Sanitas SBC 22 Blood Pressure Monitor Instruction Manual

: June 10, 2024
: Sanitas

Table of Contents

INCLUDED IN DELIVERY
SIGNS AND SYMBOLS
INTENDED USE
WARNINGS AND SAFETY NOTES
DEVICE DESCRIPTION
INITIAL USE
USAGE
CLEANING AND MAINTENANCE
REMEDY
DISPOSAL
TECHNICAL SPECIFICATIONS
WARRANTY/SERVICE
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

SBC 22

Unfold page 3 before reading the instructions for use.

Sanitas SBC 22 Blood Pressure Monitor - fig1

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

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 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 Service address.

1x Blood pressure monitor with cuff
2x 1.5 V LR03 AAA batteries
1x Storage box
1x Instructions for use

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 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
| Do not dispose of batteries containing hazardous substances with household waste
| 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
| Temperature 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
| 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.

INTENDED USE

Purpose
The blood pressure monitor is intended for the fully automatic, 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 environment and is suitable for users whose wrist circumference is within the range printed on the cuff.
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 previous measurements.

WARNINGS AND SAFETY NOTES

Contraindications

Do not use the blood pressure monitor on newborns, children or pets.
People with restricted physical, sensory or mental skills should be supervised by a person responsible for their safety 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: irregular 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 connection with a high-frequency surgical unit.
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.
Make sure that the cuff 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 environment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physical activity such as playing sport) can influence the measurement accuracy and cause incorrect measurements.
Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy.
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 cuffs included in delivery or cuffs described in these instructions for use for the device. Using another cuff may lead to measurement inaccuracies.
Note that when inflating the cuff, the functions of the limb in question may be impaired.
Do not perform measurements more frequently than necessary. Due to the restriction of blood flow, some bruising may occur.
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 wrist.
Place the cuff on your wrist only. Do not place the cuff on other parts of the body.
Small parts may present a choking hazard for small children if swallowed. They should therefore always be supervised.

General precautions

The blood pressure monitor is made from precision and electronic components. The accuracy of the measurements 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 measuring. If the measuring device has been stored close to the maximum or minimum storage and transport temperatures 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 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.

Measures for 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. 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.
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 environments.
The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
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 performance of the device.

DEVICE DESCRIPTION

The corresponding drawings are shown on page 3.

Display
Wrist cuff
Risk indicator
Start/stop button
Memory button
Battery compartment lid

Information on the display:
The corresponding drawings are shown on page 3.

Systolic pressure
Diastolic pressure
Calculated pulse rate
Cardiac arrhythmia symbol
Pulse symbol
Release air
User memory
Risk indicator
Memory space number
memory display for
average value ( ),
morning ( ),
evening ( )
Battery replacement symbol
Time and date

INITIAL USE

Inserting the batteries

Remove the battery compartment lid on the left side of the device A .
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 A . 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 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 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 succes-sion:

Sanitas SBC 22 Blood Pressure Monitor - icon28

Hour format
The hour format flashes on the display.

Select the desired hour format using the memory 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 display 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 off automatically.

USAGE

Attaching the cuff

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-measurement, consult your doctor in this regard. From this point on, always take measurements on the same wrist.
The device may only be operated with the cuff attached when supplied. Before using the device, the user should check the fit of the cuff and, in doing so, ensure that their wrist circumference is within the range printed on the cuff.
Uncover your wrist. Ensure that the circulation of the wrist is not hindered by tight clothing or similar.
Now place the cuff on the wrist so that the palm of your hand and the device display are facing upwards B 1 .
Position the cuff 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 cuff 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 C .
Place your feet flat on the ground next to one another.
The cuff 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 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.

Systolic pressure, diastolic pressure and pulse 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 . 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 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 differences between the measured values may occur. One-off or irregular measurements therefore do not provide reliable information about the actual blood pressure. Reliable assessment is only possible when you perform the measurement regularly under comparable conditions.

Risk indicator
The World Health Organization (WHO) has defined the internationally recognised classification for the evaluation of measured blood pressure values listed in the table below:

Blood 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 associated scale on the device) shows which category the recorded blood pressure values fall into. If the measured values are in two different classifications (e.g. systole in the high normal category and diastole in the normal category), the risk indicator then always shows you the higher category – “high normal” 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 different people and different age groups, etc. Furthermore, it must be noted that measurements taken yourself 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 measurement, 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 measurement, the measurement must be repeated as the measurement accuracy may be impaired. To assess your blood pressure, 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.

Saving, accessing 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.

To retrieve the measurement, press the memory button

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 .
flashes on the display.
The average value of the morning measurements for the last 7 days is displayed (morning: 5 a.m. – 9 a.m.).
Press the memory button .
flashes on the display.
The average value of the evening measurements 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 off 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.
Press and hold the memory button and the START/ STOP button for 5 seconds, depending on the user memory you are in.

CLEANING AND MAINTENANCE

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.

REMEDY

Error message	Possible cause	Solution
The systolic or diastolic pressure 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 pressure is outside of the measurement 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 cuff was not attached correctly.| Please observe the infor-mation in the chapter on “Attaching the cuff”.
| The blood pressure is higher than 300 mmHg for more than
1.5 seconds.| 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 180 seconds.| Please take another measurement to check whether the cuff can be correctly inflated.
Please observe the information in the chapter on “Attaching the cuff”.
| There is a system or device error.| Please contact customer service.
| The batteries are almost empty.| Insert new batteries into the device.

DISPOSAL

Repairing and disposing of the device

Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.
Do not open the device. Failure to comply with this instruction 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 responsible for waste disposal.

Disposing 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.

TECHNICAL SPECIFICATIONS

Type	SBC 22
Model	SBC 15
Measurement method	Oscillometric, non-invasive blood pressure measurement on

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 uncertainty| 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 cuff)
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, 800 –1050 hPa ambient pressure
Power supply| 2 x 1.5-V AAA batteries
Battery life| For approx. 170 measurements, depending on levels of blood pressure and inflation pressure
Classification| Internal supply, IP22, no AP or APG, continuous operation, application part type BF

The 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 standard 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 toelectromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.
The device complies with the EU Medical Devices Directive 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- nvasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC 80601-2-30 (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 the device is used 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.