A21_W90VN6-19-Q-0020-0001.pdf

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STERRAD 100NX System
Solicitation number
W90VN619Q0020
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The purpose of this amendment is to add VELOCITY Reader and Access for requirements and Salient Characteristics

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FM529491560061

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

A. The purpose of this amendment is to add VELOCITY Reader and Access for requirements and Salient Characteristics.

B. The closing date/time is extended to from 19 Aug 2019 1300hrs to 9 Sep 2019, 1300hrs.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 3

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

16C. DATE SIGNED

BY 29-Aug-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W90VN619Q0020

X 9B. DATED (SEE ITEM 11)

31-Jul-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offer 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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 telegram or letter, provided each telegram or letter 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 NO. AS DESCRIBED IN ITEM 14.

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

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

29-Aug-2019

CODE

411TH CONTRACTING SUPPORT BRIGADE, KOREA

RCO OSAN, UNIT #2039

APO AP 96278-2039

UNITED STATES

W90VN6 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W90VN619Q0020

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

REVISED SPECIFICATIONS

Salient Characteristics Cycle Specifications:

-Be able to sterilize most general surgical instruments to include but not limited to; endoscopes, delicate instruments without lumens, anesthesia C-MAC blades, light cords, and cameras.

Technical Specifications:

-Cycle temperature between 47 degrees (minimum) Celsius and 56 degrees (maximum) Celsius

-Utilize Hydrogen Peroxide for sterilant

-Sterilant delivery is by closed system in cassettes with automatic detection of expiration date

-Automatic used cassette disposal

-Peroxide residual break down utilizing gas plasma technology to break down H2O2 as safe elements of water and oxygen

-Dimensions of the system must be no greater than a height of 1800mm (maximum)/1750mm

(minimum) and a width of 775mm (maximum)/770mm (minimum)

-Rectangular Chamber total volume of 152L (minimum) with dimensions of height: 410mm

(minimum), width: 510mm (minimum), depth: 735mm (minimum)

-Two-tiered shelf with a height of 445mm (maximum)/440mm (minimum) and depth of 645mm

(maximum)/640mm (minimum)

-No greater than a weight of 408kg (maximum)/380kg (minimum)

-Interface with touchscreen technology, resolution 800 X 600 pixels (minimum)

Sterilization Specifications:

-Must have terminal-sterilization, double-kill cycle to provide a Sterility Assurance Level of 10^-

6, 2 injections and identical plasma phases

-Delivered sterilant concentration must be between 58% (minimum) and 59.6% (maximum)

-Sterilization cycle monitoring with sensors and indicators

-Monitor H2O2 concentration using UV sensor within the chamber

Velocity Specifications:

-Dimensions of the system can be width 25 cm (maximum)/20 cm (minimum) and height of 15 cm (maximum)/10 cm (minimum)

-Connectivity must be available with Ethernet adaptor and a minimum of two USB ports

-Touch screen interface

-Must be able to have Biological Indicator results within 25 to 45 minutes

-Alarm system must be visible and audible in the event of a positive biological indicator result

-Power supply of 50/60Hz

W90VN619Q0020

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 19-Aug-2019 01:00 PM to 09-Sep-2019 01:00 PM.

The currency type for this contract has changed from US Dollars to Won.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

MFR: ASP (Advanced Sterilization Products) Model #: STERRAD 100NX SYSTEM, (Brand Name or Equal):

Installation & Delivery Cost included. (see the detail in specification)

To:

MFR: ASP (Advanced Sterilization Products) Model #: STERRAD 100NX SYSTEM with all clear techology and

Velocity Reader and Access, (Brand Name or Equal): Installation & Delivery Cost included. (see the detail in specification)

(End of Summary of Changes)

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