Shenzhen Belter Health Measurement and Analysis Technology Co. Ltd. EPA46B ユーザーズマニュアル
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.
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.
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.
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
requirement
EN ISO13485: 2012
3
Medical device risk management to medical devices
application
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
information of medical device manufacturer offering
EN 1041: 2008
6
Medical electrical equipment – Part 1: General
requirements for safety
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
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
subjects. General requirements
EN ISO 14155-1:2009
9
Clinical investigation of medical devices for human
subjects. Clinical investigation plans
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
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
performance. Collateral standard:Requirements for
medical electrical equipment and medical electrical
EN 60601-1-11