Taema
MONNAL D2
User Manual
code YL001700
Version 2.0 03/99
Taema
Use of oxygen
MONNAL D2
GENERAL SAFETY GUIDELINES
Electromagnetic compatibility
Follow the safety guidelines for the use of oxygen:
• Do not smoke
• Do not use near a source of sparks or incandescent objects
• Do not lubricate working parts.
Use and maintenance of the device
Conformity with NFC 74010 (§6.8.2.b):
"The manufacturer, assembler, installer or importer are not to
be considered responsible themselves for the consequences
on safety, reliability, and characteristics of a device unless:
-The assembly, extensions, modifications or repairs have been
carried out by persons authorised by the party concerned, and
-The electrical installation of the corresponding premises complies with IEC regulations,
-The device is used in accordance with the instructions for use."
If the replacement parts used for the periodic servicing do not
comply with the manufacturer's specifications, the latter is
absolved from all responsibility in the event of an accident.
-Do not open the device whilst in operation.
-Do not use ether-type solvents when washing patients
-Do not use conduits or tubes which are antistatic or conductors
of electricity.
-Do not use in a specifically magnetic environment (MRI, etc.)
The
MONNAL D2
inflammable anaesthetic agents or explosive substances.
pulmonary ventilator must not be used with
MONNAL D2
• The
with the safety requirements of the 93/42/ EEC European
directive.
• The operation of this device may be affected by other devices
being used nearby, such as diathermy and high frequency
electro-surgical equipment, defibrillators, short wave therapy
equipment, mobile telephones and more generally by
electromagnetic interference exceeding the levels specified by
the EN 60601-1-2 standard.
• The
MONNAL D2
the necessary complementary monitoring system (FiO2, flow
measurement, etc.) in compliance with the current
regulations.
It is recommended that a manual ventilation system (of the
Taema
IM5
type) be kept nearby, together with an emergency
medical oxygen tank equipped with a low-pressure reducing
valve.
The
MONNAL D2
with a system for monitoring the pressure in the patient's
airways (of the Taema
Only persons who have read and understood this entire
manual are authorised to use the
The audible alarm of the
to be heard by a practitioner situated close to the patient.
The maximum distance that the user can move away from
it and the volume level of the alarm must therefore be
determined by the user to suit the environment.
ventilator is a medical device complying
ventilator must be used in conjunction with
ventilator must be used in conjunction
PMAX Module
MONNAL D2
type).
MONNAL D2
ventilator is designed
ventilator.
CONTENTS
GENERAL SAFETY GUIDELINES ..................... page 1
CONTENTS ......................................................... page 1
I. INTRODUCTION .............................................. page 2
II. DESCRIPTION AND ADJUSTMENTS ............ page 2
1. Description of front panel .................................. page 2
2. Description of rear panel ................................... page 3
3. Upper cover controls ......................................... page 3
III. USEFUL INFORMATION ............................... page 4
1. Installation ......................................................... page 4
2. Starting up ......................................................... page 4
3. Compressed air flow to
anaesthesia rack ................................................... page 5
4. Ventilation modes ............................................. page 5
6. Alarms ............................................................... page 6
7. Maintenance ..................................................... page 7
8. Maintenance by a technician ............................ page 7
9. Method for disposing of waste .......................... page 7
10. Method for disposing of device ....................... page 7
11. Troubleshooting .............................................. page 8
TECHNICAL DESCRIPTION ............................... page 9
1. Operating Principles .......................................... page 9
2. Technical Characteristics .................................. page 9
V. APPENDICES ............................................... page 10
Symbols - Abbreviations ..................................... page 10
Check-list for start-up / on return
from maintenance ............................................... page 10
5. Safety ................................................................ page 5
Service sheet ...................................................... page 11
1Version 2.0 de 03/99 code YL001700
Taema
MONNAL D2
I. INTRODUCTION
The
MONNAL D2
fulfil the requirements of anaesthetists or resuscitation personnel wishing to use a flexible and multi-purpose ventilator.
- in observation wards and recovery rooms
- in (open circuit) anaesthesia
The
MONNAL D2
or gas mixture (with or without a halogenated agent present).
ventilator is a device specially designed to
ventilator can ventilate a patient with a gas
To provide a complete anaesthetic, it can be supplied with O
and N2O gas from a source of O2 under pressure (or from an
oxygen concentrator) and of N
from the ventilator.
MONNAL D2
The
with:
- a halogenated agent evaporator
- a safety O
- a manual induction circuit
- an anaesthesia table.
ventilator is generally used in conjunction
/ N2O mixer
2
O under pressure, and with air
2
II. DESCRIPTION AND ADJUSTMENT
1. DESCRIPTION OF FRONT PANEL
Description of Items
1 Bacteriological filter cover
2 Collector switch
Controls the working of the expiration valve
3 Flowmeter for ambient air supplied by compressor
4 Airflow regulator
2
5 Insufflation pressure gauge
6 Safety pressure regulator
To adjust, it is necessary to:
• block the patient circuit at Y
• read off the maximum P that appears on the
1
32 4
9
pressure gauge during insufflation
• adjust the regulator by turning towards + or -
Note: The user may keep the maximum P value constant by
removing the detachable button
7 Luminous green On/Off switch
8 Luminous yellow compressor operating switch
When the switch is on the On position, the
MONNAL D2
air. Otherwise only the mixture coming from the
anaesthesia rack is used.
9 Minimum P alarm regulator
Adjustment is by potentiometer.
ventilator delivers compressed ambient
8765
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Taema
MONNAL D2
10
10- Audible maximum P alarm red monitor and stop button
When the luminous and audible alarm is activated,
pressing on the button stops the audible alarm for two
minutes but the flashing red luminous signal continues
to operate.
11- I / E ratio regulator
From 1/3 to 1/1.
12- Frequency regulator
Adjustment of the minimum controlled cycle
1211
frequency from 8 to 40 bpm
13 CV and CAV trigger threshold (TT) regulator
The trigger threshold allows Controlled Assisted
Ventilation. The detection of a call generates a
controlled cycle. If no call is detected, a controlled
cycle is generated by the machine to ensure the
minimum set frequency.
The standard TT settings for CAV are from -1 to -5
mbar. A higher setting requires a respiratory effort
from the patient and generates extra inspiratory effort.
To enter CV mode, set the trigger threshold to
-20 mbar.
1413
14 Inspiratory effort trigger monitor
15 16 17 18 19 20
23
21
21a
2. DESCRIPTION OF REAR PANEL
Description of Items:
15 Timer
Allows scheduling of preventive maintenance
16 Water trap
17 Abacus: air and oxygen mixtures
18 Aeration
19 Mains electricity supply
22
20 Fuses
2 fuses for protection of main supply.
21 Ambient compressed air outlet
Outlet used for setting up of autonomous anaesthesia
22 Fresh gas inlet
23 Manufacturer's name plate
3. UPPER COVER CONTROL
21a Compressed ambient air outlet control switch
Control switch for flow of air from compressor to outlet
(21) used for the setting up of autonomous anaesthesia.
The AIR DIRECT position corresponds to standard
functioning; AIR INDIRECT corresponds to the
autonomous system configuration.
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Taema
MONNAL D2
24 25
III. USEFUL INFORMATION
1. INSTALLATION
1.1. Integrator balloon
Attach the integrator balloon (24) to the side, observing the
following precautions:
• attach the rotating elbow to the side of the device by means
of the ring nut (26) which must be tightened but not locked.
Make sure the seal is in place.
• then slide the latex integrator balloon (24) onto the elbow,
which is free to move in every direction
1.2. Expiratory valve
• Attach the valve support (29).
26
• Place the expiratory valve on its support (with the flow sensor
if necessary)
• Connect the valve balloon to the collector.
29
28 27
Note: The expiratory valve must be inserted in the patient
circuit, at the end of the expiratory branch.
1.3. Bacteriological filter
Check for the presence of the bacteriological filter (27) (white
plastic grille, visible in the cap opening (1)).
• When the filter has to be fitted or replaced, proceed with care
in the following manner:
- Unscrew the cap,
- Change the filter (27),
- Insert it in the housing (28) attached to the device (it can only
be placed in one position),
- Replace the cap firmly,
- Screw it in.
Note: The cap must be correctly engaged. It should screw in
freely and without effort (if not, the cap is badly positioned).
- when you are sure that the cap has been correctly installed,
airtightness is achieved by tightening firmly but not excessively.
2. STARTING UP
1
• Check that the voltage of the power outlet used is the same as
the voltage of the device as indicated on the rear panel. Then
21bis
21
connect the device to the electricity supply.
To start the device, press the On/Off button, which will stay
pressed down: the integrator balloon will inflate and deflate
alternately.
To stop the device, press the On/Off button, which will return to
the Off position.
4 Version 2.0 de 03/99 code YL001700
• Check that there is no leakage. If necessary:
- tighten the integrator balloon elbow,
- tighten the cap.
Taema
MONNAL D2
3. COMPRESSED AIR FLOW TOWARDS THE
ANAESTHESIA RACK
AIR INDIRECT
AIR DIRECT
Label and Switch for air flow (21A)
standard position
AIR INDIRECT
AIR DIRECT
Label and Switch for air flow (21A)
autonomous position
• The
MONNAL D2
autonomous air generator.
In standard configuration, AIR DIRECT position, the air whose
rate of flow is read on the flowmeter (3) supplies the patient
circuit directly.
Bypass is achieved by turning the control switch (21A) to AIR
INDIRECT. This is used via the outlet (21) on the rear panel.
ventilator's compressor can be used as an
Note. The control switch (21A) must not be placed in an
intermediate position. Only positions AIR DIRECT and AIR
INDRECT are operational.
• Flow start-up
4. VENTILATION MODES
The
MONNAL D2
(potentiometer 13) which allows it to ventilate in controlled
mode or in assisted controlled mode.
4.1. Controlled Ventilation CV
The characteristics of the respiratory cycle are entirely
determined by the ventilator, without the patient being able to
intervene.
ventilator has a trigger threshold regulator
13
This mode is recommended in the following situations:
- during anaesthesia
- in all cases of additional ventilation
- for the great majority of the usual indications for artificial
respiration
However, the lack of adaptability of this mode gives rise to
discomfort, i.e. coughing or resistance.
4.2. Controlled Assisted Ventilation
The patient sets off respiratory cycles which are controlled by
the ventilator. Only the frequency is determined by the patient;
the ventilator ensures a minimum frequency.
This mode is recommended when ventilation requirements are
variable when patient is conscious or in resuscitation and
controlled ventilation with or without PEEP does not allow
satisfactory adaptation to the respirator.
5. SAFETY AND PROTECTION
5.1. Safety devices and electrical protection
• Fuses protecting the general supply (2 fuses) (on rear panel
(20)).
• Internal fuse to protect 100 mAT electronic board.
• Thermal circuit breaker of compressor:
Triggered when the compressor temperature reaches 135ºC.
In this way excessive overheating of the compressor is avoided.
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Taema
MONNAL D2
5.2. Safety devices and pneumatic protection
• Safety valve:
Limits the pressure in the patient circuit to a pressure adjustable
to 80 mbar.
• Integrator balloon protection valve:
This valve is situated inside the device and limits pressure to 90
mbar.
• Aeration of the device:
An internal fan ventilates the case and the compressor.
• Gas filtration:
This is carried out by a bacteriological filter between the device
and the patient.
6. ALARMS
6.1. Electricity supply fault
A - example: Pmini sounds
pressure
Pmini
times
B - example: Pmini sounds
pressure
Pmini
times
C - example: Pmini does not sound
pressure
Pmini
times
In the case of a power cut while the
operation, a continuous audible alarm is triggered (minimum time
5 minutes).
Note : This alarm may also be triggered if there is a fault in
supply to the electronic part.
6.2. P minimum alarm
An audible and luminous alarm is triggered in the following
0
0
situations:
- If, for more than 10 seconds, the pressure in the patient circuit
does not achieve the set value (adjustable from 0 to 60 mbar)
(see diagrams A and B opposite);
- If, in "CONTROL" mode, the minimum P is set at 0 mbar. To
avoid triggering the alarm in this way, set P minimum at a few
mbar.
This alarm can be suppressed for two minutes by pressing on
the sound inhibition button.
MONNAL D2
ventilator is in
7. MAINTENANCE
7.1. Cleaning / Disinfection
Wash the entire patient circuit by immersion in a cleaning
solution such as Surfanios (trade mark). Rinse in hot water and
dry. It can be disinfected / decontaminated with a solution such
0
as Hexanios G+R (trade mark).
Clean or replace the patient circuit for each new patient and
whenever necessary (damaged or soiled circuit, etc).
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The respirator can be washed in soapy water by means of a
cloth (well wrung out) dipped in soapy water and wiped with a
dry rag or a towelette impregnated with an aqueous alcoholbased solution.
Taema
MONNAL D2
28 27
7.2. Continuous sterilisation
The bacteriological filter at the device outlet allows sterilisation
to be limited to the patient circuit only. Change the
bacteriological filter every 600 hours.
• Sterilisation in an autoclave: the autoclavable patient circuit in
the Taema catalogue is compatible with the following AFNOR
cycles:
. 134ºC, 18 minutes (cf prions)
. 121ºC, 30 minutes.
Recommended frequency of sterilisation in autoclave: after
each patient or after each cleaning / disinfection cycle.
1
The patient circuit is also sterilisable by all normal procedures
(gaseous formaldehyde etc).
Note: Do not use abrasive powders, pure alcohol, acetone,
or other powerful solvents.
8. MAINTENANCE BY A TECHNICIAN
• Every 1500 hours or annually
- replace filter compressors, collector block membranes.
- check pressure gauge, drive pressure, cocks and valves
• Every 5000 hours
- replace integrator balloon
• Every 10,000 hours or every 5 years:
- return device to factory for complete service (see
maintenance manual to carry out these operations).
9. ACCESSORIES
The accessories used with the
be:
• oxygen compatible
• biocompatible
• compliant with the general requirements of EN 60 601-1
and directive 93/42/EEC.
They must also be non-antistatic (or not conductive of
electricity).
The use of accessories not compliant with the requirements set
out above discharges the manufacturer of responsibility in case
of accident.
Accessories manufactured by Taema or included in the
accessories package supplied with the device are compliant
with these requirements.
Electro-medical devices linked to, or used jointly with the
MONNAL D2
with the essential requirements of directive 93/94/EEC.
ventilator must not interfere with it, in compliance
MONNAL D2
ventilator must
10. METHOD FOR DISPOSING OF WASTE
All waste arising from the use of the
(patient circuit, filters, etc) must be disposed of by the appropriate
channels in the healthcare establishment.
MONNAL D2
ventilator
11. METHOD FOR DISPOSING OF THE DEVICE
In order to protect the environment, if the device is disposed of,
it must be done through the proper channels of the healthcare
establishment.
Furthermore, the traceability system required by labelling
makes it mandatory to inform the TAEMA technical department
of the serial number of the device disposed of.
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Taema
MONNAL D2
11. TROUBLESHOOTING
Observations
No Ventilation
-Compressor does not work and the clock
does not function
Compressor does not work and clock does
not function
On/Off button is in On position
'Power fault' alarm on
Compressor does not work, but the clock
functions
Compressor works, clock functions and Pmini
alarm sounding
Compressor works, but clock does not
function
Ventilation still insufficient
Causes probables
- On/Off button not pressed
-No electrical power
- Device supply fuse(s) out of order
-100 mAT fuse out of order
- Compressor overheating
(thermal circuit breaker cut in)
-Ventilation button off
(flowmeter indicating 0)
- Defective pneumatic circuit
- Control 21A in wrong position
- Defective electronic unit
- Patient circuit not airtight or defective
- Filter assembly badly fitted, not airtight
Remède
- Press the On/Off button
- Check electrical power connection
- Change the main supply fuse(s)
- Change the 100 mAT fuse
- Check air intakes
- Contact after-sales service
- Open ventilation valve
- Contact after-sales service
- Check by-pass control (21A)
- Contact after-sales service
- Check connection: The expiratory
valve membrane inflates and deflates
alternately
- Remove and reinstall the assembly
with care
Controlled Assisted Ventilation (CAV)
breakdown
"TRIGGER" LED permanently flashing
"Trigger" LED does not light up
Pmini
Pmini alarm activated continuously
Pmini alarm does not trigger
- Self-activated
- Defective electronics
- Trigger threshold set at about - 20 mbar
- Wrongly adjusted
- Defective electronics
- Adjust the trigger threshold correctly
- Contact after-sales service
- Correct the trigger threshold setting
- Adjust the Pmini threshold correctly
- Contact (TAEMA) after-sales
service
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Taema
MONNAL D2
IV. TECHNICAL DESCRIPTION
1. OPERATING PRINCIPLES
The collector / electronically controlled valve is supplied:
• with air through a compressor
and / or
• with a mixture of anaesthetic gas or with pure oxygen.
Air ventilation is displayed on a flowmeter and controlled by a valve.
The collector block comprising diaphragms linked to electronically controlled valves, controlled by the electronic unit, distributes
the continuous flow:
- on one hand, towards the integrator balloon during the expiratory phase,
- on the other, added to the gas stored by the balloon, towards the patient through a bacteriological filter during the inspiratory
phase.
The insufflation pressure is visually represented on a pressure meter and can be limited by adjusting a safety valve.
The electronic unit allows adjustment of frequency, the I / E ratio, the SD activation threshold (in VAC mode) and the Pmini
threshold. It also provides visual indication of the SD activation threshold, an audible and visual indication of Pmini, audible
indication of electric power failure.
2. TECHNICAL CHARACTERISTICS
• Power supply: 220 V - 50 Hz
- Power consumption: 160 VA
- Class I device
- Class B device
• Maximum current protection:
- Mains supply protection: 2 F1A fuses (rear panel)
- Electronic card protection: 1 internal 100 mAT fuse
• Protection against lack of power:
- Audible alarm (discharge time: 10 minutes)
• Dimensions: L x B x H = 470 x 308 x 150 mm
• Mass: 14 kg.
• Extreme storage temperatures: from -40°C to +70°C
• Extreme operation temperatures: from +10°C to +40°C
• Atmospheric pressure (use): from 700 to 1060 mbars
• Relative humidity (use and storage): from 30 to 75%
• Degree of protection: IP20 (protected against solid bodies
greater than 12 mm and not protected against liquids).
• Performance:
- Respiratory frequency: from 8 to 40 bpm
- I / E ratio: from 1/1 to 1/3
- Mean flow (insufflated per minute): from 0 to
20 l / min
- Pmini pressure threshold: from 0 to 60 hPa
- Activation threshold (VAC): from 0 to -20 hPa.
• Instantaneous pressure display: from -20 to 100 hPA
• Materials in contact with the patient and the breathed gases:
Silicon (autoclavable patient circuit), Latex (accumulator
balloon), PVC, and aluminium.
• Standards / Directives:
NFC 74350 - Artificial respiration and treatment devices
NFS 90-118 Ventilators for medical use
NFEN 601 - 1 Safety of electro-medical devices
NFEN 60-601-1-2 Electromagnetic compatibility of medical
devices.
OPERATION BLOCK DIAGRAM
l/min
20
0
V
¯
Compressor
¬
¬
0/1
compr.
®
¯
Anaesthetic
Mix
or O
2
®
mbar
¬
100
- 20
pressure
Commutator
block
Solenoid
valves
Integrator
balloon
Safety valve
¬
Electronic Unit
®
f, I / E,
Pmini,
¬
SD
settings
Pmini, power
®
alarms
¯
¯
Bacteriological
¯
filter
¯
Commutator
Patient
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Taema
MONNAL D2
V. ANNEXE
SYMBOLS AND ABBREVIATIONS
: Off (power off)
I : On (power on)
: Suspension of audible Pmini alarm
I/E : Inspiration / Expiration phase ratio
f : Frequency
SD/Trigger : Trigger threshold
: Earth protection
: Equipotential
: Refer to accompanying documents
: Type B device
0459: Compliance with directive 93 / 42 EEC
(established by notified organisation no. 0459)
CHECK-LIST FOR START-UP / ON RETURN FROM MAINTENANCE
Before each use and after every return from maintenance, carry out the sequence below:
• Set the On/Off switch to Off
• Check that the voltage of the electric plug used corresponds to the voltage of the device. Then
plug the device in.
• Start the compressor by pressing the On/Off button (7) situated on the front panel. Make sure
the button lights up (colour yellow).
• Start the ventilator by pressing on the On/Off button situated on the front panel. Make sure the
button lights up (colour green).
• Check that the Pmini audible and luminous alarm (flashing red) is activated through a few cycles
(in the time for the balloon to inflate).
• Check that the humidifier (if used) is correctly filled and that the heating temperature complies
with the prescription.
• Check that the integrator balloon is in good condition (no leakage etc).
• Fit a clean patient circuit, having checked beforehand that it is in good condition.
• Adjust the settings according to the prescription and check that the values displayed correspond
to the settings.
• Adjust the Pmax safety valve. Then block the patient circuit at the Y piece (with the thumb, for
example) and check that the pressure limitation in the patient circuit is functioning correctly.
• Connect the patient to the ventilator. Check that the integrator balloon inflates and deflates
correctly.
• Check that the appropriate monitoring (flow measurement, FiO2, airways pressure, halogen etc)
is operational.
• Check that the machine is generally functioning properly.
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Taema
MONNAL D2
VI. APPENDIX
2 500 Hours 5 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
7 500 Hours 10 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
12 500 Hours 15 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
17 500 Hours 20 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
MAINTENANCE SHEET
MONNAL D2 VENTILATOR
Commissioned on: ...........................................
Maintenance provided by: ...............................
...........................................................................
Your distributor: ...............................................
Address: ............................................................
...........................................................................
...........................................................................
Telephone: ........................................................
Preventive maintenance of the devices must be carried out
keeping to the manufacturer's directions set out in the
maintenance manual and any updates thereof.
The work must be carried out by technicians who have
received the appropriate training.
Only use original components.
On request, the supplier provides circuit diagrams, lists of
components, technical descriptions and all other information useful to personnel qualified to repair those parts of the
device which have been designated as repairable by the
manufacturer.
no: .......................
Taema
22 500 Hours 25 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
27 500 Hours 30 000 Hours
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
Carried out on: .............................
No. of hours: ................................
Name of technician : ....................
......................................................
Signature
and
stamp:
AIR LIQUIDE Santé: AIR LIQUIDE. One mission, one ethic, one
ambition. In more than 40 countries the mission of AIR LIQUIDE
Healthcare's staff is to contribute to the improvement of care given to
patients, at hospital and at home. Their ethic is the constant attention
given to patients and to stand side by side with those who care for them.
Their ambition is to promote the development of the AIR LIQUIDE
Taema is a division of AIR LIQUIDE
Group in the healthcare profession
Santé
INTERNATIONAL
Taema
Parc de Haute Technologie
6 rue Georges Besse CE 80
92182 Antony CEDEX - FRANCE
Tel.: (33) 01 40 96 66 00
Fax: (33) 01 40 96 67 00
11Version 2.0 de 03/99 code YL001700
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