Icare HOME, Инструкция по эксплуатации

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21
Icare HOME
17. LIFETIME
The expected service life of the device is 5 years. The maintenance described in the
chapters 10-12 is required during the the expected service life. The shelf life of the
probes in their intact original packaging is 3 years.
We also recommend that you inspect the device for mechanical and functional
damage and the safety labels for legibility annually/every 12 months.
18. TECHNICAL AND PERFORMANCE 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, for example Energizer Lithium Photo 123 3V CR123A).
Measurement range: 5-50 mmHg.
Accuracy and precision (bench study): Icare performed testing to evaluate the
accuracy and precision of the Home tonometer in its intended measuring range in
accordance with ANSI Z80.10 “Ophthalmic Instruments – Tonometers”. The testing
was performed by measuring a manometrically controlled test eye. The pressure in
the test eye was adjusted by a hydrostatic head and controlled manometrically by
an attached calibrated pressure sensor as reference. The measurements were
taken using the Icare HOME and additionally verified by a reference tonometer.
Differences between Icare HOME and actual pressure in model eyes were observed
to be within 1 mmHg in the pressure range 10-30 mmHg. At the extremes of the
measuring range, the differences were observed to be 2 mmHg at the 5 mmHg level
and 2-3 mmHg at the 40 and 50 mmHg levels. Similarly, the precision of the device
was observed to be better within the pressure range 10-50 mmHg (i.e. CV of 0.0% -
5.5%) as compared to the 5 mmHg pressure level (i.e. CV of 8.1%).
Icare HOME tonometer Instruction manual for health care professionals
16. ACCESSORIES
English
Part number Product Description Weight Dimensions
540 Probe base 4 g 7 mm x 38 mm
TA022-001 Probe base collar 2g 20 mm x 15 mm
560 Wrist strap 3g 270 mm x 10 mm x 10 mm
TA022-044 Carrying case 210 g 270 mm x 135 mm x 60 mm
7179 Battery cover 3g 26 mm x 23 mm x 7 mm
TA022-035 Patient guide 33g 210 mm x 90 mm x 2 mm
571 Battery 3 V, CR123A 17 g 17 mm x 35 mm
TA022-037 Support position tags 40g 70 mm x 41 mm x 13 mm
575 USB cable 23g 1m
113 Box of 50 probes 55,14g 8,2 x 19,5 x 3,5 cm
Icare HOME tonometer Instruction manual for health care professionals ENGLISH 21 www.icare-usa.com