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
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 diberikan persetujuan untuk diedarkan dengan :
NOMOR IZIN EDAR A L A T K E S E H A T A N
KEMENKES RI AKL 21501513242
Nama Dagang / Merek : PHILIPS IntelliSpace Cardiovascular Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B
Kategori Produk : Peralatan Radiologi
Sub Kategori : Peralatan Radiologi Diagnostik
Jenis Produk : Picture archiving and communications system.
Tipe / Ukuran : -
Kemasan : 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 14 Februari 2024.
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 penandaan dan alamat pabrik dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21501513242 tanggal 01 Agustus 2019. 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.
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Jakarta, 02 September 2020
IntelliSpaceCardiovascular
Ref:830089
NomorSeri:lihatpenandaanutamaberbahasaInggris
Diproduksioleh:
PhilipsMedicalSystemsNederlandB.V.
Veenpluis6,5684PCBest,TheNetherlands
Diimpordandidistribusikanoleh:
PTPhilipsIndonesiaCommercial
GedungCibisNineLantai10
Jl.TBSimatupangNo.2,Jakarta12560,Indonesia
KEMENKESRIAKL
IntelliSpace Cardiovascular
Image and information management solution
Transform the way you work.
And think.
Cardiovascular
IntelliSpace
EICI.0026152 IntelliSpace Cardiovascular Brochure Authorized Version: 3
Pr inte d copies are not contro ll ed
IntelliSpaceCardiovascular
Ref:830089
NomorSeri:lihatpenandaanutamaberbahasaInggris
Diproduksioleh:
PhilipsMedicalSystemsNederlandB.V.
Veenpluis6,5684PCBest,TheNetherlands
Diimpordandidistribusikanoleh:
PTPhilipsIndonesiaCommercial
GedungCibisNineLantai10
Jl.TBSimatupangNo.2,Jakarta12560,Indonesia
KEMENKESRIAKL
2 2
The cardiovascular information
you need
Your patients’ lives are a continuum with multiple cardiovascular incidents happening throughout their lifetimes. Each and every one of your patients has a history of
symptoms, tests, diagnoses, and treatments that makes that patient different from any other. Shouldn’t the tools you use to care for these unique individuals reflect this?
Cardiovascular care continuum
IntelliSpace Cardiovascular is designed specifically with you in mind to help streamline clinical workflow and improve operational performance across your entire cardiovascular service line.
At the heart of IntelliSpace Cardiovascular is the Workspace, which provides access to relevant cardiovascular images and information anytime, virtually anywhere*.
*It is the user’s responsibility to ensure that Philips network performance requirements̜˳àì®̜à̜ÙܨÍÜÆÇˠ̜oQ?˴̜ for IntelliSpace Cardiovascular are met.
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3 3
All in one place
Exceptional access with the WebAPI
Launching into various products to get a complete view of a patient can be time- consuming and frustrating. With the WebAPI, you can easily access third-party applications – including scheduling systems, lab applications, and third-party specialty PACS – within system, study, patient, and series context.
Connected cardiology begins here
Accessible anytime and virtually anywhere,* your IntelliSpace Cardiovascular Workspace supports informed decision-making by providing a comprehensive overview of your patient. You can personalize the Workspace for fast access to your information, and use it to connect with the Cardiology Timeline, which delivers a graphical, panoramic, chronological overview of your patients’ cardiovascular care continuum to help you enhance the quality of cardiac care. The Cardiology Timeline also serves as a launch pad to detailed clinical records.
IntelliSpace Cardiovascular also has many options for delivering information where it is needed. It interfaces with IntelliBridge Enterprise, for interoperability with your ADT, EMR, and existing specialized clinical information systems. You can use the EMR/HIS interface to launch into IntelliSpace Cardiovascular when working in your Enterprise Applications system, and while maintaining the patient or procedure context. For those times when important information only exists on paper, you also can convert paper copies to PDF files and import them into IntelliSpace Cardiovascular.
CT Cardiac
MR Ultrasound
Advanced visualization
Diagnostic X-ray
Cardiac cath lab
IntelliSpace Cardiovascular ECG
*It is the user’s responsibility to ensure that Philips network performance requirements ˳àì®̜à̜ÙܨÍÜÆÇˠ̜oQ?˴̜for IntelliSpace Cardiovascular are met.
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4 4 4
Diagnostic quality echo images at your fingertips
You can access diagnostic quality images via the web, so you can review patients’ echo images from your office or home. IntelliSpace Cardiovascular uses zero-footprint technology to provide access to the images you need without burdening your IT devices.4
Web-based
echo reporting
Customized report templates
The easy-to-use report template editor allows you to create templates that define how the information in the report will be presented. The report builder uses a “what- you-see-is-what-you-get” methodology so you see the layout of your template being built right before your eyes.
4 4
Anytime, virtually anywhere*
Now you can complete your echo reporting via the web. IntelliSpace Cardiovascular allows you to easily include wall motion scoring and findings in your reports, perform measurements, and even finalize your reports – anytime and virtually anywhere.*
*It is the user’s responsibility to ensure that Philips network performance requirements ˳àì®̜à̜ÙܨÍÜÆÇˠ̜oQ?˴̜for IntelliSpace Cardiovascular are met.
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5 5 5
Focus your workflow
The Workspace becomes yours from the moment you access your tailored work environment with a single log- in. The high level of task-driven customization helps you create an environment that reflects your working style.
Organize your day with the user-centric layer. Simply create a customized worklist to filter the information you need, when you need it. You can also save time by using the graphical study list within the Search and Worklists applets to get a glimpse of images before you enter the patient- centric layer. Then use the icon-based patient-layer to move quickly and easily into the clinical application.
Take a short cut to work
A number of context-sensitive applets, ranging from Search and Worklists applets to Document Viewer and Image Viewer applets, are designed to streamline workflow. They are readily available on your personalized, role-based configuration and the chosen workflow.
Arrange your Workspace
The Workspace also offers an intuitive interface with available advanced controls and streamlined navigation.
This makes it easy to intelligently group results, quickly select and drag items, create robust filters, and rapidly configure your preferred Workspace, so that you see information in the way that matters most to you.
Analyze, assess, and manage your patients’ vital cardiovascular information from a single Workspace Access previous studies, helping to avoid unnecessary retests Provide clinicians with access to comprehensive cardiovascular data for consultation and analysis Access advanced clinical tools to perform comprehensive analysis and reporting, allowing for fast and informed cardiac care treatment decisions Foster collaboration across your cardiovascular service line – both within your hospital and among your referrers and other healthcare providers
5 5
With IntelliSpace
Cardiovascular, you can:
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6
See the big picture
Given the complex labyrinth of information systems in the typical healthcare enterprise, we know that every system needs to prove its worth.
IntelliSpace Cardiovascular, with access to advanced clinical applications, brings multi-modality images and clinical tools together in a single workspace. From the same place you view images, you can access the clinical depth of advanced applications that are optimized for ease of use.
All in a user-defined environment that supports clinical decision-making, streamlines clinical workflow, and enhances operational performance and patient care.
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With IntelliSpace
Cardiovascular, you can:
• Configure a single-modality, departmental solution that can grow into a comprehensive multi-modality, enterprise-wide cardiovascular image and information management solution
• Protect your investment with a solution that is interoperable with medical equipment and information systems from a variety of vendors
• Control implementation and maintenance costs through zero-footprint installation
• Improve information exchange across your clinical ecosystem
7 Examine data across your patient
population for trending purposes.
Quickly identify trends to support improvement of hospital workflows.
Uncover opportunities for enhancing procedural efficiency.
Enhance operational efficiency
Advanced Analytics data mining tool helps you verify that you are operating efficiently. It uses a single, industry-standard, reporting services tool to access data stored within IntelliSpace Cardiovascular.
Detailed operational information
In addition to providing clinicians with the tools needed to enhance care, IntelliSpace Cardiovascular offers access to a wealth of detailed information to help streamline your operations, such as supply utilization and productivity and outcomes reporting. It also interfaces to other clinical systems and devices within the cardiology department, as well as to HIS and EMR systems that span your enterprise.
Diagnostic Guidance aids in reporting standards With the IntelliSpace Cardiovascular Diagnostic Guidance application, you can create rules that define relationships among distinct finding codes, measurements, and other data points.The application operates during echocardiography reporting and warns you of conflicts, inconsistencies, omissions, or patterns that could otherwise go unreported or be misreported, and provides you the ability to review the data before report finalization.
You can launch the Advanced Analytics tool directly from Internet Explorer®to gain fast access to the data you need.
Intelligently designed database views guide you through the tables and data you need.
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Our next-generation cardiovascular image and information management solution provides a single point of access anytime, virtually anywhere* to a patient-centric repository of comprehensive cardiovascular information that helps to support clinical decision- making, streamline workflow, and reduce costs.
• Enhance workflow efficiency through Workspace customization, the ability to interact with multiple applets at the same time, and our unique Cardiology Timeline, helping to save time and resources
• Deploy a rich clinical solution within your existing infrastructure
With IntelliSpace Cardiovascular, you can:
• Streamline implementation with low maintenance requirements and a zero-footprint environment
• Provide clinicians with easy access to prior cardiovascular exams to help reduce unnecessary and costly retesting
8
When and where
you need it
Industry-standard data exchange
The IntelliBridge Enterprise interoperability solution supports industry-standard interfacing technologies and protocols including HL7, DICOM, TCP/IP, and more. So you can count on a two-way exchange of information between the IntelliSpace Cardiovascular portfolio and a wide range of external systems.
*It is the user’s responsibility to ensure that Philips network performance requirements̜˳àì®̜à̜ÙܨÍÜÆÇˠ̜oQ?˴̜ for IntelliSpace Cardiovascular are met.
Pr inte d cop ies are not contro ll ed
Clinical Operational Financial
CT Cardiac
MR Ultrasound
Advanced visualization
Diagnostic X-ray
Cardiac cath lab
IntelliSpace Cardiovascular ECG
With IntelliSpace Cardiovascular, you can quickly obtain, analyze, and share rich, consolidated data from a wide variety of departmental systems and applications.
9
IntelliSpace Cardiovascular
benefits your enterprise
• Clinically, through quick and easy access to images and information
• Operationally, through the ability to access a variety of systems and applications from a single location, and analyze data to streamline efficiency
• Financially, through zero-footprint technology and interoperability you can decrease deployment costs and save time while interfacing to your existing systems
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Discover
the Philips difference
IntelliSpace Cardiovascular is designed to help you and your organization enhance workflow within specialty cardiology departments and across your entire cardiovascular service line. While advanced technology is critical to achieving this goal, so is Philips passion for cardiovascular excellence and our commitment to helping you meet your clinical and administrative challenges.
10
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Unleashing the power of information sharing
We at Philips Healthcare focus on empowering caregivers across the enterprise to make fast, informed clinical decisions wherever care is delivered, through:
Intelligent clinical workflows
Leveraging images and information from disparate clinical systems to create rich clinical summaries and contextual presentations at the point of care
Personalized care
Customizable clinical solutions to elevate the user experience, and tailor clinical guidance, based on best practices and evidence
Longitudinal patient care
Graphical overview of patient studies over time to orchestrate and facilitate collaboration across specialty care teams
11
We invite you to draw on our knowledge and experience to help build a cardiovascular
information solution designed to make a difference.
For more than 40 years, we’ve been developing our in-depth knowledge of clinical workflow across the cardiovascular service line – through collaboration with leading healthcare institutions, empirical research, and strategic business acquisitions. Along the way, Philips professionals have amassed considerable expertise in the fields of cardiovascular imaging, clinical decision support, departmental workflow, and information systems.
With thousands of clinical information systems deployed worldwide, we’ve built a reputation as a global leader in cardiology.
Philips offers an extensive range of services to help implement, integrate, and configure the IntelliSpace Cardiovascular solution, including project management, application training, report customization, and workflow consulting.
11
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©2016 Koninklijke Philips N.V. All rights are reserved. Philips reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Trademarks are the property of Koninklijke Philips N.V. or their respective owners.
www.philips.com/IntelliSpaceCardiovascular
Printed in The Netherlands.
4522 991 20131 * JUNE 2016
Pr inte d cop ies are not contro ll ed
This is a representation of an electronic record that was signed electronically in our Regulated System.
This page is the manifestation of the electronic signatures used in compliance with the organizations electronic signature policies and procedures.
UserName: Marcel Alberti (310099603) Title: Department Manager
Date: Thursday, 07 May 2020, 01:23 PM W. Europe Standard Time Meaning: This document has changed to Authorized status
================================================
Pr inte d cop ies are not contro ll ed
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
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 diberikan persetujuan untuk diedarkan dengan :
NOMOR IZIN EDAR A L A T K E S E H A T A N
KEMENKES RI AKL 21501512832
Nama Dagang / Merek : PHILIPS Xper Information Management System Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B
Kategori Produk : Peralatan Radiologi
Sub Kategori : Peralatan Radiologi Diagnostik
Jenis Produk : Picture archiving and communications system.
Tipe / Ukuran : versi 5.1
Kemasan : 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 11 Januari 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 perubahan tipe produk dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21501512832 tanggal 10 Oktober 2018. 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.
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Jakarta, 01 Juli 2020
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Connected
cardiology across your enterprise
with the interventional module of IntelliSpace Cardiovascular
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workflow with Philips Xper Information Management
Xper IM is one of the world’s leading cath lab information management systems. It helps you create more efficient workflows with physiomonitoring and cath lab data management, facilitating collaboration across the cardiovascular teams with less effort on your part.
Xper IM, as the interventional module of IntelliSpace Cardiovascular platform, takes connected cardiology further, together.
Cath labs are growing in
complexity, but
your workflow
should not
with IntelliSpace Cardiovascular
Azurion/
Allura Xper Flex
Cardio Xper IM
Interventional cath lab
IntelliSpace Cardiovascular
CT
Ca rdia
c M
R
Interventional cardiology visua
lization Ad
van ced
Ult
rasound
ECG
X-ray Diagnostic
Connected
Cath lab data management is becoming more complex, and caregivers need workflows which can connect this information in a convenient way. Through Xper IM, multiple clinical, operational and financial information systems within the hospital are linked to create more efficient workflows, with less effort for the clinician.
Secure
Data security is a high priority for hospitals as their systems transform digitally and hold more and more sensitive patient information. The adoption of secure, industry-standard data exchange technologies enables two-way exchanges of information with external information systems. This helps provide data security and patient privacy.
Intelligent
The faster you can make intelligent and informed clinical decisions, the faster that care can be delivered to those who need it most. Our decision support tools drive provider reimbursement and create positive clinical, operational and financial outcomes.
caregivers
across the enterprise to make fast, informed clinical decisions
wherever care
is delivered
when and where you need it
Our range of interfaces brings together disparate data across the patient care continuum to empower action in the clinical setting. With these tools, you have convenient access to the information you need, and can devote more time to improving patient outcomes.
ADT & Orders
Results
Inventory*
Billing Epic Cupid
Real-time labs Discreet
clinical data DICOM worklist
& MPPS
IntelliVue PIC iX
Across the enterprise
Xper IM
Integrated workflows across multiple care settings
Pre-procedure Interventional procedure Post-procedure Interoperability
IntelliBridge Enterprise
• Enables two-way exchange of information between the cardiology informatics portfolio and a wide range of external systems
• Interfaces with your EMR, and existing specialized clinical information systems
A single engine for enterprise interoperability
• Supports industry-standard interfacing technologies and protocols including HL7, DICOM, TCP/IP, and more
• Reduces the integration workload for your IT department, bringing multiple interfacing solutions under one provider
* Outbound inventory in IntelliBridge Enterprise 07 for Xper IM
Healthcare organizations are seeing a proliferation of targeted cyber-attacks, ransomware threats and data breaches. In fact, healthcare is one of cybercrime's most targeted sectors, ahead of manufacturing and financial services
1.
Assurance that your patients’ data is safe To counter these increasingly sophisticated attacks on hospital IT systems, Philips continually invests in software security compliance. Our focus areas include:
• Supporting the latest operating systems, mitigating data security risks posed by older non-supported versions
• Implementing security controls in the end to end software development and deployment life-cycle
• Ensuring that the latest Windows security updates are validated with the system, and communicated as such to enable quick patching against malware
• Ongoing vigilance to adopt applicable security industry best practices
1 IBM X-Force® Research - 2016 Cyber Security Intelligence Index
2 Health Insurance Portability and Accountability Act of 1996
An attack can damage a hospital's reputation and bring financial penalties, but it is becoming increasingly clear that such a threat also impacts patient safety and quality of care. Consequently, hospitals are demanding tighter security features from vendors and insisting they follow best practices, adopting industry standard security frameworks in addition to HIPAA privacy rules2.
support your workflow
Having the right technological capabilities allows caregivers to make fast, informed clinical decisions when it matters most.
Xper IM is designed to orchestrate efficient workflows, facilitating collaboration across cardiovascular teams to create rich panoramic patient impressions, and driving provider reimbursement with positive clinical and economic outcomes.
Coordinated physiomonitoring across the care continuum to interface with IntelliVue PIC iX.
Automated data collection and customized charting workflows, for example, for near real-time lab results and updates.
Scalable interoperability and integrated inventory for cost reduction and management.
Auto-populated physician transcription to interface with Nuance PowerScribe.
Billing and coding aligned to coding standards (ICD-10 and CPT) and crosstalk for ease of use and better accuracy.
Intelligent cardiovascular data management with analytics capabilities.
Integration with
IntelliSpace
Cardiovascular
for a flexible and
modular solution
that can grow as
you grow.
Together with Azurion/Allura systems, dedicated cardiology applications and Volcano devices, Xper IM and IntelliSpace Cardiovascular form a broad and ever-evolving Philips cath lab solution.
Dedicated cardiology applications
CT TrueView CardiacSwing
/ 3DCA Ultrasound
EPIQ (TEE)
EchoNavigator HeartNavigator
System platform configuration and workflow options
FlexVision Pro Azurion /
AlluraClarity / Allura Xper
TSM Pro FlexSpot 2D-QA DoseAware
Dynamic Coronary Roadmap
iFR Roadmap StentBoost Live
Philips
Volcano devices and applications
SyncVision iFR Co-registration
SyncVision IVUS Co-registration
Eagle Eye® IVUS Catheter Verrata Pressure®
Guide Wire
Integrated tools
IntelliSpace Cardiovascular
Ultrasound CX50
DoseWise Portal Xper IM /
XperFlex Cardio Integrated
CORE
EP Navigator
complement our Xper Information Management offering
care of your Xper IM solution, you can worry about what really matters – delivering better care, to more people, at lower cost.
The Philips difference*
• Regular software upgrades and education services (onsite and remote)
• Obsolescence protection
• Uptime guarantees for a stable and secure system
• Lifecycle support
• Value-added services, such as clinical workflow consulting
*Check with local representative for detailed offering and investment
Support for clinical users:
• Access to data when and where it is needed
• Latest clinical tools
• Support for workflow optimization
• Real-time online education for optimal user experience and use of systems
Support for IT managers:
• Reliable remote diagnosis and fast resolution, as well as incident and problem management
• Assurance of improved system uptime
• Access to the latest clinical and technological features
• Compliance with latest healthcare IT standards
Support for hospital management:
• Transparent total cost of ownership
• High-quality data analytics and performance services
• Support for workflow optimization
• Regular updates help maintain system performance
4522 991 26491 * JUL 2017
