Statement of Work_Sterilizer Package_12.13.2023.pdf

Vision 1327 Cart Washer, V-Pro Max, AMSCO 400 Series Steam Sterilizers

13 Dec 2023

1. Introduction: Wright-Patterson Medical Center (WPMC) requires one (1) Vision 1327 Cart

Washer, three (3) V-Pro Max, and three (3) AMSCO 400 Series Steam Sterilizers.

2. Background: This equipment is essential for continue operations at Wright Patterson Medical

Center. Without this equipment we do not have sterilization capabilities which could halt a large portion of our 61K beneficiaries by shutting down our operating rooms and clinics that require sterile instruments.

3. Delivery:

o Base Access Point of Contact: SSgt Vivian Thompson 937-522-2756, Vivian.e.thompson5.mil@health.mil o Surgical procedure dates – If applicable (surgery) o Is hand delivery by sales representative required Y N N/A o Does sales representative need to be present during surgery Y N N/A

4. Building address: 4881 Sugar Maple Drive, BLDG 830, Wright Patterson AFB OH 45433

5. Minimum Requirements:

o Size –

▪ SPD Cart Washer (Vision 1327) – Dimensions: 120 x 112.75 x 130"; Chamber

Capacity: 40 x 80 x 106”

▪ Sterilizer – 26 x 37.5 x 60"

▪ V-Pro - 33 x 72 x 38-5/16"; Chamber Size is 17 x 15 x 32-1/2" o Design – N/A o Performance Requirements – Vision 1327 Cart Washer: A protective ground conductor is required (Class 1 Equipment). Main supply voltage fluctuation not exceeding ±10% of nominal voltage. Installation Category: Overvoltage Category II. Altitude of operation up to 6560 ft (2000 m). Temperature of 41 to 104°F (5 to 40°C). Maximum relative humidity is 80% for temperatures up to 88°F (31°C) decreasing linearly to 50% relative humidity at 104°F (40°C). Pollution degree 2: Equipment shall be installed in an environment where normally only non-conductive pollution occurs but where occasional, temporary conductivity caused by condensation can be expected (as determined according to International Standard EN/IEC 61010-1, Second Edition).

Washer/disinfector is positioned with required clearance space and in relation to building supply lines. Wall-mounted chemical dosing system is connected to washer/disinfector injection components and color-coded chemical feed lines. Each chemical pickup tube and low-level sensor are placed in proper color-coded container. Floor underneath and around washer/disinfector has a noncombustible and nonslip surface or is covered with a metal sheet extending to the outer edges of the washer/disinfector.

V-PRO max 2: Electrical – 200-230 volts, 50/60HZ Three Phase, current 16 amps, min.

circuit breaker 20 amps, use NEMA L15-20R plug. Provide grouped or ganged circuit

STATEMENT OF WORK

protection and disconnect for (3) phase power as required by NEC and local codes.

Individual power shutoffs recommended near each machine for servicing. Provide grounded metal conduit and wiring between equipment terminals and stub outs or disconnects. 14 AWG minimum size recommended. Physical specifications – Unit width is 33”. Door openings in facility shall be 36” wide or larger to accommodate sterilizer.

Floor space in loading/unloading areas of equipment to be level within 1/16”/ Service clearance shall be maintained to allow access to sterilizer for serviceability.

AMSCO 400 Series Steam Sterilizer: Environmental conditions for use are: temperature -

41-104 degrees F ; humidity – 85% non-condensing, maximum ; pollution degree – 2 ;

installation category – overall category II ; sound radiation – 68 dBA (mean per

ISO3746:2010). All water supply line shutoffs shall be provided with lockout capability.

Back flow prevention device installed. Water ejector specification is 30 to 50 psig (2.1 to

3.5 bar), dynamic. Vacuum pump specification is 20 to 50 psig (1.4 to 3.5 bar), dynamic.

Steam supply – shutoffs (with provisions for lockout and tagout) located nearby, supply piping adequately sized, supply pressure measured (specification is 50 to 80 psig [3.5 to

5.52 bar], dynamic). Drain piping shall be sloped properly, and sized to handle the maximum waste flow from the sterilizer. Electric single-phase service requires a clearly marked disconnect with lockout/tagout capability located near the sterilizer and installed according to local codes. Electric single-phase service should be on a separate circuit, and not tied into circuits containing large reactive loads (e.g., motors). The protective earth ground shall be connected to terminal block TB-1 in the sterilizer power box.

o Accessories – Yes, the AMSCO 400 sterilizer shall require a transfer carriage and loading car. The Cart washer shall require an instrument package that includes a new rack, cycle option control, manifold piping, pump system, flow meters, a pure water line, and a HEPA filter.

o Configuration – N/A o Installation & Testing – The contractor shall ensure the equipment is fully installed and operational by company engineers and product specialists. The contractor shall provide initial setup of equipment and perform initial validation calibration. The product/report shall be in accordance with CAP/TJC guidelines. The contractor shall provide necessary logistics for transport, delivery, unpackaging, assembling, and installation of new equipment. The contractor shall assume all responsibility for clean-up and disposal of any transport/packaging related waste materials post install.

o Training – The contractor shall provide onsite training. The contractor shall provide all expenses to include but not limited to travel, lodging, meals, and any additional expense that are training specific.

o Deinstallation and Disposal Requirements – Vendor shall de-install current units prior to installation of new. Vendor shall provide a detailed deinstallation plan outlining steps, timeline, and resources required. Vendor shall provide and resources necessary including tools, equipment, and manpower for the deinstallation process. Vendor shall comply with local safety regulations and industry standards. All deinstalled units shall be disposed of by the Medical Logistics Equipment Management Office.

o Warranty – First year preventative care maintenance shall be provided. The contractor shall provide 7 days a week, 24 hours hotline technical support in which a live person is available to provide verbal assistance. The contractor shall provide in-house technical maintenance support, within 24 hours of call being placed, to include weekends and holidays, if medical personnel are unable to troubleshoot/resolve any issues, failures, or errors. The contractor shall schedule and provide preventative maintenance on the equipment when required. The contractor shall provide all parts, labor, and services on the equipment. The contractor shall be able to provide onsite and remote support for the equipment as permitted by the Government network regulations. The contractor shall provide all software/hardware upgrades for the equipment.

o Standards, guidelines or approvals – Vision 1327 Cart Washer: meet the applicable

Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory

Use: Underwriters Laboratories (UL) Standard UL: 61010-1, Third Edition (2004) ;

EN/IEC 61010-1, Second Edition (2001) ; Canadian Standards Association (CSA):

CAN/CSA-C22.2 No. 61010-1, Third Edition (2004). Meets the following performance requirements: EN ISO 15883-1:2006 ; ANSI/AAMI ST15883-1:2009 ; CAN/CSA

Z15883-1:2009. Meets the following EMC/EMI regulations: Code of Federal Regulation, CFR 47 (2012) – FCC PART 15, SUBPART B Class A – Unintentional Radiators for

Use in Commercial and Industrial Areas ; Industry Canada, ICES-001 – Industrial, Scientific and Medical (ISM) Radio Frequency Generators, Issue 4, June 2006 ; EN

61326-1: 2006 – Electrical Equipment for Measurement, Control and Laboratory Use -

EMC Requirements, Part 1: General Requirements ; CISPR 11:2009 +A1:2010 / EN

55011:2009 +A1:2010, Class A, Group 1 – Limits and methods of measurements of radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment. Meets the following Governing Directives for affixing of the CE mark:

Medical Device Directive 93/42/EEC as amended by 2007/47/EC ; Machinery Directive

2006/42/EC ; EMC Directive 2004/108/EC - Class A, Group 1 ISM Equipment ; RoHS

Directive 2011/65/EU. Shall follow ANSI/AAMI/ISO 18472 2022 and ANSI/AAMI

ST79/2017 & 2020 Amendments.

V-PRO max 2: The installation of the V-PRO max 2 low temperature sterilization systems shall meet all federal, state, and local regulations (NEC in U.S., IEC in EU, and

CEC in Canada). Installation specification is listed as engineering and installation guides.

Per ANSI/AAMI ST58:2013 or subsequent, the sterilizer shall be installed and operated in an area with a ventilation system capable of at least 10 air exchanges per hour.

Sterilizer shall be installed and operated in an area where the temperature is between 59 and 86 degrees F (15 and 30 degrees C), and the relative humidity range is between 20% and 65%. Unit should not be installed in an area which is not compatible with oxidizers.

AMSCO 400 Series Steam Sterilizer: Shall meet AAMI ST-79, comprehensive guide to steam sterilization and sterility assurance in health care facilities. According to AAMI

ST-79, a steam penetration test shall be carried out at the beginning of each day the sterilizer is to be used. Any test package shall be constructed in accordance with instructions given in the AAMI ST-79 standard. ANSI/AAMI ST-79 requires an air removal (Bowie-Dick) test cycle be run as the first cycle each day the sterilizer is in use.

The chamber shall be at operating temperature when the test cycle is performed.

According to AAMI standards, a measured leak rate greater than 1mm Hg/minute (1.3 mbar/mil) indicated a problem with the sterilizer. Shall follow ANSI/AAMI/ISO 18472

2022 and ANSI/AAMI ST79/2017 & 2020 Amendments.

o Period of Performance – Total period of performance is 20 weeks after contract award.