Aesculap SterilContainer System Instructions for...
Transcript of Aesculap SterilContainer System Instructions for...
Aesculap® SterilContainer™ System
Instructions for Use
Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities
Instructions for Use Intended for US Only
As of July 2019
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 2 of 71
Table of Contents 1.0 PURPOSE OF INSTRUCTIONS FOR USE .......................................................................................................................... 4
2.0 STERILCONTAINER SYSTEM ............................................................................................................................................ 4
3.0 STERILCONTAINER SYSTEM REPAIRS ............................................................................................................................ 7
4.0 DECONTAMINATION AND CLEANING PROCESS ........................................................................................................... 8
5.0 INSPECTION PRIOR TO USE ........................................................................................................................................... 12
6.0 PREPARATION AND ASSEMBLY OF STERILCONTAINER SYSTEM ............................................................................. 15
7.0 STERILCONTAINER SYSTEM STERILIZER CYCLE PARAMETERS — STEAM AND ETO ............................................. 21
8.0 STERILCONTAINER SYSTEM STERILIZER CYCLE PARAMETERS — ASP STERRAD® ................................................. 29
9.0 STERILCONTAINER SYSTEM STERILIZER CYCLE PARAMETERS — STERIS® V-PRO® .............................................. 38
10.0 ASEPTIC PRESENTATION ............................................................................................................................................... 46
11.0 STERILE CONTAINER VALIDATION SUMMARY ........................................................................................................... 49
12.0 CUSTOMER VERIFICATION ............................................................................................................................................ 51
13.0 INDICATIONS FOR USE .................................................................................................................................................. 56
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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List of Figures
List of Images
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1.0 Purpose of Instructions for Use
2.0 SterilContainer System
ONLY
Product Family SterilContainer SterilContainer S SterilContainer S2
Bottom Series
JK JN JM
JS
Lid Series3, 5 JK PrimeLine4 PrimeLine Pro4 JK PrimeLine4 PrimeLine Pro4 JM JS
PreVac Steam X X X X X X X X
PreVac IUSS X X X
Gravity X X X
EtO X X X
Low Temp
STERRAD1 X X
Low Temp STERIS2 X X
Figure 1: SterilContainer System
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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Primary Name Which Includes May Also Be Referred to As
Figure 2: Sterilizations Modality Nomenclature and SterilContainer System Compatibility
JK Solid Bottom JS Perforated Bottom,
Identified by the Gold Handle & Latch
JN Perforated Bottom JK Solid Bottom JN Perforated Bottom JS Perforated Bottom
Identified by the Gold Handle & Latch
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Figure 3: SterilContainer System Basket Options
Basket Series JB JC JE JF
Figure 4: Container Basket Features
Image 1: Single Use Processing Supplies, Filters, Tamper Evident Locks, Indicator Cards
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Notes:
3.0 SterilContainer System Repairs
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ONLY Aesculap trained technicians are authorized to repair the Aesculap SterilContainer System. Using a
non-Aesculap repair technician to repair containers will void the Aesculap Warranty on the container and may
void any of the validation testing associated with Aesculap containers.
Notes:
4.0 Decontamination and Cleaning Process
DO NOT USE
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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4.1 Water Quality
4.1.1 Utility Water
4.1.2 Critical Water
4.2 Detergent Solutions
Notes:
DO NOT USE
4.3 Decontamination and Mechanical Cleaning
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Figure 5: PrimeLine Pro Lid Inspection Process
Notes:
DO NOT USE
DO NOT USE
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4.4 Decontamination and Manual Cleaning
Notes:
DO NOT USE
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As of July 2019 Page 12 of 71
DO NOT USE
DO NOT USE
5.0 Inspection Prior to Use PRIOR TO EVERY USE
DO NOT USE
Notes:
5.1 SterilContainer System Inspection Criteria
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Image 2: JK, JN and JM Lid Reusable Filter Inspection
Image 3: Filter Retention Plates and Silicone Gaskets Inspection Process
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Image 4: PrimeLine Lid Inspection Process
Notes:
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5.2 Basket, Tray and Accessory Inspection Criteria
6.0 Preparation and Assembly of SterilContainer System PRIOR TO EVERY USE
ONLY
Filter Type PreVac Steam PreVac IUSS Gravity EtO Low Temp
Paper Filter
w/ Indicator1
Paper Filter
w/o Indicator
Polypropylene Filter
w/o Indicator
Metal Retention Plate Lid
PTFE Reusable Filter
PrimeLine & PrimeLine Pro
PTFE Reusable Filter2
Figure 6: Filters for Perforated Bottoms and Lids
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Notes:
6.1 SterilContainer System Assembly ONLY USE
Image 5: Aluminum Lid with Metal Retention Plate and Reusable Filter
Image 6: Aluminum Lid with Metal Retention Plate and Single Use Filer Assembly
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Image 7: PrimeLine Lid Inspection Process
Notes:
6.2 Assembly of Surgical Instrumentation
6.3 Loading of Basket, Lifting Platform and Tray
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Notes:
Full-Size, Three-Quarter Size, Half-Size Wide-Body, Extra-Long Container
Extra-Long Mini-Size Container
Mini-Size and Quarter-Size Container
6.4 Internal Process Indicators
Notes:
6.5 External Process Indicators and Tamper Evident Seals
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Tamper Evident Locks PreVac Steam PreVac IUSS Gravity EtO Low Temp
Blue / US900
Green / US905
Orange / US906
Pink / US9102
Yellow / US399
The recommended post sterilization indicator color may not be evenly shaded but should be shades of the
proper processed color to indicate exposure to sterilant
Figure 7: Tamper Evident Locks
Installation Instructions for All Tamper Evident Locks
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Indicator &
Communication Cards PreVac Steam PreVac IUSS Gravity EtO Low Temp
MD334, MD335
w/ Indicator
MD346, MD876, US754
w/ Indicator
US963
w/o Indicator
MD399, MD345
w/ Indicator
The recommended post sterilization indicator color may not be evenly shaded but should be shades of the proper processed
color to indicate exposure to sterilant.
Figure 8: Indicator and Communication Cards
Notes:
amper Evident Locks US900, US905, US906 and US399
DO NOT USE
Tamper Evident Lock US910
DO NOT USE
Indicator & Communication Cards MD334, MD335
DO NOT USE
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6.6 Container Storage and Transportation
DO NOT
7.0 SterilContainer System Sterilizer Cycle Parameters — Steam and EtO
Steam and EtO modalities
ONLY
7.1 Steam and EtO Sterilization Modality Cycle Parameters
Primary Name Which Includes May Also Be Referred to As
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7.1.1 PreVac Steam Sterilization Cycle Parameters (1)
°
7.1.2 PreVac IUSS Sterilization Cycle Parameters (2)
Porous Instruments
°
Non-Porous Instruments
°
ONLY
7.1.3 Gravity Steam Sterilization Cycle Parameters (3)
7.1.4 EtO Cycle Parameters (4)
7.1.5 PreVac Steam Sterilization Cycle Parameters (5)
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Notes:
Detailed Size Description Abbreviation Size Description
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7.1.6 Steam and EtO – SterilContainer JK Series
JK Series
Bottom Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
Wide
XLL
1:1
3:4
1:2
Wide
XLL
Filter
Indicator
Card
Lock
Mini Mini
Filter
Indicator
Card
Lock
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7.1.7 Steam and EtO – SterilContainer JK Series with PrimeLine Pro / PrimeLine Lid
1:1
3:4
1:2
1:1
3:4
1:2
Filter, LidB
Filter, Bottom
Indicator
Card
Lock
JK Series
Bottom Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
1:1
3:4
1:2
Filter, LidB
Filter, Bottom
Indicator
Card
Lock
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7.1.8 Steam and EtO – SterilContainer JN Series
JN Series
Bottom
Aluminum
Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
XLL
Wide
1:1
3:4
1:2
XLL
Wide
Filter
Indicator
Card
Lock
Qtr
Mini
XLM
Qtr
Mini
XLM
Filter
Indicator
Card
Lock
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7.1.9 Steam and EtO – SterilContainer JN Series, PrimeLine Pro / PrimeLine Lid
JN Series
Bottom Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
1:1
3:4
1:2
Filter, LidB
Filter, Bottom
Indicator
Card
Lock
1:1
3:4
1:2
1:1
3:4
1:2
Filter, LidB
Filter, Bottom
Indicator
Card
Lock
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7.1.10 Steam and EtO – SterilContainer JM Series
JM Series
Bottom
Aluminum
Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
1:1
3:4
1:2
Filter
Indicator
Card
Lock
Mini
XLM
Mini
XLM
Filter
Indicator
Card
Lock
7.1.11 Steam and EtO – SterilContainer JS Series
JS Series
Bottom
Aluminum
Lid
Processing
Supplies
Validated and FDA 510(k) Cleared Sterilization Modalities
Max Total
WeightA
1:1
3:4
1:2
1:1
3:4
1:2
Filter
Indicator
Card
Lock
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8.0 SterilContainer System Sterilizer Cycle Parameters — ASP STERRAD®
Low Temperature modality when used with ASP STERRAD
sterilizers
ONLY
Notes:
NOT
NOT
NOT
Detailed Size Description Abbreviation Size Description
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1 STERRAD Sterilization Modality Cycle Parameters
Primary Name Which Includes May Also Be Referred to As
STERRAD
100S 200
NX1
Standard
NX1
Advanced
100NX1
Standard
100NX1
Flex
100NX1
Express
JM Series
JS Series
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1.1 STERRAD 100S Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERRAD 100S
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1.2 STERRAD 100S Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERRAD 100S
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
8.1.3 STERRAD 200 Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERRAD 200
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1.4 STERRAD NX Standard Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERRAD NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
8.1.5 STERRAD NX Standard Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERRAD NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
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8.1.6 STERRAD NX Advanced Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERRAD NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
8.1.7 STERRAD NX Advanced Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERRAD NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
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8.1.8 STERRAD 100NX Standard Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERRAD 100NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
8.1.9 STERRAD 100NX Standard Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERRAD 100NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1.10 STERRAD 100NX FLEX Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies STERRAD 100NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
8.1.11 STERRAD 100NX FLEX Cycle — SterilContainer S2 JS Series
Size Bottom Processing Supplies STERRAD 100NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Notes:
o o o
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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8.1.12 STERRAD 100NX Express Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies STERRAD 100NX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.0 SterilContainer System Sterilizer Cycle Parameters — STERIS® V-PRO®
Low Temperature modality when used with STERIS V-PRO
sterilizers
ONLY
Notes:
NOT
NOT
NOT
Detailed Size Description Abbreviation Size Description
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1 STERIS Sterilization Modality Cycle Parameters
Primary Name Which Includes May Also Be Referred to As
STERIS
V-PRO 60 maX1
Lumen Non-Lumen Flexible Flexible Lumen Non-Lumen
JM Series
JS Series
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1.1 STERIS V-PRO 60 Lumen Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
EfficacyB
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1.2 STERIS V-PRO 60 Lumen Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
EfficacyB
Max Total
WeightA
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1.3 STERIS V-PRO 60 Non-Lumen Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Filter
Indicator
Card
Lock
9.1.4 STERIS V-PRO 60 Non-Lumen Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1.5 STERIS V-PRO 60 Flexible Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
9.1.6 STERIS V-PRO 60 Flexible Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO 60
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Notes:
o o
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9.1.7 Amsco STERIS V-PRO maX Flexible Cycle — SterilContainer S JM Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO maX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
9.1.8 Amsco STERIS V-PRO maX Flexible Cycle — SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO maX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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9.1.9 Amsco STERIS V-PRO maX Lumen Cycle— SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO Max
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
9.1.10 Amsco STERIS V-PRO maX Non-Lumen Cycle— SterilContainer S2 JS Series
Size Bottom Lid Processing Supplies
STERIS
V-PRO maX
Efficacy
Max Total
WeightA
Filter
Indicator
Card
Lock
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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10.0 Aseptic Presentation
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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As of July 2019 Page 47 of 71
For Reference Only
Filter Type PreVac Steam PreVac IUSS Gravity EtO Low Temp
Paper Filter
w/ Indicator1
Paper Filter
w/o Indicator
Polypropylene Filter
w/o Indicator
Metal Retention Plate
PTFE Reusable Filter
PrimeLine & PrimeLine Pro
PTFE Reusable Filter
Tamper Evident Locks PreVac Steam PreVac IUSS Gravity EtO Low Temp
Blue / US900
Green / US905
Orange / US906
Pink / US9102
Yellow / US399
The recommended post sterilization indicator color may not be evenly shaded but should be shades of the
proper processed color to indicate exposure to sterilant
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 48 of 71
For Reference Only
Indicator &
Communication Cards PreVac Steam PreVac IUSS Gravity EtO Low Temp
MD334, MD335
w/ Indicator
MD346, MD876, US754
w/ Indicator
US963
w/o Indicator
MD399, MD345
w/ Indicator
The recommended post sterilization indicator color may not be evenly shaded but should be shades of the
proper processed color to indicate exposure to sterilant.
10.1 SterilContainer System Reference Guidelines
Figure 9: Easy Reference Handout
10.2 SterilContainer System Transportation to Decontamination
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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11.0 Sterile Container Validation Summary
11.1 Validation Testing
11.1.1 Reprocessing Validation and Verification
11.1.2 Sterilization Efficacy
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11.1.3 Sterility Maintenance
Event Related Storage Study
Aerosol Challenge Test
Notes:
11.2 Aesculap SterilContainer System and FDA Clearances
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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Container System DescriptionFDA 510(k)
Clearance
References:
12.0 Customer Verification validate
verify
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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As of July 2019 Page 52 of 71
Placement of Chemical and Biological Indicators for Product Testing
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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AAMI ST79 Guideline Aesculap Product Placement
Example of External Chemical Indicators
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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Example placement of Chemical Indicator for Routine Load Release
3. Periodic Product Quality Assurance Testing
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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AAMI ST79 Reference
Biological indicators (BIs):
o
Chemical indicators (CIs):
o
Master product:
o o
Product family:
o
Notes:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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13.0 Indications for Use
13.1 SterilContainer and SterilContainer S — Steam and EtO Sterilization
13.2 SterilContainer — PreVac IUSS Sterilization
13.3 SterilContainer — JK / JN744 PreVac Steam, IUSS and EtO Sterilization
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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Validated Sterilization Cycle Parameters
Sterilization Cycle Parameters Max No. of Lumens/Lumen Configuration*
≥≤≥ ≤
≥≤≥ ≤
≥≤≥ ≤
Accessories
PreVac
Steam
PreVac
IUSS
EtO
13.4 SterilContainer with PrimeLine Lid
13.5 SterilContainer with PrimeLine Pro Lid
Aesculap® SterilContainer™ System Instructions for Use (IFU)
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As of July 2019 Page 58 of 71
Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters PrimeLine Pro
Container Lid with
JP050 – Lid Size
Solid Base to be used
with Lid
Max No. of Lumens
Lumen Configuration
Immediate Use – Non-porous
Immediate Use – porous
PreVacuum Dry Time Study
Immediate Use – Non-
Porous
Immediate Use – Porous
Prevacuum Dry Time Study
Table 2: Steam and IUSS Cycle Compatible Accessories Accessories Steam and IUSS
Stainless Steel baskets, basket lids, and dividers
Yes
Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps)
Yes
Silicone mats Yes
Stainless Steel racks, trays, holders, clamps, brackets, and platforms Yes
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 59 of 71
13.6 SterilContainer with Aluminum Lid and Metal Retention Plate — Reusable Filter
13.7 SterilContainer — JS Series
Table 1. SterilContainer S2 Validated Load Configurations
Sterilization Cycle Container Size Validated Load Configuration
≥ ≤
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 60 of 71
≥ ≤≥ ≤
≥ ≤
≥ ≤≥ ≤
≥ ≤
Table 2. SterilContainer S2 System Configurations – Prevac Steam and Gravity Steam
Sterilization Method Container Size
Container
Bottom Part #
Container
Lid Part #
Total Loaded
Container Weight*
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 61 of 71
Table 3. Sterilization Cycle Compatible Accessories - Prevac Steam and Gravity Steam
Accessories
Compatible with
Prevac Steam Gravity Steam
Table 4. SterilContainer S2 System Configurations – STERRAD Sterilization Systems
Sterilization
Method Container Size
Container
Bottom
Part #
Container
Lid Part # Total Loaded Container Weight
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 62 of 71
Table 5. Sterilization Cycle Compatible Accessories – STERRAD Sterilization Systems
Accessories
Compatible with STERRAD
100S
NX
Standard
NX
Advanced
100NX
Standard
100NX
Flex
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 63 of 71
Table 6. SterilContainer S2 System Configurations – STERIS Sterilization Systems
Sterilization
Method Container Size
Container
Bottom
Part #
Container
Lid Part # Total Loaded Container Weight
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 64 of 71
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 65 of 71
Table 7. Sterilization Cycle Compatible Accessories – STERIS Sterilization Systems
Accessories
Compatible with STERIS V-PRO
60
Lumen
60
Non-Lumen
60
Flex
maX
Lumen
maX
Non-Lumen
maX
Flex
13.8 SterilContainer S — STERRAD® 100S
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 66 of 71
13.9 SterilContainer S — STERRAD® 200 System, NX™ System, and 100NX System
≥ ≤ ≥ ≤ ≥ ≤ ≥ ≤ ≥ ≤
13.10 SterilContainer S — STERRAD 100NX EXPRESS Cycle
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 67 of 71
Container Configuration Intended Load
Accessories STERRAD 100NX Express Cycle
13.11 STERIS V-PRO 60 — SterilContainer S with Aluminum Lid
Lumen Cycle
Validated Container Load
o ≥ ≤
o ≥ ≤ ≥ ≤ ≥ ≤
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 68 of 71
Non-Lumen Cycle
Validated Container Load
Flexible Cycle
Validated Container Load
≥ ≤
Accessories V-PRO 60
13.12 STERIS V-PRO® maX Flexible Cycle — SterilContainer S with Aluminum Lid
Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations
Load Configuration 1
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 69 of 71
Load Configuration 2
V-PRO maX Sterilizer Flexible Cycle Compatible SterilContainer S Container Systems
Accessories V-PRO maX Flexible Cycle
13.13 STERIS V-PRO® 1 and V-PRO® 1 Plus— SterilContainer S with Aluminum Lid
Processing STERIS V-PRO Low Temperature Sterilization Systems Lumen and Non-Lumen Cycles
Suggested Sterilizer Cycle Parameters for SterilContainer S products:
Aesculap® SterilContainer™ System Instructions for Use (IFU)
SOP-AIC-5001592 Rev. 04 Intended for US Only
As of July 2019 Page 70 of 71
o o o
o o
Notes: