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3 - 12/2012
Maintenance manual EN
This maintenace manual is valid for softawre versions higher than or equal to
v1.0.0
www.airliquide.com
www.airliquidemedicalsystems.com
Introduction ...................................................................................................................................................... 3
symbols used in this maintenance manual .................................................................................................. 4
Typography ...................................................................................................................................................... 4
ACRONYMS & ABBREVIATIONS ................................................................................................................... 4
Symbols and markings on the device ........................................................................................................... 5
GENERAL SAFETY INSTRUCTIONS .............................................................................................................. 6
REGULATORY REQUIREMENTS ................................................................................................................. 10
1. description of OPERATION................................................................................................................ 12
1.1. Exterior description ........................................................................................................................ 12
1.1.1. Front view 12
1.1.2. Right-hand side: patient interface 14
1.1.3. Left-hand side: fluid interface 14
1.1.4. View from below 15
1.2. Principle of operation ..................................................................................................................... 16
1.3. Functional description.................................................................................................................... 16
1.3.1. Function flowcharts 16
1.3.2. Electronic sub-system 17
1.3.3. Mechanical sub-system 21
1.3.4. Pneumatic sub-system 26
1.4. Pneumatic operation ....................................................................................................................... 27
1.4.1. – Operation of ventilation 27
1.5. Electrical power sources ................................................................................................................ 30
1.5.1. Power supply management 30
1.6. Description of the pneumatic components .................................................................................. 32
1.6.1. Micro blower unit (T) 32
1.6.2. Mixer unit 33
1.6.3. Expiratory valve 34
1.6.4. Hot wire expiratory flow sensor (FS2) 36
1.6.5. Mass flow sensor (FS1 and FS3) 36
1.6.6. Pressure sensors 37
1.6.7. FiO2 CELL (O2S) 38
1.6.8. Temperature sensor (TS) 39
1.7. Description of circuits .................................................................................................................... 40
1.7.1. Pneumatic circuits 40
1.7.2. Electrical wiring 40
2. Equipment required for maintenance ............................................................................................... 42
3. Access to the maintenance menu ..................................................................................................... 43
4. software update .................................................................................................................................. 44
4.1. Accessing the update screen ........................................................................................................ 44
4.2. Connection....................................................................................................................................... 45
4.3. Preparing the pc 45
4.4. Downloading .................................................................................................................................... 46
4.5. Checking the downloading ............................................................................................................ 49
5. Downloading the black box ............................................................................................................... 50
5.1. Black box downloading procedure via usb key ........................................................................... 50
5.2. Hardware configuration via USB cable ......................................................................................... 50
5.3. Accessing the download screen ................................................................................................... 51
5.4. Black box downloading procedure ............................................................................................... 51
2
6. Downloading the white box ............................................................................................................... 53
6.1. Hardware configuration .................................................................................................................. 53
6.2. Accessing the download screen ................................................................................................... 53
6.3. White box downloading procedure ............................................................................................... 54
7. Annual preventive maintenance........................................................................................................ 56
7.1. Definition .......................................................................................................................................... 56
7.2. Flowchart ......................................................................................................................................... 57
8. Corrective maintenance ..................................................................................................................... 58
8.1. Flowchart ......................................................................................................................................... 58
8.2. Procedure for emergency shutdown ............................................................................................ 59
8.3. Alarm messages .............................................................................................................................. 59
8.4. Diagnostic aid list of alarms .......................................................................................................... 59
9. Disassembly/reassembly procedures .............................................................................................. 74
9.1. Reminders ........................................................................................................................................ 74
9.2. Disassembly .................................................................................................................................... 75
10. Calibration and operating checks ..................................................................................................... 87
10.1. Introduction ..................................................................................................................................... 87
10.2. Checking or replacing parts........................................................................................................... 88
10.3. Functional check of touch screen ................................................................................................. 89
10.4. Functional check of usb port ......................................................................................................... 89
10.5. Sensor calibration ........................................................................................................................... 91
10.6. Ventilation check ............................................................................................................................. 92
10.7. Alarm checks ................................................................................................................................... 94
10.8. Switching off the unit...................................................................................................................... 95
11. CALIBRATION ..................................................................................................................................... 96
11.1. Access to the calibration screen ................................................................................................... 96
11.2. Using the calibration screen .......................................................................................................... 96
11.3. Calibrating the machine ................................................................................................................. 96
11.4. Automatic tests ............................................................................................................................... 97
11.5. Calibration........................................................................................................................................ 99
12. SPARE PARTS AND CONSUMABLES ............................................................................................ 106
12.1. Spare parts..................................................................................................................................... 106
12.2. Consumables ................................................................................................................................. 111
12.3. Tools ............................................................................................................................................... 112
13. Electrical safety checklist ................................................................................................................ 113
14. MONNAL T60 ‘RETURN TO SERVICE' SHEET ............................................................................... 114
3
INTRODUCTION
This document is a maintenance manual, and does not serve as a replacement for the
user manual.
It contains technical information belonging to Air Liquide Medical Systems, which may
not be divulged except with the company’s prior consent.
DWarning
Alerts the user to the possibility of a technical problem or device malfunction occurring,
associated with the use, proper or improper, of the device.
Note
TYPOGRAPHY
Font Example Function
Use of oxygen
Precautions in case of oxygen leakage:
- Do not smoke
- Avoid flames and sparks
- Disconnect the oxygen source
- Ventilate room during leakage and at least 20 minutes after leakage.
- Ventilate clothes worn.
The machine must not operate in the vicinity of any incandescent source.
This respirator should not be used with inflammable anaesthetic agents or explosive
products.
Do not use the machine with any items contaminated by flammable substances (grease,
oil, etc.).
The components inside the machine were degreased before delivery, or use oxygen-
compatible grease. Do not grease or lubricate any part of the machine.
Only medical-grade oxygen must be used, i.e. it must be dry and dust-free
(H2O < 20 mg/m3).
The supply pressure must be between 280 kPa (2.8 bar) and 600 kPa (6 bar).
We recommend that all oxygen sources be disconnected from the machine when it is not
in use.
Electromagnetic Compatibility
The functioning of the respirator may be affected if other equipment is being used in the
vicinity of the device, such as diathermy equipment, high-frequency electro-surgery,
defibrillators, mobile phones or, more generally, by electromagnetic interference exceeding
the levels set under the standard EN 60601-1-2.
Do not use this respirator in a magnetic environment (such as MRI, NMR, etc).
Commissioning
The device must not be commissioned immediately after storage or transport under
temperature and humidity conditions different from the recommended conditions of use.
After each use, check that the audible and visual alarm is operating properly, and carry out
the checks listed in the appendix (See Section IX.1, ‘Checklist’, in the User Manual).
Use
The manufacturer has anticipated most of the possible instances of malfunction which might
occur on this respirator, and these are normally monitored by the internal surveillance
system; nevertheless, it is recommended that where the patient is totally dependent on the
device, that a supplementary system is provided, wholly independently, to monitor the
effectiveness of the ventilation, as well as an emergency breathing device such as an
appropriate manual insuflator.
If the accessories employed by a user are not in conformity with the manufacturer’s
instructions, then the manufacturer is absolved of all responsibility in the event of an
incident.
Do not expose the device to direct sunlight.
The device and its accessories (masks, circuits, etc.) are latex-free in order to avoid any
allergy risk.
The air inlets at the rear and the side of the device must be clear of any obstruction.
For the device to operate from ambient air, a HEPA filter must be used at the respirator inlet,
as recommended by Air Liquide Medical Systems.
Do not use the respirator in an explosive or nicotine-laden atmosphere (cigarette smoke,
danger, etc.).
Persons intending to operate this respirator must be trained in its use.
Only those who have fully read and understood the user manual are authorised to handle
and use this respirator. This manual was written for the purpose of providing all the
information required to use this respirator, but it cannot replace a medical prescription, which
is essential in order to determine the appropriate settings for the needs of the patient.
Transport
During transport, it is recommended that the device be used in its carrying case. The case
must be firmly secured in the vehicle via the strap loops provided for the purpose.
The device must not be subjected to any brutal impact when not in its carrying case.
Exclusively use the carrying case recommended by Air Liquide Medical Systems.
Maintenance
This respirator should be checked regularly. To plan and keep a record of all maintenance
operations, refer to the maintenance record in Appendix.
According to EN 60601-1 standards (See Appendix A, Section 6.8.2.b):
When using the IRMA probe, place the adapter so that its BLUEYETM windows are vertical so that
patient secretions do not accumulate on the windows:
When using the IRMA probe, place the adapter so that moisture and secretions do not accumulate in it
due to the action of gravity.
Do not use any sprayed medication with the IRMA probe, because the spray might affect IR
transmission through the windows of the adapter.
Never sterilize 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 10°C or above 40°C.
When using the IRMA probe, be sure to connect it to the machine before connecting it to the patient.
Directives
Directive 93/42/EEC of the Council of 13 June 1993 concerning medical devices.
Directive 2002/96/EC of the European Parliament and the Council of 27 January 2003
concerning waste electrical and electronic equipment (WEEE)
Standards
The compliance of Monnal T60 with the essential requirements of Directive 93/42 is based
on the following standards:
IEC 60601-1:2000 and appendices | Electromedical Devices – Part One: General Safety
Rules
IEC 60601-1-2:2007 | Electromedical Devices - Part 1-2: General Safety Rules – Collateral
Standard: Electromagnetic Compatibility – Requirements and Tests
IEC 60601-2-12:2001 | Electromedical Devices - Part 2-12: Particular requirements for the
safety of lung ventilators – Critical care ventilators
NF EN 794-3:1998, A1:2005 A2: 2009 | Lung ventilators: - Part 3: Particular requirements for
emergency and transport ventilators.
NF EN 1789: 2010 section 6.3 requirements for medical equipment | Medical transportation
vehicles and their equipment.
EN 13718-1: 2008: Part 1: Requirements for medical devices used in air ambulances.
Disposal of components
4 3
5 6 7
10 11 12
8 9
FOOT SIDE
13. Electrical connection with the hot wire expiratory flow sensor (expiratory
assembly removed)
14. Feet
14
13
16. Port for exhaled patient gas / electrical connection to hot wire flow sensor
16
20
29 31
30
Electronic sub-system: this supplies the energy needed to power all electrical
components and runs the overall system (sending instructions to actuators, taking
measurements, etc.).
Pneumatic sub-system: this performs the essential function of the device, i.e.
ventilating the patient.
Mechanical sub-system: ensures a robust link between all the components, and
provides the user with an interface combining qualities of design and ergonomics.
Software sub-system: this is the system’s intelligence.
O2
Exhaled air
O2 HP Expiratory
Mixer Interconnection board assembly
O2 LP
8.4’’ screen
+ 5-wire resistive touchscreen
s Extractible battery Internal battery
RGB bus
u
b
Back B
light
G
R Docking
station
Encoder wheel
Ctrl dalle Charger DC
AC-DC
DC/DC
power supply
Loudspeaker converter 230Vac-24Vdc
Alarm LED
Motor ctrl
o
Ext batt LED to
Int batt LED r
ct
VGA rl r
Blower
USB A e
w
USB B
lo
B
Fan
Processors
- The monitor: this sub-system is the processor dedicated to the MMI (man-machine
interface). It allows for full management (cf. display interface), integrates the electronic
stages linked to safety and to redundancy of commands for particular elements (audible
and visual alarms, pressure metering, etc.) and handles the communications with the
ventilator.
The power card provides the energy to the ventilation board and to all the pneumatic
actuators.
The power board handles automatic switching between these different power sources and
informs the microprocessor board of the sources present.
In the absence of an electrical network, the power supply module will automatically switch
to the interchangeable battery and then, if necessary, to the internal battery if the
interchangeable battery is absent or its charge is too low.
The screen on the MONNAL T60 comprises an 8.4” TFT colour display equipped with LED
back-lighting. These LEDs are powered by a 26 V voltage from the power supply.
The user interface is provided by means of a 5-wire resistive 8.4” touch screen and its
controller. The controller transforms the screen position of the user’s finger into Cartesian
coordinates (x, y). The system for adjusting and validating parameters is handled by a
coding dial (standard 16-position encoder).
The front panel also contains the indicator lights for the system alarms (concerning
ventilation or technical issues) as well as the presence of the various voltage sources and
power supply status.
CHASSIS
The chassis is the central mount for the system, and most of the mechanical and
pneumatic elements are secured to it, and positioned as follows:
Chassis
Battery
interchangeable
Internal battery
This assembly is the main pneumatic unit, comprising the inspiratory and expiratory
branch. It includes:
● The inspiratory flow sensor: This assembly consists of the sensor and the
electronic board that filters the signals
received from the sensor.
● An oxygen cell.
● Two non-return valves, of which one acts as the backup air inlet
Pressure sensors
Flow sensor
BATTERY HOUSINGS:
These housings are used to insert the internal battery, secure it mechanically, and receive
the interchangeable battery.
This is the low- and high-pressure oxygen inlet of the machine. It is equipped with two non-
return valves, an oxygen pressure sensor, a proportional solenoid valve, and a flow sensor
used to adjust it to obtain the desired gas mixture. This unit is connected to the micro
blower unit via a polyurethane hose. The air-oxygen mixture is created inside the micro
blower unit.
INTERCONNECTION BOARD:
This board is used to connect all the actuators, sensors, batteries, and the cooling fan.
The patient-machine interface on the right-hand side of the device includes the inspiratory branch
fitting, the expiratory valve assembly reception area, and the etCO2 probe connection.
The front panel is the upper part of the external casing of the device. It incorporates the
entire human-machine interface, including the display screen, the 8.4-inch touch screen,
the microprocessor/power board, the rotary knob, and the indicators associated with the
system alarms and AC power supply presence.
Key
- INSPIRATORY PHASE
The main component during the inspiratory phase is the micro blower unit (T) which
regulates the flow via the flow sensor (FS1) when volume-controlled mode is selected, or
via the pressure sensor (PS1) during pressure-controlled mode.
At the same time, solenoid valves (V3) and (V2) are open and closed, respectively, so that
the pressure of the micro blower unit is applied to the membrane (M1) of the expiratory
valve, thus forcing the air sent by the micro blower (T) towards the patient only.
- EXPIRATORY PHASE
In this phase, the patient expires the gases inspired in the previous phase, and the device
is asked to regulate at a pressure level determined by the settings (PEEP).
With this in mind, the PEEP regulating proportional solenoid valve (V2) regulates the
expiration pressure via the pressure sensor (PS1).
Meanwhile, the micro blower unit (T) regulates the flow rate via the flow sensor (FS1) to a
rinse flow of 5 L/min. This limits reinhalation and ensures fast detection of an inspiratory
demand.
During leakage ventilation , NIV type, the micro blower unit (T) is likely to increase the
rinse flow rate: it then switches to an ‘on-demand valve’ mode. The aim of this function is
to compensate for leaks to maintain the PEEP in the circuit.
- AIR / O2 MIXTURE
The O2 concentration of the gases administered to the patient depends on the source
connected to the device. A distinction is in fact drawn between operation with an O2
network and with a concentrator.
- OPERATION ON AN O2 NETWORK
To be able to operate correctly, the pressure at the O2 intake terminals (O2 HP) must be
between 2.8 and 6 bars. The O2 is then filtered via F3.
The proportional solenoid valve (V1) provides oxygen enrichment to the mixture by
regulating the flow rate (FS3), with the set-point being proportional to the upstream flow
rate (FS1) and according to the FiO2 rate setting.
- OPERATION ON A CONCENTRATOR
The device is equipped with a ‘low pressure’ connector to operate with a concentrator
(inlet via the filter (F1)). The principle of precise control of the O2 concentration applied at
high pressure is maintained during operation on a low-pressure source: the device then
continuously delivers a mixture at the correct FiO2.
However, the concentration of the mixture might not be reached, because it depends:
- On the type of concentrator and its settings (the O2 flow rate delivered by the
concentrator is often low, and its O2 concentration is variable, between 90 and 100%)
- Ventilation parameters
Below are the maximum concentrations that can be obtained with different concentrator
flow rates (assuming their O2 concentration is 100%) according to the volume per minute
of a patient ventilated at a frequency of 15 bpm.
FiO2 (%)
10L/min
5L/min
2.5L/min
Whatever the function mode for the device, the oxygen sensor (O2S) ensures monitoring of the
concentration in the circuit.
This sensor is a chemical cell that carries out an electrolytic reaction. The current produced is
proportional to the partial pressure of oxygen, however, a compensation of this pressure is applied
each time the automatic tests are launched. Ambient humidity similarly influences the
measurement of oxygen, at a rate of -0.03% per %Hr at 25°C (see VIII.4.1 Technical
characteristics – Measured parameters).
The electrical characteristics of each source are described in Chapter VIII.4.1 (Electrical
specifications).
If the device has stopped suddenly during ventilation (at the end of battery life, for
example), it relaunches ventilation directly using the last parameters saved when the
device is reconnected to the mains and started up again.
AC POWER SUPPLY
The presence or absence of the AC power supply or the external DC voltage source is
indicated by two pictograms.
This is also indicated by a blue LED on the front panel of the device.
The charge status of both batteries is indicated in the upper left-hand part of the screen:
When the unit is connected to the mains or an external battery, the unit's internal battery
recharges. When internal battery charging is complete, the machine charges the
interchangeable battery, if any. A special pictogram appears on the screen, representing
the progress of light segments:
D In the event of operation at a high or very low ambient temperature, a safety device
might interrupt the battery charge. An ‘excessive battery temperature’ alarm is triggered.
This can have a significant effect on the charging time and operating duration of the
battery.
The charging time per battery is approximately 2 hours 20 min (at 25°C ambient).
When the machine is switched off but connected to the mains or an external DC power
source, batteries are automatically recharged .
If the unit cannot recharge the battery because the battery is absent or defective, the
following pictogram appears on screen:
Battery unavailable
Air intake
Mixture outlet
Oxygen inlet
ROLE
OPERATION
O2 HP
To micro
blower unit
PS4
O2 BP
ROLE
The proportional solenoid valve (V1) associated with the flow sensor (FS3) enriches the
mixture with oxygen.
QO2=Qmixture x (FiO2-0.21)
0.79
OPERATION
V1 closed at rest.
V1 is controlled by a signal with the following characteristics:
- Amplitude PWM: 0 - 12V;
- PWM: 20 kHz.
ROLE
The function of the expiratory valve is to pressurise at patient level during the inspiratory
phase and to control the patient’s expiration.
OPERATION
During expiration, this valve is open to a greater or lesser degree to control the PEEP level
or the expiration flow.
The expiratory valve comprises a membrane, to which a pressure is applied such as to
vary the size of the opening through which the expired gases pass.
During insufflation, this valve is closed (micro blower unit pressure applied to the
membrane).
Membrane
INSUFFLATION
Patient pressure
The autoclavable expiratory valve tolerates 50 sterilisation cycles. A unit serial number
on the body of the valve advises the date of manufacture of the elements, and if necessary
makes it possible to track the number of cycles gone through.
This sensor measures the gas passing through the expiratory branch of the patient circuit.
OPERATION
The sensor comprises a resistance wire placed in the flow, and passed through by a
current at a constant level which increases the temperature of the wire in a continuous
manner. The result of this is a convection heat exchange between the wire and the flow of
gas, and the resulting temperature of the wire is indicative of the speed of the flow.
During automatic tests of the device, the hot wire expiratory flow sensor is calibrated.
During ventilation, the zero is periodically recalibrated (every 2 minutes).
This sensor is used to measure the inspiratory flow rate and to regulate the mixture.
OPERATION
The sensor measures heat transfer between a point A and a point B situated on one side
and the other of a heating element. The temperature difference is proportional to the mass
flow.
A Heating element B
TA TB
Gas
No flow
Temperature
With flow
D The operation of the mass flow sensor is affected by atmospheric pressure. The
atmospheric pressure sensor (APS3) adjusts the value measured by mass flow sensors
FS accordingly.
ROLE
Differential pressure sensor (PS1, PS2): gives access to the turbine pressure and checks
that the pressure is properly regulated in the patient’s airways.
OPERATION
Pressure sensors PS1, PS2, and APS3 are piezoelectric.
Piezo-electricity is the special quality which certain crystals such as quartz possess, of
becoming electrically polarised when subjected to mechanical stresses. The quantity of the
electrical charges produced is proportional over a wide range to the pressure exerted.
This type of pressure sensor has a very short response time.
PS1 and PS2 are differential pressure sensors, i.e. they measure the difference between a
given pressure value and a reference pressure (in this case, atmospheric pressure).
APS3 is an absolute pressure sensor; it measures the pressure above absolute zero.
PS4
ROLE
O2 pressure sensor (PS1): detects the presence or absence of the oxygen feed supply.
OPERATION
The pressure sensor is piezoelectric. It operation is identical to that of sensors PS1, PS2,
and APS3. It is also differential.
OPERATION
This sensor performs an electrolytic reaction. The current produced is proportional to the
partial pressure of oxygen; however, a compensation of this pressure is realised each time
the automatic tests are launched. Calibration is automatic during the automatic tests, and
is made to 21%.
By virtue of its engineering, the lifetime of the FiO2 cell depends on the ventilator’s
consumption of O2.
The operation of the FiO2 cell is affected by the pressure (atmospheric pressure and circuit
pressure). In order to mitigate this effect, software compensation is applied, taking the
pressure sensor measurements into account.
A 10% drift in the voltage in the cell is observed for each additional 1000 metres in altitude.
For example, for a cell with a voltage of 15 mV at sea level, the voltage will fall to 13.5 mV
at 1000 metres altitude.
The ambient temperature and the patient gases affect the oxygen measurement.
Electronic compensation is applied via the temperature of the patient gases.
Ambient humidity similarly influences the measurement of oxygen, at a rate of -0.03% per
%Hr at 25°C.
This sensor monitors the temperature of the gases delivered to the patient.
It provides temperature compensation for the O2 cell.
OPERATION
The output voltage from the temperature sensor is linearly proportional to the temperature
in degrees Celsius (+ 10.0 mV/°C).
STANDARD TOOLKIT
SPECIAL TOOLKIT
Type of maintenance
Catalogue Software
Type of device Corrective
Number Update Preventive
maintenance
Test lung VS206103 X X
O2 connector removal spanner YA000700 X
BM connector removal spanner YA004400 X
Extension ribbon YR122700 X
Blower inlet cap YA018100 X X
We recommend using an external metering unit such as PF300 from IMT Medical, or
similar. This type of system simultaneously performs the function of manometer (0-5 bar,
0-100 mbar, atmospheric pressure), flow meter 0-200L/min, and oxygen meter - making it
possible to measure the following ventilation parameters: F, I/E, VTi, VTe, PEEP, PSV.
D Rotameter-type flow sensors are sensitive to altitude. Air Liquide Medical Systems
advises against their use and recommends the use of pressure-compensated flow
sensors.
Access is therefore controlled by the enabling of a code whose validity period is variable
(from 1 month to 3 years), or unlimited, according to the maintenance management mode
chosen.
To access the maintenance screen, power up the MONNAL T60. The stand-by screen
appears.
Press the knob and the centre of the touch screen simultaneously.
The following window appears when the MONNAL T60 is outside the validity period or the
first time you seek access:
A software update is simple, and requires only a few steps. This procedure describes how
to update the ventilator and monitor.
4.1. ACCESSING THE UPDATE SCREEN
In the stand-by screen, press and hold the adjustment knob and touch the centre of the
screen; a new Configuration window appears.
4.2. CONNECTION
Connect the PC to the MONNAL T60 using a USB-A male to USB-B male cable.
The first time you connect the PC, install the ALMS Maintenance Utility (‘Flashouilleur’) V.
1.3.6 or above.
- Open the file, select the ‘update’ tab (normally selected by default).
The file location should now appear in the maintenance utility window:
During the transfer, the speed, progress, and estimated time remaining are indicated.
The software is locked and cannot be stopped in the normal way:
When the procedure has been successfully completed, the ventilator may be returned to
service.
Complete the tracking sheet included in the technical note, and return it to Air Liquide
Medical Systems.
The black box can be downloaded in two ways: via a USB cable, or directly using a USB
key. The access method depends on the solution chosen.
5.1. BLACK BOX DOWNLOADING PROCEDURE VIA USB KEY
In Stand-by Mode, insert the USB key directly into the appropriate port.
MONNAL T60 then looks for the space available on the key. Wait while it does this. When
the space available on the key is displayed, press the ‘Black box’ key.
When downloading is complete, remove the key. The MONNAL T60 returns to stand-by
mode. A directory called MT60 has been created. It contains a sub-directory called 00xxx,
which is the Serial Number of the device.
Use the same physical port on the PC that is used for software downloading.
Click ‘save as…’ to select the location to which you wish the file to be downloaded.
Give it a name in the format
BN_MT60_SNxxx.his. (SNxxx is the serial number of the device.)
In the location where the file has been downloaded, rename it in the format
BN_MT60_SNxxx.his. (SNxxx is the serial number of the device.)
The white box restores the specific ventilation signals before and after the occurrence of
some technical problems, to supplement the black box data and optimize the maintenance
diagnosis.
The white box should not be downloaded unless the technical problem corresponds to an
alarm tracked by the black box.
Use the same physical port on the PC that is used for software downloading.
-Select ‘save as…’ to select a location for the downloaded file. Give it a name in the
format BB_MT60_SNxxx.xls. (SNxxx is the serial number of the device.)
You may now quit the menu and return to the Stand-by screen.
7.1. DEFINITION
Preventive maintenance conducted annually.
It consists of checking the operation of the device (see Section 9), and does not require
the use of a maintenance kit. If the automatic test results and the ventilation performance
are not satisfactory (compared to the expected data in the return to service sheet,
Section12), the device needs to be calibrated. (Refer to Section 10).
The fixed internal and interchangeable batteries and the micro blower unit are subject
to special handling.
The batteries are dealt with by measuring the battery capacity. If the capacity is reduced
by 60%, which is symptomatic of battery wear, a low-priority alarm message is displayed:
‘Internal battery defective’ or ‘Interchangeable battery defective’. The internal battery
must be replaced as soon as possible. The user replaces the interchangeable battery.
The ageing of the micro blower unit depends on several factors: speed, FiO2, ventilation
time and temperature. Using an algorithm, MONNAL T60 is able to determine the rate of
ageing, and generates a signal in the form of a low-priority alarm. Wear can also be
indicated by an alarm such as ‘VTi or PI not reached’.
Periodicity
Annual
Actions
Electrical test x
Calibration (see Section 9) optional
No
OK? Replace defective part(s)
Yes
Corrective
Automatic tests maintenance and/or
calibration
No
OK?
Yes No
8.1. FLOWCHART
Corrective maintenance
Automatic tests
Yes
OK?
No
Replace parts Calibration
Calibration screen
O2 or Insp flow
sensor Calibration of both Checks of
flow sensors
operation
Automatic tests
Solenoid valve
Electrical safety
Calibration of flow
Pressure sensor sensor tests
Complete the
Micro blower unit O2 flow sensor calibration ‘return to service’
sheet
Other components
DWhen replacing one of the following internal components on the MONNAL T60: flow
sensor, pressure sensor, solenoid valve unit, or microprocessor board, the corresponding
calibration procedure must be performed, along with the operational check (Section 9).
Y During servicing, if there is any reason to suspect that part of the device might
have been contaminated, the components concerned must be replaced.
For each alarm, the actions to be implemented are listed in order of implementation. If the
fault persists once the 1st item has been performed, move on to the next recommended
action, and so on.
If the fault persists despite checking all the points listed, please contact our technical
department.
ULTRA alarms are tracked by the white box. The white box downloading procedure is
given in Section 4.
Inhibition for 60
s on ventilation
Inhaled volume
start-up. Check the coherence of
per minute below
16 "Low VMi!!!" HIGH Triggering alarm levels with
the alarm
within 1 ventilation settings
threshold
ventilation
cycle.
Inhibition for 60
Check the level of
s on ventilation
Exhaled volume leakage
start-up.
per minute below
17 Low VMe!!! HIGH Triggering
the alarm Check the coherence of
within 1
threshold alarm levels with
ventilation
ventilation settings
cycle.
Inhibition for 60
s on ventilation
Measured start-up.
Check the coherence of
frequency below Triggered after
18 Low frequency!!! HIGH alarm levels with
the alarm 3 consecutive
ventilation settings
threshold ventilation
cycles with
Fmin.
3cmH2O or 30%
difference between P1
and P2*
-Launch automatic tests
Error -Calibrate
detected!!! -Replace the following, in
Patient pressure Immediate
19 Contact the HIGH order:
sensor 1&2 error triggering
technical Pressure sensor cable
department harness
Patient pressure sensor
-Replace the power
supply board/micro board
assembly.
Inhibition for 60
Measured Check the coherence of
s on ventilation
frequency above alarm levels with
start-up.
the alarm ventilation settings
High Triggered after
22 HIGH threshold or
frequency!!! 3 consecutive
automatic Reduce the sensitivity of
ventilation
triggering of the the inspiratory trigger if
cycles with
inspiratory trigger justified.
Fmax.
Inhibition for 60
Check the level of
s on ventilation
leakage
Inhaled volume start-up.
23 High VMi!!! HIGH per minute above Triggering
Check the coherence of
the set threshold within 1
alarm levels with
ventilation
ventilation settings
cycle.
Inhibition for 60
s on ventilation
Exhaled volume start-up. Check the coherence of
24 High VMe!!! HIGH per minute above Triggering alarm levels with
the set threshold within 1 ventilation settings
ventilation
cycle.
Inhibition for 50
s at each
Check the coherence of
change of FiO2
the alarm levels with
Measured FiO2 setting or
respect to the oxygen
26 FiO2 high!!! HIGH above the set change of
supply installed.
threshold ventilation
mode.
Run the interactive tests.
Triggering
within 5 s.
Power supply
board/micro board
assembly.
Release it.
Error
Long press on Replace the following, in
detected!!!
touch screen or Triggering order:
46 Contact the HIGH
technical touch screen beyond 30 s Touch screen.
department broken -power supply
board/micro board
assembly.
Inhibition for 60
s on ventilation
start-up.
Insufflated tidal Check the coherence of
Triggered after
48 Low VTi!!! MEDIUM volume below the alarm levels with
3 consecutive
set threshold ventilation settings
ventilation
cycles with low
VTi.
Inhibition for 60
s on ventilation Check the level of
start-up. leakage
Exhaled tidal
Triggered after
49 Low VTe!!! MEDIUM volume below the
3 consecutive Check the coherence of
set threshold
ventilation alarm levels with
cycles with low ventilation settings
VTe.
etCO2
Check the coherence of
measurement Immediate
85 etCO2 high!!! MEDIUM alarm levels with
above the triggering
ventilation settings
threshold setting
etCO2
Check the coherence of
measurement Immediate
86 etCO2 low!!! MEDIUM alarm levels with
below the triggering
ventilation settings
threshold setting
Launch the automatic
tests.
Error
Replace the following, in
detected!!! O2 pressure
Immediate order:
89 Contact the HIGH sensor out of
triggering O2 pressure sensor
technical range.
department the power supply
board/micro board
assembly.
High O2 supply O2 supply Immediate Check pressure in wall
90 HIGH
pressure!!! pressure > 7 bars triggering network.
Check remaining supply
in cylinder or pressure in
wall network.
Actual capacity of
the internal battery
Use a different unit and
Internal battery is too low Immediate
105 LOW contact the technical
defective! compared to its triggering
department
theoretical initial
capacity
Actual capacity of
the
Interchangeable interchangeable
Immediate Replace the
106 battery LOW battery is too low
triggering interchangeable battery.
defective! compared to its
theoretical initial
capacity
Check the touch screen
Error connection.
detected!!! -Replace the touch
Touch screen Immediate
107 Contact the HIGH screen
check error triggering
technical -the power supply
department board/micro board
assembly.
Triggering at
Tele-inspiratory "Inspiratory
the start of the
108 occlusion in INFO pause" respiratory
expiratory
progress function selected
phase
Triggering at
Tele-expiratory "Expiratory pause"
the start of the
109 occlusion in INFO respiratory
inspiratory
progress function selected
phase
Ventilation in Triggering after
Select a mode other than
100% 02 time > 3 100% O2 mode" more than 3
110 LOW 100% O2. Or reduce the
min with the FiO2 minutes of
FiO2 setting.
setting at 100% ventilation
Check that the unit is
being used according to
specifications
High turbine
Check the machine air
temperature!!! High micro-blower Triggering
111 HIGH inlet.
Ventilation temperature within 60 s
could stop.
Replace the filters.
(*) This check is performed in Expert Mode: Consult us for the access procedures and the expected values.
9.1. REMINDERS
Some reminders, to prevent the connectors from being damaged:
Avoid placing mechanical stresses on the sensor: its pins could snap.
POLYURETHANE TUBE
To remove a Polyurethane® tube, press the black ring, continue pressing, and
pull the pipe: the tube is easily extracted.
Installation is easy: engage the pipe in the quick-fit connector until it stops
check that the tube is sufficiently engaged in its housing (5 to 8 mm) to prevent
leakage.
ELECTRONIC BOARDS
Use an antistatic mat and a bracelet when handling electronic boards.
If the board is removed, place it solder-side down on this mat.
Handle with care and do not subject it to any mechanical stress.
The microprocessor board must be removed/reinstalled with care: tools must not slip, at the
risk of damaging the components or tracks nearby.
STATIC ELECTRICITY
Touch an earth connection before touching a component in order to release any electrostatic
charge.
9.2. DISASSEMBLY
Y Before commencing disassembly, switch off the unit, disconnect the mains cable,
remove the interchangeable battery, and remove all accessories.
Screw
White cover
Remove the three screws under the device on the handle side.
Screws
3
4
1
2
Screws
Loudspeaker
Nuts
Post (a)
Screws
Screen
Encoder
Unless otherwise specified, it is usually necessary to remove the inspiratory patient flank
to gain access to the internal pneumatic components.
Screws
Disconnect the etCO2 ribbon cable from the interconnection board (7)
Carefully disengage the patient flank, firstly from the inspiratory flow sensor side (a)
and then the expiratory valve side (b).
Disconnect
- The blue expiratory valve control hose (8)
- The cable harness of the expiratory flow sensor on the interconnection board (9)
- The cable harness of the ventilator on the interconnection board (10)
Tabs Grooves
Screws
Screws
Mounting
The length of each cable harness depends on the sensor’s position on the mounting.
They cannot therefore be interchanged after the assembly has been mounted.
Remove the two mounting screws and the small transparent insulating card
Disconnect all the connectors, starting with the internal battery connector.
Each connector can be identified because its name is written on the board.
For reassembly, refer to Section 1.6.2
Screws MMI connector
Remove the oxygen cell (OS2) using the special tool provided
Remove the patient flank
Remove the two securing screws
Pull the interconnection board slightly clear to access the connectors
Disconnect the associated EVPep connector (V2) and the pause on/off relay (V3)
Tool
O2 sensor location
V3
V2
TS
Screws
Seal
Black ring
Mixer unit
Micro-blower unit
Connection
Y – When reassembling, carefully reposition the black ring that serves as a seal on
the O2 connector in the corresponding flank.
Remove the five screws from the oxygen flow sensor (FS3) cover.
Separate the assembly into three parts
Disconnect the sensor from the metal box
Screws
V1
FS3
PS4
The oxygen and PEEP proportional valves are removed/reinstalled after removal of
both mounting screws by rotation/translation.
Bracket Screw
10.1. INTRODUCTION
Operating checks are usually carried out without calibration.
If a stage of the operating check produces an invalid result, calibrate the element(s)
concerned.
In the event that a manometer calibrated in cmH2O is being used, apply the following
correction:
1 cmH2O = 0.981 hPa
1 hPa =1.02 cmH2O
Labels/Accessories Actions
Mains (AC) power adapter With MONNAL T60 off, check the integrity of the assembly
Check its condition (good condition, no sign of cracks, hot
Expiratory flow sensor
wire OK)
Check its condition (no sign of cracks), presence of
Expiratory valve
membrane and silicone disc
etCO2 connector
Function Actions
Connect the AC power supply
Occasional red alarm indicator, presence of audible
Initialisation
alarm, blue mains indicator and green battery indicator
Proper operation of cooling fan (check by listening)
Apply power to the device and check that it beeps
Sound alarm
No alarms are present
Interchangeable battery
Internal battery
AC (mains) power
Sensors Comments
P TESTER
Vt, f, etc…
TEST lung
ADULT PATIENT
Adult patient circuit
1L test lung:
- Rp = 5
- Compliance = 30 ml/cmH2O
VPAC Mode
Ventilation parameters Targets
IP (cmH2O) = 20 18 ≤ IP (cmH2O) ≤ 22
Fmin (bpm) = 10 9 ≤ F (bpm) ≤ 11
PEEP (cmH2O) = 3 2 ≤ PEEP (cmH2O) ≤ 4
FiO2 = 60% 57 ≤ FiO2 (%) ≤ 63
I/E = ½ and Tplat = 0
VCV Mode
Ventilation parameters Targets
Vt (mL) = 50 40 ≤ Vt (mL) ≤ 60
F(bpm) = 45 44 ≤ F (bpm) ≤ 46
PEEP (cmH2O) = 0 0 ≤ PEEP (cmH2O) ≤ 1.5
FiO2 = 21% 20 ≤ FiO2 (%) ≤ 22
I/E = ½ and Tplat = 0
Flow rate = Cst
PSV Mode
Ventilation parameters Targets
IP (cmH2O) = 25 29 ≤ IP (cmH2O) ≤ 31
F(bpm) = 20 19 ≤ F (bpm) ≤ 21
PEEP (cmH2O) = 5 4 ≤ PEEP (cmH2O) ≤ 6
FiO2 = 30% 28 ≤ FiO2 (%) ≤ 33
VCV Mode
Ventilation parameters Targets
Vt (mL) = 500 450 ≤ Vt (mL) ≤ 550
F(bpm) = 15 14 ≤ F (bpm) ≤ 16
PEEP (cmH2O) = 5 4 ≤ PEEP (cmH2O) ≤ 6
FiO2 = 60% 57 ≤ FiO2 (%) ≤ 63
Trig I = 3 l/min
F max = 17 bpm No Fmax alarm
I/E = ½
Alarm Comments
Switch to VCV mode. Remove the test lung and seal off the
patient circuit.
Check for the switch to expiratory phase when the
High pressure
pressure reaches the alarm threshold, and check that the
‘high pressure’ message appears in yellow during the
first two cycles and then in red during the third cycle.
Verification Comments
Carry out the safety tests for a Class II device see sheet
Electrical safety tests
in Appendix
The machine is calibrated with the machine closed and without the MT60 tool ribbon cable.
Use of the ribbon cable can cause a pressure sensor and O2 cell calibration error.
Close off the patient circuit outlet, and press the ‘Confirm’ button.
Particularly checks:
- The integrity of the sensors to start the tests.
Initialisation of
tests - Zeroing of the sensors not sensitive to oxygen
- Blower tachymetry
Particularly checks:
- Presence of the plug
- Sealing of the insp/exp branches
- Circuit rinsing
Pneumatic checks: - Zeroing of expiratory flow sensor
- 21% of the O2 cell
- Insp and Exp flow sensor
- Micro-blower performance
The symbol appears to specify the environment of use (e.g.: no oxygen is present, etc.).
At the end of testing, check the coherence of the compliance value measured:
1.4 ml/cmH2O (+/- 0.2 mL/cmH2O) for the standard adult double-branch circuit without
water trap (KG020100, batch of 20).
Place a T-fitting at the device outlet and then connect the inspiratory branch
to the expiratory branch of the machine via an airtight hose.
Connect the T-fitting to a 0-100 mbar pressure gauge.
When the bar graph is available on screen, turn the knob to set the actual pressure value
read on the pressure gauge on the MONNAL T60. (Tolerance of ±1mbar).
1) Check that the patient hose does not leak. Repeat the calibration.
Step 1) should usually be sufficient. In the event of corrective maintenance, Step 2) can
help to resolve the situation. If the automatic tests fail, the problem can be diagnosed. If
the tests succeed but calibration fails, call Air Liquide Medical Systems.
This calibration lets you compensate for the effects of altitude on the oxygen cell and flow
sensors.
When the bar graph is available on screen, turn the knob to set the pressure value read on
the reference manometer or, if none, the known local atmospheric pressure, on the
MONNAL T60.
MONNAL T60 accepts a pressure value between 900 and 1200 mbar.
SENSOR OFFSET
1) Purge any residual pressure from the MONNAL T60 by pressing the valve on the
oxygen connector, and then restart the test.
SENSOR GAIN
When the bargraph is visible, connect the machine to an oxygen source (cylinder or wall
network with a pressure gauge or pressure monitoring system).
1) Ensure that the sensor has been zeroed with all O2 sources disconnected (high and
low pressure).
2) Ensure that the sensor gain was done with O2 connected, and that the pressure of
the O2 source is above 2.8 bar.
In the flow calibration procedure, the ventilator will start by delivering what it believes to be
1 L/min (first calibration point).
Use the knob to adjust this flow until the objective flow rate (in this case, 1 L/min) is read
on the external flowmeter.
When the adjustment has been performed, confirm by pressing the knob, and then
proceed to the next calibration point. Repeat this procedure for all the calibration points (1,
2, 3, 4, 5, 10, 20, 30, 50, 70, 90, 110, 130 L/min).
The table below gives the adjustment range for each calibration point:
1) Check that the measuring device is not obstructed (presence of a balloon, etc.), and
check for clogged filters. Repeat the calibration.
Substitute the special YA018100 ‘cap turbine air inlet’ tool for the Monnal Clean’In HEPA
filter to block any possible air intake.
Validate to continue.
Calibration takes place automatically. The previously calibrated patient flow sensor (FS1)
becomes the calibration benchmark sensor. Calibration is then performed internally.
1) Ensure that the oxygen source is properly connected and that the micro-blower air
intake is obstructed. Eliminate any leaks between the rear chassis of the machine
and the blower. Repeat the calibration.
2) Repeat the calibration of the patient flow sensor (FS1) and then relaunch the
automatic calibration of the O2 flow sensor.
All calibrations require the automatic tests to be repeated, as well as an operational check with
the machine closed (refer to the curative maintenance flow chart in Section 8.1).
YR114000 LOUDSPEAKER
12.2. CONSUMABLES
YR049700 O2 CELL
12.3. TOOLS
PART No. REPRESENTATION NAME
Test device
Manufacturer: Type: Serial No.:
Technician who performed the test
Last name, first name: Company:
Result
Step Verification
OK
Device ready to be tested (switched on, lid closed, disconnected from
1
networks)
Visual inspection
2 Check safety-related markings
3 Check integrity of mechanical parts
4 Check for absence of contamination
5 Evaluation of accessories
6 Check presence of documentation
Electrical tests
between 90V and
7 Measure mains voltage: 264V
VPAC Mode
Ventilation parameters Targets value
PI (cmH2O) = 20 18 ≤ IP (cmH2O) ≤ 22 …….
Fmin (bpm) = 10 9≤ F (bpm) ≤ 11 …….
PEEP (cmH2O) = 3 2 ≤ PEEP (cmH2O) ≤ 4 …….
FiO2 = 60% 57 ≤ FiO2 (%) ≤ 63 …….
Child ventilation
VCV Mode
Ventilation parameters Targets value
VT (mL) = 50 40 ≤ VT(mL) ≤ 60 …….
F(bpm) = 45 44 ≤ F (bpm) ≤ 46 …….
PEEP (cmH2O) = 0 0 ≤ PEEP (cmH2O) ≤ 1.5 …….
FiO2 = 21% 20 ≤ FiO2 (%) ≤ 22 …….
PSV Mode
Ventilation parameters Targets value
PI (cmH2O) = 25 24 ≤ IP (cmH2O) ≤ 26.5 …….
Fmin (bpm) = 20 19 ≤ F (bpm) ≤ 21 …….
PEEP (cmH2O) = 5 4 ≤ PEEP (cmH2O) ≤ 6 …….
FiO2 = 30% 28 ≤ FiO2 (%) ≤ 33 …….
10. Check alarms (audible and visual) OK
Patient disconnection
High pressure
PEEP greater than PEEP set-point + 5 cmH2O
FiO2 low and high
11. Absence of self-triggering
12. Switching off the unit OK
Electrical safety tests
Alarm and confirmation request
Date: Technician name:
Measuring instrument: Signature:
C0459