— A Word From STERIS
5
Operator Manual
V-PRO
®
maX 2
10085896_H
devices in Healthcare Facilities. The Sterilization Cycles operate at low pressure and temperature, suitable for
processing medical devices sensitive to heat and moisture.
NOTE: Refer to Component Identification of this manual for descriptions of the Sterilization
System controls.
This Low Temperature Sterilization Unit is equipped with four pre-programmed Sterilization Cycles: the Lumen Cycle
(approximately 55 minutes to complete), the Non Lumen Cycle (approximately 28 minutes to complete), the Flexible
Cycle (approximately 35 minutes to complete), and the Fast Non Lumen Cycle (approximately 16 minutes to complete).
CAUTION
POSSIBLE EQUIPMENT DAMAGE
This Low Temperature Sterilization System should NOT be used to Sterilize liquids,
linens, powders, or cellulose materials (refer to Material Compatibility).
The Non Lumen Cycle can Sterilize
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non-lumened instruments including non-lumened general medical instruments,
non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless-steel or titanium
diffusion-restricted spaces such as the hinged portion of forceps or scissors.
The Fast Non Lumen Cycle can Sterilize
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Non-lumened instruments including non-lumened general medical
instruments, non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened instruments with stainless-steel
or titanium diffusion-restricted spaces such as the hinged portion of forceps or scissors.
The Flexible Cycle can Sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology
and Surgical Care) and bronchoscopes in either of the two configurations:
1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
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The
flexible endoscopes may contain:
• One lumen with an inside diameter of ≥ 1 mm (~3/64”) and a length of ≤ 990 mm (39”)
• And the other lumen with an inside diameter of ≥ 1 mm (~3/64”) and a length of ≤ 850 mm (33”).
2. One flexible endoscope with a light cord (if not integral to endoscope), endoscope accessories, and mat and
additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged
portion of forceps and scissors.
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The flexible endoscope may contain:
• A single lumen with an inside diameter of ≥ 1 mm (~3/64”) and a length of ≤ 1050 mm (41”)
• Or two lumens with:
– One lumen with an inside diameter of ≥ 1 mm (~3/64”) and a length of ≤ 990 mm (39”)
– And the other lumen with an inside diameter of ≥ 1 mm (~3/64”) and a length of ≤ 850 mm (33”).
7. Validation studies were conducted using validation load consisting of two instrument trays and two pouches for a total weight of 50 lb
(22.7 kg).
8. Validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lb (5 kg).
9. Validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not
integral to endoscope).
10. The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope).
Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lb (11 kg).
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