018-000,2.2.7 Motherboard (backplane) 1 2 3 4 G Dy 2.2.8 Monitoring Interface Board - Monitoring Module Bays 2 Theory of Operation ‘The EV motherboard provides backplane connectivity forthe VCB, VMB and PMB assemblies in the EV chassis. ‘Analog circuits on the board provide current limiting for external peripheral connections to ensure that the EV's primary ventilation and monitoring functions are not compromised by excessive power draw. In adaition, 10VA energy limit circuitry is provided for power connections within 20 om of O2 exhaust outlets, in order to mitigate the risk of an oxygen enriched fire, ‘The board features 6 external connectors that ext through a rear sheet metal interface: ‘= Patient Side Module (PSM) support connector (future expansion) ‘+ RS-485 Serial (future expansion) connector ‘+ RS-422 Serial (future expansion) connector ‘+ Extemal Serial I/O connector ‘= Main DU connector (communication channel between DU and EV) + Monitoring Module, Mod Bus connector ‘The EV accommodates an optional four-bay module assembly that supports, compatible Datex-Ohmeda M-series modules, ‘The assembly includes a Monitoring interface Board (MIB) that communicates With the DU through the Mod Bus connector, The MIB includes circuitry that regulates the raw16 V power down to +15 V (unregulated), =15 V (regulated), and +5 V levels required by the M series monitoring modules. vo Pana Connectors ¥ tera 1905-018-000 10/08 | | Passer] : i ' ¢ ' Expansion Port U0 #2 : jf j4_fssesenbottoet : : —— | ea to ' 1 | oh + [g[ fers ae : poe : ia a ' ' i¢[ noms a (Se |. eaNotes 218 10/04 1905-1018-000,3 Checkout Procedure Inthis section 3.1 nspecttne system . coeteeeeeee oe we 32 3.2 Automated Checkout ceseteeee we we 32 3.3 Backlighttest ...... cote oe we 33 3.4 Powerfallure test... ceseteeee we we 33 3,5 Electical safety tests cote oe we 33 AX WARNINGS After any repair or service of the Engstrém Ventilator, complete all tests in this section, Before you do the tests in this section: = Complete all necessary calibrations and subassembly tests. Refer to the individual procedures for a list of necessary calibrations. = Completely reassemble the system. Ifa test failure occurs, make appropriate repairs and test for correct operation 1505-1018-000 10/08Engstrém Ventilator 3.1 Inspect the system Before testing the system, ensure that: ‘+ The equipmentis not damaged. ‘+ Components are correctly attached. ‘+ Pipeline gas supplies are connected. ‘+ The casters are not loose and the brakes are set and prevent movement. ‘+ The power cord is connected to a wall outlet. The mains indicator comes, ‘on when AC Power is connected 3.2 Automated Checkout ‘The EV is equipped with an automated checkout. When in Standby, the Patient Setup menu is displayed on the normal screen. 1. Select Checkout. 2, Attach the patient circuit. 3. Occlude the patient wye 4, Select Start Check. ‘+ The results appear next to each check as they are completed, When the entire checkoutis finished ‘Checkout complete’ will appear and the highlight will move to Delete Trends. ‘+ fone or more checks fal, select Check Help for troubleshooting tips. 5. Select Previous Menu. Checkoutincludes the following checks: = PawTransducer Check ‘+ Barometric Pressure Check = Relief Valve Check ‘+ Exhalation Valve Check ‘= Expiratory Flow Sensor Check ‘+ Air Flow Sensor Check + 02 Flow Sensor Check ‘+ 02 Concentration Sensor Check + Circuit Leak, Compliance, and Resistance Note If any ofthe Checks fail, referto Section 7.1, “Troubleshooting Checkout Failures”, to troubleshoot a specific failure. 32 10/04 1905-1018-000,3.3 Backlight test 3.4 Power failure test 3 Checkout Procedure 1. Access the Calibration menu. + Inthe standby mode, push the System Setup key. + Ontthe System Setup menu, select Install/Service (23-17-21). + Onthe Instal/Service menu, select Calibration. 2. Onthe Calibration menu, select Backlight Test. 3, Select Start Test. 4, The display wll show the test running on ight 1 and then on light 2. Ifthe display goes completely blank or flickers during the test, one ofthe lights has failed. 1, Connect the power cord to a wall outlet. The mains indicator on the front panel ofthe Display Unit comes on when AC Powers connected. Set the system switch to On and Starta case. Unplug the power cord with the system tuned on, Make sure that the power failure alarm comes an. Make sure te following message is displayed + On battery’ 6, Connect the power cable again. 7. Make sure the alarm cancels. 3.5 Electrical safety tests 1905-018-000 10/08 AX WARNING Make sure the system is completely assembled and that the power cords are connected as illustrated in Section 10,12. Make sure all accessory devices are connected to electrical outlets. 1. Connectan approved test device (forexample: UL, CSA, or AMI) and verity that the leakage currents less than: Voltage Max. Leakage Current 120/100 Vac 300 pAmps: 220/280 Vac 500 Amps 2. Make sure thatthe resistance to ground is less than 0.22 between the equipotential stud and the ground pin on the power cord. 33Notes 34 10/04 1905-1018-000,4 Installation and Service Menus Inthis section 4,1 Sewice and Installation menu structure 42 4,2 Install/Service Menu (Super User) 43 4.2.1 Defaults aa 4.2.2 Factory Defaults 45 4,3 Calibration menu 46 4.4 Service menu ar 4.4.1 Configuration 48 4.4.2 Copy Configuration 49 4.4.3 Senice Logmenu 410 4.4.4 Sofware/Hardware version menu 1505-018-000 10/08 aEngstrém Ventilator 4.1 Service and Installation menu structure This section describes the Service level functions that are part of the main software installed in the ventilator. Section 8, “Service Diagnostics and Software Download," covers a separate service application that loads from a PCMCIA card and is used to download system software and run service diagnostics and other service tests. Menu structure The Service menu structure has two levels which are password protected * Install/Service (super-user) * Service ‘The Install/Service level (with super-user password) supports standard hospital preferences such as colors, units ventilator settings and alarm defaults, and access to the Calibration and Service menus. The Service level (with service password) supports system configuration and provides access to the Service Log menu. Follow the menu structure to access the various service screens: + on the front panelof the Display Unit, press the System Setup key to access the System Setup menu + on the System Setup menu, select Install/Service to access (with super- user password) the Insall/Senvice menu; ~ select Calibration to access the Calibration menu ~ select Service to access (with sewice password) the Service menus. System Setup Install/Service Callbration ‘Service ‘Sewvice Log Screen Setup Colors o2Fov ‘Configuration Sora Recent Patient Setup Unis irk Parameters Setup | | Snow AlarmLimits | | Exhalation ae Error og System Status Time and Date BacklehtTest copy Contig Event Log Instal/Service —-| Gas Calibration Service Log —bp| Normal Sreen Defaults Cal Flag Bit Alarm Log Calibration ——-»| ‘SWHW versions: Previous Menu Copy Logs Sees. Reset Logs ait > Previous Menu a2 10/04 19064.2 Install/Service Menu (Super User) 4 Installation and Service Menus Use the superuser password to access the Install/Service menu: 23-17-21". ‘Menuitem | Message text Comments Colors | Set colors of parameters. Change color of waveform, digits, and tend for Paw, Flow, 02, C02, Volume, and Pau. (eliow, White, Green, Red, and Blue) Units | Set units of Paw, flow, CO2, height, | Paw —kPa, hPa, cmH20, mmHg, mbar weight, and gas supply pressure. em (Tum poweroffto exit menu) Flow —/min, I/s 602 —%, KPa, mmHg Height — cm, ft Weight — kg, Io Gas Supply Pressure — psi, kPa, bar ‘Show Alarm Limits Select Yes to shaw alarm limits in digit fields, Defauitis Yes Time and Date Change clack and calendar functions, Defaults | Set or change default settings. Referto section 4.2.1, Calibration | Calibrate airway gas and test Referto section 4.3, backlight, Service | Show technical data for Referto section 4.4 troubleshooting and calibration. Exit | Turn power offto ext menu. 1805-018-000 10/08 43Engstrém Ventilator 4.2.1 Defaults Menultem Message text ‘Comments ‘Scroll Settings Push ComWhee! to scroll defautt settings. Defautt Type Select default patient ype. The selected type (Adult or Pediatric) dotermines the Patient Type in the Patient Setup Menu on power up. The corresponding Adult or Pediatric facility defaults are displayed forthe setings on power up. Ifthe setingis changed within ‘a power cycle, those settings remain for a specific Patient Type until they are changed by the user or the venti tumed of View Not selectable: Heading forthe following ‘mutually exclusive lists ~ Adul, Pediatric, Factory, ‘Adult ‘Shaw Adult defaults and settings. ‘The “Adult Settings" page contains a list of parameters or settings and the corresponding “Saved” and “Current” values for the Adult patent type. The "Current values reflect te settings inthe Vent Setup and Alarms Setup menus. Any setting that does not have a value shows three dashes, Pediatrie ‘Show Pediatric detaults and settings. ‘The "Pedlatic Settings” page contains a lstof parameters orsettings and the corresponding “Saved” and “Current” values forthe Pediatric patient ype. The "Current values reflect settings inthe Vent Setup and Alarms Setup menus. Any setting that does not have a value shows three dashes, Factory ‘Show Factory defaults Reterto section 4.2.2 Backup Set defaults for backup ventilation. Save Current, Save current settings as facliy defaults. ‘The default selection is No. Common values in the saved defaults are ‘overridden it another ventilation mode is setup and saved. Save Factory Save factory settings as facility defauts, ‘The default selection is No. ies is selected, “Reset machine for defaults to take effect” Provious Menu Return to previous menu. 10/04 1905.1018-000,4.2.2 Factory Defaults 4 Installation and Service Menus The following table lists the factory defaults for parameters and alarm limits: Setting ‘Adult Pedlatite Backup Defaults Vent Mode Bibevel BiLevel Pov FIO2 30 50 Current FO2 setting W 500 700 Pinsp TOemH20 (LO mbar, .0KPa, | TomM20(7 mbar, 0.7 KPa, 7 | 10cmN20(10mbar, LOKPa, 10hPa, 8 mmHg) ha, 5 mmHg) 10hPa, 8 mmHe) Rate 10 16 2 TE 12 12 12 Tinsp 170 10 PEEP OF Off of Psupp BemH20 (mbar, O.5kPa,5 | 3emH20 (3 mbar, 0.3 Ka, 3 ha, 4 mmHg) hPa, 2 mmHg) Prax ‘30 cmiF20 (30 mbar, SHPa, | 30 emN20(S0 mbar, SkPa, | AemN20 (AO mbar, APA, 30 hPa, 23 mmHg) 30 hPa, 23 mmHg) 40 nPa, 29 mmHg) Plimit 20 emiH20 (20 mbar, KPa, | 20 emH20 (20 mbar, 2 KPa, 20 hPa, 15 mmHg) 20 hPa, 15 mmtig) Insp Pause 0 0 Rise Time ToOTS TOOTS 100 ms Tig Window 25 25 Tigger 27min (0.03 //s) Ti/min(0.02/3) 2i/min(0.03 73) Blas Flow 3Y/min(0.05 17s) 2i/min (0.04175) ‘Simin (0-05 75) End Flow @ 5 Tow FIOZ a a High Fioz 56 Eg Tow MVexp 27min (0.03 1/s) Tin (0.023) High Mexp TOVmin(O-16/s) BY min(0.081/3) TowTvexr OFF Off High TWexp off off TowRR off off High RR ofr of Taw Et02 off off High E002 Off Off Tow EtC02 35 (3 Wa, 23 mnie) ‘3 (Wa, 23 mime) High E102 B% (8 ¥Pa, GO mmHE) ‘BR (8 Wa, 60 mime) Wave Field 3 Vol Volume) Vol Volume) Digit Feld Compl Compl (Pulmonary Mechanics) (Pulmonary Mechanics) Split Seren None None ‘Alarm Volume a a 10/08 45Engstrém Ventilator 4.3 Calibration menu ‘Menultem | Message text Comments ‘02 Fev | Start 02 Flow Control Valve callbration and leaktest, ‘Air ECV | Start AirFlow Control VaWve calibration and leaktest, Exhalation Valve | Patient must not be connected to cireutt during calibration. Start Exhalation Valve calibration Backlight Test | Start aisplay backlight test Gas Calibration Start gas calibration. Calibrate CO2 and 02 measurements. Gas Calibration is enabled whenever an MGAS module is installed. Gas Calibrations disabled ifthe MGAS ‘module is warming up. 46 Cal Flag | Turn the Calibration required When Cal. Flagis setto On, the message On/Off, “Calibration required” message is displayed in the general message area Previous Menu | Return to previous menu, Note The Cal, Flag menu item is used by the factory to activate the “Calibration required” alarm. Itis set as a reminder that calibrations must be performed when the machine is set up for operation atits permanent location. ‘After completing the 02 FCV, Air FCV, and the Exhalation Valve calibrations, sot the Cal. Flag to Off, 10/04 1805.1018.000,4.4 Service menu 4 Installation and Service Menus Use the service-level password to access the Service menu: "34-22-14." Whenever service menu is entered, “Enter Service dd-mmmn-yyyyhh:mmess” is recorded in the Event log. Message text Configuration Setlanguage, altitude and units, Copy Config, Save or instal configuration and default settings using memory card, Service Log. ‘Show error, event, and alarm histories and system information. Bit 1805-018-000 10/08 ‘Tum poweroffto exit menu arEngstrém Ventilator 4s 4.4.1 Configuration Menultem | Message text Values Comments Decimal Marker | Select decimal 0.01,0010r0,01 | Default: 0.0% delineator Language | Solectlanguage for | Chinese(simplified), | Defaurt: English screen, Czech, Danish, Dutch, English, Finnish French, German, Greek, Hungarian, taian, Japanese, Norwegian, Polish, Portuguese, Russian, Spanish, Swedish, Turkish Paw | Change Paw units: | kPa, omH20, ormlar | Default: emH20 kPa, cmH20, mbar. Flow | changeflowunits: | \/min ori/s, Default: i/min Venn ors 02 | change COZ units: | %,KPa,ormmHig | Default °%, kPa, ormmig, Height | Change height units: | emorft Default: em emorft Weight | Change weight units: | kgorlb Default: kg. kgorlb ‘Altitude | Change alttude used | -400t03000m | Default: 300m forgas-calculations. | in 100-m increments 10/04 1805.1018.000,4.4.2 Copy Configuration Copy Configuration menu 4 Installation and Service Menus ‘Menuitem | Message text Values Comments ‘Saveto Card | Save Configuration and | , Fail, or OK. ‘Saves al settings defaults to card, thatare nothardware Thefieldis blank untlthe | dependent, including data has either been facility defaults, itten to the card (OK) or | screen configuration, the system determines | trendsettings, colors, cannotwriteto the card | units, decimal (Fain, marker, altitude, patient type, backup settings, and the ‘Show Alarm Limits selection Copy rom Card | Copy Configuration and | ) shut-off valve. 8, Remove the test setup, the span calibration is aborted or failed, the last known goad calibration willbe used. 10/04 1905-1018-000,5 Service Tests and Calibration s505-1018-000 10/08Engstrém Ventilator 5.2.8 Verify operation of free- breathing valve Ensure both manual shut-off valves are closed. Connect a negative pressure squeeze bulb to the INSPiratory outlet. Fully depress the bulb a minimum of 10 times. On the VCB screen: * Verify that the measured Inspiratory Pressure is more positive than -3 ombi,0 at al times. * if ot, troubleshoot the free-breathing check valve and the inspiratory effort valve Disconnect the squeeze bulb from the INSPiratory outlet. 10/04 1905-1018-000,Engstrém Ventilator 5.2.9 Verify operation of inspiratory effort valve 1. Ensure both manual shut-off valves are closed. 2. Onthe VCB screen: + Energize (@) the Auxiliary Pressure Purge valve + Energize (close) the inspiratory effort valve (Gl Ettort Valve Energized) * Verity that the Air Flow Vah energized (2). * Set the Air DAC, 02 DAC, and the Exhalation DAC counts to 60,000. Connect a negative pressure squeeze bulb to the INSPiratory outlet. (02 Flow Valve and the Exhalation Flow Valve are Plug the ExPiratory inlet and the Auxiliary pressure port (Paua). Fully depress the squeeze bulb. * The bulb should not fully inflate in less than 30 seconds. * if not, troubleshoot the inspiratory effort valve. Disconnect the squeeze bulb from the INSPiratory outlet. De-energize (open) the inspiratory effor valve (Effort Valve Energized). 8, Set the Air DAC, 02 DAC, and Exhalation DAC counts to zero. 10/04 1905-1018-000,5 Service Tests and CalibrationEngstrém Ventilator 5.2.10 Verify operation of auxiliary pressure relief valve Connect a manometer to the auxiliary pressure port (Pau) using a tee fitting and a short piece of 3-mm (1/8 inch) tubing, Open the manual Airshut-off valve, On the VOB screen: + Energize (Z) the Auniliary Pressure Purge valve, Block the outlet of the tee. Verify that the pressure indicated by the manometer (not the PC based application) is greater than 90 cmH0 but less than 230 cmH,0. ‘Caution: Do not allow the pressure to build up over 250 cmH0. * if not, troubleshoot the relief valve, Close the manual Air shut-off valve. Remove the test setup, 10/04 1905-1018-000,5 Service Tests and Calibration s505-1018-000 10/08 519Engstrém Ventilator 5.2.11 Mechanical 1. Verity thatthe ventilator passes the low pressure leak test (Section 5.2.4). overpressure valve >. Tum the ventilator off test 3. Usingaa syringe, inject 60 mi of air into the ventilator through the INSPiratory por. 4, Afterthe entire volume is delivered, vei that the pressure reading on the manometeris less than 130 cm20. * if not, troubleshoot the safety relief valve. Note: Pressure may spike higher than 130 cmH20 during 60 ml volume delivery i delivered ata rate greater than 4 I/min. ToManometer KY \ 520 10/04 1905-1018-000,5 Service Tests and Calibration ToManometer 1905-018-000 10/08 satEngstrém Ventilator 5.2.12 Verify regulator output pressure Air regulator 0, regulator ‘The regulator output pressure should be checked during battery replacement intervals cor whenever the unitis already opened for other reasons. 41. Remove the plug rom the Air regulator outlet test port 2. Connect test pressure gauge to the Air regulator outlet test por. 3. Open the manual Air shut-off valve. 4, Onthe VCB screen: * Verily thatthe Alr Flow Valve is energized (2) * Adjust the Air DAC reading (start at approximately 9,500) Until the Air low reading is 15 |/min. 5, Verity that the test gauge indicates 172 + 0.69 kPa (25 + 0.10 psi) Ifrequited, adjust the regulator. * Be sure to tighten the locking nut after adjustment, 7. Close the manual Airshut-offvalve, 8, Remove the test gauge and plug the test por. 1. Remove the plug trom the 0» regulator outlet test port. 2, Connect atest pressure gauge to the 0» regulator outlet test port. 3, Open the manual 0, shut-off valve 4. On the VB sereen: * Verity that the 0, Flow Valve is energized (2) + Adjust the O DAC reading (stat at approximately 9,500) Until the Airflow readingis 15 l/min, 5. Verify thatthe test gauge indicates 172 + 0.69 kPa (25 + 0.10 psi) If required, adjust the regulator. * Be sure to tighten the locking nut after adjustment. Close the manual 0, shut-off valve 8. Remove the test gauge and plug the test por. Air Adjust 0 Regulter — of Tester ? 10/04 1905-1018-000,5 Service Tests and Calibration s505-018-000 10/08 523Notes 524 10/04 1905-1018-000,In this section AS WARNINGS 1805-018-000 10/08 6 Maintenance This section covers the regular maintenance procedures (minimum requirements) needed to make sure that the Engstrm Ventilator operates to specifications. 6.1 Engstrém Ventilator planned maintenance .... we we 62 6.1.1 Every twelve (12) months 2.2... oe we 62 6.1.2 Every forty-eight (48) months. 62 6.2 Battery capacity test 63 Do not perform testing or maintenance on the Engstrém Ventilator while itis being used on a patient. Possible injury can result. Items can be contaminated due to infectious patients. Wear sterile rubber gloves. Contamination can spread to you and others. Obey infection control and safety procedures. Used equipment may contain blood and body fluids.Engstrém Ventilator 6.1 Engstrom Ventilator planned m. tenance ‘Serial Number Date: (¥Y/MM/DD) v7 Hospital: Performed by: 12 months 124 month Tas month 6.1.1 Every twelve (12) months Oo ooo0o0go0g0ogono0 Oo 6.1.2 Every forty-eight (48) months Oo 62 Perform the follawing steps every 12 months. For details, eferto the sections listed. Itrequired, adjust the Display Unit arm joints (Section 9.5). Irequited, adjust patient monitoring module rack arm. Visually inspect Vent Engine fan fiter. Clean or replace as needed. Visually inspect Display Unit fan filter. Clean or replace as needed. Visually inspect exhalation valve assembly. Clean or replace as needed. Visually inspect gas inlet filters (0, and Air) Replace as needed. Complete the battery capacity test (Section 6.2). Electrical safety tests (Section 3.5). 9. Complete all Service level tests and calibrations (Section 5.2). 10. Complete all Super-User level tests and calibrations (Section 5. 1). 11. Complete the Checkout procedure (Section 3). In addition to the 12-month requirements, replace the follawing parts every 48 months. All parts should be replaced before performing the checks, tests, and calibrations, 41, Replace the system batteries* (Stock Number 1009-5682-000), "Note: Referto the “Battery capacity test” Section 6.26 Maintenance 6.2 Battery capacity test 1905-018-000 10/08 Test procedure ‘Athough replacement ofthe backup batteries is recommended atthe end of ‘years, batteries that pass the capacity test can be considered viable for battery backup of the system for up to 6 years at the discretion of the hospital Before testing the batteries, ensure that they are fully charged. Tum the system on and start a case (simulated). Disconnect the power cord from the mains outlet. Allow the system to run on battery until it does an orderly shutdown, Reconnect the power cord to a mains outlet. Boot the system with the PCMCIA Service Application and access the Power Diagnostics function as detailed in Section 8, * On the Main Menu of the Service Application, select Power Diagnostics. * On the Power Diagnostic menu, select Power Control. 6. Page 1 ofthe Power Controller Power Diagnostics screen shows the ‘Date battery Tested’ (the last full battery discharge) and the ‘Discharge Time’. * Ifthe ‘Discharge Time’ is greater than 60 minutes, the batteries can be leftin service for one more year. * Ifthe ‘Discharge Time's less than 60 minutes, both batteries should be replaced. 6Notes ee 10/04 1905.1018-000,7 Troubleshooting Inthis section 7.1 Troubleshooting Checkout Failures 12 7.4.1 Paw Transducer Check 12 7.1.2 Barometric pressure test 72 7.1.3 Low Pressure Leak and Compliance Check 13 7.1.4 Safety Valve Relief and Back Pressure . we oe 13 7.1.5 Bxhalation Valve Calibration Check... we we 74 7.4.6 Exhalation Flow Sensor Calibration Test 14 7.1.7 Measure Breathing CrcuitResistance 74 7.1.8 Air Inspiratory Flow Sensor Calibration Check 15 7.1.9 0, Inspirator Flow Sensor Calibration Check ........ oe 75 7.1.10 Og Sensor Test and Calibration ...... we we 75 7.2 Troubleshooting Vent Engine Leaks 7.3 Alam message troubleshooting chart 7.4 Troubleshooting Service App messages 1-26 1505-018-000 10/08 rEngstrém Ventilator 7.1 Troubleshooting Checkout Failures 2 WL Paw Transducer Check TL Barometric pressure test ifthe Automated Checkout (Section 3.2) results in failures, referto the following sections to troubleshoot a specific failure. ‘The Paw Transducer Check can indicate a failure from four conditions: 41. Inspiratory Pressure Sensor Zero Failure: Test results indicate Fall and the Pinsp sensor out of range message is, displayed + Ensure proper connections. * Replace the Inspiratory Pressure Sensor board. * Replace the Inspiratory Zero Valve + Replace the Vent Control board (VB). 2. Expiratory Pressure Sensor Zero Failure: Test results indicate Fail and Pexp sensor out of range message is, displayed. * Ensure proper connections. * Replace the Expiratory Pressure Sensor board. * Replace the Expiratory Zero Valve. * Replace the Vent Monitor board (VMB). 3. Cannatachieve 34 cmH,0 pressure: Test results indicate Fall but no alarm message is displayed. + Ensure supply gas is connected. * Continue with othertests Ia significant leaks indicated during the Low Pressure Leak test, repair the leak then repeat this check. * Check respective Flow Control Valve for proper operation. 4, Paw insp and Paw exp are not within 4 cmbi,0 when pressurized to 340m H,0. Test results indicate Fail but no alarm message is displayed. * Use the Service Application to calibrate sensors (Section 5.2.7). + Replace the affected Sensor board(s) ot Zero valves, if calibration fils IF this check fails, all ventilation modes will still be available. Aailure indicates that the difference between calculated barometric pressure based on the input altitude, and the measured barometric pressure is greater than 20%. * Verify correct altitude setting, * Ifsetting is correct, calibrate the barometric sensor (Section 8.7.4), * Replace the Vent Monitor board (VMB) - recalibrate barometric sensor. If this check fails, all ventilator modes will stil be available and the calculations will use the input altitude as basis for absolute pressure, 10/04 1905.1018-000,7 Troubleshooting 7.1.3 Nofallures wll be indicated. there are errors in the calculation (negative Low Pressure Leak and values, divide by ero, et.) the results willbe dashed, The results ofthis Compliance Check _°2!"uation willbe displayed ater the Safety Rei Valve testis completed 1, The first calculation is compliance and is based on the amount of time it takes fora 3|/min flow to create 34 cmH,0 of pressure at the Pexp sensor. If this pressure cannot be achieved, no compliance information will be available, 2, The second calculation is the low pressure leak rate. Itis based on the amount of pressure decay trom 25 cmbi,0 pressute in approximately 3 seconds. Ifthe leakrateis greaterthan 1 L/min (@25 cmH,0),theleakand compliance values will be dashed. This value can be useful in diagnosing other failures during checkout 3, Finally, a correction based on the leak rate is applied to the compliance calculation and the information can be displayed, 7.1.4 The Safety Valve Relief test checks the ability of the Safety Relief Valve to Safety Valve Relief and ‘lieve al patient pressure on demand, Failures include: Back Pressure 1. Cannot achieve 30 emH,0 pressure. The test wll indicate Fall but no alarm message is displayed, + Ensure supply gas is connected. * Aleakis indicated; repairthe leak then repeat this check, 2. Once pressure stabilizes, the Safety Relief Valve is opened. fPexp does not goto less than 2 omtiz0 within 250 msec, the test will indicate Fail and Relief Valve Failure message will be displayed Use the Service Application to simulate this test. a. If pressure remains significantly above 2 cmH0: + Check the connections to the safety relief valve, ‘+ Ensure seat/seal interface is clean + Replace the Manifold Assembly. b. pressure is only slightly above 2 omlH,0: = Re-zero pressure sensors. ‘Ensure seat/seal interface is clean, ‘If Exhalation Valve Calibration Check also fails, replace the Pexp sensor, = Repeat check, 3. Ifa flow of 75 I/min creates more than 10 cmHy0 pressure at Pexp sensor with the safety relief valve open, the test will indicate Fall and Relief Valve Failure message will be displayed Use Service Application to simulate this test, * Check the connections to the safety relief valve. * Replace the Manifold Assembly. If this test falls, no mechanical ventilation is allowed. 1905-018-000 10/08 13Engstrém Ventilator 715 Exhalation Valve Calibration Check 7:16 Exhalation Flow Sensor Calibration Test TAT Measure Breathing Circuit Resistance ‘The Exhalation Valve Calibration check uses the same relief test as above ‘except with the Exhalation valve instead of the Safety Relief valve 1. Cannot achieve 34 cmH1z0 pressure. ‘The test wll indicate Fall but no alarm message is displayed * Ensure supply gas is connected. * Aleakis indicated; repair the leak then repeat this check 2. Ifboth the Relief Valve and Exhalation Valve tests fail and the leak rate is less than 2000, the most likely problem is with the Pexp Sensor not returning to zero: * Use the Service Application to apply 34 cm,0 of pressure untilstable, then release the pressure using either the Exhalation Valve or the Safety Relief Valve. The Pexp value must etum toless than 2 within 250 msec. If not, re-zero and repeat or replace the Pexp sensor. 3. Ionly this check is failing: a. Use the Service Application to verity atleast 3 l/min is generated by the FCV. Ifnot: + Recalibrate the FCV, ‘= Replace the FCV. b. Remove the Expiratory low sensor. ‘Ifthe check passes, replace the Expiratory Flow Sensor. Remove the Exhalation Valve Assembly and ensure the Voice coil shaft is clean and dry and moves freely without binding, d. Replace the Exhalation Valve Assembly. e. Replace the Voice coil assembly. If this check fails, all ventilator mades will stil be available, ‘The Exhalation Flow Sensor Calibration test compares the Exhalation Flow ‘Sensor output to the Total Flow Sensor output. 1. Ifonly this test fils, replace the Exhalation Flow Sensor. 2. Ifthe Airand/or02 Inspiratory Flow Sensorcalibration checks alsofail, use the Service Application to determine the accuracy of the Total Flaw Sensor. It this test fails, all ventilator functions will still be available. The message Flow Sensor Error vill be displayed ‘The breathing circuit resistance is calculated from the amount of resistance created when 60 I/min i flowing through the circuit. tis calculated and displayed on the bottom of the screen. It represents the resistance of 1/2 of the breathing circuit. 10/04 1905.1018-000,T.L8 Air Inspiratory Flow Sensor Calibration Check 7.19 0, Inspiratory Flow Sensor Calibration Check 7.1.10 0, Sensor Test and Calibration 1905-018-000 10/08 7 Troubleshooting ‘The Air Inspiratory Flow Sensor Calibration check verifies thatthe Air Flow ‘Sensors functioning and compares the flow and temperature measurements with the total flow sensor. 1. Ifboth the Airand O, Flow Sensors fail this check, replace the Total Flow Sensor. 2. Otherwise, replace the Air Flow Sensor. If this check fails, all ventilator functions will stil be available, The message FiAir Control Error will be displayed ‘This check verifies that the 0, Flow Sensoris functioning and compares the flow and temperature measurements with the total flow sensor. 1. Ifboth the Airand 0, Flow Sensors fail this check, replace the Total Flow Sensor. 2. Otherwise, replace the 02 Flow Sensor. It this check fais, all ventilator functions will stil be available. The message F102 Control Error will be displayed, This test/calibration will only be performed if both Air and O, are connected. The 0, offsetis calibrated while flowing 30 |/min of Airand the Op gain is calibrated with 30 min of O,, Calibration is verified by flowing 15 l/min Airand 15 /min 0, and comparing the sensor output to the calculated valve (approximately 60.5%). If this check fais, all ventilator functions will still be available 15Engstrém Ventilator 7.2 Troubleshooting Vent Engine Leaks Itthe vent engine leak test (Section 5.2.4) fails, * citherif unable to build 70 cmH0 pressure, + or ifthe leak rate exceeds 10 ml/min, the following steps will help to narrow down the possible leak locations. While retaining the leak test setup: 41. Close the Airand 0 flow valves to limitthe components tested (remove the checkmarks from the boxes next to the DAC counts). 2. Repeat the Vent Engine Leak est. + Ifthe test passes, proceed to step 5. + Ifthe leak remains, toggle the Effort Valve closed, 3. Repeat the Vent Engine Leak Test * Ifthe system passes, check the Free Breathing Valve diaphram and o-ing seal + Ifthe leak remains, toggle the safety valve open/closed. 4, Repeat the Vent Engine Leak Test + Ifthe system passes, check the safety valve seal * Ifthe leak remains, check the individual components in the Total Flow path. 16 10/04 1905.1018-000,7 Troubleshooting s505-1018-000 10/08 uEngstrém Ventilator 5, Open only the Op flow valve by checking the 02 Flow Valve box (verify that 60000 DAC counts are set). 6, Repeat the Vent Engine Leak Test * Ifthe test fails, check the individual components in the 0» Flow path, * Ifthe test passes, check the individual components in the Air Flow path. 18 10/04 1905.1018-000,7 Troubleshooting s505-018-000 10/08 19Engstrém Ventilator 7.3 Alarm message troubleshooting chart Whenever *Check/replace hamess" is indicated, ensure that al terminals are fully inserted into the connector body window and that all wires are properly crimped, Troubleshooting guidelines are listed in order of probability. The entie ist does not need to be carried outif the problem is resolved. The list may not include all possible solutions. * Alarm message splay message + Alarm ID = message in Ertor log or Event log [Alarmimessage [Alarm ID Priority ‘Alarm Condition ‘Special Behavior/Comments| + Aetion/ Troubleshooting -none- [DU RAM Error Failed [Selftestfaiure ormutibiterror Run Backup Ventilation ifin detected. Therapy. none [Therapy Power Off |High [Power switch is setto Of. + Normal operation if On/Standby switch is moved to standby while in terapy. + Verity vents in standby state prior to turing power On/ Standby switch to standby. + Check/replace harness to On/Standby switch, + Check/replace On Standby switch. + Checl/replace PMB, [Air supply IAi'SupplyPres High ]Low | Airsupply pressure > 95 psigfor more pressure high than 0.5 seconds + Chock irsuppWy + Disconnect sensor and very outputs zero gauge pressure + Interchange hamess connections on bath supply pressure sensors. + Ifalan follows the senso, replace supply pressure sensor + ltnot, check/replace VMB. ir supply IAi'Supply Pres Low [Medium [Airsupply pressure <243 psigfor __|Unitshuts down Airsupplyand pressure low more than 0.5 seconds delivers 100% Oxygen Flow Wave: (02 only + CheckairsuppWy + Disconnect sensor and vey output is zero gauge pressure + Interchange hamess connections on bath supply pressure sensors. + If alam follows the sensor, check sensor connector terminal. Replace supply pressure sensoritnecessary. + Hf nt, cheok/teplace hamess + Ifnot hamess, chech/replace VMB. 140 10/08 1506-1018.0007 Troubleshooting [Atarmmessage [Alarm ID Priority ‘Alarm Condition ‘Special Behavior/Comments| + Action/ Troubleshooting [Air temp high [Temp High High Total flow sensor temperature > 480. ]Switch to 100% 02. Airis turned off regardless of Flow Wave: other alarm conditions (for [02 only example, 02 Supply Low). When he condition clears, the lvent changes back to previous known good set 02 modure With a airflow of approx (Check inlet air temperature Use Senvice App to check temperatures of air and total flow sensors. Itinlt air temp is NOThigh, and iftemp from total low sensor reports more than 9°C higher than the air sensor, replace Total Flow Sensor imately 10 Vin, very air and total flows ar within 10% of each other. [Air temp sensor [AirTemperature Sensor Failure Low (Out of range airtemperature sensor data (range is 0-60 degrees C), Use total low temperature for lair flow sensorcalculations, including alarms, total flow sensor temperature not avaiable, use 50°C, Replace sensors. Check inlet airtemperature If comm. Failure alarm is also active, check hamess connections. With gas suoplies disconnected and system temperature stabilized, use Sewice App to check temperatures of airand total flow sensors. Airflow sensor and total low sensor shall not tf by mare than 9°C. Backup audio [Backup BuzzerPOST Medium |Gurrentto buzer Indicates audio snot |This alarms logged at start. allure |sounding. up and can be de-escalated butcannot be cleared from the screen, ‘Check hamess connection between PMB/On-Standby switch, + Verify buzzer current with voltage measurement at TP15 on VCB. If voltage IS NOT present, replace PMB. If voltage IS present, replace VCB. Backup mode [Backup Mode Active Medium [Spontaneous breathingis insufficient [Uses PCV mode and preset active or Display Unit failure. settings (customer [system goes into Backup Ventilation | configurable) mode, Ensure the patient's spontaneous breathing and ventilatory support is adequate. This alam could be tviggered by user errs regarding patient ventilation requirements, See URM for details. Check error log for communication erors or DU errors. 1505-018-000 10/08Engstrém Ventilator |Alarm message [Alarm ID [Priority Alarm Condition ‘Special Behavior/Comments| + Action/Troubleshooting (Check D-fend__JMGAS Sample Line Not [Medium [MGAS communicates the sample] The pump turns Off. connected >40 See lubingorthe D-fend moduleisnot _|IfNormal Sceenis selected [c02 or02 wave installed the DU commands the MGAS instruction to start sampling again Check D-fend Wait 30 sec and ress Normal Screento continue. + Check iat the sample bes connected + Check thatthe water tapi connected + Check thatthe gas outlets not blocked. + Replace Mocule. [check sample JMGAS Check Sample [Medium [MGAS communicates continuous The pump turns Off. lgasout [Gas Out> 20 See occlusion for20 seconds Noel Screnis selected, the DU commands the MGAS coz oroz to start sampling again, waveform instruction: [chock sample gas lout. Wait 30 sec and press Normal Screento continue. + Check te gas outlet. + Replace modi. [connect [Nebulizer nat law |Nebulzer disconnected while nebulizer connected nebulization procedures running. + Re-connest Nebultzr. + Replace Nebulizer cable + Replace Nebulizer hea. + Replace Nebulizer board [Contrals frozen. |frontPanelCom Fal! |High [Key pad controler fails to sond We tick [DU to allow pow off [Need service {or greater than 10 seconds confirmation, even in Therapy. (he Paneriock popup wl ot appear) + Ojele power + Replace Keypad Controller Exp flow sensor [Exhalaton Flow Sensor JHigh [Failed communications with exhalation [Use open Toop pressure allure [communications tow sensor contol Faiue + Check hamess connection between VMB and exhalation flow sensor PCB. + Replace extalation flow sensor PCB. + Replace VMB. Fans require Fan Fai Medium |Fan Power Status Bis formain fan or service Ncorfan sow. + Check connections to fans. ‘+ Replace broken fan(s). na 10/04 1505-1018-0007 Troubleshooting [Atarmmessage [Alarm ID Priority ‘Alarm Condition ‘Special Behavior/Comments| + Action/ Troubleshooting Fi02 controterror [Air Flow Sensor Medium JLoss of communication Use Open Loop valve mixture [communications contol. Failure Return to closed loop volume delivery control when cleared. (Check Eiror Log for Air/02 Insp Flow Sensor Supply Voltage. + ityes: Disconnect vent engine hamess at airflow sensor. I voltage error stops, replace ai flow sensor. -Disconnect vent engine hamess at 02 flow sensor. Ivltage enor stops, replace 02 flow sensor. Disconnect vent engine hamess at VB. I voltage error stops, replace hamess. Ino: Check connection to Ai Flow Sensor. -Interchange harness connection between ar and total low senso. -Ifproblem stays with sensor, replace sensor. falarm follows harness, check/replace hamess. Whamess is Ok, replace VCB. Fi02 control error _ [02 Flow Sensor Medium JLoss of communication, Use Open Loop valve mixture [communications conto Failure Return to closed loop volume delivery control when cleared. + Check Eror Log for Air/02 Insp Flow Sensor Supply Voltage. tyes: Disconnect vent engine hamess at airflow sensor. Ifvollage error stops, replace ai flow sensor. -Disconnect vent engine hamess at 02 flow sensor. I voltage enor stops, replace 02 flow sensor. Disconnect vent engine hamess at VB. I voltage error stops, replace hamess. = Ifno: Check connection to 02 Flow Sensor, -Interchange harness connection between 02 and total low sensor. -Ifprotlem stays with sensor, replace sensor. alarm follows harness, check/replace hamess. Whamessis, Ok, replace VCB. Flow sensor error __|Exhalation Flow Sensor [Medium [(TVexp - 1Vinsp)>(0.3* TVingp) or [Freeze vent engine volume [comparison 100 mL whicheveris greaterfor6 | compensation on first breath consecutive breaths, detected, + Using Service App, very Inspiratory flows match Expratory flow within tolerance stated above. + Roplace expiratory sensor as necessary. + Replace exhalation flow sensor board FSB) internal power JPMBDC-DC Fail Medium JAC supplyis OK but batteries are being allure discharged. + Check serew terminal connections and hamess between AC-DG power supply and PMB “Check use F1. fnat 0, replace PMB. + Replace AC-DC power supply. (Mixed gas temp iotaiFlow Temperature low |Out ofrange total temperature sensor [Use airflow temperature for |sensor error Sensor Failure data, {total flow sensor calculations, including atatms. Ifairflow sensor temperature not avalable use 50°C, (Check inlet air temperature. If comm. Failure alarm is also activ, check hamess connections. ‘= With gas supplies disconnected and system temperature stabilized, use Service App to check temperatures of airand total flow senso. If ether reports temperature out of range (0 to 60°C), replace that sensor. 1505-018-000 10/08 ayEngstrém Ventilator [Alarm message [Alarm ID Priority ‘Alarm Condition Special Behavior/Comments| + Aetion Troubleshooting Module fall.No JMGAS Sensorinop > [Meum ]MIGAS communicates hardware falure (co2, 02 data [RAM fale, ROM checksum er, Error in CPU EEPROM, Error 2 preamp EEPROM, Erorin SSSboard EEPRON, ottage error, or Lamp contol tau.) + Roplace Module Module not [Module Not Compatible|Low |The monitoring module detected is nat [compatible compatie with system software. The Vis designed to wrk withthe {lowing Compact Away Modules: SW Version 3.2 and above of M-C, M- C0, N-COV, N-COVX, M-CAIO, M- CAI, and M-CAIOVK. + Remove and reseat Module. + Check sotware revision inthe Sewice Log + Replace Mocile. [Negativ aieway |Negatveressure ]ligh |Pawinsp or Paw exp <-10 oml20_Latchedalam, pressure PEEP numeric highlighted in red + Compare Insp and Exp sensor values using the Sewice App atzoro and 100 om/#H20. The Insp and Exp pressure sensors should match within £5 emH20 (while at O cmH20 tue pressure) and #10 omH20 (while at 100 cmli20 tue pressure) + Calibrate pressure sensors + Reterto pneumatic roubeshoating section for testing zesing vale + Check hamess connection on VCB and VMB. + Replace sensoras needed [No battory [Degraded Batory Medium |The total battery voage is <2OVDC backup or Each battery voltages <10vDC + Verfyunithas been connected to mains for more than 24 hows + Checkerrorlog for related messages. + Use Senice App to determine charge state fin tickle charge, replace batteries, + Check/replace hamess. + Checi/replace PMB, 14 10/04 1805-1018.0007 Troubleshooting [Alarmmessage [Alarm ID Priority ‘Alarm Condition ‘Special Behavior/Comments| + Astion/ Troubleshooting INo battery |DUto PMB .Com Error Medium [Communications from the DUto the [PMB assumes failed state and lbackup? -or- power controller cannotbe established | allows system to shutdown [PMB to DU Com Error ior 10 seconds, without confirmation from DU, -or- (is alarm allows vento be (Communications from the power | shutdown if DU contralerto the DC cannat be [communications is lost) established for 10 seconds, Note question mark atend of message and no battery status indicator on display ‘+ Check erorlogs for telated messages: ‘Check communication (no sofware information indicates no communication). « Ifmultple fallures, replace DU CPU board * Check / replace cisplay cable. + Check (reseat) all connections on all PC boards. * Check/replace DU interface board, + Replace motherboard + Replace PMB, No battery [PMB POSTFailure Medium [Power contvller failed CPU selftests _ [Note question mark at end of lbackup? message and no battery status indicator on display + Gycle power «+ Replace PMB. [No battery [Battery Charge Fall Medium |Ihe systems powered on with a lbackup -or- battery curent>1.3 amps, [Standby Current High -or- System is in Standay and the charge current is >1.7 Amps. + Gycle power. + Check/replace hamess. + Replace Power Supply. + Replace PMB, No battory [Battery Fai Medium |While bulk, over, orfloat charging any [Battery status indicator lbackup batteryis <10.5VDC (short) appears under clock. Battery has been charging for >24h while powered on (sulfated) Voltage >16.5V during bulk or over charging and normal cutrent>0.25 amos (sulfated), + Gycle power. + Check/replace harness. «+ Replace batteries. 1505-018-000 10/08Engstrém Ventilator [Alarm message [Alarm ID Priority ‘Alarm Condition ‘Special Behavior/ Comments] + Action Troubleshooting [No battery Battery Missing Medium [Any battery voltages between -1.0 [Battery status indicator backup and +1,0VDC, appears under clock + Cycle power. + Chock connections/replace hamess. + Cheol replace fuse. + Roplace batteries [No battery [Battery Reversed [Medium [Any battery voltage isless than Battery status indicator backup [connection |1ovoc appears under clock + Gyole power. + Check connections to battery + Replace batteries. + Replace PNB, [No battery ‘Seif Test Fail Medium [Power controlerfalled selftests [Battery status indicator lbackup (memory, vokages, or CPU) appears under cock + Cycle power. + Replace PMB [No battery [Standby Bulk Charge> |Medium [System sin Standby and the charge backup 2s mode is bulk charging andthe duration has exceeded 12 hours. + Check connections + Replace batteries. + Replace PNB, [No exp flow INo ExhalFiow Sensor High [No xhalation Flow Sensor connected [Use Open Loop pressure sensor contra. + Check Exhalaton flow sensor connection + Replace Exhalation Flow Sensor += Verity low pressure leak test passes. + Check/replace interface PCB ane flex circuit + Check/replace exhalation flow sensor PCB. INo gas supply [No SupplyPressure ]High [O2 supply pressure and airsupply | Continue 100% gas flow of pressure pressure <24.3 psig formore than 0.5 |whichever gas has the higher seconds pressure value atthe onset ot the alarm; fboth are equal, use 100% 02, + Check 02 and Airsupply pressures. + Check/replace hamess between sensor and VMB, + Chock rrorlog or reference voage errs. + Cheol replace VM. [02 SensorFail Medium [Out of range 02 sensor (Paracube) ata greaterthan 103% or communication error + Calibrate 02 sensor wth Checkout (ensure both Ar and 02 gas supply ae connected). + Calibrate 02 sensor with Service Anp (ensure both Ai and 02 gas supply are connected). + Verity 02 Concentration sensor votage eroris not present in erorlog + Check replace harness. + Check/replace 02 sensor. + Checl/replace VB. 10/04 1805.1018-000,7 Troubleshooting (Alarm message [Alarm ID Priority ‘Alarm Condition Special Behavior/Comments| + Action Troubleshooting [02 supply [02 SupplyPres High Jlow [02 supply pessure> 85 psig or mare Pressure high than 0.5 seconds + Check 02 supply + Disconnect sensor and verity output Interchange hamess connections o It alarm follows the sensor, replace not, check/replace hamess, Inot hamess, check/teplace VMB, iis zero gage pressure n both supply pressure sensors supply pressure sensor. [02 supply [02 Supply Pres tow Medium pressure low Flow Wave: Air only [02 supply pressure <24.3 psigfor more than 0.5 seconds. Laiched De-escalatable Go to 100% Air, + Check 02 supply. Interchange hamess connections 0 Ifnot, check/replace hamess. h "1 M1 I not hamess, replace VMB. + Disconnect sensor and verity outputis zero gauge pressure mn both supply pressure sensors. i alarm follows the sensor, check sensor connector terminals. Replace supply pressure sensorif necessary [02 temp sensor [02 Temperature Sensor |Low lerror allure [Out ofrange 02 temperature sensor data. (range is 0-60 degrees C) + Check inlet 02 temperature + Replace sensors, + ifcomm. Fallure alarms also active, check hamess connections. ‘+ With gas supplies disconnected and system temperature stabilized, use Service App to check temperatures ‘02 and total low sensors. 02 flow sensor and total flow sensor shall not differ by more than 9°C, [Onbattery [Low internal Medium [Mains power not available. [Battery - 30, Internal battery supply <30 minutes Min calculated via battery discharge algorithm. lonbattery lon Medium |Mains power not available System Battery powered by internal battery for more Ithan 300 ms. ‘+ Normal alarm system is operating + Chack/replace fuse F1 on PMB. + Replace PMB, on batten. ‘+ Check connection to AC supply (vey green LED on DU sit += IFLED isnot Ii, check AC mains source, check rear power cord clamp, check fuses, ‘+ IFLED sit, check output of DC powersupply at screw terminals. Ranges 20-32 V. fout of range, disconnect DC power supply input hamess and very outputs stl out of range. Check/replace DC power supply input hhamess. If out of range and hamess is OK, replace DC power suppl. ‘+ Measure voltage atF1 (both sides) on PMB. Range is 20-32V. 1505-018-000 10/08Engstrém Ventilator [Alarm message [Alarm ID Priority ‘Alarm Condition Special Behavior/Comments| + Aetion Troubleshooting Palrsensoroutof |AirSupply Pressure Jlaw _[Outofrange Airsupply pressure sensor range [Sensor OutofRange ata, Range is 195 to 4760 mv + Check Airsupply + Disconnect sensor and verity outputis zero gage pressure. ‘+ Interchange hamess connections on bath supply pressure sensors. + Ifalarm follows the sensor, check sensor connector terminals, Replace supply pressure sensorif necessary + Ifmot, check/replace hamess, + Ithamess OK, replace VMB. Patient [Standby Patient High | Paw insp or Paw exp>3 omH20 when [Non-sllencable lconnected? Detection bias flow setto 3 l/min air or 02 (if ir | Audible in Standby and not available) and exhalation valve set |Monitoring states. Io 6 cmH20 for 3 seconds. When placed in Standby state ether by the user or after power up, the ventilator wil maintain a bias Now so as to detect fa patient has been attached to the circuit. This functionality alerts for an inadvertent attachment ofthe patient withoutthe user actuating ventilation. + Was patient connected during standby state? ifyes, this s a user error. no! + Remove all tube connections from vent. If alarm persists, check exhalation pressure port and exhalation valve housing «+ Calbrate Flow control valves. + Calibrate airway pressure vansducers. «Using the Service App and occluded circuit, set /min low, and set 6 cmH20 on exh. Valve. Ensure both Insp and Exp pressure sensors read 6 +3 cinH20, Open circuit and vey pressure is <2.cmH20. + Check/replace zero valves + Replace appropriate pressure sensor board + Replace appropriate flow contvol valve. Pauxhigh [Pauxigh Tow Paux> 100 emi20 DDe-energize Paux purge valve (itpurge valves energized) unt alarm condition clears, «+ Verify Paux port (and any tubing thatis connected to Paux por) is rot occluded when purge valve is energized (ourgeis tuned ON). + Zero Paux pressure sensor. + Use the Service App to calibrate the Paux pressure sensor (Section 6.2.7). + Interchange Paux ane Pexp connections. if Paux hgh alarm stops, replace Paux sensor. + IfPaux High alarm continues, replace VCB. Pauxsensorout |PaixSersoroutof |low _ |Pauxsensor data outof range. lofrange range Range: 10-4095 mv + Check/replace hares. «Interchange Paux and Pexp connections, If Paux alarm stops, replace Paux sensor. + IfPaux alarm continues, replace VCB ras 10/04 1805.1018-000,