P09 Functional Performance Specs.docx

Functional/Performance/Specification General Equipment Name: Brand Name or Equal PHACOEMULSIFICATION UNITS Description & Salient Characteristics The Iowa City VA HCS Operating Room is requesting Brand Name or Equal to Bausch + Lomb Phacoemulsification System and handpieces currently in use in the Operating Room. Any vendor offering an “equal” item must clearly describe how their product meets or exceeds each of the below minimum specifications and provide supporting documentation.

Phacoemulsification System:

· Dimensions: 48”h x 18” w x 18” d.

· Must have a minimum of 18” touchscreen and no greater than 19” touchscreen.

· Must have a frequence of 28.5 kHz.

· Must have up to 130 µm (longitudinal motion).

· Must have a pulse mode range of 1-250 pulses per second.

· Must have longitudinal motion type.

· Must have gravity and/or pressurized air.

· Must have a rotary vane vacuum pump.

· Must have a vacuum range of 0-600 mmHg.

· Must support 20-gauge, 23-gauge, and 25-gauge handpieces.

· Must have a cutting rate of 30-800 cuts per minute.

· Must have a dual-linear foot pedal (wireless or wired).

· Foot pedal must have independent control over the ultrasound, vacuum, aspiration, and irrigation.

Ultrasound Phaco Handpiece:

· Must be compatible with Stellaris system currently in use at the Iowa City VA HCS Operating Room without the use of adapters or modifications.

· Must have a six-crystal piezoelectric design.

· Must operate on a 28.5 kHz ultrasonic frequency.

· Must integrate with Stellaris foot pedal platforms.

Service Plan:

The service plan must provide full support for the Stellaris phacoemulsification unit, including all system modules, foot pedal, display, fluidics system, internal vacuum/infusion components, and associated handpiece ports.

The contractor shall provide annual or semi‑annual preventive maintenance that includes:

• Full system inspection and operational testing

• Verification of ultrasound power output

• Testing and calibration of vacuum and irrigation systems

• Foot pedal function testing and calibration

• Replacement of worn components as required by OEM standards

• Software/firmware updates when applicable

• Electrical safety inspection in accordance with NFPA 99 and facility requirements The plan must include unlimited on‑site repair visits to restore equipment to full operational status. Corrective service must include:

• OEM‑equivalent repair procedures

• Replacement of failed electrical, mechanical, or fluidic components

• Diagnostics for system error codes and performance failures

• Handpiece port repair and calibration

• Foot pedal repair or replacement if failure is related to the system On‑site response: Within 48 hours of service call (or better if required by the facility).

Replacement Parts:

The service contractor must provide:

• All replacement parts OEM or OEM‑equivalent

• All consumable internal components required for PM or repair

• No additional cost for parts, shipping, or labor Loaner Equipment If the system becomes inoperable for more than 72 hours, the contractor must provide:

• Loaner phaco unit and/or handpieces, if available, or

• Equivalent temporary equipment ensuring clinical operations are not interrupted Period of Performance

• 12‑month base period

• Up to 4 option years (if used in a service contract format) Required Individual Line Items & Quantity of Items

· (2 each) Stellaris Elite Anterior Deluxe System.

· (2 each0 5-year service plan per unit.

· (15 each) Ultrasound Phaco Handpiece.

Optional Line Items

· Delivery Requirements:

· Include any shipping costs that are not included in the cost of the line items.