Steris V-Pro S2 Low Temperature Sterilization System Operating instructions

Brand: Steris

Model: V-Pro S2 Low Temperature Sterilization System

Type: Operating instructions

10099300

Revision C

V-PRO®s2

Low Temperature Sterilization System

Operator Manual

10099300_C V-PRO®s2 Operator Manual

Published: 2023-4-26

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.

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

≥ 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.

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

≥ 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).

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.

Operator Manual V-PRO®s2 10099300_C

Addresses

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

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

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

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

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

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

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

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

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

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

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.

2 — Glossary and Symbols

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.

2 — Glossary and Symbols

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

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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Steris V-Pro S2 Low Temperature Sterilization System Operating instructions

Brand: Steris

Model: V-Pro S2 Low Temperature Sterilization System

Type: Operating instructions

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Steris V-Pro S2 Low Temperature Sterilization System Operating instructions

Steris V-Pro S2 Low Temperature Sterilization System Operating instructions

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