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PETUNJUK PENGGUNAAN
Daftar Isi
Basic Rectangular Table, Basic Hourglass Table, Basic Carpa Table (O-AHTR, OAHTH,
O-AHMPT)
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Informasi Umum: ................................................................................................................. 87
Pemberitahuan Hak Cipta: ....................................................................................... 87
Merek Dagang:........................................................................................................... 87
Detail Kontak: .............................................................................................................. 88
Pertimbangan Keselamatan: ................................................................................... 88
1.4.1 Pemberitahuan simbol bahaya keselamatan: ............................................ 88
1.4.2 Pemberitahuan penyalahgunaan peralatan: ............................................ 88
1.4.3 Pemberitahuan kepada pengguna dan/atau pasien: ............................. 88
1.4.4 Pembuangan yang aman: ............................................................................ 89
Mengoperasikan sistem: ............................................................................................ 89
1.5.1 Simbol yang Berlaku: ....................................................................................... 89
1.5.2 Populasi Pengguna dan Pasien yang Dituju: ............................................... 91
1.5.3 Kepatuhan dengan peraturan perangkat medis:...................................... 91
Pertimbangan EMC: ................................................................................................... 91
Perwakilan resmi EC: .................................................................................................. 91
Informasi Produsen: .................................................................................................... 91
Informasi Importir UE: .................................................................................................. 92
Sponsor Resmi Australia: ............................................................................................ 92
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Sistem ................................................................................................................................... 93
Identifikasi komponen sistem: ................................................................................... 93
Kode dan Deskripsi Produk: ....................................................................................... 93
Daftar Tabel Aksesori dan Komponen Habis Pakai: .............................................. 93
Indikasi penggunaan: ................................................................................................ 94
Penggunaan yang ditujukan: ................................................................................... 94
Risiko Residual: ............................................................................................................ 94
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Penyiapan dan Penggunaan Peralatan: ....................................................................... 94
Sebelum digunakan: .................................................................................................. 94
Penyiapan: .................................................................................................................. 95
Kontrol dan indikator perangkat: ............................................................................. 95
Document Number: D-720010/80028133
Version C
Halaman 85
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F
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