Biolight Meditech WBP202 User Manual

Electronic Sphygmomanometer

User’s Manual

Guangdong Biolight Meditech Co., Ltd.

Product Information

 Product Model: WBP100/WBP201/WBP202

 Product Name: Electronic Sphygmomanometer
 Manufacturer Name: Guangdong Biolight Meditech Co.,Ltd.
 After Service Contact Information:

Address: No.2 Innovation First Road, Technical Innovation Coast,

Hi-tech Zone, Zhuhai, P.R. China
Fax: [phone]
Post code: 519085
Toll-free consultation hot line: [phone]

 Service life：5 years

Revision History

This manual has a revision number. This revision number changes
whenever the manual is updated due to software or technical specification
change. Contents of this manual are subject to change without prior notice.

 Document No.: J/WBPCE-A-008
 Revision number: V1.0
 Release time: Sept. 2015

Copyright © 2015 Guangdong Biolight Meditech Co., Ltd. All rights
reserved.

CE mark

EC Representative Name:

Shanghai International Holding Corp. GmbH (Europe)

EC Representative Address:

Eiffestrasse 80, 20537 Hamburg Germany

Statement

Manufacturer holds the copyright of this manual, and we are also entitled
to deal with this manual as confidential files. This manual is only used for
operation, maintenance and service of product, someone else can not publish
the manual.

This manual contains exclusive information protected by copyright laws
and we reserve its copyright. Without written approval of manufacturer no
parts of this manual shall be photocopied, Xeroxed or translated into other
languages.

The contents contained in this manual are subject to amendments without

notification.

Manufacturer's Responsibility

Only under the following circumstances will manufacturer be responsible

for the safety, reliability and performance of the instrument:
 All the installation, expansion, readjustment, renovation or repairs are

conducted by the personnel certified by manufacturer.

 The storage condition, operation condition and electrical status of the

instrument conform to the product specification.

 The instrument is used in accordance with the user’s manual.

About this manual

This manual contains the instructions necessary to operate the product
safely and in accordance with its function and intended use. Observance of
this manual is a prerequisite for proper product performance and correct
operation.
This manual is based on the maximum configuration and therefore some
contents may not apply to your product. If you have any question, please
contact us.
This manual is an integral part of the product. It should always be kept
close to the equipment so that it can be obtained conveniently when needed.

Illustrations are for reference only. They may be not in conformity with





your products.

Signs in this manual：

Warning: Indicates a potential hazard or unsafe practice that, if

not avoided, will result in death or serious injury.

Caution: Indicates a potential hazard or unsafe practice that, if not
avoided, could result in minor personal injury or product/property
damage.

Note: Provides application tips or other useful information to ensure

that you get the most from your product.

Electronic Sphygmomanometer User’s manual

Contents

1、 Intended Use ......................................................................................................................... 1

2、 Application ............................................................................................................................ 1

3、 Safety Information ................................................................................................................ 1

4、 Appearance ........................................................................................................................... 4

5、 Display .................................................................................................................................. 6

6、 Setting ................................................................................................................................... 7

7、 Historical data review function ............................................................................................. 8

8、 Download And Install The Software ..................................................................................... 8

9、 Using Steps ........................................................................................................................... 8

10、 Maintenance and Cleaning .............................................................................................. 11

11、 Accessory and Specifications .............................................................................................. 12

12、 Troubleshooting .............................................................................................................. 14

13、 Equipment Symbols ........................................................................................................ 15

14、 Blood pressure general knowledge ................................................................................. 15

Appendix A Guidance and Manufacturer’s Declaration of EMC ................................................... 17

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Electronic Sphygmomanometer User’s manual



1、 Intended Use

The device is intended to measure blood pressure and pulse rate of adult. The
measurement data is available for clinical reference. It can store, manage the measure
data, and transmit the measuring result via wireless signal.

It is intended to be used in clinic, general ward, physical examination department
and at home.

Caution:

 The patient is the operator when the device is used at home or in public

areas;

 The device is intended for use only by clinical professionals and in continual

attendance when it’s used in hospital.

2、 Application

The device is reusable and intended for measuring human blood pressure and

pulse rate.

 Application population

Adult.

 Measurement site

Place a bare arm through the cuff and position the cuff 1-2cm above the elbow
joint.

3、 Safety Information

Warning：

 Don’t take measurement immediately after smoking, drinking alcohol, coffee

and black tea, or within an hour after a meal;

 Magnetic and electrical fields are capable of interfering with the proper

performance of the device. For this reason make sure that all external
equipments operated in the vicinity of the device comply with the relevant
EMC requirements. Mobile phone, X-ray equipment or MRI devices are a
possible source of interference as they may emit higher levels of
electromagnetic radiation;

 The device is designed for adults and should never be used on infants,

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Electronic Sphygmomanometer User’s manual

pregnant, pre-eclampic patients or people with serious arrhythmia. Consult
your physician before use on children;

 Don’t use the electronic sphygmomanometer in the environment containing

inflammable anesthetic gas;

 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 side of a mastectomy;
d) Simultaneous use with other medical monitoring equipment on the same

limb;
 The device cannot be used together with high-frequency electrotomes and

defibrillators;

 Please do not use the device while it is charging;
 Please do not measure immediately after an intense movement or a bath;
 This product might not meet its performance specifications if stored or used

outside the specified temperature, humidity and altitude ranges;

 Please do not share the cuff with any infectious person to avoid

cross-infection;

 Battery replacement should only be performed by personnel who have been

confirmed qualified by the manufacturer. To do otherwise will void your
warranty and possible damage your unit;

 Any form of modification to this device is forbidden.

Caution：

 Make sure that the appropriate cuff size is used;
 Cuff is replaceable and its replacement can only be conducted by

manufacturer.

 We recommend the users to use the original manufactured cuff and adapter.

If not, it might cause measurement error or product failure;

 If the adapter is abnormal, please change the adapter;
 Too high cuff pressure or too long charging time may make users feel

uncomfortable, and cause ischemia and neuropathy. Please turn off the
device in time and take off the cuff;

 The device and adapter should be considered as a medical system. The power

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Electronic Sphygmomanometer User’s manual

adapter must be provided or designated by manufacturer (see optional item
list). If use another power adapter, it should be verified, otherwise electric
shock may occur and cause patient death;

 The effective wireless transmission distance is 5m in a barrier-free

environment. If more than this distance, the product might not work. Please
use this product within effective wireless transmission distance;

 The charging cable should be put beyond children to avoid the danger of

strangulation;

 If children or pets beat, throw or tramp on the device, it might affect the

performance of the device. Please put the device beyond children and pets;

 The main unit, cable, battery and cuff must be disposed according to the

local regulations at the end of their usage.

Caution：

 Changes or modifications not expressly approved by the party responsible

for compliance could void the user’s authority to operate the equipment;

 This equipment has been tested and found to comply with the limits for a

Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a
particular installation;

 If this equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one 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.

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Electronic Sphygmomanometer User’s manual



Note：

 Doctor should make diagnosis on clinical manifestation and symptoms, only

with using the device as subsidiary.

 Blood pressure can be affected by the position of the cuff, measuring posture

and your physiologic condition;

 This device complies with Part 15 of the FCC Rules. 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;

 The device complies with the standard of IEC 80601-2-30;
 If the determined blood pressure (systolic or diastolic) is outside the rated

range specified in part specifications, the device will immediately display an
error code on screen. In this case, consult a physician or ensure that proper
measurement procedures are followed;

 Patients can use all functions of the device safely according to this user’s

manual;

 Any questions about setting, using or maintaining the device, please contact

with manufacturer;

 If unexpected operation or events appear in use process, please report to the

manufacturer;

 When measuring, the following conditions may lead to the measured results

have differences:

a) Talking ; b)After defecate or urinate;
c) After the bath; d) Different measurement site or environment;
e) After smoking; f) After drinking alcohol, coffee and black tea;
g) After the movement; h) Room temperature changes suddenly

i) Within an hour after a meal; j) Mood be agitated when caused by

tension, uneasy.

4、 Appearance

 WBP100：

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Electronic Sphygmomanometer User’s manual

1 3 4 56 4 3 2 1

 WBP201/WBP202：

1、 Cuff

2、 Display screen

Display systolic blood pressure, diastolic blood pressure, pulse rate and so on.

3、 Power button；Start/Stop button

— Long press (press and hold it more than 2s) this button to turn off the
device;

— When the power is off, short press (press and hold it less than 2s) this

button to turn on the device. Otherwise, short press it to start/stop the
NIBP measurement.

4、 Charging cable interface

Connect to the power supply for charging.

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Electronic Sphygmomanometer User’s manual

Error code

Definition

Possible Reason

E02

Self-test failed

Transducer or other hardware failure.

E06

Loose cuff

a. Cuff is completely unwrapped;
b. No cuff attached;

E07

Air leak

Air leak in pneumatics, hose, or cuff.

E08

Air pressure error

Unit cannot maintain stable cuff pressure, e.g. kinked.

E09

Weak signal

a. Very weak patient signal due to a loosely wrapped

cuff;

b. Extremely weak pulse from patient.

10 1 3 4 5

8

7

6 9 2

5、 Select users button

— In measurement sate: Short press this button to select users;
— In setting state: Short press this button, the time value would increase one.

6、 Historical data review button

— Not in setting state: Short press this button to review historical data. Long

press it to enter setting mode.
— In setting state: Short press this button to switch the setting items. Long
press it to save the setting and quit setting mode.

5、 Display

1. Systolic blood pressure;

2. Blood pressure unit;

3. Diastolic blood pressure;

4. Pulse rate;

5. Time;

6. Users name;

7. Pulse rate unit;

8. Signal quality;

9. Bluetooth state;

10. Battery state.

When measuring error, such as transducer failure, loosely wrapped cuff, screen
displays the wrong code. The definition of the error code and the possible reason are
as follows:

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Electronic Sphygmomanometer User’s manual

Error code

Definition

Possible Reason

E10

Range exceeded

Measurement range exceeds module specification of 255
mmHg maximum.

E11

Excessive motion

a. Too many retries due to interference of motion

artifact;

b. Signal is too noisy during step-down to detect

pressure pulse, e.g. subject has severe tremor;

c. Irregular pulse rate, e.g. arrhythmia.

E12

Overpressure sensed

Cuff pressure exceeds software safety limit, 295 mmHg
in Adult mode. Could be due to rapid squeezing or
bumping of cuff.

E13

Signal saturated

Large motion artifact that saturates the BP amplifier’s
amplitude handling capability.

E14

Air system leak

Module report Air system leakage Failure while in the
Air System Leakage Test mode.

E15

System failure

Abnormal events.

E19

Time out

Measurement took more than 120 seconds in adult.

6、 Setting

You can set the time and date of this product. The setting method is as follows:

Press the historical data review button “ ”and hold it for 3 seconds to enter
the year setting interface. The third number of the year starts to flash. When you press
the select users button “ ” once, the third number increase 1 (It means the year
increases ten years).

After you finish setting the third number of year, press the historical data review
button “ ” to enter the setting interface of the fourth number. The fourth number
of the year starts to flash. When you press the select users button “ ” once, the
fourth number increase 1 (It means the year increases 1 year).

Set month, day, hour, and minute in the same way.

After you finish setting time and date, press the historical data review button
“ ” to enter the setting interface of blood pressure units (The default unit is mmHg).
When a flashing mmHg appears on the screen, it means the blood pressure unit is
mmHg. Press the select users button “ ”, mmHg would disappear and kPa would
appear. Press the button “ ” again, kPa would disappear and mmHg would appear.
So repeatedly, you can switch between the two units. Press the historical data review
button “ ” and hold it for 3 seconds to end the setting after you finish setting unit.

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Electronic Sphygmomanometer User’s manual

7、 Historical data review function

This device can record the blood pressure, pulse rate and time automatically to
facilitate the management of blood pressure. Press the historical data review button
“ ”, the latest measurement result would be displayed on the screen. Press the
button “ ” again, the second latest measurement result would be displayed. And
so on, you can review all the historical data.

8、 Download And Install The Software

1、Software download methods：

Users who use the IOS system device can log in iphone App Store, enter “Biolight”

and search for the software of “BP tracker” in the searching results.

Users who use the Android system device can log in the wearcare official website:
http://www.wearcare.cn for download.
2、 Download the software of “BP tracker”, click installation button for free
installation.

9、 Using Steps

 Preparation before measurement

1、Keep your body and mood calm, take off the thicker clothes such as coat,
sweater, Etc. When measuring, bare upper arm or wear thinner shirt.

2、Long press the power button to turn on the device. (Users, who use APP
software, need to open the Bluetooth of the device and terminal, open the APP
software, and connect with the device )

Caution：
 When a call comes in during the measurement, the measurement will be

terminated. It is recommended that IOS device be set in Airplane mode
during measurement to avoid strong magnetism interference.

 Using Steps

(1) Apply the cuff

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Electronic Sphygmomanometer User’s manual

 Loosen the calibre of the curly cuff slightly. Place a bare arm through the cuff

directly according to the instruction icon “ ”, “ ”. Position the
cuff 1-2cm above the elbow joint and ensure the mark “Φ” on the cuff shall
lie above artery.

 Pull one end of the cuff to the lateral and tighten. The cuff should fit

comfortably, yet snugly around your arm. You should be able to insert one
finger between your arm and the cuff.

Caution：

 Make sure that the appropriate cuff size is used. Refer to the cuff

circumference range in the Specification section of this manual.

(2) Body posture

Stay still and calm for five minutes before taking a blood pressure measurement.

Be seated with your feet flat on the floor without crossing your legs. Place your
hand palm-side up in front of you on a flat surface such as a desk or table. The cuff
should be placed at the same level as your heart.

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Electronic Sphygmomanometer User’s manual

Note:

 Incorrect measuring posture showed as follows might cause an incorrect

measurement:

a) Bent over（lean forward）;
b) Sitting cross-legged;
c) Bend the body because of the low table or sitting on sofa.

(3) Measuring

 Select users: Press the Select users button to select users, you can select user

1 or user 2;

 Start measuring: Press the power button, then the cuff pressure automatically

and the screen shows rising pressure values. Stay still and calm during
measurement. Do not move your arm, body and the device.

(4) Display the measurement value

The device exhausts automatically and displays the measurement results. About
the display interface of measurement results, please refer to chapter “5 Display”.

Users, who use the APP software, can read the measurement results on the
software interface.

(5) Take off the cuff
(6) Turn off the device

Long press the power button to turn off the device after the measurement.

Note:

 While measuring blood pressure, the users must stay still and calm without

any talk;

 The cuff tied on the limb shall be on the same level as the patient’s heart so

as to avoid the reading error resulting from the hydrostatics effect of the blood
flow between the heart and cuff. If the cuff position is higher than heart level,
the BP reading will be lower, the measured result shall be added 0.75mmHg
(0.1kPa) for each centimeter higher; in case the cuff position is lower than
heart level, the BP reading will be higher, the measured result shall be deducted

0.75mmHg (0.1kPa) for each centimeter lower;

 If the signal measurement time is more than two minutes and the device

doesn’t exhaust automatically, please take off the cuff and turn off the device.

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Electronic Sphygmomanometer User’s manual



Caution：

 You can stop the measurement process at any time by pressing “Start/Stop

button”.

Warning:

 Prolonged and frequent NIBP measurements are associated with ischemia

and neuropathy in the limb wearing the cuff. Please examine the extremities
of the limb frequently for normal color, warmth and sensitivity. If any
abnormality is observed, stop the NIBP measurements.

 Too frequent measurements may have influence on the measurement results.

10、 Maintenance and Cleaning

1、 Clean the traces on the host or display with a dry, soft cloth or tissue;
2、 The most commonly used hospital cleaning agent and non-corrosive detergents

can be used for cleaning the device, but please be careful that many types of
detergents must be diluted before use; Please use them according to the
directions of the manufacturers of the detergents;

3、 The casing of the device should be kept from the contamination of filth and

dirt, and it can be wiped with non-velvet soft cloth. When cleaning, do not
spill the liquid onto the instrument. Ensure no liquid is allowed to enter the
inside of the device;

4、 It is recommended that if the cuff is used, for example, in 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.

5、 Please do not clean or wet cuff. Please do not soak the device in liquid;
6、 Please store the host and the cuff in a cool and dry place;
7、 Do not drop the device or subject it to strong impact.

Caution：

 Avoid using alcohol-based, amido or acetone-based detergents.
 Please put the main unit and its accessories beyond infants and young

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Electronic Sphygmomanometer User’s manual

Items

Mode

Power adapter (optional)

LXCP12-05(Output DC5V,1.0A)

Production model

WBP100、WBP201、WBP202

Size

130 mm(L) x 55 mm(W) x 30 mm(H)

Weight

＜350g

Measure specifications

Measurement way

Automatic oscillometry

Measurement range
Systolic:
Diastolic:

30 mmHg～255 mmHg（4.0kPa～34.0kPa）；
10 mmHg～220 mmHg（1.3kPa～29.3kPa）；

Pressure accuracy

Static:
Clinic:

±3 mmHg
Average error: ±5 mmHg, standard deviation: ≤8 mmHg

PR range and accuracy

40 bpm～240 bpm，±5% or ±3bpm, whichever is the greater

Blood pressure unit

“mmHg” or “kPa”

children to avoid dangerous accident.

 Under normal circumstances, it is unnecessary for the device to have special

maintenance, and cautions must be exercised on the following points during the
use of the device.

——Please use the device in the environment according to the requirements
of the performance criteria;

——Avoid exposure or direct sunlight;
——Avoid excessive radioactive infrared rays or ultraviolet rays;
——Avoid contacts with organic solutions, dusts or corrosive gases.

 No device component needs to be maintained by the user. Electrical

schematic diagram and component list are only provided to repair station or
personnel which have been confirmed qualified by the manufacturer;

 Check the device regularly please. If you doubt the measurement result is

not accurate, please contact the manufacturer.

11、 Accessory and Specifications

11.1 Optional item

11.2 Technical Specifications

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Electronic Sphygmomanometer User’s manual

Software overpressure
protection

295±5 mmHg

Measurement time

Normally, it is 20s to 45s (depending on HR and moving
interference typically)
Maximal measurement time: 120s

LED indicating lamp

WBP 100
Bluetooth

indicating
lamp

1 (Blue)
Not connected: The lamp flashes blue;
Connected: The lamp lights blue without flashing;
(When the device is power off, the lamp is off.)

Charging
indicating
lamp

1 (Orange)
Light up: When the battery is being charged or when the DC
power supply is connected;
Off: When the battery is fully charged.

WBP 201
WBP 202
Bluetooth
state
indicating

Not connected: The indicating flashes;
Connected: The indicating lights without flashing;

Battery
state
indicating

The electric quantity of battery is divided into four ranks to
display the current electricity.
Being Charged : The indicating flashes;
Not being charged or fully charged: The indicating lights
without flashing.

Bluetooth

Bluetooth version

Bluetooth 4.0 with low power consumption.

Transmission frequency

2440 MHz

Wireless transmission
distance

＜5m

App software platform

IOS system

iPhone 4s、iPhone5、iPhone5s、iPhone 6、iPad3+、iPad mini

Android (4.3+) system

Mobile phone, Palmtop computer

Battery

Type

Rechargeable lithium ion battery

Rated voltage

3.7 VDC

Capability

600 mAh

Operating time

≥24 h

Charge time

≤2 h

Cuff

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Electronic Sphygmomanometer User’s manual

Large cuff

32 cm～42cm（Optional）

Medium cuff

22 cm～32cm（With）

Small cuff

17 cm～22cm（Optional）

Adapter

Input

100～240V, 50/60Hz 0.3Amax

Output

DC 5V, 1A

Environment specifications

Temperature

Operating: 5℃～+40℃;
Transportation and storage: -20℃～+55℃.

Humidity

Operating: 25%～95%（non condensing）;
Transportation and storage: 25%～95% (non condensing).

Atmospheric pressure

Operating: 700hPa～1060hPa;
Transportation and storage: 500hPa～1060hPa.

Symptom

Possible Reason

Solution

No response or cannot

turn on the device

1. The battery power might be at

shortage or no electricity;

1、 The device itself might be

damaged.

1、 Please charge the device;
2、 Contact customer service.

The data cannot be
display properly or
display reads an abnormal

result

1. The cuff position was not

correct or it was not properly
tightened;

2. Speaking, moving arm or body,

being angry, excited or nervous
during test.

1. Review the cuff

application instructions
and retest;

2. Retest when calm; avoid

speaking or movement
during the test.

Cannot make connection
between device and
receiver

1. Bluetooth does not be open on

receiver;

2. The version of Android in the

receiver device isn’t 4.3 or 4.3+;

3. The version of Bluetooth is not

4.0;

4. Out of connection range.

1. Open Bluetooth;

2. Upgrade the Android system

to version 4.3 or 4.3+;

3. Use the receiver device with

Bluetooth 4.0;

4. Close to receiver.

12、 Troubleshooting

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Electronic Sphygmomanometer User’s manual

Symbol

Symbol Note

Type BF applied part, without defibrillation protected.
Refer to this user’s manual.

Symbol for the marking of electrical and electronics devices according to
Directive 2002/96/EC

LOT

Batch code

SN

Serial number

IP22

Enclosure degree of ingress protection.

Federal Communications Commission

IPX0

Power adapter

Degree of protection against ingress of liquid

Fragile.
Show transport package contents fragile, so handling should be handled with
care.

Upward.
It shows the correct position of the transport package is upright.

Guard against wet.
Show packages afraid be wet.

Stacking layer limit.
Same packing maximum stacking layers, N represents the number of layers
limit. (N is 6).

13、 Equipment Symbols

14、 Blood pressure general knowledge

14.1 Definition of blood pressure

Blood pressure is the pressure on the vessel wall side. When the heart is
contracting, the blood pressure is the highest at this time and is called the systolic
pressure. When the heart is relaxing, the blood pressure is the lowest at this time and
is called the diastolic blood pressure.

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Electronic Sphygmomanometer User’s manual

Scope

Systolic blood
pressure (SYS)
kPa/mmHg

Diastolic blood
pressure (DIA)
kPa/mmHg

Corresponding
measure

Hypotension

≤13.3/100

≤8.0/60

Ask physician for
measuring.

Normal blood pressure

13.3/100～18.7/140

8.0/60～12.0/90

Self measure.

Mild Hypertension

18.7/140～21.3/160

12.0/90～13.3/100

Consult physician.

Moderate Hypertension

21.3/160～24.0/180

13.3/100～14.7/110

Consult physician.

Severe Hypertension

≥24.0/180

≥14.7/110

Danger! Please see the
doctor as soon as
possible.



14.2 Classification of blood pressure

The World Health Organization (WHO) has created the following blood pressure
classify table for assessing high blood pressure (without regard age or gender). Please
note that other factors (e.g. diabetes, obesity, smoking, etc.) also need to be
considered. Consult with your physician for accurate assessment.

Note：This table is not intended to provide a basis for any type of
emergency condition or diagnosis. This table only depicts different classification
of blood pressure. Consult your physician for proper interpretation of blood
pressure results.

16

Guidance and manufacture’s declaration – electromagnetic emission

The device is intended for use in the electromagnetic environment specified below. The customer
of the user of the device should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment – guidance

RF emissions
CISPR 11

Group 1

The device use 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 emission
CISPR 11

Class B

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.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Complies



Appendix A Guidance and Manufacturer’s
Declaration of EMC

Note：

 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.

 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.

Caution:

 This unit has been thoroughly tested and inspected to assure proper performance and

operation.

 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.

17

Guidance and manufacture’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the
user of device should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment

- guidance

Electrostatic
discharge (ESD)
IEC 61000-4-2

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

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

Electrical fast
transient/burst
IEC 61000-4-4

±2 kV for power
supply lines

±2kV for power
supply lines

Mains power quality should be
that of a typical commercial or
hospital environment.

Surge
IEC 61000-4-5

± 1 kV line(s) to
line(s)

±1 kV differential
mode

Mains power quality should be
that of a typical commercial or
hospital environment.

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

40% UT
(60% dip in UT)
for 5 cycles

70% UT
(30% dip in UT)
for 25 cycles

<5% UT
(>95% dip in UT)
for 5 sec

<5% UT
(>95% dip in UT)
for 0.5 cycle

40% UT
(60% dip in UT)
for 5 cycles

70% UT
(30% dip in UT)
for 25 cycles

<5% UT
(>95% dip in UT)
for 5 sec

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
(50Hz/60Hz)
magnetic field IEC
61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

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

18

Guidance and manufacture’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

IEC 60601

test level

Compliance

level

Electromagnetic environment - guidance

Conducted

RF

IEC

61000-4-6

3 V

rms

150 kHz to 80

MHz

3 Vrms

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

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:

Radiated RF

IEC

61000-4-3

3 V/m

80 MHz to 2.5

GHz

3 V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot
be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

19

Recommended separation distances between

portable and mobile RF communications equipment and the device .

The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum

output power of

transmitter

(W)

Separation distance according to frequency of transmitter

(m)

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

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.

20