Professional Documents
Culture Documents
Prohibition of disassembly
Manufacturer
Manual number
2
Warning
● The condition of the patient using this device should be properly monitored by the
medical staff by using an appropriate monitoring device. Since this device does not have
a biological information monitor function, use another biological information monitor
such as a pulse oximeter or a vital- signs monitor to prevent medical accidents.
● Always have immediate access to an alternative means of ventilation, which is ready for
use, in order to reduce the possibility of patient death or serious deterioration of health.
● Do not add any attachments or accessories to the ventilator that contravene the
instructions for use of the ventilator or accessory, as the ventilator might not function
correctly, leading to the risk of patient death or serious deterioration of health.
● Adding attachments or other components or sub-assemblies to the ventilator breathing
system can change the pressure gradient across the ventilator breathing system. These
changes to the ventilator breathing system can adversely affect the ventilator’s
performance.
● The ventilator shall not be covered or positioned in such a way that the operation or
performance of the ventilator is adversely affected, for example: Do not position next to
a curtain that blocks the scavenging connection to the scavenging system.
● Make sure to check that there is no blockage or leak before connecting the breathing
circuit (including tracheostomy tubes and other products worn by the patient).
● When using this device, be sure to use HMEF together to prevent nosocomial infections.
● When using nebulization, breathing system filters and heat and moisture exchangers can
require more frequent replacement to prevent increased resistance and blockage.
● This device does not fully comply to the IEC 60601-1-8 alarm standard, so please use it
in a state where you can monitor the patient by using the alarm function of the vital
signs information monitor device used together.
● This device does not have a battery for driving during a power failure, so please plug it
directly into a grounded outlet such as an Uninterruptible Power Supply (UPS). If it is
used with a general commercial power source, the operation of this device will stop
during a power failure and seriously affect the patient.
● This device uses oxygen. Please keep fire away while driving. Danger of explosion or fire.
● Never use in a flammable anesthetic gas and high oxygen concentration environment.
Danger of explosion or fire.
● If an abnormality occurs in this device, take prompt action to handle the patient by
mechanical respiratory support.
● The ventilator shall not be used in a hyperbaric chamber. Such use might cause the
ventilator to not function correctly, causing patient death or serious deterioration of
health.
● The ventilator shall not be used with nitric oxide. Such use might cause the ventilator to
not function correctly, causing patient death or serious deterioration of health.
● The ventilator shall not be used with inlet gases, which are not specified for use (e.g.
helium or mixtures with helium). Such use might cause the ventilator to not function
correctly, causing patient death or serious deterioration of health.
● Before using this device on a patient, be sure to check that it operates normally with
normal ventilation before using it. Use a rest lung for this purpose.
● Only specialized personal are allowed to disassemble the main body or any other
components of this device.
● The operator should always be available to hear the audio alarm. Set alarm parameters
appropriately. Alarms are very important to show any risk for the patient.
● When using a defibrillator, be sure that neither the patient body nor any metallic part
connected to the patient gets in touch with defibrillator.
● Do not use auto-clave, ETO, or the other sterilization types to clean the ventilator main unit.
● When using ethylene oxide gas (ETO) for component sterilization, make sure to ventilate with
room air until the concentration becomes safe.
● With Eliciae MV20, disassemble the flow sensor cable for cleaning. Do not sterilize.
● For each use per patient, following components are required to sterilized: jet assy and
exhaust gas connector.
● Single-use items are include HMEF, circuit set, and proximal flow sensor. Dispose them
after use.
3
Prohibited
● Never leave the patient alone while the alarm is muted.
● To avoid the risk of fire due to an increase in oxygen concentration, do not use this device
in a hyperbaric treatment room.
● Do not use this device in an MRI examination room.
● Do not use with radiation therapy equipment.
● Do not use this device in a high temperature environment exceeding 40℃. This may cause
the equipment to malfunction or stop ventilation.
● Do not place liquid such as infusion bottle near this device. If liquid enters the device, it
may cause damage and may cause electric shock to the patient.
● Do not connect anything other than specified to the terminals of this device. Also, do not
insert metal fittings into the terminals or touch them with your hands. Not only can this
unit be damaged, but it can also cause electric shock.
● Do not install this device in the vicinity of devices or equipment that generate
electromagnetic waves, such as personal computers, communication equipment, mobile
phones, and elevators. It may cause the malfunction of this device.
● In order to prevent damage to this device, do not block the exhaust port of the main unit.
Caution
When installing the equipment, note the following:
● Install it in a place where it will not get wet.
● Install in a location where there is no risk of adverse effects from air that contains
extreme temperature, humidity, ventilation, ultraviolet rays, dust, salt, or sulfur.
● Caution in a stable state such as inclination, vibration, impact (including during
transportation).
● Install the product away from chemical storage and gas generation sites.
● Caution the power supply voltage and frequency and allowable current value (or power
consumption) before installation.
● Be sure to install the power supply with the ground properly connected to the medical
grade outlet.
4
Caution
After using the device, please note the following:
● Return the operating switches, dials, etc. to the state before use by the specified
procedure, and then turn off the gas source.
● Disconnect the O2 and air pressure hoses during storage or when not using the ventilator
for a long period. Even in the power OFF mode, gas will be consumed by the breathing
circuit monitor line and other pressure accessories and there is a possibility for this
pressure to reduce the components life time.
● Clean used instruments so that they will not interfere with the next use.
● Please note the following about the storage location.
· Store in a place where it will not get wet.
· Store in a place where there is no possibility of adverse effects due to temperature,
humidity, ventilation, sunlight, dust, air containing salt, sulfur, etc.
· Caution should be performed in a safe condition such as tilt, vibration, shock (including
transportation).
· Do not store in a place where chemicals are stored or where gas is generated. Clean up
accessories and piping tubes, etc., and then keep them organized.
● Be sure to keep the equipment clean so that it will not interfere with the next use.
5
Table of content
FOR SAFE USE........................................................................................................................ 2
INTRODUCTION ................................................................................................................. 2
PRECAUTIONS FOR USE ....................................................................................................... 2
BUNDLED ITEMS.................................................................................................................... 8
BASIC SET TYPE ................................................................................................................ 8
FULL SYSTEM TYPE ............................................................................................................. 9
CONNECTION DIAGRAM...................................................................................................... 15
CONNECTION EXAMPLE FOR ELICIAE MV20 AIR DRIVE ............................................................... 15
6
USE OF THIS DEVICE ........................................................................................................... 46
TYPES OF MODES............................................................................................................. 46
MONITOR MODE .............................................................................................................. 46
BACKUP VENTILATION MODE ............................................................................................... 47
MANDATORY VENTILATION MODE ......................................................................................... 48
OTHERS ............................................................................................................................... 71
ABOUT STORAGE ............................................................................................................. 71
ABOUT TRANSPORTATION .................................................................................................. 71
ABOUT DISPOSAL............................................................................................................. 71
INFORMATION .................................................................................................................... 74
RESPONSIBILITY FOR THE PATIENT SAFETY ............................................................................. 74
WARRANTY .................................................................................................................... 74
EXCLUSIONS................................................................................................................... 74
EXCLUSIVE REMEDY ......................................................................................................... 75
DISCLAIMERS ................................................................................................................. 75
GLOSSARY ..................................................................................................................... 75
7
Bundled items
Basic set type
Including;
Air-oxygen conversion plug 1
Exhaust tube
Accessory
Y-type pressure gas tube (air)
HMEF (disposable)
3 ~ 6*
Blender
AC power code
1
*The number of members may vary depending on the country. Please contact your
distributor for details.
8
Full system type
Name Photo Qty
Main unit
Including;
Air-oxygen conversion plug 1
USB cap
Exhaust tube
Accessory
Name Photo Qty Name Photo Qty
Y-type Blender
pressure gas
tube (air) 1
1
Pressure gas
line (oxygen) Cart
1
0 ~ 1*
Breathing
circuit set
(disposable)
Including; Support arm
Adjustable safety
1 ~ 2*
valve Y-piece
connector
Pressure monitor 0 ~ 1*
tube
Fresh gas tube
Tube clip
Flow sensor
(disposable) 1 ~ 2* Scavenger
system
Flow sensor
cable
1 Including; 0 ~ 1*
Vacuum tube
300mm
HMEF Vacuum tube
5,000mm with
(disposable) connector
3 ~ 6* Test Lung
0 ~ 1*
AC power code
1
*The number of members may vary depending on the country. Please contact your
distributor for details.
9
Name and function of each part
Front of main unit
7 6 5 4
3 11
2
12
1
13
10
10
Front main unit (Cont)
19 20
14
23 15
16
17
18
21 22 24
11
Main unit rear view
2 6
4
7
Use only medical oxygen and air. Other types of gases not only affect the
Warning
operation of this equipment, but they can also explode and corrode.
● This device uses high pressure gas. Please check that there are no loose
connections. Any loose connections may cause an explosion or fire due to
gas leakage. If there is a gas leak, stop use immediately.
Caution ● If the device is stored and not used for a long time, remove the pressure
tube from the gas supply source. Even if the power switch is "○" OFF or
the mode selector knob is "OFF", if it is connected to the gas supply source,
high pressure may be constantly applied to the pressure regulation
component, which may shorten the component life.
12
Accessories
● Install the breathing circuit, tube, and power cord so that they do not interfere
with the operator while using the equipment. There is a risk of dropping the
Warning device if it gets caught in the cord or circuits.
● Be sure to use HMEF together with this device to prevent nosocomial infections.
● When pulling out a circuit, tube, or cord, do not pull it out without holding its
Prohibited root. Forcibly pulling out may result in disconnection or damage.
13
Options
□
J Cart
□
K Support arm
Equipment combination
The devices to be combined are not included with the main unit. Please use approved
combination products owned by the facility. Also, please read the instruction manual
and attached documents that come with the device to be used carefully before use.
● Since this device does not conform to the IEC 60601-1-8 alarm standard, please
use it in a condition that can monitor the patient, such as using the alarm function
Warning
of the biological information monitor device together.
14
Connection diagram
Connection example for Eliciae MV20 air drive
All pictures or illustrations in these IFU are for reference purpose. The actual objects might be slightly different.
□
L □e Scavenger duct The patient's exhaled air is temporarily stored and discharged.
□
f Vacuum tube 300mm Connect the exhaust port adapter of the main unit and the scavenger.
□
g Vacuum tube 5,000mm A 22mm tube to connect to the scavenger system to hospital vacuum system.
Since the device does not fully complies to the IEC 60601-1-8 alarm
□
M Vital signs monitor standard, make sure to use combined with a vital-signs monitor with
alarm functions.
15
About this device
Intended use
The Eliciae MV20/Compos MV20 Ventilator is indicated for the continuous or
intermittent invasive mechanical ventilatory support of patients weighing at least 30
kg who require mechanical ventilation. The ventilator is a restricted medical device
intended for use by qualified, trained personnel under the direction of a physician.
Specifically, the ventilator is applicable for patients >30 kg who require f ventilatory
support, as prescribed by an attending physician:
· Positive Pressure ventilation
· Time-cycled, pressure limited ventilation
· (A)CMV mode of ventilation.
· Pressure assist control ventilation with open exhalation valve
· Supports breathing types including Pressure Control and non-assisting
Monitoring Mode
The ventilator is suitable for use in institutional settings. It is not intended for use as
an intra-hospital or emergency transport ventilator. Additionally, the power supply
needs to be monitored as there is a loss of power alarm but no backup power supply
to provide ventilation.
Place to use
The ventilator is suitable for use in institutional settings. It is not intended for use as
an intra-hospital or emergency transport ventilator.
Target patients
Patients weighing at least 30kg who require mechanical ventilation.
Authorized users
The ventilator is a restricted medical device intended for use by qualified, trained
personnel under the direction of a physician.
Others
When using this device as indicated in About storage, it is necessary to leave it for
about 30 minutes at an environmental temperature of 20℃ until it is ready to use.
Condensation may occur if the device is taken out from a cold storage state to room
temperature. Wait 30 minutes or more at room temperature before using it as it may
cause a malfunction.
16
Preparations before use
Installation
Install this device on a stable and level surface.
When using the optional cart, read the instruction manual for the cart carefully
before use.
17
Blender installation
※ Please refer when using the attached blender.
※ See Blender removal.
[1] Insert the attached blender firmly into the blender holder on the side of this
machine until it touches the bottom of the holder.
Blender
Blender holder
[2] Choose the transparent and thick (Φ10mm) fresh gas tube from the three
tubes in the attached breathing circuit set.
Breathing tube
Thick (Φ10mm)
fresh gas tube
Pressure monitor tube
thin tube
[3] Firmly push the fresh gas tube onto the blender connection terminal up to the
3rd stage.
Blender connection
18
Power cord connection
※See Disconnecting power and removing the power cord.
[1] Check that the power switch on the back of this device is turned off “○”.
[2] Lift the lock lever upward and insert the attached power cord into the inlet
terminal as far as it will go.
Lock lever
Inlet terminal
[3] Lower the lock lever and lock it firmly so that the power cord cannot be pulled out.
● Be sure to use the power cord with a 3-pin plug that comes with this device.
There is a risk of electric shock to the patient and operator if other power
Warning cords are used.
● Do not connect anything other than the supplied power cord to the inlet
terminal of this device.
● Do not insert metal fittings into the terminals inside the inlet or touch
Prohibited them directly with your hands. It may cause a device failure or electric
shock.
Do not modify the power cord without permission. There is a risk of electric
shock to the patient or operator.
19
Connection of pressure tube (oxygen)
※ The attached pressure gas tube varies depending on the region. Please contact
your distributor for details.
※ Refer to Removal of driving gas (oxygen).
[1] Make sure the valves are closed by turning the oxygen (O2) and air (AIR) knobs
on the blender clockwise.
O2 knob
AIR knob
[2] Insert the pressure gas tube (oxygen) into the air connection port on the back of
the blender, and use a tool such as a spanner to tighten the nut securely.
Nut
[3] Insert the other end of the pressure gas tube (oxygen) into the gas supply
terminal until it clicks into place.
Caution This device uses high pressure gas. Please note any loose connections. If it
is loose, there is a risk of explosion or fire due to gas leaks.
20
Driving gas connection (air)
※ The attached pressure gas tube varies depending on the region. Please contact
your distributor for details.
※ When using the attached blender, use Y-type pressure gas tube (air).
※ Refer to Removal of driving gas (air).
[1] Insert the attached Y-type pressure gas tube (air) into the “GAS INLET” on the
back of the ventilator main unit, and tighten the nut securely using a tool such as
a spanner.
Nut
[2] Insert the remaining Y-type pressure gas tube (air) into the air connection port
on the back of the attached blender, and tighten the nut securely using a tool
such as a spanner.
Nut
[3] Insert the other end of the Y-type pressure gas tube (air) into the gas supply
terminal until it clicks into place.
The pressure of the gas supply source must be 3.0-4.5 kgf/cm2.
Use only medical air. Other types of gas not only affect the operation of
Warning this equipment, but also risk of corrosion and explosion.
21
Breathing circuit connection
※ Refer to Breathing circuit removal.
[1] Push the breathing tube of the attached breathing circuit set onto the “OUTLET”
terminal on the front of this device, and push until firmly in place.
Breathing tube
[2] Push the transparent thin (6mm) pressure monitor tube of the attached
breathing circuit set onto the “PAW MONITOR” terminal on the front of the
ventilator main unit, and push until firmly in place.
The outlet terminal on the front of the main unit is a B-rated attachment part.
22
Setting flow sensor and sensor cable
※Refer to Removing flow sensor and sensor cable from the main unit.
[1] Hold the flow sensor and sensor mounting part of the sensor cable as shown.
Insert the notch of the flow sensor into the red arrow mark on the sensor
mounting part.
Sensor cable
Mounting part
Flow sensor
[2] Make sure that the red circled tabs in the figure click into place and the flow
sensor does not come off.
23
Connecting the sensor cable
※ Refer to Disconnecting the sensor cable from the main unit.
[1] Hold the plug body with the "→" mark on the plug part of the attached sensor
cable facing up.
「→」 mark
Sensor cable plug
[2] With the "→" mark on the plug still facing up, insert it into the “PROX. FLOW
SENSOR” terminal on the front of the device until you hear a click.
Do not insert while holding the cable part of the sensor cable. It may
Prohibited break the cable.
● The connector can only be inserted in a specific position. Be careful of
the direction and make sure that the "→" mark is on top.
Caution ● Be sure to make sure that you hear a clicking sound when inserting the
connector. Incomplete insertion will cause the patient's breathing to be
improperly monitored.
24
Connecting the flow sensor to the breathing circuit set
※ Refer to Disconnecting the flow sensor to the breathing circuit set.
[1] Hold the breathing circuit set and the flow sensor as shown.
The connector with the 「→」 mark on the flow sensor fits into the Y piece.
Then, firmly insert the Y-piece connector and the flow sensor into each other.
「→」 mark
Flow sensor
Y-piece connector
[3] Secure the flow sensor cable to the clips on the breathing tube so that it will not
get caught during operation.
Do not insert while holding the cable part of the sensor cable. It may
Prohibited break the cable.
25
Connection of HMEF
※ Refer to Removal of HMEF.
HMEF
Flow sensor
[3] When securing the breathing circuit set using the optional support arm, hold the
flow sensor with the sensor probe part facing upwards.
If the sensor detector condenses due to the exhalation of the patient, the
measurement cannot be performed correctly.
Be sure to use HMEF. If HMEF is not used, nosocomial infection of new type
pneumonia may occur.
Warning When using your existing HMEF, please read the attached instruction
manual carefully.
Do not hold the breathing tube part of the attached breathing circuit set and
insert it.
Prohibited It may cause damage to the breathing circuit tube.
● Please note to make sure that the connection does not have leaks.
Caution ● Use with the sensor detection part facing up.
26
Optional scavenger system installation
For details, please read the instruction manual attached to the scavenger system
carefully.
[1] Secure the scavenger duct to the optional cart according to the instruction
manual attached to the scavenger system.
[2] Push the vacuum tube 300mm attached to the optional scavenger system firmly
over the exhaust port adapter connected to the exhaust port on the back of the
main unit.
[3] Push the vacuum tube 300mm firmly over the 22mm connector on the scavenger
duct.
[4] Firmly insert the 5,000mm vacuum tube included with the scavenger system into
the 19mm terminal of the scavenger duct.
[5] The other end of the 5,000 mm vacuum tube should be connected to a suction
system.
Caution Please ensure that the connection does not have leaks.
27
Connection to power supply
※ Refer to Disconnecting power and removing the power cord.
Insert the AC plug of the power cord firmly into the grounded outlet (green) of the
UPS or the uninterruptible power supply such as UPS, as far as it will go.
28
Alarms check
Alarms type and description
This device has the alarms listed in the table below.
Alarm type Alarm description
High pressure alarm It is an alarm that occurs when the airway pressure high,
(Paw high) exceeding 120% of the PIP set value.
The alarm buzzer sounds intermittently and the Paw High
alarm LED flashes. Ventilation stops when the airway
pressure goes above the high-pressure alarm range.
Low pressure alarm It is an alarm that occurs when the airway pressure is lower
(Paw low) than 80% of the PIP set value.
The alarm buzzer sounds intermittently and the Paw Low
alarm LED flashes.
Low gas supply alarm It is an alarm that occurs when the airway pressure is lower
than 80% of PIP set value.
The alarm buzzer sounds intermittently and the Low Gas
Supply alarm LED flashes.
Power failure alarm This alarm occurs when there is a power failure while the
device is operating.
When the power switch on the back of this device is turned
on and the mode switch on the front of this device is set to
a state other than "OFF", when the power cord is
unplugged from the power outlet, the alarm buzzer for
power failure sounds and the power turns on. Check that
the LED for the abnormal alarm is lit.
APNEA alarm This alarm is activated when the patient exceeds APNEA set
value.
When the set APNEA time is exceeded, the alarm buzzer
sounds intermittently and the APNEA alarm LED flashes. A
full-pressure-controlled breath will be delivered by the
device when the apnea alarm is activated.
Flow sensor alarm An alarm will occur if the flow sensor cable is not connected
securely.
If an abnormality occurs in the flow sensor while using this
device, the alarm buzzer sounds with an intermittent tone and “---
-” flashes in the tidal volume display area.
High tidal volume alarm An alarm is activated when the patient VT exceeds 125% of
initial VT value at the time of ventilation setting.
The alarm buzzer sounds intermittently and the tidal volume
display LED flashes between “Hi - - “ and “Tidal volume
value”.
Low tidal volume alarm An alarm that will be activated when the patient tidal
volume becomes lower than 75% of initial tidal volume
value at the time of ventilation setting.
The alarm buzzer sounds intermittently and the tidal volume
display LED flashes between “Lo - -“ and “Tidal volume
value”.
High breath rate alarm An alarm that will be activated when the patient breath rate
exceeds 200% of breath rate set value.
The alarm buzzer sounds intermittently and the breath rate
display LED flashes between “Hi-“and “Breath rate value”.
29
Alarm operation check before using the device
[1] Connect the test lung as shown in the picture to the end of the HMEF. The test
lung does not be bundled depending on the country. Please contact your
distributor for details.
[2] Set the PIP, PEEP, Breath rate, Inspiratory time, and APNEA as follows by
operating the device settings, and operate this device in Mandatory ventilation
mode.
Item Set value
PIP 30cmH2O
PEEP 5cmH2O
Breath rate 20 BPM
Inspiratory time 1.0sec
APNEA 10sec
[3] Check the operation of each alarm according to the procedure in the table below;
1. Turn the power switch on the back of the device to “l” ON.
2. Turn the mode switching knob on the front of this device to the mandatory
ventilation mode.
3. The ventilation operation starts.
30
Alarm type How to confirm alarm issuance
Low gas 4. Remove the breathing tube from OUTLET.
supply alarm 5. At this time, check that the Low gas supply alarm
LED flashes and the buzzer sounds intermittently.
* At the same time, the Paw low alarm is activated.
6. Connect the Breathing tube to OUTLET.
7. After a while, check that the Low gas supply
alarm LED goes off and the buzzer stops
sounding.
Power failure 4. Unplug the AC plug of the power cord from the
alarm wall outlet.
5. Confirm that the power failure alarm LED is lit
and a continuous buzzer sounds.
6. Point the AC plug to the wall outlet and check
that the power failure alarm disappears.
APNEA alarm 4. Turn the mode switching knob on the front
of this device to the backup ventilation mode.
5. Check that the APNEA alarm LED flashes after 10
seconds and the buzzer sounds intermittently.
6. Simulate the breathing of a person by closing
and opening the test lungs.
7. After a while, check that the APNEA alarm LED
goes off and the buzzer stops sounding.
Flow sensor 4. Unplug the flow sensor plug from the
alarm PROX.FLOW SENSOR terminal on the front of the
main unit.
5. At this time, check that "----" flashes in the tidal
volume display area and that the buzzer sounds
intermittently.
6. Reconnect the plug.
7. Set the “Mode switching knob” to “Backup” mode
and switch to “Mandatory” mode again.
8. Check the sensor alarm stops.
High tidal 4. Keeps the test lung wide open during mandatory
volume alarm ventilation during the expiratory phase.
5. After a while, check that "Hi-" and the ventilation
volume at that time are alternately displayed in
the tidal volume display area, and the buzzer
sounds intermittently.
6. Let go of the test lung and let it sit.
7. After a while, check that "Hi-" and the ventilation
volume at that time are alternately displayed in
the tidal volume display area goes off and the
buzzer stops sounding.
In actual use, if you want to set the current state
as the standard of new tidal volume, operate as
follows.
31
Alarm type How to confirm alarm issuance
Low tidal 4. Hold the test lung by hands during mandatory
volume alarm ventilation during the inhalation phase.
5. After a while, check that "Lo-" and the ventilation
volume at that time are alternately displayed in
the tidal volume display area, and the buzzer
sounds intermittently.
6. Let go of the test lung and let it sit.
7. After a while, check that "Lo-" and the ventilation
volume at that time are alternately displayed in
the tidal volume display area goes off and the
buzzer stops sounding.
In actual use, if you want to set the current state
as the standard of new tidal volume, operate as
follows.
8. Press and hold the Auto set button for 2 seconds
or longer while the Hi tidal volume alarm is being
generated.
9. The tidal volume display area blinks and a new
tidal volume measurement starts.
10.After a while, the blinking will stop and a new
value for the tidal volume alarm will be set.
High breath 4. Open and close the test lung by hands every 2
rate alarm seconds.
5. After a while, check that "Hi" flashes in the
Breath rate display area and the buzzer sounds
intermittently.
6. Release the test lung and return to their original
condition.
7. After a while, check that "Hi" in the Breath rate
display area goes off and the buzzer stops
sounding.
Alarm mute
You can intentionally turn off the alarm sound.
The alarm sound will be muted for 30 seconds by pressing the mute button while the
alarm buzzer is sounding.
It is not possible to mute the warning buzzer sound of the power failure alarm.
● If an alarm occurs, be sure to remove the cause before clearing the alarm. Also,
always have an alternative manual respirator available.
Warning ● Do not block the hole located on right down of front panel so that the alarm sound
can be heard by the operator at any time.
32
Device setting
PIP settings
Set the PIP necessary for treating the patient based on the guidance of the doctor.
[1] When performing this operation, connect the test lung to the end of HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to the "Mandatory
Ventilation" position.
[4] Press the “Select” button until the “PIP” display area flashes.
Each time the Select button is pressed, PIP → PEEP → Breath Rate → Insp.Time
→ APNEA → PIP…. are selected in a cycle.
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
PIP can be set from 0 to 80cmH2O in 1cmH2O increments.
Note that PIP values lower than PEEP cannot be set.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
33
[6] Press the “Auto set” button when all the settings are completed.
● By pressing the automatic setting button, the alarm range is set automatically.
● The pressure of the “PAW MONITOR” terminal is displayed as an analog bar on the
pressure display bar LED in the center of the device.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
● To prepare for an emergency when using this device, prepare another respirator
(such as an AMBU bag to which PEEP and oxygen gas can be added) in case the
device stops working for some reason.
Warning ● Use this device under the supervision of a medical staff who can handle abnormal
situations correctly.
● Do not exceed the time or amount required for diagnosis or treatment. It has a
significant impact on the patient.
● Set the PIP, PEEP, respiratory rate, inspiratory time, etc. so that they do not
Prohibited become incompatible with the patient's respiratory physiology.
● When performing each button operation, do not duplicate it with other operations.
If you continue the duplicate operation, the previous operation may continue.
● Before using this device, be sure to check that it operates normally with normal
ventilation before using it.
● Continuously monitor the device and patient for abnormalities.
● If any abnormality is found in this device and the patient, take appropriate
measures such as stopping the operation of this device in a safe condition for the
patient.
● Please note the time and amount required for diagnosis and treatment according
Caution to the patient's condition.
● Caution should be taken so that the patient does not touch the device.
34
PEEP settings
Set the PEEP necessary for treating the patient based on the guidance of the doctor.
[1] When performing this operation, connect the test lung to the end of HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to the "Mandatory
Ventilation" position.
[4] Press the “Select” button until the “PEEP” display area flashes.
Each time the Select button is pressed, PIP → PEEP → Breath Rate → Insp.Time
→ APNEA → PIP…. are selected in a cycle.
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
PEEP can be set from 0 to 20cmH2O in 1cmH2O increments.
Note that PEEP values higher than PIP cannot be set.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
35
[6] Press the “Auto set” button when all the settings are completed.
● By pressing the automatic setting button, the alarm range is set automatically.
● The pressure of the “PAW MONITOR” terminal is displayed as an analog bar on the
pressure display bar LED in the center of the device.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
● Assuming an emergency when using this device, prepare another respirator (such
as an AMBU bag to which PEEP and oxygen gas can be added) in case the device
stops working for some reason.
Warning ● Use this device under the supervision of a medical staff who can handle abnormal
situations correctly.
● Do not exceed the time or amount required for diagnosis or treatment. It has a
significant impact on the patient.
● Set the PIP, PEEP, respiratory rate, inspiratory time, etc. so that they do not
Prohibited become incompatible with the patient's respiratory physiology.
● When performing each button operation, do not duplicate it with other operations.
If you continue the duplicate operation, the previous operation may continue.
● Before using this device, be sure to check that it operates normally with
normal ventilation before using it.
● Continuously monitor the device and patient for abnormalities.
● If any abnormality is found in this device and the patient, take appropriate
measures such as stopping the operation of this device in a safe condition for the
patient.
● Please note the time and amount required for diagnosis and treatment
Caution according to the patient's condition.
● Caution should be taken so that the patient does not touch the device.
36
Breath Rate settings
Set the Breath Rate necessary for treating the patient based on the guidance of the
doctor.
[1] When performing this operation, connect the test lung to the end of the HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to the "Mandatory
Ventilation" position.
[4] Press the “Select” button until the “Breath Rate” display area flashes.
Each time the Select button is pressed, PIP → PEEP → Breath Rate → Insp.Time
→ APNEA → PIP…. are selected in a cycle.
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
Breath rate can be set from 1 to 255 BPM in 1 BPM increments.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
37
[6] Press the “Auto set” button when all the settings are completed.
● By pressing the automatic setting button, the alarm range is set automatically.
● The pressure of the “PAW MONITOR” terminal is displayed as an analog bar on the pressure
display bar LED in the center of the device.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
● Assuming an emergency when using this device, prepare another respirator (such
as an AMBU bag to which PEEP and oxygen gas can be added) in case the device
stops working for some reason.
Warning ● Use this device under the supervision of a medical staff who can handle abnormal
situations correctly.
● Do not exceed the time or amount required for diagnosis or treatment. It has a
significant impact on the patient.
● Set the PIP, PEEP, respiratory rate, inspiratory time, etc. so that they do not
Prohibited become incompatible with the patient's respiratory physiology.
● When performing each button operation, do not duplicate it with other operations.
If you continue the duplicate operation, the previous operation may continue.
● Before using this device, be sure to check that it operates normally with
normal ventilation before using it.
● Continuously monitor the device and patient for abnormalities.
● If any abnormality is found in this device and the patient, take appropriate
measures such as stopping the operation of this device in a safe condition for the
patient.
● Please note the time and amount required for diagnosis and treatment
Caution according to the patient's condition.
● Caution should be taken so that the patient does not touch the device.
38
Inspiration time settings
Set the Inspiration time necessary for treating the patient based on the guidance of
the doctor.
[1] When performing this operation, connect the test lung to the end of the HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to the "Mandatory
Ventilation" position.
[4] Press the “Select” button until the “Insp. Time” display area flashes.
Each time the Select button is pressed, PIP → PEEP → Breath Rate → Insp.Time
→ APNEA → PIP…. are selected in a cycle.
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
Inspiration time can be set from 0.1 to 3.0 seconds in 0.1 second increments.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
39
[6] Press the “Auto set” button when all the settings are completed.
● By pressing the automatic setting button, the alarm range is set automatically.
● The pressure of the “PAW MONITOR” terminal is displayed as an analog bar on the
pressure display bar LED in the center of the device.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
● Assuming an emergency when using this device, prepare another respirator (such
as an AMBU bag to which PEEP and oxygen gas can be added) in case the device
stops working for some reason.
Warning ● Use this device under the supervision of a medical staff who can handle abnormal
situations correctly.
● Do not exceed the time or amount required for diagnosis or treatment. It has a
significant impact on the patient.
● Set the PIP, PEEP, respiratory rate, inspiratory time, etc. so that they do not
Prohibited become incompatible with the patient's respiratory physiology.
● When performing each button operation, do not duplicate it with other operations.
If you continue the duplicate operation, the previous operation may continue.
● Before using this device, be sure to check that it operates normally with
normal ventilation before using it.
● Continuously monitor the device and patient for abnormalities.
● If any abnormality is found in this device and the patient, take appropriate
measures such as stopping the operation of this device in a safe condition for the
patient.
● Please note the time and amount required for diagnosis and treatment
Caution according to the patient's condition.
● Caution should be taken so that the patient does not touch the device.
40
APNEA settings
Set the APNEA necessary for treating the patient based on the guidance of the
doctor.
[1] When performing this operation, connect the test lung to the end of the HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to the "Mandatory
Ventilation" position.
[4] Press the “Select” button until the “APNEA” display area flashes.
Each time the Select button is pressed, PIP → PEEP → Breath Rate → Insp.Time
→ APNEA → PIP…. and the blinking area are advanced in order.
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
APNEA can be set from 1 to 60 seconds in 1 second increments.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
41
[6] Press the “Auto set” button when all the settings are completed.
● By pressing the automatic setting button, the alarm range is set automatically.
● The pressure of the “PAW MONITOR” terminal is displayed as an analog bar on the
pressure display bar LED in the center of the device.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
● Assuming an emergency when using this device, prepare another respirator (such
as an AMBU bag to which PEEP and oxygen gas can be added) in case the device
stops working for some reason.
Warning ● Use this device under the supervision of a medical staff who can handle abnormal
situations correctly.
● Do not exceed the time or amount required for diagnosis or treatment. It has a
significant impact on the patient.
● Set the PIP, PEEP, respiratory rate, inspiratory time, etc. so that they do not
Prohibited become incompatible with the patient's respiratory physiology.
● When performing each button operation, do not duplicate it with other operations.
If you continue the duplicate operation, the previous operation may continue.
● Before using this device, be sure to check that it operates normally with
normal ventilation before using it.
● Continuously monitor the device and patient for abnormalities.
● If any abnormality is found in this device and the patient, take appropriate
measures such as stopping the operation of this device in a safe condition for the
patient.
● Please note the time and amount required for diagnosis and treatment
Caution according to the patient's condition.
● Caution should be taken so that the patient does not touch the device.
42
Inspiratory trigger level settings
This device can tune the inspiratory trigger level according to the patient's condition.
Set an appropriate inspiratory trigger level according to the doctor's instruction.
[1] When performing this operation, connect the test lung to the end of the HMEF.
[2] Set the power switch on the back of the main unit to "l" ON.
[3] Turn the “Mode switching knob” on the front of this machine to other tahn "Off"
position.
Here, turn to the "Mandatory Ventilation” mode and proceed with the
explanation.
[4] By holding down and press the “MUTE” button and “Auto set” button for 2
seconds or more at the same time, the “Tidal Volume display” area blinks and
the inspiratory trigger level can be adjusted.
43
[5] While the value is blinking, turn the “Numerical value setting knob” and change
the value in the setting display to the desired value.
Flow inspiratory level can be set from 1 to 100 in 1 increments.
1 on the display means 0.1L and 100 on the display means 10L.
During the operation of changing the numerical value, a confirmation beep is emitted to prompt
the operator to make the change.
[6] By pressing the Select button, the set Inspiratory trigger level is decided and
saved.
Most settings are confirmed by pressing the Auto Select button. However confirmation for this
inspiratory trigger setting is confirmed by pressing Select button, NOT Auto Select.
[7] Turn the “Mode switching knob” on the front of this machine to the "OFF"
position.
[8] Once set up, remove the test lung and connect the intubation tube to the HMEF.
44
Adjustment of oxygen concentration (FiO2)
The oxygen concentration of the fresh gas supplied to the patient is managed with
the blender. This explanation is based on the Eliciae MV20’s standard blender, but
the facility may decide to use an alternative tool for blending the air and oxygen.
[1] Make sure that the AIR “air” flow rate adjustment knob (yellow) on the
accessory blender is turned to the right and closed.
[2] Turn the O2 "oxygen" flow rate adjustment knob (green) on the accessory
blender to adjust to 15 LPM.
[3] Measure the fraction of oxygen in the fresh gas supply with an FiO2 monitor
owned by the facility and check the adjusted inhaled oxygen concentration.
The following table shows the flow rate values of air and oxygen to obtain the respective inhaled
oxygen concentrations.
45
Use of this device
After setting PIP, PEEP, Respiratory rate, Inspiratory time, APNEA and Inspiratory
trigger level in the section of Device setting, it is ready for actual use.
Before using it on a patient, reconnect the test lung to the HMEF , and reconfirm the
operation in the mode to be used.
Types of modes
This device has three modes;
Monitor mode, Backup Ventilation mode, and Mandatory Ventilation mode.
Monitor mode
This mode is used to measure and display the tidal volume of the patient without
performing ventilation. This device does not ventilate in monitor mode.
[1] Set the power switch on the back of the main unit to "l" ON.
[2] Turn the “Mode switching knob” on the front of this device to the "Monitor"
position.
[3] The tidal volume, PIP, and PEEP are displayed from the top on the right side of
the front of the device.
[4] Replace the test lung with an intubation tube and intubate the patient's airways.
46
Backup ventilation mode
In this mode, the PIP, PEEP, breathing rate, and APNEA time are set, and when
there is no spontaneous breathing detected for more than the APNEA set time, the
patient is mandatory ventilated.
[1] Set the power switch on the back of the main unit to "l" ON。
[2] Turn the “Mode switching knob” on the front of this device to the position of
"Backup Ventilation".
[3] Confirm that the device is operating with the set values and that the monitor
display is correct.
[4] Then remove the test lung and attach an with an intubation tube
[5] While using the device on a patient, be aware of the alarms on this device and
the vital signs monitor of the combined device at the same time.
47
Mandatory ventilation mode
In this mode, the PIP, PEEP, respiratory rate, and inspiratory time are set and the
patient is mandatory ventilated.
This mode is mainly used to treat patients infected with new type pneumonia.
[1] Set the power switch on the back of the main unit to "l" ON.
[2] Turn the “Mode switching knob” on the front of this device to the "Mandatory
Ventilation" position.
[3] Confirm that the device is operating with the set values and that the monitor
display is correct.
[4] Then remove the test lung and attach an with an intubation tube
[5] While using the device on a patient, be aware of the alarms on this device and
the vital signs monitor of the combined device at the same time.
Caution Pay attention with alarms on the device and the vital signs monitor.
48
Clean up after use
Turning off the mode
Turn the mode switching knob on the front of the main unit to "〇” Off.
Turn on the power switch "l" for about 8 hours once a month to charge the battery inside the
device.
49
Disconnecting power and removing the power cord
※ Refer to Connection to power supply.
[1] Check that the power switch on the back of this device is turned “〇” off.
[2] Hold the AC plug of the AC power cord from the power outlet and pull it out.
[3] Lift the inlet terminal lock lever on the back of this device to unlock the AC
power cord.
[4] With the lock lever raised, hold the plug of the power cord and pull out the AC
power cord from the inlet terminal on the back of this device.
Do not pull out the power cord by holding the cord part.
Prohibited
Always hold the plug when pulling out the power cord. If you pull on the cord
to pull it out, the power cord may break.
50
Removal of driving gas (air)
※ Refer to Driving gas connection (air).
[1] Turn the gas supply ring to unlock and pull out the Y-type pressure gas tube
(air).
[2] Use a tool such as a wrench to loosen and pull out the nut of the Y-type
pressure gas tube (air) connected to the “GAS INLET” port on the back of the
main unit.
Nut
[3] Loosen the nut of the Y-type pressure gas pipe (air) connected to the air
connection port on the back of the attached blender with a tool such as a
spanner, and pull it out.
Nut
51
Removal of driving gas (oxygen)
※ Refer to Driving gas connection (oxygen).
[1] Turn the gas supply ring to unlock and pull out the pressure gas tube (oxygen).
[2] Use a wrench or other tool to loosen the pressure gas tube (oxygen) nut
connected to the gas connection port on the back of the attached blender, and
then pull it out.
Nut
52
Blender removal
※ Refer to Blender installation.
[1] On the connector at the front of the blender, pull out the fresh gas tube that is
attached to the breathing circuit. If the fresh gas tube cannot be removed even
after pulling hard, then use a cutter or knife to cut the tube. Then cut any tube
remaining on the terminal connector with a knife to remove it.
[2] Pull the attached blender upward from the blender holder on the side of the
main unit.
Blender
Blender bracket
53
Removal of HMEF
※ Refer to Connection of HMEF.
[1] Hold both the HMEF and the flow sensor with each hand, and disconnect the
HMEF from the flow sensor by pulling them apart.
HMEF
Flow sensor
[1] Hold the ring marked "→" on the plug of the attached sensor cable and pull it
toward you.
The plug is unlocked and you can pull it out.
「→」 mark
Sensor cable
connector
54
Removing the flow sensor and the sensor cable
※Refer to Connecting the flow sensor and the sensor cable.
※The sensor cable is REUSABLE so please handle with care.
[1] Hold the flow sensor with one hand and the sensor mounting part with the other
hand.
Unlock the claw on the sensor mounting part and remove the flow sensor.
[2] The flow sensor can be removed from the sensor mount.
Flow sensor
[3] Disconnect the flow sensor cable from the tube holder used in the attached
breathing circuit set.
● Do not remove the sensor holding the cable root. It may break the
cable.
● Do not touch the metal pattern pins of the flow sensor board and
Prohibited sensor mounting part with your fingers. Skin oil may cause contact
corrosion and cause contact failure.
55
Breathing circuit removal
※Refer to Breathing circuit connection.
[1] Hold the pressure monitor tube near the “PAW MONITOR” terminal and pull it
straight out from the “PAW MONITOR” terminal on the front of the main unit.
Pressure
monitor tube
[2] Hold the breathing tube at the cuff near the “OUTLET” terminal on the front of
the main unit. Pull the breathing tube out while rotating it if needed.
Breathing tube
56
Optional scavenger removal
※Refer to Optional scavenger system installation.
For details, please read the instruction manual attached to the scavenger system
carefully.
[1] The scavenger system is infected with COVID-19, so be sure to provide suitable
protection for staff handling it.
[2] Disconnect the scavenger system’s 5,000mm Vacuum tube from the facility
suction terminal.
[3] Disconnect the scavenger system’s 5,000mm Vacuum tube from the connector
on the scavenger duct.
[4] Disconnect the scavenger system’s 300mm vacuum tube from the connector on
the scavenger duct.
[5] Disconnect the scavenger system’s 300mm vacuum tube from the exhaust port
adapter on the back of the main unit.
[6] The 300mm and 5,000mm Vacuum tubes should be disposed of after taking
measures against cross-infection.
Disinfect the scavenger duct according to the instructions attached to the
scavenger duct before reuse.
57
Maintenance and inspection
Cleaning the main unit
The main body of Eliciae MV20 cannot be sterilized.
Use a soft waste cloth moistened with a neutral detergent to clean the outside of the main
unit.
Wipe the display with a mild detergent or alcohol (76.9 to 81.4 vol%) using a soft cloth.
First, take out the built-in Jet Assembly from this device. To remove it, follow the procedure
below.
Divide the jet assembly taken out into 4 parts, Jet Body, breathing circuit connection port,
relay tube and exhaust adapter, sterilize each separately.
After sterilization is complete, reassemble the device in the original location in the reverse
order of removal.
58
Item Specifications
Sterilization method High-pressure steam sterilization
Sterilization 121℃ 20min
temperature and
sterilization time
Maximum number of Max. 300 times
sterilization cycles for
guaranteed safe use
If the operating time exceeds 2,000 hours, when the mode switch is changed from
"OFF", the actual ventilation time will blink in the tidal volume display area for about
5 seconds, and the intermittent sound of the alarm will sound.
■Inspection contents
No. Inspection items
1 EP valve replacement
2 Main unit disassembly and cleaning, replacement of designated parts, adjustment,
comprehensive inspection
3 Confirmation of electrical safety and performance
4 Calibration
Metran recommend to carry out regular inspections and overhauls (charged). Please
contact your local distributor for details.
Or you can contact Metran directly via the following web-page:
https://www.metran.co.jp/en
59
How to replace the fuses
If the fuse blows, replace it as follows.
Caution Replace two fuses with new ones at the same time.
60
Built-in battery
The main unit is equipped with a battery for power failure alarm.
This device has a built-in battery in addition to the commercial power source to
activate the power failure alarm.
Item Description
Battery specifications Ni-MH battery
Manufacturer name VARTA
Battery model number 3/V150H
Battery life 6 years
Purpose of battery use For issuing an alarm when the power supply is cut off
unintentionally while using this device
This device does not have a clock display function, but it has a clock function for the
purpose of maintenance and log management.
Item Description
Battery specifications Coin battery
Manufacturer name NA
Battery model number CR2032
Battery life 2 years, but with new product installed
Purpose of battery use For holding the RTC of the MCU built into this device
61
About maintenance mode
The following selections/adjustments can be done while in maintenance mode: ⑬
Adjusting inspiration trigger, ⑮ Activation of inspiration trigger buzzer, and ⑯
Adjustment of buzzer volume.
① ① Current setting
(cannot be operated)
⑫ ③ Finished setting
Adjusting Inspiration
⑬ trigger
63
Activation of inspiration
⑮ trigger buzzer
64
Adjustment of buzzer
⑯ volume
65
While pressing the “MUTE” button and the “Auto set” button
on the front of the main unit at the same time, turn the + +
“Mode switching knob” to the “Monitor” position.
The display on the right will appear when entering
Mode number Adjusted value
maintenance mode.
Item
number
The device won't operate while in the maintenance mode, it will not work even if the “Mode
switching knob” is switched to “Mandatory Ventilation” or “Backup Ventilation” mode.
62
⑬ Adjusting Inspiration trigger
Operation description Procedure pictures
Turn on the power switch "l" ON the back of
the main unit.
63
⑮ Activation of inspiration trigger buzzer
Operation description Procedure pictures
Turn on the power switch "l" ON the back of
the main unit.
Turn the value setting knob to the desired Adjusted value Buzzer
trigger level.
The settings are “01” inspiration trigger enabled
buzzer enabled and “00” inspiration trigger
buzzer disabled.
The set value is displayed in the tidal disabled
volume display area.
The default is displayed as “01”.
After setting, the last set value is displayed.
When the adjustment value is decided, During
press the “Select” button to confirm it. ② setting
Confirmation ends when the item number
↓
(PEEP display area) changes from ② to ③.
Finished
③
setting
You can return to the previous item by
pressing the “MUTE” button. Before
64
⑯ Adjustment of buzzer volume
Operation description Procedure pictures
Turn on the power switch "l" ON the back of
the main unit.
By turning the “Numerical value setting knob”, ① to ⑫, and ⑭ are displayed on the peak
airway pressure setting display, but they cannot be operated.
If you do not know what to do even if an alarm occurs, or if you think there is another
cause, be sure to take the appropriate action for the patient first, and then refer to the
action in the table below.
The table below shows troubleshooting mainly due to the device. Trouble caused by the
condition of the patient is not considered.
The trouble occurrence frequency and severity are not related to the order described in the
table.
66
Display Reason Actions
The pressure at the Press the automatic setting button on
pressure monitor the front of this device to reset the
connection does not exceed alarm range.
the threshold value of the
circuit disconnection alarm
during inspiration.
High circuit failure alarm
Low gas supply setting
Leak from the breathing ・ Check if the breathing circuit is
circuit broken or cracked.
・ Make sure that the connection points
such as the respiratory circuit
connector are firmly connected.
The gas pressure of the Check the gas pressure and leak status
supply gas source is low of the supply gas source.
The AC plug of the power Firmly insert the AC plug of the power
cord is not properly cord into the AC power outlet
connected to the outlet or is
about to come off
The power cord is about to Insert the power cord into the inlet
come off because the inlet terminal as far as it will go and lower the
terminal lock lever on the lock lever to secure the power cord.
back of this device is not
used.
The mode switch was Turn the power switch on the back of
turned while the power this device to "l" and then operate the
Power failure
switch on the back of this mode switch.
device was "○" OFF.
The fuse in the inlet is Remove the cause of blown fuse and
blown replace with a new fuse
Refer to how to replace the fuse in P.45.
There was a power failure Please use uninterruptible power outlets
by connecting the power to avoid power failure
cord to a general
commercial power source.
Uninterrupted power Follow the instruction manual for the
system battery exhaustion uninterrupted power supply system
Patient's spontaneous It is not abnormality.
breath exceeds APNEA In backup ventilation mode, active
alarm set time ventilation will start at the same time as
APNEA the alarm.
If mandatory ventilation does not start,
turn the mode switching knob to switch
to mandatory ventilation.
67
Display Reason Actions
Incomplete insertion of flow Insert the flow sensor cable plug into
sensor cable plug the “PROX. FLOW SENSOR” terminal on
the front of the main unit until it clicks
into place.
If the problem cannot be resolved, the
sensor cable may be broken.
Consult your dealer for a new sensor
cable.
Incomplete installation of Firmly attach the flow sensor to the
flow sensor sensor mounting part until it locks into
place.
If the problem cannot be resolved, the
sensor cable may be broken.
Consult your dealer for a new sensor
cable.
Flow sensor Water (condensation) If the flow sensor is set horizontally and
gathered in flow sensor the probe part is facing downwards,
probes then condensation in the patient circuit
may gather in the flow sensor probes
causing incorrect output from the
sensor. To correct this, twist the sensor
and ensure that the flow detection
probes are positioned on the upper
side.
Forgot to operate “Mode Even if the cause of the problem is
switching knob” removed, it will not automatically
recover.
Switch the “Mode switching knob” and
set it to “Mandatory Ventilation” mode
again and confirm that the alarm
disappears.
The standard ventilation After the start of ventilation operation,
volume is not measured the first 6 breaths are measured and
correctly used as the reference for tidal volume.
This measurement may be incorrect.
Re-measure the tidal volume by pressing
and holding the “Auto set” button on the
front of the main unit for 2 seconds or
High tidal volume longer. The tidal volume display area
blinks during measurement.
The patient's breath Re-measure the tidal volume by pressing
changed and holding the “Auto set” button on the
front of the main unit for 2 seconds or
longer. The tidal volume display area
blinks during measurement.
68
Display Reason Actions
The standard ventilation After the start of ventilation operation,
volume is not measured the first 6 breaths are measured and
correctly used as the reference for tidal volume.
This measurement may be incorrect.
Re-measure the tidal volume by pressing
and holding the “Auto set” button on the
front of the main unit for 2 seconds or
Low tidal volume longer. The tidal volume display area
blinks during measurement.
The patient's breath Re-measure the tidal volume by pressing
changed and holding the “Auto set” button on the
front of the main unit for 2 seconds or
longer. The tidal volume display area
blinks during measurement.
Patient's condition changed Eliminate the cause of rapid breathing
High breath rate and breathing became immediately, or reset the breath rate if
faster the breathing is appropriate.
When an alarm occurs, eliminate the cause immediately. It may have a great
Warning impact on the patient.
Do not lower the alarm volume. The abnormal condition may not be
Prohibited recognized, and the patient is greatly affected.
69
■Troubleshooting
If you do not know what to do with the problem, or if you suspect it has another cause, be
sure to take the appropriate action for the patient first and then refer to the action in the
table below.
The table below shows troubleshooting mainly due to the device. Troubles caused by the
conditions of the patient are not considered. Refer to the countermeasures related to the
alarm display.
The trouble occurrence frequency and severity are not related to the order described in the
table.
70
Others
About storage
Storage conditions
Temperature -20 ~ 60 ℃
Relative 0 ~ 95 %RH (without condensation)
humidity
● Store in a place where it will not come into contact with liquids.
● Store in a place where there is no possibility of adverse effects due to
temperature, humidity, ventilation, sunlight, dust, air containing salt, sulfur,
etc.
● A place where chemicals are stored or where no gas is generated.
● Store in a place where consideration is given to safety such as tilt, vibration,
and shock (including during transportation).
About transportation
Transportation conditions
Temperature -20 ~ 60 ℃
Relative 0 ~ 95 %RH (without condensation)
humidity
● Store in a place where it will not come into contact with liquids.
● Store in a place where there is no possibility of adverse effects due to
temperature, humidity, ventilation, sunlight, dust, air containing salt, sulfur,
etc.
● Store in a place where consideration is given to safety such as tilt, vibration,
and shock (including during transportation).
About disposal
■Disposal of this device and its accessories
■Battery disposal
Please dispose in accordance with the regulations of your local
government.
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Technical data
Basic data
Specifications
Ventilation Backup ventilation
mode Mandatory ventilation
Gas supply 3.5 ~ 5 kgf/cm2
Ventilation type Time pressure limited type
Ventilation PIP 0 ~ 80 cmH2O / 1 cmH2O
functions PEEP 0 ~ 20 cmH2O / 1 cmH2O
Breath rate 1 ~ 255 BPM / 1 BPM
Inspiration time 0.1 ~ 3.0 sec / 0.1 sec (inverted ratios not allowed)
Paw high LED alarm, audio alarm and auto alarm setting
Paw low LED alarm, audio alarm and auto alarm setting
Low gas supply LED alarm, audio alarm and auto alarm setting
Power failure LED alarm, audio alarm
Apnea LED alarm, audio alarm
Alarms Flow sensor Tidal volume monitor “- - - -” blinks
Hi-Lo tidal volume Tidal volume monitor area blinks and auto alarm
setting
Breath rate setting monitor area blinks and auto alarm
High breath rate
setting
Alarm mute 30 seconds
20 ~ 99 mL ±5%
Tidal volume
100 ~ 2,000 mL ±10%
Peak inspiratory 0 ~ 80 cmH2O ±10%
pressure
Monitoring PEEP 0 ~ 20 cmH2O ±10%
Airway pressure -10 ~ 80 cmH2O ±2 cmH2O
APNEA monitor 1 ~ 60sec. depending on flow trigger sensitivity
Minute volume Total litters per minute
Total breath rate Total number of breaths spontaneous or mechanical
Input power AC 100 to 240V 50/60Hz
Power consumption 40VA
External dimensions (W) 260mm × (H) 190 mm × (D) 283mm
of the main unit (Excluding the largest protrusion)
Weight of the main
6.0 kg
unit
IP protection class IPX0
Blender
Y-type pressure gas tube (air) *
Others Pressure gas tube (oxygen) *
Breathing circuit set (disposable)
Accessories
Flow sensor (disposable)
Flow sensor cable
HMEF (disposable)
Power cord
Cart
Option Support arm
Scavenger system
Combined equipment Vital signs monitor
* In countries where the main unit is driven by oxygen, the combination of the pressure gas
tubes may be different. Please contact your distributor for details.
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Environmental conditions in use and life span
Terms of use
Working pressure range 3.5 ~ 5 kgf/cm2
Airway pressure range 0 ~ 80 cmH2O
PEEP range 0 ~ 20 cmH2O
Airway pressure monitor range -10 ~ 80 cmH2O ± 2 cmH2O
APNEA monitor range 1 ~ 60 secs depending on trigger sensitivity
Classification by type of protection
Class Ⅰ device
against electric shock
Classification by degree of
B type device
protection against electric shock
Degree of protection against
harmful ingress of water or IPX0
particulate matter
External dimensions of the main (W) 260mm × (H) 190mm × (D) 283mm
unit (Excluding the largest protrusion)
Weight of the main unit 6.0 kg
Power supply voltage/power AC100 to 240V, 50/60 Hz,
consumption 40VA
6 years after delivery
However, only if specified maintenance/inspections are
Life span
performed
Accessories are excluded
Operating environment
5 ~ 40 ℃
temperature range
Operating environment humidity
0~ 95 %RH (without condensation)
range
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Information
Responsibility for the patient safety
Read the instructions in this operation manual for safe and correct use of this ventilator.
The design, manuals, and labels of this device were designed to be understood by people
with general knowledge and training in artificial ventilators. The manual indications, notes
and warnings are based on the device structure. In this manual we are not discussing the
dangers of improper use of the device resulting in troubles, or bad effects to the patient
which are fully understood by the medical worker. The manufacturer will not be responsible
for risk well known by the medical professional, trouble caused by misuse or side effects in
the patient. The manufacturer will not be responsible for the results of combination with
others devices that are not recommended by the manufacturer.
Operating conditions and selection of the patient monitoring type must be the operator’s
responsibility. The operator will be responsible for selection of devices needed in patient
monitoring. Electronic devices cannot replace visual check and observation of the patient
conditions by the medical worker.
Warranty
ELICIAE MV20 ventilator (the equipment) is warranted to be free from defects in material
and workmanship and to meet the published specifications for one (1) year from the date of
delivery of the equipment to the original purchaser.
Exclusions
Metran Co., Ltd. (the company) shall not be responsible for any damage or failure caused
indirectly or directly by operation of the equipment outside of the allowable electrical,
temperature and other environmental limits specified by the company, or by deficiencies in
customer-supplied services or supplies.
The company will not be responsible for deterioration, wear out and mishandling or
accidental damage of the equipment.
The equipment is supplied with some components and accessories, which by their nature are
not intended to, and will not, function for one year. If any such component or accessory
manufactured by the company and supplied with the equipment fails to give reasonable
service for a reasonable period of time, the company will, at its discretion, replace or repair
such component or accessory. What constitutes reasonable service and a reasonable period
of time shall be determined by the company after the company is in possession of all the
facts concerning said component or accessory, and after said component or accessory has
been returned to the company with transportation charges prepaid.
The company makes no warranty concerning components or accessories not manufactured
by or for the company.
The company shall be released from all obligations under this warranty in the event that
repairs or modifications to the equipment are made by persons other than personnel trained
and/or authorized by the company. Any authorization by the company for repair or alteration
by the Buyer must be in writing to prevent voiding of the warranty. In no event shall the
company be liable to the Buyer for loss of profits, loss of use, consequential damage or
damages of any kind based upon a claim for breach of warranty, other than the purchase
price of any defective product covered hereunder.
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Exclusive Remedy
The liability of Metran Co., Ltd. (the company) under this warranty is limited to replacing,
repairing or issuing credit, at the discretion of the company, for parts that become defective
or fail to meet published specifications during the warranty period. The company will not be
liable under this warranty unless (A) the company is promptly notified in writing by Buyer
upon discovery of defects or failure to meet published specifications within four weeks from
delivery; (B) the defective unit or part is returned to the company, transportation charges
prepaid by Buyer; (C) the defective unit or part is received by the company for adjustment
no later than four weeks following the last day of the warranty period; and (D) the
company’s examination of such unit or part shall disclose, to its satisfaction, that such
defects or failures have not been caused by misuse, neglect, improper installation,
unauthorized repair, alteration or accident.
Disclaimers
Metran Co., Ltd. warranties as herein and above set forth shall not be enlarged, diminished
or affected by, and no obligation or liability shall arise or grow out of the rendering of
technical advice or service by Metran Co., Ltd. or its agents in connection with the Buyer's
order of the products furnished hereunder.
The foregoing is in lieu of any warranty, expressed or implied, including, without limitation,
any warranty of merchantability, except as to title, and can be amended only in writing by a
duly authorized representative of Metran Co., Ltd.
Glossary
Symbol Explanation
LED Light Emitting Diode
AC Alternating current
DC Direct current
V Voltage
A Ampere
Hz Hertz
kg Kilogram
sec Second
cmH2O Centimeters of water (unit of pressure)
mL Milliliter
kPa kilo Pascal
APNEA Absence of breath
BPM Breaths per minute
LPM Liters per minute (unit of flow)
I:E ratio Inspiratory and expiratory phases time ratio
IPPV Intermittent positive pressure ventilation
PCV Pressure-controlled ventilation
PEEP Positive end-expiratory pressure
PIP Peak Inspiration Pressure
HMEF Humidity moister exchanger filter
75
<Manufacturer>
Metran Co.,Ltd.
URL:http://www.metran.co.jp/en
<Agency>
<Manual number>
M62-089-01
Date:August 18, 2020
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