MONNAL T60 User Manual sw ver V2.5.x Rev 7 Jan 2018.pdf
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User manual
Software version V2.5.x
www.device.airliquidehealthcare.com
EN
YL180117 - Rev 7 - 2018-01
MONNAL T60
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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.
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.
Unpacking.............................................................................................................................................................................. 15
Connections and commissioning.................................................................................................................................. 15
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.
IV.5.1.
IV.5.2.
IV.6.
IV.7.
IV.8.
IV.9.
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.
Start-up screen.....................................................................................................................................................................21
Ventilation screen................................................................................................................................................................24
Home screen (current ventilation).................................................................................................................................25
Ventilator controls...............................................................................................................................................................26
New patient...........................................................................................................................................................................28
Selecting the patient category....................................................................................................................................................................................................................28
Selecting the patient height and gender.............................................................................................................................................................................................29
Emergency ventilation start-up..................................................................................................................................... 30
Start / stop ventilation....................................................................................................................................................... 31
Shutting down the unit.......................................................................................................................................................32
Ventilation modes................................................................................................................................................................33
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.
IV.10.
IV.11.
IV.12.
IV.13.
IV.13.1.
IV.13.2.
PRVC (Pressure-Regulated Volume Controlled).........................................................................................................................................................................42
PS - PRO (= Pressure Support - Pro).....................................................................................................................................................................................................43
PSIMV (Synchronized Intermittent Mandatory Pressure Monitored Ventilation)...............................................................................................44
CPV: Cardio-Pulmonary Ventilation............................................................................................................................. 45
Oxygen therapy....................................................................................................................................................................47
Keeping alarm settings and thresholds...................................................................................................................... 48
Displaying the curves ....................................................................................................................................................... 50
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.
IX.1.1.
IX.1.2.
IX.1.3.
IX.1.4.
IX.2.
IX.2.1.
IX.2.2.
IX.2.3.
IX.2.4.
IX.3.
IX.3.1.
IX.3.2.
IX.3.3.
IX.4.
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.
Operation.............................................................................................................................................................................. 98
Pneumatic system................................................................................................................................................................................................................................................98
Ventilation function...............................................................................................................................................................................................................................................99
Air/O2 mixture ..........................................................................................................................................................................................................................................................99
CO2 monitoring.................................................................................................................................................................................................................................................... 100
Electrical power sources............................................................................................................................................... 100
Managing the power supply...................................................................................................................................................................................................................... 100
AC power supply .................................................................................................................................................................................................................................................101
Auxiliary battery and internal battery....................................................................................................................................................................................................101
Battery status indicator LED......................................................................................................................................................................................................................103
Inputs and outputs........................................................................................................................................................... 104
Video output............................................................................................................................................................................................................................................................104
USB Connections ..............................................................................................................................................................................................................................................104
Connectivity to hospital networks.........................................................................................................................................................................................................105
Performance and characteristics............................................................................................................................... 106
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.
XI.2.1.
XI.2.2.
XI.3.
Checklist..............................................................................................................................................................................133
Expiratory assembly cleaning protocol.....................................................................................................................134
Monnal EVA autoclavable expiratory assembly......................................................................................................................................................................... 135
Monnal EVA single-use expiratory assembly............................................................................................................................................................................... 135
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).
10
• 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
16
17
II.4. Left-hand side: Turbine air inlet
panel
15
18
14
19
20
24
23
13
21
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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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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Monnal T60
7
5
8
6
9 10
11
12
13
1
14
2
15
16
3
17
18
1
2
3
4
5
19
Zone to define the patient characteristics. See
section “IV.5 New patient”.
Emergency ventilation access key in VC
mode.
Key to access 100% O2 in PSV non-invasive
ventilation (NIV) mode
Key to access other available Ventilation
Modes
Zone to define the category of patient to be
ventilated (adult, child or infant)
Monitoring screen key: to increase the display area of curves and trends
20
11
Alarm banner: Alarm display and software version
zone
12
Day / Night key (brightness setting)
13
Screen lock key
14
Automatic test launch key
15
180° key:
6
7
8
AC power connection status
Internal battery status symbol
Auxiliary battery status symbol
16
17
18
9
10
Audible alarm inhibit key
19
20
Alarm indicator
4
rotates the screen through 180°
Menu access key
Unit Shutdown key
Software version / serial number / counters /
current date & time
CPAP mode access button.
Oxygen therapy function key
Buttons (2) and (19) can be configured. The illustration above shows their default configuration. See “IV.17.5. Key configuration on the home screen”, page 68.
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Installation and commissioning
Screen - CPV option enabled
If the CPV option is enabled, the ventilation mode is displayed on the home page, as shown here.
Key to access CPV mode
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Monnal T60
IV.2. Ventilation screen
1
2
3
4
6
7
1
8
Display of the time elapsed since a ventilation
mode was first activated.
9
7
10
11
12
Display curves (1 to 8 configurable)
The counter resets to zero for each new patient, and after 18h ventilation.
2
3
4
5
6
The counter display turns red after one hour’s
ventilation.
Monitored ventilation parameters
100% O2 key
Trends access key
Home screen access key: returns you to
the home screen. Saves the ventilation-related
functions: settings and measured parameters
Current ventilation mode and key to access
the change of ventilation modes
Ventilation settings
Arrow to access the rest of the settings for the
current ventilation mode
Arrow to access the rest of the monitored ven10
tilation parameters
Display type of patient ventilated (adult, child,
11
or infant)
8
9
12
Ventilation start key [
key [
] or ventilation pause
]
The settings are not displayed when the device is started up. They are displayed when the Ventilation
Modes button is selected or when a ventilation has already been launched.
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Installation and commissioning
IV.3. Home screen (current ventilation)
The set parameters are monitored
This screen is displayed when you press the Home key. It is the same as the start-up screen, but it keeps the
ventilation-related functions: settings and monitored parameters. Ventilation continues.
The current ventilation settings are maintained
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Monnal T60
IV.4. Ventilator controls
Function buttons
The desired function is activated by simply pressing the appropriate button. Its activation is indicated by a yellow LED. Press again to deactivate the
function (the yellow LED is extinguished).
Ventilation settings
The mode setting is entered or modified by simply
pressing the screen. The value is highlighted. To
modify the value, turn the control wheel and then
confirm by pressing the control wheel.
Monitoring blocks
These panels are accessible on two pages using
the
arrow. The alarm thresholds are represented by the following symbol:
. The threshold is
selected by pressing this up or down symbol according to the threshold to be adjusted. Adjust the
value by turning the control wheel, and press the
control wheel to validate.
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