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User’s Manual

Intensive Care Ventilators

This User Manual may be revised for the improvement of the product, without prior notification.
Images in this User Manual may differ from the actual product.
User’s Manual
This User’s Manual is provided to users with MV2000 Ventilator product.

Since this User’s Manual is compatible with MV2000


Ventilator, it may not be used with other products
manufactured by our company. In case of loss or
damage in the User Manual, you may refer to MEKICS
web site for downloading the manual file.

URL: http://www.mek-ics.com

MV2000 User Manual includes cautions and risks to


users prior to use of ventilator. Please read all cautions
for use thoroughly before operating the product.
You can 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.

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.

MV2000 Ventilator System 2 M01-18-L190 Eng. Ver. 4.42


Contents
A. Device Outline ..................................................................................................................................... 11

i. Device Illustration................................................................................................................................. 11

ii. Device Configuration........................................................................................................................... 11

iii. Usage ............................................................................................................................................................ 11

iv. User ................................................................................................................................................................ 12

v. Environment ............................................................................................................................................. 12

vi. Service guideline ................................................................................................................................... 12

vii. Exceptions for Legal Responsibilities ....................................................................................... 12

viii. Side Effect .................................................................................................................................................. 12

B. Warning, Caution, Important and Reference Matters .................................... 12

i. Summary .................................................................................................................................................... 13

iv. Cautions for Electrical Safety ........................................................................................................ 16

v. Cautions for Electronic Safety ...................................................................................................... 16

vi. Warnings Regarding Environment of Use ............................................................................. 17

vii. Warnings Regarding Hoses, Tubing, and Accessories .................................................. 17

viii. Warnings Regarding Gas Sources .............................................................................................. 18

xi. Equipment Symbols ............................................................................................................................. 20

Chapter 1 Introduction .......................................................................................................................................... 22

1.1 MV2000 Series .................................................................................................................................... 22

1.2 Some MV2000 Features .............................................................................................................. 22

1.2.1 Predicted Body Weight ...................................................................................................................... 22

1.2.2 Full range of Patient Size ................................................................................................................. 23

1.2.3 Leak Compensation ............................................................................................................................. 23

1.2.4 Circuit Compliance Compensation ............................................................................................. 25

1.2.5 ET Tube (Artificial airway) compensation ............................................................................. 25

MV2000 Ventilator System 3 M01-18-L190 Eng. Ver. 4.42


Chapter 2 Unpacking & Setup ......................................................................................................................... 28

2.1 Ventilator Assembly & Setup ................................................................................................. 28

2.1.1 Appearance Symbol............................................................................................................................. 28

2.1.2 Items Required for Ventilator Setup ........................................................................................ 30

2.1.3 Power Source ........................................................................................................................................... 31

2.1.4 Oxygen/Air Supply ............................................................................................................................... 31

2.1.5 Assembling the Ventilator ............................................................................................................... 32

2.1.6 User interface connection method ............................................................................................. 32

2.1.7 Setting up the Exhalation Valve Block .................................................................................... 33

2.1.7.1 Patient Circuit using Humidifier .......................................................................................... 34

2.1.7.2 Patient Circuit with humidifier ............................................................................................. 34

2.2 Front Panel Connections ............................................................................................................ 35

2.2.1 Connect the Nebulizer ........................................................................................................................ 35

2.2.2 How to connect SpO2......................................................................................................................... 35

2.2.3 How to connect EtCO2 ....................................................................................................................... 36

2.2.4 Connect the Proximal Flow Sensor ............................................................................................ 38

2.2.5 Esophageal Balloon (Option) ......................................................................................................... 38

2.2.6 Tracheal Catheter (Option) ............................................................................................................ 38

2.3 User Interface Rear Label or Panel Symbols .......................................................... 39

2.4 Back Panel of Ventilator main body ................................................................................ 42

2.5 Setting system .................................................................................................................................... 43

2.5.1 Setup menu .............................................................................................................................................. 43

2.5.2 SYSTEM decision items ..................................................................................................................... 43

2.5.3 Patient menu ............................................................................................................................................ 46

2.5.4 Calibration menu ................................................................................................................................... 47

2.6 Sensor Calibration ........................................................................................................................... 47

MV2000 Ventilator System 4 M01-18-L190 Eng. Ver. 4.42


2.6.1 Circuit Check ............................................................................................................................................ 48

2.6.2 Exhalation Flow Auto Calibration ................................................................................................ 49

2.6.3 O2 Cell Calibration................................................................................................................................ 49

2.6.4 Expiratory Flow Gain ........................................................................................................................... 49

2.6.5 Adult/Neonatal Proximal Flow Gain .......................................................................................... 50

2.6.6 EtCO2 Zeroing ......................................................................................................................................... 50

2.6.7 EtCO2 Set O2 ........................................................................................................................................... 50

2.6.8 EtCO2 Set N2O ....................................................................................................................................... 50

2.7 Power supply ........................................................................................................................................ 50

2.7.1 Outline .......................................................................................................................................................... 50

2.7.2 Power Supply Specification ............................................................................................................ 51

2.7.3 Battery Information Summary ..................................................................................................... 51

2.7.4 Battery Status Display Screen ..................................................................................................... 51

2.7.5 Alarm and Safety Devices ............................................................................................................... 52

2.7.6 AC Power Supply Failure .................................................................................................................. 52

2.8 Operation Method ............................................................................................................................ 52

2.8.1 Operation Sequence Summary .................................................................................................... 52

2.8.2 Pre-Use Check ......................................................................................................................................... 53

2.8.3 How to start MV2000 .......................................................................................................................... 54

2.8.4 Automatic switchover Between AC and Battery Power ............................................... 55

2.8.5 Inspection of the patient breathing circuit........................................................................... 55

2.9 Default Settings for Adult, Pediatric and Neonate ............................................ 56

2.9.1 Ventilation Setup: PBW OFF .......................................................................................................... 56

2.9.2 Alarm Setting ........................................................................................................................................... 57

Chapter 3 Ventilator Operation ...................................................................................................................... 60

3.1 Ventilator Configuration ............................................................................................................ 60

MV2000 Ventilator System 5 M01-18-L190 Eng. Ver. 4.42


3.2 User Interface Configuration................................................................................................. 61

3.3 How to use the user interface .............................................................................................. 65

3.3.1 How to setting the menu or parameter by touch screen. ......................................... 65

3.3.2 Encoder Setting ...................................................................................................................................... 66

3.3.3 (Direct Access Button) Main setting parameter button ............................................... 66

3.3.4 Menu Key .................................................................................................................................................... 67

3.3.5 Status (System Information Window) .................................................................................... 68

3.3.6 Ventilation Mode and Parameter Setting .............................................................................. 71

3.3.7 Alarms setting ......................................................................................................................................... 71

3.3.8 Starting the Ventilation ..................................................................................................................... 72

3.3.9 Patient Size ............................................................................................................................................... 72

3.3.10 Setting the Ventilation Breath Type and Mode ........................................................ 72

3.3.11 Breath Types ................................................................................................................................... 73

3.3.11.1 Mandatory Breaths ...................................................................................................................... 74

3.3.11.2 Demand Breaths ........................................................................................................................... 76

3.3.12 Ventilation Modes ......................................................................................................................... 78

3.3.13 Primary Breath Controls .......................................................................................................... 88

3.3.14 Descriptions of Primary Breath Controls ...................................................................... 89

3.3.15 Sub-Breath Controls ................................................................................................................... 92

Chapter 4 Monitors,Displays & Maneuvers.......................................................................................... 97

4.1. Measurements display ................................................................................................................. 97

4.1.1. Display ................................................................................................................................................. 98

4.1.2. List of measures and calculated values......................................................................... 99

4.1.3. Monitoring Range ...................................................................................................................... 100

4.1.4. Graphic Displays ........................................................................................................................ 100

4.1.5. Characteristics ............................................................................................................................. 101

MV2000 Ventilator System 6 M01-18-L190 Eng. Ver. 4.42


4.1.6. Wave setting and changing ................................................................................................ 101

4.2. Loop graph........................................................................................................................................... 103

4.3. Trend......................................................................................................................................................... 104

4.4. Freeze ...................................................................................................................................................... 104

4.5. Maneuvers............................................................................................................................................ 105

4.5.1. P-V Tool ........................................................................................................................................... 105

4.6. Esophageal/Tracheal Pressure (Option) ................................................................. 108

4.6.1. Esophageal pressure ............................................................................................................... 108

4.6.2. Tracheal pressure...................................................................................................................... 109

Chapter 5 Alarms ..................................................................................................................................................... 110

5.1. Information ........................................................................................................................................ 110

5.1.1. Alarm display ............................................................................................................................... 111

5.2. Alarm Removal ................................................................................................................................ 111

5.2.1. View Current Alarms ............................................................................................................... 111

5.2.2. Alarm Reset ................................................................................................................................... 111

5.2.3. Mute the Alarm Sound ........................................................................................................... 112

5.2.4. Alarm Sound Volume Control ............................................................................................ 112

5.3. Alarm Setting .................................................................................................................................... 113

5.3.1. Alarm Screen Display ............................................................................................................. 113

5.3.2. Alarm Setting ............................................................................................................................... 113

5.4. Alarm Message................................................................................................................................. 114

5.4.1. Introduction .................................................................................................................................. 114

5.4.2. Alarm and Error Message..................................................................................................... 114

5.4.3. Audible Alarm Prioritization ................................................................................................ 118

5.4.4. Alarm Test ...................................................................................................................................... 118

Chapter 6 Maintenance and Cleaning .................................................................................................... 121

6.1. Summary of Cleaning Process ........................................................................................... 121

MV2000 Ventilator System 7 M01-18-L190 Eng. Ver. 4.42


6.2. Preparation / Disassemble................................................................................................... 123

6.2.1. Preparation .................................................................................................................................... 123

6.2.2. Detaching and disassemble the Exhalation Valve Assembly ....................... 123

6.3. Wiping / Disposal ......................................................................................................................... 124

6.3.1. Wiping ............................................................................................................................................... 124

6.3.2. Disposal ........................................................................................................................................... 124

6.3.3. Cleaning before disinfection ............................................................................................... 125

6.4. Cleaning process ............................................................................................................................ 125

6.4.1. Disinfectant ................................................................................................................................... 125

6.4.2. Rinsing After Cleaning ............................................................................................................ 126

6.4.3. Drying Method ............................................................................................................................. 126

6.5. Assemble ............................................................................................................................................... 126

6.6. EtCO2 Module/Sensor Cleaning ....................................................................................... 126

6.6.1. Preparation .................................................................................................................................... 127

6.6.2. EtCO2 Module Body/Sensor ............................................................................................... 127

6.6.3. Airway Adapter ........................................................................................................................... 128

6.7. Humidifier ............................................................................................................................................ 128

6.8. Nebulizer ............................................................................................................................................... 128

6.9. Maintenance ....................................................................................................................................... 129

6.9.1. Preventive Maintenance and schedule ........................................................................ 129

6.9.2. Battery Replacement .............................................................................................................. 130

6.9.3. Accessories .................................................................................................................................... 131

6.10. Transportation and Storage in Hospitals................................................................. 131

6.10.1. Prior to Transportation .......................................................................................................... 131

6.10.2. During Transportation ............................................................................................................ 132

6.10.3. Transportation Between Hospitals ................................................................................. 132

6.11. Storage ................................................................................................................................................... 132

MV2000 Ventilator System 8 M01-18-L190 Eng. Ver. 4.42


Chapter 7 Option ...................................................................................................................................................... 133

7.1. Humidifier ............................................................................................................................................ 133

7.2. EtCO2 (Option) ................................................................................................................................ 133

7.2.1. EtCO2 Calibration........................................................................................................................ 135

7.3. SpO2 .......................................................................................................................................................... 135

7.3.1. SpO2 Connection Method .................................................................................................... 138

Chapter 8 Specifications.................................................................................................................................... 140

8.1. Ventilator System ......................................................................................................................... 140

8.1.1. Overall Features ......................................................................................................................... 140

8.1.2. Operating Conditions .............................................................................................................. 140

8.1.3. Non-operating Conditions .................................................................................................... 140

8.1.4. Power Supply ............................................................................................................................... 141

8.2. Ventilator .............................................................................................................................................. 141

8.2.1. General Characteristics ......................................................................................................... 141

8.2.2. Gas Supply ..................................................................................................................................... 141

8.2.3. Patient System Connectors ................................................................................................ 142

8.3. Alarm Setting range ........................................................................................................................... 142

8.4. Ventilation Modes ......................................................................................................................... 143

8.4.1. Controlled Ventilation ............................................................................................................. 143

8.4.2. Supported Ventilation............................................................................................................. 143

8.4.3. Combined Ventilation ............................................................................................................. 143

8.5. Communication / Interface ................................................................................................. 144

8.6. Setting parameter......................................................................................................................... 144

8.7. Equipment characteristics .................................................................................................... 145

8.8. Technical Specification............................................................................................................. 146

8.9. Delivery Accuracy ......................................................................................................................... 146

8.10. Measurement tolerance ........................................................................................................... 147

MV2000 Ventilator System 9 M01-18-L190 Eng. Ver. 4.42


8.11. Performance-SpO2 (optional) ........................................................................................... 147

8.12. Performance-EtCO2 (Optional).......................................................................................... 148

8.13. Test Summary .................................................................................................................................. 149


8.13.1. Guidance and manufacturer’s declaration – electromagnetic emissions
149

8.13.2. Guidance and manufacturer’s declaration ................................................................ 149

- electromagnetic immunity ......................................................................................................................... 149

8.13.3. Guidance and manufacturer’s declaration – electromagnetic immunity


150

8.13.4. Recommended separation distances ............................................................................ 151

Chapter 9 Configurations/Optional accessories ......................................................................... 152

9.1. Basic configurations ................................................................................................................... 152

9.2. Optional Accessories ........................................................................................................................ 153

Chapter 10 Sales and Service Information ...................................................................................... 155

For other technical information, refer to the service manual

The service manual contains the following information:


Provides information to MEKICS-trained service technicians for use when testing,
trouble-shooting, repairing, and upgrading the ventilator. This chapter contains the
following: • Symbol definitions • Safety Information, including Warnings, Cautions, and
Notes • Technical assistance information • How to access on-screen Help • How to
access warranty information • Serial number interpretation • Information regarding
Electromagnetic susceptibility

MV2000 Ventilator System 10 M01-18-L190 Eng. Ver. 4.42


Introduction
A. Device Outline
This chapter provides guidelines for correct use of the product and summarized
information on the MV2000 ventilator.

i. Device Illustration

① ①

② ②

ii. Device Configuration


MV2000 ventilator is composed of the following.
1) User Interface
- Configures ventilation mode and displays patient measurement data with
alarms
2) Main Body
- Mixes supplied gas
- Delivers and exchanges gas

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

3. Intended patient population

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

MV2000 Ventilator System 11 M01-18-L190 Eng. Ver. 4.42


* Patient state: N/A
* Intended part of the Body: Respiratory tract, Mouse and Nose
iv. User
They should only be operated by properly trained clinical personnel, under the
direction of a physician.

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

vi. Service guideline

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.

vii. Exceptions for Legal Responsibilities


- Inappropriate environment
Our company is not responsible for safe operation of MV2000 ventilator if
environment described in this Manual is not followed.
- Service by a non-professional
If this product is serviced or repaired by an individual who did not complete relevant
training, our company is not responsible for safe operation of MV2000.

viii. Side Effect


- Bacteria can more easily get inside the lungs
- Sinus infection: This is more common when tubes are placed through the nose/mouth
- Collapsed lung- air pressure in the lungs can injure the tissue.
- Side effects of medication – medications may be needed to sedate the patient and carry their
own risks.
- Oxygen toxicity-high levels of oxygen can damage lung tissue.
- Damage to the vocal cords.

B. Warning, Caution, Important and Reference Matters


Symbols are indicated 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.

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.

MV2000 Ventilator System 12 M01-18-L190 Eng. Ver. 4.42


CAUTION
Cautions alert users to exercise appropriate care for safe and effective use of
the product.

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

1) Do not store the product in a place exposed to humidity.

2) Do not store the product in a place exposed to direct sunlight.

MV2000 Ventilator System 13 M01-18-L190 Eng. Ver. 4.42


3) Do not store the product in a place near a heating device.

4) Do not store the product in a place with extreme thermal variation.


(Proper Temperature range is -20℃~70℃ and humidity range is 0%~95%)

5) Do not store the product in a very humid place or in a place with poor
ventilation.

6) Do not install or place the product where it may fall or be dropped.


Do not store the product in a place that may cause the patient any harm.
Do not store the product in a place where the product could be exposed
to extreme impact or vibration.

7) Do not store the product in a place where the product could be exposed
to chemicals or explosive gases.

8) Be careful to prevent dirt, especially metal materials, from getting inside


the product.

9) If the product dysfunctions, do not disassemble the product yourself.


Only MEKICS’ service personnel and designated service technicians are
authorized to disassemble the product for repair or battery replacement. If
you disassemble the product yourself, you will not receive any service for
the product.

10) Turn off the product when you will not be using the product for a while.

iii. Cautions for Use


WARNING
1) This product is extremely dangerous when used or stored in places exposed to
chemical substances or explosive gases.
2) Battery may explode when using the product under flame or high temperature.
3) Do not disassemble or dismantle the product. Our company will not take any
responsibility on disassembled products.
4) Read this manual prior to use and check settings for various sensors and devices.
This product should only be used by an authorized individual with sufficient
knowledge about patient monitoring devices.

MV2000 Ventilator System 14 M01-18-L190 Eng. Ver. 4.42


5) The product must be verified regularly to check for accurate operation.
6) Do not use one product on two patients simultaneously.
7) Do not use in places exposed to humidity.
8) It is extremely dangerous to use the product with wet hands.
9) Do not use the product under direct sunlight.
10) Do not use the product in places with large temperature fluctuations.
Temperature range is 10C ~ 40C and humidity range is 10% ~ 90%.
11) Do not use the product nearby electric heating devices.
12) Do not use the product under high humidity or ventilation problem.
13) Do not use the product in places with excessive impact or vibrations.
14) Take care to prevent dusts, especially metal substances from entering the product.
15) Do not use for inhalation anesthesia.
16) The responsible organization is responsible for ensuring the compatibility of the
ventilator and all of the parts used to connect to the patient before use.

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.

MV2000 Ventilator System 15 M01-18-L190 Eng. Ver. 4.42


NOTE

Endotracheal suctioning is a component of bronchial hygiene therapy and mechanical


ventilation and involves the mechanical aspiration of pulmonary secretions from a patient
with an artificial airway in place.
When utilizing a closed-suction catheter system, the suctioning procedure can be executed
using existing mode, breath type, and setting. To reduce potential for hypoxemia during
the procedure, elevated delivered oxygen can be enabled using the elevate oxygen control.
After closed-suction catheter, the elevated oxygen control adds a percentage of Oxygen to
the breathing mixture for two minutes.

iv. Cautions for Electrical Safety


WARNING
1) The rated power input for this product is 100-230 VAC, 1A, 50/60 Hz.
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.

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.

MV2000 Ventilator System 16 M01-18-L190 Eng. Ver. 4.42


WARNING
1) A strong electromagnetic wave may affect the performance of the product.
2) 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
3) If used by a patient with pace maker, a professional individual with all required
expert knowledge must operate the product.
4) Electromagnetic waves generated from an MRI device may influence the
measurement values of the product.
vi. Warnings Regarding Environment of Use
WARNING
1) Do not position the ventilator next to anything that blocks or restricts the gas
inlet or gas exhaust port, fan intake, or alarm speaker, as this may.
- limit the air circulation around the ventilator, potentially causing over-heating.
- limit the ventilator’s ability to exhaust patient exhaled gas leading to potential
harm
- limit the clinician’s ability to hear ventilator alarms.
2) To avoid injury, do not position the ventilator in a way that makes it difficult to
disconnect patient.
3) To ensure proper operation, do not position the ventilator in a way that makes it
difficult to access the AC power cord.
4) Do not use the ventilator in a hyperbaric chamber. It has not been validated for
use in this environment.
5) Do not use the ventilator in the presence of strong magnetic fields. Doing so
could cause a ventilator malfunction.
6) Do not use the ventilator during radiotherapy (i.e. cancer treatment using
ionizing radiation), as doing so could cause a ventilator malfunction.
7) To avoid the risk of ventilator malfunction, operate the ventilator in an
environment that meets specifications.
8) In case of ventilator failure, the lack of immediate access to appropriate
alternative means of ventilation can result in patient death. An alternative
source of ventilation, such as a self-inflating, manually-powered resuscitator (as
specified in ISO 10651-4 with mask) should always be available when using the
ventilator.
9) The ventilator breathing systems, their parts and accessories are validated for
use with MEKICS ventilators.
vii. Warnings Regarding Hoses, Tubing, and Accessories
WARNING
1) 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.
2) Adding accessories to the ventilator can change the pressure gradient across the
ventilator breathing system (VBS) and affect ventilator performance.
Ensure that any changes to the ventilator circuit configurations do not exceed the

MV2000 Ventilator System 17 M01-18-L190 Eng. Ver. 4.42


specified values for circuit compliance and for inspiratory or expiratory limb total
resistance.
3) Use of a nebulizer or humidifier can lead to an increase in the resistance of
inspiratory and expiratory filters. Monitor the filters for increased resistance or
blockage.
4) During transport, the use of breathing tubing without the appropriate cuffed
connectors may result in the circuit becoming detached from the ventilator.
5) The added gas from an external pneumatic nebulizer can adversely affect
spirometry, delivered O2%, delivered tidal volumes, and breathing triggering.
Additionally, aerosolized particulates in the ventilator circuit can lead to an
increase in expiratory filter resistance.
6) To avoid liquid entering the ventilator, empty the expiratory water trap before
fluid reaches the maximum fill line.
7) Always use filters designed for use with MEKICS Ventilator. Do not use filters
designed for use other ventilators
8) Accessory equipment connected to the analog and digital interfaces must be
certified according to IEC 60601-1. Furthermore, all configurations shall comply
with the system standard IEC 60601-1.

viii. Warnings Regarding Gas Sources


WARNING
1) Do not use nitric oxide, helium or mixtures containing helium with the ventilator. It
has not been validated for use with these gas mixtures.
2) To avoid the risk of ventilator malfunction, do not use the ventilator with anesthetic
gases.
3) For Proper ventilator operation, use only clean, dry, medical grade gases when
ventilating a patient.
ix. Warnings Regarding Fire Hazards
WARNING
Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich
environment accelerates combustibility.

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

MV2000 Ventilator System 18 M01-18-L190 Eng. Ver. 4.42


Replacement of ventilator batteries by inadequately trained personnel could result in an
unacceptable risk, such as excessive temperatures, fire, or explosion.

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.

MV2000 Ventilator System 19 M01-18-L190 Eng. Ver. 4.42


xi. Equipment Symbols

1. Symbols on outside of the box


The following table describes the symbols shown on the ventilator shipping cartons.
Table 1.1 Shipping Carton Symbols and Descriptions
Symbol Description

CE Mark 2460: Signifies compliance with Medical Device Directive


93/42/EEC

Use no hook

This side up

Keep dry

Fragile

Maximum number(2) of identical transport package

Maximum number(10) of identical transport package.

Atmospheric pressure limitations: 70 kPa to 106 kPa (10.2 psi to


15.4 psi)

Humidity limitations: 0% to 95% relative humidity, non-condensing


(transport and storage)

Temperature limitations: -20°C to 70°C (-68°F to 158°F) (transport


and storage)

Recovery/recyclable

Serial number
Carton number

MV2000 Ventilator System 20 M01-18-L190 Eng. Ver. 4.42


Model identification notation

MV2000 Ventilator System 21 M01-18-L190 Eng. Ver. 4.42


Chapter 1 Introduction
The MV2000 ventilator is a ventilator that is operated with servo-controlled
software. The range of use of this device is from newborn to adult.
The innovative user interface of this unit offers convenient user accessibility and
maximum versatility. The user interface is a flat color LCD, easy to use with a
touch screen, real-time graphics and monitoring values are arranged to easily
understand the patient's condition, buttons and dials arranged around the screen,
and it is arranged so that setting values can be easily changed and confirmed.
The innovative gas supply engine adopted in this unit realizes the previous
generation of active inspiration and expiration of the servo control method which is
remarkably improved.

1.1 MV2000 Series


Item MV2000
V-ACV ○
P-ACV ○
SIMV ○
SPONT ○
Apnea Backup ○
Mask Ventilation

(Non-Invasive)
PRVC ○
tBiLevel ○
AutoVent ○
HFV(SHFV/DHFV) Option
O2 Stream

(with Nasal Cannula)
TCPL ○
Hemodynamics
Option
(with SpO2 and EtCO2)
Proximal Sensor
Option
(Adult & Neonate)

1.2 Some MV2000 Features

1.2.1 Predicted Body Weight


When if PBW function being used, the single ventilation amount of mechanical
ventilation is determined to Predicted Body Weight formula based on selected patient's
category and gender. The default setting value is 8 ml/kg. This value can be changed in
the BWF (Body weight factor) field in the SYSTEM column of the active window. When
operated with PBW turned on, the setting value of the once ventilation amount is limited
according to the set patient's height and gender’s BWF setting.

MV2000 Ventilator System 22 M01-18-L190 Eng. Ver. 4.42


1.2.2 Full range of Patient Size
This device can be used for adult (male, female), pediatric, and neonate. If user
selected one of patient category in the patient setting window, all operations of
the device can be selected and adjusted only for the functions of the selected
patient.

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.

1.2.3 Leak Compensation


This function compensates for baseline leaks between the patient and the mask,
and between the patient and the airway tube. Flow control valve (FCV) and
Exhalation Valve (ExV) operate to complement each other for maintain PEEP
during exhalation. This function can be used by select the MASK ON in the
SYSTEM column of the setup window. When the leakage amount changes, the
triggering sensitivity is maintained because the base flow is re-set in
consideration of the leakage amount. The maximum leak compensation is 25
LPM.
Range: Off/On
Default: On

- 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

MV2000 Ventilator System 23 M01-18-L190 Eng. Ver. 4.42


 Vt_diff: Differential tidal volume of (Vt_ins-Vt_Exp)
 Vt_diffAvg: Average differential tidal volume of (Vt_ins-Vt_Exp) of few
breaths.
 Vt_leakAvg: Average leak tidal volume of few breaths.
 FLEAK_Avg: Average Leak Flow of few breaths.
 TRR_Avg: Average time of Respiration of few breaths.
 Paw_Avg: Average Paw of few breaths.

- FLEAK(Paw) ; Formula of Leak flow by Paw


- Calculation of FLEAK(Paw) and FLEAK_Avg
F_pat = F_ins – F_exp – F_leak - (1)

Assuming several patient breaths, the following relationship holds.

Vt_diffAvg = FLEAK_Avg - (2)


FLEAK_Avg = Vt_diffAvg / TRR_Avg - (3)
FLEAK_Avg = FLEAK (Paw_Avg) - (4)

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.

F_pat = F_ins – F_exp – FLEAK (paw) - (5)


Vt_pat = Vt_ins - Vt_exp - Vt_leak - (6)

Applied this formula bring to stable synchrony and accuracy flow and volume measuring.

- Examples of working principles

MV2000 Ventilator System 24 M01-18-L190 Eng. Ver. 4.42


1.2.4 Circuit Compliance Compensation
This function compensates for the volume lost by the voluntary nature of the patient
circuit in all volume controlled or targeted breaths (VCV, PRVC).
This feature applies to adults, children, and newborn babies.
The measurement of expiration volume will show the actual patient expiration taking
into account this compliance in all ventilation modes.
Range: Compliance: 0.3 to 3.5 ml/cmH2O
Resistance: 3.0 to 50 cmH2O/LPS
Default: 0.0 ml/cmH2O & 0.0 cmH2O/LPS
Patient circuit compliance & resistance is automatically measured when a calibration is
performed on the ‘Circuit Check’ screen.

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.

1.2.5 ET Tube (Artificial airway) compensation


When ET tube (Artificial Airway) Compensation is turned on, the ventilator automatically
calculates the pressure drop across the endotracheal tube, then adjusts the airway
pressure to deliver the set inspiratory pressure to the distal (carina) end of the
endotracheal tube. This calculation takes into account flow, Fraction of Inspired Oxygen
(FiO2), tube diameter, length, and pharyngeal curvature based on patient size
(Neonatal, Pediatric and Adult). This compensation only occurs during inspiration
period. ET tube (Artificial Airway) Compensation is active in all Pressure Support and
Flow Cycled Pressure Control Breaths.

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.

With an inspiratory pressure setting of zero, ET tube (Artificial Airway) Compensation


will still provide an elevated airway pressure, which will compensate for the resistance
of the endotracheal tube.
When turned on the ET tube (Artificial Airway) Compensation indicator will appear in all

MV2000 Ventilator System 25 M01-18-L190 Eng. Ver. 4.42


modes of ventilation even though the function may not be active (i.e.: Volume
Controlled Breaths). This is to alert you to the fact that Artificial Airway Compensation
will become active if a Pressure Support or combination mode (e.g. Volume Control
SIMV) is selected.
Range: Off/100%~10%
Default: Off

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

MV2000 Ventilator System 26 M01-18-L190 Eng. Ver. 4.42


 The Formula of Vapor pressure[mmbar] vs Temperature
Under 14℃, PVAP[mmbar] = 0.71857 x T[℃] + 6.23

Over 14℃, PVAP[mmbar] = 0.0419 T[℃] x T[℃] - 0.6584 x T[℃] + 13.955

 BTPS and Ambient Pressure correction ;


 Temperature correction
Cf_Temp = (273℃ + T_exp [℃])/(273 + T_ins[℃]).
T_ins is measured, T_exp = 37℃

Cf_Temp = 310 / (273 + T_ins[℃]).

 Vapor pressure (Humidity ) & Ambient Pressure Correction


Cf_Vapor = (Pamb + Pvapor_Exp)/(Pamb + Pvapor_Ins):
Here, Inspiratory Gas is Dry, Pvapor_Ins =0.

Cf_Vapor = (Pamb + Pvapor_Exp)/Pamb

 Cf_BTPS = Cf_Temp x Cf_Vapor

- BTPS (body temperature Pressure saturated): “Auto Humid”


MV2000 System display the values to be converted to saturated volume and flow
by body temperature (37℃ and 100% relative humidity), ambient pressure of sea
level (0 meter altitude).

V_deivery = V_setting/(Cf_BTPS x Cf_amb)


Ex) MV2000 has a sensor for measuring Inspiratory Gas temperature, if the
temperature is 21C.
Pamb = 0.7 atm (approx. 2,500m) V_setting = 500ml
Cf_BTPS = (273+37)/(273+21)*(1033*0.7 + 64)/(1033*0.7 + 25) = 1.109391
V_deivery = 500/Cf_BTPS = 450.7ml

- “Auto-Dry”, Off BTPS: It means ATPS , Ambient Temperature Pressure Saturated


MV2000 System display the values to be measured volume and flow without BTPS.

MV2000 Ventilator System 27 M01-18-L190 Eng. Ver. 4.42


Chapter 2 Unpacking & Setup
2.1 Ventilator Assembly & Setup

2.1.1 Appearance Symbol

Table 2.1 Ventilator main body outside Label or Panel Symbols and Descriptions
Symbol Description

Brand name label

Inspiration gas outlet port. Connect to patient circuit

Nebulizer connection port

Micro-pump nebulizer connection port

Attention, consult accompanying documents


This symbol indicates that user must consult
accompanying document (User’s Manual) prior to
operation.

Exhaust port. Do not place objects that may be blocked


or obstructed in close proximity.

Exhalation Valve Assembly Lock/Unlock

Patient circuit exhalation limb connection port

Proximal flow sensor connection port

Proximal flow, auxiliary sensor connection port

SpO2 sensor connection port

MV2000 Ventilator System 28 M01-18-L190 Eng. Ver. 4.42


EtCO2 sensor connection port

Heater –Heater heats the Exp. part during ventilation to


prevent moisture. Be careful about high temperature
heat.

RS232 / Serial Port –This symbol indicates data


communication connection.

Monitor Connector –This symbol indicates connection to


user interface and cable.

Power On/Off –These symbols are used in power switch.

Indicates power On. Indicates power Off.

EXT. BATT – This symbol indicates external battery.

This symbol indicates external power (AC) connection


part.

Equipotentiality–This symbol indicates terminal that does


not require ground potential for connecting system parts
to create equipotentiality.

Ground

High pressure oxygen connection port for oxygen supply

Compressed air connection port for air supply

Means for "Do not place an objects in this area that


may be blocked or obstructed in close proximity".

This means locate and attention mark for “battery


replacement”.

MV2000 Ventilator System 29 M01-18-L190 Eng. Ver. 4.42


An obstruct sign in air and oxygen hose.

Refer to accompanying documents

No pushing the ventilator with cart.

use separate collection for waste electrical and


electronic equipment(WEEE)

This means CE mark.

IP21 :Finger or similar objects(Effective against > 12.5


mm), Dripping water (vertically falling drops)

Single Use Only

2.1.2 Items Required for Ventilator Setup


The ventilator supplies with the following package contents. Depending
upon the ventilator and components purchased, your list may vary.

1 x Graphical User Interface (LCD unit)


1 x Gas Delivery Unit
1 x Exhalation valve assembly
1 x Gas hoses (1 x Air and 1 x Oxygen)
1 x Mobile cart
1 x Power cord
1 x User Manual, CD or Booklet

MV2000 Ventilator System 30 M01-18-L190 Eng. Ver. 4.42


2.1.3 Power Source
The MV2000 can use the normal power 100-230 VAC, 1 A, 50/60 Hz power
supply, 12 VDC / 7Ah internal battery and optional 12 VDC / 10 A external
battery.

2.1.4 Oxygen/Air Supply


Compressed (high pressure) Air and Oxygen gases must use medical gases and
the inlet pressure are within the range of 241 ~ 620 kPa (35 ~ 90 psi).

Pressure Range: 241 ~ 620 kPa (35 to 90 psi)


Temperature: 10 to 40°C
Minimum Flow: 60 L/min at 40 psi (280 kPa)

Oxygen/Air Inlet fitting ISO7396-1:2007 Compatible


CGA DISS-type body, No. 1240. NIST fitting per BS-5682:1984 (O2) also
available
CGA DISS-type body, No. 1160 (Air). NIST fitting per BS-5682:1984 (Air)

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.

MV2000 Ventilator System 31 M01-18-L190 Eng. Ver. 4.42


2.1.5 Assembling the Ventilator
If you are installing the MV2000 [EVO5] on the mobile cart, refer to the installation manual of
mobile cart and place the main unit in the right position on the mobile cart as shown figure 2.1
and fix it by locking lever.

Figure 2.1 Base attachment

CAUTION
The weight of the ventilator main body is approx. 50 kg. Be careful when installing.
2.1.6 User interface connection method

Figure 2.2 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.

MV2000 Ventilator System 32 M01-18-L190 Eng. Ver. 4.42


2.1.7 Setting up the Exhalation Valve Block
Assembling the Exhalation Valve Block

Turn the water bottle to the right to insert it to the Exhalation Valve block as
shown figure 2.3.

Figure 2.3 Attaching the Collection Bottle to the Water Trap

Insert the valve membrane and flow sensor as shown figure 2.4.

Valve membrane Flow sensor

Figure 2.4 Attaching the Valve membrane and Flow sensor

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.

Figure 2.5 Attaching the Exhalation Block

MV2000 Ventilator System 33 M01-18-L190 Eng. Ver. 4.42


Connect the Patient Circuit

2.1.7.1 Patient Circuit using Humidifier


When using active heated humidifier, connect as shown in the figure, but
be careful not to twist or break the hose.

Push down and Lift up the top cap of


Fill the distilled
press the the chamber to
water to chamber
humidifier holder separate them.
using nipple port.
to chamber.

Check the limited Connect the Inspiration


line of chamber Circuit and Chamber.
Figure 2.6 Patient Circuit with Active Humidifier

2.1.7.2 Patient Circuit with humidifier

In order to connect the non-heater wire


Dual Limb Circuit as below

Figure 2.7 Patient Circuit without active humidifier.

MV2000 Ventilator System 34 M01-18-L190 Eng. Ver. 4.42


WARNNING
Antistatic or electrically conductive hoses or tubing are not to be used in the
VENTILATOR BREATHING SYSTEM.

2.2 Front Panel Connections

A1. Nebulizer port


A2. Inspiration Outlet
A3. Expiration Outlet
A4. Expiration Inlet
A5. Handle for Moving
A1 A2 A6. SpO2 Connector
A7. EtCO2 Connector
A8. Proximal flow sensor port (Option: Esophageal
Pressure & Tracheal Pressure Port)
A8

A5
A3 A4 A6 A7

Figure 2.8 Front Panel Configurations

2.2.1 Connect the Nebulizer


The MV2000 ventilator can be used by connect the nebulizer to the intake circuit
Nebulizer operates synchronized with inspiratory phase, and when you press the
operation button once, the remaining operation time is displayed at the bottom
of the operation button. The operating time can be adjusted at the Nebulizer
function in the SYSTEM column after activating the setup window. If you have
also selected the Aerogen nebulizer as an option, you can select the Nebulizer
type in the SYSTEM column after activate the setup window.

CAUTION
A change in the flow rate due to the use of this nebulizer may affect the patient's tidal
volume.

2.2.2 How to connect SpO2


① Connect the SpO2 sensor cable to the socket with the SpO2 label on the right
side of the MV2000 ventilator.
② Place your finger on the SpO2 sensor.
③ When you select the SpO2 graph from the graph selection menu, the measured
value is displayed.

MV2000 Ventilator System 35 M01-18-L190 Eng. Ver. 4.42


2.2.3 How to connect EtCO2

① MV2000 connect the EtCO2 sensor cable to the socket labeled EtCO2 on the
right side of the ventilator

② Connect the IRMA analyzer to the "Gas Extension Cable".


③ Fit the airway adapter to the IRMA probe as shown below.

④ When the green LED on the IRMA probe is displayed, it is ready for use.

MV2000 Ventilator System 36 M01-18-L190 Eng. Ver. 4.42


⑤ Connect the IRMA / airway adapter 15 mm male connector to the breathing
circuit Y-piece.

⑥ Connect the IRMA / airway adapter 15 mm female connector to the patient


endotracheal tube.

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.

MV2000 Ventilator System 37 M01-18-L190 Eng. Ver. 4.42


⑦ Connect the EtCO2 sensor to the patient
- When connecting IRMA probe to an infant patient circuit it is important to avoid
a direct contact between the IRMA probe and the infant's body.
- 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.

⑧ Measurement values are displayed by selecting EtCO2 graph from Graph


Selection menu.

2.2.4 Connect the Proximal Flow Sensor


In MV2000 ventilator, "Proximal flow sensor" can be installed to measure airway
flow. Connecting to terminal A8 in the above figure, airway flow measurement
and alarm function can be used. You can also measure Esophageal & Tracheal
Pressure according to the end accessory you connect.

2.2.5 Esophageal Balloon (Option)


The MV2000 ventilator can measure the pressure of the esophageal balloon. This
sensor is connected to the left connection terminal of the Proximal flow sensor
connection terminal. To activate it, the Esophageal pressure should be turned on
in the SYSTEM column of the setup window.

NOTE
See chapter * for placement technique for esophageal balloons.

2.2.6 Tracheal Catheter (Option)


The MV2000 Ventilator can measure Tracheal pressure. This sensor is connected
to the right connection terminal of Proximal flow sensor connection terminal. To
activate it, Tracheal pressure should be turned on in the SYSTEM column of the
setup window.

NOTE
See chapter * for placement technique for esophageal balloons.

MV2000 Ventilator System 38 M01-18-L190 Eng. Ver. 4.42


2.3 User Interface Rear Label or Panel Symbols

Table 2.3 User Interface Rear Label or Panel Symbols and Descriptions

Symbol Description

Manufacturing date

List the serial number of the equipment.

Mounting slot for Micro SD card


It is the HDMI connecting part for external screen output

External storage USB connection.

LAN connection port


Force restart button on the device
Connect with main body

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.

MV2000 Ventilator System 39 M01-18-L190 Eng. Ver. 4.42


Connectors


36Pin connector


OTG USB Port

③ 10/100 MB LAN
HOST USB Port

① 36Pin Connector ( Monitor to Main Body)

18
36 1
19

Pin No. Define Function


1,2,20,19 Power source(DC 15V) Power is supplied from the Main Body.
3,21 Power source(DC 5V) Power is supplied from the Main Body.
5,18,36 GND Monitor PCB GND (Ground) Pin for BD.
23 EXT Batt Power to turn on battery LED when using battery
6,24 Main SW Pin related to PWR Switch located on front of Monitor
25 EXT POWER Power to turn on the power LED when using AC power
Pin for communication with Pneumatic PCB, Pin for
8 PNEU_TX
transmitting data from Pneumatic to Monitor
Pin for communication with Pneumatic PCB, Pin for
9 PNEU_RX
receiving data from Monitor at Pneumatic.

MV2000 Ventilator System 40 M01-18-L190 Eng. Ver. 4.42


Pin for communication with SpO2 module, Pin for
26 SpO2_TX
transmitting data from SpO2 module to Monitor
Pin for communicating with SpO2 module, Pin for receiving
27 SpO2_RX
data from Monitor in SpO2 module
Pin for communication with EtCO2 module, Pin for
16 EtCO2_TX
transmitting data from EtCO2 module to Monitor
Pin for communication with EtCO2 module, Pin for
17 EtCO2_RX
receiving data from Monitor in EtCO2 module

② OTG(On The Go) USB Port


This port is a pin for connecting Monitor F / W with USB to PC and download tool.

③ Host USB Port


This port is a port that can transmit or receive data from memory or storage device in the
Monitor by connecting to PC via USB.

④ 10/100 Mbit LAN


This port is for wired LAN communication through RJ45 cable, and it is a port for connecting
MV2000 to MP601 (MEKICS PC base central monitoring system).
Please note that the routers or hubs currently available in the market automatically support
Gigabit LANs, so in some cases you may need to configure the router or hub settings to
10/100 Mbit .
MV2000 Monitor supports only 10/100 Mbit LAN.

5 6

⑤ MicroSD Card Port


This port is for using MicroSD Card.
Anyone can upgrade Monitor F / W easily with MicroSD Card.
Please refer to the service manual provided separately for the upgrade method of Monitor
F / W using MicroSD Card

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.

MV2000 Ventilator System 41 M01-18-L190 Eng. Ver. 4.42


2.4 Back Panel of Ventilator main body

B9 B8

B2 B3 B4

B5 B6
B1

B7

B10
B11

Figure 2.9 Rear panel


B1. External Battery Port
B2. Main Power Switch
B3. AC Power Inlet
B4. Ground Terminal
B5. Air Gas Inlet
B6. O2 Gas Inlet
B7. Water Trap
B8. Connector between Screen and Main Body
B9. RS232 Communication Terminal
B10. Tank Safety Air Relief
B11. Battery Cover

NOTE
The ventilation system does not contains latex.

MV2000 Ventilator System 42 M01-18-L190 Eng. Ver. 4.42


2.5 Setting system

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.

2.5.1 Setup menu

2.5.2 SYSTEM decision items

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

MV2000 Ventilator System 43 M01-18-L190 Eng. Ver. 4.42


C. O2 Boost Neonate
Set O2 concentration of neonate 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 3 minute period, the maneuver
is cancelled and the ventilator will return to prior settings.
Defaults: +20% Neonatal
Neonate: 20% above the set % O2 or 100%, whichever is less

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

G. Proximal Flow and Pressure Sensor


 Volume correction is important to the patient. In case of smaller volumes are
especially important.
- Proximal flow sensor can be solved problem the measurement of smaller volumes.
- Setting value: OFF
P.on F.off: Proximal Pressure On, Proximal Flow OFF
P.on F.on: Proximal Pressure and Flow ON

- Connect the blue tube to the left connector of the above figure.

MV2000 Ventilator System 44 M01-18-L190 Eng. Ver. 4.42


- Connect the flow sensor between the Y-piece and the breathing circuit. Connect the
blue line to the near side of the patient

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.

BTPS: temperature and altitude of the sea correction

STPD: altitude of the sea correction

I. ET Tube (Artificial airway) compensation ON/OFF


- Turn on or off the ET tube (Artificial airway) compensation 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.

L. Tube (Patient circuit compliance) Compensation


- Select whether to use the Tube (Patient circuit compliance) Compensation function.
For Neonate patients, it is recommended to set the tube calibration function to Off and
use or use the Proximal sensor.

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

MV2000 Ventilator System 45 M01-18-L190 Eng. Ver. 4.42


- Set the CO2 unit.
- Unit of measure value:% or mmHg

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.

2.5.3 Patient menu

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)

MV2000 Ventilator System 46 M01-18-L190 Eng. Ver. 4.42


E. PORT
- Enter the port number for external connection using LAN.

F. System information
- Information on Main and Pneumatic SW Version, ventilator working time, O2 remaining
amount.

2.5.4 Calibration menu

It is calibrated the used sensors in MV2000.

2.6 Sensor Calibration


If you continue to use the ventilator for a long period of time, the measured values may
vary slightly, so you should calibrate the measurement sensors.

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.

- How to calibrate a measurement sensor:


 Select the User Interface Settings menu. Select Calibration (Cal.) from the submenu.

- The types of calibration are as follows

MV2000 Ventilator System 47 M01-18-L190 Eng. Ver. 4.42


 Circuit Chk.
(Circuit Check)
 INS-EXP
(Exhalation Flow Auto Calibration)
 FiO2 Cell Cal.(O2 Sensor)
(O2 Cell Calibration)
 Exp. Flow Gain :
(Expiratory Flow Sensor Balance)
 Adult Prox. Flow Gain
(Adult Proximal Flow Sensor Balance)
 Neo. Prox. Flow Gain
(Neonate Proximal Flow Sensor Balance)
 EtCO2 Zeroing (EtCO2 Module)
 EtCO2 SetO2 (EtCO2 Module)
 EtCO2 NO2O (EtCO2 Module)

2.6.1 Circuit Check


Analyze circuit leaks, compliance and resistance.

The "Circuit Check" is performed as follows.


1. Measuring circuit resistance
30LPM for 2 Seconds.

1 second InsFlow, InsPrs, ExpPrs Cumulative average


circuit_R [cmH2O / LPS] = (60 * (InsPrs - ExpPrs)) / InsFlow
for circuit_R_ control [cmH2O / LPS] = circuit_R * 4
Available circuit_R is 3cmH2O / LPS to 50cmH2O / LPS

2. Measure circuit compliance


5LPM for 3 Seconds.
Close PEEP with 50cmH2O while 5LPM is flowing
If ExpPrs does not exceed 50 cmH2O,
If you cannot exceed 3 seconds 15LPM spill
15LPM even if it has passed 50cmH2O
If it exceeds 50 cmH2O,
circuit_C [L / cmH2O] = InsFlow / ExpPrs
Available circuit_C "is 0.3 mL / cmH2O to 3.5 mL / cmH2O

3. Measure circuit leak


After measuring the circuit compliance,
If there is a circuit leak, ExpPrs will drop more and more.
If ExpPrs falls below 40 cmH2O, or if there is a circuit leak or is over 10 seconds
circuit_leak = (circuit_C * pressure drop) / leak measurement time

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.

MV2000 Ventilator System 48 M01-18-L190 Eng. Ver. 4.42


.
2.6.2 Exhalation Flow Auto Calibration
INS-EXP is an automatic Perform adjustment of equilibrium for inspiratory flow
and expiratory flow. Before performing Exhalation Flow Auto calibration,
inspiration port and expiration port must be connected to tube. Calibration starts
by pushing Start button after rotating the encoder.

After initial operation, the following window will appear on the screen. Adjustment
is required if the initial operation or exhalation valve assembly changes.

2.6.3 O2 Cell Calibration


As oxygen (O2) cells are used for a longer time, O2 concentration values measured
due to natural consumption of O2 cells may be wrong. Therefore, O2 concentration
value can be adjusted through calibration. If the 21% menu is selected by turning
the encoder while the air supply is connected, 21% oxygen (O2) calibration starts
and ends after a while. When 100% O2 is supplied, turning the encoder to select
100% menu starts 100% O2 calibration and ends after a while.

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.

2.6.4 Expiratory Flow Gain


Adjustment is made to balance the inspiratory flow rate and the expiratory flow
rate of the system. You can adjust the ratio of volume of inspiration volume to
volume of exhalation.

MV2000 Ventilator System 49 M01-18-L190 Eng. Ver. 4.42


2.6.5 Adult/Neonatal Proximal Flow Gain
Adjusts the balance between Proximal Flow Rate and Inspiratory Flow Rate.
With Proximal sensor connected to the inspiration outlet port, turn the encoder to
select Adult or Neonate according to the correspond menu for the Proximal sensor,
and the calibration will start and finish after a short while.

2.6.6 EtCO2 Zeroing


This function automatically adjusts the offset of the EtCO2 sensor. Rotate the
encoder and press Start to begin calibration and finish after a short while.

2.6.7 EtCO2 Set O2


Set the concentration range of oxygen used. No setup is required if you do not
use EtCO2 Module.

2.6.8 EtCO2 Set N2O


Set the concentration range of N2O used. No setup is required if you do not use
EtCO2 Module.

2.7 Power supply

2.7.1 Outline

MV2000 ventilator has auto transition function for rated voltage. The ventilator
automatically adjusts to 100-230 VAC power.

To prevent damages in ventilator setting and stored information upon suspension


of AC power (main power) supply, power source is automatically converted to 12V
DC power (battery). Check charging status of battery frequently.

NOTE
Battery can’t be replaced, during the use of ventilator.

MV2000 Ventilator System 50 M01-18-L190 Eng. Ver. 4.42


Also, the ventilator can be used by connecting to an external 12V DC power. Here,
similar to internal battery, power source is automatically converted to external
12V DC power upon suspension of AC power supply. Ventilator setting and stored
information are preserved.

2.7.2 Power Supply Specification

Rated voltage range


100-230 VAC, 1 A, 50/60 Hz

Internal battery
Recharge able battery - 12VDC, 7Ah.

External 12V DC power input


12-15 VDC, 10A

2.7.3 Battery Information Summary

Battery Life 1 year form date of manufacture


Quantity 1 EA
Operation Time About 3 hours (if used continuously)
Charging Time About 4 hours
Storage Temperature
15-20℃, 59-68℉
(Individual Storage)

2.7.4 Battery Status Display Screen

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.

Information on battery module inserted in the ventilator is displayed as follows.

Display Status Description


Full Charging Battery charged about 100%
50% Charging Battery charged about 50% above
If the battery power is remaining low, the icon is
displayed on the screen. In order to protect the
Low Charging
battery, beep sound is created and power is
automatically turned off after about 5 minutes.

MV2000 Ventilator System 51 M01-18-L190 Eng. Ver. 4.42


CAUTION
To use the internal battery, AC power should be connected for at least 4 hours. The
operating time with the internal battery is about 3 hours, and the charging status is
displayed in the battery status indicator on the front panel of the unit.

2.7.5 Alarm and Safety Devices

Battery status is always monitored by the ventilator. Check the following


precautions.

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.

2.7.6 AC Power Supply Failure


If there is no AC power supply or power outlet is disconnected, the ventilator
automatically operates using battery.

2.8 Operation Method


2.8.1 Operation Sequence Summary

The following is summarized operation sequence of MV2000 ventilator.

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.

MV2000 Ventilator System 52 M01-18-L190 Eng. Ver. 4.42


Refer to the following section for detailed description on individual sequence of
ventilator operation.

2.8.2 Pre-Use Check


Test and measurement items during pre-use check process are as follows.
A. Gas supply status
B. System function inspection
C. Internal block leakage
D. Pressure sensor
E. Flow sensor
F. Oxygen(O2) cell
G. Battery status
H. Leakage and compliance of patient tube

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.

MV2000 Ventilator System 53 M01-18-L190 Eng. Ver. 4.42


2.8.3 How to start MV2000
A. Connect power and gas supply line.
- AC power
- Air, O2 gas

Rear view/rear panel of Pneumatic module box


B. Turn on the ventilator.

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.

MV2000 Ventilator System 54 M01-18-L190 Eng. Ver. 4.42


③ Once inspection is completed, the stand-by screen will appear.

2.8.4 Automatic switchover Between AC and Battery Power


During pre-use check, auto transition between AC power and battery power from
connected or reconnection of AC power supply must be tested.
- Check icon on the screen to see whether the ventilator is in AC mode.
- Unplug the AC plug to shut off power source.
- Check whether icon is changed to battery mode. If there is no problem in icon
change of battery mode, reconnect the AC plug.

CAUTION
If the product is turned off during switchover to battery mode, re-inspect after charging
or replace the battery.

2.8.5 Inspection of the patient breathing circuit


A. Connect patient breathing circuit including humidifier and nebulizer. If humidifier
is used, humidifier chamber in the humidifier must be filled with distilled water.
B. Block the end of Y-piece and performed as follow the screen instruction. Check for
tube leakage. If the breathing circuit compliance is performed successfully, the
breathing circuit compliance compensation function is activated automatically.

C. Operate the product after connecting test lung to Y piece. Check the status of
patient tubes and ordinary operation.

MV2000 Ventilator System 55 M01-18-L190 Eng. Ver. 4.42


WARNING
To ensure proper compliance and resistance calculations, perform 'Circuit Check' with the
humidifier/humidification chamber and all accessories used for patient ventilation
installed in the ventilator breathing system.

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.

2.9 Default Settings for Adult, Pediatric and Neonate


If you turn on the unit and select "New Patient", the default values are shown in
the table below.

2.9.1 Ventilation Setup: PBW OFF


Pediatric Neonate
Parameter Adult Setting
Setting Setting
FiO2 40% 40% 40%
Common Trigger 3.0 L/min 2.0 L/min 1.0 L/min
PEEP 6 cmH2O 6 cmH2O 3 cmH2O
PS 0 cmH2O 0 cmH2O 0 cmH2O
PSV
Apnea 20 sec 20 sec 10 sec
Backup
Mode PRVC, V-ACV, P-ACV, TCPL-AC
Vent.
Vt 500ml 100ml 5ml
RR 12 bpm 20 bpm 30 bpm
Ti setting 1.0 sec 0.75 sec 0.35 sec
VCV Ins. Pause 0.0 sec 0.0 sec 0.0 sec
EnSENS 70% 70% 70%
F-end 25% 25% 25%
Sigh OFF OFF OFF
Pi 15 cmH2O 15 cmH2O 15 cmH2O
PCV RR 12 bpm 20 bpm 30 bpm
Ti 1.0 sec 0.75 sec 0.35 sec
Vt 500ml 100ml 5ml
PRVC RR 12 bpm 20 bpm 30 bpm
Ti 1.0 sec 0.75 sec 0.35 sec
Pi N/A N/A 15 cmH2O
RR N/A N/A 30 bpm
TCPL
Flow Rate N/A N/A 8 L/min
Ti N/A N/A 0.35 sec

MV2000 Ventilator System 56 M01-18-L190 Eng. Ver. 4.42


Plow 5 cmH2O 5 cmH2O 5 cmH2O
tBiLevel High PS 0 0 0
Low PS 0 0 0
Plow 5 cmH2O 5 cmH2O 5 cmH2O
AwPRV
High PS 0 0 0
AutoVent MinVol % 100% 100% 100%
O2 Stream Flow Rate 30 l/min 10 l/min 3 l/min
FiO2 100 100 100
CPR Trigger OFF OFF OFF
RR 10bmp 10bpm 10bpm

2.9.2 Alarm Setting

Alarm parameters default & auto setting value

Parameter Setting value


VTe High (140% * VTi) or (VTi + 40ml) whichever is greater
For ventilation mode without VTi setting parameter:
-. Adult: 800 ml
-. Pediatric: 160 ml
-. Neonate: 50 ml
# Unit 5 ml

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

MV2000 Ventilator System 57 M01-18-L190 Eng. Ver. 4.42


-. Neonate: 60
RR Low RR - 3 (lowest value 2)
For ventilation mode without RR setting parameter:
-. Adult: 40
-. Pediatric: 50
-. Neonate: 60
Ppeak High 20cmH2O + PEEP + Pinsp
tBilevel, AwPRV: 20 cmH2O + PEEP H
For ventilation mode without Pins setting parameter:
-. Adult: Peep + 30
-. Pediatric: Peep + 40
-. Neonate: Peep + 60
Ppeak Low -15 cmH2O + PEEP + Pinsp
tBilevel, AwPRV: -15 cmH2O + PEEP H
For ventilation mode without Pins setting parameter: PEEP value
For ventilation mode without PEEP setting parameter: 3 cmH2O (Ppeak
Low minimum value)
PEEP High 5 cmH2O + PEEP
Without PEEP Setting value: 15 cmH2O

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.

Adult Pediatric Neonate


Parameter
Setting Setting Setting
High tidal volume (Vte) 5 ~ 2500 mL /
2,500 1,000 300
OFF
Low tidal volume (Vte) 0 ~ 2500 mL 0 0 0

High min volume (Vte, min) 0.1 ~ 50 LPM 30 30 5


Low min volume (Vte, min) 0.0 ~ 49.9
0 0 0
LPM
High respiration rate 3 ~ 180 BPM 75 75 75

Low respiration rate 2 ~ 179 BPM 2 2 2

MV2000 Ventilator System 58 M01-18-L190 Eng. Ver. 4.42


High peak airway pressure 1 ~ 120
40 40 30
cmH2O
Low peak airway pressure 0 ~ 119 cmH2O 8 8 5

High O2 % 19 ~ 100 % / OFF OFF OFF OFF

Low O2 % 18 ~ 100 % OFF OFF OFF


Airway leak 50 ~ 500 mL / OFF OFF OFF OFF

Apnea 2 ~ 60 sec 20 20 10

[ Option, SpO2 ]
High SpO2 52 ~ 99 % / OFF OFF OFF OFF

Low SpO2 51 ~ 99 % 85 85 85

High pulse rate (SpO2) 30 ~ 250 BPM 150 150 150

Low pulse rate (SpO2) 25 ~ 245 BPM 50 50 50

[Option, EtCO2]

High EtCO2 0.0 ~ 15.0 % 6.0 % 6.0 % 6.0 %

Low EtCO2 OFF / 0.0 ~ 14.9 % OFF OFF OFF

High inspired CO2 0.0 ~ 15.0 % 3.0% 3.0% 3.0%

Low inspired CO2 OFF / 0.0 ~ 14.9 % OFF OFF OFF


High respiration rate (EtCO2) 2 ~ 180
75 75 75
BPM
Low respiration rate (EtCO2) 1 ~ 179 BPM 2 2 2

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.

MV2000 Ventilator System 59 M01-18-L190 Eng. Ver. 4.42


Chapter 3 Ventilator Operation
3.1 Ventilator Configuration

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.

① User Interface (Screen)


② Patient Unit (Main Body)
③ Inspiration Outlet ①
④ Expiration Inlet
⑤ Mobile Cart


MV2000 Ventilator System 60 M01-18-L190 Eng. Ver. 4.42


3.2 User Interface Configuration
The icons used in the user interface of the MV2000 ventilator are shown in the table below.

Item Description

User interface ON/OFF or standby button

Alarm silence (2 minutes) button

Alarm reset button

Information button

Accept (enter) button

Cancel button

Nebulizer function icon

Manual breath function icon

O2 boost function icon

Closed Suction function icon

Open Suction function icon

Screen freeze function icon

Screen layout select window open function icon

Tool menu window open function icon

MV2000 Ventilator System 61 M01-18-L190 Eng. Ver. 4.42


Inspiration Hold function icon

Expiration hold function icon

Alarm status or alarm silence remaining time icon

Screen lock/Unlock function icon

System setting window open function icon

Icon indicating that AC power is being operated

Indicating that the battery is in operation, and


displaying the remaining capacity of the battery icon

MV2000 Ventilator System 62 M01-18-L190 Eng. Ver. 4.42


1) Display of current ventilation mode (Touch to open the mode setting window)
2) Alarm Status icon (Touch to open alarm setting window)
3) Alarm message window
4) Nebulizer On/Off display
5) Manual inspiration
6) O2 Boost
7) Closed Suction
8) Open Suction
9) Freeze
10) View – Screen Layout
11) Tool – PV tool
12) Inspiration Hold
13) Expiration Hold
14) Waveform window
Three parameter waveforms, pressure/flow, volume/flow and pressure/volume loop display
15) Measurement value display
16) Pad to add or change setting values
17) I:E value
18) Time, Bed
19) Touch key lock/unlock
20) Setup menu
21) Power Status Icon
22) System On/Off switch
Standby key is used during operation of the product. Standby state is a state in which all
things except the ventilator are turned on.
23) Alarm silence
No alarm sound for 2 minutes.
24) Alarm reset
Reset alarms.
25) Ventilator Information
26) Run(Accept)

MV2000 Ventilator System 63 M01-18-L190 Eng. Ver. 4.42


Execute or run operation
27) Exit (Cancel button)
28) Encoder
Encoder is used to select menu or parameter. Also, encoder is used to adjust values and
save adjusted values by clicking.
29) ALARM LED
30) AC LED
31) Battery LED

Hard keys and LEDs

Figure 3.1 User Interface Module (English) Showing Button

How to set the respirator using the fixed key button


The types of fixed key buttons are as follows.

1) Power, standby mode button


Use to turn on the user interface (ventilator).
You can switch to standby mode while the ventilator is running.
When pressed in standby mode, the ventilator can be turned off.

2) Alarm Silence (2min)


The alarm will not sound for 2 minutes when pressed. Press again within 2 minutes to
disable this function. However, it does not work with VENT INOP alarm.

NOTE
Even if this function is activated, an alarm will be activated again when an alarm
occurs due to another cause.

MV2000 Ventilator System 64 M01-18-L190 Eng. Ver. 4.42


3) Alarm Reset
4) Information
5) Accept
The value changed by the dial operation is applied.
6) Cancel
The value changed by the dial operation is canceled and the original value is applies.
7) Encoder
Uses to change the select/adjust or set value of the touch screen menu and parameters.
8) Alarm LED
9) Power LED
10) Battery LED

3.3 How to use the user interface


The following shows the general usage of the user interface in order.

3.3.1 How to setting the menu or parameter by touch screen.

② ④

Setting method of ventilation mode and parameters:


1) Activate the ventilation mode by pressing the ventilation mode at top of the
screen.
2) Push the parameter to configure and activate it. Once activated, Blue frame is
turned white, and values can then be changed.
3) Rotate the encoder to adjust for intended value, and push the encoder or touch
again the activated parameter window in order to settle adjusted value. When
parameter turned to blue, then new setting value has been save.
4) Push Accept to operate new setting values and Cancel to cancel.

ATTENTION
Do not use sharp-edged instruments or pointed tools when touching the screen.

MV2000 Ventilator System 65 M01-18-L190 Eng. Ver. 4.42


3.3.2 Encoder Setting

Ventilator Setting Using Encoder


1) Rotate the encoder (rotary dial) to position it on the desired menu.
2) Select by push the encoder. Once activated, Blue frame is turned white, and
values can then be changed.
3) Rotate the encoder (rotary dial) and adjust to setting value for desired.
4) Push the encoder or touch again the activated parameter window in order to
settle adjusted value.
5) When parameter turns blue, new setting has been saved. Push Accept to
operate new setting values and Cancel to cancel.

3.3.3 (Direct Access Button) Main setting parameter button

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.

Direct Access Button Use

To adjust the parameters of the ventilation mode:


1) Activate by touching the hot key button for want to change.
2) Set the value using the encoder (rotary dial).
3) Touch again to accept the setting parameter value.

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NOTE
When parameters are changed using direct access button, changed values are applied
since the next breath. Here, there is no button to confirm user’s intentions such as
Accept button on touch screen.

3.3.4 Menu Key

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.

1) Mode - Select the mode and adjust the detailed settings.


2) Alarms –This menu is used to configure various alarms on measurement values.
3) View - Configures screen layout and trend timing (Waveform – Pressure, Flow,
Volume / Loop – P-V, V-F, P-F / Trend – VE MIN, PMEAN, PPEAK, VTE, CL, RA,
iCO2, EtCO2, Resp, PEEP, SpO2, PR).
4) Tools – Uses Insp.Hold, Exp.Hold and PV tool functions.
5) Monitoring – Comprehensively displays data measured in each mode.
6) System - Composed of operational environment settings, input data of patient
information, date correction and various measurement sensor calibration and
settings.

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3.3.5 Status (System Information Window)

The user interface displays system information about the current ventilator.
The types of system information displayed are as follows.

1) Show active ventilation mode


Display of current breath mode. Press for activate the breath mode on selection
window.

2) Alarm display and alarm message window


For more information, please refer to the chapter 7 Alarm section.

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 the pressure is maintained between 12 ~ 15 psi enough to inject drugs.

The available patients or setting ranges are as follows.

- Patient over 8kg in pressure mode

- When setting volume more than 200mL when using volume mode

Micro pump type (optional)


Aerogen's nebulizer is used.

MV2000 Ventilator System 68 M01-18-L190 Eng. Ver. 4.42


Micro pump is operated from 300 ms after start of inspiration to half of inspiration
start (maximum 500 ms after start of inspiration) by using ultrasonic method.
There is no limited patient or setting range when using micro pump type.

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

- Closed Suction support

Perform closed suction support operation. It is used when suction is performed


without removing the patient's circuit. At this time, O2 Boost operates
simultaneously.

- Open Suction support

Perform an open suction support operation. It is used when disconnecting


patient's circuit and performing suction. At this time, O2 Boost operates
simultaneously. With this function, when the patient hose is disconnected, the
ventilation is stopped, only the basic flow is made, and when connected to the
patient, it automatically detects it and starts ventilation automatically.

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7) Ins, Exp Hold

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.

8) I:E ratio, Time, Bed No., Power, Lock/Unlock Indicators

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.

Time: Displays the current time.

Bed number: In-case of link with an electronic chart in Hospital Information


System (or EMR: Electronic Medical Record), the patient bed number displays in
the Patient Column of the setting window
.
Power Status: Displays the type of power source being current use electrical or
battery power. And displayed the remaining battery status when if using battery
power.

Lock/Unlock key: Used to lock or unlock the touch screen.

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.

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3.3.6 Ventilation Mode and Parameter Setting


1) Touch Mode Display Window.


2) Select the mode to use in the activated ventilation mode on display window.
Once a ventilation mode is selected, parameters required for the selected mode
are displayed.
3) Select parameters for which values should be changed, and use the encoder to
adjust their parameter values. After adjusting the parameter, touch again that
parameter window or push the encoder to save the adjusted value.
4) Once setting value is saved, push Accept button to operate with saved value or
push Cancel to cancel.

3.3.7 Alarms setting

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.

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3.3.8 Starting the Ventilation

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
.

3.3.9 Patient Size

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.

PBW Patient size By Setting range


Gender Weight (kg) PBW Formula
Male 25 ~ 150 0.9097 * Height – 88.022 + 0.5
Female 20 ~ 150 0.9049 * Height – 92.006 + 0.5
Pediatric 8 ~ 41 0.29 * Height – 11.2 + 0.5
Neonate 1~15 0.29 *Height – 11.2 + 0.5

3.3.10 Setting the Ventilation Breath Type and Mode

Touch the Mode operation window on the screen to activate the following screen.

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The user can select the ventilation mode to enforce in this display window.
In additionally, all of required parameters, ventilation type and modes are displayed,
and can be change the setting parameters and ventilation type/mode.
The MV2000 ventilator supports the following ventilation modes.
PACV, PSIMV, VACV, VSIMV, Spont, Apnea Back-up ventilation, O2 Stream® , PRVC, Bi-
Level, AwPRV, AutoVent® , TCPL-AC, TCPL-SIMV, PRVC-SIMV, SHFV® , DHFV® , CPR
APNEA Backup is available in all AwPRV/tBi-Level and Spontaneous ventilation modes.

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.

3.3.11 Breath Types


This section contains a brief description of the breath types and ventilation mode
combinations available for adult, pediatric and neonatal patients.
There are two basic breath types:
Mandatory breaths (delivered according to set ventilator parameters) and,
Demand breaths (triggered by the patient)

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All breaths are defined by four (4) variables:
Trigger (initiates the breath),
Control (controls the delivery),
Cycle (primary breath termination), and
Limit (secondary breath termination).

3.3.11.1 Mandatory Breaths


Mandatory breaths can be triggered by the machine, the patient, or the
operator. There are 4 mandatory breath types delivered by the ventilator.
A. Volume breaths, which are:
• Controlled by flow (inspiratory);
• Limited by pre-set volume or maximum inspiratory pressure.
• Cycled by volume, flow, and 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.

 Automatic flow rate increase function: maintains or increases the flow


rate so that the inspiratory effort of the patient is larger than the flow
rate set by the patient, so as not to interfere with the inspiratory effort
of the patient.
 Automatic extension of the inspiration time and the progress of the
evacuation function: Even if the inspiration time of the patient's
inspiratory effort exceeds the set inspiratory time, it can be maintained
without stopping. In this case, the patient's expiratory effort begins, or
if the inspiratory effort is reduced enough, the expiration process.
 Exhalation time guarantee function: If the patient's effort increases the
inspiratory time, the expiration time is guaranteed to be longer than the
inspiration time.

B. Pressure breaths, which are:


• Controlled by pressure (inspiratory + PEEP);
• Limited by pressure (inspiratory + PEEP + margin);
• Cycled by time or flow.

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C. Time Cycled Pressure Limited (TCPL) breaths (available for
neonatal patients only), which are:
• Controlled by inspiratory flow;
• Limited by pressure (inspiratory + PEEP);
• Cycled by time, flow (inspiratory), or volume (Volume Limit).

NOTE
TCPL breath type is only available for Neonates. This is the default breath type for
neonate patients.

- Pressure Regulated Volume Control (PRVC) breaths are


pressure breaths where the pressure level is automatically modulated
to achieve a preset volume.
• Controlled by pressure (inspiratory + PEEP) and volume;
• Limited by pressure (inspiratory + PEEP + margin);
• Cycled by time or flow.

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.

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A. PEEP + 16cmH2O or Setting When the tidal volume is reached, the first breath
is stopped.
After that, from the second breath, the pressure mode is executed for the set
inspiratory time.

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.

3.3.11.2 Demand Breaths


All demand breaths are patient-triggered, controlled by pressure, and flow or
time cycled. Demand breaths can be either pressure supported (PSV) or
spontaneous. All demand breaths are displayed in red on the Flow wave form
graphic.

- PSV (Pressure Support Ventilation)


A PSV breath is a demand breath in which the pressure level during
inspiration is a preset PSV level plus PEEP.
PSV pressure can be set from 0cmH2O.
PSV breaths are:
• Controlled by pressure (preset PSV level + PEEP);
• Limited by pressure (preset PSV level + PEEP)
• Cycled by time (PSV Tmax) or flow (PSV Cycle).
Pressure assisted breathing can be selected in Spont or AwPRV / Bi-Level
ventilation mode.
- Spontaneous breath
Only the PEEP level is maintains, and start, maintain and terminate by the
patient breaths cycle.

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.

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Figure 3.11 PSV Waveform

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.

If the expiratory volume does not reach to En_Sense[%] of Vins


(Supported Volume), the Inspiratory Trigger is not enabled and system
be could not go to next Inspiratory Phase by ‘En_Sense’ Function.

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.

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3.3.12 Ventilation Modes
The following table show the abbreviations and descriptions of the ventilation mode
supported by the MV2000 ventilator.

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

MASK (Leak Compensation)


This unit has a leak-compensation function. This function is to maintain the basic base
pressure by compensating for the amount of leakage that can occur on the connection
with breathing circuit and the patient. This function can be turned on and off in the
setup window SYATEM screen.

Assist Control Ventilation (A/C)


This is the default mode for all patient types. In Assist Control ventilation mode, all
breaths initiated and delivered are mandatory breaths. The initiation of a breath is
triggered by one of the following:
• Patient effort activates the inspiratory trigger mechanism,
• The breath interval, as set by the RATE control, times out,
• The operator presses the MANUAL BREATH key.
Initiation of a breath by any means resets the breath interval timing mechanism. It is
possible for the patient to initiate every breath if he/she is breathing faster than the
preset breath rate. If the patient is not actively breathing, the ventilator automatically
delivers breaths at the preset interval (set breath rate).

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Figure 3.12 Assist Control Ventilation Waveform

Synchronized Intermittent Mandatory Ventilation (SIMV)

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.

Figure 3.13 SIMV Waveform

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.

Airway Pressure Release Ventilation (AwPRV / Bi-Level)


The AwPRV / Bi-Level ventilation mode is a type of Time Cycled Pressure ventilation,
which is a ventilation mode in which two baseline pressures are cycled based on the set
time in agreement with the patient's respiratory response. The control of ventilation is

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maintained in such a way that the two basic pressures are cycled based on the set time.
In patients with additional spontaneous breathing, additional pressure support may be
used.

In this ventilation mode, spontaneous breathing is allowed in both of pre-set baseline


pressures. These two baseline pressures are adjust and set to PEEP High and PEEP Low.
- Each basic pressure acts like CPAP ventilation mode. This ventilation mode is
equivalent to CPAP ventilation mode for two different pressures. - The maximum hold
time of each pressure is determined by the time adjustment of TH PEEP and TL PEEP.

PSV Control in AwPRV / Bi-Level ventilation mode


PSV can be used at AwPRV / Bi-Level of MV2000 ventilator. By basically, when PSV is
set, it will supply the set pressure every time spontaneous breathing is detected during
PEEP Low. The PSV function can be used in PPEEP High, and only operate at PPEEP High in
the AwPRV ventilation mode.

Airway Pressure Release Ventilation


(AwPRV / Bi-Level)

Figure 3.14 AwPRV/Bi-Level Mode

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SPONT. Mode [Continuous Positive Airway Pressure (CPAP) Pressure
Support Ventilation (PSV)]

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.

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O2 Stream
It can be used for Nasal CPAP and High Flow Nasal Cannula therapy. By limiting the
maximum pressure, it is possible to apply to patients more safely. The maximum pressure
is limited to the Pressure Limit (P Limit) for patient safety.

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.

The strengths and limitations of AutoVent mode are listed below.

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.

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- As a result of monitoring the blood gas concentration and respiratory gas
concentration of patient's patients, simplified management of% Vmin, PEEP, O 2
concentration changes makes patient management relatively stable.

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.)

In AutoVent mode, set the following parameters.


1) PEEP(cmH2O)
2) Trigger Flow/Trigger Pressure
3) Trigger Setting(lpm/ cmH2O)
4) Oxygen Concentration (%)
5) Pressure Limit(cmH2O)
6) Inspiratory Trigger Sensitivity (%)
7) Expiratory Trigger Sensitivity (%)
8) MinVol (%)

C. How to run AutoVent

- First start breathing action


IBW, Vol [%] and calculates the reference values required for operation.
 Maximum inspiratory time and pressure rise time
90 kg or more, inspiration time = 1.5 sec, pressure rise time = 0.4 sec
10 to 90 kg, inspiration time = 1.0 sec, pressure rise time = 0.3 sec
10 kg or less, inspiration time = 0.6 sec, pressure rise time = 0.2 sec
 The standard minute volume is calculated through the PBW and the reference

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table.
Example) Calculate Vmin [l / min]; Vmin = 0.3 x 5 kg = 1.5 L / min

 The target volume per minute is obtained using% Vol [%].


V_target / min (target volume per minute) = standard minute volume x% Vol [%]

 Standard tidal volume is expressed as IBW [kg] x standard tidal volume


standard / kg [ml / kg]
Ex) Vt = 50kg x 8ml / kg = 400ml
 Respiratory rate per minute = V_target / min / Vt

- From the second breath


 Determine Raw, C_lung, and Otis' Rule to determine the number of breaths
(R.Rate) from the patient. At this time, the calculated respiratory rate is limited
to a maximum of 40 bpm and a minimum of 12 bpm.
 The target volume per minute (V_target / min) is divided by R.Rate, and Vt is
obtained.
 The action to match the target Vt is the same as PRVC.
 Even if the upper respiratory rate is determined, the respiratory rate may be
slowed by the active breathing of the patient if the respiratory rate per minute
exceeds the minimum pressure assistance. However, more than the minute
volume is guaranteed.

CPR
(Cardiopulmonary Resuscitation)
CPR mode helps to patient ventilation in the CPR situation of patient.

The following parameters are configured in CPR mode.


1) Tidal Volume (ml)
2) Respiratory Rate (b/min)
3) Pause Time (sec)
4) PEEP (cmH2O)
5) Oxygen Concentration (%)
6) Inspiratory Time (sec)
7) Pressure Limit (cmH2O)
8) Trigger Flow/Trigger Pressure
9) Trigger Setting (lpm/ cmH2O)
10) Beep Guide (BPM)
11) Beep Interval (min)

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BLS (Basic Life Support) Components
Recommendations
Component Adult Pediatric Infants
Compression Rate At least 100/min ( Beep Guide )
Compression Depth At least 2 inches At least 1/3 AP
Chest Wall Recoil Allow Complete Recoil Between Compressions.
HCPs Rotate Compressors Every 2 minutes ( Beep Interval
– Double Beep )
Respiration Rate 8~10 breaths/min
Tidal Volume 6~7 ml/kg

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.

It is difficult to precisely verify the principle of breathing in high frequency ventilation


mode due to the effect of very complicated anatomical lung structure.

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).

This mode is high frequency ventilation mode with single frequency.

Frequency range: 2~ 20Hz.


The setting for adult 4~8Hz (240~480bpm) and Infant 10~15Hz (600~900 bpm) are
recommendable. Select appropriate setting according to patient condition and clinician’s
decision.

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.

MV2000 Ventilator System 85 M01-18-L190 Eng. Ver. 4.42


The Power (amplitude of stroke) does not have the unit of measurement, and the Power
is determined by minimum and maximum power. If Power is increased, the pressure
amplitude and flow rate will increase.
But, about the amplitude of the pressure increased, if Paw is low, the amplitude will be
limited by Paw.

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.

The following parameters are configured in SHFV mode.


1) Power (%)
2) MAP (cmH2O)
3) Frequency Range (Hz)
4) Oxygen Concentration (%)
5) Pressure Pause (cmH2O)

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.

MV2000 Ventilator System 86 M01-18-L190 Eng. Ver. 4.42


EtCO2 measurement is possible during exhalation time in DHFV mode. Although, not easy
to remove carbon dioxide (CO2) due to insufficient ventilation time during operation of
the SHFV mode, CO2 can be removed possible use in the DHFV mode operation.

The following parameters are configured in DHFV 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)

MV2000 Ventilator System 87 M01-18-L190 Eng. Ver. 4.42


3.3.13 Primary Breath Controls

 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.

To adjust the parameters:


Press your finger directly on the setting variable you want to adjust.
At this time, the image frame of the control variable is changed greatly and the
adjustment window of graphic bar type is displayed on the right side of the screen.

MV2000 Ventilator System 88 M01-18-L190 Eng. Ver. 4.42


To change the value of the selected variable if the corresponding column changes as
shown in the figure above, you can turn the encoder of the adjacent figure to increase
or decrease the value. The clockwise direction is upward and the counterclockwise
direction is downward. To bigger or lower set the value change, it can be easily changed
value by touch drag the graphic bar window.

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.

3.3.14 Descriptions of Primary Breath Controls

Breath Rate (Rate)


Can be adjusted the breath interval by adjusting the breath rate. This function can be
affected by the ventilation mode selected and the breath cycle allowed accordingly.
Range: 1 to 150 bpm
Defaults: 12 bpm (Adult)
20 bpm (Pediatric)
30 bpm (Neonate)

Tidal Volume (Volume)


A volume breath delivers a predetermined volume of respiratory gas to the patient.
A tidal volume is supplied according to the set inspiratory flow rate and waveform
settings.
Range: 0.05 to 2.50 L (Adult)
50 to 600 ml (Ped-iatric)
2.0 to 150 ml (Neonate)
Defaults: 500 ml (Adult)
100 ml (Pediatric)
5 ml (Neonate)
Sigh: 1.5 x Volume (Adult/Pediatric only)

Inspiratory Pressure (Insp Pres)


It’s the inspiratory pressure delivered during mandatory breath in the type of pressure
ventilation. If, set the PEEP, the pressure delivered to the patient is the PEEP with plus
the inspiratory pressure.
During a mandatory pressure breath, the ventilator controls the inspiratory pressure in
the breathing circuit and airway. For Pressure & TCPL breaths, the pressure achieved is
a combination of the preset Insp. Pressure level plus PEEP.

MV2000 Ventilator System 89 M01-18-L190 Eng. Ver. 4.42


Range: 0 to 99 cmH2O (Adult/Pediatric)
0 to 99 cmH2O (Neonate)
Default: 15 cmH2O

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)

Inspiratory Time (I-Time)


The I-Time controls set the inspiratory time cycle variable for all mandatory pressure,
CPR, TCPL or PRVC breaths.
Range: 0.1 to 9.9 seconds
Default: 1.0 second (Adult)
0.75 seconds (Pediatric)
0.35 second (Neonate)

Inspiratory Pause (Insp Pause)


Inspiratory Pause is the amount of time that breath is maintained without being
switched to expiratory phase after the tidal volume set in Volume Breath is delivered.
Sets an Inspiratory Pause, which will in applies for volume breath delivered.
A preset inspiratory pause time will be delivered with each volume breath.
Range: 0.0 to 2.0 seconds
Default: 0.0 second

PSV (Pressure Support)


PSV can be used in all ventilation modes where spontaneous breath is permitted and
supports the set pressure in system operation.
The PSV control set the pressure in the breathing circuit and airway during the pressure
support breath.
Range: 0 to 99 cmH2O
Default: 0 cmH2O

Positive End Expiratory Pressure (PEEP)


PEEP is the pressure that is maintained in the patient circuit at the end of exhalation.
Range: 0 to 60 cmH2O
Defaults: 6 cmH2O (Adult/Pediatric)
3 cmH2O (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

Inspiratory Flow Trigger (Flow Trig)

MV2000 Ventilator System 90 M01-18-L190 Eng. Ver. 4.42


The patient inspiratory effort detection method is use the changed of the flow rate
which the flow rate of the set Bias Flow + Flow Trigger setting value is detected from
the inspiratory port and the difference in the flow value detected by the flow sensor in
the expiratory port. When the flow rate changed by the patient's inspiration effort is
swallowed above the Flow Trigger setting value, the device recognizes the inspiratory
effort of the patient when the flow rate difference detected by the flow sensor of the
expiratory port exceeds the set value, and the operation is started accordingly
The inspiratory trigger mechanism* is activated when the Net Flow becomes greater
than the Inspiratory Flow Trigger setting. Net Flow is defined as [Delivered Flow −
Exhaled Flow] (or Wye Inspiratory Flow when using a wye flow sensor). When the
Inspiratory Flow Trigger is enabled, a low level of Bias Flow is delivered to the patient
circuit during the exhalation phase of the breath.
Range: 0.1 to 20.0 L/min
Defaults: 3.0 L/min (Adult)
2.0 L/min (Pediatric)
1.0 L/min (Neonate)

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%

Pressure High (PEEP High)


Pressure High (PEEP High) is the upper CPAP of the two CPAP pressures, which can be
operated only in the AwPRV / Bi-Level ventilation mode and it's maintained for Time
High (upper sustained pressure hold time).
Range: 3 to 50 cmH2O
Default: 15 cmH2O

Pressure Low (PEEP Low)


Pressure Low (PEEP Low) is the lower CPAP of the two CPAP pressures, which can be
operated only in the AwPRV / Bi-Level ventilation mode and it's maintained for Time
Low (lower sustained pressure hold time).
Range: 0 to 50 cmH2O
Default: 5 cmH2O

Time High (TH PEEP)


Time High (TH PEEP) can be operated only in AwPRV / Bi-Level ventilation mode and

MV2000 Ventilator System 91 M01-18-L190 Eng. Ver. 4.42


determined the holding time of the Pressure High.
.
Range: 0.2 to 50 seconds
Default: 2 seconds

Time Low (TL PEEP)


Time Low (TL PEEP) can be operated only in Bi-Level ventilation mode and determines
the holding time of Pressure Low.
Range: 0.1 to 49.9 seconds
Default: 2 second

3.3.15 Sub-Breath Controls

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

MV2000 Ventilator System 92 M01-18-L190 Eng. Ver. 4.42


secondary setting variable. The PS default setting is 0 cmH2O.

Sub Settings Characteristics and Ranges


Inspiratory Rise Time
Controlled the speed at which pressure is reached or delivered to inspiratory pressure
set by breathing.

Range: 0.1 to 0.5sec.


Default: 0.2sec.
The Inspiratory Rise control is not operates in the TCPL breaths.

Ex_Sens [Exh. trigger Sensitivity (Flow Cycle)]


The flow cycle control is a function that terminate the inspiratory phase when the flow
rate decreases to the set percentage compared to peak inspiratory flow rate (Peak
Flow).
Only applies to function of the Pressure Support Ventilation.
Range: OFF, 5 to 80%
Default: 30%

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.

MV2000 Ventilator System 93 M01-18-L190 Eng. Ver. 4.42


The Ex_Sense means Exhalation Trigger sensitivity in pressure mode. The purpose is to
reduce exhalation W.O.B (work of breathing) of patient in pressure support ventilation
(PSV).
It reduces patient’s expiratory effort compared to the pressure detection mode in the past
and the ventilator responds rapidly to the effort of 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.

Waveform [Fend (Flow Pattern)]


The decelerating flow is used in order for possible effective breathing to be taking place
if the same volume is delivered by adjusting the flow pattern.

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.

MV2000 Ventilator System 94 M01-18-L190 Eng. Ver. 4.42


User can be adjusted the flow pattern from 100% to 25% in Volume Ventilation. If set
to 100%, the flow pattern is Square wave form, if set to 25%, the flow pattern is
Decelerating wave form. The default value is 25% (Decelerating Wave).

Square Wave (Sq) (F-end 100%)


When this waveform is selected, the respiratory gas of this flow pattern is delivered the
set maximum inspiratory flow rate and maintained throughout the inspiration phase.

Decelerating Wave (Dec) F-end 99 to 25%)


Selected this waveform, the pattern of flow starts to deliver the respiratory gas at a set
maximum inspiratory flow rate, and delivering flow rate is decreased from 99% to 25%
in this flow pattern, which is slow the inspiratory flow progresses.

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.

The maximum sigh volume is 1,500ml.


Range: Every 0, 30, 60, 90, 120 Breath
Sigh Volume: 1.5 times set tidal volume
Sigh Breath Interval (sec): Normal Breathing period x 2 (Assist mode) or Normal
Breathing period (SIMV mode)
Default: Off

CAUTION
This function is only available in VCV ventilation in adult and pediatric patients.

Flow Limit (Flimit)


Flow Limit is limited the maximum flow rate to the patient in PSV ventilation mode.
Adjustable from 10 to 30 LPM, or, there is no flow limited if set to Off.
Range: OFF, 10 to 60 l/min
Default: OFF.

MV2000 Ventilator System 95 M01-18-L190 Eng. Ver. 4.42


The setting parameters provided by the MV2000 ventilator are shown in the table below.
Item Unit Description
VTi mL Inspired tidal volume
FLOW LPM Flow rate
FLIMT LPM Flow limit
Pinsp cmH2O Inspiratory pressure
PS cmH2O Pressure Support
PEEP cmH2O Positive end expiratory pressure
Plimit cmH2O Pressure limit
PEEP H cmH2O PEEP high
PEEP L cmH2O PEEP low
PS Upper cmH2O PS of PEEP H
PS Low cmH2O PS of PEEP L
Map cmH2O Mean airway pressure
Ppause cmH2O Pause pressure (or, plateau pressure)
RR BPM Respiration rate
Tinsp second Inspiratory time
Trise second Rise time
Trise PSv second Rise time in PS
Tpause second Pause time
Apnea second Apnea
Apnea mode Apnea mode
Sigh RPB Sigh
TH PEEP second High PEEP time
TL PEEP second Low PEEP time
O2 % Oxygen percentage
minVol % Minimum minute volume percentage
EnSENS % Enable sensing (ratio of expiratory tidal volume to tidal
volume allowed for triggering)
ExSENS % Exhalation sensitivity (Flow cycle)
Trigger Triggering sensitivity
P Trig. cmH2O Pressure trigger
F Trig. LPM Flow trigger
Adaptive Flow Select use adaptive flow
BGuide BPM Beep sound guide (CPR chest compression guide ‘beep’
sound)
BInterval minute Beep sound sustained interval
High frequency Ventilation
H.Freq Hz Frequency of HFV
Power % Power of HFV
IMV Etime second IMV expiration time in HFV

MV2000 Ventilator System 96 M01-18-L190 Eng. Ver. 4.42


Chapter 4 Monitors,Displays & Maneuvers

4.1. Measurements display

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.

Item Unit Description


Spirometry
Ppeak cmH2O Peak Inspiratory Pressure
Ppause cmH2O Pause Pressure
PAW cmH2O Airway Pressure
Pmean cmH2O Mean Airway Pressure
VTi mL Inspired tidal volume
VTe mL Expired tidal volume
VMe LPM Expired Minute Volume
Fpeak LPM Peak Flow Rate
PEEP H cmH2O High PEEP
PEEP L cmH2O Low PEEP
PEEP cmH2O Positive End Expiratory Pressure
Monitoring - Mech/Spont
RR BPM Respiration Rate
RR SPONT BPM Spontaneous Respiration Rate
VMe S. LPM Spontaneous minute volume
P 0.1 cmH2O Respiratory Drive (P0.1), is the negative
pressure that occurs 100 ms after an
inspiratory effort has been detected
RSBi b/min/mL Rapid Shallow Breathing Index
WOBv J/L Work of Breathing Ventilator
WOBp J/L Work of Breathing Patient
Monitoring – Timing
TI second Inspiratory time
TE second Expiratory time
I:E ratio Inspiratory/expiratory ratio
Monitoring – Pulmonary
CL mL/ cmH2O Lung Compliance
RA cmH2O /s Airway Resistance
AutoPEEP cmH2O AutoPEEP, is the airway pressure at the end of
an expiratory hold maneuver.
Exp.Flow LPM Expiration Flow
E cmH2O /L Elastance
Tc second Time Constant
Monitoring – EtCO2

MV2000 Ventilator System 97 M01-18-L190 Eng. Ver. 4.42


EtCO2 mmHg/ % End Tidal Carbon dioxide
iCO2 mmHg/ % Inspired CO2
RR RPM Respiration Rate
Monitoring – HFV
VTe Stroke mL Stroke Volume
H.Freq Hz Frequency
Amplitude cmH2O Amplitude
Monitoring – FiO2
O2 % Percentage of oxygen
Monitoring – SpO2
PR BPM Pulse Rate
SpO2 % Saturation of Hemoglobin with Oxygen As
Measured by Pulse Oximetry

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.

MV2000 Ventilator System 98 M01-18-L190 Eng. Ver. 4.42


To see the full measure of the measured value display, press anywhere on the monitoring
window will appear as shown above. If you want to change the display variable of the
measured value display window, press the corresponding display box first and then select
the measurement variable in the opened whole monitoring window and then close the
window to display the newly selected display variable in the selected display area.

4.1.2. List of measures and calculated values

Item Unit Description


P PEAK cmH2O Maximum inspiratory pressure
P PAUSE cmH2O Pressure during end-inspiratory pause
P MEAN cmH2O Mean airway pressure
PEEP cmH2O Positive end expiratory pressure
Auto PEEP cmH2O Difference between measured PEEP and configured PEEP
P 0.1 cmH2O Indicator for respiratory drive
VI TIDAL mL Inspiratory tidal volume (per breath)
VE TIDAL mL Expiratory tidal volume (per breath)
VE MIN LPM Expiratory minute volume (per minute)
PEEP H cmH2O High PEEP
PEEP L cmH2O Low PEEP
F PEAK LPM Maximum inspiratory flow
RESP.R BPM Respiration
RR SPONT BPM Respiration rate in spontaneous breath

MV2000 Ventilator System 99 M01-18-L190 Eng. Ver. 4.42


VEMIN LPM Expiratory volume per min in spontaneous breath
SPONT
TI sec Inspiration time
TE sec Expiration time
I:E Inspiration to expiration ratio
Exp.Flow LPM Expiration flow
RSBi b/min/mL Rapid shallow breathing index
O2 % Oxygen concentration in volume %
CL mL/ cmH2O Compliance
RA cmH2O /s Resistance
PR BPM Pulse Rate
SpO2 % Oxygen saturation in blood
EtCO2 mmHg/ % End tidal carbon dioxide
iCO2 mmHg/ % Inspiratory carbon dioxide
RESP RPM Respiration through EtCO2
VI CO2 Ml Inspiratory CO2 Tidal Volume
VE CO2 Ml Expiratory CO2 Tidal Volume
VE MIN CO2 Ml Expiratory Minute CO2 Volume
VE STROKE Ml Expiratory CO2 Tidal Volume
H.Freq Hz Frequency of High Frequency Ventilator
Amplitude cmH2O Amplitude of High Frequency Ventilator
WOBv J/L Work of Breathing Ventilator
WOBp J/L Work of Breathing Patient

4.1.3. Monitoring Range


Description Monitoring Range
Ppeak, Ppause, PAW, Pmean, PEEP H, PEEP L, PEEP, 0~140 cmH2O
AutoPeep, P0.1, Amplitude
VTi, VTe, Ve.Stroke, Vi CO2, Ve CO2, VEm CO2 0 ~ 3000 mL
VMe, Fpeak, VEmin S. Exp.Flow 0 ~ 330 LPM
RR, RR spont, EtCO2 RR, SpO2 2 ~ 150 BPM
H.Freq 0 ~ 30 Hz
RSBi 0 ~ 9999 b/min/L
WOBv, WOBp 0 ~ 585.9 J/L
TI, TE, Tc 0 ~ 60 second
CL 2 ~ 100 mL/cmH2O
RA 5 ~ 100 cmH2O/L/sec
E 100 ~ 5000 cmH2O/L
O2, SpO2 0 ~ 100 %
EtCO2, iCO2 0 ~ 25 %

4.1.4. Graphic Displays


When SpO2 and EtCO2 options are connected, color-wise waveforms are displayed on the
screen as follows. Up to four waveforms can be displayed on the screen.

- Pressure vs. time


- Flow vs. Time

MV2000 Ventilator System 100 M01-18-L190 Eng. Ver. 4.42


- Volume vs. Time
- SpO2 vs. Time
- EtCO2 vs. Time

4.1.5. Characteristics
Waveforms are displayed on the screen as follows.
Measured parameter values are displayed according to time axis.

- Parameter and scale are displayed on Y axis.


- Pressure vs. time graph is displayed in dark pink.
- Flow vs. time graph is displayed in dark sky-blue.
- Volume vs. time graph is displayed in white.
- SpO2 vs. time graph is displayed in yellow.
- EtCO2 vs. time graph is displayed in white.

4.1.6. Wave setting and changing


Layout of waveform can be configured and changed through [Views] menu on the bottom
of user interface.

To change displayed graphs, touch waveform. The following window appears for each graph,
allowing user to select wanted graphs.

MV2000 Ventilator System 101 M01-18-L190 Eng. Ver. 4.42


Basic Screen 3 Waves 2 Loops & 3 Waves

6 Big Numeric data 4 Big Numeric data & 2 Waves

4 Big Numeric data, 1 Loop & 2 Waves Trend

MV2000 Ventilator System 102 M01-18-L190 Eng. Ver. 4.42


- Wave form: Pressure, Flow, Volume
If SpO2 and EtCO2 modules are connected through option, two additional graphs can be
viewed.
- Loop : P-V, V-F, P-F
- Trend : VE min, Pmean, Ppeak, PEEP, VTe, RESP, CL, RA, SpO2, PR, EtCO2, iCO2

4.2. Loop graph


The Loops function is a graphical displayed of the relations between Pressure-Flow, Flow-
Volume, and Pressure-Volume.

Loops Refer to Section 4.2.2 for graph settings.

MV2000 Ventilator System 103 M01-18-L190 Eng. Ver. 4.42


4.3. Trend
The trend values are saved every 6 seconds.. The trend graph can be displayed as 30
minutes, 3 hours, 12 hours, 24 hours and72 hours. Each graph display update interval is
as follows.

Graph Display Time Update Interval Note


30 minutes 6 seconds Saved value every 6 seconds
3 hours 36 seconds Average value for 36 seconds
12 hours 144 seconds Average value for 144 seconds
24 hours 288 seconds Average value for 288 seconds
72 hours 864 seconds Average value for 864 seconds

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

MV2000 Ventilator System 104 M01-18-L190 Eng. Ver. 4.42


Waveform Choices
Heading Display Waveform Shown
Paw (cm H2O) Airway Pressure
Pinsp (cmH20) Airway Pressure at Machine Outlet
Pes (cmH2O) Esophageal Pressure
Ptr (cmH2O) Tracheal Pressure
Ptp (cmH2O) Transpulmonary Pressure
Flow(L/min) Flow
Vt (ml) Airway Tidal Volume
SpO2 Pleth
EtCO2 Capnogram

4.5. Maneuvers
4.5.1. P-V Tool

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6

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.

MV2000 Ventilator System 106 M01-18-L190 Eng. Ver. 4.42


7) Range The graph range of pressure and volume is changed. The maximum
of volume (Y-axis) is 2,500ml and the maximum of pressure (X-axis)
is 60 cmH2O.

8) Loop Plot Pressure and Volume of stored plots.


9) Reference Let’s you scroll through the last 5 stored P/V Tool curves.
Up to five measured graphs can be saved with the P-V tool
maneuver. The oldest value is automatically cleared when the sixth
measured value is stored. When 'Reference' is ON, the graphic of
the selected time is overlaid on the Loop graph.
10) Set flex Upper Pflex and Lower Pflex determination;
point When the Maneuver is finished, the existing ventilation mode
resumes. At the end of the maneuver, the PAW / Vol loop is
automatically displayed as a still image, and the cursor '+' column
is displayed on the graph.
At this time, the user can set the displayed Pflex value by turning
the Encoder, move the display point to the appropriate position of
the PV loop graph, and confirm by pressing the SET button. Once
the upper and lower inflection points are established, the delta Pflex
volume is calculated and displayed. The instrument can store the
values of the four P-V tool maneuvers.

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.

MV2000 Ventilator System 107 M01-18-L190 Eng. Ver. 4.42


4.6. Esophageal/Tracheal Pressure (Option)

A catheter can be connected to the Proximal Pressure Sensor terminal to measure


esophageal pressure or tracheal pressure.

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.

4.6.1. 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.

MV2000 Ventilator System 108 M01-18-L190 Eng. Ver. 4.42


- Ptp plat (After “Ins. Hold” maneuver)
Transpulmonary pressure during an inspiratory hold, which is the difference between the
airway plateau pressure (PPLAT AW) and the corresponding esophageal pressure. Requires
an inspiratory hold and esophageal balloon.

- 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).

- Ptp PEEP (After “Exp. Hold” maneuver)


The difference between the corresponding airway and esophageal pressures at the end of
the expiratory hold during an AutoPEEP maneuver. Requires an inspiratory hold and
esophageal catheter.

- ΔAutoPEEP (After “Exp. Hold” maneuver)


The difference between airway pressure at the end of an expiratory hold maneuver and
the airway pressure at the start of the next scheduled breath after the expiratory hold
maneuver. Requires a passive patient.

- AutoPEEP es (Display after patient trigger)


The difference between esophageal pressure measured at the end of exhalation (PEEPES)
minus the esophageal pressure measured at the start of a patient-initiated breath (PES
start) and the sensitivity of the ventilator’s demand system.
The sensitivity of the ventilator’s demand system is the difference between the baseline
airway pressure (PEEPAW) and the airway pressure when the patient initiates a breath
(PAW start). Requires an esophageal balloon.

- Ptp (Paw – Pes Value)

4.6.2. 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

MV2000 Ventilator System 109 M01-18-L190 Eng. Ver. 4.42


intubation tube. The airway pressure displayed on the ventilator is higher than the set
value.

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.

- Breathing problem, ex: Apnea


- Power problem, ex: Battery mode
- Gas problem, ex: Reduced gas pressure

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.

MV2000 Ventilator System 110 M01-18-L190 Eng. Ver. 4.42


5.1.1. Alarm display
If an alarm occurs, it is displayed on the screen with a message as follows.

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.

5.2. Alarm Removal


5.2.1. View Current Alarms

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.

5.2.2. Alarm Reset


The Alarm Reset button (fixed key button on right side of LCD) turns off all latched alarm
indicators (alarms that are no longer violated) and removes the corresponding alarm
message from the Alarms & Messages Bar.
In addition, when the current alarm condition are ends, the alarm action is automatically
released.

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.

MV2000 Ventilator System 111 M01-18-L190 Eng. Ver. 4.42



1) Alarm Silence (2 min)


2) Alarm Reset

5.2.3. Mute the Alarm Sound


When press the Alarm Silence button (fixed key button on right side of LCD),
- Mutes of audible alarms for 2 minutes in current audible alarms.
- While the alarm silence is active, the bell shape and remaining time of silence are
displayed in the message window.
- Each time user press the Alarm Silence button, it will silence for 2 minutes.
- To cancel an active alarm silence, press Alarm Silence again.

5.2.4. Alarm Sound Volume Control

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.

MV2000 Ventilator System 112 M01-18-L190 Eng. Ver. 4.42


5.3. Alarm Setting
This Section explains alarm screen display, alarm setting

5.3.1. Alarm Screen Display

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.

5.3.2. Alarm Setting


Alarm icon of the screen when configuring alarm values. A new menu called Alarm Set
appears. This menu can be used to configure alarms.

1) MV2000 Alarm range

Item Range Default Unit Step


VE TIDAL HIGH 5~2500 ,OFF OFF mL 5
VE TIDAL LOW 0~2500 50 mL 5
VE MIN HIGH 0.1~50 12 LPM 0.1
VE MIN LOW 0.0~49.9 1.2 LPM 0.1
R RESP HIGH 3~180 30 BPM 1
R RESP LOW 2~179 5 BPM 1
P PEAK HIGH 1~120 80 cmH2O 1
P PEAK LOW 0~119 0 cmH2O 1
O2 HIGH 19~100, OFF OFF % 1
O2 LOW 18~100 20 % 1
AIR LEAK 50~500, OFF 300 mL 10
Apnea 2~60 20 sec 1
SpO2 HIGH (optional) 52~99, OFF OFF % 1
SpO2 LOW (optional) 51~99 81 % 1
PR HIGH (optional) 30~250 150 BPM 5
PR LOW (optional) 25~245 50 BPM 5
EtCO2 HIGH (optional) 0~15.0 6.0 % 0.1
EtCO2 LOW (optional) OFF, 0~14.9 OFF % 0.1
iCO2 HIGH (optional) 0~15.0 3.0 % 0.1
iCO2 LOW (optional) OFF, 0~14.9 OFF % 0.1
RESP HIGH (optional) 2~180 30 BPM 1
RESP LOW (optional) 1~179 5 BPM 1

MV2000 Ventilator System 113 M01-18-L190 Eng. Ver. 4.42


5.4. Alarm Message

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.

5.4.2. Alarm and Error Message

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.

MV2000 Ventilator System 114 M01-18-L190 Eng. Ver. 4.42


Measured value of Minute Volume is lower than alarm
limit.
After more
There is little effort by the patient breathes.
than 1
VMIN LOW There is leakage around cuff of intubation tube.
4 minute
(High) There is leakage in the patient’s breathing circuit line.
ventilator
Alarm setting is inappropriate.
operation.
This alarm is activated after ventilator operation for
1 minute or longer.
Measured value of airway pressure is higher than
alarm limit.
Patient breathing circuit line is twisted or obstructed.
Mucus or secretions obstruct the intubation tube or
PRESSURE
airway.
5 HIGH Immediate
Patient is coughing or patient breathing is fighting (in
(High)
case of asynchrony) with the ventilator.
Inspiratory flow is extremely high.
Alarm setting is inappropriate.
Expiratory filter is obstructed.
Measured value of airway pressure is lower than
alarm limit
PRESSURE There is leakage around cuff of intubation tube
6 LOW Immediate There is leakage in the patient’s breathing circuit line
(High) Alarm setting is inappropriate
‘PRESSURE LOW’ is not applied for Spontaneous
breathing.
Measured value of PEEP is higher than the alarm
limit.
Alarm setting is inappropriate.
PEEP H
7 Immediate Patient breathing circuit line is twisted or blocked.
(High)
Mucus or secretion obstructed endotracheal tube or
airway.
Expiratory filter is obstructed.
Measured value of PEEP is lower than the alarm limit.
PEEP L Alarm setting is inappropriate.
8 Immediate
(High) There is leakage around cuff of intubation tube.
There is leakage in the patient’s breathing circuit line.
Measured value of respiratory rate is higher than the
After an
R-R HIGH alarm limit.
9 average of
(High) Auto triggering occurs.
four breaths
Respiratory rate is too high.
Measure value of respiratory rate is lower than the
After an
R-R LOW alarm limit.
10 average of
(High) Trigger sensitivity setting is inappropriate.
four breaths
Respiratory rate is too high.
Measured value of Tidal Volume is higher than alarm
limit.
VTIDAL Patient breaths has been increased by patient's
11 HIGH Immediate effort.
(High) Self-triggering (auto cycling) occurred in the
ventilator.
Alarm setting is inappropriate.

MV2000 Ventilator System 115 M01-18-L190 Eng. Ver. 4.42


Measured value of Tidal Volume is lower than alarm
limit.
VTIDAL After an There is leakage around cuff of intubation tube.
12 LOW average of There is leakage in the patient’s breathing circuit line.
(High) two breaths Alarm setting is inappropriate.
‘VTIDAL LOW’ is not applied for Spontaneous
breathing.
After more
than 1
minute Measured value of % Oxygen is higher than alarm
O2 HIGH
13 ventilator limit.
(High)
operation or Alarm setting is inappropriate.
O2 alarm
setting
After more
than 1
minute Measured value of % Oxygen is lower than alarm
O2 LOW
14 ventilator limit.
(High)
operation or Alarm setting is inappropriate.
O2 alarm
setting
Inspiratory flow is above 8Lpm and expiratory
CIRCUIT pressure below 3cmH2O is sustained over 10
15 OPEN Immediate seconds, or over 8L is supplied.
(High) Patient breathing circuits line or Exh. valve assembly
are disconnected
Air gas is not connected or not supplied.
Air FAIL
16 Immediate When ventilator operating, and if air supply gas is
(High)
sustained less than 25 psi for more than 3 seconds.

Oxygen gas is not connected or not supplied


O2 FAIL
17 Immediate When ventilator operating, and if oxygen supply gas
(High)
is sustained less than 25 psi for more than 3 seconds

After three Linked to leakage volume (mL) configured by user


consecutive Used when the difference between Insp volume and
respirations Exp volume is larger than leakage volume configured
LEAK
18 After three by user.
( Mid )
consecutive Circuit leakage alarm occurs if difference between
breaths of Insp and Exp volumes occurs during three
leak. consecutive respirations.
Spont, O2 Stream and HFV mode are excluded
VENT INOP
19 Immediate When there is no breathing for period time of three
(High)
breaths from the first 30 seconds onwards.

LOW
When the internal battery use time is remaining 5
20 BATTERY Immediate
minutes
( Mid )

Measured value O2 % is lower than 18% or detected


O2 SENSOR
below 18%.
21 ERR Immediate
O2 cell failed (However, screen only displays 21% or
(High)
above).

MV2000 Ventilator System 116 M01-18-L190 Eng. Ver. 4.42


Clean Exp.
22 Sensor Immediate Check expiratory flow sensor
( Mid )

Chk. P.
Sensor port of Exhalation valve assembly is not
23 Port Immediate
connected or obstructed.
(High)

BATTERY Average AC power is not connected or faulty the electrical


24 MODE value in 10 power.
( Low ) second Connect AC power.

COM There is no information of communication


After 10
25 ERROR There are bad cable connections or aged /
seconds
(High) deterioration problems.

There is no response for the transmitted command


COM
After 4 data.
26 ERROR2
seconds There are bad cable connections or aged /
(High)
deterioration problems.

SpO₂ Measured value of SpO2 is higher than setting alarm


27 HIGH Immediate limit
(High) Blood oxygen saturation is high

Measured value of SpO2 is lower than setting alarm


SpO₂ LOW limit
28 Immediate
(High) Blood oxygen saturation is low
If sensor use with attached in one place for too long.

Measured value of RR is higher than setting alarm


PR HIGH
29 Immediate limit
(High)
When pulse rate is high

Measured value of RR is lower than setting alarm


PR LOW
30 Immediate limit
(High)
When pulse rate is low

Measured value of CO2 is higher than setting alarm


CO₂ HIGH limit
31 Immediate
(High) When partial pressure of end-tidal carbon dioxide is
high
Measured value of CO2 is lower than setting alarm
limit
CO₂ LOW
32 Immediate When partial pressure of end-tidal carbon dioxide is
(High)
low
Patient's breathing circuit connection is bad
Measured value of CO2 INS is higher than setting
CO₂ INS alarm limit.
33 HIGH Immediate When partial pressure of inspired carbon dioxide is
(High) high
Patient's breathing circuit connection is poor
Measured value of CO2 INS is lower than setting
CO₂ INS
alarm limit
34 LOW Immediate
When partial pressure of inspired carbon dioxide is
(High)
low

MV2000 Ventilator System 117 M01-18-L190 Eng. Ver. 4.42


Measured value of CO2 RESP is higher than setting
CO₂ RESP
alarm limit.
35 HIGH Immediate
When the measured number of respiration rate in the
(High)
CO2 module is high.
Measured value of CO2 RESP is lower than setting
CO₂ RESP
alarm limit.
36 LOW Immediate
When the measured number of respiration rate in the
(High)
CO2 module is low.

5.4.3. Audible Alarm Prioritization


Priority Level Description Tone
High-priority audible alarm CCC-CC CCC-
High: Immediate attention
(Sequence of five tones that repeats twice, CC
required to ensure patient safety
pauses, then repeats again).
Medium: Prompt attention Medium-priority audible alarm CCC
necessary (Repeat sequence of three tones).
Low: Changes between the Low-priority audible alarm C
patient-ventilator has occurred. (One tone).

5.4.4. Alarm Test


Testing the alarms requires oxygen and stable AC power. Test the alarms at least every
six months, using the procedures described.

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

Ventilator setup for alarm tests


1. Disconnect the patient breathing circuit from the ventilator and turn the ventilator off
for at least five minutes. (If user had been used the ventilator)
2. Connect the patient breathing circuit and all accessories to the ventilator
3. Connect the adult test lung to the patient side Y-connector of breathing circuit

MV2000 Ventilator System 118 M01-18-L190 Eng. Ver. 4.42


4. Turn the ventilator power on.
5. Select New Patient in the screen and select the ‘Male’ patient type
6. Set the following parameter in the New Patient
PBW: 70 kg (Press the ‘Patient Height’, and adjust the height, then will changes the
body weight)
Mask Leak Sync: Off (Press the ‘System’ icon and ‘Leak Sync’, and make sure to off)
Mode: VSIMV (Press the MODE and select the VCV mode, and turn on the VSIMV)
Trigger type: Ptrigger (Pressure trigger)
7. Set the following parameters
Vtidal: 500 mL
Ti: 1.7 sec
Rate: 12 bpm
O2 %: 21 %
PEEP: 3 cmH2O
8. Set the following parameters for apnea backup settings
Apnea Time: 10sec
O2 %: 21 %
PEEP: 3 cmH2O
Vtidal: 500 mL
9. Set the following parameters in alarm settings
VTeMax: OFF
VTeMin: 300
VE MIN Max: 7.0 Lpm
VE MIN Min: 2.0 Lpm
RATE Max: 30 bpm
RATE Min: 5 bpm
Paw Max: 80 cmH2O
10. Press ‘Accept’ button for following test procedure

CIRCUIT Open alarm test


 During the inspiratory phase of a breath, disconnect the inspiratory filter from the
patient port. The CIRCUIT OPEN alarm is activates at the ventilator if the inspiratory
filter is disconnected. After confirmed the alarms, connect again the inspiratory filter
to the ‘To Patient port’ for alarm auto-reset.
 Confirm the alarm is deactivated.

LOW Exhaled Mandatory Tidal Volume alarm test


 Set Tidal Volume to 200 mL. After accepted 200 mL of set Tidal Volume, the Low
Tidal Volume alarm will be activated at the ventilator on the third respiration.
 Confirm the alarm activated, and leave the changed parameters for the next test.

LOW Exhaled Total Minute Volume alarm test


 Set low Minute Tidal Volume alarm limit (VE MIN Min) to 3.0 L/min. After accepted
set Low Minute Volume alarm limit (VE MIN Min) 3.0 L/min, the Low Minute Volume
alarm will be activated at the ventilator when 1 minute respiration elapsed.
 After confirmed the alarm, and set to original Tidal Volume 500mL for alarm auto-
reset of both Low Tidal Volume alarm and low Minute Volume alarm.

APNEA alarm test


 Set the followings for the Apnea alarm test
 Select SPONT mode and press Accept
 When apnea setting time is elapsed after press Accept button for SPONT mode, the
screen appears an 'APNEA' alarm.

MV2000 Ventilator System 119 M01-18-L190 Eng. Ver. 4.42


 Squeeze (press) the test lung for few times. When squeeze (press) the test lung
few times for simulate as like as patient-initiated breaths, the APNEA alarm will be
deactivated automatically (auto-reset).
 Stop the squeeze (pressing) of test lung, and wait the apnea time elapsed, the
‘APNEA’ alarm occurs again.

Oxygen (O2) Supply alarm test


 Disconnect the oxygen gas supply source. The ventilator activates O2 Supply Fail
alarm and audible sound immediately (within one breath).
 Connect again the oxygen gas supply source. The O2 Supply Fail alarm and audible
sound are auto-reset and disabled audible sound within two breaths after oxygen
gas supply source is connected.

Obstruct alarm test


 Set the followings for the Obstruct alarm test
 Disconnect the inspiratory filter or inspiratory circuit line from the ‘To patient port’.
 Block the ‘To patient port’.
 When block the ‘To patient port’, the Obstruct alarm and audible sound are
activates immediately.
 Confirmed the alarms activated, reconnect the inspiratory filter or inspiratory circuit
line.

MV2000 Ventilator System 120 M01-18-L190 Eng. Ver. 4.42


Chapter 6 Maintenance and Cleaning

6.1. Summary of Cleaning Process


This Appendix provides summary of cleaning and disinfection processes.

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

MV2000 Ventilator System 121 M01-18-L190 Eng. Ver. 4.42


Cleaning process for when had not been used bacterial filter in breathing circuit.

Disassemble

Wiping / Disposal

Cleaning

Cleaning Disinfectant
Sterilizer

Cleaning

Drying

Reassemble

MV2000 Ventilator System 122 M01-18-L190 Eng. Ver. 4.42


6.2. Preparation / Disassemble
6.2.1. Preparation
- Turn off the power of ventilator using switch button on the back of main body.
- Disconnect the main power and gas hoses from the ventilator.
- Turn off the power of surrounding devices and separate them from the ventilator.

6.2.2. Detaching and disassemble the Exhalation Valve Assembly


- Disconnect all breathing circuit lines from the exhalation valve assembly.
- Slide the locking lever to the left and pull out the exhalation valve assembly.

MV2000 Ventilator System 123 M01-18-L190 Eng. Ver. 4.42


6.3. Wiping / Disposal
6.3.1. Wiping
- Wipe ventilator and all parts using soft cloth with detergent or disinfectant.

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.

MV2000 Ventilator System 124 M01-18-L190 Eng. Ver. 4.42


6.3.3. Cleaning before disinfection

Take the following steps.


- Soak the component parts in water (<35℃/95℉) and clean.
- Make running water to pass through internal and external component parts.

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.

6.4. Cleaning process

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

MV2000 Ventilator System 125 M01-18-L190 Eng. Ver. 4.42


CAUTION
Do not soak the metal-plated component parts of ventilator (ex: electric or electronic
connectors of accessories, flow sensors of exhalation valve assembly) in disinfectants.
Otherwise, it may damage the component parts.

ATTENTION
Follow recommendations and guidelines by the manufacturer. Otherwise, it may damage
the component parts.

6.4.2. Rinsing After Cleaning


- Rinse sufficiently with water to remove all disinfectants from parts. Clean parts in
running water.
- Turn upright, shake horizontally, and tilt.
- Repeat the above step at least 5 ~ 7 times.

ATTENTION
Chemical precipitates may influence the patient, induce leakage, or damage parts.

6.4.3. Drying Method


Expiratory valve assembly must be dried before use.

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

- After cleaning, record it disinfection log according to the hospital’s regulation.


- Make sure that the exhalation valve assembly makes a "click" when mounting it on the
ventilator.
- Once assembled all components and breathing circuit, use a test lung to perform a pre-
use check before using the ventilator.
- If the ventilator does not operate properly, re-check that 'exhalation valve assembly'
assembled well and verify connections of breathing circuit and each components.

6.6. EtCO2 Module/Sensor Cleaning


- After use, clean or disinfect the relevant airway adapter/cannula/etc or dispose of them
according to the hospital policy.

MV2000 Ventilator System 126 M01-18-L190 Eng. Ver. 4.42


6.6.1. Preparation
- Detach the EtCO2 main unit/sensor and connection cable from the ventilator.

6.6.2. EtCO2 Module Body/Sensor

- 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.

MV2000 Ventilator System 127 M01-18-L190 Eng. Ver. 4.42


6.6.3. Airway Adapter
Airway adapter can be disinfected or sterilized.

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.

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If the flow sensor in the exhalation valve assembly is visible soiling or partially clogged,
should be replace or clean the flow sensor and calibrate the flow sensor within at least
24 hours.
After nebulization
If a filter is used in order to protect the flow sensor or the expiratory valve:
1. Replace or remove the filter after medication nebulization.
2. Recalibrate the flow sensor.

6.9. Maintenance

6.9.1. Preventive Maintenance and schedule


The ventilator and peripheral apparatus must be regularly inspected. Preventive
maintenance included in service manual is carried out in case the amount of use of the
ventilator is smaller than ordinary use. Receive at least one inspection per year from the
technical team of our company. In general, consider the ventilator run time of one year
as approximately 5,000 hours.

Always clean inspiratory channel prior to preventive maintenance. Inspiratory cleaning


must be performed by a trained expert

Periodic inspection and maintenance schedule


Period Objects Check point
All Bacteria Filters
Check all filters are properly installed before
- Inspiratory Filter
use.
- Expiratory Filter
Daily Check the connection, leakage, blockage and
Breathing Circuit System
moisture.
Collector Vial, Check if there is moisture(water) and
Gas Supply Water Trap remove it if necessary
Breathing Circuits,
Minimum every half
All Bacteria Filters, Exchange everything, and cleaning to
month or when
Humidification Chamber reusable components/accessories
changed the patient
Exhalation valve assembly
Every year Oxygen Sensor Exchange to new one.
Conduct oxygen sensor calibration by
When necessary Oxygen Sensor
pressing 100% O2 calibration

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

If a service code occurs, replace the part.

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The replacement of parts must only be performed by a skilled personnel or MEKICS
service team trained in the MEKICS.

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.

6.9.2. Battery Replacement

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.

If there is a problem in electrical power source of facility or patient must be transported


while the product is in operation, the internal battery must be use. Therefore the battery
must be charged, and replace the battery if it is considered inadequate.

If voltage is inappropriate, measurement value may result in errors. If battery power is


low, connect to electrical power outlets.

In case of abnormality in battery, contact [Sales / Customer Service] for necessary service.

Refer to the following diagram for battery replacement.

MV2000 Ventilator System 130 M01-18-L190 Eng. Ver. 4.42


WARNING
Be careful about polarity when replacing battery. Connect (+) to red and (-) to black (if
polarity is mistaken, it may damage the product).
If the battery is short-circuited, can cause explosion and cause harm to the human body
due to the high current. Use the battery of rated voltage and current (12V , 7A).

6.9.3. Accessories
Refer to User Manual of Humidifier manufacturer for details on cleaning methods.

6.10. Transportation and Storage in Hospitals

6.10.1. Prior to Transportation

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.

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6.10.2. During Transportation
Check the following matters before transporting the ventilator whether, the ventilator is
connected to a patient, or not.
- Use the handle on the main body.
- Move slowly the bed and ventilator. During transportation, be careful about pulling
or movement of tubes or breathing circuit connected to the patient.
- When moving or changing location of support arm, be careful about pulling or
movement of tubes or breathing circuit connected to the patient.
- When passing through obstacles such as door threshold, be careful not to tilt the
mobile cart.

6.10.3. Transportation Between Hospitals


MV2000 ventilator can be used during transportation of patients between hospitals.
However, requires medical gases such as O2 and Air gas cylinders.

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℉).

- Do not expose the ventilator to a relative humidity above 90%.

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Chapter 7 Option
7.1. Humidifier
Use of heated humidifier in treatment of patients can be beneficial. Refer to user
manual by the corresponding manufacturer for structure and usage of humidifier.

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.

7.2. EtCO2 (Option)

EtCO2 sensor displays the measured expiratory end CO2 concentration as a graphic
waveforms on the screen.

EtCO2 measurement device is an important means of monitoring proper ventilation and


exhalation conditions in the ventilator by continuously measuring the concentration of
EtCO2 to predict the pCO2 (blood CO2 concentration) value. Also, EtCO2 sensor is a
means to determine respiratory diseases such as asthma based on extraction of various
parameters from capnography waveforms, it is also used for diagnosis.

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 is intended to be connected to a patient breathing circuit for monitoring of inspired gas


and expired gases during anesthesia, recovery and respiratory care.
It may be used in the operating room, intensive care unit, patient room and emergency
medicine aid for adult, pediatric and infant patients.

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.

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1 2 4 1
3
Stage Description
Initial stage of expiration in which gas inside anatomical dead space with
1~2
almost no carbon gas is discharged
Stage in which gas from pulmonary alveoli and gas inside anatomical dead
2~3
space are mixed and discharged
3~4 Stage in which gas from pulmonary alveoli is discharged
Partial pressure (concentration) of carbon dioxide towards the end of
4
expiration
4~1 Inspiration

Refer to Chapter 2, Front Panel Connections, for connection instructions.

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.

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- The IRMA sensor probe is not intended to be in patient contact directly.

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.

7.2.1. EtCO2 Calibration


1) Select System in the menu at the bottom of user interface.
2) Select Calib.menu among System menu.
3) Perform EtCO2 calibration in Calib.menu.

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

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alarm signal generation, it will test to connect the SpO 2 probe with SpO2 simulator.
- The functional tester cannot be used to assess the accuracy of a pulse oximeter probe
or a pulse oximeter monitor.

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

Heart rate may be inaccurate in the following situations.


- When sensor is tightened too much
- When sensor receives excessive medical light, bilirubin light or sunlight
- When measurements on limbs under compression by cuff or pressure bandage.

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.

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- While such devices may be useful for verifying that the sensor, cable, and monitoring
system are functional, however, the functional testers are cannot provide the data
necessary to properly evaluate the performance and accuracy of SpO2 measurements.
- The SpO2 Module displays functional saturation (SpO2) with measurement: the amount
of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to
carries oxygen.
- The SpO2 Module has been validated in the functional testing against a Biotek Index 2
simulator from the low perfusion accuracy. This variation equals plus or minus two
standard deviation.
- MEKICS sensors have been validated for pulse rate accuracy in range of 30-250 bpm
in functional testing against a Biotek Index 2 simulator.

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,

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Republic of Korea), which complies with ISO 80601‐2‐61: 2011(E).
The pulse oximeter with a MDNA disposable finger probe was placed on each volunteer to
evaluate the SpO2 accuracy during steady‐state and non‐motion conditions. Each volunteer
was in a semi‐Fowler’s position, and was connected to a breathing circuit for the
administration of a hypoxic gas mixture containing medical air, oxygen, nitrogen, and
carbon dioxide. For frequent blood sampling, a radial arterial cannula was placed in either
the left or the right wrist of each volunteer after administering a local anesthetic. An air
warmer was applied to the hand with finger probes, to prevent hypo‐perfusion induced by
a cold environment. The gas mixture was controlled to induce various levels of hypoxia
and maintain a stable plateau of oxygen saturation between 70% and 100% SaO 2. Arterial
blood was sampled during simultaneous data collections from the device under test. Blood
samples were immediately analyzed by CO‐oximetry to measure functional SaO2, which
were used as a reference for the comparison of SpO 2 accuracy. Because pulse oximeter
equipment measurements are statistically distributed, only approximately two-thirds of
pulse oximeter equipment measurements can be expected to fall within the ± Arms value
measured by a CO-oximeter.

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

-SpO2i: measured SpO2


-SRi: reference SaO2

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.

7.3.1. SpO2 Connection Method


1. Connect SpO2 sensor cable to the socket on which SpO2 label is attached on the
right side of MV2000 ventilator.
2. Insert a finger on the SpO2 sensor.
3. Wait for a moment until SpO2 measurement values are displayed as a graphic
waveforms.

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WARNING
- The connectors on the SpO2 Extension cable are light silver,
- The connector of the EtCO2 Extension cable is black.
- 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.

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Chapter 8 Specifications
8.1. Ventilator System

8.1.1. Overall Features


The MV2000 ventilator has adopted, tested and approved the following international
standards.

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)

8.1.2. Operating Conditions


- Operating Temperature Range
: 10 to 40 ℃ (50~104℉)

- Operating Atmospheric Pressure


: 70 to 106 kPa (10.2 ~15.4 psi)
- Relative humidity
: 10 to 90%

8.1.3. Non-operating Conditions


- Transport and Storage temperature
: -20 to 70 ℃

- Transport and Storage relative humidity

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: 0 to 95 %
- Transport and Storage Atmospheric Pressure
: 70 to 106 kPa (10.2 ~15.4 psi)

8.1.4. Power Supply


- AC input voltage
: 100-230 VAC, 1 A, 50/60 Hz
- AC input FUSE Rating
: 250 V / T3.15 AH
- Power consumption
: MAX 110 VA
- External DC input voltage
: 12 VDC/ 10A Pb battery
- Internal Battery, rechargeable
: 12 VDC/ 7 Ah Pb battery
: Operating time – 3 hours
: Recharge time – 4 hours

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)

A-weighted sound pressure level


A- weighted sound pressure level, ventilator (average)
i. At a distance of one (1) meter does not exceed 53 dBA below 500 mL/min
A- weighted sound power level, ventilator
i. Does not exceed 64 dBA below 500 mL/min

8.2.2. Gas Supply


- Gas Quality
Supplied gases must be appropriate to medical gas standards.
- O2 and air supply Pressure range
241 ~ 620 kPa (35 ~ 90 psi)
- Oxygen sensor life
1,000,000 Vol.% h
- Internal pneumatic safety pressure, maximum

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30 psi +/- 10 %
- Inspiratory Pressure Limit
100 cmH2O +/-10%

8.2.3. Patient System Connectors


- Conical fittings (mm)
: Inspiratory limb connector - DISS 22mm male
: Expiratory limb connector -DISS 22mm male

- Air and Oxygen inlets


: DISS male / female

8.3. Alarm Setting range

Item Range Unit


VE TIDAL HIGH 5~2500, OFF mL
VE TIDAL LOW 0~2500 mL
VE MIN HIGH 0.1~50 LPM
VE MIN LOW 0.0~49.9 LPM
R RESP HIGH 3~180 BPM
R RESP LOW 2~179 BPM
P PEAK HIGH 1~120 cmH2O
P PEAK LOW 0~119 cmH2O
O2 HIGH 19~100 & OFF %
O2 LOW 18~100 %

AIR LEAK 50~500 ,OFF mL

Apnea 2~60 sec

SpO2 HIGH (option) 52~99, OFF %

SpO2 LOW (option) 51~99 %

PR HIGH (option) 30~250 BPM

PR LOW (option) 25~245 BPM

EtCO2 HIGH (option) 0~15.0 %

EtCO2 LOW (option) OFF, 0~14.9 %

INS HIGH (option) 0~15.0 %

INS LOW (option ) OFF, 0~14.9 %

RESP HIGH(option) 2~180 BPM

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RESP LOW (option) 1~179 BPM

Wall O2/Air pressure fail - -

Obstructed Tube - -

Ventilator in-operation - -

Circuit open - -

8.4. Ventilation Modes


8.4.1. Controlled Ventilation
Volume Control (VACV)
- Volume Assist Controlled Ventilation
Mechanical ventilation is controlled based on air volume, adjusting inspiratory and
expiratory times by force.

Pressure Control (PACV)


- Pressure Assist Controlled Ventilation
This mode controls mechanical ventilation of the patient based on pressure.

Pressure Regulated Volume Control (PRVC)


-Pressure Regulated Volume Controlled Ventilation
Despite advantages of pressure mode, instability of not guaranteeing inspiratory volu
me, caused by long-term or acute change in patient’s respiratory status or long-term
change in lung compliance, is removed.

Time Cycled Pressure Limited (TCPL)


This mode ensures the inspiratory volume supplied to the patient by the set pressure
based on the inspiratory flow rate. A peak inspiratory pressures is set by operator, a
nd during inspiration gas flow is delivered to achieve that set pressure. Especially it i
s recommended mode to neonatal patients.

8.4.2. Supported Ventilation


SPONT
- Spontaneous Ventilation
This mode provides pressure support based on spontaneous ventilation.

tBiLevel
- Spontaneous Ventilation
Identical to SPONT mode, but upper PEEP exists.

8.4.3. Combined Ventilation


VSIMV
(Volume based Synchronized Intermittent Mandatory Ventilation)
This mode to controls ventilation based on the volume according to the patient's
spontaneous breathing.

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PSIMV
(Pressure based Synchronized Intermittent Mandatory Ventilation)
This mode to controls ventilation based on the pressure according to the patient's
spontaneous breathing.

8.5. Communication / Interface


Serial Port
RS-232C – isolated
For Upgrade Firmware Pneumatic Board
Baud rate: 115,200bps
Standard I/O Communication Port
LAN
For Central System Monitor

Monitor
15” TFT LCD
Resolution: 1024 X 768 or 800 X 600

8.6. Setting parameter


1) Setting range

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

MV2000 Ventilator System 144 M01-18-L190 Eng. Ver. 4.42


BTPS OFF, BTPS, STPD
Leak Compensation ON, OFF
Adaptive Flow ON,OFF
OFF, Prox. P, Prox.
Aux. Sensor
Flow
Power(Single/Dual High Frequency
1 ~ 100 %
Ventilation)
MAP (Single/Dual High Frequency
5 ~ 60 cmH2O
Ventilation)
Frequency (Single/Dual High Frequency
2 ~ 20 Hz
Ventilation)
IMV Ex duration (Dual High Frequency
0.2 ~ 6.0 sec
Ventilation)
ExRate (Dual High Frequency Ventilation) 1 ~ 120 bpm

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

8.7. Equipment characteristics

Maximum limited pressure (PLIM max)


A fixed pressure limit to the safety valve limits circuit pressure to < 123 hPa (125 cmH 2O)
at the patient wye.
Maximum working pressure (PW max)
PW max is ensured by the high pressure limit (2PPEAK) when PI is < 100 cmH2O (98.07
hPa)
Response time to change in FiO2 setting from 21% O2 to 90% O2 (measured at
the patient wye)
< 18 s for volumes > 150 mL
< 19 s for volumes ≥ 30 mL but ≤ 150 mL
< 20 s for volumes ≥ 2 mL but < 30 mL
Measuring and display devices
Pressure Measurements:
-Type: Solid state differential pressure transducer
-Sensing position: Inspiratory module; expiratory module
-Mean airway pressure (PMEAN): -20 cmH2O (-20 hPa) to 100 cmH2O (98 hPa)
-Peak airway pressure (PPEAK):- 20 cmH2O (-20 hPa) to 130 cmH2O (127 hPa)
Volume Measurements:

MV2000 Ventilator System 145 M01-18-L190 Eng. Ver. 4.42


-Type: Hot film anemometer
-Sensing position: Inspiratory module; expiratory module
Oxygen measurement:
-Type: Galvanic cell Sensing
-position: Inspiratory module
Minute volume (VE Min) capability, ventilator: Up to 75 L/min

8.8. Technical Specification


Measured Parameter Description
A fixed pressure limit to the safety valve limits in
Maximum limited pressure circuit pressure to < 120 cmH2O at the patient
wye.
Max. Working Pressure is ensured by the high
Maximum working pressure
pressure limit when Plimit< 100 cmH2O
Response time to change in FiO2 setting
< 40 s
from 21% to 90% O2
0.2 cmH2O < resistance< 2.2 cmH2O at 30 L/min
flow
Inspiratory filter resistance
0.2 cmH2O < resistance<1.7 cmH2O at 30 L/min
flow
Expiratory filter resistance <2.5 cmH2O at 100 L/min flow
PEDIATRIC : 1.05ml/ cmH2O to 9 ml/ cmH2O
Circuit compliance
ADULT : 1.05ml/ cmH2O to 12 ml/ cmH2O
Type BF applied part Breathing Circuit, SpO2, EtCO2, Nebulizer

8.9. Delivery Accuracy


Parameter Accuracy Range
Inspiratory pressure ± ( 3.0 + 2.5 % of setting) cmH2O 0 cmH2O to 99 cmH2O
End expiratory pressure ± ( 2.0 + 4 % of setting) cmH2O 0 cmH2O to 60 cmH2O
For adult and pediatric circuit type
setttins:
For VTIDAL>100 mL, ± (10
mL+10% of setting) mL
For VTIDAL≤100ml,
For adult and pediatric circuit
± (4+10% of setting) mL
type settings:
For neonatal circuit type settings:
50 mL to 2500 mL
Tidal Volume For setting of 2 mL ± (1+10 % of
For neonatal circuit type
setting) mL
settings:
For setting of 3 mL to 5 mL ± (2+
2 mL to 200 mL
10 % of setting) mL
For setting of 5 mL to 20 mL ±
(3+15 % of setting) mL
For setting of > 20 mL ± (4 + 10 %
of setting) mL
Oxygen ± 3% 21 % to 100 %

MV2000 Ventilator System 146 M01-18-L190 Eng. Ver. 4.42


8.10. Measurement tolerance
Measure tolerance and the manner in which they are applied are listed in the following
tables unless otherwise noted.

Measured Parameter Offset Gain


Flow 0.1 LPM 3.0 % reading
Pressure 0.1 cmH2O 0.2 % reading
Oxygen Concentration 0.1 % O2 0.1 % reading
Temperature 0.1 ℃ 0.2 % reading
Atmospheric Pressure 1.7 cmH2O -

8.11. Performance-SpO2 (optional)

Probe Finger type reusable sensor

Range Of Display 0 ~ 100%

Pulse Rate 0, 30 ~ 250 bpm

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 %

Setting Time 2 sec. Max wave out time

Operating Range and Dissipation

Red Light Wavelength Approximately 660 nm


Infrared Light
Approximately 870 nm
Wavelength
Optical Output Power Less than 15 mW

Display

Display update rate 1 second

Response time < 20 seconds

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.

MV2000 Ventilator System 147 M01-18-L190 Eng. Ver. 4.42


8.12. Performance-EtCO2 (Optional)

CO2 Range 0 ~ 99 mmHg (0 ~ 19.7 %)


± 2mmHg , 0 ~ 38 mmHg
Accuracy
± 5mmHg , 39 ~ 99 mmHg
Sampling rate 50 ml/min
30 seconds (typical), reaches ± 5%
Initialization time
steady-state accuracy within 3 minute
Respiration rate 0 ~ 150 bpm

MV2000 Ventilator System 148 M01-18-L190 Eng. Ver. 4.42


8.13. Test Summary
8.13.1. Guidance and manufacturer’s declaration – electromagneti
c emissions
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.

Emissions test Compliance Electromagnetic environment - guidance

The MV2000 uses RF energy only for its internal function.


RF emissions
Group 1 Therefore, its RF emissions are very low and are not likely
CISPR 11
to cause any interference in nearby electronic equipment.

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

8.13.2. Guidance and manufacturer’s declaration


- electromagnetic immunity
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.
IEC 60601 Compliance Electromagnetic environment
Immunity test
Test level level -guidance
Floors should be wood, concrete or
Electrostatic
± 6 kV Contact ± 6 kV Contact ceramic tile. If floors are covered
discharge (ESD)
with synthetic material, the
± 8 kV air ± 8 kV air relative humidity should be at
IEC 61000-4-2
least 30 %.
Electrical fast ± 2 kV for power ± 2 kV for power
Mains power quality should be that
transient/burst supply lines supply lines
of a typical commercial or hospital
±1 kV for ±1 kV for
environment.
IEC 61000-4-4 input/output lines input/output lines

± 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

MV2000 Ventilator System 149 M01-18-L190 Eng. Ver. 4.42


on power supply requires continued operation
input lines 40 % Uт 40 % Uт during power mains interruptions,
(60 % dip in Uт ) (60 % dip in Uт ) it is recommended that the
IEC 61000-4-11 for 5 cycle for 5 cycle MV2000 image intensifier be
powered from an uninterruptible
70 % Uт 70 % Uт power supply.
(30 % dip in Uт) (30 % dip in Uт)
for 25 cycle for 25 cycle

<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.

8.13.3. Guidance and manufacturer’s declaration – electromagneti


c immunity

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.

Immunity IEC 60601 test Compliance


Electromagnetic environment - guidance
test level level
Mobile RF communications equipment should be
used no closer to any part of the MV2000,
including cables, than the recommended
Conducted separation distance calculated from the equation
RF 3 Vrms applicable to the frequency of the transmitter.
3 Vrms
IEC 61000- 150 kHz to 80
150 kHz to
4-6 MHz Recommended separation distance
80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz


3V/m
Radiated RF 3V/m
80 MHz to
IEC 61000- 80 MHz to 2.5 Where P is the maximum output power rating of
2.5 GHz
4-3 GHz the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as

MV2000 Ventilator System 150 M01-18-L190 Eng. Ver. 4.42


determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b

Interference may occur in the vicinity of


equipment marked with the following symbol :

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.

8.13.4. Recommended separation distances

The MV2000 is intended for use in an electromagnetic environment in which radiated RF


disturbances are controlled. The customer or the user of the MV2000 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the MV2000 as recommended
below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter


[m]
Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter
[W]

V1= 3 Vrms E1= 3 V / m E1= 3 V / m


0.01 0.12 0.11 0.23
0.1 0.37 0.36 0.73
1 1.17 1.16 2.33
10 3.69 3.68 7.37
100 11.66 11.66 23.33

MV2000 Ventilator System 151 M01-18-L190 Eng. Ver. 4.42


For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for 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.

Chapter 9 Configurations/Optional access


ories
9.1. Basic configurations
Adult Test Lung 600ml User’s Manual
Or. No. PG0002_00 Or. No. AS0331_01
Info. Info.
EA 1 EA 1

Ventilator Circuit Arm Monitor External Cable


Clamp
Or. No. AH0143_00 Or. No. AC0140_00
Info. Info.
EA 1 EA 1

Power cable Power Cable Clamp


Or. No. AC0017_00 Or. No. AS0330_00
Info. Info.
EA 1 EA 1

Power Fuse (250V L-Wrench 10mm


F3.15AH)
Or. No. AZ0550_01 Or. No. AS0308_01
Info. Info.
EA 2 EA 1

High pressure air hose High pressure O2 hose


(3.5m) (3.5m)
Or. No. AR0052_00 Or. No. AR0039_00
Info. Info.
EA 1 EA 1

MV2000 Ventilator System 152 M01-18-L190 Eng. Ver. 4.42


Product cover Diaphragm Silicon
Or. No. AS0316_00 Or. No. MA0222_01
Info. Info.
EA 1 EA 1

Flow Sensor Flat head screw M4*6mm


Or. No. MA0224_01 Or. No. AS0152_00
Info. Info.
EA 1 EA 4

Truss head screw M5*8mm Hex socket head cap screw


M12*30mm
Or. No. AS0346_00 Or. No. AS0398_00
Info. Info.
EA 1 EA 1

Spring washer Φ12 Flat washer Φ12


Or. No. AS0344_00 Or. No. AS0381_00
Info. Info.
EA 1 EA 1

Silicon O-RING(60018S) O2 Sensor ass'y - Installed


Or. No. AS0171_00 Or. No. MA0100_01
Info. Info.
EA 9 EA 1

9.2. Optional Accessories

Ventilator Cart Ventilator Circuit Arm


Or. No. PG0086_12 Or. No. PG0044_00
Info. Info.
EA 1 EA 1

SpO2 Sensor: WA-100 SpO2 Extension cable


(Mednis Co., Ltd.) (Mednis Co., Ltd.)
Or. No. AC0007_01 Or. No. AC0145_00
Info. Adult Info.
EA 1 EA 1

SpO2 Sensor: D-MDNA Proximal Flow sensor


(Mednis Co., Ltd.)
Or. No. PG0030_00 Or. No. PG0057_00
Info. Neonate Info.
EA 1 EA 1

MV2000 Ventilator System 153 M01-18-L190 Eng. Ver. 4.42


Breathing Circuit: Humidifier: MR850
MK140003B (F&P Healthcare)
(Vincent Medical)
Or. No. PG0074_00 Or. No. PG0032_05
Info. Adult Info.
EA 1 EA 1

Humidifier: MR810 EtCO2Sensor: IRMA


(F&P Healthcare) (Masimo)
Or. No. PG0032_02 Or. No. PG0022_00
Info. Info.
EA 1 EA 1

EtCO2 Extension cable Neonate Test Lung


(Mednis Co., Ltd.)
Or. No. AC0124_00 Or. No. PG0002_01
Info. Info.
EA 1 EA 1

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

MV2000 Ventilator System 154 M01-18-L190 Eng. Ver. 4.42


Chapter 10 Sales and Service Information
Contact Us
You can reach us through the following contact points to get detailed information on our
services and products.

[Manufacturer / Customer Service Team]


MEKICS Co., Ltd.
21, Sangjiseok-gil, Paju-si, Gyeonggi-do, Korea

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.

MV2000 Ventilator System 155 M01-18-L190 Eng. Ver. 4.42

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