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CV001 - Ventilator - MEK ICS - MV2000 - EVO5 - Users Manual
CV001 - Ventilator - MEK ICS - MV2000 - EVO5 - Users Manual
This User Manual may be revised for the improvement of the product, without prior notification.
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User’s Manual
This User’s Manual is provided to users with MV2000 Ventilator product.
URL: http://www.mek-ics.com
Notice
This document includes exclusive information protected by copyright. Under the copyright law,
prohibits unauthorized copying and modification of the document without prior approval.
Warranty
Contents in the publication are subject to change without notice.
MEKICS takes no responsibility for any problems and damages caused by performance or different
data from the other than detailed in this document
Revision History
Part and revision numbers in this document represent current version.
The revision number does not change even if subordinate documents are modified or
supplemented.
The revision number is only changed in case of change in part numbers or technical matters.
i. Device Illustration................................................................................................................................. 11
v. Environment ............................................................................................................................................. 12
i. Summary .................................................................................................................................................... 13
6.2.2. Detaching and disassemble the Exhalation Valve Assembly ....................... 123
i. Device Illustration
① ①
② ②
iii. Usage
1. Intended use
This ventilator makes the patient who has impossibility or shortage of spontaneous
respiratory have a respiratory volume. Additionally, it has function to adjust
suitable O2 ratio and alarm for safety of patient.
2. Intended application
MV2000 is a device for ventilation in ICU, Operating Room, CCU and Emergency Room. It
delivers room air or oxygen-enriched gas into the breathing circuit, where it can be humidified
by a heated humidifier or a heat and moisture exchanger before delivery to the patient. They
provide long-term support for patients who do not require complex critical care ventilators
MV2000 is intended for “in-patient use” in hospital, Medically-used rooms for neonatal to Adult.
* Age / Weight: All
* Gender: male and female
* Healthy: N/A
* Nationality: Multiple
v. Environment
MV2000 ventilator must be used in the following environments.
- Hospitals
- Facilities and institutions with the purpose of providing medical service
- Transportation of patients within hospitals or medical institutions
CAUTION
- Regular Inspection
MV2000 ventilator must be regularly inspected by a trained professional.
- Inspection Record
All matters related to inspection of MV2000 ventilator shall be recorded in
accordance to regulations by hospital, local government, and national government.
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
NOTE
Notes provide additional guidelines or information.
i. Summary
This booklet summarizes functions and characteristics of the MV2000 ventilator
system. Since not all details of MV2000 are included in this booklet, do not use this
booklet as a document for training.
WARNING
Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich
environment accelerates combustibility.
WARNING
- Always perform pre-checking prior to connecting the ventilator to a patient.
- In case of the following, stop the use of ventilator and contact service assistant.
→ If unordinary screen shows up
→ If an alarm cannot be settled
→ If the device creates abnormal sound
→ If the device is operating abnormally or shows unexpected failure
- The ventilator must always be maintained vertical during use.
- If the ventilator is connected to a patient,
→ Carefully monitor the patient.
→ Prepare for reserve ventilators for easier use.
→ Do not raise or separate expiratory part.
→ Always check setting and measurement values displayed on the screen.
- MV2000 ventilator must be operated by an experienced user in accordance to
guidelines given in this booklet.
- Manual Resuscitator must be prepared for immediate use in case of failure of ventilator
during use. Without an alternative means of ventilator, it can lead to patient death.
- Do not cover the ventilator in any way. This may cause errors in its functions.
- Expiratory part of the ventilator and expiratory may be contaminated.
ii. Cautions for Storage
WARNING
5) Do not store the product in a very humid place or in a place with poor
ventilation.
7) Do not store the product in a place where the product could be exposed
to chemicals or explosive gases.
10) Turn off the product when you will not be using the product for a while.
WARNING
Do not use an HME together with a medication nebulizer or breathing gas humidifier. This
can lead to a greater breathing resistance.
WARNING
1) With nebulizer using a pneumatic medication nebulizer, the deviation may amount
to up to 2cmH2O.
2) It may not be possible to detect the leakage in the breathing circuit
3) In particular, if you use an exhalation filter, you will need to monitor it frequently
because it can increase resistance and adversely affect ventilation
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 of 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) Use only accessories on the essential performance certified by MEKICS.
Otherwise, it may cause problems in performance. If you use the accessories of
non-certified by MEKISC, it may cause degraded performance.
NOTE
When using non-invasive ventilation (NIV), the patient’s actual exhaled volume may differ
from the exhaled volume reported the ventilator due to leaks around the mask.
A ventilator intended for non-invasive ventilation is either optionally equipped with CO 2
monitoring equipment for the measurement of expiratory carbon dioxide concentration in
accordance with ISO 80601-2-55.
CAUTION
Only use auxiliary equipment provided by the MEKICS Head Office or MEKICS’ designated
representatives.
CAUTION
This product uses 12VDC / 7Ah lead (Pb) battery.
When charging battery, connect the AC cable. Take care to prevent metal substances
from contacting the battery charging terminal.
v. Cautions for Electronic Safety
This product acquired electronic safety standard, CLASS A.
WARNING
To avoid a fire hazard, keep all components of the system away from all sources of ignition
(such as matches, lighted cigarettes, flammable medical gases, and/or heaters). Oxygen-
rich environments accelerate combustibility.
WARNING
In case of fire or a burning smell, immediately take the following actions if it is safe to do
so: disconnect the patient from the ventilator and disconnect the ventilator from the
oxygen supply, facility power, and all batteries. Provide alternate method of ventilatory
support to the patient, if required.
WARNING
WARNING
To minimize fire hazard, inspect and clean or replace, as necessary, any damaged ventilator
parts that come into contact with oxygen.
WARNING
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or
electrically conductive hoses or tubing in or near the ventilator breathing system.
x. Warnings Regarding Infection Control
WARNING
Patients receiving mechanical ventilation may experience increased vulnerability to the risk
of infection. Dirty or contaminated equipment is a potential source of infection. It is
recognized that cleaning, sanitation, and disinfection practices vary widely among health
care institutions. Always follow your hospital infection control guidelines for handling
infectious material. Follow the instructions in this manual and your institution’s protocol
for cleaning and sterilizing the ventilator and its components. Use all cleaning solutions
and products with caution. Follow manufacturer’s instructions for individual cleaning
solutions. Reference Chapter 6 of this manual.
WARNING
To prevent infection and contamination, always (must) use the bacterial filter in
the inspiratory port at ventilator before use to patient.
WARNING
Never attempt to re-use the single use patient components or disposable
accessories. Doing so, increases risk of cross-contamination and re-processed of
single use patient components or disposable accessories are may degraded its own
function, and, leading to possible degraded performance of the mechanical
ventilation.
Use no hook
This side up
Keep dry
Fragile
Recovery/recyclable
Serial number
Carton number
Non-Invasive Ventilation
To perform non-invasive artificial ventilation, you must turn on the Leak
Compensation MASK ("Leak compensation") in the settings window.
NOTE
In order to perform noninvasive ventilation, it is important to fix the mask. Do not use
a mask with a leak hole (vented mask). If leakage flow is large around the mask, the
patient's triggering is not detected an alarm may occur.
- Functional goal
Under leakage flow, the leak compensated function will minimize asynchrony by
sensing stable patient trigger as possible.
Under leakage flow, the leak compensated function will support to be accuracy
patient volume measuring.
This function provides leak flow as useful information for patient care. Under leak
flow, the device will provide accuracy patient flow and volume as possible.
- Principle
Definition
F_pat: Patient’s flow
F_ins: Inspiratory flow
F_exp: Expiratory Flow
F_leak: Leak Flow
Paw: Airway Pressure
Vt_ins: Inspiratory tidal volume
Vt_exp: Exhaled tidal volume
Vt_pat: Tidal Patient volume
Vt_leak: Leak Tidal volume
The system got the formula between F_leak and Paw from patient breathing or
ventilation.
And the ‘leak-compensation’ of system will be operated by following formulas.
Applied this formula bring to stable synchrony and accuracy flow and volume measuring.
WARNING:
Use the patient circuit with the lowest possible compliance in the ventilator to
ensure optimal patient circuit compliance and deliver accurate volume.
Note:
When operating in volume controlled mode, circuit compensation can deliver high peak
pressure when using a newborn patient circuit. For this reason, when applying to a
newborn patient, it is recommended to set the Tube compensation to OFF in the System
menu and use the Proximal sensor.
WARNING
Activating of ET tube (Artificial Airway) Compensation while ventilating a
patient will cause a sudden increase in the peak airway pressures and a
resultant increase in tidal volume. If you choose to activate ET tube
(Artificial Airway) Compensation while the patient is attached to the
ventilator you will need to exercise caution to minimize the risk of excessive
tidal volume delivery.
NOTE
Monitored airway pressures (inspiratory) will be higher than set values when ET tube
(Artificial Airway) Compensation is active.
Humidification
You can select "ATPD" or "BTPS" depending on the type of humidifier you want to use
(ON / BTPS or OFF / ATPD). Generally, if you use a humidifier, select "BTPS"
(humidification assumes 99% RH) and select "ATPD" (assumes 60% RH) only if you
choose another humidification method such as HME. This function is for measuring the
respiratory volume accurately, reflecting the temperature and humidity of the gas. This
function can be changed in the BTPS setting in the SYSTEM column of the setting
window.
Range: Off/On
Default: Active (ON)
NOTE
If incorrect selected, the error rate of the measurement value in expiratory
volume may become large.
WARNING
Selection of the incorrect humidifier type (BTPS) and/or volume during 'Circuit
Check' or during patient ventilation can affect the accuracy of delivered volume
to the patient by allowing the ventilator to incorrectly calculate the compliance
correction factor used during breathe delivery. This can be a problem, as the
additional volume required for circuit compressibility compensation could be
incorrectly calculated, resulting in over- or under-delivery of desired volume.
- Principle
BTPS(Body Temperature Pressure Saturated) and APS (Ambient Pressure
Saturated) is the compensation with the information of Body temperature (37℃),
humidity (100% relative humidity) and Ambient Pressure to deliver the same
volume as setting value to patient’s lung.
Definition
PVAP: Vapor pressure
Cf_Temp: Conversion factor of temperature saturated
Cf_Vapor: Conversion factor of vaporized pressure (Humidity) saturated
Pamb: Ambient pressure ( Atmosphere pressure )
T_Ins: Inspiratory Gas temperature
T_exp: Expiratory Gas temperature
Pvapor_Ins: Vapor pressure of Inspiratory Gas
Pvapor_Exp: Vapor pressure of Expiratory Gas
Table 2.1 Ventilator main body outside Label or Panel Symbols and Descriptions
Symbol Description
Ground
WARNING
The ventilator can be connected to oxygen cylinder. O2 supply pressure ranges must be
between 241 kPa and 620 kPa (35 and 90 psi) and the average flow will not exceed 60
L/min at 280kPa. The transient flow will not exceed 160 L/min for ≥ three(3) seconds.
WARNING
The ventilator should be connected to a gas pipeline system compliant to ISO 7396-1
because:
- Installation of the ventilator on a non-ISO 7396-1 compliant gas pipeline system may exceed the
pipeline design flow capacity.
- The ventilator is a high-flow device and can interfere with the operation of other equipment using the
same gas source if the gas pipeline system is not compliant to ISO 7396-1.
CAUTION
The weight of the ventilator main body is approx. 50 kg. Be careful when installing.
2.1.6 User interface connection method
Attach the latch of the connection bundle to the retainer and secure it with the
screw at the center. Connect and fasten the connector as shown in the figure.
Turn the water bottle to the right to insert it to the Exhalation Valve block as
shown figure 2.3.
Insert the valve membrane and flow sensor as shown figure 2.4.
Connect the Exhalation Block to the front of the ventilator as shown below. At
this time, a click sound is heard. To remove it, pull the lock handle to the left
and pull out the exhalation valve block to remove it.
A5
A3 A4 A6 A7
CAUTION
A change in the flow rate due to the use of this nebulizer may affect the patient's tidal
volume.
① MV2000 connect the EtCO2 sensor cable to the socket labeled EtCO2 on the
right side of the ventilator
④ When the green LED on the IRMA probe is displayed, it is ready for use.
Or, HME (Heat Moisture Exchanger) between patient endotracheal tube and IRMA
probe. It does not need to change airway adapter discharge, water vapor effect
and adapter in front of HME and protect IRMA probe. Free positioning of IRMA
probes is also possible.
Unless the IRMA probe is protected with an HME always position the IRMA probe
with the status LED pointing upwards.
NOTE
See chapter * for placement technique for esophageal balloons.
NOTE
See chapter * for placement technique for esophageal balloons.
Table 2.3 User Interface Rear Label or Panel Symbols and Descriptions
Symbol Description
Manufacturing date
WARNING
The MP601(Central Monitoring System) with LAN connection port is to be operated by
clinical physicians or appropriate medical staffs under the direction of physicians. The
operator of the MP601 must be well trained. Any operation by unauthorized or non-trained
personnel is forbidden.
①
36Pin connector
②
OTG USB Port
④
③ 10/100 MB LAN
HOST USB Port
18
36 1
19
5 6
⑥ HDMI Port
This port is an HDMI connector and is used to connect a large monitor to the outside
separately.
However, the functionality is not implemented at this time.
B9 B8
B2 B3 B4
B5 B6
B1
B7
B10
B11
NOTE
The ventilation system does not contains latex.
The setting window consists of SYSTEM menu for setting ventilator operating
environment, Patient menu for setting patient information, Date menu for setting date
and time, and Cal. menu for calibrating.
A. Oxygen(O2) Cell
- It is used to turn on / off the oxygen concentration alarm function. It is used to
temporarily stop the alarm function when the oxygen concentration sensor is broken
in use to the patient. It is always ‘On’ status.
- Press once to turn on (Enable), press once again to turn off (Disable).
- Set O2 cell on / off.
- ENABLE: Set when O2 GAS is used and O2 cell is normal.
- DISABLE: Set when there is no O2 GAS, O2 cell is dead, or O2 cell is not available for
other reasons. O2 GAS supply is not affected.
WARNING
For patient safety, it is recommended to monitor the oxygen concentration supplied to
the patient by connecting another Oxygen Monitor even when if this function is turned
off when the oxygen sensor fails.
B. O2 Boost Adult
Set O2 concentration of adult when using O2 Boost function. When this key is pressed,
the ventilator increases the oxygen concentration delivered to the patient for 3 minutes.
If the ↑ %O2 key is pressed again within this two-minute period, the maneuver is
cancelled and the ventilator will return to prior settings.
Defaults: 79% Adult/Pediatric
Adult/Pediatric: 79% above the set % O2
D. Nebulizer Type
- Pneumatic: Operates with internal pneumatic source.
- Micro Pump: Operates with Micro Pump of Aerogen (option)
E. Nebulizer Time
- Set the Nebulizer usage time.
- Setting range: 10 ~ 180 minutes
F. BWF
- When using PBW, the tidal volume is determined according to the Predicted Body
Weight formula based on the height and gender of the selected patient, and the default
setting is 8 ml / kg.
- Set volume (mL) per 1 kg of patient's weight (B / W).
- Setting range: 1 ~ 15 mL / kg
- Connect the blue tube to the left connector of the above figure.
H. BTPS
- BTPS is an abbreviation of "Body Temperature and Pressure Saturated with Water
Vapor", which means the physical factors that may affect the volume of gas in the
body. It is a function to compensate the volume of supplied air considering the
difference between the air temperature and outside temperature of the patient and
the altitude of the sea.
- Setting range
OFF: Turns off the BTPS function.
J. ET Tube Diameter
- Enter the tube diameter for ET tube compensation.
K. ET Tube Length
- Enter the tube length for ET tube compensation.
M. Leak Compen.
- Select to Non-Invasive Ventilation for use.
- In order to perform non-invasive artificial ventilation, you need to turn on leakage
compensation function "Leak compensation" in setting window.
- Even if you do not use non-invasive ventilation, you should turn on this function and
use this function for when if use the leak compensation.
N. Wave Style
- Line, Gradation
- Sets the representation of the waveform
O. Graph sp
- Sets the speed of the graphic waveforms.
- Settings: x1, x2, x4, x8, x16
P. CO2 Unit
Q. Language
- Set the device user language.
- English is the default. In addition, Russia, Spanish, Chinese, Italian, Turkish, Polish,
Korean are supported.
R. Sound Vol.
- Determines the ventilator's alarm sound volume.
- Setting range: 10 ~ 100%
S. Date, time
- Set the date and time.
T. Trend Init
- Initializes trend data.
Enters patient information in patient menu and sets the following parameters. For
details, refer to Chapter 3 Operation instruction.
A. BED Num
- Specify the patient bed number.
B. ID
- Enter the patient's ID number.
C. SVC Code
- Set the password (0077) for data information in the IP and port.
D. IP
- IP address for communication (external connection using LAN)
F. System information
- Information on Main and Pneumatic SW Version, ventilator working time, O2 remaining
amount.
CAUTION
All procedures should be performed on the ventilator after separation from the patient.
CAUTION
All calibrations should be calibrated and checked at least once a month when the patient
changes or the patient circuit changes.
4. Exit
After initial operation, the following window will appear on the screen after INS-
EXP calibration. Adjustment is required if the initial operation or patient circuit
changes.
After initial operation, the following window will appear on the screen. Adjustment
is required if the initial operation or exhalation valve assembly changes.
NOTE
If the oxygen (O2) cell has reached its end of life, perform cell (O2) cell calibration after
replacing the cell.
CAUTION
MV2000 Ventilator is equipped with O2 monitoring function, but O2 monitor should be
provided for accurate oxygen concentration measurement.
2.7.1 Outline
MV2000 ventilator has auto transition function for rated voltage. The ventilator
automatically adjusts to 100-230 VAC power.
NOTE
Battery can’t be replaced, during the use of ventilator.
Internal battery
Recharge able battery - 12VDC, 7Ah.
When the ventilator is operated using battery, remaining operation time of the
battery is displayed on the bottom right corner of the screen.
When battery state is low, battery icon on the bottom right is displayed in red
color. Here, battery should be replaced or, if possible, connect the ventilator to
main power source.
WARNING
- Check the battery prior to use for safe battery backup operation.
- If low battery is displayed, battery must be quickly replaced.
- Long-term storage may cause reduction in battery capacity. Do not leave battery
module unattached or stored for long time. If it is necessary to store a battery for
short time, fully charge the battery and store at low temperature (15-20℃or 59-68℉)
under dry environment.
- Stored or unused battery must be charged before using.
- Disposed batteries must be handled in accordance to local regulations. Do not discard
them with ordinary wastes.
- After replacing with new battery, check the status of new battery for safe operation.
- Battery may not be fully charged upon initial supply of the product. Use user interface
to check charging status. If necessary, connect the ventilator to main power source to
charge the battery prior to use.
- Discharged battery must always be charged for use.
When the ventilator is not in use, it must always be connected to main power source
to charge the battery.
A. Check of pre-use
B. Select the patient type.
C. Input patient information in the system menu.
D. Select ventilation mode.
E. Configure parameters for the selected ventilation mode.
F. If necessary, check and adjust alarm range in the alarm menu.
G. Connect the ventilator to the patient and push Accept button in ventilation
mode to start ventilation.
H. During ventilation, user can make or change the settings as below.
I. Parameter setting can be seen or changed using direct access button.
WARNING
1. Always perform pre-use check prior to connecting the ventilator to the patient.
2. Do not connect the ventilator to the patient if it has functional errors.
3. When ventilator is in operation, do not raise or separate expiratory valve assembly. If
necessary, take these actions in standby mode or with the ventilator turned off.
① Turn on the Main Power Switch on the side of the shown above, and press
the power and standby mode buttons on the user interface.
② The ventilator will inspect system function status, pressure sensor, flow
sensor, and gas supply status. After Ventilator status check and booting
completed, Circuit Check screen will appear. Touch the Calibration button
and operate Circuit Check.
CAUTION
If the product is turned off during switchover to battery mode, re-inspect after charging
or replace the battery.
C. Operate the product after connecting test lung to Y piece. Check the status of
patient tubes and ordinary operation.
NOTE
If the patient circuit is changed, a Patient circuit check test must be performed.
In case of reboot ventilator, a Patient circuit check test must be performed.
VTe Low (60% * VTi) or (VTi value less than 70ml is 0), whichever is smaller
For ventilation mode without VTi setting parameter:
-. Adult: 250 ml
-. Pediatric: 50 ml
-. Neonate: 0 ml
# Unit: 5 ml
VMe High 150% * VTi * RR
For ventilation mode without VTi setting parameter: (PCV, TCPL is set
to use RR)
-. Adult: 150% * 500 ml * 12RR
-. Pediatric: 150% * 100 ml * 20RR
-. Neonate: 150% * 30 ml * 30RR
# PCV, TCPL is set to use RR
VMe Low 60% * VTi * RR
For ventilation mode without VTi setting parameter: (PCV, TCPL is set
to use RR)
-. Adult: 60% * 500 ml * 12RR
-. Pediatric: 60% * 100 ml * 20RR
-. Neonate: 60% * 5 ml * 30RR
RR High Set RR + 15
For ventilation mode without RR setting parameter:
-. Adult: 40
-. Pediatric: 50
O2 High OFF
O2 Low 20
AIRLEAK High 300 ml
SpO2 High OFF
SpO2 Low 85
PR High 150
PR Low 50
EtCO2 High 6.0 %
EtCO2 Low OFF
iCO2 High 3.0%
iCO2 Low OFF
RR High (CO2) Same as Ventilator RR High alarm value
RR Low (CO2 ) Same as Ventilator RR Low alarm value
Default setting value of alarm range when PBW is not used as follows.
Apnea 2 ~ 60 sec 20 20 10
[ Option, SpO2 ]
High SpO2 52 ~ 99 % / OFF OFF OFF OFF
Low SpO2 51 ~ 99 % 85 85 85
[Option, EtCO2]
NOTE
You should always check the alarm setting after changing the patient type.
NOTE
If you use the PBW function, consider whether you can apply it to the patient before
using the auto set alarm function. Otherwise, set the alarm directed by manually. The
auto set alarm function is set based on the patient's body weight.
Setting values of the ventilator can be configured using touch pad, key, or encoder.
The parameters related with breaths are always measured and adjustable by user. The gas supply
is adjusted to obtain the target values (flow, volume and pressure) through the difference
between the actual measured parameter value and the set or calculated.
MV2000 ventilator has two gas modules (O2, Air). Gas can be supplied through hospital’s medical
gas supply system or compressor and gas container.
CAUTION
If, do not move the ventilator, be sure to lock the wheels in the locked position.
To prevent inadvertent ventilator movement, ensure that each part of the ventilator is secured in
each position on the mobile cart.
②
③
Item Description
Information button
Cancel button
NOTE
Even if this function is activated, an alarm will be activated again when an alarm
occurs due to another cause.
② ④
ATTENTION
Do not use sharp-edged instruments or pointed tools when touching the screen.
At the bottom of the user interface are shortcut key buttons that allow you to
manually adjust the eight default configuration of basic parameters. The
parameters for each button automatically switch to the key parameters of that
ventilation mode, depending on the selection of the ventilation mode.
① ②
④ ⑤
Eight (8) menu buttons are located at the bottom of the user interface. These
buttons can be activated by touching them. The explanation of each menu is as
follows.
The user interface displays system information about the current ventilator.
The types of system information displayed are as follows.
3) Nebulizer ON/OFF
- Valve pump type
Using MV2000 internal tank pressure
Run the Nebulizer valve from 300msec after inspiration start to half of inspiration
start (500msec after start of inspiration) to supply 6.5L / min flow rate to the
patient.
- When setting volume more than 200mL when using volume mode
CAUTION
Do not use the nebulizer with external.
WARNING
Use of this function may affect the tidal volume.
4) Manual Breath
Pressing this button during the expiratory time period, one mandatory breath is
provide as setting value. However, it does not operate during the inspiratory time
period.
NOTE
It does not work in AwPRV / Bi-Level ventilation mode.
5) O2 Boost
Pressing the O2 boost button will feed FiO2 to setting value for 3 minutes. If you
press again within 3 minutes, this function is canceled and return to previous FiO2
setting value.
6) Suction support
Inspiration Hold: When the icon button is pressed, the set volume / inspiratory
time is provided, after that time, the exhalation valve is maintaining condition for
maximum 15 seconds in not open state. At this time, a small information window
is displayed. The remaining time is displayed by count-down at the top, and this
function can be ended by pressing this "Ins. Hold" icon button at any time during
execution. At this time, displays the measured CL, RA, E, TC and the measuring
value is update simultaneously in the monitoring window.
Expiration Hold: When the icon button is pressing, the set volume / inspiratory
time is provided, after that time, the inhalation/exhalation valve is maintaining
condition until before next breath started for maximum 15 seconds in not open
state. At this time, a small information window is displayed. The remaining time is
displayed by count-down at the top, and this function can be ended by pressing
this "Exh. Hold" icon button at any time during execution. At this time, displays the
"Auto-PEEP" measured value and the measuring value is update simultaneously in
the monitoring window.
I: E Ratio: It is ratio of inspiratory time to expiratory time, and display for the
convenience of the user. It displays the information that assists the recognition of
the adequacy of the inspiratory / expiratory time when setting the control variable
which affects this ratio rather than actual value.
CAUTION
Ventilator can be operates by use an external 12V DC power source in case of
emergencies. However, use to internal battery of ventilator or an electrical power as much
as possible for patient safety and stable operation of mechanical ventilation system.
④
②
Alarm Setting
1) Touch the alarms status icon on the bottom of user interface.
2) Select alarm value to adjust.
3) Rotate the encoder to change and modify the value.
4) Touch the value again or push the encoder to save changes.
5) If using the PBW function, the alarm value can be set automatically those alarm
value use by pressing the Auto Set alarm button.
As in 3.4.6, after selecting the ventilation mode and setting the parameters, touching the
ACCEPT button then the ventilator is operated.
If press the STANDBY key during mechanical ventilation, short message will be appeared in
the display window for whether switch to standby mode. Press again the STANDBY button,
ventilation system will go to standby mode. To cancel, press “X” in the upper right corner
on the display
.
After turn on the ventilator and performed "Circuit Check", the STANDBY screen will
appears as shown on the display window.
If selected the "Last" message window and press "START", the last parameter set before
the ventilator is turned on is applied and operates the ventilator.
If select New Patient and select one of Male, Female, Pediatric or Neonatal patient in
Patient Type and press "START", the ventilator will operate to the default setting according
to each Patient Type.
The MV2000 ventilator is equipped with PBW function. When the Patient Type is selected
and the PBW function is turned on, the patient's height can be adjusted within the
applicable range as shown in the table below.
Touch the Mode operation window on the screen to activate the following screen.
A. Set the basic setting and Back-up Ventilation in required Spont or AwPRV/tBi-Level
ventilation mode.
B. Press APNEA mode and select to the ventilation type/mode for APNEA backup.
C. Before pressing the MODE ACCEPT button, set the default settings and the Back-up
Ventilation Parameter settings at the bottom of the screen in consideration of the
patient's condition. This is because these parameters only work in the patient's
apnea state while using the Spont or AwPRV / Bi-Level ventilation mode. You can
confirm this setting by activating the Mode window and pressing APNEA Backup at
any time.
NOTE
The Volume Controlled breath is the default breath type for adult and pediatric patients.
- Adaptive flow
The Intra-Breath Demand System in Volume Ventilation
This function allows the patient to actively breathe and actively breathe
when the inspiratory effort is greater than the set volume and flow rate and
the breathing is longer than the set inspiratory time.
This minimizes asynchrony between the device and the patient's active
breathing effort.
This function is particularly useful in the VACV, VSIMV mode, during the
weaning phase, when the patient's inspiratory effort increases.
This function is described by the following operations.
NOTE
TCPL breath type is only available for Neonates. This is the default breath type for
neonate patients.
The PRVC mode operates in pressure mode, but is aimed at the inspiratory
volume of the patient. The first breath in PRVC mode is test breathing. Test
breathing measures the patient's dynamic compliance by supplying the set
volume of patient volume.
Test breathing,
1. When you first start PRVC,
2. If you are already working If your weight changes,
3. It is performed automatically when patient inspiratory volume is less
than 50% or more than twice volume control target value.
From the second breath, the inspiratory volume is supplied to the patient
while adjusting the inspiratory pressure of the patient according to the
patient's purity. Since the mode is set to operate with the inspiratory
volume of the patient, the patient's inspiratory pressure also changes as the
patient's affinity changes.
If the inspiratory volume of the patient and the supply volume differ by
more than +/- 100 mL, or if the patient inspiratory volume is less than 50%
or more than twice the volume control target value, rapid feedback is
performed, 7cmH2O to control patient intake volume. After rapid feedback,
the patient's inspiratory volume and supply volume will perform fine
feedback within a difference of less than 100 mL, with a change in
inspiratory pressure up to +/- 3 cmH2O.
In the PRVC mode, the patient's inspiratory pressure can be limited by
setting a pressure limit. The patient inspiratory volume is then determined
by the set pressure limit and patient compliance.
B. When the inspiratory time has passed, end the inspiration. At this time, if the
set one-time volume can’t be reached, the next inspiration is increased to
increase the inspiration.
At this time, the height does not exceed the set maximum pressure
C. Before reaching the inspiratory time, reach the set volume early, end the
inspiratory time, and lower the pressure on the next inspiratory.
At this time, the lowest PEEP + 6cmH2O is not lowered.
D. If the newly set one-time volume is set to greater than the present (200% or
more, 50% or less), the first breathing operation of 1) is repeated.
NOTE
IF PSV level is insufficient to meet patient demand, premature termination of the breath
may occur with auto-cycling. In these cases the PSV level should be increased slightly.
The first picture above shows the case where the PSV pressure set
point is insufficient compared to the patient's requirement, and the
second picture shows the result when the PSV pressure is slightly
raised in this patient.
En_Sense
En_Sense means Inhalation-Trigger Enable Sensitivity. This function is
proportional to the inspiratory volume, and activate the next inspiratory
trigger after a certain amount of expiratory volume.
If, use this function, the ventilator allow patient trigger, prevent
retriggering and can be maintains successful ventilation to the mandatory
breath.
For example, the patient can has the high airway resistance and too much
Ascites (Abdominal Dropsy). In case of these symptom has the other
solution to protect retriggering.
NOTE
The ventilator does not creates pressure below the atmospheric pressure during
expiratory phase.
Item Description
PRVC Pressure regulated volume control mode
PRVC-SIMV Pressure regulated volume controlled synchronized intermittent mandatory
ventilation
VCV Volume control mode
V-ACV Volume assist controlled ventilation
V-SIMV Volume controlled synchronized intermittent mandatory ventilation
PCV Pressure control mode
P-ACV Pressure assist controlled ventilation
P-SIMV Pressure controlled synchronized intermittent mandatory ventilation
SPONT Spontaneous Ventilation
AUTO Auto ventilation
CPR Cardiopulmonary resuscitation ventilation
tBiLevel Bi-level positive airway pressure ventilation
AwPRV Airway pressure release ventilation
TCPL Time cycled pressure limited mode
TCPL-AC Time cycled pressure limited assist controlled ventilation
TCPL-SIMV Time cycled pressure limited synchronized intermittent mandatory ventilation
O2Stream Continuous containing O2 flow controlled ventilation
HFV High frequency ventilation
S HFV Single high frequency ventilation
D HFV Dual high frequency ventilation
In SIMV mode, the ventilator can deliver both mandatory and demand breath types.
Mandatory breaths are delivered when the SIMV “time window” is open and one of the
following occurs:
A patient effort is detected;
The breath interval has elapsed with no patient effort detected;
The MANUAL BREATH key has been pressed.
The breath cycle is determined by the preset number of breath per minute. This breath
cycle is reset when the user change the number of breath per minute or press the
MANUAL BREATH button.
All breathing in the spontaneous ventilation mode is demand breath due to the
inspiratory effort of the patient. The exception is when the MANUAL BREATH button is
pressed and Apnea backup ventilation is enabled. When you press MANUAL BREATH, a
single breath is delivered, which depends on the Apnea backup ventilation setting
already set.
CAUTION
When use to Spont Ventilation mode, be sure to comply the follows.
1) Select the breath type for APNEA backup ventilation, press encoder and set each
parameter of VT or PInsp, RR and TInsp according to patient condition.
2) Before accepting the Spont Mode or operate to Spont mode, should perform to above
step 1. If, Spont Mode Accept button (or Encoder key) is pressed without this setting,
the apnea setting window will not be displayed. In this case, open again the Spont
Mode window and use it after parameter settings according to above step 1.
Non-Invasive Ventilation
The MV2000 ventilator supports non-invasive ventilation mode. In order to use this
function, MASK (Leak compensation) must be turned on and used in the setup window.
NOTE
Use only the non-invasive ventilation mask. Non-invasive ventilation requires use of
specific fitting mask with no leak holes. Excessive leaks around the mask may not be
detected trigger of ventilator or may occur of circuit disconnect alarm and high leak
alarm.
NOTE
Clinically, problem of determines weaning of mechanical ventilation, ventilation support
and discontinuance from the ventilator should be treated with very carefully.
After weaning of ventilation support by the ventilator, re-intubation often occurs. This
means that proper and effective respiratory support methods are needed after the
respiratory support discontinuance by the ventilator.
The therapeutic function provided for this purpose is O2 Stream (High Flow Therapy).
This feature will use a specially designed nasal Cannula and a humidifier.
Generally, in ventilator weaning process, T-piece method is widely used, but this
ventilation mode of O2 Stream can be used without additional device. It is convenient to
use continuously without separation from the patient, and can deliver accurate
temperature, humidity and controlled FiO2.
O2 Stream breaths are:
1) Inspiratory Peak Flow (lpm)
2) Pressure Limit (cmH2O)
3) Oxygen Concentration (%)
AutoVent
In single mode, ACV, SIMV and spontaneously operates actively according to patient's
condition and guarantees minute volume simultaneously.
There is no patient's respiratory function abnormality like the recovery room. However,
in case of self-sustained respiration after the end of anesthesia, it is necessary to
maintain the patient's respiration by mechanical ventilation (spontaneous breathing)
Effective ventilation mode.
However, due to the patient's airway management and patient's illness, other clinical
results may occur.
In order to find the best of Work of Breathing (WOB) at a given minute volume, the staff
will manage the patient with three adjustments: % MinVol, PEEP, O2, and this guideline
includes Weaning induction at the same time.
When the patient's self is strong, it operates like Spont + PS (minimum 5cmH2O) +
10secondsapnea time, and it is a breathing mode with the ability to automatically adjust
the patient's breathing and the occurrence of apnea more than 10 seconds.
A. Strong point
Patient management is performed without switching modes of CMV, SIMV, and Spont.
Simplicity of mode management and patient setting information can be simplified.
- Weaning is relatively safe against apnea, because it ensures a minute volume
without any risk of apnea during induction.
B. Limitation
- Because it involves a very different concept from the previous one, there is a need
to educate about the new method, and in the absence of education, it is highly likely
to be understood as a universal function, and the patient may be neglected
inappropriately.
- In case of incompatibility such as Auto-Triggering with patient, operation becomes
unstable and patient management is still necessary.
- The determination of% Vmin makes it possible to increase or optimize the patient's
WOB. Therefore, it is necessary to manage the patient according to the new training
and guidelines as compared with the existing mode.
- Patient's breathing gas concentration, blood gas concentration, etc., may be difficult
to optimize by monitoring compared with normal mode. (There is a limit to the
applicability of patient-specific special situations.)
CPR
(Cardiopulmonary Resuscitation)
CPR mode helps to patient ventilation in the CPR situation of patient.
SHFV
(Single High Frequency Ventilation)
High Frequency Ventilation was developed with the ideal of providing “gentle breathing”
for every patient from newborn infants to adult patient.
In the case of COPD, ARDS, etc., it is difficult to obtain tidal volume in normal ventilation
mode, therefore it is clinically tried if it is difficult to obtain minimum ventilation necessary
to keep life.
However, it is determined that breathing takes place by maximizing gas exchange effect
by the diffusion of optimizing waves. Therefore, it is important to use it by deciding
clinically proper frequency for the patient and 1 cycle inhalation-exhalation volume
(stroke volume) or power (or amplitude).
The average pressure (MAP) value can be set according to the patient's lung condition.
By increasing the amplitudes of Pmax and Pmin, the airway pressure is greater than the
½ amplitude.
The oxygen concentration should be set at least 10% higher than the mechanical
ventilation setting. Set the oxygen concentration according to the patient's condition and
the decision of the clinician or medical staff.
The pressure and number of breath rate applied to the patient will vary according to the
patient's lung compliance and patient circuit compliance. The Power applied to the patient
must be determined by monitoring continue to patient's condition.
To avoid applying negative pressure to the patient, the maximum pressure amplitude is
limited by the MAP. Adult pressure amplitude is limited up to ± 40 cmH2O and Infant
pressure amplitude is limited up to ± 30 cmH2O.
In the high frequency ventilation system, it is important to monitoring uses the SpO 2 and
EtCO2 measurement functions for increase of actual patient respiratory efficiency.
Keep the humidity of the gas delivered continuously to patient due to the dry gas pass
through a large amount of low. The humidification delivered to the patient is very
important.
While operating the HFV mode, press the 'Manual Inspiration' button and the set pressure
is delivered to the patient.
To deliver the maximum power to the patient, should be used rigid breathing circuit.
Use in the High frequency ventilation mode, should configure with the following breathing
circuit are recommended. For neonate/infant patients, it is recommended to use a
breathing circuit (diameter 15mm) for children. For pediatric patients, it is recommended
to use an adult breathing circuit (diameter 22mm
In the case of adult patient, the solution to the water problems is as follows.
1) Using Anti-wet Typed Bacteria filter(Pall Manufacturer)
2) Remove the exhalation valve assembly's water trap bottle. In adult case, it does not
affect the HFV operation.
3) Using Heated bacteria filter system (VADI Manufacturer)
DHFV
(Dual High Frequency Ventilation)
The DHFV mode provide the intermittent exhalation time that can be supplemented the
insufficient time of ventilation in the SHFV mode.
1) Power (%)
2) MAP (cmH2O)
3) Respiratory Rate (b/min)
4) Frequency Range (Hz)
5) IMV time (sec)
6) Oxygen Concentration (%)
7) PEEP (cmH2O)
Primary Control
These are setting variables of the meaning of the textbook, and other special variables
are adjusted in the mode setting window.
The default settings that are set according to the user's intent directly affect the
patient's breathing. Each setting variable is always displayed at the bottom of the
screen. Only the setting variables corresponding to the selected ventilation mode are
displayed.
Up to 8 setting variables are displayed according to the selected ventilation mode.
Even if ventilation mode changes, RR, PEEP, Trigger, FiO2 etc. are located at the same
position.
Even if that parameter changed, it does not affect the ventilation immediately. Press
again the corresponding parameter window or press ACCEPT in as shown the figure for
apply the changed value.
If pressed CANCEL, the value is returned to the original setting value.
Peak Flow
The peak flow rate is the flow rate (flow rate) of the respiratory gas delivered during
inspiratory phase in TCPL breath or mandatory breath.
Range: 5 to 120 L/min
Defaults: 8.0 L/min (Neonate)
Trigger Type
The default setting is Flow trigger, but it can change it to Pressure or turn it off as
needed. To change the setting, press the Trigger setting parameter and the current
Trigger type is displayed in the setting window. It can be changed the trigger type by
turning the encoder dial and accept that setting by user
NOTE
When the Mask (Leak compensation) function is on, even if additional leaks occur, the
leakage is compensated within 2 to 3 breaths and the trigger sensitivity is
maintained.
Pres Trig
If the pressure drops below the PEEP by the set pressure, it will be recognized as a
patient's inspiratory effort and activates triggered.
Range: 0.5 to 20.0 cmH2O
Default: 3.0 cmH2O
% O2
Control of % O2 to determine the oxygen concentration delivered to the patient.
Range: 21 to 100%
Default: 40%
The sub-setting control variables are means to the setting variables displayed in window
of ventilation modes. These control variables are in subordinated to related ventilation
mode only and operates. When user touch the ventilation mode display window of the
arrow marked as shown figure, the Ventilation Mode Select Window appears at the
bottom of the screen. In this window, user can select the ventilation mode at the top of
screen (arrow marked) and only the setting variables required for the selected
ventilation mode are displayed. At the bottom, the basic setting variables for each
ventilation mode are located. The position of each basic setting variable is placed in the
same position even if this setting window is closed, which helps to minimize the user's
mistake.
This section describes the set-up variables that are supplementary when the
corresponding ventilation mode is set. These variables are placed on icons of smaller size
above the default configuration variables. For convenience, variables that are related to
the default configuration variables are placed close together.
MV2000 ventilator supports both of A / C (Assist control) & SIMV ventilation. This
function located on the right side of ventilation mode setting window to enable / disable
the SIMV as shown above in VCV, PCV, PRVC, TCPL ventilation mode. In case of OFF
status, it operates as A / C, when it is ON status, it operates as SIMV. At this time, the
Pressure Support Ventilation (PSV) control variable that can be used in addition to SIMV
and appears simultaneously. PS is in the default setting position, and the rest is in the
NOTE
This function minimize the work of breathing to patient's expiratory phase in Pressure
Support. In other words, the patient's breathing effort is reduced and the ventilator
responds quickly to patient breaths.
Expiratory phase can be taken place only when it exceeds the target pressure after
patient finishes to inspiratory phase. In this case, response speed is late and it needs
patient’s effort.
The mechanic characteristic in PSV is not same in each ventilation mode. 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.
Supplies decelerating flow rate into the patient’s lung in the beginning and inputs the
volume effective of breathing at the same time.
Therefore it is possible for relatively efficient breathing on the premise of the same time
and volume.
If the user determines flow pattern with inhalation time (Ti) and Pause Time (Tpause),
target volume (ml), F-end[%], the ventilator delivers patient’s flow rate by automatic
pre-calculating Flow Peak and flow pattern, it is the convenient mode.
Sigh
The sigh function is to deliver 1.5 times as much ventilation volume as the tidal volume
that is set once for every set number of breaths.
The sigh function is to provide a large volume of inspiration to the patient by providing
an inspiratory volume of 1.5 times the set volume per constant breath in volume mode.
CAUTION
This function is only available in VCV ventilation in adult and pediatric patients.
Real time measured and calculated values are displayed during mechanical ventilation.
This chapter describes the display, additional display of measured and calculated values,
and a list of all displayed values.
The list of monitoring provided by the MV2000 ventilator are shown in the table below.
4.1.1. Display
Measured parameters and the following details are displayed on left side of the screen.
The measured value display shows 6 main measured values on the left side and 10
auxiliary measured values on the right side
1) Alarm Limit
2) Displayed in red if measured value is out of upper limit value or lower limit value of
Alarm Limit.
3) If value cannot be measured, it is displayed as ‘----‘.
4) Parameters displayed on measurement value screen can be changed in connection with
monitoring menu.
4.1.5. Characteristics
Waveforms are displayed on the screen as follows.
Measured parameter values are displayed according to time axis.
To change displayed graphs, touch waveform. The following window appears for each graph,
allowing user to select wanted graphs.
By selecting the setting button below the trend table, it is possible to change the size of
vertical axis of time interval of graph.
4.4. Freeze
Pressing the FREEZE button will show the real-time graphic screen in the stopped state.
Press it again to switch to the real-time graphic. In the still screen, the values of the
display line and the graph are displayed. The line is moved to the time axis by turning
encoder. This function also works on Trend and Loop screens. For example, the
functions on the Freeze screen are as shown below
4.5. Maneuvers
4.5.1. P-V Tool
9
8
10
1
2 3 4 5
To use the P / V tool, press Tool on the left side of the screen and the screen as shown on the
left above will appear. If you press Accept, the execution screen will appear as the right picture.
1) Start/Cancel Start and Cancel the P/V Tool function.
2) PINSP Input the target of Inhalation Pressure, the range is from 5 to 60
cmH2O.
3) FLOW Input the target of flow, the range is from 5 to 15 lpm.
4) PEEP Maneuver PEEP sets the baseline pressure at which the maneuver is
terminated. Pressing the 'Start' button from which the ventilation
mode setting parameter PEEP this maneuver is initiated, up to the
pressure set in the 'Pinsp' and Inspiration to a patient at a rate set
in the 'Flow', when it reaches the 'Pinsp' is expiration in the same
set , this maneuver will be terminated at the maneuver PEEP set
value.
Note: The maneuver PEEP set at this time is independent of PEEP
set during mechanical ventilation. If the two PEEP settings are
different, after a single maneuver has been performed, the PEEP set
during mechanical ventilation will change to the maneuver PEEP
setting.
Range: 0 to 45 cmH2O
Resolution: 1 cmH2O
5) P trig. If the peak airway pressure is reduced by the patient's inspiratory
effort by the set sensitivity, the P-V tool maneuver will terminated.
Range: 0.1 to 5.0 cmH2O
Resolution: 0.1 cmH2O
Default: 3.0 cmH2O
6) Cursor data The Cursor ‘+’ column shows the values for the points on the
inflation limb of the curve. The C1 and C2 show the calculated
compliance in ml/cmH2O for a straight line that connects the cursor
points.
NOTE
Routine mechanical ventilation is stopped while the PV tool maneuver is running. If the
spontaneous breathing of the patient is detected during the PV Tool Maneuver is running,
the message is displayed in the window and PV Tool Maneuver execution is stopped.
Esophageal pressure
The problem of determining patient's PEEP is a very important issue in determining
alveolar adsorption and basal lung pressure. If the patient's PEEP is set low, gas exchange
is difficult enough, and if it is excessively large, the patient's lung will be stressed. By
measuring esophageal pressure, trans-pulmonary pressure can be inferred. It helps to set
the PEEP proportional to the trans-pulmonary pressure.
Tracheal pressure
Patient's circuit and intubation, ET tube, leakage, etc. may cause patient to have pressure
in the lung and measurement error of the equipment. This function allows the ventilator
to be controlled by measuring the direct pressure by inserting a catheter into the
intubation tube. The airway pressure displayed on the ventilator is higher than the set
value.
- ΔP aw
The difference between peak airway pressure (PPEAK AW) and baseline airway pressure
(PEEPAW).
- ΔP es
The difference between peak airway pressure (PPEAK ES) and baseline airway pressure
(PEEPES).
Patient's circuit and intubation, ET tube, leakage, etc. may cause patient to have pressure
in the lung and measurement error of the equipment. This function allows the ventilator
to be controlled by measuring the direct pressure by inserting a catheter into the
Chapter 5 Alarms
5.1. Information
The MV2000 ventilator includes an alarm system for the patient’s safety. In case of the
following problems, alarm sounded and visual alarm appears in display window.
This Chapter describes general response method, sequence of alarm setting (refer to
Chapter 4 Operation Method for details), range of alarm setting, and list.
Refer to Chapter 8 Alarm Message for details on causes and solutions to all alarms.
WARNING
Potential risk can be increased if default alarm values applied to ventilators or other similar
devices used in same place differ from each other.
ATTENTION
If alarms occurred, must be take action by a medical professional with experience in
ventilator treatment or trained with MV2000 ventilator individually.
WARNING
If the alarm setting values are set to very high or very low limit alarm value or "OFF", the
alarm will not be occurred and it cannot take proper action to patient and it may cause
danger.
1) The alarm message window blinks and cause of the alarm is displayed.
2) The window of corresponding measured value to occurred alarm will be blinks and
displayed.
More than one alarm can be checked through alarm message displayed on top of the
screen. To check more alarms,
1) Select alarm message window.
2) Select Alarms in the Events menu, can be checked all alarms that occurred recently.
NOT
User can mute the audible alarm even if the alarm condition does not end. However,
depending on the situation, it can be occurred that audible alarm again.
1) Select System button among menu buttons located at the bottom of user interface.
2) Select Setup in the System menu.
3) Activate sound volume by touching Sound Vol. Adjust the volume of alarm sound.
Once adjustment is complete, touch again to deactivate the window.
Configured alarms values are displayed on the left side of the screen and in measurement
value window at the bottom. Among displayed alarm values, value above is the upper limit
and value below is the lower limit.
5.4.1. Introduction
This section describes alarms and measures on each alarm message.
NOTE
Contact service assistant for most of technical errors.
WARNING
When conducting an act that can bring risks to the patient such as replacement of O 2 cell,
always separate the ventilator from the patient.
CAUTION
When the ventilator is in operation, do not raise or separate expiratory valve assembly.
However, it may be separated in stand-by mode.
CAUTION
The mechanical alarms of the ventilator are 'O2 Pressure Fail', 'O2 CELL ERROR', 'BATTERY
MODE', 'LOW BATTERY' and 'COM ERROR'. 'SpO2 check Probe', 'Alarm Error', 'Search' and
'Check Probe' are mechanical alarms of SpO2. Other alarms are physiological alarms.
When an alarm message occurs, check current mode and settle the problem immediately.
Alarm
Occurrence
Message
No (Immediate Criteria and potential cause
(Alarm
/ Separate)
Priority)
There is no spontaneous breathing in the apnea
Apnea After apnea period
1
(High) time If, there are two self-breathing of patient within 10
seconds, it switches to Spont Mode.
Air OBST
2 Immediate Inspiratory or expiratory port areas are obstructed.
(High)
Measured value of Minute Volume is higher than
alarm limit
After more Patient breaths has been increased by patient's
than 1 effort.
VMIN HIGH
3 minute Self-triggering (auto cycling) occurred in the
(High)
ventilator ventilator.
operation. Alarm setting value is inappropriate
This alarm is activated after ventilator operation for
1 minute or longer.
LOW
When the internal battery use time is remaining 5
20 BATTERY Immediate
minutes
( Mid )
Chk. P.
Sensor port of Exhalation valve assembly is not
23 Port Immediate
connected or obstructed.
(High)
CAUTION
For each of the following alarm verification test, user must reset to the previously set alarm
value before proceeding to the next (subsequent) test item after each test.
Requirement Equipment
Test Lung
Adult patient circuit
If the alarm does not activates as indicated, verify the ventilator settings again and repeat
the test. The alarm tests check the operation of the following alarms.
Circuit Open
Low Exhaled Mandatory Tidal Volume
Low Exhaled Total Minute Volume
AC Power Loss
Apnea
Oxygen Supply Fail
Obstruct alarm test
Follow the process of cleaning and disinfection by the hospital regulations and instructions.
Follow the cleaning instructions provided by the manufacturer of each assembly as well as
your facility’s policy
Definition of clean: the remove of all foreign material (for example, organic matter) from
objects. Cleaning is normally accomplished by washing with running water (tap water),
mechanical action, or enzymatic products.
1. Disassemble (separate all components).
2. Wash part in water or enzymatic cleaner.
3. Rinse part thoroughly in clean running water for at least two minutes and wipe dry or
allow to air dry thoroughly.
4. Inspect part after every cleaning. Replace damaged or worn parts
CAUTION
Always follow soap manufacturer’s instructions. Exposure to a highly concentrated soap
solution can shorten the useful life of a part. Soap residue can cause blemishes or cracks,
particularly on parts exposed to elevated temperatures during cleaning.
CAUTION
Do not sterilize the entire ventilator. Standard sterilization techniques, including EO gas
and formalin, may cause damage.
Cleaning process for when had been used bacterial filter in breathing circuit.
Disassemble
Wiping / Disposal
Reassemble
Disassemble
Wiping / Disposal
Cleaning
Cleaning Disinfectant
Sterilizer
Cleaning
Drying
Reassemble
CAUTION
Do not soak the battery, EtCO2 module, SpO2 sensor and any sensors in any liquid solution.
NOTE
In case of severe degree of contamination, ethyl alcohol (70%) or isopropyl alcohol (70%)
is used. Avoid contact with electronic connectors.
NOTE
The following items in the patient breathing circuits with accessories that may be
contaminated with fluids or exhaust gases under normal or single fault conditions are as
follows.
- Inspiratory and Expiratory filters
- Proximal Flow Sensor
- Exhaust component parts (Exhaust vent and Diaphragm)
6.3.2. Disposal
- Bacteria filters (disposable)
- Humidification chamber (disposable) or HME (disposable humidifier)
- Disposable tubes and disposable breathing circuits.
ATTENTION
Cleaning can easily remove contaminants and reduce risks of cross infection between
patients. Cleaning immediately the exhalation valve assembly after use, it’s another
effective method for sterilize.
ATTENTION
- All parts must be dried after the disinfection process is finished.
- Exhalation valve assembly is precision component parts and must be handled with care.
6.4.1. Disinfectant
Soak the component parts of reusable into one of the following disinfectants.
- Alcohol (Ethyl or isopropyl alcohol 70%)
- Cidex OPA
- Hexanios G+R
- Aniosyme DD1
- Gigazyme Plus
- Anioxide 1000
ATTENTION
Follow recommendations and guidelines by the manufacturer. Otherwise, it may damage
the component parts.
ATTENTION
Chemical precipitates may influence the patient, induce leakage, or damage parts.
NOTE
If drying process is carried out by cleaning sterilizer, it does not need to additional drying
process.
Do not use by high pressure gas to do dry the exhalation valve assembly, inside component
part of exhalation valve assembly such as flow sensor can be damaged.
6.5. Assemble
In case of Exhalation Valve Assembly, assemble the component part in the reverse
sequence of disassemble the 'exhalation valve assembly'
NOTE
- Wipe the main body/sensor using soft cloth with disinfectant (Cidex OPA or isopropyl
alcohol 70%).
- After cleaning, wipe the module/sensor using soft cloth soaked in water.
- Module/sensor must be dried after cleaning.
ATTENTION
Do not soak the EtCO2 module/sensor in solutions like water.
- Soak the airway adapter in Cidex OPA solution during cleaning.
- Clean airway adapter using distilled water.
- Airway adapter must be dried and wiped before re-using.
ATTENTION
Follow recommendations and guidelines of the manufacturer on the use of disinfectants.
- Airway adapter for adult can be cleaned in accordance to cleaning regulation of each
hospital.
- After cleaning process, adapter must be dried prior to use
6.7. Humidifier
For instructions on how to clean and disinfect, please refer to the Humidifier user manual.
6.8. Nebulizer
WARNING
Never use with flammable medications! The hot thermal conductor used to the flow sensor
in the exhalation valve assembly can cause a fire hazard.
WARNING
Do not connect the bacterial filter or HME on the nebulizer outlet or on the Y-piece during
nebulization by the nebulizer! Risk of increased breathing resistance! Increased resistance
to patient.
Do not use the nebulizer if the number of breath rate per minute is 12 or less.
WARNING
In case of use the pneumatic nebulizer, due to the nebulization volume, the display on the
screen may be larger or lower than normal volume per minute or volume per breath. When
using a medical nebulizer, use the pressure ventilation.
When compares and measured the minute volume or tidal volume per breath before
using the pneumatic nebulizer and after using nebulizer, it can be seen that there is a
slight difference the measured value. If measured volumes are severe difference, use
the pressure ventilation mode.
WARNING
Without cleans and, if store the flow sensor at the exhalation valve assembly after using
the medical nebulizer, flow or volumes measurements may not be possible. In the worst
case, the flow sensor is damaged or Peep pad block area is may be obstructed.
6.9. Maintenance
Maintenance schedule
Period Parts Service Code Check point
30000 hours Over All Maintenance MP001
7500 hours Inlet Filters MP002
15000 hours SV1, SV2 Blending Valves MP003
20000 hours PV1 Proportional Valve MP004
20000 hours LS1 PEEP Valve MP005 Exchange to new part
50000 hours SV3 Neb. Valve MP006 when the service code
50000 hours SV4 Safety Valve PAD MP007 is generated.
-- FiO2 Sensor MP008
10000 hours Battery MP009
8760 hours PEEP System MP010
2160 hours PEEP PAD MP011
CAUTION
User should check the installation status and problem of the filters and patient circuit
system with visual inspection every day. In case of any problem, replace or supplement
the parts in problem right away.
When patient is changed or one patient uses it for a long period, replace the patient circuit
system including bacteria filter in every 15 days, and clean that reusable components.
Refer to manufacturer guidelines.
Steam Autoclave available use only for the reusable bacteria filter.
Oxygen sensor is valid for 2 years, but it can be shortened in case of using at the condition
of high FiO2 or high temperature. Refer to manufacturer guidelines.
Internal battery is used to supply power to the product when the patient is moving or
electrical power source of facility is failure. Battery is automatically charged when external
battery is supplied. Once commercial power supply is terminated or power supply is
suspended accidentally, power is automatically switched to internal battery. Remaining
battery is indicated on the LCD monitor.
In case of abnormality in battery, contact [Sales / Customer Service] for necessary service.
6.9.3. Accessories
Refer to User Manual of Humidifier manufacturer for details on cleaning methods.
Check the following matters before transporting the ventilator whether, the ventilator is
connected to a patient, or not.
- Check whether patient unit and user interface are firmly fixed and locked.
- Check whether accessories such as modules and humidifier are firmly fixed.
- Check the connection of gas container and amount of gas in the container.
- Check whether battery is sufficiently charged.
- Check whether the ventilator operates properly.
- Check damages on the mobile cart.
- If medical portable compressor is used, make sure it is firmly fixed to prevent
movement during transportation.
6.11. Storage
- When store or standby the ventilator, always connect to main power source for
battery to be charged sufficiently.
- Do not discard battery and O2 cell together with ordinary wastes.
- Do not expose the ventilator to a temperature below -20℃ (-4℉) or above
+70℃(+158℉).
WARNING
- Heated humidifier must be turned off when using nebulizer. If do not turn off the heated
humidifier, it may influence the particle size of absorption drug.
- Unexpected increase to ventilation gas temperature may result from use of
unauthorized heated humidifier.
CAUTION
- If heated humidifier is uses, the water trap may need connected to the expiratory tube
line because of water condensate occurs in the expiratory tube.
- Frequently check the water trap during operation and empty that water in the water
trap accordingly.
ATTENTION
- Since use of soft tube with extremely high compliance can affect functions of the
ventilator, use tubes supplied by our company if possible.
- Supplementary accessories connected to the patient’s tube can influence patient
pressure.
EtCO2 sensor displays the measured expiratory end CO2 concentration as a graphic
waveforms on the screen.
The IRMA CO2 main stream CO2 probe is intended to be connected to medical ventilator
and other monitoring devices for display of real time and derived monitoring data of CO2.
It shall be always used in combination with other vital signs monitoring devices and/or
should be used at the discretion of a person with a professional knowledge of the patient's
condition.
The IRMA probe is intended to be used by trained and authorized health care professionals
only.
WARNING
- Only use CO₂ components certified by our company.
- The IRMA sensor probe is intended for use by authorized and trained medical personnel
only.
- The IRMA sensor 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 (hospital)
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 sensor 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
connector of breathing circuit end as this may allow patient secretions to obstruct 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 sensor 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 sensor probe zeroing will be resulted in false gas readings.
- Replace the adapter if rainout/condensation occurs inside the airway adapter.
- Use only the IRMA airway adapter, manufactured by the PHASEIN manufacturer.
CAUTION
- Never sterilize or immerse the IRMA sensor probe in liquid.
- Do not apply tension to the probe cable.
- Do not operate the IRMA sensor probe at the out of range that 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 products. Do not autoclave the adapters, it
will damage and cannot be used.
WARNING
- The connectors on the SpO2 Extension cable are light silver color.
- The connector of the EtCO2 Extension cable is black color.
- Be careful when connecting two of device cables to prevent any errors.
- If two device cable connectors has been wrong inserted, it may damage the sensor
due to incorrect pin connection. If the sensor malfunctions after wrong connections,
please contact customer support team or certified service engineer.
7.3. SpO2
Oxygen saturation shows the degree of concentration of hemoglobin that carries
oxygen in the artery. That is, it displays the degree of currently carried amount
compared to oxygen carry able by hemoglobin as a percentage. It does not show the
amount of carboxyhemoglobin or methemoglobin hemoglobin from hemoglobin disorder.
WARNING
- Only use SpO2 sensor certified by MEKICS. If any different products are used, it may
cause problems in performance.
- When waiting for measurement, the displayed value is “standby” and “---“.
- The user department and operator needs to verify the compatibility of the monitor,
sensor probe, and cable before use.
- Incorrect methods such as tight fixation of sensor using fixing tape can harm the
patient’s skin and tissues.
- Sensor probe 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.
- Automatic self-test of alarm signal generation is not provided, if you want to test the
CAUITON
- Do not use the sensor to patients with allergic symptoms to SpO2 sensor probe.
- Do not use SpO2 sensor during MRI screening because there is risk of sensor burning.
- Immediately remove the sensor if the patient feels for discomfort.
- We recommended maximum application period time for contact duration of pulse
oximeter sensor probe does not exceed 30 days.
- The SpO2 operates even if there is main power interrupted for more than 30 seconds
due to internal battery.
- MEKICS adhesive type of pulse oximetry sensors are intended for single-patient use
only. Do not reuse the adhesive type of pulse oximetry sensors. It may cause degraded
performance.
ATTENTION
Inaccurate values and waveforms can result as below if sensor is used incorrectly.
- 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
- 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
- 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 has hypotension, severe vasoconstriction, severe anemia or
hypothermic symptoms.
- When there is arterial occlusion nearby the sensor
- When the patient is experiencing cardiac arrest or shock
NOTE
- Some models of commercially available functional testers and patient simulators can
be used to verify the proper functional of MEKICS monitoring systems, sensors, and
cables. Reference the individual testing device’s operating manual for the procedures.
NOTE
- The SpO2 concentration and pulse rate measurements are updated every 1 second
typically. Average data and other signal processing on the values of SpO 2 and Pulse
Rate is controlled by the automatically.
- Depending on the magnitude of difference between the alarm limit and the displayed
value, the alarm signal occurs may be 5 seconds delay. Depending on the response
speed of the numerical value, the alarm condition may be 1 second delay. If occurs
SpO2 technical alarm (‘Alarm Error’) occurs, the physiological alarm response time can
be proportionately longer. If the system is configured for SpO2 Alarm Delay, the alarm
occurs is delayed by the configured time.
NOTE
If the SpO2 measurement is delay for more than 30 seconds (due to an excessively
noisy signal or because of trying to measure NIBP and SpO 2 on the same limb), and
SpO2 alarm occurs and the SpO2 numeric display alternates the measured value and
the question mark (-?-).
In order to prevent excessive light for use SpO2 sensor, follow the instructions for use. Use
opaque substances to prevent the sensor from being exposed to external light sources.
Measured values may become inaccurate if surrounding environment is too bright.
Movement of the patient can cause problems, check whether the sensor is being operated
safely. Adhesive-type sensor can be used to reduce measurement errors from patient’s
movement.
1) Clinical Studies
A. Introduction
This chapter contains data from clinical studies conducted for the MEICS sensor used with
the MEKICS SpO2 Patient Monitoring System. This device is used for continuous monitoring
of oxygenation and is important for early detection of hypoxia. Therefore, the validation of
the SpO2 accuracy is essential for patient safety.
B. Methods
This study was conducted in a normal environment at the Intensive Clinical Research
Room of the Medical Center according to ISO 14155: 2011 guidelines and the clinical trial
guidelines of pulse oximeter (Ministry of Food and Drug Safety,
The selected SaO2 values were matched with the corresponding SpO2 values, and the data
were analyzed according to the following statistics: • SpO2 accuracy was evaluated by
Arms for the overall range and by decade
C. Results
Accuracy was calculated using the root mean square difference (RMSD).
D-MDNA WA-100
SpO2
Data Data
Range Arms Arms
Points Points
70-100 275 3.98% 275 2.83%
D. Conclusion
Our results provide supporting evidence that the SpO2 accuracy of the SpO2 pulse oximeter
with a MDNA disposable and WA-100 reusable finger probe passes an Arms specification
of ≤ 4% over a range of 70-100% SaO2, under steady‐state, non‐motion conditions.
Standards
IEC 60601-1:2005+AMD1:2012, EN 60601-1:2006+A1:2013
(Medical electrical Safety)
IEC 60601-1-2:2007, EN 60601-1-2:2007+AC:2010
(Electromagnetic Compatibility Requirement and tests)
IEC 60601-1-6:2010+AMD1:2013, EN 60601-1-6:2010+A1:2015
(Usability)
IEC 60601-1-8:2006+AMD1:2012, EN 60601-1-8:2007+A1:2013
(Alarm System)
IEC 62366:2007+AMD1:2014, EN 62366:2008+A1:2015
(Usability)
IEC 62304:2006+AMD1:2015, EN 62304:2006+A1:2015
(Software life cycle process)
ISO 14971:2007, EN ISO 14971:2012
(Risk management)
ISO 13485:2003, EN ISO 13485:2012
(Quality management system)
ISO 80601-2-12:2011, EN ISO 80601-2-12:2011
(Particular requirements for basic safety and essential performance of critical care
ventilators)
ISO 80601-2-55:2011, EN ISO 80601-2-55:2011
(Particular requirements for basic safety and essential performance of respiratory gas
monitors)
ISO 80601-2-61:2011, EN ISO 80601-2-61:2011
(Particular requirements for basic safety and essential performance of pulse oximeter
equipment)
8.2. Ventilator
8.2.1. General Characteristics
Dimensions (mm)
- Main unit: W326 X D414.2 X H388, approx.
- Display monitor (15.0 inch): W400 X D48 X H276, approx.
- Display monitor (12.1 inch): W307 X D46 X H282, approx.
- Cart: W499.4 X D599.1 X H725, approx.
Weight (kg)
- Device : 35 kg(with Battery)
- Cart : 20 kg
- Max. Weight : 90 kg (including safe working load)
Obstructed Tube - -
Ventilator in-operation - -
Circuit open - -
tBiLevel
- Spontaneous Ventilation
Identical to SPONT mode, but upper PEEP exists.
Monitor
15” TFT LCD
Resolution: 1024 X 768 or 800 X 600
Setting range
Predicted Body Weight ~ 150 kg
Tidal Volume 2 ml ~ 2500 ml
Inspiratory Pressure 0 ~ 99 cmH2O
Pressure Support 0 ~ 99 cmH2O
Respiratory Rate 0 ~ 150 bpm
PRVC, V-ACV, PACV,
Apnea type
TCPL-AC & SIMV
Inspiratory time 0.1 ~ 9.9 sec
Plateau Time (Pause Time) 0 ~ 2 sec
PEEP 0 ~ 60 cmH2O
High PEEP (tBilevel) 0 ~ 99 cmH2O
Low PEEP (tBilevel) 0 ~ 60 cmH2O
Inspiratory Pressure limit 1 ~ 100 cmH2O
Minute Volume (AutoVent® ) 70 ~ 300 %
Inspiratory Flow rate (O2 Stream® ) 5 ~ 60 lpm
Inspiratory Flow rate 5 ~ 120 lpm
Flow limit 10 ~ 60, OFF lpm
Enable inhalation trigger (En-sense) 10 ~ 80 %
Exhalation trigger Sensitivity (Ex-trig) OFF, 5 ~ 80 %
F-end 25 ~ 100 %
Inspiratory Rising Time 0.1 ~ 2.0 sec
Inspiratory Rising Time PSV 0.1 ~ 0.5 sec
OFF,
Trigger sensitivity Pressure
0.1 ~ 20 cmH2O
OFF,
Trigger sensitivity Flow
0.1 ~ 20 L/min
O2 % 21 ~ 100 %
Sigh Mode Off, 30/60/90/120
Setting
Default
range
Nebulizer 10 ~ 180min Off
Measures lung compliance,
Inspiration pause - resistance, elasticity, Time
constant
Expiration pause - Measures auto-PEEP
Manual Inspiration - Deliver One mandatory breath
Deliver 100% Oxygen for 3
100% O2 -
minutes
Key lock - Key & Touch Lock
Graph freeze - Freezes waveform & loop graphs
Turns off alarm sound for 2
Alarm silence -
minutes
Alarm reset - Clear active alarms
Resolution 1%
Accuracy(Arms1) ± 3 digits
± 2 % for readings 70 ~ 100 %
Adult
± 3 %, for readings 50 ~ 69 %
± 3 %, for readings 70 ~ 100 %
Neonate
± 3 %, for readings 50 ~ 69 %
Unspecified 0 ~ 49 %
Display
1
Sensor accuracy was obtained by performing controlled hypoxia studies on healthy, non-
smoking adult volunteers (according to EN ISO 80601-2-61:2011). The SpO2 readings
have been compared to CO-Oximeter measurements on arterial blood samples. To
represent the general population, data from at least 11 subjects (male and female) with
a wide range of skin color was taken to validate SpO2 accuracy.
RF emissions
Class A
CISPR 11
The MV2000 is suitable for use in all establishments,
Harmonic emissions including domestic establishments and those directly
Class A
IEC 61000-3-2 connected to the public low-voltage power supply
network that supplies buildings used for domestic
Voltage fluctuations
purposes.
/
Complies
flicker emissions
IEC 61000-3-3
± 1 kV differential ± 1 kV differential
Surge Mains power quality should be that
mode mode
of a typical commercial or hospital
± 2 kV common ± 2 kV common
IEC 61000-4-5 environment.
mode mode
Voltage dips, < 5 % Uт < 5 % Uт Mains power quality should be
short (> 95 % dip in (> 95 % dip in that of a typical commercial or
interruptions and Uт) Uт) hospital environment. If the user
voltage variations for 0.5cycle for 0.5cycle of the MV2000 image intensifier
<5 % Uт <5 % Uт
(< 95 % dip in (< 95 % dip in
Uт ) Uт )
for 5 s for 5 s
Power frequency Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field 3A/m 3A/m of a typical location in a typical
commercial or hospital
IEC 61000-4-8 environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
The MV2000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MV2000 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 MV2000.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than [V 1] V / m.
NOTE
The components in the gas pathway that can become contaminated with body fluids or
expired gases during both normal and single fault conditions are :
- inspiratory filter
- Expiratory filter
- Flow sensor and proximal flow sensor
- Exhalation valve assembly
Tel: +82-70-7119-2520
Fax: +82–70-5052-5800
e-mail: service@mek-ics.com
Homepage: http://www.mek-ics.com
[EC Representative]
Authorized Representative
OBELIS S.A
Bd. Géné ral Wahis, 53, 1030 Brussels, Belgium
Tell : +32.2.732.59.54
Fax : +32.2.732.60.03
The MEKICS homepage is available to you and provides a page where you can let us know if
you have any complaints. If you have experienced any inconveniences during the use of our
product or have any suggestions for improvement, except for product defects, please feel free
to contact us and help us incorporate your idea.