iHealth Labs BPM1 Blood Pressure Monitor User Manual BPM1AE REV
iHealth Labs Inc. Blood Pressure Monitor BPM1AE REV
Users Manual
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iHealth®
Blood Pressure Monitor (BPM1AE)
OWNER’S MANUAL
Table of Contents
INTRODUCTION ................................................................................................................... 2
PACKAGE CONTENTS .......................................................................................................... 2
INTENDED USE ................................................................................................................... 2
BLOOD PRESSURE CLASSIFICATION FOR ADULTS ....................................................... 2
CONTRAINDICATION .......................................................................................................... 3
PARTS AND DISPLAY INDICATORS ................................................................................. 3
SETUP AND OPERATING PROCEDURES ............................................................................ 3
Download The Free iHealth App ....................................................................................... 3
Set Wi-Fi ............................................................................................................................. 3
OPERATING PROCEDURES .................................................................................................. 4
Connecting The Cuff To The Monitor .................................................................... 4
Apply The Cuff ............................................................................................................... 4
Body Posture ................................................................................................................... 5
OPERATION INSTRUCTIONS ............................................................................................. 5
SPECIFICATIONS ............................................................................................................... 6
GENERAL SAFETY AND PRECAUTIONS ............................................................................ 7
BATTERY HANDLING AND USAGE ..................................................................................... 9
TECHNICAL ALARM DESCRIPTION ................................................................................. 10
TROUBLESHOOTING .......................................................................................................... 10
CARE AND MAINTENANCE ................................................................................................ 12
WARRANTY INFORMATION ................................................................................................ 12
EXPLANATION OF SYMBOLS ........................................................................................... 13
IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................... 14
OTHER STANDARDS AND COMPLIANCES ........................................................................ 15
ELECTROMAGNETIC COMPATIBILITY INFORMATION ................................................... 15
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INTRODUCTION
Thank you for selecting the BPM1AE. The BPM1AE is a fully automatic
arm cuff blood pressure monitor that uses the oscillometric principle
to measure your blood pressure and pulse rate. The monitor can transmit
your measurements to iHealth cloud when it connected with wifi.
PACKAGE CONTENTS
• 1 Blood Pressure Monitor
• 1 Owner’s Manual
• 1 Cuff
• 1 Charging Cable
INTENDED USE
The BPM1AE(Electronic Sphygmomanometer) is intended for use in a
professional setting or at home and is a non-invasive blood pressure
measurement system. It is designed to measure the systolic and diastolic
blood pressures and pulse rate of an adult individual by using a
technique in which an inflatable cuff is wrapped around the upper arm.
The measurement range of the cuff circumference is 8.6” to18.9’
(22cm-48cm)
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
The World Health Organization (WHO) has created the following guide
for assessing high blood pressure (without regard to 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 chart is not intended to provide a basis for any type of
emergency condition or diagnosis based on the color scheme; this chart
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only depicts different classifications of blood pressure. Consult your
physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this
Blood Pressure Monitor.
PARTS AND DISPLAY INDICATORS
SETUP AND OPERATING PROCEDURES
Download The Free iHealth App
Prior to first use, download and install the iHealth App from the App Store(iOS device)
or Google Play(Android device). Use keyword search terms ”iHealth” , ”BPM1AE” or ”Blood
Pressure Monitor”.
Set Wi-Fi
Step 1: Press and hold the user2 key for 10s, the monitor will display
“Open MyVitals App, ready to connect”.
Step 2: Launch the App and set the Wi-Fi linking of BPM1AE with App
guidance.
Step 3: If the monitor connects with router, the monitor will
display ”Success at once, just a moment… ”.
Step 4: If the monitor connects to cloud, the monitor will display
“Wi-Fi setting is success, if the App reminder over time, please
reopen the App”. Then Wi-Fi set done.
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If Wi-FI set done, the monitor will connect to cloud at 2 hour
intervals. If new version software release the monitor will updata
automatic when it connect to cloud.
The monitor can sync clock with cloud automatic when it connect to
cloud.
OPERATING PROCEDURES
Connecting The Cuff To The Monitor
Insert the cuff tubing connector into the air port in the side
of the monitor. Make sure that the connector
is completely inserted to avoid air leakage
during blood pressure measurements.
Avoid
compression or restriction of the
connection tubing during measurement，
which may cause inflation error, or harmful injury due to
continuous cuff pressure.
When the monitor in turn off mode, insert the cuff tubing
connector the monitor will turn on.
Apply The Cuff
a. Pull the cuff end through the
metal loop, positioning it
outward (away from your body).
b. Place a bare arm through the cuff
and position the cuff 1/2“(1-2 cm)
above the elbow joint.
c. Tighten the cuff and close it by
pulling it towards your body, securing it closed with the Velcro
fastener.
d. While seated, place your hand palm-side up in front of you on
a flat surface such as a desk or table. Position the rubber tube
in the middle of your arm aligned with your middle finger.
e. The cuff should fit comfortably, yet snugly around your arm.
You should be able to insert one finger between your arm and
the cuff.
Remember to:
1. Make sure that the appropriate cuff size is used; refer to
the cuff circumference range in “SPECIFICATIONS”.
2. Measure on the same arm each time.
3. Stay still during measurement. Do not move your arm, body,
or the monitor.
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4. Stay still and calm for one to one and half minutes before
taking a blood pressure measurement.
5. Keep the cuff clean. Cleaning the cuff after every 200 times
of usage is recommended.
If the cuff becomes dirty, clean it with a moistened cloth.
Do not rinse the monitor or cuff with running water.
Body Posture
Sitting Comfortably During Measurement
a. Be seated with your feet flat on the floor without crossing your
legs.
b. Place your hand palm-side up in front of you on a flat surface
such as a desk or table.
c. The middle of the cuff should be at the level of the right atrium
of your heart.
Lying Down During Measurement
a. Lie on your back.
b. Place your arm straight along your side with your hand palm-side
up.
c. The cuff should be placed at the same level as your heart.
Note:
Blood pressure can be affected by the position of the cuff and
your physiologic condition.
OPERATION INSTRUCTIONS
a. After applying the cuff and your body is in a comfortable
position, press user1 key or user2 key the the monitor will turn
on and display “While measuring, please relax”. Then the monitor
starts to seek zero pressure. If the cuff doesn’t connect with
the monitor, press any key the door temperature, outdoor
tempetature(if Wi-Fi set done) ,the battery valume and clock(if
Wi-Fi set done) will display on monitor for 3 seconds, Then the
monitor will turn off automatically.
b. Then the cuff will be slowly inflated. The blood pressure and
pulse will be measured during inflation. Inflation will stop
as soon as the blood pressure and pulse rate have been calculated
and displayed on the screen. The result will automatically be
stored in the Memory bank of the monitor. If memory is stored
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in the current memory group, the machine will show the
difference between the current measurement results and the
latest measurement. If the monitor connect to cloud, the
measurements will be transmit to cloud automatically.
c. If the monitor connect to cloud and download the outdoor remind,
press any key the monitor will display the outdoor remind,
otherwise press any key the monitor will turn off.
d. After measurement, the monitor will turn off automatically
after 1 minute of no operation.
e. During measurement, you can press the any key to turn off the
monitor manually.
Important: Please consult a healthcare professional for interpretation
of blood pressure measurements
SPECIFICATIONS
1. Product name: Blood Pressure Monitor
2. Model: BPM1AE
3. Classification: Internally powered, Type BF applied part, IP20, No
AP or APG, Continuous operation
4. Machine size: approx. 4.7” x 4.6” x 2.0”(119mm × 118mm × 51mm)
5. Cuff circumference: 8.6’’-11.8’’(22cm-30cm),
11.8’’-16.5’’(30cm-42cm) (Optional), 16.5’’-18.9’’(42cm-48cm)
(Optional))
6. Weight: approx. 12.3oz (350g) (excluding cuff)
7. Measuring method: Oscillometric method, automatic inflation and
measurement
8. Memory volume: 2*1000 times with time and date stamp
9. Power: DC:5V 1.0A,
Battery: 1*3.7V Li-ion 2200mAh
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
11. Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
12. Wireless communication:
Wi-Fi: IEEE802.b/g/n
13. Environmental temperature for operation: 10Ԩ～40Ԩ(50Ԭ～104Ԭ)
14. Environmental humidity for operation: ≤85%RH
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15. Environmental temperature for storage and transport: -20Ԩ～
50Ԩ(-4Ԭ～122Ԭ)
16. Environmental humidity for storage and transport: ≤85%RH
17. Environmental pressure: 80kPa-105kPa
18. Battery life: more than 180 measurements on a full charge
19. The blood pressure measurement system includes accessories, pump,
valve, cuff, and sensor.
Note: These specifications are subject to change without notice.
GENERAL SAFETY AND PRECAUTIONS
1. Read all of the information in the Owner’s Manual and other provided
instructions before operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure
measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements
to allow the blood circulation in your arm to recover. Prolonged
over-inflation (cuff pressure exceed 300 mmHg or maintained above15
mmHg for longer than 3 minutes) of the bladder may cause ecchymoma
of your arm.
7. Consult your physician for any of the following situations:
a) The application of the cuff over a wound or inflamed area
b) The application of the cuff on any limb with intravascular access
or therapy, or an arterio-venous (A-V) shunt
c) The application of the cuff on the arm on the side of a mastectomy
d) Simultaneous use with other medical monitoring equipment on the
same limb
e) The blood circulation of the user needs to be checked
8. This Blood Pressure Monitor is designed for adults and should never
be used on infants, young children, pregnant or pre-eclamptic
patients. Consult your physician before use on children.
9. Do not use this product in a moving vehicle as this may result in
inaccurate measurements.
10. Blood pressure measurements determined by this product are
equivalent to those obtained by professional healthcare
practitioners using the cuff/stethoscope auscultation method within
the limits prescribed by the American National Standard, Electronic
or Automated Sphygmomanometer.
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11. Information regarding potential electromagnetic or other
interference between the blood pressure monitor and other devices
together with advice regarding avoidance of such interference,
please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is
suggested that the blood pressure monitor be kept 10 meters away from
other wireless devices, such as WLAN unit, cell phone, microwave oven,
etc.
12. If Irregular Heartbeat (IHB) is detected during the measurement
procedure, the IHB symbol will be displayed. Under this condition,
the Blood Pressure Monitor can keep functioning, but the results may
be inaccurate. Please consult your physician for accurate
assessment.
There are 2 conditions under which the signal of IHB will be displayed:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period ≥0.14s and the number
of such pulse takes more than 53 percent of the total number of pulses.
13. Please do not use any other cuff other than that supplied by the
manufacturer as this may result in measurement errors and a
biocompatible hazard.
14. This product might not meet its performance specifications if
stored or used outside the specified temperature and humidity ranges.
15. Please do not share the cuff with any infectious person to avoid
cross-infection.
16. This product should not be used as a USB device.
17. If the determined blood pressure (systolic or diastolic) is
outside the rated range specified in part SPECIFICATIONS, the app
will immediately display a technical alarm on screen. In this case,
consult a physician or ensure that proper measurement procedures are
followed. The technical alarm is preset in the factory and cannot
be adjusted or inactivated. This technical alarm is assigned as low
priority according to IEC 60601-1-8.The technical alarm is
non-latching and does not need to be reset.
18. A medical AC adapter with an output of DC 5.0V and complies with
IEC 60601-1/UL 60601-1 and IEC 60601-1-2/EN 60601-1-2 is suitable
for this monitor. Please note that the monitor jack size is USB
micro-B.
19. Use of Charging Cable other than those specified or provided by
the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
20. Measurements are not possible in patients with a high frequency
of arrhythmias.
21. The device is not intended for use on neonates, children or
pregnant women. (Clinical testing has not been conducted on neonates,
children or pregnant women.)
22. Motion, trembling, shivering may affect the measurement reading.
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23. The device would not apply to the patients with poor peripheral
circulation, noticeably low blood pressure, or low body temperature
(there will be low blood flow to the measurement position).
24. The device would not apply to the patients who use an artificial
heart and lung (there will be no pulse)
25. Consult your physician before using the device for any of the
following conditions: common arrhythmias such as atrial or
ventricular premature beats or atrial fibrillation, arterial
sclerosis, poor perfusion, diabetes, pre-eclampsia, enal diseases.
26. The patient can be an intended operator.
BATTERY HANDLING AND USAGE
Do not change the battery. If the battery can no longer be charged,
please contact Customer Service.
• When charging is needed, please connect the monitor to a power
source. The monitor can work normally while charging.
• If the cuff doesn’t connect with the monitor, press any key the
door temperature, outdoor tempetature(if Wi-Fi set done) ,the
battery valume and clock(if Wi-Fi set done) will display on monitor.
If the power is less than 20%(the battery valume indication only
display a battery symbol ), please charge the battery. The monitor
will not work until the battery has enough power.
• When you charge the monitor, the monitor will display with
different indicator indicating the charging status. See the table
below for details.
• It is suggested that you charge the battery when the battery is
less than 25%. Overcharging the battery may reduce its lifetime.
Lithium battery replacement by inadequately trained personnel
could result in a hazard such as a fire or explosion.
Do not plug or unplug the power cord into the electrical outlet
with wet hands.
If the AC adapter is abnormal, please change the adapter.
Do not pull out the adapter when you are using the monitor.
Do not use any other type of AC adapter as it may harm the monitor.
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The monitor, cable, battery and cuff must be disposed of
according to local regulations at the end of their usage.
Note
：
The battery has limited charge cycles and may eventually
need to replaced by an iHealth service provider. Battery life
and charge cycles vary by use and settings.
Monitor
Status
Status Indicator
Charging dynamical battery symbol
Fully
charged
full battery symbol
Low battery empty battery symbol and reminder”Low battery
unable to perform measurement, please
recharge”
TECHNICAL ALARM DESCRIPTION
The monitor will show 'SYS or DIA beyond measurement range' or
' SYS or DIA below measurement range'' as technical alarm on screen
with no delay if the determined blood pressure (systolic or
diastolic) is outside the rated range specified in part
SPECIFICACIONS. In this case, you should consult a physician or
check if your operation violated the instructions.
The technical alarm condition (outside the rated range) is preset
in the factory and cannot be adjusted or inactivated. This alarm
condition is assigned as low priority according to IEC 60601-1-8.
The technical alarm is non-latching and need no reset. The signal
displayed on screen will disappear automatically after about 8
seconds.
TROUBLESHOOTING
PROBLEM POSSIBLE CAUSE SOLUTION
Low Battery Battery is less
than 20% Charge the battery
Display reads
“ERR xxx”
Blood pressure is
outside of
measurement range
Retest, make sure your
blood pressure is within
measurement range
A
rm or monitor was
moved during test
Retest, make sure not to
move your arm or the
monitor
T
he cuff does not
inflate properly
or pressure falls
quickly during
test
Review the cuff
appliz
c
ation instructions
and retest
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The cuff was not
properly applied
o
r the rubber tube
was bent or
pressed
Review the cuff
application instructions
and retest
Display reads an
abnormal result
T
he cuff position
was not correct or
it was not
properly
tightened.
Review the cuff
s
upplication instructions
and retest.
Body posture was
n
ot correct during
testing
Review body posture
instructions and retest
Speaking, moving
a
rm or body, being
a
ngry, excited or
nervous during
test
Retest when calm; avoid
speaking or movement
during the test
No response Incorrect
operation or
strong
electromagnetic
interference
Press the user2 key about
10 seconds to reset the
d
evice, relaunch app, and
reconnect the iOS device
to the monitor
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CARE AND MAINTENANCE
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and direct sunlight. Do not immerse the
monitor in water as this will result in damage to the monitor.
3. If this monitor is stored near freezing temperatures, allow it to
acclimate to room temperature before use.
4. Do not attempt to disassemble this monitor.
5. If the monitor is not used for a long time, please sure to fully
charge it every month.
6. It is recommended that product performance be checked every 2 years
or after each repair. Please contact the service center.
7. No monitor component needs to be maintained by the user. The circuit
diagrams, component part lists, descriptions, calibration
instructions, or other information which will assist the user’s
appropriately qualified technical personnel to repair those parts
of the equipment which are designated for repair can be supplied.
8. Clean the monitor with a dry, soft cloth or a moistened and well
wrung soft cloth using water, diluted disinfectant alcohol, or
diluted detergent
9. The monitor can maintain the safety and performance characteristics
for a minimum of 10,000 measurements or three years of usage,and
the cuff integrity is maintained after 1,000 open–close cycles of
the closure.
10. The battery can maintain the performance characteristics for a
minimum of 300 charge cycles. Battery replacement should only be
performed by a qualified iHealth technician. To do otherwise will
void your warranty and possibly damage your unit.
11. Cuff replacement should only be performed by a qualified iHealth
technician. To do otherwise will possibly damage your unit.
12. It is recommended that if the cuff is used, for example, in a
hospital or a clinic, it be disinfected twice a week. Wipe the inner
side (the side that contacts skin) of the cuff with a soft cloth
lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
WARRANTY INFORMATION
The Blood Pressure Monitor is warranted to be free from defects in
materials and workmanship within one year from the date of purchase
when used in accordance with the provided instructions. The warranty
extends only to the end user. We will, at our option, repair or replace
without charge the Blood Pressure Monitor covered by the warranty.
Repair or replacement is our only responsibility and your only remedy
under the warranty.
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EC REP
EXPLANATION OF SYMBOLS
Symbol for ”THE OPERATION GUIDE MUST BE READ”
The sign background color: blue.
The sign graphical symbol: white.
Symbol for “WARNING”
Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied
part)
Symbol for “ENVIRONMENT PROTECTION – Waste electrical products
should not be disposed of with household waste. Please recycle
where facilities exist. Check with your local authority or
retailer for recycling advice”.
Symbol for “MANUFACTURER”
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”
Symbol for“ DATE OF MANUFACTURE”
Symbol for “SERIAL NUMBER”
Symbol for “EUROPEAN REPRESENTATIVE”
Symbol for “KEEP DRY”
iHealth is a trademark of iHealth Labs Inc.
Manufactured for iHealth Labs Inc.
719 N. Shoreline Blvd., Mountain View, CA 94043, USA
1-855-816-7705
www.ihealthlabs.com
iHealthLabs Europe SARL
3 rue Tronchet, 75008, Paris, France
support@ihealthlabs.eu www.ihealthlabs.eu
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin
300190, China
EC REP
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Tel: 86-22-60526161
IMPORTANT INFORMATION REQUIRED BY THE FCC
This device complies with Part 15 of the FCC Rules. Its operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by iHealth Labs Inc.
would void the user’s authority to operate the product.
NOTE: This product has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This product
generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this product does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one
or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
The SAR limit of USA (FCC) is 1.6 W/kg averaged over one gram of tissue. Device has also been tested
against this SAR limit.
IC NOTICE
The SAR limit of Canada (IC) is 1.6 W/kg averaged over one gram of tissue. Device has
also been tested against this SAR limit.
This Class B digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
This product complies with Industry Canada. IC: RSS-247
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
subject to the following two conditions:
(1)this device may not cause interference, and
(2)this device must accept any interference, including interference that may cause
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undesired operation of the device.
This product is approved in accordance to R&TTE directive transmitter.
Hereby, [iHealth Labs Inc],declares that this BPM1AE is in compliance
with the essential requirements and other relevant provisions of
Directive 1999/5/EC. Directive 1999/5/EC declaration of conformity can
be downloaded on the following link:
https://www.ihealthlabs.eu/support/certifications
Ce produit est conforme à l'Industry Canada. IC: RSS-247
DECLARATION IC
Le présent appareil est conforme aux CNR d'Industrie Canada applicablesaux appareils ra
dio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes :
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le br
ouillage est susceptible d'en compromettre lefonctionnement.
Ce produit a été approuvé conformément au directives R&TTE de l'émetteur.
Par la présente, [iHealth Labs Inc.] déclare que l’appareil [BPM1AE] est conforme aux
exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE. La
déclaration de conformité, les documents réglementaires et certifications iHealth peuvent
être consultés via ce lien : https://www.ihealthlabs.eu/support/certifications
OTHER STANDARDS AND COMPLIANCES
The Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005 +A1:2012(E)/EN 60601-1：2006/A11: 2011 (Medical
electrical equipment -- Part 1: General requirements for basic safety
and essential performance), IEC 60601-1-2:2014(Medical electrical
equipment -- Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1：
2013/EN 80601-2-30:2010/A1：2015(Medical electrical equipment –Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers)EN 1060-1:
1995 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General
requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive
sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
This product is applicable to the equipment and system requirements
for the purpose of receiving radio frequency energy for the purpose
of the work, Wi-Fi receive bandwidth 22M. This product can also be used
to include RF transmitter equipment and system requirements and
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emission frequency of 2.4GHz ISM band, Wi-Fi modulation types:
DBPSK/DQPSK/CCK (DSSS) BPSK/QPSK/16QAM/64QAM (OFDM) , effective
radiated power: < 20dBm
Table 1 - Emission
Phenomenon Compliance Electromagnetic environment
RF emissions
CISPR 11
Group 1, Class
B
Home healthcare environment
Harmonic
distortion IEC 61000-3-2
Class A Home healthcare environment
Voltage
fluctuations and
flicker
IEC 61000-3-3
Compliance Home healthcare environment
Table 2 - Enclosure Port
Phenomenon Basic EMC
standard Immunity test levels
Home Healthcare Environment
Electrostatic
Discharge IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM
field
IEC 61000-4-3
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
Refer to table 3
Rated power
frequency
magnetic fields
IEC 61000-4-8 30A/m
50Hz or 60Hz
Table 3 – Proximity fields from RF wireless communications
equipment
Test frequency
(MHz) Band
(MHz) Immunity test levels
Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470
FM, ±5kHz deviation, 1kHz sine, 28V/m
710 704-787 Pulse modulation 217Hz, 9V/m
745
780
810 800-960 Pulse modulation 18Hz, 28V/m
870
17
930
1720 1700-1990 Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240 5100-5800 Pulse modulation 217Hz, 9V/m
5500
5785
Table 4 – Input a.c. power Port
Phenomenon Basic EMC
standard Immunity test levels
Home Healthcare Environment
Electrical fast
transients/burst IEC 61000-4-4
±2 kV
100kHz repetition frequency
Surges
Line-to-line IEC 61000-4-5
±0.5 kV, ±1 kV
Surges
Line-to-ground IEC 61000-4-5
±0.5 kV, ±1 kV, ±2 kV
Conducted
disturbances
induced by RF
fields
IEC 61000-4-6 3V, 0.15MHz-80MHz
6V in ISM and amateur radio bands between
0.15MHz and 80MHz
80%AM at 1kHz
Voltage dips IEC 61000-4-11 0% UT; 0.5 cycle
At 0º, 45º, 90º, 135º, 180º, 225º, 270º and
315º
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0º
Voltage
interruptions IEC 61000-4-11 0% UT; 250/300 cycles
Date of issue:Jul 15,2016
BPM1AE-SMSY01 V1.0