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EDAN SE-1200 Series User Manual

EDAN SE-1200 Series
139 pages
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EDAN Agile PLM Electronic Signature Information
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文件名称:SE-1200系列说明书_英文
文件编号:01.54.106764
版本:2.1
产品型号:SE-1200 Express;SE-1200
项目编码:2082C000
签批信息:
作者 : 肖, 丽军 (xiaolijun) 2016-01-07 17:18:55
审核人 : 陈, 勇强 (chenyongqiang) 2016-01-07 17:57:31
审核人 : 肖, 玉华 (xiaoyuhua) 2016-01-07 17:34:53
审核人 : 童, 晓密 (tongxiaomi) 2016-01-07 17:29:18
批准人 : 黄, 玉平 (huangyuping) 2016-01-08 14:30:45
版权©深圳市理邦精密仪器股份有限公司
理邦保密文件
EDAN CONFIDENTIAL

Table of Contents

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EDAN SE-1200 Series Specifications

General IconGeneral
BatteryRechargeable lithium-ion battery
Operating Temperature5°C to 40°C
ECG Channels12
DisplayLCD
RecordingThermal printer
Data StorageInternal memory
ConnectivityUSB
Battery LifeUp to 4 hours
Power SupplyAC 100-240V, 50/60Hz
ECG AnalysisAutomatic
Operating Humidity25% to 95% (non-condensing)

Summary

Chapter 1 Safety Guidance

1.1 Indications for Use/Intended Use

Defines the intended use of the electrocardiograph for acquiring ECG signals from adult and pediatric patients.

1.2 Warnings and Cautions

Provides essential information to ensure safe and effective operation and avoid potential dangers caused by improper operation.

1.2.1 Safety Warnings

Lists critical safety warnings regarding equipment operation, electrical hazards, and accessory usage.

1.2.2 Li-ion Battery Care Warnings

Details warnings related to improper handling, ignition, or explosion of the internal li-ion battery.

Chapter 2 Introduction

2.7 Features

Lists the key features and capabilities of the SE-1200 series electrocardiograph.

Chapter 3 Operation Preparations

3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes

Guides on properly connecting the patient cable to the device and electrodes for accurate signal acquisition.

3.2 Preparing the Patient

Details the necessary steps for patient preparation, including instructing and preparing the skin for electrode placement.

3.3 Attaching Electrodes to the Patient

Covers the procedures for attaching both reusable and disposable electrodes to the patient for ECG measurement.

3.4 Inspection Before Power-On

Lists essential inspection procedures for environment, power supply, cables, electrodes, and patient before operating.

3.5 Turning On/Off the Electrocardiograph

Explains the procedures for powering the electrocardiograph on and off using AC power or battery.

3.6 Loading/Replacing Recorder Paper

Provides instructions on how to load and replace the thermal recorder paper for printing ECG reports.

Chapter 4 Basic Operation Guidance

4.1.2 Entering Data

Details how to input patient information and other data using the keyboard and special character combinations.

4.3.1 About the Main Screen

Details the layout and elements displayed on the electrocardiograph's main operational screen.

4.3.3 About the Order Manager Screen

Describes the functionality and interface of the order manager for handling patient orders.

4.3.4 About the File Manager Screen

Details how to access and use the file manager for managing saved ECG data.

4.4 Work Mode Description

Explains the different operational modes available on the electrocardiograph.

Chapter 5 Entering Patient Information

5.1 Entering Patient Information Manually

Guides on manually entering patient demographic and clinical data into the system.

Chapter 6 Printing ECG Reports

6.1 Printing an ECG Report

Provides instructions on how to print ECG reports from the device.

6.1.1 Auto Mode

Details the steps for printing ECG reports in automatic mode, common for normal ECG tests.

6.4 Printing a Stored ECG Report

Provides methods for printing ECG reports that have been previously saved in the system.

Chapter 7 Transmitting ECG Data

7.1 Transmitting ECG Data to the PC

Outlines methods for transferring ECG data from the electrocardiograph to a personal computer.

7.1.2 Transmitting ECG Data in DAT and DAT V1.03 Format Through Ethernet Cable

Explains how to transmit ECG data in DAT formats using an Ethernet connection.

7.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format Through Ethernet Cable

Describes transmitting ECG data in advanced formats like SCP/DICOM via Ethernet.

Chapter 9 Managing Files

9.1 Transmitting Files

Details how to transmit ECG data files to a PC or other devices.

9.2 Exporting Files

Guides on exporting ECG data files to a U disk or other storage media.

Chapter 10 System Setup

10.1 Factory Defaults

Lists the default configuration settings for work mode and filter setup.

10.2 Work Mode Setup

Guides on configuring the electrocardiograph's operational modes and display styles.

10.3 Filter Setup

Details how to configure various filters (AC, DFT, EMG, Lowpass) to improve signal quality.

10.6 Transmission Setup

Covers settings for transmitting ECG data to PCs via wired or wireless networks.

Chapter 13 Cleaning, Care and Maintenance

13.2 Cleaning

Details the procedures and validated cleaning agents for the electrocardiograph and accessories.

13.3 Disinfection

Outlines the procedures for disinfecting the equipment and accessories.

13.4.1 Recharge and Replacement of Battery

Provides information on identifying battery capacity, recharging, and replacement.

Chapter 15 Warranty & Service

15.1 Warranty

Outlines the terms and conditions of the product warranty and conditions that void it.

Appendix 1 Technical Specifications

A1.1 Safety Specifications

Details the safety standards and specifications the electrocardiograph complies with.

A1.5 Performance Specifications

Lists performance metrics such as printing density, paper speed, and ECG unit specifications.

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