Safety Instructions - icare HOME TA022-088-1.0 Manual De Instrucciones

ENGLISH
Icare HOME (Model: TA022) INSTRUCTION MANUAL
®
The information in this document is subject to change without prior notice.
In a conflict situation the English version prevails.
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
Äyritie 22, 01510 Vantaa
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icaretonometer.com, [email protected]
1.

SAFETY INSTRUCTIONS

WARNING!
Do not push the tonometer into the eye (the tip of the probe should be 4-8mm, or
5/32-5/16", from the eye).
WARNING!
Keep the tonometer out of the reach of children, because the probe base, battery
compartment cover and probes are so small that a child could swallow them.
WARNING!
The probe tips are for single-use only, and are packaged sterile.
WARNING!
To prevent contamination, do not touch the bare probe, do not use a probe if it
touches a non-sterile surface like a table or a floor.
WARNING!
Health care professionals must inform patients not to modify or discontinue their
treatment plan without receiving instructions from the health care professional.
WARNING!
For cybersecurity do not connect to the USB port except when uploading
patient measurement data. Also the tonometer does not allow you to take any
measurements when the USB is connected. All other traditional cybersecurity
controls (anti-virus software, malware software, separate network for the device,
etc.) do not apply since the device is stand alone, is not networked, and does not
contain operating system software.
WARNING!
Do not change the batteries or probe base when the USB cable is connected.
WARNING!
No modification of this equipment is allowed.
WARNING!
Use only the original and certified probes made by the manufacturer. The probes
are for single-use (single pair of measurement sequences) only. Use probes taken
only from the intact, original packaging. The manufacturer cannot guarantee
sterility of the probe once the seal is compromised. Re-sterilization or re-use
of the probe could result in incorrect measurement values, in the breakdown
of the probe, cross-contamination of bacteria or viruses, and infection of the
eye. Re-sterilization or re-use will void all responsibilities and liabilities of the
manufacturer concerning the safety and effectiveness of the tonometer.
WARNING!
Use of accessories, transducers and cables 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.
English
0598
1