: Q MONNAL Te 0 Maintenance manual This maintenace manual is valid for softawre versions higher than or equal to v1.0.0 » www.airliquide.com | www.airliquidemedicalsystems.comIntroductio ‘symbols used in this maintenance manual. Typography. ACRONYMS & ABBREVIATIONS. ‘Symbols and markings on the device. GENERAL SAFETY INSTRUCTIONS. REGULATORY REQUIREMENTS... 1. description of OPERATION. Exterior description. 1. Front view 2. _ Right-hand side: patient interface 4 3. Left-hand side: fluid interface 14 4. View from below 15 Principle of operation Functional description.. 4. Function flowcharts 2. Electronic sub-system 7 3. Mechanical sub-system 2 1.3.4. Pneumatic sub-system 26 Pneumatic operation, Operation of ventilation 27 Electrical power sources. Power supply management 30 Description of the pneumatic components... 1. Micro blower unit (T) 2. Mixer unit 3. Expiratory valve .6.4. Hot wire expiratory flow sensor (FS2) 5. Mass flow sensor (FS1 and FS3) 6. Pressure sensors 7. FiO, CELL (0,8) 8. Temperature sensor (TS) Description of circuits 17.1. Pneumatic circuits 1.7.2. Electrical wiring 2, Equipment required for maintenance. 3. Access to the maintenance menu. 4. software update... 4.1. Accessing the update screen. 42. Connection, 4.3. Preparing the pe 45 4.4, Downloading, 45. Checking the downloading 5. Downloading the black box. 5.1. Black box downloading procedure via usb key 5.2. Hardware configuration via USB cabl 5.3. Accessingthe download screen 5.4. Blackbox downloading procedure6. Downloading the white box 6.1. Hardware configuration. 62. Accessingthe download screen... 6.3. White box downloading procedure. 7. Annual preventive maintenance... 7A. Definition. 7.2. Flowchart.. 8 Corrective maintenance. 8.1. Flowchart.. 82. Procedure for emergency shutdown... 8.3. Alarm messages. 8.4. Diagnostic aid list of alarms .. 9. Disassemblylreassembly procedures 9.2. Disassembly -cceccnnenenne 10. Calibration and operating checks. 10.1. Introduction .. 10.2. Checking or replacing part 10.3. Functional check of touch screen. 10.4. Functional check of usb port 10.5. Sensor calibration.. 106. 10.7. 10.8. Switching off the unit. 11. CALIBRATION. 41.1. Accessto the calibration screen. 11.2. Using the calibration scr 11.3. Calibrating the machine .. 11.4. Automatictest: 41.5. Calibration. 12. SPARE PARTS AND CONSUMABLES. 12.3. TOI amninnenensnne 13. Electricalsafety checklist. 14. MONNAL T60 ‘RETURN TO SERVICE" SHEET.Q MONNAL_Teo INTRODUCTION This document is a maintenance manual, and does not serve as a replacement for the user manual. It is a complementary document to the user manual, and is aimed at trained personnel who are competent and ayalified to perform preventive maintenance and /or corrective It contains technical information belonging to Air Liquide Medical Systems, which may not be divulged except with the company’s prior consent. YM033000 / Rev. 1.3 / 12-2012 3Q MONNAL TE 9 SYMBOLS USED IN THIS MAINTENANCE MANUAL Z\ Caution Warns the user of the possibility of minor or serious injury associated with the use, proper or improper, of the device. y Warning Alerts the user to the possibility of a technical problem or device malfunction occurring, associated with the use, proper or improper, of the device. A Note Emphasises an item of information being given. TYPOGRAPHY Font Example Function Lucida Console Excessive pressure Text taken from screen Text directing the reader to , another chapter in the manual ltaie See Chapter 3.1 Text referring to the icons presented above Bold, italic Check on patient expiration EmPhasises an important point in a phase ACRONYMS & ABBREVIATIONS Abbreviation Meaning DC Direct Current SMD Surface-Mount Devices sv Solenoid Valve HMI Human-Machine Interface PV Patient Venting PEEP Positive End-of-Expiration Pressure PWM Pulse Width Modulation TFT Thin Film Transistor uP Microprocessor 4 YM033000 / Rev. 1.3 / 12-2012Q MONNAL TE SYMBOLS AND MARKINGS ON THE DEVICE 1P34 Manufacturer label Manufacturer Rompnasay iz Qirective o0/42/EC Catalogue Number of the device Serial Number of the device Date of manufacture: YYYY-MM Caution; refer to the instruction manual Class Il ‘Type BF device Protection Index according to the EN 60529 standard 3: protection against the penetration of solid bodies of diameter > 2.5 mm. 4: Protection from water splashes in all directions Power On button DC power supply connector USB connector YM033000 / Rev. 1.3 / 12-2012 Sw a O2 O2 iol Oxygen cell hatch open Expiratory valve eject button High-pressure oxygen inlet fitting Low-pressure oxygen inlet fitting Patient circuit inspiratory connection Patient circuit expiratory connection IRMA CO2 probe connector This logo means that the equipment must not be disposed of via ordinary waste disposal channels. It must receive appropriate end-o-ife processing in agvardence with irective 2002/96/EC WEEE. This device was manufactured after 13 August 2005. Internal battery operation indicator Interchangeable battery operation indicator Interchangeable lithium ion battery AC or DC power supply indicator VGA video outputQmor NALTE9 GENERAL SAFETY INSTRUCTIONS Use of oxygen Precautions in case of oxygen leakage: - Do not smoke - Avoid flames and sparks - Disconnect the oxygen source PS ReR ee RAGS SRE and at least 20 minutes after leakage. - Ventilate clothes worn. The machine must not operate in the vicinity of any incandescent source. This respirator should not be used with inflammable anaesthetic agents or explosive products. Do not use the machine with any items contaminated by flammable substances (grease, oil, etc.) The components inside the machine were degreased before delivery, or use oxygen- compatible grease. Do not grease or lubricate any part of the machine. Only medical-grade oxygen must be used, i.e. it must be dry and dust-iree (H20 < 20 mgim3). The supply pressure must be between 280 kPa (2.8 bar) and 600 kPa (6 bar). Wesgcommend that all oxygen sources be disconnected from the machine when it is not Electrical power supply All electrical installations on the premises must conform to IEC specifications. Check that the voltage on the mains socket used is a correct match to the electrical properties of the respirator (shown on the manufacturer plate on the rear) Use only the power supply cable and power supply box supplied with the machine. If an external DC power supply is used, check that the voltage and current match the electrical characteristics of the respirator (indicated on the side of the respirator). The AC power supply box is not protected from splashing water (IPX0), unlike the machine, which complies with IPX4 during battery operation. This respirator is equipped with an internal battery and an interchangeable battery: the machine must be connected to the mains regularly to maintain adequate battery charge. In-case of doubt concerning the AC power supply cable, use the machine on battery power only. Do not use anti-static or electrically conductive tubes. Electromagnetic Compati The functioning of the respirator may be affected if other equipment is being used in the vicinity of the device, such as diathermy equipment, high-frequency electro-surgery, defibrillators, mobile phones or, more generally, by electromagnetic interference exceeding the levels set under the standard EN 60601-1-2. Do not use this respirator in a magnetic environment (such as MRI, NMR, ete). 6 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 9 Connection to other electrical devices Do not connect it electrically to devices not listed in this user manual without first consulting the manufacturers concemed or a specialist. The devices connected to the signal inputs and outputs must comply with the 60601-1 Standard, Edition 2 (Article 6.8.2 c). Commissioning The device must not be commissioned immediately after storage or transport under temperature and humidity conditions different from the recommended conditions of use After each use, check that the audible and visual alarm is operating properly, and carry out the checks listed in the appendix (See Section IX.1, ‘Checklist’, in the User Manual). Use The manufacturer has anticipated most of the possible instances of malfunction which might occur on this respirator, and these are normally monitored by the internal surveillance system; nevertheless, it is recommended that where the patient is totally dependent on the device, that a supplementary system is provided, wholly independently, to monitor the effectiveness of the ventilation, as well as an emergency breathing device such as an ARREPRERSIBABYALASUVAlby a user are not in conformity with the manufacturer's, instructions, then the manufacturer is absolved of all responsibility in the event of an incident. Do not expose the device to direct sunlight. The device and its accessories (masks, circuits, etc.) are latex-free in order to avoid any allergy risk. The air inlets at the rear and the side of the device must be clear of any obstruction. For the device to operate from ambient air, a HEPA filter must be used at the respirator inlet, as recommended by Air Liquide Medical Systems. Do not use the respirator in an explosive or nicotine-laden atmosphere (cigarette smoke, danger, etc.). Persons intending to operate this respirator must be trained in its use. Only those who have fully read and understood the user manual are authorised to handle and use this respirator. This manual was written for the purpose of providing all the. information required to use this respirator, but it cannot replace a medical prescription, which is essential in order to determine the appropriate settings for the needs of the patient. Transport During transport, it is recommended that the device be used in its carrying case. The case must be firmly secured in the vehicle via the strap loops provided for the purpose. The device must not be subjected to any brutal impact when not in its carrying case. Exclusively use the carrying case recommended by Air Liquide Medical Systems. Maintenance This respirator should be checked regularly. To plan and keep a record of all maintenance operations, refer to the maintenance record in Appendix. According to EN 60601-1 standards (See Appendix A, Section 6.8.2.b): YM033000 / Rev. 1.3 / 12-2012 7Q MONNALT¢ 9 The manufacturer, the assembler, the installer or the importer shall only consider itself responsible for the effects on the safety, reliability and characteristics of a device if: “Assembly, extensions, software updates, adjustments, modifications or repairs have been carried out by persons whom it has authorised. The device is used in conformity with the instructions for use.” The qualified technician must use only Air Liquide Medical Systems replacement parts during periodic maintenance of the device. Do not use abrasive powders, alcohol, acetone or any other inflammable solvents. BSR EE IAP PAA STR Oe AG RNG e TS BPO AER SR BUIAS a SO necessary to wait until the internal temperature of the device has fallen to an acceptable level. Because the device is used in a hospital environment, it is prone to becoming contaminated by bacteria, viruses, or other organisms. Before any servicing, it is essential to ensure that the device has been decontaminated and to apply the personnel protection procedure in force on the site, as well as the procedure recommended by Air Liquide Medical Systems. 8 YM033000 / Rev. 1.3 / 12-2012Q MannA_t¢ og Recommendations for the use of the CO; measurement probe PHASEIN IRMA™. + The IRMA mainstream multi-gas probe is intended to be connected to a patient circuit to monitor inspired/expired gases on adult or paediatric patients in intensive care, anaesthesia, and emergency treatment applications. + The probe must not be the only patient monitoring device. It must always be used with other devices that monitor vital signs and/or in addition to medical advice given by a qualified person. The IRMA probe may be used exclusively by qualified, authorised medical personnel. + RURba nenbereunhget bee! sem witisflaarBahle.asaesHaA¥ehe patient to another. Used adapters must be disposed of via the appropriate hospital waste disposal channels. * The IRMA probe must not be used with neonatal patients. + The measurements from the IRMA probe may deteriorate in the presence of devices emitting electromagnetic interference exceeding the levels of the 60601-1-2 standard. Ensure that the probe is used in an appropriate environment. * Only adapters manufactured by PHASEIN may be used with the IRMA probe. + Use only IRMA probes sold by Air Liquide Medical Systems, Cat. No.: KB020400 * Do not connect the IRMA probe at the output of a steep bend, to avoid the accumulation of patient secretions in the adapter, and the obstruction of the BLUEYE ™ windows. al al + When using the IRMA probe, place the adapter so that its BLUEYE™ windows are vertical so that patient secretions do not accumulate on the windows: + When using the IRMA probe, place the adapter so that moisture and secretions do not accumulate in it due to the action of gravity. + Do notuse any sprayed medication with the IRMA probe, because the spray might affect IR transmission through the windows of the adapter. Never sterilize the IRMA probe or immerse it in liquid. Do not pull on the cable of the IRMA probe Do not use the IRMA probe at a temperature below 10°C or above 40°C. When using the IRMA probe, be sure to connect it to the machine before connecting itto the patient. o YM033000 / Rev. 1.3 / 12-2012 9QmonnaT¢0 REGULATORY REQUIREMENTS Directives Directive 93/42/EEC of the Council of 13 June 1993 concerning medical devices. Directive 2002/96/EC of the European Parliament and the Council of 27 January 2003 concerning waste electrical and electronic equipment (WEEE) Standards The compliance of Monnal T60 with the essential requirements of Directive 93/42 is based on the following standards: NF EN ISO 14971:2001 and A1:2003 | Application of risk management to medical devices IEC 60601-1:2000 and appendices | Electromedical Devices — Part One: General Safety Rules IEC 60601-1-2:2007 | Electromedical Devices - Part 1-2: General Safety Rules — Collateral Standard: Electromagnetic Compatibility — Requirements and Tests IEC 60601-2-12:2001 | Electromedical Devices - Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators NF EN 794-3:1998, A1:2005 A2: 2009 | Lung ventilators: - Part 3: Particular requirements for emergency and transport ventilators. NF EN 1789: 2010 section 6.3 requirements for medical equipment | Medical transportation vehicles and their equipment. EN 13718-1: 2008: Part 1: Requirements for medical devices used in air ambulances Disposal of components Waste disposal method: All waste generated by the use of this respirator (patient circuit, bacteriological filters, etc.) must be disposed of via the appropriate hospital waste disposal channels. Device disposal method: In accordance with Directive 2002/96/EC dated 27 January 2003 concerning Waste Electrical and Electronic Equipment: ‘Waste from electrical and electronic equipment must be disposed of via appropriate channels. Refer to the general conditions of sale of this device for its disposal procedures." Disposal of batteries, internal battery, and O2 sensor: TRBLEPLI RPA BEAN AL RAURIHE Rs "echargeable batteries, and O sensors must be 10 ‘YMO033000 / Rev. 1.3 / 12-2012Q mMonnateg Shipping the equipment If shipping the equipment, always use its original packaging. If the original packaging is unavailable, contact your Air Liquide Medical Systems representative to obtain replacement packaging. ‘YM033000 / Rev. 1.3 / 12-2012 "1Q MONNAL TE 9 1. DESCRIPTION OF OPERATION Monnal T60 is a standalone ventilator using air (propelled by a blower) used to treat children (7 kg* and above) and adults. It is not intended for neonatal ventilation. Itis intended to be operated by hospital personnel (physicians, nurses, etc.) and is used: - For transportation inside hospitals, For primary and secondary transportation, - In Intensive Care Units, - and in post-operative recovery rooms. Itis also intended to operate with various components, such as: - ACO2 measurement probe - AHEPA filter - Ahumidifier - Oxygen from a network, cylinder, or concentrator. 1.1. EXTERIOR DESCRIPTION 1.1.1. FRONT VIEW 1. Handle 2. Touch screen (8.4-inch) 3. Alarm indicator lights 4. Rotating knob 5. AC power supply operation indicator 6. Internal battery operation indicator 7. Interchangeable battery operation indicator 1 * 6 kg and above for software version v1.0.2, 12 YM033000 / Rev. 1.3 / 12-2012Q MOnnAL_Té HANDLE SIDE 8. Emergency air inlet 9. Loudspeaker 10. VGA video port 11. USB port 12. USB port Foor sipE 13. Electrical connection with the hot wire expiratory flow sensor (expiratory assembly removed) 14, Feet ‘YM033000 / Rev. 1.3 / 12-2012 13,Q MONNALT¢ 1.1.2. RIGHT-HAND SIDE:PATIENT INTERFACE 15. Cooling vent 16. Port for exhaled patient gas / electrical connection to hot wire flow sensor 17. Expiratory circuit connection 18. IRMA CO; probe connection socket 19. Inspiratory circuit connection 20. Expiratory valve eject button 1.1.3. LEFT-HAND SIDE:FLUID INTERFACE 21. ON/OFF button 22. Electrical power supply connector 23. Pull-out protection device 24. High-pressure Oz inlet 25. Cooling vent 26. Interchangeable battery housing 27. Low-pressure O> inlet 28. Micro blower unit input 14 ‘YM033000 / Rev. 1.3 / 12-2012Q monnateo 1.1.4. VIEW FROM BELOW 29. FiO2 cell 30. Docking station electrical connections 31. Manufacturer label YM033000 / Rev. 1.3 / 12-2012 15Q MONNALT EG To 1.2. PRINCIPLE OF OPERATION perform its essential functions, the device brings together four sub-systems: Electronic sub-system: this supplies the energy needed to power all electrical components and runs the overall system (sending instructions to actuators, taking measurements, etc.). Pneumatic sub-system: this performs the essential function of the device, i.e. ventilating the patient. Mechanical sub-system: ensures a robust link between all the components, and provides the user with an interface combining qualities of design and ergonomics. Software sub-system: this is the system's intelligence. 1.3. FUNCTIONAL DESCRIPTION 1.3.1. FUNCTION FLOWCHARTS General flowchart Inhaled air Exhaled air ‘YM033000 / Rev. 1.3 / 12-2012Q MONNALTEg Detailed flowchart 1.3.2. ELECTRONIC SUB-SYSTEM The electronics can be broken down into main functions: - The microprocessor board, which orchestrates the operation of all system elements (actuators, meters, interface, etc.). - The power unit, which transforms and supplies the energy required for the proper operation of the ventilation board. - The visual interface, comprising a graphic display, a touch screen and visual indicators. ‘YM033000 / Rev. 1.3 / 12-2012 7Qi IINAL-TE9 THE MICROPROCESSOR BOARD Buzzer Microprocessor board Power supply board Processors The ventilation board comprises two identical Motorola CPUs: - Ventilator: this sub-system is the processor dedicated to ventilation. It integrates the electronic conditioning stages linked to the sensors (flow, pressure, etc.), to the controls for the electro-pneumatic elements (blower, SV. etc.), to the audible alarm (buzzer) and to the communication with the monitor. - The monitor: this sub-system is the processor dedicated to the MMI (man-machine interface). It allows for full management (cf. display interface), integrates the electronic stages linked to safety and to redundancy of commands for particular elements (audible and visual alarms, pressure metering, etc.) and handles the communications with the ventilator. 18 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 9 THE POWER ASSEMBLY The power card provides the energy to the ventilation board and to all the pneumatic actuators. This power may be provided from multiple sources: - The mains via an AC/DC adapter 2 MRGRDUEFE URRY GEREPIBERAlPBLttery - An ‘interchangeable’ internal battery. The power board handles automatic switching between these different power sources and informs the microprocessor board of the sources present. In the absence of an electrical network, the power supply module will automatically switch to the interchangeable battery and then, if necessary, to the internal battery if the interchangeable battery is absent or its charge is too low. ‘YM033000 / Rev. 1.3 / 12-2012 19Q monnat_teg THE DISPLAY INTERFACE The screen on the MONNAL T60 comprises an 8.4” TFT colour display equipped with LED back-lighting. These LEDs are powered by a 26 V voltage from the power supply. The user interface is provided by means of a 5-wire resistive 8.4" touch screen and its controller. The controller transforms the screen position of the user's finger into Cartesian coordinates (x, y). The system for adjusting and validating parameters is handled by a coding dial (standard 16-position encoder). The front panel also contains the indicator lights for the system alarms (concerning ventilation or technical issues) as well as the presence of the various voltage sources and power supply status. Voltage sources Alarm indicators 20 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNAL TE 1.3.3. MECHANICAL SUB-SYSTEM The mechanical system comprises the combination of a chassis, which is the actual device mount, with face containing the MMI and patient-machine interface. Cnassis BRSURRAS icles ELEY it Sind oSHSHG aS MAiSHRe Of the mechanical and Chassis Micro blower unit Pneumatic unit Battery interchangeable ‘YM033000 / Rev. 1.3 / 12-2012 2Q MONA T¢ 9 MICRO BLOWER UNIT: This assembly consists of a case containing a blower. PNEUMATIC UNIT ASSEMBLY: This assembly is the main pneumatic unit, comprising the inspiratory and expiratory branch. It includes: * The inspiratory flow sensor: Thismeneeduennsistnefshaserenand the received from the sensor. © The patient and atmospheric low-pressure sensors # One proportional and one on-off PEEP solenoid valve © A patient insufflated gas temperature monitoring probe * An oxygen cell. Two non-return valves, of which one acts as the backup air inlet 22 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 9 PEEP Proportional SV ON/OFF SV Pressure sensors Flow sensor BATTERY HOUSINGS: These housings are used to insert the internal battery, secure it mechanically, and receive the interchangeable battery. MIXER UNIT ASSEMBLY: This is the low- and high-pressure oxygen inlet of the machine. It is equipped with two non- return valves, an oxygen pressure sensor, a proportional solenoid valve, and a flow sensor used to adjust it to obtain the desired gas mixture. This unit is connected to the micro blower unit via a polyurethane hose. The air-oxygen mixture is created inside the micro blower unit. INTERCONNECTION BOARD: This board is used to connect all the actuators, sensors, batteries, and the cooling fan. ‘YM033000 / Rev. 1.3 / 12-2012 23Q MONNALT 69 THE PATIENT-MACHINE INTERFACE The patient-machine interface on the right-hand side of the device includes the inspiratory branch fitting, the expiratory valve assembly reception area, and the etCO2 probe connection. 24 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 9 FRONT PANEL The front panel is the upper part of the external casing of the device. It incorporates the entire human-machine interface, including the display screen, the 8.4-inch touch screen, the microprocessor/power board, the rotary knob, and the indicators associated with the system alarms and AC power supply presence. ‘YM033000 / Rev. 1.3 / 12-2012 25Q MONNAL TE 1.3.4, PNEUMATIC SUB-SYSTEM PNEUMATIC SYSTEM im AB wo em pn eS OX TT vit ee 2 gy OG, agi x e077 TRIKE * woke a w = + vant are_| ” 7 oe Ne xe aC Key AIR Ambient air inlet PATIENT Patient O,BP Lowpressure 02 inlet (concentrator) BALLOON —_Expirary valve equipped wih a membrane OHP High-pressure 02 inlet (network, cyinder) C1 Nonretum vate Pst ‘Airway inspiratory pressure sensor C2 Nonretum vale Ps2 ‘eway inspiratory pressure sensor (fedundancy) C3 Nonretum vale APS3 Atmospheric pressure sensor C4 Nonretumn vane ps4 zpressure sensor F1_Oplnet ter (Cxconcontator) T Micro blower unt F2 —Airntake fiter (HEPA titer Ts Patent gos temperature sensor F3_Ovintakefiter (compressed gas) vt ‘Oxygen regulating proportional solenoid valve F4 Bronze iter (low attenuation) v2 Proportional PEEP adjustment solenoid valve FS1__ Patient fow sensor v3 Ont pause solenoid valve FS2 Hotwire exrratoryfow sensor RI Calrated once FS3__ Osflow sensor os Oxngen sensor 26 ‘YM033000 / Rev. 1.3 / 12-2012Qmor mALTEo 1.4. PNEUMATIC OPERATION 1.4.1. — OPERATION OF VENTILATION The micro blower unit (T) of the ventilator takes in ambient air via the HEPA filter (F2) and ensures sufficient compression according to the patient and the settings concerned. The compressed gas is then distributed via a pneumatic network according to whether an inspiratory or expiratory phase is being delivered. - INSPIRATORY PHASE The main component during the inspiratory phase is the micro blower unit (T) which regulates the flow via the flow sensor (FS1) when volume-controlled mode is selected, or via the pressure sensor (PS1) during pressure-controlled mode. At the same time, solenoid valves (V3) and (V2) are open and closed, respectively, so that the pressure of the micro blower unit is applied to the membrane (M1) of the expiratory valve, thus forcing the air sent by the micro blower (T) towards the patient only. - EXPIRATORY PHASE In this phase, the patient expires the gases inspired in the previous phase, and the device is asked to regulate at a pressure level determined by the settings (PEEP). With this in mind, the PEEP regulating proportignal solenoid valve (V2) regulates the expiration pressure via the pressure Sensor (PS). Meanwhile, the micro blower unit (T) regulates the flow rate via the flow sensor (FS1) to a rinse flow of 5 Limin. This limits reinhalation and ensures fast detection of an inspiratory demand. fl During leakage ventilation , NIV type, the micro blower unit (7) is likely to increase the rinse flow rate: it then switches to an ‘on-demand valve’ mode. The aim of this function is to compensate for leaks to maintain the PEEP in the circuit. - AIR/ O2 MIXTURE The O2 concentration of the gases administered to the patient depends on the source RRRNSRESELIAAAR devicrcA diiatipction is in fact drawn between operation with an O2 ~ OPERATION ON AN O2NETWORK To be able to operate correctly, the pressure at the O; intake terminals (02 HP) must be between 2.8 and 6 bars. The O; is then filtered via F3. The proportional solenoid valve (V1) provides oxygen enrichment to the mixture by regulating the flow rate (FS3), with the set-point being proportional to the upstream flow rate (FS1) and according to the FiO» rate setting. ‘YM033000 / Rev. 1.3 / 12-2012 27Q manna_teo ‘EX Operation at a network pressure between 1.5 and 2.8 bar, or between 6 and 7 baris possible, but the quality of the enrichment could then be altered. If the pressure falls below 1.5 bar or rises above 7 bar, the oxygen supply is then cut off by the proportional solenoid valve (V1) and an oxygen supply error alarm is triggered, « OPERATION ON A CONCENTRATOR The device is equipped with a ‘low pressure’ connector to operate with a concentrator Aigatrastie den Einhinee atinnip spel anerien WRMnpre see @SenRe he VARA At continuously delivers a mixture at the correct FiO. However, the concentration of the mixture might not be reached, because it depends: - On the type of concentrator and its settings (the 02 flow rate delivered by the concentrator is often low, and its O2 concentration is variable, between 90 and 100%) - Ventilation parameters Below are the maximum concentrations that can be obtained with different concentrator flow rates (assuming their 02 concentration is 100%) according to the volume per minute of a patient ventilated at a frequency of 15 bpm. F102 (%) 00 ° 5 0 5 2 3 Volume per minute (Limin) For example, for a concentrator delivering 5 L/min and a patient ventilated in volume- controlled mode with a Vt of 0.6 L and a frequency of 15 bpm (i.e. a volume per minute of 0.5x15=7.5 Limin), the maximum obtainable concentration will be approximately 50%. The device will then be able to deliver any concentration requested below that value. 28 YM033000 / Rev. 1.3 / 12-2012Q MONNAL TE 9 "FA Because the device consumes only the flow rate it needs to provide a mixture of the correct concentration, Air Liquide Medical Systems recommends selting the low-pressure source to its maximum flow rate. This will make it possible to obtain a wider range of possible FiO2 values. Whatever the function mode for the device, the oxygen sensor (0;S) ensures monitoring of the concentration in the circuit. This sensor is a chemical cell that carries out an electrolytic reaction. The current produced is, proportional to the partial pressure of oxygen, however. a compensation of this pressure is applied FAL rato a OReen ets Alt BHIebed. AeIbIenl ayowtty eualary At URaR ear characteristics - Measured parameters). YM033000 / Rev. 1.3 / 12-2012 29Q MONNAL TE 9 1.5. ELECTRICAL POWER SOURCES This respirator is compatible with various electrical power supply sources: = AC power supply via the ac power supply box supplied with the device = Power supply on an external DC source = Power supply on two internal DC sources (internal battery and interchangeable battery) The electrical characteristics of each source are described in Chapter VIII.4.1 (Electrical specifications). fA Ir the device has stopped suddenly during ventilation (at the end of battery life, for example), it relaunches ventilation directly using the last parameters saved when the device is reconnected to the mains and started up again. 1.5.1. POWER SUPPLY MANAGEMENT The power supply board manages the automatic switching of energy sources according to the following hierarchy: = AC power supply or external DC source = If absent: by interchangeable battery = If absent: by internal battery ACPOWER SUPPLY The presence or absence of the AC power supply or the external DC voltage source is indicated by two pictograms. 7 ac power supply presence ABE Ac power supply absence This is also indicated by a blue LED on the front panel of the device. INTERCHANGEABLE BATTERY AND INTERNAL BATTERY The respirator is equipped with two batteries: an intemal battery, ‘INT’, which is not accessible to the user, and an interchangeable battery, ‘EXT’, which can be replaced during operation. In the event of absence of the AC power supply or the extemal DC voltage source, switching over to the interchangeable battery takes priority. When the interchangeable battery is fully discharged or absent, the device automatically switches over to the internal battery. The internal and removable batteries have the same capacity. The charge status of both batteries is indicated in the upper left-hand part of the screen: (ON Full battery charge 30 ‘YM033000 / Rev. 1.3 / 12.2012Q MONNAL-T¢ 9 High battery charge Medium battery charge Battery low: reconnect the device to the AC power supply For the internal battery, the pictogram is associated with a medium- priority acknowledgeable alarm: ‘Internal battery low'". Battery dangerously low — imminent shutdown For the internal battery, the pictogram is associated with a medium- fmm Priity acknowledgeable alarm: ‘intemal battery ow! Connect to mains’ and then ‘internal battery inoperative!!! Connect to mains’. Itis then urgent to connect the respirator to the mains (AC power supply) or to replace the interchangeable battery to prevent it from shutting down due to a lack of power. When the unit is connected to the mains or an external battery, the unit's internal battery recharges. When intemal battery charging is complete, the machine charges the interchangeable battery, if any. A special pictogram appears on the screen, representing the progress of light segments: (ERs Battery discharged [JMR Battery half-charged Bd io iB TIT] Battery fully charged W In the event of operation at a high or very low ambient temperature, a safety device might interrupt the battery charge. An ‘excessive battery temperature’ alarm is triggered. This can have a significant effect on the charging time and operating duration of the battery fl The charging time per battery is approximately 2 hours 20 min (at 25°C ambient). When the machine is switched off but connected to the mains or an extemal DC power source, batteries are automatically recharged . If the unit cannot recharge the battery because the battery is absent or defective, the following pictogram appears on screen: Battery unavailable THEE For the intemal battery, the pictogram is associated with a high-priority alarm, ‘Internal battery unavailable! Check the battery’. Z\ The batteries must not come into contact with water, as this could damage the batteries or injure the user. ‘YM033000 / Rev. 1.3 / 12-2012 31Q MOnna_te ag 1.6. DESCRIPTION OF THE PNEUMATIC COMPONENTS 1.6.1. MICRO BLOWER UNIT (T) Airintake Mixture outlet Oxygen inlet ROLE It pressurises the patient gas. OPERATION The motor power supply is 26 V. The motor has a three-phase power supply with amplitude PWM (Pulse Width Modulation). It can supply pressures up to 100 mbar and rotate up to 70,000 rpm. A servo-system monitored by a Hall Effect sensor is used to control the speed of the micro blower unit. W The performance of the micro blower unit is influenced by atmospheric pressure, and thus by altitude (the density of the gases is lower at altitude). 32 YM033000 / Rev. 1.3 / 12-2012Q MONNAL_T¢ 9 1.6.2. MIXER UNIT 02 HP To micro blower unit 02 BP ROLE The proportional solenoid valve (V1) associated with the flow sensor (FS3) enriches the mixture with oxygen. For FO > 21%: Qo2=Qrnisture X (F'O2-0.21) 0.79 OPERATION V1 closed at rest. V1 is controlled by a signal with the following characteristics: - Amplitude PWM: 0 - 12V; - PWM: 20 kHz. YM033000 / Rev. 1.3 / 12-2012 33Q MONNAL_T¢ 9 1.6.3. EXPIRATORY VALVE ROLE The function of the expiratory valve is to pressurise at patient level during the inspiratory phase and to control the patient's expiration. ~ OPERATION Bules.sanisationndtis valve is open to a greater or lesser degree to control the PEEP level The expiratory valve comprises a membrane, to which a pressure is applied such as to vary the size of the opening through which the expired gases pass. Membrane control pressure Membrane H| Membrane wae | aR Outletfor = += Outletfor <= | exhaled gases ' exhaled gases ' | Patient pressure Patient pressure EXPIRATION wio PEEP EXPIRATION with PEEP During insufflation, this valve is closed (micro blower unit pressure applied to the membrane). 34 YM033000 / Rev. 1.3 / 12-2012Q MONNAL-TE9 Membrane control pressure i INSUFFLATION | —! | Patient pressure | Membrane Fl By design, the expiratory valve features a non-return flap to prevent re-inhalation of expired gases. Fl The autociavable expiratory valve tolerates 50 sterilisation cycles. A unit serial number on the body of the valve advises the date of manufacture of the elements, and if necessary makes it possible to track the number of cycles gone through. YM033000 / Rev. 1.3 / 12-2012 35Q mannate ag 1.6.4. HOT WIRE EXPIRATORY FLOW SENSOR (FS2) ROLE This sensor measures the gas passing through the expiratory branch of the patient circuit. The measurement makes it possible to: — Display the expired flow: — Monitor the ventilation rate per minute. OPERATION The sensor comprises a resistance wire placed in the flow, and passed through by a current at a constant level which increases the temperature of the wire in a continuous manner. The result of this is a convection heat exchange between the wire and the flow of gas, and the resulting temperature of the wire is indicative of the speed of the flow. Range: From 0.5 to 200 L/min. Accuracy: + 15 %. During automatic tests of the device, the hot wire expiratory flow sensor is calibrated. During ventilation, the zero is periodically recalibrated (every 2 minutes). 1.6.5. MASS FLOW SENSOR (FS1AND FS3) ROLE This sensor is used to measure the inspiratory flow rate and to regulate the mixture. OPERATION The sensor measures heat transfer between a point A and a point B situated on one side and the other of a heating element. The temperature difference is proportional to the mass flow. A__Heatingelement —_B. Tai a Toi {ome = i : —* Noflow Temperature <> varia Operating range: 0 to 200 Limin (voltage from 1 to 5 V). 36 ‘YM033000 / Rev. 1.3 / 12-2012Q MONNAL TE Calibration: — zero: during automatic tests; — gain: in the factory, or in maintenance, 13 points. @ The operation of the mass flow sensor is affected by atmospheric pressure. The atmospheric pressure sensor (APS3) adjusts the value measured by mass fiow sensors FS accordingly. 1.6.6. PRESSURE SENSORS - LOW-PRESSURE SENSORS ROLE Differential pressure sensor (PS1, PS2): gives access to the turbine pressure and checks that the pressure is properly regulated in the patient's airways. Absolute pressure sensor (APS3): measures the atmospheric pressure. OPERATION Pressure sensors PS1, PS2, and APS3 are piezoelectric. SSN CISC cay polenSed Then SLbjecteG To meduaieal Stresses, He uBR oF electrical charges produced is proportional ‘over a wide range to the pressure exerted. This type of pressure sensor has a very short response time. PS1 and PS2 are differential pressure sensors, i.e. they measure the difference between a given pressure value and a reference pressure (in this case, atmospheric pressure). APS3 is an absolute pressure sensor; it measures the pressure above absolute zero. YM033000 / Rev. 1.3 / 12-2012 37Qe manna OXYGEN PRESSURE SENSORS (PS4) Ps4— Q ROLE Op pressure sensor (PS1): detects the presence or absence of the oxygen feed supply. OPERATION The pressure sensor is piezoelectric. It operation is identical to that of sensors PS1, PS2, and APS3. It is also differential. 1.6.7. F\O2 CELL (02S) ROLE The FiO, cell is an electrochemical sensor placed in the inspiratory branch It measures the percentage of Oz in the air/oxygen mixture. OPERATION This sensor performs an electrolytic reaction. The current produced is proportional to the partial pressure of oxygen; however, a compensation of this pressure is realised each time the automatic tests are launched. Calibration is automatic during the automatic tests, and is made to 21%. Range: from 21 % to 100%. Relative accuracy: + 3 %. FA By virtue of its engineering, the lifetime of the FiO2 cell depends on the ventilator's consumption of O2. The operation of the F\Oz cell is affected by the pressure (atmospheric pressure and circuit pressure). In order to mitigate this effect, software compensation is applied, taking the pressure sensor measurements into account. A 10% drift in the voltage in the cell is observed for each additional 1000 metres in altitude. For example, for a cell with a voltage of 15 mV at sea level, the voltage will fall to 13.5 mV at 1000 metres altitude. The ambient temperature and the patient gases affect the oxygen measurement. Electronic compensation is applied via the temperature of the patient gases. Ambient humidity similarly influences the measurement of oxygen, at a rate of -0.03% per %Hr at 25°C. 38 YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 1.6.8. TEMPERATURE SENSOR (TS) ROLE ° This sensor monitors the temperature of the gases delivered J It provides temperature compensation for the 02 cell. y / OPERATION The output voltage from the temperature sensor is linearly proportional to the temperature in degrees Celsius (+ 10.0 mv/°C). Range: -55°C to +150°C ‘Accuracy: 0.5°C (at 25°C) ‘YM033000 / Rev. 1.3 / 12-2012 39Q MONNALT¢g 1.7. DESCRIPTION OF CIRCUITS 1.7.1. PNEUMATIC CIRCUITS 1.7.2, ELECTRICAL WIRING INTERCONNECTION BOARD 40 YM033000 / Rev. 1.3 / 12-2012Q monnatteo ELECTRONIC ASSEMBLY ‘YM033000 / Rev. 1.3 / 12-2012 aQ MONNALTE9 2. EQUIPMENT REQUIRED FOR MAINTENANCE STANDARD TOOLKIT Type of device External | manometer, 0-5 bar, Class 1 measure “manometer, 0-100 mbar, Class 1 ment Atmospheric pressure gauge station Flow sensor, 0-200 Limin External oxymeter OR 7 Digital voltmeter T fiting for pressure connector and appropriate silicone hose 02 power supply hose with pressure connector PC (with HyperTerminal link) 2GB USB key, Cat. No. YR112900 USB 2.0 cable A (male) - B (male) Antistatic apron SPECIAL TOOLKIT Type of device ee Test lung vs206103 Q, connector removal spanner ‘YA000700 BM connector removal spanner YA004400 Extension ribbon YR122700 Blower inlet cap YA018100 a Software ansuaex xxx Software Update Type of maintenance Preventive ,GeKteRtikee x xxx x x KK KKK Type of maintenance Preventive x Corrective maintenance x sim. "PRR BE Gt SNA SPARE CDSG PUA SHO BACEAG HIM teh esigAbahr 0-100 mbar, atmospheric pressure), flow meter 0-200L/min, and oxygen meter - making it possible to measure the following ventilation parameters: F, VE, VTi, VTe, PEEP, PSV. W Rotameter-type flow sensors are sensitive to altitude. Air Liquide Medical Systems advises against their use and recommends the use of pressure-compensated flow sensors. 42 'YM033000 / Rev. 1.3 / 12-2012Q mMonna_t¢g 3. ACCESS TO THE MAINTENANCE MENU The maintenance menu requires special skills confirmed by a maintenance training course, because it can be used to modify certain critical settings, such as Start-up configuration of the device, language, serial number (if the microprocessor board is replaced), enabling of options. Refuses eovereigeaearadiration page on the touch screen. Access is therefore controlled by the enabling of a code whose validity period is variable (from 1 month to 3 years), or unlimited, according to the maintenance management mode chosen. To access the maintenance screen, power up the MONNAL T60. The stand-by screen appears. Press the knob and the centre of the touch screen simultaneously. The following window appears when the MONNAL T60 is outside the validity period or the first time you seek access: Enter the appropriate code and access the following window: -YM033000 / Rev. 1.3 / 12-2012 434. SOFTWARE UPDATE The procedure for updating the Monnal T60 software is supplied with every new software version. Refer to the technical note accompanying the software version. A software update is simple, and requires only a few steps. This procedure describes how to update the ventilator and monitor. 4.4, ACCESSING THE UPDATE SCREEN In the stand-by séreén, press and hold the adjustment knob and touch the centre of the screen; a new Configuration window appears. Select ‘Update’ to update the VENTILATOR and MONITOR. 44 -YM033000 / Rev. 1.3 / 12-2012Q MONNAL TE The downloading screen appears. 4,2. CONNECTION Connect the PC to the MONNAL T60 using a USB-A male to USB-B male cable. 4.3. PREPARING THE PC 417g Gfstgigng you connect the PC, install the ALMS Maintenance Utilty (Flashouilleur’) V. ry Pht 6.00 This utility is provided on request to any authorised person. - Open the file, select the ‘update’ tab (normally selected by default). -Press ‘detect devices’ After a search phase, the utllty should detect the two microprocessors to flash. If it detects nothing, check the connection and repeat the procedure. -YM033000 / Rev. 1.3 / 12-2012 45Q MONNAL TE 4.4. DOWNLOADING The firmware consists of two binary files (.bin) Monitor (M) and Ventilator (V). Select the ventilator upgrade binary file: QALMS Maintenance utility 1.3.1 arenes | No stan in progress, (00:00 - Speed: 0 B/s [ieegnecray SS) _ The file location should now appear in the maintenance utility window: 46 -YM033000 / Rev. 1.3 / 12-2012'YM033000 / Rev. 1.3 / 12-2012 47Q MOnna_t¢ og The file location should now appear in the maintenance utility window: | FNS ie Lue ALE eae Usdste | Dovminad blackboxes | Download white boxes Ventilator Frmware FLIMTEO/Femwareioekbin Morir firmware ‘No scanin progress Ventilator Firmirare FMTEO/Femmarejosiotbin MoritorFiroware: FrINT6o/FImmarsiosiot. bin No sean in prowess 1° DS une n ues ae Uéste_Dovmibedbackbaxes | Download wie boxes Ventilator rmare FrINTEO/FIrmmarsjosivtbin Moritor Fim are FrIMT6O/Fermarelostol. bin Scan serial devices Start update CL | Speed: 2281 Bs 48 -YM033000 / Rev. 1.3 / 12-2012Q MONNALT¢ 9 When the software unlocks, the transfer is complete. If the progress bar has not reached 100%, the transfer has failed. Wait one minute and then repeat the procedure. 4.5. CHECKING THE DOWNLOADING After updating the VENTILATOR and MONITOR, the machine reboots. When all the software programs are up to date, check that the software version number appears at the bottom of the alarm panel (only one version number). Select New patient, Adult and run an automatic test. Start ventilation and ensure that there are no technical alarms (it may be necessary to restart the ventilator to clear the technical alarms). When the procedure has been successfully completed, the ventilator may be returned to service. Complete the tracking sheet included in the technical note, and return it to Air Liquide Medical Systems. -YM033000 / Rev. 1.3 / 12-2012. 49QmMonnat_Téo 5. DOWNLOADING THE BLACK BOX This procedure describes how to download the MONNAL T60 black box. The black box can be downloaded in two ways: via a USB cable, or directly using a USB key. The access method depends on the solution chosen. 41. BLACK BOX DOWNLOADING PROCEDURE VIA USB KEY In Stand-by Mode, insert the USB key directly into the appropriate port. The following screen appears: MONNAL T60 then looks for the space available on the key. Wait while it does this. When the space available on the key is displayed, press the ‘Black box’ key. The transfer takes place. When downloading is complete, remove the key. The MONNAL T60 returns to stand-by mode. A directory called MT60 has been created. It contains a sub-directory called 00xxx, which is the Serial Number of the device. Send MT60 to Air Liquide Medical Systems. 5.2. HARDWARE CONFIGURATION VIA USBCABLE Connect the PC to the MONNAL T60 using the USB-A male to USB-B male cable. Use the same physical port on the PC that is used for software downloading. Mee ==-s) QO -YM033000 / Rev. 1.3 / 12-2012.QmoannatTeo 5.3. ACCESSING THE DOWNLOAD SCREEN From the stand-by screen, access Maintenance Mode, and then press Transfer boxes followed by Black box. 4. BLACK BOX DOWNLOADING PROCEDURE Open the maintenance utility. Select the medical device concerned (in this case, MT60) from the ‘download black boxes' tab. © Monnal 40/150 @ Monnal 760 © Monnal 175 © Feb 1k © FebxSsk © tend No scaninprogess Devnload Back boxes Click ‘save as...’ to select the location to which you wish the file to be downloaded. Give it a name in the format BN_MT60_SNxxx.. his. (SNxxx is the serial number of the device.) Activate ‘download black boxes’ to begin the transfer. -YM033000 / Rev. 1.3/ 12-2012. 64© monnalr49/750 @ MonnalTéo © Monnalt75_© Fetish _© Fede sek The progress of the transfer is indicated throughout the process. The software is. locked and cannot be stopped in the normal way. In the location where the file has been downloaded, rename it in the format. BN_MT60_SNXxx.. his. (SNxxx is the serial number of the device.) N-NTE0-049.HIS Fichier HIS 48Ko Send it to Air Liquide Medical Systems. 5D -YM033000 / Rey 13/19-2012,Qmoannat_Teo 6. DOWNLOADING THE WHITE BOX This section gives the procedure for downloading the MONNAL T60 white box in the event ofa technical problem. The white box restores the specific ventilation signals before and after the occurrence of apigadeRhnical problems, to supplement the black box data and optimize the maintenance alarm tracked by the black box. E tis important to follow the steps described in this section. 6.1. HARDWARE CONFIGURATION Connect the PC to the MONNAL T60 using the USB-A male to USB-B male cable. Use the same physical port on the PC that is used for software downloading. 6.2. ACCESSING THE DOWNLOAD SCREEN From the Stand-by screen, access Maintenance Mode (see Section 3 for activation of the, maintenance access code, if necessary) and then press Transfer boxes followed bywWhite box. ‘yaanaannn | Rev 42/19-9019 _Q monna_teo 6.3. WHITE BOX DOWNLOADING PROCEDURE Open the maintenance utility. Select the medical device concerned (in this case, MT60) from the ‘download white boxes’ tab. peeesalee nascar m rozess OOOO OO) -Select ‘save as...’ to select a location for the downloaded file. Give it a name in the format BB_MT60_SNXxx .x1s. (SNxxx is the serial number of the device.) -Launch the download by pressing ‘download white boxes’. eee © end 107150 © Mennsl 60 oscan nprogess The progress of the transfer is indicated throughout the process. After downloading, retrieve the file and send it to Air Liquide Medical Systems. fag} 2) Beerrccoze ae Feulle de cakul Merosaft ail | 1420 The final file size should be around 100 KB. i eaneannn Fes a a eeQML 166 Ww After downloading, press the button to delete the white box so that new data can be recorded there in the future. You may now quit the menu and return to the Stand-by screen. eee Pee _Q MONNAL_T¢ 9 7. ANNUAL PREVENTIVE MAINTENANCE 7.1. DEFINITION Preventive maintenance conducted annually. It consists of checking the operation of the device (see Section 9), and does not require the use of a maintenance kit. If the automatic test results and the ventilation performance are not satisfactory (compared to the expected data in the retum to service sheet, Section12), the device needs to be calibrated. (Refer to Section 10). This procedure takes about an hour and a half. The fixed internal and interchangeable batteries and the micro blower unit are subject to special handling. The batteries are dealt with by measuring the battery capacity. If the capacity is reduced by 60%, which is symptomatic of battery wear, a low-priority alarm message is displayed: ‘Internal battery defective’ or ‘Interchangeable battery defective’. The internal battery must be replaced as soon as possible. The user replaces the interchangeable battery. The ageing of the micro blower unit depends on several factors: speed, FiO2, ventilation time and temperature. Using an algorithm, MONNAL T60 is able to determine the rate of ageing, and generates a signal in the form of a low-priority alarm. Wear can also be indicated by an alarm such as ‘VTi or PI not reached’. Summary of preventive maintenance See Section 12 for the list of equipment required for maintenance. iodicity Annual Actions Electrical test x Calibration (see Section 9) optional Overall operating checks (see Section 9) xQ Manna te 7.2. FLOWCHART Check external condition, cleanliness of filters, expiratory No — Replace defective part(s) | Yes > Corrective Automatic tests maintenance and/or calibration Check ventilation and Electrical safety test Complete G6tuAte BePFice’ sheetQ MONNALTE 8. CORRECTIVE MAINTENANCE 8.1. FLOWCHART Corrective maintenance Automatic tests 7 Yes No Replace parts Calibration e = Calibration screen ©2or Insp flow > = 7 sensor i Calibration of both Checks of s sat flow sensors || operation z . a g Eloctrigaisatet Pressure sensor a 7 id é . wl 3 Complete the i 2 ‘return to service’ iE o sheet Microprocessor board». Complete calibration W when replacing one of the following intemal components on the MONNAL TE60: flow sensor, pressure sensor, solenoid valve unit, or microprocessor board, the corresponding calibration procedure must be performed, along with the operational check (Section 9) ZX During servicing, if there is any reason to suspect that part of the device might have been contaminated, the components concerned must be replaced.Qe MONNALT¢ 9 8.2. PROCEDURE FOR EMERGENCY SHUTDOWN If the ‘start’ button is no longer functioning, disconnect the internal battery and the mains power connection. Shutdown can be performed by the Start button in stand-by mode only if the software is operational. 8.3. ALARM MESSAGES The list of alarm messages is linked to the software version used. To see the alarm messages, refer to the user manual and the technical note providing updates according to the software version used. 8.4. DIAGNOSTIC AID LIST OF ALARMS The table below lists all the technical alarms programmed on the MONNAL T60, and for each message indicates the possible causes which might trigger the alarm and the actions to be initiated to rectify the problem. For each alarm, the actions to be implemented are listed in order of implementation. If the fault persists once the 1* item has been performed, move on to the next recommended ACHIRE.FAOK PRANSts despite checking all the points listed, please contact our technical department. ULTRA alarms are tracked by the white box. The white box downloading procedure is given in Section 4.STANDBY rede? Switching of f beaneh cteght be Device switched to Stand-by Mode Unit Off request Patient circuit obstructed, or RRGIBIERIMANEK, or electronic fault Triggering after cycles with high Press the knob to stop ventilation. Press ‘Cancel to leave ventilation running, Press the knob to switch off the unit. Press ‘Cancel’ to leave the unit on. Check the patient circutt Check the expiratory valve membrane Contact the technical department if the problem persists Expiration is prolonged for a maximum of 15 s, Until the measured PEEP returns below the PEEP setting. service!!! Use a service!!! Use a venti | ator!!! eryicel!! Use a Electronics failure 12V supply falls, below 10V 695 pas. Micro-biower ‘error: blower running above 36,000 rpm Pressure sensor power suppl Error, below /0V instead of 12V The error disappears automaticaly if the 12V returns to an acceptable level Replace the power supply boardimicro board assembly Run the automatic tests Maiealdd: HERE Bower is running too quickly, particulaly with exp branch blocked or in stand-by -> replace the power supply boardimicro board assembly. If the micro-blower unit does not start up: Replace it. -Run the automatic tests IfAlarm 4 is activated > (E#BALARE Mnnection of the sensors to the intercommunication board.RS Qmona Teg -Run the automatic tests Lebdton ter -Check the measurement Unit out of $8V'intemal ‘ame ehBhapbéars in service!!! Use a voltage threshold | Immediate itite waive (heastive. back- up below 13V. triggering ow dete TL venti | ator!!! Inspiratory flow < ) bei -lfthe sensor and valve are OK: replace the power supply/micro board assembly ‘Check the level of Paverk Inhibiton for 60. nese batt ele disconnection or Tort leak level too high, ‘Check the Adult/Child pe sconnectl os ‘r electronics patient setting. erate triggering within 17s, ‘Check the coherence of alarm levels with Fragered afer entiation settings High pressure! ! ventilation When the pressure sycles with a threshold Ie reached, the Pmax into machine goes into expiration mode. Error Error in dialogue detected! !! between the Connectivity Check the software vo Contact the ventilatormicro tests performed oO ver supa techni cal ‘and the monitor every second depart nent micro board assembly. | | ‘The error disappears Error automaticaly he 26V detected! !! retums to an acceptable +1 Contact the 26V failure 3s level. techni cal -Replace the power departrent ‘supply boardimicro board | “assembly. Error detected! !! : Contact the technical 12 Contact the Backlighting error / techni cal department. depart nent | ‘Activated when changing the software version; modify a ventilation Loss of ventilati 49 Settings settings lation | immediate parameter. i noper ati ve! triggering H,ep'siigiyentace the board/micro board assembly or its battery.ee eee Q MONNALT EG ‘Change the settings, qq Settings Incorrect alarm Immediate eT inoperative! !! settings triggering version. ‘Activated when changing the software version; modify an alarm ts. Alarmthreshol ds soe tem immediate threshold. inoperative!!! 9 ‘triggering Ifit persists: replace the power supply board/micro board assembly or its battery. Inhibition for 60 i son ventilation eae ew start-up ‘Check the coherence of 46 “Low VM!!!" a ‘atarrn| Triggering alarm levels with within 1 ventilation settings threshold ventilation Loyde. | Fito Or CO | Chock the level of Exhaled volume $2" Ver leakage WH per minute below Startup 17 Low Veet the alarm Triggering Check the coherence of threshold on alarmlevels with at ventilation settings Inhibition for 60 son ventilation Measured start-up. ‘Check the coherence of 18 Low frequency!!! frequency, a JHogered afler alarm levels with threshold ventilation _ Ventilation settings cycles with | min. ‘3cmH20 or 30% diference between P1 and P2* Launch automatic tests Error Calibrate detected! !! “Replace the following, in 19 Contact the Patient pressure | Immediate order. : techni cal sensor 182 error _ triggering Pressure sensor cable depart nent hamess Patient pressure sensor -Replace the power ‘supply boardimicro board “assembly. replete ‘Check that the unit is, gp Delivered gases gases delivered to Triggered within, Being used aecording to too hot the patient above 15s erect torent 60°C probe =rEN FIN. Ea ee QmMoMNALT Eo ‘Check the expiratory PEEP greater Measured PEEP valve membrane than PEEP set- atleast cmH20 Immediate 21 point +5 ‘greater than the triggering ‘Check the Evpep cnt!!! PEEP setting (Calloon) control Measured Peer Oro Check the coherence of frequency above $00 1 alarm levels with wp Hah the alam serseted after | Yenilation settings uy Frequency!!! automatic Seonsecutve | Reduce the sensitivity of triggering of the Yentiaton the inspiratory trigger if inspiratory trigger PCIE justified. Inhibition for 60 ‘Check the level of son ventiation aeons 23 High MII! borRRueeBG ve TAEBEFIng Check the coherence of the set threshold within 1 Seen ventilation —_ alarm levels wit cycle. ventilation settings Inhibition for 60 son ventilation Exhaled volume | start-up. ‘Check the coherence of 24 High vee!!! per minute above Triggering _— alarm levels with the set threshold within 4 ventilation settings ventilation cycle. Inhibition for 50 | Check the presence of sateach the oxygen supply. change of Fis Measured FiO? setting or ‘Check the coherence of 25 Soiowthe set Sha the alarm levels with threshold ventilation _ respect to the oxygen mode. supply installed. Triggering within 5s, Run the interactive tests. Inhibition for 50 sateach ‘Check the coherence of change of F102 the alarm levels with ‘9 respect to the oxygen change of change of supply installed. mode. Wiisarsg Run the interactive tests.TSU PE. Ta Tete Qmoma Teg “The sum of the Snictoe Batteries remaining charge 20 enpty!!! Connect in the two Pee [teen te rere, AC power BARRE RAIA, tothe mains. The sum of the ' remaining charge Connect a new 7 Gachared y inthe two Immediate _ interchangeable battery batteries is triggering cr connect the machine Connect “AC power between 10 and to the mains. 20% Error Replace internal battery detected! !! ae or interchangeable ov Contact the Thebatery | Tagerna tony othe power techni cal irger is faulty, within 10s ‘supply board/micro board depart nent assembly No patient T Apnea ao Apnea peeraratory actviy ‘Switch to back-up venti | ati on!!! atime greater immediate ventilation. than the set T apnea triggering Launch the automatic tests. Check the absolute Error pressure sensor * detected! !! ‘Atmospheric i Replace the following, in %4 Contact the pressure sensor Immediate order: techni cal ‘out of range. ‘triggering Pressure sensor cable depart rent harness. Absolute pressure sensor. Power supply boardimicro board assembly | Launch the automatic t88EEx the patientt pressure sensor * — Repleco the folowing in detected! !! Patientt pressure i : 28 Contact the sensor out of mediate Pressure sensor cable techni cal range. triggering mess ienartant patient pressure sensor. Power supply boardimicro board assembly Launch the automatic tests. Error ‘Check the patient2 a7 @ahestect he Eales 2arersure panera RESALE HETERO Wving, in techni cal triggering order depart rent Pressure sensor cable hamess patient2 pressure sensor.