AirSep MN172-1 - Manual (Page 229)

Focus™
EN
AirSep
®
Corporation EN-41
MN172-1 rev. A - 02/13
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).
3) 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
Ŕ Part 1:
General Requirements for Safety
Tested by QPS to be in compliance with applicable
requirements of the Standard, CAN/CSA C22.2
No. 60601-1-08 M90 Medical Electrical Equipment
Ŕ Part 1:
General Requirements for Safety
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 Medical Electrical Equipment, Part 1: General
Requirements for Safety-Collateral Standard: Electrical
Compatibility
Ŕ Requirements and Tests
RTCA-DO160 Airborne Equipment, Sec. 21, Emission of
Radio Frequency Energy CISPR 11 / EN 55011 Class B
Group 1, “Industrial, Scientific, and Medical (ISM) Equipment”
FCC Part 15, Subpart B
Ŕ 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.