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 : PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Netherlands
Untuk PHILIPS HEALTHCARE (SUZHOU) CO., LTD., China
Nama Pendaftar : PT. PHILIPS INDONESIA COMMERCIAL, DKI Jakarta
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 03 Mei 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. Izin edar ini merupakan persetujuan perbaikan nama dagang dan perubahan lampiran dari Nomor
Izin Edar Alat Kesehatan KEMENKES RI AKL 21501816716 tanggal 23 September 2019. Dengan
demikian izin edar sebelumnya dinyatakan tidak berlaku.
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persetujuan izin edar ini.
6. 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.
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203
LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 21501816716
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini
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.
Prodiva1.5TCX
Prodiva1.5TCX
Ref:781070
NomorSeri:lihatpenandaanutamaberbahasaInggris
Diproduksioleh:
PhilipsMedicalSystemsNederlandB.V.
Veenpluis6,5684PCBest,TheNetherlands
Untuk
PhilipsHealthcare(Suzhou)Co.,Ltd.
No.258ZhongYuanRoad,SuzhouIndustrialPark
215024Suzhou,JiangsuProvince,P.R.China
Diimpordandidistribusikanoleh:
PTPhilipsIndonesiaCommercial
GedungCibisNineLantai10
Jl.TBSimatupangNo.2,Jakarta12560,Indonesia
KEMENKESRIAKL
Ingenia
Prodiva 1.5T CX
MR Systems
Prodiva1.5TCX
Ref:781070
NomorSeri:lihatpenandaanutamaberbahasaInggris
Diproduksioleh:
PhilipsMedicalSystemsNederlandB.V.
Veenpluis6,5684PCBest,TheNetherlands
Untuk
PhilipsHealthcare(Suzhou)Co.,Ltd.
No.258ZhongYuanRoad,SuzhouIndustrialPark
215024Suzhou,JiangsuProvince,P.R.China
Diimpordandidistribusikanoleh:
PTPhilipsIndonesiaCommercial
GedungCibisNineLantai10
Jl.TBSimatupangNo.2,Jakarta12560,Indonesia
KEMENKESRIAKL
For too long, the perception of MR has been that it’s a time-consuming, anxiety-
inducing experience only appropriate for a limited patient population. At Philips,
we’re committed to partnering with you to deliver a confident diagnosis the first
time, while also helping to future-proof your radiology department. We do this by
leveraging our deep insights into the people behind the image. This has culminated
in our all new Ingenia integrated MR solutions, which break down diagnostic
boundaries to empower a faster, smarter, and simpler path to confident diagnosis,
elevating the patient experience and, above all, helping to improve patient care.
2
Content
Ingenia Prodiva CX 2
Magnet system 4
Gradient system 6
RF system 8
Patient comfort 12
Computer systems 18
Siting 21
3
4
Ingenia Prodiva CX
A revolutionary workflow delivers
speed - and productivity
1. Based on internal study comparing workflow in a mix of Brain, Spine, MSK and Body applications with Achieva. 5
Ingenia Prodiva CX magnet system
Type
Field strength 1.5 T
Frequency 63.86 MHz
Magnet design Ultra compact, lightweight
Magnet dimensions, (LxWxH) 1598 * 1777 * 2012 mm
Magnet weight (with cryogen) 2700 kg (±2%)
Magnet Length (without cover) 1.60 m
Bore design 60 cm
Fringe field 5 G (radial x axial) 2.3 * 3.5 m
Fringe field 1 G (radial x axial) 3.3 x 5.2 m
Temporal stability Guaranteed: < 0.1 ppm/hr
Transportation dimensions Minimum: 2.07 m (81 inch.)
Typical: >2.3 m (91 inch.)
System weight (magnet with cryogen, electronics, 3813 kg (±2%)
gradient and body coils, including covers, patient
support and integrated posterior coils)
Homogeneity
Field homogeneity Typical2 (ppm, V-RMS) Guaranteed3 (ppm, V-RMS)
50 * 50 * 45 cm )4 )4.6
45 cm DSV ) 2.3 ) 2.8
40 cm DSV ) 0.9 ) 1.1
30 cm DSV ) 0.18 ) 0.22
20 cm DSV ) 0.051 ) 0.063
10 cm DSV ) 0.012 ) 0.015
6
Shimming
Type of shimming Both passive and active shimming. Passive shimming
during installation. Automatic active shim (auto-
shim) or dynamic FOV shimming for each patient.
Patient specific shimming 3D Volume Shim
First order shimming 3x linear
Shielding
Magnet shielding Active self-shielding
External Interference shielding Yes
Cryogenics
Type of cryogen Liquid He
HeliumSave technology Yes (Zero boil-off)
Cryogen boil-off rate 0.0 l/hr*
Cryogen refill interval Not applicable
Vessel capacity (liters) 1325
1. Normal operation is defined as typical scanning performed with uninterrupted availability of electricity,
magnet cooling and excluding service actions.
2. All typical values are an average of multiple MR systems measured.
3. Prodiva uses 24 planes / 24 points per plane measurement method.
7
Ingenia Prodiva CX gradient system
8
Parameters 2D (ms) 3D (ms)
Sequence Matrix Min TE Min TR Min ESP Min ESP Min TE Min TR Min ESP Min
(SE) (Gr) (SE) ESP (Gr)
SE 64 2.97 9.04 4.64 8.14
128 3.04 9.23 4.65 8.19
256 3.14 9.53 4.72 8.51
TSE 64 1.7 8.88 1.7 4.41 8.96 4.41
128 1.75 8.88 1.75 4.45 8.91 4.45
256 2.2 8.88 2.2 4.7 8.67 4.7
IR 64 3.68 28.23 5.61 29.08
128 3.74 28.23 5.62 29.08
256 3.86 28.23 5.69 29.08
Ssh TSE 64 3.4 1.7 4.9
128 3.9 1.81 4.9
256 4.9 2.27 5.4
FFE / TFE 64 0.29 0.8 0.23 0.8
128 0.38 1.01 0.31 0.82
256 0.5 1.34 0.44 1.14
GRASE 64 3.76 15.32 3.76 0.425 6.75 24.82 6.75 0.425
128 3.95 16.09 3.95 0.472 6.99 25.72 6.99 0.472
256 5.28 20.66 5.28 0.824 8.32 30.63 8.32 0.824
FFE-EPI 64 0.98 2.64 0.301 0.92 2.44 0.301
128 1.09 2.89 0.424 1.03 2.69 0.424
256 1.52 4.38 0.731 1.46 4.18 0.731
Ssh EPI 64 2.6 0.325
128 3.3 0.458
256 8 0.731
SE-EPI 64 6.53 19.99 0.3 10.19 24.06 0.3
128 13.2 44.35 0.424 16.76 48.31 0.424
256 40.19 138.2 0.731 43.74 141.88 0.731
DWI (b1000) 64 61.86
128 63.07
256 67.12
Notes: The Prodiva CX can perform all of the sequences mentioned above with matrix sizes from 64 to 1024. This table is limited to commonly used
matrices. A combination of the stated parameters is not always possible; some parameters may require optional packages. Scan parameters are
compliant with I.E.C. regulations.
9
Enhance your clinical perfomance
with digital technology
11
Enhance your throughput
with simplified, highly guided Breeze3 Workflow
Breeze Workflow
12
Standard coil solutions
Coil solution TotalNeuro Head/ Neck
* = option
13
Patient comfort
Patient comfort is at the center of
Ingenia Prodiva CX’s design
Patient comfort
Patient comfort is enhanced by:
• An open and appealing compact system design
• Low patient table step up height
• Large open NeuroVascular coil for open face imaging
• Elevated head coil providing a natural
tilt with respect to the Spine coil
• Head and feet first imaging
• Lightweight anatomy conforming anterior coils
• Mirror providing open visual field
• Acoustic noise reduction measures
• Patient adaptive imaging techniques for
various challenging patient conditions
• Bi-directional communication with the operator
Patient comfort
Bore Design 60 cm
Flare at both ends Yes
Viewing angle at ISO center 48.8 degree
Diameter of the max. flare 148 cm
In-bore lighting 3 levels
Fresh air supply 6 levels
Patient Table
Horizontal travel
Distance 278 cm
Speed Three speeds: 20, 80, 180 mm/sec
Vertical travel
Speed 26 mm/s
Travel time from lowest position 10 s
Max weight capacity 200 kg (441 lbs)
(including posterior coils and accessories)
Max patient weight 175 kg (386 lbs)
(excluding embedded coils and accessories)
Table accuracy (reproducibility): ) +-0.5 mm
Min. table height Table edge: 52 cm (20.5 inch)
Table center: 47 cm (18.5 inch)
Table height at working position Table edge: 78.6 cm (30.9 inch)
Table center: 73.6 cm (29 inch)
Table controls Left and right sides
4
Max. imaging coverage 190 cm
14 4. Recommended siting requirements need to be met for full usage of horizontal table movement.
Patient communication
AutoVoice Automated breathhold guidance aligned with the patients’ respiratory cycle
Scan duration information
Table movement announcements
Enabling quick language selection, to adapt while scanning
AutoVoice language Selection of 30 languages
Fully customizable by recording specific languages
Patient communication
Communication system allows for two-way intercom communication with the patient and includes a nurse
call button. Optional camera and monitor are available (up to 4 cameras can be connected).
15
16
A smart way
to standardize your examinations
17
Physiology measurement and gating
Wireless physiological hardware to provide synchronization
for sequence triggering and gating. Wireless physiological
signals can be observed on the operator's console monitor.
• Wireless Physiology consisting of wireless Basic Triggering
Unit (wBTU) and respiratory module hardware
• Physiological synchronization for sequence triggering and
gating through
- Wireless VCG
- Wireless Respiratory
- Wireless PPU
Physiology synchronization
Signal type (standard) Vector ECG (VCG),
Respiratory and
Peripheral Pulse
18
19
Ingenia Prodiva CX
Computer systems
20
Connectivity/interoperability • DICOM MR:
Communication is performed via DICOM protocols. • Export/Import of DICOM MR Images
The system can be configured for safe storage of • Export/Import of Philips Private MR Series Data
MR images and other patient data in departmental • Export/Import of Philips Private MR Spectrum Data
information systems and PACS. The MR workspace • Export/Import of Philips Private MR ExamCards Data
conforms to the Enhanced (multi-frame) MR DICOM • DICOM SC:
standard, which improves the performance of data • Export/Import of SC (color) Image Data
transfer of large data sets and fully supports information • DICOM Grayscale Softcopy Presentation State:
associated with diffusion and spectroscopy. • Export/Import of Grayscale Softcopy Presentation State
• DICOM Query / Retrieve of Philips MR data,
The system can be configured (per node) to support all the exported image types.
standard DICOM MR image transfer or DICOM • DICOM Print
Enhanced MR Image Transfer. If a receiving node • Grayscale Softcopy Presentation State with
does not support DICOM Enhanced MR, standard preset window settings as on the console
DICOM MR Images will be transferred. • Basic Grayscale Print
• DICOM Media
• DICOM Workflow Management: • MR Studies on DVD (Read/Write)
• DICOM Modality Worklist • IHE Integration Profiles
• DICOM Modality Performed Procedure Steps • Scheduled Workflow
• DICOM Storage Commitment • Patient Information Reconciliation
• DICOM Send/Receive: • Consistent Presentation of Images
• DICOM Enhanced MR: • Basic Security
• Export/Import of DICOM Enhanced MR Images • Consistent Time
• Export/Import of DICOM MR Spectroscopy
• Export/Import of DICOM Raw
Full information on compliance with DICOM
standards and available functionality is contained
in Philips’ DICOM Conformance Statement.
21
22
Enhance the value of
your investment
with predictable and low total cost of ownership
The initial cost of your MR system is just one aspect that contributes to a profitable
investment. Our integral approach to cost control, easy installation and proactive
support is designed to help you control costs and get a greater return on investments.
Siting specifications
Siting requirement
Minimal total siting requirement 25 m2
(Exam room + Control
room + Technical room
23
24
25
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