10 — Appendix A
103
10085896_H
V-PRO
®
maX 2
Operator Manual
NOTE: If using a non-STERIS tray or container that has been FDA cleared for use in this Low Temperature
Sterilization System, follow manufacturer’s instructions for preparation and loading.
Device Wraps
Select the proper size wrap for the items to be Sterilized. Use only Low Temperature Sterilization System compatible
polypropylene sterilization wrap (contact STERIS or your local distributor to identify compatible wraps in your market).
Pouches
Use only Low Temperature Sterilization System compatible Tyvek
®
pouches. STERIS has a full line of Vis-U-All
™
Low
Temperature Tyvek pouches and tubing that has been validated for use in the System in either a single- or double-
pouched configuration. Please contact your STERIS representative for further information. Note the following when
using pouches:
• Follow Operating Instructions included with pouches.
• Items may be placed into a second pouch. Never fold inner pouch.
• Place a Celerity HP Chemical Indicator or VERIFY HPU Chemical Indicator inside pouches.
• When placing in Sterilizer, arrange pouches so transparent side of pouch faces the opaque side of the next pouch.
• Do NOT stack pouches on top of each other.
Biological Indicator Challenge Pack
WARNING
BIOHAZARD CONTROL
Use only BIs, CIs, BI Challenge Packs and other system accessories recommended by
STERIS as these items have been validated to assure proper functioning with this Low
Temperature Sterilization System. Ineffective Sterilization Cycle may not be detected
using other system accessories.
Use a validated BI or Challenge Pack for monitoring this Low Temperature Sterilization System. STERIS recommends
using the Celerity
™
20 HP BI (LCB044) or VERIFY
®
V24 Self-Contained BI (LCB020) for routine monitoring of this Low
Temperature Sterilization System’s Cycles. Please contact your STERIS representative for further information. Follow
the BI Instructions For Use.
NOTE: The Challenge Packs are only to be used for installation, relocation and after any major
repairs. Challenge Packs are not to be used for routine monitoring. Major repairs would include:
• Injection cylinder
• Injection assembly replacement
• Pressure transducers (PT1 and PT2)
• Vacuum pump
• Control or control board
• Chamber or door.
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