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NECG SE-301

Product catalog summary

About this Manual
This manual provides guidance on the operation and maintenance of the SE-301 Electrocardiograph, emphasizing compliance to avoid malfunctions or accidents. Unauthorized reproduction of the content is prohibited.

Product Information
The SE-301 Electrocardiograph is intended for use in hospitals by trained professionals to acquire ECG signals from patients. It is not suitable for home use or direct cardiac application.

Safety Guidance

Indications for Use: For acquiring ECG signals from adult and pediatric patients in healthcare facilities.
Warnings: Avoid use in the presence of flammable anesthetics or high static electricity. Use only manufacturer-supplied accessories.
Cautions: Follow proper operation procedures to prevent equipment damage or inaccurate data.

Operation Preparations
Instructions include loading recorder paper, preparing the patient, and connecting cables and electrodes.

Sampling and Printing ECG
Details on entering patient information and printing ECG reports are provided.

Managing ECG Records
Guidance on transmitting, copying, and deleting ECG records, as well as printing patient records.

Settings
Information on configuring work modes, filters, patient information, and transmission settings.

Error Messages and Troubleshooting
Chapters dedicated to identifying and resolving common errors.

Cleaning, Care, and Maintenance
Instructions for cleaning and disinfecting the device and its components, as well as battery maintenance.

Accessories and Warranty
Information on available accessories and warranty details.

Technical Specifications
Appendices provide detailed safety, environmental, physical, power supply, and performance specifications.

Safety Guidance

Use non-polarizing electrodes to avoid DC offset voltage during defibrillation.
Pacemakers may affect equipment results.
Disposable electrodes are mandatory for defibrillation.
Avoid using electrodes of dissimilar metals.
Do not touch the patient or equipment during ECG and defibrillator use.
Maintain a 20cm distance between WIFI equipment and the human body.
Ensure all connected equipment complies with IEC/EN standards.
The device is not safe for MRI environments.

Lithium Battery Care Warnings:

Only authorized personnel should replace the battery.
Dispose of batteries according to local regulations.

General Cautions:

Device restricted to sale by or on the order of a physician.
Operate within specified temperature ranges.

Introduction:
The SE-301 is a 3-channel electrocardiograph capturing ECG signals from 12 leads simultaneously, featuring a high-quality thermal recorder and various operational modes.

Operation Preparations:

Load thermal paper correctly.
Prepare the patient by explaining the procedure and cleaning the skin.

Electrode Attachment and Specifications

Reusable and disposable electrodes are available, with identifiers and color codes complying with standards.

Procedures for Electrode Connection

Ensure cleanliness and proper placement of electrodes.

Inspection Before Power On

Ensure no electromagnetic interference and proper connections.

Sampling and Printing ECG

Enter patient information manually or via network connection.

Managing ECG Records

ECG records can be saved, transmitted, and deleted as needed.

Chapter 5: File Management

Instructions for deleting and printing patient records.

Chapter 6: Settings

Details on configuring work modes, filters, and transmission settings.

Chapter 7: Error Messages

Common error messages and their causes.

Troubleshooting

Solutions for operating, printing, and transmission problems.

Cleaning, Care, and Maintenance

Use approved cleaning agents and perform regular maintenance checks.

Patient Cable Maintenance
Regular checks on the integrity of the patient cable are essential.

Electrode Care
Clean electrodes after use and replace if oxidized.

Disposal and Recycling
Dispose of the device and accessories according to local regulations.

Accessories
Use only manufacturer-supplied accessories.

Warranty and Service
The manufacturer guarantees products meet specifications within the warranty period.

Technical Specifications
Safety: Complies with IEC and EN standards.
Environment: Operating temperature is 5ºC to 40ºC.
Physical: Dimensions and weight specifications.
Power Supply: Operates on 100V-240V with a built-in lithium battery.
Performance: Features a thermal dot-matrix recorder.

Electromagnetic Compatibility (EMC)
Complies with CISPR 11 standards for specific electromagnetic environments.

Technical Specifications:
Details on frequency bands, technologies, and recommended separation distances.

Catalog excerpts

About this Manual P/N: 01.54.456811 MPN: 01.54.456811017 Release Date: December 2018 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 the manufacturer. (hereinafter called the manufacturer) cannot be held liable. The manufacturer owns the copyrights of this manual. Without prior written consent of the manufacturer, any materials contained in this manual shall not...

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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.

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SE-301 Electrocardiograph User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the 3-Channel Electrocardiograph. 1.1 Indications for Use/Intended Use The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph...

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SE-301 Electrocardiograph User Manual Safety Guidance 1. The electrocardiograph is provided for the use of 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. The EQUIPMENT is protected against malfunction caused by electrosurgery. 4. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixture...

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SE-301 Electrocardiograph User Manual Safety Guidance 13. To avoid a polarization or DC offset voltage, use non-polarizing electrodes(which will not form a DC offset voltage when subjected to a DC current) such as silver/silver-chloride types if there is a situation where there is a likelihood that a defibrillation procedure will be necessary. 14. There is no danger for patients with pacemakers. However, if a pacemaker is used, the results given by the equipment may be invalid, or lose the clinical significance. 15. Disposable electrodes must be used during defibrillation. 16. Electrodes of dissimilar...

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SE-301 Electrocardiograph User Manual Safety Guidance 25. 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. 26. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.). 27. Multiple portable socket-outlets shall not be placed on the floor. 28. Do...

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SE-301 Electrocardiograph User Manual Safety Guidance 32. 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. 33. The potential equalization conductor can be connected to that of other equipment when necessary, to make sure that all these devices are connected to the potential equalization bus bar of the electrical installation. 34. The electrocardiograph shall not be serviced or maintained while in use with a patient. 35. The appliance coupler or mains...

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SE-301 Electrocardiograph User Manual Safety Guidance 1. Improper operation may cause the lithium battery (hereinafter called battery) to be hot, ignited or exploded, and it may lead to the declination of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages. 2. Only qualified service engineer 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...

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SE-301 Electrocardiograph User Manual Safety Guidance 1. Federal (U.S.) law restricts this device to sale by or on the order of a physician. 2. Avoid liquid splash and excessive temperature. The temperature must be kept between 5 °C and 40 °C during operation, and it should be kept between -20 °C and 55 °C during transportation and storage. 3. Do not use the equipment in a dusty environment with bad ventilation or in the presence of corrosive. 4. Make sure that there is no intense electromagnetic interference source around the equipment, such as radio transmitters, mobile phones etc. Attention:...

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SE-301 Electrocardiograph User Manual Safety Guidance Operating instructions Casing Button General symbol for recovery/recyclable Part Number SERIAL NUMBER AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Disposal method

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SE-301 Electrocardiograph User Manual Safety Guidance Power adapter port Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician Refer to User Manual 21 (Background: Blue; Symbol: White) Warning 22 (Background: Yellow; Symbol&Outline: Black) Non- ionizing electromagnetic radiation MR Unsafe–Keep away from magnetic resonance imaging (MRI) equipment NOTE: 1. * Applicable to the Electrocardiograph configured with WIFI or 4G module. 2. For details about buttons of the keyboard, refer to Chapter 2. 3. The user manual is printed in black and white. - 9 -

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