Network Specifications; Intended Information Flow; Potential Hazardous Situations Resulting From The Failure Of The It Network; Required Characteristics Of The It Network - Icare HOME2 Instruction Manual

• Android smart phone or tablet with USB OTG support, operating system
v6.0 or newer or iPhone with operating system iOS 12 or newer
• USB OTG C male – C male cable, supplied with the tonometer
• Internet connection
To verify the required USB OTG support in the smart phone or tablet, use the
OTG? application available on Google Play or another application providing
similar functionality.
17.3 IT network specifications
WARNING! Connection of the tonometer to IT networks including other equipment could
result in previously unidentified risks to patients, operators, or third parties.
WARNING! The responsible organization should identify, analyze, evaluate, and control
any additional risks resulting from the tonometer connected to IT networks including
other equipment.
PRECAUTION! Changes to the IT network could introduce new risks requiring additional
analysis by the responsible organization. The changes include:
• changes in the IT network configuration
• connection of additional items to the IT network
• disconnecting items from the IT network
• update or upgrade of equipment connected to the IT network
To transfer the measurement data from the tonometer to a mobile device
or a computer, the tonometer must be connected via Bluetooth or USB.
The mobile device or computer must be connected to the internet or the
hospital's IT network. The tonometer can be used as a stand-alone without a
Bluetooth or USB connection. The tonometer is designed in such a way that
network failures do not prevent the tonometer from working normally.
17.4

Intended information flow

The iCare HOME2 tonometer collects measurement data. This data is sent
via Bluetooth or USB connection to a computer (Bluetooth Low Energy, BLE)
which has the iCare EXPORT software installed or to a mobile device with
the iCare PATIENT2 application installed.
iCare EXPORT or iCare PATIENT2 transfers the data into the iCare CLINIC
software. You can access the data online using the iCare CLINIC software
with a web browser.
17.5 Potential hazardous situations resulting from the
failure of the IT network
If the IT network connection is lost during the data transfer, no data is lost
from the tonometer. The measurement data can still be found from the
tonometer memory and transferred once the connection is re-established.
Failure or misconfiguration of the IT network may result in data not being
transferred.
17.6

Required characteristics of the IT network

The responsible organization is strongly recommended to maintain
virus protection up to date on the computers and mobile devices used.
The responsible organization is also recommended to install security updates
to the used web browsers, computers, and mobile devices when available.
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17.7

Performance data

17.7.1 Pre-clinical testing
The iCare HOME2 tonometer is an incremental design to the predicate
tonometer iCare HOME. It features the same underlying rebound technology
with enhanced usability and user interface.
The performance data was obtained from a clinical study performed
according to ANSI Z80.10-2009 and ISO 8612 with the predicate tonometer
iCare HOME. In this extensive (N=376) multi-center clinical trial, iCare HOME
was found to fulfil the performance goals set in ANSI Z80.10-2009.
Results: The mean difference and standard deviation (iCare HOME - GAT)
were -0.53 mmHg and 2.43 mmHg, respectively. All ANSI performance goals
were met as 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.
Safety: No adverse events (including corneal abrasions) were recorded in
this study population.
Group N HOME Reference Difference
Mean (SD) Mean (SD) Mean (SD)
Reference: GAT (Mean/Median Measurement)
≤16 mmHg 143 12.44 12.86
(3.18) (2.17)
>16 to <23 167 18.26 18.99
mmHg (2.91) (1.78)
≥23 mmHg 66 26.18 26.41
(5.52) (4.86)
Overall 376 17.44 17.96
(6.01) (5.50)
Accuracy and repeatability of the iCare HOME2 tonometer was assessed in
a bench test. The test was done by measuring a manometrically controlled
artificial cornea. The test pressures (7, 10, 20, 30, 40, and 50 mmHg) covered
the specified measurement range of the iCare HOME2 tonometer. To assess
the accuracy and repeatability, 20 measurements were performed with three
iCare HOME2 tonometers at three different measurement angles (the probe
pointing at the artificial cornea at 0, 45, and 90 degrees to the horizontal).
Same measurements were repeated with three different iCare IC200
tonometers. This resulted in 180 measurements with each tonometer type
at each pressure level.
Results: The iCare HOME2 tonometer demonstrated a high agreement with
the manometric pressure as with the reference tonometer IC200, regardless
of the pressure level or the measurement angle. The maximum difference
with respect to the manometric pressure was observed at a 30 mmHg
pressure level (+1.3 mmHg) and the maximum difference with respect to
the reference tonometer IC200 was observed at a 7 mmHg pressure level
(+0.21 mmHg).
The iCare HOME2 tonometer fulfilled the accuracy and repeatability
specification ±1.2mmHg (≤ 20 mmHg) and ±2.2 mmHg (> 20 mmHg) with
coefficient of variation less than 8%.
95% CI 95% LOA Outside
for Mean for Mean ± 5 mmHg
Difference Difference
n (%)
-0.84 -0.84, -5.50, 4.65 4 (2.8%)
(2.54) -0.00
-0.73 -1.09, -5.45, 3.99 7 (4.2%)
(2.36) -0.37
-0.23 -0.81, -5.00, 4.55 1 (1.5%)
(2.39) -0.36
-0.53 -0.77, -5.39, 4.34 12 (3.2%)
(2.43) -0.28
Outside
± 7.5 mmHg
n (%)
1 (0.7%)
0 (0.0%)
0 (0.0%)
1 (0.3%)
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