FORA CUFF BP Blood Pressure Monitoring System Owner’s Manual

FORA CUFF BP Blood Pressure Monitoring System

Safety Information

Read the following Safety Information thoroughly before using the device.

• Use this device ONLY for the intended use described in this manual.
• Do NOT use accessories which are not specified by the manufacturer.
• Do NOT use the device if it is not working properly or damaged.
• Do NOT use under any circumstances on newborns, infants, or persons who cannot communicate.
• This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. Always consult your physician to have the results interpreted.
• Keep the equipment away from hot surfaces.
• Do NOT apply the cuff to areas other than the place directed.
• Proper maintenance and periodically calibration are essential to the longevity of your device. If you are concerned about your accuracy of measurement, please contact local customer service for help.
• If you experience any serious incident that occurred in relation to the use of this product, please report it to the manufacturer and the competent authority of medical devices in your country.
• A serious incident means any incident that directly or indirectly led, might have led, or might lead to any of the following:\
  • the death of a patient, user, or other people,
  • the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
  • a serious public health threat.

Introduction

Intended Use
The Diamond CUFF BP Blood Pressure Monitoring System is intended to be used 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. The device also works in unison with iFORA BP app that enables transmission and sharing capabilities via Bluetooth. Do not use this system on babies, young children or persons who cannot express their consent.

Test Principle
Blood pressure is measured non-invasively at the arm based on oscillometric method. The reading obtained by single and average mode which use oscillometic method is for reference only.

Product Overview

1. Bluetooth LED Indicator
2. Pressure Cuff
3. Screen Display
4. Battery Compartment Cover
5. Power Button
6. Bluetooth Button

Screen Display

1. Systolic Pressure Value
2. Diastolic Pressure Value
3. IRB (Irregular Rapid Beat) Symbol
4. Low Battery Symbol
5. Units for Blood Pressure
6. Systolic Pressure Symbol
7. Units for Blood Pressure
8. Diastolic Pressure Symbol
9. Pulse Rate
10. Pulse Rate Symbol

Getting Started

Installing the Batteries
Before using the device for the first time, please install four 1.5V AAA size alkaline batteries.

1. Push down the battery compartment cover to open it.
2. Align the batteries contacts and then insert the batteries into the battery compartment.
3. Close the battery compartment cover.

Installing the APP

With iFORA BP app, you can use your mobile device to track your blood pressure trends and share the progress across an Android or iOS mobile device. Download and install iFORA BP app from Play Store/App Store. The iFORA BP app icon ( the installation is complete.

Pairing with Your Mobile Device
To pair your Diamond CUFF BP with your mobile device, do the following:

1. Press and hold the Bluetooth button for at least 3 seconds.
2. On your mobile device, activate the Bluetooth function. Then search for “DIAMOND CUFF BP“.
3. Tap DIAMOND CUFF BP to start pairing. The Bluetooth LED indicator will blink during the pairing process.
4. When pairing is complete, the main screen appears on the mobile device’s screen.

Note:

• If the device is left idle for 3 minutes, it will turn off automatically.
• The Bluetooth pairing process is only required when user needs to pair this device to a Bluetooth receiver for the first time, or when user needs to pair this device to another new Bluetooth receiver.

Testing Your Blood Pressure

Before Measument

• Avoid caffeine, tea, alcohol and tobacco for at least 30 minutes before measurement.
• Wait 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 conditions.
• Keep the records for your doctor as reference.
• Blood pressure varies between each arm. Always measure your blood pressure on the same arm.

Fitting the Cuff

Assemble the cuff.
The smooth surface should be inside the cuff loop and the metal D-ring should not touch your skin.

Note:
Before using the cuff, be sure the cuff size fits with your upper arm circumference.

1. Stretch your left (right) arm in front of you with your palm facing up. Slide and place the cuff onto your arm with the artery mark region (in red) toward the lower arm. Wrap and tighten the cuff above your elbow. The red line on the edge of the cuff should be approximately 2 to 3 cm (0.8 to 1.2 inches) above your elbow
2. Leave a little free space between the arm and the cuff. You should be able to fit 2 fingers between them.
3. 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.

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. Press the Power button.

Measuring Blood Pressure

This device provides you different ways to measure your blood pressure. When the device detects an irregular heart beat, the IRB symbol is shown as instead of . If the problem still persists, please consult your doctor.

Single Measurement
Perform an individual blood pressure measurement.

1. Press the Power button. All the LCD symbols will appear. Then the cuff will begin to inflate automatically
2. The heart symbol will flash when a pulse is detected during the inflation.
3. Press the Power button to turn the device off ****

Average Measurement (via APP)
Automatically performs three (3) consecutive blood pressure measurements and displays the average result in the end. This function is only available when your Diamond CUFF BP is connected to your mobile device

1. Press the Bluetooth button. The “ “ icon will appear on the display, indicating that the device is ready to transmit data.
   Important!
   Be sure the device is properly connected to your mobile device via Bluetooth

2. Launch iFORA BP app. The main screen appears on the mobile device’s screen.

3. Set Average Mode to ON and tap . Then the cuff will begin to inflate automatically.

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

5. After taken three measurements, the test result is displayed on the screen. Press the Power button to turn the device off.

Reviewing Test Results
Your device 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 Diamond CUFF BP to your mobile device. Once connected, the measured data is automatically imported to iFORA BP app.

Appendix

Maintenance
When the battery is low, one of the following screen will appear

• the icon appears with display messages:
• This indicates the device is functional and the result remains accurate, but it is time to change the batteries. the icon appears with E-b:
• This indicates the power is not enough for a measurement. You must change the batteries immediately

To change the batteries, do the following:

1. Push down the battery compartment cover to open it.
2. Remove the old batteries and replace with four 1.5V AAA size alkaline batteries.
3. Close the battery compartment cover

CAUTION
RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE. DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS.

Note:

• When the icon appears on the screen, it indicates that 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.
• 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.
• Keep away these batteries from small children. If swallowed, promptly seek medical assistance.
• Batteries may leak chemicals if unused for a long time. Remove the batteries if you are not going to use the device for an extended period.
• Properly dispose of the used batteries according to your local environmental regulations.

Caring for Your Device

• To clean the device 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 device.
• Do NOT wash or iron the pressure cuff.

Device Storage

• Storage condition: -25°C to 70°C, within 10%~95% relative humidity.
• Always store or transport the device in its original storage case.
• Avoid dropping and heavy impact.
• Avoid direct sunlight and high humidity.

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

Blood Pressure Measurement

Nothing is displayed after pressing the Power button.

| Batteries exhausted.| Replace the batteries.
Batteries incorrectly installed or no battery is installed.| Check that the batteries are correctly installed.

The heart rate is higher/lower than user’s average.

| Movement during measurement.| Repeat measurement.

Measurement taken just after exercise.

| Rest at least 30 minutes

before repeating

measurement.

The result is higher/ lower than user’s average measurement.

| May not be in correct position while measuring.| Adjust to the correct position to measure.
Blood pressure naturally varies from time to time.| Keep in mind for next measurement.

Reference Values

Blood Pressure
Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous ageing of the blood vessels. Further causes include diabetes, 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. Definitions and Classification of blood pressure levels according to 2007 ESH-ESC Practice Guidelines for the Management of Arterial Hypertension:

Isolated systolic hypertension should be graded (1, 2, 3) according to systolic blood pressure values in the ranges indicated, provided that diastolic values are < 90 mmHg. Source: The European Society of Hypertension and European Society oF Cardiology Task Force Members. 2007 ESH-ESC Practice Guidelines for the Management of Arterial Hypertension. J Hypertens 2007; 25: 1751-1762.

Symbol Information

Specifications

System performance

Power Source| Four 1.5V AAA alkaline batteries
Dimensions (w/o cuff)| 145 (L) x 64.5 mm (W) x 29.6 mm (H)
Weight (w/o cuff)| 240g (without batteries)
Cuff Size| 24-43 cm (9.4 – 16.9 inches)
Memory| Maximum 200 memory records
Power Saving| Automatic power off if system is idle for 3 minutes
Operating Conditions| Temperature: 5°C ~ 40°C Humidity: 15% ~ 93%
Storage Conditions| Temperature: -25°C ~ 70°C Humidity: 10% ~ 95%
Blood pressure measurement performance
Measurement unit| mmHg
Systolic Measurement Range| 50 ~ 250 mmHg
Diastolic Measurement Range| 30 ~ 180 mmHg
Pulse Rate Measurement Range| 40 -199 beats / minute
Accuracy of Pressure| ±3 mmHg or ±2% of reading
Accuracy of Pulse Rate| ±4% of reading

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants to the original purchaser that, at time of delivery, each standard product manufactured by ForaCare Suisse shall be free of defects in material and workmanship and, when used for the purposes and indications described on the labeling, is fit for the purposes and indications described on the labeling. All warranties for a product shall expire as of the product expiration date, or if none, after one (1) year from the date of shipment from ForaCare Suisse. ForaCare Suisse warranty hereunder shall not apply if: (i) a product is not used in accordance with its instructions or if it is used for a purpose not indicated on the labeling; (ii) any repairs, alterations or other work has been performed by Buyer or others on such item, other than work performed with ForaCare Suisse’s authorisation and according to its approved procedures; or (iii) the alleged defect is a result of abuse, misuse, improper maintenance, accident or the negligence of any party other than ForaCare Suisse. The warranty set forth herein is conditioned upon proper storage, installation, use and maintenance in accordance with applicable written recommendations of ForaCare Suisse. The warranty furnished hereunder does not extend to damage to items purchased hereunder resulting in whole or in part from the use of components, accessories, parts or supplies not furnished by ForaCare Suisse

References

• ForaCare Suisse AG - Comprehensive Disease Management Solutions

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