BTS TMJOINT, User Manual

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BTS Biomedical
BTS TMJOINT
appendix F
declaration of conformity
DECLARATION OF CONFORMITY
BTS SpA
Via della Croce Rossa 11, 35129 Padova (PD) – Italy
Tel. +39 049 981 5500 Fax +39 049 792 9260
declare under our sole responsibility that the product(s):
name / description: Electromyographic system / device for the functional analysis of dental occlusion.
model: TMJOINT
S/N: SN
satisfies the essential requirements of the Medical Devices Directive 93/42/EC (and its amendments inluding
2007/47/CE), and therefore carries the CE marking of the European Union. The conformity assessment procedure is
according to the article 11 of the directive (Annex II.3 full quality assurance) and the article 12 it is not applicable.
In accordance with Annex IX of the 93/42/EC directive it is classified as follow:
CLASS “IIa” (rule 10)
In accordance with IEC 60601-1 is also classified as follow:
Class: internally powered device Applied part type: BF
The product conforms to the following standards:
EN ISO 14971 Medical Devices - Application of risk management to medical devices.
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for basic safety and
essential performance.
IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: electromagnetic compatibility -
Requirements and tests.
IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and
essential performance - collateral Standard: Usability
EN 62304 Medical device software - Software life-cycle processes
ETSI EN 301 489-3 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Electromagnetic
Compatibility (EMC) – standard for radio equipment and services – Part 3: Specific
conditions for Short-Range Devices (SRD) operating on frequencies between 9 KHz and
40 GHz.
ETSI EN 301 440-2 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Short Range Devices
(SRD) – Radio equipment to be used in the 1 GHz to 40 GHz frequency range – Part 2:
Harmonized EN covering essential requirements of Article 3(2) of the R&TTE Directive.
This compliance is valid ONLY for the equipment identified when used in a manner consistent
with the intent of the referenced documents and according to the product’s usage manual.
Notified Body : TÜV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 München – Germa-
ny, Identification N. 0123.
EC certificate N. G1 12 10 65301 003 valid until January, 16 2018.
Padova, Date
Bruno Ros
CEO
BTS S.p.A.