Classification - AirSep Focus Manual Del Paciente

Focus™

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:
®
AirSep Corporation
MN172-1 rev. A - 02/13
Protection from electric shock is achieved by double
insulation.
electric shock regarding
1) allowable leakage current;
2) reliability of protective earth connection (if present).
3) Not intended for direct cardiac application.
Tested by QPS Testing Services NA Inc. to be in compliance
with, IEC 60601-1 Medical Electrical Equipment Ŕ Part 1:
General Requirements for Safety
Tested by QPS to be in compliance with applicable
requirements of the Standard, CAN/CSA C22.2
No. 60601-1-08 M90 Medical Electrical Equipment Ŕ Part 1:
General Requirements for Safety
Tested by Ultratech Group of Labs to be in compliance with:
EN 60601-1-2 Medical Electrical Equipment, Part 1: General
Requirements for Safety-Collateral Standard: Electrical
Compatibility Ŕ Requirements and Tests
RTCA-DO160 Airborne Equipment, Sec. 21, Emission of
Radio Frequency Energy CISPR 11 / EN 55011 Class B
Group 1, "Industrial, Scientific, and Medical (ISM) Equipment"
FCC Part 15, Subpart B Ŕ Class B Unintentional Radiators
Please refer to "Cleaning, Care, and Proper Maintenance"
section of this Focus Patient Manual.
Equipment not suited for such application.
Continuous duty.
EN
EN-41