Gima 30939 User manual

PROFESSIONAL MEDICAL PRODUCTS
M30939-M-Rev.0-04.22
NUOVA LAMPADA FRONTALE LED GIMA
NEW GIMA LED HEAD LIGHT
NOUVELLE LAMPE FRONTALE À LED GIMA
DIE NEUE GIMA STIRNLAMPE
NUEVO FARO LED GIMA
NOVA LANTERNA DE CABEÇA LED GIMA
ΝΕΟΣ ΦΑΚΟΣ ΚΕΦΑΛΗΣ LED GIMA
Non utilizzare il prodotto a contatto diretto con la pelle ma utilizzare sempre con opportuna protezione.
Do not use the product in direct contact with skin. Use suitable protection.
Ne pas utiliser le produit en contact direct avec la peau mais utiliser toujours une protection adéquate.
Verwenden Sie das Produkt nicht mit bloßen Händen, tragen Sie immer eine geeignete persönliche Schutzausrüstung,
damit das Produkt nicht auf die Haut kommt.
No utilice el producto en contacto directo con la piel, úselo siempre con una protección adecuada.
Não utilize o produto em contacto direto com a pele, ao invés, utilize sempre com a proteção apropriada.
Μη χρησιμοποιείτε το προϊόν σε άμεση επαφή με το δέρμα αλλά χρησιμοποιείτε το πάντα με κατάλληλη
προστασία.
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbri-
cante 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 Her-
steller 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.
Σε περίπτωση που διαπιστώσετε οποιοδήποτε σοβαρό περιστατικό σε σχέση με την ιατρική συσκευή που σας
παρέχουμε θα πρέπει να το αναφέρετε στον κατασκευαστή και στην αρμόδια αρχή του κράτους μέλους στο
οποίο βρίσκεστε.
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in China
30939
ﻻ ﺗﺴﺘﻌﻤﻞ ا ﻟﻤﻨ ﺘﺞ ﻋﻠﻰ ا ﺗﺼﺎل ﻣﺒ ﺎﺷﺮ ﻋﻠﻰ ا ﻟﺠﻠﺪ وﻟﻜﻦ ﯾﺠﺐ اﺳﺘﻌﻤﺎ ﻟﮫ ﻣﻊ ا ﻟﺤﻤﺎ ﯾﺔ ا ﻟﻤﻨ ﺎﺳﺒﺔ.
ﯾﺠﺐ اﻹﺑﻼغ ﻓﻮرا ﻋﻦ أي ﺣﺎدث ﺧﻄﯿﺮ وﻗﻊ ﻓﯿﻤﺎ ﯾﺘﻌﻠﻖ ﺑﺎﻟﺠﮭﺎز اﻟﻄﺒﻲ اﻟﺬي زودﻧﺎ ﺑﮫ إﻟﻰ اﻟﺠﮭﺔ اﻟﺼﺎﻧﻌﺔ واﻟﺴﻠﻄﺔ اﻟﻤﺨﺘﺼﺔ ﻓﻲ اﻟﺪوﻟﺔ اﻟﻌﻀﻮ
ا ﻟ ﺘﻲ ﯾ ﻘﻊ ﻓ ﯿ ﮭ ﺎ .
90%
10%
1060 hPa
500 hPa
+55°C
-40°C

5ITALIANO
Thank you for purchasing this product. To prevent damage to your product or injury to yourself or to others, read the
following safety precaution in their entirety before using this equipment. Keep these safety instructions where all those
who use the product will read them.
Symbols:
Internal electrical power source
Illumination adjustment mark
Class II
Cautions
1. Read this article for Cautions and instructions for use.
2. Do not use this instrument in damp rooms. Do not expose the instrument to water splashes, dripping water or spra-
yed water.
3. This product must not be used in the presence of ammable gases.
4. Do not shine the light directly into the eyes.
5. Ensure that the headband power cord is located in the clips provided. The headlight body should not be left covered
with a cloth or similar.
6. Please use special certicated adapter.
7. Never scratch the glass cover with ngers or any other hard materials.
8. Federal law restricts this device to sale or order of a physician.
1. Purpose and Features of the product
1.1 Purpose
Headlight 30939 is used for examination and surgical operation in multifarious microsurgery.
1.2 Features
• Light Source: LED source with color temperature of 5000 K. White, shadow-free light allowing the doctor to see tissue
characteristics without distortion.
• Enjoy the exibility of operating the headlight using the rechargeable Lithium battery, can use without the direct power
source. It is one of the most comfortable lightweight headlights and suitable for all kinds of surgery.
• The headlight could be used when it is charging.
• Battery indicator lights.
• Adapts to any Binocular Loupes of Gima.
• Smart design, convenient for mobile diagnosis.
2. Operating Instructions
Attach the power cord by means of the clip provided. Place the device on your head and adjust for width and height to
that it ts comfortably.
Connect the Headlight to the power adapter. Use the headband right or left brightness control knob to select the required
brightness.
Loosen the xing screw to adjust the light head up and down and backwards or forwards. After adjustment, retighten the
screw. The illuminated eld of view can be selected by means of the slide control.
3. Maintenance
Caution: Qualied trained professional persons are needed to maintenance the product. Please contact with
authorized dealer or manufacture.
3.1 Battery charging and replacing
3.1.1 Battery case is charged
Battery box (hereinafter referred to as the battery) yellow light, prompted to charge or replace as soon as possible
to recharge the battery backup. If the power indicator only yellow light and continue to use, the battery will start self-
protection, cut off the power to prevent the battery over-discharge.
When charging, connect one end of the power adapter output line to the round hole on the side of the battery, and
the power adapter is plugged into the network power socket. At this point the charging indicator will ash from yellow
to green followed by charging. Charging lights are all off, indicating that the battery is full. When charging, the headset
inspection lamp can continue to use.
ENGLISH

6
ENGLISH
3.2 Battery use and care
The capacity of Lithium battery will be changed by it’s using condition. For maximum battery capacity, use the battery
in room temperature(10 ℃~40 ℃). Do not expose the battery to extreme temperatures, if the battery is used in high or
low temperatures, the battery capacity will be reduced.
3.3 Cleaning and sterilization
• The outer surface of the instrument may be cleaned with wet cloth, the remaining stains can be cleaned off with the
mixture of 50% alcohol and 50% distilled water. Do not wipe with any corrosive detergent lest that the surface should
be damaged.
• Cleaning the lenses: Mirror-cleaning paper or a drop of liquid solvent (50% alcohol and 50% aether) may be used to
clean the lens, blow it carefully. If there is dust stained on the lens, blow them with a blowball or brush them with a
dust pen.
Caution: Be careful to prevent the solvent into the device.
4. Installation
4.1 Installing the battery into the headband
Installing as shown in below picture, the battery cartridge into the adjusting knob cover, then rotate along time until the
level stops. Removing, counter-clockwise rotation to 90 degree position and then pull it out.
There are two types of battery installation, respectively, up or back.
5. Technical Specication
Optical specications
illumination light spot at 420mm 20~80 mm
Illumination in 200mm working distance ≥ 75000 lx
Adjustable range
Fluctuation distance ≥12.5 mm
Angle range Vertical ±25°
Weight
Headlight ( excluding head band) 69 g
Option parts Red color lter
Electrical specications
Illumination Source 5W LED, life 20000 hours continuous burn, do not need to chan-
ge the LED lamp.
Electrical Safety EN60601-1,EN60601-1-2 Class II and internal electrical power
source
Accessories
Battery 7.4 V Recharged Lithium battery (4400mAh)
Power adapter input voltage 100VAC ~ 240VAC, 50Hz or 60Hz.
Power adapter Output voltage and power Output voltage 12 V, maximum input power ≤ 30 VA
Battery Run-time ≥7 h (Maximum luminance)
Battery Charging-time ≤5 h
Protection Short circuit protection, power protection and over current
protection.
Environment requirements
Operation Temperature +10 ℃- +40 ℃
Rel. humidity 30% - 75%
Air pressure 700 hPa - 1060 hPa
Storage Temperature -40 ℃ - +55 ℃
Rel. humidity 10% - 90%
Air pressure 500 hPa - 1060 hPa

7ENGLISH
Caution: read instructions (warnings) carefully Follow instructions for use
Medical Device compliant with Regulation (EU)
2017/745
Date of manufacture
Keep away from sunlight Keep in a cool, dry place
Product code Lot number
WEEE disposal Class II applied
Internal electrical power source Medical Device
Temperature Limitation
%
Humidity Limitation
Atmospheric Pressure Limitation
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 specific recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.