Air Liquide MONNAL T60 ADVANCED User Manual
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Air Liquide MONNAL T60 ADVANCED User Manual

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User Manual
English
Software Version V1.1.x
www.device.airliquidehealthcare.com
| MONNAL T60 ADVANCED
V1.1.xI4
YL180136

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Summary of Contents for Air Liquide MONNAL T60 ADVANCED

  • Page 1 | MONNAL T60 ADVANCED User Manual English Software Version V1.1.x V1.1.xI4 YL180136 www.device.airliquidehealthcare.com...

  • Page 3: Table Of Contents

    Contents Before use....................7 Symbols used in this manual......................7 Intended use............................7 Requisite knowledge.......................... 8 Brief description of the device......................8 Symbols and markings on the device....................9 General safety instructions......................11 Description of the device...............15 Terminology Used..........................15 Front view............................15 Handle side............................
  • Page 4 Starting/stopping ventilation......................33 Availability of the modes......................... 36 Stopping the device......................... 36 Ventilation modes and functions.....................37 Apnea ventilation adjustment......................37 VCV (controlled ventilation or assisted volume-controlled ventilation)......... 37 (A)PCV (controlled ventilation or assisted pressure-controlled ventilation)........38 PSV (spontaneous ventilation with inspiratory assistance and PEEP).......... 39 SIMV..............................
  • Page 5 Inputs and outputs...........................76 Video output............................76 USB Connections..........................76 Connectivity to hospital networks....................77 Alarms and other messages..............79 Display..............................79 Alarm Acknowledgement.........................80 Alarm inhibition..........................81 Preventive alarm inhibition......................81 Reset..............................81 History.............................. 81 Table of alarms..........................82 Maintenance..................98 Surface of the ventilator........................98 Bacteriological filter.........................98 Air inlet filter (Monnal Clean’In)......................
  • Page 6 Expiratory assembly cleaning protocol..................141 Monnal EVA autoclavable expiratory assembly................142 Monnal EVA single-use expiratory assembly.................142...

  • Page 7: Before Use

    Note: Highlights a particular item of information. 1.2 Intended use Monnal T60 Advanced is a standalone ventilator using air (propelled by a blower) used to treat infants (3 kg and above), children, and adults. It is used for patient ventilation to compensate for or mitigate respiratory failure. Contact with the pa- tient is made via an adequate patient interface (e.g., mask or endotracheal tube), which allows air to...

  • Page 8: Requisite Knowledge

    The training includes daily recommended maintenance practices. 1.4 Brief description of the device Monnal T60 Advanced can supply tidal volumes from 20 to 2000 mL in volume-controlled mode, and insufflation pressures from 5 to 60 cmH O in pressure-controlled mode.

  • Page 9: Symbols And Markings On The Device

    Weight and rated output of product Oxygen cell hatch open Manufacturer Complies with European Directive 93/42/CEE. Notified Body No. 0459. Weight of Monnal T60 Advanced de- Expiratory valve eject button vice Device Catalogue Number Weight of the complete system (Monnal T60 Advanced with a rolling...
  • Page 10 Monnal T60 Advanced - User manual IRMA CO2 probe connector ™ Protection Index according to the IP34 EN 60529 standard 3: protection from the penetration of Patient circuit inspiratory fitting solid bodies of diameter ≥ 2,5 mm. 4: protection from water splashing...

  • Page 11: General Safety Instructions

    1 Before use Storage information - Indications on the packaging Minimum and maximum humidity. Minimum and maximum tempera- ture. Minimum and maximum atmos- pheric pressure. Symbols and markings relating to accessories Universal Device Identi- Medical Device. fier. Specific symbols for IRMA measurement probe ™...
  • Page 12 • The Monnal T60 Advanced should not be placed next to or on top of this equipment. If such use is necessary, the Monnal T60 Advanced should be observed together with the other ventilators to en- sure that they are operating normally.
  • Page 13 • The replacing of cables or internal components with cables or components that are not supplied by Air Liquide Medical Systems may result in an increase in emissions or a decrease in the immuni- ty of the device. Connection to other electrical devices •...
  • Page 14 Monnal T60 Advanced - User manual • During transport, the use of Monnal T60 Advanced outside of its bag does not ensure compliance with EN 13718-1, EN 1789 and EN 794-3 standards. Risk of cross-contamination • Reusing single-use accessories or consumables carries the risk of patient cross-contamination.

  • Page 15: Description Of The Device

    2 Description of the device 2 Description of the device 2.1 Terminology Used The expiratory assembly denotes the expiratory flow sensor and the expiratory valve. The expiratory valve designates the valve body, the membrane and the silicone discs. 2.2 Front view Touch screen (8.4 inches) Handle: To carry the machine easily.

  • Page 16: Handle Side

    Monnal T60 Advanced - User manual 2.3 Handle side 8. Secondary air inlet 9. Speaker 2.4 Base side 10. Electrical connection with the hot wire expiratory flow sensor (expiratory assembly withdrawn) 2.5 Right-hand side: Patient circuit connection panel IRMA probe connector socket ™...

  • Page 17: Left-Hand Side: Turbine Air Inlet Panel

    2 Description of the device 2.6 Left-hand side: Turbine air inlet panel 17 18 ON/OFF button Electrical power supply connector Anti-pull cable protection clip High-pressure oxygen inlet Cooling vent Extractable battery housing Low-pressure oxygen inlet Air inlet 2.7 Rear panel 25.

  • Page 18: Installation And Commissioning

    Monnal T60 Advanced - User manual 3 Installation and commissioning 3.1 Unpacking Remove the ventilator from the packaging and place it horizontally on a table. Unwrap the accessories supplied with the ventilator. CAUTION: Before using on a new patient, and before the first use of this device, you must clean and disinfect the accessories (see section Maintenance on page 105).

  • Page 19: Installation On The Wheel Stand

    3 Installation and commissioning 3.3 Installation on the wheel stand Installation example of Monnal T60 Advanced (1) on the wheel stand, with the humidifier (4) and the oxygen cylinder (3): Note: The articulated arm for the patient circuit is installed on one of the fastening points (2).

  • Page 20: Electrical Power Supply

    CAUTION: Leave enough space behind the device for removing the cord from the power out- 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 21% oxygen, connect the ventilator’s high- or low-pressure O...

  • Page 21: Assembly Of The Patient Circuit And Of The Accessories

    (1). It must be placed on the Y-shaped part(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 circuits con- taining phthalates or bisphenol A poses risks for pregnant women, lactating women, and chil- dren.

  • Page 22: Co Measurement Probe (Irma )

    ™ Note: CO monitoring requires a software option that can be enabled using a code. To use this option, contact your Air Liquide Medical Systems representative After purchasing this option, Air Liquide Medical Systems provides: • the activation code for the option, •...
  • Page 23 (d). Position the IRMA probe (e) (see photo opposite). ™ Note: The probe sends information and alarms to the Monnal T60 Advanced. The probe has an LED indicating the following statuses: LED status Description...

  • Page 24: Humidifier

    Monnal T60 Advanced - User manual 3.8 Humidifier If this ventilator is used with a humidifier, ensure that it is always placed lower than the ventilator and the patient. It is also recommended that you use patient circuits equipped with water traps when using a humidifi- CAUTION: Remember to empty the water traps regularly during ventilation.

  • Page 25: Applying Power

    In particular, they calibrate certain sensors, including the expiratory flow sensor and the oxygen cell. Without these tests, the precision of ventilation parameters and measurements cannot be guaranteed. Note: Air Liquide Medical Systems therefore recommends the running of these automatic tests before each use on a patient.

  • Page 26: Use

    Monnal T60 Advanced - User manual 4 Use This ventilator is controlled mainly via 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 the control wheel.

  • Page 27: Start Screen

    4 Use 4.1.1 Start screen This screen is displayed when the machine is started. Access to the menu. Inhibition of the audible alarms. Display of messages, alarms and the soft- Screen lock. ware version (Alarm panel). Day/Night control. 180° rotation of the screen. Status of the grid power connection.

  • Page 28: Ventilation Screen

    Monnal T60 Advanced - User manual 4.1.2 Ventilation screen Access to the home screen during ven- Access to the configuration menu. See tilation. See Home screen (ventilation in Menu on page 65. progress) on page 28. Ventilation parameters monitored. Display of the length of time since a ventila- tion mode was first launched.

  • Page 29: Ventilator Controls

    4 Use 1 Return to the ventilation screen. 2 Parameters monitored. 3 Set parameters of the ventilation mode in progress. 4.1.4 Ventilator controls Function buttons To activate a function, press the corresponding button. Press again to deactivate the function. Ventilation settings Press the setting to adjust it.
  • Page 30 Monnal T60 Advanced - User manual Monitoring blocks Alarm thresholds are represented by the following sym- bol: . Each threshold is selected by pressing this up or down symbol. Adjust the value by turning the control wheel, and press the control wheel to validate.

  • Page 31: New Patient

    4 Use 4.2 New patient CAUTION: For the safety of the patient and to optimize ventilation performance, the patient characteristics should be appropriate to the patient being ventilated. 4.2.1 Selecting the patient category Selecting the patient category enables the following elements to be adapted to the patient's morpholo- •...
  • Page 32 Monnal T60 Advanced - User manual Patient category VT range (mL) Internal diameter of patient circuit tub- ing (mm) 20 - 75 Between 10 and 12 mm Infant ≥3kg Note: The user can only change the patient category via the start-up or stand-by screen.

  • Page 33: Starting/Stopping Ventilation

    4 Use 4.3 Starting/stopping ventilation Starting ventilation Define the patient category desired (adult, child or infant) on the start screen (see section New patient on page 31) Select the type of interface with the patient: Invasive ventilation or Non-invasive ventilation.
  • Page 34 Monnal T60 Advanced - User manual Select the ventilation mode. See Availability of the modes on page 36. Note: In Invasive ventilation, the list of modes is displayed on two pages. High and low alarm thresholds Press to move from one page to the other.
  • Page 35 4 Use Stopping ventilation Press Pause A dialog box appears. 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 the same parameters as the previous ventilation operation.

  • Page 36: Availability Of The Modes

    Monnal T60 Advanced - User manual 4.4 Availability of the modes Invasive Non-invasive Optional (A)VCV (A)PCV CPAP VSIMV APRV PS-Pro PRVC PSIMV 4.5 Stopping the device Press the ON/OFF button (left-hand side of the machine): Press the rotating knob to confirm or press Cancel to cancel shutdown.

  • Page 37: Ventilation Modes And Functions

    CAUTION: 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 ventilation adjustment should be performed before starting ventila- tion.

  • Page 38: A)Pcv (Controlled Ventilation Or Assisted Pressure-Controlled Ventilation)

    Monnal T60 Advanced - User manual The respiratory rate can be increased as soon as the ventilator detects that the patient is making a res- piratory effort Set-points FiO2 inspired oxygen fraction tidal volume (mL) minimum respiratory frequency (bpm) PEEP...

  • Page 39: Psv (Spontaneous Ventilation With Inspiratory Assistance And Peep)

    4 Use Slope inspiratory pressure slope (cmH O/s) enabling the sigh function if ≠ OFF sigh pressure supplied during a sigh (unit x PI; e.g.: PI sigh = 1.4 PI) Sigh sigh periodicity (1 sigh every x cycles) Note: The PI value corresponds to the total inspiratory pressure applied to the patient. The PEEP value is incorporated in the PI.

  • Page 40: Simv

    Monnal T60 Advanced - User manual • Use of the ‘RR min’ parameter: in the absence of inspiratory demand for a time exceeding ‘1/RR minimum’ of a minute. The ventilator initiates a pressure support cycle. The RR low alarm can be associated with this safety feature by setting it to a value above RR min.

  • Page 41: Cpap (Continuous Positive Airway Pressure)

    4 Use • supplying a ‘spontaneous’ cycle (PSV) if the time elapsed since the last controlled cycle is less than the SIMV period. • supplying a ‘controlled’ cycle (VCV) if the time elapsed since the last controlled cycle is greater than the SIMV period.

  • Page 42: Ps-Pro (Pressure Support - Pro)

    Monnal T60 Advanced - User manual CAUTION: The “VT target and regulated pressure incompatibility!!!” alarm is activated when: • Monitored volume < 90% of the VT Target and delivered PI = PI Max • Monitored volume > 110% of the VT Target and delivered PI = PEEP + 5 cmH •...

  • Page 43: Psimv (Synchronized Intermittent Mandatory Pressure Monitored Ventilation)

    4 Use Note: For operation of the VT Target function, refer to PRVC mode. CAUTION: The set minimum frequency is a safety threshold below which the ventilator pro- vides controlled ventilation based on the set patient frequency. If the patient is disconnected, the frequency is no longer adapted until the patient is recon- nected.

  • Page 44: Aprv (Airway Pressure Release Ventilation)

    “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 “spontaneous” cycle, Monnal T60 Advanced waits for the SIMV period to expire before triggering a “controlled” cycle (PCV).

  • Page 45: Cpv: Cardio-Pulmonary Ventilation

    4 Use Slope slope of the rise in pressure of pressure support (cmH O/s) Note: The absence of a patient breath during the time of apnea (Tapnea) activates apnea ventilation. Note: The value of the P high setting is absolute: this means that the high pressure level will be equal to P high, without taking into account the set PEEP level.
  • Page 46 Monnal T60 Advanced - User manual It enables comparison of the instantaneous CO2 value with the average CO2 concentration line, in or- der to reveal a sudden variation in the CO2 level. 4.6.11.4 Chest compression phase set-points fraction of oxygen inhaled...

  • Page 47: Function Hflow

    This function is used for non-ventilation dependent patients and may be used before NIV. It has ad- justable flow rates which are able to cover the patient’s peak inspiratory flow and consequently control the FiO2 delivered. The Hflow function is available for all categories of patients treated with Monnal T60 Advanced (adult, child and infant).
  • Page 48 Note: Please refer to the patient/machine interface manual. Set-up Install the humidifier on the Monnal T60 Advanced stand; Note: Place the humidifier lower than the patient to prevent water flowing into the cir- cuit. Perform an automatic test with a dual branch circuit (see section Automatic tests on page 25);...

  • Page 49: Ecls Function

    4.6.13 ECLS function Principle The ECLS function (extra-corporeal life support) of Monnal T60 Advanced ensures that the machine is adapted to the patient with extra-corporeal membrane oxygenation systems. This function enables the settings of the alarm thresholds to be modified automatically to limit acci- dental alarms that are not applicable in an ECMO context (extra-corporeal membrane oxygenation).
  • Page 50 Monnal T60 Advanced - User manual The ventilation screen in the ECLS environment Launch of the Default (A)VCV mode and Display of the ventilation mode in the ECLS deactivation of the ECLS environment. environment. Settings available in ECLS for this mode.

  • Page 51: Co2 Option

    Standard 60601-1-2. Ensure that it is used in a suitable environment. • Only Air Liquide Medical Systems adapters may be used with the IRMA ™ probe. CAUTION: Use only IRMA ™...
  • Page 52 Monnal T60 Advanced - User manual • Do not use the IRMA ™ probe at a temperature below 0°C or above 40°C. • During use, ensure that the IRMA ™ probe is connected to the ventilator before you connect it to the patient.

  • Page 53: Keeping Alarm Settings And Thresholds

    4 Use 4.6.15 Keeping alarm settings and thresholds When changing ventilation mode, and depending on the case, the alarm settings and thresholds may be kept or discarded. There are 3 scenarios: Hflow When a Hflow session is launched, the settings and thresholds of this function are applied, without taking into account the settings of the previous mode.
  • Page 54 Monnal T60 Advanced - User manual Other modes When switching from one ventilation mode to another (excluding emergency modes and excluding ECLS), the values of the settings and of the thresholds are saved. For the settings and thresholds that are not common to the two modes (for example, the VT in a pressure-controlled mode), the values are memorized but not applied.

  • Page 55: Displaying The Curves

    4 Use 4.6.16 Displaying the curves Eight curves are available: flow rate, pressure, volume, flow rate / pressure, volume / CO2 and CO2 (if the etCO2 software option is enabled). Two curves are displayed continuously and in real time. Only one is displayed in the case of loop curves.

  • Page 56: Monitoring

    Monnal T60 Advanced - User manual 4.6.16.2 Freezing of curves Pressing the Freeze key freezes the curves. Two cursors (vertical lines) serve to measure and display the values of each curve. The cursor that is currently selected appears in green.
  • Page 57 4 Use The measurement boxes also serve to set the alarm thresholds. 4.6.17.1 Adjustment of alarm thresholds The alarm thresholds can be accessed and adjusted directly via the ventilation screen. To adjust a threshold: • Select the high or low threshold: it is highlighted. •...
  • Page 58 Monnal T60 Advanced - User manual Particular case of peak airway pressure (Ppeak) and maximum tidal volume (MTV) In all modes, exceeding the upper Ppeak threshold switches off the current inspiration and is forced to change to expiration. Furthermore, in non-invasive pressure-controlled ventilation modes, exceed- ing the upper insufflated tidal volume (VTi) threshold also switches off the current inspiration and is forced to change to expiration.
  • Page 59 4 Use 4.6.17.3 Display of measurements List of measured parameters (those with alarm thresholds must be present) on two pages: Measurements Type of information FiO2 Insufflated oxygen fraction measured every second Volume exhaled during the cycle Respiratory rate averaged over 4 cycles Ti/Ttot Ratio of inspiratory time to total time Ratio of inspiration time to expiration time...
  • Page 60 Monnal T60 Advanced - User manual 4.6.17.4 Trends This function allows the user to track the following measured ventilation parameters: Ppeak PEEP TI/Ttot FiO2 Pplat Leak RR CC % CC This screen can display two trend curves at the same time.

  • Page 61: Measurements

    4 Use Users can display the exact values at a given point in time (date and time) of the ventilation parame- ters selected with the cursor. The patient's treatment date, which corresponds to the position of the cursor, is indicated (last 80 hours of ventilation maximum). Note: Measured ventilation parameters are also stored in memory when the device is in stand-by mode.
  • Page 62 Monnal T60 Advanced - User manual Display of monitoring blocks When the measurements menu is open, the display is adapted. The following monitoring blocks are displayed on a single page: PEEP VTe/PBW Pplat Cdyn/Cstat Leak Ppeak Close the menu To close the measurements menu and display the set monitoring blocks, press Back.
  • Page 63 4 Use When the inspiratory plateau is not activated, the Pplat measurement displays: 4.6.18.3 Cstat measurement The static compliance measurement Cstat is used to occasionally evaluate the compliance of the pa- tient's airways (in mL/cmH The result is recorded in the monitoring block and in trends. To measure the static compliance: Open the measurements menu (see Measurements menu on page 61).

  • Page 64: Other Functions

    Monnal T60 Advanced - User manual Infant Child Adult Expiratory pause 500 ms Inspiratory pause 4.6.19 Other functions 4.6.19.1 100% O2 The 100% O2 key allows you to set FiO2 automatically to 100%. After two minutes or a second press of the key, FiO2 returns to its initial value.

  • Page 65: Menu

    4 Use 4.7 Menu The menu is accessible from the start, ventilation and standby screens. It provides access to: • patient monitoring, • activation of the FiO , CO and expiratory flow monitoring sensors, • activation of low pressure O •...

  • Page 66: Menu Structure

    Monnal T60 Advanced - User manual 4.7.1 Menu structure Sensors monitoring (ON/OFF) etCO monitoring (ON/OFF) Exp monitoring (ON/OFF) sensor calibration Patient monitoring History Trends CPV report Low-pressure O2 ON/OFF Configuration Alarm sound volume Brightness Alarm flash (ON/OFF) Keypad tone (ON/OFF)

  • Page 67: Patient Monitoring

    4 Use Note: By default, FiO monitoring and monitoring of the expiratory flow are enabled. etCO monitoring is enabled automatically when the CO probe is connected to the ventilator. When the CO probe is connected or enabled, the CO sensor calibrat. key is used to calibrate the probe.

  • Page 68: Low-Pressure O

    Monnal T60 Advanced - User manual Note: The audible alarm is for a health professional near the patient. The maximum distance away and the volume of the alarm must therefore be determined by the user according to the situation. CAUTION: You must set a higher volume than the ambient noise. A volume that is too low may prevent users from hearing the alarm.

  • Page 69: Data Transfer

    4 Use Note: During operation with a high-pressure source, the 100% O function can be enabled. This possibility is maintained in low-pressure operation dependent on the O supply flow and the patient’s ventilation. The maximum concentration that can be achieved nonetheless de- pends on the source and the ventilation settings.

  • Page 70: Customizing The Device

    Monnal T60 Advanced - User manual 4.8 Customizing the device The following settings are available in the configuration menu. Contact the technical department to ac- cess this menu. Ventilator Home screen button Activate options Patient (default patient, configure gender/size, reset gender/size)

  • Page 71: Gender /Height Configuration

    4 Use To access this setting, select Ventilator, then Patient. Note: If the Patient sett. back-up function is activated when the ventilator is switched on, the category corresponds to that of the last ventilated patient. See Saving the ventilation settings and alarm thresholds on page 72.

  • Page 72: Display Of The Ventilation Timer

    Monnal T60 Advanced - User manual 4.8.7 Display of the ventilation timer This function allows you to enable or disable the display of the ventilation timer. It is available on page 3 of the Ventilator menu. By default, the timer is displayed.

  • Page 73: Set-Point Selection

    4 Use Note: If it is started up without a patient category selection, the following settings are re- tained: • Patient type (category, height and gender) • Ventilation mode (set-points, alarm thresholds) 4.8.11 Set-point selection The Set-points function is used to select the set-points to be used according to application: •...

  • Page 74: Ac Power Supply

    This LED is extinguished in the absence of mains or during battery-powered operation. 4.9.3 Extractable battery and internal battery Monnal T60 Advanced is equipped with one or two batteries: • an internal battery (INT) that cannot be accessed by the user.
  • Page 75 4 Use Battery dangerously low—imminent shutdown For the internal battery, the pictogram is associated with a high-priority, non-ac- knowledgeable alarm “Batteries inoperative!!! Connect AC power.” It is then urgent to connect the ventilator to the mains or to replace the auxiliary battery to prevent it from shutting down due to a lack of power.

  • Page 76: Led Battery Status Indicator

    Monnal T60 Advanced - User manual 4.9.4 LED battery status indicator The status of the internal and removable batteries is also shown by two LED lights on the front of the machine. These LEDs allow the user to view the machine charge status when the machine is connect- ed to the mains and the screen is switched off (the LEDs show the battery status when on or in stand- by mode).

  • Page 77: Connectivity To Hospital Networks

    Note: Contact the IT manager to select the appropriate protocol. Connecting the communication 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.
  • Page 78 Cybersecurity To ensure the security of our device and of the hospital's information systems, access to the Monnal T60 Advanced ventilator must be controlled. Only physical access to Monnal T60 Advanced might in- troduce a cybersecurity risk.

  • Page 79: Alarms And Other Messages

    5 Alarms and other messages 5 Alarms and other messages In some circumstances, Monnal T60 Advanced warns the user that action is required using audible and visual alarms. Monnal T60 Advanced can also display information messages on the screen. There are 5 categories of alarms and messages: •...

  • Page 80: Alarm Acknowledgement

    Monnal T60 Advanced - User manual The alarm lights on the front of the device also indicate an alarm: Category Alarm lights Ultra and high Fast flashing red (twice per second) Medium Slow flashing yellow (once every two seconds) Continuous yellow...

  • Page 81: Alarm Inhibition

    5 Alarms and other messages 5.3 Alarm inhibition Pressing the alarm inhibition key interrupts the alarms for 2 minutes. Press this key to cancel alarm inhibition. The alarm message remains on the screen. However, if another audible alarm with a higher priority replaces it, the sound inhibition is automatical- ly disabled and the audible emission of the new alarm begins.

  • Page 82: Table Of Alarms

    Monnal T60 Advanced - User manual Note: When the log reaches its maximum size, the oldest events will be overwritten by in- coming events. 5.7 Table of alarms Alarms Priority Alarm activation Alarm activation delay Actions Stop ventilation? MEDIUM Immediate triggering...
  • Page 83 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions Patient disconnection!!! HIGH Patient disconnection Inhibition for 60 s when Check the leakage level. or excessive leakage, or ventilation starts. electronic malfunction Check the "adult/child" Inhibition during a patient setting.
  • Page 84 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions Incorrect alarms set- HIGH Alarm settings are not Immediate triggering Check and amend the tings!!! technically achievable, alarm thresholds if nec- or a software fault has essary.
  • Page 85 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions High respiratory rate!! MEDIUM Measured frequency Inhibition for 60 s on Check the suitability of above the alarm thresh- ventilation start-up. alarm level settings with old or automatic trigger- the ventilation settings ing of the inspiratory Inhibition during a...
  • Page 86 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions Batteries nearly dis- MEDIUM The available remaining Immediate Insert a charged, re- charged!!! Connect AC time for the internal bat- placement auxiliary bat- power. tery is low.
  • Page 87 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions HIGH Electronics failure Triggering during auto- Safety Ventilation!!! Re-run the automatic matic tests tests. Recommend switching ventilator If the problem persists: Use a different unit and contact your technical department Sounder failure!!! Venti- HIGH...
  • Page 88 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions High VTi!! MEDIUM Insufflated tidal volume Triggered after 3 con- Check the level of leak- above the set threshold secutive ventilation cy- cles with low VTi.
  • Page 89 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions Low respiratory rate! Measured frequency be- Check the suitability of Inhibition for 60 s on low the alarm threshold alarm level settings with ventilation start-up. the ventilation settings in progress.
  • Page 90 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions Ventilator operating on MEDIUM The machine is operat- Replace the auxiliary Immediate internal battery!! ing on internal battery battery or connect the machine to AC mains.
  • Page 91 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions CO2 concentration out MEDIUM Measured CO2 > 15% Immediate triggering If CO2 actually < 15% of tolerance then calibrate the probe. Calibrate the IRMA ™ MEDIUM Probe drift Immediate triggering Calibrate the probe.
  • Page 92 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions O2 mixer defect!!! Venti- HIGH Electronics failure Immediate triggering Set the FiO2 set-point = lation Effective to 21% Re-run the automatic tests with an O2 source.
  • Page 93 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions Excessive internal bat- HIGH Immediate triggering Use a different unit and Mean temperature of tery temperature! contact your technical internal battery: department - Discharging: above 75°C or below -40°C - Charging: above 70°C or below -20°C Excessive auxiliary bat-...
  • Page 94 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions High turbine tempera- HIGH High turbine tempera- Immediate triggering Check that the unit is ture!!! Ventilation poten- ture being used according to tial stop specifications Check the unit air inlet.
  • Page 95 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions High plateau pressure!! MEDIUM Immediate triggering Check the coherence of Plateau alarm levels with venti- lation settings. pressure greater than alarm threshold Incompatibility between MEDIUM VT target not reached 3 cycles Check the coherence VT target and settled...
  • Page 96 Monnal T60 Advanced - User manual Alarms Priority Alarm activation Alarm activation delay Actions High CC rate! Measured Inhibition for 60 s at Check the consistency ventilation of the alarm levels in re- cardiac lation to the start-up. massage rate greater...
  • Page 97 5 Alarms and other messages Alarms Priority Alarm activation Alarm activation delay Actions Low spontaneous RR!! MEDIUM Measured spontaneous Check the consistency Inhibition for 60 s when respiratory rate lower between the alarm lev- ventilation starts. than the alarm threshold els and the ventilation settings.

  • Page 98: Maintenance

    • Mikrozid universal wipes. Note: Any other equivalent disinfectant may be used as long as the product's manufacturer demonstrates its compatibility with Monnal T60 Advanced. CAUTION: Follow the instructions of the product's manufacturer. Surface cleaning and disinfection precautions CAUTION: Before the operation: •...

  • Page 99: Air Inlet Filter (Monnal Clean'in)

    6 Maintenance 6.3 Air inlet filter (Monnal Clean’In) The Monnal Clean’In HEPA air inlet filter must be checked and replaced regularly (every six months). To replace it, loosen and remove by turning anticlockwise. Insert the new filter and turn clockwise to secure the fit.
  • Page 100 Single-use version The expiratory assembly is delivered by Air Liquide Medical Systems clean and ready for clinical use. The exchange interval depends on hospital infection-control protocols, the presence of secretions and the nebulization of drugs. CAUTION: Reusing single-use accessories or consumables carries the risk of patient cross- contamination.

  • Page 101: Accessories

    KA017140 PSIMV mode Monnal T60 Advanced PRVC mode Monnal T60 Advanced KA017142 KA017139 PSIMV / PS-Pro / PRVC pack modes Monnal T60 Advanced KA017141 PS-Pro mode Monnal T60 Advanced Expiratory assemblies Single use Monnal Eva expiratory valve x5 (valve body and membrane)
  • Page 102 0.3 liter test lung (infant) KV103500 Filters Single use Bacteriological filters for inspiratory output x50 KV103300 Monnal Clean’In filter Monnal T60 Advanced(HEPA filter) KY691400 Articulated arms for patient circuits 1-m articulated arm with quick central fixation and rail support KB019200 (with collet fixture adjustment)
  • Page 103 7 Accessories Description Catalogue Number Autoclavable Adult accessories kit (for heating humidifier MR850) VD324900 Child accessories kit (for heating humidifier MR850) VD324800 Single use Optiflow nasal cannula (x20) VD341000 Sensor adapter and respiratory circuit kit for MR850 humidifier VD340900 Nebulization Single use Aerogen Solo international nebulizer According to...

  • Page 104: Regulatory Requirements

    Accessories from the Air Liquide Medical Systems catalogue or included in the accessories kit deliv- ered with the ventilator comply with these requirements. The use of accessories not recommended by Air Liquide Medical Systems releases Air Liquide Medical Systems from all liability in the event of an in- cident.

  • Page 105: Maintenance

    Access to maintenance is protected by a code. This code is provided to the qualified technician via a call to the hotline, following technical training by Air Liquide Medical Systems or their authorized representative. The ventilator counts two operational parameters: number of hours of ventilation, and number of hours that the machine is powered up.

  • Page 106: Cell

    Monnal T60 Advanced - User manual The internal battery must be replaced after 300 charging and de-charging cycles or two years (whichever is sooner); the battery must be replaced by a qualified technician. Contact the technical de- partment for further information.

  • Page 107: Technical Description

    9 Technical description 9 Technical description 9.1 Operation 9.1.1 Pneumatic system Ambient air intake PATIENT Patient O 2 LP Low-pressure oxygen inlet BALLOON Expiratory valve equipped (concentrator) with a membrane O 2 HP High-pressure O2 inlet(net- work, cylinder) Non-return valve Airway inspiratory pressure sensor Non-return valve...

  • Page 108: Ventilation Function

    Monnal T60 Advanced - User manual Note: The balloon and hot wire expiratory flow sensor can be replaced. Refer to the mainte- nance manual for more information. 9.1.2 Ventilation function The turbine (T) of the ventilator entrains ambient air via the Monnal Clean’In (HEPA) (F2) filter and pro- vides sufficient compression according to the patient’s flow requirement and the settings.
  • Page 109 Note: Because the machine consumes only the flow rate it needs to provide the correct mix- ture concentration, Air Liquide Medical Systems recommends that the low-pressure source should be set to its maximum flow rate. This will allow a wider range of possible FiO2 values.

  • Page 110: Co2 Monitoring

    Monnal T60 Advanced - User manual This sensor is a chemical cell where an electrolytic reaction occurs. The current produced is propor- tional to the partial 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, at 25°C (see Mea-...

  • Page 111: Performance And Characteristics

    9 Technical description 9.2 Performance and characteristics 9.2.1 Technical Characteristics 9.2.1.1 General specifications Dimensions (L x l x h) 29 x 25 x 11 cm Audible operating sound level 48 dB(A) at 1 m Weight Weight A: 3.7 kg Weight with two batteries: 4 kg Weight B: 20 kg Operating conditions Relative humidity...
  • Page 112 Monnal T60 Advanced - User manual 9.2.1.2 Alarm sound level Accuracy Priority Acoustic pressure level measured High ± 3 dB (A) Min : 62 dB (A) Max : 97 dB (A) Medium Min : 60 dB (A) Max : 87 dB (A)
  • Page 113 External DC source (ambulance, aeroplane, helicopter) Type Rated voltage: 13-24 VDC (tolerance: 11.1-30 VDC) Permissible voltage: 11.1V to 30V for use with the Monnal T60 Advanced power cable Maximum current: 11 A Cable type 2.5m Monnal T60 Advanced power cable (YR123700)
  • Page 114 Monnal T60 Advanced - User manual It is also necessary to carry out the automatic tests with the combination of all of the components of the ventilator's ventilation system foreseen for the patient and to obtain faultless test results. Patient circuit...
  • Page 115 9 Technical description Ventilator outlet bacteriological filter Filtration 99.99999% bacterial retention at 0.3 µm 99.9999% viral retention at 0.02 µm 9.2.1.5 Oxygen sensor specifications Lifespan Approximately 5000 h (variable time according to concentration and temperature) Conditions of storage and use Identical to those of the machine Power supply Supplied by the ventilator, including when operat-...
  • Page 116 Monnal T60 Advanced - User manual 9.2.1.6 Measurement parameters Flow rate and volume measurement condition: BTPS Measured parameters Mea- Reso- Precision Filtering sure- lution ment 0 - 100 ± (2 cmH 2 O + 4%) 15 ms Peak airway pressure...
  • Page 117 9 Technical description Measured parameters Mea- Reso- Precision Filtering sure- lution ment 55 - ±10% 4 s + 5 cycles Chest compression rate (fCC, bpm) 5 - 20 ± 4 cmH 2 O + 30% 5 cycles Maximum pressure variation (P-P, cmH 2 O) ±2s CPV timer...
  • Page 118 Monnal T60 Advanced - User manual Curves Volume (ml) Adjustable on successive scales: 0 to 100, 0 to 500, 0 to 1000, 0 to 3000 Instantaneous CO2 / Av- Adjustable on successive scales: erage CO2 concentration 0 to +50, 0 to +100...
  • Page 119 9 Technical description Trigger systems Inspiratory trigger system Primary inspiratory trigger is flow rate, secondary is pressure: The inspiratory trigger setting is between 0.5 and 10 L/min. A pres- sure threshold varying from 0.2 to 5 cmH O is correlated to the flow trigger.
  • Page 120 Monnal T60 Advanced - User manual High pressure (HP) and low pressure (LP) O inlets Standalone mode Cylinder (HP) Low flow O2 metered supply e.g. Concentrator (LP) Mixer Electronic, electrochemical O2 sensor Precision (% of set value) ± 5 percentage points under the conditions spec-...
  • Page 121 If this cannot be avoided, its operation under the conditions of use must be checked be- forehand. The use of accessories other than those specified or sold by Air Liquide Medical Systems as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the medical device.
  • Page 122 CAUTION: RF hand-held communication devices should not be used (including peripherals such as antenna cables and external cables) within a radius of 30 cm (12 inches) of any part of the Monnal T60 Advanced, including the cables specified by the manufacturer. Otherwise, the performance of this equipment may be impaired.
  • Page 123 9 Technical description Electromagnetic emissions The medical device is intended for use in an electromagnetic environment described in the table be- low. The user and installer must ensure that the medical device is used in the environment described below. Emission test Compliance Electromagnetic environment - com- ments...
  • Page 124 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 part of the Monnal T60 Advanced, including the cables specified by the manufacturer.
  • Page 125 9 Technical description Immunity test Test level Compliance level Electromagnetic environ- ment/comments Conducted disturbances, in- duced by radio-frequency fields (IEC 610004-6) 150KHz to 80MHz 150KHz to 80MHz 6 V ISM bandwidth and band- 6 V ISM bandwidth and band- widths between 0.15 MHZ widths between 0.15 MHZ and 80 MHZ, including ama- and 80 MHZ, including ama-...

  • Page 126: Settings Tables

    Monnal T60 Advanced - User manual 9.2.2 Settings tables Description Modes Name Unit Adult Child Infant min~max [de- res. min~max [de- res. min~max [de- res. fault] fault] fault] FiO2 FiO2 21~100 [50] 4 then 21~100 [50] 4 then 21~100 [35]...
  • Page 127 9 Technical description Description Modes Name Unit Adult Child Infant min~max [de- res. min~max [de- res. min~max [de- res. fault] fault] fault] Respiratory rate c/min 6~28 [15] (ROSC phase) RR support PS-Pro RR sup- c/min 5~40 [15] 5~60 [25] 1~80 [40] port Expiratory pres- (A)VCV,...
  • Page 128 Monnal T60 Advanced - User manual Description Modes Name Unit Adult Child Infant min~max [de- res. min~max [de- res. min~max [de- res. fault] fault] fault] Plateau time (A)VCV, Tplat 0~60 [23] 0~40 [38] 0~40 [0] (A)VCV NIV, VSIMV Plateau time...
  • Page 129 9 Technical description Description Modes Name Unit Adult Child Infant min~max [de- res. min~max [de- res. min~max [de- res. fault] fault] fault] Peak flow (A)VCV, Flow L/min 4~150 [28] 4~150 [15] 2~150 [4] (A)VCV rate NIV, VSIMV TI/Ttot (A)VCV, TI/Ttot 10~50 [33] 10~50 [33] 10~50 [33]...
  • Page 130 Monnal T60 Advanced - 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 cmH O + 4%) •...

  • Page 131: Calculation Of Predicted Body Weight

    9 Technical description 9.2.3 Calculation of predicted body weight Height Predicted body weight (kg) (1) Category Inch Female Male Infant Child Adult (1) Predicted weight based on: • Height <= 84 cm: WHO child growth standards • 84 cm < Height <=144 cm:...

  • Page 132: Interdependency Of Settings

    Monnal T60 Advanced - User manual Adults and Pediatrics. Peck Formula. Tech. Report. 10. Div. Clin. Pharmacol. Uniformed Services Uni- versity of the Health Sciences. Predicted weight (man) = 59.6035 + [5.2878 x height] - [0.1239 x height2] + [0.0013 x height3] Predicted weight (woman) = -77.5580 + [6.9373 x height] - [0.1717 x height2]+ [0.0017 x height3]...

  • Page 133: Alarm Threshold Settings

    9 Technical description 9.2.5 Alarm threshold settings Thresh- Ventilation modes Set- Adult Child Infant old (name) ting Min~Max [default] High pres- Volumetric modes: 10~80 [45] sure (Ppeak) (A)VCV Pressure-con- max value (10 or PI + 5)~80 [45] trolled modes: (A)PCV, PSV, CPAP, VSIMV, APRV, PSIMV, PRVC, PS-Pro 10~80 [60]...
  • Page 134 Monnal T60 Advanced - User manual Thresh- Ventilation modes Set- Adult Child Infant old (name) ting Min~Max [default] ECLS activated max value (50 or max value (50 or low VTe threshold + low VTe threshold + 50) ~ 3,000 [2,000]...

  • Page 135: Automatic Alarm Thresholds

    9 Technical description Thresh- Ventilation modes Set- Adult Child Infant old (name) ting Min~Max [default] High Chest 110~140 [120] Not available Compression Frequency (fCC) Maximum pres- Not adjustable Not available sure variation of chest com- pressions (P-P) 9.2.6 Automatic alarm thresholds This table shows the calculation of the alarm threshold values when Auto.

  • Page 136: Recovery Of The Components Of The Medical Device

    Monnal T60 Advanced - User manual Thresh- (A)VCV (A)PCV PSIMV VSIMV CPAP APRV PRVC PS-Pro (name) High Measured MVe + 50% Low MVi Measured MVi - 50% Measured MVi - 50% Not applicable in NIV Not applicable in NIV High...
  • Page 137 Shipping equipment Air Liquide Medical Systems recommends that the user keep the original packaging. If the medical device is returned, always use the original packaging. Otherwise, contact your Air Liquide Medical Systems representative to obtain replacement packaging. 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.

  • Page 138: Regulatory Requirements

    Life time of the Monnal T60 Advanced ventilator: 10 years. Standards The compliance of Monnal T60 Advanced with the essential requirements of Directive 93/42 is based on the following standards: EN ISO 14971 Application of risk management to medical devices IEC 60601-1 and its amendments | Electromedical devices –...

  • Page 139: Appendix

    10 Appendix 10 Appendix 10.1 Checklist When a device is commissioned and after any maintenance operation, carry out the sequence of ac- tions below: Done Connect the unit to the O2 wall outlet or an oxygen cylinder. Check that the supply pressure is correct (between 2.8 and 6 bar). Install the patient circuit on the machine and connect a test lung.

  • Page 140: Maintenance Data Sheet

    Monnal T60 Advanced - User manual 10.2 Maintenance data sheet...
  • Page 141 Pre-disinfection / cleaning Immerse the expiratory assembly components in a pre-disinfectant solution. Note: Air Liquide Medical Systems recommends the use of products: neodisher Multi- Zym, Anios Clean Excel D (obey the instructions of the product manufacturer). Rinse the parts under running water, except for the expiratory flow sensor (1), which should only be dipped in water.
  • Page 142 Monnal T60 Advanced - User manual Note: A unique serial number on the expiratory flow sensor (1) and the valve body (2) gives the date of manufacture of the components and can be used to track the number of cycles they have undergone.
  • Page 143 V1.1.xI4 UM000174 Air Liquide Medical Systems S.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...

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