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PHILIPS
Declaration of Conformity
Philips Medical Systems
22100 Bothell Everett Highway
Bothell, WA 98021-8431 USA
Manufacturer:
Philips Medical Systems
22100 Bothell Everett Highway
Bothell, WA 98021-8431
USA
European Representative:
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Str. 2
71034 Boeblingen
Germany
Notified Body:
TUV SUD Product Service GMBH
Zertifizierstelle
Ridlerstrasse 65
D-80339 München
Germany
NB# 00123
Product Name andlor Model:
HeartStart HS1
Models
—
M5066A, M5068A
Classification:
Class llb, Rule 9, Annex II
EU Directive(s):
93/42/EEC concerning medical devices, as amended by 2007/47/EC
GMDN Code and Title:
48047 Non-rechargeable public automated external defibrillator
UMDNS Code and Title:
17116 Defibrillators, Automated, External
Start of CE-marking:
Serial# Al 2G-03956, July 26, 2012
Product OptionslAccessories:
M5070A
Primary Battery Pack
M5071A
Adult Pads Cartridge
M5072A
Infant/Child Pads Cartridge
M5073A
Adult Training Pads Kit
M5074A
Infant/Child Training
Pads Kit
M5075A
Standard Carrying Case
M5076A
Slim Carrying Case
M5089A
External Manikin Adapter
M5093A
Replacement Adult Training Pads
M5094A
Replacement Infant/Child Training Pads
861487
HeartStart Configure
68-PCHAT Fast Response Kit
Declaration Statement:
We hereby declare that the above mentioned products meet the applicable provisions of 93/42/EEC
concerning medical devices, as amended by 2007/47/EC, Class lIb, Rule 9, Annex II, excluding Section
4 which does not apply. An application has not been lodged with any other Notified Body for conformity
assessment of the above mentioned products.
Place and Date of Issue:
Bothell, WA August 12, 2015
Signature:
Dennis Daniels, Director Regulatory Affairs
TMPLOO53 Rev B
Page 1 of 1
LCO1 97-1 01 Rev G
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