CHOICEMMED AMERICA BP10 Arm type Fully Automatic Digital Blood Pressure Monitor Owner’s Manual

Owner’s Manual
Arm-type Fully Automatic
Digital Blood Pressure Monitor
Model : BP10
Ver 1.0

Safety Notice

Thank you for purchasing the BP10 Blood Pressure Monitor. The unit has been con- structed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use.
This device is intended for non-invasive measuring an adult individuals’ systolic, diastolic blood pressure and heart rate using the oscillometric method. The device is not intended for use on infants and children. The device is designed for home or clinical use. All values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm only. Please read this manual thoroughly before using the unit.
Please retain this manual for future reference. For specific information about your blood pressure, please

CONSULT YOUR DOCTOR.
To avoid risk and damage follow all warning precautions. Operate unit only as in- tended.Read all instructions prior to use.
Blood pressure measurement determined with this device are equivalent to those obtained by a trained observer using the cuff/ stethoscope auscultation method, within the limits prescribed by the American National Standard (ANSI/AAMI SP10) for electronic Sphygmomanometers.
WARNING SIGNS AND SYMBOLS USED

| Date of manufacturer
---|---
| Caution
| Type BF Equipment
| Serial Number
| Storage temperature and relative humidity
| Consult Instructions For Use

Safety Notice

1. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use.

2. Contact your physician if test results regularly indicate abnormal readings. Do not attempt to self-treat these symptoms without consulting your physician first.

3. Product is designed for its intended use only. Do not misuse in any way.

4. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician.

5. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition.

6. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important.

7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor.
   In certain cases oscillometric measurement method can produce incorrect readings

8. Product is not intended for infants or individuals who cannot express their intentions.

9. Do not disassemble or attempt to repair.

10. Do not use cell phones and other devices, which generate strong electrical or electromagnetic fields, near the device, as they may cause incorrect readings and interference or become interference source to the device.

11. Any hazards associated with prolonged overinflation of the bladder.

12. Only use a recommended AC adaptor complying with EN 60601-1 and EN 606011-2(see page 6). An unauthorized adaptor may cause fire and electric shock.

Battery Precautions
Do not mix new and old batteries simultaneously.
Replace batteries when Low Battery Indicator “ “ appears on screen.
Be sure battery polarity is correct.
Do not mix battery types. Long-life alkaline batteries are recommended.
Remove batteries from device when not in operation for more than 3 months.
Dispose batteries properly; observe local laws and regulations.

Unit Illustration

Arm Cuff

Contents

Important Testing Guidelines

1. Avoid eating, exercising, and bathing for 30 minutes prior to testing.
2. Sit in a calm environment for at least 5 minutes prior to testing.
3. Do not stand while testing. Sit in a relaxed position while keeping your arm level with your heart.
4. Avoid speaking or moving body parts while testing.
5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones.
6. Wait 3 minutes or longer before re-testing.
7. Try to measure your blood pressure at the same time each day for consistency.
8. Test comparisons should only be made when monitor is used on the same arm, in the same position, and at the same time of day.
9. This blood pressure monitor is not recommended for people with severe arrhythmia.

Any blood pressure recording can be affected by the following factors:

1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement.

Quick Start

1. Install batteries. (See Figure A )
2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
3. Remove thick clothing from the arm area.
4. Rest for several minutes prior to testing. Sit down in a quiet place, preferably at a desk or table, with your arm resting on a firm surface and your feet flat on the floor. (See Figure C )
5. Apply cuff to your left arm and keep level with your heart. Bottom of cuff should be placed approximately 1-2cm (0.4-0.8’’) above elbow joint. (See Figures D&E)
6. Press “START/STOP” Button to start testing.

Unit Operation

Battery Installation
Slide battery cover off as indicated by arrow.
Install 4 new AA alkaline batteries according to polarity.
Close battery cover.AC Adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V, 600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint.
Do not use any other type of AC adaptor as it may harm the unit. Time/Date Setting
With power off, press “START/STOP”button about 3 seconds to set the Time/Date mode.Set month first by adjusting the “MEM” butten, Press “STOP/START ”button setting the day, hour, and minute in same fashion.
Which in any setting mode..Press“START/ STOP”button to turn the unit off..All information will be saved.

Digital Blood Pressure Monitor
Note: if unit is left on and not in use for 3 minutes, it will automatically save all information and shut of . Applying the Arm Cuff

1. Firmly insert air plug into opening located on left side of monitor unit.
2. With sticky nylon section facing outward, insert end of cuff underneath metal ring of cuff
3. Fasten cuff about 1-2cm (0.4-0.8’’) above the elbow joint..For best results apply cuff to bare arm and keep level with heart while testing.

Note: Do not insert air plug into opening located on right side of monitor unit.
This opening is designed for an optional power supply only.
Testing

1. Power On
   Press and hold “ START/STOP “ button until a beep sounds. The LCD screen will appear for one second as unit performs a quick diagnosis. A long tone indicates device is ready for testing. Note: Unit will not function if residual air from previous testing is present in cuff.
   The LCD will flash “ “ until pressure is stabilized. .

2. Pressurization
   Initial pressure is first pumped to 190 mmHg. If the current user’s systolic blood pressure is over 190mmHg, the unit will automatically re-inflate to the proper shelf. Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press “ START/STOP ”button to turm the unit off.

3. Testing
   After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing “ “ will appear simultaneously on screen signaling heart beat detection. Note: Keep relaxed during testing. Avoid speaking or moving body parts.

4. Result Display
   Three short beeps sound when testing is complete. The screen will display measurements for systolic and diastolic blood pressure.

Note: Refer to Page 17 for detail Blood Pressure Information.
Power Off
The “ START/ STOP” button can be pressed to turn off the unit in any mode. The unit can turn off the power itself about 3 minutes no operation in any mode.
Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the “ START/STOP “ button to turn power off. The cuff pressure will rapidly dissipate once the unit is off.
Memory Check
With power off, press and hold “ MEM ” butten to turn the unit on. The LCD will display the last measurement memory as NO:1 reading . Older test result in  memiry can be viewed by pressing the “MEM” butten.

Memory Deletion
Which in memory check made. Press ” START/ STOP” and hold on for about 3 seconds to delete all history results and the LCD screen display“- – -” with beep sounds:Then press ” START/ STOP” button to turn off the unit.. Note: Memory cannot be recovered once it has been deleted.
Low Battery Indicator
4 short warning beeps sound when battery life is depleting and unable to inflate cuff for testing. The “ “ appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process.

Troubleshooting

Blood pressure results are not
within typical range| Cuff is too tight or not properly positioned on the arm| Firmly reposition cuff approximate- ly1-2cm1/2″ ( 1/2″) above the elbow joint ( See Page 11)
Inaccurate test results due to body movement or monitor movement| Sit in a relaxed position with arm placed near heart.. Avoid speaking or moving body parts while testing Make sure the monitor unit is placed in a stationary position throughout
the testing period.( See Page 8)
” Err “displayed| Cuff fails to inflate properly| Make sure hose is properly fastened to cuff and monitor unit
Improper operation| Read user manual carefully and re- test properly.
Pressurization is over 300mmHg| Read user manual carefully and re- test properly.

Blood Pressure Information

Blood Pressure
Blood pressure is the force of blood pushing against the walls of arteries. It is typically measured in millimeters of mercury (mmHg.) Systolic blood pressure is the maximumforce exerted against blood vessel walls each time the heart beats. Diastolic blood
pressure is the force exerted on blood vessels when the heart is resting between beats.
An individual’s blood pressure frequently changes throughout the course of a day.  xcitement and tension can cause blood pressure to rise, while drinking alcohol and bathing can lower blood pressure. Certain hormones like adrenaline (which your body releases under stress) can cause blood vessels to constrict, leading to a rise in blood pressure. If these measuring numbers become too high, it means the heart is working harder than it should.

Health Reminder
Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhag- ing. By maintaining a healthy lifestyle and visiting your physician on a regular basis,
hypertension and relative diseases are much easier to control when diagnosed in their early stages.

Note: Do not be alarmed if an abnormal reading occurs. A better indication of an individual’s blood pressure occurs after 2-3 readings are taken at the same time each day over an extended period of time. Consult your physican if test results remain abnormal.

Blood Pressure Q & A

Q: What is the difference between measuring blood pressure at home or at a professional healthcare clinic?

A: Blood pressure readings taken at home are now seen to give a more accurate account as they better reflect your daily life. Readings can be elevated when taken in a clinical or medical environment. This is known as White Coat Hypertension and may be caused by feeling anxious or nervous. Note: Abnormal test results may be caused by: 1. Improper cuff placement Make sure cuff is snug-not too tight or too loose. Make sure bottom of the cuff is approximately 1-2cm (1/2’’) above the elbow joint. 2. Improper body position Make sure to keep your body in an upright position. 3. Feeling anxious or nervous Take 2-3 deep breaths, wait a few minutes and resume testing.

Q: What causes different readings?

A: Blood pressure varies throughout the course of a day. Many factors including diet, stress, cuff placement, etc. may affect an individual’s blood pressure.

Q: Should I apply the cuff to the left or right arm? What is the difference?

A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm may provide more accurate results as it is located closer to your heart.

Q: What is the best time of day for testing?

A: Morning time or any time you feel relaxed and stress free.

Maintenance

1. Avoid dropping, slamming, or throwing the unit.

2. Avoid extreme temperatures. Do not expose unit directly under sunshine.

3. When cleaning the unit, use a soft fabric and lightly wipe with mild detergent. Use a damp cloth to remove dirt and excess detergent.

4. Cuff Cleaning: Do not soak cuff in water! Apply a small amount of rubbing alcohol to a soft cloth to clean cuff’s surface. Use a damp cloth (water-based) to wipe clean.
   Allow cuff to dry naturally at room temperature.

5. Do not use petrol, thinners or similar solvents.

6. Remove batteries when not in operation for an extended period of time.

7. Do not disassemble product.

8. It is recommended the performance should be checked every 2 years.

9. Expected service life: Approximately three years at 10 tests per day.

Specifications

Automatic Power-Off
Power Source| 4 AA batteries or  Medical AC Adapter(DC6.0V, 600mA) (recommended, not provided)
Battery Life| Approximately 2 months at 3 tests per day
Unit Weight| Approx.405g (14.30 oz.) (excluding battery)
Unit Dimensions| Approx.134 x 99 x 66mm (5.27” x 3.92” x 2.61” )(L x W x H)
Cuff Circumference| Approx.135 (W)×485(L) mm (Medium cuff: Fits arm circumference 22-36 cm)
Operating Environment| Temperature| 10℃ ~ 40℃ (50 ℉ ~104 ℉ )
Humidity| 15%-90% RH
Pressure| Atmospheric Pressure
Storage Environment| Temperature:| -20℃ ~55℃ (-4 ℉ ~131 ℉ )
Humidity| 15%-90% RH
Pressure| 525mmHg~795mmHg
Classification| Internal Powered Equipment, Type BF  ,Cuff is the Applied Part

This Blood Pressure Monitor complies with the European regulations and bears the CE mark “CE 0123”.This blood pressure monitor also complies with mainly following standards (included but not limited):
Safety standard:
60601-1 Medical electrical equipment part 1: General requirements for safety
standard:
60601-1-2 Medical electrical equipment part 1-2: General requirements for safety- Collateral standard: Electromagnetic compatibility- Requirements and tests Performance standards:
1060-1 Non-invasive sphygmomanometers – General requirements EN 1060-3 Non- invasive sphygmomanometers – Supplementary requirements for electromechanical blood pressure measuring systems.
1060-4 Non-invasive sphygmomanometers – Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.
Correct Disposal of This Product
Discard the used product to the recycling collection point according to local regulations.

Warranty

To obtain full warranty coverage, please be sure to complete your product registration. If you choose not to register your product, this Limited Warranty will be void.
ONLINE:
– Go to www.choicemmedamerica.com/register
– Fill out required information
MAIL:
– Complete the Warranty Registration Card
– Include a COPY of your sales receipt
– Send to: 2558 Pearl Buck Rd, Suite 8A, Bristol, PA 19007

Warranty Registration Card
Model No…………………………………………………
LOT#……………………………………………………
SN No……………………………………………………….
Purchase Name: ……………………………………………..
Purchase Date:…………………………………………………..
E-Mail:……………………………………………………………
Phone:……………………………………………………………….
Address 1:…………………………………………………………..
Address 2 :………………………………………………………
City/State : Zip:…………………………………………..

Warranty Conditions
ChoiceMMed America Co. warrants to the original purchaser that this equipment will be free from defects in materials and workmanship for a period of two years from the date of purchase. This warranty shall be limited to the repair adjustment and/or
replacement at the manufacturer’s option of defective parts free of charge except the cost of transportation to ChoiceMMed America Co. Manufacturer’s responsibility is limited to actual cost of item. When returning equipment for warranty service, all
shipping and insurance charges must be prepaid and the proof of purchase must be enclosed. A payment of $10.00 must be included to cover the return shipping and handling. Returns will only be shipped to locations within the USA. ChoiceMMed America Co. will not be responsible for expenses or inconveniences, or consequential damages occasioned by equipment or by breach of any expressed or implied warranty with respect thereto.
Limitations
This warranty covers all defects encountered in normal use of the equipment and does not apply in the following cases.

1. If the equipment has been serviced by other than a certified center.
2. Damage to the equipment due to mishandling, abuse, accident or failure to follow the operating instructions.
3. INSTRUMENTS: Warranty does not extend to display face, batteries and carrying case.
   Customer Service Representatives are available Monday through Friday – 9:30am to 4:30pm EST Service Phone: (215)-874-0458 www.choicemmedamerica.com

Distributed by:
ChoiceMMed America Co.
2558 Pearl Buck Road, Suite 8A
Bristol, PA 19007
© 2014 ChoiceMMed America Co.
Revised Date: November 24, 2014
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References

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