SEFAM PolyLink, Процедура установки и использования

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Technical characteristics PolyLink kit
Physical features
Dimensions of the PolyLink module (L x W x H) :
Dimensions of the effort/position kit (L x W x H) : 85 x 63 x 22 mm
37 x 67 x 22 mm (alone)
41 x 71 x 30 mm (fixing equipment to belt
included)
Dimensions of the transport bag (L x W x H) : 200 x 150 x 60 mm
Weight of the PolyLink module: 60 g
Weight of the effort/position kit: 60 g
Radio certifications
Europe :

EN 301489-1 V2.1.1 (2017-02) and EN 301489-17 V3.1.1 (2017-02) Electromagnetic Compatibility
(art. 3.1b)

EN 300328 V2.1.1 (2016-11) Effective use of spectrum allocated (art. 3.2)
Japan :
 Giteki : 209-J00169
CE marking
PolyLink kit: 2018.
Regulatory requirements
Risks concerning this medical device are evaluated according to the ISO 14971 standard, specifically
with regard to global residual risk.
The PolyLink kit used with S.Box complies with the following directives and standards:

Directive 93/42/EEC of the Council concerning medical devices, modified by the European
Directive 2007/47/EC.
 Directive 2014/53/EU (RED) of the European Parliament and of the Council on the harmonization
of the laws of the Member States relating to the making available on the market of Radio
Equipment.
 Directive 2006/66/EC of the European Parliament and of the Council on batteries and
accumulators.

Directive 2011/65/EC of the European Parliament and of the Council on the restriction of the use
of certain hazardous substances in electrical and electronic equipment (RoHS).
 Directive 2012/19/EC of the European Parliament and of the Council on waste electrical and
electronic equipment (WEEE).

CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1:
General requirements for basic safety and essential performance.
 CEI 60601-1-2:2014: Medical electrical equipment. Part 1: General requirements for safety.
Collateral standard: Electromagnetic compatibility – Requirements and tests.