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1 | User Manual | Users Manual | 780.88 KiB | July 07 2021 |
Signs and symbols ................................................ Page 7 Description of signal words ......................... Page 7 Customer service .................................................... Page 8 List of pictograms used .................................... Page 8 Upper Arm Blood Pressure Monitor ..... Page 10 Introduction ................................................................ Page 10 Intended purpose ............................................................Page 10 Target group ....................................................................Page 11 Clinical use .......................................................................Page 11 Indication .........................................................................Page 12 Contraindication ..............................................................Page 12 Parts description...............................................................Page 13 Scope of delivery .............................................................Page 16 Technical data .................................................................Page 16 Warning and safety instructions ............Page 19 General warning instructions ..........................................Page 19 General precautions ........................................................Page 21 Safety warnings for batteries ..........................................Page 22 Information on electromagnetic compatibility................Page 25 FCC compliance information ..........................................Page 26 Initial use ......................................................................Page 27 Inserting / Replacing batteries .........................................Page 27 App / web version of HealthForYou ...........................Page 28 Changing the date / time / time format /
Bluetooth settings ...........................................................Page 29 Activating and deactivating Bluetooth .........................Page 30 V3.0 US-EN 5 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 5 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 5 17.05.21 16:40 17.05.21 16:40 Measuring blood pressure...........................Page 31 Attaching the cuff .............................................................Page 32 Adopting the correct posture ..........................................Page 34 Selecting a memory .........................................................Page 35 Carrying out the blood pressure measurement .............Page 35 Transferring measurements via Bluetooth ..........................................................Page 37 Evaluating Measurements............................Page 38 General information about blood pressure ...................Page 38 Cardiac arrhythmia .........................................................Page 39 Risk indicator ....................................................................Page 40 Saving, requesting and deleting measurements ..................................Page 42 Restoring the device to its factory settings .......................................................Page 44 Cleaning and care ................................................Page 44 Storage ..........................................................................Page 45 Troubleshooting.....................................................Page 46 Disposal .........................................................................Page 47 Notes on electromagnetic compatibility .............................................................Page 47 Three year limited warranty .....................Page 48 6 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 6 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 6 17.05.21 16:40 17.05.21 16:40 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 property 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. ATTENTION 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 7 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 7 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 7 17.05.21 16:40 17.05.21 16:40 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 366723_2101 Please have your IAN number ready. List of pictograms used WARNING Warning of risks of injury or health ha-
zards ATTENTION This symbol shows that caution should be exercised if devices or controllers are being operated near this symbol or that the current situation requires attentiveness or intervention from the operator to avoid unintended consequences. Note on important information Instructions 8 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 8 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 8 17.05.21 16:40 17.05.21 16:40 List of pictograms used Observe instructions for use Direct current Storage /
Transport Operating Permissable storage and transport temperature and humidity Permissible operating temperature and humidity Permissible storage, transport and operating air pressure Manufacturer Applied part, type BF Serial number IP21 Device protected against foreign matter 0.49 in (12.5 mm) and against water falling vertically Data transfer via Bluetooth low energy technology US-EN 9 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 9 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 9 17.05.21 16:40 17.05.21 16:40 List of pictograms used b a Dispose of the packaging and device in an environmentally-friendly manner!
Upper Arm Blood Pressure Monitor Introduction Familiarize yourself with the upper arm blood pressure monitor before using it for the first time. Please carefully read the following instructions for use and the important safety notes. Failure to observe the no-
tes may result in personal injury or property damage. Only use the upper arm blood pressure monitor as described and for the indicated purposes. Keep these instructions for use in a safe place. Include all documentation when passing the up-
per arm blood pressure monitor on to third parties. Intended use Intended purpose 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 to 16.5 in
(22 cm to 42 cm), in a non-invasive way. 10 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 10 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 10 17.05.21 16:40 17.05.21 16:40 Using this device, you can quickly and easily measure your blood pressure, save the measurements and display the progression and average of these measurements. The re-
corded measurements are classified and evaluated graphi-
cally. A symbol in the display also warns of possible cardiac arrhythmia. If this symbol lights up in the display after the measurement, please consult your doctor for diagnosis. Any use other than previously mentioned or any product modifi-
cation 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). Target group Blood pressure measurement is suitable for adult users whose upper arm circumference is within the area printed on the cuff. Clinical use The user can quickly and easily record their blood pressure and pulse values using the device. The blood pressure mea-
surement values recorded are classified in accordance with internationally applicable guidelines and evaluated graphi-
cally. Furthermore, the device can identify irregular heartbeats occurring during the measurement and inform the user via a symbol on the display. The device saves the displayed US-EN 11 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 11 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 11 17.05.21 16:40 17.05.21 16:40 measurement values and can also provide average values of previous measurements. The data recorded can support health service providers when diagnosing and treating blood pressure problems and thus contribute to the long-
term monitoring of the users health. Indication If the user has hypertension or hypotension, they can moni-
tor their blood pressure, pulse values and possible existing cardiac arrhythmia, in a home environment. However, the user does not have to suffer from hypertension or arrhyth-
mias to use the device. Contraindication Failure to observe the following warnings can result in death or serious injuries. Do not use this product on newborns and pre-eclampsia patients. We recommend con-
sulting 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 defibrillators. Do not use the device if you have metal implants. Before using the device under any of the following cir-
cumstances, it is absolutely necessary that you consult 12 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 12 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 12 17.05.21 16:40 17.05.21 16:40 a doctor: cardiac arrhythmias, circulation problems, diabetes, hypotension, chills, tremors. Do not use the product in conjunction with a high-fre-
quency surgical unit. Ensure that the cuff is not placed on an arm of a person whose arteries or veins are undergoing medical treat-
ment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt. Failure to observe the following warnings can result in injuries or property damage. People with limited physical, sensory or mental abilities should be supervised by a person responsible for their safety and adhere to this persons instructions for using the device. Do not place the cuff on individuals who have had a mastectomy. Do not place the cuff over wounds as this could lead to further injuries. Do not use the device on people with allergies or sensitive skin. Parts description 1 Cuff 2 Cuff tubing 3 Cuff plug 4 Display US-EN 13 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 13 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 13 17.05.21 16:40 17.05.21 16:40 5 Memory button M 6 Settings button SET 7 Function button -/+
8 START/STOP button 9 Risk indicator 10 Connection for cuff plug 11 Battery compartment 1 2 4 3 9 10 8 5 6 7 10 11 14 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 14 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 14 17.05.21 16:40 17.05.21 16:40 Display indicators 12 Time and date 13 Systolic pressure 14 Diastolic pressure 15 Pulse value determined 16 Symbol for cardiac arrhythmia Symbol for pulse 17 Memory display: Average value (A), morning (AM), evening (PM), number of the memory space 18 Symbol for replace battery 19 Risk indicator 20 Release air 21 User memory 22 Symbol for Bluetooth transfer 23 Cuff position control 23 12 22 21 20 19 18 17 16 15 13 14 US-EN 15 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 15 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 15 17.05.21 16:40 17.05.21 16:40 Scope of delivery 1 Upper arm blood pressure monitor 1 Upper arm cuff (material no. 164.386 cuff SBM 69) with cuff tubing 4 Batteries 1.5 V type AAA LR03 1 Instructions for use 1 Quick start guide 1 Blood pressure record card 1 Storage pouch Technical data Type:
Measuring method:
Measurement range:
Pulse value:
Display accuracy:
Measurement uncertainty:
16 US-EN SBM 69 Oscillometric, non-invasive blood pressure measurement on the upper arm Rated cuff pressure: 0-299 mmHg, Measurement pressure:
Systolic: 60230 mmHg Diastolic: 40130 mmHg 40-199 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 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 16 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 16 17.05.21 16:40 17.05.21 16:40 Memory:
Dimensions:
Cuff:
Weight:
Permissible operating conditions:
Permissible storage conditions:
Power supply:
Product expected lifespan:
Battery life:
Classification:
2 x 100 memory spaces L 5.3 in (134.5 mm) x W 3.9 in
(100 mm) x H 2 in (51,0 mm) suitable for an arm circumference between 8.7 in and 16.5 in (22 cm and 42 cm) 0.87 lb (395 g) (with cuff, without batteries) 41 F to 104 F (+5 C to +40 C), 15 % to 90 % relative humidity
(non-condensing), 700-1060 hPa ambient pressure
-4 F to 140 F (-20 C to +60 C), 93 % relative humidity (not con-
densing), 7001060 hPa ambient pressure 4 x 1.5 V AAA batteries 5 years 225 measurements, depending on blood pressure level and inflation pressure / Bluetooth transfer Internal supply, IP21, no AP or APG, continuous operation, applied part Type BF US-EN 17 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 17 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 17 17.05.21 16:40 17.05.21 16:40 Data transfer via Bluetooth low energy technology:
System requirements of the HealthForYou web version:
The product uses Bluetooth low energy technology, frequency band 2.4022.480 GHz, maximum transmission power radiated in the frequency band < -1.5 dBm For a list of compatible smart phones, information about the HealthForYou app and software, as well as further details about the devices, please visit: www.healthforyou.lidl
- MS Internet Explorer
- MS Edge
- Mozilla Firefox
- Google Chrome
- Apple Safari
(in the respective updated version) System requirements of the HealthForYou app:
iOS from Version 12.0; AndroidTM from 8.0; Bluetooth from 4.0 Technical specifications subject to change without notice due to updates. 18 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 18 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 18 17.05.21 16:40 17.05.21 16:40 Warning and safety instructions READ ALL INSTRUCTIONS. KEEP FOR FUTURE REFERENCE. INCLUDE ALL DOCUMENTATION WHEN PASSING THIS PRODUCT ON TO OTHERS. General warning instructions Failure to observe the following warnings can result in death or serious injuries. The measurements you take are only intended for your information - they do not replace a medical examination!
Discuss your measured values with a doctor. Under no circumstances should you make medical decisions by yourself on the basis of these values (e.g. with regard to medication dosages)!
Cardiovascular system diseases may result in incorrect measurements and/or impairments to the devices mea-
surement accuracy. Do not use the device at the same time as other medical electrical devices (ME devices). This could lead to the measurement device malfunctioning and/or an inaccu-
rate measurement. Blood circulation should not be restricted by the blood pressure measurement for an unnecessary amount of time. Remove the cuff from the arm if the device mal-
functions. The air tube poses a risk of strangulation for infants. Furthermore, the small parts the product contains US-EN 19 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 19 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 19 17.05.21 16:40 17.05.21 16:40 present a choking hazard for infants if swallowed. They should therefore always be supervised. Do not use the sphygmomanometer in conjunction with a high-frequency surgical unit. Do not use the device with a defibrillator. Do not use the device during an MRI scan. Failure to observe the following warnings can result in injuries or property damage. Ensure that the limb is not functionally impaired when inflating the cuff. Do not take measurements more often than necessary. Due to the limitation to blood flow, it can lead to the development of bruising. Only place the cuff on the upper arm. Do not place the cuff on other body parts. Do not expose the device to static electricity. Always ensure that no static electricity is coming off of you before you operate the device. The device is only intended for the purpose described in these instructions for use. The manufacturer is not lia-
ble for damage caused by improper or incorrect use. Using the blood pressure monitor outside the domestic environment or under the influence of movement (e.g. whilst riding in cars, ambulances or helicopters as well as whilst practising physical activities such as sport) can 20 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 20 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 20 17.05.21 16:40 17.05.21 16:40 impact the accuracy of the measurement and lead to measurement errors. Do not use the device outside of the stated storage and operating conditions. This could lead to incorrect mea-
surement results. Do not place the device in pressure receptacles or gas sterilisation devices. Do not allow the device to fall and also avoid stepping on or shaking the device. Do not disassemble the device, as this can lead to dam-
age, malfunctions and faults. Do not use rechargeable batteries. If no button is pressed, the automatic shutoff will switch off the sphygmomanometer within 1 minute to save the batteries. Only use the cuffs supplied with this device or described in these instructions for use. Using another cuff can lead to inaccurate measurements. General precautions Attention! Potential damage to the device. The sphyg-
momanometer 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. US-EN 21 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 21 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 21 17.05.21 16:40 17.05.21 16:40 Protect the device from impacts, moisture, dirt, severe temperature fluctuations and direct sunlight. Do not drop the device. Bring the device to room temperature before taking measurements. If the measuring device has been stored near to the maximum or minimum storage and transport temperature and is brought into an environment with a temperature of 68 F ( 20 C), it is recommended that you wait 2 hours before using the measuring device. Avoid mechanically restricting, compressing or kinking the cuff tubing. Routinely inspect the device to ensure the device is not visibly damaged before use and the battery level is sufficient. When in doubt, do not use and contact the service department or an authorised retailer. Do not use additional parts not recommended or sold as com-
ponents by the manufacturer. Never open or repair the device or proper function cannot be guaranteed. Non-compliance will void the warranty. Please contact the service department or an authorised retailer for repairs. However, before making a complaint, firstly check the batteries and replace them if necessary. Safety warnings for batteries When used correctly, cells and batteries provide a safe and dependable source of portable power. However, if 22 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 22 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 22 17.05.21 16:40 17.05.21 16:40 they are misused or abused, this may result in leakage, burns, fire, or explosion. Store batteries in a dry place at room temperature. Bat-
teries are sensitive to high and low temperatures. Such thermal exposure may lead to leakage, fire, or explosion. Keep cells and batteries out of reach of children and pets, especially 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. 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 flush 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, fire, 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). US-EN 23 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 23 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 23 17.05.21 16:40 17.05.21 16:40 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 obser-
ved to avoid damage to either product or batteries. Always replace the whole set of batteries at one time, taking care not to mix old and new ones, or batteries of different types, capacities, or manufacturers. Never heat batteries in order to revive them. Never charge a battery unless the battery label specifi-
cally states the battery is rechargeable. Charging a non-rechargeable battery, may result in leakage, fire, or explosion. Use only the power cord supplied with the product. The use of other cords may result in the batteries inside the product being charged. 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 ingested. Do not drop or subject the cell or battery to strong mechanical shock. Batteries should not be disassembled, crushed, punc-
tured, or otherwise mutilated. Such abuses may result in leakage, fire, or explosion. 24 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 24 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 24 17.05.21 16:40 17.05.21 16:40 Do not dispose of the battery in a fire. Failure to observe this precaution may result in an explosion. Dispose of batteries properly and in accordance with government regulations. Information on electromagnetic compatibility The device is suitable for use in all environments that are listed in these instructions for use, including in the home. In the presence of electromagnetic disturbances, the device may under some circumstances only be useable to a limited extent. This can result in error messages or the breakdown of the display / device, for example. The use of the device immediately next to other devices or stacked with other devices is to be avoided, as this can result in faulty operation. If it is necessary to use the device in such a way in spite of this, this device and the other device should be monitored to make sure that they are working correctly. The use of equipment other than that which has been specified or made available by the manufacturer of this device can lead to increased electromagnetic interfer-
ence or the reduced electromagnetic stability of the device and can lead to faulty functioning. Failure to observe these instructions may lead to a re-
duction in the performance features of the device. US-EN 25 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 25 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 25 17.05.21 16:40 17.05.21 16:40 FCC compliance information FCC ID: OU9TMB1891HJ This product complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) This product may not cause harmful interference, and 2) this product must accept any interference received, including interference that may cause undesired operation. Changes or modifications to this product not expressly approved by the party responsible for compliance could void the users authority to oper-
ate the product. Note: This product has been tested and complies with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.These limits are designed to pro-
vide reasonable protection against harmful interference in a residential installation. This product generates, uses and can radiate radio frequency energy and, if not in-
stalled and used in accordance with the instructions, may cause harmful interference in radio communica-
tions. However, there is no guarantee that interference will not occur in a particular installation. If this product causes harmful interference to radio or television reception, which can be determined by turning the product off and on, the user is encouraged to try and correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the distance between the equipment and receiver. 26 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 26 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 26 17.05.21 16:40 17.05.21 16:40 Connect the product into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio / TV tech-
nician for help. SAVE THESE INSTRUCTIONS Initial use Verify the parts listed in the scope of delivery are complete. Remove all packaging material. Inserting / Replacing batteries Slide the battery cover off the battery compartment 11 . 10 11 US-EN 27 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 27 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 27 17.05.21 16:40 17.05.21 16:40 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. Carefully close the battery cover on the battery com-
partment 11 . Do not use rechargeable batteries. Note: if the change battery indicator 18 is displayed continuously, measurement will not be possible until all batteries have been replaced. As soon as the batteries have been removed from the device, the date and time will be reset. Saved measurements will still be stored. All display elements will be shown briefly and 24h will flash on the display. Now set the date, time, time format and Bluetooth (see the chapter Changing the date / time / time format / Bluetooth settings). 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 find guidance for assessment. The HealthForYou privacy policy can be viewed via the following link: www.healthforyou.lidl/privacy.html 28 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 28 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 28 17.05.21 16:40 17.05.21 16:40 Changing the date / time /
time format / Bluetooth settings Configure 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 different ways:
Before first 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-off device, hold the settings button SET 6 pressed for 5 seconds. Now proceed as follows:
The time format will flash. Use the function buttons -/+ 7 to set the format to 12-hour or 24-hour. Press the SET button 6 to confirm. The year will flash. Use the function buttons - / + 7 to set the year. Press the SET button 6 to confirm. The month will flash. Use the function buttons - / + 7 to set the month. Press the SET button 6 to confirm. Configure the day, hour and minute consecutively as described above. Press the SET 6 button to confirm each entry. US-EN 29 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 29 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 29 17.05.21 16:40 17.05.21 16:40 The Bluetooth symbol will be shown on the display. On and OFF will flash at the same time. Using the function buttons - / +, choose whether you want to activate (On flashes) or deactivate (OFF flashes) Bluetooth data transfer. Press the SET button 6 to confirm. 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. Activating and deactivating Bluetooth You can activate or deactivate the devices Bluetooth function at any time, independently of the other settings. Proceed as follows:
With the device switched off, briefly press the settings button SET 6 . You will now see the Bluetooth symbol 22 in the display 4 , On or OFF will flash simulta-
neously. Now activate or deactivate data transfer using the func-
tion buttons -/+ 7 (Activated: On flashes in the the display 4 . Deactivated: OFF flashes in the display 4 .). Confirm your selection using the settings button SET 6 . The device will then automatically switch off. 30 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 30 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 30 17.05.21 16:40 17.05.21 16:40 Measuring blood pressure Note: To generate an informative profile of the devel-
opment of your blood pressure and thus guarantee that you will be able to compare the measured values ade-
quately, measure your blood pressure regularly and al-
ways at the same time of day. It is recommended that you measure blood pressure twice a day: once in the morning after getting up and once in the evening. You should not eat, drink, smoke or be physically active in the 30 minutes before each measurement. Before taking the first blood pressure measurement, always rest for 5 minutes!
The measurement should always be taken in an ade-
quate state of physical rest. You should therefore avoid taking measurements at stressful times. Furthermore, if you wish to take multiple measurements one after the other, always wait at least 1 minute be-
tween each measurement. Repeat the measurement process if the measured values seem incorrect. Bring the device to room temperature before taking measurements. Only place the cuff on the upper arm. Do not place the cuff on other body parts The sphygmomanometer can only be operated with batteries. Please be aware that data transfer and data storage are only possible if your sphygmomanometer is powered on. If the batteries are drained, the date and time will be deleted from the sphygmomanometer. US-EN 31 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 31 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 31 17.05.21 16:40 17.05.21 16:40 Attaching the cuff Failure to observe the follow-
ing warnings can result in injuries or property damage. Only use the device with the original cuff. The cuff is suitable for an upper arm circumference of between 8.7 in16.5 in (22 cm and 42 cm). The correct fit should be checked before the measurement is taken us-
ing the index markings described below. Place the cuff 1 on a bare upper arm. The blood flow of the arm should not be constricted by clothing etc. which is too tight. 1 Position the cuff 1 on the upper arm so the lower edge is 0.79 in1.18 in (2 cm3 cm) up from the elbow and over the artery. The cuff tubing 2 points towards the middle of the palm. 32 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 32 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 32 17.05.21 16:40 17.05.21 16:40 Place the free end of the cuff 1 closely, but not too tightly, around the arm and close the Velcro strip. The cuff 1 should not be too tight. 1 2 Check that two fingers can still fit beneath the cuff 1 . 1 2 This cuff is suitable for you if, after putting it on, the index mark on the outside of the cuff () is within the OK range on the cuff. 1 US-EN 33 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 33 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 33 17.05.21 16:40 17.05.21 16:40 Now insert the cuff tubing 2 with the cuff plug 3 into the connector 10 . 3 10 2 If the measurement is being taken using the right upper arm, the air tube should be over the inner side of your elbow. Ensure that you do not press on the air tube with your arm. Adopting the correct posture Note: Stay still during the measurement process and do not talk to prevent the measurement result from being falsified. You can carry out the measurement while sitting or lying down. Always ensure that the cuff 1 is at the same level as the heart Sit comfortably for the blood pressure measurement. Recline your back and arms. Do not cross your legs. Put your feet flat on the ground. 34 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 34 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 34 17.05.21 16:40 17.05.21 16:40 In order not to falsify the measurement result, it is im-
portant that you stay still and do not talk. Selecting a memory There are 2 memories available, each with 100 memory spaces, so that you can save the measured values of 2 dif-
ferent people separately. With the device switched off, press the START / STOP 8 . The most recently selected user button memory will flash in the display 4 this is User 1 in the default settings. You can now use the function buttons -/+ 7 to select the desired user memory. Confirm your selection by pressing the START / STOP button 8 again. The device will then auto-
matically begin measuring values. Carrying out the blood pressure measurement Place the cuff on your arm as previously described and assume the position in which you wish to carry out the measurement. Start the blood pressure monitor using the START / STOP button 8 and select the desired user memory as described in the Chapter Selecting a memory. US-EN 35 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 35 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 35 17.05.21 16:40 17.05.21 16:40 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 you have confirmed the user selection using the START /
STOP button 8 , the blood pressure monitor auto-
matically begins measuring by inflating the cuff. The mea-
surement is taken while the cuff is being pumped up. As soon as a pulse has been detected, the pulse symbol will be dis-
played. After this, the cuff air pressure will be released again. The measurement results for systolic pressure, diastolic pres-
sure and pulse will be displayed. 8 . 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. To power down press the START / STOP button 8 . Note: The device switches off automatically after one minute if no button has been pressed. Wait for at least one minute before taking another measurement!
36 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 36 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 36 17.05.21 16:40 17.05.21 16:40 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 transfer to occur. Add SBM69 in the app. When connecting for the first time, a randomly generated six-digit PIN code will be displayed on the device over two lines. At the same time, an entry field 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. Warning! The displayed values are intended merely as a visualisation and may not be used as the basis for therapeu-
tic measures. The software is not part of a diagnostic medi-
cal system. We wish to expressly indicate that the software at hand is not a medical product in accordance with the EU directive 93/42/EEC. Note: During data transfer, button functions cannot be executed. To transfer measurements to your smartphone via Bluetooth proceed as follows:
US-EN 37 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 37 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 37 17.05.21 16:40 17.05.21 16:40 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 off by pressing the START / STOP button 8 . Automatic transfer If you forget to switch off the blood pressure monitor, it will automatically switch off 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 dis-
play during transfer. Evaluating Measurements General information about blood pressure Blood pressure is the force with which the bloodstream presses against the arterial walls. Arterial blood pressure changes continuously over the course of a cardiac cycle. The blood pressure figure is always given in the form of two values.
- The highest pressure in the cycle is called the systolic 38 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 38 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 38 17.05.21 16:40 17.05.21 16:40 blood pressure. It occurs when the heart muscle draws together and presses the blood into the vessels.
- The lowest number is the diastolic blood pressure, which then occurs when the heart muscle has fully stretched out again and the heart fills with blood. Blood pressure fluctuations are normal. Even on a re-
peat measurement, observable differences between the measured values can arise. One-time or irregular mea-
surements therefore do not provide a reliable indication of the actual blood pressure. A reliable assessment is only possible if you regularly measure your blood pres-
sure under comparable conditions. Cuff position control The device has a cuff position control. Using this function, the device automatically checks the correct position of the cuff on your upper arm whilst it is taking a measurement. If the cuff 1 has been correctly positioned, the symbol 23 will appear in the display 4 during inflation. It will stay there until the measurement has successfully been taken and will then be shown together with the recorded values. Cardiac arrhythmia This device can identify any potential cardiac arrhythmia disorders and, if necessary, indicates this after the measurement US-EN 39 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 39 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 39 17.05.21 16:40 17.05.21 16:40
. This can be an indicator for process with the symbol arrhythmia. 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 Failure to observe the following warnings can result in death or serious injuries. is displayed repeatedly, contact your If the symbol doctor. Self-diagnosis and self-treatment on the basis of measurement results can be dangerous. Follow your doctors instructions. Risk indicator In accordance with the guidelines / definitions provided by the Joint National Committee (JNC) and the latest findings, the measurement results can be classified and evaluated ac-
cording to the following table:
40 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 40 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 40 17.05.21 16:40 17.05.21 16:40 Stages of blood pressure levels Stage 2:
Hypertension Systolic
(mmHg) Diastole
(mmHg) Color Measure 180 110 160179 100109 Red Stage 1:
Hypertension 140159 9099 Pre-hyperten-
sion 130139 8589 120129 8084 Normal
< 120
< 80 Source: U.S. Department of Health and Human Service, JNC 8(2014), adapted The JNC chart is not intended to replace a medical diagnosis. This chart is only a reference for different classifications of blood pressure. Red Red Seek medical advice Seek medical advice Have it checked regularly by a doctor Yellow Have it checked regularly by a doctor Yellow Check it yourself Green Check it yourself US-EN 41 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 41 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 41 17.05.21 16:40 17.05.21 16:40 Note: These standard values merely serve as a general guideline as blood pressure deviates depending on the individual, different age groups, etc. It is important that you consult your doctor at regularly. Your doctor will provide you with your particular values for nor-
mal blood pressure as well as the value for when your blood pressure is classified 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 dif-
ferent JNC ranges (e.g. systolic in the Stage 1 Hypertension range and diastolic pressure in the normal rage) the graphic JNC classification 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 100 mea-
surement values, the oldest measurement value will be over-
written. With the device switched off, press the START / STOP button
. 8 to select the desired user memory Confirm your selection by pressing the memory button M 5 . 42 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 42 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 42 17.05.21 16:40 17.05.21 16:40 A will flash in the display 4 and an average of all the saved measurements in the selected user memory will be shown. Press the memory button M 5 again to display the av-
erage value of the last 7 days for the morning measure-
ment. (Morning: 5.00 am 9.00 am, display AM). Press the memory button M 5 again to display the av-
erage value of the last 7 days for the evening measure-
ment. (Evening: 6 pm 8 pm, display 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 8 to switch off the device. Note: The device switches off automatically after one minute when no button has been pressed. Deleting a selected user memory To delete the memory of the selected user, press the memory button M 5 when the device is switched off. The average value of all measurements will appear on the display. Next to this, A and the Bluetooth trans-
fer symbol 22 will flash. 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. US-EN 43 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 43 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 43 17.05.21 16:40 17.05.21 16:40 Restoring the device to its factory settings You can delete all of the data saved on the device, e.g. settings or saved measured values, by restoring the device to its factory settings. Proceed as follows:
With the device switched off, press the memory button M 5 . You will then be in the most recently selected user memory. A will flash in the display 4 . Now press the memory button M 5 again to switch to the display mode for the average morning value. AM will flash in the display 4 . Hold down both function buttons -/+ 7 at the same time for 15 seconds, until CL ALL appears in the dis-
play 4 . Now all of the data saved on the device will be deleted and the device will be restored to its factory settings. 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 cuff 1 carefully using a slightly damp cloth. Do not use cleaners or solvents. 44 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 44 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 44 17.05.21 16:40 17.05.21 16:40 Storage Possible property damage! Do not place any heavy objects on the device and cuff 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 cuff 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 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 45 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 45 17.05.21 16:40 17.05.21 16:40 Troubleshooting Trouble-
shooting Problem Solution Repeat the measure-
ment process. Be sure not to move or talk. The pulse cannot be measured correctly. You have been talking or moving during the measurement process. The cuff was attached too tightly or too loosely. An error occurred during the measure-
ment process. The pump-up pressure is higher than 300 mmHg or the blood pressure measurement falls out-
side of the measuring range. The batteries are almost dead. Data cannot be sent via Bluetooth. A device error has occurred. Er1 Er2 Er3 Er4 Er5 Er6 Er7 Er8 46 US-EN Reinsert the batteries or replace them with new batteries. Activate Bluetooth on your smartphone and start the HealthForYou app. Repeat the measure-
ment process. Be sure not to move or talk. 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 46 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 46 17.05.21 16:40 17.05.21 16:40 Problem Solution Trouble-
shooting OUT Out of maswuremet range
- Relax for a moment.
- Refasten the cuff and then measure again.
- If the problem per-
sists, contact your physician. Disposal Observe the local regulations for material disposal. Dispose of the device and batteries in accordance with local regula-
tions. If you have any questions, please contact the local waste management authorities. Notes on electromagnetic compatibility The device is suitable for use in all environments listed in these instructions for use, including domestic environ-
ments. The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display /
device. US-EN 47 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 47 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 47 17.05.21 16:40 17.05.21 16:40 Avoid using this device directly next to other devices or on top of other devices, as this could cause malfunctions. However, if the device must be used in this manner, this device and the other devices must be monitored to en-
sure they are working properly. Using accessories other than those specified or provided by the manufacturer of this device can increase electro-
magnetic emissions or decrease the devices electro-
magnetic immunity, which can cause malfunctions. Failure to comply with the above can impair device performance. 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, fire, water, etc.);
48 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 48 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 48 17.05.21 16:40 17.05.21 16:40 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 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;
US-EN 49 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 49 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 49 17.05.21 16:40 17.05.21 16:40 The product and manual in the original package;
A statement of the problem. 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 specific 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. This device complies with European Standard EN 60601-1-2
(in accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special precautions with respect to electromagnetic compatibility. The device is suitable for use in all environments listed in these instructions for use, including domestic environments. Please note, portable and mobile HF communication devices may interfere with this device. Das Gert entspricht der EU-Richtlinie fr Medizinpro-
dukte 93/42/EEC,dem Medizinproduktegesetz und der Norm IEC 80601-2-30 (Medical electrical equipment Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive blood pressure monitors). 50 US-EN 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 50 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 50 17.05.21 16:40 17.05.21 16:40 The accuracy of this blood pressure monitor has been thoroughly tested and was developed with regard to a long utilizable service life. If the device is used in medicine, tech-
nical inspections using the suitable equipment are to be car-
ried out. Precise information on how to test the accuracy of the device can be requested from our service address. We hereby affirm that this product complies with the European RED Directive 2014/53/EU. www.sanitas-online.de/web/de/landingpages/
cedeclarationofconformity.php US-EN 51 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 51 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 51 17.05.21 16:40 17.05.21 16:40 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. Guangdong Transtek Medical Elctronics Co., Ltd. Zone A, No. 105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China 52 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 52 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 52 17.05.21 16:40 17.05.21 16:40 Notes on electromagnetic compatibility The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on. Warning: Dont 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 equip-
ment 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. Warning: Portable 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 equipment (SBM69), including cables specified by the manufacturer. Otherwise, degradation of the perfor-
mance of this equipment could result. If any: a 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 53 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 53 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 53 17.05.21 16:40 17.05.21 16:40 or ME SYSTEM with the requirements of Clause 7 (EMIS-
SIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load im-
pedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE). If any: the 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 PERFOR-
MANCE is lost or degraded due to EM DISTURBANCES
(the defined term ESSENTIAL PERFORMANCE need not be used). Table 1:
Guidance and manufacturers declaration electromagnetic emissions:
Emissions test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Group 1 Group B Not application Not application 54 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 54 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 54 17.05.21 16:40 17.05.21 16:40 Table 2:
Guidance and manufacturers declaration electromagnetic immunity:
Immunity test IEC 60601-2 test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Electrical fast transient / burst IEC 61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50Hz / 60Hz) magnetic field IEC 61000-4-8 Conduced RF IEC61000-4-6 Radiated RF IEC61000-4-3 30 A / m 50 Hz / 60 Hz 30 A / m 50 Hz / 60 Hz Not applicable Not applicable 10 V / m 80 MHz2,7 GHz 80 % AM at 1 kHz 10 V / m 80 MHz2,7 GHz 80 % AM at 1 kHz 55 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 55 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 55 17.05.21 16:40 17.05.21 16:40 Immunity test IEC 60601-2 test level Compliance level NOTE UT is the a.c. mains voltage prior to application of the test level. 56 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 56 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 56 17.05.21 16:40 17.05.21 16:40 Table 3:
Guidance and manufacturers declaration -
electromagnetic immunity:
Test Fre-
quency Band
(MHz) Service Radiated RF IEC61000-4-3
(Test specifica-
tions for ENCLOSURE PORT IMMU-
NITY to RF wireless com-
munications equipment) 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 57 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 57 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 57 17.05.21 16:40 17.05.21 16:40 Test Fre-
quency Band
(MHz) Service Radiated RF IEC61000-4-3
(Test specifica-
tions for ENCLOSURE PORT IMMU-
NITY to RF wireless com-
munications equipment) 2450 24002570 17001990 GSM 1800;
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 1720 1845 1970 5240 5500 5785 58 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 58 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 58 17.05.21 16:40 17.05.21 16:40 Table 3:
Guidance and manufacturers declaration -
electromagnetic immunity:
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 com-
munications equipment) 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 59 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 59 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 59 17.05.21 16:40 17.05.21 16:40 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 com-
munications equipment) 2 0.3 28 2 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 60 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 60 366723_2101_V3.0_silv_Blutdruckmessgeraet_Content_US.indd 60 17.05.21 16:40 17.05.21 16:40
1 | Label & label location | ID Label/Location Info | 1.65 MiB | July 07 2021 |
Label NOTICE:
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. FCC ID: OU9TMB1891HJ Linie nur fr Positionierung Line only for position Denition:
Gre/Size:
Material:
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1 | FCC agent authorization letter | Cover Letter(s) | 69.35 KiB | July 07 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd Date: 06/29/2021 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:
I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:
a) b) c) d) e) f) comply with the relevant provisions of the certification program;
make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;
make claims regarding certification only in respect of the scope for which certification has been granted;
do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;
upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;
use certification only to indicate the products are certified as being in conformity with specified standards;
g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;
h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;
i) keep a record of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;
j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;
k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:
Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Vince Zeng Title of Person: R&D Director Address: Zone A, No.105 ,Dongli Road,Torch Development District Zhongshan Guangdong 528437 China
1 | FCC confidentiality request letter | Cover Letter(s) | 75.67 KiB | July 07 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: OU9TMB1891HJ To Whom It May Concern:
Schematic Diagram Block Diagram Theory of Operation BOM List Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Vince Zeng Title of Person: R&D Director Address: Zone A, No.105 ,Dongli Road,Torch Development District Zhongshan Guangdong 528437 China Date: 06/29/2021
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-07-07 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-07-07
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
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1 | FCC Registration Number (FRN) |
0021999248
|
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1 | Physical Address |
Zone A, No.105,Dongli Road Torch Development District
|
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1 |
Zone A, No.105,Dongli Road
|
|||||
1 |
Zhongshan, Guangdong, N/A
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1 |
China
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app s | TCB Information | |||||
1 | TCB Application Email Address |
L******@ul.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 | Grantee Code |
OU9
|
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1 | Equipment Product Code |
TMB1891HJ
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
V**** Z********
|
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1 | Title |
RA Director
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
g******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
UL Verification Services Guangzhou Co., Ltd
|
||||
1 | Name |
E****** Y****
|
||||
1 | Physical Address |
Building 10, Innovation Technology Park
|
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1 |
Dongguan, 523808
|
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1 |
China
|
|||||
1 | Telephone Number |
+8676********
|
||||
1 |
e******@ul.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Pressure Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
UL Verification Services (Guangzhou) Co., Ltd.
|
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1 | Name |
S******** G******
|
||||
1 | Telephone Number |
+86 0********
|
||||
1 |
S******@ul.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0007000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC