Gima Sigma 31524 Parts list manual

M31524-M-Rev.1.03.18
Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. [phone] - fax [phone]
Export: tel. [phone]/221/225 fax [phone]
[e-mail] - [e-mail]
www.gimaitaly.com EU Repre-
sentative
Otoscopio F.O. Sigma
Sigma F.O. Otoscope
Otoscope Sigma F.O.
Sigma F.O. Otoskop
Sigma F.O. Otoscopio
Sigma F.O. Otoscópio
Σίγμα Φ.Ο Ωτοσκόπιο
MANUALE D’USO E MANUTENZIONE
USE AND MAINTENANCE BOOK
INSTRUCTIONS DE FONCIONNEMENT ET ENTRETIEN
BETRIEBS UND WARTUNGS ANWEISUNGEN
MANUAL DE USO Y MANTENIMIENTO
MANUAL DE USO E MANUTENÇÃO
ΕΓΧΕΙΡΙΔΙΟ ΧΡΗΣΗΣ ΚΑΙ ΣΥΝΤΗΡΗΣΗΣ
ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand the present
manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.
ACHTUNG: Die Bediener müssen vorher dieses Handbuch gelesen und verstanden
haben, bevor sie das Produkt benutzen.
ATENCIÓN: Los operadores tienen que leer y entender completamente este manual
antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes
de usar o produto.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
Sigma F.Oﻥﺫﻷﺍ ﺭﺎﻅﻧﻣ .
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in U.A.E.
31524 - 31523 - 31525
31526 - 31518
Fabbricante
Manufacturer
Teme l’umidità
Keep dry
Conservare al riparo della luce
solare diretta
Keep away from sunlight
Apparecchio di Tipo B
Type B device

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Dettagli prodotto
1Testa dell’otoscopio
2Finestra d’ingrandimento
3 Portainsu󰀪azionearia
4 Interruttoreon/o󰀨
5Manico
6Tappo
7Speculum monouso
8 Speculumriutilizzabile
9 Adattatoreinsu󰀪azione
10 Pompettainsu󰀪azione
Produktdetails
1 Otoskop-Kopf
2 Vergrößerungsfenster
3 Gebläseanschluss
4 On-/O󰀨-Schalter
5 Handgri󰀨
6 Verschlusskappe
7 Einweg-Ohrtrichter
8 Wiederverwendbarer
Ohrtrichter
9 Gebläseadapter
10 Pumpball
Product Detail
1Otoscope head
2 Magnicationwindow
3 Insuationport
4 On/O󰀨switch
5Handle
6End cap
7Disposable ear tip
8Reusable ear tip
9 Insuationadaptor
10 Insuationbulb
Detalles del producto
1 Cabezaldelotoscopio
2Ventana de aumento
3 Puertodeinsuación
4Interruptor de encendido/
apagado
5Mango
6Tapa inferior
7Espéculo auricular
desechable
8Espéculo auricular
 reutilizable
9 Adaptadordeinsuación
10 Balóndeinsuación
Détails de l’instrument
1Tête otoscope
2Fenêtre d’observation
grossissante
3 Raccorddesou󰀪erie
4 InterrupteurOn/O󰀨
5Manche
6Bouchon
7Spéculums à usage unique
8Spéculums réutilisables
9 Adaptateurinsu󰀪ation
10 Poired’insu󰀪ation
Detalhe do Produto
1 Cabeçadootoscópio
2 Janelademagnicação
3Porta de sopro
4 InterruptorOn/O󰀨
5Cabo
6Tampa
7Ponta para orelha
descartável
8Ponta para orelha
 reutilizável
9Adaptador do soprador
10 Bomba de sopro
1
2
3
4
5
6
7
10
9
8
Fig-1

3
ﺞﺘﻨﻤﻟﺍ ﻞﻴﺻﺎﻔﺗ
1
ﺭﺎﻈﻨﻤﻟﺍ ﺱﺃﺭ
2
ﺮﻴﺒﻜﺘﻟﺍ ﺓﺬﻓﺎﻧ
3
ﺦﻔﻨﻟﺍ ﺔﺤﺘﻓ
4
ﻑﺎﻘﻳﻹﺍ /ﻞﻴﻐﺸﺘﻟﺍ ﺡﺎﺘﻔﻣ
5
ﺾﺒﻘﻤﻟﺍ
6
ﺱﺄﻜﻟﺍ ﺔﻳﺎﻬﻧ
7
ﺓﺪﺣﺍﻭ ﺓﺮﻣ ﻡﺍﺪﺨﺘﺳﻼﻟ ﻥﺫﻸﻟ ﻑﺮﻁ
8
ﺩﺎﻌﻳ ﻥﺫﻸﻟ ﻑﺮﻁﻪﻣﺍﺪﺨﺘﺳﺍ
9
ﺦﻔﻨﻟﺍ ﻢﻈﻨﻣ
10ﺦﻔﻧﻟﺍ ﺔﺑﻭﺑﻧﺃ
Λεπτομέρεια Προϊόντος
1 Κεφαλήωτοσκοπίου
2 Παράθυρομεγέθυνσης
3 Θύραεμφύσησης
4 Διακόπτηςενεργοποίησης/
 απενεργοποίησης
5 Λαβή
6 Τελικόπώμα
7 Αναλώσιμοςκώνος
8 Επαναχρησιμοποιημένος
 κώνος
9 Προσαρμογείς
 εμφύσησης
10Λαμπτήραεμφύσησης
OFF
ON
A
B
CFig-2
Fig-3
Lock
1
Fig-4
Led
Fig-6
Insufflation Bulb
connecting with
Adaptor.
Insufflation
Bulb.
Adaptor
Fig-7
Peeloff
Protectivesheet
Lens Locking Point
Fig-5

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Instructions For Use
The operating and maintenance instructions found in this manual should be followed to ensure
years of reliable service.
Please read these instructions carefully before using the Sigma and keep them in a safe
place for future or use reference.
Intended Use
Sigma Otoscopes and associated accessories are intended for the examination of ear, the
external auditory canal and the eardrum.
This instrument has an optical magnifying lens and battery-powered illumination handle, and
recommendedforusebymedicallyqualiedpersonneltoassessthehealthofearthrough
transmitting light into the ear canal.
This device is intended for transit treatment and examination.
Setting Up the Product
Head & Handle Attachment
To setup the Sigma Otoscope, align the otoscope thread with handle and rotate the head
clockwiseuntilheadandhandlermlyjoined.(Fig-2,A)
Sigma Battery Handle
The Sigma battery handle should only be used as a power source for Sigma instruments.
Grip the handle attached to Otoscope head. To turn ON the light, slide the switch with thumb
towards the bottom of the handle.
To turn OFF the light, slide the switch with thumb towards the top of the handle. (Fig-2, B)
Insert Batteries
Arrange twoAA/LR6 size good quality alkaline batteries for power. Rotate end cap
counterclockwise to open the handle end cap. Insert two batteries into handle with positive
(+) terminal towards the head and close the cap by rotating clockwise (Fig-2, C).
Note: Batteries are not included in sets.
The Otoscope is intended for transit treatment and the handle may gets warm by longer use.
So let it be cool down before next application.
Aharmlessmaxtemperatureof60°Cwillnotbeexceeded.
Sigma xenon otoscope model
Bulb Replacement
Rotate otoscope head counterclockwise to detach from handle.
Pull down the bulb and insert new bulb into socket and rotate the head clockwise until head
andhandlermlyjoined(Fig-3).
Before replacing the bulb read below instruction carefully.
Let the device cool down before changing the bulb.
Verify the bulb voltage / specication before changing.
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9
Operating
SigmaOtoscopeshouldonlybeinsertedintotheauditorycanalwhenaeartipistted.Place
theeartipontheotoscopeinsuchawaytheprojectioninsidetheeartiptsintotheslit(Fig-
4,1) and tighten the ear tip by twisting it slightly to the right.
Do not use otoscope without ear tip that may cause ear injury and / or cross
contamination.
Do not reuse disposable ear tip that may result in contamination from one patient
to another patient.
Do not point light in patient eyes that may cause eye injury.
Do not use excess force while locking the ear tip on head.
Magnifying Lens
SigmaOtoscopehas3xmagnicationthatproducesdistortion-freeimagesoftheexamined
object.Themagnicationviewingwindowispermanentlyattachedandcanbeswivelledaside
for instrumentation. To facilitate the instrumentation rotate the viewing window clockwise as
much as required (Fig-5).
Peel o the lens protective sheet before use (Fig-5)
Sigma LED otoscope model
TheLEDxedandsealedintotheotoscopeheadandcannotbechangedbecauseofits
long life.
LED has 50,000 hours of extended lifetime.
Ensure no replacement of LED ever in the lifetime of the instrument.
Excellentlightoutputof85KLUX.
Extended battery life of 50 HOURS due to low current consumption of LED.
With a colour temperature of 5500K and CRI>80 colours are visible as they are.
Ear Tip
Ear tip is used in otoscope as viewing passage for direct examination of the external acoustic
duct and tympanic membrane.
ChoosethesizeofEartipsuitablefortheexaminationoftheacousticduct.
Insu󰀪ation Port (optional)
Sigma Otoscope have a connection port to facilitate the tympanic mobility test (Fig-7).
This can be carried out when the viewing window is closed by using optionally available
insu󰀪ationbulbandadaptor.
Dose the pressure carefully with the insuation bulb.
Cleaning / Sterilization and Maintenance
The Sigma F.O. Pocket otoscope is not suitable for treatment in the ultrasonic bath, for
sterilization,spraydisinfectionortreatmentbyimmersioninliquids.
Manual Cleaning Process
Use a damp cloth for cleaning the Sigma pocket otoscope.
For cleaning and disinfection, a disinfectant agent suitable for plastic medical products must
be used.
ENGLISH

10ENGLISH
Handle Cleaning
The handle can be cleaned with a cloth soaked with disinfectant, however it cannot be dipped
into liquids.
Do not use the equipment in case it is damaged. Apply to your retailer.
Periodically check the battery conditions, making sure that no sign of corrosion of oxidation
is present. In case of necessity replace them with new alkaline ones.
Carefully handle the batteries as the liquids they contain can irritate skin and eyes.
Before being used, thoroughly check the product. The same operation shall be carried out
after cleaning.
CheckthattheconnectionbetweentheheadandthehandleisperfectandthattheOn/O󰀨
button works correctly.
If the light is intermittent or in case it does not turn on, Check the bulb, the batteries and the
electrical contacts.
Precautions
Read the label before losing packing. Do not use if packaging has been open or
damaged. Only qualied person should use it.
Handle the device with care and keep the instrument away from the range of
insects and rodents.
Autoclaving is not permissible for this type of handle.
Ultrasonic cleaning is not recommended.
Store the device in clean environment at normal temperature.
Please ensure that the batteries, Handles and Ear Tips and other Sub-assemblies
are discarded as clinical waste in accordance with local policies.
In accordance with local regulations this product should be disposed of as an
electronic device separately.
Transport and Storage
Before transporting the appliance, make sure that it is correctly packaged ensuring also that
there are no risks of shocks bumps or falls during the transport itself.
Damage to the appliance caused during transport and handling is not covered by the guarantee.
The device must be stored in a dry, Cool area away from direct sunlight.
It must not be placed in contact with any substances or chemical agents which could cause
damage and reduce safety characteristics.
Operation
Temperature 10°C-40°C
Humidity 30% - 75%
Air Pressure 700 hPa - 1060 hPa
Storage & Transport
Temperature -20°C-70°C
Humidity 10% - 90%
(without condensation)
Air Pressure 500 hPa - 1060 hPa

11 ENGLISH
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling
point for electric and electronic equipment.
For further information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the equipment
is not disposed of correctly, nes or penalties may be applied in accordance with
the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product.
This product meets high qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free of charge all
the defected parts due to production reasons. Labor costs and personnel traveling expenses
and packaging not included.
Allcomponentssubjecttoweararenotincludedinthewarranty.
The repair or replacement performed during the warranty period shall not extend the warranty.
Thewarrantyisvoidinthefollowingcases:repairsperformedbyunauthorizedpersonnelor
with non-original spare parts, defects caused by negligence or incorrect use.
GIMA cannot be held responsible for malfunctioning on electronic devices or software due
tooutsideagentssuchas:voltagechanges,electro-magneticelds,radiointerferences,etc.
The warranty is void if the above regulations are not observed and if the serial code (if available)
has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was purchased from.
ProductssenttoGIMAwillberejected.

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