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OPHTALMIC/OTOLOGIC SET (Arclight)

https://unicat.msf.org/cat/product/93636
NST EMEQOPOT2--

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CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z12120114 - Ophthalmoscopes
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
UN3481
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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OPHTALMIC/OTOLOGIC SET (Arclight SET)

Definition

The Arclight is a multi-purpose solar-powered diagnostic tool that combines a direct ophthalmoscope, anterior segment loupe and otoscope (as well as a number of other functions) into a small highly portable device

It comes in a case with a 3-metre visual acuity chart, clip to attach to a mobile phone camera to capture clinical signs, lanyard, speculae and a USB charging lead

Specifications

An all-in-one compact and easy-to-use ophthalmoscope-loupe-otoscope for healthcare professionals of all levels.LED – crisp and reliable illumination

  • Blue light – for corneal exams
  • Corrective lenses Anterior segment magnifying loupe
  • Dual charge – solar panel & USB C
  • Ear speculae convert to an otoscope
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Technical specifications

  • Dimensions & Weight:
    • device – 110x24x9mm, 20g
    • fabric case and extras – 127x67x33mm, 83g
  • Materials: ABS, PC, PMMA, Silicone, Nylon
  • Illumination: LED – warm-white (ophthalmoscope), daylight-white (otoscope/loupe), blue
  • Logic Modes: 1) default general, 2) eye specialist, 3) ear specialist • Lenses: -3D, -6D, +4D
  • Specula: 4.5mm and 2.5mm
  • Battery & Charging: Li-Ion (enclosed). Solar and USB C

Supplied with the Article

Fabric Case:

  • 2x Specula
  • Lanyard
  • USB C Cable
  • Cloth Chart
  • Reading Chart
  • Video Clip
  • Instructions/online content

Instructions for use

Recommended use in conjunction with tropicamide eye drops (DEXOTROP5D4) to dilate pupils

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Precautions for Use

Proper study and training is essential.

Use clinical judgment: minimise light intensity and exposure.

Maintenance

Disinfect by wiping surfaces with alcohol. No user serviceable parts. Do not put in fluids or near flammable gases, use force, expose to high temperatures, or use if damaged.

MSF requirements

Easy to use handheld instrument to view the optic nerve or ear drum

Can be used for different indications/uses

  • fundoscopy (diabetes, HTN, TB, CMV, syphilis, )
  • red reflex (neonates/cataracts)
  • otoscopy
  • paediatrics/ IPD/ Critical care/ HIV/ NCD/ post-natal checks/etc
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Description approved by referent of OCB (Tom Ellman) in February 2025.