Steris LED202 - Addresses

2 — A Word from STERIS
2
Operator Manual LED202 In-Ceiling Lighting System
11042437_A
An international standard for the safety of surgical lights established by the International Electrotechnical Commission
(IEC 60601-2-41) sets minimum and maximum levels of illumination and maximum levels of radiant heat that can be
emitted from a single surgical luminaire. The LED202 Lighting System has been designed to comply with this
international standard and to provide a wide range of illumination levels while minimizing the potentially damaging
infrared heat in the surgical field. The optical radiation emitted by this product complies with the exposure limits for
reducing the risk of photobiological hazards based in IEC 60601-2-41.
The illumination level of the light fixture can be adjusted through several intensity settings via the wall-mounted
controls.
A summary of the safety warnings and cautions to be observed when operating this equipment can be found in Section
3, Summary of Warnings and Cautions. Do not operate the lighting system until this information is understood.
The LED202 In-Ceiling Lighting System has been designed for the specific uses described in this manual.
Uses other than as specified and described are not recommended. Please contact a STERIS representative for
appropriate guidance, in-service, and training.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and
competent authority in the country where the incident occurred.
2.4 Addresses
STERIS Corporation
2720 Gunter Park East
Montgomery, AL 36109 • USA
334-277-6660/800-444-9009
www.steris.com
Class 1 Equipment
Ordinary Equipment (enclosed equipment without protection from ingress of water)
Equipment not suitable for use in oxygen-rich environment or in the presence of a flammable anesthetic mixture with
air or oxygen or nitrous oxide.
Suitable for continuous operation.
STERIS Corporation, Montgomery, Alabama is an ISO 13485 certified facility.
The base language of this document is ENGLISH. Any translations must be made from the base language document.
Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste. It must be
collected separately and must be disposed as per local regulations. Contact your authorized representative for
information concerning the decommissioning of your equipment.