aay Atomic wut Energy 7 fare Regulatory . ms afag Board eS 25 Yearsof ; Safety Regulation 1983 - 2008 GOVERNMENT OF INDIA Tee CHAIRMAN . Page 1/23 AERBIA45/TACIMDX/ 02 /R-11/2009 ~ TIGO_ “june 08, 2009 ea 'S0 9001:2000 ‘Organisation Renewal of Type Approval Certificate for Medical Diagnostic X-ray Units Manufactured by Mis. ‘Siemens Ltd, Goa Mis. Siemens Ltd , Goa are hereby informed that the Atomic Energy Regulatory Board (AERB) renews the type approval for their medical diagnostic X-ray units as detailed in Table -1 ( Pagés 2 to 23 ) of this certificate for manufacture , supply and installation in India ‘This renewal of type approval is valid til April 15, 2011. ‘This renewal of type approval becomes invalid if any change is made in the approved model of medical diagnostic X-ray unit /s Siemens Lid , Goa shall maintain complete records of qualily assurance (QA) for each mode! ‘of medical diagnostic X-ray units... Such records shall be made available for Inspection. M/s Siemens Ltd , Goa shall be responsible for carrying out quality assurance and surveillance in diagnostic radiology as specified in the Field Data Form AERB/RSD/TAY X-ay -2006 of the X-ray unit prior to handing over the unit to the customer. fW/s Siemens Lid, Goa shall get the registration form attached with this certificate duly filled in by the customer and forward the same fo AERB immediately after instalation of the X-ray unit at each customer's institution. Mis Siemens Ltd, Goa shall keep AERB informed in the months of January April, July and October every year about the supply , servicing and maintenance of the approved modet of medical diagnostic X-ray unit. ‘The supply of approved model of medical diagnostic X-ray unit after expiry of this approval is conditional upan the revalidation of the BIS certificate as well as AERB approval Mis Siemens Ltd , Goa shall affix AERB certification marks shown in column 1 of Table —1(e.9 ‘AERB/ 02/ 007 ) of this certificate, on the X-ray tube head assembly, X-ray control panel and X-ray Generator prominently and permanently for approved model of medical diagnostic X-ray units prior to supply. A copy of this certificate shall be provided to the user when the medical diagnostic X-ray unit is supplied. =e b= Legato putbonky Sey einer me _ ee /5 SHARMA (Chief Manager , Quality and Regulatory affairs ) ery cel Prarie whee Siemens Ltd L-6, Verna Industrial Estate Atomic Enersy Regulatory Board Verna —Goa 403722 EE Premera, sepFerrre, set - 400.004 ‘yom / TELEPHONE : 01-22-2556 2949, 2599 0604 NIVAMAK BHAVAN, ANUSHAKTI NAGAR, MUMBAI - 409 094 Ape / FAX ; 91-22-2556 2544, 2860 6717, 2558 9200 E-mail; chalrman@aerb.gov. erage / WEBSITE : wiew.aorb.gov.inTem oof Pare uReg ATOMIC ENERGY REGULATORY BOARD Page 2 /23 dated June 08, 2009 AERB/445/TACIMOXIO2A/574-679/2009 ‘Tablo-1; Details of the medical dlagnostle x-ray units manufactured by M/s. Siemens Limited (SL), Goa SP AERB Woda! & [ Deiais of the Xray | Dolails of the generator” | Special condition No. | cottification Mode lube, Xray lube head | Table/ stand mark assembly PEELE 7 | AERSIO2AI574 | Multimobi-2.6 | OX/110-1 X-ray tube | Mullipulse, Single phase, (6808/5807) | manufactured by M/s. | Maximum’ rated current | 15510) CEI, lay. Tube 60 mA. and maximum Radiogrephy | housing manufactured | rated potential 100 kVp. (Mobile) by Mis. Siemens Limited, Goa. Total {iiation 2.5 mm Al Z| RERBIODAISTS | Multmobi-70 ['X-20 X-ray tube Wulipuise, Single phase, (6354)5454) | manufactured by M/s. | Maximum’ rated current Radiography | YE, Italy. Tube 460 mA and maximum Mobile housing manufactured | rated potential 125 kVp. by Mis, Siomens Limited, Goa. Total ae fication 3.5 mm Al J [37] AERBIO2ASTE | Mulliphos-18 | DRA-1-125/20/40 X- | Malipulse, Three phase, \ (6602) ‘ray tube with housing | Multix Basie table (6502) Radiography |-manufactured by Ws | Maximum rated current ‘manufactured by M/s, ) 200 mA and maximum BEL, Pune. Total | rated potential 125 kVp, fitralion 4.0 mm AL TT RERBTORNTETT —inamnphosAE [Two tubes of PRAT | Mailipulss, Thee | Fluoroseepy (602) 125720140 X-ray tube | phase, Polyskopsl table | curent shall Radiography | with THX-1-120/80 | (506) Maximum rated | not exceed 2.5 and tube housing furrent 200" mA and | mA al 90 kVp | Fluoroscopy | manufactured by Ws. | maximum cated potential | for tabletop BEL, Puno. Total | 4125KVp. distance of 44 fiyalion 4.9 rm A em. S| RERBORRETE | WaaTIphOSAS | Two lubes of DRA | Wallipulss, Thies | Fluoroscopy (5502) 128120140 X-ray tube | phase, Klneskop-H table | current shall not | Radiography | with THX-1-12680 | (6245). Maximum rated | exceed 2.5 mA | and tube housing current 200 mA and | at 90 kVp for Fluoroscopy | manufactured by Mis. | maximum rated potential | tabletop BEL,Pune. Total | 125%Vp. distance of 41 fillcalion 4.0 mm Al cm TT REREWOZAISTS | Matiphos-16 | Two tubes of ORAT- | Wullipulse, Three phase, [Fluoroscopy | (6602) 4125/20/40 X-ray tube | Klinoskop-H table (5245) | current shall Radiography | with THX-1-125/80 | and Fluorovision-2000 | not exceod 2.5 and tube housing ‘Maximum rated current | mA at 80. kVp Fluoroscopy | manufactured by Mls. | 200 mA and maximum | for tabletop Fixed. BEL, Pune, Toll — | rated potential 125 kVp. | distance of 41 with 7° 0rTV. —_{ fitraiion 4,0 mm AL om cémpetent Authority Wa. wat /S.K. SHARMA seat Chairman weary st Pras WN ‘omic tioror Regustory oad