Spek+NIE+brosur 3D Package
Spek+NIE+brosur 3D Package
CFV-E30SK
- Suhu dalam keadaan beroperasi 0-40C
- Kelembaban 30% -85%
- Suhu penyimpanan -20 s/d 60 C
-Tekanan penyimpanan 700hPa-1000hPa
- Dimensi 160x45mm
- Berat 16g
LMD-X310MT
-Panel a-Si TFT Active Matrix LCD
- Picture Size (Diagonal) 789.06 mm (31 1/8 inches)
-Effective Picture Size (H x V) 698.0 x 368.1 mm
(27 1/2 x 14 1/2 inches)
-Pixel pitch 0.1704 x 0.1704 mm
-Resolution (H x V) 4096 x 2160 pixels
-Aspect 17:9
-Pixel Efficiency > 0.9999
-Backlight LED
-Panel Technology LCD with IPS
-Luminance (Panel Specification) 435 cd/m2 (Typical)
-Contrast Ratio 1450 : 1
-Number of Gray scale 10 bit
-Colors 1073741824
-Panel Frame Rate 50/60 Hz
-Viewing Angle (Panel Specification) > 89°/ > 89°/ > 89°/ > 89°
-Vertical Viewing Angle (3D Mode) 27° at a viewing distance more
than 775 mm, c
-Gamma 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, Highlight
-HDMI Input HDMI (x1) (HDCP 1.4 correspondence)
-DVI-D Input DVI-D (x1) (HDCP 1.4 correspondence, TMDS single
link)
-SDI Input BNC (x5) (3G/HD/SD-SDI)
24 OLYMPUS OLYMPUS Olympus Unit Peralatan Peralatan Endoscopes 48150.0 31-Mar-21 Olympus set Olympus Shirakawa ISO 13485; AKL CE - EN IEC 60601- 1 unit Indonesia Sumber Daya listrik: Pusat Sistem Video VISERA - OLYMPUS OTV-S200 Olympus -
2D Package set 3 Gastroente Gastroente and 0.089 3 Medical Olympus CE Certificate 20801912064 0197 1 Safety Olympus - Nilai tegangan: 100-240 V AC; dalam ± 10%; ELITE II OTV-S200 adalah Visera Elite II Video System
rologi- rologi- accessories; Systems Co., Ltd., 0197 Electromagneti 2D - Frekuensi terukur: 50/60 Hz; dalam ± 1 Hz; pusat sistem video yang Center OLYMPUS OTV-S200 (1
Urologi; Urologi non-alat Corp., Japan (Directive c Package - Input terukur: 400 VA; dimaksudkan untuk unit)
non-alat Diagnostik; kesehatan Japan 93/42/EEC) - EN ISO 14971 digunakan dengan kepala - LMD-X2705MD 3D LCD Color
kesehatan non-alat Risks Ukuran: kamera OLYMPUS, Monitor (1 unit)
kesehatan management - Dimensi (maksimum): 383 (W) x 199 (H) x 506 (D) mm; endoskopi, monitor, - WM-NP-1-LKL Trolley
- Berat: 19,3 kg aksesori EndoTherapy, dan Laparoscopy (1 unit)
peralatan pendukung - ENDO Imaging Record (1 unit)
- Output sinyal digital: HD-SDI (SMPTE292M), DVI (WUXGA, 1080 lainnya untuk diagnosis,
piksel, atau SXGA dapat dipilih) perawatan, dan observasi
- Zoom elektronik: Tingkat pembesaran gambar dapat dipilih. 3 video endoskopi.
mode (1.0x, 1.2x, 1.5x)
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
Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :
ALAT KESEHATAN
Kemasan : Unit
Nama Produsen / Pabrikan : SHIRAKAWA OLYMPUS CO., LTD, Japan
Untuk OLYMPUS MEDICAL SYSTEMS CORP, Japan
Melalui OLYMPUS SINGAPORE PTE., LTD, Singapore
Nama Pendaftar : PT. MURSMEDIC, DKI Jakarta
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 01 April 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 perpanjangan dari Nomor Izin Edar Alat Kesehatan
KEMENKES RI AKL 20801912156 tanggal 11 April 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.
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203
LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 20801912156
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
3D Eye shield with Shield frame
* These products can not be used for eye-protection against physical shock,
harmful rays and other hazards in different fields.
CFV-E30SK
3D Eye Shield Kit Shield Frame (1 piece) Starter kit for surgeons and medical staff
Disposable 3D Eye Shield (3 pieces) to view 3D images on 3D monitors
CFV-E20SK
2D Eye Shield Kit Starter kit for clinical staff supporting
Shield Frame (1 piece)
the surgeon in the operating room,
Disposable 2D Eye Shield (3 pieces)
with 2D images
CFV-E30D
3D Eye Shield Pack Disposable 3D Eye Shield
Optional replacement 3D eye shields
(15 pieces)
(15 pieces)
CFV-E20D
2D Eye Shield Pack Disposable 2D Eye Shield
Optional replacement 2D eye shields
(15 pieces)
(15 pieces)
CFV-B100
Shield Frame
Shield Frame (1 piece) Optional replacement shield frame
CFV-E30SK 3D Eye Shield Kit
The CFV-E30SK is a 3D eye shield kit that includes one frame (CFV-B100) and three
disposable 3D eye shields. The frame and each eye shield provide eye protection to
health professionals in the operating room as they view 3D images on Sony’s 3D
Medical Monitors.
Each 3D circular polarizing eye shield
fits into the shield frame, which is light
and comfortable to wear for extended
periods of time. Wearing the eye shield
and frame, healthcare professionals
are protected from blood splashes
and other bodily fluids in the operating
room during clinical procedures.
The CFV-E20SK is a 2D eye shield kit that includes one frame (CFV-B100) and three
disposable 2D eye shields designed for use by clinical staff who support the surgeon.
As these people typically work under 2D conditions, they are liable to suffer from
so-called ‘3D sickness’ if they use 3D
eye shields. To avoid this discomfort
and ensure operational efficiency,
they require the 2D filter provided by
2D eye shields. This filter allows them
to view the same 3D monitor images
in 2D.
CFV-B100/E30D/E20D
For ongoing use of the CFV-E30SK and CFV-E20SK solutions, the following products are available:
• The CFV-B100 is an optional lightweight replacement shield frame for the CFV-E30SK/E20SK
• The CFV-E30D provides 15 additional disposable 3D eye shields for the CFV-E30SK
• The CFV-E20D provides 15 additional disposable 2D eye shields for the CFV-E20SK
Operating Temperature 0 °C to 40 °C 0 °C to 40 °C 0 °C to 40 °C 0 °C to 40 °C 0 °C to 40 °C
Operating Humidity 30% to 85% 30% to 85% 30% to 85% 30% to 85% 30% to 85%
Storage/Transport –20 °C to +60 °C –20 °C to +60 °C –20 °C to +60 °C –20 °C to +60 °C –20 °C to +60 °C
Temperature
Storage/Transport 20% to 90% 20% to 90% 20% to 90% 20% to 90% 20% to 90%
Humidity
Operating/Storage/ 700 hPa to 1060 hPa 700 hPa to 1060 hPa 700 hPa to 1060 hPa 700 hPa to 1060 hPa 700 hPa to 1060 hPa
Transport Pressure
Dimensions* Approx. 160 x 45 mm Approx. 160 x 45 mm Approx. 235 x 77 mm Approx. 235 x 77 mm Approx. 160 x 45 mm
(Shield Frame) (1) (Shield Frame) (1) (3D Eye Shield) (15) (2D Eye Shield) (15)
Approx. 235 x 77 mm Approx. 235 x 77 mm
(3D Eye Shield) (3) (2D Eye Shield) (3)
6 3/8 × 1 13/16 inches 6 3/8 × 1 13/16 inches 9 3/8 × 3 1/8 inches 9 3/8 × 3 1/8 inches 6 3/8 × 1 13/16 inches
(Shield Frame) (1) (Shield Frame) (1) (3D Eye Shield) (15) (2D Eye Shield) (15)
9 3/8 × 3 1/8 inches 9 3/8 × 3 1/8 inches
(3D Eye Shield) (3) (2D Eye Shield) (3)
Approx. 0.56 oz Approx. 0.56 oz Approx. 0.25 oz Approx. 0.25 oz Approx. 0.56 oz
(Shield Frame) (1) (Shield Frame) (1) (3D Eye Shield) (15) (2D Eye Shield) (15)
Approx. 0.25 oz Approx. 0.25 oz
(3D Eye Shield) (3) (2D Eye Shield) (3)
Supplied Accessories Operating Instructions (1) Operating Instructions (1) Operating Instructions (1) Operating Instructions (1) Operating Instructions (1)
Attachment Procedure (1) Attachment Procedure (1) Attachment Procedure (1) Attachment Procedure (1) Attachment Procedure (1)
Related Products
Note: The BKM-30GM/31GM has the same polarization characteristics as the CFV-E30SK/E20SK.
MK20040V1OHB15SEP
LMD-X550MT
LMD-X310MT
LMD-X550MT
LMD-X310MT
LCD MONITOR
4K and 3D imaging is becoming increasingly popular in
today’s operating rooms. High-resolution 4K imaging
and 3D imaging offer depth perception and spatial
orientation, providing medical staff with a more
realistic visualization of complex surgical
procedures.
LR
Side-by-side Line-by-line
L
R
Top & bottom
L
Dual stream*
R
comprises one frame and three disposable
3D eye-shields, and is designed for user
comfort over extended periods.
*SDI Only
LMD-X310MT
LMD-X550MT
Power indicator
CONTROL button
OSD menu operation buttons
2D/3D select button HDMI cable holder 5 V 1.6 A output connector
CUSTOM button HDMI input connector DVI-D input/output connector
A.I.M.E. button 3G/HD/SD-SDI input/output connector (BNC type) SDI 1 (4K/HD) SERIAL REMOTE RS-232C connector (D-sub 9-pin, female)
2 or 3 screen display setting buttons 3G/HD/SD-SDI input/output connector (BNC type) SDI 2 (HD) (DC 26 V input) connector (LMD-X310MT only)
Input select buttons SERIAL REMOTE connector (RJ-45) (equipotential) terminal
(ON/STANDBY) switch 12 V 1.7 A output connector (AC input) connector (LMD-X550MT only)
Specifications Dimensions
LMD-X310MT LMD-X550MT LMD-X310MT
Picture Performance Front 753.8 (29 3/4)
Panel a-Si TFT Active Matrix LCD
Picture Size (Diagonal) 789.06 mm (31 1/8 inches) 1387.8 mm (54 3/4 inches)
Effective Picture Size (H x V) 698.0 x 368.1 mm 1209.6 x 680.4 mm
(27 1/2 x 14 1/2 inches) (47 5/8 x 26 7/8 inches)
456.4 (18)
Pixel pitch 0.1704 x 0.1704 mm 0.315 x 0.315 mm
244.7 (9 3/4)
Resolution (H x V) 4096 x 2160 pixels 3840 x 2160 pixels
Aspect 17:9 16:9
Pixel Efficiency > 0.9999
Backlight LED
200 (7 7/8)
Panel Technology LCD with IPS Rear M6 Side 69.3 (2 3/4)
100 (4) 28 (1 1/8)
Luminance (Panel Specification) 435 cd/m (Typical)2
520 cd/m (typical)
2
DVI-D Input DVI-D (x1) (HDCP 1.4 correspondence, TMDS single link)
SDI Input BNC (x5) (3G/HD/SD-SDI)
(29 3/4)
(10 5/8)
219.2
AC adaptor (AC-300MD): 3.2 A to 1.3 A
269.2
(29 3/4)
(7 7/8)
300
50/60 Hz, 2.1 A to 1.0 A
200
Power Consumption LCD Monitor: Approx. 180 W (max.) Approx. 290 W (max.)
Operating Temperature 0 °C to 40 °C (32 °F to 104 °F) (Recommended: 20 °C to 30 °C (68 °F to 86 °F))
Operating Humidity 30% to 85% (no condensation)
Storage/Transport Temperature -20 °C to +60 °C (-4 °F to +140 °F) Unit: mm (inches)
Storage/Transport Humidity 0% to 90%
Operating/Storage/ 700 hPa to 1060 hPa
Transport Pressure Optional Accessories
Dimensions (W x H x D)* 753.8 x 456.4 x 69.3 mm 1264.6 x 771.5 x 85.5 mm
(29 3/4x 18 x 2 3/4 inches) (49 7/8 x 30 3/8 x 3 3/8 inches)
(Slimmest D 28 mm) (Slimmest D 33.9 mm)
Mass Approx. 11.8 kg (26 lb 0.23 oz) Approx. 35.2 kg (77 lb 9.6 oz)
Mounting 100 x 100 mm VESA 200 x 200 mm VESA
100 x 200 mm VESA 300 x 300 mm VESA
Supplied Accessories
CFV-E30SK CFV-E20SK CFV-E30D CFV-E20D
3D Eye Shield Kit (CFV-E30SK) (1) 3D Eye Shield Kit (CFV-E30SK) (1) 3D Eye Shield Kit 2D Eye Shield Kit 3D Eye Shield 2D Eye Shield
• Frame (1) • Frame (1)
• 3D shield (3) • 3D shield (3)
AC adaptor (AC-300MD) (1) AC power plug holder (2)
AC power plug holder (2) Before Using This Unit (1)
Before Using This Unit (1) Instructions for Use of the 3D Eye Shield Kit (1)
Instructions for Use of the AC Adaptor (1) CD-ROM (including the Instructions for Use) (1)
Instructions for Use of the 3D Eye Shield Kit (1) Screws for the VESA mount, M6×12 mm (4)
CD-ROM (including the Instructions for Use) (1) Service Contact List (1)
Screws for the VESA mount, M4×12 mm (4)
CFV-B100 SU-600MD* NUA-BK10*
Service Contact List (1)
Shield Frame Monitor Stand IP Converter Bracket
* The values for dimensions are approximate. Bracket for IP Converter
(NU-IP40S/NU-IP40D) * Only for LMD-X310MT
This product is distributed to the US and EU as a medical device and satisfies product safety standards
(e.g. IEC 60601-1).**
** For more details, please contact your nearest Sony sales office or an authorized dealer.