Classification - AirSep Focus Portable Patient Manual

Classification

Type of protection against electric shock:
Class II Protection from electric shock is achieved by double insulation.
Degree of protection against electric shock:
Type BF Equipment providing a particular degree of protection against electric shock regarding
1) allowable leakage current;
2) reliability of protective earth connection (if present).
Not intended for direct cardiac application.
Independent testing for Medical Electrical Equipment Standard:
Tested by QPS Testing Services NA Inc. to be in compliance with,
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
2nd edition 1988, A1 1991, A2 1995.
Tested by QPS to be in compliance with applicable requirements of the Standard,
CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment – Part 1: General
Requirements for Safety, General instruction No. 1; Supplement No. 1; 1994
Amendment 2 – 1998 and General instruction No. 2 November 2003
Protection against potential electromagnetic or other interference between the equipment and other devices.
Tested by Ultratech Group of Labs to be in compliance with:
EN 60601-1-2:2007 (EMC) (2nd Edition), Medical Electrical Equipment, Part 1: General Requirements for Safety-
Collateral Standard: Electrical Compatibility - Requirements and Tests
RTCA-DO160F Airborne Equipment, Sec. 21, Emission of Radio Frequency Energy
CISPR 11:2004 / EN 55011:1998 +A1:1998 & A2:2002, Class B Group 1, "Industrial, Scientific, and Medical (ISM)
Equipment"
FCC Part 15, Subpart B – Class B Unintentional Radiators
Method of cleaning and infection control allowed:
Please refer to "Cleaning, Care, and Proper Maintenance" section of this Focus Patient Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suited for such application.
Mode of operation:
Continuous duty.
MN170-1 rev A 03/11
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