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YM412i

ELECTROCARDIOGRAPH

Operators Manual
YM412i
Operators Manual

EU representative
TECNOMED 2000 S.L.
Valencia, 25-28012 Madrid Spain

Supplier
MEDIANA Co.,Ltd.
Wonju Medical Industry Park, 1650-1 Donghwa-ri,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (82) 33 742 5400 Fax: (82) 33 742 5618

Manufacturer
MEDIGATE INC.
1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea
Tel: (82) 33 747 3552 Fax: (82) 33 747 3691

YM412i Operators Manual


Part Number-Revision Number: L05222-00
Printed in Korea
Copyright 2006-2007 Mediana Co., Ltd. All rights reserved.
Notice
This document contains proprietary information that is protected by copyright. All Rights
Reserved. Reproduction, adaptation or translation without prior written permission is
prohibited, except as allowed under the copyright laws.

Warranty
The information contained in this document is subject to change without notice. Mediana
makes no warranty of any kind with regard to this material, including, but not limited to, the
implied warranties or merchantability and fitness for a particular purpose. Mediana shall not
be liable for errors contained herein or for incidental or consequential damages in connection
with the furnishing, performance, or use of this material.

Revision History
The document part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the version of the
documentation. Minor corrections and upgrades which are incorporated at reprint do not
cause the revision number to change. The document part number changes when extensive
technical changes are incorporated.
Contents
Chapter 1. Information ................................................................................................. 9
1. General Information................................................................................................ 10
2. Safety Information .................................................................................................. 11

Chapter 2. Introduction .............................................................................................. 17


1. Intended Use ........................................................................................................... 18
2. Description of control, display and symbols ....................................................... 19
3. Contacting a Mediana Service Center .................................................................. 24

Chapter 3. Putting the device .................................................................................... 25


1. List of Components ................................................................................................ 26
2. Power Cable Connection ....................................................................................... 27
3. Rechargeable Battery Operation........................................................................... 28
4. Installation and Mains Connection........................................................................ 29
5. Loading the Printer Paper...................................................................................... 29
6. External Interface Connector................................................................................. 30
7. Understanding the ECG analysis .......................................................................... 31

Chapter 4. Preparations for ECG Recording ............................................................ 33


1. Connecting the patient cable................................................................................. 34
2. Electrode Application ............................................................................................. 35
3. Position of electrodes ............................................................................................ 35

Chapter 5. Operation of YM412i ................................................................................ 37


1. Turn on the YM412i ................................................................................................. 38
2. Automatic Mode Recording ................................................................................... 39
3. Manual Mode Recording ........................................................................................ 39
4. Turn off the YM412i................................................................................................. 39
5. System Menu........................................................................................................... 40
6. Menu Configuration................................................................................................ 41
7. Operation Mode ...................................................................................................... 42
8. System Setup .......................................................................................................... 50
9. Patient Data ............................................................................................................. 61
10. File Management................................................................................................... 65
11. Maintenance .......................................................................................................... 70

Chapter 6. Cleaning and Maintenance...................................................................... 71


1. Cleaning the Cardiograph...................................................................................... 72
2. Cleaning the Patient Cable and Electrodes.......................................................... 72
3. Cleaning the Printer Head...................................................................................... 73
4. Storing Thermal Paper ........................................................................................... 73
5. Recycling and Disposal ......................................................................................... 73
6. Returning the Components ................................................................................... 74
7. Service ..................................................................................................................... 74
8. Checks before each use......................................................................................... 74
9. Periodic Visual Inspection ..................................................................................... 74
10. Device Management ............................................................................................. 74
11. Battery Maintenance............................................................................................. 77
12. Firmware Upgrade ................................................................................................ 77

Chapter 7. Troubleshooting ....................................................................................... 79


1. General .................................................................................................................... 80
2. Error Description .................................................................................................... 81

Chapter 8. Specification............................................................................................. 89
Figures
Figure 2-1. Top Panel 19
Figure 2-2. Rear Panel 19
Figure 2-3. Right Panel 19
Figure 3-1 AC Power Input 27
Figure 3-2. Recording paper insertion 30
Figure 3-3. Interface Connector 30
Figure 3-4. Automatic Mode Report.. 31
Figure 4-1. Patient Cable Connector 34
Figure 4-2. Patient Cable 34
Figure 4-3. Connecting position of the limb lead electrodes 35
Figure 4-4. Connecting position of the chest lead electrodes 36
Figure 4-5. Arranging the patient cable. 36
Figure 5-1. Copyright Screen 38
Figure 5-2. Typical Screen of ECG 39
Figure 5-3. System MENU 40
Figure 5-4. MENU Configuration 41
Figure 5-5. Operation Mode (Automatic) Menu Screen 42
Figure 5-6 Print Format 4c*2.5s 43
Figure 5-7. Print Format 2c*5s 44
Figure 5-8. Print Format 1c*10s 45
Figure 5-9. Rhythm Lead Setting Screen(Automatic Mode) 46
Figure 5-10. Median Beats Report 47
Figure 5-11. Detail Parameter Report 47
Figure 5-12. Operation Mode (Manual) Menu Screen 48
Figure 5-13. Rhythm Leads Setting Screen(Manual Mode) 49
Figure 5-14. System Setup Menu Screen 50
Figure 5-15. System Setup - Physician Setting Screen 53
Figure 5-16. System Setup - Technician Setting Screen 54
Figure 5-17. System Setup Hospital Name Setting Screen 55
Figure 5-18. System Setup Beep Setting Screen 56
Figure 5-19. System Setup Patient Data Entry Setting Screen 57
Figure 5-20. Patient Data New Patient Registration Screen 61
Figure 5-21. Patient Data Patient ID Input Screen 61
Figure 5-22. Patient Data Name Input Screen 62
Figure 5-23. Patient Data Race Input Screen 63
Figure 5-24. Patient Data Physician and Technician Selection Screen 63
Figure 5-25. Patient Data Madication Input Screen 64
Figure 5-26. File Management Menu Screen 65
Figure 5-27. File Management ECGs List. 66
Figure 5-28. File Management ECGs List Select.. 66
Figure 5-29. File Management Print the ECG Data 67
Figure 5-30. File Management Transfer Patient Data 68
Figure 5-31. File Management Delete Patient Data... 68
Figure 5-32. File Management Change Patient Data. 69
Figure 5-33. File Management Delete All ECGs.. 69
Figure 6-1. Cleaning the Printer Head 73
Figure 6-2. Maintenance Menu Screen 75
Figure 6-3. Maintenance Firmware Version 76
Figure 6-4. Firmware upgrading Screen 78

Tables
Table 2-1. Display Description 20
Table 2-2. Key Description 21
Table 2-3. Panel and Label Symbols 22
Table 3-1. List of Components 26
Table 3-2. Top panel indicator for power source 27
Table 3-3. Battery Charging Status Indications 28
Table 5-1. Lead Labels 56
Table 5-2. Default Setting Value 58
Table 7-1. Troubleshooting 80
Table 8-1. Electromagnetic Emissions (IEC60601-1-2) .. 93
Table 8-2. Electromagnetic Immunity (IEC60601-1-2) 93
Table 8-3. Electromagnetic Immunity (IEC60601-1-2) 95
Table 8-4. Recommended Separation Distances. 96
Table 8-5. Cables (IEC60601-1-2) 97
This page is intentionally left blank.
Information

Chapter 1. Information

YM412i Operators Manual 9


Information

1. General Information

y The product YM412i bears the CE marking indicating its conformity with the

provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the
essential requirements of Annex I of this directive. It is class a (MDD) equipment.
y The product is designed to comply with IEC60601 requirements. It is a protection class I,
type CF device.
y The product complies with the electromagnetic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 Electromagnetic Compatibility Medical Electrical Equipment.
y The radio-interference emitted by this device is within the limits specified in
CISPR11/EN55011, class B.
y This manual is an integral part on the device. It should always be kept near the device.
Close observance of the information given in the manual is a prerequisite for proper device
performance and correct operation and ensures patient and operator safety. Please note
that information pertinent to several chapters is given only once. Therefore, carefully
read the manual once in its entirety.
y This manual is in conformity with the device specifications and standards on safety of
electro-medical equipment valid at the time of printing. All rights are reserved for device,
circuits, techniques, and software program appearing in this manual.
y To ensure patient safety, the specified measuring accuracy, and interference-free operation,
we recommend to use only original Mediana components. The user is responsible for
application of accessories from other manufacturers.
y The warranty does not cover damage resulting from the use of unsuitable accessories and
consumables from other manufacturers.
y The safety information given in this manual is classified as follows:

Warning
Indicates a hazard. If not avoided, the hazard can result in death or serious injury.

Caution
Indicates a potential hazard. If not avoided, this hazard may result in minor personal
injury and/or product/property damage.

10 YM412i Operators Manual


Information

2. Safety Information
It is strongly recommended that the user first review this document thoroughly before operating
the system.
Warning: The electrocardiograph is intended to be used in a hospital and
hospital facilities environment by trained medical personnel.

Warning: The device is not designed for use in areas of medically used rooms
where an explosion hazard may occur. An explosion hazard may result from
the use of flammable anesthetics, skin cleansing agents and disinfectants.

Warning: Before using the device, the operator must ascertain that it is in
correct working order and operating condition. In particular, all connectors
must be checked for signs of damage. Do not use the electrocardiograph or
any accessories if damaged.

Warning: When disconnecting the device from the power line, remove the plug
from the wall outlet first, before disconnecting the cable from the device.
Otherwise there is a risk of coming in contact with line voltage by inadvertently
introducing metal parts in the sockets of the power cord.

Warning: The mains plug must be connected to an appropriate power supply


with a non-fused earthed wire. If these requirements cannot be met, operate
the device on battery power.

Warning: In order to secure electrical safety, use the equipment by inserting


the power plug of equipment into the independent wall outlet that is earthed by
all means and, in order to use multi-tap inevitably, use the one provided with
earth pin by all means.

Warning: Devices may be connected to other devices or to parts of systems


only when it has been made certain that there is no danger to the patient, the
operators, or the environment as a result. In those instances where ether is any
element of doubt concerning the safety of connected devices, the user must
contact the manufacturers concerned or other informed experts as to whether
there is any possible danger to the patient, the operator, or the environment as

YM412i Operators Manual 11


Information

a result of the proposed combination of devices.

Warning: Magnetic and electrical fields are capable of interfering with the
proper performance of the device. For this reason make sure that all external
devices operated in the vicinity of the defibrillator comply with the relevant
EMC requirements. X-ray equipment, MRI devices, radio systems etc. are
possible sources of interference as they may emit higher levels of
electromagnetic radiation. Keep the device away from these devices and verify
the device performance before use.

Warning: Dispose of the packaging material, observing the applicable waste


control regulations. Keep the packaging material out of childrens reach.

Warning: Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a maintenance worker who has the license from
Mediana.

Warning: Do not open or close the equipment on your own.

Warning: Remove all the metal accessories the patient wears and then perform
measurement.

Warning: When unsure of the setup or the placement of the external power
connection, power the device using the internal power.

Warning: Operator shall not touch patient and equipment simultaneously.

Warning: During use of equipment, avoid contact between the metal part
outside equipment and the patient.

Warning: Do not use this device along with high-frequency electrical operative
equipment, since it may damage the equipment or the patient.

12 YM412i Operators Manual


Information

Warning: The patient signal input is defibrillation-proof so it is not necessary


to remove the ECG electrodes before defibrillating the patient.
However, when using stainless steel or silver electrodes, the defibrillator
discharge current may cause complete polarization at the electrode/skin
interface. This condition may prevent ECG signal acquisition for several
minutes. With silver/silver chloride electrodes, this will not happen.
When using other electrodes, disconnect the patient cable from the device
while defibrillating the patient.

Warning: This device is intended for use under the direct supervision of a
licensed health care practitioner.

Warning: It is possible that noises beyond guaranteed from immunity


requirements of IEC60601-1-2, any radio frequency transmitting equipment and
other sources of electrical noise such as cellular phones, can result in
disruption of the device operation. Refer to the Ch.8->Manufacturers
declaration section.

Warning: To ensure patient safety, the conductive parts of the ECG electrodes
(including associated connectors) and other patient-applied parts should not
contact other conductive parts, including earth ground, at any time.

Warning: It is possible for the patient to receive a burn due to an improperly


connected electrosurgical unit. Additionally, the electrocardiograph could be
damaged or measurement errors could occur. Place the ECG cable and leads
as for as possible from the site of the electrosurgical unit and from the
electrosurgical cables. This will minimize interference and the risk of burns to
the patient.

Warning: It was designed as Class I Protection, Type CF device. Therefore, the


electrocardiograph is suitable for direct application to the cardiac.

Warning: This device will not cause abnormal operation of a patients


pacemaker or other electronic stimulator. But the device may be affected the
accuracy of the diagnosis by pacemaker or other stimulator.

YM412i Operators Manual 13


Information

Caution: Devices intended for emergency application must not be exposed to


low temperatures during storage and transport to avoid moisture condensation
at the application site. Wait until all moisture has vaporized before using the
device.

Caution: Before connecting the device to the power line, verify that the ratings
of your local power line are those indicated on the device nameplate.

Caution: Avoid humidity, high temperature, dust in the air, salt or sulfuric
material and avoid the unventilated place or the direct sunshine.

Caution: Avoid vibration or mechanical shock.

Caution: Make arrangement so that patient cable may not be twisted.

Caution: The electrodes passed the toxicity test performed by a certified


institute. However, they may cause problems with the skin when applied for
an excessive period of time. Therefore, use them for measurement only.

Caution: After operation has finished, in order to prevent malfunction, clean


the equipment and accessories.

Caution: When cleaning the equipment, wipe it with sponge or something like
that wetted with soapy water and never use the detergent using alcohol,
ammonia or acetone as main ingredient.

Caution: When cleaning the equipment, pay special attention so that cleaning
liquid and so on may not soak into the inside of equipment.

Caution: Handle the electrode with care so that its inside surface is not
scratched.

14 YM412i Operators Manual


Information

Caution: Service shall be performed by the designated professional technician


by all means.

YM412i Operators Manual 15


Information

This page is intentionally left blank.

16 YM412i Operators Manual


Introduction

Chapter 2. Introduction

YM412i Operators Manual 17


Introduction

Caution: Medical technical equipment such as the YM412i must only be used
by qualified and trained personnel.

1. Intended Use
The intended use of the cardiograph is to acquire multi-channel ECG signals from adult
patients from body surface ECG electrodes and to record, display, analyze, and store these
ECG signals for review by the user. The cardiograph is to be used in healthcare facilities by
trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms
that provide measurements, data presentations, graphical presentations, and interpretations
for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician
on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the
patient, the results of the physical examination, the ECG tracings, and other clinical findings.
A qualified physician is asked to overread and validate (or change) the computer-generated
ECG interpretation.

18 YM412i Operators Manual


Introduction

2. Description of control, display and symbols

Thermal
Printer Graphic
LCD

Keypad

Figure 2-1. Top Panel

Figure 2-2. Rear Panel

Figure 2-3. Right Panel

YM412i Operators Manual 19


Introduction

Table 2-1. Display Description


Graphic LCD

1 2 3 4 5 6 7

10mm/mV 25mm/s 0.5Hz 60Hz 150Hz off Automatic

I V1

II V2

III V3

aVR V4

aVL V5

aVF V6

06/02/28 PM11:43 II 4c x 2.5s HR 60

8 9 10 11

No. Item Description

1 Gain Gain indication of ECG signal


2 Speed Writer speed indication of ECG signal
3 High Pass Filter High pass filter
4 AC Line Filter Elimination of Ac line interference
5 Low Pass Filter Low pass filter or
Elimination of muscle artifact (only automatic
6 Muscle Filter
mode)
7 Measurement Mode Indication of measurement mode
8 Date, Time Date and Time indication
- Manual Mode: Lead combination indication
9 Lead
- Auto Mode: Rhythm Lead indication
10 Report Format Indication of report format
11 Heart Rate Indication of heart rate

20 YM412i Operators Manual


Introduction

Table 2-2. Key Description


Keypad

Key Description

1 SENS Number 1 or Selects the gain(5, 10, 20mm/mV)(SENS)


2 SPEED Number 2 or Selects the writer speed 5, 10, 25, 50mm/s(SPEED)
3 FILTER Number 3 or Selects the filter(FILTER)
Number 4 or Graphic LCD displays the configuration(3-6-12Ch)
4 G MODE
menu(G MODE)
5 C MODE Number 5 or Selects the ECG leads display(C MODE)
6 COPY Number 6 or Printout of ECG copies(COPY)
7 SAVE Number 7 or Manual save of ECG
8 Number 8
9 FILE Number 9 or ECG data list
0 PATIENT Number 0 or Enables entry of patient data(PATIENT)
ENTER RUN Confirms entered data(ENTER) or Printout of reports(RUN)

MENU Enables entry of MENU(MENU) or Cursor up key()
(Up)
ESC DEL Escape key(ESC) or Delete(DEL)

AUTO Selects the Automatic Mode(AUTO) or Cursor left shift key()
(Left)

MANUAL Selects the Manual Mode(MANUAL) or Cursor down key()
(Down)

Stops the device in the Manual Mode(STOP) or Cursor right shift


STOP
(Right) key()

YM412i Operators Manual 21


Introduction

Table 2-3. Panel and Label Symbols


Symbols Description

AC IN indicator(Green LED)

Power On indicator(Green LED)

Battery charging status indicator(Yellow LED)

POWER Power On/Off Button

Consult accompanying documents

Type CF - Defibrillator proof

AC IN AC power input Connector(AC100-240V, 50/60Hz)

Equipotential terminal

LAN Connector

USB interface Connector

22 YM412i Operators Manual


Introduction

RS-232C RS-232 interface connector

CE mark

EU representative

Manufacturer

Date of manufacture

Crossed-out wheeled bin

Dust and water resistance

REF Reference number

SN Serial number

Environmental shipping/storage altitude limitations

Environmental shipping/storage altitude limitations

YM412i Operators Manual 23


Introduction

Environmental shipping/storage temperature limitations

Fragile-Handle with care

Keep dry.

This way up

Consult accompanying documents

3. Contacting a Mediana Service Center


The Mediana Service Center can assist with product troubleshooting and provide
technical expertise to help with any issue with the YM412i cardiograph or any of its
accessories.

TEL +82-33-742-5400
FAX +82-33-742-5618

24 YM412i Operators Manual


Putting the device

Chapter 3. Putting the device

YM412i Operators Manual 25


Putting the device

1. List of Components

Table 3-1. List of Components

YM412i Main 1EA Clamp Electrodes 1Pack Chest Electrodes 1Pack

Patient Cable 1EA Power Cable 1EA Thermal Paper 1Pack

Operators manual 1EA

Serial Cable 1EA Ground Cable 1EA

NOTE: The above pictures vary from the original in some points.

26 YM412i Operators Manual


Putting the device

2. Power Cable Connection


Warning: Do not use multiple portable socket outlets to connect the device to
the power line.

Caution: If in doubt the integrity of the AC power source, the device must be
operated from its internal battery.

YM412i can be operated with normal power source. Input voltage range of power is 100-
240VAC, and input frequency is 50/60Hz. Power cord connector is situated at the rear side.

Figure 3-1 AC Power Input


1) Connect the female connector end of the AC power cord to the devices rear panel mains
connector.
2) Plug the male connector end of the AC power cord into a properly grounded mains outlet.
3) If necessary, connect grounding wire. Connect the grounding wire connector to the
equipotential terminal on the rear panel. Now attach the clip end of the grounding wire to the
medical equipment grounding terminal on the wall.
Table 3-2 Top panel indicator for power source
Power Connections Top panel Indicator illuminate
(Green LED ON)
AC IN
Power OFF (OFF)
Fully charged battery
(Yellow LED ON)
(Green LED ON)
AC IN
Power ON (Green LED ON)
Fully charged battery
(Yellow LED ON)
(OFF)
AC OUT
Power ON (Green LED ON)
Battery operation
(OFF)

YM412i Operators Manual 27


Putting the device

NOTE: Even if the device is not turned on, the AC IN indicator ( ) is lit when the
AC power cord is connected into a mains outlet.

NOTE: If AC indicator is not lit, check the power cord, the AC power inlet,
the power / mains outlet.

3. Rechargeable Battery Operation


Caution: Recharging battery is strongly recommended when it has not been
fully recharged for 2 or more months.

Caution: When the voltage of the battery is very low, it is a possibility of not
operating.

NOTE: It is recommended that the device remain connected to AC power source when
not in use. This will ensure a fully charged battery whenever it is needed.

1) Operating on battery power


The equipment is internally provided with Ni-MH charging battery so as to be operated without
supply of AC power. The charging battery can be automatically charged by inputting AC power;
yellow LED on flashes while charging is under progress, and then the flashing stops when
charging is completed.

2) Battery status
If battery power is deficient, the battery capacity short warning Battery Low is displayed on
the screen. A warning message Battery Low appears and beep sounds before the device
shuts off. After that, the device automatically shut down. When warning message Battery
Low appears, all keys are not operation. Connect the device to an AC power source to avid
any loss of trends or setting.

Table 3-3 Battery Charging Status Indications


Battery conditions Battery charging status indicator( )
Full charged On
Charging Flashing
Battery Operation Off

28 YM412i Operators Manual


Putting the device

NOTE: Even if the device is turned off, Battery indicator ( ) flashes while the
battery is recharged.

NOTE: A fully charge of a depleted battery takes approximately 6 hours while the
device is turned on/off.

Warning: Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a qualified service engineer.

Caution: For environmental protection, please discard the worn accessories at


the designated area in accordance with proper protocol.

Caution: It is recommended to use the equipment at the environment where AC


rated power is provided, and it is required to use the charging battery power
source during emergency situation or during inevitable movement. On the
other hand, when using battery, charge it for at least 6 hours and then use it.

4. Installation and Mains Connection


Make arrangement so that patient cable may not be twisted. For interference-free operation,
it is important that the patient cable and the power cord do not parallel.
1) Using the power cord, connect the device to the power line (Figure2-2). Use only the original

power cord or an equivalent cable. Indicator will illuminate.

2) Check the paper supply. If it is necessary to insert a new paper, refer to 5. Loading the
Printer Paper for instructions.

5. Loading the Printer Paper


Use printer papers provided by Mediana or certified by a public institute.

As shown in the Figure 3-2 below, open printer cover, insert shaft into the thermal paper, and
then put it in the equipment.

As shown in the Figure 3-2, make the paper come out upside and then close the printer cover.

YM412i Operators Manual 29


Putting the device

Figure 3-2. Recording paper insertion

NOTE: When using the separately purchased printer paper, manufacturer or its agent
does not take responsibility for bad printing or product damage that occurs.

6. External Interface Connector


3) LAN Connector

2) USB Connector
1) RS-232 Connector

Figure 3-3. Interface Connector

1) RS-232 Connector
This is a communication device that transmits the measurement data to the PC. The
transmitted data may be viewed by using separate software. The PC in operation must use the
certified product, and Mediana is not responsible for problems that occur when using non-
certified products.

30 YM412i Operators Manual


Putting the device

2) USB Connector
Use it only when upgrading firmware through USB memory stick. For firmware upgrade,
refer to Chapter 6. Cleaning and Maintenance.

3) LAN(RJ45) Connector
Function Reserve.

7. Understanding the ECG analysis


The analysis process begins with the simultaneous acquisition of the ECGs 12 conventional
leads. It then proceeds through four steps before producing the interpreted ECG report. These
steps are:
1) Quality Monitor - examines the technical quality of each ECG lead.
2) Pattern Recognition - locates and identifies the various waveform components.
3) Measurement - measures each component of the waveform and performs basic rhythm
analysis, producing a comprehensive set of measurements.
4) Interpretation- uses the extended measurements, with information about the patient such
as age and sex, to select those interpretive statements from the criteria program which
summarize the findings for the ECG.
5) Automatic Mode Report

Figure 3-4. Automatic Mode Report


ECG waveform: 12Leads ECG waveform-I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,

YM412i Operators Manual 31


Putting the device

V5, V6
Calibration Pulse: This is the rectangular waveform shown in line of ECG trace. It
shows how much the cardiograph deflected the trace in response to a 1 mV
calibration pulse applied to the acquisition circuitry.
Rhythm Lead: The interpretive cardiograph can print ten seconds of one lead at the
bottom of the Auto report. This additional trace is a rhythm lead. Rhythm lead shows
the same ten seconds of ECG data as in the auto interpretive report.
Patient Information: This information is entered by the technician when the ECG is
taken.
System Information: Information about the settings at which the ECG was taken is
listed at the right of the Auto report.
Detection Result: This block gives standard interval and duration measurements in
milliseconds, and limb lead axis measurements in degrees. These are
representative values for the dominant beat pattern in the ECG.
Diagnosis Result: The measurements and interpretation can help the physician
save time when overreading reports.

32 YM412i Operators Manual


Preparations for ECG Recording

Chapter 4. Preparations for ECG Recording

YM412i Operators Manual 33


Preparations for ECG Recording

1. Connecting the patient cable


Use the 10-lead patient cable for acquisition of the standard ECG leads. Connect the patient
cable to Figure 4-2.

Figure 4-1. Patient Cable Connector

Figure 4-2. Patient Cable

Warning: For reasons of patient safety, use only the original Mediana patient
cable. Before connecting the cable to the device, check it for signs of
mechanical damage. Do not use a damaged cable.

34 YM412i Operators Manual


Preparations for ECG Recording

2. Electrode Application
Careful application of the electrodes is the key to an interference-free ECG.
For quick, reliable and trouble-free application of electrodes, we recommend using the original
Mediana electrode.

3. Position of electrodes
Lay the patient on the bed in a relaxed state and get rid of any tension on the muscle. Clean
the area of contact with a moist tissue to allow stable contact between the skin and the
electrode. Shave the contact area if there is excess body hair, and precisely attach the
electrode. Incorrect attachment of the electrode affects the accuracy of the diagnosis;
therefore, it is critical to attach the electrode at the correct place. If the electrocardiogram is
unstable, check the status of the electrode, power supply (avoid using more than one
equipment per outlet), connection, et cetera.

Limb Lead Chest Lead

AHA

IEC

Figure 4-3. Connecting position of the limb lead electrodes

YM412i Operators Manual 35


Preparations for ECG Recording

Figure 4-4. Connecting position of the chest lead electrodes


V1: Right side of the sternum in the 4th intercostals space
V2: Left side of the sternum in the 4th intercostals space
V3: Midway between V2 and V4
V4: Left midclavicular line in the 5th intercostals space
V5: Anterior axillary line at the same level as V4
V6: Left midaxillary line at the same level as V4

Correct Incorrect
Figure 4-5. Arranging the patient cable

Caution: When cleaning the electrode, it is better to wipe it with water or


something like that and it is recommended not to use benzene or something
like that because it can cause deformation to rubber or plastic. In addition,
because metal part is treated with silver chloride, avoid severe wiping with
rough cloth or something like that.

36 YM412i Operators Manual


Operation of YM412i

Chapter 5. Operation of YM412i

YM412i Operators Manual 37


Operation of YM412i

1. Turn on the YM412i


1) Turn on the YM412i by pressing POWER button for over 1second. Confirm that the Power
on indicator ( ) on the top of the top panel is lit.

2) After completed successfully the booting, a copyright screen appears. The copyright screen
displays the company log and the version of system.

YM412i-V0.01

Figure 5-1. Copyright Screen

3) After the copyright screen disappears, the YM412i initiates operation.

38 YM412i Operators Manual


Operation of YM412i

4) When the device detects valid signals, it displays real-time waveforms similar to Figure 5-2.

Figure 5-2. Typical Screen of ECG

2. Automatic Mode Recording

1) After turning on the device, press to select the automatic mode.


2) In automatic mode, 12 leads of ECG are acquired simultaneously for a period of 10 seconds.

3) Press key, the device prints the most recent 10 seconds of ECG data and analyzes it.

3. Manual Mode Recording

1) After turning on the device, press to select the manual mode.

2) Press key, the device prints continuous ECG data.

3) Press key, the recording is stopped.

4. Turn off the YM412i


Turn off the YM412i by pressing POWER button for over 2 seconds.

YM412i Operators Manual 39


Operation of YM412i

5. System Menu

Press MENU key in order to enter the menu. Pressing MENU key shows detailed
menus as follows.

Configuration

Operation Mode [Auto] [Manual]


System Setup
Patient Data
File Management
Maintenance

Figure 5-3. System MENU

z Shift of menu item: Navigate using (Up), (Down), (Left),

(Right) keys. Shadow box ( ) highlights the menu item to be selected.

z Selection of menu item: Move shadow box ( ) to the desired item, and press

(Enter) to select the item.

z Changing the setting: Highlight the desired setting in the same manner as selection

of menu item, and press (Enter) to change the setting.

40 YM412i Operators Manual


Configuration

Operation Mode [Auto] [Manual]


System Setup
Patient Data
File Management
Maintenance
6. Menu Configuration

Operation Mode Operation Mode File


System Setup Patient Data Maintenance
[Automatic] [Manual] Management
Gain New Patient
Physician
Speed Patient ID
Technician
Report Format Last Name
Hospital Name
No.of Copy First Name Copy Demo Mode
Gain Cart No.
Rhythm leads Date of Birth Manual Save LCD Test
Speed Location No.
Interpretation Height ECG data list Printer Test
Rhythm Leads Date Format
Print Interpretation Weight Delete All ECGs Firmware Ver.
Date
Print Median Beat Gender
Time Format
Operation of YM412i

Print Detail Result Race


Time (hh:mm)
Muscle Filter Pacemaker
Units

YM412i Operators Manual


Beep Physician

Figure 5-4. MENU Configuration


Lead Labels Technician
LCD Light Off Room No.
Communication Medication1
Patient Data Entry Medication2
High cut-off Filter Comments
AC Line Filter on-off
AC Line Filter
Low cut-off Filter
Auto Save
Default Setting
Print Setup Menu list

41
Operation of YM412i

7. Operation Mode
1) Operation Mode (Automatic)
When set as Automatic Mode, the device prints the electrocardiogram over the past 10
seconds. The form the printed wave and other items to be printed on the report can be
selected at the follow sub-menu settings window.

Operation Mode(Automatic)

Gain 5mm/mV 10mm/mV 20mm/mV


Speed 5mm/s 10mm/s 25mm/s 50mm/s
Report Format 4c*2.5s 2c*5s 1c*10s
No. of Copy 1
Rhythm Leads II Others
Interpretation Yes No
Print Interpretation Yes No
Print Median Beat Yes No
Print Detail Result Yes
Muscle Filter On Off

Figure 5-5. Operation Mode (Automatic) Menu Screen

Gain: Choose between three different sizes of electrocardiogram wave (5mm/mV,

10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired size, and

press (Enter) to select.

Tip) Gain of cardiogram waveform is changed with (SENS) key by selecting 5/


, 10/ and 20/.

Speed: Choose between four different output speeds (5mm/s, 10mm/s, 25mm/s,

and 50mm/s). Move shadow box ( ) to the desired speed, and press (Enter) to

select.

Tip) Output speed of cardiogram waveform is changed with (SPEED) key by


selecting 5/sec, 10/sec, 25/sec and 50/sec.

42 YM412i Operators Manual


Operation of YM412i

Report Format: Report format can change by selecting 4c*2.5s, 2c*5s, 1c*10s.

Figure 5-6 Print Format 4c*2.5s

YM412i Operators Manual 43


Operation of YM412i

Figure 5-7. Print Format 2c*5s

44 YM412i Operators Manual


Operation of YM412i

Figure5-8. Print Format 1c*10s

YM412i Operators Manual 45


Operation of YM412i

No. of Copy: COPY key is used to output again the cardiogram data measured and
outputted just before. The copy can support up to 9 sheets.

Rhythm Lead: This is printed at the bottom of the report, serving as a standard to
other channels. There are 12 possible leads for use (I, II, III, aVR, aVL, aVF, V1, V2,
V3, V4, V5, V6). The default lead is Lead II. If other leads are needed, move shadow

box ( ) to Others, and press (Enter) to bring the sub-menu like below.

Choose the desired lead.

Figure 5-9. Rhythm Lead Setting Screen (Automatic Mode)

Interpretation: Choose whether to diagnose the electrocardiogram or not. If set to


YES, diagnosis will process. If set to NO, there will be no diagnosis.

Print Interpretation: Choose whether to print the diagnosis or not. If


Interpretation is set as YES, and this item is set as YES as well, the diagnosis will be
printed. If NO, the diagnosis will not be printed. If Interpretation is set as NO, this
item is automatically set as NO.

46 YM412i Operators Manual


Operation of YM412i

Print Median Beat: Choose whether to print the median value of the
electrocardiogram wave (the value of the middle of the wave) or not. If set as YES, the
median beat will be printed. If set as NO, the median beat will not be printed.

Figure 5-10. Median Beats Report

Print Detail Result: Choose whether to print the detail result or not. If set as YES,
the detail result (average value of the selected rhythm lead) will be printed. If set as
NO, the detail result will not be printed.

Figure 5-11. Detail Parameter Report

Muscle Filter: Choose whether to apply the muscle filter or not. If set to On,
muscle filter will be applied. If set to off, muscle filter will not be applied.

YM412i Operators Manual 47


Operation of YM412i

2) Operation Mode (Manual)


Caution: Do not print more than 30min in the manual mode. It can result in
break down or reduction of life time of the device.
When set to manual mode, electrocardiogram from 3 channels is outputted consecutively,
allowing longer observation of the electrocardiogram signal, and the output can be stopped

STOP


using (stop) key. The following options, including the form of the electrocardiogram

wave and the items to be printed on the report, can be set at the sub-menu setting window.

Figure 5-12. Operation Mode (Manual) Menu Screen


Gain: Choose between three different sizes of electrocardiogram wave (5mm/mV,

10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired size, and press

(Enter) to select.

Tip) Gain of cardiogram waveform is changed with (SENS) key by selecting 5/


, 10/ and 20/.

Speed: Choose between four different output speeds (5mm/s, 10mm/s, 25mm/s, and

50mm/s). Move shadow box ( ) to the desired speed, and press (Enter) to select.

Tip) Output speed of cardiogram waveform is changed with (SPEED) key by


selecting 5/sec, 10/sec, 25/sec and 50/sec.

48 YM412i Operators Manual


Operation of YM412i

Rhythm Leads: The outputted waves leads can be selected. 4 different combination
sets are available ([I, II, III], [aVR, aVL, aVF], [V1, V2, V3], and [V4, V5, V6]). In addition, 1
combination sets, customized by the user, can be customized and used. In order to

customize the combination set, move shadow box ( ) to C:[ , , ], and press

(Enter) to bring the sub-menu like below. Choose the desired lead.

Operation Mode(Manual)

Gain 5mm/mV 10mm/mV 20mm/mV


Speed 5mm/s 10mm/s 25mm/s 50mm/s
Rhythm Leads I, II, III Others

1: [I, II, III]


2: [aVR, aVL, aVF]
3: [V1, V2, V3]
4: [V4, V5, V6]
C: [ , , ]

Figure 5-13. Rhythm Leads Setting Screen(Manual Mode)

Tip) To cycle between different combinational sets, press (CMODE). Each press of

(CMODE) will change the set from 1 to C. If not using the customized
combination set, the cycle will be from 1 to 4.

YM412i Operators Manual 49


Operation of YM412i

8. System Setup

Figure 5-14. System Setup Menu Screen

50 YM412i Operators Manual


Operation of YM412i

Text Input Tip


Example
<Patient Data>
Patient Last Name: HAN

Move shadow box( ) to the Last Name, and press (ENTER) key to show
the text input window.

Patient Data

Patient ID 0000000000
Last Name HAN
First Name SANG HUN
Race Unknown
Date of Birth 25.07.1973 (dd.mm.yyyy)
Height 000 cm
Weight 000 kg
Gender Male Female
Pacemaker Yes No
Physician No Others
Technician No Others
Location No. 1
Medication 1 1 2 3 No 5 6 7 Others
4 8 9 0
Medication 2 A B C DNo E F G Others
H I J
Text Input
Window

10 letters are shown in alphabetical order. The (up) key and the (down)
key will show the next 10 alphabets and the previous 10 alphabets, respectively.

If trying to type H, press number 8 on the keypad to display H on the third line of the text-
input window. The next letter A can be typed by pressing number 1.

YM412i Operators Manual 51


Operation of YM412i

The last letter N can typed by pressing down( ) and number 4.

If complete the text input, finish by pressing Enter( ).

52 YM412i Operators Manual


Operation of YM412i

1) Physician
Edit Up to 10 physicians may be recorded. If other physicians are edited, move shadow box

( ) to Edit, and press (Enter) to bring the sub-menu like below.

After select the desired Edit No., press (Enter). Then a text box that inputs name of the
physician shows, and the desired text can be typed. Refer to the text input tip when inputting
the name of the physician.

Figure 5-15. System Setup - Physician Setting Screen

Delete If delete the physician, after select the desired Delete No., press (Enter).

YM412i Operators Manual 53


Operation of YM412i

2) Technician
Edit Up to 10 physicians may be recorded. If other technicians are edited, move shadow box

( ) to Edit, and press (Enter) to bring the sub-menu like below.

After select the desired Edit No., press (Enter). Then a text box that inputs name of the
technician shows, and the desired text can be typed. Refer to the text input tip when inputting
the name of the technician.

Figure 5-16. System Setup - Technician Setting Screen

Delete If delete the technician, after select the desired Delete No., press (Enter).

54 YM412i Operators Manual


Operation of YM412i

3) Hospital Name

When you move shadow box ( ) to Hospital Name and press (Enter), a text box that

inputs name of the hospital shows, and the desired text can be typed. Refer to the text input tip
when inputting the name of the hospital.

System Setup
Physician [ List Edit ]
Technician [ List Edit ]
Hospital Name [ ]
Cart No. 1
Location No. 1
Date Format dd/mm/yy mm/dd/yy
Date 00.00.00
Time Format 12 24
Time(hh:mm) 00:00 AM PM
Units cm, kg in, lb
Lead Fail Beep Yes No
HR Beep Yes No
Lead Labels IEC AAMI
LCD1Light Off
2 3 4 5
[ 00 ] (min)
6 7 8 9 0
Patient Data EntryC
A B D E F G H
Displayed Patient Data Entry
I J
medigate hospital

Figure 5-17. System Setup Hospital Name Setting Screen

4) Cart No.
When using multiple devices from multiple carts, each device can be assigned a cart number.

5) Location No.
When using multiple devices from multiple locations, each device can be assigned a location
number.

6) Date Format
Choose between two different formats of date (dd/mm/yy (Day/Month/Year) or mm/dd/yy
(Month/Day/Year).

7) Date
Set the current date.

8) Time Format
Choose between two different formats of time (12 hour format or 24 hour format)

YM412i Operators Manual 55


Operation of YM412i

9) Time(hh:mm)
Set the current time (adjusted according to the selected time format)

10) Units
Choose between two different unit system (cm, kg or in, lb) when displaying the patients
height and weight.

11) Beep
Set the alarm that heart rate beep, key press beep and warning beep. Move shadow box

( ) to On and press (Enter), a sub-window that setup of each beep shows, and the

desired beep can be selected.

Figure 5-18. System Setup Beep Setting Screen

12) Lead Labels


Choose between two different lead labels, IEC (European) or AAMI (American).

Table 5-1 Lead Labels

Limb lead Chest lead


IEC R L N F C1 C2 C3 C4 C5 C6
AAMI RA LA RL LL V1 V2 V3 V4 V5 V6

56 YM412i Operators Manual


Operation of YM412i

13) LCD light off


Set the LCD light time. The LDC light time can selecting of 1, 3, 5, 10, 15, 20, 30, 40, 60,
90min. If set Off, LCD light is not off.

14) Communication
The device provides external connectors (RS-232, LAN) on the rear panel to support
communication with PC.

15) Patient Data Entry


Choose whether to input the patient data or not when registering the patient.

Patient Data Entry

Height Yes No
Weight Yes No
Race Yes No
Gender Yes No
Pacemaker Yes No
Physician Yes No
Technician Yes No
Room No. Yes No
Medication1 Yes No
Medication2 Yes No
Patient ID Check Yes No

Figure 5-19. System Setup Patient Data Entry Setting Screen

16) High cut-off Filter


The low pass filter removes the high-frequency noise from the electrocardiogram. Four modes
are available (40Hz, 100Hz, 150Hz, or off). The filter setting is displayed at the printed report
and at the top of the LCD.

17) AC Line Filter ON/OFF


The notch filter, used to remove noise from power source, can be turned on or off

18) AC Line Filter


The notch filter, used to remove noise from power source, can be set as 50Hz or 60Hz. The
filter setting is displayed at the printed report and at the top of the LCD.

YM412i Operators Manual 57


Operation of YM412i

19) Low cut-off Filter


The high pass filter removes the baseline changes of the low-frequency signal. Two modes are
available (0.5Hz or 0.05Hz). The filter setting is displayed at the printed report and at the top of
the LCD.

Tip) Press (FILTER) key to switch between the modes. When pressing the key, a
sub-window (shown below) is displayed. Use the directional button to move the shadow box

( ) to the desired filter, and press (Enter) to apply the selected filter. Press ESC to

exit the sub-window.


Automatic Mode

Manual Mode

20) Auto Save


Choose whether to conduct auto-save or not.

21) Default Setting


Initialize all the settings value, and return all settings to default. Choose YES to initialize the
settings value.

Table 5-2. Default Setting Value


Operation mode(auto) Gain 10mm/mV
Speed 25mm/s
Report Format 4c X 2.5s
No. of Copy 1 (range 1~9)
Rhythm leads II
Interpretation Yes

58 YM412i Operators Manual


Operation of YM412i

Print Interpretation Yes


Print Median Beat No
Print Detail Result No
Muscle Filter Off
Gain 10mm/mV
Operation mode(manual) Speed 25mm/s
Rhythm Leads I, II, III
Physician list Empty
Technician list Empty
Hospital Name Empty
Cart No. 001
Room No. 001
Date Format dd/mm/yy
Date 00/00/00
Time Format 12
Time(hh:mm) 12:00 AM
Units cm, kg
System Setup
Beep All beep off
Lead Labels IEC
LCD light off 20 min
Communication RS-232
High cut-off filter 100Hz
AC line filter on-off On
AC line filter 50Hz or 60Hz
Low cut-off filter 0.05Hz
Auto Save No
Default Setting No
Patient Data Entry Height Yes
Weight Yes
Gender Yes
Race Yes
Pacemaker Yes
Physician Yes
Technician Yes

YM412i Operators Manual 59


Operation of YM412i

Location No. Yes


Medication1 Yes
Medication2 Yes
Pat. ID Check No
New Patient No
Patient ID Empty
Last Name Empty
First Name Empty
Date of Birth 00.00.0000
Height 000
Weight 000
Gender Male
Race unknown
Patient Data
Pacemaker No
Physician Non-select
Technician Non-select
Room No. 00000
Medication1 No
Medication2 No
Comments1 Empty
Comments2 Empty
Comments3 Empty
File Management ECG data list Delete All Data
Maintenance Demo Mode Off

22) Print Setup Menu List


Print the current setting values.

60 YM412i Operators Manual


Operation of YM412i

9. Patient Data
Input the data of the patient. The following data can be input.

Tip) Press the (Patient) key to directly access the patient data input window (without
going through the menu).
1) New Patient
When registering a new patient, press YES. When editing the data of the existing patient,
press NO.

Patient Data
New Patient Yes No
Patient ID 0000000000
Last Name [ ]
First Name [ ]
Date of Birth 00.00.0000 (dd.mm.yyyy)
Height 000 cm
Weight 000 kg
Gender Male Female
Race unknown
Pacemaker Yes No
Physician No Others
Technician No Others
Room No. 00000
Medication 1 No Others
Medication 2 No Others
Comments [1]
[2]
[3]

Figure 5-20. Patient Data New Patient Registration Screen


2) Patient ID

The ID of a patient consists of 10-digit number. Move shadow box ( ) to the Patient ID

and press (Enter) to input the Patient ID.

Figure 5-21. Patient Data Patient ID Input Screen

YM412i Operators Manual 61


Operation of YM412i

3) Last Name, First Name

Input the name of the patient. Move shadow box ( ) to the name and press (Enter) to

input the name. Refer to the text input tip for inputting the name.

Figure 5-22. Patient Data Name Input Screen

4) Date of Birth
Input the birthday of the patient. When inputting the day or the month, the number being
inputted cannot exceed 31 or 12, respectively.

5) Height, Weight
Input the height and the weight of the patient. The unit of the data can be selected at the
System Setup. Height and weight can be entered to the extent of 400cm, 400kg.

6) Gender
Input the gender of the patient.

62 YM412i Operators Manual


Operation of YM412i

7) Race
Choose and input the patients race. Press (Enter) at Race to list the selectable race. Select
the appropriate race and press (Enter) to input the data.

Figure 5-23. Patient Data Race Input Screen

8) Pacemaker
Input whether the patient uses a pacemaker with this device.

9) Physician, Technician
Choose whether to input the related physicians and/or technicians. Press (Enter) at Others. A
sub-window will be displayed, selecting the physicians and/or technicians. Refer to the text
input tip to input the names.

Figure 5-24. Patient Data Physician and Technician Selection Screen

YM412i Operators Manual 63


Operation of YM412i

10) Room No.


Input the room number about the patient.

11) Madication 1, 2
Input the prescribed medications for the patient. Refer to the text input tip to input the words.

Figure 5-25. Patient Data Madication Input Screen

12) Comments [1], [2], [3]


Input the physicians comments about the patient.

64 YM412i Operators Manual


Operation of YM412i

10. File Management

Figure 5-26. File Management Menu Screen

1) Copy
Use when printing the ECG data measured up to the time of printing (as is or as adjusted).

Tip) Use (Copy) key to print directly (without going through Menu->File
Management->Copy)

NOTE: After the ECG report print at auto mode, the measured ECG data cannot copy
when the stored ECG data to file management (memory) print.

2) Manual Save
Use when manual saving the ECG data measured up to the time of measuring under non-
setting auto save mode.

Tip) Use (Save) key to save directly (without going through Menu->File
Management->Manual Save)

NOTE: After the ECG report print at auto mode, the measured ECG data cannot
manual save when the stored ECG data to file management (memory) print.

YM412i Operators Manual 65


Operation of YM412i

3) ECG data list


Show the stored ECG data list for the patient. After select the appropriate data, you can print,
send, delete and change of data.

Tip) Press the (FILE) key to directly access the ECG list window (without going
through the menu).

Figure 5-27. File Management ECGs List

Use the directional button to move the underline to the desired data, and press (Enter) to
select the data. Press (Enter) to bring the sub-menu like below. Choose the desired item.

Figure 5-28. File Management ECGs List Select

66 YM412i Operators Manual


Operation of YM412i

y Print: Print the selected data.

Figure 5-29. File Management Print the ECG Data

YM412i Operators Manual 67


Operation of YM412i

y Send: Transmit a data to PC through RS-232 or LAN.

Figure 5-30. File Management Transfer patient data

NOTE: Before the ECG data transfer to PC, the Mecalyzer(PC program) set to the
standby.

NOTE: Refer to the Mecalyzer manual for more information of the Mecalyzer (PC
program).

y Delete: Delete the selected data.

Figure 5-31. File Management Delete patient data

68 YM412i Operators Manual


Operation of YM412i

y Change: Change the data of the existing patient.

Figure 5-32. File Management Change the patient data

4) Delete All ECGs

File Management

Copy
Manual Save
ECG data list
Delete All ECGs

Delete all records?


[Yes] No

Figure 5-31. File Management Delete All ECGs

NOTE: Since the deleted patient or test record cannot be restored, caution must be
applied when deleting.
NOTE: The necessary time of data deleting is max. 10minutes.

YM412i Operators Manual 69


Operation of YM412i

11. Maintenance
Refer to this manual for Chapter 6. Cleaning and Maintenance -> 10. Device Management.

70 YM412i Operators Manual


Cleaning and Maintenance

Chapter 6. Cleaning and Maintenance

YM412i Operators Manual 71


Cleaning and Maintenance

Warning: Disconnect the device from the power line before cleaning or
disinfecting its surface.

Warning: The cover should be removed only by qualified service personnel.


There are no internal user-serviceable parts except for the battery.

Warning: Do not spray, pour, or spill any liquid on the device, its accessories,
connectors or openings in the chassis.

Caution: Wipe the external surfaces of the cardiograph, patient cable and
electrodes with a soft cloth dampened in any of the approved cleaning
solutions.

1. Cleaning the Cardiograph


Wipe the device clean with a moist cloth. Do not let liquid enter the device. All cleaning
agents and disinfectants that contain alcohol and are commonly used in hospitals are
suitable, but do not use disinfectants on a phenol base or peroxide compounds.

2. Cleaning the Patient Cable and Electrodes

Patient Cable
1) Disconnect the cable from the device before cleaning or disinfecting it. When
disconnecting the cable, be sure to pull on the connector, not on the cable.
2) Clean the cable by rubbing it down with a cloth moistened with soap water. Use a
disinfectant for disinfection. Do not immerse the cable in liquid.

Electrodes
In addition to the information given in this manual, observe the instructions for use of the
respective electrode types.
1) Discard disposable adhesive electrodes immediately after use to prevent that they are
reused.
2) Clean reusable electrodes immediately after removing them from the patient.
3) Peel off the adhesive foil before cleaning the electrodes (rests of the adhesive can be
removed with benzene).
4) Then use warm water and a small brush to clean the electrodes of cream or gel. Do not

72 YM412i Operators Manual


Cleaning and Maintenance

use pointed or sharp objects for cleaning.


5) Disinfect the electrodes with alcohol-free disinfectant. Ensure that connectors and sockets
do not become wet.

3. Cleaning the Printer Head


1) Unclean printer head can be cause of reducing print quality.
2) Open the printer cover and then wipe it softly without rubbing it too hard by wetting swab
with 90% alcohol.
3) After cleaning, dry printer head sufficiently and then use it.

Figure 6-1. Cleaning the Printer Head

4. Storing Thermal Paper


1) Store the paper in suitable rooms at a temperature between 18 and 24 and relative
humidity between 40% and 60%.
2) Avoid direct contact of the paper with
- carbon and carbonless forms
- chart papers and adhesives containing tributyl phosphate, dibutyl phthalate, or any other
organic solvents
- document protectors, envelopes, and sheet separators containing plasticizers.
- solvents or solvent-based products containing alcohols, ketones, esters, or other
substances from this chemical group.
3) Printout paper discoloration may occur at unsuitable environment (temperature, humidity
or period (with in 1year)).

5. Recycling and Disposal


When the device, battery, or accessories reach the end of useful life, recycle or dispose of
the equipment according to appropriate local and regional regulations.

YM412i Operators Manual 73


Cleaning and Maintenance

6. Returning the Components


Contact the service center of Mediana for shipping instructions including a Returned Goods
Authorization number. Pack the device with accessories in its original shipping carton. If the
original carton is not available, use a suitable carton with appropriate packing material to
protect the device during shipping.

7. Service
This device requires no routine service other than cleaning, battery maintenance, and
service activity which is mandated by users institution. For more information, refer to the
service manual. Qualified service personnel in the users institution should perform periodic
inspections of the device. If service is necessary, contact qualified service personnel or
Mediana service center.

8. Checks before each use


Before each use, visually inspect the device, the leads and electrodes for mechanical
damage. If you detect damages or impaired functions that may adversely affect the safety of
the patient or user, do not use the device before it has been repaired.

9. Periodic Visual Inspection


Perform a visual inspection of all equipment and peripheral devices daily. Turn off the unit
and remove power before making an inspection or cleaning the unit.
1) Check the case and display screen for cracks or other damage.
2) Regularly inspect all cords and cables for fraying or other damage.
3) Verify that all cords and connectors are securely seated.
4) Check that the device labeling relevant for safety is legible.

10. Device Management


MENU


Maintenance

Move shadow box( ) to the Maintenance, and press (ENTER) key to show the

password input window. Input the password 1560, and press (Enter) to show the
maintenance window.

74 YM412i Operators Manual


Cleaning and Maintenance

Configuration

Operation Mode [Auto] [Manual]


System Setup
Patient Data
File Management
Maintenance
Maintenance

Enter Password

Maintenance

Demo Mode On Off


LCD Test Enter
Printer Test Enter
Firmware Ver. Enter

Figure 6-2. Maintenance Menu Screen

1) Demo Mode
If set to On, normal ECG signal will be applied.

2) LCD Test

To verify or optimize cardiograph LCD state, use the LCD test. Move shadow box( )

to LCD Test, and press (ENTER) key to display the test screen. If something is the matter
with the LCD, contact qualified service personnel or Mediana service center.

YM412i Operators Manual 75


Cleaning and Maintenance

3) Printer Test
The Printer Test is used to verify that the cardiograph printer is able to correctly print the test
page. Use this to verify proper printer performance or when reports appear to have print
quality errors.

Move shadow box( ) to Printer Test, and press (ENTER) key to print the printer test

page. If something is the matter with the test page, clean the printer header. The method of
printer cleaning refers to Chapter 6. Cleaning and Maintenance. Contact qualified service
personnel or Mediana service center. if problem persists after printer header cleaned.

4) Firmware Ver.

Move shadow box( ) to firmware Ver., and press (ENTER) key to show the firmware

version.

Maintenance

Demo Mode On Off


LCD Test Enter
Printer Test Enter
Firmware Ver. Enter

YM412i Ver1.0/1.0
2006-2007 Mediana Co.,Ltd.

Figure 6-3. Maintenance Firmware Version

76 YM412i Operators Manual


Cleaning and Maintenance

11. Battery Maintenance

Caution: Follow local government ordinances and recycling instructions


regarding disposal or recycling of device components, including batteries.

If the device has not been used 2 or more months, the Ni-MH battery will need charging. To
charge the battery, connect the device to an AC power source.

NOTE: Storing the device for 2 or more months without charging the battery may
degrade the battery capacity. Before using the battery, charge it for at least 6
hours before use.

NOTE: The battery should be removed from the device if placed in storage or will
not be used for a long period.

Mediana recommends that the devices Ni-MH battery be replaced if it has been stored for
2years or more. Refer to the service manual for battery replacement.

12. Firmware Upgrade


This section is for the purpose for reloading firmware in the device when the possibility of
corrupted firmware exists, or upgrading firmware with a new system version. The USB
Memory required for firmware upgrade.
Caution: After new firmware uploading is completed, the device should set to
the default. When system setup is not default, the device is not normal
operation.

Caution: If any problem during Firmware upgrade, contact the Mediana service
center. It may be fail in according with the type of USB memory.

1) Turn the device off.


2) The new firmware (Folder name: Y412update) inserted in the USB memory.
3) Connect the USB memory and device.
4) After turn on the YM412i, booting screen appears. Before finish the booting screen, press

ENTER
ESC
RUN
(ESC) and then press (Enter).

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Cleaning and Maintenance

5) The device will display the firmware update screen as shown below figure 6-4.
6) The firmware upgrades by it self.

Figure 6-4. Firmware upgrading Screen

7) After completion of upgrade, the device default setting at [MENU System Setup
Default Setting] set Yes.

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Troubleshooting

Chapter 7. Troubleshooting

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Troubleshooting

Warning: The cover should be removed only by qualified service personnel.


There are no internal user-serviceable parts except for the battery.

1. General
If the device detects an error, it can display an error code. The error codes are listed in the
service manual. If an error code is displayed, write down the code and contact your service
department. Before calling Mediana service center, make sure that the battery is charged
and that all power connections are in place.

Table 7-1. Troubleshooting


Symptom Cause Remedy
There is no response to Defective AC power Notify service to check and/or replace
the Power button. or fuse fuse
LCD screen is totally blue
color or white color (no It may be defective Do not use; contact qualified service
data is visible) when the LCD. personnel or Mediana service center.
power is turned on
Printer does not response Printer cover may be
Check the printer cover and paper.
even though printing related open. It may be no
Clean the printer header.
buttons are pressed. paper.
It may be defective Do not use; contact qualified service
Buttons do not respond.
keypad. personnel or Mediana service center.
Periodic superimposition Interference from the Verify position of the leadwires, switch
of AC line interference power line on AC line filter
Muscle artifact The patient should be warm enough
Superimposition of
caused by patient and resting comfortable. Comfort or
irregular AC line
movements, hiccup, distract patient, enable muscle filter, if
interference
coughing necessary.

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Troubleshooting

2. Error Description
The following errors are generated by YM412i to notify the user to take the necessary
response. When the following errors occur, Warning Beep makes a sound.

1) Printer cover open or No paper detect

This message with warning beep appears when the printer cover is not close or paper is not
supply. Check the printer cover and/or supply the paper.

2) Patient ID check error

This message with warning beep appears when patient ID is not entered at [MENU
System Setup Patient Data Entry Pat. ID Check] set Yes, Input the patient ID or
[MENU System Setup Patient Data Entry Pat. ID Check] set No.

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Troubleshooting

3) Birthday input error

This message with warning beep appears when the birthday is not entered or is out of the
realistic range (month: 1~12, day: 1~31). Check the date and then, input again.

4) Date input error

This message with warning beep appears when the date is not entered or is out of the
realistic range (month: 1~12, day: 1~31). Check the date and then, input again.

5) Time input error

This message with warning beep appears when the time is not entered or is out of the
realistic range (min: 1~59, hour: 1(0)~12(24)). Check the time and then, input again.

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Troubleshooting

6) Critical error

This message with warning beep appears when the device occur the critical problem. After
that, the device automatically shut down. After a while, turn on.
if problem persists, contact qualified service personnel or Mediana service center.

7) Input saturation warning error

This message with warning beep appears when the analog signal saturate.
After that, the device automatically adjusted.

8) Password input error

This message with warning beep appears when the password is not accurate. Check the
password and then, try again.

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Troubleshooting

9) Copy Deny error I

This message with warning beep appears when patient ID is not entered and press COPY
button at [MENU System Setup Patient Data Entry Pat. ID Check] set Yes. Input
the patient ID or [MENU System Setup Patient Data Entry Pat. ID Check] set No.

10) Copy Deny error II

This message with warning beep appears when press the COPY button at manual mode.

11) Copy Deny error III

This message with warning beep appears when press the copy button at [MENU
Automatic Mode No. of copy] set 0. [MENU Automatic Mode No. of copy] set 1~9.

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Troubleshooting

12) Manual Save Deny I

This message with warning beep appears when patient ID is not entered and press SAVE
button at [MENU System Setup Patient Data Entry Pat. ID Check] set Yes. Input
the patient ID or [MENU System Setup Patient Data Entry Pat. ID Check] set No.

13) Manual Save Deny II

This message with warning beep appears when ECG is not measured, press the SAVE
button.

14) Manual Save Deny III

This message with warning beep appears when ECG is not measured, press the COPY
button.

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Troubleshooting

15) Warning Low Battery

This message appears with warning beep when the battery is discharge. When warning
message Battery Low appears, all keys are not operation. After that, the device
automatically shut down. AC power cord shall be connected and then battery shall be
charged.

16) Memory Full


This message appears with warning beep when the memory is full. If select Yes, [Delete
Data and Save] message appears and the No.1 data delete and the new data save. If select
No, data is not save.

17) Update Error I

y This message appears with warning beep when USB memory does not insert or
recognize. Check the USB memory status.

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Troubleshooting

18) Update Error II

y This message appears with warning beep when executable file version of firmware same
the firmware version now in use. And this message appears in case of executable file of
the different ECG device.

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Troubleshooting

This page is intentionally left blank.

88 YM412i Operators Manual


Specification

Chapter 8. Specification

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Specification

Display
Type 103mm(W) X 77.22mm(H) STN mono LCD
Resolution 320 X 240 dots

Computerized Electrocardiograph
Basic - 100 ECGs (typical)
ECG Storage
Option 5000 cases in SD Card (1GB)
Pre-acquisition Provides 10s of instantaneous ECG acquisition
AC differential: 5mV
Dynamic Range
DC offset: 300mV
Sampling Rate 500Hz
Frequency Response 0.05 to 150Hz
Common Mode
100dB
Rejection
Input Impedance > 50
Patient Leakage
< 10
Current
Communication PC communication with RS232 interface and LAN
Firmware Upload Use the USB memory stick
AC: 50/60Hz
Low Pass Filter: 40, 100, 150Hz
Filter
High Pass Filter: 0.05, 0.5Hz
Muscle Filter

Writer
Type Thermal dot array
Speeds 5, 10, 25, 50mm/sec
Numbers of Traces 3, 6 or 12 user-selectable
Sensitivity/Gain 5, 10, 20mm/mV
Speed Accuracy 5%
Amplitude Accuracy 5%
Paper Type/Size Thermal Roll, 110mm X 30m

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Specification

Electrical
Power Supply AC or Battery operation
AC Input 100-240VAC 50/60Hz, 70VA
Fuses Qty. 2, 250Vac T6.3AL, IEC(5x20mm)
12V 3.8Ah, Rechargeable Nickel Metal Hydride Cylindrical
Battery Type
Cell
150 basic reports (Auto Mode) or 5hours continuous
Battery Capacity
operation (without printing)
Battery Charge Time Approximately 6hours from total discharge

Physical
Dimension 351 X 268.5 X 63 (W x L x H) mm
Weight 2.7Kg (including battery) without paper

Environmental
Temperature range 10-45
Operating Conditions Humidity range 20%~95%(non-condensing)
Atmosphere Pressure: 700 to 1060 hPa
Temperature range -20~60
Storage/Transportation
Humidity range 10%~95%(non-condensing)
Condition
Atmosphere Pressure: 500 to 1060 hPa

Compliance
Classification Class I, Internally powered
Type of protection Type CF with defibrillation protection
Mode of operation Continuous
Degree of protection IPX 0
General 93/42/EEC Directives for medical devices
ISO9001:2000 Quality Management Systems -
Requirements
ISO13485:2003 Medical devices - Quality management
systems - Requirements regulatory purposes
ISO14971:2000 Medical devices - Application of risk
management to medical devices

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Specification

IEC60601-1: 1988+A1:1991+A2:1995 General


requirements for Safety
IEC60601-1-4: 1996+A1:1999 General Requirements for
safety collateral standard: programmable electrical
medical systems
ISO10993-1: 2003 Biological evaluation of medical
devices Part 1: Evaluation and testing
IEC60601-2-25:1993+A1:1999 Particular requirements for
Electrocardiograph
the safety of electrocardiographs
Electromagnetic IEC60601, sub clause 36
Compatibility IEC60601-1-2: 2001+A1:2004 Electromagnetic
compatibility - Requirements and tests
IEC61000-3-2:2000 Harmonic current emissions
IEC61000-3-3:1995+A1:2001 Voltage fluctuations/Flicker
Emissions
IEC61000-4-2:1995+A1:1998+A2:2001 Electrostatic
Discharge(ESD)
IEC61000-4-3:2002+A12002 Radiated RF
electromagnetic field
IEC61000-4-4:2004 Electrical fast transient/burst
IEC61000-4-5:1995+A1:2001 Surge current
IEC61000-4-6:1996+A1:2001 Conducted disturbances,
induced by RF field
IEC61000-4-8:1993+A1:2001 Power frequency(50/60Hz)
magnetic field
IEC61000-4-11:1994+A1:2001 Voltage dips, short
interruption and voltage variation on power supply input
lines
CISPR11(EN55011) RF Emissions Group 1, Class B
EN1041:1998 Information supplied by the manufacturer
Labeling
with medical devices
EN980:2003 Graphical symbols for use in the labeling of
Marking
medical devices

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Specification

Manufacturers Declaration

Warning: For best product performance and measurement accuracy, use only
accessories supplied or recommended by manufacturer. Use accessories
according to the manufacturers directions for use and your facilitys
standards. The use of accessories and cables other than those specified may
result in increased emission and/or decreased immunity of the YM412i
electrocardiograph.

The YM412i Electrocardiograph is suitable for use in the specified electromagnetic


environment. The customer and/or user of the YM412i electrocardiograph should assure that
it is used in an electromagnetic environment as described below.

Table 8-1. Electromagnetic Emissions (IEC60601-1-2)


Electromagnetic Environment -
Emission Test Compliance
guidance
The YM412i electrocardiograph uses
RF energy only for its internal
RF emission function. Therefore, its RF emissions
Group 1
CISPR 11 are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emission
Class B
CISPR 11
Harmonic emissions
Class A
IEC61000-3-2
Voltage fluctuations/
flicker emissions Complies
IEC61000-3-3

Table 8-2. Electromagnetic Immunity (IEC60601-1-2)


IEC 60601 Compliance Electromagnetic Environment -
Immunity Test
test level level guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or
discharge (ESD) 8 kV air 8 kV air ceramic tile. If floors are covered with

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Specification

IEC 60601 Compliance Electromagnetic Environment -


Immunity Test
test level level guidance
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
2 kV for power 2 kV for power
Electrical fast supply lines supply lines Mains power quality should be that of a
transient/burst 1 kV for 1 kV for typical commercial or hospital
IEC 61000-4-4 input/output input/output environment.
lines lines
1 kV differential 1 kV differential
Mains power quality should be that of a
Surge mode mode
typical commercial or hospital
IEC 61000-4-5 2 kV common 2 kV common
environment.
mode mode
<5 % UT <5 % UT
(>95 % dip in (>95 % dip in
UT) for 0,5 cycle UT) for 0,5 cycle
Mains power quality should be that of a
Voltage dips,
40 % UT 40 % UT typical commercial or hospital
short
(60 % dip in UT) (60 % dip in UT) environment. If the user of the YM412i
interruptions and
for 5 cycles for 5 cycles electrocardiograph requires continued
voltage
operation during power mains
variations
70 % UT 70 % UT interruptions, it is recommended that
on power supply
(30 % dip in UT) (30 % dip in UT) the YM412i electrocardiograph be
input lines
for 25 cycles for 25 cycles powered from an uninterruptible power
IEC 61000-4-11
supply or a battery.
<5 % UT <5 % UT
(>95 % dip in (>95 % dip in
UT) for 5 sec UT) for 5 sec
Power frequency Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
3A/m 3A/m
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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Specification

Table 8-3. Electromagnetic Immunity (IEC60601-1-2)


IEC 60601 Compliance Electromagnetic Environment -
Immunity Test
test level level guidance
The YM412i electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of the YM412i electrocardiograph should assure that it is used in
such an environment.
Portable and mobile RF
communications equipment should be
used no closer to any part of the
YM412i electrocardiograph, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommend separation distance

Conducted RF 3 Vrms 3Vrms


IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m where P is the maximum output power


IEC 61000-4-3 80MHz to 800MHz rating of the transmitter in watts (W)
according to the transmitter
3 V/m 3 V/m manufacturer and d is the
800MHz to 2.5GHz recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

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Specification

IEC 60601 Compliance Electromagnetic Environment -


Immunity Test
test level level guidance
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 YM412i electrocardiograph is used exceeds the applicable RF
compliance level above, the YM412i electrocardiograph should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the YM412i electrocardiograph.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 8-4. Recommended Separation Distances


Recommended separation distances between
portable and mobile RF communications equipment and the YM412i electrocardiograph
The YM412i electrocardiograph is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the YM412i
electrocardiograph can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
YM412i electrocardiograph as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum Separation distance according to frequency of transmitter in meter
Output power of
150 kHz to 80 MHz 80MHz to 800MHz 800MHz to 2.5GHz
Transmitter in
watt
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation

96 YM412i Operators Manual


Specification

Recommended separation distances between


portable and mobile RF communications equipment and the YM412i electrocardiograph
distance d in metres(m) can be determined 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.

Table 8-5. Cables (IEC60601-1-2)


Cables Length(m) Complies with
- RF emissions, CISPR 11,
Power cable, Unshielded 1.8 ClassB/Group1
- Harmonic emissions, IEC61000-3-2
- Voltage fluctuations/flicker emission,
RS232C cable, Shielded 1.8 IEC61000-3-3
- Electrostatic discharge(ESD),
IEC61000-4-2
LAN cable, Shielded 20.0 - Electric fast transient/burst,
IEC61000-4-4
- Surge, IEC61000-4-5
ECG Lead cable,
3.7 - Conducted RF IEC61000-4-6
Shielded
- Radiated RF, IEC61000-4-3

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