Declaration Of Conformity; Declares That The Ce-Marketed Product; Labels - Mach Power HC-AED7000 Manual Del Usuario

1.5

Declaration of Conformity

Manufacturer: Beijing M&B Electronic Instruments, Co., Ltd
Room 6319, Building 1, No.27 Yongwang Road Daxing
Bioengineering and Medicine Industry Base Zhongguancun Science Park Daxing District 102629
Beijing PEOPLE'S REPUBLIC OF CHINA
Product Name Automatic External Defibrillator
Device Type AED7000
1.5.1

Declares that the CE-marketed product

Product Name
Device Type
Model Number
Accessories
Compliance
1.5.2 Standard
General
ISO13485 2003
ISO14155 2003
ISO14971 2007
EN980 2008
EN1041 1998
IEC60601-1:1988+A1:1991+A2:1995+A13:1996 Type BF, Internally Powered, Conti-
Sicurezza
nuous operation, Defibrillator Proof Operation
IEC60601-1-4 2000
IEC60601-1-6 2006
IEC60601-2-4 2002
IEC62304 2006
EMC IEC60601-1-2: 2007
1.6

Labels

Automatic External Defibrillator
BF
AED7000
See list in manual
Complies with Council Directive 93/42/EEC (Medical Device Directive) of
June 14 1993 class IIb Annex II
Trademark
Manufacturer
CE Mark
BF and Defibrillation-proof applied parts
7