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Chapter 9: General Guidance and Manufacturer's Declaration: Essential
Performance & Electromagnetic Emissions & Immunity
Essential Performance
Temperature range shall vary between 385 and 405ºC.
Electromagnetic Emissions & Immunity
The medical device requires specific precautions regarding EMC and needs to be installed and put into
service cord to the EMC information provided in this document. This declaration only applies to the
®
following Novoxel
device: Tixel2 TXLD0012.
This device is intended for use in the electromagnetic environment specified below. The operator of the
device should verify that the device is operated in such an environment.
Emission Test
Electrical Spec.
Energy Source
Tip Surface Material (Skin contact)
Console Weight
Handpiece Weight
Total Device Weight
System Dimensions
Packaging Dimensions
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
P/N T2-UM-E-ENG Rev 10
Compliance
100-240 VAC ±
10%
T5A
50/60Hz
Up to 300W
Thermal
Titanium
5400 gr
330 gr
6100 gr
26 L × 30 W × 31 H cm
57 L × 38 W × 44 H cm
Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
Class B
cause any interference in nearby electronic equipment.
Class B
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
Electromagnetic Environment - Guidance
Group 1
Novoxel.com
User Manual TXLD0012
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Page | 63
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