Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :
ALAT KESEHATAN
Kemasan : Unit
Nama Produsen / Pabrikan : BEIJING WANDONG MEDICAL TECHNOLOGY CO., LTD., China
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 01 April 2023.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
4. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
5. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
Wandong Products Specification
#3, No.9, Jiuxianqiaodong Road, Chaoyang District, Beijing 100015, P.R. China
E-mail: international@wandong.com.cn Tel/Fax: +86-10-84575792/3/5, 84575794
KEMENKES RI AKL
DISTRIBUTOR OLEH PT. HOSPI NIAGA UTAMA
Wandong Products Specification
WANDONG MEDICAL
Wandong Products Specification
Reasonable maintenance cost, hardware & software upgrading service and 10 years’ spare parts guarantee.
NEW ORIENTAL 1000 Universal FPD-DR is a combination of digital flat panel imaging and classical radiographic
mechanical structure. The system fits for most common clinical applications of Radiography in both vertical and
horizontal projections, as well as chest examinations, greatly enhance patient throughput
Absolutely, your filmless workflow will be more convenient and faster than conventional radiographic process.
Patients also benefit from low radiation and smooth-running procedures. In addition, the administration of your
medical facility will appreciate NEW ORIENTAL 1000’s streamlines cost-effective processes and high quality
results.
NEW ORIENTAL 1000 is DICOM 3.0 compliance that means you can benefit from all relevant DICOM services,
including DICOM worklist, image storage, printing and other functions will significantly improve your workflow.
WANDONG MEDICAL
Wandong Products Specification
WANDONG MEDICAL
Wandong Products Specification
WANDONG MEDICAL
Wandong Products Specification
I. Configurations:
Standard Configurations:
No. Component Part Number Manufacturer Quantity
1 High Frequency Generator GFS501-1 WDM 1
2 DR Flat Panel Detector WDF 4343RWi WDM 1
3 X-ray Tube Assembly E7876X TOSHIBA 1
4 Collimator XS1-4 WDM 1
5 Radiographic Table SC4-5 WDM 1
6 Chest Bucky Stand LS-6 WDM 1
7 High-density Aluminum Grid JPI JPI 2
8 HV cable DL7512-1B WDM 1
Computer
9 Image Acquisition System 24” Monochrome LCD monitor WDM 1
WD-ACQUIRE v2.0
10 Intercom System F197.FJ.10 WDM 1
11 Console F821.1A WDM 1
Optional Components:
WANDONG MEDICAL
Wandong Products Specification
Component Specifications
WANDONG MEDICAL
Wandong Products Specification
WANDONG MEDICAL
Wandong Products Specification
Hardware configurations:
CPU: Intel Core 2 Duo ≥3.7GHz
Memory: 4GB, Hard Disk: ≥500GB, CD-ROM: DVD Burning
System Interface: USB, Standard RS232, LPT, 100MB network Interface, DVI/VGA Display
Output Interface
Monitor: 24” Monochrome LCD Monitor, Resolution: 1920×1200
OS: Windows 7 or later
Software: WD-ACQUIRE
Image Acquisition: Acquisition condition setting, mechanical position setting, APR
setting.
Enhance Filter: According to different physiological structure of body parts and different
diagnostic request of doctors and different clinical demands, algorithms are optimized
towards different body parts.
Image Acquisition Image processing: Window width/ level, Auto window width/ level setting, preview,
System preset Window width/ level, positive and negative image reversal; Image flipping,
rotating, zooming, roaming; Image interpolation edge enhancement, restore original
image annotation, Character/ number annotation 、 image annotation, Tape
measurement, area measurement, auto-sub-setting.
Image Printing: DICOM Printing, Paper Printing, Manually Select Images Displayed for
Printing, One-key Printing of Annotated Images, various printing equipment compatible,
Printing in film format, Number of printing, Print Queue Control, Stop/ Start Presetting.
Personalized settings: format and layout, default settings, toolbar settings.
Other functions: Users can define a display format or layout; various methods can be
used to view the images of patients, and the way to look up information can be defined.
Reservation function, pixel optimization, the software interface of image processing in
diagnostic workstation is in English, supports high-speed transfer of lossless
compression, support online decompression.
WANDONG MEDICAL
Wandong Products Specification
Optional Components
Component Specifications
WANDONG MEDICAL
Wandong Products Specification
Tube Stand
WANDONG MEDICAL
Product nameplate
2.Packing Box Drawing
New Oriental 1000 System Packing Box