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A surgical light – also referred to as an operating light or surgical lighthead – is a medical

device intended to assist medical personnel during a surgical procedure by illuminating a local area or
cavity of the patient. A combination of several surgical lights is often referred to as a “surgical light
system”

Historical Profile:
In the mid-1850s, operating rooms were built towards the southeast with windows in the ceiling to
benefit from natural sunlight as much as possible. The biggest problem was the dependence of
lighting and whether a procedure could be done on the time of day and weather conditions.
Furthermore, a doctor, nurse or medical equipment easily blocked the light. The use of mirrors on the
four corners of the ceiling to reflect sunlight towards the operating table only slightly alleviated these
problems. Attempts were made to use an optical condenser in an indirect light to reduce the heating,
but without success. The entrance of electric lights into the operating room in the 1880s was
accompanied by problems. With early electrical technology control of the light emitted was poor.
Electric light was still moving and diffuse, with great heat radiation. Light-emitting diodes as light
sources remove the problem of heat radiation and reduce energy requirements. A surgical light – also
referred to as an operating light or surgical lighthead – is a medical device intended to assist medical
personnel during a surgical procedure by illuminating a local area or cavity of the patient. A
combination of several surgical lights is often referred to as a “surgical light system”.

Terminology and measurements:

Lux: Unit for the amount of visible light measured by a luxmeter at a certain point.
Central illuminance (Ec): Illuminance (measured in lux) at 1m distance from the light emitting
surface in the light field centre. Light field centre: Point in the light field (lighted area) where
illuminance reaches maximum lux intensity. It is the reference point for most measurements.
Depth of illumination: The distance between the points of 20% illumination intensity above and
below the center point. From the point of maximum illumination, which is the center of the light field
1 meter from the light-emitting surface, the photometer is moved toward the light until the light
intensity measured falls to 20% of the maximum value. The distance between the center and this point
is defined as L1. The similarly measured distance in the direction away from the light is L2. The
depth of illumination without needing to refocus is the sum of the two distances L1 and L2. In the
second edition of the IEC standard, published in 2009, the threshold value was revised from 20% to
60%.
Shadow dilution: The light's ability to minimize the effect of obstructions.

Name: Ms. Swati Tiwari Roll Number: 16105A0055

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Light field diameter (D10): Diameter of light field around the light field centre, ending where the
illuminance reaches 10% of Ec. The value reported is the average of four different cross sections
through the light field centre.
D50: Diameter of light field around the light field centre, ending where the illuminance reaches 50%
of Ec. The value reported is the average of four different cross sections through the light field centre.

Technical Specification
1. Should have Single Colour high performance LEDs with life time more than 40,000 hours.
2. Should be a dual dome and the main light and satellite should have the following specifications a.
LUX intensity 1,40,000 Lux & Satellite 1,40,000 Lux or above. b. Light Field diameter shall be above
24 cm or better. c. Colour temperature should be between 4000 to 4500 degree K d. Colour rendering
index should not be less than 95 e. Depth of illumination should not be less than 100 cm. f.
Illumination adjustment 30% to 100% g. The light dome shall be compatible for laminar air flow.
3. Should have stable illumination throughout the life period of the light. If the intensity reduces
during the warranty or CMC period the LEDs has to be replaced at free of cost if required.
4. The LED’s must be of a single color suitable for long term maintenance and ease of replacement.
5. Temperature rise at the surgeon head level should be less than 2 degree C. 6. Should have control
panel for light focusing adjustment fixed on the dome or arms. 7. Should supply autoclavable handle 3
Nos. for each dome
8. Unit should function with 200-240Vac, 50/60 Hz input power supply.
9. Should have safety certificate from a competent authority CE / FDA (US) / STQC CB certificate /
STQC S certificate or valid detailed electrical and functional safety test report from ERTL. Copy of
the certificate / test report shall be produced along with the technical bid.
10.The intensity of light from each dome should be uniform during the surgery.

Norms and requirements for surgical light

The International Electrotechnical Commission (IEC) created the document IEC 60601-2-41 –
Particular requirements for the basic safety and essential performance of surgical luminaires and
luminaires for diagnosis, 2009 to establish norms and guidelines for the characteristics of a surgical
and examination light to secure safety for the patient as well as lower the risk to a reasonable level
when the light is used according to the user manual. Some of the standards for surgical lightheads are
the following: Homogenous light: The light should offer good illumination on a flat, narrow or deep
surface in a cavity, despite obstacles such as surgeons' heads or hands. Lux: The central illuminance
should be between 160,000 and 40,000 lux. Light field diameter: The D50 diameter should be at least
50% of D10. Colour rendition: For the purpose of distinguishing true tissue colour in a cavity, the
colour rendering index (Ra) should be between 85 and 100. Backup possibility: In case of interruption
of the power supply, the light should be restored within 5 seconds with at least 50% of the previous
lux intensity, but not less than 40,000 lux. Within 40 seconds the light should be completely restored
to the original brightness. Announcement: The IEC document also mentions what needs to be notified
to the user. For example, the voltage and power consumption should be marked on or near the
lampholder as well as on the lighthead.

Name: Ms. Swati Tiwari Roll Number: 16105A0055

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Name: Ms. Swati Tiwari Roll Number: 16105A0055

Page 3 of 3