Ichoice Ls805-b User manual

Ver 1.0

User’s Manual

Blood Pressure Monitor

Thank&you&very&much&for&selecting&iChoice&Blood&Pressure&Monitor

LS805-B.&

Please do read the user

manual carefully and

thoroughtly so as to ensure the safe usage of this product, and keep the

manual well for further reference in case you have problems.

Arm Type

Contains FCC ID: OU9AW8001-LS

Revised Date: June 18, 2016

Ver 1.0

CATALOGUE

Table of Contents

INTRODUCTION.

.....................................................................................................................................

General Description

Indications for Use

Contraindications

Safety Information

LCD Display Signal

Monitor Components

BEFORE YOU START ............................................................................................................................. 7

The Choice of Power Source

Setting Date, Time and Measurement Unit

Install App and Pair-Up

START MEASUREMENT.............................................................................................................. 11

Apply the Cuff

Start Measurement

DATA MANAGEMENT ..................................................................................................................13

Recall the Records

Delete the Records

Data Transmission

INFORMATION FOR USER.............................................................................................................15

Tips for measurement

Maintenance

ABOUT BLOOD PRESSURE .......................................................................................................17

What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

Why does my blood pressure fluctuate throughout the day?

Why do I get a different blood pressure at home compared to the hospital?

Is the result the same if measuring on the right arm?

TROUBLESHOOTING. ................................................................................................................. 19

SPECIFICATIONS............................................................................................................................. 20

AUTHORIZED COMPONENT ........................................................................................................21

CONTACT INFORMATION................................................................................................................. 21

COMPLIED STANDARDS LIST......................................................................................................21

FCC STATEMENT ................................................................................................................................... 22

EMC GUIDANCE............................................................................................................................22

INTRODUCTION

General Description

Thank you for selecting iChoice Wireless blood pressure monitor.The

monitor features blood pressure measurement, pulse rate measurement and the

result storage. The design provides you with two years of reliable service.

Readings taken by the monitor are equivalent to those obtained by a trained

observer using the cuff and stethoscope auscultation method.

This manual contains important safety and care information, and provides step

by step instructions for using the product.

Read the manual thoroughly before using the product.

Features:

125mm x 47mm Blue LCD display with white backlight

Up to 60 pieces of record stored for each user

Measuring during inflation technology

Indications for Use

1. The iChoice Wireless Blood Pressure Monitor is digital monitors intended

for use in measuring blood pressure and heartbeat rate with arm

circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ) .

2. The monitor detects the appearance of irregular heartbeats during

measurement and gives a warning signal with readings.

3. It is intended for adult use in the home/domestic setting only.

Contraindications

1. The device is contraindicated for any person who is connected to a

wearable or implantable electronic device or instrument such as a

pacemaker or defibrillator.

2. The device is not intended to be a diagnostic device. Contract your

physician if hypertensive values are indicated.

Measurement Principle

This product uses the Oscillometric Measuring method to detect blood pressure.

Before every measurement, the unit establishes a “zero pressure” equivalent to

the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects

pressure oscillations generated by beat-to-beat pulsatile, which is used to determine

the systolic and diastolic pressure, and also pulse rate. The device also compares

the longest and the shortest time intervals of detected pulse waves to mean time

interval then calculates standard deviation. The device will display a warning signal

with the reading to indicate the detection of irregular heartbeat when the difference

of the time intervals over.

Safety Information

The signs below might be in the user manual, labeling or other component.

They are the requirement of standard and using.

Symbol for “THE OPERATION

GUIDE MUST BE READ”

Symbol for “TYPE BF APPLIED

PARTS”

Symbol for “MANUFACTURER”

Symbol for “ENVIRONMENT

PROTECTION – Electrical waste

products should not be disposed of

with household waste. Please follow

local guidelines.”

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE

DATE”

Symbol for “Including RF

transmitter”

Caution: These notes must be

observed to prevent any

damage to the device.

Storage & transportation

condition

Ingress of Protection

IP22

INTRODUCTION

LCD Display Signal

CAUTION

This device is intended for adult use only.

This device is intended for no-invasive measuring and monitoring of arterial blood pressure.

It is not intended for use on extremities other than the arm or for functions other than obtaining a

blood pressure measurement.

Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood

pressure.Do not begin or end medical treatment without asking a physician for treatment advice.

If you are taking medication,consult your physician to determine the most appropriate time to

measure your blood pressure. Never change a prescribed medication without consulting your

Physician.

When the device was used to measure patients who have common arrhythmias such as atrial or

ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please

consult your physician about the result.

If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the

cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and

press the corresponding user button to stop inflation.

The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable

anesthetic mixture with air of with oxygen or nitrous oxide.

The operator shall not touch output of batteries /adapter and the patient simultaneously.

To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated

interference signal or electrical fast transient/burst signal.

The user must check that the equipment functions safely and see that it is in proper working

condition before being used.

This device is contraindicated for any female who may be suspected of, or is pregnant. Besides

providing inaccurate readings, the effects of this device on the fetus are unknown.

Manufacturer will make available on request circuit diagrams, component parts list etc.

This unit is not suitable for continuous monitoring during medical emergencies or operations.

Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to

a lack of blood.

Please use the device under the environment which was provided in the user manual. Otherwise,

the performance and lifetime of the device will be impacted and reduced.

During use, the patient will be in contact with the cuff. The materials of the cuff have been tested

and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not

cause any potential sensization or irritation reaction.

Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.

Otherwise, it may cause damage to the unit or danger to the user/patients.

The device doesn’t need to be calibrated within the two years of reliable service.

Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the

local guidelines.

If you have any problems with this device, such as setting up, maintaining or using, please

contact the SERVICE PERSONNEL of iChoice. Don’t open or repair the device by yourself.

Please report to iChoice if any unexpected operation or events occur.

Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.

4 5

SYMB

DESCRIPTION

EXPLANATION

Systolic Blood Pressure

High blood pressure

Diastolic Blood Pressure

Low blood pressure

Pulse per minute

Beats per minute, BPM

User 1

Start measurement save and transmit

the measuring result for user 1

User 2

Start measurement, save and transmit

the measuring result for user 2

Heartbeat

Heartbeat detection during the measurement

Data Pending to Transmit

Measurement data stored in the

equipment

Data Transmitting

Data is transmitting

Average Value

Average value of last three measurements

Shocking reminder

Shocking will result in inaccurate

Low Battery

Low battery and please replace the batteries

Unit

Measurement unit of blood pressure

(1mmHg=0.133kPa) (1kPa=7.5mmHg)

Current Time

Month/Day (Hour : Minute)

Deflating

Exhaust the air in the cuff

Data Enquiry Mode

Recall the records

Irregular Heartbeat

Irregular Heartbeat Detection

Memory

Display the serial number of

the measurement

Monitor Components

The Choice of Power Supply

Battery powered mode:

6V DC 4×AAA batteries

AC adaptor powered mode:

6V 1A

(Can be supplied by AC adaptor model

UE08WCP-060100SPA !)(Not Included)

DC POWER SOCKET

INQUIRY BUTTON

USER 1

USER 2

Please unplug the adaptor to depart from

the using utility power.

Note:

The adaptor interface is located on the right side of the monitor. Place NO obstacles

on the right side for easy pull-off adaptor.

Component list of

pressure measuring system

1 Cuff

2 Air pipe

3 PCBA

4 Pump

5 Valve

LCD DISPLAY

BATTERY COMPARTMENT

Installing and Replacing the Batteries

Open the battery door.

Insert the batteries according to the polarity

indications.

Close the battery door.

List

1.Blood Pressure Monitor

3. 4×AAA batteries

2.Cuff (Type BF applied part) (22cm-32cm)

(Please use iChoice authorized cuff.

The

size of the actual cuff please refer to

the

label on the attached cuff.)

4.User manual

CAUTION

In order to achieve the best performance and protect your monitor,

please use the authorized / specified battery and power adaptor.

Replace the batteries under following circumstances:

displays on the LCD.

The LCD display dims.

When powering on the monitor, the LCD doesn’t light up.

CAUTION

Remove batteries if the device is not likely to be used for some time.

Worn batteries are harmful to the environment. Do not dispose with daily garbage.

Remove the old batteries from the device following your local recycling guidelines.

Do not dispose of batteries in fire. Batteries may explode or leak.

AC adaptor

CUFF

AIR PIPE

AIR CONNECTOR PLUG

INTRODUCTION

BEFORE YOU START

Setting Date, Time and Measurement Unit

Please proceed to time setting before your initial use so as to ensure

each piece of record is labeled with a time stamp.

NOTE: The monitor will shut off in 60 seconds after last

operation when in Setting Interface.

When the monitor is OFF,

press and hold “User 1” button

to enter

Time Setting Mode.

As picture on the right, the

blinking numeral represents the

[HOUR].Press “Query” button to

change the numeral. Each press

Repeat steps 2 and 3 to confirm the [MINUTE]. Then the

monitor diverts to [MONTH] and [DAY] setting.

MONTH DAY

Repeat steps 2 and 3 to confirm [MONTH] and [DAY]. Then

the monitor diverts to [YEAR] setting.

YEAR

Repeat steps 2 and 3 to confirm [YEAR]. Then the monitor

diverts to [UNIT] setting.

will increase the numeral by one

in a cycling manner. HOUR

3.Press “User 1” button to confirm

the

[HOUR].

Then the monitor

diverts to [MINUTE] setting .

MINUTE

7.After confirming the measurement unit, the LCD will display “dOnE”

and the monitor will shut off .

BEFORE YOU START

Install App and Pair-Up

Before you start pairing, please download the app from APP Store or

Google Play in your mobile device which supports Bluetooth 4.0 technology first.

Turn on Bluetooth and the App. Make sure both are ON

when pair-up is proceeding.

2. When the monitor is off, press and hold “User 2” button to start

pair-up. Symbol and symbol will be shown on the

LCD alternatively, indicating Pair-up is proceeding.

If SUCCEED, symbol will be

shown on the LCD.

If FAIL, symbol will shown

on the LCD.

Apply the Cuff

Insert the plug of cuff’s air pipe into

the interface located on the right side

of the monitor.

As pictured on the right, wear

the cuff on your upper arm.

Tighten the cuff up. Make sure the

cuff is fixed 2 to 3 centimeters above

your elbow.

Appropriate to insert one finger

when the cuff is tightened around

your upper arm.

Correct Posture:

Bare your arm or wear tights only when

starting measurement.

Sit comfortably and relaxed on a

proper-size chair.

The center of the cuff should be at the

same level as your heart.

Legs relaxed with the feet falling outwards.

Palms up.

Bluetooth Module No.: AW8001

RF Frequency Range: 2402 MHz to 2480 MHz

Output Power Range: 0 dBm

Supply Voltage: 1.8-3.6 V

Transmitting Distance: 10 meters

BEFORE YOU START

START MEASUREMENT

Start the Measurement

After correctly positioning the cuff, when the monitor is off,

press “User 1” (or “User 2”) button to turn on the monitor,

and it will complete the measurement process.

Recall the Records

1.When the monitor is OFF, press “Query”

button to retrieve the memory. The monitor

will display the average value of latest three

measurements.

1.LCD display

3.Inflating and measuring.

2.Adjust to zero.

4.Display and save the results, and the

data will be transmitted.

Press “Query” button again to rotate

the records. Up to 60 records will be

stored under each user ID.

The order of the record, date and time

will be displayed alternatively.

Press another user button to

switch to display another user’s

measurement data.

When User 2 has no record, the

LCD will display just like the picture

on the right.

5. Press “User 1” (“User 2”) button to turn off the monitor. Otherwise, the monitor

will shut off within 1 minute after last operation.

Tips:

A.When finishing the whole measurement, press another user button, the blood

pressure monitor will begin measuring again.

B.Maximum 60 records are both for user 1 and user 2.

Press the corresponding User ID button to turn off the monitor. Otherwise,

the monitor will shut off within 1 minute after last operation.

CAUTION

The most recent record (1) is shown first. Each new measurement

is assigned to the first (1) record. All other records are pushed back

one digit (e.g., 2 becomes 3, and so on), and the last record (60) is

dropped from the list.

START MEASUREMENT

DATA MANAGEMENT

INFORMATION FOR USER

Delete the Records

When under data enquiry

mode, press and hold “Query” button for

3 seconds to

clear memory. The LCD

will display the blinking “dEL ALL”.

Press “Query” button to confirm

clearing memory. The LCD will display

“dEL dOnE” indicates that the deletion is

complete, and then turn off.

Tips for Measurement

Measurements may be inaccurate if taken in the following

circumstances.

If you wish to stop clearing the

memory, you may press the other button,

rather than “Query” button to turn off the

monitor, or wait until the monitor shuts off.

Data Transmission

With successfully pair-up with your mobile device with Bluetooth 4.0 technonlogy,

the measurement data will be automatically transmitted to your mobile device via

Bluetooth.

The symbol will disappear after successful data transmission, and you may

check your personal health data stored in your mobile device.

If the data transmission fails, the symbol will remain. The pending measurement

data will be transmitted to your mobile device when next measurement is complete.

Within 1 hour

after dinner or drinking

Within 20 minutes

after taking a bath

In a very cold environment

Immediate measurement

after tea, coffee,

smoking

When talking or moving your fingers

When you want to discharge urine

CAUTION

Interference may occur in the vicinity of equipment marked with the following

symbol

. And the monitor may interfere vicinity electrical equipment.

To enable the data transmission function, this product should be paired to a

Bluetooth end at 2.4 GHz.

How to mitigate possible interference?

The range between the monitor and the Bluetooth end should be reasonably close,

from 1 meter to 10 meters. Please ensure no obstacles between the monitor and the

Bluetooth end so as to obtain quality connection.

To avoid interference, other electronic devices (particularly those with Bluetooth

transmission / Transmitter) should be kept at least 1 meter away from the monitor.

DATA MANAGEMENT

INFORMATION FOR USER

ABOUT BLOOD PRESSURE

CAUTION

The appearance of the IHB icon indicates that a pulse irregularity consistent with

an irregular heartbeat was detected during measurement. Usually this is NOT a

cause for concern. However, if the symbol appears often, we recommend you

seek medical advice. Please note that the device does not replace a cardiac

examination, but serves to detect pulse irregularities at an early stage.

Maintenance

What are systolic pressure and diastolic pressure?

To obtain the best performance, please follow instructions below.

When ventricles contract and pump blood out

of the heart, the blood pressure reaches its

maximum value in the cycle, which is called

systolic pressure. When the ventricles relax,

the blood pressure reaches its minimum

value in the cycle, which is called diastolic

pressure.

What is the standard blood pressure classification?

The chart on the right

illustrates the blood

pressure classification

mode by American Heart

Association (AHA).

The AHA recommends

the following guidelines

for upper limit of normal

blood pressure readings

at home.

AHA Home Guideline for Upper Limit of Normal

Systolic Blood Pressure

135 mm Hg

Diastolic Blood Pressure

85 mm Hg

Irregular Heartbeat Detector

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is

measuring the systolic and diastolic blood pressure. During each measurement,

this equipment records the heartbeat intervals and works out the standard deviation.

If the calculated value is larger than or equal to 15,the irregular heartbeat symbol

appears on the symbol when the measurement results are displayed.

Systolic

blood discharging

artery

press

Diastolic

blood entering

vein

relax

This chart reflects blood pressure categories defined by American Heart Association.

Put in a dry place and

avoid the sunshine

Avoid immersing it in the water.

Clean it with a dry cloth in case.

Avoid shaking and collisions

Avoid dusty environment and

unstable temperature surrounding.

Use the slightly damp cloth

to remove the dirt.

Avoid washing the cuff.

Blood Pressure Category

Systolic

mmHg (upper#)

Diastolic

mmHg (lower#)

Normal

less than 120

and

less than 80

Prehypertension

120-139

80-89

High Blood Pressure

(Hypertension) Stage 1

140-159

90-99

High Blood Pressure

(Hypertension) Stage 2

160 or higher

100 or higher

Hypertensive Crisis

(Emergency care needed)

Higher than 180

Higher than 110

ABOUT BLOOD PRESSURE

TROUBLESHOOTING

Why does my blood

pressure fluctuate

throughout the day?

Individual blood pressure varies

multiple times everyday. It is also affected

by the way you tie your cuff and your

measurement position, so please take the

measurement under the same conditions.

If the person takes medicine, the

pressure will vary more.

Wait at least 3 minutes for another

measurement.

Why do I get a different

What you need to pay

This section includes a list of error messages and frequently asked

questions for problems you may encounter with your blood pressure

monitor. If the products not operating as you think it should, check here

before arranging for servicing.

blood pressure at home attention to when you measure

compared to the hospital? your blood pressure at home:

The blood pressure is different even

throughout the day due to weather,

emotion, exercise etc, Also, there is the

“white coat” effect, which means blood

pressure usually increases in clinical

settings.

Is the result the same if

measuring on the right

arm?

If the cuff is tied properly.

If the cuff is too tight or too loose.

If the cuff is tied on the upper arm.

If you feel anxious.

Taking 2-3 deep breaths before

beginning will be better for measuring.

Advice: Relax yourself for 4-5

minutes until you calm down.

It is ok for both arms, but there

will be some different results for

different people. We suggest you

measure the same arm every time.

Error

message

PROBLEM

SYMPTOM

CHECK THIS

REMEDY

No power

Display

will not light up.

Batteries are exhausted.

Replace with new batteries

Batteries are inserted

incorrectly.

Insert the batteries

correctly

AC adaptor is inserted

incorrectly.

Insert the AC adaptor

tightly

Low

batteries

Display is dim or

shows

Batteries are low.

Replace with new batteries

E 1 shows

Communication error

Check if the APP is on,

operate and send the data

again.

E 3 shows

The cuff is not secure.

Readjust the cuff and

relax for a moment

and then measure again.

E10 or E11

shows

The monitor detected

motion while measuring.

Movement can affect the

measurement. Relax for

amoment and then

measure again.

E20 shows

The measurement

process does not detect

the pulse signal.

Loosen the clothing on the

arm and then measure

again

E21 shows

The treatment of the

measurement failed.

Relax for a moment and

then measure again.

EExx, shows

on the display.

A calibration error

occurred.

Retake the measurement.

If the problem persists,

contact the retailer or our

customer service

department for further

assistance. Refer to the

warranty for contact

information and return

instructions.

SPECIFICATIONS

AUTHORIZED COMPONENT

Adaptor

Type: UE08WCP-060100SPA

Input: 100-240V 50-60Hz,400mA

Output: 6V 1A

(Conforms to UL Certification)

Power supply

Battery Powered Mode:

6V (4 x AAA-size batteries)

AC Adaptor Powered Mode:

6V 1A

(Can be supplied by AC adaptor model

UE08WCP-060100SPA!)(Not Included)

Authorized Component

Please use the iChoice

authorized adaptor. (Not Included)

Display mode Blue LCD with White Backlight

V.A. = 125mm(L) x 47mm(W)

Measurement mode Oscillographic testing mode

Pressure: 0mmHg~300mmHg(0kPa-40kPa)

Measurement range Pulse value:(40-199)times/minute

Accuracy

Contact Information

Working condition For more information about our products, please visit &www.ichoicelife.com.you can get

customer service, usual problems and customer download, iChoice will serve you

anytime.

Distributed by:

Beijing Choice Electronic Technology Co.,Ltd.

Address: Room 4104, No.A12 Yuquan Road Haidian District

100143 Beijing P.R.China

Complied Standards List

Risk Management

ISO 14971:2007

Labeling

EN 980:2008

User Manual

EN 1041:2008

Generl Requirements

for Safety

IEC 60601-1:2005/A1:2012

Performance and

Clinical

Requirements

ANSI/AAMI/IEC 80601-2-30:2009

ANSI/AAMI/ISO 81060-2:2009

Electromagntic

Compatibility

IEC 60601-1-2:2007

Pressure:

5oC-40oC within ±3 mmHg (0.4 kPa)

Pulse Value: ±5%

Temperature:5oC-40oC

Relative Humidity: ≤85%RH

Atmospheric Pressure: 86kPa-106 kPa

Type BF applied part&

Battery Powered Mode: Internally Powered ME

Equipment

V01&

WARNING: No modification of this equipment is allowed.

20&

About 22cm-32cm&

Weight&

Approx.388g(Excluding the dry cells)

External dimensions

Attachment

Temperature:-20 oC -60 oC

Relative Humidity: 10%RH-93%RH

Atmospheric Pressure: 50kPa-106 kPa

Storage & transportation

condition

Measurement perimeter

of the upper arm

Approx.182.5mm×100mm×39mm

4×AAA batteries, user manual&

Mode of operation&

Continuous operation&

Degree of protection&

Device Classification&

IP Classification

IP22

Software Version&

EMC GUIDANCE

FCC Statement

Note:

POTENTIAL FOR RADIO/TELEVISION INTERFERENCE (for U.S.A. only)

This product has been tested and found to comply with the limits for a Class B digital

device, pursuant to Part 15 of FCC Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation.

The 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 the product does cause harmful interference to radio or television

reception, which can be determined by turning the product on / off, 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 product and the receiver.

- Connect the product into an outlet on a circuit which is different from what the receiver is

connected to.

- Consult the dealer or an experienced radio / TV technician for help.

Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic

IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS

EMC guidance

Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS –

for all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below.

The customer or the user of the device should assure that it is used in such an

environment.

Emissions test

Compliance

Electromagnetic environment – guidance

RF em issions

CISPR 11

Group 2

The device must emit electromagnetic

energy in order to perform its intended

function. Nearby electronic equipment may be affected.

RF em issions

CISPR 11

Class B

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Not applicable

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified

below.

The customer or the user of the device should assure that it is used in

such an

environment

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic

environment -

guidance

Electrostati

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

floors

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

±1 kV for

input/output

lines

±2 kV for

power

supply

lines

Mains power quality

should

be that of a

typical

commercial or

hospital

environment.

Surg

e IEC

6100

0-4-5

±1 kV line(s)

to line(s)

±2 kV line(s)

to earth

±1 kV

line(s) to

line(s)

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 s

<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 s

Mains power quality

should

be that of a

typical

commercial or

hospital

environment.

If the user of

the

device requires

continued operation

during

power mains

interruptions,

it is

recommended that the

device be powered

from an

uninterruptible power

supply

or a battery.

Power

frequency

(50/60Hz)

magnetic

field

IEC

61000-4-8

3A/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.

Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –

for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Table 6 Recommended separation distances between portable and mobile

RF communications equipment and the ME EQUIPMENT or ME SYSTEM –

for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances

between portable and mobile RF communications equipment and the device.

The device is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the device

can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF communications equipment (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

d = 1.167 P

80 MHz to 800 MHz

d = 1.167 P

800 MHz to 2.5 GHz

d = 2.333 P

0.01

0.117

0.233

0.1

0.369

0.738

1.167

2.333

3.690

7.378

100

11.67

23.33

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (m) can be estimated using the equation applicable to

the frequency of the transmitter, where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency

range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects and people.

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below.

The customer or the user of the device should assure that it is used in such an environment.

IMMUNITY test

IEC 60601

TEST

LEVEL

Complia

nce

level

Electromagnetic

environment -

guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to

80 MHz

3 V/m

80 MHz to

2.5 GHz

3 Vrms

3 V/m

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

d = 1.167 P

d = 1.167 P 80 MHz to 800 MHz

d = 2.333 P 800 MHz to 2,5 GHz

where P is the maximum output

power

rating of the transmitter in

watts (W)

according to the

transmitter manufacturer

and d is the

recommended separation

distance in

metres (m).

Field strengths from fixed RF

transmitters, as determined by an

electromagnetic site survey, a

should be

less than the compliance

level in each

frequency range.b

Interference may occur in the

vicinity of

equipment marked with

the following

symbol:

NOTE 1 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.

Field strengths from fixed transmitters, such as base stations for radio (cellular /

cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-

cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the

electromagnetic environment due to fixed RF transmitters, an electromagnetic site

survey should be considered. If the measured field strength in the location in which the

device is used exceeds the applicable RF compliance level above, the device should be

observed to verify normal operation. If abnormal performance is observed,

additional

measures may be necessary, such as re-orienting or relocating the device.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

EMC GUIDANCE

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