MANIPOLO RIUTILIZZABILE PER ELETTROCHIRURGIA
IT
EN
DE
ES
FR
ELETTRODO RIUTILIZZABILE PER ELETTROCHIRURGIA
PROLUNGA RIUTILIZZABILE PER ELETTROCHIRURGIA
REUSABLE PENCIL FOR ELECTROSURGERY
REUSABLE ELECTRODE FOR ELECTROSURGERY
REUSABLE EXTENSION FOR ELECTROSURGERY
EINMAL-ELEKTRODE FÜR DIE ELEKTROCHIRURGIE
WIEDERVERWENDBARE ELEKTRODE FÜR DIE ELEKTROCHIRURGIE
WIEDERVERWENDBARE VERLÄNGERUNG FÜR DIE ELEKTROCHIRURGIE
MANGO DE ELECTROCIRUGÍA REUTILIZABLE
ELECTRODO PARA ELECTROCIRUGÍA REUTILIZABLE
EXTENSIÓN PARA ELECTROCIRUGÍA REUTILIZABLE
MANCHE RÉUTILISABLE POUR ÉLECTROCHIRURGIE
ÉLECTRODE RÉUTILISABLE POUR ÉLECTROCHIRURGIE
EXTENSION RÉUTILISABLE POUR ÉLECTROCHIRURGIE
RU
PT
CS
АКСЕССУАРЫ ДЛЯ ЭЛЕКТРОХИРУРГИИ, РУЧКА-ДЕРЖАТЕЛЬ ДЛЯ
ЭЛЕКТРОХИРУРГИИ
PUNHO REUTILIZÁVEL PARA ELETROCIRURGIA
ELÉTRODO REUTILIZÁVEL PARA ELETROCIRURGIA
EXTENSÃO REUTILIZÁVEL PARA ELETROCIRURGIA
OPAKOVANĚ POUŽITELNÁ TUŽKA PRO ELEKTROCHIRURGII
OPAKOVANĚ POUŽITELNÁ ELEKTRODA PRO ELEKTROCHIRURGII
OPAKOVANĚ POUŽITELNÝ NÁSTAVEC PRO ELEKTROCHIRURGII
ISTRUZIONI PER L’USO ..................................................................................................... 2
DIRECTIONS FOR USE....................................................................................................... 5
GEBRAUCHSANWEISUNG................................................................................................. 8
INSTRUCCIONES DE USO ............................................................................................... 11
MODE D’EMPLOI............................................................................................................... 14
ИНСТРУКЦИЯ ПО ЭКСПЛУАТАЦИИ............................................................................... 17
INSTRUÇÕES DE UTILIZAÇÃO ........................................................................................ 21
NÁVOD K POUŽITÍ ............................................................................................................ 24
52502395IU9B / 2022-04
2797
EN
REUSABLE ELECTRODE FOR ELECTROSURGERY
REUSABLE EXTENSION FOR ELECTROSURGERY
DIRECTIONS FOR USE
INDICATIONS:
REUSABLE PENCIL FOR ELECTROSURGERY
Cutting and coagulation of tissues during electrosurgical procedures, with the use of a compatible highfrequency generator.
• REUSABLE HAND-SWITCH PENCILS WITH VALLEYLAB-TYPE CONNECTION:
- MODELS FOR ELECTRODES WITH 2,38mm (3/32”).
- MODELS FOR ELECTRODES WITH 4mm CONNECTION.
• REUSABLE FOOT CONTROL PENCILS WITH, 4mm PIN CONNECTION.
• REUSABLE ELECTRODES WITH 2.38mm (3/32”) CONNECTION.
• REUSABLE ELECTRODES WITH 4mm CONNECTION.
• ELECTROSURGERY ELECTRODES REUSABLE EXTENSIONS WITH 2,38mm (3/32")
CONNECTION.
• OTHER MODELS OF PENCILS AND ELECTRODES WITH ERBE TYPE CONNECTION
5mm.
MAXIMUM APPLICABLE VOLTAGE 9kVpp (8kVpp models for electrodes with 4mm connection)
WARNINGS
• STERILISE BEFORE USE those products which are not pre-sterilised;
• Assembly and removal procedures involving the electrode, as well as cleaning, must be carried
out only when the hand-switch pencil is disconnected from the generator.
• After controlling the packing for damages, check the hand-switch pencil, electrode, cable, and
connector. Do not use the product in the case of damages or visible defects. Instead, return it to
FIAB.
• The distal part of the hand-switch pencil can hold all models of electrodes and extensions having
a shank diameter of 2.38 mm (3/32”) or 4 mm depending on the model. Be sure that the
electrode or extension (if present) is firmly inserted in the pencil, and that the insulating coupling
of the electrode and extension (if present) is intact.
• Always check the functioning before use. For the hand-switch models, make sure that the two
push-buttons make a “click” when they are pressed. Discard defective products.
• Keep a record concerning checks carried out and the results obtained.
• Be sure that the connection of the hand-switch pencil’s plug with the generator is firm, and that
the metallic part of the connector is completely inserted.
• Do not use clips to secure the cable of the pencil to the surgical cloth, in order to avoid damage
to the cable.
• Keep the products away from inflammable materials: their accidental activation and heat could
cause fires.
• When the products are not in use, they should be kept in suitable containers.
• High-frequency electrosurgerical generators, the grounding plates and accessories to be used
with the present product, should conform to existing regulations.
• Refer to the instructions for use supplied with the product regarding use of the generator and the
grounding plates.
• The devices are to be used by trained healthcare professionals in electrosurgical procedures.
NB: pacemakers may be damaged by electrosurgical current. Do not submit a patient wearing a
pacemaker to electrosurgical current without first consulting a cardiologist.
5 / 28
CLEANING
Disconnect the pencil from the generator. Remove the electrode and extension (if present) from the tip
of the pencil. To clean the products, it is advisable to use decontaminating solutions and proteolytic
detergents for surgical instruments. While cleaning the electrodes, the operator should take care not to
wound him or herself with the blades or tips. Follow the relative instructions when using these products.
After cleaning, rinse with water and keep the pencil in an upside-down position for at least 30 minutes,
so as to enable the exit of any liquids from the tip.
• Do not press the push-buttons during the washing operation.
• Do not make forced entry of liquids or air inside the receptacle of the tip.
• Do not use ultrasound baths
• The use of mechanical washing systems may reduce the product’s life.
• Do not immerse the pencil in any sort of solution during the 4 hours following a pre-vacuum
treatment.
• Do not use abrasive mechanical systems on the insulation of the electrode or extension to
remove biological residue, as such systems could damage it.
STERILISATION
The devices in object of present instructions can be sterilised with ethylene oxide (ETO) or in an
autoclave.
NB The sterilisation process used must conform with existing regulations.
• Validation of the process is the responsibility of the user.
• Do not sterilise the pencil when the electrode or extension is inserted in the tip.
• Remove the protective cap from the electrode before autoclave sterilization. After the first use,
the treatment cycle of the electrode (decontamination, sterilization) prior to re-use does not
require the re-insertion of the protective cap, which can therefore be discarded.
• In repackaging, use adequate protection systems for the tip in order to avoid perforation of the
pouch, with the consequent loss of sterility.
For sterilisation with ethylene oxide, the clean products must be packaged in suitable gas-proof
pouches. An adequate ventilation time should be respected to ensure total dispersion of the ETO
residues.
For sterilisation in an autoclave, package the products in suitable pouches.
Avoid wrapping that is too tight and sharply twisting of the cord.
Advisable temperatures and times for steam autoclave are as follows:
Cycle Pre-vacuum Exposure Drying
134°C (273°F) 8min 134°C (273°F) 2,05 bar for 12 min 9 min
121°C (250°F) 8min 121°C (250°F) 1,05 bar for 20 min 9 min
NB: The pencils can NOT be sterilised by 137°C (279 °F) cycle.
ATTENTION: Should the products come in contact with the metal supports within the autoclave, their
life may be shortened. It is therefore necessary the use of appropriate means spacing or wrapping as
gauze.
PRODUCT LIFE
The pencils, properly cleaned and sterilized, handled and stored with care, can be sterilized up to a
maximum number of sterilizations indicated on the product label.
Electrodes and extension with 2,38mm connection must be replaced after 20 sterilisations.
Electrodes with 4mm connection must be replaced after 100 sterilisations. Keep track of the number of
sterilisations performed.
PREPARATIONS AND CONNECTIONS
Attach the grounding plate to the patient, preferably on the forearm or thigh. Be sure that the skin is free
of hair and grease. Do not apply the plate to wounds or scars. Apply conductive gel to the plate (if
plates without gel are used). Passage of the current within the patient’s body should be as brief as
possible, and should proceed diagonally. The current must never flow in a transversal direction across
the body, nor cross the chest. The patient must be kept isolated from conductive parts, and the
operation table must be suitably “grounded”. Use dry gauze to avoid areas of the skin coming in contact
6 / 28
with each other. Be sure that the electrode and extension (if present) is firmly inserted into the housing
of the pencil.
Please remember to connect the electrode to the extension before connecting the extension to the
pencil. By the way, if you need to replace the electrode, remove the extension from the pencil, than
replace the electrode and finally connect again the extension to the pencil.
Connect:
• the grounding plate, by using a suitable connection cable,
• the pedal switch (for pedal-controlled models),
• the connector of the pencil cable (“active” electrode),
to the high-frequency generator.
The active cable must be kept from being in direct contact with the patient’s skin, and must not be
twisted. Always refer to the manufacturer’s instruction manual to ensure correct use of the highfrequency generator and to the instructions provided by the manufacturer of the grounding plates,
whether these are reusable or disposable.
NB: If changes are made in the patient’s position, always recheck all the connections
OPERATIONAL CHECK
Before each procedure, make a preliminary check of the functioning as follows:
1. Connect the patient to the grounding plate.
2. Connect the pencil to the electrosurgical unit.
3. Turn on the electrosurgical unit and select the 0-Watt outlet in the cutting and coagulation function.
4. Keep the pencil away from persons and objects, and activate the CUT function. Verify that
electrosurgical unit signals CUT function activation.
5. Repeat point 4 to verify the COAG function.
During the procedure, always select the lowest possible energy level. If the coagulation capacity of the
electrode is less than normal, do not increase the high-frequency output without previously carrying out
the following controls:
• the correct positioning of the grounding plate;
• the correct connection of the cables and their connectors;
• the correct activation of the starting keys (hand-switch of foot-control);
• that there is no damage to the insulation of the cables;
• that the electrode is not dirty.
POSSIBLE CAUSES OF BURNS
Burns may be caused by a high density of current in the patient’s tissues or by the heating of
inflammable fluids or gases. Possible causes are:
• The patient has inadvertently been placed in contact with electrically-conductive parts.
• A direct contact has occurred between the cables and the patient’s skin, which has caused a
capacitive effect.
• The combustion of inflammable disinfectant agents.
• The combustion of inflammable narcotic gases.
CONTRA-INDICATIONS
The products must not be utilised if:
• there is visible damage to the electrode or extension, to its insulation, to the body and/or
connector of the pencil, or to the connection cable;
• the preliminary operational check gave negative results;
• the electrode or extension is not firmly inserted in the distal part of the product.
STORAGE
The product must be stored in its original package at the environmental conditions (temperature and
relative humidity) specified on the pouch’s label. Putting external heavy weights on the package could
damage the product.
GENERAL NOTES
If a serious incident occurs while using this device or as a result of its use, please report it to the
manufacturer and to your national authority. For any malfunction or defect of the device, inform the
Manufacturer's Quality Service.
7 / 28
WASTE DISPOSAL
Waste coming from health facilities must be disposed of according to the regulation in force.
8 / 28
IT EN DE FR ES RU PT CS
2797
Conforme alla
vigente
normativa
Europea sui
Dispositivi
Medici
Dispositivo
medico
Identificativo
unico del
dispositivo
Consultare le
istruzioni d'uso
Fabbricante Manufacturer Hersteller Fabricant Fabricante
Numero di
catalogo
Compliant with
current
European
legislation on
Medical
Devices
Medical Device Medizinprodukt
Unique Device
Identifier
Consult
instructions for
use
Catalogue
number
Entspricht der
aktuellen
europäischen
Gesetzgebung für
Medizinprodukte
Einmalige
Produktkennung
Gebrauchsanweisun
g lesen
Katalognummer
Conforme à
la législation
européenne
en vigueur
sur les
dispositifs
médicaux
Dispositif
médical
Identifiant
unique des
dispositifs
Consulter les
instructions
d'utilisation
Code de
référence
Cumple con la
legislación
europea vigente
sobre dispositivos
Producto sanitario
Identificador único
del producto
Consulte las
instrucciones de
Número de
Catálogo
médicos
uso
Соответствует
действующем
у
европейскому
законодательс
тву о
медицинских
устройствах
Медицинское
устройство
Уникальный
идентификато
р устройства
Обратитесь к
инструкции по
применению
Производител
ь
Каталожный
номер
Em
conformidade
com a
legislação
europeia em
vigor sobre
Dispositivos
Médicos
Dispositivo
médico
Identificação
única do
dispositivo
Consulte as
instruções de
utilização
Fabricante Výrobce
Número de
Catálogo
Vyhovuje
současné
evropské
legislativě o
zdravotnických
prostředcích
Zdravotnický
prostředek
Jedinečným
identifikátorem
prostředku
Čtěte
uživatelskou
příručku
Katalogové
číslo
Numero di lotto Batch code Posten-Nummer
Data di
produzione
Data di
scadenza
Non riutilizzare Do not reuse
Numero
massimo di
sterilizzazioni
Non sterile Non-sterile Nicht steril Non-stérile No estériles Нестерильные Não estéril nesterilní
Limiti di
temperatura
Limiti di umidità
Proteggere
dalla luce
solare
Numero di
pezzi
Non contiene
lattice di
gomma
naturale
Date of
manufacture
Use by Verfalldatum
Maximum
number of
sterilizations
Temperature
limitation
Humidity
limitation
Keep away
from sunlight
Quantity of
pieces
Does not
contain natural
rubber latex
Herstellungsdatum
wiederverwenden
Max Anzahl der
Sterilisationen
Temperaturbereich
Feuchtigkeitsbereich
Vor Sonnenlicht
schützen
Stückzahl
Enthält kein
Naturlatex
Nicht
Numéro de
lot
Date de
production
Date de
péremption
Ne pas
reutililiser
Numero
maximum de
sterilizations
Limites de
température
Limites
d’humidité
Tenir à l’abri
de la lumière
du jour
Nombre de
pièces
Ne contient
pas de latex
de
caoutchouc
naturel
Número de Lote Код партии
Fecha de
Producción
Fecha de
Caducidad
No reutilizar
Numero maximo
de esterilizaciones
Límites de
Temperatura
Límites de
Humedad
Mantener alejado
de la luz solar
Cantidad de
piezas
No contiene
LÁTEX de goma
natural
Дата
изготовления
Использовать
до
Не
использовать
повторно
Максимальное
количество
стерилизаций
Температурны
е ограничения
Ограничения
по влажности
Беречь от
солнечных
лучей
Количество
штук
Не содержит
натурального
латекса
Número de
Lote
Data de
Fabrico
Prazo de
Validade
Não reutilizar
Número
máximo de
esterilizações
Limites de
Temperatura
Limites de
Humidade
Conservar ao
abrigo da luz
solar
Quantidade de
peças
Não contém
latex de
borracha
natural
Číslo šarže
Datum výroby
Spotřebujte do
Nepoužívat
opakovaně
max.počet
sterilizací
Omezení
teploty
Omezení
vlhkosti
Nevystavujte
slunečnému
záření
Počet kusů
Neobsahuje
přírodní latex
Via Costoli, 4 - 50039 - Vicchio
(Florence, Italy) - www.fiab.it
SpA
2797
52502395IU9B / 2022-04
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