1. Classification - AirSep FreeStyle Patient Manual

FreeStyle
™
XV. 1. Classification
Type of protection against electric shock:
Class II
Degree of protection against electric shock:
Type BF
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 anaesthetic gases:
Mode of operation:
AirSep Corporation
®
Protection from electric shock is achieved by double insulation.
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.
Tested by Intertech Testing Services NA Inc. to be in compliance
with EN 60601-1:1988 + A1:1991, A2:1995
General Requirements for safety.
Tested by Ultratech Group of Labs to be in compliance with
EN60601-1-2: 2001 Edition (EMC)
Please refer to the "Cleaning, Care, and Proper Maintenance"
section of this FreeStyle Patient Manual.
Equipment not suitable for such application.
Continuous duty.
GB
17-GB