MONNAL T60 User Manual sw ver V2.7.x Rev 9D March 2020

Monnal T60 4.9.11. 4.9.12. 4.9.13.

PRVC (Pressure-Regulated Volume Controlled)... 43 PS-Pro (Pressure Support - Pro)... 44 PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation)... 45

4.10. CPV: Cardio-Pulmonary Ventilation...46 4.11. Oxygen therapy...48 4.12. CO2 option...49 4.13. Keeping alarm settings and thresholds...50 4.14. Displaying the curves ...52 4.14.1. 4.14.2.

Adjustment of scales... 52 Freezing the curves... 52

4.15. Monitoring...53 4.15.1. 4.15.2. 4.15.3. 4.15.4. 4.15.5.

Adjustment of alarm thresholds... 54 Automatic thresholds... 55 Display of measurements... 56 Trends... 57 Monitoring screen... 58

4.16. Menu...60 4.16.1. 4.16.2. 4.16.3. 4.16.4. 4.16.5. 4.16.6. 4.16.7.

Description... 60 Menu structure... 61 Sensors... 62 Low-pressure O2 ... 63 Patient monitoring... 64 Data transfer... 64 Configuration of the ventilator... 65

4.17. Other functions...67 4.17.1. 4.17.2. 4.17.3. 4.17.4.

100% O2 ... 67 Screen lock key (Lock) ... 67 Day/Night key... 67 180° Key... 67

4.18. Personalizing the device...68 4.18.1. Default patient... 69 4.18.2. Gender /Height configuration... 69 4.18.3. VT/PBW coefficient... 69 4.18.4. SI Unit... 69 4.18.5. Key configuration on the home screen... 70 4.18.6. Selecting the height display unit... 70 4.18.7. Choice of communication protocol... 70 4.18.8. Display of the ventilation timer... 70 4.18.9. Mains disconnection alarm... 70 4.18.10. Saving the ventilation settings and alarm thresholds... 71 4.18.11. Set-point selection... 71 4.18.12. Display of the monitoring blocks... 71 4.18.13. Display modes in the ‘other modes’ window... 71

5.

Alarms and other messages...72

5.1. Display...72 5.2. Alarm Acknowledgement ...74 5.3. Alarm inhibition...74 5.4. Preventive alarm inhibition ...75 5.5. Reset...75 5.6. History...75

4

YL180117 - Rev. 9D - 2020-03

 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. O2 Cell...97

9.

Technical description...98

9.1. Operation...98 9.1.1. 9.1.2. 9.1.3. 9.1.4.

Pneumatic system... 98 Ventilation function... 99 Air/O2 mixture ... 99 CO2 monitoring...100

9.2. Electrical power sources...100 9.2.1. 9.2.2. 9.2.3. 9.2.4.

Managing the power supply...100 AC power supply ...101 Interchangeable battery and internal battery...101 Battery status indicator LED...102

9.3. Inputs and outputs...103 9.3.1. 9.3.2. 9.3.3.

Video output...103 USB Connections ...103 Connectivity to hospital networks...104

9.4. Performance and characteristics...106 9.4.1. 9.4.2. 9.4.3. 9.4.4. 9.4.5. 9.4.6. 9.4.7. 9.4.8. 9.4.9.

Regulatory requirements...106 Recovery of the components of the medical device...106 Technical Characteristics...107 Settings tables...122 Settings table (CPV)...126 Calculation of predicted body weight...127 Interdependency of settings...128 Alarm thresholds...129 Alarm thresholds – CPV...133

9.5. Bibliography...134

10. Appendix...135 10.1. Checklist...135 10.2. Maintenance data sheet...136 10.3. Troubleshooting...137 10.3.1. 10.3.2. 10.3.3.

Introduction...137 Autotests failure: “Circuit resistance could not be calculated...137 Alarm N°003: “Expiratory Branch may be obstructed!!!” / Alarm N°130: “Obstructed expiratory branch!!! Safety

YL180117 - Rev. 9D - 2020-03

5

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. External power supply failure...144 10.3.10. Difference between the set and the monitored volumes in non-invasive ventilation...145 10.3.11. Difference between the FiO2 set value and the FiO2 monitored value 1... Alarm N°097: “O2 mixer defect!!! Ventilation Effective to 21%”...146 10.3.12. Alarms N°089, 092 or 093: “O2 mixer defect!!! Ventilation Effective to 21%”...147

10.4. Expiratory assembly cleaning protocol...148 10.4.1. 10.4.2.

6

Monnal EVA autoclavable expiratory assembly...149 Monnal EVA single-use expiratory assembly...149

YL180117 - Rev. 9D - 2020-03

Before use

1. Before use 1.1.

Requisite knowledge

Definitions of user warnings Warning

Warns the user of the risks associated with the use or misuse of the device: - occurrence of a technical problem or device malfunction, - slight or serious injury to the patient. If the risk to the patient is very high, the warning will appear in bold lettering. Information Highlights a particular item of information.

1.2. Intended use Monnal T60 is a standalone ventilator using air (propelled by a blower) used to treat infants (3 kg and above), children, and adults. It is not intended for neonatal ventilation. It is used for patient ventilation to compensate for or mitigate respiratory failure. Contact with the patient is made via an adequate patient interface (e.g., mask or endotracheal tube), which allows air to flow from the ventilator into the lungs. It is for use by hospital personnel (doctors, nurses, etc.) and is used: • for pre-admission transportation,* • for transportation within a hospital, • for transportation between hospitals,* • for intra-hospital emergencies, • in post-operative recovery rooms, • in intensive care. *Land transportation and air ambulances. Medical electrical system Monnal T60 is part of the medical electrical system consisting of the following components: • a CO2 measurement probe (IRMA™) • a Monnal Clean’In (HEPA) filter • a humidifier • a nebulizer • an interchangeable battery • an external power supply • oxygen from a supply network, cylinder, or concentrator. Monnal T60 provides monitoring for the following respiratory gases: oxygen and carbon dioxide (using the optional IRMA probe).

Persons intending to operate this ventilator must be trained in its use. Only persons who have fully read and understood this manual are authorized to handle and use this ventilator. The present manual is intended to give all information necessary for the correct utilisation of this ventilator, but is in no way intended to replace the medical prescription that is essential for adjusting the apparatus according to patient needs.

1.3. Training There are two main types of training: • training in the use of the ventilator, • training in the routine maintenance of the ventilator. Training in the use of the ventilator Training in the use of the ventilator takes around thirty minutes. It is carried out during installation in the hospital department by Air Liquide Medical Systems staff or by an authorized Air Liquide Medical Systems distributor. This training includes: • validation of the intended use and description of the ventilator, • installation and commissioning, • comprehensive presentation of the operating functions of the ventilator, • practice on a test lung, adapted to the type of hospital service. This training can be repeated or covered in more depth at the request of the users, by contacting the usual Air Liquide Medical Systems representative. Training in routine maintenance Training in the routine maintenance of the ventilator takes around thirty minutes. It is carried out during delivery to the biomedical department, or during installation in the hospital department by Air Liquide Medical Systems staff or by an authorized Air Liquide Medical Systems distributor. It is intended for biomedical teams and equipment supervisors in the department. The training includes: • consumables management • daily recommended maintenance practices • monitoring minor alarms

YL180117 - Rev. 9D - 2020-03

7

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 cmH2O in pressure-controlled mode. It can also supply FiO2 from 21 to 100%. This is continuously monitored. It features the following ventilation modes and functions: VCV (controlled ventilation or assisted volume-controlled ventilation) PCV (controlled ventilation or assisted pressure-controlled ventilation) PSV (spontaneous ventilation with inspiratory assistance and PEEP) PSV / NIV (spontaneous ventilation with inspiratory assistance/non-invasive ventilation) CPAP (Continuous Positive Airway Pressure) SIMV (intermittent assisted controlled ventilation) PSIMV (intermittent assisted pressure-controlled ventilation) Duo-Levels (Alternation of two CPAP levels) NIV (Non Invasive Ventilation) PRVC (Pressure-regulated volume controlled ventilation) PS-Pro (Spontaneous ventilation with inspiratory assistance, PEEP and servomechanism frequency) Oxygen therapy CPV (Cardio-Pulmonary Ventilation) The device is equipped with an 8.4-inch colour touch screen, an ergonomic control wheel and a functional interface for adjustment of the various settings and ventilation parameters. Patient environment During normal use, the patient is lying on a hospital bed with the Monnal T60 device placed close by. All parts of the medical electrical system are suitable for use in the patient environment. User position The human machine interface of the device faces the user so that the user can make the necessary adjustments with the control wheel and read the information displayed on the screen. The recommended distance depends on the environment, the ambient lighting and the user’s visual acuity. The back of the device is accessible to the user.

8

YL180117 - Rev. 9D - 2020-03

Before use

1.5. Symbols and markings on the device

IP34

​

Weight and rated output of product

Expiratory valve eject button

Weight of Monnal T60 device

Weight of complete system (Monnal T60, mobile stand, articulated arm, 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

Class II

IRMA™ CO2 probe connector

Caution: refer to the user manual On the device, the symbol is shown in blue.

Lithium-ion interchangeable battery

Type BF applied part protects against defibrillation shocks.

Internal battery status indicator

ON button

Interchangeable battery status indicator

Protection Index according to the EN 60529 standard 3: protection from the penetration of solid bodies of diameter ≥ 2.5 mm 4: Protection from water splashing from any direction

USB connector

DC power supply connector

This logo means that the equipment must not be disposed of via ordinary waste channels. It must receive appropriate end-of-life handling, in accordance with European Directive 2012/19/ EU (WEEE). This device was manufactured after 13.08.05.

Do not let liquid enter this area.

Mains power supply or DC voltage

Direct current

VGA video output

Alternating current

Oxygen cell hatch open

Curtis Straus Bureau Veritas S-Mark

YL180117 - Rev. 9D - 2020-03

9

Monnal T60 Specific symbols for IRMA™ CO2 measurement probe

IP44

10

Protection Index according to the EN 60529 standard 4: protection from the penetration of solid bodies of diameter ≥ 1 mm. 4: protection from water splashing from any direction

Type BF device

YL180117 - Rev. 9D - 2020-03

Before use

1.6. General safety instructions Use of oxygen • Precautions in case of oxygen leak: • No smoking • Avoid any flame or source of sparks • Disconnect the oxygen source • Ventilate room during leakage and at least 20 minutes after leakage. • Air one‘s own clothing. • The device must not be in operation near any incandescent source. • This ventilator must not be used with inflammable anesthetic agents or explosive products. • Do not use the equipment with helium or helium mixed with another gas. • The ventilator does not directly administer nitric oxide but can be used concomitantly with a Nitric Oxide administration system, provided that the manufacturer of the nitric oxide delivery system has validated its use. • Do not use the device with components that have been contaminated by inflammable substances (e.g. grease, oil, etc.). • The internal components of the device were degreased before delivery or use a type of grease which is compatible with oxygen. Do not grease or lubricate any part of the device. • Medical grade oxygen must be used (i.e. dust-free and dry, H2O < 20 mg/m3). • The supply pressure must be between 280 kPa (2.8 bars) and 600 kPa (6 bars). • 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. • It is recommended to use adhesive electrodes. • During the defibrillation: • remove the oxygen mask or the nasal cannula and keep it at least 1 m from the patient’s torso; • if the patient is intubated, leave the ventilator connected; • ensure that the oxygen-enriched air at the outlet of the expiratory valve is not facing the patient’s torso. Electrical power supply • Check that the voltage in the mains socket used matches the electrical characteristics of the ventilator (indicated on the rear panel of the power supply adapter). • Use only the mains cable and mains power supply box supplied with the device. • If an external power supply is used, check that the voltage and current used match the electrical characteristics of the ventilator (indicated on the side of the ventilator). • The mains power supply adapter is not protected from splashes of water (IPX0), unlike the device itself, which complies with IPX4 during battery-powered operation. • This ventilator has an internal battery and an interchangeable battery. The device must be connected to the mains regularly to maintain the battery charge at a suitable level. • In the event of any doubt about the condition of the mains power supply cable, use the device on its internal battery only. • In case of long battery-powered operation, we recommend keeping a spare interchangeable battery on hand. • Do not use antistatic or electrically conductive pipes. • The user must not touch the patient and the equipment enclosures at the same time.

YL180117 - Rev. 9D - 2020-03

11

Monnal T60 Internal battery electrical power supply • The internal battery is a backup power source only. If connection to the mains power supply (primary power source) is impossible, an interchangeable battery (secondary power source) must be used. Using the internal battery as the main power source can cause ventilation to stop unexpectedly. IP Protection • To ensure the IP protection level of the device is maintained during normal use, it is essential that all removable components (air filter, expiratory assembly, O2 sensor cover and the rear plastic panel) are fitted in place Electromagnetic compatibility • The presence of equipment as diathermy units, high frequency electro-surgical equipment, defibrillators and cellular telephones or of electromagnetic interferences exceeding EN 60601-1-2 levels in its vicinity may interfere with the normal operation of the ventilator. • The Monnal T60 should not be placed next to or on top of this equipment. If such use is necessary, the Monnal T60 should be observed together with the other ventilators to ensure that they are operating normally. • Do not use this ventilator in a specifically magnetic environment (MRI, NMR, etc.). • Monnal T60 is compliant with the requirements defined in standard EN 60601-1-2 relating to the electromagnetic compatibility of medical devices. Precautionary measures are required with this device in terms of EMC and the devices must be installed and put into operation in accordance with the EMC information provided in this user manual. • 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 immunity of the device. Connection to other electrical devices • Do not connect the device to other electrical appliances not mentioned in this user manual without first consulting the manufacturers concerned or a specialist. • Devices connected to the inputs and signal outputs must comply with the 60601-1 Standard. Set-up • The device must not be put into service immediately after storage or transportation where the temperature and humidity were different from the recommended operating conditions. • Before each use, check that the audible and visual alarms are working correctly and carry out the checks listed in the appendix (see section ““10.1 Checklist”). • The ventilator should not be covered or positioned in such a way that its functioning or performance are affected. Always leave some space around the device: for example, never place the ventilator close to a curtain which could impede the fresh air flow and cause overheating. • If the Monnal T60 is installed on the universal support (KA010400), follow the instructions in the assembly manual. Ensure that the structure or unit (bed rail, for example) onto which the universal support is mounted can support the weight of the Monnal T60. Use • The manufacturer has tried to anticipate most of the possible malfunction scenarios of this ventilator, and these are normally monitored by the internal monitoring system. It is nevertheless recommended, in cases of complete patient dependence, that you provide an additional, fully autonomous system which can be used to check the effectiveness of the ventilation, as well as a back-up device, such as a suitable manual insufflator. • Lack of an alternative means of ventilation may result in patient death should the ventilator fail. • If the accessories used are not compliant with the manufacturer‘s recommendations, the manufacturer accepts no responsibility in the event of an incident. • Do not expose the device to direct sunlight. • Do not use Monnal T60 in a hyperbaric chamber. • 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;

12

YL180117 - Rev. 9D - 2020-03

Before use • between ventilator uses in the bag, leave a bacteriological filter or patient circuit on the inspiratory outlet of the ventilator; • during cleaning, leave a bacteriological filter or a patient circuit on the inspiratory outlet of the ventilator; • clean the inside of the bag regularly. Transportation • During transportation, we recommend that you use the device in its protective carry bag. The case must be securely fastened in the vehicle using the strap loops provided for the purpose. • 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. Risk of cross-contamination • Reusing single-use accessories or consumables carries the risk of patient cross-contamination. This risk also arises if reusable accessories or consumables are not sterilized between each use. • The breathing tube, mask, patient circuit, bacteriological filters, expiratory valve, humidification chamber, CO2 probe or nebulizer adapters are part of the air path and can be contaminated under normal operating conditions, and in the event of a single fault condition by bodily fluids, secretions or gas exhaled by the patient. Maintenance • This ventilator must be checked regularly. To plan and keep a record of all maintenance, operations, refer to the maintenance sheet in the appendix. • In accordance with the EN 60601-1 Standard (Appendix A, Para. 6.8.2.b), the manufacturer, the assembler, the installer or the importer shall only consider itself responsible for the effects on the safety, reliability and characteristics of a device if: • “Assembly, extensions, adjustments, modifications or repairs have been carried out by persons whom it has authorized; • The electrical installation in the corresponding area is compliant with IEC recommendations. • The device is used in conformity with the instructions for use.” • The approved technician must use only Air Liquide Medical Systems spare parts when carrying out routine maintenance of the device. • Do not use abrasive powders, alcohol, acetone or other easily flammable solvents. • The device must be disconnected from the mains during any procedure such as maintenance or cleaning. Recommendations for aspiration • Aspiration may be carried out according to different methods: fully unplugging the circuit, opening a respiratory circuit connection, or closed system. • When using a breathing tube in a closed system, it is advised to use the PAC mode with the parameters adjusted to the patient and, if tolerated, a PEEP of at least 3 cmH2O. Medical contraindications • Certain conditions require appropriate treatment before ventilator use. The absence of such treatment may have negative effects on the patient‘s health. • Monnal T60 is not suitable for very low-weight patients (premature infants, and infants under 3 kg). • Monnal T60 cannot be used in magnetic resonance imaging (MRI) rooms unless a sufficiently long circuit is added. • Monnal T60 is not designed for hyperbaric ventilation. • The CPV ventilation function (cardiopulmonary ventilation, optional) is not suitable for children and infants. Recommendations for using the MASIMO IRMA™ CO2 measurement probe See “4.12. CO2 option”, page 49.

YL180117 - Rev. 9D - 2020-03

13

Monnal T60

2. Description of the device 2.1. Terminology Used

1

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)

3

Interface between the user and the device • Permits adjustment of all ventilation settings. 3. Alarm indicators Illuminates to inform the user that an alarm has been activated. • Red fast flashing (2 Hz) = high priority • Yellow slow flashing (0.5 Hz) = medium priority • Steady yellow = low priority

4

2

4. Control wheel •

This is used to adjust and confirm the parameters.

5. AC power supply indicator light 6. Internal battery status indicator 7. Interchangeable battery status indicator

5

6

7

Handle Side 8. Secondary air inlet 9. Speaker Base Side 10. Electrical connection with the hot wire expiratory flow sensor (expiratory assembly withdrawn)

8

9

10

14

YL180117 - Rev. 9D - 2020-03

Description of the device

2.3. Right-hand side: Patient circuit connection panel 12

11

11. Cooling vent 12. IRMA™ CO2 probe connector socket 13. Inspiratory circuit connection 14. Expiratory valve eject button 15. Expiratory circuit connection 16. Hot wire expiratory flow sensor

2.4. Left-hand side: Turbine air inlet panel

16

17

17. ON/OFF button 18. Electrical power supply connector 19. Anti-pull cable protection clip 20. High-pressure oxygen inlet 21. Cooling vent 22. Interchangeable battery housing 23. Low-pressure oxygen inlet 24. Air inlet

18

15

14

13

19

20

21

24

23

22

2.5. Rear panel 25. FiO2 cell 26. Electrical connections for a wall-mounted charging station

25

26

YL180117 - Rev. 9D - 2020-03

15

Monnal T60

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. 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”).

Left-hand side: Location of power cable with Anti-pull cable protection clip

3.2. Connections and commissioning 3.2.1.

Electrical power supply

Connect the electrical power supply cable to the ventilator (see opposite), and then connect it to an AC power supply socket. Always check that the electrical network is compatible with the specifications in this manual. Check that the power cable is not damaged. Leave enough space behind the device for removing the cord from the power outlet when stopping the machine. The power cord enables Monnal T60 to be disconnected from the power supply on all poles simultaneously.

3.2.2.

Oxygen supply

To use a mixture with more than 21% oxygen, connect the ventilator’s high- or low-pressure O2 inlet to a valid source via an appropriate connector. If this oxygen source is a high pressure transport cylinder, it must be equipped with a pressure reducer to suit the allowable pressure range (2.8 to 6 bar). Start by connecting the O2 connection hose to the ventilator before connecting it to the oxygen network. Check the capacity of the oxygen cylinder before using the ventilator.

16

YL180117 - Rev. 9D - 2020-03

Installation and commissioning 3.2.3.

Assembly of patient circuit and accessories

Make sure that the use of accessories does not affect the safety and the expected performance of the device. Only use the accessories described below with the Monnal T60. Monnal T60 is compatible with double-branch, adult and pediatric circuits. Y-piece

Double-branch patient circuit

It is necessary to use a hydrophobic bacteriological filter (1) on the ventilator’s inspiratory outlet (2). 2

1

An HME (3) (heat and moisture exchanger) filter can be used in addition to the hydrophobic bacteriological filter (1). It must be placed on the Y-shaped part(4).

3

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. In a case where the expiratory valve is not fitted, assemble the expiratory valve as shown in “10.4 Expiratory assembly cleaning protocol” then insert it into the housing until you here it click into place. Double-branch patient circuit Connect the patient circuit to the ventilator and the humidifier (if used):

27

28

•

Connect the expiratory branch to the expiratory valve ofthe ventilator:

(27).

•

Connect the inspiratory branch to the inspiratory outlet cone of the ventilator:

(28).

Make sure to limit dead space when installing the patient circuit and accessories.

YL180117 - Rev. 9D - 2020-03

17

Monnal T60 When using the equipment on a patient for the first time, make sure that you follow the hospital’s hygiene protocol for new single-use equipment or adequately sterilized reusable equipment. The accessories and consumables (patient circuit, masks, expiratory valves, adapters, nebulizer, etc.) are generally available in single-use and autoclavable versions. Reusing single-use accessories or consumables carries the risk of patient cross-contamination. This risk also arises if reusable accessories or consumables are not sterilized between each use.

3.2.4.

CO2 Measurement Probe (IRMA™)

CO2 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, • the CO2 probe for measuring the concentration of exhaled carbon dioxide (in accordance with ISO 80601-255), • the necessary adapters. etCO2 connector

1. Connect the IRMA™ probe to the etCO2 connection socket (see opposite). 2. Apply power to the ventilator. 3. Connect the probe to its patient adapter (a). The probe is correctly connected to its adapter when you hear it click into position. 4. Wait at least 10 seconds. If the etCO2 monitoring block does not show 0%, or if the error ‘CO2 measurement incorrect’ is displayed, a calibration test should be carried out. See “4.16.3. Sensors”, page 62. 5. The LED flashes and then goes green. This means that the IRMA™ probe is ready for use (b). Pre-use checks (for each new patient)

18

YL180117 - Rev. 9D - 2020-03

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 etCO2 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™ probe to the patient’s endotracheal tube (d). 5. Position the IRMA™ probe (e) (see photo opposite). The probe sends information and alarms to the Monnal T60. The probe has an LED indicating the following statuses: LED status

Description

Continuous green Flashing green Continuous red Flashing red

OK Calibration in progress Probe error Checking the adapter

3.2.5.

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 humidifier. Remember to empty the water traps regularly during ventilation. Ensure that water does not enter the unit during handling of the patient circuit or the humidifier (if used). If this occurs, immediately stop using the device, and contact the Technical Department. Humidification may increase the resistance of the filters used in the patient circuit. The filters should be tested frequently to check for an increase in resistance or blockage.

3.2.6.

Nebulizer

Y-piece respiratory filters can prevent medication from being effective: their use is therefore not recommended, end.

The precision of the expired volume can be impaired: a protective filter can then be used at the expiration

Nebulization may increase the resistance of the filters used in the patient circuit. The filters should be tested frequently to check for an increase in resistance or blockage.

3.2.7.

Interchangeable battery

Prior to using the interchangeable battery for the first time, please complete the blank expiration date label supplied with the battery (2 years after date of first use).

YL180117 - Rev. 9D - 2020-03

19

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). ON/OFF button

The initialization tests start up (duration: up to 5 s). The buzzers sound and the alarm indicators light up. After the initialization tests, the machine displays the start-up screen. When switching the device on using internal/external battery (no mains supply connected), the ON/OFF button may need to be pressed for an extended period of time than normal to start the device (approximately 3 seconds). Make sure that you have fully charged both batteries (internal and interchangeable) before using the ventilator.

20

YL180117 - Rev. 9D - 2020-03

Installation and commissioning 3.2.9.

Automatic tests

The automatic tests check the integrity and correct operation of the unit’s internal components. 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. Air Liquide Medical Systems therefore recommends the running of these automatic tests before each use on a patient. 1. To launch the automatic tests, press the Automatic tests key. 2. Follow the instructions on the screen. 3. Press Validate to confirm the launching of tests. At the end of testing, a window is displayed with the instruction to remove the plug from the Y-piece on the patient circuit, accompanied by an audible reminder every 2 minutes. If the user does not disconnect the patient circuit, the test stops after 20 minutes. Press “Restart “to resume the last stage of the autotests. The automatic tests end a few seconds after the cap is taken off the Y-piece. When the tests are over, press End. To interrupt the tests, press Stop and then Finish. To resume the tests, press Restart and then Validate. If the autotests fail with the message “Circuit resistance not evaluated”: • check that the selected patient category matches the patient circuit used, • check that the patient circuit is correctly connected to the device, • check that the filters and other accessories used do not generate too high a resistance. Make sure that the patient category selected corresponds to the patient circuit and the accessories used (see section “4.5.1 Selecting the patient category”).

YL180117 - Rev. 9D - 2020-03

21

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 standby’. The start-up screen is used to: • Select the ventilation mode, • Start ventilation, • Choose the patient category, • Start the automatic tests, • Shut down the unit. It also displays: • The current software version, • Ventilation time counter, • The power-on time counter, • The time and date.

22

YL180117 - Rev. 9D - 2020-03