1 Functional Requirements
The unit is intended to provide optimum homogeneous illumination of the surgical site in the operating theatre. The design of the light shall be LED technology, easy to handle, to control and to clean, fail-safety type, shadow-free and Infra-Red free light type.
2 Electrical Requirements
The system shall be equipped with power supply units, directly operable from the hospital standard electrical supply.
The system operating voltage shall be 24 V d.c switching power supply type. The unit shall come with watch-dog circuitry and equipped with no-load, overload and short-circuit protection devices to prevent damages to any system components. Each light head shall equip with its own individual power supply.
The system shall equip with auto-switchover circuitry to cater for UPS or standby source. The system shall operate directly on 100 – 230V + 10%, 50 Hz / 60 Hz + 2 Hz, single phase A.C. supply and power consumed shall not exceed 200W per light head.
3 Safety & Standards Requirements
The system shall conform to appropriate EC directives for Electrical safety and EMC requirements. All associated components shall carry the CE marking on them.
The system shall fully conform to the following:- a.
b.
IEC 60601-1 or its equivalent;
IEC 60601-1-2 or its equivalent; c.
d.
IEC 60601-2-41 or its equivalent;
IEC 60364-7-710 or its equivalent; e.
EN 55015:2000 + A1 or its equivalent; f.
g.
EN 61547:1995 + A1 or its equivalent; and,
International Safety & Quality Standards or its equivalent.
For safety reasons and to prevent overheating, no auto-transformer must be used and switching power supply is preferable. In event of power failure, the system shall be automatically switched over to UPS or battery backup provided by the Hospital.
The tenderer shall engage a professional structural engineer to certificate and endorse on the shop drawing prior to the commencement of the installation work. All cost shall be borne by the tenderer.

4. G e n e r a l R eq u ire me n t s
- The operating light must be designed for the use in high demanding surgical procedures. State-ofthe-art LED bulbs are used to ensure a low energy consumption and a long service life.
- Revolving outer handles at the light head allow for non-sterile positioning.
- Lighthead design with smooth transitions and surfaces, without slots, gaps or exposed screwing allows for fast and effective cleaning.
- The lighthead with streamlined shape is favorable within laminar flow. The lighthead is resistant to disinfectant.
- Sterile positioning via an ergonomic, exchangeable and centrally positioned sterile handle within the light head.
- Disinfectant resistant, impact-proof light emitting surface. Use of materials with best properties for heat conduction.
- OR light with 2 light heads fixed to a ceiling substructure fixation, central axis with horizontal swivel arms in various length and height adjustable spring load arms.
- All main joints for light heads with unlimited rotation (>360°). Light head and suspension dustproof sealed.
- For visualization of the surgical procedure the light system should be able to be equipped with a video camera system for future upgrade.
- To show the picture recorded by the video camera system, the light system should be able to be combined with a medical grade 21 inch display monitor when video camera system is in used in the future.
Complete with all components for ceiling mount and electrical feed-in, incl. finalised installation.
The system shall be ceiling-mounted on a single point suspension system, consisting of both the main and satellite light head. The system shall provide flicker-free, shadow-free cool light. All arms with light heads are freely rotatable (without stops) at all vertical joints. All power supply shall be embedded within the arms and slip rings in all vertical joints. One of the light heads to be cable ready for video system, whereby video transmission in the hospital network for video conferencing or telemedicine can also be implemented when needed. (Refer to Optional Items)
The system shall be of robust construction, easy to clean and protected against ingress of water and dust. No ventilation slots shall be allowed. The finish shall be rust-proof, resistant to fungal growth and easily cleaned by common hospital disinfectants. The system light head shall be dust proof and splash proof type.
The system shall allow for vertical, horizontal and axial motion to be capable of smooth, accurate and steady positioning. Once positioned, there shall be a system to lock the light head in place and the arm shall not be allowed to drift.
The removable and sterilizable positioning handles shall be easy to remove and insert and shall not, under any circumstances, becomes loose.
Single light source device replacement shall be quick and easy. Such single light source replacement shall not be done periodically. All light source device shall be made of energy efficient devices.
The system shall be able to change the light intensity. The system shall have a memory function, able

to restart with the same light intensity which was used before switch off. All controlling function is preferable to be located at the light head and optional in addition at the wall.
Main and Satellite Light
Technical data:
Central illumination in 1 m distance
Fieldsize adjustment from - to
Color temperature more then
Color rendering-index R a
Central illumination at 1m distance with:
tube:
one mask:
tube and one mask:
Depth of illumination L1+L2
Sterile control of field size via sterile handle
Illumination intensity adjustable
Control of illumination intensity via wall control panel
Control of illumination intensity via control panel on cardan joint
Integration into integrated OR-systems via RS 232 interface possible energy efficiency Ee
Ee/Ec ratio photometric radiation equivalent light-emitting surface
Light source type bulb type
Power consumption of light sources
Lifetime of light sources
Service/Exchange concept for light sources
Replacement of single LED bulbs
Required
110.000 lux+0/-20%
220-290 mm
4.500 K
93+/-2%
99%
45-60%
45-60%
1300 mm+/-200mm
Yes
40% - 100%
Yes
Yes
Yes
320-340W/sqm
3.43.6 mW/m²xlux
270-290 lm/W
>280 cm²
LED
Warm white max. 60 W
30.000 h
Yes
Hygienic characteristics according to norm DIN/EN
1946-4
Annex D Turbulence intensity measurement
Certification available
The standard accessories shall be included the following items: a) 3 x removable, autoclavable positioning handles; b) 2 x service and operator manuals. c) 2 x set of LED replacement bulbs for each light head offered passed
Yes
.