2 — A Word from STERIS
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11042437_A
LED202 In-Ceiling Lighting System Operator Manual
A Word from STERIS
2.1 Introduction
This manual contains important information on the proper operation of the LED202 Lighting System. All personnel
involved in operating this equipment must carefully review and comply with the warnings, cautions, and instructions
contained in this manual. These instructions are important to protect the health and safety of personnel operating the
LED202 Lighting System and should be retained in a conveniently accessible area for quick reference.
Complete instructions for uncrating, installing and maintaining this unit, as well as equipment drawings, have been
furnished. If missing, contact STERIS for replacement copies, giving the serial, equipment and model numbers of the
unit.
2.2 Indications for Use
Intended Use
The intended use of the LED202 Lighting System is to provide fixed pattern/variable intensity visible illumination of the
surgical/clinically relevant field and the patient.
The LED202 Lighting System suspension is a non-mobile flush-mounted ceiling mounted support system installed in a
surgical/clinical environment.
A single LED202 lighting fixture meets the requirement for a luminaire for diagnosis per IEC 60601-2-41.
Multiple LED202 lighting fixtures meet the requirement for a surgical luminaire system per IEC 60601-2-41.
The system expected life (i.e. service or useful life) is 10 years when subjected to the use profile as defined in Use
Profile.
Product User Profile
This device is intended to be operated by both sterile and non-sterile surgical staff.
Use Profile
System usage is defined as 10 hours (or 5 procedures) per day, 6 days per week, 51 weeks per year.
2.3 Advisory
The following is an important message from STERIS about the advantages and limitations associated with the use
of high intensity surgical lighting systems.
Because of the variety of surgical procedures performed and the wide range of individual preferences of surgical staffs,
it is desirable that a surgical lighting system be capable of selective control across a wide range of illumination
intensities. The Illuminating Engineering Society (IES) stresses that in addition to providing control of intensity, surgical
lighting systems should provide shadow control, correct color rendition, and a suitable depth of field to provide sharp,
consistent lighting into deep body cavities. As illumination levels increase, however, radiant heat also increases.
Therefore, the IES cautions that for most operations, radiant heat should be kept to a minimum. The user of surgical
lights should utilize the lowest possible illumination level suitable for the procedure, especially in certain neurological or
intestinal procedures on delicate, thin, dry or abnormal tissue. Furthermore, for the protection of surgically exposed
tissues and for the comfort and efficiency of the surgeon and assistants, radiant energy can be effectively controlled by
limiting the time of exposure at higher illumination levels. Extra care must be taken when the light fields from multiple
lightheads are overlapped on the surgical site, since this condition creates a risk of too much heat and excessive UV
irradiance.
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