Andon Kd-752 User manual

DN:KD-752-SMSY01 V1.0 Operation Guide

History Revision

Revision

date

Revision

Description

Versi

Drafter

Approver

2018-10-25

Originated

V1.0

Zhang RuoShang

Zhang Fei

DN:KD-752-SMSY01 V1.0 Operation Guide

Operation Guide

(V1.0)

Product/project name：Wireless Blood Pressure

Monitor

Model name：KD-752

Project number：2017-007-XY13

Drafted by: Date

Reviewed by: Date

Approved by: Date

DN:KD-752-SMSY01 V1.0 Operation Guide

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MODEL KD-752

Wireless Blood Pressure Monitor

(ELECTRONIC SPHYGMOMANOMETER)

OPERATION GUIDE

__________________________________________________________________________

INDEX

IMPORTANT INFORMATION .........................................................................2

CONTENTS AND DISPLAY INDICATORS.....................................................2

INTENDED USE..............................................................................................3

PACKAGE CONTENTS ..................................................................................3

CONTRAINDICATION.....................................................................................3

PRODUCT DESCRIPTION..............................................................................3

SPECIFICATIONS...........................................................................................4

NOTICE ...........................................................................................................4

SETUP AND OPERATING PROCEDURES....................................................6

1. BATTERY LOADING ..................................................................................6

2. CLOCK AND DATE ADJUSTMENT ...........................................................7

3. VOICE SETTING.........................................................................................8

4. CONNECTING THE CUFF TO THE MONITOR..........................................9

5. APPLYING THE CUFF................................................................................9

6. BODY POSTURE DURING MEASUREMENT..........................................10

7. TAKING YOUR BLOOD PRESSURE READING......................................10

8. DISPLAYING STORED RESULTS ...........................................................11

9. SYNCHRONIZING STORED RESULTS ...................................................13

10. DELETING MEASUREMENTS FROM THE MEMORY...........................13

11. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS .......................13

12. TECHNICAL ALARM DESCRIPTION.....................................................14

13. TROUBLESHOOTING (1).......................................................................14

14. TROUBLESHOOTING (2).......................................................................14

MAINTENANCE ............................................................................................16

EXPLANATION OF SYMBOLS ON UNIT.....................................................16

WARRANTY INFORMATION........................................................................17

SERVICE CENTER .......................................................................................17

ELECTROMAGNETIC COMPATIBILITY INFORMATION............................18

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IMPORTANT INFORMATION

NORMAL BLOOD PRESSURE FLUCTUATION

All physical activity, excitement, stress, eating, drinking, smoking, body posture and many

other activities or factors (including taking a blood pressure measurement) will influence blood

pressure value. Because of this, it is mostly unusual to obtain identical multiple blood pressure

readings.

Blood pressure fluctuates continually ----- day and night. The highest value usually appears in

the daytime and lowest one usually at midnight. Typically, the value begins to increase at

around 3:00 AM, and reaches to highest level in the daytime while most people are awake and

active.

Considering the above information, it is recommended that you measure your blood pressure

at approximately the same time each day.

Too frequent measurements may cause injury due to blood flow interference, please always

relax a minimum moment of 1 to 1.5 minutes between measurements to allow the blood

circulation in your arm to recover. It is rare that you obtain identical blood pressure readings

each time.

CONTENTS AND DISPLAY INDICATORS

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INTENDED 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 inflatable cuff is wrapped around the wrist. The cuff circumference is

limited to 14cm-19.5cm(approx. 5 1/2″-7 11/16″).

PACKAGE CONTENTS

1 Wireless Blood Pressure Monitor With Attached Wrist Cuff

1 Operation Guide

1 Storage Case

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 4×60 measurements can be stored in the

memory with date and time stamp. The Electronic Sphygmomanometer corresponds to the

below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical

electrical equipment -- Part 1: General requirements for basic safety and essential

performance), IEC60601-1-2:2014/EN 60601-1-2:2015 (Medical electrical equipment -- Part

1-2: General requirements for basic safety and essential performance - Collateral standard:

Electromagnetic compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1：

2013/EN 80601-2-30:2010/A1：2015(Medical electrical equipment –Part 2-30: Particular

requirements for the basic safety and essential performance of automated non-invasive

sphygmomanometers)EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers -

Part 1: General requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive

sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood

pressure measuring systems);ISO81060-2 ：2013(Non-Invasive Sphygmomanometers - Part

2: Clinical Validation Of Automated Measurement Type).

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SPECIFICATIONS

1. Product name: Wireless Blood Pressure Monitor

2. Model: KD-752

3. Classification: Internally powered, Type BF applied part,IP22,No AP or APG, Continuous

operation

4. Machine size: Approx. 100mm×70mm×23.5mm( 3 15/16″x 2 3/4″x 7/8″)

5. Cuff circumference:14cm-19.5cm(approx. 5 1/2″-7 11/16″)

6. Weight: Approx. 80g (2 13/16oz.) (exclude batteries and cuff)

7. Measuring method: Oscillometric method, automatic inflation and measurement

8. Memory volume: 4×60 times with time and date stamp

9. Power source: batteries: 2x1.5V SIZE AAA

10. Measurement range:

Cuff pressure: 0-300mmHg

Systolic: 60-260mmHg

Diastolic: 40-199mmHg

Pulse rate: 40-180 beats/minute

11. Accuracy:

Pressure: ±3mmHg

Pulse rate: Less than 60: ±3bpm

More than 60 (incl.) : ±5%

12. Environmental temperature for operation: 10℃～40℃(50℉～104℉)

13. Environmental humidity for operation: ≤85%RH

14. Environmental temperature for storage and transport: -20℃～50℃(-4℉～122℉)

15. Environmental humidity for storage and transport: ≤85%RH

16. Environmental pressure: 80kPa-105kPa

17. Battery life: Approx 120 times.

18. Wireless Connection:

Smart Bluetooth

Frequency Band: 2.400~2.4835GHz

19. All components belonging to the pressure measuring system, including accessories:

Pump,Valve, LCD, Cuff, Sensor

Note: These specifications are subject to change without notice.

NOTICE

1. Read all of the information in the operation guide and any other literature in the box before

operating the unit.

2. Stay still, calm and rest for 5 minutes before blood pressure measurement.

3. The cuff should be placed at the same level as your heart.

4. During measurement, neither speak nor move your body and arm.

5. Measuring onsame wrist for each measurement.

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6. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood

circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300

mmHg or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause

ecchymoma of your arm.

7. Consult your physician if you have any doubt about below cases:

1) The application of the cuff over a wound or inflammation diseases;

2) The application of the cuff on any limb where intravascular access or therapy, or an

arterio-venous (A-V) shunt, is present;

3) The application of the cuff on the arm on the side of a mastectomy;

4) Simultaneously used with other monitoring medical equipments on the same limb;

5) Need to check the blood circulation of the user.

8. This Electronic Sphygmomanometer is designed for adults and should never be used

on infants or young children. Consult your physician or other health care professionals

before use on older children.

9. Do not use this unit in a moving vehicle, This may result in erroneous measurement.

10. Blood pressure measurements determined by this monitor are equivalent to those

obtained by a trained observer using the cuff/stethoscope auscultation method, within the

limits prescribed by the American National Standard Institute, Electronic or automated

sphygmomanometers.

11. Information regarding potential electromagnetic or other interference between the wireless

blood pressure monitor and other devices together with advice regarding avoidance of

such interference please see part ELECTROMAGNETIC COMPATIBILITY

INFORMATION. It is suggested that the wireless blood pressure monitor be kept 10

meters away from other wireless devices, such as WLAN unit, cell phone, microwave oven,

etc.

12. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure

of blood pressure measurement, a signal of will be displayed. Under this condition,

the Electronic Sphygmomanometer can keep function, but the results may not be accurate,

it’s suggested that you consult with your physician for accurate assessment.

There are 2 conditions under which the signal of IHB will be displayed:

1) The coefficient of variation (CV) of pulse period >25%.

2) The difference of adjacent pulse period≥0.14s, and the number of such pulse takes

more than 53 percentage of the total number of pulse.

13. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring

biocompatible hazard and might result in measurement error.

14. The monitor might not meet its performance specifications or cause safety hazard if

stored or used outside the specified temperature and humidity ranges in specifications.

15. Please do not share the cuff with other infective person to avoid cross-infection.

16. This equipment has been tested and found to comply with the limits for a Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation. This

equipment generates, uses and can radiate radio frequency energy and, if not installed

and used in accordance with the instructions, may cause harmful interference to radio

communications. However, there is no guarantee that interference will not occur in a

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particular installation. If this equipment does cause harmful interference to radio or

television reception, which can be determined by turning the equipment off and on, the

user is encouraged to try to correct the interference by one or more of the following

measures:

—Reorient or relocate the receiving antenna.

—Increase the separation between the equipment and receiver.

—Connect the equipment into an outlet on a circuit different from that to which the

receiver is connected.

—Consult the dealer or an experienced radio/TV technician for help.

17. Measurements are not possible in patients with a high frequency of arrhythmias.

18. The device is not intended for use on neonates, children or pregnant women. (Clinical

testing has not been conducted on neonates, children or pregnant women.)

19. Motion, trembling, shivering may affect the measurement reading.

20. The device would not apply to the patients with poor peripheral circulation, noticeably low

blood pressure, or low body temperature (there will be low blood flow to the measurement

position).

21. The device would not apply to the patients who use an artificial heart and lung (there will

be no pulse).

22. Consult your physician before using the device for any of the following conditions:

common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,

arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, renal diseases.

23. The patient can be an intended operator.

24. This device complies with part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) This device may not cause harmful interference, and (2) this device

must accept any interference received, including interference that may cause undesired

operation.

25. Attention that changes or modification not expressly approved by the party responsible for

compliance could void the user’s authority to operate the equipment.

26. Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries

and the unit out of the reach of children and disabled persons.

27. If you are allergic to plastic/rubber, please don’t use this device.

SETUP AND OPERATING PROCEDURES

1. BATTERY LOADING

a. Press the battery cover with your finger and push hard in the direction of the arrow.

Remove the battery cover on the lower left side of the device. See picture 1-1.

b. Insert two “AAA” size batteries. Make sure that the batteries are insert-ed with the

correct polarity, according to the label on the battery compartment lid. See picture

1-2.

c. Replace the battery cover carefully. See picture 1-3.

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Picture 1-1 Picture 1-2 Picture 1-3

When LCD shows battery symbol , replace all batteries with new ones.

Rechargeable batteries are not suitable for this monitor.

Remove the batteries if the monitor will not be used for a month or more to avoid

relevant damage of battery leakage.

Avoid the battery fluid to get in your eyes. If it should get in your eyes, immediately

rinse with plenty of clean water and contact a physician.

The negative terminal of the battery needs to be compressed into the battery

compartment properly after horizontal compression of the negative electrode. The battery

is in contact with the spring.

Make sure the battery cover is intact and not damaged before installing the battery.

The monitor, the batteries and the cuff, must be disposed of according to local

regulations at the end of their usage.

2. CLOCK AND DATE ADJUSTMENT

a. Once you install the battery, it will enter Clock Mode, and LCD will display time and

date. See picture 2-1. The monitor will enter Standby Mode after 10 seconds with no

operation.

b. While the monitor is in Clock Mode or Standby Mode, press the “START” and “MEM”

button simultaneously for two seconds, then release the buttons, the monitor will be

in Clock and Date Adjustment Mode.

c. In Clock and Date Adjustment Mode, the time format will blink at first. See picture 2-2.

While time format is blinking, press the button “MEM” to change the time format. The

default time format is 24h.

d. Press the button “START” repeatedly, the year (range is 2019~2099), month, day,

hour and minute will blink in turn. See picture 2-3 & 2-4 & 2-5 & 2-6 & 2-7. While the

number is blinking, press the button “MEM” to increase the number, keep on

pressing the button "MEM", the number will increase faster.

e. During adjusting clock and date, the monitor will turn off automatically after 1 minute

with no operation.

f. You can turn off the monitor by pressing “START” button when the minute is blinking,

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then the time and date is confirmed.

Picture 2-1 Picture 2-2 Picture 2-3 Picture 2-4

Picture 2-5 Picture 2-6 Picture 2-7

Note:

2.1 The clock format could be set by user.

2.2 Table 2-1 instructs the conversion relations between 24 hour format and 12 hour

format. Table 2-1

24 hour format

12 hour format

24 hour format

12 hour format