Gima GIMA DERMATOSCOPE User guide

PROFESSIONAL MEDICAL PRODUCTS

DERMATOSCOPIO GIMA XENON ALOGENO - 10x
GIMA XENON HALOGEN DERMATOSCOPE - 10x
DERMATOSCOPE GIMA XÉNON HALOGÈNE - 10x
DERMATOSCOPIO GIMA XENON HALÓGENO - 10x
DERMATOSCÓPIO GIMA XENON HALOGÊNIO - 10X
DERMATOSCOP GIMA XENON HALOGEN - 10x
DERMATOSKOP GIMA XENON HALOGEN - 10x
GIMA XENON HALOGÉN DERMATOSZKÓP - 10x

È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito
al fabbricante e all’autorità competente dello Stato membro in cui si ha sede.

All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and
competent authority of the member state where your registered ofce is located.

Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que nous avons livré au
fabricant et à l’autorité compétente de l’état membre où on a le siège social.

Jeder schwere Unfall im Zusammenhang mit dem von uns gelieferten medizinischen Gerät muss unbedingt
dem Hersteller und der zuständigen Behörde des Mitgliedsstaats, in dem das Gerät verwendet wird, gemeldet

werden.

Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el que se encuentra
la sede sobre cualquier incidente grave que haya ocurrido en relación con el producto sanitario que le hemos

suministrado.

É necessário noticar ao fabricante e às autoridades competentes do Estado-membro onde ele está sediado
qualquer acidente grave vericado em relação ao dispositivo médico fornecido por nós.

Orice accident grav produs, privitor la dispozitivul medical fabricat de rma noastră, trebuie semnalat
producătorului și autorității competente în statul membru pe teritoriul căruia își are sediul utilizatorul.

Det är nödvändigt att meddela tillverkaren och de behöriga myndigheterna i den berörda medlemsstaten, om
alla allvarliga olyckor som inträffat i samband med den medicintekniska utrustning som levererats av oss.

A gyártónak, illetve a székhely szerinti tagállam illetékes hatóságának jelezni kell bármilyen olyan súlyos ba­lesetet, amely az általunk szállított orvostechnikai eszközzel kapcsolatban történt.

M31187-M-Rev.6-03.20

31187

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

Made in Pakistan

ENGLISH

Attention

Thank you for purchasing our Dermatoscope. The operator/user must carefully read and understand this manual
thoroughly to keep the product performance durable and reliable for longer period.
After opening the packaging, rst of all it is necessary to check all the components against the standard conguration.
Check that they are all present and in perfect conditions.

About Our Product

The Dermatoscope is used for pre-operative evaluation of cutaneous pigmented lesions with the aim of differentiating
early melanoma, which requires excision from nonmelanomatous pigmented lesions that may safely be left untreated.
The use of the Dermatoscope three-color test could reduce excision of benign melanocytic naevi, and thus prevent both
unnecessary minor surgical workload and patient morbidity.

Feature

1) Halogen Light for true tissue color.

2) Graduated skin contact plate to measure pigmented skin lesions.

3) Signicant 10X magnications.

4) This product has focal range +/- 5D (correction).

5) Focal length is 25mm.

6) Autoclavable contact plates.
This Dermatoscope is available in the reliable bayonet locking system and is equipped with a

2.5 V Xenon/halogen lamp to be powered by two 1.5 V “C” type batteries.
This Dermatoscope is packed in zipper case with vacuum formed inner tting.

Operating Instructions

Before using, it is necessary to install the battery components into the handle proceed as illustrated
in battery replacement procedure.
The Dermatoscope handle can be powered by two 1.5V “C” type batteries. Alkaline batteries

are highly recommended for optimum performance.

Place the Dermatoscope on top of the handle by aligning the slots to the ones on the handle.
Push down and twist clockwise until it locks on the handle.
Push the white button on the handle and twist the black knob towards the left hand side. The
unit is now in operation.
The intensity of the light can be adjusted by turning the knob clockwise or counter clockwise.

Gently rest the contact plate on the lesion such that the lesion is in the center of the contact

plate and examine for its surface structure. To reduce glare from stratum conneum, apply oil
(Mineral oil, Petroleum Jelly, etc).
With your index nger on the Rubber Focusing Ring, adjust for optimal focus while your eye is
resting on the Rubber Eye Guard.
Observe the illuminated and magnied lesions, making notes for treatment.
To measure pigmented skin lesions, the graduated contact plate must be used.
Switch of the unit after use to preserve batteries. Twist the black knob towards right until an
audible click sound is heard once the button comes to its off position.

Care and Maintenance

Periodically check the battery conditions, making sure that no sign of corrosion or oxidation is

present.

Cleaning and Sterilization

Contact Plate

The contact plate must be taken off after each examination.
The contact plate can withstand cleaning or disinfection by soaking in alcohol solution, cidex, etc.
The contact plate can also be autoclaved up to 135º C and Pressure of 28 p.s.i.

Lens

The lens can be cleaned by using a moistened cotton-tipped
applicator with alcohol or a solution of water with mild detergent.
Do not use abrasive materials to clean the lenses as they will scratch

the coated surface of the lenses.
Handle

The handle can be cleaned with a moist cloth.
Battery handle shall not be dipped into water. Remove battery
components while cleaning

Fig.1

Contact Plate

4

Fig.2

5

Lamp Replacement Procedure

Before removing the lamp, make sure that the device has been turned off for some minutes other wise you
run the risk of being burnt. Lamps may be hot. So it’s necessary to let it cool.

Remove Dermatoscope head from the power source as advised in
operating instructions (See g.1).
Pull out lamp with nail le or similar tool (if necessary) by getting it under
the base of lamp (See g.3).
Use recommended lamp for replacement by carefully aligning pin on lamp
shaft with slot in Dermatoscope head. Push the lamp until seated well.

Clean the contact plate with cleaning solution prior to
autoclaving.

Battery Replacement Procedure

In case of necessity replacement of new batteries then carefully handle
the batteries as the liquid in a leaking battery can irritate skin and eyes.

While replacing batteries it is necessary to use exclusive
alkaline type batteries.

a) Open the battery compartment, to do this, turn the end cap counter

clock wise.

b) Once opened, insert the batteries paying attention to the direction of

poles (See g 1).

c) To close the battery compartment, screw down the cap clock wise and

check that the batteries are in contact with poles.

Storage

Since the product is made of corrosion-proof materials suitable for environmental conditions foreseen for its normal
use, it does not require special care. However it is necessary to store it in a closed place making sure that is protected
from dust and dirt to assure it’s hygienic properties. Store in clean environment and preserve in normal temperature.

Precautions

Dermatoscope is equipped with halogen lamp and shall be used exclusively with alkaline batteries type “C”
correctly installed.

This shall be used by qualied medical personnel only.

Don’t use the equipment in case it is damaged. Apply to your retailer.
If the instrument has rusted then don’t use it.
Avoid precarious repairs.
Repairs shall be carried out with original spare parts only, which shall be installed according to the intended use.
Protect lamp surface against abrasions and scratches.

ENGLISH

Fig.3

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.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

IT Attenzione: Leggere e seguire attentamente

le istruzioni (avvertenze) per l’uso

GB Caution: read instructions (warnings) carefully

FR Attention: lisez attentivement les instructions (aver­tissements)
DE Achtung: Anweisungen (Warnungen) sorgfältig lesen
ES Precaución: lea las instrucciones
(advertencias) cuidadosamente

PT Cuidado: leia as instruções (avisos) cuidadosamente
RO Atenție: Citiți și respectați cu atenție instrucțiunile

(avertismentele) de utilizare

SE Varsamhet: läs anvisningarna (varningar) noga
HU Figyelem: Figyelmesen olvassa el és kövesse a

használati utasításokat (gyelmeztetéseket)

IT Conservare in luogo fresco ed asciutto

GB Keep in a cool, dry place

FR Á conserver dans un endroit frais et sec
DE An einem kühlen und trockenen Ort lagern

ES Conservar en un lugar fresco y seco

PT Armazenar em local fresco e seco
RO A se păstra într-un loc răcoros și uscat

SE Förvara på svalt och torrt ställe
HU Száraz, hűvös helyen tárolandó

IT Fabbricante

GB Manufacturer

FR Fabricant
DE Hersteller

ES Fabricante

PT Fabricante
RO Producător

SE Tillverkare
HU Gyártó

IT Codice prodotto

GB Product code

FR Code produit
DE Erzeugniscode

ES Código producto

PT Código produto
RO Cod produs

SE Produktkod
HU Termékkód

IT Seguire le istruzioni per l’uso

GB Follow instructions for use

FR Suivez les instructions d’utilisation
DE Folgen Sie den Anweisungen

ES Siga las instrucciones de uso

PT Siga as instruções de uso
RO Respectați instrucțiunile de utilizare

SE Följ bruksanvisningen
HU Kövesse a használati utasításokat

IT Smaltimento RAEE

GB WEEE disposal

FR Disposition DEEE
DE Beseitigung WEEE

ES Disposición WEEE

PT Disposição REEE
PL Oddzielna zbiórka dla tego urządzenia
RO Eliminare DEEE

SE Avfallshantering av elektrisk och elektronisk
utrustning (WEEE)
HU RAEE szerinti ártalmatlanítás

18

IT Dispositivo medico conforme al regolamento
(UE) 2017/745
GB Medical Device compliant with Regulation
(EU) 2017/745
FR Dispositif médical conforme au règlement
(UE) 2017/745
DE Medizinprodukt im Sinne der Verordnung
(EU) 2017/745
ES Producto sanitario conforme con el reglamento
(UE) 2017/745
PT Dispositivo médico em conformidade
com a regulamento (UE) 2017/745
RO Dispozitiv medical realizat în conformitate
cu prevederile regulamentul (UE) 2017/745
SE Den medicintekniska produkten överensstämmer
med förordning (EU) 2017/745

HU A 2017/745/EU rendeletnek megfelelő

orvostechnikai eszköz
IT Conservare al riparo dalla luce solare

GB Keep away from sunlight

FR Á conserver à l’abri de la lumière du soleil
DE Vor Sonneneinstrahlung geschützt lagern

ES Conservar al amparo de la luz solar

PT Guardar ao abrigo da luz solar
RO A se păstra ferit de razele soarelui

SE Skyddas från solljus
HU Napfénytől védve tárolandó

IT Data di fabbricazione

GB Date of manufacture

FR Date de fabrication
DE Herstellungsdatum

ES Fecha de fabricación

PT Data de fabrico
RO Data fabricației

SE Tillverkningsdatum
HU Gyártás dátuma

IT Numero di lotto

GB Lot number

FR Numéro de lot
DE Chargennummer

ES Número de lote

PT Número de lote
RO Număr de lot

SE Satsnummer
HU Tételszám

IT Parte applicata di tipo B

GB Type B applied part

FR Appareil de type B
DE Gerätetyp B

ES Aparato de tipo B

PT Aparelho de tipo B
RO Componentă aplicată de tip B

SE Typ B tillämpad del
HU B típusú alkalmazott rész

IT Dispositivo medico

GB Medical Device

FR Dispositif médical
DE Medizinprodukt

ES Producto sanitario

PT Dispositivo médico
PL Wyrób medyczny
RO Dispozitiv medical

SE Medicinteknisk produkt
HU Orvostechnikai eszköz