DN:KD-7961N-SMSY01 V3.0
Operation Guide
Template version:1
3/15
INTENDED USE
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a
non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood
pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is
wrapped around the wrist.
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer.
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure and pulse rate can
be measured automatically and non-invasively. The most recent 60 measurements can be stored in the memory
with date and time stamp. The voice function will ease the operation. The Electronic Sphygmomanometer
corresponds to the below standards:IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical equipment
-- Part 1: General requirements for basic safety and essential performance), IEC60601-1-2:2007/EN
60601-1-2:2007 /AC:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC
80601-2-30
：
2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment
–Part 2-30: Particular
requirements
for
the
basic
safety
and
essential
performance
of
automated
non-invasive
sphygmomanometers)EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1:
General requirements), EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring systems), ANSI/AAMI
SP-10:2002+A1:2003+A2:2006.
SPECIFICATIONS
1. Product name: Blood Pressure Monitor
2. Model: KD-7961N
3. Classification: Internally powered, Type BF applied part,IPX0,No AP or APG, Continuous operation
4. Machine size: 85mm x 69mm x 30mm ( 3 11/3
2″ x 2 23/32″ x 1 3/16″)
5.
Cuff circumference: 14cm ~ 19.5cm(5 1/2″~ 7 11/16″)
6. Weight: approx. 134g (4 23/32oz.) (exclude batteries and cuff)
7. Measuring method: oscillometric method, automatic air inflation and measurement
