(108 days)
Not Found
No
The document describes a standard steam sterilizer with a control system that monitors and sequences cycle phases. There is no mention of AI, ML, or any learning or adaptive capabilities.
No
The device is a steam sterilizer, used to sterilize medical instruments and linens, not to provide therapy directly to a patient.
No
Explanation: This device is a steam sterilizer, used for sterilizing surgical instruments and other items in healthcare facilities, which is a treatment/prevention function, not a diagnostic one.
No
The device is a steam sterilizer, which is a piece of hardware designed to sterilize medical items using pressurized steam. While it has a control system (likely software-driven), the core function and description are centered around the physical sterilizer unit and its operation.
Based on the provided information, the Getinge 700HC-E Series Steam Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical devices (surgical instruments, linens) for reuse in healthcare facilities. This is a process applied to medical devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a steam sterilizer, which is a piece of equipment used for sterilization, not for analyzing samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
Therefore, the Getinge 700HC-E Series Steam Sterilizer falls under the category of a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).
The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Factory recommended cycles were tested per industry standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.
The results of Getinge 700HC-E Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:
- Empty chamber testing performed for all cycles as described in ANSI/AAMI ST8:2008 Hospital Steam Sterilizers section 5.4.2.5. The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load.
- All PREVAC and GRAVITY cycles were validated using fabric process challenge packs as described in ANSI/AAMI ST8:2008 section 5.5.2. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots.
- All PREVAC (excluding PREVAC 2 and PREVAC 5 that have shortened drying times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8:2008 section 5.5.4. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete BI kill and moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper.
- All Immediate Use (Flash) cycles were validated using a unwrapped non-porous process challenge device as described in ANSI/AAMI ST8:2008 section 5.5.5. The results from this testing demonstrated a sterility assurance level of at least 10 6 through achievement of time at temperature sufficient to produce an Fo value of at least 12 and complete BI kill.
- Liquid loads cycles were validated using 3 one liter flasks as described in ANSI/AAMI ST8:2008 section 5.5.3. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and water loss not exceeding 50ml.
- Bowie Dick cycle was validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2008 section 5.6.1.1.
- The software validation for the cycle operation was performed according to FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sterility assurance level of at least 10°, Fo value of at least 12, complete Bl kill, moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots, moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper, water loss not exceeding 50ml.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Getinge Model 400HC/500HC Series Steam Sterilizer [K103504]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6880 Steam sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
MAY 3 1 2012
Getinge 700HC-E Series Steam Sterilizer
| Submitted by: | Getinge Sourcing LLC
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Barb Smith, RAC
Sr. Manager, Regulatory Affairs
Phone: (585) 214-6049
Fax: (585) 272-5299 |
| Date prepared: | February 6, 2012 |
| Proprietary Name: | Model 700HC-E Series Steam Sterilizer |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)
Class II, as listed per 21 CFR 880.6880 |
| Predicate Device: | Getinge Model 400HC/500HC Series Steam Sterilizer [K103504] |
Description of Device:
The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).
The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
1
List of available cycles: Model 733HC-E Steam Sterilizer Cycles and Load Chart
| Cycle Type | No. of
Cycles | Factory Settings | | | Load Configuration
(Note 1) | Maximum Items per
Chamber Length | | |
|-----------------------------------|------------------|----------------------|------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------|--------------------|--------------------|
| | | Exp.
Temp. | Exp.
Time | Drying
Time | | 1.00 m
(39 in.) | 1.35 m
(53 in.) | 1.55 m
(61 in.) |
| vac
PREVAC | 5 | 135.0°C
(275.0°F) | 3 min | 16 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric Packs | 24 | 32 | 48 |
| vac
PREVAC 2 | 3 | 135.0°C
(275.0°F) | 3 min | 3 min
(Note 4) | Fabric Packs | 24 | 32 | 48 |
| vac
PREVAC 4 | 1 | 132.2°C
(270.0°F) | 4 min | 16 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| vac
PREVAC 5 | 1 | 132.2°C
(270.0°F) | 4 min | 3 min
(Note 4) | Fabric packs | 24 | 32 | 48 |
| vac
B & D TEST | 1 | 133.9°C
(273.0°F) | 3 min,
30 sec | 0 min | S.M.A.R.T. Pack or
equivalent (1 max.) in
an EMPTY chamber | 1 Test
Pack | 1 Test
Pack | 1 Test
Pack |
| grv
GRAVITY 1 | 4 | 121.1°C
(250.0°F) | 30 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| grv
GRAVITY 2 | 3 | 135.0°C
(275.0°F) | 10 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| grv
GRAVITY 3 | 1 | 132.2°C
(270.0°F) | 10 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| ius
IMMEDUSE 1
(Notes 1, 7) | 1 | 135.0°C
(275.0°F) | 3 min | 30 sec
(Note 4) | Unwrapped,
nonporous
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 3 | 3 | 3 |
| liq
LIQUIDS 1 | 1 | 121.1°C
(250.0°F) | 30 min | 5.17
kPa/min
(0.75
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or
smaller
(Notes 5, 6, 8) | 112 | 154 | 196 |
| liq
LIQUIDS 2 | 1 | 121.1°C
(250.0°F) | 45 min | 5.17
kPa/min
(0.75
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or
smaller
(Notes 5, 6, 8) | 112 | 154 | 196 |
| lk
LEAK TEST
(Note 2) | 1 | 131.1°C
(268.0°F) | 3 min. | 15 min
dry, 5
min
equalize
15 min
test | Empty Chamber
(other than loading
accessories) | - | - | - |
2
Getinge Sourcing LLC FDA 510/k) Summary MAHALE Sprige Staam Starilize
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAMI Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 and were made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
-
- Vacuum leak test parameters are not adjustable.
-
- Cooldown rate
-
- Items may NOT be dry at the end of the following cycles:
- · IMMEDUSE 1
- · PREVAC2
- PREVAC5
Drying time may be added if required.
-
- Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
-
- Use vented or open containers only.
-
- The recommended minimum exposure time and temperature for unwrapped, nonporous loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 135°C (275°F).
-
- A small load of 1000mL (34 fl oz) containers requires an exposure time of 45 min.
3
Intended Use:
The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Comparisons to Predicate Device:
Similarities between the Getinge 700HC-E Series Steam Sterilizer and the identified predicate are:
- Intended use is the same: Intended for use by health care facilities to sterilize . wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
- Operating Principle is the same: Saturated steam is the sterilizing agent. ●
- Materials of construction are the same: Vessel material is Stainless Steel . SA240-316Ti. There is no direct patient contact associated with this device.
- Cvcle Types: The cvcle types offered are the same; Prevac (135°C, 132°C), . Gravity (121°C, 132°C, 135°C), Immediate Use (135°C) and Liquids 121°C (not for sterilization of liquids used directly for patient contact).
- Performance Testing: Factory recommended cycles were tested per industry . standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.
The differences between the Getinge 700HC-E Series Steam Sterilizer and the predicate device (Getinge 400HC/500HC Series Steam Sterilizer) are:
- The Getinge 700HC-E Series Steam Sterilizer has larger vessel sizes. . Because of the larger vessel size the chamber closure (door operation and door retaining method) are different. Also the larger chamber sizes require different piping and steam to chamber design to accommodate the increased chamber volume. The larger chamber size also allows for larger loads to be processed. Factory recommended maximum load sizes are tested for effectiveness and clearly identified in product labeling.
- The Getinge 700HC-E Series Steam Sterilizer has an updated larger display. . The updated display provides four run screen formats as opposed to three and allows the user to interact with the controls by means of a touch screen.
4
Summary of Performance Testing:
Factory recommended cycles were tested per industry standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.
The results of Getinge 700HC-E Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:
- Empty chamber testing performed for all cycles as described in ANSI/AAMI . ST8:2008 Hospital Steam Sterilizers section 5.4.2.5. The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load.
- All PREVAC and GRAVITY cycles were validated using fabric process . challenge packs as described in ANSI/AAMI ST8:2008 section 5.5.2. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots.
- All PREVAC (excluding PREVAC 2 and PREVAC 5 that have shortened drying . times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8:2008 section 5.5.4. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete BI kill and moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper.
- All Immediate Use (Flash) cycles were validated using a unwrapped non-. porous process challenge device as described in ANSI/AAMI ST8:2008 section 5.5.5. The results from this testing demonstrated a sterility assurance level of at least 10 6 through achievement of time at temperature sufficient to produce an Fo value of at least 12 and complete BI kill.
- Liquid loads cycles were validated using 3 one liter flasks as described in . ANSI/AAMI ST8:2008 section 5.5.3. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and water loss not exceeding 50ml.
- Bowie Dick cycle was validated using the Bowie-Dick test pack as described in . ANSI/AAMI ST8:2008 section 5.6.1.1.
5
- The software validation for the cycle operation was performed according to . FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)".
Clinical Data:
No clinical data is required for this device classification submission.
Conclusion:
The 700HC-E Series Steam Sterilizer has the same intended use and technological characteristics as the predicate device. The 700HC-E Series Steam Sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards. Based on the information provided in this premarket notification, it can be concluded that the subject device is substantially equivalent to the predicate device and effective when used as intended.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Barb Smith Senior Manager Regulatory Affairs Getinge Sourcing, LLC 1777 East Henrietta Road Rochester, New York 14623-3133
MAY 3 1 2012
Re: K120441
Trade/Device Name: Getinge 700HC-E Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: II Product Code: FLE Dated: May1, 2012 Received: May 2, 2012
Dear Ms. Smith:
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 Eederal Register.
7
Page 2- Ms. Smith
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For G.P. Sheldrick M.D.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
8
510(k) Number (if known): K120441
Device Name: Getinge 700HC-E Series Steam Sterilizer
Indications for Use:
The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3 Page 1 of
Edi, litt F. Clamine-Well
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K12044 510(k) Number:
9
List of available cycles:
Getinge 700HC-E Series Steam Sterilizer Model 733HC-E Cycles and Load Chart
| Cycle Type | No. of
Cycles | Factory Settings | | | Load Configuration
(Note 1) | Maximum Items per
Chamber Length | | |
|-----------------------------------|------------------|----------------------|------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------|--------------------|--------------------|
| | | Exp.
Temp. | Exp.
Time | Drying
Time | | 1.00 m
(39 in.) | 1.35 m
(53 in.) | 1.55 m
(61 in.) |
| vac
PREVAC | 5 | 135.0°C
(275.0°F) | 3 min | 16 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | Fabric Packs | 24 | 32 | 48 | |
| vac
PREVAC 2 | 3 | 135.0°C
(275.0°F) | 3 min | 3 min
(Note 4) | Fabric Packs | 24 | 32 | 48 |
| vac
PREVAC 4 | 1 | 132.2°C
(270.0°F) | 4 min | 16 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | Fabric packs | 24 | 32 | 48 | |
| vac
PREVAC 5 | 1 | 132.2°C
(270.0°F) | 4 min | 3 min
(Note 4) | Fabric packs | 24 | 32 | 48 |
| vac
B & D TEST | 1 | 133.9°C
(273.0°F) | 3 min,
30 sec | 0 min | S.M.A.R.T. Pack or
equivalent (1 max.) in
an EMPTY chamber | 1 Test
Pack | 1 Test
Pack | 1 Test
Pack |
| grv
GRAVITY 1 | 4 | 121.1°C
(250.0°F) | 30 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| grv
GRAVITY 2 | 3 | 135.0°C
(275.0°F) | 10 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| grv
GRAVITY 3 | 1 | 132.2°C
(270.0°F) | 10 min | 45 min | Double-wrapped
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 10 | 15 | 20 |
| | | | | | Fabric packs | 24 | 32 | 48 |
| ius
IMMEDUSE 1
(Notes 1, 7) | 1 | 135.0°C
(275.0°F) | 3 min | 30 sec
(Note 4) | Unwrapped,
nonporous
instrument trays, up
to 11.3 kg (25.0 lb)
(per tray) | 3 | 3 | 3 |
| liq
LIQUIDS 1 | 1 | 121.1°C
(250.0°F) | 30 min | 5.17
kPa/min
(0.75
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or
smaller
(Notes 5, 6, 8) | 112 | 154 | 196 |
| liq
LIQUIDS 2 | 1 | 121.1°C
(250.0°F) | 45 min | 5.17
kPa/min
(0.75
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or
smaller
(Notes 5, 6, 8) | 112 | 154 | 196 |
| lk
LEAK TEST
(Note 2) | 1 | 131.1°C
(268.0°F) | 3 min. | 15 min
dry, 5
min
equalize
, 15 min
test | Empty Chamber
(other than loading
accessories) | - | - | - |
. . . . .
10
3.55 K120441
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- The load configurations listed in these tables are those used during testing validations of the sterilizer. The load configurations follow AAM Standard ST8: Hospital steam sterliizers where applicable (fabric packs are These conligerations form of in ANSI/AAMI ST8 and were made to be consistent with the packs process than one of the STS). For guidance on processing loads in the sterilizer, refer to AAM Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
-
Vacuum leak test parameters are not adjustable.
-
Cooldown rate
-
Items may NOT be dry at the end of the following cycles:
- · IMMEDUSE 1
- · PREVAC2
- · PREVAC5
.
Drying time may be added if required.
-
Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
-
Use vented or open containers only.
-
- The recommended minimum exposure time and temperature for unwrapped, loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 135°C (275°F).
- A small load of 1000 mL (34 fl oz) containers requires an exposure time of 45 min.