Stryker SERFAS - Powering On the System; Modes of Operation; CUT MODE; COAG MODE

CONFORMANCE TO STANDARDS
● 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
● 60601-1-2, Medical Electrical Equipment: Electromagnetic Compatibility Requirements and Tests
● 60601-1-4, Medical Electrical Equipment: General Requirements for Programmable Electrical Medical
Systems
● 60601-2-2, Medical Electrical Equipment: Particular Requirements for the Safety of High Frequency Surgical
Equipment
CLASSIFICATION
● Type of protection against electrical shock
• Class I Equipment
● Degree of protection against electrical shock
• Type CF Defibrillation-Proof Applied Part
● Degree of protection against harmful ingress of water
Generator:
• IEC 60601-1: Ordinary Equipment
• IEC 60601-2-2: Requirement per clause 44.3
Footswitch:
• IPX7 Water-tight Equipment
• IEC60601-2-2: Requirement per clause 44.6
● Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous
oxide.
PRODUCT CLASSIFICATIONS
21
(115 V units only)