L05321-08 20130425 MeCA812i OPM (EN)

MeCA812i
ELECTROCARDIOGRAPH
Operator’s Manual
MeCA812i
Operator’s Manual
MEDIGATE Inc.
1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea
Tel: (82) 33 747 3552 Fax: (82) 33 747 3691
Obelis s.a,
Bd. Général Wahis 53 1030 Brussels, BELGIUM
MeCA812i Operator’s Manual

Part Number-Revision Number: L05321-08
Date of Revision: 2013-04-25
Printed in Korea
Copyright© 2007 Medigate Inc. 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.
Medigate 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. Medigate 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 Medigate Service Center ................................................................................ 25
Chapter 3. Putting the device ................................................................................................... 27

1. List of Components ............................................................................................................... 28
2. Power Cable Connection ...................................................................................................... 29
3. Rechargeable Battery Operation ......................................................................................... 30
4. Installation and Mains Connection ...................................................................................... 32
5. Loading the Printer Paper .................................................................................................... 32
6. External Interface Connector ............................................................................................... 33
7. Understanding the ECG analysis ......................................................................................... 33
Chapter 4. Preparations for ECG Recording .......................................................................... 35

1. Connecting the patient cable ............................................................................................... 36
2. Electrode Application ............................................................................................................ 37
3. Position of electrodes ........................................................................................................... 37
4. Connecting the SD card ........................................................................................................ 39
5. SD card Application .............................................................................................................. 39
Chapter 5. Operation of MeCA812i .......................................................................................... 40

1. Turn on the MeCA812i ........................................................................................................... 41
2. Automatic Mode Recording .................................................................................................. 42
3. Manual Mode Recording ....................................................................................................... 42
4. Turn off the MeCA812i .......................................................................................................... 42
5. System Menu ......................................................................................................................... 43
6. Menu Configuration .............................................................................................................. 45
7. Operation Mode ..................................................................................................................... 46
8. System Setup ......................................................................................................................... 58
9. Patient Data ............................................................................................................................ 66
10. File Management ................................................................................................................. 70
11. Maintenance ......................................................................................................................... 74
Chapter 6. Cleaning and Maintenance .................................................................................... 75

1. Cleaning the Cardiograph .................................................................................................... 76
2. Cleaning the Patient Cable and Electrodes ........................................................................ 76
3. Cleaning the Printer Head .................................................................................................... 77
4. Storing Thermal Paper .......................................................................................................... 77
5. Recycling and Disposal ........................................................................................................ 78
6. Returning the Components .................................................................................................. 78
7. Service .................................................................................................................................... 78
8. Checks before each use ....................................................................................................... 78
9. Periodic Visual Inspection .................................................................................................... 78
10. Device Management ............................................................................................................ 79
11. Battery Maintenance ........................................................................................................... 81
12. Firmware Upgrade ............................................................................................................... 81
Chapter 7. Troubleshooting ...................................................................................................... 83

1. General ................................................................................................................................... 84
2. Error Description ................................................................................................................... 85
Chapter 8. Specification ........................................................................................................... 93

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 ………………………………………………………………… 29
Figure 3-2. Recording paper insertion…………………………………………………… 32
Figure 3-3. Interface Connector…………………………………………………………… 33
Figure 3-4. Automatic Mode Report……………………………………………………….. 34
Figure 4-1. Patient Cable Connector……………………………………………………… 36
Figure 4-2. Patient Cable …………………………………………………………………… 36
Figure 4-3. Connecting position of the limb lead electrodes………………………… 37
Figure 4-4. Connecting position of the chest lead electrodes……………………… 38
Figure 4-5. Arranging the patient cable…………………………………………………. 38
Figure 4-6. SD card Connector…………………………………………………………….. 39
Figure 4-7. 1G SD card……………………………………………………………………….. 39
Figure 5-1. Copyright Screen……………………………………………………………… 41
Figure 5-2. Typical screen of ECG………………………………………………………… 42
Figure 5-3. System MENU………………………………………………………………….. 43
Figure 5-4. MENU Configuration………………………………………………………….. 45
Figure 5-5. Automatic Mode Menu Screen………………..…………………………….. 46
Figure 5-6. Print Format 3*3R……………………………………………………………… 47
Figure 5-9. Print Format 6*NR……………………………………………………………… 50
Figure 5-10. Print Format 12*NR…………………………………………………………….. 51
Figure 5-11. Print Format 60s………………………………………………………………. 52
Figure 5-12. Rhythm Lead Setting Screen (Automatic Mode) ………………………... 53
Figure 5-13. Median Beats Report…………………………………………………………. 54
Figure 5-14. Detail Parameter Report……………………………………………………… 55
Figure 5-15. Manual Mode Menu Screen…………………………………………………... 56
Figure 5-16. Rhythm Leads Setting Screen (Manual Mode) …………………………... 57
Figure 5-17. System Setup Menu Screen…………………………………………………. 58
Figure 5-18. System Setup - Physician Setting Screen………………………………… 59
Figure 5-19. System Setup - Technician Setting Screen……………………………….. 59
Figure 5-20. System Setup – Beep Setting Screen……………………………………… 61
Figure 5-20a. System Setup –SET TCP/IP………………………………………………… 61
Figure 5-21. System Setup – Patient Data Entry Setting Screen……………………… 62
Figure 5-22. Patient Data – New Patient Registration Screen…………………………. 67
Figure 5-23. Patient Data – Race Input Screen…………………………………………… 68
Figure 5-24. Patient Data – Physician and Technician Selection Screen……………. 69
Figure 5-25. Patient Data – Madication Input Screen…………………………………… 69
Figure 5-26. File Management Menu Screen……………………………………………… 70
Figure 5-27. File Management – ECG List……………….………………………………... 71
Figure 5-28. File Management – ECG DATA List Screen………………………………... 71
Figure 5-29. File Management – Print the ECG Data..…………………………………… 72
Figure 5-30. File Management – Transfer patient data…………………………………... 73
Figure 5-31. File Management – Delete patient data……………………………………... 73
Figure 5-32. File Management – Delete All ECGs………………………………………… 74
Figure 6-1. Cleaning the Printer Head…………………………………………………..... 77
Figure 6-2. Maintenance Menu Screen…………………………………………………….. 79
Figure 6-3. Firmware upgrading Screen………………………….……………………….. 82
Tables
Table 2-1. Display Description …………………………………………………………… 20
Table 2-2. Key Description ………………………………………………………………… 21
Table 2-3. Panel and Label Symbols……………………………………………………… 23
Table 3-1. List of Components …………………………………………………………… 28
Table 3-2. Top panel indicator for power source……………………………………… 30
Table 3-3. Battery Charging Status Indications………………………………………… 31
Table 5-1. Lead Labels ……………………………………………………………………… 61
Table 5-2. Default Setting Value…………………………………………………………… 63
Table 7-1. Troubleshooting………………………………………………………………… 84
Table 8-1. Electromagnetic Emissions (IEC60601-1-2) ……………………………….. 97
Table 8-2. Electromagnetic Immunity (IEC60601-1-2) ………………………………… 97
Table 8-3. Electromagnetic Immunity (IEC60601-1-2) ………………………………… 99
Table 8-4. Recommended Separation Distances………………………………………. 100
Table 8-5. Cables (IEC60601-1-2) ………………………………………………………… 101
This page is intentionally left blank.
Information
Chapter 1. Information
MeCA812i Operator’s Manual 9

Information
1. General Information
 The product MeCA812i 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 Ⅱa (MDD) equipment.
 The product is designed to comply with IEC60601 requirements. It is a protection class I,
type CF device.
 The product complies with the electromagnetic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.
 The radio-interference emitted by this device is within the limits specified in
CISPR11/EN55011, class B.
 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.
 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.
 To ensure patient safety, the specified measuring accuracy, and interference-free operation,
we recommend to use only original Medigate components. The user is responsible for
application of accessories from other manufacturers.
 The warranty does not cover damage resulting from the use of unsuitable accessories and
consumables from other manufacturers.
 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 MeCA812i Operator’s 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

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 children’s 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
Medigate.
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.

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->Manufacturer’s
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: The possibility of bringing a danger it is pay attention due to

summation of leakage currents when several equipments are interconnected.
Warning: It was designed as Class I Protection, Type CF device. Therefore, the

electrocardiograph is suitable for direct application to the cardiac.

Information
Warning: This device will not cause abnormal operation of a patient’s

pacemaker or other electronic stimulator. But the device may be affected the
accuracy of the diagnosis by pacemaker or other stimulator.
Warning: A qualified physician must overread all interpretation results and

computer-generated tracings. Computerized interpretation is only significant
when used in conjunction with clinical findings.
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 sunlight.
Caution: Avoid vibration or mechanical shock.
Caution: Make arrangement so that patient cable may not be twisted. Incorrect
attachment of the electrode affects the accuracy of the diagnosis; therefore, it
is critical to attach the electrode at the correct place (Refer to the Ch.4).
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.

Information
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.
Caution: Service shall be performed by the designated professional technician

by all means.

Information

Introduction
Chapter 2. Introduction

Introduction
Caution: Medical technical equipment such as the MeCA812i 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.

Introduction
2. Description of control, display and symbols
Graphic LCD
Thermal
Printer
Keypad
Figure 2-1. Top Panel
LAN Connector AC Power Inlet

RS-232
Connector
USB Connector
GND Terminal
Figure 2-2. Rear Panel
Patient Cable SD Card Slot PS2

Connector
Figure 2-3. Right Panel

Introduction
Table 2-1. Display Description

Graphic LCD
1 2 3 4 5 6 7
10mm/mV 25mm/s 0.16Hz 100Hz 40Hz EMG Automatic
I V1
II V2
III V3
aVR V4
aVL V5
aVF V6
28/02/2007 AFS I II III 3 * 3R SD HR 060
8 13 9 10 12 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
6 Muscle Filter Elimination of muscle artifact (only automatic 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
12 SD card Indication of SD card
13 Anti Floating System Indication of AFS

Introduction
Table 2-2. Key Description

Keypad
Key Description
1 AC IN indicator(Green LED)
2 Power On indicator(Green LED)
3 Battery charging status indicator(Yellow LED)
4 Escape key(ESC)
5 Delete(Backspace)
6 Confirms entered data(Enter)
7 Power On/Off Button
8 Selects the Automatic Mode(Auto)
9 Selects the Manual Mode(Manual)
10 Enables entry of MENU(Menu)
11 Selects the filter (Filter)
12 Selects the writer speed 5, 10, 25, 50mm/s
13 Stop the printing in manual mode(Stop)
14 Selects the gain(5, 10, 20mm/mV)
15 Graphic LCD displays the configuration(3-6-12Ch) menu(GLCD)
16 Start the record in selected mode(Auto or Manual) (Run)
17 Enables entry of patient information(Patinet)
18 Cursor shift key

Introduction
Key Description
19 Space bar
Input the special character
In case of two LEDs off: input character
20
In case of green LED on: special character of character key
In case of orange color LED on: special character of number key
21 Change the capital letter / small letter

(LED ON: capital letter, LED OFF: small letter)

Introduction
Table 2-3. Panel and Label Symbols

Symbols Description
AC IN indicator(Green LED)
Power On indicator(Green LED)
Battery charging status indicator(Orange LED)
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

Introduction
RS-232 interface connector
SD Card Slot
PS2 Keyboard connector
CE mark
EU representative
Manufacturer
Date of manufacture
Crossed-out wheeled bin
Dust and water resistance
Consult accompanying document
REF Reference number

Introduction
SN Serial number
Environmental shipping/storage altitude limitations
Environmental shipping/storage altitude limitations
Environmental shipping/storage temperature limitations
Fragile-Handle with care
Keep dry.
This way up
Caution, Warning
3. Contacting a Medigate Service Center

The Medigate Service Center can assist with product troubleshooting and provide technical
expertise to help with any issue with the MeCA812i cardiograph or any of its accessories.
TEL +82-31-458-0977
FAX +82-31-458-0978

Introduction

Putting the device
Chapter 3. Putting the device

Putting the device
1. List of Components
Table 3-1. List of Components
① MeCA812i Main 1EA ② Clamp Electrodes 1Pack ③ Chest Electrodes 1Pack
④ Patient Cable 1EA ⑤ Power Cable 1EA ⑥ Thermal Paper 1Pack
⑨ Operator’s manual 1EA
⑦ Serial Cable 1EA ⑧ Ground Cable 1EA
NOTE: The above pictures vary from the original in some points.

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.
MeCA812i 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.
AC Power Input
Figure 3-1. AC Power Input
1) Connect the female connector end of the AC power cable to the device’s 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.

Putting the device
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
( Orange LED ON)
(Green LED ON)
AC IN
Power ON (Green LED ON)
Fully charged battery
(Orange LED ON)
(OFF)
AC OUT
Power ON (Green LED ON)
Battery operation
(OFF)
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 ① the power cord, ② the AC power inlet, ③
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;
orange LED on flashes while charging is under progress, and then the flashing stops
when charging is completed.

Putting the device
2) Battery status
If battery power is deficient, the battery capacity short warning “Low Battery” is displayed on
the screen. A warning message “Low Battery” appears and beep sounds before the device
shuts off. After that, the device automatically shut down. When warning message “Low
Battery” 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
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: When warning message “Low Battery” appears and beep sounds,
connect the device to AC Power Source. If AC power source is not connected
in low-battery condition, do not operate the File Management, Firmware
Upgrade, System Setup (Default setting) and External Interface because the
data can be lost and the device can be made an error.
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.

Putting the device
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

Replace the printer paper when a red stripe appears on the printed ECG report. Only use
Medigate replacement printer paper.
1) As shown in the Figure 3-2 below, open printer cover
2) Insert a new pack of printer paper with the printed side facing up. Ensure that no more than
200 sheets are being inserted into the paper tray.
3) Drape the entire first sheet over the roller. Ensure that the edge of the paper aligns with the
edge of the paper drawer.
4) Close the printer cover.
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.

Putting the device
6. External Interface Connector
LAN Connector
RS-232
Connector
USB 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 Medigate is not responsible for problems that occur when using non-
certified products.
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 ECG’s 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.

Putting the device
5) Automatic Mode Report
5
4 7
6
Figure 3-4. Automatic Mode Report
① ECG waveform: 12Leads ECG waveform-I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
② 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.
③ 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.
④ Patient Information: This information is entered by the technician when the ECG is taken.
⑤ System Information: Information about the settings at which the ECG was taken is listed
at the right of the Auto report.
⑥ 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.
⑦ Diagnosis Result: The measurements and interpretation can help the physician save
time when overreading reports.

Preparations for ECG Recording
Chapter 4. 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 (Figure 4-2) to patient cable connector (Figure 4-1).
Patient Cable
Connector
Figure 4-1. Patient Cable Connector
Figure 4-2. Patient Cable
Warning: For reasons of patient safety, use only the original Medigate patient
cable. Before connecting the cable to the device, check it for signs of
mechanical damage. Do not use a damaged cable.

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
Medigate electrode.
3. Position of electrodes
Lay the patient on the bed in a relaxed state and get rid of any tension on the muscle. Do not
move during measurement. 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
RA / R
LA / L
LL / F
RL / N
Figure 4-3. Connecting position of the limb lead electrodes

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

th
V1: Right side of the sternum in the 4 intercostals space
th
V2: Left side of the sternum in the 4 intercostals space
V3: Midway between V2 and V4
th
V4: Left midclavicular line in the 5 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.

Operation of MeCA812i
4. Connecting the SD card
SD card
Connector
Figure 4-6. SD card Connector
Figure 4-7. 1G SD card

5. SD card Application
sd card must use which supplied or authorized by MEDIGATE, Inc. Use right SD card to save
ECG data correctly.

Chapter 5. Operation of MeCA812i

1. Turn on the MeCA812i

1) Turn on the MeCA812i by pressing POWER button for about 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.
3) After the copyright screen disappears, the MeCA812i initiates operation with warning beep.
M812Boot-V0.0.1
50%
MeCA812i Ver 0.01/0.01
Figure 5-1. Copyright Screen

4) When the device detects valid signals, it displays real-time waveforms similar to Figure 5-2.
10mm/mV 25mm/s 0.16Hz 100Hz 40Hz EMG Atomatic
I V1
II V2
III V3
aVR V4
aVL V5
aVF V6
28/02/2007 AFS I II III 3 * 3R SD HR 060
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) While ECG report printing with the manual mode, it can change the sensitivity and speed.
4. Turn off the MeCA812i

Turn off the MeCA812i by pressing POWER button for over 2 seconds.

5. System Menu
Press MENU key in order to enter the menu. Pressing MENU key shows detailed
menus as follows.
Configuration
Auto
System Setup
Patient Data
File Management
Maintenance
Configuration
Manual
System Setup
Patient Data
File Management
Maintenance
Figure 5-3. System MENU – Automatic Mode and Manual Mode
 Shift of menu item: Navigate using (Up), (Down) keys. Shadow box
( ) highlights the menu item to be selected.

 Selection of menu item: Move shadow box ( ) to the desired item, and press
(Enter) to select the item.
 Changing the setting: Highlight the desired setting in the same manner as “selection
of menu item”, and press (Enter) to change the setting.

Configuration
Auto Manual
System Setup System Setup
Patient Data Patient Data
File Management File Management
Maintenance Maintenance
6. Menu Configuration
Operation Mode Operation Mode System Setup File

Patient Data Maintenance
(Automatic) (Manual) Physician Management
Technician New Patient
Gain Hospital Name
Speed Patient ID
Cart No. Last Name
Report Format Location No. First Name Copy Firmware Version
No.of Copy Date Format
Gain Date of Birth ECG Data List LCD Test
Rhythm Leads Date
Speed Height Delete All ECGs Printer Test
Interpretation Time Format
Rhythm Leads Weight ECG Save Demo
Print Interpretation Time (hh:mm)
Print Median Beat Gender
Units Race
Print Detail Result
Beep Pacemaker
Muscle Filter Lead Labels Physician
Figure 5-4. MENU Configuration

LCD Light Off Technician
MeCA812i Operator’s Manual

Communication Room No.
Patient Data Entry Medication1
High Cut-Off Filter Medication2
AC Line Filter On-Off Comments
AC Line Filter
Low Cut-Off Filter
Auto Save
Default Setting
Print Setup Menu List
Language
Page Detection
Sample Set
45
7. Operation Mode
1) Automatic Mode
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 3*3R Others
No. of Copy 1
Rhythm Leads I II III
Interpretation Yes No
Print Interpretation Yes No
Print Median Beat Yes No
Print Detail Result Yes No
Muscle Filter On Off
Figure 5-5. Automatic Mode Menu Screen
① Gain: Choose between three different amplitudes of electrocardiogram waveform
(5mm/mV, 10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired
amplitude, and press (Enter) to select.
Tip) Gain of electrocardiogram waveform is changed with (Gain) key by selecting

5㎜/㎷, 10㎜/㎷ and 20㎜/㎷.
② 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 electrocardiogram waveform is changed with (Speed) key

by selecting 5㎜/s, 10㎜/s, 25㎜/s and 50㎜/s.

③ Report Format: Report format can change by selecting 3*3R, 3*1R, 6*1R, 6*NR,
12*NR, 60s.
NOTE: If you set 60s mode, the speed setting value fixed 25mm/s.
NOTE: If you set 60s mode, Auto Save/Manual Save functions aren’t applied.
Figure 5-6 Print Format 3*3R

Figure 5-7. Print Format 3*1R

Figure 5-8. Print Format 6*1R

Figure 5-9. Print Format 6*NR

Figure 5-10. Print Format 12*NR

Figure 5-11. Print Format 60s

④ 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.
⑤ Rhythm Leads: 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.
Operation Mode (Automatic)

Report Format 3*3R Others
No. of Copy 1 I
Rhythm Leads I II III II
III
Interpretation Yes No aVR
Print Interpretation Yes No aVL
Print Median Beat Yes NOaVF
V1
Print Detail Result Yes NO V2
Muscle Filter On Off V3
V4
V5
V6
Figure 5-12. Rhythm Lead Setting Screen (Automatic Mode)
⑥ Interpretation: Choose whether to diagnose the cardiogram or not. If set to “Yes”,

diagnosis will process. If set to “No”, there will be no diagnosis.
Warning: A qualified physician must overread all interpretation results and

computer-generated tracings. Computerized interpretation is only significant
when used in conjunction with clinical findings.
⑦ 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”.

⑧ 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 5-13. Median Beats Report

⑨ 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. If “Print Median Beat” is set as “No”, “Print
Detail Result” is automatically set as “No”.
Figure 5-14. Detail Parameters Report
⑩ 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.
NOTE: After the stored ECG data to file management (memory) print, previously
measured ECG data in automatic mode cannot manual save.

2) Manual Mode
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
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.
Operation Mode (Manual)

Rhythm Leads I, II, III, aVR, aVL, aVF 12Ch
Figure 5-15. Manual Mode Menu Screen

① Gain: Choose between three different amplitudes of electrocardiogram waveform
(5mm/mV, 10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired
amplitude, and press (Enter) to select.
Tip) Gain of electrocardiogram waveform is changed with (Gain) key by

selecting 5㎜/㎷, 10㎜/㎷ and 20㎜/㎷.
② 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 electrocardiogram waveform is changed with (SPEED)

key by selecting 5㎜/s, 10㎜/s, 25㎜/s and 50㎜/s.

③ Rhythm Leads: The outputted wave’s leads can be selected. 2 different combination
sets are available ([I, II, III, aVR, aVL, aVF], [V1, V2, V3, 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 “3: [ , , , , , ]”, and
press (Enter) to bring the sub-menu like below. Choose the desired lead.
Tip) Rhythm Leads of cardiogram waveform is changed with (Up), (Down)
key by selecting No.1, 2, 3.
Operation Mode (Manual)

Rhythm Leads I, II, III, aVR, aVL, aVF 12Ch
Rhythm Leads
Selected Rhythm Lead: 1
1 I, II, III, aVR, aVL, aVF
2 V1, V2, V3, V4, V5, V6
3
Operation
OperationMode (Manual)
Mode(Manual)

Rhythm Leads I, II, III, aVR, aVL, aVF
I 12Ch
Rhythm Leads II
III
Selected Rhythm Lead: 1 aVR
aVL
1 I, II, III, aVR, aVL, aVF
aVF
2 V1, V2, V3, V4, V5, V6 V1
3 V2
V3
V4
V5
V6
Figure 5-16. Rhythm Leads Setting Screen(Manual Mode)

8. System Setup
System Setup
Physician [List Edit]

Technician [List Edit]
Hospital Name [ ]
Cart No. 000
Location No. 000
Date Format d/m/y m/d/y y/m/d
Date 00/00/0000
Time Format 12 24
Time(hh:mm) 00:00 AM PM
Units cm, kg in, lb
Beep On Off
Lead Labels IEC AAMI
LCD Light Off 10 (min) Off
Communication RS-232 TCP/IP
Patient Data Entry Select
System Setup
High Cut-Off Filter 40Hz 100Hz 150Hz Off

AC Line Filter On-Off On Off
AC Line Filter 60Hz 50Hz
Low Cut-Off Filter 0.5Hz 0.3Hz 0.16Hz 0.05Hz
Auto Save Yes No
Default Setting Yes No
Print Setup Menu List Print
Language English Others
Page Detection On Off
Sample Set Sample Pre-Sample
SDList Onepage All
AFS On Off
Figure 5-17. System Setup Menu Screen

Cleaning and Maintenance
1) Physician
Up to 10 physicians may be recorded. After input the desired Select No., press (Enter). Then a
text box that inputs name of the physician shows, and the desired text can be typed. The name
of a physician consists of 9-digit character.
Delete If delete the physician, after select the desired Delete No., press (Enter).
System Setup: Physician

Select: 0 Delete : 0
No. Last Name First Name
0 AAA BBB
1
2
3
4
5
6
7
8
9
Figure 5-18. System Setup - Physician Setting Screen
2) Technician
Up to 10 technicians may be recorded. After input the desired Select No., press (Enter). Then a
text box that inputs name of the physician shows, and the desired text can be typed. The name
of a technician consists of 9-digit character.
Delete If delete the technician, after select the desired Physician No., press (Enter).
System Setup: Technician

Select: 0 Delete : 0
No. Last Name First Name
0 AAA BBB
1
2
3
4
5
6
7
8
9
Figure 5-19. System Setup - Technician Setting Screen

3) Hospital Name
After move shadow box ( ) to “Hospital Name”, the desired text can be typed. Refer to
the text input tip when inputting the name of the hospital.
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 three different formats of date (dd/mm/yy (Day/Month/Year), mm/dd/yy
(Month/Day/Year) or yy/mm/dd(Year/Month/Day).
7) Date
Set the current date.
8) Time Format
Choose between two different formats of time (12 hour format or 24 hour format)
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 patient’s
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.

System Setup
Hospital Name [ ]
Cart No. 000
Location No. 000
Date Format d/m/y m/d/y y/m/d
Date 00/00/0000
Time Format 12 24
Time(hh:mm) 00:00
Units cm, kg in, lb
Beep On Off Beep
Heart Rate On Off
LCD Light Off 10 (min)
Key Press On Off
Warning On Off
Figure 5-20. 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
13) LCD Light Off

Set the LCD light time. If set “Off”, LCD Light is not off.
14) Communication
When transport ECG data to PC, can select the way of PC communication RS-232, or LAN.
Input device IP address and IP address of HOST PC when select LAN. And input same Port
No. as Mecalyzer.
System Setup

Hospital Name SET
[ TCP/IP
]
Cart No. 000
Location No. IP 000
192.168.001.221
Date Format d/m/y m /d/y y /m/d
Date 00/00/0000
Time Format HOST 12192.168.001.104
24
Time(hh:mm) 00:00 AM PM
Port Nocm, kg
Units in , lb
Beep 4000
On Off
LCD Light Off 10 (min) Off
Figure 5-20a. System Setup – SET TCP/IP

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 Required Yes No
Figure 5-21. 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.
19) Low Cut-Off Filter

The high pass filter removes the baseline wondering of the low-frequency signal. Four modes
are available (0.5Hz, 0.3Hz, 0.16Hz 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
Highcut 40Hz [100Hz] 150Hz Off
Lowcut [0.5Hz] 0.3Hz 0.16Hz 0.05Hz
EMG [On ] Off
Manual Mode
Highcut 40Hz [100Hz] 150Hz Off
Lowcut [0.5Hz] 0.3Hz 0.16Hz 0.05Hz
20) Auto Save

Choose whether to conduct auto-save or not.
NOTE: Auto Save is not applied in the 60s Mode.
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

Gain 10mm/mV
Speed 25mm/s
Report Format 3 X 3R
No. of Copy 1 (range 1~9)
Rhythm Leads I, II, III
Automatic Mode
Interpretation Yes
Print Interpretation Yes
Print Median Beat No
Print Detail Result No
Muscle Filter Off
Manual Mode Gain 10mm/mV

Speed 25mm/s
Rhythm Leads I, II, III, aVR, aVL, aVF
Physician List Delete all list
Technician List Delete all list
Hospital Name Empty
Cart No. 001
Room No. 001
Date Format d/m/y
Date Current Date
Time Format 12
Time(hh:mm) Current Time AM/PM
Units cm, kg (range: 0-399)
Beep All beep off
Lead Labels IEC
System Setup LCD Light Off 20 min (range: 1~99min)
Communication RS-232
High Cut-Off Filter 100Hz
AC Line Filter On-Off On
AC Line Filter 50Hz or 60Hz
Low Cut-Off Filter 0.16Hz
Auto Save No
Default Setting No
Language English
Page Detection On
Sample Set Sample
SDList Onepage
AFS On
Height Yes
Weight Yes
Gender Yes
Patient Data Entry Race Yes
Pacemaker Yes
Physician Yes
Technician Yes

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 Information
Pacemaker No
Physician Non-select
Technician Non-select
Room No. 00000
Medication1 No
Medication2 No
Comments1 Empty
Comments2 Empty
Comments3 Empty
Copy -
ECG Data List
File Management
Delete All ECGs - Delete All Data
ECG Save -
Demo Mode No
LCD Test -
Maintenance
Printer Test -
Firmware Version -
AC Default Value 60Hz
Equipment Management
External Memory Off
22) Print Setup Menu List
Print the current setting values.

23) Language
Set the desired language.
24) Page Detection

Choose whether to conduct detection of paper start point or not.
25) Sample Set
Choose between Sample mode (When Sample Set is set as Sample, 10s ECG data sampled
from the time of pressing RUN key will be recorded while recording.) or Pre-sample mode
(When Sample Set is set as Pre-sample, 10s ECG data sampled before pressing RUN key will
be recorded while recording).
26) SDList
Choose whether print 60 latest data list in SD card or print all data list in SD card.
27)AFS
Set Anti Floating System which used for signal stabilization when the signal floating or drifting.
9. Patient Data
Input the information 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 000000000
Last Name [ ]
First Name [ ]
Date of Birth 00.00.0000 (dd.mm.yyyy)
Height 000 cm
Weight 000 kg
Gender Male Female
Race No Others
Pacemaker Yes No
Physician No Others
Technician No Others
Room No. 00000
Medication 1 No Others
Comments [1]
[2]
[3]
Figure 5-22. Patient Data – New Patient Registration Screen
2) Patient ID
The ID of a patient consists of 9-digit number.
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. The name of a patient
consists of 9-digit character.

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”.
(Input range: cm, kg – 0~399, in – 0~119, lb – 0~666)
6) Gender
Input the gender of the patient.
7) Race
Choose and input the patient’s race.
Patient Data
New Patient Yes NO

Caucasian
Patient ID 000000000 Black
Last Name [ ]
First Name [ ] Asian
Oriental
Height 000 cm Hispanic
Weight 000 kg Native American
Gender Male Eskimo
Female
Race No Pacific
OthersIsland
Pacemaker Yes Hawaiian
NO
Physician No Others
Mongolian
No
Room No. 00000
Comments [1]
[2]
[3]
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.

Patient Data Patient Data
New Patient Yes No New Patient Yes No

Patient ID 000000000 Patient ID 000000000
Last Name [ ] Last Name [ ]
First Name [ ] First Name [ ]
Date of Birth 00.00.0000 (dd.mm.yyyy) Date of Birth 00.00.0000 (dd.mm.yyyy)
Height 000 cm Height 000 cm
Weight 000 kg Weight 000 kg
Gender Male Female Gender Male Female
Race No Others Race No Others
Pacemaker Yes No Pacemaker Yes No
Physician No Others
No Physician No Others
No
Sang-hun Technician No Others
00000
Sang-hun
Room No. Kwang-seok Room No. 00000
Medication 1 No Others No Kwang-seok
So-hee Medication 1 Others
Medication 2 No Others Medication 2 No So-hee
Others
Comments [1] Chang-Jo Chang-Jo
Comments [1]
[2] Duck-hyun [2] Duck-hyun
[3] Ki-su [3] Ki-su
Figure 5-24. Patient Data – Physician and Technician Selection Screen
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.
Patient Data
New Patient Yes No

Patient ID 000000000
Last Name [ ]
First Name [ ] No
Digitalis
Height 000 cm
Weight 000 kg
Diuretics
Gender Male Antidepress
Female
Race No Steroids
Others
Pacemaker Yes Nitrates
No
Physician No ACE Others
Cytostatics
Room No. 00000
Comments [1]
[2]
[3]
Figure 5-25. Patient Data – Madication Input Screen
12) Comments [1], [2], [3]

Input the physician’s comments about the patient.

10. File Management
File Management
Copy
ECG Data List
Delete All ECGs
Manual Save
SD init
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).
NOTE: Copy is not applied in the 60s Mode.
Tip) Use (Copy) key to print directly (without going through Menu->File
Management->Copy)
NOTE: After the stored ECG data to file management (memory) print, previously
measured ECG data in automatic mode cannot copy.
2) 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) key to print directly (without going through Menu->File Management-

>ECG Data List)

Move shadow box ( ) to the [Print Directory], and press (Enter) to print
the ECG list.
[Print Directory] [Internal] External Memory
No. FirstName Pat ID ECG Taken

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Figure 5-27. File Management – ECGs List
Use the directional button to move the underline to the desired data, and press (space) to
select the data. Press (Enter) to bring the sub-menu like below. Choose the desired item.
No. FirstName Pat ID ECG Taken

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Please Select
Print Send Delete Change
Figure 5-28. File Management – ECG DATA List Screen

 Print: Print the selected data.
No. FirstName PAT ID ECG Taken

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Read the ECG Data
Please wait

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Diagnose
Please wait

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Printing
Please wait
Figure 5-29. File Management – Print the ECG Data

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

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Transfer ECG Data
Please wait
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).
 Delete: Delete the selected data.

2 ABC 314 27/03/07 13:27
1 DEF 313 01/03/07 17:07
Delete ECG Data
Please wait
Figure 5-31. File Management – Delete patient data

 Change: Press (Change) to change the data of the existing patient.
3) Delete All ECGs
File Management
Copy
ECG Data List
Delete All ECGs
Manual Save
SD init
Delete All ECGs?
[Yes] No
Figure 5-32. 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.
4) ECG Data 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->ECG Save)
5) SD init: Use when SD card initialization
11. Maintenance
Refer to this manual for “Chapter 6. Cleaning and Maintenance -> 10. Device Management”.

Chapter 6. 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
1) Clean reusable electrodes immediately after removing them from the patient.
2) Peel off the adhesive foil before cleaning the electrodes (rests of the adhesive can be
removed with benzene).
3) Then use warm water and a small brush to clean the electrodes of cream or gel. Do not
use pointed or sharp objects for cleaning.
4) 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.
6. Returning the Components

Contact the service center of Medigate 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 user’s institution. For more information, refer to the
service manual. Qualified service personnel in the user’s institution should perform periodic
inspections of the device. If service is necessary, contact qualified service personnel or
Medigate 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
→ Maintenance
Move shadow box( ) to the Maintenance, and press (ENTER) key to show the
password input window. Input the password “9105”, and press (Enter) to show the
maintenance window.
NOTE: Input the number in a state of Green LED On after press key.
Configuration
Automatic Mode
System Setup
Patient Information
File Management
Maintenance
Maintenance
Please enter your secret code...
Maintenance
Firmware Version MEDIGATE MeCA812i Ver 0.01/0.01

LCD Test Enter
Printer Test Enter
Demo Mode Yes No
SD card 12345
Figure 6-2. Maintenance Menu Screen

1) Firmware Ver.
Show the firmware version.
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 Medigate service center.
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 Medigate service center. if problem persists after printer header cleaned.
4) Demo Mode
If set to “On”, normal ECG signal will be applied.
5) SD card
Unblock SD card. Please contact to MEDIGATE, Inc. Service team to get registration key
number. When it registered, it dislays ON instead 5 digits number.

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.
Medigate recommends that the device’s Ni-MH battery be replaced if it has been stored for
2years or more. Refer to the service manual for battery replacement. Only qualified
personnel should replace the old battery with new battery.
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 Medigate 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: M812update) inserted in the USB memory.
3) Connect the USB memory and device.
4) After turn on the MeCA812i, booting screen appears. Before finish the booting screen,
press (ESC) and then press (A).

5) The device will display the firmware update screen as shown below figure 6-4.
6) The firmware upgrades by it self.
Application Update
Please wait
Recognition…
Reading…
Writing...
Figure 6-3. Firmware upgrading Screen
7) After completion of upgrade, the device default setting at [MENU ► System Setup ►
Default Setting] set “Yes”.

Troubleshooting
Chapter 7. Troubleshooting

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 Medigate 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 or Notify service to check and/or replace
the Power button. fuse fuse
LCD screen is totally
blue color or white color
It may be defective Do not use; contact qualified service
(no data is visible)
LCD. personnel or Medigate service center.
when the power is
turned on
Printer does not response
Printer cover may be
even though printing Check the printer cover and paper.
open. It may be no
related buttons are Clean the printer header.
paper.
pressed.
Page Detection or Printer Damaged sensor or Use temporarily after set to [System
Cover Open function Other company’s paper Setup -> Page Detection -> Off]. And
does not operated. use. then contact Medigate service center.
It may be defective Do not use; contact qualified service
Buttons do not respond.
keypad. personnel or Medigate service center.
Periodic
Interference from the Verify position of the leadwires, switch
superimposition of AC
power line on AC line filter
line interference
The patient should be warm enough
Superimposition of Muscle artifact caused
and resting comfortable. Comfort or
irregular AC line by patient movements,
distract patient, enable muscle filter, if
interference hiccup, coughing
necessary.

Troubleshooting
In spite of normal Connection error of

Check connection between
signal, diagnosis result between clamp/chest
clamp/chest and cable & electrodes
print frequently and cable or Electrode
and then, try again.
abnormal. contact error
2. Error Description
The following errors are generated by MeCA812i to notify the user to take the necessary
response. When the following errors occur, Warning Beep makes a sound.
1) Printer cover open or End of Paper
Cover Open or End of Paper
Check and Try Again
 Print start: 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.
 In mid print: This message with warning beep appears and then print stop.
2) Patient ID Error
Patient ID Error
Press ESC Key and ID Required
This message with warning beep appears when patient ID is not entered at [MENU ►
System Setup ► Patient Data Entry ► Patient ID Required] set “Yes”, Input the patient ID or
[MENU ► System Setup ► Patient Data Entry ► Patient ID Required] set “No”.
3) Birthday Error
Birthday Error
Please Press ESC Key and Input Again
This message with warning beep appears when the birthday is not entered or is out of the

Troubleshooting
realistic range (month: 1~12, day: 1~31). Check the date and then, input again.
4) Date Error
Date Error
Press ESC Key and Input Again
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 Error
Date 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.
6) Figure Error
Figure Error
This message with warning beep appears when the weight/height is out of the realistic range
(0~399). Check the weight/height and then, input again.
7) Critical Error
Critical Error
Please Wait
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.

Troubleshooting
if problem persists, contact qualified service personnel or Medigate service center.
8) Password input error
Password Error
This message with warning beep appears when the password is not accurate. Check the
password and then, try again.
9) Copy Error I
Copy Error
Press ESC Key and Check ID
This message with warning beep appears when patient ID is not entered and press
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 Error II
Copy Error
Press ESC Key and Check Mode
This message with warning beep appears when press the button at manual mode.

Troubleshooting
11) Copy Error III
Copy Error
Press ESC Key and Measure ECG
This message with warning beep appears when ECG is not measured, press the
button.
12) Save Error I
Save Error
Press ESC Key and Check ID
This message with warning beep appears when patient ID is not entered and press
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) Save Error II
Save Error
Press ESC Key and Check Mode
button.

Troubleshooting
14) Save Error III
Save Error
Press ESC Key and Measure ECG
button.
15) Warning Low Battery
Low Battery
Connect AC Power Line
This message appears with warning beep when the battery is discharge. When warning
message “Low Battery” 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
Memory Full!
Delete Old Data and Save?
[Yes] No
Data Save
Please Wait
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.

Troubleshooting
17) Update Error I
Update Error
Check USB
Recognition…
100%
Reading…
100%
Writing...
100%
 This message appears with warning beep when USB memory does not insert or
recognize. Check the USB memory status.
18) Update Error II
Update Error
Check Firmware Name &Ver.

Recognition…
100%
Reading…
100%
Writing...
100%
 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.

Troubleshooting
19) Saturation
10mm/mV 25mm/s 0.5Hz 60Hz 40Hz EMG Automatic
I V1
II V2
III V3
aVR V4
aVL V5
aVF V6
28/02/2007 I II III 3Saturation

* 3R HR 060
This message with warning beep appears when the analog signal saturate.
After that, the device automatically adjusted.

Troubleshooting

Specification
Chapter 8. Specification

Specification
Display
Type 115.17mm(W) X 86.37mm(H) STN mono LCD
Resolution 320 X 240 dots
Computerized Electrocardiograph
Basic - 50 ECGs (typical)
ECG Storage
Option – 5000 ECGs in SD Card (1GB)
Pre-acquisition Provides 10s of instantaneous ECG acquisition
AC differential: ±5mV
Dynamic Range
DC offset: ±300mV
Sampling Rate 1000Hz
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 Line Filter: 50/60Hz
Low Pass Filter: 40, 100, 150Hz
Filter Baseline Filter: 0.05, 0.16, 0.3, 0.5Hz
Muscle Filter
Anti Floating System(AFS)
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 Z-fold type / 282mmx215mm(WxL)

Specification
Electrical
Power Supply AC or Battery operation
AC Input 100-240VAC 50/60Hz, 110VA
Qty. 2, 250Vac T3.15AL in primary circuit
Fuses
Qty. 1, 250Vac T10.0AL in battery protection circuit
14.4V 3.8Ah, Rechargeable Nickel Metal Hydride
Battery Type
Cylindrical Cell
200 single-page reports or 5hours continuous
Battery Capacity
operation(without printing)
Battery Charge Time Approximately 6hours from total discharge
Physical
Dimension 385 × 367 × 101 (W x L x H) mm
Weight 4.5Kg (including battery) without paper
Environmental
Temperature range 10-45℃
Operating Conditions Humidity range 20%~95% (not condensing)
Atmosphere Pressure: 700 to 1060 hPa
Temperature range -20~60℃
Storage/Transportation
Humidity range 10%~95% (not 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
ISO13485:2003 Medical devices - Quality management

systems - Requirements regulatory purposes
ISO14971:2000/A1:2003 Medical devices - Application of
risk management to medical devices

Specification
Compliance
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

Specification
Manufacturer’s Declaration
Warning: For best product performance and measurement accuracy, use only
accessories supplied or recommended by manufacturer. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards. The use of accessories and cables other than those specified may
result in increased emission and/or decreased immunity of the MeCA812i
electrocardiograph.
The MeCA812i Electrocardiograph is suitable for use in the specified electromagnetic

environment. The customer and/or user of the MeCA812i 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 MeCA812i 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

Specification

Immunity Test
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
interruptions and
for 5 cycles for 5 cycles MeCA812i electrocardiograph requires
voltage
continued operation during power
variations
70 % UT 70 % UT mains interruptions, it is recommended
on power supply
(30 % dip in UT) (30 % dip in UT) that the MeCA812i electrocardiograph
input lines
for 25 cycles for 25 cycles be powered from an uninterruptible
IEC 61000-4-11
power 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.

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

Immunity Test
The MeCA812i electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of the MeCA812i 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
MeCA812i 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
a
electromagnetic site survey, should be
less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

Specification

Immunity Test
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 MeCA812i electrocardiograph is used exceeds the applicable
RF compliance level above, the MeCA812i electrocardiograph should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the MeCA812i 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 MeCA812i electrocardiograph
The MeCA812i electrocardiograph is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the MeCA812i
electrocardiograph can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
MeCA812i 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

Specification
Recommended separation distances between

portable and mobile RF communications equipment and the MeCA812i 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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MeCA812i

MeCA812i Operator’s Manual

Date of Revision: 2013-04-25

Copyright© 2007 Medigate Inc. All rights reserved.

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

Chapter 3. Putting the device ................................................................................................... 27

Chapter 4. Preparations for ECG Recording .......................................................................... 35

Chapter 5. Operation of MeCA812i .......................................................................................... 40

Chapter 6. Cleaning and Maintenance .................................................................................... 75

Chapter 7. Troubleshooting ...................................................................................................... 83

Chapter 8. Specification ........................................................................................................... 93

MeCA812i Operator’s Manual 9

10 MeCA812i Operator’s Manual

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

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

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

MeCA812i Operator’s Manual 11

a result of the proposed combination of devices.

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

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

Warning: Operator shall not touch patient and equipment simultaneously.

12 MeCA812i Operator’s Manual

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

Warning: It is possible that noises beyond guaranteed from immunity

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

Warning: The possibility of bringing a danger it is pay attention due to

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

MeCA812i Operator’s Manual 13

Warning: This device will not cause abnormal operation of a patient’s

Warning: A qualified physician must overread all interpretation results and

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

Caution: Avoid vibration or mechanical shock.

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

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

14 MeCA812i Operator’s Manual

Caution: Service shall be performed by the designated professional technician

MeCA812i Operator’s Manual 15

This page is intentionally left blank.

16 MeCA812i Operator’s Manual

MeCA812i Operator’s Manual 17

Caution: Medical technical equipment such as the MeCA812i must only be

18 MeCA812i Operator’s Manual

2. Description of control, display and symbols

Figure 2-1. Top Panel

LAN Connector AC Power Inlet

Figure 2-2. Rear Panel

Patient Cable SD Card Slot PS2

Figure 2-3. Right Panel

MeCA812i Operator’s Manual 19

Table 2-1. Display Description

10mm/mV 25mm/s 0.16Hz 100Hz 40Hz EMG Automatic

28/02/2007 AFS I II III 3 * 3R SD HR 060

No. Item Description

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

6 Muscle Filter Elimination of muscle artifact (only automatic mode)

7 Measurement Mode Indication of measurement mode

8 Date, Time Date and Time indication

- Manual Mode: Lead combination indication

10 Report Format Indication of report format

11 Heart Rate Indication of heart rate