® INSTRUCTION MANUAL 7 Series Wrist Blood Pressure Monitor ENGLISH Model BP6350
Table of Contents Introduction ..................................................................................................3 Important Safety Information ........................................................................5 1. Know Your Monitor ................................................................................9 2. Preparation ..........................................................................................15 3. Using Your Monitor without a Smart Device ......................
Introduction Thank you for purchasing the OMRON BP6350 Wrist Blood Pressure Monitor. This blood pressure monitor is to be worn on your wrist. This monitor can be used by multiple users. This new blood pressure monitor uses the oscillometric method of blood pressure measurement. When the cuff inflates, this monitor senses the pressure pulsations of the artery underneath the cuff. The pulses are called oscillometric pulses. The electronic pressure sensor displays a digital reading of blood pressure.
Contraindications • This monitor is contraindicated for use in ambulatory environments. • This monitor is contraindicated for use on aircraft.
Important Safety Information Please read the Important Safety Information in this instruction manual before using this monitor. Please follow this instruction manual thoroughly for your safety. Please keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN. Indicates a potentially hazardous situation which, if not Warning avoided, could result in death or serious injury.
Data Transmission • This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in this monitor and remove batteries when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/IC. Battery Handling and Usage • Keep batteries out of the reach of infants, toddlers or children.
• DO NOT use this monitor in a moving vehicle such as in a car. • DO NOT drop or subject this monitor to strong shocks or vibrations. • DO NOT use this monitor in places with high or low humidity or high or low temperatures. Refer to chapter 9. • During measurement, observe the arm to ensure that the monitor is not causing prolonged impairment to blood circulation. • DO NOT use this monitor in high-use environments such as medical clinics or physician offices.
Battery Handling and Usage • DO NOT insert batteries with their polarities incorrectly aligned. • ONLY use 2 “AAA” alkaline batteries with this monitor. DO NOT use other types of batteries. DO NOT use new and used batteries together. DO NOT use different brands of batteries together. • Remove batteries if this monitor will not be used for a long period of time. • If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician immediately.
1. Know Your Monitor 1.1 Contents Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual, quick start guide 1.2 Monitor c a d b e f g a. Wrist cuff (Wrist circumference 5.3" to 8.5" (13.5 cm to 21.5 cm)) b. Display c. [Memory] button d. [Date/Time setting] button e. [START/STOP] button f. [Connection] button g.
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A Date and time display Average value symbol B C Appears when viewing the average readings of the latest 2 or 3 readings taken within 10 minutes span. Memory symbol Appears when viewing readings stored in the memory. D Systolic blood pressure reading E Diastolic blood pressure reading Pulse display / Memory number F G H Pulse rate appears after the measurement. When pressing the button, the memory number appears for approximately one second before the pulse rate appears on the display.
High symbol K Appears if your systolic blood pressure is 130 mmHg or above and/or the diastolic blood pressure is 80 mmHg or above. Refer to section 1.4 for more information. Heart zone indicator Your monitor has a built-in heart zone indicator that is used as an aid in determining if the monitor is at the correct height. L The “ ” symbol lights in blue when your monitor is at the correct position relative to your heart during a measurement.
Battery symbol (low) P Flashes when batteries are low. Battery symbol (depleted) Appears when batteries are depleted. Bluetooth ON symbol Q Appears when Bluetooth is enabled. Bluetooth OFF symbol Appears when Bluetooth is disabled.
1.4 Classification of BP (Blood Pressure) ACC/AHA 2017 Hypertension guidelines define categories of BP in adults as below. Categories of BP in Adults* BP Category Normal Systolic BP < 120 mmHg Elevated Diastolic BP and < 80 mmHg 120 - 129 mmHg and < 80 mmHg Hypertension Stage 1 Stage 2 130 - 139 mmHg or 80 - 89 mmHg ≥ 140 mmHg or ≥ 90 mmHg * Individuals with Systolic BP and Diastolic BP in 2 categories should be designated to the higher BP category.
2. Preparation 2.1 Installing Batteries 1. Push down the hook of the battery cover and pull downward. 2. Insert 2 “AAA” alkaline batteries as indicated in the battery compartment. 3. Close the battery cover. 2 1 Note • When the “ ” symbol flashes on the display, it is recommended you replace batteries. • To replace batteries, turn your monitor off and remove all batteries. Then replace with 2 new alkaline batteries at the same time.
2.2 Setting the Date and Time Note • Set your monitor to the correct date and time before taking a measurement for the first time. • As soon as batteries are correctly installed, the year flashes on the display of your monitor. • The date and time will automatically be set when the monitor is paired with “OMRON connect US/CAN” app. Refer to section 4.1. 1. 2. Press the or button once to adjust the year. Press and hold the button to quickly advance the years.
3. Press the [START/STOP] button to store the setting. It automatically turns off after 3 seconds. Note • If you need to reset the date and time, replace batteries or press and hold the button until the year flashes, and set the date and time as above steps. 2.3 Blood Pressure Measurement Tips To help ensure an accurate reading, follow these directions: • Stress raises blood pressure. Avoid taking measurements during stressful times. • Measurements should be taken in a quiet place.
2.4 Applying the Wrist Cuff Note • Following steps are for applying the wrist cuff to your left wrist. When you take a measurement on your right wrist, apply the wrist cuff using the same steps as on your left wrist. • The blood pressure can differ between the right wrist and the left wrist, and the measured blood pressure values can be different. OMRON recommends to always use the same wrist for measurement.
3. Position the wrist cuff leaving a clearance of 0.5 inch (1 to 2 cm) between the cuff and the bottom of your palm. 0.5 inch (1 to 2cm) 4. Wrap the wrist cuff firmly around your wrist. Do not apply over clothing. Check to make sure that there is no gap between your wrist and the cuff. 1 2 Note • Make sure the wrist cuff does not cover the protruding part of the wrist bone on the outside of your wrist.
2.5 Sitting Correctly To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. Place your elbow on the table to support your arm. • Sit in a chair with your legs uncrossed and your feet flat on the floor. • Sit with your back and arm being supported. • The distance from the top of your seat measuring to the top of the table you are sitting at, should be 12 plus or minus 2 inches (30 ± 5 cm).
3. Using Your Monitor without a Smart Device 3.1 Taking a Measurement You can use your monitor without pairing to a smart device. To pair your monitor with a smart device, refer to section 4.1. Note • To stop the measurement, press the [START/STOP] button once to deflate the wrist cuff. Caution • DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
Monitor height Heart Zone Indicator Wrist is too high Any locator bar (-) above the “ appears. Proper position The “ Wrist is too low Any locator bar (-) below the “ appears. ” symbol ” symbol lights in blue. Note ” symbol • After 5 seconds from pressing the [START/STOP] button, even if your monitor is not positioned properly, your monitor will start the measurement and the wrist cuff will start to inflate.
3. Remain still and do not move or talk until the entire measurement process is completed. As the cuff inflates, your monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation. The “ ” symbol flashes at every heartbeat. Note • When the “ ” symbol is displayed, the wrist cuff is not applied correctly. Press the [START/STOP] button to turn your monitor off, then apply the cuff correctly.
4. Using Your Monitor with a Smart Device 4.1 Pairing Your Monitor with a Smart Device The date and time on your monitor will automatically be set when you pair your monitor with your smart device. Review the list of compatible smart devices at OmronHealthcare.com. 1. Enable Bluetooth on your smart device. 2. Download and install the free “OMRON connect US/CAN” app onto your smart device.
4. Confirm that your monitor is connected successfully. When your monitor is connected successfully to your smart device, the “OK” symbol flashes. Note • If the “Err” symbol appears, follow the instructions in the “OMRON connect US/CAN” app • Your monitor automatically turns off after 10 seconds without any operations. • Any readings currently saved in the memory of your monitor are automatically transferred to the app after successful completion of the pairing process.
4.3 Disabling/Enabling Bluetooth Warning • This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in this monitor and remove batteries when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/IC. Bluetooth is enabled as default. 1.
5. Using Memory Function Your monitor automatically stores up to 90 readings. Note • This monitor can be used by multiple users. When you use memory function with other users, track (or manage) your own readings appropriately. 5.1 1. Viewing the Readings Stored in Memory Press the button. Alternating date/time display The Memory number appears for one second before the pulse rate is displayed. The most recent reading set is numbered “1”.
5.2 Viewing the Average Reading Your monitor can calculate an average reading based on the latest 2 or 3 readings taken within 10 minutes span. 1. When your monitor is off, press and hold the 2 seconds. Note • If there are only 2 readings in the memory for that period, the average will be based on these 2 readings. • If the average reading is high (refer to section 1.3), the “ ” symbol appears.
6. Other Settings 6.1 Disabling/Enabling Heart Zone Indicator The heart zone indicator is enabled as default. 1. When your monitor is off, press and hold the 10 seconds. button for more than Note • Your monitor will automatically turn off after 3 seconds from the completion. • To enable the heart zone indicator, follow the same steps as above. 6.2 Deleting All Readings Stored in Memory 1. Press the 2. While holding the button down, press and hold the [START/STOP] button for more than 2 seconds.
6.3 Restoring Your Monitor to the Default Settings To delete all the information stored in your monitor, follow the instructions below. Make sure that your monitor is turned off. 1. While holding the button down, press the [START/STOP] button within 2 seconds. Hold both buttons for more than 5 seconds. Note • Reverting to its default setting of your monitor does not delete the information in the app. • Your monitor will automatically turn off after 3 seconds.
7. Error Messages and Troubleshooting In case of any of the below problems occur during measurement, first check that no other electrical device is within 12 inches (30 cm). If the problem persists, please refer to the table below. Display/Problem Possible Cause The wrist cuff is not applied correctly. appears or the wrist cuff does not Air is leaking from the wrist inflate. cuff. appears appears Apply the wrist cuff correctly, then take another measurement. Refer to section 2.4.
Display/Problem appears Possible Cause Your wrist is moved up and down during a measurement. Do not move your wrist, then take another measurement. Refer to chapter 3. The monitor is malfunctioned. Press the [START/STOP] button again. If “Er” still appears, contact customer service. Refer to chapter 11. appears appears flashes flashes Solution Follow the instructions shown in the “OMRON connect US/ The monitor cannot connect to CAN” app.
Display/Problem Possible Cause Solution More than 70 readings are not transferred. flashes appears This monitor is ready for pairing or transferring your readings. 90 readings are not transferred. heart symbol The heart zone indicator is The heart symbol disabled. in the heart zone indicator does not light and a locator bar does not appear. flashes Pair or transfer your readings to the “OMRON connect US/ CAN” app so you can keep them in memory in the app, and this error symbol disappears.
Display/Problem Possible Cause appears or the monitor is turned Batteries are depleted. off unexpectedly during a measurement No power. Nothing appears on the display of the monitor. Solution Immediately replace all batteries with 2 new alkaline batteries. Refer to section 2.1. Batteries are completely depleted. Battery polarities are not properly aligned. Check the battery installation for proper placement. Refer to section 2.1. Blood pressure varies constantly.
8. Maintenance 8.1 Maintenance To protect your monitor from damage, please follow the directions below: • Changes or modifications not approved by the manufacturer will void the user warranty. Caution • DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading. 8.2 Storage Keep your monitor in the storage case when not in use. • Store your monitor in a clean, safe location. Do not store your monitor: • If your monitor is wet.
9. Specifications Model BP6350 Display LCD digital display HEM-6231T-Z Cuff pressure range 0 to 299 mmHg Blood pressure measurement range SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg Pulse measurement range 40 to 180 beats / min. Accuracy Pressure: ±3 mmHg Pulse: ±5% of display reading Inflation Automatic by electric pump Deflation Automatic rapid deflation Measurement method Oscillometric method Transmission method Bluetooth® low energy technology Wireless communication Frequency range: 2.
Dimensions Approximately 3.6" (w) × 2.5" (h) × 0.5" (l)* (91 mm × 63 mm × 13 mm) (not including the wrist cuff) Measurable wrist circumference 5.3" to 8.5" (13.5 to 21.5 cm) Memory Stores up to 90 readings Contents Monitor, storage case, 2 “AAA” alkaline batteries, instruction manual, quick start guide Protection against electric shock Internally powered ME equipment Applied part Type BF (wrist cuff) Maximum temperature of the applied part Lower than +118.
Pictogram on the Product Indicates the correct positioning for the monitor on the wrist. About a wireless communication interference This product operates in an unlicensed ISM band at 2.4 GHz. In the event this Product is used near other wireless devices such as microwave and wireless LAN, which operate on the same frequency band as this Product, there is a possibility that interference may occur.
10. FCC Statement FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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.
11. Limited Warranty Your BP6350 Wrist Blood Pressure Monitor, excluding batteries, is warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The above warranty extends only to the original retail purchaser. We will, at our option, replace without charge any monitor covered by the above warranty.
This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you. FOR CUSTOMER SERVICE Visit our web site at: OmronHealthcare.
12. Guidance and Manufacturer’s Declaration OMRON Battery-operated Blood Pressure Monitor Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electro Magnetic Compatibility (EMC) BP6350 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/ emc.
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other trademarks and trade names are those of their respective owners. App Store is a service mark of Apple Inc., registered in the U.S and other countries. Google Play and the Google Play logo are trademarks of Google LLC. OMRON HEALTHCARE Co., Ltd 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN Distributed by: OMRON HEALTHCARE, INC.
