FCC ID: OU9SBM69-B01 Blood Pressure Monitor

PM x 04.07.2019 LARO Item No. / No. de artculo: 659.59 UPPER ARM BLOOD PRESSURE MONITOR /

TENSIMETRO DE BRAZO UPPER ARM BLOOD PRESSURE MONITOR Instructions for use and safety notes TENSIMETRO DE BRAZO Notas sobre el uso y la seguridad IAN 326870 6870_silv_Blutdruckmessgeraet_Cover_US.indd 2 04.07.19 09:2 US-EN US-ES Instructions for use and safety notes Notas sobre el uso y la seguridad Page 3 Pgina 51 6870_silv_Blutdruckmessgeraet_Cover_US.indd 3 04.07.19 09:2 6870_silv_Blutdruckmessgeraet_Cover_US.indd 4 04.07.19 09:2 PM x 04.07.2019 LARO Signs and symbols ...................................................Page Description of signal words ...............................Page Customer service .......................................................Page List of pictograms used .........................................Page 5 5 6 6 Introduction ..................................................................Page 7 8 Intended use ....................................................................Page 8 Improper use ....................................................................Page Parts description...............................................................Page 9 Scope of delivery .............................................................Page 11 Technical data .................................................................Page 11 Important safety notes ..........................................Page 14 Safety warnings for batteries ..........................................Page 27 Initial use ................................................................ Page 30 Inserting / Replacing batteries .........................................Page 30 App / web version of HealthForYou ...........................Page 31 Configuring the date / time / Bluetooth ........................Page 31 Measuring blood pressure .................................Page 33 Attaching the cuff .............................................................Page 33 Adopting the correct posture ..........................................Page 36 Selecting a memory .........................................................Page 37 Carrying out the blood pressure measurement .............Page 38 Transferring measurements via Bluetooth..............................................................Page 39 Evaluating measurements ..................................Page 40 Risk indicator ....................................................................Page 41 US-EN 3 6870_silv_Blutdruckmessgeraet_Content_US.indd 3 04.07.19 09:1 Saving, requesting and deleting measurements Page ......................................................................................43 Cleaning and care .....................................................Page 44 Storage ............................................................................Page 45 Troubleshooting .........................................................Page 46 Disposal ...........................................................................Page 47 Three year limited warranty .............................Page 47 4 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 4 04.07.19 09:1 Signs and symbols The following signs are used in the safety section and in these instructions for use. CAREFULLY READ THIS ENTIRE MANUAL, THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY NOTES AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO ENSURE CORRECT PRODUCT USE. The following terms indicate safety and prop-

erty damage messages, and the hazard level. DESCRIPTION OF SIGNAL WORDS WARNING indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. NOTICE indicates information considered important, but not hazard related (e.g. messages related to property damage). US-EN 5 6870_silv_Blutdruckmessgeraet_Content_US.indd 5 04.07.19 09:1 CUSTOMER SERVICE Call customer service at 1 (844) 543-5872 Visit the Website Customer Service Platform at www.lidl.com/contact-us Visit a LIDL store for further assistance. IAN 326870 Please have your IAN number ready. List of pictograms used Safety note related to possible damage to the de-

vice / components Safety notes Instructions Observe instructions for use Direct current Permissable storage and transport temperature and humidity Storage /

Transport 6 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 6 04.07.19 09:1 Operating Permissible operating temperature and humidity Permissible storage, transport and operating air pressure Applied part, type BF Serial number IP21 Device protected against foreign matter 0,49 inch /

12.5 mm and against water falling vertically Upper Arm Blood Pressure Monitor Introduction Congratulations on your purchase. You have se-

lected a quality product. The instructions for use are a part of the product. They contain important information about the safety, use and disposal of the prod-

uct. Before using the product, please learn about all the safety information and usage instructions. Only use the product as described and for the specied applications. If you lend the product to someone else, please also give all the instructions. US-EN 7 6870_silv_Blutdruckmessgeraet_Content_US.indd 7 04.07.19 09:1 Intended use This upper-arm blood pressure monitor is intended to measure and monitor the arterial blood pressure values and the heart rates of adults with an arm circumference of 8.7 in to 16.5 in

(22 cm to 42 cm), in a non-invasive way. Using this device, you can quickly and easily measure your blood pressure, save the measurements and display the progression and average of these measurements. You are warned in cases of pre-existing cardiac arrhythmia. The values determined are classied and evaluated graphically. Any use other than previously mentioned or any product modication is prohibited and may result in injuries and / or product damage. The manufacturer assumes no liability for damage arising out of improper use. The product is only intended for use in private environments (at home). Improper use Failure to observe the following warnings may result in death or serious injuries. Do not use this product on newborns and preeclampsia patients. We recommend consulting your doctor before using the product if you are pregnant. The device is not suitable for use by patients with implanted electrical devices such as pacemakers or debrillators. The measurements determined by you are only intended for your information - they do not replace a medical ex-

amination. Discuss the measurements with your doctor. 8 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 8 04.07.19 09:1 Do not self-diagnose or self-treat based on the measure-

ment results without consulting your attending physician. Do not start new medication without consulting a doctor and do not modify the type and / or dosage of current medications. The product may not be used in conjunction with a high-frequency surgical unit. Failure to observe the following warnings may result in injuries or property damage. Using the blood pressure monitor outside the domestic environment or under the inuence of movement (e.g. whilst riding in cars, ambulances or helicopters as well as whilst practising physical activities such as sport) can impact the accuracy of the measurement and lead to measurement errors. Parts description 1 Cu 2 Cu tubing 3 Cu plug 4 Display 5 Memory button M 6 Settings button SET 7 Function button -/+

8 START/STOP button 9 Risk indicator US-EN 9 6870_silv_Blutdruckmessgeraet_Content_US.indd 9 04.07.19 09:1 10 Connection for cu plug 11 Battery compartment 1 2 3 4 10 9 8 5 6 11 7 Display indicators 12 Time and date 13 Systolic pressure 14 Diastolic pressure 15 Pulse value determined 16 Symbol for cardiac arrhythmia 17 Symbol for replace battery 18 Memory display: Average value (A), morning (AM), Symbol for pulse evening (PM), number of the memory space 19 Risk indicator 20 Release air 21 User memory 22 Symbol for Bluetooth transfer 10 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 10 04.07.19 09:1 12 13 14 22 21 20 19 18 17 16 15 Scope of delivery 1 Upper arm blood pressure monitor 1 Upper arm cu (Material no. 164.137) with cu tubing 4 Batteries 1.5 V type AAA LR03 1 Instructions for use 1 Quick start guide Technical data Type:

Measuring method:

SBM 69 Oscillometric, non-invasive blood pres-

sure measurement on the upper arm Measurement range: Cu pressure 0299 mmHg, systolic 60230 mmHg, US-EN 11 6870_silv_Blutdruckmessgeraet_Content_US.indd 11 04.07.19 09:1 Display accuracy:

Measurement uncertainty:

Memory:

Dimensions:

Cu:

Weight:

diastolic 40130 mmHg, pulse 40199 beats per minute systolic 3 mmHg, diastolic 3 mmHg, pulse 5 % of the displayed value max. permissible standard deviation according to clinical testing: systolic 8 mmHg / diastolic 8 mmHg 4 x 30 memory spaces L 5.44 in x W 3.944 in x H 2.01 in /

L 138,2 mm x W 100,2 mm x H 51,0 mm suitable for an arm circumference between 8.7 in / 22 cm and 16.5 in / 42 cm 0.87 lb / 395 g (with cu, without batteries) Permissible operating conditions: 41 F to 104 F / +5 C to +40 C, 15 % to 90 % relative humidity

(non-condensing), 7001060 hPa ambient pressure

- 4 F to 140 F / -20 C to +60 C, 93 % relative humidity 4 x 1.5 V AAA batteries Permissible storage conditions:

Power supply:

12 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 12 04.07.19 09:1 Product expected lifespan:

Battery life:

Components:

Classication:

5 years 225 measurements, depending on blood pressure level and ination pressure / Bluetooth transfer instructions for use, 4 x 1.5 V AAA LR03 batteries, storage pouch Internal supply, IP21, no AP or APG, continuous operation, applied part Type BF Data transfer via Bluetooth wireless technology: The product uses Bluetooth low energy technology, frequency band 2.4022.480 GHz, maximum transmission power radiated in the frequency band < 4 dBm, compatible with Bluetooth 4.0 smart phones / tablets For a list of compatible smartphones, information about the HealthForYou app and software, as well as further details about the devices, please visit:

www.healthforyou.lidl System requirements of the HealthForYou web version:

- MS Internet Explorer

- MS Edge US-EN 13 6870_silv_Blutdruckmessgeraet_Content_US.indd 13 04.07.19 09:1

- Mozilla Firefox

- Google Chrome

- Apple Safari

(in the respective updated version) System requirements of the HealthForYou app iOS from Version 10.0, AndroidTM from Version 5.0, Bluetooth 4.0. Technical specications subject to change without notice due to updates. Important safety notes Failure to observe the following warnings may result in death or serious injuries. Consult your physician or pharmacist before starting to measure your blood pressure. Read and understand all instructions and warnings before using this device. Like any oscillometric blood pressure measurement devices, certain medical conditions can aect the measurement accuracy, among others:

disorder of the cardiac rhythm very low blood pressure patients in shock patients with very low blood perfusion diabetes 14 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 14 04.07.19 09:1 vessel anomalities people with electrical implants, such as a cardiac pacemaker women who are pregnant. Due to their condition the oscillometric measurement 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 provide a medical diagnosis. Measurements results are for refer-

ence 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 appropriate medication and dos-

age thereof. Follow the instructions of your physician or licensed healthcare provider. If you have or suspect that you have a medical problem, promptly consult your physician. If you have an emergency please call 911 immediately. Only a physician or a trained health care professional who is familiar with your medical history is able to ac-

curately interpret your blood pressure measurements. Consult your physician before starting blood pressure monitoring. This product is not intended to serve as a substitute for the advice of a physician or medical professional. This product is not intended to substitute for regular medical checkups. Contact your physician for specic informa-

tion about your blood pressure. US-EN 15 6870_silv_Blutdruckmessgeraet_Content_US.indd 15 04.07.19 09:1 Please note that technically related measuring tolerances are possible. Please see section Technical data for details. Note: A single measurement does not provide an ac-

curate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency. Any cu related blood pressure measurement in high repetition rates, can lead to severe measurement side eects, 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 specic risks of cu pressure in your specic case. The irregular heartbeat function does not replace a cardiac examination, but may help to detect potential 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 di-

agnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician. The JNC chart is not intended to replace a medical di-

agnosis. This chart is only a reference for dierent clas-

sications of blood pressure. 16 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 16 04.07.19 09:1 If you notice abnormal or suspicious variations in blood pressure measurements, consult your physician immedi-

ately. Women who underwent a breast or axillar lymph node removal operation should consult a physician or licensed healthcare provider before starting blood pressure measurements. Prior to use, you have to ensure that the blood pressure 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-commer-

cial, 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 oce, or any other health care facility. The unit must be used in accordance to the specied ambient conditions, otherwise the accuracy of readings might be aected. See section Cleaning and care and section Technical data for details. Do not wrap the cu around body parts other than your arm. Misuse represents a risk to your health. Please do not share the cu with other persons, to avoid cross infection. Use this monitor only on humans. This product is not intended for use by or on children, toddlers and infants or on persons who cannot express their consent, e.g. persons with mental disorders or the like. Consult your physician for alternative methods of measuring a childs blood pressure. US-EN 17 6870_silv_Blutdruckmessgeraet_Content_US.indd 17 04.07.19 09:1 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 children and can cause suocation. Remove all packaging ma-

terials 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 CHILDREN OR THOSE WHO REQUIRE CLOSE SUPERVISION UNAT-

TENDED WITH THIS DEVICE. The tubing presents a strangulation hazard. Keep this product away from children and those who require close supervision, e.g. people with mental disorders. NEVER LEAVE CHILDREN OR THOSE WHO REQUIRE CLOSE SUPERVISION UNATTENDED WITH THIS DEVICE. Do not drape tube around neck. This presents a stran-

gulation hazard. People with disabilities, activity limitations, or who are physically frail, should be assisted by another person when using this unit. Proper cu size is important for accurate measurements. Only use the device on adults who have the right upper arm circumference for this instrument. See section Technical data for suitable upper arm circumferences. Do not use any cus, tubes, parts and accessories other than those explicitly recommended by the manufacturer for use with this product. Parts and accessories not 18 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 18 04.07.19 09:1 approved for use with the device may cause damage to your health and to the product. Electromagnetic interference: Avoid strong electrical or electromagnetic elds in the direct vicinity of the device

(e.g. mobile telephones, microwave ovens) while it is in operation, as inaccurate measurements may result. To prevent such interference, use the unit at a sucient dis-

tance from such devices or turn the devices o. Do not measure your blood pressure while operating a vehicle or in any situation which requires your full atten-

tion. During the blood pressure measurement, blood circula-

tion must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cu from the arm. Avoid any mechanical restriction, compression or bend-

ing of the cu line. Do not allow sustained pressure in the cu or frequent measurements. The resulting restriction of the blood ow may cause injury. Ensure that the cu 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 cu on people who have undergone a mastectomy. This device is not intended to be used by persons with limited physical, sensory or mental abilities or lacking experience and / or knowledge unless supervised or instructed on its use by an person responsible for their US-EN 19 6870_silv_Blutdruckmessgeraet_Content_US.indd 19 04.07.19 09:1 safety. Children should be supervised to ensure they do not play with the device. Cardiovascular system diseases may result in incorrect measurements and/or impairments to the devices mea-

surement accuracy. This is also the case when it comes to low blood pressure, diabetes, circulatory problems and dysrhythmia, as well as chills and shaking. Ensure that the cu is not placed on an arm whose arteries or veins are undergoing medical treatment, i.e. intravascular access or intravascular therapy or an arteriovenous (A-V) shunt. Only place the cu on the upper arm. Do not place the cu on other body parts. Attention: The device may only be used in conjunction with the original cu provided. Failure to observe the following warnings may result in injuries or property damage. The device should not be used when your arm has been wounded/injuried or when a catheter has been inserted. Such use may result in injury. Remove any kind of arm jewelry or the like before taking a measurement. This could cause bruises. Do not place the cu over heavy clothing (e.g. a jacket or sweater sleeve) as the blood pressure monitor will not be able to take a proper measurement and there is an elevated danger of acquiring hematoma or skin marks during the course of the measurement. 20 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 20 04.07.19 09:1 In case the cu does not stop inating, interrupt the mea-

surement by pressing the start/stop button and open the cu at once. Do not disassemble the unit, it may result in injuries. When applying the cu, make sure there are no wrinkles in the cu. 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 incorrect measurements. Blood pressure measurements can lead to temporary marks on the skin at the site of the cu placement. This is especially the case in high repetition rates, in hypertonic patients and in patients with weak pulses. In rare cases a mark may persist for a couple of days. Please contact your physician about these specic risks of cu pressure in your specic case. For hygienic reasons the cu is intended only for the use by one person. Prolonged over-ination (cu pressure exceeds 300 mmHg or maintained above 15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your arm. Please note that when inating, the functions of the limb in question may be impaired. Do not place the cu over wounds as this may cause further injury. The accuracy of any blood pressure measurement with this device can be aected 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 aecting your blood pressure. US-EN 21 6870_silv_Blutdruckmessgeraet_Content_US.indd 21 04.07.19 09:1 Do not inate the cu unless wrapped around arm. Do not touch the unit, the tube and cu and/or press any buttons when measurement is in progress, except for stopping the measurement. Doing so may cause incorrect readings. Blood circulation should not be restricted by the blood pressure measurement for an unnecessary amount of time. Remove the cu from the arm if the device mal-

functions. Avoid sustained pressure to the cu, as well as frequent measurements. The resulting curtailing of the blood ow can lead to injuries. Potential damage to the device! The blood pres-

sure monitor is made up of precision components and electronic components. The accuracy of the measurements and the service life of the device depend on the device being used with a due amount of care:

The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instruments service life depend on careful handling. Protect the unit against hard knocks (e.g. dropping the unit), moisture, water, dirt, dust, chemicals, extreme hot or cold temperatures, major temperature uctuations, direct exposure to sunlight and heat sources which are too close (e.g. stoves, heating radiators). This may dam-

age the unit. The device must be stored in the specied 22 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 22 04.07.19 09:1 ambient conditions. Please see section Cleaning and care and section Technical data 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 liquid will enter it and cause damage. Do not wash the unit in a washing machine, dish washer or tumble dryer. Observe the local regulations for material disposal. Dispose of the device, components and optional acces-

sories according to applicable local regulations. Unlaw-

ful disposal may cause environmental pollution. Never attempt to repair, open and/or disassemble the unit (including cu and optional accessory) or adjust it yourself. This may damage the unit and impair the func-

tions. If you need to have the unit repaired, please con-

tact our customer service. Please see warranty for service contact. Before submitting any complaint, rst check the batteries and replace them if necessary. Changes or modications 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. To conserve the batteries, the monitor switches o auto-

matically if no buttons are pressed for one minute. US-EN 23 6870_silv_Blutdruckmessgeraet_Content_US.indd 23 04.07.19 09:1 The device is only intended for the purpose described in these instructions for use. The manufacturer is not lia-

ble for damage resulting from improper or careless use. If you are using the unit for the rst time, please remove the protective lm from the display. The monitor can maintain the safety and performance characteristics for a minimum of 10.000 measure ments 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 inaccu-

racy every two years. Please contact the nearest service address. To keep your digital blood pressure monitor in the best condition and protect the unit from damage follow the directions listed below:

Clean your device and cu carefully only with a slightly moistened soft cloth and dry it immediately with a soft dry cloth. Do not press. When storing the device, make sure that no heavy ob-

jects are placed on top of it. Do not fold the cu and tubing tightly. The cu tube should not have any sharp kinks and keep it away from sharp edges. If the unit is stored near freezing, allow it to acclimate to room temperature before use. Always store the unit in its storage bag after use. 24 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 24 04.07.19 09:1

 Consult the dealer or an experienced radio /

TV technician for help. Advice on use For consistency, always measure your blood pressure at the same time each day. Always wait at least 5 minutes before starting the initial measurement to allow the blood circulation in your arm to return to normal. You may need to increase the wait time depending on your individual physiological characteris-

tics. Because of normal physiologic changes and the many external factorVLQXHQFLQJEORRGSressure, it is unusual to obtain identical blood pressure measure-

ments, even when taken a few minutes apart. Speak with your physician to deterPLQHZKDWLVDHFWLQJyour blood pressure and which variation may be seen as nor-

mal in your case. When performing multiple measurements on an individ-

ual, wait at least one minute between each measure-

ment. Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising. You should not be physi-

cally tired or exhausted while taking measurement. 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. Con-

sult your doctor before using the blood pressure moni-

tor during pregnancy. 26 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 26 04.07.19 09:1 Cardiovascular diseases may lead to incorrect mea-

surements or have a detrLPHQWDOHHFWRQPHDVXrement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhyth-

mias 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 physical 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 environ-

ment at room temperature. i. The device requires no calibration. ii. No modification of this equipment is allowed. iii. The user must check that the equipment functions safely and see that it is in proper working condition before being used. iv. The manufacturer does not require such preventive inspections by other persons. v. Manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL in parts repair. vi. Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase vii. Pressurization of the CUFF can temporarily cause loss of function of simultaneously used monitoring ME EQUIPMENT on the same limb Safety warnings for batteries When used correctly, cells and batteries provide a safe and dependable source of portable power. However, if they are misused or abused, this may result in leakage, burQVre, or explosion. Store batteries in a dry place at room temperature. Batteries are sensitive to high and low temperatures. Such thermal exposure may lead to leakDJHre, or explosion. US-EN 27 6870_silv_Blutdruckmessgeraet_Content_US.indd 27 04.07.19 09:1 Keep cells and batteries out of reach of children, espe-

cially small batteries. Ingestion may lead to choking or acute and serious personal injury. Keep cells or batteries clean and dry both during use and storage. Wipe metal terminals with a soft, dry cloth if they become dirty. Immediately seek medical attention if a cell or battery has been swallowed. Also, contact your local poison control center. In the event that the electrolyte comes into contact with the skin or eyes, immediately ush with fresh water for at least 15 minutes and seek medical attention. Store unused batteries in their original packaging or in safe place and away from metal objects that may short-circuit them. Exercise care in handling batteries in order to prevent shorting with conducting materials, such as rings, coins, bracelets, and keys. The battery or the conductor can overheat and cause burns, leakage, re, or explosion. Clean the battery contacts and also those of the product prior to battery installation. Keep the contacts clean. Remove batteries from the product that will not be used for an extended period of time (months or longer). Remove discharged batteries from product promptly to avoid possible damage from leakage. Choose the proper battery for the intended application. Always take care to correctly insert batteries observing

(+) and (-) polarity marks on the battery and the product for which it is intended. Proper polarity must be observed to avoid damage to either product or batteries. 28 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 28 04.07.19 09:1 Always replace the whole set of batteries at one time, taking care not to mix old and new ones, or batteries of dierent types, capacities, or manufacturers. Never heat batteries in order to revive them. Never charge a battery unless the battery label speci-

cally states the battery is rechargeable. Charging a non-rechargeable battery, may result in leakage, re, or explosion. Do not open or mutilate a battery or cell. Electrolyte from the cell is corrosive and can cause damage to the eyes or skin. The cell contents can also be hazardous if in-

gested. Do not drop or subject the cell or battery to strong me-

chanical shock. Batteries should not be disassembled, crushed, punc-

tured, or otherwise mutilated. Such abuses may result in leakage, re, or explosion. Do not dispose of the battery in a re. Failure to observe this precaution may result in an explosion. Dispose of batteries properly and in accordance with government regulations. SAVE THESE INSTRUCTIONS US-EN 29 6870_silv_Blutdruckmessgeraet_Content_US.indd 29 04.07.19 09:1 Initial use Verify the parts listed in the scope of delivery are complete. Remove all packaging material. Inserting / Replacing batteries Slide the battery cover o the battery compartment 11 Insert the four type 1.5 V AAA (Alkaline type LR03) batteries (with the correct polarity) into the device. Please note the marking inside the battery compartment. 11 Carefully close the battery cover on the battery com-

partment 11 . Do not use rechargeable batteries. Note: If the battery indicator 17 is displayed continu-

ously, measurement is not possible and you must replace all of the batteries with new batteries. As soon as the batteries have been removed from the device, the date and time will be reset. 30 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 30 04.07.19 09:1 All display elements will be displayed briey and 12h will ash on the display. Congure the date, time and Bluetooth (see Conguring date / time / Bluetooth). App / web version of HealthForYou Download the free app HealthForYou from the Apple App Store and Google Play. Follow the installation instructions on the screen. Alternatively, you can also visit the website www.healthforyou.lidl. Here you will be able to enter measurements and nd guidance for assessment. Conguring the date /

time / Bluetooth Congure the date, hour format and time. It is only in this way that you will be able to correctly save these measurements with the date and time and request them later on. The settings menu can be accessed in two dierent ways:

US-EN 31 6870_silv_Blutdruckmessgeraet_Content_US.indd 31 04.07.19 09:1 Before rst use and after every battery change:

When you insert batteries into the device, you will auto-

matically arrive at the relevant menu. If batteries have already been inserted:

On the switched-o device, hold the settings button SET 6 pressed for 5 seconds. Now proceed as follows:

The time format will ash. Use the function buttons -/+ 7 to set the format to 12-hour or 24-hour. Press the SET button 6 to conrm. The year will ash. Use the function buttons - / + 7 to set the year. Press the SET button 6 to conrm. The month will ash. Use the function buttons - / + 7 to set the month. Press the SET button 6 to conrm. Congure the day, hour and minute consecutively as described above. Press the SET 6 button to conrm each entry. The Bluetooth symbol will be shown on the display. On or O will ash at the same time. Using the function buttons - / +, choose whether you want to activate (On ashes) or deactivate (O ashes) Bluetooth data transfer. Press the SET button 6 to conrm. If Bluetooth is activated (On) data transfer will begin automatically after the measurement has been taken. Note: The battery life is reduced by transfer via Blue-

tooth. 32 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 32 04.07.19 09:1 Measuring blood pressure Note: To guarantee that you will be able to compare values adequately, always measure your blood pressure at the same time of day. You should not eat, drink, smoke or be physically active in the 30 minutes before each measurement. Before taking the rst blood pressure measurement, always rest for 5 minutes!

Furthermore, if you wish to take multiple measurements one after the other, always wait at least 1 minute between each measurement. Repeat the measurement process if the measured values seem incorrect. Bring the device to room temperature before the mea-

surement. Attaching the cu The device may only be used in conjunction with the origi-

nal cu provided. The cu is suitable for an upper arm circumference of between 8.7 in and 16.5 in / 22 cm and 42 cm. Place the cu 1 on a bare upper arm. The blood ow of the arm should not be constricted by clothing etc. which is too tight. US-EN 33 6870_silv_Blutdruckmessgeraet_Content_US.indd 33 04.07.19 09:1 The cu 1 should be placed on the upper arm in such a way that the lower edge lies 0.79 in to 1.19 in /

2 cm3 cm over the crook of the arm and the artery. The cu tubing 2 points to the centre of the palm. Place the free end of the cu 1 closely, but not too tightly, around the arm and close the Velcro strip. The cu 1 should not be too tight. Check that two ngers can still t beneath the cu 1 . 34 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 34 04.07.19 09:1 This cu is suitable for you if, after putting it on, the index marker () falls within the OK area. Now insert the cu tubing 2 with the cu plug 3 into the connector. US-EN 35 6870_silv_Blutdruckmessgeraet_Content_US.indd 35 04.07.19 09:1 Adopting the correct posture Note: Stay still during the measurement process and do not talk to prevent the measurement result from being falsied. You can carry out the measurement while sitting or lying down. Always ensure that the cu 1 is at the same level as the heart. 36 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 36 04.07.19 09:1 Sit comfortably for the blood pressure measurement. Recline your back and arms. Do not cross your legs. Put your feet at on the ground. In order not to falsify the measurement result, it is im-

portant that you stay still and do not talk. Selecting a memory

... Press the SET button 6 . Select the desired user mem-

ory 21 by pressing the function buttons -/+ 7 . You have 4 memories with 30 memory spaces for saving the measurement results of 4 dierent people separately. Conrm your choice using the START / STOP button 8 or wait 3 seconds. Your choice will then be saved automatically. US-EN 37 6870_silv_Blutdruckmessgeraet_Content_US.indd 37 04.07.19 09:1 Carrying out the blood pressure measurement Place the cu on your arm as previously described and assume the position in which you wish to carry out the measurement. Switch on the blood pressure monitor using the START /

STOP button 8 . After the full-screen display, the last measurement result saved will be displayed. If no measurement has been saved, the de-

vice will display the value of 0. After 5 seconds, the blood pressure monitor will begin with the measurement by pumping up the cu. The measurement is taken while the cu is being pumped up. As soon as a pulse has been detected, the pulse symbol will be displayed. After this, the cu air pressure will be released again. The measurement results for systolic pressure, diastolic pres-

sure and pulse will be displayed. You can stop the measurement at any time by pressing the START / STOP button If the measurement has not been carried out correctly, Er_ will be displayed (see Troubleshooting also). Repeat the measurement process in the event that this happens. The measurement result will be saved automatically. If you have activated Bluetooth data transfer, the data will be transferred. The blood pressure monitor displays the symbol for Bluetooth transfer during transfer. Switch the blood pressure monitor o by pressing the START /

STOP button once more. 8 . 38 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 38 04.07.19 09:1 To power down press the START / STOP button 8 . Note: The device switches o automatically after one minute if no button has been pressed. Wait for at least one minute before taking another measurement!

Transferring measurements via Bluetooth You have the option of transferring the measured values and values saved on your device to your smartphone using Bluetooth low energy technology. Activate Bluetooth in your smartphone settings and open the HealthForYou app. Note: The HealthForYou app must be open for trans-

fer to occur. Add SBM69 in the app. When connecting for the rst time, a randomly generated six-digit PIN code will be displayed on the device over two lines. At the same time, an entry eld will appear on your smartphone where you should enter this six digit code. When you have entered it correctly, the device is connected with your smartphone and you can begin to transfer your measurement values. The displayed values are intended merely as a visualisation and may not be used as the basis for therapeutic measures. The software is not part of a diag-

nostic medical system. US-EN 39 6870_silv_Blutdruckmessgeraet_Content_US.indd 39 04.07.19 09:1 Note: During data transfer, button functions cannot be executed. To transfer measurements to your smartphone via Bluetooth proceed as follows:

Manual transfer Go to save mode (see Saving, requesting and deleting measurements). As soon as the average value of all mea-

surements is displayed, a Bluetooth connection will auto-

matically be established. The data will be transferred and the Bluetooth symbol will be shown on the display. Switch the blood pressure monitor o by pressing the START / STOP button 8 . Automatic transfer If you forget to switch o the blood pressure monitor, it will automatically switch o after one minute. In this case, the value will be saved in the selected user memory and the data will be transferred if Bluetooth data transfer has been activated. The Bluetooth symbol will be shown on the display during transfer. Evaluating measurements Cardiac arrhythmia This device can identify any potential cardiac arrhythmia disorders and, if necessary, indicates this after the measure-

ment process with the symbol

. This can be an indicator for arrhythmia. 40 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 40 04.07.19 09:1 Arrhythmia is an illness in which the heart rhythm is abnor-

mal due to errors in the bioelectric system, which controls the heartbeat. The symptoms (skipped or premature heart-

beats, slow or rapid pulse) can stem from heart conditions, age, physical predispositions, an excess of luxury foods, stress or a lack of sleep. Arrhythmia can only be diagnosed by a doctor after a physical examination. Repeat the measurement process if the symbol shown on the display after the measurement. Please make sure that you rest for a minute before the measurement and do not talk or move during it. is If the symbol is displayed repeat-

edly, contact your doctor. Self-diagnosis and self-treat-

ment on the basis of measurement results can be dan-

gerous. Follow your doctors instructions. Risk indicator In accordance with the guidelines / denitions provided by the Joint National Committee (JNC) and the latest ndings, the measurement results can be classied and evaluated ac-

cording to the following table:

US-EN 41 6870_silv_Blutdruckmessgeraet_Content_US.indd 41 04.07.19 09:1 Stages of blood pressure levels Stage 2 Hypertension Stage 1 Hypertension Pre-hyperten-

sion Systolic

(mmHg) Diastole

(mmHg) Color Measure

>=180

>=110 Red 160179 100109 Red 140159 9099 Red Seek medical advice Seek medical advice Have it checked regularly by doctor 130139 8589 Yellow Have it 120129 8084 Green Normal

<120

<80 Green checked regularly by doctor Check it yourself Check it yourself Source: U.S. Department of Health and Human Service, JNC7

(2004), adapted The JNC chart is not intended to replace a medical diagnosis. This chart is only a reference for dierent classications of blood pressure. Note: These standard values merely serve as a general guideline as blood pressure deviates depending on the individual, dierent age groups, etc. 42 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 42 04.07.19 09:1 It is important that you consult your doctor at regular intervals. Your doctor will give you your particular values for normal blood pressure as well as the value for when your blood pressure is classied as dangerous. The bar chart on the display and the scale on the device state which range the blood pressure measured is in. If the values for systolic and diastolic pressure are in two dierent JNC ranges (e.g. systolic in the Stage 1 Hyperten-

sion range and diastolic pressure in the normal range) the graphic JNC classication on the unit indicates the higher range (Stage 1 Hypertension in the example described). Saving, requesting and deleting measurements The results of each successful measurement are saved together with the date and time. If there are over 30 measurement values, the oldest measurement value will be overwritten. Press the SET button 6 . Press the function buttons -/+

... 7 to select the desired user memory

. Conrm your choice using the START / STOP button 8 . Press the memory button M 5 to display the average value A of all saved measurements pertaining to the user memory. Press the memory button M 5 again to display the average value of the last 7 days for the morning measurement. (Morning: 5.00 am 9.00 am, display AM). Press the memory button M 5 again to display the average value of the last 7 days for the evening measurement. (Evening: 6 pm 8 pm, display US-EN 43 6870_silv_Blutdruckmessgeraet_Content_US.indd 43 04.07.19 09:1 PM). By pressing the memory button M again, the last individual measurement will be displayed with the date and time. Press the START / STOP button device. Note: The device switches o automatically after one minute when no button has been pressed. 8 to switch o the Deleting data To delete the memory of the selected user, press the memory button M 5 when the device is switched o. The average value of all measurements will appear on the display. Next to this, A and the Bluetooth trans-

fer symbol 22 will ash. Keep the function buttons - / + 7 pressed simultaneously for 5 seconds. After successful deletion, CL 00 will appear in the display. The data has been deleted. Cleaning and care Possible property damage! Never hold the product under water as liquid could enter the product and damage it. Clean the device and cu 1 carefully using a slightly damp cloth. Do not use cleaners or solvents. 44 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 44 04.07.19 09:1 Storage Possible property damage! Do not place any heavy objects on the device and cu 1 . If the product will not be used for more than one month, remove both batteries from the device to prevent possible battery leakage. Do not kink the cu tubing 2 . Store the product in a dry location (relative humidity 93 %). High humidity can shorten the service life or damage the product. Store the product in a location with ambient temperatures between - 4 F and 140 F / -20 C and +60 C. US-EN 45 6870_silv_Blutdruckmessgeraet_Content_US.indd 45 04.07.19 09:1 Troubleshooting Problem Solution The pulse cannot be measured correctly. You have been talking or moving during the measurement process. The cu was attached too tightly or too loo-

sely. An error occurred du-

ring the measurement process. The pump-up pressure is higher than 300 mmHg or the blood pressure mea-

surement falls outside of the measuring range. The batteries are almost dead. Data cannot be sent via Bluetooth. A device error has occurred. Repeat the measurement process. Be sure not to move or talk. Reinsert the batteries or replace them with new batteries. Activate Bluetooth on your smartphone and start the "HealthForYou" app. Repeat the measurement process. Be sure not to move or talk. Trouble-

shooting Er1 Er2 Er3 Er4 Er5 Er6 Er7 Er8 46 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 46 04.07.19 09:1 Disposal Observe the local regulations for material disposal. Dispose of the device in accordance with local regulations. If you have any questions, please contact the local authorities re-

sponsible for waste disposal. Three year limited warranty What does this warranty cover?

The warranty covers:

Damage, breakage or inoperability due to defect. Damage not caused by normal wear and tear or failure to follow the safety and maintenance instructions provided in the user manual. What is not covered by the warranty?

The warranty does not cover damage caused by:

Normal wear and tear of the product, including fragile parts (such as switches, glass, etc.);

Improper use or transport;

Disregarding safety and maintenance instructions;

Accidents or acts of nature (e.g. lightning, re, water, etc.);

Tampering with the product (such as removing cover, un-

screwing screws etc.). Consequential and incidental damages are also not covered under this warranty. However, some states do not allow the US-EN 47 6870_silv_Blutdruckmessgeraet_Content_US.indd 47 04.07.19 09:1 exclusion or limitation of incidental or consequential dam-

ages, so this limitation or exclusion may not apply to you. What is the period of coverage and warranty resolution?

The warranty is for 3 years from the date of purchase. At our discretion, product will either be refunded or replaced. What will we not do?

We will not:

Start a new warranty period upon product exchange;

Repair product. How to process the warranty?

To initiate, please:

Call customer service at 1 (844) 543-5872 Visit the Website Customer Service Platform at www.lidl.com/contact-us or Visit a LIDL store for further assistance To ensure the quickest warranty return process, please have the following available:

The original sales receipt that includes the date purchased;

The product and manual in the original package;

A statement of the problem. 48 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 48 04.07.19 09:1 What must you do to keep the warranty in effect?

Retain the original receipt;

Follow all product instructions;

Do not repair or modify the product. How does state law relate to this warranty?

This warranty gives you specic legal rights, and you may also have other rights which vary from state to state. All im-

plied warranties are limited by the duration and terms of this warranty. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. US-EN 49 6870_silv_Blutdruckmessgeraet_Content_US.indd 49 04.07.19 09:1 The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Hans Dinslage GmbH is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Google Play and the Google Play logo are trademarks of Google LLC. Android is a trademark of Google LLC. 50 US-EN 6870_silv_Blutdruckmessgeraet_Content_US.indd 50 04.07.19 09:1 US-ES 51 6870_silv_Blutdruckmessgeraet_Content_US.indd 51 04.07.19 09:1 52 US-ES 6870_silv_Blutdruckmessgeraet_Content_US.indd 52 04.07.19 09:1 US-ES 53 6870_silv_Blutdruckmessgeraet_Content_US.indd 53 04.07.19 09:1 Service Band

(MHz) Test Fre-

quency Table 3:

Guidance and manufacturers declaration -

electromagnetic immunity:

Radiated RF IEC61000-

4-3 (Test specifica-

tions for ENCLOSURE PORT IMMU-

NITY to RF wireless communica-

tions equip-

ment) 385 450 710 745 780 810 870 930 380390 430470 704787 800960 TETRA 400 GMRS 460:

FRS 460 LTE Band 13, 17 GSM 800 / 900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 58 6870_silv_Blutdruckmessgeraet_Content_US.indd 58 04.07.19 09:1 Test Fre-

quency Band

(MHz) Service Radiated RF IEC61000-

4-3 (Test specifica-

tions for ENCLOSURE PORT IMMU-

NITY to RF wireless communica-

tions equip-

ment) 17001990 GSM 1800;

1720 1845 1970 2450 24002570 CDMA 1900; GSM 1900; DECT;

LTE Band 1, 3, 4, 25;

UMTS Bluetooth, WLAN, 802.11 b / g / n, RFID 2450, LTE Band 7 51005800 WLAN 802.11 a / n 5240 5500 5785 59 6870_silv_Blutdruckmessgeraet_Content_US.indd 59 04.07.19 09:1 Modu-

lation Modu-

lation

(W) Table 3:

Guidance and manufacturers declaration -

electromagnetic immunity:

Radiated RF IEC61000-

4-3 (Test specifica-

tions for ENCLOSURE PORT IMMU-

NITY to RF wireless communica-

tions equip-

ment) Dis-

tance

(m) IMMU-

NITY TEST LEVEL

(V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 Pulse modula-

tion b) 18 Hz FM c) 5kHz de-

viation 1 kHz sine Pulse modula-

tion b) 217 Hz Pulse modula-

tion b) 18 Hz 60 6870_silv_Blutdruckmessgeraet_Content_US.indd 60 04.07.19 09:1 Modu-

lation Modu-

lation

(W) Dis-

tance

(m) IMMU-

NITY TEST LEVEL

(V/m) Radiated RF IEC61000-

4-3 (Test specifica-

tions for ENCLOSURE PORT IMMU-

NITY to RF wireless communica-

tions equip-

ment) 2 2 0.3 28 0.3 28 0.2 0.3 9 Pulse modula-

tion b) 217 Hz Pulse modula-

tion b) 217 Hz Pulse modula-

tion b) 217 Hz 61 6870_silv_Blutdruckmessgeraet_Content_US.indd 61 04.07.19 09:1 62 6870_silv_Blutdruckmessgeraet_Content_US.indd 62 04.07.19 09:1

Internal Photos P1 of P4 P2 of P4 P3 of P4 P4 of P4

External photos General view Front view P1 of P4 Back view Side view P2 of P4 Side view P3 of P4 Side view Side view P4 of P4

location 1 2 3 4 5 6 194/62/ECTPCH 2 3 2019-04-15 TMB-1891-008

-

50#

27*14mm 1:1

-

PO#2F4128-TMB-1891-008-GB-01-FCC-A0 2019-04-15 2019-04-15 2019-04-15 TMB-1891-008-GB-01 1 1 A/0

Date (2019-7-17) TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: OU9SBM69-B01 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, (Guangdong Transtek Medical Electronics Co., Ltd, Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan , 528437, Guangdong, China) hereby requests permanent confidential treatment of information accompanying this application as outlined below:

Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation 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:Kevin Tan Telephone Number: +86-760-85166220 Email: wan.hu@lifesense.com

Guangdong Transtek Medical Electronics Co., Ltd. Registration Address: Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong, China Tel.: 86-760-8828 2982 Party A authorizes Party B and its subsidiaries to manufacture [ Blood Pressure Monitors ] . Party A and Party B reach the below agreements so as to legitimate the use of Trademark from Party A by Party B during production. 1. Trademark Authorization

(1). The Party A has the legally proprietary or the legal right of use Beurer, Sanitas, Vitalcontral or Silvercrest trademark(Licensed Trademark). Party B complies with product specifications, logo printing, product patterns and the same as trademark-related information provided by Party A in production through, but not limit to, all agreements by Sales Contract, Purchasing Order, or emails.

(2). Party A authorized Party B and its subsidiaries to free use the authorized trademark in the production of [Blood Pressure Monitors] and according to the specfication. 2. The rights and obligations of Party A.

(1). Party A has the right to authorize the trademark to any other third parties.

(2). Party A should ensure that a continuing legal proprietary or right to use licensed trademark.

(3) If the Party B is accused of infringement because of the defects of the trademark legal right cause by Party A, Party A should be responsible for negotiation with the third party and compensate for all verifiable loss of Party B caused by case. CMM meee item click) slay mee Trademark Authorization Agreement Beurer GmbH, S6flinger StraRe 218, 89077 Ulm, Germany

(1) Party B and its subsidiaries has the right to manufacture the products with authorized trademark in China.

(2) Party B can authorize the third party to use and do production with the authorized trademark with the prior written approval from Party A. EIN ANA CMO NAS BM ere em ORD ar ce trademark to Party A or the appointed third party by Party A.

(4) Party B cannot authorize the trademark to the third party without the prior written approval from Party A. 4. Violation Responsibility PNA TaN RUA ALAA <eoM aeRO oD -xe1UCO AM Lal (a aCe Le oa loss to the other party, should compensate the other party for the verifiable losses. 7. The effective of this Agreement and Miscellaneous ORME teeter eRe ceR ict ReMi Re CIRO Tee SU Leek

(2). This agreement shall be long-term effective unless both parties to Clan arecomunl es

=A cotta OL

(3). Any amendment, modification, plus or minus clause to this agreement should be signed relevant written documents by both parties as the integral parts of this agreement and should have the equal effect as this agreement.

(4). This agreement is in duplicate, both party hold one original documents. 6. Dispute Settlement

(1). Both parties shall settle through friendly negotiation if any disputes arising from or in connection with this agreement.

(2). In the process of the handling the disputes, except the arbitrated parts, other parts of this agreement will be continued to perform. 5. Application of Law The effective, executing and termination of this agreement apply to German law Party B: Guan ! Electronics Co. Ltd Sign&Chop:

er iT CL ean |

Date: 20190808 Party A: Beurer GmbH Sign&Chop: