FOR-A TD-3124B User manual

BLOOD PRESSURE MONITORING SYSTEM
BLUTDRUCKÜBERWACHUNGSSYSTEM
DE SURVEILLANCE DE LA TENSION ARTÉRIELLE
SISTEMA DI CONTROLLO DELLA PRESSIONE DEL SANGUE
SISTEMA DE MONITORIZAÇÃO DA PRESSÃO ARTERIAL
ΣΥΣΤΗΜΑ ΠΑΡΑΚΟΛΟΥΘΗΣΗΣ ΑΡΤΗΡΙΑΚΗΣ ΠΙΕΣΗΣ
Owner’s Manual
Bedienungsanleitung
Manuel de l’utilisateur
Manuale dell’utente
Manual de instruções
Εγχειρίδιο χρήση
Designed & Authorized by
ForaCare Suisse AG
CH-9000 St. Gallen, Switzerland
www.foracare.ch
TaiDoc Technology Corporation
B1-7F., No. 127, Wugong 2nd Road,
Wugu Dist., 24888 New Taipei City,
Taiwan
www.taidoc.com
MedNet EC-REP GmbH

Germany
ver 1.0 2021/07 311-3124200-019
TD-3124B
For self-testing / Zur Selbstmessung /
Pour l’automesure / Per l’automisurazione / Para


Contents
IMPORTANTSAFETYPRECAUTIONS 02
BEFORE YOU BEGIN 03
Intended Use 03
Test Principle 03
Meter Overview 03
Display Screen 04
TESTINGYOUR BLOOD PRESSURE 04
Before Measurement 04
Fitting the Cu Properly 04
Proper Measurement Position 05
TAKING MEASUREMENTS 05
MONITOR MEMORY 06
Reviewing Test Results 06
MAINTENANCE 06
Battery 06
Low Battery Signal 06
Replacing the Battery 06
Using AC Adapter 07
Caring for your Meter 08
DETAILED INFORMATION 08
Reference Values 08
SYSTEM TROUBLESHOOTING 09
Error Messages 09
Troubleshooting 09
SYMBOL INFORMATION 10
SPECIFICATIONS 10
System performance 10
Blood pressure measurement performance 11
TERMS & CONDITIONS OFWARRANTY 11
APPENDIX 12

EN-2
Dear System Owner:
Thank you for purchasing the FORA Vital Blood Pressure
Monitoring System. This manual provides important information
to help you operate this system properly. Before using this
product, please read the following contents thoroughly and
carefully.
With the compact size and easy operation of this FORA Vital
Blood Pressure Monitoring System, you can easily monitor your
blood pressure by yourself at any time or place. In addition,
this system can help you and your healthcare professionals to
monitor and adjust your treatment plans, and keep your blood
pressure under control.
If you have other questions regarding this product, please
contact the place of purchase.
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1.Use this device ONLY for the intended use described in this
manual.
2.Do NOT use accessories which are not specied by the
manufacturer.
3.Do NOT use the device if it is not working properly or
damaged.
4.Do NOT use under any circumstances on newborns or
infants.
5.This device does NOT serve as a cure for any symptoms or
diseases. The data measured are for reference only. Always
consult your doctor to have the results interpreted.
6.Keep the equipment and its exible cord away from hot
surfaces.
7.Do NOT apply the cu to areas other than the place
directed.
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.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

EN-3
Meter Overview
2
1
3
5
4
6
7
8
1. Display Screen
2. ON/OFF Button
To start a single NIBP measurement (NIBP: Non-invasive
blood pressure)
3. Air jack
4. DC Adapter Port
Connect to a power supply
5. M Button
Enter the meter memory
6. Pressure Cu
7. Air Tube
8. Air Plug
Connect to air jack
BEFORE YOU BEGIN
Intended Use
The FORA Vital system is a system designed to measure blood
pressure non-invasively. It is intended for use at home and in
clinical settings. The device is not to be used for the diagnosis
or screening of hypertension or for testing on newborns.
Test Principle
Blood pressure is measured non-invasively at the arm based
on oscillometric method.
This device is NOT able to take measurements in the
presence of common arrhythmia, such as atrial or ventricular
premature beats or atrial brillation. It may produce reading
error.

EN-4
• Take a 5-10 minute break between measurements. This
break can be longer if necessary, depending on your
physical condition.
• Keep the records for your doctor as reference.
• Blood pressure naturally varies between each arm. Always
measure your blood pressure on the same arm.
Fitting the Cu Properly
1. Connect the air plug of the tubing to
the air jack of the meter.
Pile Side Material
Sewn Hook Material
D-Ring
2. Assemble the cu as shown on the
right. The smooth surface should be
inside of the cu loop and the metal
D-ring should not touch your skin.
Main Arteries
2~3cm
3. Stretch your left (right) arm in front
of you with your palm facing up. Slide
and place the cu onto your arm to let
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 2 cm to
3 cm (0.8”to 1.2”) above your elbow.
Align the tube over the main arteries
on the inside.
Display Screen
1
4
5
2
3
1. Test Result
2. Memory Mode Symbol
3. Low Battery Symbol
4. Pulse Rate Symbol
5. Pulse Rate
TESTING YOUR BLOOD PRESSURE
Before Measurement
• 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.

EN-5
4. Measurement is in progress.
After the meter is turned on, the cu will begin to inate
automatically.
TAKING MEASUREMENTS
Always apply the pressure cu before turning on the
meter.
1.Press .All the LCD symbols and the
last blood pressure result will appear.
Then the cu will begin to inate
automatically.
2.The heart symbol “ ”will ash when
pulse is detected during the ination.
3.After the measurement, the meter
displays the systolic pressure, diastolic
pressure and pulse rate.
4.Press to switch o. Or it will switch
o automatically after being idle for 3
minutes.
WARNING:
• If you press during measurement, the monitor will be
turned o.
INDEX
RED LINESHOULD BE AT THE INSID
INDEX MUST
The range index of cuff should
fall within this range
4. Leave a little free space between
the arm and the cu; you should
be able to t two ngers between
them. Clothing must not restrict the
arm. Remove all clothing covering or
constricting the measurement arm.
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. Press . Remain still
and do not talk or move during the
measurement.
WARNING:
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.

EN-6
• If the pulse rate symbol is shown as“ ”instead of
“ ”, this indicates that the meter has detected an irregular
heartbeat.
MONITOR MEMORY
Your meter stores the 100 most recent blood pressure test
results in the meter memory. To recall the memory, start with
the meter o.
Reviewing Test Results
1.Press and release .
will appear on the display. Press again, and the rst
reading you see is the last test result.
2.Press to recall the next test results stored in the meter
each time you press.
3.Exit the memory.
Keep pressing and the meter will turn o.
NOTE:
• To delete ALL the results, press and rmly holds for 4
seconds until“dEL”displays.
• Releases , “CLr ALL” and“ “ are displayed on the meter,
which indicates that all results have been deleted.
• Any time you wish to exit the memory, presss or leave it
without any action for 3 minutes. The meter will switch o
automatically.
• If using the meter for the rst time, you will only see the
“ “ symbol on the display when you recall the test results.
It indicates that there is no test result in the memory.
MAINTENANCE
Battery
Your meter comes with four (4) 1.5V AA size alkaline batteries.
Low Battery Signal
The symbol appears with E-b:
The power is not enough to do a
test. You must change the batteries
immediately.
Replacing the Battery
To replace the batteries, make sure the meter is turned o.

EN-7
1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old batteries and replace with four 1.5V AA
size alkaline batteries.
3. Close the battery cover. If the batteries are inserted
correctly, you will hear a“beep” afterwards.
NOTE:
• Replacing the batteries does not aect the test results
stored in memory.
• As with all small batteries, these batteries should be kept
away from small children. If swallowed, promptly seek
medical assistance.
• Batteries might leak chemicals if unused for a long time.
Remove the batteries if you are not going to use the device
for an extended period (i.e., 3 months or more).
• Properly dispose of the batteries according to your local
environmental regulations.
USING AC ADAPTER
Connect AC Adapter to the Meter
1.Connect the AC adapter plug to the
DC adapter jack of the meter.
2.Plug the AC adapter power plug into
an electrical outlet.
Press ON/OFF to start the
measurement.
Remove the AC Adapter from the Meter
1. When the meter is o, remove
AC adapter power plug from the
electrical outlet.
2. Disconnect the AC adapter plug from
the DC adapter jack of the monitor.

EN-8
CARING FOR YOUR METER
To avoid the meter from dirt, dust or other contaminants,
wash and dry your hands thoroughly before use.
Cleaning
1. To clean the meter exterior, wipe it with a cloth moistened
with tap water or a mild cleaning agent, and then dry the
device with a soft dry cloth. Do NOT ush with water.
2. Do NOT use organic solvents to clean the meter.
3. Do NOT wash the pressure cu.
4. Do NOT iron the pressure cu.
Meter Storage
• Storage condition: -20°C to 70°C (-4°F to 158°F), between
10% to 95% relative humidity.
• Always store or transport the meter in its original storage
case.
• Avoid dropping or heavy impact.
• Avoid direct sunlight and high humidity.
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*4.
Monitoring your routine blood pressure trend helps you to
know your body condition. Human blood pressure naturally
increases after reaching middle age.
The recommended blood pressure range is as below:
Classication Systolic Pressure (mmHg) Diastolic Pressure (mmHg)
Hypotension*2 Less than 90 Less than 60
Normal*3 Less than 120 Less than 80
Pre-hyperten-
sion*3 120 – 139 80 – 89
Stage 1 Hyper-
tension*3 140 – 159 90 – 99
Stage 2 Hyper-
tension*3 160 or more 100 or more
*2 : National Heart, Lung, and Blood Institute, Diseases and
Conditions
*3 : The Seventh Report of the Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of High
Blood Pressure. NIH Publication. 2003. No. 03-5233
*4 : American Diabetes Association: The Diabetes-Heart
Disease Link Surveying Attitudes

EN-9
Troubleshooting
1. If no display appears after pressing :
POSSIBLE CAUSE WHAT TO DO
Batteries exhausted. Replace the batteries.
Batteries incorrectly
installed or absent.
Check if the batteries are correctly
installed.
2. If the heart rate is higher/lower than user’s average:
POSSIBLE CAUSE WHAT TO DO
Movement during
measurement. Repeat the measurement.
Batteries incorrectly
installed or absent.
Rest at least 30 minutes before
repeating the measurement.
3. If the result is higher/lower than the user’s average
measurement:
POSSIBLE CAUSE WHAT TO DO
User may not be in the
correct position while
measuring.
Adjust to the correct position for
measurement.
Blood pressure naturally
varies from time to time.
Keep in mind for the next
measurement.
SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem
persists, or error messages other than the ones below appear,
please call your local customer service. Do not attempt to
repair by yourself and never try to disassemble the monitor
under any circumstances.
Error Messages
MESSAGE CAUSE WHAT TO DO
E-1 Ination or
pressure error.
Please contact local
customer service for help.
E-4 Blood pressure
measurement error.
Ret cu tightly and
correctly.
Relax and repeat the
measurement. If error still
remains, contact local
customer service for help.
E-b Batteries are dead. Replace the batteries.
E-A
Problems with the
meter.
Review the instructions and
repeat the test. If the meter
still does not work, please
contact the local customer
service for help.
E-E

EN-10
4. If the cu inates again while measuring:
POSSIBLE CAUSE WHAT TO DO
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.
SYMBOL INFORMATION
Symbol Referent Symbol Referent
Consult instructions
for use
Storage / transport
temperature limitation
Type BF applied part CE Mark
Storage / transport
humidity limitation Manufacturer
Medical device Battery
Serial number Model No.
Authorised
representative in the
European Union
Ingress protection
rating
Dispose of or recycle
the electrical wastes
according to local
regulations
Caution, consult
accompanying
documents
SPECIFICATIONS
System performance
Power source: Four 1.5V AA alkaline batteries
Size of monitor w/o cu: 130.5 mm (L) x 90 mm (W) x 55 mm
(H), 210 g without batteries.
Cu Size: 24-43 cm (9.4-16.9 inches) with air tube 100 cm
Memory: Maximum 100 memory records
Power saving: Automatic power o if system idle for 3
minutes
System operating conditions: 5°C to 40°C (41°F to 104°F),
between 15% - 93% RH
Meter storage conditions: -25°C to 70°C (-13°F to 158°F),
between 10% - 95% RH
Power Supply Input: four (4)1.5V AA size alkaline batteries
DC +6V / 1A (max) via Power Plug

EN-11
Blood pressure measurement performance
Pressure range: 0 - 300 mmHg
Measurement unit: mmHg
Systolic Measurement Range: 60 mmHg -255 mmHg
Diastolic Measurement Range: 30 mmHg -195 mmHg
Pulse Rate Measurement Range: 40 -199 beats / minute
Maximum ination pressure: 280 mmHg
Accuracy of Pressure: ±3 mmHg or ±2% of reading
Accuracy of Pulse rate: ±4% of reading
Heart rate range: 40 - 199 beat per minute
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
TERMS & CONDITIONS OF WARRANTY
1.We warrant this product to be free of defects in
workmanship and materials within the said warranty
period on the warranty certicate.
2.During the warranty period, if this product is found to be
defective, you may bring it, together with the purchase
receipt and Warranty Certicate, on a carry-in basis to our
oce during normal business hours for warranty service.
We will then repair or replace defective parts or exchanging
the whole product as we may choose, at no charge to the
original owner. After such repair, replacement or exchange,
the product will be warranted for up to the remainder of
the warranty period.
3.This warranty is valid only if the Warranty Certicate and
Warranty Registration Card are duly completed with date
of purchase, serial number and dealer’s stamp, and if the
Warranty Registration Card is sent to our oce not later
than 14 days from the date of purchase.
4.This warranty is void if this product has been repaired or
serviced by unauthorized person.
This warranty does not cover defects caused by misuse,
abuse, accident, tampering, and lack of reasonable care, re
or any other acts beyond human control.
5.Except as stated in the above paragraphs, we disclaim
all other warranties, implied or expressed, including the
warranties of merchantability or tness for a particular
purpose with respect to the use of this product. We shall
not be liable for any direct, consequential or incidental
damages arising out of the use or inability to use this
product.

EN-12
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 Vital
The FORA Vital 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 Vital can help prevent electromagnetic interference by maintaining a
minimum distance between the portable and mobile RF communications equipment (transmitters)
and the FORA Vital 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

80 MHz to 800 MHz

800 MHz to 2,7 GHz

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 Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the FORA Vital 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 Vital 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 Vital 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 Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the FORA Vital 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 Vital
requires continued operation during
power mains interruptions, it is
recommended that the FORA Vital
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 Vital 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 Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the FORA Vital 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

equipment must not be used close to any
parts of the FORA Vital including cables, other
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:



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 Vital is used exceeds the
applicable RF compliance level above, the FORA Vital 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 Vital.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

EN-14
Manufacturer’s declaration-electromagnetic immunity

equipment
The FORA Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
Test
frequency
(MHz)
Band a)
(MHz)
Service
a) Modulation b)
Maximum
power
(W)
Distance
(m)

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 9745
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.

Inhalt
WICHTIGE SICHERHEITSHINWEISE 02
BEVOR SIE BEGINNEN 03
Verwendungszweck 03
Mess-Prinzip 03
Messgerät-Übersicht 03
Display-Anzeige 04
MESSEN IHRES BLUTDRUCKS 04
Vor der Messung 04
Richtiges Anlegen der Manschette 04
Die richtige Messposition 05
DURCHFÜHRUNG DER MESSUNG 05
MESSGERÄTESPEICHER 06
Durchsehen der Messwerte 06
WARTUNG 07
Batterien 07
Meldung für schwache Batterien 07
Austausch der Batterien 07
VERWENDEN DES NETZTEILS 08
PFLEGE IHRES MESSGERÄTS 08
DETAILLIERTE INFORMATIONEN 09
Referenzwerte 09
SYSTEM-FEHLERBEHEBUNG 09
Fehlermeldungen 09
Fehlersuche 10
HINWEISE ZU DEN SYMBOLEN 11
TECHNISCHE DATEN 11
Systemleistung 11
Blutdruck-Messleistung 11
GARANTIEBEDINGUNGEN 12
ANHANG 13

DE-2
Bedienungsanleitung:
Sehr geehrter Nutzer,
vielen Dank, dass Sie sich für das FORA Vital
Blutdrucküberwachungssystem entschieden haben. Diese
Bedienungsanleitung enthält wichtige Informationen, die Ihnen
helfen, das System richtig zu bedienen. Bevor Sie dieses Produkt
benutzen, lesen Sie bitte den folgenden Inhalt gründlich und
sorgfältig durch.
Mit der kompakten Größe und der einfachen Bedienung
des FORA Vital Blutdrucküberwachungssystems können Sie
Ihren Blutdruck jederzeit und an jedem Ort einfach selbst
überwachen. Darüber hinaus kann dieses System Ihnen und
Ihren medizinischen Betreuern helfen, Ihre Behandlungspläne
zu überwachen, anzupassen und Ihren Blutdruck unter Kontrolle
zu halten.
Wenn Sie weitere Fragen zu diesem Produkt haben, wenden Sie
sich bitte an Ihren lokalen Händler.
WICHTIGE SICHERHEITSHINWEISE
VOR BENUTZUNG LESEN
1.Verwenden Sie dieses Gerät NUR für den in dieser
Bedienungsanleitung beschriebenen Verwendungszweck.
2.Verwenden Sie KEIN Zubehör, das nicht vom Hersteller
angegeben wurde.
3.Verwenden Sie das Gerät NICHT, wenn es nicht
ordnungsgemäß funktioniert oder beschädigt ist.
4.Verwenden Sie das Gerät unter keinen Umständen bei
Neugeborenen oder Säuglingen.
5.Dieses Gerät dient NICHT zur Heilung von Krankheiten
oder Symptomen. Die gemessenen Daten dienen lediglich
als Referenz. Wenden Sie sich immer an Ihren Arzt, um die
Ergebnisse interpretieren zu lassen.
6.Halten Sie das Gerät und sein exibles Kabel von heißen
Oberächen fern.
7.Legen Sie die Manschette NICHT an anderen als der
angegebenen Stelle an.
8.Die Verwendung dieses Geräts in einer trockenen
Umgebung, insbesondere wenn synthetische Materialien
vorhanden sind (synthetische Kleidung, Teppiche usw.),
kann zu schädlichen statischen Entladungen führen, was
zu fehlerhaften Ergebnissen führen kann.
9.Verwenden Sie dieses Gerät nicht in unmittelbarer Nähe
von Quellen mit starker elektromagnetischer Strahlung, da
diese den präzisen Betrieb beeinträchtigen können.
10.Sollten Sie im Zusammenhang mit der Verwendung dieses
Produkts einen schwerwiegenden Zwischenfall feststellen,
melden Sie ihn bitte dem Hersteller sowie der zuständigen
Behörde für Medizinprodukte Ihres Landes.

DE-3
oder ventrikulären Extrasystolen oder Vorhoattern,
vorzunehmen. Es kann zu Messfehlern kommen.
Messgerät-Übersicht
2
1
3
5
4
6
7
8
1. Display-Anzeige
2. EIN / AUS-Taste
Zum Starten einer einzelnen NIBP-Messung (NIBP: Nicht-
invasiver Blutdruck)
3. Luftbuchse
4. DC-Adapteranschluss
Zum Anschluss an eine Stromversorgung
5. M-Taste
Aufrufen des Messgerätespeichers
6. Druckmanschette
7. Luftschlauch
8. Luftstecker
Anschluss an die Luftbuchse
Ein schwerwiegender Vorfall ist jeder Vorfall, der direkt
oder indirekt zu einem der folgenden Ereignisse geführt
hat oder geführt haben könnte:
(a) Tod eines Patienten, eines Anwenders oder anderer
beteiligter Personen,
(b) die vorübergehende oder dauerhafte ernsthafte
Verschlechterung des Gesundheitszustandes eines
Patienten, eines Anwenders oder einer anderen beteiligten
Person,
(c) eine ernstliche Bedrohung der öentlichen Gesundheit.
Bewahren Sie diese Anweisung an einem sicheren
Ort auf
BEVOR SIE BEGINNEN
Verwendungszweck
Das FORA Vital-System ist ein System zur nicht-invasiven
Blutdruckmessung. Es ist für die Verwendung zu Hause und
in klinischen Umgebungen vorgesehen. Das Gerät darf nicht
zur Diagnose oder zum Screening von Bluthochdruck oder
für Messungen an Neugeborenen verwendet werden.
Mess-Prinzip
Der Blutdruck wird nicht-invasiv auf Basis der
oszillometrischen Methode am Arm gemessen.
Dieses Gerät ist NICHT in der Lage, Messungen während
allgemeiner Herzrhythmusstörungen, wie atrialen

DE-4
• Messen Sie nicht, wenn Sie unruhig oder angespannt sind.
• Machen Sie zwischen zwei Messungen eine Pause von 5-10
Minuten. Je nach der körperlichen Verfassung kann diese
Pause bei Bedarf auch länger sein.
• Bewahren Sie die Aufzeichnungen für Ihren Arzt als
Referenz auf.
• Der Blutdruck variiert auf natürliche Weise zwischen
beiden Armen. Messen Sie Ihren Blutdruck immer am
gleichen Arm.
Richtiges Anlegen der Manschette
1. Schließen Sie den Luftstecker des
Schlauches an die Luftbuchse des
Messgeräts an.
Flormaterial
V
ernähtes Flauschband
D-Ring
2. Legen Sie die Manschette an
wie rechts dargestellt. Die glatte
Oberäche sollte sich innerhalb der
Manschettenschlaufe benden und
der Metall-D-Ring sollte Ihre Haut
nicht berühren.
Display-Anzeige
1
4
5
2
3
1. Messergebnis
2. Symbol für Speichermodus
3. Symbol für schwache Batterien
4. Symbol für Pulsfrequenz
5. Pulsfrequenz
MESSEN IHRES BLUTDRUCKS
Vor der Messung
• Vermeiden Sie mindestens 30 Minuten vor einer Messung
Koein, Tee, Alkohol oder Tabak.
• Warten Sie nach einem Training oder Bad 30 Minuten,
bevor Sie messen.
• Setzen oder legen Sie sich vor einer Messung mindestens
10 Minuten lang hin.