Lanaform ABPM-100 User manual

TENSIOMÈTRE
BRAS
BLOEDDRUKMETER
ARM
OBERARMBLUTDRUCK-
MESSGERÄT
NADLAKTNI MERILNIK
KRVNEGA TLAKA
BLODTRYCKSMÄTARE
FÖR ARM
WHO R ISK
INDICATOR
MEDICAL
DEVICE
IRREGULAR HE ART
RHYTHM ALERT
4×30
MEMORIES
ABPM-100
ARM 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 ABPM-100
arm blood pressure monitor. The arm blood pressure
monitor is designed to be a non-invasive 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.Itwarns youifyou havean irregularheartbeat.
TITLE AND DESCRIPTION OF DISPLAY
SYMBOLS ON THE INSERT 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.
Date of
manufacture
Serial number
Keep dry
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 devi-
ation from these instructions may cause injury or
aect the accuracy of the readings.
• Always measure your blood pressure at the same
time of day so that the values are comparable.
• Rest for about 5 minutes before taking any
measurements.
• When you have to take several measurements on
an individual, wait for 5 minutes between each
measurement.
• Do not eat, drink, smoke or take part in physical
activitiesfor at least 30 minutes beforehand.
• Refrain from talking when themonitoris recording
measurementsinordertoguaranteetheiraccuracy.
• Take another measurement if you are at all in
doubtabout thevaluesyouhavebeenmeasuring.
• The measurements you have taken are purely for
information purposes – they are not a substitute
for a proper medical examination!
• Notifyyourdoctorofyourresultssinceyoushould
never under any circumstances take any medical
decisionsbasedon thesemeasurementsalone(for
example,choosingmedicinesandtheir dosages).
• Donotusetheblood-pressure monitoronnew-borns,
pregnant womenand patients with pre-eclampsia.
• Itis inappropriate forpeoplewithserious arrhyth-
mia to use this Electronic Sphygmomanometer.
• Donot use thecu otherthansuppliedby theman-
ufacturer, otherwise it may bring biocompatible
hazard and might result in measurement error.
• If the blood circulation is restricted in an arm due
to chronic or severe vascular diseases (including
vasoconstriction), the accuracy of the measuring
process on the wrist is limited. In this case, use an
upperarmblood pressure monitor.
• Cardio-vasculardiseasecancauseincorrect or in-
accurate measurements. This is also true for very
lowbloodpressure,diabetes,circulationproblems,
irregular heartbeats and chills, feverorshaking.

EN FR NL DE SL SV
ABPM-100 EN Instruction manual 3/74
• The monitor mustnot beused at thesame time as
anyhigh-frequency surgical device.
• Onlyuse thedevice on people whosearm perimeter
is the same as that stated for the device.
• Pleasenotethatthefunctionofthelimbconcerned
maybehamperedwhen inating.
• Blood circulation must not be blocked for longer
thannecessary when takingblood pressure. If the
device does notwork, removethe cufromthe arm.
• Donottakemeasurementstoofrequentlyandavoid
sustained pressure in the cu. This causes blood
circulation to be reduced and may cause injury.
• Please donot putthe cu on an arm, thearteriesor
veinsof whichareundergoingmedicaltreatment,
e.g. whereanintravascular accessdevice is present
whichisintendedforintra-vasculartreatmentorif
there is an arteriovenous shunt in place.
• Do notuse thecu onpeoplewho haveundergone
a mastectomy.
• Do not put the cu over wounds as its use may
aggravatethem.
• Put thecuonlyround thearm.Donotput thecu
over other parts of the body.
• Theblood-pressuremonitorisbattery-operatedonly.
• Automatic switch-omeans that themonitorwill
gointoenergy-savingmodewhen leftuntouched
for one minute.
• Thedeviceisdesignedfor useasdescribedinthese
instructions for use. The manufacturer cannot be
held responsible for damage caused by inappro-
priate or improper use.
• Donot use thecu otherthansuppliedby theman-
ufacturer, otherwise it may bring biocompatible
hazard and might result in measurement error.
• Please do not share the cu with other infective
person to avoid cross-infection.
• Avoidcompressionor restrictionoftheconnection
tubing during measurement, which may cause
ination error, or harmful injury due to contin-
uouscupressure.
• ThisElectronicSphygmomanometeris designedfor
adultsand shouldneverbeusedoninfantsoryoung
children. Consult your physician or other health
careprofessionalsbefore use on older children.
Storage and
maintenance instructions
• The monitor is made up of precision electronic
components. The accuracy of the values meas-
uredand the serviceable life ofthedevice 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 theliquidof thebatterycellcomes into contact
with theskinor eyes, rinse the area aectedwith
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 (+)et minus (-) 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 all thebatteries at the same time.
• Do not use rechargeable batteries.
• Do not dismantle, open or break the batteries.

EN FR NL DE SL SV
4/74 ABPM-100 EN Instruction manual
Instructions for repair and removal
• Batteries must not be disposed of with house-
hold waste.
• Please take at batteries tothe collectionpoints
providedfor this purpose.
• Do not open the device. Failure to follow these
instructions may void the warranty.
• Youmust notrepair oradjustthe device yourself.
If you havedone so, safe operation ofthedevice
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
the battery statusbeforehand and replace them,
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 disposed of in accordance with the European
WEEE (Waste Electrical and Electronic equip-
ment)Directiveon usedelectrical andelectronic
devices. Ifyou have anyquestions on this,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 Cuconnectionsocket
5 Battery compartment
6 Scale for ranking measuring results
7 Cu
8 Cu pipe
9 Connection to the cu
DISPLAYSCREEN
10 Systolicpressure
11 Diastolic pressure
12 Pulse rate measurement
13 Pulse symbol
14 User memory
15 Backup location number/average memory
value (AL), morning (A), evening (P)
16 Memory function symbol
17 Irregular heart beat symbol
18 Ranking measuring results
19 Deation
20 Time et date
21 Battery change symbol
INSERTING THE BATTERIES
• Remove the battery compartment cover (5) on
the left-hand side of the device.
• Insert four 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.
• Closethe batterycompartment cover carefully.
• If the battery change symbol (21) appears, no
measurements can be taken and you need to
change all the batteries.

EN FR NL DE SL SV
ABPM-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
legalobligationtodisposeofbatteries 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 ashes on the screen. Using
the memory button (3) , select the
year you require and conrm by
pressing the STOP/STARTbutton (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 asheson the screen. Usingthe memory
button (3), select the day you require and con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
• The time ashes onthe screen.Using thememory
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
require andconrmby pressingSTOP/START (2) .
• Onceall the dates have been adjusted, the device
automatically switches o.
MEASURING BLOOD PRESSURE
Positioning the cu
• Put the cu on your bare left
arm. The circulation in your
arm must not be restricted
by clothes that are too tight
or anything else.
• Position the cu on your
arm so that the lower edge
is 1 - 2cm above the crook of your elbow and
above the artery. The pipe is directed towards
the middle of your palm.
• Now close the free part of the cu around your
arm using the Velcro without making it too
tight. You must be able to insert two ngers
under the cu.
• Now connect the cu’s pipe into the cu’s
power supply.
The device must only be used with the
original cu. The cu is intended for an
arm circumference of 22 to 30cm.

EN FR NL DE SL SV
6/74 ABPM-100 EN Instruction manual
Adjusting to
the correct position
• Rest for about 5 minutes before
taking any measurements. Oth-
erwise, this may cause errors.
• Measurements can only be taken when sitting
down or prone. Make sure in every case that the
cu is at heart level.
• 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.
• In order not to distort the result, it is important
to remain calm whentaking the measurements
and not to talk.
Measuring blood pressure
• Position the cu as describedabove andgetinto
thepositionyou wanttotakethemeasurements.
• Tostartthe monitor, pressthe STOP/STARTbutton
(2). All displays will light up briey.
• To choose 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 stop the measuringprocess at anytimeby
pressing the STOP/START button (2). As soon as it
recognises a pulse,the Pulsesymbolis displayed.
• The results of measuring the systolic pressure
(10) , diastolic pressure (11) and the pulse (12)
are displayed. The irregular heartbeat symbol
(if there is one) (17) and the symbol for ranking
measuring results (18) ash.
• Er_ is displayed when the measuring process
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 youforgetto switch o the device, it will switch
oautomaticallyafterapproximately1minute.
• Wait at least 5 minutes before taking another
measurement.
EVALUATING THE RESULTS
Irregular heart beat
• Thisdeviceis able toidentify anyirregularheart
beatduringthe measuring process anddisplays
it, if necessary,after the measuring processwith
the corresponding symbol (17).
• 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 ofsleep. Onlya 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
ABPM-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
measuring process can be dangerous. You must
follow your doctor’s instructions.
Ranking measuring results
• Theresultsofthemeasurementprocessareranked
and evaluated according to the table below.
These values must only be used for information
purposes because blood pressure diers from
personto person and dependingon their age, etc.
It is important to consult your doctor regularly.
Your doctor will provideyou with your own values
fornormalbloodpressureandthelevel atwhich
blood pressure is regarded as dangerous.
The ranking is displayed as is the scale of the
device for establishing the range within which
blood pressure hasbeen 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 markingsforthe chart will 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) to displaythemeas-
uringresult.Thenumberofresultsrecorded for
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) (15) ofall thevaluesmeas-
ured andrecorded for this useris then displayed.
• If there isno 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 ABPM-100 EN Instruction manual
• Press the memory button (3). A7 ashes on the
screen.Theaveragevalue ofmorningmeasure-
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 again (3)
again, the latest measurement is displayed on
the screen. The irregular heartbeat symbol (if
there is one) (17) and the symbol for ranking
the measuring results (18) ash.
• If youpress the memory button (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.
ERRORMESSAGE/RECTIFYINGERRORS
Problem Cause Solution
The LCD screen
displays an
abnormal result.
The cu is in the
wrong position or has
not been tightened
suciently.
Apply the cu cor-
rectly and tr y again.
The body’s posture
is not correct
during the test
Re-read sections
“Adjusting to the
correct position”
in the instructions
and try again.
Arm or body move-
ment, nervousness,
excitement or the ac t
of talking during the
measuring process
Take another
measurement and
followthe 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
• Intheeventof error,anerror messageis displayed
on the screen Er_.
• Error messages may be displayed when:
· the systolic or diastolic pressure has not been
measured (ER1or ER2 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 ishigherthan 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
ABPM-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 Fea-
tures” paragraph, the technical alarm displays the
message “Hi” or “Lo” on the screen. In this case,
consultadoctor or check that youare usingthe device
properly.The technical alarm’slimit valuesarevalues
set by the factory and can neither be changed nor
deactivated. Under the IEC 60601-1-8, these limit
values of the alarm have a lower priority. The tech-
nical alarmis notalocked alarm anddoesnotneedto
be reset. Thesignal displayed on the screen switches
o automatically after approximately 8 seconds.
MAINTENANCE AND STORAGE
• Clean thedevice 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 component can be maintained by user inthe
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 monitorcan maintain thesafety and perfor-
mance characteristics for a minimum of 10,000
measurements or three years.
• The cu integrity is maintained after 1,000
open–closecycles of the closure.
• It is recommended the cu should be disinfect-
ed 2 times every week if needed (For example,
in hospital or in clinique). Wipe the inner 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afterthe usage of every 200 times
is recommended.
TECHNICAL SPECIFICATIONS
OF THE PRODUCT
Model number LA090206
Measuring
method Measuring blood pressure on the arm, 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 +/- 107 x 80 x 52mm
Weight +/- 287g (without any batteries)
Cu size 22 - 30cm
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 4 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, IP20, 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 the
after-salesservice at the address stated or consult
the end of the instructions for use.

EN FR NL DE SL SV
10 /74 ABPM-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
NonInvasiveBlood Pressure Monitoring Equip-
ment, part 3: Supplementary Requirementsfor
Electromechanical Blood Pressure Monitoring
Equipment)and EC80601-2-30(Electrical Medical
Equipment,parts 2-30:Particular requirements
forthesafety,includingessentialperformance,
ofautomatic non-invasiveblood pressuremon-
itoring equipment).
• The accuracy of this blood pressure monitor has
been tested correctlyand its durability hasbeen
designed for long-term use. Technical meas-
urement checks must be carried out using the
appropriate methodswhenthedevice isused for
medical purposes. For accurate information on
how tocheck the accuracy of the device, you can
send a requestby post tothe after-salesservice.
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
dispose of itin an environmentallyfriendlyway and
in accordance with the law.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
“ABPM-100” Lot001 LA090206 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 a result of normal wear to this product. In
addition, the guarantee covering this LANAFORM
product does not cover damage caused by abusive
or inappropriate or incorrect use, accidents, theuse
of unauthorized accessories, changes made to the
product orany other circumstance, ofwhatever sort,
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 periodof two yearsfrom
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
Service Centre.Anyattempttomaintain thisproduct
by a person other than LANAFORM’s Service Centre
will render this guarantee void. •