Icare Pro TA03 - Clinical Performance Data; Symbols

9
English
• Accuracy: ± 1.2 mmHg (≤20 mmHg) and ±
2.2mmHg (>20 mmHg)
• Repeatability (coecient of variation): <8%
• Accuracy of display: 0.1 mmHg
• Display unit: mmHg
• The serial number can be shown on the
screen (Settings/About)
• There are no electrical connections between
the tonometer and the patient
• The device has BF-type electric shock
protection
• Charger input 100-240 V ~50/60 Hz 300mA,
Output 5.0 V=1,200 mA
• Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa-
1,060hPa
• Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa-
1,060hPa
• Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500hPa-
1,060hPa
• Mode of operation: continuous
17. CLINICAL PERFORMANCE DATA
Performance data was obtained from a clinical
study, performed in accordance with the ISO
8612 standard for tonometers. It was estimated
that the reference tonometer had an eect of
close to one on the Icare PRO tonometer value;
the coecient of determination is R2 = 0.890.
The mean of the paired dierence (Goldmann-
Icare PRO tonometer) was 0.0 (≤16mmHg
0.4; >16<23 -0.4; ≥23 -0.3) and the standard
deviation was 2.7 (Figure14 and 15).
18. SYMBOLS
See operating instructions for more
information.
BF-type device
Single-use disposable
SN
Serial number
Use by <date>
Keep dry
Manufacturing date
LOT
Lot number
Sterilized using irradiation
Stand by
Do not dispose of in household waste.
Manufacturer
Warning
-10°C
55°C
95%
10%
1060hPa
700hPa
-40°C
70°C
95%
10%
1060hPa
500hPa
Storage
environment
Transport
environment
Temperature
limits
Humidity
limits
Atmospheric
pressure limits