User's Manual

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
Thank you for purchasing the BELTER electronic sphygmomanometer
This product is a sphygmomanometer which uses noninvasive method to
measure human blood pressure.Please be sure to read the instructions
before use.After reading, please safekeeping for inspection at any time,
reference.
Scope of application: used for blood pressure and pulse measurement of
human body.
The sphygmomanometer is able to store up to 100 measurements per
user (maximum 2 users) and equipped with the Bluetooth Smart
technology to achieve reliable transmission linkage with a mobile device
or tablet PC that is with the logo and corresponding application. From
now on, you can easily track your health on a daily basis.
Referent Standards and Documents
No Standard Name Reference No.
1
Standard Name Reference No.
2
Medical Device Quality System for the regulation
requirement
EN ISO13485: 2012
3
Medical device risk management to medical devices
application
EN ISO14971: 2012
4
Symbol for the label of medical devices EN 980: 2008
5
Term, symbol and information of medical device—
information of medical device manufacturer offering
EN 1041: 2008
6
Medical electrical equipment – Part 1: General
requirements for safety
EN60601-1: 2006/AC:2010
7
Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and
tests
EN 60601-1-2: 2007
8
Clinical investigation of medical devices for human
subjects. General requirements
EN ISO 14155-1:2009
9
Clinical investigation of medical devices for human
subjects. Clinical investigation plans
EN ISO 14155-2:2009
10
Medical device software – Software life-cycle
processes
EN 62304: 2006/AC: 2008
11
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
EN 60601-1-6: 2010
12
Medical electrical equipment. Part 1-11:General
requirements for basic safety and essential
performance. Collateral standard:Requirements for
medical electrical equipment and medical electrical
EN 60601-1-11