3M™ Steri-Vac™ Sterilizer/Aerator GS Series Operator’s Manual T3aMbl™e  oSft eCroi‑nVteanct™s Sterilizer / Aerator GS Series – Operator’s Manual Explanation of Symbols2 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 Explanation of Symbols: Operator Manual ������������������������������3 11�2� Packaging Medical Devices �����������������������������������������29 14�2� Air Supply Line Filters ��������������������������������������������������55 Content Disclaimers 3 1121 Recommended Packaging 29 14�3� Preventive Maintenance ����������������������������������������������56 1122 Non‑compatible Packaging 30 1 Description 4 1123 Package Medical Devices 30 15 Cautions, Error Messages, and Troubleshooting 57 15�1� Caution Messages �������������������������������������������������������57 2 Intended Use 4 11�3� L oading the 3M™ Steri‑Vac™ Sterilizer/Aerator GS Series �����������������������������������������30 15�2� Error Messages �����������������������������������������������������������58 3 Safety 5 1131 Loading Recommendations 31 15�3� Error Levels and Corrective Actions �����������������������������59 4 Dangers and First Aid 6 1132 Loading Medical Devices and Instruments 31 16 Repair and Replacement 61 4�1� Dangers ���������������������������������������������������������������������������6 12 Operating Instructions 32 17 Preventive Maintenance 61 4�2� First Aid����������������������������������������������������������������������������7 12�1� Starting a Cycle �����������������������������������������������������������32 12�2� Display Screen Indications ������������������������������������������41 18 Ordering Accessories and Supplies62 5 Warnings 7 12�3� O verview of GS Series Ethylene Oxide (EO) Contact Information ��������������������������������������������������������������63 6 Cautions 8 Sterilization Cycle ��������������������������������������������������������42 U�S� Ordering Information �����������������������������������������������������63 7 Specifications9 1231 Cycle Stages and Descriptions 42 Orders for Supplies (e�g� 3M™ Steri‑Gas™ 1232 Cycle Reports 43 7�1� 3 M™ Steri‑Vac™ Sterilizer/Aerator GS Series EO Gas Cartridges, 3M™ Attest™ Biological Indicators, Structural Specifications��������������������������������������������������9 12�4� C artridge Dispose Cycle for 3M™ Steri‑Gas™ 3M™ Printer Paper)* �����������������������������������������������������������63 EO Gas Cartridges �������������������������������������������������������45 7�2� Sound Power Levels Specifications ���������������������������������9 12�5� Ethernet Connection ����������������������������������������������������46 7�3� Power Specifications �������������������������������������������������������9 1251 Network Connections 46 7�4� Air Supply Specifications �����������������������������������������������10 1252 IP Addresses 46 8 Compliance and Reference Standards 10 1253 Software Security 46 1254 Software Update 47 8�1� Device Safety Compliance ���������������������������������������������10 1255 Firmware Updates 47 8�2� Electromagnetic Compatibility (EMC) Compliance ���������10 12�6� Distilled Water Reservoir ���������������������������������������������47 9 Installation and Set Up 11 12�7� Printer Overview ����������������������������������������������������������48 9�1� Environmental Operating Conditions �����������������������������11 12�8� U nloading the 3M™ Steri‑Vac™ Sterilizer/Aerator GS Series �����������������������������������������48 9�2� Room and Installation Requirements �����������������������������12 1281 Unloading the 3M™ Steri‑Vac™ 9�3� Set up and Connections ������������������������������������������������13 Sterilizer/Aerator GS Series – Cycle Complete 49 10 Using the Touch Screen 16 12�9� Accessing the Chamber during the Aeration Stage �����50 10�1� Main Screen ����������������������������������������������������������������16 12�10� E mpty 3M™ Steri‑Gas™ Ethylene Oxide (EO) Gas Cartridges ���������������������������������������������������51 10�2� Menu ���������������������������������������������������������������������������16 12�11� Aeration of a Biological Indicator Process 10�3� Reports ������������������������������������������������������������������������17 Challenge Device (BI PCD) ������������������������������������������51 1031 Cycle Reports 17 12�12� Sterilization Cycle Cancellations ��������������������������������51 1032 Ethylene Oxide Usage Reports 18 12121 Manual Cycle Cancellation 51 1033 Site Setup Report 19 12122 Automatic Cycle Cancellation 51 1034 Printer Form Feed 20 12�13� Power Outages ����������������������������������������������������������51 10�4� Cycle Categories ����������������������������������������������������������20 13 Process Monitoring and Load Release 52 1041 Operator Cycles 20 1042 Supervisor Cycles 21 13�1� Physical Parameters and Requirements ����������������������52 10�5� Setup Menu �����������������������������������������������������������������22 13�2� Biological Indicators and Process Challenge Devices��54 1051 Site Setup 22 13�3� Chemical Indicators �����������������������������������������������������54 1052 User Setup 26 1331 External Chemical Indicator 54 10�6� Status ��������������������������������������������������������������������������28 1332 Internal Chemical Indicators 55 1061 Control 28 1062 Info 28 1063 Log 28 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 W aste 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 A uthorized 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. 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 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 2 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 (eg 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: _____________________________________________________________ 2 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 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 Atmospheric Pressure 10. Air Admission 1. Chamber Preheating 9. Aeration e ur 6. EO Exposure s s e 2. Air Pr Removal 8. Flushing 5. EO 7. EO Injection Removal 3. Chamber 4. Conditioning Test 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: EO Concentration Model Cycle Gas Expose Time (min.) Temperature (°C) (mg/L) Relative Humidity (%) Cool 270 38 736 40‑80 GS5 Warm 60 55 736 40‑80 Cool 270 38 759 40‑80 GS8 Warm 60 55 759 40‑80 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/EN61010‑1, 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 (ie 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 4 5 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 19101047) 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 (ie 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 05 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 6 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 (655ºC) 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 (352 oz) 8‑170 GS8 Series EO Net wt 170 g (599 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 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 6 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 8 7 Specifications 7.1. 3M™ Steri‑Vac™ Sterilizer/Aerator GS Series Structural Specifications GS5 GS8 163 kg (359 lbs) single door 355 kg (782 lbs) single door Shipping Weight 169 kg (373 lbs) double door 362 kg (799 lbs) double door 127 kg (281 lbs) single door 261 kg (576 lbs) single door Operational Weight 132 kg (290 lbs) double door 269 kg (593 lbs) double door H 709 cm x W 762 cm x D 950 cm H 1798 cm x W 940 cm x D 1090 cm Exterior Dimensions H 279 in x W 300 in x D 374 in H 708 in x W 370 in x D 429 in Chamber Internal Volume 136 L (48 cubic feet) 224 L (79 cubic feet) H 380 cm x W 430 cm x D 830 cm H 460 cm x W 510 cm x D 970 cm Chamber Internal Dimensions H 150 in x W 170 in x D 325 in H 180 in x W 200 in x D 380 in 7.2. Sound Power Levels Specifications GS5 GS8 A‑weighted < 85 dBa < 85 dBa 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  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 7 Amps GS8 Current 12 Amps 8 9