Declaration Of Conformity (Eu); Specifications And Environmental Conditions; Device Specifications - Companion Ctx Benutzerhandbuch

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Empower Delivery System
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Laser Safety Eyewear
9.3.

Declaration of Conformity (EU)

PRODUCT IDENTIFICATION
Product name
Companion ® CTX
MANUFACTURER
Name of company
®
LiteCure ,LLC
LiteCure, LLC (the parent company of Companion
representative and legal manufacturer that the above-mentioned product is delivered in conformity with the
following Council Directives as transposed in the national laws of the Member States through determination of
compliance with the following standards:
CONFORMITY ASSESSMENT
Legislation applied
Low Voltage Directive (2014/35/EU)
Electromagnetic Compatibility Directive (2014/30/EU)

10. Specifications and Environmental Conditions

10.1.

Device Specifications

Model Name
Model Number
Device Classifications
Electrical Equipment
Laser Product
User Interface
Touch Screen Display
Emission Indicator
Mechanical Specifications
Dimensions
Weight
Environmental Specifications
Operation temperature
Charging temperature
Storage temperature
Humidity
Pressure
Cooling
Optical Specifications
Treatment Beam Wavelength(s)
Skin/Coat Color Adjustments
Maximum Output Power
Wavelength Ratio
Aiming Beam Output
Aiming Beam Wavelength
Operating Modes
Pulse Duration
Pulse Frequency
Laser Safety Goggles
Electrical Specifications
Input Voltage
Input Current
Battery Pack
Electrical Specifications
BDA Model
Hand piece Assembly (-S6)
Empower Attachments
RSR-000524-000 (1)
Model/number Description
LTC-1511-C Therapeutic laser system for animal use only
Address
101 Lukens Dr, Suite A
New Castle, DE 19720
USA
®
Companion ® CTX
LTC-1511-C-B6
Class I Type B device per EN/IEC 60601-1
Class 4 laser product per IEC 60825-1
7" HD Display with Touch Screen
Audible Signal (50 to 75 dB), LED (front display)
37 cm (L) x 21 cm (W) x 17 cm (H) │14.5 in x 8.25 in x 6.75 in
4.1 kg │9 lb
10°C to 35°C │ 50°F to 95°F
10°C to 32°C │ 50°F to 89.6°F
-20°C to 70°C │ -4°F to 158°F
≤ 80% RH Non-Condensing
70-106 kPa
Thermal Electrically Cooled with Forced Air
980 nm ± 20 nm & 810 nm ± 20 nm
Light (I, II) or Medium (III, IV)
15 W
80% of 980 nm + 20% of 810 nm
<4.0 mW
650 nm ± 20 nm
CW or Pulsed
2, 10, 20, 100, 200, 500, 1000, 2500, 5000, 10000 Hz
50% duty cycle at any given pulse frequency setting
OD5+ 808 nm & 980 nm
100-240 VAC; 50/60 Hz
≤ 400 VA
Li-ion 9.9V, 5.0Ah
™
Empower Delivery System
Basic hand piece (BHP) with 600μm fiber core
Small Cone-IQ, Small Massage Ball-IQ, Lage Massage Ball-IQ, Lage Cone-IQ
(NOTE: "-IQ" indicates the attachment is the quick disconnect version with RFID tag)
User Manual – CTX
Representative
Quality & Regulatory Manager
) declares under sole responsibility as the regulatory
Standards applied
Safety: IEC 60601-1:2005+A1:2012
EMC: IEC 60601-1-2:2015
Usability: IEC 60601-1-6:2010+A1:2013
Laser: IEC 60601-2-22:2007+A1:2013
Laser: IEC 60825-1:2014
Dark (V, VI)
15 W
100% 980 nm
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