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OTOSCOPE, halogen + SPECULA

https://unicat.msf.org/cat/product/13628
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Former Code(s): -X
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
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

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. Supplemental devices (e.g., additional specula, spare light bulbs) may be included.

This is a reusable device.

Specifications

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Technical specifications

  • Handle, for 2 AA batteries
  • Screw-on head
  • Pivoting observation window, with triple enlargement, giving an excellent image
  • Halogen bulb 2.5V (HEINE XHL110, Riester HL10590)
  • 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
  • Supplied with 1 spare bulb

Packaging & Labelling

Delivered in a soft (nylon) case with instructions for use.

Instructions for use

Do not forget to remove the batteries after use.

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

Note

  • Speculums are interchangeable between the 2 brands (Heine and Riester): same code for ordering
  • Bulbs are different between the 2 brands: 1 code for Heine spare bulb, 1 code for Riester spare bulb

Maintenance

The specula must be cleaned and disinfected after each examination.

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