Gima Rescue LIFE, Руководство пользователя

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ELPRO S.r.l.
Doc.N.: TF-RescueLife-2.0/8.1ENG-6.0
MEDICAL ELECTRONICS
Rev. 6.0
*
IF YOU WANT RECEIVE DEDICATED DECLARATION OF CONFORMITY FOR YOUR DEVICE SERIAL NUMBER AND/OR UPDATED ONE,
PLEASE CONTACT ELPRO S.R.L. OFFICE TO THE EMAIL info@elpromedical.com
Declaration of EC conformity
to council
Directive 93/42/EEC of 14 June 1993 and subsequent amendments
concerning medical devices
MANUFACTURER:
ELPRO S.r.l.
Strada del Rondello, 5
10028 Trofarello (TO)
ITALY
PRODUCT: Defibrillator
MODEL:
Rescue LIFE
GMDN Code: 17882
CLASS:
II b
STANDARDs REFERENCES:
EN ISO 13485:2016
EN 60601-1:2006+A1:2013+A12:2014, EN 60601-1-2:2015, EN 60601-2-4:2011,
EN 60601-2-27:2014, EN 60601-2-31:2008+A1:2011, EN 62353:2014, EN 62366-1:2015,
EN 60601-1-6:2010, EN 62304:2006, EN ISO 14971:2012, EN ISO 15223-1:2012,
MEDDEV 2.7/1 Rev.4, MEDDEV 2.12-1 Rev.8, MEDDEV 2.12/2 Rev.2
SERIAL NUMBER : *
W
E HEREWITH DECLARE THAT THE ABOVE MENTIONED PRODUCT(S) MEET THE TRANSPOSITION INTO NATIONAL
LAW, THE PROVISIONS OF
C
OUNCIL
D
IRECTIVE
93/42/EEC
OF
14 J
UNE
1993
CONCERNING MEDICAL DEVICES,
ACCORDING TO ESSENTIAL REQUIREMENTS AND SUBSEQUENT AMENDMENTS.
ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER.
ALSO, THE
DEFIBRILLATOR IS MANUFACTURED BASED ON: DIRECTIVE 2011/65/EEC
AND
ITS SUBSEQUENT
AMENDMENTS ( ROHS ). THE PRODUCT CONCERNED HAS BEEN MANUFACTURED UNDER A QUALITY MANAGEMENT
SYSTEM ACCORDING TO ANNEX II OF DIRECTIVE 93/42/EEC.
NOTIFIED BODY:
MTIC InterCert S.r.l. (N.0068)
Via Moscova, 11
20017 Rho - MI, ITALY
EC MARKING: 0068
EC CERTIFICATE N°:
0068/QCO – DM/031-2009
EXPIRE DATE:
2021, May 19
th
FIRST ISSUE: 2009, May 20
th
PLACE, DATE :
TROFARELLO (TO) – 2019, 01
st
March
SIGNATURE:
Dr. CESARE MANGONE
MANAGEMENT REPRESENTAIVE