mtv1000 Userman
mtv1000 Userman
Since this user’s manual is compatible with MTV1000 Ventilator, it may not be used with other
products manufactured by our company. In case of loss or damage in user’s Manual, you may
refer to MEK-ICS web site for downloading the manual file.
URL: http://www.mek-ics.com
MTV1000 user’s manual includes precautions and risks to users prior to use of ventilator.
Please read all precautions for use thoroughly before operating the product.
You may easily find information with the table of contents during operation.
If you have any inquiries on details of the product, contact our company or visit Customer
Service Center.
1.1 Cautions
This document contains proprietary information that is protected by copyright.
Under copyright law, this document cannot be reproduced, modified or otherwise amended
without prior approval.
1.2 Warranty
Contents in this publication may change without notice.
MEKICS takes no responsibility for any problems and damages caused by performance or
different data from the details of this document.
1.4 Symbols
Symbols appear on the interior and exterior of the product and in this User Manual.
The symbols represent important cautions and advice to the user. Please read the following
symbols carefully and be well informed of them for the use and storage of the product.
DANGER
This symbol represents “DANGER.”
It is associated with possible matters that may greatly harm the product or the patient, or
might even cause the patient’s death.
WARNING
This symbol represents “WARNING.”
It is associated with possible matters that may harm or cause irreversible damage to the
product or the patient.
ATTENTION
This symbol is associated with safety issues that the user should give attention to and be
well informed of before using the product. How to use the product is described in each
section of this manual.
NOTE
This symbol is associated with issues you should note regarding the surrounding
environment or additional references to the descriptions in this manual. It does not pertain
to possible damages to the product or the patient.
▣ This User Manual may differ from the actual product in terms of functionality.
▣ If deemed necessary, the company may make any improvement to the product to enhance
its performance, without prior notification, MEKICS has no obligation to apply the same
specification change to the products already sold.
WARNING
Turn off the product when you do not use it for a while.
WARNING
1. It is extremely dangerous to use or store the product in a place exposed to chemicals
or explosive gases.
2. Do not disjoint or disassemble the product, doing so will cancel the product warranty.
3. Do not connect the product to a power supply before completing the installation. This
may damage the product.
4. Before using the product, ensure that the settings of all the sensors and functions are
correct. Only authorized, well-informed personnel should use the Ventilator unit.
5. The proper functionality of the product should be verified regularly.
6. Do not use the product on more than one patient at a time.
7. Do not use the product in a place exposed to high humidity.
8. It is very dangerous to operate the product with wet hands.
9. Do not use the product in a place exposed to direct sunlight.
10. Do not use the product in a place with extreme temperature variations.
The proper temperature ranges from 10C to 40C.
11. Do not use the product near a heating device.
12. Do not use the product in a very humid place or a place with poor ventilation.
13. The proper humidity ranges from 0% to 95%.
14. Do not use the product in a place where the product could be exposed to extreme
impact or vibration.
15. Be careful to prevent dirt, especially metal materials, from getting inside the product.
CAUTION
1. This product is used to determine patient status. Other clinical information must be
used together for accurate diagnosis.
2. Take care not to cause pain on patients from tightening sensors. Also, take care not
to tangle patients with sensor cables.
3. If measurement values displayed on the screen are considered inaccurate, measure
another patient for comparison.
4. Do not use one product on two patients simultaneously.
WARNING
1. The rated power input for this product is AC 100~220V / 50–60Hz.
2. Connect the power plug to an AC power outlet with an earth terminal.
3. Note that neither the company nor any representative of the company will be
responsible for any issues arising from the use of any power source out of the rated
power input.
4. Only authorized personnel who are trained to service the product may disassemble
the product. Note that neither the company nor any representative of the company
will be responsible for any electric shock, short circuit or product damage caused by
unauthorized disassembly. Failure to comply will cancel the product warranty and
make the product ineligible for service.
5. If the power cord or sensor cable is damaged, immediately stop using the product
and replace the power cord or cable. Using the product when the power cord or
sensor cable is damaged may cause an electric shock, short circuit, current leakage
or product damage.
6. Do not bump or move the product while the power cord or sensor cable is connected
to it. This may cause patient injuries or product malfunctions.
7. When using the product with other devices, use a separate AC power source for the
other devices to ensure the patient’s safety.
8. Do not use an anti-electrostatic or conductive tube for the product.
9. Auxiliary equipment and accessories provided by MEKICS are qualified items that
meet electrical safety standards. The use of other companies’ products or unproven
items may cause injury to the patient or product damage.
CAUTION
Only use auxiliary equipment provided by the MEKICS Head Office or MEKICS’
designated representatives.
ATTENTION
1. This product uses 10.8V, 4400mAh (2ea), Li-ion battery.
2. When charging battery, connect the AC cable. Take care to prevent metal substances
from contacting the battery charging terminal.
WARNING
1. A strong electromagnetic wave may affect the performance of the product.
Basically, the product is designed to not suffer functional disorders by surrounding
electromagnetic waves. Notwithstanding, strong electromagnetic waves may cause
the product to malfunction. This may include displaying incorrect calculation values,
disappearance of measurements and noises affecting the wave pattern. If such
errors continue, contact the MEKICS Technical Service Center or authorized dealers
for assistance.
This chapter provides information on the appearance and specifications of the MTV1000
ventilator System.
.
3.1. Overview
This product is a ventilator for adults, pediatric, which configures breathing method, tidal
volume, Respiratory, oxygen concentration and breathing ratio to resolve the hypoxia
shown in pulmonary emphysema or respiratory disease patients. Though the ventilator can
safely manage breathing in a patient using various alarm functions and safety devices,
other clinical information must be used simultaneously for precise diagnosis of patients.
Display
This product displays various ventilation information of the patient on a 7-inch color
TFT LCD. The LCD displays graphs of pressure, volume and flow, as well as
measurement values of the patient. In addition, it is extremely easy to access menu
through touch screen and encoder. Real-time graphs and values can be saved and
represented using trend function, along with various warning messages.
When an alarm sounds function is turned off, an alarm is displayed visually on the
screen.
Electric Performance
The rated voltage of this product is 100VAC – 240VAC. In case of problems in input
power, fuse internalized in the product can be used to protect the product.
Battery pack (Li-ion battery, 10.8V, total 8800mAh) applied to the product includes two
large capacity batteries. The product can be operated up to three hours without AC
power supply. The battery remaining status is displayed at the bottom of the screen. In
addition, the battery pack can easily be attached and detached.
The battery pack can be charged by connecting AC power (100VAC – 240VAC) from
external sources. The battery can be charged more quickly with power-off status.
D E
A B
WARNING
Be careful about polarity when replacing the battery. If polarity is reversed, the product
can be damaged. Prevent the terminal from contacting metals.
For batteries, auxiliary products designated by our company must be used.
A
E
D G
WARNING
If you do not use the Proximal Pressure Port should not cover.
C
E
D
G
ATTENTION
Do not touch RS-232 Port, Video Output Port, USB-A Type Port, and USB-B Type Port with
metal substances. Also, turn off the power when connecting cables to these ports.
A
B
Function Description
Measures patient’s lung resistance, compliance, elasticity, time
Inspiration pause
constant
Manual Inspiration Delivers one mandatory breath
Touch-Key lock Disable touch-key function
Graph freeze Freezes waveform & loop graphs
Alarm silence Turns off alarm sound for 2 minutes
Alarm reset Clear active alarms
Sound Volume Controls alarm sound volume
Item Range
International Standards
This product selected and acquired the following international standards.
Nebulizer
14 Nebulizer is turned On/Off.
(Option)
CAUTION
User must inspect installation state and abnormalities in filters and patient circuit system
every day with unaided eyes. If abnormalities are found, corresponding parts must be
immediately supplemented or replaced.
CAUTION
When changing the patient or every 15 days when using the product long-term for a
patient, patient circuit system including all bacteria filters must be replaced. Used parts
must be cleaned and sterilized.
CAUTION
All components of patient circuit system excluding bacteria filters can be sterilized using
any of ETO (ethylene oxide) gas method, steam autoclave method, and chemical
sterilization method.
However, only steam autoclave method can be used for bacteria filters. Sterilization is
performed for about 20 minutes at 132˚C.
CAUTION
Bacteria filters must be replaced to new filters every year or when the number of
autoclaves reaches 100. For oxygen sensor, lifespan may be reduced by high FiO2 or high
temperature.
WARNING
1. If undesignated, dangerous substances are used for cleaning, no free repair service
will be provided on the damaged product regardless of warranty period.
2. Take care on the main body and sensors after cleaning. Do not use damaged or
aged device.
3. Once a month, clean the exterior of the product using soft cloth soaked in warm
water or alcohol.
4. Do not use lacquer, paint, thinner, ethylene or oxidizer that may damage the
product.
5. Do not place accessories in liquids or detergents.
6. Take care to prevent liquids from entering the product or sensor probe during use.
WARNING
1. Do not arbitrarily dispose of the product.
2. Do not discard disposable sensor in places with risks.
3. Be careful about environmental contamination.
When installing or moving the device, be careful not to place impact on the product.
WARNING
If rating is incorrect, user and product can be damaged.
Power cord must be connected to the outlet attached to the ground.
Damaged power cord or sheath must be replaced.
When external DC power or AC power is connected, power LED is turned on indicating
which power is being supplied.
1
2
3
4
CAUTION
Do not short any pins of Ext. Batt. Connector. It may damage internal electric circuit.
Be careful about polarity when connecting and replacing batteries.
Use rated voltage of 12V DC and current must be 7A or above.
WARNING
Fuse is internalized in the product.
Time Lag Type, 250V, 6.3A
NOTE
Internal battery is not charged while external battery is being used.
WARNING
Battery must be charged before use. Replace the battery if it is considered inadequate.
If battery gets low, measurement information relating ventilation may result in errors. If
remaining battery is low, connect to commercial power.
Be careful about polarity when replacing battery. Connect (+) to red and (-) to black. If
polarity is mistaken, it may damage the product.
Do not short battery terminal. (Battery may explode and cause harm on human body)
Use rated voltage and current. (10.8V, 4400mA)
In case of abnormality in battery, contact [Customer Service team] to receive necessary
follow-up.
CAUTION
Fuse is internalized in the product.
Time Lag Type, 250V, 6.3A
Internal battery can be influenced by the number of discharges during use, degree of
discharge, surrounding temperature, and charging voltage. Battery can ordinarily be used
for two years.
1 AC power on
NOTE
When the product is used over two hours with internal battery, ventilator may not operate
properly. Measurement values such as TIDAL Volume can be relatively small.
WARNING
Place battery connector in the correct position when replacing battery. If the connector is
misplaced, it may damage the product.
CAUTION
All bolts are tightened clockwise and loosened counterclockwise.
WARNING
Since oxygen tank pressure is high, always keep oil away from connector to prevent
explosion.
Before connecting or disconnecting high pressure hose, close oxygen tank valve first.
Check that high Pressure O2 supply pressure is appropriate (35~90 PSI).
High pressure hose must be kept away from people during use and transportation.
If low flow O2 supply is not used, keep low flow O2 port closed up.
WARNING
Filter must be used before connecting the device to the patient.
If accessory has 2 symbol, it is disposable and must not be reused.
In order to use reusable accessories, sterilize and clean them first.
Filters must be provided and designated by our company. Consult with hospital supply
engineer or locally authorized seller when using other products.
This product must only be operated with authorized standard products. Our company is
not responsible for problems caused by use of unauthorized products.
Since accessories are aseptic products, packages must only be opened before use. There
must be no flaws or defects in the packages.
WARNING
When moving the product, keep the LCD frontal. Prior to moving, make sure that parts and
power cords are arranged.
WARNING
When using cart, disable the lock that fixates wheels on the product before movement.
Lock the wheels after movement.
MASK Type
Mask Mask Proximal
Circuit Type
without Exhalation with Exhalation Pressure Port
Hole Hole
Dual limb circuit O X O
Single limb circuit
O X O
with Exhalation valve
SETUP MODE SETTING SETUP
MENU
– Limb Type - MASK ON or OFF - Proximal ON/OFF
CAUTION
Buzzer alarm sound is created when power switch is positioned at stand-by.
If there is no buzzer sound, check the problem in power supply and fuse.
A
A. Click “READY”
button to see
ventilation modes
Selecting screen.
5 Ventilation B. Select appropriate
Mode ventilation mode.
For more details,
refer to “Vent.
Mode” section.
B
A. Set appropriate
Selecting parameters for
6 Ventilation selected vent mode.
Parameter B. Push accept button
to start ventilation.
A. Select “System”
menu ->
C “Patient” button.
Entering B. Input the SVC
Quick Code “97”.
1
ventilation C. Push “Enter” key.
B
mode Then ventilator
will change the
A Quick ventilation
mode.
A. Select “System”
menu ->
“Patient” button.
B. Reinput the SVC
Standby
Code “97”.
4 Screen
C. Push “Enter” key.
Rechanging
The ventilator will
change the
normal
ventilation mode.
Only physicians and competent nursing, technical staff are permitted to access the clinical
screens. The patient must never be told how to access these screens.
MTV1000 allows you to save two sets of ventilation parameters. From the main clinical screen
you can modify the M1 and M2 ventilation mode. When you have entered a program you can
make the desired modifications. There modification is automatically saved when you exit the
clinical setting menu.
B
Selecting a
A. Select M1 or M2 ventilation
ventilation
1 program.
program to
B. Select “Setting” Button.
setup
B
C. Select Patient type.
Selecting
D. Input patient height with
2 Patient type
encoder.
& Height
E. Push “Next” Button.
A C
A. Select “System”
menu -> “Patient”
C button.
Entering B. Input the SVC
Quick Code “95”.
1
ventilation C. Push “Enter” key.
mode B Then ventilator
will change the
Quick ventilation
A mode.
D. Select “System”
menu ->
“Patient” button.
E. Reinput the SVC
Standby
Code “95”.
4 Screen
F. Push “Enter” key.
Rechanging
The ventilator will
change the
normal ventilation
mode.
Only physicians and competent nursing, technical staff are permitted to access the clinical
screens. The patient must never be told how to access these screens.
MTV1000 allows you to save one set of ventilation parameters. From the main clinical screen
you can modify the M1 ventilation mode. When you have entered a program you can make
the desired modifications. There modification is automatically saved when you exit the clinical
setting menu.
B
Selecting a
A. Select M1 ventilation
ventilation
1 program.
program to
B. Select “Setting” Button.
setup
B
C. Select Patient type.
Selecting
D. Input patient height with
2 Patient type
encoder.
& Height
E. Push “Next” Button.
A C
F. Setup M1 ventilation
Program value.
3 Ventilation G. And push “SAVE” button
Value will save M1 ventilation
A value.
6.1.1. Encoder
Spin the encoder on key panel to select wanted menu or configure wanted setting value.
Click the encoder button to select sub menu or save setting value.
Turn Left
Turn Right
-Descend menu
-Elevate menu
-Decrease setting value
-Increase setting value
Click
Select menu, save setting value
CAUTION
Once alarm occurs in the device, red light blinking. This light is kept on until user pushed
“RESET” button even after the condition is removed.
2 Alarm 2 Min Auditory alarm signal is not created for two minutes.
CAUTION
If “AC Power ON LED” and “Battery ON LED” are both OFF, internal battery has run out.
NOTE
For more details on the mode, refer to Appendix.1 Ventilation Mode Specification
NOTE
For more details on the mode, refer to Appendix.1 Ventilation Mode Specification
Measurement
Information
Wave Graphs
Alarm
Messages
The most important thing in deciding Exhalation time is whether sufficient exhalation has
taken place. If Exhalation time is too short, higher residual pressure called as Self PEEP (or
Auto PEEP) than PEEP pressure remains.
If the flow rate at the end of expiration is zero, then it means that lung pressure is enough
lowered down to PEEP pressure.
It means that the reference lung pressure at the end of exhalation is higher than PEEP. The
cause is short exhalation time.
In mandatory ventilation, if E_flow is not zero, Exhalation time is short and Self PEEP
exists, therefore you must lower the respiratory rate to use it.
On the other hand, if the respiratory rate is increased then you must check that E_flow is
zero after you increase the respiratory rate.
Upper figure : It is sufficient exhalation time and lung pressure is the same as PEEP and
E_flow is zero.
Lower figure : It is insufficient exhalation time and lung pressure is higher than PEEP and
E_flow is not zero.
Item Description
Item Description
Item Description
Events relating to changes in ventilation mode and parameter setting
Setting
are displayed
Alarm Events relating to alarm are displayed
6.11.1. SETUP
*BTPS is an abbreviation of "Body Temperature and Pressure Saturated with Water Vapor" and
refers to the state in which physical factors that influence volume inside body are taken into
consideration. This function compensates for volume of air supplied, considering difference
between body temperature and external temperature with altitude above sea level.
6.11.2. DATE
Item Description
CAUTION
When performing O2 calibration, both 21% and 100% must be carried out.
CAUTION
Before performing Exhalation Flow Auto calibration, inspiration port and expiration port
must be connected to tube.
Item Description
BED NUMBER Designate patient’s bed number.
ID Input patient’s ID number.
IP Input IP address for external connection using LAN.
PORT Input port number for external connection using LAN.
SVC Code Configure password for IP and port input.
When user attempts to enter a number, the following keyboard appears on the screen.
Touch-Key
Lock
Trigger sensitivity determines the patient’s effort during breath to induce ventilation from
ventilator.
Pressure trigger is configurable within the range of 0.5 ~ 20 cmH2O (pressure trigger
setting is also related to PEEP setting).
Flow trigger refers to the amount of bias flow that must be inhaled by the patient to induce
new breath.
WARNING
The trigger sensitivity bar has different colors based on the setting. A light blue bar
indicates a normal setting for flow. A red bar indicates that triggering is required for flow.
The ventilator continuously delivers a gas flow during expiration, which is measured in the
expiratory channel.
1. Inspiration
Bias flow during expiration is 8 l/min.
WARNING
If the trigger sensitivity is set too high, a self triggering(auto-triggering) condition may be
reached. This condition can also be reached if there is leakage in the breathing system.
Triggering will then be initiated by the system and not by the patient. This should always
be avoided by decreasing the trigger sensitivity.
(Time adjustment from starting point of inspiration to time of peak flow or peak pressure)
The arrival time to peak flow or peak pressure is adjustable to second or percent of
respiratory cycle at the starting point of inspiration for each breath. If rise time is high,
increased flow/pressure and it is displayed through flow and pressure waveforms
In general, configured rise time must be higher than default system value in order to
deliver comfortable ventilation to the patient in support mode.
7.1.5. PEEP
Setting range of Positive End Expiratory Pressure (PEEP) is 0 ~ 50cmH2O. PEEP is
maintained in the alveoli and may prevent the collapse of the airways.
Once inspiration time is configured in the ventilator, pause time and inspiratory rise time
are automatically changed. Change in I:E ratio according to inspiration time and pause
time is displayed in information window on the bottom right corner of user interface.
7.1.9. O2 Cencentration
The setting range of O2 concentration is 21 ~ 100%.
There is also an absolute minimum limit of alarm is 18% O 2 which is independent of
operating setting. If the value reaches below this point, O2 fail alarm will sound.
The screen only displays O2 concentration of 21% or higher. The alarm is delayed 60
seconds after changing the O2 concentration setting.
7.1.13. En_Sense
The EnSense means Inhalation-Trigger Enable Sensitivity. It is the function for next
inhalation trigger is triggered only when a certain volume exhalation must be taken place
proportionally to the inhalation volume.
If this function is used, it allows trigger of the patient and can restrict or prevent retrigger
phenomena and mandatory breathing can be successfully maintained.
7.1.14. Ex_Sense
It reduces patient’s expiring effort compared to the pressure detection mode in the past
and has equipment responses rapidly to the effort of the patient.
Expiration can be taken place only when it exceeds the target pressure after patient
finishes to inhalation. In this case, response speed is late and it needs patient’s effort.
The mechanic characteristic in PSV is not same in each ventilator. The Ex_Sense[%] is to
be decided by individual condition of patients.
If the patient doesn’t have enough spontaneous respiratory capacity, then inhalation must
be sufficiently taken place. Therefore Ex_Sense must be decreased.
Volume control mode is based on mechanical ventilation method and the ventilator
delivers configured tidal volume to the patient.
VACV mode is a mode that controls mechanical ventilation of the patient based on air
volume. It controls inspiratory and expiratory times by force
NOTE
Default value is configured in proportion to body weight of the patient.
The airway pressure is dependent on the tidal volume, inspiration time and the resistance
and compliance of the respiratory system. The set tidal volume will always be delivered.
An increase in the resistance and decrease in compliance will lead to an increased airway
pressure. To protect the patient’s lungs from excessive pressure, it is very important to
set the upper pressure limit to a suitable value.
Inspiratory Inspiratory
Time Time
It is possible for the patient to trigger extra breaths if they can overcome the pre-set
trigger sensitivity. It is also possible for the patient, by their own inspiratory efforts, to
receive a higher inspiratory flow and Tidal Volume during an inspiration than pre-set.
During volume control ventilation, peak flow is determined after configuration of tidal
volume and inspiratory time. Also in addition to the above two items, end flow and
plateau are items that influence peak flow.
Volume Control assures a preset tidal volume with constant flow during a preset
inspiratory time at a preset frequency.
When the preset tidal volume is delivered and after the preset pause time.
When changing setting values of I:E ratio or items that influence inspiratory time, breath
timing bar is displayed to show changes in cycle time, inspiratory time, expiratory time
and I:E ratio.
The spontaneous/pressure supported breaths are defined by the setting for Pressure
Support.
WARNING
Mechanical ventilation is paralleled based on volume according to spontaneous ventilation
or in case of no spontaneous ventilation based on time period configured.
SIMV mode is a mode in which Mandatory Breath and Spontaneous Breath are mixed.
SIMV mode guarantees one mandatory breath per SIMV cycle. This mandatory breath is
either patient initiated mandatory (PIM or assisted mandatory) breath or ventilator
initiated mandatory (VIM or controlled mandatory) breath.
As in the figure below, each SIMV breath cycle is divided into two parts. One is
Mandatory Interval (Tm) and another is Spontaneous Interval (Ts). Once PIM breath is
delivered, mandatory interval ends and spontaneous interval (Ts) begins.
If PIM breath does not occur until mandatory interval ends, VIM breath is provided to the
patient as soon as mandatory interval ends and spontaneous interval begins.
NOTE
Default value is configured proportional to body weight of the patient.
When providing pressure control ventilation using mandatory breath in A/C mode,
configure Inspiratory Pressure.
Since pressure is maintained constant during inspiration, flow pattern is in ramp form,
and Plateau function cannot be used.
Since exhalation valve is active exhalation valve, Airway Pressure control becomes more
active and precise. Therefore, increase in pressure caused when the patient talks or
coughs during inspiration can be controlled using exhalation valve. Spontaneous
ventilation by the patient is also allowed.
The delivered volume is dependent upon the pressure above PEEP, lung compliance and
resistance in the patient tube system and airways. This means that the Tidal Volume can
vary.
As the delivered tidal volume can vary it is very important to set alarm limits for Minute
Volume to adequate levels.
Inspiratory Inspiratory
Time Time
Pressure Control assures that the preset inspiratory pressure level is maintained
constantly during the entire inspiration.
The preset pressure level is controlled by the ventilator. The resulting volume depends on
the set pressure level, inspiration time and the patient’s lung mechanical properties
during each breath.
Since exhalation valve is active exhalation valve, airway pressure control becomes more
active and precise. Accordingly, exhalation valve is used to control increase in pressure
caused by talking or coughing of the patient during inspiration. It also allows the patient
to spontaneously breathe.
If the pressure increases to the set upper pressure limit, the expiratory valve opens and
the ventilator switches to expiration.
The spontaneous/pressure supported breaths are defined by the setting for Pressure
Support.
WARNING
Mechanical ventilation is paralleled based on volume according to spontaneous ventilation
or in case there is no spontaneous ventilation using configured time period.
SIMV mode is a mode in which Mandatory Breath and Spontaneous Breath are mixed.
SIMV mode guarantees one mandatory breath per SIMV cycle. This mandatory breath is
either patient initiated mandatory (PIM or assisted mandatory) breath or ventilator
initiated mandatory (VIM or controlled mandatory) breath.
As in the figure below, each SIMV breath cycle is divided into two parts. One is
Mandatory Interval ™ and another is Spontaneous Interval (Ts). After delivery of PIM
breath, Mandatory Interval ends and Spontaneous Interval (Ts) begins.
If PIM breath does not occur until the end of Mandatory Interval, VIM breath is provided
to the patient as soon as Mandatory Interval ends and Spontaneous Interval begins.
Pressure Regulated Volume Control (PRVC) is a mechanical ventilation mode based on auto
pressure control. Constant volume is maintained through target volume and pressure limit
setting.
The ventilator delivers a pre-set Tidal Volume. The pressure is automatically regulated to
deliver the pre-set volume but limited to 1 cmH2O below the set pressure limit.
PRVC assures a set target minute ventilation to the patient. The target volume is based
upon settings for Tidal Volume, frequency and inspiration time.
The inspiratory pressure level is constant during each breath, but automatically adapts in
small increments breath-by-breath to match the patient’s lung mechanical properties for
target volume delivery.
The ventilator delivers configured tidal volume. Pressure maintained for supply of
configured tidal volume is automatically adjusted within the range of pressure limit.
The first breath of a start sequence is a volume-controlled test breath with pressure of
16cmH2O. The measured pause pressure of this breath is then used as the pressure level
for the following breath.
WARNING
If spontaneous ventilation is not detected for configured time while operating in this mode,
mode is automatically converted to the mode (V-ACV or P-ACV) configured in Apnea
Backup.
WARNING
Mode returns to Spontaneous ventilation mode once the patient breathes twice by
themselves.
Once the patient’s intention for spontaneous ventilation reaches sensitivity, flow is
provided to the patient. Pressure is maintained between sensitivity setting value and
pressure level 1 cmH2O below sensitivity setting.
Once pressure becomes 1 cmH2O larger than PEEP, exhalation valve is opened to begin
expiration.
If the patient falls into apnea during SPONT mode, Apnea Alarm goes off by itself and
Apnea Ventilation (V-ACV Mode or P-ACV Mode) is automatically started. This Apnea
Ventilation is operated according to items configured by user and the Respiratory rate is
automatically changed to 15 RPM.
The mode returns to Spontaneous Mode if the patient shows two spontaneous breaths in
10 seconds.
V-ACV or P-ACV mode is selected for operation. This mode can be operated with
simplicity and stability during emergency. All settings are automatically configured and
mode can be operated as soon as body weight is entered.
NOTE
If you use the Oxygen gas of low flow through the Flowmeter, the effect of oxygenation may be
negligible according to High flow.
▣ Standard Accessories
V-ACV O O O O O O O O O O
V-SIMV O O O O O O O O O O
SPONT O X O O O X O O X X
P-ACV O O O O O O O O O O
P-SIMV O O O O O O O O O O
PRVC O O O O O O O O O O
AUTO O O O O O O O O O O
WARNING
SpO2 extension cable connector is in bright silver color. EtCO2 extension cable connector is
in black color.
Be careful not to confuse between them when connecting cables.
Sensor can be damaged by incorrect connection. Please contact customer service team if
the sensor functions improperly after mistaking between two connectors.
Oxygen saturation concentration shows the degree of saturation of hemoglobin that can
transport oxygen in the artery. That is, it displays the degree of currently transported
amount compared to oxygen transport by hemoglobin as a percentage.
WARNING
Use only SpO2 sensor certified by MEKICS. Otherwise, it may cause problems in
performance.
Incorrect methods such as tight fixation of sensor using fixing tape can harm the patient
on skin tissues.
Sensor should not be used on parts with artery catheter or vein syringe.
Do not use damaged SpO2 sensor or optical device.
Since the sensor is not waterproof, do not place in water and solvent or clean excessively.
Do not sterilize the sensor with ultraviolet ray, direct sunlight, steam or hydrogen
peroxide.
CAUTION
Do not use the sensor to patients with allergic symptoms to SpO2 sensor.
Do not use SpO2 sensor during MRI screening because there is risk of sensor burning.
Immediately remove the sensor if the patient calls for discomfort.
ATTENTION
Inaccurate values and waves can result if sensor is used incorrectly as below.
▣ When sensor not certified by MEKICS is used or sensor is used incorrectly
▣ Functional disorder in hemoglobin
▣ When sensor is excessively exposed to medical light (especially xenon light), bilirubin
light, fluorescent light, infrared heating device, or direct sunlight
▣ Excessive movement by the patient
▣ Use of high frequency electric surgical instrument or cardiac resuscitator
▣ When pulse of venous blood measured at a spot where blood pressure is measured,
pressure bandage is used, artery catheter is used, or sensor is used inside blood vessel
▣ When the patient shows symptoms of hypotension, severe blood vessel contraction,
severe anemia or hypothermia
▣ When there is arterial occlusion nearby the sensor
▣ When the patient is experiencing cardiac arrest or shock
EtCO2 sensor displays CO2 concentration of the patient towards the end of inspiration as
a graph.
The IRMA CO2 main stream CO2 probe is intended to be connected to other medical
devices for display of real time and derived monitoring data of CO2.
It shall always be used in combination with other vital signs monitoring devices and/or
professional human judgments of patient condition. The IRMA probe is intended to be
used by trained and authorized health care professionals only.
1 2 3 4 1
Stage Description
Initial stage of expiration in which gas inside anatomical dead space with almost no
1~2
carbon gas is discharged
Stage in which gas from pulmonary alveoli and gas inside anatomical dead space are
2~3
mixed and discharged
3~4 Stage in which gas from pulmonary alveoli is discharged
4 Partial pressure (concentration) of carbon dioxide towards the end of expiration
4~1 Inspiration
1) Setup Connection
A. Connect the IRMA analyzer interface cable to the “Gas Extension cable”.
Snap the IRMA probe on top of a new IRMA airway adapter. It will click into
place when properly seated.
Unless the IRMA probe is protected with an HME always position the IRMA
probe with the status LED pointing upwards.
II. If, for whatever the reason, the IRMA probe is in direct contact with any
parts of the infant's body an insulation material shall be placed between the
IRMA probe and the body.
WARNING
▣ The IRMA probe is intended for use by authorized and trained medical personnel only.
▣ The IRMA probe must not be used with flammable anesthetic agents.
▣ Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter
can cause cross infection.
▣ Used airway adapters shall be disposed of in accordance with local regulations for
medical waste.
▣ Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6
ml dead space to the patient circuit.
▣ Do not use the IRMA Infant airway adapter with adults as this may cause excessive
flow resistance.
▣ Measurements can be affected by mobile and RF communications equipment. It should
be assured that the IRMA probe is used in the electromagnetic environment specified
in this manual.
▣ Do not place the IRMA airway adapter between the endotracheal tube and an elbow as
this may allow patient secretions to block the adapter windows and result in incorrect
operation.
▣ Do not use the IRMA airway adapter with metered dose inhalers or nebulized
medications as this may affect the light transmission of the airway adapter windows.
▣ The IRMA probe is intended only as an adjunct in patient assessment. It must be used
in conjunction with other assessments of clinical signs and symptoms.
▣ Incorrect probe zeroing will result in false gas readings.
▣ Replace the adapter if rainout/condensation occurs inside the airway adapter.
▣ Use only PHASEIN manufactured IRMA airway adapters.
▣ The IRMA probe is not intended to be in patient contact.
▣ Only use CO2 components certified by MEKICS.
CAUTION
▣ Never sterilize or immerse the IRMA probe in liquid.
▣ Do not apply tension to the probe cable.
▣ Do not operate the IRMA probe outside the specified operating temperature
environment.
▣ Federal law restricts this device to sale by or on the order of a physician. (U.S.)
▣ The IRMA Airway Adapters are non-sterile devices. Do not autoclave the adapters as
this will damage them.
The MTV1000 is intended for use in the electromagnetic environment specified below. The
customer or the user of the MTV1000 should assure that it is used in such an environment.
RF emissions
Class A
CISPR 11
The MTV1000 is suitable for use in all
Harmonic emissions establishments, including domestic establishments
Class A
IEC 61000-3-2 and those directly connected to the public low-
voltage power supply network that supplies
Voltage fluctuations / buildings used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3
The MTV1000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MTV1000 should assure that it is used in such an
environment.
IEC 60601 Compliance Electromagnetic environment
Immunity test
Test level level -guidance
Floors should be wood, concrete
Electrostatic
± 6 kV Contact ± 6 kV Contact or ceramic tile. If floors are
discharge (ESD)
covered with synthetic material,
± 8 kV air ± 8 kV air the relative humidity should be at
IEC 61000-4-2
least 30 %.
± 2 kV for power ± 2 kV for power
Electrical fast
supply lines supply lines Mains power quality should be
transient/burst
±1 kV for ±1 kV for that of a typical commercial or
input/output lines input/output lines hospital environment.
IEC 61000-4-4
± 1 kV differential ± 1 kV differential
Surge Mains power quality should be
mode mode
that of a typical commercial or
± 2 kV common ± 2 kV common
IEC 61000-4-5 hospital environment.
mode mode
NOTE Uт is the a.c. mains voltage prior to application of the test level.
The MTV1000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MTV1000 should assure that it is used in such an
environment.
NOTE 1 ) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the EUT is used exceeds the applicable RF compliance
level above, the EUT should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
MTV1000.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than [V 1] V / m.
C. Warranty period for this product is regulated as two year since installation.
However, warranty period for LCD, battery and O2 cell is six months.
D. If the product shows defects under normal use during warranty period, our customer
service team will repair defects free of charge during warranty period.
E. Prescribed service fees are levied after repair in the following cases.
▣ Defect from natural disasters such as fire, earthquake and lightning
▣ Defect from inappropriate movement or carelessness in use of the product after
installation
▣ Defect from repair or renovation made by an individual other than service agents
designated by MEKICS
CAUTION
If defect is caused by inappropriate handling or careless management of the product, the
manufacturer and its sales agencies are not responsible for any damages.
Contact us
For more information in detail, contact us to the following numbers and addresses.
We are also receiving customer complaints through MEK ICS web site. If you experience
any discomforts or improvements to be made on the product, please feel free to contact
our company or its customer service team at any time.