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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