Post on 18-Jan-2023
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950Telepon : (021) 5201590 Pesawat 2029, 8011Faksimile : (021) 52964838 Kotak Pos : 203
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.
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 diberikanpersetujuan untuk diedarkan dengan :
NOMOR IZIN EDAR
A L A T K E S E H A T A N
KEMENKES RI AKL 21501122428
Nama Dagang / Merek : PHILIPS Azurion 7 B20/15
Kelompok / Kelas Resiko : Elektromedik Radiasi / C
Kategori Produk : Peralatan Radiologi
Sub Kategori : Peralatan Radiologi Diagnostik
Jenis Produk : Image-intensified fluoroscopic x-ray system.
Tipe / Ukuran : 722226, 722068
Kemasan : Dus, Unit
Nama Produsen / Pabrikan : PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Netherlands
Nama Pendaftar : PT. PHILIPS INDONESIA COMMERCIAL, DKI Jakarta
Atas dasar lisensi dari : -
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 05 Februari 2026.
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 perubahan kode produk dan aksesori dari Nomor Izin Edar
Alat Kesehatan KEMENKES RI AKL 21501816133 tanggal 15 Februari 2021. Dengan demikian
izin edar sebelumnya dinyatakan tidak berlaku.
4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.
Jakarta, 05 April 2021
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950Telepon : (021) 5201590 Pesawat 2029, 8011Faksimile : (021) 52964838 Kotak Pos : 203
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.
LAMPIRAN NOMOR IZIN EDAR
ALAT KESEHATANKEMENKES RI AKL 21501122428
No. Deskripsi Tipe / Kode
1 Additional table accessory rail 4588 012 9567X
2 Anti-scatter grids FD12 9896 010 6943X
3 Anti-scatter grids FD15 9896 010 6905X
4 Anti-scatter grids FD20 9896 010 6904X
5 Anti-scatter grids FD20 (Neuro grid) 9896 010 7372X
6 Set of elbow supports 4598 007 0274X
7 Height-adjustable arm support 4598 007 5211X
8 Shoulder support board 4598 008 2855X
9 Arm support board 4598 007 5903X
10 Arm support board pad for Azurion series 7 4598 011 1022X
11 Cable supports 4598 006 5949X
12 Drip stand 9896 002 0633X
13 Cerebral filter 9896 001 3362X
14 Peripheral X-ray filter 9896 000 3241X
15 Head support 4598 007 4807X
16 Standard mattress for Azurion series 7 4598 011 1020X
17 Cardio mattress for Azurion series 7 4598 011 1021X
18 Neuro mattress for Azurion series 7 4598 011 1023X
19 Mouse table 4598 007 4805X
20 Neuro wedge 4598 007 9790X
21 Pan handle 4598 007 4803X
22 Ratchet compressor 4598 007 2220X
23 Table accessory rail clamps 9896 002 0461X
24 Patient straps 9896 002 0453X
25 Handgrip and clamp set 4598 007 4462X
26 Table-mounted radiation shield 9896 000 7720X
27 Touch screen module swing arm 4598 013 2471X
28 Viewpad Cardio 4598 006 7815X
29 Viewpad Vascular 4598 006 7818X
Lampiran 1 dari 2 Halaman
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950Telepon : (021) 5201590 Pesawat 2029, 8011Faksimile : (021) 52964838 Kotak Pos : 203
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.
No. Deskripsi Tipe / Kode30 Wireless mouse 4598 004 7453X
31 XperGuide laser tool 9896 002 1207X
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yangtercantum dalam lampiran ini
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Lampiran 2 dari 2 Halaman
Jakarta, 05 April 2021
Azurion 7 B20/15
Azurion 7 B20/15Ref: 722226, 722068Nomor Seri: lihat penandaan berbahasa Inggris
Diproduksi oleh:Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC Best, The Netherlands
Diimpor dan didistribusikan oleh:PT Philips Indonesia CommercialGedung Cibis Nine Lantai 10Jl. TB Simatupang No. 2, Jakarta 12560, Indonesia
KEMENKES RI AKL
Azurion 7
Image guided therapy
With Azurion,performance and superior care become one
Azurion 7 B20/15Ref: 722226, 722068Nomor Seri: lihat penandaan berbahasa Inggris
Diproduksi oleh:Philips Medical Systems Nederland B.V. Veenpluis 6, 5684 PC Best, The Netherlands
Diimpor dan didistribusikan oleh:PT Philips Indonesia CommercialGedung Cibis Nine Lantai 10Jl. TB Simatupang No. 2, Jakarta 12560, Indonesia
KEMENKES RI AKL
Azurion enables you to
provide superior care
Azurion helps you
optimize your lab
performance
An easy-to-use platform
supports you in quickly
and easily performing
diverse procedures
This is exemplified by our Image Guided Therapy System Azurion 7. It allows you
to easily and confidently perform a wide range of routine and complex procedures
with a unique user experience, helping you optimize your lab performance and
provide superior care. Azurion is powered by ConnectOS, a real-time multi-
workspot technology designed specifically for the Azurion image guided
therapy platform.
As the interventional space evolves, we continue to integrate essential lab systems
and tools onto the Azurion platform for a better user experience. The Azurion
integrated lab offers a seamless user experience that gives you control of all
compatible applications from a single touch screen at table side, to help make fast
and informed decisions without breaking sterility.
With Azurion’s industry leading image guided therapy platform, we reinforce our
commitment to you and your patients. Our goal is to help you effectively meet
today’s challenges so that you are ready for the future.
Treating patients. It’s what you do.You strive every day to provide the best patient care, quickly and reliably, no matter which procedure you are performing.So try to imagine an increased number of procedures, for more patients, carried out consistently and efficiently with fewer preparation errors. Workflow can be optimized and performed on an intuitive platform designed to make your day a lot easier.
17% reduction of procedure time with Philips Azurion at St. Antonius Hospital.1
The ability to treat one more patient per day today, or in the future
3Image guided therapy | Azurion 2 Image guided therapy | Azurion
Full control at table side to enhance decision making
You can now control all compatible applications in
the interventional lab via the central touch screen
module and FlexVision Pro. Not only does this improve
workflow within the exam room, it helps reduce the
need for team members to leave the sterile area and
walk to the control room during procedures. This can
save time and help avoid delays.
Gain advanced physiologic guidance to help
improve treatment outcomes
You can access IntraSight, a comprehensive suite
of clinically proven2-6 imaging, physiology and co-
registration7 tools, via the central touch screen module.
These tools allow you to go beyond the angiogram
and complete your view of the target vessel, to help
you make fast, informed clinical decisions.
Azurion with FlexArm – more independent control
for physicians
The FlexArm option further evolves Azurion’s table
side control with the intuitive Axsys controller to make
procedures flow naturally and easily. When changes
or complications occur, the physician can quickly and
easily take action. This can also reduce the need to
move in and out of the sterile field during a procedure.
Designed around you and your procedure
All Azurion systems and interventional tools use
the same standardized user interface to support
training. Use has been further simplified through a
sophisticated help function. You can access digital
user guides with one click for on-the-spot assistance.
Clear and simple to use
On screen, information clearly stands out against the
distinctive black background where active applications
are highlighted. Backlit icons and distinctly shaped
buttons on the Control Module promote intuitive
operation. All controls are designed for easy cleaning
to meet stringent sterility requirements.
Less clutter and faster workflow
With the Azurion integrated lab, controlling all
compatible applications at the touch screen module
can reduce extra interfaces and controls table side.
The FlexSpot works according to the same principle.
It gives you access to all compatible applications
in one compact, customizable workplace that can
be placed in the control room or exam room where
needed. Save time by setting the display to re-arrange
and re-size as applications are opened and closed.
At Philips, we are guided by you. With Azurion, we’ve brought the user experience and simplicity of touch screen controls right where it’s needed to make a difference to lab workflow.
Outstandinguser experience 91% of the users think the touch screen module
with multimodality functionality increases the ease of use when switching between compatible applications (e.g., X-ray, iFR/FFR, hemo, etc.) during interventions, compared to their current system(s).7
In a simulation study with 23 users,
4 Image guided therapy | Azurion 5Image guided therapy | Azurion
Azurion’s integrated approach can help you achieve measurable improvements in throughput, cost reduction and staff satisfaction.
Do more at table side
With our enhanced touch screen module, you will
experience simpler, smoother procedures, based on
familiar tablet interactions. For example, you can now
easily mark relevant details on 2D images on the touch
screen with your fingertip.
Azurion allows you to run an entire case without
breaking sterility
The touch screen module offers total control within
the sterile field. Run an entire case table side as you
quickly diagnose, navigate, annotate and measure to
your exact specifications, even when wearing gloves
and under a sterile drape. Table side control saves
you from having to go to the control room to access
applications.
Save time through Instant Parallel Working
The Azurion 7 image guided therapy system has
been specifically designed to save time by enabling
interventional team members to do two tasks at
the same time in the exam room and control room -
without interrupting each other. As an example, while
fluoroscopy/exposure is taking place, a technologist
in the control room can instantly review previous
images from the same patient, prepare the next exam
or finish reporting on another patient. This leads to
higher throughput and faster exam turnover without
compromising quality of care.
Simplify workflow
Enter patient information once and it is automatically
transferred to connected applications to reduce data
entry errors. To save time, IntelliSpace Cardiovascular8
and IntelliSpace Portal launch automatically with the
specific patient on the exam room monitor.
Azurion’s full system automatic position control
(APC) gives you more flexibility to recall the stored
position of the C-arm, table and other parameters for
a particular image to simplify positioning.
Imagine an easier work day
You can combine different user centric workspots
(FlexVision Pro, FlexSpot and touch screen modules)
to view, control and run applications where and when
needed. At these workspots you can co-register9 iFR
or IVUS data with the angiogram, so you have the
tools in hand to manage procedure quality and patient
care. Together these flexible workspots allow you to
customize your workflow to boost efficiency.
Safeguard clinical performance and enhance lab
security over time with Windows 10 platform
The standard Windows 10 platform can help support
compliance with the latest security and standards to
protect patient data. It can also accommodate new
software options to extend your system’s clinical
relevance over time.
With Azurion we help you to optimize your lab performance
FlexSpotTouch screen module Pro FlexVision Pro
In a simulation study with 23 users,
83% of users think the enhanced touch screen module with multimodality functionality will enable faster procedures by reducing staff movements and clicks to use different clinical applications.7
7Image guided therapy | Azurion 6 Image guided therapy | Azurion
Clinical demands are getting more specific. So are we.
Our clinical suites are tailored to meet your specific
challenges, while offering you the flexibility to carry
out procedures in the easiest, most efficient way.
We have a flexible portfolio of integrated technologies
and services to support the full interventional
spectrum. We also offer Hybrid OR solutions that
create an innovative care environment for performing
open and minimally invasive surgical procedures.
Simplified set-up and operation
The Azurion 7 uses a range of ProcedureCards to
help optimize and standardize system set-up for all
your cases. The system will automatically select the
appropriate ProcedureCard(s) based on the RIS/HIS/
CIS code of the scheduled procedure.
ProcedureCards can increase the consistency of
exams by offering presets (e.g. most-frequently used,
default protocols and user-specified settings) on the
procedure, physician or department level.
In addition, hospital checklists and/or protocols can be
uploaded into the ProcedureCards to help safeguard
the consistency of interventional procedures and
reduce preparation errors.
Enhance patient care with continuous monitoring
The Philips Interventional Hemodynamic System
is integrated with the IntelliVue X3 patient monitor,
allowing continuous patient monitoring throughout
procedures in the interventional workflow. There is
no need to change cables, minimizing disruption to
vulnerable patients and giving you more time to focus
on them. Continuous patient monitoring also results in
a gap-free patient record.
Azurion enables you to provide superior care
As patient volumes rise and procedures become more complex, how do you maintain high standards of quality and safety in your healthcare facility?
Clinical suites
78% of users think the ease of use of the enhanced touch screen module with multimodality functionality will increase their utilization of different clinical applications in interventional procedures.7
In a simulation study with 23 users,
9Image guided therapy | Azurion 8 Image guided therapy | Azurion
Managing dose efficiently
The Azurion 7 incorporates many DoseWise solutions,
a comprehensive range of radiation dose management
tools, training, and integrated product technologies
that aim to help you take control over patient care,
staff safety, and regulatory compliance. The MRC200+
X-ray tube incorporates SpectraBeam filtration, which
helps maintain image quality at a low dose. The Zero
Dose Positioning function let’s you pan the table,
change table height or field-of-view on your Last
Image Hold (LIH) image. This means you can already
see the effect of moving the table or changing the
field-of-view on your region of interest to prepare
your next run without using fluoroscopy.
Perform standardized quality assurance verifications
in just 5 minutes10
To make it easier for you to routinely perform
consistent verification tests of radiation dose and
image quality, only Philips offers the User Quality
Control Mode (UQCM) tool on its Azurion system.
With this option, you can independently verify and
audit the radiation and image quality related factors of
your Azurion system in a standardized way in just
5 minutes,10 as well as carry out a range of validation
and quality assurance tests.
High quality images at low X-ray dose
Our ClarityIQ X-ray imaging technology provides
superb image quality at significantly lower dose across
clinical areas, patients, and operators.11 In routine
coronary procedures,12 ClarityIQ technology may
reduce patient radiation dose (as total dose-area
product) by 67%13 for the total procedure without
affecting the procedural performance (fluoroscopy
time and number of exposure images) as compared
to equivalent procedures on an Allura Xper system,
as demonstrated in one single-center study.14 For iliac
DSA procedures, one study showed that ClarityIQ
reduces patient dose by 83%,15 while maintaining
equivalent image quality, compared to a system
without ClarityIQ.13
Managing dose across your organization
Philips DoseAware provides real-time feedback in the
exam room so you can immediately adjust working
habits to manage radiation exposure with your staff.
A critical component in providing exceptional patient
care is strong radiation control and management.
We can help you create a comprehensive dose
management program with DoseWise Portal at its
core. This turnkey dose management solution gives
you control over patient dose and staff occupational
dose. It increases transparency across the entire
enterprise and enables you to make data-driven
decisions concerning quality initiatives and radiation
management.
High standards of safety and low radiation exposure
As you look for new radiation dose management strategies to continue to enhance patient and staff safety, while maintaining and enhancing your level of care, we can support you in meeting your goals.
10 Image guided therapy | Azurion 11Image guided therapy | Azurion
Azurion – a comprehensiveimage guided therapy platform
Azurion 7 C/F12
With its 12" Flat Detector, the 7 Series provides high-
resolution imaging over a large field-of-view with
flexible projection capabilities, making it idea for cardiac
interventions. The entire coronary tree can be visualized in
a single view with minimal table panning.
Azurion 7 C/F20
Enhance visibility for diverse cardiac and vascular
procedures with the excellent image quality and broad
coverage of the next generation 20" Flat Detector. This
system supports head-to-toe imaging and patient access
from all sides.
Azurion 7 C20 with FlexArm
Create a Hybrid OR that provides unlimited imaging
flexibility for diverse procedures and exceptional positioning
freedom for medical teams with the Azurion 7 and the next
generation 20" Flat Detector, combined with the ceiling-
mounted FlexArm option. You get a highly cost-effective
environment that is ready for the procedures of the future.
Azurion 7 C20 with FlexMove
Move to a Hybrid OR with confidence, with the Azurion 7
and the next generation 20" Flat Detector, combined with
the ceiling-mounted FlexMove option. FlexMove offers
exceptional workflow flexibility to perform open and
minimally invasive procedures in the same room.
Azurion 7 B12/12
The Azurion 7 biplane system with two 12" Flat Detectors
provides high-resolution imaging and positioning
flexibility to reveal critical anatomical information during
congenital heart and electrophysiology procedures.
Azurion 7 B20/15
Enhance insight and certainty during neuro interventions
with the Azurion 7 biplane system. It pairs a 20" frontal
with a 15" lateral detector.
Azurion 7 B20/12
The Azurion 7 biplane system with a 20" and 12" Flat
Detector provides exceptional clarity of detail and
navigational precision to support a wide range of
challenging cardiac and vascular interventions.
The Azurion 7 integrated lab brings together a range of sophisticated interventional tools, including clinically proven2-6 imaging and physiology tools, advanced hemodynamic measurements and cardiac informatics to support clinical excellence during procedures.
12 13Image guided therapy | Azurion Image guided therapy | Azurion
Best service performance16 enables you to
treat more patients17
Staying on top of today’s complex healthcare
environment is challenging enough without
a constant concern of keeping your systems
up and running smoothly. With Philips, your
operations are protected by the best overall
service engineer performance for imaging
systems according to IMV ServiceTrak for 5
years in a row.16 Philips remotely connected
systems provide 135 more hours of
operational availability per year, enabling you
to treat more patients.17
Professional support helps you deliver
cost-efficient care
To help you fully leverage your financial,
technological and staffing resources and
realize a high return on your investment,
we offer professional support through our
experienced network of over 7,000 field
service engineers, as well as a flexible service
offering that includes:
• Innovative financing solutions tailored to
meet the needs of healthcare organizations
• A broad range of healthcare consulting
programs to help your organization further
enhance the efficiency and efficacy of your
care delivery process
• Philips Healthcare Education, offering
comprehensive learning options designed to
help you meet your needs.
Cost-effectively manage future upgrades
with the Technology Maximizer program
Technology Maximizer is a program that
runs in tandem with your Philips Service
Agreement.18 When you opt into the program,
you receive the latest available software and
hardware19 technology releases for a fraction
of the cost of purchasing them individually.
The Technology Maximizer Plus allows you
to further tailor upgrades to reduce costs. No
need to wait for budget approval. No need to
buy individual upgrades. Just a cost-effective
way to manage ongoing technology upgrades
through your operational budget.
Unlock your potential
Philips Healthcare Education can help unlock
the full potential of your staff, technology and
organization to meet new challenges through
innovative, meaningful and evidence-based
healthcare education. Our comprehensive
clinical, technical and business-related
courses, programs and learning paths are
designed to help you meet the challenges of
controlling costs, streamlining workflow and
improving patient care.
High productivity combined with low cost of ownershipWith Philips, you get the best service performance16 which enables you to treat more patients,17 and professional support to help you deliver cost-efficient care.
135 more hours of operational availability on average, per year, enabling you to treat more patients.17
Philips remotely connected systems provide
15Image guided therapy | Azurion 14 Image guided therapy | Azurion
How to reach usPlease visit www.philips.com/azurionhealthcare@philips.com
© 2020 Koninklijke Philips N.V. All rights reserved. Specifications are subject to change without notice. Trademarks are the property of Koninklijke Philips N.V. or their respective owners.
4522 991 57911 * JUN 2020
1. Results are specific to the institution where they were obtained and may not reflect the results achievable at other institutions.
2. Davies JE, et al. DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Efficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017.
3. Gotberg M, et al., Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve Guided Intervention (IFR-SWEDEHEART): A Multicenter, Prospective, Registry-Based Randomized Clinical Trial. New England Journal of Medicine, epub March 18, 2017.
4. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018.
5. Maehara A, Matsumura M, Ali ZA, Mintz GS, Stone GW. IVUS-guided versus OCT-guided coronary stent implantation. J Am Coll Cardiol Img. 2017;10:1487-1503.
6. Choi K, et al. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC: Cardivascular Interventions. Mar 2019, 4281; DOI: 10.1016/j.jcin.2019.01.227.
7. Results obtained during a Usability Evaluation in the period of May and June 2019. The tests involved 23 clinicians (16 physicians and 7 technologists) from Europe who performed procedures using Azurion 2.1 image guided therapy system in a cardiac
workflow and non-cardiac workflow in a simulated interventional lab environment.
8. It is the user’s responsibility to ensure that Philips network requirements (such as performance, VPN) for IntelliSpace Cardiovascular are met. Note: Automatic same patient launch feature is available only with specific versions of ISCV and ISP.
9. Co-registration tools available within IntraSight 7 configuration via SyncVision.
10. The related tests were performed by 3 users with different background and experience level. The test timings were performed using a frontal plane of an Azurion biplane R2.1 system (FD20/15N, STM-1713 (Dick Bruna), location QL-1).
11. In 28 individual comparative studies, Philips ClarityIQ was associated with reductions in patient radiation exposure.
12. Routine coronary interventions comprise of fluoroscopy and exposure usage.
13. (95% CI of 53%, 77% for all diagnostic and interventional coronary procedures). The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional cardiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task.
14. Results based on total dose area product from a single center prospective controlled randomized study (University Hospital Gent, Belgium) on 122 patients (42 for Allura Xper and 80 for AlluraClarity) undergoing coronary procedures. Of the 122 patients, 102 (83.6%) had a diagnostic procedure without intervention and 51 (41.8%) resulted in a
diagnosis of no coronary disease. Patient radiation exposure was quantified using cumulative dose area product as collected from Radiation Dose Structured Reports and/or Allura Reports. Baseline dose was maintained by configuring both systems to power up with the lowest dose settings as default and default procedure settings for cardio were used. Exam duration and fluoro time was consistent between the systems and an increase in number of exposure images and runs with the AlluraClarity was attributed to the biplane configuration compared to the monoplane configuration of the Allura Xper.
15. Results based on DSA dose area product per frame from a single center prospective randomized study (St. Antonius Hospital, Nieuwegein, Netherlands) on 48 patients. DSA runs for Allura Xper with ClarityIQ and Allura Xper without ClarityIQ were randomly acquired on the same patient under same condition of geometry, field of view and injection protocol. Image quality was based on subjective assessment (side-by-side, equal or superior than the other, blinded review by 5 independent radiologists).
16. IMV ServiceTrak 2018 X-ray Cardiovascular Systems.
17. Data shown is an average, based on the comparison between remotely connected and non-remotely connected systems. Data sample from 2018 for Allura FD and Azurion systems (n=9955).
18. Eligible RightFit Service Agreements are available with Technology Maximizer.
19. Not currently available for ultrasound hardware.
References
16 Informasi TeknisBagian berikut memberikan informasi dan tabel data tentang spesifikasi sistem.
16.1 Persyaratan Lingkungan
Pengoperasian
Kondisi Lingkungan Rentang (Minimum hingga Maksimum)
Suhu sekitar +10°C hingga +30°C (50°F hingga +86°F)
Kelembapan relatif 20% hingga 80%
Tekanan 70 kPa hingga 106 kPa (ketinggian 0 hingga 3000 m)(700 hPa hingga 1060 hPa)
CATATAN Agar udara dapat mengalir ke seluruh kabinet sistem, jangan meletakkan item apa pundi atas kabinet.
Transportasi dan Penyimpanan
Kondisi Lingkungan Rentang (Minimum hingga Maksimum)
Suhu -25°C hingga +70°C (-13°F hingga 158°F)
Kelembapan relatif 5% hingga 95%
Tekanan 70 kPa hingga 110 kPa (ketinggian 0 hingga 3000 m)(700 hPa hingga 1100 hPa)
Standar IP Peralatan
Peralatan Standar IP Perlindungan
Sistem IPX0 Tidak dilindungi
Mouse nirkabel IPX0 Tidak dilindungi
Dudukan meja penyangga pasien IPX1 Perlindungan terhadap tetesan air yang jatuh se-cara vertikal
Bagian atas meja penyangga pasien IPX2 Perlindungan terhadap tetesan air yang jatuh se-cara vertikal bila penutup dimiringkan hingga 15 de-rajat
Viewpad IPX2 Perlindungan terhadap tetesan air yang jatuh se-cara vertikal bila penutup dimiringkan hingga 15 de-rajat
Review Module IPX2 Perlindungan terhadap tetesan air yang jatuh se-cara vertikal bila penutup dimiringkan hingga 15 de-rajat
Pegangan untuk menggeser meja IP03 Perlindungan terhadap semprotan air
Modul kontrol IPX4 Perlindungan terhadap percikan air
Touch screen module IP44 Perlindungan terhadap percikan air
Sakelar tangan sinar-X IP54 Terlindung dari cipratan air dan debu
Foot switch (berkabel dan nirkabel) IPX8 Perlindungan terhadap efek perendaman terus-me-nerus di dalam air
Emisi PanasTabel berikut ini menyediakan informasi tentang emisi panas rata-rata selama penggunaan klinis.
Informasi Teknis Persyaratan Lingkungan
Azurion Rilis 2.1 Petunjuk Penggunaan 320 Philips 4522 203 78624
Peralatan Emisi Panas
Sistem dasar• Monitor ceiling suspension yang memuat satu monitor
besar dan empat monitor kecil di ruang pemeriksaan• Satu stasiun kerja dengan dua monitor kecil di ruang
kontrol
Ruang pemeriksaan: 1900 WSistem monoplane:• Ruang kontrol: 500 W• Ruang teknis: 2400 WSistem biplane:• Ruang kontrol: 700 W• Ruang teknis: 4000 W
Monitor besar tambahan 500 W tambahan
Monitor kecil tambahan 80 W tambahan
Stasiun kerja tambahan 300 W tambahan
16.2 Konfigurasi Sistem sinar-X
Penggunaan X-ray Tube
Sistem Monoplane Nomor Katalog Saat IniNomor Katalog Sebelum-
nya Rakitan X-ray Tube
Azurion 3 M12 722221 722063 MRC 200+ 0508 ROT-GS1003
Azurion 3 M15 722222 722064 MRC 200+ 0407 ROT-GS1004
Azurion 5 M12 722227 - MRC 200+ 0508 ROT-GS1003
Azurion 5 M20 722228 - MRC 200+ 0407 ROT-GS1004
Azurion 7 M12 722223 722078 MRC 200+ 0508 ROT-GS1003
Azurion 7 M20 722224 722079 MRC 200+ 0407 ROT-GS1004
Sistem Biplane No. Katalog Saat IniNo. Katalog Sebe-
lumnyaRakitan X-ray TubeFrontal
Rakitan X-ray TubeLateral
Azurion 7 B12 722225 722067 MRC 200+ 0508ROT-GS 1003
MRC 200+ 0508ROT-GS 1003
Azurion 7 B20 722226 722068 MRC 200+ 0407ROT-GS 1004
MRC 200+ 0508ROT-GS 1003
Opsi FlexArm Nomor Katalog Saat IniNomor Katalog Sebelum-
nya Rakitan X-ray Tube
Azurion 7 M20 722224 722079 MRC 200+ 0407 ROT-GS1008
MRC 200+ 0508 ROT-GS 1003 dan unit pendingin CU 3101
CATATAN Jika sistem telah di-upgrade, X-ray tube yang digunakan mungkin MRC 200 0508 ROT-GS 1003. Perbedaan spesifikasi ditunjukkan di bawah.
Item Spesifikasi
Voltase maksimum Fluoroskopi: 125 kV1
Paparan: 125 kV
Arus tabung maksimum Fokus besar: 1063 mA di 80 kVFokus kecil: 563 mA di 80 kV
Arus tabung untuk fluoroskopi denyut dengan kontrol kisi 10 mA - 200 mA
Informasi Teknis Konfigurasi Sistem sinar-X
Azurion Rilis 2.1 Petunjuk Penggunaan 321 Philips 4522 203 78624
Item Spesifikasi
Kemampuan pemuatan kontinu (di 23°C) 4000 W(MRC 200: 3200 W)
Nilai titik fokus nominal 0,5/0,8 mm (IEC 60336:2005)
Catatan 1: Penggunaan normal adalah 120 kV. Untuk fluoroskopi beban rendah, 125 kV dapat digunakan.
• Maximus ROTALIX Ceramic tube MRC 200+ 0508 ROT-GS 1003 dengan kapasitas penyimpan
panas anode 6,4 MHUeff dan maksimal 45 dan 85 kW beban waktu singkat.
– MRC 200: Kapasitas penyimpanan panas anode 2,4 MHU
• Sakelar kisi pada fluoroskopi denyut
• Rumah tabung ROT-GS 1003 untuk X-ray tube berpendingin oli dengan sakelar pelindung termal
• Penukar panas unit pendingin untuk pendingin paksa yang langsung dan terus-menerus dengan oli
• Kontrol rotor
• Kabel tegangan tinggi
• Bagian penutup
MRC 200+ 0407 ROT-GS 1004 dan unit pendingin CU 3101
CATATAN Jika sistem telah di-upgrade, X-ray tube yang digunakan mungkin MRC 200 0407 ROT-GS 1004. Perbedaan spesifikasi ditunjukkan di bawah.
Item Spesifikasi
Voltase maksimum Fluoroskopi: 125 kV1
Paparan: 125 kV
Arus tabung maksimum Fokus besar: 813 mA di 80 kVFokus kecil: 353 mA di 85 kV
Arus tabung untuk fluoroskopi denyut dengan kontrol kisi 10 mA - 160 mA
Kemampuan pemuatan kontinu (di 23°C) 4000 W(MRC 200: 3200 W)
Nilai titik fokus nominal 0,4/0,7 mm (IEC 60336:2005)
Catatan 1: Penggunaan normal adalah 120 kV. Untuk fluoroskopi beban rendah, 125 kV dapat digunakan.
• Maximus ROTALIX Ceramic tube MRC 200+ 0407 ROT-GS 1004 dengan kapasitas penyimpan
panas anode 6,4 MHUeff dan maksimal 30 dan 65 kW beban waktu singkat
– MRC 200: Kapasitas penyimpanan panas anode 2,4 MHU
• Sakelar kisi pada fluoroskopi denyut
• Rumah tabung ROT-GS 1004 untuk X-ray tube berpendingin oli dengan sakelar pelindung termal
• Penukar panas unit pendingin untuk pendingin paksa yang langsung dan terus-menerus dengan oli
• Kontrol rotor
• Kabel Tegangan Tinggi
• Bagian penutup
MRC 200+ 0407 ROT-GS 1008 dan unit pendingin CU 3101
Item Spesifikasi
Voltase maksimum Fluoroskopi: 125 kV1
Paparan: 125 kV
Arus tabung maksimum Fokus besar: 813 mA di 80 kVFokus kecil: 353 mA di 85 kV
Arus tabung untuk fluoroskopi denyut dengan kontrol kisi 10 mA - 160 mA
Kemampuan pemuatan kontinu (di 23°C) 4000 W
Nilai titik fokus nominal 0,4/0,7 mm (IEC 60336:2005)
Catatan 1: Penggunaan normal adalah 120 kV. Untuk fluoroskopi beban rendah, 125 kV dapat digunakan.
Informasi Teknis Konfigurasi Sistem sinar-X
Azurion Rilis 2.1 Petunjuk Penggunaan 322 Philips 4522 203 78624
• Maximus ROTALIX Ceramic tube MRC 200+ 0407 ROT-GS 1008 dengan kapasitas penyimpan
panas anode 6,4 MHUeff dan maksimal 30 dan 65 kW beban waktu singkat
• Sakelar kisi pada fluoroskopi denyut
• Rumah tabung ROT-GS 1004 untuk X-ray tube berpendingin oli dengan sakelar pelindung termal
• Penukar panas unit pendingin untuk pendingin paksa yang langsung dan terus-menerus dengan oli
• Kontrol rotor
• Kabel Tegangan Tinggi
• Bagian penutup
Rakitan X-ray tube dan kolimator (rakitan sumber sinar-X)
Item Spesifikasi
Faktor beban yang terkait dengan input energi ditentukan maksimumpada anode dalam satu jam bila diterapkan pada voltase X-ray tubenominal
125 kV, 28 mA (3500 W)
Bidang radiasi simetris maksimum MRC 200+ 0407 ROT-GS 1004 35 x 35 cm pada jarak 1 m
MRC 200+ 0508 ROT-GS 1003 28 x 28 cm pada jarak 1 m
MRC 200+ 0407 ROT-GS 1008 35 x 35 cm pada jarak 1 m
16.2.1 Daya Output Tabung
PaparanMRC 200+ 0508 ROT-GS1003
MRC 200+ 0407 ROT-GS1004
MRC 200+ 0407 ROT-GS1008
Daya listrik tertinggi (arustabung sinar-X dan voltasetabung sinar-X menghasil-kan daya listrik tertinggi)
85 kW (125 kV, 680 mA) 65 kW (125 kV, 520 mA) 65 kW (125 kV, 520 mA)
Daya output listrik tertinggipada 100 kV, 0,1 s (arus tab-ung sinar-X)
85 kW (850 mA) 65 kW (650 mA) 65 kW (650 mA)
Voltase tabung sinar-Xmaksimal dan arus tabungsinar-X tertinggi pada vol-tase tersebut
125 kV, 680 mA 125 kV, 520 mA 125 kV, 520 mA
Arus tabung sinar-X maksi-mal dan voltase tabung si-nar-X tertinggi pada arustersebut
1063 mA, 80 kVArus tabung maksimum ti-dak dapat dicapai dengankonfigurasi sistem saat ini.
813 mA, 80 kV 813 mA, 80 kV
Arus tabung sinar-X minimaldan voltase tabung sinar-Xterendah pada arus terse-but
10 mA, 40 kV 10 mA, 40 kV 10 mA, 40 kV
Produk waktu arus terendah(faktor pemuatan pada pro-duk waktu arus terendah)
0,1 mAs (10 mA, 10 ms) 0,1 mAs (10 mA, 10 ms) 0,1 mAs (10 mA, 10 ms)
Catatan: Nilai ±10%.
Fluoroskopi dengan SakelarGrid
MRC 200+ 0508 ROT-GS1003
MRC 200+ 0407 ROT-GS1004
MRC 200+ 0407 ROT-GS1008
Daya listrik tertinggi (arustabung sinar-X dan voltasetabung sinar-X menghasil-kan daya listrik tertinggi)
25 kW (125 kV, 200 mA) 20 kW (125 kV, 160 mA) 20 kW (125 kV, 160 mA)
Daya output listrik tertinggipada 100 kV, 0,1 s (arus tab-ung sinar-X)
20 kW (200 mA) 16 kW (160 mA) 16 kW (160 mA)
Informasi Teknis Konfigurasi Sistem sinar-X
Azurion Rilis 2.1 Petunjuk Penggunaan 323 Philips 4522 203 78624
Fluoroskopi dengan SakelarGrid
MRC 200+ 0508 ROT-GS1003
MRC 200+ 0407 ROT-GS1004
MRC 200+ 0407 ROT-GS1008
Voltase tabung sinar-Xmaksimal dan arus tabungsinar-X tertinggi pada vol-tase tersebut
125 kV1, 200 mA 125 kV1, 160 mA 125 kV1, 160 mA
Voltase tabung sinar-X min-imal dan arus tabung sinar-X terendah pada voltasetersebut
40 kV, 10 mA 40 kV, 10 mA 40 kV, 10 mA
Arus tabung sinar-X maksi-mal dan voltase tabung si-nar-X tertinggi pada arustersebut
200 mA, 125 kV 160 mA, 125 kV 160 mA, 125 kV
Arus tabung sinar-X minimaldan voltase tabung sinar-Xterendah pada arus terse-but
10 mA, 40 kV 10 mA, 40 kV 10 mA, 40 kV
Produk waktu arus terendah(faktor pemuatan pada pro-duk waktu arus terendah)
0,007 mAs (2 mA, 3,5 ms) 0,007 mAs (2 mA, 3,5 ms) 0,007 mAs (2 mA, 3,5 ms)
Catatan 1: Penggunaan normal adalah 120 kV. Untuk fluoroskopi beban rendah, 125 kV dapat digunakan.Catatan umum:• Nilai ±10%.• Fluoroskopi hanya tersedia dalam mode fluoroskopi denyut.
16.2.2 Akurasi Indikasi Dosimetri dan Sistem Kontrol Otomatis
Indikasi Dosimetrik Akurasi
Akurasi air kerma referensi ±35% (di atas 100 mGy)
Akurasi laju air kerma referensi ±35% (di atas 6 mGy/mnt)
Akurasi dose area product kumulatif ±35% (di atas 2,5 Gy cm2)
Koefisien variasi sistem kontrol otomatis <0,05
Indikasi dosimetri untuk air kerma (rate) referensi dan dose area product kumulatif dihitung
menggunakan parameter pemerolehan dan prosedur kalibrasi dengan dose meter referensi dalam
peralatan. Saat digunakan dose area product meter opsional, indikasi dosis berasal langsung dari alat
ini.
Semua nilai air kerma (laju) referensi yang diberikan memiliki akurasi ±35%, sesuai dengan IEC
60601-2-43:2010, 203.6.4.5.
16.3 Generator X-ray
Data Teknis Sesuai Dengan IEC 60601-2-54Bagian ini berisi informasi khusus generator sinar-X. Informasi tentang penggunaan khusus sistem
generator sinar-X dijelaskan di bagian berikutnya.
Metode Pengukuran
Item Metode
Voltase X-ray tube Voltase tabung diukur dengan bantuan bleeder voltase tinggi pengimbang di sirkuit tegan-gan tinggi
Informasi Teknis Generator X-ray
Azurion Rilis 2.1 Petunjuk Penggunaan 324 Philips 4522 203 78624
Item Metode
Arus X-ray tube Arus tabung diukur pada sisi katode di sirkuit tegangan tinggi searah dari generator sinar-X
Waktu beban Waktu beban diukur antara tegangan puncak 75% ±7,5% tepi naik tegangan tinggi dan te-gangan puncak 75% ±7,5% tepi turun tegangan tinggi
Produk arus-waktu Produk arus-waktu diukur pada sisi katode di sirkuit tegangan tinggi searah dari generatorHV antara tegangan puncak 75% ±7,5% tepi naik tegangan tinggi dan tegangan puncak 75%±7,5% tepi turun tegangan tinggi
Parameter/Rentang
IEC 60601-2-54 Parameter Output Mode Faktor Beban
§ 201.7.9.2.1.101 a Voltase tabung sinar-X maksimaldan arus tabung sinar-X tertinggipada voltase tersebut
Radiografis (naikturun)
125 kV, 720 mA
§ 201.7.9.2.1.101 b Arus tabung sinar-X maksimal danvoltase tabung sinar-X tertinggi pa-da arus tersebut
Radiografis (naikturun)
1000 mA, 100 kV
§ 201.7.9.2.1.101 c Kombinasi arus X-ray tube dan vol-tase X-ray tube menghasilkan dayaoutput tertinggi
Radiografis (naikturun)
1000 mA, 100 kV
§ 201.7.9.2.1.101 d Daya output konstan tertinggi di 100kV, 0,1s
Radiografis (naikturun)
100 kW, 1000 mA
§ 201.7.9.2.1.101 e Produk waktu arus terendah ataupenggabungan faktor beban men-ghasilkan produk waktu arus teren-dah
Radiografis (naikturun)
0,1 mAs
§ 201.7.9.2.1.101 f Waktu radiasi terpendek nominal(paparan AEC)
AEC tidak tersedia, tidak ada teknik wak-tu foto
§ 201.7.9.2.1.101 f Rentang faktor beban tabung yangdikontrol AEC
AEC Rentang faktor beban tabung diten-tukan oleh X-ray protocol. Rentangmaksimum adalah: 40–125 kV; 10–1000 mA. Toleransi sesuai dengan§203.6.4.3.104.3 dan§203.6.4.3.104.4
Sesuai dengan IEC 60601-2-54 Bagian 201.7.2.7
Data Listrik - Generator
Catu daya Untuk sistem yang menggu-nakan nomor katalog saatini
380 V–480 V ±10%, 50 Hz / 60 Hz, 3 fase, sakelar dan sekr-ing (50 A slow blow) oleh sistem PDU
Untuk sistem yang menggu-nakan nomor katalog sebe-lumnya
400 V–480 V ±10%, 50 Hz / 60 Hz, 3 fasa, sakelar dan sekr-ing (50 A slow blow) oleh sistem PDU
Radiografi Daya voltase maksimum 125 kV
Arus X-ray tube 1000 mA
Daya listrik nominal 100 kW (100 kV, 1000 mA, 0,1 dtk)
Daya listrik maksimum • 100 kW• 1000 mA di 100 kV• 720 mA di 125 kV
Output kontinu 1,5 kW (misalnya, 9 fpm pada 100 kW, 0,1 s)
Pembangkit tegangan tinggi Konverter
Ripel Tegangan DC
Unit pendingin catu daya Unit Pendingin: 230 V ±10%, maksimum 2,5 A, 50 Hz / 60Hz, 1 fasa, sakelar dan sekring oleh sistem PDU
Informasi Teknis Generator X-ray
Azurion Rilis 2.1 Petunjuk Penggunaan 325 Philips 4522 203 78624
Data Listrik - Generator
Siklus tugas Generator dapat digunakan secara terus-menerus sepan-jang batasan daya rata-rata yang dijelaskan di KonfigurasiSistem sinar-X ( page 321) terpenuhi.
Radiografi dengan Kontrol Paparan Otomatis
mAs 0,01 mAs…10 mAs
Waktu pengalihan 3,0 ms…10 ms
Radiografi tanpa Kontrol Paparan Otomatis
Voltase tabung 40 kV…125 kV dapat disesuaikan dengan kelipatan 1 kV atau sesuai dengan urutan kelipatanyang secara kasar sesuai dengan penambahan paparan. Dalam kasus tabung dengan vol-tase maksimum lebih rendah, hal ini dibatasi secara sesuai.
Arus tabung Untuk teknik kV-mA-s dan kV-mAs, ini dapat disesuaikan dengan kelipatan 1
10 m A...1000 mA
Rentang mAs 0,1 mAs…2000 mAs
Dapat disesuaikan dengan kelipatan 1
Waktu paparan 1 ms…16 s
Dapat disesuaikan dengan kelipatan 1
Catatan 1: Kelipatan dapat dipilih pada tingkat sistem
Fluoroskopi denyut dengan Kontrol Kisi
Voltase tabung 40 kV - 125 kV
Arus tabung 10 mA - 200 mA (tergantung konfigurasi tabungnya)
IEC 60601-2-54 Bagian 203.6.4.3.104
Paparan Generator sinar-X Certeray (Rentang Umum Aplikasi)
Performa Certeray Persyaratan Standar
Voltase tabung ± (5%) ± 10%
Produk arus-waktu tabung ± (3% + 0,2 mAs) ± (10% + 0,2 mAs)
Arus tabung ± (3% + 1,0 mA)(Tp > 35 ms)± (8% + 1,0 mA)(1 < Tp < 35 ms)
± 20%
Waktu paparan ± (6% + 0,1 ms) ± (10% + 1 ms)
Tampilan pascapaparan mAs ± (3% + 0,2 mAs)
Tampilan waktu pasca paparan ± (2% + 0,1 ms)
IEC 60601-2-54, Cl.203.6.5Sistem mengadaptasi pengaturan paparan dengan memvariasikan satu atau beberapa faktor beban,
berdasarkan jarak sumber ke gambar dan objek di berkas sinar menggunakan kontrol paparan otomatis.
Grafik berikut menampilkan contoh rentang dan relasi antara faktor beban untuk X-ray protocol
tunggal.
Informasi Teknis Generator X-ray
Azurion Rilis 2.1 Petunjuk Penggunaan 326 Philips 4522 203 78624
Gambar 161 Faktor beban (Koroner Kiri, 15 fps) - lebar denyut dan voltase tabung
Keterangan gambar
1 Voltase tabung (kV)
2 Lebar denyut (ms)
Gambar 162 Faktor beban (Koroner Kiri, 15 fps) - arus dan voltase tabung
Keterangan gambar
1 Voltase tabung (kV)
2 Arus tabung (mA)
KompatibilitasGenerator Tegangan Tinggi Certeray iX kompatibel dengan tabung berikut yang diproduksi oleh Philips
Medical Systems:
• MRC 200+ 0508 ROT-GS 1003
• MRC 200+ 0407 ROT-GS 1004
• MRC 200+ 0407 ROT-GS 1008
LabelUntuk informasi tentang label, lihat Label Peralatan ( page 429).
Informasi Teknis Generator X-ray
Azurion Rilis 2.1 Petunjuk Penggunaan 327 Philips 4522 203 78624
16.4 Kolimator
Item Spesifikasi
Ukuran bidang minimum <2x2 mm pada jarak sumber ke gambar 1 m
Filtrasi inheren (tanpa filter spektrum) Ekuivalen Al 0,2 mm pada 75 kV
Kecepatan operasional celah maksimum pada jarak sumberke gambar 1 m
20 cm/dtk
Kecepatan operasional wedge maksimum pada jarak sum-ber ke gambar 1 m
10 cm/dtk
Kecepatan rotasi operasional wedge maksimum 90 derajat/dtk
Kecepatan rotasi kolimator maksimum (opsi FlexArm saja) 55 derajat/dtk
16.5 Kisi anti-tersebar
Jenis Detektor Tingkat Baris [baris/cm] Rasio Kisi Jarak Titik Fokus [cm]
FD12 N74 r14 f105
FD15 N70 r13 f100
FD20 N44 r12 f105
16.6 Daya Listrik
Sesuai dengan definisi IEC60601-1, sistem diklasifikasi sebagai peralatan kelas I untuk pengoperasian
yang terus-menerus.
Sistem
Konfigurasi Pengaturan
Mode perekaman operasi Berkelanjutan
Konfigurasi catu 3 fase Y, 4 kabel (L1, L2, L3, PE)
Tegangan listrik (± 10%), arus jangka panjang, arus puncak, fre-kuensi
3 380 V, 80 A, 338 Apk, 50/60 Hz3 400 V, 76 A, 330 Apk, 50/60 Hz3 415 V, 73 A, 325 Apk, 50/60 Hz3 440 V, 69 A, 315 Apk, 50/60 Hz3 480 V, 63 A, 300 Apk, 50/60 Hz
Daya sementara MAKS. 100 kVA
Resistansi maksimal di terminal input listrik pada sistemUntuk nomor katalog saat ini: 722221, 722222, 722223, 722224,722225, 722226, 722227, dan 722228
380 V: 74 mOhm400 V: 140 mOhm415 V: 215 mOhm440 V: 325 mOhm480 V: 465 mOhm
Resistansi maksimal di terminal input listrik pada sistemUntuk nomor katalog sebelumnya: 722063, 722064, 722067,722068, 722078, dan 722079
400 V: 140 mOhm415 V: 215 mOhm440 V: 325 mOhm480 V: 465 mOhm
CATATAN Semua kabel fase tersambung memiliki tombol pemutusan sambungan upstream (80 Ahingga 125 A) sekering atau breaker arus berlebih dengan rating 80 A hingga 125 Adengan karakteristik gG (slow blow).
CATATAN Semua pemasangan dan pengkabelan sampai daya listrik masuk akan dipasang dandiverifikasi sesuai peraturan setempat yang berlaku.
Informasi Teknis Kolimator
Azurion Rilis 2.1 Petunjuk Penggunaan 328 Philips 4522 203 78624