Classifications - CAIRE FreeStyle Manual

FREESTYLE AND FREESTYLE 5 CLASSIFICATIONS
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 to be in compliance with:
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
Tested 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
Protection against potential electromagnetic or other interference between the equipment and
other devices.
Device with accessories tested to be in compliance with:
EN 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety-
Collateral Standard: Electrical Compatibility - 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 – Class B Unintentional Radiators
Method of cleaning and infection control allowed:
Please refer to the "Cleaning, Care, and Proper Maintenance" section of this Technical
Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suitable for such application.
Mode of operation:
Continuous duty.
Portable Oxygen Concentrator
MN220-1 B 11