3 — Installation Verification
16
Operator Manual
V-PRO
®
maX 2
10085896_H
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND/OR EQUIPMENT DAMAGE HAZARD
● Use only Sterilant Cups with Sterilant which has been specially formulated, tested,
and approved for use in this Sterilization System. Use of other sterilants could impair
equipment operation, result in costly repairs, result in an ineffective Sterilization
Cycle and void the equipment warranty.
● Failure to thoroughly clean, rinse and dry articles to be Sterilized could result in an
ineffective Sterilization Cycle.
WARNING
ABORTED CYCLE HAZARD
A leak test is recommended to be performed monthly on the Sterilization Unit to ensure
chamber leak rate is within specification. The leak rate must be less than
0.3 Torr/minute (0.4 mbar/minute or 0.04 kPa/minute). If not, an abort results, door
remains locked and Sterilization Unit service is required.
Read all DANGERS, WARNINGS and CAUTIONS in Safety Precautions of this manual before operating the equipment.
Then complete the following checklist before initial operation of the Low Temperature Sterilization System.
◻ STERIS recommends (in accordance with AAMI ST58, 2013) the room containing the Sterilization Unit has a
ventilation system capable of an air exchange at least 10 times per hour.
◻ STERIS recommends an eye wash station should be located near (within 10 seconds of) the Unit (in accordance
with AAMI ST58, 2013 and OSHA requirements).
◻ A Sterilant Cup is in place; if a Cup is not in place or is empty, install a new Cup as described in Sterilant Cup
Installation and Removal of this manual.
◻ The printer has an adequate paper supply; if a paper roll is not installed or if the paper supply is low, install a new
roll as described in Change Printer Paper Roll Section of this manual. If electronic record keeping is used, paper
cycle tapes are not required.
◻ Casters are locked (if equipped).
◻ Chamber is leveled properly.
◻ Door opens and closes smoothly.
◻ Door lock switches are adjusted properly.
◻ Shelves operate properly.
◻ A leak test has been performed on the Sterilization Unit (refer to Leak Test).
◻ Items for sterilization are compatible with Sterilant (refer to Material Compatibilty).
◻ Load has been thoroughly cleaned, rinsed and dried (refer to Cleaning, Rinsing, and Drying).
◻ Only use a STERIS approved BI and Challenge Pack for use in this Sterilization Unit (refer to Biological Indicator
Challenge Pack). In the U.S., use only a FDA-cleared BI and Challenge Pack for use with this Low Temperature
Sterilization System.