alvita S150 User manual

Rossmax Swiss GmbH, Tramstrasse 16, CH-9442 Berneck, Switzerland
Alvita®UK, 43 Cox Lane, Chessington, Surrey KT9 1SN
Alvita®France, (tel. [phone])
Alvita®Kundenservice Deutschland, Telefon [phone]
Alvita®Italia, Numero verde 800-094242
Alvita®España, Av. Verge de Montserrat, 6 08820 El Prat de Llobregat, Barcelona
[email protected]
Alvita®Portugal, Rua Eng. Ferreira Dias, 728 - 3º Piso Sul – 4149 014 Porto
(tel. [phone])
ALV4725/0
Blood Pressure Monitor – Wrist
Tensiomètre de poignet
Blutdruckmessgerät Handgelenk
Sfigmomanometro da Polso
Tensiómetro de muñeca
Tensiómetro de Pulso

32
Attention: Consult the accompanying documents.
Please read this manual carefully before use. For
specific information on your own blood pressure,
contact your physician. Please be sure to keep this
manual.
CONTENTS
Introduction 3
Product features 6
Using your Alvita Blood Pressure Monitor 9
a.How to apply the cu
b.Measurement procedure
c.How to use the memory
d.Battery Installation
Troubleshooting 14
Specifications 18
Introduction
What is blood pressure?
Your heart acts as a pump to circulate blood around
your body and help supply it with oxygen. Blood
pressure is the force needed for the heart to push
blood through the arteries. The highest pressure in this
cycle is when the heart contracts, this is called the
SYSTOLIC BLOOD PRESSURE. Between contractions,
the heart relaxes and blood flows into it since it is at
its lowest pressure, which is called DIASTOLIC BLOOD
PRESSURE.
Both blood pressure measurements, the systolic and
diastolic, are necessary to enable a doctor to evaluate
the status of a patient’s blood pressure.
Many factors such as physical activity, anxiety, or simply the
time of day, can influence your blood pressure.
Drinking caeine (in tea or coee) can also temporarily raise
your blood pressure, as can the nicotine in cigarettes.
Blood pressure can also follow a daily pattern, varying from
minute to minute and typically being at its lowest while we
are asleep. These variations are even more pronounced in
patients with high blood pressure.
Blood pressure is measured in millimetres of mercury (mmHg)
and measurements are written with the systolic pressure
before the diastolic e.g. a blood pressure written as 120/80 is
referred to as 120 over 80.
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54
Pulse Rate
This blood pressure monitor also measures your pulse rate.
Your pulse reflects your heart rate and is measured in terms
of the numbers of beats per minute. Pulse rate varies from
minute to minute, and is aected by many things, including
exercise, stress, anxiety, certain medicines and some foods.
Why is it beneficial to measure your blood pressure
at home?
Monitoring your blood pressure at home gives you the
advantage of taking blood pressure measurements at fixed
times of the day, in familiar surroundings, without external
influences. As a variety of conditions aect blood pressure,
a single measurement is not sucient for an accurate
diagnosis. Home monitoring enables measurements to be
taken over the course of weeks and helps to identify an
ongoing trend.
Here are a few tips to help you obtain more accurate
measurements:
Blood pressure changes with every heartbeat and varies
throughout the day. The measurements that you obtain from
this blood pressure monitor will dier as a result.
•Blood pressure recording can be aected by the position of
the user, his or her physiological condition and other
factors. For greatest accuracy, wait one hour after
exercising, bathing, eating, drinking beverages with alcohol
or caeine, or smoking to measure blood pressure.
•Before measurement, it’s suggested that you sit quietly for
at least 5 minutes as measurement taken during a relaxed
state will have greater accuracy. You should not be
physically tired or exhausted while taking a measurement.
•
Do not take measurements if you are under stress or tension.
•During measurement, do not talk or move your arm or hand
muscles.
•Take your blood pressure at normal body temperature.
If you are feeling cold or hot, wait a while before taking a
measurement.
•If the monitor is stored at very low temperature (near
freezing), have it placed at a warm location for at least one
hour before using it.
•Wait 5 minutes before taking the next measurement.
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76
Accreditation
This unit has been validated in accordance with requirements
set by the European Society of Hypertension (ESH). This
protocol tests the accuracy of blood pressure monitors to
ensure measurements are comparable to those obtained by
trained medical professionals
Comfort Inflation Technology
The unit will only inflate as high as necessary to provide
greater comfort. It uses the oscillometric method to detect
your blood pressure. Before the custarts inflating, the
device will establish a baseline cupressure equivalent to
the air pressure. This unit will determine the appropriate
inflation level based on pressure oscillations, followed by
cudeflation. During the deflation of the wrist cu, the
monitor is detecting the pressure oscillations generated by
the beat-to-beat pulsatile. Any muscle movement during this
period of time will cause measurement error. After detecting
the amplitude and the slope of the pressure oscillations
during the deflation process, your S150 will determine for
you the systolic and diastolic pressures, and your pulse rate
is detected at the same time.
During the deflation, the device will detect the amplitude
and slope of the pressure oscillations and thereby determine
for you the systolic blood pressure, diastolic blood pressure,
and pulse.
Product Features
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5
2
4
3
1
1. Pulse Indicator
2. Weak Battery Indicator
3. Memory Sequence
4. Systolic Pressure
5. Diastolic Pressure
6. Pulse Rate
3
1
2
4
5
6
1. LCD Display
2. Wrist Cu
3. Battery Cover
4. ON/OFF/START Button
5. Memory Button
2 “AAA” size,
1.5V batteries

98
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Hypertension Risk
Hypertension can be classified into 4 stages
1
.
Systolic
Pressure
Diastolic
Pressure
Normal <120 And <80
Suspected Hypertension 120~139 Or 80~89
Suspected
Stage 1 hypertension
140~159 Or 90~99
Suspected
Stage 2 hypertension
≥160 Or ≥100
These blood pressure classifications are based on historical
data, and may not be directly applicable to any particular
patient. It is important that you consult with your physician
regularly. Your physician will tell you your normal blood pressure
range as well as the point at which you will be considered at
risk. For reliable monitoring and reference of blood pressure,
keeping long-term records is recommended.
1As defined by The United States National High Blood Pressure Education Program
Coordinating Committee (7th report of the Joint National Committee on Prevention,
Detection, Evaluation, and Treatment of High Blood Pressure-Complete Report
JNC-7, 2003).
Applying the Cu
1. Remove all watches, jewellery,
etc. prior to attaching the wrist
monitor. Clothing sleeves should
be rolled up and the cushould be
wrapped on bare skin for correct
measurements.
2. Apply the cuto your left wrist
with your palm facing up as shown
in fig. 1.
3. Make sure the edge of the cu
is about 1 cm from the palm as
shown in fig. 2.
4. In order to ensure accurate
measurements, fasten the velcro
strap securely around your wrist
so there is no extra space between
the cuand the wrist as shown
in fig. 3. If the cuis not wrapped
tight enough, the measurement
values may be inaccurate.
5. If your physician has diagnosed
you with poor circulation in your
left arm, carefully place the cu
around your right wrist as shown
in fig. 4.
M
M
Using your Alvita Blood Pressure Monitor
1
2
3
4

1110
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5
6
7
Correct Measuring Posture
1. Place your elbow on a table so
that the cuis at the same level
as your heart as shown in fig. 5.
Note: Your heart is located slightly
below your armpit and slightly to
the left of the middle of your chest.
Relax your entire body, especially
the area between your elbow and
fingers.
2. If the cuis not at the same
level as your heart or if you can
not keep your arm completely still
throughout the measurement,
use a soft object such as a folded
towel to support your arm as fig. 6.
Do not allow hard objects to come
in contact with the wrist cu.
3. Turn your palm upwards.
4. Sit upright in a chair, and take
5-6 deep breaths. Avoid leaning
back while the measurement is
being taken as fig. 7.
Measurement Procedures
1. Press the ON/OFF/START button. All digits will light up,
checking the display functions. The checking procedure
will complete in 2 seconds.
2. After all symbols appear, the display will show a flashing
“0”. At this time, the monitor is ready to measure.
3. The monitor will automatically inflate to approximately 180
mmHg and measurement will begin.
4. When the measurement is completed, systolic blood
pressure, diastolic blood pressure, and pulse will be
shown simultaneously and be saved automatically in the
memory system.
Press the ON/OFF/START button to turn the monitor o. If
no button is pressed, the monitor will automatically shut o
after 1 minute.
This monitor will re-inflate automatically to approximately
220 mmHg if the system detects that your body needs more
pressure to measure your blood pressure.
Note:
1. To interrupt the measurement, simply press ON/OFF/START
button or Memory button; the cuwill deflate immediately.
2. During the measurement, do not talk or move your arm or
hand muscles.

1312
Recalling values from memory
1. To recall stored blood pressure measurements from
memory, simply press the Memory button. The last
measurement will be shown first. Every new press of the
Memory button recalls the previous measurement stored.
Note: The memory bank can store up to 90 measurements per
memory zone. When the number of measurements exceeds 90,
the oldest data will be replaced with the new measurement
Clearing Values from Memory
1. The data in the memory will not be lost when the Blood
Pressure Monitor is switched o.
2. You can erase the memories stored by:
a. Remove the batteries
b. Press and hold the memory button for more than 5
seconds
3. The data in the memory zone can be erased if any of the
batteries are removed. It is recommended that users
record their measurements in a log book before replacing
the batteries.
Battery Installation
1. Open the battery cover in the right direction. Install battery
in the right position. Battery Type: 2 AAA size. Replace the
cover and click in the other end to secure the battery cover.
2. Replace the batteries in pairs.
3. Remove batteries when unit is not in use for extended
periods of time.
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You need to replace the batteries when
1. The low battery icon appears on display.
2. The ON/OFF/START button is pressed and nothing appears
on the display.
Caution:
1. Batteries are hazardous waste. Do not dispose them
together with the household garbage.
2. There are no user serviceable parts inside. Batteries or
damage from old batteries are not covered by warranty.
3. Always use branded batteries. Always replace all of the
batteries at the same time. Use batteries of the same
brand and same type.

1514
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Troubleshooting
Display Explanations
EE / Measurement Error: Measure again. Wrap the cu
correctly and keep wrist steady during measurement. If
the error keeps occurring, return the device to your local
distributor or service centre.
E1 / Air Circuit Abnormality: Measure again. If the error
keeps occurring, return the device to your local distributor or
service centre.
E2 / Pressure Exceeding 300 mmHg: Switch the unit o
and measure again. If the error keeps occurring, return the
device to your local distributor or service centre.
E3 / Data Error: Remove and reload the batteries. If the er-
ror keeps occurring, return the device to your local distributor
or service centre.
Er / Exceeding Measurement Range: Measure again.
If the error keeps occurring, return the device to your local
distributor or service centre.
If any abnormality arises during use, please check the
following points.
Symptoms Check Points Correction
No display when the
ON/OFF/START button
is pressed
Have the batteries
run down?
Replace them with
new batteries.
Have the batteries’
polarities been
positioned
incorrectly?
Re-insert the
batteries in the
correct positions.
EE mark shown on
display or the blood
pressure value is
displayed excessively
low or high
Is the cupositioned
correctly?
Wrap the cu
properly so that
it is positioned
correctly.
Did you talk or move
during measurement?
Measure again.
Keep arm
steady during
measurement.
Did you vigorously
shake the cuduring
measurement?
Note: If the unit still does not work, return it to your
pharmacist. Under no circumstance should you disassemble
and repair the unit by yourself.

1716
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Cautionary Notes
1. The unit contains high-precision assemblies. Therefore,
avoid extreme temperatures, humidity, and direct
sunlight. Avoid dropping or strongly shocking the main
unit, and protect it from dust.
2. Clean the blood pressure monitor body and the cu
carefully with a slightly damp, soft cloth. Do not press.
Do not wash the cuor use chemical cleaner on it.
Never use thinner, alcohol or petrol (gasoline) as cleaner.
3. Leaky batteries can damage the unit. Remove the
batteries when the unit is not used for a long time.
4. The unit should not be operated by children so to avoid
hazardous situations.
5. If the unit is stored near freezing, allow it to acclimate at
room temperature before use.
6. This unit is not field serviceable. You should not use any
tool to open the device nor should you attempt to adjust
anything inside the device. If you have any problems,
please contact the store or the doctor from whom you
purchased this unit.
7. As a common issue for all blood pressure monitors using
the oscillometric measurement function, the device may
have diculty in determining the proper blood pressure
for users diagnosed with common arrhythmia (atrial or
ventricular premature beats or atrial fibrillation), diabetes,
poor circulation of blood, kidney problems, or for users
suered from stroke, or for unconscious users.
8. To stop operation at any time, press the ON/OFF/START
button, and the air in the cuwill be rapidly exhausted.
9. Once the inflation reaches 300 mmHg, the unit will start
deflating rapidly for safety reasons.
10. Please note that this is a home healthcare product only
and it is not intended to serve as a substitute for the
advice of a physician or medical professional.
11. Do not use this device for diagnosis or treatment of
any health problem or disease. Measurement results
are for reference only. Consult a healthcare professional
for interpretation of pressure measurements. Contact
your physician if you have or suspect any medical
problem. Do not change your medications without the
advice of your physician or healthcare professional.
12. Electromagnetic interference: The device contains
sensitive electronic components. Avoid strong electrical
or electromagnetic fields in the direct vicinity of the
device (e.g. mobile telephones, microwave ovens
These may lead to temporary impairment of
measurement accuracy.
13. Dispose of device, batteries, components and
accessories according to local regulations.
14. This monitor may not meet its performance specification
if stored or used outside temperature and humidity
ranges specified in Specifications.
Store between 10 – 90% RH
10m90RH
Store between 700 – 1060hPa
700n1060hPa

1918
Blood pressure measurements determined with S150 are
equivalent to those obtained by a trained observer using cu/
stethoscope auscultation method, within the limits prescribed
by the American National Standard, Electronic or Automated
Sphygmomanometers. This unit is to be used by adult
consumers in a home environment. Do not use this device on
infants or babies.
Power source DC 3V Two AAA batteries
Measurement
Method
Oscillometric
Measurement
Range
Pressure: 30~260 mmHg;
Pulse: 40~199 beats/ minute
Accuracy Pressure: ± 3mmHg;
Pulse: within ±5% of measurement
Pressure Sensor Semi conductor
Inflation Pump Driven
Deflation Automatic Pressure release valve
Memory capacity 90 memories
Auto-shut-o1 minute after last button operation
Operation
Environment
10°C~40°C (50°F~104°F);
40%~85% RH; 700~1060 hPa
Storage and
Transportation
Environment
-10°C~60°C (14°F~140°F);
10%~90% RH; 700~1060 hPa
Dimensions 82(L) x 69(W) x 66(H) mm
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Specifications Weight 115g (w/o batteries)
Wrist
circumference
13.5~22cm (5.3”~8.7”)
Cumaterials Outer fabric: Nylon
Air bag: PVC
Limited Users Adult users
Type BF: Device and cuare designed to
provide special protection against electrical
shocks.
IP Classification IP22: Protection against harmful ingress of
water and particulate matter
*Specifications are subject to change without notice.
This Blood Pressure Monitor complies with the European regulations and bears the
CE mark “CE 0120”. The quality of the device has been verified and conforms to the
provisions of the EC council directive 93/42/EEC (Medical Device Directive), Annex I
essential requirements and applied harmonized standards.
EN 1060-1: 1995/A2: 2009 Non-invasive sphygmomanometers -
Part 1 - General requirements
EN 1060-3: 1997/A2: 2009 Non-invasive sphygmomanometers -
Part 3 - Supplementary requirements for electro-mechanical blood pressure
measuring systems
EN 1060-4: 2004 Non-invasive sphygmomanometers -
Part 4: Test Procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers.
This blood pressure monitor was designed for long service time. To ensure accurate
measurements, this monitor is recommended to be re-calibrated every 2 years.

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EMC guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration-electromagnetic emissions
The S150 is intended for use in the electromagnetic environment specified below. The
customer or the user of the S150 should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The S150 uses RF energy only for its internal
function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The S150 is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaration-electromagnetic immunity. The S150 is
intended for use in the electromagnetic environment specified below. The customer or
the user of the S150 should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment-
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-4
± 2kV for power
supply lines
± 1kV for input/
output lines
Not
applicable
Not
applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1kV line(s)
to line(s)
± 2kV line(s)
to earth
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 line
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0,5 cycle
40% UT (60%
dip in UT)
for 5 cycles
70% UT (30%
dip in UT)
for 25 cycles
<5% UT (>95%
dip in UT)
for 5 s
Not
applicable
Not
applicable
Not
applicable
Not
applicable
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the S150 requires
continued operation during
power mains interruptions,
it is recommended that the
S150 be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristics of a typical
location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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2322
Guidance and manufacturer’s declaration-electromagnetic immunity
The S150 is intended for use in the electromagnetic environment specified below. The
customer or the user of the S150 should assure that is used in such and environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment-
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 KHz to
80 MHz
3 V/m
80MHz to
2,5 GHz
Not
applicable
3 V/m
Portable and mobile RF
communications equipment
should be used no closer
to any part of the S150,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
d = 1,2 √P, d = 1,2 √P
80MHz to 800 MHz, d = 2,3
√P 800MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (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:
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the
S150 is used exceeds the applicable RF compliance level above, the S150 should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the S150.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
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2524
Recommended separation distance between portable and mobile RF communications
equipment and the S150
The S150 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the S150 can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the S150 as
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150kHz to
80MHz /
d=1,2√P
80MHz to
800MHz /
d=1,2√P
800MHz to 2,5GHz / d=2,3√P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reflection from structures, objects and people.
WARNING: The symbol on this product means that it’s an electronic product
and following the European directive 2012/19/EU the electronic products have to be
dispose on your local recycling centre for safe treatment.
This instrument is covered by a 2 year guarantee from the date of purchase.
Batteries, cuand wearing parts are not included. Opening or altering the instrument
invalidates the guarantee. The guarantee does not cover damage, accidents or non-
compliance with the instruction manual. Please contact your pharmacist.
S150 is protected against manufacturing defects by an established International
Warranty Program. For warranty information, you can contact your pharmacist.
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151150
Blood Pressure Log / Fiche de suivi de votre tension
artérielle / Blutdruckprotokoll / Registro della pressione
arteriosa / Cuaderno de registro de la presión arterial /
Registo de medição da pressão arterial
mmHg
220
200
180
160
140
120
100
80
60
Pulse/Pouls/
Puls/Pulsazioni/
Pulsaciones/
Pulsação
Blood Pressure Log / Fiche de suivi de votre tension
artérielle / Blutdruckprotokoll / Registro della pressione
arteriosa / Cuaderno de registro de la presión arterial /
Registo de medição da pressão arterial
mmHg
220
200
180
160
140
120
100
80
60
Pulse/Pouls/
Puls/Pulsazioni/
Pulsaciones/
Pulsação