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11. TEST PROGRAMS
51
TEST PROGRAMS
INTRODUCTION
To protect the safety of users and patients, a fundamental
process like sterilizing medical
devices should be periodically checked.
In this regard, Millennium B+ offers the possibility of, simply and automatically, executing two
distinct test programs:
• HELIX/BD Test
• Vacuum Test
The HELIX/BD Test program executes a cycle at 134 °C characterized, however, by a
sterilization phase of a particular duration (3.5 min); the cycle has a fractionated vacuum
phase similar to that used in the POROUS and HOLLOW programs.
Using a suitable device, it is possible to evaluate the correct penetration of the steam inside
hollow loads (see the following paragraph).
This cycle is also suitable for measuring the penetration of the steam inside porous loads
(Bowie & Dick test pack).
On the other hand, the Vacuum Test program allows checking the perfect seal of the
sterilizer's entire plumbing system.
By measuring the variation in the degree of vacuum in a certain span of time and comparing it
with pre-set limit values, it is possible to determine the effectiveness of the seal of the
sterilization chamber, the various tubes and the cut-off devices.
HELIX/BD TEST
To select the HELIX/BD Test program, press the Test Selection key one or two times until
the display reads:
HELIX/BD TEST
134.0°C
2.15 bar03:30
The test device (in accordance with the requirements of standard EN 867-5) is a 1.5-m tube
made of PTFE with an internal diameter of 2 mm, with a small sealed screw capsule attached
to one end, capable of holding a suitable amount of chemical. The other end of the tube is left
free to allow the penetration of the steam and evaluate its effectiveness.
To execute the test (in reference to standard EN 13060) insert the chemical indicator, which
consists of a strip of paper with a special reagent ink, inside the capsule of the device (which is
always to be used perfectly dry). Tighten the capsule so that seepage through the gasket seal
will not be possible.
NOTE
T
HE DEVICE AND CHEMICAL INDICATORS FOR RUNNING THE HELIX
/
BD TEST PROGRAM
ARE NOT
SUPPLIED WITH THE DEVICE. TO REQUEST INFORMATION IN THIS REGARD,
CONTACT
M.O.COM.'S CUSTOMER SUPPORT DEPARTMENT (SEE APPENDIX Z).
Place the device on the device's central tray, approximately in the middle. Do not put any
other material inside the chamber.
Close the door and start the program with the START key.
NOTE
I
F A PASSWORD HAS BEEN SET WITH THE
A
NY CYCLE START OPTION (SEE THE
CHAPTER, CONFIGURATION, SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER
THE ACCESS CODE
.
IN ADDITION, THE EQUIPMENT CHECKS THE PRINTER PAPER PRESENCE (OPTIONAL).
THE POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT,
ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE
.
- REVISIONS 3
- TABLE OF CONTENTS 3
- PURPOSE OF THE 8
- MANUAL 8
- GENERAL 8
- WARNINGS 8
- CONTENTS OF 9
- THE PACKAGE 9
- HANDLING THE 10
- PRODUCT 10
- INTRODUCTION 11
- CONTROL 14
- LCD DISPLAY 14
- OPERATING 15
- CYCLE EXAMPLE 15
- INSTALLATION 16
- EXTENSION CORDS 17
- MANAGING THE 18
- FILES BY 18
- MILLFLASH SW 18
- FIRST START-UP 23
- STAND-BY MODE 24
- FILLING DISTILLED 25
- MAX LEVEL IN THE 26
- INTERNAL/ 26
- EXTERNAL DRAIN 26
- CONFIGURATION 27
- MILLENNIUM 28
- DESCRIPTION OF 29
- THE MENU ITEMS 29
- DEFAULTS 31
- SETTINGS 31
- ACTIVATING 31
- OPTIONS 31
- DISABLED+ 32
- 134 °C HOLLOW+ 33
- STANDARD DRYING+ 34
- 134°C PROCESS+ 35
- FRACTION. VACUUM + 35
- SHORT DRYING+ 35
- STANDARD DRYING+ 36
- ST‐ BY MODE+ 37
- OFF+ 37
- PRINTER+ 38
- OFF+ 38
- TYPE 1 + 38
- CR TYPE+ 38
- PRINTOUT MODE+ 39
- AT CYCLE END+ 39
- NORMAL PRINT+ 39
- AUTOMAT. FILLING + 40
- INTERNAL DRAIN+ 40
- EXIT THE 42
- PREPARING THE 43
- MATERIAL 43
- ARRANGING THE 44
- 134°C POROUS 46
- STERILIZATION CYCLE 47
- RUNNING 48
- THE CYCLE 48
- 134°C B CYCLE 49
- Standard drying 52
- Intelligent drying 52
- EXTRA DRYING 52
- (+XX) is the time 52
- RESULT OF THE 53
- CYCLE 53
- CHECK OF THE 54
- CYCLE DATA 54
- REPORT 54
- MANUAL CYCLE 54
- INTERRUPTION 54
- SEE APPENDIX E “ALARMS” 55
- STORING 56
- STERILIZED 56
- MATERIALS 56
- TEST PROGRAMS 57
- PRINTING REPORTS 58
- SUMMARY TABLE 61
- SAFETY DEVICES 62
- WATER SUPPLY CHARACTERISTICS 63
- APPENDIX B – PROGRAMS 64
- APPENDIX B – PROGRAMS 65
- 60 66
- 121c POROUS 69
- 121c HOLLOW 70
- 134c EMERGENCY 73
- 134°C - 3'00'' 73
- VACUUM TEST (VT) 74
- -0.80 bar 74
- EXAMPLES OF PRINTED REPORTS 75
- APPENDIX C – MAINTENANCE 77
- QUALITY DEMINERALIZED 78
- MAINTENANCE 79
- DESCRIPTION 79
- THE COMPONENT 81
- PERIODIC 82
- STERILIZER 82
- VALIDATION 82
- DISPOSAL AT END 82
- PROVIDING THE MODEL 85
- APPENDIX E – ALARMS 86
- RESETTING THE 88
- SYSTEM 88
- ALARM CODES 89
- DICHIARAZIONE DI CONFORMITÀ 97
- TECHNICAL SUPPORT DEPARTMENT 102
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