CAPES TD-3128 Blood Pressure Monitoring System Instruction Manual

TD-3128 Blood Pressure Monitoring System

ri-champion®

Ver 1.0 2020/06 311-3128000-015

smartPRO & smartPRO+ (TD-3128)

BLOOD PRESSURE MONITORING SYSTEM OBERARM BLUTDRUCKMESSGERÄT SYSTÈME DE SURVEILLANCE DE LA PRESSION ARTÉRIELLE SISTEMA DI MONITORAGGIO DELLA PRESSIONE ARTERIOSA SISTEMA DE CONTROL DE PRESIÓN SANGUÍNEA

Operation Instruction / Gebrauchsanleitung / Mode d’emploi / Manuale dell’utente / Instrucciones de Operación /

EN
Dear ri-champion® smartPRO/smartPRO+ (TD-3128) owner:
Thank you for purchasing the smartPRO/smartPRO+ (TD-3128) Blood Pressure Monitoring System. This manual provides important information to help you to use this system correctly. Before using this product, please read the following contents thoroughly and carefully.
With the compact size and easy operation of this smartPRO/smartPRO+ (TD3128) Blood Pressure Monitoring System, you can easily monitor your blood pressure by yourself at any time or place. In addition, this system can help you and your healthcare professionals to monitor and adjust your treatment plans, and keep your blood pressure under control.
If you have other questions regarding this product, please contact the place of purchase.
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this manual. 2. Do NOT use accessories which are not specified by the manufacturer. Other
cables and accessories may negatively affect EMC performance. 3. Do NOT use the device if it is not working properly or damaged. 4. Do NOT use under any circumstances on newborns or infants. 5. This device does NOT serve as a cure for any symptoms or diseases. The data
measured are for reference only. Always consult your doctor to have the results interpreted. 6. Keep the equipment and its flexible cord away from hot surfaces. 7. Do NOT apply the cuff to areas other than the place directed. 8. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.
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9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
10.Proper maintenance is essential to the longevity of your device. If you are concerned about your accuracy of measurement, please contact local customer service for help.
11. Be careful to strangulation due to cables and hoses, particularly due to excessive length.
12.Do not try to maintain the device while it is in use. 13.Keep the unit out of reach of small unsupervised children. 14.Do not try to modify the device to prevent any dangers. 15.Do not place the device in liquid, nor put it where it could fall into liquid. If the
device becomes wet, unplug the device before touching it. 16.For the reason of maintain basic safety and essential performance in regards
to EMC, please always contact the manufacturer or the manufacturer’s representative to report unexpected operation or event. Do not try to fix it by yourself. 17.When in use, you should stay away from electromagnetic radiation, such as the mobile in use. 18.Used in close proximity or stacking to others, EMC must be tested and verified. 19.If abnormal behavior is observed due to EM disturbances, please relocate the device accordingly.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
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TABLE OF CONTENTS

BEFORE YOU BEGIN

04

INTENDED USE

04

TEST PRINCIPLE

04

METER OVERVIEW

04

DISPLAY SCREEN

05

SETTING THE METER

05

USER NUMBER SELECTION

08

TESTING YOUR BLOOD PRESSURE

09

BEFORE MEASUREMENT

09

SELECTING THE CORRECT CUFF

09

FITTING THE CUFF PROPERLY

09

PROPER MEASUREMENT POSITION

10

TAKING MEASUREMENTS

11

AVERAGING MEASUREMENT MODE

12

METER MEMORY

13

REVIEWING TEST RESULTS

13

DOWNLOADING RESULTS

13

MAINTENANCE

15

BATTERY

15

USING AC ADAPTER (optional)

16

CARING FOR YOUR METER

16

DETAILED INFORMATION

17

REFERENCE VALUES

17

SYSTEM TROUBLESHOOTING

18

ERROR MESSAGES

18

TROUBLESHOOTING

19

SYMBOL INFORMATION

20

SPECIFICATIONS

21

SYSTEM PERFORMANCE

21

BLOOD PRESSURE MEASUREMENT PERFORMANCE

21

3

BEFORE YOU BEGIN
INTENDED USE
The smartPRO/smartPRO+ (TD-3128) system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings by one with a good understanding of the operation instruction, where the patient may be an operator. The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns.

TEST PRINCIPLE
Blood pressure is measured non-invasively at the arm based on oscillometric method.
This device is NOT able to take measurements in the presence of common arrhythmia, such as atrial or ventricular premature beats or atrial fibrillation. It may produce reading error.

METER OVERVIEW

1

2

4

3

5

1 DISPLAY SCREEN
2 M BUTTON Enter the meter memory.
3 USER SELECTION BUTTON Assist you with user number selection.
4 ON/OFF BUTTON
5 BATTERY COMPARTMENT
6 AC ADAPTER PORT Connect to a power supply.

6 8
7 9 10
11
7 AIR JACK 8 PRESSURE CUFF
9 AIR TUBE
10 AIR PLUG 11 BT INDICATOR (ri-champion®
smartPRO+ only)
4

DISPLAY SCREEN

1

15

14

2

13

3

4

12

11 5
10 6

7

9

8

1 Error Warning

9 Pulse Rate

2 Systolic Pressure Value

10 Average

3 Diastolic Pressure Value

11 AC Adaptor Symbol

4 Low Battery Symbol

12 Units of Blood Pressure

5 Movement During Measurement 13 Diastolic Pressure Symbol

6 Memory Mode Symbol

14 Systolic Pressure Symbol

7 Pulse Rate Symbol

15 Time & Date

8 User Number

SETTING THE METER
Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete the steps below and save the desired settings.

Entering the Setting Mode Start with the meter off. Press and firmly hold
on.
5

for 3 seconds until the meter turns

Setting the Date and the Time
With the year flashing, press Press to set.

until the correct year appears.

With the month flashing, press until the correct month appears.Press to set.

With the day flashing, press Press to set.

until the correct day appears.

With the hour flashing, press Press to set.

until the correct hour appears.

6

With the minute flashing, press appears. Press to set.

until the correct minute

Setting the Time Format

Press to select the desired time format –12h or 24h. Press to set.

Setting the Unit of Measurement
Press to select mmHg or KPa. Press to set.

Delete The Memory

While “dEL” and a flashing ” ” symbol appears on the display, if you do not wish to delete the saved results, press to skip this step. To delete ALL the results, press twice. ” ” and ” ” are displayed on the meter, which indicates that all results have been deleted.
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Enter the Bluetooth Pairing (ri-champion® smartPRO+ only) NOTE This step is recommended when the user needs to pair this meter to a Bluetooth receiver for the first time, or when user needs to pair this meter to another new Bluetooth receiver. If you wish to enter the pairing mode, with “PAr OFF” shows on the meter, press once and the meter will display “PAr On” to enable Bluetooth pairing mode.
Congratulations! You have completed all settings!
NOTE · These parameters can ONLY be changed in the setting mode. · If the meter is idle for 3 minutes during the setting mode, it will turn off auto-
matically.
USER NUMBER SELECTION
This system stores blood pressure measurements for up to four users. Each user’s test results are stored separately under each user number.
1. Press to select the desired user number. 2. Press to confirm. The monitor will repeat
the selected user number and then turn off automatically.
8

M

TESTING YOUR BLOOD PRESSURE
BEFORE MEASUREMENT
· Avoid caffeine, tea, alcohol and tobacco for at least 30 minutes before measurement.
· Wait 30 minutes after exercising or bathing before measurement. · Sit or lie down for at least 10 minutes before measurement. · Do not measure when feeling anxious or tense. · Take a 5-10 minute break between measurements. This break can be longer if
necessary, depending on your physical condition. · Keep the records for your doctor as reference. · Blood pressure naturally varies between each arm. Always measure your blood
pressure on the same arm.
SELECTING THE CORRECT CUFF
Two different cuff sizes are provided with the blood pressure monitoring system: Small and Wide. Select the cuff size that best matches the circumference of the patient’s upper arm.
S (Small size) 15-24cm (5.9-9.4 inches)
W (Wide size) 24 ­ 43 cm (9.4 ­ 16.9 inches)
FITTING THE CUFF PROPERLY
1. Connect the air plug of the tubing to the air jack of the meter.
2. Assemble the cuff as shown. The smooth surface should be inside of the cuff loop and the metal D-ring should not touch your skin.
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W

Pile Side Material Sewn Hook Material
D-Ring 2-3 cm Main Arterles

3. Stretch your left (right) arm in front of you with your palm facing up. Slide and place the cuff onto your arm with the air tube and artery mark region toward the lower arm.Wrap and tighten the cuff above your elbow. The bottom edge of the cuff should be approximately 0.8″ to 1.2″ (2 cm to 3 cm) above your elbow. Align the tube over the main arteries on the inside.
4. Leave a little free space between the arm and the cuff; you should be able to fit two fingers between them. Clothing must not restrict the arm. Remove all clothing covering or constricting the measurement arm.

5. Press the hook material firmly against the pile material. The top and bottom edges of the cuff should be tightened evenly around your upper arm.

The range index of cuff should fall within this range
PROPER MEASUREMENT POSITION
1. Sit down for at least 10 minutes before measuring.
2. Place your elbow on a flat surface. Relax your hand with the palm facing up.
3. Make sure the cuff is about the same height as the location of your heart. Press . Remain still and do not talk or move during the measurement.
WARNING If the cuff is relatively lower (higher) than the heart, the obtained blood pressure value could be higher (lower) than the actual value. A 15 cm difference in height may result in an error around 10 mmHg.
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4. Measurement is in progress. After the meter is turned on, the cuff will begin to inflate automatically.

TAKING MEASUREMENTS
Always apply the pressure cuff before turning on the meter.

1. Press . All the LCD symbols will appear. Press to select

user ”

” (numbers from 1 to 4) whose test reading

will be stored in its memory. Then the cuff will begin to inflate

automatically.

2. The heart symbol ” the measurement.

” will flash when pulse is detected during

3. After the measurement, the meter displays the systolic pressure, diastolic pressure and pulse rate.

4. Press to switch off or it will switch off automatically after being idle for 3 minutes.
5. The meter will enter Bluetooth mode automatically. (ri-champion® smartPRO+ only)

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NOTE

· If you press during measurement, the meter will be turned off.

· If the pulse rate symbol is shown as ”

” instead of ” “, this indicates

that the meter has detected an irregular heart beat.

AVERAGING MEASUREMENT MODE
Always apply the pressure cuff before turning on the meter.

1. Press and hold until the meter displays

“AVERAGE”, then press to select user

”

” (numbers from 1 to 4) whose test

reading will be stored in its memory. Then the

cuff will begin to inflate automatically.

2. After the first measurement is completed, the meter will start counting down before the second measurement begins. The number on the right represents the remaining countdown between each measurement. The meter will take three (3) measurements consecutively with intervals of 20 seconds.

3. After taking three measurements, the results are averaged to produce the blood pressure measurement with “AVERAGE” symbol display on the meter. Press to turn off the meter.
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METER MEMORY
Your meter stores the 400 most recent blood pressure test results along with respective dates and times in the meter memory. To recall the memory, start with the meter off.

REVIEWING TEST RESULTS

1. Press and release . The user symbol

”

” (numbers from1 to 4) appears

first, press to select which one you used

to store in the memory.

2. Press again, and the first reading you see is the last blood pressure result along with date and time.
3. Press Review all test results stored in the meter.
4. Exit the memory Press and the meter will turn off.

DOWNLOADING RESULTS
Data Transmission via Bluetooth (ri-champion® smartPRO+ only) You can transmit your blood pressure monitoring data from the meter to your device via Bluetooth. Please contact your local customer service or place of purchase for assistance.
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How to Install and Update the Healthy Check App You must connect to the internet to download the app. The App Store or Google Play can be accessed by tapping the App Store or Play Store icon on your iOS or Android devices. It is simple and intuitive to use, for better understanding of your current condition and to achieve better blood pressure control.

System Requirement For the requirement of OS version, please find on App Store or Google Play when you download the app. Please contact your local customer service or place of purchase for assistance. Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data.

Pairing with your mobile device
1. Turn on the Bluetooth function on your mobile device. 2. Start with the meter off. Press and firmly hold for 3 seconds until the meter
turns on. “PCL” will appear on the meter. 3. Follow the instruction of the Healthy Check app to pair the device. (Ex. Search to
find the meter and then add it into app.) 4. After successfully pairing the app with the device, the Bluetooth function of meter
shall be on before transmitting the data to the Healthy Check app.

Bluetooth indicator on the blood pressure monitor:

BLUETOOTH INDICATOR

STATUS

Flashing Blue

The Bluetooth function is on and waiting for connection.

Solid Blue

The Bluetooth connection is established.

NOTE · While the meter is in transmission mode, it will be unable to perform a blood
pressure test. · Make sure your device supporting Bluetooth Smart Technology has turned on
Bluetooth before transmitting the data and the meter is within the receiving range. For the requirement of OS version, please find on App Store or Google Play when you download the app. · The Bluetooth functionality is implemented in different ways by the various mobile device manufacturers, the compatibility issue between your mobile device and the meter may occur.
14

MAINTENANCE
BATTERY
Your meter comes with four (4)1.5V AA size alkaline batteries.

Low Battery Signal The meter will display either of the two messages below to alert you when the meter power is getting low.

1. The

symbol appears along with display messages: The

meter is functional and the result remains accurate, but it is

time to change the batteries.

2. The

symbol appears with E-b:

The power is not enough to do a test. You must change the

batteries immediately.

Replacing the Battery To replace the batteries, make sure the meter is turned off.
1. Press the edge of the battery cover and lift it up to remove. 2. Remove the old batteries and replace with four 1.5V AA size alkaline batteries. 3. Close the battery cover.
NOTE · Replacing the batteries does not affect the test results stored in memory. · As with all small batteries, these batteries should be kept away from small
children. If swallowed, promptly seek medical assistance. · Batteries might leak chemicals if unused for a long time. Remove the batteries
if you are not going to use the device for an extended period (i.e., 3 months or more). · Properly dispose of the batteries according to your local environmental regulations.
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USING AC ADAPTER (optional)
Connect AC adapter to the meter. 1. Connect AC adapter plug to DC adapter jack of the meter.
2. Plug AC adapter power plug into an electrical outlet. Press to start the measurement.
Remove AC adapter from the meter. 1. When the meter is off, remove AC adapter power plug from the electrical outlet.
2. Disconnect AC adapter plug from DC adapter jack of the meter.
CARING FOR YOUR METER
To avoid the meter attracting dirt, dust or other contaminants, wash and dry your hands thoroughly before use.
16

Cleaning
· To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth. Do NOT flush with water.
· Do NOT use organic solvents to clean the meter. · Do NOT wash the pressure cuff. · Do NOT iron the pressure cuff.
Meter Storage
· Storage condition: -25°C to 70°C (-13°F to 158°F), 10% to 95% relative humidity. · Always store or transport the meter in its original storage case. · Avoid dropping or heavy impact. · Avoid direct sunlight and high humidity.

DETAILED INFORMATION

REFERENCE VALUES
Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous ageing of the blood vessels. Further causes include diabetes, lack of exercise and cholesterol (LDL) adhering to the blood vessels. Rising blood pressure accelerates hardening of the arteries, and the body becomes more susceptible to apoplexy and coronary infarction.
Definitions and Classification of blood pressure levels according to 2018 ESC/ESH Guidelines for the management of arterial hypertension:

Category

Systolic (mmHg)

Diastolic (mmHg)

Optimal

< 120

and

< 80

Normal

120­129

and/or

80­84

High normal Grade 1 hypertension

130­139 140­159

and/or and/or

85­89 90­99

Grade 2 hypertension
Grade 3 hypertension
Isolated systolic hypertension

160­179 180 140

and/or and/or
and

100­109 110 < 90

Isolated systolic hypertension should be graded (1, 2, 3) according to systolic

blood pressure values in the ranges indicated, provided that diastolic values are

<90mmHg.

17

Source: The European Society of Hypertension and European Society of Cardiology Task Force Members. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Journal of Hypertension: October 2018 – Volume 36 – Issue 10 – p 1953­2041.

SYSTEM TROUBLESHOOTING

If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair by yourself and never try to disassemble the meter under any circumstances.

ERROR MESSAGES

MESSAGE

CAUSE

Inflation or pressure error.

WHAT TO DO
Please contact local customer service for help.

Blood pressure measurement error.

Refit cuff tightly and correctly. Relax and repeat the measurement. If error still remains, contact local customer service for help.

Appears when the cuff deflates too slow.

Please contact local customer service for help.

Appears when the cuff deflates too fast.

Problems with the meter.

Review the instructions and repeat the test. If the meter still does not work, please contact the local customer service for help.

18

Batteries are too low.

Repeat with new batteries or input AC adapter.

Bluetooth transmission errors. Please contact local customer service for help.

Appears when systolic or diastolic blood pressure value is above the pre-set range.

Review the instructions and repeat the test. If error still remains, contact local customer service for help.

Appears when systolic or diastolic blood pressure value is below the pre-set range.

TROUBLESHOOTING
1. If no display appears after pressing POSSIBLE CAUSE
Batteries exhausted.
Batteries incorrectly installed or absent.

. WHAT TO DO
Replace the batteries.
Check that the batteries are correctly installed.

2. If the heart rate is higher/lower than user’s average:

POSSIBLE CAUSE

WHAT TO DO

Movement during measurement.

Repeat measurement.

Measurement taken just after exercise.

Rest at least 30 minutes before repeating measurement.

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3. If the result is higher/lower than user’s average measurement:

POSSIBLE CAUSE

WHAT TO DO

May not be in correct position while measuring.

Adjust to the correct position to measure.

Blood pressure naturally varies from Keep in mind for next measurement. time to time.

4. If the cuff inflates again while measuring: POSSIBLE CAUSE

WHAT TO DO

Cuff is not fastened.

Fasten the cuff again.

If user’s blood pressure is higher than the pressure the device has inflated, the device will automatically increase the pressure and start to inflate again. Stay relaxed and wait for the measurement.

SYMBOL INFORMATION

Symbol

Referent

Manufacturer

Serial number

Symbol

Referent

Type BF applied part

Resistant to liquid ingress

Temperature limit

Humidity limitation

0123 CE mark
Caution
Authorized representative in the European Community
Refer to instruction manual / booklet NOTE On ME EQUIPMENT “Follow instructions for use”

RoHS Compliance
This device does not belong to household waste and must be returned to a collection point for recycling electric and electronic devices according to local laws. If it contains batteries, the batteries should be removed and disposed in accordance with local regulations for separate collection of spent batteries.

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SPECIFICATIONS
SYSTEM PERFORMANCE
Model no.: TD-3128 Power Source: Four 1.5V AA alkaline batteries Battery Life: 200 times Size of Meter w/o Cuff: 141 (L) x 121 (W) x 72 (H)mm, 350g without batteries Cuff Size: S (small) 15 ­ 24cm (5.9 ­ 9.4 inches) with air tube 80 cm
W (Wide size) 24 ­ 43 cm (9.4 ­ 16.9 inches) with air tube 80 cm Memory: Maximum 400 memory records External Output: Bluetooth (ri-champion® smartPRO+ only) (Frequency:2.45GHz, Bandwidth:170MHZ, Modulation:GFSK, ERP:3.54 dBm) Power Saving: Automatic power off if system idle for 3 minutes Operating Conditions: 5°C to 40°C (41°F to 104°F), 15% to 93% relative humidity, 700 hPa to 1060 hPa Storage / Transportation Conditions: -25°C to 70°C (-13°F to 158°F), 10% to 95% relative humidity Power Supply Input: DC + 6V / 1A (max) via Power Plug IP Classification: IP21 Expected Service Life: 3 years
BLOOD PRESSURE MEASUREMENT PERFORMANCE
Heart Rate Range: 40 ­ 199 beat per minute Systolic Measurement Range: 60 mmHg ­ 255 mmHg Diastolic Measurement Range: 30 mmHg ­ 195 mmHg Pulse Rate Measurement Range: 40 ­ 199 beats / minute Maximum Inflation Pressure: 280 mmHg Accuracy of Pressure: ±3 mmHg or ±2% of reading Accuracy of Pulse rate: ±4% of reading Measurement Unit: Either mmHg or KPa This device has been tested to meet the electrical and safety requirements of: IEC/ EN 60601-1, IEC/EN 60601-1-2, EN 301 489-17, EN 301 489-1, EN 300 328. Reference to Standards: · EN 1060-3, NIBP-requirements · IEC60601-1 General requirement for safety · IEC60601-1-2 Requirements for EMC · EN1060-4, NIBP clinical investigation · AAMI / ANSI / IEC 80601-2-30, ANSI/AAMI/ISO 81060-2, NIBP requirements
21

Manufacturer’s declaration-electromagnetic immunity

The TD-3128 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3128 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environmentguidance (for home and professional healthcare environment)

Electrostatic discharge (ESD) IEC 61000-4-2

Contact: ±8 kV Air±2 kV, ±4 kV, ±8 kV, ±15 kV

Contact: ±8 kV Air±2 kV, ±4 kV, ±8 kV, ±15 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2kV for power supply lines ± 1kV for input/ output lines

± 2kV for power supply lines
Not applicable

Mains power quality should be that of a typical home healthcare environment.

Surge IEC 61000-4-5
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

± 0.5kV, ±1kV line(s) to line(s) ± 0.5kV, ±1kV, ±2kV line(s) to earth
Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles
Voltage interruptions: 0 % UT; 250/300 cycle

Power frequency (50, 60 Hz) magnetic field IEC 610004-8

30 A/m 50 Hz or 60 Hz

± 0.5kV, ±1kV line(s) to line(s) Not applicable

Mains power quality should be that of a typical home healthcare environment.

Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25 cycles
Voltage interruptions: 0 % UT; 250 cycle
30 A/m 50 Hz

Mains power quality should be that of a typical home healthcare environment. If the user of the TD3128 requires continued operation during power mains interruptions, it is recommended that the TD-3128 be powered from an uninterruptible power supply or a battery.
The TD-3128 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

22

Manufacturer’s declaration-electromagnetic emissions

The TD-3128 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3128 should assure that it is used in such an environment.

Emission test Compliance

Electromagnetic environment-guidance (for home and professional healthcare environment)

RF emissions CISPR 11

Group 1

The TD-3128 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.

RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2

Class B Class A

The TD-3128 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

Compliance

Manufacturer’s declaration-electromagnetic immunity

The TD-3128 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3128 should assure that it is used in such and environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environmentguidance (for home and professional healthcare environment)

23

Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3

3 Vrms: 0,15 MHz ­ 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz

3 Vrms: 0,15 MHz ­ 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz

80 % AM at 1 kHz
10 V/m 80 MHz ­ 2,7 GHz 80 % AM at 1 kHz

80 % AM at 1 kHz
10 V/m 80 MHz ­ 2,7 GHz 80 % AM at 1 kHz

Portable and mobile RF communications equipment should be used no closer to any part of the TD3128 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2,7 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).
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 TD-3128 is used exceeds the applicable RF compliance level above, the TD-3128 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TD-3128. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

24

Recommended separation distance between portable and mobile RF communications equipment and the TD-3128

The TD-3128 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the TD-3128 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TD-3128 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 80 MHz to 800 MHz 800 MHz to 2,7 GHz

d =1,2P

d =1,2P

d =2,3P

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 meters (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 80 MHz and 800 MHz, 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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