Elamed EASYTON User manual

1
EASYTON Tonometer is covered by Russian Federaon’s Patent No. 2335234.
The device is compliant with all the security requirements provided by
IEC 60601-1:2005 and IEC 60601-1-2:2007-03 internaonal standards.
The tonometer conforms with the European Economic Community Direcve 93/42/EEC.
Das EASYTON-Tonometer ist patentrechtlich geschützt (Patent der RF No. 2335234).
Das Tonometer entspricht allen Sicherheitsforderungen im Sinne internaonaler
Normen IEC 60601-1:2005 und IEC 60601-1-2:2007-03. Das Tonometer entspricht
den Anforderungen der europäischen Richtlinie für Medizinprodukte 93/42/EEC.
Le tonomètre EASYTON est protégé par le brevet de la Russie №2335234.
Le tonomètre est conforme à toutes les normes de sécurité prévues par les standards
internaonaux IEC 60601-1:2005 et IEC 60601-1-2:2007-03. Le tonomètre est conforme
à la direcve de la Communauté économique européenne 93/42/EEC.
Il tonometro EASYTON è proteo dal breveo della Russia n. 2335234.
Il tonometro soddisfa tui requisidi sicurezza previsdalle norme internazionali
IEC 60601-1:2005 e IEC 60601-1-2:2007-03. Il tonometro soddisfa i requisidella
direva 93/42/CEE della Comunità Economica Europea.
El Tonómetro EASYTON está protegido por la Patente №2335234 de Rusia.
El Tonómetro cumple todos los requerimientos de seguridad previstos en los Estándares
Internacionales IEC 60601-1:2005 y IEC 60601-1-2:2007-03. El Tonómetro cumple todos
los requerimientos de la Direcva 93/42/EEC de la Comunidad Económica Europea.
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English
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Deutsch
42
Française
62
Italien
82
Español

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1. DESCRIPTION AND DESIGN FEATURES.
OPERATING PRINCIPLE
2. PREPARATION FOR OPERATION
2.1. Baery Installaon and Replacement
2.2. Funconality Checkup Using the Tester
2.3. Disinfecon
3. DEVICE APPLICATION PROCEDURE
3.1. Tonometer Measuring Mode Setup
3.2. Pre-Measurement Steps
3.3. Measuring Procedure
3.4. Requirements for Accurate Measuring Results
4. POSSIBLE ERRORS AND TROUBLESHOOTING
5. MAINTENANCE SERVICE AND MINOR REPAIRS
6. SPECIFICATIONS
7. MARKING
8. STORAGE AND TRANSPORTATION
9. MANUFACTURER’S WARRANTY
10. ACCEPTANCE CERTIFICATE
11. APPENDIX A
TABLE OF CONTENTS Thank you for purchasing EASYTON transpalpebral digital
tonometer for intraocular pressure measurement (below
referred to as the Tonometer).
The Tonometer is intended for measuring true and tonometric
intraocular pressure (IOP) through a closed eyelid, both on
children and adults.
The Tonometer is a medical measuring instrument which is
approved for usage both at healthcare facilities and in home
conditions as an individual means of IOP control.
Please make sure to carefully study the Operating Manual
before starting to use the Tonometer. Please consult your
attending doctor regarding the values of intraocular pressure
which are specific to you personally.
Tonometer usage is contraindicated in the following cases:
• pathological condions of the upper eyelid
(inflammatory condions, scars, eyelid deformies);
• evident scleral and/or conjuncval pathology in the area of
the Tonometer rod’s acon.
Use the QR code to watch the training video

3
ENG
• Make sure to examine the Tonometer body and
rod for presence of mechanical damages. Using the
Tonometer if any of these damages have been detected
is PROHIBITED.
• Protect the Tonometer from shock and impact. When
carrying the Tonometer around, put it into the plasc
case, with the protecve cap over its working part.
• Avoid penetraon of moisture inside the Tonometer.
In case if a liquid did get inside the device, let it dry at
room temperature for at least 4 hours before using it
again and check its funconality on the tester.
• Avoid high temperatures.
• Avoid thermal shock. This may cause malfunconing of
the Tonometer.
• Do not use the Tonometer in the shower and bathroom.
KEY SAFETY TIPS
!
!
Attention! An exclamation point symbol displayed in the
Tonometer window, accompanied by continuous beeping
sound, is a signal of its inoperable condition and of
excessive pressure load of the rod upon the eyelid, which
may cause painful sensations for a patient.
1. DESCRIPTION AND DESIGN FEATURES.
OPERATING PRINCIPLE
The Tonometer is intended for measuring intraocular pressure
for adults and children.
The Tonometer can measure IOP in two modes:
• tonometric IOP measuring mode (Maklakov’s scale)
• true IOP measuring mode (Goldmann scale)
IOP measurement is taken through closed eyelid, which pre-
vents any contact with sclera or cornea, and does not require
any anaesthesia.
The Tonometer’s operang principle is based on measuring
intraocular pressure by means of registering the frequency of
forced vibraons of the eye membranes (sclera and cornea)
under the acon of the Tonometer’s vibrator rod.
During the measuring process, the rod is placed onto the eyelid,
pressed against it with the weight of about 10 g, and fixated
over the eye sclera or cornea. The vibraons are set offby a
short electromagnec pulse affecng the vibrator rod. The rod
moon is transmied on to the eye through eyelid in the form
of a momentary impact which incites forced vibraons of the
eye membranes.
The period of vibraons is read by the Tonometer and used to
calculate the IOP value. The results are shown on the display.

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Key Design Features
A. Tonometer body
B. On/Offbuon
C. Display window
D. Vibrator rod
E. Buffer ring
F. Protecve cap
G. Baery case cover
H. Baeries
I. Case box
J. Tester
F D E A B C H G
I
J
Display Symbols
K. Baery level indicaon
L. Current IOP measurement mode:
«M» = «tonometric» (Maklakov’s scale);
«G» = «true» (Goldmann scale)
M. Ready-for-operaon indicaon
N. Measured IOP reading
O. Square frame around the reading value =
unstable posioning of the Tonometer, or the
paent’s eyelid or eye.
M N O
K L K L K L

5
ENG
Complete Set
• EASYTON Tonometer 1
• Built-in tester case 1
• 1.5 V battery standard size ААА, R03 2
• Operang Manual 1
• Retail packaging 1
Important Facts on Intraocular Pressure
Intraocular pressure measurement is a method of
eye health diagnostics used in ophthalmology.
Intraocular pressure generally has 3 basic condi-
tions:
• normal
• hypertension (high pressure)
• hypotension (hypotony)
Stascally, the normal range of true IOP (Р0) is
within 10 to 21 mmHg, while the tonometric IOP
level (Pt) ranges from 12 to 25 mmHg. Regardless
of its basic condion, IOP may be irregular or may
change in the course of the day. The normal value
may vary in the range of 2-2.5 mmHg.
2. PREPARATION FOR OPERATION
2.1. Battery Installation and Replacement
The current baery status is marked with the power level indica-
tor in the top lecorner of the Tonometer display.
Baeries fully
charged Baeries parally
discharged Low baery
If the baƩeries are discharged, the Tonometer will not switch on.
Batteries are to be replaced with the Tonometer switched off.
If you plan to use the device again only in a few months’ Ɵme,
make sure to take the baƩeries out.

6
Turn the Tonometer over so
that its front panel is facing
downwards.
Slide the battery case cover
in the direction of the arrow
marked on it.
Insert / replace the two AAA
batteries in such a way so
that their «+» (positive) and
«–» (negative) contacts would
match the polarities marked
inside the battery case.
Put the battery case cover
back on.
press your finger
against the housing
slide the cover in
as far as it can go
Attention! Immediately after inserting the batteries, switch
the Tonometer on and offby shortly pressing the On/Off
button.
This is done to check proper installation of the batteries, and
the Tonometer is set into the micro-consumption mode.
2.2. Functionality Checkup Using the Tester
The Tonometer funconality is to be checked on the tester at
least once a week, as well as in the following cases:
• aer long idle periods
• aer dropping the device
• aer changing the baeries
• in any other cases when you doubt if the Tonometer
works properly
To check the Tonometer functionality on the tester, do as
follows:
Open the Tonometer case.
Take the device out and put the opened case with the
tester on a table.
Position the Tonometer with the rod up and take the
protective cap off.
Shortly press the On/Offbutton to switch the
Tonometer on.
A moving arrow displayed in the Tonometer window
indicates its readiness for operation.
Hold the Tonometer with your fingers by the cylinder-
shaped part of its housing.
!
1
2
3
41
2
3
4
5
6

7
ENG
Place the Tonometer with
the measuring rod down and
position its housing so as to
be able to see the readings
on the display.
Position the Tonometer
vertically above the tester.
The heel of the hand holding
the device should rest
against the table surface.
Keeping the heel of the hand fixed
on the table, insert the device rod
down into the center of the tester
pinhole. Dip the Tonometer buffer
ring as far down as it can go into the
circular groove of the tester. The lower
surface of the Tonometer ring should
be aligned with the circular groove
surface as much as possible.
At this point, the measuring mode is
actuated, which is perceived by the
hand as light vibration. Meanwhile,
Attention! Upright positioning of the Tonometer (allowed
deviation from vertical axis should not exceed 15 degrees)
must be preserved during all measurements.
!
ready-for-
operaon
measurement
mode
measurement
completed
7
8
9
the pressure value is displayed in the
Tonometer window.
Keeping the device fixed in this position,
keep an eye on the digital value of the
pressure displayed in the Tonometer
window. The measuring mode will
continue until the device is lifted away
from the tester. The digital reading on
the display should not diverge from
the one listed in the «Specifications»
section of this Manual by more than
two units.
Raise the Tonometer above the
tester. The measuring mode is thus
completed, and the measured value is
captured on the display.
The measuring can be repeated
for as many times as needed, following
Clauses 9, 10, and 11 of this section.
Deactivate the Tonometer by shortly
pressing the On/Offbutton.
Put on the protective cap, with the
Tonometer rod turned upwards, and
put the device into its case.
10
11
12
13
14

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2.3. Disinfection
Please disinfect the Tonometer while it is switched off.
Disinfecon of the buffer ring and Tonometer rod should be per-
formed before and aer each new paent’s IOP measurement.
To perform the disinfecon procedure, do as follows:
1. Holding the Tonometer
with the rod down, treat the
buffer ring and the lower
part of the rod with a sterile
cloth moistened with a
disinfectant solution based
on ethyl alcohol, which does
not enter into reaction with
the metal.
2. Wipe the buffer ring and
the lower part of the rod
with a dry sterile cloth.
Disinfection of the outer
surfaces of the Tonometer
body (others than the
rod and the buffer ring)
is performed as may be
needed, using 3% hydrogen
peroxide solution mixed with
0.5% solution of a household
detergent.
After disinfection, wipe
the outer surfaces of the
indicator housing with a dry
sterile cloth.
The process of disinfection of the tonometer was validated
and was recognized as acceptable by the results of tests in
the mycobiological laboratory.
Attention! Avoid penetration of the disinfectant solution
inside the Tonometer.
!
3. DEVICE APPLICATION PROCEDURE
3.1. Tonometer Measuring Mode Setup
EASYTON Tonometer is provided with two opons for IOP
measuring.
M
(tonometric) IOP:
Maklakov’s scale
with a weight
load of 10 g
G
(true) IOP:
Goldmann scale
The «M» or «G» symbol
in the top right secon of
the display indicates the
current measurement
mode.
The Goldmann IOP scale
is pre-set by the Manu-
facturer by default. The
previously set measuring
mode remains acve
unl the next mode
change.
Deacvaon of power
supply does not cause
change of the mode set
earlier.

9
ENG
Changing of the measuring mode can be done at any me.
To change it, do the following:
Briefly press the On/Offbutton to
switch the Tonometer on.
When a moving arrow appears on the
Tonometer display, press the On/Off
button and hold it down for about 5
seconds until the mode symbol on the
display changes automatically.
Shut the Tonometer down by releasing
the On/Offbutton.
Re-activate the Tonometer and make
sure that the previously changed
mode is still on.
1
2
3
4Hold the buon
down for 5 seconds
3.2. Pre-Measurement Steps
Take the Tonometer out of its case.
Position the Tonometer with the rod
up and take the protective cap off.
Disinfect the Tonometer (see Cl. 2.3).
Shortly press the On/Offbutton to
switch the Tonometer on. When
activated, the Tonometer produces a
beeping sound.
Check for presence of a moving
arrow on the Tonometer display,
which indicates its readiness for
measuring.
Check the Tonometer functionality
using the tester (see Cl. 2.2).
1
2
3
4
5
6

10
The Tonometer can
take measurements
on any available spot
of the sclera through
the eyelid.
There are, however, certain spots which are
recommended for measuring because of their
convenience both for the doctor and the
paent.
3.3. Measuring Procedure
•
•
•
Т
Hold the activated Tono-
meter with your fingers by
the cylinder-shaped part
of its housing.
Place the device with its
rod facing downwards.
Turn the Tonometer so
as to be able to see the
readings on the display.
Stand at the patient’s side
slightly behind them.
Attention! IOP measurements are made while the patient
is seated. It is essential that the patient’s head is tilted
back, as close to horizontal
position as possible.
!
• The patient’s gaze must be
fixed at a test object (for
instance, their own hand),
their eye gaze line making
up an angle of 45° from
upright direction.
•
•
•
The heel of the hand holding the Tonometer should rest
against the patient’s forehead. The smoothness and
preciseness of movements required for the measuring
process is achieved by resting the hand against the
patient’s head (forehead), as well as trained through
continuous usage.
Stretch the upper eyelid with a
finger of your free hand in a way
to ensure alignment of the upper
eyelid edge with the corneal edge.
Fixate and hold the eyelid in this
position, without pressing on the
eyeball.
Place the Tonometer rod on the
eyelid in the scleral area, 2-3 mm
away from the eyelid edge.

11
ENG
• Holding the Tonometer vertically
down, smoothly lower it down
by 2-3 mm. At this point, dynamic
force is actuated, which is
perceived as light vibration.
During the measuring process,
make sure that the buffer ring does
not touch the eyelid, but remains
2-3 mm above the eyelid surface.
Avoid slipping of the eyelid onto the cornea while
taking the measurement.
Attention! When the Tonometer is lowered too far down,
it produces a continuous single-tone beep, which stops
automatically when the device is raised high enough for
measuring.
!
• 1 or 2 seconds after lowering the Tonometer down, it
produces a beep indicating that the measurement is
completed, and the measured IOP value is displayed in
its window. The measuring process will continue until
the device is lifted away.
To end the process, lift the device up. At the moment
when the measurement is taken, the device produces
another beep, and the measured IOP value is displayed
in the window.
In case if the sound signal didn’t come offat all or came
offwith a delay of more than 3 seconds, the measuring
needs to be repeated.
Deactivate the Tonometer by shortly pressing the On/
Offbutton. Put the protective cap back on, with the
Tonometer rod up, and put the device back into its case.
•
•
Attention! If the positioning of the
Tonometer, the patient’s eyelid or eye, is
unstable during the measuring process,
the resulting reading may appear on the
display in a square frame. If this happens,
the measurement needs to be re-taken.
!
3.4. Requirements for Accurate Measuring Results
To obtain the most accurate IOP measurement results, the following
conditions must be observed:
• The Tonometer body should be posioned strictly upright.
Try to preserve the angular deviaon from vercal axis at 15 degrees
max., especially at the inial stage of the device applicaon.
• The Tonometer rod should be posioned at right angle against
the eye surface. To achieve that, align the Tonometer rod axis with
the geometric center of the eyeball.
• Smoothness and preciseness of movements during the measur-
ing process. These can easily be achieved when the hand holding
the Tonometer is resng against the paent’s head (forehead).

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4. POSSIBLE ERRORS AND TROUBLESHOOTING
Problem Possible cause Troubleshooting method
The Tonometer does not switch on The batteries are dead Replace the batteries
The batteries are seated
incorrectly Insert the batteries with due regard to the
polarity markings (+ / -)
The contact of the batteries is
unstable Replace the batteries. Clear the contacts of the
battery holders using an erasing rubber
The On/Off button is broken Repair at a maintenance service facility
The Tonometer itself is broken Repair at a maintenance service facility
The Tonometer readings obtained with the tester
deviate from the values specified in the Manual by
more than 2 units
The Tonometer is de-calibrated Calibration at a maintenance service facility
The Tonometer is broken Repair at a maintenance service facility
After the measurement is completed (and the
Tonometer lifted up), the vibration action does not
stop or stops only after a notable delay (more than a
second)
The rod motion sensor is de-
calibrated Calibration at a maintenance service facility
When switching the Tonometer on, it does not display
any indications, and an alarm signal is produced The Tonometer display is broken Repair at a maintenance service facility
The batteries run low too soon (in less than 30 days) Excessive power consumption Repair at a maintenance service facility

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ENG
5. MAINTENANCE SERVICE AND MINOR REPAIRS
Maintenance Procedure
Procedure Frequency
1. Routine inspection At least once a day
2. Cleaning from dust and dirt As may be necessary
3. Functionality checkup Before each IOP
measurement procedure
4. Battery changing When the symbol « »
appears on the display
Minor Repairs
During routine inspection, make
sure to check the integrity of the
Tonometer body and to check
for mechanical damages of the
vibrator rod.
The Tonometer functionality
checkup is to be done as
described in the clause titled
«Tonometer Functionality
Checkup Using the Tester».
Do not attempt any
repairs by yourselves.
Should you have any
doubts regarding
correct operation of the
device, please contact
the Manufacturer or its
representative office.
!
Minor repairs of the Tonometer are provided by the
Manufacturer or its representative facility, after a technical
inspection of the malfunction nature and degree has been
performed by the Manufacturer’s experts.
The following may indicate presence of a malfunction:
• mechanical damages of the Tonometer housing and
(or) vibrator rod;
• divergence of the Tonometer readings obtained with
the tester from the ones listed in the «Specifications»
section;
• absence of readings on the display despite presence of
the sound of the rod vibration specific for measuring;
• absence of the power level indication symbols.
During minor repairs, troubleshooting is done by
replacement or recovery of the parts and elements;
adjustment of the Tonometer is conducted to ensure its
compliance with the parameters listed in this Manual. Upon
completion of the repairs, the Tonometer is returned to the
user, and its warranty period is renewed starting from the
date of return.
Safety Measures
No special precautions are required while conducting the
repairs.

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6. SPECIFICATIONS
Parameter Parameter value
Device Transpalpebral digital
tonometer for
intraocular pressure
measurement
Model EASYTON
IOP readings range
(Goldmann scale), mmHg 7-50
(Maklakov’s scale), mmHg 15-53
Absolute permissible error limits
for IOP measurements
(Goldmann), mmHg, within the range of:
7-23 mmHg ±2
above 23 mmHg ±5
(Maklakov), mmHg, within the range of:
15-28 mmHg ±2
above 28 mmHg ±5
Measurement modes:
IOP: Goldmann scale G (True)
IOP: Maklakov’s scale M (Ton)
IOP measurement time, sec, max 2
Power consumption during
measurement, mA, max 100
Power supply:
No. of elements and voltage, V 2 × 1.5,
standard size ААА, R03
Parameter Parameter value
Display LCD
Data output Display window
Overall dimensions
(L×H×W) mm, max 173 × 27 × 21
Weight, g, max 88, incl. batteries
Operating conditions:
operating temperatures range, °Сfrom +10 to +35
relative air humidity,%, max 80
atmospheric pressure, mmHg 630-800
Mean service life, no less than 5 years
Tonometer readings obtained with the tester in the Goldmann IOP
measurement mode ______________________ +/-2 mmHg.
(to be filled in at device acceptance)

15
ENG
7. MARKING
The Tonometer is marked with the following symbols:
Refer to the operang manual
The Tonometer’s working part is the sufficiently protected
against electric shock
The product is licensed with Approval Cerficate
of Measuring Instruments
Compliant with CU TR 020/2011 Technical Regulaons of
the Customs Union
Compliant with MDD 93/42/ЕЕС
Safety and effectiveness of the tonometer in the intended
environment of use is supported by testing that was
conducted in accordance with the following standards:
EN ISO 10993.1-2011 «Medical products. Assessment of
medical products biological effect. Part 1. Assessment and
investigation».
EN 60601-1-2006 «Electrical medical products. Part 1. Safety
general requirements taking into account of basic functional
characteristics».
EN 60601-1-2 «Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
compatibility – Requirements and tests».
ISO 8612 Second edition 2009 Ophthalmic instruments.
Tonometers.
During pre-market testing process the comparability testing
to a Goldmanntype reference tonometer was performed
on 132 eyes and satisfied results was reached. The resulting
Pearson correlation coefficient is 97%. This indicates the
high accuracy of the EASYTON tonometer compared to the
Goldmann tonometer.
During the bench tests, pressure measurements were
carried out using certified standard eyes models. As a result
of the tests, the required accuracy and repeatability of the
measurements were confirmed.

16
8. STORAGE AND TRANSPORTATION
The Tonometer may
be stored in a closed
non-heated room at a
temperature from -50 °С
to +40 °Сand relative air
humidity of up to 98% (at a
temperature of + 25 °С).
The device can be transported
by all covered vehicles in
microclimatic regionswith a
moderately cold climate at
ambient air temperatures
from -50 °Сto +50 °С.
Attention! After a long storage or transportation at
temperatures below +10 °C, keep the Tonometer in a room
at a temperature from +10 to +35 °C for at least 4 hours.
!
9. MANUFACTURER’S WARRANTY
The Manufacturer hereby guarantees that the quality of
the Tonometer conforms to the requirements stated in the
Operating Manual, provided that the conditions of proper
storage, transportation, and usage are met by the Customer.
Guaranteed service life (warranty period) is 24 months from
the date of sale.
Within the warranty period, the Manufacturer shall repair
or replace the defective Tonometer free of charge, upon
presentation of the warranty service coupon.
Warranty provisions
The warranty is only valid if the Customer has a correctly filled-
in warranty coupon, with the factory serial number and date of
sale indicated, and a vivid stamp of the trading company.
The warranty does not cover the following cases:
• if the Tonometer bears traces of outside interference or repair
attempts by non-authorized servicing companies;
• if unauthorized changes into the design or construction of the
Tonometer have been detected;
• if the Tonometer has any mechanical damages;
• if the Tonometer has been damaged as a result of penetration
of foreign objects, substances or liquids.
The batteries are not covered by this warranty.
When the service life or operational life cycle of the
batteries expires, the Customer is to replace them of their
own accord.
The guaranteed shelf life is 24 months.
Please send a faulty Tonometer for repairs, together with
the Operating Manual and an enclosed explanatory note, to
the Manufacturer’s representative at the following address:
For any quesons on the device quality and maintenance service,
please contact the Manufacturer’s representave.

17
ENG
10. ACCEPTANCE CERTIFICATE
EASYTON transpalpebral digital tonometer for intraocular
pressure measurement factory serial number
is manufactured and accepted in compliance with the
technical specification GIKS.941329.102 TS and is hereby
validated as ready-for-service.
Software version No. GIKS.17-0103.3.
Date of producon Stamp
EASYTON transpalpebral digital tonometer for intraocular
pressure measurement is packed according to the require-
ments specified in the design documentaon.
Date of packing
Packed by Stamp
(signature of a person responsible for acceptance)
Manufacturer’s Address:
«Yelatma Instrument Making Enterprise», JSC
391351, 25 Yanina st., Yelatma, Kasimov district, Ryazan region, Russia
Tel/fax: +7 (4912) 293-418, +7 (49131) 2-04-57
WARRANTY SHEET
for repairs (replacement) within the warranty period EASYTON
transpalpebral digital tonometer for intraocular pressure measurement
Manufacturing date No.
Purchased
Put in operation
Accepted for warranty service by the service center
Date City
Released after repairs
Stamp
Signature of the Head of Repair Center
Signature of the Owner
The present warranty sheet should be sent to the Manufacturer and serves as
the basis for the invoice to reimburse repair costs within warranty period.
(to be filled in by the trading organization)
(date, signature)
(date, signature)
(signature)
(signature)

18
11. APPENDIX A
Manufacturer's manual and declaration – electromagnetic emission
These devices are intended for use in the electromagnec environment specified below. The customer or the user of the device should ensure its use in the specified
electromagnec environment.
Electromagnetic
emissions test
Compliance Electromagnetic environment – instructions
Radio-interferences according to Special Internaonal
Commiee for Radio-Electronic
Interferences 11
Group 1 The device uses radio-frequency energy only to perform internal functions. The emission
level of the radio frequency interference is low and might not lead to disturbances in the
functioning of the electronic equipment located close to it
Radio-interferences according to Special Internaonal
Commiee for Radio-Electronic
Interferences 11
B Classes The device is suitable for use in all the locations, including residential buildings and
buildings directly connected to a distribution network that supplies residential buildings
The harmonic current components
of IEC 61000-3-2
Not applied
Table 1

19
ENG
Manufacturer’s manual and declaration – interference resistance
These devices are intended for use in the electromagnec environment specified below. The customer or the user of the device should ensure its use in the specified
electromagnec environment.
Interference resistance test The test level according to IEC 60601 Compliance level Electromagnetic environment – instructions
Electrostac discharge (ESD)
according to IEC 61000-4-2
±6 kV – contact discharge
±8 kV – air discharge
Complies The floor in the facility must be covered with wood, concrete
or ceramic tiles. If the floor is covered with synthetic material,
relative humidity must be minimum 30%
Electrical fast transient/burst
according to IEC 61000-4-4
±2 kV – for powersupply lines
±1 kV – for input-output lines
Not applied Power quality in mains in accordance with the typical
conditions of a commercial or hospital environment
High energy
microsecond pulse interferences
according to IEC 61000-4-5
±1 kV when applying «wire-to-wire»
interference
±2 kV when applying «wire-to-ground»
interference
Not applied Power quality in mains must be provided in accordance
with the typical conditions of the commercial or hospital
environment
Voltage dips, average interrup-
ons and voltage fluctuaons
in the input power lines
according to IEC 61000-4-11
<5% UH(voltage dip>95% UH)
during 0.5 of period
40% UH(voltage dip 60% UH)
during 5 periods
70% UH(voltage dip 30% UH)
during 25 periods
<5% UH(voltage dip >95% UH) during 5 s
Not applied Power quality in mains in accordance with the typical
conditions of a commercial or hospital environment If the
user of the device needs to provide seamless operation in the
conditions of possible interruptions of the line voltage, it is
recommended to power the device from an uninterruptive
power supply or battery
Power frequency magnec field
(50/60 Hz) according
to IEC 61000-4-8
3 A/m Complies The levels of power frequency magnetic field must be provided
in accordance with the typical conditions of the commercial or
hospital environment
Note: UH– is the voltage level of the mains unl test exposure is applied.
Table 2

20
Manufacturer’s manual and declaration – interference resistance
These devices are intended for use in the electromagnec environment specified below. The customer or the user of the device should ensure its use in the specified
electromagnec environment.
Interference resistance test The test level
according to IEC 60601
Compliance
level
Electromagnetic environment – instructions
Conducted disturbances
induced by RF fields according
to IEC 61000-4-6
Radio-frequency electromag-
nec field according
to IEC 61000-4-3
3 V (root-mean-square)
in-band from 150 kHz to
80 MHz
3 V/m in-band from 80 MHz
to 2.5 GHz
3 V
3, V/m
The distance between the mobile radiotelephone communicaon systems used and
any element of the device, including the cables, should not be less than the recom-
mended separaon distance which is calculated in accordance with the expressions
below with reference to the frequency of the transmier.
Recommended separation distance:
d = 1,2 P
d = 1,2 P (from 80 to 800 MHz);
d = 2,3 P (from 800 MHz to 2.5 GHz).
Where d is the recommended separation distance, m b);
P is the nominal maximum transmitter output power, W, as specified by the
manufacturer.
The field density in the propagation of radio waves from stationary radio transmitters,
according to the results of observations of the electromagnetic situation a), should
be lower than the level of correspondence in each frequency band b). The effect of
interference may occur near the equipment marked with the symbol
Table 3
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