Lanaform WBPM-100 User manual

TENSIOMÈTRE
POIGNET
BLOEDDRUKMETER
POLS
BLUTDRUCKMESSGERÄT
FÜR DAS HANDGELENK
ZAPESTNI MERILNIK
KRVNEGA TLAKA
BLODTRYCKSMÄTARE
FÖR HANDLED
WHO R ISK
INDICATOR
MEDICAL
DEVICE
IRREGULAR HE ART
RHYTHM ALERT
4×30
MEMORIES
WBPM-100
WRIST BLOOD
PRESSURE
MONITOR
HEALTH

EN FR NL DE SL SV
EN Instruction manual
The photographs and other images of the
product in this manual and on the packaging
are as accurate as possible, but do not claim
to be a perfect reproduction of the product.
Thank you for choosing the LANAFORM WBPM-100
wrist blood pressure monitor. The wrist blood
pressure monitor is designed to be a non-inva-
sive measuring process and for monitoring adults’
blood pressure. It allows you to measure your blood
pressure quickly and easily, register the values and
display changes in values. It warns you if you have
an irregular heart beat.
TITLE AND DESCRIPTION OF DISPLAY
SYMBOLS ONTHEINSERT DESCRIBING
THE PRODUCT’S FEATURES
Denition of
the symbol Identication Information provided by the manufacturer
Manufacturer ’s
details Manufacturer
Batch number Production batch number
BF device The cu is type BF
applied part
Instructions
for use Followthe instructions for use
The sign background
colour: blue. The sign
graphical symbol: white
Please note:
see instructions
for use Please note: consult the
enclosed documents.
Please read these
instructions before
using the device.
Please also follow these
instructions carefully
when using the device.
Notiedbody
European
representative European representative
Electrical and
electronic
waste (WEEE)
The device should not be
disposed of with other
household waste at the
end of its serviceable life.
Dateofmanufacture
Serial Number
IP22 The rst charac teristic
numeral symbol for
“Degrees of protection
against access to haz-
ardous parts and against
solid foreign objects “.The
second characteristic
numeral symbol for
“Degrees of protection
against ingress of water”
PLEASE READ ALL THE
INSTRUCTIONS BEFORE USING
YOUR BLOOD-PRESSURE MONITOR,
PARTICULARLY THESE FEW
BASIC SAFETY INSTRUCTIONS
• When using this product, please make sure you
comply with all the items listed below. Any de-
viation from these instructions may cause injury
oraect the accuracy of the readings.
• Always measure your bloodpressure at the same
time of day so that the values are comparable.
• Rest for about 5 minutes before taking any meas-
urements.
• When you have to take several measurements
on an individual, wait for 5 minutes between
eachmeasurement.
• Do not eat, drink, smoke or take part in physical
activitiesfor atleast 30minutesbeforehand.
• Refrainfromtalkingwhenthemonitorisrecording
measurementsinordertoguaranteetheiraccuracy.
• Take another measurement if you are at all in
doubtabout thevaluesyouhavebeenmeasuring.
• Themeasurementsyou havetakenare purelyfor
informationpurposes–theyare not a substitute
for aproper medical examination!
• Notifyyourdoctorof yourresultssinceyoushould
neverunderanycircumstancestakeany medical
decisionsbasedonthesemeasurementsalone(for
example,choosing medicinesandtheirdosages).
• Donotusetheblood-pressuremonitoronnew-borns,
pregnant womenand patients with pre-eclampsia.
• Itisinappropriatefor people with serious arrhyth-
mia to use this Electronic Sphygmomanometer.
• Donot usethe cuotherthan suppliedbytheman-
ufacturer,otherwiseitmaybring biocompatible
hazard andmightresultinmeasurementerror.
• If the bloodcirculation is restricted in an armdue
to chronic or severe vascular diseases (including
vasoconstriction),the accuracy ofthe measuring
process on the wristislimited. In thiscase,use an
upperarmbloodpressuremonitor.
• Cardio-vascular disease can cause incorrect or
inaccuratemeasurements. This isalsotruefor very
lowbloodpressure,diabetes,circulationproblems,
irregular heartbeats and chills,feverorshaking.

EN FR NL DE SL SV
WBPM-100 EN Instruction manual 3/74
• The monitor must not beused at thesametime as
anyhigh-frequencysurgical device.
• Only use the device on people whose wrist pe-
rimeter is the same as that stated for the device.
• Pleasenotethatthefunctionofthelimbconcerned
maybehamperedwheninating.
• Blood circulation must not be blocked for longer
than necessary when taking blood pressure. If the
device doesnot work, remove the cufromthearm.
• Do not take measurements too frequently and
avoid sustained pressure in the cu. This causes
blood circulation tobereducedandmaycause injury.
• Please do notputthe cuonanarm,the arteries or
veinsofwhichareundergoingmedicaltreatment,
e.g.whereanintravascularaccessdeviceispresent
whichis intendedforintra-vasculartreatmentorif
there is an arteriovenous shunt in place.
• Donot usethe cuonpeople whohaveundergone
a mastectomy.
• Do not put the cu over wounds as its use may
aggravatethem.
• Put the cu only round the wrist. Do not put the
cu over other parts of the body.
• Theblood-pressuremonitorisbattery-operatedonly.
• Automaticswitch-o meansthatthe monitorwill
gointoenergy-savingmodewhenleftuntouched
for one minute.
• Thedeviceisdesignedforuseasdescribedin these
instructionsfor use.The manufacturer cannot be
held responsible for damage caused by inappro-
priate or improper use.
• Do not usethe cuotherthan suppliedbytheman-
ufacturer, otherwise it may bring biocompatible
hazard andmightresultinmeasurementerror.
• Please do not share the cu with other infective
person to avoidcross-infection.
• Avoidcompressionorrestrictionoftheconnection
tubing during measurement, which may cause
ination error, or harmful injury due to contin-
uouscupressure.
• This Electronic Sphygmomanometer is designed
for adults and should never be used on infants
or young children. Consult your physician or
other health care professionals before use on
olderchildren.
Storage and
maintenance instructions
• The monitor is made up of precision electronic
components. The accuracy of the values meas-
ured and theserviceable life of the device depend
on careful handling:
· Protect the device from shocks, humidity,
dirt, marked uctuations in temperature and
direct sunlight.
· Do not drop the device.
· Do not use the device in the vicinity of strong
electro-magnetic elds and keep it away from
cordless or portable telephone facilities, etc.
• It is recommended that the batteries be re-
moved when the device is not being used for
long periods.
Notes on batteries
• If the liquid of thebatterycell comesinto contact
with the skin or eyes,rinse the area aected with
water and consult a doctor.
Ingestion hazard! Young children might
swallow the batteries and suocate. So keep
the batteries out of the reach of children!
• Check the plus (+)etminus (-)polarity symbols.
• If a battery has leaked, put on protective
gloves and clean the battery compartment
with a dry cloth.
• Protect the batteries from excessive heat.
Explosion hazard! Do not throw
batteries onto the re.
• Do not attempt to re-charge the batteries.
• Remove the batteries from the battery com-
partment if the device is not to be used for a
lengthy period.
• Use only identical or equivalent batteries.
• Always replace allthe batteries atthe same time.
• Do not use rechargeable batteries.
• Do not dismantle, open or break the batteries.

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4/74 WBPM-100 EN Instruction manual
Instructions for repairandremoval
• Batteries must not be disposed of with house-
hold waste.
• Please take atbatteries to thecollection points
providedforthispurpose.
• Do not open the device. Failure to follow these
instructions may void the warranty.
• Youmustnot repair or adjust thedevice yourself.
If you have done so, safe operation ofthe device
can no longer be guaranteed.
• Only the customer service department or an
authorised operator may carry out any repairs.
• Before ling any claim, however, please check
thebatterystatusbeforehand andreplacethem,
ifnecessary.
• In the interests of environmental protection,
the device should not be disposed of with other
household waste at the end of its serviceable
life. It should be disposed of via your country’s
authorised collection points. The device must
be disposedof in accordance with theEuropean
WEEE (Waste Electrical and Electronic equip-
ment)Directive onusedelectrical andelectronic
devices. If youhave anyquestionsonthis, please
contact the local bodies responsible for the dis-
posal and recycling of these products.
DESCRIPTION OF THE DEVICE
1 Screen
2 STOP/START button
3 Memory button
4 Wristcu
5 Battery compartment
6 Scale for ranking measuring results
DISPLAYSCREEN
7 Systolicpressure
8 Diastolic pressure
9 Pulse rate measurement
10 Pulse symbol
11 User memory
12 Backup location number/average memory
value (AL), morning (A), evening (P)
13 Memory function symbol
14 Irregular heart beat symbol
15 Ranking measuring results
16 Deation
17 Time et date
18 Battery change symbol
INSERTING THE BATTERIES
• Remove the battery compartment cover (5) on
the left-hand side of the device.
• Insert two 1.5V micro batteries (LR03 alkaline
not included in the packaging).
• You must insert the batteries according to the
polarity illustrated. Do not use rechargeable
batteries.
• Close the battery compartment cover carefully.
• If the battery change symbol (18) appears, no
measurements can be taken and you need to
change all the batteries.

EN FR NL DE SL SV
WBPM-100 EN Instruction manual 5/74
Removing the batteries
• Flat and fully discharged batteries must be dis-
posed of in special containers or at collection
points intended for this purpose or returned
to an electrical appliance retailer. You have a
legalobligationtodisposeof batteries properly.
SET-UP DATE AND TIME
• This menu allows you to adjust the following
functions one after the other:
Time Date Hour format
You must adjust the date and time.
Without these adjustments, it is impossible
to register and read your measurements
accurately with the date and time.
Time format
• Press and hold down the STOP/
START button (2) and the memory
button (3) at the same time for 3
seconds or insert the batteries.
• Using the memory button (3) , select the time
format you require and conrm by pressing the
STOP/START button (2).
Date
• The year ashesonthe screen.Using
the memory button (3), select the
year you require and conrm by
pressing the STOP/START button (2) .
• The month ashes on the screen. Using the
memory button (3) , select the month you re-
quire and conrm by pressing the STOP/START
button (2).
• The dayashes on the screen. Using the memory
button (3) ,select the dayyou require andconrm
by pressing the STOP/START button (2).
If the time format has been adjusted
to 12 pm, the order of the day and
month displayed is reversed.
Time
• Thetimeashesonthe screen.Usingthememory
button (3), select the time you require and con-
rm by pressing the STOP/START button (2).
• The minutes ash on the screen. Using the
memory button (3), select the minutes you
requireandconrm bypressingSTOP/START(2).
• Onceall thedateshave been adjusted, thedevice
automatically switches o.
MEASURING BLOOD PRESSURE
Positioning the cu
• Blood pressure may be dierent be-
tween the right and left arm and the
blood pressure values may therefore
alsobe dierent.Always take themeas-
urement on the same arm.
• If the values between the two arms are very dif-
ferent, you mustdecidewithyourdoctor which
arm to use for the measuring process.
• Make sure your left wristisbare. Makesure that
yourblood circulationis not restrictedbyclothes
that are too tight or anything else. Put the cu
on the inside your wrist.
• Close the cu with the Velcro fastening so that
the upper edge of the device is approximately 1
2cm from the palm of your hand.
• The cu must be wrapped tightly around the
wrist without strangling it.

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6/74 WBPM-100 EN Instruction manual
Adjusting to
the correct position
• Rest for about 5 minutes before
takinganymeasurements.Other-
wise, this may cause errors.
• Measurements must only be
taken whensitting down or prone.
Make yourself comfortable before taking your
blood pressure. Make sure that your back and
your arms are well supported on the backrest
and armrests. Do not cross your legs. Put your
feet at on the oor. You must support your
arm and fold it.Make sure inevery case that the
cu is at heart level. Otherwise, this may cause
substantial errors. Relax your arm and palms.
• In order not to distort the result, it is important
to remain calm when taking the measurements
and not to talk.
Measuring blood pressure
• Position the cuasdescribed above and get into
thepositionyou wanttotakethemeasurements.
• To start the monitor, press the STOP/START
button (2). All displays will light up briey.
• Tochoose the memory location you want, press
thememoryfunctionbutton (3) .( , ,or ).
• The results of measuring 4 dierent people
or the morning and evening measurements
may be recorded separately in four memories
with 30 places.
• The monitor automatically starts the measur-
ingprocess.
• Youcan stopthe measuring process atany timeby
pressing the STOP/START button (2). As soon as it
recognises a pulse,the Pulsesymbol is displayed.
• The results of measuring the systolic pressure
(7) , diastolic pressure (8) and the pulse (9) are
displayed. The irregular heartbeat symbol (if
there is one) (14) and the symbol for ranking
the measuring results (15) ash.
• Er_ is displayed when the measuring pro-
cess has not been carried out correctly. Read
the chapter Error message/Rectifying errors
in these instructions for use and start taking
measurements again.
• Switch o the monitor by pressing the STOP/
START button (2). The measuring result is then
recorded in the user memory you have chosen.
• If you forget to switch o thedevice, it will switch
oautomaticallyafterapproximately1 minute.
• Wait at least 5 minutes before taking another
measurement.
EVALUATING THE RESULTS
Irregular heart beat
• Thisdevice isable toidentify any irregular heart
beatduringthe measuring process and displays
it, ifnecessary, after the measuring processwith
the corresponding symbol (14).
• This may indicate arrhythmia. Arrhythmia is
a disease characterised by an anomaly in the
heart rate due to disturbances in the bio-elec-
trical system. The symptoms (heart beats that
are late or early, faster or slower pulse) can be
caused particularly by heart disease, by age, by
natural predisposition, by a diet that is too rich,
by stress or even by lack of sleep. Only a medical
consultation can determine arrhythmia.
If the symbol is displayed after the measuring
process, start again. Make sure that you rest

EN FR NL DE SL SV
WBPM-100 EN Instruction manual 7/74
for 5 minutes and do not talk or move during
the measuring process. If the symbol often ap-
pears, please consult a doctor. Self-diagnosis
and self-medication based on the results of the
measuringprocess can be dangerous. You must
follow your doctor’s instructions.
Ranking measuring results
• The results of themeasurementprocess are ranked
and evaluated according to the table below.
These values must only be used for information
purposes because blood pressure diers from
person to person anddepending ontheirage, etc.
It is important to consult your doctor regularly.
Your doctor willprovideyou with yourown values
for normal bloodpressure and the levelatwhich
blood pressure is regarded as dangerous.
The ranking is displayed as is the scale of the
device for establishing the range within which
blood pressurehas been measured. If the systolic
and diastolic values are within two dierent
ranges (e.g. systolic within the “normal high”
range and diastolic within the “normal” range),
the scale markings for thechartwill always give
the highest range on the device, i.e. “normal
high” in this example.
Range of blood
pressure values Systolic (in mmHg) Diastolic (in mmHg) Colour displayed
Level 3:
acute hypertension ≥ 180 ≥ 110 Red
Level 2:
intermediate
hypertension
160 – 179 100 - 109 Orange
Level 1:
mild hypertension 140-159 90 - 99 Yellow
Normal high 130 - 139 85 - 89 Green
Normal 120 - 129 80 - 84 Green
Optimum <120 <80 Green
Source: WHO, 1999 (World Health Organisation)
Recovering and removing
measuring values
• The result of every successful measurement is
recorded with the date and time. When there
are more than 30 measuring data, the oldest
measurement is deleted.
• Press the memory button (3) todisplay the meas-
uringresult.The numberofresultsrecordedfor
the selected user is displayed.
• Press the STOP/START button (2) to select an-
other user and conrm by pressing the memory
button (3).
• The average value (AL) (12) ofallthevaluesmeas -
ured and recorded forthisuseristhendisplayed.
• If there is no result in the memory of theselected
user, the LCD screen displays “0” for blood pres-
sure and for the pulse measurement.

EN FR NL DE SL SV
8/74 WBPM-100 EN Instruction manual
• Press the memory button (3). A7 ashes on the
screen. The average value of morning measure-
ments of the last 7 days is displayed (morning:
5 am – 9 am).
• Press the memory button (3). P7 ashes on the
screen. The average value of evening measure-
ments of the last 7 days is displayed (evening:
6 pm 8 pm).
• If you press the memory button (3) again, the
latest measurement is displayed on the screen.
The irregular heartbeat symbol (if there is one)
(14) and the symbol for ranking the measuring
results (15) ash.
• If you press the memorybutton (3) again,you can
see your individual measurements.
• To switch the device o, press the STOP/START
button (2).
• You can leave the menu at any time by pressing
the STOP/START button (2).
Deleting the values measured
• To delete the records of a specic user memory,
rst select a user memory.
• Hold the memory button (3) down for 3 seconds
to delete the results.
ERROR MESSAGE/
RECTIFYING ERRORS
Problem Cause Solution
The LCD screen
displays an
abnormal result.
The cu is in the
wrongposition
or has not been
tightened suciently.
Apply the cu cor-
rectly and try again.
The body’s posture
is not correct
during the test
Re-read sec tions
“Adjusting to the
correct position” in
the instructions
and try again.
Arm or body move-
ment, nervousness,
excitement or the act
of talking during the
measuring process
Take another meas-
urement and follow
the positioning
instructions and
instructions for use.
Hear t rate is irregular
(arrhythmia) The blood pressure monitor is not
suitable for people
suering from
serious arrhythmia
• In the event of error, an error message is dis -
played on the screen Er_.
• Error messages may be displayed when:
· the systolic or diastolic pressure has not been
measured (ER1orER2 is displayed on the screen);
· systolic or diastolic pressure is outside the
measuring range (“Hi” or “Lo” is displayed on
the screen);
· the cu is too tight or too loose (ER3 or ER4 is
displayed on the screen);
· blood pressure is higherthan 300 mmHg (ER5 is
displayed on the screen);
· ination takes more than 180 seconds (ER6 is
displayed on the screen);
· there is an error on the system or the device
(ER7 or ER8 or ERA is displayed on the screen);
· the batteries are nearly at (18).

EN FR NL DE SL SV
WBPM-100 EN Instruction manual 9/74
Technical alarm – Description
If the (systolic or diastolic) blood pressure taken
is outside the range indicated in the “Technical
Features” paragraph, the technical alarm displays
the message “Hi” or “Lo” on the screen. In this case,
consult a doctor or check that you are using the
deviceproperly.Thetechnicalalarm’slimitvaluesare
values set by thefactory and can neither be changed
nor deactivated.Underthe IEC 60601-1-8,these limit
values ofthe alarm have alowerpriority.The techni-
cal alarm is not a locked alarm and does not needto
be reset. The signal displayed onthe screen switches
o automatically after approximately 8 seconds.
MAINTENANCE AND STORAGE
• Clean the device and the cu carefully, using
only a slightly damp cloth.
• Do not use detergent or solvent.
• Never put either the device or the cu in water
as this might seep into the device or cu and
damage them.
• Do not put heavy objects on the device or on
the cu when they are being stored. Remove
the batteries.
• No componentcan bemaintained by user in the
monitor.The circuit diagrams, component part
lists, descriptions, calibration instructions, or
other information which will assist the user’s
appropriately qualied technical personnel to
repair those parts of equipment which are des-
ignated repairably can be supplied.
• It is recommended the performance should be
checked every 2 years or after repair. Please
contact the service center.
• The monitor can maintainthe safety and perfor-
mancecharacteristics for aminimumof10,000
measurements or three years.
• The cu integrity is maintained after 1,000
open–closecyclesoftheclosure.
• It is recommended the cu shouldbe disinfected
2 times every week if needed (For example, in
hospitalorin clinique).Wipetheinner side(the
side contacts skin) of the cu by a soft cloth
squeezed after moistened with Ethyl alcohol
(75-90%), then dry the cu by airing.
• Clean thecu after theusage of every 200times
is recommended.
TECHNICAL SPECIFICATIONS
OF THE PRODUCT
Model number LA090205
Measuring
method Measuring blood pressure on the wrist, oscillometric and non-invasive
Measuring
range Pressure in the cu 0 – 300 mmHg Systolic pressure 60 – 260 mmHg
Diastolic pressure 40 – 199 mmHg
Pulse 40 – 180 beats/minute
Accurac y of
the indicator systolic ±3 mmHg diastolic ±3 mmHg
pulse ±5% of the value displayed
Memory 4 x 30 memory locations
Dimensions +/- 89 x 60 x 31 mm
Weight +/- 97g (without any batteries)
Cu size 14 - 19.5cm
Admin. operat-
ing conditions + 10°C a + 40°C, ≤85% relative air humidity (non-condensing)
Permissible
storage
conditions
-20°C a +50°C, ≤85% relative air humidity,
800 – 1 050 hPa of ambient pressure
Power supply 2 x 1.5 V AAA batteries
Battery lifespan Approximately 200 measurements,
depending on the increased blood
pressure and ination pressure
Accessories Instructions for use, storage box
Ranking Internal power supply, IP22, no AP or
APG, continuous use, BF device
Pressure meas-
uring system
components
Pump,Valve, LCD, Cu, Sensor
Changes could be made to the technical features
without any prior warning for updating purposes.
• This device complies with European standard
EN60601-1-2 and meets the special safety re-
quirementsconcerningelectromagneticcompat-
ibility. Please note that HF portable and mobile
communication devices are likely to aect this
device.For further details,please contact theaf-
ter-sales service at theaddress stated or consult
the end of the instructions for use.

EN FR NL DE SL SV
10 /74 WBPM-100 EN Instruction manual
• This device complies with European Directive
93/42/EEC for Medical Products, the Medical
Products Act as well as European Standards
EN1060-1 (pertaining to Non Invasive Blood
Pressure Monitoring Equipment, part 1: Gen-
eral Requirements), EN 1060-3 (pertaining to
Non Invasive Blood Pressure Monitoring Equip-
ment,part3:Supplementary Requirements for
Electromechanical Blood Pressure Monitoring
Equipment) and EC80601-2-30 (Electrical
Medical Equipment, parts 2-30: Particular re-
quirements for the safety, including essential
performance, of automatic non-invasive blood
pressure monitoring equipment).
• The accuracy of this blood pressure monitor has
been testedcorrectly and itsdurability has been
designed for long-term use. Technical meas-
urement checks must be carried out using the
appropriatemethods whenthe device is used for
medical purposes. For accurate information on
how to check the accuracy ofthe device, you can
send arequest by post tothe after-sales service.
ADVICE REGARDING
THE DISPOSAL OF WASTE
All the packaging is composed of materials that
pose no hazard for the environment and which can
be disposed of at your local sorting centre to be
used as secondary raw materials. The cardboard
may be disposed of in a paper recycling bin. The
packaging lm must be taken to your local sorting
and recycling centre.
When you have nished using the device, please
disposeofit inanenvironmentallyfriendlywayand
in accordance with thelaw.Prior to disposal, please
remove the battery and dispose of it at a collection
point so that it can be recycled.
Under no circumstances should
spent batteries be disposed of
with household waste.
EC 0197 DECLARATION DE CONFORMITY
Medical device
Category IIa.
We, LANAFORM,
hereby declare that the medical device
“WBPM-100” Lot001 LA090205 complies with
European Directive 93/42/EC concerning medical
devices and its most recent amendment 2007/47/EC.
LIMITED WARRANTY
LANAFORM guarantees this product against any
material or manufacturing defect for a period of
two years from the date of purchase, except in the
circumstances described below.
The LANAFORM guarantee does not cover damage
caused as aresult ofnormal wear to this product. In
addition, the guarantee covering this LANAFORM
product does not cover damage caused by abusive
or inappropriate orincorrect use, accidents, the use
of unauthorized accessories, changes made to the
productorany othercircumstance,ofwhateversort,
that is outside LANAFORM’s control.
LANAFORM may not be held liable for any type of
circumstantial, indirect or specic damage.
All implicit guarantees relating to the suitability of
the product are limited to a period of two years from
the initial date of purchase as long as a copy of the
proof of purchase can be supplied.
On receipt, LANAFORM will repair or replace your
appliance at its discretion and will return it to you.
The guarantee is only valid through LANAFORM’s
ServiceCentre.Anyattempttomaintainthisproduct
by a person other than LANAFORM’s Ser vice Centre
will render this guarantee void. •