User`s Manual

User`s Manual
User's Manual
LEICKE Sharon Blood Pressure Monitor
with Bluetooth
Product number: LH67402
Thank you for purchasing the Blood Pressure Monitor from LEICKE Sharon.
We continuously work on the development of our products, our customer support and
innovations. Our products have a long service life, are eco-friendly and high performing.
Furthermore, every day we do our very best to satisfy you as our customer. That is why
you, no matter if private or business customer, are in the focus of our company’s efforts.
We take your reviews and proposals seriously and evaluate them continuously. That way,
we get to know you and your demands on our products and services better and thus
allow for positive enhancements.
To discover more about LEICKE products or if you have any questions about this product
visit our website www.leicke.com.
PACKAGE CONTENTS
Before attempting to use this device, please check the packaging and make sure the
following items are contained in the package:
Number of
Name
Note
Pieces
Blood Pressure Monitor (USB
1
Bluetooth 4.0
interface)
2
USB Cable
1
User's Manual
-
TECHNICAL DETAILS
Input voltage
Input current
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Degree of protection
Protection against
ingress of water
Software version
Device classification
RF Frequency Range
Transmitting Distance
Weight
Dimensions
USB, 5V
60mA
Oscillographic testing mode
Rated cuff pressure:
0mmHg-300mmHg(0kPa-40kPa)
Measurement pressure: 40mmHg-230mmHg
( 5.3kPa-30.7kPa )
pulse value:(40-199)beat/minute
Pressure:
5°C – 40°C within ± 3mmHg (0.4kPa)
pulse value: ±5%
Temperature: 5°C to 40°C
Relative humidity: ≤ 85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature: -20°C to 60°C
Relative humidity: 10%RH to 93%RH
Atmospheric pressure: 50kPa to 106kPa
Type BF applied part
IP22
V01
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor charged Mode:
Class II ME Equipment
2402 MHz to 2480 MHz
10 m
108 g
Size: 79.8 mm x 72.5 mm x 13.2 mm
PRODUCT INFORMATION
The device features blood pressure measurement, pulse rate measurement and the
result storage. Readings taken by this device are equivalent to those obtained by a
trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step by step
instructions for using the product.
Please do read this user manual carefully and thoroughly before use.
FEATURES:




Systolic Blood Pressure
Diastolic Blood Pressure
Pulse Rate
Memory: Up to 60 pieces of records
MEASUREMENT PRINCIPLE
This product uses the Oscillometric Measuring Method to detect blood pressure.
Before every measurement, the unit establishes a “zero point” equivalent to the
atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects
pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the
systolic pressure and diastolic pressure as well as pulse rate.
The device also compares the longest and the shortest intervals of detected pulse wave
with the average value, and then calculates the standard deviation.
The monitor will light up a warning symbol when the calculated standard deviation
is larger than or equal to 15.
SAFETY INFORMATION
The signs below might be in the user manual, labelling or other components.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “COMPLIES WITH
MDD 93/42/EEC
REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
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 “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “Including RF
transmitter”
Symbol for “Authorised
Representative in the European
Community”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “MANUFACTURE
DATE”
INDICATIONS FOR USE
The LEICKE Sharon Blood Pressure Monitor is a digital monitor intended for
measuring blood pressure and heartbeat rate with wrist circumferences ranging
from 13.5 cm to 21.5 cm ( about 5¼ inches to 8½ inches ).
It is intended for adult indoor use only.
CAUTION:
* Intended for adult indoor use only. Pregnant women, neonatal patients, pre-eclamptic patients and
patients with severe obesity must not use the device. If in need, please consult a professional doctor.
* Intended for non-invasive measuring and monitoring of arterial blood pressure. Not intended for use
on extremities other than wrist or for functions other than obtaining a blood pressure measurement.
* Please use device under user manual specified environment, otherwise accuracy
may be influenced.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood
pressure. Do not start or end medical treatment without asking a physician for treatment advice.
* If you are taking medication, consult your physician to determine the most appropriate time for your
measurement. Never change a prescribed medication without your physician’s consent.
* If the cuff’s pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate.
If the cuff doesn’t deflate when its pressure exceeds 40 kPa (300 mmHg), detach cuff from wrist and
press the START/STOP button to stop inflation.
* Do not use the monitor under a strong electromagnetic field (e.g. medical RF equipment) that
radiates interference signals or electrical fast transient/ burst signals.
* The maximum temperature of the device is 42.5°C the environmental temperature being 40°C.
* The device is not AP/APG equipment. It is not suitable for use in the presence of a flammable
anaesthetic mixture with air (or oxygen, nitrous oxide).
* Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small
parts is dangerous or even fatal.
* Please use ACCESSORIES and detachable parts specified / authorised by MANUFACTURER.
Otherwise, it may cause damage to the unit or endanger the user / patient.
* The patient is an intended operator. The patient can measure, transmit data and charge battery
under normal circumstances and maintain the device and its accessories according to the user
manual.
* The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient's
environment. If you are allergic to dacron or plastic, please don’t use this device.
* The device is not intended for PATIENT transport outside a healthcare facility.
* This device cannot be used with HF surgical equipment at the same time.
* There is a PTC current limiter in the monitor, whose specification is 8V and 0.5A. When the voltage
and current exceed the limiting value, the monitor will stop working.
* The adaptor is specified as a part of ME equipment.
* The device is not suitable for public use.
* The adapter insulates the device from the main supply. Do not position the plug in a position where it
is difficult to disconnect from the supply mains.
* Sensitive people, including pregnant women pre-eclamptic patients, patients who implanted medical
electronic instruments and have atrial fibrillation (AF), premature ventricular beats and peripheral
arterial disease (PAD)., should avoid using the unit whenever possible.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.
* Manufacturer will make available on request circuit diagrams, component parts list etc.
LCD DISPLAY SIGNAL
SYMBOL
SYS
DIA
mmHg
DESCRIPTION
Systolic Blood Pressure
EXPLANATION
High blood pressure
Diastolic
Blood Pressure
High blood pressure
Pulse
Low Battery
Beat/minute
IHB Detector
Bluetooth
Error
Low battery - please charge
Measurement unit of blood pressure
(1mmHg=0.133kPa)
Irregular Heartbeat Detector
Successful Bluetooth Connection
Error
Memory
Recalling the history records
Time
Hour: Minute (Month/Day/Year)
Heartbeat
Heartbeat detection during the
measurement
Unit
Monitor Components
SYSTOLIC
DIASTOLIC
PULSE RATE
TIME
START/STOP BUTTON
MEM/UP
BUTTON
SET/DOWN
BUTTON
Component list of
pressure measuring system:
CUFF
(Type BF applied part)
1. PCBA
2. Air Pipe
3. Pump
4. Valve
5. Cuff
USB Interface
Charging the Device
1. The battery of the monitor is a built-in rechargeable lithium-ion battery, the battery
current is 420 mAh.
2. Please use the USB cable to charge the battery, just like the following pictures:
Method 1
Method 2
Charging the power under following circumstances:
•
displays on the LCD
• The LCD display dims
• When switching on the monitor, the LCD doesn’t light up.
CAUTION:
1. The battery of the monitor is built-in rechargeable lithium-ion battery, please do not disassemble
yourself or by unauthorized maintenance personnel.
2. When used normally, it can be charged about 300 times, if the battery cannot be charged normally
or the blood pressure monitor cannot be used normally, please contact authorized maintenance
personnel. If you measure three times per day, and the battery was fully charged, it can be used for
about 20 days.
3. Store and use the blood pressure monitor in a cool, dry and ventilated environment. Avoid fire and
heat sources, or the battery may explode.
4. Only use the authorized USB cable (5V 1A) to charge power.
5. During the charging process, the blood pressure monitor displays:
When charging is finished, please pull the plug in time.
CAUTION:
6. When charging, do not touch charging connector and patient simultaneously.
7. Do not attempt to replace your blood pressure monitor’s battery. It is built-in and not changeable.
8. Only charge the battery in accordance with the user instructions supplied with the blood pressure
monitor.
9. Avoid charging your blood pressure monitor in extremely high or low temperatures.
10. Do not use your blood pressure monitor while you are charging it.
11. Do not attempt to disassemble the blood pressure monitor or force open the built-in battery.
12. Do not clean the blood pressure monitor when it is being charged. Always
unplug the charger first before cleaning the blood pressure monitor.
13. Do not dispose of your blood pressure monitor in a fire. The battery could explode causing injury
or death.
14. Batteries (battery pack or batteries installed) shall not be exposed to excessive heat such as
sunshine, fire or the like.
Activate Your Blood Pressure Monitor
Getting the Blood Pressure Monitor, the first thing to do after charging is to activate
it. Please press and hold the SET button to activate it and enter setting mode.
Setting Date and Time
Please proceed to time setting before your initial use so as to ensure each piece of
record is labelled with a time stamp. (Year Range: 2012-2052; Time Format: 12 Hours)
1. When the monitor is OFF, press
and hold “SET” button for 3
seconds to enter Time Setting Mode.
2. As pictured in the right, the
blinking number represents the
[HOUR]. Press “MEM” button to
change the number. Each press
will increase the number by one
in a cycling manner.
3. Press “SET” button again to
confirm [HOUR]. Then the
number representing [MINUTE]
blinks.
Setting Date and Time
4. Repeat steps 2 and 3 to confirm
[MINUTE].
5. Repeat steps 2 and 3 to confirm [MONTH], [DAY] and [YEAR].
6. After confirming [YEAR], the LCD
will display “dONE” and then shut off.
Positioning the Cuff
1. Remove all accessories (watch, bracelet, etc.) from your left wrist. If your
physician has diagnosed you with poor circulation in your left wrist, use your
right wrist.
2. Roll or push up your sleeve to expose the skin.
3. Apply the cuff to your left wrist with your palm facing up.
4. Position the edge of the cuff about 1-2 cm below the wrist.
5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff
and your skin. If the cuff is too loose, the measurement will not be accurate.
6. Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the heart;
Before starting measurement, please sit comfortably with legs uncrossed, feet flat
on the floor, back and arm supported.
• Rest for 5 minutes before measuring.
• Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
• For a useful comparison, try to measure under similar conditions. For
example, take daily measurements at approximately the same time, on the same
wrist, or as directed by a physician.
PAIRING THE BLOOD PRESSURE MONITOR WITH YOUR MOBILE DEVICE
Download and install the MedM Health APP to your mobile device which supports
Bluetooth 4.0 technology from the APP Store or Google Play.
1. Turn on Bluetooth and the app.
Make sure both are ON when
pairing is proceeding.
2. When the monitor is OFF, press
and hold the START/STOP button
to start pairing. These symbols
will be shown on the LCD
alternatively, indicating pairing
is proceeding.
• If SUCCEED, this symbol will
be shown on the LCD.
• If FAIL, than this symbol
(Bluetooth ERROR)
will be shown on the LCD.
3. The monitor will shut off
after pairing process is complete.
Start Measurement
1. After correctly positioning the cuff,
press START/STOP button to turn
on the monitor, and it will complete
the measurement process.
Adjust to zero.
Inflating and measuring.
Display and save the
measuring result.
2. This device will proceed
to data transmission
after measurement.
The Bluetooth symbol
blinking on the LCD
indicates data transmission.
3. If the data is successfully
transmitted, the LCD will
display “dONE”.
If data transmission fails, the
LCD will display “BLUETOOTH ERROR” instead.
4. Press START/STOP button to turn off
the monitor. Otherwise if there is no
operation, it will switch off within 1 minute.
Recall the Records
1. Press “MEM” button to access the
memory when the monitor is off.
The monitor will display the
calculated value of the latest
readings first.
2. Press “MEM/UP” button or
“SET/DOWN” button to rotate the
history records.
“MEM/UP” to go forward;
“SET/DOWN” to go backward.
CAUTION:
The most recent record (1) is shown first. Each new measurement
is assigned to the first (1) record. All other records are pushed back
one digit (e.g., 2 becomes 3, and so on), and the last record (60) is
dropped from the list.
Delete the Records
When you did not obtain the accurate measurement, you can clear all the
measuring results by following the steps below.
1. Under Memory Recalling Mode, press
and hold both the “MEM” button and the
“SET” button for 3 seconds.
2. The LCD will display “dEL dONE”,
indicating that memory clearing is
complete. And then it will shut down.
CAUTION:
Under Memory Recalling Mode, if you
wish to give up clearing, press
“START/STOP” to turn off the monitor.
3. When there is no memory in the monitor,
if you press the “MEM” button to look up
history, the LCD will display as pictured
to the right.
Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Within 1 hour
after dinner or drinking
Immediate measurement
after tea, coffee, smoking
Within 20 minutes
after taking a bath
When talking or moving
your fingers
In a very cold environment
When you need to pee urgently
Maintenance
To obtain the best performance, please follow the instructions below.
Put in a dry place and
avoid sunshine.
Avoid shaking and collisions.
Use a slightly damp cloth
to remove dirt.
CAUTION:
Avoid immersing it in water.
Clean it with a dry cloth in case.
Avoid dusty environment and
unstable temperature surrounding.
Avoid washing the cuff.
1. Please make sure the unit functions safely and it is in proper working conditions before use. Don’t
service or maintain while the device is in use.
2. If you have any problems with this device, such as setting up, maintaining or using, please contact
the customer service. Don’t open or repair the device by yourself.
3. Please report to LEICKE if any unexpected operation or events occur.
4. Cleaning: Dust environment may affect the performance of the unit. Please use a soft cloth to
remove dirt from the device and cuff before and after use.
5. Calibration: The manufacturer does not require such preventive inspections or calibration by
other persons and will make available on request circuit diagrams, component part list, etc.
6. Disposal: Degraded sensors may result in inaccurate measurement while loosened electrodes
may cause the monitor’s failure to power on. Please dispose of ACCESSORIES, detachable
parts, and ME EQUIPMENT according to local guidelines.
About Blood Pressure
What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum
value in the cycle, which is called diastolic
pressure.
What is the standard blood pressure classification?
The blood pressure classification published by
World Health Organization (WHO) and
International Society of Hypertension (ISH) in
1999 is as follows:
CAUTION:
Only a physician can tell your normal BP range. Please contact a physician if your measuring result
falls out of the range. Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
About Blood Pressure
Irregular Heartbeat Detector:
An irregular heartbeat is detected when the heartbeat rhythm varies while the
unit is measuring the systolic and diastolic blood pressure. During each
measurement, this equipment records the heartbeat intervals and works
out the standard deviation. If the calculated value is larger than or equal to 15,
the irregular heartbeat symbol appears when the measurement results are displayed.
CAUTION:
The appearance of the IHB icon indicates that a pulse irregularity consistent
with an irregular heartbeat was detected during measurement. Usually this is
NOT a cause for concern. However, if the symbol appears often, we
recommend you seek medical advice. Please note that the device does not
replace a cardiac examination, but serves to detect pulse irregularities at an
early stage.
Why does my blood pressure fluctuate throughout the day?
Individual blood pressure varies
multiple times every day. It is also
affected by the way you tie your cuff
and your measurement position, so
please take the measurement under
the same conditions.
 If the person takes medicine, the
pressure will vary more.
 Wait at least 3 minutes for another
measurement.
About Blood Pressure
Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to
weather, emotion, exercise etc. Also, there is the “white coat” effect,
which means blood pressure usually increases in clinical settings.
What do you need to pay attention to when you measure your blood pressure at
home:
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the wrist.
If you feel anxious.
Taking 2-3 deep breaths before beginning will be better for measuring.
Advice: Relax yourself for 4-5 minutes until you calm down.
Is the result the same if measuring on the right wrist?
It is ok for both wrists, but there will be some different results for different
people. We suggest you measure the same wrist every time.
FAQ
Problem Description
No Power
Low
Batteries
Symptom
Display is dim or
will not light up.
Shows on
the display
Possible Cause/
Possible Solution
• Power is exhausted.
Please charge.
• Battery is low.
Please charge.
• Data communication
Shows
1 shows
Error
Message
2 shows
3 shows
10 or
11 shows
has failed
• Make sure that phone’s
Bluetooth is switched on or within
the distance range
• Inflation is slow
or the cuff is not secure
• Refasten the cuff and then
measure again.
• The cuff is very tight.
• Refasten the cuff and then
measure again.
• Refasten the cuff and then
measure again.
• The pressure of
the cuff is too high.
• Relax for a moment and
then measure again.
• The monitor detected motion,
talking or the pulse is too poor while
measuring.
• The device does not detect the
20 shows
pulse signal.
• Loosen the clothing on the
FAQ
Problem Description
Error
Message
Error
message
Symptom
21 shows
• EExx,shows on
the display.
• A calibration error
occurred
Possible Cause/
Possible Solution
• Relax for a moment and
then measure again.
• The treatment of the measurement
failed.
• Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance. Refer to the
warranty for contact
information and return
instructions.
Complied European Standards List
Risk management
Labelling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices
EN 980 Symbols for use in the labelling of medical devices
EN 1041: 2008 Medical equipment manufacturers to provide information
EN 60601-1: 2006 Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC/EN 60601-1-11: 2010 Medical electrical equipment -- Part 1-11: General requirements for
basic safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC/EN 60601-1-2:2007 Medical electrical equipment -Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibilityRequirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for electromechanical blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Interventional accuracy of the
testing process
IEC/EN 60601-1-6: 2010 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral Standard:
Usability
IEC/EN 62366: 2007 Medical devices - Application of usability engineering to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
EMC Guidance
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Emissions test
Compliance
RF emissions
CISPR 11
Group 2
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions IEC Not applicable
61000-3-3
Electromagnetic environment - guidance
The device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment
may be affected.
EMC Guidance
Table 2 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment
Electromagnetic
IMMUNITY test
IEC 60601 test level Compliance level environment guidance
Floors should be wood, concrete
Electrostatic
or ceramic tile. If floors are
±6 kV contact
±6 kV contact
covered with synthetic material,
discharge (ESD)
±8 kV air
±8 kV air
the relative humidity should be at
IEC 61000-4-2
least 30%.
Mains power quality should be that
±2 kV for
Electrical fast
of a typical commercial or hospital
power supply lines
±2 kV for power
transient/burst
environment.
±1 kV for
supply lines
input/output lines
IEC 61000-4-4
Mains power quality should be that
±1 kV line(s)
Surge IEC
±1 kV line(s) to
of a typical commercial or hospital
to line(s)
line(s)
environment.
61000-4-5
±2 kV line(s) to earth
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
NOTE:
<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
3A/m
<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
3A/m
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered from
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
UT is the a.c. mains voltage prior to application of the test level.
EMC Guidance
Table 4 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Compliance Electromagnetic
IEC 60601 test level
IMMUNITY test
level
environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.167√ P
d = 1.167√ P
80 MHz to 800 MHz
d = 2.333√ P
800 MHz to 2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular /
cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
EMC Guidance
Table 6 Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or ME SYSTEM –
- for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances
between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter (W)
0.01
0.1
1
10
100
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.167√ P
0.117
0.369
1.167
3.690
11.67
80 MHz to 800 MHz
d = 1.167√ P
0.117
0.369
1.167
3.690
11.67
800 MHz to 2.5 GHz
d = 2.333√ P
0.233
0.738
2.333
7.378
23.33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (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 80MHz and 800MHz, 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.
FCC Interference Statement
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 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.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:
This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
FCC-Caution: FCC Caution: Any changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate this equipment.
IMPORTANT NOTE:
Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users should follow the specific instructions in the user's manual to comply with
the FCC rules.
This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
DISPOSAL
This device contains materials that must not be disposed of as household waste. Please
check local laws concerning the applicable disposal regulations. Protect the
environment by participating in recycling programs.
CONTACT
If you have any questions, please feel free to contact us.
PRODUCTION & WHOLESALE
LEICKE GmbH
Dohnanyistr. 28
04103 Leipzig
Germany
Web: www.leicke.com
Mail: [email protected]
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