Indications For Use; Brief Description Of The Instrument; Intended Use / Purpose Of Instrument; Safety - Keeler Pulsair IntelliPuff Gebrauchsanleitung

Verfügbare Sprachen

INDICATIONS FOR USE

These devices are intended to be used only by suitably trained and authorised healthcare

professionals.

The Pulsair IntelliPuff Non-Contact Tonometer should be used only by

trained personnel. USA Federal law restricts this device to sale by or order

of a physician.

1.1

It is an 'air puff' Tonometer designed to accurately measure Intra Ocular Pressure (IOP) without

making contact with the surface of the eye.

This device is intended to be used by a trained healthcare professional only in a healthcare

environment. Air impulse tonometry is a variant of the general applanation tonometry in which

a portion of the cornea is flexed by mechanical stimuli in which the force / pressure required to

produce the flexing effect is related to the intraocular pressure.

The air puff technique requires directing a calibrated quantized packet of air towards the

central portion of the cornea, and the detection of the pre-defined deformation of the cornea

through optical means and reflections from the corneal surface.

The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure

without contacting the eye to aid in the screening and diagnosis of glaucoma.

CAUTION: The light emitted from this instrument is potentially hazardous.

The longer the duration of exposure, the greater the risk of ocular

damage.

While no acute optical radiation hazards have been identified for Keeler

Tonometers, we recommend keeping the intensity of the light reaching

the patient's retina to the minimum possible for the respective diagnosis.

Children, people with aphakia and people suffering from eye conditions

are most at risk. An increased risk may also occur if the retina is exposed

to the same or a similar device with a visible light source within 24 hours.

This applies, in particular, if the retina has been photographed with a

flashbulb in advance.

Keeler Ltd shall on request, provide the user with a graph showing the

relative spectral output of the instrument.

Pulsair Intellipuff Tonometer by KEELER

Inhaltsverzeichnis