mibeTec bite away Instrucciones De Uso página 2

Advertências
bite away não pode ser usado em
®
−
Olhos e pálpebras
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Membranas mucosas
−
Feridas abertas, pele danificada
−
Pele escaldada ou queimada
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Pele com frieiras
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Neuropatia de pequenas fibras, alodinia, hiperalgesia
−
Tumores e alterações malignas da pele
−
Pessoas com sensibilidade reduzida devido a queixas físicas ou mé­
dicas
−
Zonas da pele sensíveis ou com má circulação.
Caso ocorram fortes reações de hipersensibilidade após a picada ou mor­
dida de inseto (reação anafilática), bite away
de emergência. Nesse caso, após a ocorrência dos primeiros sinais (p. ex.,
aumento da comichão na pele, vermelhidão, inchaço e borbulha;. tontu­
ras, náuseas, falta de ar, queda ou subida de tensão), consulte imediata­
mente um médico.
Nos seguintes casos, consulte um médico:
−
Queixas persistentes durante a aplicação de bite away
−
Agravamento das queixas durante a aplicação de bite away
seja detetado o motivo, o produto deve deixar de ser aplicado.
−
Mordidas de carraça, uma vez que esta picada pode transmitir agentes
patogénicos, como a doença de Lyme ou encefalite da carraça.
Além disso, o dispositivo não pode ser usado:
−
Imediatamente após aplicação de pomadas, cremes, loções, etc. no
local afetado
−
Em pele húmida.
Dependendo da sensibilidade, a temperatura de tratamento pode ser sen­
tida como desagradável.
Em pessoas sensíveis, pode ocorrer vermelhidão temporária da pele após
a aplicação. Em casos raros, em utilizadores com tipo de pele sensível,
pode ocorrer irritação da pele.
O dispositivo indica que tem uma anomalia se o LED piscar 5 vezes e
soar um sinal acústico 5 vezes. Isso pode ocorrer, por exemplo, por má
utilização, acionando e usando o dispositivo no ar e não na pele. Caso
essa mensagem de erro se repita apesar da aplicação correta, entre em
contacto com o fabricante ou o distribuidor.
Não utilize o aparelho com danos nem com mau funcionamento visível.
Não use baterias (pilhas recarregáveis).
Aviso sobre armazenamento
Conserve o dispositivo protegido da luz solar direta e em lugar seco.
Não utilize a pilha para além da data de validade nela indicada. Para evitar
danificar o bite away com fugas de ácido das pilhas, estas devem ser reti­
®
radas durante períodos prolongados de não utilização.
Fabricante:
GmbH
Münchener Straße 15
06796 Brehna
Alemanha
Tel.: +49 (0) 800/162 35 09
Fax: +49 (0) 34954/247­27179
Contato em português:
e­mail: contact­portugal.mibetec@dermapharm.com
www.bite­away.com
Em caso de dúvidas sobre o produto e o funcionamento, contacte o fabri­
cante ou o distribuidor.
Data da informação: Novembro de 2018
Observe as informações de utilização Conserve o dispositivo protegido
da luz solar direta e da humidade,
em lugar seco.
Lote: ver dispositivo Não eliminar junto com o lixo
doméstico.
Dados técnicos:
AA LR6 1,5V
Tipo de pilha / tensão da pilha Peça de aplicação do tipo BF,
conforme EN 60601­1
GI03266-01
GI03266-01_bite_away_ES-PT.indd 2
Instructions for use
Simple | quick | well-tolerated
A medical device for symptomatic treatment of insect stings and bites
Intended use
bite away is a patented medical device for the symptomatic treatment of
®
itching, pain and swelling caused by insect stings and bites, for example
não substitui o tratamento
®
by mosquitoes, wasps, bees, hornets or horseflies. If the device is applied
immediately after the sting/bite, the symptoms can normally be preven­
ted altogether. Even if the device is used slightly later, the symptoms can
fade away sooner.
How it works
.
®
bite away works solely by concentrated heat and is thus completely free
®
. Até que
® from chemicals.
Hence, bite away
and children.
The application of concentrated heat (local hyperthermia) is a physical
mode of action based on a brief, concentrated application of heat to a
small, limited area of skin. This localised pulse of heat may be sufficient
to trigger a response from the body that reduces itching and pain and
subsequently causes any swelling to go down.
If the device is applied immediately after the sting/bite, the symptoms can
normally be prevented altogether, so the affected site on the body should
be treated as quickly as possible. Even if the device is used slightly later,
the symptoms can fade away sooner.
Administration
bite away is very simple to use:
®
−
Place the ceramic contact plate of the device onto the sting or bite (re­
move the stinger first if necessary) and gently press it against the skin.
−
Then select one of the two treatment times by pressing the correspon­
ding button:
3 seconds (left­hand button) for the initial treatment and for peo­
ple with sensitive skin
5 seconds (right­hand button) for a regular application.
The ceramic contact plate will heat up to a temperature of around
51°C. Once this temperature is reached a LED will light up. The LED
will go off once the device automatically shuts down after the end of
the chosen treatment time. At the start of the heating­up phase and at
the end of the treatment, you will hear an additional acoustic signal.
If necessary, multiple treatment of the same insect sting or bite is possi­
ble. Please leave a treatment interval of at least 2 minutes between each
application. Do not exceed a maximum number of 5 applications per hour
on the same insect sting or bite.
Directions for use
bite away is indicated only for self­administration by adults and children
®
aged 12 years and older. In children under 12 years of age, it should be
used only with the assistance of an adult.
Cleaning information:
The ceramic contact plate of the device can be easily cleaned with a stan­
dard alcohol disinfectant wipe; all other external surfaces, for example,
with a clean cloth.
Battery replacement:
PRESS
1
INSERT BATTERIES (AA LR6 1.5V)
3
To change the batteries, the battery cap must be removed and refitted
after inserting the batteries (see illustration).
When the battery needs changing, the LED will flash 3 times and the
acoustic signal will sound 3 times.
Do not use rechargeable batteries.
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is also suitable for pregnant women, allergy sufferers
®
5s
OPEN
2
Warnings
bite away must not be used in or on
®
−
eyes or eyelids
−
mucous membranes
−
open wounds, damaged skin
−
scalded or burnt skin
−
frostbite
−
small­fibre neuropathy, allodynia, hyperalgesia
−
tumours and malignant changes of the skin
−
people with reduced sensitivity due to physical or medical complaints
−
sensitive skin areas or skin areas with poor blood supply.
In the event of severe hypersensitivity reactions after an insect bite or
sting (anaphylactic reaction), bite away ® is not a replacement for emer­
gency treatment. You should immediately call a doctor at the first signs of
any such reaction (e.g. increased itching, reddening, swelling or formation
of a welt; dizziness, nausea, difficulties breathing, hypotension or hyper­
tension).
Medical advice should be sought in the following cases:
−
persistent symptoms while using bite away .
®
−
worsening symptoms while using bite away . Until these have been
®
clarified, you should stop using the device.
−
tick bites, as bites of these arachnids can cause the transmission of
pathogens such as Lyme disease or tick­borne encephalitis (TBE).
Furthermore, the device must not be used:
−
immediately after application of ointments, creams, lotions etc. on the
affected site
−
on moist skin.
Depending on sensitivity, the treatment temperature may cause some
discomfort.
In sensitive individuals, a temporary reddening of the skin may occur after
use. In rare cases, users with sensitive skin types may experience skin
irritation.
The device indicates failure by flashing the LED 5 times and sounding the
acoustic signal 5 times. This may occur if used incorrectly, e.g. if the user
triggers and operates the device in the air instead of on the skin. If this
error message occurs repeatedly despite proper use, please contact the
manufacturer or distributor.
Do not use the device if damaged or in case of obvious malfunction. Do
not use damaged batteries.
Storage instructions
Store the device protected from direct sunlight and in a dry place.
Do not use the batteries beyond the expiry date which is stated on the
batteries. In order to avoid damage to bite away due to leaking battery
®
acid, the batteries should be taken out during prolonged periods of non­
use (inactivity).
Manufacturer: Distributor in UK:
GmbH Mibe Pharma UK Ltd
Münchener Straße 15 Marco Polo House
06796 Brehna 3­5 Lansdowne Road,
Germany Croydon,
Tel.: +49 (0) 800/162 35 09 United Kingdom, CR0 2BX
Fax: +49 (0) 34954/247­27179 Tel.: +44 (0) 2038707504
E­mail: customerservice@mibe.de
www.bite­away.com
Please contact the manufacturer or distributor if you have any questions
about the device or how it works.
Date of revision of the text: November 2018
Please read the instructions Protect the device from direct
for use sunlight and store in a dry place/
protect from moisture.
See device for batch number Do not dispose with household
waste
Technical data:
AA LR6 1,5V
Battery type/­voltage Applied part type BF
according to EN 60601­1
0123
05.07.2019 13:51:40