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NECG SE-1200 Pro

NECG SE-1200 Pro

Product catalog summary

About this Manual
This manual provides guidance on the operation and maintenance of the NECG SE-1200 Pro Electrocardiograph, emphasizing adherence to prevent malfunctions or accidents. Unauthorized reproduction or translation is prohibited by EDAN INSTRUMENTS, INC.

Product Information
The NECG SE-1200 Pro is designed for hospital use by trained professionals to acquire ECG signals for heart disease analysis in adults and pediatric patients. It is not intended for direct heart application, treatment, or monitoring.

Safety Guidance

Indications for Use: For acquiring ECG signals in healthcare settings.
Precautions: Users must be familiar with the manual and trained in its operation. Only authorized personnel should install or service the device.
Warnings: Avoid using near flammable anesthetics or high static electricity. Ensure proper electrode connection and use only manufacturer-approved accessories.

Operation Preparations
Includes patient preparation, electrode attachment, and device power-on procedures, emphasizing correct electrode placement and inspection before use.

Basic Operation Guidance
Covers login, ECG recording, patient information management, and user account switching, with instructions for entering and editing patient data.

ECG File Management and Editing
Details on viewing, measuring, diagnosing, and modifying ECG data, including auto-measurement and diagnosis features.

Printing and Exporting ECGs
Instructions for printing ECG reports and transmitting/exporting ECG data.

System Setup
Guidance on configuring sampling, print, storage, filter, transmission, and user settings, including system update and maintenance procedures.

Error Messages and Maintenance
Lists potential error messages and provides cleaning, care, and maintenance instructions, highlighting battery care and visual inspection.

Accessories and Warranty
Information on available accessories and warranty details, with contact information for service inquiries.

Technical Specifications
Includes safety, environmental, physical, power supply, and performance specifications.

EMC Information and Abbreviations
Provides electromagnetic compatibility details and a list of abbreviations used in the manual.

Safety Guidelines

Ensure disposable electrodes are used during defibrillation and avoid touching the patient or equipment simultaneously to prevent electrical hazards.
Maintain a minimum distance of 20cm for WIFI devices to comply with FCC RF exposure guidelines.
Only use manufacturer-approved equipment and accessories to ensure system safety and compliance with IEC/EN 60601-1 standards.

Protecting Personal Information

Implement safeguards to protect patient information and restrict device access to authorized personnel.
Ensure secure data storage and backup, and use firewalls and security measures against external threats.

Battery Care Warnings

Only authorized personnel should replace batteries, using the same model and specification.
Avoid exposing the battery to heat, fire, or water, and dispose of it according to local regulations.

General Cautions

Maintain operational temperatures between 5ºC and 40ºC and avoid dusty or corrosive environments.
Dispose of the device and accessories according to local regulations, and recycle batteries appropriately.

List of Symbols

Symbols include direct current, defibrillation-proof type CF applied part, ECG cable socket, caution, and more, each with specific meanings for device operation and safety.

Chapter 2: Product Information
The NECG SE-1200 Pro ECG is a high-end, portable electrocardiograph designed for multi-scenario use, featuring components like the main unit, ECG cable, electrodes, power cord, adapter, battery, and software.

Chapter 3: Operation Preparations
Includes patient preparation, electrode attachment, inspection before power-on, turning on/off procedures, and loading recorder paper.

Chapter 4: Basic Operation Guidance
Includes login, ECG recording, patient tab management, and patient information management.

Order Retrieval
Orders can be retrieved from a server by entering specific keywords and configuring download settings.

ECG File Management
ECG data is stored in the ECG File tab and can be searched, filtered, diagnosed, imported/exported, and uploaded to a server.

ECG Editing and Analysis
ECG data can be analyzed automatically or manually, with options to zoom, measure, and diagnose.

Printing ECG Reports
ECG reports can be printed using USB or WIFI-connected printers and shared via Bluetooth in various formats.

Transmission and Exporting Procedures
Includes logging into FTP software, configuring transmission setup, and exporting ECGs to a USB storage device.

System Setup
Includes sampling, print, storage, filter, transmission, parameter, and user settings, as well as system updates.

System Maintenance
Access requires contacting the manufacturer's maintenance personnel or local distributor, with a password necessary.

Error Messages
Lists various error messages and their causes, with solutions involving checking connections and ensuring proper setup.

Cleaning, Care, and Maintenance
Only EDAN-approved substances should be used for cleaning and disinfection to avoid warranty voidance.

Battery Management
The battery should be recharged and replaced as needed, with specific instructions for identifying capacity and handling replacements.

Recorder Paper
Use manufacturer-provided paper to avoid damage to the thermal print head.

Visual Inspection and Maintenance
Daily inspections should be conducted to check for damage and ensure all connections are secure.

Accessories
Lists standard and optional accessories with part numbers for easy identification.

Chapter 13: Warranty and Service
13.1 Warranty
EDAN guarantees its products meet specified standards and are free from defects within the warranty period. The warranty is void if damage occurs due to mishandling, improper use, unauthorized repairs, or if labels are removed.

13.2 Contact Information
For maintenance or technical specifications, contact your local distributor or email the EDAN service department.

Appendix 1: Technical Specifications
Includes safety, environmental, physical, power supply, and performance specifications.

Appendix 2: EMC Information
Complies with CISPR 11 for RF emissions and various IEC/EN standards for electromagnetic immunity.

Recommended Separation Distances
Guidelines for minimizing electromagnetic interference by maintaining specific distances between RF communications equipment and the ECG device.

Appendix 3 - Abbreviations

LCD: Liquid Crystal Display
BP: Blood Pressure
ECG: Electrocardiogram/Electrocardiograph
HR: Heart Rate
AC: Alternating Current
USB: Universal Serial Bus
AGC: Auto Gain Control
NC: Normal Condition
SFC: Single Fault Condition
PDF: Portable Document Format
FDA-XML: Food and Drug Administration-Extensible Markup Language
DICOM: Digital Imaging and Communications in Medicine

Catalog excerpts

About this Manual P/N：01.54.459239 MPN： 01.54.459239012 Release Date: Sep. 2022 © Copyright EDAN INSTRUMENTS, INC. 2022. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It reminds us that the product shall be used strictly in complying with this manual. The user’s process failing to adhere to this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (From now on called EDAN) cannot be held liable. EDAN owns the copyrights of this manual. Without the prior written consent of EDAN, any materials contained...

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Terms Used in this Manual This guide is designed to give critical concepts on safety precautions. WARNING A WARNING label advises against specific 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 helpful information regarding a function or a procedure.

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance The NECG SE-1200 Pro 12-lead electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiographs are 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. 1. This...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 1. The system is intended to use 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 system in the presence of flammable anesthetic mixtures with oxygen or other volatile agents. 4. Ensure that the power is turned off and the power...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 10. Electrodes of dissimilar metals should not be used; otherwise, they may cause a high polarization voltage. 11. The disposable electrodes can only be used for one time. 12. Do not touch the patient, bed, table, or device while using the ECG and a defibrillator. 13. Do not touch accessible parts of electrical equipment and the patient simultaneously. 14. Disposable electrodes must be used during defibrillation. 15. The use of equipment that applies high-frequency voltages to the patient (including electrosurgical equipment and...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 20. SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet providing the system. 21. Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1 approved in the system. The operation or use of non-approved equipment or accessories with the system is not tested or supported, and system operation and safety are not guaranteed. 22. Any non-medical equipment (such as the external printer) is...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 29. Connecting any accessory (such as an external printer) or other devices (such as the computer) to this electrocardiograph makes a medical system. In that case, additional safety measures should be taken during the installation of the system, and the system shall provide: a) Within the patient environment, a level of safety comparable to that offered 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 complies...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 32. All the accessories connected to the system must be installed outside the patient vicinity if they do not meet the requirement of IEC/EN 60601-1. 33. The appliance coupler or mains plug is used as isolation means from supply mains. Position the electrocardiograph where the operator can easily access the disconnecting device. 34. The electrocardiograph should be placed on a flat surface or EDAN's trolley. Avoid it dropping down to cause a strong shock. 35. When the touchscreen is damaged or broken, please contact the manufacturer...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 1.3.1 Protecting Personal Information Protecting personal health information is a significant component of security strategy. To protect personal information and ensure the proper device performance, the user should take necessary precautions by local laws and regulations and institutional policies. EDAN recommends health care organizations or medical institutions implement a comprehensive and multifaceted strategy to protect the information and systems from internal and external security threats. To ensure the patients’ safety and...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 1. The access/operation of the electrocardiograph is restricted to authorized personnel only. Assign only staff with a specific role the right to use the electrocardiograph. 2. Ensure that all device components maintaining personal information (other than removable media) are physically secure (i.e., cannot remove without tools). 3. Users should make a backup of data periodically. 4. Ensure that the electrocardiograph is connected only to the device authorized/approved by EDAN. Users should operate all EDAN deployed and supported...

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NECG SE-1200 Pro Electrocardiograph User Manual Safety Guidance 12. Please protect patients' information displayed on the screen and the data stored in the electrocardiograph. 13. The manufacturer or its authorized personnel can only upgrade the operating system of NECG SE-1200 Pro ECG. If the user reinstalls NECG SE-1200 Pro ECG with other operating systems not authorized by EDAN, the user shall bear the resulting security risks and losses. Possible security risks are stolen user information, sending SMS automatically, and locating yourlocation. 1. Improper operation may cause the internal Li-ion...

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