Amendment_01_HT001426QE027.pdf

R

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBE

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Solicitation/Contract Form

The following modifications were made:

Information From To Response Due Date 01 Sep 2026 22 Sep 2026

List of Attachments

Header Miscellaneous Text (Modified):

Statement of Need (SON)

Anterior Segment Ophthalmic Surgical System(Phacoemulsification & Vitrectomy Platform)

1. Scope& Objective

The purpose of this acquisition is to procure a state-of-the-art, high-performance anterior segment ophthalmic phacoemulsification surgical system. The system will be utilized in surgical operating rooms for cataract extraction, lens fragmentation, aspiration, and associated anterior segment ophthalmic procedures. The platform must provide advanced fluidics management, multi-modal ultrasonic cutting capabilities, integrated diathermy, high-definition video output, and robust wireless control interfaces to maximize surgical safety, anterior chamber stability, and operational efficiency.

2. Minimum Technical Specifications

The proposed equipment must meet or exceed the following minimum technical, functional, and performance capabilities.

2.1Phacoemulsification & Ultrasonic Performance

Ultrasound Operating Modes: Must support Continuous, Pulse, and Burst submodes with linear control via foot pedal.

Cutting Modalities:

Must support conventional longitudinal ultrasonic tip excursion with a full stroke capability of at least at 100% power.

Must support non-longitudinal (torsional, oscillatory, or equivalent transversal) ultrasonic cutting action with an amplitude of at least at 100% power to minimize thermal friction and repelling forces.

Resonant Frequency: System operating drive frequency must function within the range of to .

Pulse Modulation:

Pulse Rate: Variable from to at least .

Duty Cycle (On-Time): Adjustable from to .

Burst Timing Control:

Burst-On Time: Programmable from to at least .

Burst-Off Time: Programmable from up to at least .

2.2 Fluidics: Irrigation and Aspiration (I/A)

Active / Intraocular Pressure (IOP)-Controlled Irrigation:

System must support an active fluidics system capable of targeting and maintaining intraocular pressure throughout the surgical procedure.

Target Pressure Range: Programmable IOP set points between and .

Dynamic Response Time: Active pressure adjustment must achieve a step response within or faster.

Targeting Accuracy: Pressure delivery accuracy within.

Standard Gravity/Assisted Irrigation:

Flow Rate Capability: Adjustable from to at least .

Fluid Reservoir Compatibility: Supports usable fluid volume of up to with a measurement volume accuracy of.

Aspiration & Vacuum Management:

Maximum Vacuum Limit: Capable of generating vacuum levels of at least (700+ mmHG vacuum measurement requirements).

Aspiration Flow Rate: Continuously adjustable from to at least (700+ mmHG vacuum measurement requirements).

Vacuum Rise Time: Rapid vacuum rise dynamics of no greater than at an aspiration flow of 700+ mmHG vacuum measurement requirements.

Aspiration Flow Accuracy: Delivery accuracy within or (whichever is greater to 700+ mmHG vacuum measurement requirements).

HT001426QE0270001

1.

2.

3.

2.3 Bipolar Diathermy / Coagulation

Radiofrequency Output: Monopolar or bipolar electrocoagulation capability operating at an RF center frequency of .

Power Output Range: Continuously variable from to into a rated non-inductive load of .

Power Accuracy: Calibration tolerance within .

2.4 Control Systems & Ergonomics

Wireless Foot Controller:

Ergonomic, multi-axis, programmable foot pedal with wireless connection.

Weight must not exceed () to allow easy repositioning while maintaining floor stability.

Water Ingress Protection: Submersible to medical grade IPX8 standard.

Remote Control:

Handheld wireless remote control for circulator/technician adjustments.

Powered by standard, readily replaceable commercial batteries (e.g., ).

Water Ingress Protection: Splash-proof rated to at least IPX4 standard.

Wireless Communication:

Secure industrial RF/Bluetooth wireless connectivity between console, foot controller, and remote interface.

Reliable operating line-of-sight/operating range of at least ().

2.5 Video, Connectivity, and Network Security

Video Display / Output: Integrated or external digital output supporting ultra-high-definition (UHD / 4K) resolution to connect to surgical displays or recording systems.

Wired Connectivity:

High-speed Ethernet port: RJ-45 supporting Gigabit Ethernet ().

Peripheral Data Ports: At least two (2) accessible USB 3.0 Type-A ports ( throughput) for log exports, surgeon profile management, and firmware upgrades.

Wireless Network Interface:

Integrated dual-band Wi-Fi (, ) with data throughput rates up to .

Cybersecurity & Network Authentication:

Must meet enterprise-grade hospital network authentication standards.

Required protocols: WPA2-PSK, WPA2-Enterprise, WPA3-Personal, and WPA3-Enterprise (including 192-bit cryptographic mode).

2.6 Electrical, Safety, & Ingress Standards

Input Power: Universal AC input spanning to nominal (), operating at or .

Current Draw: Maximum current draw within to depending on mains voltage.

Patient Safety / Applied Part Classification: Electrical isolation complying with Type BF (Body Floating) medical equipment standards in accordance with

IEC 60601-1.

Console Ingress Protection: Minimum enclosure rating of IP10 against particulate intrusion.

2.7 Environmental Operating & Storage Limits

Operating Environment:

Temperature Range: to ( to ).

Relative Humidity: to , non-condensing.

Altitude: Sea level () up to ().

Non-Operating / Transit / Storage Environment:

Temperature Range: to ( to ).

Relative Humidity: to , non-condensing.

Altitude: Sea level () up to ().

3. Regulatory, Quality, and Compliance Requirements

FDA Clearance: The device must be FDA cleared (510(k) or PMA) for anterior segment ophthalmic surgery and phacoemulsification.

Electrical Safety Standards: Compliance with ANSI/AAMI/IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety and Essential Performance) and IEC 60601-1-2 (Electromagnetic Compatibility).

Traceability & Standards: Manufacturing processes must conform to ISO 13485 or current Good Manufacturing Practices (cGMP).

4.Deliverables & Services

Core Hardware: Phacoemulsification console, primary display, wireless foot controller, wireless remote control, standard transducer handpieces, and power cables.

Accessories: Reusable tool sets, calibration blocks/test chambers, and interface cabling.

Documentation: Complete operator/user manuals, technical service manuals, and biomedical engineering maintenance protocols.

Installation & Clinical Training: On-site unpacking, assembly, technical verification, and clinical application in-service training for surgeons, scrub technicians, and nursing personnel.

Warranty & Technical Support: Minimum one (1) year comprehensive warranty covering all parts, labor, travel, and annual preventive maintenance.

HCD NORTHEAST, 8111 GATEHOUSE ROAD, 2ND FLOOR

FALLS CHURCH, VA 22042

UNITED STATES

Justin Balster, Email: justin.balster2.civ@health.mil Telephone: 7578695995 AdminBy:

SCD: PAS: