Equipment Name: LUM-R5500
Manufacturer: Zhengzhou Magique Huaer Biotech Co., Ltd.
Intended Use: Photobiomodulation for cellular therapy, muscle recovery, and rejuvenation.
Transportation and Installation:
The LUM-R5500 is shipped as a fully assembled unit and does not require installation. We provide door-to-door delivery service.
Installation is only necessary if there are space limitations (such as narrow doors) that require the device to be disassembled to fit through.
Detailed disassembly and reassembly instructions are available in the video provided.
Note: The LUM-R5500 device does NOT require calibration.
Frequency: Every 6 months or every 1000 hours of use.
Responsible: Biomedical engineer or trained technician.
Activities to Perform:
✅ Visual inspection: Check cables, structure, and fans.
✅ Internal and external cleaning: Use a soft non-woven fabric, sponge, pure cotton cloth, or microfiber cloth for cleaning. Prepare cleaning supplies such as warm water, neutral soap or detergent, and a specialized acrylic cleaner for best results. Products must be authorized by local government sanitary agency.
✅ LED inspection: Verify if all and each LED are lighting.
✅ Ventilation system check: Inspect and clean fans.
✅ Voltage verification: Ensure operation at 220V and 6000W.
✅ Power-on and operation test: Simulate usage to verify proper performance.
✅ Temperature: Check the Operational temperature.
✅ Recording of operating parameters.
Instruments Required:
Frequency: Every time a fault is detected.
Responsible: Authorized biomedical technician.
Activities:
✅ Diagnosis of the issue.
✅ Repair or replacement of defective parts.
✅ Safety tests after repair.
✅ Detailed recording of the procedure.
Possible Failures and Solutions:
|
Failure |
Possible Cause |
Solution |
|
Does not turn on |
Blown fuse |
Replace the fuse |
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Missing led or part of led not working |
Defective LEDs |
Replace LED modules |
|
Overheating |
Blocked ventilation |
Clean filters and fans or replace fan |
|
Screen error |
Software issue |
Restart and update firmware |
Frequency: After each use and during preventive maintenance.
Approved Materials:
✅ Disinfectant solutions authorized by local sanitary agency for medical use.
✅ Microfiber cloths.
✅ Compressed air for internal circuit cleaning.
��� Steps:
Avoid:
❌ Alcohol or chlorine-based cleaners.
❌ Abrasive tools.
❌ Excessive water exposure.
Frequency: Every 6 months.
Parameters to Verify:
|
Parameter |
Standard Value | Instrument |
| Internal Temperature |
<45°C |
Infrared Thermometer |
| Operating Voltage | 220V |
Multimeter |
Also have a visual inspection of all LED lights to see if any is not working.
Mandatory Records:
✅ Date and responsible technician.
✅ Verification results.
✅ Biomedical engineer's signature.
|
Date |
Task |
Description |
Result (✔/✖) |
Notes/ Comments |
Performed By |
Signature |
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Visual Inspection |
Check for physical damage, loose cables, or signs of overheating. |
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LED Functionality Test |
Verify all LEDs are operational and emitting correct wavelengths. |
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Display and Control Panel |
Ensure screen is responsive and all buttons function properly. |
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Ventilation System |
Check that all fans are running properly; clean dust if necessary. |
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Cleaning (Internal & External) |
Wipe surfaces with a non-abrasive disinfectant (e.g., hypochlorous acid solution). |
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Connection & Wiring Check |
Inspect all electrical connections for damage or loose cables. |
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Software/ Firmware Check |
Ensure software is functioning properly and check for updates. |
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Safety System Check |
Test emergency stop button and safety cut-off functions. |
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Check Power Supply |
Ensure voltage and current levels meet manufacturer specifications. |
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Deep Cleaning |
Perform a full system cleaning, including internal components. |
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Structural Integrity |
Check for loose screws, mechanical wear, or potential issues in bed movement. |
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Date |
Detected Failure |
Cause |
Solution Applied |
Replaced Parts |
Technician's Signature |
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Date |
Part cleaned |
Product Used |
Performed by |
Signature |
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Date |
Verified Parameter |
Obtained Value |
Standard Value |
Correct Instrument |
Adjustment Made |
Signature |
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LED Verification |
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All LED lights/chips ON |
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Internal Temperature |
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<45°C |
Infrared Thermometer |
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Operating Voltage |
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220V-380V |
Multimeter |
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Spare Part Name |
Specification |
Remarks |
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Upper Fan |
150x mm |
For top cover |
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Lower Fan |
120x mm |
For bottom cover |
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Speaker |
N/A |
Equipment sound system |
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Lower Cover Screws |
Standard |
Casing fasteners |
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LED Panel |
Left & Right Side |
1 meter each |
This protocol complies with:
✅ Decree 4725 of 2005 (Regulation of medical devices in Colombia).
✅ Resolution 3100 of 2019 (Maintenance of biomedical equipment).
✅ ISO 13485 (Quality management in medical devices).
