MV2000 User Manualatleglobal.com/.../mtv1000_users_manualenglishrev2.3_160817.… · Eng. Ver....

Eng. Ver. 2.3 2016-08-17

User’s Manual

MTV1000 Ventilator System

User’s Manual can be modified without announcement for performance improvement. Screens and pictures on User’s Manual may be different from actual product.

MTV1000 Ventilator System 2

User’s Manual

Table of Contents

1. About User’s Manual .................................................................................................................... 5

1.1 Cautions ............................................................................................................................................ 5 1.2 Warranty ........................................................................................................................................... 5 1.3 Revision History ............................................................................................................................. 5 1.4 Symbols ............................................................................................................................................. 5

2. Precautions ..................................................................................................................................... 7

2.1. Cautions for storage .................................................................................................................. 7 2.2. Cautions when using the product ........................................................................................ 8 2.3. Cautions on Electrical Safety ................................................................................................. 9 2.4. Cautions for Electronic Safety ............................................................................................. 10

3. Appearance and Specification ................................................................................................. 11

3.1. Overview ...................................................................................................................................... 11 3.2. Appearance.................................................................................................................................. 12

3.2.1. Front View ......................................................................................................................... 12

3.2.2. Rear View .......................................................................................................................... 13

3.2.3. Left Side View ................................................................................................................... 14

3.2.4. Right Side View ................................................................................................................ 15

3.2.5. Top View ............................................................................................................................ 16

3.3. Specification ............................................................................................................................... 17 3.3.1. General Characteristics ................................................................................................... 17

3.3.2. Electric Specification ........................................................................................................ 17

3.3.3. Setting Parameter Specification ..................................................................................... 18

3.3.4. Useful Function Description ............................................................................................ 19

3.3.5. Alarm Specification .......................................................................................................... 19

3.3.6. External Specification ...................................................................................................... 20

3.3.7. Environmental Specification ........................................................................................... 20

3.4. Internal and External Symbols ........................................................................................... 21 3.5. Maintenance and Repair ........................................................................................................ 22 3.6. Cleaning ........................................................................................................................................ 23

4. Installation and Set-Up ............................................................................................................. 24

4.1. External Power Supply ........................................................................................................... 24 4.1.1. Description on Commercial Power ................................................................................. 24

4.1.2. External Battery ............................................................................................................... 25

4.2. Internal Battery ......................................................................................................................... 26 4.2.1. Power Status Indicator .................................................................................................... 27

4.2.2. Internal Battery Replacement Method .......................................................................... 28

4.3. Oxygen (O2) Supply ................................................................................................................. 29 4.4. Bacteria Filter ............................................................................................................................. 30 4.5. Movement Method .................................................................................................................... 30 4.6. Installation Guide according to Circuit Type ................................................................. 31

5. Getting Started with MTV1000 ............................................................................................... 33

5.1. General Operation Sequence ............................................................................................... 33 5.2. Quick Ventilation Operation Sequence (Dual Ventilation Mode) .......................... 35

5.2.1. Accessing the quick ventilation mode ........................................................................... 35

5.2.2. Accessing the clinical screens ........................................................................................ 36

5.2.3. Programming ventilation options ................................................................................... 37

5.3. Quick Ventilation Operation Sequence (Single Ventilation Mode) ....................... 38 5.3.1. Accessing the quick ventilation mode ........................................................................... 38

5.3.2. Accessing the clinical screens ........................................................................................ 39

5.3.3. Programming ventilation options ................................................................................... 40

6. System Management .................................................................................................................. 41

6.1. KEY Panel ..................................................................................................................................... 41 6.1.1. Encoder .............................................................................................................................. 41


User’s Manual

6.1.2. Alarm Lamp ....................................................................................................................... 41

6.1.3. Key Pad Description ......................................................................................................... 42

6.1.4. Power Status LED ......................................................................................................... 42

6.2. Vent Mode .................................................................................................................................... 43 6.2.1. Modes available with dual limb circuit .......................................................................... 43

6.2.2. Modes available with single limb circuit (External Exhalation Valve) ....................... 44

6.3. Measurement Information .................................................................................................... 45 6.4. Graphs ........................................................................................................................................... 46 6.5. Alarm Messages ......................................................................................................................... 47 6.6. Ventilation Parameter Setting ............................................................................................. 48 6.7. Monitoring menu ....................................................................................................................... 51

6.7.1. E Flow(End of Exhaled flow) ........................................................................................... 50

6.8. Graphics menu ........................................................................................................................... 51 6.9. Tools menu .................................................................................................................................. 52 6.10. Events menu ........................................................................................................................ 53 6.11. System menu ...................................................................................................................... 54

6.11.1. SETUP ......................................................................................................................... 54

6.11.2. DATE ........................................................................................................................... 55

6.11.3. Calibration .................................................................................................................. 56

6.11.4. Patient ........................................................................................................................ 57

6.12. Alarm Setting ...................................................................................................................... 58 6.13. Useful Hot-key .................................................................................................................... 60 6.14. Miscellaneous ..................................................................................................................... 61

7. Appendix ........................................................................................................................................ 62

7.1. Setting Parameter Description ............................................................................................ 62 7.1.1. Trigger Function .................................................................................................................... 62 7.1.2. Inspiratory Rise Time ........................................................................................................... 63 7.1.3. Respiratory Rate ................................................................................................................... 63 7.1.4. Apnea Time ............................................................................................................................ 63 7.1.5. PEEP ......................................................................................................................................... 63 7.1.6. I:E Ratio/ Inspiratory Time ................................................................................................. 63 7.1.7. Volume Level Setting ........................................................................................................... 63 7.1.8. Controlled / Supported Pressure Level ............................................................................. 64 7.1.9. O2 Cencentration ................................................................................................................... 64 7.1.10. Sigh Time ................................................................................................................................ 64 7.1.11. Proximal Sensor On/Off ....................................................................................................... 64 7.1.12. Mask On/Off ........................................................................................................................... 64 7.1.13. En_Sense ................................................................................................................................ 64 7.1.14. Ex_Sense ................................................................................................................................ 64 7.1.15. Predicted Body Weight ......................................................................................................... 65 7.2. Ventilation Modes ..................................................................................................................... 66

7.2.1. V-ACV(Volume Assist Control Ventilation) .................................................................... 66

7.2.2. V-SIMV(Volume based Synchronized Intermittent Mandatory Ventilation) ............. 68

7.2.3. P-ACV(Pressure Assist Control Ventilation) .................................................................. 72

7.2.4. P-SIMV(Pressure based Synchronized Intermittent Mandatory Ventilation) ........... 74

7.2.5. PRVC(Pressure Regulated Volume Control Ventilation) .............................................. 76

7.2.6. SPONT+(Spontaneous Ventilation) ............................................................................... 78

7.2.7. AUTO .................................................................................................................................. 81

7.3. Operating Theory ...................................................................................................................... 81 7.4. Accessories .................................................................................................................................. 82 7.5. Alarm Operation according to ventilation mode .......................................................... 85 7.6. SpO2 / EtCO2 Monitoring ........................................................................................................ 86

7.6.1. SpO2 / EtCO2 Connection Information .......................................................................... 86

7.6.2. SpO2 Monitoring ............................................................................................................... 86

7.6.3. EtCO2 Monitoring .............................................................................................................. 87


User’s Manual

7.7. Test Summary ............................................................................................................................ 89 7.7.1. Guidance and manufacturer’s declaration - ................................................................. 89

electromagnetic emissions ............................................................................................................ 89

7.7.2. Guidance and manufacturer’s declaration – ................................................................. 89

electromagnetic immunity ............................................................................................................. 89

7.7.3. Guidance and manufacturer’s declaration – ................................................................. 90

electromagnetic immunity ............................................................................................................. 90

7.7.4. Recommended separation distances ............................................................................. 92

7.8. Product Warranty Policy ........................................................................................................ 93


User’s Manual

1. About User’s Manual

This user’s manual is provided to users with MTV1000 Ventilator product.

Since this user’s manual is compatible with MTV1000 Ventilator, it may not be used with other

products manufactured by our company. In case of loss or damage in user’s Manual, you may

refer to MEK-ICS web site for downloading the manual file.

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

MTV1000 user’s manual includes precautions and risks to users prior to use of ventilator.

Please read all precautions for use thoroughly before operating the product.

You may easily find information with the table of contents during operation.

If you have any inquiries on details of the product, contact our company or visit Customer

Service Center.

1.1 Cautions This document contains proprietary information that is protected by copyright.

Under copyright law, this document cannot be reproduced, modified or otherwise amended

without prior approval.

1.2 Warranty Contents in this publication may change without notice.

MEKICS takes no responsibility for any problems and damages caused by performance or

different data from the details of this document.

1.3 Revision History The part numbers and revision number indicated in this document represent the current

version.

The revision number does not change even if any subdocuments are revised.

The revision number may change when major part numbers or technical information in the

document change.

1.4 Symbols Symbols appear on the interior and exterior of the product and in this User Manual.

The symbols represent important cautions and advice to the user. Please read the following

symbols carefully and be well informed of them for the use and storage of the product.

DANGER

This symbol represents “DANGER.”

It is associated with possible matters that may greatly harm the product or the patient, or

might even cause the patient’s death.

WARNING

This symbol represents “WARNING.”

It is associated with possible matters that may harm or cause irreversible damage to the

product or the patient.

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


User’s Manual

CAUTION

This symbol represents “CAUTION.”

It is associated with possible matters that may damage the product or harm the patient.

ATTENTION

This symbol is associated with safety issues that the user should give attention to and be

well informed of before using the product. How to use the product is described in each

section of this manual.

NOTE

This symbol is associated with issues you should note regarding the surrounding

environment or additional references to the descriptions in this manual. It does not pertain

to possible damages to the product or the patient.

▣ This User Manual may differ from the actual product in terms of functionality.

▣ If deemed necessary, the company may make any improvement to the product to enhance

its performance, without prior notification, MEKICS has no obligation to apply the same

specification change to the products already sold.


User’s Manual

2. Precautions

2.1. Cautions for storage Below are precautions for storage.

Prior to using the product, user must check the surrounding environment.

WARNING

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

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

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

Do not store the product in a place with extreme thermal variation. (Proper storage temperature: -20C–50C)

Do not store the product in a very humid place or in a place with

poor ventilation. (Proper storage humidity: 10%–90%)

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.

Do not store the product in a place where the product could be

exposed to chemicals or explosive gases.

Be careful to prevent dirt, especially metal materials, from getting

inside the product.

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.

Turn off the product when you do not use it for a while.


User’s Manual

2.2. Cautions when using the product

The following are cautions when using the product. Please read them thoroughly before

use.

WARNING

1. It is extremely dangerous to use or store the product in a place exposed to chemicals

or explosive gases.

2. Do not disjoint or disassemble the product, doing so will cancel the product warranty.

3. Do not connect the product to a power supply before completing the installation. This

may damage the product.

4. Before using the product, ensure that the settings of all the sensors and functions are

correct. Only authorized, well-informed personnel should use the Ventilator unit.

5. The proper functionality of the product should be verified regularly.

6. Do not use the product on more than one patient at a time.

7. Do not use the product in a place exposed to high humidity.

8. It is very dangerous to operate the product with wet hands.

9. Do not use the product in a place exposed to direct sunlight.

10. Do not use the product in a place with extreme temperature variations.

The proper temperature ranges from 10C to 40C.

11. Do not use the product near a heating device.

12. Do not use the product in a very humid place or a place with poor ventilation.

13. The proper humidity ranges from 0% to 95%.

14. Do not use the product in a place where the product could be exposed to extreme

impact or vibration.

15. Be careful to prevent dirt, especially metal materials, from getting inside the product.

CAUTION

1. This product is used to determine patient status. Other clinical information must be

used together for accurate diagnosis.

2. Take care not to cause pain on patients from tightening sensors. Also, take care not

to tangle patients with sensor cables.

3. If measurement values displayed on the screen are considered inaccurate, measure

another patient for comparison.

4. Do not use one product on two patients simultaneously.


User’s Manual

2.3. Cautions on Electrical Safety

The following are cautions on electrical safety. Please read carefully before using the

product.

WARNING 1. The rated power input for this product is AC 100~220V / 50–60Hz. 2. Connect the power plug to an AC power outlet with an earth terminal. 3. Note that neither the company nor any representative of the company will be

responsible for any issues arising from the use of any power source out of the rated power input.

4. Only authorized personnel who are trained to service the product may disassemble the product. Note that neither the company nor any representative of the company will be responsible for any electric shock, short circuit or product damage caused by unauthorized disassembly. Failure to comply will cancel the product warranty and make the product ineligible for service.

5. If the power cord or sensor cable is damaged, immediately stop using the product and replace the power cord or cable. Using the product when the power cord or sensor cable is damaged may cause an electric shock, short circuit, current leakage or product damage.

6. Do not bump or move the product while the power cord or sensor cable is connected to it. This may cause patient injuries or product malfunctions.

7. When using the product with other devices, use a separate AC power source for the other devices to ensure the patient’s safety.

8. Do not use an anti-electrostatic or conductive tube for the product. 9. Auxiliary equipment and accessories provided by MEKICS are qualified items that

meet electrical safety standards. The use of other companies’ products or unproven items may cause injury to the patient or product damage.

CAUTION

Only use auxiliary equipment provided by the MEKICS Head Office or MEKICS’

designated representatives.

ATTENTION

1. This product uses 10.8V, 4400mAh (2ea), Li-ion battery.

2. When charging battery, connect the AC cable. Take care to prevent metal substances

from contacting the battery charging terminal.


User’s Manual

2.4. Cautions for Electronic Safety The following are cautions on electromagnetic wave safety. Please read carefully before

using the product.

The product is Electromagnetic Wave Safety Standard CLASS II-A qualified.

WARNING

1. A strong electromagnetic wave may affect the performance of the product.

Basically, the product is designed to not suffer functional disorders by surrounding

electromagnetic waves. Notwithstanding, strong electromagnetic waves may cause

the product to malfunction. This may include displaying incorrect calculation values,

disappearance of measurements and noises affecting the wave pattern. If such

errors continue, contact the MEKICS Technical Service Center or authorized dealers

for assistance.


User’s Manual

3. Appearance and Specification

This chapter provides information on the appearance and specifications of the MTV1000

ventilator System.

.

3.1. Overview This product is a ventilator for adults, pediatric, which configures breathing method, tidal

volume, Respiratory, oxygen concentration and breathing ratio to resolve the hypoxia

shown in pulmonary emphysema or respiratory disease patients. Though the ventilator can

safely manage breathing in a patient using various alarm functions and safety devices,

other clinical information must be used simultaneously for precise diagnosis of patients.

Display

This product displays various ventilation information of the patient on a 7-inch color

TFT LCD. The LCD displays graphs of pressure, volume and flow, as well as

measurement values of the patient. In addition, it is extremely easy to access menu

through touch screen and encoder. Real-time graphs and values can be saved and

represented using trend function, along with various warning messages.

When an alarm sounds function is turned off, an alarm is displayed visually on the

screen.

Electric Performance

The rated voltage of this product is 100VAC – 240VAC. In case of problems in input

power, fuse internalized in the product can be used to protect the product.

Battery pack (Li-ion battery, 10.8V, total 8800mAh) applied to the product includes two

large capacity batteries. The product can be operated up to three hours without AC

power supply. The battery remaining status is displayed at the bottom of the screen. In

addition, the battery pack can easily be attached and detached.

The battery pack can be charged by connecting AC power (100VAC – 240VAC) from

external sources. The battery can be charged more quickly with power-off status.

Connection of External Instruments

Equipment connected to the SIP/SOP on the EUT shall either comply with IEC 60601-1

or shall allow the system to comply with IEC 60601-1-1.


User’s Manual

3.2. Appearance 3.2.1. Front View

No. Part Name Description

A LCD Monitor Displays the status of ventilator system and patient

B Key Panel Includes various input buttons and encoder to handle the

ventilator

C Speaker Creates various sounds such as alarms and warnings

D Alarm

Status LED

Displays alarm status using LED colors

Normal : Green / Alarm : Red, Blue

E Power

Status LED

Displays power currently used

AC Power : Green / Battery Power : Orange

A B

C

E D


User’s Manual

3.2.2. Rear View


A Battery Cover Cover used to replace battery

B O2 Change Cover Cover used to replace O2 cell

WARNING

Be careful about polarity when replacing the battery. If polarity is reversed, the product

can be damaged. Prevent the terminal from contacting metals.

For batteries, auxiliary products designated by our company must be used.

A

B


User’s Manual

3.2.3. Left Side View


A SpO2 Port Connects SpO2 Probe

B EtCO2 Port Connects EtCO2 module

C Inspiration Port Output port of gas supplied to the patient is connected to

the patient through a circuit

D Expiration Port Input port of gas coming out of the patient is connected

to the patient through a circuit

E Proximal

Pressure Input Connects proximal pressure line

F

Exhalation

Drive Line

Outlet

Connects Exhalation Valve Control line

G Nebulizer Port

(Option) Connects Nebulizer Accessory

WARNING

If you do not use the Proximal Pressure Port should not cover.

C

D

A E

F

B

G


User’s Manual

3.2.4. Right Side View


A External

Battery Input Terminal connecting external battery

B AC Inlet Connects AC power cord

C Power Switch Standby power on / off

D COMM RS-232 communication port

E Low Flow O2

Supply Inlet Connects oxygen concentrator

F Air Filter Filters inhaled air gas

G High Pressure

O2 Supply Inlet Connects high pressure oxygen tank

ATTENTION

Do not touch RS-232 Port, Video Output Port, USB-A Type Port, and USB-B Type Port with

metal substances. Also, turn off the power when connecting cables to these ports.

B

F

G

C

D

A

E


User’s Manual

3.2.5. Top View


A Handle Handle for easy movement of ventilator

B Port Cover Cover to protect ports for external communication

B

A


User’s Manual

3.3. Specification

3.3.1. General Characteristics User-friendly menu configuration

Easy menu setting with encoder and touch screen

Two alarm functions (speaker, buzzer)

External battery can be used

3.3.2. Electric Specification

Commercial power input 100 ~ 240 VAC, 50/60 Hz

Fuse capacity 250V / 6.3A

Power consumption 150 VA

External battery input 12VDC @ 7A lead battery

Internal battery 10.8V, 4400mA Li-ion battery 2 EA

(Total 8800mAh)

Three hours of use under normal operation

Charging time: Up to four hours

Replaced after two years of use

Communication Upgradable (MAIN, Pneumatic board)

Display 7” LCD (Resolution: 800 * 480)


User’s Manual

3.3.3. Setting Parameter Specification

Item Range Measurement Condition Default Value

BW 10 ~ 150 kg (Volume)

1 ~ 150 kg (Pressure)

Inspiratory

Pressure 5 ~ 80 cmH2O

± (1.7 + 4% of the actual

reading) cmH2O 20 cmH2O

PEEP 0 ~ 50 cmH2O ± (1.7 + 4% of the actual


Inspiratory time 0.2 ~ 9.9 sec ± 10 % 1.7 sec

Enable inhalation

trigger(EnSENS) 10 ~ 80 % - 30 %

Exhalation trigger

sensitivity(ExSENS) 10 ~ 80 % - 30 %

Pressure Support 0 ~ 60 cmH2O ± (1.7 + 4% of the actual


Trigger sensitivity

Pressure OFF, 0.5 ~ 20 cmH2O - 3 cmH2O

Trigger sensitivity

Flow OFF, 0.5 ~ 20 lpm - 7 lpm

Tidal Volume 50 ml ~ 2500 ml ± 15 % (VTIDAL>100ml)

±20ml (VTIDAL≤100ml) 10 ml/kg

Rate 2 ~ 60 bpm ± 2 bpm 12 bpm

O2 % 21 ~ 100 % ± 3 % 30 %

Sigh OFF/30/60/90/120 RPB OFF

BTPS OFF, MANUAL

DRY/MANUAL HUMID - -

MASK ON/OFF - -

Proximal Pressure

Sensor(Option) ON/OFF - -

Limb Type Single with Ex.Valve /

Dual - -

Pressure Limit 5 ~ 80 cmH2O ± (1.7 + 4% of the actual


V SENS 20 ~ 500 ml - 100ml

Nebulizer(Option) 10~180min - 30 min

Trise Fast, Medium, Slow - Fast


User’s Manual

3.3.4. Useful Function Description

Function Description

Inspiration pause Measures patient’s lung resistance, compliance, elasticity, time

constant

Manual Inspiration Delivers one mandatory breath

Touch-Key lock Disable touch-key function

Graph freeze Freezes waveform & loop graphs

Alarm silence Turns off alarm sound for 2 minutes

Alarm reset Clear active alarms

Sound Volume Controls alarm sound volume

3.3.5. Alarm Specification

Item Range

PRESSURE HIGH OFF, 0 cmH2O ~ 120 cmH2O

PRESSURE LOW OFF, 0 cmH2O ~ 110 cmH2O

VTIDAL High OFF, 20 ml ~ 2500 ml

VTIDAL LOW OFF, 10 ml ~ 2400 ml

O2 HIGH OFF, 0% ~ 100%

O2 LOW OFF, 0% ~ 80%

RATE HIGH 2 ~ 150 BPM

RATE LOW 0 ~ 148 BPM

VE MIN HIGH 0.5 ~ 50 LPM

VE MIN LOW 0.0 ~ 49.0 LPM

O2 Pressure Fail -

AIR LEAK 10 ml ~ 500 ml, OFF

APNEA 2 ~ 60 sec

VENT INOP -

O2 CELL ERROR -

CIRCUIT OPEN -

BATTERY MODE -

LOW BATTERY DC power loss

COM ERROR -

SpO2 High(optional) OFF, 52 ~ 100%

SpO2 Low(optional) 51 ~ 100%

PR High(optional) 26 ~ 250 bpm

PR Low(optional) 25 ~ 249 bpm

EtCO2 High(optional) 0.0 ~ 15.0 %

EtCO2 Low(optional) OFF, O.O ~ 14.9%

INS High(optional) 0.0 ~ 15.0 %


User’s Manual

INS Low(optional) OFF, 0.0 ~ 14.9 %

RESP High(optional) 3 ~ 150 rpm

RESP Low(optional) 2 ~ 149 rpm

3.3.6. External Specification

Main body size 25 x 15.6 x 37.1 (Width x Depth x Height) cm

Main body mass 8 Kg

Inspiratory limb connector ISO 22mm conical male

Expiratory limb connector ISO 22mm conical male

Oxygen supply inlet DISS male / female

3.3.7. Environmental Specification

Operating Temperature range 10 to 40 ℃ (50 ~ 104 ℉)

Operating Atmosphere Pressure range 700 to 1060 mbar (10.2 ~ 15.4 psi)

Operating Altitude range Up to 3000 m (9,842 ft)

Operating Humidity range 0 to 95 %

Storage Temperature range -20 to 50 ℃

Storage Atmosphere Pressure range 500 to 1060 mbar (7.3 ~ 15.4 psi)

Storage Altitude range Up to 6560 m (20,000 ft)

Storage Humidity range 10 to 90 %

O2 supply pressure range 2.56 ~ 7.3 Kgf/㎠

or 2.4 ~ 6.9 bar

or 35 ~ 90 psig

International Standards

This product selected and acquired the following international standards.

EN60601-1:1990 Electric Safety

EN60601-1-1:2001 Electromechanical Safety

EN60601-1-2:2001 Electromagnetic Compatibility Requirement and tests

IEC 60601-2-12:2001 Particular requirements for the safety of lung ventilators for medical

use


User’s Manual

3.4. Internal and External Symbols

Symbols used on the interior and exterior of the product are described. Check description

on each symbol prior to using the product.

No. Name Symbol Description

1

Attention

Consult

accompanying

document

This symbol indicates that user must

consult accompanying document

(User’s Manual) prior to operation.

IEC 60601-1

2 Stand-By

This symbol indicates that the device is

in stand-by to use its functions.

IEC 417-5009

3 AC power plug

This symbol displays AC plug without

ground poles. This is for AC power.

IEC 417-5534

5 AC Power

AC Power Operation

4 Battery Power

Battery Power Operation

5 External battery This symbol indicates external battery.

6 Graph Freeze

Freezes currently displayed graph.

7 Exit

Removes menu tree from the screen.

8 Alarm silence

Turning off audible alarm sound for two

minutes

9 Alarm reset

Resetting alarm LED and messages

10 Alarm sound Off

Alarm sound is off or mute.

11 Touch-key unlocked

Enable touch-key function

12 Touch-key locked

Disable touch-key function

13 Manual Inspiration

Delivering one mandatory inspiration

14 Nebulizer

(Option)

Nebulizer is turned On/Off.


User’s Manual

3.5. Maintenance and Repair

Period of regular inspection and maintenance on this device and patient circuit system are

as described in the following table.

Period Subject Details

Daily

All bacteria filters

- Inspiratory filter

- Expiratory filter

Inspect whether all filters are

normally attached

Patient circuit system

Inspect connection state,

leakage, clogging, and

moisture

Collector vial, gas supply water

traps

Check moisture state and

empty it if necessary

When patient is changed, or at

least once every 15 days

Patient circuit system, all

bacteria filters, and

humidification chamber

After replacement, used parts

are cleaned and sterilized

Every 6 months Entire equipment Perform test

Every year or after 100 times

of autoclave All bacteria filters

Replacement to new filters and

disposal of used filters

Between 1 ~ 2 years Oxygen cell Replacement to new cell

Whenever necessary Oxygen cell Oxygen cell calibration using

O2/CAL button

Every 10,000 hours Various auxiliary products Replacement of parts using

10,000 Hours Service Kit.

CAUTION

User must inspect installation state and abnormalities in filters and patient circuit system

every day with unaided eyes. If abnormalities are found, corresponding parts must be

immediately supplemented or replaced.

CAUTION

When changing the patient or every 15 days when using the product long-term for a

patient, patient circuit system including all bacteria filters must be replaced. Used parts

must be cleaned and sterilized.

CAUTION

All components of patient circuit system excluding bacteria filters can be sterilized using

any of ETO (ethylene oxide) gas method, steam autoclave method, and chemical

sterilization method.

However, only steam autoclave method can be used for bacteria filters. Sterilization is

performed for about 20 minutes at 132˚C.

CAUTION

Bacteria filters must be replaced to new filters every year or when the number of

autoclaves reaches 100. For oxygen sensor, lifespan may be reduced by high FiO2 or high

temperature.


User’s Manual

3.6. Cleaning

Regular cleansing prevents problems in function and performance of this product.

Take the following steps to avoid contamination and unnecessary damage.

WARNING

1. If undesignated, dangerous substances are used for cleaning, no free repair service

will be provided on the damaged product regardless of warranty period.

2. Take care on the main body and sensors after cleaning. Do not use damaged or

aged device.

3. Once a month, clean the exterior of the product using soft cloth soaked in warm

water or alcohol.

4. Do not use lacquer, paint, thinner, ethylene or oxidizer that may damage the

product.

5. Do not place accessories in liquids or detergents.

6. Take care to prevent liquids from entering the product or sensor probe during use.

WARNING

1. Do not arbitrarily dispose of the product.

2. Do not discard disposable sensor in places with risks.

3. Be careful about environmental contamination.


User’s Manual

4. Installation and Set-Up

When installing or moving the device, be careful not to place impact on the product.

4.1. External Power Supply External commercial power or battery power can be used.

4.1.1. Description on Commercial Power External commercial power connector is on left side of the product.

WARNING

If rating is incorrect, user and product can be damaged.

Power cord must be connected to the outlet attached to the ground.

Damaged power cord or sheath must be replaced.

When external DC power or AC power is connected, power LED is turned on indicating

which power is being supplied.


User’s Manual

4.1.2. External Battery

External battery connector pinout is as follows.

Pin Name Description

1 Not connected

2 Not connected

3 GND Grounding

4 +VCC External battery input

CAUTION

Do not short any pins of Ext. Batt. Connector. It may damage internal electric circuit.

Be careful about polarity when connecting and replacing batteries.

Use rated voltage of 12V DC and current must be 7A or above.

WARNING

Fuse is internalized in the product.

Time Lag Type, 250V, 6.3A

NOTE

Internal battery is not charged while external battery is being used.

1

2

3

4


User’s Manual

4.2. Internal Battery Internal battery is used to supply power to the product when the patient is moving.

Battery is automatically charged when external commercial power is supplied. Once

commercial power supply is terminated or power supply is suspended accidentally, power

is automatically switched to internal battery. Remaining battery status is indicated on the

LCD.

WARNING

Battery must be charged before use. Replace the battery if it is considered inadequate.

If battery gets low, measurement information relating ventilation may result in errors. If

remaining battery is low, connect to commercial power.

Be careful about polarity when replacing battery. Connect (+) to red and (-) to black. If

polarity is mistaken, it may damage the product.

Do not short battery terminal. (Battery may explode and cause harm on human body)

Use rated voltage and current. (10.8V, 4400mA)

In case of abnormality in battery, contact [Customer Service team] to receive necessary

follow-up.

CAUTION

Fuse is internalized in the product.

Time Lag Type, 250V, 6.3A

Internal battery can be influenced by the number of discharges during use, degree of

discharge, surrounding temperature, and charging voltage. Battery can ordinarily be used

for two years.


User’s Manual

4.2.1. Power Status Indicator This symbol shows current power status. It is displayed on the bottom right side of the

LCD screen. The status is classified into 5 states.

No. Figure Description

1

AC power on

2

Battery remains 80% ~ Full

3

Battery remains 50% ~ 80%

4

Battery remains 20 % 50%

5

Battery remains Empty ~ 20%.

With this status, the symbol keeps blinking and

beep sound is made. To protect the battery, power

is automatically blocked and the device is turned off

after about five minutes.

NOTE

When the product is used over two hours with internal battery, ventilator may not operate

properly. Measurement values such as TIDAL Volume can be relatively small.


User’s Manual

4.2.2. Internal Battery Replacement Method


1

Unscrew the six screws on both sides of the

battery cover.

2

After removing battery cover, separate battery

pack.

3

There are two batteries. Replace the wanted

battery and assemble in a reverse sequence.

WARNING

Place battery connector in the correct position when replacing battery. If the connector is

misplaced, it may damage the product.

CAUTION

All bolts are tightened clockwise and loosened counterclockwise.


User’s Manual

4.3. Oxygen (O2) Supply

Oxygen gas can be supplied in two ways. One is using high pressure O2 port, and the other

is low flow O2 port.


1

High Pressure O2 supply

2

Low flow O2 supply

WARNING

Since oxygen tank pressure is high, always keep oil away from connector to prevent

explosion.

Before connecting or disconnecting high pressure hose, close oxygen tank valve first.

Check that high Pressure O2 supply pressure is appropriate (35~90 PSI).

High pressure hose must be kept away from people during use and transportation.

If low flow O2 supply is not used, keep low flow O2 port closed up.


User’s Manual

4.4. Bacteria Filter Bacteria filter is used for patient safety.

WARNING

Filter must be used before connecting the device to the patient.

If accessory has symbol, it is disposable and must not be reused.

In order to use reusable accessories, sterilize and clean them first.

Filters must be provided and designated by our company. Consult with hospital supply

engineer or locally authorized seller when using other products.

This product must only be operated with authorized standard products. Our company is

not responsible for problems caused by use of unauthorized products.

Since accessories are aseptic products, packages must only be opened before use. There

must be no flaws or defects in the packages.

4.5. Movement Method


1

Move the product using handle.

WARNING

When moving the product, keep the LCD frontal. Prior to moving, make sure that parts and

power cords are arranged.

WARNING

When using cart, disable the lock that fixates wheels on the product before movement.

Lock the wheels after movement.

2


User’s Manual

4.6. Installation Guide according to Circuit Type

Circuit Type A. Dual limb circuit without external Exhalation Valve

(Non-vented Mask Type)

Circuit Type

MASK Type

Proximal

Pressure Port

Mask

without Exhalation

Hole

Mask

with Exhalation

Hole

Dual limb circuit O X O

Single limb circuit

with Exhalation valve O X O

MENU SETUP

– Limb Type

MODE SETTING

- MASK ON or OFF

SETUP

- Proximal ON/OFF


User’s Manual

Circuit Type B. Single limb circuit with external Exhalation Valve

(Non-vented Mask Type)


User’s Manual

5. Getting Started with MTV1000

5.1. General Operation Sequence

No. Item Figure Description

1

Preparing

patient circuit

and accessories

Refer to “Installation Guide according

to Circuit Type”

Connect Patient circuit and

appropriate accessories to the

product.

2 Preparing power

A. Connect power cord to AC

power inlet. AC commercial

power LED is turned on.

B. Position power switch at stand-

by symbol.

C. System fail buzzer sound is

created.

3 Turning on power

When stand-by switch is pushed for

two seconds, power is normally

supplied and system fail sound

disappears. Wait for preparation of

various sensors.

Screen state: “Initial” word is

displayed at first. Afterwards

“Ready” appears.

CAUTION

Buzzer alarm sound is created when power switch is positioned at stand-by.

If there is no buzzer sound, check the problem in power supply and fuse.


User’s Manual


4

Selecting

Patient

Type

A. Add a new patient

or load last patient

setting.

B. Select patient type.

C. If height of the

patient is decided,

PBW (predicted

body weight) is

automatically

calculated.

5

Selecting

Ventilation

Mode

A. Click “READY”

button to see

ventilation modes

screen.

B. Select appropriate

ventilation mode.

For more details,

refer to “Vent.

Mode” section.

6

Selecting

Ventilation

Parameter

A. Set appropriate

parameters for

selected vent mode.

B. Push accept button

to start ventilation.

A

B

C

A

B

A

B


User’s Manual

5.2. Quick Ventilation Operation Sequence (Dual

Ventilation Mode)

MTV1000 allows you to save two sets of ventilation parameters. Only physicians and

competent nursing, technical staff are permitted to access the clinical screens. The patient

must not handle clinical screen directly.

5.2.1. Accessing the quick ventilation mode


1

Entering

Quick

ventilation

mode

A. Select “System”

menu ->

“Patient” button.

B. Input the SVC

Code “97”.

C. Push “Enter” key.

Then ventilator

will change the

Quick ventilation

mode.

2

Standby

Screen

Changing

Normal Mode Initial

Standby screen will

change the Quick

mode Initial Screen.

3

Quick

Ventilation

Mode

Press directly on the

appropriate screen

icons to access

display screens and

select parameters

(M1 or M2)

4

Standby

Screen

Rechanging


menu ->


B. Reinput the SVC

Code “97”.


The ventilator will

change the

normal

ventilation mode.

B

C

A


User’s Manual

5.2.2. Accessing the clinical screens

Only physicians and competent nursing, technical staff are permitted to access the clinical

screens. The patient must never be told how to access these screens.


1

Entering

Clinical

Screens

A. Select “System” menu -

> “Patient” button.

B. Input the SVC Code

“98”.

C. Push “Enter” key. Then

ventilator will change the

clinical screens.

2 Clinical

Screen

The Clinical screen will

display.

3

Entering

Quick Mode

Screens

A. Select “System” menu ->


B. Input the SVC Code “99”.


ventilator will change the

Quick Mode Screens.

B

C

A

A

B

C


User’s Manual

5.2.3. Programming ventilation options

MTV1000 allows you to save two sets of ventilation parameters. From the main clinical screen

you can modify the M1 and M2 ventilation mode. When you have entered a program you can

make the desired modifications. There modification is automatically saved when you exit the

clinical setting menu.


1

Selecting a

ventilation

program to

setup

A. Select M1 or M2 ventilation

program.

B. Select “Setting” Button.

2

Selecting

Patient type

& Height

C. Select Patient type.

D. Input patient height with

encoder.

E. Push “Next” Button.

3

Program

Ventilation

Value

F. Setup M1 ventilation value.

G. And push “SAVE” button will

save M1 ventilation value.

“M2” setup is the same way

to “M1”.

B

A

B

C

A

A


User’s Manual

5.3. Quick Ventilation Operation Sequence (Single

Ventilation Mode)

MTV1000 allows you to save two sets of ventilation parameters. Only physicians and

competent nursing, technical staff are permitted to access the clinical screens. The patient

must not handle clinical screen directly.

5.3.1. Accessing the quick ventilation mode


1

Entering

Quick

ventilation

mode


menu -> “Patient”

button.

B. Input the SVC

Code “95”.


Then ventilator

will change the

Quick ventilation

mode.

2

Standby

Screen

Changing

Normal Mode Initial

Standby screen will

change the Quick

mode Initial Screen.

3

Quick

Ventilation

Mode

Press directly on the

appropriate screen

icons to access

display screens and

select parameters

(M1)

4

Standby

Screen

Rechanging

D. Select “System”

menu ->


E. Reinput the SVC

Code “95”.

F. Push “Enter” key.

The ventilator will

change the

normal ventilation

mode.

B

C

A


User’s Manual

5.3.2. Accessing the clinical screens

Only physicians and competent nursing, technical staff are permitted to access the clinical

screens. The patient must never be told how to access these screens.


1

Entering

Clinical

Screens

A. Select “System” menu

-> “Patient” button.

B. Input the SVC Code

“98”.


ventilator will change

the clinical screens.

2 Clinical

Screen

The Clinical screen will

display.

3

Entering

Quick Mode

Screens

D. Select “System” menu -

> “Patient” button.

E. Input the SVC Code

“99”.

F. Push “Enter” key. Then

ventilator will change

the Quick Mode

Screens.

B

C

A

A

B

C


User’s Manual

5.3.3. Programming ventilation options

MTV1000 allows you to save one set of ventilation parameters. From the main clinical screen

you can modify the M1 ventilation mode. When you have entered a program you can make

the desired modifications. There modification is automatically saved when you exit the clinical

setting menu.


1

Selecting a

ventilation

program to

setup

A. Select M1 ventilation

program.

B. Select “Setting” Button.

2

Selecting

Patient type

& Height

C. Select Patient type.

D. Input patient height with

encoder.

E. Push “Next” Button.

3

Program

Ventilation

Value

F. Setup M1 ventilation

value.

G. And push “SAVE” button

will save M1 ventilation

value.

B

A

B

C

A

A


User’s Manual

6. System Management

6.1. KEY Panel

6.1.1. Encoder Spin the encoder on key panel to select wanted menu or configure wanted setting value.

Click the encoder button to select sub menu or save setting value.

6.1.2. Alarm Lamp

CAUTION

Once alarm occurs in the device, red light blinking. This light is kept on until user pushed

“RESET” button even after the condition is removed.

Turn Left

-Descend menu

-Decrease setting value

Turn Right

-Elevate menu

-Increase setting value

Click

Select menu, save setting value

Status Figure Color Description

NORMAL

GREEN

Light is turned on if ventilator is

being operated normally and

there is no alarm.

WARNING

RED

BLUE Alarm has been occured


User’s Manual

6.1.3. Key Pad Description

6.1.4. Power Status LED


1 AC POWER ON LED

Once AC commercial power is supplied, “AC

POWER ON LED” is turned on. Internal

battery begins to charge.

2 BATTERY ON LED

If AC power is blocked, internal battery starts

to operate and “BATTERY ON LED” is turned

on.

CAUTION

If “AC Power ON LED” and “Battery ON LED” are both OFF, internal battery has run out.


1 Standby

Switch

1. Push for one second to turn power ON. Push for 10

seconds to turn power OFF.

2. Set ventilation mode to standby.

2 Alarm 2 Min

Auditory alarm signal is not created for two minutes.

3 Alarm Reset

Existing alarm LED is turned off and alarm messages

disappears.

4 Exit

Exit from current menu.


User’s Manual

6.2. Vent Mode Vent mode can be configured by selecting “READY” Button on the top right corner of the screen.

6.2.1. Modes available with dual limb circuit

P-ACV Pressure Assist Control Ventilation

P-SIMV Pressure Synchronized Intermittent Mandatory Ventilation

SPONT+ Spontaneous Ventilation

PRVC Pressure Regulated Volume Control Ventilation

V-ACV Volume Assist Control Ventilation

V-SIMV Volume Synchronized Intermittent Mandatory Ventilation

AUTO This mode provides quick start of ventilation based on PBW(Predicted

Body Weight). P-ACV or V-ACV modes are available.

NOTE

For more details on the mode, refer to Appendix.1 Ventilation Mode Specification


User’s Manual

6.2.2. Modes available with single limb circuit (External Exhalation Valve)

P-ACV Pressure Assist Control Ventilation

P-SIMV Pressure Synchronized Intermittent Mandatory Ventilation

SPONT+ Spontaneous Ventilation

PRVC Pressure Regulated Volume Control Ventilation

V-ACV Volume Assist Control Ventilation

V-SIMV Volume Synchronized Intermittent Mandatory Ventilation

AUTO This mode provides quick start of ventilation based on PBW(Predicted

Body Weight). P-ACV or V-ACV modes are available.

NOTE

For more details on the mode, refer to Appendix.1 Ventilation Mode Specification


User’s Manual

6.3. Measurement Information

Measurement information relating to ventilation is displayed on the left of the screen.

Measurement information list differs according to the ventilation mode. VTE, VE MIN, RATE,

PAW, and PEEP are displayed basically.

Other information can be checked by selecting “Monitoring” button. Refer to “Monitoring”

section for details.

Measurement Information


User’s Manual

6.4. Graphs

Pressure, flow, and volume waves are measured and displayed along with various trend

graphs.

Display layout can be changed in “Graphics” menu. For more details, refer to “Graphics”

section.

Wave Graphs


User’s Manual

6.5. Alarm Messages

When alarm message occurs, cause of the alarm should be checked and resolved

immediately. Refer to the following table for more details.

Message Description Cause Solution

O2 FAIL O2 FAIL

O2 supply is not connected Inspect O2 supply connection.

O2 supply pressure is out of

range (35~90psi). Check O2 supply pressure.

VENT INOP Ventilator system is in-

operation.

Blower is defective Contact customer service team.

Sensor is defective.

O2 CELL ERR Problem of O2 cell O2 cell is defective. Replace O2 cell.

CIRCUIT OPEN Patient circuit is open. Leakage in circuit Inspect circuit connection.

Battery Mode Battery power is on. AC Power loss. Connect AC power.

Power board is defective. Contact customer service team.

COM ERROR

Inter-communication

error has been

occurred.

Cable is defective. Contact customer service team.

AIR LEAK Air is leaking. Leakage in circuit. Replace circuit.

Leakage in block. Contact customer service team.

LOW BATTERY Battery ran out. Battery is defective. Replace battery.

AC Power loss. Connect AC power

Alarm Messages


User’s Manual

6.6. Ventilation Parameter Setting

Once ventilation starts, parameter setting list for the current ventilation mode is displayed

on the right of screen. The setting list varies according to ventilation modes. Value of each

parameter can be changed using touch or encoder, and the change goes into effect

immediately.

Setting list according to ventilation mode is as below.

Vent. Mode Setting list

V-ACV VTIDAL, RATE, PEEP, O2

V-SIMV VTIDAL, RATE, PEEP, O2

P-ACV PINSP, RATE, PEEP, O2

P-SIMV PINSP, RATE, PEEP, O2

PRVC VTIDAL, RATE, PEEP, O2

SPONT+ PS, APNEA Time, PEEP, O2

AUTO Identical to V-ACV Mode or P-ACV Mode Setting.

Parameter Setting List


User’s Manual

6.7. Monitoring menu “Monitoring” menu shows all measuring information comprehensively.

Table 1 shows details on ventilation. Table 2 shows details on SpO2 and EtCO2.

Monitoring list according to ventilation mode is as below.

Item Unit Description

Paw cmH2O Airway pressure

P PEAK cmH2O Maximum inspiratory pressure

P MEAN cmH2O Mean airway pressure

P PAUSE cmH2O Pause inspiratory pressure

PEEP cmH2O Positive end expiratory pressure

Auto PEEP cmH2O Difference between measured PEEP and configured PEEP

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 Respiratory

RR SPONT BPM Respiratory rate in spontaneous breath

VEMIN

SPONT

LPM Expiratory volume per min in spontaneous breath

TI sec Inspiration time

TE sec Expiration time

I : E Inspiration to expiration ratio

Ex.End Flow LPM Expiration flow

RSBi b/min/mL Rapid shallow breathing index

O2 % Oxygen concentration in volume %

CL mL/ cmH2O Compliance

WOBv J/L Work of Breathing Ventilator

PR BPM Pulse Rate

SpO2 % Oxygen saturation in blood


User’s Manual

EtCO2 mmHg End tidal carbon dioxide

iCO2 mmHg Inspiratory carbon dioxide

RESP RPM Respiratory through EtCO2

VI CO2 Ml Inspiratory CO2 Tidal Volume

VE CO2 Ml Expiratory CO2 Tidal Volume

VE MIN CO2 Ml Expiratory Minute CO2 Volume

6.7.1. E Flow(End of Exhaled flow)

The most important thing in deciding Exhalation time is whether sufficient exhalation has

taken place. If Exhalation time is too short, higher residual pressure called as Self PEEP (or

Auto PEEP) than PEEP pressure remains.

If the flow rate at the end of expiration is zero, then it means that lung pressure is enough

lowered down to PEEP pressure.

It means that the reference lung pressure at the end of exhalation is higher than PEEP. The

cause is short exhalation time.

In mandatory ventilation, if E_flow is not zero, Exhalation time is short and Self PEEP

exists, therefore you must lower the respiratory rate to use it.

On the other hand, if the respiratory rate is increased then you must check that E_flow is

zero after you increase the respiratory rate.

Upper figure : It is sufficient exhalation time and lung pressure is the same as PEEP and

E_flow is zero.

Lower figure : It is insufficient exhalation time and lung pressure is higher than PEEP and

E_flow is not zero.


User’s Manual

6.8. Graphics menu Screen layout can be changed in “Graphics” menu.

Item Description

Layout 1 Pressure, flow and volume graphs are displayed.

Layout 2 Among pressure-flow, flow-volume, and pressure-volume XY graph are

displayed.

Layout 3 Among pressure, flow, and volume, one wave graph is displayed with four

trend graphs.

Trend is saved at every breath.

Scrolling interval of the trend graph is adjusted by trend timing.


User’s Manual

6.9. Tools menu Insp. Hold function can be performed in “Tools” menu.

Item Description

Insp. hold Compliance, resistance, elastance and time constant of the patient

are measured with addition of one second in inspiration hold time.


User’s Manual

6.10. Events menu “Events” Menu shows all events that occur.

Item Description

Setting Events relating to changes in ventilation mode and parameter setting

are displayed

Alarm Events relating to alarm are displayed

ALL Both setting events and alarm events are displayed.


User’s Manual

6.11. System menu System menu is composed of “SETUP” menu that configures operating conditions of the

ventilator, “Date” menu that decides date and time, and “Calibration” menu that performs

various calibrations, and “Patient” menu that edit patient information.

6.11.1. SETUP

Item Range Unit STEP Description

BWF 5~15 mL/kg 1 Configure tidal volume per Kg of the patient’s

body weight(B/W).

O2 Cell ON / OFF - -

Configure the use of O2 cell, whether to enable

or disable the sensor.

ON : O2 gas is used when O2 cell is normal.

OFF : This is when there is no O2 gas, lifespan of

O2 cell has expired, or O2 cell can not be used

for a different reason. There is no influence on

supply of O2 gas.

Trend Init ON / OFF - - Initialize trend data.

BTPS*

OFF - - BTPS is turned OFF.

Manual DRY - - BTPS is turned on in the condition that

humidifier is not used.

Manual Humid - - BTPS is turned on in the condition that

humidifier is used.

Sound Vol. 10 ~ 100 % 10 Decide alarm sound volume.

ALTITUDE -100 ~ 5000 m 20 Configure altitude above sea level.

Air Temp 0 ~ 50 Celsius 1 Configure environmental temperature.

Proximal ON / OFF - -

Configure the use of proximal pressure sensor.

OFF : Proximal Pressure Sensor Off

ON : Proximal Pressure Sensor On


User’s Manual

Limb Type

Single with Ex.

Valve

/ Dual

- -

Configure Patient Limb Circuit Type.

Single Limb Circuit with Exhalation Valve/Dual

Limb Circuit

Language

English /

Spanish /

Italian/ Polish/

Turkish

- - Configure language to be displayed

Nebulizer

(Option) 10 ~ 180 minute 10 Configure usage time of nebulizer.

*BTPS is an abbreviation of "Body Temperature and Pressure Saturated with Water Vapor" and

refers to the state in which physical factors that influence volume inside body are taken into

consideration. This function compensates for volume of air supplied, considering difference

between body temperature and external temperature with altitude above sea level.

6.11.2. DATE

Item Description

Year Configure year.

Month Configure month.

Day Configure day.

Hour Configure hour.

Minute Configure minute.


User’s Manual

6.11.3. Calibration Various calibration functions are performed.

Item Range Description

Flow Zero START /OFF

This function automatically controls offset of inspiratory and expiratory flow sensor.

O2 Cell Cal.

OFF

/21%

/100%

Perform calibration of O2 Cell.

Exp. Flow Auto Cal. START /OFF

Perform adjustment of equilibrium for inspiratory flow and expiratory flow.

EtCO2 Initial START /OFF

Perform calibration of EtCO2 sensor.

Touch Cal. ON/OFF Perform calibration of Touch Screen.

Leak. Test START

/OFF Analysis of leakage and compliance is conducted.

CAUTION

When performing O2 calibration, both 21% and 100% must be carried out.

CAUTION

Before performing Exhalation Flow Auto calibration, inspiration port and expiration port

must be connected to tube.


User’s Manual

6.11.4. Patient

Item Description

BED NUMBER Designate patient’s bed number.

ID Input patient’s ID number.

IP Input IP address for external connection using LAN.

PORT Input port number for external connection using LAN.

SVC Code Configure password for IP and port input.

When user attempts to enter a number, the following keyboard appears on the screen.


User’s Manual

6.12. Alarm Setting

1/2 page shows alarms relating to ventilation. 2/2 page shows SpO2 and EtCO2 monitoring

alarms. Set appropriate alarm limit using touch and encoder.

Page Item Range Unit STEP Description

1/2

VTE 10 ~ 2500

,OFF mL 10

Configure upper / lower limits for volume

per breath.

VE MIN 0.0 ~ 50 LPM 0.1 Configure upper / lower limits for volume

per minute.

RATE 0 ~ 150 BPM 1 Configure upper / lower limits for number

of breaths per minute.

PAW 0 ~ 120,

OFF cmH2O 1

Configure upper / lower limits for

pressure.

O2 0 ~ 100,

OFF % 1

Configure upper / lower limits for oxygen

concentration.

AIR LEAK 10 ~ 500,

OFF mL 10

Configure difference between inspiratory

and expiratory volumes.


User’s Manual

Page Item Range Unit STEP Description

2/2

SpO2 51 ~ 100,

OFF % 1

Configure upper / lower limits for oxygen

saturation in blood.

PR 25 ~ 250 BPM 1 Configure upper / lower limits for heart

rate.

EtCO2 0 ~ 10 % 0.1 Configure upper / lower limits for

expiratory CO2 concentration.

iCO2 0 ~ 10 % 0.1 Configure upper / lower limits for

inspiratory CO2 concentration.

RESP 2 ~ 150 RPM 5 Configure upper / lower limits for number

of CO2 breaths per minute.


User’s Manual

6.13. Useful Hot-key

No. Item Description

1 Touch Lock Touch function is turned ON / OFF.

2 Graph Freeze When Freeze button is pushed, measurement is continued but graph display is stopped. Push the button again to unfreeze.

3 Manual Inspiration Deliver mandatory one breath.

4 Nebulizer (Option)

It is a function for a patient to breathe in by nebulizing medicine

such as nebulizing type antibiotics, etc. In general, it delivers

about 5~10ml.

It is designed to provide a certain medicine during patient’s inhalation by setting nebulizing time. But you must note that it does not operate in volume ventilation mode of below 200ml.

Touch-Key Lock

Graph Freeze

Manual Inspiration

Nebulizer


User’s Manual

6.14. Miscellaneous

No. Item Description

1 Sound Volume Indicate current alarm sound volume setting.

2 Power Status Indicate which power is being supplied.

3 I:E RATIO Ratio of I:E is displayed as a graph.

Sound Volume

I:E Ratio

Power Status


User’s Manual

7. Appendix

7.1. Setting Parameter Description

7.1.1. Trigger Function

Trigger sensitivity determines the patient’s effort during breath to induce ventilation from

ventilator.

Trigger sensitivity is configurable with flow trigger(FTRIG) or pressure trigger(PTRIG)

method. In general, flow trigger method can reduce the patient’s effort for breath.

Trigger sensitivity should be configured as high as possible without resulting in self(auto)-

triggering. Such setting increases patient-triggered ventilation and reduces auto-cycling by

the ventilator.

Pressure trigger is configurable within the range of 0.5 ~ 20 cmH2O (pressure trigger

setting is also related to PEEP setting).

Flow trigger refers to the amount of bias flow that must be inhaled by the patient to induce

new breath.

WARNING

The trigger sensitivity bar has different colors based on the setting. A light blue bar

indicates a normal setting for flow. A red bar indicates that triggering is required for flow.

The ventilator continuously delivers a gas flow during expiration, which is measured in the

expiratory channel.

1. Inspiration

Bias flow during expiration is 8 l/min.

WARNING

If the trigger sensitivity is set too high, a self triggering(auto-triggering) condition may be

reached. This condition can also be reached if there is leakage in the breathing system.

Triggering will then be initiated by the system and not by the patient. This should always

be avoided by decreasing the trigger sensitivity.


User’s Manual

7.1.2. Inspiratory Rise Time

(Time adjustment from starting point of inspiration to time of peak flow or peak pressure)

The arrival time to peak flow or peak pressure is adjustable to second or percent of

respiratory cycle at the starting point of inspiration for each breath. If rise time is high,

increased flow/pressure and it is displayed through flow and pressure waveforms

Inspiratory rise time is applicable in Pressure Control, PRVC, SIMV-Pressure Control.

Configuration of inspiratory rise time is Fast, Medium and Slow.

In general, configured rise time must be higher than default system value in order to

deliver comfortable ventilation to the patient in support mode.

7.1.3. Respiratory Rate Respiratory rate refers to the number of Respiratory or breaths per minute. The respiratory

rate is also used for calculation of tidal volume if the ventilator is configured for Minute

volume setting.

7.1.4. Apnea Time Apnea time refers to set apnea time until beginning of controlled ventilation in Spont mode.

Range of setting is 2 ~ 60sec.

7.1.5. PEEP Setting range of Positive End Expiratory Pressure (PEEP) is 0 ~ 50cmH2O. PEEP is

maintained in the alveoli and may prevent the collapse of the airways.

7.1.6. I:E Ratio/ Inspiratory Time Inspiratory time setting in MTV1000 ventilator can be done in the following two methods.

- I:E ratio (regardless of change in Respiratory)

- Setting of inspiration time (regardless of change in Respiratory)

Once inspiration time is configured in the ventilator, pause time and inspiratory rise time

are automatically changed. Change in I:E ratio according to inspiration time and pause

time is displayed in information window on the bottom right corner of user interface.

7.1.7. Volume Level Setting During initial setting for each mode of MTV1000 ventilator, volume of air supplied to the

patient can be configured by adjusting inspiratory tidal volume.


User’s Manual

7.1.8. Controlled / Supported Pressure Level In controlled pressure mode, inspiratory pressure (P. INSP) is configurable. Supplementary

pressure (P. SUPP) is configurable in supported Pressure Support, SIMV modes and

tBiLevel.

7.1.9. O2 Cencentration The setting range of O2 concentration is 21 ~ 100%.

There is also an absolute minimum limit of alarm is 18% O2 which is independent of

operating setting. If the value reaches below this point, O2 fail alarm will sound.

The screen only displays O2 concentration of 21% or higher. The alarm is delayed 60

seconds after changing the O2 concentration setting.

7.1.10. Sigh Time It is support a big volume of the patient by providing 1.5times inhalation volume per each

certain breathing in volume mode.

The maximum of volume is 1,500ml.

7.1.11. Proximal Sensor On/Off This option must be used for low flow pressure / flow supplemented patients who require

precise flow measurements and tube compensation such as premature and neonate

patients.

It is safe to use this function in supported ventilation below 200ml.

Appropriate sensor (for adults, for infants) must be used depending on the patient.

7.1.12. Mask On/Off This option can be turned On/Off in all modes except for O2 stream and HFV.

Once turned On, leakage compensation ability is increased.

7.1.13. En_Sense The EnSense means Inhalation-Trigger Enable Sensitivity. It is the function for next

inhalation trigger is triggered only when a certain volume exhalation must be taken place

proportionally to the inhalation volume.

If this function is used, it allows trigger of the patient and can restrict or prevent retrigger

phenomena and mandatory breathing can be successfully maintained.

Before the exhalation volume reach to En_Sense[%] of Vins(Supported Volume), the

trigger(Inhalation Trigger) is not enabled and system be could not go to next Inhalation

Phase by ‘En_Sense’ Function.

In case, Patient has high airway resistance and too much Ascites(Abdominal Dropsy). The

function has another solution to protect retriggering.

7.1.14. Ex_Sense


User’s Manual

The ExSense 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 expiring effort compared to the pressure detection mode in the past

and has equipment responses rapidly to the effort of the patient.

Expiration can be taken place only when it exceeds the target pressure after patient

finishes to inhalation. In this case, response speed is late and it needs patient’s effort.

The mechanic characteristic in PSV is not same in each ventilator. The Ex_Sense[%] is to

be decided by individual condition of patients.

If the patient doesn’t have enough spontaneous respiratory capacity, then inhalation must

be sufficiently taken place. Therefore Ex_Sense must be decreased.

7.1.15. Predicted Body Weight It is not the actual body weight and is based on the metabolic rate, and it is used as basic

criteria to determine Respiratory volume per minute, tidal volume, breathing rate, etc., the

trend is on the basis of height than body weight in general.

It becomes the standard of tidal volume multiplied by a BW factor(ml/Kg) and is used to

determine proper Respiratory rate per minute.


User’s Manual

7.2. Ventilation Modes

7.2.1. V-ACV(Volume Assist Control Ventilation)

Volume control mode is based on mechanical ventilation method and the ventilator

delivers configured tidal volume to the patient.

VACV mode is a mode that controls mechanical ventilation of the patient based on air

volume. It controls inspiratory and expiratory times by force

In Assist/Control mode, Assisted/Controlled Mandatory Breath is provided regardless of

period once the device detects intention of the patient to breathe. If there is no intention

to breathe, air is supplied based on Assisted/Controlled Mandatory Breath period.

Item Range Unit Step Description

B/W 10~150 kg 1 Configure patient’s body weight.

VTIDAL 50 ~ 2500 mL 5 Air volume of the patient at a time

RATE 2 ~ 60 BPM 1 Configure number of inspirations per minute.

PEEP 0 ~ 50 cmH2O 1 Configure PEEP (base pressure of patient).

O2 21 ~ 100 % 1 Configure O2 (oxygen) concentration of gas

supplied to the patient.

TI 0.2 ~ 9.9 sec 0.1 Configure inspiration time (patient).

EnSENS 10 ~ 80 % 5 Configure sensitivity with which each breath is

completed by the patient using % expiration.

TRIGGER

TYPE

Pressure/

Flow - -

Configure spontaneous ventilation detection

method as pressure or flow type.


User’s Manual

TRIGGER

Level

OFF, 0.5 ~

20

cmH2O/

LPM 0.5

Configure sensitivity for detecting spontaneous

ventilation by the patient. Choose between

pressure or flow type.

P LIMIT 5 ~ 80 cmH2O 1 Configure pressure limit supplied to the patient

during spontaneous ventilation.

SIGH

MODE

OFF/30/60/

90/120 RPB 30 1.5 times Air volume of the patient

MASK ON/OFF - - Configure mask on / off.

ACCEPT - - - Execute VACV Mode.

CANCEL - - - Move back to previous menu.

NOTE

Default value is configured in proportion to body weight of the patient.

The airway pressure is dependent on the tidal volume, inspiration time and the resistance

and compliance of the respiratory system. The set tidal volume will always be delivered.

An increase in the resistance and decrease in compliance will lead to an increased airway

pressure. To protect the patient’s lungs from excessive pressure, it is very important to

set the upper pressure limit to a suitable value.

It is possible for the patient to trigger extra breaths if they can overcome the pre-set

trigger sensitivity. It is also possible for the patient, by their own inspiratory efforts, to

receive a higher inspiratory flow and Tidal Volume during an inspiration than pre-set.

During volume control ventilation, peak flow is determined after configuration of tidal

volume and inspiratory time. Also in addition to the above two items, end flow and

plateau are items that influence peak flow.

Volume Control assures a preset tidal volume with constant flow during a preset

inspiratory time at a preset frequency.

When the preset tidal volume is delivered and after the preset pause time.

Inspiratory

Time

Inspiratory

Time


User’s Manual

I:E ratio is determined by items that influence inspiratory time and by respiratory rate.

When changing setting values of I:E ratio or items that influence inspiratory time, breath

timing bar is displayed to show changes in cycle time, inspiratory time, expiratory time

and I:E ratio.


User’s Manual

7.2.2. V-SIMV(Volume based Synchronized Intermittent Mandatory

Ventilation)

V-SIMV is a mode that controls ventilation based on volume according to spontaneous

ventilation of the patient. In other words, this mode combined control and pressure

support/ spontaneous function allows for preset mandatory breaths synchronized with

the patient’s breathing.

Spontaneous ventilation is done using configured time period or mechanical ventilation is

paralleled based on air volume if there is no spontaneous breathing.

The spontaneous/pressure supported breaths are defined by the setting for Pressure

Support.

WARNING

Mechanical ventilation is paralleled based on volume according to spontaneous ventilation

or in case of no spontaneous ventilation based on time period configured.

SIMV mode is a mode in which Mandatory Breath and Spontaneous Breath are mixed.

SIMV mode guarantees one mandatory breath per SIMV cycle. This mandatory breath is

either patient initiated mandatory (PIM or assisted mandatory) breath or ventilator

initiated mandatory (VIM or controlled mandatory) breath.

As in the figure below, each SIMV breath cycle is divided into two parts. One is

Mandatory Interval (Tm) and another is Spontaneous Interval (Ts). Once PIM breath is

delivered, mandatory interval ends and spontaneous interval (Ts) begins.

If PIM breath does not occur until mandatory interval ends, VIM breath is provided to the

patient as soon as mandatory interval ends and spontaneous interval begins.


User’s Manual

In SIMV mode, SIMV Breath Cycle is determined by the number of breaths configured. If

Respiratory Rate is configured as 12 times, SIMV Breath Cycle is 5 seconds. Mandatory

Interval is configured as smaller value between 10 seconds and 0.6 x SIMV Breath Cycle.

Mandatory Interval may be shortened depending on PIM Breath.



VTIDAL 50 ~ 2500 mL 5 Volume of the patient at a time


APNEA 2 ~ 60 sec 1 Configure time to convert to Apnea Mode if

patient shows no ventilation.


O2 21 ~ 100 % 1 Configure O2 (oxygen) concentration of gas

supplied to the patient.

TI 0.2 ~ 9.9 sec 0.1 Configure inspiration time (patient).

Trise Fast/Mediu

m/Low - -

Configure arrival time to peak flow or peak

pressure.



ExSENS 10 ~ 80 % 10 Configure spontaneous ventilation detection


TRIGGER

TYPE

PRESSURE/

FLOW - -


ventilation by the patient. Choose between


F(P)TRIG OFF, 0.5 ~

20

cmH2O/

LPM 0.5

Configure sensitivity to detect spontaneous

ventilation by the patient.

PS 0 ~ 60 cmH2O 1 Configure pressure supplied to the patient during

spontaneous ventilation.


User’s Manual




ACCEPT - - - Execute V-SIMV Mode.

CANCEL - - - Move back to the previous menu.

NOTE

Default value is configured proportional to body weight of the patient.


User’s Manual

7.2.3. P-ACV(Pressure Assist Control Ventilation)

This mode controls mechanical ventilation of the patient based on pressure.

When providing pressure control ventilation using mandatory breath in A/C mode,

configure Inspiratory Pressure.

Since pressure is maintained constant during inspiration, flow pattern is in ramp form,

and Plateau function cannot be used.

Since exhalation valve is active exhalation valve, Airway Pressure control becomes more

active and precise. Therefore, increase in pressure caused when the patient talks or

coughs during inspiration can be controlled using exhalation valve. Spontaneous

ventilation by the patient is also allowed.



PINSP 5 ~ 80 cmH2O 1 Configure pressure supplied during inspiration.

TI 0.2 ~ 9.9 sec 0.1 Configure patient’s inspiration time.

Trise Fast/Mediu

m/Slow - - Configure arrival time to peak flow or peak pressure.



O2 21 ~ 100 % 1 Configure O2 (oxygen) concentration of gas supplied to

the patient.



TRIGGER

TYPE

Pressure/

Flow - -

Configure spontaneous ventilation detection method as



User’s Manual

F(P)TRIG OFF, 0.5 ~

20

cmH2O/

LPM 0.5




ACCEPT - - - Execute PACV Mode.


The delivered volume is dependent upon the pressure above PEEP, lung compliance and

resistance in the patient tube system and airways. This means that the Tidal Volume can

vary.

As the delivered tidal volume can vary it is very important to set alarm limits for Minute

Volume to adequate levels.

When pressure control ventilation is provided by mandatory breath in assist / control

mode, inspiratory pressure is configured. Since pressure is maintained constant during

inspiration, flow pattern is shown in the form of ramp. Plateau function cannot be used.

Pressure Control assures that the preset inspiratory pressure level is maintained

constantly during the entire inspiration.

The preset pressure level is controlled by the ventilator. The resulting volume depends on

the set pressure level, inspiration time and the patient’s lung mechanical properties

during each breath.

Since exhalation valve is active exhalation valve, airway pressure control becomes more

active and precise. Accordingly, exhalation valve is used to control increase in pressure

caused by talking or coughing of the patient during inspiration. It also allows the patient

to spontaneously breathe.

If the pressure increases to the set upper pressure limit, the expiratory valve opens and

the ventilator switches to expiration.

Inspiratory

Time

Inspiratory

Time


User’s Manual

7.2.4. P-SIMV(Pressure based Synchronized Intermittent Mandatory

Ventilation)

This mode controls ventilation based on pressure according to spontaneous ventilation by

the patient. In other words, this mode combined control and pressure

support/spontaneous function allows for preset mandatory breaths synchronized with the

patient’s breathing.

Mechanical ventilation is paralleled based on air volume according to spontaneous

ventilation or in case there is no spontaneous ventilation using configured time period.

The spontaneous/pressure supported breaths are defined by the setting for Pressure

Support.

WARNING

Mechanical ventilation is paralleled based on volume according to spontaneous ventilation

or in case there is no spontaneous ventilation using configured time period.

SIMV mode is a mode in which Mandatory Breath and Spontaneous Breath are mixed.

SIMV mode guarantees one mandatory breath per SIMV cycle. This mandatory breath is

either patient initiated mandatory (PIM or assisted mandatory) breath or ventilator

initiated mandatory (VIM or controlled mandatory) breath.

As in the figure below, each SIMV breath cycle is divided into two parts. One is

Mandatory Interval ™ and another is Spontaneous Interval (Ts). After delivery of PIM

breath, Mandatory Interval ends and Spontaneous Interval (Ts) begins.

If PIM breath does not occur until the end of Mandatory Interval, VIM breath is provided

to the patient as soon as Mandatory Interval ends and Spontaneous Interval begins.


User’s Manual

In SIMV mode, SIMV Breath Cycle is determined by the configured number of breaths. If

Respiratory Rate is configured as 12 times, SIMV Breath Cycle becomes 5 seconds.

Mandatory Interval is configured as smaller value between 10 seconds and 0.6 x SIMV

Breath Cycle. Mandatory Interval may be shortened depending on PIM breath.


B/W 1~150 kg 1 Configure pressure supplied during inspiration.


TINSP 0.2 ~ 9.90 sec 0.1 Configure patient’s inspiration time.

Trise Fast/Mediu

m/Slow - -


pressure.


APNEA 2 ~ 60 sec 1 Configure time to convert to Apnea Mode if patient

shows no ventilation.


O2 21 ~ 100 % 1 Configure O2 (oxygen) concentration supplied to the

patient.

ExSENS 10 ~ 80 % 5 Configure sensitivity with which each breath is

completed by the patient using % inspiration.

TRIGGER

Type

Pressure/

Flow - -



F(P)TRIG OFF, 0.5 ~

20

cmH2O/

LPM 0.5






ACCEPT - - - Execute P-SIMV Mode.



User’s Manual

7.2.5. PRVC(Pressure Regulated Volume Control Ventilation)

Pressure Regulated Volume Control (PRVC) is a mechanical ventilation mode based on auto

pressure control. Constant volume is maintained through target volume and pressure limit

setting.

The ventilator delivers a pre-set Tidal Volume. The pressure is automatically regulated to

deliver the pre-set volume but limited to 1 cmH2O below the set pressure limit.

PRVC assures a set target minute ventilation to the patient. The target volume is based

upon settings for Tidal Volume, frequency and inspiration time.

The inspiratory pressure level is constant during each breath, but automatically adapts in

small increments breath-by-breath to match the patient’s lung mechanical properties for

target volume delivery.

Despite advantages of pressure mode, instability of not guaranteeing inspiratory volume,

caused by long-term or acute change in patient’s respiratory status or long-term change in

lung compliance, is removed.

The ventilator delivers configured tidal volume. Pressure maintained for supply of

configured tidal volume is automatically adjusted within the range of pressure limit.

The first breath of a start sequence is a volume-controlled test breath with pressure of

16cmH2O. The measured pause pressure of this breath is then used as the pressure level

for the following breath.


User’s Manual

Pressure Regulation Operation at Compliance Change of Patient


B/W 10~150 kg 1 Configure pressure supplied during inspiration.

VTIDAL 50 ~ 2500 mL 5 Air volume of the patient at a time

TINSP 0.2 ~ 9.9 sec 0.1 Configure patient’s inspiration time.

Trise Fast/Mediu

m/Slow - -


pressure.




patient.

TRIGGER

Type

Pressure/

Flow - -



F(P)TRIG OFF, 0.5 ~

20

cmH2O/

LPM 0.5






ACCEPT - - - Execute P-SIMV Mode.



User’s Manual

7.2.6. SPONT+(Spontaneous Ventilation)

This mode provides pressure support based on spontaneous ventilation.

WARNING

If spontaneous ventilation is not detected for configured time while operating in this mode,

mode is automatically converted to the mode (V-ACV or P-ACV) configured in Apnea

Backup.

WARNING

Mode returns to Spontaneous ventilation mode once the patient breathes twice by

themselves.

Once the patient’s intention for spontaneous ventilation reaches sensitivity, flow is

provided to the patient. Pressure is maintained between sensitivity setting value and

pressure level 1 cmH2O below sensitivity setting.

Once pressure becomes 1 cmH2O larger than PEEP, exhalation valve is opened to begin

expiration.

If the patient falls into apnea during SPONT mode, Apnea Alarm goes off by itself and

Apnea Ventilation (V-ACV Mode or P-ACV Mode) is automatically started. This Apnea

Ventilation is operated according to items configured by user and the Respiratory rate is

automatically changed to 15 RPM.

The mode returns to Spontaneous Mode if the patient shows two spontaneous breaths in

10 seconds.


User’s Manual


B/W 10 ~150 kg 1 Configure patient’s body weight.



patient.



ExSENS 10 ~ 80 % 5 Configure sensitivity with which each breath is

completed by the patient using % inspiration.

TRIGGER

TYPE

Pressure/

Flow - -

Configure spontaneous ventilation detection method

as pressure or flow type.

F(P)TRIG OFF, 0.5 ~

20

cmH2O/

LPM 0.5





Trise Fast/Mediu

m/Slow - -


pressure.

APNEA 2 ~ 60 sec 1 Configure time to convert to Apnea Mode if patient

shows no ventilation.

APNEA

BACKUP

TYPE

V-ACV/

P-ACV - -

Configure V-ACV or P-ACV when converting to

Apnea Mode.

APNEA


APNEA

VT 50 ~ 2500 mL 5 Volume of the patient at a time


ACCEPT - - - Execute SPONT+ Mode.



User’s Manual

7.2.7. AUTO

This mode provides an emergency quick start according to body weight.

V-ACV or P-ACV mode is selected for operation. This mode can be operated with

simplicity and stability during emergency. All settings are automatically configured and

mode can be operated as soon as body weight is entered.


B/W 10~150 kg 1 Configure patients’ body weight.

Vent Mode P-ACV/

V-ACV - - Configure operation mode.


ACCEPT - - - Execute AUTO Mode.


NOTE

If you use the Oxygen gas of low flow through the Flowmeter, the effect of oxygenation may be

negligible according to High flow.


User’s Manual

7.3. Operating Theory

Pneumatic system of the ventilator is composed of inspiratory flow control system, O2 gas

supply system, PEEP control system.

▣ Inspiratory flow control system

Blower controls inspiratory flow supplied to patient. There are three flow measurement

sensors. One is INS_DP2 for inspiratory flow measurement. Another is BLEND_DP1 for O2

gas flow measurement. The other is EXP_P4 for expiratory flow measurement.

▣ O2 gas supply system

PV valve controls O2 gas flow supplied to the tank.

▣ PEEP control system

LS1 valve controls positive end-expiratory pressure in the lungs.

Inspiratory flow control system

O2 gas supply system

PEEP control system


User’s Manual

7.4. Accessories

▣ Standard Accessories

Adult Test Lung 600ml

Or. No. PG0002_00

Info. Only Adult Model

EA 1

Power Cable

Power Cable Clamp

Or. No. AC0017_00 Or. No. AS0330_00

Info. Info.

EA 1 EA 1

Power Fuse (250V 6.3A)

High pressure O2 hose (3.5m)

Or. No. AZ0550_00 Or. No. AR0039_00

Info. Info.

EA 2 EA 1

Peep Pad Silicon

Expiration Flow Sensor

Or. No. MA0105_01 Or. No. MA0107_01

Info. Info.

EA 2 EA 1

Truss head screw M3*10mm

O2 Sensor ass'y - Installed

Or. No. AS0041_00 Or. No. MA0100_01

Info. Info.

EA 1 EA 1

User’s Manual

Air Filter

Or. No. AS0168_00 Or. No. AS0139_00

Info. Info.

EA 1 EA 1


User’s Manual

▣ Option Accessories

Ventilator Cart

Ventilator Circuit Arm

Or. No. PG0086_03 Or. No. PG0044_00

Info. Info.

EA 1 EA 1

Humidifier VHB15A

Humidifier VHB10A

Or. No. PG0032_03 Or. No. PG0032_04

Info. Info.

EA 1 EA 1

SpO2 Sensor

SpO2 Extension cable

Or. No. AC0007_00 Or. No. AC0145_00

Info. Info.

EA 1 EA 1

EtO2 Sensor

EtO2 Extension cable

Or. No. PG0022_00 Or. No. AC0124_00

Info. Info.

EA 1 EA 1

Monitor External Cable

Or. No. AC0140_00

Info.

EA 1


User’s Manual

7.5. Alarm Operation according to ventilation mode Alarm operation is determined based on ventilation mode.

MODE V Tidal

High

V Tidal

Low

V Min

High

V Min

Low

Paw

High

Paw

Low

O2

High

O2

Low

RATE

High

RATE

Low

V-ACV O O O O O O O O O O

V-SIMV O O O O O O O O O O

SPONT O X O O O X O O X X

P-ACV O O O O O O O O O O

P-SIMV O O O O O O O O O O

PRVC O O O O O O O O O O

AUTO O O O O O O O O O O


User’s Manual

7.6. SpO2 / EtCO2 Monitoring

SpO2 and EtCO2 of the patient can be measured by additionally attaching SpO2/EtCO2

modules. When the module is attached, SpO2/EtCO2 graph selection menu is added

automatically.

7.6.1. SpO2 / EtCO2 Connection Information


1

Prepare SpO2/EtCO2 Sensor

and each extension cable


User’s Manual

2

Connect SpO2/EtCO2 cable to

the socket on which

SpO2/EtCO2 label is attached on

the right side.

3

Choose SpO2/EtCO2 Waveform

4

Check the measurement

WARNING

SpO2 extension cable connector is in bright silver color. EtCO2 extension cable connector is

in black color.

Be careful not to confuse between them when connecting cables.

Sensor can be damaged by incorrect connection. Please contact customer service team if

the sensor functions improperly after mistaking between two connectors.


User’s Manual

7.6.2. SpO2 Monitoring

Oxygen saturation concentration shows the degree of saturation of hemoglobin that can

transport oxygen in the artery. That is, it displays the degree of currently transported

amount compared to oxygen transport by hemoglobin as a percentage.

WARNING

Use only SpO2 sensor certified by MEKICS. Otherwise, it may cause problems in

performance.

Incorrect methods such as tight fixation of sensor using fixing tape can harm the patient

on skin tissues.

Sensor should not be used on parts with artery catheter or vein syringe.

Do not use damaged SpO2 sensor or optical device.

Since the sensor is not waterproof, do not place in water and solvent or clean excessively.

Do not sterilize the sensor with ultraviolet ray, direct sunlight, steam or hydrogen

peroxide.

CAUTION

Do not use the sensor to patients with allergic symptoms to SpO2 sensor.

Do not use SpO2 sensor during MRI screening because there is risk of sensor burning.

Immediately remove the sensor if the patient calls for discomfort.

ATTENTION

Inaccurate values and waves can result if sensor is used incorrectly as below.

▣ When sensor not certified by MEKICS is used or sensor is used incorrectly

▣ Functional disorder in hemoglobin

▣ When sensor is excessively exposed to medical light (especially xenon light), bilirubin

light, fluorescent light, infrared heating device, or direct sunlight

▣ Excessive movement by the patient

▣ Use of high frequency electric surgical instrument or cardiac resuscitator

▣ When pulse of venous blood measured at a spot where blood pressure is measured,

pressure bandage is used, artery catheter is used, or sensor is used inside blood vessel

▣ When the patient shows symptoms of hypotension, severe blood vessel contraction,

severe anemia or hypothermia

▣ When there is arterial occlusion nearby the sensor

▣ When the patient is experiencing cardiac arrest or shock

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 measured with pressure bandage or at a spot pressured by cuffs


User’s Manual

7.6.3. EtCO2 Monitoring

EtCO2 sensor displays CO2 concentration of the patient towards the end of inspiration as

a graph.

The IRMA CO2 main stream CO2 probe is intended to be connected to other medical

devices for display of real time and derived monitoring data of CO2.

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

inspired/expired gases during anesthesia, recovery and respiratory care. It may be used

in the operating suite, intensive care unit, patient room and emergency medicine

settings for adult, pediatric and infant patients.

It shall always be used in combination with other vital signs monitoring devices and/or

professional human judgments of patient condition. The IRMA probe is intended to be

used by trained and authorized health care professionals only.

Stage Description

1 ~ 2 Initial stage of expiration in which gas inside anatomical dead space with almost no

carbon gas is discharged

2 ~ 3 Stage in which gas from pulmonary alveoli and gas inside anatomical dead space are

mixed and discharged

3 ~ 4 Stage in which gas from pulmonary alveoli is discharged

4 Partial pressure (concentration) of carbon dioxide towards the end of expiration

4 ~ 1 Inspiration

1) Setup Connection

A. Connect the IRMA analyzer interface cable to the “Gas Extension cable”.

Snap the IRMA probe on top of a new IRMA airway adapter. It will click into

place when properly seated.

1 2 3 4 1


User’s Manual

B. A green LED indicates that the IRMA probe is ready for use.

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

piece.

D. Connect the IRMA/airway adapter 15 mm female connector to the patient’s

endotracheal tube.

Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s

endotracheal tube and the IRMA probe. Placing an HME in front of the IRMA

probe protects the airway adapter from secretions and effects of water vapor

and eliminates the need of changing the adapter. It allows free positioning of

the IRMA probe as well.

Unless the IRMA probe is protected with an HME always position the IRMA

probe with the status LED pointing upwards.


User’s Manual

E. Placement of IRMA Probe

I. 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.

II. If, for whatever the reason, the IRMA probe is in direct contact with any

parts of the infant's body an insulation material shall be placed between the

IRMA probe and the body.

WARNING

▣ The IRMA probe is intended for use by authorized and trained medical personnel only.

▣ The IRMA probe must not be used with flammable anesthetic agents.

▣ Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter

can cause cross infection.

▣ Used airway adapters shall be disposed of in accordance with local regulations for

medical waste.

▣ Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6

ml dead space to the patient circuit.

▣ Do not use the IRMA Infant airway adapter with adults as this may cause excessive

flow resistance.

▣ Measurements can be affected by mobile and RF communications equipment. It should

be assured that the IRMA probe is used in the electromagnetic environment specified

in this manual.

▣ Do not place the IRMA airway adapter between the endotracheal tube and an elbow as

this may allow patient secretions to block the adapter windows and result in incorrect

operation.

▣ Do not use the IRMA airway adapter with metered dose inhalers or nebulized

medications as this may affect the light transmission of the airway adapter windows.

▣ The IRMA probe is intended only as an adjunct in patient assessment. It must be used

in conjunction with other assessments of clinical signs and symptoms.

▣ Incorrect probe zeroing will result in false gas readings.

▣ Replace the adapter if rainout/condensation occurs inside the airway adapter.

▣ Use only PHASEIN manufactured IRMA airway adapters.

▣ The IRMA probe is not intended to be in patient contact.

▣ Only use CO2 components certified by MEKICS.

CAUTION

▣ Never sterilize or immerse the IRMA probe in liquid.

▣ Do not apply tension to the probe cable.

▣ Do not operate the IRMA probe outside the specified operating temperature

environment.

▣ Federal law restricts this device to sale by or on the order of a physician. (U.S.)

▣ The IRMA Airway Adapters are non-sterile devices. Do not autoclave the adapters as

this will damage them.


User’s Manual

7.7. Test Summary 7.7.1. Guidance and manufacturer’s declaration -

electromagnetic emissions

The MTV1000 is intended for use in the electromagnetic environment specified below. The

customer or the user of the MTV1000 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11 Group 1

The MTV1000 uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in

nearby electronic equipment.

RF emissions

CISPR 11 Class A

The MTV1000 is suitable for use in all

establishments, including domestic establishments

and those directly connected to the public low-

voltage power supply network that supplies

buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

Complies

7.7.2. Guidance and manufacturer’s declaration – electromagnetic immunity

The MTV1000 is intended for use in the electromagnetic environment specified below.

The customer or the user of the MTV1000 should assure that it is used in such an

environment.

Immunity test IEC 60601

Test level

Compliance

level

Electromagnetic environment

-guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV Contact

± 8 kV air

± 6 kV Contact

± 8 kV air

Floors should be wood, concrete

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be at

least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for power

supply lines

± 1 kV for

input/output lines

± 2 kV for power

supply lines

± 1 kV for

input/output lines

Mains power quality should be

that of a typical commercial or

hospital environment.

Surge

IEC 61000-4-5

± 1 kV differential

mode

± 2 kV common

mode

± 1 kV differential

mode

± 2 kV common

mode



hospital environment.


User’s Manual

Voltage dips,

short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

< 5 % Uт

(> 95 % dip in

Uт)

for 0.5cycle

40 % Uт

(60 % dip in Uт )

for 5 cycle

70 % Uт

(30 % dip in Uт)

for 25 cycle

<5 % Uт

(< 95 % dip in

Uт )

for 5 s

< 5 % Uт

(> 95 % dip in

Uт)

for 0.5cycle

40 % Uт

(60 % dip in Uт )

for 5 cycle

70 % Uт

(30 % dip in Uт)

for 25 cycle

<5 % Uт

(< 95 % dip in

Uт )

for 5 s



hospital environment. If the user

of the MTV1000 image intensifier

requires continued operation

during power mains interruptions,

it is recommended that the

MTV1000 image intensifier be

powered from an uninterruptible

power supply.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A / m 3 A / m

Power frequency magnetic fields

should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment.

NOTE Uт is the a.c. mains voltage prior to application of the test level.

7.7.3. Guidance and manufacturer’s declaration –

electromagnetic immunity

The MTV1000 is intended for use in the electromagnetic environment specified below.

The customer or the user of the MTV1000 should assure that it is used in such an

environment.

Immunity

test

IEC 60601 test

level

Compliance

level Electromagnetic environment - guidance

Conducted

RF

IEC 61000-

4-6

Radiated RF

IEC 61000-

4-3

3 Vrms

150 kHz to 80

MHz

3 V / m

80 MHz to 2.5

GHz

3 Vrms

150 kHz to

80 MHz

3 V / m

80 MHz to

2.5 GHz

Mobile RF communications equipment should be

used no closer to any part of the MTV1000,

including cables, than the recommended

separation distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of

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

deter-mined by an electromagnetic site survey, a

80 MHz to 800 MHz

800 MHz to 2.5 GHz


User’s Manual

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

MTV1000. b Over the frequency range 150 kHz to 80MHz, field strengths should be less than [V1] V / m.


User’s Manual

7.7.4. Recommended separation distances

The MTV1000 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the MTV1000 can help Prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the MTV1000 as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

[W]

Separation distance according to frequency of transmitter

[m]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

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

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (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.


User’s Manual

7.8. Product Warranty Policy

A. This product was manufactured based on strict quality management and testing

process of our company.

B. Compensation criteria for product repair and replacement are as announced in

“Consumer Injury Compensation Rule” by the Economic Planning Board.

C. Warranty period for this product is regulated as two year since installation.

However, warranty period for LCD, battery and O2 cell is six months.

D. If the product shows defects under normal use during warranty period, our customer

service team will repair defects free of charge during warranty period.

E. Prescribed service fees are levied after repair in the following cases.

▣ Defect from natural disasters such as fire, earthquake and lightning

▣ Defect from inappropriate movement or carelessness in use of the product after

installation

▣ Defect from repair or renovation made by an individual other than service agents

designated by MEKICS

F. Preparations for repair requests

▣ If defect occurs, immediately stop the use and check details on the defect in this

manual.

▣ Before contacting our company’s customer service team for repair request, please

check model name, manufacture number, purchase date and problem.

CAUTION

If defect is caused by inappropriate handling or careless management of the product, the

manufacturer and its sales agencies are not responsible for any damages.

Contact us

For more information in detail, contact us to the following numbers and addresses.

[Manufacturer / Customer Service Team]

MEKICS Co., Ltd.

21, Sangjiseok-gil, Paju-Si, Gyeonggi-do, South Korea

TEL: +82- 07-7119-2520

FAX: 070-5052-5800

Web site: http://www.mek-ics.com

We are also receiving customer complaints through MEK ICS web site. If you experience

any discomforts or improvements to be made on the product, please feel free to contact

our company or its customer service team at any time.

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

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