oshpd preapproval of manufacturer's certification … 12/01/2016 opm-0216-13: reviewed for code...

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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 10/22/14) Page 1 of 2 APPLICATION FOR OSHPD PREAPPROVAL OF MANUFACTURER’S CERTIFICATION (OPM) OFFICE USE ONLY APPLICATION #: OPM-0216-13 OSHPD Preapproval of Manufacturer’s Certification (OPM) Type: New Renewal Update to Pre-CBC 2013 OPA Number: 2417-07 Manufacturer Information Manufacturer: IMRIS, Inc. Manufacturer’s Technical Representative: Meir Dahan Mailing Address: 5101 Shady Oak Road, Minnetonka, MN 55343 Telephone: (763) 203-6306 Email: [email protected] Product Information Product Name: IMRIS Skyra and Aera Magnet and Magnet Mover Systems Product Type: MRI Scanner Product Model Number: MR30 (3T MR) and MR15 (1.5T MR) General Description: Overhead mounted rail and transport system that adapts a convention floor-mounted MRI scanner and allows travel in and out of an operating room. The system provides on-demand high resolution MR images during surgery. Applicant Information Applicant Company Name: IMRIS, Inc. Contact Person: Meir Dahan Mailing Address: 5101 Shady Oak Road, Minnetonka, MN 55343 Telephone: (763) 203-6306 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: April 1, 2015 Title: EVP R&D/CTO Company Name: IMRIS, Inc. 12/01/2016 OPM-0216-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 15 e e e ) ) g g e ) g g d d d d a a r a a r n o r r n o o a a g a d g n R) ) e a a e a a ed rail a t a e n n ed n a g n d a g d d g d n d r g d n n n ra n ra r t d n d a ro t d e o il and tr e o l and tra M t M and tra M and tra M M and tran a a nd tran a a nd trans g n nd trans g n g d trans n g d transp d n transp n d d transpo e transpo e ranspo t M t anspor t M ansport M M nsport M nsport M a sport s M a sport s o g sport sy o g port sy g v port sys n v ort sys ve n ort sys e rt syst e e rt syste r e t syste t syste t S t S system S S system S M ystem y M ystem y M ystem s M stem t s o stem th t o tem th te v em th e v em tha e v em tha m e m that m e m that m m that s r s that a s s that a S S that ad S S hat ad S hat ada y at ada y at ada ys at adap s m p t s m t t m ts a e s a e a s d m a d m n a d m a a m a s p s p m p m t m s a s a a a n a a d MR15 (1.5T MR) d il dt t t th t d om. The system provides on - de m. oo e om m. T Th e dM Ma ove r Sy gnet M Emai mdahan@ era Mag T MR mounted rail and transport system that adapts a conve erating nd high at M il: han@ er 3T mounted rail and transport system that adapts a conve pe gh agn R) ted rail and transport system that adapts a ng n oun on MR a M M ma il: md rat hi i Jeffrey Jeffre Y. Y Kikumoto Kik moto OPM-0216-13 12/01/2016 system provides o system provides o

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Page 1: OSHPD PREAPPROVAL OF MANUFACTURER'S CERTIFICATION … 12/01/2016 OPM-0216-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 15 e) g d a r n o ra g d n R)) e ed rail aa

OFFICE OF STATEWIDE HEALTH PLANNING AND DEVELOPMENTFACILITIES DEVELOPMENT DIVISION

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

STATE OF CALIFORNIA – HEALTH AND HUMAN SERVICES AGENCYOSH-FD-700 (REV 10/22/14) Page 1 of 2

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

OFFICE USE ONLY

APPLICATION #: OPM-0216-13

OSHPD Preapproval of Manufacturer’s Certification (OPM)

Type: New Renewal Update to Pre-CBC 2013 OPA Number: 2417-07

Manufacturer Information

Manufacturer: IMRIS, Inc.

Manufacturer’s Technical Representative: Meir Dahan

Mailing Address: 5101 Shady Oak Road, Minnetonka, MN 55343

Telephone: (763) 203-6306 Email: [email protected]

Product Information

Product Name: IMRIS Skyra and Aera Magnet and Magnet Mover Systems

Product Type: MRI Scanner

Product Model Number: MR30 (3T MR) and MR15 (1.5T MR)

General Description: Overhead mounted rail and transport system that adapts a convention floor-mounted MRI scanner

and allows travel in and out of an operating room. The system provides on-demand high resolution MR images during

surgery.

Applicant Information

Applicant Company Name: IMRIS, Inc.

Contact Person: Meir Dahan

Mailing Address: 5101 Shady Oak Road, Minnetonka, MN 55343

Telephone: (763) 203-6306 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: April 1, 2015

Title: EVP R&D/CTO Company Name: IMRIS, Inc.

12/01/2016 OPM-0216-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 15

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Page 2: OSHPD PREAPPROVAL OF MANUFACTURER'S CERTIFICATION … 12/01/2016 OPM-0216-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 1 of 15 e) g d a r n o ra g d n R)) e ed rail aa

OFFICE OF STATEWIDE HEALTH PLANNING AND DEVELOPMENTFACILITIES DEVELOPMENT DIVISION

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

Registered Design Professional Preparing Engineering Recommendations

Company Name:

Button Engineering

Name: Martin Button, Ph.D., P.E. California License Number: C 34396

Mailing Address: 4701 Shoal Creek Blvd., Austin, TX 78756

Telephone: (512) 452-0628 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): Shake table testing (2011) of earlier model of MR30 / MR15 together with analysis and

qualification of differences, in accordance with the Design / Analysis Criteria document accompanying this application.

*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): Design of typical rail beams andtheir attachment to the structure will be in accordance with ASCE 7-10 and AISC 341-10.

List of Attachments Supporting the Manufacturer’s Certification

Test Report Drawings Calculations Manufacturer’s Catalog

Other(s) (Please Specify): Design / Analysis Criteria document for OSHPD review and approval. Once the

Design / Analysis Criteria is approved, calcs and drawings will be submitted to support the Manufacturer’s Certification.

OFFICE USE ONLY – OSHPD APPROVAL VALID FOR CBC 2013 ONLY

Signature: Date: 12-01-2016

Print Name: Jeffrey Kikumoto

Title: SSE

Condition of Approval (if applicable):

STATE OF CALIFORNIA – HEALTH AND HUMAN SERVICES AGENCYOSH-FD-700 (REV 10/22/14) Page 2 of 2

12/01/2016 OPM-0216-13: Reviewed for Code Compliance by Jeffrey Kikumoto Page 2 of 15

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