Classification - AirSep FreeStyle Patient Manual

Classification

Type of protection against electric shock:
Protection from electric shock is achieved by double insulation.
Class II
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 Intertek Testing Services NA Inc. to be in compliance with IEC 60601-1:1988 + A1:1991, A2:1995
General Requirements for safety.
Tested by Intertek to be in compliance with applicable requirements of the Standards, CAN/CSA C22.2 No.
601.1 M90 for Medical Electrical Equipment.
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).
Tested by Ultratech Group of Labs to be in compliance with RTCA/DO160D Section 21 Category M.
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.
MN123-1 rev B 01/10
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