AirSep MN179-1 B - Manual (Page 12)

MN179-1 _ 02/14 AirSep Corp. - FreeStyle 5 Service Manual Rev B
1.5 FreeStyle 5 Classifications
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. 60601-1-08 M90 Medical Electrical Equipment
Protection against potential electromagnetic or other interference between the equipment and other devices.
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 “Cleaning, Care, and Proper Maintenance” section of this FreeStyle 5 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.