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TECHNICAL INFORMATION
The serial number is on the inside of the battery compartment cover. There are no electrical connections from the tonometer to the patient. The device has
BF-type electric shock protection. The single use probe and the forehead support of the device are considered as applied parts.
IT-NETWORK SPECIFICATIONS
WARNING
Connection of the ic200 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 ic200 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 ic200 tonometer to a host device, the tonometer must be connected to responsible organizations IT Network over
Bluetooth. The ic200 tonometer is designed to work stand-alone without the Bluetooth connection. The ic200 tonometer is designed such that network failures
will not prevent the ic200 tonometer from working normally.
Required characteristics of the IT-network:
Printer: Bluetooth® Classic, ESC/POS communication protocol.
Computer: Bluetooth® 4.0 (or greater) Low Energy support.
Connection is secured by link authentication.
Intended Information Flow:
Measurement data is collected by the ic200 Tonometer. This data is sent via Bluetooth connection either to a wireless printer (Bluetooth Classic), or to the
computer (Bluetooth Low Energy, BLE) which has the Icare Export application installed. The Icare Export will transfer the data into the Icare CLINIC software.
Operators can then access the data by using the Icare CLINIC software with a web browser in an internet connected device.
Potential Hazardous situations resulting from the failure of the IT-network:
• If the Bluetooth connection is lost during data transfer, no data is lost from the device. The measurement data can still be found from the device history and
transferred once the connection is re-established.
• Failure or misconfiguration of the IT-network may result in data not being transferred causing inconvenience to the operators.
ACCESSORIES
SKU PRODUCT DESCRIPTION WEIGHT DIMENSIONS
104 Probe Icare TP01, 100 pcs/box 89 g 53 x 109 x 36 mm
540 Probe base 4 g 7 x 38 mm
559 Wrist strap with lock 4 g 10 x 10 x 270 mm
527 Aluminum case, Icare ic200 800 g 240 x 280 x 72 mm
7169 Battery cover & screw 6 g 110 x 25 x 12 mm
619 IOP pad, Icare ic200 38 g 50 x 53 x 16 mm
565 Silicone grip white 26 g 45 x 35 x 113 mm
566 Silicone grip green 26 g 45 x 35 x 113 mm
567 Silicone grip dark gray 26 g 45 x 35 x 113 mm
568 Silicone grip blue 26 g 45 x 35 x 113 mm
568A Silicone grip pink 26 g 45 x 35 x 113 mm
548 Screwdriver 15 g 16 x 90 mm
577E USB memory stick, Icare ic200 44 g 98 x 11 x 93 mm
544B Probe base cover, Icare ic200 1 g 19 x 11 mm
Type: TA031
Dimensions: 43 mm (W) x 104 mm (H) x 214 mm (L).
Weight: 165 g (without batteries)
Power supply: 4 x AA non-rechargeable batteries, 1.5 V alkaline LR6.
Measurement range: 7-50 mmHg
Accuracy: ±1.2 mm Hg (≤20 mmHg) and ±2.2 mm Hg (>20 mmHg).
Repeatability (coefficient of variation): < 8 %.
Accuracy of display: 0.1 mmHg.
Display unit: Millimeters of mercury (mmHg).
Mode of operation: continuous.
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa to 1,060 hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500 hPa-1,060 hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa to 1,060 hPa
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