Light,examination,mobile,LED,w/access

GENERAL DESCRIPTION
Mobile examination LED light with articulating arm.

INTENDED USE
Examination lights directly illuminate specific areas of a patient's body during diagnostic procedures and general examination. These lights are intended to emit their useful radiation mainly in the visible spectrum. Examination lights may also be used during minor surgical procedures (e.g., minor cosmetic surgery).

TECHNICAL SPECIFICATIONS
Heavy base with low centre of gravity.
Single light head with LED lights in cluster.
Articulating arm between light and base stand.
Base with 5 anti-static swivel castors in a star formation.
At least two castors have been equipped with brakes.
Minimum 14 cm fixed focus field of view.
Minimum illumination of 60,000 lux at 0.5m.
Minimum colour temperature between 4,000°K.
Minimum colour rendering index (CRI) of 95.
Minimum LED life more than 40,000 hours.
Floor to light height adjustable to include at least range of 1.1 m to 1.75 m.
On/off switch.
Power requirements: 100 - 240 Volts - 50/60 Hz.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English.

OPTIONAL ACCESSORIES AVAILABLE
- An integrated rechargeable battery with a minimum of 2 hours battery life can be supplied upon request at extra cost.

ESTIMATED LIFE SPAN
10 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 30°C / 75% RH.
- Storage conditions: -10°C - 50°C / 75% RH.
- Atmospheric pressure: 700 ~ 1060 hPa.
- Ingress protection rating: IP20.

WEIGHT AND VOLUME
Weight: 13.4 kg
Volume 80.000 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
S0002070, Light,oper.room,LED,mobile,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 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: Medical Electrical Equipment, Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis.

NOMENCLATURE
- GMDN code: Mobile examination/treatment light (36843).
- UMDNS code: Lights, Examination (12276).