FCC ID: 2ABAFMD3610B Digital Automatic Blood Pressure Monitor with Bluetooth Low Energy

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6087426.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR MD3600B / MD3610B Instructions for use Blood pressure monitor Instructions for use The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on. WarningDont near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WarningPortable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Digital Automatic Blood Pressure Monitor (MD3610B, MD3600B), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. If anya list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE). If anythe performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term ESSENTIAL PERFORMANCE need not be used). 1. IMPORTANT SAFETY NOTES Signs and symbols Whenever used, the following signs identify safety and property damage messages and designate a level of hazard or seriousness. READ THIS ENTIRE MANUAL, THE SAFETY SEC TION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUC TIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT. This is the safety alert symbol. It alerts you to potential personal injury hazards. Obey all safety messages that follow this symbol to avoid possible injury or death. WARNING WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. 1 CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. NOTICE addresses practi-

ces not related to person-

al injury, such as product and/or property damage. NOTICE WARNING:

Consult your physician or pharmacist before start-

ing to measure your blood pressure. Read and understand all instructions and warnings before using this device. Like any oscillometric blood pressure measure-

ment devices, certain medical conditions can af-

fect the measurement accuracy, among others:

disorder of the cardiac rhythm very low blood pressure patients in shock patients with very low blood perfusion diabetes 2 people with electrical implants, such as a cardiac pacemaker people with renal diseases women who are pregnant patient motion during measurement pre-eclamptic people. Due to their condition the oscillometric measure-

ment method can produce incorrect readings. This represents a risk for your health, since values may be interpreted incorrectly. Always consult your physician to determine what will be suitable for you. This product does not and is not intended to pro-

vide a medical diagnosis. Measurements results are for reference only. Self-diagnosis and treatment, e.g. regarding medication, using measured results represent a risk for your health. Always consult with a licensed physician for determination of appro-

priate medication and dosage thereof. Follow the instructions of your physician or licensed health-

care provider. If you have or suspect that you have a medical problem, promptly consult your phys-

ician. If you have an emergency please call 911 im-

mediately. Only a physician or a trained health care profession-

al who is familiar with your medical history is able to accurately interpret your blood pressure meas-

urements. Consult your physician before starting blood pressure monitoring. This product is not intended to serve as a substi-

tute for the advice of a physician or medical profes-

sional. This product is not intended to substitute for regular medical checkups. Contact your physician for specific information about your blood pressure. Please note that technically related measuring toler-

ances are possible. Please see section 12. Speci-

fications for details. NOTE: A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record sev-

eral readings over a period of time. Try to measure your blood pressure at the same time each day for consistency. Any cuff related blood pressure measurement in high repetition rates, can lead to severe measure-

ment side effects, e.g. any nerv compression with temporary arm/hand paralysis the release of an arterial or venous thrombus, which can cause a life threatening situation. Please contact your physician about the specific risks of cuff pressure in your specific case. The irregular heartbeat function does not replace a cardiac examination, but may help to detect po-

tential pulse irregularities at an early stage. Always consult your physician to determine what will be suitable for you. The irregular heartbeat function is not designed for diagnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician. The WHO chart is not intended to replace a medical diagnosis. This chart is only a reference for differ-

ent classifications of blood pressure. If you notice abnormal or suspicious variations in blood pressure measurements, consult your phys-

ician immediately. Women who underwent a breast or axillar lymph node removal operation should consult a phys-

ician or licensed healthcare provider before start-

ing blood pressure measurements. 3 Prior to use, you have to ensure that the blood pres-

sure monitor is free of damage. If in doubt, do not use the unit and contact customer service at 1-800-

536-0366. This device is intended only for personal, non-com-

mercial, adult use in measuring blood pressure and pulse rate. Do not use the product for any other purpose. This product is not intended for use in a hospital, physicians oice, or any other health care facility. The unit must be used in accordance to the speci-

fied ambient conditions, otherwise the accuracy of readings might be affected. See section 10. Care and Maintenance and section 12. Specifications for details. Do not wrap the cuff around body parts other than your arm. Misuse represents a risk to your health. Please do not share the cuff with other persons, to avoid cross infection. Use this monitor only on humans. This product is not intended for use by or on chil-

dren, toddlers and infants or on persons who can-

not express their consent, e.g. persons with men-

tal disorders or the like. Consult your physician for alternative methods of measuring a childs blood pressure. This product is not a toy. Keep it out of reach of children, toddlers, and infants. Keep the product out of the reach of pets. Packaging materials are a deadly hazard for chil-

dren and can cause suffocation. Remove all pack-

aging materials immediately and keep them away from children at all times. This product contains small parts that may present a choking hazard to children. Keep the unit and all parts out of reach of children. NEVER LEAVE CHIL-

DREN OR THOSE WHO REQUIRE CLOSE SUPER-

VISION UNATTENDED WITH THIS DEVICE. The tubing presents a strangulation hazard. Keep this product away from children and those who re-

quire close supervision, e.g. people with mental disorders. NEVER LEAVE CHILDREN OR THOSE WHO REQUIRE CLOSE SUPERVISION UNATTEND-

ED WITH THIS DEVICE. Do not drape tube around neck. This presents a strangulation hazard. 4 People with disabilities, activity limitations, or who are physically frail, should be assisted by another person when using this unit. Do not measure your blood pressure while oper-

ating a vehicle or in any situation which requires your full attention. Proper cuff size is important for accurate measure-

ments. Only use the device on adults who have the right upper arm circumference for this instrument. See section 12. Specifications for suitable upper arm circumferences. Do not use any cuffs, tubes, parts and accessor-

ies other than those explicitly recommended by the manufacturer for use with this product. Parts and accessories not approved for use with the de- vice may cause damage to your health and to the product. Electromagnetic interference: Avoid strong elec-

trical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens) while it is in operation, as inaccurate meas-

urements may result. To prevent such interference, use the unit at a suicient distance from such de-

vices or turn the devices off. The blood pressure monitor must not be used in connection with a high-frequency surgical unit. During the blood pressure measurement, blood circulation must not be stopped for an unneces-

sarily long time. If the device malfunctions, remove the cuff from the arm. Avoid any mechanical restriction, compression or bending of the cuff line. Do not allow sustained pressure in the cuff or fre-

quent measurements. The resulting restriction of the blood flow may cause injury. Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or therapy, or an arteriovenous (AV) shunt. Do not use the cuff on people who have undergone a mastectomy. CAUTION:

The device should not be used when your arm has been wounded/injured or when a catheter has been inserted. Such use may result in injury. 5 Remove any kind of arm jewelry or the like before taking a measurement. This could cause bruises. Do not place the cuff over heavy clothing (e.g. a jacket or sweater sleeve) as the blood pressure monitor will not be able to take a proper measure-

ment and there is an elevated danger of acquiring hematoma or skin marks during the course of the measurement. In case the cuff does not stop inflating, interrupt the measurement by pressing the start/stop but-

ton and open the cuff at once. weak pulses. In rare cases a mark may persist for a couple of days. Please contact your physician about these specific risks of cuff pressure in your specific case. For hygienic reasons the cuff is intended only for the use by one person. Prolonged over-inflation (cuff pressure exceeds 300 mmHg or maintained above 15 mmHg for long-

er than 3 minutes) of the bladder may cause ec-

chymoma of your arm. Please note that when inflating, the functions of Do not disassemble the unit, it may result in in-

the limb in question may be impaired. juries. When applying the cuff, make sure there are no wrinkles in the cuff. This could cause bruises. Do not exert any kind of pressure on the hose during measurement, e.g. laying your arms or any other object on the hose. This could cause in-

correct measurements. Blood pressure measurements can lead to tempor-

ary marks on the skin at the site of the cuff place-

ment. This is especially the case in high repetition rates, in hypertonic patients and in patients with Do not place the cuff over wounds as this may cause further injury. The accuracy of any blood pressure measurement with this device can be affected by a multitude of causes. Some can be avoided some have to be accepted at the time of measurement. Speak with your physician about possible causes affect-

ing your blood pressure. Do not inflate the cuff unless wrapped around arm. Do not touch the unit, the tube and cuff and/or press any buttons when measurement is in prog-

6 ress, except for stopping the measurement. Doing so may cause incorrect readings. Do not wash the unit in a washing machine, dish washer or tumble dryer. NOTICE:

The blood pressure monitor is made up of preci-

sion electronic components. Accuracy of readings and the instruments service life depend on care-

ful handling. Protect the unit against hard knocks

(e.g. dropping the unit), moisture, water, dirt, dust, chemicals, extreme hot or cold temperatures, ma-

jor temperature fluctuations, direct exposure to sunlight and heat sources which are too close

(e.g. stoves, heating radiators). This may damage the unit. The device must be stored in the speci-

fied ambient conditions. Please see section 10. Care and Maintenance and section 12. Specifi-

cations for details. Do not use any aggressive solvents, cleaning agents, detergents or any other strong chemicals to clean the device. Never immerse and or spill water or any other liquid onto the monitor or any components, otherwise li-

quid will enter it and cause damage. Observe the local regulations for material disposal. Dispose of the device, components and optional accessories according to applicable local regula-

tions. Unlawful disposal may cause environment-

al pollution. Never attempt to repair, open and/or disassemble the unit (including cuff and optional accessory) or adjust it yourself. This may damage the unit and impair the functions. If you need to have the unit repaired, please contact our customer service. Please see warranty for service contact. Before submitting any complaint, first check the batter-

ies and replace them if necessary. Changes or modifications to the device will nullify the user warranty. Do not drop or insert any object into any opening or hose. This may damage the unit. Do not press the buttons with excessive force or with pointed objects. 7 To conserve the batteries, the monitor switches off automatically if no buttons are pressed for one minute. Clean your device and cuff carefully only with a slightly moistened soft cloth and dry it immediately with a soft dry cloth. Do not press. The device is only intended for the purpose de-

scribed in these instructions for use. The manu-

facturer is not liable for damage resulting from im-

proper or careless use. If you are using the unit for the first time, please re-

move the protective film from the display. The monitor can maintain the safety and per-

formance characteristics for a minimum of 10.000 measurements or 3 years. Further documents which include information for the Calibration of the device can be asked at the service address. The device can be tested in case of supposed inaccuracy every two years. Please contact the nearest service address. Cleaning and storing the device and cuff To keep your digital blood pressure monitor in the best condition and protect the unit from damage follow the directions listed below:

When storing the device, make sure that no heavy objects are placed on top of it. Do not fold the cuff and tubing tightly. The cuff tube should not have any sharp kinks and keep it away from sharp edges. If the unit is stored near freezing, allow it to acclim-

ate to room temperature before use. Always store the unit in its storage pouch after use. This unit may not meet its performance specifica-

tions if stored or used outside of the temperature and humidity ranges (see section 12. Specifications). Use the unit consistent with the instruction provided in this manual. Advice on use For consistency, always measure your blood pres-

sure at the same time each day. Always wait at least 5 minutes between measure-

ments to allow the blood circulation in your arm to return to normal. You may need to increase the wait 8 time depending on your individual physiological characteristics. Because of normal physiologic chan-

ges and the many external factors influencing blood pressure, it is unusual to obtain identical blood pres-

sure measurements, even when taken a few minutes apart. Speak with your physician to determine what is affecting your blood pressure and which variation may be seen as normal in your case. When performing multiple measurements on an in-

dividual, wait five minutes between each measure-

ment. Do not take a measurement within 30 minutes of eat-

ing, drinking, smoking or exercising. You should not be physically tired or exhausted while taking meas-

urement. Repeat the measurement if you are unsure of the results. Measurements are for your information only they are no substitute for a medical examination. Discuss the measurements with your doctor and never base any medical decisions on them (e.g. medicines and their administration). Do not use the blood pressure monitor on newborns, pregnant women or patients with pre-eclampsia. Consult your doctor before using the blood pres-

sure monitor during pregnancy. Cardiovascular diseases may lead to incorrect meas-

urements or have a detrimental effect on measure-

ment accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking. For reliable monitoring and reference of blood pres-

sure, keeping long-term records is recommended. To minimize measurement variations due to physic-

al activity, rest at least 5 minutes before measuring your blood pressure (or 15 minutes after strenuous activity). Stress raises blood pressure. Perform measurements in a quiet and relaxed en-

vironment at room temperature. 9 Remove discharged batteries from the product and dispose/recycle in compliance with all applicable laws. Keep batteries away from children and pets. Bat-

teries may be harmful if swallowed. Should a child or pet swallow a battery, seek medical assistance immediately. Battery Handling Safety Precautions Use only the size and type of batteries specified. Be sure to follow the correct polarity when installing the batteries. Reversed batteries may cause dam-

age to the device. Do not mix different types of batteries together (e.g. Alkaline and Carbon-zinc or rechargeable batteries) or old batteries with fresh ones. Always replace bat-

teries as a simultaneous set. If the batteries in the device are depleted or the de-

vice will not be used for a long period of time, re-

move the batteries to prevent damage or injury from possible battery leakage. Do not try to recharge batteries not intended to be recharged; they can overheat and rupture (follow bat-

tery manufacturers directions). Do not dispose of batteries in fire, batteries may ex-

plode or leak. Clean the battery contacts and also those of the de-

vice prior to battery installation. 10 SAFETY INSTRUCTIONS Keep the charger in a dry place (indoor use only). In order to avoid the risk of fire and/or electric shock, the charger must be protected against high humidity and water. Do not connect/disconnect or touch the mains part with wet hands. Only connect the power supply to a mains supply. Do not attempt to open the charger. In case of a defect please return to an autho rised servicecentre. Do not use the power supply in a potentially explosive atmosphere. Do not cover the power supply risk of overheating. Prevent contact with oil, grease etc. Only clean with a dry cloth. SAVE THESE INSTRUCTIONS FOR FUTURE REFERENCE If the instruction manual is damaged or if you no longer have the instruction manual in your posses-

sion, please contact customer service at 1-800-

536-0366 or at info@beurer.com. Dear Customer, Congratulations on your purchase of this Beurer Blood Pressure Monitor. Please read and understand these instructions com-

pletely and carefully before using this product and keep them for later reference. Be sure to make them access-

ible to other users and observe the information they contain. 11 2. Indication for use The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. 3. Important Information Signs and Symbols The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

Attention Note Note on important informat ion Observe the instructions for use Application part, type BF Storage Operating Direct current Permissible storage temperature and humidity Permissible operating temperature and humidity Protect from moisture SN Serial number 4. Package Contents 1 x Blood pressure monitor 1 x Standard cuff (22-36cm) 1 x Storage pouch 4 x 1.5V AA alkaline batteries 1 x Instruction manual 1 x Quick start guide 12 5. Device description Icons in the display:

2 1 3 8 7 6 4 5 11 SYS mmHg DIA mmHg PUL

/min M Bluetooth SET 9 10 1. Arm Cuff 2. Air Tube 3. Air Tube Connector 4. Start/Stop Button 5. +/- Buttons 6. Blood Pressure Classification Scale 7. Air Tube Socket (on side) 8. LCD Display 9. Memory Button 10. SET Button 11. Connection for mains part (model: 3610) 11 10 9 8 1 2 3 4 7 6 5 1. Time and Date 2. Systolic Pressure 3. Diastolic Pressure 4. Pulse Rate 5. Irregular Heartbeat Indicator 6. Battery Level Indicator 7. Memory Space Number/Average ( )/

Morning Reading ( )/ Evening Reading ( ) 8. Deflation Icon 9. Blood Pressure Classification Indicator 10. User memories 11. Bluetooth transfer indicator 13

[LT1]: Model: MD3610 System requirements for the beurer HealthCoach app Bluetooth 4.0, iOS from version 8.0, AndroidTM from version 4.4. List of compatible devices:

6. Preparing for Measurement Installing/Replacing Batteries:

If the batteries are depleted and you cannot power the blood pressure monitor on, you will need to reset the date, time and Bluetooth settings after replacing the batteries. All stored measurements will still be saved. Slide the battery compartment cover in the direction of its arrow to remove. Insert four AA alkaline batteries according to the polarity markings inside the compart-

ment. Reattach battery compartment cover. 14 Operation with the mains part You can also operate this device with a mains part. When doing so, there must not be any batteries in the battery compartment. The mains part can be obtained from specialist retailers or from the service address using order number 071.60. To prevent possible damage to the device, the blood pressure monitor must only be used with the mains part described here. Insert the mains part into the connection provided for this purpose on the right-hand side of the blood pressure moni- tor. The mains part must only be connected to the mains voltage that is specified on the type plate. Then insert the mains plug of the mains part into the mains socket. After using the blood pressure monitor, unplug the mains part from the mains socket first and then disconnect it from the blood pressure monitor. As soon as you unplug the mains part, the blood pressure monitor loses the date and time setting but the saved measurements are retained. 6. The hour flashes on the LCD Display. Set the hour with the +/- Buttons and press the SET Button to confirm. 7. The minutes flash on the LCD Display. Set the min-

utes with the +/- Buttons and press the SET But-

ton to confirm. 8. On will flash in the LCD Display. Use the +/- But-

tons to select whether to activate (On) or deacti-

vate (Of) automatic Bluetooth data transfer to a mobile device. Press the SET Button to confirm and exit. Note that keeping Bluetooth activated will in-

crease battery drain. Setting the hour format, date, time and Bluetooth settings:

If date and time are not set, stored measurements will not have a valid timestamp associated with them. NOTE: Press and hold the +/- Buttons to advance val-

ues rapidly. 1. If

' is not flashing in the LCD Display, press and hold the SET Button for five seconds. 2. Select an hour format (12 or 24 hour display) with the +/- Buttons and press the SET Button to confirm. 3. The year flashes on the LCD Display. Set the year with the +/- Buttons and press the SET Button to confirm. 4. The month fl shes on the LCD Display. Set the month with the +/- Buttons and press the SET But-

ton to confirm. 5. The day flashes on the LCD Display. Set the day with the +/- Buttons and press the SET Button to confirm. NOTE: If the hour format is set to 24h, the day/

month display sequence is reversed. 15 7. Measuring Blood Pressure The blood pressure monitor needs to be at room temperature when measuring. Measurements can be performed on either arm. Positioning the Cuff:

Place the cuff on to the bare left upper arm. The circulation of the arm must not be hindered by tight clothing or similar. The cuff must be placed on the upper arm so that the bottom edge is positioned 0.8 - 1.2 in (2-3 cm) above the elbow and over the artery. The line should point to the centre of the palm. Now tighten the free end of the cuff, but make sure that it is not too tight around the arm and close the hook-and-loop fastener. The cuff should be fastened so that two fingers fit under the cuff. Now insert the cuff line into the connection for the cuff connector. Blood pressure can vary between the right and left arm, which may mean that the measured blood pres-

sure values are different. Always perform the meas-

urement on the same arm. 16 If the values between the two arms are significantly different, please consult your doctor to determine which arm should be used for the measurement. CAUTION:

Only use original Beurer cuffs with this device. The included cuff is suitable for an arm circumference of

(2236 cm). For larger arm circum-ferences, contact customer service to order a lar-ger cuff. Correct Posture:

Rest for at least five minutes before each meas-

urement. Perform the measurement either sitting or lying down. Always make sure that the cuff is level with your heart. 17 To perform a measurement, sit comfortably with your arms and back supported. Do not cross your legs and place your feet flat on the floor. Keep still during the measurement and do not talk. Relax your arm and the palm of your hand. Select a User Memory This unit has four user numbers, each with 30 stor-

age slots each. 1. Press the SET Button and select a user memory from 1 to 4 using the +/- Buttons. 2. Confirm by pressing the Start/Stop Button or just wait for three seconds to set the user number. Performing a Measurement 1. With the cuff attached properly and in a correct posture, press the Start/Stop button . All LCD Display elements will briefly display and three measurement will begin after about seconds. To cancel a measurement at any time, press the Start/ Stop Button . Bluetooth data transfer If the Bluetooth function is activated on the unit, measurement data is transferred to your paired mo-

bile device after measurement. The blood pressure monitor will display the Bluetooth during data transfer. Press the Start/

symbol Stop button again to shut off the blood pressure monitor. 2. As a measurement concludes, air pressure in 3. the Cuff will release. The pulse symbol will display, along with systolic and diastolic pressure. The measurement data will be stored into the selected user memory. and a number from 1 to 7 will appear if the measurement was not performed properly. Refer to the Troubleshooting Guide section for details about specific error message numbers and repeat the measurement. 4. Press the Start/Stop button to shut off the blood pressure monitor. The device will also shut off by itself after about one minute. 5. Wait at least five minutes before taking another measurement. 18 8. Evaluating Results Irregular Heartbeat:

This device can detect irregular heartbeat patterns during measurement and will indicate them by displaying the irregular heartbeat indicator . This may be an indicator for arrhythmia, which is a condition where the heart rhythm is abnormal. These symptoms (omitted or premature heartbeats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress, or lack of sleep. Arrhythmia can only be ascertained through examination by your doctor. Repeat the measurement if the Irregular Heartbeat Indicator displays after a measurement. Rest for at least five minutes between measurements and do not talk or move during measurement. If the icon appears often, contact your doctor, since self-

diagnosis and treatment based solely on the test results may be dan-

gerous. It is vital to follow your doctors instructions Diastole

(in mmHg) Systole

(in mmHg) Blood Pressure Classifications Measurements can be classified and assessed by the table below. However, these standard values are only a general guideline, since individual blood pressure varies in different people and different age groups, etc. Blood pres-

sure value category Setting 3:

severe hypertension Setting 2:

moderate hypertension Setting 1:

mild hypertension regular mon-

itoring by doc-

tor seek medical attention seek medical attention 160 179 100 109 140 159 90 99 Action 180 110 19 Blood pres-

sure value category Systole

(in mmHg) Diastole

(in mmHg) Action High normal 130 139 85 89 Normal Optimal Source: WHO, 1999 120 129 80 84

< 120

< 80 regular mon-

itoring by doc-

tor self-monitoring self-monitoring It is important to consult your doctor regularly for ad-

vice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous. The classification on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the systolic and diastolic values fall into two different categories, the classification indica-

tor on the device always shows the higher category. 9. Displaying and Deleting Meas-

urements User Memory:

Every successful measurement is stored along with its date and time. If there are more than 30 measurements, the oldest measurement is deleted. To select a user memory, press the SET button and then press the +/- buttons until the desired user num-

ber appears on the LCD Display. Average values Press the M button. flashes on the display. The average of all saved meas-

urements in the selected user memory is displayed. Press the M button again. flashes on the display. The average value of the morning measurements for the last sev-

en days is displayed (morning: 5:00 AM 9:00 AM). 20 Press the M button a third time. flashes on the display. The average val-

ue of the evening measurements for the last seven days is displayed (evening:

6:00 PM 8:00 PM). Individual Measured Values:

Press the M button again and the last in-

dividual measurement is displayed. To shut the device off, press the Start/

Stop button . You can exit the menu at any time by pressing the Start/Stop button . Clearing Memory:

When an individual stored measurement is dis-

played, press and hold both the + and - buttons for five seconds. All values in the selected user mem-

ory will be deleted. Copying Stored Measurements using Bluetooth 1. Download and install the HealthCoach app from your devices app store. 2. Ensure Bluetooth is activated on your device and on the blood pressure monitor. 3. Access stored measurements on the unit as de-

scribed in the section Displaying and deleting measurements. Bluetooth data transfer should begin automatically if the two devices are paired properly. The HealthCoach app must be active to allow data transfer. If your smartphone has a protective cover, remove this to ensure that there is no interference during the transfer. We would explicitly draw attention to the fact that the software to hand is not a medical product in accord-

ance with EU Directive 93/42/EEC. The values dis-

played are purely for visualisation purposes and must 21 The data could not be sent via Bluetooth:

In such cases, repeat the measurement. Do not move or speak. If necessary, replace the batteries. In such cases, repeat the measurement, do not move or speak, and if necessary, replace the batteries. 12. Specifications 4 (Cuff size: 22-

not be used as a basis for therapeutic treatments. The software is not part of a diagnostic-medical system. 10. Care and Maintenance Clean the device and cuff with a slightly moistened cloth. Do not use detergents or solvents. Never immerse the device in water or other liquids. When storing the device, make sure no heavy ob-

jects are placed on top of it. Remove the batteries. Ensure the Air Tube does not have any sharp kinks. appears 11. Troubleshooting Guide In the event of errors, the error message on the screen. Error messages may appear if:

It was not possible to correctly record the pulse:

You speak or move during the measurement:

The cuff is fastened too tightly or loosely:

Errors occur during the measurement:

The pump pressure is higher than 300 mmHg:

The batteries are almost empty:

22 Model Measurement Method Measurement Range MD3600B /

MD3610B (Mains Part) Oscillometric, non-invasive blood pressure measurement on the upper arm Cuff pressure 0-300 mmHg, Systolic 50-250 mmHg, Diastolic 30-200 mmHg, Pulse 40-180 beats/minute Display Accuracy Systolic 3 mmHg, Diastolic 3 mmHg, Pulse 5% of the value shown Measurement inaccuracy Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg /

Diastolic 8 mmHg Expected service life Accessories Memory 4 x 30 memory spaces Classification 5 years. Instructions for use, 4 x 1.5V AA batteries, storage pouch Internal supply, IPX0, no AP or APG, continuous operation, application part type BF Dimensions Weight Cuff Size 5.5 in L x 4.0 in W x 2.1 in H

(139 mm L x 103 mm W x 54 mm H) 9.4 oz (267 g) without cuff 22.0 - 36.0cm Operating Range 41 F 104 F (5 C 40 C), Storage Range

-13 F 158 F (-25 C 70 C),

< 93% relative humidity Power Supply 4 x 1.5V AA batteries Battery Life Approx. 200 measurements

(depending on levels of blood pressure and pump pressure/

Bluetooth transfer) Bluetooth

(BLE) Module Operation Frequency 2402-2480MHz. Maximum Transmit Power 0.5dBm The blood pressure monitor uses Bluetooth low energy technology, 2.4 GHz frequency band The serial number can be found on the unit itself or in the battery compartment. Technical information is subject to change without noti-

fication to allow for updates. This device complies with European Standard EN60601-1-2 and is subject to particular precautions 23 15-93% relative humidity (non-

condensing) Data transfer via Bluetooth with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Services ad-

dress or found at the end of the instructions for use. The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN1060-3 (non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-

mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment Part 2 30: Particular requirements for the basic safety and essential performance of automated non-inva-

sive sphygmomanometers). The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If using the device for commer-

cial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address. 13. Mains part Model no. Input Output LXCP12-006060BEH 100 240V, 50 60 Hz 6V DC, 600 mA Supplier Protection SHEN ZHEN Longxc Power supply co.Ltd This device is double insulated and protected against short cirunit andoverload by a primary Polarity of the the DC voltage connec-

tion Double insulated/equipment class 2 Equipment enclosed to protect against contact with live parts, and with parts which can become live (inger, pin, hook test). The operator shall not contact the patient and the output plug of AC mains part simultaneously. Enclosures and Protective Covers 24 FCC Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: 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. MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the users authority to operate the device. IC Regulations/Rglementations de lIC :

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:

1 This device may not cause interference. 2

. operation of the device. This device must accept any interference, including interference that may cause undesired CAN ICES-3(B)/NMB-3(B). The Country Code Selection feature is disabled for products marketed in the US/Canada. cet appareil contient un ou plusieurs metteurs/rcepteur exempts de licence conformes aux normes CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Son exploitation est soumise aux deux conditions suivantes :

1. Cet appareil ne doit pas produire dinterfrences. 2. Cet appareil doit accepter toutes les interfrences quil reoit, y compris celles susceptibles de perturber son fonctionnement. CAN ICES-3(B)/NMB-3(B). La fonction Slection du code pays est dsactive pour les produits disponibles sur les marchs amricain/canadien. Intended use Intended use The blood pressure monitor is intended for the fully automatic, non-invasive measurement of arterial blood pressure and pulse values on the upper arm. Target group It is designed for self-measurement by adults in the home environment and is suitable for users whose upper Appendix I Guidance and manufacturers declaration - electromagnetic emissions The Sphygmomanometer (MD3600B / MD3610B) is intended for use in the electromagnetic environment specified below. The customer or the user of the Sphygmomanometer (MD3600B / MD3610B) should assure that it is used in such an environment. Emissions test RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Compliance Group 1 Class B Class A Compliance Appendix II Guidance and manufacturers declaration - electromagnetic Immunity The Sphygmomanometer (MD3600B / MD3610B) is intended for use in the electromagnetic environment specified below. The customer or the user of the Sphygmomanometer(MD3600B / MD3610B) should assure that it is used in such an environment. Immunity test IEC 60601-1-2 Test level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Compliance level 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power supply lines: 2 kV Power supply lines: 2 kV line(s) to line(s): 1 kV 100 kHz repetition frequency line(s) to line(s): 1 kV 100 kHz repetition frequency 0% 0.5 cycle At 0, 45, 90, 135, 180, 225, 270 and 315 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle 0% 0.5 cycle At 0, 45, 90, 135, 180, 225, 270 and 315 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle Power frequency magnetic field IEC 61000-4-8 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Conduced RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 150KHz to 80MHz:

3Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz 150KHz to 80MHz:

3Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz 10 V/m 80 MHz - 2,7 GHz 80% AM at 1 kHz 10 V/m 80 MHz - 2,7 GHz 80% AM at 1 kHz NOTE UT is the a.c. mians voltage prior to application of the test level. Appendix III Guidance and manufacturers declaration - electromagnetic Immunity The Sphygmomanometer (MD3600B / MD3610B) is intended for use in the electromagnetic environment specified below. The customer or the user of the Sphygmomanometer (MD3600B / MD3610B) should assure that it is used in such an environment. Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communica-

tions equipment) Test Frequency

(MHz) Band

(MHz) Service Modulation Modulation

(W) Distance

(m) IMMUNITY TEST LEVEL(V/m) 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 380-390 TETRA 400 Pulse modulation 430-470 704-787 GMRS 460, FRS 460 LTE Band 13, 17 18Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz 800-960 GSM 800/900, TETRA Pulse modulation 800, iDEN 820, CDMA 18 Hz 850, LTE Band 5 1700-1990 GSM 1800; CDMA Pulse modulation 1900; GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS 217 Hz 2400-2570 Bluetooth, WLAN, Pulse modulation 802.11 b/g/n, RFID 217 Hz 2450, LTE Band 7 1,8 2 0,2 2 2 2 5100-5800 WLAN 802.11 a/n Pulse modulation 0,2 217 Hz 0.3 0.3 0.3 0.3 0.3 0.3 0.3 27 28 9 28 28 28 9 Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal. Grandway Technology (Shenzhen) Limited No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, Guangdong, Peoples Republic of China Shanghai International Trading Corp. GmbH (Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany. 0123 P/N: 83-M3610-SEN01A-R #1108A MADE IN CHINA version number : 1.0 software version: 1.0

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6087418.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case MD3600 Rating Label Digital Automatic Blood Pressure Monitor Model: MD3600B (FCC ID: 2ABAFMD3610B) Measuring range: 30-250mmHg Rating:

6V (4 x 1.5V AA batteries) Grandway Technology (ShenZhen) Limited Shanghai International Trading Corp. GmbH

(Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany. 0123 Background: WHITE Printing:

(1) BLACK

(2) Pantone No. 294c (Blue) Bottom Cabinet INJECTION:

White RAL 9016 Engraving MD3610 Rating Label Digital Automatic Blood Pressure Monitor Model: MD3610B (FCC ID: 2ABAFMD3610B) Measuring range: 30-250mmHg Rating:

6V (4 x 1.5V AA batteries) 600mA Grandway Technology (ShenZhen) Limited Shanghai International Trading Corp. GmbH

(Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany. 0123 Background: WHITE Printing:

(1) BLACK

(2) Pantone No. 294c (Blue) Bottom Cabinet Engraving INJECTION:

Pantone No. BLACK

COMPANY LETTERHEAD Date (August 26, 2022) TUV SUD BABT UNLIMITED TCB Octagon House, Segensworth North, Fareham, Hampshire, PO15 5RL, United Kingdom Confidentiality Request FCC ID: 2ABAFMD3610B Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, (Shenzhen Finicare Co., Ltd) hereby requests permanent confidential treatment of information accompanying this application as outlined below:

Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation Antenna Specification

(Shenzhen Finicare Co., Ltd) also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (180) days:

Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer:

Telephone Number:

Fax Number:

Email:

Eric Wong 852-28516789 852-28516278 eric_wong@grandway.com.hk

To:

TV SD Certification and Testing (China) Co., Ltd. Shenzhen Branch Attention:

From:

Fax No:

Project No.:

Nick Huang Grandway Technology (Shenzhen) Limited 6873021007301, 6873021007601, 6893021002801, 6873021007401, 6893021002701 Subject:

Declaration letter Date: June 25, 2021 Total Page (Cover Included):

1 Quo#:

We: Company Name: Grandway Technology (Shenzhen) Limited Address: No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLES REPUBLIC OF CHINA Officially notify TV SD Certification and Testing (China) Co., Ltd. Shenzhen Branch that the <<

MD3600B >> have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction, with <<

Digital Automatic Blood Pressure Monitor >>, << MD3610B >>. The difference lies only in < model name, DC input port and the color of appearance > of the different models. The differences details are listed below. Model MD3600B MD3610B Dimension (mm) 103*139*54 Same Construction Without AC-DC function With AC-DC function Power supply 4x1.5Vdc AA batteries 4x1.5Vdc AA batteries/

6V DC, 600mA AC-DC adaptor file: declaration letter-template Page 1 of 2

<< Additional model >>: MD3600B

<< Main Model >>: MD3610B

<<Product Name >>: Digital Automatic Blood Pressure Monitor Applicant:

Nov-8, 2021 ___________ __________________________________________

(Date) (Applicants authorized signature and company Chop) file: declaration letter-template Page 2 of 2