About this Manual

P/N: 01.54.110286

MPN: 01.54.110286023

Release Date: December 2018

© Copyright EDAN INSTRUMENTS, INC. 2008-2018. All rights reserved.

Statement

This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User's operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.

EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.

Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.

The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.

EDAN holds the rights to modify, update, and ultimately explain this manual.

Product Information

Product Name: Electrocardiograph

Model: SE-601A, SE-601B, SE-601C

I
Responsibility of the Manufacturer

EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

persons authorized by EDAN, and

The electrical installation of the relevant room complies with national standards, and

The instrument is used in accordance with the instructions for use.

Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

II
 Table of Contents
Chapter 1 Safety Guidance ........................................................................................................... 1
1.1 Intended Use/Indications for Use ........................................................................................... 1
1.2 Warnings and Cautions ........................................................................................................... 1
1.2.1 Safety Warnings ............................................................................................................... 2
1.2.2 Li-ion Battery Care Warnings .......................................................................................... 5
1.2.3 General Cautions .............................................................................................................. 6
1.3 List of Symbols ....................................................................................................................... 7
Chapter 2 Introduction ................................................................................................................ 11
2.1 Top Panel .............................................................................................................................. 11
2.2 Keyboard and Keys .............................................................................................................. 12
2.3 Rear Panel ............................................................................................................................. 14
2.4 Right Panel ........................................................................................................................... 14
2.5 Bottom Panel ........................................................................................................................ 15
2.6 Features ................................................................................................................................. 16
Chapter 3 Operation Preparations ............................................................................................. 18
3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes ............................. 18
3.1.1 Connecting the Patient Cable to the Electrocardiograph ............................................... 18
3.1.2 Connecting the Patient Cable to Electrodes ................................................................... 19
3.2 Preparing the Patient ............................................................................................................. 19
3.2.1 Instructing the Patient .................................................................................................... 19
3.2.2 Cleaning the Skin ........................................................................................................... 20
3.3 Attaching Electrodes to the Patient ....................................................................................... 20
3.3.1 Electrode Placement ....................................................................................................... 21
3.3.2 Attaching the Reusable Electrodes ................................................................................. 22
3.3.3 Attaching the Disposable Electrodes .............................................................................. 23
3.4 Inspection Before Power-On ................................................................................................ 24
3.5 Turning On/Off the Electrocardiograph................................................................................ 25
3.6 Loading/Replacing Recorder Paper ...................................................................................... 26
Chapter 4 Basic Operation Guidance ........................................................................................ 29
4.1 Basic Operation..................................................................................................................... 29
4.2 About the Main Screen ......................................................................................................... 30
4.3 Work Mode Description ....................................................................................................... 31
Chapter 5 Entering Patient Information ................................................................................... 32
5.1 Entering Patient Information Manually ................................................................................ 32
5.2 Entering Patient Information by Using a Reader (Configurable) ......................................... 32

III
 5.3 Entering Patient Information by Acquiring Orders .............................................................. 32
Chapter 6 Printing ECG Reports ............................................................................................... 33

Chapter 7 Transmitting ECG Data............................................................................................. 34

7.1 Transmitting ECG Data in DAT Format Through Serial Cable ........................................... 35
7.2 Transmitting ECG Data Through Network .......................................................................... 35
7.2.1 Transmitting ECG Data in DAT Format ........................................................................ 35
7.2.2 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format ............................... 36
Chapter 8 Managing Orders ....................................................................................................... 37

Chapter 9 Managing Files ........................................................................................................... 39

Chapter 10 System Setup............................................................................................................. 42

10.1 Work Mode Setup ............................................................................................................... 42
10.2 Filter Setup ......................................................................................................................... 42
10.3 Record Info Setup ............................................................................................................... 43
10.3.1 Setup 1.......................................................................................................................... 43
10.3.2 Setup 2.......................................................................................................................... 44
10.4 Patient Information Setup ................................................................................................... 45
10.5 Transmission Setup ............................................................................................................. 46
10.5.1 Basic Setup ................................................................................................................... 46
10.5.2 WIFI Setup (Configurable)* ........................................................................................ 47
10.6 Lead Setup .......................................................................................................................... 47
10.7 Display&Sound Setup ........................................................................................................ 48
10.8 Date&Time Setup ............................................................................................................... 48
10.9 File Setup ............................................................................................................................ 49
10.10 System Maintenance Setup ............................................................................................... 49
10.11 Other Setup ....................................................................................................................... 50
Chapter 11 Error Messages ......................................................................................................... 51

Chapter 12 FAQ ........................................................................................................................... 52

Chapter 13 Cleaning, Care and Maintenance ........................................................................... 56

13.1 General Points..................................................................................................................... 56
13.2 Cleaning .............................................................................................................................. 56
13.3 Disinfection ........................................................................................................................ 57
13.4 Care and Maintenance ........................................................................................................ 58
13.4.1 Recharge and Replacement of Battery ......................................................................... 58
13.4.2 Recorder Paper ............................................................................................................. 60
13.4.3 Visual inspection .......................................................................................................... 61

IV
 13.4.4 Maintenance of the Main Unit and the Patient Cable .................................................. 61
Chapter 14 Accessories ................................................................................................................ 64
14.1 Standard Accessories .......................................................................................................... 64
14.2 Optional Accessories .......................................................................................................... 64
Chapter 15 Warranty & Service ................................................................................................. 66
15.1 Warranty ............................................................................................................................. 66
15.2 Contact information ............................................................................................................ 66
Appendix 1 Technical Specifications .......................................................................................... 67
A1.1 Safety Specifications ......................................................................................................... 67
A1.2 Environment Specifications ............................................................................................... 68
A1.3 Physical Specifications ...................................................................................................... 68
A1.4 Power Supply Specifications ............................................................................................. 68
A1.5 Performance Specifications ............................................................................................... 69
Appendix 2 EMC Information .................................................................................................... 72

Appendix 3 Abbreviation ............................................................................................................. 79

V
SE-601 Series Electrocardiograph User Manual Safety Guidance

Chapter 1 Safety Guidance

This chapter provides important safety information related to the use of SE-601 series
electrocardiograph.

1.1 Intended Use/Indications for Use

The intended use of SE-601 series electrocardiograph (hereinafter called SE-601 series) is to
acquire resting ECG signals from adult and pediatric patients through body surface ECG
electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities
by doctors and trained healthcare professionals. The cardiogram recorded by the
electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted
ECG with measurements and interpretive statements is offered to clinicians on an advisory basis
only.
SE-601 series is mainly used in ECG outpatient department, PE department, emergency
department and inpatient department of hospitals or healthcare facilities.

WARNING
1. This equipment is not designed for intracardiac use or direct cardiac application.

2. This equipment is not intended for home use.

3. This equipment is not intended for treatment or monitoring.

4. This equipment is intended for use on adult and pediatric patients only.

5. The results given by the equipment should be examined based on the overall clinical
condition of the patient, and they can not substitute for regular checking.

1.2 Warnings and Cautions

In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused
by improper operation, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

1.2.1 Safety Warnings

WARNING
1. The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.

2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell. Otherwise, safety
hazards may happen.

3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of

flammable anesthetic mixtures with oxygen or other flammable agents.

4. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.

5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, electrical
shock or other injuries may happen to the patient or operator.

6. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by an internal li-ion rechargeable battery.

7. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.

8. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection can not be guaranteed.
The electrocardiograph has been safety tested with the recommended accessories,
peripherals, and leads, and no hazard is found when the electrocardiograph is
operated with cardiac pacemakers or other stimulators.

9. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.

10. Make sure that all electrodes are connected to the patient correctly before operation.

11. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

WARNING
12. Disposable electrodes must be used during defibrillation.

13. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.

14. The disposable electrodes can only be used for one time.

15. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.

16. Do not touch accessible parts of electrical equipment and the patient simultaneously.

17. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.

18. If WIFI technology is used, in order to maintain compliance with the FCC RF
exposure guidelines, WIFI should be installed and operated with a minimum distance
of 20cm between the radiator and the human body. There should be no shield in or
around the room where WIFI is used.

19. Fix attention on the examination to avoid missing important ECG waves.

20. SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.

21. SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.

22. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

WARNING
23. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).

24. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.

25. Multiple portable socket-outlets shall not be placed on the floor.

26. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it's specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.

27. Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configuration shall comply with the valid version of the standard IEC/EN 60601-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.

28. Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph makes a medical system. In that case,
additional safety measures should be taken during installation of the system, and the
system shall provide:

a) Within the patient environment, a level of safety comparable to that provided by

medical electrical equipment complying with IEC/EN 60601-1, and

b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.

29. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.

30. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

WARNING
31. The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all the equipment is connected to the potential
equalization terminal.
32. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
33. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the electrocardiograph in a location where the operator can easily access
the disconnection device.
34. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC Information.
35. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix 2 EMC Information.
36. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
37. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.

1.2.2 Li-ion Battery Care Warnings

WARNING
1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification as manufacturer configuration should be used.
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4. Do not heat or splash the battery or throw it into fire or water.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

WARNING
5. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
6. When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leakage liquid, cleanse it with clean water at once.
If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with
clean water first and go to see a doctor immediately.
7. Properly dispose of or recycle the depleted battery according to local regulations.
8. Only when the device is off can the battery be installed or removed.
9. Remove the battery from the electrocardiograph when the electrocardiograph isn't
used for a long time.
10. If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent overdischarge.

1.2.3 General Cautions

CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.

2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.

3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.

4. Ruptured fuse must only be replaced with that of the same type and rating as the
original.

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SE-601 Series Electrocardiograph User Manual Safety Guidance

CAUTION
5. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.

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

1.3 List of Symbols

No. Symbol Description

1 External input/output

2 DEFIBRILLATION-PROOF TYPE CF APPLIED PART

3 Caution

4 Operating instructions

5 Equipotential grounding

6 Patient Cable Socket

7 USB socket

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SE-601 Series Electrocardiograph User Manual Safety Guidance

8 Net port

9 Alternating Current

10 Battery check

11 Battery recharging indicator

12 Delete key

13 Enter key

14 Esc key

15 Space key/Feed paper key

16 Shift key

17 Fn key

18 Power On/Off key

19 1mV/COPY key

20 MODE key

21 RESET key

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SE-601 Series Electrocardiograph User Manual Safety Guidance

22 PRINT/STOP key

23 Tab paper key

24 Gender key

25 Age Group key

26 General symbol for recovery/recyclable

27 Part Number

28 SERIAL NUMBER

29 Date of manufacture

30 MANUFACTURER

AUTHORISED REPRESENTATIVE IN THE EUROPEAN

31
COMMUNITY

32 CE marking

Caution: Federal (U.S.) law restricts this device to sale by

33
or on the order of a physician.

34 Disposal method

Refer to User Manual

35
(Background: Blue; Symbol: White)

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SE-601 Series Electrocardiograph User Manual Safety Guidance

Warning
36
(Background: Yellow; Symbol&Outline: Black)

37* Non- ionizing electromagnetic radiation

Contains FCC ID: Federal Communications Commission:

38*
YOPGS2011MIZ Contains FCC ID: YOPGS2011MIZ

Conforms to AAMI Std. 60601-1, IEC Std. 60601-2-25

39 Certified to CSA Std. C22.2 No 60601-1,CSA Std. C22.2
No 60601-2-25

NOTE:

1. 37*/38*: Apply to devices with wireless functions.

2. The user manual is printed in black and white.

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SE-601 Series Electrocardiograph User Manual Introduction

Chapter 2 Introduction

SE-601 series electrocardiograph has three models: SE-601A, SE-601B and SE-601C.

SE-601A adopts 3.5" single color LCD screen; SE-601B adopts 5.6"/5.7" multicolor TFT LCD
screen; SE-601C adopts 5.6"/5.7" multicolor TFT LCD touch screen.

Configuration: main unit, power cord, patient cable, chest electrodes, limb electrodes,
disposable electrodes, clip/snap/banana socket adaptors, thermal recorder paper,
fuses and battery.

NOTE: The pictures and windows in this manual are for reference only.

2.1 Top Panel

Recorder
LCD Screen

Indicators

Keyboard

Figure 2-2 Top panel (SE-601B/C)

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SE-601 Series Electrocardiograph User Manual Introduction

2.2 Keyboard and Keys

B

C
P D
O
N E

M F

H G
L K J I
Figure 2-3 Keyboard

Name Explanation

A Indicator It indicates the working state.

Press to select menu functions on the screen.

Press F1, F2, F3, F4 to move the cursor.

B Function Key Press Shift + F1/F2 to turn pages on the Order Manager screen and the
File Manager screen.
Press Shift + F3/F4 to slide the scroll bar on the Order Manager screen.

Press to quickly select the gender for the patient when Gender is
C Gender Key
selected in the Patient Information Setup window.

Press to quickly select the age group on the main screen when you set
D Age Group Key
Age to Age Group in the Patient Information Setup window.

E Backspace Key Press to delete characters.

F Enter Press to confirm operation.

Press Shift + Tab to move the cursor backward.

Press Shift and a number key to input the special character in the top
G Shift right corner of the key.

If Caps Lock is set to Off, pressing Shift + P can type a capital P.

If Caps Lock is set to On, pressing Shift + P can type a lowercase p.

Press Fn and a letter key to type special characters.

H Fn
Pressing Fn + a can type è.

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SE-601 Series Electrocardiograph User Manual Introduction

Press to start or stop printing reports

I PRINT/STOP Pressing Shift + PRINT/STOP can quickly enable or disable the print out
function in the auto or rhythm mode.

In the manual mode, pressing the 1mV/COPY key can insert a 1mV
calibration mark during the printing course.
J 1mV/COPY
In the auto or rhythm mode, pressing the 1mV/COPY key can print the
ECG report which was printed out last time.

A large polarization voltage may cause baseline drift. On the main

K RESET screen, pressing RESET can decrease the polarization voltage and draw
the baseline to zero quickly.

Press to select a working mode among the auto, manual, rhythm and
R-R analysis modes.
L MODE NOTE: Only if more than one working mode is selected in the Work
Mode Setup window, can the working mode be selected by
pressing the MODE key when the main screen is displayed.

Press to add a space between typed characters or select/deselect a

checkbox.

Press to feed paper:

Space/Feed
M If Paper Marker is set to Yes, pressing Tab can advance the recorder
paper
paper to the next black marker; if Paper Marker is set to No, pressing
Tab can advance the paper for 2.5cm. Pressing Tab again can stop
advancing the paper.

Press to move the cursor:

Pressing Tab can move the cursor forward, and pressing Shift + Tab can
N Tab move the cursor backward.

In the manual mode or on the previewing screen, press this key to switch
the lead groups.

O Esc Press to cancel operation

P Power On/Off Power-on/Power-off

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SE-601 Series Electrocardiograph User Manual Introduction

2.3 Rear Panel

Potential Equalization Conductor

Handle Mains Supply Socket

Figure 2-4 SE-601A/B/C Rear Panel

2.4 Right Panel

Patient Cable Socket USB Socket 1 USB Socket 2

Serial Port 1 Net port External Input / Output Socket

Figure 2-5 SE-601A/B/C Right Panel

Name Explanation

A Patient Cable Socket Connecting to the patient cable

B Serial Port 1 Connecting to a PC

C USB Socket 1 Standard USB socket, connecting to a PC

Standard USB socket, connecting to a U disk, a

D USB Socket 2 bar code reader or a USB printer recommended by
the manufacturer

E Net port Standard net port, connecting to a PC

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SE-601 Series Electrocardiograph User Manual Introduction

F External Input / Output Socket Connecting to the external signal device

WARNING
The isolated intensity of serial port 1 is 1500V AC and the maximum voltage applied
should not exceed +15V DC.

CAUTION
Only the USB equipment recommended by the manufacturer can be connected to the
USB interface.

2.5 Bottom Panel

B
D

Figure 2-6 SE-601A/B/C Bottom Panel

Name Explanation

Path for sound from speaker (only configurable for

A Speaker Hole
SE-601B/C)

B Battery Compartment Compartment for battery

C Heat Emission Hole Path for internal heat emission

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SE-601 Series Electrocardiograph User Manual Introduction

D Label Position for product information label

E Fuse The specification is: T3.15AH250V, φ5×20mm

WARNING
1. Improper operation may cause the battery to be hot, ignited or exploded, and it may
lead to the decrease of the battery capacity. Therefore, it is necessary to read the
user manual carefully and pay more attention to warning messages.

WARNING
2. When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leakage liquid, cleanse it with clean water at once.
If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with
clean water first and go to see a doctor immediately.

3. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification must be used.

4. Only when the device is off can the battery be installed or removed.

NOTE: If the battery has not been used for two months or more, you should recharge it
before using it again.

2) Fuse

There are two fuses of the same specification installed on the bottom of the main unit.

WARNING
Ruptured fuses must only be replaced with those of the same type and rating as the
original.

2.6 Features

♦ Supporting AC and DC power supply modes, internal rechargeable li-ion battery with
professional battery powered circuit, battery management and protection systems
♦ Supporting multi-language
♦ Full alphanumeric keyboard (SE-601C is also configured with touch screen.)
♦ ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves
are displayed and recorded simultaneously
♦ Correct detection for failure electrodes

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SE-601 Series Electrocardiograph User Manual Introduction

♦ Convenient operation of recording by pressing the PRINT/STOP key with high

efficiency
♦ High resolution thermal recorder, recording frequency response ≤150Hz
♦ Supporting external USB printer
♦ Supporting accurate digital filter to decrease the polarization voltage and other
interferences
♦ Supporting rolled and folded paper recorded with high resolution waveforms,
calibration mark, gain, speed and filter
♦ The auto, manual, rhythm and R-R analysis modes can be chosen freely
♦ Supporting order function (only configurable for SE-601B/C)
♦ Supporting bar code reader
♦ Supporting ECG waves displaying with grid
♦ Convenient operation of system setup and file management
♦ Multiple file formats: DAT, PDF and configurable formats (SCP/FDA-XML/DICOM)
♦ Supporting real-time sampling, pre-sampling, period sampling and arrhythmia
triggering sampling

♦ Supporting high capacity data storage, transferring files by USB disk

♦ Measurement function and interpretation function

♦ LCD backlight and the device can be turned off automatically according to the set time

♦ ECG data can be transmitted to the Data Management Software through the serial cable,
net cable or WIFI (configurable)

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SE-601 Series Electrocardiograph User Manual Operation Preparations

Chapter 3 Operation Preparations

WARNING
Before use, the equipment, patient cable and electrodes should be checked. Replace
them if there is any evident defectiveness or aging which may impair the safety or the
performance, and make sure that the equipment is in proper working condition.

3.1 Connecting the Patient Cable to the Electrocardiograph

and Electrodes

WARNING
The performance and electric shock protection can be guaranteed only if the original
patient cable and electrodes of the manufacturer are used.

The patient cable includes the main cable and lead wires which can be connected to electrodes.

3.1.1 Connecting the Patient Cable to the Electrocardiograph

Connect the patient cable to the patient cable socket on the right side of the main unit, and then
secure them with two screws.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

3.1.2 Connecting the Patient Cable to Electrodes

Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the
reusable electrodes or the clip/snap/banana socket adaptors. Firmly attach them.
The identifiers and color codes of electrode connectors used comply with IEC/EN requirements.
In order to avoid incorrect connection, the identifiers and color codes are specified in Table 3-1.
Moreover the equivalent codes according to American requirements are given in Table 3-1 too.

Table 3-1 Electrode Connectors and Their Identifiers and Color Codes

European American

Identifier Color Code Identifier Color Code

R Red RA White

L Yellow LA Black

N or RF Black RL Green

F Green LL Red

C1 White/Red V1 Brown/Red

C2 White/Yellow V2 Brown/Yellow

C3 White/Green V3 Brown/Green

C4 White/Brown V4 Brown/Blue

C5 White/Black V5 Brown/Orange

C6 White/Violet V6 Brown/Violet

3.2 Preparing the Patient

3.2.1 Instructing the Patient

Before attaching the electrodes, greet the patient and explain the procedure. Explaining the
procedure decreases the patient's anxiety. Reassure the patient that the procedure is painless.
Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area
where others can't see the patient. Make sure that the patient is comfortable. The more relaxed the
patient is, the less the ECG will be affected by noise.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

3.2.2 Cleaning the Skin

Thorough skin preparation is very important. The skin is a poor conductor of electricity and
frequently creates artifacts that distort the ECG signals. By performing methodical skin
preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline
drift, ensuring high-quality ECG waves. There is natural resistance on the skin surface due to dry,
dead epidermal cells, oils and dirt.
To Clean the Skin
Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.
Wash the area thoroughly with soap and water.
Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the
dead, dry skin cells and oils.

3.3 Attaching Electrodes to the Patient

Two kinds of electrode can be used, one is the reusable electrode (including chest electrodes and
limb electrodes), and the other is the disposable electrode.

WARNING
1. Make sure that all electrodes are connected to the patient correctly before operation.

2. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.

NOTE: The quality of ECG waveform will be affected by the contact resistance between
the patient and the electrode. In order to get a high-quality ECG, the
skin-electrode resistance must be minimized while connecting electrodes.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

3.3.1 Electrode Placement

The electrodes' positions on the body surface are shown in the following table and figure.

Standard 12-Lead Placement

European American
Electrode Placement
Label Label

C1 V1 Fourth intercostal space at the right border of the sternum

C2 V2 Fourth intercostal space at the left border of the sternum

C3 V3 Fifth rib between C2 and C4

C4 V4 Fifth intercostal space on the left midclavicular line

C5 V5 Left anterior axillary line at the horizontal level of C4

C6 V6 Left midaxillary line at the horizontal level of C4

L LA Left arm

R RA Right arm

F LL Left leg

N RL Right leg

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SE-601 Series Electrocardiograph User Manual Operation Preparations

NEHB Placement (for SE-601B/C)

European American
Electrode Placement
Label Label

Nst A1 Attachment point of the second rib to the right sternal edge

Nax A2 Fifth intercostal space on the left posterior axillary line

Nap V4 Left mid-clavicular line in the fifth intercostal space

R RA Right arm/Right deltoid

L LA Left arm/Left deltoid

N or RF RL Right leg/Upper leg as close to torso as possible

F LL Left leg/Upper leg as close to torso as possible

3.3.2 Attaching the Reusable Electrodes

Connecting to a Lead Wire

Reed

Clamp

Limb Electrode

Suction Bulb

Metal Cup Connecting to a Lead Wire

Chest Electrode

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SE-601 Series Electrocardiograph User Manual Operation Preparations

1) Ensure that the electrodes are clean;

2) Clean the electrode area which is a short distance above the ankle or the wrist with 75%
alcohol;
3) Daub the electrode area on the limb with gel evenly;
4) Place a small amount of gel on the metal part of the limb electrode clamp or on the brim
of the chest electrode’s metal cup;
5) Attach the electrodes in place.
When connecting the chest electrodes, place the electrode on the chest electrode site and
squeeze the suction bulb. Unclench it and the electrode is adsorbed on the chest;
NOTE: Long-time measurement with a strong negative pressure on the suction bulb
may cause reddening of the skin. When using the electrode on kids or patients
with delicate skin, squeeze the suction bulb lightly.

3.3.3 Attaching the Disposable Electrodes

CAUTION
The disposable electrodes can only be used for one time.

Disposable Electrode (clip style): Clip/Snap/Banana Socket Adaptor

Disposable Electrode Connection (Clip Style)

1) Align all lead wires of the patient cable to avoid twisting, and connect the clip/snap/banana
socket adaptors to the patient cable.
2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Clip the disposable electrodes with the clip/snap/banana socket adaptors.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

Snap/Banana Socket Adapters Disposable Electrode (Snap Style)

Disposable Electrode Connection (Snap Style)

1) Align all lead wires of the patient cable to avoid twisting, and cnnect Snap/Banana
Socket Adapters to connector of patient cable.
2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Connect Snap/Banana Socket Adapters to the disposable electrodes.

3.4 Inspection Before Power-On

In order to avoid safety hazards and get good ECG records, the following inspection procedures
are recommended before operation.

WARNING
The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained, and they should be familiar with the contents of this user manual
before operation.

1) Environment:

♦ Make sure that there is no electromagnetic interference source around the equipment,
especially large medical electrical equipment such as electrosurgical equipment,
radiological equipment, magnetic resonance imaging equipment etc. Turn off these
devices when necessary.
♦ Keep the examination room warm to avoid muscle tremor voltages in ECG signals
caused by cold.

2) Power Supply:

♦ If the mains supply is used, please check whether the power cord is connected to the
unit well. The grounded three-slot outlet should be used.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

♦ When the battery capacity is low, recharge the battery before use.

3) Patient Cable:

♦ Make sure that the patient cable is connected to the unit firmly, and keep it far away
from the power cord.
4) Electrodes:
♦ Make sure that all electrodes are connected to lead wires of the patient cable
correctly.
♦ Ensure that the chest electrodes do not contact with each other.
5) Patient:
♦ The patient should not come into contact with conducting objects such as earth, metal
parts etc.
♦ Ensure that the patient is warm and relaxed, and breathes calmly.

3.5 Turning On/Off the Electrocardiograph

WARNING
1. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by the battery.

2. Potential equalization conductor of the unit should be connected to the potential

equalization bus bar of the electrical installation when necessary.

The electrocardiograph can be powered by either the mains supply or the battery.

To turn on the Electrocardiograph:

♦ When operating on AC power

Make sure that the mains supply meets the requirements (refer to A1.4 Power Supply

Specifications) before power-on, and then press on the keyboard to turn on the
unit. The mains supply indicator ( ) is lit, and the logo will be displayed on the LCD
screen after self-test.
If the battery is weak when the mains supply is used, it will be recharged automatically
at the same time. Both the mains supply indicator ( ) and the battery recharging
indicator ( ) will be lit.
♦ When operating on battery power

Press on the keyboard to turn on the unit, and then the battery indicator ( )
will be lit and the battery symbol will be displayed. The logo will be displayed on the

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SE-601 Series Electrocardiograph User Manual Operation Preparations

LCD screen after self-test.

Because of the consumption during the storage and transport course, the battery
capacity may not be full. If the symbol and the hint information Battery Weak are
displayed, which means the battery capacity is low, please recharge the battery first.

CAUTION
1. If the electrocardiograph is turned off because of low battery capacity or unexpected
power failure, the settings or the current ECG report may not be saved.

2. The electrocardiograph cannot print an ECG report when the battery is weak.

3. The use of electrocardiograph accessories (such as barcode reader) will deplete

battery power at a faster rate. The battery will require more frequent charging if these
accessories are used with the electrocardiograph.

To turn off the Electrocardiograph:

♦ When operating on AC power

Hold down the key to display the hint System is shutting down… on the screen.
Then the device will be off a few seconds later. Remove the plug from the outlet.
♦ When operating on battery power

Hold down the key to display the hint System is shutting down… on the
screen. Then the device will be off a few seconds later.
NOTE:
1. When turning off the device, follow the above sequence strictly, or else there may be
something wrong on the screen.

2. Do not hold down the key when the device displays the hint information
System is shutting down… on the screen.

3.6 Loading/Replacing Recorder Paper

The recorder paper is the folded thermal paper.

NOTE:
1. The exit edge can help you tear the recorder paper.
2. If a sponge is placed in the paper tray, take it out before loading the recorder paper.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

CAUTION
Make sure that the recorder paper, is installed in the center of the recorder, and the paper
edge is parallel with the casing edge in the direction of advancing paper, in order to avoid
paper deviation or damage to the paper edge.

When the recorder paper runs out or is not loaded, the hint message No Paper will appear on the
screen. Then you should load or replace the recorder paper immediately.

Casing

Paper Tray

Casing Button

Loading/Replacing Process of Folded Paper:

Step 1) Step 3) Step 4)

1) Press the casing button downwards with one hand and pull the casing upwards with the
other hand to open the recorder.
2) Remove the remainder paper from the paper tray if necessary.
3) Take off the wrapper of the new folded paper, and then put it in the paper tray.

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SE-601 Series Electrocardiograph User Manual Operation Preparations

NOTE: If the paper with black markers is used, make sure that the markers are
on the bottom.
4) Pull the paper out with the grid side facing the thermal print head, and replace the casing
on the recorder.
5) Press down the recorder casing firmly.
6) Advance the recorder paper.
When the main screen is displayed, if Paper Marker is set to Beginning or End, you

can press to advance the recorder paper to the next black marker; if Paper

Marker is set to No, you can press to advance the paper for 2.5cm. Press

again to stop advancing the paper.

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SE-601 Series Electrocardiograph User Manual Basic Operation Guidance

Chapter 4 Basic Operation Guidance

The following sections provide an overview of the main operations and functions.
If the touch screen is configured, you can operate the electrocardiograph by touching the screen.

CAUTION
Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will
be damaged.

4.1 Basic Operation

Operation Keys

To select options on the bottom panel of the screen Corresponding functional keys

To move the cursor Tab; Shift + Tab; F3; F4

To erase the typed information Bksp

To input special characters Shift + numeric key

To switch between upper case and lower case Shift +letter key

To select or deselect an item Space

F1/F2 (SE-601B/C)
Switch between options
F3/F4 (SE-601A)

To confirm and entering a screen Enter

To cancel operation; return to the upper level ESC

Refresh all patient information except for the Gender,

Age Group, Exam.Room, Physician and Technician Shift + Bksp
information after you print an ECG report

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SE-601 Series Electrocardiograph User Manual Basic Operation Guidance

4.2 About the Main Screen

After the electrocardiograph is turned on, the main screen appears.

Figure 4-1 Main Screen1 (SE-601B/C)

Figure 4-3 SE-601B/C Main Screen2

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SE-601 Series Electrocardiograph User Manual Basic Operation Guidance

For the electrocardiograph configured with the touch screen, you can touch the displayed
information to modify corresponding settings.

NOTE:
1. The modification of filter, gain, or speed on the main screen is only effective for the
current patient.
2. When the leads are off, the lead names will be highlighted.
3. Work mode can be selected by pressing the MODE key when the main screen is
displayed.

4.3 Work Mode Description

There are four work modes in SE-601 series electrocardiograph.

AUTO: In the auto mode, the ECG data can be analyzed, saved, printed and
transmitted. The lead groups are switched automatically according to the
lead sequence during the printing course. After the ECG waves of one lead
group are printed within a certain time, the system switches to print ECG
waves of another lead group automatically. 1mV calibration marks will be
printed at the beginning of an ECG report.
MANU: In the manual mode, you can determine the lead group to be displayed and
printed. Pressing Tab can switch among the lead groups.
RHYT: In the rhythm mode, the ECG data can be saved and transmitted. You can
print 60s rhythm-lead ECG waveform of one lead in the Single Lead style
or 20s rhythm-lead ECG waveform of three leads in the Three Leads style.
R-R: In the R-R analysis mode, you can select a lead to print its R-R histogram,
R-R trend chart, 180s compressed ECG waveform and all the R-R interval
values.

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SE-601 Series Electrocardiograph User Manual Entering Patient Information

Chapter 5 Entering Patient Information

5.1 Entering Patient Information Manually

1. Configure the Patient Information Setup window. (Configurable)

2. Select Patient on the main screen1 to open the Patient Information window.

NOTE: The total number of supported characters may be fewer if special Latin characters
are entered.

5.2 Entering Patient Information by Using a Reader

(Configurable)
1. Configure the bar code
For more detailed information about configuring the bar code, please contact the
manufacturer or the local distributor.
2. Connect the bar code reader to USB socket 2 on the right panel of the electrocardiograph.
3. When the main screen is displayed, scan the patient's bar code with the bar code reader, and
then the patient information will appear in the corresponding box.
NOTE: Only the bar code reader recommended by the manufacturer can be used.

5.3 Entering Patient Information by Acquiring Orders

NOTE: To use the order function, the ECG data management software (DMS) of the
manufacturer must be installed in the PC.
Operation procedures are as follows:
1. Connect the electrocardiograph to the PC with Ethernet cable recommended by the
manufacturer.

2. Log into the DMS.

3. Set Server IP, Local IP, Gateway and Subnet Mask in the Transmission Setup window.

4. Select Order Acquired function in Setup-> Patient Info.

5. Open the Patient Information window.

6. Enter the patient ID manually in the ID textbox or connect a bar code reader, press Order,
and then the matched order will be loaded from the DMS and the order information will be
displayed in the corresponding textboxes.

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SE-601 Series Electrocardiograph User Manual Printing ECG Reports

Chapter 6 Printing ECG Reports

Select a work mode

Configure printing and system Press PRINT/STOP to stop

parameters if necessary sampling

MANU
Press PRINT/STOP to start mode
Manually switch lead group
sampling

In the auto and rhythm modes, pressing the 1mV/COPY key can print the ECG report which was
printed out last time. Pressing the PRINT/STOP key can stop printing the ECG report.

NOTE:
1. The working mode can not be changed during the printing course. Stop printing
reports before changing the working mode.
2. Within three seconds after returning to the main screen, if you press the PRINT/STOP
key to print an ECG report in the auto quick mode or the manual mode, the recorder
will not respond.
3. If Print Out is set to Off in the Record Info Setup1 window, the ECG report can be
saved and transmitted, but cannot be printed out by pressing the PRINT/STOP key in
the auto and rhythm modes.
4. In the R-R analysis mode, you can not set the speed. The constant speed is 25mm/s
and the printing speed is 5mm/s, because in the R-R analysis mode, the ECG wave
length is compressed to one fifth of the original wave length.
5. Within 10 seconds after returning to the main screen, pressing F2 can not display the
freezing screen.

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SE-601 Series Electrocardiograph User Manual Transmitting ECG Data

Chapter 7 Transmitting ECG Data

ECG data in DAT/PDF/SCP/FDA-XML/DICOM format can be transmitted to the PC. To
transmit ECG data in DAT format, the DMS of the manufacturer must be installed in the PC. To
transmit ECG data in PDF/SCP/FDA-XML/DICOM format, the FTP receiving software must be
installed in the PC.
NOTE: SE-601A can only transmit ECG data in DAT format.

CAUTION

It is forbidden to connect or disconnect a U disk or a USB printer during the transmission

course.

WARNING

This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received, including interference that may
cause undesired operation.

NOTE:
1. This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
2. Any changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.

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SE-601 Series Electrocardiograph User Manual Transmitting ECG Data

7.1 Transmitting ECG Data in DAT Format Through Serial

Cable

1. If the PC has RS232 socket, connect the PC RS232 socket to the electrocardiograph RS232
socket with an RS232 cable.

2. Set Auto Transmission to On and Transmission Mode to UART in the Transmission Setup
window.
3. Log into the DMS.
4. In the auto or rhythm mode, ECG data will be transmitted through the serial cable
automatically after an ECG report is printed out.

7.2 Transmitting ECG Data Through Network

7.2.1 Transmitting ECG Data in DAT Format

1. Log into the DMS.

2. Connect the electrocardiograph to the PC with an Ethernet cable recommended by the
manufacturer.
3. Configure the Transmission Setup window.
NOTE: For more information on configuring network settings, see your Network
Administrator.

For Ethernet Transmission:

1) Press Shift + F1 in the Transmission Setup window to open the Basic Setup window.
2) Set Auto Transmission to On and Transmission Mode to Wired.
3) Set the Server IP item to the IP of the PC, and FTP username and password to
EDANDAT.
For details, please refer to Section 10.5.1 "Basic Setup".
4) Press Enter to confirm, and then press Esc to return to the main screen.
For Wireless Network Transmission:
1) Press Shift + F1 in the Transmission Setup window to open the Basic Setup window.
2) Set Auto Transmission to On and Transmission Mode to Wireless.
3) Set the Server IP item to the IP of the PC.
For details, please refer to Section 10.5.1 "Basic Setup".
4) Press Shift + F2 in the Transmission Setup window to open the WIFI Setup window.
For details, please refer to Section 10.5.2 "WIFI Setup".

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SE-601 Series Electrocardiograph User Manual Transmitting ECG Data

5) Connect the wireless network.

4. Set File Format to DAT in the File Setup window.
5. In the auto or rhythm mode, ECG data will be transmitted through the network automatically
after an ECG report is printed out.

7.2.2 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format

NOTE: SCP/FDA-XML/DICOM function can be activated on the Advanced Setup

screen. For details, please contact the manufacturer or the local distributor.
1. Log into the FTP receiving software.
2. Connect the electrocardiograph to the PC with an Ethernet cable recommended by the
manufacturer.
3. Configure the Transmission Setup window.
1) Press Shift + F1 in the Transmission Setup window to open the Basic Setup window.
2) Set Auto Transmission to On and Transmission Mode to Wired or Wireless.
3) Set the Server IP item to the IP of the PC.
For details, please refer to Section 10.5.1 "Basic Setup".
4) Set the FTP User Name, FTP Password and FTP Path items.
a) The user name and the password you input in the FTP User Name and FTP
Password items must be available for FTP server.
b) The path you input in the FTP Path item must be the subdirectory of the path you
input in the FTP receiving software.
NOTE: For more information about FTP server, see your Network Administrator.
4. Set File Format to SCP/FDA-XML/PDF/DICOM in the File Setup window.
5. In the auto or rhythm mode, ECG data will be transmitted through the network automatically
after an ECG report is printed out.

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SE-601 Series Electrocardiograph User Manual Managing Orders

Chapter 8 Managing Orders

Figure 8-1 Order Manager Screen1 (SE-601B/C)

Figure 8-2 Order Manager Screen2 (SE-601B/C)

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SE-601 Series Electrocardiograph User Manual Managing Orders

NOTE:
1. The order function is only configurable for SE-601B/C.

2. To use the order function, the ECG data management software (DMS) of EDAN must
be installed in the PC.8.1 Loading Orders

Once the electrocardiograph is turned on, you can open the Order Manager screen by pressing
Patient if orders without examination exist on the Order Manager screen.
After you press Examine on the Order Manager screen to return to main screen1, you cannot
open the Order Manager screen by pressing Patient until you complete an order examination
next time.

To load order information:

1. On the electrocardiograph, configure the Order Setup screen.

2. Connect the electrocardiograph to the PC installed with the DMS by using an Ethernet cable
recommended by the manufacturer.
3. Set Server IP, Local IP, Gateway and Subnet Mask in the Transmission Setup window.
For details, please refer to Section 10.5 "Transmission Setup".
4. Select Load on the Order Manager screen to load orders from the DMS.
If Auto Refresh is enabled in Order Setup, the system will automatically refresh the order
information every time you enter the Order Manager screen.
NOTE: If orders are modified on the DMS, the corresponding orders existing on the
Order Manager screen will be refreshed after you load orders from the
software.

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SE-601 Series Electrocardiograph User Manual Managing Files

Chapter 9 Managing Files

Figure 9-1 File Manager Screen1

Figure 9-2 File Manager Screen2

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SE-601 Series Electrocardiograph User Manual Managing Files

Figure 9-3 File Manager Screen3

Export file path: ECGDATA\ECG-x\Export\ Export Date and Time

Import file path: ECGDATA\Import

CAUTION
1. Do not cut off the mains supply directly when no battery is installed in the device, or
else, the stored data may be lost.

2. When files are being printed, transmitted, deleted or exported, you can not turn off
the electrocardiograph.

3. It is forbidden to connect or disconnect a U disk or a USB printer during the

transmission course.

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SE-601 Series Electrocardiograph User Manual Managing Files

NOTE:
1. Please insert the U disk recommended by the manufacturer. Please set the format to
FAT or FAT32 when formatting the U disk.
2. X in the directory of ECGDATA\ECG-X\Export\Export Date and Time can be set in
the Device No. textbox in the Transmission Setup window.
3. If you select Delete After Trans. Or Export in the File Setup window, the files will be
deleted from the File Manager screen after they are exported.
4. Only the ECG files in DAT format produced by the electrocardiograph of the
manufacturer can be imported.
5. Rhythm data cannot be previewed.
6. On the previewing screen, you can press Tab to switch the lead groups.

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SE-601 Series Electrocardiograph User Manual System Setup

Chapter 10 System Setup

Select Setup on the main screen1 to display the System Setup screen.

10.1 Work Mode Setup

Default
Items Default
(Only in the U.S.)

Mode Options Auto, Manual, Rhythm Auto, Manual, Rhythm, R-R

Display Style 6×2 3×4+1R

Sampling Mode Real-time Sample Real-time Sample

Rhythm Style Three Leads Three Leads

Duration
60 min 60 min
(Periodic Sample)

Interval
1 min 1 min
(Periodic Sample)

Preview Off Off

Auto Arrhythmia Detection Off Off

10.2 Filter Setup

Default
Items Default
(Only in the U.S.)

AC filter On On

EMG filter Off Off

DFT filter 0.67Hz 0.67Hz

Lowpass filter 100Hz 100Hz

SE-601A: CMRR ≥ 121dB (when AC filter is ON)

SE-601B/C: CMRR ≥ 140dB (when AC filter is ON)

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SE-601 Series Electrocardiograph User Manual System Setup

NOTE:

1. AC frequency can be set to 50Hz or 60Hz on the Advanced Setup screen according
to local mains supply specifications.
2. Only when EMG Filter is set to Off, can the setting of Lowpass Filter be effective.
3. To pass the distortion test, the electrocardiograph has to be configured with the
highest bandwidth in filter settings. Otherwise, ECG signal may be distorted.

10.3 Record Info Setup

10.3.1 Setup 1

Default
Items Default
(Only in the U.S.)

Auto Record Style 6×2 3×4+1R

Manual Style 6 channels 6 channels

Rhythm Record Mode Save Paper Save Paper

Record Sequence Sequential Sequential

Record Length Medium (5s) Medium (5s)

Gain 10mm/mV 10mm/mV

AGC Off Off

Print Out On On

Paper Marker Beginning Beginning

Speed 25mm/s 25mm/s

Sample Time 10s 10s

Item Description

Record Device Choose from: Thermal, HP2010/1050/2000, HPM401/2015/2035,

HP1106/1020P, HP1106/1020P, HP4729/3638, HPM202D/1525/M403d,
HP3638/4729.

NOTE:

1. During the USB printing course, pressing the PRINT/STOP key again
can not stop printing ECG reports.

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SE-601 Series Electrocardiograph User Manual System Setup

2. USB printing is ineffective in the auto periodic sampling mode, auto

11~60s sampling mode, manual mode and R-R analysis mode.
3. Make sure that paper is installed in the USB printer before printing. Error
may occur if no paper is loaded in the USB Printer.
4. You should connect the corresponding USB printer to the
electrocardiograph.
5. Print Out configuration is effective only under the AUTO or RHYT mode.

WARNING

If the printer used is not the type listed above, additional safety measures (such as
applying an isolation transformer to supply the medical system) should be taken when the
safety of the medical system has not been evaluated. If in doubt, consult our technical
service department or your local distributor.

CAUTION
It is forbidden to connect or disconnect a U disk or a USB printer during the transmission
course.

10.3.2 Setup 2

Default
Items Default
(Only in the U.S.)

Measure / Analysis On On

Template / Position Marker /

Time Scale / Minnesota Off Off
Code / Device No.

Baseline Adjustment Horizontal Horizontal

RR Interval List Off Off

Grid of Thermal Report Off Off

Grid of USB Report On On

Prompt Confirmed By Confirmed By

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SE-601 Series Electrocardiograph User Manual System Setup

10.4 Patient Information Setup

Default
Items Default
(Only in the U.S.)

Gender / Pacemaker On On

First\Last Name / BP / Race

/ Height / Weight /
Medication / Room No. /
Off Off
Department / Physician /
Technician / Ref-Physician /
Exam. Room

ID Mode Auto Manual

ID Hint On On

Age Mode Age D.O.B

H/W Unit cm/kg inch/lb.

BP Unit mmHg mmHg

PatInfo Refreshed On On

Order Acquired Off Off

User-defined Cleared Cleared

Item Description

Patient Options Select the item displayed in the Patient Information window.
NOTE:
1. Pacemaker appears in the Patient Information window after it is
selected in the Patient Information Setup window. Set Pacemaker to
Yes in the Patient Information window, and the Pacemaker information
will be displayed on the report printed out.
2. Pacemaker is recommended to be set to No unless it is known that the
majority of the electrocardiograph usage will be on patients with
pacemakers.

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SE-601 Series Electrocardiograph User Manual System Setup

10.5 Transmission Setup

Default
Items Default
(Only in the U.S.)

Auto Transmission Off Off

Transmission Mode Wired Wired

FTP User Name / FTP

Cleared EDANDAT
Password/ FTP Path

Enable WIFI Disabled Disabled

Auto Get IP Off Off

10.5.1 Basic Setup

NOTE: To transmit ECG data, the DMS of the manufacturer or the FTP receiving
software must be installed in the PC.

Item Description

IP Addresses Set Server IP, Local IP, Gateway, Subnet Mask

For the cross-network transmission,

a) Set the first two sections of the Local IP item to the first two sections of
the IP of the PC.

b) Set the third section of the Local IP item to the network segment of the
electrocardiograph which depends on the configuration of Router.

c) The last section of the Local IP item can be set at random.

For the same network transmission,

a) Set the first three sections of the Local IP item to the first three sections
of the IP of the PC.

b) The last section of the Local IP item can be set at random, but it can't be
the same as the last section of the IP of the PC.
NOTE: If WIFI is enabled and Auto Get IP is selected in the WIFI Setup
window, IP addresses can be acquired automatically.

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SE-601 Series Electrocardiograph User Manual System Setup

10.5.2 WIFI Setup (Configurable)*

NOTE:
1. *Not available in Canada.
2. The WIFI transmission function is only available for the machine configured with the
WIFI module.

Item Description

Auto Get IP Select this item, addresses of Local IP, Gateway and Subnet Mask will be
acquired automatically after the wireless network is connected successfully.
NOTE:
1. Only if WIFI is disabled, can Auto Get IP option be available.
2. To use Auto Get IP, DHCP function needs to be enabled on the routing
end.

View MAC Address View the MAC address of the WIFI module.

10.6 Lead Setup

Default
Items Default
(Only in the U.S.)

Lead Sequence Standard Standard

Nehb Off Off

Rhythm Lead 1 II II

Rhythm Lead 2 V1 V1

Rhythm Lead 3 V5 V5

Item Description

Lead Choose from: Standard or Cabrera

Sequence Lead
Lead group 1 Lead group 2 Lead group 3 Lead group 4
Sequence

Standard І, II, III aVR, aVL, aVF V1, V2, V3 V4, V5, V6

Cabrera aVL, І, -aVR II, aVF, III V1, V2, V3 V4, V5, V6

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SE-601 Series Electrocardiograph User Manual System Setup

Nehb Choose from: On or Off.

Lead Sequence: I, II, III, ND, NA, NI
NOTE: If you set Nehb to On, the working mode is fixed to be manual.

10.7 Display&Sound Setup

Default
Items Default
(Only in the U.S.)

Brightness 10 10

Key Volume Medium Medium

Hint Volume Medium Medium

QRS Volume Off Off

Notify Volume Medium Medium

Display Colors Option 1 Option 1

Antialiasing Off Off

Grid On On

Item Description

Antialiasing Reserved for future use.

10.8 Date&Time Setup

NOTE: Please set DATE&TIME correctly when it's the first time you use the
electrocardiograph.
Default
Items Default
(Only in the U.S.)

Date Mode DD-MM-YYYY DD-MM-YYYY

Time Mode 24 Hours 24 Hours

Power Off/ LCD Off Cleared Cleared

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SE-601 Series Electrocardiograph User Manual System Setup

10.9 File Setup

Default
Items Default
(Only in the U.S.)

Auto Save To ECG To ECG

File Format DAT PDF

Delete After Trans. Or

Off Off
Export

Replace When Memory Full Off Off

Item Description

Auto Save Choose from: Off, To ECG or To External Memory

Select Off, ECG data will not be saved.
Select To ECG, ECG data in the auto or rhythm mode will be saved in the
ECG automatically.
Select To External Memory, ECG data in the auto or rhythm mode will be
automatically saved to the directory of
ECGDATA\ECG-X\Store\Examination Date of the U disk after an ECG
report is printed out.
NOTE:
1. Please insert the U disk recommended by the manufacturer. Please set
the format to FAT or FAT32 when formatting the U disk.
2. X in the directory of ECGDATA\ECG-X\Store\Examination Date can be
set in the Device No. textbox in the Transmission Setup window.

10.10 System Maintenance Setup

Default
Items Default
(Only in the U.S.)

System Password Cleared Cleared

Item Description

System Password If you set the system password in the System Maintenance window, you
need enter the password before opening the System Setup screen.

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SE-601 Series Electrocardiograph User Manual System Setup

10.11 Other Setup

Default
Items Default
(Only in the U.S.)

External Input Off Off

External Output Off Off

Caps Lock Off Off

Institution Cleared Cleared

Language English English

Item Description

External Output The external output socket is equipped in the electrocardiograph, through
which the electrocardiograph can send rhythm lead signals to the external
equipment.
Choose from: Off, Standard or Triggered
Select Standard, the electrocardiograph sends ECG signals of rhythm lead 1.
Select Triggered, the electrocardiograph sends pulses with the height of 5V
and the width of 45ms, based on the data of rhythm lead 1.

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SE-601 Series Electrocardiograph User Manual Error Messages

Chapter 11 Error Messages

Error Messages and the corresponding causes provided by the electrocardiograph are listed in
Table 11-1.
Table 11-1 Error Messages and Causes for Resting ECG
Error Messages Causes

Electrodes fall off the patient or the patient cable falls off the unit, or
Lead off
a high polarization voltage occurs.
Battery Weak The battery is weak.

No Paper Recorder paper runs out or is not loaded.

Testing The ECG data is being sampled periodically.

When Paper Marker is set to Yes, the electrocardiograph advances

the recorder paper to the next black marker. If it advances the paper
Paper Error
for 300mm and can not find the next black marker, the hint Paper
Error is displayed.
Sampling/Analyzing/R
ECG signals are being sampled / analyzed / recorded.
ecording
The self-study process of arrhythmia arithmetic in the Trigger Sample
Learning
mode
The examining process of arrhythmia data in the Trigger Sample
Detecting
mode
ECG data is being transmitted from the electrocardiograph to the PC
Transmitting
through the net or serial cable in the auto or rhythm mode.

Loading Order… Orders are being loaded to the electrocardiograph.

Memory Full The amount of files on the File Manager screen reaches 800.

Module Error There is something wrong with the signal sample module.

DEMO The system is in the demonstration mode.

Overload The direct current offset voltage on an electrode is too high.

U Disk / USB Printer / A U disk, a USB printer or a bar code reader is connected to the USB
USB Scanner interface.

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SE-601 Series Electrocardiograph User Manual FAQ

Chapter 12 FAQ
1. Operating Problems

Q1: I was trying to select a file from the file list on the File Manager screen, but the file was in
the middle of the long list. Is there any way to make the selection faster?
A1: Actually, the system provides a method for fast moving: pressing Shift + F1 or F2 can move
the cursor up or down in the file list very fast.

Q2: I was just about to input the age when I suddenly realized that I had entered the Name
textbox unintentionally, can I just go back without pressing Tab for a whole circle?
A2: As a matter of fact, the system does take such unintentionalities into consideration by
providing Shift + Tab as the way back, as the Microsoft Windows operating system does.

Q3: I want to save the ECG data without printing, could it be possible?
A3: Yes, you can set Print Out to Off in the Record Info Setup1 window. Or, in the auto or
rhythm mode, you can directly press Shift + PRINT/STOP to enable or disable the print out
function. The ECG data will be collected and saved without printing. In the same way, if the
transmission settings are configured, the ECG data could be transmitted to the PC without
printing.

Q4: I want to input the patients' phone number in the Patient Information window, but there is
no such item. Can I add it manually?
A4: Yes, there is a user-defined item for entering patient information. It works in this way: first
input the name of the item in the User-defined textbox in the Patient Information Setup
window, e.g. Tel. Then return to the main screen1, and open the Patient Information window,
the Tel item will be displayed in this window. Now it's possible to input the phone number of
the patient in the Tel textbox.

Q5: Memory Full is displayed on the main screen; Or, the hint Memory full! Replace the earliest
file? pops up every time when I save an ECG report to the electrocardiograph. What am I
supposed to do?
A5: Memory Full is used to remind you that the amount of stored file reaches the upper limit.
The display of the pop-up hint Memory full! Replace the earliest file? is related to the
settings of the File Setup window.
Select Off from the Replace When Memory Full list box, when the amount of stored files

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SE-601 Series Electrocardiograph User Manual FAQ

reaches the upper limit and you save an ECG report to the electrocardiograph, the hint
Memory full! Replace the earliest file? pops up.
Select On from the Replace When Memory Full list box, when the amount of stored files
reaches the upper limit and you save an ECG report to the electrocardiograph, the hint
Memory full! Replace the earliest file? does not pop up.
You can deal with the hint as follows:
1) You can just delete several stored files from the electrocardiograph to ensure the amount
of stored file not to reach the upper limit.
2) When Memory Full is displayed on the main screen, you can set Auto Save to To
External Memory to save the added ECG reports. However, the amount of stored files in
the electrocardiograph still reaches the upper limit.

2. Printing Problems

Q1: I was encountered with paper-jam, what was I supposed to do?

A1: If it happened for the first time, it might be the result of an inappropriate placement of the
paper. In this case, please open the recorder casing, pull the paper out of the paper tray, tear
the pages with rumples, and then put the paper in the paper tray again, adjust the position of
the paper carefully and close the casing.
If it happened several times, it might have something to do with your configuration. If Paper Maker is
set to Beginning or End and you frequently press PRINT/STOP to stop the printing in the auto or
rhythm mode, the rolling back recorder will cause the paper-jam. In this case, you should set Paper
Maker to No in the Recorder Setup window.
If the problem still exists, please contact the manufacturer or the local distributor for further
disposal.

Q2: The hint Paper Error is displayed on the screen, what should I do?
A2: It might be the result of unsuccessful detection of the black markers, first open the recorder
casing so as to clear the error information, and then check whether the black marker is on the
bottom of the paper. Reload the paper in the paper tray. If it doesn't work, change the paper.
If the problem still exists, please contact the manufacturer or the local distributor for further
disposal.

Q3: The hint No Paper is displayed on the screen, what should I do?
A3: Check whether the paper runs out, or the black marker is just facing the black marker
detection window on the thermal printing head, as the following figure shows.

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SE-601 Series Electrocardiograph User Manual FAQ

Reload the paper in the paper tray, close the recorder casing firmly. If the problem still
exists, please contact the manufacturer or the local distributor for further disposal.

Q4: I want to print the hospital name in the report, but I can't find the place to enter it, where is
it?
A4: Please open the Other Setup window, and move the cursor to the Institution textbox, and
then input the hospital name. The content you input in this textbox will be printed in the
report. For details, please refer to Section 10.12, "Other Setup".

Q5: I pressed the PRINT/STOP key, but the ECG didn't start printing, what's wrong with it?
A5: The system will not respond to the PRINT/STOP key during the first 3s after you return to the main
screen. Therefore, you have to wait for a few seconds, and then you are able to start the printing by
pressing the PRINT/STOP key.
If you wait for a few seconds, but you still unable to start the printing by pressing the PRINT/STOP key,
please check whether there is any error information displayed on the screen.

If the hint No Paper or Paper Error is displayed on the screen, please deal with it according
to the above-mentioned measures.
If the hint Transmitting… is displayed on the screen, which means that the ECG is
transmitting the data to the PC, please wait a few seconds. You can start the printing after
the data is transmitted.
If the problem still exists, please contact the manufacturer or the local distributor for further
disposal.

Q6: I set the filter, speed and gain on the main screen1, but these settings were changed after
printing.
A6: The filter, speed and gain which are set on the main screen1 will not be saved, and they are
changed when you exit the main screen1 or after printing. If you want to save these settings,
please set them in the Record Info Setup window and the Filter Setup window.

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SE-601 Series Electrocardiograph User Manual FAQ

3. Transmitting Problems

Q1: The ECG doesn't respond to any keys after a long time of transmission. It transmits nothing
for there is no new data appearing on the screen of the PC software. What should I do?
A1: Some error may occur during the transmission course, for example, the connection between
the ECG and the net cable may loosen. In this case, please connect the net cable well. If it
doesn't work, please restart the ECG.
If the problem still exists, please contact the manufacturer or the local distributor for further
disposal.

4. Main Unit Problems

Q1: After power-on, the ECG stays on the logo screen and doesn't open the main screen. I have
restarted the machine several times, but there is no better change.
A1: The reason for this problem might be: there is a key pressed down, without springing up.
Find that key, and make it spring up, the problem should be solved.

Q2: I was doing the examination when the machine suddenly gave out a sound and displayed the
hint Lead Off. What should I do?
A2: The corresponding electrodes are not connected well. Please find out which lead is off by
checking the Lead Name area on the main screen (please refer to Section 4.3.1, "About the
Main Screen"). The lead whose name is highlighted is off. Please check whether the
corresponding electrode of the lead is connected to the patient skin well, and then make sure
that the patient cable socket is connected to the patient cable firmly.
If none of the above-mentioned measures takes effect, please contact the manufacturer or
the local distributor for further disposal.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

Chapter 13 Cleaning, Care and Maintenance

Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect
your equipment. Warranty does not cover damage caused by using unapproved substances or
methods.
Edan Instruments has validated the cleaning and disinfection instructions provided in this User
Manual. It is the responsibility of the healthcare professional to ensure that the instructions are
followed so as to ensure adequate cleaning and disinfection.

13.1 General Points

Keep your electrocardiograph and accessories free of dust and dirt. To prevent the device from
damage, please follow the instructions:
 Use only the recommended cleaning agents and disinfectants listed in this manual. Others
may cause damage (not covered by warranty), reduce product lifetime or cause safety
hazards.
 Always dilute according to the manufacturer's instructions.
 Unless otherwise specified, do not immerse any part of the equipment or any accessories in
liquid.
 Do not pour liquid onto the equipment.
 Do not allow liquid to enter the case.
 Never use abrasive material (such as steel wool or silver polish).
 Inspect the electrocardiograph and reusable accessories after they are cleaned and
disinfected.

CAUTION
1. If you spill liquid on the equipment or accessories, or they are accidentally immersed
in liquid, contact your service personnel or EDAN service engineer.

2. The equipment is chemically resistant to most cleaning agents, disinfectants and

non-caustic detergents used in hospital, but cleaning agents or disinfectants that are
not listed in this manual are not recommended. For example, didecyl dimethyl
ammonium bromide, which contains quaternary ammonium salt, may corrode the
equipment and accessories.

13.2 Cleaning

If the equipment or accessory has been in contact with the patient, then cleaning and disinfection

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

is required after each use.

The validated cleaning agents for cleaning the electrocardiograph and reusable accessories are:
 Mild near neutral detergent
 Ethanol (75%)
 Isopropanol (70%)
Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper
towel.

WARNING
Turn off the power before cleaning. The mains supply must be switched off if it is used.

1. Switch off the main unit and disconnect it from the power cord.
2. Wipe the exterior surface of the electrocardiograph, patient cable, and reusable electrodes
(suction bulbs of chest electrodes and the clamps of limb electrodes) using a soft cloth
dampened with the cleaning solution until no visible contaminants remain.
3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after
cleaning until no visible cleaning agent remains.
4. Dry the electrocardiograph, patient cable, and reusable electrodes in a ventilated and cool
place.

CAUTION
Any remainder of cleaning solution should be removed from the main unit and the patient
cable after cleaning.

13.3 Disinfection

To avoid permanent damage to the equipment, it is recommended that disinfection is performed

only when it is considered as necessary according to your hospital' regulations.
Clean the equipment and reusable accessories before they are disinfected. The validated
disinfectants for disinfecting the electrocardiograph and reusable accessories are:
 Ethanol (75%)
 Isopropanol (70%)
If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required
to be used for the disinfection step.

CAUTION
1. Do not use high-temperature, high-pressure vapour or ionizing radiation as
disinfection methods.

2. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

3. Clean and disinfect reusable electrodes after each use.

WARNING
Turn off the power before disinfection. The mains supply must be switched off if it is used.

1. Switch off the main unit and disconnect it from the power cord.
2. Wipe the exterior surface of the electrocardiograph, patient cable, and reusable electrodes
(suction bulbs of chest electrodes and the clamps of limb electrodes) using a soft cloth
dampened with the disinfectant solution.
3. Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.
4. Dry the electrocardiograph, patient cable, and reusable electrodes for at least 30 minutes in a
ventilated and cool place.

13.4 Care and Maintenance

CAUTION
Operate the cardiograph, charge the battery, and store the battery at a temperature of
40℃ (104ºF) or lower. Exposure to higher temperature may reduce battery life, damage
the battery, and degrade overall cardiograph performance.

13.4.1 Recharge and Replacement of Battery

1) Capacity Identification
The battery capacity can be identified according to the battery symbol in the top right corner
of the LCD screen.

: Full capacity;

: 2/3 capacity;

: 1/3 capacity;

: Low capacity

2) Recharge
SE-601 series electrocardiograph is equipped with the recharge control circuit together with
the battery. When the unit is connected to the mains supply, the battery will be recharged
automatically. Then the battery recharging indicator ( ) and the mains supply indicator
( ) will be lit at the same time. During the recharging course, the symbol flashes in
the top right corner of the LCD screen. After the battery is fully recharged, the symbol stops

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

flashing, and the battery recharging indicator ( ) is black.

Because of the capacity consumption during the storage and transport course, the battery
capacity is not full when it is used for the first time. Battery recharge should be considered
before the first use.

Recharging process:

Recharge at Recharge at Recharge

Precharge
constant current constant voltage complete

NOTE: The battery will automatically stop charging if you print an ECG report.

CAUTION
Repeated undercharging of the battery will damage the battery and reduce battery life.

3) Replacement
When the useful life of the battery is over, or foul smell and leakage are found, please
contact the manufacturer or the local distributor for replacement.

WARNING
1. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and the battery of the same model and
specification provided by the manufacturer must be used.

2. Danger of explosion -- Do not reverse the anode and the cathode when installing the
battery.

3. When the battery's useful life is over, contact the manufacturer or the local distributor
for disposal or dispose of the battery according to local regulations.

4. Remove the battery from the electrocardiograph when the electrocardiograph isn't
used for a long time.

5. If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent over-discharge.

CAUTION
If the battery has been fully charged and requires recharging after printing only a few
ECGs, consider replacement.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

13.4.2 Recorder Paper

NOTE: Recorder paper provided by the manufacturer should be used. Other paper may
shorten the life of the thermal print head. The deteriorated print head may lead to
illegible ECG reports and block the advance of the paper.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

Storage Requirements:

 Recorder paper should be stored in a dry, dark and cool area, avoiding excessive
temperature, humidity and sunshine.
♦ Do not put the recorder paper under fluorescence for a long time.
♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage
environment, which will lead to color change of the paper.
♦ Do not overlap the recorder paper for a long time, or else the ECG reports may
trans-print each other.

13.4.3 Visual inspection

Perform a visual inspection of all equipment and peripheral devices daily. If you notice any items
that need repair, contact a qualified service engineer to make the repairs.
 Check the case and display screen for cracks or other damage.
 Regularly inspect all plugs, cords, cables, and connectors for fraying or other damage.
 Verify that all cords and connectors are securely seated.
 Inspect keys and controls for proper operation.

13.4.4 Maintenance of the Main Unit and the Patient Cable

CAUTION
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.

The following safety checks should be performed at least every 12 months by a qualified person
who has adequate training, knowledge, and practical experience to perform these tests.

a) Inspect the equipment and accessories for mechanical and functional damage.
b) Inspect the safety related labels for legibility.
c) Inspect the fuse to verify compliance with the rated current and circuit-breaking
characteristics.
d) Verify that the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500μA, SFC
1000μA.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA,
SFC 500μA.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c.
10μA; SFC a.c. 50μA, d.c. 50μA.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA,
d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
j) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50μA (CF).
k) Test the essential performance according to IEC/EN 60601-2-25, or methods
recommended by the hospital or local distributor.
The leakage current should never exceed the limit. The data should be recorded in an equipment
log. If the device is not functioning properly or fails any of the above tests, the device has to be
repaired.

WARNING
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failures and possible health hazards.

1) Main Unit
♦ Avoid excessive temperature, sunshine, humidity and dirt.
♦ Put the dustproof coat on the main unit after use and prevent shaking it violently when
moving it to another place.
♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the
performance of the electrocardiograph can not be guaranteed.
2) Patient Cable
♦ Integrity of the patient cable, including the main cable and lead wires, should be
checked regularly. Make sure that it is conductible.
♦ Do not drag or twist the patient cable with excessive stress while using it. Hold the
connector plug instead of the cable when connecting or disconnecting the patient cable.
♦ Align the patient cable to avoid twisting, knotting or crooking in a closed angle while
using it.
♦ Store the lead wires in a big wheel to prevent any people from stumbling.
♦ Once damage or aging of the patient cable is found, replace it with a new one
immediately.

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SE-601 Series Electrocardiograph User Manual Cleaning, Care and Maintenance

3) Reusable Electrodes
♦ Electrodes must be cleansed after use and make sure there is no remainder gel on them.
♦ Keep suction bulbs of chest electrodes away from sunshine and excessive temperature.
♦ After long-term use, the surfaces of electrodes will be oxidized because of erosion and
other causes. By this time, electrodes should be replaced to achieve high-quality ECG
records.

CAUTION
The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for
recycling or proper disposal.

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SE-601 Series Electrocardiograph User Manual Accessories

Chapter 14 Accessories
WARNING
Only the patient cable and other accessories supplied by the manufacturer can be used.
Or else, the performance and electric shock protection can not be guaranteed.

14.1 Standard Accessories

Table 14-1 Standard Accessories List

Accessory Part Number

Power cord (European) 01.13.036638

Power cord (England) 01.13.036641

Power cord (American) 01.13.037122

Patient Cable (European) 01.57.471500

Patient Cable (American) 01.57.471499

Chest electrodes 01.57.040163

Limb electrodes 01.57.040162

Thermal recording paper 01.57.107560

Fuse 21.21.064172

Rechargeable Lithium Battery 21.21.064149

14.2 Optional Accessories

Table 14-2 Optional Accessories List

Accessory Part Number

01.57.107402 (Banana Style)

01.57.471016 (Banana Style)

Patient Cable (European)
01.57.107581 (Snap Style)

01.57.107583 (Grabber Style)

01.57.110375 (Banana Style)

Patient Cable (American) 01.57.471017 (Banana Style)

01.57.107582 (Snap Style)

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SE-601 Series Electrocardiograph User Manual Accessories

01.57.107584 (Grabber Style)

Pediatric Chest Electrodes 01.57.040168

Pediatric Limb Electrodes 01.57.040169

Grounding Wire 01.13.114214

Adult Disposable Adhesive Electrodes 01.57.471858

Disposable Adult ECG Electrodes 01.57.471862

Pediatric Disposable Adhesive Electrodes 01.57.471859

Disposable Resting Electrodes 01.57.471863

Snap/Banana Socket Adapters 01.57.471864

Clip/Snap/Banana Socket Adapter 01.57.040172

U disk 01.18.052275

SE-601 Backpack 01.56.465627

LS4208 Bar Code Reader (One-Dimension) 01.23.068023

1900GSR-2 Bar Code Reader

21.18.052311
(Two-Dimension)

83.61.111847
MT-201 Trolley
83.61.360760

02.04.111902
CA-100 Lead wire bracket
02.04.242639

SE-601 series electrocardiograph and accessories are available by contacting the manufacturer or
your local distributor.

NOTE:
1 The chest electrodes, limb electrodes, pediatric chest electrodes and pediatric limb
electrodes are not available in the U.S.

2 The part name may vary depending on context, but the part number is constant .

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SE-601 Series Electrocardiograph User Manual Warranty & Service

Chapter 15 Warranty & Service

15.1 Warranty

EDAN warrants that EDAN's products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of:
a) Damage caused by mishandling during shipping.
b) Subsequent damage caused by improper use or maintenance.
c) Damage caused by alteration or repair by anyone not authorized by EDAN.
d) Damage caused by accidents.
e) Replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials,
components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.

15.2 Contact information

If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.
Alternatively, you can send an email to EDAN service department at: [email protected].

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SE-601 Series Electrocardiograph User Manual Technical Specifications

Appendix 1 Technical Specifications

A1.1 Safety Specifications

IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
Comply with: IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-25

Anti-electric-shock type: Class І with internal power supply

Anti-electric-shock degree: CF type with defibrillation-proof

Degree of protection against

Ordinary equipment (Sealed equipment without liquid proof)
harmful ingress of water:

Disinfection/sterilization
Refer to Chapter 13 for details
method:

Degree of safety of
Equipment not suitable for use in the presence of flammable
application in the presence
gas
of flammable gas:

Working mode: Continuous operation

EMC: CISPR 11 Group 1, Class A

Patient NC <10μA (AC) / <10μA (DC)

Leakage
Current: SFC <50μA (AC) / <50μA (DC)

Patient NC <10μA (AC) / <10μA (DC)

Auxiliary
Current: SFC <50μA (AC) / <50μA (DC)

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SE-601 Series Electrocardiograph User Manual Technical Specifications

A1.2 Environment Specifications

Transport & Storage Working

Temperature: -20ºC (-4ºF) ~ +55ºC (+131ºF) +5ºC (+41ºF) ~ +40ºC (+104ºF)

25%RH~93%RH 25%RH~80%RH
Relative Humidity:
Non-Condensing Non-Condensing

Atmospheric
70 kPa ~106 kPa 86 kPa ~106 kPa
Pressure:

A1.3 Physical Specifications

Dimensions 310mm×322mm×101mm (12.2in×12.7in×3.98in)

Weight Approx. 3.0 kg (excluding recorder paper and battery)

SE-601A: 3.5" single color LCD screen;

Display SE-601B: 5.6" multicolor TFT LCD screen;

SE-601C: 5.6"multicolor TFT LCD touch screen.

A1.4 Power Supply Specifications

Operating Voltage = 100V-240V~

Rated Voltage: 14.8 V

Mains Supply:
Operating Frequency = 50Hz/60Hz

Input Power = 0.9A-0.4A

Rated capacity = 2500mAh

When the battery is fully charged, the electrocardiograph can work

normally at a temperature of 23ºC (±3ºC) for at least 5 hours; and it
Internal Li-ion Battery
can continually print at least 1.5 hours in the MANU mode or print at
Pack:
least 300 ECG reports of 3×4+1R in the AUTO mode.

100% Charge time: 5 hours

90% charge time: 4.5 hours

Fuse: T3.15AH250V, φ5×20mm

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SE-601 Series Electrocardiograph User Manual Technical Specifications

A1.5 Performance Specifications

Recording

Recorder: Thermal dot-matrix recorder

8 dots per mm / 200 dots per inch (amplitude axes)

Printing Density
40 dots per mm / 1000 dots per inch (time axes, @ 25 mm/s)

Recorder Paper: Folded thermal paper: 110mm×140mm, 150 pages

Effective Width: 104mm

Paper Speed: 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%)

HR Recognition

HR Range: 30 bpm ~300 bpm

Accuracy: ±1 bpm

ECG Unit

Leads: 12 standard leads

Acquisition Mode: Simultaneously 12 leads

A/D: 24 bits

Resolution: 2.52uV/LSB

Time Constant: ≥3.2s

SE-601A: 0.05Hz ~ 150Hz

Frequency Response:
SE-601B/C: 0.01Hz～300Hz

Gain: 2.5, 5, 10, 20, 10/5, AGC (mm/mV), ±5%

SE-601A: ≥50MΩ (10Hz)

Input Impedance:
SE-601B/C: ≥100MΩ (10Hz)

Input Circuit Current: ≤0.01μA

Input Voltage Range ≤±5 mVpp

Calibration Voltage: 1mV±2%

DC Offset Voltage: ±600mV

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SE-601 Series Electrocardiograph User Manual Technical Specifications

Minimum Amplitude: 20 μVp-p

Noise: ≤12.5µVp-p

Multichannel crosstalk ≤0.5mm

AC Filter: On /Off

SE-601A:
0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz
DFT Filter:

Filter SE-601B/C: 0.01Hz/0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz

EMG Filter: 25Hz/35Hz/45Hz/OFF

SE-601A: 150Hz/100Hz/75Hz
LOWPASS Filter:
SE-601B/C: 300Hz/270Hz/150Hz/100Hz/75Hz

SE-601A: ≥115dB (AC OFF)

CMRR
SE-601B/C: ≥123dB (AC OFF)

SE-601A: 1,000/sec/channel
Sampling Frequency
SE-601B/C: 16, 000/sec/channel

Pacemaker Detection

SE-601A: ±2 mV to ±700 mV
Amplitude
SE-601B/C: ±750uV to ±700 mV

SE-601A: 0.1ms to 2.0 ms

Width
SE-601B/C: 50μs to 2.0 ms

SE-601A: 10,000/sec/channel
Sampling Frequency
SE-601B/C: 16,000/sec/channel

External Input/Output (Configurable)

≥100kΩ; Sensitivity 10mm/V±5%;

Input
Single ended

≤100Ω; Sensitivity 1V/mV±5%;

Output
Single ended

WIFI (Configurable)

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SE-601 Series Electrocardiograph User Manual Technical Specifications

Transmitting Frequency 2400-2497MHz

Frequency Band 2400-2497MHz

Wireless protocol IEEE 802.11b/g/n

Modulation Type DSSS, CCK, OFDM

Transmitting Power 6~17dBm

Effective Radiated Power 6~17dBm

NOTE: Operation of the equipment below the minimum amplitude may cause inaccurate
results.

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SE-601 Series Electrocardiograph User Manual EMC Information

Appendix 2 EMC Information

Electromagnetic Emissions

Guidance and manufacture's declaration – electromagnetic emission

SE-601 series electrocardiograph is intended for use in the electromagnetic environment

specified below. The customer or the user of SE-601 series electrocardiograph should assure
that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

SE-601 series electrocardiograph uses RF

RF emissions energy only for its internal function. Therefore,

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

RF emission
Class A
CISPR 11
SE-601 series electrocardiograph is suitable
Harmonic emissions
Class A for use in all establishments, other than
IEC/EN 61000-3-2
domestic and those directly connected to the

Voltage fluctuations/ public low-voltage power supply network that

flicker emissions supplies buildings used for domestic purposes.

Complies
IEC/EN 61000-3-3

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SE-601 Series Electrocardiograph User Manual EMC Information

Electromagnetic Immunity

Guidance and manufacture's declaration – electromagnetic immunity

SE-601 series electrocardiograph is intended for use in the electromagnetic environment

specified below. The customer or the user of SE-601 series electrocardiograph should assure
that it is used in such an environment.

Electromagnetic
IEC/EN 60601 test
Immunity test Compliance level environment -
level
guidance
Electrostatic 8 kV contact 8 kV contact Floors should be wood,
discharge (ESD)
15 kV air 15 kV air concrete or ceramic tile.
IEC/EN 61000-4-2
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.

Electrical fast 2 kV for power 2 kV for power supply

Mains power quality
transient/burst supply lines lines
should be that of a
IEC/EN 61000-4-4 typical commercial or
hospital environment.

Surge 1 kV line to line 1 kV line to line

Mains power quality
IEC/EN 61000-4-5 2 kV line to ground 2 kV line to ground should be that of a
typical commercial or
hospital environment.

Power frequency 30 A/m 30 A/m Power frequency

(50Hz/60Hz) magnetic fields should
magnetic field be at levels

IEC/EN 61000-4-8 characteristic of a typical

location in a typical
commercial or hospital
environment.

Voltage dips, short Mains power quality

0 % UT; 0.5 cycle 0 % UT; 0.5 cycle
interruptions and should be that of a
At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°,
voltage variations typical commercial or
180°, 225°, 270° and 180°, 225°, 270° and
on power supply hospital environment. If
315° 315°
input lines the user of SE-601
IEC/EN 61000-4-11 series

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SE-601 Series Electrocardiograph User Manual EMC Information

electrocardiograph
requires continued
0 % UT; 1 cycle 0 % UT; 1 cycle
operation during power
and and
mains interruptions, it is
70 % UT; 25/30 70 % U T; 25/30
recommended that
cycles ) cycles )
SE-601 series
Single phase: at 0° Single phase: at 0°
electrocardiograph be
powered from an
uninterruptible power
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle
supply or a battery.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic Immunity

Guidance and manufacture's declaration – electromagnetic immunity

SE-601 series electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of SE-601 series electrocardiograph should assure that it is used
in such an environment.

IEC/EN 60601 Compliance Electromagnetic environment -

Immunity test
test level level guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of SE-601 series
electrocardiograph, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3Vrms d  1.2 P
IEC/EN 61000-4-6
150 kHz to 80 150 kHz to 80
MHz MHz

6Vrmsc) in ISM 6Vrmsc) in ISM

bands between bands
0.15 MHz and 80 between 0.15
MHz MHz and 80
MHz
Radiated RF 3 V/m 3 V/m d  1.2 P 80 MHz to 800 MHz

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SE-601 Series Electrocardiograph User Manual EMC Information

IEC/EN 61000-4-3 80 MHz to 2.7 80 MHz to 2.7 d  2.3 P 800 MHz to 2.7 GHz
GHz GHz
d 6 P /E at RF wireless

communications equipment bands

(Portable RF communications equipment
(including peripherals such as antenna
cables and external antennas) should be
used no closer than 30 cm (12 inches) to
any part of the PADECG, including
cables specified by the manufacturer).
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in 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
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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SE-601 Series Electrocardiograph User Manual EMC Information

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 SE-601 series
electrocardiograph is used exceeds the applicable RF compliance level above, SE-601 series
electrocardiograph should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating SE-601
series electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0
MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz,
14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99
MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

equipment

IMMUNITY
Test a)
Brand Modulation Maximum Distance TEST
Frequency Service a) b)
(MHz) Power(W) (m) LEVEL
(MHz)
(V/m)
Pulse
385 380-390 TETRA 400 modulationb) 1.8 0.3 27
18Hz
FM C)
GMRS 460, ±5 kHz
450 430-470 2 0.3 28
FRS 460 deviation
1kHz sine
710 Pulse
LTE Brand 13,
745 704-787 modulationb) 0.2 0.3 9
17
780 217 Hz
810 800-960 GSM Pulse 2 0.3 28

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SE-601 Series Electrocardiograph User Manual EMC Information

870 800/900,TETRA modulationb)

800, iDEN 820, 18 Hz
930 CDMA 850, LTE
Band 5
1720 GSM 1800;
1845 CDMA 1900;
Pulse
GSM 1900;
1700-1990 modulationb) 2 0.3 28
DECT; LTE
1970 217 Hz
Band 1, 3, 4,25;
UMTS
Bluetooth,
WLAN,802.11 Pulse
2450 2400-2570 b/g/n, RFID modulationb) 2 0.3 28
2450, LTE 217 Hz
Brand 7
5240 Pulse
WLAN 802.11
5500 5100-5800 modulationb) 0.2 0.3 9
a/n
5785 217 Hz
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m
test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while
it does not represent actual modulation, it would be worst case.

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SE-601 Series Electrocardiograph User Manual EMC Information

Recommended separation distances between portable and mobile RF communications

equipment and the EQUIPMENT or SYSTEM

Recommended separation distances between

portable and mobile RF communications equipment and SE-601 series electrocardiograph

SE-601 series electrocardiograph is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of SE-601 series
electrocardiograph can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and SE-601
series electrocardiograph as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum Separation distance according to frequency of transmitter(m)

output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz

(W) d  1.2 P d  1.2 P d  2.3 P

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
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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SE-601 Series Electrocardiograph User Manual Abbreviation

Appendix 3 Abbreviation

Abbreviation Statement

LCD Liquid Crystal Display

BP Blood Pressure

ECG Electrocardiogram/Electrocardiograph

HR Heart Rate

aVF Left Foot Augmented Lead

aVL Left Arm Augmented Lead

aVR Right Arm Augmented Lead

LA Left Arm

LL Left Leg

RA Right Arm

RL Right Leg

ID Identification

AC Alternating Current

USB Universal Serial Bus

AGC Auto Gain Control

NC Normal Condition

SFC Single Fault Condition

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