9
Specifications
Pintended Use
Fully Automatic Electronic Sphygmomanometer 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 inatable
cuff is wrapped around the upper arm or 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 LCD display will show blood pressure and pulse rate.The
most recent 2x60 measurements can be stored in the memory with date and time stamp. The monitor can
also show the average reading of the last three measurements. The voice function will ease the operation.
The Electronic Sphygmomanometers 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 com-
patibility - 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.
1. Classification: Internally powered, Type BF
applied part, IPX0, No AP or APG, Continuous
operation.
Machine size:
Arm type: Approx. 147 mm x 105mm x 76mm
(5 25/32”x 4 1/8”x 3”) Wrist type: 87 mm x 70
mm x 29 mm (3 7/16” x 2 3/4” x 1 5/32”)
2. Cuff circumference: Arm type: 22 cm-30 cm
(8 21/32"-11 13/16"), 30 cm-42cm (11 13/16" -
16 17/32") (Optional), 42cm-48cm (16 17/32"-
18 29/32") (Optional) Wrist type: 14 cm - 19.5
cm (5 1/2” - 7 11/16”) 2. Weight: Arm type
Approx. 313g (11 1/32 oz.) (exclude batteries
and cuff) Wrist type Approx. 133g (4 11/16oz.)
(exclude batteries)
3. Measuring method: Oscillometric method,
automatic inflation and measurement
4. Memory volume: 2 x 60 times with time and
date stamp
5. Power source: Arm type: DC:6V 600mA,
batteries: 4 x 1.5V SIZE AA Wrist type: batteries:
2 x1.5V SIZE AAA
6. Measurement range: Cuff pressure: 0-300
mmHg Systolic: 60-260 mmHg Diastolic: 40-199
mmHg Pulse rate: 40-180 beats/minute
7. Accuracy: Pressure: ±3mmHg Pulse rate: ±5%
8. Environmental temperature for operation:
5°C~40°C (41°F~104°F)
9. Environmental humidity for operation:
≤90%RH 1
0. Environmental temperature for storage
and transport: -20°C~55°C (-4°F~131°F)
11. Environmental humidity for storage and
transport: ≤90%RH
12. Environmental pressure: 80kPa -105kPa 13.
Battery life: Arm Type: Approx 360 times. Wrist
type: Approx 120 times
14. A list of all components belonging to the
pressure measuring system, including accessories:
Pump, Valve, LCD, Cuff, Sensor
Note: These specifications are subject to change
without notice.
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