Residual Risks
|
Electric leakage causes electrical shock. |
The product uses a battery power supply that will not cause electrical shock due to leakage. |
Acceptable |
|---|---|---|
|
Incorrect cuff pressure results in incorrect blood pressure values. |
The user manual states that if you have doubts about blood pressure, you should inform your doctor. |
Acceptable |
|
Unable to automatically relieve pressure, causing the user discomfort. |
The user manual states that if you feel uncomfortable, you should stop the measurement. |
Acceptable |
|
The product is damaged during the delivery process and fails. |
If the product is damaged due to shipping, please contact the distributor. |
Acceptable |
|
Causes adverse skin reactions. |
All materials that come in contact with human skin have passed the biocompatibility test. |
Acceptable |
|
Electromagnetic fields interfere with other product functions. |
The products have passed EMC EN 60601-1-2 and IEC 301489-1/-17 verification tests. |
Acceptable |
|
The product function is affected by the interference of environmental electromagnetic fields. |
The products have passed EMC EN 60601-1-2 and IEC 301489-1/-17 verification tests. |
Acceptable |
|
Generates an electromagnetic interference that affects other nearby products. |
The products have passed EMC EN 60601-1-2 and IEC 301489-1/-17 verification tests. |
Acceptable |
|
Excessive pressure causes bruising or redness. |
The product has an over-pressure protection mechanism. If you feel unwell during the measurement, please remove the cuff and stop using the device. |
Acceptable |
|
Unable to automatically release pressure, causing the user discomfort. |
The product has an over-pressure protection mechanism. If you feel unwell during the measurement, please remove the cuff and stop using the device. |
Acceptable |
|
Incorrect use that result in incorrect blood pressure measurement. |
The user manual explains the correct way to use the device. |
Acceptable |
|
The blood pressure value measured (on OLED) by the device displays an incorrect error value, resulting in false judgement. |
The product has passed the wireless interference test and meets the requirements of EN 300 328 regulations. |
Acceptable |
|
Causes unstable blood pressure. |
The user manual explains error messages and precautions. |
Acceptable |
|
May cause injury or incorrect blood pressure. |
The user manual explains error messages and precautions. |
Acceptable |