KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950 Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203
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 20501910338
Nama Dagang / Merek : PHILIPS Efficia CMS200 Central Monitoring System Kelompok / Kelas Resiko : Elektromedik Non Radiasi / C
Kategori Produk : Peralatan Kardiologi
Sub Kategori : Peralatan Kardiologi Diagnostik
Jenis Produk : Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Tipe / Ukuran : 863352
Kemasan : Unit
Nama Produsen / Pabrikan : PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC., P.R., China Untuk PHILIPS MEDICAL SYSTEMS., United States
Nama Pendaftar : PT. PHILIPS INDONESIA COMMERCIAL, DKI Jakarta Atas dasar lisensi dari : -
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 10 Januari 2022.
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 kategori, sub kategori, dan jenis produk dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21501712406 tanggal 8 Mei 2017. 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, 21 Februari 2019
PHILIPS Efficia CMS200
Diproduksi oleh:
Philips Goldway (Shenzhen) Industrial Inc.
No.2 Keji North 3
rdRoad, Nanshan District, 518057 Shenzhen, P.R. China
Untuk
Philips Medical Systems
3000 Minuteman Road, Andover, MA 01810 USA Diimpor dan didistribusikan oleh:
PT. Philips Indonesia Commercial
Jl. Buncit Raya Kav. 99-100
Jakarta 12510, Indonesia
KEMENKES RI AKL
When you need a cost-eff ective, fl exible option for comprehensive central monitoring, Philips Effi cia CMS200 works with your SureSigns VM4, VM6 and VM8, as well as Effi cia CM10, CM12, CM100, CM120 and CM150 patient monitors to provide a centralized hub of vital monitoring information. Apart from monitoring, it also provides data storage, and secondary alarming capabilities that include audible and visual notifi cation of alarm conditions reported by the patient monitors in its network.
Key advantages
• Single- or dual-screen display with fl exible sector layout to meet a variety of clinical needs and workfl ows
• To reduce your eff ort and the potential for errors, patient admissions, alarming, and NBP settings - including remote NBP start/stop - are synchronized with supported bedside monitors
• Comprehensive access to data for review, including full disclosure waveform trending for all parameters
• HL7 data export to EMR, to simplify compiling your records
• Intuitive user interface, help window, and online tutorials for ease of use
Efficia
CMS200 central monitoring system
Cost-eff ective
central monitoring
Diproduksi oleh:
Philips Goldway (Shenzhen) Industrial Inc.
No.2 Keji North 3rd Road, Nanshan District, 518057 Shenzhen, P.R. China
Untuk
Philips Medical Systems
3000 Minuteman Road, Andover, MA 01810 USA
Diimpor dan didistribusikan oleh:
PT. Philips Indonesia Commercial
Jl. Buncit Raya Kav. 99-100
Jakarta 12510, Indonesia
KEMENKES RI AKL
Measurements
The following measurements are displayed at the Efficia Central if available from the bedside monitor1: heart rate, arrhythmia, 10-lead ECG, ST, respiratory rate, pulse rate, temperature, non-invasive blood pressure, up to 2 channels of invasive blood pressure, SpO2, and CO2, Masimo® SET®, Masimo rainbow® SET, and Cardiac Output
Waveforms
The following waveforms are displayed at the Efficia Central if available from the bedside monitors: ECG (I, II, III, aVR, aVL, aVF, V1–V6), respiration, invasive blood pressure, SpO2, and CO2
Bed layout
• Simultaneously view up to 16 beds on a single display or 32 beds on a dual display
• Maximum 32 beds and maximum 8 pages per system
• User-configurable layout on each page
Alarms
• Three alarm priorities: high, medium, and low
• Audible and visual alarms
• Alarm history for each patient, including alarm message, alarm time, alarm priority, and associated ECG waveform
• Synchronized alarm settings between the Efficia Central and bedside monitors
• Alarm silencing synchronized with bedside monitor
Printed reports (printer is optional)
• Real time numeric data and waveforms
• Tabular trend data
• Graphical trend data
• NBP trend data
• Alarm/event history
• Retrospective ECG waveforms
• Full disclousure waveforms
• Patient window
Data storage and review
• Ten days of graphical and tabular trend data
• Ten days of full-disclosure waveforms, including ECG
• Ten days of NBP measurements with all associated parameters
• Ten days of alarm history
• Stored data can be retrieved for up to 30 days after discharge
License key specifications
• Input power: USB 2.0, 5.0V
• Back-up power: two alkaline batteries
• License key enables configuration options and also issues an alarm if a system failure occurs
Ethernet LAN communication
• Network protocol: IEEE 802.3u
• Transmission rate: *10mbps
• Network cable: CAT5 UTP
• HL7 export via Ethernet port
Standards
• Software meets the following medical device standards:
- EN/IEC 62304:2006 - EN/IEC 62366:2007
Supported monitors
Supported SureSigns monitors include VM4, VM6, and VM8 patient monitors running software version A.03.9x and later.
Supported Efficia monitors include CM10, CM12, CM100, CM120 and CM150 patient monitors
System components
• Philips Efficia Central software (S863352)
• PC host
• Network switch
• License key
• LCD display (and optional second display, if ordered)
• External speaker bar
• Keyboard and mouse
• Optional printer, if ordered
Options
B08 8-bed option B16 16-bed option B32 32-bed option D01 Single display option*
D02 Dual display option*
P01 Laser printer
N01 2nd NIC (network interface card)
* D01 is standard with the 8-bed option. D02 is standard with 32-bed option. For 16-bed option, choose D01 or D02
Easily configured and flexible page and sector layout meet the needs of your clinical unit and each patient
Big numbers let clinicians view numeric data from a distance
The patient window displays further waveforms and patient measurement results, helping you get a comprehensive understanding of a patient’s condition
© 2015 Koninklijke Philips N.V. All rights reserved.
Specifi cations are subject to change without notice.
Trademarks are the property of Koninklijke Philips N.V.
(Royal Philips) or their respective owners.
Masimo, rainbow, and SET are registered trademarks of Masimo Corporation.
1 Not all features are available in all countries. Please check with your Philips representative.
www.philips.com/Effi cia [email protected]
Printed in The Netherlands 4522 991 11961 * Jul 2015
Network diagram
Philips Effi cia Central PC, network switch, and dual display
Up to 32 bedside monitors
