Icare TA01i, Instruction Manual

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1
English
ENGLISH
TONOMETER
Icare® TA01i
INSTRUCTION MANUAL
The information in this document is subject to
change without prior notice.
In a conflict situation the English version
prevails.
0598
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
RoHS Directive 2011/65/EU
Copyright © 2017 Icare Finland Oy
Made in Finland
Icare Finland Oy/Tiolat Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icaretonometer.com,
info@icarefinland.com
INDICATIONS FOR USE
The Icare tonometer TA01i is intended to be
used for the measurement of intraocular
pressure of the human eye.
INTRODUCTION
The Icare tonometer is used in the diagnosis,
follow up and screening of glaucoma. It is based
on a new, patented, induction-based rebound
method, which allows intraocular pressure (IOP)
to be measured accurately, rapidly and without
an anesthetic.
Since single-use probes are used
for measurement, there is no risk of
microbiological contamination. No part of the
tonometer or probes are made with natural
rubber latex. Intraocular pressure changes
due to the effects of the pulse, breathing,
eye movements and body position. Because
measurements are taken using a handheld
device in fractions of a second, several
measurements are needed to obtain an
accurate reading and there fore the software is
pre-programmed for six measurements.
SAFETY INSTRUCTIONS
WARNING
The tonometer must not come into contact with
the patient’s eyes, except for the probes, which
may do so for a fraction of a second during
measurement. Do not bring the tonometer into
contact with the eye or push it into the eye (the
tip of the probe should be 4-8mm, or 5/32 -
5/16inch, from the eye).
WARNING
The tonometer should only be opened by
qualified service personnel. It contains no
userserviceable parts, apart from the batteries
and a probe base. The Icare tonometerrequires
no routine servicing or calibration other than
changing the batteries at least every 12 months
or changing or cleaning the probe base. If
servicing is necessary, contact qualified service
personnel or your local Icare representative.
WARNING
Never spray, pour or spill liquid onto the Icare
tonometer, its accessories, connectors, switches
or openings in the chassis. Dry any liquid on the
surface of the tonometer immediately.
WARNING
Use of this equipment adjacent to or stacked with
other equipment should be avoided because
it could result in improper operation. If such
use is necessary, this equipment and the other
equipment should be observed to verify that they
are operating normally.
WARNING
Use of accessories other than those
specified or provided by the manufacturer
of this equipment could result in increased
electromagnetic emissions or decreased
electromagnetic immunity of this equipment
and result in improper operation.
CAUTION
Read this manual carefully, since it contains
important information on using and servicing
the tonometer.
• Retain this manual for future use.
• When you have opened the package, check