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Icare HOME tonometer Instruction manual for health care professionals
Icare HOME
4
WARNING!
Federal (US) law restricts this device to sale by or on the order of a physician or properly
licensed practitioner.
WARNING!
Use only the original and certified probes made by the manufacturer. The probes are for
single-use (one per testing session only). Each testing session is defined by one successful
measurement in both eyes (or only one eye measurement if indicated). 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!
The probe should be replaced if it contacts or is suspected of having contacted the
eyelashes or eyelid such as might occur during a blink.
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.
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.
PRECAUTION!
•
The patient should be instructed to thoroughly wash and dry their hands with soap
and a clean towel prior to handling the probe.
•
When you have opened the package, check for any external damage or faults,
particularly for damage to the case. If you suspect that there is something wrong
with the tonometer, contact the dealer who sold the tonometer to you.
•
Use the tonometer only for measuring intraocular pressure. Any other use is
improper and the manufacturer is not liable for any damage arising from improper
use, or for the consequences of such use.
•
Never open the casing of the tonometer, except for the battery compartment.
•
Never allow the tonometer to get wet.
•
Do not use the tonometer near flammable substances, including flammable
anesthetic agents.
•
Certain microbiological agents (for example, bacteria) can be transmitted from the
forehead or cheek support. To prevent this, clean the forehead and cheek support
for each new patient with disinfectant. See the chapter ‘Cleaning and disinfection’.
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Icare HOME
PRECAUTION!
•
The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference
may occur within the tonometer if used near (<1m) a device causing high intensity
electromagnetic emissions, such as a cellular phone. 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, for example sensitive sensors.
•
If you do not use the tonometer for a long time, remove the batteries, as they may leak.
•
Be sure to dispose of the single-use probes properly (for example, in a bin for metal waste).
•
Batteries, packaging materials and probe bases must be disposed of according to local
regulations.
•
Make sure you use batteries with built-in PTC protection, for example Energizer Lithium
Photo
123 3V CR123A.
•
Do not cover the eye recognition transmitters or sensor during the measurement, for
example
with fingers. Keep your hand, hair etc. and objects such as pillows away from the
temple side of
your eye, as they produce an infrared reflection that causes an error.
•
The tonometer turns off automatically after 3 minutes if it is not used.
•
Do not carry out any other service procedures than those described in the chapters 10-12. Leave
all other service and repairs to the manufacturer or a certified service center.
•
Update the tonometer’s time to your local time. It is done automatically by performing the
steps
1 and 2 under section 8. Reading the measurement data.
•
Icare HOME tonometer is not intended for routine clinical use.
•
As the Icare HOME is intended to acquire serial measurements of intraocular pressure over
an
extended period of time, individual IOP measurements are not to be considered
separate from
their associated IOP curves. This IOP measurement tool is an adjunct to the
standard of care
and does not replace the conventional methods used to diagnose and
manage patients nor
should it alter the follow-up schedule otherwise indicated for a
particular patient.
•
Bench testing of the Icare HOME tonometer on model eyes showed that there was no impact on
probe function and performance with 30 repeated uses within a single testing session. The
impact on probe function and performance when the probe is repeatedly used over 30 times is
unknown.
English
Icare HOME tonometer Instruction manual for health care professionals
Icare HOME tonometer Instruction manual for health care professionals
ENGLISH
4
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