Gima iHEALTH TRACK CONNECTED B.P.M. User guide

EN
Fully Automatic iHealth Track Connected Arm Blood Pressure Monitor USER MANUAL
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Note: This is a shortened practical version of the user manual. For the full version of this user manual, please visit www.ihealthlabs.eu/support
MEASURING BLOOD PRESSURE – A FEW BASICS
1. Relax for 5 minutes before taking your blood pressure.
2. Sit comfortably at a table when measuring your blood pressure.
3. The cu should be placed at the same level as your heart.
4. Do not talk or move during a measurement.
5. Use the same arm every time.
6. Remove the batteries from the device if it is not used for a month or more to avoid battery leakage.
7. This blood pressure monitor is designed for adults and should not be used on children.
8. It is not recommended for people with serious arrhythmia to use this device.
9. Do not use any other cu than the one supplied by iHealth.
10. Relax…
WHAT YOUR DEVICE SHOULD LOOK LIKE
The explanation of symbols on the display: Bluetooth Symbol Synchronization Symbol Release Air Symbol Memory Indicator Low Battery Indicator
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Irregular Heartbeat Symbol Blood Pressure Level Classication Indicator
Memory/Sync button
Start/Stop button
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WHY YOU SHOULD CONNECT YOUR DEVICE
Taking a measurement is easy. Its what you do with the measurement that is important. You can use your device as a stand-alone device just to measure your blood pressure, but when you connect it to the free iHealth MyVitals App you will be able to track, store, manage and share your results with your family, doctor or care givers. Simply download iHealth MyVitals on the Apple Store or on GooglePlay and start managing your health.
Your iHealth account also gives you access to the free and secure iHealth cloud service so that you can manage your data, watch your trends and share your data. To do this, visit www.ihealthlabs.eu and log in
using the same account as you used with your App.
The iHeath Track Blood Pressure Monitor is designed to be used with Bluetooth 4.0 Apple devices and selected Bluetooth 4.0 Android smartphones. Please note that the compatible devices are subject to
change. For the latest compatibility list visit www.ihealthlabs.eu/support.
HOW TO USE YOUR BLOOD PRESSURE MONITOR
1. BATTERIES
a. Open the battery cover at the back of the device. b. Load four AAA size batteries. Please pay attention to polarity. c. Close the battery cover. When the display shows the battery symbol ( ), replace all the batteries with new ones. Rechargeable batteries are not suitable for this monitor.
The monitor, the batteries and the cu must be disposed of according to local regulations at the end of
their usage.
2. HOW TO PLACE THE CUFF ON YOUR ARM
The iHeath Track Blood Pressure Monitor has a universal size cu. This means that it will t any arm with a circumference between 22 and 42cm. If your arm is too large to t in this cu, you might consider using a wrist blood pressure monitor.
a. Place the cu tube downwards, around a bare arm about 2cm above the elbow joint.
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b. Sit with your feet at on the oor without crossing your legs. While seated, place your palm upside in front of you on a at surface such as a table.Lying Down During Measurement:(You can also lie on your back and place your left arm straight along your side with your hand palm-side up. Position the air tube in the middle of your arm in line with your middle nger.
1/2”(1-2 cm)
c. Close the cu with the Velcro fastener. d. The cu should t comfortably around your arm. You should be able to insert one nger between your arm and the cu.
Note: If the cu becomes dirty, remove it from the monitor and wipe it with a lightly moistened soft cloth. Then air-dry the cu. Do not machine wash.Cleaning the cu after every 200 measurements is recommended.
3. CONNECTING THE CUFF TO THE DEVICE
Once you have determined that the cu ts your arm (22 – 42cm), simply insert the cu connector into the socket on the side of the monitor. Ensure that the connector is completely inserted to avoid air leakage.
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Avoid compression or restriction of the connection tubing during measurementwhich may cause ination error, or harmful injury due to continuous cu pressure.
4. SETTING THE DATE AND TIME
Insert the batteries in the device and connect it with the iHealth MyVitals App on your smartphone. The time and date will automatically be updated. If you change the batteries, please readjust the time and date again.
5. TAKING A BLOOD PRESSURE MEASUREMENT
a. After placing the cu on your arm and relaxing for a few minutes, press the “START/STOP button. All display characters are shown for self-test, please contact the service center if segment is missing. b. The monitor will inate the cu and then slowly release pressure from the cu as the blood pressure is measured. When the measurement is nished the blood pressure and pulse rate will be displayed on the display. The blood pressure will be displayed in dierent colours (green for normal, yellow for slightly elevated, and red for high) according to the recommendations of the WHO (World Health Organization), The result will automatically be stored in the memory bank of the monitor. c. If an Irregular Heartbeat (IHB) is detected during a measurement, the IHB symbol will be displayed (blinking). If an IHB is detected, the results of the blood pressure measurement may be inaccurate. Please consult your physician for an accurate assessment. d. At any time you can synchronize your device with the iHealth MyVitals App so that you can better manage your blood pressure. e. The monitor will automatically switch o after one minute to save the batteries. Alternatively, you can press the “START/STOP button to turn o the monitor manually. f. At any time during a measurement, you can interrupt a measurement by pressing the “START/STOP button.
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CLASSIFICATION OF BLOOD PRESSURE AND BACKLIGHT INDICATOR
BLOOD PRESSURE CLASSIFICATION
Optimal
Normal
High-normal
Grade 1 Hypertension
Grade 2 Hypertension
Grade 3 Hypertension
6. MEMORIES
You can review previous readings by pressing the M button twice. The rst memory displayed will be the average of the last three measurements. When the average of the last three measurements display, press the M button, the newest measurement will display. Press M button again to review the next measure- ment. During display the memories, keep on pressing button "M" for three seconds, all results in the current memory bank will be deleted. If no result stored, LCD will show zero.
Systolic mmHg
91–119
120–129
130–139
140–159
160–179
180
Diastolic mmHg
and 61 - 79
and 80 -84
or 85 - 89
or 90 - 99
or 100–109
or 110
BACKLIGHT INDICATOR
Green
Green
Yellow
Flashing Yellow
Red
Flashing red
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The monitor will automatically switch o after one minute to save the batteries. Alternatively, you can press the "START/STOP" button to turn o the monitor manually.
7. SYNCHRONIZING WITH THE IHEALTH MYVITALS APP
Before you can synchronize all your blood pressure readings, you need to download the iHealth MyVitals App on your smartphone from the Apple Store (for iOS devices) or on GooglePlay Store (for Android). You then need to create your own iHealth account on the App. To synchronize:
1. Place your phone next to your blood pressure monitor.
2. Start the iHealth MyVitals App on your smartphone (ensure that your Bluetooth is activated in your settings).
3. Press the M (Memory) button on the blood pressure monitor. The number of readings in the memory will be displayed. After a few seconds the iHeath Track Blood Pressure Monitor will automatically start synching the readings to the iHealth MyVitals App. While it is synchronizing you will see the readings numbers gradually come down on the blood pressure monitor, until they reach zero. When zero is displayed on your monitor, it means that all the readings have been synchronized and that you can new view all your data in the “List of the iHealth MyVitals App.
4. If no result stored, the number of readings in the memory will be displayed zero.
8. TROUBLESHOOTING
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Problem
LCD shows low battery symbol
LCD shows “Er 0”
LCD shows “Er 1”
LCD shows “Er 2”
LCD shows “Er 3”
LCD shows “Er 4”
LCD shows “Er 5”
LCD shows “Er 6”
LCD shows “Er 7”
LCD shows “Er 8”
LCD shows “Er A
No response when you press
button or install batterypiles
Explanation Solution
Low Battery
Pressure system is unstable before
measuremente
Fail to detect systolic pressure
Fail to de tec t di ast oli c pr ess ure
Pneumatic system blocked or cu is too
tight during ination
Pneumati c system le akage or c u is too
loose during ination
Cu pressu re above 300mmHg
More than 3 minutes with cu pressure
above 15 mmHg
EEPROM accessing error
Device parameter checking error
Pressure sensor para meter erroro n
Incorrect operation or strong electromagnetic interference.
Change all the batteries
Try again without moving
Apply the cu correctly
and try again
Measure again after 5 minutes. If the error is still there, please contact your
local iHealth distributor
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Take out the batteries, wait
ve minutes and then
reinstall batteries
Please visit the support section of the www.ihealthlabs.eu website to see our comprehensive Frequently Asked Questions on blood pressure.
9. GENERAL SAFETY AND PRECAUTIONS
1. Carefully read the user guide before operating the device.
2. Consult your physician for any of the following situations: a) The application of the cu over a wound or inamed area. b) The application of the cu on the arm on the side of a mastectomy. c) Simultaneous use with other medical monitoring equipment on the same limb. d) The application of the cu on any limb with intravascular access or therapy, or an arteriovenous (A-V) shunt. 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. The IHB symbol will be displayed under 2 sets of circumstances: a) The coecient of variation (CV) of pulse period >25%. b) The dierence of adjacent pulse period is 0.14s and more than 53% of the total number of pulses readings falls within this denition.
5. Please do not use any cu other than that supplied by the manufacturer as this may result in inaccurate measurements.
6. The monitor will show 'HI' or 'Lo' as technical alarm on LCD with no delay if the determined blood pressure (systolic or diastolic) is outside the rated range specied in part SPECIFICATIONS. In this case, you should consult a physician or check if your operation violated the instructions. The technical alarm condition (outside the rated range) is pre-set in the factory and cannot be adjusted or inactivated. This alarm condition is assigned as low priority according to IEC 60601-1-8. The technical alarm is non-latching and needs no reset. The signal displayed on LCD will disappear automatically after about 8 seconds. This Monitor is designed for adults and should never be used on infants, young children or patients
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with preeclampsia. This product might not meet its performance specications if stored or used outside the specied temperature and humidity ranges. Please do not share the cuff with any infectious person to avoid cross-infection.
The monitor, cable, battery and cu must be disposed of according to local regulations at the end of their usage.
7. Prolonged over-ination of the bladder may cause bruises of your arm.
10. CARE AND MAINTENANCE
1. Do not drop the monitor or subject it to strong impacts.
2. Avoid high temperature and direct exposure to the sun. Do not immerse the monitor in water.
3. If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature before use.
4. Do not attempt to disassemble this monitor.
5. If you do not use the monitor for a long time, please remove the batteries.
6. It is recommended that the performance of this monitor be checked every 2 years.
7. Please clean monitor with a soft dry cloth. Do not use any abrasive or volatile cleaners.
8. The supplier will make available on request the circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the users appropriately qualied technical personnel to repair those parts of equipment which are designated by the manufacturer as repairable.
9. It is recommended that if the cu 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 cu with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then air dry the cu.
10. The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years, and the cu integrity is maintained after 1,000 open -close cycles of the closure.
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11. AFTERSALES AND WARRANTEE
This device has been developed by iHealth together with a team of medical specialists and engineers. We have taken the utmost care to manufacture a device that is user friendly and clinically accurate. It has been validated against the exacting standard of the ESH (European Society of Hypertension) and as such can be used by a medical professional in clinical practice. The iHeath Track Blood Pressure Monitor carries a two-year warrantee according to European legislation.
If you have any questions regarding the aftersales or usage of the product, please visit www.ihealthlabs.eu and consult our Frequently Asked Questions on blood pressure (in our support section). If you do not nd the answers you are looking for, please send us a query directly from the website. If you have any suggestions so that we can improve our products, please send us a mail at support@ihealthlabs.eu.
12. EXPLANATION OF SYMBOLS ON PACKAGING
Symbol for "THE OPERATION GUIDE MUST BE READ" (The sign background color: blue. The sign graphical symbol: white.
Symbol for Warning
Symbol for Type BF Applied Parts (cu only)
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".
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Symbol for "KEEP DRY" Symbol for Manufacturer
Symbol for “DATE OF MANUFACTURE” Symbol for "EUROPEAN REPRESENTATIVE"
Symbol for "SERIAL NUMBER"
CE conformity mark
iHealthLabs Europe 3 rue Tronchet, 75008, Paris, France support@ihealthlabs.eu www.ihealthlabs.eu
ANDON HEALTH CO., LTD Add:No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China. Tel: 86-22-60526161
iHealth is a trademark of iHealth Lab Inc. 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.
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13. SPECIFICATIONS
Product name: iHeath Track Blood Pressure Monitor Model: KN-550BT Classication: Internally powered, type BF applied part; IPX0, No AP or APG; Continuous operation Machine size: 98 × 98 × 46mm Cu circumference: 22 - 42cm Weight: 348g (batteries and cu included) Measuring method: oscillometric method, automatic ination and measurement Memories: 99 Power source: 4x1.5V SIZE AAA batteries Measurement range: Cu pressure: 0 - 300mmHg Systolic: 60 - 260mmHg Diastolic: 40 - 199mmHg Pulse rate: 40 - 180 beats/minute Measuring accuracy: Pressure: ±3mmHg, Pulse rate: ±5% Environmental temperature for operation: 1040°C Environmental humidity for operation: 85% Environmental temperature for storage: -2050°C Environmental humidity for storage: 85% Environmental pressure: 80105kPa Battery life: Approximately 250 readings This blood pressure measurement system includes accessories: pump, valve, cu, and sensor.
Note: These specications are subject to change without notice.
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This device bears the CE conformity mark. The quality of this wireless device has been veried and conforms to the provisions of the IEC 60601-1:2005 corr.1 (2006) + corr.2 (2007)/EN 60601-1:2006/AC:2010 (Medical electrical equipment – Part 1: General requirements for safety); IEC 60601-1-2:2007 /EN 60601-1-2:2007 /AC:2010 (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+Cor.2010 (Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).
R&TTE mention: Hereby, iHealth declares that the BP Track KN-550BT is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Directive 1999/5/EC Declaration of Conformity and all iHealth certication and regulatory documents can be downloaded on the following link: https://www.ihealthlabs.eu/support/certications.
For information regarding potential electromagnetic or other interference between the iHeath Track Blood Pressure Monitor and other devices together with advice regarding avoidance of such interference, please visit www.ihealthlabs.eu/support/electromagnetic. It is suggested that the Wireless Blood Pressure Monitor should be operated at least 10 metres away from electric or wireless devices (e.g. routers, microwave oven, etc.).
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