Clinical Performance Data; Symbols - Icare PRO TA03-026-1.0 Manual De Instrucciones

• Accuracy: ± 1.2 mmHg (≤20 mmHg) and ±
2.2 mmHg (>20 mmHg)
• Repeatability (coefficient 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 effect of
close to one on the Icare PRO tonometer value;
the coefficient of determination is R2 = 0.890.
55°C
-10°C
10%
70°C
-40°C
10%
Temperature Humidity
limits limits
95%
1060hPa
700hPa
95%
1060hPa
500hPa
Atmospheric
pressure limits
The mean of the paired difference (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
Serial number
SN
Use by <date>
Keep dry
Manufacturing date
Lot number
LOT
Sterilized using irradiation
Stand by
Do not dispose of in household waste.
Manufacturer
Warning
Storage
environment
Transport
environment
English
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