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Reference

Laryngoscope glossary: terms in specifications and tenders

Short, plain definitions of the terms buyers meet in laryngoscope specifications and tenders, from blade, flange and hook-on fitting to UDI, SRN and MDMA.

Laryngoscope specifications and tenders mix engineering, clinical and regulatory language. This glossary gives short, plain definitions of the terms buyers meet most often, listed alphabetically within each theme. Clinical terms are simplified for procurement use and are not clinical guidance.

Instrument

Blade

The part inserted into the mouth to move the tongue aside and expose the larynx. Most designs fold down for storage and lock at about a right angle for use.

Conventional laryngoscope

A laryngoscope with its lamp in the blade near the tip, powered from the handle through electrical contacts. Its parts are not designed to work with green-system parts.

Flange

The side wall of the blade that keeps the tongue out of the line of sight. Reduced-flange designs leave more room when mouth opening is limited.

Green system

Fiber-optic laryngoscopes made to the fiber-optic fitting of ISO 7376: the light source is in the handle and the blade carries only a light guide. Parts usually carry a green marking.

Handle

The grip that holds the batteries and, in the green system, the lamp or LED. Common forms are standard, slim (penlight) and short (stubby).

Heel

The base of the blade, where it meets the handle. On a green-system blade, this is where light enters the light guide.

Hook-on fitting

The connection in which a slot in the blade’s base hooks onto a bar on the handle head, letting the blade swing up and click into the working position. ISO 7376 sets its critical dimensions.

MacFlex

A Macintosh-pattern blade with a hinged tip, raised by a lever near the handle to lift the epiglottis further. Similar designs are sold as lever-tip or flexible-tip blades.

Macintosh

The curved blade described by Sir Robert Macintosh in 1943. Its tip usually sits in the vallecula and lifts the epiglottis indirectly.

Miller

The straight blade described by Robert Miller in 1941, slightly curved near the tip. It usually lifts the epiglottis directly and is common in neonates and infants.

Spatula

The long part of the blade that rests on the tongue. In German the whole blade is usually called a Spatel, meaning spatula.

Tip

The far end of the blade, placed in the vallecula with curved blades or beneath the epiglottis with straight blades. Its edges should be smooth and rounded.

Light and power

Acrylic light guide

A light guide of solid clear plastic rather than glass fibers, carrying light by internal reflection. It is often used on single-use blades.

Fiber-optic bundle

A bundle of fine glass fibers carrying light from the handle to a window near the blade tip. Broken fibers show as dark spots on the end face.

LED

Light-emitting diode, a semiconductor light source offering long life, low heat and low battery drain. Its light colour depends on the LED chosen.

Xenon lamp

A small filament lamp filled with xenon gas, often with halogen, giving a warm white light. It wears out and is replaced when it fails.

Clinical terms

Epiglottis

A leaf-shaped flap of cartilage behind the base of the tongue that covers the larynx during swallowing. It must be lifted, directly or indirectly, to see the vocal cords.

Glottis

The vocal cords and the opening between them, which the clinician needs to see before passing a tube.

Intubation

Tracheal intubation: placing a tube in the trachea, usually through the mouth, to secure the airway and allow ventilation. The laryngoscope provides the view.

Reprocessing

Everything done to make a used reusable device ready for the next patient, from cleaning to disinfection or sterilisation, packaging and storage, as validated in the IFU.

Semi-critical

In the Spaulding classification, an item that contacts mucous membranes or non-intact skin and needs at least high-level disinfection. Laryngoscope blades usually fall here; guidance for handles varies.

Vallecula

The hollow between the base of the tongue and the epiglottis, where the tip of a curved blade is usually placed. Strictly there are two, one each side of a midline fold.

Regulation and quality

CE marking

The manufacturer’s mark showing conformity with EU requirements. Where a notified body took part, its four-digit number follows the mark.

EUDAMED

The European database on medical devices, holding registrations of economic operators, device and UDI data, notified-body certificates and other regulatory information, part of it public.

FDA establishment registration

Annual registration with the US Food and Drug Administration of a site making devices for the US market, with a listing of those devices. It brings no certificate and is not FDA approval.

IFU

Instructions for use: the manufacturer’s document on intended use, warnings, operation and, for reusable devices, validated reprocessing.

ISO 7376

The international standard for laryngoscopes for tracheal intubation, covering hook-on fitting dimensions, a minimum light output and test methods.

ISO 13485

The international standard for quality management systems for medical devices. Certificates come from certification bodies, which buyers usually expect to be accredited.

MDMA

Medical device marketing authorisation, granted by the Saudi Food and Drug Authority (SFDA) before a device can be placed on the Saudi market.

MDR

The EU Medical Device Regulation, (EU) 2017/745, applicable since 26 May 2021. It replaced the earlier directives, including the Medical Device Directive (MDD).

Notified body

An independent organisation designated under EU rules to assess the conformity of certain devices. Each has a four-digit number and is listed in the European Commission’s NANDO database.

SRN

Single Registration Number, issued to a manufacturer, authorised representative or importer once a national competent authority has verified its EUDAMED registration.

UDI

Unique device identification: a code on the label, in barcode and plain-text form, identifying the device model (UDI-DI) and production data such as lot or serial number (UDI-PI). The EU also uses a Basic UDI-DI to link a device group to its records.

Buying

ECO line

A name some makers use for an economy range. Its meaning differs between makers, so compare specifications such as material, light guide, finish and reprocessing limits, not names.

OEM

Original equipment manufacturer. In this trade, OEM production usually means a maker produces devices that another company sells, often to that company’s specification.

Private label

Devices made by one company and sold under another’s brand. Agree early who is named as legal manufacturer on the label; under EU rules, that party carries the manufacturer’s obligations.

Reusable

Designed to be reprocessed and used on many patients, within the methods and limits given in the IFU.

Single-use

Intended for one patient during a single procedure, then discarded. It must never be reprocessed; the label carries the “do not re-use” symbol, a crossed-out 2.

If a term in your tender documents is not listed here, ask our export team.

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