Gima VISIO 2000 F.O.XENON OTOSCOPE User guide

PROFESSIONAL MEDICAL PRODUCTS

OTOSCOPIO F.O. XENON VISIO 2000 - 3,5V
VISIO 2000 F.O.XENON OTOSCOPE - 3.5V
OTOSCOPE F.O. XÉNON VISIO 2000 - 3,5V
OTOSCOPIO F.O. XENÓN VISIO 2000 - 3,5 V

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.

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.

31535

Gima S.p.A.

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

www.gimaitaly.com

M31535-M-Rev.3-03.20

Made in Pakistan

F

2

A

A

G

B

C

Fig.1

D

Fig.2

3

A

Barrel

rechargeable
li-ion battery 3.5V

Fig.3

End-cap

(E)

Locking cap

ENGLISH

OTOSCOPE

The Otoscope is designed to examine the external ear and for general non-invasive examination.

Features

- Made from Impact Resistant re-enforced plastic and highly reliable corrosion resistant stainless steel.

- Easy replacement of lamp.

- Distal bre optic illumination with super bright 3.5V Xenon/Halogen.

- Insufation port pneumatic testing of tympanic mobility.

- Swivel type window with 3x Magnication lense for sharp images and minimal Reection.

The Otoscope should only be used to examine the ear when a tip is tted.
Pressure should be applied with great care when doing pneumatic testing.

OPERATING INSTRUCTION

Attach the otoscope head to the handle by bayonet locking system, it is necessary to hold the battery handle
and head in each hand and match the bayonet grooves on both the head and handle, push the head down
and turn the head clock wise as in Fig.1.

1. Check that the connection between the head and handle is perfect and that the rheostat works properly.

2. Push the button (F) on the handle and twist the black knob (G) towards the left hand side.
The unit is now in operating position. The intensity of the light can be adjusted by turning the knob clock

wise or counter clock wise.

3. Switch off 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.

Attaching a tip

The Otoscope may only be inserted into the auditory canal when a disposable (grey) or reusable (black) tip is
tted. Push the tip onto the instrument so that the internal projection engages in the slit (A) as in Fig.1. Twist to
the right to lock. Do not reuse the disposable speculum, because may cause patient-to-patient contamination.

6

Changing the lamp

With the Otoscope, rst unlock the head from the handle and pull the lamp (D) downwards as in Fig.2. Push
in the new lamp.

Magnifying lens

The lens (B) has 3 x magnications and can be swiveled aside for instrumentation.

Insufations port

An insufations bulb can be tted to the port (C). A separately Insufations bulb is used for pneumatic testing
of tympanic mobility.

General illumination

The Otoscope can be used with or without a tip for general illumination of e.g. the oral cavity or skin. Avoid
contact with sensitive or damaged skin.

CLEANING AND STERILIZATION
Otoscope head

Clean the outside with a soft cloth, inside with a cotton wool bud, if necessary soaked in disinfectant or water.

Do not use rough cloth for cleaning the lens to avoid scratches.

Reusable Ear tips

These can be cleaned, disinfected or sterilized by any conventional method. Autoclaving is allowed. (121°C)

7

ENGLISH

OPERATING THE HANDLE

Push button (A) in Fig.3 inward and rotate the knob clock wise which will turn the power on and the lamp will
light up. This position is indicated by a RED indicator comes into view.
To switch off the instrument rotate the knob counter clock wise till an audible sound is heard.

Changing the batteries

Unscrew the end-cap (E) and shake out the old batteries.
Insert new batteries as Shown in Fig.3. Take care that the poles point in the right direction.

CLEANING

The handle can be cleaned with a cloth soaked with disinfectant however it cannot be dipped into liquids.

Caution:

- 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 or oxidation is present.
In case of necessity replace them with new ones.

- Carefully handle the batteries as the liquids 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/Off 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.

Caution: read instructions (warnings) carefully Follow instructions for use

Keep in a cool, dry place Keep away from sunlight

Manufacturer Date of manufacture

Product code Lot number

Medical Device compliant with Regulation
(EU) 2017/745

WEEE disposal Medical Device

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.

Type B applied part