ERKA. ERKAMETER 125 PRO User manual

USER MANUAL
ERKAME TER 125 PRO
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Register your device at
www.erka.org/xxl-garantie
USER MANUAL
DIGITALES OBERARMBLUTDRUCKMESSGERÄT
ERKAMETER 125 PRO
English 4 - 44
Français 46 - 86
Deutsch 88 - 128
Español 130 - 170
Italiano 172 - 212
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Blood pressure
measurement redened!
INNOVATION
Made in Germany.
Congratulations and thank you for placing your trust in us!
You have made the decision to purchase a quality product
from ERKA. Just like you, millions of doctors worldwide place
their trust in us – day after day.
As a pioneer in blood pressure measurement, ERKA. has been
helping millions of doctors perform their daily tasks for 125
years. We have combined these experiences, based on the
trust placed in us by our users, to develop an innovative,
digital blood pressure monitor for physicians. Absolute preci-
sion, the latest scientic measurement method – validated in
line with the strict protocol dened by the European Society
of Hypertension (ESH) – and perfect design: the Erkameter
125 PRO.
To make sure that you achieve the desired success and enjoy
using your Erkameter 125 PRO blood pressure monitor for a
long period of time, we recommend that you carefully read the
following information on using and maintaining your monitor.
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IMPORTANT INFORMATION! ALWAYS STORE IN A
SAFE PLACE!
Carefully read the instructions for use, especially the safety in-
formation, before using the device. The instructions for use are
part of the product and must be stored near the device, within
easy reach. Make sure that these instructions for use are inclu-
ded if you pass this device on to third parties. If you require
assistance when starting up, using or maintaining your device,
or if you wish to report unexpected or specic incidents, plea-
se contact the manufacturer at the following address:
ERKA. Kallmeyer Medizintechnik
Im Farchet 15, 83646 Bad Tölz
Free service hotline:
+8000 CALL ERKA (008000-2255 3752)
INTENDED USE
The Erkameter 125 PRO is an automatic, non-invasive blood
pressure monitor that can be used together with an inatable
cu for repeated, indirect blood pressure measurement without
arterial puncturing. This electrically powered ME DEVICE for
indirect blood pressure measurement without arterial punctu-
ring uses an automatic method to assess the blood pressure.
It can be used in both a clinical environment as well as for
medical care in a domestic environment.
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1 Start-up 8
1.1 Scope of delivery and packaging 8
1.2 The start screen 9
1.3 Start-up 11
1.3.1 Charging the battery 11
1.3.2 Switching your device on and o 11
1.3.3 Initial conguration 12
2 Blood pressure measurement 12
2.1 Prior to measuring the blood pressure 12
2.2 The RAPID measurement 16
2.3 The ADVANCED measurement 18
2.4 The CLASSIC measurement 20
2.5 Error messages 23
3 The readings memory 24
3.1 RAPID memory 24
3.2 ADVANCED memory 26
3.3 CLASSIC memory 26
4 System connection menu item 27
5 Integration into your practice software 27
TABLE OF CONTENTS
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6 Settings menu item 28
7 Notes and information 29
7.1 Patient safety 29
7.2 Operation, maintenance and care 32
7.3 Cleaning the device 34
7.4 Cleaning and maintaining the cu 34
7.5 Disposal information 34
8 Warranty and repair conditions 35
8.1 Statutory warranty35
8.2 XXL guarantee 35
9 Information on labelling and safety 36
9.1 Laws and provisions related to the product 36
a. Legend – icons on the device 36
b. Legend – icons in the instructions for use 36
c. Technical data 38
d. Manufacturer declaration on EMC
(electromagnetic compatibility) 39
e. Icons in the display 42
f. Icons of blood pressure measurement 43
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1 STARTUP
1.1 SCOPE OF DELIVERY AND PACKAGING
First, please check to ensure that the device is complete and that it does
not display any damage. In case of doubt, do not start-up the device and
contact your dealer or service centre.
Every device is identied by a unique serial number that is placed in a
clearly visible position on the rear of the device. You can use the serial
number to determine the year of manufacture of your device: the rst two
numbers indicate the year of construction in the YY format.
The scope of delivery includes:
1 digital ERKA Erkameter 125 PRO blood pressure monitor with either:
one GREEN CUFF Smart rapid cu, grey,
Size 3, adult, small (20.5-28 cm) Order number: 411.26493
Size 4, adult (27-35 cm) Order number: 411.20493
Size 5, adult, large (34-43 cm) Order number: 411.24493
1 storage pouch/case
1 USB cable
1 mains connector
4 plug adapters (USA/Canada/Japan,Australia,UK/EU)
1 warranty card
1 instructions for use
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WARNING: Keep packaging lm out of the reach of children.
Risk of suocation!
1.2 THE START SCREEN:
The Erkameter 125 PRO is equipped with an innovative touch screen.
The entire navigation takes place by lightly touching the specic function
icon on the display. The„Conrm selection/entry“,„To the main screen“
and„Back one level“ functions are controlled by the left and right naviga-
tion button as well as the ERKA. -Button.
Multi-function ERKA. -Button
with ON function
Right navigation button
Left navigation button
„HOME“ touch button
(back to the main screen)
„BACK“ touch button (back one level)
„DISCARD“ touch button
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Tube connection
Date and time display Battery status display
Touch display with
eight program symbols
ERKA. -Button with
ON function and
conrm function
Left navigation button
Right navigation button
USB connection
THE START SCREEN
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1.3 STARTUP
1.3.1 CHARGING THE BATTERY
Please fully charge your device‘s battery before initial use. The Erkameter
125 PRO has a permanently installed lithium polymer battery with no
memory eect. You can charge the battery at any time without having to
consider discharge times. A full charge is performed in two steps and takes
up to four hours.
The mains connector has to be tted with the relevant plug adapter for
the specic country.
Then connect the USB connection to the device using the enclosed
USB cable. The other end of the USB cable then has to be connected
to the mains connector before this is inserted in the socket.
INFORMATION ABOUT RECHARGEABLE BATTERY. The recharge-
able battery is a lithium-ion battery with no memory eect. You can
charge the battery at any time without having to consider discharge times.
A fully charged battery is sucient for seven days of recording.
The battery may only be charged at an ambient temperature of 10-45°C.
Do not charge the battery in direct sunlight or on a heater.
1.3.2 SWITCHING YOUR DEVICE ON AND OFF
To switch the device on, hold down the ERKA. -Button for about
3 seconds. The device switches o automatically after about 30 seconds
if no other buttons are pushed. It can also be switched o in the start
screen by pressing the OFF icon.
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1.3.3 INITIAL CONFIGURATION
To switch the device on, hold down the ERKA. -Button for about 3
seconds. You will be taken directly to the initial conguration menu when
rst switching on your device. This is where you can perform the following
settings:
DATE
Set the current date in the dd/mm/yyyy format using the navigation
buttons. Conrm the entry using the ERKA. -Button
TIME
Set the current time in 12h or 24h format using the navigation
buttons. Conrm the entry using the ERKA. -Button.
The 12h or 24h format is congured by the language selection.
Language
Select the system language, German or English. The setting has
an eect on the date and time display. Conrm the entry using the
ERKA. -Button.
2 BLOOD PRESSURE MEASUREMENT
2.1 PRIOR TO MEASURING THE BLOOD PRESSURE
Selecting the right cu size and the correct cu position of the blood pres-
sure cu are critical for successful blood pressure measurement; this is the
most common source of errors for inaccurate measurements.
CORRECT CUFF POSITION
IMPORTANT: THE CUFF SIZE MUST BE CORRECT!
The device is equipped with a cu for adults as standard. This cu is
suitable for an upper arm circumference of 27-35 cm. Other cu sizes
can be selected for dierent arm circumferences.
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First insert the free end of the cu air tube into the connection
provided on the device.
Open the cu to form a ring and t this over the bare left upper
arm, above the elbow. Make sure that the arm is not aected by the
hitching up of the sleeve in the event of tight-tting clothing.
The cu must be positioned about 2 nger widths above the elbow
with the tube pointing in the direction of the wrist. The cu itself must
not be twisted at all.
The arrow printed on the cu must be positioned over the brachial
artery.
Close the cu so that it is close-tting but not constricting.
Tighten the end of the cu fed through the cu bracket and press it
against the Velcro.
PLEASE NOTE: The Erkameter 125 PRO has an automatic
switch-o function that is triggered if the device is not used
for 30 seconds. As a result, take the time to calmly position the blood
pressure cu on the arm and then conrm that it has been positioned
correctly. Then switch on your device and start the blood pressure
measurement.
2- 3 cm
Marking
Artery
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THE CORRECT MEASURING POSITION
Perform the measurement while seated. Pay attention to the following:
Make sure you are in a comfortable sitting position,
Do not cross your legs,
Place your feet at on the oor,
Support your back and arm,
Place the centre of the cu at the height of the right atrium.
Relax your arm and place it on a table, for example. Remain calm and
relaxed during the measurement. Do not move or speak, as this may
change the measurement results.
The following must be noted when taking the blood pressure:
Seated measurement after 3-5 minutes of rest prior to the measurement
At least two blood pressure measurements at an interval of 1 to 2
minutes in a seated position and additional conrmation measure
ments, if the rst two measurements dier signicantly. The averaging
of the blood pressure values may be considered.
Repeat the measurements in order to improve the accuracy for patients
with arrhythmias, e.g. atrial brillation.
The cu must be positioned at heart height.
For auscultatoric methods, pay attention to the disappearance of the
Korotko sounds to identify the systolic and diastolic blood pressure
(phase I and V).
The blood pressure should be measured on both arms as part of an
initial examination. The higher blood pressure value is the reference
value.
In order to detect orthostatic hypotension for older patients, diabetics
or other common illnesses, the rst measurement should take place
while standing, after 1 and 3 minutes.
For conventional blood pressure measurements, the heart rate should
be detected by feeling for the pulse (at least 30 seconds) in a seated
position after the second measurement.
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THREE TYPES OF BLOOD PRESSURE MEASUREMENT
USING THE ERKAMETER 125 PRO
As a pioneer in blood pressure measurement, ERKA has been helping mil-
lions of doctors perform their daily tasks for 125 years. We have combined
these experiences, based on the trust placed in us by our users, to develop
an innovative, digital blood pressure monitor for physicians. Absolute
precision, the latest scientic measurement method – validated in line with
the strict protocol dened by the European Society of Hypertension (ESH) –
and perfect design: the Erkameter 125 PRO.
The individual RAPID, ADVANCED and CLASSIC methods of measure-
ment perfectly complement each other and were developed based on
the recommendations by the ESH and the daily requirements of everyday
medical practice. Moreover, the innovative design and the ease of use of
the Erkameter 125 PRO means that it can be used in almost every medical
situation.
RAPID MEASURING MODE: Whether in the hospital or in the
doctor‘s oce – each routine physical examination starts with a
thorough measurement of blood pressure. The Erkameter 125 PRO quickly
and accurately determines blood pressure with a fully automatic single
measurement. The integrated memory documents up to 500 readings.
These are then clearly displayed and available for further processing and
analysis.
ADVANCED MEASURING MODE:Accurate blood pressure
measurement in routine practice is even more convenient in the
ADVANCED measuring mode. The measurement is fully automatic and the
blood pressure value is calculated from the average of two single measure-
ments in accordance with the„Guidelines for the prevention, detection, dia-
gnosis and treatment of arterial hypertension“ by the German Hypertension
League. This scientically based approach corresponds to the conventional
understanding of correct medical blood pressure measurement.
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THE CLASSIC MEASUREMENT MODE supports the physician
in his or her profession and is used for special groups of
patients, such as infants, children or pregnant mothers. The measurement
is taken by auscultation with the stethoscope; only the pumping and me-
mory is performed by the Erkameter 125 PRO.
2.2 THE RAPID MEASUREMENT
PERFORMING THE RAPID MEASUREMENT
Start your Erkameter 125 PRO by holding down the
ERKA. -Button.
The start screen appears in the display accompanied
by an acoustic signal.
Select the RAPID measuring mode, identied by the
fast forward icon.
Position the blood pressure measurement cu on the
left arm.
A note on the screen asks you to double-check the
position and size of the blood pressure cu.
Conrm this screen and perform the measurement by
pressing the ERKA. -Button.
Press the HOME button in order to interrupt the mea-
surement preparations and return to the main menu.
The Erkameter 125 PRO automatically slowly inates
the cu to measure the blood pressure. The pressure
display changes constantly during ination.
The device inates the cu until an adequate pressure
for the measurement is reached. The device then slowly
releases the air from the cu and performs the measur-
ment.
You can terminate the measurement at any time by
pressing the ERKA. -Button.
e
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It displays the determined blood pressure value by
indicating the systolic pressure, the diastolic pressure,
the mean arterial blood pressure and the pulse.
The Erkameter 125 PRO automatically stores the rea-
dings in the RAPID measurements memory, which can
be accessed directly from this menu (left navigation button
–> memory icon). You can move back to the main menu
by pressing the BACK button.).
If you want to start another RAPID measurement, please
press the ERKA. -Button.
BLOOD PRESSURE MEASUREMENT TERMINOLOGY
systolic pressure:„Systole“ is the medical term for the phase of the
pumping process in which the heart contracts and ejects blood.
diastolic pressure: the diastolic blood pressure value represents the
lowest pressure in the vascular system, a base pressure, to which the
vessels are permanently exposed.
the mean arterial blood pressure is the mean blood pressure, i.e. the
mean blood pressure independent of the systolic and diastolic uctua-
tions in the vascular system.
pulse frequency: the pulse frequency refers to the number of pulses
for a specic unit of time (generally 1 minute).
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2.3 THE ADVANCED MEASUREMENT
PERFORMING THE ADVANCED MEASUREMENT
Start the Erkameter 125 PRO by holding down the
ERKA. -Button for 3 seconds.
The start screen appears accompanied by an acoustic
signal.
Select the ADVANCED measuring mode, identied by
the doctor icon.
Conrm your selection by pressing the ERKA. -Button.
Position the blood pressure measurement cu on the
left arm.
A note on the screen asks you to double-check the
position and size of the blood pressure cu.
Conrm this screen and perform the measurement by
pressing the ERKA. -Button.
Press the HOME button in order to interrupt the mea-
surement preparations and return to the main menu.
The clock icon, which changes over time, appears in
the display; the ination process starts after 60 seconds.
The patient should remain motionless and come to rest
during this period in order to establish optimal measuring
conditions.
You can terminate the measurement at any time by
pressing the ERKA. -Button.
e
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The Erkameter 125 PRO automatically slowly inates
the cu to measure the blood pressure. The pressure
display changes constantly during ination.
The device inates the cu until an adequate pressure
for the measurement is reached.
The device then slowly releases the air from the cu
and performs the measurement.
You can terminate the measurement at any time by
pressing the ERKA. -Button.
The clock icon, which changes over time, once again
appears in the display at the end of the rst measure-
ment.
The second measurement starts after a further
60 seconds.
The patient should remain motionless and come to rest
during this period in order to establish optimal measuring
conditions.
You can terminate the measurement at any time by
pressing the ERKA. -Button.
The Erkameter 125 PRO automatically slowly inates
the cu to measure the blood pressure. The pressure
display changes constantly during ination.
The device inates the cu until an adequate pressure
for the measurement is reached.
The device then slowly releases the air from the cu
and performs the measurement.
You can terminate the measurement at any time by
pressing the ERKA. -Button.
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It displays the determined blood pressure value by
indicating the systolic pressure, the diastolic pressure,
the mean arterial blood pressure and the pulse.
The Erkameter 125 PRO automatically stores the
readings in the ADVANCED measurements memory,
which can be accessed directly from this menu
(–> memory icon).
If you want to start another ADVANCED measurement,
please press the ERKA. -Button.
BLOOD PRESSURE MEASUREMENT TERMINOLOGY
systolic pressure:„Systole“ is the medical term for the phase of the
pumping process in which the heart contracts and ejects blood.
diastolic pressure: the diastolic blood pressure value represents the
lowest pressure in the vascular system, a base pressure, to which the
vessels are permanently exposed.
the mean arterial blood pressure is the mean blood pressure, i.e. the
mean blood pressure independent of the systolic and diastolic uctua-
tions in the vascular system.
pulse frequency: the pulse frequency refers to the number of pulses
for a specic unit of time (generally 1 minute).
2.4 THE CLASSIC MEASUREMENT
PERFORMING THE CLASSIC MEASUREMENT
Start the Erkameter 125 PRO by holding down the
ERKA. -Button for 3 seconds.
The start screen appears accompanied by an acoustic
signal.
Select the CLASSIC measuring mode, identied by the
stethoscope icon.
Conrm your selection by pressing the ERKA. -Button.
e
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