iHealth BP5 User manual

Wireless Blood Pressure Monitor (BP5)
OWNER’S MANUAL
EN
Table of Contents
INTRODUCTION
PACKAGE CONTENTS
INTENDED USE
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
CONTRAINDICATION
PARTS AND DISPLAY INDICATORS
SET UP REQUIREMENTS
SET UP PROCEDURES
MEASUREMENT PROCEDURES
SPECIFICATIONS
GENERAL SAFETY AND PRECAUTIONS
BATTERY HANDLING AND USAGE
TROUBLESHOOTING
CARE AND MAINTENANCE
WARRANTY INFORMATION
EXPLANATION OF SYMBOLS
IMPORTANT INFORMATION REQUIRED BY THE FCC
OTHER STANDARDS AND COMPLIANCES
ELECTROMAGNETIC COMPATIBILITY INFORMATION
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INTRODUCTION
Thank you for selecting the iHealth Wireless Blood Pressure Monitor. The iHealth Wireless Blood
Pressure Monitor is a fully automatic arm cuff blood pressure monitor that uses the oscillometric
principle to measure your blood pressure and pulse rate. The monitor works with your mobile
device to test, track and share vital blood pressure data.
• 1 iHealth Wireless Blood Pressure Monitor
• 1 Owner’s Manual
• 1 Quick Start Guide
• 1 Charging Cable
• 1 Travel Bag
PACKAGE CONTENTS
INTENDED USE
The iHealth Wireless 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 cuff circumference is 8.6” to18.9”(22cm-48cm).
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It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure
Monitor.
Note: This chart is not intended to provide a basis for any type of emergency condition or
diagnosis based on the color scheme; this chart only depicts different classifications of blood
pressure. Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
PARTS AND DISPLAY INDICATORS
The World Health Organization (WHO) has created the following guide for assessing high blood
pressure (without regard to age or gender). Please note that other factors (e.g. diabetes, obesity,
smoking, etc.) also need to be considered. Consult with your physician for accurate assessment.
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
160
180
Systolic
(mmHg)
Diastolic
(mmHg)
140
130
120
80 85 90 100 110
Severe Hypertension
Moderate Hypertension
Mild Hypertension
High-normal BP
Normal BP
Classification of blood pressure for adults
BLOOD PRESSURE
CLASSIFICATION
SBP
mmHg
DBP
mmHg
COLOR
INDICATOR
Optimal <120 <80 GREEN
Normal 120-129 80-84 GREEN
High-normal 130-139 85-89
Grade 1 Hypertension 140-159 90-99
GREEN
Grade 2 Hypertension 160-179 100-109
YELLOW
Grade 3 Hypertension RED
ORANGE
≥180 ≥100
WHO/ISH Denitions and Classication of Blood Pressure Levels
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The iHealth Wireless Blood Pressure Monitor is designed to be used with the following iPod touch,
iPhone and iPad models:
iPod touch (5th generation)
iPod touch (4th generation)
iPod touch (3rd generation)
iPhone 5
iPhone 4S
iPhone 4
iPhone 3GS
iPad (4th generation)
iPad (3rd generation)
iPad 2
iPad
iPad mini
The iOS version of these devices should be V5.0 or higher.
SET UP REQUIREMENTS
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Bluetooth indicator Status indicator
START/STOP button
Cuff
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SET UP PROCEDURES
Download the Free iHealth MyVitals App
Prior to first use, download and install "iHealth MyVitals" from the App Store.
Account Set Up and Registration
Follow the on-screen instructions to register and set up your personal account.
Connect to iOS Device via Bluetooth
• Apply the cuff or press the START/STOP button, the
Bluetooth indicator will begin flashing.
• Turn Bluetooth "On" under the "Settings" menu on
the iOS device.
• Wait until the model name printed on the monitor,
(i.e."BP5 xxxxxx") and "Not Paired" appear in
the Bluetooth menu, and select the model name
"BP5 xxxxxx" to pair and connect. The Bluetooth
indicator will remain steady upon successful
connection. When using the monitor for the first
time, it may take up to 30 seconds for your iOS
device to detect the Bluetooth signal.
Charge Battery Before First Use
Connect the monitor to a USB port using the charging cable provided until the green indicator
light stabilizes.
• Each subsequent time you use the monitor, "Not Connected" will be displayed next to "BP5
xxxxxx" in the Bluetooth Menu.
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MEASUREMENT PROCEDURES
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Body Posture
Sitting Comfortably During Measurement
a. Be seated with your feet flat on the floor without crossing your legs.
b. Place your hand palm-side up in front of you on a flat surface such as a desk or a table.
c. The middle of the cuff should be at the level of the right atrium of your heart.
Lying Down During Measurement
a. Lie on your back.
b. Place your arm straight along your side with your hand palm-side up.
c. The cuff should be placed at the same level as your heart.
Note: Blood pressure can be affected by the position of the cuff and your physiologic condition.
Blood pressure can be affected by the position of the cuff and your physiologic condition. It is very
important that the cuff should be placed at the same level as your heart.
Waiting to connect Flashing blue light
Connected and measuring Steady blue light
Measurement completed and ready to disconnect Gradually extinguishing light
Monitor Status Bluetooth Indicator
• Please repeat these steps when you switch to another iOS device with the monitor.
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Apply the Cuff
a. Pull the cuff end through the metal loop, positioning it outward
(away from your body).
b. Place a bare arm through the cuff and position the cuff
1/2” (1-2cm)above the elbow joint.
c. Tighten the cuff by pulling it towards your body, securing it
closed with the Velcro fastener.
d. While seated, place your hand, palm-side up, in front of you on a flat surface such as a desk or
table. Position the monitor in the middle of your arm so that it is aligned with your middle finger.
Remember to:
1. Make sure that the appropriate cuff size is used; refer to the cuff circumference range in the
Specifications section of this manual.
2. Measure on the same arm each time.
3. Stay still during measurement. Do not move your arm, body or the monitor.
4. Stay still and calm for one to one and half minutes before taking a blood pressure measurement.
Prolonged over-inflation of the bladder may cause ecchymoma of your arm.
e. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one
finger between your arm and the cuff.
up
Down
1/2” (1-2cm)
ON/OFF
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5. Keep the cuff clean. Cleaning the cuff after every 200 times of usage is recommended.If the cuff
becomes dirty, clean it with a moistened cloth. Do not rinse the monitor or cuff with running
water.
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During measurement, press the "START/STOP" button to stop measurement. Press the
"START/STOP" button for 2 seconds to turn off the monitor manually.
Auto Connect Option
Auto connect option allows the monitor to find the last used iOS device and re-establish the
connection automatically. Auto connect option can be enabled in the App. (Device Setting -> Auto
Connect -> On)
Taking Measurements with Mutiple iOS Devices
Turn off the Bluetooth of the last used iOS device if the Auto Connect option is enabled in your
App, then follow the Set Up Instructions in the Quick Start Guide.
Measuring without an iOS Device
Enable the Offline Measurement function on the App.(Device Setting -> Offline Measurement ->
On)Apply the cuff, follow the "Measurement Procedures", and then press the "START/STOP"
button to begin measurement. All offline measurements will be uploaded to the App automatically
upon the next successful Bluetooth connection.
For detailed operating instructions, please visit www.ihealthlabs.com.
Note: Physical activity including eating, drinking, and smoking as well as excitement, stress, and
many other factors influence blood pressure results.
ATTENTION: You can stop the measurement process at any time by pressing and holding the
"START/STOP" button for 2 seconds.
Remember to:
1. Make sure that the appropriate cuff size is used; refer to the cuff circumference range in the
Specifications section of this manual.
2. Measure on the same arm each time.
3. Stay still during measurement. Do not move your arm, body or the monitor.
4. Stay still and calm for one to one and half minutes before taking a blood pressure measurement.
Prolonged over-inflation of the bladder may cause ecchymoma of your arm.
5. Keep the cuff clean. Cleaning the cuff after every 200 times of usage is recommended.If the cuff
becomes dirty, clean it with a moistened cloth. Do not rinse the monitor or cuff with running
water.
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1. Product name: Wireless Blood Pressure Monitor
2. Model: BP5
3. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous
operation
4. Machine size: approx. 5.7” x 2.3” x 1.2”(145mm × 58mm × 30mm)
5. Cuff circumference: 8.6”-16.5”(22cm-42cm), 16.5”-18.9”(42cm-48cm) (XL size sold
separately)
6. Weight: approx. 5.1oz (145g) (including cuff); approx.5.6oz(160g) (including XL cuff)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 120 times with time and date stamp (off-line measurement only)
9. Power: DC: 5.0V 1.0A, Battery: 1*3.7V Li-ion 400mAh
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
11. Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
12. Wireless communication:
Bluetooth V3.0 + EDR Class 2 SPP
Frequency Band: 2.402-2.480 GHz
13. Environmental temperature for operation: 5°C~40°C(41°F~104°F)
SPECIFICATIONS
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Note: These specifications are subject to change without notice.
1. Read all of the information in the Owner’s Manual 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 arterio-
venous (A-V) shunt.
c) The application of the cuff on the arm on the side of a mastectomy.
d) Simultaneous use with other medical monitoring equipment on the same limb.
e) The blood circulation of the user needs to be checked.
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 Sphygmoma-
nometer.
5. when a call comes in during the measurement, the measurement process will be terminated
GENERAL SAFETY AND PRECAUTIONS
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automatically. It is recommended that the iOS device be set in Airplane mode during measure-
ment to avoid strong magnetism interference.
6. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Wireless Blood Pressure Monitor can keep functioning,
but the results may be inaccurate. Please consult your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be displayed:
a) The coefficient of variation (CV) of pulse period >25%.
b) The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than
53 percent of the total number of pulses.
7. Please do not use any other cuff other than that supplied by the manufacturer as this may result
in measurement errors and a biocompatible hazard.
8. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such interfer-
ence, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the
blood pressure monitor be kept 10 meters away from other wireless devices, such as WLAN
unit, microwave oven, etc.
9. This product should not be used as a USB device.
14. Environmental humidity for operation: ≤90%RH
15. Environmental temperature for storage and transport: -20°C~55°C(-4°F~131°F)
16. Environmental humidity for storage and transport: ≤90%RH
17. Environmental pressure: 80kPa-105kPa
18. Battery life: more than 80 measurements on a full charge
19. The blood pressure measurement system includes accessories: pump, valve, cuff, and sensor.
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automatically. It is recommended that the iOS device be set in Airplane mode during measure-
ment to avoid strong magnetism interference.
6. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will
be displayed. Under this condition, the Wireless Blood Pressure Monitor can keep functioning,
but the results may be inaccurate. Please consult your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be displayed:
a) The coefficient of variation (CV) of pulse period >25%.
b) The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than
53 percent of the total number of pulses.
7. Please do not use any other cuff other than that supplied by the manufacturer as this may result
in measurement errors and a biocompatible hazard.
8. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such interfer-
ence, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the
blood pressure monitor be kept 10 meters away from other wireless devices, such as WLAN
unit, microwave oven, etc.
9. This product should not be used as a USB device.
10. This product is verified by auscultatory method. It is recommended that you check Annex B of
ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed.
11. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this
case, consult a physician or ensure that proper measurement procedures are followed. The
technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical
alarm is assigned as low priority according to IEC 60601-1-8.The technical alarm is
non-latching and does not need to be reset.
12. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1
and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor, such as ASP5-05010002JU
(input: 100-240V, 50/60Hz, 200mA; output: DC 5.0V, 1.0A). Please note that the monitor jack
size is USB mini B.
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• When the monitor is connected to the iOS device, the battery volume will be displayed on the
iOS device. If the power is less than 25%, please charge the battery. The monitor will not work
until the battery has enough power.
• When you charge the monitor, the LED will display with different colors indicating the charging
status. See the table below for details.
• When charging is needed, please connect the monitor to a power source. The monitor can work
normally while charging.
• It is suggested that you charge the battery when the battery is less than 25%.
BATTERY HANDLING AND USAGE
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10. This product is verified by auscultatory method. It is recommended that you check Annex B of
ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed.
11. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this
case, consult a physician or ensure that proper measurement procedures are followed. The
technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical
alarm is assigned as low priority according to IEC 60601-1-8.The technical alarm is
non-latching and does not need to be reset.
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This Wireless Blood Pressure Monitor is designed for adults and should never be used on
infants, young children, pregnant or pre-eclamptic patients. Consult your physician before use
on children.
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.
12. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1
and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor, such as ASP5-05010002JU
(input: 100-240V, 50/60Hz, 200mA; output: DC 5.0V, 1.0A). Please note that the monitor jack
size is USB mini B.
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Note: Battery life and charge cycles vary by use and settings.
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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 pull out the adapter when you are using the monitor.
Do not use any other type of AC adapter as it may harm the monitor.
The monitor, cable, battery and cuff must be disposed of according to local regulations at
the end of their usage.
Monitor Status Status Indicator
Charging Flashing green light
Fully charged Steady green light
Low battery Flashing red light (for a few seconds)
Abnormal state Steady red light
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TROUBLESHOOTING
PROBLEM POSSIBLE CAUSE SOLUTION
Battery is less than 25% Charge the batteryLow Battery
Blood pressure is outside of measurement range Retest, make sure your blood pressure is within
measurement range
Arm or monitor was moved during test Retest, make sure not to move your arm or the monitor
The cuff does not inflate properly or pressure
falls quickly during test
Review the cuff application instructions and retest
Irregular heartbeat (arrhythmia) It is inappropriate for people with serious arrhythmia to
use this monitor. Check with physician
The cuff was not properly applied Review the cuff application instructions and retest
Display reads
"ERROR"
The cuff position was not correct or it was not
properly tightened
Review the cuff application instructions and retest
Incorrect operation or strong electromagnetic
interference
Press the START/STOP button about 10 seconds to reset
the device, relaunch app, and reconnect the iOS device
to the monitor
No response
Body posture was not correct during testing Review body posture instructions and retest
Speaking, moving arm or body, being angry,
excited or nervous during test
Retest when calm; avoid speaking or movement
during the test
Bluetooth connection unsuccessful, monitor is
abnormal, or strong electromagnetic
interference is present
Reset iOS device. Reset monitor by pressing the
START/STOP button about 10s. Make sure the monitor
and iOS device are away from other electrical
equipment. Please see GENERAL SAFETY AND
PRECAUTIONS
Display reads
an abnormal
result
Bluetooth
connection
unstable
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1. If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature
before use.
2. If the monitor is not used for a long time, please 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 Customer Service.
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.
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 of the closure.
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, for example, in a hospital or a clinic, it be disinfected
twice a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth lightly
moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
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
CARE AND MAINTENANCE
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The iHealth Wireless Blood Pressure Monitor is warranted to be free from defects in materials
and workmanship within one year from the date of purchase when used in accordance with the
provided instructions. The warranty extends only to the end user. We will, at our option, repair
or replace without charge the iHealth Wireless Blood Pressure Monitor covered by the
warranty. Repair or replacement is our only responsibility and your only remedy under the
warranty.
WARRANTY INFORMATION
EXPLANATION OF SYMBOLS
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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 "THE OPERATION GUIDE MUST BE READ"
The sign background color: blue The sign graphical symbol: white
Symbol for "KEEP DRY"
Symbol for "TYPE BF APPLIED PARTS" (cuff only)
otherwise will void your warranty and possibly damage your unit.
Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise
will possibly damage your unit.
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iHealth is a trademark of iHealth Lab 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 Lab Inc. is under license. Other trademarks and trade
names are those of their respective owners.
Symbol for "WARNING"
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Symbol for "EUROPEAN REPRESENTATIVE"
EC REP
Symbol for "COMPILES WITH MDD93
/42/EEC REQUIREMENTS"
Symbol for " MANUFACTURER "
Symbol for "SERIAL NUMBER"
SN
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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 Lab Inc. would void the user’s authority
to operate the product.
Note: This product has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This product generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this product does cause harmful interference
Lotus Global Co., Ltd.
15 Alexandra Road, London UK, NW8 0DP
Tel: [phone] Fax: [phone]
EC REP
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.
Tel: [phone]
Manufactured for iHealth Lab Inc.
719 N. Shoreline Blvd., Mountain View, CA 94043, USA
[phone] www.ihealthlabs.com
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OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005 (Medical electrical equipment – Part 1: General requirements for safety);
IEC 60601-1-2:2007 (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: Supplemen-
tary requirements for electro-mechanical blood pressure measuring systems);
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.
This product is approved in accordance to R&TTE directive transmitter.
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ELECTROMAGNETIC COMPATIBILITY INFORMATION
For all ME EQUIPMENT and ME SYSTEMS
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
The Wireless Blood Pressure Monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
The MONITOR is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
Guidance and manufacture’s declaration - electromagnetic emissions
Table 1
ANSI/AAMI SP-10:2002+A1: 2003+A2:2006;
AAMI/ANSI 80601-2-30: 2009/IEC 80601-2-30: 2009+Cor.2010/EN 80601-2-30:2010(Medical
electrical equipment –Part 2-30: Particular requirements for the basic safety and essential perfor-
mance of automated non-invasive sphygmomanometers).
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