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10099300
Revision C
V-PRO®s2
Low Temperature Sterilization System
Operator Manual
ii
10099300_C V-PRO®s2 Operator Manual
© 2023 STERIS. All rights reserved.
Published: 2023-4-26
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Operator Manual V-PRO®s2 10099300_C
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.
Intended Use
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND/OR EQUIPMENT DAMAGE HAZARD
Processing a load containing a stainless-steel lumened instrument through the Non
Lumen Cycle results in an ineffective Sterilization Cycle. Do not process stainless-steel
lumened devices in a Non Lumen Cycle.
1. Sterilant Cartridge (Cup) is not packed with the sterilization system.
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10099300_C V-PRO®s2 Operator Manual
CAUTION
POSSIBLE EQUIPMENT DAMAGE
The 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 the chamber
from inability to vent air normally present inside the endoscope unless:
●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.
This Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal Sterilization
of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed
Sterilization Cycles operate at low pressure and temperature, suitable for processing medical devices without leaving
toxic residues.
Each Cycle can Sterilize non-lumened instruments and 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 Cycle can Sterilize3medical devices (including single, dual and triple channeled rigid and semi-rigid
endoscopes) with the following configurations:
• Single or dual channeled devices with stainless-steel lumens that are:
≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length
≥ 1.8 mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length
• Triple channeled devices with stainless-steel lumens that are either:
≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and
flexible endoscopes.
The Flexible Cycle can Sterilize4one surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care)
or bronchoscope with a light cord (if not integral to endoscope), mat, and additional load:
• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in
length
2. Validation studies were conducted using validation load consisting of one instrument tray for a total weight of 25 lb (11.3 kg).
3. Validation testing for all lumen sizes was conducted using a maximum of 8 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 one
pouched instrument tray and two pouched devices outside tray for a total weight of 4.0 lb (1.8 kg).
4. Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope
with silicone mat, instrument organizers and light cord (if not integral to endoscope) and second tray contained additional load of 12
stainless-steel lumens for a total weight of 11 lb (5 kg). Hospital loads should not exceed the maximum number of lumens validated by
this testing.
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Operator Manual V-PRO®s2 10099300_C
• Additional load, up to 11 lb (5 kg) of total load, can be stainless-steel lumens with following dimensions:
≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length
≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length.
≥ 1.8 mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length
The Lumen Cycle can Sterilize5medical devices (including single, dual and triple channeled rigid and semi-rigid
endoscopes) with the following configurations:
• Single or dual channeled devices with stainless-steel lumens that are:
≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length
≥ 1.8 mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length
• Triple channeled devices with stainless-steel lumens that are either:
≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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
The V-PRO s2 Low Temperature Sterilization System Users are Sterile Processing Department (SPD) operators and/or
supervisors.
This Sterilization Unit is specifically designed to process goods using only the cycles presented in the Operator Manual.
Consult medical device’s instructions for use regarding sterilization compatibility before sterilizing in this Low
Temperature Sterilization System.
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 s2 Low Temperature Sterilization System and VAPROX HC Sterilant are not directly used on patients. The
System is used for the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in
Healthcare Facilities. The clinical benefit is that the V-PRO Sterilizer provides a sterilization process with appropriate
microbicidal activity intended to sterilize medical devices. The sterilization process is both reliable and reproducible so
that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable
microorganism present on a medical device after sterilization.
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).
5. Validation testing for all lumen sizes was conducted using a maximum of 12 stainless-steel 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 one instrument tray and two pouches for a total weight of 11 lb (5 kg).
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10099300_C V-PRO®s2 Operator Manual
• 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.
• Entire Sterilizer (end-of-life) – Contact STERIS Corporation for disposal or recycling recommendations.
• Oil from vacuum pump – Recyclable.
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.
Description Part Number
Tech Data Sheet 10660555
Uncrating Instructions 11005152
Installation Instructions 10099299
Operator Manual 10099300
Maintenance Manual P764337438
Equipment Drawing (Single Door, Cabinet) 11004441
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.
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Operator Manual V-PRO®s2 10099300_C
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
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10099300_C V-PRO®s2 Operator Manual
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 Hazard .............................................................................................................. 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 CAUTION — Possible Equipment Damage................................................................... 6
2 Glossary and Symbols....................................................................................................................... 7
2.1 Glossary........................................................................................................................... 7
2.2 Hydrogen Peroxide Sterilization ................................................................................... 8
2.3 Symbols......................................................................................................................... 11
3 Installation Verification ..................................................................................................................14
3.1 Introduction................................................................................................................... 14
3.2 Installation Checklist .................................................................................................... 14
3.3 Technical Specifications ............................................................................................... 16
4 Hydrogen Peroxide Handling .........................................................................................................18
4.1 Hydrogen Peroxide Handling Precautions .................................................................. 18
4.2 Sterilant Cup Installation And Removal ...................................................................... 19
5 Component Identification ...............................................................................................................23
5.1 General .......................................................................................................................... 23
5.2 Main Sterilization Unit and Cycle Controls.................................................................. 23
5.3 Control Displays (Touch Screens) ................................................................................ 25
5.4 Alarm Screens ............................................................................................................... 27
5.5 Thermal Printer............................................................................................................. 28
5.6 Printouts........................................................................................................................ 28
6 Operating Instructions .................................................................................................................... 30
6.1 Introduction................................................................................................................... 30
6.2 Advisory......................................................................................................................... 30
6.3 Preliminary Information ............................................................................................... 30
6.4 Before Operating Sterilization Unit ............................................................................. 31
6.5 Load Sterilization Unit .................................................................................................. 33
6.6 VHP Sterilization Cycle Operation ............................................................................... 35
7 Troubleshooting...............................................................................................................................48
7.1 Introduction................................................................................................................... 48
7.2 Typical Alarm Screen .................................................................................................... 49
7.3 Typical Alarm Printout.................................................................................................. 49
7.4 Alarm Types .................................................................................................................. 49
7.5 Biological Indicator Issue — NonALM ........................................................................ 50
7.6 Cabinet Overtemp — ALM........................................................................................... 51
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Operator Manual V-PRO®s2 10099300_C
7.7 Cabinet Temp Deviation — ALM................................................................................. 51
7.8 Chamber Overtemp — ALM ........................................................................................ 51
7.9 Chamber Pressure Deviation — ALM......................................................................... 52
7.10 Chamber Temp Deviation — ALM .............................................................................. 52
7.11 Chamber Undertemp — ALM...................................................................................... 52
7.12 Control Data CRC Error — ALM................................................................................... 53
7.13 Cup Empty — ALM....................................................................................................... 53
7.14 Cup Expired — ALM ..................................................................................................... 53
7.15 Cup Read Error — ALM................................................................................................ 54
7.16 Cup Receiver Open — ALM ......................................................................................... 54
7.17 Door Open — ALM ....................................................................................................... 54
7.18 Door Open Too Long — ALM ...................................................................................... 55
7.19 Door Unlocked — ALM ................................................................................................ 55
7.20 Draw Tube Switch Failure — ALM.............................................................................. 55
7.21 Excess Cabinet Airflow — ALM................................................................................... 55
7.22 Failure Reading PT1 — ALM ....................................................................................... 56
7.23 Failure Reading PT2 — ALM ....................................................................................... 56
7.24 Failure Reading RTD1 — ALM..................................................................................... 56
7.25 Failure Reading RTD2................................................................................................... 56
7.26 Failure Reading RTD3 — ALM..................................................................................... 57
7.27 Failure Reading RTD4 — ALM..................................................................................... 57
7.28 Failure Reading RTD5 — ALM..................................................................................... 57
7.29 Failure Reading RTD6 — ALM..................................................................................... 57
7.30 File Write Error — ALM ............................................................................................... 58
7.31 Foot Sensor Obstruction — ALM................................................................................ 58
7.32 Injection Limit Reached — ALM.................................................................................. 58
7.33 Inject Switch Failure — ALM ....................................................................................... 59
7.34 I/O Board Communication Failure — ALM ................................................................. 59
7.35 Leak Test Failure — ALM ............................................................................................ 59
7.36 Load Test Repeat — nonALM ..................................................................................... 59
7.37 Load Too Wet — ALM.................................................................................................. 60
7.38 LS10 Switch Failure — ALM........................................................................................ 60
7.39 LS11 Switch Failure — ALM........................................................................................ 60
7.40 LS12 Switch Failure — ALM........................................................................................ 61
7.41 Memory Read Error — ALM........................................................................................ 61
7.42 Memory Write Error — ALM ....................................................................................... 61
7.43 Power Failure — ALM.................................................................................................. 62
7.44 Pressure Rise High — ALM ......................................................................................... 62
7.45 Pressure Rise Low — ALM.......................................................................................... 63
7.46 Printer Failure — ALM ................................................................................................. 63
7.47 Pump Start Failure — ALM ......................................................................................... 64
7.48 Real Time Clock Failure — ALM .................................................................................. 64
7.49 Reduced Cabinet Airflow — ALM................................................................................ 64
7.50 Reservoir Overfill — ALM ............................................................................................ 65
7.51 Scanner Failure — ALM ............................................................................................... 65
7.52 Software Reboot — ALM ............................................................................................ 65
7.53 Too Long to Air Break — ALM..................................................................................... 66
7.54 Too Long to Evacuate — ALM..................................................................................... 67
7.55 Too Long to Extend Draw Tube — ALM ..................................................................... 68
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10099300_C V-PRO®s2 Operator Manual
7.56 Too Long to Fill Reservoir — ALM .............................................................................. 68
7.57 Too Long to Heat Chamber — ALM............................................................................ 68
7.58 Too Long to Heat Vaporizer — ALM........................................................................... 68
7.59 Too Long to Inject — ALM........................................................................................... 69
7.60 Too Long to Inject Fill — ALM ..................................................................................... 69
7.61 Too Long to Lock Door — ALM ................................................................................... 69
7.62 Too Long to Open Door — ALM.................................................................................. 70
7.63 Too Long to Retract Draw Tube — ALM .................................................................... 70
7.64 Too Long to Unlock Door — ALM ............................................................................... 70
7.65 Unit Not Calibrated — ALM......................................................................................... 70
7.66 Vaporizer Overtemp — ALM ....................................................................................... 71
7.67 Vaporizer Temp Deviation — ALM.............................................................................. 71
7.68 Vaporizer Undertemp — ALM ..................................................................................... 71
8 Routine Maintenance ......................................................................................................................72
8.1 Introduction................................................................................................................... 72
8.2 Read Before Performing Routine Maintenance ......................................................... 72
8.3 Routine Operator Maintenance ................................................................................... 73
8.4 Cleaning Sterilization System ...................................................................................... 73
8.5 Leak Test ....................................................................................................................... 76
8.6 Change Printer Paper Roll............................................................................................ 78
8.7 Preventive Maintenance Schedule .............................................................................. 81
8.8 Vacuum Pump Maintenance Indicator ........................................................................ 81
8.9 Replacement Parts ....................................................................................................... 82
9 Printouts...........................................................................................................................................84
10 Appendix A........................................................................................................................................92
10.1 Cleaning, Rinsing and Drying ....................................................................................... 92
10.2 Packaging and Loading................................................................................................. 93
10.3 Extended Lumen/Flexible Cycle Printout Evaluation ................................................. 99
10.4 Extended Non Lumen/Fast Cycle Printout Evaluation.............................................101
11 Appendix B (Supervisor Screens).................................................................................................104
12 Appendix C......................................................................................................................................109
1 — Safety Precautions
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Operator Manual V-PRO®s2 10099300_C
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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10099300_C V-PRO®s2 Operator Manual
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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Operator Manual V-PRO®s2 10099300_C
1.4 DANGER — Personal Injury, Contaminated Load And/Or Equipment Damage Hazard
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND / OR EQUIPMENT DAMAGE HAZARD
Use only Sterilant Cups with Sterilant which has 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 Cycle results in an ineffective Sterilization Cycle. Do not process stainless-steel
lumened devices in a 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.
1 — Safety Precautions
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10099300_C V-PRO®s2 Operator Manual
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.
1 — Safety Precautions
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Operator Manual V-PRO®s2 10099300_C
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.
1 — Safety Precautions
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10099300_C V-PRO®s2 Operator Manual
1.10 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.
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 manufacturer’s instructions.
●All water resistant or immersion caps used in any cleaning procedures MUST BE
removed prior to Sterilization.
When Servicing, do not operate vacuum pump motor (M1) longer than needed to verify
rotation or pump damage might occur.
When Servicing, 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.
IMPORTANT:
Insufficient clearance space makes repairs more difficult and time-consuming. Refer to the equipment drawing for minimum
clearance for service/maintenance access requirements.
2 — Glossary and Symbols
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Operator Manual V-PRO®s2 10099300_C
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.
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.
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 four 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, and Flexible.
Sterilization Unit – V-PRO®s2 Low Temperature Sterilization System.
VAPROX HC Sterilant – STERIS 59% Hydrogen Peroxide Sterilant supplied in Cartridges. VAPROX HC Sterilant also
contains stabilizers making it suitable for STERIS Sterilization Units.
Vac – Volts Alternating Current.
Vdc – Volts Direct Current.
VHP – STERIS proprietary technology utilizing Vaporized Hydrogen Peroxide.
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10099300_C V-PRO®s2 Operator Manual
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 with Sterilant which has 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 (refer to Cleaning,
Rinsing, and Drying).
• 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.
The Sterilization Cycles
DANGER
PERSONAL INJURY, CONTAMINATED LOAD AND/OR EQUIPMENT DAMAGE HAZARD
Processing a load containing a stainless-steel lumened instrument through the Non
Lumen Cycle results in an ineffective Sterilization Cycle. Do not process stainless-steel
lumened devices in a Non Lumen Cycle.
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Operator Manual V-PRO®s2 10099300_C
DANGER
CHEMICAL INJURY HAZARD
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.
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.
This Low Temperature Sterilization System is equipped with four pre-programmed Sterilization Cycles: Lumen Cycle,
Non Lumen Cycle, Fast Cycle, and Flexible Cycle. The operator must choose the appropriate cycle based on the
instruments in the load.
NOTE: A Lumen Cycle is approximately 60 minutes in duration. The Non Lumen Cycle is
approximately 28 minutes in duration. The Fast Cycle is approximately 19 minutes in duration. The
Flexible Cycle is approximately 38 minutes in duration. Some factors that could increase the cycle
time:
•Residual moisture in the load.
•Absorbent materials in the load.
•Load mass and composition.
•Chamber leak rate (refer to Leak Test Section).
This Low Temperature Sterilization Unit Cycles proceed through three phases: CONDITION, STERILIZE, and AERATION.
• CONDITION — This cycle phase consists of the reservoir filling and a timed vacuum pulse to remove air and
moisture from the chamber. When setpoint is reached, load is tested for acceptable moisture content. If content
is acceptable, cycle proceeds (filtered, dry air is introduced to setpoint). If not, control orders a timed evacuation
and load is tested for acceptable moisture content (up to three moisture evacuations). LOAD TEST REPEAT prints
on cycle tape.
NOTE: If Condition phase fails the third moisture check, the cycle aborts.
• STERILIZE — This cycle phase consists of a series of either four pulses (Lumen, Flexible, and Non Lumen Cycles) or
two pulses (Fast Cycle). Each pulse consists of: vacuum pulled to setpoint; Sterilant vapor drawn into chamber;
hold for programmed time; filtered air is introduced to setpoint; hold for programmed time; deep vacuum pulled
to setpoint.
NOTE: Vacuum setpoint is factory set to 0.4 Torr (Lumen and Flexible Cycle) or 1.0 Torr (Non Lumen and Fast
Cycle).
• AERATION — This cycle phase consists of pulling a vacuum to setpoint and continuing to evacuate for the
programmed time. This phase is ordered by the control to reduce chamber vapor concentration. Once Aeration
phase is complete, chamber pressure is brought to atmospheric level and the chamber door unlocks.
2 — Glossary and Symbols
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10099300_C V-PRO®s2 Operator Manual
The Catalytic Converter
Outflow from the chamber passes, during all phases, through a catalytic converter which converts hydrogen peroxide
into water vapor and oxygen. The catalytic converter is used to reduce peroxide concentration to a level below 1.0 ppm.
Cup Level Indicator
A Cup Level indicator (similar to a cell phone battery indicator) is shown on the following screens:
• SELECT CYCLE
• STATUS
• IN STANDBY
• VHP CUP
NOTE: Press Cup Level icon (see Sterilant Cup Information screen) and control displays approximate
number of cycles remaining (assuming sterilant reservoir was empty when cup was installed) as
well as the days remaining before Cup expires.
The Cup Level indicator (see Figure above) is located on the lower right corner of the screen. The control monitors the
number of injections used and updates the indicator as needed. There are five capacity levels shown using bars inside a
simulated cup. The control makes accommodations for aborted cycles and if it is the first cup installed. For normal
operation, each bar represents four cycles. The approximate number of cycles remaining at each bar is as follows:
NOTE: There are two cups available, Standard Ground Shipped Cup (PB011) and the Air Shipped Cup
(PB012).
Standard 20 Cycle Cup (PB011):
• Four bars: 15 - 20 cycles remaining
• Three bars: 10- 15 cycles remaining
• Two bars: 5 - 10 cycles remaining
• One bar: 1 - 5 cycles remaining
• Zero bars: 0 cycles remaining
Air Ship Cup (PB012):
• Four bars: 5 cycles remaining
• Three bars: 3 cycles remaining
• Two bars: 2 cycles remaining
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