10. Specifications
EN54
•This device is clinically investigated according to the requirements
of ISO 81060-2:2013 (excluding pregnant and pre-eclampsia
patients). In the clinical validation study, K5 was used on 85
subjects for determination of diastolic blood pressure.
•This device has been validated for use on pregnant and
pre-eclampsia patients according to the Modified European Society
of Hypertension Protocol*
•This device has been validated for use on diabetic (Type II)
population**
* Topouchian J et al. Vascular Health and Risk Management
2018:14 189–197
** Chahine M.N. et al. Medical Devices: Evidence and Research
2018:11 11–20
*** SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
About a wireless communication interference
This product operates in an unlicensed ISM band at 2.4 GHz. In the
event this product is used near other wireless devices such as
microwave and wireless LAN, which operate on the same frequency
band as this product, there is a possibility that interference may
occur.
If interference occurs, stop the operation of the other devices or
relocate this product away from other wireless devices before
attempting to use it.
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