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OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600...

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OFFICE OF STATEWIDE HEALTH PLANNING AND DEVELOPMENT FACILITIES DEVELOPMENT DIVISION “Access to Safe, Quality Healthcare Environments that Meet California’s Diverse and Dynamic Needs” STATE OF CALIFORNIA – HEALTH AND HUMAN SERVICES AGENCY OSH-FD-700 (REV 3/13/14) Page 1 of 2 APPLICATION FOR OSHPD PREAPPROVAL OF MANUFACTURER’S CERTIFICATION (OPM) OFFICE USE ONLY APPLICATION #: OPM-0106-13 OSHPD Preapproval of Manufacturer’s Certification (OPM) Type: New Renewal Update to Pre-CBC 2013 OPA Number: OPA-0627-10 Manufacturer Information Manufacturer: Ortho Clinical Diagnostics Part of the Johnson & Johnson Family of Companies Manufacturer’s Technical Representative: Frank Koetter Mailing Address: 100 Indigo Creek Drive, MC00891, Rochester, NY 14626-5101 Telephone: 1-585-453-4003 Email: [email protected] Product Information Product Name: Vitros 4600 & 4600AT Chemistry Systems Product Type: Clinical Chemistry System Product Model Number: Vitros 4600 & Vitros 4600 AT General Description: Chemistry System Blood Analyzer Applicant Information Applicant Company Name: Ortho Clinical Diagnostics Part of Johnson & Johnson Family of Companies Contact Person: Frank Koetter Mailing Address: 100 Indigo Creek Drive, MC00891, Rochester, NY 14626-5101 Telephone: 1-585-453-4003 Email: [email protected] I hereby agree to reimburse the Office of Statewide Health Planning and Development review fees in accordance with the California Administrative Code, 2013. Signature of Applicant: Date: 5/9/14 Title: Group Director, Systems Development & LCM Company Name: Ortho Clinical Diagnostics 01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 29 Jeffrey Y. Kikumoto OPM-0106-13 01/09/2015
Transcript
Page 1: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

OFFICE OF STATEWIDE HEALTH PLANNING AND DEVELOPMENT FACILITIES DEVELOPMENT DIVISION

“Access to Safe, Quality Healthcare Environments that Meet California’s Diverse and Dynamic Needs”

STATE OF CALIFORNIA – HEALTH AND HUMAN SERVICES AGENCY OSH-FD-700 (REV 3/13/14) Page 1 of 2

APPLICATION FOR OSHPD PREAPPROVAL OF MANUFACTURER’S CERTIFICATION (OPM)

OFFICE USE ONLY

APPLICATION #: OPM-0106-13 OSHPD Preapproval of Manufacturer’s Certification (OPM)

Type: New Renewal Update to Pre-CBC 2013 OPA Number: OPA-0627-10

Manufacturer Information

Manufacturer: Ortho Clinical Diagnostics Part of the Johnson & Johnson Family of Companies

Manufacturer’s Technical Representative: Frank Koetter

Mailing Address: 100 Indigo Creek Drive, MC00891, Rochester, NY 14626-5101

Telephone: 1-585-453-4003 Email: [email protected]

Product Information

Product Name: Vitros 4600 & 4600AT Chemistry Systems

Product Type: Clinical Chemistry System

Product Model Number: Vitros 4600 & Vitros 4600 AT

General Description: Chemistry System Blood Analyzer

Applicant Information

Applicant Company Name: Ortho Clinical Diagnostics Part of Johnson & Johnson Family of Companies

Contact Person: Frank Koetter

Mailing Address: 100 Indigo Creek Drive, MC00891, Rochester, NY 14626-5101

Telephone: 1-585-453-4003 Email: [email protected]

I hereby agree to reimburse the Office of Statewide Health Planning and Development review fees in accordance with the California Administrative Code, 2013.

Signature of Applicant:

Date: 5/9/14

Title: Group Director, Systems Development & LCM Company Name: Ortho Clinical Diagnostics

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 2: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

OFFICE OF STATEWIDE HEALTH PLANNING AND DEVELOPMENT FACILITIES DEVELOPMENT DIVISION

“Access to Safe, Quality Healthcare Environments that Meet California’s Diverse and Dynamic Needs”

Registered Design Professional Preparing Engineering Recommendations

Company Name: CYS Structural Engineers, Inc.

Name: Dieter T. Siebald California License Number: S.E. #4346

Mailing Address: 2495 Natomas Park Drive, Suite 650, Sacramento, CA 95833

Telephone: 916-920-2020 Email: [email protected]

OSHPD Special Seismic Certification Preapproval (OSP)

Special Seismic Certification is preapproved under OSP- (Separate application for OSP is required)

Special Seismic Certification is not preapproved

Certification Method(s)

Testing in accordance with: ICC-ES AC156 FM 1950-10

Other* (Please Specify):

*Use of criteria other than those adopted by the California Building Standards Code, 2013 (CBSC 2013) for component supports and attachments are not permitted. For distribution system, interior partition wall, and suspended ceiling seismic bracings, test criteria other than those adopted in the CBSC 2013 may be used when approved by OSHPD prior to testing.

Analysis

Experience Data

Combination of Testing, Analysis, and/or Experience Data (Please Specify):

List of Attachments Supporting the Manufacturer’s Certification

Test Report Drawings Calculations Manufacturer’s Catalog

Other(s) (Please Specify):

OFFICE USE ONLY – OSHPD APPROVAL VALID FOR CBC 2013 ONLY

Signature: Date: 01/09/2015

Print Name: Jeffrey Kikumoto

Title: SSE

Condition of Approval (if applicable):

STATE OF CALIFORNIA – HEALTH AND HUMAN SERVICES AGENCY OSH-FD-700 (REV 3/13/14) Page 2 of 2

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 2 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 3: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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TABLE OF CONTENTS

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 4: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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GENERAL NOTES

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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GENERAL NOTES (CONTINUED)

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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GENERAL NOTES (CONTINUED)

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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DESIGN CRITERIA

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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ABBREVIATIONS

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600

PLAN & ELEVATIONS

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 9 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600

BRACKET ASSEMBLY DETAIL

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 10 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600

FRAME BRACKET "A" DETAIL

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 11 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

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VITROS 4600

FLOOR BRACKET "B" DETAIL

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 12 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600

ATTACHMENT DETAIL TO CONC FILL OVER METAL DECK

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 13 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

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VITROS 4600

ATTACHMENT DETAIL TO CONC FILL OVER METAL DECK

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 14 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600

ATTACHMENT DETAIL TO CONC SLAB

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

PLAN AND ELEVATIONS

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

FRONT BRACKET ASSEMBLY DETAIL

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

FRONT FRAME BRACKET "C" DETAIL

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

FRONT FLOOR BRACKET "D"

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

REAR BRACKET ASSEMBLY DETAIL

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

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VITROS 4600 AT

REAR FRAME BRACKET "E" DETAIL

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 23: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 24: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 26: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

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VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 28: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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VITROS 4600 AT

ATTACHMENT TO CONCRETE SLAB

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Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015

Page 29: OSHPD PREAPPROVAL OF MANUFACTURER'S · PDF fileProduct Model Number: Vitros 4600 & Vitros 4600 AT General Description: ... TR UCT R A L. No. S4346 S T A T E OFCALIF O R N I A R E G

VITROS 4600 & 4600 AT CHEMISTRY SYSTEMS

EQUIPMENT ATTACHMENT

CYS STRUCTURAL ENGINEERS, INC.2495 NATOMAS PARK DRIVE, SUITE 650 TEL (916) 920-2020

SACRAMENTO, CA 95833 www.cyseng.com

SHEET TITLE:

Job No: 13072.03

Date: 1/9/2015

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VITROS 4600 AT

ATTACHMENT DETAIL TO CONCRETE SLAB

01/09/2015 OPM-0106-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 29 of 29

Jeffrey Y. Kikumoto

OPM-0106-13

01/09/2015


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