SBC 15 - Blood pressure monitor SANITAS - Free user manual and instructions

USER MANUAL SBC 15 SANITAS

Blood pressure monitor with cuff

Instructions for use Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

1. Getting to know your device

Check that the device packaging has not been tampered with and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories 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 Ser- vices address. The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your blood pressure, save the measurements and display the development of the measurements. You are also warned of possible existing cardiac arrhythmia. The recorded values are classified and evaluated graphi- cally. ENGLISH

1. Getting to know your device .....................................18

7. Saving, displaying and deleting measured values ..29

8. Error messages/troubleshooting ............................. 30

9. Cleaning and storing the device and cuff ................31

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: Attention Product information Note on important information Observe the instructions Read the instructions before start- ing work and/or operating devices or machines Isolation of applied parts Type BF Galvanically isolated applied part (F stands for “floating”); meets the requirements 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 EC Directive – WEEE Separate the packaging elements and dispose of them in accordance with local regulations.

Marking to identify the packaging material. A = Material code, B = Material number: 1-7 = Plastics, 20-22 = Paper and cardboard Manufacturer Storage/Transport Permissible storage and transport tem- perature and humidity Operating Permissible operating temperature and humidity IP22 IP class Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle 19S

Serial number Item number Medical device CE labelling This product satisfies the require- ments of the applicable European and national directives. Separate the product and packag- ing elements and dispose of them in accordance with local regulations. Notes on use

In order to ensure comparable values, always measure your blood pressure at the same time of day.

Do not take a measurement within 30 minutes of eat- ing, drinking, smoking or exercising.

Before the initial blood pressure measurement, make sure always to rest for about 5 minutes.

Furthermore, if you want to take several measure- ments in succession, make sure always to wait for at least 1 minute between the individual measurements.

Repeat the measurement if you are unsure of the measured value.

The measured values taken by you are for your infor- mation only – they are no substitute for a medical examination. Discuss the measured values with your doctor and never base any medical decisions on them (e.g. medicines and their administration).

Using the blood pressure monitor outside your home environment or whilst on the move (e.g. whilst travel- ling in a car, ambulance or helicopter, or whilst under- taking physical activity such as playing sport) can influence the measurement accuracy and cause incor- rect measurements.

Do not use the blood pressure monitor on newborns, pregnant women or patients with pre-eclampsia.

In the case of restricted circulation on the arm as a result of chronic or acute vascular diseases (including vascular constriction), the accuracy of the wrist meas- urement is limited. In this case you should avoid using an upper arm blood pressure monitor.

This device is not intended for use by people (includ- ing children) with restricted physical, sensory or men- tal skills or a lack of experience and/or a lack of knowl- edge, unless they are supervised by a person who has responsibility for their safety or they receive instruc- tions from this person on how to use the device. Supervise children around the device to ensure they do not play with it. 20• Cardiovascular diseases may lead to incorrect meas- urements or have a detrimental effect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhyth- mias as well as chills or shaking.

The blood pressure monitor must not be used in con- nection with a high-frequency surgical unit.

Only use the device on people who have the specified wrist measurement for the device.

Please note that when inflating, the functions of the limb in question may be impaired.

During the blood pressure measurement, the blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm.

Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.

Make sure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular or therapy, or an arteriovenous (AV) shunt.

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

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

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

The blood pressure monitor can only be operated with batteries.

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 careless use. Instructions for storage and maintenance

The blood pressure monitor is made from preci- sion and electronic components. The accuracy of the measured values and service life of the device depend on its careful handling: – Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight. – Do not drop the device. – Do not use the device in the vicinity of strong elec- tromagnetic fields and keep it away from radio sys- tems or mobile telephones.

We recommend that the batteries be removed if the device will not be used for a prolonged period of time. 21Notes on handling batteries

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

Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.

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

Protect batteries from excessive heat.

Risk of explosion! Never throw batteries into a fire.

Do not charge or short-circuit batteries.

If the device is not to be used for a relatively long period, take the batteries out of the battery compart- ment.

Use identical or equivalent battery types only.

Always replace all batteries at the same time.

Do not use rechargeable batteries!

Do not disassemble, split or crush the batteries. Instructions for repairs and disposal

Batteries do not belong in household waste. Please dispose of empty batteries at the collection points intended for this purpose.

Do not open the device. Failure to comply will invali- date the warranty.

Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.

Repairs must only be carried out by Customer Ser- vices or authorised suppliers. 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. 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 responsible for waste disposal. 22Notes on electromagnetic compatibility

The device is suitable for use in all environments listed in these instructions for use, including domestic envi- ronments.

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 dis- play/device.

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 device 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 provided 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.

6. Battery compartment lid

3. Diastolic pressure

9. Battery replacement symbol

4. Preparing for the measurement

Inserting the batteries

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

• Insert two 1.5 V 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.

• Carefully close the battery compartment lid again. If the battery replacement symbol is displayed, you can no longer perform any measurements and must replace all batteries. Battery disposal

• The empty, completely flat batteries must be disposed of through specially designated collection boxes, recy- cling points or electronics retailers. You are legally required to dispose of the batteries. 24• The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Batter contains cadmium, Hg = Battery contains mercury. Setting the hour format, date and time It is essential that you set the date and time. Otherwise, you will not be able to save your measured values cor- rectly with a date and time and access them again later. There are two different 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 the batteries into the device you will be taken to the relevant menu automatically.

• If the batteries have already been inserted: With the device switched off press and hold the START/STOP button for approx. 5 seconds. In this menu you can adjust the following settings in suc- cession: Hour format

Press and hold the START/STOP button for 5seconds or insert the batteries. The full display appears.

Select the desired hour format using the memory button M and confirm with the START/STOP button . Date The year flashes on the display.

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

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

Select the desired day with the memory button M and confirm with the START/STOP button . If the hour format is set as 12h, the day/month display sequence is reversed. 25Time The hours flash on the display.

Select the desired hour using the mem- ory button M and confirm with the START/ STOP button . The minutes flash on the display.

Select the desired minute using the mem- ory button M and confirm with the START/ STOP button . Once all the data has been set, the device switches off automatically.

5. Measuring blood pressure

Ensure the device is at room temperature before measu- ring. The measurement can be performed on the left or right wrist. Attach the cuff

Expose your wrist. Ensure that the circulation of the arm is not hindered by tight clothing or similar. Place the cuff on the inside of your wrist.

Close the cuff with the hook-and-loop fastener so that the upper edge of the device is positioned approx. 1cm underneath the heel of the hand.

The cuff must be fitted tightly around the wrist, but must not constrict. Blood pressure may vary between the right and left arm, which may mean that the measured blood pressure values are different. Always perform the measurement on the same arm. If the values between the two arms are significantly dif- ferent, please consult your doctor to determine which arm should be used for the measurement. 26Adopting the correct posture

Before the initial blood pressure measurement, make sure always to rest for about 5 minutes. Otherwise deviations can occur.

You can take the measurement while sitting or lying down. To take your blood pres- sure, make sure you are sitting comfortably with your arms and back leaning on something. Do not cross your legs. Place your feet flat on the ground. Make sure to rest your arm and move it. Always make sure that the cuff is at heart level. Otherwise significant deviations can occur. Relax your arm and the palm of your hand.

To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak.

Wait for at least 1 minute before taking another meas- urement. Performing the blood pressure measurement As described above, attach the cuff and adopt the pos- ture in which you want to perform the measurement.

Press the START/STOP button to start the blood pressure moni- tor. All displays will illuminate briefly.

• The last measured value is dis- played and the blood pressure monitor automatically begins the measurement after 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 displayed.

The systolic pressure, diastolic pressure and pulse rate measure- ments are displayed.

appears if the measurement has not been performed properly. Observe the chapter on error messages/trouble-

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

Press the START/STOP button to switch off the blood pressure monitor. The measurement is then stored in the selected user memory. If you forget to turn off the device, it will switch off auto- matically 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.

6. Evaluating results

Cardiac arrhythmia This device can identify potential disruptions of the heart rhythm when measuring and if necessary, indicates this after the measurement with the symbol

This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heart- beat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical make-up, excess stimulants, stress or lack of sleep. Arrhythmia can only be determined through an examination by your doctor. If the symbol is shown on the display after the measurement has been taken, repeat the measurement. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the measurement. If the symbol appears frequently, please consult your doctor. Self-diagnosis and treatment based on the measurements can be dangerous. Always follow your GP’s instructions. Risk indicator The measurements can be classified and evaluated in accordance with the following table. However, these standard values serve only as a general guideline, as the individual blood pressure varies in differ- ent people and different age groups etc. It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous. The classification on the display and the scale on the unit show which category the recorded blood pressure val- ues fall into. If the values of systole and diastole fall into two different categories (e.g. systole in the ’High nor- mal’ category and diastole in the ’Normal’ category), the 28graphical classification on the device always shows the higher category; for the example given this would be ’High normal’. Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Setting 3: severe hypertension ≥ 180 ≥ 110 seek medical attention Setting 2: moderate hyper

ring by doctor High normal 130 – 139 85 – 89 regular monito

ring by doctor Normal 120 – 129 80 – 84 self-monitoring Optimal < 120 < 80 self-monitoring Source: WHO, 1999 (World Health Organization)

7. Saving, displaying and deleting

measured values User memory The results of every successful measurement are stored together 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 M for approx. 2 seconds. Average values

Press the memory button M. AMAM flashes on the display. The average value of the morning measurements for the last 7 days is displayed (morning: 5.00 a.m. – 9.00 a.m.). 29Average values

Press the memory button M. PMPM flashes on the display. The average value of the evening measurements for the last 7 days is displayed (evening: 6.00 p.m. – 8.00 p.m.). Individual measured values

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

When the memory button M is pressed again, you can view your individual measurements.

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

To clear the memory of 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.

Press and hold the memory button M and the START/STOP button for 5 seconds, depending on the user memory you are in. All values of the current user memory are deleted and the device switches off.

8. Error messages/troubleshooting

In the event of errors, the error message _ appears on the display. Error messages may appear if

• the systolic or diastolic pressure could not be meas- ured (

appears on the display)

• the systolic or diastolic pressure was outside the meas- urement range ( “Hi”

“Lo” appears on the display)

• the cuff is fastened too tightly or too loosely

appears on the display) 30• the blood pressure is higher than 300 mmHg for more than 1.5 seconds ( appears on the display)

• pumping up takes longer than 180 seconds ( appears on the display)

• there is a system or unit error ( , , or appears on the display)

• the batteries are almost empty

In such cases, repeat the measurement. Ensure that you do not move or speak during the measurement. If neces- sary, reinsert or replace the batteries. Technical alarm – description Should the recorded blood pressure (systolic or diastolic) lie outside the limits specified in the section “Technical specifications”, the technical alarm will appear on the display indicating either “   ” or “ Lo Lo ”. In such cases, you should seek medical assistance and check the accuracy of your procedure. The limit values for the technical alarm are factory set and cannot be adjusted or deactivated. These alarm limit values are accorded second priority under the standard IEC 60601-1-8. The technical alarm is a non-locking alarm and must not be reset. The signal shown on the display will disappear automatically after about 8 seconds.

9. Cleaning and storing the device and

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

Do not use any cleaning agents or solvents.

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

If you store the device and cuff, do not place heavy objects on the device and cuff. Remove the batteries.

10. Technical specifications

Model No. SBC 15 Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist Measurement range Cuff pressure 0 – 300mmHg, Systolic 60-260mmHg, Diastolic 40-199mmHg, Pulse 40 –180 beats/minute Display accuracy Systolic ± 3mmHg, Diastolic ± 3mmHg, Pulse ± 5 % of the value shown 31Measurement inac- curacy Max. permissible standard devia- tion according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 83.8mmx W59.9mmx H29.4mm Weight Approximately 92g (without batter- ies, with cuff) Cuff size 140 to 195mm Permissible operat- ing conditions + 10°C to +40°C, ≤85% relative humidity (non-condensing) Permissible storage conditions -20°C to +50 °C, ≤ 85% relative humidity, 800 – 1050hPa ambient pressure Power supply 2 x 1.5V AAA batteries Battery life For approx. 170 measurements, depending on levels of blood pres- sure and pump pressure Classification Internal supply, IP22, no AP or APG, continuous operation, appli- cation part type BF Technical information is subject to change without notifi- cation to allow for updates.

This device complies with European Stand- ard EN60601-1-2 (in accordance with CISPR11, EN61000-4-2, EN61000-4-3, EN61000-4-8 ) and is subject to particular precautions with regard to electro- magnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit.

The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN1060-1 (Non-invasive sphygmomanometers – Part1: General requirements), EN1060-3 (Non-invasive sphygmoma- nometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring sys- tems) and IEC80601-2-30 (Medical electrical equip- ment – Part 2 – 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).

The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address. 32Subject to error and changes

11. Warranty / Service

Further information on the guarantee and guarantee con- ditions can be found in the guarantee leaflet supplied. 33Contenu