® HeartSine EC Declaration of Conformity Manufacturer; HeartSir Canberra House 203 Airport Road West Belfast BT3 9ED. uk Device: Pad-Pak Model: Pad-Pak-03 Description: Combined Battery and Electrode Cartridge Medical Device Classification: Class | under the provisions of the directive 93/42/EEC Rule 12 of ‘Annex IX. HeartSine Technologies deciares that the HeartSine PAD-Pak (PAD-PAK-03), an accessory to a therapeutic medical device in the range of Automated External Defibrillators, are designed and manufactured in conformity with a) The essential requirements (Annex I) and provisions of the European Medical Device Directive (MOD) European Council Directive 93/42/EEC (as amended by 2007/47/EC) and is subject to the procedure set out in Annex VII EC Declaration of Conformity. b) Article 4 of ROHS2 Directive (2011/65 EU), with exceptions Annex Ill (6c — lead in copper alloy) and Annex IV (17 — lead in soler for portable emergency defibrillators). Cortification SGS Certificate Number ISO 13486:2003 GBO2I54195 GB02/54195 1SO 9001:2008 GB02I54194 Date _23e0 Fea 20/6 Signature James McGuinness Quality Manager HeartSine Technologies Ltd. H001-071-003.5 De ee ce ero os eee De eG eee eed WEP er rrr