iHealth BP3L - Smart Blood Pressure Monitor Manual

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: 5.0V1A, 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
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.

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

PROBLEM	POSSIBLE CAUSE	SOLUTION
Low Battery	Battery is less than 25%	Charge the battery
Display reads "ERROR"	Blood pressure is outside of measurement range	Re-test and contact your health professional if blood pressure measurement is still outside of normal range
	Arm or monitor was moved during test	Re-test, make sure not to move your arm or the monitor
	The cuff does not in ate properly or pressure falls quickly during test	Review the cu application instructions and re-test
	The cuff was not properly applied	Review the cu application instructions and re-test
Display reads an abnormal result	The cuff 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 unstable	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
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.

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.

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:
   1. The application of the cuff over a wound or inflamed area.
   2. The application of the cuff on any limb with intravascular access or therapy, or an arteriovenous (A-V) shunt.
   3. The application of the cuff on the arm on the side of a mastectomy.
   4. Simultaneous use with other medical monitoring equipment on the same limb.
   5. 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:
   1. The coefficient of variation (CV) of pulse period >25%.
   2. The difference of adjacent pulse period is ≥0.14s and more than 53 percent of the total number of pulses readings falls within this definition.
7. 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.)
8. 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
9. Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate measurements 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.

CONTACT AND CUSTOMER SERVICE

Manufactured for iHealth Labs, Inc.
120 San Lucar Ct., Sunnyvale, CA 94086
Tel: +1-855-816-7705 www.ihealthlabs.com;

iHealthlabs Europe SAS
36 Rue de Ponthieu, 75008, Paris, France support@ihealthlabs.eu www.ihealthlabs.eu

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