— A Word From STERIS
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10085896_H
V-PRO
®
maX 2
Operator Manual
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND/OR EQUIPMENT DAMAGE HAZARD
Processing a load containing a stainless-steel lumened instrument through the Non
Lumen or Fast Non Lumen (if equipped) Cycle results in an ineffective Sterilization Cycle.
Do not process stainless-steel lumened devices in a Non Lumen or Fast Non Lumen
Cycle.
CAUTION
POSSIBLE EQUIPMENT DAMAGE
Flexible endoscope damage may occur from the vacuum produced inside Sterilization
Unit chamber from inability to vent air normally present inside endoscope unless:
● If flexible endoscope is equipped with Ethylene Oxide (EO) or Venting Cap, these caps
MUST BE used per manufacture’s instructions.
● All water resistant or immersion caps used in any cleaning procedures MUST BE
removed prior to Sterilization.
The Lumen Cycle can Sterilize
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the following:
1. Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following
configurations:
• Single channeled devices with a stainless lumen that is ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 500
mm (19- 11/16”) in length
• Dual channeled devices with stainless lumens that are ≥ 0.77 mm (~1/32”) ID and ≤ 527 mm (20-3/4”) in
length
• Triple channeled devices with stainless lumens that are either:
– ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-55/64”) in length
– ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length
– ≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
NOTE: Single-Use, medical grade polyethylene (PE) and Teflon®
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tubing
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with internal diameter ≥
1 mm and length ≤ 4 m may be sterilized in the Flexible Cycle. Up to 26 pieces of tubing with no
additional load may be sterilized.
Uses other than those specified and described in these instructions are not recommended, may not result in effective
Sterilization and may cause injuries or property damage. Consult STERIS for further information.
The system utilizes specially designed disposable Cartridges (Cups), available separately, containing proprietary
Sterilant.
STERIS maintains a complete line of accessories for this Sterilization system to simplify, organize and assure sterility of
the Sterilization process. A STERIS representative will gladly review these with you.
11. Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the
maximum number of lumens validated by this testing. Validation studies were performed using a validation load consisting of two
instrument trays and two pouches for a total weight of 19.65 lb (8.9 kg).
12. Teflon is a registered trademark of E. I. duPont de Nemours and Company.
13. Tubing claims have not been reviewed by the US FDA.
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