LYOTK15OPERATION MANUAL操作手册Equipment Name: A utomatic Vacuum Lyophilizer设备名称: 真空冷冻干燥机Equipment model: L YOTK15设备型号：L YOTK15PREFACE前言Thank you for purchasing Truking Lyophilizer.This operation manual introduces how to correctly operate LYOTK15Lyophilizer. Please read this manual carefully and understand safety notice before operation.感谢您购买楚天科技冻干机。
本操作手册介绍了如何正确使用LYOTK15系列冻干机。
在使用该产品前，请务必认真阅读本操作手册，并在理解产品的安全注意事项后再使用该产品Table of contentsT able of contents (3)1 Safety Related Marks 与安全有关的标记说明 (5)1.1 Safety notice 安全注意事项 (5)1.1.1 Before Power-on上电前 (6)1.1.2 Mechanical Safety机械安全 (7)1.1.3 Emergency Stop 紧急停止 (7)1.1.4 Maintenance and Inspection 维护与检查 (8)2 Lyophilizer Introduction 冻干机简介 (9)2.1 Purpose 冻干机用途 (9)2.2 Configuration 冻干机配置 (9)2.3 Control System 冻干机控制系统 (10)3 HMI Operation Description上位机操作说明 (11)3.1 System Introduction 上位机系统简介 (11)3.2 Operation instruction (11)3.2.1 Menu Bar 菜单条 (12)3.2.2 Login登陆 (13)3.2.3 Log out 登出 (14)3.2.4 Flow Chart 流程图 (14)3.2.5 Console 操作台 (16)3.2.6 PID Control Mimic PID控制画面 (30)3.2.7 Alarm mimics报警画面 (31)3.2.8 Trend Mimic曲线画面 (33)3.2.9 Loading and Unloading 进出料画面 (36)3.2.10 Setup Mimic设置画面 (38)3.2.11 Recipe Edit配方编辑 (38)3.2.12 Recipe running 配方运行 (44)3.2.13 PLC Input Status PLC输入状态 (45)3.2.14 PLC Output Status 输出状态 (45)3.2.15 Recorder 记录仪画面 (46)3.2.16 Application 应用画面 (46)3.2.17 Report 报表查询 (48)3.2.18 Maintenance 维护 (49)3.2.19 System Configuration 系统配置 (49)3.2.20 Exit退出 (50)3.2.21 Status Bar 状态条 (50)4 Operation Instruction冻干机操作说明 (52)4.1 Power on 上电 (52)4.2 Manual Control手动控制 (57)4.3 Automatic Control 自动控制 (61)4.3.1 Freeze Drying Cycle冻干周期 (62)4.3.2 Condenser Defrosting冷阱除霜 (65)4.3.3 CIP 在线清洗 (67)4.3.4 SIP在线灭菌 (71)4.3.5 Vacuum Leakage Test 真空泄漏测试 (75)4.3.6 Shelf Bellow Test板层波纹管测试 (77)4.3.7 Main Valve Bellows Iitegrity Test主阀波纹管测试 (78)4.3.8 Unloading Pusher Bellows Test后推波纹管测试 (79)4.3.9 Filter1 integrity test 过滤器1完整性测试 (81)4.3.10 Filter2 integrity test过滤器2完整性测试 (82)5 Operation Instruction of HMI (85)5.1 Manual operation interface (86)5.2 State monitoring interface (87)6 Alarms and Failures Analysis 常见报警及故障分析 (89)6.1 PC Failures PC 故障 (90)6.2 Utility Failures工艺故障 (90)6.3 Instrumentation Failures仪器仪表故障 (91)6.4 Device Failure部件故障 (94)6.4.1 Device State Failure部件状态故障 (94)6.4.2 Device IO Failure元件IO 故障 (97)6.5 Process Failure过程故障 (102)7 Terminology and Abbreviation术语和缩写 (111)1 Safety Related Marks 与安全有关的标记说明This manual uses the following marks based on the safety contents.本手册根据与安全有关的内容，使用了下列标记。
The safety related marks are extremely important to follow.有安全标记的说明，表示重要内容，请务必遵守。
However, even the attention items may cause major accident based on the actualsituation.但是，即使是 事项，根据具体情况，有时也可能导致重大事故。
1.1Safety notice 安全注意事项Incorrect usage may cause injuries or death.表示错误使用时，将会引发危险情况，导致人身伤亡。
Incorrect usage may cause mild or moderate personal injury. Moreover the equipment will be damaged.表示错误使用时，将会引起危险情况，导致轻度或中度人身伤害，损坏设备。
Even items do not belong to “danger” or “attention”, we also mark in the relevant places.即使不属于“危险”或“注意”，但需要用户遵守的事项，也在相关的地方同时进行了标记。
1.1.1 Before Power-on上电前componentsconnect·请务必确保接地端子接地可靠；否则会有引发触电和火灾的危险。
1.1.2 Mechanical Safety机械安全The equipment is designed and manufactured following the ISO 12100 part 1, part 2 and ISO 61508 related mechanical safety standards. The specific risk analysis and solutions please refer to FS Mechanical Safety本设备根据ISO 12100 第1及第2部分、ISO 61508等相关的机械安全标准设计及制造的，具体风险分析及方案请参考FS中机械安全的描述。
1.1.3 Emergency Stop紧急停止Three emergency stop buttons are mounted in the equipment. One is fitted on the control panel of the cabinet and the other in the control box beside the main door in the machine room. The rest one is shared with the loading/unloading system installed in the sterile room. Once any button is pressed, the hardware interlock of the relevant safety circuit (safety switch+safety relay) will cut off theall the control power except the instrument power. All the power equipments will stop and valves will be in original status (single electric control) or current status (double electriccontrol). All the instruments power will be saved to monitor the equipment status and relevant process parameters. Details are as follows:三个急停按钮安装在这台设备上，一个安装在控制柜的控制面板上，一个并联到机器房箱体主门旁边的控制盒，另外一个与手动进出料系统共用安装在无菌室内，任何一个被按下后，相应的安全回路（安全开关+ 安全继电器）的硬件连锁将切断除仪表电源外的所有控制电源，所有的动力设备将停止，阀门将处于原始状态（单电控）或当前状态（双电控）。
所有仪表电源将被保留以监视设备状态及相关的过程参数，具体如下：Emergency Stop Reset：紧急停止复位:After resetting the emergency stop button, alarming confirm button and reset button shall be pressed at the same time. The emergency stop will reset.复位急停开关后，同时按下电控柜面板上“报警确认按钮”及“复位按钮”，紧急停止将复位。