HoMEDiCS BPW-O200 Wrist Blood Pressure Monitor Instruction Manual

Wrist Blood Pressure Monitor
INSTRUCTION MANUAL
BPW-O200

IMPORTANT PRODUCT NOTICES AND SAFETY INSTRUCTIONS

When using your blood pressure monitor, basic precautions should always be followed. Please read and follow all instructions and warnings before using this product. Save these instructions for future reference.

• Please note that this is a home healthcare product only and it is not intended to serve as a substitute for the advice of a physician or medical professional.
• This device uses oscillemetric method to measure systolic and diastolic blood pressure, as well as heart rate.
• Do not use this device for diagnosis or treatment of any health problem or disease. Measurement results are for reference only. Consult a healthcare professional for interpretation of pressure measurements. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or healthcare professional.
• This product is not suitable for people with arrhythmias. This device may have difficulty determining the proper blood pressure for pregnant women, and for users with irregular heartbeat, diabetes, poor circulation of blood, kidney problems, or for users who have suffered a stroke.
• Not suitable for those undergoing intravenous injection on any limb or women with pre-eclampsia.
• For those who have undergone mastectomy or lymph nodectomy surgery, it is recommended to take a measurement on the unaffected side.
• Excessive use may result in blood flow interference, which is likely to cause uncomfortable sensations, such as partial subcutaneous hemorrhage, or temporary numbness to your wrist. In general, these symptoms should not last long. However, if you do not recover in time, please seek advice from a medical professional.
• The pulse display is not suitable for checking the frequency of heart pacemakers.
• Electromagnetic interference: The device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g., mobile telephones, microwave ovens). These may lead to temporary impairment of measurement accuracy.
• When used among medical electronic equipment on the same limb, pressurization of the cuff may cause the other devices to temporarily malfunction.
• Please use this device indoors only, in a home healthcare environment.
• Use blood pressure monitor only for its intended use.
• Do not wrap the cuff around body parts other than your wrist.
• Not for use by or on persons under the age of 18.
• Do not use this device on infants, children, or those who cannot express their own intention.
• Please use only the 1.5V AAA alkaline batteries for power supply.

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method within the accuracy limits prescribed by the American National Standard for manual, electronic, or automated sphygmomanometers.

ABOUT BLOOD PRESSURE

What is blood pressure?
Blood pressure is the pressure exerted on the artery walls while blood flows through the arteries. The pressure measured when the heart contracts and sends blood out of the heart is systolic (highest) blood pressure. The pressure measured when the heart dilates with blood flowing back into the heart is called diastolic (lowest) blood pressure.
Why measure your blood pressure?
Among today’s various health problems, those associated with high blood pressure are very common. High blood pressure dangerously correlates with cardiovascular diseases. Therefore, blood pressure monitoring is important for identifying those at risk.
Why do my readings vary?
Blood pressure is a body parameter that is subject to normal variations throughout the day. A single reading that is different from your and your doctor’s readings are not necessarily inaccurate. The average of several readings, taken under similar conditions, using the same arm, is preferred for accurate blood pressure readings.
Why are my readings different than those taken at my doctor’s office?
Many experience a phenomenon called “White Coat Hypertension” when measured by a doctor. White Coat Hypertension refers to blood pressure that rises above its usual level when measured in a clinical setting, such as a doctor’s office.

BLOOD PRESSURE STANDARD

The table below contains defined levels of hypertension that are publicly available from the American Heart Association® (AHA 2017) (www.heart.org/HEARTORG/Conditions/HighBloodPressure/KnowYourNumbers /UnderstandingBlood-Pressure- Readings_UCM_301764_Article.jsp#.WusfWogvy71). Users can compare their own blood pressure readings against these defined levels to determine if they may be potentially at increased risk.
This table is applicable to most adults age 18 and older.

Blood Pressure Category| Systolic mm Hg.
(upper number)| | Diastolic mm Hg (lower number| LED Indicator Color
---|---|---|---|---
Normal| <120| and| <80| Green
Elevated| 120-129| and| <80| Yellow
High Blood Pressure (hypertension) Stage 1| 130-139| or| 80-89|
High Blood Pressure (hypertension) Stage 2| 140-180| or| 90-120| Red
Hypertension Crisis (consult your doctor immediately)| >180| and/or| >120|

Blood pressure tends to go up and down, even in people who normally don’t have high readings. If your numbers stay above the “normal” range most of the time, you may be at increased risk and should consult your physician.
Although one can easily find where their own blood pressure readings fall on this table, this monitor comes equipped with a Risk Category Index that automatically compares each reading to the defined levels and provides a helpful cue if your reading falls into one of the stages that could potentially indicate an increased risk.
Please note that cues provided by this monitor are only intended to assist you in using this table. The table and cues are only provided for convenience to help you understand your non-invasive blood pressure reading as it relates to the AHA 2017 information. They are not a substitute for a medical examination by your physician. It is important for you to consult with your physician regularly. Your physician will tell you your normal blood pressure range as well as the point at which you may actually be considered to be at risk.

NAME/FUNCTION OF EACH PART

BATTERY INSTALLATION

1. Slide the battery cover to open.
2. Install or replace 2 AAA alkaline batteries in the battery compartment. Make sure the polarities “+” and “-” ends coincide with similar markings inside the compartment.
3. Close the battery cover by sliding back into place.

Replace the batteries if:

• The low battery symbol appears on the display.
• Nothing appears on the display when the power is switched on.

NOTE:

• Date and time must be reset if batteries are removed or replaced.
• Replace all batteries at one time (as simultaneous set). Use only 1.5V AAA alkaline batteries.
• When the batteries are removed, the measurement values stored in memory are retained.
• Clean contacts on battery and in battery compartment with a soft, dry cloth each time you install batteries.
• Batteries are hazardous waste. Do not dispose of them together with household garbage.

DATE AND TIME SET

Press the DATE/TIME SET button and the YEAR will flash on the screen. Press USER/+ button to increase to desired YEAR; press DATE/TIME SET button to confirm. Repeat steps for MONTH, DAY, HOUR, and MINUTE.

DISPLAY EXPLANATIONS

| Low Battery Symbol: Appears when batteries should be replaced.
---|---
| Pulse Symbol: Shows the heart rate per minute.
| Risk Category Indicator: See Blood Pressure Standard section for more information.
| Irregular Heartbeat Detector: See below for more information.
| Memory Average: Displays average of last 3 readings.
EE| Measurement Error:  Adjust the cuff and keep wrist steady during measurement.

IRREGULAR HEARTBEAT DETECTOR

The appearance of the 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. Movement, shaking, or talking during the measurement can result in pulse irregularities that may cause the appearance of this icon. Therefore, it is of great importance to not move or talk during measurement.
To determine the presence of an irregular heartbeat, the average of the heartbeat intervals is calculated with the first 3 normal effective heartbeat values. It is important to note that the average is not a strict mathematical averaging of all recorded intervals. At least 3 beats with 25% or greater difference from the average heartbeat interval will generate the icon on the screen.

USING THE WRIST CUFF

1. Wrap the cuff snugly around the left wrist with palm facing up and the monitor facing you. Do not make too tight.
2. Fold the remaining part of the wrist cuff back out of the way.
3. Make sure that you leave approximately 1/4” to 1/2” from the palm and that there is not extra space between the cuff and wrist.

MEASUREMENT PROCEDURE

IMPORTANT:
It is extremely important that the cuff be at the same height as the heart. Having the cuff higher or lower may cause inaccurate results.
BEFORE MEASUREMENT

• Wait 1 hour after exercising, bathing, eating, drinking alcoholic or caffeinated beverages, or smoking before taking a measurement.
• Sit quietly and rest for 15 minutes; for any subsequent measurements, it is recommended to wait a minimum of 5 minutes.
• Take your blood pressure at normal body temperature.

DURING MEASUREMENT

• Do not talk or move your arm or hand muscles.
• Do not cross your legs. Sit with feet flat on the floor.
• Do not touch cuff or monitor during measurement.
• Position the blood pressure monitor on your wrist.
• Place your elbow on the table and rest the back of your hand on the device storage case or other object.
• Rest your wrist on the armrest until it’s at the same height as your heart.
• Relax your hand and turn your palm upward.
• Do not use this device if your wrist has any wound or injury.
• Once the measurement has started, keep your wrist steady until the measurement is complete.

1. Press START/STOP button to turn the monitor ON.
2. Press USER/+ button to choose User 1 or 2.
3. With the cuff wrapped around your wrist, press the START/STOP button. Do not inflate the cuff unless it is wrapped around your wrist. All digits will light up to check the display function. The checking procedure will be completed after about 1.5 seconds.
4. After all symbols disappear, the display will show “00”. The monitor is “Ready to Measure” and will automatically inflate the cuff to begin measurement.
5. When the measurement is completed, the cuff will deflate entirely. Systolic pressure, diastolic pressure, and pulse will be shown simultaneously on the LCD screen. The measurement is then automatically stored into memory.

NOTE:

• This monitor automatically turns off approximately 1 minute after last operation. You may also press the START/STOP button to turn the unit off.
• To interrupt the measurement, you may press the START/STOP button. The cuff will deflate immediately after a button is pressed.

RECALLING VALUES FROM MEMORY

This monitor can be used by 2 individuals. Each user can store up to 30 measurements.

1. Press USER/+ button to select User 1 or 2.
2. Press MEM button to access the Memory.
3. If there is no data stored in memory, nothing (except for month, date, and time) will appear on the display. If there is data, the first reading will be the average of the last 3 measurements.
4. Every new press of the MEM button will recall a previous reading. The latest reading will be recalled first.
5. To stop recalling readings from memory, press the START/STOP button.

CLEARING VALUES FROM MEMORY

1. Press USER/+ button to select User 1 or 2.
2. Press MEM button to access the Memory.
3. Press and hold the DATE/TIME SET buttons ( USER/+) at the same time while in memory recall mode, and the data for the selected user will be erased automatically.

Note: Once deleted, your readings cannot be restored.

CARE, MAINTENANCE, AND CLEANING

• Clean the blood pressure monitor body and cuff carefully with a slightly damp, soft cloth. Do not press. Do not wash cuff or use chemical cleaner on it. Never use thinner, alcohol, or petrol (gasoline) as cleaner.
• Leaky batteries can damage the unit. Remove the batteries when the unit will not be used for a long time.
• Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
• If the unit is stored near freezing, allow it to acclimate to room temperature before use.
• This blood pressure monitor is not field-serviceable. You should not use any tool to open the device nor should you attempt to adjust anything inside the device. If you have any problems with this device, please contact HoMedics Consumer Relations (contact information can be found on the Warranty page).
• Do not immerse the unit in water as this will result in damage to the unit.
• Do not subject the monitor or cuff to extreme temperatures, humidity, moisture, or direct sunlight. Protect from dust.
• Do not fold the cuff and tubing tightly.
• Do not disassemble the monitor or cuff. If in need of repair, refer to the Warranty section of this manual.
• Do not subject the monitor to extreme shocks (do not drop on floor).
• Do not inflate the cuff unless wrapped around wrist.
• Do not wrap the cuff around body parts other than your wrist.
• Do not drop or insert any object into any opening or hose.
• Always store the unit in the storage case between uses.
• This monitor may not meet its performance specifications if stored outside these temperature and humidity ranges:

Storage/Transportation Environment
Temperature: -13°F ~ 158°F (-25°C ~ 70°C)
Humidity: less than 93% RH
Operating Environment
Temperature: 41°F ~ 104°F (5°C ~ 40°C)
Humidity: 15% ~ 93% RH

TROUBLESHOOTING

If any abnormality arises during use, please check the following points.

batteries in the correct positions.
EE measurement error
symbol shown on display or the blood pressure value is displayed excessively
low (or high).| The wrist cuff has been positioned on the arm incorrectly.| Re-wrap the cuff properly so that it is positioned correctly. Take new measurement.
Did you talk or move during measurement?| Keep arm steady during measurement. Measure again. Refer to “Measurement Procedure” instructions.
Shaking of the arm with the cuff on.
El error symbol shown on display.| Air circuit abnormality. Cuff tube may not be plugged into monitor correctly.| Check cuff connection. Take new measurement. See “Using the Wrist Cuff” section.
E2 error symbol shown on display.| Inflation pressure exceeding 300 mmHg.| Switch the unit off and then turn back on. Take new measurement.
E3 error symbol shown on display.| Error determining measurement data.| Re- wrap the cuff properly so that it is positioned correctly. Take new measurement.
EP error symbol shown on display.| System error.| Remove batteries. After 1 minute, re-insert the batteries. Take new measurement.

Note: If the unit still does not work, contact HoMedics Consumer Relations. Under no circumstance should you disassemble or attempt to repair the unit by yourself. Contact information for HoMedics Consumer Relations can be found on the Warranty page.

SPECIFICATIONS

Pulse: 40-199 beats/minute
Rated Range of Determination:| 40-280 mmHg
Accuracy:| Pressure: ±3 mmHg
Pulse: +5% Max.
Pressure Sensor:| Semi-conductor
Inflation:| Automatic inflation (air pump)
Deflation:| Automatic air release control valve
Display:| Liquid Crystal Display
Memory:| 60 memory total for 2 users
Unit Dimensions:| 75 x 75 x 26 mm (Lx Wx H)
2.95 x 2.95 x 1.02 inch (L x W x H)
Unit Weight:| 79.5 g + 5 g (2.80 oz + 0.18 oz)
(without cuff and batteries)
Cuff Size:| 135 — 195 mm (approx. 5.3 — 7.7 inch)
Storage/Transportation
Environment:| Temperature: -25°C — 70°C (-13°F — 158°F)
Humidity: < 93% RH
Operation Environment:| Temperature: 5°C — 40°C (41°F-104°F)
Humidity: 15% — 93% RH
Atmospheric pressure:| 700 hPa — 1060 hPa
Power Supply:| DC 3 V, AAA “LR03” (1.5 V) alkaline battery x 2
Battery Life:| Approx. 250 measurements
Product Life:| 5 years (4 times a day)
Sleeping Mode:| Without any operation for 1 minute, device
automatically shuts off
Accessories:| Instruction manual, storage case, 2 AAA (LR03) alkaline batteries
| Internally powered equipment
Type BF equipment
IP22-degrees of protection provided by enclosures
Not suitable for use in presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Continuous operation with short-time loading.
| Follow instructions for use.

Note: These specifications are subject to change without notice.
POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE
To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipment, do not use the device near a cell phone or microwave oven. For most wireless communication devices, it is recommended to maintain a distance of 10.8 feet (3.3m) in order to avoid electromagnetic interference. 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. FEDERAL COMMUNICATIONS COMMISSION COMPLIANCE STATEMENT
Changes or modifications to this equipment not expressly approved by the manufacturer could void the user’s authority to operate the equipment. 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 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.

ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:

Emissions test| Compliance| Electromagnetic environment – guidance
---|---|---
RF emissions CISPR 11| Group 1| RF energy is used only to maintain device’s operation.
Therefore, its RF emissions are so low that it’s not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Not
Applicable| The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/flicker emissions IEC 61000-3-3| Not
Applicable

Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
---|---|---|---
Electrostatic discharge (ESD)
IEC 610004-2| ± 8 kV contact discharge
± 15 kV air discharge| ± 8 kV contact discharge
±15 kV air discharge| The relative humidity should be at least 5%
Power frequency magnetic field
IEC 610004-8| 30 A/m
50 or 60 Hz| 30 A/m
50 or 60 Hz| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Recommended separation distance

where I is the current in amperes in a power bus or an appliance wire and r is the recommended separation distance between your device and the power bus or application wire, in meters (m).

Recommended separation distances between portable and mobile RF communication equipment and the device.
The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter :

Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter m
---|---
150 kHz to 80 MHz Not applicable| 80 MHz to 800 MHz
d = 1.2 | 800 MHz to 2.5 GHz
d = 2.3
0.01| N/A| 0.12| 0.23
0.1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation ls affected by absorption and reflection from structures, objects, and people.

Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment- guidance
---|---|---|---
Conducted
RF
IEC 61000-4-6
Radiated RF
IEC
61000-4-3| 3Vrms At 0.15-80MHz
6Vrms At ISM & Radio Amateur Freq.
3 V/mat 80 -2700 MHz (10V/m
Home Healthcare)
AM Mo dulation And 9-28V/mat 385-6000MHz, Pulse Mode and other Modulation| Not Applicable
3 V/mat 80 -2700 MHz (10V/m
Home Healthcare)
AM Modulation And 9-28V/mat 385-6000MHz, Pulse Mode and other Modulation| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

WARRANTY

LIMITED 5-YEAR WARRANTY
HoMedics sells its products with the intent that they are free of defects in manufacture and workmanship for a period of 5 years from the date of original purchase, except as noted below. HoMedics warrants that its products will be free of defects in material and workmanship under normal use and service. This blood pressure monitor meets the simulated measurement cycles test requirement per EN1060-3, part 8.10. This warranty extends only to consumers and does not extend to Retailers.
To obtain warranty service on your HoMedics product, contact a Consumer Relations representative by telephone at 1-800-466-3342 for assistance. Please make sure to have the model number of the product available.
HoMedics does not authorize anyone, including but not limited to Retailers, the subsequent consumer purchaser of the product from a Retailer, or remote purchasers, to obligate HoMedics in any way beyond the terms set forth herein.
This warranty does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; loss of power; dropped product; malfunction or damage of an operating part from failure to provide manufacturers recommended maintenance; transportation damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of HoMedics.
This warranty is effective only if the product is purchased and operated in the country in which the product is purchased. A product that requires modifications or adoption to enable it to operate in any other country than the country for which it was designed, manufactured, approved, and/or authorized, or repair of products damaged by these modifications is not covered under this warranty.
THE WARRANTY PROVIDED HEREIN SHALL BE THE SOLE AND EXCLUSIVE WARRANTY. THERE SHALL BE NO OTHER WARRANTIES EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS OR  NY
OTHER OBLIGATION ON THE PART OF THE COMPANY WITH RESPECT TO PRODUCTS COVERED BY THIS WARRANTY. HOMEDICS SHALL HAVE NO LIABILITY FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES. IN NO EVENT SHALL THIS WARRANTY REQUIRE MORE THAN THE REPAIR OR REPLACEMENT OF ANY PART OR PARTS THAT ARE FOUND TO BE DEFECTIVE WITHIN THE EFFECTIVE PERIOD OF THE WARRANTY. NO REFUNDS WILL BE GIVEN. IF REPLACEMENT PARTS FOR DEFECTIVE MATERIALS ARE NOT AVAILABLE, HOMEDICS RESERVES THE RIGHT TO MAKE PRODUCT SUBSTITUTIONS IN LIEU OF REPAIR OR REPLACEMENT.
This warranty does not extend to the purchase of opened, used, repaired, repackaged, and/or resealed products, including but not limited to sale of such products on internet auction sites and/or sales of such products by surplus or bulk resellers. Any and all warranties or guarantees shall immediately cease and terminate as to any products or parts thereof that are repaired, replaced, altered, or modified, without the prior express and written consent of HoMedics.
This warranty provides you with specific legal rights. You may have additional rights that may vary from state to state. Because of individual state regulations, some of the above limitations and exclusions may not apply to you.

©2018 HoMedics, LLC. All rights reserved. HoMedics is a registered trademark of HoMedics, LLC.
Distributed by Homedics, LLC, 3000 N Pontiac Trail, Commerce Township, MI 48390
IB-BPWO200
P/N: 323103143 VER: 001
Printed in China

References

• American Heart Association | To be a relentless force for a world of longer, healthier lives

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