Statement of Work Medivator ENT 2022 (v2).pdf

AER for ENT Clinic

1. Introduction: Procurement and Installation of one (1) Automated Endoscope Reprocessing

System

2. Background: ENT Clinic formally used the PCI Medical Inc. GUS Cidex Disinfector to disinfect scopes. The scope types are Storz flexible rhino-laryngo fiberscope # 11101SK2, 11101 RP2. Findings during a TJC audit (February 2021), indicated that this method of disinfection did not meet High Level Disinfection (HLD) per IFU by Karl Storz. Currently the working alternative is to use 2 gallon capacity Cidex disinfectant bins. Handling of these bins is cumbersome and poses increased safety risk to staff due to spillage and lack of ventilation.

Delivery Date : Timeline of completion of work – Year end 2022 if not sooner.

o Requested delivery dates o Base Access Point of Contact o Surgical procedure dates – If applicable (surgery)

Y N N/A o Does sales representative need to be present during surgery Y N N/A o Is hand delivery by sales representative required

If yes please provide description of sales rep duties

4. Building address: 4881 Sugar Maple Drive, Wright-Patterson AFB, OH 45433

5. Minimum Requirements

STATEMENT OF WORK

o Size – 62Hx45Wx36D

Design - Advantage Plus ADV 1007 with air compressor o Performance Requirements – High Level Disinfection capability.

o Accessories – * Adv Su Rap Pa 110V w/AIR (ADV1007)

* Install, Advantage Plus Business Day ( INS1004)

* Rapicide Pa, Assembly 2/Ca (ML020117)

* Model M102-0118 Test Strips Rapi Pa 2X100 2/Pk

(ML020118)

* Spill Kit Rap Pa (78400974)

* Assy, Hookup Rac, Short (78400974)

* Model 2-8-030 Assy, Hookup, Pentax-0K

* Model 2-8-040 Assy, Hookup Storz-0K

* Model Cas-1000 Assy, Cassette, Transport (CAS1000)

* Model M102-0106 Intercept Detergent 4 x1/Ca (ML020106)

* ADVANTAGE PLUS™ Endoscope Reprocessor Complete Filter Package - MF01-0072 Filter package includes: Air filter (1/pkg of 8), Basin drain filter (2/pkg of 12), 0.4µ Pre-filter (4), 1µ Pre-filter (4) and 0.1µ Bacterial-retentive absolute filter (2).

*Air Filter (8 filters/box) - MF01-0028 Change filters on both sides every 6 months. Filter pkg will last approximately 12 months.

*Reusable Mesh Spray Arm Filter (one each) - 43100-254 This filter is located between the overflow valve and is part of the drain manifold assembly, one filter is used per each side. Clean monthly and replace as needed.

*Basin Drain Filters (12 filters/box) - MF01-0059 Change once per month. They are located inside of each basin at the drain. Remove these filters with: Basin Drain Filter Hook Part # 5-6-170.

*0.1 Micron Absolute Bacteria Retentive Water Filter (one each) - MF01-0069 This filter is located outside the ADVANTAGE PLUS Reprocessor. When looking at the pre-filtration it is located on the far left. It needs to be changed every 6 months or sooner if poor water conditions exist. Always keep one on hand and a water line disinfectant process must be performed when changing this filter.

*0.4 Micron Water Filter (one each) - MF01-0071 This filter is located outside the ADVANTAGE PLUS Reprocessor. When looking at the pre-filtration system, it is the filter in the middle of the pre-filtration system in between the 1 micron and the 0.1 micron. Change is pressure related, water pressure must be 35 psi or above. Always keep one on hand. Change at least every 6 months even if pressure remains above 35 psi.

*1 Micron Water Filter (one each) - MF01-0070 This filter is located outside the ADVANTAGE PLUS Reprocessor. When looking at the pre-filtration system, it is the filter located on the far right. Change is pressure related, water pressure must be 40 psi or above. Always keep one on hand. Change at least every 6 months even if pressure remains above 35 psi.

*Active Vapor Management (Charcoal) Replacement Filter (one each) - MF01-0068 If an Active Vapor Management system (AVM) is installed, it is located behind the machine. The AVM pulls harmful chemical vapors away from the user and passes it through this carbon filter, which neutralizes the vapors. This filter needs to be changed every 6 months.

* RAPICIDE™ PA Disinfectant (Two - 5 liter bottles each of Part A and Part B/case) - ML02-0117 The ADVANTAGE PLUS Reprocessor fits one each of Part A and Part B inside the system and each bottle connects to a specific uptake tube for accurate chemical mixing.

Approximately 44 cycles per case. Always make sure to have an extra case on-hand. NOTE: RAPICIDE™ PA Disinfectant is considered hazardous material and cannot be shipped overnight (i.e. shipped by air). Please allow at least 5 business days for delivery.

* RAPICIDE™ PA Indicator Test Strip (2 bottles/case, each bottle has 100 strips) - ML02-0118 Usage depends on how many procedures/day.

* INTERCEPT™ Detergent (4 - one gallon bottles/case) - ML02-0106 Endoscope detergent for pre-cleaning, proven to reduce biofilm. Use only one ounce (1 full pump) of INTERCEPT™ Detergent in three (3 ) gallons of water.

* INTERCEPT™ Wipes (4 containers/case, each container has 100 wipes) - ML02-0107 INTERCEPT™ Wipes are a low cost way to wipe down contaminated endoscopes and reduce biofilm.

• Configuration- N/A

• Installation & Testing-Installation is required/ testing of equipment prior to acceptance

• Training – Training is necessary and will be provided at no charge

• Warranty –Standard Manufacturer’s Warranty

• Standards, guidelines or approvals – N/A