— A Word From STERIS
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10085896_H
V-PRO
®
maX 2
Operator Manual
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 single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤
1050 mm in length
2. One flexible endoscope with a light cord (if not integral to endoscope), endoscope accessories, mat and
additional instruments.
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The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID
and ≤ 1050 mm in length.
Additional instruments may include non-lumened or lumened medical devices with the following configurations:
• Single, dual, or triple channel stainless-steel lumen that are ≥ 0.48 mm ID and ≤ 100 mm in length
The Lumen Cycle can Sterilize
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medical devices with the following configurations:
1. Single, dual, or triple channeled stainless-steel lumens that are:
a. ≥ 0.77 mm ID and ≤ 527 mm in length
b. ≥ 0.8 mm ID and ≤ 542 mm in length
c. ≥ 0.48 mm ID and ≤ 100 mm in length
2. Dead end lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length
3. Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps, and trocars) that are:
a. ≥ 3 mm ID and ≤ 298 mm in length
b. ≥ 4 mm ID and ≤ 424 mm in length
The V-PRO maX 2 Low Temperature Sterilization System Users are Sterile Processing Department (SPD) operators
and/or supervisors.
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.
Clinical Benefit
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is not directly used on patients.
This Low Temperature Sterilization System using proprietary Sterilant is used to Sterilize critical and semi-critical
medical devices in Healthcare Facilities. The indirect clinical benefit of this Low Temperature Sterilization System is that
medical devices processed according to supplied instructions located in the Operator Manual can be safely used in
patient procedures without risk of infection.
Intended Use (Outside North America)
The Low Temperature Sterilization System using proprietary Sterilant is intended for use in the terminal Sterilization of
properly prepared (cleaned, rinsed and dried, refer to Cleaning, Rinsing, and Drying) metal and nonmetal medical
4. Validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not
integral to endoscope).
5. Validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral
to endoscope) and 5 stainless-steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total
weight of 24 lb (11 kg).
6. 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. The 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).
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