OMRON HEALTHCARE HEM6232T Blood Pressure Monitor User Manual
OMRON HEALTHCARE Co.,Ltd Blood Pressure Monitor
05 Short-Term Confidential_User Manual
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. Wrist Blood Pressure Monitor 1.1 Contents Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual, quick start guide 1.2 The “ ” symbol lights in blue when your monitor is at the correct position relative to your heart during a measurement. When your monitor is higher or lower position relative to your heart, the heart position locator bar will appear up above, or below the heart symbol to guide correct wrist positioning. Monitor • Keep batteries out of the reach of infants, toddlers or children. Table of Contents Introduction Important Safety Information 1. Know Your Monitor 2. Preparation 3. Using Your Monitor without a Smart Device 4. Using Your Monitor with a Smart Device 5. Using Memory Function 6. Other Settings 7. Error Messages and Troubleshooting 8. Maintenance 9. Specifications 10. FCC/IC Statement 11. Limited Warranty 12. Guidance and Manufacturer’s Declaration Introduction Thank you for purchasing the OMRON BP4350 Wrist Blood Pressure Monitor. This blood pressure monitor is to be worn on your wrist. 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. Safety Instructions This instruction manual provides you with important information about the OMRON BP4350 Wrist Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5.3 inches to 8.5 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. Environments of Use: Home Patient Population: Adult Receiving and Inspection Remove this monitor from the packaging and inspect for damage. If this monitor is damaged, DO NOT USE and contact 1-800-6344350. Symbols Glossary For symbol information, visit: OmronHealthcare.com/symbols-glossary 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 avoided, could result in death or serious injury. • DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves. • DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure. • DO NOT use this monitor on an injured wrist or a wrist under medical treatment. • DO NOT apply the wrist cuff on your wrist while on an intravenous drip or blood transfusion. • DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners or in oxygen rich environments. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. • Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading. • NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician. • This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children. Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the equipment or other property. • Stop using this monitor and consult with your physician if you experience skin irritation or discomfort. • Consult with your physician before using this monitor on a wrist where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury. • Consult with your physician before using this monitor if you have had a mastectomy. • Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising. • DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may occur. • ONLY inflate the wrist cuff when it is applied on your wrist. • Remove the wrist cuff if it does not start deflating during a measurement. • DO NOT use this monitor for any purpose other than measuring blood pressure. • During measurement, make sure that no mobile device or any other electrical device that emit electromagnetic fields is within 12 inches (30 cm) of this monitor. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. • DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading. • DO NOT use in a location where there is moisture or a risk of water splashing this monitor. This may damage this monitor. • 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. • Ensure this monitor is not impairing blood circulation by observing the wrist while measurement is occurring. • DO NOT use this monitor in high-use environments such as medical clinics or physician offices. • 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. • Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for at least 30 minutes before taking a measurement. • Rest for at least 5 minutes before taking a measurement. • Remove tight-fitting, thick clothing and any accessories from your wrist while taking a measurement. • Remain still and DO NOT talk while taking a measurement. • ONLY use this monitor on persons whose wrist circumference is within the specified range of the cuff. • Ensure that the monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. • DO NOT crease the wrist cuff excessively. Data Transmission • DO NOT replace batteries while your reading is being transferred to your smart device. This may result in the incorrect operation of this monitor and failure to transfer your blood pressure data. 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. • 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. • If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury or pain persists, consult with your physician. • DO NOT use batteries after their expiration date. • Periodically check batteries to ensure they are in good working condition. • ONLY use batteries specified for this monitor. Use of unsupported batteries may damage and/or may be hazardous to this monitor. button to quickly go backwards 2. Press the [START/STOP] button to confirm the year and the month will flash. Repeat the same steps to adjust the month, day, hour, and minute. Irregular heartbeat symbol 2829250-8A Press and hold down the through the years. Heart zone indicator Battery Handling and Usage Model BP4350 Instruction Manual Warning 1. Know Your Monitor a. Wrist cuff (Wrist circumference 5.3" to 8.5" (13.5 cm to 21.5 cm)) b. Display c. Battery compartment d. [User ID selection] switch e. [Memory] button f. [Morning average] button g. [START/STOP] button h. [Connection] button 1.3 Year Normal Heartbeat Appears along with Pulse readings when an irregular rhythm is Blood pressure detected 2 or more times during a measurement. Irregular Heartbeat Short Long An irregular heartbeat Pulse rhythm is defined as a Blood pressure rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring the systolic and diastolic blood pressure. If it continues to appear, we recommend you to consult with and follow the directions of your physician. Movement error symbol Appears along with readings when your body is moving during a measurement. If it appears, remove the wrist cuff, and wait for 2 to 3 minutes. Then, remain still and take another measurement. Cuff wrap guide symbol Appears if the wrist cuff is not wrapped around the wrist correctly while taking a measurement. It also appears when viewing past readings. Display Battery symbol (low) Appears when batteries are low. Battery symbol (depleted) Bluetooth ON symbol Appears when Bluetooth is enabled. Bluetooth OFF symbol 2013 ESH/ESC* Guidelines for the management of arterial hypertension Definitions of hypertension by office and home blood pressure levels 1.4 Display Symbols A Date and time display Average value symbol 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 Flashes when your data needs to be transferred because the stored memory is either almost, or completely full. Once you pair your monitor with a smart device, transfer your readings immediately before your monitor deletes the oldest readings. Up to 100 readings can be stored in the internal memory per user. Flashes when your monitor is connected to the smart device or readings are transferred successfully. Appears when viewing the weekly average readings taken in the morning. Weekly averages for the measurement taken in the morning within 4 weeks appear on the display. The user ID number appears when selecting the user with [User ID selection] switch. Hypertension symbol 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 the button until the year flashes, and set the date and time as above steps. 2.3 The “ ” symbol appears if your systolic blood pressure is 135 mmHg or above and/or the diastolic blood pressure is 85 mmHg or above. Morning hypertension symbol The “ ” symbol appears when the morning weekly average is 135/85 mmHg or above. • 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). If the distance measured between the top of your seat and table do not fall within this parameter, correct your seat or table height. If you are unable to make any seat or table adjustments, please turn off the heart zone indicator and position your wrist at heart level by yourself. Refer to section 6.1. • Your monitor must be approximately the same level as your heart. If the monitor is too high above your heart, your blood pressure will be artificially low. If the monitor is too low below your heart, your blood pressure will be artificially high. • Relax your wrist and hand. Do not bend your wrist back, clench your fist, or bend your wrist forward. 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. • It is important to take measurements at same times each day. Taking measurements in the morning and in the evening is recommended. • Remember to have a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. 2.6 Selecting a User ID Your monitor is designed to take measurements and store the readings in the memory for 2 people using the [user ID selection] switch. 1. Select your user ID (1 or 2). ≥ 135 mmHg Diastolic Blood Pressure ≥ 90 mmHg ≥ 85 mmHg Applying the Wrist Cuff Note • Following steps are for applying the wrist cuff to your left wrist. When you take a measurement on the right wrist, apply the wrist cuff using the same steps as on the 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. If the values between both wrists differ substantially, please check with your physician as to which wrist to use for your measurements. Caution • Remove tight-fitting, thick clothing and any accessories from your wrist while taking a measurement. 1. Apply the wrist cuff to your left Roll up sleeve. Make sure your sleeve is not rolled up too tightly on your arm. This may constrict the flow of blood in your arm. 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. • Remain still and DO NOT talk while taking a measurement. 2. Check the 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. It has been designed to work with most people so that when your battery cover and pull downward. Wrist cuff 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. as indicated in the battery compartment. 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. All symbols appear on the display before starting the measurement. Your palm and monitor display should both face upward. 2. Insert 2 “AAA” alkaline batteries 3.1 1. Press the [START/STOP] button. 2. Put your wrist through the cuff loop. Installing Batteries 3. Using Your Monitor without a Smart Device wrist. wrist is at the correct position relative to your heart, the “ ” symbol will light in blue. When your wrist is higher or lower position relative to your heart, a locator bar will appear according to the wrist position. Due to difference in individual size and physique, this feature may not be helpful in all cases and you may wish to disable this feature. If you feel the position of the wrist according to heart zone indicator's guidance does NOT match your heart level, disable this feature and follow your judgement. To disable it, refer to section 6.1. 0.5 inch (1 to 2cm) Flashes while taking a measurement. User ID symbol Minute Heartbeat symbol Morning average symbol ≥ 140 mmHg 1. Push down the hook of the Flashes during cuff deflation. OK symbol Systolic Blood Pressure 2. Preparation Deflation symbol Sync symbol Home Warning • NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician. Pulse display / Memory number Pulse rate appears after the measurement. F When pressing the button, the memory number appears for approximately one second before the pulse rate appears on the display. Office These are from statistical values for blood pressure. * European Society of Hypertension (ESH) and European Society of Cardiology (ESC). 2.1 Hour 2.4 Appears when Bluetooth is disabled. Day 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. Caution • Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for at least 30 minutes before taking a measurement. • Rest for at least 5 minutes before taking a measurement. Appears when batteries are depleted. Month 2.5 3. Close the battery cover. 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. Note • When the “ ” symbol appears 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. • As soon as batteries are correctly installed, the year flashes on the date and time display to set the date and time. • Replacing batteries will not delete previous readings. • The supplied batteries may have a shorter life than new batteries. • Disposal of used batteries should be carried out in accordance with local regulations. 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. Press the or Press and hold down the years. button once to adjust the year. button to quickly advance the Monitor height Wrist is too high Note • Make sure your wrist cuff does not cover the protruding part of the wrist bone on the outside of your wrist. • If the wrist cuff comes out of the metal ring, slide it back through as shown in the figure to the right. Proper position Wrist is too low Note Heart Zone Indicator Any locator bar (-) above the “ The “ ” symbol appears. ” symbol lights in blue. Any locator bar (-) below the “ ” symbol appears. • 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. • When the Bluetooth is disabled, the following symbol appears. 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 “ 6. Other Settings 6.1 1. Select your user ID. Note INFLATING • Your monitor will automatically turn off after 3 seconds from the completion. • To enable the heart zone indicator, follow the same steps as above. 5. Using Memory Function Viewing the Readings Stored in Memory 2. Press the 6.2 Alternating date/time display COMPLETED 2. Press the The Memory number appears for one second before the pulse rate is displayed. The most recent reading set is numbered “1”. • If the heart zone indicator is enabled before the measurement, the heart zone indicator is displayed with the readings. • If the reading is high (refer to section 1.4), the “ ” symbol appears. • If there are no readings stored in the memory, the screen to the right is displayed. • If the memory is full, the monitor will delete the oldest readings. 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. CAN” app onto your smart device. 3. Press the button repeatedly to scroll through the previous readings stored in the memory. 5.2 If you already have the “OMRON connect US/CAN” app and have created your account, open the app and add your new monitor. 3. Open the app on your smart device. Press the [ button (found on the back of your monitor) for more than 2 seconds to start pairing. Then follow the instructions. 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. Select your User ID. 2. When your monitor is off, press and hold the for more than 2 seconds. • 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 section1.4), the “ ” symbol appears. • Make sure that your monitor is turned off. If it is on, press the [START/STOP] button to clear the LCD screen. 4. Confirm that your monitor is connected successfully. 5.3 • If the “Err” symbol appears, follow the message of the app. • Your monitor automatically turns off after 10 seconds without any operations. • Your monitor can store 2 user's readings, however the app can only store 1 user's readings. Each user will need his/her own OMRON connect account to transfer their readings. • Any readings currently saved in the memory of your monitor are automatically transferred to the app after successful completion of the pairing process. • Please be aware that OMRON will not be responsible for the loss of data and/or information in the app. • Read the utilization method and usage instruction within the app for details. 4.2 Taking a Measurement Refer to section 3.1 to start a measurement. The readings will be transferred to your smart device. button once. The morning weekly average for the current week “THIS WEEK” appears on the display. If the morning weekly average is high (refer to section 1.4), the “ appears. Restoring Your Monitor to the Default Settings 3. Continue to press the for the previous weeks. 1. While holding the 4. Press the [START/STOP] button to turn off your monitor. Morning Weekly Average Calculation This is the average for the measurements taken during the morning (4:00am - 9:59am) between Sunday and Saturday. Only the first 3 measurements taken in the morning between 4:00am - 9:59am will be used to calculate the morning average for each day. Disabling/Enabling Bluetooth Sunday 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. • You will need to re-pair your monitor when using the monitor again. Without re-pairing, your readings will not be transferred to your app. Monday Tuesday Possible Cause The wrist cuff is not applied correctly. appears or the wrist cuff does Air is leaking from the not inflate. wrist cuff. Wednesday Thursday Bluetooth is enabled as default. Contact customer service. Refer to chapter 11. appears appears You move or talk during a measurement. Vibrations disrupt a measurement. Remain still and do not talk during a measurement. Refer to chapter 3. appears appears The pulse rate is not detected correctly. The first 3 measurements appears Disposal Dispose of your monitor and other components according to applicable local regulations. Unlawful disposal may cause environmental pollution. 9. Specifications Model Display Cuff pressure range Blood pressure measurement range Pulse measurement range Batteries are low. appears or the monitor is Batteries are depleted. turned off unexpectedly during a measurement Enable the “heart zone indicator”. Refer to section 6.1. Immediately replace all batteries with 2 new alkaline batteries. Refer to section 2.1. Batteries are completely depleted. No power. Nothing Check the battery appears on the Battery polarities are not installation for proper display of the properly aligned. placement. Refer to monitor. section 2.1. Blood pressure varies constantly. Many factors Readings including stress, time of day, and/or how you appear too high apply the wrist cuff, may affect your blood or too low. pressure. Review sections 2.3 - 2.5 and chapter 3. Any other Follow the instructions shown in the smart device. communication If the problem still persists, contact customer issue occurs. service. Refer to chapter 11. Any other problems occurs. Press the [START/STOP] button to turn the monitor off, then press it again to take a measurement. If the problem continues, remove all batteries and wait for 30 seconds. Then reinstall batteries. If the problem still persists, contact customer service. Refer to chapter 11. 8. Maintenance 8.1 Inflation Deflation Measurement method Transmission method Bluetooth® low energy technology IP classification Rating Power source Battery life Note • These specifications are subject to change without notice. • In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. • This monitor is clinically investigated according to the requirements of ISO 81060-2:2013. • IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger, and against oblique falling water drops which may cause issues during a normal operation. Storage Keep your monitor and other components in the storage case when not in use. • Store your monitor and other components in a clean, safe location. Do not store your monitor and other components: • If your monitor and other components are wet. • In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach. • In locations exposed to vibrations or shocks. This equipment complies with FCC/IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS 102 of the IC radio frequency (RF) Exposure rules. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption ratio (SAR). 11. Limited Warranty Your BP4350 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. Replacement is our only responsibility and your only remedy under the above warranty. To obtain warranty service contact Customer Service by calling 1800-634-4350 for the address of the inspection center and the return shipping and handling fee. Enclose the original printed receipt. Include a letter, with your name, address, phone number, and description of the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, we recommend insuring the product with return receipt requested. THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES. 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: For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca Call toll free: 1-800-634-4350 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) BP4350 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. Refer to the EMC information for BP4350 on the website. 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. If interference occurs, stop the operation of the other devices or relocate this Product away from other wireless devices before attempting to use it. The Bluetooth® word mark and logos are registered trademarks owned by 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. 10. FCC/IC Statement The monitor is malfunctioned. 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. Note The monior cannot connect to a smart device or transmit data correctly. Follow the instructions shown in the “OMRON connect US/CAN” app. If the “Err” symbol still appears after checking the app, contact customer service. Refer to chapter 11. • “oFF” appears on the display. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Indicates the correct positioning for the monitor on the wrist. Press the [START/ STOP] button again. If “Er” still appears, contact customer service. Refer to chapter 11. button for more than 10 seconds. 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. Pictogram on the Product To protect your monitor from damage, please follow the directions below: • Changes or modifications not approved by the manufacturer will void the user warranty. 8.2 Frequency range: 2.4 GHz (2400 2483.5 MHz) Modulation: GFSK Effective radiated power: <20 dBm IP 22 DC3 V 3.0 W 2 “AAA” alkaline batteries 1.5V Approximately 300 measurements (using new alkaline batteries) Durable period (Service 5 years life) +50°F to +104°F (+10°C to +40°C) / 15 to Operating conditions 90% RH (non-condensing) / 800 to 1060 hPa Storage / Transport -4°F to +140°F (-20°C to +60°C) / 10 to conditions 90% RH (non-condensing) Approximately 3.2 oz. (90 g) not Weight including batteries Approximately 3.6” (w) × 2.5” (h) × 0.5” (l) Dimensions (91.0 mm × 63.4 mm × 13.4 mm) (not including the wrist cuff) Measurable wrist 5.3” to 8.5” (13.5 to 21.5 cm) circumference Memory Stores up to 100 readings per user Monitor, storage case, 2 “AAA” alkaline Contents batteries, instruction manual, quick start guide Protection against Internally powered ME equipment electric shock Applied part Type BF (wrist cuff) Maintenance Caution • DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading. 40 to 180 beats / min. Pressure: ±3 mmHg Pulse: ±5% of display reading Automatic by electric pump Automatic rapid deflation Oscillometric method Wireless communication Replacing all batteries with 2 new alkaline batteries is recommended. Refer to section 2.1. BP4350 HEM-6232T-Z LCD digital display 0 to 299 mmHg SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg Your wrist is moved up and down during a measurement. 1. When your monitor is off, press and hold onto the [ ] appears 8.4 Do not move your wrist, then take another measurement. Refer to chapter 3. 9:59 appears Apply the wrist cuff correctly, then take another measurement. Refer to section 2.4. Remain still and sit correctly during a measurement. Refer to section 2.5. If the “ ” symbol continues to appear, we recommend you to consult with your physician. Saturday Apply the wrist cuff correctly, then take another measurement. Refer to section 2.4. Do not touch the wrist cuff while taking a measurement. appears Friday Solution The wrist cuff is overinflated exceeding 300 mmHg. 4:00 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. flashes button down, press and hold the [START/STOP] button for more than 5 seconds. button to display the average Your monitor displays “-1 WEEK” for the previous week's average, to “-3 WEEK” for the oldest set of averages. The “heart zone The heart indicator” is disabled. symbol in the heart zone indicator does not light and a locator bar does not appear. To delete all the information stored in your monitor, follow the instructions below. Make sure that your monitor is turned off. ” symbol Measurements of the morning 4.3 6.3 Viewing Morning Weekly Averages 2. Press the Note • All readings will be deleted. You cannot partially delete the readings stored in the memory. Display/ Problem 1. Select your User ID. Pair or transfer your This monitor is ready for readings to the “OMRON connect US/ pairing or transferring CAN” app so you can your readings. keep them in memory in the app, and this error 100 readings are not symbol disappears. transferred. heart symbol 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. Your monitor calculates and displays weekly averages for the measurements taken in the morning for 4 weeks per user. Flashes when transferring your The [ ] button is pressed to transfer your readings to the “OMRON connect US/ readings. CAN” app. Cleaning • Do not use any abrasive or volatile cleaners. • Use a soft dry cloth or a soft cloth moistened with neutral soap to clean your monitor and wrist cuff, and then wipe them with a dry cloth. • Do not wash or immerse your monitor and wrist cuff or other components in water. • Do not use gasoline, thinners or similar solvents to clean your monitor and wrist cuff or other components. Accuracy 7. Error Messages and Troubleshooting Note Note When your monitor is connected successfully to your smart device, the “OK” symbol flashes. button appears ” symbol appears. Note Note Pairing Your Monitor with a Smart Device 2. Download and install the free “OMRON connect US/ button, then the “ The [ ] button is Appears when pairing pressed and held to pair to the smart device. with a smart device. 3. While holding the Note 4. Using Your Monitor with a Smart Device flashes Deleting All Readings Stored in Memory button down, press and hold the [START/ STOP] button for more than 2 seconds. • Your monitor will automatically turn off after 2 minutes. • Wait 2-3 minutes between measurements. The wait time allows the arteries to decompress and return to their premeasurement form. You may need to increase the wait time depending on your individual physiological characteristics. Solution More than 80 readings are not transferred. 1. Select your user ID. button. 4. Press the [START/STOP] button to turn your monitor off. 4.1 flashes Note Your monitor automatically stores up to 100 readings per user. 1. Select your User ID. START off, press and hold the button for more than 10 seconds. • To enable the Bluetooth, press and hold on the [ ] button for more than 2 seconds. “on” appears on the display. • Your monitor will automatically turn off within 3 seconds after the completion. 5.1 flashes 2. When your monitor is 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. 8.3 Possible Cause Disabling/Enabling Heart Zone Indicator The heart zone indicator is enabled as default. ” symbol flashes at every heartbeat. After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed. If either the Systolic or the Diastolic reading is high (refer to section 1.4), the “ ” symbol appears. Display/ Problem 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 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 Apple, the Apple logo, iPad and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S and other countries. iOS is a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license. Android and the Google Play logo are trademarks of Google Inc. Manufactured for: OMRON HEALTHCARE Co., Ltd 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN Distributed by: OMRON HEALTHCARE, INC. 1925 West Field Court Lake Forest, IL 60045 U.S.A. For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca © 2018 OMRON HEALTHCARE, INC. Made in Vietnam
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