Gima DIAPASON LUCAE CH 28 User guide

Page 1
PROFESSIONAL MEDICAL PRODUCTS
DIAPASON LEGA 128-CH LUCAE ALLOY TUNING FORK CH 128 LUCAE
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 office is located
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Germany
+70˚C
-40˚C
100%
%
10%
1060hPa
500hPa
M31246-M-Rev.0-12.22
Page 2
Thank you for choosing a GIMA tuning fork. The absolute accuracy of the sounds is guaranteed by the special alloy the device is made of.
PRESCRIPTIONS
The product is intended for use only by appropriately
trained and specialised medical personnel. The GIMA tuning fork is very easy to use, and by taking just a few precautions it can be
used for many years
FEATURES
The GIMA tuning fork is used for a variety of hearing tests (Rinnie test, Weber test, etc.), which test sound eld sensitivity transmitted to the ear both by air conduction (AC) and bone conduction (BC).
Conduc-
Description Parts of the apparatus
tion
AC An acoustic
stimulus is sent to the ear by air.
BC This is carried out
by placing the tuning fork stem in contact with the patient’s head;
the vibration caused by the instrument directly stimulates the inner ear.
in which hearing defects can be found
External auditory canal, middle or inner ear, auditory nerve or central auditory pathways.
Inner ear, auditory nerve, central auditory pathways.
ENGLISH
OPERATION
The frequency is changed by sliding weights on the prongs. These weights can be adjusted easily by hand. When selecting a tone, ensure that the weight spring is engaged in the tuning fork groove. This is the only way to obtain an accurate frequency. The two weights must always be set at the same height. It is therefore not possible to create intermediate tones by setting a weight on a tone that is dierent from the other. The letter printed directly below the weight indicates the tone produced. If possible, the tuning fork should be struck on the palm of the hand or on a piece of wood or plastic, never on an object that is too hard (such as sheet metal, steel or stone). The blow needs to be quick and strong; in other words, the turning fork must touch the object only briey.
The oscillation period of the tone will reach its maximum duration as a result of this short blow. During an examination (sensitivity test, etc.) the tuning fork is placed with the base of the black foot piece on the patient’s areas to be examined after striking them
Tuning forks cannot be sterilised after use. The tuning fork should be cleaned using a dry or slightly oily cloth.
TRANSPORT AND STORAGE
When packed for transport and storage, the device can be exposed to environmental conditions in the following ranges:
1. Ambient temperature from -40°C to +70°C
2. Relative humidity from 10% to 100%, including condensation.
3. Atmospheric pressure from 500 to 1060 hPa.
For a correct hearing test, active cooperation from the patient is required. In fact, the measurements made with the tuning fork are based on the patient’s own response during the test.
The tuning fork complies with the Lucae standard and produces 7 dierent frequencies, from c 128 to h 240. The accurate frequencies can be obtained from the tables below.
c d e f g a h
Frequency in Hz
128 144 160 170,66 192 213,33 240
Page 3
Symbols
ENGLISH
Date of manufacture Product code
Manufacturer Batch number
Attention: Read and follow the instructions (warnings) carefully
Medical device Read the instructions for use
Store in a cool, dry place Store away from sunlight
+70˚C
Temperature limit
-40˚C
1060kPa
Atmospheric pressure limit
500kPa
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Medical device compliant with Regulation (EU) 2017/745
100%
%
Humidity limit
10%
Loading...