
iv
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
Содержание P2131
Страница 121: ... THIS PAGE INTENTIONALLY LEFT BLANK 115 ...
Страница 130: ...SECTION A APPENDIX 124 ...
Страница 131: ...A 1 Swagelok Fitting Installation Instructions 125 ...
Страница 135: ...A 2 PLC Data Sheet 129 ...
Страница 141: ...A 3 VERIFY Product Information 135 ...
Страница 147: ...A 4 WRS Pump Information 141 ...
Страница 158: ...A 5 Vacuum Leak Test Troubleshooting Guide 152 ...