User Manual
138 Pages
Preview
Page 1
User manual Software version V2.5.x
www.device.airliquidehealthcare.com
EN
YL180117 - Rev 7 - 2018-01
MONNAL T60
Contents I. Before use...6 I.1. I.2. I.3. I.4. I.5.
Definitions of user warnings... 6 Intended use ... 6 Brief description of the device... 7 Symbols and markings on the device... 8 General safety instructions... 10
II. Description of the device... 13 II.1. II.2. II.3. II.4. II.5.
Terminology Used... 13 Front view... 13 Right-hand side: Patient circuit connection panel... 14 Left-hand side: Turbine air inlet panel... 14 Rear panel... 14
III. Installation and commissioning ... 15 III.1. III.2.
Unpacking... 15 Connections and commissioning... 15
III.2.1. III.2.2. III.2.3. III.2.4. III.2.5. III.2.6. III.2.7. III.2.8. III.2.9.
Electrical power supply ...15 Oxygen supply...15 Assembly of patient circuit and accessories... 16 CO2 Measurement Probe (IRMA™)...17 Humidifier... 18 Nebulizer... 18 Auxiliary battery... 18 Applying power... 19 Automatic tests ...20
IV. Use... 21 IV.1. IV.2. IV.3. IV.4. IV.5.
Start-up screen...21 Ventilation screen...24 Home screen (current ventilation)...25 Ventilator controls...26 New patient...28
IV.5.1. IV.5.2.
Selecting the patient category...28 Selecting the patient height and gender...29
IV.6. IV.7. IV.8. IV.9.
Emergency ventilation start-up... 30 Start / stop ventilation... 31 Shutting down the unit...32 Ventilation modes...33
IV.9.1. IV.9.2. IV.9.3. IV.9.4. IV.9.5. IV.9.6. IV.9.7. IV.9.8. IV.9.9. IV.9.10.
Mode selection...33 Ventilation settings...33 Apnea ventilation adjustment...34 VCV (controlled ventilation or assisted volume-controlled ventilation)... 35 PCV (controlled ventilation or assisted pressure-controlled ventilation)...36 PSV (spontaneous ventilation with inspiratory assistance and PEEP) ...37 SIMV...38 PSV / NIV (non-invasive ventilation)...39 CPAP (Continuous Positive Airway Pressure)...40 Duo-Levels (Alternation of two CPAP levels)...41
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Monnal T60 IV.9.11. IV.9.12. IV.9.13.
PRVC (Pressure-Regulated Volume Controlled)...42 PS - PRO (= Pressure Support - Pro)...43 PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation)...44
IV.10. IV.11. IV.12. IV.13.
CPV: Cardio-Pulmonary Ventilation... 45 Oxygen therapy...47 Keeping alarm settings and thresholds... 48 Displaying the curves ... 50
IV.13.1. IV.13.2.
Adjustment of scales...50 Freezing the curves...50
IV.14. Monitoring...51 IV.14.1. IV.14.2. IV.14.3. IV.14.4. IV.14.5.
Adjustment of alarm thresholds... 52 Automatic thresholds... 53 Display of measurements... 54 Trends... 55 Monitoring screen...56
IV.15. Menu... 58 IV.15.1. IV.15.2. IV.15.3. IV.15.4. IV.15.5. IV.15.6. IV.15.7.
Description...58 Organisation... 59 Sensors...60 Low-pressure O2 ... 61 Patient monitoring... 62 Data transfer... 62 Configuration of the ventilator...63
IV.16. Other functions...65 IV.16.1. IV.16.2. IV.16.3. IV.16.4.
IV.17. IV.17.1. IV.17.2. IV.17.3. IV.17.4. IV.17.5. IV.17.6. IV.17.7. IV.17.8. IV.17.9. IV.17.10.
100% O2 ...65 Screen lock key (Lock) ...65 Day/Night key...65 180° Key...65
Personalising the device... 66 Default patient... 67 Gender /Height configuration... 67 VT/PBW coefficient... 67 SI Unit... 67 Key configuration on the home screen...68 Selecting the height display unit...68 Saving the ventilation settings and alarm thresholds...69 Set-point selection...69 Display of measurement blocks...69 Display modes in the ‘other modes’ window...69
V. Alarms and other messages... 70 V.1. V.2. V.3. V.4. V.5. V.6. V.7.
Display...70 Alarm Acknowledgement ...72 Alarm inhibition...72 Preventive alarm inhibition ...73 Reset...73 History...73 Table of alarms...74
VI. Maintenance... 87 VI.1.
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Definitions...87
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VI.2. VI.3. VI.4. VI.5.
Routine Maintenance...87 Bacteriological filter... 88 Air inlet filter (Monnal Clean’In) ... 88 Expiratory assembly: Flow sensor + expiratory valve... 89
VII. Accessories... 91 VII.1. Regulatory requirements... 91 VII.2. Items included in the package...92 VII.3. List of options and accessories ...93
VIII. Maintenance... 96 VIII.1. By the user... 96 VIII.2. By the technician... 96 VIII.3. O2 Cell...97
IX. Technical description... 98 IX.1.
Operation... 98
IX.1.1. IX.1.2. IX.1.3. IX.1.4.
Pneumatic system...98 Ventilation function...99 Air/O2 mixture ...99 CO2 monitoring... 100
IX.2.
Electrical power sources... 100
IX.2.1. IX.2.2. IX.2.3. IX.2.4.
Managing the power supply... 100 AC power supply ...101 Auxiliary battery and internal battery...101 Battery status indicator LED...103
IX.3.
Inputs and outputs... 104
IX.3.1. IX.3.2. IX.3.3.
Video output...104 USB Connections ...104 Connectivity to hospital networks...105
IX.4.
Performance and characteristics... 106
IX.4.1. IX.4.2. IX.4.3. IX.4.4. IX.4.5. IX.4.6. IX.4.7. IX.4.8. IX.4.9.
Regulatory requirements...106 Recovery of the components of the medical device...106 Technical Characteristics... 107 Settings tables...120 Settings table (CPV)... 124 Calculation of predicted body weight... 125 Interdependency of settings...126 Alarm thresholds... 127 Alarm thresholds – CPV... 131
X. Bibliography...132 XI. Appendix...133 XI.1. XI.2.
Checklist...133 Expiratory assembly cleaning protocol...134
XI.2.1. XI.2.2.
Monnal EVA autoclavable expiratory assembly... 135 Monnal EVA single-use expiratory assembly... 135
XI.3.
Maintenance data sheet...136
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Monnal T60
I. Before use
Requisite knowledge
I.1.
Persons intending to operate this ventilator must be trained in its use.
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
Only persons who have fully read and understood this manual are authorised 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. Training There are two main types of training: • training in the use of the ventilator, • training in the routine maintenance of the ventilator.
Highlights a particular item of information.
Training in the use of the ventilator
I.2.
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.
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 auxiliary battery • an external power supply • oxygen from a supply network, cylinder, or concentrator.
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
Monnal T60 provides monitoring for the following respiratory gases: oxygen and carbon dioxide (using the optional IRMA probe).
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Before use
I.3.
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) PRCV (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.
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Monnal T60
I.4.
Symbols and markings on the device
IP34
8
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, auxiliary battery and patient cir²cuit)
Manufacturer
High pressure oxygen inlet fitting
Complies with European Directive 93/42/CEE Notified Body No. 0459.
Low pressure oxygen inlet fitting
Device Catalogue Number
Patient circuit inspiratory fitting
Serial Number of the device
Patient circuit expiratory fitting
Date of manufacture: YYYY-MM
IRMA™ CO2 probe connector
Class II
Lithium-ion auxiliary battery
Caution: refer to the user manual
Internal battery status indicator
Type BF applied part protects against defibrillation shocks.
Auxiliary battery status indicator
ON button
USB connector
Protection Index according to the EN 60529 standard
4: Protection from water splashing from any direction
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.
DC power supply connector
Mains power supply or DC voltage
Do not let liquid enter this area.
VGA video output
Direct current
Curtis Straus Bureau Veritas S-Mark
Alternating current
Oxygen cell hatch open
3: protection from the penetration of solid bodies of diameter ≥ 2.5 mm
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Before use Specific symbols for IRMA™ CO2 measurement probe
Protection Index according to the EN 60529 standard
IP44
4: protection from the penetration of solid bodies of diameter ≥ 1 mm.
Type BF device
4: protection from water splashing from any direction
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Monnal T60
I.5.
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 anaesthetic agents or explosive products. • Do not use the equipment with helium or helium mixed with another gas. • 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 adaptor). • 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).
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• The mains power supply adaptor 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 auxiliary 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 auxiliary 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. 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 it is not possible to do otherwise, the Monnal T60 should be monitored to make sure that it operates correctly where placed. • 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 CEM and the devices must be installed and put into operation in accordance with the CEM 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.
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Before use Set-up
Transportation
• 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 ““XI.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
• 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 137181, EN 1789 and EN 794-3 standards. Risk of cross-contamination
• 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 nicotineladen atmosphere (cigarette smoke, fire, etc.). • In order to prevent dust from entering: -- between ventilator uses in the bag, close the inspiratory limb cap; -- 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.
• 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 authorised; • 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.
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Monnal T60 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 • There are no specific contraindications for this ventilator. However, certain conditions require appropriate treatment before ventilator use. The absence of such treatment may have negative effects on the patient‘s health. Recommendations for using the MASIMO IRMA™ CO2 measurement probe • The IRMA™ probe may only be used by qualified, authorized medical personnel. • The mainstream IRMA™ multi-gas probe is intended to be connected to a patient circuit to monitor the gases inhaled/exhaled by adult or paediatric patients in emergency or intensive care situations. • The probe must not be the sole patient monitoring device. It must always be used with other devices to monitor vital signs and/or in addition to medical advice given by a qualified person. • The probe must not be in direct contact with the patient. • The IRMA™ probe must not be used with flammable anaesthetic agents. • IRMA™ adapters are a single-use product and must not be re-used for different patients. Used adapters must be disposed of via the appropriate hospital waste disposal channels. Reusing single-use adapters can lead to patient cross-contamination. • Do not use adapters for adult patients or children on infants, as this carries the risk of adding dead space. • Do not use adapters for infants on adult patients or children, as this carries the risk of increasing resistance. • The IRMA™ probe can give poor-quality measurements in the presence of devices that emit electromagnetic interference exceeding the levels mentioned in 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.
• When using the IRMA™ probe, place the adapter so that its XTP™ windows are vertical, to avoid an accumulation of patient secretions on these windows:
• When using the IRMA™ probe, position the adapter so that moisture and secretions do not accumulate inside it due to the effect of gravity. • Replace the adapter if humidity is observed on the inside. • Do not use the IRMA™ airway adapter with nebulized medications as this may affect the light transmission of the airway adapter windows. • If the calibration is not done properly, the measurement values will be skewed. • Never sterilise the IRMA™ probe or immerse it in liquid. • Do not pull on the cable of the IRMA™ probe. • Do not use the IRMA™ probe at a temperature below 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. • The probe can be cleaned using a cloth dipped in alcohol (maximum 70% ethanol or 70% isopropanol). • Remove the adapter before cleaning the probe. • The adapters are not autoclavable. • The gas measurements supplied by the probe must be checked regularly using a reference instrument. We recommend that this check be performed annually.
Use only IRMA™ probes sold by Air Liquide Medical Systems: Cat. No. KB020400 • Do not connect the IRMA™ at the outlet of an elbow connector, in order to avoid an accumulation of patient secretions in the adapter and the obstruction of XTP™ windows.
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Description of the device
II. Description of the device II.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.
II.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
2
4
4. Control wheel • This is used to adjust and confirm the parameters. 5. AC power supply indicator light 6. Internal battery status indicator 7. Auxiliary battery status indicator 5
Handle Side
6
7
8. Secondary air inlet 9. Speaker Base Side 10. Electrical connection with the hot wire expiratory flow sensor (expiratory assembly withdrawn) 8
9
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Monnal T60
II.3. Right-hand side: Patient circuit connection panel 11
11. Cooling vent
12
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
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17
II.4. Left-hand side: Turbine air inlet panel
18
15
14
13
19
20
21
24
23
22
17. ON/OFF button 18. Electrical power supply connector 19. Anti-pull cable protection clip 20. High-pressure oxygen inlet 21. Cooling vent 22. Auxiliary battery housing 23. Low-pressure oxygen inlet 24. Air inlet
II.5.
Rear panel
25. FiO2 cell 26. Electrical connections for a wall-mounted charging station
25
26
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Installation and commissioning
III. Installation and commissioning III.1.
Unpacking
Remove the ventilator from the packaging and place it horizontally on a table. Unwrap the accessories supplied with the ventilator.
Left-hand side: 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 “VI Maintenance”).
III.2. Connections and commissioning III.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.
III.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.
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Monnal T60 III.2.3. sories
Assembly of patient circuit and acces-
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.
Y-piece
Monnal T60 is compatible with double-branch, adult and paediatric circuits. Air Liquide Medical Systems recommends using the patient circuits listed in Chapter “VII.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.
Double-branch patient circuit
In a case where the expiratory valve is not fitted, assemble the expiratory valve as shown in “XI.2 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): •
onnect the expiratory branch to the expiratory C valve ofthe ventilator: (27).
•
onnect the inspiratory branch to the inspiratory C outlet cone of the ventilator: (28).
Take care to limit dead space whilst installing the patient circuit and accessories. 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. Air Liquide Medical Systems recommends the use of a bacteriological filter at the inspiratory outlet of the ventilator or, preferably, at the Y piece. It is also recommended that you use patient circuits equipped with water traps when using a humidifier.
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27
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Installation and commissioning III.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
etCO2 connector
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 80601-2-55), • the necessary adapters. 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 “IV.15.3. Sensors”, page 60. 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) 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
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Monnal T60 III.2.5.
Humidifier
If this ventilator is used with a humidifier, ensure that it is always placed lower than the ventilator and the patient. 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.
III.2.6.
Nebulizer
Y-piece respiratory filters can prevent medication from being effective: their use is therefore not recommended, The precision of the expired volume can be impaired: a protective filter can then be used at the expiration end. 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.
III.2.7.
Auxiliary battery
Prior to using the auxiliary battery for the first time, please complete the blank expiration date label supplied with the battery (i.e. 3 years after date of first use).
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Installation and commissioning III.2.8.
Applying power
Do not obstruct the vents located on the leftand 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 initialisation tests start up (duration: up to 5 s). The buzzers sound and the alarm indicators light up. After the initialisation 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 auxiliary) before using the ventilator.
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Monnal T60 III.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 “IV.5.1 Selecting the patient category”).
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Use
IV. Use This ventilator is controlled mainly via the touch screen and the control wheel. Avoid using any object that might scratch the screen.
IV.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.
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