Contents Before use .......................7 1.1. Definitions of user warnings ......................7 1.2. Intended use ..........................7 1.3. Training ............................7 1.4. Brief description of the device .......................8 1.5. Symbols and markings on the device .....................9 1.6. General safety instructions ......................11 2. Description of the device ..................14 2.1. Terminology Used ........................14 2.2. Front view ............................14 2.3. Right-hand side: Patient circuit connection panel ................15 2.4. Left-hand side: Turbine air inlet panel ..................15 2.5. Rear panel ...........................15 3. Installation and commissioning ................16 3.1. Unpacking ...........................16 3.2. Connections and commissioning ....................16...
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Monnal T60 4.9.11. PRVC (Pressure-Regulated Volume Controlled) ......................43 4.9.12. PS-Pro (Pressure Support - Pro) ............................. 44 4.9.13. PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation) ..........45 4.10. C PV: Cardio-Pulmonary Ventilation .....................46 4.11. O xygen therapy ...........................48 4.12. CO option ...........................49 4.13. K eeping alarm settings and thresholds ..................50 4.14. D isplaying the curves ........................52...
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5.7. Table of alarms ..........................76 6. Maintenance ......................87 6.1. Definitions ...........................87 6.2. Routine Maintenance ........................87 6.3. Bacteriological filter ........................87 6.4. Air inlet filter (Monnal Clean’In) ....................88 6.5. Expiratory assembly: Flow sensor + expiratory valve ..............89 7. Accessories ......................91 7.1. Regulatory requirements ......................91 7.2. Items included in the package .....................92 7.3. List of options and accessories ....................93 8. Maintenance ......................96 8.1. By the user ..........................96 8.2. By the technician .........................96 8.3.
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Monnal T60 ventilation” ......................................138 10.3.4. Alarm N°006: “Ventilation Interrupted!!! Use an alternative ventilator” ..............139 10.3.5. Alarm N°021: “PEEP greater than PEEP set-point + 5 cmH2O!!!” ................140 10.3.6. Alarm N°008: “Patient disconnection!!!” ........................141 10.3.7. Alarm N°044: “Expiratory flow measurement inoperative!!!” ...................142 10.3.8. Alarm N°113: “Slight leak detected during automatic tests!” .................143 10.3.9.
Monnal T60 is a standalone ventilator using air (pro- hospital department by Air Liquide Medical Systems pelled by a blower) used to treat infants (3 kg and staff or by an authorized Air Liquide Medical Systems above), children, and adults. It is not intended for neo- distributor.
Monnal T60 1.4. Brief description of the device Monnal T60 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. It can also supply FiO from 21 to 100%. This is contin- uously monitored. It features the following ventilation modes and func-...
Before use 1.5. Symbols and markings on the device Weight and rated output of product Expiratory valve eject button Weight of complete system (Mon- nal T60, mobile stand, articulated arm, Weight of Monnal T60 device interchangeable battery and patient circuit) Manufacturer High pressure oxygen inlet fitting Device Catalogue Number Low pressure oxygen inlet fitting Serial Number of the device Patient circuit inspiratory fitting Date of manufacture: YYYY-MM Patient circuit expiratory fitting...
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Monnal T60 Specific symbols for IRMA™ CO measurement probe Protection Index according to the EN 60529 standard 4: protection from the penetration IP44 Type BF device of solid bodies of diameter ≥ 1 mm. 4: protection from water splashing from any direction YL180117 - Rev. 9D - 2020-03...
• When the device is not in use, it is recommended that you disconnect all oxygen sources from it. Use with a defibrillator • When using the Monnal T60 and a defibrillator simultaneously, the defibrillation shock in the presence of enriched oxygen and combustibles (such as textiles) can cause an explosion or fire which could injure the patient and bystanders.
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• The device and its accessories (masks, circuits, etc.) are Latex-free. • The air inlets located at the back and side of the device must be completely unobstructed. • To operate the device from ambient air, a Monnal Clean-In (HEPA) filter must be used at the ventilator inlet. This filter is recommended by Air Liquide Medical Systems. • Do not use the ventilator in an explosive or nicotine-laden atmosphere (cigarette smoke, fire, etc.). • In order to prevent dust from entering: • between ventilator uses in the bag, close the inspiratory limb cap;...
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• The device must not be subjected to violent impact. • Use the carry bag recommended by Air Liquide Medical Systems only. • During transport, the use of Monnal T60 outside of its bag does not ensure compliance with EN 13718-1, EN 1789 and EN 794-3 standards.
Monnal T60 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 1. Handle • To carry the machine easily. 2. Touch screen (8.4 inches) Interface between the user and the device • Permits adjustment of all ventilation settings.
Monnal T60 3. Installation and commissioning 3.1. Unpacking Remove the ventilator from the packaging and place it horizontally on a table. Left-hand side: Unwrap the accessories supplied with the ventilator. Location of power cable with Anti-pull cable protection clip Before using on a new patient, and before the first use of this device, you must clean and disinfect the accessories (see section “6 Maintenance”).
(1). It must be placed on the Y-shaped part(4). Air Liquide Medical Systems recommends using the patient circuits listed in Chapter “7.3 List of options and accessories”. If not, the use of patient circuits containing phthalates or bisphenol A poses risks for pregnant women, lactating women and children.
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, • the CO probe for measuring the concentration of exhaled carbon dioxide (in accordance with ISO 80601-2-...
Installation and commissioning 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 etCO monitoring block is displaying data. 3. Connect the IRMA™ probe, equipped with its adapter, to the Y-piece on the patient circuit (c). 4. Connect the IRMA™...
Monnal T60 3.2.8. Applying power Do not obstruct the vents located on the left- and right-hand sides of the device and underneath it, as this could compromise patient safety. Apply power to the device using the ON/OFF button located on the left-hand side of the unit (see opposite).
Without these tests, the precision of ventilation param- eters and measurements cannot be guaranteed. Air Liquide Medical Systems therefore recom- mends the running of these automatic tests before each use on a patient. 1. To launch the automatic tests, press the Automatic tests key.
Monnal T60 4. Use This ventilator is controlled mainly via the touch screen and the control wheel. Avoid using any object that might scratch the screen. 4.1. Start-up screen This screen is displayed when the machine starts up. The display zone (green band) says ‘Unit on stand- by’.
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9 10 Zone to define the patient characteristics. See 11 Alarm banner: Alarm display and software ver- section “4.5 New patient”. sion zone Emergency ventilation access key in VC mode. Key to access 100% O in PSV non-invasive 12 Day / Night key (brightness setting) ventilation (NIV) mode Key to access other available Ventilation Modes 13 Screen lock key Zone to define the category of patient to be 14 Automatic test launch key...
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Monnal T60 Screen - CPV option enabled If the CPV option is enabled, the ventilation mode is displayed on the home page, as shown here. Key to access CPV mode YL180117 - Rev. 9D - 2020-03...
4.2. Ventilation screen Display of the time elapsed since a ventilation Display curves (1 to 8 configurable) mode was first activated. The counter resets to zero for each new patient, and after 18h ventilation. The counter display turns red after one hour’s ventilation. Monitored ventilation parameters Ventilation settings 100% O Arrow to access the rest of the settings for the current ventilation mode Trends access key...
Monnal T60 4.3. Home screen (current ventilation) This screen is displayed when you press the Home key. It is the same as the start-up screen, but it keeps the ventilation-related functions: settings and monitored parameters. Ventilation continues. The current ventilation settings are maintained...
4.4. Ventilator controls Function buttons Each function is activated by pressing the appro- priate key. Its activation is indicated by a yellow LED. Press again to deactivate the function: the yellow LED is OFF. Ventilation settings Settings of each more are entered or modified by pressing the screen. The value is highlighted. To change the value, turn the control wheel and con- firm by pressing the control wheel.
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Monnal T60 Validation and information box This dialog box informs the user of the inter- action between the parameters when they are being adjusted, or asks for confirmation for an action. Alarm header panel The alarm header panel shows the alarm sta- tus and level. Its color changes depending on the importance: red, yellow, cyan, green (in de- creasing order of importance).
4.5. New patient For the safety of the patient and to optimize ventilation performance, the patient characteristics should be appropriate to the patient being ventilat- 4.5.1. Selecting the patient category The choice of patient category allows adaptation of each of the following elements to the condition of the patient: • Initial values of ventilation parameters and alarms, • Ventilation parameter and alarm adjustment rang-...
Monnal T60 4.5.2. Selecting the patient height and gen- The choice of height and gender enables the default volume supplied to the patient in emergency Vol- ume-Controlled (VC) Ventilation mode to be adjusted and the predicted Weight/VT coefficient to be shown in the help window for setting volume modes. To enter the height, press the “Height” button, turn the control wheel to change the value, and press the con- trol wheel to confirm the highlighted option.
4.6. Emergency ventilation start-up For requirements arising in critical emergency situ- ations, Monnal T60 allows you to launch ventilation from the start-up screen with predefined ventilation parameters. The proposed emergency ventilation mode is Volume Controlled Ventilation. As advised by clinicians, the fol- lowing applications could be considered for the modes available.
Monnal T60 4.7. Start / stop ventilation The various ventilation modes are accessible via the start-up screen using the Ventilation Modes key. The following modes are available: • (A)VCV; (A)VCV / NIV • (A)PCV; (A)PCV / NIV • PSV; PSV / NIV • CPAP • SIMV; SIMV NIV In option: • Duo-Levels...
4.8. Shutting down the unit There are two ways to shut down the unit from the stand-by screen: → Press the Shutdown key; • press the control wheel to confirm or press Cancel From the stand-by screen to cancel the shutdown. → Press the ON/OFF button (left-hand panel of the Using the ON/OFF button unit), for more than 10 seconds, • press the control wheel to confirm or press Cancel to cancel the shutdown.
Monnal T60 4.9. Ventilation modes 4.9.1. Mode selection From the ventilation, start-up, or home screen: From the start-up screen or home screen (ventila- tion in progress): • Press the Ventilation Modes key, • Press the desired ventilation mode, • The corresponding yellow LED lights up, • Press the Validate key. From the ventilation screen See “4.4 Ventilator controls”. 4.9.2.
For safety reasons, apnea ventilation should only be deactivated when the clinical situation so permits. Air Liquide Medical Systems recommends activating apnea ventilation Ideally, the apnea ventilation adjustment should be performed before starting ventilation.
Monnal T60 4.9.4. VCV (controlled ventilation or assisted volume-controlled ventilation) [VCV = Volume-Controlled Ventilation] Principle VCV mode is used to control the tidal volume delivered to the patient on inspiration and the frequency of the ventilation cycles. During expiration, the ventilator regulates the pressure in order to maintain the set PEEP level.
4.9.5. PCV (controlled ventilation or assist- ed pressure-controlled ventilation) [PCV = Pressure-Controlled Ventilation] Principle PCV mode is used to control the pressure delivered to the patient, the inspiration time, and the frequency of the ventilation cycles. During expiration, the ventila- tor regulates the pressure in order to maintain the set PEEP level.
Monnal T60 4.9.6. PSV (spontaneous ventilation with inspiratory assistance and PEEP) [PSV = Pressure Support Ventilation] Principle A constant positive pressure is maintained above PEEP level in the patient circuit 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 maximum set insufflation time is reached (TImax).
4.9.7. SIMV [SIMV = Synchronized Intermittent Mandatory Ventilation] Principle SIMV Mode combines mandatory assisted controlled ventilation and pressure supports spontaneous patient ventilation between the controlled cycles. Set-points Inspired oxygen fraction Tidal volume (mL); RR SIMV Determines the frequency of the mandatory cycles (bpm); PEEP Positive end of expiration pressure (cmH Tins Determines the inspiratory time of the mandatory cycles (bpm);...
Monnal T60 4.9.8. PSV / NIV (non-invasive ventilation) [NIV = Non Invasive Ventilation] Principle NIV is initiated by pressing the Non invasive key. NIV mode allows you to ventilate a patient via a non-airtight interface: eg. Facial, oral, nasal mask or a NIV headset. For this reason, the range of the ventilation settings and alarm thresholds ranges are adapted to NIV, i.e.: • The PEEP set-point is limited to 15 cmH...
4.9.9. CPAP (Continuous Positive Airway Pressure) [Continuous positive airway pressure] Principle In CPAP mode, the ventilator regulates the pressure in the airways to the set CPAP value. The patient breathes spontaneously through the device in this mode of operation. Set-points Inspired oxygen fraction Continuous Positive Airway Pressure CPAP (cmH ...
Monnal T60 4.9.10. Duo-Levels (Alternation of two CPAP levels) Principle Duo-Levels mode is characterised by pressure-controlled ventilation combined with the patient having the abil- ity to breathe spontaneously throughout the cycle. Duo-Levels mode is used to maintain a constant pressure (PI) for a time T high, and then a lower pressure (PEEP) for a time T low.
4.9.11. PRVC (Pressure-Regulated Volume Controlled) Principle PRVC mode is a pressure-regulated ventilation mode that guarantees the volume delivered to the patient. The ventilator automatically adapts the inspiratory pressure delivered so that the monitored Vti is equal to the set VT Target. The adaptation interval of the PI is between 0.1 cmH O and 3 cmH O.
Monnal T60 4.9.12. PS-Pro (Pressure Support - Pro) Principle The PS-Pro mode is a PSV-type pressure-regulated ventilation whose assistance frequency evolves automat- ically between two set frequencies: RR min and RR support (minimum frequency and maintained 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 his or reflexes are inactive.
4.9.13. PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation) Principle PSIMV Mode combines mandatory assisted pressure-controlled ventilation and spontaneous patient ventila- tion between the assisted controlled cycles. Set-points inspired oxygen fraction; inspiratory pressure (cmH RR SIMV determines the frequency of the imposed cycles (bpm); PEEP positive end of expiration pressure (cmH Tins inspiration time of intermittent controlled assisted cycles (s);...
Monnal T60 4.10. CPV: Cardio-Pulmonary Ventilation Principle and therapeutic indication The CPV function is a solution for assisting ventilation with ADULT patients in cardiac arrest. It combines ventilation, monitoring and functionalities specifically for cardiopulmonary resuscitation. The CPV function has two ventilation phases: • the “chest compression” phase, enabling compressions to continue with appropriate ventilation and moni- toring • the “ROSC”...
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ROSC phase set-points fraction of oxygen inhaled minimum respiratory rate (b) PEEP Positive exhalation pressure (cmH Insufflation pressure (cmH Trig.I Inspiratory Trigger (L/min or O or OFF) Operation Chest compression phase At the start of the CPV function, the “Chest compressions” phase is enabled, and remains so until the key is pressed. Detection of the first chest compressions is confirmed by the sound of 5 audible beeps.
Monnal T60 To access the CPV Report, see section “4.15.5 Monitoring screen”. Use the knob to browse the list. When the memory capacity of the log is full, the oldest entries will be re- placed by the new entries. Airway Opening Index (AOI) Percentage of the opening of the airway, based on the measurement of instantaneous CO .
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. Use only IRMA™ probes sold by Air Liquide Medical Systems: Cat. No. KB020400 •...
Monnal T60 4.13. Keeping alarm settings and thresholds When changing ventilation mode, and depending on the case, the alarm settings and thresholds can be kept or discarded. There are 3 scenarios: Oxygen therapy When an oxygen therapy session is started, the settings and thresholds for this function are applied, and no longer take the settings from the previous mode into account.
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Other modes When switching from one ventilation mode to another (not including emergency modes and oxygen therapy), the setting and threshold values are kept. For settings and thresholds that are not shared by the two modes (i.e. VT in pressure-controlled mode), the values are stored in memory but are not applied. In this example, a pressure-controlled mode (PSV) follows a volume-controlled mode (AVCV): AVCV AVCV...
Monnal T60 4.14. Displaying the curves Eight curves are available: Pressure, flow rate, volume, Curve menu pressure / volume, flow rate / pressure, volume / CO and CO (if the etCO software option is enabled). Two curves are displayed continuously and in real time. Only one is displayed in the case of loop curves. To change the curve display, press the area of the curve to be replaced and select the desired curve from the menu on the right.
4.15. Monitoring Several monitored ventilation parameters (measure- ments) are available for each ventilation mode. Each parameter displays the value of the measure- ment for the current ventilation mode. These values are accessible on two pages using the arrow . Six measurements per page are continuously dis- played on the screen, six on the clinical screen, and four on the waveform monitoring screen.
Monnal T60 4.15.1. Adjustment of alarm thresholds The alarm thresholds can be accessed and adjusted directly via the ventilation screen. To adjust a threshold: • Select the value to be adjusted, upper or lower threshold of the desired block. The value is highlight- Monitored respiratory parameters • Adjust the value by turning the control wheel, and...
4.15.2. Automatic thresholds The Auto. set button is used to automatically config- ure all of the alarm thresholds according to the values measured at the time when the button is pressed (see “9.4.8 Alarm thresholds”). To adjust the automatic thresholds, press a monitor- ing block. The Auto. set button appears on the right- hand side of the screen.
Monnal T60 4.15.3. Display of measurements List of measured parameters (those with alarm thresholds must be present) on two pages: Measurements Type of information Insufflated oxygen fraction measured every second Volume exhaled during the cycle Respiratory rate averaged over 4 cycles Ratio of inspiration time to total cycle time...
4.15.4. Trends This function allows the user to track the following Access to trends from the ventilation screen measured ventilation parameters: • CO • VTe • MVe • Ppeak • PEEP • Pmean • RR • TI/Ttot • FiO • Pplat • VTi • Leak • P-P * • RR CC * • % CC* • AOI * * (if the CPV software option is activated) This screen can display two trend curves at the same...
Monnal T60 4.15.5. Monitoring screen The Monitoring screen key lets you increase the Monitoring screen key curve display area. When this function is enabled: • The ventilation settings are no longer displayed, and are replaced by the curve Freeze, Inspiratory pause and Expiratory pause functions.
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Inspiratory pause The Inspiratory pause key is used to perform an in- spiratory pause (limited to 40 seconds). The pause continues for as long as the user holds down the key. When the user stops the hold, the ventilator resumes ventilation with the parameters set previously. Expiratory pause The Expiratory pause key is used to perform an ex- piratory pause (limited to 60 seconds).
Monnal T60 4.16. Menu 4.16.1. Description The Menu key is on the right, at the bottom of the screen. It gives access to functions or commands via a two-level structure. The menu is accessible via the start-up, ventilation, and stand-by screens.
4.16.2. Menu structure Patient monitoring History Trends CPV report Sensors monitoring (ON/OFF) etCO monitoring (ON/OFF) Exp monitoring (ON/OFF) sensor calibration Low-pressure O ON/OFF Configuration Alarm sound volume Brightness Alarm flash (ON/OFF) Alarm inhibition (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)
Monnal T60 4.16.3. Sensors This key is used to enable or disable monitoring. Three monitoring sensors can be selected or de-se- lected: • FiO monitoring • etCO monitoring • Expiratory flow monitoring. To enable a sensor: • Press the Menu key, • Press the Sensors key, • Press the desired sensor to enable it (yellow LED).
4.16.4. Low-pressure O This function allows the machine to enrich the O mix- ture from a low-pressure source, typically a low flow meter on an O cylinder or a concentrator. This is different from connecting it to a high-pressure source, as it involves lower quantities (pressure gen- erally below 1 bar, flow less than 10 L/min); According to the nature of the source and the ventilation settings, certain FiO values cannot be guaranteed.
Monnal T60 4.16.5. Patient monitoring The “Patient monitoring” function is for accessing the patient’s data such as History (see section V.6), Trends (see section 4.15.4) and the CPV report (see section 4.10). The trends can also be accessed via the ventila- tion, start-up, and stand-by screens (see the screen diagram opposite).
4.16.7. Configuration of the ventilator Press the Menu key: the list of menu parameters is displayed. Press the Configuration key. Volume To adjust the device’s audible alarms: • Press the Volume key, • Turn the control wheel to display the desired value, • Press the control wheel again to validate. The audible alarm is for a health professional near the patient.
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Monnal T60 Alarm flash The Alarm flash function allows you to enable the presence of the casing indicator light on the front pan- el of the machine. → Press the Alarm flash key to activate the function: a yellow LED is displayed (this function is enabled by default).
4.17. Other functions 4.17.1. 100% O The 100% O key (62) allows you to set FiO automat- ically to 100%. After two minutes or a second press of the key, FiO returns to its initial value. In case of use with a low flow supply, FiO not reach 100%.
Monnal T60 4.18. Personalizing the device All of the machine settings described below are ac- cessible in stand-by via the configuration menu (press the control wheel and press the sound inhibition key). Ventilator Home screen first button Home screen second button Activate options Patient Weight/VT coeff. (mL/kg) SI units Size unit Protocol...
4.18.1. Default patient The Default patient function is used to choose the type of patient (adult, child, or infant) selected by de- fault on device start-up. The default patient is ADULT. This is accessed from the “Ventilator” tab, then “Pa- tient”. If the “Patient sett. back-up”...
Ventilator menu. 4.18.7. Choice of communication protocol This function allows you to select the protocol used for transmitting data from the Monnal T60. See “9.3.3. Connectivity to hospital networks”, page 104. 4.18.8. Display of the ventilation timer This function allows you to enable or disable the dis- play of the ventilation timer.
4.18.10. Saving the ventilation settings and 4.18.12. Display of the monitoring blocks alarm thresholds The Monitoring function allows the user to change the display order of the monitoring blocks in the clini- Settings can be saved for each category and each cal display (measures clinic screen) and in the mon- type of ventilation: itoring display (measures wide screen). The configu- • Invasive ventilation rations are independent between the screens.
Monnal T60 5. Alarms and other messages In some circumstances, Monnal T60 warns the user that action is required using audible and visual alarms. Monnal T60 can also display information messages on the screen. There are 5 categories of alarms and messages: • Info category: information messages;...
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Alarms and other messages Simultaneous alarms display The arrow indicates that several alarms are active at the same time: Press on the arrow to display all the active alarms: In cases where two (or more) alarms of the same priority are triggered at the same time, the alarm with the lowest No.
Monnal T60 5.2. Alarm Acknowledgement Certain alarms open a dialog box. These are ‘acknowl- edgeable’ alarms, which are specifically intended to inform the user of a particular event. A stand-by request or switching to internal battery are examples of acknowledgeable alarms. The user must confirm using the control wheel; the dialog box then...
Alarms and other messages 5.4. Preventive alarm inhibition Holding down the alarm inhibition key inter- rupts the alarms for 2 minutes. On the screen, the panel shows “Alarm inhibited”. A counter next to the alarm inhibition key shows the re- maining activation time. If there is an alarm during this time, the alarm mes- sage displays on the screen.
Monnal T60 5.7. Table of alarms Alarm Alarm Alarms Priority Actions activation activation delay * Press the control wheel to stop Device Immediate ventilation. switched to STANDBY mode? MEDIUM triggering Press ‘Cancel’ to maintain Stand-by Mode ventilation. Press the control wheel to shut down Immediate the unit.
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Alarms and other messages Alarm Alarm Alarms Priority Actions activation activation delay * Ventilation Check and amend the settings if settings are necessary. not technically Immediate Contact your technical department if Incorrect Set- HIGH tings!!! achievable, or a triggering the problem persists or is recurrent. software fault Ventilation continues but the new has occured...
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Monnal T60 Alarm Alarm Alarms Priority Actions activation activation delay * Inhibition for 60 s on ventilation start- Measured fre- quency above Check the suitability of alarm level Inhibition during a the alarm thresh- settings with the ventilation settings pause and 30s after High respiratory...
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Alarms and other messages Alarm Alarm Alarms Priority Actions activation activation delay * Battery charger The battery char- Triggering within Use a different unit and contact your ineffective!!! Ven- HIGH ger is faulty. 10 s technical department tilation Effective No patient respi- ratory activity for T Apnea Check patient safety and verify the Apnea ventila-...
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Monnal T60 Alarm Alarm Alarms Priority Actions activation activation delay * Triggered when the measured fan speed Error detected!!! Cooling fan oper- has been zero or too Replace the cooling fan Contact the tech- HIGH ating failure nical department. slow for more than 5 seconds...
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Alarms and other messages Alarm Alarm Alarms Priority Actions activation activation delay * Inhibition for 60 s on ventilation start- Measured fre- Check the suitability of alarm level Inhibition during Low respiratory quency below the settings with the ventilation settings rate! a pause and 30 s alarm threshold in progress.
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Monnal T60 Alarm Alarm Alarms Priority Actions activation activation delay * Immediate trigger- None ing when ventilation Unit on stand-by Unit on stand-by (INFO cate- shuts down or when gory) unit is started up Press the control wheel to confirm None Press the 180°...
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Alarms and other messages Alarm Alarm Alarms Priority Actions activation activation delay * Electronics Set the FiO set-point = 21% mixer defect!!! failure Immediate Ventilation Effec- Use a different unit and contact your HIGH Inhibit if FiO set- triggering tive to 21% technical department point = 21% supply Immediate Check pressure in supply network or High oxygen supply pressure...
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Monnal T60 Alarm Alarm Alarms Priority Actions activation activation delay * Power supply Immediate Use a different unit and contact your Excessive PCB sup- PCB temperature HIGH ply temperature! triggering technical department above 95°C Correct voltage at internal battery Internal battery terminals, but...
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Alarms and other messages Alarm Alarm Alarms Priority Actions activation activation delay * Inspiratory CO Immediate Check ventilation settings and dead Rebreathing de- above threshold MEDIUM tected! triggering space in the patient circuit. (4 mmHg) IMMEDIATELY replace the DC input 10 s during which machine’s power supply unit DC input voltage voltage greater the fault is...
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Monnal T60 Alarm Alarm Alarms Priority Actions activation activation delay * Check the consistency of the Measured car- Inhibition for 60 s alarm levels in relation to the car- diac massage at ventilation diac massage rate. Low CC rate! rate below the start-up.
6.2. Routine Maintenance The surface of the ventilator can be cleaned. Air Liquide Medical Systems recommends the use of Schülke mikrozid universal wipes, ANIOS TSA, or ANIOS SURFA’safe products. It is important to follow the instructions of the product manufacturer, and not to allow any liquid to penetrate inside the unit.
Monnal T60 6.4. 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. Monnal Clean’In (HEPA) filter The Monnal Clean’in filter may not be disinfected, cleaned, or sterilized. The filtration characteristics of the Monnal Clean’In HEPA air inlet filter are: Characteristics Reference KY691400 Resistance at 60L/min 1.15 mbar Filtration 99.97% Particles > 0.5µm YL180117 - Rev. 9D - 2020-03...
Cat. No. Batch No. Single-use version The expiratory assembly is delivered by Air Liquide Medical Systems clean and ready for clinical use. The ex- change interval depends on hospital infection-control protocols, the presence of secretions and the nebuliza- tion of drugs.
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• Avoid impacts or dropping it. Pre-disinfection / cleaning 1. Immerse the expiratory assembly components in a pre-disinfectant solution. Air Liquide Medical Systems recommends the use of products: neodisher MultiZym, Anios Clean Excel D (obey the instructions of the product manufacturer). 2. Rinse the parts under running water, except for the expiratory flow sensor (1), which should only be dipped in water.
European direc- tive 93/42/CEE, as well as EN 60601-1 and collateral standards. Accessories from the Air Liquide Medical Systems catalogue or included in the accessories kit delivered with the ventilator comply with these requirements.
Accessories 7.3. List of options and accessories Some of the items mentioned below may not be available in every country. Contact your Air Liquide Medical Systems reseller for more information. Description Catalogue Number Capnography option etCO software option KA010700 IRMA™ CO probe KB020400 Single use IRMA™...
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Monnal T60 Single use Non-vented full-face mask size S KM222100 Non-vented full-face mask size M KM222200 Non-vented full-face mask size L KM222300 Autoclavable Non-vented full-face mask size S KM218800 Non-vented full-face mask size M KM218900 Non-vented full-face mask size L...
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Accessories Horizontal rail arm length 30.5 cm KA016700 Horizontal rail double arm length 30.5 x 30.5 cm KA016800 VESA plate interface (100x100) MT60 for articulated arm KA016400 Fixing and transfer systems Carry bag KF007800 Coyote bag KA013400 Coyote bag trolley KA013500 Wall-mounted charging station KA010300 Kit for wall-mounted charging station KA011100...
Air Liquide Medical Systems holds available to training by Air Liquide Medical Systems or their autho- maintenance staff a maintenance manual containing rized representative. The ventilator counts two opera-...
Maintenance 8.3. O Cell sensor location The life time of the O cell is approximately 5000 hours, but this can vary according to the oxygen con- centration used and the ambient temperature. • To open the compartment, turn and loosen the hatch.
Technical description 9.1.2. Ventilation function Obstruction management In the event of an obstruction in the expiratory branch, The turbine (T) of the ventilator entrains ambient air the solenoid valve V4 opens, which depressurizes the via the Monnal Clean’In (HEPA) (F2) filter and provides patient’s airways. The ventilation continues with zero sufficient compression according to the patient’s flow PEEP.
Note that this secondary internal battery does not tration, Air Liquide Medical Systems recommends that power any ventilation modes. the low-pressure source should be set to its maximum An alarm is triggered when this battery runs low and flow rate.
Technical description 9.2.2. AC power supply Full battery charge The presence or absence of AC power or the external DC supply is indicated by two symbols: Comfortable battery charge Mains present Medium battery charge Mains absent Battery low—connect the unit to the mains power supply. Presence of the mains (AC supply) is also indicated For the internal battery, the pictogram by a blue LED on the front panel of the machine.
Monnal T60 When operating the device at very high or low temperatures an alarm may be triggered “Exces- sive Battery Temperature”. This is a safety feature of the battery charging system and may interrupt the charging and discharging process of the battery, this can significantly affect the charging time and autono- my of the battery.
Technical description 9.3. Inputs and outputs 9.3.1. Video output The video output is located on the side of the machine where the handle is situated. A remote screen can be connected via this output in order to display an image of the ventilator screen. 9.3.2.
IP protection is no longer guaranteed. When clean- ing, it is necessary to replace the USB cover to pre- vent liquid from getting into the ventilator. Air Liquide Medical Systems protocols Monnal T60 has the following Air Liquide Medical Systems communication protocols: • OTP • Monnal Link These protocols are available on request.
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Technical description Compatible communication modules Contact Air Liquide Medical Systems to obtain the full list of communication modules compatible with Monnal T60. A hospital network failure can result in no data being transmitted (alarms and monitoring) to the external system. Connection to a hospital network supplying other units could give rise to previously unidentified risks to patients, operators or third parties.
IEC 60601-1-2 | Medical electrical equipment - Part Shipping equipment 1-2: General requirements for basic safety and essen- Air Liquide Medical Systems recommends that the tial performance - Collateral standard: Electromagnet- user keep the original packaging. ic compatibility - Requirements and tests...
Technical description 9.4.3. Technical Characteristics 9.4.3.1. General specifications Dimensions (L x w x h) 29 x 25 x 11 cm 3.7 kg Weight 4 kg with two batteries Audible operating sound level 48 dB(A) at 1 m Operating conditions On the mains: -20°C to +40°C (-4°F to +104°F) Temperature On batteries: -10°C to +40°C (14°F to +104°F) Relative humidity...
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Monnal T60 9.4.3.3. Electrical specifications Main Power Supply Input voltage 100 - 240 V AC (tolerance -25%; +15%) Frequency 50 to 60 Hz Electrical power consumption 120 VA max. (0.12 kW) Electrical class Type Leak current IEC 60601-1 compliant Protection following a loss of power Continuous audible alarm and patient vented to atmosphere 2-point mains cable having max.
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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, including the cables specified by the manufacturer. Otherwise, the performance of this equipment may be impaired.
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Monnal T60 Recommended separation distances The medical device is intended for use in an electromagnetic environment in which the disturbances due to RF radiation are controlled. The user or installer of the medical device can help prevent electromagnetic interference by maintaining a min- imum distance, according to the maximum output power of the radio-frequency transmission equipment.
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Technical description Electromagnetic immunity, portable radio-frequency equipment The medical device is intended for use in a magnetic and electromagnetic environment as described in the table below. The user and installer must ensure compliance of the electromagnetic environment. Electromagnetic environ- Immunity test Test level Compliance level ment/comments WARNING: 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 DEVICE UNDER TEST, including the cables specified by the manufacturer. Otherwise, the performance of this equipment may be impaired.
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Monnal T60 Comment: These specifications may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) The electromagnetic field strengths of fixed radio-frequency transmitters, such as base stations for mobile phones (cellular/wireless), mobile radios, amateur radio operators, AM/FM radio broadcasts and TV broadcasts cannot be determined accurately through theory. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be carried out. If the intensity level of the radio-frequency...
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Technical description NOTE 1: At 80 Mhz and 800 MHz, the highest frequency range is applicable. NOTE 2: These directives may not apply in all situations. Electromagnetic propagation is affected by absorption and by reflection from buildings, objects and persons. a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are from 6.765 MHz to 6.795 MHz; from 13.553 MHz to 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 MHz to 40.70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz to 2.5 GHz are intended to reduce the probability of interference that could be caused by mobile/portable communication devices that might accidentally be introduced into the patient areas.
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Monnal T60 9.4.3.5. Recommended separation distances between portable and mobile RF communication devices and the Monnal T60 (IEC 60601-1-2 3rd edition) The Monnal T60 ventilator is intended for use in an electromagnetic environment where RF radiated distur- bances are controlled. The user of the Monnal T60 ventilator can help to prevent electromagnetic interference by ensuring that portable and mobile RF communication devices (transmitters) are kept at least a certain dis- tance away from the Monnal T60 ventilator, as recommended below, according to the maximum output power...
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Technical description 9.4.3.6. Pneumatic specifications High-pressure (HP) and low-pressure (LP) O intakes NF, DISS, NIST (HP) Type of gas fitting Spiral fitting (LP) 2.8 - 6 bar / 280 - 600 kPa / 40 - 86 psi (HP) pneumatic supply 0 - 1.5 bar / 0 - 150 kPa / 0 - 22 psi (LP) Required maximum flow rate 105 L/min at 2.8 bars / 130 L/min at 6 bars (HP), (at atmospheric pressure)
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Monnal T60 Compatibility of accessories (parts of the respiration system which can be removed and assembled by the operator) Adult: max 5.5 cmH O @ 30 L/min Inspiratory resistance Child: max 5.5 cmH O @ 15 L/min Infant: max 5.5 cmH O @ 2,5 L/min Adult: max 6 cmH O @ 30 L/min Expiratory resistance...
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Monnal T60 9.4.3.8. Monitoring specifications Curves Adjustable on successive scales: -10 to +10, -20 to +20, Flow rate (L/min) -40 to +40, -80 to +80, -160 to +160, Adjustable on successive scales: 0 to +20, Pressure (cmH 0 to +40, 0 to +60,...
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Technical description 9.4.3.9. Measurement parameters Flow rate and volume measurement condition: BTPS Measure- Resolu- Measured parameters Precision Filtering ment tion Peak airway pressure 0 - 100 ± (2 cmH O + 4%) 15 ms (Ppeak, cmH Positive expiratory pressure 0 - 100 ± (2 cmH O + 4%) 15 ms (PEEP, cmH...
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Monnal T60 9.4.3.10. Oxygen sensor specifications Approximately 5000 h (variable time according to concentra- Lifespan tion and temperature) Conditions of storage and use Identical to those of the machine Supplied by the ventilator, including when operating on internal Power supply battery Calibration is performed automatically during the interactive tests.
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Technical description 9.4.3.11. Specifications of accessories IRMA™ probe For more information, please refer to the IRMA™ user manual from MASIMO. Patient circuit Adult single-use patient circuit with water trap Catalogue Number KG019300 Resistance at 60L/min 1.2 cmH Compliance 1.2 mL/cmH Volume 1050 cm Adult single-use patient Catalogue Number KG020100 Resistance at 60 L/min 0.4 cmH Compliance 1 ml/cmH Volume...
Monnal T60 9.4.4. Settings tables Settings adult child infant Name Mode Label Unit range range range reso- default reso- default reso- default lution value lution value lution value min. max. min. max. min. max. 4 be- 4 be- 4 be- Emer-...
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Technical description Settings adult child infant Name Mode Label Unit range range range reso- default reso- default reso- default lution value lution value lution value min. max. min. max. min. max. square deceler- ated SIMV PEEP PSIMV Expiratory pressure PRVC PS-Pro PSV / PEEP Duo-...
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Monnal T60 Settings adult child infant Name Mode Label Unit range range range reso- default reso- default reso- default lution value lution value lution value min. max. min. max. min. max. SIMV Trig.E PSIMV PS-Pro Expiratory trigger PSV / Trig.E...
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Technical description Settings adult child infant Name Mode Label Unit range range range reso- default reso- default reso- default lution value lution value lution value min. max. min. max. min. max. except Triggering VCV, Tapnea duration PS-Pro PRVC M: 175 Emer- F: 165 gency Height...
Technical description 9.4.6. Calculation of predicted body weight Predicted weight based on: Predicted body Height weight weight (kg) • Height <= 84 cm: WHO child growth standards Category • 84 cm < Height <=144 cm: Inch Female Male Adults and Pediatrics. Peck Formula. Tech. Report. 10. Div. Clin. Pharmacol. Uniformed Services University of the Health Sciences. Predicted weight (man) = 59.6035 + [5.2878 x height] - Infant [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] •...
Monnal T60 9.4.7. Interdependency of settings PCV Mode: Pressure Support Ventilation minimum of 5 cmH → PI - PEEP > 5 cmH PSV, PSV / NIV Modes: Maximum insufflation pressure of 60 cmH O → PSV + PEEP < 60 cmH VCV Mode: Minimum peak rate of 5 L/min. Maximum peak rate of 150 L/min. The form of the flow rate, the VT, and the parameters RR, I:E and Tplat are interdependent in order to comply with the conditions given above.
Technical description 9.4.9. Alarm thresholds – CPV Alarm threshold Name Label Range Resolution Default value Peak pressure Ppeak auto threshold: Pmeasured + max. (20%, 5) Low pressure Pmin OFF, 1 No auto threshold auto threshold: RR measured Low frequency - 50% (limited to 4 bpm) High frequency auto threshold: RR measured + 50% (limited to 90 bpm) Low exp.volume*...
Appendix 10. Appendix 10.1. Checklist When a device is commissioned and after any maintenance operation, carry out the sequence of actions below: Yes, No, done done - Connect the unit to the O 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.
All technicians trained by Air Liquide Medical Systems are given a copy of the maintenance manual. Use only authorized spare parts. Air Liquide Medical Systems is an activity of the Health- care Division of Air Liquide 5 years 6 years Date: ........
This section helps users to better identify and understand some of the issues that may occur when using the Monnal T60 ventilator. If the problem persists, do not attempt to open the device. Contact your technical service, Air Liquide Medical Systems or your Air Liquide Medical Systems distributor.
To see the specified limits for resistances, see 9.4.3.6. Humidity and nebulization can increase the resistance of the filters. 7. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
To see the specified limits for resistances, see 9.4.3.6 Humidity and nebulization can increase the resistance of the filters. 4. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
To see the specified limits for resistances, see 9.4.3.6 Humidity and nebulization can increase the resistance of the filters. 4. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
If the effort of the patient is too strong, because the patient needs a higher volume than the set Vt, it will lead to a “Patient disconnection!!!” alarm because the device doesn’t detect an inspiratory pressure increase. 7. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
• Problem with the contact of the expiratory flow sensor, on the Monnal T60 side. In this case, it is necessary to contact a qualified maintenance personnel. Troubleshooting steps 1. Check that the expiratory flow sensor is positioned correctly. 2. Run the autotests. 3. Check that the hot wire of the expiratory flow sensor is not damaged or deteriorated. Replace the expiratory flow sensor if necessary. In that case run the autotests. 4. Replace the expiratory flow sensor if the problem persists. Run the autotests. 5. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
4. Verify that there are no leaks around the O2 cell. 5. If the Monnal T60 contains an adhesive filter on the secondary air inlet, please check that it is not damaged. 6. Contact trained maintenance personnel in case of damage to replace it. 7. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
3. To troubleshoot, please use another power cord and power supply,to determine if that one is defective or the problem is related to the device itself. 4. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
5. If the values are consistent, this means that there is probably a leak, and that it is after the Y-piece. For ex- ample check the patient interface. 6. Repeat the previous steps after the replacement of the valve and the expiratory flow sensor. 7. If the problem persists contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor. YL180117 - Rev. 9D - 2020-03...
• Case 1 : The FiO2 measured by the Monnal T60 is the same as the value measured by the external oximeter. In that case, a calibration of the device will be necessary. Contact Air Liquide Medical Systems or your Air Liquide Medical Systems distributor.
10.3.12. Alarms N°089, 092 or 093: “O2 mixer defect!!! Ventilation Effective to 21%” Problem A failure of the O2 mixer which allows to deliver the FiO2, is detected and the Monnal T60 ventilates only with ambient air for safety purposes. These three alarms are related to a failure detected on three different components of the mixer.
• Avoid impacts or dropping it. Pre-disinfection / cleaning 1. Immerse the expiratory assembly components in a pre-disinfectant solution. Air Liquide Medical Systems recommends the use of products: neodisher MultiZym, Anios Clean Excel D (obey the instructions of the product manufacturer). 2. Rinse the parts under running water, except for the expiratory flow sensor (1), which should only be dipped in water.
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