Apéndice 6; Declaración Y Garantía; Eu Declaration Of Conformity - Stryker HeartSine Gateway Manual Del Usuario

Apéndice 6
Declaración y garantía

EU Declaration of Conformity

Radio equipment:
Name: HeartSine Gateway
Model: Gateway
Catalog: ACC-GTW-XX-01, 350-STR-XX-GW, 360-STR-XX-GW, 450-STR-XX-GW, 500-
STR-XX-GW (where XX denotes language)
Manufacturer:
HeartSine Technologies Ltd.
Name:
Address: 203 Airport Road West, Belfast, BT3 9ED
Country: United Kingdom
This declaration of conformity is issued under the sole responsibility of HeartSine Technologies Ltd. who
declares that the above named HeartSine Gateway is in conformity with the following regulations:
Radio Equipment Directive (RED)
ROHS2 Directive 2 (Article 4)
Conformity to the essential requirements of the legislation(s) have been demonstrated by using the
following standards:
Health and Safety Article 3.1a:
EMC Article 3.1b:
Spectrum Article 3.2:
Signed for and on behalf of: HeartSine Technologies Ltd
Place and Date of Issue: Belfast, United Kingdom, 8th November 2019
Signature
_________________________________
Rebecca Funston
Senior Manager, Regulatory Affairs & Quality Assurance
HeartSine Technologies Ltd
2014/53/EU
2011/65 EU with exceptions Annex III (6c – lead in
copper alloy)
IEC 60601-1:2005
Directive 2014/30/EU, EN55032 / EN55011:2016, EN60601-1-
2:2014,
EN 301 489-1 V2.1.1, EN 301 489-17 V3.1.1, EN61000-4-
2:2009, EN61000-4-3:2006, EN61000-4-8:2010
EN 300 328 v2.1.1
Date ________________________
.
H001-011-026-5
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