6530--RFI 36C26226Q0927 Guildmann OR EQUAL Patient Transfer Equipment 664-26-3-072-0118

STATEMENT OF WORK (DRAFT) 1. General Information 1.1. Description 1.1.1. Title of Project: Hospital-Wide Ceiling Lifts for VA San Diego Healthcare System 1.1.2. Background: Ceiling lifts have been installed in many places throughout the VA San Diego Healthcare System. The BHM Medical Voyager, Arjo Maxi Sky, Liko Likorall ceiling lifts installed in the facility have reached end of life. Many of the ceiling lifts that are currently still being used were installed in 2003 and 2006 which are now unsupported by the manufacturer. Most of these ceiling lifts do not have continuous-charge room covering rail systems and as a new requirement, will now require these rails, in accordance with requirements from VA Healthcare Technology Management (HTM) and VHA Directive 1611. Patients may arrive at any of these locations on a sling or be sent on to another location on a sling which require the ceiling lift systems being installed to be compatible with the current slings being used in these locations to avoid misuse of unfamiliar equipment. Compatibility of the ceiling lift system with assorted brands of slings is important because patients may also arrive wearing slings from home or may need to use specialized slings as part of their treatment from Barton/Humancare, Arjo, Hillrom/Liko, Guldmann, Wy’East, Inspire Outcomes, and/or Alpha Modalities to lift/ambulate patients and send them to other departments. 1.2. Type of Contract: Firm-Fixed Price 1.3. Quality assurance 1.3.1. Certification for compliance is required for Ceiling Mounted Patient Lift Systems. Certifications shall be provided by the manufacturer who will conduct testing to ensure that the ceiling lift and charging system are safe and in compliance with ISO 10535 & UL 60601-1. 1.3.2. Inspection of equipment after installation is required prior to use for patient movement. Inspection shall be in accordance with manufacturer’s installation checklist and the facilities installation checklist (Patient Safety Alert AL14-07). 1.3.2.1. This requirement is for Major and Minor projects where a commissioning agent is used and may be waived for NRM and Station Level projects if a VA COR or General Engineer can perform this work. Verify requirement with Medical Center. 1.3.3. Certification of compliance with VA requirements shall be provided by an independent third party, Inspector of Record (IOR), who will observe installation and manufacturer’s testing to ensure that the ceiling structure, ceiling lift, and charging system is safe and compliance with shop drawings, structural calculations, specifications, ISO 10535 requirements, and code requirements. IOR shall be a registered structural engineer in the state of installation. -- 1 of 7 -- 1.4. Submittals 1.4.1. Submit in accordance with specification section 01 33 23, shop drawings, product data, and samples. 1.4.1.1. Shop drawings shall show structural supports to the underside of structure. Structural calculations for the support of the track and its attachment to ceiling structure shall be submitted. Shop drawings used in the quoting phase shall be PDFs, and either 2D CAD files or 3D BIM files showing structural support to underside of structure. Shop drawings shall also provide general room layout with bed position and all obstructions to ceiling lift. 1.4.1.2. Once the purchase order is accepted by the vendor, a set of stamped drawings shall be provided by the vendor. Shop drawings and structural calculations shall be signed and stamped by a registered structural engineer, and shall meet all code requirements in the jurisdiction having authority. Structural engineer shall ensure ceiling minimum structure capacity shall support the loads specified in the shop and installation drawings and be in compliance with local structural and seismic codes. 1.4.1.3. Shop drawings shall show obstructions such as curtains, lights and sprinklers, and coordinate their relocation. 1.4.1.4. Manufacturer shall provide BIM (Building Information Model) for clash detection on the request of the Resident Engineer (RE), VA Construction Agent, or General Contractor. 1.4.2. Certificates of Compliance from Manufacturer 1.4.3. Manufacturer's Literature and Data: 1.4.3.1. Lifting Capacity 1.4.3.2. Lifting Speed 1.4.3.3. Vertical Axis Motor 1.4.3.4. Emergency Brake 1.4.3.5. Emergency Lowering Device 1.4.3.6. Emergency Stopping Device 1.4.3.7. Electronic Soft-Start and Soft-Stop Motor Control 1.4.3.8. Current Limiter for Circuit Protection 1.4.3.9. Strap Length 1.4.3.10. All equipment anchors and supports. Submittals shall include weights, dimensions, center of gravity of the structural support, standard connections, manufacturer's recommendations and behavior problems (e.g., vibration, -- 2 of 7 -- thermal expansion,) associated with equipment or piping so that the proposed installation can be properly reviewed. 1.4.4. Individual Room layouts showing location of lift system installation shall be approved before proceeding with installation of lifts. 1.4.5. Manufacturer’s Checklist for after installation inspection. 1.5. Applicable Publications 1.5.1. The publications listed below form a part of this specification to the extent referenced. The publications are listed in the text by the basic designation only. 1.5.2. International Organization for Standardization (ISO): 1.5.2.1. 10535-06 Hoist for the Transfer of Disabled Persons-Requirements and Test Methods 1.5.3. Underwriters Laboratories (UL): 1.5.3.1. 60601-1(2003) Medical Electrical Equipment: General Requirements for Safety 1.5.3.2. 94-2013 UL Standards for Safety Test for Flammability of Plastic Materials for Parts in Devices and Appliances-Fifth Edition 1.5.3.2.1. NOTE: As of April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007-03 or ANSI/AAMI/IEC 60601-1-2: 2007/(R)2012. 1.5.4. International Electromagnetic Commission (IEC): 1.5.4.1. 60601-1-2(2015) Medical electrical eq…