ForaCare FORA P30 Plus User manual

ACTIVE P30 Plus Series
ForaCare Suisse AG
Neugasse 55, 9000 St. Gallen, Switzerland
www.foracare.ch
FORA P30 Plus / FORA P30 plus BT
For self-testing / Zur Selbstmessung /
Pour l’automesure / Per l’automisurazione /
Para autotest / Para auto-teste / Voor zelftest /
Pentru autotestare / Pro vlastní testování /
Na domáce meranie /
MedNet EC-REP GmbH
Borkstraβe 10, 48163 Mϋnster,
Germany
Blood Pressure Monitoring System
Blutdrucküberwachungssystem
Système de surveillance de la tension artérielle
Sistema per il monitoraggio della pressione sanguigna
Sistema de supervisión de presión en sangre
Sistema de monitorização de pressão arterial
Bloeddrukbewakingssysteem
Sistem de monitorizare a tensiunii arteriale
Tonometr
Tonometer
Owner’s Manual
Bedienungsanleitung
Manuel de l’utilisateur
Manuale dell’utente
Manual del propietario
Manual do utilizador
Gebruikershandleiding
Manual de utilizare
Příručka vlastníka
Návod na použitie

Contents
Safety Information 1
Introduction 1
Intended Use 1
Test Principle 1
Product Overview 2
Screen Display 2
Getting Started 3
Testing Your Blood Pressure 4
Fitting the Cu 4
Proper Measurement Position 4
Measuring Blood Pressure 5
Reviewing Test Results 7
Classication of Blood Pressure 8
Maintenance 8
Changing Battery 8
Using an AC Adapter 9
Caring for Your Device 9
Device Storage 9
Troubleshooting 10
Error Message 10
Blood Pressure Measurement 11
Symbol Information 11
Specications 11
WARRANTY TERMS AND
CONDITIONS 12
Appendix 12

EN-1
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 specied 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 exible cord away from hot
surfaces.
• Do NOT apply the cu 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:
(a) the death of a patient, user, or other people,
(b) the temporary or permanent serious deterioration of a
patient’s, user’s or other person’s state of health,
(c) 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 inatable cu 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
oscillometric method. For people of common arrhythmia, such
as atrial or ventricular premature beats or atrial brillation we
recommend to use auscultatory mode. The reading obtained
by single and average mode which use oscillometic method is
for reference only and should be discussed with the healthcare
professionals.

EN-2
Product Overview
1
6
3
7
9
8
12
11
10
42 5
P30 Plus BT P30 Plus
1. Screen Display 7. Battery Compartment
2. M Button 8. AC Adapter Port
3. M/Bluetooth Button 9. Air Jack
4. ON/OFF Button 10. Pressure Cu
5. AVG/S Button
6. Bluetooth LED Indicator
11. Air Tube
12. Air Plug
Screen Display
1
7
4
2
1310
11 12
8
6
5
9
3
1. Date 8. Day- / Night-Time Symbol
2. Time 9. Day Average Symbol
3. Systolic Pressure Symbol 10. Units for Blood Pressure
4. Systolic Pressure Value 11. Memory Mode Symbol
5. Low Battery Symbol 12. IRB (Irregular Rapid Beat)
Symbol
6. Diastolic Pressure Symbol
7. Diastolic Pressure Value 13. Pulse Rate

EN-3
Getting Started
Before using the device for the rst 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: Conguring 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 conrm the setting and switch to
another eld.
Set [Year] Set [Month] Set [Day]
Set [Time Format] Set [Minute] Set [Hour]
Memory Deletion Pair Bluetooth
(For P30 Plus BT only)
Note:
• During memory deletion, do the following:
9To keep all saved results, press / to keep the saved result.
9To delete all results, press 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 o automatically.
• The Bluetooth pairing process is only required when user needs to
pair this device to a Bluetooth receiver for the rst 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.

EN-4
Testing Your Blood Pressure
Before Measument
• Avoid caeine, 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 Cu
1. Connect the air plug of the tubing to
the air jack of the
device.
2. Assemble the cu.
The smooth surface should be inside
the cu loop and the metal D-ring should not touch your skin.
Note:
• Before using the cu, be sure the cu size ts with your upper
arm circumference.
3. Stretch your left (right) arm in front of you with your palm
facing up. Slide and place the cu onto your arm with the air
tube and artery mark region (in red) toward the lower arm.
Wrap and tighten the cu above your elbow. The red line on
the edge of the cu 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.
2
~3cm
(0.8”~1.2”)
4. Leave a little free space between the arm and the cu. You
should be able to t 2 ngers between them.
5. Press the hook material rmly against the pile material. The
top and bottom edges of the cu 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 at surface.
Relax your hand with the
palm facing up.
3. Make sure the cu is about the same
height as the location of your heart.

EN-5
Important!
If the cu is relatively lower (higher) than the heart, the
obtained blood pressure value could be higher (lower) than
the actual value. A 15 cm dierence in height may result in an
error around 10 mmHg.
4. Press . The device will turn on and the cu will begin to
inate automatically. Remain still and do not talk or move
during the measurement.
Measuring Blood Pressure
This device provides you dierent 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.
Important!
Always apply the pressure cu before turning on the device.
A. Single Measurement
Perform an individual blood pressure measurement.
1. Press . All the LCD symbols will appear. Then the cu will
begin to inate automatically.
2. The heart symbol “ ” will ash when a pulse is detected
during the ination. After the measurement, the monitor
displays the systolic pressure, diastolic pressure and pulse rate.
3. Press to turn the device o.
Note:
• If the device is idle for 3 minutes, it will turn o automatically.
B. Average Measurement
Automatically performs three (3) consecutive blood pressure
measurements and displays the average result in the end.
1. Press . The device will turn on and enter the averaging
mode. Then the cu will begin to inate automatically.
2. After the rst 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 dierence between the rst and second systolic pressure

EN-6
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 to turn the device o.
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 cu (the Korotko 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 cu around the upper arm and hold in place with Velcro.
2. Press and hold until “ ” symbol appears on the display
with a beep. Release the button. Then cu begins to inate
automatically.
3. After reaching the cu pressure, the deation begins. You can
adjust the ination pressure by keep pressing to inate
if necessary. If you release , the ination will stop and
deation begins.
4. The systolic pressure is measured when the operator rst 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 o the device, press and hold or it will
switch o automatically after idle for 3 minutes.

EN-7
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 o.
For P30 Plus
To review all test results, do the following:
1. Press and release . The “ ” icon appears on the screen and
the rst reading you see is the last blood pressure result along
with date and time.
2. Press repeatedly to review other test results stored in the
device.
To review the day-average test results, do the following:
1. Press and hold for 3 seconds until the“ ” icon
appears on the screen.
2. Press and the Day average result appears on the display.
3. Press again to review the Day-time average result.
4. Press again to review the Night-time average result.

EN-8
For P30 Plus and P30 Plus BT
Press 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 to exit the memory mode or leave it without any action for
3 minutes. The device will turn o automatically.
• If using the device for the rst 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.
Classication 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.
Denitions and Classication 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.

EN-9
• 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 aect 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 ush with water.
• Do NOT use organic solvents to clean the device.
• Do NOT wash or iron the pressure cu.
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.

EN-10
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
Ination or
pressure error. Please contact local customer
service for help.
Deation error.
Blood Pressure
measurement
error.
Ret cu 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 cu inates again
while measuring.
Cu is not fastened. Fasten the cu
again.
If user’s blood pressure is higher than the
pressure the device has inated, the device
will automatically increase the pressure and
start to inate again. Stay relaxed and wait
for the measurement.

EN-11
Symbol Information
Symbol Referent
Read instructions before use
Manufacturer
Serial number
Caution, consult accompanying documents
Type BF Equipment
Temperature limitation
Collection for electrical and electronic equipment
Humidity limitation
Medical Divice
Authorised representative in the European Union
Specications
System performance
Power Source Four 1.5V AA alkaline batteries
Dimensions (w/o cu) 150 (L) x 100 mm (W) x 70.5 mm
(H)
Weight (w/o cu) 400g with batteries
Cu Size 24-43 cm (9.4 - 16.9 inches) with
air tube 100 cm
Memory Maximum 200 memory records
(P30 Plus BT); 60 (P30 Plus)
Power Saving Automatic power o if system is
idle for 3 minutes
System Operating Conditions 10°C to 40°C (50°F to 104°F), below
85% RH
Device Storage/Transport
Conditions
-20°C to 60°C (-4°F to 140°F), below
95% RH
Power Supply Input DC +6V / 1A (max) via Power Plug
Blood pressure measurement performance
Measurement unit mmHg
Systolic Measurement Range 50 mmHg -255 mmHg
Diastolic Measurement Range 25 mmHg -195 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
This device has been tested to meet the electrical and safety
requirements of: IEC/EN 60601-1, IEC/EN 60601-1-2.
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

EN-12
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 cu, 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 modied, altered, or
misused. The cu is covered by a one (1) year limited warranty.
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 the 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
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 aect 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

EN-13
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 √P80MHz to 800 MHz
d = 2,3 √P800MHz to 2,7 GHz
Where Pis 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
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 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30
cycles
Voltage
interruptions:
0 % UT; 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.

EN-14
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.