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OTOSCOPE, LED, FO, + reusable SPECULA

https://msf.oodin.sh/cat/product/97034
STD EMEQOTOS3LF

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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.
Z12149006 - Direct outpatient otoscopes
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.
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In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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DIRECT OTOSCOPE, LED, Fiber Optic

Definition

A battery-powered, hand-held, device primarily designed for examining the outer ear canal and tympanic membrane by direct viewing through the ear opening during ENT treatments.

The device consists of a handle that contains the batteries, a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal.

This is a reusable device.

Specifications

The light source of an otoscopes: different options:

technology of the bulb:

  • Halogen bulbs are bright and give off a bluish-white color. These bulbs also are considered fairly cool as they do not generate much heat during illumination.
  • Xenon bulbs are a little brighter, emit more of a white light, and burn warmer than Halogen.
  • LED bulbs burn the brightest and whitest while staying cool during use.

the manner in which the light source is illuminated:

  • direct illumination: the bulb is located above the floor of the eyepiece so that the light can be directed through the speculum's opening.
  • fiber optic technology delivers the bulb's light via fiber optic bundles located around the perimeter of otoscope head where the speculum is attached.

Technical specifications

  • Handle, for batteries
  • Screw-on head
  • Observation window, with triple enlargement, giving an excellent image. Can be rotated 360 °, 180 ° for instrument interventions through the open otoscope
  • LED bulb 3.7 V, 52 mA mean life span 20,000 h
  • Fiber Optic illumination
  • Set of minimum 4 reusable specula
    • min 2 different sizes: adult and pediatric (Ø: going from 2/2.5 mm to 5 mm)
    • painless and non traumatizing insertion
    • solid fixation onto the otoscope
    • autoclavable

Packaging & Labelling

Delivered in a case / pouch with instructions for use.

To be Ordered Separately

2 Alkaline AA 1.5 V batteries

Instructions for use

Do not forget to remove the batteries after use.

Always put the complete otoscope back in its case to prevent damage.

Maintenance

The specula must be cleaned and disinfected after each examination.

Storage

Storage/ Transport Ambient temperature -10 °C to 55 °C

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