Icare HOME Patient Guide
ENGLISH
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www.icaretonometer.com
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CLINICAL PERFORMANCE DATA
•
No complications (including corneal abrasions)
were recorded.
•
The eye pressure ranges measured were ≤16
mmHg, >16 to <23 mmHg and ≥23 mmHg (mmHg
is the unit of measure for eye pressure).
•
The average difference of Icare HOME versus
the gold standard measurement method
(Goldmann measurement device that is used in
eye clinics) was approximately 0.5 mmHg (the
average pressure measurement in the study was
approximately 18 mmHg with a range of 5 to 50
mmHg).
• Compared to the Goldmann tonometer, less than
5% of measurements fell outside ± 5 mmHg at
each pressure range and less than 1% fell outside
± 7.5 mmHg at each pressure range.
•
The Icare HOME’s variability (difference of repeat
measurements) on the same eye was ~10% for
the low and medium pressure range and ~7.5%
for the high pressure range.
•
Only certified users were able to proceed to
self-testing. 10.7% of the patients failed to pass
training/certification.
•
In this study, self-testing was limited to a single
session 10 minutes after certification.
A study was conducted with 383 patients
performing self-measurements with the
Icare HOME tonometer. A summary of the
study findings are below:
LIFETIME
The expected service life of the device is 5 years.
Following the instructions described in this
manual is required during the the expected service
life. The shelf life of the probes in their intact
original packaging is 3 years. Please check the
shelf life (expiration date) from the probe label.
We recommend that you inspect the device for
mechanical and functional damage and the safety
labels for legibility annually/every 12 months.
The life time of the batteries is about 5000
measurements.
TECHNICAL DATA
Type:
TA022
Dimensions:
approximately 11cm x 8cm x 3cm
Weight:
approximately 150g
Power supply:
2 x CR123 non-rechargeable batteries
(make sure you use batteries with built-in PTC
protection, Energizer, Varta, Panasonic or Toshiba
Lithium 3V CR123A)
Measurement range:
5-50 mmHg
Accuracy
(95% tolerance interval relatively to
manometry): ±1,2mmHg (≤20 mmHg) and ±2.2
mmHg (>20 mmHg)
Repeatability
(coefficient of variation): < 8%
The serial number is located on the inside of the
battery compartment cover. The lot number of the
probes is on the side of the probe box and the blister
packing. There are no electrical connections from
the tonometer to the patient. All the parts of the
tonometer are applied parts and the tonometer has
BF-type electric shock protection.
