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PRODUCT STANDARDS THAT APPLY
The Device has been tested to or complies with the following
standards:
IEC/EN 60601-1:2006/A12:2014. Medical electrical equipment.
General requirements for basic safety and essential perfor-
mance.
IEC/EN 60601-1-2:2015 Medical electrical equipment. General
requirements for basic safety and essential performance.
Collateral standard. Electromagnetic compatibility. Require-
ments and tests.
IEC/EN 60601-1-6:2010 AMD12013 Medical Electrical
Equipment – Part 1General Requirements for Basic Safety and
Essential Performance –Collateral Standard: Usability.
etc ...
14
SPECIFICATION
Specification
Produce name
LED Hair Regrowth
Model
MZ-07
Adapter:
Power source
Input: 100-240V~50/60Hz, 0.25A
Output: 5.0V 1.0A
Weight
1600g±10g
Dimensions
205 x249 x220 (W x L x H)
Wavelengths
Red 660nm
Energy Source
LEDs
LED Irradiance: 30mw/cm2
Power Density
Average Irradiance: < 5mw/cm2
10 minutes everyday
Treatment time
Location for Use
Head
Environment of Use
OTC
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6,
Safety and EMC
IE C60601-1-11, IEC 60601-2-57
Biocompatibility
ISO 10993-1, ISO 10993-5, ISO 10993-10
Temperature: 14~95℉
Operating Environment
Humidity: 30-80%RH
Temperature: -4~140℉
Storage Environment
Humidity: 30-90%RH
THE SYMBOLS AND DESCRIPTION
No.
Symbols
Manufacturer.
1
"WEEE (Waste Electrical and Electronic Equipment)". This
2
means that the battery should not be disposed of in the
household waste.
Description
15
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