S0002070

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


Surgical light, LED, mobile, AC and battery powered.
Indicative Price 2,940.76 USD

GENERAL DESCRIPTION
Mobile surgical light, LED, with articulating arm and back up battery.

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.
Adjustable field of view including at least 0.17 - 0.30m range (depending on the model supplied).
Focal length of at least 0.7 m.
Maximum illumination of at least 120,000 lux at 1 m.
Colour temperature between 3000°K and 5000°K.
Colour rendering index (CRI) of 95.
Sterilizable and removable light handle for positioning.
Minimum LED life of 50,000 hours.
Minimum of 100° horizontal turning.
Articulating arm between light and base stand.
Base with at least four (4) anti-static swivel castors in a star formation.
A minimum of two (2) castors are equipped with brakes.
Heavy base with low centre of gravity, indicate weight of base relative to total device weight.
Floor to light height adjustable to include at least range of 1.1 m to 2.12 m.
On/off switch, battery status indicator (depending on model) and controls to adjust light intensity.
Dimming function with a minimum of 5 settings or fully adjustable.
Built in backup rechargeable battery with minimum 3 hours of battery life, battery type lead-acid.
Automatic switch from mains to batteries in case of power failure.
Power requirements: 100 - 240 Volts - 50/60 Hz.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
2 x Spare sterilizable handle.

ESTIMATED LIFE SPAN
Eight years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 30°C / 30% – 75% RH.
- Storage conditions: -10°C - 50°C / 20% – 90% RH.
- Atmospheric pressure: 700 ~ 7060 hPa.

WEIGHT AND VOLUME (packaged)
Weight: 88.00 kg.
Volume: 587.88 dm³.

ESTIMATED DELIVERY LEAD TIME
120 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.

ALTERNATIVE PRODUCTS:
S0002023 Light,examination,mobile,LED,w/access.
S0002071 Light,oper.room,LED,ceiling,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 IIa 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 60601-2-41:2009+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, Stand-Alone (332650).
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