Ecleris PORTALED User manual

USER MANUAL
PORTALED
INFORMATION ABOUT THIS MANUAL
Version: 2021.10
Year: 2021
Language: English
All the rights to this manual are reserved, especially reproduction, publication and translation rights. No portion of this manual may be
reproduced by no means (photocopy, microfilm or other methods) without previous written authorization from ECLERIS. Neither can it
be reproduced, multiplied or published through any electronic data processing form.
The information contained in this manual may be modified or broaden without previous notification, without it representing any
responsibility to ECLERIS.
ECLERIS USA
11801 NW 100th Rd
Suite 17
Medley, FL 33178
Phone: [phone]
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº18, CP29006,
Málaga-Spain
e-mail: [email protected]

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TABLE OF CONTENT
1. SYMBOLS................................................................................................................................3
2. SECURITY WARNINGS ..........................................................................................................3
2.1 WARNINGS..........................................................................................................................3
3. DESCRIPTION.........................................................................................................................4
3.1 INTENDED USE...................................................................................................................4
3.2 INTENDED USER ................................................................................................................4
3.3 FEATURES AND DESCRIPTION.........................................................................................5
4. USE INSTRUCTIONS..............................................................................................................7
4.1 ENDOSCOPE CONNECTION..............................................................................................7
4.2 FIBER OPTIC CONNECTION..............................................................................................8
4.3 BELT HOLDER.....................................................................................................................8
5. MAINTENANCE.......................................................................................................................9
5.1 BATTERY CHARGING AND REPLACING...........................................................................9
5.2 BATTERY USE AND CARE ...............................................................................................11
5.3 CLEANING AND DISINFECTION.......................................................................................12
5.4 PRODUCT CARE...............................................................................................................12
6. TECHNICAL SPECIFICATIONS // ESPECIFICACIONES TÉCNICAS...................................12
7. TECHNICAL SERVICE..........................................................................................................14
8. WARRANTY ..........................................................................................................................14

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1. SYMBOLS
Refer to instruction manual
CE Mark
Warning
EU Authorized
Representative
Caution
Manufacturer’s
information (name,
address)
Serial number
Date of manufacture
Product code
Do not discard with the
household waste
Type BF Applied part
Fragile
Keep away from rain
This way up
2. SECURITY WARNINGS
This manual describes the recommended procedures for the PORTALED installation and use. It
contains all the necessary information for PORTALED care and appropriate use.
A warning alerts you to a situation that, if not avoided, could result in death or serious
injury.
A caution alerts you to a potentially hazardous situation which, if not avoided, could result
in minor or moderate injury to the user or patient, or damage to the equipment or other
property.
Should you have any doubt about the contents of this manual, operation or safety of the
equipment, please contact your local distributor or the nearest ECLERIS office.
Thank you for purchasing this product. To prevent damage to your product or injury to
you or to others, read the following safety precaution in their entirety before using this
device. Keep these safety instructions where all those who use the product will read
them.
2.1 WARNINGS
Please carefully read the entire manual before using the device.

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This product must not be used in the presence of a flammable anesthetic mixture with air
or oxygen or nitrous oxide.
This product must not be used in oxygen enriched environments.
This product should not be immersed in fluids.
Do not look directly into the light output, the head has a very bright light output.
The main plug must be accessible in order to quickly disconnect the device from the mains
if necessary.
The sectioning of the electrical network is carried out by disconnecting the power cable
from the electrical outlet.
In case of interference with other electro medical or electric equipment, it is recommended
increasing the distance between the PORTALED and the other equipment to minimize
these effects.
This product cannot be changed, rebuilt or modified in any way.
Do not open the equipment, except to replace the battery according to the instructions.
Maintenance and repairs must be done by ECLERIS or an authorized company. ECLERIS
will not be responsible for the consequences of repairs or maintenance carried out by
unauthorized personnel.
This instruction manual must be kept together with the equipment for future reference.
Should the equipment be sold or donated, this manual must be enclosed.
If by any of the following:
Inadequate use of the equipment.
Failure to use the instruction manual.
Bad maintenance and care of the equipment.
Repair or manipulation by unauthorized personal.
…personal or material damage is produced to a third party, ECLERIS, the manufacturer and
sales agent of this equipment, will not assume responsibility for said damage.
The device and its accessories should never be discarded with the household
waste. Please check local regulations for electronic components disposal or recycle
of electrical and electronic device.
3. DESCRIPTION
3.1 INTENDED USE
The pocket size LED light source PORTALED is used to illuminate endoscopes both rigid and
flexible with compatible fiber optic cables.
Do not shine the light directly into the patient's eyes.
3.2 INTENDED USER
The device has been designed to be used by health professionals.

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3.3 FEATURES AND DESCRIPTION
Very low power consuming LED lamp that avoids heat generation and has a lifespan of
50000 working hours.
The light color temperature is 6000 Kelvin, which supplies bright, white, shadow-free light
allowing an optimal visualization.
The PORTALED has adapters for different fiber optic connections.
The PORTALED uses a rechargeable Lithium battery, and can be used without the direct
power source. It is a comfortable lightweight pocket size LED light source and it is suitable
for all kinds of medical procedures.
The PORTALED could be used for 1.5 hours of continuous use.
Smart design, ergonomic and compact for mobile diagnosis.
The PORTALED consists of the following elements:
1. Carrying case
2. Illuminator
3. Charging pad
4. Power supply
5. European power adapter
6. US power adapter
7. Belt holder
1
2
3
4
6
7
8
5

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8. Adapters:
oStorz for fiber optic
oOlympus for fiber optic
oStorz for endoscope
oWolf for endoscope ( optional )
A. ON/OFF switch
B. Lighting head
C. Optical Endoscope coupling
D. Charging pad
E. Power supply
F. Power supply adapter
A
B
C
D
E
B
F

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4. USE INSTRUCTIONS
4.1 ENDOSCOPE CONNECTION
Attach the PORTALED to the endoscope by threading the corresponding coupling to the light
guide connector in the case of Storz type, and by pushing in the case of the Wolf type connector.
Turn on the PORTALED by pressing the ON/OFF switch.
Once the procedure is finished, turn off the PORTALED by pressing the ON/OFF switch in order
to maximize the LED and the battery lifetime.

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4.2 FIBER OPTIC STORZ TYPE CONNECTION
Release the fixing piece unscrewing it in order to introduce the distal end of the fiber optic cable,
then adjust it using the fixing screw.
4.3 BELT HOLDER
The PORTALED can be attached to a belt holder. The belt holder allows the operator to handle
the endoscope more comfortably when using a fiber optic cable. The steps for a correct fastening
of the holder can be seen in the following images:

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5. MAINTENANCE
5.1 BATTERY CHARGING AND REPLACING
For battery charging place the PORTALED on the charging pad, on its flat side, and connect the
power supply to the charging pad and to the electrical network. The estimated time for full battery
charge is 4 hours.
The light on the charging pad will turn on blue to indicate that the charging pad is connected and
the battery is charging.
The battery could be charged and discharged more than 500 times, however in the course of time
it will start to run down. When working periods of use are remarkable shorter than normal, replace
the battery. Use only ECLERIS approved batteries and chargers for quality assurance and
safeguards.
CHARGING PAD

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The PORTALED must not remain turn on while it is charging.
Do not place other objects on the charging pad while the PORTALED is charging.

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For battery replacement, unscrew the battery lid, disconnect the connectors and remove the battery
from the PORTALED.
The battery replacing can be carried out by non-specialized personnel.
Turn off the PORTALED before replacing the battery.
Use only ECLERIS approved batteries and chargers for quality assurance and
safeguards. ECLERIS warranty does not cover damage to the PORTALED caused by
non-approved batteries and/or chargers.
Contact your local distributor for ECLERIS approved accessories availability.
The battery should never be discarded with the household waste. Please check local
regulations for Lithium batteries disposal or recycling.
5.2 BATTERY USE AND CARE
The capacity of Lithium battery will change by means of its conditions of use. For maximum
battery capacity, use the battery in suitable environmental conditions (See Technical
Specifications). Do not expose the battery to extreme temperatures, if the battery is used in high
or low temperatures, the battery capacity will be reduced.
Safe extraction: Always turn the PORTALED off before removing the battery.
Lithium battery

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5.3 CLEANING AND DISINFECTION
Clean the outer surface of the PORTALED with a cloth dampened with mild detergent or soap.
The remaining stains can be cleaned off with the mixture of 50% alcohol and 50% distilled water.
Only use products suitable for cleaning the external surfaces of electrical equipment, prepared
according to the manufacturer's instructions.
Disinfect the PORTALED with a clean cloth dampened with a 70% ethanol solution. It is
recommended to put ethanol on the cloth and not on the surface of the device.
Do not use detergents, solvents or abrasive agents.
The PORTALED is not sterilizable.
Caution: Be careful to prevent the solvent into the instrument. Do not sterilize the
PORTALED by soak, high temperature or high pressure.
5.4 PRODUCT CARE
The PORTALED has a useful life of 5 years. It is recommended to comply with the following to
ensure its integrity and correct operation:
Do not expose the device to liquids or to humidity.
Do not touch the surface of lens with hands or hard objects.
If it is not used for a long period, please take the battery out.
6. TECHNICAL SPECIFICATIONS // ESPECIFICACIONES TÉCNICAS
MECHANICAL CONNECTION
Storz, Wolf and Olympus compatible.
Weight
PORTALED
2.1 pounds (Device and accessories inside the carrying
case)
0.4 pounds (Iluminator)
ELECTRICAL SPECIFICATIONS
Illumination type
Extremely bright light, 5W LED, life > 50000 hours of
continuous use, do not need to replace the LED lamp
Battery
3.7 V, 2500 mAh, 9.25 Wh Lithium battery
Battery Run-time
1, 5 hours continuous run-time on a fully charged battery
Charger Rating Voltage
100-240 VAC, 50 / 60Hz
Power adapter output
DC: 5.0V, 2.0A
Power: 10 VA
Class
Charger: Clase II
Illuminator: Battery powered
Use
Continuous
Applied part
Type BF
Degree of protection
against entry of water
IPX0
ENVIRONMENTS REQUIREMENTS
Use conditions
Temperature
10 °C –40 °C (50ºF - 104ºF)
Relative humidity
35 - 75 %

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Pressure
700 –1060 hPa
Storage and
transportation conditions
Temperature
-30 °C - 50 °C (-22 °F - 122 °F)
Relative humidity
10 –95%
Pressure
500 –1060 hPa

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7. TECHNICAL SERVICE
The PORTALED must be repaired and/or maintained exclusively by authorized ECLERIS
technical services. ECLERIS recommends using the following procedures for a quicker repair
service and replacement of guaranteed products.
1) Contact the technical service department of your local distributor or the nearest ECLERIS
office.
2) Give detailed information of the problem.
3) If the problem cannot be solved by troubleshooting, the product shall be sent for its repair.
The following product information shall be attached:
Owner’s name.
Owner’s address.
Contact name and phone number.
Product’s serial number.
Problem’s description.
The PORTALED shall be sent in its original packaging so that it is not damaged during
transportation. ECLERIS shall not be liable for damages that may occur during transportation,
caused by deficient packaging.
8. WARRANTY
ECLERIS states that the PORTALED has complied with the required Quality Control verification
and has no manufacturing defects. This guarantees the appropriate functioning under adequate
use in agreement with the indications of this manual. The warranty period is for one (1) year as
from the date of purchase invoice.
ECLERIS shall not be liable for any damage caused to/by the PORTALED due to incorrect use,
negligence, cleaning or incorrect storage. Any repairs made by personnel not authorized by
ECLERIS will void this warranty. The described warranty is exclusively valid for the original
buyer.
The following parts are excluded from the warranty:
Battery
Damages resulting from connections to inadequate power supplies.
Disregarding the warranty situation, all shipment from and to the authorized ECLERIS technical
service facilities is the sole responsibility of the client.

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MANUAL DE USUARIO
PORTALED
INFORMACION SOBRE ESTE MANUAL
Versión: 2021.10
Año: 2021
Idioma: Español
Todos los derechos son reservados. La reproducción o la transmisión entera o parcialmente, en cualquier forma o por cualquier
medio, electrónico, mecánico o de otra manera, se prohíbe sin el consentimiento escrito anterior del dueño de derechos reservados.
La información contenida en este manual puede ser modificada o ampliada sin notificación previa, sin que ello represente
responsabilidad alguna para ECLERIS.
ECLERIS USA
11801 NW 100th Rd
Suite 17
Medley, FL 33178
Phone: [phone]
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº18, CP29006,
Málaga-Spain
e-mail: [email protected]

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TABLA DE CONTENIDO
1. SIMBOLOGIA ........................................................................................................................17
2. INFORMACIÓN DE SEGURIDAD..........................................................................................17
2.1 ADVERTENCIAS................................................................................................................17
3. DESCRIPCION......................................................................................................................18
3.1 USO PREVISTO.................................................................................................................18
3.2 USUARIO PREVISTO........................................................................................................18
3.3 CARACTERISTICAS Y DESCRIPCION.............................................................................19
4. INSTRUCCIONES DE USO...................................................................................................21
4.1 CONEXIÓN A ENDOSCOPIO............................................................................................21
4.2 CONEXIÓN A FIBRA ÓPTICA ...........................................................................................22
4.3 SOPORTE PARA CINTURÓN............................................................................................22
5. MANTENIMIENTO.................................................................................................................23
5.1 CARGA Y REEMPLAZO DE LA BATERIA.........................................................................23
5.2 USO Y CUIDADO DE LA BATERÍA....................................................................................25
5.3LIMPIEZA Y DESINFECCIÓN............................................................................................26
5.4 CUIDADO DEL PRODUCTO..............................................................................................26
6. ESPECIFICACIONES TÉCNICAS .........................................................................................26
7. SERVICIO TÉCNICO.............................................................................................................28
8. GARANTIA.............................................................................................................................28

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1. SIMBOLOGIA
Es obligatorio consultar la
documentación acompañante
Marcado CE
Advertencia
Representante autorizado
en Comunidad Europea
Precaución
Identificación del
fabricante (nombre,
dirección)
Número de serie
Fecha de fabricación
Código del producto
No desechar como
residuo sin clasificar
Parte aplicable Tipo BF
Frágil
Proteger contra el agua
Arriba
2. INFORMACIÓN DE SEGURIDAD
Este manual describe los procedimientos recomendados para la instalación del PORTALED y su
uso. Contiene toda la información necesaria para el cuidado y el uso apropiado del PORTALED.
Una advertencia alerta sobre una situación que, si no se evita, podría provocar la muerte
o lesión grave.
Una precaución alerta sobre una situación potencialmente peligrosa que, si no se evita,
puede resultar en lesiones leves o moderadas al usuario o al paciente, o daños al equipo
u otra propiedad.
Ante cualquier duda sobre el contenido de este manual, la operación o seguridad del equipo,
comuníquese con su distribuidor local o con la oficina de ECLERIS más cercana.
Gracias por adquirir este producto. Para prevenir daños a su persona u otros, lea las
advertencias y precauciones de seguridad completas antes de utilizar el dispositivo.
Guarde estas instrucciones en un lugar accesible para todos aquellos que vayan a
utilizar el producto, de manera tal de garantizar que todos ellos las leerán.
2.1 ADVERTENCIAS
Lea cuidadosamente todo el manual antes de utilizar el equipo.

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Este dispositivo no está apto para ser utilizado en presencia de una mezcla anestésica
inflamable con aire u oxígeno u óxido nitroso.
Equipo no previsto para ser utilizado en ambientes enriquecidos con oxígeno.
Este producto no debe sumergirse en fluidos
No mire directamente hacia la salida de luz, el cabezal de iluminación posee una salida
de luz muy brillante.
La ficha de red de alimentación debe quedar siempre accesible para poder desconectar
rápidamente el aparato de la red eléctrica en caso de ser necesario.
La manera de desconectar el aparato efectivamente de la red eléctrica es desconectando
la fuente de alimentación del tomacorriente de red.
En caso de interferencia con otros equipos electromédicos o eléctricos con bajo nivel de
inmunidad, se recomienda aumentar la distancia entre el equipo y resto del equipamiento
interferido para minimizar estos efectos.
No se puede cambiar, reconstruir ni modificar de ninguna manera este producto.
No abra el equipo, excepto para cambiar la batería según las instrucciones. El
mantenimiento y las reparaciones deben ser realizados por ECLERIS o una empresa
autorizada por ésta. ECLERIS no se responsabiliza por las consecuencias de
reparaciones o mantenimientos efectuados por personas no autorizadas.
Este manual de instrucciones debe permanecer junto al equipo para futuras consultas. En
caso que el equipo sea vendido o donado, el manual deberá acompañarlo.
Si como consecuencia de:
Uso inadecuado del equipo
No utilización del manual de instrucciones
Mal cuidado o mantenimiento del equipo
Reparación o manipulación por personal no autorizado
…se produjeran daños personales o materiales a terceros, ECLERIS, el fabricante y vendedor de
estos equipos, no asumen responsabilidad alguna por dichos daños.
No deseche el dispositivo, como así tampoco ninguno de sus accesorios junto con
los residuos domésticos. Consulte las normas locales para la correcta eliminación.
3. DESCRIPCION
3.1 USO PREVISTO
La fuente de luz LED de bolsillo PORTALED es utilizada para iluminar endoscopios tanto rígidos
como flexibles compatibles con cable de fibra óptica.
No ilumine directamente los ojos del paciente.
3.2 USUARIO PREVISTO
El dispositivo está previsto que sea utilizado por profesionales de la salud.

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3.3 CARACTERISTICAS Y DESCRIPCION
Lámpara LED de muy bajo consumo que evita la generación de calor y tiene una vida útil
de 50000 horas.
La temperatura de color es de 6000 Kelvin, lo que otorga una iluminación blanca, brillante
y libre de sombras, permitiendo una óptima visualización.
El PORTALED tiene adaptadores para distintas conexiones de fibra óptica.
El PORTALED utiliza una batería de litio recargable, y puede ser utilizado sin estar
conectado a la fuente de alimentación directa. Es una fuente de luz LED de bolsillo muy
cómoda, apta para todo tipo de procedimientos médicos.
El PORTALED puede ser utilizado de manera continua por 1,5 horas.
Diseño inteligente, ergonómico y compacto para diagnóstico móvil.
El PORTALED se compone de las siguientes partes:
1. Maletín contenedor
2. Iluminador
3. Base de carga
4. Fuente de alimentación
5. Adaptador para toma de alimentación Europa
6. Adaptador para toma de alimentación Estados Unidos.
7. Soporte para cinturón
1
2
3
4
6
7
8
5

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8. Adaptadores:
oStorz para fibra óptica
oOlympus para fibra óptica
oStorz para endoscopio
oWolf para endoscopio (Opcional)
A. Botón de encendido/apagado
B. Cabezal de iluminación
C. Acople óptico para endoscopio
D. Base de carga
E. Fuente de alimentación
F. Adaptador de la fuente de alimentación
A
B
C
D
E
B
F