BELIMED STEAM STERILIZER MST-H
Device Facts
| Record ID | K141879 |
|---|---|
| Device Name | BELIMED STEAM STERILIZER MST-H |
| Applicant | Sauter AG |
| Product Code | FLE · General Hospital |
| Decision Date | Jun 17, 2015 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
Device Story
Belimed Steam Sterilizer MST-H is a steam-based sterilization system for healthcare facilities. It processes non-porous and porous heat/moisture-stable materials using predefined cycles (PreVac, Gravity, Liquid, Bowie-Dick, Air Leak). The device uses demineralized water to generate steam; operates via PLC control with a 10" TFT color HMI on the loading side and LSC display on the unloading side. It features a cubic welded stainless steel chamber (AISI 316L) and motor-driven doors. The system monitors chamber temperature and pressure via independent sensors; errors trigger acoustic/visual alarms and are recorded on a thermal printer. The device ensures sterility assurance levels (SAL) of 10^-6. It is designed for use by healthcare personnel to sterilize instrument trays and fabric packs, improving workflow through automated cycle management and validated air removal.
Clinical Evidence
Bench testing only. Validation studies performed per ANSI/AAMI ST8:2013. Testing included empty chamber thermal distribution, biological indicator kill-time studies (SAL 10^-6), moisture retention testing (fabrics <3%, instruments <20%), and Bowie-Dick test verification. Liquid cycle validated for 121°C exposure for 12 minutes.
Technological Characteristics
Materials: AISI 316L stainless steel chamber/piping, AISI 321 door. Sensing: Absolute pressure transmitter, temperature sensors. Energy: Steam (250°F, 270°F, 275°F). Connectivity: Thermal printer, PLC-based control. Sterilization: Steam. Standards: ANSI/AAMI ST8:2013, ASME Section VIII Div 1, IEC 61010-1/2-040, UL 61010-1.
Indications for Use
Indicated for sterilization of non-porous and porous heat and moisture-stable materials in healthcare facilities. Not intended for liquids used for direct patient contact.
Regulatory Classification
Identification
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Predicate Devices
- Belimed Steam Sterilizer TOP 5000 Series 9-18 (K021223)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Belimed Sauter AG Michael Hari Head of Medical Engineering Zelgstrasse 8 CH8583 Sulgen, Switzerland
Re: K141879
> Trade/Device Name: Belimed Steam Sterilizer MST-H Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 18, 2015 Received: May 20, 2015
Dear Mr. Hari,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hari
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
## 510(k) Number:
K141879
Device Name: Belimed Steam Sterilizer MST-H
Indications for Use
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H, models 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.
Type of Use (Select one or both, as applicable) □ Prescription Use (Part 21 CFR 801 Subpart D) 区 Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:
| Cycle | Pre-treatment | Sterilizing temperature | Sterilizing Time 1) | Drying time 2) | Recommended load 3) |
|----------------------------|-------------------------------------|-------------------------|---------------------|----------------|-------------------------------------------------------------------------------------------------------|
| PreVac 270<br>4S/30D | 5 pulses | 270 °F | 4 min | 30 min | Double wrapped instrument<br>trays, max. weight of 25 lbs<br>per tray, Fabric packs |
| PreVac 270<br>4S/5D | 5 pulses | 270 °F | 4 min | 5 min | Fabric packs<br>4) |
| PreVac 275<br>3S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrument<br>trays, max. weight of 25 lbs<br>per tray, Fabric packs |
| Bowie-Dick<br>Test | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 270<br>15S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrument<br>trays, with non-porous<br>instruments, max. weight of<br>25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml in<br>vented or open containers 5) |
| Air leak Test | Vacuum: 65mbar<br>Test time: 15 min | - | - | - | Empty chamber |
| Warm up & Air<br>Leak Test | Vacuum: 65mbar<br>Test time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270 °F | 3 min | 3 min | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Notes for Table 1:
- 1. Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
- 2. Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
- 3. Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
- 4. Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
- 5. Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.
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| Model | Instrument trays,<br>max. 25 Ibs each | Fabric Packs,<br>max. 3.3 lbs each |
|--------|---------------------------------------|------------------------------------|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |
The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:
Table 2: Recommended loads for non-porous and porous load cycles
| Model | Volume of liquid in one container | Number of containers |
|--------|-----------------------------------|----------------------|
| 9-6-12 | 1000 ml | 168 |
| 9-6-15 | 1000 ml | 210 |
| 9-6-18 | 1000 ml | 252 |
Table 3: Recommended loads for liquid cycle 250 °F
The Belimed Steam Sterilizer MST-H is offered in the following models:
| Model | Configuration | Net loading<br>capacity (L) | Chamber size<br>(H x W x D) (mm) | Overall Dimensions<br>(H x W x D) (mm) |
|------------|---------------|-----------------------------|----------------------------------|----------------------------------------|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
Table 4: Models and dimensions
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# 510(k) Summary
| Date: | June 10, 2015 |
|-----------------------------|----------------------------------------------------------------------------------------------------|
| Submitter's Name / Address: | Belimed Sauter AG<br>Zelgstrasse 8<br>CH- 8583 Sulgen / Switzerland |
| Contact Person: | Michael Hari<br>Email: michael.hari@belimed.ch<br>Phone: +41 71 644 86 37<br>Fax: +41 71 644 85 11 |
| Trade Name: | Belimed Steam Sterilizer MST-H |
| Models: | 9-6-12, 9-6-15 and 9-6-18 |
| Classification: | Steam Sterilizer – Class II, as listed per 21 CFR 880.6880<br>Product Code: FLE |
| Predicate Device: | Belimed Steam Sterilizer TOP 5000<br>Series 9-18 (K021223) |
## INTENDED USE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
## DESCRIPTION OF DEVICE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.
The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.
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The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:
| Cycle | Pre-treatment | Sterilizing<br>temperature | Sterilizing<br>Time 1) | Drying<br>time 2) | Recommended load<br>3) |
|----------------------------|-------------------------------------|----------------------------|------------------------|-------------------|-------------------------------------------------------------------------------------------------------|
| PreVac 270<br>4S/30D | 5 pulses | 270 °F | 4 min | 30 min | Double wrapped instrument<br>trays, max. weight of 25 lbs<br>per tray, Fabric packs |
| PreVac 270<br>4S/5D | 5 pulses | 270 °F | 4 min | 5 min | Fabric packs<br>4) |
| PreVac 275<br>3S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrument<br>trays, max. weight of 25 lbs<br>per tray, Fabric packs |
| Bowie-Dick<br>Test | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 270<br>15S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrument<br>trays, with non-porous<br>instruments, max. weight of<br>25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml in<br>vented or open containers 5) |
| Air leak Test | Vacuum: 65mbar<br>Test time: 15 min | - | - | - | Empty chamber |
| Warm up & Air<br>Leak Test | Vacuum: 65mbar<br>Test time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270°F | 3 min | 3 min | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Notes for Table 1:
- 1. Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
- 2. Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
- 3. Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
- 4. Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
- 5. Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.
| Model | Instrument trays,<br>max. 25 lbs each | Fabric Packs,<br>max. 3.3 lbs each |
|--------|---------------------------------------|------------------------------------|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |
The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:
Table 2: Recommended loads for non-porous and porous load cycles
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| Model | Volume of liquid in one<br>container | Number of containers |
|--------|--------------------------------------|----------------------|
| 9-6-12 | 1000 ml | 168 |
| 9-6-15 | 1000 ml | 210 |
| 9-6-18 | 1000 ml | 252 |
Table 3: Recommended loads for liquid cycle 250 °F
The Belimed Steam Sterilizer MST-H is offered in the following models:
| Model | Configuration | Net loading<br>capacity (L) | Chamber size<br>(H x W x D) (mm) | Overall Dimensions<br>(H x W x D) (mm) |
|------------|---------------|-----------------------------|----------------------------------|----------------------------------------|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
Table 4: Models and dimensions
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## NONCLINICAL COMPARISON TO PREDICATE DEVICE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are very similar to the predicate device.
A summary of the differences to the predicate device is included in Table 5 :
| General Sterilizer<br>Features | Belimed Steam Sterilizer<br>TOP5000<br>Series 9-18 (K021223) | Belimed Steam Sterilizer<br>MST-H | Substantially<br>Equivalent or<br>Different |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Terminal Sterilization of non-<br>porous and porous heat and<br>moisture-stabile materials used in<br>healthcare facilities | Terminal Sterilization of non-<br>porous and porous heat and<br>moisture-stabile materials used<br>in healthcare facilities | Same |
| Operating Principle | The sterilizing agent of the<br>Belimed Sterilizers MST-H is<br>steam. Steam is made from<br>demineralized water and is<br>therefore non-toxic. Steam is the<br>preferred method to sterilize<br>porous an non-porous heat<br>resistant materials and textiles in<br>hospitals for more than 100 years.<br>Preferred sterilization<br>temperatures are 250 °F, 270 °F<br>and 275 °F. | The sterilizing agent of the<br>Belimed Sterilizers MST-H is<br>steam. Steam is made from<br>demineralized water and is<br>therefore non-toxic. Steam is the<br>preferred method to sterilize<br>porous an non-porous heat<br>resistant materials and textiles in<br>hospitals for more than 100<br>years. Preferred sterilization<br>temperatures are 250 °F, 270 °F<br>and 275 °F. | Same |
| Product code | FLE | FLE | |
| C.F.R: code | 880.6880 Steam Sterilizer | 880.6880 Steam Sterilizer | |
| Class | II | II | |
| Built according to<br>Standard | ANSI/AAMI ST8:1994<br>Hospital Steam Sterilizers | ANSI/AAMI ST8:2013<br>Hospital Steam Sterilizers | Substantially<br>Equivalent,<br>(ST8:2013 uses<br>heavier instrument<br>load and refers to<br>new standard<br>versions) |
| Electrical safety<br>standard | UL 3101-1<br>IEC 61010-1 ed1, am1<br>IEC 61010-2-041 de1 | UL IEC 61010-1: 2004,<br>IEC 61010-2-040:2005 | Substantially<br>Equivalent |
| EMC conformity | IEC / EN 61326:2001 / 2002 | IEC / EN 61326:2001 / 2002 | Same |
| Electrical supply | 3 Phase 208V, 60Hz | 3 Phase 208V, 60Hz | |
| 9-6-9 &9-6-12 | Max. current: 13A | Max. current: 13A | Same |
| 9-6-15 & 9-6-18 | Max. current: 20A | Max. current: 20A | |
| Utility supply pressure<br>requirement<br>Steam<br>Water<br>Compressed air | 2.5 - 3 bar g<br>2 – 5 bar g<br>5 - 7 bar g | 2.5 - 3.5 bar g<br>2 – 5 bar g<br>5 – 7 bar g | Substantially<br>Equivalent |
| Steam capacity<br>requirement:<br>Model 9-6-9<br>Model 9-6-12<br>Model 9-6-15<br>Model 9-6-18 | 120 kg/h<br>160 kg/h<br>200 kg/h<br>240 kg/h | n/a<br>100 kg/h<br>120 kg/h<br>170 kg/h | Lower,<br>Substantially<br>Equivalent |
| Compressed air<br>capacity requirement: | 10 Nm³/h | 10 Nm³/h | Same |
| Cooling water<br>requirement:<br>Model 9-6-9<br>Model 9-6-12<br>Model 9-6-15<br>Model 9-6-18 | 2 m³/h<br>2.5 m³/h<br>3 m³/h<br>3.5 m³/h | n/a<br>2.4 m³/h<br>2.8 m³/h<br>3.2 m³/h | Lower,<br>Substantially<br>Equivalent |
| Control devices | | | |
| Vacuum device<br>Model 9-6-9, 9-6-12<br>Model 9-6-15, 9-6-18 | Water-ring vacuum pump<br>90 m³/h<br>125 m³/h | Water-ring vacuum pump<br>90 m³/h<br>125 m³/h | Same |
| Additional gas ejector /<br>sterilizer runs with<br>max. cooling water<br>temperatures | No/<br>80 °F | Yes, if optional cooling water<br>loop is not installed<br>90 °F | Substantially<br>Equivalent |
| Steam condenser | Shell-and-tube heat exchanger,<br>stainless steel | Shell-and-tube heat exchanger,<br>stainless steel | Substantially<br>Equivalent |
| Air Filtration | 0,2µm, efficiency >99.5%<br>>99.97% for 0.3-micron particles | 0,2µm, efficiency >99.5%<br>>99.97% for 0.3-micron particles | Same |
| Control valves<br>for steam, vacuum and<br>condensate | Stainless steel grade 316 L<br>pneumatically driven piston-valves | Stainless steel grade 316 L<br>pneumatically driven piston-<br>valves | Substantially<br>Equivalent |
| Control valves for<br>cooling water | Brass<br>Electric solenoid valves | Fiber-reinforced plastic material<br>Electric solenoid valves | Substantially<br>Equivalent |
| Piping material grade | AISI 316L | AISI 316L | Same |
| Pressure vessel | | | |
| Chamber and jacket<br>material grade | AISI 316L | AISI 316L | Same |
| Chamber construction | Cubic welded structure with all-<br>round heating ducts | Cubic welded structure with all-<br>round heating ducts | Same |
| Chamber design<br>pressure | 39psi | 40psi | Substantially<br>Equivalent |
| Safety valves | Bronce, ASME approved | Bronce, ASME approved | Same |
| Chamber design<br>standard | ASME Section VIII, Division 1, for<br>unfired pressure vessels | ASME Section VIII, Division 1, for<br>unfired pressure vessels | Same |
| Door material grade | AISI 321 | AISI 321 | Same |
| Door opening | Single or double door<br>Horizontal door operation<br>Motor driven | Single or double door<br>Horizontal door operation<br>Motor driven | Substantially<br>Equivalent |
| Door safety:<br>Door safety bar<br>Additional door locking<br>fixture<br>Number of door limit<br>switches | Yes<br>No<br>Two 'door closed' switches per<br>door | Yes<br>Yes<br>one 'door closed' switch per door<br>and one 'door closed &<br>mechanically locked' switch per<br>door | Substantially<br>Equivalent |
| Door seal | Compressed air activated | Compressed air activated | Same |
| Chamber sizes<br>Model:<br>9-6-9<br>9-6-12<br>9-6-15<br>9-6-18<br>Control | (H x W x D) in mm:<br>1080x660x1040<br>1080x660x1400<br>1080x660x1700<br>1080x660x2000 | (H x W x D) in mm:<br>Not available<br>1080x660x1398<br>1080x660x1706<br>1080x660x2014 | Substantially<br>Equivalent |
| Control Technology | PLC | PLC | same |
| HMI Technology<br>loading side | LCD color / 5,7" | TFT color 10" | Different, larger<br>display |
| HMI Technology<br>unloading side | BT2-2004 LCD display /<br>h x w = 35mm x 68mm | LSC display /<br>h x w=27mmx100mm | Substantially<br>Equivalent |
| Printer Technology | Matrix Dot technology<br>42 char /line, paper width 57mm | Thermal technology<br>42 char /line, paper width 57mm | Substantially<br>Equivalent<br>(same Information<br>on printout) |
| Process control | Automatic through all phases of a<br>cycle | Automatic through all phases of a<br>cycle | Same |
| Sterilization process<br>control | Pressure controlled by an<br>absolute pressure transmitter | Pressure controlled by an<br>absolute pressure transmitter | Same |
| Sterilization process<br>recording | Independent temperature and<br>pressure sensors for recording | Independent temperature and<br>pressure sensors for recording | Same |
| Sterilization process<br>monitoring | Temperature sensor for exposure<br>temperature monitoring | Temperature sensor for exposure<br>temperature monitoring | Same |
| Process alarms | Detected errors cause an acoustic<br>and visual alarm. Alarms are<br>recorded on the printer.<br>At cycle end the door on the<br>unloading side (double door<br>models) can't be opened. Alarms<br>must be manually acknowledged<br>on the load side operating panel. | Detected errors cause an<br>acoustic and visual alarm. Alarms are<br>recorded on the printer.<br>At cycle end the door on the<br>unloading side (double door<br>models) can't be opened. Alarms<br>must be manually acknowledged<br>on the load side operating panel. | Same |
| Cycle phases | All cycle phases and sterilizer status are monitored on display. Display of:<br>-Chamber temperature & pressure<br>-Process status<br>-Door status<br>-Alarms, if pending | All cycle phases and sterilizer status are monitored on display. Display of:<br>-Chamber temperature & pressure<br>-Process status<br>-Door status<br>-Alarms, if pending<br>Additional process status display for cycle state above the chamber (LED bar display) | Substantially<br>Equivalent<br>(Additional<br>information) |
| Cycle end | Acoustic signal at cycle end<br>Cycle end Indication on operating panel display. | Acoustic signal at cycle end<br>Cycle end Indication on operating panel display. | Same |
| Performance: | | | |
| Biological performance | SAL of 10-6 reduction | SAL of 10-6 reduction | |
| (half cycle) | Through achievement of no growth at half cycle with validation loads.<br>AAMI ST8:1994 | Through achievement of no growth at half cycle with<br>validation loads.<br>AAMI ST8:2013 | Same |
| Comply with | | | |
| Moisture retention | Fabrics:<br><3% increase in pre-sterilization textiles test pack weight | Fabrics:<br><3% increase in pre-sterilization textiles test pack weight | |
| Comply with | Instruments<br><20% increase in pre-sterilization towel weight of the test load<br>AAMI ST8: 1994 | Instruments<br><20% increase in pre-sterilization towel weight of the test load<br>AAMI ST8:2013 | Same |
| Factory predefined<br>cycles | | | |
| Prevac 270°F | Yes | Yes | |
| Sterilize temperature | 132°C / 270°F | 132°C / 270°F | |
| Sterilize time | 4 minutes | 4 minutes | |
| Dry time | 20 minutes | 30 minutes | |
| No. of pre-vacuums | 4 | 5 (improved air removal) | |
| Qualified according to | AAMI ST8: 1994 | AAMI ST8:2013 | Substantially<br>Equivalent |
| Test Load | Instrument load in double wrapped trays, full load | Instrument load in double wrapped trays, full load | |
| | 17lbs gross weight per tray…
