INDICATIONS FOR USE
Document # M4070EN.2016-03, Rev. B
©2016 STERIS Corporation.
All rights reserved.
The V-PRO 60 Low Temperature Sterilization System, with VAPROX
®
HC Sterilant, is a vaporized hydrogen peroxide
sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable 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.
a The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two
pouches for a total weight of 11 lbs (5.0 kg).
b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs
(5.4 kg).
c The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and
no additional load.
V-PRO 60
Sterilizer Cycle
Indications for Use
Total Load
Lumen Cycle
Can sterilize
a
:
• Instruments with diffusion-restricted spaces such as the
hinged portion of forceps and scissors
• Non-lumened devices including non-lumened rigid and
semi-rigid endoscopes
• Medical devices, including single, dual and triple
channeled rigid and semi-rigid endoscopes, with the
following configurations
a
:
1. Single or dual lumen devices with stainless steel
lumens that are ≥ 0.77 mm (~1/32”) internal diameter
(ID) and ≤ 410 mm (16-9/64”) in length
2. Triple lumen devices with stainless steel lumens that are:
≥ 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
or
≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
11 lbs (5.0 kgs)
and
12 Lumens
Non Lumen Cycle
Can sterilize
b
:
• Non-lumened devices including non-lumened rigid, semi-
rigid and flexible endoscopes and non-lumened devices
with stainless steel or titanium diffusion-restricted spaces
such as the hinged portion of forceps and scissors.
12 lbs (5.4 kgs)
Flexible Cycle
Can sterilize
c
:
• One flexible surgical endoscope or bronchoscope with
a light cord (if not integral to endoscope) and mat without
any additional load. The flexible endoscope may be a:
Single or dual lumen device with lumens that are > 1 mm
(~3/64”) ID and < 990 mm (38-63/64”) in length
NA
1
Teflon is a registered trademark of the E.I. du Pont de Nemours and Company.
2
da Vinci
®
is a registered trademark of Intuitive Surgical, Inc.
