SBC 22 - Blood pressure monitor SANITAS - Free user manual and instructions

USER MANUAL SBC 22 SANITAS

Table of contents Read these instructions for use carefully and keep them for later use. Make them accessible to other users and note the information they contain.

1. INCLUDED IN DELIVERY

Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or acces- sories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Service address. 1x Blood pressure monitor with cu 2x 1.5 V LR03 AAA batteries 1x Storage box 1x Instructions for use

222. SIGNS AND SYMBOLS

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories: WARNING Warning notice indicating a risk of injury or damage to health IMPORTANT Safety note indicating possible damage to the device/accessory Product information Important information to note Observe the instructions Read the instructions before starting work and/or operating devices or machines Isolation of applied parts Type BF Galvanically isolated application part (F stands for “floating”); meets the require- ments for leakage currents for type B Direct current The device is suitable for use with direct current only Disposal in accordance with the Waste Electrical and Electronic Equipment ECDi- rective – WEEE Do not dispose of batteries containing haz- ardous substances with household waste

PAP Dispose of packaging 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 Manufacturer 23Temperature limit The temperature limit values to which the medical device can safely be exposed are indicated Humidity, limit Indicates the humidity range to which the medical device can safely be exposed IP22 IP class Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle

Serial number CE labelling This product satisfies the requirements of the applicable European and national directives.

Purpose The blood pressure monitor is intended for the fully automat- ic, non-invasive measurement of arterial blood pressure and pulse values on a wrist with a wrist circumference of 14 cm to 19.5 cm. It is intended for use indoors and by adults only. Target group It is designed for self-measurement by adults in the home en- vironment and is suitable for users whose wrist circumference is within the range printed on the cu. Indication/clinical benefits The user can record their blood pressure and pulse values quickly and easily using the device. The recorded values are classified according to internationally applicable guidelines and evaluated graphically. The device saves the recorded measurements and can also output average values of previ- ous measurements.

• Do not use the blood pressure monitor on newborns, chil- dren or pets.

• People with restricted physical, sensory or mental skills should be supervised by a person responsible for their 24safety and receive instructions from this person on how to use the device.

• If you have any of the following conditions, it is essential you consult your doctor before using the device: irregu- lar heartbeat, circulatory problems, diabetes, pregnancy, pre-eclampsia, hypotension, chills, shaking

• People with pacemakers or other electrical implants should consult their doctor before using the device.

• The blood pressure monitor must not be used in connec- tion with a high-frequency surgical unit.

• Do not use the cu on people who have undergone a mastectomy.

• Do not place the cu over wounds as this may cause further injury.

• Make sure that the cu is not placed on a wrist in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular therapy, or an arteriovenous (AV) shunt. General warnings

• The measurements taken by you are for your information only – they are no substitute for a medical examination! Discuss the measured values with your doctor and never make your own medical decisions based on them (e.g. regarding dosages of medicines).

• The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or incorrect use.

• Using the blood pressure monitor outside your home en- vironment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physi- cal activity such as playing sport) can influence the meas- urement accuracy and cause incorrect measurements.

• Cardiovascular diseases may lead to incorrect measure- ments or have a detrimental eect on measurement ac- curacy.

• Do not use the device at the same time as other medical electrical devices (ME equipment). This could lead to a malfunction of the measuring device and/or an inaccurate measurement.

• Do not use the device outside of the specified storage and operating conditions. This could lead to incorrect measurements.

• Only use the cus included in delivery or cus described in these instructions for use for the device. Using another cu may lead to measurement inaccuracies. 25• Note that when inflating the cu, the functions of the limb in question may be impaired.

• Do not perform measurements more frequently than nec- essary. Due to the restriction of blood flow, some bruising may occur.

• During the blood pressure measurement, the blood cir- culation must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cu from the wrist.

• Place the cu on your wrist only. Do not place the cu on other parts of the body.

• Small parts may present a choking hazard for small chil- dren if swallowed. They should therefore always be su- pervised. General precautions

• The blood pressure monitor is made from precision and electronic components. The accuracy of the measure- ments and service life of the device depend on its careful handling.

• Protect the device from impacts, moisture, dirt, marked temperature fluctuations and direct sunlight.

• Ensure the device is at room temperature before measur- ing. If the measuring device has been stored close to the maximum or minimum storage and transport tempera- tures and is placed in an environment with a temperature of 20°C, it is recommended that you wait approx. 2 hours before using the measuring device.

• Do not drop the device.

• Do not use the device in the vicinity of strong electro- magnetic fields and keep it away from radio systems or mobile telephones.

• We recommend that the batteries be removed if the de- vice will not be used for a prolonged period of time. Measures for handling batteries

• If your skin or eyes come into contact with battery fluid, rinse the aected areas with water and seek medical assistance.

• Choking hazard! Small children may swallow and choke on batteries. Therefore, batteries should be stored out of the reach of small children.

• Risk of explosion! Do not throw batteries into a fire.

• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

• Do not disassemble, open or crush the batteries. 26• Observe the plus (+) and minus (-) polarity signs.

• Protect batteries from excessive heat.

• Do not charge or short-circuit the batteries.

• If the device is not to be used for a long period of time, remove the batteries from the battery compartment.

• Use identical or equivalent battery types only.

• Always replace all batteries at the same time.

• Do not use rechargeable batteries. 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/de- vice.

• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the de- vice in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.

• The use of accessories other than those specified or pro- vided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.

• Failure to comply with the above can impair the perfor- mance of the device.

5. DEVICE DESCRIPTION

The corresponding drawings are shown on page 3.

Battery compartment lid 27Information on the display: The corresponding drawings are shown on page 3.

Calculated pulse rate

Battery replacement symbol

• Remove the battery compartment lid on the left side of the device

• Insert two 1.5 V AAA micro (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings

. Do not use rechargeable batteries.

• Close the battery compartment lid again carefully. If the battery replacement symbol is displayed, you can no longer perform any measurements and must replace all batteries. Adjusting the settings You must make sure that the device has the correct settings before use in order to be able to make full use of all functions. Only by doing so can your measurements with associated date and time be saved and accessed later by you. There are two dierent ways to access the menu from which you can adjust the settings:

• Before initial use and after each time you replace the battery: When inserting batteries into the device, you will be taken to the relevant menu automatically.

• If the batteries have already been inserted: With the device switched o press and hold the START/ STOP button for approx. 5 seconds. In this menu you can adjust the following settings in succes- sion: Hour format Date Time 28Hour format The hour format flashes on the display.

• Select the desired hour format using the mem- ory button and confirm with the START/ STOP button . Date The year flashes on the display.

• Select the desired year using the memory button and confirm with the START/ STOP button . The month flashes on the display.

• Select the desired month with the memory button and confirm with the START/STOP button . The day flashes on the display.

• Select the desired day using the memory button and confirm with the START/STOP button . If the hour format is set as 12h, the day/month dis- play sequence is reversed. Time The hours flash on the display.

• Select the desired hour using the memory button and confirm with the START/STOP button . The minutes flash on the display.

• Select the desired minute using the memory button and confirm with the START/STOP button . Once all the data has been set, the device switches o au- tomatically.

• Fundamentally, blood pressure can be measured on both wrists. Certain deviations between the measured blood pressure on the right wrist and left wrist are due to physiological causes and completely normal. You should always perform the measurement on the wrist with the highest blood pressure values. Before starting self-meas- urement, consult your doctor in this regard. From this point on, always take measurements on the same wrist. 29• The device may only be operated with the cu attached when supplied. Before using the device, the user should check the fit of the cu and, in doing so, ensure that their wrist circumference is within the range printed on the cu.

• Uncover your wrist. Ensure that the circulation of the wrist is not hindered by tight clothing or similar.

• Now place the cu on the wrist so that the palm of your hand and the device display are facing upwards B 1

• Position the cu so that there is a distance of 1.0 – 1.5 cm between it and the heel of your hand B 2

• Now fasten the cu tightly around your wrist using the hook-and-loop fastener. Make sure that it is tight but that it does not cut into your wrist B 3

Adopting the correct posture

• To carry out a blood pressure measurement, make sure you are sitting upright and comfortably. Lean back so your back is supported.

• Place your arm on a surface

• Place your feet flat on the ground next to one another.

• The cu must be level with your heart.

• Stay as still as possible during the measurement and do not speak. Performing the blood pressure measurement Measurement Press the START/STOP button to start the blood pressure monitor. All display elements are briefly displayed.

• Press the START/STOP button to start the blood pressure monitor . All displays will illuminate briefly.

• The last measured value is displayed and the blood pressure monitor auto- matically begins the measurement af- ter 3 seconds. You can cancel the measurement at any time by pressing the START/STOP button . As soon as a pulse is found, the pulse symbol will be dis- played.

• Systolic pressure, diastolic pressure and pulse measurements are dis- played. 30• _ appears if the measurement has not been performed properly. Observe the chapter on error mes- sages/troubleshooting in these instructions for use and repeat the measurement.

• Now select the desired user memory by pressing the memory button . If you do not select a user memory, the measurement is stored in the most re- cently used user memory. The relevant or symbol appears on the display.

• Press the START/STOP button to switch o the blood pressure monitor. The measurement is then stored in the selected user memory. If you forget to turn o the device, it will switch o automati- cally after approx. 1 minute. In this case too, the value is stored in the selected or most recently used user memory. Wait for at least 1 minute before taking another measurement. Evaluating the results General information about blood pressure

• Blood pressure is the force with which the bloodstream presses against the arterial walls. Arterial blood pressure constantly changes in the course of a cardiac cycle.

• Blood pressure is always stated in the form of two values: - The highest pressure in the cycle is called systolic blood pressure. This arises when the heart muscle contracts and blood is pumped into the blood vessels. - The lowest is diastolic blood pressure, which is when the heart muscle has completely stretched back out and the heart fills with blood.

• Fluctuations in blood pressure are normal. Even during repeat measurements, considerable dierences between the measured values may occur. One-o or irregular measurements therefore do not provide reliable informa- tion about the actual blood pressure. Reliable assess- ment is only possible when you perform the measure- ment regularly under comparable conditions. Risk indicator The World Health Organization (WHO) has defined the in- ternationally recognised classification for the evaluation of measured blood pressure values listed in the table below: 31Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Level 3: severe hyperten- sion ≥ 180 ≥ 110 Seek medical attention Level 2: moderate hyper- tension 160 – 179 100 – 109 Seek medical attention Level 1: mild hypertension 140 – 159 90 – 99 Regular monitor- ing by doctor High normal 130 – 139 85 – 89 Regular monitor- ing by doctor Normal 120 – 129 80 – 84 Self-monitoring Optimal < 120 < 80 Self-monitoring Source: WHO, 1999 (World Health Organization) The risk indicator (the arrow in the display and the associ- ated scale on the device) shows which category the recorded blood pressure values fall into. If the measured values are in two dierent classifications (e.g. systole in the high normal category and diastole in the normal category), the risk indica- tor then always shows you the higher category – “high nor- mal” in the example described. Please be aware that these standard values can only serve as a general guideline, as the individual blood pressure varies in dierent people and dierent age groups, etc. Furthermore, it must be noted that measurements taken your- self while at home are generally lower than those that are taken by the doctor. For this reason, it is important that you regularly consult your doctor for advice. Only they are able to give you your personal target values for controlled blood pressure – in particular if you receive medicinal therapy. Irregular heartbeat This device can identify any irregular heartbeat disturbances as part of the analysis of your recorded pulse signal during blood pressure measurement. In this case, after the measure- ment, the device will indicate any irregularities in your pulse by displaying the symbol in the display. This can be an indicator for irregular heartbeat. If the symbol appears on the display after the measure- ment, the measurement must be repeated as the measure- ment accuracy may be impaired. To assess your blood pres- sure, only use the results that have been recorded without corresponding irregularities in your pulse. If the symbol appears frequently, please consult your doctor. Only they can establish the existence of an arrhythmia during a checkup, using their means of diagnosis. 32Saving, accessing and deleting measured values User memory The results of every successful measurement are stored to- gether with the date and time. The oldest measurement is overwritten in the event of more than 60 measurements.

flashes on the display. The average value of all saved measured values in this user memory is displayed. To change the user memory, press and hold the memory button for approx. 2 seconds. Average values

• Press the memory button . AMAM flashes on the display. The average value of the morning meas- urements for the last 7 days is displayed (morning: 5 a.m. – 9 a.m.).

PMPM flashes on the display. The average value of the evening meas- urements for the last 7 days is displayed (evening: 6 p.m. – 8 p.m.). Individual measured values

• When you press the memory button again, the last individual measurement is displayed (in this example, measurement 03).

• When you press the memory button again, you can view your individual measured values.

• To switch the device o again, press the START/STOP button . You can exit the menu at any time by pressing the START/ STOP button . Deleting measured values

• To clear the relevant user memory, you must first select a user memory.

• Start the retrieval of the average measured values. A flashes on the display and the average value of all saved measured values in this user memory is displayed. 33• Press and hold the memory button and the START/ STOP button for 5 seconds, depending on the user memory you are in. All values of the current user memory are delet- ed and the device switches o.

8. CLEANING AND MAINTENANCE

• Clean the device and cu carefully using a slightly damp cloth only.

• Do not use any cleaning agents or solvents.

• Under no circumstances hold the device and cu under water, as this can cause liquid to enter and damage the device and cu.

• If you store the device and cu, do not place heavy ob- jects on the device and cu. Remove the batteries.

The systolic or diastolic pres- sure could not be measured. Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement.

The systolic or diastolic pres- sure is outside of the measure- ment range. Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement. If the message is displayed again, you should seek medical assistance and check the accuracy of your procedure.

The cu was not attached cor- rectly. Please observe the infor- mation in the chapter on “Attaching the cu”. 34Error message Possible cause Solution The blood pres- sure is higher than 300mmHg for more than 1.5seconds. Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement. If the message is displayed again, you should seek medical assistance and check the accuracy of your procedure. Pumping up takes longer than 180sec- onds. Please take another meas- urement to check whether the cu can be correctly inflated. Please observe the infor- mation in the chapter on “Attaching the cu”.

There is a system or device error. Please contact customer service. Error message Possible cause Solution The batteries are almost empty. Insert new batteries into the device.

Repairing and disposing of the device

• Do not repair or adjust the device yourself. Proper opera- tion can no longer be guaranteed in this case.

• Do not open the device. Failure to comply with this in- struction will void the warranty.

• Repairs must only be carried out by Customer Services or authorised retailers. Before making a claim, please check the batteries first and replace them if necessary.

• For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the device at a suitable local collection or recycling point in your country. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities re- sponsible for waste disposal. 35Disposing of the batteries

• Batteries must not be disposed of in the household waste. They may contain poisonous heavy metals and are subject to special refuse treatment.

• The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury.

11. TECHNICAL SPECIFICATIONS

Type SBC 22 Model SBC 15 Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist Measurement range Cu pressure 0 – 300 mmHg, systolic 60 – 260 mmHg, diastolic 40 – 199 mmHg, pulse 40 – 180 beats/minute Display accuracy Systolic ± 3 mmHg, diastolic ± 3 mmHg, pulse ± 5% of the value shown Measurement uncer- tainty Max. permissible standard deviation according to clinical testing: systolic 8 mmHg / diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 84 mm x W 60 mm x H 29 mm Weight Approx. 92 g (without batteries, with cu) Cu size 140 to 195 mm Permissible operating conditions + 10°C to +40°C, ≤85% relative humidity (non-condensing) Permissible storage conditions -20°C to +50°C, ≤ 85% relative humidity, 800 –1050 hPa ambient pressure Power supply 2 x 1.5-V AAA batteries Battery life For approx. 170 measurements, de- pending on levels of blood pressure and inflation pressure Classification Internal supply, IP22, no AP or APG, continuous operation, application part type BF 36The serial number is located on the device or in the battery compartment. Technical information is subject to change without notification to allow for updates.

• This device complies with the European stand- ard EN 60601-1-2 (compliance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special precautionary measures with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.

• The device complies with the EU Medical Devices Di- rective 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN 1060-1 (Non-invasive sphygmomanometers – Part 1: General requirements), EN 1060-3 (Non-invasive sphygmoma- nometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphyg- momanometers).

• The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If the device is used for commercial medical purposes, it must be regularly tested for accuracy by ap- propriate means. Precise instructions for checking accu- racy may be requested from the service address.

12. WARRANTY/SERVICE

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied. Subject to errors and changes 37FRANÇAIS