laerdal BaXstrap Spineboard Mode d'emploi

Taper
Mode d'emploi
SPENCER ITALIA SRLSPENCER ITALIA SRL – Via Provinciale n° 12
43038 Sala Baganza (PR) – Italy
CS
Návod k použití a údržbě CELOTĚLOVÉ FIXAČNÍ POPRUHY
NL
Gebruikers- en onderhoudshandleiding INTEGRALE FIXATIEBANDEN
RO
Manual de utilizare și întreținere CENTURI PENTRU IMOBILIZARE TOTALĂ
FI
Käyttö- ja huolto-opas KOKOVARTALON KIINNITYSHIHNAT
EL
Εγχειρίδιο χρήσης και συντήρησης
ΙΜΑΝΤΕΣ ΠΛΗΡΟΥΣ ΑΚΙΝΗΤΟΠΟΙΗΣΗΣ
DA
Bruger- og vedligeholdelsesvejledning
INTEGREREDE FASTSPÆNDINGSBÆLTER
SV
Instruktioner för drift och underhåll HELTÄCKANDE SÄKERHETSBÄLTEN
LV
Lietošanas un apkopes rokasgrāmata INTEGRĒTAS DROŠĪBAS JOSTAS
PT
Manual de Uso e Manutenção CINTOS DE RETENÇÃO INTEGRAL
BG
Ръководство за употреба и поддръжка
КОЛАНИ ЗА ЦЯЛОСТНО ПРИДЪРЖАНЕ
NO
Bruks- og vedlikeholdsveiledning HELE SIKKERHETSBELTER
ES
Manual de uso y Mantenimiento
CINTURONES DE SUJECIÓN/RETENCIÓN INTEGRAL
FR
Manuel d’utilisation et d’entretien SANGLES ARAIGNÉES
SR
Uputstvo za upotrebu i održavanje INTEGRALNI SIGURNOSNI POJASEVI
JA
取扱説明書 一体型保持ベルト 取扱説明書 一体型保持ベルト
ZH
使用和维护手册 补充约束带 使用和维护手册 补充约束带
DE
Betriebs- und Wartungshandbuch INTEGRAL-HALTEGURTE
EN
Use and Maintenance Manual FULL BODY RESTRAINT BELT
IT
Manuale d’uso e Manutenzione CINTURE DI TRATTENUTA INTEGRALE
2
INDICE / CONTENTS / INHALTSVERZEICHNIS / SOMMAIRE
1. MODELLI 8
2. DESTINAZIONE D’USO 8
2.1 DESTINAZIONE D’USO E BENEFICI CLINICI 8
2.2 PAZIENTI DESTINATARI 8
2.3 CRITERI DI SELEZIONE PAZIENTI 8
2.4 CONTROINDICAZIONI ED EFFETTI COLLATERALI
INDESIDERATI 8
2.5 UTILIZZATORI E INSTALLATORI 8
2.5.1 FORMAZIONE UTILIZZATORI 8
2.5.2 FORMAZIONE INSTALLATORE 8
3. STANDARD DI RIFERIMENTO 8
4. INTRODUZIONE 8
4.1 UTILIZZO DEL MANUALE 8
4.2 ETICHETTATURA E CONTROLLO TRACCIABILITÀ
DEL DISPOSITIVO 8
4.3 SIMBOLI 9
4.4 GARANZIA E ASSISTENZA 9
5. AVVERTENZE/PERICOLI 9
6. AVVERTENZE SPECIFICHE 10
7. RISCHIO RESIDUO 10
8. DATI TECNICI E COMPONENTI 10
9. MESSA IN FUNZIONE 10
10. CARATTERISTICHE FUNZIONALI 11
11. MODALITA D’USO 11
11.1 APPLICAZIONE DELLE CINTURE 11
12. PULIZIA E MANUTENZIONE 11
12.1 PULIZIA 11
12.2 MANUTENZIONE ORDINARIA 11
12.3 REVISIONE PERIODICA 11
12.4 MANUTENZIONE STRAORDINARIA 12
12.5 TEMPO DI VITA 12
13. TABELLA GESTIONE GUASTI 12
14. ACCESSORI 12
15. RICAMBI 12
16. SMALTIMENTO 12
1. MODELS 13
2. INTENDED USE 13
2.1 INTENDED USE AND CLINICAL BENEFITS 13
2.2 TARGET PATIENTS 13
2.3 PATIENT SELECTION CRITERIA 13
2.4 CONTRAINDICATIONS AND UNWANTED SIDE
EFFECTS 13
2.5 USERS AND INSTALLERS 13
2.5.1 USER TRAINING 13
2.5.2 INSTALLER TRAINING 13
3. REFERENCE STANDARDS 13
4. INTRODUCTION 13
4.1 USING THE MANUAL 13
4.2 DEVICE LABELLING AND TRACEABILITY 13
4.3 SYMBOLS 14
4.4 WARRANTY AND SERVICE 14
5. WARNINGS/DANGERS 14
6. SPECIFIC WARNINGS 15
7. RESIDUAL RISK 15
8. TECHNICAL DATA AND COMPONENTS 15
9. COMMISSIONING 15
10. OPERATING CHARACTERISTICS 15
11. PROPER USE 16
11.1 APPLYING THE BELTS 16
12. CLEANING AND MAINTENANCE 16
12.1 CLEANING 16
12.2 ROUTINE MAINTENANCE 16
12.3 PERIODIC OVERHAUL 16
12.4 SPECIAL MAINTENANCE 16
12.5 LIFE SPAN 17
13. TROUBLESHOOTING TABLE 17
14. ACCESSORIES 17
15. SPARE PARTS 17
16. DISPOSAL 17
1. MODELLE 18
2. VERWENDUNGSZWECK 18
2.1 VERWENDUNGSZWECK UND KLINISCHER
NUTZEN 18
2.2 ZIELPATIENTEN 18
2.3 AUSWAHLKRITERIEN FÜR PATIENTEN 18
2.4 GEGENANZEIGEN UND UNERWÜNSCHTE
NEBENWIRKUNGEN 18
2.5 ANWENDER UND TECHNIKER 18
2.5.1 ANWENDERAUSBILDUNG 18
2.5.2 AUSBILDUNG INSTALLATEUR 18
3. BEZUGSRICHTLINIEN 18
4. EINLEITUNG 18
4.1 GEBRAUCH DES HANDBUCHS 18
4.2 TYPENSCHILDER UND RÜCKVERFOLGBARKEIT
DES PRODUKTS 18
5. WARNUNGEN/GEFAHREN 19
6. SPEZIFISCHE HINWEISE 20
7. RESTRISIKO 20
8. TECHNISCHE DATEN UND KOMPONENTEN 20
9. INBETRIEBNAHME 20
10. ANWENDUNGSEIGENSCHAFTEN 21
11. GEBRAUCHSWEISE 21
11.1 ANWENDUNG DER GURTE 21
12. REINIGUNG UND WARTUNG 21
12.1 REINIGUNG 21
12.2 ORDENTLICHE WARTUNG 21
12.3 REGELMÄSSIGE REVISION 22
12.4 AUSSERORDENTLICHE WARTUNG 22
12.5 LEBENSDAUER 22
13. SCHADENSTABELLE 22
14. ZUBEHÖR 22
15. ERSATZTEILE 22
16. ENTSORGUNG 22
1. MODÈLES 23
2. UTILISATION 23
2.1 UTILISATION ET BÉNÉFICES CLINIQUES 23
2.2 PATIENTS DESTINATAIRES 23
2.3 CRITÈRES DE SÉLECTION DES PATIENTS 23
 
COLLATÉRAUX INDÉSIRABLES 23
2.5 UTILISATEURS ET INSTALLATEURS 23
2.5.1 FORMATION DES UTILISATEURS 23
2.5.2 FORMATION INSTALLATEUR 23
3. STANDARD DE RÉFÉRENCE 23
4. INTRODUCTION 23
4.1 UTILISATION DU MANUEL 23
4.2 ÉTIQUETAGE ET CONTRÔLE DE LA
TRAÇABILITÉ DU DISPOSITIF 23
5. AVERTISSEMENTS/DANGERS 24
6. AVERTISSEMENTS SPÉCIFIQUES 25
7. RISQUE RÉSIDUEL 25
8. DONNÉES TECHNIQUES ET COMPOSANTS 25
9. MISE EN SERVICE 25
10. CARACTÉRISTIQUES FONCTIONNELLES 26
11. MODALITÉS D’UTILISATION 26
11.1 APPLICATION DES SANGLES 26
12. NETTOYAGE ET ENTRETIEN 26
12.1 NETTOYAGE 26
12.2 ENTRETIEN ORDINAIRE 26
12.3 RÉVISION PÉRIODIQUE 27
DE
FR
EN
IT
3

EL
12.4 ENTRETIEN EXTRAORDINAIRE 27
12.5 DURÉE DE VIE 27
13. TABLEAU DE GESTION DES PANNES 27
14. ACCESSOIRES 27
15. PIÈCES DÉTACHÉES 27
16. ÉLIMINATION 27
1. MODELOS 28
2. DESTINO DE USO 28
2.1 DESTINO DE USO Y BENEFICIOS CLÍNICOS 28
2.2 PACIENTES DESTINATARIOS 28
2.3 CRITERIOS DE SELECCIÓN DE LOS PACIENTES 28
2.4 CONTRAINDICACIONES Y EFECTOS
COLATERALES NO DESEADOS 28
2.5 USUARIOS Y ENCARGADOS DE SU
COLOCACIÓN 28
2.5.1 FORMACIÓN DE LOS USUARIOS 28
2.5.2 FORMACIÓN DEL INSTALADOR 28
3. NORMAS DE REFERENCIA 28
4. INTRODUCCIÓN 28
4.1 USO DEL MANUAL 28
4.2 ETIQUETADO Y CONTROL DE SEGUIMIENTO
DEL DISPOSITIVO 28
4.3 SÍMBOLOS 29
4.4 GARANTÍA Y ASISTENCIA 29
5. ADVERTENCIAS/PELIGROS 29
6. ADVERTENCIAS ESPECÍFICAS 30
7. RIESGO RESIDUAL 30
8. DATOS TÉCNICOS Y COMPONENTES 30
9. PUESTA EN FUNCIONAMIENTO 30
10. CARACTERÍSTICAS DE FUNCIONAMIENTO 31
11. MODO DE USO 31
11.1 APLICACIONES DE LOS CINTURONES 31
12. LIMPIEZA Y MANTENIMIENTO 31
12.1 LIMPIEZA 31
12.2 MANTENIMIENTO ORDINARIO 31
12.3 REVISIÓN PERIÓDICA 32
12.4 MANTENIMIENTO EXTRAORDINARIO 32
12.5 TIEMPO DE VIDA ÚTIL 32
13. TABLA DE GESTIÓN DE FALLAS 32
14. ACCESORIOS 32
15. RECAMBIOS 32
16. ELIMINACIÓN 32
1. MODELOS 33
2. USO PRETENDIDO 33
2.1 USO PRETENDIDO E BENEFÍCIOS CLÍNICOS 33
2.2 PACIENTES DESTINATÁRIOS 33
2.3 CRITÉRIOS DE SELEÇÃO DOS PACIENTES 33
2.4 CONTRAINDICAÇÕES E EFEITOS COLATERAIS
INDESEJADOS 33
2.5 UTILIZADORES E INSTALADORES 33
2.5.1 FORMAÇÃO DOS UTILIZADORES 33
2.5.2 FORMAÇÃO DO INSTALADOR 33
3. NORMATIVA DE REFERÊNCIA 33
4. INTRODUÇÃO 33
4.1 UTILIZAÇÃO DO MANUAL 33
4.2 ETIQUETAGEM E CONTROLO DA
RASTREABILIDADE DO PRODUTO 33
4.3 SÍMBOLOS 34
4.4 GARANTIA E ASSISTÊNCIA 34
5. ADVERTÊNCIAS/PERIGOS 34
6. ADVERTÊNCIAS ESPECÍFICAS 35
7. RISCO RESIDUAL 35
8. DADOS TÉCNICOS E COMPONENTES 35
9. COLOCAÇÃO EM FUNÇÃO 35
10. CARACTERÍSTICAS FUNCIONAIS 35
11. MODO DE UTILIZAÇÃO 36
11.1 APLICAÇÃO DOS CINTOS 36
12. LIMPEZA E MANUTENÇÃO 36
12.1 LIMPEZA 36
12.2 MANUTENÇÃO ORDINÁRIA 36
12.3 REVISÃO PERIÓDICA 36
12.4 MANUTENÇÃO EXTRAORDINÁRIA 36
12.5 VIDA ÚTIL 37
13. TABELA PARA A RESOLUÇÃO DE PROBLEMAS 37
14. ACESSÓRIOS 37
15. PEÇAS SOBRESSALENTES 37
16. ELIMINAÇÃO 37
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PT
ES
4
1. MODELE 43
2. DOMENIUL DE UTILIZARE 43
 
BENEFICIILE CLINICE 43
  
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 
NEDORITE 43
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2.5.1 FORMAREA UTILIZATORILOR 43
2.5.2 FORMAREA INSTALATORULUI 43
 
4. INTRODUCERE 43
4.1 UTILIZAREA MANUALULUI 43
 
DISPOZITIVULUI 43
4.3 SIMBOLURI 44
  
5. AVERTISMENTE/PERICOLE 44
6. AVERTISMENTE SPECIFICE 45
7. RISC REZIDUAL 45
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9. UTILIZAREA 45
 
11. MOD DE UTILIZARE 46
11.1 APLICAREA CENTURILOR 46
  
  
  
  
 
  
 
14. ACCESORII 47
15. PIESE DE SCHIMB 47
16. ELIMINAREA 47
1. MODELY 48
 
 
  
  
 
  
 
INSTALACI 48
 
 
  
  
  
  
 
  
4.4 ZÁRUKA A SERVIS 49
  
6. SPECIFICKÁ VAROVÁNÍ 50
7. ZBYTKOVÉ RIZIKO 50
  
  
  
 
  
  
  
  
 
RO
CS
INDHOLDSFORTEGNELSE
 
  
13. TABULKA PORUCH 52
 
15. NÁHRADNÍ DÍLY 52
16. LIKVIDACE 52
  
  
  
 
 
  
 
  
  
  
  
 
  
  
 
 
  
 
  
 
  
  
  
 
  
  
  
  
  
 
  
  
 
 
  
  
 
1. MODELLER 58
2. ANVENDELSESFORMÅL 58
2.1 PÅTÆNKT ANVENDELSE OG KLINISKE
FORDELE 58
2.2 MODTAGERPATIENTER 58
2.3 UDVÆLGELSESKRITERIER FOR PATIENTER 58
2.4 KONTRAINDIKATIONER OG BIVIRKNINGER 58
2.5 BRUGERE OG INSTALLATØRER 58
2.5.1 BRUGERTRÆNING 58
2.5.2 UDDANNELSE AF INSTALLATØR 58
3. REFERENCESTANDARD 58
4. INDLEDNING 58
4.1 BRUG AF DENNE VEJLEDNING 58
4.2 ENHEDENS MÆRKNING OG SPORBARHED 58
4.3 SYMBOLER 59
4.4 GARANTI OG TEKNISK ASSISTANCE 59
5. ADVARSLER/FARER 59
6. SPECIFIKKE ADVARSLER 60
7. RESTERENDE RISIKO 60
8. TEKNISKE DATA OG KOMPONENTER 60
9. IDRIFTSÆTTELSE 60
BG
DA
5
HAKEMISTO / INHOUDSOPGAVE / INNHOLDSFORTEGNELSE
NO
10. FUNKTIONELLE EGENSKABER 61
11. ANVENDELSE 61
11.1 ANVENDELSE AF BÆLTERNE 61
12. RENGØRING OG VEDLIGEHOLDELS 61
12.1 RENGØRING 61
12.2 RUTINEMÆSSIG VEDLIGEHOLDELSE 61
12.3 PERIODISK GENNEMGANG 61
12.4 EKSTRAORDINÆR VEDLIGEHOLDELSE 62
12.5 LEVETID 62
 
14. TILBEHØR 62
15. RESERVEDELE 62
16. BORTSKAFFELSE 62
1. MALLIT 63
2. YTTÖTARKOITUS 63
2.1 YTTÖTARKOITUS JA KLIINISET HYÖDYT 63
2.2 KOHDEPOTILAAT 63
2.3 POTILAIDEN VALINTAKRITEERIT 63
 
SIVUVAIKUTUKSET 63
2.5 YTTÄJÄT JA ASENTAJAT 63
2.5.1 YTTÄJIEN KOULUTUS 63
2.5.2 ASENTAJAN KOULUTUS 63
3. VIITEDIREKTIIVI 63
  
4.1 OPPAAN KÄYTTÖ 63
4.2 ETIKETÖINTI JA LAITTEEN JÄLJITETTÄVYYDEN
TARKASTUS 63
4.3 SYMBOLIT 64
4.4 TAKUU JA HUOLTO 64
5. VAROITUKSET/VAARAT 64
6. ERITYISET VAROITUKSET 65
  
  
9. YTTÖÖNOTTO 65
10. TOIMINNALLISET OMINAISUUDET 66
11. KÄYTTÖTAPA 66
11.1 HIHNOJEN KÄYTTÖ 66
  
12.1 PUHDISTUS 66
12.2 MÄÄRÄAIKAISHUOLTO 66
12.3 SÄÄNNÖLLINEN TARKASTUS 66
12.4 YLIMÄÄRÄINEN HUOLTO 67
12.5 KÄYTI 67
13. VIANMÄÄRITYSTAULUKKO 67
14. LISÄVARUSTEET 67
15. VARAOSAT 67
16. HÄVITTÄMINEN 67
1. MODELLEN 68
2. GEBRUIKSBESTEMMING 68
2.1 GEBRUIKSBESTEMMING EN KLINISCHE
VOORDELEN 68
2.2 DOELGROEP PATIËNTEN 68
2.3 KEUZECRITERIA PATIËNTEN 68
 
BIJWERKINGEN 68
2.5 GEBRUIKERS EN INSTALLATEURS 68
2.5.1 TRAINING VAN DE GEBRUIKERS 68
2.5.2 TRAINING VAN DE INSTALLATEUR 68
3. REFERENTIENORM 68
4. INLEIDING 68
4.1 GEBRUIK VAN DE HANDLEIDING 68
4.2 ETIKETTERING EN
TRACEERBAARHEIDSCONTROLE VAN
HET HULPMIDDEL 68
4.3 SYMBOLEN 69
4.4 GARANTIE EN ASSISTENTIE 69
5. WAARSCHUWINGEN/GEVAREN 69
6. SPECIFIEKE WAARSCHUWINGEN 70
7. RESTRISICO 70
8. TECHNISCHE GEGEVENS EN COMPONENTEN 70
9. INGEBRUIKNAME 70
10. FUNCTIONELE EIGENSCHAPPEN 71
11. GEBRUIK 71
11.1 BANDTOEPASSING 71
12. REINIGING EN ONDERHOUD 71
12.1 REINIGING 71
12.2 ROUTINEONDERHOUD 71
12.3 PERIODIEKE REVISIE 72
12.4 BUITENGEWOON ONDERHOUD 72
12.5 LEVENSDUUR 72
13. TABEL BEHEER DEFECTEN 72
14. ACCESSOIRES 72
15. ONDERDELEN 72
 
1. MODELLER 73
2. BRUKSFORMÅL 73
2.1 BRUKSFORMÅL OG KLINISKE FORDELER 73
2.2 PASIENTBRUKERE 73
2.3 KRITERIER FOR VALG AV PASIENTER 73
2.4 KONTRAINDIKASJONER OG UØNSKEDE
BIVIRKNINGER 73
2.5 BRUKERE OG INSTALLATØRER 73
2.5.1 OPPLÆRING AV BRUKERE 73
2.5.2 OPPLÆRING AV INSTALLATØR 73
3. REFERANSESTANDARD 73
  
4.1 BRUK AV VEILEDNINGEN 73
4.2 MERKING OG KONTROLL OG SPORING
AV INNRETNINGEN 73
4.3 SYMBOLER 74
4.4 GARANTI OG ASSISTANSE 74
5. ADVARSLER/FARER 74
6. SPESIFIKKE ADVARSLER 75
7. RESTRISIKO 75
8. TEKNISKE DATA OG KOMPONENTER 75
  
  
11. BRUKSMÅTE 76
11.1 PÅFØRING AV BELTENE 76
 
12.1 RENGJØRING 76
12.2 ORINDÆRT VEDLIKEHOLD 76
12.3 REGELMESSIG REVISJON 76
12.4 EKSTRAORDINÆRT VEDLIKEHOLD 77
12.5 LEVETID 77
13. FEILSØKINGSTABELL 77
14. TILBEHØR 77
15. RESERVEDELER 77
16. KASSERING 77
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1. MODELLER 78
2. ANVÄNDNINGSOMRÅDE 78
2.1 AVSEDD ANVÄNDNING OCH
KLINISKA FÖRDELAR 78
2.2 ANVÄNDANDE PATIENTGRUPP 78
2.3 PATIENTURVALSKRITERIER 78
2.4 KONTRAINDIKATIONER OCH OÖNSKADE
BIVERKNINGAR 78
2.5 ANVÄNDARE OCH INSTALLATÖRER 78
2.5.1 ANVÄNDARUTBILDNING 78
2.5.2 INSTALLATÖRSUTBILDNING 78
3. REFERENSSTANDARDER 78
4. INLEDNING 78
4.1 ANVÄNDNING AV HANDBOKEN 78
4.2 ENHETSMÄRKNING OCH
SPÅRBARHETSKONTROLL 78
4.3 SYMBOLER 79
4.4 GARANTI OCH ASSISTANS 79
5. VARNINGAR/ FAROR 79
6. SÄRSKILDA VARNINGAR 80
7. KVARVARANDE RISKER 80
8. TEKNISKADATA OCH KOMPONENTER 80
9. IDRIFTTAGNING 80
10. FUNKTIONSEGENSKAPER 81
11. ANVÄNDNINGSSÄTT 81
11.1 PÅSÄTTNING AV BÄLTEN 81
12. RENGÖRING OCH UNDERHÅLL 81
12.1 RENGÖRING 81
12.2 ODINARIE UNDERHÅLL 81
12.3 PERIODISK ÖVERSYN 81
12.4 SÄRSKILT UNDERHÅLL 82
12.5 LIVSLÄNGD 82
13. FELHANTERINGSTABELL 82
14. TILLBEHÖR 82
15. RESERVDELAR 82
16. KASSERING 82
1. MODELI 83
2. NAMENA 83
 
PREDNOSTI 83
2.2 PACIJENITI KOJIMA SU NAMENJENE 83
2.3 KRITERIJUMI ZA ODABIR PACIJENATA 83
 
2.5 KORISNICI I INSTALATERI 83
2.5.1 OBUKA KORISNIKA 83
2.5.2 OBUKA INSTALATERA 83
3. REFERENTNI STANDARD 83
4. UVOD 83
4.1 UPOTREBA UPUTSTVA 83
 
SLEDLJIVOSTI 83
4.3 SIMBOLI 84
4.4 GARANCIJA I SERVIS 84
  
  
7. PREOSTALI RIZICI 85
 
  
10. RADNE KARAKTERISTIKE 85
  
11.1 PRIMENA POJASEVA 86
  
  
  
  
  
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
  
  
14. DODATNI PRIBOR 87
15. REZERVNI DELOVI 87
  
   
  
 
IEGUVUMI 88
  
  
  
  
  
  
3. ATSAUCES STANDARTS 88
4. IEVADS 88
  
 
KONTROLE 88
4.3 SIMBOLI 89
4.4 GARANTIJA UN ATBALSTS 89
  
  
  
  
  
  
  
11.1 JOSTU LIETOJUMS 91
 
  
  
  
 
  
  
14. PIEDERUMI 92
  
 
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目录 目录 / 目次目次
1. 型号型号 93
2. 指定用途指定用途 93
2.1 指定用途与临床优势指定用途与临床优势 93
2.2 适用患者适用患者 93
2.3 患者选择标准患者选择标准 93
2.4 禁忌症与副作用禁忌症与副作用 93
2.5 使用者与安装者使用者与安装者 93
2.5.1 使用者培训 93
2.5.2 安装者培训 93
3. 参考标准参考标准 93
4. 介绍介绍 93
4.1 手册的应用手册的应用 93
4.2 设备标签与追踪监控设备标签与追踪监控 93
4.3 符号符号 94
4.4 保修服务 保修服务 94
5. 警告/危险 警告/危险 94
6. 特殊忠告 特殊忠告 94
7. 剩余风险剩余风险 95
8. 技术信息与组件技术信息与组件 95
9. 设备运用设备运用 95
10. 功能特点 功能特点 95
11. 使用方法使用方法 95
11.1 约束带的安装约束带的安装 95
12. 清洁与维护 清洁与维护 96
12.1 清洁清洁 96
12.2 常规维护常规维护 96
12.3 定期检查定期检查 96
12.4 特殊维护 特殊维护 96
12.5 使用寿命使用寿命 96
13. 故障处理表 故障处理表 96
14. 配件配件 96
15. 备件 备件 96
16. 废弃处理 废弃处理 96
1. モデル モデル 97
2. 用途用途 97
2.1 用途および臨床上の利点 97
2.2 対象となる患者 97
2.3 患者選別基準 97
2.4 禁忌および副作用 97
2.5 使用者および設置者 97
2.5.1 使用者のトレーニング 97
2.5.2 設置者のトレーニング 97
3. 参照標準 参照標準 97
4. はじめにはじめに 97
4.1 取扱説明書の使用 97
4.2 装置のラベルおよびトレーサビリティの管理
97
4.3 シンボル 98
4.4 保証およびアシスタンス 98
5. 注意事項/危険 注意事項/危険 98
6. 特殊注意事項特殊注意事項 99
7. 残留リスク 残留リスク 99
8. 技術および部品データ技術および部品データ 99
9. 始動 始動 99
10. 機能特性 機能特性 100
11. 使用方法使用方法 100
11.1 ベルトの取り付け 100
12. 清掃およびメンテナンス清掃およびメンテナンス 100
12.1 清掃 100
12.2 定期メンテナンス 100
12.3 定期点検 100
12.4 特別メンテナンス 100
12.5 耐用期間 101
13. 故障管理表故障管理表 101
14. 付属品 付属品 101
15. 交換部品 交換部品 101
16. 廃棄 廃棄 101
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1. MODELLI
I modelli base riportati di seguito possono essere soggetti a implementazioni o modifiche senza preavviso.
• T-Straps • Pin Straps • Reflex Straps • ECS Straps • Rock Straps • RSP Straps
2. DESTINAZIONE D’USO
2.1 DESTINAZIONE D’USO E BENEFICI CLINICI
Le cinture di trattenuta integrale sono ausili da utilizzarsi per immobilizzare il paziente su tavole spinali Spencer.
2.2 PAZIENTI DESTINATARI
Non sono presenti particolari indicazioni legate al gruppo di pazienti.


2.3 CRITERI DI SELEZIONE PAZIENTI

2.4 CONTROINDICAZIONI ED EFFETTI COLLATERALI INDESIDERATI

2.5 UTILIZZATORI E INSTALLATORI

I dispositivi non sono destinati ad utilizzatori profani.
Le cinture di trattenuta integrale sono un dispositivo destinato esclusivamente all’uso professionale. Non consentire a persone non addestrate di aiutare durante l’uso del

       

Le migliori istruzioni sono la continua pratica d’uso sotto la supervisione di personale competente e preparato

prima della definizione dei ruoli nell’impiego del dispositivo.
Gli operatori devono essere in grado di fornire la necessaria assistenza al paziente.
2.5.1 FORMAZIONE UTILIZZATORI
•    


• 
• 
luogo. Tale documentazione deve essere mantenuta almeno per 10 anni dal fine vita del prodotto e deve essere messa a disposizione delle Autorità competenti e/o del
Fabbricante, quando richiesto. In mancanza, gli organi preposti applicheranno eventuali sanzioni previste.
• 
Nota: Spencer Italia S.r.l. si ritiene sempre a disposizione per lo svolgimento di corsi di formazione.
2.5.2 FORMAZIONE INSTALLATORE

3. STANDARD DI RIFERIMENTO
 


RIFERIMENTO TITOLO DEL DOCUMENTO
 Regolamento UE relativo ai Dispositivi Medici
4. INTRODUZIONE
4.1 UTILIZZO DEL MANUALE
-
sitivo.
Nota: il Manuale è parte integrante del dispositivo, pertanto deve essere conservato per tutta la durata del dispositivo e dovrà accompagnare lo stesso in eventuali cambi di
destinazione o di proprietà. Nel caso in cui fossero presenti istruzioni d’uso relative ad altro prodotto, diverso da quello ricevuto, è necessario contattare immediatamente il
Fabbricante prima dell’uso.
http://support.spencer.it

                    

4.2 ETICHETTATURA E CONTROLLO TRACCIABILITÀ DEL DISPOSITIVO

Questa non deve essere mai rimossa o coperta.

Qualora non si riesca a risalire al lotto/SN assegnato è necessario effettuare il ricondizionamento del dispositivo, previsto solo sotto la responsabilità del fabbricante.


stato consegnato direttamente da Spencer Italia S.r.l. registrare il dispositivo all’indirizzo http://service.spencer.it
SV
9
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
4.3 SIMBOLI
Simbolo Significato Simbolo Significato


situazione direttamente connessa a lesioni gravi o letali
Dispositivo medico Consultare il manuale d’uso
Fabbricante Numero di lotto
Data di fabbricazione Codice del prodotto
 


Identificativo della produzione

 
000 progressivo GS1
6 numero di controllo
 
 
4.4 GARANZIA E ASSISTENZA
un anno a partire dalla data dell’acquisto.

service@spencer.it.

Condizioni di garanzia e assistenza sono disponibili al sito http://support.spencer.it.
Nota: Registrare e conservare con queste istruzioni: lotto (LOT) o matricola (SN) se presente, luogo e data di acquisto, data primo utilizzo, data controlli, nome degli utilizzatori
e commenti.
5. AVVERTENZE/PERICOLI

-
mente consultabili sul sito www.spencer.it nella pagina dedicata al prodotto.
Funzionalità prodotto



-

danni provocati dal prodotto stesso; inoltre si rendono nulle la marcatura CE e la garanzia del prodotto

• 
non conforme deve essere messo fuori uso.
• 
• Evitare il contatto con oggetti taglienti o abrasivi.
• 
Stoccaggio
• 
riparo dalla luce e dal sole.
• 
• 
• 
Requisiti regolatori
 


• 

• 

• Partecipare al controllo di sicurezza del prodotto

• 

• 


salute dei pazienti e degli utilizzatori.
Avvertenze generali per dispositivi medici

• 

SV
10
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR

Non alterare o modificare arbitrariamente il dispositivo la modifica potrebbe provocarne il funzionamento imprevedibile e danni al paziente o ai soccorritori e

• 
• Seguire le procedure ed i protocolli interni approvati dalla propria organizzazione.
• 
• 
• 
del paziente.
6. AVVERTENZE SPECIFICHE

• 

• Applicare sempre il numero di cinture previsto dal presidio di trasporto in uso.
• -

• 

Effettuare delle simulazioni di soccorso con le cinture applicate al prodotto con cui ne è previsto l’impiego e un carico simulante paziente e accessori, prima
della messa in servizio del dispositivo.


Seguire le procedure approvate dal Servizio Medico d’Emergenza per il posizionamento e il trasporto del paziente.
• Evitare il contatto con oggetti taglienti.
• Seguire le procedure approvate dal Servizio Medico d’Emergenza per l’immobilizzazione e il trasporto del paziente.
• 
• 
7. RISCHIO RESIDUO

8. DATI TECNICI E COMPONENTI
Nota: Spencer Italia S.r.l. si riserva il diritto di apportare modifiche alle specifiche senza darne preavviso.
DESCRIZIONE
1 Moschettoni per Pin
2 Nastri trasversali con strap
3 Nastro longitudinale
4 Nastri a “V”
ROCK STRAPS T-STRAPS REFLEX STRAPS PIN STRAPS ECS STRAPS RSP STRAPS
N° Nastri 10 10 10 10 12 10
Tipo fissaggio Strap Strap Strap 
metallo Strap Strap
Materiale    
metallica  
Peso 600g 800g 600g 1500g 800g 350g
9. MESSA IN FUNZIONE

• L’imballo sia integro e abbia protetto il dispositivo durante il trasporto
• 
• 
• Stato di pulizia del prodotto
• 
• Stato di usura del dispositivo.
• Verificare il corretto scorrimento dei nastri
• 
• Verificare la corretta adesione degli inserti strap


La mancanza delle misure sopra indicate, preclude la sicurezza nell’uso del dispositivo, con il conseguente rischio di danni per il paziente, gli operatori e il dispositivo
stesso.
Per utilizzi successivi, effettuare le operazioni specificate al paragrafo 12.

e contattare il Fabbricante.
SV
11
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
10. CARATTERISTICHE FUNZIONALI

11. MODALITA’ D’USO
            

11.1 APPLICAZIONE DELLE CINTURE


1. Il paziente si trova posizionato su tavola spinale con collare cervicale
2. 
3. 
• 
• 
• 
• 
Prestare sempre la massima attenzione ad eventuali zone che possano aver subito traumi e/o fratture.
4. 
5. -

6.   
problemi respiratori ed addominali;
7. 
medico d’emergenza di riferimento.


corretta applicazione.
12. PULIZIA E MANUTENZIONE


inoltre la garanzia risulta invalidata.
• 
• 

• La frequenza dei controlli è determinata da fattori quali le prescrizioni di legge, il tipo di utilizzo, la frequenza di utilizzo, le condizioni ambientali durante l’uso e lo
stoccaggio.
• 


di riparazione effettuato da soggetti non autorizzati.
• 
deve essere eseguito dal Fabbricante.
• 

• 

12.1 PULIZIA


non usare mai solventi o smacchianti.

L’uso di acqua ad alta pressione deve essere evitato.
Lasciare asciugare perfettamente prima di riporla. Lasciugatura dopo il lavaggio oppure dopo l’utilizzo in ambiente umido deve essere naturale e non forzata; non utilizzare
fiamme o altre fonti di calore diretto.


Nel caso di eventuale disinfezione   

12.2 MANUTENZIONE ORDINARIA






• 
• 
• 
• 



12.3 REVISIONE PERIODICA

SV
12
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
12.4 MANUTENZIONE STRAORDINARIA


12.5 TEMPO DI VITA


massimo ammesso.
13. TABELLA GESTIONE GUASTI
PROBLEMA CAUSA RIMEDIO

al pin presente sulla tavola spinale

dei detriti ne ostacolano l’apertura

-
tare il fabbricante
  Pulire le aree strap e verificarne la corretta adesione.

fabbricante
Nel caso il problema o guasto rilevato non corrisponda a quanto sopra indicato contattare il servizio assistenza Spencer Italia srl.
14. ACCESSORI

15. RICAMBI

16. SMALTIMENTO
  
altrimenti attenersi alle norme vigenti in materia di smaltimento.
Avvertenza


© Copyright Spencer Italia S.r.l.

13
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EN
DE
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FR
RO
ES
CS
PT
NL
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BG
NO
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FI
SR
1. MODELS
The following basic models may be subject to implementation or change without notice.
• T-Straps • Pin Straps • Reflex Straps • ECS Straps • Rock Straps • RSP Straps
2. INTENDED USE
2.1 INTENDED USE AND CLINICAL BENEFITS

2.2 TARGET PATIENTS



2.3 PATIENT SELECTION CRITERIA

2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS

2.5 USERS AND INSTALLERS


     






Operators must be able to provide the necessary patient care.
2.5.1 USER TRAINING
• 

• 
• This docu-
mentation must be kept for at least 10 years after the end of the product’s life and must be made available to the competent authorities and/or the Manufacturer when
requested. In the absence of such documentation, the relevant bodies will apply any foreseen sanctions.
• 
Note: Spencer Italia S.r.l. is always available for training courses.
2.5.2 INSTALLER TRAINING

3. REFERENCE STANDARDS



REFERENCE DOCUMENT TITLE
 EU Regulation on Medical Devices
4. INTRODUCTION
4.1 USING THE MANUAL

Note: The Manual is an integral part of the device and therefore it must be kept for the entire life of the device and must accompany it in any changes of use or ownership. If any
instructions for use for products other than the one received are present, please contact the Manufacturer immediately before use.
http://support.spencer.it

             

4.2 DEVICE LABELLING AND TRACEABILITY



If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.


http://service.spencer.it
14
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
4.3 SYMBOLS
Symbol Meaning Symbol Meaning



Medical device 
Manufacturer Lot number
Date of manufacture Product code
 


Production identification

 
000 progressive GS1
6 control number
 
 
4.4 WARRANTY AND SERVICE
one year from the date of purchase.

service@spencer.it.

Warranty and service conditions are available at http://support.spencer.it.
Note: Record and keep with these instructions: lot (LOT) or serial number (SN), if present, place and date of purchase, date of first use, date of checks, user name and comments.
5. WARNINGS/DANGERS

www.
spencer.it
Product features

-





• 
service.
• 
• 
• 
Storage
• 

• 
• 
• 
Regulatory requirements



• 

• -

• Participate in safety checks on products

• 

• 


of patients and users.
General warnings for medical devices

• 
15
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR

-

• 
• 
• 
• 
• 

6. SPECIFIC WARNINGS

• 

• 
• 

• 

Perform rescue simulations with the belts applied to the product with which it is intended to be used and a patient simulating load and accessories before
putting the device into service.



• 
• 
• 
• 
7. RESIDUAL RISK

8. TECHNICAL DATA AND COMPONENTS
Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.
DESCRIPTION
1 Spring catches for Pins
2 Transversal belts with strap
3 Longitudinal belt
4 V-belts
ROCK STRAPS T-STRAPS REFLEX STRAPS PIN STRAPS ECS STRAPS RSP STRAPS
No. Belts 10 10 10 10 12 10
 Strap Strap Strap 
 Strap Strap
Material    
  
 600g 800g 600g 1500g 800g 350g
9. COMMISSIONING

• 
• 
• 
• Product cleanliness
• 
• 
• 
• 
• 


Failure to take the above measures will preclude safe use of the device, resulting in risk of damage to the patient, operators and the device itself.
For subsequent use, perform the operations specified in paragraph 12.

10. OPERATING CHARACTERISTICS

16
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
11. PROPER USE


11.1 APPLYING THE BELTS


1. 
2. 
3. 
• 
• 
• 
• 
Always be extremely careful with any areas that may have suffered trauma and/or fractures.
4. 
5. 

6. 
and abdominal problems;
7. 

 

12. CLEANING AND MAINTENANCE



• 
• 

• The frequency of inspections is determined by factors such as legal requirements, type of use, frequency of use, and environmental conditions during use and storage.
•                 


parties.
• 
Manufacturer.
• 

• -

12.1 CLEANING



soap. Never use solvents or stain removers.
Avoid using high
pressure water.

If disinfecting


12.2 ROUTINE MAINTENANCE
                      





• 
• 
• 
• 



12.3 PERIODIC OVERHAUL

12.4 SPECIAL MAINTENANCE


17
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
12.5 LIFE SPAN


13. TROUBLESHOOTING TABLE
PROBLEM CAUSE REMEDY







  
-
facturer.
If a problem or fault is detected that does not correspond to the above, please contact Spencer Italia srl customer care service.
14. ACCESSORIES

15. SPARE PARTS

16. DISPOSAL


Warning


© Copyright Spencer Italia S.r.l.

18
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1. MODELLE
Die nachfolgenden Basismodelle können ohne Vorankündigung ergänzt oder geändert werden.
• T-Straps • Pin Straps • Reflex Straps • ECS Straps • Rock Straps • RSP Straps
2. VERWENDUNGSZWECK
2.1 VERWENDUNGSZWECK UND KLINISCHER NUTZEN

2.2 ZIELPATIENTEN

  

2.3 AUSWAHLKRITERIEN FÜR PATIENTEN

2.4 GEGENANZEIGEN UND UNERWÜNSCHTE NEBENWIRKUNGEN

2.5 ANWENDER UND TECHNIKER




              


-

Die Rettungskräfte müssen in der Lage sein, dem Patienten im Bedarfsfall beistehen zu können.
2.5.1 ANWENDERAUSBILDUNG
• -


• 
• 
Datum und Ort angegeben sind. 
Behörden und/oder dem Hersteller auf Anfrage zur Verfügung gestellt werden. Geschieht dies nicht, werden von den zuständigen Stellen entsprechende Sanktionen
erhoben.
• 
Hinweis: Spencer Italia S.r.l. steht immer zur Durchführung von Ausbildungskursen zur Verfügung.
2.5.2 AUSBILDUNG INSTALLATEUR

3. BEZUGSRICHTLINIEN
                   
   


BEZUG TITEL DES DOKUMENTS
 
4. EINLEITUNG
4.1 GEBRAUCH DES HANDBUCHS


Hinweis: Das Handbuch ist fester Bestandteil des Geräts. Es muss daher für die gesamte Lebensdauer aufbewahrt werden und muss dem Gerät bei etwaigem Wechsel des
Bestimmungsortes oder des Eigentümers beiliegen. Falls Gebrauchsanweisungen vorliegen, die sich auf ein Produkt beziehen, das von dem gelieferten abweicht, muss sich vor
der Anwendung sofort an den Hersteller gewendet werden. .
http://support.spencer.it




4.2 TYPENSCHILDER UND RÜCKVERFOLGBARKEIT DES PRODUKTS


 

Falls die zugewiesene Losnummer/SN nicht mehr feststellbar ist, muss das Gerät überholt werden, wozu nur der Herstellers verantwortlich ist.


http://service.spencer.it

19
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
4.3 SYMBOLE
Symbol Bedeutung Symbol Bedeutung



 
Hersteller Losnummer
Herstellungsdatum Produktcode
          






000 fortlaufende GS1



4.4 GARANTIE UND KUNDENDIENST


[email protected].


Die Garantie- sowie Kundendienstbedingungen sind auf der Internetseite http://support.spencer.it
Hinweis: Vermerken und mit diesen Anweisungen aufbewahren: Los- (LOT) oder Seriennummer (SN), falls vorhanden, Ort und Datum des Kaufs, Datum des ersten Gebrauchs,
Prüfdatum, Benutzername und Kommentare.
5. WARNUNGEN/GEFAHREN


Internetseite www.spencer.it
Gebrauchsweise des Produkts







• 

• 
• 
• 
Lagerung
• 

• 
• 
• 
Regulatorische Anforderungen
                   
   


• 


• 
-

• Teilnahme an der Sicherheitsprüfung des in Verkehr gebrachten Produkts

• -

• 

-

20
SV
IT
EN
DE
EL
FR
RO
ES
CS
PT
NL
LV
BG
NO
ZH
DA
JA
FI
SR
Allgemeine Hinweise zu medizinischen Geräten

• 




• 
• 
• 
• 
• 

6. SPEZIFISCHE HINWEISE

• 

• 
• 

• 

Mit den Gurten, die am für den Einsatz vorgesehenen Produkt angebracht sind, Rettungssimulationen und einer den Patienten simulierenden Last und Zubehör
durchzuführen.




• 
• 
• 
• 
7. RESTRISIKO

8. TECHNISCHE DATEN UND KOMPONENTEN
Hinweis: Spencer Italia S.r.l. behält sich das Recht vor, ohne Vorankündigung Änderungen anzubringen. .
BESCHREIBUNG
1 Karabinerhaken für Stifte
2 Querbänder mit Strap
3 Längsband
4 V-Bänder
ROCK STRAPS T-STRAPS REFLEX STRAPS PIN STRAPS ECS STRAPS RSP STRAPS
 10 10 10 10 12 10
Befestigungsart Strap Strap Strap 
aus Metall Strap Strap
Material    
Metalllegierung  
 600g 800g 600g 1500g 800g 350g
9. INBETRIEBNAHME

• 
• 
• 
• Reinigungszustand des Produkts
• 
• 
• 
• 
• 


Werden die oben genannten Maßnahmen unterlassen, ist die Sicherheit beim Gebrauch des Geräts nicht gegeben, woraus sich ein Schadensrisiko für den Patienten,
die Einsatzkräfte und das Gerät selbst ergeben kann.
Für spätere Anwendungen die unter Absatz 12 angegebenen Maßnahmen ausführen.
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laerdal BaXstrap Spineboard Mode d'emploi

Taper
Mode d'emploi