53
Appendix 6
Declaration and warranty
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:
Name:
HeartSine Technologies Ltd.
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)
2014/53/EU
ROHS2 Directive 2 (Article 4)
2011/65 EU with exceptions Annex III (6c – lead in
copper alloy)
Conformity to the essential requirements of the legislation(s) have been demonstrated by using the
following standards:
Health and Safety Article 3.1a:
IEC 60601-1:2005
EMC Article 3.1b:
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
Spectrum Article 3.2:
EN 300 328 v2.1.1
Signed for and on behalf of: HeartSine Technologies Ltd
Place and Date of Issue: Belfast, United Kingdom, 8th November 2019
Signature
_________________________________
Date ________________________
Rebecca Funston
Senior Manager, Regulatory Affairs & Quality Assurance
HeartSine Technologies Ltd
.
H001-011-026-5
