IAN 366722 - Uncategorized SILVERCREST - Free user manual and instructions

USER MANUAL IAN 366722 SILVERCREST

PRESSURE MONITOR Instructions for use and safety notes

settings .......Page 65 Activating and deactivating Bluetooth

The CE mark certifies compliance with the basic requirements of Medical Devices Directive 93/42/EEC.

mproper disposal of batteries can harm the envi- ronment! Do not dispose of batteries containing harmful substances in household waste. IP21 Device protected against foreign matter ≥12.5 mm and against water falling vertically Dispose of the packaging and the blood pressure monitor in an environmentally friendly manner!

Marking to identify the packaging material. A = material abbreviation, B = material number: 1‒6 = plastics, 20‒22 = paper and cardboard. Data transfer via Bluetooth

low energy technology Medical device51 GB/IE Upper Arm Blood Pressure Monitor Introduction Please make yourself familiar with the upper arm blood pressure monitor before preparing it for use or using it for the first time. Please carefully read the following instructions for use and the important safety notes. Failure to observe the notes may result in per- sonal injury or property damage. The product must only be used as described in these instructions for use and for the specified fields of application. Keep these instructions for use in a safe place. If you pass the upper arm blood pres- sure monitor on to anyone else, please ensure that you also pass on all the documentation. 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 22 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 pro- gression and average of these measurements. The recorded measurements are classified and evaluated graphically.52 GB/IE A symbol in the display also warns of irregular heartbeat. If this symbol frequently lights up in the display after the meas- urement, please consult your doctor for diagnosis. Any use other than previously mentioned or any product modifica- tion 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 meas- urement 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 meas- urement values and can also provide average values of pre- vious measurements. The data recorded can support health service providers when diagnosing and treating blood53 GB/IE pressure problems and thus contribute to the long-term mon- itoring of the user’s health. Indication If the user has hypertension or hypotension, they can moni- tor their blood pressure, pulse values and irregular heartbeat in a home environment. However, the user does not have to suffer from hypertension or irregular heartbeat to use the device. Contraindication 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. People with limited physical, sensory or mental abilities should be supervised by a person responsible for their safety and adhere to this person’s instructions for using the device. Before using the device under any of the following cir- cumstances, it is absolutely necessary that you consult a doctor: cardiac arrhythmias, circulation problems, diabetes, hypotension, chills, tremors.54 GB/IE Do not use the product in conjunction with a high-fre- quency surgical unit. 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. 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. Do not use the device on people with allergies or sensi- tive skin. Parts description

Connection for cuff plug

Battery compartment55 GB/IE Display indicators

Symbol for irregular heartbeat Symbol for pulse

Memory display: Average value (A), morning (AM), evening (PM), number of the memory space

Symbol for replace battery

Symbol for Bluetooth

Cuff position control Scope of delivery 1 Upper arm blood pressure monitor 1 Upper arm cuff (material no. 164.385 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 pouch56 GB/IE Technical data Type: SBM 69 Measuring method: Oscillometric, non-invasive blood pressure measurement on the upper arm Measurement range: Cuff pressure: 0–299 mmHg, systolic: 60–230 mmHg diastolic: 40–130 mmHg pulse: 40–199 beats per minute Display accuracy: systolic ± 3 mmHg, diastolic ± 3 mmHg, pulse ± 5 % of the displayed value Measurement uncertainty: max. permissible standard deviation according to clinical testing: systolic 8 mmHg / diastolic 8 mmHg Memory: 2 x 100 memory spaces Dimensions: L 134.5 mm x W 100 mm x H 51.0 mm Cuff: suitable for an arm circumference between 22 and 42 cm Weight: approx. 395 g (with cuff, without batteries) Permissible operating conditions: +5 °C to +40 °C, 15 % to 90 % relative humidity (non-condensing), 700‒1060 hPa ambient pressure57 GB/IE Permissible storage conditions: -20 °C to +60 °C, ≤ 93 % relative humidity (not condensing), 700‒1060 hPa ambient pressure Power supply: 4 x 1.5 V AAA batteries Product expected lifespan: 5 years Battery life: Approx. 225 measurements, depend- ing on blood pressure level and infla- tion pressure / Bluetooth

transfer Classification: Internal supply, IP21, no AP or APG, continuous operation, applied part Type BF Data transfer via Bluetooth

low energy technology: The product uses Bluetooth

low energy technology, frequency band 2.402‒2.480 GHz, maximum transmission power radiated in the frequency band < 4 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.lidl58 GB/IE System requirements of the „HealthForYou“ web version: - 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; Android

from 4.0 Technical specifications subject to change without notice due to updates. Warnings and safety notes General warnings 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)! 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.59 GB/IE 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 impact the accuracy of the measurement and lead to measurement errors. Cardiovascular system diseases may result in incorrect measurements and/or impairments to the device’s measurement 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. Do not use the device outside of the stated storage and operating conditions. This could lead to incorrect meas- urement results. Only use the cuffs supplied with this device or described in these instructions for use. Using another cuff can lead to inaccurate measurements. 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. 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. Only place the cuff on the upper arm. Do not place the cuff on other body parts.60 GB/IE The air tube poses a risk of strangulation for infants. Furthermore, the small parts the product contains pre- sent 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. Do not expose the device to static electricity. Always ensure that no static electricity is coming off of you before you operate the device. 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. General precautions Attention! Potential damage to the device. The sphyg- momanometer is made up of precision components and electronic components. The accuracy of the measurements61 GB/IE and the service life of the device depend on the device being used with a due amount of care. 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 20 °C, it is recommended that you wait approx. 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 suf- ficient. When in doubt, do not use and contact the ser- vice department or an authorised retailer. Do not use additional parts not recommended or sold as compo- nents 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.62 GB/IE Battery safety information DANGER TO LIFE! Keep batteries out of the reach of children. Seek immediate medical attention if swallowed! EXPLOSION HAZARD! Never recharge disposable batteries. Never short-circuit and / or open batteries. The battery may overheat, ignite or explode. Never throw batteries into fire or water. Do not exert mechanical stress on batteries. Risk of battery leakage Avoid extreme conditions and temperatures which may affect batteries, e.g. radiators / direct sunlight. If batteries have leaked, avoid contact with skin, eyes and mucous membranes with the chemicals! Flush im- mediately the affected areas with fresh water and seek medical attention! WEAR PROTECTIVE GLOVES! Leaked or damaged batteries can cause burns on con- tact with the skin. Therefore wear suitable safety gloves in this case. In the event of a battery leak, immediately remove the batteries from the product to prevent damage. Only use the same type of batteries. Do not mix old and new batteries! Remove the batteries if the product will not be used for an extended period.63 GB/IE Risk of product damage Only use the specified battery type! Insert the batteries according to the polarity marking (+) and (-) on the battery and the product. Clean the contacts on the battery and inside the battery compartment with a dry cloth before inserting the battery! Immediately remove drained batteries from the product. Do not use rechargeable batteries. 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 de- vice 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-64 GB/IE 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. 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

(fig. C). Insert the four type 1.5 V AAA (Alkaline type LR03) batteries (with the correct polarity) into the device (fig. C). Please note the marking inside the battery compartment. Carefully close the battery cover on the battery com- partment

Do not use rechargeable batteries. Note: if the change battery indicator

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, time65 GB/IE format and 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 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:66 GB/IE 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

pressed for approx. 5 seconds. Now proceed as follows: The time format will flash. Use the function buttons -/+

to set the format to 12-hour or 24-hour. Press the SET button

to confirm. The year will flash. Use the function buttons - / +

to set the year. Press the SET button

to set the month. Press the SET button

to confirm. Configure the day, hour and minute consecutively as described above. Press the SET

button to confirm each entry. 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

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

.67 GB/IE Activating and deactivating Bluetooth

function at any time, independently of the other settings. Proceed as follows: With the device switched off, briefly press the settings button SET

. You will now see the Bluetooth

Confirm your selection using the settings button SET

The device will then automatically switch off. 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.68 GB/IE 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. Attaching the cuff ATTENTION! Only use the device with the original cuff. The cuff is suitable for an upper arm circumference of between 22 and 42 cm. The correct fit should be checked before the measurement is taken using the index markings described below.69 GB/IE Place the cuff

on a bare upper arm (fig. D). The blood flow of the arm should not be constricted by clothing etc. which is too tight. Position the cuff

on the upper arm so the lower edge is 2–3 cm up from the elbow and over the artery. The cuff tubing

points towards the middle of the palm. Place the free end of the cuff

closely, but not too tightly, around the arm and close the Velcro strip. The cuff

should not be too tight (fig. E). Check that two fingers can still fit beneath the cuff

(fig. F). 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 (Fig. G). Now insert the cuff tubing

into the connector (fig. H). 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

is at the same level as the heart (fig. I‒K).70 GB/IE Sit comfortably for the blood pressure measurement. Recline your back and arms. Do not cross your legs. Put your feet flat on the ground. In order not to falsify the measurement result, it is impor- tant 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 button

. The most recently selected user memory will flash in the display

to select the desired user memory. Confirm your selection by pressing the START / STOP button

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.71 GB/IE Start the blood pressure monitor using the START / STOP button

and select the desired user memory as described in the Chapter „Selecting a memory“. 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

, the blood pressure monitor auto- matically begins measuring by inflating the cuff. The meas- urement 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. 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

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!72 GB/IE Transferring measurements via Bluetooth

You have the option of transferring the measured values and values saved on your device to your smartphone using 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:73 GB/IE Manual transfer Go to save mode (see “Saving, requesting and deleting measurements”). As soon as the average value of all meas- urements 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

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 display 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 systolic74 GB/IE 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 meas- urements 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

has been correctly positioned, the symbol

will appear in the display

during inflation. It will stay there until the measurement has successfully been taken and will then be shown together with the recorded values. Introduction of cardiac arrhythmia This device can identify any irregular heartbeat disorders and, if necessary, indicates this after the measurement process75 GB/IE with the symbol . This can be an indicator for irregular heartbeat. 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 is 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. If the symbol is displayed repeatedly, contact your doctor. Self-diagnosis and self-treatment on the basis of measurement results can be dangerous. Follow your doctor‘s instructions. Risk indicator In accordance with the guidelines / definitions provided by the World Health Organisation (WHO) and the latest find- ings, the measurement results can be classified and evalu- ated according to the following table:76 GB/IE Range of blood pressure values Risk in- dicator colour Systole (in mmHg) Diastole (in mmHg) Remedies Stage 3: severe hypertension red ≥ 180 ≥ 110 seek medical attention Stage 2: moderate hypertension orange 160–179 100–109 seek medical attention Stage 1: mild hyper- tension yellow 140–159 90–99 regular monitoring by a doctor High, normal green 130–139 85–89 regular monitoring by a doctor Normal green 120–129 80–84 Self-monitor Ideal green < 120 < 80 Self-monitor Source: WHO, 1999 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 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 classified as dangerous. The bar chart on the display and the scale on the device state which range the blood pressure measured is in.77 GB/IE If the systole and diastole values are in two different ranges (i.e. systole is “high, normal” and diastole is “normal”) the graphic categorisation on the device will always show the higher range i.e. in the above example this would be “high, normal”. Saving, requesting and deleting measurements The results of each successful measurement are saved together with the date and time. If there are over 100 meas- urement values, the oldest measurement value will be over- written. With the device switched off, press the START / STOP button

to select the desired user memory

Confirm your selection by pressing the memory button

and an average of all the saved measurements in the selected user memory will be shown. Press the memory button M

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

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 meas- urement will be displayed with the date and time.78 GB/IE Press the START / STOP button

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

when the device is switched off. The average value of all measurements will appear on the display. Next to this, “A” and the Bluetooth

pressed simultaneously for 5 seconds. After successful deletion, “CL 00” will appear in the display. The data has been deleted. 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

. You will then be in the most recently selected user memory. „A“ will flash in the display

Hold down both function buttons -/+

at the same time for approx. 15 seconds, until „CL ALL“ appears in the display

. Now all of the data saved on the de- vice will be deleted and the device will be restored to its factory settings. Cleaning and care ATTENTION! Possible property damage! Never hold the product under water as liquid could enter the prod- uct and damage it. Clean the device and cuff

carefully using a slightly damp cloth. Do not use cleaners or solvents. Storage ATTENTION! Possible property damage! Do not place any heavy objects on the device and cuff

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

Store the product in a dry location (relative humidity ≤ 93 %). High humidity can shorten the service life or80 GB/IE damage the product. Store the product in a location with ambient temperatures between -20 °C and +60 °C. Troubleshooting Trouble- shooting Problem Solution Er1 The pulse cannot be measured correctly. Repeat the measure- ment process. Be sure not to move or talk. Er2 You have been talking or moving during the measurement process. Er3 The cuff was attached too tightly or too loosely. Er4 An error occurred during the measurement process. Er5 The pump-up pressure

higher than 300 mmHg

the blood pressure meas- urement falls outside of the measuring range. Er6 The batteries are almost dead. Reinsert the batteries or replace them with new batteries.

7 Data cannot be sent via Bluetooth

on your smartphone and start the "HealthForYou" app.81 GB/IE Trouble- shooting Problem Solution

8 A device error has occurred. Repeat the measure- ment process. Be sure not to move or talk. OUT Out of measurement range - Relax for a moment. - Refasten the cuff and then measure again. - If the problem persists, contact your physician. Disposal The packaging is made entirely of recyclable materials, which you may dispose of at local recycling facilities.

Observe the marking of the packaging materials for waste separation, which are marked with abbreviations (a) and numbers (b) with following meaning: 1–6: plastics / 20–22: paper and fibreboard / 80–98: composite materials. Contact your local refuse disposal authority for more details of how to dispose of your worn-out product. To help protect the environment, please dispose of your product properly when it has reached the end of its useful life, and not in the household waste. Dispose of the product according to the EC Waste82 GB/IE Electrical and Electronic Equipment Directive - WEEE. Please contact your municipality for information on collection facilities and their opening hours. Per Directive 2006 / 66 / EC and its amendments, defective or used batteries must be recycled. Return the batteries and/or the product to a collection site. Pb Cd Hg Improper disposal of batteries can harm the environment! Never dispose of batteries in your household bin. They may contain toxic heavy metals and are subject to hazardous waste regulations. The chemical symbols of the heavy metals are: Cd = cadmium, Hg = mercury, Pb = lead. Therefore dispose of used batteries through your local collection facilities. Warranty / Service We provide a 3-year warranty covering faults in materials or manufacturing of the blood pressure monitor from the purchase date. The warranty does not cover:

• Damage caused by the customer.

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 MDSS - Medical Device Safety Service GbH, Schiffgraben 41, 30175 Hannover, Germany Imported by: Hans Dinslage GmbH, Riedlinger Str. 28, 88524 Uttenweiler, Germany www.sanitas-online.de

Notes on electromagnetic compatibility The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on. Warning: Don’t 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 EQUIPMENT291 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 manufacturer’s declaration – electromagnetic emissions: Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Group B Harmonic emissions

Not application Voltage fluctuations/ flicker emissions

Not application292 Table 2: Guidance and manufacturer’s declaration – electromagnetic immunity: Immunity test IEC 60601-2 test level Compliance level Electrostatic discharge (ESD)

Not applicable Not applicable Surge

Not applicable Not applicable Voltage dips, short interruptions and voltage variations on power supply input lines

Not applicable Not applicable Power frequency (50Hz / 60Hz) magnetic field

Not applicable Not applicable Radiated RF

is the a.c. mains voltage prior to application of the test level.293 Table 3: Guidance and manufacturer’s declaration - electromagnetic immunity: Radiated RF

(Test specifica- tions for ENCLOSURE PORT IMMU- NITY to RF wireless com- munications equipment) Test Fre- quency Band (MHz) Service 385 380‒390 TETRA

Table 3: Guidance and manufacturer’s declaration - electromagnetic immunity: Radiated RF