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AESTHESIOMETER, monofilament, 10 g, size 5.07

https://unicat.msf.org/cat/product/69689
STD EMEQAESTM10

Valid Article

Former Code(s): EMEQOCBZLB0002 EMEQAEST2-- EMEQZFR0158
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.
V030207 - Sensitivity measurements devices not included in other classes
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
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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AESTHESIOMETER, monofilament

Definition

A manual stimulator designed to determine tactile sensation by patient response to the manual application of a thin filament to the skin. It typically consists of a filament with a pre-set flexibility and is intended to apply a known pressure upon application; the filament is attached to an appropriate handle/base that may also be intended to be loaded into a dedicated pen/holder. The device is used during diagnosis or treatment of nerve injuries and neuropathies associated with e.g., diabetes mellitus or leprosy. This is a reusable device.

Synonym

Semmes-Weinstein monofilament, diabetic monofilament

Specifications

Each filament will exert a specific, repeatable, force on the test site. The force exerted against the skin is a function of the length and diameter of the filament. This force remains constant, regardless the bend of the filament.

Technical specifications

  • Point aesthesiometer with one monofilament.
  • The monofilament is mounted on a holder and has a protection mechanism (retractable, folding into the holder or protective sheath) if not in use.
  • The monofilament can be replaced if needed (spare part, brand specific)
  • Monofilament is calibrated at 10 g = size 5.07
  • Monofilament material : nylon

Supplied with the Article

Spare monofilament

Instructions for use

  • Show the filament to the patient and touch it to his/her hand or arm so that he/she knows it does not hurt.
  • Use the 10 gram filament to test sensation at the indicated sites on each foot.
  • Hold the filament perpendicular to the skin and use a smooth motion when testing. Touch the skin until the filament bends in a letter ‘C' shape and then lift from the skin.
  • Ask the patient to close the eyes and say “yes” when the filament is felt.
  • Do NOT test directly on an ulcer, callus, scar or necrotic tissue, or very hard skin where sensation will be reduced
  • Do not use rapid movement. The approach, skin contact, and departure of the filament should be approximately 1.5 seconds in duration.
  • If the patient does not respond when you touch a given point on the foot, continue on another site.

For diabetes patients, lack of feeling at 4 or more out of 10 sites indicates a neuropathy.

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Precautions for Use

The same monofilament should not be used for more than 10 patients in 24 hours because of fatigue of the monofilament nylon fibres and a less accurate result.

Maintenance

It is recommended to disinfect the article after each use on a patient by using a non-alcoholic disinfectant.

Can be cleaned and disinfected with aa detergent/disinfectant solution for surfaces / non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

MSF requirements

Neuropathy screening by monofilament is important for identifying a ‘high-risk diabetic foot' and chronic poor glycaemic control, and should be performed at least once a year per patient.

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