Icare Pro TA03 - Indications for Use

2
Icare tonometer PRO manual
• Use the tonometer only for measuring
intraocular pressure. Any other use is
improper and the manufacturer is not
responsible for any damage arising from
improper use, or for the consequences
thereof.
• Never open the casing of the tonometer
except in order to change the probe base.
• Do not use the device near inammable
substances, including inammable
anesthetics.
• Certain microbiological agents (for example,
bacteria) can be transmitted from the
forehead support. To avoid this, clean the
forehead support for each new patient with
disinfectant; see the chapter ‘Cleaning the
tonometer’.
• The tonometer conforms with EMC
requirements (IEC 60601-1-2), but
interference may occur if it is used near
(<1m) a device (such as a cellular phone)
which gives o high-intensity electromagnetic
emissions. Although the tonometer’s own
electromagnetic emissions are well below the
levels permitted by the relevant standards,
they may cause interference in other, nearby
devices, such as sensitive sensors.
• Be sure to dispose of the single-use probes
properly (for example, in a container for
disposable needles), because they may
contain microorganisms transferred from the
patient.
• Dispose of the device, components and
accessories in accordance with the applicable
local regulations.
• If you do not use the tonometer when it is
switched on, it will turn o automatically after
3 minutes.
• No anesthetic is required when performing
measurements.
2. INDICATIONS FOR USE
WARNING
The safety and eectiveness of the Icare PRO
tonometer has not been evaluated for
patients with:
• Only one functional eye.
• Poor or eccentric xation in one eye.
• High corneal astigmatism (i.e. in the case
of eyes for which an oval contact image
is displayed when examined using the
Goldmann tonometer).
• Corneal scarring.
• A history of incisional glaucoma surgery
or corneal surgery, including corneal laser
surgery.
• Microphthalmos.
• Buphthalmos.
• Contact lenses.
• Dry eyes.
• Squeezed lids (blepharospasm).
• Nystagmus.
• Keratoconus.
• Any other corneal or conjunctival pathology
or infection.
• A central corneal thickness greater than
0.600mm or less than 0.500 mm
The Icare PRO tonometer is a prescription-
based device intended for measuring
intraocular pressure (IOP) in the human eye. It
is indicated for use by health care professionals.
3. INTRODUCTION
The Icare PRO tonometer is a hand-held device.
It uses a small and light single-use probe
that makes contact with the eye very briey,
removing the need for a topical anesthetic.
The Icare PRO tonometer allows you to
measure supine patients and patients in a
normal upright (sitting/standing) position.
The tonometer uses the rebound method.
Asmall and light single-use probe makes
contact with the eye very briey. The tonometer
measures the deceleration of the probe and
the rebound time, and calculates the IOP from
these parameters.
A measurement sequence includes six
measurements. The probe moves onto the
cornea and back during each measurement. As
a result, after six measurements the tonometer
calculates the nal IOP and stores it with
other information, such as the date, time, eye
identication (right or left) and measurement
quality, in the tonometer’s memory.
The Icare PRO tonometer records and displays
over one thousand measurement results, their
times and dates as well as quality information
associated with the measurement. You can copy
the recorded measurement information onto a
PC via a USB cable.