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Instructions for use
Upper arm
BASIS CONTROL
The No. 1 blood pressure monitor
in German pharmacies
*
* Top-selling in German pharmacies, IMS Health Pharmatrend Database –
digital blood pressure monitor sales, date 02/2019
** Warr anty o f 2 years on blo od pressu re monit or cuff as a w earing par t
User
Memory cells
Also suitable for:
CLINIQUEMENT
VALI DÉ
ANS DE
GARANTIE
**
pressure scale
DiabeticKidney disease
Blood
Pregnant
women
Arrhythmia
detection
Children
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aponorm® Basis Control
2
1
3
5
4
6
10
8
9
7
16
15
19
18
-B
18
-A
14
18
-C
18
-D
18
-E
17
20
11
12
13
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aponorm® Basis Control
Switches, housing and accessories
1
On/off button
2
Display
3
M button (Memory)
4
Time button
5
Cuff socket
6
Mains adapter connector
7
Battery compartment
8
Cuff
9
Cuff connector
10
Cuff hose
Important! Please observe the information in this booklet in order to prevent damage
to the device and avoid error messages.
Protect from moisture.
Display
11
Systolic value
12
Diastolic value
13
Pulse indicator
14
Battery level indicator
15
Blood pressure evaluation indicator
16
Stored value
17
Pulse rate measurement active
18
Cuff check
-A: Optimum cuff position and fit
-B: Cuff signal error indicator «Err 1»
-C: Cuff position/fit not optimal
-D: Arm movement error indicator «Err 2»
-E: Cuff pressure error indicator «Err 3»
19
Heart arrhythmia warning symbol (PAD)
20
Date/time indicator
Read the instructions carefully before using this monitor.
BF specification part.
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aponorm® Basis Control
Designated use:
This oscillometric blood pressure monitor serves
for non-invasive measurement of the blood pressure of persons aged 12 years or older.
It is clinically validated for patients suffering from
hypertension, diabetes, pregnant women, pregnant
women suffering from preeclampsia, atherosclerosis, kidney diseases, obesity and for the elderly.
Dear Customer,
This instrument was developed in collaboration
with physicians and clinical tests prove its measurement accuracy to be very high.*
If you have any questions or problems or want to
order spare parts, please contact the aponorm®
customer service at the product website www.
aponorm.de or the distributor where you purchased
the monitor. The product website provides much
additional useful information on your product.
Stay healthy – the aponorm® team!
* This device uses the same measuring technology as the
award winning «BP 3BTO-A» model tested according to the
British Hypertension Society (BHS) protocol.
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Table of contents
1. Using the monitor for the first time
· Inserting the batteries
·
Setting the date and time 6
·
Selecting the correct cuff 6
2. Check list for reliable measurement
3. Taking a blood pressure measurement
· Manual inflating
·
Not storing a reating 8
· How do I evaluate my blood pressure
· Indication of pulse arrhythmia
4. Data memory
· Viewing the stored values
· Clearing all values
5. Battery indicator and battery change
· Batteries almost flat
· Batteries flat - battery replacement
· Which batteries and which procedure?
· Using rechargeable batteries
6. Using a mains adapter
7. Error messages and problems
10
6
8
10
10
10
11
6
7
? 9
(PAD) 9
10
11
11
12
8. Safety, care, accuracy test and disposal 14
· Safety and protection
· Monitor care
· Cleaning the cuff
· Accuracy test
· Disposal
7
9. Warranty terms
10. Technical data
Warranty card
10
16
19
14
15
15
15
16
17
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1. Using the monitor for the first time
Inserting the batteries
After having unpacked the monitor, insert the batteries. The battery compartment 7 is on the bottom
of the monitor. Insert the batteries (4 x size AA
1.5 V), observing the indicated polarity +/-.
Setting the date and time
1. After the new batteries are fitted, the year
3
flashes in the display. Press the M button
several times to set the year. To confirm the
year you want to set, press the time button 4.
2. Now you can set the present month in the
3
same way, using the M button
and confirm
your setting by pressing the time button 4.
3.Follow the instructions above to set the day,
hour and minutes.
4. Once you have set the minutes and confirmed
the setting, the date/time setting is complete.
When the monitor is not in operation, it dis-
20
plays the time
. The date, however, is only
required for the memory display.
If you want to change the date and time
subsequently, press and hold the time button
down for approx. 3 seconds until the year starts
to flash. Now you can enter the new values as
described above.
Selecting the correct cuff
Microlife offers different cuff sizes. Select the cuff
size to match the circumference of your upper arm
(measured by close fitting in the centre of the upper
arm).
8
If the cuff
coming with the monitor does not fit,
please contact your local pharmacist who can order
an alternative size for you.
Cuff size for circumference of
upper arm
S 17 - 22 cm
M 22 - 32 cm
M - L 22 - 42 cm
In addition to the above-mentioned soft cuffs,
a preformed comfort cuff is available in M - L,
one size fits all.
Use onlyaponorm
®
cuffs or cuffs manufactu-
red by Microlife.
®
All aponorm
cuffs are latex-free.
Connect the cuff to the monitor by inserting
9
the cuff connector
into the cuff socket 5 as
far as it will go.
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2. Check list for performing
reliable measurements
Please read the enclosed flyer on the “8 golden
rules of taking the blood pressure”.
Avoid activity, eating or smoking immediately
before taking the measurement.
long bar) must lie over the artery which runs
down the inner side of the arm.
· Support your arm so it is relaxed.
· Ensure that the cuff is at the same height as
your heart.
Sit down on a chair with a backrest and relax
for at least 5 minutes. Keep your feet flat on
the floor and do not cross your legs.
Always take your blood pressure on the same
arm (normally the left one). It is recommended that doctors perform double arm
measurements on a patient’s first visit in
order to determine which arm to measure in
the future. Select the arm where the higher
blood pressure was determined.
Remove close-fitting garments from the upper
arm. To avoid constriction, shirt sleeves should
not be rolled up - they do not interfere with
the cuff if they are laid flat (please take off any
heavy clothing, as it interferes with the signal).
Always ensure that the correct cuff size is used
(see on the cuff for size information).
· Fit the cuff closely, but not too tight.
· Make sure that the cuff is positioned 2.5 cm
above the crook of the arm.
· The artery mark on the cuff (approx. 3 cm
3. Taking the blood pressure
1. Press the On/off button 1 to start the measurement.
2.The cuff will now inflate automatically. Relax,
do not move and do not tense your arm
muscles until the reading is displayed. Breathe
normally and do not talk.
3. If after a short while a cuff symbol appears
18
with a check mark (
pressure are optimal for measurement. If there
is no mark inside the cuff symbol (18-C) signal
and/or pressure are less than optimal, but still
sufficient for proper measurement. If, however,
the cuff signal and pressure are absolutely too
low for measuring or if there are excessive
interferences (e. g. due to the patient moving,
tensing their muscles or talking, etc.), an
error message «ERR» (Error) will be displayed
together with one of the cuff symbols 18-B,
-A), the cuff signal and
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18
-D or 18 -E. In this case re-position the cuff
and repeat the measurement. For other error
messages, please read chapter 7 on page 12
4. Once the correct pressure is reached, the
inflating stops and the pressure gradually falls.
If the required pressure was not reached, the
monitor will automatically pump some more
air into the cuff until the blood pressure can be
taken.
5. During the measurement, the “pulse rate mea-
17
surement active” icon
6. The result, comprising the systolic
flashes in the display.
11
and the
diastolic 12 blood pressures and the pulse rate
per minute 13 is displayed.
7. When the monitor has finished measuring,
remove the cuff.
8. Switch off the monitor. (The monitor does
switch off automatically after approx. 1 minute,
though).
You can stop the measurement at any time
by pressing the On/Off button (e.g. if you feel
uneasy or an unpleasant pressure sensation).
This monitor is specially tested for use in
pregnancy and preeclampsia. When you detect
unusually high readings in pregnancy, take your
blood pressure again after a short while (approx.
1 hour). If the reading is still too high in the
.
repeat measurement, please contact your doctor
or gynaecologist.
Manual inflation
In case of very high systolic blood pressure (e. g.
exceeding 135 mmHg), it can be of use that you
determine the pressure yourself. Press the On/
off button after the monitor started inflating and
a pressure of approx. 30 mmHg appears in the
display. Keep the button pressed until the pressure
is about 40 mmHg above your average systolic
value – then release the button.
How not to store a reading
As soon as the result appears in the display, press
1
the on/off button
16
is flashing. Confirm the deletion by pressing the
and keep it pressed until «M»
time button 4.
«CL» is shown after the reading was successful-
ly deleted from the memory.
How do I evaluate my blood pressure?
The triangle at the left edge of the display
points at the range your blood pressure reading is
in. The reading is either in the optimum (white),
increased (cross-hatched in grey) or high (black)
blood pressure range. The classification corres-
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ponds to the following ranges defined by international guidelines (ESH, ESC, JSK) (values in mmHg).
Range
Blood
1.
pressure
too high
Blood
2.
pressure
elevated
The higher value is the one that determines the
evaluation. Example: a blood pressure value of
140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».
Pulse arrhythmia indicator (PAD)
This symbol
larities were detected during the measurement. If
the result deviates from your normal blood pressure repeat the measurement. In most cases, this
is no cause for concern. However, if the symbol
appears on a regular basis (e.g. several times a
week with measurements taken daily) we advise
you to tell your doctor.
Systolic
≥ 135 ≥ 85
130-134 80-84
19
indicates that certain pulse irregu-
Diastolic
Recommendation
Seek medical
advice
Self-check
4. Data memory
This monitor automatically stores the last 30
readings.
Viewing the stored values
3
Press the M-button
switched off. Now the display changes over to the
data memory display, indicated by «M» 16
(= Memory).
First, the average value of all measurement stored
in the memory is shown, as indicated by the «A» to
the right of the value (A = Average).
Pressing the M button again displays the last value. Pressing the M button repeatedly allows you to
move from one stored value to another (from the
last to the first entry in the memory).
Blood pressure readings with the cuff posi-
tion and fit 18-C being not optimal are not
included in the average.
Pay attention that the maximum memory
capacity of 30 values is not exceeded. Once
the memory is full, the oldest value is
automatically overwritten with the 31st
value. The values should be evaluated by
a doctor before the full memory capacity is
reached - otherwise data will be lost.
briefly, when the monitor is
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Clearing all values
If you are sure that you want to permanently
remove all stored values, hold down the M
button (the monitor must have been switched off
beforehand) until «CL ALL» (= Clear all) appears
and then release the button. To permanently clear
the memory, press the M button while «CL ALL» is
flashing.
Simply press the On/off button 1 again
while «CL ALL» is flashing to abort the deletion.
It is not possible to delete individual readings.
5. Battery indicator and battery
change
Batteries almost flat
When the batteries are approx. 3/4 empty the
14
partly filled battery symbol
the device is switched on. Although the monitor
will continue to measure reliably, you should
obtain replacement batteries.
Batteries flat - replacement
When the batteries are flat an empty battery
14
symbol
switched on. You cannot take any further measurements and must replace the batteries.
10
will flash as soon as the monitor is
will flash as soon as
In the event of a battery change or power
failure, the memory retains all values measured; the date and time must, however, be
reset. This is indicated by the year indicator
flashing.
For changing the batteries and resetting the date/
time please follow the instructions in Section 1 on
page 6.
Which batteries and which procedure?
Please use 4 new, long-life 1.5 V, size AA
alkaline batteries.
Do not use batteries beyond their date of
expiry.
If the monitor is not going to be used for a
prolonged period of time, the batteries must
be removed.
Using rechargeable batteries
You can also operate this monitor with rechargeable batteries.
Only use «NiMH» type reusable batteries.
When the flat battery symbol appears,
remove the batteries and recharge them.
They must not remain in the monitor as they
may become destroyed (exhaustive discharge
due to low consumption of the monitor even
when switched off).
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Always remove the rechargeable batteries
if you do not intend to use the monitor for a
week or more.
The batteries canNOT be charged while
inserted in the blood pressure monitor. Recharge
the batteries in an external charger and observe
the information regarding charging, handling and
durability.
6. Using a mains adapter
You can operate this monitor using the Microlife
mains adapter (DC 6 V, 600 mA).
Only use the aponorm® mains adapter availa-
ble as an original accessory appropriate for
your supply voltage. You can purchase the
mains adapter in your local pharmacy.
Ensure that neither mains adapter nor cable
are damaged.
1. Plug the adapter cable into the mains adapter
6
socket
2. Plug the adapter plug into the wall socket.
of the blood pressure monitor.
just as a back-up. They ensure that in the event of
a power failure date and time are retained and do
not have to be entered manually again.
7. Error messages
When an error occurs during a measurement, the
measurement is interrupted and an error message
displayed, e.g. «Err 3».
If you do not receive an error message, but
if the results seem unusual to you, please
check whether you observed all points of the
check list on page 7 and in the enclosed flyer
“8 golden rules of taking the blood pressure”.
For more detailed help in troubleshooting the
monitor, please refer to the download section
of the www.aponorm.de product website.
When the mains adapter is connected, no battery
current is consumed. We recommend to have batteries in the monitor even with mains operation,
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Error Designa-
tion
-B
-D
Signal too
weak
Interference
signal
«ERR 1»
18
«ERR 2»
18
Potential cuase and
remedy
The pulse signals on
the cuff are too weak.
Re-position the cuff and
repeat the
mea-sure-ment.*
When «ERR 1» is
indicated, the monitor performs a 15
second countdown
and then repeats
the measurement.
During the measurement,
interference signals
were detected by the
cuff, caused for instance
by movement or muscle
tension. Repeat the
measurement, keeping
your arm still.
Error Designa-
tion
-E
Irregular
cuff pres-
«ERR 3»
18
sure
«ERR 5»
Irregular
measuring
result
«HI»
Pulse rate
or cuff
pressure too
high
Potential cuase and
remedy
It is not possible to build
up sufficient pressure in
the cuff.
A leak may have occurred. Check that the
cuff connection is correct
and that the cuff is not
too loose around your
arm. Replace the batteries if necessary. Repeat
he measurement.
The measuring signals
are inaccurate and no
result can therefore be
displayed. Read through
the check list for performing reliable measurements and repeat the
measurement.*
The pressure in the cuff
is too high (over 299
mmHg) or your pulse
rate is too high (over 200
beats per minute). Relax
for 5 minutes and repeat
the measurement.*
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Error Designa-
tion
«LO»
* Please consult your doctor, if this or any other
problem occurs repeatedly
Pulse too
low
Potential cuase and
remedy
The pulse rate is too
low (less than 40 beats
per minute). Repeat the
measurement.*
instructions carefully and retain them for
future reference.
· This device may only be used for the purposes
described in these instructions. The manufacturer will not accept any liability for damage
caused by improper use.
· This device comprises sensitive components
and must be treated with caution.
Observe the storage and operating conditions
described in Section 10 on page 17.
· Protect the monitor from:
water and moisture
extreme temperatures
impact and falls
contamination and dust
direct sunlight
heat and cold
· The cuffs are rather delicate and must be
handled with care.
8. Safety, care, accuracy test
and disposal
Safety and protection
· Carefully follow these instructions. This
document gives important information on the
operation and safety of this monitor. Before
using the monitor, please read these
· Do not use any other cuffs or cuff connectors
for measurements with this monitor.
· Only inflate the cuff once fitted.
· Do not use this monitor close to strong electromagnetic fields such as mobile telephones
or radio installations. We recommend observing a minimum distance of 3.3 m from
such devices when using this monitor.
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· Do not use this monitor if you think it is
damaged or if you notice anything unusual.
· Never open the monitor.
· If the monitor is not going to be used for a
prolonged period of time, the batteries must
be removed.
· Read the additional safety information in the
individual sections of these instructions.
·
The measuring result shown by this monitor
is NOT a diagnosis. It is not a substitute for a
professional evaluation by a physicist, in particular not if the result does not correspond
to the patient’s physical condition. Never rely
on blood pressure measurements alone. All
potential symptoms and the patient’s statements must be taken into consideration. If
necessary, call an ambulance or a physician.
· Deviations between measurements taken
by your doctor or in the pharmacy and those
taken at home are quite normal, as these
situations are completely different.
· The pulse rate display is not suitable
for checking the frequency of heart
pacemakers!
· If you are pregnant, you should monitor your
blood pressure very closely as it can change
drastically during this time!
Do not let unsupervised children use
the monitor. Some of the components
are so small that children can swallow
them or choke on them. Beware of the
risk of strangulations in case this
monitor is fitted with cables or tubes.
Monitor care
· Permanently high blood pressure values
can damage your health and must be
treated by your doctor!
· Always discuss your values with your doctor
and tell them if you have noticed anything
unusual or feel unsure. Never rely on blood
pressure readings alone.
· Under no circumstances should you alter
the dosages of any drugs prescribed or
start medication without consultation
with your doctor.
14
Clean the monitor only with a soft, dry cloth.
Cleaning the cuff
Remove stains on the cuff carefully with a damp
cloth and soapsuds or a commercial disinfectant.
WARNING: Do not wash the cuff in a
washing machine or a dishwasher!
WARNING: Do not dry the cuff in a tumble
dryer!
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Accuracy test
We recommend to have this monitor tested for
accuracy every 2 years or after severe mechanical
impact (e.g. the device dropped to the floor).
®
Please contact the aponorm
customer service on
the website www.aponorm.de.
Disposal
Batteries and electronic devices must not be
disposed of as normal domestic trash. They
must be disposed of in accordance with the
applicable local provisions.
9. Warranty terms
We are confident in the quality of our aponorm®
blood pressure monitors. Therefore we, WEPA
Apothekenbedarg GmbH & Co. KG, grant end
customers who are private consumers, a voluntary
5 year warranty for all aponorm® blood pressure
monitors purchased in Germany, subject to the
following terms:
Subject matter and scope of the warranty
®
The warranty applies to all aponorm
sure monitors which customers in their capacity as
consumers purchased in Germany. WEPA Apothekenbedarf GmbH & Co. KG warrants the customer
blood pres-
that the product is free from defects in material
and workmanship. Should, despite proper handling
of the product, a defect occur within the 5-year
warranty period, WEPA Apothekenbedarf GmbH
& Co. KG will repair the product free of charge
(except for the transport costs for returning the monitor to WEPA) or fully replace it at its discretion.
Exclusion of warranty
No claims can be derived from this warranty in
case of damage caused by the customer’s or third
parties’ negligence such as drop, accident or
improper handling. The same applies to damage
caused by leaking batteries or failure to observe
the operating instructions.
Warranty by WEPA Apothekenbedarf GmbH &
Co. KG is also excluded if a defect/damage was
caused by an improper repair or other third party
interventions.
The warranty does not cover wear parts, accessories (e.g. pouches, cables, etc.), batteries and the
cuff forming part of the product. We grant a functional guarantee of 2 years on the cuff (tightness of
the inner chamber).
Warranty period
The warranty covers a period of 5 years from the
date of purchase (warranty period). The relevant
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proof is the date of the proof of purchase or of the
warranty card with purchase date filled in by the
distributor.
The warranty period is not extended by the fact
that benefits under this warranty were granted, in
particular not in the event of a repair or exchange
of the product. In such cases, the warranty does
not recommence.
Assertion of warranty claims
Within the warranty period, the customer can
claim his/her rights under this warranty by presenting the faulty product and the proof of purchase or
the warranty card filled in by the distributor directly
to WEPA Apothekenbedarf GmbH & Co. KG or the
distributor where the customer had purchased the
product.
If the fault/damage is covered by the warranty,
WEPA Apothekenbedarf GmbH & Co. KG will repair
the product free of charge (except for the transport
costs for returning the monitor to WEPA) or fully
replace it at its discretion.
If it is found that the fault/damage is not covered
by the warranty, the product can be repaired by
WEPA Appthekenbedarf GmbH & Co. K at the
customer’s expenses. In this case, WEPA Apothekenbedarf GmbH & Co. KG informs the customer
of the estimated costs in a cost estimate before
starting the repair work. The customer is free to
16
commission the repair of the product with costs or
to request the return of the unrepaired product.
Further customer rights
WEPA Apothekenbedarf GmbH & Co. KG grants
the warranty subject to the terms and conditions
stated. Customer can have further statutory rights.
The contractual and statutory rights of customers,
in particular the statutory warranty rights against
the seller of the product, shall not be affected by
the warranty.
The warranty is governed by the legislation of the
Federal Republic of Germany. Date: 10/2018
10. Technical data
Operating 10 - 40 °C / 50 - 104 °F
conditions: 15 - 95% relative maximum
air humidity
Storage -20 - +55 °C / -4 - +131 °F
conditions: 15 - 95 % relative maximal
air humidity
Weight: 277 g /with batteries)
Size: 131 x 90 x 60.5 mm
Measuring method: oscillometric, validated
by the Korotkoff method:
phase I systolic,
phase V diastolic
Page 17
Measuring range: 20 - 280 mmHg – blood
pressure
40 - 200 beats per minute pulse rate
Cuff pressure
display range: 0 - 299 mmHg
Measuring resolution: 1 mmHg
Static accuracy: pressure within
± 3 mmHg
Pulse rate accuracy: ± 5% of the reading
Soltage source: · 4 x 1.,5 V alkaline bBatte-
ries, size AA
· Mains adapter DC 6 V,
600 mA (optional)
Battery life: approx. 920 measurements
(with new batteries)
IP class: IP 20
Reference to EN 1060-1 /-3 /-4;
standards: IEC 60601-1;
IEC 60601-1-2 (EMC);
IEC 60601-1-11
This monitor complies with the requirements of the
Medical Device Directive 93/42/EEC.
Technical alterations reserved.
Áverage Monitor: 5 years or
service life: 10,000 measurements;
Accessories: 2 years
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aponorm® Basis Control – Warranty card
Name of customer
Serial number of
monitor (SN)
Date of purchase
Pharmacy stamp and
signature
aponorm® by
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Warranty card
To be on the safe side: the aponorm® warranty.
YEARS
WARRANT Y
Your new blood pressure monitor is a top-class precision medical device. We warrant this
**
with our name and our warranty.
Please refer to p. 16 of the instructions for the terms of warranty in detail.
Tips:
In case you lost the instructions for use with the terms of warranty during
your period of use of the monitor, you can at any time download them on the
Website
Here you also fi nd the instructions for use in German, Turkish, French and
Sold by:
WEPA Apothekenbedarf
GmbH & Co KG
Am Fichtenstrauch 6-10
D-56204 Hillscheid
www.aponorm.de
www.wepa-dieapothekenmarke.de
Download site at www.aponorm.de.
Russian for download.
Manufactured by:
Microlife AG
Espenstrasse 139
CH-9443 Widnau
www.microlife.ch
Assistive appliances No.:
21.28.01.2103
Order No. 047290
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