Upper Arm Blood Pressure Monitor 6000 Series Wireless Instruction Manual Original 1WMPD4004430A 1. Introduction The Equate upper arm blood pressure monitor is designed for ease of use and accuracy. This device will facilitate your daily blood pressure regimen. We recommend that you read through this manual carefully before using the device for the first time. This device is designed for use on adults, and is not intended for infants and children. This device is designed for use to operate by yourself in the home healthcare environment to measure blood pressure and pulse rate of people for diagnosis. 2. Precautions FCC Compliance Information This device complies with Part 15 of 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 operations. Precision components are used in the construction of this device. Extremes in temperature, humidity, direct sunlight, shock or dust should be avoided. Clean the device and cuff with a dry, soft cloth or a cloth dampened with water and a neutral detergent. Never use alcohol, benzene, thinner or other harsh chemicals to clean the device or cuff. Avoid tightly folding the cuff or storing the hose tightly twisted for long periods, as such treatment may shorten the life of the components. Take care to avoid accidental strangulation of babies or infants with the hose. Do not twist the air hose during measurement. This may cause injury due to continuous cuff pressure. The device and cuff are not water resistant. Prevent rain, sweat and water from soiling the device and cuff. Measurements may be distorted if the device is used close to televisions, microwave ovens, cellular telephones, X-ray or other devices with strong electrical fields. Wireless communication devices, such as home networking devices, mobile phones, cordless phones and their base stations, and walkie-talkies can affect this blood pressure monitor. Therefore, a minimum distance of 12 / 30cm should be kept from such devices. When reusing the device, confirm that the device is clean. Used equipment, parts and batteries are not treated as ordinary household waste, and must be disposed of according to the applicable local regulations. Do not modify the device. It may cause accidents or damage to the device. To measure blood pressure, the arm must be squeezed by the cuff hard enough to temporarily stop blood flow through the artery. This may cause pain, numbness or a temporary red mark to the arm. This condition will appear especially when measurement is repeated successively. Any pain, numbness, or red marks will disappear with time. Measuring blood pressure too frequently may cause harm due to blood flow interference. Check that the operation of the device does not result in prolonged impairment of blood circulation, when using the device repeatedly. Clinical testing has not been conducted on newborn infants and pregnant woman. Do not use on newborn infants or pregnant woman. If you have had a mastectomy, please consult a doctor before using the device. Do not let children use the device by themselves and do not leave the device within the reach of children, it may cause accidents or injury. There are small parts that may cause a choking hazard if swallowed by mistake by infants. Do not touch the batteries and the patient at the same time. That may result in electrical shock. Use of accessories not detailed in this manual may compromise safety. Should the battery short-circuit, it may become hot and potentially cause burns. Allow the device to adapt to the surrounding environment before use (about one hour). Do not inflate without wrapping the cuff around the upper arm. Do not apply the cuff on an arm in which another medical device is attached. The equipment may not function properly. People who have a severe circulatory deficit in the arm must consult a doctor before using the device, to avoid medical problems. Do not self-diagnose the measurement results and start treatment by yourself. Always consult your doctor for evaluation of the results and treatment. Do not apply the cuff on an arm with an unhealed wound. Do not apply the cuff on an arm receiving an intravenous drip or blood transfusion. It may cause injury. Do not use the device where flammable gases such as anesthetic gases are present. It may cause an explosion. Do not use the device in highly concentrated oxygen environments, such as a high-pressure oxygen chamber or an oxygen tent. It may cause a fire or explosion. 3. Parts Identification Proper fit range Index Artery position symbol Air Hose 4. Symbols Symbols that appear on the display Symbols Function/Meaning Recommended Action Measurement is in progress. Remain as still as possible. Appears while measurement is in progress. It blinks when the pulse is detected. I.H.B. symbol appears when an irregular heartbeat is detected. It may appear when a very slight vibration like shivering or shaking is detected. Appears when a body or arm movement is detected. Previous measurements stored in memory. Average data FULL BATTERY The battery power indicator during measurement. Use the specified batteries only. The batteries provided with the device are for testing the device performance and may have a limited life. Remove the batteries if the device is not to be used for a long time. The batteries may leak and cause a malfunction. 5.2. Connecting The Air Hose Insert the air connector plug into the air socket firmly. Air Hose Air Connector Plug Air Socket 5.3. Selecting The Correct Cuff Using the correct cuff size is important for an accurate reading. If the cuff is not the proper size, the reading may yield an incorrect blood pressure value. The arm size is printed on each cuff. The index and proper fit range, on the cuff, tell you if you are applying the correct cuff. Refer to 5.4 Applying The Arm Cuff. If the index points outside of the range, contact customer service. The arm cuff is a consumable. If it becomes worn, purchase a new one. Symbols printed on the cuff Symbols Function/Meaning LOW BATTERY The battery power is low when it blinks. Replace all batteries with new ones when the symbol blinks. User1 and User2 AM PM Time in the morning Time in the afternoon Artery Position Symbol Index Catalog number Lot number Recommended Action Set the symbol on the artery of the upper arm or in line with the ring finger on the inside of the arm. Remove the Batteries and press the START/
STOP button, and then install the batteries again. If the error still appears, contact customer service. Take another measurement. Remain still during measurement. Apply the cuff correctly, and take another measurement. The device is connecting to the Bluetooth devices. Device internal error Unstable blood pressure due to movement during measurement. The systolic and diastolic values are within 10 mmHg of each other. The pressure value did not increase during the inflation. The cuff is not applied correctly. PUL DISPLAY ERROR The pulse is not detected correctly Pairing has not been performed correctly. Remove and reinstall the batteries. Try pairing again. Pairing in progress. 5.4. Applying The Arm Cuff 1. Wrap the cuff around the upper arm, about 1 to 2 cm above the inside of the elbow, as shown. 2. Place the cuff directly against the skin, as clothing may cause a faint pulse and result in a measurement error. 3. Constriction of the upper arm, caused by rolling up a shirtsleeve, may prevent accurate readings. 4. Confirm that the index points within the proper fit range. Note: During measurement, it is normal for the cuff to feel very tight. (Do not be alarmed). Do not roll up shirtsleeve tightly Cuff 1 to 2 cm Artery position symbol Secure the fabric fastener Air hose Index and Proper fit range Symbols printed on the device case 6. Pairing with a Mobile Device Symbols Function/Meaning Standby and Turn the device on Systolic blood pressure in mmHg Diastolic blood pressure in mmHg SYS DIA PUL/min Pulse per minute Battery installation guide Direct current Type BF: Device, cuff and tubing are designed to provide special protection against electrical shocks SN Serial number Refer to instruction manual/booklet IP International protection symbol Keep dry Clock setting Clock adjustment and memory recall User selection BT Bluetooth address Used equipment, parts and batteries are not treated as ordinary household waste, and must be disposed of according to the applicable local regurations. CAUTION In the unlikely event that this monitor causes radio wave interference to a different wireless station, change the location where this monitor is used or stop use immediately. The communication distance between this monitor and the mobile device is about 10 m. This distance is reduced by the conditions in the surrounding environment, so be sure to check that the distance is short enough for a connection to be made after measurement is complete. Be sure to use in a location where visibility between the two devices that you want to connect is good. The connection distance is reduced by the structure of buildings or other obstructions. In particular, connection may be impossible when devices are used on either side of reinforced concrete. Do not use Bluetooth connection in the range of a wireless LAN or other wireless devices, near devices that emit radio waves such as microwaves, in locations where there are many obstructions, or in other locations where signal strength is weak. Doing so may result in frequent loss of connection, very slow communication speeds and errors. In this case, switch off the power supply to the device that is not being used or use the monitor in a different location. If the monitor does not connect normally when used near a wireless station or broadcast station, use the monitor in a different location. Walmart cannot accept liability for any damages incurred due to impaired operation or data loss, etc that occur through the use of this product. This product is not guaranteed to connect to all Bluetooth compatible devices. 6.1 Bluetooth Transmission Bluetooth devices carry the Bluetooth logo mark. To connect with your mobile device download and install Equate Heart Chart app. Follow the instructions in the app to connect. 6.2 Cautions for Pairing Only one device can be paired with this monitor at one time. If the mobile device cannot receive measurement data, try pairing again. The monitor is capable of registering 4 mobile devices. In case a 5th mobile device is registered, the monitor will delete the oldest mobile device. 6.3 Pairing Procedure 1. Turn on Bluetooth settings on your mobile device 2. Press and hold the START/STOP button until Pr is displayed, and then release the button. The monitor will be in a state that can be found by the mobile device for about one minute. Blinking 3. If E 10 is displayed or pairing is failed, remove the batteries and try steps 1-3 again. 4. Accept the pairing request on the Equate Heart Chart app. 6.4 Transmitting Temporarily Stored Data In cases when the mobile device cannot receive measurement data, the measurement data is temporarily stored in the monitor memory. The data stored in the memory is transmitted the next time a connection is successfully made to the mobile device. A total of 90 sets of measurement data can be stored per user. When the amount of data exceeds 90, the oldest data is deleted and the new data is stored. 6.5 Time This monitor has a built-in clock. The date and time that a measurement was taken is included in the measurement data. The built-in clock is automatically adjusted by syncing the clock of a mobile device. Sync of the time is done in the timing Bluetooth icon lights up, in the pairing process. 7. Measurements 7.1. Normal Measurement 1. Place the cuff on the arm at heart level (preferably the left arm). Sit quietly during measurement. button. 2. Press the Select a user from user and user . 3. Press the START/STOP button. All of the display segments are displayed. Zero is displayed blinking briefly. Then the display changes, as indicated in the figure at the right, as the measurement begins. The cuff starts to inflate. It is normal for the cuff to feel very tight. A pressure bar indicator is displayed, as in the figure at the right, during inflation. Note: If you wish to stop in-
flation at any time, press the START/STOP button again. 4. When inflation is complete, deflation starts automatically and the blinks, indicating that the measurement is in progress. Once the pulse is detected, the symbol blinks with each pulse beat. Note: If an appropriate pressure is not obtained, the device starts to inflate again automatically. 5. When the measurement is complete, the systolic and diastolic pressure readings and pulse rate are displayed. The cuff exhausts the remaining air and deflates completely. In case the monitor is connected to a mobile device, its possible to transfer the measurement data to the app, when the measurement is done. At heart level Press the button Press the START/STOP button All of the display segments Zero display Starts inflation Pressurizing Measurement in progress Systolic pressure Diastolic pressure AHA classification Pulse rate Exhausts remaining air automatically BLE mark blinks when communicating
(transferring the data) Turn off and store data with the START/STOP button 6. Press the START/STOP button again to turn off the power and the measurement data is stored. Note: This device has an automatic power shut-off function. Allow at least 3 minutes between measurements on the same person. 7.2. Measurement with the Desired Systolic Pressure If re-inflation occurs repeatedly, or if your systolic pressure is expected to exceed 230 mmHg, use this procedure. 1. Place the cuff on the arm at heart level (preferably the left arm). 2. Press the START/STOP button. 3. While the zero blinks, press and hold the START/STOP button until a number about 30 to 40 mmHg higher than your expected systolic pressure appears. 4. When the desired number is reached, release the START/STOP button to start measurement. Then continue to measure your blood pressure as described on the section 7.1 Normal Measurement. At heart level Press the START/STOP button Press and hold the START/STOP button Inflation in progress Release the START/STOP button to stop inflation The desired pressure Refer to the section 7.1 Normal Measurement 7.3. Notes for Accurate Measurement Sit comfortably on a chair with your feet on the floor and your back straight. Do not cross your legs. Place your arm on a table with your palm facing upward and the cuff at the same level as your heart. Relax for about five to ten minutes before measurement. Remain still and keep quiet during measurement. Do not smoke, exercise, or consume anything for at least 30 minutes beforehand. This device bases its measurements on the heartbeat. If you have a very weak or irregular heartbeat, the device may have difficulty determining your blood pressure. Should the device detect a condition that is abnormal, it will stop the measurement and display an error symbol. Refer to the section 4 Symbols for the description of the symbols. Try to measure your blood pressure at the same time every day. The automatic blood pressure monitors performance may be affected by excessive temperature or humidity, or altitude. Display 5. Using the Monitor Arm Cuff START/STOP Button User Selection Button Clock Button Button Air Socket Air Connector Plug Battery Compartment Battery Cover 5.1. Installing / Changing The Batteries 1. Remove the battery cover. 2. Remove the used batteries from the battery compartment to change them. 3. Insert new batteries into the battery compartment as shown, taking care that the polarities (+) and (-) are correct. Use only R6P, LR6 or AA batteries. 4. Replace the battery cover. Step 4 Step 1 1.5V Batteries
(LR6, R6P or AA) Step 2 Step 3 Display AHA Classification Indicator Bluetooth Connection Symbol I.H.B. Symbol Movement Error Symbol Pressure Bar Indicator Heart Symbol Users MEMORY Symbol Average Symbol Systolic Pressure Diastolic Pressure Pulse Rate Date and Clock AM/PM Symbol Battery Indicator CAUTION Insert the batteries as shown in the battery compartment. If installed incorrectly, the device will not work. When blinks on the display, replace all batteries with new ones. Do not mix old and new batteries. It may shorten the battery life, or cause the device to malfunction. Replace the batteries two seconds or more after the device turns off. does not appear when the batteries are drained. The battery life varies with the ambient temperature and may be shorter at low temperatures. Generally, four new R6P batteries will last approximately three months when used twice for measurement each day. 8. Recalling the Memory Data 14. Troubleshooting Recommended Action Replace all batteries with new ones. Reinstall the batteries with negative and positive terminals matching those indicated on the battery compartment. 17. Technical Data Type Measurement method Oscillometric measurement Measurement range Pressure:
UA-6000BLEWM 0 - 299 mmHg 60 - 279 mmHg 40 - 200 mmHg 40 - 180 beats/minute 3 mmHg 5 %
Systolic pressure:
Diastolic pressure:
Pulse:
Pressure:
Pulse:
Measurement accuracy Power Supply Replace all batteries with new ones. Number of measurements Approx. 700 LR6 or AA (alkaline batteries) Approx. 200 R6P (manganese batteries) With pressure value 180 mmHg, room temperature 23 C. 4 x 1.5V batteries (R6P, LR6 or AA) Problem Nothing appears on the display, even when the power is turned on. The cuff does not inflate. Possible Reason Batteries are drained. Battery terminals are not in the correct position. Battery voltage is too low. blinks. If the batteries are drained completely, the symbol does not appear. The cuff is not applied properly. You moved your arm or body during measurement. Apply the cuff correctly. Make sure you remain still and quiet during measurement. The device does not measure. Readings are too high or too low. The cuff position is not correct. Sit comfortably and still. Place your arm on a table with your palm facing upward and the cuff at the same level as your heart. If you have a very weak or irregular heartbeat, the device may have difficulty in determining your blood pressure. At a clinic or doctors office, apprehension may cause an elevated reading. Home measurement reduces the effects of outside influences on blood pressure readings
& supplements the doctors readings. Remove the batteries. Place them back properly and take 1 another measurement. Note: If the actions described above do not solve the problem, contact customer service. Do not attempt to open or repair this product, as any attempt to do so will make your warranty invalid. The value is different from that measured at a clinic or doctors office. Other 15. Maintenance Do not open the device. It uses delicate electrical components and an intricate air unit that could be damaged. If you cannot fix the problem using the troubleshooting instructions, contact customer service. 16. Satisfaction Guaranteed Classification Clinical test Internally powered ME equipment (by batteries) Continuous operation mode According to ISO81060-2:2013 In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. EMD IEC 60601-1-2: 2014 Wireless Communication Bluetooth:
Ver.5.1LE BLP Frequency band:
2402 MHz to 2480 MHz Maximum RF output power: < 10 dBm Modulation:
GFSK Supported Data:
Systolic Pressure, Diastolic Pressure, Pulse Rate Communication distance:
About 10 m (This distance is reduced by the conditions in the surrounding environment) Paired device:
4 devices Memory 90 measurements per user Operating conditions
+10 to +40 C/15 to 85 %RH/800 to 1060 hPa Transport/Storage conditions
- 20 to +60 C/10 to 95 %RH/700 to 1060 hPa Cuff Circumference UA-420WM: 8.6-16.5 (22 to 42 cm) Dimensions Weight Ingress protection Applied part Useful life Approx. 4.33[W]2.80[H]5.47[D] (110[W]71[H]139[D] mm) Approx. 10.58oz (300g), excluding the batteries Device: IP20 Cuff: Type BF Device: 5 years (when used six times a day) Cuff: 2 years (when used six times a day) Note: Specifications are subject to change without prior notice. IP classification is the degrees of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12 mm diameter and greater such as a finger. This device is not protected against water FCC Caution Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Satisfaction guaranteed Or well replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. This equipment has very low levels of RF energy that it deemed to comply without maximum permissive exposure evaluation (MPE). It is recommended that this equipment be installed and operated keeping the radiator at least 20 cm or more away fro the users body (excluding extremities: hands, writs, feet and ankles). Walmart Inc. 702 S.W. 8th St. Bentonville, AR 72716 www.walmart.com 1-888-287-1915 Equate wordmark and logos are trademarks of Walmart Apollo LLC. The Bluetooth word mark and logos are registered trademarks of Bluetooth SIG, Inc. Note: This equipment has been tested and found to comply with the limits for 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. It 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. EMD Technical Data Battery-operated Blood Pressure Monitor Medical Electrical Equipment needs special precautions regarding EMD and needs to be installed and put into service according to the EMD information provided in the following. Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the unit. Table 1 - EMISSION Limits Conducted and radiated RF EMISSION CISPR 11 Group 1, Class B Phenomenon Compliance Table 2 - IMMUNITY TEST LEVELS : Enclosure Port Phenomenon Electrostatic discharge IEC 61000-4-2 Radiated RF EM fields IEC 61000-4-3 Proximity fields from RF wireless communications equipment IEC 61000-4-3 Rated power frequency magnetic fields IEC 61000-4-8 IMMUNITY TEST LEVELS 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 10 V/m 80 MHz - 2.7 GHz 80 % AM at 1 kHz See table 3 30 A/m 50 Hz or 60 Hz Table 3 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency
(MHz) Band
(MHz) Service Modulation Maximum power (W) Distance (m) IMMUNITY TEST LEVEL
(V/m) 385 450 710 745 780 810 870 930 1720 1845 1970 380 - 390 TETRA 400 430 - 470 GMRS 460 FRS 460 704 - 787 LTE Band 13, 17 800 - 960 1700 - 1990 GSM 800/900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1, 3, 4, 25 UMTS Bluetooth WLAN 802.11 b/g/n RFID 2450 LTE Band 7 Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 1.8 2 0.2 2 2 2 2450 2400 - 2570 5240 5500 5785 5100 - 5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 0.3 0.3 0.3 0.3 0.3 0.3 27 28 9 28 28 28 9 The device automatically stores up to 90 x 2 blood pressure and pulse measurements in memory. Data stored in memory are assigned a data number in the order of the newest to the oldest. The oldest data displays as in the upper left corner of the display indicates that you are viewing previous data stored in memory. symbol
. The Press the button Average systolic Average diastolic Average pulse Average of the last 3 data Most recent data Systolic Diastolic Pulse Systolic Diastolic Pulse Last data (oldest) Return to average of the last 3 data 8.1. Recalling Data 1. Press the button. 2. Select the user you want to review the memory for by pressing Select a user from user or user . the button. 3. Press the button. The average of the last three measurements is displayed.
(If no data, 0 is displayed. Press the or START/
STOP button to turn device off.) 4. Each time the button is pressed, the memory data is displayed as follows. Most recent data (ex. no. 35). Three seconds after the data number displays, the measurement data is displayed. Last data (ex. no.1). Three seconds after the data number displays, the measurement data is displayed. 5. After the last data is User memory data User average data displayed, press the button to return the average display of the last three measurements. 6. Press the START/STOP button to turn the device off. After one minute of non-operation the device will turn off automatically. 7. Each time the button is pressed, the user is changed and the average of the last three measurements for that user is displayed. Note: If this device stores the two measurements, the average of the two measurements is displayed. If this device stores only one measurement, this is displayed. 8.2. Clearing Data 1. Press button to move to the memory display mode. 2. Select the user you want to delete with user button. 3. Turn off the power pressing START/STOP button. 4. Press and hold button. 5. Memory icon blinks and the data is deleted. 6. The device power will be turned off automatically. 9. Setting Date and Time Set the date and time prior to use. 1. Press the 2. Select the year using the button button, the year starts blinking. button. Press the to set the current year and move to month / day selection. The date can be set anywhere between the years 2021 and 2059. 3. Select the month using the button. Press the button to set the current month and move to day selection. 4. Select the day using the button. Press the button to set the current day and move to hour / minute selection. Press Year Month Day Hour 5. Select the hour using the button. Press the button to set the current hour and move to minute selection. 6. Select the minute using the button. Press the button to turn the device off. Minute Pressing the START/STOP button will turn the device off anytime. Turn off Note: After three minutes of non-operation, the device will turn off automatically. When the clock has not been set, the clock display indicates dashes as shown to the right. When using the device for the first time, the clock is not adjusted. When the device is disconnected from the power supply, the set date and time will be erased. When the set date and time is erased, please adjust again. The clock of the monitor can sync to the clock of the mobile device during Bluetooth communication.
10. What is an Irregular Heartbeat The blood pressure monitor provides a blood pressure and pulse rate measurement even when an irregular heartbeat occurs. An irregular heartbeat is defined as a heartbeat that varies from the average of all heartbeats during the blood pressure measurement. It is important that you are relaxed, remain still and do not talk during measurements. Note: We recommend contacting your physician if you see this indicator frequently. 11. Pressure Bar Indicator The indicator monitors the progress of pressure during measurement. Pressurizing Releasing air Measurement in progress Inflation complete Inflation in progress 12. About Blood Pressure What is Blood Pressure?
Blood pressure is the force exerted by blood against the walls of the arteries. Systolic pressure occurs when the heart contracts. Diastolic pressure occurs when the heart expands. Blood pressure is measured in millimeters of mercury (mmHg). Ones natural blood pressure is represented by the fundamental pressure, which is measured first thing in the morning while one is still at rest and before eating. 13. AHA Classification Indicator Each segment of the bar indicator corresponds to the AHA blood pressure classification. AHA Classification Indicator
The indicator displays a segment, based on the current data, corresponding to the AHA classification. Stage 2 Hypertension Stage 1 Hypertension Elevated Normal