FDI P2131, Техническое руководство, Страница: 4 / 161

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TABLE OF CONTENTS
SECTION DESCRIPTION PAGE
1 INTRODUCTION 1
1.1 Safety Precautions 1
2 GENERAL INFORMATION 3
2.1 Intended Use and System Design 3
2.2 Specifications and Physical Data 4
2.3 Sterilization Cycles – FDA Cleared 5
2.4 Description of Cycle Phases 6
2.5 Water Supply Quality 7
2.6 Sterility Assurance Products 8
3 OPERATION 9
3.1 Installation, Setup, and Qualification (IQ, OQ, PQ) 11
3.2 Controls and Indicators 29
3.2.1 Chamber Door Operation 30
3.3 Operating Procedure 40
3.3.1 Turning the Sterilizer On 40
3.3.2 Zeroing Gauge Pressure (Barometric Pressure Setup) 41
3.3.3 Running a Normal Sterilization Cycle 41
3.3.4 Running a Performance Test (Vacuum Leak or Bowie ‐ Dick Test) 44
3.3.5 Alarms 46
3.3.6 Maintenance Reminder 47
3.3.7 Status 47
3.3.8 Programmable Cycles 48
3.4 Operational Checklists 50
3.4.1 Testing Total Dissolved Solids (TDS) 55
3.4.2 SWS Deionized Water Cartridge Capacity 55
3.4.3 Testing Free Chlorine Level 56
3.5 Operational Situations and Responses 57
3.6 Alarm Code Troubleshooting Guide 60
3.7 Checklist for Transportation and Storage 69
3.8 Consumable Items List 72
4 MAINTENANCE 73
4.1 Preventive Maintenance 73
4.1.1 Preventive Maintenance Summary 74
4.1.2 2 ‐ Month Preventive Maintenance 75
4.1.3 6 ‐ Month Preventive Maintenance 76
4.1.4 12 ‐ Month Preventive Maintenance 77