Gima KD-558 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
M32921-M-Rev.5-02.21
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
32921 / KD-558
0197
ANDON HEALTH CO., LTD.
No. 3 JinPing Street, Ya An Road,
Nankai District, Tianjin 300190, China
Made in China
iHealthLabs Europe SAS
36 Rue de Ponthieu,
75008, Paris, France
PROFESSIONAL MEDICAL PRODUCTS

20
ENGLISH
IMPORTANT INFORMATION................................................................. 21
CONTENTS AND DISPLAY INDICATORS............................................. 21
INTENDED USE..................................................................................... 22
CONTRAINDICATION............................................................................ 22
PACKAGE CONTENTS ......................................................................... 22
PRODUCT DESCRIPTION .................................................................... 22
SPECIFICATIONS.................................................................................. 23
NOTICE.................................................................................................. 23
SETUP AND OPERATING PROCEDURES........................................... 26
1. Battery loading............................................................................... 26
2. Clock and date adjustment............................................................ 26
3. Connecting the cuff to the monitor................................................. 27
4. Applying the cuff............................................................................ 27
5. Body posture during measurement ............................................... 28
6. Taking your blood pressure reading .............................................. 28
7. Displaying stored results ............................................................... 29
8. Deleting measurements from the memory .................................... 31
9. Assessing high blood pressure for adults...................................... 31
10. Technical alarm description ........................................................... 32
11. Troubleshooting 1.......................................................................... 32
12. Troubleshooting 2 ......................................................................... 33
MAINTENANCE ..................................................................................... 33
EXPLANATION OF SYMBOLS ON UNIT .............................................. 35
ELECTROMAGNETIC COMPATIBILITY INFORMATION...................... 36
INDEX

21 ENGLISH
IMPORTANT INFORMATION
Normal blood pressure uctuation
All physical activity, excitement, stress, eating, drinking, smoking, body posture
and many other activities or factors (including taking a blood pressure meas-
urement) will inuence blood pressure value. Because of this, it is mostly unu-
sual 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 day-
time 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

22
INTENDED USE
Fully Automatic Electronic Sphygmomanometer is for use by medical profes-
sionals 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
PACKAGE CONTENTS
1 Blood Pressure Monitor
1 Operation Guide
1 Arm Cuff
1 Soft Storage Case
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor,
blood pressure and pulse rate can be measured automatically and non-inva-
sively. 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), IEC60601-1-2:2014/EN 60601-1-
2:2015 (Medical electrical equipment -- Part 1-2: General requirements for ba-
sic 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: Particu-
lar 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 measur-
ing systems). ISO81060-2 :2013(Non-Invasive Sphygmomanometers - Part 2:
Clinical Validation Of Automated Measurement Type)
ENGLISH

23
SPECIFICATIONS
1. Product name: Arm 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 measure-
ment
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%
Precision of the displayed values:1mmHg
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, in-
cluding 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.
ENGLISH

24
5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements
to allow the blood circulation in your arm to recover. Prolonged over-ina-
tion (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 or
lymph node clearance;
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 meas-
urement.
10. Blood pressure measurements determined by this monitor are equivalent to
those obtained by a trained observer using the cuff/stethoscope ausculta-
tion method, within the limits prescribed by the American National Standard
Institute, Electronic or automated sphygmomanometers.
11. Information regarding potential electromagnetic or other interference be-
tween the blood pressure monitor and other devices together with advice
regarding avoidance of such interference please see part ELECTROMAG-
NETIC 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, other-
wise 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 hu-
midity ranges in specications.
ENGLISH

25
15. Please do not share the cuff with other infective person to avoid cross-in-
fection.
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 particu-
lar 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.
17. Attention that changes or modication not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
18. Measurements are not possible in patients with a high frequency of arrhyth-
mias.
19. The device is not intended for use on neonates, children or pregnant wom-
en. (Clinical testing has not been conducted on neonates, children or preg-
nant women.)
20. Motion, trembling, shivering may affect the measurement reading.
21. The device would not apply to the patients with poor peripheral circulation,
noticeably low blood pressure, or low body temperature (there will be low
blood ow to the measurement position).
22. The device would not apply to the patients who use an articial heart and
lung (there will be no pulse)
23. Consult your physician before using the device for any of the following con-
ditions: common arrhythmias such as atrial or ventricular premature beats
or atrial brillation, arterial sclerosis, poor perfusion, diabetes, pre-eclamp-
sia, enal diseases.
24. The patient can be an intended operator.
25. Swallowing batteries and/or battery uid can be extremely dangerous. Keep
the batteries and the unit out of the reach of children and disabled persons.
26 If you are allergic to plastic/rubber, please don’t use this device.
ENGLISH

26
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, im-
mediately rinse with plenty of clean water and contact a physician.
The negative terminal of the battery needs to be compressed into the bat-
tery compartment properly after horizontal compression of the negative
electrode. The battery is in contact with the spring.
Make sure the battery cover is intact and not damaged before installing
the battery.
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.
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.
ENGLISH

27
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 dur-
ing blood pressure measurements.
Avoid compression or restriction of the connection tubing during measure-
ment 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.
b. Place the cuff around a bare arm 1-2cm above the
elbow joint.
c. If you place the cuff around left arm,position the air
tube in the middle of your arm in line with your mid-
dle nger.
If you place the cuff around right arm, apply the cuff
so that the air tube is at the side of your elbow.
d. 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.
e. The cuff should t comfortably, yet snugly around
your arm. You should be able to insert one nger
between your arm and the cuff.
ENGLISH

28
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 mon-
itor 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.
6. Do not place the cuff around your arm if the arm has any inammation, acute
diseases, infections skin wounds.
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 miss-
ing.
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.
ENGLISH

29
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 meas-
urement. Then the monitor slowly releases air from the cuff and carries out
the measurement. Finally the blood pressure and pulse rate will be calculat-
ed 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 mon-
itor 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.
ENGLISH

30
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
ENGLISH

31
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
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.
ENGLISH

32
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 physi-
cian or check if your operation violated the instructions.
The technical alarm condition (outside the rated range) is present 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.
11. Troubleshooting 1
ENGLISH
PROBLEM POSSIBLE CAUSE SOLUTION
LCD Display
shows abnormal
result
The cuff position was not correct
or it was not properly tightened Apply the cuff correctly and try again
Body posture was not correct dur-
ing testing
Review the “BODY POSTURE
DURING MEASUREMENT” sec-
tions of the instructions and re-test
Speaking, arm or body move-
ment, angry, excited or nervous
during testing
Re-test when calm and without
speaking or moving during the test
Irregular heartbeat (arrhythmia) It is inappropriate for people with serious arrhythmia to use this
Electronic Sphygmomanometer
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)

33
12. Troubleshooting 2
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 tempera-
ture before use.
4. Do not attempt to disassemble this monitor.
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 dia-
grams, component part lists, descriptions, calibration instructions, or other
information which will assist the user’s appropriately qualied technical per-
sonnel to repair those parts of equipment which are designated repairably
can be supplied.
ENGLISH
PROBLEM POSSIBLE CAUSE SOLUTION
LCD shows low battery
symbol Low Battery Change the batteries
LCD shows “Er 0” Pressure system is unstable
before measurement Don’t move and try again
LCD shows “Er 1” Fail to detect systolic pressure
LCD shows “Er 2” Fail to detect diastolic pressure
LCD shows “Er 3” Pneumatic system blocked or
cuff is too tight during ination Apply the cuff correctly
and try again
LCD shows “Er 4” Pneumatic system leakage or
cuff is too loose during ination
LCD shows “Er 5” Cuff pressure above 300mmHg
Measure again after ve
minutes. If the monitor
is still abnormal, please
contact the local distribu-
tor or the factory
LCD shows “Er 6” More than 3 minutes with cuff
pressure above 15 mmHg
LCD shows “Er 7” EEPROM accessing error
LCD shows “Er 8” Device parameter checking error
LCD shows “Er A” Pressure sensor parameter error
No response when you
press button or load
battery
Incorrect operation or strong
electromagnetic interference
Take out batteries for
ve minutes, and then
reinstall all batteries

34
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.
11. The monitor requires 6 hours to warm from the minimum storage tempera-
ture between uses until the monitor is ready for its INTENDED USE when
the ambient temperature is 20°C.
12. The monitor requires 6 hours to cool from the maximum storage tempera-
ture between uses until the monitor is ready for its INTENDED USE when
the ambient temperature is 20°C.
13. No servicing/maintenance while the monitor is in use.
ENGLISH

35 ENGLISH
Product code
Lot number
Keep in a cool, dry place
Keep away from sunlight
Manufacturer
Date of manufacture
Medical Device complies with Directive 93/42/EEC
Caution: read instructions (warnings) carefully
WEEE disposal
Follow instructions for use
Authorized representative in the European community
Serial number
Type BF applied part
IP20 Covering Protection rate
EXPLANATION OF SYMBOLS ON UNIT

36
ENGLISH
ELECTROMAGNETIC COMPATIBILITY
INFORMATION
Table 1
Emission
Table 2
Enclosure Port
Phenomenon Compliance Electromagnetic environment
RF emissions CISPR 11
Group 1,
Class B
Home healthcare environment
Harmonic distortion IEC 61000-3-2
Class A Home healthcare environment
Voltage uctuations and icker IEC 61000-3-3
Compliance Home healthcare environment
Phenomenon Basic EMC standard Immunity test levels
Home Healthcare Environment
Electrostatic
Discharge IEC 61000-4-2 ±8 kV contact ±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM eld IEC 61000-4-3 10V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity elds from RF
wireless communications
equipment
IEC 61000-4-3 Refer to table 3
Rated power frequency
magnetic elds IEC 61000-4-8 30A/m 50Hz or 60Hz

37
Table 3
Proximity elds from RF wireless communications equipment
ENGLISH
Disposal: The product must not be disposed of along with other do-
mestic waste. The users must dispose of this equipment by bringing
it to a specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Test frequency
(MHz) Band (MHz) IMMUNITY TEST LEVEL (V/m)
Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m
710
704-787
Pulse modulation 217Hz, 9V/m
745
780
810
800-960
Pulse modulation 18Hz, 28V/m
870
930
1720
1700-1990
Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240
5100-5800
Pulse modulation 217Hz, 9V/m
5500
5785