Plusmed PM-B51 PLUS User manual

www.plusmed-health.com
Model:pM-B51 Plus
Blood Pressure Monitor - Wrist Automatic
Otomatik Tansiyon Aleti - Bilek Tipi
Kullanım Kılavuzu
Instruction Manual

Wrist Watch Blood Pressure Monitor
Instruction Manual
Wrist cuff is suitable for wrist circumference of 12.5 to 21.5 cm
PLUSMED PM-B51 PLUS

Table of contents
1. Introduction
1.1. Features of the PLUSMED PM-B51 PLUS
1.2. Important information about self-measurement
2. Important information on the subject of blood-pressure and its measurement
2.1. How does high/low blood-pressure arise?
2.2. Which values are normal?
3. Putting the blood-pressure monitor into operation
3.1. Inserting the batteries
3.2. Reading the set date
3.3. Setting the time and date and user selection
3.3.11. how to select pressure unit , switchable of mmHg and kPa
4. Carrying out a measurement
4.1. Before the measurement
4.2. Common sources of error
4.3. Fitting the cuff
4.4. Measuring procedure
4.5. Discontinuing a measurement
4.6. Memory – storage and recall of the measurements
4.7. Memory full
4.8. Memory – cancellation of all measurements
5. Appearance of the Heart Arrhythmia Indicator for early Detection
6. Error messages / malfunctions
7. Care and maintenance, recalibration
8. Guarantee
9. Service life
10. Battery life
11. Safety, Care and Disposal
12. Reference to standards
13. Technical specifications
14. Manufacturer's Declaration

1. Introduction
1.1. Features of the PLUSMED PM-B51 PLUS
The blood-pressure monitor PLUSMED PM-B51 PLUS (with integrated time/date display) is a
fully automatic, digital blood-pressure measuring device for use on the wrist, which enables
very fast and reliable measurement of the systolic and diastolic blood-pressure as well as the
pulse frequency by way of the oscillometric method of measuring. The device offers a very
high and clinical tested measurement accuracy and has been designed to provide a maximum
of user-friendliness. The device is intended for self-use in home .
Before using, 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 self-measurement
•Substitution of a different component might result in measurement error.
•Do not use with neonatal patients.
•Do not intend to use with pregnant or pre-eclamptic patients
•Too frequent measurements can cause injury to the patient due to blood flow interference.
•The application of the cuff over a wound can cause further injury.
•The application of the cuff and its pressurization on any limb where intravascular access or
therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood
flow and could result in injury to the patient.
•Do not let the device and its pressurization on the side of a mastectomy
• Pressurization of the cuff can temporarily cause loss of function of simultaneously used
monitoring ME equipment on the same limb.
•The need to check that operation of the automated sphygmomanometer does not result in
prolonged impairment of patient blood circulation.
•Not intended to be used together with HF surgical equipment.
• 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 prescribed by your doctor.
• The pulse display is not suitable for checking the frequency of heart pacemakers!
• In cases of cardiac irregularity (Arrhythmia), measurements made with this instrument
should only be evaluated after consultation with the doctor.
3

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 cookers). These can lead to temporary impairment 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 circulatory
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) 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 diastolic pressure is above 90 mmHg and/or the
systolic blood-pressure is over 160 mmHg. 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 140 mmHg and 160 mmHg and/or the
diastolic blood-pressure values lie between 90 mmHg and 100 mmHg, likewise, please consult
your doctor. Furthermore, regular self-checks will be necessary.
With blood-pressure values that are too low, i.e. systolic values under 100 mmHg and/or
diastolic values under 60 mmHg, likewise, please consult your doctor.
Even with normal blood-pressure values, a regular self-check with your blood-pressure
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-measurements 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
prescribed by your doctor.
4

Table for classifying blood-pressure values (unit: mmHg) according to World Health
Organization:
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 require immediate
medical treatment.
3. Putting the blood-pressure monitor into operation
3.1. Inserting the batteries
a) Insert the batteries (2 x size AAA 1.5V), thereby observing the indicated polarity.
b) If the battery warning appears in the display, the batteries are empty and must be
replaced by new ones.
Attention!
• After the battery warning appears, the device is blocked until the batteries have been
replaced.
• Please use «AAA» Long-Life or Alkaline 1.5V Batteries. The use of 1.2V Accumulators is not
recommended.
• If the blood-pressure monitor is left unused for long periods, please remove the batteries
from the device.
3.2. Reading the set date
Please press the TIME button . The date will be shown in the display.
Range
Systolic
Diastolic
Measures
Blood-pressure
Blood-pressure
Hypotension
lower than 100
lower than 60
Consult your doctor
Blood pressure optimum
between 100 and 1 20
between 60 and 80
Self -check
Blood pressure normal
between 120 and 130
between 80 and 85
Self -check
Blood pressure slightly high
between 130 and 140
between 85and 90
Consult your doctor
Blood pressure too high
between 140 and 160
Between 90and 100
Seek medical advice
Blood pressure far too high
between 160 and 180
Between 100and 110
Seek medical advice
Blood pressure dangerously
high
H igher than 180
H igher than 110
Urgently seek medical advice!
5

3.3. User selection and setting the time, date,
User selection:
This advanced blood pressure monitor allows you to track blood pressure readings for 2
individuals independently.
a) Before measurement, make sure you set the unit for
the intended user. The unit can track results for 2 individuals. (User 1, User 2)
b) Press the TIME button for at least 3 seconds.
The display now indicates the set user, during
which the set user blink. To confirm , press ON/OFF button.
c) Click the MEMORY button to select User
d) We suggest the first person to take their
pressure to be User 1.
Setting the time, date
This blood-pressure monitor incorporates an integrated clock with date display. This has the
advantage, that at each measurement procedure, not only the blood-pressure values are
stored, but also the exact moment of the measurement.
After new batteries have been inserted, the clock begins to run from the following setting:
2010-06-20 09:30 O’clock.
You must then re-enter the date and current time. For this, please proceed as follows
1) Press the TIME button for at least 3 seconds firstly , user icon blink .
Then press TIME button again the display now indicates the set year, during which the four
characters blink.
2) The correct year can be entered by pressing the MEMORY button.
6

3) Press the TIME button again. The display now
switches to the current date, during which the first
character (month) blinks.
4) The corresponding month can now be entered by
pressing the MEMORY button.
5) Press the TIME button again. The last two
characters (day) are now blinking
6) The corresponding day can now be entered by
pressing the MEMORY button.
7) Press the TIME button again. The display now
switches to the current time, during which the first
character (Hour) blinks.
8) The corresponding hour can now be entered by
pressing the MEMORY button.
9) Press the TIME button again. The last two characters
(Minutes) now blink.
10) The exact time can now be entered by pressing the
MEMORY button.
11) How to select pressure unit , switchable of mmHg and kPa, Finished the whole setting
process mentioned above , Press the TIME button again, Display “mmHg” blink,
7

To press “ MEMORY” button can switch “
pressure unit as “mmHg” or “Kpa”, To press
the TIME button selects pressure unit.
12) Now after all settings have been made, press the
TIME button once again. The date is briefly displayed
and then the time. The input is now confirmed and the
clock begins to run.
Further Information
With each press of the button (TIME, MEMORY)
one input is made (e.g. switching over from hours
to minutes mode, or altering the value by +1).
However, if you keep the respective button depressed, you can switch more quickly to find the
desired value respectively.
4. Carrying out a measurement
4.1. 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.
• Measure always on the same wrist (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.
4.2. Common sources of error:
Note:
Comparable blood-pressure measurements always require the same conditions! These
are normally always quiet conditions.
• All efforts by the patient to support the wrist 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 . Use a cushion for support if necessary.
8

•The performance of the automated sphygmomanometer can be affected by extremes of
temperature, humidity and altitude.
• If the wrist artery lies considerably lower (higher) than the heart, an erroneously higher
(lower) blood-pressure will be measured! (Each 15cm difference in height results in a
measurement error of 10mmHg!)
• A loose cuff causes false measurement values.
• With repeated measurements, blood accumulates in the respective wrist which can lead to
false results. Correctly executed blood-pressure measurements should therefore first be
repeated after a 5 minute pause or after the wrist has been held up in order to allow the
accumulated blood to flow away (after at least 3 minutes).
4.3. Fitting the cuff
a) Remove all eventual objects and jewellery (e.g. wristwatch)
from the wrist in question. Draw the cuff over the wrist.
b) The distance between the cuff and the hand should be approx. 10 mm.
c) Secure the cuff with the Velcro fastener, so that it lies
comfortably and not too tight, whereby no space should
remain between the cuff and the wrist.
d) Lay the arm on a table, with the palm upwards. Support
the arm a little with a rest (cushion), so that the cuff rests
at about the same height as the heart. Take care, that the
cuff lies free. Remain so for 2 minutes sitting quietly,
before beginning with the measurement.
e) Let legs uncrossed, feet flat on the floor, back and arm supported.
4.4. Measuring procedure
After the cuff has been appropriately positioned, the measurement can begin:
a) Press the ON/OFF button, the pump begins to inflate the cuff.
In the display, the increasing cuff-pressure is continually displayed.
b) After reaching the inflation pressure, the pump
stops and the pressure slowly falls away. The cuffpressure (large
characters) is displayed during the measurement. When the device
has detected the pulse, the heart symbol in the display begins to
blink for every pulse beat.
9

c) When the measurement has been concluded,
The measured systolic and diastolic blood-
pressure values as well as the pulse frequency are now displayed.
Example (Fig.): Systole 118, Diastole 73, Pulse 75
The measurement results are displayed, until you switch the device off. If no button is pressed
for 3 minutes, the device switches automatically off, to save the batteries.
4.5. Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement
for any reason (e.g. the patient feels unwell), the “ ON/OFF ” button
can be pressed at any time. The device then immediately
lowers the cuff-pressure automatically.
4.6. Memory – storage and recall of the measurements
The blood-pressure monitor automatically stores each of the
last 120 measurement values.
By pressing the MEMORY button, an average value of the last
3 measurements as well as the last measurement (MR1) and the
further last 120 measurements (MR2, MR3, ..., MR120) can be displayed
one after the other.
(MR1: Values of the oldest measurement)
(MR2-MR120: Values of the measurement before MR1)
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4.7. Memory full
Pay attention that the maximum memory capacity is not exceeded.
When the memory is full, the old values are automatically
Overwritten with new ones.
When memory is full , the display shown 1 second as follows
to remind you “ memory full “
4.8. Memory– cancellation of all measurements Attention!
Before you delete all readings stored in the memory, make sure you will not
need refer to the readings at a later date. Keeping a written record is prudent
and may provide additional information for your doctor’s visit.
In order to delete all stored readings, depress the MEMORY
button for at least 5 seconds, the display will show the symbol
«CL» and then release the button . to permanently clear the memory,
Press the MEMORY button while «CL» is flashing.
5. Appearance of the Heart Arrhythmia Indicator for early Detection
this symbol indicates that certain pulse irregularities were detected during the easurement.
In this case, the result may deviate from your normal blood pressure – repeat the measurement.
In most cases, this is no cause for concern. However, if the symbol appears on a regular basis
(e.g. several times a week with measurements taken daily) we advise you to tell your doctor.
Please show your doctor the following explanation.
Information for the doctor on frequent appearance of the Arrhythmia indicator
This instrument is an oscillometric blood pressure monitor that also analyses pulse frequency
during measurement. The instrument is clinically tested. The arrhythmia symbol is displayed after
the measurement, if pulse irregularities occur during measurement. If the symbol appears more
frequently (e.g. several times per week on measurements performed daily) we recommend the
patient to seek medical advice.
The instrument does not replace a cardiac examination, but serves to detect pulse irregularities
at an early stage
11

6. Error messages/malfunctions
If an error occurs during a measurement, the measurement is
discontinued and a corresponding error code is displayed
(Example: Error No. 2).
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:
Error No.
Possible cause(s)
ERR 1
No pulse has been detected.
ERR 2
Unnatural pressure impulses influence the mea surement result.
Reason: hand was moved during the Measurement (Artefact).
ERR 3
The inflation takes too long. The cuff is not correctly seated.
ERR 5
The measured readings indicated an unacceptable difference
between systolic and diastolic pressures. Take another reading
following di rections carefully. Contact you doctor if you continue
to get unusual readings.
ERR8
Pressure in cuff is over 290mmHg
Malfunction
Remedy
The display remains empty when
the instrument is switched on
although the batteries are in
place.
1.Check batteries for correct polarity and if
necessary insert correctly .
2.If the display is unusual, re -insert batteries or
exchange them.
The device frequently fails to
measure the blood pressure
values, or the values measured
are too low (too high).
1. Check the positioning of the cuff.
2. Measure the blood -pressure aga in in peace and
quiet under observance of the details made under
point 5.
Every measurement produces a
different value although the
instrument functions normally
and the values displayed are
normal
1. Please read the following information and the
points l isted under «Common sources of error».
Repeat the measurement.
Please note: Blood pressure fluctuates
continually so successive measurements will
show some variability.
12

Blood pressure measured differs
from those values measured by
the doctor.
1. Record the daily development of the values
and consult your doctor.
Please note:
Individuals visiting their doctor frequently
experience anxiety which can result in a
higher reading at the doctor than obtained
at home under resting conditions.
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 the
arrhythmia symbol is in the display , please consult your doctor.
For licensing, the device has been subjected to strict clinical tests, by which the computer
program used to measure the blood-pressure values was tested by experienced specialist
doctors in Germany. The same computer program is used in every individual device, and has
thus also been clinically tested.
The manufacture of the devices takes place according to the terms of the European standard
for blood-pressure measuring devices . You must consult your specialist dealer if there are
technical problems with the blood-pressure instrument. Never attempt to repair the
instrument yourself!
Any unauthorised opening of the instrument invalidates all guarantee claims!
13

7. 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) 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!
d) Do not drop the instrument or treat it roughly in
any way. Avoid strong vibrations.
e) Never open the device! Otherwise the manufacturer
calibration becomes invalid!
8. Guarantee
a) Do not expose the device to either extreme temperatures,
humidity, dust or direct sunlight.
The blood-pressure monitor PLUSMED PM-B51 PLUS is guaranteed for 2 years from date of
purchase. The guarantee does not apply to damage caused by improper handling, accidents,
not following the operating instructions or alterations made to the instrument by third parties.
The guarantee is only valid upon presentation of the guarantee card filled out by the dealer.
9. Service life
5 years
10. Battery life :
300 times measurement with 2- size “AAA” alkaline Batteries
14

11. Safety , Care and Disposal
Safety and protection
• This instrument may be used only for the purpose described in this booklet. The
manufacturer cannot be held liable for the damage caused by incorrect application.
• This instrument comprise sensitive components and must be treated with caution. Observe
the storage and operating condition described in the “Technical specifications” section !
• Protect it from
o water and moisture
o extreme temperatures
o impact and dropping
o contamination and dust
o direct sunlight
o heat and cold
• The cuffs are sensitive and must be handled with care
• Only pump up the cuff once fitted
• Do not use the instrument close to strong electromagnetic fields such as mobile telephones
or radio installations
• Do not use the instrument if you think it is damaged or notice anything unusual.
• If the instrument is not going to be used for a prolonged period the batteries should be
removed.
• Read the additional safety instructions in the individual sections of this booklet.
• Ensure that children do not use the instrument unsupervised:
• some parts are small enough to be swallowed
• Must use the recognized accessories, detachable parts and materials,
o if the use of other parts or materials can degrade minimum safety
• A warning to remove primary batteries if the instruments is not likely
o to be used for some time
Instrument care
Clean the instrument only with a soft, dry cloth
Disposal
batteries and electronic instruments must be disposed of in accordance with the locally
applicable regulations, not with domestics waste
15

12. Reference to standards
Device standard: Device corresponds to the requirements of
the European standard for non-invasive
blood- pressure monitor
EN1060-1
EN1060-3
EN1060-4 – clinical investigation
IEC/EN 60601-1-11
ANSI / AAMI SP10, NIBP,
IEC80601-2-30:2009 + corrigendum 2010
Electrical compatibility: Device fulfils the stipulations of the
IEC/EN 60601-1,
EN 60601-1-2
The stipulations of the EU-Guidelines 93/42/EEC for Medical Products Class IIa have been fulfilled.
13. Technical specifications
Measurement Procedure: Oscillometric , corresponding to Korotkoff method:
Phase I : systolic , Phase V : diastolic
Display: Digital display
Measuring range: SYS/DIA: 30 to 280 mmHg (in 1 mmHg increment)
Pulse: 40 to 200 beat/minute
Static accuracy: SYS/DIA: ±3mmHg
Pulse: ±5% of reading
Measuring resolution: 1mmHg
Inflation: Automatic inflation by internal pump
Memory function: 120 memory × 2 users(SYS, DIA, Pulse)
Decompression: Constant exhaust valve system
Power source: 2- size “AAA” alkaline Batteries
Rated voltage: DC 3V 1.5W (direct current)
Operation temperature: 5~40℃/41~104℉
Operation humidity: 15%~85%RH maximum
Storage temperature: -10~55℃/14~131℉
Cuff size: 12.5- 21.5cm
Storage humidity: 10%~95%RH maximum
Dimensions: 74 x 64 x32 ±1.0 mm
Device weight: 135g±5g (including batteries and cuff)
Batteries weight:23g±1.0g
16

storage box weight: 57g±1.0g
size of the Sys / Dia digits: 12mm
time display: 24h display
visible display size: 44*34±1.0 mm
Cuff pressure display range: 0~299mmHg/0~39.9KPa
Electrical shock protection: Internal power unit
Safety classifications: Type BF equipment
Mode of operation: Continuous operation
Protection against ingress of water: IPX0
Accessories: storage case , 2 “AAA” batteries,
instruction manual, warranty card
14.Manufacturer's Declaration
The PLUSMED PM-B51 PLUS is intended for use in the electromagnetic environment specified
below. The customer or the user of the PLUSMED PM-B51 PLUS should assure that it is used in
such an environment.Electromagnetic Emissions: (IEC60601-1-2)
Electromagnetic Immunity: (IEC60601-1-2)
Emission Test
Compliance
Electromagnetic Environment
RF emission CISPR 11
Group 1
The PLUSMED PM-B51 PLUS uses RF energy only for internal functions.
Therefore, this RF emission is extremely weak and there is little chance of it
creating any kind of interference whatsoever with nearby electronic
equipment.
RF emissions CISPR 11
Class B
The PLUSMED PM-B51 PLUS is suitable for use in all establishments,
including domestic establishments and those directly connected to the public
voltage power supply network that low supplies buildings used for domestic
purposes.
Harmonic emissions IEC
61000-3-2
Not
applicable
Voltage
fluctuations/flicker IEC
61000-3-3
Not
applicable
Immunity test
IEC60601-1-2 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 %.
Electric fast
transient/
burst IEC
61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
17

Electric fast transient/
burst IEC 61000 -4-4
±2 kV for power supply lines
±1 kV for input/output lines
Not applicable
Mains power quality should be that of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV differential mode
±2 kV common mode
Not applicable
Not applicable
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000 -4- 11
<5 % U
T
（95% dip in U
T
.）
for 0.5 cycle 40 % U
T
（60%
in U
T
）for 5 cycles
70 % U
T
(30% dip in U
T
)
<5 % U
T
（95%
dip in U
T
）for 5 sec.
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the wrist style requires continued operation
power mains interruptions, it is recommended that the
PLUSMED PM -B51 PLUS
be powered from an uninterruptible power
supply or a battery.
Power frequency
(50/ 60 Hz) magnetic field
IEC 61000-4- 8
3 A/m
Not applicable
Not applicable
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Immunity
test
IEC60601 -1-
2 test level
IEC60601 -
1-2 test
level
Electromagnetic environment - guidance
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 61000 -
4-3
3 Vrms 150
kHz to 80
MHz 80%
AM (2Hz)
3 Vrms 80
MHz to 2.5
GHz 80%
AM (2Hz)
Not
applicable
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
PLUSMED PM -B51 PLUS , including
cables, than there commended
separation distance calculate from the
equation applicable to the frequency of
the transmitter.
Recommend separation distance
3V
d = 1.2
× p
1/2
80Mhz to 8 00 MHz
d = 2.3
×
p
1/2
MHz to 2.5 GHz
where P is the maximum output power
rating of th e transmitter in watts (W)
according to he transmitter manufacturer
and d is the recom mended 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:
duringdip
for 25 cycles
18