Light,oper.room,LED,ceiling,w/access

GENERAL DESCRIPTION
Ceiling-mounted LED surgical light.

INTENDED USE
Surgical lights illuminate the surgical site for optimal visualization of small, low-contrast objects at varying depths in incisions and body cavities. Because hands, heads, and instruments can intrude over the surgical field, these lights are designed to reduce shadows and minimize colour distortion. They are also intended to operate for extended periods of time without radiating excessive heat, which could cause discomfort or dry tissues at the surgical site.

TECHNICAL SPECIFICATIONS
Single light head with LED lights in cluster that rotates in all three axes.
Ceiling-mounted suspension includes two articulating arms.
Focal length adjustable between 70 and 140 cm.
Maximum illumination of at least 120,000 lux at 1m.
Colour temperature between 3000°K and 5000°K.
Minimum colour rendering index (CRI) of 92.
Minimum LED life of 50,000 hours.
360° horizontal turning.
Vertical adjustment range of at least 95 cm.
The unit is equipped with an on/off switch and controls to adjust light intensity.
Adjustable field of view up including at least 0.15 - 0.25 m range.
Dimming function with a minimum of 10 settings.
Sterilizable and removable light handle for positioning.
Power requirements: 100 - 240 Volts - 50/60 Hz.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English. (French and Spanish can be made available on request).
1 x ceiling anchoring and fixation materials.
2 x spare sterilizable and removable handle.

ESTIMATED LIFE SPAN
10 year or the lifetime of the LEDs, whichever comes earlier.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 40°C / 30% – 75 % RH.
- Storage conditions: -20°C - 50°C / 10% – 75 % RH.
- Atmospheric pressure: 700 ~ 1060 hPa.

WEIGHT AND VOLUME (packaged)
Weight: 70.00 kg.
Volume: 864.00 dm³.

ESTIMATED DELIVERY LEAD TIME
100 days.

INSTALLATION REQUIREMENTS
Assembly and commissioning this product should be carried out by qualified technician.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

RELATED PRODUCTS:
S0002023 Light,examination,mobile,LED,w/access.

ALTERNATIVE PRODUCTS:
S0002023 Light,examination,mobile,LED,w/access.
S0002070 Light,oper.room,LED,mobile,w/access.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class I device.

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-41:2009+AMD1:2013 Medical Electrical Equipment, Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis.

NOMENCLATURE
- GMDN code: Light system, surgical (37332).
- UMDNS code: Lights, Surgical, Ceiling-Mounted (33268)