Operating instructions

LIFEPAK 500 Automated External Defibrillator Operating Instructions xiii
©1996–2003 Medtronic Physio-Control Corp.
Preface
Preface
DECLARATION OF CONFORMITY
according to EN 45014
Manufacturer’s Name: Medtronic Physio-Control Corp.
Manufacturer’s Address: 11811 Willows Road NE
P.O. Box 97006
Redmond, WA 98073-9706
USA
declares that the CE-marked product
Product Name:
LIFEPAK
®
500 automated external defibrillator
Model Number: 3005400 (monophasic)
3011790 (biphasic)
complies with 93/42/EEC (Medical Device Directive) Class Ilb, conformity assessed per Annex II.
Safety: EN60601-1:1996/ IEC 60601-1:1995
internally powered, Type BF, Continuous operation.
IEC 60601-2-4:1983
EMC: EN60601-1-2:1993/IEC 60601-1-2:
EN 55011:1991- Class B, Group 1
EN61000-4-2 1st edition - 8kV CD, 15 kV AD
IEC61000-4-3 1st edition - 3 V/m
EN61000-4-4 1st edition - Not Applicable
IEC61000-4-5/EN61000-4-5 1st edition - Not Applicable
Supplementary Information:
Included are the following accessories and interconnecting cables:
QUIK-COMBO
™
electrode set, PN 806086, 3008997, 3008826 or
3010188-001
FAST-PATCH
®
electrodes, PN 3006292 or 3010188-002
FAST-PATCH
®
defibrillation cable, PN 3010493
Sealed lead-acid battery, PN 3005379
Lithium battery, PN 3200390, 3005380
Battery Charger (non-medical), PN 3006535
Data transfer cable (non-medical), PN 3005381
Infant/Child Reduced Energy Defibrillation Electrodes
(specially configured biphasic AEDs only), PN 3202380
This product also complies with:
UL 2601-1:1994,
CSA C22.2 No. 601.1 and CSA C22.2 No. 601.2.4,
AAMI ES1, AAMI DF39
Redmond, January 28, 2003
Michael D. Willingham
Vice President of Quality and Regulatory Affairs
European Contact: Your local Medtronic Physio-Control Sales and Service Office or
Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen,
The Netherlands