STATEMENT OF WORK

Automated Endoscope Leak Tester – Leavenworth and Topeka

1. Background The Leavenworth and Topeka VA Medical Centers require Automated Endoscope Leak Tester Systems to improve efficiency in endoscope reprocessing. This device pressurizes a flexible endoscope to check for microscopic holes or breaches in its waterproof housing. It prevents hidden damage, avoids fluid invasion, and reduces the risk of cross-patient infections during procedures.

2. Items Sought

• Automated Endoscope Leak Tester System: 6x total, 3x Leavenworth VAMC, 3x Topeka VAMC

• Wall Mount Holder: 6x total, 3x Leavenworth VAMC, 3x Topeka VAMC

3. Automated Endoscope Leak Tester Salient Characteristics / Technical Specifications

• Capacity: Tests up to two endoscopes simultaneously

• Testing Method: Dry air leak testing (pressurization method; eliminates submersion requirement)

• Process: Automated three-step procedure with RFID scanning

• Display: Easy-to-read LCD with workflow instructions and real-time results

• Data Storage: Integrated RFID reader with up to 13,000 record capacity

• Data Export: Electronic export to PC for backup, audit and analysis

• Testing Modes:

- Automatic (computerized / dry leak test)

- Manual (operator-controlled / wet leak test)

• Quality Assurance: Built-in self-check on startup to verify system operation prior to use.

• Compatible with major flexible endoscope brands (e.g. Olympus, Fujifilm, Pentax)

• Included accessories:

- Leak Tester Air Tubes

- Power cords

- User ID Master Card

- Scope ID Master Card

- Card Holders

• Manufacturer Warranty

4. Brand Name or Equal Requirement The requirement for this acquisition is based on the ALT-Pro Automated Endoscope Leak Tester system by Olympus America Inc. The brand listed above is not specifically required, but serves as example to illustrate types of equipment that meet the required salient characteristics for this acquisition. Products considered “equal” must meet the salient physical, functional, or performance characteristics specified in this statement of work. The contractor is responsible for submitting sufficient documentation for the Government to evaluate “equal” items.

5. Warranty Vendor shall provide manufacturer warranty with documentation. This documentation shall detail the scope of coverage, coverage timeline, and specific remedies if a defect occurs.

6. On-site Installation and Configuration On-site installation of the system at specified locations shall include:

• Electrical connection and safety verification

• RFID reader calibration and functionality testing

• LCD display configuration and system settings initialization

• Network connectivity setup for electronic data export

• Self-check diagnostic run to verify proper operation

7. On-site Training The contractor shall provide hands-on training for up to 15 to clinical staff prior to equipment use. This training shall be conducted by a manufacturer-trained representative. This training will take place on site at VA facilities. Training will consist of:

• Three-step automated testing process: Scan (RFID), Connect, and Start

• Instruction on automatic and manual testing mode selection

• Guidance on LCD display interpretation and workflow instructions

• Record keeping and data management training

• Troubleshooting and basic maintenance procedures

8. Documentation and Compliance Upon delivery, setup, and training, the vendor shall provide documentation to include the following:

• Complete user documentation and operating procedures

• RFID database setup with endoscope model specifications

• Quality assurance protocols aligned with facility standards

• Training completion sign-in sheet or certificate

• Post-installation support contact information sheet.

• Documentation of facility-specific procedures

9. Post-installation Support Vendor shall provide documentation to outline post-installation questions and troubleshooting, to include:

• Type of on-call support offered

• Email and phone support for technical questions

• Troubleshooting support for any system issues

• Guidance on optimization and best practices

• Initial preventive maintenance guidance

• Guidance on advanced features and data management

• Assistance with RFID database maintenance

• Preventative maintenance recommendations and schedule