zerona Z6, Manual

Page: 43 / 44

TECHNICAL SPECIFICATIONS | 38
TECHNICAL SPECIFICATIONS
Relevant Information Specifications
Device

Weight: 71lbs / 32kg

Height: 70 in / 177.8 cm (Average – Adjustable)

Full Color Touch Screen Control Center

Four independent Adjustable Arms

4 locking Anti-static casters

Powder coated metal frame

Non-allergenic material finished with black carbon fiber

Applied Part: Type B

Leakage Current 0.3 -0.5 µA (Micro Amps)
Laser

6 line generating diode modules

Output: 17.25mW +/- 1.25mW

Wavelength: 635 nm +/- 10nm

Duty Cycle: CW (Continuous 100%)
Power

Source: 100-240VAC 50-60Hz

Fuse Rating: T2AH 250V
Temperature

Operating Temp: 59 to 85°F (15 to 29°C) <50% Relative
Humidity

Transporting: -22 to 158°F (-30 to 70°C) <75% Relative
Humidity
Atmospheric Pressure (Altitude)

Rated operating altitude ≤ 2000 m

Normal barometric pressure 80.0 kPa
Erchonia Corporation
650 Atlantis Rd.
Melbourne, FL. 32904 USA
QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
Trade name: Zerona® Z6-OTC
Model Number: SHR
Classifications
US

Device Class: II

Laser Class: II
UL/CSA

Electrical Class 1
Applicable Codes
FDA

21CFR 820 – Quality System Regulations

21CFR 1040.10 and 1040.11 by laser Notice 50
ISO

13485 – Medical Device Quality

60825-1 – Laser Safety
EMC 2004/108/EC
LVD 2006/95/EC
IEC 60601-1-2 EMC
IEC 60601-1-1 Safety
CB Certified
Legend:
FDA – US Food & Drug Administration, which includes the CDRH (Center for Device Radiological Health)
ISO – International Standards, Harmonized with US, Canadian, European and Asian standards
Doc No. Issue Date CR No. Rev. Level Rev. Date
ZERONA Z6-OTC-NC 3/23/2015 20-16-ADM 2 06/14/2016
ZERONA Z6-OTC-NC 3/23/2015 38-16-ADM 3 09/01/2016
ZERONA Z6-OTC-NC 3/23/2015 05-17-ENG 4 03/31/2017