Spengler EFFItens AMI User manual

Instruction manual - Manuel d’utilisation
Manual de instrucciones - Manuale di istruzioni
Bedienungs-anleitung - Instructiehandleiding
Automatic upper arm blood pressure monitor
Tensiom tre automatique au bras
Tensiómetro automático de brazo
Sfigmomanometro automatico da braccio
Automatisches Oberarm-Blutdruckmessgerät
Bloeddrukmeter polsmodel

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EFFItens AMI®I1
CONTENTS
Information You Should Know Before
Operating the Unit 1
About the Unit 3
Explanation of Displays 3
Preparation for Use
Installing/Replacing Batteries 4
Attaching the Pressure Cuff 4
Measuring Posture 5
Operations
Setting the Clock 6
Measuring Blood Pressure 6
Recalling Memories 8
Erasing Memories 8
Care and Maintenance 10
Error Message 11
Specifications 12
uidance and Manufacturer's
Declaration 14
INFORMATION YOU SHOULD
NOW BEFORE OPERATING THE UNIT
Caution
1. Consult your physician to verify your blood pressure
range before obtaining them at home with this unit.
2. If the cuff causes any discomfort during measure-
ment, press the power button to turn off the unit
immediately.
3. Pull off the velcro strap to detach the cuff if the
pressure is over 300mmHg and the cuff does not
deflate automatically.
Blood pressure measurements obtained with this unit
are equivalent to those obtained by a trained person
using the cuff/ stethoscope auscultation method,
within the limits prescribed by the American National.
Standard, Manual, electronic, or automated sphygmo-
manometers.
WARRANTY: Three years from the date of purchase.

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What is blood pressure?
A force is created by the heart as the ventricle forcibly
ejects blood into the blood vessels and through
the transport system. Another force is created by the
arteries as they resist the blood flow. Blood pressure
is the result of these two forces.
What are systolic and diastolic pressures?
Systolic pressure represents the highest pressure at
the height of the heart's contraction. Diastolic pres-
sure is the lowest pressure when the heart is resting.
Comparison to WHO recommendations
See the following blood pressure classification chart
released by the WHO (World Health Organization) for
evaluation of your blood pressure level.
WHO recommendations are based on historical data,
which may not be applicable to a specific patient.
Please consult your physician for further advice.
What about low blood pressure?
In general, lower blood pressure reading is better un-
less it causes some uncomfortable symptoms such as
fainting and/or lightheadedness.
Fluctuation and variation in blood pressure
The following chart shows possible blood pressure
fluctuations during a 24hr period.
Severe Hypertension (Grade 3)
Systolic mmHg
Diastolic mmHg
Moderate Hypertension (Grade 2)
Mild Hypertension (Grade 1)
Borderline
Normal
Optimal
PM AM
Systolic
Diastolic
mmHg
160
140
120
100
80
60
12 6 06 11

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The following factors will influence blood pressure
measurement results and cause variations.
• Bathing • Breathing
• Conversation • Moving
• Drinking alcohol • Meals
• Mental tension • Exercise
• Thoughts • Smoking
• Temperature change, etc...
ABOUT THE UNIT
The cuff is designed to fit arm sizes between 22 and
32cm (8.7 to 12.6 inches.)
EXPLANATION OF DISPLAYS
LCD DISPLAY
CUFF
POWER
BUTTON
MODE SELECTION
SWITCH
MEMORY BUTTON
USERS SELECTION
BUTTON
TUBING
Systolic
Diastolic
Date
Memory
Clock
Pulse Rate
Pulse
Indicator
Low Battery
Indicator
IPD (irregular
pulse detection)

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PREPARATION FOR USE
Installing/Replacing Batteries
1. Insert the batteries into the battery compartment
matching correct polarities "+" and "-".
2. Replace all batteries if the low battery indicator
appears.
3. Remove the batteries if the unit will not be used for
a long period of time.
NOTE: It is recommended that the same type of
alkaline batteries be used to avoid incompatibility.
AC Adapter (optional)
It is recommended to use an AC adapter(output 6V
DC/0.8A) to operate the device.
1. Connect the AC adapter to the socket located on
the right side of the device as shown in the figure.
Attaching the Pressure Cuff to the Unit
1. Connect the tube connector to the socket of the
unit as shown in the figure.
Attaching the Pressure Cuff around the Arm
1. Wrap the cuff around bare-skinned left arm.
4 type "AA"
batteries
AC ADAPTER

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2. Fasten the cuff. Make sure it is not too tight. The
cuff's lower edge should be approximately one inch
from the crook of the arm.
3. If it is not possible to measure on the left arm.
Attach the cuff on the right arm as shown in the figure.
Measuring Posture
1. Sit upright and ensure that the measuring site is at
heart level. Relax and measure in a natural position.
2 . Measure and record blood pressure at the same
time every day to establish your blood pressure
pattern.
1inch(2~3cm)
1inch(2~3cm)

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HOW TO OPERATE THE UNIT
1. Setting the Clock
Under power-off, press the
MEMORY button until the
display shows a blinking
year.
Press the POWER button to
adjust the year when it is
blinking.
Then press the MEMORY
button again, "month" will
appear and blink to be
adjusted, and then "date",
"hour", and "minute" will
follow as you press and
release the MEMORY button
again.
To adjust the clock
Press the POWER button to
adjust the values of
"month", "date", "hour" and
"minute" when they are
blinking.
2. Measuring Blood Pressure
2.1 Select preffered measuring mode using the
MODE SELECTION SWITCH.
2.2 Press the USER SELECTION
Button to choose the User Number for memory
storage. (The default setting is Number 1)
MOMI (AMI)
Regular

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User selection can also be made or changed by
pressing the USER SELECTION button after measu-
rement when the result is displayed on the LCD.
2.3 Press and release the POWER button to start
measuring.
2.4 When the measurement is completed ,the
display will show the measured blood pressure
value, pulse rate and user number.
2.5 Press the Power button to turn off the
unit. Otherwise it will turn off automatically after
150 seconds.
2.6 Depending on the height and color of the bar,
the readout value is either with the normal ( green),
borderline (yellow) or hypertension (red) range.
The classification corresponds to the WHO 6 ranges
recommendations, as described in page 1.
Red Yellow Green
Initial display
Measurement
Pumping
Displaying
the results

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IPD (Irregular Pulse Detection): The device can
analyse the pulse during blood pressure measure-
ment. When the IPD symbol appears,
it means more than three irregular pulses was
detected during measurement. An irregular pulse
is dened as a heartbeat pulse interval is more
than 5/3 times the average pulse interval while the
monitor is measuring the blood pressure. If the
symbol appears more frequently, please consult a
qualied physician for professional advice.
3. Recalling Memories
3.1 Press the USER SELECTION button to choose the
desired user number.
3.2 Press the MEMORY button to recall the last
stored measurement value.
3.3 Press the MEMORY button to go to previous
memories.
4. Erasing Memories
You may erase one or all records from each user's
memory section.

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To delete one record:
Step1: Press the USER SELECTION button to choose
the desired user number.
Step2: Press and release MEMORY button to display
records. Press and release MEMORY button again to
choose the record that you wish to delete.
Step3: Press and hold the START/STOP button until
the Display shows"dEL".
Step4: Press and hold the START/ STOP button. After
three beeps are heard, the selected record is deleted.
To delete all memories:
Follow steps 1 and 3 above.
Step4: Press the MEMORY button again and the
display shows "dEL ALL".
Step5: Press and hold the START/
STOP button. After three beeps
are heard, all records are deleted.

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CARE AND MAINTENANCE
Do not drop the unit.
It is not shock proof.
Do not modify or disassemble
the unit or the arm cuff.
Do not twist the arm cuff.
Use a cloth moistened with
water or neutral detergent to
clean the body of the unit and
then wipe it dry.
Avoid thinner, benzene, and
other harsh cleaners.

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CARE AND MAINTENANCE
ERROR MESSAGE
Keep the unit in a suitable
place. Avoid high temperature,
direct sunlight, high moisture,
and dust.
Remove the batteries if the
unit will not be used for a
long time.
Do not press the POWER
button if the cuff has not
been properly wrapped
around the arm.
The pressure measured was
lower than 20mmHg.
Please measure again.
The pressure measured was
higher than 300mmHg.
Please measure again.
Pumping error.
Please check cuff and try again.
Z
Z
Z

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ERROR MESSAGE
or
No display
The pressure can not be
measured due to signal noise.
Please measure again.
The pumping pressure is higher
than 300mmHg.
Please measure again.
Low battery. Check and
replace the 4 batteries if
necessary.

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SPECIFICATIONS
Display System Liquid Crystal Display
Measuring Method Oscillometric
Power Source 6Vdc; "AA" type battery x 4
Measuring 20~300mmHg
Range 40~200 Pulse/minute
Accuracy ±3 mmHg or 2% (pressure)
±5% of readings (pulse rate)
Ination Micro rolling pump
Pressure Electrical Solenoid valve
Exhaust
Memory 2x50 sets
Display LCD (year/date/time, pressure and
pulse)
Low Battery Yes
Indicator
Auto Power-Off 150 secs. w/o any operation
Battery Life Around 250 operations
Operating +10°C +40°C; RH<85%
Environment (+50°F~+104°F)
Storage -10°C +50°C; RH<85%
Environment (+14°F~+122°F)
Dimensions 142 x 138 x 63 mm
Weight Approx. 480g
(Including batteries)
Specications are subject to change for improvement
without notice.
Calibration is recommended every two years.

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GUIDANCE AND MANUFACTURER'S
DECLARATION
Portable and mobile RF communications equip-
ment can affect this device. The user of this device
needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC
information provided in the guidance provided below.
Electromagnetic Emission
The blood pressure monitor is intended for use in the
electromagnetic environment specified below. The customer
or the user of the blood pressure monitor should assure that
it is used in such an environment.
Emission Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
missions
IEC 61000-3-2
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Compliance
roup 1
Class B
Class A
Complies
Electromagnetic
Environment -
uidance
The blood pressure
monitor uses RF
energy only for its
internal function.
The refore, its RF
emissions are very
low and are not
likely to cause any
interference in
nearby electronic
equipment.
The blood pressure
monitor is suitable
for use in all
establishments other
than domestic and
those directly
connected to the
public low-voltage
power supply network
that supplies buildings
used for domestic
purposes.

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Electromagnetic Immunity
The blood pressure monitor is intended for use in the electro-
magnetic environment specified below. The customer or the
user of the blood pressure monitor should assure that it is
used in such an environment.
Immunity
Test
Electrostatic
discharge
(ESD) IEC
61000-4-2
Electrical fast
transient/b
urst
IEC 61000-
4-4
Surge
IEC 61000-
4-5
Voltage dip,
short
interruptions
and voltage
variations
on power
supply
input lines
IEC 61000-
4-11
IEC
60601
test level
±6 kV
contact
±8 kV air
±2 kV for
power
supply
lines
±1 kV
line(s) to
line(s)
<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
Compliance
level
±6 kV
contact
±8 kV air
±2kV for
power
supply
lines
±1 kV line(s)
to line(s)
<5 % U
(>95T% dip
in UT) for 0.5
cycle
40 % UT
(60 % dip
in UT) for
5 cycles
70 % UT
(30 % dip in
U ) for T
25 cycles
<5 % UT
(>95 % dip
in UT)
for 5 s
Electromagnetic
Environment -
uidance
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Mains power quality
should be that of a
typical commercial
or hospital environ-
ment. If the user of
the blood pressure
monitor requires
continued
operation during
power mains
interruptions, it is
recommended that
the blood pressure
monitor be powered
from an uninterrup-
tible power supply
or a battery.

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NOTE UTis the a.c. mains voltage prior to application of the
test level.
Electromagnetic Immunity
The blood pressure monitor is intended for use in the
electromagnetic environment specified below. The customer
or the user of the blood pressure monitor should assure that
it is used in such an environment.
Power
frequency
(50/60 Hz)
magnetic
field
IEC61000-
4-8
3 A/m 3 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
Immunity
Test
Conducted
RF
IEC 61000-
4-6
Radiated
RF
IEC 61000-
4-3
IEC
60601
test level
3Vrms
150 kHz
to 80 MHz
3 V/m
80MHz to
2.5 Hz
Compliance
Level
3 Vrms
3 V/m
Electromagnetic
Environment
uidance
Portable and mobile
RF communications
equipment should
be used no closer
to any part of the
blood pressure
monitor, 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 80 MHz
to 800 MHz
d = 2.3√ P 800 MHz
to 2.5 Hz
Where P is the
maximum output
power rating of the
transmitter in watts
(W) according to
the transmitter
manufacturer and d
is the

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NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
aField strengths from fixed transmitter, such as base stations
for radio (cellular/cordless) telephones and land mobile radio,
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 blood
pressure monitor is used exceeds the applicable RF
compliance level above, the blood pressure monitor should
be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary,
such as re-orienting or relocating the blood pressure monitor.
bOver the frequency range 150 kHz to 80 MHz, field strengths
should be less then 3 V/m.
recommended
separation distance
in meters (m). Field
strengths from
fixed RF transmit-
ters, as determined
by an electroma-
gnetic site survey,a
should be less than
the compliance
level in each
frequency rangeb.
Interference may
occur in the vicinity
of equipment
marked with the
following symbol:

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Recommended separation distances between portable
and mobile RF communications equipment and the
blood pressure monitor
The blood pressure monitor is intended for use in an electro-
magnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the blood pressure
monitor can help prevent electromagnetic interference
by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters)
and the blood pressure monitor as recommended below,
according to the maximum output power of the communica-
tions equipment.
Rated
maximum
output
power of
transmitter
W
150 kHz
to 80 MHz
d = 1.2 √P
Separation distance according to frequency
of transmitter M
800 kHz
to 2.5 Hz
d = 2.3 √P
80 kHz
to 800 MHz
d = 1.2 √P
0.01
0.1
1
10
100
0.12
0,37
1.2
3.7
12
0.23
0.74
2.3
7.4
23
0.12
0.37
1.2
3.7
12
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 affected by absorption and
reflection from structures, objects and people.
Spengler SAS
ZI La Limoise - Rue Robert Maréchal
36100 ISSOUDUN - FRANCE