PETUNJUK PENGGUNAAN
Daftar Isi
Arm Traction Device (A-20500)
1
Informasi Umum: .......................................................................................................... 115
1.1 Pemberitahuan Hak Cipta: ..................................................................................... 115
1.2 Merek Dagang:......................................................................................................... 115
1.3 Detail Kontak: ............................................................................................................ 116
1.4 Pertimbangan Keselamatan: ................................................................................. 116
1.4.1 Pemberitahuan simbol bahaya keselamatan: .......................................... 116
1.4.2 Pemberitahuan penyalahgunaan peralatan: .......................................... 116
1.4.3 Pemberitahuan kepada pengguna dan/atau pasien: ........................... 116
1.4.4 Pembuangan yang aman: .......................................................................... 117
1.5 Mengoperasikan sistem: .......................................................................................... 117
1.5.1 Simbol yang Berlaku: ..................................................................................... 117
1.5.2 Populasi Pengguna dan Pasien yang Dituju: ............................................. 119
1.5.3 Kepatuhan dengan peraturan perangkat medis:.................................... 119
1.6 Pertimbangan EMC: ................................................................................................. 119
1.7 Perwakilan resmi EC: ................................................................................................ 119
1.8 Informasi Produsen: .................................................................................................. 119
1.9 Informasi Importir UE: ................................................................................................ 120
1.10 Sponsor Resmi Australia: .......................................................................................... 120
2
Sistem ........................................................................................................................... 121
2.1 Identifikasi komponen sistem: ................................................................................. 121
2.2 Kode dan Deskripsi Produk: ..................................................................................... 122
2.3 Daftar Tabel Aksesori dan Komponen Habis Pakai: ............................................ 123
2.4 Indikasi penggunaan: .............................................................................................. 123
2.5 Penggunaan yang ditujukan: ................................................................................. 123
2.6 Risiko Residual: .......................................................................................................... 124
3
Penyiapan dan Penggunaan Peralatan: ................................................................... 124
3.1 Sebelum digunakan: ................................................................................................ 124
3.2 Penyiapan: ................................................................................................................ 124
3.3 Kontrol dan indikator perangkat: ........................................................................... 126
3.4 Petunjuk Penyimpanan, Penanganan, dan Pelepasan: .................................... 126
Document Number: 80028152
Version D
Halaman 113
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F