IEC 60601-2-2 Neutral Electrode Temperature Rise Tester
IEC60601-2-2 Neutral Electrode Tester precisely assesses temperature rise, ensuring patient safety and reliable standard compliance.
MOQ: 1
Price: To be quoted
Standard Packaging: 1000*1000*1000CM
Delivery Period: 25 working days
Payment Method: L/C,T/T
Supply Capacity: 100
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Neutral Electrode Temperature Rise Tester Description
ZLR-320 Neutral Electrode Temperature Rise Tester
The ZLR-320 Neutral Electrode Temperature Rise Tester is a specialized testing device developed to evaluate the thermal performance of neutral electrodes (also known as patient return electrodes or plates) used in high-frequency surgical equipment. It simulates real-world conditions to measure temperature rise under controlled high-frequency currents, replacing traditional volunteer testing with consistent, repeatable results that align closely with human subject outcomes. This ensures enhanced patient safety by preventing excessive localized heating that could cause burns.
Designed in full compliance with IEC 60601-2-2:2017 (clause 201.15.101.5) and the Chinese national standard GB9706.202-2021, the tester supports comprehensive assessment of neutral electrodes for adult, child, and infant applications.
Key Features
- Simulated testing environment eliminates the need for human volunteers while delivering reliable, standard-compliant results.
- High-precision temperature mapping using a dense sensor array for accurate hotspot detection.
- Adjustable high-frequency RMS current: 700 mA (adult), 500 mA (child), 350 mA (infant).
- Rapid temperature measurement completed in under 1 second (well within the 15-second standard limit), with accuracy of ยฑ0.4 ยฐC.
- Integrated Contact Quality Monitor (CQM) simulation, measuring impedance from 2 ฮฉ to 100 ฮฉ with ยฑ(3% + 3 ฮฉ) accuracy; supports relative change monitoring and alarms at 130%โ140% increase.
- Supports testing at different simulated skin adipose tissue thicknesses: 20 mm, 15 mm, 10 mm, 5 mm.
- Flexible test load durations (e.g., 60 s standard, or 10 s / 300 s optional).
- Bilingual Chinese/English interface with Windows 10 OS and API support for LIMS integration.
ZLR-320 Neutral Electrode Temperature Rise Tester Technical
| Parameter | Specification |
|---|---|
| Standards Compliance | IEC 60601-2-2:2017 (201.15.101.5), GB9706.202-2021 |
| Temperature Measurement Board (Gold-plated area) | 12 cm ร 22 cm |
| Spatial Resolution | 1 cmยฒ |
| Number of Temperature Sensors | 416 (16 ร 26 grid) |
| Sensor Deployment | 2 cm from each edge of the board |
| High-Frequency Current (RMS, adjustable) | Adult: 700 mA Child: 500 mA Infant: 350 mA |
| Test Load Duration | Standard: 60 s (optional: 10 s, 300 s) |
| Simulated Skin/Adipose Tissue Thickness | 20 mm / 15 mm / 10 mm / 5 mm |
| Temperature Measurement Time | < 1 second (standard requires < 15 seconds) |
| Temperature Measurement Accuracy | ยฑ0.4 ยฐC (standard requires < 0.5 ยฐC) |
| CQM Impedance Simulation Range | 2 ฮฉ ~ 100 ฮฉ |
| CQM Impedance Measurement Accuracy | ยฑ(3% + 3 ฮฉ) |
| CQM Relative Impedance Change Range | 0% ~ 160% (alarm at 130%โ140% increase) |
| Overall Dimensions (W ร H ร D) | 1040 mm ร 640 mm ร 640 mm |
| Weight (including main unit, table, cables) | โ66 kg |
| Power Input | 220 V AC, 50 Hz |
| Rated Power (at max 700 mA current) | 0.5 A |
| Operating Environment | Initial temperature: 23 ยฑ 2 ยฐC (electrode & test surface) |
| Storage Environment | 0 ~ 50 ยฐC, 10% ~ 90% RH |
| Operating System | Windows 10 (embedded computer) |
| Interface Language | Chinese / English |
| Integration | API support for LIMS |
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IEC 60601-2-2 Testing Device for Neutral Electrodes Applications
- Medical Device Manufacturers โ Essential for R&D and production quality control of neutral electrodes and high-frequency electrosurgical equipment, enabling precise verification of thermal performance before market release.
- Testing and Certification Laboratories โ Ideal for independent third-party compliance testing to IEC 60601-2-2:2017 and GB9706.202-2021 standards, supporting certification processes and regulatory submissions (e.g., 510(k) for FDA or equivalent approvals).
- Electrosurgical System Validation โ Simulates clinical use conditions for adult, pediatric, and infant neutral electrodes under various current loads and contact impedances, ensuring safe dispersion of high-frequency current without risk of patient burns.
- Quality Assurance and Safety Auditing โ Used to detect thermal anomalies, validate Contact Quality Monitoring (CQM) functionality, and confirm consistent results equivalent to human volunteer tests, reducing risks in surgical environments.
- Research and Development โ Supports engineering studies on electrode design improvements, material thermal characteristics, and optimization for different patient groups or simulated tissue thicknesses.
IEC 60601-2-2 Testing Device for Neutral Electrodes Video
Testing Device for Neutral Electrodes FAQs
Q1: Why use a simulated tester like the ZLR-320 instead of human volunteer testing?
A: The ZLR-320 provides consistent, repeatable, and objective results that closely match real human tests while eliminating ethical concerns, variability between subjects, and safety risks associated with volunteer exposure to high-frequency currents.
Q2: Which standards does the ZLR-320 fully comply with?
A: It complies with IEC 60601-2-2:2017 (specifically clause 201.15.101.5 for temperature rise testing) and the equivalent Chinese standard GB9706.202-2021, covering neutral electrode safety requirements for high-frequency surgical equipment.
Q3: What patient groups and current levels can be tested?
A: The device supports adult (700 mA RMS), child (500 mA RMS), and infant (350 mA RMS) applications with adjustable high-frequency currents, allowing comprehensive evaluation across different patient sizes.
Q4: How accurate and fast is the temperature measurement?
A: Temperature is measured in under 1 second with ยฑ0.4 ยฐC accuracy using 416 sensors in a 1 cmยฒ grid, exceeding the standard's requirements (<15 seconds and <0.5 ยฐC accuracy).
Q5: Does the tester include Contact Quality Monitor (CQM) functionality?
A: Yes, it simulates and measures CQM impedance (2โ100 ฮฉ range, ยฑ(3% + 3 ฮฉ) accuracy) and monitors relative changes, with alarms triggered at 130%โ140% increase as per IEC 60601-2-2 requirements.
Q6: Can different tissue thicknesses be simulated?
A: Yes, the tester supports adjustable simulated skin/adipose tissue thicknesses of 20 mm, 15 mm, 10 mm, and 5 mm to replicate various patient conditions.
Q7: What operating system and languages are supported?
A: It runs on an embedded Windows 10 system with a bilingual Chinese/English interface and offers API integration for Laboratory Information Management Systems (LIMS).
Q8: Who is this tester suitable for?
A: It is ideal for medical device manufacturers (R&D and QC), independent testing labs, certification bodies, and research institutions involved in electrosurgical equipment validation and compliance.
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