PO#2B1655 TMB-1018-A (EN)说明书(A0)

PO#2B1655 TMB-1018-A (EN)说明书(A0)
TMB-1018-A
(EN)说明书(A0)
印色:单黑
材质:80g书写纸
尺寸:100*142 mm
Version:1.0
User Manual
Blood Pressure Monitor
TMB-1018-A
Arm Type
IFU/TRANSTEK/TMB-1018-A/EN/2016_01
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
EC REP
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1018-A.
To use the monitor correctly and safely, please read the manual
thoroughly.
Please keep this manual well in order to reference in future.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION……………………………………………………………………………………2
General Description
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START…………………………………………………………………………......6
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
MEASUREMENT…………………………………………………………………………………...9
Tie the Cuff
Start the Measurement
DATA MANAGEMENT………………………………………………………………………….....11
Recall the Records
Delete the Records
INFORMATION FOR USER……………………………………………………………………...13
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE…………………………………………………………………….15
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING…………………………………………………………………………….17
SPECIFICATIONS…………………………………………………………………………………18
AUTHORIZED COMPONENT ………………………………………………………………......19
CONTACT INFORMATION…………………………………………………………………….....19
COMPLIED EUROPEAN STANDARDS LIST………………………………………………….20
EMC GUIDANCE……………………………………………………………………………….....21
1
INTRODUCTION
INTRODUCTION
CAUTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1018-A). The monitor features blood pressure measurement, pulse rate
measurement and the result storage. The design provides you with two years of
reliable service.
This manual contains important safety and care information, and provides step
by step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
140*36mm Digital LCD display
Maximum 60 records per user
Measuring during inflation technology
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
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 “COMPLIES WITH
MDD 93/42/EEC REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
2
EC
REP
Symbol for “Authorised Representative
in the European Community
Caution: These notes must be observed
to prevent any damage to the device
This device is intended for adult use only.
This device is intended for no-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than the arm or for functions other than
obtaining a blood pressure measurement.
Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure.Do not begin 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
to measure your blood pressure. Never change a prescribed medication without consulting
your Physician.
When the device was used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should
the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the
arm and press the START/STOP button to stop inflation.
The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries /adapter and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
The user must check that the equipment functions safely and see that it is in proper working
condition before being used.
This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
Manufacturer will make available on request circuit diagrams, component parts list etc.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple
due to a lack of blood.
Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or irritation reaction.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
The device doesn’t need to be calibrated within the two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according
to the local guidelines.
If you have any problems with this device, such as setting up, maintaining or using, please
contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by
yourself.
Please report to Transtek if any unexpected operation or events occur.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
3
INTRODUCTION
INTRODUCTION
LCD Display Signal
Monitor Components
CUFF
AIR HOSE
SYMBOL
4
DESCRIPTION
DC POWER SOCKET
EXPLANATION
Systolic blood pressure
High pressure result
Diastolic blood pressure
Low pressure result
Pulse per minute
Beats per minute, BPM
Deflating
CUFF air is exhausting of deflating
Time (hour:minute)
Currently time
Memory
If “M” shows, the displayed measurement
values are from the memory.
mmHg
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
kPa
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Low battery
Batteries are low and need to be replaced
Shocking reminding
Shocking will result in inaccurate
Average
The average of blood pressure
Recalling
The records will be showed
Arrhythmia
Irregular heartbeat
Grade
The grade of the blood pressure.
Date
“M” shows the month, “D” shows the day
SET BUTTON
START/STOP BUTTON
MEM BUTTON
LCD DISPLAY
BATTERY COMPARTMENT
AIR CONNECTOR PLUG
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1.Blood Pressure Monitor
(TMB-1018-A)
2.Cuff Type BF applied part
3. 4*AAA batteries
4.User manual
5
BEFORE YOU START
BEFORE YOU START
The Choice of Power Supply
Setting Date, Time and Measurement Unit
1.Battery powered mode:
It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each record that
is stored in the memory. (The setting range of the year :2000—2050,
time:24 H)
6VDC 4*AAA batteries
2.AC adaptor powered mode:
6V
1A
(Please only use the recommended AC
adaptor model) (Not Included).
Please unplug the adaptor to depart from
the using utility power.
AC adaptor
CAUTION
1.When the monitor is off,
hold pressing “SET”
for 3 seconds to enter
the mode for year
setting.
In order to get the best effect and protect your monitor,please use the right
battery and special power adapter which complies with CE safety standard.
Installing and Replacing the Batteries
• .Slide off the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
• .Replace the cover.
shows
The display dims
The display does not light up
START STOP
SET
MEM
START STOP
SET
MEM
START STOP
SET
2.The [YEAR] blinks,
press the “MEM”
button to change
the numeral of
the year.
Replace the batteries whenever the below happen
The
MEM
3.When you get the
right year, press
“SET” to set down
and turn to next step.
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.
Do not dispose of batteries in fire. Batteries may explode or leak.
6
7
BEFORE YOU START
MEASUREMENT
Tie the Cuff
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
MEM
START STOP
SET
MEM
START STOP
SET
MEM
START STOP
SET
MEM
START STOP
SET
1.Tie the cuff on your upper arm,
then position the tube off-center
toward the inner side of arm in
line with the little finger.
5.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
MEM
START STOP
SET
MEM
START STOP
SET
MEM
START STOP
SET
MEM
START STOP
SET
6.Repeat steps 2 and 3 to set the [UNIT].
MEM
START STOP
SET
7.After the unit is set,the right picture
will show,then it turn off .
8
MEM
START STOP
SET
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
2~3cm
3.Sit comfortably with your tested
arm resting on a flat surface.
Rest for 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison,
try to measure under similar
conditions. For example, take daily
measurements at approximately
the same time, on the same arm,
or as directed by a physician.
9
MEASUREMENT
DATA MANAGEMENT
Start the Measurement
Recall the Records
1.When the monitor is off,press the
“START/STOP” to turn on the
monitor, and it will finish the whole
measurement.
1. When the monitor is off, press the
“MEM” to show the
average of the last three
measurement records.
MEM
START STOP
SET
LCD display
MEM
START STOP
SET
MEM
S TA R T S T O P
SET
The sign of "AVG"
will show in the right
corner.
Adjust the zero.
2. Press the “MEM”
or “SET” to get the
record you want.
UP
DOWN
The Order Number of
The corresponding
the measurement: 1.
date is August 8th.
Total three records.
The corresponding
time is 13:28.
Inflating and measuring.
The order of
the record,date,
time will display
alternately.
Display and save the
results.
CAUTION
2.Press the “START/STOP” to
power off, otherwise it will turn
off within 1 minute.
10
MEM
START STOP
SET
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.
11
DATA MANAGEMENT
INFORMATION FOR USER
Delete the Records
If you did not get the correct measurement, you can delete all
results by following steps below.
1.When the monitor is off,
hold pressing “MEM”
for 3 seconds ,the
flash display will
show.
2.Press “SET” to
confirm deleting and
the monitor will turn
off .
3.If you don’t want to delete the
records, press “START/STOP” to
escape.
MEM
MEM
MEM
STA R T S T O P
START STOP
START STOP
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
SET
Immediate measurement
after dinner or drinking
Immediate measurement
after tea, coffee, smoking
Immediate measurement
after taking a bath
When talking or moving your fingers
In a very cold environment
When you want to discharge urine
SET
SET
4. If there is no record.
the right display will
show.
12
13
INFORMATION FOR USER
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
Maintenance
In order to get the best performance, please follow the
instructions below.
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.
Systolic
Diastolic
press
relax
blood discharging
artery
blood entering
vein
What is the standard blood pressure classification?
Put in a dry place and avoid the sunshine
Avoid touching water,
clean it with a dry cloth in case.
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.
Level
Avoid intense shaking
and collisions
Avoid dusty and unstable
temperature environment
Optimal
Normal
High-normal
SYS
<120
120-129
DIA
<80
80-84
Blood
Pressure (mm Hg)
Mild
Moderate
Severe
130-139
140-159
160-179
≥180
85-89
90-99
100-109
≥110
Irregular Heartbeat Detector
An irregular heartbeat is detected when a 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 25%,the irregular heartbeat symbol
appears on the symbol when the measurement results are displayed.
Using wet cloths to remove dirt
Avoid washing the cuff
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an
irregular heart-beat 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.
14
15
ABOUT BLOOD PRESSURE
TROUBLESHOOTING
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
Why does my blood
pressure fluctuate
throughout the day?
1. Individual blood pressure varies
multiple times everyday. It is also affected
by the way you tie your cuff and your
measurement position, so please take the
measurement under the same conditions.
2.If the person takes medicine, the
pressure will vary more.
3.Wait at least 3 minutes for another
measurement.
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.
Is the result the same
if measuring on the
right arm?
It is ok for both arms, but there
will be some different results for
different people. We suggest you
measure the same arm every time.
16
PROBLEM SYMPTOM
No power
Low
batteries
What 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 upper arm.
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.
Error
message
Display will not
light up.
Display is dim
or show
CHECK THIS
REMEDY
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries
correctly
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Batteries are low.
Replace with new batteries
E 1 shows
The cuff is not secure.
Refasten the cuff and then
measure again.
E 2 shows
The cuff is very tight
Readjust the cuff ,not too
loose or too tight and then
measure again.
E 3 shows
The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E10 or E11
shows
E20 shows
E21 shows
EExx,shows on
the display.
The monitor detected
Relax for a
motion,talking or the
moment and then
measure again.
pluse is too poor
while measuring.
The measurement
Loosen the clothing on the
process does not detect arm and then measure
the pulse signal.
again
The treatment of the
Relax for a moment and
measurement failed.
then measure again.
A calibration error
occurred.
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.
17
SPECIFICATIONS
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Battery powered mode:
6VDC 4*AAA batteries
AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model) (Not Included).
Digital LCD V.A.140mm*36mm
Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Pressure:
5℃-40℃within±0.4kPa(3mmHg)
pulse value:±5%
Temperature:5℃ to 40℃
Relative humidity ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20℃-60℃
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Measurement perimeter
of the upper arm
About 22cm~32cm
External dimensions
Attachment
Authorized Component
1.Please use the TRANSTEK
authorized adapter
(Not Included).
Oscillographic testing mode
Storage & transportation
condition
Net Weight
18
AUTHORIZED COMPONENT
Approx.270g(Excluding the dry cells)
Approx.180mm*100mm*40mm
Adapter
Type: UE08WCP-060100SPA
Input:100~240V,50~60Hz,400mA
Output:6V
1A
( Conforms to UL certificate )
Contact Information
For more information about our products, please visit www.transtek.cn.you
can get customer service, usual problems and customer download, transtek will
serve you anytime.
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Authorized European Representative:
Company: MDSS - Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany
4*AAA batteries,user manual
Mode of operation
Continuous operation
Degree of protection
Type BF applied part
Protection against
ingress of water
IP21
Software Version
V01
WARNING: No modification of this equipment is allowed.
19
COMPLIED EUROPEAN
STANDARDS LIST
EMC GUIDANCE
Complied European Standards List
Risk management
Labeling
User manual
EN 980:2008 Symbols for use in the labelling of medical
devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
General
Requirements for
Safety
EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
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
Electromagnetic
compatibility
EN 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
20
EN ISO 14971:2012 Medical devices - Application of risk
management to medical devices
EN ISO 81060-1:2012 Non-invasive sphygmomanometers
- Part 1: Requirements and test methods for non-automated
measurement type
EN 1060-3:1997+A2:2009 Non-invasive
sphygmomanometers - Part 3: Supplementary requirements
for electro-mechanical blood pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part
4: Test procedures to determine the overall system accuracy
of automated non-invasive sphygmomanometers
EN 60601-1-6:2010 Medical electrical equipment - Part
1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN 62366:2008 Medical devices - Application of usability
engineering to medical devices
EN 62304:2006/AC: 2008 Medical device software Software life cycle processes
EMC Guidance
1) * This product needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided, and
this unit can be affected by portable and mobile RF communications equipment.
2) * Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3) * Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
4) * Caution: This machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine should
be observed to verify normal operation in the configuration in which it will be
used.
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
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Compliance
Electromagnetic environment - guidance
Group 1
The device 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.
Class B
Not applicable
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Not applicable
21
EMC GUIDANCE
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
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
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 60601 test level
±6 kV contact
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power supply lines
±1 kV for
input/output lines
Surge IEC
61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT
for 0.5 cycle
)
70% UT
(30% dip in UT
for 25 cycles
±6 kV contact
±8 kV air
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
)
Not applicable
IEC 61000-4-8
NOTE
22
3A/m
IMMUNITY test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3A/m
UT is the a.c. mains voltage prior to application of the test level.
Compliance
level
Electromagnetic environment guidance
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Recommended separation distance
Not applicable
d = 1,2 P
3 V/m
d = 1,2 P 80 MHz to 800 MHz
d = 2,3
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
NOTE 2
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
IEC 60601
TEST LEVEL
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.
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
(50/60Hz)
magnetic field
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
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
)
40% UT
(60% dip in UT
for 5 cycles
<5% U T
(>95% dip in UT
for 5 s
Compliance level
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
At 80 MHz and 800 MHz, the higher frequency range applies.
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 broad-cast 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.
23
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 (transmittters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1,2 P
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1,2 P
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 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.
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