iHealth Labs ABP100 iHealth CardioMed User Manual

Download:
Mirror Download [FCC.gov]
Document ID	3792252
Application ID	auze6A3SQRbq5NzENHTonw==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	27.6kB (344974 bits)
Date Submitted	2018-03-22 00:00:00
Date Available	2018-03-22 00:00:00
Creation Date	2018-03-21 09:15:29
Producing Software	Acrobat Distiller 7.0 (Windows)
Document Lastmod	2018-03-21 09:15:29
Document Title	Microsoft Word - ABPM_user_guide说明书_V1_2017-11-10（统一ihealth cardiomed 更改下行字体 2018-3-21）.doc
Document Creator	PScript5.dll Version 5.2
Document Author:	00323

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
1 / 16
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:
Identifying white-coat hypertension phenomena
Identifying masked hypertension phenomena
Identifying abnormal 24-h BP patterns
‹
Daytime hypertension
‹
Siesta dipping / post-prandial
‹
Nocturnal hypertension
‹
Dipping status/isolated nocturnal hypertension
hypotension
Assessment of treatment
‹
Assessing 24-h BP control
‹
Identifying true resistant hypertension
Assessing morning hypertension and morning BP surge
Screening and follow up of obstructive sleep apnoea
Assessing increased BP variability
Assessing hypertension in the elderly
Assessing hypertension in high-risk patients
Identifying ambulatory hypotension
Identifying BP patterns in Parkinson’s disease
Assessing 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.
2 / 16
Contraindication
Measurements are not possible in patients with a high frequency of arrhythmias
Do not apply the device to patients with sickle cell disease or patients who have or are expected to develop skin
lesions.
The 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.
Do not apply the device to patients with coagulation disturbances.
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).
Warning
Read all of the information in the User Guide and other provided instructions before operating the unit.
Consult 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.
Do not use this product in a moving vehicle as this may result in inaccurate measurements.
If 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.
This product should not be used as a USB device.
If 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.
This 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.
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.
Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate
measurements.
The device would not apply to the patients who use an artificial heart and lung (there will be no pulse)
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, renal diseases, secondary hypertension caused by other diseases.
3 / 16
z
Whether 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.
Whether 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.
The device should not be exposed to strong electromagnetic fields, otherwise they may cause inaccurate results
or malfunction.
Do not use the device in combination with high-frequency(HF) surgical equipment.
Do not use the device in the presence of flammable anaesthetics due to risk of explosion.
The 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.
Do 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.
The cuff must not be placed on the area with dermatitis, open wounds and other contraindications. Please
consult a physician for specific situation.
Caution
Motion, trembling, shivering may affect the measurement reading.
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.
For 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.
The 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.
It 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.
Choose the appropriate cuff according to the arm circumference. The arm circumference outside the applicable
scope of the cuff may lead to inaccurate results.
Cuff 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.
When the cuff is placed over thick clothing may result in inaccurate readings.
Relax 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.
Do 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.
Please check measurement values by other methods (e.g. auscultation), if you suspect an value.
To prevent electric shock hazard due to leakage current, only use the power supplies which are compliant with
the technical specifications of the device.
The equipment must never be connected to a printer, computer or other external equipment while still fitted to
the patient.
4 / 16
z
The 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.
If the patient experience arm numbness or pain during the measurement, they should switch off the device
immediately and take off the cuff.
In some patients petechiae, haemorrhages or subcutaneous haematomas may occur. Please consult a
physician for specific situation.
Some patients may be allergic caused by the material of the cuff. Please consult a physician for specific
situation.
It 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.).
This product might not meet its performance specifications if stored or used outside the specified temperature
and humidity ranges.
Please 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
5 / 16
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
Charge 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.
The 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.
The monitor will not work until the battery has enough power.
When the monitor needs charging, please connect the monitor to a power source.
You should charge the battery when the battery is less than 25% charged. Overcharging the battery may reduce
its lifetime.
6 / 16
z
When 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.
7 / 16
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.
8 / 16
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.
9 / 16
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
Pressure
Retest, make sure not to move
“Er0”
before measurement
system
is
unstable
your arm or the monitor
10 / 16
LED display reads
“Er1”
LED display reads
“Er2”
Fail to detect systolic pressure
Fail to detect diastolic pressure
LED display reads
Pneumatic system blocked or cuff
“Er3”
is too tight during inflation
Apply the cuff correctly and try
LED display reads
Pneumatic system leakage or cuff
again
“Er4”
is too loose during inflation
LED display reads
“Er5”
Cuff pressure above 300mmHg
LED display reads
More than 160 seconds with cuff
“Er6”
pressure above 15 mmHg
LED display reads
“Er7”
LED display reads
“Er8”
LED display reads
“ErA”
LED display reads
“ Er”
Measure
again
after
five
minutes. If the monitor is still
memory accessing error
abnormal, please contact the
Device parameter checking error
local distributor or the factory.
Pressure sensor parameter error
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.
The cuff position was not correct
or it was not
LED display reads
an abnormal
result
Review
the
cuff
application
instructions and retest
properly tightened
Body posture was not correct
Review
body
during testing
instructions and retest
Speaking, moving arm or body,
Retest
being angry,
speaking or movement during
excited or nervous during test
the test
when
posture
calm;
avoid
Reset iOS device. Reset monitor
connection
Bluetooth
Bluetooth
unsuccessful, monitor is
connection
abnormal,
unstable
electromagnetic interference
or
strong
is present
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
Incorrect
operation
or
you press button
electromagneticinterference
11 / 16
strong
Press the
button and hold
for about 10seconds to reset the
device.
CARE AND MAINTENANCE
Strictly in accordance with product instructions to maintain and clean the device.
If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
If the monitor is not used for a long time, please be sure to fully charge it every month.
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.
Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water, diluted disinfectant
alcohol, or diluted detergent.
The 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.
The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
It 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.
It is recommended that product performance be checked every 2 years or after each repair. Please contact the
customer service.
Do 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.
The 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.
It 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)
12 / 16
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:+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, YaAn Road, Nankai District, Tianjin 300190, China.
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 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
13 / 16
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);
14 / 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
RF emissions
Harmonic distortion
Voltage fluctuations
and flicker
Compliance
CISPR 11
Group 1, Class B
IEC 61000-3-2
Class A
IEC 61000-3-3
Compliance
Electromagnetic environment
Home healthcare environment
Home healthcare environment
Home healthcare environment
Table 2 - Enclosure Port
Phenomenon
Electrostatic
Discharge
Radiated RF
field
Basic
EMC
standard
IEC 61000-4-2
EM
IEC 61000-4-3
Proximity fields from
RF
wireless
communications
equipment
Rated
power
frequency magnetic
fields
IEC 61000-4-3
Table 3 –
IEC 61000-4-8
Immunity test levels
Home Healthcare Environment
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Refer to table 3
30A/m
50Hz or 60Hz
Proximity fields from RF wireless communications
equipment
Test frequency
(MHz)
385
450
710
745
780
810
Band
(MHz)
380-390
430-470
704-787
Immunity test levels
Professional healthcare facility environment
Pulse modulation 18Hz, 27V/m
FM, ±5kHz deviation, 1kHz sine, 28V/m
Pulse modulation 217Hz, 9V/m
800-960
Pulse modulation 18Hz, 28V/m
15 / 16
870
930
1720
1845
1970
2450
5240
5500
5785
1700-1990
Pulse modulation 217Hz, 28V/m
2400-2570
5100-5800
Pulse modulation 217Hz, 28V/m
Pulse modulation 217Hz, 9V/m
Table 4 – Input a.c. power Port
Phenomenon
Electrical
fast
transients/burst
Surges
Line-to-line
Surges
Line-to-ground
Conducted
disturbances
induced by RF fields
Basic
EMC
standard
IEC 61000-4-4
Immunity test levels
Home Healthcare Environment
IEC 61000-4-5
±2 kV
100kHz repetition frequency
±0.5 kV, ±1 kV
IEC 61000-4-5
±0.5 kV, ±1 kV, ±2 kV
IEC 61000-4-6
3V, 0.15MHz-80MHz
6V in ISM and amateur radio bands between
0.15MHz and 80MHz
80%AM at 1kHz
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
0% UT; 250/300 cycles
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Date of issue:Sep25,2017
ABP100-SMSY01 V1.0
16 / 16

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : No
XMP Toolkit                     : 3.1-701
Producer                        : Acrobat Distiller 7.0 (Windows)
Create Date                     : 2018:03:21 09:15:29+08:00
Creator Tool                    : PScript5.dll Version 5.2
Modify Date                     : 2018:03:21 09:15:29+08:00
Format                          : application/pdf
Creator                         : 00323
Title                           : Microsoft Word - ABPM_user_guide说明书_V1_2017-11-10（统一ihealth cardiomed 更改下行字体 2018-3-21）.doc
Document ID                     : uuid:3a3e54d5-136b-4cc0-afe0-dd489ae043d0
Instance ID                     : uuid:05092c63-3aac-4256-b6c7-d643a6dde63b
Page Count                      : 16
Author                          : 00323

EXIF Metadata provided by EXIF.tools