Classifications And Approvals - Stryker SERFAS Manual Del Usuario

Classifications and Approvals

Complies with medical safety standards:
IEC 60601-1: 1998 + A1:1991 + A2:1995
AS 3200.1.0: 1998
IEC 60601-1-2: 2001
IEC 60601-2-2: 1998
UL 60601-1: 2003
CSA C22.2 No. 601-1-M90
Classification
Type of protection against electric shock
• Class I Equipment
Degree of protection against electric shock
• Type BF Defibrillation-Proof Applied Part
Degree of protection against harmful ingress of water
• Generator: IEC 60601-2-2: Requirement per clause 44.3
• Probe: IEC 60601-2-2: Requirement per clause 44.6
• Footswitch: IEC60601-2-2: Requirement per clause 44.6,
IPX7 Water-tight Equipment
Mode of Operation
• Continuous with intermittent probe activation
Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen,
or nitrous oxide.
EN-33