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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




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



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




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

Powered by TCPDF (www.tcpdf.org)

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


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


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



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


How to reach usPlease visit www.philips.com/[email protected]

© 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 5 M12 722227 - MRC 200+ 0508 ROT-GS1003

Azurion 5 M20 722228 - 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


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


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


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


Paparan: 125 kV



Kemampuan pemuatan kontinu (di 23°C) 4000 W(MRC 200: 3200 W)




panas anode 6,4 MHUeff dan maksimal 30 dan 65 kW beban waktu singkat

– MRC 200: Kapasitas penyimpanan panas anode 2,4 MHU




• Kontrol rotor

• Kabel Tegangan Tinggi

• Bagian penutup


Item Spesifikasi


Paparan: 125 kV



Kemampuan pemuatan kontinu (di 23°C) 4000 W






panas anode 6,4 MHUeff dan maksimal 30 dan 65 kW beban waktu singkat




• 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)



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


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


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


1000 mA, 100 kV

§ 201.7.9.2.1.101 d Daya output konstan tertinggi di 100kV, 0,1s


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


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



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.



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).



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
