HoMedics BPA-945 User manual

AUTOMATIC ARM
BLOOD PRESSURE MONITOR
M
START
STOP
Pul
BPA-945, BPA-945-WT
Doc: L-01511, Rev. 2

IMPORTANT PRODUCT NOTICES
AND SAFETY INSTRUCTIONS
When using your blood pressure monitor, basic precautions
should always be followed. Please read and follow all instructions
and warnings before using this product. Save these instructions
for future reference.
The device can accurately measure blood pressure in pregnant
patients including those with known or suspected preeclampsia
conditions.
Measurement position is at the human being's upper arm. This
device is intended for over-the-counter home use in adults 18
years and older with an arm circumference ranging from 9 inches
to 17 inches (approx. 23cm to 43cm).
• Please note that this is a home healthcare product only
and this manual and device are not intended to serve
as a substitute for the advice of a physician or medical
professional. ·
• This device uses the oscillometric method to measure systolic
and diastolic blood pressure, as well as heart rate.
• DO NOT use this device for diagnosis or treatment of
any health problem or disease. Measurement results are
for reference only. Consult a healthcare professional for
interpretation of pressure measurements. Contact your
physician if you have or suspect any medical problem. Do not
change your medications without the advice of your physician
or healthcare professional.
• Proper cuff size is critical for accurate measurements. Follow
the instructions in this manual and printed on the arm cuff to
ensure the arm cuff is used properly.
• If you are pregnant, you should pay more attention to your
blood pressure changes because during this time, it may
change drastically.
• This monitor is clinically validated for use in pregnancy
and pre-eclampsia. When you detect unusual readings in
pregnancy, you should measure again after taking some
rest. If the reading is still abnormal, consult your doctor or
gynecologist.
• This product is not suitable for:
0 People with arrhythmias
0 People undergoing intravenous injection on any limb
0 People currently
in a dialysis treatment
• For those who have had a mastectomy or lymph node
clearance, it is recommended to take a measurement on the
unaffected side.
• This device may have difficulty determining proper blood
pressure for users with irregufar heartbeat, diabetes, liver
disease, kidney disease, poor circulation of the blood or
for users who have suffered a stroke. Please consult your
healthcare professional before using this device.
• Excessive use may result in blood flow interference, which
is likely to cause uncomfortable sensations, such as partial
subcutaneous hemorrhage, or temporary numbness to
your arm. In general, these symptoms should not last long.
However, if you continue to experience these sensations,
please seek advice from a medical professional.
• When used along with other medical electronic equipment on
the same arm, pressurization ofthe cuff may cause the other
devices to temporarily malfunction.
• The pulse display is not suitable for checking the frequency of
heart pacemakers.
• Electromagnetic interference: The device contains
sensitive electronic components. Avoid strong electrical or
electromagnetic fields in the direct vicinity of the device (e.g
mobile telephones, microwave ovens). These may lead to
temporary impairment of measurement accuracy.
• Consider the electromagnetic compatibility of the device
(ex. power disturbance, radio frequency interference etc.)
Please use this device indoors only.
• Use blood pressure monitor only for its intended use.
• DO NOT wrap the cuff around body parts other than
your arm.
• DO NOT use this device on infants, children, or those who
cannot express their own intention.
• DO NOT plug or unplug the adapter power cord with
wet hands.
• Please use 1.5V "AA" alkaline batteries for power supply.
• Please rest for at least 5-1 Ominutes before taking a
measurement.
• To allow your blood vessels to return to the condition prior
to taking the measurement, please wait at least 3-5 minutes
between measurements. You may need to adjust the wait
time according to your personal physiological situation.
• Wait 30-45 minutes before measurement if you've just
consumed caffeinated beverages or smoked cigarettes.
• The applied part is the cuff.
• The patient is the intended operator.
Blood pressure measurements determined with this device
are equivalent to those obtained by a trained observer using
the cuff/stethoscope auscultatory method, within the accuracy
limits prescribed by the American National Standard, Manual,
electronic, or automated sphygmomanometers.
In the event that the device needs to be checked for calibration,
contact the distributor.

ABOUT BLOOD PRESSURE
What is Blood Pressure?
Blood pressure is the measurement of the force exerted on the
artery walls while blood flows through the arteries. The pressure
measured when the heart contracts and sends blood out of the
heart is systolic (highest) blood pressure. The pressure measured
when the heart dilates with blood flowing back into the heart is
called diastolic (lowest) blood pressure.
Why Measure Your Blood Pressure?
Among today's various health problems, those associated with
high blood pressure are very common. High blood pressure
dangerously correlates with cardiovascular diseases. Therefore,
blood pressure monitoring is important for identifying those at
risk.
Why Do My Readings Vary?
Blood pressure is a body parameter that is subject to normal
variations throughout the day. A single reading that is different
from yours or your doctor's readings are not necessarily
inaccurate. The average of several readings, taken under similar
conditions, using the same arm is preferred for accurate blood
pressure readings.
Why Are My Readings Different Than Those Taken at My
Doctor's Office?
Many experience a phenomenon called "White Coat
Hypertension" when measured by a doctor. White Coat
Hypertension refers to blood pressure that rises above its usual
level when measured in a clinical setting, such as a doctor's
office.

BLOOD PRESSURE STANDARD
The table below contains defined levels for hypertension that are
publicly available from the American Heart Association® (AHA
2017). Users can compare their own blood pressure readings
against these defined levels to determine if they may be potentially
at increased risk. This table is applicable to most adults aged 18
and older.
Blood Pressure
Systolic mmHn
Diastolic mmHY
Indicator
· Category (upper numbe (lower number Symbol
Normal <120 and <80
Elevated
120 - 129 and <80 ©
High Blood Pressure 130-139
or
80-89
Q)
(hypertension) Stage 1
High Blood Pressure 140-180
or 90-120 @
(hypertension) Stage 2
Hypertensive Crisis
co
(consultyour doctor
>180 and/or >120
immediately)
*Source: American HeartAssociation (AHA) 2017
Blood pressure tends to go up and down, even in people who normally
don't have high readings. If your numbers stay above the "normal" range
most of the time, you may be at increased risk and should consult your
physician.
Although one can easily find where their own blood pressure readings fall
on this table, this monitor comes equipped with a Risk Category Index that
automatically compares each reading to the defined levels and provides a
helpful cue if your reading falls into one of the stages that could potentially
indicate increased risk. See Risk Category Index section for more
information on this feature.
Please note that cues provided by this monitor are only intended to
assist you in using this table. The table and cues are only provided for
convenience to help you understand your non-invasive blood pressure
reading as it relates to the American Heart Association® (AHA 2017).
They are not a substitute for a medical examination or diagnosis by your
physician. It is important for you to consult with your physician regularly.
Your physician will tell you your normal blood pressure range as well as
the point at which you may actually be considered to be at risk.

HOW THIS BLOOD PRESSURE MONITOR WORKS
This monitor uses SmartMeasure® technology to detect your
blood pressure. With one touch of the start/stop button, the monitor
will turn on and the inflation will automatically start, creating
pressure around the arteries inside the wrist.
Within the cuff is a gauge which senses the fluctuations
(oscillations) in pressure. The fluctuation measured represents
the degree of intensity that your arteries are contracting with each
heartbeat, which is also a result of the pressure that the cuff has
placed on the wrist. The monitor measures these contractions and
converts the information to a digital value. Once the measurement
is complete, the cuffwill automatically deflate, and the result is
displayed on the screen. Please note that any muscle movement
during inflation will cause measurement error. When measurement
is complete, the monitor will display your systolic pressure,
diastolic pressure, and pulse readings.
The monitor automatically finds where your measurement results fall
on the American HeartAssociation (AHA 2017) table and provides a
cue if your reading falls into one of the stages that could potentially
indicate increased risk. Please refer to Risk Category Index section
for more information on thisfeature.
The appearance of the 11: 1 :J icon indicates that a pulse irregularity
consistent with an irregular heartbeat was detected during
measurement. Refer to Irregular Heartbeat Detectorsection.

NAME/FUNCTION OF EACH PART
Arm Cuff
Air Tube
and Connector
M ,llARJ.
I STOP
MEMORYRECALL/ --...L-----1----
Button
Note:
START/STOP
Button
LCD Display
Battery Cover
(Located on
bottom of unit)
The START/STOP and M buttons are also used to set the date and time.
Other Accessories:
4 "AAA" size, 1.5Valkaline batteries (included)

DISPlAY SYMBOL EXPlANATIONS
©
,~1r1
-
11:1:1
1r1 •· Systolic
Pressure
p
~~~
!ERRORI
r1r1
171 • Diastolic
Pressure
Date/Tim~
~-
Indicator I :J / -=a □ / -=a I •
ri:i ,
IC: CO C I
,=,-=,c
Pulse
IL · -1 -1 PM
IL Symbol
Display Symbol Explanations:
Ci
Low Battery Symbol: Appears when batteries should be
replaced.
• Pulse Symbol: Shows the heart rate per minute.
mm
Irregular Heartbeat Detector: See Irregular Heartbeat
Detector section for more information.
© Risk Category Index: See the
Risk Category Index section
for more information.
If!ERROR! and any of the following letters and numbers appear in the
area that systolic pressure should be displayed, an error has occurred
with your reading. See Troubleshooting section of this manual for
more information.
EE
Measurement Error: Wrap the cuff correctly and keep arm
steady during measurement. Measure again.
E: Air Circuit Abnormality: Check cuff connection. Measure again.
E2
Pressure Exceeding 300 mmHg: Turn the unit off to clear,
then measure again.
E3
Error Determining Measurement Data: Measure again.
CC•
System Error: Turn off monitor and measure again. If ' EP '
L.J
error still appears on the display, please call a Consumer
Relations representative.

INSTALLING BA TT.ERIES
1. Press down on latch and lift the battery cover to open the
battery compartment.
2. Install or replace 4 "AAA" sized batteries in the battery
compartment according to the indications inside the
compartment.
3. Close the battery cover by pushing in the top end of the
battery door.
____ Battery
Cover
1-e® A
Replace the batteries if: ~
• The low battery symbol appears on the display.
• Nothing appears on the display when the power is switched on.
Note:
• Date and time will need to be reset if batteries are removed or
replaced.
• Replace all batteries at one time (as simultaneous set). Use
only 1.5V "AAA" alkaline batteries. Do not mix alkaline, standard
(carbon-zinc) or rechargeable (cadmium) batteries.
• Remove batteries when unit is not in use for extended periods of
time.
• When the batteries are removed, the measurement values stored
in memory are retained. However, the date and time must be
re-set.
• Clean contacts on battery and in battery compartment with a soft
dry cloth each time you install batteries.
• Batteries are hazardous waste. Do not dispose of them
together with the household garbage.
• DO NOT dispose of batteries in fire. Batteries may explode or
leak.
• Recycle or dispose of properly in accordance with local, state,
province, and country regulations.

DATE & TIME SET ' PROCEDURE
1. To adjust the date and time, press and hold the START/
STOP button for 3 seconds.
2. The display will show a blinking number showing the
MONTH. Change the MONTH by pressing the M button.
Each press will increase the number by one in a cycling
manner. Press the START/STOP button again to confirm
the entry, and the screen will show a blinking number
representing the DAY.
3. Change the DAY, YEAR, HOUR, & MINUTE as described in
Step 2. above, using the M button to change the numbers
and the START/STOP button to confirm the entries.
Press & hold the
START/STOP button
'
blinking MONTH
'
increasing MONTH
'
I
· START J confirm the entry
_ STOP ~ f
repeat process to set DAY, YEAR, HOUR
and MINUTE

USING THE ARM CUFF
Very Important: Proper cuff size is critical to accurate
measurement.
This monitor comes with a universal size arm cuff
that fits arms 9"-17" (23cm-43cm).
This cuff is suitable for your use if the colored arrow
falls within the solid color line as shown below. If
the arrow falls outside of the solid color line, you
will need to contact HoMedics Consumer Relations
to purchase an XL arm cuff (17"-22", 43cm-56cm) at
1-800-466-3342.
Colored Arrow
I
Solid Colored Line
1. If the cuff is not assembled, pass the end of the
cuff furthest away from the tubing through the metal
D-ring in order to form a loop. The smooth side without
5. Position cuff edge 0.8-1.2
inches (2-3 cm) above elbow.
6. Center tube over middle of arm.
7. Pull the end of the cuff so that it tightens ~
evenly around your arm. Press the hook .
and loop material together to secure.
Allow room for 2 fingers to fit between the
cuff and your arm. Please make sure the cuff does not slip
during measurement, and the arrow falls within the proper
fit range.
8. Lay your arm on a table (palm upward) so the
cuff is at the same height as your heart. Make
sure the tube is not kinked.
the felt material should be on the inside of the cuff loop. Note:
End of cuff
D-ring
2. Plug the cuff tube into the left side of the unit.
Insert plug her_: __ ..._ \:< -
. .--;_:;.-
3. Open the arm cuff so that your arm may be placed
through it.
4. Wrap the cuff on a bare arm or over thin clothing. Thick
clothing or a rolled-up sleeve will cause inaccurate blood
· pressure measurements.
• This device should not be used when your arm is
wounded or injured.
• If it is not possible to fit the cuff on your left arm, it can also
be placed on your right arm. However, all measurements
should be made using the same arm.
• To use on the right arm, you must position the artery
symbol "<I> "over the main artery. Locate the main artery
by pressing with two fingers approximately 1" (2 cm)
above the bend of your elbow on the inside of your right
arm. Identify where the pulse can be felt the strongest.
This is your main artery.

RECALLING VALUES FROM MEMORY
1. Press the M button to access the memory.
)1J r ~~~u
2. Every new press of the M button will recall a previous
reading. The latest reading will be recalled first.
~-=-=---
© 1--1r1
© I. 11-1 I
1
6 iiii
□ LI ;
12/28/21 .,J 1,
12/28/21 12:YSPM I[ I
12 : 35 ;:
CLEARING VALUES FROM MEMORY
Press and hold the START/STOP + M buttons at the same
time while in memory recall mode, and the data will be
erased automatically. .. r1n
-
LLt I
Note:
Once deleted, your readings can not be restored.

IMPORTANT NOTES REGARDING YOUR BLOOD
PRESSURE MEASUREMENT
• Take your reading in a comfortable environment as
measurements can be affected by hot or cold temperatures.
• Take your blood pressure at normal body temperature.
• DO NOT move or talk during measurement as this can
elevate readings.
• DO NOT move or cross legs during measurement. Keep
feet flat on floor.
• DO NOT touch cuff or monitor during measurement
procedure.
• It is suggested that you take your measurements at the
same time each day and use the same arm for consistency.
• Users should wait a minimum of 5 minutes before taking
additional measurements. More time may be necessary
depending upon your physiology.
• The measurement results that users receive are for
reference only. If users have any blood pressure concerns,
please consult a physician.
• Once inflation reaches 300 mmHg, the unit will deflate
automatically for safety reasons.
• This device may have difficulty determining the proper
blood pressure for users with irregular heartbeat, diabetes,
poor circulation of blood, kidney problems, or for users who
have suffered a stroke.

CARE, MAINTENANCE & CLEANING
• Clean the blood pressure monitor body and cuff carefully
with a slightly damp, soft cloth. Do not press. Do not wash
cuff or use chemical cleaner on it. Never use thinner,
alcohol or petrol (gasoline) as cleaner.
• Make sure the cuff is completely dry before using.
• Leaky batteries can damage the unit. Remove the batteries
when the unit will not be used for a long time.
• Follow local ordinances and recycling instructions
regarding disposal or recycling ofthe device and device
components, including batteries.
• If the unit is stored near freezing, allow it to acclimate to
room temperature before use.
• This blood pressure monitor is not field serviceable. You
should not use any tool to open the device nor should you
attempt to adjust anything inside the device. If you have
any problems with this device, please contact HoMedics
Consumer Relations (contact information can be found in
the Warranty section).
• DO NOT immerse the unit in water as this will result in
damage to the unit.
• DO NOT subject the monitor or cuff to extreme
temperatures, humidity, moisture, or direct sunlight. Protect
from dust.
• DO NOT fold the cuff and tubing tightly.
• DO NOT disassemble the monitor or cuff. If in need of
repair, refer to the Warranty section of this manual.
• DO NOT subject the monitorto extreme shocks (do not
drop on floor).
• DO NOT inflate the cuff unless wrapped around arm.
• DO NOT wrap the cuff around body parts other than your
arm.
• DO NOT drop or insert any object into any opening or
hose.
• To avoid accidental strangulation keep this product away
from children. Do not drape tube around neck.
• This monitor may not meet its performance specifications if
stored or used outside of these temperature and humidity
ranges:
Storage/Transportation
Environment
Temperature: -13°F~ 158°F
{-25° C~ 70° C)
Humidity: less than 93% RH
Operating
Environment
Temperature: 41 ° F~104 °F {5 °C ~40°C)
Humidity: 15% ~ 93% RH
Atmospheric Pressure: 700hPa-1060hPa

MEASUREMENT PROCEDURE
Notes:
• Blood pressure changes with every heartbeat and is in constant
fluctuation throughout the day.
• Blood pressure measurement can be affected by the position of
the user, his or her physiologic condition and other factors.
Before Measurement:
To help ensure an accurate reading, follow these instructions before
taking a measurement:
• Wait 1 hour after exercising, bathing, eating, drinking beverages
with alcohol or caffeine, or smoking to measure blood pressure.
• Sit quietly and rest for 15 minutes.
• Stress raises blood pressure. Avoid taking measurements during
stressful times.
• Take your reading in a comfortable environment as
measurements can be affected by hot or cold temperatures.
Take your blood pressure at normal body temperature.
During Measurement:
• DO NOT talk or move your arm or hand muscles.
• DO NOT cross your legs. Sit with feet flat on the floor.
• DO NOT touch cuff or monitor during measurement.
1. With the cuff wrapped around your arm, press the START/STOP
button. Do not inflate the cuff unless it is wrapped around your
arm. All digits will light up to check the display functions. The
checking procedure will be completed after about 3 seconds.
~
p □□ r nr1 ·
' ~ nTART J -11-,1-, 1 11 ,
' ~
1
~ - ... -,F1 □ ... --
~"' ICICI
IB/aB/BB 199! 1 [«(i'BJ?I
18 BB N •1 ~ 12 35 ~
2. After all symbols disappear, the display will show "00". The
monitor is "Ready to Measure" and will automatically inflate
the cuff to start measurement.
3. When the measurement is completed, the
cuff will deflate entirely. Systolic pressure,
diastolic pressure and pulse will be shown
simultaneously on the LCD screen. The
measurement is then automatically stored
into memory.
Note:
® 1-1r1
ICLI
r1r1
CILI
12_RB/ll • nJ
12 :35 ,.. IC: .
• This monitor automatically turns off approximately 1 minute after
last operation. You may also press the START/STOP button to
turn the unit off.
• To interrupt the measurement, you may press the START/
STOP (recommended) or M buttons.
The cuff will deflate immediately after a button is pressed.
• If the cuff does not stop inflating, remove the cuff at once.

RISK CATEGORY INDEX
This monitor comes equipped with a Risk Category Index that
automatically compares each reading to defined levels established
by the American Heart Association® (AHA 2017) as described
earlier in this manual, and provides a helpful cue if your reading
falls into one of the stages that could potentially indicate increased
risk. No cue is given if the reading falls in the normal range as
defined by American Heart Association®. Please note that cues
provided by this monitor are only intended to assist you in using
this table. The table and cues are only provided for convenience
to help you understand your non-invasive blood pressure reading
as it relates to the American Heart Association® information.
They are not a substitute for a medical examination or diagnosis
by your physician. It is important for you to consult with your
physician regularly. Your physician will tell you your normal blood
pressure range as well as the point at which you may actually be
considered to be at risk.
Blood Pressure
Systolic mmH~ Diastolic mmHJ
Indicator
Category
(upper numbe (lower number Symbol
Normal <120 and <80
Elevated 120-129 and <80 ©
High Blood Pressure
130-139 or 80-89
CD
(hypertension) Stage 1
High Blood Pressure
140-180 or
90-120 ©
(hypertension) Stage 2
Hypertensive Crisis
©
(consult your doctor
>180
and/or
>120
immediately)
*Source: American HeartAssociation (AHA) 2017

IRREGULAR HEARTBEAT DETECTOR (IHB)
The appearance of the o:mJ
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.
© 1
~1,~,
Irregular
Heartbeat -l~~ 11--1 I
Detector
----
r1r1
□ LI
:2/28/21 • ,J
12:3S PM ILJ
Movement, shaking or talking during the measurement can result
in pulse irregularities that may cause the appearance of this icon.
Therefore, it is of great importance to not move or talk during
measurement.
To determine the presence of an irregular heartbeat, the average
of the heartbeat intervals is calculated with the first 3 normal
effective heartbeat values. It is important to note that the average
is not a strict mathematical averaging of all recorded intervals.
At least 3 beats with 25% or greater difference from the average
heartbeat interval will generate the mm icon on the screen.
Important Information:
This blood pressure monitor is not designed for use by people
with arrhythmias nor for diagnosing or treating an arrhythmia
problem. As a safeguard, we recommend that if you have
arrhythmias such as atrial or ventricular premature beats and
atrial fibrillation or any other special conditions you should check
with your physician before using your blood pressure monitor.

MEASUREMENT PROCEDURE
Notes:
• Blood pressure changes with every heartbeat and is in constant
fluctuation throughout the day.
• Blood pressure measurement can be affected by the position of
the user, his or her physiologic condition and other factors.
Before Measurement:
To help ensure an accurate reading, follow these instructions before
taking a measurement:
• Wait 1 hour after exercising, bathing, eating, drinking beverages
with alcohol or caffeine, or smoking to measure blood pressure.
• Sit quietly and rest for 15 minutes.
• Stress raises blood pressure. Avoid taking measurements during
stressful times.

POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE
To avoid inaccurate results caused by electromagnetic interference between
electrical and electronic equipment, do not use the device near a cell
phone or microwave oven. For most wireless communication devices, it is
recommended to maintain a distance of 10.8
feet (3.3m) in order to avoid electromagnetic
interference.
This device complies with Part 15 ofthe 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.
FEDERAL COMMUNICATIONS COMMISSION COMPLIANCE STATEMENT
Changes or modifications to this equipment not expressly approved by the
manufacturer 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 ofthe 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.

ELECTROMAGNETIC COMPATIBILITY (EMC)
• Guidance and manufacturer's declaration -electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be used in such
environments:
Emissions test Compliance Electromagnetic
environment- guidance
RF emissions CISPR 11 Group 1 RF energy is used only to maintain device's operation.
RF emissions CISPR 11 Class B Therefore, its RF emissions are
so lowthat it's not likely to
cause any interference in nearby electronic equipment.
Harmonicemissions IEC Not
The device is suitable for use in all establishments, including
61000-3-2 Applicable domestic establishments,and those directlyconnected to
Voltage fluctuations/ flicker
the public low-voltage power supply networkthat supplies
Not buildings used fordomestic purposes.
emissions IEC 61000-3-3 Applicable
• Guidance and manufacturer's declaration -electromagnetic Immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such
environments:
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-
guidance
Electrostatic ± 8 kV
contact discharge ± 8 kV contact
In the case of air discharge
discharge (ESD) ±
15 kV air discharge discharge
testing, the climatic conditions
IEC 61000-4-2 ± 15 kV air discharge
shall be within the following
ranges:
Ambient Temperature:
15 C0 ~35C
0
Relative Humidity: 30%-60%.
Powerfrequency
30Nm 30Nm
Power frequency magnetic fields
magneticfield
50 or 60 Hz 50 or 60 Hz
should be at levels characteristic of
IEC 61000-4-8 a typical location
in atypical com-
mercial or hospital environment.
• Guidance and manufacturer's declaration -electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such
environments:

Immunity
IEC 60601 test level Compliance Electromagnetic environment-
test
level
guidance
Conducted 3Vrms Not Portable and mobile RF communica-
RF At0.15- 80 MHz Applicable tions equipment should
be used
IEC 61000-
no closer to any part of the device,
4-6 6Vrms
including cables, than the recom-
At ISM & Radio Arna-
mended separation distance calcu-
teur Freq lated from the equation applicable
to
thefrequency of thetransmitter.
Radiated 10V/m at 80-2700 MHz 1OV/m
at 80-2700 MHz Recommended separation distance
RF AM Modulation AM Modulation Considering
to reduce the minimum
IEC 61000- And 9-28V/m at And 9-28V/m at separation distance, based
on
4-3 385-6000MHz,Pulse 385-6000MHz,Pulse RISK MANAGEMENT,
and using
Proximi ty Mode and other Modu- Modeand other Modula- higher IMMUNITY TEST LEVELS
fields from lation. The system shall tion. The system shall
that are appropriate for the reduced
RF wireless be tested as specified
be tested as specified minimum separation distance.
commu- in IEC60601-1-2 Table in IEC60601-1-2 Table 9 Minimum separation distances for
nications 9 for proximityfields for proximityfields from higher IMMUNITY TEST LEVELS
equipment from RF wireless com - RF wireless communica- shall be calculated using thefollow-
IEC 61000- munications equipment tions equipment using ing equation:
4-3 using the test methods the test methods speci-
specified in IEC tied in IEC 61000-4-
E=6'd , /p
61000-4-3 385-6000MHz,Pulse
Modeand other Modula- where P
is the maximum powerin
tion. The system shall W,
dis the minimum separation dis -
be tested as specified tance in m, and E
is the IMMUNITY
in IEC60601-1-2Table 9 TEST LEVELS in V/m.
for proximityfields from
RF wireless communica- Field strengthsfrom fixed
RF
tions equipment using transmitters, as determined
by an
thetest methods speci- electromagnetic site survey,a should
tied in IEC 61000-4-3 be less than the compliance level in
eachfrequency range.b
Interference may occur in the vicinity
of equipment marked with thefol-
lowing symbol:
(('il)
NOTE 1 At 80 MHz and 800 MHz, the higherfrequency range applies.
NOTE 2 These guidelines may notapply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengthsfrom 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 surveyshould be considered. If the measured field strength in the location in which
the device is used exceedsthe applicable RF compliance level above, the device should be observed to
verify normal operation. Ifabnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be lessthan 3 V/m