AirSep MN131-1 B - Manual (Page 258)

EN FreeStyle™
EN-46 AirSep
®
Corporation
MN131-1 rev. B - 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).
Not intended for direct cardiac application.
Independent testing for Medical Electrical Equipment Standard:
Tested to be in compliance with
IEC 60601-1 General Requirements for safety.
CAN/CSA C22.2 No. 60601-1-08 M90 Medical Electrical
Equipment – Part 1: General
Requirements for Safety
Protection against potential electromagnetic or other interference between the
equipment and other devices.
Tested to be in compliance with EN60601-1-2 (EMC).
Tested to be in compliance with RTCA/DO160 Section 21
Category M.
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 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.