PETUNJUK PENGGUNAAN
Daftar Isi
Allen™ Counter Traction Brace (90001)
1. Informasi Umum: ................................................................................................................. 82
1.1 Pemberitahuan Hak Cipta: ....................................................................................... 82
1.2 Merek Dagang: .......................................................................................................... 82
1.3 Detail Kontak: .............................................................................................................. 83
1.4 Pertimbangan Keselamatan: ................................................................................... 83
1.4.1 Pemberitahuan simbol bahaya keselamatan: ............................................ 83
1.4.2 Pemberitahuan penyalahgunaan peralatan: ............................................ 83
1.4.3 Pemberitahuan kepada pengguna dan/atau pasien: ............................. 83
1.4.4 Pembuangan yang aman: ............................................................................ 84
1.5 Mengoperasikan sistem: ............................................................................................ 84
1.5.1 Simbol yang Berlaku: ....................................................................................... 84
1.5.2 Populasi Pengguna dan Pasien yang Dituju: ............................................... 85
1.5.3 Kepatuhan dengan peraturan perangkat medis: ..................................... 86
1.6 Pertimbangan EMC: ................................................................................................... 86
1.7 Perwakilan resmi EC: .................................................................................................. 86
1.8 Informasi Produsen: .................................................................................................... 86
1.9 Informasi Importir UE: .................................................................................................. 86
1.10 Sponsor Resmi Australia: ............................................................................................ 86
2. Sistem ................................................................................................................................... 87
2.1 Identifikasi komponen sistem: ................................................................................... 87
2.2 Kode dan Deskripsi Produk: ....................................................................................... 87
2.3 Daftar Tabel Aksesori dan Komponen Habis Pakai: .............................................. 87
2.4 Indikasi penggunaan: ................................................................................................ 88
2.5 Penggunaan yang ditujukan: ................................................................................... 88
3. Penyiapan dan Penggunaan Peralatan: ....................................................................... 88
3.1 Sebelum digunakan: .................................................................................................. 88
3.2 Penyiapan: .................................................................................................................. 88
3.3 Kontrol dan indikator perangkat: ............................................................................. 88
3.4 Petunjuk Penyimpanan, Penanganan, dan Pelepasan: ...................................... 89
3.4.1 Penyimpanan dan Penanganan: ................................................................. 89
Document Number: 80028153
Version C
Halaman 80
Issue Date: 30 MAR 2020
Ref Blank Template: 80025117 Ver. F