Sanitas SBM 21 User manual

D Gebrauchsanleitung
Blutdruckmessgerät................................................................(2–10)
G Instruction for Use
Blood pressure monitor....................................................(11–18)
F Mode d’emploi
Tensiomètre.....................................................................(19–27)
I Instruzioni per l’uso
Misuratore di pressione ..................................................... (28–35)
r Инструкция по применению
Прибор для измерения артериального
давления на предплечье................................................(36–44)
SBM 21
Serviceadresse:
Hans Dinslage GmbH
Riedlinger Straße 28
88524 Uttenweiler, GERMANY
Tel.-Nr.: +49 (0)7374/915766
Fax-Nr.: +49 (0)7374/920723
E-mail: [email protected]
0483

11
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 instrument
The upper arm blood pressure monitor is used for non-invasive
measurement and monitoring of adults’ arterial blood pressure.
You can use it to measure your blood pressure quickly and eas-
ily, storing the results and displaying the progression of read-
ings together with the average.
A warning is issued for anyone suffering from cardiac arrhythmia.
The values determined are classified and graphically evaluated
according to WHO guidelines.
Keep these instructions carefully for further use and also let
other users have access to them.
2. Important information
Advice on use
• Always measure your blood pressure at the sam time of day,
in order to ensure that values are comparable.
• Relax for approx. 5 minutes before each measurement.
• You should wait five minutes before measuring a second
time.
• The readings that you take may only be used for information
purposes – they are not a substitute for a medical examina-
tion! Discuss your results with the doctor. Never use them
to make medical decisions independently (e.g. regarding
medication and dosage thereof).
• There may be incorrect measurements where there is cardio-
circulatory disease, as well as with very low blood pressure,
circulatory disorders, dysrhythmia and other preexisting
diseases.
• Only use the instrument on persons whose upper arm has
the right circumference for the instrument.
• You can operate the blood pressure monitor with batteries.
Note that it is only possible to save data when your blood pres-
sure monitor is receiving power. As soon as the batteries are
dead, the date and time on the blood pressure monitor are lost.
• The automatic switch-off function switches off the blood
pressure monitor in order to preserve the batteries, if no but-
ton is pressed within 3 minutes.
Storage and Care
• The blood pressure monitor is made up of precision electron-
ic components. Accuracy of readings and the instrument’s
service life depend on careful handling.
– You should protect the device from impact, moisture, dirt,
major temperature fluctuations and direct exposure to the
sun’s rays.
– Never drop the device.
– Do not use near strong electromagnetic fields, i.e. keep it
away from any radio systems and mobile phones.
– Only ever use the cuffs provided with the monitor or origi-
nal replacement cuffs. Otherwise erroneous results will be
recorded.
ENGLISH

12
• Do not press any buttons until the cuff is in position.
• If the instrument is not used for any length of time, we
recommend removing the batteries.
Advice on batteries
• Batteries can be fatal if swallowed. You should therefore
store the batteries and products where they are inaccessible
to small children. If a battery has been swallowed, call a doc-
tor immediately.
• Batteries should not be charged or reactivated with any other
means, nor should they be taken apart, thrown in the fire or
short-circuited.
• Remove the batteries from the instrument if they are worn
out or if you are not going to use the instrument for any
length of time. This prevents any damage as a result of leak-
age. Always replace all the batteries at the same time.
• Never use different types of battery, battery brands or bat-
teries with different capacities. You should preferably use
alkaline batteries.
Repair and disposal
• Batteries do not belong in domestic refuse. Used batteries
should be disposed of at the collection points provided.
• Never open the instrument. If these instructions are not
heeded, the warranty will be null and void.
• Never attempt to repair the instrument or adjust it yourself.
We can no longer guarantee perfect functioning if you do.
• Repairs may only be performed by Customer Service or
authorized dealers. However, always check the batteries and
replace them if necessary prior to making any complaint.
• The appliance should be disposed of according to
Regulation 2002/96/EC-WEEE (Waste Electrical and
Electronic Equipment). In case of queries, please con-
tact the municipal authorities responsible for waste disposal
in your area.

13
3. Unit description
1. Cuff
2. Cuff line
3. Cuff connector
4. Display
5. START/STOP button
6. Memory button M+
7. SET button
8. Function buttons -/+
9. WHO scale
Icons in the display:
1. Systolic pressure
2. Unit in mmHg
3. Diastolic pressure
4. Pulse symbol and calculated pulse value
5. Time and date
6. Cardiac arrhythmia symbol
7. Average values of the 3 most recent measurements – AVG
8. Pump up, release air (arrow)
9. WHO classification
10. Battery replacement symbol
11. Symbol for users 1, 2, 3 and 4
SYS
mmHg
DIA
mmHg
PULSE
/
min
SET
M
+
+
–
4
123
6
7
8
9
5
WHO
5
1
6
7
8
9
10
11
3
4
2

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4. Prepare measurement
Inserting battery
• Remove the battery cover from the
back of the monitor.
• Insert four AA 1.5 V alkaline
batteries. Making absolutely
sure that you insert them with
the correct polarity as marked.
Never use rechargeable batteries.
• Replace the battery cover carefully.
If 4 warning tones have been sounded and the symbol
appears simultaneously on the display, it is no longer possible
to perform a measurement and all batteries must be replaced.
Once the batteries have been removed from the device, the
time must be set again. Used batteries should not be disposed
of in normal household waste. Dispose of them via your elec-
tronics retailer or your local recycling point.
You are legally obligated to do so.
Note: Batteries containing pollutant substances
are marked as follows: Pb = Battery contains lead,
Cd = Battery contains cadmium, Hg = Battery
contains mercury.
Setting date and time
You should set the date and time without fail. Otherwise, you
will not be able to save your measured values correctly with
a date and time and to access them again later. The time is
shown in 12-hour format i.e. the time from 13:00 is displayed
as 01:00 PM.
Proceed as follows to set the date and time:
• Confirm twice using the SET button.
• Use the + or - buttons to first set the month 1–12, and then
confirm using the SET button.
• Set the day/hour/minute and confirm each using the SET
button.
Press the button to exit the settings mode.
5. Measuring blood
pressure
Positioning cuff
Fit the cuff round your bare left up-
per arm. Blood circulation in the
arm should not be restricted by tight
clothing or other objects.
The cuff should be placed on the
upper arm so that the lower edge is 2
to 3 cm above the bend of the elbow
and above the artery. The tube should
be in line with the centre of the palm.
Now place the free end of the cuff
snugly, but not too tightly, around
the arm, and fix it with the Velcro fas-
4 x AA
(
LR06
)
1,5
V

15
tener. The cuff should be fitted tight
enough to allow just two fingers to fit
beneath the cuff.
Insert the cuff tubing into the socket
for the cuff attachment.
Important: The instrument should only be operated with the
original cuff. The cuff is suitable for an arm circumference of
22 to 36 cm.
Correct posture
• Rest for approx. 5 minutes before each measurement. Other-
wise there may be divergences.
• You can perform the measurement either sitting or lying down.
Always make sure that the cuff is on a level with your heart.
• In order not to distort the result, it is important to keep still
during the measurement and not talk.
Select memory
Press the SET button. Select the desired storage space by
pressing the -/+ function buttons. You have 4 memories with 30
spaces each to store the measurements of 4 different people
separately or to separate measurements taken in the morning
and at night.
Confirm your selection with the button .
Measuring blood pressure
• Put on the cuff as described previously and assume the
position in which you want to carry out the measurement.
• Start the measurement by holding the button . After check-
ing the display, during which all numbers light up, the cuff
pumps up automatically. Whilst the cuff is pumping up, the
device already calculates measurements for estimating the
necessary pump pressure.
If this pressure is insufficient, the device automatically
pumps more pressure.
• Then the pressure in the cuff is slowly released and the pulse
is measured.
• When the measurement has been completed, the remaining
air pressure is released very quickly. The pulse, the systolic
and the diastolic blood pressure are displayed.
• Measuring can be cancelled at any time by pressing the but-
ton .
• If a higher pump pressure is always required, you can bypass
the additional pumping process by holding the M+ button
shortly after the pumping process starts until the desired cuff
pressure is reached. This should be approx. 30 mmHg above
the systolic value.
• The Err icon appears if it has not been possible to perform
the measurement properly. Observe the section in these in-
structions on error messages/troubleshooting and repeat the
measurement.
• The device switches off automatically after 3 minutes.
Wait at least 5 minutes before taking another measurement!

16
The bar graph in the display and the scale on the unit indicate
the range of the blood pressure which has been recorded.
If the values for systolic and diastolic pressure are in two dif-
ferent WHO ranges (e.g. systolic in the high-normal range and
diastolic pressure in the normal range) the graphic WHO clas-
sification on the unit indicates the higher range (high-normal in
the example described).
6. Saving, retrieving and deleting results
• The results of each successful measurement are stored
together with date and time. With more than 30 items of
measured data, the earliest items of data measured are lost.
• Use the SET button and then the -/+ buttons to select the
desired user memory and confirm using the button . Press-
Evaluating results
Cardiac arrhythmia:
This instrument can identify possible cardiac arrhythmia
disorders during measurement and if necessary indicates the
measurement with the flashing icon .
This may be an indicator for arrhythmia. Arrhythmia is a condi-
tion where the heart rhythm is abnormal as a result of defects
in the bioelectrical system controlling the heart beat. The
symptoms (omitted or premature heart beats, slow or exces-
sively fast heart rate) may be caused, among other things, by
heart disease, age, physical predisposition, excessive use of
stimulants, stress or lack of sleep. Arrhythmia can only be as-
certained through examination by your doctor.
Repeat the measurement if the flashing icon is displayed
after the measurement. Please note that you should rest for
5 minutes between measurements and not talk or move dur-
ing the measurement. If the icon appears often, please
contact your doctor. Any self-diagnosis and treatment based
on the test results may be dangerous. It is vital to follow your
doctor’s instructions.
WHO classification:
According to WHO Guidelines/Definitions and the latest find-
ings, the test results can be classified and evaluated according
to the following chart:
Range of blood pressure values Systolic (in mmHg) Diastolic (in mmHg) Measure
Grade 3: Severe hypertension >=180 >=110 Seek medical advice
Grade 2: Moderate hypertension 160–179 100–109 Seek medical advice
Grade 1: Mild hypertension 140–159 90–99 Have it checked regularly by doctor
High-normal 130–139 85–89 Have it checked regularly by doctor
Normal 120–129 80–84 Check it yourself
Optimal <120 <80 Check it yourself
Source: WHO, 1999

17
ing the M+ button displays the average value AVG of the 3
most recent measurements stored in the user memory. By
pressing the + button, the most recent measurements are
displayed; by pressing the - button, the oldest are displayed.
• The average value AVG can only be displayed if there are 3
saved values in the respective user memory.
• To clear the memory, you must first select a user memory.
Hold the SET button pressed for approx. 3 seconds. All the
values in the current user memory are deleted after 3 brief
beeps are output.
• If you wish to change the user memory, see “Select memory”.
7. Cleaning and storing the instrument
• Clean your device and cuff carefully only with a slightly mois-
tened cloth.
• Do not use detergents or solvents.
• On no account must you immerse the computer in water,
otherwise liquid can enter it and cause demage.
• When storing the device, make sure that no heavy objects
are placed on top of it. Remove the batteries. The cuff tube
should not have any sharp kinks.
8. Error messages/troubleshooting
In case of faults, the Err message appears in the display.
Error messages can occur when
1. inflation pressure is higher than 300 mmHg,
2. blood pressure is unusually high or low,
3. you move or talk during the measurement.
In the above cases, you must repeat the measurement. Make
sure that the cuff tube is properly inserted and that you do
not move or talk. Re-insert the batteries if necessary, or else
replace them.
9. Specifications
Model No. SBM 21
Method of Measure-
ment
Oscillometric, non-invasive blood pres-
sure measurement on the upper arm
Range of Measurement systolic 0 – 300 mmHg,
diastolic 0
– 300 mmHg,
pulse 30
– 180 beats/minute
Accuracy of the
pressure reading
systolic ±3 mmHg/diastolic ±3 mmHg/
pulse ±5% of the displayed value
Measuring uncertainty max. permissible standard deviation
according to clinical testing:
systolic: 8 mmHg/diastolic: 8 mmHg
Sets of Memory 4 x 30 memory places
Unit Dimension L155 x W110 x H70 mm
Unit Weight Approx. 405 g
Cuff Size Cuff for upper arm circumference of
22 to 36 cm
Operating Temperature +5°C to +40°C, < 85% RH
Storage- and
transporttemperature
-10°C to +55°C, < 95% RH
Power Supply 4 x 1,5 V AA batteries (alkaline type
LR06)

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Battery Life For approx. 250 measurements,
depending on blood pressure level or
inflation pressure
Accessories
With storage pouch, instruction manual,
4 pcs AA battery LR 06
Classification Application part Type B
Protection class internal power supply, IPXO, no AP or
APG, continuous operation
Key to symbols Application part Type B
Important! Read the operating
instruction!
These specification are subject to change without notice for
purpose of improvement.
• This unit is in line with European Standard EN60601-1-2 and
is subject to particular precautions with regard to electro-
magnetic compatibility (EMC). Please note that portable and
mobile HF communication systems may interfere with this in-
strument. For more details, please contact customer service
at the address indicated.
• The instrument is in line with the EU Medical Products
Directive 93/42/EC, the German medical products act and
European standards EN1060-1 (non-invasive blood pres-
sure monitors, Part 1: general requirements) and EN1060-3
(non-invasive blood pressure monitors, Part 3: Supplemen-
tary Requirements for Electromechanical Blood Pressure
Measurement Systems).
• If you are using the instrument for commercial or economic
purposes, you must check measurement precision regularly
in accordance with the “Operators’ Ordinance on Medical
Products”. Even in the case of private use, we recommend
checking measurement precision every two years at the
manufacturers.