Publicité
UPUTE ZA UPOTREBU
Sadržaj
Hip Distraction System (AR-6529S)
Opće informacije ..............................................................................................................74
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1.1 Obavijest o autorskom pravu: ....................................................................................74
1.2 Žigovi: .......................................................................................................................74
1.3 Pojedinosti o kontaktu: ..............................................................................................74
1.4 Sigurnosne napomene: .............................................................................................75
1.4.1 Simbol obavijesti o opasnosti za sigurnost: .....................................................75
1.4.2 Obavijest o pogrešnoj upotrebi opreme: ..........................................................75
1.4.3 Napomena za korisnike i/ili pacijente: .............................................................75
1.4.4 Sigurno odlaganje: ..........................................................................................75
1.5 Upravljanje sustavom: ...............................................................................................76
1.5.1 Primjenjivi simboli: ..........................................................................................76
1.5.2 Predviđeni korisnik i populacija pacijenata: .....................................................77
1.5.3 Sukladnost s propisima o medicinskim proizvodima: .......................................78
1.6 Razmatranja o elektromagnetskoj kompatibilnosti: ....................................................78
1.7 Ovlašteni predstavnik za EU: ....................................................................................78
1.8 Podaci o proizvođaču: ...............................................................................................78
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Sustav ..............................................................................................................................79
2.1 Identifikacija komponenti sustava: .............................................................................79
2.2 Šifra proizvoda i opis: ................................................................................................81
2.3 Popis pribora i tablica potrošnih dijelova: ..................................................................81
2.4 Indikacije za upotrebu: ..............................................................................................82
2.5 Namjena: ..................................................................................................................82
2.6 Preostali rizik: ............................................................................................................83
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Postavljanje i upotreba opreme: .......................................................................................84
3.1 Prije upotrebe: ...........................................................................................................84
3.2 Postavljanje: ..............................................................................................................84
3.3 Kontrole i indikatori uređaja: ......................................................................................95
3.4 Upute o skladištenju, rukovanju i uklanjanju: .............................................................96
3.4.1 Skladištenje i rukovanje: .................................................................................96
3.4.2 Upute za uklanjanje:........................................................................................97
3.5 Smjernice za rješavanje problema: ...........................................................................98
Document Number: 80028286
Version D
Stranica 72
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E
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