blood pressure measuring system

Operating instructions
BLOOD PRESSURE MEASURING SYSTEM
BLOOD PRESSURE MEASURING SYSTEM
www.imetec.com
Tenacta Group S.p.A. Via Piemonte 5/11
24052 Azzano S. Paolo (BG) ITALY
Tel. +39.035.688.111 Fax +39.035.320.149
TYPE KD-5031
ENpage1
[A]
ILLUSTRATIVE GUIDE
TECHNICAL DATA
1
2
3
4
9
8
5
6
1.1
7
1.2
1.9
1.3
1.8
2013
1.4
2013
1.5
1.7
I
1.6
II
III
EN
Blood
pressure
measuring
system instructions for USE
Dear customer, IMETEC thanks you for having purchased this
product. We are certain you will appreciate the quality and reliability
of this appliance, designed and manufactured with customer
satisfaction in mind. These instructions for use have been drawn
up in accordance with European Standard EN 62079.
IMPORTANT INSTRUCTIONS
FUTURE USE
KEEP
ATTENTION!
Instructions
warnings for a safe use.
FOR
and
Before using this appliance, carefully read
the instructions and in particular the safety
warnings, which must be complied with.
Keep this manual and illustrative guide
with the appliance for future consultation.
Should you pass the appliance on to
another user, make sure to also include
this documentation.
Should certain parts of this booklet be
difficult to understand or should doubts
arise, contact the company before using
the product, at the address indicated on
the last page.
1
EN
INDEX
SAFETY NOTES
Page 2
CONTRAINDICATIONS Page 5
SYMBOLS
Page 6
DESCRIPTION OF THE APPLIANCE
Page 7
INTENDED USE Page 7
FLUCTUATIONS IN BLOOD PRESSURE
Page 8
HYPERTENSION IN ADULTS
Page 8
USAGE RECOMMENDATIONS
Page 9
USE Page 10
Installing the batteries
Page 11
Date and time setting
Page 11
Cuff application and posture Page 12
Applying the cuff and body posture
during measurement
Page 13
Pressure readings Page 14
Recalling memorised readings
Page 16
Deleting previous readings from the memory
Page 16
CLEANING AND MAINTENANCE
Page 17
STORING AND CARING FOR THE PRODUCT
Page 17
TROUBLESHOOTING Page 18
DISPOSAL
Page 20
DISPOSING OF THE BATTERIES
Page 20
ASSISTANCE AND WARRANTY
Page 20
TECHNICAL DATA
Page 21
STANDARDS
Tab. III Page 22
INFORMATIONS ON ELECTROMAGNETIC
COMPATIBILITY
Page 22
Illustrative guide
Tab. I-II
•
2
SAFETY NOTES
After having removed the appliance from its packaging,
verify its integrity based on the drawing and any presence
of damage caused by transport. If in doubt, do not use
the appliance and contact an authorised service centre.
•
•
•
EN
Do not let children play with the packaging! Keep
the plastic bag out of the reach of children - risk of
suffocation!
This appliance must only be used for the purpose it was
designed for, that is as an automatic blood pressure
monitor for home use. Any other use is considered not
compliant and therefore dangerous.
The device should not be used by people (including
children) with reduced physical, sensorial or mental
capabilities or lack of experience and knowledge, unless
aided or instructed by another person responsible for
their safety.
Children must be supervised to ensure they do not
play with the appliance. In order to prevent accidental
strangulation, keep the appliance away from the reach
of children and avoid wrapping the cuff and/or the tube
around the neck.
WARNING - The appliance is not suitable for
measuring the blood pressure of patients under
the age of 12.
•
•
•
•
If the appliance is faulty or malfunctions, switch it off and
do not tamper with it. Any repairs must only be carried
out by an authorised technical service centre.
Inspect the appliance frequently to check for signs of
wear and tear. If such signs are found or if the appliance
has been used incorrectly, contact an authorised
technical assistance centre before continuing to use it.
Remove the batteries from the appliance if you do not
intend to use it for a long period of time.
Replace the batteries if the appliance has not been
used for over a month to prevent damaging the battery
compartment.
3
EN
•
•
•
•
•
•
4
Use only the supplied accessories.
Do not share the appliance with persons who have
infectious diseases, so as to prevent risk of infection.
Do not use the appliance near strong electric fields
such as mobile phones, microwaves, sources of X-rays,
etc.
Information on potential risks of electromagnetic
interference between the appliance and other devices
that can be affected by such interference is found in the
"Information on electromagnetic compatibility" section.
The appliance complies with the requisites for class B
electromedical devices, corresponding to part 15 of the
FCC rules.
These limits are designed to provide reasonable
protection against dangerous interference when used at
home. This appliance generates, uses and can radiate
radio frequency energy and, if not installed and used
in accordance with the instructions, can interfere with
radio communications.
However, there is no guarantee that there will not be
interference in a particular installation.
If the appliance causes harmful interference to radio
or television reception, which can be determined by
turning the appliance on and off, the user must:
• redirect or relocate the receiving antenna;
• increase the separation between the appliance and
receiver;
• connect the appliance into a socket on a circuit
different from that to which the receiver is connected;
• consult the dealer or an experienced radio/TV
technician for help.
EN
CONTRAINDICATIONS
Attention: do not use the appliance in an area
concerning CAT radiation, X-rays, magnetic
resonance imaging (MRI) and in case of wounds
or injuries to the arm.
Warning: do not use the appliance on persons
undergoing dialysis or taking anticoagulants, antiplatelet
drugs or steroids for risk of internal haemorrhage,
without having first consulted a doctor.
Always consult your doctor regarding the results given
by the appliance in the following cases:
• common arrhythmia;
• premature ventricular or atrial beats;
• atrial fibrillation;
• diabetes;
• circulatory problems;
• kidney problems;
• persons who have had a stroke and are unconscious;
• persons with general arteriosclerosis, with muscle
spasms in the upper limbs;
• persons with pacemakers;
• pregnant women.
5
EN
SYMBOLS
Keep away from humidity
Read the instructions
Warning
Prohibited
The device must be disposed of in accordance
with the provisions of European standard
2002/96/EC
Type BF applied part. The cuff is a type BF
applied part
Manufacturer
Compliance with the Medical Directive 93/42/EC
for medical devices
Date of production
European representative
Irregular heart beat indicator
Flat battery indicator
Unstable or excessive cuff pressure indicator
Inflation error indicator
6
EN
DESCRIPTION OF THE APPLIANCE (Fig. A)
1. LCD display
1.1 Date and time
1.2 Systolic blood pressure
1.3 Diastolic blood pressure
1.4 Heart beat frequency
1.5 Irregular heart beat indicator
1.6 Flat battery indicator
1.7 Memory position
1.8 Unstable or excessive cuff pressure indicator
1.9 Inflation error indicator
2. Classification of the pressure values based on WHO
indications
3. Risk indicator
4. "START" button
5. "MEM" Memory button
6. Cuff
7. Tube for connecting the cuff to the appliance
8. Connector for connecting the tube to the appliance
9. Battery compartment
INTENDED USE
The automatic blood pressure measuring system is specific for
measuring blood pressure and heart beat frequency in adults.
TECHNICAL ALARM
The display shows the 'Hi' or 'Lo' technical alarm if the blood
pressure measured (systolic or diastolic) is beyond the blood
pressure measurement range specified in the SPECIFICATIONS
section. In this case, repeat the measurement and if the condition
persists, consult a doctor. The 'Hi' or 'Lo' technical alarm is pre-set
during production and cannot be adjusted or disabled by the user.
This alarm condition is assigned with low priority according to IEC
standard 60601-1-8. The technical alarm is not stored and does
not need to be reset.
7
EN
The signal on the LCD display disappears automatically after
about 8 seconds.
FLUCTUATIONS
IN BLOOD PRESSURE
All physical activities, agitation, stress, eating, drinking, smoking,
body posture and many more (including the blood pressure
measurement itself), affect the pressure values. For these reasons,
it is basically impossible to have identical values when several
measurements are taken.
Blood pressure fluctuations occur continuously during the day and
night.
Normally, the values are higher during the day and lower during
the night. The pressure values normally start to rise at around 3
a.m. and reach maximum level during the day in the waking and
activity hours.
For this reason, it is advised to measure the pressure at around the
same time every day.
HYPERTENSION IN ADULTS
The prescriptions for hypertension in adults are established by
WHO, the World Health Organisation.
Hypertension is the persistent increase in the maximum or
minimum pressure or both, above the normal values (140/90
mmHg).
Some predisposing factors like diabetes, obesity, smoking and old
age can contribute to the development of hypertension.
Arterial hypertension is defined "essential" in 90% of cases and
"secondary" in 10% of cases, when it is a consequence of chronic
kidney diseases or endocrine diseases.
It is asymptomatic and does not cause any significant disturbance
but in time, it damages the blood vessels and the vital organs
(heart, brain, kidney) with serious health consequences.
8
EN
For this reason, in the last few years, the medical class has raised
public awareness on the importance of self-monitoring.
The Imetec KD-5031 blood pressure monitor displays the
classification of the pressure values based on the World Health
Organisation indications. This classification is purely indicative
and aims to highlight any risk situations to be immediately reported
to your doctor, who will indicate specialised in-depth examinations
to be carried out and the relative cure.
Consult your doctor for all necessary in-depth examinations/
clarifications and never modify the treatment prescribed by the
doctor himself.
Reported below is the classification of the pressure values based
on the World Health Organisation indications.
Classification of
the blood pressure
values
•
•
•
Maximum pressure
(systolic)
Minimum pressure
(diastolic)
Indicator bar
colour
Excellent
<120
<80
Green
Normale
120 - 129
80 - 84
Green
Normal - High
130 - 139
85 - 89
Green
1st Degree
hypertension Slight
140 - 159
90 - 99
Yellow
2nd Degree
hypertension Moderate
160 - 179
100 - 109
Orange
3rd Degree
hypertension Serious
>= 180
>= 110
Red
USAGE RECOMMENDATIONS
Relax and lie down for about 5 minutes before taking the
measurement.
Sit comfortably or lie down.
Wear the cuff (6).
9
EN
•
•
•
Always take the measurement on the same arm, preferably
the left.
Do not talk or move while taking the measurement.
Do not take the pressure reading immediately after meals,
especially heavy meals. Wait at least one hour after meals.
Do not smoke or drink alcohol before measuring blood
pressure.
When measuring blood pressure you must not be physically
tired or fatigued.
Measure the pressure at normal body temperature. If you feel
cold or hot, wait a short while before taking the measurement.
Warning: in the event of repeated measurements,
remove the cuff and relax for a few minutes
between one measurement and another, for the
blood circulation to flow correctly in the arm.
Prolonged pressure of the cuff (cuff pressure exceeding
300 mmHg or maintained for more than 3 minutes above
15 mmHg), can cause the arm to bruise.
Warning: a signal will be displayed should
the appliance detect an irregular heart beat
related to common arrhythmia while measuring
the pressure. However, the reading may not
be accurate, therefore, you should always consult your
doctor for a more thorough and specific check-up.
USE
To guarantee the perfect efficiency of the
appliance, it must be used and stored at the
temperature and humidity conditions specified
in the relative section.
10
EN
1. INSTALLING THE BATTERIES
• Open the lid of the battery compartment (9) located behind
the monitor.
• Insert four 1.5 V AA batteries. Pay attention to the polarity.
• Close the lid located behind the monitor (9) by inserting it in its
slot and pressing lightly.
Attention:
•
•
When the display (1) shows the battery symbol (1.6),
replace them with new ones.
do not use rechargeable batteries.
Remove the batteries from the appliance if you do not
intend to use it for a long period of time. Replace the
batteries if the appliance has not been used for over a
month to prevent damaging the battery compartment.
2. DATE AND TIME SETTING
The date and time can be set in "Date and time" mode.
The appliance is in "Date and time" mode when it is off or after
having replaced the batteries.
Date and time
Month
Day
11
EN
•
•
•
•
•
•
•
•
•
•
•
•
•
Press the "START" (4) and "MEM" (5) buttons simultaneously.
The month (1.1) will start flashing first.
Set the month by pressing the ''MEM'' (5) button until the
desired value is reached. To proceed more quickly, keep the
"MEM" (5) button pressed.
Press the "START" (4) button to confirm the month.
After having set the month, the day (1.1) will flash.
Set the day by pressing the "MEM" (5) button until the desired
value is reached. To proceed more quickly, keep the "MEM"
(5) button pressed.
Press the "START" button (4) to confirm the day.
After having set the day, the hour (1.1) will flash.
Set the hour by pressing the "MEM" (5) button until the desired
value is reached. To proceed more quickly, keep the "MEM"
(5) button pressed.
Press the "START" button (4) to confirm the hour.
After having set the hour, the minutes (1.1) will flash.
Set the minutes by pressing the "MEM" (5) button until the
desired value is reached. To proceed more quickly, keep the
"MEM" (5) button pressed.
Press the "START" button (4) to confirm the minutes.
use.
The date and time do not have to be reset after every
The date and time must be reset each time the batteries are
changed.
3. CONNECTING THE CUFF TO THE MONITOR
•
•
•
12
Insert the tube connector in the socket of the appliance (8) on
the left side of the monitor.
Insert it completely.
Ensure that the connector (8) is properly inserted to avoid air
leaks while taking the measurement.
4. CUFF APPLICATION AND POSTURE DURING
MEASUREMENT
EN
Attention:
•
•
do not use the cuff on inflamed skin or with chronic
or infectious skin diseases.
Refer to the indications in the "SPECIFICATIONS"
section to be sure the cuff size is appropriate.
it is preferable to take the measurement on the left
arm.
•
Detach the Velcro and widen the cuff (6)
by pulling the metal ring.
• Wear the cuff on the left forearm at the
same level as the heart, about 2 cm
above the elbow.
Measurement can be taken either lying down or seated:
• Measurement while sitting: sit with your elbow rested on
a flat surface with the back of your hand in contact with the
surface itself.
• Measurement while lying down: lie in a supine position (on
your back) and extend your arm along your body with the palm
of your hand facing upwards.
In both cases:
• Position the connecting tube of the cuff to the appliance (7) in
line with the middle finger.
• Verify that the cuff is not twisted.
• Fasten the cuff (6) to the forearm, tightening it but leaving
sufficient space for a finger to be placed between the cuff and
your arm.
• Close the cuff (6) by joining the strip of Velcro.
13
EN
5. PRESSURE READINGS
•
After having worn the cuff (6) and being in a comfortable
and correct position for the reading, press the "START" (4)
button. An acoustic signal is heard and
the display (1) shows all the elements of
the self-test performed a few moments
before the measurement.
Contact an assistance centre if any part
of the display is missing.
•
After the self-test, the display (1) shows
a "0", then displays the last value saved
in the memory.
•
If there is no saved result in the memory,
the display (1) will show "0" for both the
blood pressure and the heart beat.
The appliance introduces air inside
the cuff (6) until sufficient pressure for
measuring is obtained, then starts to
release the air and proceeds with the
reading.
•
14
EN
•
The blood pressure and the pulses are
measured and shown on the display (1).
•
The measurement result is automatically saved in the memory.
•
After the measurement, the appliance switches off:
•
•
•
automatically after one minute of inactivity;
manually, by pressing the "START" (4) button for a
moment.
The appliance is manually switched off during measurement
by pressing the "START" (4) button.
Warning: in the event that
•
an irregular heart beat is detected and signalled by
•
irregular pressure values are detected and signalled
by the risk indicator symbol (3)
the
symbol (1.5)
repeat the measurement. If the problem persists, consult
a doctor.
15
EN
6. RECALLING MEMORISED READINGS
•
•
•
•
•
Press the "MEM" (5) button to view the
results saved in the memory. The display
(1) will show the assigned memory
position (1.7) and related values with the
date and time: systolic pressure (1.2),
diastolic pressure (1.3), heart beat (1.4),
and classification of the pressure values
according to the WHO indications (2+3).
Press the ‘MEM’ (5) button to scroll all
the results saved in the memory.
If there are no saved results, the display (1) will show "0" for
systolic pressure (1.2), diastolic pressure (1.3) and heart beat
(1.4).
After having displayed the readings saved in the memory,
the appliance automatically switches off after two minutes of
inactivity.
It is possible to manually switch the appliance off when using
the memory function by pressing the "START" (4) button.
7. DELETING PREVIOUS READINGS FROM THE MEMORY
To delete the results of previous readings
saved in the memory:
•
•
•
16
Activate the memory function by pressing
the "MEM" (5) button.
Press the ‘MEM’ button (5) for 3 seconds:
the memory will be cleared of all data
and the display (1) will show dashes.
Press the "MEM" (5) or "START" (4)
button to switch-off the appliance.
EN
CLEANING AND MAINTENANCE
Cleaning the display (1): use a soft, dry cloth. Do not use abrasive
or alcohol based detergents that can damage the surface.
Cleaning the cuff (6): it is recommended to clean the cuff after
about 200 uses or if it becomes dirty.
Remove the cuff (6) from the appliance and use cold water and
a mild detergent to clean it. Do not wash the cuff in the washing
machine and do not dry it with an iron or a tumble dryer.
STORING AND CARING FOR THE
PRODUCT
The appliance maintains its safety and efficiency features for at
least 10,000 measurements or three years.
Do not drop or bang the appliance.
Avoid high temperatures and exposure to direct sunlight.
Never immerse the appliance in water or liquids as this will
damage it.
If the appliance is stored at temperatures close to 0°, keep
it at room temperature until it has stabilised before taking a
measurement.
Do not dismantle the appliance.
If the appliance is not used for a long time, remove the batteries
and replace them.
It is necessary to verify appliance performance every 2 years
or after a repair. Contact the nearest authorised assistance
centre.
17
EN
Warning: in the event of a fault, contact the nearest authorised
assistance centre.
TROUBLESHOOTING
This chapter describes the most common problems related to
appliance use.
If the problems cannot be solved with the information below,
please contact the Authorised Assistance Centre.
PROBLEM
The display shows
anomalous results
18
POSSIBLE CAUSE
The cuff position is
incorrect or it is fastened
incorrectly
SOLUTION
Apply the cuff correctly and
try again
Your body posture
during measurement is
not correct
See the instructions in the
relative section and try again
You were talking, you
moved your body or arm,
you were angry, excited
or nervous while taking
the measurement
Calm down and try again
without talking or moving
Irregular heart beat
(arrhythmia)
The use of the instrument
is inappropriate for persons
with chronic arrhythmia.
Otherwise, consult your
doctor immediately
EN
PROBLEM: the display
shows
The "flat battery" symbol
‘Er 0’
‘Er 1’
‘Er 2’
‘Er 3’
‘Er 4’
‘Er 5’
‘Er 6’
‘Er 7’
‘Er 8’
‘Er 9’
‘Er A’
No response when the
buttons are pressed or
after inserting the batteries
POSSIBLE CAUSE
Flat batteries
The internal pressure of
the appliance is unstable
before the measurement
is taken
Error in measuring the
systolic pressure
Error in measuring the
diastolic pressure
Pneumatic system
blocked or cuff is too tight
during air introduction
Air leak in the pneumatic
system or large cuff
Cuff pressure above 300
mmHg
Cuff pressure above 15
mmHg for more than 3
minutes
Memory error
Device parameters in
error
Microcontroller error
SOLUTION
Change the batteries
Do not move
and repeat the
measurement
Apply the cuff
correctly and repeat
the measurement
Repeat the
measurement after 5
minutes. If the error
persists, contact the
nearest assistance
centre.
Error of the pressure
sensor
Faulty appliance or
strong electromagnetic
interference
Remove the batteries,
wait 5 minutes and
put them back in
Unstable or excessive
pressure in the cuff
The appliance repeats
the measurement
Inflation error
The appliance repeats
the measurement
19
EN
DISPOSAL
The product is packaged in recyclable materials. Dispose
of it in compliance with the environmental protection
standards.
The appliance must be disposed of in compliance with EU
standard 2002/96/EC. The recyclable materials contained
in the appliance must be collected to prevent environmental
pollution. For further information, contact the local waste
authority or the appliance retailer.
DISPOSING OF THE BATTERIES
Warning: Do not dispose of the batteries
in domestic waste: they must be disposed of
separately.
Remove the batteries from the appliance.
Dispose of the batteries at a specific collection centre.
ASSISTANCE AND WARRANTY
To request repairs or purchase spare parts, please contact
IMETEC’s authorised customer service centre at the Toll-Free
Number below or via the website. The appliance is covered by the
manufacturer warranty.
For details, read the attached warranty sheet. Failure to comply
with the instructions for use and maintenance provided in this
manual will render the manufacturer warranty null and void.
20
EN
TECHNICAL DATA
1. Product name: automatic blood pressure measuring system
2. Model: KD-5031
3. Classification: Internal energy, class BF, IPX0, No AP or APG
applied part, Continuous operating mode
4. Appliance dimensions: 165mm x 96mm x 65mm
5. Cuff circumference dimensions: 22cm ~ 30cm
6. Weight: about 300g (batteries excluded)
7. Measurement method: oscillometric with automatic air intake
and measurement
8. Memory size: 3 x 30 measurements with date and time
AA batteries
9. Power supply: 4 ×1.5V
10. Cuff measurement range: 0-300mmHg
11. Pressure measurement range: 40-260mmHg
12. Precision: ±3mmHg
13. Heart beat measurement range: 40-180 pulses/min; accuracy:
±5%
14. Operating environmental temperature: 5°÷40°C
15. Operating humidity level: ≤90% RH
16. Transport and storage environmental temperature: -20°÷55°C
17. Transport and storage humidity level: ≤95% RH
18. Operating environmental pressure: 80KPa-105KPa
19. Battery life: about 540 times
21
EN
STANDARDS
The product complies with the following standards:
EN 60601-1: 2006/AC 2010 (Medical electrical equipmentPart1: General requirements for safety), EN 60601-1-2: 2007/
AC: 2010 (Medical electrical equipment-Part1: General
requirements for safety; Collateral Standard-Electromagnetic
compatibility-Requirements and tests), 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), ANSI/AAMI SP-10: 2002 + A1: 2003 + A2: 2006.
INFORMATIONS ON
ELECTROMAGNETIC COMPATIBILITY
Manufacturer guide and declaration – electromagnetic
emissions
The KD-5031 device can be used in the electromagnetic
environment specified below. The customer or user of the KD5031 device must ensure it is used in such an environment.
Table 1
For all ME APPLIANCES and ME SYSTEMS
Emissions Test
Conformity
RF emissions
CISPR 11
Group 1
22
Guide to the Electromagnetic
environment
The KD-5031 device uses RF energy
only for its internal function. Therefore,
its RF emissions are very low and do not
cause any interference in any nearby
electronic appliance.
EN
CISPR 11 RF
Emissions
Harmonic
Emissions
IEC/EN 61000-3-2
Flicker/voltage
flicker
IEC/EN 61000-3-3
Class B
Not applicable
Not applicable
The KD-5031 device is suitable for use
in all environments, including the home
and those directly connected to the
distribution network that supplies power
to domestic premises.
Table 2
For all ME APPLIANCES and ME SYSTEMS
Immunity Test
Test level
IEC/EN
60601
Level of
Conformity
Electrostatic
Discharges
(ESD)
IEC/EN 61000-4-2
± 6 kV with
contact
± 8 kV in air
± 6 kV with
contact
± 8 kV in air
Magnetic field
IEC/EN 61000-4-8
3 A/m
3 A/m
Guide to the
Electromagnetic
environment
The floors should be
made of wood, cement
or ceramics. If the
floors are covered in
synthetic material, the
relative humidity should
be at least 30%.
The magnetic field
should be that of a
typical commercial or
hospital environment.
NOTE: Ut is the value of the power supply voltage before applying
the test level.
23
EN
Table 3
For all ME APPLIANCES and ME SYSTEMS that are not LIFE
supporting
Immunity
Test
Radiated
RF
IEC/EN
61000-4-3
24
Test level
IEC/EN
60601
3 V/m from 80
MHz to 2.5
GHz
Level of
Conformity
3 V/m
Guide to the
Electromagnetic environment
Portable and mobile appliances
for RF communications must be
used outside the recommended
separation distance, calculated
with the applicable equation, with
respect to any part of the KD5031 device, including wires, at
the transmitter frequency.
Recommended separation
distance:
d = 1.2 √P from 80 MHz to 800
MHz
d = 2.3 √P from 800 MHz to 2.5
GHz
Where P is the maximum rated
power of the transmitter in watts
(W) according to the transmitter
manufacturer and d is the recommended separation distance in
metres (m).
Electromagnetic fields from fixed
transmitters to RF, such as those
generated by an electromagnetic
environment surveillance system
(note a), must be below the level
of conformity of each frequency
range (note b).
There may be interference near
appliances marked with the
following symbol:
EN
NOTE 1 At 80 MHz and 800 MHz, the highest frequency range is
applied.
NOTE 2 These guidelines may not apply to all situations.
Electromagnetic propagation is affected by the absorption and
reflection of the structures, objects and persons.
Note a) Electromagnetic fields from fixed transmitters,
such as a base station for radio telephones (mobile/cordless
phones), amateur radio, AM and FM radio transmissions and TV
transmissions cannot be foreseen accurately in theory. To evaluate
the electromagnetic environment due to fixed RF transmitters,
consider an electromagnetic surveillance system. If the field force
measured in the environment where the KD-5031 device is used
exceeds the above RF applicable level of conformity, the normal
operation of the KD-5031 device must be verified. If anomalous
behaviour is noted, additional measurements are necessary, such
as redirecting or relocating the KD-5031 device.
Note b) Exceeding the frequency range from 150 kHz to 80 MHz,
the field forces must be less than 1 V/m.
Table 4
Recommended separation distances between a mobile and
portable RF appliance and the KD-5031 device
The KD-5031 device is suitable for use in an electromagnetic
environment where the radiated RF interferences are controlled.
The customer or user of the KD-5031 device can help avoid
electromagnetic interference by keeping a minimum distance
between the mobile and portable RF transmitting appliance and
the KD-5031 device as recommended below, in accordance with
the maximum output power of the transmitter.
25
EN
Maximum
rated power
of the transmitter
W
Separation distance according to the transmitter
frequency m
150 kHz to 80
MHz
d = 1.2√P
80 MHz to 800
MHz
d = 1.2√P
800 MHz to 2.5
GHz
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 with a maximum rated power that is not shown
in the list above, the recommended separation distance d in
metres (m) can be calculated using the equation at the transmitter
frequency, where P is the maximum rated output power of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 From 80 MHz to 800 MHz, the separation distance for the
highest frequency range is applied.
NOTE 2 These guidelines may not apply to all situations.
Electromagnetic propagation is affected by the absorption and
reflection of the structures, objects and persons.
ANDON HEALTH CO., LTD.
No. 3 Jin Ping Street, Ya An Road, Nankai
District, Tianjin 300190, China
Lotus Global Co., Ltd.
1 Four Season Terrace West Drayton,
Middlesex, London, UB7 9GG, United Kingdom
26
MI002407
0516 (MMYY)
Distributed by Tenacta Group S.p.A.
Via Piemonte 5/11
24052 Azzano S. Paolo (BG) ITALY
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