Mediblink M520 User manual

SLO Mediblink merilnik krvnega tlaka M520
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete navodila
za uporabo
EN Mediblink Blood Pressure Monitor M520
INSTRUCTIONS FOR USE
Please read the instructions for use carefully before using the product
HRV  MediblinkmjeračkrvnogtlakaM520
UPUTE ZA UPOTREBU
Pažljivo pročitajte upute prije upotrebe uređaja

2
EN
TABLE OF CONTENTS
1. Introduction 5
1.1 Features of M520 5
1.2 Important information about self-measurement 5
2. Important Information of Blood-Pressure Measurement 6
2.1 How does high / low blood-pressure arise? 6
2.2 Which values are normal? 6
3. The Various Components of the Blood-Pressure Monitor 8
4. Putting the Blood-Pressure Monitor Into Operation 9
4.1 Inserting the batteries 9
4.2 User selection and setting the time / date 9
5. Carrying Out a Measurement 10
5.1 Before the measurement 10
5.2 Common sources of error 11
5.3 Fitting the cu󰀨 11
5.4 Measuring procedure 12
5.5 Discontinuing a measurement 13
5.6 Memory – storage and recall of the measurements 13
5.7 Memory – cancellation of all measurements 13
6. Appearance of the Pulse Arrhythmia Indicator for Early Detection 13
7. Error Messages / Malfunctions 14
8. Care and Maintenance, Recalibration 15
9. Battery Life 16
10. Safety, Care and Disposal 16
11. Reference to Standards 17
12. Remark 17
13.TechnicalSpecications 18
14. Manufacturer’s Declaration 19
15. Warranty 21

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SLO
VSEBINA
1. Uvod 22
1.1 Funkcije merilnika krvnega tlaka M520 22
1.2 Pomembne informacije o samomerjenju 22
2. Pomembne informacije za merjenje krvnega tlaka 23
2.1 Kaj je vzrok za visok / nizek krvni tlak? 23
2.2 Katere vrednosti so normalne? 23
3. Različnekomponentemerilnikakrvnegatlaka 25
4. Pred uporabo merilnika krvnega tlaka 26
4.1 Vstavljanje baterij 26
4.2 Izbira uporabnika in nastavitev časa / datuma 26
5. Izvajanje meritve 27
5.1 Pred meritvijo 27
5.2 Pogosti viri napak 28
5.3 Nameščanje manšete 28
5.4 Postopek merjenja 29
5.5 Prekinitev merjenja 29
5.6 Pomnilnik – shranjevanje in priklic meritev 29
5.7 Pomnilnik – izbris vseh meritev 30
6. Prikazkazalnikazazgodnjeodkrivanjesrčnearitmije 30
7. Sporočilaonapakah/okvare 31
8. Negainvzdrževanje,ponovnoumerjanje 32
9. Življenjskadobabaterije 33
10. Varnost, nega in odstranjevanje 33
11. Sklicevanje na standarde 34
12. Pomen simbolov 34
13.Tehničnipodatki 35
14. Izjava proizvajalca 36
15. Garancijski list 38

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HRV
SADRŽAJ
1. Uvod 39
1.1 Značajke M520 39
1.2 Važne informacije o mjerenju krvnog tlaka kod kuće 39
2. Važneinformacijeomjerenjukrvnogtlaka 40
2.1 O krvnom tlaku 40
2.2 Koje su normalne vrijednosti krvnog tlaka? 40
3. Dijelovimjeračakrvnogtlaka 42
4. Početakradamjerača 43
4.1 Umetanje baterija 43
4.2 Odabir korisnika i podešavanje vremena 43
5. Mjerenje krvnog tlaka 44
5.1 Prije mjerenja 44
5.2 Najčešći izvori grešaka 44
5.3 Namještanje manžete 45
5.4 Postupak mjerenja 46
5.5 Prekid mjerenja 46
5.6 Memorija – Pohranjivanje i pregledavanje rezultata 46
5.7 Memorija – Brisanje svih zabilježenih rezultata 47
6. Indikator aritmije 47
7. Poruke greške / neispravnosti 48
8. Održavanjeuređaja/kalibracija 49
9. Vijek trajanja baterije 49
10. Sigurnost, briga i zbrinjavanje 50
11. Norme 51
12. Napomena 51
13.Tehničkekarakteristike 52
14.Izjavaproizvođača 53
15.Jamstvo 55

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1. Introduction
1.1 Features of M520
M520 with MDI, measuring in the ination, (with integrated time / date display)
is a fully automatic, digital blood-pressure measuring device for use on the arm,
which enables very fast and reliable measurement of the systolic and diastolic
blood-pressure as well as the pulse frequency by way of the oscillometric method
of measuring.
The device o󰀨ers very high and clinical tested measurement accuracy and has
been designed to provide a maximum of user-friendliness.
The device is intended for self-use in home.
Before using, please read through this instruction manual carefully and then keep
it in a safe place.
For further questions on the subject of blood-pressure and its measurement,
please contact your doctor.
Warning!
1.2 Important information about self-measurement
• Substitution of a di󰀨erent component might result in measurement error.
• Cu󰀨 is replaceable only by an original.
• Do not use with neonatal patients.
• It will cause harmful injury to the patient or a󰀨ect the blood pressure due to
connection tubing kinking.
• Too frequent measurements can cause injury to the patient due to blood ow
interference.
• The application of the cu󰀨 over a wound can cause further injury.
• The application of the cu󰀨 and its pressurization on any limb where intravascular
access or therapy, or an arteriovenous (A-V) shunt, is present because of
temporary interference to blood ow and could result in injury to the patient.
• Do not let the cu󰀨 and its pressurization on the arm on the side of a mastectomy.
• The need to check that operation of the automated sphygmomanometer does
not result in prolonged impairment of patient blood circulation.
• Not intended to be used together with HF surgical equipment.
• Do not forget: self-measurement means control, not diagnosis or treatment.
Unusual values must always be discussed with your doctor. Under no circumstances
should you alter the dosages of any drugs prescribed by your doctor.

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• The pulse display is not suitable for checking the frequency of heart
pacemakers!
• In cases of cardiac irregularity (Arrhythmia), measurements made with this
instrument should only be evaluated after consultation with the doctor.
Electromagnetic interference
The device contains sensitive electronic components (Microcomputer). Therefore,
avoid strong electrical or electromagnetic elds in the direct vicinity of the device
(e.g. mobile telephones, microwave cookers). These can lead to temporary
impairment of the measuring accuracy.
2. Important Information of
Blood-Pressure Measurement
2.1 How does high / low blood-pressure arise?
The level of blood-pressure is determined in a part of the brain, the so-called
circulatory center, and adapted to the respective situation by way of feedback via
the nervous system. To adjust the blood-pressure, the strength and frequency of
the heart (Pulse), as well as the width of circulatory blood vessels is altered. The
latter is e󰀨ected by way of ne muscles in the blood-vessel walls. The level of
arterial blood-pressure changes periodically during the heart activity: During the
“blood ejection” (Systole) the value is maximal (systolic blood-pressure value),
at the end of the heart’s “rest period” (Diastole) minimal (diastolic blood-pressure
value). The blood-pressure values must lie within certain normal ranges in order
to prevent particular diseases.
2.2 Which values are normal?
Blood pressure is too high if at rest, the diastolic pressure is above 90 mmHg and
/ or the systolic blood-pressure is over 160 mmHg. In this case, please consult
your doctor immediately. Long-term values at this level endanger your health due
to the associated advancing damage to the blood vessels in your body.
Should the systolic blood-pressure values lie between 140 mmHg and
160 mmHg and / or the diastolic blood-pressure values lie between 90 mmHg
and 100 mmHg, likewise, please consult your doctor. Furthermore, regular self-
checks will be necessary.
With blood-pressure values that are too low, i.e. systolic values under 100 mmHg
and / or diastolic values under 60 mmHg, likewise, please consult your doctor.

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Even with normal blood-pressure values, a regular self-check with your blood-
pressure monitor is recommended. In this way you can detect possible changes
in your values early and react appropriately. If you are undergoing medical
treatment to control your blood pressure, please keep a record of the level of
your blood pressure by carrying out regular self-measurements at specic times
of the day. Show these values to your doctor. Never use the results of your
measurements to alter independently the drug doses prescribed by your
doctor.
Table for classifying blood-pressure values (unit: mmHg) according to World
Health Organization:
Range &
broadcasting
Systolic
Blood-pressure
Diastolic
Blood-pressure
Measures
Optimal
Between 100 and 120 B etween 60 and 80 Self-check
Normal
Between 120 and 129 B etween 80 and 84 Self-check
High to
normal
Between 130 and 139 B etween 85 and 89 Consult your
doctor
Slight
hypertension
Between 140 and 159 Between 90 and 99 Seek medical
advice
Medium
hypertension
Between 160 and 179 Between 100 and 109 Seek medical
advice
Strong
hypertension
Higher than 180 Higher than 110 Urgently seek
medical advice!
Further information
• If your values are mostly standard under resting conditions but exceptionally
high under conditions of physical or psychological stress, it is possible that you
are su󰀨ering from so-called «labile hypertension». Please consult your doctor if
you suspect that this might be the case.
• Correctly measured diastolic blood-pressure values above 120mmHg require
immediate medical treatment.

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Memory Button
ON / OFF Button
Time and Date
Systolic Value
Diastolic
Value
Tra󰀩c Light Display
User
Memory Set No
Memory Symbol
Pressure Unit
Heart Arrhythmia Indicator
Heart Symbol
Pulse
Low Battery Warning
3. The Various Components of the
Blood-Pressure Monitor

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4. Putting the Blood-Pressure
Monitor Into Operation
4.1 Inserting the batteries
a) Insert the batteries (4 x size AA 1.5V), thereby observing the indicated polarity.
b) If the battery warning “ ” icon appears in the display, the batteries remain
20% power to warn user the batteries will be run out.
c) If the battery warning “ ” icon appears in the display, the batteries are
empty and must be replaced by new ones
Warning!
•After the battery warning “ ” icon appears, the device is blocked until the
batteries have been replaced.
•Please use “AA” Long-Life or Alkaline 1.5V Batteries.
•The use of 1.2V Accumulators is not recommended.
•If the blood-pressure monitor is left unused for long periods, please remove the
batteries from the device.
4.2 User selection and setting the time / date
User selection: This advanced blood pressure monitor allows you to track blood
pressure readings for 2 individuals independently.
a) Before measurement, make sure you set the unit for the intended user. The
unit can track results for 2 individuals (User 1, User 2).
b) Press the Memory button “”for at least 3 seconds. The
display now indicates the set user, during which the set user
blink, to conrm, press ON / OFF button.
c) Press the MEMORY button to select User.
d) We suggest the rst person to take their pressure to be User 1.
Setting the time, date
This blood-pressure monitor incorporates an integrated clock with date display.
This has the advantage, that at each measurement procedure, not only the blood-
pressure values are stored, but also the exact moment of the measurement.
How to enter to the setting mode:
After batteries are inserted, the device will enter the setting mode automatically.

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The setting procedure as follows:
It is essential to set date and time. Otherwise, you will not be able to save your
measured value correctly with a date and time.
To use “”button to be adjustment button.
If you press and hold “”button, you can set the values more
quickly.
1. Year setting: the year ashes on the display: choose the desired
year with “”button and conrm with “”(ON / OFF) button.
2.
Month setting: the month ashes on the display: choose the desired
month with “”button and conrm with “”(ON / OFF) button.
3. Day setting: the day ashes on the display: choose the desired
day with “”button and conrm with “”(ON / OFF) button.
4. Hour setting: the hour ashes on the display: choose the desired
hour with “”button and conrm with “”(ON / OFF) button.
5. Minute setting: the minute ashes on the display: choose
the desired unit with “”button and conrm with “”
(ON / OFF) button.
6.
Measurement unit setting: the unit “KPa” or “mmHg” ashes on the display:
choose
the desired measurement unit with “”button and conrm with “”
(ON / OFF) button.
Please be noticed, the clock will begin to run from 2016-01-01 01:01, and Unit in
mmHg, if no key is pressed within 20 seconds.
5. Carrying Out a Measurement
5.1 Before the measurement
Avoid eating, smoking as well as all forms of exertion directly before the
measurement. All these factors inuence the measurement result. Try and
nd time to relax by sitting in an armchair in a quite atmosphere for about ten
minutes before the measurement.
Measure always on the same arm (normally left).
Attempt to carry out the measurements regularly at the same time of day, since
the blood-pressure changes during the course of the day.

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M-L size
Air connector
Cu󰀨
5.2 Common sources of error
Note: Comparable blood-pressure measurements always require the same
conditions! These are normally always quiet conditions.
All e󰀨orts by the patient to support the arm can increase the blood-pressure.
Make sure you are in a comfortable, relaxed position and do not activate any of
the muscles in the measurement arm during the measurement. Use a cushion
for support if necessary.
The performance of the automated sphygmomanometer can be a󰀨ected by
extremes of temperature, humidity and altitude.
Avoid compression or restriction of the connection tubing.
A loose cu󰀨 causes false measurement values.

With repeated measurements, blood accumulates in the respective arm, which
can lead to false results. Correctly executed blood-pressure measurements should
therefore rst be repeated after a 5 minute pause or after the arm has been held
up in order to allow the accumulated blood to ow away (after at least 3 minutes).
5.3Fittingthecu󰀨
Insert air connector into air outlet shown
in left photo and please make sure the
tting of the air connector completely and
properly to avoid air leakage.
a) The distance between the edge of cu󰀨
and the elbow should be approx. 2~3cm.
b) Secure the cu󰀨 with the Velcro fastener,
so that it lies comfortably and not too
tight, whereby no space should remain
between the cu󰀨 and the arm.
c) Lay the arm on a table, with the palm
upwards. Support the arm a little with a
rest (cushion), so that the cu󰀨 rests at
about the same height as the heart. Take
care, that the cu󰀨 lies free. Remain so for
2 minutes sitting quietly, before beginning
with the measurement.
d) Let legs uncrossed, feet at on the oor,
back and arm supported.

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5.4 Measuring procedure
After the cu󰀨 has been appropriately positioned, the measurement can begin:
a) Press the ON / OFF button, the pump begins to inate the cu󰀨. In
the display, the increasing cu󰀨-pressure is continually displayed.
b) As the cu󰀨 inates, the monitor automatically determines your
ideal ination level. This monitor detects your blood pressure
and pulse rate during ination. The heartbeat symbol ( )
ashes at every heartbeat.
c) When the measurement has been concluded. The measured
systolic and diastolic blood-pressure values as well as the
pulse frequency are now displayed.
Example (Fig.): Systole 126, Diastole 85, Pulse 78
The measurement results are displayed, until you switch the device o󰀨. If no
button is pressed for 3 minutes, the device switches automatically o󰀨, to save the
batteries.
5.5 Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason
(e.g. the patient feels unwell), the “ON / OFF” power button can be pressed at
any time. The device then immediately lowers the cu󰀨-pressure automatically.
5.6 Memory – storage and recall of the measurements
The blood-pressure monitor automatically stores each of the last 120
measurement values. By pressing the MEMORY button, an average value of the
last 3 measurements as well as the last measurement and the further last 120
measurements (MR119, MR118, …, MR1) can be displayed one after the other.
(MR1: Values of the last measurement) (MR2-MR120: Values of the
measurement before MR1)

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5.7 Memory– cancellation of all measurements
Before you delete all readings stored in the memory, make sure you
will not need refer to the readings at a later date. Keeping a written
record is prudent and may provide additional information for your
doctor’s visit. In order to delete all stored readings, depress the
MEMORY button for at least 5 seconds, the display will show the
symbol “CL” and then release the button. To permanently clear the
memory, press the MEMORY button while “CL” is ashing. To indicate deletion of
stored readings.
6. Appearance of the Pulse Arrhythmia
Indicator for Early Detection
This symbol “ ” indicates that certain pulse irregularities were detected during
the measurement.
In this case, the result may deviate from your normal blood pressure – repeat the
measurement. In most cases, this is no cause for concern. However, if the sym-
bol appears on a regular basis (e.g. several times a week with measurements
taken daily) we advise you to tell your doctor.
Please show your doctor the following explanation:
Information for the doctor on frequent appearance of the Arrhythmia indicator
This instrument is an oscillometric blood pressure monitor that also analyses
pulse frequency during measurement. The instrument is clinically tested. The
arrhythmia symbol is displayed after the measurement, if pulse irregularities
occur during measurement. If the symbol appears more frequently (e.g. several
times per week on measurements performed daily) we recommend the patient to
seek medical advice.
The instrument does not replace a cardiac examination, but serves to detect
pulse irregularities at an early stage.

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7. Error Messages / Malfunctions
If an error occurs during a measurement, the measurement is discontinued and a
corresponding error code is displayed.
Error No. Possible cause(s)
ERR 1 No pulse has been detected.
ERR 2 Unnatural pressure impulses inuence the measurement result. Reason:
The arm was moved during the Measurement (Artefact).
ERR 3 The ination of the cu󰀨 takes too long. The cu󰀨 is not correctly seated.
ERR 5 The measured readings indicated an unacceptable di󰀨erence between
systolic and diastolic pressures. Take other reading following directions
carefully. Contact you doctor if you continue to get unusual readings.
ERR 8 The pressure in the cu󰀨 is too high (over 290 mmHg).
Further Information - The level of blood-pressure is subject to uctuations even
with healthy people. Important thereby is, that comparable measurements always
require the same conditions (Quiet conditions)! If, in spite of observing all these
factors, the uctuations are larger than 15 mmHg, and / or you hear irregular
pulse tones on several occasions, please consult your doctor. For licensing, the
device has been subjected to strict clinical tests, by which the computer program
used to measure the blood-pressure values was tested by experienced specialist
doctors in Germany. The same computer program is used in every individual
device, and has thus also been clinically tested. The manufacture of the devices
takes place according to the terms of the European standard for blood-pressure
measuring devices (see technical data) you must consult your specialist dealer
or chemist if there are technical problems with the blood-pressure instrument.
Never attempt to repair the instrument yourself! Any unauthorized opening of the
instrument invalidates all warrantee claims!

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Other possible malfunctions and their elimination
If problems occur when using the device, the following points should be checked
and if necessary, the corresponding measures are to be taken:
Malfunction Remedy
The display remains empty
when the instrument is
switched on although the
batteries are in place.
1. Check batteries for correct polarity and if necessary insert
correctly.
2.
If the display is unusual, re-insert batteries or exchange them.
The device frequently
fails to measure the blood
pressure values, or the
values measured are too
low (too high).
1. Check the positioning of the cu󰀨.
2. Measure the blood-pressure again in peace and quiet
under observance of the details made under point 5.
Every measurement
produces a di󰀨erent value
although the instrument
functions normally and
the values displayed are
normal
1. Please read the following information and the points
listed under “Common” sources of error. Repeat the
measurement.
Pleasenote:Bloodpressureuctuatescontinuallyso
successive measurements will show some variability.
Blood pressure measured
di󰀨ers from those values
measured by the doctor.
1. Record the daily development of the values and consult
your doctor. Please note: Individuals visiting their doctor
frequently experience anxiety which can result in a
higher reading at the doctor than obtained at home
under resting conditions.
8. Care and Maintenance, Recalibration
a) Do not expose the device to extreme temperatures, humidity, dust or direct
sunlight.
b) The cu󰀨 contains a sensitive air-tight bubble. Handle this carefully and avoid
all types of straining through twisting or buckling.
c) Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar
solvent. Spots on the cu󰀨 can be removed carefully with a damp cloth and
soapsuds. The cu󰀨 must not be washed!
d) Do not drop the instrument or treat it roughly in any way. Avoid strong
vibrations.
e) Never open the device! Otherwise the manufacturer calibration becomes
invalid!

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9. Battery Life
1000 times measurement with 4- size “AA” alkaline Batteries.
10. Safety, Care and Disposal
Safety and protection
This instrument may be used only for the purpose described in this booklet.
The manufacturer cannot be held liable for the damage caused by incorrect
application.
This instrument comprises sensitive components and must be treated with
caution. Observe the storage and operating conditions described in the
“Technical specications” section!
Protect it from water and moisture, extreme temperatures, impact and dropping,
contamination and dust, direct sunlight, heat and cold.
The cu󰀨s are sensitive and must be handled with care.
Only pump up the cu󰀨 once tted.
Do not use the instrument close to strong electromagnetic elds such as mobile
telephones or radio installations.
Do not use the instrument if you think it is damaged or notice anything unusual.
If the instrument is not going to be used for a prolonged period the batteries
should be removed.
 Read the additional safety instructions in the individual sections of this
booklet. Ensure that children do not use the instrument unsupervised:
some parts are small enough to be swallowed.
Must use the recognized accessories, detachable parts and materials, if the
use of other parts or materials can degrade minimum safety.
A warning to remove primary batteries if the instruments is not likely to be used
for sometime.
Instrument care
Clean the instrument only with a soft, dry cloth.
Disposal
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestics waste.

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11. Reference to Standards
Device standard: Device corresponds to the requirements of the European
standard for non-invasive blood- pressure monitor.
Standard
IEC60601-1-6:2010+A1:2013 / EN60601-1-6:2010+A1:2015
IEC60601-1:2005+A1:2012 / EN60601 1:2006+A11:2011+A1:2013+A12:2014
IEC60601-1-2:2014 / EN60601-1-2:2015
IEC / EN60601-1-11:2015
IEC80601-2-30:2009+A1:2013 / EN80601-2-30:2010+A1:2015
The stipulations of the EU-Guidelines 93 / 42 / EEC for Medical Products Class
IIa have been fullled.
12. Remark
Serial number
Class IIa medical device
Unique Device Identication
system
Number of products in one
packaging
Before use, read the instructions.
Electronic instructions for use:
http://www.mediblink.com/f/m520.pdf
Type BF equipment
IP22 Ingress of water
EU Representative
Some electrical and electrical
equipment forbid to abandon and
disposal at will
Manufacturer’s name and address
Inapplicable baby
Cu󰀨 Connector
Warning! Consult accompanying
documents
Product reference number
#Model number
Batch number*
*TheproductiondatecanbereadfromLOTnumber[YYYYMM];rstfourdigitsrepresenttheYearandlast
twodigitsMonthofproduction.Example:LOT202503=March2025

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13.TechnicalSpecications
Model: BP168A
Measurement Procedure: Oscillometric, corresponding to Korotko󰀨 method:
Phase I: systolic, Phase V: diastolic
Display: Digital display
Measuring range: Pressure: 30 to 280 mmHg (in 1 mmHg increment)
Pulse: 40 to 199 beat / minute
Static accuracy: Pressure: ± 3 mmHg
Pulse: ± 5 % of reading
Measuring resolution: 1 mmHg
Ination: Automatic ination by internal pump
Memory function: 2 x 120 memories for 2 users (SYS, DIA, Pulse)
Decompression: Constant exhaust valve system
Power source 1 (Battery): 4- size “AA” alkaline Batteries
Power source 2 (Adapter): Input : 100-240V ~ 50 / 60 Hz 0.2A
Output : 6V – 0.6A
Operation temperature: 5 ~ 40°C / 41 ~ 104°F
Operation humidity: 15 % ~ 80 % RH maximum
Storage temperature: -20 ~ +55°C / -4 ~ +131°F
Storage humidity: 10 % ~ 95 % RH maximum
Dimensions: 120 × 80 × 38 ±1.0 mm
Weight: 510 g ± 5g (including batteries and cu󰀨)
Cu󰀨pressuredisplayrange: 0 ~ 290 mmHg / 0 ~ 38.7 kPa
Electrical shock protection: Internal power unit
Safetyclassications: Type BF equipment
Mode of operation: Continuous operation
Protection against ingress of
water: IP22
Accessories: M-L size Cu󰀨, 4 “AA” batteries, instruction manual

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14. Manufacturer’s Declaration
M520 with MDI is intended for use in the electromagnetic environment specied
below. The customer or the user of M520 with MDI should assure that it is used
in such an environment.
Electromagnetic Emissions: (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment
RF emission CISPR 11 Group 1
M520 with MDI uses RF energy only for internal functions. Therefore, this RF
emission is extremely weak and there is little chance of it creating any kind of
interference whatsoever with nearby electronic equipment.
RF emissions CISPR 11 Class B M520 with MDI is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Not applicable
Voltage uctuations / icker IEC 61000-3-3 Not applicable
Electromagnetic Immunity: (IEC60601-1-2)
Immunity test IEC60601-1-2 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30 %
Electric fast transient / burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input / output lines
Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV di󰀨erential mode
±2 kV common mode
Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
<5 % U
T
(95 % dip in U
T
) for 0.5 cycle
40 % U
T
(60 % dip in U
T
) for 5 cycles
70 % U
T
(30 % dip in U
T
) for 25 cycles
<5 % U
T
(95 % dip in U
T
) for 5 sec.
Not applicable Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the upper arm style requires continued
operation during power mains interruptions, it is
recommended that M520 with MDI be powered
from an uninterruptible power supply or a battery.
Power frequency (50 / 60 Hz)
magnetic eld IEC 61000-4-8
3 A / m Not applicable Not applicable
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Immunity test IEC60601-1-2 test level IEC60601-1-2
test level Electromagnetic environment – guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms 150 kHz to 80 MHz
80% AM (2Hz)
3 Vrms 80 MHz to 2.5 GHz
80% AM (2Hz)
3 Vrms
3 V / m
Portable and mobile RF communications equipment should be
used no closer to any part of M520 with MDI, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommend separation distance
3 V
d = 1.2×p
1 / 2
80 Mhz do 800 MHz
d = 2.3×p
1 / 2
MHz do 2.5 GHz
Where Pis the maximum output power rating of the transmitter in
watts (W) according to he transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from xed RF transmitters as determined by an
electromagnetic site survey
a
, should be less than the compliance
level in each frequency range
b
. Interference may occur in the vicinity
of equipment marked with the following symbol:

20
EN
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by absorption and reection from structures, objects,
and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to xed RF transmitters, an electromagnetic site survey should be considered. If the measuredeld strength in the location in which the M520
with MDI is used exceeds the applicable RF compliance level above, M520 with MDI should be observed to verify normal operation. Ifabnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating M520 with MDI.
b
Over the frequency range 150 kHz to 80MHz, eld strengths should be less than 3 V / m.
Recommended Separation Distances:
Recommended separation distance between portable and mobile RF communications equipment and M520 with MDI.
M520 with MDI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of M520 with MDI can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and M520 with MDI as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
d = 1.2×p1 / 2 80 to 800 MHz d = 1.2×p1 / 2 800 MHz to 2.5 GHz d = 2.3×p1 / 2
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by absorption and reection from structures,
objects and people.
Manufacturer Information:
Shenzhen Combei Technology Co, Ltd.
11-5B, No.105, Huanguan South Road,
Dahe Community Guanlan, Longhua District,
ShenZhen, Guangdong, China
MedNet EC-REP GmbH
Borkstrasse 10
48163 Münster
Germany
Manufactured for
(Importer for EU & Distributor):
Mediblink d.o.o.
Gubčeva cesta 19
8210 Trebnje
Slovenia
[email protected]
www.mediblink.com
Instructions for use, version No:
M520-2019-V01
Issue date:
17.12.2019
Date of last change:
13.07.2022