AirSep Focus Manuel page 184

Focus™
Classification
Typ
e of protection against electric shock:
Class II
Degree of protection against electric shock:
Type BF
Independent testing for Medical Electrical Equipment Standard:
Protection against potential electromagnetic or other interference between the
equipment and other devices.
Method of cleaning and infection control allowed:
Degree of safety of application in the presence of flammable anaesthetic gases:
Mode of operation:
®
AirSep Corporation
MN172-1 rev. - 03/11
Protection from electric shock is achieved by double insulation.
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.
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
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
Please refer to "Cleaning, Care, and Proper Maintenance" section of
this Focus Patient Manual.
Equipment not suited for such application.
Continuous duty.
GB
GB-32