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Optical Specifications
Treatment Wavelengths
Skin Tone Adjustments
Maximum Output Power
Wavelength Ratio
Aiming Beam Output
Aiming Beam Wavelength
Operating Modes
Pulse Frequency
Pulse Duration
Laser Safety Goggles
Electrical Specifications
Input Voltage
Input Current
Battery Pack
Beam Delivery Assembly (BDA) Specifications
BDA Model
Hand piece Assembly (-B6)
Empower Attachments
7.2.
Spare Parts
Warning: Do not use any accessories and/or cables not specified or sold as replacement parts. Use of unauthorized accessories and/or
optical fibers not specified or sold for use with this system may result in unsafe treatment emissions or damage to the laser system.
Item
Beam Delivery
Assembly
Safety Goggles
Safety Goggles
Power Cord
External Power Supply
Battery
7.3.
Electromagnetic Compatibility (EMC) Tables
This laser system has been tested to comply with the requirements of EN/IEC 60601-1-2 for electromagnetic compatibility (EMC). The following
pages list the tests performed and corresponding test levels. The user, operator, installer, or assembler of this product is advised of the following:
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the
•
information provided in this document.
•
Portable and mobile RF communications equipment can affect medical electrical equipment.
•
Use only the power cord provided with this product, or an approved alternate.
Warning: The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased
immunity of this product.
Warning: Equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, this
device should be observed to verify normal operation in the configuration in which it will be used.
All medical electronic devices must conform to the requirements of EN/IEC 60601-1-2. Precautions, adherences to the EMC guideline information
provided, and verification of all medical devices in simultaneous operation are required to ensure the electromagnetic compatibility and coexistence
of all other medical devices prior to a laser therapy treatment.
7.3.1.
Emissions Test Summary
Specification
CISPR 11/EN 55011
Group 1, A
Conducted Emissions
CISPR 11/EN 55011
Group 1, A
Radiated Emissions
RSR-000886-000 (5)
Light (I, II)
80% of 980 nm + 20% of 810 nm
<4.0 mW
650 nm ± 20 nm
Continuous Wave (CW) or Pulsed
2, 10, 20, 100, 200, 500, 1000, 2500, 5000, 10000 Hz
50% duty cycle at any given pulse frequency setting
OD5+ 808nm & 980nm
100-240 VAC; 50/60 Hz
≤ 400 VA
Li-Ion 9.9V, 5.0Ah
New Empower Delivery System
Basic hand piece (BHP) with 600μm fiber core
Flat Window-IQ, Small Cone-IQ, Small Massage Ball-IQ, Large Massage Ball-IQ, Large
Cone-IQ
(NOTE: "-IQ" indicates the attachment is the quick disconnect version with RFID tag)
Description
Opaque protective double sheathed fiber with attached
Empower™ hand piece and attachments
808 nm and 980 nm OD 5+ Over glasses
808 nm and 980 nm OD 5+ Regular
Medical Grade Power Cord, 2.9 m
Medical Grade Power Supply
49.5WHr, 9.9V, 5.0Ah (3S2P) Battery
Frequency Range
0.15 MHz – 30 MHz
30.0 MHz – 1,000 MHz
980 nm ± 20 nm & 810 nm ± 20 nm
or
Medium (III, IV)
15W
Dark (V, VI)
15W
100% 980 nm
Image
Compliance Status
PASS
PASS
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