ISO13485 Approved Portable 12 Lead 3 Channel ECG Machine

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Product Description

Basic Information
Model NO.
DE 03
Certification
CE, FDA, MSDS, ISO13485
Group
for All Age Groups
Function
3 Channel/6 Channel/12 Channel 7 Inch Touch Screen
Transport Package
Export-Dedicated Paperboard Boxes
Specification
390mm× 300mm× 215mm
Origin
China
Capacity
20000/Year
Product Description
Portable 12 Lead 3 Channel ECG Machine (ISO13485 Approved)
  • Seven-inch HD large screen, full view display technology, 12 leads on the same screen display.
  • Standard power distribution capacity touch screen, enhancing human-machine interaction efficiency.
  • Equipped with tachycardia and bradycardia prompt functions for enhanced monitoring.
  • 7 Waveform printing time settings: 4S, 8S, 10S, 12S, 24S, 36S, 60S.
  • Includes more than 6 kinds of average QRS waveform combination printing functions for comprehensive detail display.
  • Supports remote USB flash drive upgrade and function expansion for faster updates.
ECG Machine View 1
ECG Machine View 2
ECG Machine View 3
ECG Machine View 4
ECG Machine View 5
Packaging & Shipping
Packaging
Shipping
Certifications
ISO Certification

ISO 13485 certification is an international standard for the medical device industry worldwide. This certification emphasizes the establishment and maintenance of a quality management system, ensuring that products meet rigorous industry requirements and consistently provide high-quality, safe, and reliable medical devices.

By complying with the ISO 13485 standard, comprehensive control is ensured from product design to production, sales, and after-sales service, meeting the needs for reliability and effectiveness in healthcare environments.

Company Profile

As a national high-tech enterprise and medical device manufacturer, we have been dedicated to the innovative development and manufacturing of ultrasound imaging, digital electrocardiograph, and digital radiology imaging products since 2006.

Our product portfolio consists of over 50 models in five major categories, including color Doppler ultrasound systems, black and white ultrasound machines, digital ECG machines, patient monitors, and digital radiography equipment. All products have received medical device registration certificates and European CE quality certification.

With technology research and development centers established globally, we hold more than 100 technology patents and possess independent intellectual property rights. Our products serve nearly 100,000 medical professionals across more than 100 countries and regions.

Facility 1
Facility 2
Facility 3
After Sales Service

Our dedicated team provides comprehensive assistance and solutions to ensure customer satisfaction. We offer prompt technical experts who are capable of resolving issues efficiently through remote support via phone, email, or digital tools.

In addition to remote support, we provide on-site repair services when necessary to restore equipment to normal operation. Our repair team maintains a stock of commonly used spare parts for quick replacement and minimal downtime.

Our Advantages
Expertise: Highly skilled professionals with extensive knowledge and experience.
Cutting-Edge Technology: Leveraging the latest innovations in the medical device market.
Comprehensive Solutions: A wide range of products to meet all diagnostic needs in one place.
Quality & Compliance: Rigorous testing and strict regulatory adherence (CE, FDA, ISO).
Customer-Centric: Personalized solutions designed to exceed expectations.
Proven Track Record: History of successful projects and satisfied medical professionals worldwide.
Frequently Asked Questions
1. What are the main certifications for this ECG machine?
The DE 03 model is fully certified with CE, FDA, MSDS, and ISO13485, ensuring it meets international safety and quality standards for medical devices.
2. Does the device support 12-lead display?
Yes, it features a 7-inch HD large screen with full view technology that allows for 12 leads to be displayed simultaneously on the same screen.
3. Can the software be upgraded in the future?
Yes, the machine supports remote USB flash drive upgrades, allowing for easy function expansion and software updates.
4. What kind of alarm functions does the ECG machine have?
The machine includes prompt functions for both tachycardia and bradycardia to alert medical staff of abnormal heart rates.
5. What type of after-sales support is offered?
We provide remote technical support via phone and email, as well as on-site repair services and a ready stock of spare parts for quick maintenance.
6. What are the printing options available?
The machine offers 7 different printing time settings ranging from 4S to 60S, along with multiple average QRS waveform combination printing options.

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