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POWER LED LIGHT SOURCE FOR ENDOSCOPY
WLS ED300
0
OPERATING MANUAL
Rev. 07 26/05/2021
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CONTENTS
CONTENTS ...................................................................................................................................................... 1
MANUFACTURER IDENTIFICATION ...................................................................................................... 3
PRODUCT IDENTIFICATION ..................................................................................................................... 4
SYMBOL MEANING ....................................................................................................................................... 5
PRODUCT CLASSIFICATION ..................................................................................................................... 7
According to IEC 60601-1: Class II BF ......................................................................................................................... 7
PHOTOBIOLOGICAL RISK CLASS OF THE DEVICE .......................................................................... 7
CAUTIONS ....................................................................................................................................................... 8
USE DESTINATION .................................................................................................................................... 10
EQUIPMENT PLACEMENT ..................................................................................................................................... 10
ENVIROMENTAL COMPLIANCE .......................................................................................................................... 10
OPERATOR COMPLIANCE .................................................................................................................................... 11
KIND OF FUNCTIONNING .................................................................................................................................... 11
FUNCTIONING FAULTS ......................................................................................................................................... 11
COUNTER EFFECTS ................................................................................................................................................ 12
WARNING, POSSIBLE UNDESIRED EFFECTS ............................................................................................... 12
1
DESCRIPTION OF INSTALLATION AND/OR ASSEMBLING PROCEDURE ............................... 13
ENVIRONMENT COMPLIANCE ............................................................................................................................ 13
ACTIONS TO BE EXECUTED BEFORE SWITCHING THE SYSTEM ON .................................................. 13
FIRST ACTIONS TO BE EXECUTED .................................................................................................................. 14
EMERGENCY SIGNAL AND WARNING ............................................................................................................. 14
ACTIONS TO BE EXECUTED AFTER READING THE MESSAGES: .......................................................... 15
PERIODICAL START UP ............................................................................................................................... 16
MANUFACTURER RESPONSIBILITIES ................................................................................................. 17
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USE INDICATIONS..................................................................................................................................... 18
GENERAL DESCRIPTION ...................................................................................................................................... 18
CONTROLS DESCRIPTION ...................................................................................................................... 19
FORE PANEL MASTER STATION ........................................................................................................................ 19
CLEANING ED300 ...................................................................................................................................... 20
TECHNICAL FEATURES............................................................................................................................. 21
FAULTS RESEARCH ................................................................................................................................... 22
THE EQUIPMENT DOES NOT START ................................................................................................................ 22
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1. GUIDE TABLES AND MANUFACTURER'S DECLARATION ................................................. 23
TECHNICAL ASSISTANCE SERVICE .................................................................................................... 26
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MANUFACTURER IDENTIFICATION
MEDI-CARE SOLUTIONS S.r.l.
Manufacturer:
Via della Zecca 1 , 40125 Bologna
VAT NUMBER IT03390661209
Web site: www.euroclinic.it
Facility:
Via P. Nenni 3 40026 Imola (BO)
Phone ++39 0542 642046
Fax ++39 0542 642355
e-mail: info@euroclinic.it
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PRODUCT IDENTIFICATION
1. 12V DC Power supply
2. Led Handpiece complete with cable
4
3. Power supply control box
4. Operating manual
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SYMBOL MEANING
Symbol indicating classification of type "B" equipment
Class I, II or III device, or device equipped with an internal electrical source, having a degree
of protection against direct and indirect contacts with particular regard to:
- the permissible leakage currents
- The reliability of the ground contact.
This symbol indicates: FOR CLARIFICATION, SEE THE ATTACHED DOCUMENTATION
This symbol indicates:
WARNING! CONSULT THE ATTACHED DOCUMENTATION BEFORE USING THE MD
This Symbol indicates a general warning (read this user manual carefully)
This Symbol indicates a Class II device
This Symbol indicates: Direct Current
Disposal symbol according to regulations
Symbol indicating that the device is a Medical Device (following 2017/745 EU Rule)
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DISPOSAL
The symbol of crossed out garbage bin (on the back of the equipment) indicates that the
product at the end of its working life must be collected separately from other garbage. This
refers to the following law:
art. 13 of D.L: 25 /07/2005, n.151: “Implementation of the regulations 2002/95/CE,
2002/96/CE and 2003/108/CE, about decrease of dangerous substances on electric and
electronic equipments” and moreover it refers to garbage disposal.
The separate collection of rubbish of this equipment (felt into disuse) must be arranged and
coordinated by the manufacturer. When the user wants to throw away the equipment, he will
contact the Manufacturer Company that will indicate all procedures to follow for the disused
equipment separate collection of rubbish.
Therefore, the appropriate separate collection of rubbish, aimed to actuate afterwards disused
equipment recycling, treatment and to ambient garbage disposal, contributes to avoid possible
bad effects on the environment and on the health. In addition, these procedures raise the
reemployment and/or the recycling of the materials of which the equipment is composed.
The unauthorized garbage disposal, on the part of the holder, requires administrative law
sanctions application.
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PRODUCT CLASSIFICATION
According to IEC 60601-1: Class I BF
7
PHOTOBIOLOGICAL RISK CLASS OF THE DEVICE
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8
CAUTIONS
1. Do not install the machinery in environments which are exposed to explosions or frost
2. The temperature of the environment in which the equipment is installed and used must
be between 10 ° C and 30 ° C (max 40 ° C for storage).
3. The relative humidity environment of use or storage must be understood between 30%
and 70%; pressure 500hpa at 1060hpa
4. During installing, check that the electrical tension on the sticker on the machine
corresponds to that in use in order to avoid damaging.
5. The building, repairing, modifying, calibration and all the other operations that require
the opening of the unit should be carried out by personnel authorized by Medi-Care
Solutions.
6. The electric circuit in which the unit is connected to, should comply to the IEC 64.8 Sec.
710 regulation (regulation regarding electrical circuits in rooms used for medical
purposes).
7. The machinery should be used exclusively following the instructions illustrated in this
manual.
8. Medi-Care Solutions refuses any responsibility for the following: damages or accidents
caused by the carelessness of the user, the non compliance to the safety rules, a non
correct use of the machine, a use of the machine which is different to that of its
purpose.
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9. Medi-Care denies all responsibility which has nothing to do with faults in the material
and non correct building.
10. Before installation and functioning check that there are not loose parts, burnt electric
cables, or various anomalies and if they are evident please contact EUROCLINIC or
authorized technical staff.
11. Mobile phones and radios can influence the good functioning of medical device
12. If during the use of the MD happen strange changes of performance or various
anomalies we suggest to interrupt all operations, switch off the machine and contact
authorized MEDI-CARE SOLUTIONS’ staff in order to avoid any kind of damage.
13. Do not install this unit in places exposed to the risk of explosions, rich in oxygen or
exposed to frost
14. The DM is not protected against splashing water and foreign bodies: DEGREE IP20
15. WARNING!: To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
16. WARNING!: There shall be no modification of this device
17. WARNING! In the event of a serious accident occurring in relation to the device, it is
necessary to report to the Manufacturer and the competent authority of your country
18. WARNING! The DM in question should not be used adjacent to or stacked with other
equipment, if necessary use it close to or stacked with other equipment it is necessary
to observe the DM to check whether, in the configuration in which it is used, its
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operation remains normal
19. The MD can be transported and stored with the environment :
Temperature : da -10°C a 60°C ;
Humidity : 10% - 90% ;
Pressure = by 500hpa at 1060hpa
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USE DESTINATION
The WLS ED300 Led Light Source is an equipment that allows to generate cold light that will be
transferred to endoscopy instruments.
WLS ED300 Light Source must be utilized only for the use it has been specifically planned and
assembled for, every other use is improper and dangerous, therefore Medi - Care Solutions srl.
denies liability for damages caused by improper use.
It 's not the intended use of the device in the surgery room
EQUIPMENT PLACEMENT
Please, put the equipment on an horizontal surface that must be sufficiently large, solid
and stable.
Connect the power-supply cable to the plug;
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Connect the plug in a 220V, 50 Hz socket provided with efficient ground connection;
ENVIROMENTAL COMPLIANCE
The environment to use the equipment in must be hospital-type exempt from strong electric
interferences and therefore far from high tension conductors, from large transformers, from x-
ray implants, from diathermy and marconitherapy generators.
Further inconvenience elements are elevator’s contactors, automatic gear-cases, some lacks of
the electric implant, such as conductors not perfectly fixed to the lamp-holders, to the current
plugs, to the switches, etc.. In normal conditions the machine is capable of functioning without
particular precautions. In critical conditions, that is when the inconveniences menace to
compromise the performance of the good performance of the test, it is necessary to connect all
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equipment to a single efficient ground outlet.
It 's not the intended use of the device in the surgery room
OPERATOR COMPLIANCE
The operator, in charge of use WLS ED300 must have read and understood the instruction
manual, therefore he must be able to recognize a potential malfunctioning and capable of
following the procedure recommended in the manual.
The operator , in charge of use ED300 must be an ENT professional.
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KIND OF FUNCTIONNING
WLS ED300 Light Source is a machine, whose operates in continuous way.
FUNCTIONING FAULTS
Not being an explosion-proof system, it is necessary the user not to use it near flammable
anaesthetic.
Do not leave the WLS ED300 Light Source exposed to atmospheric agents
Do not leave the WLS ED300 Light Source on if not used.
The limitations are specific situations in which the endoscopic visit a is not preferably advisable
and in consequence the device must be used with a limitation related to the costs/benefits
relation, deriving from the use of the system.
The DM is not protected against splashing water and foreign bodies: DEGREE IP20
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COUNTER EFFECTS
Counter effects are those specific situations in which test execution modalities can damage
patient clinic conditions, always considering the costs/benefits relation, deriving from the use
of the system.
WARNING, POSSIBLE UNDESIRED EFFECTS
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Before using the Light Source, always remember to not address the handpiece towards
anybodies eyes standing at 1 meter from the handpiece: the light might cause annoyance and
blunder to the patient, causing a disagreeable sensation.
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DESCRIPTION OF INSTALLATION AND/OR ASSEMBLING
PROCEDURE
ENVIRONMENT COMPLIANCE
The environment in which the equipment is used must be hospital-type exempt from strong
electric interferences and therefore far from high tension conductors, from large transformers,
from x-ray implants, from diathermy and marconitherapy generators.
Further inconvenience elements are elevator’s contactors, automatic gear-cases, some lacks of
the electric implant, such as conductors not perfectly fixed to the lamp-holders, to the current
plugs, to the switches, etc.
In normal conditions the MD is capable of functioning without particular precautions. In critical
conditions, that is when the inconveniences menace to compromise the performance of the
good performance of the test, it is necessary to connect all equipment to a single efficient
ground outlet.
The installation of the equipment must be made respecting the instructions of the following
booklet of instructions.
The user should always make sure that the electric circuit complies to IEC values (in other
words: 220/240 Vac, alternate monophase 50 Hz, the plant should comply with IEC 64.8 sec.
710 regulation).
It is advisable to insert the plug in a socket with a bipolar switch compliant to IEC and having
13
the following technical characteristics:
230 Vac - 50 A contact opening of 3 mm.
ACTIONS TO BE EXECUTED BEFORE SWITCHING THE SYSTEM ON
Do not connect to electric current; connect and check all connection cables .
Push away all non-used cables and those near the system, they might cause encumbrance.
Furthermore not being an explosion-proof system, it is necessary not use it near flammable
anaesthetic.
Check at sight all system components integrity.
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FIRST ACTIONS TO BE EXECUTED
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Make sure that back switch (I/O) is on O position, insert power supply provider connector on
the back panel (12V DC); after this, connect the power provider to power supply (220V~).
After inserting led hand-piece connector into the forward-panel in L1 position, you must push
I/O switch on I position and make sure that the display is on and also that the led hand-piece
fan is working.
After this checking, you can connect your optic to led hand-piece and you can select the
desired quantity, rotating the adjustment knob of light power towards the right side.
EMERGENCY SIGNAL AND WARNING
Always remember not to turn the hand-piece towards the eyes of any people present in 1 m.
range from the hand-piece. In fact, the light issued could disturb and dazzle giving an
unpleasant sensation. The forward-panel display not only gives the percentage of light power
(issued by led power), but also it allows to view information about system condition. WLS
ED300 system is adjusted by the microprocessor that controls and adjusts the most important
functions and it indicates different functioning in comparison with the expected ones, through
messages viewed on the display.
Messages that could appear on the display are the following ones:
--LL--: low level battery
--HH--: High temperature hand-piece – led hand-piece not connected
--E0--: control box breakdown
--E1--: overheated battery
--E2--: fault battery (battery model)
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--E3--: broken led or mistake in connecting the led hand-piece
--E4--: not working led adjuster
--E5--: Insufficient input tension to charge the battery
--E9--: Error memory Error parameters
--nC--: led hand-piece not connected
ACTIONS TO BE EXECUTED AFTER READING THE MESSAGES:
--LL--:
Connect WLS ED300 system to the power supply through (12V DC) power
provider (supplied)
--HH--:
Automatically, the system interrupts the power supply to led power. Make sure
that the fan placed inside the hand-piece is working. If not, disconnect power
supply feeder (220V~) and put the switch O/I on O and call Technical Assistance
of Medi - Care Solutions srl.
If the fan is working, please, wait the hand-piece temperature to come in the
normal values ranges. Automatically, the led will start again to issue the light.
--E0--:
Disconnect power supply provider (220V~) and place the O/I switch into O, Call
Medi - Care Solutions srl. Technical Assistance
--E1--:
Disconnect power supply provider from the electrical network (220V~) and place
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--E2--:
--E3--:
--E4--:
--E5--:
the O/I switch into O. Call Medi - Care Solutions srl. Technical Assistance
Disconnect the power supply provider (220V~) and place the O/I switch into
O. Call Medi - Care Solutions srl. Technical Assistance
Make sure that the hand-piece connector is correctly inserted. If you remark that
the led remains turned off, call Medi - Care Solutions srl. Technical Assistance
Disconnect power supply provider (220V~) and place the O/I switch into O
Make sure that you are using the power supply provider of standard production
equipment you get together with the system. It must issue a at least 12V DC
tension. Call Medi - Care Solutions srl. Technical Assistance.
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The user must pay attention to the actions that are necessary to keep the device in good
check that green Led, placed on the right of anterior panel, is on, while the
lace, after
Require periodical checks (every years) to Euroclinic Company in order to verify
--E9--:
Disconnect power supply provider from the electric network (220V~) and place
the O/I switch into O. Call Medi - Care Solutions srl. Technical Assistance.
--nC--:
Make sure that the hand-piece connector is right inserted and screwed in its L1
Place. Call Medi - Care Solutions srl. Technical Assistance.
PERIODICAL START UP
conditions, in order to make a "periodical start up" it in total efficiency:
verify the integrity of device and of its components
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device is working
Always check that the hand-piece fan is working while the device is turned on
place the device in an environment with the following features:
Temperature from: 20° to 45°C
Relative humidity from: 30 to 75%
Atmospheric pressure from: 700 to 1060 hPa
Please, after making sure that I/O switch is in O position and the power supply
provider (12 V DC) is connected, remove powders from control box using a humid
cloth;
in case of prolonged inactivity, it is preferable to cover VNYS ED600 together with
its accessories (mask, camera and 12VDC power supplier) in a hiding p
providing to a simple removal of the possible dust.
light power supply of the equipment.
Check to have the equipped power supplier of system electricity connection
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MANUFACTURER RESPONSIBILITIES
The WLS ED300 light system produced by Medi - Care Solutions srl., is guaranteed against
potential production and/or material defects for one year from the purchasing date and
according to the following conditions:
The room interior wiring must comply with the current IEC regulations.
The equipment must be used following the instructions and regulations as in the
present manual.
Installation, modifications and repairs must be executed by technicians authorized by
Euroclinic Company.
The following voices are not under warranty:
Defects caused by normal deterioration
Parts subject to wearing out
Malfunction caused by damaging (accidental causes), by maintenance or modifications
executed by non-authorized persons.
Defects caused by the machine’s use for different purposes from those it’s been built for
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, or modifications made by personnel not authorized by Medi - Care Solutions srl..
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USE INDICATIONS
GENERAL DESCRIPTION
This document describes WLS ED300 light source functioning, light generator for endoscopy
instruments. WLS ED300 new light source introduces 2 main new features: the usage of a
power led (instead of the traditional incandescence light) and the led hand-piece direct
connection to the optic (without the duty to use the standard optic fibres cable as inter-
connection between the source and the optic. Power led temperature is 5.500 K°, therefore
white light. The other innovation is the led placed on the hand-piece that allows to avoid the
use of optic fibres cable, reducing the costs of the system. After you have made the operations
described in the paragraphs “ACTIONS TO BE EXECUTED BEFORE SWITCHING THE SYSTEM
ON” and “First actions to be executed” it will be sufficient to connect the Led hand-piece
directly to the optic to use and adjust the light power through the knob place on the right of
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the equipment forward panel .
The display present on the panel consents to realize about light power percentage selected
through the knob. The light power issued by the power led can be increased or reduced using
the knob placed on the right side of the forward panel, otherwise, using the buttons and
.
The button is useful to call a power percentage previously saved; that value is the last
adjusted and unchanged for 2 seconds
The button consents to reset to zero the value of the power percentage issued to the led.
The system autonomy (not connected to power supply , 220 V~) depends on the charge
batteries and use 100% of light power can change from 1 to 2 hours.
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CONTROLS DESCRIPTION
1. Handpiece connector
FORE PANEL MASTER STATION
1
2
3 4
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2. Display
3. Increase/Decrease % power value and Enter buttons
4. Increase/Decrease % power value knob
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CLEANING ED300
The choice of materials used for building the unit has been carefully taken in order to
correspond to the cleaning and disinfecting needs. Given the big differences between chemical
products used in a medical study, it is possible to ruin the surfaces. The major damages are
caused by the amount of time that these chemical products are left on the tops. It is important
to immediately dry the interested parts with a damp cloth. To clean the painted or metal parts,
use a specific product for these materials which doesn’t damage their composition.
IMPORTANT! Do not use products with alcohol, ammonia or petrol
DO NOT USE SOLVENTS OR ALCOHOL FOR CLEANING AND DISINFECTING. THE USE
OF THESE PRODUCTS CAN DAMAGE THE PLASTIC PIECES OF THE SYSTEM
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Cleaning and disinfecting products chart
Disinfectants Pharmaceutic products and
cosmetics
+ bactol 5%
+ clorammina
- DDT
+ delegol 5%
= dimammina 5%
= iodine dye
- fenic acid
+ lysoform 2%
- TB lysoform
+ bactol
+ merfen 2%
+ octozone
+ perydrol
+ resorcina 1%
= sagrotane 5%
+ alcohol to be purely burnt
+ mercury chloride
+ blood plasma
+ sun tan lotion
+ hydroplex
= iodine dye
+ lanolyn
= mantolo 90% in alcohol
-nail varnish
- solvent
+ mouth wash
+ periston R
+ vaselyn
+ vicks rub
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+ trosilina G
+ oxiginated water
= zefirol
CHART SIGNS
+ compatible
- non compatible
= compatible but with caution
TECHNICAL FEATURES
Electrical tension: 12V DC
Frequency: 50 Hz
Power absorbed: 25W
Weight 3.7 Kg
Dimensions Max(in mm): 300 x250 x 120
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FAULTS RESEARCH
It could happen that the equipment could not execute the desired function. Tray to solve the
problems alone, before calling Assistance technician. The following checking list could help to
identify and cancel possible faults.
THE EQUIPMENT DOES NOT START
Make sure that power supply cable plug is inserted on the outlet socket (that must be
active 220V~)
Make sure that I/O switch is ON
Call Euroclinic technical assistance service
Send the equipment to Technical assistance service
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1. GUIDE TABLES AND MANUFACTURER'S DECLARATION
The electro-medical device requires special precautions regarding EMC (Electromagnetic Compatibility) and must be
installed in accordance with the EMC information contained in the accompanying documents.
Portable and mobile radio-communication equipment can affect the operation of EUT (Equipment under test).
The use of accessories, transducers and cables other than those specified, with the exception of those sold by the
manufacturer as spare parts for internal components, may cause an increase in emissions and a decrease in immunity.
The device or the system must not be used near other devices and, if it is necessary to use it near other appliances, the
electro-medical device must be observed to check normal functioning in the configuration in which it is used.
The electro-medical device has been tested and founded in compliance with the emission and immunity limits of
electromedical equipment according to IEC60601-1-2: 2014. These limits are
specifically designed to provide adequate protection against dangerous interferences in a typical medical room.
However, there is no guarantee that interferences will not occur in a particular installation. If the electro-medical
device, interacting with another one, causes or receives detectable interferences, the user is invited to limit them by
adopting one or more of the following measures:
1. Reorient or relocate the receiving device;
2. Increase the distance between the appliances;
3. Connect the equipment to an outlet on a circuit different from the device (s) causing the interference;
4. Contact the manufacturer or local technician for assistance
Guida e dichiarazione del fabbricante – emissioni elettromagnetiche/ Guidance and manufacturer's declaration -
electromagnetic emissions
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“ED420” è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il paziente o l'utilizzatore di “ED420”
dovrebbe garantire che esso venga impiegato in tale ambiente / "ED420" is intended to operate in the electromagnetic
environment below specified. The patient or user of "ED420" should ensure that it is used in such an environment.
Prova di emissione/Emission test
Emissioni a RF CISPR 11/RF CISPR 11 Emissions
Emissioni a RF CISPR 11/RF CISPR 11 Emissions
Emissioni armoniche IEC 61000-3-2/IEC 61000-3-2
Harmonic Emissions
Emissioni di fluttuazioni di tensione/ Flicker
emissions IEC 61000-3-3
Conformità/
Conformity
Gruppo 1/
Group 1
Classe B/
Class B
Classe A/
Class A
Conformità/
Conformity
Ambiente elettromagnetico/Electromagnetic
environment
“ED420” utilizza energia a radiofrequenza solo per il
suo funzionamento interno. Di conseguenza le sue
emissioni a RF sono molto bassa e verosimilmente
non provoca alcuna interferenza negli apparecchi
elettronici posti nelle vicinanze. / "ED420" uses radio
frequency energy only for its internal operation. As a
result, its RF emissions are very low and are unlikely to
cause any interference in nearby electronic devices.
“ED420” è adatto per l’uso in tutti gli ambienti
compresi quelli domestici e da quelli collegati
direttamente alimentazione di rete pubblica a bassa
tensione che alimenta edifici utilizzati per scopi
domestici. /"ED420" is suitable for use in all
environments including domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
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Guida e dichiarazione del fabbricante – immunità elettromagnetica
Guidance and manufacturer's declaration - electromagnetic emissions
Il DM è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il paziente o l'utilizzatore del DM
dovrebbero garantire che esso venga utilizzato in tale ambiente. / The MD is intended to operate in the electromagnetic
environment specified below. The patient or user of the MD should ensure that it is used in such an environment.
Prova di
immunità/Immunity
test
Scarica elettrostatica
ESD/ Electro-static
download (ESD)
IEC 61000-4-2
Transitori/sequenza di
impulsi elettrici rapidi/
Fast electrical transients
/ pulse sequence
IEC 61000-4-4
Sovratensioni/
Overvoltage
IEC 61000-4-5
Buchi di tensione, brevi
interruzioni e variazioni
di tensione sulle linee di
ingresso
dell'alimentazione
/Voltage dips, brief
interruptions and voltage
variations on the power
input lines
IEC 61000-4-11
Livello di prova della
IEC 60601/IEC 60601
test level
± 8kV a contatto/in
contact
± 2; 4; 8; 15 kV - air ± 2; 4; 8; 15 kV - air
±2kV per le linee di
alimentazione/ power
feeding lines
± 1 kV per le linee di
ingresso/uscita
entrance/exit lines
± 1kV tra le fasi/among
phases
± 2kV tra le fasi/among
phases and earth
0% UT for 0,5 cycle 0% UT for 0,5 cycle
0% UT for 1 cycle 0% UT for 1 cycle
70% UT for 25 cycle 70% UT for 25 cycle
0% UT for 250 cycle 0% UT for 250 cycle
Livello di conformità/
Conformity level
± 8kV a contatto/in
contact
± 2kV per le linee di
alimentazione /power
feeding lines
± 1 kV per le linee di
ingresso/uscita
entrance/exit lines
± 1kV tra le fasi/among
phases
± 2kV tra le fasi/among
phases and earth
Ambiente elettromagnetico
Electro-magnetic environment
I pavimenti devono essere in legno,
calcestruzzo o in piastrelle di ceramica. Se i
pavimenti sono rivestiti di materiale sintetico,
l’umidità relativa dovrebbe essere almeno pari
al 30%. / Floors must be in wood, concrete or
ceramic tiles. If the floors are covered with
synthetic material, the relative humidity should
be at least 30%.
La qualità della tensione di rete dovrebbe
essere quella di un tipico ambiente
commerciale o ospedaliero.
In caso di burst a 2 kV su linea di
alimentazione si può verificare un lieve
sfarfallio del display, che non pregiudica la
sensibilità del touch screen o l’erogazione
della terapia, né la sicurezza del paziente o
l’operatore. / The quality of the main voltage
should be the one typically used in
commercial or hospital environment. In the
event of a 2 kV burst on the power supply line,
the display may flicker slightly, which does not
affect the sensitivity of the touch screen or
therapy delivery, nor the safety of the patient
or operator
La qualità della tensione di rete dovrebbe
essere quella di un tipico ambiente
commerciale o ospedaliero. / The quality of
the net voltage should be the one typically
used in commercial or hospital environment.
La qualità della tensione di rete dovrebbe
essere quella di un tipico ambiente
commerciale o ospedaliero. Se l'utilizzatore di
richiede un funzionamento continuato durante
le interruzioni della tensione di rete si
raccomanda di utilizzare il DM con un gruppo
di continuità. / The quality of the main voltage
should be the one of a typical commercial or
hospital environment. If the user requires
continued operation during power
interruptions, it is recommended to use the
MD with a UPS
24
Campo magnetico ad
alta frequenza (50/60
Hz) / High frequency
magnetic field (50/60Hz)
IEC 61000-4-8
30 A/m
NOTE: UT è la tensione di rete in c.a. prima dell’applicazione del livello di prova
UT is the main voltage before applying the test level.
Non applicabile, il
dispositivo non contiene
componenti suscettibili ai
campi magnetici. /Not
applicable.
I campi magnetici a frequenza di rete
dovrebbero avere livelli caratteristici di una
località tipica in un ambiente commerciale o
ospedaliero. / Power frequency magnetic
fields should have characteristic levels of a
typical location in a commercial or hospital
environment.
Page 26
Guidance and manufacturer's declaration - electromagnetic emissions
Il DM è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il cliente o l'utilizzatore del
DM dovrebbero garantire che esso venga utilizzato in tale ambiente. Gli apparecchi di comunicazione a RF
portatili e mobili non dovrebbero essere usati più vicino a nessuna parte di, compresi i cavi, della distanza di
separazione raccomandata calcolata con l’equazione applicabile alla frequenza del trasmettitore/ The MD is
intended for operation in the electromagnetic environment specified below. The customer or user of the MD
should ensure that it is used in such an environment. Portable and mobile RF communications equipment
should not be used closer to any part of, including cables, than the recommended separation distance
calculated with the equation applicable to the transmitter frequency.
Prova di immunità/Immunity test
RF Condotta/ Conducted RF
IEC 61000-4-6
Livello di prova della IEC
60601/IEC 60601 test level
3 Veff
from 150kHz to 80 MHz
Livello di conformità/
Conformity level
3 Veff
Distantaza taccomandata
d: Recommended
distance d:
d= 30 cm
25
RF Irradiata/Irradiate RF
IEC 61000-4-3
Immunità a campi di
prossimità da dispositivi di
comunicazione RF wireless
IEC 61000-4-3 / Proximity
field immunity from wireless
RF communication devices
IEC 61000-4-3
3 V/m
da/from 80 MHz to 2,5 GHz
TETRA 400
380 – 390 MHz
V/m
GMRS 460
FRS 460
430 – 170 MHz
V/m
LTE Band 13, 17
704 – 787 MHz
V/m
GSM 800/900, TETRA
800, iDEN 820, CDMA
850, LTE Band 5
V/m
800 960 MHz
GSM 1800; CDMA
1900; GSM 1900;
DECT; LTE Band 5
V/m
1700 – 1990 MHz
Bluetooth, WLAN,
802.11 b/g/n, RIFD
2450, LTE Band 70
V/m
2400 – 2570 MHz
WLAN 802.11 a/n
5100 – 5800 MHz 9 V/m
27
28
9
28
28
28
3 V/m
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
d= 30 cm
d= 30 cm
Page 27
TECHNICAL ASSISTANCE SERVICE
OF
MEDI - CARE SOLUTIONS SRL.
TEL. / PHONE: +39 0542 642046
FAX: +39 0542 642355
E-MAIL: info@euroclinic.it
!!!!!! VERY IMPORTANT ADVICE !!!!!!
Before sending back the equipment, even if it is covered by its
26
warranty, it is necessary to forewarn and require Medi - Care Solutions
srl. authorisation. Otherwise, the warranty could fall into decay.
In case, due to any reason, the equipment must be delivered to the
technical assistance service, we suggest to use the original packing, in
order to avoid eventual damages due to transport.
Therefore Medi - Care Solutions srl. declines any responsibility in
relation to these damages and will charge the new packing to be used
for sending again the equipment to the customer.
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