14. Specifications
EN58
Note
• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013/EN ISO 81060-2:2014 and complies with
ISO 81060-2:2013/EN ISO 81060-2:2014 and ISO 81060-2:2018+A1:2020/EN ISO 81060-2:2019+A1:2020. In the clinical validation study,
K5 was used on 85 subjects for determination of diastolic blood pressure.
• This monitor has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor is protected against solid
foreign objects of 12.5 mm diameter and greater such as a finger, and against vertically falling water drops which may cause issues during
a normal operation.
• Operation mode is classification in accordance with IEC 60601-1.
• The heart rate displayed during ECG acquisition is an average over the last 5 seconds.
• The heart rate displayed in review and on reports is the average heart rate over the entire ECG recording.
• The heart rate during recording an ECG has a range from 30 bpm to 300 bpm, and a resolution of 1 bpm.
• Cuff is made with latex-free materials.
Accuracy of Afib algorithm
98% sensitivity and 97% specificity
1
1. Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. Int J Cardiol. 2013;165(1):193-4
About a wireless communication interference
The Bluetooth option in the product is used to connect to dedicated apps on mobile devices to synchronize date/time data from mobile
device to the product, and to synchronize measurement data from the product to mobile device. Further handling of the data on the
mobile device is up to the user’s discretion. This product operates in an unlicensed ISM band at 2.4 GHz where any third party can
intercept the radio waves, willfully or accidentally, for any unknown purpose. 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.
3294330-0B_HEM-7530T-AP3-EN_IM.book Page 58 Thursday, June 2, 2022 11:30 AM
To Next Page
