Andon Health 557BT Blood Pressure Monitor User Manual KD 557BT

Andon Health Co., Ltd Blood Pressure Monitor KD 557BT

User Manual

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iHealth®
Wireless Blood Pressure Monitor (KD-557BT)
OWNER’S MANUAL
Table of Contents
INTRODUCTION ................................................................................................................. 1
PACKAGE CONTENTS ...................................................................................................... 1
INTENDED USE .................................................................................................................. 1
CONTRAINDICATION......................................................................................................... 1
PARTS AND DISPLAY INDICATORS ................................................................................ 2
SET UP REQUIREMENTS .................................................................................................. 2
SET UP PROCEDURES...................................................................................................... 3
BATTERY LOADING .......................................................................................................... 3
MEASUREMENT PROCEDURES ...................................................................................... 4
TAKING YOUR BLOOD PRESSURE READING ................................................................ 5
DISPLAYING STORED RESULTS ..................................................................................... 6
DELETING MEASUREMENTS FROM THE MEMORY....................................................... 6
SPECIFICATIONS ............................................................................................................... 7
GENERAL SAFETY AND PRECAUTIONS ........................................................................ 8
TROUBLESHOOTING ........................................................................................................ 9
CARE AND MAINTENANCE ............................................................................................ 11
WARRANTY INFORMATION............................................................................................ 11
EXPLANATION OF SYMBOLS ........................................................................................ 12
CONTACT AND CUSTOMER SERVICE .......................................................................... 13
IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................. 13
OTHER STANDARDS AND COMPLIANCES ................................................................... 14
ELECTROMAGNETIC COMPATIBILITY INFORMATION................................................ 16
INTRODUCTION
Thank you for selecting the iHealth Wireless Blood Pressure Monitor. The iHealth Wireless
Blood Pressure Monitor is a fully automatic arm cuff blood pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works
with your mobile device or is alone to test, track and share vital blood pressure data.
PACKAGE CONTENTS




1 iHealth Wireless Blood Pressure Monitor
1 Owner’s Manual
1 Travel Bag
1 Arm Cuff
INTENDED USE
The iHealth Wireless Blood Pressure Monitor (Electronic Sphygmomanometer) is intended
for use in a professional setting or at home and is a non-invasive blood pressure
measurement system. It is designed to measure the systolic and diastolic blood pressures
and pulse rate of an adult individual by using a technique in which an inflatable cuff is
wrapped around the upper arm. The measurement range of the standard cuff
circumference is 8 21/32”~11 13/16”(22cm~30cm).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this Wireless Blood
Pressure Monitor.
第 1 页 共 16 页
PARTS AND DISPLAY INDICATORS
Memory
Systolic Pressure
Blood Pressure
Level Classification
Irregular Heartbeat
Diastolic
Pressure/
Pulse Rate
Low Battery
Ready to inflate
LCD
Cuf
START
MEM button
SET UP REQUIREMENTS
The iHealth Wireless Blood Pressure Monitor is designed to be used with the following
iPod touch, iPhone and iPad models:
iPhone 4+
iPad mini +
iPad Air
iPad 2+
iPod touch (5th generation)+
The iOS version of these devices should be V6.0 or higher.
The iHealth Wireless Blood Pressure Monitor is also compatible with a number of Android
devices, the Android version should be V4.0 or higher, and RAM should be 1.0G or more.
For a complete list of compatible devices, please visit the support page on
www.ihealthlabs.com
第 2 页 共 16 页
SET UP PROCEDURES
Download the Free iHealth MyVitals App
For iOS device: Prior to first use, download and install “iHealth MyVitals” from the App
Store.
For Android device: Prior to first use, download and install “iHealth MyVitals” from the
Google Play.
Follow the on-screen instructions to register and set up your personal account.
Access the iHealth Cloud Account
Your iHealth account also gives you access to the free and secure iHealth cloud service.
Go to www.ihealthlabs.com and click “Sign In” for access once your account has been
created.
BATTERY LOADING
a. Open battery cover at the back of the monitor.
b. Load four “AA” size batteries. Please pay attention to polarity.
c. Close the battery cover.
When LCD shows battery symbol , replace all batteries with new ones.
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of
battery leakage.
Avoid the battery fluid to get in your eyes. If it should get in your eyes, immediately rinse with
plenty of clean water and contact a physician.
The monitor, the batteries and the cuff, must be disposed of according to local regulations at
the end of their usage.
Connect to iOS Device via Bluetooth
 Apply the cuff and press the START button to test.
 Turn Bluetooth "On" under the "Settings" menu on the iOS device.
 Wait until the model name printed on the monitor, (i.e. "KD-557BT xxxxxx") and "Not Paired" appear
in the Bluetooth menu, and select the model name "KD-557BT
xxxxxx" to pair and connect. The Bluetooth indicator will remain steady
upon successful connection. When using the monitor for the first time,
it may take up to 30 seconds for your iOS device to detect the Bluetooth
signal.

Each subsequent time you use the monitor, "Not Connected" will be displayed
next to "KD-557BT xxxxxx" in the Bluetooth Menu.


Launch the “iHealth MyVitals” app to start using your monitor.
Please repeat these steps when you switch to another iOS device with the
Monitor.
第 3 页 共 16 页
Connect to Android Device via Bluetooth
 Apply the cuff and press the START button to test.
 In the setting menu, turn the Bluetooth on.
 When using the monitor for the first time, you should pair the monitor
to the Android device. Wait until the model name printed on the monitor,
(i.e. "KD-557BT xxxxxx") appears in the Bluetooth menu, and select the model
name "KD-557BT xxxxxx" to pair. it may take up to 30 seconds for your Android
device to detect the Bluetooth signal.


Launch the “iHealth MyVitals” app to start using your monitor.
Please repeat these steps when you switch to another Android device with
the monitor.
MEASUREMENT PROCEDURES
Blood pressure can be affected by the position of the cuff and your physiologic condition. It
is very important that the cuff is positioned at your heart level during blood pressure
measurements.
Body Posture
Sitting Comfortably During Measurement
a. Sit with your feet flat on the floor without crossing your
legs.
b. Place your hand palm-side up in front of you on a flat surface
such as a desk or a table
c. The center of the cuff should be at your heart level.
Lying Down During Measurement
a. Lie on your back.
b. Place your arm straight along your side with your hand palm-side
up.
c. The cuff should be level with your heart.
Note: Blood pressure can be affected by the position of the cuff and your
physiologic condition, so it is important that you always measure your blood
pressure in the same position.
Apply the Cuff
a. Pulling the cuff end through the medal loop (the cuff is packaged like this already), turn it outward (away
from your body) and tighten it and close the Velcro fastener.
b. Place the cuff around a bare arm 1-2cm above the elbow joint.
c. While seated, place palm upside in front of you on a flat surface such as a desk or table. Position the air
tube in the middle of your arm in line with your middle finger.
d. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger
between your arm and the cuff.
第 4 页 共 16 页
Note:
a.Please refer to the cuff circumference range in “SPECIFICATIONS” to make sure that the
appropriate cuff is used.
b.Measure on the same arm each time.
c.Do not move your arm, body, or the monitor and do not move the rubber tube during measurement.
d.Stay still, calm for 5 minutes before blood pressure measurement.
e.Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clear it by hand
in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it.
Clean the cuff after the usage of every 200 times is recommended.
TAKING YOUR BLOOD PRESSURE READING
a. Press the START button to start off-line measurement when disconnected with iOS device. If
connected with iOS device.your monitor can be controlled by ios device
b. A beep is heard and all display characters are shown for self-test. See picture 6. Please contact
the service center if segment is missing.
Picture 6
c.
Picture 6-1
Picture 6-2
Then the current memory bank (U1 or U2) is blinking. See picture 6-1. Press “MEM” button to
change over to other bank. See picture 6-2. Confirm your selection by pressing “START” button.
The current bank can also be confirmed automatically after 5 seconds with no operation.
d. After selecting the memory bank, the monitor starts to seek zero pressure. See picture 6-3.
Picture 6-3
Picture 6-4
Picture 6-5
e. The monitor inflates the cuff until sufficient pressure has built up for a measurement. Then the
monitor slowly releases air from the cuff and carries out the measurement. Finally the blood
pressure and pulse rate will be calculated and displayed on the LCD screen separately. Irregular
heartbeat symbol (if any) will blink. See picture 6-4&6-5. The result will be automatically stored in
the current memory bank.
f.
After measurement, the monitor will turn off automatically after 1 minute of no operation.
Alternatively, you can press the “START” button to turn off the monitor manually or control your
monitor to test again by your app.
g. During measurement, you can press the “START” button to turn off the monitor manually.
Note: Please consult a health care professional for interpretation of pressure measurements.
第 5 页 共 16 页
DISPLAYING STORED RESULTS
a. After the measurement, you can review the measurements in the current memory bank by pressing
button “MEM”.
b. Press “START” button to change over to other bank. See picture 7. Confirm your selection by
pressing “MEM” button. The current bank can also be confirmed automatically after 3 seconds with
no operation.
Picture 7
Picture 7-1
Picture 7-2
picture 7-3
c. After selecting the memory bank, the LCD will display the most recent result in this bank, See picture
7-1 &7-2. If no result stored, LCD will show dashes as picture 7-3.
d. Followed by, the blood pressure and pulse rate will be shown separately. Irregular heartbeat symbol
(if any) will blink. Press “MEM” button again to review the next result. In this way, repeatedly
pressing the “MEM” button displays the respective results measured previously.
e. When displaying the stored results, the monitor will turn off automatically after 1 minute of no
operation. You can also press the button “START” to turn off the monitor manually.
DELETING MEASUREMENTS FROM THE MEMORY
When any result is displaying, keeping on pressing button “MEM” for three seconds, all results in the
current memory bank will be deleted after three “beep”. LCD will show picture 8, Press the button “MEM”
or “START”, the monitor will turn off.
Picture 8
Remember to:
1.Make sure that the appropriate cuff size is used;
refer to the cuff circumference range in the
Specifications section of this manual.
2. Stay still during measurement. Do not move your arm, body or the monitor.
3. Stay still and calm for one to one and half minutes before taking a blood pressure measurement.
Prolonged over-inflation of the bladder may cause bruises of your arm.
4. Keep the cuff clean. Cleaning the cuff after every 200 measurements
is recommended.If the cuff becomes dirty, clean it with a moistened
cloth. Do not rinse the monitor or cuff with running water.
Press the “START” button at any time to turn off the monitor.
Note: Physical activity, eating, drinking, smoking, excitement, stress, and many other
factors influence blood pressure results.
第 6 页 共 16 页
Auto Connect Option
The auto connect option allows the monitor to find the last used iOS device and
re-establish the connection automatically. The auto connect option can be enabled in the
App.
Taking Measurements with Multiple iOS Devices
Turn off the Bluetooth of the last used iOS device if the Auto Connect option is enabled in
your App, then follow the Set Up Instructions in the Quick Start Guide.
Measuring Without an iOS Device
Enable the Offline Measurement function on the App. Apply the cuff, follow the
“Measurement Procedures”, and then press the “START” button to begin measurement. All
offline measurements will be uploaded to the App automatically upon the next successful
Bluetooth connection.
For answers to frequently asked questions, please visit www.ihealthlabs.com
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: KD-557BT
3. Classification: Internally powered, Type BF applied part,IPX0,No AP or APG,
Continuous operation
4. Machine size: 136 mm ×100 mm × 65mm(5 11/32” x 3 15/16” x 2 9/16”)
5. Cuff circumference: 22cm~30cm(8 21/32”~11 13/16”)
6. Weight: about 236g (8 5/16 oz.) (exclude batteries and cuff)
7. Measuring method: oscillometric method, automatic air inflation and measurement
8. Memory volume: 2x60 times with time and date stamp
9. Power source: batteries: 4 ×1.5V SIZE AA
10. Measurement range:
Cuff pressure: 0-300mmHg
Systolic:
60-260mmHg
Diastolic:
40-199mmHg
Pulse rate:
40-180 beats/minute
11. Accuracy:
Pressure: ±3mmHg
Pulse rate: ±5%
12.Environmental temperature for operation: 10℃~40℃(50℉~104℉)
13.Environmental humidity for operation: 15%~85% RH
14.Environmental temperature for storage and transport: -20℃~55℃(-4℉~131℉)
15.Environmental humidity for storage and transport: ≤90% RH
16.Environmental pressure: 80kPa-105kPa
17.Battery life: Approx.360 times.
18.All components belonging to the pressure measuring system, including accessories:
Pump,Valve, LCD, Cuff, Sensor
第 7 页 共 16 页
Note: These specifications are subject to change without notice.
GENERAL SAFETY AND PRECAUTIONS
1. Read all of the information in the Owner’s Manual and other provided instructions before
operating the unit.
2. Consult your physician for any of the following situations:
a)The application of the cuff over a wound or inflamed area.
b)The application of the cuff on any limb with intravascular access
or therapy, or an arterio-venous (A-V) shunt.
c)The application of the cuff on the arm on the side of a mastectomy.
d)Simultaneous use with other medical monitoring equipment on the
same limb.
e)The blood circulation of the user needs to be checked.
3. Do not use this product in a moving vehicle as this may result in inaccurate
measurements.
4. Blood pressure measurements determined by this product are equivalent to those
obtained by professional healthcare practitioners using the cuff/stethoscope auscultation
method within the limits prescribed by the American National Standard, Electronic or
Automated Sphygmomanometer. This device is also clinically validated according to the
2010 Protocol of the European Society of Hypertension(ESH 2010).
5. If you are using a smart phone to operate the device and a phone call comes in during
the measurement, the measurement process will be terminated automatically. It is thus
recommended that the phone be set in Airplane mode during measurement to avoid
interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB
symbol will be displayed. Under this condition, the Wireless Blood Pressure Monitor can
keep functioning, but the results may be inaccurate. Please consult your physician for
accurate assessment.
The IHB symbol will be displayed under 2 sets of circumstances:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period is ≥0.14s and more than
53 percent of the total number of pulses readings falls within
this definition.
7. Please do not use any cuff other than that supplied by the manufacturer as this may
result in inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the
blood pressure monitor and other devices together with advice regarding avoidance of
such interference,please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It
is suggested that the blood pressure monitor should be operated at least 10 metres away
from electric or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside
the rated range specified in part SPECIFICATIONS, the app will
immediately display a technical alarm on the screen. In this case,
repeat the measurement ensuring that the proper measurement
procedures are followed and/or consult with your medical
第 8 页 共 16 页
professional.The technical alarm is preset in the factory and cannot
be adjusted or inactivated. This technical alarm is assigned as low
priority according to IEC 60601-1-8. The technical alarm does not
need to be reset.
This Wireless Blood Pressure Monitor is designed for adults and
should never be used on infants, young children, pregnant or
pre-eclamptic patients. Consult your physician before use on
Children.
This product might not meet its performance specifications if stored
or used outside the specified temperature and humidity ranges.
Please do not share the cuff with any infectious person to avoid
cross-infection.
TROUBLESHOOTING
PROBLEM
POSSIBLE CAUSE
LCD shows low battery symbol
SOLUTION
Low Battery
Change the battery
LCD shows “Er 0” or
Pressure system is unstable
APP display reads “ERROR”
before measurement
LCD shows “Er 1”or
Fail to detect systolic pressure
Don’t move and try again.
APP display reads “ERROR”
LCD shows “Er 2”or
Fail to detect diastolic pressure
APP display reads “ERROR”
LCD shows “Er 3”or
Pneumatic system blocked or cuff
APP display reads “ERROR”
is too tight during inflation
Apply the cuff correctly and
LCD shows “Er 4”or
Pneumatic system leakage or
try again
APP display reads “ERROR”
cuff is too loose during inflation
LCD shows “Er 5””or
Cuff pressure above 300mmHg
APP display reads “ERROR”
Measure again after five
LCD shows “Er 6””or
More than 3 minutes with cuff
minutes. If the monitor is
APP display reads “ERROR”
pressure above 15 mmHg
still abnormal, please
LCD shows “Er 7””or
EEPROM accessing error
contact the local distributor
or the factory.
APP display reads “ERROR”
LCD shows “Er 8””or
Device parameter checking error
APP display reads “ERROR”
LCD shows “Er A””or
Pressure sensor parameter error
APP display reads “ERROR”
Reset iOS/Android device
and take out batteries for
five minutes, and then
Bluetooth
unsuccessful,
Bluetooth connection unstable
abnormal,
connection
monitor
or
is
strong
electromagnetic interference is
present
reinstall all batteries.. Make
sure the monitor and
iOS/Android device are
away from other electrical
equipment. Please see
GENERAL SAFETY
第 9 页 共 16 页
ANDPRECAUTIONS
No response
Incorrect operation or strong
Take out batteries for five
electromagnetic interference
minutes, and then reinstall
all batteries.
第 10 页 共 16 页
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room
temperature before use.
2. It is recommended that product performance be checked every 2 years or after each
repair. Please contact the iHealth Customer Service Center to do so.
3. No monitor component needs to be maintained by the user. The circuit diagrams,
component part lists, descriptions, calibration instructions, or other information which
will assist the user’s appropriately qualified technical personnel to repair those parts of
the equipment which are designated for repair can be supplied by the iHealth technical
department.
4. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using
water, diluted disinfectant alcohol, or diluted detergent.
5. The monitor can maintain the safety and performance characteristics for a minimum of
10,000 measurements or three years of usage, and the cuff integrity is maintained after
1,000 open-close cycles.
6. It is recommended that if the cuff is used in a hospital or a clinic, it be disinfected twice
a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth
lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
Do not drop this monitor or subject it to strong impact.
Avoid high temperature and direct sunlight. Do not immerse the
monitor in water as this will result in damage to the monitor.
Do not attempt to disassemble this monitor.
Battery replacement should only be performed by a qualified iHealth
technician. To do otherwise will void your warranty and possibly
damage your unit.
Cuff replacement should only be performed by a qualified iHealth
technician. To do otherwise will possibly damage your unit.
WARRANTY INFORMATION
The iHealth Wireless Blood Pressure Monitor is warranted to be free from defects in
materials and workmanship within one year from the date of purchase when used in
accordance with the provided instructions. The warranty extends only to the end user. We
will, at our option, repair
or replace without charge the iHealth Wireless Blood Pressure Monitor covered by the
warranty. Repair or replacement is our only responsibility and your only remedy under the
warranty.
第 11 页 共 16 页
EXPLANATION OF SYMBOLS
Symbol for “TYPE BF APPLIED PARTS” (Cuff only)
Symbol for ”THE OPERATION GUIDE MUST BE READ”
The sign background color: blue The sign graphical symbol:
White
Symbol for “ENVIRONMENTAL PROTECTION – Electrical products should not be
disposed of with household waste. Please recycle at appropriate facilities exist.
Check with your local authority or
retailer for recycling advice”.
Symbol for “KEEP DRY”
Symbol for “WARNING”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
EC
REP
Symbol for “EUROPEAN REPRESENTATIVE”
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”
iHealth is a trademark of iHealth Lab Inc.
“Made for iPod”, “Made for iPhone”, and “Made for iPad” mean that an electronic accessory
has been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has
been certified by the developer to meet Apple performance standards. Apple is not
responsible for the operation of this device or its compliance with safety and regulatory
standards. Please note that the use of this accessory with iPod, iPhone, or iPad may affect
wireless performance. iPad, iPhone, and iPod touch are trademarks of Apple Inc.,
registered in the U.S. and other countries.
第 12 页 共 16 页
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Lab Inc.
iHealth Lab Inc.
719N . Shoreline Blvd.,Mountain View, CA 94043, USA
Tel:+1-855-816-7705 www.ihealthlabs.com
EC
REP
iHealthlabs Europe
3 Rue Tronchet,75008,Paris,France
Tel:+33-144-940-488 www.ihealthlabs.com
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China
Tel: 86-22-60526161
IMPORTANT INFORMATION REQUIRED BY THE FCC
This device complies with Part 15 of the FCC Rules. Its operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
Changes or modifications not expressly approved by iHealth Lab Inc.
would void the user’s authority to operate the product.
Note: This product 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 product
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 product 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 or more 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 product complies with Industry Canada. IC: RSS-210
IC NOTICE
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference
that may cause undesired operation of the device.
This product is approved in accordance to R&TTE directive transmitter.
第 13 页 共 16 页
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:
IEC 60601-1:2005+C1:2006+C2:2007(Medical electrical equipment – Part 1: General
requirements for safety);
IEC 60601-1-2:2007 (Medical electrical equipment – Part 1: General requirements for
safety; Collateral Standard-Electromagnetic compatibility - Requirements and tests);
EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1:
General requirements);
EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring systems);
AAMI/ANSI 80601-2-30:2009/IEC 80601-2-30:2009+Cor.2010/EN
80601-2-30:2010(Medical electrical equipment –Part 2-30: Particular requirements for the
basic safety and essential performance of automated non-invasive sphygmomanometers).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The KD-557BT is intended for use in the electromagnetic environment specified below.
The customer or the user of the KD-557BT should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
The KD-557BT uses RF energy only for its internal
RF emissions
function. Therefore, its RF emissions are very low and are
Group 1
CISPR 11
not likely to cause any interference in nearby electronic
equipment.
RF emissions
The KD-557BT is suitable for use in all establishments
Class B
CISPR 11
Harmonic emissions
other than domestic and those directly connected to the
Not applicable
IEC 61000-3-2
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions
Not applicable
IEC 61000-3-3
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or
the user of the KD-557BT should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance level
Electromagnetic environment
- guidance
Electrostatic
± 6 kV contact
± 6 kV contact
Floors should be wood, concrete
discharge (ESD)
± 8 kV air
± 8 kV air
or ceramic tile. If floors are
IEC 61000-4-2
covered with synthetic material,
the relative humidity should be
at least 30 %.
Power frequency
3 A/m
3 A/m
Power frequency magnetic fields
(50/60 Hz)
should be at levels characteristic
magnetic field
of a typical location in a typical
第 14 页 共 16 页
IEC 61000-4-8
commercial or hospital
environment.
Table 3
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or
the user of the KD-557BT should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance
Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the KD-557BT, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
Radiated RF
3 V/m 80 MHz to 2.5
IEC 61000-4-3
GHz
d  1 .2 P
80 MHz to 800 MHz
3 V/m
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 meters
(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
KD-557BT is used exceeds the applicable RF compliance level above, the KD-557BT should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
第 15 页 共 16 页
such as re-orienting or relocating the KD-557BT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the KD-557BT
The KD-557BT is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the KD-557BT can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the KD-557BT as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
Separation distance according to frequency of transmitter
output
power of
transmitter
150 kHz to 80 MHz
d  1 .2 P
80 MHz to 800 MHz
d  1 .2 P
800 MHz to 2,5 GHz
d  2 .3 P
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1.2
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 determined 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.
第 16 页 共 16 页

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