PROFESSIONAL MEDICAL PRODUCTS
• Apparecchio per test pediatrico uditivo
• Paediatric hearing test device
• Appareil pour test pédiatrique auditif
• Aparato para test pediátrico auditivo
ENGLISH
Pediatric hearing test device
Instructions for use
This hearing screening device is intended for preliminary analysis of the audiometric
response in children aged 6 months and older.
Intended use:
The device is a small instrument helping parents to have general indications about the
child's response.
Indication: The pediatric hearing testing device is a small electronic instrument for
evaluating the response to sound stimulus in children aged 6 to 10 months (this does not
mean that it cannot be used also for older children). The two sounds used were calibrated
on frequencies and intensities to produce a high-pitched tone (pressing the T2 button)
and a low-pitched tone (pressing the T1 button).
If there is no response, please contact your doctor.
Contraindications: There are no known contraindications.
Improper use. The device's structure must not be modied. This could lead to erroneous
results, safety risks and damage to the device.
The device must only be used according to the instructions given.
Warranty. The warranty is void when:
• the indications in the instructions for use are not followed
• it is not used in compliance with the described uses
• changes are made or the device is opened
• there is damage of mechanical origin and damage due to the environment, liquids and
normal wear and tear
• there is inappropriate positioning or structure.
Keep within a temperature range of –5°C/50°C and use in a temperature range of
10°C/40°C. Keep away from heat sources.
Before using, carefully read the instructions for use.
Safety indications. Pay attention to the instructions.
• Only use batteries identical to those supplied (L1028 23A)
• Do not invert the polarity of the batteries when replacing.
• Do not use in the presence of ammable anaesthetic mixtures.
Delivery inspection.
device make sure there is no visible external damage.
Use. The test is easy to perform and is done following the BOEL test method (look
towards sound), by getting the child interested in an object that they can play with
and distracting their attention from the people around them. Then the above mentioned
sounds are made alternately in various areas (on the left and right, high and low, at a
distance of about 20 cm from the patient's ear) observing whether the child responds by
turning towards the sound. The compactness of the device and its shape make it easy
to use since they allow:
- it to be hidden in the palm of the hand so that child is only attracted by the sound of
the device,
- it to be held in either the right hand (pressing the button with the index and middle
ngers) or the left hand (using the thumb instead) without obstructing the small hole
in the centre of the device where the sound is emitted.
the child responds to this stimulus by turning his/her head and focusing, the test is
If
considered positive. If not, it is best to repeat the test after a few weeks since a simple
illness can aect the test.
Specications. Frequencies: 125Hz; 5kHz (±2%). Amplitude: 86dBA; 96dBA.
Cleaning. Do not use harsh detergents (solvents and the like), just use a damp cloth.
Do not immerse in water.
Check the packaging upon delivery and when unpacking the
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 specic recycling
point for electric and electronic equipment.
GIMA WARRANTY TERMS:
The Gima 12-month standard B2B warranty applies.
Via dei Cancellieri, 6/8 - 51100 Pistoia
100DM10 (33599)
REF
Revisione Gima M33599-Rev.2-06.21
Made in Italy
Loading...