Blood Pressure Monitor

Blood Pressure Monitor

Blood Pressure Monitor

TM

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Email: info

@greatergoods.com

Phone: (866) 991-8494

Website: greatergoods.com

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Table of Contents

IMPORTANT SAFETY INFORMATION p. 2

INTRODUCTION p. 3

DEVICE p. 4-5

SETTING TIME, DATE, AND MEASUREMENTS p. 6

TAKING MEASUREMENTS p. 7-8

MEMORY/MANAGING RECORDS p. 9-10

TIPS/MAINTENANCE p. 11

ABOUT BLOOD PRESSURE p. 12-14

TROUBLESHOOTING p. 15

DEVICE SPECIFICATIONS p. 16

COMPLIED STANDARDS LIST, FCC STATEMENT, EMC GUIDANCE p. 17

CONTACT INFORMATION & WARRANTY p. 18

Symbol for “THE OPERATION

GUIDE MUST BE READ”

Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE

DATE”

Symbol for “TYPE BF APPLIED

PARTS”

Symbol for “ENVIRONMENT

PROTECTION - Wast electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”

Safety/Caution Information

CAUTION

Consult your physician before measuring blood pressure, especially if you have any of

the following conditions: hypertension, diabetes, arteriosclerosis, kidney or vascular

disease, or any conditions affecting circulation.

Do not change medication use or dosage based on measurement from this device.

Take medication as prescribed by your physician. Only a physician is qualified

to diagnose and treat high blood pressure.

This device is not intended to be a diagnostic device.

This device is intended for adult use only. Keep the unit out of reach of infants,

children, or pets.

This device is not intended for use on extremities other than the arm or for functions

other than obtaining a blood pressure measurement. Do not use this device for any

other purpose.

Do not confuse self-monitoring with self-diagnosis. If you are taking medication,

consult your physician to determine the most appropriate time to measure your

blood pressure.

If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate.

Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the

cuff from the arm and press the START/STOP button to stop inflation.

The equipment is not AP/APG equipment and not suitable for use in the presence of

a flammable anesthetic mixture with air of with oxygen or nitrous oxide.

Do not touch battery output and the patient simultaneously.

Avoid strong electromagnetic field radiated interference signals or electrical fast

transient/burst signals.

This device is contraindicated for any female who may be suspected of, or is pregnant.

Besides provided inaccurate readings, the affects of this device on the fetus are

unknown.

This unit is not suitable for continuous monitoring during medical emergencies or

operations.

Do not disassemble or attempt to repair this device or any of its components. Doing so

will void the warranty.

Do not use this device near flammable gasses (anesthetic gas, oxygen, hydrogen) or

flammable liquids (alcohol) are present.

Use only HealthGurus™ authorized parts and accessories. Parts and accessories not

approved for use with this device may damage the unit.

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3

Introduction

Welcome to your new Health Gurus Blood Pressure Monitor.

We have designed this monitor to be as user friendly as possible to ensure that you can use it with ease.

This model detects your blood pressure measurement by using the oscillometric method, which turns your blood pressure into a digital reading. With the oscillometric method, no stethoscope is needed. The model also features blood pressure measurement, pulse rate measurement, a two-user mode, 60-entry memory storage, and a backlit LCD display for easy readability.

Please read the manual thoroughly before using this product.

CAUTION

1.

When using this device, pay attention to the following situation, which may interrupt blood flow and influence blood circulation of the patient, thus causing injury to the patient: too frequent and consecutive measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; or inflating the cuff on the arm on the side of a mastectomy.

2. Do not apply the cuff over a wound, otherwise it can cause further injury.

3.

Do not inflate the cuff on the same limb to which other monitoring ME

EQUIPMENT is applied because this could cause temporary loss of function of the monitoring ME EQUIPMENT.

4. Do not link the connection tube, otherwise, the cuff pressure may continuously increase, which can prevent blood flow and result in injury to the patient.

Device

Systolic blood pressure High pressure result

Diastolic blood pressure Low pressure result

Measurement unit of blood pressure kPa (kiloPascal) mmHg

(millimetres of mercury)

Pulse per minute

Measurement unit of blood pressure

Beats per minute (BPM)

Arrhythmia

Grade

Irregular heartbeat

Displays grade of blood pressure

Low batteries Batteries are low and need to be replaced

Memory

The displayed measurement values is from the memory feature

Current time

Deflating

User ID

Month/Day/Year – Hour/Minute

Cuff air is exhausting of deflating

Start measurement and save the results for USER 1 or USER 2

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Device (cont.)

Cuff

Air hose

Air connector plug

Memory/Up button

User/Down button

Start/Stop/Set button

LCD display

Battery compartment

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Installing and Replacing the Batteries

1. Open battery cover

2. Install the batteries by matching

the correct polarity, as shown.

*Always use AAA batteries.

3. Close the cover.

Replace the batteries whenever shows, the display dims, or when the display does not light up.

CAUTION

Remove batteries if the device is not likely to be used for some time.

The old battery is harmful to the environment. Do not dispose with other daily trash.

Remove the old battery from the device and follow your local recycling guidelines.

Do not dispose of batteries in fire. Batteries may explode or leak.

Setting Date, Time, and Measurement Unit

It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory.

1. When the display is off, hold the

“Start/Stop” button for about 3

seconds to enter set up mode.

2. Press the “UP” arrow (*MEM button)

to change the year, then press the

“SET” button to confirm the selection.

* The “MEM” and “USER” buttons function

as “UP” and “DOWN” secondary buttons

to navigate through information.

** The “Start/Stop” button also functions

as a “SET” button to confirm a selection.

3. Once you select “SET,” the next steps will

appear on the screen as the following:

4. After setup is complete, the screen will display “done”,

show each of the entered settings, and turn off.

The monitor is now ready to use.

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Measurements

Fastening the Cuff

1. Fasten the cuff on your upper arm,

then position the tube off-center

toward the inner side of the arm

in line with the little finger.

2. The cuff should be snug but not

too tight. You should be able to

insert one finger between the

cuff and your arm.

2~3cm

3. Sit comfortably with your

arm resting on a flat surface.

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The middle of the cuff should be at the level of the right atrium of the heart. Before starting the measurement, sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported.

IMPORTANT

Measurements (cont.)

Starting the Measurement

1. With the monitor off, press the

“Start/Stop” button to turn on

the monitor.

2. If necessary:

Toggle which user you want to

measure as by pressing the

“USER” button.

3. Press the “Start/Stop” button again.

The blood pressure monitor

will begin the reading and finish

the entire measurement.

4. Press the “Start/Stop” button to

power off, otherwise the monitor

will automatically turn off within

1 minute of the reading.

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Memory

Recalling Records

1. When the monitor is off,

press the “MEM” button.

2. If necessary:

Toggle which user you want to

view history for by pressing “USER.”

3. Press “MEM” once more, and the

average value of the last three

records show for that user.

4. Continue selecting entries or hold

the “MEM” button to scroll through

previous records quickly.

Press the “USER” button

to switch back and forth

between users.

Understanding Records

NOTE: The date and time of the

record will show alternately.

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The current memory number

The corresponding date is May 10th

The corresponding time is 10:08 P.M.

Memory (cont.)

Deleting Records

1. When the monitor is off, press the “MEM” button.

2. Select user, then hold down the

“MEM” and “Start/Stop” buttons

simultaneously.

3. When the “Del done” screen is

presented, all the records have

been erased. Then, the display

will turn off.

WARNING: This deletes all records.

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Tips/Maintenance

Tips for Measurement

It can cause inaccuracy if the measurement is taken under the following circumstances:

Measuring within 1 hour of eating or drinking

• Measuring after tea, coffee, or smoking

• Measuring within 20 minutes after taking a bath

• Measuring when talking or moving your fingers

• Measuring in a very cold environment

• Measuring when needing to use the restroom

Maintenance

In order to get the best performance out of your monitor, please follow the below instructions:

• Store monitor in a dry place

• Avoid contact with water, clean it with a dry cloth

if needed

• Do not attempt to clean the resizable cuff with water

• Never submerge monitor or cuff in water

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About Blood Pressure

What is the difference between systolic pressure and diastolic pressure?

When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

Systolic blood discharging artery press

What is the standard blood pressure classification?

The chart below is the standard blood pressure classification by the

American Heart Association (AHA).

Diastolic blood entering vein relax

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About Blood Pressure (cont.)

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies throughout the day.

It is also affected by the way you fasten your cuff and

your measurement position. Please make sure you

measure your blood pressure under the same

conditions each time you take a measurement.

2. Variations in the pressure can occur, due to certain

medicines being taken.

3. Waiting at least 3 minutes between measurements

is recommended.

Does it matter which arm I use when measuring?

It is acceptable to use either arm when measuring.

However, to obtain the most consistent readings possible, it is suggested that you use the same arm each time you measure your blood pressure.

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About Blood Pressure (cont.)

Why is the blood pressure I get from the hospital different from home?

Your blood pressure can vary throughout the day due to many factors such as weather, your emotions, exercise, etc.

When measuring your blood pressure at home, please check the following situations that could be causing a false measurement:

• The cuff is too loose or too tight

• The cuff is not secured properly

• Not placing the cuff correctly around the arm

• If you feel anxious, nervous, or are not relaxed

• Not resting your arm correctly

• Measuring too quickly after a previous reading

Irregular Heartbeat Detector

This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat Detector

(IHB). During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15, this equipment will light up the

IHB symbol on the screen when displaying the results.

CAUTION

The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

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Troubleshooting

Display will not light up.

Batteries are exhausted

Batteries are inserted incorrectly

Display is dim or

Batteries are low icon is showing

E1 shows on screen The cuff is not secure

Replace with new batteries

Insert the batteries correctly

Replace with new batteries

E2 shows on screen The cuff is too tight

E3 shows on screen

The pressure of the cuff is excessive

Refasten the cuff and then measure again

Readjust cuff to a comfortable fit and measure again

Relax for a moment and then measure again

E10 or E11 shows on screen

The monitor detected motion, talking, or the pulse is too poor while measuring

Relax for a moment and then measure again

E20 shows on screen

The measurement process does not detect the pulse signal

Loosen the clothing on the arm and then measure again

Relax for a moment and then measure again

EExx shows on screen

A calibration error occurred

Retake the measurement.

If the problem persists, contact our customer service department for further assistance.

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Device Specifications

Battery powered mode:

Power supply

Display mode

Measurement mode

Measurement range

Oscillographic testing mode

Rated cuff pressure:

0kpa - 40kpa (0mmHg~300mmHg)

Measurement pressure: 5.3kPa-30.7kPa

(40mmHg-230mmHg) pulse value: (40-199) beat/minute

Accuracy

Normal working condition

Storage & transportation condition

Measurement perimeter of the upper arm

Net Weight

External dimensions

Attachment

Mode of operation

Degree of protection

Protection against ingress of water

Atmospheric pressure: 86kPa to 106kPa

About 22cm~42cm

Approx.175 g(Excluding the dry cells)

Continuous operation

Type BF applied part

IP21

Software Version

V01

WARNING: No modification of this equipment is allowed.

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Standards List/FCC/EMC Guide

Complied Standards List

Risk management

Labeling

User manual

General

Requirements

For Safety

Electromagnetic compatibility

ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices

ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

EN 1041: 2008 Medical equipment manufacturers to provide information

IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC/EN 60601-1-2:2007 Medical electrical equipment -

Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests

Performance requirements and

Clinical Investigation

IEC 80601-2-30:2009 Medical electrical equipment- Part

2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers

Software life-cycle processes

IEC/EN 62304:2006+AC: 2008 Medical device software

- Software life cycle processes

FCC Statement

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.

EMC Guidance

1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.

2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect this equipment and should be kept at least a distance d=3, 3m away from the equipment.

(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)

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Contact and Warranty

Contact Information

Distributed by:

Greater Goods LLC.

125 N Main St

Suite 202

St Charles, MO 63301

[email protected]

(toll free) 866-991-8494 greatergoods.com

Warranty Information

Your Blood Pressure Monitor is warranted by the manufacturer against defects in materials and workmanship for two (2) years from the original purchaser from the date of purchase. Proof of purchase is required.

The warranty is void if the product has been subjected to mechanical damage or mistreatment, such as immersion. This warranty is in lieu of all other warranties, and limits the liability of the manufacturer.

This warranty gives you certain legal rights and you may have other rights depending on which state the product was purchased.

Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd

Company: Guangdong Transtek Medical Electronics Co., Ltd

Address: Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch

Development District, Zhongshan, Guangdong, 528437, China

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