SANITAS SBC 15 Blood Pressure Monitor Instruction Manual

SANITAS SBC 15 Blood Pressure Monitor

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.

Getting to know your device

Check that the packaging of the Sanitas SBC 15 blood pressure monitor has not been tampered with and make sure that all the required contents are present.
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 graphically.

Important notes

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
---|---

| Note

Note on important information

| Observe the instructions for use

| Application part, type BF

| Direct current
| Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE
---|---

| Manufacturer

| Permissible storage temperature and humidity

| Permissible operating temperature and humidity

| Protect from moisture

| Serial number

0483

| The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

| Certification symbol for products that are exported to the Russian Federation and CIS countries.

Notes on use

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

• Before every measurement, relax for about five minutes.

• If you want to perform several measurements on the same person, wait five minutes between each measurement.

• Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.

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

• The measured values 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 base any medical decisions on them (e.g. medicines and their administration).

• Do not use the blood pressure monitor on newborns, pregnant women or patients with preeclampsia.

• 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 measurement is limited.
  In this case you should avoid using an upper arm blood pressure monitor.

• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Supervise children around the device to ensure they do not play with it.

• Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking.

• The blood pressure monitor must not be used in connection 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 arterio-venous (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.

• To conserve the batteries, the blood pressure monitor switches off automatically if you do not press any buttons for one minute.

• 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 precision 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 electromagnetic fields and keep it away from radio systems or mobile telephones.
• We recommend that the batteries be removed if the device will not be used for a prolonged period of time.

Notes 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.

• Observe the plus (+) and minus (-) polarity signs.

• 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 compartment.

• 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 invalidate 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 Services 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.

Unit description

1. Display
2. Wrist cuff
3. Scale for classifying the measurements
4. Start/stop button
5. Memory button M
6. Battery compartment lid

Information on the display:

1. Systolic pressure
2. Classification of measurements
3. Diastolic pressure
4. Calculated pulse value
5. Cardiac arrhythmia symbol
6. Pulse symbol
7. User memory /
8. Memory space number/memory display for average value ( ), morning (  ), evening (  )
9. Battery replacement symbol
10. Time and date
11. Release air (arrow)

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. 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.

Battery disposal

• The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
• 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
This menu allows you to set the following functions, one after another.

It is essential to set the date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later.
If you press and hold the memory button M you can set the values more quickly.

Hour format

• Press and hold the START/STOP button for 5 seconds 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.

Time

The hours flash on the display.

• Select the desired hour using the memory button M and confirm with the START/STOP button .

The minutes flash on the display.

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

Measuring blood pressure

Attach the cuff

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 different, please consult your doctor to determine which arm should be used for the measurement.

• Expose your left 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. 1 cm underneath the heel of the hand.
• The cuff must be fitted tightly around the wrist, but must not constrict.

Adopting the correct posture

• Before every measurement, relax for about five minutes. Otherwise deviations can occur.
•  You can take the measurement while sitting or lying down. To take your blood pressure, 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.

Performing the blood pressure measurement

As described above, attach the cuff and adopt the posture in which you want to perform the measurement.

• 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 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 measurements are displayed.

•  appears if the measurement has not been performed properly. Observe the chapter on error messages/troubleshooting in these instructions for use and repeat the measurement.

• 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 automatically after approx. 1 minute.
  In this case too, the value is stored in the selected or most recently used user memory.
  Wait at least 5 minutes before taking another measurement!

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 heartbeat. 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.

Classification of measurements:
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 different 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 values fall into. If the values of systole and diastole fall into two different categories (e.g. systole in the ‘High normal’ category and diastole in the ‘Normal’ category), the graphical 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- tension| 160 – 179| 100 – 109| seek medical attention
Setting 1:

mild hypertension

| 140 – 159| 90 – 99| regular monitoring by doctor
High normal| 130 – 139| 85 – 89| regular monitoring by doctor
Normal| 120 – 129| 80 – 84| self-monitoring
Optimal| < 120| < 80| self-monitoring

Source: WHO, 1999 (World Health Organization)

Display and delete 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.

• To retrieve the measurement, press the memory button M.

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.
   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.).

• Press the memory button M.
  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 measurement 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.

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 measured ( or appears on the display)
• the systolic or diastolic pressure was outside the measurement range (“ ” or “ ” appears on the display)
• the cuff is fastened too tightly or too loosely ( appears on the display)
• the blood pressure is higher than 297 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

Cleaning and storing the device and cuff

• 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.

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 “  ”. 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.

Technical specifications

the wrist
Measurement range| Cuff 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 inaccuracy| Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg
Memory| 2 x 60 memory spaces
Dimensions| L 83.8 mm x W 59.9 mm x H 29.4 mm
Weight| Approximately 92 g (without batteries)
Cuff 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, 700–1060 hPa ambient pressure
Power supply| 2 x 1.5V AAA batteries
Battery life| For approx. 170 measurements, depending on levels of blood pressure and pump pressure
Accessories| Instructions for use, 2 x 1.5V AAA batteries, storage box
Classification| Internal supply, IPX0, no AP or APG, continuous operation, application part type BF

Technical information is subject to change without notification to allow for updates.

• This device complies with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Services address or found at the end of the instructions for use.
• The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktegesetz) and the standards EN1060-1 (Non-invasive sphygmomanometers – Part 1: General requirements), EN1060-3 (Non-invasive sphygmomanometers – 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 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.

Electromagnetic Compatibility Information

For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’s declaration – electromagnetic emission

The SBC 15 is intended for use in the electromagnetic environment specified below.
The customer or the user of the SBC 15 should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 2| The SBC 15 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF emissions CISPR 11| Class B| The SBC 15 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not applicable

For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity

The SBC 15 is intended for use in the electromagnetic environment specified below. The customer or the user of the SBC 15 should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ± 6 kV contact

± 8 kV air

| ± 6 kV contact

± 8 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration – electromagnetic immunity

The SBC 15 is intended for use in the electromagnetic environment specified below. The customer or the user of the SBC 15 should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Radiated RF IEC 61000-4-3| 3 V/m
80 MHz to 2.5 GHz| 3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the SBC 15, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d = 1.2   80 MHz to 800 MHz
d = 2.3  800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SBC 15 is used exceeds the applicable RF compliance level above, the SBC 15 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SBC 15.
b  Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the SBC 15

The SBC 15 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SBC 15 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SBC 15 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter
(W)| Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz

d = 1.2

| 80 MHz to 800 MHz

d = 1.2

| 800 MHz to 2.5 GHz

d = 2.3

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Customer Support

Hans Dinslage GmbH, Riedlinger Str. 28, 88524 Uttenweiler, Germany
www.sanitas-online.de

  0483

References

• Sanitas - health & wellbeing
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