GE MAC 600 SPY Service Manual page 115

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Technical Specification:
Certification
Class I, type CF defibrillator proof (for China shipments and for device serial number equal to or greater than SF713500001PA)
Class II, type CF defibrillator proof (for device serial number less than SF713500001PA excluding China Shipments)
UL 60601-1 Medical Electrical Equipment, part 1:General Requirements for Safety
CAN/CSA C22.2 No. 601.1 General Requirements for Safety
CE marking for Council Directive 93/42/EEC concerning medical devices
IEC 60601-1 General Requirements for Safety
IEC 60601-1-1 General Requirements for Safety Medical Electrical systems
IEC 60601-2-25 Particular Requirements for the Safety of Electrocardiographs
IEC 60601-2-51 Particular requirements for safety, including essential performance, of recording and analyzing single channel and multi
channel electrocardiographs.
IEC 60601-1-2 General Requirements for Safety Electromagnetic Compatibility.
IEC 60601-1-4 General Requirements for Safety – Programmable electrical medical systems
IEC 60601-1-6 General requirements for basic safety and essential performance – Collateral Standard: Usability-Edition 2.0
Meets applicable AAMI EC-11 requirements and AAMI EC 13 (Clause 4.2.7 only)
TM
Revision G
MAC
600
A-5
2047426-002

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