EDAN iSe Series User manual

About this Manual
P/N: 01.54.458432
MPN: 01.54.458432014
Release Date: April 2021
©Copyright EDAN INSTRUMENTS, INC. 2019-2021. 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) cannot 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.
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.
I

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 Introduction...................................................................................................1
1.1 Product Information..............................................................................................1
1.1.1 Product Overview .......................................................................................1
1.1.2 Indications for Use/Intended Use................................................................1
1.1.3 Features & Benefits ....................................................................................2
1.1.4 Controls, Indicators, and Connectors..........................................................2
1.1.5 Software Overview......................................................................................6
1.1.6 ECG Cable and Lead Wires .....................................................................12
1.1.7 Symbols....................................................................................................13
1.2 Safety Information..............................................................................................16
1.2.1 General Warnings.....................................................................................16
1.2.2 Protecting Personal Information................................................................19
1.2.3 Battery Care Warnings..............................................................................21
1.2.4 General Cautions......................................................................................22
Chapter 2 Setting Up the Electrocardiograph............................................................24
2.1 Inspecting the Electrocardiograph......................................................................24
2.2 Connecting the ECG Cable................................................................................25
2.3 Loading the Thermal Chart Paper (Option)........................................................25
2.4 Connecting an External APP/WIFI Printer (Option)............................................25
2.5 Powering the Electrocardiograph.......................................................................26
2.6 Logging in to the Electrocardiograph .................................................................27
2.7 Configuring the Ethernet....................................................................................28
2.8 Switching to Another User Account....................................................................28
Chapter 3 Preparing the Patient..................................................................................29
3.1 Instructing the Patient ........................................................................................29
3.2 Preparing the Skin .............................................................................................29
3.3 Attaching Electrodes to the Patient ....................................................................29
Chapter 4 Entering Patient Information .....................................................................33
4.1 Manually Entering Patient Information ...............................................................33
4.2 Scanning a Barcode (Option).............................................................................33
4.3 Retrieving Orders from Server ...........................................................................33
4.4 Modifying and Deleting Patient Information .......................................................34
4.5 Searching Patient information............................................................................35
4.6 Sorting/Queuing Patient Information..................................................................35
Chapter 5 Recording an ECG......................................................................................37
5.1 Real-Time Recording .........................................................................................37
5.2 Pre-Sample Recording.......................................................................................37
5.3 Rhythm ECG......................................................................................................38
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5.4 Pharmaceutical Study ........................................................................................38
5.5 VCG and SAECG...............................................................................................38
5.6 HRV ...................................................................................................................38
Chapter 6 Editing ECGs...............................................................................................39
6.1 ECG View ..........................................................................................................39
6.2 ECG Measurement/Diagnosis............................................................................40
6.3 Editing Measurements/Diagnosis.......................................................................41
6.4 Retrieving Diagnosis..........................................................................................42
6.5 Reviewing Electronic Medical Record................................................................42
6.6 Comparing ECGs...............................................................................................43
Chapter 7 Printing an ECG Report..............................................................................44
Chapter 8 Transmitting and Exporting ECGs ............................................................45
Chapter 9 Deleting ECGs.............................................................................................46
Chapter 10 System Setting..........................................................................................47
10.1 Sampling Setting..............................................................................................47
10.2 Patient Information Setting...............................................................................48
10.3 Print and Storage Setting.................................................................................49
10.4 Filter Setting.....................................................................................................52
10.5 Transmission Setting........................................................................................52
10.6 Parameter Setting............................................................................................53
10.7 User Setting .....................................................................................................54
10.8 Others..............................................................................................................55
10.9 System Update ................................................................................................56
10.10 System Maintenance .....................................................................................56
Chapter 11 System Message.......................................................................................57
Chapter 12 Cleaning, Care and Maintenance.............................................................58
12.1 General Points .................................................................................................58
12.2 Cleaning...........................................................................................................59
12.3 Disinfection ......................................................................................................59
12.4 Care and Maintenance.....................................................................................60
12.4.1 Recharging and Replacing the Battery ...................................................61
12.4.2 Thermal Chart Paper ..............................................................................62
12.4.3 Visual inspection.....................................................................................62
12.4.4 Maintaining Main Unit and ECG Cable ...................................................62
Chapter 13 Accessories...............................................................................................65
Chapter 14 Warranty and Service ...............................................................................67
14.1 Warranty ..........................................................................................................67
14.2 Contact information..........................................................................................67
Appendix 1 Technical Specifications .........................................................................68
A1.1 Safety Specifications .......................................................................................68
IV

A1.2 Environment Specifications .............................................................................68
A1.3 Physical Specifications ....................................................................................69
A1.4 Power Supply Specifications ...........................................................................69
A1.5 Performance Specifications.............................................................................69
Appendix 2 EMC Information ......................................................................................72
Appendix 3 Abbreviation.............................................................................................80
V

iSE Series Electrocardiograph User Manual Introduction
Chapter 1 Introduction
1.1 Product Information
1.1.1 Product Overview
The iSE series electrocardiograph features intuitive user interface with simple workflow,
clinical-quality ECG recorder, and design. For more features, see section
1.1.3 Features & Benefits .
The device consists of the following components: main unit, ECG cable, electrodes,
electrode adapters, power cord and power adapter, battery, and iSE software.
There are two models, iSE-1210 and iSE-1810. iSE-1210 uses DE12 for ECG acquisition
while iSE-1810 uses DE18 sampling box. For the performance difference between DE12
and DE18, see A1.5 Performance Specifications . For each model, there are three styles.
See the following illustrations.
With thermal printer With handle but no thermal printer No thermal printer or handle
NOTE: All illustrations in this manual are provided as examples only.
1.1.2 Indications for Use/Intended Use
The iSE series electrocardiograph is intended to acquire 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. The
electrocardiograph is capable of network communications and supports the informatized
management of workflows in hospital and healthcare facilities.
WARNING
1. This system is not designed for intracardiac use or direct cardiac application.
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iSE Series Electrocardiograph User Manual Introduction
2. This system is not intended for home use.
3. This system is not intended for treatment or monitoring.
4. This system is intended for use on adult and pediatric patients only.
5. The results given by the system should be examined based on the overall clinical
condition of the patient, and they cannot substitute for regular checking.
1.1.3 Features & Benefits
Fingerprint Access
Log in to the electrocardiograph easily and quickly.
Touch screen operation based on Android operating system
Easy to use, intuitive interface.
Small (1.2 kg±0.3 kg minimum), at least 8 hours of continuous
usage on Li-ion battery
Use the electrocardiograph in a wide variety of care environments.
Easy communication and synchronization with EDAN’s SE-1515 PC ECG
Communicate with the server via WIFI or mobile network.
Large storage capacity
Minimum of 16 GB local memory, allows you to extend the device’s storage capacity by
using an external Secure Digital (SD) card.
Support standard 9/12/15/16/18-lead ECGs
You can easily switch between acquisition modules for ECG acquisition.
Compatibility with external printer
You can connect an external APP printer or a printer with infrastructure WIFI
1.1.4 Controls, Indicators, and Connectors
This section describes the controls, indicators, and connectors that are part of the
electrocardiograph.
Figure 1 Top
1
2
Name Description
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iSE Series Electrocardiograph User Manual Introduction
1 Camera Reserved.
Indicates power usage in different colors:
Blue: the electrocardiograph is powered by battery.
Green: the electrocardiograph is connected to AC
2 Power light
power. Or when the electrocardiograph is connected
to both the battery and AC power, the battery is full.
Orange: the electrocardiograph is connected to both
the battery and AC power, and the battery is
recharging.
Figure 2 Front
1 3 2 1
Name Description
1 Speaker holes /
Scans one-dimensional or two-dimensional codes.
2 Infrared scanner
NOTE: When you use the infrared scanner, DO NOT
look straight at it.
3 NFC reader
Reads contactless tags on your devices like
smartphones or tablets.
Figure 3 Left

iSE Series Electrocardiograph User Manual Introduction
7
2
3 4 5 6
1
Name Description
Pull down the switch to open the paper tray. To close
the tray, close the door directly.
1 Paper tray switch NOTE:
This is only applicable to electrocardiographs with
thermal printer.
2 Mains AC power
Connects the system to an AC power supply via
power cable.
3 LAN port Connect to a LAN cable.
Connect to your keyboard, mouse, U disk, USB
4
5
USB interface
printer, and code scanner.
NOTE: Only FAT32 format is supported by the USB
storage devices.
6 Type-C interface Used only by the manufacturer. NOT for recharging.
7
SIM and SD cards
two-in-one slot
Insert SIM card and SD card for data transmission
and storage.
Figure 4 Back
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iSE Series Electrocardiograph User Manual Introduction
1 2
Name Description
1 Paper tray (option) Contains thermal chart paper roll.
2 Handle (option) /
Figure 5 Right
1 2 3 4
Name Description
1 ECG cable socket Connects to the ECG cable.
2 DE18 socket Connects to the DE18 connection cable.
3 Fingerprint identifier
Identifies user fingerprint for login to the
electrocardiograph.
To power on, press and hold the On/Off button
when the device is off.
4 On/Off button
When the device is on:
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iSE Series Electrocardiograph User Manual Introduction
Press and hold the button. A menu pops up,
providing the following options: restart, power off,
and screenshot.
To enable power-save, gently press the button.
Figure 6 Bottom
1
2
3
Name Description
1 Battery
Contains a battery to supply power when the unit is
not connected to AC power.
2 Battery
compartment switch
Pull the switch left to make the battery pop out.
3 Product label Contains product information.
1.1.5 Software Overview
This section provides an overview of the system software. It describes the basic screen
layout and main menu functions. Familiarize yourself with these features before
attempting to use iSE.
Figure 7 Main Menu
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iSE Series Electrocardiograph User Manual Introduction
Submenu Description
Displays patients that have ordered an ECG test
Patient and contains a number of operations you can
perform on patient information.
Stores ECGs that have been recorded and
ECG File contains a number of operations you can perform
on ECGs.
System Setting Review or change system settings.
STAT mode bypasses patient data entry. A
STAT ECG temporary ID number is assigned to the patient to
identify stat tests.
EDAN Cloud Reserved
Figure 8 Patient tab
The Patient tab displays all the patients that have ordered an ECG test. If patients’
priority is urgent, they will be listed at the top and their information displayed in red.
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iSE Series Electrocardiograph User Manual Introduction
Room No.
Name
Age
Outp./Inp./PE ID
ECG Test
Department
Button/Icon Description
Return to the
Main Menu .
Display the on-screen number of patients to be tested. This number
updates in real time.
This icon provides the following options: sequence setting, filtering
setting, download setting, and order server.
Switch to another user account. This button is visible when user login
is enabled in system setting > user setting.
Male
Female
Gender unknown
Search for a patient. Fuzzy search is supported.
Enter new patient information.
Delete patient information.
Download batches of patient information from the PC.
NOTE:
A maximum of 200 latest orders can be downloaded from the server
at a time.
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iSE Series Electrocardiograph User Manual Introduction
Activate iSE’s infrared scanner to scan the barcode so as to retrieve
the Outpatient / Inpatient / PE ID. Tap this icon again to stop
scanning.
Download the specific patient information from the PC. You need to
enter the default key word for order querying so that the information
with the order can be downloaded. For details, see section 4.3
Retrieving Orders from Server .
Disable the filter when it is used to filter the patient information.
STAT ECG. For more information, see Figure 7.
Figure 9 ECG recording screen
Pace spike
Button/Icon Description
Real-time heart rate. It automatically updates during ECG recording.
Display the pacing spike when the iSE detects a pacemaker pulse. If
you don’t need to see the pacing spike, tap on this icon to turn it off.
Electrode placement locations.
Intelligent ECG sampling. This icon is displayed when you enable
intelligent sampling in the setting.
NOTE: This option is available in the Auto mode of standard ECG
recording.
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iSE Series Electrocardiograph User Manual Introduction
Start or stop ECG recording.
NOTE: iSE can record up to 1,800-second ECGs.
Re-acquire ECGs.
Auto Recording mode, including Auto and Manual. Tap on it to toggle
between the two modes.
In the Auto mode, the system will acquire ECGs at the set time and
then print a report. If the user stop recording before the time, the
system will print the last 10s of ECG.
In the Manual mode, the system will not stop recording or printing
ECGs until you tap the stop button.
This icon provides the following setting options: gain, filter, speed,
and lead mode. Tap the icon again to hide these options.
Gain.
Options are: 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV, 10 mm/mV, and 20
mm/mV. The default gain is 10mm/mV.
Filter. Options are: 25 Hz, 35 Hz, 45 Hz, 75 Hz, 100 Hz, 150 Hz, 270
Hz, 300 Hz, and 350 Hz. The default filter is 100Hz.
Speed. Options are: 5 mm/s, 12.5 mm/s, 25 mm/s, and 50 mm/s. The
default speed is 25mm/s.
Lead mode.
•If DE12 is used, options are: pediatric mode, 12 lead (Standard or
Cabrera). The default setting is 12 lead (Standard).
•If DE18 is used, options are: pediatric mode, 12 lead (Standard or
Cabrera), 15 lead, 16 lead, and 18 lead. The default setting is 18
lead.
Record rhythm ECGs. To toggle between single-lead and three-lead
rhythm strips, swipe the screen left or right.
Return to the previous menu.
Figure 10 ECG file tab
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iSE Series Electrocardiograph User Manual Introduction
Button/Icon Description
Search for ECGs that have been recorded. Enter the key
word for search and the system will display the ECGs that
meet the criteria. Fuzzy search is supported.
Filter ECGs. You can filter ECGs by using the criteria such
as uploaded or not, diagnosed or not, printed or not, and
the exam time.
Retrieve diagnosis. You can get from server the latest
ECG measurements and diagnosis for all ECG files in this
tab.
Get or update signature. You can download doctors’
electronic signatures from the server. With this button, you
can also update doctors’ signatures stored in your
electrocardiograph.
Export ECGs to USB memory device. You can select the
file format for export. See section 10.3 Print and Storage
Setting .
Upload ECGs to the server. You can choose one or more
or even all ECGs to upload at a time.
Delete ECGs. You can choose one or more or even all
ECGs to delete at a time.
Print a report for an ECG file. You can select the APP or
WIFI printer.
Print
Press and hold an ECG file. This button will appear.
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iSE Series Electrocardiograph User Manual Introduction
Modify the patient information of an ECG file. You can
modify all patient information except ID and exam item.
Press and hold an ECG file. This button will appear.
Edit NOTE:
If patient information such as names or gender are
modified, the information elsewhere with the same ID
number will be updated.
Sync
Retrieve diagnosis and doctor’s signature for an ECG file.
Press and hold an ECG file. This button will appear.
Send a notification to the server to take priority over other
Urgent
ECGs. The ECG will be highlighted in red and listed on
top.
Press and hold an ECG file. This button will appear.
All (16)
The number of ECGs stored in the electrocardiograph is
16.
To Upload (8) The number of ECGs to be uploaded to server is 8.
Diagnosed (4)
The number of ECGs of which diagnosis is retrieved from
the server is 4.
To Print (16) The number of ECGs to be printed is 16.
Return to the main menu.
1.1.6 ECG Cable and Lead Wires
The ECG cable processes the patient’s ECG data and transmits it to the
electrocardiograph.
WARNING
The performance and electric shock protection can be guaranteed only if the patient
cable and electrodes from the manufacturer are used.
Figure 11 ECG cable and lead wires for DE12
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iSE Series Electrocardiograph User Manual Introduction
Connect to
electrocardiograph
Connect to electrodes
ECG cable
Lead wires
Figure 12 DE18 sampling box, DE18 cable, and lead wires
Connect to
electrocardiograph
Connect to
DE18 sampling
DE18 cable
DE18 sampling box,
Electrode connector
Cable connector
1.1.7 Symbols
No. Symbol Description
1 DEFIBRILLATION-PROOF TYPE CF APPLIED PART
2 Direct current
3 Caution
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iSE Series Electrocardiograph User Manual Introduction
4 Consult operating instructions
5 Near-field communication
6 USB interface
7 SIM and SD cards slot (two-in-one)
8 Computer network
9 On/Off switch
10 General symbol for recovery/recyclable
11 Part Number
12 SERIAL NUMBER
13 Date of manufacture
14 MANUFACTURER
15
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
16 CE marking
17 Disposal method
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