STERIS CORP Sole Source Letter.pdf

February 25, 2025

Subject: Sole Source Authorized Service Provider Dear Customer:

Please be advised STERIS is the sole factory-authorized supplier of parts and service for the equipment we manufacture, including products under the brand names of AMSCO, Finn Aqua, HAMO, Black Diamond Video, Medisafe and Cantel/Medivator.

All replacement parts manufactured or marketed by STERIS are compliant with original equipment manufacturer (OEM) specifications. These parts are sold and shipped directly to the end user of the products. STERIS does not utilize a distributor model.

STERIS has over 950 trained personnel who maintain our equipment through preventive maintenance agreements assuring STERIS-manufactured equipment continues to operate in compliance with OEM specifications.

As the manufacturer of STERIS equipment, we recommend taking several factors into consideration when determining the appropriate number of annual preventive maintenance (PM) inspections for equipment both in and outside the warranty period (typically one year from installation). These factors include but are not limited to previous experience with the machine, adherence to recommended routine operator maintenance protocols, quality of utilities, technical expertise of the service provider, and equipment usage rates.

Unless there are complicating factors, as described above, the preventive maintenance set forth in the chart is recommended and is consistent with the PM visits covered by our current standard service agreements. Please work with your STERIS service representative to determine, taking into consideration all relevant factors, if the appropriate quantity of PM visits for your equipment differs from that set forth in the standard service agreement. STERIS is in the process of revising service and maintenance manuals to reflect our updated recommendations.

Routine Maintenance:

Equipment Annual PM Inspections First Year PM Inspections Steam Sterilizers 2 PM inspections annually 1 PM inspection Electric Sterilizers 4 PM inspections annually 1 PM inspection Sterilizer Loading Equipment 1 PM inspection annually N/A Generators – Stand Alone 4 PM inspections annually 2 PM inspections V-PRO® Low Temperature Sterilization Systems (VHP)

2 PM inspections annually or every 750 or 1,000 cycles*;

whichever is more frequent

2 PM inspections annually or every 750 or 1,000 cycles*;

whichever is more frequent

Single Chamber Washers Disinfectors and Cart Washers

4 PM inspections annually 1 PM inspection

AMSCO 7052/7053HP Single Chamber Washers and AMSCO 1215 Cart Washer

2 PM inspections annually 1 PM inspection

SCS Conveyor Modules 2 PM inspections annually 1 PM inspection Reliance Load and Unload Modules 4 PM inspections annually N/A Washer/Disinfector Manifold Racks 2 PM inspections annually N/A Robotic Assisted Surgery (RAS) 12 Rack 1 PM inspection annually N/A

Surgical Equipment-Lights, Tables, EMS, Scrub Sinks, Warming Cabinets & OR Integration

2 PM inspections annually 1 PM inspection

SYSTEM 1E® Liquid Chemical Sterilant Processing System

4 PM inspections annually 3 PM inspections

Ultrasonic Cleaners and Consoles** 2 PM inspections annually 1 PM inspection Medivator AERs and Endodry Cabinets 1 PM inspection annually Endoscope Storage Cabinet (ESC) 2 PM inspections annually

TruFreeze 1 PM inspection annually

* As dictated by unit configuration ** Note: Innowave ultrasonic cleaner calibration can only be performed by STERIS technicians.

Recommended Chamber Cleaning:

Sterilizer Chamber Cleanings 1 annual cleaning* STERIS Cart Washer Chamber Cleaning 1 annual cleaning* STERIS Single Chamber Washer Chamber Cleaning 1 annual cleaning* VPRO Low-Temperature Sterilizer Chamber Cleaning 1 annual cleaning*

*Increased frequency of chamber cleaning may be needed.

Sincerely, Greg Haire

North American Healthcare Service

Sincerely, Greg Haire