Safety Instructions - icare HOME TA022-088-3.1 Manual De Instrucciones

www.icaretonometer.com
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 © 2020 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
4-8 mm, or 5/32-5/16", from the eye). Never use a probe that has no plastic tip.
WARNING!
Keep the tonometer out of the reach of children and pets, because the probe
base, battery compartment cover and probes are so small that a child could
swallow them.
WARNING!
The probes are for single-use only, and are packed 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.
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