AirSep Freestyle Service Manual download pdf (Page 12)

irSep Corp.

—

FreeStyle Service Manual

1-6

1.6 FreeStyle Classifications

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 to be in compliance with:

IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety

Tested to be in compliance with applicable requirements of the Standard,

CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment – Part 1: General

Requirements for Safety

Protection against potential electromagnetic or other interference between the equipment and other

devices:

Device with accessories tested to be in compliance with

EN 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety-Collateral

Standard: Electrical Compatibility - 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 – Class B Unintentional Radiators

Method of cleaning and infection control allowed:

Please refer to the “Cleaning, Care, and Proper Maintenance” section of this FreeStyle

Service Manual.

Degree of safety of application in the presence of flammable anesthetic gases:

Equipment not suitable for such application.

Mode of operation:

Continuous duty.

1 2 ... 7 8 9 10 11 12 13 14 15 16 17 ... 68 69

No comments

AirSep Freestyle Service Manual Page 12