TRANSTEK TMB-1018-A User Manual

User Manual
Blood Pressure Monitor
TMB-1018-A
To use the monitor correctly and safely, please read the manual thoroughly.
Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1018-A.
Please keep this manual well in order to reference in future.
Version:1.0
EC REP
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
TMB-1018-A (EN)说明书(A0)
印色:单黑
材质:80g书写纸
尺寸:100*142 mm
IFU/TRANSTEK/TMB-1018-A/EN/2016_01
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
Table of Contents
1
CATALOGUE CATALOGUE
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
General Description
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Safety Information
Symbol for “THE OPERATION GUIDE MUST BE READ”
Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED PARTS”
Symbol for “DIRECT CURRENT”
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 “Authorised Representative in the European Community
EC REP
Symbol for “MANUFACTURE DATE”
CAUTION
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.
Caution: These notes must be observed to prevent any damage to the device
INTRODUCTION INTRODUCTION
2 3
Monitor Components
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
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
Irregular heartbeat
Arrhythmia
Grade The grade of the blood pressure.
List
1.Blood Pressure Monitor (TMB-1018-A)
4.User manual3. 4*AAA batteries
2.Cuff
Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump
5 Valve
Date
“M” shows the month, “D” shows the day
Type BF applied part
AIR CONNECTOR PLUG
BATTERY COMPARTMENT
CUFF
AIR HOSE
LCD DISPLAY
DC POWER SOCKET
MEM BUTTON
START/STOP BUTTON
SET BUTTON
54
INTRODUCTIONINTRODUCTION
Setting Date, Time and Measurement Unit
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)
1.When the monitor is off, hold pressing “SET” for 3 seconds to enter the mode for year setting.
2.The [YEAR] blinks,
press the “MEM” button to change the numeral of the year.
3.When you get the right year, press “SET” to set down and turn to next step.
The Choice of Power Supply
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.
• .Slide off the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
.Replace the cover.
1.Battery powered mode:
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.
Installing and Replacing the Batteries
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.
CAUTION
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
AC adaptor
Do not dispose of batteries in fire. Batteries may explode or leak.
STAR T STO P
TESMEM
STAR T STO P
TESMEM
STAR T STO P
TESMEM
76
BEFORE YOU START BEFORE YOU START
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.
Tie the Cuff
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.
2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.
3.Sit comfortably with your tested arm resting on a flat surface.
2~3cm
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
5.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
6.Repeat steps 2 and 3 to set the [UNIT].
7.After the unit is set,the right picture
will show,then it turn off .
START STO P
TESMEM
START STO P
TESMEM
START STO P
TESMEM
START S
TOP
TESMEM
START STO P
TESMEM
START STO P
TESMEM
START STO P
TESMEM
START STO P
TESMEM
START
STOP
TESMEM
START
ST
OP
TESMEM
98
MEASUREMENTBEFORE YOU START
Recall the Records
1. When the monitor is off, press the “MEM” to show the average of the last three measurement records.
The sign of "AVG" will show in the right corner.
2. Press the “MEM” or “SET” to get the record you want.
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.
CAUTION
The order of the record,date, time will display alternately.
1.When the monitor is off,press the “START/STOP” to turn on the
monitor, and it will finish the whole measurement.
Adjust the zero.
LCD display
Inflating and measuring.
Display and save the
results.
Start the Measurement
2.Press the “START/STOP” to
power off, otherwise it will turn off within 1 minute.
STAR T STO P
MEM SET
STAR T STO P
MEM SET
STAR T STO P
MEM SET
NWODPU
POTS TRATS
TESMEM
The Order Number of the measurement: 1. Total three records.
The corresponding date is August 8th.
The corresponding time is 13:28.
1110
DATA MANAGEMENTMEASUREMENT
Tips for Measurement
In a very cold environment
Immediate measurement after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
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.
If you did not get the correct measurement, you can delete all
results by following steps below.
Delete the Records
4. If there is no record. the right display will show.
Immediate measurement
after taking a bath
Immediate measurement
after dinner or drinking
START S TOP
TESMEM
START S TOP
TESMEM
STA TR S POT
ESMEM T
Measurements may be inaccurate if taken in the following circumstances.
1312
DATA MANAGEMENT INFORMATION FOR USER
Maintenance
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
Avoid washing the cuff
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.
What are systolic pressure and diastolic pressure?
press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
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:
Irregular Heartbeat Detector
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.
CAUTION
SYS
DIA
<120
<80
120-129
80-84
130-139
85-89
140-159
90-99
160-179
100-109
≥180
≥110
Level
Blood Pressure (mm Hg)
Optimal Normal
High-normal
Mild Moderate Severe
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.
1514
ABOUT BLOOD PRESSUREINFORMATION FOR USER
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?
Is the result the same if measuring on the right arm?
Why do I get a different blood pressure at home compared to the hospital?
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low batteries
Error message
Display will not
light up.
Batteries are exhausted.
Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted incorrectly.
Display is dim or show
Batteries are low.
E 1 shows The cuff is not secure.
Refasten the cuff and then measure again.
E 2 shows The cuff is very tight
E 3 shows
The pressure of the cuff is excess.
Relax for a moment and then measure again.
E10 or E11 shows
E20 shows
The measurement process does not detect the pulse signal.
Loosen the clothing on the arm and then measure again
EExx,shows on the display.
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.
E21 shows
The treatment of the measurement failed.
Relax for a moment and then measure again.
AC adaptor is inserted incorrectly.
Insert the AC adaptor tightly
Readjust the cuff ,not too loose or too tight and then measure again.
The monitor detected motion,talking or the pluse is too poor while measuring.
Relax for a moment and then measure again.
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.
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.
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.
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.
1716
TROUBLESHOOTINGABOUT BLOOD PRESSURE
Power supply
Battery powered mode: 6VDC 4*AAA batteries AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model) (Not Included).
Display mode
Digital LCD V.A.140mm*36mm
Measurement mode
Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
About 22cm~32cm
Net Weight
Approx.270g(Excluding the dry cells)
External dimensions
Attachment
Approx.180mm*100mm*40mm
4*AAA batteries,user manual
Mode of operation
Continuous operation
Degree of protection
Type BF applied part
Protection against ingress of water
IP21
WARNING: No modification of this equipment is allowed.
Software Version
V01
Authorized Component
1.
Please use the TRANSTEK authorized adapter (Not Included).
Adapter
Input:100~240V50~60Hz,400mA Output:6V 1A
Type: UE08WCP-060100SPA
( 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.
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
Rated cuff pressure: 0kPa - 40kPa (0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg) pulse value: (40-199) beat/minute
Pressure: 5-40within±0.4kPa(3mmHg) pulse value:±5%
Authorized European Representative:
Manufactured by: Company: Address:
Company:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
18 19
AUTHORIZED COMPONENTSPECIFICATIONS
COMPLIED EUROPEAN STANDARDS LIST
EMC GUIDANCE
EMC Guidance
Complied European Standards List
20 21
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
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.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
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.
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.
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.
Risk management
Labeling
User manual
General Requirements for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle processes
EN ISO 14971:2012 Medical devices - Application of risk
management to medical devices
EN 980:2008 Symbols for use in the labelling of medical
devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
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
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
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 EMC GUIDANCE
22 23
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
±2 kV for power supply lines
Not applicable
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5% U
T
(>95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U
T
(>95% dip in UT) for 5 s
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2
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%.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
3A/m
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
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
±1 kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
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
IMMUNITY test
Not applicable
3 V/m
Compliance level
IEC 60601 TEST LEVEL
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to
2.5 GHz
3 Vrms
150 kHz to 80 MHz
Electromagnetic environment ­guidance
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
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.
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, should be less than the compliance level in each frequency range.
a
b
Interference may occur in the vicinity of equipment marked with the following symbol:
P
=d
P
=d
80 MHz to 800 M Hz
P
=d 2,3
800 MHz to 2,5 GHz
1,2
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 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
1,2
EMC GUIDANCE
24
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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)
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.
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
=d
P
=d 1,2
2,3
P
=d
0.38
1.2
3.8
12
P
1,2
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