Wondfo Optical Coagulation Analyzer

Trade name

Wondfo Optical Coagulation Analyzer

06933289811149

69332898CE1114EP

Reference / catalog number

W958

GS1

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Optical Coagulation Analyzer is an in vitro diagnostic device used for the quantitative determination of concentration of various coagulation factors in human whole blood. The specific sample type is subject to the instructions for use of coagulation test card that used along with and manufactured by Guangzhou Wondfo Biotech Co., Ltd. The Optical Coagulation Analyzer is for in vitro diagnostic use only. It is intended to be used by healthcare professionals in laboratories as well as Near-Patient Testing (NPT). It is not intend- ed for self-testing.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0202020101SEMI-AUTOMATED COAGULOMETERS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  − Do not dismantle the instrument. − Do not use test strips which are NOT provided by Guangzhou Wondfo Biotech Co., Ltd. − Do not use test strips, which are beyond the expiration date or have been improperly stored. − Do not use excessive force in inserting test strips or ID chip. − Do not drop the instrument. − Do not spill any liquid on the instrument. − Do not use the instrument near a strong electro- or magnetic field, such as mobile phone, microwave oven, as this may interfere with the instrument’s proper operation. − Please balance the analyzer, test strip and sample at room temperature before use. − The instrument should be operated on a horizontal and vibration-free surface. Don’t hold the instrument in hands during testing. − Don’t move or touch the analyzer or test strip during testing. − The test strip is for single use only. Don’t reuse the test strip or add additional sample to a test strip. These operations may lead to wrong results. − Do not switch the power mode during testing (adaptor supply, battery supply). − Testing at low battery level may lead to inaccurate or wrong results. If the battery is running low, stop testing and connect to power supply. − When performing blood sample testing and other related operations, the operator should abide by the safety operation regulations and take safety protection measures (such as wearing protective clothing and gloves, etc.). − The analyzer should not be close to the wall, and there should be a distance of at least 20cm to ensure the ventilation of the analyzer and the space required by the operator for safe and effective maintenance. − There are test samples left on the used test card, which is a potential biological hazard. It should be recycled as medical waste or disposed of in accordance with the regulations of the local administrative department.