Tanita Wrist Blood Pressure Monitor BP-215 Series BP-219L

[Please refer to the instruction manual.]

1. General name of medical device: Automatic electronic blood pressure monitor

2. Product name: Tanita Wrist Blood Pressure Monitor BP-215 Series

3. Contraindications/Prohibitions How to use ・Do not use if any abnormality is detected in the device before or during use. [There is a risk of injury or accident.] ・Do not self-interpret the measurement results. [Self-interpretation may worsen the condition.] ・Do not wrap the cuff around an arm that is undergoing treatment or is injured and measure blood pressure. /Do not wrap the cuff around an arm that has undergone endovascular intubation or arteriovenous shunting and measure blood pressure./Do not wrap the cuff around an arm on the side where a mastectomy has been performed and measure blood pressure. [There is a risk of worsening the symptoms.] ・Do not use near flammable or combustible gases. [There is a risk of fire or explosion due to ignition or combustion.] ]

4. Item Specifications, etc. Standards related to performance and safety, etc. (1) Error in blood pressure measurement by clinical performance test: Average error with auscultation method: within ±5 mmHg Standard deviation: within ±8 mmHg (2) Pressure display error due to environmental conditions: ±3 mmHg (0~300 mmHg) (3) Stopping operation: Reduce pressure to 15 mmHg within 30 seconds after switching off the switch (4) Reproducibility of blood pressure measurement: 3 mmHg or less (5) Maximum pressure under normal conditions: 300 mmHg (6) Blood pressure measurement: Diastolic blood pressure range: 40~130 mmHg Systolic blood pressure range: 60~255 mmHg Accuracy: ±3 mmHg (7) Pulse rate measurement: Range: 40~199 beats/min, Accuracy: ±4%

5. Precautions for Use Important Basic Precautions 1. Usage Environment and Conditions (1) Do not use without a doctor's instructions if you have severe circulatory disorders in your arm. (2) Do not use without a doctor's instructions if you are using anticoagulants, antiplatelet agents, steroids, etc., or if you are undergoing dialysis treatment. (3) Do not allow physically disabled individuals to measure alone. (4) Do not allow children or individuals who cannot express their wishes or operate the device to use it alone. (5) Keep out of reach of infants and young children, and do not use on infants and young children. (6) Do not heat the device or batteries. (7) Do not use new batteries and used batteries, or batteries of different types, at the same time. (8) When inserting batteries, do not reverse the polarity (⊕, ⊖). (9) Do not leave batteries in if not using for a long period of time. (10) Do not install or replace batteries with wet hands. (11) If you have advanced hypertension, dyslipidemia, arteriosclerosis, etc., consult a doctor and use with caution. (12) Use with caution if you have increased capillary vulnerability to external pressure. (13) Do not use on an unspecified number of people, such as in medical facilities or public places. (14) Do not use in places that emit static electricity or electromagnetic waves (near induction cookers, microwave ovens, communication equipment, etc.). (15) Do not use in combination with other medical devices. (16) Do not measure or leave in environments with active gases (including disinfectant gases), dusty places, or high temperature and humidity environments. (17) If stored in a cold room for a long time, leave it in a warm place for at least one hour before use. Other Basic Precautions 2. Precautions Before Use (1) Never disassemble, modify, or repair the main unit or cuff. (2) Do not use for purposes other than blood pressure measurement. (3) Check the condition of the application site, and do not measure if any abnormality is found. (4) Do not wrap the cuff anywhere other than the wrist. (5) Do not drop the device or subject it to strong impacts. (6) Do not forcibly stretch or bend the cuff. (7) Do not cut or poke the cuff with a sharp object. (8) Do not wash the device with water. (9) Do not use chemicals such as alcohol, hot water, benzene, thinner, or bleach. (10) Do not use batteries other than those specified. (11) Ensure that no foreign objects or waves enter the device. (12) If the arm to be measured is wet with sweat, etc., be sure to wipe it thoroughly and dry it. Use after application (13) When measuring continuously, measure at intervals of 10 minutes or more. (14) If congestion occurs after continuous use, remove the congestion before measuring. 6. Name or designation of manufacturer and distributor Manufacturer/Distributor: Tanita Akita Corporation Address: 28-1 Shimoda Mogizoe, Horiminai, Daisen City, Akita Prefecture Phone number: 0187-66-2122 Manufacturer: Tanita Corporation Inquiries: Customer Service Consultation Office Address: 1-14-2 Maenocho, Itabashi-ku, Tokyo Phone number: 0120-133821 0570-783551 (for mobile phones) Manufacturer: AViTA Corporation (Taiwan)

7. Intended use or effect To measure systolic and diastolic blood pressure non-invasively at home under the guidance of a physician for health management. Medical device classification: Specified controlled medical device Medical device certification number: 305AFBZX00008000 A list of compatible smartphone models and OS versions can be found on the Tanita website.