Omron HeartGuide BO8000-L, Instruction Manual

Page 1: ...Model BP8000 L Instruction Manual 2872436 0B ...

Page 2: ...ing the Battery 19 2 2 Installing the Cuff Sleeve 21 2 3 Wearing the Monitor on the Left Wrist 21 2 4 Turn Your Monitor On 23 3 Using Your Monitor without a Smart Device 24 3 1 Taking a Blood Pressure Measurement 25 4 Using Your Monitor with a Smart Device 32 4 1 Pairing Your Monitor with a Smart Device 32 4 2 Taking a Blood Pressure Measurement 33 4 3 Taking Activity Measurements 34 4 4 Taking Sl...

Page 3: ...r to the Default Settings 51 7 4 Turning Off Your Monitor 52 8 Error Messages and Troubleshooting 53 8 1 Error Messages 53 8 2 Troubleshooting 57 9 Maintenance 59 9 1 Maintenance 59 9 2 How to Replace the Cuff Sleeve 59 9 3 Storage 60 9 4 Cleaning 60 9 5 Disposal 61 10 Optional Accessories 62 11 Specifications 63 12 FCC Statement 68 13 Limited Warranty 69 14 Guidance and Manufacturer s Declaration...

Page 4: ...sor displays a digital reading of blood pressure This monitor can also track measurements such as steps calories burned hours slept and awake time Safety Instructions This instruction manual provides you with important information about the OMRON BP8000 L Wrist Blood Pressure Monitor To ensure the safe and proper use of your monitor READ and UNDERSTAND all of the safety and operating instructions ...

Page 5: ... 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 1 800 634 4350 Symbols Glossary For symbol information visit OmronHealthcare com symbols glossary Contraindications Blood Pressure Measurement Usage The monitor is contraindicated for...

Page 6: ... 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 wear this monitor 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 compu...

Page 7: ...ng cable away from infants toddlers or children This product contains small parts that may cause a choking hazard if swallowed by infants toddlers or children 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 when in RF restri...

Page 8: ...O NOT use it in any other devices DO NOT recharge the rechargeable battery once it has been removed from this monitor DO NOT dispose of the battery in a fire DO NOT crush or puncture the battery because it may cause spontaneous flames DO NOT disassemble or modify the battery DO NOT connect the and poles using a piece of metal or other conductive objects DO NOT carry it or store it together with it...

Page 9: ...n irritation or discomfort DO NOT use this device if you have a metal allergy Keep this monitor clean If this monitor is causing skin irritation due to sweat or contamination stop using it and consult with your dermatologist Prolonged rubbing and pressure may irritate the skin Give your wrist a break by removing the monitor for a while after extended wear DO NOT let chemical products such as lotio...

Page 10: ...cessary because bruising due to blood flow interference may occur ONLY inflate the cuff when the band is applied to your wrist Remove the band if it does not start deflating during a blood pressure measurement During measurement make sure that no mobile device or any other electrical device that emits electromagnetic fields is within 12 inches 30 cm of this monitor This may result in incorrect ope...

Page 11: ...vironments 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 blood pressure measurement Rest for at least 5 minutes befor...

Page 12: ...formation of operating and storage transport temperature refer to section 11 DO NOT use this monitor after the durable period has ended Refer to section 11 DO NOT crease the band excessively DO NOT use the blood pressure measuring function for any other purpose DO NOT use this monitor to diagnose sleep disorders Consult with your physician or healthcare provider if you begin a weight reduction or ...

Page 13: ...nch it DO NOT place it under heavy objects Wipe any dust off of the AC adapter Unplug the AC adapter when not in use Unplug the AC adapter before cleaning this monitor ONLY use the AC adapter and charging cable specified for this monitor Use of unsupported AC adapters or cables may damage and or may be hazardous to this monitor Rechargeable Battery Handling and Usage DO NOT charge the battery when...

Page 14: ...g clip Model HEM CLIP 01 AC adapter Model HHP AM02 Charging cable Model HHX CB07U Replacement cuff sleeve Model HEM CUCV 01L 2 pcs Instruction manual Quick start guide Paper sizing guide 1 Know Your Monitor 1 1 Contents ...

Page 15: ...14 a Display b START STOP button c FORWARD button d HOME button Press this button from any screen to go back to HOME screen e Band f Charging port g Cuff 1 2 Monitor 1 Know Your Monitor a b c d e g f ...

Page 16: ...symbol Appears when your data needs to be transferred because the stored memory is either almost or completely full Once you pair your monitor with your smart device transfer your readings immediately before the monitor deletes the oldest reading Refer to page 17 for each internal memory F Bluetooth OFF symbol Appears when Bluetooth is disabled Disconnect symbol Appears when your monitor is not co...

Page 17: ...irregular rhythm is detected 2 or more times during a blood pressure measurement An irregular heartbeat rhythm is defined as a rhythm that is 25 less or 25 more than the average rhythm detected while your monitor is measuring the blood pressure The irregular heartbeat symbol may be displayed when the monitor detects arm movements Refer to section 8 to solve the problem If it continues to appear we...

Page 18: ...ngs in its internal memory as follows Blood pressure measurements Up to 100 readings Activity data Up to 7 days Sleep data Up to 7 times Event data Up to 100 items Battery Symbols Indicates current battery remaining Remaining Low Full Symbols Depleted 1 Know Your Monitor ...

Page 19: ...mHg or 80 89 mmHg Stage 2 140 mmHg or 90 mmHg Hypertensive crisis 180 mmHg and or 120 mmHg Individuals with Systolic BP and Diastolic BP in 2 categories should be designated to the higher BP category BP indicates blood pressure based on an average of 2 careful readings obtained on 2 occasions Source ACC AHA 2017 High Blood Pressure Clinical Practice Guideline Warning NEVER diagnose or treat yourse...

Page 20: ...n if the electrode terminal of the charging clip touches a metal object such as the body of the monitor or the buckle FOLLOW the steps below when charging the battery 1 Plug the smaller end of the charging cable into the charging clip 2 Lift the band and connect the clip to the charging port of your monitor Make sure the cuff sleeve does not cover the charging port Charging clip Charging port Band...

Page 21: ... recharge it Do not charge the battery in environments where there is high heat or cold temperatures Charging Status Remaining Low Full Symbols FULL Battery Life Your monitor will last up to 2 days per charge depending on use and storage condition Refer to Battery Life Information page 65 for the terms of the battery life Note The battery life will eventually get shorter due to recharging the moni...

Page 22: ...Cover the cuff by pulling the cuff sleeve toward the charging port Charging port 3 Cover the charging port 2 3 Wearing the Monitor on the Left Wrist Blood pressure can differ between the right and left wrists and readings can be different OMRON recommends always using the same wrist when measuring blood pressure Consult with your physician to determine which wrist you should use for your measureme...

Page 23: ...e a snug fit prior to measuring not too tight not too loose Your index finger should NOT easily slide between the band and your wrist 2 5 3 c m 1 i n c h Make sure that the cuff is positioned correctly When the upper and lower sides of the cuff are overlapped the lower side should be positioned under the upper side Refer to the illustration Correct Not correct Upper side Lower side Wearing the Mon...

Page 24: ...e app for pairing Note You can use your monitor without pairing to your smart device Refer to section 3 page 24 To take activity measurements and sleep measurements pair your monitor with your smart device Refer to sub section 4 1 page 32 If the monitor does not turn on or the screen below appears on the display charge the battery Refer to sub section 2 1 page 19 2 Preparation ...

Page 25: ...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 blood pressure measurement Note When using your monitor without a smart device you can take only blood pressure measurements When using your monitor without a smart device you will not be able to view your prior re...

Page 26: ...n 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 Caution Avoid bathing drinking alcohol or caffeine smoking exercising and eating for at least 30 minutes befo...

Page 27: ...d is important 1 Find the positioning mark on the band Positioning mark 2 Position the positioning mark on the center of your wrist align with your middle finger The positioning mark may be covered by the buckle depending on your wrist size Positioning mark 3 Using Your Monitor without a Smart Device ...

Page 28: ...our feet flat and your legs uncrossed Relax your wrist and hand Do not bend your wrist back clench your fist or bend your wrist forward 3 1 4 Taking a Blood Pressure Measurement Note To stop the measurement press the START STOP button once to deflate the cuff 1 Press the START STOP button The heart zone indicator will appear Connect to the Smart device app for pairing Place the monitor over your h...

Page 29: ...conds the monitor will start a measurement and the cuff will start to inflate 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 2 inches space Note DO NOT make the band and your body touch while taking a measurement After approximately 5 seconds your monitor will start a ...

Page 30: ...ssure 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 sub section 1 4 the number and indicator will be shown in red 67 mmHg Place the monitor over your heart SYS mmHg DIA mmHg PULSE min 78 70 5 17 AM 118 8 38 Note To stop a measurement press any button Wait 2 3 minutes between measureme...

Page 31: ... If it does not vibrate your monitor may not be at the correct height and position relative to your heart Due to differences in individual size and physique this feature may not be helpful in all cases and you may wish to turn off this feature If you feel the position of the wrist according to the heart zone indicator s guidance does NOT match your heart level please turn off this feature and foll...

Page 32: ...vel Your body moved during measurement Do not move and take another measurement Irregular heartbeats are detected Irregular heartbeat Warning DO NOT adjust medication based on your readings from this blood pressure monitor Take medication only as prescribed by your physician ONLY a physician is qualified to diagnose and treat high blood pressure NEVER diagnose or treat yourself based on your readi...

Page 33: ...include the date and time when you transfer If you do not pair the monitor any measurements you take will not include the date and time Review the list of compatible smart devices at OmronHealthcare com 1 Enable Bluetooth on your smart device 2 Scan the code below with your smart phone camera or visit OmronHealthcare com app to find the OMRON compatible app for this product 3 Download then open th...

Page 34: ...er service Refer to section 13 page 69 Error Note Only compatible OMRON apps should be used with this monitor to help ensure correct data transfer Be aware that OMRON will not be responsible for the loss of data and or information in the app If you change your smart device that was paired with your monitor delete the pairing information from your old smart device to avoid communication issue 4 2 T...

Page 35: ...and follow the instructions Note Make sure your monitor is within 16 ft 5 m of your smart device When the Bluetooth OFF symbol appears on the display of your monitor enable Bluetooth Refer to sub section 7 2 page 49 When the sync symbol appears on the display the stored memory is almost full Transfer the data immediately before your readings are deleted Once you transfer your readings to the app y...

Page 36: ...onal information you are asked to provide on the app is to help calculate measurements accurately You can also set your daily target steps on the app 2 Set your stride length The initial stride length displayed on the app is an estimated value calculated by your height setting You may choose to adjust your stride length by adding the new value in the app For instructions on calculating your stride...

Page 37: ...START END 3 Wear your monitor wherever you go When your target steps are achieved the achievement screen appears 5000 steps Congratulations 4 Press the FORWARD button to view the readings stored in the memory Refer to section 6 page 43 for more information Blood pressure Activities Sleep 10217 5 1mile 328kcal SYS mmHg DIA mmHg PULSE min 78 70 5 17 AM 118 THU 17 8 38 8 38 7h26 80 5 17 5 18 8h12 Dat...

Page 38: ...en not walking Carrying a bag Extremely slow arm movements Doing housework without walking Walking at an Inconsistent Pace Shuffling or wearing sandals Constantly starting and stopping walking or moving at some other inconsistent pace Walking extremely slowly Moving Up and Down Standing up and sitting down Playing sports other than walking Going up or down stairs or a steep slope Vibrations from a...

Page 39: ...ls in section 6 page 45 for more information Note Only wear your monitor on your wrist During the sleep mode your monitor does not count your steps If you set the sleep mode manually you cannot take a blood pressure measurement or change settings 1 Pair your monitor with your smart device Before taking a measurement pair your monitor with your smart device Refer to sub section 4 1 page 32 You can ...

Page 40: ...to start the sleep measurement Sleep mode Sleep mode ON 3 Get up Your monitor will detect rising and disable the sleep mode automatically Note If the Auto sleep function is disabled press and hold the START STOP button to stop the sleep measurement Your monitor may not track your sleep data in the following instances Wearing your monitor somewhere other than your wrist Wearing your monitor too loo...

Page 41: ...from Brian Message Mail from mail omron com Email Note Refer to the app for compatible email apps or any other information Your monitor cannot receive a notification from your smart device during the following When taking a blood pressure measurement When the Bluetooth function of your monitor or smart device is disabled Only English alphabets and digits can be displayed correctly on your monitor ...

Page 42: ...reminder can only be set on the app 11 30AM 11 30AM 11 30AM Note To stop the vibration press any button If the reminder time comes while taking a blood pressure measurement the alert will start after the measurement The reminder will not alert you when the monitor is being charged or the battery is depleted 4 Using Your Monitor with a Smart Device ...

Page 43: ...you ate took a medicine exercised or had another event Note The recorded time of your events can be viewed on the app only An event cannot be recorded during transferring the data to the app 1 Press and hold the FORWARD button for more than 3 seconds THU 17 8 38 2 Record appears on the display Record ...

Page 44: ... the FORWARD button THU 17 8 38 2 Press the FORWARD button one by one The display of your readings changes as below For activities and sleep the ring around the reading describes the level of achievement against your target Blood pressure Activities Sleep 10217 5 1mile 328kcal SYS mmHg DIA mmHg PULSE min 78 70 5 17 AM 118 THU 17 8 38 8 38 7h26 80 5 17 5 18 8h12 Date time ...

Page 45: ... 118 8 38 Alternating pulse symbols display Symbol Meaning This monitor is not at the correct height Irregular heartbeats are detected Movement during measuring Meaning of each display item Activities Sleep 10217 5 1mile 328kcal 7h26 80 5 17 5 18 8h12 Total steps Distance Calories burned Sleep period time Percent achieved Target sleep period time 6 Viewing the Readings Stored in Memory ...

Page 46: ...hat helps us stay healthy Aerobic steps are counted separately when walking more than 60 steps per minute and more than 10 minutes successively If a rest of less than 1 minute is taken after a continuous walk of more than 10 minutes this will be regarded as part of a continuous walk Note Aerobic steps can be viewed on the app only Sleep period time Indicates your actual time asleep Awake time Indi...

Page 47: ...ep time Wake up time Time until you fall asleep Sleep period time Time of movement at restless level 2 during sleep period time Sleep mode enabled Sleep mode disabled 0 1 2 Total amount of sleep period time is from when the time sleep mode is enabled to the time sleep mode is disabled except the awake time ...

Page 48: ...on for more than 3 seconds ON OFF L R THU 17 8 38 7 1 1 Enabling Disabling Heart Zone Indicator 1 Press the START STOP button for heart zone indicator setting ON OFF L R 2 Press the START STOP button to enable or press the HOME button to disable Note The heart zone indicator is enabled by default The current setting is shown in the bracket ON OFF ...

Page 49: ...OME button for wrist setting ON OFF L R 2 Press the START STOP button if you wear your monitor on the left wrist or press the HOME button if you wear the monitor on the right wrist Note Left is set by default Current setting is indicated in the bracket L R 7 Settings ...

Page 50: ... Entering Pairing Mode Press and hold the HOME button for more than 3 seconds Refer to sub section 4 1 page 32 to pair your monitor with your smart device Note Bluetooth will be enabled automatically after pairing with your smart device successfully THU 17 8 38 Connect to the Smart device app for pairing 7 Settings ...

Page 51: ...ose areas For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC Press and hold the HOME button for at least 3 seconds when your monitor is in the pairing mode When Bluetooth is enabled this operation will make it disabled When Bluetooth is disabled this operation will make it enabled Note Bluetooth is enabled by default Connect to the Smart devi...

Page 52: ...t 7 seconds When the confirmation screen appears press the START STOP button to restore your monitor ClearAll Cancel Cleared THU 17 8 38 Note Reverting to its default setting of your monitor does not delete the information in the app You will need to re pair your monitor when using the monitor again Without repairing your readings will not be transferred to your app Refer to sub section 4 1 page 3...

Page 53: ...tor will not delete your reading or any information in the monitor and the app however your step numbers from the past hour may be lost After restarting open the app The date and time will be set automatically When using your monitor without a smart device you can only take blood pressure measurements When using your monitor without a smart device you will not be able to view your prior readings t...

Page 54: ... Remove your monitor Wait for 2 3 minutes and then take another measurement Repeat the steps in sub section 3 1 page 25 If this error continues to appear we recommend that you consult with your physician Do not move and take another measurement Your body moved during a measurement Carefully read and repeat the steps in sub section 3 1 page 25 Position device at heart level Your monitor is not at t...

Page 55: ...king the app contact customer service Refer to section 13 page 69 Please see the manual Error 1 The band is not applied correctly Apply the band correctly then take another measurement Refer to sub section 2 3 page 21 Air is leaking from the cuff Contact customer service Refer to section 13 page 69 Clothing is interfering with the band Remove any clothing interfering with the band Refer to sub sec...

Page 56: ...onitor while taking a measurement Please see the manual Error 4 You move or talk during a measurement Vibrations disrupt a measurement Remain still and do not talk during a measurement Please see the manual Error 5 The band was not applied correctly or was moved during a measurement Apply the band correctly then take another measurement Refer to sub section 2 3 page 21 Remain still and sit correct...

Page 57: ...emperature If the error appears again contact customer service Refer to section 13 page 69 The monitor has malfunctioned Please see the manual Error 9 The band may be applied too tightly Apply the band correctly then take another measurement Refer to sub section 2 3 page 21 Error Room temperature is too high to charge the battery Charge the battery at a moderate room temperature The monitor has ma...

Page 58: ...ngs appear too high or too low Blood pressure varies constantly Many factors including stress time of day and or how you apply the band may affect your blood pressure Review sub section 3 1 page 25 Any other communication issue occurs Follow the instructions shown in the smart device or visit the Help section in the app for further help If the problem still persists contact customer service Refer ...

Page 59: ...ely and contact customer service Refer to section 13 page 69 The operating time is short or the monitor does not operate even when the battery is fully charged This may be due to the life of the rechargeable battery The battery cannot be replaced Contact customer service refer to section 13 page 69 or dispose of your monitor Refer to sub section 9 5 page 61 8 Error Messages and Troubleshooting ...

Page 60: ...r will void the user warranty Caution DO NOT disassemble or attempt to repair this monitor or other components 9 2 How to Replace the Cuff Sleeve Clean the cuff sleeve when it becomes dirty once a week cleaning is recommended Replace the cuff sleeve to new one in half a year 1 Detach the cuff sleeve 2 Refer to sub section 2 2 page 21 to install the cuff sleeve ...

Page 61: ...soft dry cloth or a soft cloth moistened with neutral soap to clean your monitor and then wipe them with a dry cloth Do not wash or immerse your monitor in water Do not use gasoline thinners or similar solvents to clean your monitor Do not use a wet cloth on the plugs of the AC adapter The charging cable or the terminal of the charging clip Hand wash with mild detergent and air dry the cuff sleeve...

Page 62: ...monitor for a while after extended wear Be careful not to let chemical products such as lotions oils skin creams or cosmetics collect on the band If this happens wipe them immediately otherwise it may impact the material and lifetime of product 9 5 Disposal Dispose of your monitor and other components according to applicable local regulations Unlawful disposal may cause environmental pollution 9 M...

Page 63: ...arging clip Model HEM CLIP 01 AC adapter Model HHP AM02 Charging cable Model HHX CB07U Cuff sleeve Model HEM CUCV 01L For further information visit our website at OmronHealthcare com 10 Optional Accessories ...

Page 64: ...ss communication Frequency range 2 4 GHz 2400 2483 5 MHz Modulation GFSK Effective radiated power 20 dBm Operation mode Continuous operation IP classification Monitor IP22 AC adapter IPX0 Rating DC 3 8 V 3 0 W Power source 1 Lithium ion polymer rechargeable battery 3 8 V Approximately 164 mAh AC adapter INPUT AC100 240 V 50 60 Hz 0 2 0 13 A Battery lifespan Will last for approximately 500 cycles 8...

Page 65: ... to 35 C Storage conditions 4 to 104 F 20 to 40 C 10 to 90 RH non condensing Transport conditions 4 to 140 F 20 to 60 C 10 to 90 RH non condensing Weight Approximately 4 2 oz 120 g Dimensions Case diameter Approximately 1 89 48 mm Case thickness Approximately 0 55 14 mm Band width Approximately 1 18 30 mm Measurable wrist circumference 7 1 to 8 5 180 to 215 mm Contents Monitor charging clip HEM CL...

Page 66: ...ng per day 8 hour sleep measurement per day 96 times of button pressing per day 16 times of incoming call per day 1 time of ringing alarm per day 16 hour Bluetooth communication per day The battery life depends on the terms of use and the environment of storage Blood pressure measurement Cuff pressure range 0 to 299 mmHg Blood pressure measurement range SYS 60 to 230 mmHg DIA 40 to 160 mmHg Pulse ...

Page 67: ...the clinical validation study K5 was used on 85 subjects for determination of diastolic blood pressure This monitor is comply with the requirements of ISO 81060 2 2013 This monitor has not been validated for use on pregnant patients IP classification is degrees of protection provided by enclosures in accordance with IEC 60529 This monitor is protected against ingress of dust which would cause issu...

Page 68: ...rate 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 Pictogram on the Product Indicates the correct positioning for the band on the wrist Indicates the correct positioning for the monitor on the wrist 11 S...

Page 69: ...e 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 relocat...

Page 70: ...ginal 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 WARRANT...

Page 71: ... OMRON HEALTHCARE Co Ltd conforms to IEC60601 1 2 2014 Electromagnetic Compatibility EMC standard Further documentation in accordance with this EMC standard is available at OmronHealthcare com emc Refer to the EMC information for BP8000 L on the website 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 und...

Page 72: ...ALTHCARE 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 OmronHealthcare com 2021 OMRON HEALTHCARE INC Made in Japan ...