Operating lights are designed to provide safe and uniform illumination of the operating field or patient,
but unfortunately there are recent examples of reports of thermal skin injuries when using operating light
systems. It is important to remember that when using all operating lights on the market, many factors can
contribute to an increased risk of thermal injury to the skin, organs and tissues. The risk increases during
a long procedure, as well as when there are multiple LED operating lights set to high intensity close
together. Thermal injuries can include skin burns and dry tissues, which in turn can lead to scarring,
infection, and/or damage to internal organs. Recently, Baxter has m.in received a number of reports of
severe injuries related to this issue.
Please note that users should use operating light systems by following the cautions and warnings in the
current Operating Instructions (IFU) and taking into account the additional information presented below.
1. Use the lowest possible light intensity appropriate for the procedure, especially for certain
neurological or bowel procedures that are performed on fragile, thin, dry, or abnormal tissues.
• Avoid overlapping of high-intensity light fields (80% or more).
• If the light intensity of one paw is set to 100% or more, then in the case of overlapping
of the other field, its intensity should be set to 40% or less (or, for example, 80% and
50%).
• If the light intensity of two or more lap lights is set to 80% or more, their fields should
not overlap to minimize the risk.
• If a very high intensity setting is temporarily required, it should be reduced when it is no
longer required.
Following these recommendations is crucial, because even single operating lamps emit high irradiance E
total of up to 700W/m2 for maximum illuminance Ec – examples of radiation values of operating lamp
bowls:
- Baxter ILED7 – for Ec 160kLux illuminance, total E irradiance : 623W/m2
- Maquet PowerLED II or Volista – Boost function 160k E total 600 W/m2
- Maquet G8 – 150 kLux , Ee=520 W/m2
- Dr Mach 8MC – Ee = 694W/m2 at maximum illuminance.
- Drager Polaris 600 – 160kLux Ee 600W/m2
The lamps manufactured by Infimed Sp. z o.o. do not differ from the above-mentioned values – model
PROXY OL-03 – for the illuminance Ec 160kLux, the irradiance Ee<570 W/m2 (at a distance of 1 meter), but
when the lamp head is brought closer to the illuminated field, it increases to a maximum of E total 690W/m2.
The standards currently applicable to manufacturers of operating lamps, especially the specific standard:
EN 60601-2-41:2021 Medical electrical equipment - Part 2-41: Particular requirements for the
basic safety and essential functioning of surgical and diagnostic devices
specify the requirements for the technical parameters of operating lamps. In clause 201.4.3, EN 60601-2-
41:2021 specifies that the maximum irradiation E total must not exceed 700 W/m2 for a single luminaire. In
the previous version of the standard from 2009, this value was over 40% higher and amounted to 1000
W/m2, but it was lowered in order to better protect tissues exposed to thermal risk (description in Annex
AA of the standard, point 201.10.101.1.3).
It should be remembered that each lamp set consisting of two (or more) bowls can generate irradiance
above 1000W/m2 (at maximum Ec), which we warn about in the IFU – in our case it can be found in point
1.2 General notes on safe use of the product in the Proxy lamp User Manual.
Operating lights are a medical device intended for use in hospitals by a professional user after training and
reading the User Manual. Due to a number of hazards (including thermal hazards), users should use
operating light systems carefully, following the above-mentioned warnings and warnings, because the risk
can never be reduced to zero. LED operating lamps are certainly a much better and safer solution than
older technological discharge or halogen solutions, but they also emit thermal irradiation, increasing with
the intensity of illumination. We can also see the tightening of safety parameters in subsequent editions
of standards for European manufacturers, but until the next technological breakthrough in light sources
and the development of a safer solution, thermal hazards will be one of the main threats.
