Gima ADJUSTABLE MIRROR HANDLE User guide

PROFESSIONAL MEDICAL PRODUCTS

SPECCHI LARINGE
LARYNGEAL MIRROR
MIROIRS LARYNGIENS
ESPEJO LARINGE
ESPELHOS DE LARINGE

Manuale d’uso - User manual - Manuel de l’utilisateur
Guía de uso - Guia para utilização

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.

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.

31600 - 31601 - 31602 - 31603 - 31604 - 31605
31606 - 31607 - 31608 - 31612 - 31615 - 31616

Gima S.p.A.

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

www.gimaitaly.com

M31600-M-Rev.1-04.20

Made in Pakistan

ENGLISH

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PRODUCTS

31600 Laryngeal mirror number 000 diam. 10mm
31601 Laryngeal mirror number 00 diam. 12mm
31602 Laryngeal mirror number 0 diam. 14mm
31603 Laryngeal mirror number 1 diam. 16mm
31604 Laryngeal mirror number 2 diam. 18mm
31605 Laryngeal mirror number 3 diam. 20mm
31606 Laryngeal mirror number 4 diam. 22mm
31607 Laryngeal mirror number 5 diam. 24mm
31608 Laryngeal mirror number 6 diam. 26mm
31612 Set 9 laryngeal mirror
31615 Adjustable mirror handle
31616 Adjustable mirror handle

ATTENTION

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 the component against the
standard conguration. Check that it is present and in perfect condition.

INTENDED USE

The device is used to visualize a patient’s internal area (Throat, Larynx).

PRODUCT OVERVIEW

Laryngeal mirrors are detachable hand held medical equipment convenient to have a better exam of throat and larynx of
human body, which are otherwise not visible by using the conventional methods. These devices, have been easy to use.
This device is crafted from corrosion-proof stainless steel.

FEATURES

• The laryngeal mirror is available in all standard sizes.

• It’s an integral part of diagnostic instrument.

• The device is crafted from corrosion proof stainless steel.

OPERATING PROCEDURE

Laryngeal mirror is commonly used for examining the larynx and other areas of the throat. It may be used to visualize the
throat for the application of anesthesia or removal of tissue. It is available with various diameter.

1. Ask the patient to relax and to stick out his or her tongue. Cover the tongue in gauze and pull it with the thumb and middle
nger of your non-dominant hand. Your index nger should be free to lift up the upper lip if necessary.

2. With the patient breathing in and out, direct the mirror into the mouth and toward the back of the throat, making sure the
glass side is downward. When at the back of the throat, press the mirror upward, against the uvula and soft palate. Avoid
the gag reex by not touching the posterior pharyngeal wall or tongue base. Slightly alter the position the mirror and
try various angles to visualize the desired structures. Ensure the patient’s head, chin, and body are still in the correct

position.

3. Make sure the patient is breathing in and out. Take note of the vocal cords while they are at rest. Then ask the patient to
make a loud sound and watch the vocal cord activity. If the mirror begins to fog up, reheat it and repeat from step 1.

CLEANING

Always clean it with proper care. The Product can be cleaned by using the following method:

1. Slightly moisten a cotton swab or cloth with isopropyl or ethyl alcohol and gently wipe the surface of the product.

2. Wipe from side to side rather than in a circular motion.

3. It should be rinsed in boiling distilled water, gently scrub to remove any residue.

4. Cold disinfectant can be used with the same concentration used to sterilize surgical instruments.

Note:

If chemical cleaners are used, see manufacturer’s instructions regarding use.

CAUTION

• To avoid any unwanted event, follow the instructions/precautions as written below:

• Read the label before losing packing.

• Handle it with care and keep the instrument away from the range of insects and rodents.

• Use proper media for sterilization.

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• Only qualied medical personnel should use it.

• Use cleaning, sterilizing and rinsing solution of near to pH 7.0.

• Use protective gloves and wash the hand with anti-bacterial soap before operating any medical operation.

• Use properly to increase the life of the instrument.

• Avoid placing the instrument for a longer time in water.

• Also not in contact with blood, in salty or humid atmosphere.

ENGLISH

WARNING

• Don’t use the equipment in case it is damaged, apply to your retailer.

• Do not exceed temperature of 134°C and pressure of 28 psi during autoclaving.

• Autoclaving the laryngeal mirror after removing from curved illuminated holder.

• Ultrasonic is not recommended.

• If the instrument has rusted, then don’t use it.

• Only use one type of material during sterilization process.

• Store in clean environment and preserve at normal temperature (5°C – 40°C) and constant humidity.

DISPOSAL

The product contains no hazardous materials. The product should be discarded accordance with the national or local
regulations.

RECOMMENDED OPERATING ENVIRONMENT

Operation

Temperature 10°C to 40°C
Humidity 30% to 75%
Air Pressure 700hPa to 1060hPa
Altitude 0 - 13123 feet (0 - 4000 meters)

Storage and Transport

Temperature -20°C to 60°C
Humidity 10% to 90% (Without Condensation)
Air Pressure 500hPa to 1060hPa

Keep in a cool,
dry place

Keep away from
sunlight

Consult instructions
for use

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

Manufacturer Product code

Medical Device compliant
with Regulation (EU) 2017/745

Caution: read instructions
(warnings) carefully

Lot number

Medical Device