Torchlight, ophthalmic

GENERAL DESCRIPTION
Diagnostic penlight validated for medical examination of the pupil.

INTENDED USE
Diagnostic pen light for use by healthcare professionals to examine patient’s pupils.

TECHNICAL SPECIFICATIONS
Torchlight in the shape of a pen, with click on/off switch.
Compact design easily fits in breast pocket and includes a pocket clip.
Photobiologically validated for pupil illumination (EN 62471 compliant).
Light source: high-performance LED, 2.5V, 5000-5500K.
Light intensity: up to 180,000 lux.
Field of illumination: approx. 11cm at 15cm distance.
Suitable for use with 2 alkaline AA batteries.
Comes with integrated tongue depressor holder.
Disinfectable ABS casing.

SUPPLIED WITH
Instructions for use and maintenance in English, French and Spanish.
1 x Anti-scratch storage case.

SHELF LIFE
Not applicable

ESTIMATED LIFE SPAN
10 years

WARRANTY
2 years

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 40C/ 10 to 95% relative humidity (non-condensing)
Storage conditions: -10 to 55C/ 10 to 95% relative humidity (non-condensing)

WEIGHT AND VOLUME
Weight: 0.123kg
Volume: 0.552dm3

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.

REGULATION & CONFORMITY REQUIREMENTS
CE-marked Class I medical device, self-declared under EU MDR 2017/745.
US FDA device listing as a Class I medical device (510(k) exempt).

SAFETY & PRODUCT STANDARDS
IEC 60601-1, IEC 60601-1-2, ISO 15004, EN 62471

NOMENCLATURE
GMDN©: 38832