FORA P20 Blood Pressure Monitoring System Owner’s Manual

FORA P20 Blood Pressure Monitoring System

Product Information

Specifications

• Model: FORA P20 Blood Pressure Monitoring System
• Version: 1.0
• Release Date: September 2023
• Product Number: 311-3132200-006

Safety Precautions

1. Supervise device usage around children, handicapped persons, or invalids.
2. Use the device only as intended per the manual.
3. Avoid using unspecified accessories.
4. Keep away from hot surfaces.
5. Avoid use near aerosol sprays or oxygen administration.
6. Do not use if the device is not working properly or damaged.
7. Avoid usage on neonates or infants.
8. Avoid dry environments with synthetic materials to prevent static discharges.
9. Avoid close proximity to strong electromagnetic radiation sources.
10. Maintain and calibrate the device regularly for accurate results.

Product Usage Instructions

Before You Begin

Warnings and Precautions:

• The FORA P20 Blood Pressure Monitoring System is for individuals over 18 years old.
• This device does not cure symptoms or diseases; consult a physician for result interpretation.
• Avoid using the device in cases of common arrhythmia or for non-human blood pressure measurements.

Intended Use:

The FORA P20 measures systolic, diastolic blood pressure, and heart rate using the oscillometric method on the upper arm of individuals over 18 years old.

Principle of Measurement:

Blood pressure is measured non-invasively at the upper arm using the Oscillometric method, providing equivalent results to traditional auscultation methods.

Testing Your Blood Pressure

Before Measurement:

Ensure proper cuff placement and measurement positioning.

Fitting the Cuff Correctly:

Place the cuff securely on your arm following the provided instructions.

Proper Measurement Position:

Position your arm correctly for accurate readings.

Taking Measurements:

Follow the monitor’s instructions to initiate and complete the blood pressure measurement process.

Monitor Memory

Reviewing Test Results:

Access and review past test results stored in the monitor memory.

Downloading the Results

Data Transmission via Bluetooth:

Utilize Bluetooth connectivity to transfer data to compatible devices for further analysis or storage.

Maintenance

Battery:

Ensure proper battery maintenance as instructed in the manual to keep the device functioning optimally.

System Troubleshooting

Error Message:

Refer to the manual for troubleshooting guidance in case of error messages on the monitor.

Troubleshooting:

Follow troubleshooting steps provided in the manual to resolve any operational issues.

Detailed Information

Reference Values:

Refer to the detailed information section for reference values and additional insights related to blood pressure measurements.

FAQs

• Q: Can the FORA P20 be used on infants?
  • A: No, the FORA P20 should not be used on neonates or infants as per safety precautions.
• Q: How often should the device be calibrated?
  • A: Proper maintenance and periodic calibration are essential for accuracy; contact local customer service if concerned about measurement accuracy.

Blood Pressure Monitoring System Sistema de Vigilancia de Presión Arterial
Owner’s Manual Manual del Propietario

English
Dear FORA P20 System Owner:
Thanks for purchasing the FORA P20 Blood Pressure Monitoring System. This manual provides extremely important information which helps you operate this system properly. Before using this product, please read the following contents thoroughly and carefully. Your FORA P20 Blood Pressure Monitoring System provides you with accurate, non-invasive measurement of your blood pressure at your upper arm based on the Oscillometric method. By means of the compact size and ease of operation of this FORA P20 Blood Pressure Monitoring System, you can monitor your blood pressure by yourself simply at any place, any time. Furthermore, the results of measurements you get from this system can help you and your healthcare professionals to monitor and adjust your treatment plan to control your blood pressure better. Please read it carefully.
Version 1.0 2023/09 311-3132200-006

IMPORTANT SAFETY

IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids.
2. Use this device only for the intended use described in this manual.
3. Do not use accessories which are not specified by the manufacturer.
4. Keep the equipment and its flexible cord away from hot surfaces.
5. Do not use the equipment where aerosol sprays are being used, or where oxygen is being administered.
6. Do not use the device if it is not working properly or has been damaged.
7. Do not use under any circumstances on neonates or infants.
8. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets, etc.) may cause damaging static discharges that may cause erroneous results.
9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
10. Proper maintenance and periodic 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.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

BEFORE YOU BEGIN

Warnings and Precautions
The FORA P20 Blood Pressure Monitoring System shall only be used for the testing on people over 18 years of age and over.
This device does NOT serve as a cure for any symptoms or diseases. The data measured are for reference only. Always consult your physician to have the results interpreted.
This device is NOT able to take measurements in the presence of common arrhythmia, such as arterial or ventricular premature beats or arterial fibrillation. It may produce reading error.
Do NOT use the device for purposes other than measuring blood pressure for human beings.
Do NOT apply the cuff to areas other than your arm.
Intended Use
The intended use of FORA P20 Blood Pressure Monitoring System is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the upper arm of the subject. This system should only be used for the testing on people over 18 years of age and over.
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Principle of Measurement
Blood pressure is measured non-invasively at the upper arm based on the Oscillometric method. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers.
Major Features
This system has the following distinguishing features and provides you and your doctor to manage your health effectively. 1. Auscultatory Mode – provide an adjunct function for trained persons to measure blood pressure by hearing. 2. Multiuser function – provide users to store their results in the memory individually.
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Contents of System
The FORA P20 Blood Pressure Monitoring System kit includes:

1 1 x Monitor 2 1 x Owner’s Manual 3 1 x Pressure Cuff

4 1 x Quick Start User Guide / Warranty Card
5 4 x AA Alkaline Batteries
6 1 x Protective Wallet

NOTE: If any items are missing from your kit or opened before use, please contact
local customer service or place of purchase for assistance.

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Monitor Overview

1 Air Jack

8 Up Button

2 Display Screen

9 Bluetooth Indicator

3 Repeat/Pairing Button Press to repeat the voice instructions/pair with personal device.

10 Earphone Jack 11 AC/DC Adapter Port 12 Battery Compartment

4 Set Button (S)

13 Pressure Cuff

5 Main Button (M)

14 Air Tube

6 On/Off Button

15 Air Plug

7 Down Button

NOTE: If you prefer to listen to the voice messages by earphone, plug a pair of
earphones into the earphone jack on the side of your monitor. This monitor has some speaking functions but is not intended for use by the
visually impaired.

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Display Screen

1 Date and Time 2 Systolic Pressure Value 3 Diastolic Pressure Value 4 Auscultatory Mode Symbol 5 User Number 6 Pulse Rate Symbol 7 Pulse Rate 8 Three Time Average

9 Memory Mode Symbol 10 Unit of Measurement (KPa) 11 Diastolic Pressure Symbol 12 Battery Symbol 13 Unit of Measurement
(mmHg) 14 Systolic Pressure Symbol 15 Volume Symbol

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Setting the Monitor
Before using your monitor for the first time, check and update these settings. Make sure you complete the steps below and save the desired settings.
Entering the Setting Mode Start with the monitor off. Press until the monitor turns on.

1. Setting the date With the year flashing, press select the correct year. Press

to .

With the month flashing, press

to

select the correct month. Press .

With the day flashing, press

to

select the correct day. Press .

2. Setting the time format

Press

to select the desired time

format. Press .

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3. Setting the time

With the hour flashing, press

to

select the correct hour. Press .

With the minute flashing, press

to

select the correct minute. Press .

4. Setting the unit of measurement

Press

to select mmHg or Kpa.

Press .

5. Setting the speaking volume
There are seven (7) speaking volume options you can choose from. Press
to select the desired speaking volume. Press .
Volume 0 indicates that the speaking function is turned off, and will not display ” “. Volume 1 to 7 indicates speaking volume from low to high, and ” ” will be displayed during testing.
6. Deleting the memory
While “dEL” and a blinking ” ” symbol appear on the display, if you do not wish to delete the saved results, press to skip this step.

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If you wish to delete ALL the results, press twice. ” ” and ” ” are displayed on the monitor, which indicates that all results have been deleted.

7. Choosing a language

Press

to select L1/L2. The default

language for the monitor is L1 (English).

Press .

Then the monitor will turn off automatically or you can press to turn off the monitor.

Congratulations! You have completed all settings.

NOTE: These settings can ONLY be changed in the setting mode. If the monitor is idle for 3 minutes during the setting mode, it will switch off
automatically.

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TESTING YOUR BLOOD PRESSURE

This monitor provides you three different ways to measure your blood pressure. Select from the operation below: Single measurement
Preform an individual blood pressure measurement. Averaging measurement
Automatically perform three (3) consecutive blood pressure measurements and display the average result at the end. Auscultatory Mode measurement Only trained health-care professionals may use this mode to measure blood pressure manually with a stethoscope by listening to Korotkoff sounds.
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 conditions. Keep the records for your doctor as reference. Blood pressure varies between each arm. Always measure your blood
pressure on the same arm.
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Fitting the Cuff Correctly
1. Connect the air plug of the tubing to the air jack of the monitor.
2. Assemble the cuff as shown on the right. The smooth surface should be inside the cuff loop and the metal D-ring should not touch your skin.
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.
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4. Leave a little free space between the arm and the cuff, you should be able to fit 2 fingers between them. Clothing must not restrict the arm. Remove all clothing covering or constricting the measurement arm.
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. Press . Remain still and do not talk or move during the measurement.
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.
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4. Measurement is in progress.
After the monitor is turned on, the cuff will begin to inflate automatically.

Taking Measurements

This monitor provides you three different ways to measure your blood pressure.
Taking a Single Measurement

Always apply the pressure cuff before turning on the monitor.

1. Press . All the LCD symbols will

appear. Press

to select

user” ” (numbers from 1 to 4)

whose test reading will be stored in

memory. Then the cuff will begin to

inflate automatically.

*Voice: Thank you for using FORA Telehealth product, please relax during measurement.

2. The heart symbol ” ” will flash when a pulse is detected during the inflation.

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

*Voice: Your systolic blood pressure is (number) millimeters of mercury. Your diastolic blood pressure is (number)
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millimeters of mercury. Your heart rate is (number) beats per minute.

4. Press to switch off. Or it will switch off automatically after left idle for 3 minutes.

NOTE: If you press

during measurement, the monitor will be turned off.

If the pulse rate symbol is shown as ” ” instead of ” “, this indicates that

the monitor has detected an irregular heart beat.

Averaging Measurement Mode

Always apply the pressure cuff before turning on the monitor.

1. Press and hold for three seconds.

The monitor will turn on and enter the

averaging mode. Press

to select

user” ” (numbers from 1 to 4)

whose test reading will be stored in

memory and press to confirm. Then

the cuff will begin to inflate

automatically.

*Voice: Thank you for using FORA Telehealth product, please relax during measurement.

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2. After the first measurement is completed, the monitor will start counting down before the second measurement begins. The number on the right represents the remaining countdown between each measurement. The monitor will take three (3) measurements consecutively with intervals of 20 seconds.
3. After taking three measurements, the results are averaged to produce the blood pressure measurement. Press to turn off the monitor.
*Voice: Your systolic blood pressure is (number) millimeters of mercury. Your diastolic blood pressure is (number) millimeters of mercury. Your heart rate is (number) beats per minute.
Auscultatory Mode
Only trained healthcare professionals may perform this manual blood pressure measurement.
This manual method involves applying a stethoscope to patient’s arm and listening to the pulse while the air is slowly let out again.
The systolic pressure is the maximum pressure in an artery at the
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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 patient’s arm where there is a pulse. Apply the cuff to the patient’s upper arm and hold in place with Velcro.
2. Press and wait for the user number to appear. Press to switch to the auscultatory mode. A auscultatory mode symbol will appear on the display with a beep. The cuff begins to inflate automatically. 3. After reaching the cuff pressure, the deflation begins. The operator can adjust the inflation pressure if necessary. During the measurement, press and hold at any time to keep inflating, release at the desired pressure. 4. The systolic pressure is measured when the operator first hears the pulse. Take the reading according to the value on the display. This reading indicates the patient’s systolic pressure. 5. The diastolic pressure is measured from the moment the operator is unable to hear the sound of the pulse. Take the reading according to the value on the display. This reading indicates the patient’s diastolic pressure.
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MONITOR MEMORY

Your monitor stores the 400 most recent test results along with respective date and time in its memory. To enter the monitor memory, start with the monitor switched off.

Reviewing Test Results

1. Press and release

” ” will appear on the display. The user

symbol (numbers from 1 to 4) appears

first, press

to select which one

you used to store in the memory.

2. Press

Review all test results stored in the monitor.

3. Exit the memory

Press and the monitor will turn off.

NOTE: Any time you wish to exit the memory, press or leave it idle for 3 minutes.
The monitor will turn off automatically. If using the monitor for the first time, “—” displays when you recall the test
results or review the average result. This indicates that there is no test result in
the memory.

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DOWNLOADING THE RESULTS

Data Transmission via Bluetooth
You can transmit your measurement data from the monitor to an App on your mobile device via Bluetooth signal. Please note that you must first pair your monitor to your mobile device before attempting to transmit any data. Please contact customer service or the place of purchase for further assistance.
Pairing with your mobile device 1. Press and hold on the monitor until the Bluetooth indicator
starts to flash. 2. On your mobile device, turn on the Bluetooth function and follow
the instruction on the App to pair the device (e.g., Search for monitor to add it into App). 3. After successfully pairing the App to your monitor, the Bluetooth function on the monitor will then start to transmit the data to your App.

Bluetooth indicator on the monitor

BLUETOOTH INDICATOR Flashing Blue Solid Blue

STATUS
The Bluetooth function is enabled and waiting for connection. The Bluetooth connection is established.

NOTE: While the monitor is in transmission mode, it will be unable to perform a test. Make sure that your Bluetooth enabled device has turned on the Bluetooth
signal prior to transmitting the data, and that the monitor is within range. For OS version requirements please refer to the App description on the Apple
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App Store or Google Play Store. A compatibility issue between your mobile device and the monitor might occur
due to the way Bluetooth functionality is implemented by the various mobile device manufacturers.
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MAINTENANCE

Battery
Your monitor comes with four 1.5V AA size alkaline batteries. Low Battery Signal The monitor will display the message below to alert you when the monitor power is getting low.
The ” ” appears along with display messages: The monitor is functional and the result remains accurate, but it is time to change the batteries.
The ” ” appears with E-b and low: The power is not enough to do a test. Please change the batteries immediately.
Replacing the Battery To replace the batteries, make sure that the monitor is turned off.
1. Press the edge of the battery cover and lift it up to remove. 2. Remove the old batteries and replace it with four 1.5V AA size
alkaline batteries. 3. Close the battery cover.
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NOTE: Do not use different type, date or brand name batteries together. Use only new
batteries of the required size and type. Replacing the batteries does not affect the test results stored in the memory. As with all small batteries, these batteries should be kept away from 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 of the batteries according to your local environmental regulations.
Connect AC adapter to the monitor 1. Connect AC adapter plug to AC adapter jack of the monitor.
2. Plug AC adapter power plug into an electrical outlet. The monitor is ready for use.
Remove AC adapter from the monitor 1. When the monitor is off, remove AC adapter plug from the electrical outlet.
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2. Disconnect AC adapter plug from AC adapter jack on the monitor.
To prevent the monitor from dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning To clean the monitor 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 it with water. Do NOT use organic solvents to clean the monitor. Do NOT wash the pressure cuff. Do NOT iron the pressure cuff.
Monitor Storage Storage condition: -4°F to 140°F (-20°C to 60°C), below 95% relative
humidity. Always store or transport the monitor in its original storage case. Avoid dropping and heavy impact. Avoid direct sunlight and high humidity.
Monitor Disposal The batteries in this used monitor should be removed and the monitor should be disposed in accordance with local regulations.
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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 yourself and never try to disassemble the monitor under any circumstances.

Error Message

MESSAGE
E-1 E-2

WHAT IT MEANS Inflation or pressure error. Deflation error.

E-4

Blood pressure measurement error.

E-b
E-E E-A E-3 E-C

Battery is too low. Problem with the monitor.

WHAT TO DO
Please contact local customer service for help.
Refit cuff tightly and correctly. Relax and repeat measurement. If error still exists, please contact the local customer service for help.
Replace the batteries or connect 6V AC/DC adapter.
Review the instructions and repeat the test. If the monitor still does not work, please contact the local customer service for help.

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Troubleshooting

1. If nothing is display after pressing :

POSSIBLE CAUSE
Battery exhausted. Batteries incorrectly installed or absent.

WHAT TO DO
Replace the batteries. Check that the batteries are correctly installed.

2. If the heart rate is higher/lower than user’s average:

POSSIBLE CAUSE Movement during measurement.
Measurement taken just after exercise.

WHAT TO DO Repeat measurement.
Rest at least 30 minutes before repeating measurement.

3. If the result is higher/lower than user’s average measurement:

POSSIBLE CAUSE
May not be in correct position while measuring.
Blood pressure naturally varies from time to time.

WHAT TO DO Adjust to the correct position to measure.
Keep in mind for next measurement.

4. If the cuff inflates again while measuring:

POSSIBLE CAUSE

WHAT TO DO

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.

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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.

Knowing your routine blood pressure trend tells you whether your body is in good condition or not. Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous aging 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 presented below:

Classification
Hypertension*2

Systolic Pressure (mmHg)
< 90

Diastolic Pressure (mmHg)
< 60

Normal*3

< 120

< 80

Elevated*3

120 – 129

< 80

Stage 1 Hypertension3 Stage 2 Hypertension3 Hypertensive Crisis*3

130 ­ 139 140 180

80 ­ 89 90 120

Reference
1: National Heart, Lung, and Blood Institute, Diseases and Conditions.
2: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication. 2003. No. 03-5233
*3: New ACC (American College of Cardiology) and AHA (American Heart Association) guidelines for the detection, prevention, management and treatment of high blood pressure (2017).

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SPECIFICATIONS

Model No.: FORA P20 Dimension: 152 (L) x 99 (W) x 55 (H) mm Weight: 280 g (without battery) Power Source: four 1.5V AA alkaline batteries Display: LCD Memory: 400 measurement results (100 per user) External Output: Bluetooth Power Saving: Automatic power off if system is idle for 3 minutes (normal mode) or 5 minutes (RF mode)
System Operating Condition: 50°F to 104°F (10°C to 40°C), below 85% R.H. Monitor Storage/Transportation Conditions: -4°F to 140°F (-20°C to 60°C), below 95% R.H. Power Supply Input: DC +6V / 1A (max) via Power Plug Expected Service Life: 3 years
Blood Pressure Measurement Performance Pressure Range: 0 ­ 300 mmHg Measurement Unit: mmHg or KPa Systolic Measurement Range: 60 ­ 255 mmHg Diastolic Measurement Range: 30 ­ 195 mmHg Pulse Rate Measurement Range: 40 ­ 199 beats / minute Maximum Inflation Pressure: 300 mmHg Accuracy of Pressure: ±3 mmHg or ±2% of reading Accuracy of Pulse Rate: ±4% of reading
This device has been tested to meet the electrical and safety requirements of: IEC/EN 60601-1, IEC/EN 60101-1-2, EN 300 328.
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Reference to Standards: EN 1060-1 /-3, NIBP-requirements IEC60601-1 General requirement for safety IEC60601-1-2 Requirements for EMC EN1060-4, NIBP clinical investigation AAMI / ANSI / IEC 80601-2-30, ANSI/AAMI/ISO 81060-2, NIBP
requirements FCC part 15C
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FCC

FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT
15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.
15.105(b) Federal Communications Commission (FCC) Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) This device may not cause harmful interference and 2) This device must accept any interference received, including interference that may cause undesired operation of the device.
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FCC RF Radiation Exposure Statement: 1) This transmitter must not be co- located or operating in conjunction with any other antenna or transmitter. 2) This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator and your body.
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References

• ForaCare – The New Leader in Medical Device Technology

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