PETUNJUK PENGGUNAAN
Daftar Isi
Schlein Hand Positioner (A-20750)
1
Informasi Umum: ............................................................................................................... 113
Pemberitahuan Hak Cipta: ................................................................................... 113
Merek Dagang: ...................................................................................................... 113
Detail Kontak: ......................................................................................................... 114
Pertimbangan Keselamatan: ............................................................................... 114
1.4.1 Pemberitahuan simbol bahaya keselamatan: .......................................... 114
1.4.2 Pemberitahuan penyalahgunaan peralatan: .......................................... 114
1.4.3 Pemberitahuan kepada pengguna dan/atau pasien: ........................... 114
1.4.4 Pembuangan yang aman: .......................................................................... 115
Mengoperasikan sistem: ....................................................................................... 115
1.5.1 Simbol yang Berlaku: ..................................................................................... 115
1.5.2 Populasi Pengguna dan Pasien yang Dituju: ............................................. 117
1.5.3 Kepatuhan dengan peraturan perangkat medis: ................................... 117
Pertimbangan EMC: .............................................................................................. 117
Perwakilan resmi EC: .............................................................................................. 117
Informasi Produsen: ................................................................................................ 117
Informasi Importir UE:.............................................................................................. 118
Informasi sponsor Australia: ................................................................................... 118
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Sistem ................................................................................................................................. 119
Identifikasi komponen sistem: ............................................................................... 119
Kode dan Deskripsi Produk: .................................................................................. 121
Daftar Tabel Aksesori dan Komponen Habis Pakai: .......................................... 121
Indikasi penggunaan:............................................................................................ 122
Penggunaan yang ditujukan: .............................................................................. 122
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Penyiapan dan Penggunaan Peralatan: ..................................................................... 123
Sebelum digunakan: ............................................................................................. 123
Penyiapan: .............................................................................................................. 123
Kontrol dan indikator perangkat: ........................................................................ 124
Petunjuk Penyimpanan, Penanganan, dan Pelepasan: ................................. 124
3.4.1 Penyimpanan dan Penanganan: ............................................................... 124
Document Number: 80028196
Version C
Halaman 111
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F