FORA P30 Plus Series Blood Pressure Monitoring System Owner’s Manual

FORA P30 Plus Series 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 and its flexible cord 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.
  KEEP THESE INSTRUCTIONS IN A SAFE PLACE

Introduction

Intended Use

The FORA ACTIVE Series Multi-mode 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. 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 oscillometer method. For people of common arrhythmia, such as atrial or ventricular premature beats or atrial fibrillation we recommend to use auscultatory mode. The reading obtained by single and average mode which use oscillometer method is for reference only and should be discussed with the healthcare professionals.

Product Overview

1. Screen Display
2. M Button
3. M/Bluetooth Button
4. ON/OFF Button
5. AVG/S Button
6. Bluetooth LED Indicator
7. Battery Compartment
8. AC Adapter Port
9. Air Jack
10. Pressure Cuff
11. Air Tube
12. Air Plug

Screen Display

1. Date
2. Time
3. Systolic Pressure Symbol
4. Systolic Pressure Value
5. Low Battery Symbol
6. Diastolic Pressure Symbol
7. Diastolic Pressure Value
8. Day- / Night-Time Symbol
9. Day Average Symbol
10. Units for Blood Pressure
11. Memory Mode Symbol
12. IRB (Irregular Rapid Beat) Symbol
13. Pulse Rate

Getting Started

Before using the device for the first time, do the following initial setup:

Step 1: Enter the Setting Mode
Press and hold for 3 seconds until the device turns on.

Step 2: Configuring the Settings (Date, Time, Time Format, Memory Deletion, and Bluetooth Pairing (P30 Plus BT only))
Press repeatedly to adjust the value or enable/disable the setting. Then press / to confirm the setting and switch to another field.
Note:

• During memory deletion, do the following:
  • To keep all saved results, press to keep the saved result.
  • To delete all results, press M to delete all memory.
• These parameters can ONLY be changed in the setting mode.
• If the device is idle for 3 minutes during the setting mode, 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. The Bluetooth LED Indicator will blink during the pairing process.
• After the device has been paired with a Bluetooth receiver, press and hold for 3 seconds to start the Bluetooth connection.

Testing Your Blood Pressure

Before Measurement

• 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

1. Connect the air plug of the tubing to the air jack of the device.

2. 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.

3. Stretch your left (right) arm in front of you with your palm facing up. Slide and place the cuff onto your arm with the air tube and 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 0.8 to 1.2 inches (2 to 3 cm) above your elbow. Align the tube over the main arteries on the inside.
   

4. Leave a little free space between the arm and the cuff. You should be able to fit 2 fingers between them.

5. 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.

Important!
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.

4. Press POWER button. The device will turn on and the cuff will begin to inflate automatically. Remain still and do not talk or move during the measurement.

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. If the problem still persists, please consult your doctor.
Important!
Always apply the pressure cuff before turning on the device.

• A. Single Measurement
  Perform an individual blood pressure measurement.

1. Press 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. After the measurement, the monitor displays the systolic pressure, diastolic pressure and pulse rate.

3. Press POWER button to turn the device off.

Note: If the device is idle for 3 minutes, it will turn off automatically.

• B. Average Measurement
  Automatically performs three (3) consecutive blood pressure measurements and displays the average result in the end.

1. Press POWER button. The device will turn on and enter the averaging mode. Then the cuff will begin to inflate automatically.
2. After the first measurement is complete, the device will start counting down before the second measurement begins. The device will take three (3) measurements consecutively with an interval of 20 seconds.

Note:
When the difference between the first and second systolic pressure is more than 15mmHg, the time interval for third measurement will be 40 seconds.

3. After taken three measurements, the results are averaged to produce the blood pressure measurement with AVERAGE symbol display on the screen. Press POWER button to turn the device off.  

• C. Auscultatory Mode
  Only well trained persons may use this mode to measure blood pressure manually. This manual method involves applying a stethoscope to the arm and listening to the pulse while the air is slowly let out from the cuff (the Korotkoff method). Please ask your health-care professional to train you how to use auscultatory mode.
  The systolic pressure is the maximum pressure in an artery at the moment when the heart is beating and pumping blood through the body. The diastolic pressure is the lowest pressure in an artery in the moments between beats when the heart is resting.

1. Place a stethoscope on the arm where there is a pulse. Wrap the cuff around the upper arm and hold in place with Velcro.
2. Press and hold POWER button until “AUS” symbol appears on the display with a beep. Release the button. Then cuff begins to inflate automatically.  

3. After reaching the cuff pressure, the deflation begins. You can adjust the inflation pressure by keep pressing to inflate if necessary. If you release , the inflation will stop and deflation begins.
4. The systolic pressure is measured when the operator first hears the pulse. Write down the value on the display. This value indicates the systolic pressure. You have to record the values as the result will not be stored in the memory.
5. The diastolic pressure is measured from the moment the operator is unable to hear the sound of the pulse. Write down the value on the display. This value indicates the patient’s diastolic pressure. You have to record the values as the result will not be stored in the memory.
6. The device will return to 0 mmHg after the measurement is completed. To turn off the device, press and hold POWER button or it will switch off automatically after idle for 3 minutes.  

Reviewing Test Results

Your device stores the 200 (P30 Plus BT only) most recent blood pressure test results along with respective dates and times in the memory. To recall the memory, start with the device off.
For P30 Plus
To review all test results, do the following:

1. Press and release M. The “M” icon appears on the screen and the first reading you see is the last blood pressure result along with date and time.
   

2. Press M repeatedly to review other test results stored in the device.
   

To review the day-average test results, do the following:

1. Press and hold M for 3 seconds until the “Day Average” icon appears on the screen.

2. Press M and the Day average result appears on the display.
   

3. Press M again to review the Day-time average result.
   

4. Press M again to review the Night-time average result.
   

For P30 Plus and P30 Plus BT

Press M to review the average and general memory recall mode.
Note:

• Day-time average is the average of the measurements taken during 4:00 A.M. to 11:59 A.M.
• Night-time average is the average of the measurements taken during 6:00 P.M. to 11:59 P.M.
• Press POWER button to exit the memory mode or leave it without any action for 3 minutes. The device will turn off automatically.
• If using the device for the first time, the “—” icon appears when you recall the test results or review the average result. It indicates that there is no test result stored in the memory.

Classification of 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.

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.

Definitions and Classification of blood pressure levels according to 2007 ESH- ESC Practice Guidelines for the Management of Arterial Hypertension:

Category

| Systolic|  |

Diastolic

---|---|---|---
Optimal|

< 120 mmHg

| and|

< 80 mmHg

Normal|

120 –129 mmHg

| and/or|

80–84 mmHg

High normal|

130 –139 mmHg

| and/or|

85–89 mmHg

Grade 1 hypertension|

140 –159 mmHg

| and/or|

90– 99 mmHg

Grade 2 hypertension|

160 –179 mmHg

| and/or|

100–109 mmHg

Grade 3 hypertension|

≥ 180 mmHg

| and/or|

≥ 110 mmHg

Isolated systolic hypertension|

≥ 140 mmHg

| and|

< 90 mmHg

Isolated systolic hypertension should be graded (1, 2, 3) according to systolic blood pressure values in the ranges indicated, provided that diastolic values are < 90mmHg.
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.

Maintenance

Changing Battery

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. Press the edge of the battery cover and lift it up to remove the cover.
2. Remove the old batteries and replace with four 1.5V AA size alkaline batteries.
3. Close the battery cover.

CAUTION

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

Note:

• Replacing the batteries does not affect the test results stored in 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.

Using an AC Adapter

You can use an AC adapter to provide the power supply.
To use an AC adapter, do the following:

1. Connect one end of the AC adapter to the AC adapter jack of the device.
   

2. Plug the other end of the AC adapter into an electrical outlet.
   

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: -20°C to 60°C (-4°F to 140°F), below 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.

Error Message

Error Message

| Cause|

What To Do

---|---|---
| Inflation or pressure error.| Please contact local customer service for help.
| Deflation error.| Please contact local customer service for help.
| Blood Pressure measurement error.| Refit cuff tightly and correctly. Relax and repeat the measurement. If the error still remains, please contact local customer service for help.
| Battery is too low.| Replace the batteries or use the AC adapter.
| Problem with the device.| Please contact local customer service for help.

Blood Pressure Measurement

Symptom

| Cause|

What To Do

---|---|---
Nothing is displayed after pressing| 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.
The cuff inflates again while measuring.| Cuff is not fastened.| Fasten the cuff again.
If user’s 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.

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants to the original end-user purchaser that, at time of delivery, each standard product manufactured by ForaCare Suisse shall be free of defects in material and workmanship, and the purposes and indications described on the labelling is consistent with the labelling if the product is used in accordance with the purposes and indications on the labelling.
All warranties for the product, excluding the cuff, shall expire as of
the product expiration date, or if none, after three (3) years from the original date of purchase, as long as it has not been modified, altered, or misused. The cuff is covered by a one (1) year limited warranty. ForaCare Suisse warranty hereunder shall not apply if:

1. a product is not used in accordance with its instructions or if it is used for a purpose not indicated on the labeling;
2. any repairs, alterations or other work has been performed by the buyer or others on such item, other than work performed with ForaCare Suisse’s authorization and according to its approved procedures; or
3. 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 by ForaCare Suisse. The warranty furnished hereunder does not extend to damaged items purchased hereunder resulting in whole or in part from the use of components, accessories, parts or supplies not furnished by ForaCare Suisse.

Appendix

Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to the EMC information provided. Careful consideration of this information is essential when stac king or collocating equipment and when routing cables and accessories.
Warning: RF mobile communications equipment can affect medical electrical equipment.

Recommended Separation Distance Between
Portable and Mobile RF Communications Equipment and the FORA P30 Plus Series

The FORA P30 Plus Series is intended for use in an electromagnetic environment (for home healthcare and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the FORA P30 Plus Series can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and the FORA P30 Plus Series as recommended below, depending on the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

| Separation distance according to frequency of transmitter (m)
---|---
150 kHz to 80 MHz
d =1,2√ P| 80 MHz to 800 MHz
d =1,2√ P|

800 MHz to 2,7 GHz
d =2,3√ P

0,01

| N/A| 0,12| 0,23
0,1| N/A| 0,38|

0,73

1

| N/A| 1,2| 2,3
10| N/A| 3,8|

7,3

100

| N/A| 12|

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) depending on the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Manufacturer’s Declaration-Electromagnetic Emissions

The FORA P30 Plus Series is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.

The customer or the user of the FORA P30 Plus Series should assure that it is used in such an

environment.

Emission test

| Compliance| Electromagnetic environment-guidance (for home healthcare and professional healthcare)

RF emissions CISPR 11

|

Group 1

| The FORA P30 Plus Series uses RF energy only for internal use. Therefore, its RF emissions are very low and are not likely to cause any interference from nearby electronic equipment.

RF emissions CISPR 11

|

Class B

| The FORA P30 Plus Series is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

|

Not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

|

Not applicable

Manufacturer’s Declaration-Electromagnetic Immunity

The FORA P30 Plus Series is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of the FORA P30 Plus Series should assure that it is used in the environment specified below.

Immunity Test

| IEC 60601 Test Level| Compliance Level|

Electromagnetic Environment-Guidance

Electrostatic discharge (ESD) IEC 61000-4-2| Contact: ±8 kV
Air ±2 kV, ±4 kV,
±8 kV, ±15 kV| Contact: ±8 kV
Air ±2 kV, ±4 kV,
±8 kV, ±15 kV| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient / burst IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input / output lines| Not applicable Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment.
Surge IEC 61000-4-5| ±0.5 kV, ±1 kV line(s) to line(s) ±0.5 kV,
±1 kV, ±2 kV line(s) to earth| Not applicable Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Voltage dips:
0 % U T; 0,5 cycle
0 % U T; 1 cycle 70 % U T; 25/30 cycles

Voltage interruptions:
0 % U T; 250/300 cycle

| Voltage dips: Not applicable Not applicable Not applicable

Voltage interruptions: Not applicable

| Mains power quality should be that of a typical home healthcare and professional healthcare environment. If the user of the FORA P30 Plus Series requires continued operation during power mains interruptions, it is recommended that the FORA P30 Plus Series be powered from an uninterruptible power supply or a battery.
Power frequency(50, 60 Hz) magnetic field IEC 61000-4-8| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 Hz and 60 Hz| The FORA P30 Plus Series power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare and professional healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Manufacturer’s Declaration-Electromagnetic Immunity

The FORA P30 Plus Series is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of the FORA P30 Plus Series should assure that it is used in the environment specified below.

Immunity Test

| IEC 60601 Test Level| Compliance Level|

Electromagnetic Environment-Guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| 3 Vrms:
0,15 MHz – 80 MHz
6 Vrms: in ISM and am-ateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

| Not applicable

Not applicable

10 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz

| Portable and mobile RF communications equipment must not be used close to any parts of the FORA P30 Plus Series including cables, other than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:
d = 1,2 √ P
d = 1,2 √ P 80MHz to 800 MHz
d = 2,3 √ P 800MHz to 2,7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FORA P30 Plus Series is used exceeds the applicable RF compliance level above, the FORA P30 Plus Series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the FORA P30 Plus Series.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Manufacturer’s declaration-electromagnetic immunity

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

The FORA P30 Plus Series is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of the FORA P30 Plus Series should assure that it is used in such an environment.

Test Frequency (MHz)

| Band a) **(MHz)| Service a)| Modulation b)| Maximum power (W)| Distance (m)| IMMUNITY TEST LEVEL (V/m)**|

Compliance LEVEL (V/m)

385| 380 – 390| TETRA 400| Pulse modulation b) 18 Hz| 1,8| 0,3| 27| 27
450| 430 – 470| GMRS 460, FRS 460| FM c)
±5 kHz deviation 1 kHz sine| 2| 0,3| 28| 28
710| 704 – 787|

LTE Band 13, 17

|

Pulse modulation b) 217 Hz

| 0,2| 0,3| 9| 9
745
780
810| 800 – 960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation b) 18 Hz| 2| 0,3| 28| 28
870
930
1720| 1700 – 1990| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1, 3,

4, 25; UMTS

| Pulse modulation b) 217 Hz| 2| 0,3| 28| 28
1845
1970
2450| 2400 – 2570| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

| Pulse modulation b)

217 Hz

| 2| 0,3| 28| 28
5240| 5100 – 5800| WLAN 802.11 a/n| Pulse modulation b) 217 Hz| 0,2| 0,3| 9| 9
5500
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

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