LifeWave BST User manual

© All Right Reserved, LifeWave Ltd. 2010 1
LifeWave BST
User Manual
For Hospital, Clinic and Home Care
www.life-wave.com

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Introdução
Indicações de Uso
Descrição Geral do Dispositivo
Contra-indicações
Efeitos Colaterais
Avisos
Precauções
Antes de Começar
Sessão de Tratamento
Fim da Sessão de Tratamento
Limpeza e Desinfecção
Armazenamento e Meio Ambiente
Manutenção e Peças de Reposição
Solução de Problemas
Especificações Técnicas
Definição dos Símbolos
Garantia
Copyright
Parâmetros EMC (Compatibilidade Eletro-Magnética)
Índice de Conteúdo
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LifeWave BST-Bioelectrical Signal Therapy™ (Terapia por Sinais
Bioelétricos), de propriedade da LiveWave, é um dispositivo para o
tratamento de úlceras crônicas. O dispositivo emite um sinal elétri-
co específico através do tecido cutâneo para estimular o processo
natural de cicatrização da ferida no corpo humano.
Este sinal foi identificado em pessoas durante o processo natu-
ral de cicatrização de úlceras crônicas, estando associado com
a ação dos nervos durante o processo de cicatrização. A trans-
missão deste sinal em úlceras crônicas cria um campo elétrico
semelhante ao do processo “normal” de cicatrização de feridas.
O sinal BST é aplicado à úlcera por um único canal Bioelétrico
através de um par de eletrodos de superfície (“eletrodos BST”) que
estão ligados à pele saudável ao redor da ferida. O uso de cada
par de eletrodos é feito de acordo com a indicação do fabricante
situada na embalagem dos eletrodos. LifeWave BST é um disposi-
tivo médico de fácil operação.
LifeWave BST é indicado para o tratamento de úlceras crônicas,
ou seja, ferimentos com dificuldade para cicatrização.
LifeWave BST está composto pelos seguintes componentes:
1. O dispositivo BST (gerador Bioelétrico): um sistema com-
putadorizado baseado em software especialmente projetado que
gera o sinal de tratamento.
2. Eletrodos LifeWave BST: Um par de eletrodos descartáveis
que emite a corrente Bioelétrica para a pele ao redor da ferida. A
duração do uso dos eletrodos está indicada na embalagem dos
mesmos.
Introdução
Indicações de Uso
Descrição Geral do Dispositivo
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você tem menos de 18 anos.
Você tem um marca-passo ativo no peito ou região epigástrica, ou
seja, abdômen médio ou superior.
Se você estiver grávida ou amamentando.
Você está sendo tratado com produtos contendo íons de metal para a feri-
da, como curativos com prata, alumínio ou que conduzam eletricidade.
Há presença de tecido canceroso a menos de 10 cm de sua ferida.
Você foi diagnosticado com epilepsia ou sofre de outra condição neu-
ro-excitativa (relacionada com o sistema nervoso).
Não use LifeWave BST se:
Além do efeito terapêutico do LifeWave BST, o uso deste sistema
pode apresentar alguns efeitos colaterais durante o tratamento.
Reações alérgicas, prurido leve, bolhas na pele, formigamento,
inchaço, vermelhidão constante ou desconforto em áreas onde os
eletrodos foram colocados, requerem atenção médica.
Se qualquer uma destas reações ou efeitos colaterais ocorrerem,
favor entrar em contato com seu médico imediatamente.
Se há presença de tecido de granulação excessivo (hipergranu-
lação), pare o tratamento imediatamente.
Não use LifeWave BST se houver a presença de material metálico
(placa(s), parafuso(s), fio(s) metálico(s)) em proximidade direta de
sua ferida.
Contra-indicações
Efeitos Colaterais
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Evite telefones celulares ou qualquer outro aparelho de comuni-
cação quando operar o LifeWave BST.
Não opere o LifeWave BST perto de equipamento de ondas curtas
ou microondas (mesmo que seja de terapia).
Não conecte o LifeWave BST simultaneamente com outro equipa-
mento de alta freqüência em você mesmo.
Não abra o dispositivo BST. Há perigo de choque elétrico.
Não use o LifeWave BST se há sinais visíveis de danos ao cabo de
conexão, eletrodos ou o dispositivo BST.
Não exponha o LifeWave BST à água.
Você não pode usar cabos ou eletrodos de outro fabricante.
Não aplique os eletrodos LifeWave BST diretamente no ferimento
ou em seus bordos, veja parágrafo “Conexão dos Eletrodos”.
Não ligue os eletrodos LifeWave BST um ao outro.
Não dobre os eletrodos LifeWave BST.
Posicione todos os cabos com cuidado para que não se en-
rosquem.
Assegure-se de não estar deitado ou sentado sobre algum compo-
nente LifeWave BST durante o tratamento.
Opere o LifeWave BST de acordo com as condições especificadas
na seção Parâmetros EMC deste manual.
Não esterilize nenhuma parte dos eletrodos LifeWave BST, cabo
conector LifeWave BST ou dispositivo BST: poderá haver dano ou
destruição.
Faça todas suas chamadas de serviço ao seu médico ou distribuidor.
Avisos
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Os eletrodos LifeWave BST são descartáveis e são para um único
ferimento. Cada ferimento requer um novo par de eletrodos.
Inspecione o ferimento com freqüência seguindo o procedimento
recomendado pelo seu médico. Entre em contato com seu médico
se houver deterioração ou se você suspeita de piora das condições
da ferida. Se o ferimento parece piorar ou mudar de cor, inclusive
preto, amarelo ou verde, pare de usar o LifeWave BST e consulte
seu médico.
Se o ferimento está com infecção trate-o de acordo com as
instruções de seu médico. Se você tem crescimento exces-
sivo de tecido de cicatrização (hipergranulação), ou se você
tem tendência de criar tecido excessivo de cicatrização na
área do ferimento, consulte seu médico antes de usar o dis-
positivo.
Se você sofre de uma doença cardíaca descompensada, de dis-
túrbios da coagulação (sangramento não controlado), ou se você
tem um implante metálico, consulte seu médico antes de usar o
dispositivo.
Em caso de câncer qualquer sinal de deterioração que ocorrer
mais rapidamente do que o esperado deve ser acompanhado
pelo seu médico.
Assegure-se que o dispositivo BST e os cabos conectores pas-
saram por um processo de limpeza e desinfecção conforme
descrito na seção de limpeza e desinfecção antes de transferí-
lo de um ferimento para outro, se aplicável.
O LifeWave BST deve ser operado de acordo com os parâme-
tros EMC listados nas Tabelas 1, 2, 4 e 6 no final deste ma-
nual.
Precauções
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Favor ler o manual do usuário antes de usar o LifeWave BST.
Fig. 1. Dispositivo BST Fig. 2. Cabo de força
Fig. 3. Cabo conector Fig. 4. Eletrodos descartáveis
LifeWave BST e seus condutores
Fig. 5. Comutador de força Fig. 6. Apresentação do botão de
contraste
Fig. 8. Conexão dos condutores dos
eletrodos ao cabo conector
Fig. 7. Conexão do cabo conector ao
dispositivo BST
Antes de Começar
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Cada embalagem LifeWave BST contém o seguinte:
1. Dispositivo BST (Fig. 1)
2. Cabo de força (Fig. 2)
3. Cabo conector (Fig. 3)
4. Eletrodos descartáveis LifeWave BST e seus condutores (Fig. 4)
Favor verificar se todos os componentes estão disponíveis antes de iniciar o
tratamento.
Conteúdo
Conexão da Força
Conexão dos Eletrodos
1. Coloque o dispositivo BST (Fig. 1) sobre uma superfície plana e
limpa e conecte o cabo de força (Fig. 2) ao dispositivo BST.
2. Coloque o cabo de força (Fig. 2) na tomada e ligue o dispositivo BST
usando o comutador de força (Fig. 5).
3. A logomarca do LifeWave BST aparece na tela, indicando que
o sistema está pronto.
Se o temporizador (timer) de um tratamento prévio aparece, desligue o dis-
positivo com o comutador de força (Fig. 5) e ligue novamente para fazer a
rechecagem (reset).
Nota:
Para ajustar o contraste da apresentação, gire o botão (Fig. 6) localizado no lado
direito do dispositivo BST.
Limpe e seque a pele em redor da ferida de acordo com as instruções de seu
médico. A limpeza é necessária para assegurar que a pele está livre de qualquer
sujidade e que está suficientemente seca para permitir a anexação dos eletrodos.
2. Abra o pacote de eletrodos.
3. Separe e remova o invólucro externo dos eletrodos para expor a su-
perfície adesiva dos eletrodos e tente não tocar nesta superfície para
não perder o poder adesivo.
4. Coloque os eletrodos firmemente em lados opostos do ferimento.
Cada lado côncavo dos eletrodos devem estar entre 1,5 e 2 cm da
borda do ferimento.
5. Conecte o condutor do eletrodo ao cabo conector (Fig. 8).
1. Conecte o cabo conector (Fig. 3) ao dispositivo BST (Fig. 7).
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A duração de uma sessão programada de tratamento é de 30 minutos,
duas ou três sessões por dia por lesão. Seu médico poderá instruir
você a ter sessões adicionais por cada ferimento. Cada sessão não
deve ultrapassar 30 minutos, com um mínimo de 5 horas entre as ses-
sões de um mesmo ferimento.
Nota Importante: Para chegar aos melhores resultados é importante
seguir as orientações e o regime de tratamento conforme instruído pelo
seu médico.
Assegure-se que os eletrodos estão firmemente aderidos à pele em
redor do ferimento durante todo o tratamento.
1. Pressione o botão verde “START” (INICIAR) (botão da esquerda)
2. Verifique que as duas marcas ( ) aparecem indicando que o Life-
Wave BST está perfeitamente conectado e pronto para uso.
3. Pressione o botão verde “START” (INICIAR) (botão da esquerda) no-
vamente. Um temporizador (timer) de 30 minutos aparecerá e a conta-
gem será iniciada.
4. Após 30 minutos o sinal bioelétrico é suspenso de forma automática,
e um sinal sonoro (bip) será ouvido, indicando o fim da sessão.
Botões de operação do BST
ÁUDIOINICIAR PARAR
Inicie o Tratamento
indica que o LifeWave BST está pronto para o uso
Sessão de Tratamento
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010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
1. Assim que a sessão de tratamento acabar desligue o comutador
de força do dispositivo BST.
2. Desconecte os condutores dos eletrodos do cabo conector. Con-
serve os eletrodos na sua pele.
3. Se esta for a última vez que você está usando este par de eletro-
dos (a duração dos eletrodos está marcada nas etiquetas destes)
remova-os pelas suas bordas e retire com cuidado para longe da
pele na direção da ferida. Não puxe pelo condutor do eletrodo para
removê-lo.
Se o botão azul AUDIO (botão do meio) é pressionado será ouvido
um bip a cada 10 segundos durante o tempo de tratamento, indi-
cando que o LifeWave está operando de forma adequada.
Se o dispositivo identifica um problema, por exemplo, a desco-
nexão dos eletrodos, um bip será ouvido cada 2 segundos. Neste
caso, verifique se os cabos estão conectados adequadamente e
que os eletrodos estão devidamente aderidos à pele.
Para desligar o sinal de alarme no final da sessão pressione o
botão azul AUDIO (botão do meio). Quando o som está desliga-
do você receberá apenas notificação visual quando o tratamento
acabar.
Para pausar uma sessão em qualquer hora pressione o botão ver-
melho “STOP” (PARAR) (botão da direita) uma vez. Pressione o
botão verde “START” (INICIAR) (botão da esquerda) para continu-
ar a sessão do ponto em que você fez a pausa.
Para encerrar uma sessão em qualquer hora, pressione o botão
vermelho “STOP” (PARAR) (botão da direita) duas vezes.
Sessão de Tratamento – Notas
Fim da Sessão de Tratamento
© Todos os Direitos Reservados, LifeWave Ltd. 2010
74

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
Limpe e desinfete o dispositivo BST e os cabos antes de iniciar o
uso e no final do período de tratamento.
Se você tem mais de um ferimento que deve ser tratado com o
BST, limpe e desinfete o dispositivo entre as sessões para uso em
diferentes ferimentos. Use o seguinte procedimento para limpar e
desinfetar o dispositivo BST e os cabos:
1. Desligue o dispositivo BST usando o comutador de força (Fig. 5).
2. Desconecte o cabo de força (Fig. 2) da tomada e do dispositivo BST.
3. Desconecte o condutor dos eletrodos do cabo conector (Fig. 7).
Se esta for a última sessão de tratamento com estes eletrodos (a
duração dos eletrodos está marcada nas etiquetas destes), jogue-
os fora, bem como os seus condutores.
4. Use um pano úmido, macio e sem fibras, umedecido com água
limpa para remover sujeira e fragmentos da superfície do disposi-
tivo BST e dos cabos. Não use solventes plásticos (orgânicos) e
nem materiais abrasivos. Cuide para não deixar água entrar no dis-
positivo BST.
5. Seque com outro pano macio.
6. Limpe todas as superfícies do dispositivo BST e dos cabos com
um tecido sem fibras umedecido com álcool etílico à 70%, ou com
material comercial desinfetante disponível.
7. Seque com outro tecido seco sem fibras.
Limpeza e Desinfecção
תירבעةيبرعلا Русский Español Italiano FrançaisPortuguês Deutsch English
© Todos os Direitos Reservados, LifeWave Ltd. 2010 75

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
Se seu dispositivo BST requer reparos ou peças de reposição,
favor entrar em contato com seu médico ou distribuidor.
Armazene o LifeWave BST em local seco em temperatura ambi-
ente.
Condições Ambientais Permitidas
Alcance de temperatura de
operação
5°C a 40°C (41°F a 104°F)
Alcance de temperatura de
armazenamento
-10°C a 50°C (50°F a 122°F)
Umidade de operação 5% a máx. 95% de umidade relativa (não
condensada)
Umidade de armazenamento 30% máx. 85% UR (não condensada)
Manutenção e Peças de Reposição
Armazenamento e Meio Ambiente
© Todos os Direitos Reservados, LifeWave Ltd. 2010
76

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
A tabela seguinte apresenta possíveis falhas e as medidas que de-
vem ser tomadas em resposta.
Você notou Causa possível Medidas a tomar
A tela não mostra
nada depois de ligar o
LifeWave BST
1. Não há força para o
LifeWave BST.
2. O botão de contraste
está na posição MIN ou
MAX.
1. Verifique as conexões
do cabo de força (toma-
da, dispositivo BST) e/
ou certifique-se que o
comutador de força está
em ligado.
2. Gire o botão de con-
traste da apresentação
para mudar o contraste
da apresentação
O temporizador (timer)
parou no meio de uma
sessão
(o ícone aparece)
O botão vermelho
“STOP” (PARAR) (botão
da direita) foi pressiona-
do por engano
Pressione o botão verde
“START” (INICIAR) (botão
da esquerda) novamente
e note que a contagem
de tempo continua de
onde parou.
O timer parou no meio
de uma sessão
(o ícone aparece)
O circuito elétrico entre
o dispositivo BST e os
eletrodos foi cortado
1. Certifique-se que os
eletrodos estão firme-
mente aderidos à sua
pele. Se o problema
persistir
...
2. Certifique-se que
o cabo conector está
firmemente conectado
com os condutores
dos eletrodos e com o
dispositivo BST. Se o
problemas persistir
...
3.Contate seu médico ou
distribuidor.
Solução de Problemas
תירבעةيبرعلا Русский Español Italiano FrançaisPortuguês Deutsch English
© Todos os Direitos Reservados, LifeWave Ltd. 2010 77

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
LifeWave BST
Eletrodos
Características Físicas
Altura 130mm (5.11")
Comprimento 256mm (10.07")
Largura 220mm (8.66")
Peso 1850 g
Classificação Segurança
Classe II Tipo BF EN60601-1 IEC
60601-1:90+A1(93)+A2(95)
CSA C22.2 No. 60 1.1
Características Físicas
L x C em cm (pol) 7.5cm x 4.5cm (2.96” x 1.72”)
Comprimento do cabo em cm (pol) 66cm (26”)
Característica Elétricas
Máxima corrente de saída 6.5 mA r.m.s. (on 500 Ohm)
O total de saída proporciona DC zero
líquida
Fonte de força 120V, 60Hz, 0.2A ou 230V,50Hz, 0.1A
dependendo do modelo
Forma da onda de saída Forma de onda bifásica simétrica com-
posta de:
1) Um pulso retangular – taxa de 4pps,
largura de pulso 4ms, com espaça-
mento de:
2) Um sinal estocástico (aleatório),
espectro de saída de 0 a 3000 Hz. A
80% da força de 0 a 1300 Hz.
Especificações Técnicas
© Todos os Direitos Reservados, LifeWave Ltd. 2010
78

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
Símbolo Descrição
Equipamento Classe II
Cuidado, consulte documentação acompanhante
Equipamento tipo BF aplicado (de acordo com EN/IEC
60601-1)
Marcas CE de acordo com a diretiva de Dispositivos
Médicos 93/42/EEC
Marcas CSA de acordo com a Associação Canadense de
Padrões – CSA/C22.2 no. 601
Data de fabricação
Fabricante
Número de série
Representante autorizado no Brasil (em Portugal)
Símbolo de conformidade de Disposição de Equipamen-
to Elétrico e Eletrônico
Não use novemente
Número de catálogo
Limites de temperatura
Número de lote
Use até data
Conserve seco
Definição dos Símbolos
תירבעةيبرعلا Русский Español Italiano FrançaisPortuguês Deutsch English
© Todos os Direitos Reservados, LifeWave Ltd. 2010 79

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
LifeWave Ltd. (LifeWave), o fabricante do LifeWave BST, garante
o LifeWave BST-Bioelectrical Signal Therapy™ (Terapia de Sinais
Bioelétricos), (“LifeWave BST” ou “o dispositivo”) através de sua
distribuição local contra defeitos de material e trabalho sob con-
dições normais de uso por um período de um ano a contar da data
da compra/início do uso. Em caso de reclamação, favor entrar em
contato com seu distribuidor local, cujos detalhes estão na página
oposta.
Copyright © 2010 da LifeWave Ltd. A LifeWave Ltd. se reserva o direito
de fazer mudanças em seus produtos ou especificações para melho-
rar o desempenho, confiabilidade e/ou manufatura. As informações
fornecidas pela LifeWave Ltd. são tidas como precisas e confiáveis.
Entretanto, a LifeWave Ltd. não assume nenhuma responsabilidade
pelo seu uso. Todos os direitos reservados. Nenhuma parte desta
publicação pode ser reproduzida, transmitida, transcrita, armaze-
nada em sistema de recuperação ou traduzida para qualquer língua
ou linguagem de computador, de qualquer forma ou por qualquer
meios, eletrônicos, mecânicos ou de outra forma, sem o prévio con-
sentimento por escrito da LifeWave Ltd.
Garantia
Copyright
© Todos os Direitos Reservados, LifeWave Ltd. 2010
80

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
תירבעةيبرعلا Русский Español Italiano FrançaisPortuguês Deutsch English
© Todos os Direitos Reservados, LifeWave Ltd. 2010 81

Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions – LifeWave BST
The LifeWave BST is intended for use in the electromagnetic environment specied below; the
customer or the user of the LifeWave BST should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The LifeWave BST uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B
The LifeWave BST is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuations
icker emissions
IEC 61000-3-3
Complies
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity – LifeWave BST
The LifeWave BST is intended for use in the electromagnetic environment specied below; the
customer or the user of the LifeWave BST should assure that it is used in such an environment.
Immunity
test
IEC 60601
Test level
Compliance
level Electromagnetic environment - guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30%.
Guidance and manufacturer’s declaration for electromagnetic
compatibility (EMC) for the LifeWave BST according to
EN 60601-1-2:2007
© All Right Reserved, LifeWave Ltd. 2010
EMC Parameters
146

010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
010101010110001110011010101011100010101011100001010110101010110101
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions – LifeWave BST
The LifeWave BST is intended for use in the electromagnetic environment specied below; the
customer or the user of the LifeWave BST should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The LifeWave BST uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B
The LifeWave BST is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuations
icker emissions
IEC 61000-3-3
Complies
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity – LifeWave BST
The LifeWave BST is intended for use in the electromagnetic environment specied below; the
customer or the user of the LifeWave BST should assure that it is used in such an environment.
Immunity
test
IEC 60601
Test level
Compliance
level Electromagnetic environment - guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30%.
Table 2 (Cont.)
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
Not Applicable
Main power quality should
be that of a typical public
low-voltage power supply
network that supplies
buildings used for domestic
purposes, commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common
mode
Main power quality should
be that of a typical public
low-voltage power supply
network that supplies
buildings used for domestic
purposes, commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
.
<5 %UT
(>95 %dip in UT)
for 0,5 cycle
40 %UT
(60 %dip in UT)
for 5 cycles
<5 %UT
70 %UT
(30 %dip in UT)
for 25 cycles
<5 %UT
<5 %UT
(>95 %dip in UT)
for 5 s
<5 %UT
(>95 %dip in UT)
for 0,5 cycle
40 %UT
(60 %dip in UT)
for 5 cycles
<5 %UT
70 %UT
(30 %dip in UT)
for 25 cycles
<5 %UT
<5 %UT
(>95 %dip in UT)
for 5 s
Main power quality should
be that of a typical public
low-voltage power supply
network that supplies
buildings used for domestic
purposes, commercial or
hospital environment.
If the user of the LifeWave
BST requires continued
operation during power
mains interruptions, it
is recommended that
LifeWave BST be powered
from an uninterruptible
power supply or battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
elds should be at levels
characteristic of a typical
public low-voltage power
supply network that supplies
buildings used for domestic
purposes, commercial or
hospital environment.
NOTE: UT is the a.c. main voltage prior to application of the test level.
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© All Right Reserved, LifeWave Ltd. 2010 147

Table 4
Guidance and manufacturer’s declaration – electromagnetic immunity – LifeWave BST
The LifeWave BST is intended for use in the electromagnetic environment specied below; the
customer or the user of the LifeWave BST should assure that it is used in such an environment.
Immunity
test
IEC 60601
Test level
Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 k Hz
to 80 MHz
3 V/m
80 MHz to
2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the LifeWave BST, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.17√P
d = 1.17√P 80 M Hz t o 800 MHz
d= 2.34√P 800 MHz t o 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency range d
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reection from structures, objects and people.
a - Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radios, AM and FM radio broadcasts and TV
broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be considered.
If the measured eld strength in the location in which the LifeWave BST is used exceeds the
applicable RF compliance level above, the LifeWave BST should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the LifeWave BST.
b - Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
© All Right Reserved, LifeWave Ltd. 2010
148
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