alvita CG155f User manual

3
Blood Pressure Monitor – Arm
Tensiomètre de bras
Blutdruckmessgerät Oberarm
Sfigmomanometro da Braccio
Tensiómetro de brazo
Tensiómetro de Braço
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])
ALV4723/0

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 5
Using your Alvita Blood Pressure Monitor 8
a. How to apply the cu
b. Measurement procedure
c. How to use the memory
d. Battery Installation
Troubleshooting 12
Specifications 14
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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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.
4“AAA” size,
1.5V batteries
1. Movement Indicator
2. Hypertension Risk Indicator
3. Weak Battery Indicator
4.
Irregular Heartbeat Detection (IHB)
5. Memory Indicator
6. Memory Average Symbol
7. Systolic Pressure
8. Diastolic Pressure
9. Pulse Rate
10. Pulse Indicator
1
2
3
4
5
6
1
2
3
4
5
6
7
8
9
10
1. Arm Cu
2. LCD Display
3. Air Tube and Connector
4. Memory Button
5. ON/OFF/START Button
6. Battery Cover
Product Features
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Hypertension Risk Indicator
Hypertension can be classified into 4 stages1. This unit is equipped with an
innovative hypertension risk indicator, which visually indicates the assumed
risk level.
Systolic Pressure Diastolic Pressure
Normal <120 And <80
Prehypertension 120~139 Or 80~89
Stage 1 hypertension 140~159 Or 90~99
Stage 2 hypertension ≥160 Or ≥100
This blood pressure classification is 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
Average measurement display
When recalling stored blood pressure measurements from the memory, the
first measurement displayed is the average of the last three measurements.
Universal Cu
This monitor is supplied with a universal cu which fits most adult arm sizes
(24-40cm).
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Accreditation
This unit has been validated in accordance with requirements set by the
European Society of Hypertension (ESH) and British Hypertension Society
(BHS). These protocols test the accuracy of blood pressure monitors to
ensure measurements are comparable to those obtained by trained medical
professionals
Movement Detection
The “Movement Detection” helps to remind the user to remain still and
indicates any body movement during the measurement procedure. The
specified icon appears once a “body movement” has been detected during and
after each measurement.
Note: It’s highly recommended that you measure again if the icon appears.
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, 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.
Irregular Heartbeat (IHB) Detection
This unit is equipped with an Irregular Heartbeat (IHB) Detection which allows
those who have an irregular heartbeat to obtain accurate measurements
alerting the user of the presence of an irregular heart beat during the
measurement.
Note: It is strongly recommended that you consult your physician if the IHB icon
appears often.

98
How to apply the cu
1. Unwrap the arm cu, leaving the
end of the cu through the D-ring of
the cu.
2. Put your left arm through the
cu loop. The colour strip indication
should be positioned closer to you
with the tube pointing in the direction
of your arm (Fig. 1). Turn your left
palm upward and place the edge of
the arm cu approximately 1.5 to 2.5
cm above the inner side of the elbow
joint (Fig. 2). Tighten the cu by
pulling the end of the cu.
3. Centre the tube over the middle
of the arm. Press the hook and loop
material together securely. Allow
room for 2 fingers to fit between the
cu and your arm. Position the artery
mark over the main artery (on the
inside of your arm) (Fig. 3,4). Note:
Locate the main artery by pressing
with 2 fingers approximately 2 cm
above the bend of your elbow on the
inside of your left arm. Identify where
the pulse can be felt the strongest.
This is your main artery.
Using your Alvita Blood Pressure Monitor
4. Plug in the cu connecting tube
into the unit (Fig. 5).
5. Lay your arm on a table (palm
upward) so the cu is at the same
height as your heart. Make sure the
tube is not kinked (Fig. 6).
6. This cu is suitable for your use if
the arrow falls within the solid colour
line as shown on the right (Fig. 7).
1
5
6
7
2
3
4
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Measurement Procedures
1. Press the ON/OFF/START button. All displays will appear for approximately
one second before returning to “0”.
2. The unit will automatically inflate to the appropriate inflation level based on
yours pulse oscillations. Measurement will then begin. It is important
to remain still and quiet during measurement. Any significant movement
may aect measurement results.
3. When the measurement is completed, systolic, diastolic and pulse will be
shown simultaneously and be saved automatically in memory system. Up to
90 measurements can be saved.
4. Press the ON/OFF/START button to turn the monitor o. If no button is
pressed, the unit will shut o automatically in 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 the Memory or ON/OFF/START
button; the cu will deflate immediately.
2. During the measurement, do not talk or move your arm or hand muscles.
How to use the memory
Recalling values from memory
1. To recall stored blood pressure measurements from memory, simply press
the Memory button, the first measurement displayed is the average of the
last 3 measurements stored in memory, and then the last set of memorized
measurements will be displayed.
2. Another press of the Memory button will recall the previous set of
measurements.
3. All measurements stored in memory will be displayed with its sequence
number.
Clearing Values from Memory
Press and hold the Memory button for approximately 5 seconds, then the data
in the memory zone can be erased automatically.
Battery Installation
1. Press down and lift the battery cover in the direction of the arrow to open the
battery compartment.
2. Install or replace 4 “AAA” sized batteries in the battery compartment
according to the indications inside the compartment.
3. Replace the battery cover by clicking in the bottom hooks first, then push in
the top end of the battery cover.
4. Replace all the batteries at the same time. Remove batteries when unit is
not in use for extended periods of time.
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.
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1312
Troubleshooting
Display Explanations
EE / Measurement Error: Make sure the L-plug is securely connected to the
air socket and measure again quietly. Wrap the cu correctly and keep arm
steady during measurement. If the error keeps occurring, return the device to
your pharmacist.
E1 / Air Circuit Abnormality: Make sure the L-Plug is securely connected to
the air socket on the side of the unit and measure again quietly. If the errors
still occur, return the device to your pharmacist for help.
E2 / Pressure Exceeding 300 mmHg: Switch the unit o and measure again
in the appropriate conditions described above. If the error keeps occurring,
return the device to your pharmacist
E3 / Data Error: Remove the batteries, wait for 60 seconds, and reload. If the
error keeps occurring, return the device to your pharmacist.
Er / Exceeding Measurement Range: Measure again in the appropriate
conditions described above. If the error keeps occurring, return the device to
your pharmacist.
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.
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.
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1514
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
Specifications
Blood pressure measurements determined with CG155f 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.
Measurement Method Oscillometric
Measurement Range Pressure: 30~260 mmHg; Pulse: 40~199 beats/ minute
Pressure Sensor Semi conductor
Accuracy Pressure: ± 3mmHg; Pulse: ± 5% of measurement
Inflation Pump Driven
Deflation Automatic Air 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
DC Power Source DC 6V four AAA Batteries
Dimensions 124 (L) X 85 (W) X 68.6 (H) mm
Weight 330g (G.W.) (w/o Batteries)
Arm circumference Adult: 24~40 cm (9.4”~15.7”)
Composition du brassard Tissu extérieur : Nylon
Poche d’air : PVC
Tube : PVC
Connecteur : ABS
Limited Users Adult users
Type BF: Device and cu are designed to provide special protection
against electrical shocks.
IP Classification IP21: 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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1716
Guidance and manufacturer’s declaration-electromagnetic immunity. The CG155f is intended for use in the
electromagnetic environment specified below. The customer or the user of the CG155f 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 CG155f
requires continued operation during power
mains interruptions, it is recommended
that the CG155f 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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EMC guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration-electromagnetic emissions
The CG155f is intended for use in the electromagnetic environment specified below. The customer or the
user of the CG155f should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The CG155f 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 CG155f 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

1918
Recommended separation distance between portable and mobile RF communications equipment and the
CG155f
The CG155f is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the CG155f can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the CG155f 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.
CG155f is protected against manufacturing defects by an established International Warranty Program.
For warranty information, you can contact your pharmacist.
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Guidance and manufacturer’s declaration-electromagnetic immunity
The CG155f is intended for use in the electromagnetic environment specified below. The customer or the
user of the CG155f 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 CG155f, 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 CG155f is used exceeds the applicable RF compliance level above, the CG155f should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the CG155f.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

111110
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