Steris V-PRO maX 2 User manual

10085896
Revision H
V-PRO®maX 2
Low Temperature Sterilization System
Operator Manual

— A Word From STERIS
2
10085896_H V-PRO®maX 2 Operator Manual
A Word From STERIS
Introduction
IMPORTANT: A listing of the Safety Precautions to be observed when operating and servicing this
equipment and/or handling the Sterilant can be found in Safety Precautions of this manual. Do not
operate or service the equipment or handle the Sterilant until you have been trained on this information.
Please refer to Glossary and Symbols for a list of terminology used in this document. This manual
describes device Sterilization using a proprietary Sterilant. Refer to the Sterilant label and package insert
for detailed Safety Precautions.
Thank you for choosing this fine STERIS product. STERIS is committed to ensuring your continued satisfaction. This
manual contains important information on proper use and maintenance of this Low Temperature Sterilization System.
All personnel involved in the use and maintenance of this equipment must carefully review and comply with the
Safety Precautions and instructions contained in this manual and the Sterilant Safety Data Sheet (SDS), product label
and package insert. These instructions are important to protect the health and safety of personnel operating the Low
Temperature Sterilizer and should be retained in a conveniently accessible area for quick reference.
Complete instructions for uncrating and installing this unit, as well as an equipment drawing (refer to Associated
Publications), showing all utility service and space requirements needed for proper installation of the Sterilization Unit
have been furnished separately. If missing, contact STERIS for replacement copies, giving the serial, equipment and
model numbers of the unit.
Please contact STERIS if supervision is desired for uncrating, installation, and setting up this equipment.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and
competent authority in the country where the incident occurred.
Advisory
A listing of the Safety Precautions to be observed when operating, installing, and servicing this Low Temperature
Sterilization System and/or handling the Sterilant1is found in Safety Precautions of this manual. Do not operate or
service the equipment or handle the Sterilant Cartridges (Cups) until you have become familiar with this information.
Please refer to the Sterilant package insert for additional information.
Any alteration of the Sterilization System not authorized or performed by STERIS which could affect its operation will
void the warranty, could adversely affect operator safety, could adversely affect Sterilization efficacy and could violate
national, state, or local regulations.
Waste Products Disposal
The following are waste materials associated with the Sterilization Unit. When disposing of waste materials, ensure
disposal is in compliance with federal, state and local regulations.
• Printer paper – Recyclable.
• Printer ribbon (if equipped) – Not recyclable.
• Consumables – Dispose in a safe manner in accordance with local/national regulations and current Safety Data
Sheets (SDS).
• Consumables containers – Empty containers should be cleaned in accordance with local/national regulations and
current Safety Data Sheets (SDS). Empty containers should be taken for recycling, recovery or waste according to
applicable regulation.
1. Sterilant Cartridge (Cup) is not packed with the sterilization system.

— A Word From STERIS
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Operator Manual V-PRO®maX 2 10085896_H
• Entire Sterilizer (end-of-life) – Contact STERIS Corporation for disposal or recycling recommendations.
• Oil from vacuum pump – Recyclable.
Intended Use (North America)
This 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) medical devices in Healthcare
Facilities. The preprogrammed Sterilization Cycles operate at low pressure and temperature, suitable for processing
medical devices without leaving toxic residues.
NOTE:
Refer to Main Sterilization Unit and Cycle Controls of this manual for descriptions of the Sterilization System controls.
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
This Low Temperature Sterilization System should NOT be used to Sterilize liquids, linens, powders, or
cellulose materials (refer to Material Compatibility).
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.
Each Cycle can Sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of
forceps and scissors.
The Non Lumen Cycle can Sterilize2non-lumened instruments including non-lumened general medical instruments,
non-lumened rigid, semi-rigid and flexible endoscopes.
The Fast Non Lumen Cycle can Sterilize3non-lumened instruments including non-lumened general medical
instruments, non-lumened rigid, semi-rigid, and flexible endoscopes.
2. Validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lb (22. 7 kg).
3. Validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lb (5 kg).

— 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.4The
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.5The 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 Sterilize6medical 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).

— A Word From STERIS
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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 Sterilize7non-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 Sterilize8Non-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.9The
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.10 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).

— A Word From STERIS
6
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 Sterilize11 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®12 tubing13 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.

— A Word From STERIS
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Operator Manual V-PRO®maX 2 10085896_H
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.
Service Information
A thorough preventive maintenance program is essential to safe and proper equipment operation. Comprehensive
instructions for preventive maintenance can be found in the Maintenance Manual (available from STERIS).
Only STERIS-trained personnel should attempt to perform maintenance on this Low Temperature Sterilization System
Components to avoid personal injury, improper equipment performance, invalidation of the warranty or other costly
damage.
Customers are encouraged to contact STERIS concerning our annual maintenance program. Under the terms of the
program, preventive maintenance, adjustments and replacement of worn parts are provided on a scheduled basis to
help ensure optimal equipment performance and to help minimize untimely or costly interruptions. STERIS maintains a
worldwide staff of well-equipped, factory-trained technicians to provide these services, as well as on-site installation,
training and expert repair services. Contact STERIS for details.
IMPORTANT: Insufficient clearance space makes repairs more difficult and time-consuming. Refer to the
equipment drawing for minimum clearance for service/maintenance access requirements.
Associated Publications
Publications listed in this section are those associated with the use and maintenance of this Low Temperature
Sterilization System.
When ordering, please include the part number (if applicable), description and quantity of each publication requested.
Order directly from STERIS.
Table -1. Associated Publications
Description Part Number
Tech Data Sheet 10261907 (SD1047)
Uncrating Instructions 10085696
Installation Instructions 10085694
Operator Manual 10085896
Maintenance Manual P764336895

— A Word From STERIS
8
10085896_H V-PRO®maX 2 Operator Manual
Addresses
iv
P129385-215 Operator Manual Introduction
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 USA
440-354-2600 • 800-444-9009
EC Authorized Representative
STERIS Ltd.
STERIS House
Jays Close
Viables
Basingstoke
Hampshire
RG22 4AX
UNITED KINGDOM
STERIS Corporation,
Erie, Pennsylvania is an
ISO 13485 certified facility.
The base language of this document is
ENGLISH. Any translations must be made
from the base language document.
2797
2-2
Part Number Manual Type Chapter Name
DRAFT
.
STERIS Ireland Limited
IDA Business and Technology Park
Tullamore
County Offaly
R35 X865 Ireland
Manufactured by:
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060–1834 USA
440–354–2600 ●800–444–9009
www.steris.com
ii
150832-321 Operator Manual Introduction
Distributed by:
STERIS Corporation
2720 Gunter Park East
Montgomery, AL 36109 • USA
TEL: [phone]
FAX: [phone]
www.steris.com
Class 1 Equipment
Type B Equipment
Medical Device
Unique Device Identifier
.

9
Operator Manual V-PRO®maX 2 10085896_H
TABLE OF CONTENTS
Section Number Description Page
1 Safety Precautions ........................................................................................................................................ 1
1.1 Introduction................................................................................................................................. 1
1.2 DANGER — Slipping Hazard...................................................................................................... 2
1.3 DANGER — Fire And Explosion Hazard.................................................................................... 2
1.4 DANGER — Personal Injury, Contaminated Load and/or Equipment Damage ..................... 3
1.5 DANGER — Chemical Injury Hazard ......................................................................................... 3
1.6 WARNING — Personal Injury And/Or Equipment Damage Hazard........................................ 4
1.7 WARNING — Biohazard Control ............................................................................................... 5
1.8 WARNING — Electric Shock Hazard ......................................................................................... 5
1.9 WARNING — Aborted Cycle Hazard ......................................................................................... 5
1.10 WARNING — Slipping Hazard ................................................................................................... 6
1.11 CAUTION — Possible Equipment Damage............................................................................... 6
2 Glossary and Symbols................................................................................................................................... 8
2.1 Glossary....................................................................................................................................... 8
2.2 Hydrogen Peroxide Sterilization ................................................................................................ 9
2.3 Symbols..................................................................................................................................... 12
3 Installation Verification .............................................................................................................................. 15
3.1 Introduction............................................................................................................................... 15
3.2 Installation Checklist ................................................................................................................ 15
3.3 Technical Specifications ........................................................................................................... 17
4 Hydrogen Peroxide Handling ..................................................................................................................... 20
4.1 Hydrogen Peroxide Handling Precautions .............................................................................. 20
4.2 Sterilant Cup Installation And Removal .................................................................................. 21
5 Component Identification ........................................................................................................................... 26
5.1 General ...................................................................................................................................... 26
5.2 Main Sterilization Unit and Cycle Controls..............................................................................26
5.3 Control Displays (Touch Screens) ............................................................................................ 28
5.4 Alarm Screens ........................................................................................................................... 29
5.5 Thermal Printer......................................................................................................................... 31
5.6 Printouts.................................................................................................................................... 31
6 Operation ...................................................................................................................................................... 32
6.1 Introduction............................................................................................................................... 32
6.2 Advisory..................................................................................................................................... 32
6.3 Preliminary Information ........................................................................................................... 32
6.4 Before Operating Sterilization Unit ......................................................................................... 33
6.5 Load Sterilization Unit .............................................................................................................. 35
6.6 VHP Sterilization Cycle Operation ........................................................................................... 37
7 Troubleshooting........................................................................................................................................... 49
7.1 Introduction............................................................................................................................... 49
7.2 Typical Alarm Screen ................................................................................................................ 50
7.3 Typical Alarm Printout.............................................................................................................. 51
7.4 Alarm Types .............................................................................................................................. 52
7.5 Air Utility Failure — ALM ......................................................................................................... 53
7.6 Biological Indicator Issue — NonALM .................................................................................... 53

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10085896_H V-PRO®maX 2 Operator Manual
7.7 Chamber Overtemp — ALM .................................................................................................... 54
7.8 Chamber Pressure Deviation — ALM ..................................................................................... 54
7.9 Chamber Temp Deviation — ALM .......................................................................................... 54
7.10 Chamber Undertemp — ALM.................................................................................................. 55
7.11 Chemical Indicator Issue — NonALM ..................................................................................... 55
7.12 Control Data CRC Error — ALM............................................................................................... 56
7.13 Cup Empty — ALM................................................................................................................... 56
7.14 Cup Expired — ALM ................................................................................................................. 56
7.15 Cup Invalid................................................................................................................................. 57
7.16 Cup Read Error — ALM............................................................................................................ 57
7.17 Cup Receiver Door Works Improperly — NonALM ................................................................ 57
7.18 Cup Receiver Open — ALM ..................................................................................................... 58
7.19 Date/Time Problem — NonALM ............................................................................................. 58
7.20 Display Not Working — NonALM............................................................................................ 58
7.21 Door Issue — NonALM ............................................................................................................ 59
7.22 Door Open — ALM ................................................................................................................... 59
7.23 Door Open Too Long — ALM .................................................................................................. 59
7.24 Door Unlocked — ALM ............................................................................................................ 60
7.25 Draw Tube Switch Failure — ALM .......................................................................................... 60
7.26 Failure Reading PT1 — ALM ................................................................................................... 60
7.27 Failure Reading PT2 — ALM ................................................................................................... 61
7.28 Failure Reading RTD1 — ALM................................................................................................. 61
7.29 Failure Reading RTD2 — ALM................................................................................................. 61
7.30 Failure Reading RTD3 — ALM................................................................................................. 61
7.31 Failure Reading RTD4 — ALM................................................................................................. 62
7.32 File Write Error — ALM ........................................................................................................... 62
7.33 Injection Limit Reached ............................................................................................................ 62
7.34 Inject Switch Failure — ALM ................................................................................................... 63
7.35 I/O Board Communication Failure — ALM............................................................................. 63
7.36 Leak Test Failure — ALM ........................................................................................................ 63
7.37 Load Too Wet — ALM.............................................................................................................. 64
7.38 LS10 Switch Failure — ALM.................................................................................................... 64
7.39 LS11 Switch Failure — ALM.................................................................................................... 65
7.40 LS12 Switch Failure — ALM.................................................................................................... 65
7.41 Memory Read Error — ALM.................................................................................................... 65
7.42 Memory Write Error — ALM ................................................................................................... 66
7.43 No Power — NonALM ............................................................................................................. 66
7.44 Odor or Oil Misting from Unit — NonALM ............................................................................. 66
7.45 Oil Leak — NonALM................................................................................................................. 66
7.46 Power Failure — ALM.............................................................................................................. 67
7.47 Pressure Rise High — ALM ..................................................................................................... 67
7.48 Pressure Rise Low — ALM...................................................................................................... 68
7.49 Printer Does Not Print — NonALM.........................................................................................68
7.50 Printer Failure — ALM ............................................................................................................. 69
7.51 Real Time Clock Failure — ALM .............................................................................................. 69
7.52 Reservoir Overfill — ALM ........................................................................................................ 70
7.53 Scanner Failure ......................................................................................................................... 70
7.54 Software Reboot....................................................................................................................... 70
7.55 Too Long to Air Break — ALM................................................................................................. 71

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Operator Manual V-PRO®maX 2 10085896_H
7.56 Too Long to Charge (Air Compressor) — ALM ....................................................................... 71
7.57 Too Long to Evacuate — ALM................................................................................................. 72
7.58 Too Long to Extend Tube — ALM ........................................................................................... 73
7.59 Too Long To Fill (Reservoir) — ALM ....................................................................................... 73
7.60 Too Long to Heat Chamber — ALM........................................................................................ 74
7.61 Too Long to Heat Vapor — ALM ............................................................................................. 74
7.62 Too Long to Inject — ALM....................................................................................................... 75
7.63 Too Long to Inject Fill — ALM ................................................................................................. 75
7.64 Too Long to Lock Door — ALM ............................................................................................... 76
7.65 Too Long to Retract Tube — ALM .......................................................................................... 76
7.66 Too Long to Unlock Door — ALM ........................................................................................... 76
7.67 Unit Does Not Alarm When Cup Is Empty — NonALM ......................................................... 77
7.68 Unit Not Calibrated — ALM..................................................................................................... 77
7.69 Vaporizer Overtemp — ALM ................................................................................................... 77
7.70 Vaporizer Temp Deviation — ALM.......................................................................................... 78
7.71 Vaporizer Undertemp — ALM ................................................................................................. 78
8 Routine Maintenance .................................................................................................................................. 79
8.1 Introduction............................................................................................................................... 79
8.2 Read Before Performing Routine Maintenance ..................................................................... 79
8.3 Routine Operator Maintenance ............................................................................................... 80
8.4 Cleaning Sterilization System .................................................................................................. 80
8.5 Leak Test ................................................................................................................................... 83
8.6 Change Printer Paper Roll ........................................................................................................ 85
8.7 Preventive Maintenance Schedule .......................................................................................... 87
8.8 Vacuum Pump Maintenance Indicator .................................................................................... 88
8.9 Replacement Parts ................................................................................................................... 89
9 Printouts....................................................................................................................................................... 91
10 Appendix A..................................................................................................................................................100
10.1 Cleaning, Rinsing and Drying .................................................................................................100
10.2 Packaging and Loading...........................................................................................................101
11 Appendix B (Supervisor Screens).............................................................................................................108
12 Appendix C..................................................................................................................................................114

1 — Safety Precautions
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10085896_H V-PRO®maX 2 Operator Manual
Safety Precautions
1.1 Introduction
The following Safety Precautions must be observed when operating or servicing this Low Temperature Sterilization
System and when handling the Sterilant Cartridges (Cups). Safety Precautions are divided as follows:
• DANGER indicates personal injury or substantial property damage results if proper precautions are not taken.
• WARNING indicates the potential for personal injury and/or potential for property damage may result if proper
precautions are not taken.
• CAUTION indicates the potential for damage to equipment may result if proper precautions are not taken.
For emphasis, certain Safety Precautions are repeated throughout the manual. It is important to review ALL Safety
Precautions before operating or servicing the Unit.
Strictly following these Safety Precautions enhances the Customer’s ability to safely and
effectively use the equipment and helps avoid improper maintenance methods which may damage the unit or render it
unsafe. It is important to understand that these Safety Precautions are not exhaustive; Customers are encouraged to
develop their own safety policies and procedures to enhance and complement these Safety Precautions.
Important: Please read the Operator Manual (refer to Associated Publications) to get the best understanding and to
help ensure best performance of this equipment, which has been thoroughly inspected, tested and adjusted by factory-
trained personnel.
Equipment maintenance other than described in the manual (unless by authorized representatives of the STERIS
Corporation), shall be at the risk of invalidating the equipment warranty.
Hydrogen Peroxide Handling Precautions
Certain precautions must be observed when handling the Sterilant. Review the Safety Precautions located in this
Section of the manual before handling the Sterilant Cups. Also, read, comply with, and save the Sterilant Safety Data
Sheet (SDS). If misplaced, please contact STERIS for replacement.
STERIS recommends that all operators should be regularly trained in the operation and safe usage of the equipment,
including emergency procedures for any harmful material released into the environment. Records of attendance at
training shall be maintained and evidence of understanding shall be demonstrated.
Important: This equipment is designed to minimize operator potential contact with the Sterilant. The Sterilant Cup is
designed to prevent accidental spillage and the equipment is designed to ensure the Sterilant Cup cannot be removed
unless it is empty.
The SDS is available at www.steris.com .

1 — Safety Precautions
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Operator Manual V-PRO®maX 2 10085896_H
1.2 DANGER — Slipping Hazard
DANGER
SLIPPING HAZARD
Water or hydrogen peroxide spilled on the floor presents a slipping hazard – promptly
clean up the spill. If in doubt as to whether the liquid is water or hydrogen peroxide,
assume spill is hydrogen peroxide. Put on appropriate Personal Protective Equipment
(PPE; refer to Glossary), contain the spill and dilute with water (at least 20 parts water
to one part H2O2) prior to wiping up. Observe all hydrogen peroxide handling
precautions. Refer to the Sterilant Safety Data Sheet (SDS) for spill containment and
cleanup.
1.3 DANGER — Fire And Explosion Hazard
DANGER
FIRE AND EXPLOSION HAZARD
Liquid hydrogen peroxide is a strong oxidant and poses a FIRE, EXPLOSION OR
CONTAINER RUPTURE HAZARD. Avoid excessive heat, contamination or contact with
combustible materials. Clothing, shoes or other combustible materials that have come
in contact with hydrogen peroxide must be immediately and thoroughly washed with
water. Discard shoes contaminated with Sterilant in a fireproof container. If Sterilant is
allowed to dry in the materials, a fire may result. IN CASE OF FIRE, use water only.
CONTAIN SPILLS and dilute with 20 parts water. SEE SAFETY DATA SHEET (SDS) FOR
ADDITIONAL INFORMATION. EFFECTS MAY BE DELAYED AND A FIRE COULD START AT
A LATER TIME.
Verify all materials coming in contact with hydrogen peroxide are compatible with
oxidizers. Contact STERIS or the material manufacturer for information on material
compatibility.
This Sterilization Unit is not designed to process flammable liquids. Do not process
liquids, linens, powders or any cellulose materials. Process only those materials
compatible with hydrogen peroxide.

1 — Safety Precautions
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10085896_H V-PRO®maX 2 Operator Manual
1.4 DANGER — Personal Injury, Contaminated Load and/or Equipment Damage
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND / OR EQUIPMENT DAMAGE HAZARD
Use only Sterilant Cups which have been specially formulated, tested and approved for
use in this Sterilization System. Use of other sterilants could impair equipment
operation, result in costly repairs, result in an ineffective Sterilization Cycle and void the
equipment warranty.
Failure to thoroughly clean, rinse and dry articles to be Sterilized could result in an
ineffective Sterilization Cycle.
Failure to follow the V-PRO Sterilization Tray or the V-PRO Instrument Organizers
operating instructions could result in an ineffective Sterilization Cycle.
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.
1.5 DANGER — Chemical Injury Hazard
DANGER
CHEMICAL INJURY HAZARD
Any visible liquids in the chamber or on the load must be treated as concentrated
hydrogen peroxide. Observe all hydrogen peroxide handling precautions. Refer to the
Sterilant Safety Data Sheet (SDS) for appropriate Personal Protective Equipment (PPE;
refer to Glossary), spill containment and cleanup.
When handling hydrogen peroxide, wear appropriate Personal Protective Equipment
(PPE; refer to Glossary) and observe all Safety Precautions. See Sterilant SDS, product
label and package insert for additional handling information.
CORROSIVE. Causes irreversible eye damage or skin burns. Harmful if swallowed or
absorbed through the skin. Do not get in eyes, on skin or on clothing. User should wash
hands before eating, drinking, chewing gum, using tobacco or using the toilet. User
should remove contaminated clothing and wash before reuse. See Sterilant product
label and package insert for additional handling information.

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Operator Manual V-PRO®maX 2 10085896_H
1.6 WARNING — Personal Injury And/Or Equipment Damage Hazard
WARNING
PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD
Repairs and adjustments to this equipment must be made only by STERIS or STERIS-
trained service personnel. Maintenance performed by unqualified personnel or
installation of unauthorized parts could cause personal injury, result in improper
equipment performance, invalidate the warranty or result in costly damage. Contact
STERIS regarding service options.
Regularly scheduled preventive maintenance is required for safe and reliable operation
of this equipment. Contact STERIS to schedule preventive maintenance.
When closing the chamber door, keep hands and arms out of the door opening and
ensure opening is clear of any obstructions.
Performance of this 510(k) cleared equipment is validated as a system including
components defined by STERIS in the Operator Manual and Service Manual for this
Sterilization Unit. Substitution of unauthorized components can potentially lead to
personal injury, damage or premature failure of the product and result in a Unit
configuration that is inconsistent with the validated, FDA cleared product. The STERIS
warranty is void if components are used that are not approved. DO NOT USE
components that are not validated as part of this equipment.
Lifting or moving the Sterilization System requires more than one person. Note Unit
weight (refer to Installation Checklist in Operator Manual). Move/position Unit only on
flat surfaces.
Wear Personal Protective Equipment (PPE; refer to Glossary) when changing the
vacuum pump oil.

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10085896_H V-PRO®maX 2 Operator Manual
1.7 WARNING — Biohazard Control
WARNING
BIOHAZARD CONTROL
Do not attempt to use steam or EO biological/chemical indicators in this Sterilization
Unit or ineffective Sterilization Cycle may not be detected.
Use only BIs, CIs, BI Challenge Packs and other system accessories recommended by
STERIS as these items have been validated to assure proper functioning with the Low
Temperature Sterilization System. Ineffective Sterilization Cycle may not be detected
using other system accessories.
1.8 WARNING — Electric Shock Hazard
WARNING
ELECTRIC SHOCK HAZARD
Disconnect equipment from facility electrical supply before servicing. Do not service this
equipment unless electrical service has been locked out. Always follow appropriate
Lockout-Tagout and electrical safety-related work practice standards.
Always use STERIS provided wire with minimum rating of 149 °F (65 °C).
1.9 WARNING — Aborted Cycle Hazard
WARNING
ABORTED CYCLE HAZARD
A leak test is recommended to be performed monthly on the Sterilization Unit to ensure
chamber leak rate is within specification. The leak rate must be less than 0.3
Torr/minute (0.4 mbar/minute or 0.04 kPa/minute). If not, an abort results, door
remains locked and Sterilization Unit service is required.

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Operator Manual V-PRO®maX 2 10085896_H
1.10 WARNING — Slipping Hazard
WARNING
PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD
Changing vacuum pump oil could present a slipping hazard – promptly clean floor
around unit. Wear Personal Protective Equipment (PPE; refer to Glossary) when
cleaning floor of any vacuum pump oil.
1.11 CAUTION — Possible Equipment Damage
CAUTION
POSSIBLE EQUIPMENT DAMAGE
Use nonabrasive cleaners when cleaning the unit. Follow directions on the container.
For stainless steel, rub in a back-and-forth motion (in the same direction as the surface
grain). Abrasive cleaners damage stainless steel and aluminum. Cleaner rubbed in a
circular motion or applied with a wire brush or steel wool can be harmful to stainless
steel and aluminum. Do not use abrasive cleaners on painted and plastic surfaces.
Never use a wire brush, abrasives or steel wool on inside of chamber door and chamber
assembly.
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 manufacturer's instructions.
●All water resistant or immersion caps used in any cleaning procedures MUST BE
removed prior to Sterilization.
Do not operate vacuum pump motor (M1) longer than needed to verify rotation or pump
damage might occur. Allow pump to warm before using.
The door closed switch must be adjusted for minimum protrusion past the end frame. If
the switch protrudes too far, the door will touch the threaded part of the switch. This
would cause the door to be held off of the door gasket and result in a leak.

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10085896_H V-PRO®maX 2 Operator Manual
This Low Temperature Sterilization System should NOT be used to Sterilize liquids,
linens, powders, or cellulose materials (refer to Material Compatibility). The Non Lumen
and Fast Non Lumen (if equipped) Cycles should NOT be used to Sterilize non-stainless
steel or non-titanium mated surfaces (refer to Material Compatibility).
IMPORTANT:
Insufficient clearance space makes repairs more difficult and time-consuming. Refer to the equipment drawing for minimum
clearance for service/maintenance access requirements.

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Operator Manual V-PRO®maX 2 10085896_H
Glossary and Symbols
2.1 Glossary
Aeration – Final phase of Sterilization Cycles. Allows for removal of load once the VHP Sterilant levels are at or below
permissible levels.
BI – Biological Indicator.
Cartridge –VAPROX®HC Sterilant Cartridge; also referred to as a Cup.
Catalytic Converter – A component of the VHP®Sterilization Unit utilizing a catalyst to degrade H2O2into water vapor
and oxygen.
CI – Chemical Indicator.
Condition – First phase of Sterilization Cycles. Moisture is removed from the load and a moisture check is performed.
Cup – VAPROX HC Sterilant Cartridge.
HEPA – High Efficiency Particulate Air filter.
HMI – Human Machine Interface (such as the control display).
H2O2 or H2O2–Hydrogen peroxide.
ID – Inside Diameter.
I/O – Input/Output.
Lumen – Hollow channel in a medical device that allows the passage of accessories, air or water from the medical
device control head, through the channel, and into the surgical field of view. For surgical guides and anatomical models,
the lumen definition applies to any tubular, hollow channel that a medical device may be passed through. For surgical
guides, this includes penetrations that drill bits, pins or screws will pass through.
Mated Surface – A diffusion-restricted space on an instrument such as the hinged portion of forceps and scissors.
NC – Normally Closed.
NO – Normally Open.
NOE – Non-Operating End.
OE –Operating End.
PPE – Personal Protective Equipment. STERIS recommends wearing chemical resistant gloves when handling Sterilant
Cup or unloading Sterilization Unit.
SDS – Safety Data Sheet.
Sterilant –(VAPROX HC) – Proprietary STERIS 59% Hydrogen Peroxide Sterilant supplied in Cartridges. VAPROX HC
Sterilant also contains stabilizers making it suitable for STERIS Sterilization Units.
Sterilize – Either the second phase of the Sterilization Cycles or Sterilization of the load. Sterilization of a load occurs
through use of an antimicrobial product to destroy microbes. The VHP antimicrobial at the target concentration is
added in a series of pulses for a specified period of time to achieve Sterilization.
Sterilization – Complete killing of all microbial life including spores.
Sterilization Cycles – Lumen, Non Lumen, Fast Non Lumen, and Flexible.
Users — Sterile Processing Department (SPD) operators and/or supervisors.
Sterilization Unit – V-PRO®maX 2 Low Temperature Sterilization System.
VAPROX HC Sterilant – Proprietary STERIS 59% Hydrogen Peroxide Sterilant supplied in Cartridges. VAPROX HC
Sterilant also contains stabilizers making it suitable for STERIS Sterilization Units.

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10085896_H V-PRO®maX 2 Operator Manual
Vac – Volts Alternating Current.
Vdc – Volts Direct Current.
VHP – STERIS proprietary technology utilizing Vaporized Hydrogen Peroxide.
2.2 Hydrogen Peroxide Sterilization
Introduction
This Low Temperature Sterilization System utilizes STERIS VHP®Technology to provide a rapid, low-temperature,
simple and reliable method for Sterilization of metal and nonmetal devices in Healthcare Facilities.
This section includes the following:
The Sterilization Process
The Sterilization Cycles
The Catalytic Converter
Cup Level Indicator
The Sterilization Process
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND/OR EQUIPMENT DAMAGE HAZARD
●Use only Sterilant Cups which have been specially formulated, tested and approved
for use in this Sterilization System. Use of other Sterilants could impair equipment
operation, result in costly repairs, result in an ineffective Sterilization Cycle and void
the equipment warranty.
●Failure to thoroughly clean, rinse and dry articles to be Sterilized could result in an
ineffective Sterilization Cycle.
This Low Temperature Sterilization Unit uses a deep vacuum to deliver Sterilant vapor to all exposed surfaces inside the
chamber. Because Sterilization relies only on the contact of Sterilant with exposed surfaces, the transfer of heat and
moisture required by steam processes is not necessary.
Sterilant vapor is injected by volume, over a series of programmed pulses, to assure Sterilization. Once the Sterilant
vapor leaves the chamber, it is catalytically converted into harmless and environmentally friendly water vapor and
oxygen.
For Sterilization, note the following:
• Prior to Sterilization, all materials and articles must be thoroughly cleaned, rinsed and dried.
• After Sterilization, goods should be stored in conditions that do not compromise the sterility barrier.
• For Sterilization of articles or materials not covered in this manual, contact the manufacturer of the article for
recommended procedure.