Air Liquide MONNAL T60 ADVANCED User Manual Download Page 5

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Inputs and outputs...........................................................................................................................76

Video output....................................................................................................................................... 76
USB Connections................................................................................................................................76
Connectivity to hospital networks.................................................................................................... 77

Alarms and other messages..................................................................79

Maintenance..........................................................................................98

Accessories.........................................................................................101

List of options and accessories.................................................................................................... 101
Regulatory requirements................................................................................................................104

Maintenance........................................................................................105

By the user.....................................................................................................................................105
By the technician........................................................................................................................... 105
O

Cell............................................................................................................................................ 106

Technical description.......................................................................... 107

Operation........................................................................................................................................107

Pneumatic system........................................................................................................................... 107
Ventilation function..........................................................................................................................108
Air/O

mixture...................................................................................................................................108

CO2 monitoring................................................................................................................................ 110

Performance and characteristics.................................................................................................. 111

Recovery of the components of the medical device..................................................................... 136
Regulatory requirements................................................................................................................138

Appendix............................................................................................. 139

Checklist.........................................................................................................................................139
Maintenance data sheet................................................................................................................ 140

Summary of Contents for MONNAL T60 ADVANCED

Page 1: ...MONNAL T60 ADVANCED User Manual English Software Version V1 1 x www device airliquidehealthcare com YL180136 Revision 4 2021 03 V1 1 xI4 YL180136...

Page 2: ......

Page 3: ...ar panel 17 Installation and commissioning 18 Unpacking 18 Items included in the package 18 Installation on the wheel stand 19 Electrical power supply 20 Oxygen supply 20 Assembly of the patient circu...

Page 4: ...ction Hflow 47 ECLS function 49 CO2 option 51 Keeping alarm settings and thresholds 53 Displaying the curves 55 Monitoring 56 Measurements 61 Other functions 64 Menu 65 Menu structure 66 Sensors 66 Pa...

Page 5: ...ies 101 List of options and accessories 101 Regulatory requirements 104 Maintenance 105 By the user 105 By the technician 105 O2 Cell 106 Technical description 107 Operation 107 Pneumatic system 107 V...

Page 6: ...Expiratory assembly cleaning protocol 141 Monnal EVA autoclavable expiratory assembly 142 Monnal EVA single use expiratory assembly 142...

Page 7: ...patient interface e g mask or endotracheal tube which allows air to flow from the ventilator into the lungs It is for use by hospital personnel doctors nurses etc and is used in intensive care in pos...

Page 8: ...s training can be repeated or covered in more depth at the request of the users by contacting the usual Air Liquide Medical Systems representative Training in routine maintenance Training in the routi...

Page 9: ...the patient environment User position The human machine interface of the device faces the user so that the user can make the necessary adjustments with the control wheel and read the information disp...

Page 10: ...h or dinary waste channels It must re ceive appropriate end of life han dling in accordance with European Directive 2012 19 EU WEEE This device was manufactured after 13 08 05 USB connector Internal b...

Page 11: ...ust not be in operation near any incandescent source This ventilator must not be used with inflammable anesthetic agents or explosive products Do not use the equipment with helium or helium mixed with...

Page 12: ...ong periods with the battery it is recommended that an additional extractable battery is kept at hand Do not use antistatic or electrically conductive pipes The user must not touch the patient and the...

Page 13: ...ernal monitoring system It is nevertheless rec ommended in cases of complete patient dependence that you provide an additional fully au tonomous system which can be used to check the effectiveness of...

Page 14: ...e Monnal T60 Advanced system is not used in accordance with the user instructions of this manual The approved technician must use only Air Liquide Medical Systems spare parts when carrying out routine...

Page 15: ...sily 2 Touch screen 8 4 inches Interface between the user and the de vice Permits adjustment of all ventilation settings 3 Alarm indicators Illuminates to inform the user that an alarm has been activa...

Page 16: ...th the hot wire expiratory flow sensor expiratory assembly withdrawn 2 5 Right hand side Patient circuit connection panel 16 11 12 15 14 13 11 Cooling vent 12 IRMA CO2 probe connector socket 13 Inspir...

Page 17: ...OFF button 18 Electrical power supply connector 19 Anti pull cable protection clip 20 High pressure oxygen inlet 21 Cooling vent 22 Extractable battery housing 23 Low pressure oxygen inlet 24 Air inle...

Page 18: ...nt and before the first use of this device you must clean and disinfect the accessories see section Maintenance on page 105 3 2 Items included in the package 1 Monnal T60 Advanced ventilator including...

Page 19: ...4 and the oxygen cylinder 3 4 4 3 3 2 2 1 1 Note The articulated arm for the patient circuit is installed on one of the fastening points 2 System with wheel stand The Monnal T60 Advanced system and w...

Page 20: ...t let when stopping the machine Note The power cord enables Monnal T60 Advanced to be disconnected from the power supply on all poles simultaneously 3 5 Oxygen supply To use a mixture with more than 2...

Page 21: ...be placed on the Y shaped part 4 3 4 CAUTION Air Liquide Medical Systems recommends using the patient circuits listed in Chapter List of options and accessories on page 101 If not the use of patient...

Page 22: ...rs nebulizer etc are often available in a single use and an autoclavable version CAUTION Reusing single use accessories or consumables carries the risk of patient cross contamination This risk also ar...

Page 23: ...Pre use checks for each new patient 1 Connect the sensor to the patient adapter a A click should be heard when the sensor is properly connected to the adapter 2 Ensure that the etCO2 monitoring block...

Page 24: ...n resistance or block age CAUTION If a nebulizer is used it is necessary to use a filter on the expiratory limb to avoid damage to the expiratory flow sensor 3 9 Nebulizer CAUTION Y piece respiratory...

Page 25: ...nnot be guaranteed Note Air Liquide Medical Systems therefore recommends the running of these automatic tests before each use on a patient 1 To launch the automatic tests press the Automatic tests key...

Page 26: ...the touch screen and the control wheel CAUTION Avoid using any object that might scratch the screen 4 1 Ventilator display and controls This ventilator is controlled mainly via the touch screen and th...

Page 27: ...ion 8 Internal battery status 9 Extractable battery status 10 Selection of the category of the patient to be ventilated 11 Launch of the automatic tests 12 Quick mode launch By default quick launch of...

Page 28: ...s activated 6 Access to the measurements menu See Measurements menu on page 61 7 Automatic updating of the alarm thresholds See Automatic thresholds on page 58 8 Access to the other ventilation parame...

Page 29: ...ate a function press the corresponding button Press again to deactivate the function Ventilation settings Press the setting to adjust it The value is highlighted Turn the rotating knob to change the v...

Page 30: ...monitoring blocks are displayed on two pages Press to move from one page to another The key can be accessed when the device is locked Validation and information box This dialog box informs the user o...

Page 31: ...displays the predicted VT Weight coefficient in the help window for set ting the modes on the basis of volume It also displays VTe PBW exhaled volume predicted weight monitoring To specify the gender...

Page 32: ...nfant 3kg 20 75 Between 10 and 12 mm Note The user can only change the patient category via the start up or stand by screen Note If the Save patient settings functionality is enabled when the ventilat...

Page 33: ...n Starting ventilation 1 Define the patient category desired adult child or infant on the start screen see section New patient on page 31 2 Select the type of interface with the patient Invasive venti...

Page 34: ...alarm thresholds 3 Launch of the ventilation mode 4 Ventilation mode control 4 Adjust the parameters and alarm thresholds See Ventilation modes and functions on page 37 5 Press to launch ventilation T...

Page 35: ...2 Press the rotating knob to validate or press Cancel to continue ventilation After ventilation the machine stops ventilation and switches directly to the standby page Press to start ventilation with...

Page 36: ...asive Non invasive Optional A VCV X X A PCV X X PSV X X CPAP X X VSIMV X APRV X PS Pro X X PRVC X X PSIMV X X 4 5 Stopping the device 1 Press the ON OFF button left hand side of the machine 2 Press th...

Page 37: ...AUTION For safety reasons apnea ventilation should only be deactivated when the clinical situation so permits Air Liquide Medical Systems recommends activating apnea ventilation Note Ideally the apnea...

Page 38: ...etting the lower limit on the frequency and tidal volume according to each patient category 4 6 3 A PCV controlled ventilation or assisted pressure controlled ventilation PCV Pressure Controlled Venti...

Page 39: ...ircuit for each inspiratory effort The switch to the expiratory phase can be triggered If the flow rate falls below the set expiratory threshold Trig E By an expiratory effort from the patient If the...

Page 40: ...raction VT Tidal volume mL RR SIMV Determines the frequency of the mandatory cycles bpm PEEP Positive end of expiration pressure cmH2O Tins Determines the inspiratory time of the mandatory cycles bpm...

Page 41: ...ient Note When this mode is launched apnea ventilation is deactivated for two minutes Note The inspiratory and expiratory plateaus and pauses are disabled in CPAP mode 4 6 7 PRVC Pressure Regulated Vo...

Page 42: ...ined frequency The aim of automatic adaptation of the frequency is to let the patient breathe autonomously when his or her respiratory reflexes are active and allow the ventilator to take over when hi...

Page 43: ...arget volume mL I Trig inspiratory trigger L min RR mini minimum respiratory rate bpm PI max maximum inspiratory pressure cmH2O Slope inspiratory pressure slope cmH2O s E Trig Expiratory trigger of in...

Page 44: ...an the SIMV period supplying a controlled cycle PCV if the time elapsed since the last controlled cycle is greater than the SIMV period If patient respiratory activity declines again after a spontaneo...

Page 45: ...priate ventilation and monitoring the ROSC Return of Spontaneous Circulation phase during a prolonged cessation of chest compressions allowing standard ventilation to be resumed To switch between thes...

Page 46: ...s is confirmed by the sound of 5 audible beeps During this phase the set point panel is pink and 3 measurement blocks specific to cardiopulmonary resuscitation are available These measurement blocks a...

Page 47: ...ns for the ventilation period observed cumulated duration of no CC for the ventilation period observed see CPV Cardio Pulmonary Ventilation on page 45 To access the CPV Report see section Patient moni...

Page 48: ...the humidifier and the patient 5 Check that the humidifier is in working order before switching it on 6 Activate the Hflow function with the desired flow rate setting Note Humidify the flow generated...

Page 49: ...tal alarms that are not applicable in an ECMO context extra corporeal membrane oxygenation See Alarm threshold settings on page 133 for further information Compatible categories and modes The ECLS fun...

Page 50: ...his mode 4 Alarm thresholds in ECLS for this mode Deactivating the ECLS environment To continue ventilation outside the ECLS environment and no longer adjust the alarm thresholds to the ECMO context a...

Page 51: ...patients or children as this carries the risk of increasing resistance The IRMA probe can give poor quality measurements in the presence of devices that emit elec tromagnetic interference exceeding t...

Page 52: ...or before you connect it to the patient The probe can be cleaned using a cloth dipped in alcohol maximum 70 ethanol or 70 iso propanol Remove the adapter before cleaning the probe The adapters are not...

Page 53: ...h FiO2 set at 30 2 Switch to Hflow with FiO2 set at 50 3 When the oxygen therapy session is completed the user launches the PSV mode again FiO2 returns to its previous setting 30 Note The FiO2 setting...

Page 54: ...emorized but not applied In this example a pressure controlled mode PSV follows a volume controlled mode A VCV A VCV PSV PSV A VCV VT 460 mL PEEP 4 cmH2O PEEP 4 cmH2O PEEP 6 cmH2O VT 460 mL PEEP 4 cmH...

Page 55: ...1 and select the new curve from the menu 2 Press Back to cancel Note If the selected curve is already displayed in the curve area the two curves are inverted Note When the respiratory cycle comes fro...

Page 56: ...the curves Freeze function press the Back key Note While the curves are frozen the numerical values of the patient parameters continue to be refreshed on the screen 4 6 17 Monitoring Several monitore...

Page 57: ...ppears the box returns to its original state but the threshold concerned remains in red to indicate that an alarm has been activated Press the threshold to end the display of the threshold in red CAUT...

Page 58: ...he upper insufflated tidal volume VTi threshold also switches off the current inspiration and is forced to change to expiration 4 6 17 2 Automatic thresholds The Auto set button is used to automatical...

Page 59: ...raged over 30 s MVi Inspiratory volume per minute averaged over 30 s Leak Leak percentage non invasive ventilation Pmean Mean pressure of respiratory cycle etCO2 Expired CO2 fraction at end of expirat...

Page 60: ...easured parameter press the curve to be replaced and select the desired parameter from the list on the right Note If the selected curve is already displayed in the curve area the two curves switch pos...

Page 61: ...the device is in stand by mode 4 6 18 Measurements 4 6 18 1 Measurements menu The measurements menu is used to trigger inspiratory and expiratory pauses and take Cstat measure ments Open the menu Not...

Page 62: ...previous settings Note The inspiratory pause is interrupted if a high pressure alarm is triggered Expiratory pause The Expiratory Pause key is used to trigger an expiratory pause limited to 60 second...

Page 63: ...monitoring block Note Inspiratory and expiratory pauses are not available during Cstat measurement Note The Cstat value is displayed for five minutes after the measurement It is then replaced by the...

Page 64: ...Note In case of use with a low flow supply FiO2 may not reach 100 4 6 19 2 Screen lock key Lock To lock the screen press To unlock the screen press then validate with the rotating knob 4 6 19 3 Day N...

Page 65: ...f the FiO2 CO2 and expiratory flow monitoring sensors activation of low pressure O2 the machine s configuration the transfer data command which requires the use of a USB flash drive not accessible dur...

Page 66: ...N OFF Configuration Alarm sound volume Brightness Alarm flash ON OFF Keypad tone ON OFF Date and time Data transfer History log csv Black box blackbox his Trends trends csv CPV report cpv csv 4 7 2 Se...

Page 67: ...from the patient Next press the CO2 sensor calibrat key to launch probe calibration The green LED on the probe flashes for about five seconds during calibra tion Special care must be taken to avoid an...

Page 68: ...standby To set the date and time on the machine press the Date Time key To set each parameter day month year hour minute 1 Turn the rotating knob to display the desired value 2 Press the rotating knob...

Page 69: ...the source and the ventilation settings CAUTION To guarantee satisfactory operation from a low flow O2 supply on a concentrator the high pressure O2 hose must be disconnected from the machine 4 7 6 D...

Page 70: ...tings A VCV setting A PCV setting Tplat unit Support setting RR mini setting Monitoring Clinical screen measurements Restore clinical screen Language Modes A PCV CPAP VSIMV PSIMV PRVC PS Pro APRV Sett...

Page 71: ...ries The Restore Gender Height key resets the default parameters see Settings tables on page 126 Restoration applies to all patient categories 4 8 3 SI Unit The SI Unit function enables the cmH2O unit...

Page 72: ...harged See Table of alarms on page 82for details on the alarm This function is available on page 3 of the Machine menu By default this alarm is deactivated 4 8 10 Saving the ventilation settings and a...

Page 73: ...h of these sources are described in Section Electrical specifi cations on page 112 Note If the unit suddenly shuts down during ventilation e g battery empty when the unit is reconnected to the externa...

Page 74: ...pped with one or two batteries an internal battery INT that cannot be accessed by the user an extractable battery EXT that can be replaced while the ventilator is in operation If there is no grid powe...

Page 75: ...a safety feature of the battery charging sys tem and may interrupt the charging and discharging process of the battery this can signifi cantly affect the charging time and autonomy of the battery Not...

Page 76: ...ly on means the battery charger is malfunctioning 4 10 Inputs and outputs 4 10 1 Video output The video output is located on the side of the machine where the handle is situated a remote screen can be...

Page 77: ...mmunication module Connect the YR135600 cable to the type A USB socket of the Monnal T60 Advanced then connect the other end of the cable to the external device CAUTION A galvanised cable should be us...

Page 78: ...e to previous ly unidentified risks to patients operators or third parties The user should identify analyse evaluate and manage such risks Subsequent modifications made to the hospital network could l...

Page 79: ...alarm Ultra category high priority alarm caused by the ventilation stopping 5 1 Display 1 1 2 2 3 3 4 4 1 Alarm indicator 2 Alarm text or information message 3 Arrow indicates several active alarms 4...

Page 80: ...alarm with the lowest No is visible Technical alarms To indicate a technical error the alarm also displays the symbol and a number so that the technical department can identify the exact source of th...

Page 81: ...the screen Pressing this key a second time cancels the preventive inhibition The inhibited alarms concern the alarms relating to monitoring and patient disconnection In the event of a technical alarm...

Page 82: ...t cir cuit Check the expiratory valve membrane Contact your technical department if the prob lem persists Expiration is prolonged for a maximum of 15 s until the measured PEEP returns below the PEEP s...

Page 83: ...on phase 10 Error detected Contact the technical depart ment HIGH Electronics failure Connectivity tests per formed every second Use a different unit and contact your technical department 11 Error det...

Page 84: ...cycle Check the level of leak age Check the suitability of alarm level settings with the ventilation settings in progress 18 Low respiratory rate MEDIUM Measured frequency below the alarm thresh old I...

Page 85: ...ventilation settings in progress 25 Low FiO2 HIGH Measured FiO2 below the set threshold Inhibition for 60 s on ventilation start up Immediate triggering Inhibition for 60 s in adult and child mode an...

Page 86: ...erent unit and contact your technical department 36 Safety Ventilation Recommend switching ventilator HIGH Electronics failure Immediate triggering Use a different unit and contact your technical depa...

Page 87: ...e of the O2 sensor or the measured FiO2 is below 18 Immediate triggering Check that the O2 sen sor is installed check its connection and re run the automatic tests Replace the O2 sensor and re run the...

Page 88: ...failure Immediate triggering Use a different unit and contact your technical department 54 Sounder failure Ventila tion Effective MEDIUM Electronics failure Immediate triggering Use a different unit...

Page 89: ...el of leak age Check the suitability of alarm level settings with the ventilation settings in progress In pressure control ven tilation mode when the VTi high alarm thresh old is reached the unit swit...

Page 90: ...iggering when ventilation shuts down or when unit is started up Not applicable 73 Screen upside down None INFO cat egory Press the 180 key Immediate triggering Press the control wheel to confirm scree...

Page 91: ...he probe has exceeded the maximum measure ment threshold Immediate triggering If the atmospheric pres sure is normal replace the probe 85 etCO2 high MEDIUM etCO2 measurement above the threshold set ti...

Page 92: ...eration on a low pressure source select Low pressure O2 from the configuration menu 95 O2 maximum for 2 min None INFO cat egory Press the 100 O2 key Start of next ventilation cycle Not applicable 96 O...

Page 93: ...rrent or tempera ture outside tolerance Triggering within 10 s Use a different unit and contact your technical department 104 Auxiliary battery temper ature measurement er ror HIGH Correct voltage at...

Page 94: ...m persists Change the patient cir cuit This error affects Auto Tests pauses only 114 Rebreathing detected MEDIUM Inspiratory CO2 above threshold 4 mmHg Immediate triggering Check ventilation set tings...

Page 95: ...Check the humidifier Check the patient inter face 128 Alarms inhibited None INFO cat egory Press the alarm inhibi tion key if enabled and there is no current alarm 3 seconds Not applicable 129 Error d...

Page 96: ...for 13 months Immediate triggering Contact the technical department to carry out preventive mainte nance The alarm can be ac knowledged 138 Safety Ventilation Rec ommend switching ven tilator HIGH Tu...

Page 97: ...the alarm threshold Inhibition for 60 s when ventilation starts Inhibition during a pause and 30 s after the pause Triggering after 30 s Check the consistency between the alarm lev els and the ventil...

Page 98: ...N Follow the instructions of the product s manufacturer Surface cleaning and disinfection precautions CAUTION Before the operation power off Monnal T60 Advanced insert the USB cover to stop liquid fro...

Page 99: ...ticles 0 5 m 6 4 Expiratory assembly Flow sensor expiratory valve There are two types of expiratory assembly single use assemblies and autoclavable assemblies re usable The sensor and the single use e...

Page 100: ...piratory flow sensor requires special precautions during pre disinfection cleaning and disinfection It contains a very fine fragile platinum wire It is therefore important to Avoid inserting any objec...

Page 101: ...7142 PSIMV PS Pro PRVC pack modes Monnal T60 Advanced KA017139 PS Pro mode Monnal T60 Advanced KA017141 Expiratory assemblies Monnal Eva expiratory valve x5 valve body and membrane KY694800 Monnal Eva...

Page 102: ...M KM222200 Single use Non vented full face mask size L KM222300 Non vented full face mask size S KM218800 Non vented full face mask size M KM218900 Non vented full face mask size L KM219000 Respireo c...

Page 103: ...3 cm tube diam 38 mm KA017000 Tube arm length 20 3 cm tube diam 38 mm with clip diam 19 51 mm KA017100 Assembly on vertical rail thickness 10 x width 25 40 mm Vertical rail arm 30 5 cm long KA016500...

Page 104: ...93 42 CEE as well as IEC 60601 1 and collateral standards Accessories from the Air Liquide Medical Systems catalogue or included in the accessories kit deliv ered with the ventilator comply with thes...

Page 105: ...ery six months Replace the O2 sensor see O2 Cell on page 106 and expiratory flow sensor in the event of fail ure Check the remaining battery capacity approximately every six months connect a test lung...

Page 106: ...e ambient temperature To open the compartment turn and loosen the hatch Disconnect the used sensor and then unscrew it using the tool provided to remove it from its hous ing Replace it with a new sens...

Page 107: ...lve APS3 Atmospheric pressure sensor C4 Non return valve PS4 O2 pressure sensor F1 O2 inlet filter oxygen low pressure supply T Turbine F2 Air intake filter HEPA filter TS Patient gas temperature sen...

Page 108: ...for a flow by rate of 5 L min This flow limits reinhalation and allows quick detection of an inspiratory demand Note During ventilation with leakage such as NIV the turbine T is liable to increase the...

Page 109: ...s a mixture at the correct FiO2 level The concentration of the mixture may however not be reached because this depends on The type of low O2 pressure supply system and its settings the O2 flow supplie...

Page 110: ...rtial pressure of oxygen However a compensation of this pressure is applied each time the automatic tests are launched Am bient humidity also affects the oxygen measurement at the rate of 0 03 per Hr...

Page 111: ...nsation at 40 C max Atmospheric pressure 600 to 1150 hPa from 500 m to 4 000 m ap proximately Temperature 10 C to 40 C 14 F to 104 F Storage conditions Relative humidity 0 95 without condensation at 4...

Page 112: ...nsumption 120 VA max 0 12 kW Electrical class II Type BF Leak current IEC 60601 1 compliant Protection following a loss of power Continuous audible alarm and patient vented to atmosphere Cable type 2...

Page 113: ...20 minutes per battery quick charge with machine in stand by Typically 5 5 hours per battery slow charge with machine ventilating according to environmental conditions and type of power supply Note T...

Page 114: ...cm3 Adult single use patient Catalog Number KG020100 Resistance at 60 L min 0 4 cmH2O Compliance 1 ml cmH2O Volume 1216 cm3 Pediatric single use patient circuit with water trap Catalog Number KG019400...

Page 115: ...will guarantee precision Minimum flow rate to guarantee precision 5 L min Drift of measuring precision over six hours 3 Vol Response time at 90 extreme conditions 60 s if volume 300ml 90 s if volume b...

Page 116: ...cycle Frequency RR bpm 1 120 0 1 1 4 cycles Ratio of inspiratory time to total time Ti Ttot 10 50 1 1 1 cycle Ratio of inspiratory time to expiratory time I E 1 1 1 9 0 1 0 1 1 cycle Insufflated tidal...

Page 117: ...L min Adjustable on successive scales 10 to 10 20 to 20 40 to 40 80 to 80 160 to 160 Pressure cmH2O Adjustable on successive scales 0 to 20 0 to 40 0 to 60 0 to 100 14 These accuracy values are ensure...

Page 118: ...ion modes VCV controlled ventilation or assisted vol ume controlled ventilation A VCV PCV controlled ventilation or assisted pres sure controlled ventilation A A PCV PSV spontaneous ventilation with i...

Page 119: ...e of 3 cmH2O is detected on the inspiratory pressure signal Expiratory time trigger TI max expiration as soon as the in sufflation time reaches the maximum Ti setting Timax Automatic tests Initializat...

Page 120: ...stances 24 Resistances at 60 L min cmH2O machine single use adult patient circuit KG020100 filter KV103300 Inspiratory 4 73 Expiratory 4 89 Resistances at 30 L min cmH2O machine single use child patie...

Page 121: ...bile phones may interfere with the medical device The recommended separation distances in this section must therefore be strictly ob served The medical device must not be used in close proximity to ot...

Page 122: ...11 Class A Emission of harmonic cur rents IEC 61000 3 2 Voltage fluctuation and volt age flickers IEC 61000 3 3 Electrostatic discharge im munity IEC 61000 4 2 Radiated immunity Electro magnetic fiel...

Page 123: ...tromagnetic environment Immunity test Test level according to IEC 60601 1 2 Compliance level Electromagnetic environ ment comments Electrostatic discharges ESD IEC 61000 4 2 8 kV contact discharge 15...

Page 124: ...agnetic environ ment comments WARNING RF hand held communication devices should not be used including peripherals such as antenna cables and exter nal cables within a radius of 30 cm 12 inches of any...

Page 125: ...not apply in all situations Electromagnetic propagation is affect ed by absorption and reflection from structures objects and people a The electromagnetic field strengths of fixed radio frequency tran...

Page 126: ...0 13 1 5 60 13 1 Inspiratory assis tance pressure PSV NIV PS 25 cmH2O 5 25 8 1 5 25 8 1 5 25 8 1 Insufflation pres sure APRV P high cmH2O 5 60 15 1 5 60 15 1 5 60 15 1 Insufflation pres sure CPV CPR p...

Page 127: ...CPR phase PL sync cmH2O 0 15 5 1 NA NA NA NA Expiratory pres sure CPV ROSC phase PEEP cmH2O 0 15 5 1 NA NA NA NA I E ratio A VCV A VCV NIV A PCV A PCV NIV PRVC I E 1 9 2 0 1 1 9 2 0 1 1 9 2 0 1 Inspi...

Page 128: ...30 10 10 90 30 10 Expiratory trigger VSIMV E Trig 10 90 30 10 10 90 30 10 10 90 30 10 Expiratory trigger PSIMV PS Pro E Trig 10 90 30 10 10 90 30 10 10 90 30 10 Expiratory trigger PSV NIV E Trig 10 90...

Page 129: ...on frequency All ex cept A VCV A VCV NIV A PCV A PCV NIV PS Pro PRVC APRV CPV RR ap nea c min 5 40 15 1 5 60 25 1 10 80 40 1 Trigger duration All ex cept A VCV A VCV NIV A PCV A PCV NIV PS Pro PRVC AP...

Page 130: ...d User manual Accuracy of delivered values compared to set values VTi 50 mL 11 5 mL VTi 50 mL 4 mL 15 Pressure PEEP PI PS 2 cmH2O 4 FiO2 5 percentage points under the conditions specified by standard...

Page 131: ...20 46 116 20 22 49 124 23 26 51 129 25 28 Child 52 132 26 31 54 137 31 35 56 142 36 40 58 147 40 45 60 152 45 49 62 157 49 54 64 162 54 58 66 167 58 63 68 172 63 67 70 177 67 72 72 182 72 76 74 187 7...

Page 132: ...Adults Devine Formula Drug Intell Clin Pharm 8 650 Predicted weight man 50 2 3 height 60 Predicted weight woman 45 5 2 3 height 60 9 2 4 Interdependency of settings PCV Mode Pressure Support Ventilat...

Page 133: ...trolled modes A PCV PSV CPAP APRV PSIMV PRVC PS Pro OFF then 10 min val ue 2 000 or high VTe threshold 50 OFF OFF then 10 min val ue 1 950 or high VTe threshold 50 OFF OFF then 10 min value 790 or hig...

Page 134: ...VTi threshold 50 2 000 1 000 max value 20 or low VTi threshold 10 800 100 High inhaled volume VTi Volumetric modes A VCV VSIMV 10 max value 50 or Vt setting 50 3 000 2 000 max value 50 or Vt setting...

Page 135: ...e Ppeak Mea sured pressure 33 If low Ppeak higher than 5 Mea sured pressure max value 20 or 5 Otherwise 1 No auto threshold If low Ppeak higher than 5 Mea sured pressure max value 20 or 5 Otherwise 1...

Page 136: ...auto thresh old 9 3 Recovery of the components of the medical device Characteristics of the packaging Box for transportation 800 g and wedge 200 g Recycled paper Recyclable Protective foam 1 kg Polyet...

Page 137: ...ckaging Battery and oxygen sensor return process It is recommended that you contact your local distributor for information on the channels and the terms and conditions of return Equipment modification...

Page 138: ...c safety and es sential performance Collateral standard Electromagnetic compatibility Requirements and tests IEC 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety a...

Page 139: ...well as a com pliance value Launch the A VCV mode with an FiO2 setting of 100 After one minute of ventilation check that no technical alarm is present this test is used to check the addition of oxy g...

Page 140: ...Monnal T60 Advanced User manual 10 2 Maintenance data sheet 140...

Page 141: ...the flow sensor Avoid exposing it to a jet of water or air Avoid impacts or dropping it Pre disinfection cleaning 1 Immerse the expiratory assembly components in a pre disinfectant solution Note Air L...

Page 142: ...rm an automatic test after each assembly of the expiratory valve and the flow sensor CAUTION Incorrect reassembly of the expiratory assembly wrong positioning of the mem brane in the valve body remova...

Page 143: ...A Parc de Haute Technologie 6 rue Georges Besse 92182 ANTONY CEDEX FRANCE Tel 33 0 1 40 96 66 00 Fax 33 0 1 40 96 67 00 Hotline 33 0 1 79 51 70 01 www device airliquidehealthcare com YL180136 Revisio...

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