STERIS Sole-Source Statement.pdf

April 1, 2017

Subject: Sole Source

Dear Customer:

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

All replacement parts manufactured or marketed by STERIS Corporation 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 factory trained personnel who maintain our equipment through preventive maintenance agreements assuring that STERIS-manufactured equipment continues to operate in compliance with OEM specifications.

As the manufacturer of STERIS equipment, we recommend taking a number of factors into consideration when determining the appropriate number of annual preventive maintenance (PM) inspections for equipment that is outside the warranty period. These factors include, but are not limited to: previous experience with the machine, adherence to recommended routine operator maintenance protocol, quality of utilities, technical expertise of the service provider, and equipment usage rates.

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

Routine Maintenance:

Steam Sterilizers 2 PM inspections annually Electric Sterilizers 4 PM inspections annually Generators – Stand Alone 4 PM inspections annually V-PRO® Low Temperature Sterilization Systems

(VHP)

2 PM inspections annually or every 750 cycles, whichever is more frequent

Washers 4 PM inspections annually Surgical Equipment-Lights, Tables, EMS, Scrub Sinks, Warming Cabinets & OR Integration 2 PM inspections annually

SYSTEM 1E® Liquid Chemical Ster ilant Processing System 4 PM inspections annually

Ultrasonic – Floor Models 2 PM inspections annually

Recommended Chamber Cleaning:

Sterilizer Chamber Cleanings 1 annual cleaning

Sincerely, Debra Huya

Debra Huya Manager, Service Contracts

(440) 392-7629 phone

(440) 392-8932 fax

83011669/21 11