Fora Diamond CUFF BP, TD-3140 Owner's Manual

Owner’s Manual
Blood Pressure Monitoring System
CUFF BP
TD-3140
3
Thank you for purchasing the FORA Diamond Cuff BP Blood Pressure Monitoring System. This manual provides important information to help you operate this system correctly. Before using this product, please read the following contents thoroughly and carefully.
Managing your blood pressure is simple with this device. Itʼs small enough to take with you anywhere, and auto-uploads all of your readings to the iFORA smartphone App. In addition, this device will help you and your healthcare professional, to keep your blood pressure under control and adjust your treatments plans as needed.
If you have other questions regarding this product, please contact the place of purchase.
Version 3.0 2015/05
311-3140100-008
English
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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use the device if it is not working properly or damaged.
3. Do NOT use under any circumstances on newborns.
4. This device does NOT serve as a cure for any symptoms or diseases. The data measured are for reference only. Always consult your doctor to have the results interpreted.
5. Keep the equipment away from hot surfaces.
6. Do NOT apply the cuff to areas other than the place directed.
7. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges. This may cause erroneous results.
8. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
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TABLE OF CONTENTS
BEFORE YOU BEGIN 06
Intended Use 06 Test Principle 06 Contents of System 06 Meter Overview 07 Display Screen 08
HOW TO INSTALL AND UPDATE THE iFORA BP 09
BLUETOOTH PAIRING 10
IMPORTANT INFORMATION ABOUT PERFORMING A BLOOD PRESSURE TEST 14
Before Measurement 14 Apply the Cuff Properly 14 Proper Measurement Position 16
HOW TO TEST YOUR BLOOD PRESSURE 17
Taking Measurement by the Device Itself 17 Taking Measurement with the iFORA BP App 19
VIEWING PREVIOUS RESULTS 22
Reviewing Data Record 22 Reviewing Day Average Results 24
Blood Pressure Classification 26
MAINTENANCE 27
Battery 27 Caring for Your Meter 28
DETAILED INFORMATION 29
SYSTEM TROUBLESHOOTING 30
Error Messages on Meter 30 Troubleshooting 31
SPECIFICATIONS 32
FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 33
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Test Principle
Blood pressure is measured non-invasively at the arm based on oscillometric method.
This device is NOT able to take measurements in the presence of common arrhythmia, such as atrial or ventricular premature beats or atrial fibrillation. It may produce reading error.
Contents of System
Your new FORA Diamond Cuff BP Blood Pressure Monitoring System includes:
BEFORE YOU BEGIN
Intended Use
FORA Diamond Cuff BP Blood Pressure Monitoring System is a system
designed to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. It is intended for individuals age 18 and up, for use in a home or clinical setting. The device is not to be used for the diagnosis of hypertension or for testing on newborns.
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4 x AAA Batteries Protective Wallet
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2
3
Meter with Cuff Ownerʼs Manual Quick Start User Guide / Warranty Card
1 4 52 3
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Meter Overview
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BT Indicator
Download test results with a Bluetooth connection.
Cuff (immovable)
Display Screen
Battery Compartment
ON/OFF Button
BT Pairing Button
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2
3
5
4
2
1
3
4
6
5
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Display Screen
Units of Blood Pressure
Systolic Pressure Symbol
Diastolic Pressure Symbol
Pulse Rate
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6
7
8
Low Battery Symbol
Pulse Rate Symbol
Diastolic Pressure Value
Systolic Pressure Value
1
2
3
4
4 3 2 1
5 6 7 8
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HOW TO INSTALL AND UPDATE THE iFORA BP
System Requirement
iOS version 6 or above Android version 4.3 or above
Installing
iFORA BP is available on the App Store/Google Play for free download. Connect your mobile device to the internet to download the iFORA BP and then install it on your mobile device.
Updating
When new features are added to the iFORA BP App, the App Store/Google Play will notify you automatically. Please perform the updates accordingly to provide you with the latest features that we have developed in your best interest.
You can use the FORA Diamond Cuff BP Blood Pressure Monitoring System by itself or with the iFORA BP App.
iFORA BP is designed to assist you in easily monitoring, recording, and tracking your blood pressure. The app is simple to use and helps you to better understand your current condition as well as control your hypertension.
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BLUETOOTH PAIRING
You can transmit your data from the meter to your devices (e.g. smart phone, tablet, PC...) via Bluetooth. Please contact your local customer service or place of purchase for assistance. Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data.
Pairing with Your Mobile Device
1. Turn on the Bluetooth function on your
mobile device.
2. Press the Bluetooth button on the meter. PCL will be displayed on the meter screen during the pairing process.
3. On your mobile device, launch the iFORA BP app. Select the Setting tab on the bottom right of the screen.
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5. Tap the Search button to search for available Bluetooth Smart meters. Wait for a few seconds, a pop-up window shows up to display the search results.
6. Select Diamond Cuff to start pairing.
4. Tap the Pair button to activate the
Bluetooth function.
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7. When pairing is complete, Diamond Cuff BP will be displayed in the Current
Meters field on your device.
8. Tap
to pop up the message window.
Select Yes to save the setting.
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Bluetooth indicator on the meter
Mobile Phone Compatibility Issues
The Bluetooth functionality is implemented in different ways by the various mobile phone manufacturers. Unfortunately, in some mobile phone models, even with Bluetooth functionality, they may be compatible only with certain types of devices. If a problem occurs in the connection between your mobile phone and the meter, or if you are uncertain regarding your mobile phoneʼs Bluetooth capabilities, please consult your mobile phone manual or contact your local customer service for assistance.
Bluetooth Indicator Status
Flashing Blue
The Bluetooth function is enabled and waiting for connection.
Solid Blue
The Bluetooth connection is established.
WARNING:
• While the meter is in transmission mode, it will be unable to perform a test.
• Make sure your device with iOS (6 or above) or Android System (4.3 or above) has the Bluetooth function turned on and the meter is within the receiving range before transmitting the data.
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IMPORTANT INFORMATION ABOUT PERFORMING A BLOOD PRESSURE TEST
Before Measurement
Avoid caffeine, tea, alcohol and tobacco for at least 30 minutes before measurement.
Wait for 30 minutes after exercising or bathing before measurement.
Sit or lie down for at least 10 minutes before measurement.
Do not measure when feeling anxious or tense.
Take a 5-10 minute break between measurements. This break can be
longer if necessary, depending on your physical condition
Keep the records for your doctor as reference.
Blood pressure naturally varies between each arm. Always measure
your blood pressure on the same arm.
Apply the Cuff Properly
1. Stretch your left (right) arm in front of you with your palm facing up.
Slide and place the cuff onto your arm, the arrow should point toward the upper arm.
2. Wrap and tighten the cuff above your elbow. The red line on the edge of the cuff should be approximately 0.8” to 1.2” (2 cm to 3 cm) above your elbow.
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3. Leave a little free space between the arm and the cuff; you should be able to fit two fingers between them. Clothing must not restrict the arm. Remove all clothing covering or constricting the measurement arm.
4. Press the hook material firmly against the pile material. The top and bottom edges of the cuff should be tightened evenly around your upper arm.
NOTE:
The cuff is fixed on the blood pressure monitor. Do NOT remove the cuff or change the size of cuff.
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WARNING:
If the cuff is relatively lower (higher) than the heart, the obtained blood pressure value could be higher (lower) than the actual value. A 15 cm difference in height may result in an error around 10 mmHg.
Proper Measurement Position
1. Sit down for at least 10 minutes before measuring.
2. Place your elbow on a flat surface. Relax your hand with the palm
facing up.
3. Make sure the cuff is about the same height as the location of your heart.
4. Remain still and do not talk or move during the measurement.
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2. Pump starts to inflate. The pressure in cuff increases to working pressure.
3. The heart symbol
will show
silently when pulse is detected during the measurement. When signal of pulse becomes strong,
icon starts to
flash.
1. Tap ON/OFF Button. All the LCD symbols will appear with a long beeping sound. Then the cuff will begin to inflate automatically.
NOTE:
When the device detects irregular heart beat, the IRB symbol is shown as
”.
This is for your reference only; if the problem still persists or if you feel uncomfortable, please consult your doctor.
HOW TO TEST YOUR BLOOD PRESSURE
Taking Measurement by the Device Itself
Always apply the pressure cuff before turning on the meter.
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5. Tap ON/OFF Button to switch off. The meter will switch off automatically after being idle for 3 minutes.
4. After the measurement, the meter displays the systolic pressure, diastolic pressure and pulse rate.
NOTE:
• If you tap ON/OFF Button during measurement, the meter will be turned off.
• When the Syn icon appears on the screen, it indicates you have not paired the meter to your mobile device. You need to synchronize with your mobile device in order to adjust the date and time settings. In addition, this measurement will not be stored in meter memory.
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Taking Measurement with the iFORA BP App
All the screenshots displayed below come from the display screen of the Bluetooth receiver installed with iFORA BP App, not from the display screen of the meter.
Single Measurement
1. Turn on the Bluetooth switch on your
mobile device and launch iFORA BP App.
2. Apply the pressure cuff, and tap ON/OFF Button on the iFORA BP screen. All the LCD symbols will appear with a long beeping sound on the device monitor. The cuff will begin to inflate automatically until it reaches the working pressure.
3. The pulse rate is detected during the measurement.
4. After the measurement, the meter displays the systolic pressure,
diastolic pressure and pulse rate.
5. The meter will switch off automatically after being idle for 3 minutes.
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Average Measurement
This function automatically performs three (3) consecutive blood pressure measurements and displays the average result in the end. This function is only available when your meter is connected to your mobile device.
1. Press the Bluetooth button. The PCL icon will appear on the meter display, indicating that the device is ready to transmit data.
2. Launch iFORA BP App.
NOTE:
When the difference between the first and second systolic pressure is more than 15 mmHg, the time interval for third measurement will be 40 seconds.
4. After the first measurement is complete, the device and iFORA BP app will start counting down before the second measurement begins. The device will take three (3) measurements consecutively with an interval of 20 seconds.
3. Select Average Mode and tap ON/OFF Button on the iFORA BP screen. Then the
cuff will begin to inflate automatically.
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5. After taking three measurements, the average result is automatically calculated and displayed on the screen with an
AVG tag.
6. The meter will switch off automatically after being idle for 3 minutes.
NOTE:
• If you tap ON/OFF Button on the iFORA BP screen during measurement, the meter will be turned off.
• Always apply the pressure cuff before turning on the meter.
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VIEWING PREVIOUS RESULTS
Pulse rate data
Blood pressure classification
Share screen data on Facebook or by e-mail
Quick guide
Blood pressure data
Tap to make a personal note
Mark/Unmark Morning measurement
NOTE:
• Swipe horizontally to switch between Morning & All measurements.
• Tap the Blood pressure classification for more details (see Blood pressure classification).
Reviewing Data Record
Your meter stores the 200 most recent blood pressure test results along with respective dates and times in the memory. To recall the memory, you have to connect your FORA Diamond Cuff BP Blood Pressure Monitoring System to your mobile device. Once connected, the measured data is automatically imported to iFORA BP App.
Tap Data on the main menu bar to review the records. The first reading you see is the latest blood pressure result.
Data Record Screen
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Data Record Screen (rotate by 90°)
Rotate by 90° to see your results sorted by Date / Time.
NOTE:
Scroll vertically to view history records.
Measurement mode
Systolic / Diastolic blood pressure
Irregular heart beat
Sunny symbol indicates Morning measurement
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Reviewing Day Average Results
iFORA BP offers you 7-, 14-, and 30- day average results to assist you to monitor your blood pressure.
Tap Analysis on the main menu bar to enter Day Average Results.
Day Average Screen
NOTE:
• Swipe horizontally to switch between Morning & All measurements.
• Tap the Blood pressure classification for more details (see Blood pressure classification).
Distribution of average blood pressure results
Average pulse rate result
Blood pressure classification
Share screen data on Facebook or by e-mail
Switch between 7-, 14-, and 30- day results
Quick guide
Average blood pressure result
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Day Average Screen (rotate by 90°)
Rotate by 90° to see your results in trend graph.
NOTE:
• Scroll horizontally to view older results.
• The function of viewing earlier results is featured in the Bluetooth receiver installed with the iFORA BP.
• The meter itself only displays the latest result after each measurement.
Share screen data on Facebook or by e-mail
Quick guide
Switch between 7-, 14-, and 30- day results
Collapse / Expand sidebar
Day average trend curve
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NOTE:
• The information here is only displayed on the screen of Bluetooth receiver installed with the iFORA BP App.
• The classification is for reference only. Always consult your doctor to have the results interpreted.
Blood Pressure Classication
Under Data Record screen or Day Average screen, you can tap on the Blood pressure classification to enter the single or total result classification.
Here, your blood pressure results are classified by colors based on your Systolic and Diastolic readings, with Red for Stage 2 Hypertension, Orange for Stage 1 Hypertension, Green for Prehypertension, Light Green for Normal and Yellow for too low. The blood pressure classification is based on JNC VII Express (2003).
Red
Orange
Green
Light Green
Yellow
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MAINTENANCE
Battery
Your meter comes with four (4) 1.5 V AAA size alkaline batteries.
Low Battery Signal
The meter will display either of the two messages below to alert you when the meter power is getting low.
Replacing the Battery To replace the batteries, make sure the meter is turned off.
1. Press the edge of the battery cover and lift it up to remove.
2. Remove the used batteries.
3. Replace with four 1.5 V AAA size alkaline batteries in accordance with
the mark +/- indication in the battery compartment.
4. Close the battery cover.
1. The
symbol appears along with
display messages: The meter is functional and the result remains accurate, but it is time to change the batteries.
2. The
symbol appears with E-b: The
power is not enough to do a test. You must change the batteries immediately.
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NOTE:
• As with all small batteries, these batteries should be kept away from small children. If swallowed, promptly seek medical assistance.
• Batteries might leak chemicals if unused for a long time. Remove the batteries if you are not going to use the device for an extended period (i.e., 3 months or more).
• Properly dispose the batteries according to your local environmental regulations.
• Replacing the batteries does not affect the test results stored in memory. However, if you did not synchronize with your mobile device after the battery replacement, the measured data will not be stored in the memory.
Caring for Your Meter
To avoid the meter from attracting dirt, dust or other contaminants, wash and dry your hands thoroughly before use.
Cleaning
To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth. Do NOT flush with water.
Do NOT use organic solvents to clean the meter.
Do NOT wash or iron the pressure cuff.
Meter Storage
Storage condition: -25°C to 70°C (-13°F to 158°F), 10% to 95% relative humidity.
Always store or transport the meter in its original storage case.
Avoid dropping or heavy impact.
Avoid direct sunlight and high humidity.
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DETAILED INFORMATION
Reference Values
Clinical studies show that adult diabetes is often accompanied by elevated blood pressure. People with diabetes can reduce their heart risk by managing their blood pressure along with diabetes treatment
*1
.
Monitoring your routine blood pressure trend helps you to know your body condition. Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous ageing of the blood vessels. Further causes include obesity, lack of exercise and cholesterol (LDL) adhering to the blood vessels. Rising blood pressure accelerates hardening of the arteries, and the body becomes more susceptible to apoplexy and coronary infarction. The recommended blood pressure range is as below:
Classification Systolic Pressure (mmHg) Diastolic Pressure (mmHg)
Hypotension
*2
≤ 90 ≤ 60
Normal
*3
< 120 < 80
Pre-hypertension
*3
120–139 80–89
Stage 1 Hypertension
*3
140–159 90–99
Stage 2 Hypertension
*3
≥ 160 ≥ 100
*1: American Diabetes Association: The Diabetes-Heart Disease Link Surveying Attitudes, Knowledge and Risk (2002). *2: National Heart, Lung, and Blood Institute, Diseases and Conditions. *3: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication. 2003. No. 03-5233.
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SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair by yourself and never try to
disassemble the meter under any circumstances.
Error Messages on Meter
MESSAGE CAUSE WHAT TO DO
Inflation or pressure
error.
Please contact local customer service
for help.
Blood pressure
measurement error.
Refit cuff tightly and correctly. Relax
and repeat the measurement. If error
still remains, contact local customer
service for help.
Problems with the
meter.
Review the instructions and repeat the
test. If the meter still does not work,
please contact the local customer
service for help.
Battery is too low. Repeat with new batteries.
NOTE:
The information here is only displayed on the meter screen.
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Troubleshooting
1. If no display appears after tapping ON/OFF Button:
POSSIBLE CAUSE WHAT TO DO
Batteries exhausted. Replace the batteries.
Batteries incorrectly installed or absent.
Check that the batteries are correctly
installed.
2. If the heart rate is higher/lower than userʼs average:
POSSIBLE CAUSE WHAT TO DO
Movement during measurement. Repeat measurement.
Measurement taken just after exercise.
Rest for at least 30 minutes before
repeating measurement.
4. If the cuff inflates again while measuring:
3. If the result is higher/lower than userʼs average measurement:
POSSIBLE CAUSE WHAT TO DO
May not be in correct position while
measuring.
Blood pressure naturally varies from time
to time.
Blood pressure naturally varies from time
to time.
Keep in mind for next measurement.
POSSIBLE CAUSE WHAT TO DO
Cuff is not fastened. Cuff is not fastened.
If userʼs blood pressure is higher than the pressure the device has inflated, the device
will automatically increase the pressure and start to inflate again. Stay relaxed and
wait for the measurement.
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SPECIFICATIONS
● System Performance
Power Source: Four 1.5 V AAA alkaline batteries Size of Meter w/o Cuff:
145 (L) x 64.5 (W) x 29.6 (H) mm, 240 g (without batteries)
Power Saving: Automatic power off if system idle for 3 minutes Waterproof Grade: IP22
The Expected Service Life: 2 years
System Operating Condition:
5°C to 40°C (41°F to 104°F), 15% to 93% RH, 700 hPa to 1060 hPa
Meter Storage Condition:
-25°C to 70°C (-13°F to 158°F), 10% to 95% RH
● Blood Pressure Measurement Performance
Pressure Range: 0 - 300 mmHg Systolic Measurement Range: 60 mmHg -225 mmHg Diastolic Measurement Range: 30 mmHg -195 mmHg Pulse Rate Measurement Range: 40 -199 beats / minute Maximum Inflation Pressure: 280 mmHg Accuracy of Pressure: ±3 mmHg or ±2% of reading Accuracy of Pulse Rate: ±4% of reading Measurement Unit: mmHg
This device has been tested to meet the electrical and safety requirements of: IEC 60601-1, and IEC 60601-1-2
Reference to Standards:
• IEC60601-1 General requirement for safety
• IEC60601-1-2 Requirements for EMC
IP22:
• Object size protected against: >12.5 mm (Fingers or similar objects)
• Protected against: Dripping water when tilted up to 15°.
NOTE
NOTE
Designed & Authorized by
ForaCare Suisse AG
CH-9000 St. Gallen, Switzerland
www.foracare.ch
TaiDoc Technology Corporation
B1-7F., No. 127, Wugong 2nd Road,
Wugu Dist., 24888 New Taipei City, Taiwan
www.taidoc.com
Blood Pressure Monitoring System
CUFF BP
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