FCC ID: Q6ZMHEM7145T2 Blood Pressure Monitor

3293795-5A Blood Pressure Monitor Model BP9300T Instruction Manual Table of Contents Introduction Important Safety Information 1. Know Your Monitor 2. Preparation 3. Using Your Monitor without a Telehealth Service Receiver 4. Using Your Monitor with a Telehealth Service Receiver 5. Using Memory Function 6. Other Settings 7. Error Messages and Troubleshooting 8. Maintenance 9. Optional Accessories 10. Specifications 11. FCC/ISED Statement 12. Limited Warranty 13. Guidance and Manufacturers Declaration Introduction Thank you for purchasing the OMRON BP9300T Blood Pressure Monitor. This monitor can be used by multiple users. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. Safety Instructions This instruction manual provides you with important information about the OMRON BP9300T Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact your Telehealth service provider or contact OMRON at 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with readings. Environments of Use: Home Patient Population: Adult Receiving and Inspection Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and contact your Telehealth service provider or contact OMRON at 1-800-634-4350. 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 Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN. Warning 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 arm or an arm under medical treatment. DO NOT apply the arm cuff on your arm 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. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. DO NOT use this monitor in oxygen rich environments or near flammable gas. 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. To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children. This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and 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, remove batteries and/or unplug the AC adapter when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/ISED. AC Adapter (optional accessory) Handling and Usage DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately. Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug. NEVER plug in or unplug the AC adapter from the electric outlet with wet hands. DO NOT disassemble or attempt to repair the AC adapter. Battery Handling and Usage Keep batteries out of the reach of infants, toddlers and 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 an arm where intravascular access or therapy, or an arterio-venous (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 arm cuff when it is applied on your upper arm. Remove the arm 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 emits 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 section 10. 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. DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the devices 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 or thick clothing from your arm while taking a measurement. Remain still and DO NOT talk while taking a measurement. ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff. Ensure that this monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature. For additional information on operating and storage/transport temperature, refer to section 10. DO NOT use this monitor after the durable period has ended. Refer to section 10. DO NOT crease the arm cuff or the air tube excessively. DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood flow. To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor. ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings. Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. NOTE: refer to If your systolic pressure is more than 210 mmHg in section 3 of this instruction manual for additional information. Data Transmission DO NOT replace batteries or unplug the AC adapter while your readings are being transferred to the Telehealth service receiver. This may result in incorrect operation of this monitor and failure to transfer your blood pressure data. AC Adapter (optional accessory) Handling and Usage Fully insert the AC adapter into the outlet. When unplugging the AC adapter from the outlet, be sure to safely pull from the AC adapter. DO NOT pull from the AC adapter cable. When handling the AC adapter cable:

DO NOT damage it. DO NOT break it. DO NOT tamper with it. DO NOT forcibly bend or pull it. DO NOT twist it. DO NOT use it if it is gathered in a bundle. DO NOT pinch 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. Battery Handling and Usage DO NOT insert batteries with their polarities incorrectly aligned. ONLY use 4 AA alkaline or manganese 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. 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. 1. Know Your Monitor 1.1 Contents/Product Includes Monitor, Wide-Range D-Ring Cuff, 4 AA batteries, instruction manual, quick start guide 1.2 Monitor and Arm Cuff Front of the monitor a b c Display

[Connection] button

(Memory)

[START/STOP] button Left side, back and bottom of the monitor Air jack AC adapter jack

(for optional AC adapter) Battery compartment d e f g h Air plug Air tube Arm cuff

(Upper arm circumference: 9" - 17" (22 - 42 cm)) 1.3 Display and Symbols a b A B C D E F c d e f g h G H I J K L M OK symbol Flashes when your monitor is connected to the Telehealth service receiver successfully. Bluetooth ON symbol Appears when your readings are being transferred. Bluetooth OFF symbol Appears when Bluetooth is disabled. Systolic blood pressure reading Diastolic blood pressure reading Heartbeat symbol Flashes while taking a measurement. Deflation symbol Appears during cuff deflation. Sync symbol Flashes: the stored memory is almost full Appears: the stored memory is completely full Once you pair your monitor with the receiver, transfer your readings immediately before the monitor deletes the oldest reading. Up to 30 readings can be stored in the internal memory of your monitor. Memory symbol Appears when viewing readings stored in the memory. High symbol Appears if your systolic blood pressure is 130 mmHg or the diastolic blood pressure is 80 mmHg. Refer to sub-

section 1.5 for more information. Movement error symbol Appears with your reading when your body is moving during a measurement. If it appears, remove the arm cuff and wait for 2 to 3 minutes. Then, reapply the cuff, remain still and take another measurement. Irregular heartbeat symbol Appears when irregular rhythm is detected 2 or more times during a 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 blood pressure. Short Long Irregular Heartbeat Normal Heartbeat Irregular heartbeat symbol may be displayed when the monitor detects arm movements. Refer to section 7 for more information. If it continues to appear, we recommend you to consult with and follow the directions of your physician. Low battery symbol Flashes when batteries are low. Depleted battery symbol Appears when batteries are depleted. Pulse display / Memory number Pulse rate appears after the measurement. A B C D E F G H I J K L M 1.4 Wireless Function Before use, thoroughly read the instruction manual included with the Telehealth service receiver (in some cases, receiver may be your smart device) being used with this blood pressure monitor, for instructions about your monitor connecting to the Telehealth service receiver, and receiver transmission range. It will be necessary for the blood pressure monitor to be within the receivers transmission range to successfully transfer data. This OMRON blood pressure monitor is designed to connect to specific Bluetooth receivers, and is not guaranteed to connect to all Bluetooth compatible devices and Telehealth service receivers. OMRON Healthcare, Inc. shall not be liable for loss of use or any other special, incidental, consequential or indirect costs, expenses or damages due to improper usage of this monitor. 1.5 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 Systolic BP Diastolic BP Normal Elevated Hypertension

< 120 mmHg and < 80 mmHg 120 - 129 mmHg and < 80 mmHg Stage 1 130 - 139 mmHg or 80 - 89 mmHg Stage 2 140 mmHg or 90 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 yourself based on your readings. ALWAYS consult with your physician. 2.4 Sitting Correctly To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. Place your arm on the table. Sit in a comfortable chair with your back and arm supported. Keep your feet flat and your legs uncrossed. The arm cuff should be placed on your arm at the same level as your heart, with the arm resting comfortably on a table. 3. Using Your Monitor without a Telehealth Service Receiver 3.1 Taking a Measurement You can use your monitor without pairing to a Telehealth service receiver. To pair your monitor with a receiver, refer to sub-section 4.1. Note To stop the measurement, press the [START/STOP] button once to deflate the arm cuff. This device tracks readings for one user. If you are sharing with another, please manually track your readings separately. Caution DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the devices and/

or cause an inaccurate reading. Remain still and DO NOT talk while taking a measurement. 1. Press the [START/STOP] button. All symbols appear on the display before starting the measurement. 2. Remain still and do not talk until the entire measurement process is complete. The 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 sub-

section 1.3), the symbol appears. START INFLATING DEFLATING COMPLETED 3. Press the [START/STOP] button to turn your monitor off. Note Your monitor automatically turns off after 2 minutes. Wait 2 - 3 minutes between measurements. The wait time allows the arteries to return to their pre-measurement state. You may need to increase the wait time depending on your individual physiological characteristics. If your systolic pressure is more than 210 mmHg If your systolic pressure is more than 210 mmHg, take a measurement manually. After the arm cuff starts to inflate, press and hold the [START/STOP]

button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure. 0.5 inch (1 to 2 cm) Note Do not inflate above 299 mmHg. Caution Bottom edge Bottom edge Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. 2. Preparation 2.1 Installing Batteries 1. Remove the battery cover. 2. Insert 4 AA batteries as indicated in the battery compartment. 3. Close the battery cover. symbol flashes on the display, it is recommended you Note When the replace batteries. To replace batteries, turn your monitor off and remove all batteries. Then replace with 4 new batteries at the same time. Replacing batteries will not delete previous readings. The supplied batteries may have a shorter life span than new batteries. Disposal of used batteries should be carried out in accordance with local regulations. 2.2 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 the 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. 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. 2.3 Applying the Arm Cuff Note The following steps are for applying the arm cuff to your left arm. When you take a measurement on your right arm, follow the cuff wrap instructions for a right arm use mentioned under To take a measurement on your right arm located at the end of this sub-section. The blood pressure can differ between the right arm and the left arm, and the measured blood pressure readings can be different. OMRON recommends to always use the same arm for measurement. If the readings between both arms differ substantially, check with your physician to determine as to which arm to use for your measurements. Caution Remove tight-fitting or thick clothing from your arm while taking a measurement. 1. Plug the arm cuff into your monitor by inserting the air plug into the air jack securely until it clicks. Click Note The bottom edge of the arm cuff should be 0.5 inch (1 to 2 cm) above the inside elbow. The air tube is on the inside of your arm and aligned with your middle finger. 3. Make sure that the air tube is positioned on the inside of your arm and wrap the cuff securely, so it can not move around your arm. To take a measurement on your right arm When you take a measurement on your right arm, the air tube should run along the side of your elbow, along the bottom of your arm. Be careful not to rest your arm on the air tube. When pressing the approximately 1.5 seconds before the pulse rate shows again on the display. button, the memory number appears for 2. Place your hand through the cuff loop. Pull the cuff until it reaches your upper left arm. 4. Using Your Monitor with a Telehealth Service Receiver 6. Other Settings Display/Problem Possible Cause Solution 9. Optional Accessories 4.1 Pairing Your Monitor with a Telehealth Service Receiver 1. Enable Bluetooth on the Telehealth service receiver. 2. Connect the monitor to the receiver. Refer to the provider's instructions for details. 3. Confirm that your monitor is connected successfully. When your monitor is connected successfully to the receiver, the OK symbol appears. 6.1 Restoring Your Monitor to the Default Settings To restore your monitors settings to the default settings and delete all readings, follow the instructions below. Make sure that your monitor is turned off. 1. Press the button. After a memory number appears, the latest reading will appear with a past reading. 4. Press the [START/STOP] button to turn your monitor off. 3. While holding the Note If the Err symbol appears, follow the provider's instructions. Your monitor automatically turns off after 10 seconds. Be aware that OMRON will not be responsible for the loss of data and/or information in the receiver. 4.2 Taking a Measurement Refer to sub-section 3.1 to start a measurement. Follow the provider's instructions. Note Make sure that your monitor is within 16 ft. (5m) of the receiver. Transferring Data Automatically When Bluetooth is enabled, the readings will be transferred to the receiver after taking a measurement. 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/ISED. 1. When your monitor is off, press and hold the button for more than 10 seconds. oFF flashes 3 times. 2. Press the [START/STOP] button to turn your monitor off. Note To enable the Bluetooth, press and hold the 3 seconds. on appears on the display. Your monitor automatically turns off 10 seconds after the completion. When Bluetooth is disabled, the symbol appears. button for more than 5. Using Memory Function Your monitor automatically stores up to 30 readings. 5.1 Viewing the Readings Stored in Memory 1. Press the button. The Memory number appears for 1.5 seconds before the pulse rate is displayed. The most recent reading stored in the memory will be numbered as 1. symbol appears. Note If the reading is high (refer to sub-section 1.3), the If there are no readings stored in the memory, the screen to the right is displayed. If the memory is full, new readings will replace the old readings, starting with the oldest reading. 2. Press the button repeatedly to scroll through the previous readings stored in the memory. 2. While holding the button down, press and hold the [START/

STOP] button for more than 4 seconds. The display to the right flashes. button down again, press and hold the

[START/STOP] button for more than 4 seconds. The display stops flashing, then your monitor is restored to the default settings. 4. Press the [START/STOP] button to turn your monitor off. Note Reverting to the default setting of your monitor does not delete the information in the Telehealth service receiver. Your monitor automatically turns off after 10 seconds. 7. Error Messages and Troubleshooting If any of the below problems occur during measurement, check to make sure that no other electrical device is within 12 inches (30 cm) of the monitor. If the problem persists, refer to the table below. Display/Problem Possible Cause Solution The [START/STOP]

button was pressed while the arm cuff is not applied. Press the [START/

STOP] button again to turn the monitor off. After inserting the air plug securely and applying the arm cuff correctly, press the [START/STOP]

button. appears or the arm cuff does not inflate. Air plug is not completely plugged into the monitor. Insert the air plug securely. Refer to sub-

section 2.3. The arm cuff is not applied correctly. Air is leaking from the arm cuff. You move or talk during a measurement and the arm cuff does not inflate sufficiently. The systolic pressure is above 210 mmHg and a measurement cannot be taken. appears or a measurement cannot be complete after the arm cuff inflates. appears The arm cuff is inflated exceeding the maximum allowable pressure. appears appears

appears does not flash during a measurement The pulse rate is not detected correctly. Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.3. Replace the arm cuff with a new one. Refer to section 9. Remain still and do not talk during a measurement. If E2 appears repeatedly, inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1. Inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1. Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to the end of sub-section 3.1. Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.3. Remain still and sit correctly during a measurement. If the continues to appear, we recommend you to consult with your physician. symbol You move or talk during a measurement. Vibrations disrupt a measurement. Remain still and do not talk during a measurement. appears The monitor has malfunctioned. The monitor cannot connect to a Telehealth service receiver or transmit data correctly. There are more than 24 readings in memory to be transferred. Your monitor is not paired or not connected with the receiver. There are 30 readings in memory to be transferred. Batteries are low. appears flashes appears flashes Press the [START/

STOP] button again. If Er still appears, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Follow the provider's instructions. If the Err symbol still appears after checking the receiver, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Pair or transfer your readings to the receiver so you can keep them in memory in the receiver, and this error symbol disappears. Replacing all 4 batteries with new ones is recommended. Refer to sub-section 2.1. Small D-Ring Cuff Arm circumference 7" - 9" (17 - 22 cm) Wide-Range D-Ring Cuff Arm circumference 9" - 17" (22 - 42 cm) Model:

Model:

HEM-CS24-B HEM-CS24-BZ HEM-RML31-B HEM-RML31-BZ Same as the arm cuff provided with the product. Note Do not throw the air plug away. The air plug can be applicable to the optional cuff. AC Adapter Model: HEM-ADPTW5 For further information, visit our website at OmronHealthcare.com Using the AC Adapter (optional accessory) Note Make sure not to place your monitor in a location where it is difficult to plug and unplug the AC adapter. and appears or the monitor is turned off unexpectedly during a measurement. Batteries are depleted. Immediately replace all 4 batteries with new ones. Refer to sub-section 2.1. 1. Insert the AC adapter plug into the AC adapter jack on the back side of your monitor. Batteries are depleted. Nothing appears on the display of the monitor. Battery polarities are not properly aligned. Check the battery installation for proper placement. Refer to sub-

section 2.1. Caution 2. Plug the AC adapter into an electrical outlet. To unplug the AC adapter, unplug the AC adapter from the electrical outlet and then remove the AC adapter plug from the monitor. Readings appear too high or too low. Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure. Review sub-sections 2.2 - 2.4 and section 3. Any other communication issue occurs. Follow the provider's instructions. If the problem still persists, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. 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 re-install batteries. If the problem still persists, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Any other problems occur. 8. Maintenance 8.1 Maintenance To protect your monitor from damage, 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 Store your monitor and other components in a clean, safe location. 1. Remove the arm cuff from the monitor. Caution To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. 2. Gently fold the air tube into the arm cuff. Note Do not bend or crease the air tube excessively. 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. 8.3 Cleaning Do not use any abrasive or volatile cleaners. Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff and then wipe them with a dry cloth. Do not wash or immerse your monitor and arm cuff or other components in water. Do not use gasoline, thinners or similar solvents to clean your monitor and arm cuff or other components. 8.4 Disposal Dispose of your monitor, other components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution. ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor. 10. Specifications Model Display Cuff pressure range Blood pressure measurement range Pulse measurement range Accuracy HEM-7145T2-Z BP9300T LCD digital display 0 to 299 mmHg SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg 40 to 180 beats / min. Pressure: 3 mmHg Pulse: 5 % of display reading Automatic by electric pump Automatic pressure release valve Inflation Deflation Measurement method Oscillometric method Transmission method Wireless communication Operation mode IP classification Rating Power source Battery life Durable period (Service life) Operating conditions Storage / Transport conditions Weight Dimensions Cuff circumference applicable to the monitor Memory Contents Protection against electric shock Applied part Bluetooth Low Energy Frequency range: 2.4 GHz (2400 - 2483.5 MHz) Modulation: GFSK Effective radiated power: < 20 dBm Continuous operation Monitor: IP20 Optional AC adapter: IP21 DC6 V 4 W 4 AA batteries 1.5 V or optional AC adapter

(INPUT AC100 - 240 V 50 - 60 Hz 0.12 - 0.065 A) Approximately 500 measurements (using new alkaline batteries) Monitor: 5 years Arm cuff: 5 years Optional AC adapter: 5 years

+50 F to +104 F (+10 C to +40 C) / 15 to 90 % RH (non-condensing) / 800 to 1060 hPa

-4 F to +140 F (-20 C to +60 C) / 10 to 90 %

RH (non-condensing) Monitor: Approximately 8.8 oz. (250 g) not including batteries Arm cuff: Approximately 6 oz. (170 g) Monitor: Approximately 4.1" (w) 3.2" (h) 5.5"

(l) (103 mm 82 mm 140 mm) Arm cuff: Approximately 5.7" 23.4" (air tube:

29.5") (145 mm 594 mm (air tube: 750 mm)) 7" to 17" (17 to 42 cm) (included arm cuff: 9" to 17" (22 to 42 cm)) Stores up to 30 readings Monitor, Wide-Range D-Ring Cuff, 4 AA batteries, instruction manual, quick start guide Internally powered ME equipment (When using only batteries) Class II ME equipment (Optional AC adapter) Type BF (arm cuff) Note These specifications are subject to change without notice. This monitor is clinically investigated according to the requirements of ISO 81060-2:2013 and complies with ISO 81060-2:2013 and ISO 81060-2:2018+A1:2020. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. 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 and optional AC adapter are protected against solid foreign objects of 0.5 inch (12.5 mm) diameter and greater such as a finger. The optional AC adapter is protected against vertically falling water drops which may cause issues during a normal operation. Operation mode classification complies with IEC 60601-1. 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. Pictogram on the Product or Types of marks used to indicate the correct positioning of the artery for the upper arm Identifies the type of cuff that is compatible with the blood pressure monitor 11. FCC/ISED 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 FCC Rules and Innovation, Science and Economic Development Canadas licence-exempt RSS(s). 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 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. This equipment complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the ISED radio frequency (RF) Exposure rules as this equipment has very low levels of RF energy. 12. Limited Warranty Your BP9300T Blood Pressure Monitor, excluding the arm cuff and batteries, is warranted to be free from defects in materials and workmanship appearing within 2 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The arm cuff is warranted to be free from defects in materials and workmanship appearing within 1 year from the date of purchase when the monitor is used in accordance with the instructions provided with the monitor. The above warranty extends only to the original retail purchaser, and only to products purchased from an OMRON authorized seller who is subject to and follows OMRON's quality control standards, unless otherwise prohibited by law. We will, at our option, replace without charge any monitor or arm cuff covered by the above warranty. Replacement is our only responsibility and your only remedy under the above warranty. To obtain warranty service contact your Telehealth service provider or contact OMRON at 1-800-634-4350 for the address of the inspection center and the return shipping and handling fee that may apply. 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, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. 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. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. 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:

Call toll free:

For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca 1-800-634-4350 13. Guidance and Manufacturers Declaration OMRON Battery-operated / AC Adapter-operated Blood Pressure Monitor Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility

(EMC) BP9300T 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 BP9300T 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 under license. Other trademarks and trade names are those of their respective owners. OMRON HEALTHCARE Co., Ltd. 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN Distributed by:

OMRON HEALTHCARE, INC. 2895 Greenspoint Pkwy. Hoffman Estates, IL 60169 USA For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca 2022 OMRON HEALTHCARE, INC. Made in Vietnam

3293798-0A Blood Pressure Monitor Model BP9310T Instruction Manual Table of Contents Introduction Important Safety Information 1. Know Your Monitor 2. Preparation 3. Using Your Monitor without a Telehealth Service Receiver 4. Using Your Monitor with a Telehealth Service Receiver 5. Using Memory Function 6. Other Settings 7. Error Messages and Troubleshooting 8. Maintenance 9. Optional Accessories 10. Specifications 11. FCC/ISED Statement 12. Limited Warranty 13. Guidance and Manufacturers Declaration Introduction Thank you for purchasing the OMRON BP9310T Blood Pressure Monitor. This monitor can be used by multiple users. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. Safety Instructions This instruction manual provides you with important information about the OMRON BP9310T Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact your Telehealth service provider or contact OMRON at 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with readings. Environments of Use: Home Patient Population: Adult Receiving and Inspection Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and contact your Telehealth service provider or contact OMRON at 1-800-634-4350. 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 Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN. Warning 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 arm or an arm under medical treatment. DO NOT apply the arm cuff on your arm 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. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. DO NOT use this monitor in oxygen rich environments or near flammable gas. 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. To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children. This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and 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, remove batteries and/or unplug the AC adapter when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/ISED. AC Adapter (optional accessory) Handling and Usage DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately. Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug. NEVER plug in or unplug the AC adapter from the electric outlet with wet hands. DO NOT disassemble or attempt to repair the AC adapter. Battery Handling and Usage Keep batteries out of the reach of infants, toddlers and 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 an arm where intravascular access or therapy, or an arterio-venous (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 arm cuff when it is applied on your upper arm. Remove the arm 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 emits 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 section 10. 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. DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the devices 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 or thick clothing from your arm while taking a measurement. Remain still and DO NOT talk while taking a measurement. ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff. Ensure that this monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature. For additional information on operating and storage/transport temperature, refer to section 10. DO NOT use this monitor after the durable period has ended. Refer to section 10. DO NOT crease the arm cuff or the air tube excessively. DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood flow. To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor. ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings. Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. NOTE: refer to If your systolic pressure is more than 210 mmHg in section 3 of this instruction manual for additional information. Data Transmission DO NOT replace batteries or unplug the AC adapter while your readings are being transferred to the Telehealth service receiver. This may result in incorrect operation of this monitor and failure to transfer your blood pressure data. AC Adapter (optional accessory) Handling and Usage Fully insert the AC adapter into the outlet. When unplugging the AC adapter from the outlet, be sure to safely pull from the AC adapter. DO NOT pull from the AC adapter cable. When handling the AC adapter cable:

DO NOT damage it. DO NOT break it. DO NOT tamper with it. DO NOT forcibly bend or pull it. DO NOT twist it. DO NOT use it if it is gathered in a bundle. DO NOT pinch 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. Battery Handling and Usage DO NOT insert batteries with their polarities incorrectly aligned. ONLY use 4 AA alkaline or manganese 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. 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. 1. Know Your Monitor 1.1 Contents/Product Includes Monitor, Wide-Range D-Ring Cuff, 4 AA batteries, instruction manual, quick start guide 1.2 Monitor and Arm Cuff Front of the monitor a b c Display

[Connection] button

(Memory)

[START/STOP] button Left side, back and bottom of the monitor Air jack AC adapter jack

(for optional AC adapter) Battery compartment d e f g h Air plug Air tube Arm cuff

(Upper arm circumference: 9" - 17" (22 - 42 cm)) 1.3 Display and Symbols a b A B C D E F c d e f g h G H I J K L M OK symbol Flashes when your monitor is connected to the Telehealth service receiver successfully. Bluetooth ON symbol Appears when your readings are being transferred. Bluetooth OFF symbol Appears when Bluetooth is disabled. Systolic blood pressure reading Diastolic blood pressure reading Heartbeat symbol Flashes while taking a measurement. Deflation symbol Appears during cuff deflation. Sync symbol Flashes: the stored memory is almost full Appears: the stored memory is completely full Once you pair your monitor with the receiver, transfer your readings immediately before the monitor deletes the oldest reading. Up to 30 readings can be stored in the internal memory of your monitor. Memory symbol Appears when viewing readings stored in the memory. High symbol Appears if your systolic blood pressure is 130 mmHg or the diastolic blood pressure is 80 mmHg. Refer to sub-

section 1.5 for more information. Movement error symbol Appears with your reading when your body is moving during a measurement. If it appears, remove the arm cuff and wait for 2 to 3 minutes. Then, reapply the cuff, remain still and take another measurement. Irregular heartbeat symbol Appears when irregular rhythm is detected 2 or more times during a 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 blood pressure. Short Long Irregular Heartbeat Normal Heartbeat Irregular heartbeat symbol may be displayed when the monitor detects arm movements. Refer to section 7 for more information. If it continues to appear, we recommend you to consult with and follow the directions of your physician. Low battery symbol Flashes when batteries are low. Depleted battery symbol Appears when batteries are depleted. Pulse display / Memory number Pulse rate appears after the measurement. A B C D E F G H I J K L M 1.4 Wireless Function Before use, thoroughly read the instruction manual included with the Telehealth service receiver (in some cases, receiver may be your smart device) being used with this blood pressure monitor, for instructions about your monitor connecting to the Telehealth service receiver, and receiver transmission range. It will be necessary for the blood pressure monitor to be within the receivers transmission range to successfully transfer data. This OMRON blood pressure monitor is designed to connect to specific Bluetooth receivers, and is not guaranteed to connect to all Bluetooth compatible devices and Telehealth service receivers. OMRON Healthcare, Inc. shall not be liable for loss of use or any other special, incidental, consequential or indirect costs, expenses or damages due to improper usage of this monitor. 1.5 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 Systolic BP Diastolic BP Normal Elevated Hypertension

< 120 mmHg and < 80 mmHg 120 - 129 mmHg and < 80 mmHg Stage 1 130 - 139 mmHg or 80 - 89 mmHg Stage 2 140 mmHg or 90 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 yourself based on your readings. ALWAYS consult with your physician. 2.4 Sitting Correctly To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. Place your arm on the table. Sit in a comfortable chair with your back and arm supported. Keep your feet flat and your legs uncrossed. The arm cuff should be placed on your arm at the same level as your heart, with the arm resting comfortably on a table. 3. Using Your Monitor without a Telehealth Service Receiver 3.1 Taking a Measurement You can use your monitor without pairing to a Telehealth service receiver. To pair your monitor with a receiver, refer to sub-section 4.1. Note To stop the measurement, press the [START/STOP] button once to deflate the arm cuff. This device tracks readings for one user. If you are sharing with another, please manually track your readings separately. Caution DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the devices and/

or cause an inaccurate reading. Remain still and DO NOT talk while taking a measurement. 1. Press the [START/STOP] button. All symbols appear on the display before starting the measurement. 2. Remain still and do not talk until the entire measurement process is complete. The 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 sub-

section 1.3), the symbol appears. START INFLATING DEFLATING COMPLETED 3. Press the [START/STOP] button to turn your monitor off. Note Your monitor automatically turns off after 2 minutes. Wait 2 - 3 minutes between measurements. The wait time allows the arteries to return to their pre-measurement state. You may need to increase the wait time depending on your individual physiological characteristics. If your systolic pressure is more than 210 mmHg If your systolic pressure is more than 210 mmHg, take a measurement manually. After the arm cuff starts to inflate, press and hold the [START/STOP]

button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure. 0.5 inch (1 to 2 cm) Note Do not inflate above 299 mmHg. Caution Bottom edge Bottom edge Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. 2. Preparation 2.1 Installing Batteries 1. Remove the battery cover. 2. Insert 4 AA batteries as indicated in the battery compartment. 3. Close the battery cover. symbol flashes on the display, it is recommended you Note When the replace batteries. To replace batteries, turn your monitor off and remove all batteries. Then replace with 4 new batteries at the same time. Replacing batteries will not delete previous readings. The supplied batteries may have a shorter life span than new batteries. Disposal of used batteries should be carried out in accordance with local regulations. 2.2 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 the 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. 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. 2.3 Applying the Arm Cuff Note The following steps are for applying the arm cuff to your left arm. When you take a measurement on your right arm, follow the cuff wrap instructions for a right arm use mentioned under To take a measurement on your right arm located at the end of this sub-section. The blood pressure can differ between the right arm and the left arm, and the measured blood pressure readings can be different. OMRON recommends to always use the same arm for measurement. If the readings between both arms differ substantially, check with your physician to determine as to which arm to use for your measurements. Caution Remove tight-fitting or thick clothing from your arm while taking a measurement. 1. Plug the arm cuff into your monitor by inserting the air plug into the air jack securely until it clicks. Click Note The bottom edge of the arm cuff should be 0.5 inch (1 to 2 cm) above the inside elbow. The air tube is on the inside of your arm and aligned with your middle finger. 3. Make sure that the air tube is positioned on the inside of your arm and wrap the cuff securely, so it can not move around your arm. To take a measurement on your right arm When you take a measurement on your right arm, the air tube should run along the side of your elbow, along the bottom of your arm. Be careful not to rest your arm on the air tube. When pressing the approximately 1.5 seconds before the pulse rate shows again on the display. button, the memory number appears for 2. Place your hand through the cuff loop. Pull the cuff until it reaches your upper left arm. Small D-Ring Cuff Wide-Range D-Ring Cuff Arm circumference 7" - 9" (17 - 22 cm) Arm circumference 9" - 17" (22 - 42 cm) Extra Large Cuff Arm circumference 17" - 20" (42 - 50 cm) Model:

HEM-CS24-B HEM-CS24-BZ Model:

HEM-RML31-B HEM-RML31-BZ Same as the arm cuff provided with the product. Model:

HEM-RXL31-B HEM-RXL31-BZ Note Do not throw the air plug away. The air plug can be applicable to the optional cuff. AC Adapter Pictogram on the Product Note These specifications are subject to change without notice. This monitor is clinically investigated according to the requirements of ISO 81060-2:2013 and complies with ISO 81060-2:2013 and ISO 81060-2:2018+A1:2020. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. 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 and optional AC adapter are protected against solid foreign objects of 0.5 inch (12.5 mm) diameter and greater such as a finger. The optional AC adapter is protected against vertically falling water drops which may cause issues during a normal operation. Operation mode classification complies with IEC 60601-1. 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. or Types of marks used to indicate the correct positioning of the artery for the upper arm Identifies the type of cuff that is compatible with the blood pressure monitor 11. FCC/ISED 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 FCC Rules and Innovation, Science and Economic Development Canadas licence-exempt RSS(s). 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 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. This equipment complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the ISED radio frequency (RF) Exposure rules as this equipment has very low levels of RF energy. 12. Limited Warranty Your BP9310T Blood Pressure Monitor, excluding the arm cuff and batteries, is warranted to be free from defects in materials and workmanship appearing within 2 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The arm cuff is warranted to be free from defects in materials and workmanship appearing within 1 year from the date of purchase when the monitor is used in accordance with the instructions provided with the monitor. The above warranty extends only to the original retail purchaser, and only to products purchased from an OMRON authorized seller who is subject to and follows OMRON's quality control standards, unless otherwise prohibited by law. We will, at our option, replace without charge any monitor or arm cuff covered by the above warranty. Replacement is our only responsibility and your only remedy under the above warranty. To obtain warranty service contact your Telehealth service provider or contact OMRON at 1-800-634-4350 for the address of the inspection center and the return shipping and handling fee that may apply. 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, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. 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. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. 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:

Call toll free:

For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca 1-800-634-4350 13. Guidance and Manufacturers Declaration OMRON Battery-operated / AC Adapter-operated Blood Pressure Monitor Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility

(EMC) BP9310T 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 BP9310T on the website. Batteries are low. For further information, visit our website at OmronHealthcare.com Model: HEM-ADPTW5 Using the AC Adapter (optional accessory) Note Make sure not to place your monitor in a location where it is difficult to plug and unplug the AC adapter. 1. Insert the AC adapter plug into the AC adapter jack on the back side of your monitor. Check the battery installation for proper placement. Refer to sub-

section 2.1. 2. Plug the AC adapter into an electrical outlet. To unplug the AC adapter, unplug the AC adapter from the electrical outlet and then remove the AC adapter plug from the monitor. Readings appear too high or too low. Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure. Review sub-sections 2.2 - 2.4 and section 3. Caution 4. Using Your Monitor with a Telehealth Service Receiver 6. Other Settings Display/Problem Possible Cause Solution 9. Optional Accessories 4.1 Pairing Your Monitor with a Telehealth Service Receiver 1. Enable Bluetooth on the Telehealth service receiver. 2. Connect the monitor to the receiver. Refer to the provider's instructions for details. 3. Confirm that your monitor is connected successfully. When your monitor is connected successfully to the receiver, the OK symbol appears. 6.1 Restoring Your Monitor to the Default Settings To restore your monitors settings to the default settings and delete all readings, follow the instructions below. Make sure that your monitor is turned off. 1. Press the button. After a memory number appears, the latest reading will appear with a past reading. 4. Press the [START/STOP] button to turn your monitor off. 3. While holding the Note If the Err symbol appears, follow the provider's instructions. Your monitor automatically turns off after 10 seconds. Be aware that OMRON will not be responsible for the loss of data and/or information in the receiver. 4.2 Taking a Measurement Refer to sub-section 3.1 to start a measurement. Follow the provider's instructions. Note Make sure that your monitor is within 16 ft. (5m) of the receiver. Transferring Data Automatically When Bluetooth is enabled, the readings will be transferred to the receiver after taking a measurement. 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/ISED. 1. When your monitor is off, press and hold the button for more than 10 seconds. oFF flashes 3 times. 2. Press the [START/STOP] button to turn your monitor off. Note To enable the Bluetooth, press and hold the 3 seconds. on appears on the display. Your monitor automatically turns off 10 seconds after the completion. When Bluetooth is disabled, the symbol appears. button for more than 5. Using Memory Function Your monitor automatically stores up to 30 readings. 5.1 Viewing the Readings Stored in Memory 1. Press the button. The Memory number appears for 1.5 seconds before the pulse rate is displayed. The most recent reading stored in the memory will be numbered as 1. symbol appears. Note If the reading is high (refer to sub-section 1.3), the If there are no readings stored in the memory, the screen to the right is displayed. If the memory is full, new readings will replace the old readings, starting with the oldest reading. 2. Press the button repeatedly to scroll through the previous readings stored in the memory. 2. While holding the button down, press and hold the [START/

STOP] button for more than 4 seconds. The display to the right flashes. button down again, press and hold the

[START/STOP] button for more than 4 seconds. The display stops flashing, then your monitor is restored to the default settings. 4. Press the [START/STOP] button to turn your monitor off. Note Reverting to the default setting of your monitor does not delete the information in the Telehealth service receiver. Your monitor automatically turns off after 10 seconds. 7. Error Messages and Troubleshooting If any of the below problems occur during measurement, check to make sure that no other electrical device is within 12 inches (30 cm) of the monitor. If the problem persists, refer to the table below. Display/Problem Possible Cause Solution The [START/STOP]

button was pressed while the arm cuff is not applied. Press the [START/

STOP] button again to turn the monitor off. After inserting the air plug securely and applying the arm cuff correctly, press the [START/STOP]

button. The arm cuff is not applied correctly. Air is leaking from the arm cuff. You move or talk during a measurement and the arm cuff does not inflate sufficiently. The systolic pressure is above 210 mmHg and a measurement cannot be taken. appears or a measurement cannot be complete after the arm cuff inflates. appears The arm cuff is inflated exceeding the maximum allowable pressure. appears appears

appears does not flash during a measurement The pulse rate is not detected correctly. Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.3. Replace the arm cuff with a new one. Refer to section 9. Remain still and do not talk during a measurement. If E2 appears repeatedly, inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1. Inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1. Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to the end of sub-section 3.1. Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.3. Remain still and sit correctly during a measurement. If the continues to appear, we recommend you to consult with your physician. symbol You move or talk during a measurement. Vibrations disrupt a measurement. Remain still and do not talk during a measurement. appears The monitor has malfunctioned. The monitor cannot connect to a Telehealth service receiver or transmit data correctly. There are more than 24 readings in memory to be transferred. Your monitor is not paired or not connected with the receiver. There are 30 readings in memory to be transferred. appears flashes appears flashes Press the [START/

STOP] button again. If Er still appears, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Follow the provider's instructions. If the Err symbol still appears after checking the receiver, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Pair or transfer your readings to the receiver so you can keep them in memory in the receiver, and this error symbol disappears. Replacing all 4 batteries with new ones is recommended. Refer to sub-section 2.1. and appears or the monitor is turned off unexpectedly during a measurement. Batteries are depleted. Immediately replace all 4 batteries with new ones. Refer to sub-section 2.1. Batteries are depleted. Nothing appears on the display of the monitor. Battery polarities are not properly aligned. 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 re-install batteries. If the problem still persists, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Any other problems occur. 8. Maintenance 8.1 Maintenance To protect your monitor from damage, 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 Store your monitor and other components in a clean, safe location. 1. Remove the arm cuff from the monitor. Caution To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. 2. Gently fold the air tube into the arm cuff. Note Do not bend or crease the air tube excessively. 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. 8.3 Cleaning Do not use any abrasive or volatile cleaners. Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff and then wipe them with a dry cloth. Do not wash or immerse your monitor and arm cuff or other components in water. Do not use gasoline, thinners or similar solvents to clean your monitor and arm cuff or other components. 8.4 Disposal Dispose of your monitor, other components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution. appears or the arm cuff does not inflate. Air plug is not completely plugged into the monitor. Insert the air plug securely. Refer to sub-

section 2.3. Any other communication issue occurs. Follow the provider's instructions. If the problem still persists, contact your Telehealth service provider or contact OMRON at 1-800-634-4350. ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor. 10. Specifications Model Display Cuff pressure range Blood pressure measurement range Pulse measurement range Accuracy HEM-7149T2-Z BP9310T LCD digital display 0 to 299 mmHg SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg 40 to 180 beats / min. Pressure: 3 mmHg Pulse: 5 % of display reading Automatic by electric pump Automatic pressure release valve Inflation Deflation Measurement method Oscillometric method Transmission method Wireless communication Operation mode IP classification Rating Power source Battery life Durable period (Service life) Operating conditions Storage / Transport conditions Weight Dimensions Cuff circumference applicable to the monitor Memory Contents Protection against electric shock Applied part Bluetooth Low Energy Frequency range: 2.4 GHz (2400 - 2483.5 MHz) Modulation: GFSK Effective radiated power: < 20 dBm Continuous operation Monitor: IP20 Optional AC adapter: IP21 DC6 V 4 W 4 AA batteries 1.5 V or optional AC adapter

(INPUT AC100 - 240 V 50 - 60 Hz 0.12 - 0.065 A) Approximately 500 measurements (using new alkaline batteries) Monitor: 5 years Arm cuff: 5 years Optional AC adapter: 5 years

+50 F to +104 F (+10 C to +40 C) / 15 to 90 % RH (non-condensing) / 800 to 1060 hPa

-4 F to +140 F (-20 C to +60 C) / 10 to 90 %

RH (non-condensing) Monitor: Approximately 8.8 oz. (250 g) not including batteries Arm cuff: Approximately 6 oz. (170 g) Monitor: Approximately 4.1" (w) 3.2" (h) 5.5"

(l) (103 mm 82 mm 140 mm) Arm cuff: Approximately 5.7" 23.4" (air tube:

29.5") (145 mm 594 mm (air tube: 750 mm)) 7" to 20" (17 to 50 cm) (included arm cuff: 9" to 17" (22 to 42 cm)) Stores up to 30 readings Monitor, Wide-Range D-Ring Cuff, 4 AA batteries, instruction manual, quick start guide Internally powered ME equipment (When using only batteries) Class II ME equipment (Optional AC adapter) Type BF (arm cuff) 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. OMRON HEALTHCARE Co., Ltd. 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN Distributed by:

OMRON HEALTHCARE, INC. 2895 Greenspoint Pkwy. Hoffman Estates, IL 60169 USA For USA - OmronHealthcare.com For Canada - OmronHealthcare.ca 2022 OMRON HEALTHCARE, INC. Made in Vietnam

Confidential B IC: XXXXX-XXXXXXXX will be replaced by IC:10623A-HEM7145T2. FCC ID: XXX-XXXXXXX will be replaced by FCC ID: Q6ZMHEM7145T2.

*Due to the size of product, the statement required by FCC 15.19(a) will be printed on users manual. Confidential B IC: XXXXX-XXXXXXXX will be replaced by IC:10623A-HEM7145T2. FCC ID: XXX-XXXXXXX will be replaced by FCC ID: Q6ZMHEM7145T2.

**Due to the size of product, the statement require by FCC 15.19(a) will be printed on users manual.

Letter of Aqtiorizagen Date: Jnntiary 17, 2022 UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 Applicant; OMRON HEALTHCARE Co.,Ltd FCC ID: Q6ZMHEM7145T2 To whom it may concern:

We, the undersigned, hereby authorize Yukari Ito of Consumer, Medical & Information Technologies Division, UL Japan, Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Japan, Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. OP This authorization is valid until further written notice from the applicant. The application for the subject equipment has not been submitted to another TCB for certification. OMRON HEALTHCARE Co., Ltd All for Healthcare 53, Kunotsubo, Terado-cho, Muko,KYOTO,617-0002 JAPAN Toshiaki Yuasa OMRON HEALTHCARE Co.,Ltd Sincerely Yours, Letter of Authorization Date: January 17, 2022

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i UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 Applicant: OMRON HEALTHCARE Co.,Ltd FCCID : Q6ZMHEM7145T2 To whom it may concern:

Please be advised that the following information is to be held confidential on behalf of us, referring to the FCC rules 0.457 and 0.459:

Date: January 17, 2022 Block Diagram Theory of Operation Schematics The application contains technical information which we deem to be trade secrets and proprietary. If made public, the information might be used to the disadvantage of the applicant in the market place. OMRON HEALTHCARE Co., Ltd 3,Kunotsubo, Terado-cho,Muko,KYOTO,617-0002 JAPAN All for Healthcare Toshiaki Yuasa OMRON HEALTHCARE Co.,Ltd Thank you for your attention to this matter. Request for Confidentiality

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Ae poe Se ee eee UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 FCC ID : Q6ZMHEM7145T2 Applicant: OMRON HEALTHCARE Co.,Ltd To whom it may concern:

Please be advised that the following information is to be held in confidence for 80 days from the date of the Grant of Equipment Authorization and behalf of us, referring to the FCC rules 0.457 and 0.459:

Date: January 17, 2022 The application contains technical information, which we deem to be trade secrets and proprietary. If made public, the information might be used to the disadvantage of the applicant in the market place. Thank you for your attention to this matter. External Photos Internal Photos Test Setup Photos User Manual Toshiaki Yuasa OMRON HEALTHCARE Co.,Ltd OMRON HEALTHCARE Go., Ltd 53, Kunotsubo, Terado-cho,Muko,KYOTO,617-0002 JAPAN All for Healthcare Request for Short-Term Confidentiality