SOW-Draft RFI 36C26226Q0927 Guldmann OR EQUAL Ceiling Patient Lifts.pdf

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.

1.4. 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, 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 equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral

Standard: Electromagnetic disturbances – Requirements and tests.

1.5.5. VA Patient Safety Alert AL14-07

2. Contract Award Meeting

2.1. The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer (CO) has conducted a kick-off meeting, or has advised the contractor that a kick-off meeting is waived.

3. Specific Mandatory Tasks and Associated Deliverables

3.1. Location of Ceiling Lift Installations: VA San Diego Healthcare System, Jennifer Moreno VA Medical Center (3350 La Jolla Village Drive, San Diego, CA 92161). Rooms are listed in the architect drawing attached as detailed in construction project 664-CSI- 203.

3.2. Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW.

4. Salient Characteristics

4.1. Ceiling Track System

4.1.1. The Ceiling Track shall be made from high strength extruded aluminum or VA approved equal. Provide anchor supports at ceiling substrate.

4.1.2. Installed rail shall be security tested for 1.5 times greater than the motor’s weight capacity and maximum allowable deflection of a horizontal rail is no more than

1mm (1/16th inch) per 200mm (7.87 inch) of track length. (As per ISO 10535 standards.)

4.1.3. The entire lift system, not only individual components, must be listed or certified by UL for medical electrical safety.

4.2. Lift System

4.2.1. The Lift Unit shall be constructed of a steel frame system driven by a gear reduced high torque motor.

4.2.2. Electronic soft-start and soft-stop motor control

4.2.3. Emergency lowering device

4.2.4. Emergency stopping device

4.2.5. Current limiter for circuit protection in case of overload.

4.2.6. Safety device that stops the motor to lift when batteries are low.

4.2.7. Emergency brake (in case of mechanical failure)

4.2.8. Cab: VO plastic–fire retardant, UL 94

4.2.9. Vertical Movement-DC Motor

4.2.10. The lift system must use a single-motor, single-strap configuration and must lift not less than 600 lb without multi-motor synchronization.

4.2.11. The lift system must include a wired hand control with an integrated display that shows patient weight and lift status or usage information.

4.2.12. The lift system must include an internal Class III scale with patient weight displayed on the hand control and must not require an external scale attachment for weighing.

4.2.13. The contractor must provide a minimum three-year warranty for the lift unit, batteries, lifting straps, and washable slings when slings are included in the purchase.

4.2.14. The lift system must provide automatic preemptive alerts for maintenance and service conditions, including low battery, inspection due status, faults, and other unsafe operating conditions.

4.2.15. The lift system must include onboard monitoring and networked communication of lift-use data, including at minimum number of lifts, lift category or type, patient load, and overload or near-overload events.

4.2.16. The lift system must be capable of wireless network communication (Wi-Fi connectivity) for issuance of alerts to staff and lift data.

4.2.17. The contractor must provide software that supports remote review and analysis of lift data and presents a dashboard showing frequency of use, location of use, and load trends.

4.2.18. The lift system must charge anywhere along the track and must not require a docking station or precise end-position alignment to initiate charging.

4.2.19. The lift system must provide hands-free, real-time dynamic body-weight support and fall protection during rehabilitation or mobility activities.

4.2.20. Clinical staff must be able to enter a target offload weight directly through the hand control, after which the system must automatically maintain the specified offload as the patient moves and center of gravity changes.

4.2.21. The offload setting must be adjustable during the same therapy or mobility session.

4.2.22. The track system must permit independent positioning and locking of the lift motor and/or traverse rail through the hand control when clinically indicated.

4.2.23. The lift system must include two fully independent emergency lowering mechanisms, one electrical and one mechanical.

4.2.24. All emergency lowering controls must be accessible from caregiver standing height and must not require ladders, stools, or elevated access.

4.2.25. Emergency lowering must not require an Allen wrench, hex key, or any other tool or specialized implement.

4.2.26. Emergency lowering must remain operable when an internal brake or overspeed brake has engaged.

4.2.27. The lift system must support future modular upgrades, including advanced mobility support, integrated weighing, data capture, and connectivity features, without requiring replacement of the installed lift system. 2.3 motors

4.3. Batteries

4.3.1. The life cycle (number of charging cycles) for batteries shall be in compliance with IEC 6100-1-2.

4.3.2. Provide rechargeable batteries with up to 35 transfers with a load of 200lbs (74kg) (for repositioning) // a minimum of 17 transfers with its maximum load.

4.4. Straps and sling

4.4.1. The straps shall meet ISO 10535 guidelines. The straps shall ensure the patient’s safety by preventing the patient from falling out of the sling.

4.4.2. The sling shall meet ISO 10535 guidelines. The sling shall cradle the body of the patient.

5. Execution

5.1. Installation

5.1.1. Install ceiling mounted patient lift system as per manufacturer's instruction and under the supervision of manufacturer's qualified representative and as shown on drawings.

5.1.2. If the distance in between the suspended ceiling and anchors is more than 12” consult with manufacturer to determine if lateral braces will be required.

5.2. Instruction and Personnel Training

5.2.1. Contractor will provide training on equipment use for all new types of equipment included in this contract scheduled after installation and before use, in coordination with VA POC (Point of Contact) or Contracting Officer Representative (COR).

5.3. Test

5.3.1. Conduct performance test, in the presence of the Resident Engineer (RE) and/or

Inspector of Record (IOR), and a manufacturer's field representative, to show that the patient lift system equipment and control devices operate properly and in accordance with design, specification, and code requirements.

5.4. Inspection

5.4.1. Inspection of installed ceiling mounted patient lift systems shall be conducted in accordance with the manufacturer’s installation checklist and the VA installation checklist (Patient Safety Alert AL14-07) prior to use for patient movement.

5.4.2. Periodic Inspection shall be provided by the manufacturer on a yearly basis in compliance with ISO 10535.