Revision Rev 03

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Aesculap® SterilContainer™ System

Instructions for Use

Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities

Instructions for Use Intended for US Only

As of February 2018

Page 3

10.2 SterilContainer System Transportation to Decontamination ............................................................................................................ 52

11.0 STERILE CONTAINER VALIDATION SUMMARY ........................................................................................................... 53

11.1 Validation Testing ........................................................................................................................................................................................... 53

11.2 Aesculap SterilContainer System and FDA Clearances ....................................................................................................................... 54

12.0

CUSTOMER VERIFICATION ............................................................................................................................................ 56

List of Figures

Figure 1: SterilContainer System................................................................................................................................................................. 4

Figure 2: Sterilizations Modality Nomenclature and SterilContainer System Compatibility ................................................... 5

Figure 3: SterilContainer Lid and Filter Options ..................................................................................................................................... 6

Figure 4: SterilContainer System Basket Options .................................................................................................................................. 7

Figure 5: Container Basket Features .......................................................................................................................................................... 7

Figure 6: PrimeLine Pro Lid Inspection Process..................................................................................................................................... 11

Figure 7: Filters for Perforated Bottoms and Lids ................................................................................................................................ 16

Figure 8: Tamper Evident Locks ................................................................................................................................................................. 19

Figure 9: Indicator and Communication Cards ..................................................................................................................................... 20

Figure 10: Easy Reference Handout ......................................................................................................................................................... 52

List of Images

Image 1: Lid Options for JK and JN Series Bottom ................................................................................................................................ 6

Image 2: Single Use Processing Supplies, Filters, Tamper Evident Locks, Indicator Cards ........................................................ 7

Image 3: JK, JN and JM Lid Reusable Filter Inspection ...................................................................................................................... 13

Image 4: Filter Retention Plates and Silicone Gaskets Inspection Process .................................................................................. 14

Image 5: PrimeLine Lid Inspection Process ............................................................................................................................................ 14

Image 6: Aluminum Lid with Metal Retention Plate and Reusable Filter .................................................................................... 17

Image 7: Aluminum Lid with Metal Retention Plate and Single Use Filer Assembly ................................................................ 17

Image 8: PrimeLine Lid Inspection Process ............................................................................................................................................ 17

Intended for US Only

As of February 2018

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

1.0

Purpose of Instructions for Use

The purpose of this document is to:



Describe the components of the SterilContainer System, how each should be used, and which components can be used

together in each of the sterile processing modalities.

Provide detailed instructions on how to use, decontaminate, clean and process the SterilContainer System properly in

different sterilization modalities.

Give guidance for verifying the SterilContainer System in your facility and application.





Instructions included in this document are based on validation testing by Aesculap in a medical device testing laboratory

using worst case scenario.

Each facility should ensure their processing system provides similar results. Personnel training and competency is required to

perform all phases of processing. Equipment, water supply, and practices all contribute to providing an effective

reprocessing system and should be monitored by the facility.

2.0

SterilContainer System

The Aesculap SterilContainer™ System is a reusable rigid container system used for the packaging, transportation, and

storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container

lid, and basket options, and should be used with Aesculap accessories such as instrument holders, baskets, filters, indicator

cards and tamper evident locks.

The first two letters of the part number are the series name, and identify the product family and attributes of each bottom

and lid. See chart. Each container bottom must ONLY be used with the specific lid designed for that series of container, and

it should not be combined with other Aesculap or non-Aesculap series of bottoms or lids.

Product Family

SterilContainer

Bottom Series

JK

Solid, Anodized

PrimeLine PrimeLine Pro

Lid Series3

JK

PreVac Steam

X

X

X

PreVac IUSS

X

X

X

Gravity

EtO

X

JK

X

SterilContainer S

JN

Perforated, Anodized

PrimeLine PrimeLine Pro

X

JM

Perforated, Non-Anodized

JM

X

X

X

X

X

Low Temp STERRAD1

2

Low Temp STERIS

1.

2.

3.

X

X

X

See section 8.0 SterilContainer S Sterilizer Cycle Parameters — ASP STERRAD® for more details on sterilizer cycle details.

See 9.0 SterilContainer S Sterilizer Cycle Parameters — STERIS® V-PRO® for more details on sterilizer cycle details.

JK, JN, JM and PrimeLine Pro lids are made of aluminum. PrimeLine is made of High-Grade, Thermostable Plastic.

Figure 1: SterilContainer System

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

Aesculap has performed the required validation tests, including accepted aerosol testing methodology for medical devices,

and received FDA clearance for its sterile container products when used in the following sterilizations modalities. The

modalities for each container series vary. Please refer to Sections 7.0 (Steam and EtO), 8.0 (STERRAD) and 9.0 (STERIS) Cycle

Parameters to determine appropriate container bottom, lid, filter, lock and indicator card for sterilization cycle being used.

Primary Name

Steam Sterilization1

Ethylene Oxide

Vapor Hydrogen Peroxide

1.

2.

3.

Which Includes

Dynamic Air Removal

Terminal Steam

Dynamic Air Removal

Immediate Use

Gravity

Ethylene Oxide

Vapor Hydrogen Peroxide

May Also Be Referred to As

PreVacuum Terminal Steam, PreVac Steam1,2

PreVacuum Immediate Use, PreVac IUSS1,2

Gravity1

EtO1

Low Temperature1, H2O2, STERRAD3, STERIS3, V-PRO3

These terms will be used throughout the remainder of the Instructions for Use (IFU)

Aesculap validations for PreVac Steam can be applied to Steam Flush Pressure Pulse (SFPP) with like cycles

May also be generically referred to by the sterilizers that use Vapor Hydrogen Peroxide — STERRAD®, STERIS® and/or (STERIS) V-PRO®

Figure 2: Sterilizations Modality Nomenclature and SterilContainer System Compatibility

The SterilContainer System is designed to be processed on a daily basis and provide years of continual use. When selecting a

container system, make sure the container and instruments match the application and sterilization requirements properly.

AAMI ST79 Annexes on the “Development of a Pre-purchase Evaluation Protocol for Rigid Sterilization Container Systems”,

provides guidelines on how to conduct an evaluation.

Notes:









Throughout this IFU document, references to the SterilContainer System include the SterilContainer and the

SterilContainer S product families. References to the SterilContainer only include the JK / JN Series of products and

references to SterilContainer S only include JM Series of products.

Each facility should ensure its processing system provides similar results. Personnel training and competency is

required to perform all phases of manual processing. Equipment, water supply, and practices all contribute to

providing an effective reprocessing system and should be monitored by the facility.

Also visit www.youtube.com/aesculapusa SterilContainer System section for informational videos on SterilContainer

System proper sterile reprocessing preparation.

See AAMI ST79 section on “Sterilization Parameters for Wrapped or Containerized Items” for more details and

recommendations.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

2.1 SterilContainer System Lids

The SterilContainer System full, three-quarter and half size JK Series and JN Series have three lid options.

JP Series PrimeLine Pro

JK Series Aluminum Lids

with Metal Retention Plate

JP Series PrimeLine

Image 1: Lid Options for JK and JN Series Bottom

The PrimeLine and PrimeLine Pro offer unique benefits.

 Integrated reusable PTFE filter designed for 2,200 sterilization cycles

 Reusable filter saves time and reduces processing costs

JK

PrimeLine1

JP

PrimeLine Pro1

JP

JK, JN

JK, JN

JK, JN

Lid Material

Aluminum,

Anodized

Surface

Aluminum,

Anodized

Surface

Lid Color

Red, Blue,

Green, Gold,

Silver2

High-Grade,

Thermostable

Plastic

Red, Blue,

Green, Orange,

Gray, Anthracite,

Clear

Lid Series

Container Bottom

Series

Filter Options3

Single,

Reusable

Reusable4

JE

Wide-Body

JK, JN

Aluminum,

Anodized

Surface

JM

Aluminum,

Non-Anodized

Surface

Red, Blue,

Green, Gold,

Silver2

Silver

Silver

Reusable4

Single,

Reusable4

Single,

Reusable4

JM

1. PrimeLine and PrimeLine Pro lids are only available for JK and JN Series full-size, three-quarter size and half size containers.

2. Color lid options are only available for full-size, three-quarter size, half size and mini-size containers. See Aesculap product catalog.

3. See 6.0 Preparation and Assembly of SterilContainer System for filter modality compatibility.

4. Polytetrafluoroethylene (PTFE) filter.

Figure 3: SterilContainer Lid and Filter Options

Notes:









Silicone gasket in lid and filter retention plate are latex free.

The Aesculap reusable PTFE filters have been validated and are FDA cleared for PreVac Terminal Steam and PreVac

Immediate Use Steam Sterilization (IUSS) for up to 2,200 cycles (inspect – decontaminate – wash – assemble –

sterilize – store – use).

Using JK086 marking pen, record the date put into service and the estimated remove from service date, in mm/dd/yy

format. Calculate the remove from service date based on the average expected reprocessing levels for your facility.

Do not exceed 2,200 cycles.

Aesculap SterilContainer System has been validated ONLY with Aesculap reusable filters.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

SterilContainer System Processing Supplies include single use paper and polypropylene filters, tamper evident locks

and indicator cards. See Section 6.0 Preparation and Assembly of SterilContainer System for more information and for

filter modality compatibility.

Image 2: Single Use Processing Supplies, Filters, Tamper Evident Locks, Indicator Cards

2.2 SterilContainer System Baskets

The SterilContainer System Baskets are made of stainless steel. Baskets are available with and without covers

depending on the size.

Stainless Steel Honeycomb Baskets,

Stainless Steel Standard Basket

with Rounded Corner, JB Series

with Cut Corners, JF Series

Figure 4: SterilContainer System Basket Options

The first two letters of the part number are the basket series name, and help identify the container product family and

attributes of each basket.

Basket Series

Container Series

Perforation Pattern1

Corner Shape1

Basket Cover Available1

Feet on Basket1

1.

JB

JC

JK, JN, JM

JK, JN, JM

Honeycomb

Rounded

Honeycomb

Rounded

X

JE

Wide-Body

JK, JN

Wire Mash

Rounded

JF

JK, JN, JM

Standard

Cut Corner

X

X

Information listed pertains to full-size, three-quarter size and half size baskets. quarter-size, mini-size, extra-long size and other

baskets may have different basket configuration. Contact Aesculap sales representative or customer service for more details.

Figure 5: Container Basket Features

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

2.3 SterilContainer System Accessories

SterilContainer System accessories include the following:











Identification labels or tags

Mats

Instrument organization system (IOS)

Racks and scope holding platform

Instrument stringers

Contact Aesculap sales representative or customer service for more details on accessories.

Notes:









3.0

Aesculap baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using

the same processes as Aesculap sterile container bottoms.

Aesculap IOS pieces (IOS Mounting Type B & C) and mats are made of silicone and cutting them does not change the

characteristics of the material and/or its function.

Aesculap SterilContainer System only performs container testing with baskets and does not recommend using

containers without baskets or with only mats. The only exception is the JK187 and JN187 because of their size and

height, a mat only is acceptable.

Aesculap JF598 and JG600 are non-silicone lubricants and do not require any additional PPE during use. The drops

and the spray can be used interchangeably unless specified by an instrument manufacturers’ IFU. The drops will

provide more precise application in small area. When applying oil, a reasonable amount should be used. For the drops

this would be one or two drops, and for the spray it would be a light even coating of the area that requires

lubrication. Excess oil should be removed with a clear lint-free cloth after proper application. The oil should not

cause build up when excess oil is removed and the instrument is cleaned properly.

SterilContainer System Repairs

Like all reusable medical devices, the SterilContainer System requires proper care and handling.

The Aesculap SterilContainer System is a FDA Class II device that requires extensive testing and FDA 510(k) clearance. An

Aesculap trained technician can repair containers to the original equipment manufacturer dimensions and specifications of

the original containers used in the validation and replace parts such as gaskets, filter systems and handles with the same

Aesculap components.

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.

Aesculap offers a wide variety of container repair programs that can be performed by either our highly trained technicians at

our central repair facility in St. Louis, or by our mobile van repair specialists. All of the repair specialists are Aesculap

employees who go through extensive training on Aesculap products.

Contact an Aesculap representative or call customer service (1-800-214-3392 or atscsr.us@aesculap.com) for more details.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

Notes:





All products being returned for maintenance/repair must be thoroughly cleaned and decontaminated before service.

Retention plates should be replaced when they show wear, age and/or are damaged. The retention plate on the metal

lids should not spin freely when properly installed and in proper working condition. Note that the retention plate may

move a little if significant amount of pressure is applied while trying to twist or turn (especially when filter is

installed).

4.0

Decontamination and Cleaning Process

Follow facility’s policies, procedures, and AAMI ST79 recommended guidelines for the transportation of soiled instruments

and containers. Always wear appropriate personal protective equipment (PPE) per the healthcare facility’s policy and

procedures when transporting and cleaning the SterilContainer System.

DO NOT USE abrasive cleaners, metal brushes or abrasive cleaning pads. Use of abrasive products can cause permanent

damage to container surfaces. Use of abrasive cleaners or pads will result in warranty exclusion.

If container and/or lid are soiled, they must be fully cleaned. For containers and/or lids that are not soiled and have been

removed from the operating room before the patient entered, the facility should determine best cleaning practice based on

its established policy and procedures.

Container, lids and baskets that may not be used or needed right away should be decontaminated and cleaned prior to

storage. The SterilContainer System should be stacked neatly, either assembled or unassembled, in a dry, clean area.

Notes:











Thoroughly clean all Aesculap container products, baskets, accessories and replacement parts prior to first use and

after container repair service has been performed.

Cleaning wipes with pH range of 6.5 to 8.5 that do not contain chlorides will not harm the aluminum surface but the

effectiveness of wipes in cleaning the container system has not been evaluated by Aesculap. The use of wipes should

be determined based on established facility policy and procedures. See cleaning wipe manufacturer Instructions for

Use and AAMI ST79. Aesculap has no validation testing for the use of wipes in the decontamination and cleaning

process.

Remove container bottom and JK Series and JM Series aluminum lid retention plate(s) by pushing inward

simultaneously on the two buttons on the center section of the retention plate.

To replace container bottom and JK Series and JM Series aluminum lid retention plate(s), press down evenly on

retention plate. Listen to audible “click” to confirm filter is locked in place.

Aesculap baskets may be processed in an ultrasonic cleaner. Aesculap has not evaluated the use of SterilContainer

bottoms and lids in ultrasonic cleaners.

4.1 Water Quality

Water quality is an important consideration in all stages of medical device reprocessing and can contribute to

providing an effective reprocessing system and should be monitored by the facility. AAMI TIR34:2014 outlines the

different types of water and the specific use of each.

4.1.1 Utility Water

Utility water, per AAMI TIR34, is water as it comes from the tap that might require further treatment to achieve the

specifications. See AAMI TIR34 for specifications table. This water is mainly used for flushing, washing, and rinsing.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

4.1.2 Critical Water

Critical water, per AAMI TIR34, is water that is extensively treated (usually by a multistep treatment process that

could include a carbon bed, softening, DI, and RO or distillation) to ensure that the microorganisms and the

inorganic and organic material are removed from the water; a final submicron filtration could also be part of the

treatment process. This water is recommended for the final rinse and steam generation to avoid discoloration or

damage resulting from minerals found in utility water.

4.2 Detergent Solutions

Use detergent in a water solution where the detergent and water have a pH range of 6.5 to 8.5 to clean effectively

and without causing damage to the SterilContainer or SterilContainer S containers.

Notes:

 The use of utility water in mechanical washers may result in the water having a high alkaline level which could be

harmful to the container surface. Critical water should be used for the final rinse.

 If white residue is observed on the container, this may have been caused by a high pH, alkaline, cleaning solution.

Check pH level of water and detergent solution throughout the process—reduce to a pH of 6.5 to 8.5. The white residue

does not impact form, fit or function.

 DO NOT USE solvents such as acetone or benzene, which may be found in chemical drying rinses on the PrimeLine and

PrimeLine Pro Lids. Use of these products can cause permanent damage to lid surfaces and/or filter housing, and result

in warranty exclusion.

4.3 Decontamination and Mechanical Cleaning

1.

2.

3.

4.

Remove all remaining external process indicators and disposable locks.

Remove lid from bottom of container.

Remove the basket and any instruments from the container.

Single Use Filter

a. Remove retention plate(s).

b. Remove single use filter(s) and discard (if present).

c. Rinse visible debris from retention plate(s).

d. The metal retention plate may be washed separately or installed during mechanical washing.

5. Reusable Filter

a. Remove retention plate while leaving filter in place.

b. Rinse visible debris from retention plate(s).

c. Do not discard reusable filter if in good working condition and within recorded date. Reusable filter may

remain held in place by the retention plate during cleaning provided there is no visible sign of wear,

damage and/or bioburden. The PTFE filter material is hydrophobic so blood and other liquids can be rinsed

off the filter if bioburden is observed.

d. Replace retention plate(s)

6. Rinse visible debris from all container components.

a. Critical water is recommended for the final rinse and steam generation to avoid discoloration or damage

resulting from minerals found in utility water.

b. For PrimeLine and PrimeLine Pro - Exclusively use critical water for the final rinse and make sure no

residues from the cleaning process remain on the lid.

7. Place components on washer rack facing down to avoid water collection.

a. Fold the lid handles towards the inside of the lid to avoid water collection and damage.

b. Retention plates should face away from the direct force of pressurized washer jets to avoid damage

during wash cycles.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

8. After mechanical cleaning cycle

a. Thoroughly dry (either with a soft, dry cloth or air dry) all components, and retention plate and retention

plate housing (PrimeLine and PrimeLine Pro) before proceeding to preparation and packaging.

b. If retention plates were installed during mechanical washing, remove retention plate(s) and dry area

between retention plate and container.

(From Aesculap Doc1006)

Remove filter retention plate

by turning counter clockwise.

Retention plate should be

free of cracks and damage.

Reusable filter may remain inside lid

during inspection. Check filter integrity

for rips/tears. Retention plates may be

installed during mechanical washing.

Figure 6: PrimeLine Pro Lid Inspection Process

Notes:

 After cleaning visually inspect and repeat the cleaning process if a visually clean endpoint has not been achieved.

 DO NOT USE solvents such as acetone or benzene, which may be found in chemical drying rinses on the PrimeLine and

PrimeLine Pro lids. Use of these products can cause permanent damage to lid surfaces and/or filter housing, and result

in warranty exclusion.

 The integrated filter system, and the decontamination, cleaning, inspection and aseptic presentation process are the

same for PrimeLine and PrimeLine Pro.

 To remove sterilization adhesive tape remnant of surface abrasions, we recommend the use of Aesculap-Eloxal Cleaner

(Catalog number JG601). This is a non-abrasive cleaner. Apply the cream, the size of penny with a soft dry, non-linting

cloth and rub to polish the surface. If needed, repeat with an increasing volume. Thoroughly remove all residual

cleaning cream. Critical water is recommended for the final rinse. Cleaner may cause discoloration and/or fading of

colored surfaces. DO NOT USE cleaner on PrimeLine lid, and PrimeLine Pro lid filter housing and stainless steel covers.

4.4 Decontamination and Manual Cleaning

Each facility should ensure their processing system provides similar results. Personnel training and competency is

required to perform all phases of manual processing. Equipment, water supply, and practices all contribute to

providing an effective reprocessing system and should be monitored by the facility.

1.

2.

3.

4.

Remove all remaining external process indicators and disposable locks.

Remove lid from bottom of container.

Remove the basket and any instruments from the container.

Single Use Filter

a. Remove retention plate(s).

b. Remove single use filter(s) and discard (if present).

c. Rinse visible debris from retention plate(s).

d. The retention plate should be washed separately.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

5. Reusable Filter

a. Remove retention plate while leaving filter in place.

b. Rinse visible debris from retention plate(s).

c. Do not discard reusable filter if in good working condition and within recorded date. Reusable filter may

remain held in place by the retention plate during cleaning provided there is no visible sign of wear,

damage and/or bioburden. The PTFE filter material is hydrophobic so blood and other liquids can be rinsed

off the filter if bioburden is observed.

d. Replace retention plate(s)

6. Rinse visible debris from all container components.

a. Critical water is recommended for the final rinse and steam generation to avoid discoloration or damage

resulting from minerals found in utility water.

b. For PrimeLine and PrimeLine Pro - Exclusively use critical water for the final rinse and make sure no

residues from the cleaning process remain on the lid.

7. Use a soft sponge and detergent, as described in Section 4.2 Detergent Solutions, to clean the components of the

SterilContainer.

8. After manually cleaning

a. Thoroughly dry (either with a soft, dry cloth or air dry) all components, and retention plate and retention

plate housing (PrimeLine and PrimeLine Pro) before proceeding to preparation and packaging.

b. If retention plates were installed during washing, remove retention plate(s) and dry area between

retention plate and container.

Notes:

 After cleaning visually inspect and repeat the cleaning process if a visually clean endpoint has not been achieved.

 If container and/or lid are soiled, they must be fully cleaned. For containers and/or lids that are not soiled and have

been removed from the operating room before the patient entered, the facility should determine best cleaning practice

based on its established policy and procedures.

 Cleaning wipes with pH range of 6.5 to 8.5 that do not contain chlorides will not harm the aluminum surface but the

effectiveness of wipes in cleaning the container system has not been evaluated by Aesculap. The use of wipes should

be determined based on established facility policy and procedures. See cleaning wipe manufacturer Instructions for

Use and AAMI ST79. Aesculap has no validation testing for the use of wipes in the decontamination and cleaning

process.

 DO NOT USE Alcohol wipes – alcohol will harm the PrimeLine lid or PrimeLine Pro filter housing.

 If components are too large to be immersed at the facility, then the components should be cleaned in a manner that

will not produce aerosols. Please refer to AAMI ST79 for recommended practices.

 To remove sterilization adhesive tape remnant of surface abrasions, we recommend the use of Aesculap-Eloxal Cleaner

(Catalog number JG601). This is a non-abrasive cleaner. Apply the cream, the size of penny with a soft dry, non-linting

cloth and rub to polish the surface. If needed, repeat with an increasing volume. Thoroughly remove all residual

cleaning cream. Critical water is recommended for the final rinse. Cleaner may cause discoloration and/or fading of

colored surfaces. DO NOT USE cleaner on PrimeLine lid, and PrimeLine Pro lid filter housing and stainless steel covers.

 DO NOT USE solvents such as acetone or benzene, which may be found in chemical drying rinses on the PrimeLine and

PrimeLine Pro Lids. Use of these products can cause permanent damage to lid surfaces and/or filter housing, and result

in warranty exclusion.

 The integrated filter system, and the decontamination, cleaning, inspection and aseptic presentation process are the

same for PrimeLine and PrimeLine Pro.

 Aesculap baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using

the same processes as Aesculap sterile container bottoms.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

5.0

Inspection Prior to Use

Inspection of the container and its components must be conducted PRIOR TO EVERY USE.

If any of the conditions described in this section are observed DO NOT USE the SterilContainer or SterilContainer S container

bottom and/or lid. Contact Aesculap for repair services. 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. See

Section 3.0 SterilContainer System Repairs for full details regarding repairs.

Please refer to Sections 7.0 (Steam and EtO), 8.0 (STERRAD), 9.0 (STERIS) Cycle Parameters to determine appropriate

container bottom, lid, filter, lock and indicator card for sterilization cycle being used.

Notes:









After cleaning, and before use, visually inspect and repeat the cleaning process if a visually clean endpoint has not

been achieved.

Remove container bottom and JK Series and JM Series aluminum lid retention plate(s) by pushing inward

simultaneously on the two buttons on the center section of the retention plate.

To replace container bottom and JK Series and JM Series aluminum lid retention plate(s), press down evenly on

retention plate. Listen to audible “click” to confirm filter is locked in place.

The metal retention plate may be washed separately or installed during mechanical washing. Retention plates should

face away from the direct force of pressurized washer jets to avoid damage during wash cycles.

5.1 SterilContainer System Inspection Criteria

1. All container components should be inspected and free from

a. Observable cracking in aluminum and/or plastic.

b. Any misalignment and/or dents in which the lid and bottoms do not adequately mate.

c. Any pitting in the aluminum.

2. Lid silicone gasket should be inspected and free from any sign cracking or damage.

3. For metal retention plates.

a. Remove retention plate by pressing in on the two tabs and lifting.

For reusable filter, leave filter in place during inspection.

Reusable filter may remain in place inside lid during inspection. Check filter integrity for damage.

The retention plate may be installed during mechanical washing.

Image 3: JK, JN and JM Lid Reusable Filter Inspection

b. Metal filter retention plate and silicone gasket should be inspected and free from:

i. Any sign of cracking or damage.

ii. Any misalignment or damage in which retention pin, filter, retention plate and/or gasket do not

adequately mate.

c. Confirm retention plate is not bent by placing retention plate on flat surface to check for continuous

contact around edge. Note that when performing the inspection, there will be a uniform space between

the outer most edge of the retention plate and the surface since the retention plate has a raised gasket

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

(From Aesculap Doc1006)

Remove filter retention plate by pressing

in on the two tabs and lifting.

Place retention plate on flat surface to

check for continuous contact around

edge. Retention plate gasket should be

free of cracks or damage.

Pin for filter retention plate must be

secure and firm. The retention plate may

be installed during mechanical washing.

Image 4: Filter Retention Plates and Silicone Gaskets Inspection Process

d. Confirm filter retention pin is secure and firm.

e. Confirm filter retention plate is secure and firm on retention pin.

f. Remove retention plate from service if it does not meet criteria above, and replace with Aesculap part

number JK100 round, JK098 rectangle.

4. For PrimeLine and PrimeLine Pro retention plates.

(From Aesculap Doc1006)

Remove filter retention plate by turning

counter clockwise.

Retention plates should be free

of cracks and damage.

Reusable filter may remain inside lid

during inspection. Check filter integrity

for rips/tears. Check that filter is within

use-by date. Retention plate may be

installed during mechanical washing.

Image 5: PrimeLine Lid Inspection Process

a. Remove retention plate by turning counter clockwise. Leaving filter in place.

b. Inspect reusable filter for holes, tears and rips. If observed, remove filter from service and replace with

Aesculap part number JP050.

c. Confirm filter is within use-by date (<2,200 cycles). Replace as needed.

d. Filter retention plate(s) and filter housing(s) should be inspected and free from:

i. Any sign of cracking or damage.

ii. Any misalignment or damage in which retention plate, filter and/or filter housing do not

adequately mate.

e. Confirm filter, retention plate and filter housing are secure and firm.

f. Remove retention plate from service if it does not meet criteria above, and replace with Aesculap part

number JP001204.

g. Replace retention plate by turning clockwise.

5. For PrimeLine lid

a. Confirm black outside filter cover secure and firm.

b. Remove cover from service if it does not meet criteria above, and replace with Aesculap part

number JP001202.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

Notes:

















If white residue is observed on the container, this may have been caused by a high pH, alkaline, cleaning solution.

Check pH level of water and detergent solution throughout the process—reduce to a pH of 6.5 to 8.5. The white

residue does not impact form, fit or function.

The SterilContainer S is made of non-anodized aluminum which undergoes a natural oxidation process. This

oxidation process produces a very thin layer on the surface which may appear brown or black. This oxidation process

will continue until the entire raw surface is oxidized. This brown or black discoloration is part of the natural

processes. Please contact an Aesculap representative for more information, if needed.

Retention plates should be replaced when they show wear, age and/or are damaged. The retention plate on the metal

lids should not spin freely when properly installed and in proper working condition. Note that the retention plate may

move a little if significant amount of pressure is applied while trying to twist or turn (especially when filter is

installed).

Excessive removal and replacement of reusable filter over center pin may cause tearing of the center hole.

Metal retention plate may be washed separately or installed during mechanical washing. Retention plates should

face away from the direct force of pressurized washer jets to avoid damage during wash cycles.

Using inspection and test methods other than those outlined in this IFU are not recommended and have not been

validated by Aesculap.

The integrated filter system, and the decontamination, cleaning, inspection and aseptic presentation process are the

same for PrimeLine and PrimeLine Pro.

If the PrimeLine or PrimeLine Pro outside dustcover (indicated by the white

arrow in the picture) falls off after sterilization and before the set is used,

the set can maintain sterility if no other event related incidence has

occurred since it is a sealed filter system. The broken dustcover should be

replaced and/or the lid should be serviced by Aesculap. See Section 3.0

SterilContainer System Repairs for full details regarding repairs.

5.2 Basket, Tray and Accessory Inspection Criteria

Baskets, lifting platforms and trays should be inspected and free from:

1. Observable cracking and/or dents

2. Any misalignment of sides, bottom or handles

3. Any loose or worn handles, parts, accessories or instrument organization system components

Aesculap baskets and accessories can be cleaned and sterilized following the same processes as Aesculap sterile

container bottoms, and accepted industry guidelines.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

6.0

Preparation and Assembly of SterilContainer System

Inspection of the container and its components must be conducted PRIOR TO EVERY USE. Please refer to Section 5.0

Inspection Prior to Use to learn how to properly inspect a container and its components. Ensure all container components are

completely dry.

Each container bottom must ONLY be used with the specific lid designed for that series of container, and it should not be

combined with other Aesculap or non-Aesculap series of bottoms or lids.

Determine the type of SterilContainer bottom and lid being assembled and proceed to that section. Please refer to Sections

7.0 (Steam and EtO), 8.0 (STERRAD), 9.0 (STERIS) Cycle Parameters to determine appropriate container bottom, lid, filter, lock

and indicator card for sterilization cycle being used.

Filter Type

Paper Filter

w/ Indicator1

PreVac Steam

PreVac IUSS

Gravity

EtO

X1

X1

X1

X1

X

X

X

X

X

X

X

X

X

X

Low Temp

US751

Paper Filter

w/o Indicator

US994, US999

Polypropylene Filter

w/o Indicator

X

X

MD344, MD355

Metal Retention Plate Lid

PTFE Reusable Filter

JK090, JK091

PrimeLine & PrimeLine Pro

PTFE Reusable Filter2

JP050

1.

Filter contains a dual indicator dot, which changes from blue to brown in steam, and to orange in EtO.

Figure 7: Filters for Perforated Bottoms and Lids

Notes:





Also visit www.youtube.com/aesculapusa SterilContainer System section for informational videos on SterilContainer

System proper sterile reprocessing preparation.

All information and steps outlined in this IFU should be followed. Aesculap DOC1006 and DOC1007 may be used as a

reference guide in Prep and Pack, and the OR respectively once personnel training and competency is achieved.

6.1 SterilContainer System Assembly

1. ONLY USE containers and components that have passed the inspection criteria outlined in Section 5.0 Inspection

Prior to Use.

2. Please refer to Sections 7.0 (Steam and EtO), 8.0 (STERRAD), 9.0 (STERIS) Cycle Parameters based on container

system for proper filter selection

3. For metal retention plates.

Remove retention plate by pushing inward on the two buttons on the side of the center section of the retention

plate.

a. For single use filters.

Place one sheet of the appropriate Aesculap single use filter over each perforated section on the inside of

the container lid and if used, the perforated bottom.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

b. For reusable filters.

Leave filter in place during inspection.

Reusable filter may remain in place inside lid during inspection. Check filter integrity for damage.

The retention plate may be installed during mechanical washing.

Image 6: Aluminum Lid with Metal Retention Plate and Reusable Filter

c.

Confirm the filter is laying flat, and secure each filter with the retention plate.

Listen to audible “click” to confirm filter is locked in place.

Confirm the filter is laying flat, and secure each filter with the retention plate.

Listen to audible “click” to confirm filter is locked in place.

Image 7: Aluminum Lid with Metal Retention Plate and Single Use Filer Assembly

4. For PrimeLine and PrimeLine Pro retention plates.

(From Aesculap Doc1006)

Remove filter retention plate by turning

counter clockwise.

Retention plate should be free

of cracks and damage.

Reusable filter may remain inside lid

during inspection. Check filter integrity

for rips/tears. Check that filter is within

use-by date. Retention plate may be

installed during mechanical washing.

Image 8: PrimeLine Lid Inspection Process

a. Remove retention plate by turning counter clockwise. Leaving filter in place.

b. Inspect reusable filter for holes, tears and rips. If observed, remove filter from service and replace with

Aesculap part number JP050.

c. Confirm filter is within use-by date (<2,200 cycles). Replace as needed.

d. Replace retention plate by turning clockwise.

Intended for US Only

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

Notes:

 The orientation of the paper filter with indicator can be placed in either orientation, indicator dot facing in or out of

the retention plate. Facility should determine orientation based on its established policy and procedures.

 Single use paper filters are not compatible with Low Temperature sterilizers.

 Aesculap only used one filter under each retention plate during our validation testing. If multiple filters are placed

under retention plate accidentally we recommend that the set be rejected and be reprocessed.

6.2 Assembly of Surgical Instrumentation

Instruments and all components of the SterilContainer System must be completely dry prior to sterilization processing

to allow for adequate sterilant penetration. Sort and assemble thoroughly cleaned and dried instruments into the

instrument basket(s), according to established hospital procedures. Follow instrument manufacturers’ Instructions for

Use.

Aesculap has a wide array of identification tags and write-on labels to help identify instruments and instrument sets

that require an action, such as: repair, broken, pull for service, quick turnover, discard and loaner. See your Aesculap

sales representative from more details.

6.3 Loading of Basket, Lifting Platform and Tray

Please refer to Sections 7.0 (Steam and EtO), 8.0 (STERRAD), 9.0 (STERIS) Cycle Parameters to determine maximum

weight of SterilContainer System for sterilization modality selected.

1. Place assembled instrument basket(s), lifting platform or support racks into the prepared container bottom.

2. Place assembled lid onto the container bottom, aligning handles on bottom with latches on lid.

3. Simultaneously close both locking latches on the container lid.

Aesculap baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using

the same processes as Aesculap sterile container bottoms.

Notes:

 All instruments should be arranged per the instrument manufacturers’ Instructions for Use (IFU).

 Hospitals should refer to AAMI and accepted industry guidelines, and sterilization manufacturers’ Instructions for Use

(IFU) regarding weights and weight limits.

 Hospitals should reconcile the Aesculap SterilContainer System, instrument manufacturers’ and sterilization

manufacturers’ Instructions for Use (IFU) regarding sterilization parameters, set configurations and weight limit.

 Trays and baskets may be stacked inside the SterilContainer System if clearance requirements (below) are met and the

set follows proper acetic presentation guidelines.

 Full-Size, Three-Quarter Size, Half-Size Wide-Body, Extra-Long Container — Leave one inch of free space

between the instruments and the rim of the container for effective processing. Basket handles may encroach into this

clearance space as long as they do not interfere with the lid’s filter retention plate or lid closure.

 Extra-Long Mini-Size Container — Instruments and baskets can be loaded to the rim of the container as long as they

do not interfere with the lid’s filter retention plate or lid closure.

 Mini-Size and Quarter-Size Container — Leave one quarter of an inch of free space between the instruments and

the rim of the container for effective processing. Basket handles may encroach into this clearance space as long as

they do not interfere with the lid’s filter retention plate or lid closure.

 The SterilContainer System PreVac Steam validation studies were performed with a silicone mat and non-linting

surgical towel placed in the tray under the instruments as part of the “worst case” validation. Per ANSI/AAMI ST79

"Non-linting absorbent material may be placed in the tray to facilitate drying…It is important that the absorbent

material be non-linting because lint can carry microorganisms into the surgical site as well as cause foreign-body

reactions.”

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

6.4 Internal Process Indicators

Per AAMI ST79, internal process indicators are used to indicate that the container has been exposed to the

sterilization process. If more than one basket/tray is used inside the container system, an indicator should be placed

on each basket/tray.

The internal biological and/or chemical indicators may be placed in the center of each tray, unless the user feels a

more challenging position exists elsewhere. In that case, place the chemical indicator where the user has determined

the most challenging location. Use of internal indicators should be in accordance with the facility’s policies and

procedures.

Process indicators are designed to indicate that the device was exposed to the sterilization process while, integrating

indicators are designed to react to all critical variables, with the stated values having been generated to be equivalent

to, or exceed, the performance requirements given in the ISO 11138 series for BIs. See AAMI ST79 for full description

and use of each type of chemical indicator.

Notes:

 See Section 12.0 Customer Verification for information on chemical and biologic indicator placement and on how to

perform a verification.

 Aesculap does not validate containers with paper count sheets containing ink. Users to process count sheets according

to their facility’s protocol.

6.5 External Process Indicators and Tamper Evident Seals

Per AAMI ST79, external process indicators are used to indicate that the container has been exposed to the

sterilization process and to distinguish between processed and unprocessed containers. Use of external indicators

should be in accordance with the facility’s policies and procedures.

Please refer to Sections 7.0 (Steam and EtO), 8.0 (STERRAD), 9.0 (STERIS) Cycle Parameters to determine appropriate

container bottom, lid, filter, lock and indicator card for sterilization cycle being used.

1. If desired, select the appropriate Aesculap Indicator Card and insert into the holding bracket on the outside of

the container. A tab at one end of the indicator card will facilitate insertion and removal.

2. Insert the appropriate tamper evident lock into the locking channel on each end.

3. Secure and close the tamper evident lock.

Tamper Evident Locks

Blue / US900

No Indicator

PreVac Steam

PreVac IUSS

Gravity

EtO

Low Temp

X

X

X

X

X

Green / US905

X

Change1 Yellow to Orange

Orange / US906

Change1 Blue to Brown

X

X

Pink / US9102

X2

Change1 Magenta to Blue

Yellow / US399

Change1 Blue to Brown

1.

2.

X

X

After sterilization, the external indicator should change from the original indicator color to the recommended post sterilization

indicator color. 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.

Locks must be stored in a controlled room temperature, away from alkaline chemicals, acids and sources of light.

Figure 8: Tamper Evident Locks

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

Indicator &

Communication Cards

MD334, MD335

w/ Indicator

PreVac Steam

PreVac IUSS

Gravity

EtO

Low Temp

X

Change1 Blue

MD346, MD876, US754

w/ Indicator

Change1,2 Brown in Steam

Change1,2 Orange in EtO

US963

w/o Indicator

MD399, MD345

w/ Indicator

X

X

X

X

X

X

X

X

X

X

1

Change Brown

1. After sterilization, the external indicator should change from the original indicator color to the recommended post sterilization indicator

color. 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.

2. Filter contains a dual indicator dot, which changes to brown in steam, and to orange in EtO.

Figure 9: Indicator and Communication Cards

Notes:

 The Aesculap tamper evident locks with indicator and/or process indicator card may be used as external process

indicators. See the outside product packaging label for care and handling information.

 After sterilization, the external indicator should change from the original indicator color to the recommended post

sterilization indicator color. 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.

 Tamper Evident Locks US900, US905, US906 and US399 — Store in a cool, dry place. Temperatures between 15°

C/60° F and 30° C/86° F should be maintained. Significant changes in storage conditions for prolonged periods can

have an adverse effect on the product. (Minor variations over short periods of time will have little or no effect on

product.) Extreme storage conditions such as exposure to direct sunlight and/or storage on top of or near heat source

should be avoided. DO NOT USE if the indicator dot color has changed before being processed.

 Tamper Evident Lock US910 — Low Temperature external Chemical Indicators (CIs) are particularly sensitive and

must be stored in a controlled room temperature, away from alkaline chemicals, acids and sources of light prior to use.

DO NOT USE beyond the expiration date provided on the outside product packaging. Change of color prior to use in

the sterilizer could indicate that these CIs were exposed to too much light or high temperatures during storage. After

being processed, low temperature tamper evident lock should be stored at a controlled room temperature away from

alkaline chemicals, acids and sources of light.

 Indicator & Communication Cards MD334, MD335 —Store in original packaging until needed. Store unused

indicators in controlled room temperature, away from any alkaline chemicals, acids and sources of light. DO NOT USE

beyond the expiration date provided on the outside product packaging.

 Indicator & Communication Cards MD346, MD876, US754, MD399 — Store in dry cool place.

6.6 Container Storage

The Aesculap rigid SterilContainer System is stackable. After sterilization, containers should be stored in a manner that

reduces the potential for contamination, see AAMI ST79 and ASHRAE guidelines for further details. DO NOT stack

more than three, 25 lbs each, containers high. Follow shelf manufacturer weight and height limit recommendations

when stacking the containers during sterile storage.

Store processed SterilContainer Systems in a dry, clean and protected place. The loss of sterility is normally eventrelated and not time-related. Loss of sterility is not so much connected to the storage periods as to outside influences

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

and the effects of storage, transportation, and handling. Therefore, blanket statements cannot be made regarding

appropriate storage periods, see EN ISO 11607-1, ANSI/AAMI ST79 and DIN 58953-8. Facilities should establish

processes and procedures related to storage and shelf life.

The storage period of the SterilContainer System has been investigated in various long-term studies. The preservation

of sterility was demonstrated over this entire period. The storage conditions used in the tests met the requirements of

ANSI/AAMI ST79 and ASHRAE.

7.0

SterilContainer System Sterilizer Cycle Parameters — Steam and EtO

This section provides detailed charts that identify the SterilContainer System configurations, locks, indicator cards and

filter(s), which should be used together for Steam and EtO modalities.

Aesculap has performed validation testing that support the configurations shown. These configurations are supported by the

numerous FDA 510(k) clearances held by Aesculap. Configuring the SterilContainer System in a manner not shown in the

tables constitutes an off label use of the product.

In the event the instrument IFU does not match the SterilContainer System IFU, the instrument IFU should take precedence.

See AAMI ST79 for information on how to reconcile multiple IFUs.

See Section 2.0 SterilContainer System for an explanation of the SterilContainer System.

7.1 Steam and EtO Sterilization Modality Cycle Parameters

Primary Name

Steam Sterilization1

Ethylene Oxide

1.

2.

Which Includes

Dynamic Air Removal

Terminal Steam

Dynamic Air Removal

Immediate Use

Gravity

Ethylene Oxide

May Also Be Referred to As

PreVacuum Terminal Steam, PreVac Steam1,2

PreVacuum Immediate Use, PreVac IUSS1,2

Gravity1

EtO1

These terms will be used throughout the remainder of the Instructions for Use (IFU).

Aesculap validations for PreVac Steam may be applied to Steam Flush Pressure Pulse (SFPP) with like cycles.

7.1.1 PreVac Steam Sterilization Cycle Parameters (1)





Exposure Time: 270° F for 4 minutes

Dry Time: 15 minutes

Dry times may be longer in practice depending on sterilization load density, quantity of instruments, or material of

instruments.

7.1.2 PreVac IUSS Sterilization Cycle Parameters (2)

ONLY Aesculap JK Series solid bottom containers can be used for PreVac IUSS.

Porous Instruments

 Exposure Time: 270° F for 4 minutes

 Dry Time: 0 minutes

Non-Porous Instruments

 Exposure Time: 270° F for 3 minutes

 Dry Time: 0 minutes

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

7.1.3 Gravity Steam Sterilization Cycle Parameters (3)





Exposure Time: 250° for 30-60 minutes, depending on load size

Dry Time: 15 minutes

7.1.4 EtO Cycle Parameters (4)

















Temp: 125°F - 130° F

PreVac (minimum): 25" Hg

Humidity: 40-60% RH

Gas Pressure (minimum): 600 mg/L

EO Gas Mixtures may vary i.e. 10/90% by weight or 100%

Exposure Time (minimum): 60 Minutes

Post Vac (minimum): 20" Hg

Aeration (minimum): 8 Hours

7.1.5 PreVac Steam Sterilization Cycle Parameters (5)

This cycle is only for the JK744 and JN744 container.





Exposure Time: 270° F at 4 minutes

Dry Time (minimum): 30 minutes

Aesculap’s JK744 and JN744 have a 30 minute dry time because they have the lowest vent to volume ratio.

Notes:

 The numbers in parentheses after each description below correlates with the numbers in the Sterilization Modality

columns on the tables that follow.

 Max Total Weight = SterilContainer System (bottom and lid) + Baskets (including mats) + Instruments + Container

Accessories.

 For steam cycles, running a longer exposure time and/or drying time than those stated will not harm the

SterilContainer System. See instrument IFU regarding the effect on instruments.

 For steam cycles, if different times or temperatures are used, they must be equivalent or greater than the minimum

parameters noted.

 Position containers on the autoclave cart below wrapped sets.

 For Immediate Use Steam Sterilization (IUSS), Aesculap recommends that each facility establish its own guidelines and

policies for processing, holding/transporting and using IUSS sets based on accepted industry standards, and OR and

patient needs.

 For PreVac Steam, stacking should not exceed 18 inches in height for effective air removal and adequate steam

penetration. Both solid and perforated bottoms can be stacked during sterilization and in storage.

 Container size abbreviations on modality charts

Detailed Size Description

Abbreviation Size Description

Full-Size

Three-Quarter

Half

XL-Long

Wide Body

XL-Mini

Quarter

Mini

1:1

3:4

1:2

XLL

Wide

XLM

Qtr

Mini

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

7.1.6 Steam and EtO – SterilContainer JK Series

Validated and FDA 510(k) Cleared Sterilization Modalities

JK Series

Bottom

1:1

JK440

JK441

JK442

JK444

JK446

3:4

JK740

JK741

JK742

JK744

1:2

JK340

JK341

JK342

JK344

JK346

Wide

JK817

JK821

XLL

JK443

Mini

JK187

JK188

A.

Lid

1:1

JK485

JK486

JK487

JK488

JK489

3:4

JK785

JK786

JK787

JK788

JK789

1:2

JK385

JK386

JK387

JK388

JK389

Wide

JE601

XLL

JK490

Mini

JK170

JK171

JK172

JK173

JK174

Processing

Supplies

PreVac Steam

(1)

PreVac IUSS

(2)

Gravity

(3)

EtO

(4)

Filter

US751, US994

MD344, JK090

US751, US994

MD344, JK090

N/A

US751, US994,

MD344

Indicator

Card

MD345, MD346

MD399

N/A

MD345, MD346

Lock

US900, US906

US900, US399

N/A

US900, US905

Filter

US999, MD355,

JK091

US999, MD355,

JK091

N/A

US999, MD355

Indicator

Card

MD876

N/A

N/A

MD876

Lock

US900, US906

US900, US399

N/A

US900, US905

Max Total

WeightA

25 pounds

25 pounds

Max weight based on industry guidelines. Weight limit may also be impacted by container size.

Follow sterilizer manufacturer IFU weight limits if less.

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

7.1.7 Steam and EtO – SterilContainer JK Series with PrimeLine Pro / PrimeLine Lid

Validated and FDA 510(k) Cleared Sterilization Modalities

JK Series

Bottom

1:1

JK440

JK441

JK442

JK444

3:4

JK740

JK741

JK742

JK744

1:2

JK340

JK341

JK342

JK344

1:1

JK440

JK441

JK442

JK444

3:4

JK740

JK741

JK742

JK744

1:2

JK340

JK341

JK342

JK344

A.

B.

Lid

1:1

JP101

JP102

JP103

JP104

JP105

3:4

JP111

JP112

JP113

JP114

JP115

1:2

JP121

JP122

JP123

JP124

JP125

1:1

JP001

JP002

JP003

JP004

JP005

JP006

JP007

3:4

JP011

JP012

JP013

JP014

JP015

JP016

JP017

1:2

JP021

JP022

JP023

JP024

JP025

JP026

JP027

Processing

Supplies

PreVac Steam

(1)

PreVac IUSS

(2)

Gravity

(3)

EtO

(4)

Filter, LidB

JP050

JP050

N/A

N/A

Filter, Bottom

N/A

N/A

N/A

N/A

Max Total

WeightA

25 pounds

Indicator

Card

MD345, MD346

MD399

N/A

N/A

Lock

US900, US906

US900, US399

N/A

N/A

Filter, LidB

JP050

JP050

N/A

N/A

Filter, Bottom

N/A

N/A

N/A

N/A

25 pounds

Indicator

Card

MD345, MD346

MD399

N/A

N/A

Lock

US900, US906

US900, US399

N/A

N/A

Max weight based on industry guidelines. Weight limit may also be impacted by container size.

Follow sterilizer manufacturer IFU weight limits if less.

JP050 reusable filter is integrated into the PrimeLine and PrimeLine Pro lids

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Aesculap® SterilContainer™ System Instructions for Use (IFU)

7.1.8 Steam and EtO – SterilContainer JN Series

Validated and FDA 510(k) Cleared Sterilization Modalities

JN Series

Bottom

Aluminum

Lid

1:1

JN440

JN441

JN442

JN444

JN446

3:4

JN740

JN741

JN742

JN744

1:1

JK485

JK486

JK487

JK488

JK489

3:4

JK785

JK786

JK787

JK788

JK789

1:2

JK385

JK386

JK387

JK388

JK389

XLL

JK490

1:2

JN340

JN341

JN342

JN344

JN346

XLL

JN443

JN445

Wide

JN817

JN821

Qtr

JN086

JN088

JN089

JN090

Mini

JN187

JN188

XLM

JN021

A.

Wide

JE601

Qtr

JN091

MD151

S76115

Mini

JK170

JK171

JK172

JK173

JK174

MD149

S76113

XLM

JK020

MD153

Processing

Supplies

PreVac Steam

(1)

PreVac IUSS

(2)

Gravity

(3)

EtO

(4)

Filter

US751, US994

MD344, JK090

N/A

US751,

US994

US751, US994,

MD344

Indicator

Card

MD345, MD346

N/A

MD345,

MD346

MD345, MD346

Lock

US900, US906

N/A

US900,

US906

US900, US905

Filter

US999, MD355,

JK091

N/A

US999

US999, MD355

Indicator

Card

N/A

N/A

N/A

N/A

Lock

US900, US906

N/A

US900,

US906

US900, US905

Max Total

WeightA

25 pounds

25 pounds

Max weight based on industry guidelines. Weight limit may also be impacted by container size.

Follow sterilizer manufacturer IFU weight limits if less.

Intended for US Only

As of February 2018

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