Icare tonometer ONE manual
English
2
www.icaretonometer.com
Icare® ONE (Model: TA02) INSTRUCTION MANUAL v1.12
01/14 EN
0044
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2012 Icare Finland Oy
Made in Finland
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icarefinland.com, [email protected]
TABLE OF CONTESTS
Table of contests ................................................................................................................................................................................................................2
Safety instructions .............................................................................................................................................................................................................2
Indications for use .............................................................................................................................................................................................................3
Usage contraindications ....................................................................................................................................................................................................4
Introduction .......................................................................................................................................................................................................................4
Package contents ...............................................................................................................................................................................................................4
Turning the device on ........................................................................................................................................................................................................5
Setting up the tonometer before taking measurements ...................................................................................................................................................6
Choosing a measurement mode ........................................................................................................................................................................................6
Adjusting the measurement position.................................................................................................................................................................................6
Loading the probe ..............................................................................................................................................................................................................7
Measuring intraocular pressure .........................................................................................................................................................................................8
Patient Use Instructions .....................................................................................................................................................................................................9
Error messages and indicators .........................................................................................................................................................................................10
Differences between professional user and the patient using the Icare ONE Tonometer ...............................................................................................10
Cleaning and disinfection .................................................................................................................................................................................................11
Changing the batteries .....................................................................................................................................................................................................11
Service procedures ..........................................................................................................................................................................................................12
Spare parts .......................................................................................................................................................................................................................12
Technical and performance data .....................................................................................................................................................................................12
Clinical performance data ................................................................................................................................................................................................13
Symbols ...........................................................................................................................................................................................................................14
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 5/32-5/16
inch, from the eye).
WARNING!
The device probe tips have not been evaluated for the presence of endotoxins. The probe tips are for single-use only, and are packaged sterile.
WARNING!
The Icare ONE Tonometer (TA02) is intended to be used only under supervision and control of the health care professional only.