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PETUNJUK PENGGUNAAN
Daftar Isi
Allen
™
C-Flex Polar Head Positioner (A-70701)
1
Informasi Umum: ....................................................................................................... 335
1.1 Pemberitahuan Hak Cipta: ............................................................................... 335
1.2 Merek Dagang: ................................................................................................. 335
1.3 Detail Kontak: .................................................................................................... 336
1.4 Pertimbangan Keselamatan:............................................................................ 336
1.4.1 Pemberitahuan simbol bahaya keselamatan:....................................... 336
1.4.2 Pemberitahuan penyalahgunaan peralatan: ....................................... 336
1.4.3 Pemberitahuan kepada pengguna dan/atau pasien:......................... 336
1.4.4 Pembuangan yang aman: ..................................................................... 337
1.5 Mengoperasikan sistem:.................................................................................... 337
1.5.1 Simbol yang Berlaku: ............................................................................... 337
1.5.2 Populasi Pengguna dan Pasien yang Dituju: ......................................... 338
1.5.3 Kepatuhan dengan peraturan perangkat medis: ................................. 339
1.6 Pertimbangan EMC: .......................................................................................... 339
1.7 Perwakilan resmi EC:.......................................................................................... 339
1.8 Informasi Produsen: ........................................................................................... 339
1.9 Informasi Importir UE: ......................................................................................... 339
1.10Sponsor Resmi Australia: .................................................................................... 339
2
Sistem ........................................................................................................................ 340
2.1 Identifikasi komponen sistem: ........................................................................... 340
2.2 Kode dan Deskripsi Produk:............................................................................... 344
2.3 Daftar Tabel Aksesori dan Komponen Habis Pakai:......................................... 344
2.3.1 Indikasi penggunaan:.............................................................................. 345
2.3.2 Penggunaan yang ditujukan: ................................................................. 345
2.4 Risiko Residual: ................................................................................................... 345
3
Penyiapan dan Penggunaan Peralatan:................................................................ 345
3.1 Sebelum digunakan: ......................................................................................... 345
3.2 Penyiapan:......................................................................................................... 346
3.3 Kontrol dan indikator perangkat:...................................................................... 362
Document Number: 80028169
Version C
Halaman 333
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
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