使用说明
目录
Universal Patient Braces(F-UPBLC、F-UPBLR、F-UPBL3S)
一般信息 ...........................................................................................................................21
1.1 版权声明: ................................................................................................................21
1.2 商标: .......................................................................................................................21
1.3 联系信息: ................................................................................................................22
1.4 安全注意事项: .........................................................................................................22
1.4.1 安全危险标志说明: ........................................................................................22
1.4.2 设备误用说明: ...............................................................................................22
1.4.3 用户和/或患者通知: .......................................................................................22
1.4.4 安全弃置: ......................................................................................................22
1.5 操作系统: ................................................................................................................23
1.5.1 适用符号: ......................................................................................................23
1.5.2 适用用户和患者人群: ....................................................................................24
1.5.3 医疗器械法规符合性: ....................................................................................24
1.6 EMC 注意事项: .......................................................................................................25
1.7 EC 授权代表: ..........................................................................................................25
1.8 制造信息: ................................................................................................................25
系统 ..................................................................................................................................26
2.1 系统组件标识: .........................................................................................................26
2.2 产品代码和描述: .....................................................................................................26
2.3 附件列表和耗材组件表: ...........................................................................................26
2.4 适用范围: ................................................................................................................27
2.5 预期用途: ................................................................................................................27
2.6 残留风险: ................................................................................................................27
Document Number: 80028299
Version: B
页码 19
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E