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Icare HOME
Icare HOME tonometer Instruction manual for health care professionals
English
Safety:
No adverse events (including corneal abrasions) were recorded in this study
population of 383 eyes.
Anterior corneal epithelial grading was performed at baseline and after each attempt to
measure IOP using the Oxford Scheme (a scale from 0-5) illustrated in the study protocol. It
should be noted that these findings represent a “worst case scenario” as during the study
visit subjects underwent more HOME measurements in a short period of time compared to
what would be experienced by patients in real world use of the device. Nonetheless, under
these study conditions, only 5% of eyes experienced an increase in staining after
certification compared to baseline and only one eye (0.3%) experienced an increase of two
grades or more which is generally considered a clinically significant change due to
variability in the slit lamp grading scales. After the series of three HOME measurements
(bringing the total of HOME measurements to four plus the one GAT certification
measurement), the number of eyes experiencing an increase in staining increased to 11.3%;
however, only five (1.3%) eyes experienced a clinically significant increase in staining.
Furthermore, it should be noted that GAT induced an increase of two grades or more in two
study eyes which is not unexpected. After all HOME measurements had been taken, no
subject experienced an increase of three grades or more in staining compared to baseline.
Before certification, after certification, and after the series of HOME validation
measurements, subjects were asked to rate eye discomfort by placing a vertical mark on
the VAS horizontal line to indicate the level of eye discomfort. 0% corresponds to “no
discomfort” and 100% corresponds to “maximal discomfort”. There was essentially no
change in discomfort following the certification procedures (which consisted of three HOME
measurements and one GAT measurement) and the series of three HOME validation
measurements. The median change from baseline was zero and the maximum increase
was only 23 units on the 100 point VAS scale.
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Icare HOME
Keep dry
Manufacturing date
Lot number
SN
STERILE R
LOT
Storage environment
Transport environment
Temperature limits
Humidity limits
Atmospheric pressure limits
-10°C
55°C
95%
10%
1060hPa
700hPa
-40°C
70°C
95%
10%
1060hPa
500hPa
Class 1
LED product
English
Icare HOME tonometer Instruction manual for health care professionals
19.
SYMBOLS
Caution
See operating
instructions for more
information
BF-type device
Single-use disposable
Serial number
Use by <date>
Manufacturer
Federal law (U.S.)
restricts this device to
sale by or on the order
of a physician.
Rx Only
IP22
Sterilized using irradiation
Stand by
Do not discard this product with
other household-type waste. Send to
appropriate facility for recovery and
recycling. EU WEEE (European Union
Directive for Waste of Electronic and
Electrical Equipment)
Protected against insertion of
fingers and will not be damaged or
become unsafe during a specified
test in which it is exposed to
vertically or nearly vertically
dripping water.
This product meets the power requirements for a Class 1 LED
product to IEC/EN 60825-1 (2001) under normal operating conditions
and those of single fault failure.
Icare HOME tonometer Instruction manual for health care professionals
ENGLISH
28
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