Medel Check User manual

Professional Blood Pressure Monitor
Instruction manual
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1. INTRODUCTION
1.1. MEDEL CHECK Features
MEDEL CHECK is a fully automatic, digital blood pressure measuring device with
integrated Average mode - CHECK3 technology for use on the upper arm. MEDEL
CHECK enables very fast and reliable measurement of the systolic and diastolic
blood pressure as well your pulse by use of the oscillometric method.
Average mode - CHECK3 technology is a new type of concept for optimum relia-
bility in self-measurement of blood pressure.
MEDEL CHECK is easy to use and is proven in clinical studies to provide excellent
accuracy. This device is validated by a protocol (Protocol for the evaluation of
blood pressure measuring) created by the British Hypertension Society. MEDEL
CHECK has obtained, thanks to its accuracy, the highest evaluation level:
Systolic pressure - A Degree
Diastolic pressure - A Degree
Before using MEDEL CHECK, please read through this instruction manual
carefully and then keep it in a safe place. For further questions on the subject of
blood pressure and its measurement, please contact your doctor.
Attention!
1.2. Important information about check-measurement
• Do not forget: self-measurement means control, not diagnosis or treatment.
Unusual values must always be discussed with your doctor.
Under no circumstances should you alter the dosages of any drugs pre-
scribed by your doctor.
• The pulse display is not suitable for checking the frequency of heart pace-
makers!
• In cases of cardiac irregularity (Arrhythmia), measurements made with this
instrument should only be evaluated after consultation with the doctor.
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Table of contents
1. INTRODUCTION 27
1.1. MEDEL CHECK features 27
1.2. Important information about self-measurement 27
2. IMPORTANT INFORMATION ON THE SUBJECT OF BLOOD-PRESSURE 28
AND ITS MEASUREMENT
2.1. How does high/low blood-pressure arise? 28
2.2. Which values are normal? 28
2.3. What can be done, if regular high/low values are obtained? 29
2.4. Average mode - CHECK3 technology 31
3. THE VARIOUS COMPONENTS OF THE BLOOD-PRESSURE MONITOR 33
4. PUTTING THE BLOOD-PRESSURE MONITOR INTO OPERATION 34
4.1. Inserting the batteries 34
4.2. Using a mains adapter 35
4.3. Tube connection 35
5. CARRYING OUT A MEASUREMENT 36
5.1. Before the measurement 36
5.2. Common sources of error 36
5.3. Fitting the cuff 37
5.4. Measurements mode selection 38
5.5. Measuring procedure 39
5.6. Discontinuing a measurement 40
5.7. Memory – displaying the last measurements 40
6. ERROR MESSAGES/MALFUNCTIONS 41
7. MAINTENANCE AND REPAIRS 43
8. CARE AND MAINTENANCE, RECALIBRATION 44
9. REFERENCE TO STANDARDS 45
10. TECHNICAL SPECIFICATIONS 46
11. WARRANTY 47
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and/or diastolic values under 60mmHg, likewise, please consult your doctor.
Even with normal blood-pressure values, a regular self-check with your blood-pres-
sure monitor is recommended. In this way you can detect possible changes in your
values early and react appropriately.
If you are undergoing medical treatment to control your blood pressure, please
keep a record of the level of your blood pressure by carrying out regular self-mea-
surements at specific times of the day. Show these values to your doctor. Never use
the results of your measurements to alter independently the drug doses prescri-
bed by your doctor.
Table for classifying blood-pressure values (units mmHg):
Range Systolic Blood-pressure Diastolic Blood-pressure Measures
(maximum) (minimum)
Hypotension lower than 100 lower than 60 Check with your
doctor
Normal range between 100 and 140 between 60 and 90 Self-check
Mild hypertension between 140 and 160 between 90 and 100 Consult your doctor
Moderately serious between 160 and 180 between 100 and 110 Consult your doctor
hypertension
Serious hypertension higher than 140 higher than 110 Urgent!
See your doctor
Specific systolic higher than 140 lower than 90 Consult your doctor
hypertension
Further information
• If your values are mostly standard under resting conditions but exceptionally
high under conditions of physical or psychological stress, it is possible that
you are suffering from so-called ”labile hypertension”. Please consult your
doctor if you suspect that this might be the case.
• Correctly measured diastolic blood-pressure values above 120mmHg requi-
re immediate medical treatment.
Electromagnetic interference:
The device contains sensitive electronic components (Microcomputer). Therefore,
avoid strong electrical or electromagnetic fields in the direct vicinity of the device
(e.g. mobile telephones, microwave ovens). These can lead to temporary impair-
ment of the measuring accuracy.
2. IMPORTANT INFORMATION ON THE SUBJECT OF
BLOOD-PRESSURE AND ITS MEASUREMENT
2.1. How does high/low blood-pressure arise?
The level of blood-pressure is determined in a part of the brain, the so-called cir-
culatory centre, and adapted to the respective situation by way of feedback via the
nervous system.
To adjust the blood-pressure, the strength and frequency of the heart (Pulse), as well
as the width of circulatory blood vessels is altered. The latter is effected by way of
fine muscles in the blood-vessel walls.
The level of arterial blood-pressure changes periodically during the heart activity:
during the ‘blood ejection‘ (Systole) the value is maximal (systolic blood-pressure
value), at the end of the heart’s ‘rest period’ (Diastole) it is minimal (diastolic blood-
pressure value).
The blood-pressure values must lie within certain normal ranges in order to prevent
particular diseases.
2.2 Which values are normal?
Blood pressure is too high if at rest the systolic blood-pressure is over 160mmHg
and/or the diastolic blood-pressure is above 90mmHg. In this case, please consult
your doctor immediately. Long-term values at this level endanger your health due
to the associated advancing damage to the blood vessels in your body.
Should the systolic blood-pressure values lie between 140mmHg and 160mmHg
and/or the diastolic blood-pressure values lie between 90mmHg and 100mmHg, like-
wise, please consult your doctor. Furthermore, regular self-checks will be necessary.
With blood-pressure values that are too low, i.e. systolic values under 105mmHg
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D) Physical constitution:
• After a preliminary medical examination, do regular sport.
• Choose sports which require stamina and avoid those which require strength.
• Avoid reaching the limit of your performance.
• With previous illnesses and/or an age of over 40 years, please consult your
doctor before beginning your sporting activities. He will advise you regar-
ding the type and extent of types of sport that are possible for you.
2.4. CHECK3 technology
• CHECK3 technology is a new type of concept for optimum reliability in self-
measurement of blood pressure.
• An advanced measurement accuracy is achieved by the automatic analysis
of three successive measurements.
• The new system provides reliable values for the doctor and can be used as
the basis for reliable diagnostics and medication therapy for high blood
pressure.
A) Why CHECK3 technology?
• Human blood pressure is not stable
• Scattering of devices
B) Key advantages
Reduction of:
• Device scattering
• Insufficient rest prior to measurement
• Movement artefacts
• Cuff positioning influences
C) Medical benefits
• Improved accuracy
• Reliable patient self-measurement data for the doctor
• Safe hypertension diagnostic
• Reliable therapy control
D) Measurement sequence
• First measurement
2.3. What can be done, if regular increased/low values are obtained?
a) Please consult your doctor.
b) Increased blood-pressure values (various forms of hypertension) are asso-
ciated long- and medium term with considerable risks to health. This con-
cerns the arterial blood vessels of your body, which are endangered due to
constriction caused by deposits in the vessel walls (Arteriosclerosis). A defi-
cient supply of blood to important organs (heart, brain, muscles) can be the
result. Furthermore, with long-term continuously increased blood-pressure
values, the heart will become structurally damaged.
c) There are many different causes of the appearance of high blood pressure.
We differentiate between the common primary (essential) hypertension, and
secondary hypertension. The latter group can be ascribed to specific orga-
nic malfunctions. Please consult your doctor for information about the possi-
ble origins of your own increased blood pressure values.
d) There are measures which you can take, not only for reducing a medically
established high blood pressure, but also for prevention. These measures are
part of your general way of life:
A) Eating habits
• Strive for a normal weight corresponding to your age. Reduce overweight!
• Avoid excessive consumption of common salt.
• Avoid fatty foods.
B) Previous illnesses
• Follow consistently any medical instructions for treating previous illness
such as:
- Diabetes (Diabetes mellitus)
- Fat metabolism disorder
- Gout
C) Habits
• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (Coffee).
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3. THE VARIOUS COMPONENTS OF THE
BLOOD-PRESSURE MONITOR
The illustration shows the blood-pressure monitor MEDEL CHECK, consisting of:
a) Measuring unit
b) Cuff:
Standard: for arm circumference 22-32 cm
X-Large: for arm circumference 32-42 cm
(available as optional accessory)
LCD
Flip
O/I and MEMORY 3”
Button
Cuff Jack
Socket
AC/DC Jack
1/3 mode
Single mode/
Average mode - CHECK3
• 15 seconds resting time
• Second measurement
• 15 seconds resting time
• Third measurement
• Data analysis
• Systolic, diastolic blood-pressure and pulse rate appear in the display.
E) Data analysis
CHECK3 technology is based on processing 3 valid subsequent measurements, i.e.
3 measurements that can be comparable. Possible wrong measurements will be
deleted and reprocessed again. MEDEL CHECK automatically processes 3 mea-
surements of blood pressure and heart rate. After each measurement the device
stops for 15 seconds to allow physiologic restoration of blood flow. During this
break the countdown shows on the display advising start of a new measurement
with 5 sec. notice. When 3 measurements have been completed, MEDEL CHECK
processes the data and the values of systolic and diastolic pressure are shown
along with heart rate. Measurement with CHECK3 technology takes less than 3
minutes.
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4.2. Using a mains adapter
(optional accessory)
It is possible to operate this blood-pressure device
through a mains adapter (output 6 V DC / 600
mA with DIN plug). Use only original MEDEL
mains adapter.
a) Plug the DIN plug into the socket at the back
of the device.
b) Plug the mains adapter into a 230 V power
socket.
c) Test that power is available by opening the
flip.
Attention!
• No power is taken from the batteries while
the mains adapter is connected to the instru-
ment.
• If the mains voltage is interrupted during the
measurement (e.g. by removal of the mains
adapter from the mains socket), the device
must be reset by removing the DIN plug
from its socket.
• Please consult a specialist dealer if you have
questions relating to the mains adapter.
4.3. Tube connection
Insert the cuff tube into the opening provided on
the left side of the device, as shown in the picture.
4. PUTTING THE
BLOOD-PRESSURE MONITOR
INTO OPERATION
4.1. Inserting the batteries
After you have unpacked your device, first insert
the batteries. The battery compartment is located
on the underside of the device (see illustration).
a) Remove cover as illustrated.
b) Insert the batteries (4 x size AA 1,5V), the-
reby observing the indicated polarity.
c) Open the flip and press O/I button to turn
on the device.
d) If the battery warning appears in the dis-
play, the batteries are empty and must be
replaced by new ones.
Functional check: press O/I button to test all the
display elements. When functioning correctly, all
segments must appear.
Attention!
• After the battery warning appears, the devi-
ce is blocked until the batteries have been
replaced.
• Please use “AA” Long-Life or Alkaline 1.5V
Batteries.
The use of rechargeable batteries is not
recommended.
If the blood-pressure monitor is left unused for
long periods, please remove the batteries from the
device.
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5. CARRYING OUT A MEASUREMENT
5.1. Before the measurement:
• Avoid eating, smoking as well as all forms of exertion directly before the
measurement. All these factors influence the measurement result. Try and find
time to relax by sitting in an armchair in a quite atmosphere for about ten
minutes before the measurement.
• Remove any garment that fits closely to your upper arm.
• Measure always on the same arm (normally left).
• Attempt to carry out the measurements regularly at the same time of day,
since the blood-pressure changes during the course of the day.
5.2. Common sources of error:
Note:Comparable blood-pressure measurements always require the same con-
ditions!
These are normally quiet conditions.
• All efforts by the patient to support the arm can increase the blood-pressure.
Make sure you are in a comfortable, relaxed position and do not activate
any of the muscles in the measurement arm during the measurement. Use a
cushion for support if necessary.
• If the arm artery lies considerably lower (higher) than the heart, an erro-
neously higher (lower) blood-pressure will be measured (Each 15cm diffe-
rence in height results in a measurement error of 10mmHg!).
• Cuffs that are too narrow or too short result in false measurement values.
Selecting the correct cuff is of extraordinary importance. The cuff size is
dependent upon the circumference of the arm (measured in the centre). The
permissible range is printed on the cuff. If this is not suitable for your use,
please contact your dealer.
Attention: Only use clinically approved MEDEL original cuffs!
• A loose cuff or a sideways protruding air-pocket causes false measurement
values.
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5.3. Fitting the cuff
a) Pass the end of the cuff (with sewn-in rubber
stopper) through the metal stirrup so that a loop
is formed. The Velcro closer must be facing out-
wards. (Ignore this step if the cuff has already
been prepared.)
b) Push the cuff over the left upper arm so that the
tube points in the direction of the lower arm.
c) Position the cuff on the arm as illustrated. Make
certain that the lower edge of the cuff lies
approximately 2 to 3 cm above the elbow and
that the rubber tube leaves the cuff on the inner
side of the arm. Important! The mark (ca. 3 cm
long bar) must lie exactly over the artery which
runs down the inner side of the arm.
d) Tighten the free end of the cuff and close the cuff
with the closer.
e) There must be no free space between the arm
and the cuff as this would influence the result.
Clothing must not restrict the arm. Any piece of
clothing which does (e.g. a pullover) must be
taken off.
f) Secure the cuff with the Velcro closer in such a
way that it lies comfortably and is not too tight.
Lay the arm on the table (palm upwards) so that
the cuff is at the same height as the heart. Make
sure that the tube is not kinked.
g) Remain seated quietly for two minutes before
you begin the measurement.
2-3 cm
cuff edge tube
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a) Open the flip and press the O/I button. The
device begins to inflate the cuff. The rising pres-
sure in the cuff is shown in the display.
b) After the suitable inflation pressure has been
reached, the device stops and the pressure gra-
dually falls. The cuff pressures are displayed.
c) When the device detects a pulse, the heart
symbol in the display starts to flash and a beep
is heard for every heart beat.
d) A longer beep is sounded when the measure-
ment has been completed. The systolic, diastolic
blood pressures and pulse rate now appear in
the display.
e) When the unit is set to Average Mode - CHECK3
setting generally 3 separate measurements will
take place in succession and calculates your
detected blood pressure value. There will be 15
seconds resting time in-between each measure-
ment. A count down indicates the remaining
time and a beep will sound 5 seconds before the
2nd and 3rd readings will begin.
In case that the single data of each cycle differ
too much from each other, a fourth measure-
ment is performed before the result will be dis-
played. In rare cases the blood pressure is such
unstable that even after four measurements the
data vary too much. In this case “ERR 6“ is
shown and no result can be given.
f) The results of the measurement remain on the
display until you switch off the device. If no but-
Comment:
If it is not possible to fit the cuff to the left arm,
it can also be placed on the right one. However
all measurements should be made using the
same arm.
5.4. Measurement mode selection
Clinical studies demonstrate taking multiple blood
pressure readings and calculating an “average” is
more likely to determine your true blood pressure.
MEDEL CHECK allows you to switch the unit to a spe-
cial Average Mode - CHECK3 setting that automati-
cally takes multiple readings!
Average Mode - CHECK 3:
a) If you would like to take an Average Mode -
CHECK3 measurement, please press the button
for 3 seconds till “ON” appears on display.
b) Average Mode - CHECK3 takes generally 3
measurements in succession and calculates the
result.
c) An “3“ symbol in the display indicates that the
unit is set to the Average Mode - CHECK3.
Single mode:
a) If you would like to take single measurement,
press the button for 3 seconds till “OFF” appears
on display.
b) Single mode only has 1 measurement.
5.5. Measuring procedure
After the cuff has been appropriately positio-
ned, the measurement can begin:
ON
3
OFF
3
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6. ERROR MESSAGES/MALFUNCTIONS
If an error occurs during a measurement, the measurement is dis-
continued and a corresponding error code is displayed (example:
error no. 1):
Error n° Possible cause(s)
Err 1
Err 2
Err 3
Err 5
Err 6
The systolic pressure was determined but afterwards the cuff pressure fell below 20
mmHg. This situation can occur, for example, if the tube becomes unplugged after
the systolic blood pressure has been measured. Further possible cause: No pulse
has been detected.
Unnatural pressure impulses impair the result of the measurement.
Cause: the arm was moved during the measurement (artefact).
Inflation of the cuff takes too long.
Cause: 1) The cuff is not correctly seated or the hose connection is not sealed.
2) The cuff could be damaged, change it.
The measured readings indicated an unacceptable difference between systolic and
diastolic pressures. Take another reading following directions carefully. Contact
you doctor if you continue to get unusual readings.
Due to unstable conditions during measurements, it is not possible to calculate an
average result.
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ton is pressed for a period of 3 minutes the devi-
ce switches itself off in order to preserve the bat-
teries.
5.6. Discontinuing a measurement
If it is necessary to interrupt a blood pressure mea-
surement for any reason (e.g. the patient feels unwell),
the O/I button can simply be pressed at any time. You
can also close the flip to turn off the device. The devi-
ce immediately reduces the cuff pressure.
5.7. Memory – displaying the last measurement
The measured results are stored in the device until a
new measurement is carried out or the batteries are
removed. You can call up the stored values at any time
when the flip is open by pressing the O/I button for at
least 3 sec.
Further information
Wait for several minutes in a relaxed position, sitting or lying, before you repeat a
measurement.
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Should the device not start working properly, address immediately to an autho-
rized technical service centre or to MEDEL CUSTOMER SERVICE.
Further information
The level of blood-pressure is subject to fluctuations even with healthy people.
Important thereby is, that comparable measurements always require the same
conditions (Quiet conditions)!
If, in spite of observing all these factors, the fluctuations are larger than 15mmHg,
and/or you hear irregular pulse tones on several occasions, please consult your
doctor.
Other possible malfunctions and their elimination
If problems occur when using the device, the following points should be checked
and if necessary, the corresponding measures are to be taken:
The instrument frequently fails to
measure the blood pressure
values, or the values measured
are too low (too high).
Every measurement produces a
different value although the
instrument functions normally and
the values displayed are normal.
The blood pressure values mea-
sured differ from those measured
by the doctor.
1) Fit the cuff correctly on the arm.
2) Before starting the measurement make sure that the
cuff is not fitted too tightly and that there is no rolled-
up sleeve exerting pressure on the arm above the
measuring position. Take off articles of clothing if
necessary.
3) Measure the blood pressure again in complete peace
and quiet.
1) Please read the following information and the points
listed under ”Common sources of error”. Repeat the
measurement.
Please note: Blood pressure fluctuates continually
so successive measurements will show some variability.
1) Record the daily development of the values and con-
sult your doctor about them.
Please note: Individuals visiting their doctor fre-
quently experience anxiety which can result in a
higher reading at the doctor than obtained at home
under resting conditions.
Malfunction Remedy
The display remains empty when
the instrument is switched on
although the batteries are in
place.
1) Check whether the batteries are installed with the cor-
rect polarity and correct if necessary.
2) If the display is unusual, remove the batteries and then
them, or exchange them for new.
The pressure does not rise although
the pumping ball is pressed.
1) Check the connection of the cuff tube and connect
properly if necessary.
2) The cuff could be damaged, change it.
7. MAINTENANCE AND REPAIRS
In case of failure, address to qualified personnel authorized by Medel S.p.A..
Never open the device. There are no user-serviceable parts within. The device
requires no lubrication or maintenance.
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9. REFERENCE TO STANDARDS
Device standard: Device corresponds to the requirements of the
European standard for non-invasive
blood-pressure monitor
EN1060-1 / 12:95
EN1060-3 / 09:97
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP - requirements
Electromagnetic compatibility: Device fulfils the stipulations of the European
standard EN 60601-1-2
Clinical testing: The clinical performance test was carried out in
Germany according to the DIN 58130 / 1997
procedure N6 (sequential).
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa
have been fulfilled.
This device is validated by a protocol (Protocol for the evalua-
tion of blood pressure measuring) created by the British
Hypertension Society.
MEDEL CHECK has obtained, thanks to its accuracy, the
highest evaluation level:
Systolic pressure - A Degree
Diastolic pressure - A Degree
8. CARE AND MAINTENANCE, RECALIBRATION
a) Do not expose the device to either extreme temperatures,
humidity, dust or direct sunlight.
b) The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid
all types of straining through twisting or buckling.
c) Handle the tube carefully. Do not pull on it. Likewise, this is not to
be buckled or laid over sharp edges.
d) Clean the device with a soft, dry cloth. Do not use
petrol, thinners or similar solvent. Spots on the
cuff can be removed carefully with a damp cloth
and soapsuds. The cuff must not be washed!
e) Do not drop the instrument or threat it roughly
in any way. Avoid strong vibrations.
f) Never open the device! Otherwise the
manufacturer calibration becomes invalid!
Periodical recalibration
Sensitive measuring devices must from time to time be checked for accuracy. We
therefore recommend a periodical inspection of the static pressure display every 2
years.
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11. WARRANTY CERTIFICATE
Warranty conditions
- The device is covered by a 5 years warranty from date of purchase for any
defects in the design or in the materials used.
- The warranty consists in the replacement and/or repair free of charge of ori-
ginally defective components.
- The warranty does not cover the accessories supplied with the device and
those parts subject to normal wear and tear.
- The device must be repaired by authorized technical service centres only.
- The device must be sent to the authorized service centre for repair within 8
days after the defect is noticed.
- Transport costs for the device are at user’s charge.
- Any repair out of warranty conditions are at user’s charge.
- The warranty does not cover failures resulting from misuse, abuse of the pro-
duct or in case the damage is not due to manufacturer’s liability (accidental
fall, rough transportation, etc.).
- The warranty does not involve any compensation for any kind of damages to
persons or things, either direct or indirect, occurred when the device is not
operating.
- The warranty is valid from the date of purchase certified by the ticket or the
invoice which have to be peremptorily attached to the warranty coupon.
- The lack of warranty coupon properly filled in and validated by a certifica-
tion of purchase voids the warranty.
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10. TECHNICAL SPECIFICATIONS
Weight: 430 g (with batteries)
Size: 113(W) x 169(D) x 56(H) mm
Storage temperature: -5 to +50°C
Humidity: 15 to 85% relative humidity maximum
Operation temperature: 10 to 40°C
Display: LCD (Liquid Crystal Display)
Measuring method: oscillometric
Pressure sensor: capacitive
Measuring range: SYS/DIA: 30 to 280 mmHg
Pulse: 40 to 200 per minute
Memory: Storing the last measurements automatically
Measuring resolution: 1 mmHg
Accuracy: Pressure within ± 3 mmHg
Pulse ± 5 % of the reading
Power source: 4 dry cells (batteries) UM-3,
size AA, 1.5 V
Accessories: cuff for arm circumference 22-32 cm
Optional accessories: a) mains adapter output 6 V DC 600mA
(optional)
b) cuff for arm circumference 32-42 cm
Technical modifications reserved!
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COUPON TO BE RETURNED IN CASE OF REPAIRS
THE WARRANTY IS VALID ONLY IF
ACCOMPANIED BY THE TICKET/INVOICE
Product type:
Model:
Serial No.:
Date of purchase:
BUYER DATA:
Name:
Address:
Phone number:
Defect description:
Signature for acceptance of the above mentioned warranty conditions
✁
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