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PROFESSIONAL MEDICAL PRODUCTS
DIAPASON LEGA 64-128 - RYDEL
TUNING FORK LEGA 64-128 - RYDEL
DIAPASON LEGA 64-128 - RYDEL
DIAPASÓN ALEACIÓN 64-128 - RYDEL
DIAPASÃO LIGA 64-128 - RYDEL
DIAPASON LEGA 64-128 - RYDEL
ΔΙΑΠΑΣΩΝ LEGA 64-128 - RYDEL
DIAPAZON DIN ALIAJ 64-128 - RYDEL
КАМЕРТОН LEGA 64-128 - RYDEL
ÖTVÖZET HANGVILLA 64-128 - RYDEL
È necessario segnalare qualsiasi incidente grave vericatosi 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.
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 rave
que haya ocurrido en relación con el producto sanitario que le hemos suministrado.
É necessário noticar o fabricante e as autoridades competentes do Estado-membro onde se está sediado sobre qualquer acidente grave vericado
em relação ao dispositivo médico fornecido por nós.
Jeder schwere Unfall im Zusammenhang mit dem von uns gelieferten medizinischen Gerät muss unbedingt dem Hersteller und der zuständigen
Behörde des Mitgliedsstaats, in dem das Gerät verwendet wird, gemeldet werden.
Είναι απαραίτητο να αναφέρετε οποιοδήποτε σοβαρό ατύχημα που προκύπτει σε σχέση με το ιατροτεχνολογικό μας προϊόν στον κατασκευαστή και
στην αρμόδια αρχή του κράτους μέλους στο οποίο βρίσκεστε
Orice accident grav produs, privitor la dispozitivul medical furnizat de către noi, trebuie semnalat producătorului și autorității competente din statul
membru pe teritoriul căruia își are sediul utilizatorul.
Всички сериозни инциденти, които са настъпили във връзка с доставеното от нас медицинско изделие, трябва да се сигнализират на
производителя и на компетентния орган на държавата членка, в която производителят е установен.
Az általunk szállított orvostechnikai eszközzel kapcsolatos bármilyen súlyos eseményt jelezni kell a gyártónak és az Ön székhelye szerinti tagállam
illetékes hatóságának
31247
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]
www.gimaitaly.com
Made in Germany
M31247-M-Rev.3-10.22
+70˚C
-40˚C
100%
%
10%
1060hPa
500hPa
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Thank you for choosing the Rydel-Seier C 128 neurological
8
6
4
2
8
6
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2
8
6
4
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8
6
4
2
Intensity of
Vibration
tuning fork with weight C 64. Our model is widely used as
a device to assess the degree of impairment of vibration
sensitivity in pallanaesthetic patients.
It can be used to diagnose nerve disorders dened as
polyneuropathies, which manifest themselves in the form of
impaired vibration sensitivity. The symptom is found in the
following diseases:
• Diabetes
• Toxic nerve damage
• Alcoholism
• Neuritis of bacterial origin
The product is intended for use only by appropriately trained
The GIMA tuning fork is very easy to use, and by taking just a few
precautions it can be used for many years.Do not use the device
if any signs of damage are found. Contact your dealer.
REQUIREMENTS
and specialised medical personnel.
The Rydel-Seier tuning fork generates two dierent
frequencies: note C = 64 Hz with the weights (as indicated
on the weights) and note c = 128 Hz without the weights
(as indicated on the tuning fork itself). The weights must be
attached at the level of the lowest notch on the arms of the
tuning fork. The mark “C 64” on the weights, the mark “c 128”
on the front of the tuning fork and the gradation must all be
facing the user when the weight is positioned. The knurled
screws are tightened to secure the weights and loosened to
remove them. Once the weights are in place, they must be
tightened rmly.
EASE OF USE:
There are two triangles on the weights, one white and one
black, each featuring a scale from 2 to 8.
Vibration intensity
When the tuning fork is struck against the ngertip of the
thumb (never strike it against objects that are too hard, such
as sheet metal, steel or stone), the arms begin to oscillate and
two triangles become visible on each weight. As soon as the
oscillation decreases, the two triangles gradually move closer
together again and their point of intersection moves upwards.
The scale shows the intensity of the vibrations. This can be
read either from the white triangle or from the black one,
depending on the amount of light available, or depending
on which scale is easier to read. To determine the degree
of insensitivity to vibrations, the tuning fork is touched and
its plastic base is placed against the olecranon or processus
mastoideus.
The patient must then indicate the point at which they stop
feeling vibrations. The vibration intensity at that precise
moment is read on the scale. The following values can be
considered normal:
• Patients below the age of 60: between 6 and 8
ENGLISH
• Patients above the age of 60: between 4 and 8
Vibration sensitivity in the foot region can be checked by
placing the tuning fork against the head of the bula, the
inner malleolus, the head of the metatarsus and the tip of
the hallux. The patient must once again indicate the point
at which they stop feeling vibrations. When a neuropathy is
present, there is generally a symmetrical decrease of vibration
sensitivity at the periphery compared to the proximal
values, especially at the front of the foot. The extent of the
neuropathy can be determined more accurately by placing the
tuning fork at successive points along the edge of the tibia.
Patients with decreased sensitivity due to sensory neuropathy
are especially prone to foot injuries because they usually do
not feel them until it is too late.
The tuning fork cannot be sterilised after use. It must 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:
Ambient temperature from -40°C to +70°C
Relative humidity from 10% to 100%, including condensation.
Atmospheric pressure from 500 to 1060 hPa.
Symbols
Date of manufacture Product code
Manufacturer Batch number
100%
%
10%
Medical device
compliant with
Regulation (EU)
2017/745
Read the instructions
for use
Store away from
sunlight
Humidity limit
Attention: Read and
follow the instructions
(warnings) carefully
Medical device
Store in a cool,
dry place
+70˚C
Temperature limit
-40˚C
1060kPa
Atmospheric
pressure limit
500kPa
GIMA WARRANTY TERMS
The standard GIMA B2B 12-month warranty applies.
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