iHealth CardioMed User manual

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iHealth® CardioMed
Ambulatory Blood Pressure Monitor (ABP100)
USER GUIDE
Table of Contents
Introduction to Ambulatory Blood Pressure Monitoring ............................................................2
Indication .........................................................................................................................................2
Package Contents ..........................................................................................................................2
Intended Use...................................................................................................................................2
Contraindication..............................................................................................................................3 
Warning............................................................................................................................................3
Caution..............................................................................................................................................4
PARTS AND DISPLAY INDICATORS .........................................................................................5
SPECIFICATIONS..........................................................................................................................5
SET UP REQUIREMENTS ...........................................................................................................6
BATTERY HANDLING AND USAGE...........................................................................................6
SET UP PROCEDURES ...............................................................................................................7
ABPM SYNC AND SETUP ...........................................................................................................7
MEASUREMENT PROCEDURES ..............................................................................................8
TAKING YOUR BLOOD PRESSURE READING ......................................................................9
TAKING YOUR BLOOD PRESSURE READING MANUALLY................................................9
TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY...................................10
BLOOD PRESSURE CLASSIFICATION FOR ADULTS ........................................................10
TROUBLESHOOTING ................................................................................................................10
CARE AND MAINTENANCE ......................................................................................................12
WARRANTY INFORMATION .....................................................................................................12
EXPLANATION OF SYMBOLS..................................................................................................12
IMPORTANT INFORMATION REQUIRED BY THE FCC ......................................................13
OTHER STANDARDS AND COMPLIANCES..........................................................................14
ELECTROMAGNETIC COMPATIBILITY INFORMATION .....................................................15

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Introduction to Ambulatory Blood Pressure Monitoring
Thank you for selecting the iHealth CardioMed Ambulatory Blood Pressure Monitoring. Ambulatory blood pressure
monitoring (ABPM) is to allow subjects to wear an ambulatory blood pressure recording device for normal daily
activities and sleep, the instrument will automatically set blood pressure measurements at intervals, recording 24h.
Within the blood pressure data to provide valuable information to understand the level and trend of the patient's blood
pressure fluctuations throughout the day.
Indication
The data obtained from ambulatory blood pressure monitors is accurate and useful for managing a wide variety of
hypertensive situations including:
zIdentifying white-coat hypertension phenomena
zIdentifying masked hypertension phenomena
zIdentifying abnormal 24-h BP patterns
Daytime hypertension
Siesta dipping / post-prandial hypotension
Nocturnal hypertension
Dipping status/isolated nocturnal hypertension
zAssessment of treatment
Assessing 24-h BP control
Identifying true resistant hypertension
zAssessing morning hypertension and morning BP surge
zScreening and follow up of obstructive sleep apnoea
zAssessing increased BP variability
zAssessing hypertension in the elderly
zAssessing hypertension in high-risk patients
zIdentifying ambulatory hypotension
zIdentifying BP patterns in Parkinson’s disease
zAssessing endocrine hypertension
Package Contents
* 1 iHealth CardioMed Ambulatory Blood Pressure Monitoring
* 2 Cuffs
* 1 User Guide
* 1 Quick Start Guide
* 1 Charging Cable
Intended Use
The iHealth CardioMed Ambulatory Blood Pressure Monitor is a non-invasive blood pressure measurement system
that is intended to be worked with your mobile devices for the recording and displaying of up to 500 measurements of
systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and
treatment when it is necessary to measure an adult (> 12yrs.) patient's systolic and diastolic blood pressures over an
extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

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Contraindication
zMeasurements are not possible in patients with a high frequency of arrhythmias
zDo not apply the device to patients with sickle cell disease or patients who have or are expected to develop skin
lesions.
zThe device is not intended for use on pregnant women, neonates and children. The security and effectiveness of
the device has not been validated on pregnant women, neonates and children.
zDo not apply the device to patients with coagulation disturbances.
zThe 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).
Warning
zRead all of the information in the User Guide and other provided instructions before operating the unit.
zConsult your physician for any of the following situations:
a)The application of the cuff on any limb with intravascular access or therapy, or an arteriovenous(A-V)
shunt.
b) The application of the cuff on the arm on the side of a mastectomy.
c) Simultaneous use with other medical monitoring equipment on the same limb.
zDo not use this product in a moving vehicle as this may result in inaccurate measurements.
zIf an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed
in the iHealth APP. Under this condition, the Blood Pressure Monitor can keep functioning, but the results may
be inaccurate. Please consult your physician for accurate assessment.
The IHB symbol will be displayed under 2 conditions:
(1)The coefficient of variation (CV) of pulse period >25%.
(2)The difference of adjacent pulse period is ≥0.14s and more than 53 percent of the total number of
pulses readings falls within this definition.
zThis product should not be used as a USB device.
zIf the blood pressure measurement (systolic or diastolic) is outside the rated range specified inpart
SPECIFICATIONS, the monitor will immediately display a technical alarm on the LED screen. In this case,
repeat the measurement ensuring that the proper measurement procedures are followed and/or consult with
your medical professional. The technical alarm is preset in the factory and cannot be adjusted or inactivated.
This technical alarm is assigned as low priority according to IEC 60601-1-8. The technical alarm does not need
to be reset.
zThis device requires a medical AC adapter with an output of DC 5.0V that complies with IEC60601-1/UL
60601-1 and IEC 60601-1-2/EN 60601-1-2 such as FJ-SW328U0502000N(input:100-240V~, 50/60Hz, 0.4A
Max; output: DC 5V, 2.0A). Please note that the monitor jack size is USB micro B. The USB jack should be used
for charging only.
zUse 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.
zPlease do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate
measurements.
zThe device would not apply to the patients who use an artificial heart and lung (there will be no pulse)
zConsult 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, renal diseases, secondary hypertension caused by other diseases.

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zWhether applying the device to confused, dazed, unconscious or otherwise incapable patients need to consult a
physician. The device should be used only under supervision if the physician agrees.
zWhether applying the device to the patients with serious mobility impairments need to consult a physician. The
device should be used only under supervision if the physician agrees.
zThe device should not be exposed to strong electromagnetic fields, otherwise they may cause inaccurate results
or malfunction.
zDo not use the device in combination with high-frequency(HF) surgical equipment.
zDo not use the device in the presence of flammable anaesthetics due to risk of explosion.
zThe physician must be certain that, according to the health of the patient, the use of the device will not damage
blood circulation in the arm.
zDo not attach the cuff to a limb being used for intravenous infusions. This may cause the infusion to be blocked
and cause the patient harm.
zThe cuff must not be placed on the area with dermatitis, open wounds and other contraindications. Please
consult a physician for specific situation.
Caution
zMotion, trembling, shivering may affect the measurement reading.
zBlood 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.
zFor 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, microwave oven, etc.
zThe results of blood pressure measurements may be influenced by: the patient's physical condition, cuff
wrapping method, measuring posture, measuring environment etc. Strictly in accordance with product
instructions to operate the device, otherwise it may lead to inaccurate results.
zIt is recommended to apply the cuff to non-dominant arm. Choose the arm of the other side if there are blood
pressure measurement contraindications(e.g. there are open wounds or amputation on the area where the cuff
is wrapped) on the arm of one side. Please consult a physician for specific situation.
zChoose the appropriate cuff according to the arm circumference. The arm circumference outside the applicable
scope of the cuff may lead to inaccurate results.
zCuff wrapping method should be strictly in accordance with product instructions. Inappropriate cuff wrapping
location, cuff wrapping too loose or too tight, and other factors may lead to inaccurate results.
zWhen the cuff is placed over thick clothing may result in inaccurate readings.
zRelax and be quiet during measurement, avoid talking and movement. Avoid flexing the muscles or moving the
hand and fingers of the cuffed arm during the measurement.
zDo not use the device when it is exposed to mechanical vibration (e.g. in vehicles). Advise patient not to drive
but if this is necessary to stop if possible during measurement.
zPlease check measurement values by other methods (e.g. auscultation), if you suspect an value.
zTo prevent electric shock hazard due to leakage current, only use the power supplies which are compliant with
the technical specifications of the device.
zThe equipment must never be connected to a printer, computer or other external equipment while still fitted to
the patient.

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zThe physician should make the patient understand the whole measurement procedure and how to cope with the
device. Instruct patient how to switch off the device and take off the cuff, in case of malfunctioning and other
emergencies, such as repeated inflation.
zIf the patient experience arm numbness or pain during the measurement, they should switch off the device
immediately and take off the cuff.
zIn some patients petechiae, haemorrhages or subcutaneous haematomas may occur. Please consult a
physician for specific situation.
zSome patients may be allergic caused by the material of the cuff. Please consult a physician for specific
situation.
zIt is recommended that the patient record important events, such as take medicine(taking time, drug name, drug
dose etc.), awake and asleep periods, any symptoms(pain, dizziness etc.), any events which may influence
blood pressure values(after meals, taking a nap, smoking, watching matches, taking a car etc.).
zThis product might not meet its performance specifications if stored or used outside the specified temperature
and humidity ranges.
zPlease do not share the cuff with any infectious person to avoid cross-infection.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: iHealth CardioMed
2. Model: ABP100
3. Classification: Internally powered; Defibrillation-proof Type BF applied part; IP22, No AP or APG; Continuous
operation

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4. Machine size: approx. 5.57″x 2.38″x 0.75″(141.5mm×60.5mm×19mm)
5. Cuff circumference: 8.66″to 11.81″(22cm-30cm) and 11.81″to 16.54″(30cm-42cm)
6. Weight: approx.3.54 oz(110g)(excluding cuff)
7.Measuring method: Oscillometric method, automatic inflation and measurement
8.Memory volume: 500 times with time and date stamp
9. Power: DC:5.0V 2.0A, Battery: 1*3.7V Li-ion 950mAh
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:
Bluetooth V4.0
Frequency Band: 2.400-2.4835 GHz
13. Environmental temperature for operation: 5°C-40°C(41°F -104°F)
14. Environmental humidity for operation: ≤85%RH
15. Environmental temperature for storage and transport:-20°C-55°C(-4°F-131°F)
16. Environmental humidity for storage and transport: ≤90%RH
17. Environmental pressure: 80kPa-105kPa
18. Battery life: approx. 120 measurements on a full charge
19. The blood pressure measurement system includes accessories: pump, valve, cuff, LED screen and sensor.
Note: These specifications are subject to change without notice.
SET UP REQUIREMENTS
The iHealth CardioMed Ambulatory Blood Pressure Monitor is designed to be used with the following iPad models:
iPad Air+
iPad mini+
iPad 3+
Please note that the compatible devices are subject to change. For the latest compatibility list,
visitwww.ihealthlabs.com/support
BATTERY HANDLING AND USAGE
zCharge Battery before First Use
Connect the monitor to a USB port(Power: DC:5.0V 2.0A) using the charging cable provided until the
charging indicator steady.
zThe battery charge will be displayed on the LED screen after each measurement. And when the monitor is
connected to the iHealth APP, the battery charge will be displayed in the APP.
zThe monitor will not work until the battery has enough power.
zWhen the monitor needs charging, please connect the monitor to a power source.
zYou should charge the battery when the battery is less than 25% charged. Overcharging the battery may reduce
its lifetime.

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zWhen in charging mode, the charging status will be displayed on the LED screen. See the table below for
details.
Monitor Status Status Indicator
Charging battery/charge symbol flashing slow
Fully charged battery/charge symbol steady
Battery charge <25% battery/charge symbol flashing fast
Battery low battery/charge symbol flashing fast
Do not change the battery. If the battery can no longer be charged, please contact Customer Service.
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 use the monitor while charging.
Do not use any other type of AC adapter as it may harm the monitor.
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.
SET UP PROCEDURES
Download the Free iHealth App
Prior to first use, scan QR code and download the iHealth App. Follow the on-screen instructions to register and set up
your personal account.
Access the iHealth Cloud Account
Your iHealth account also gives you access to the secure iHealth cloud service.
Power on the Monitor
Connect the monitor to a USB port using the charging cable provided or press button at least 2 seconds until the
LED screen displays all characters to power on the monitor at the first use.
ABPM SYNC AND SETUP
Bluetooth Function
The Bluetooth function is always on if the monitor has enough power. Only if the monitor is in low power
status(not enough power to take blood pressure readings), the Bluetooth function will be turned off until the
monitor has charged and have enough power.
Connect to iOS Device via Bluetooth
a. Enable Bluetooth on your iOS device.
b. Launch the iHealth App from your iOS device.
c. When a successful connection has been established, the Bluetooth indicator light will light up.
d. When sync is processing, the sync indicator will flash , when sync is finished,
the sync indicator lights up for 2 seconds and then light off.

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Bluetooth connected Syncing Syncing Sync finished
SYNC TIME AND SETTINGS
Automatic mode is disabled before automatic test parameters are set. Using APP to configuration automatic mode
parameters. Time and date on the device will be automatically sync with your smart device when the Bluetooth
connection is established.
MEASUREMENT PROCEDURES
Blood pressure can be affected by the position of the cuff and your physiologic condition. It is very important that the
cuff should be placed at the same level as your heart.
Body Posture
Sitting Comfortably During Measurement
a. Relax and be quiet during measurement, avoid talking and movement.
b. When measuring in the standing position, let the cuffed arm hang relaxed, slightly away from the body.
c. When measuring in the sitting position, the arm should be supported at heart level.
d. Avoid flexing the muscles or moving the hand and fingers of the cuffed arm during the measurement
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.
Fitting a Patient with the ABPM Cuff
a. Pull the cuff end through the metal loop, positioning it outward (away from your patient body).
b. Place a bare arm through the cuff and position the cuff 1/2"(1-2cm) above the elbow joint.
c. Tighten the cuff 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.
When the left arm is measured, position the monitor in the middle of your arm so that it is aligned with your
middle finger.
When the right arm is measured, position the monitor in the middle of your arm so that it is aligned with your
middle finger, the “up and down” position is opposite.
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.

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Remember to:
1. Make sure that the appropriate cuff size is used; refer to the cuff circumference range in the Specifications section
of this manual.
2. Measure on the same arm each time.
3. Stay still during measurement. Do not move your arm, body or the monitor.
4. Stay still and calm for one to one and half minutes before taking a blood pressure measurement. Prolonged
over-inflation of the bladder may cause ecchymoma of your arm.
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.
Left arm measurement Right arm measurement
TAKING YOUR BLOOD PRESSURE READING
The iHealth CardioMed Ambulatory Blood Pressure Monitor has two measurement modes. Preparing your patient for
the ABPM study is the most important step to achieving a successful test.
TAKING YOUR BLOOD PRESSURE READING MANUALLY
a. Long press the button, the monitor will activate and all display characters
are shown for self-test. You can check the LED screen display according to the right
picture. Please contact the service center if symbol is missing.
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 be automatically stored in the
memory, and all results will be uploaded to the App automatically upon the next successful
Bluetooth connection.
b. During measurement, you can press the button or button to turn off
the monitor manually.
c. After measurement, the monitor will display SYS and DIA in first screen, and
then display pulse rate in 2 seconds or press any button, and turn off display in 2
seconds or press any button.
Note: Manual test readings taken before automatic mode is configured cannot be stored in memory.

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TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY
a. Long press the for at least 2 seconds to switch on or off the "Automatic
Mode", the monitor shows current automatic mode on the LED screen. If the
monitor has no automatic mode parameters, the monitor shows "- -" on the LED
monitor. If the monitor has finished the automatic test, the monitor shows "END" on
the LED monitor.
b. In the automatic mode, the LED screen is turned off by default. During the test,
short press any button to turn on the LED screen and it will last to the end of this
measurement.
c. When "Auto Mode" on ,while not in a measurement, short press any button to turn on the LED screen and
the LED screen shows the last measurement result.
d. When "Auto Mode" on, the monitor will continue take measurements in the
scheduled time, and after the monitor get enough readings, the monitor automatic
stop taking readings.
Note: Please consult a health care professional for interpretation of pressure
measurements.
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: Consult your physician for proper interpretation of blood pressure results.
TROUBLESHOOTING
PROBLEM POSSIBLE CAUSE SOLUTION
Low Battery Battery do not have enough power Charge the battery
LED display reads
“Er0”
Pressure system is unstable
before measurement
Retest, make sure not to move
your arm or the monitor

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LED display reads
“Er1” Fail to detect systolic pressure
LED display reads
“Er2” Fail to detect diastolic pressure
LED display reads
“Er3”
Pneumatic system blocked or cuff
is too tight during inflation Apply the cuff correctly and try
again
LED display reads
“Er4”
Pneumatic system leakage or cuff
is too loose during inflation
LED display reads
“Er5” Cuff pressure above 300mmHg
Measure again after five
minutes. If the monitor is still
abnormal, please contact the
local distributor or the factory.
LED display reads
“Er6”
More than 160 seconds with cuff
pressure above 15 mmHg
LED display reads
“Er7” memory accessing error
LED display reads
“Er8” Device parameter checking error
LED display reads
“ErA” Pressure sensor parameter error
LED display reads
“Er” Bluetooth communicate error
Reset monitor by pressing
the button and holding for
about 10 seconds, then connect
the mobile device correctly and
try again, If the monitor is still
abnormal, please contact the
local distributor or the factory.
LED display reads
an abnormal
result
The cuff position was not correct
or it was not
properly tightened
Review the cuff application
instructions and retest
Body posture was not correct
during testing
Review body posture
instructions and retest
Speaking, moving arm or body,
being angry,
excited or nervous during test
Retest when calm; avoid
speaking or movement during
the test
Bluetooth
connection
unstable
Bluetooth connection
unsuccessful, monitor is
abnormal, or strong
electromagnetic interference
is present
Reset iOS device. Reset monitor
by pressing the button and
holding for about 10 seconds.
Make sure the monitor and iOS
device are away from other
electrical equipment. Please see
Warning
No response when
you press button
Incorrect operation or strong
electromagneticinterference Press the button and hold

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for about 10seconds to reset the
device.
CARE AND MAINTENANCE
zStrictly in accordance with product instructions to maintain and clean the device.
zIf this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
zIf the monitor is not used for a long time, please be sure to fully charge it every month.
zNo 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.
zClean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water, diluted disinfectant
alcohol, or diluted detergent.
zThe monitor can maintain the safety and performance characteristics for a minimum of 30,000measurements or
three years of usage, and the cuff integrity is maintained after 1,000 open-close cycles.
zThe battery can maintain the performance characteristics for a minimum of 300 charge cycles.
zIt is recommended that if the cuff is used in a hospital or a clinic, it be disinfected twice a week. Wipe the inner
side (the side that contacts skin) of the cuff with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then
air dry the cuff.
zIt is recommended that product performance be checked every 2 years or after each repair. Please contact the
customer service.
zDo not use the device if you think it is damaged or if anything appears unusual. Please refer your device to
qualified service personnel of the manufacturers.
zThe monitor requires 6 hours to warm or cool from the minimum storage temperature between uses until the
monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
zIt may lead to inaccurate results or equipment failure if the device is stored or used outside the specified
temperature and humidity ranges.
Do not drop this monitor or subject it to strong impact.
Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this will result in damage to the
monitor.
Do not attempt to disassemble this monitor.
Battery replacement should only be performed by a qualified iHealth technician. To do otherwise will void your
warranty and possibly damage your unit.
Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise
will possibly damage your unit.
WARRANTY INFORMATION
The iHealth CardioMed Blood Pressure Monitor is warranted to be free from defects in materials and workmanship
within one year from the date of purchase when used in accordance with the provided instructions. The warranty
extends only to the end user. We will, at our option, repair or replace without charge the iHealth Next Blood Pressure
Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the
warranty.
EXPLANATION OF SYMBOLS
Symbol for "DEFIBRILLATION-PROOF TYPE BF APPLIED PARTS" (cuff only)

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Symbol for "THE OPERATION GUIDE MUST BE READ"
The sign background color: blue The sign graphical symbol: white
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 "WARNING"
Symbol for "MANUFACTURER"
Symbol for "EUROPEAN REPRESENTATIVE"
Symbol for "COMPILES WITH MDD93/42/EEC REQUIREMENTS"
IP22 The first characteristic numeral symbol for “Degrees of protection against access to hazardous parts and
against solid foreign objects “.The second characteristic numeral symbol for “Degrees of protection against ingress of
water”
iHealth is a trademark of iHealth Lab Inc.
iPad,iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
Manufactured for iHealth Lab Inc.
120 San Lucar Ct.,Sunnyvale, CA 94086, USA
Tel:[phone] www.ihealthlabs.com
iHealthLabs Europe SARL
3 Rue Tronchet,75008,Paris,France
[email protected] www.ihealthlabs.eu
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.
Tel: [phone]
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 this device must accept any interference received, including
interference that may cause undesired operation.
(2) Changes or modifications not expressly approved by iHealth Lab Inc. would void the user’s authority to operate the
product.
Note: This product has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This product generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular installation. If this product does cause harmful interference

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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.
Please take attention that changes or modification not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.
This product complies with Industry Canada. IC: RSS-210
IC NOTICE
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 undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radioexempts 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 brouillage est susceptible
d'en compromettre le fonctionnement.
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum
(or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users,
the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more
than that necessary for successful communication.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour l'émetteur par Industrie
Canada. Dans le but de réduire les risques de brouillage radioélectrique à l'intention des autres utilisateurs, il faut
choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas
l'intensité nécessaire à l'établissement d'une communication satisfaisante.
Hereby, [ANDON HEALTH CO., LTD.] declares that the equipment type [ABP100] is incompliance with Directive
2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address: www.ihealthlabs.eu
OTHER STANDARDS AND COMPLIANCES
The iHealth CardioMed Ambulatory Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance);
IEC 60601-1-2:2014/EN 60601-1-2:2007/AC:2010(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);

15/16
ISO81060-2 ：2013,(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement
Type).
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, Bluetooth receive bandwidth 2M. This product can also be used to include RF
transmitter equipment and system requirements and emission frequency of 2.4GHz ISM band, Bluetooth modulation
types:GFSK, effective radiated power: <4dBm.
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

16/16
870
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:Sep25,2017
ABP100-SMSY01 V1.0