Diagnostic pupil LED penlight.
Indicative Price 1.24 USD
Medical-grade pen light, pre-focused
Diagnostic pen light, generally used to check patient’s pupils.
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.
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x set disposable alkaline batteries
ESTIMATED LIFE SPAN
Three to ten years.
Between one and two years depending on the supplied model.
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.
No user training is required.
Other than cleaning in accordance with manufactures instructions there are not specific maintenance requirements.
COMPONENT OF A KIT
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.
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