V-PRO® 1 Plus and V-PRO® maX Low Temperature

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems’ Lumen Cycle can sterilize:(a)

• Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)

o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length

o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length

o triple channeled devices with stainless steel lumens that are

≥ 1.2 mm ID and ≤ 275 mm in length

≥ 1.8 mm ID and ≤ 310 mm in length

or

≥ 2.8 mm ID and ≤ 317 mm in length

(a) The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (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 lbs.

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems’ Non Lumen Cycle can sterilize: (b)

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 areas such as the hinged portion of forceps or scissors.

(b) The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 50 lbs.

The V-PRO maX Low Temperature Sterilization System’s 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 two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. (c)

The flexible endoscopes may contain either:

• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• or two lumens with:

• one lumen that is ≥ 1 mm ID and ≤ 990 mm in length

• and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

(c) The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.(d)

The flexible endoscope can contain either:

• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• or two lumens with:

• one lumen that is ≥ 1 mm ID and ≤ 990 mm in length

• and the other lumen that is ≥ 1 mm and ≤ 850 mm in length

(d) 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 load weight of 24.0 lbs.

The parameters for the three V-PRO Cycles are as follows:

Table 1: Parameters for V-PRO Cycles

Sterilization Cycle Sterilant injection (g) # of Injections Sterilant Exposure Time (min) Chamber Pressure Prior to Injection (Torr) Chamber/Vaporizer Temperature (°C)

Lumen 2.1 4 32 0.4 50/60

Non Lumen 2.1 4 12 1 50/60

Flexible 2.1 4 12 0.4 50/60