Gima 32921 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima
di utilizzare il prodotto.
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer
y entender completamente este manual antes
de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto.
ACHTUNG: Die Bediener müssen vorher dieses
Handbuch gelesen und verstanden haben,
bevor sie das Produkt benutzen.
UWAGA: przed rozpoczęciem użytkowania wyrobu operatorzy muszą
przeczytać podręcznik i upewnić się, iż wszystko to, co jest w nim napisane
jest dla nich jasne i zrozumiałe.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
M32921-M-Rev.4-11.18
SFIGMOMANOMETRO AUTOMATICO SMART
SMART AUTOMATIC BLOOD PRESSURE MONITOR
TENSIOMÈTRE AUTOMATIQUE SMART
TENSIÓMETRO AUTOMATICO SMART
ESFIGMOMANÔMETRO AUTOMÁTICO SMART
SMART AUTOMATISCHES BLUTDRUCKMESSGERÄT
AUTOMATYCZNY SFIGMOMANOMETR SMART
ΑΥΤΌΜΑΤΌ ΣΦΥΓΜΌΜΑΝΌΜΕΤΡΌ SMART
SMART
Manuale d’uso - User manual - Manuel de l’utilisateur - Guía de Uso
Guia para utilização - Gebrauchsanweisung - Instrukcja obsługi
Όδηγίες χρήσης -
32921 / KD-558
PROFESSIONAL MEDICAL PRODUCTS
0197
ANDON HEALTH CO., LTD.
No. 3 JinPing Street, Ya An Road, Nankai District, Tianjin 300190, China
Made in China
Lotus Global Co., Ltd.
1 Four Seasons Terrace West Drayton,
Middlesex, London, UB7 9GG, United Kingdom

22
ENGLISH
IMPORTANT INFORMATION...................................................................................................................23
CONTENTS AND DISPLAY INDICATORS................................................................................23
INTENDED USE.......................................................................................................................................................24
CONTRAINDICATION....................................................................................................................................... 24
PRODUCT DESCRIPTION.......................................................................................................................... 24
SPECIFICATIONS .................................................................................................................................................25
NOTICE.............................................................................................................................................................................25
SETUP AND OPERATING PROCEDURES.............................................................................. 27
1. Battery loading......................................................................................................................................... 27
2. Clock and date adjustment.......................................................................................................27
3. Connecting the cuff to the monitor.................................................................................28
4. Applying the cuff.................................................................................................................................... 28
5. Body posture during measurement................................................................................29
6. Taking your blood pressure reading...............................................................................29
7. Displaying stored results............................................................................................................. 30
8. Deleting measurements from the memory.............................................................32
9. Assessing high blood pressure for adults ..............................................................33
10. Technical alarm description..................................................................................................... 33
11. Troubleshooting 1.................................................................................................................................34
12. Troubleshooting 2 ...............................................................................................................................35
MAINTENANCE.......................................................................................................................................................35
EXPLANATION OF SYMBOLS ON UNIT................................................................................... 36
ELECTROMAGNETIC COMPATIBILITY INFORMATION......................................... 37
INDEX

23 ENGLISH
IMPORTANT INFORMATION
Normal blood pressure fluctuation
All physical activity, excitement, stress, eating, drinking, smoking, body
posture and many other activities or factors (including taking a blood
pressure measurement) will inuence blood pressure value. Because of this,
it is mostly unusual to obtain identical multiple blood pressure readings.
Blood pressure uctuates continually day and night. The highest value
usually appears in the daytime and lowest one usually at midnight. Typically,
the value begins to increase at around 3:00 AM, and reaches to highest level
in the daytime while most people are awake and active.
Considering the above information, it is recommended that you measure
your blood pressure at approximately the same time each day.
Too frequent measurements may cause injury due to blood ow interference,
please always relax a minimum of 1 to 1.5 minutes between measurements
to allow the blood circulation in your arm to recover. It is rare that you obtain
identical blood pressure readings each time.
CONTENTS AND DISPLAY INDICATORS
Ready to initiate indicator
Blood pressure level
Classication indicator
Irregular heartbeat symbol
Memory indicator
Systolic pressure
Diastolic pressure
Pulse rate display
(alternating)
MEM botton
START botton
Low battery indicator
Date/Time display (alternating)
Cuff
LCD Display

24
INTENDED USE
Fully Automatic Electronic Sphygmomanometer is for use by medical
professionals or at home and is a non-invasive blood pressure measurement
system intended to measure the diastolic and systolic blood pressures
and pulse rate of an adult individual by using a non-invasive technique
in which an inatable cuff is wrapped around the upper arm. The cuff
circumference is limited to 22cm-48cm (approx. 8 21/32”~18 29/32”).
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use
this Electronic Sphygmomanometer
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor,
blood pressure and pulse rate can be measured automatically and
non-invasively. The LCD display will show blood pressure and pulse rate.
The most recent 2x60 measurements can be stored in the memory with date
and time stamp. The monitor can also show the average reading of the last
three measurements.The Electronic Sphygmomanometers corresponds
to the below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/
A1:2013 (Medical electrical equipment -- Part 1: General requirements
for basic safety and essential performance), IEC60601-1-2:2007/EN 60601-
1-2:2007 /AC:2010 (Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests),
IEC80601-2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015 (Medical
electrical equipment – Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive sphygmomanometers)
EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers
- Part 1: General requirements), EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements
for electro-mechanical blood pressure measuring systems).
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SPECIFICATIONS
1. Product name: Blood Pressure Monitor
2. Model: KD-558
3. Classication: Internally powered, Type BF applied part, IP20, No AP
or APG, Continuous operation
4. Machine size: Approx. 138mm × 98mm × 48mm
(5 7/16” x 3 27/32” x 1 7/8”)
5. Cuff circumference: 22cm-30cm (8 21/32”-11 13/16”),
30cm-42cm (11 13/16”-16 17/32”) (Optional),
42cm-48cm (16 17/32”-18 29/32”) (Optional)
6. Weight: Approx. 211g (7 7/16 oz.) (exclude batteries and cuff)
7. Measuring method: Oscillometric method, automatic ination
and measurement
8. Memory volume: 2x60 times with time and date stamp
9. Power source: batteries: 4 ×1.5V SIZE AA
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
11. Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
12. Environmental temperature for operation: 10°C~40°C (50°F~104°F)
13. Environmental humidity for operation: ≤90%RH
14. Environmental temperature for storage and transport: -20°C~55°C
(-4°F~131°F)
15. Environmental humidity for storage and transport: ≤90%RH
16. Environmental pressure: 80KPa-105KPa
17. Battery life: Approx 500 times
18. A list of all components belonging to the pressure measuring system,
including accessories: Pump,Valve, LCD, Cuff, Sensor
Note: These specications are subject to change without notice.
Batteries storage tempreture: 20±2°C
Batteries storage humidity: 30~70%RH
NOTICE
1. Read all of the information in the operation guide and any other literature
in the box before operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements
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26
to allow the blood circulation in your arm to recover. Prolonged
over-ination (cuff pressure exceed 300 mmHg or maintained above15
mmHg for longer than 3 minutes) of the bladder may cause ecchymoma
of your arm.
7. Consult your physician if you have any doubt about below cases:
1 The application of the cuff over a wound or inammation diseases;
2 The application of the cuff on any limb where intravascular access
or therapy, or an arterio-venous (A-V) shunt, is present;
3 The application of the cuff on the arm on the side of a mastectomy;
4 Simultaneously used with other monitoring medical equipments
on the same limb;
5 Need to check the blood circulation of the user.
8. This Electronic Sphygmomanometers is designed for adults and
should never be used on infants or young children. Consult your physician
or other health care professionals before use on older children.
9. Do not use this unit in a moving vehicle, This may result in erroneous
measurement.
10.Blood pressure measurements determined by this monitor are equivalent
to those obtained by a trained observer using the cuff/stethoscope
auscultation method, within the limits prescribed by the American
National Standard Institute, Electronic or automated sphygmomanometers.
11.Information regarding potential electromagnetic or other interference
between the blood pressure monitor and other devices together
with advice regarding avoidance of such interference please see part
ELECTROMAGNETIC COMPATIBILITY INFORMATION.
12.If Irregular Heartbeat (IHB) brought by common arrhythmias is detected
in the procedure of blood pressure measurement, a signal of ‘(♥)’will be
displayed. Under this condition, the Electronic Sphygmomanometers
can keep function, but the results may not be accurate, it’s suggested
that you consult with your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be displayed:
1 The coefcient of variation (CV) of pulse period >25%.
2 The difference of adjacent pulse period≥0.14s, and the number of such
pulse takes more than 53 percentage of the total number of pulse.
13.Please do not use the cuff other than supplied by the manufacturer,
otherwise it may bring biocompatible hazard and might result in
measurement error.
14. The monitor might not meet its performance specications or cause
safety hazard if stored or used outside the specied temperature and
humidity ranges in specications.
15. Please do not share the cuff with other infective person to avoid
cross-infection.
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16.This equipment has been tested and found to comply with the limits for
a Class B digital device, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
SETUP AND OPERATING PROCEDURES
1. Battery loading
a. Open battery cover at the back of the monitor.
b. Load four “AA” size batteries. Please pay attention to polarity.
c. Close the battery cover.
When LCD shows battery symbol , replace all batteries with new ones.
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a month or more
to avoid relevant damage of battery leakage.
Avoid the battery uid to get in your eyes. If it should get in your eyes,
immediately rinse with plenty of clean water and contact a physician.
The monitor, the batteries and the cuff, must be disposed of according
to local regulations at the end of their usage.
2. Clock and date adjustment
a. Once you install the battery or turn off the monitor, it will enter Clock
Mode, and LCD will display time and date by turns. See picture 2&2-1.
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Picture 2 Picture 2-1 Picture 2-2
b. While the monitor is in Clock Mode, pressing both the “START” and
“MEM” button simultaneously, a beep is heard and the month will blink
at rst. See picture 2-2. Press the button “START” repeatedly, the day,
hour and minute will blink in turn. While the number is blinking, press
the button “MEM” to increase the number. Keep on pressing the button
“MEM”, the number will increase fast.
c. You can turn off the monitor by pressing “START” button when the minute
is blinking, then the time and date is conrmed.
d. The monitor will turn off automatically after 1 minute of no operation,
with the time and date unchanged.
e. Once you change the batteries, you should readjust the time and date.
3. Connecting the cuff to the monitor
Insert the cuff tubing connector into the socket in the left side of the monitor.
Make certain that the connector is completely inserted to avoid air leakage
during blood pressure measurements.
Avoid compression or restriction of the connection tubing during
measurement which may cause ination error, or harmful injury due to
continuous cuff pressure
4. Applying the cuff
a. Pulling the cuff end through the medal loop
(the cuff is packaged like this already), turn it outward
(away from your body) and tighten it and close the
Velcro fastener.
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b. Place the cuff around a bare arm 1-2cm above
the elbow joint.
c. While seated, place palm upside in front of you on a
at surface such as a desk or table. Position the
air tube in the middle of your arm in line with your
middle nger.
d. The cuff should t comfortably, yet snugly around your arm. You should
be able to insert one nger between your arm and the cuff.
Note:
1. Please refer to the cuff circumference range in “SPECIFICATIONS”
to make sure that the appropriate cuff is used.
2. Measuring on same arm each time.
3. Do not move your arm, body, or the monitor and do not move the rubber
tube during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from
the monitor and clear it by hand in a mild detergent, then rinse
it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it.
Clean the cuff after the usage of every 200 times is recommended.
5. Body posture during measurement
Sitting Comfortably Measurement
a. Be seated with your feet at on the oor,
and don’t cross your legs.
b. Place palm upside in front of you on a at surface
such as a desk or table.
c. The middle of the cuff should be at the level
of the right atrium of the heart.
Lying Down Measurement
a. Lie on your back.
b. Place your arm straight along your side with your
palm upside.
c. The cuff should be placed at the same level
as your heart.
6. Taking your blood pressure reading
a. After applying the cuff and your body is in a comfortable position, press
the “START” button. A beep is heard and all display characters are shown
for self-test. See picture 6. Please contact the service center if segment
is missing.
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b. Then the current memory bank (U1 or U2) is blinking. See picture 6-1.
Press “MEM” button to change over to other bank. See picture 6-2.
Conrm your selection by pressing “START” button. The current bank
can also be conrmed automatically after 5 seconds with no operation.
Picture 6 Picture 6-1 Picture 6-2
c. After selecting the memory bank, the monitor starts to seek zero pressure.
See picture 6-3.
d. The monitor inates the cuff until sufcient pressure has built up for a
measurement. Then the monitor slowly releases air from the cuff and
carries out the measurement. Finally the blood pressure and pulse rate
will be calculated and displayed on the LCD screen separately. Irregular
heartbeat symbol (if any) will blink. See picture 6-4&6-5. The result will
be automatically stored in the current memory bank.
Picture 6-3 Picture 6-4 Picture 6-5
e. After measurement, the monitor will turn off automatically after 1 minute
of no operation. Alternatively, you can press the “START” button to turn off
the monitor manually.
f. During measurement, you can press the “START” button to turn off
the monitor manually.
Note: Please consult a health care professional for interpretation of pressure
measurements.
7. Displaying stored results
a. After the measurement, you can review the measurements in the current
memory bank by pressing button “MEM”. Now the LCD displays the
amount of the results in the current bank. See picture 7.
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Picture 7 Picture 7-1 Picture 7-2
b. Alternatively, press “MEM” button in Clock Mode to display the stored
results. The current memory bank will blink and the amount of results
in this bank will be displayed. See picture 7-1. Press “START” button
to change over to other bank. See picture 7-2. Conrm your selection
by pressing “MEM” button. The current bank can also be conrmed
automatically after 5 seconds with no operation.
c. After selecting the memory bank, the LCD will display the average value
of the last three results in this bank, See picture 7-3 &7-4. If no result
stored, LCD will show dashes as picture 7-5.
Picture 7-3 Picture 7-4 Picture 7-5
d. When the average is displayed, press the “MEM” button, the most recent
result will be displayed. See picture 7-6. Followed by, the blood pressure
and pulse rate will be shown separately. Irregular heartbeat symbol (if any)
will blink. See picture 7-7&7-8. Press “MEM” button again to review
the next result. See picture 7-9. In this way, repeatedly pressing
the “MEM” button displays the respective results measured previously.
Picture 7-6 Picture 7-7
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Picture 7-8 Picture 7-9
e. When displaying the stored results, the monitor will turn off automatically
after 1 minute of no operation. You can also press the button “START”
to turn off the monitor manually.
8. Deleting measurements from the memory
When any result (except average reading of the last three results)
is displaying, keeping on pressing button “MEM” for three seconds,
all results in the current memory bank will be deleted after three “beep”.
LCD will show picture 8, Press the button “MEM” or “START”, the monitor
will turn off.
Picture 8
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9. Assessing high blood pressure for adults
The following guidelines for assessing high blood pressure (without regard
to age or gender) have been established by the World Health Organization
(WHO). Please note that other factors (e.g. diabetes, obesity, smoking, etc.)
need to be taken into consideration. Consult with your physician for accurate
assessment, and never change your treatment by yourself.
10. Technical alarm description
The monitor will show ‘HI’ or ‘Lo’ as technical alarm on LCD with no delay
if the determined blood pressure (systolic or diastolic) is outside the rated
range specied in part SPECIFICATIONS. In this case, you should consult
a physician or check if your operation violated the instructions.
The technical alarm condition (outside the rated range) is preset in the factory
and cannot be adjusted or inactivated. This alarm condition is assigned as
low priority according to IEC 60601-1-8. The technical alarm is non-latching
and need no reset. The signal displayed on LCD will disappear automatically
after about 8 seconds.
SBP
mmHg
<120
120-129
130-139
140-159
160-179
≥180
DBP
mmHg
<80
80-84
85-89
90-99
100-109
≥110
BLOOD PRESSURE
CLASSIFICATION
Optimal
Normal
High-Normal
Grade 1 Hypertension
Grade 2 Hypertension
Grade 3 Hypertension
WHO/ISH Denitions and classication of blood
pressure levels
80 85 90 100 110
120
130
140
150
160 Severe Hypertension
Moderate Hypertension
Mild Hypertension
High-normal BP
Normal BP
Diastolic
(mmHg)
Sistolic
(mmHg)
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LCD Display
shows
abnormal
result
The cuff position was not
correct or it was not properly
tightened
Body posture was not correct
during testing
Speaking, arm or body
movement, angry, excited
or nervous during testing
Irregular heartbeat (arrhythmia)
Apply the cuff correctly and try
again
Review the “BODY POSTURE
DURING MEASUREMENT”
sections of the instructions
and re-test
Re-test when calm and without
speaking or moving during the test
It is inappropriate for people
with serious arrhythmia to use this
Electronic Sphygmomanometer
11. Troubleshooting 1
PROBLEM POSSIBLE CAUSE SOLUTION
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12. Troubleshooting 2
PROBLEM POSSIBLE CAUSE SOLUTION
MAINTENANCE
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and solarization. Do not immerse the monitor
in water as this will result in damage to the monitor.
3. If this monitor is stored near freezing, allow it to acclimate to room
temperature before use.
4. Do not attempt to disassemble this monitor.
LCD shows low
battery symbol
LCD shows “Er 0”
LCD shows “Er 1”
LCD shows “Er 2”
LCD shows “Er 3”
LCD shows “Er 4”
LCD shows “Er 5”
LCD shows “Er 6”
LCD shows “Er 7”
LCD shows “Er 8”
LCD shows “Er A”
No response when
you press button
or load battery
Low Battery
Pressure system is unstable
before measurement
Fail to detect systolic pressure
Fail to detect diastolic pressure
Pneumatic system blocked or
cuff is too tight during ination
Pneumatic system leakage or
cuff is too loose during ination
Cuff pressure above 300mmHg
More than 3 minutes with cuff
pressure above 15 mmHg
EEPROM accessing error
Device parameter checking
error
Pressure sensor parameter
error
Incorrect operation or strong
electromagnetic interference
Change the batteries
Don’t move and try again
Apply the cuff correctly
and try again
Measure again after ve
minutes. If the monitor is still
abnormal, please contact
the local distributor or the
factory
Take out batteries for ve
minutes, and then reinstall
all batteries
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5. If you do not use the monitor for a long time, please remove the batteries.
6. It is recommended the performance should be checked every 2 years
or after repair. Please contact the service center.
7. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after
moistened with water, diluted disinfectant alcohol, or diluted detergent.
8. No component can be maintained by user in the monitor. The circuit
diagrams, component part lists, descriptions, calibration instructions,
or other information which will assist the user’s appropriately qualied
technical personnel to repair those parts of equipment which
are designated repairably can be supplied.
9. The monitor can maintain the safety and performance characteristics
for a minimum of 10,000 measurements or three years, and the cuff can
maintain the performance characteristics for a minimum of 1000
measurements.
10.It is recommended the cuff should be disinfected 2 times every week
if needed (For example, in hospital or in clinique). Wipe the inner side
(the side contacts skin) of the cuff by a soft cloth squeezed after
moistened with Ethyl alcohol (75-90%), then dry the cuff by airing.
EXPLANATION OF SYMBOLS ON UNIT
Symbol for” THE OPERATION GUIDE MUST BE READ”
(The sign background colour: blue.The sign graphical symbol: white).
Symbol for “WARNING”.
Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part).
Symbol for “ENVIRONMENT PROTECTION - Waste electrical products
should not be disposed of with household waste. Please recycle
where facilities exist. Check with your local Authority or retailer
for recycling advice”.
Symbol for “MANUFACTURER”.
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”.
Symbol for “DATE OF MANUFACTURE”.
Symbol for “EUROPEAN REPRESENTATIVE”.
SN Symbol for “SERIAL NUMBER”.
Symbol for “KEEP DRY”.
Symbol for “KEEP AWAY FROM SUNLIGHT”.
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0197
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Symbol for “ PRODUCT CODE ”.
Symbol for “ LOT NUMBER ”.
ELECTROMAGNETIC COMPATIBILITY
INFORMATION
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The [KD-558] is intended for use in the electromagnetic environment specied below.
The customer or the user of the [KD-558] should assure that it is used in such
an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
The [KD-558] 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
The [KD-558] 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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Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The [KD-558] is intended for use in the electromagnetic environment specied below.
The customer or the user of the [KD-558] should assure that it is used in such
an environment.
IMMUNITY test IEC 60601 Compliance Electromagnetic
test level level environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
± 6 kV
contact
± 8 kV air
3 A/m
Floors should be wood,
concrete or ceramic tile. If oors
are covered with synthetic
material, the relative humidity
should be at least 30%
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment
± 6 kV
contact
± 8 kV air
3 A/m
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Table 3
For ME EQUIPMENT and ME SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The [KD-558] is intended for use in the electromagnetic environment specied below.
The customer or the user of the [KD-558] should assure that it is used in such
an environment.
IMMUNITY test IEC 60601 Compliance Electromagnetic environment -
test level level guidance
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 reection from structures, objects and people.
aField strengths from xed 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 xed RF transmitters, an electromagnetic site
Radiated RF
IEC 61000-4-3 3 V/m 80 MHz to
2.5 GHz
Portable and mobile RF
communications equipment should
be used no closer to any part of the
[KD-558], including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency
of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Where Pis the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and dis the
recommended separation distance
in meters (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,ashould
be less than the compliance level
in each frequency range.b
Interference may occur in the vicinity
of equipment marked with
the following symbol:
3 V/m
ENGLISH

40
survey should be considered. If the measured eld strength in the location in which
the [KD-558] is used exceeds the applicable RF compliance level above, the [KD-558]
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the [KD-558].
bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than
3V/m.
Table 4
For ME EQUIPMENT and ME SYSTEMS that are not
LIFE-SUPPORTING
Recommended separation distances between portable
and mobile RF communications equipment and the [KD-558]
The [KD-558] is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the [KD-558] can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the [KD-558]
as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power
of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
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 determined 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 reection from structures, objects and people.
ENGLISH