RFI -Dental Field Operating System - Attachment 2 - PANMRA-20-P-0000 002995.pdf

Attachment 2

The attributes listed in the table below reflect desired capability to be accommodated by the responder offering Dental Field Operating System.

Instructions to Offeror: In far-right column, please indicate Y (Yes) or N (No) if your system meets each characteristic in the table below, and provide any comments to further clarify to what extent your product meets each attribute. If your system does not meet any given attribute, please indicate characteristics of your system.

Essential

Characteristics (EC)

Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Regulatory Approvals Shall have FDA 510(k)

Clearance as Class II

Medical Device prior to issuance of the first

Delivery Order

T = O

Electrical Safety &

EMC

Vendor shall adhere to

IEC 60601-1 and IEC

60601-1-2

T= O

Operating System Shall have an electrically operated dental operating unit that includes any air compressor required for full operation.

T = O

Operational Availability Shall have at least .95 when operated for a 30 day period.

Shall have at least

.98 when operated for a 30 day period.

Oral Evacuation System Shall have a suction flow of no less than 3.5 standard cubic feet per minute (SCFM), at a negative pressure of 4 inches of mercury.

Shall have a suction flow of no less than 6 standard cubic feet per minute (SCFM), at a negative pressure of 4 inches of mercury.

Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Saliva Ejector

(Aspiration System)

Shall be capable of flow of no less than 1.2 standard cubic feet per minute (SCFM) at 1.5 inches of mercury.

T=O

Water System Shall be self-contained and have a volume capacity of no less than

500 milliliters.

T=O

Water System Check

Valves

Shall have check valves to prevent water from flowing back into air and water systems.

T=O

Internal Air System Shall provide air to the air/water

Syringe, and air for cooling the hand piece head.

T=O

Power Source Shall operate from

110/220 voltage, alternating current+/-

10%, 50/60 hertz.

Shall operate from

28Volts/DC, direct current and solar power.

Pedal Shall be able to control the water group and also the functions of the hand pieces.

T=O

Drainage System Shall allow a means for fluid drainage prior to storage.

T=O

Operational Noise

Level

The system shall not exceed noise level of 75 decibels (dB).

The system shall not exceed noise level of 50 decibels

(dB).

Waste Storage Shall provide a 1 liter or larger waste container with auto-overflow cut-off.

T=O

Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Operational

Environment

The system will operate after being stored in temperatures ranging from 0 to 120 degrees F, from 20 to 95% humidity, non-condensing, once brought up to operating temperature.

Hand Pieces a. Shall have a fiber optic lighting system that provides a minimum of 40,000 lux with the light beam existing at the dental burr. The light system shall also serve as an intraoral exam light with the capability of illumination on demand, or remain illuminated for a period of 10 to 20 seconds after the burr is no longer rotating.

b. The air and water cooling spray that exits at the burr shall be located within the body of the hand piece motor and attachment.

c. The speed of the motor shall be 0- 40,000 revolutions per minute.

The burr speed shall be adjustable via either the foot switch or the instrument panel.

d. The unit shall include an ultrasonic scaler capability.

e. The motor shall be compatible with hand pieces that have the capability to perform:

(1) Surgery Straight

Nosecone - 1:1.

(2) High Speed General

Dentistry Hand Piece -

1:5.

(3) Endodontic Hand

Piece 8:1.

Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

f. Shall operate the high-speed hand piece/s simultaneously with the oral evacuation and saliva ejector systems.

Packaging a. The container(s) for the system shall permit transportation by normal modes to include land, sea, and air without damage to the equipment.

b. The systems shall be packaged in two containers, with a weight no greater than

70 pounds (lbs.), without shipping case, and 120 lbs. with shipping case.

c. In the appropriate container(s), the system shall be capable of being carried by no more than three soldiers.

a. The container(s) for the system shall permit transportation by normal modes to include land, sea, and air without damage to the equipment.

b. The systems shall be packaged in one container, with a weight no greater than 70 pounds (lbs.), without shipping case, and 120 lbs.

with shipping case.

c. In the appropriate container(s), the system shall be capable of being carried by no more than two soldiers.

Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Logistics a. The system will be repairable with standard tools at organization and support level maintenance tiers.

b. The mean time between operational mission failure will be at least 360 hours.

c. The mean time to repair will be less than three hours.

d. The complete system will fit into a High

Mobility Multipurpose

Wheeled Vehicle for transportation (Space

Dimensions: 84.3" x

52" x 35").

a. The system will be repairable with standard tools at organization and support level maintenance tiers.

b. The mean time between operational mission failure will be at least 540 hours.

c. The mean time to repair will be less than two hours.

d. The complete system will fit into a High Mobility

Multipurpose

Wheeled Vehicle for transportation

(Space

Dimensions: 84.3" x 52" x 35").

Environmental, Safety and Occupational

Health

a. The system will present no uncontrolled safety hazards to personnel throughout its lifecycle.

b. The system will be mutually compatible with other equipment in the operational electromagnetic environment.

1. INTEGRATED PRODUCT SUPPORT (IPS)

This list of parameters details the logistical characteristics and practices the system and vendor should be complicit with. Unless otherwise specified, Threshold (T) requirements are equivalent to Objective (O) requirements.

ILS Parameter Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Packaging Case The complete Dental

Operating system with all parts and accessories should be packaged in a single hardened transport case.

T=O

Repair Tools The system should be able to be maintained with the tools found in the existing Biomedical

Equipment specialist toolkit (Government to supply the current list) and not require any proprietary tools for maintenance.

T=O

Operating Temperature Should withstand low and high operating temperatures mentioned in the OEM technical literature without degradation of performance.

T=O

Humidity Should be capable of being stored in locations where humidity would be up to 90%.

T=O

Low Temperature

Storage

The system should be capable of low temperatures storage to

-33°C IAW MIL-STD-

810G-502.5: Basic Cold

(C1).

T=O

High Temperature

Storage

The system should be capable of high temperatures storage to

+71°C IAW MIL-STD-

810G-501.5: Hot Dry

(A1).

ILS Parameter Threshold [T]

(Minimum)

Objective [O] Meets Desired

Threshold

Attribute?

(Y/N) and

COMMENTS

Loose Cargo Transport The system should be fully operational after military transport as loose cargo IAW MIL-

STD-810G method

514.6.

T=O

Drop Test The system should function after being dropped from heights of

4 feet in the transit case

IAW MIL-STD-810G

method 516.6, procedure IV.

(End)