Classification - AirSep FreeStyle Patient Manual

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 by Intertech Testing Services NA Inc. to be in compliance with EN 60601-1:1988 + A1:1991, A2:1995
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 EN60601-1-2: 2001 Edition (EMC)
Method of cleaning and infection control allowed:
Please refer to the "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 suitable for such application.
Mode of operation:
Continuous duty.
28