Stryker F-SFFFBER, Instructions For Use Manual

Page: 35 / 198

使用说明
Document Number: D-720743
页码
35
Issue Date: 15 APR 2020
Version: C Ref Blank Template: 80025118 Ver. E
目录
Spine System (F-SFFFBER)
1.
一般信息
............................................................................................................................... 37
版权声明：
................................................................................................................37
商标：
.......................................................................................................................37
联系信息：
................................................................................................................38
安全注意事项：
.........................................................................................................38
1.4.1
安全危险标志说明：
........................................................................................38
1.4.2
设备误用说明：
...............................................................................................38
1.4.3
用户和
/
或患者通知：
.......................................................................................38
1.4.4
安全弃置：
......................................................................................................38
操作系统：
................................................................................................................39
1.5.1
适用符号：
......................................................................................................39
1.5.2
适用用户和患者人群：
....................................................................................40
1.5.3
医疗设备法规符合性：
....................................................................................40
EMC
注意事项：
.......................................................................................................40
EC
授权代表：
..........................................................................................................40
制造信息：
................................................................................................................41
2.
系统
...................................................................................................................................... 41
系统组件标识：
.........................................................................................................41
产品代码和描述：
.....................................................................................................42
附件列表和耗材组件表：
...........................................................................................43
适用范围：
................................................................................................................45
预期用途：
................................................................................................................45
残留风险：
................................................................................................................45