Air Liquide MONNAL T75 User manual

| MONNAL T75
User Manual
English
Software version V3.6.x
www.device.airliquidehealthcare.com
YL072800 - Revision 9A - 2021-06 - EN
YL072800
V3.6.xI9A

Contents
Before use...............................................................................................7
Definitions of user warnings..............................................................................................................7
Intended use...................................................................................................................................... 7
Brief description of the device.......................................................................................................... 7
Requisite knowledge..........................................................................................................................8
Training..................................................................................................................................................8
Symbols and markings on the device............................................................................................. 10
General safety instructions..............................................................................................................11
Description of the device.......................................................................15
Terminology used............................................................................................................................ 15
Front panel....................................................................................................................................... 15
Right-hand side................................................................................................................................ 16
Left-hand side.................................................................................................................................. 16
Rear panel........................................................................................................................................ 17
Installation and commissioning.............................................................19
Unpacking.........................................................................................................................................19
Connections and commissioning.................................................................................................... 19
Power supply...................................................................................................................................... 19
Oxygen supply.................................................................................................................................... 19
Assembly of patient circuit and accessories.................................................................................. 19
CO2 Measurement Probe.................................................................................................................. 20
Humidifier............................................................................................................................................20
Nebulization........................................................................................................................................ 21
Applying power...................................................................................................................................22
Automatic tests.................................................................................................................................. 22
Transport on the rolling stand.......................................................................................................... 23
Use........................................................................................................ 26
Screen description........................................................................................................................... 27
Stand-by mode................................................................................................................................... 27
Ventilation mode................................................................................................................................ 28
Start/stop ventilation....................................................................................................................... 28
Shutting down the unit.................................................................................................................... 29
New patient / Category selection.................................................................................................... 29
Ventilator configuration................................................................................................................... 30
Language.............................................................................................................................................30
Date and time.....................................................................................................................................30
Transfer............................................................................................................................................... 31
Brightness........................................................................................................................................... 31
Audible alarm......................................................................................................................................31

Ventilation modes............................................................................................................................ 32
Mode selection...................................................................................................................................32
Ventilation set-points......................................................................................................................... 32
Description of ventilation modes.....................................................................................................33
VCV (Volume-Controlled Ventilation)................................................................................................33
PCV (Pressure-Controlled Ventilation)..............................................................................................33
PCV (Pressure-Controlled Ventilation)..............................................................................................34
SIMV (Synchronized Intermittent Mandatory Ventilation)...............................................................35
PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation).......................... 36
PSV NIV (Non Invasive ventilation).................................................................................................. 37
CPAP (Continuous Positive Airway Pressure)................................................................................. 38
Duo levels (Alternation of two CPAP levels)....................................................................................38
APRV (Airway Presure Release Ventilation).....................................................................................39
PRVC (Pressure-Regulated Volume Controlled).............................................................................. 39
PS – PRO (interlocked barometric mode, intended for use in resuscitation)................................40
Oxygen therapy................................................................................................................................ 41
CO2 Option.......................................................................................................................................43
Introduction.........................................................................................................................................43
Installing the CO2 software option...................................................................................................43
Display of pressure and flow rate curves........................................................................................ 43
Setting up the CO2 measurement probe......................................................................................... 44
Adjusting the CO2 unit...................................................................................................................... 45
Monitored CO2 parameters...............................................................................................................45
Activation or deactivation of CO2 monitoring................................................................................. 47
Calibrating the CO2 probe.................................................................................................................48
Recommendations for the use of the MASIMO IRMA™ CO2 measurement probe....................... 48
Display of pressure and flow rate curves........................................................................................49
Monitoring........................................................................................................................................ 51
Display of measurements..................................................................................................................51
Alarm settings.................................................................................................................................... 54
Automatic thresholds.........................................................................................................................56
Resetting............................................................................................................................................. 56
Alarm history...................................................................................................................................... 56
Measurements.......................................................................................58
Expiratory plateau............................................................................................................................ 58
Inspiratory plateau........................................................................................................................... 58
[R&C stat] key.................................................................................................................................. 58
P0.1 measurement key.................................................................................................................... 60
NIF (negative inspiratory force).......................................................................................................60
Manual Cycle....................................................................................................................................61
Work of Breathing (WOB)................................................................................................................ 62
Menu..................................................................................................... 63
Description....................................................................................................................................... 63
Menu structure.................................................................................................................................64
Apnea ventilation adjustment........................................................................................................... 64
TC (Tube Compensation).................................................................................................................. 65

O2 low pressure................................................................................................................................. 66
Sensors............................................................................................................................................... 67
Other functions................................................................................................................................ 67
Oxygenation function-suction............................................................................................................68
Screen lock key (lock)....................................................................................................................... 69
Inhibiting the spirometry sensor.......................................................................................................69
Nebulization........................................................................................................................................ 70
Loop curves........................................................................................................................................ 72
Trends..................................................................................................................................................73
Administrator configuration...................................................................75
Access..............................................................................................................................................75
Presentation..................................................................................................................................... 75
Setting inspiratory time in VCV mode (60)......................................................................................76
Setting inspiratory time in PCV mode (61)......................................................................................76
Inspiratory time monitoring (62)......................................................................................................76
Monitoring etCO2 (63)..................................................................................................................... 76
Disabling the RRmini set-point (64).................................................................................................76
Altered O2 network (65).................................................................................................................. 76
Volume setting (66)......................................................................................................................... 77
Enabling Options (67)...................................................................................................................... 77
Saving the ventilation set-points (68)............................................................................................. 77
Pressure Support Setting (69).........................................................................................................78
Setting the ventilation set-points (70).............................................................................................78
Selecting ventilation modes (71).....................................................................................................78
Alarms...................................................................................................80
Parameters.......................................................................................................................................80
Acknowledgement of alarms...........................................................................................................81
Inhibition of alarms..........................................................................................................................81
List of alarms...................................................................................................................................81
Maintenance..........................................................................................92
Definitions........................................................................................................................................ 92
Routine maintenance....................................................................................................................... 92
Expiratory assembly: flow sensor + expiratory valve Monnal EVA.................................................. 93
Monnal Clean’in filter (Type filtre HEPA: High- Efficiency Particulate Air)...................................... 94
Air intake filter................................................................................................................................. 95
Bacteriological filter.........................................................................................................................95
Accessories...........................................................................................96
Items included in the package........................................................................................................ 96
List of consumables........................................................................................................................ 96
List of accessories.......................................................................................................................... 97
List of available documents............................................................................................................ 98
Maintenance..........................................................................................99

By the user.......................................................................................................................................99
Battery life check............................................................................................................................... 99
By the technician........................................................................................................................... 100
O2 cell............................................................................................................................................ 100
Technical description.......................................................................... 102
Operation........................................................................................................................................102
Pneumatic system........................................................................................................................... 102
Ventilation operation........................................................................................................................103
Air/O2 mixture..................................................................................................................................104
Special characteristics of nebulization.......................................................................................... 105
CO2 monitoring................................................................................................................................ 105
Electrical power sources................................................................................................................105
Power supply management............................................................................................................ 106
Mains supply.................................................................................................................................... 106
Internal battery................................................................................................................................. 106
External battery................................................................................................................................ 107
Inputs and outputs.........................................................................................................................107
Alarm transfer...................................................................................................................................107
RS232 link.........................................................................................................................................108
Connectivity to hospital networks.................................................................................................. 108
Video output..................................................................................................................................... 110
Performances and characteristics.................................................................................................110
Regulatory requirements................................................................................................................. 110
Recovery of the components of the medical device.....................................................................110
Technical characteristics.................................................................................................................111
Settings tables..................................................................................................................................126
Testing the alarms.........................................................................................................................133
Bibliography........................................................................................ 134
Appendix............................................................................................. 135
Checklist.........................................................................................................................................135
Expiratory assembly cleaning protocol..........................................................................................136

1 Before use
1 Before use
1.1 Definitions of user warnings
CAUTION: 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.
Note: Highlights a particular item of information.
1.2 Intended use
Monnal T75 is a standalone turbine ventilator used to treat infants (weighing at least 3 kg), children
and adults. 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 al-
lows air to flow from the ventilator into the lungs.
It is for use by hospital personnel (doctors, nurses, etc.):
• In the intensive care unit,
• In the post-operative recovery room,
• When transporting patients in the hospital area.
Medical electrical system
Monnal T75 is part of the medical electrical system along with the CO2 measuring probe (IRMA™) (Ref.
KB033600).
It can also be operated with various accessories, such as:
• a Monnal Clean’in HEPA filter,
• a nebulizer,
• a humidifier,
• oxygen from a supply network, cylinder, or concentrator,
• an alarm transfer system.
Monnal T75 is used to monitor two respiratory gases – oxygen (O2) and carbon dioxide (CO2) (applies
to product reference KB033600).
1.3 Brief description of the device
Monnal T75 can supply tidal volumes from 20 to 2000 mL in volume-controlled mode, and insufflation
pressures from 0 to 99 cmH2O in pressure-controlled mode.
It can also supply FiO2 adjustable from 21 to 100% under continuous monitoring.
It has the following ventilation modes:
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Monnal T75 user manual
VCV (controlled ventilation or assisted volume-controlled ventilation)
PCV (controlled ventilation or assisted pressure-controlled ventilation)
PSV (spontaneous ventilation with inspiratory assistance and PEEP)
SIMV (intermittent assisted controlled ventilation)
PSIMV (intermittent assisted pressure-controlled ventilation)
PSV NIV (non-invasive ventilation).
CPAP (continuous positive airway pressure)
Duo Levels (alternation between two levels of CPAP).
PRVC (Pressure-regulated volume controlled ventilation)
PS-Pro: interlocked barometric mode, intended for use in resuscitation
APRV: Airway Pressure Release Ventilation
The device is equipped with a 10.4-inch color touch screen, an ergonomic control wheel and a func-
tional interface for easy adjustment of the various settings and ventilation parameters.
The ventilator may be used with a mobile stand, making it more convenient to move around, and can
be placed on a wall tablet.
CAUTION: The user is responsible for ensuring that the use of accessories does not affect
the safety and the expected performance of the device.
Patient environment
Under normal use, the patient is in a hospital bed and the Monnal T75 equipment is placed nearby. All
parts of the medical electrical system are suitable for use in the patient environment.
User’s position
The equipment is positioned with the display facing towards the user allowing them to make the nec-
essary adjustments with the coder wheel and read the information displayed on the screen. The rec-
ommended distance depends on the environment, the ambient light and the user’s visual acuity. The
rear of the equipment remains, however, within the user’s reach.
Options
Monnal T75– reference KB033600 - comes with the option of purchasing CO2 monitoring.
1.4 Requisite knowledge
Persons intending to operate this ventilator must be trained in its use.
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 ad-
justing the apparatus according to patient needs.
1.4.1 Training
There are two main types of training:
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1 Before use
• 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 dur-
ing delivery to the biomedical department, or during installation in the hospital department by Air Liq-
uide 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
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Monnal T75 user manual
1.5 Symbols and markings on the device
Weight and rated output of prod-
uct
ON button
Weight of Monnal T75 device Weight of the system (Monnal T75,
mobile stand, articulated arm, sock-
et base, external battery pack and pa-
tient circuit)
Manufacturer
O2
280 - 600 kPa
105 - 130 L / min
High pressure oxygen inlet fitting
Do not push
O2
0 - 150 kPa
0 - 85 L / min
Low pressure oxygen inlet fitting
Complies with European Direc-
tive 93/42/CEE Notified Body No.
0459.
Patient circuit inspiratory fitting
Device catalog number Patient circuit expiratory fitting
Serial Number of the device IRMA™ CO2 probe connector
Date of manufacture:
YYYY-MM
Nebulizer fitting
Caution: refer to the user manual. O2 cell cover locked
Protective earth (ground) O2 cell cover unlocked
Type B applied part Expiratory valve eject button
Alternating current Video output VGA
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1 Before use
IP3X
(if serial num-
ber below
MT75-05000)
IP31
(for serial
numbers from
MT75-05000)
Protection Index according to the
EN 60529 standard
3: protection from the penetration
of solid bodies of diameter ≥ 2.5
mm.
1: protection against vertically
falling water drops
X: no particular protection from
the penetration of liquids, but
compliant with EN 60601-1.
This logo means that the equipment
must not be disposed of via ordinary
waste channels. It must receive ap-
propriate end-of-life handling, in ac-
cordance with European Directive
2012/19/UE (WEEE).
This device was manufactured after
the 13th of August 2005.
Electrical protection fuse
COM 1
COM 2
RS232 connectors
Alarm transfer outlet External power supply connector
AC power supply indicator light
Specific symbols for IRMA™ CO2 measurement probe (ref. KB033600)
IP44 Protection Index according to the
EN 60529 standard
4: protection from the penetration
of solid bodies of diameter ≥ 1
mm.
4: protection from water splash-
ing from any direction
Type BF device
1.6 General safety instructions
Oxygen use
Precautions in case of oxygen leak:
• No smoking
• Avoid any flame or source of sparks
• Disconnect the oxygen source
• Fully air the room throughout the duration of the leak and for at least 20 minutes afterwards.
• Air one’s own clothing.
• The device must not be in operation near any incandescent source.
The device must not be used with inflammable anaesthetic agents or explosive products.
Do not use the equipment with helium or helium mixed with another gas.
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Monnal T75 user manual
The ventilator does not directly administer nitric oxide but can be used concomitantly with a Nitric Ox-
ide administration system, provided that the manufacturer of the nitric oxide delivery system has vali-
dated its use.
Do not use the device with components contaminated by inflammable substances (e.g. grease, oil,
etc.).
The internal components of the device were degreased before delivery and use a type of grease which
is compatible with oxygen. Do not grease or lubricate any part of the device.
Medical quality oxygen, which is dust-free and dry, must be used (H2O < 20 mg/m3).
The supply pressure on the high pressure oxygen inlet must be between 280 kPa (2.8 bar) and 600 kPa
(6 bar).
The supply pressure on the low pressure oxygen inlet must be less than 150 kPa (1.5 bar).
Power supply
CAUTION: To avoid the risk of electric shock, this equipment must only be connected to a
grounded power outlet.
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).
Electrical isolation is accomplished by disconnecting the equipment from the power outlet. According-
ly, do not place the equipment in a position that would make it difficult to use this disconnect device.
The ventilator has an internal battery. It must be plugged into the mains on a regular basis in order to
keep the internal battery sufficiently charged.
In the event of any doubt about the condition of the mains power supply cable, use the device on its in-
ternal battery.
Do not use antistatic or electrically conductive tubing.
The user must not touch the patient and the equipment enclosures at the same time.
Modifications to the EM system require an assessment of their compliance with the requirements of
standard IEC60601-1.
IP Protection
To ensure the IP protection level of the device is maintained during normal use, it is essential that the
power cable is plugged in and all removable components (air filter, expiratory assembly, O2 sensor
cover and the rear plastic panel) are fitted in place.
Electromagnetic compatibility
Monnal T75 complies with the EN 60601-1-2 standard on the electromagnetic compatibility of medical
devices.
This device requires specific precautions as regards EMC. It must be installed and put into operation
in accordance with the EMC information provided in this user manual.
The ventilator functioning can be impaired by the use of appliances in its immediate proximity, such as
diathermic devices, high frequency electro-surgery units, defibrillators, cell phones or, more generally,
by electromagnetic interference that exceeds the levels specified in the EN 60601-1-2 standard.
Monnal T75 should not be placed next to or on top of this equipment. If it is not possible to do other-
wise, Monnal T75 should be monitored to make sure that it operates correctly where placed.
Do not use this ventilator in a specifically magnetic environment (MRI, etc.).
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1 Before use
Replacing a cable or internal component that is not provided by Air Liquide Medical Systems, may lead
to a rise 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 or technical support.
Devices connected to the inputs and signal outputs must comply with the 60601-1 Standard, Edition 2.
Commissioning
The device must not be put into service immediately after storage or transportation where the temper-
ature 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
checking process in the appendix (see Checklist on page 135).
Use
The manufacturer has provided solutions for most of the possible malfunctions of the ventilator, and
these are normally covered by the internal monitoring system. It is nevertheless recommended, in case
of complete patient dependence to provide an additional and fully autonomous system which can be
used to check the effectiveness of 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 manufactur-
er accepts no responsibility in the event of an incident.
Do not expose the device to direct sunlight.
Do not use the Monnal T75 in a hyperbaric chamber. It is not reccommended to push the pulmonary
ventilator by its top when fitted on its trolley. To move, push using the handle (at the base of the venti-
lator)
The device and its accessories (masks, circuits, etc.) are Latex Free in order to avoid the risk of allergic
reactions.
The air inlets behind and under 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.).
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 endotracheal tube, mask, patient circuit, expiratory valve, humidification chamber, and the probe
or nebulizer adapters are part of the air pathway that may be contaminated under normal and sin-
gle-fault conditions by body fluids, secretions or gases exhaled by the patient.
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Monnal T75 user manual
Maintenance
• The ventilator must be checked regularly. To schedule and record maintenance operations, refer to
the maintenance form in the appendix.
In accordance with IEC 60601-1 (Annex A, Subclause 7.9.2.6):
“The instructions for use can contain a statement saying that the Manufacturer, assembler, in-
staller or importer considers himself responsible for the effect on basic safety, reliability and per-
formance of the ME equipment or ME system only if:
• appropriately trained personnel carry out assembly operations, extensions, readjustments, modifi-
cations or repairs;
• the electrical installation of the relevant room complies with the appropriate requirements;
• the ME equipment or ME system is used in accordance with the instructions for use.»”
The qualified technician must use only Air Liquide Medical Systems spare parts when carrying out
routine maintenance on 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 the use of the CO2 measurement probe MASIMO IRMA™ (REF. KB033600)
See CO2 Option on page 43.
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2 Description of the device
2 Description of the device
2.1 Terminology used
The expiratory assembly corresponds to the expiratory flow sensor and the Monnal EVA expiratory
valve.
The Monnal EVA expiratory valve corresponds to the valve body, the membrane, and the silicone disc.
2.2 Front panel
1. Alarm indicator light
It turns red to inform the user that an ultra or high alarm has been activated.
2. Color touch screen (10.4 inches)
This is the user interface and it enables to adjust all the ventilation parameters.
3. Control wheel
This is used to adjust and validate the parameters
4. AC power supply indicator light
It illuminates when the device is connected to the mains.
5. CO2 measurement probe connection (only for KB033600)
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Monnal T75 user manual
6. Expiratory assembly and expiratory limb connection
7. Expiratory assembly eject button
8. Ambiant air intake
9. Pneumatic nebulizer supply connection
10. Inspiratory limb connection
2.3 Right-hand side
Oxygen Cell
11. O2 sensor access cover
Oxygen access closed :
11
12. O2 sensor position
Oxygen access closed :
12
2.4 Left-hand side
Expiratory assembly
16

2 Description of the device
13
14
13. Expiratory assembly built into the device
14. Electrical connection with the hot wire flow sensor (expiratory assembly withdrawn)
2.5 Rear panel
15
16
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Monnal T75 user manual
15 RS232 connections 16 Video output connection
17 Low pressure oxygen inlet 18 Cooling wings
19 High pressure oxygen inlet 20 Access to internal battery
21 AC power supply connector 22 AC power supply connector
23 Alarm transfer connector 24 On/Off button
25 Patient air intake filter 26 Monnal Clean’ in filter
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3 Installation and commissioning
3 Installation and commissioning
3.1 Unpacking
Take the ventilator out of the packaging and place it on a table.
Unwrap the accessories supplied with the ventilator (see Items included in the package on page
96).
CAUTION: The ventilator weighs approximately 16 kg:
• Apply safe lifting procedures when installing it.
• For installation on a horizontal support, ensure that the horizontal support can bear the
weight of the unit. Check that the assembly is stable.
3.2 Connections and commissioning
3.2.1 Power supply
This ventilator may be used with various sources of electrical power (see Electrical power sources on
page 105):
• AC power supply;
• Power supply connected to an external DC source (external battery);
• Power supply connected to an internal DC source (internal battery).
To turn on the ventilator, plug it into a grounded AC power outlet.
CAUTION: Always check that the electrical network is compatible with the specifications in
this manual.
Check that the device preventing the mains plug from being pulled out is operative.
3.2.2 Oxygen supply
To supply FiO2 above 21%, connect the low or high pressure inlet of the ventilator oxygen to an avail-
able source, via an appropriate connection.
If this oxygen source is a cylinder, it must be equipped with a pressure reducer to suit the allowable
pressure range (2.8 to 6 bar).
CAUTION: 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
for intra-hospital transport.
CAUTION: To prevent the low pressure O2 fitting becoming detached, ensure the input pres-
sure applied to the low pressure oxygen inlet is less than 150 kPa (1.5 bar).
3.2.3 Assembly of patient circuit and accessories
Connect the patient circuit to the ventilator and the humidifier (if used):
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Monnal T75 user manual
27 28
•Connect the expiratory limb of the patient circuit to the expiratory valve of the ventilator: (27).
•Connect the inspiratory limb of the patient circuit to the inspiratory outlet cone of the ventilator:
(28).
CAUTION: Make sure to limit dead space while installing patient circuit and accessories.
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 to use patient circuits equipped
with water traps when using a humidifier.
2
1
1Y-piece 2Double-limb patient circuit
CAUTION: Empty the water traps regularly during ventilation.
When using the equipment on a patient for the first time, make sure that you follow the hospital’s hy-
giene protocol for new single-use equipment or adequately sterilized reusable equipment. The acces-
sories and consumables (patient circuit, masks, expiratory valves, adapters, nebulizer, etc.) are gener-
ally available in single-use and autoclavable versions.
CAUTION: Reusing single-use accessories or consumables carries the risk of patient cross-
contamination.
3.2.4 CO2 Measurement Probe
See CO2 Option on page 43 (for ref. KB033600).
3.2.5 Humidifier
If the ventilator is used with a humidifier ensure that it is always placed lower than the ventilator and
the patient.
Empty the water traps regularly in order to limit condensation in the pipes.
20