Nellcor OXIMAX N-560, Operator'S Manual

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Specifications
102
Compliance
Item Standard Description
Quality System EN ISO 13485: 2000,
ISO 13485: 1996 Quality system — Medical
Devices, Particular
Requirements for application
of ISO 9001: 2000
EC Directive 93/42/EEC Medical Device Directive
( Int.)
FDA Guidance FDA RG (Nov. 1993) Reviewers Guide for
Premarket Notification
Submission
Safety — EC EN 60601-1: 1995 General Rqmts for Safety,
Medical Equipment
Safety — USA UL 60601-1: 2003 Safety — Medical Electrical
System
Safety — Canada CSA C22.2 No 601,
1-M90: 1998 Safety — Medical Electrical
Sys, Requires NRTL Listing
Electric Shock
Classification EN 60601-1 Class I or Internally powered
(Battery mode), Type BF
Applied part
Protection against
Water Classification EN 60601-1 IPX1
Mode of Operation
Classification EN 60601-1 Continuous Operation
Flammable
Anaesthetic
Classification EN 60601-1 Equipment not suitable
Safety ISO 9919: 2005(E) Particular requirements for the
basic safety and essential
performance of pulse oximeter
equipment for medical use.
EMC EN 60601-1-2 Medical Electric Equipment,
Collateral Standard: EMC-
Requirements and Test, 2nd
Edition, 2001