Keeler Pulsair IntelliPuff, Instructions For Use Manual, Page: 7 / 110

3 EN
Pulsair Intellipuff Tonometer by KEELER
1. 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 BRIEF DESCRIPTION OF THE INSTRUMENT
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.
1.2 INTENDED USE / PURPOSE OF INSTRUMENT
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.
2. SAFETY
2.1 PHOTOTOXICITY
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.