Applicable Standards; The Tixel2 Device - Overview - Novoxel Tixel2 User Manual

Applicable Standards

The European Council Medical Device Directive 93/42/EEC.
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EN 60335-2-23:2003 + A1:2008 + A11:2010.
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IEC 60335-2-23:2003 (Fifth edition) (incl. corr.2:2008) + A1:2008.
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+ A2:2012, in conjunction with EN 60335-1:2012 (Fifth edition)3.
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IEC 60335-1:2010 (Fifth edition).
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IEC 60601
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EN 55014-1: 2006 + A1:2009 + A2:2011.
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EN 61000-3-2: 2006 + A1:2009 + A2:2009.
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EN 61000-3-3: 2008, EN 55014-2: 1997 + A1:2001 + A2:2008 + IS1:2007.
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The EMC Directive 2004/108/EC, Category IV Standards, harmonized under article 6(2).
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SOR-98-282: 2014, Canadian Medical Device Regulations.
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The WEEE Directive 2012/19/EU, Management of Electronic Waste.
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IEC 60601-1-1-9
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The Tixel2 device – Overview
The Tixel2 is a thermo-mechanical fractional skin treatment device, which employs a specialized thermal
component ("the Tip") to generate a matrix of either ablative micropores or non-ablative coagulative sites
on the treated tissue. The fractionated thermal effect on the treated tissue is created by brief direct contact
of the Tip with the skin. The duration of tissue contact (and subsequent thermal energy transfer) is
precisely modifiable.
The Tixel2 may perform a limited number of pulses, as ordered by the customer. Once the purchased
amount of pulses has been exhausted, an additional amount may be purchased. It is enabled by entering a
code, provided by Novoxel, directly on the device or via a dedicated mobile application.
Tixel2 is designated for use in professional healthcare facility environment only.
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User Manual TXLD0012
P/N T2-UM-E-ENG Rev 10