GS Series Operators Manual March 2017

™ Sterilizer / Aerator GS Series – Operator’s Manual Table 3M™ of Steri-Vac Contents

Explanation of Symbols... 2 11. Medical Device Packaging and Loading ... 29 14. Routine Maintenance ... 55 Product and package labels and pictograms ...2

11.1. Preparing Medical Devices for Sterilization ...29

14.1. Daily Cleaning ...55

Operator Manual...3

11.1.1. Preparing Endoscopes for EO Sterilization...29

14.2. Air Supply Line Filters ...55

11.2. Packaging Medical Devices...30

14.3. Preventive Maintenance ...56

Content Disclaimers ... 3

11.2.1. Packaging Endoscopes for EO Sterilization...30

1. Description ... 4

11.2.2. Recommended Packaging ...30

15. Cautions, Error Messages, and Troubleshooting ... 57

2. Intended Use... 4

11.2.3. Non-compatible Packaging ...30

15.1. Caution Messages...57

11.2.4. Package Medical Devices ...31

15.2. Error Messages ...58

11.3. Loading the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series...31

15.3. Error Levels and Corrective Actions...59

11.3.1. Loading Recommendations...31

16. Repair and Replacement ... 61

3. Safety ... 5 4. Dangers and First Aid... 6 4.1. Dangers ...6 4.2. First Aid...7

5. Warnings ... 7

11.3.2. Loading Medical Devices and Instruments ...31

12. Operating Instructions ... 32 12.1. Starting a Cycle ...32

6. Cautions ... 8

12.2. Display Screen Indications ...41

7. Specifications... 9

12.3. Overview of GS Series Ethylene Oxide (EO) Sterilization Cycle ...42

7.1. 3M™ Steri-Vac™ Sterilizer/Aerator GS Series Structural Specifications...9 7.2. Sound Levels ...9

12.3.1. Cycle Stages and Descriptions ...42 12.3.2. Cycle Reports...43

7.3. Power Specifications ...9

12.4. Cartridge Dispose Cycle for 3M™ Steri-Gas™ EO Gas Cartridges ...45

7.4. Air Supply Specifications ...10

12.5. Ethernet Connection ...46

8. Compliance and Reference Standards ... 10

12.5.1. Network Connections ...46

8.1. Device Safety Compliance...10

12.5.2. IP Addresses ...46 12.5.3. Software Security ...46

8.2. Electromagnetic Compatibility (EMC) Compliance...10

12.5.4. Software Update...47

9. Installation and Set Up... 11

12.5.5. Firmware Updates ...47

9.1. Environmental Operating Conditions ...11 9.2. Room and Installation Requirements...12 9.3. Set up and Connections ...13

10. Using the Touch Screen... 16 10.1. Main Screen ...16 10.2. Menu ...16 10.3. Reports ...17 10.3.1. Cycle Reports...17 10.3.2. Ethylene Oxide Usage Reports...18 10.3.3. Site Setup Report ...19 10.3.4. Printer Form Feed...20

10.4. Cycle Categories...20 10.4.1. Operator Cycles...20

12.6. Distilled Water Reservoir ...47 12.7. Printer Overview ...48 12.8. Unloading the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series...48 12.8.1. Unloading the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series – Cycle Complete ...49

12.9. Accessing the Chamber during the Aeration Stage ...50 12.10. Empty 3M™ Steri-Gas™ EO Gas Cartridges ...51 12.11. Aeration of a Biological Indicator Process Challenge Device (BI PCD)...51 12.12. Sterilization Cycle Cancellations...51 12.12.1. Manual Cycle Cancellation ...51 12.12.2. Automatic Cycle Cancellation ...51

12.13. Power Outages...51

10.4.2. Supervisor Cycles ...21

13. Process Monitoring and Load Release ... 52

10.5. Setup Menu ...22

13.1. Physical Parameters and Requirements...52

10.5.1. Site Setup ...22 10.5.2. User Setup ...26

13.2. Biological Indicators and Process Challenge Devices ...54

10.6. Status ...28

13.3. Chemical Indicators...54

10.6.1. Control...28

13.3.1. External Chemical Indicator...54

10.6.2. Info ...28

13.3.2. Internal Chemical Indicators ...55

10.6.3. Log ...28

17. Preventive Maintenance ... 61 18. Ordering Accessories and Supplies... 62 Contact Information ...63 U.S. Ordering Information ...63 Orders for Supplies (e.g. 3M™ Steri-Gas™ EO Gas Cartridges, 3M™ Attest™ Biological Indicators, 3M™ Printer Paper)* ...63

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual

Explanation of Symbols: product and package labels and pictograms Refer to the package and product labels to see which symbols apply to specific products. Attention - Refer to the Operator Manual for additional information. Warning - Indicates a hazardous situation, which, if not avoided, could result in death or serious injury. Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive. This symbol indicates that both the device and lithium ion battery contained therein need to be disposed of properly. UL Listed to U.S. and Canadian Safety Standards. Mark of Conformity to European Directives. Compliant to all applicable ACMA regulatory arrangements (RCM). Serial number - This symbol is accompanied by the serial number relevant to the device bearing the symbol. Catalog - This symbol is accompanied by the catalog number relevant to the device bearing the symbol. Authorized representative for the European Community - This symbol is accompanied by the name and the address of the authorized representative in the European Community. Manufacturer - This symbol is accompanied by the name and address of the manufacturer. Date of Manufacture - This symbol is accompanied by the date of manufacture. Do not top load. Lift with forklift. Fragile. Keep dry. This way up. Unique Device Identification (UDI) barcode (located on the sterilizer serial plate). Pictograms are documented according to the European Union (EU) Classification Labeling and Packaging (CLP) Regulation and the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. Flame - Flammable Gas: Category 1 Skull and Cross Bones - Acute Toxicity (inhalation): Category 3 Health Hazards

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Classification Labeling and Packaging (CLP) Regulation Serious Eye Damage/Eye Irritation, Category 2 - Eye Irrit. 2; H319 Skin Corrosion/Irritation, Category 2 - Skin Irrit. 2; H315 Carcinogenicity, Category 1B - Carc. 1B; H350 Germ Cell Mutagenicity, Category 1B - Muta. 1B; H340 Specific Target Organ Toxicity-Single Exposure, Category 3 - STOT SE 3; H335

Globally Harmonized System (GHS) of Classification and Labeling of Chemicals Specific Target Organ Toxicity (single exposure): Category 1 Specific Target Organ Toxicity (repeated exposure): Category 1 Specific Target Organ Toxicity (central nervous system): Category 3 Carcinogenicity: Category 1A Reproductive Toxicity: Category 2 Germ Cell Mutagenicity: Category 1B Eye Irritation: Category 2A Skin Irritation: Category 2

Additional pictograms for Globally Harmonized System (GHS) of Classification and Labeling of Chemicals Gas Cylinder - Gas Under Pressure: Liquefied Gas The gas cylinder pictogram applies to Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. The gas cylinder is not applicable where the European Union (EU) Classification Labeling and Packaging (CLP) Regulation applies. Exclamation Mark - Irritant, Acute toxicity (harmful) Respiratory Tract, Irritation The exclamation mark in red border pictogram applies to Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. The exclamation mark in red border is not applicable where the European Union (EU) Classification Labeling and Packaging (CLP) Regulation applies.

Explanation of Symbols: Operator Manual Danger: Indicates a hazardous situation which, if not avoided, will result in death or serious injury. Warning: Indicates a hazardous situation, which, if not avoided, could result in death or serious injury. Caution: Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury. NOTICE: Indicates a hazardous situation which, if not avoided, may result in property damage.

Content Disclaimers Pictorial Disclaimer Sample printouts, graphics, displays and screens are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual names or test results.

Hardware Disclaimer The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series hardware and software are subject to change. The system images, screen images, hardware components, and hardware specifications included in the manual may not match the system as installed. In the event that hardware or software changes are made, 3M will verify their compatibility with the functionality described in this document.

Serial Number For easy identification, each 3M™ Steri-Vac™ Sterilizer/Aerator GS Series has a unique serial number printed on the serial label (e.g. AA121212 ) found on the right side of the unit and displayed on the printout for each cycle completed.

Record your serial number in this manual for future reference: _____________________________________________________________. 3

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual

1. Description The 3M™ Steri-Vac™ Sterilizer/Aerators GS Series is for use in health care, industrial sterilization, research labs, veterinary surgical and other appropriate settings. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Models GS5 and GS8 and have been validated per US FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities reference 510(k) number K142034. When installed, operated and maintained as described in this operator manual, the equipment is safe and effective. All operators must be fully trained in the recommended operation of this device. The GS Series sterilizer utilizes an embedded software controlled system to ensure that specified sterilization conditions are met and to minimize the possibility of operator exposure to ethylene oxide (EO) gas. Use of this equipment in a manner not specified by 3M has not been evaluated and may lead to an unsafe condition. Sterilizers have two preprogrammed sterilization cycles, 38 °C and 55 °C. Critical cycle parameters are detailed in Table 1. The GS Series sterilizer EO sterilization cycles consist of ten (10) stages. After the sterilization cycle is complete, an aeration cycle is required to remove any residual EO from the medical devices per manufacturers’ instructions for use (IFUs). An EO sterilization cycle is defined as a treatment in a sealed, temperature-controlled chamber comprised of air removal, conditioning, and injecting of EO, exposure to EO, removal of EO and flushing, aerating, and air admission allowing the opening of the chamber door. Figure 1 is a graph of a pressure profile of the cycle stages of a GS Series EO sterilization cycle. 10. Air Admission

Atmospheric Pressure

1. Chamber Preheating

Pressure

9. Aeration

6. EO Exposure 2. Air Removal

8. Flushing 5. EO Injection

3. Chamber Test

7. EO Removal

4. Conditioning

Time

Figure 1. Pressure Profile GS Series EO Sterilization Cycle

2. Intended Use The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles:

Model

Cycle

Gas Expose Time (min.)

Temperature (°C)

EO Concentration (mg/L)

Relative Humidity (%)

Cool

270

38

736

40-80

Warm

60

55

736

40-80

Cool

270

38

759

40-80

Warm

60

55

759

40-80

GS5

GS8

Table 1. GS Series Critical Cycle Parameters Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instrument’s sterilization instructions. The load per cycle should not exceed 20 lumens. CAUTION: To reduce the risk of injury, always follow the procedures described in this manual. 4

3. Safety The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series was developed with the safety of operators and patients in mind. The GS Series sterilizers are designed with state-of-the-art safety features that include: • Hardware and mechanical components of the GS Series sterilizers meet or exceed the compliance requirements of current, recognized national and international safety standards including applicable sections of IEC 61010-1 (2010), IEC 61010-2-010 (2014), IEC 61010-2-040 (2015) and ANSI/AAMI ST24, and EN1422. • The sterilization process is performed completely under a vacuum. If the system integrity is compromised during ethylene oxide (EO) gas exposure, room air will enter the chamber. In this situation, the system will detect a rise in pressure and will safely cancel the cycle when the system cannot maintain a vacuum. Sterilization and aeration can be conducted within the same chamber. Aeration in the sterilization chamber eliminates the need to transfer product loads outside the sterilization chamber when longer aeration times are required. • EO sterilant is delivered in single-dose cartridges placed inside the sterilization chamber. The use of single-dose cartridges reduces the risk of leaking ethylene oxide delivery lines and EO tank changes and provides increased control of sterilant quality. • GS Series sterilizers are designed with an internal processor that automatically controls and independently monitors the physical process parameters to ensure sterilization conditions are maintained throughout the sterilization cycle. The GS Series sterilizers’ embedded software regulates, independently monitors, and records critical sterilization process parameters including pressure, temperature, and percent relative humidity (%RH) during conditioning. • Automatic fault notification and safe state recovery processes provide additional protection for the Operator. If the GS Series sterilizer detects a cycle fault, an error message will alert the Operator. Additionally, an optional audible notification will accompany the error code message. Immediately after detecting a fault, the GS Series sterilizer will automatically complete an error recovery process to bring the sterilizer to a safe-state prior to further action. • GS Series sterilizers are designed with a state-of-the-art proprietary humidification process. In the Conditioning stage of the sterilization cycle, GS Series sterilizers contain a custom 3M designed humidification process that adds, measures, adapts, and controls %RH to accommodate different loads and packaging materials to achieve proper humidification prior to EO gas injection. • Control and monitor sensors detect critical sterilization process parameters. GS Series sterilizers have control sensors for temperature, %RH, and pressure that provide information to the control embedded software. The sterilizer has a duplicate set of monitoring sensors that provide independent data and performance monitoring to an independent monitoring processor during critical sterilization stages for temperature, %RH, and pressure. • Over-the-door vent hood (i.e. exhaust hood) supplements the room’s directional air flow, and draws air away from Operators removing a load from the chamber. • The GS Series sterilizers are designed with a specialized disposal cycle for full damaged, expired, or excess 3M™ Steri-Gas™ EO Gas Cartridges. The Cartridge Dispose Cycle is a custom, abbreviated cycle that safely empties and aerates the Steri-Gas EO Gas Cartridges at a rate of one per cycle. Disposal cycles have restricted access to a Supervisor PIN only. The GS Series sterilizers and their related devices and accessories are designed to provide safe and reliable service when used according to the provided instructions for use. Please read, understand, and follow all safety information contained in the instructions for use prior to using a sterilizer. Use this equipment only for the purpose described in this Operator Manual. Retain these instructions for future reference. If this equipment is used in a manner not specified, the protection provided by the equipment may be impaired. In addition, recommended practices for the safe and effective use of EO are also contained in the Association for the Advancement of Medical Instrumentation ANSI/AAMI ST41: Ethylene oxide sterilization in health care facilities: Safety and effectiveness. It is the user’s facility management’s responsibility to ensure that all personnel who operate or maintain the equipment are trained in its operation and safe use. There are no formal safety inspections required by the Operator. It is the user’s facility management’s responsibility to assure safety inspections are complete. Contact your local 3M Health Care service personnel or authorized 3M service personnel for required safety inspections. DANGER: To reduce the risks associated with exposure to ethylene oxide: It is the user’s facility management’s responsibility to ensure that all personnel working with toxic chemicals, gases, and vapors are given comprehensive instruction in their use. This instruction includes information on relevant health hazards, national regulations, methods for safe use, and methods to detect the escape of the agent. It is the user’s facility management’s responsibility to ensure regular training of all personnel involved with the operation and maintenance of the equipment, including emergency procedures for any toxic, flammable, or explosive material released into the environment and to maintain records of attendance and evidence of demonstrated understanding from training sessions. National regulation regarding limitations on airborne EO concentration in the workplace exist in the United States and may exist in your country or region as well. Good practice should include a risk analysis of the EO gas sterilization processes, a written Emergency Response Plan, and an Employee Notification plan for EO leaks. The following warnings and precautions should be observed to avoid unsafe actions that could result in personal injury or damage to the instrument.

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3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual

4. Dangers and First Aid DANGER: Potential health effects of ethylene oxide Users in the United States must follow the requirements of the United States Occupational Exposure Standard for Ethylene Oxide OSHA (29 CFR 1910.1047). 100% ethylene oxide (EO) CAS number 75-21-8 is a colorless gas at ambient conditions. Do not rely on sense of smell for the detection of ethylene oxide. EO has a high odor threshold and can only be detected by sense of smell when it exceeds 500 - 750 parts per million (PPM). EO has a characteristic ether-like odor (i.e. a sweet and irritating solvent smell).

4.1. Dangers

DANGER: To reduce the risks associated with exposure to ethylene oxide: Ensure a minimum of ten (10) air exchanges per hour (ACH’s) for the room in which the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is installed. Inspect display screen and cycle reports for error codes and listen for audible notifications (if enabled). Always take action for error codes as indicated in this manual. Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration. Do not overload the sterilization chamber. Use good practices for loading the sterilizer chamber. Never use force to access the inside of the sterilization chamber. Always review the elapsed aeration time on the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series display prior to opening the sterilizer door. Always inspect cycle reports (printout or electronic) to ensure the total aeration time matches the device manufacturer’s instructions for use (IFU). Do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside specified environmental conditions as stated in this manual. Only use 3M™ Steri-Gas™ EO Gas Cartridges as listed in this manual. Do not use other brands or types of sterilant cartridges. Do not force the 3M™ Steri-Gas™ EO Gas Cartridges into the cartridge holder as excessive force could damage the cartridge and result in a cartridge leak. Do not use damaged 3M™ Steri-Gas™ EO Gas Cartridges. If an individual 3M™ Steri-Gas™ EO Gas Cartridge is ever dropped, the cartridge should be used immediately or disposed of as described in the cartridge disposal section of this manual. Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes. Do not sterilize leather, liquids, or materials reactive to EO. Ensure that the compressed air supply is clean, with a maximum allowable dirt particle size of 0.5 microns, and that the air supply is free of oil. Ensure that the air filters on the compressed air supply contain a water trap and are cleaned daily (if applicable) and are properly maintained. Call 3M Health Care service personnel or authorized 3M service personnel immediately if there is a failure of the display or backlight and the sterilizer continues to operate. It is the user’s facility management’s responsibility to ensure that all personnel working with toxic chemicals, gases, and vapors are given comprehensive instruction in their use. This manual includes information on relevant health hazards, national regulations, methods for safe use, and methods to detect escape of the agent. It is the user’s facility management’s responsibility to ensure regular training of all personnel involved with the operation and maintenance of the equipment, including emergency procedures for any toxic, flammable, or explosive material released into the environment and to maintain records of attendance and document evidence of demonstrated understanding from training sessions.

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4.2. First Aid Inhalation: Move person to fresh air and seek medical attention.

Skin or Clothing Contact: Immediately wash with soap and water. Remove contaminated clothing and wash clothing before reuse. If signs/symptoms develop, seek medical attention.

Eye Contact: Immediately flush with large amounts of water for at least 15 minutes. Remove contact lenses if easy to do so. Continue rinsing. Immediately seek medical attention.

If Swallowed: Rinse mouth. DO NOT INDUCE VOMITING. Immediately seek medical attention.

Hazard statements of ethylene oxide (EO): • Extremely flammable gas • Contains gas under pressure, may explode if heated • Toxic if inhaled • Causes serious eye irritation • May cause drowsiness or dizziness • Suspected of damaging fertility or an unborn child • May cause cancer • May cause genetic defects

Consult the 3M™ Steri-Gas™ EO Gas Cartridge Safety Data Sheet (SDS) for additional information (www.3M.com).

5. Warnings WARNING: To reduce the risks associated with fire and explosion: 3M™ Steri-Gas™ EO Gas Cartridges contain 100% ethylene oxide (EO) which is an extremely flammable gas and a liquid under pressure. Do not use near flame, electrical sparks, hot surfaces, or allow sources of ignition near the cartridges. Do not puncture cartridge outside the sterilization chamber. Do not incinerate cartridges. Exposure to temperatures above 150ºF (65.5ºC) may cause cartridge to burst. 3M™ Steri-Gas™ Cartridge Catalog Number

3M™ Steri-Vac™ Sterilizer GS Series Model

Nominal Net Weight of EO

4-100

GS5 Series

EO Net wt. 100 g. (3.52 oz.)

8-170

GS8 Series

EO Net wt. 170 g. (5.99 oz.)

Do not sterilize devices with energy sources which could create a spark in the sterilization chamber during the sterilization cycle. Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration. Inspect display screen and cycle reports for error codes and listen for audible notifications (if enabled). Always take action with error codes as indicated in this manual. Do not attempt to access any internal mechanisms of the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. Operators should not service the GS Series sterilizer as there are no user serviceable parts. WARNING: To reduce the risk of shock due to hazardous voltage: Do not attempt to access any internal mechanisms of the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. Operators should not service the GS Series sterilizer as there are no user serviceable parts. Customer must provide a properly grounded outlet (an earth ground) for installation as described in the installation requirements section of this manual. Do not use a detachable cord rated less than 15A. Do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual. Use only 3M Health Care service personnel or authorized 3M service personnel for installation and maintenance. Do not modify any part of 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. 7

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual

6. Cautions CAUTION: To reduce the risk of injury: Always follow the procedures described in this manual. Follow good ergonomic practices. Loading baskets should not be overfilled requiring excessive force in pulling and pushing loaded baskets in and out of the sterilizer chamber. Reference facility policies and procedures for appropriate ergonomic practices.

CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures: Inspect display screen and cycle reports for error codes and listen for audible notifications (if enabled). Always take action for error codes as indicated in this manual. Always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual. Always use chemical indicators and biological indicators per the device manufacturer’s instructions for use (IFU). Always inspect cycle reports (printout or electronic file) to ensure the device manufacturer’s instructions for use (IFU) matches: • %RH at the End of Conditioning, • Temperature at the End of Conditioning, • Actual Gas Exposure Time. Complete maintenance at routine scheduled intervals of a maximum of every six (6) months. There are no user-serviceable parts. Only use 3M Health Care service personnel or authorized 3M service personnel for maintenance. Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration. Do not overload the sterilization chamber. Use good practices for loading the sterilizer chamber. Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes. Do not sterilize leather, liquids, or materials reactive to EO. Only use 3M™ Steri-Gas™ EO Gas Cartridges as listed in this manual. Do not use other brands or types of sterilant cartridges. Do not force the 3M™ Steri-Gas™ EO Gas Cartridges into the cartridge holder. Excessive force could damage the cartridge and result in a cartridge leak. Do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual. Immediately call 3M Health Care service personnel or authorized 3M service personnel if there is a failure of the display or backlight and the GS Series sterilizer continues to operate. Do not modify any data or records from the sterilizer system which may lead to misinterpretation of physical monitor results. Do not place any device emitting strong electronic magnetic fields (EMFs) near the sterilizer.

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7. Specifications 7.1. 3M™ Steri-Vac™ Sterilizer/Aerator GS Series Structural Specifications GS5

GS8

Shipping Weight

163 kg (359 lbs.) single door 169 kg (373 lbs.) double door

355 kg (782 lbs.) single door 362 kg (799 lbs.) double door

Operational Weight

127 kg (281 lbs.) single door 132 kg (290 lbs.) double door

261 kg (576 lbs.) single door 269 kg (593 lbs.) double door

Exterior Dimensions

H 70.9 cm x W 76.2 cm x D 95.0 cm H 27.9 in. x W 30.0 in. x D 37.4 in.

H 179.8 cm x W 94.0 cm x D 109.0 cm H 70.8 in. x W 37.0 in. x D 42.9 in.

Chamber Internal Volume

136 L (4.8 cubic feet)

224 L (7.9 cubic feet)

Chamber Internal Dimensions

H 38.0 cm x W 43.0 cm x D 83.0 cm H 15.0 in. x W 17.0 in. x D 32.5 in.

H 46.0 cm x W 51.0 cm x D 97.0 cm H 18.0 in. x W 20.0 in. x D 38.0 in.

7.2. Sound Levels The average decibel level of an active GS5 or GS8 sterilizer is <60 dBA. For more information on sound levels, in the US contact 3M Health Care Helpline at 1-800-228-3957. Outside the US contact your local 3M office or to locate your local office go to www.3M.com

7.3. Power Specifications

WARNING: To reduce the risk of shock due to hazardous voltage, the customer must provide a properly grounded outlet (an earth ground) for installation as described in the installation requirements section of this manual. Do not use a detachable cord rated less than 15A.

CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures, do not place any device emitting strong electronic magnetic fields (EMFs) near the sterilizer. Electrical Power

Operating Condition

Units

Voltage Range

200 - 240

VAC

Frequency

50/60

Hertz

Phase

Single

Not Applicable

GS5 Current

10

Amps

GS8 Current

12

Amps

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3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual 7.4. Air Supply Specifications

DANGER: To reduce the risks associated with exposure to ethylene oxide, ensure that the compressed air supply is clean, with a maximum allowable dirt particle size of 0.5 microns, and that the air supply is free of oil. Ensure that the air filters on the compressed air supply contain a water trap and are cleaned daily (if applicable) and are properly maintained. Air Supply Feature

Specification

Pressure

7.0 kg/cm2 (100 psig) minimum to 10.5 kg/cm2 (150 psig) maximum

Flow Rate

2.2 liters per second at 7.0 kg/cm2 (4.7 standard cubic feet per minute at 100 psig) per sterilizer based on 100% duty cycle compressor

Quality

Clean air supply with a maximum allowable dirt particle size of 0.5 microns and free of oil

Moisture Content

Less than 10°C (50°F) dew point

8. Compliance and Reference Standards 8.1. Device Safety Compliance The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is an instrument, Class II medical device, per the U.S. Food and Drug Administration (FDA) classification scheme. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is a Class IIb medical device per the European Union Medical Device Directive (MDD 93/42/EEC) classification scheme. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the following standards as demonstrated by the CB Scheme Certificate and test report issued by the Underwriters Laboratories (UL): • IEC / EN 61010-1 (2001, 2010, CSA 2nd Ed:2008, 2nd Ed:2013, 3rd Ed:2012) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • IEC / EN 61010-2-010 (2003, 3rd Ed:2014) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials. • IEC / EN 61010-2-040 (2005, 2015) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical devices. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is listed as Laboratory Electrical Equipment for Use in Health Care Applications (Certified for Canada) and carries the UL mark with adjacent indicators “C” and “US” based on compliance to the standards UL 61010-1 and CAN/CSA 22.2 No. 61010-1. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the RoHS Directive, Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment. In the European Union, the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series are certified as exempt from the scope of the ATEX Directive.

8.2. Electromagnetic Compatibility (EMC) Compliance The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the following EMC standards as confirmed in the Certificate of Compliance generated by 3M: • IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the EMC requirements of the CE mark EMC Directive 2004/108/EC. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the Australian EMC requirements as confirmed in the Supplier’s Declaration of Conformity that is linked to the RCM Mark. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide a reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates and can radiate radio frequency energy; and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his/her own expense. In addition, operation of this device must accept any interference received, including interference that may cause undesired operation. This Class A digital equipment meets all requirements of the Canadian Interference-Causing Equipment Regulations.

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9. Installation and Set Up To ensure proper operation of this equipment and Operator safety, the 3M™ Steri-Vac™ Site Planning and Installation Guide must be followed and the equipment must be installed by authorized 3M service personnel. To arrange installation, contact your local 3M subsidiary (www.3m.com). WARNING: To reduce the risk of shock due to hazardous voltage, only use 3M Health Care service personnel or authorized 3M service personnel for installation and maintenance.

9.1. Environmental Operating Conditions

DANGER: To reduce the risks associated with exposure to ethylene oxide, do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual.

WARNING: To reduce the risk of shock due to hazardous voltage, do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual.

CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures, do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual. Environmental Condition

Operating Condition

Units

Altitude

2500 (max)

Meters

*Operating Temperature

15 - 35

ºC

Operating Relative Humidity

20 - 80 (non-condensing)

%RH

Installation/ Transient Over Voltage Pollution Degree

Category II 2

*Note: Operating the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series in a temperature environment that is close to the sterilization process temperature set point (e.g. 35ºC operating environment and a 38ºC sterilization process temperature set point) may result in a temperature fault during the sterilization process.

11

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual 9.2. Room and Installation Requirements

DANGER: To reduce the risks associated with exposure to ethylene oxide, ensure a minimum of ten (10) air exchanges per hour (ACHs) for the room in which the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is installed. Location

Do not place the sterilizer or ethylene oxide (EO) cartridges in an area of possible ignition sources. ONLY USE INDOORS.

Room Size

Greater than 30m3 (1,000 ft3)

Spacing

Allow 51cm (20 inches) of clearance space at the top, rear, and sides of the sterilizer for maintenance and service and a minimum of 10cm (4 inches) from the rear wall for single door units. Ensure sufficient space

Ventilation

Negative pressure with a minimum of ten (10) air exchanges per hour. The ventilation system should be non-recirculating and dedicated.

Air Flow

Air flow washes the entire room. Air movement is away from the sterilizer Operator. See Figure 2.

ACCEPTABLE or

UNACCEPTABLE Exhaust

Exhaust

Intake

Exhaust Sterilizer

Sterilizer Intake

“Dead” Air Space

Air flow washes entire room. Air movement is away from operator.

Air movement is toward operator and “dead” air spaces can form.

Figure 2. Acceptable and Unacceptable Installation Air Flow

12

9.3. Set up and Connections Figures 3 - 7 illustrate the components and connections for the 3M™ Steri-Vac™ Sterilizer/Aerator Series, Models GS5 and GS8. Table 2 contains additional details regarding specific components and connections for the GS Series Models GS5 and GS8.

Chamber Door Touch Screen & Display Water Reservoir, Printer & USB Ports Access Door Cartridge Scanner Bay Printer & USB Ports Access Door Water Reservoir Access Door

Figure 3. Front View 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Models GS5 & GS8

4. Abator (optional) 3. Ethernet (optional) 2. Power Switch

6. Chamber Exhaust (Ethylene Oxide Vent Line)

1. Power Cord 5. Air Inlet

Figure 4. Left Side Connections 3M™ Steri-Vac™ Sterilizer/ Aerator GS Series

13

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual 7. Vent Hood Exhaust

Figure 5. Top Connection - 3M™ Steri-Vac™ Sterilizer/Aerator GS Series

8. User Screen

9. USB Ports 10. EO Gas Cartridge Barcode Scanner

11. Printer w/ Paper

12. Distilled Water Reservoir

Figure 6. Front Panel - 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Model GS8

8. User Screen

11. Printer with Paper 12. Distilled Water Reservoir

14

9. USB Ports 10. EO Gas Cartridge Barcode Scanner

Figure 7. Front Panel - 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Model GS5

Connection Or Component Number

Connection Or Component Name

1

Power Cord

Use the supplied power cord for connection of the system to a properly grounded outlet as specified in the 3M™ Steri-Vac™ Site Planning and Installation Guide. Ensure there is adequate space at installation to disconnect the power cord when required. Do not use a detachable cord rated less than 15A.

2

Power Switch

The power switch turns power to the GS Series sterilizer OFF and ON. The switch is intended to remain ON at all times in order to simplify operation and to allow the sterilizer electronics to continually monitor sterilizer functions. It is recommended to keep the power ON at all times unless otherwise instructed by 3M Health Care service personnel or authorized 3M service personnel.

Ethernet

The Ethernet connection is not required for normal operation of the system. Connecting to Ethernet provides 3M Health Care Service with a means to access Service diagnostic information on the GS Series sterilizer from a desktop computer located on-site within the clinic network. 3M Health Care Service can access cycle information, reports (e.g. calibration, site setup) and service diagnostic information directly on the sterilizer. Devices connected to the Ethernet port must be 60950-1 (General Requirements for Information Technology Safety) compliant. Do not connect devices that are not compliant to 60950-1. Reference Chapter 12 for additional information.

4

Abator

The Abator connection is only provided for connection to an emission control device (i.e. an EO Abator), only if such a device is required by local laws/codes. Do not connect any other device to this connector. Abator connection is for sterilizer communication to an emission control device. Abator installation may be optional and not required for the normal operation of the system but is required in some localities. The Abator connection is intended to only be made by 3M Health Care service personnel or authorized 3M service personnel during installation.

5

Air Inlet

Air inlet is for the connection of the compressed air supply per Chapter 9 and is intended for use only by trained 3M Health Care service personnel or 3M authorized service personnel.

6

Chamber Exhaust (Ethylene Oxide Vent Line)

Connect the GS Series sterilizer to a dedicated vent line in order to exhaust ethylene oxide (EO) to the outside atmosphere or to an emission control device, an EO Abator. The requirements for venting the sterilizer must be met as documented in the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series Site Planning and Installation Guide and is intended to be made only by 3M Health Care service personnel or authorized 3M service personnel.

7

Vent Hood Exhaust

The over-the-door vent hood (i.e. exhaust hood) supplements the room’s directional air flow and is designed to draw air away from Operators removing a load from the chamber. The hood is connected by 3M Health Care service personnel or authorized 3M service personnel to a customer supplied dedicated exhaust system during installation of the sterilizer. The vent hood (i.e. exhaust hood) is monitored for an adequate standard cubic feet per minute (SCFM) air flow rate. If the sterilizer detects the air flow is too low (< 125 SCFM) through the vent hood, the sterilizer door will remain locked until a minimum of three (3) hours of aeration is fulfilled. Monitoring of the vent hood air flow is optional and can be disabled by an authorized 3M service provider in the Site Setup<Setup Tab - Options Set (Figure 24, Chapter 10). If vent hood monitoring is disabled, there will be no caution message if the air flow SCFM is too low (< 125 SCFM) and the sterilizer door will remain locked until a minimum of three (3) hours of aeration is fulfilled

8

User Screen

User and display screen for the Operator interface with the sterilizer control features. See Chapter 10 for more details.

9

USB Ports

The USB ports are available for Universal Serial Bus (USB) drives to export multiple types of cycle reports, sterilizer and cycle settings, See Chapter 10 for more details. Recommended USB drives include drives with FAT32 formatting. Drives with pre-loaded software (e.g. SanDisk’s Cruzer®) are not recommended. Only USB drives, for the sole purpose of exporting and importing data and cycles, are to be connected to the USB ports. Do not connect external USB devices that supply power. See Chapter 10 for more details.

10

3M™ Steri-Gas™ EO Gas Cartridge Barcode Scanner

Location of cartridge scanner bay. Scanning the 3M™ Steri-Gas™ EO Gas Cartridge bar code ensures that the cartridge is valid for use. See Chapter 12 for more details.

11

Printer w/ Paper

The built-in printer provides easy-to-read information for each sterilization cycle. The printer can also be used to print multiple types of cycle reports, in addition to sterilizer and cycle settings. The cycle report printout is essential in analyzing the GS Series sterilizer performance and can be retained to meet cycle verification policies. See Chapter 12 for more details.

12

Distilled Water Reservoir

Distilled water is used for humidification of the EO sterilization process. Ensure the distilled water reservoir is adequately filled. The GS Series sterilizer will display an error message if the distilled water level is too low to run a sterilization cycle. Do not overfill water reservoirs.

Not Numbered

Location of the temperature sensor used for process control

The temperature sensor used for process control is located inside the sterilizer chamber, protruding from the right side chamber wall bottom section, towards the loading chamber door.

3

Connection Or Component Description

Table 2. Sterilization Connection and Component Explanations

15

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual

10. Using the Touch Screen 10.1. Main Screen Figure 8 shows the Main Screen of the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series that appears after the power cycles ON. A double door sterilizer will have an additional button on the Main Screen for the option to open the Unload door. The Operator controls the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series via a touch screen. A fingertip, stylus, ball tip pen or a computer mouse can be safely used to navigate the touch screens. To use a computer mouse, simply plug the mouse into one of the two USB ports (reference Figures 6 and 7) and the mouse arrow will appear on the touch screen. Sterilizer

22.2˚C

98.0 kPa

1

3

2

4

04/20/2015 05:19:51

5

6

7

Select cycle temperature:

38 °C

55 °C

Figure 8. GS Series Sterilizer Main Screen Menu

Open door

10.2. Menu The Menu button in the bottom left hand corner is used to access the following options: Reports, Cycles, Setup, Status and Service. Figure 9 shows the Menu options screen.

Sterilizer

22.2˚C

98.0 kPa

1

3

2

4

04/20/2015 05:19:52

5

6

7

Select cycle temperature:

Reports Cycles

38 °C

55 °C

Setup Status Service

16

Figure 9. GS Series Sterilizer Menu Options

10.3. Reports The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series has a variety of reporting options as shown in Figure 10. Sterilizer

22.2˚C

98.0 kPa

1

3

2

4

04/20/2015 05:19:53

5

6

7

Select cycle temperature:

Reports

Cycle reports

Cycles

EO usage report

Setup

Site setup report

Status

Printer form feed

55 °C

Figure 10. Reports Menu

Service

10.3.1. Cycle Reports Figure 11 outlines the options for 3M™ Steri-Vac™ Sterilizer/Aerator GS Series Cycle Reports. Sterilizer Print or export report

22.2˚C

04/20/2015 12:29:13

98.0 kPa

Cycle 33 - 4/20/2015 - 55 ˚C Cycle 32 - 4/19/2015 - 38 ˚C Cycle 31 - 4/18/2015 - 55 ˚C Cycle 30 - 4/17/2015 - 55 ˚C Cycle 29 - 4/16/2015 - 55 ˚C Aeration Cycle 28 - 4/15/2015 - 55 ˚C Cycle 27 - 4/12/2015 - 38 ˚C Cycle 26 - 4/11/2015 - 55 ˚C Cycle 25 - 4/10/2015 - 55 ˚C

Print selected cycle Export selected cycle Export all cycles Report format Graph Control sensors

Monitor sensors

Temperature

Temperature

Pressure

Pressure

Relative humidity

Relative humidity

Figure 11. Cycle Report Setup Enter Pin

Return

OK

Reports from the last 100 cycles can be printed or exported electronically to a USB drive. When the 100 cycle limit is reached, the oldest cycles are replaced with the most recently run cycles. Select the desired cycle(s) from the list of the last 100 cycles (sorted with the most recently run cycles at the top) and select the desired function from the following options: print selected cycle, export selected cycles, or export all cycles. Only one cycle may be selected for printing. Multiple cycles can be selected for export to a USB drive. To export electronic reports, insert a USB drive (data storage device) into one of two USB ports on the GS Series sterilizer. Recommended USB drives include those with FAT32 formatting. USB drives with pre-loaded software (e.g. SanDisk’s Cruzer®) are not recommended. Connect only USB drives for the export of data to the USB ports. Do not connect external USB devices that supply power to the USB ports. Select the cycle(s) for which you wish to export reports and press the OK button. The selected reports are stored in the USB directory selected by the user. The sterilizer will ask for confirmation of the Folder designation before export. The electronic reports are generated in color and are sized as 20.3 cm (8 in.) x 27.9 cm (11 in.) images and contain the same information as the strip chart reports. The GS Series sterilizer has control sensors for temperature, %RH, and pressure that provide information to the control embedded software. In addition, the sterilizer has a duplicate set of monitoring sensors that provide independent data and performance monitoring during critical sterilization stages for temperature, %RH, and pressure. The sterilizer defaults to report only on the control sensors. Monitoring sensors can be selected for reporting in the Cycle Report options screen in Figure 11. 17

3M™ Steri-Vac™ Sterilizer / Aerator GS Series – Operator’s Manual There are three (3) Cycle Report formats. The desired format can be selected in the Cycle Report options screen (Figure 11). Each of the Cycle Report formats is described in Chapter 12 in Table 5.

22.2˚C

Sterilizer Print or export report

04/20/2015 12:30:30

98.0 kPa

Cycle 33 - 4/20/2015 - 55 ˚C Cycle 32 - 4/19/2015 - 38 ˚C Cycle 31 - 4/18/2015 - 55 ˚C Cycle 30 - 4/17/2015 - 55 ˚C Cycle 29 - 4/16/2015 - 55 ˚C Aeration Cycle 28 - 4/15/2015 - 55 ˚C Cycle 27 - 4/12/2015 - 38 ˚C Cycle 26 - 4/11/2015 - 55 ˚C Cycle 25 - 4/10/2015 - 55 ˚C

Print selected cycle Export selected cycle Export all cycles Report format Graph Graph Control sensors Table Temperature Detailed

Monitor sensors Temperature

Pressure

Pressure

Relative humidity

Relative humidity

Figure 12. Selecting Report Formats Enter Pin

Return

OK

10.3.2. Ethylene Oxide Usage Reports Generate a report for ethylene oxide (EO) usage from the Menu>Reports>EO Usage Report screen. Generate an EO Usage Report for specific dates as illustrated in Figure 13. View the report on the display screen, print the report directly from the sterilizer, or export electronically to a USB drive. Figure 14 is an example of a printed EO Usage Report. Sterilizer

22.2˚C

98.0 kPa

1

3

04/20/2015 12:30:30

EO usage report

Start date 2 04/19/2015

4

5

6

7

End date Select cycle temperature: 05/01/2015

EO usage report AA 121212 04/20/2015 12:30:55 Software version 1.0.1 _________________________

55 °C

Sterilizer ID = Machine 2 Start date = 04/19/2015 End date = 05/01/15 Total cycles = 10 Total EO weight (kg/lb) = 1.00/2.20*

Figure 13. Selecting Dates for EO Usage Reports

* The documentedd Total EO weight is Cancel

18

Export

Print

EO usage report AA 121212 04/20/2015 12:30:55 Software version 1.0.1 ---------------------------------Sterilizer ID = Machine 2 Start date = 04/19/2015 End date = 05/01/15 Total cycles = 10 Total EO weight (kg/lb) = 1.00/2.20*

*The documented Total EO weight is based on the NOMINAL fill weight of 100% Ethylene Oxide. The ACTUAL fill weight may be different. ACTUAL fill weight met all 3M specifications at the time of product release. ----------------------------------

Figure 14. Printed EO Usage Report

10.3.3. Site Setup Report View a Site Setup Report for the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series by viewing, printing, or exporting electronically to a USB drive via Menu>Reports>Site Setup Report. The Site Setup Report contains the site settings established in the Site Setup menu. Figure 15 is the display screen view of the Site Setup Report. Sterilizer

22.2˚C

98.0 kPa

1

3

04/20/2015 12:30:30

Site setup report

2

4

5

6

7

Site setup report AA 121212 04/20/2015 12:32:52 Select1.0.1 cycle temperature: Software version _________________________ Preferences Audible tone on cycle failure = Yes Audible tone on cycle complete = Yes Print on cycle complete = No Cycle report preference = Graph Sensors to plot = Control Screen timeout = 10 minutes Idle mode chamber temperature = 35 ˚C Pressure unit = kPa User count = 38 Abated aeration time = 0.0 hours Setup Abated aeration time

t

Cancel

Export

55 °C

Figure 15. Display Screen View of the Site Setup Report

Print

19