Flashlight,pre-focused

GENERAL DESCRIPTION
Medical-grade pen light, pre-focused

INTENDED USE
Diagnostic pen light, generally used to check patient’s pupils.

TECHNICAL SPECIFICATIONS
Reusable model.
Durable, sturdy plastic or metal housing.
Compact design easily fits in breast pocket; designed with pocket clip.
Equipped with LED for high intensity light.
Diameter: 12.5 and 15mm.
Length: 127 and 134mm.
Mechanical switch, which should prevent accidental activation.
Suitable for single use or rechargeable batteries: AAA size
Is able to withstand frequent cleaning and disinfecting with hospital grade products.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x set disposable alkaline batteries

SHELF LIFE
Not applicable.

ESTIMATED LIFE SPAN
Three to ten years.

WARRANTY
Between one and two years depending on the supplied model.

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 50°C / 85% RH.
Operating conditions: 10 - 40°C / 85% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 49 gr.
Volume: 0.45 dm³.

INSTALLATION / COMMISSIONING REQUIREMENTS
Other than installing the battery there are no installation or commissioning requirements.

TRAINING REQUIREMENTS
No user training is required.

MAINTENANCE/USER REQUIREMENTS
Other than cleaning in accordance with manufactures instructions there are not specific maintenance requirements.

COMPONENT OF A KIT
No.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
Self-declared CE under the EU MDR 2017/745 as Class I device.