iHealth Sense BP7 Wireless Blood Pressure Wrist Monitor User Manual

iHealth Sense BP7 Wireless Blood Pressure Wrist Monitor

MODEL: BP7
OWNER’S MANUAL

INTRODUCTION

Thank you for selecting the iHealth Wireless Blood Pressure Wrist Monitor. The iHealth Wireless Blood Pressure Wrist Monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your mobile devices to test, track and share vital blood pressure data.

PACKAGE CONTENTS

• 1 Wireless Blood Pressure Wrist Monitor
• 1 Owner´s Manual
• 1 Quick Start Guide
• 1ChargingCable
• 1TravelCase

INTENDED USE

The iHealth Wireless Blood Pressure Wrist 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 wrist. The measurement range of the cuff circumference is 5.3″ to 8.7″(13 .5cm-22cm).

BLOOD PRESSURE CLASSIFICATION FOR ADULTS

The World Health Organization (WHO) has created the following guide for assessing high blood pressure (without regard to age or gender). Please note that other factors (e.g. diabetes, obesity, smoking, etc.) also need to be considered. Consult with your physician for accurate assessment.

Classifications of Blood Pressure for Adult

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

It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure Wrist Monitor.

PARTS AND DISPLAY INDICATORS

SET UP REQUIREMENTS

The iHealth Wireless Blood Pressure Wrist 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 V4.3 or higher.

SET UP PROCEDURES

Download the Free iHealth 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.

Charge Battery Prior First Time Use

Connect the monitor to a USB port using the charging cable provided until the green indicator light stabilizes.

Connect to iOS Device via Bluetooth

a. Apply the cuff or press the START/STOP button, the Bluetooth indicator will begin flashing.
b. Turn Bluetooth “On” under the “Settings” Menu on the iOS device.
c. Wait until the model name printed on the monitor, (i.e.”BP7 xxxxxx”) and “Not Paired”appear in the Bluetooth menu, and select the model name “BP7 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.
d. Each subsequent time you use the monitor, “Not Connected” will be displayed next to”BP7 xxxxxx” in the Bluetooth Menu.
e. Please repeat these steps when you switch to another iOS device with the monitor.

MEASUREMENT PROCEDURES

Blood pressure can be affected by the position of the cuff and your physiologic condition. It is very important that you keep your wrist at heart level.

1. Be seated comfortably with your feet flat on the floor without crossing your legs. Stay still during measurement. Do not move your wrist, body, or the monitor.

2. Place your hand palm-side up in front of you and wrap the cuff around a bare wrist 1-2cm above the wrist joint. If the monitor is correctly placed, iHealth logo will be facing upright.

3. The middle of the cuff should be at the level of the right atrium of your heart.
4. It is advised to place the monitor’s travel case under your arm for support and to keep your arm at optimal height for measurement.

5. Adjust the height of your wrist, the App will detect your wrist position and the measurement will start ONLY when the correct position is detected. Follow the on-screen instructions to begin measurement.

Remember to:

1. Make sure that the appropriate cuff size is used; refer to the cuff
circumference range in “ SPECIFICATIONS ”.
2. Measure on the same wrist each time.
3. 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.
4. 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.

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 reestablish the connection with your iOS device automatically. Auto connect option can be enabled in the App. (Device Setting->Auto Connect->On).

Taking Measurements with Multiple iOS Devices
Turn off the Bluetooth on 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 instructions, 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.

SPECIFICATIONS

1. Product name: Wireless Blood Pressure Wrist Monitor
2. Model: BP7
3. Classification: Internally powered;Type BF applied part;IPX0, No AP or APG;Continuous operation
4. Machine size: approx.2.8″×2.9″×0.7″(72mm×74mm×17.6mm)
5. Cuff circumference: 5.3″- 8.7″(13.5cm-22cm), one size only
6. Weight: approx. 3.7oz(106g)(including 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℃～40℃(41℉～104℉)
14. Environmental humidity for operation: ≤90%RH
15. Environmental temperature for storage and transport:-20℃～55℃(-4℉～131℉)
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.
Note : These specifications are subject to change without notice.

GENERAL SAFETY AND PRECAUTIONS

1. Read all of the information in the Owner’s Manual and other provided instructions before operating the unit.
2. 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 wrist 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. When a call comes in during the measurement, the measurement process will be terminated automatically. It is recommended that the iOS device be set in Airplane mode during measurement 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 Wrist Monitor can keep functioning, but the results may be inaccurate. Please consult your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will
be displayed:

1. The coefficient of variation (CV) of pulse period >25%.
2. The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than 53 percent of the total number of pulses.
   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 interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor be kept 10 meters away from other wireless devices, such as WLAN unit, microwave oven, etc.
   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.

This Wireless Blood Pressure Wrist 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.

BATTERY HANDLING AND USAGE

• When the monitor is connected to an 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%. Overcharging the battery may reduce its lifetime.

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.
Note : Battery life and charge cycles vary by use and settings.

TROUBLESHOOTING

CARE AND MAINTENANCE

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 service center.
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 otherwise will void your warranty and possibly damage your unit.
• Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise will possibly damage your Unit.

WARRANTY INFORMATION

The iHealth Wireless Blood Pressure Wrist 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 Wrist Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty.

EXPLANATION OF SYMBOLS

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.

Manufactured for iHealth Lab Inc.
719 N. Shoreline Blvd., Mountain View, CA 94043, USA
+1-855-816-7705 www.ihealthlabs.com

Lotus Global Co., Ltd.
15 Alexandra Road, London UK, NW8 0DP
Tel: +0044-20-75868010 Fax: +0044-20-79006187

ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China
Tel: 86-22-60526161

IMPORTANT INFORMATION REQUIRED BY THE FCC

This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and
(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 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.

OTHER STANDARDS AND COMPLIANCES

The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:

IEC 60601-1:2006 (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: Supplementary requirements for electro-mechanical blood pressure measuring systems);
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 performance of automated non- invasive sphygmomanometers).

ELECTROMAGNETIC COMPATIBILITY INFORMATION

Device Compatibility

Apple iOS devices (requires iOS version 8.0 or higher)

• iPhone 7/7 Plus
• iPhone 6S/6S Plus
• iPhone 6/6 Plus
• iPhone 5S/5C
• iPhone 5
• iPhone 4S
• iPad Air 2
• iPad Air
• iPad Mini 3
• iPad Mini 2
• iPad Mini
• iPad Pro
• iPad 4th Gen
• iPad 3rd Gen
• IPod Touch 6th Gen
• IPod Touch 5th Gen

Android devices (requires operating system 4.0 or later)

• Samsung Galaxy S7/S7 Edge
• Samsung Galaxy S6/S6 Edge
• Samsung Galaxy S5
• Samsung Galaxy S4
• Samsung Galaxy S3
• Samsung Galaxy Note3
• Samsung Galaxy Note2
• HTC One M7
• LG Nexus 4
• LG Nexus 5
• Motorola Nexus 6

FAQs

Troubleshooting:

__Why does the Bluetooth connection not work?

Check the connection between the mobile device and the Wireless Blood Pressure Wrist Monitor. You may need to exit the app, re-connect the Blood Pressure Monitor and start the App again.

If you receive a connection error message or have trouble connecting to your Blood Pressure Monitor with your compatible device, follow the steps below:

• For iOS device:
  1. Go to your Bluetooth settings and unpair BP7XXXXXX from your Bluetooth list.
  2. Turn off Bluetooth and reboot your iOS device by pressing the power button until you are prompted to slide to power off.
  3. After the reboot cycle has completed go ahead and power on your iOS device and enable Bluetooth. Proceed to pair the Blood Pressure Monitor again in the Bluetooth settings and launch the iHealth My Vitals App to start measurement.
• For Android device:
  1. Go to your Bluetooth settings and unpair the BP7XXXXXX from your Bluetooth list.
  2. Turn Bluetooth off and reboot your Android device. After the reboot cycle has completed proceed to enable Bluetooth.
  3. After the reboot cycle has completed go ahead and power on your Android device and enable Bluetooth. Proceed to pair the Blood Pressure Monitor again in the Bluetooth settings and launch the iHealth My Vitals App to start measurement.

__Why does the Wireless Blood Pressure Wrist Monitor not start the

measurement when I manually press the “START/STOP” button?

The battery level might be too low, or the offline measurement function is disabled.

To enable an offline measurement, the monitor must be connected to your device via Bluetooth first. Launch the app and select the gear icon in the bottom right corner, followed by device setting, BP7XXXX and toggle “Offline Measurement” ON. *Please not the Offline Measurement feature can be only be turned on for one compatible iOS/Android device at a time.

__Why does the iHealth Wireless Blood Pressure Wrist Monitor not power

on when I apply the cuff?

Make sure the cuff is applied to your bare wrist, and press “START/STOP” to manually turn on the device.

Setup and Usage:

__Can the Wireless Blood Pressure Wrist Monitor be used with more than

one mobile device?

Yes, you can use the Blood Pressure Wrist Monitor with as many different mobile devices you want. Just install the iHealth MyVitals app on each device you intend to use with the monitor. Make sure to unpair the monitor from the first mobile device’s Bluetooth settings before attempting to use with a second mobile device.

__Can measurements be taken without a mobile device?

Yes. You can enable the offline measurement in the “Set Up My Devices” page of the iHealth MyVitals app. To start measurements when disconnected from the your mobile device (“offline measurement”), turn on the Monitor by pressing the “START/STOP” button. Offline measurement data will be uploaded to the device upon the next successful Bluetooth connection.

__How does the auto connect option work?

The Auto Connect option allows iHealth Wireless Blood Pressure Monitor to look for the last used mobile device and re-establish the connection with that device automatically. The Auto Connect option can be enabled through the iHealth MyVitals app under “Set Up My Devices”, and selecting the correct Blood Pressure Monitor.

Product Information:

__Are there any risks in taking a blood pressure measurement with this

device at home?

There are no physical risks associated with using this device to take your blood pressure at home. If you find the measurement procedure uncomfortable, consult with your healthcare professional regarding proper cuff application and tightness. This monitor is not suitable for use by people with serious arrhythmia due to the possibility of inaccurate measurements.

__What is the cuff size?

The cuff circumference of the iHealth Wireless Blood Pressure Wrist Monitor is 5.3” – 8.6”(13.5 cm – 22 cm)

__What is motion sensor technology?

Wrist blood monitors are sensitive to the wrist position. The iHealth Wireless Blood Pressure Wrist Monitor features a motion sensor technology and arrows to detect the optimal wrist position to help users take their blood pressure reading correctly. The key is to remember to always keep the monitor parallel and aligned with your heart level.

__What are the benefits of monitoring blood pressure at home?

Home monitoring is a great way to help detect and monitor high blood pressure. Regular readings taken over a period of time can track the history of your results and indicate any changes, fluctuations or elevations in your blood pressure. An individual high reading is not necessarily an indication of hypertension or other health issue. The iHealth Wireless Blood Pressure Monitor provides a convenient way to test, track and share your results.

__How accurate is the iHealth Wireless Blood Pressure Monitor?

The iHealth Wireless Blood Pressure Monitor has obtained CE medical certification (Europe) as well as FDA approval (USA). The monitor also has obtained ESH Certification (European Society of Hypertension).

__Who can use the iHealth Wireless Blood Pressure Wrist Monitor?

The iHealth Blood Pressure Monitor is designed for adults. It should not be used on infants, young children, pregnant or pre-eclamptic patients, in addition to people with serious arrhythmia.

__How is the cuff cleaned?

The cuff can be cleaned with a soft cloth lightly moistened with Ethyl alcohol (75-90%) and air dried.

__What is the lifespan of the Wireless Blood Pressure Wrist Monitor?

The monitor lasts a minimum of 10,000 measurements, or 3 years of usage.

__What is the battery life of the Wireless Blood Pressure Wrist

Monitor?

The rechargeable battery is built in and the monitor can take up to 80 measurements on a full charge.

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