Gima 30598 Manuale del proprietario

Gima
Marca
Gima
Modello
30598
Tipo
Manuale del proprietario
52502442IU5B
2022-03 2797 Via Costoli, 4 - Vicchio (Florence, Italy) - www.fiab.it Pag. 1
REUSABLE ELECTROCAUTERY
TIP FOR REUSABLE ELECTROCAUTERY
DIRECTIONS FOR USE
INDICATIONS
Cauterisation of tissues and small blood vessels during surgical
operations. No high frequency generator is required. Specially
suitable for ambulatory care surgery.
DESCRIPTION
F7297 and F7299 are reuasable electrocauteries wich allows
batteries and tip replacement. Inserting a disposable sterile tip
(F7298 series) on the anterior part, reusable electrocautery
becomes a self-powered system for cauterisation of small
vessels, and it provides an excellent alternative to the radio
frequency electrosugcial unit. F7297 and F7299 cauteries are
intended for different fields of application: F7297 is specific for
oftalmology, while F7299 can be used for gynaecology,
orthopedics, Othorinolaringoiatry, urology e dermatology.
Anyhow, they can be both used in specialities where an
accurate and quick cauterisation is required. Since
electrocautery body is supplied non-sterile (only tips are sterile)
these models can be used for ambulatoriali procedures only.
Tips are supplied with a sterile protection sheat in PE, which
must be used to protect electrocautery body when in use.
Depending on the needing, three different tips can be supplied:
fine long (F7298FG), fine short (F7298F) and fine large
(F7298L). F7297 cautery must be used with the fine short one
(F7298). The Working temperatures reach 600°C/1100°F for
F7297 cautery 1.200°C/2200°F for F7299 cautery.
WARNING
•Power is supplied by batteries.
•Use only alkaline batteries SIZE AA 1,5V LR6.
•It is advisable to replace batteries after every application.
•The tips, and the supplied protections, are single-use and
sterilized with ethylene oxide gas – do not reuse – Reusing
the product may lead to:
oPossible presence of biological residues that may cause
cross-infections;
oAlteration of materials;
oLoss of initial functional features of product;
•The tips and protections may not be sterile if the package
has been opened and/or damaged.
•After having controlled that packaging is not damaged,
verify cautery body; in case of visible damages or defects,
do not use the product and send it back to FIAB.
•Avoid direct contact of cautery with liquids.
•To clean the body use only water-based disinfectants
(containing no alcohol).
•Do not sterilise with steam.
•The body has a safety cap-closing system guaranteeing
protection when the tip is not inserted.
•The equipment is to be prepared and used by specialized
personnel.
•Avoid use in presence of flammable anaesthetic
products and mixtures.
•Replace the protection when replacing the tip.
•After use always reinsert protection cap before disposal .
•If needed, the body may be sterilized (without tip and
batteries) with ethylene oxide for up to 10 times (validation
of sterilization is under the responsability of each end user).
After sterilization, the end user should operate in order to
avoid any contamination in replacing batteries.
•As concerns disposal, please follow what explained at the
paragraph “DISPOSAL”.
Caution: remove the tip when the equipment is not used or it
may cause a fire.
PREPARATION AND USE
•Open the package containing the tip.
•Extract the protection cap from the handle by making it slide
in parallel to the long axis.
•Insert the transparent protection (Fig. 1) on the stem,
inserting the handle between the white strip and the paper,
thus protecting the tip lodgings.
•Remove the protection package.
•Insert the tip on the front of the stem, piercing the
transparent protection.
•For a preliminary control of the electrocautery, follow these
instructions:
oKeep the equipment far from things or people, and press
the start button;
oMake sure the tip becomes incandescent;
NB As concerns the low temperature model, since its tip
does not become incandescent, you can verify the right
functioning as follows: press start button and touch a wet
gauze (wet with sterile water or saline solution), then wait
2/3 seconds before noticing water evaporation;
o If needed, replace the batteries (see corresponding
paragraph);
•When using the equipment on the patient, make short (2-3
seconds) and repeated applications. Do not keep the
equipment on for too long.
•Do not exert pressures that may misshape the tip.
•Once the application is over, remove the tip from the
handle, remove the transparent protection and throw away;
if needed, clean the handle and insert the cap.
EN
Fig.1
52502442IU5B
2022-03 2797 Via Costoli, 4 - Vicchio (Florence, Italy) - www.fiab.it Pag. 2
•If the stem protection is not used during applications, there
is the risk of infections since the stem is not sterile.
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.
WASTE DISPOSAL
Waste coming from health facilities must be disposed of
according to the regulation in force.
The batteries must be disposed of in line with current
regulations. Do not burn batteries.
REPLACING BATTERIES
To replace the batteries, press the cap at the bottom of the
handle, turn clockwise and pull it out. Replace the batteries,
inserting them with the positive pole towards the inside of the
handle. Put the cap back in place by pressing it and turning it
anticlockwise until it stops.
CONTRAINDICATIONS
•F7299: Don’t use for intra-ocular applications.
•The electro-cauteries are not suitable to cauterize heavy
haemorrhages.
52502442IU5B
2022-03 2797 Via Costoli, 4 - Vicchio (Florence, Italy) - www.fiab.it Pag. 3
IT EN FR ES DE RU
2797
Conforme alla
vigente normativa
Europea sui
Dispositivi Medici
Compliant with
current European
legislation on
Medical Devices
Conforme à la
législation européenne
en vigueur sur les
dispositifs médicaux
Cumple con la
legislación europea
vigente sobre
dispositivos
médicos
Entspricht der
aktuellen
europäischen
Gesetzgebung für
Medizinprodukte
Соответствует
действующему
европейскому
законодательству о
медицинских
устройствах
Dispositivo medico Medical Device Dispositif médical Producto sanitario Medizinprodukt Медицинское
устройство
Identificativo unico
del dispositivo
Unique Device
Identifier
Identifiant unique
des dispositifs
Identificador único
del producto
Einmalige
Produktkennung
Уникальный
идентификатор
устройства
Attenzione Caution Attention Precaución Vorsicht Предостережения
Consultare le
istruzioni d'uso
Consult instructions
for use
Consulter les
instructions
d'utilisation
Consulte las
instrucciones de
uso
Gebrauchsanweisung
lesen
Обратитесь к
инструкции по
применению
Seguire le istruzioni
per l’uso
Follow instructions
for use
Consulter les
instructions avant
utilisation
Siga las
instrucciones de
uso
Befolgen Sie die
Gebrauchsanweisung
Следуйте
инструкциям по
применению
Numero di catalogo Catalogue number Code de référence Número de
Catálogo Katalognummer Каталожный номер
Numero di lotto Batch code Numéro de lot Número de Lote Posten-Nummer Код партии
Data di produzione Date of manufacture Date de production Fecha de
Producción Herstellungsdatum Дата изготовления
Data di scadenza Use by Date de péremption Fecha de
Caducidad Verfalldatum Использовать до
Fabbricante Manufacturer Fabricant Fabricante Hersteller Производитель
Limiti di temperatura Temperature
limitation
Limites de
température
Límites de
Temperatura Temperaturbereich Температурные
ограничения
Limiti di umidità Humidity limitation Limites d’humidité Límites de
Humedad Feuchtigkeitsbereich Ограничения по
влажности
Proteggere dalla
luce solare
Keep away from
sunlight
Tenir à l’abri de la
lumière du jour
Mantener alejado
de la luz solar
Vor Sonnenlicht
schützen
Беречь от
солнечных лучей
Sterilizzato con
ossido di etilene
Sterilized using
ethylene oxide
Stérilisé à l’oxyde
d’éthylène
Esterilizado con
oxido de etileno
Sterilisiert mit
Ethylenoxid
Стерилизовано с
использованием
окида этилена
Sistema di barriera
sterile singola Single sterile barrier
system Système de barrière
stérile unique Sistema de barrera
estéril simple Einfaches steriles
Barrierensystem Единая стерильная
барьерная система
Non usare se la
confezione è
danneggiata
Do not use if
package is
damaged
Ne pas utiliser si
l'emballage est
endommagé
No utilizar si el bulto
está dañado
Bitte nicht benutzen wenn
die Verpackung
beschädigt ist.
Не использовать,
если упаковка
повреждена
Non risterilizzare Do not resterilize Ne pas restérilisér No esterilizar
nuevamente
Nicht wieder
sterilisieren
Не стерилизовать
повторно
Non riutilizzare Do not reuse Ne pas reutililiser No reutilizar Nicht
wiederverwenden
Не использовать
повторно
Dispositivo di tipo
CF Type CF device Appareil de type CF Aparato de tipo CF Geräte vom Typ CF Устройства CF-
типа
Numero di pezzi Quantity of pieces Nombre de pièces Cantidad de piezas Stückzahl Количество штук
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Gima 30598 Manuale del proprietario

Gima
Marca
Gima
Modello
30598
Tipo
Manuale del proprietario
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