iHealth Ease BP3L User manual

Smart Blood Pressure Monitor
Tensiomètre connecté
Sfigmomanometro intelligente
Tensiómetro inteligente
Vernetztes Blutdruckmessgerät
Monitor de tensão arterial inteligente
Slimme bloeddrukmeter
ﻲﻛذﻟا مدﻟا طﻐﺿ سﺎﯾﻗ زﺎﮭﺟ
Instruction For Use
Notice d’utilisation
Istruzioni per l'uso
Instrucciones de uso
Bedienungsanleitung
Instruções de utilização
Gebruiksinstructies
مادﺧﺗﺳﻻا تﺎﻣﯾﻠﻌﺗ

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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
EN
Air port
Emergency Stop Button and LED
Rubber tube cutubing Connector Cu
Ethyl alcohol (75-90%). Then air dry the cuff.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
1

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
2

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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
Monitor Status
Charging
Fully charged
Low battery
Abnormal state
Status Indicator
Flashing green light
Steady green light
Flashing red light (for a few seconds)
Steady red light
Ethyl alcohol (75-90%). Then air dry the cuff.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
3

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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
PROBLEM POSSIBLE CAUSE SOLUTION
Low Battery Battery is less than 25% Charge the battery
Display reads
“ERROR”
Blood pressure is outside of measurement range
Arm or monitor was moved during test
The cu does not inate properly or pressure falls
quickly during test
The cu was not properly applied
Display reads
an abnormal
result
Bluetooth
connection
unstable
No response Incorrect operation or strong electromagnetic interference
Press the button to reset the device and reconnect
the iOS/Android device to the monitor, re-launch app.
Re-test and contact your health professional if blood
pressure measurement is still outside of normal range
Re-test, make sure not to move your arm or the monitor
Review the cu application instructions and re-test
Review the cu application instructions and re-test
The cu position was not correct or it was not properly
tightened Review the cu application instructions and re-test
Body posture was not correct during testing Review body posture instructions and re-test
Speaking, moving arm or body, being angry, excited or
nervous during test
Re-test when calm; avoid speaking or moving
during the test
Bluetooth connection unsuccessful, monitor is
abnormal, or strong electromagnetic interference is
present
Restart iOS/Android device. Reset monitor by pressing
the button . Make sure the monitor and
iOS/Android device are away from other electrical
equipment. Please see GENERAL SAFETY AND
PRECAUTIONS
Ethyl alcohol (75-90%). Then air dry the cuff.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
4

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
EC REP
SN
5

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
Measurement Type)
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China
Tel: [phone]
EC REP
iHealthlabs Europe SAS
36 Rue de Ponthieu,75008, Paris, France
[email protected] www.ihealthlabs.eu
6

9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5%
10. Wireless communication: Bluetooth V4.0 BLE Only Mode Frequency Band: 2.402--2.480GHz
The Max of RF Output Power :Bluetooth Low Energy -0.5dBm
11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F)
12. Environmental humidity for operation: ≤85% RH
13. Environmental temperature for storage and transport:-20°C - 55°C (-4°F - 131°F)
14. Environmental humidity for storage and transport: ≤85% RH
15. Environmental pressure: 80kPa - 105kPa
16. Battery life: more than 500 measurements on a full charge, the battery can maintain the
performance characteristics for a minimum of 300 charge cycles
17. 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 User Guide and other provided instructions before operating the unit.
2. 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
arteriovenous (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.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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.
5. If you are using a smart phone to operate the device and a phone call comes in during the
measurement, the measurement process will be terminated automatically. It is thus recommended
that the phone be set in Airplane mode during measurement to avoid interrupting the measurement.
6. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Smart 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 sets of circumstances:
a)The coefficient of variation (CV) of pulse period >25%.
b)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.
7. Please do not use any cuff other than that supplied by the manufacturer as this may result in
inaccurate measurements.
8. For information regarding potential electromagnetic or other interference between the Wireless
Blood Pressure Monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested
that the Wireless Blood Pressure Monitor should be operated at least 10 meters away from electric
or wireless devices (e.g. routers, microwave oven, etc.)
9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on the 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
INTRODUCTION
Thank you for selecting the iHealth Ease Smart Blood Pressure Monitor. The iHealth Ease Smart
Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
mobile device to measure, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Smart Blood Pressure Monitor
• 1 Blood Pressure Cuff
• 1 User Guide
• 1 Charging Cable
INTENDED USE
The iHealth Smart Blood Pressure Monitor (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 standard cuff circumference is 22cm-36cm (8-21/32” to 14-3/16”).
Note: Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this wireless blood pressure
monitor.
PARTS AND DISPLAY INDICATORS
SPECIFICATIONS
1. Product name: Wireless Blood Pressure Monitor
2. Model: BP3L
3. Classification: Internally powered; Type BF applied part; IP20, No AP or APG;
Continuous operation
4. Machine size: approx. 115mm×115mm×66.5mm (4.53”×4.53”×2.62”)
5. Cuff circumference: 22cm - 36cm (8-21/32” to 14-3/16”)
6. Weight: approx. 240g (8.47oz) (exclusive cuff);
7. Power: DC: 5.0V 1A, Battery: 1×3.7V Li-ion 2200mAh
8. Measurement range: Cuff pressure: 0 - 300 mmHg Systolic: 60 - 260 mmHg
Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute
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.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC
60601-1/UL 60601-1 and IEC 60601-1-2.Please do not use any AC adapter other than that
designated by the manufacturer. Please note that the monitor jack size is USB Micro B. The USB
jack should be used for charging only.
This 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.
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.
1. The patient is an intended operator.
2. Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
3. If you are allergic to plastic/rubber, please don’t use this device.
BATTERY HANDLING AND USAGE
• When the monitor is connected to a mobile device, the battery percentage will be displayed in the
mobile device app. If the battery charge is less than 25%, please charge the battery. 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.
• When in charging mode, the LED on the device will be displayed with different colors indicating the
charging status. See the table below for details.
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 when charging.
The monitor, cable, battery and cuff must be disposed of according to local regulations at the
end of their usage.
Note: Battery life and charge cycles vary by use and settings.
Mobile device compatibility
Works with both iOS and Android devices: such as iPhone 7/iPhone 7 Plus/Samsung Galaxy S6
Edge/SM-G9250/Samsung Galaxy Note3 Lite/Motorola Nexus 6
For a complete list of compatible devices, visit our support on page on www.ihealthlabs.eu
Taking a reading on the right arm
Apply the cuff so that the air tube is at the side of your elbow.
Notes:
• Be careful not to rest your arm on the air tube, or otherwise restrict
the flow of air to the cuff.
• The cuff should be 1 to 2 cm above the elbow.
TROUBLESHOOTING
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to return to room temperature before use.
2. If the monitor has not used for a long time, please be sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair. Please
contact the iHealth Customer Service Center to do so.
4. 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 by the iHealth technical department.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. 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.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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.
1. Not servicing/maintenance while the monitor is in use.
2. The monitor requires 6 hours to warm from the minimum storage temperature between uses
until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
3. The monitor requires 6 hours to cool from the maximum storage temperature between uses until
the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C
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 avoid 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
iHealth Labs, Inc. ("iHealth") warrants the iHealth hardware (the "Product"), and only the Product,
against defects in materials and workmanship under normal use for a period of one year (US) or
two years (EU) from the date of purchase by the original purchaser ("Warranty Period"). Under
this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty
Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1)
repair the Product using new or refurbished replacement parts or (2) exchange the Product with a
new or refurbished Product. In the event of a defect, to the extent permitted by law, these are the
sole and exclusive remedies.
This warranty does not apply: (a) to consumable parts, such as the cuff or the battery that diminish
over time, unless failure has occurred due to a defect in materials or workmanship; (b) to cosmetic
damage, including but not limited to scratches, dents ; (c) to damage caused by accident, abuse,
misuse, contact with liquid; (d) to damage caused by operating the iHealth product outside the user
manual, the technical specifications or other iHealth product published guidelines; (e) to damage
caused by service performed by anyone who is not a representative of iHealth or one of its
representatives.
EXPLANATION OF SYMBOLS
Symbol for "Type BF applied parts" (cuff only)
Symbol for "Consult instruction for use
“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 "Keep dry" Symbol for "Warning" Symbol for "Manufacturer"
Symbol for "Serial number" Symbol for “Date of manufacture”
Symbol for "European representative"
Symbol for "Complies with MDD93/42/EEC requirements"
Symbol for “Storage temperature limit” Symbol for “Recycling Symbol”
iHealth is a trademark of iHealth Labs, Inc.
"Made for iPod", "Made for iPhone", and "Made for iPad" mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation of
this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Labs, Inc. is under license.
Other trademarks and trade names are those of their respective owners.
CONTACT AND CUSTOMER SERVICE
Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel:[phone] www.ihealthlabs.com
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.
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.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
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).
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: < 20dBm
Phenomenon
Compliance
Electromagnetic environment
RF emissions
Harmonic distortion
Voltage fluctuations and flicker
CISPR 11 Group 1, Class B
IEC 61000-3-2 Class A
IEC 61000-3-3 Compliance
Home healthcare environment
Home healthcare environment
Home healthcare environment
Table 2 - Enclosure Port
Phenomenon
Electrostatic Discharge
Radiated RF EM field
Proximity fields from RF wireless
communications equipment
Rated power frequency magnetic fields
IEC 61000-4-2
IEC 61000-4-3
Basic EMC
standard Immunity test levels
Home Healthcare Environment
± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz
Refer to table 3
30 A/m 50 Hz or 60 Hz
IEC 61000-4-3
IEC 61000-4-8
Table 1-Emission
7

Table3 – Proximity fields from RF wireless communications equipment
Table 4 – Input a.c. power Port
Test frequency (MHz) Band(MHz) Immunity test levels
Professional healthcare facility environment
385
450
710
745
780
380-390
430-470
Pulse modulation 18 Hz, 27 V/m
FM, ± 5 kHz deviation, 1 kHz sine, 28 V/m
704-787 Pulse modulation 217 Hz, 9 V/m
810
870
930
1720
1845
1970
2450
5240
5500
5785
800-960 Pulse modulation 18 Hz, 28 V/m
Pulse modulation 217 Hz, 28 V/m1700-1990
2400-2570 Pulse modulation 217 Hz, 28 V/m
5100-5800 Pulse modulation 217 Hz, 9 V/m
Phenomenon Basic EMC
standard
Immunity test levels
Home Healthcare Environment
Electrical fast
transients/burst IEC 61000-4-4 ± 2 kV 100 kHz repetition frequency
IEC 61000-4-5
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-11
IEC 61000-4-11
Surges Line-to-line ± 0.5 kV, ± 1 kV
Surges Line-to-ground ± 0.5 kV, ± 1 kV, ± 2 kV
Conducted disturbances
induced by RF fields 3 V, 0.15 MHz to 80 MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz
Voltage dips
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 0% UT; 250/300 cycles
8