Attachment_1_-_Section_C_-_Statement_of_Requirements.docx

RFP #N6264517R0021

Attachment 1 Section C – Statement of Requirements

STATEMENT OF REQUIREMENTS

The Government has a requirement for Dental Delivery Systems in support of Navy MTFs, Hospital Ships and the Fleet. The Dental Delivery Systems shall be comprised of dental patient chair, delivery unit with assistant instrumentation, a patient light, assistant’s cart, and a doctor’s and assistant’s stools. Delivery orders may contain all or some of the items listed below and shall meet the following essential characteristics:

C.1. Dental Chair:

C.1.1. Shall be capable of being either bolted to the floor of a building or steel deck of a ship.

C.1.2. Shall be capable of swiveling a minimum of +/- 30° (left and right).

C.1.3. Shall have a built-in chair swivel brake.

C.1.4. Patient head rest shall have a range not to exceed a minimum of 14” and rise to a maximum of 70” off floor level.

C.1.5. Shall be available with seamless upholstery that can be cleaned and disinfected.

C.1.6. Shall be available with a programmable foot switch that controls the chair.

C.1.7. The base and back shall move by hydraulic means.

C.1.8. Shall have an option to order replacement upholstery.

C.1.9. Shall have patient arm rests and articulating head rest.

C.2. Delivery Unit:

C.2.1. Shall be capable of being either post or chair mounted.

C.2.2. Shall have a control pad which operates the chair and light, and a rheostat (footswitch) which operates the handpieces.

C.2.3. Shall be capable of accommodating a left- or right-handed dentist, without the use of tools.

C.2.4. Shall have a minimum of 3 handpiece hoses with the option to add an additional handpiece hose.

C.2.5. Shall have a holder capable of holding a minimum of 4 handpieces.

C.2.6. Shall have a 3-way syringe on the control head, to be utilized with disposable or autoclavable tips.

C.2.7. Shall be capable of providing a stainless steel tray and tray holder.

C.2.8. Shall be capable of providing all of the following: a 4 hole non-fiber optic, a 6-pin ISO, or a five-hole ISO, fiber-optic (bulb in the coupler) handpiece fiber-optic tubing and fiber-optic system. Hose configuration will be based upon site requirement.

C.2.9. Offeror shall provide a single part number for each repair parts kit(s) specific to the make/model of unit(s) delivered; at a minimum, offeror shall be capable of providing a syringe kit, foot control kit, control block kit, and air filters.

C.3. Assistant’s Instrumentation:

C.3.1. Shall be capable of providing a minimum of 4 position holder; Position 1 - High Volume Evacuator, Position 2 – Saliva Injector, Position 3 – Syringe, and Position 4 – Open.

C.3.2. Shall have a high and low volume evacuation line.

C.3.3. Shall have a 3-way syringe on the control head, to be utilized with disposable or autoclavable tips.

C.3.4. Instrumentation arm shall be a minimum of 22” long (along horizontal axis), but not to exceed 36” in length (along horizontal axis).

C.3.5. Shall have a control pad which operates the chair and light

C.4. Lighting System:

C.4.1. Lighting shall be produced by Light Emitting Diode (LED).

C.4.2. Shall be capable of being:

C.4.2.1. Track mounted.

C.4.2.2. Overhead mounted.

C.4.2.3. Chair mounted.

C.5. Utility Box:

C.5.1. Shall be capable of being floor, flush, or wall mounted, potentially requiring an umbilical to run the tubing and electrical power from a location up to 7 feet from the chair. Mounting requirements will be specified in the delivery order.

C.6. The dental delivery system shall include a self-contained water system, with a minimum capacity of 1 liter that will provide water to the dentist’s and assistant’s instrumentation and dental chair.

C.7. The dental delivery system shall be capable of being fully functional in a 9.75ft X 6ft room.

C.8. The dental delivery system shall have the option to include the following equipment:

C.8.1. Mobile assistant’s carts

C.8.1.1. Sliding top or fixed top

C.8.1.2. Four (4) wheels

C.8.1.3. A minimum of four (4) drawers

C.8.2. Dentist’s operator stools

C.8.2.1. With wheels

C.8.2.2. Seamless upholstery

C.8.2.3. Adjustable back support

C.8.2.4. Height adjustment

C.8.3. Assistant’s operator stools

C.8.3.1. With wheels

C.8.3.2. Seamless upholstery

C.8.3.3. Adjustable body support

C.8.3.4. Height adjustment

C.8.4. Integral curing light

C.8.5. Autoclavable scaler with control module

C.8.6. Electric handpiece motor

C.8.6.1. A minimum of 300-40,000 rpm

C.8.7. Shipboard braking system at all articulating points of the unit and light, which shall be capable of locking without the use of power. Vendor shall provide full detailing of how this is to be executed.

C.8.8. Shipboard systems shall include a strapping system or mechanism to firmly secure the dental light and dental unit to the dental chair during rough seas.

C.8.9. Integral standard female ¼” air and water lines with quick-disconnect fittings.

C.8.10. Monitor arm installed on dental chair.

C.8.11. 110VAC accessory dual gang receptacle or 220VAC accessory power outlet, as specified by the site.

C.9. Vendor shall provide color options. The specific color will be defined on each delivery order.

C.10. The electrical requirements of the dental delivery system and all accessories shall be capable of being ordered with 110-120 VAC or 220-230 VAC, 50 or 60 Hz, and shall use hospital grade plugs where applicable.

C.11. Pre-Packaged Assembly

C.11.1. Equipment shall be capable of being shipped completely disassembled or pre-assembled. The pre-assembled delivery option shall allow for minimal installation (i.e. floor/ceiling mounting and utility hookups) to be completed by the Government. The method of shipping will be specified prior to the placement of the delivery order.

C.12. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

C.13. The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

C.14. Additional Requirements for Delivery Orders

C.14.1. Some sites may require full-sized templates of dental equipment, which will be requested by the Government prior to the placement of the delivery order.

C.14.2. Shipping will occur to CONUS and OCONUS locations. The shipping location will be specified in each Delivery Order.

C.14.3. Installation may be required at CONUS and OCONUS locations.

C.14.3.1. Installation services will be required for shipboard installations in private, high security shipyards who handle nuclear material. The personnel conducting the installations must be U.S. citizens and must be able to pass a background investigation through the shipyard's designated background investigation contractor.

C.14.4. Equipment shall be capable of being shipped completely disassembled or partially assembled. The method of shipping will be specified prior to the placement of the delivery order.

C.14.5. Some sites may require the contractor to train Biomedical Equipment Technicians (BMETs) to service the equipment. Requirements for training will be addressed at the delivery order level.

C.14.6. Operators/Service Manuals. The vendor shall provide two (2) Operator Manuals and two (2) Service Manuals with each order placed for each site defined in the delivery order. The delivery order will specify whether the manuals shall be provided in digital format or hardcopy.