Classification - AirSep FreeStyle Patient Manual

EN

Classification

Type of protection against electric shock:
Class II
Degree of protection against electric shock:
Type BF Equipment providing a particular degree of protection against
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 anesthetic
gases:
Mode of operation:
EN-46
Protection from electric shock is achieved by double
insulation.
electric shock regarding
1) allowable leakage current;
2) reliability of protective earth connection (if present).
Not intended for direct cardiac application.
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
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
Please refer to "Cleaning, Care, and Proper Maintenance"
section of this FreeStyle Patient Manual.
Equipment not suited for such application.
Continuous duty.
FreeStyle™
®
AirSep Corporation
MN131-1 rev. B - 02/13