Kementerian Kesehatan Republik Indonesia: Direktorat Jenderal Kefarmasian Dan Alat Kesehatan

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 :
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 21501312398
Nama Dagang / Merek : ZONCARE Digital Color Doppler Ultrasonic Diagnostic System
Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B
Kategori Produk : Peralatan Radiologi
Sub Kategori : Peralatan Radiologi Diagnostik
Jenis Produk : Ultrasonic pulsed doppler imaging system.
Tipe / Ukuran : ZONCARE-Q9
Kemasan : Unit
Nama Produsen / Pabrikan : WUHAN ZONCARE ELECTRONICS CO., LTD., China
Untuk WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD.,
China
Nama Pendaftar : PT. PERMANA PUTRA MANDIRI, DKI Jakarta
Atas dasar lisensi dari : -
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 23 April 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 perpanjangan dari Nomor Izin Edar KEMENKES RI AKL
21501312398 tanggal 12 Agustus 2016. 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, 09 September 2019
Catatan:
- UU ITE No 11 Tahun 2008 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 21501312398
No. Deskripsi Tipe / Kode

1 Standard 3.5MHz Convex Probe
2 Standard 4D Probe
3 Standard Quality Certificate
4 Standard Users Manual
5 Standard Service Guarantee
6 Standard Declaration of Conformity
7 Optional Packing List
8 Optional 6.5MHz Convex
Transvagianal Porbe
9 Optional 7.5MHz Linier Probe
10 Optional + Type Screw Driver
11 Optional CD and Date Cable
12 Optional USG Printer (BW)
13 Optional USG Printer (Colour)
14 Optional Paper USG Printer
15 Optional 3.5MHz Convex Probe
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini
Jakarta, 09 September 2019
Catatan:
- UU ITE No 11 Tahun 2008 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.
ZONCARE-Q9
High End Full Digital Color Doppler Ultrasound Diagnostic System
System Overview Hard Disc: ≥ 320GB

Application Footswitch: BNC/USB
Abdomen Ethernet Port: 1 (10Mb/1000Mb)
Cardiac External Display: DVI, VGA
Obstetrics External VCR
Gynecology Digital Video Monitor
Urology Compound Video Output Export Image Format:
Small Parts USB Modem PNG, JPEG, BMP, GIF, DICOM
Vascular USB Printer Cine Frame Capacity:
Pediatrics Peripherals/Storage Tray > 8000 frames
Digital B/W Thermal Printer Stored Image Capacity:
Electrical Power DVD/CD Recorder > 50000 images
Voltage: 100V~240V CD-R Storage
Current: 7.0A/4.0A Cine/Image Memory DVD Storage
Frequency: 50/60Hz Cine Memory: 128Mb
Cine Review Speed: 1/8, 1/4, 1/2, 1, 2 Technology
Transducer/Gel Holders Cine Review Loop TP-view Tech
Transducer/Gel Holders: 6 Cine Capture Function Panoramic Imaging Tech
Transducer Hooks: 2 Dual/Quad Image Cine Display Speckle Reduction Tech
Gel Heater: 1 Measurements, Calculations, Annotations- Dual & Triplex Synchronous Display
Physical Specifications on Cine Playback (still image) Directional Power Doppler
Equipment: Elastography Tech
910mm×660mm×1470mm; 68kg DICOM & EMR Connectivity Real-time 4D Volume Imaging Tech
Package: DICOM3.0 Compliant Expand-Pulse-Inversion Imaging Tech
1035mm×725mm×1535mm; 128kg DICOM Work-list Color Deflection Tech
DICOM Storage Free-hand 3D Imaging Tech
Conditions DICOM Structured Reporting Spatial-Compound Imaging Tech
Operating DICOM Print Pulse-Inversion Harmonic Imaging Tech
Temperature: 10°C~40°C DICOM Commit Imaging Parameters Preset
Humidity: 30%~75% Electronic Medical Record Custom Key/Optimization Key
Pressure: 50kPa~106kPa RIS HL7 Port
Shipping/Storage General Performance
Temperature: -15°C~50°C Image Storage Digital Broadband: 8192 channels
Humidity: 10%~90% Storage Format: Beam-former: Re-programmable
Pressure: 50kPa~106kPa PNG, AVI, MPEG, RAW (cine) Transmit Voltage: Adjustable (16 steps)
Export Video Format: Beam-former Frequency Range: 1~40 MHz
Connectivity/Media/Peripherals AVI, MPEG, DICOM
Transducer Ports: 4 (Activated)
USB Ports: 5
Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Add: Zoncare Building, 380#, High-tech 2nd road, Eastlake High-tech Development Zone, Wuhan, Hubei 430206 P.R.C.P
Tel: 86-27-87770203 Email: info@zoncare.com
Fax: 86-2787770581 Website: www.zoncare.com/en/
ZONCARE-Q9
Pan/Zoom Embedded Computer Geometric Focus Approx: 90 mm

Real-Time Image Zoom CPU:
Frozen Image Zoom Intel E4300 (Minimum) Micro-Convex Array Probe:
Read Zoom Range: 100%~500% Hard Drive (Patient) Data: Frequency:
Write Zoom Range: 100%~300% ≥ 500 GB Central 4 MHz
Up/Down/Left/Right Inversion Average Min. 3.6 MHz
Audio: Speakers Max. 4.4 MHz
ECG (Optional) Internal/External: Internal (stereo) Pitch: 0.28 mm
ECG Module Frequency Range: 200Hz~17 kHz Radius: 20 mm
ECG Lead Impedance: 4Ω Number of Elements: 128
ECG Invert Power: 5W Geometric Focus Approx: 90 mm
ECG Baseline Sound Pressure: 80 dB/W
ECG Gain Size: 105mm×35mm×20.3mm Linear Array Probe:
Frequency:
Hardware Specification UPS (Optional) Central 10 MHz
LED Monitor Voltage: 100V~240V Average Min. 7.2 MHz
Size (Diagonal): 19” Frequency: 50/60Hz Max. 8.8 MHz
Contrast Ratio: 1500:1 Current: 7.0A/4.0A Pitch: 0.390 mm
Resolution: 1024×768 pixels Runtime: > 90 minutes Radius: N/A
Brightness: 250 cd/m 2
Weight: 11kg Number of Elements: 128
Color Depth: 24bit Dimensions: 295mm×265mm×90mm Geometric Focus Approx: 30 mm
Rotate Angle: ± 90°
Grey Levels: 256 Imaging Performance Intra-Cavity Probe:
Startup Time (Max): Frequency:
Touch Screen Avg. <60 seconds Central 6.5 MHz
Size (Diagonal): 10.4” Preset Switching Time: Average Min. 5.85 MHz
Weight: 500g Avg. < 1 second Max. 7.15 MHz
Contrast Ratio: 600:1 Storage Time (Image to Disk): Pitch: 0.205 mm
Resolution: 1024×768 pixels Avg. < 0.5 second Radius: 10 mm
Brightness: 450 cd/m 2
Number of Elements: 128
Grey Levels: 64 Transducers Geometric Focus Approx: 35 mm
Input Signal: LVDS Convex Array Probe
Compatible with bare hands/thin medical Frequency: Phased Array Probe:
gloves (e.g., latex, vinyl, nitrile) Central 3.3 MHz Frequency:
Average Min. 3.15 MHz Central 2.5 MHz
Console Max. 3.85 MHz Average Min. 2.25 MHz
Console Adjustment: Pitch: 0.468 mm Max. 2.75 MHz
Tilt & Swivel Radius: 60 mm Pitch: 0.300 mm
Number of Elements: 128 Radius: N/A

ZONCARE-Q9
Diameter Reduction:
B/PW, B/CW, B B/Power, Dual B/Power
Point to Point
Dual Compound, B/Elasto, B B/Elasto
Number of Elements: 64 Area:
B B/TDI, Dual B/TDI
Geometric Focus Approx: 30 mm Cross, Ellipse, Trace,
B/C/M, B/C/PW, B/C/CW
Point to Point
B/Power/M, B/Power/PW, B/Power/CW
4D Volume Probe Area Reduction:
B/TDI/M, B/TDI/PW, B/TDI/CW
Ellipse/Ellipse, Ellipse/Trace,
Software Specifications Trace/Trace B-Mode
Software Languages Hip Angle Maps: 17
English D: d Ratio Focus Count: Max. 10
German Gain: 0~100%
Spanish Doppler Auto-Focus: Available
Italian Velocity: TGC: 8 Sliders
Czech Single, Double (PSV/EDV) Dynamic Range: 145dB
French Time/Slope: Depth: Max. 36cm
Russian Time/Distance/Slope Acoustic Power: 0 ~ (-15) dB
Simplified Chinese Trace: Chroma: 8
Brazilian Portuguese Point to Point, Trace, Range Grayscale Levels: 256
Auto-Trace: Frame Rate: > 500Hz
User Interface PSV, EDV, MV, AT, DT, RI, Max Steer Angle: 17.5°
Cine Playback PI, SD, VTI, PGr, MGr, HR Max. Line Density: 512
Multiple Arrows Persistence/ Frame Average: Up to 7
Configurable Worksheets Imaging Modes Spatial-Compound Imaging: 7, 3, 5 Lines
Exam Review Overview Top/Bottom/Left/Right Reverse
Pictograms (Body Marks) B, Dual B, Quad B Clarity Adaptive Speckle Reduction:
System Setup Menu M, Color M, Anatomical M Off, Low, Med, High, Max
Programmable Annotations Color, Dual Color, Simultaneous 2D/Color
Compound, Dual Compound M-Mode
Max Onscreen Measurements PW, CW, Triplex Maps: 16
Distance: 25 CFM, PD, Directional PD, CD Chroma: 17
Area: 12 Freehand 3D Sweep Speed: 3
Volume: 8 Standard 3D/4D, Advanced 3D/4D Anatomic M-Mode: Available
Panoramic, Elastography Gain: 0~100%
Measurement Tools Tissue Doppler Imaging (TDI) Distance: Point-to-Point
B-Mode Expand Pulse Imaging (EPI) Max Steer Angle: 15°
Distance: Diameter Reduction: Point-to-Point
Point to Point, Curve Combined Modes Heart Rate/Time/Distance/Slope
Angle: Dual B, Quad B, B/M, B B/C, Dual B/C Side-by-Side/Top/Bottom Layout
Vector Angle

ZONCARE-Q9
Color Mode Chroma: 17

Frames per Volume: 3~125
Gain: 0~100% Sample Volume Size: 0.5mm~40mm
Field of View (Max): 5°~75°
Color Maps: 9 Doppler Multi-Frequency:1.67MHz,
Max Volume Rate: 3
Color Visibility: Off/On 2MHz, 2.5MHz, 3.33MHz, 4MHz
Viewing Options: A/B/C/VR, A/VR,
Doppler Steer Angles: 5 Steps Auto-Trace, Baseline, Side-by-Side/Top/
C/VR, V
PRF: 0.2 kHz~10 kHz Bottom Layout, Invert, Duplex
Rendering Methods: Surface, Surface-
Wall Filter: 1-50% of PRF
Smooth, Maximum, X-Ray
Max. Steer Angle: 15° Freehand 3D Mode
Live 3D/4D imaging, One Sweep 3D,
Doppler Multi-Frequency: 2MHz~10MHz Maps: 17
Rendering 3D ROI, Multi-Slice,
Priority: 0~250 Rendering Quality: Low, Med, High
3D Niche Mode, Measurements,
Color Modes: Color & Power Methods: Parallel, Fan
Sculpt, Annotations, Contrast, Threshold,
Line Density Max: 256 Lines Frames per Volume: 3~125
Save Cine-loops, Save Volume
Persistence/Frame Average: Up to 9 Frames Line Density: 64~192
Baseline/Invert/Color ROI/M-Mode Field of View (Max): 5°~75° Compound
Viewing Options: A/B/C/VR, A/VR, Frame Count: 3 or 5 Lines (Tx/Rx)
PW Mode C/VR, V Focus Count: Max. 2
Gain: 0~100% Rendering Methods: Surface, Surface- Max Line Density: 256
Sweep Speed: 5 Smooth, Maximum, X-Ray Compound Levels: Med, High, Shine
Doppler Steer Angles: 5 Steps 3D ROI, 3D Niche Mode, Measurements,
Maps: 3 Sculpt, Annotations, Contrast, Threshold Panoramic
Max Steer Angle: 15° Max Length: > 0.8m
Spectrum Filter (Edge): 0~12 Standard 3D/4D Mode Zoom, Rotate, Pan: Available
Audio: 0~100% Maps: 17
Correction Angle: 80°/-80° Line Density: 64~192 Elastography (Optional)
Doppler Multi-Frequency: 2MHz~10MHz Rendering Quality: Low, Med, High Maps: 20
Chroma: 17 Frames per Volume: 3~125 Transparency: 0~100%
Sample Volume Size: 0.5mm~40mm Field of View (Max): 5°~75° Max Frame Rate: 30Hz
Auto-Trace, Baseline, Side-by-Side/Top/ Viewing Options: A/B/C/VR, A/VR, Region Selection: all, soft, med, hard
Bottom Layout, Invert, Duplex, Triplex C/VR, V ROI, Stiffness Display Filter, Strain Ratio
Rendering Methods: Surface, Surface-
CW Mode Smooth, Maximum, X-Ray Analysis Packages
Gain: 0~100% One Sweep 3D, 3D ROI, 3D Niche Mode, OB
Sweep Speed: 5 Measurements, Sculpt, Annotations, Cardiac
Doppler Steer Angles: 5 Steps Contrast, Threshold Abdominal
Maps: 3 GYN
Max Steer Angle: 15° Advanced 3D/4D Mode Urology
Spectrum Filter (Edge): 0~12 Maps: 17 Vascular
Audio: 0~100% Line Density: 64~192 Small Parts
Correction Angle: 80°/-80° Rendering Quality: Low, Med, High

ZONCARE-Q9
Measurements Specifications Vessel Dia, Stenosis Dia, HR

Compound/Dual Compound)
Abdomen (All Modes)
LA/Ao (M):
Abdomen: Vessel:
Ao Root, LA Diam, ACS, Ao Root Ampl,
Liver, GB, GBWT, CBD, Portal Vein, Vessel Area, Stenosis Area, Auto Trace,
ET, HR
Spleen, GB L/H/W PS, RI, S/D, Time, Manual Trace, ED, PI,
(M-Mode, Color M, Anatomical M)
(All Modes) Vessel Dia, Stenosis Dia, HR
LV Simps.:
Abdomen PW: (All Modes)
A4C Dias, A4C Sys, A2C Dias, A2C Sys,
Portal V, Hepatic A, RHV, MHV, LHV
HR
(All Modes) Breast
(B-Mode, Dual B/Quad B,
Lt/Rt Kidney: Left/Right Breast:
Compound/Dual Compound)
L, H, W, Cortex LtL1, LtL2, LtL3, LtL4, LtL5
Qp/Qs:
(All Modes) (All Modes)
LVOT VTI, RVOT VTI, LVOT Diam,
Lt/Rt Kidney PW:
RVOT Diam, HR
Lt/Rt Vel Prox/Md/Dist, Lt/Rt Trace Cardiac
(B-Mode, PW Doppler, CW Doppler,
Prox/Mid/Dist MV:
Triplex)
(All Modes) Diameter, MVA (Trace), HR RV/LV:
Lt/Rt Renal A.: (B-Mode, Dual B/Quad B, RVWd, RVDd, IVSd, LVDd, LVPWd,
Lt/Rt Vel Prox/Mid/Dist, Lt/Rt Trace Compound/Dual Compound) RVWs, RVDs, IVSs, LVDs, LVPWs, HR
Prox/Mid/Dist, Lt/Rt Upper/Mid/Lower MV (M): (B-Mode, Dual B/Quad B,
Pole D-E Excursion, E-F Slope, A-C, EPSS, Compound/Dual Compound)
(All Modes) HR
RV/LV (M):
Aorta: (M-Mode, Color M, Anatomical M)
RVWd, RVDd, IVSd, LVDd, LVPWd,
Prox/Mid/Dist Ao AP, Rt/Lt Iliac AP, MV (Color):
RVWs, RVDs, IVSs, LVDs, LVPWs, HR
Prox/Mid/Dist Ao Width, Rt/Lt Iliac Dist A, Dist B, A (Trace), PISA,
(M-Mode, Color M, Anatomical M)
Width, AAA L/H/W Diameter, HR
TV (Color):
(All Modes) (Color M, Simultaneous 2D/Color,
TV Diam, PISA, HR
Aorta PW: Dual Color, Color Doppler)
(Color M, Simultaneous 2D/Color, Dual
SMA, Celiac, Ao, Rt/Lt Iliact A/V MV (Doppler):
Color, Color Doppler)
(All Modes) Peak E, Peak A, PHT, MV VTI, MV Acc,
AV (CONT.EQ):
Bladder: A Dur, E Dur, IVRT, MR Peak, E/Ea, HR
LVOT Diam, LVOT Peak, LVOT VTI,
L, H, W, Blad Wall, Rt/Lt Ureter, (PW Doppler, CW Doppler, Triplex)
AV Peak, AV VTI, HR
Pre/Post-void L/H/W LV Mass A/L:
(PW Doppler, CW Doppler, Triplex)
(All Modes) EPI Area, Endo Area, LV Length, HR
AV (Doppler):
Prostate: (B-Mode, Dual B/Quad B,
LVOT Peak, LVOT VTI, AV Peak, AV
L, H, W Compound/Dual Compound)
VTI, AR PHT, End Dias.Vel, LVOT
(All Modes) LA/Ao:
Diam, HR
Dor.PenA: Ao Root, LA, Asc Ao, LVOT Diam, AVA
(PW Doppler, CW Doppler, Triplex)
Vessel Area, Stenosis Area, Auto Trace, (Trace), HR
MV (Doppler):
PS, RI, S/D, Time, Manual Trace, ED, PI, (B-Mode, Dual B/Quad B,
Peak E, Peak A, PHT, MV VTI, MV Acc,

ZONCARE-Q9
A Dur, E Dur, IVRT, MR Peak, E/Ea, HR Uterus:

Lt/Rt Ovary:
(PW Doppler, CW Doppler, Triplex) Uterus L/H/W, Endom Thick, Fibroid 1
Lt/Rt Ovary L/H/W, Cyst 1 L/H/W, Cyst
PV (Doppler): L/H/W, Fibroid 2 L/H/W
2 L/H/W
PV Peak, PV VTI, PV AccT, RVOT VTI, (All Modes)
(All Modes)
RV ET, RV AcT, RV PEP, PR Peak, HR
Lt/Rt Follicle:
(PW Doppler, CW Doppler, Triplex) OB 2nd~3rd Trimesters
F1~F30
TV (Doppler): AFI:
(All Modes)
TV Peak E, TV Peak A, TV PHT & Dec, Q1, Q2, Q3, Q4
Uterus:
TV VTI, TV Acc, TR Peak, TR VTI, HR (All Modes)
Uterus L/H/W, Endom Thick, Fibroid 1
(PW Doppler, CW Doppler, Triplex) Fetal Heart:
L/H/W, Fibroid 2 L/H/W
Pulm.Vein: FHR
(All Modes)
PulmV PeakS, PulmV PeakD, PulmV (All Modes)
Uterine D:
PeakA, PulmV A Dur, HR Early OB:
Auto Trace, PS, RI, S/D, Time, Manual
(PW Doppler, CW Doppler, Triplex) GS, CRL, YS, NT, BPD, CxLength
Trace, ED, PI, HR
(All Modes)
(All Modes)
OB 1stTrimester Long Bones:
Vessel:
Fetal Biometry: HL, UL, TL, FL, Radius, Fibula
Auto Trace, PS, RI, S/D, Time, Manual
BPD, HC, OFD, FL, AC, TAD, APAD, (All Modes)
Trace, ED, PI, HR
CxLength, CEREB, FTA, TTD, APTD, Maternal Doppler:
(All Modes)
Nasal, BND Lt/Rt Uterine Artery
(B-Mode) (All Modes) Small Parts
Early OB: Fetal Biometry: Lt/Rt Testicle:
GS, CRL, YS, NT, BPD, Cx Length BPD, HC, OFD, FL, AC, TAD, APAD, L, H, W
(All Modes) CxLength, CEREB, FTA, TTD, APTD, (All Modes)
Fetal Doppler: Nasal, BND Lt/Rt Nodule:
FHR, Umb A, Umb A-PI, MCA, (All Modes) L, H, W, Isthmus, 1 T, 1 A/P, 1 L, 2 T,
MCA-PI, SD Ratio Fetal Doppler: 2 A/P, 2 L, 3 T, 3 A/P, 3 L, 4 T, 4 A/P, 4 L
(All Modes) FHR, Umb A, Umb A-PI, MCA, (All Modes)
Fetal Heart: MCA-PI, SD Ratio Lt/Rt Thyroid:
FHR (All Modes) L, H, W, Isthmus, Trans, A/P, Sag,
(All Modes) Isth Nod 1 T, Isth Nod 1 A/P,
Maternal Doppler: Pelvic Isth Nod 1 L, Isth Nod 2 T,
Lt/Rt Uterine Artery Fetal Heart: Isth Nod 2 A/P, Isth Nod 2 L
(All Modes) FHR (All Modes)
Lt/Rt Ovary: (All Modes) Vessel:
Lt/Rt Ovary L/H/W, Lt/Rt Cyst 1 L/H/W, Ovarian D: Vessel Area, Stenosis Area, Auto Trace,
Lt/Rt Cyst 2 L/H/W Auto Trace, PS, RI, S/D, Time, Manual PS, RI, S/D, Time, Manual Trace, ED, PI,
(All Modes) Trace, ED, PI, HR Vessel Diam, Stenosis Diam, HR
(All Modes) (All Modes)

ZONCARE-Q9
Urology Dual Compound)

Power cord/grounding cable
Dor.PenA: Stenosis A:
Fuse (2)
Vessel Area, Stenosis Area, Auto Trace, Lt/Rt Prox/Mid/Dist CCA,
User’s Manual
PS, RI, S/D, Time, Manual Trace, ED, PI, Lt/Rt Prox/Mid/Dist ICA,
Coupling Gel (0.25L)
Vessel Dia, Stenosis Dia, HR Lt/Rt Bulb
(All Modes) (B-Mode, Dual B, Quad B, Compound, Optional Accessories
Prostate: Dual Compound) 17” LCD Monitor
L, H, W Stenosis D: 4D Imaging Module
(All Modes) Lt/Rt Prox/Mid/Dist CCA, Elastography Module
Lt/Rt Testicle: Lt/Rt Prox/Mid/Dist ICA, Convex Array Probe
L, H, W Lt/Rt Bulb Micro Convex Array Probe
(All Modes) (B-Mode, Dual B, Quad B, Compound, Linear Array Probe
Lt/Rt Kidney: Dual Compound) Phased Array Probe
L, H, W, Cortex Arterial: Intra-cavity Probe
(All Modes) Distance, Area, HR, Velocity, 4D Volume Probe
Lt/Rt Kidney PW: Time/Slope, Trace, Range, Diam Red, DICOM 3.0
Lt/Rt Vel Prox/Md/Dist, Area Red, d:D Ratio, Diameter, Pedal Switch
Lt/Rt Trace Prox/Mid/Dist Mean Velocity Laser, Ink-jet Printer
(All Modes) (All Modes) Puncture Trestle
Lt/Rt Renal A.: Lt/Rt Carotid: Barcode Reader
Lt/Rt Vel Prox/Mid/Dist, Lt/Rt Prox/Mid/Dist CCA, ECG
Lt/Rt Trace Prox/Mid/Dist, Lt/Rt Bulb, Lt/Rt Prox/Mid/Dist ICA, UPS
Lt/Rt Upper/Mid/Lower Pole Lt/Rt Prox/Mid/Dist ECA, Lt/Rt Vert Art,
(All Modes) Lt/Rt Sub Clav Certificates
Bladder: (All Modes) Quality Standards
L, H, W, Blad Wall, Rt/Lt Ureter, Venous: ISO9001
Pre/Post-void L/H/W Lt/Rt GSV Prox/Mid/Dist, ISO13485
(All Modes) Lt/Rt SFV Prox/Mid/Dist, CMD
Vessel: Lt/Rt CFV, Lt/Rt POPV, CE
Vessel Area, Stenosis Area, Auto Trace, Lt/Rt LSV Prox/Mid/Dist, Distance, CE Declaration
PS, RI, S/D, Time, Manual Trace, ED, PI, Time ZONCARE-Q9 has been assessed with
Vessel Dia, Stenosis Dia, HR (All Modes) respect to the conformity assessment
(All Modes) procedure described in Article 11.3.a and
Standard Package Annex II excluding section 4 (Module H) of
Vascular Main unit (with 19” LED Monitor) Council Directive 93/42/EEC on Medical
Intima: 10.4’’ LED touch screen operation Devices, as amended, and found to comply
IMT, Lt/Rt Prox/Mid/Dist CCA, Gel Heater (Notified Body No.: 0434)
Lt/Rt Bulb Convex Probe
(B-Mode, Dual B, Quad B, Compound, 3D Imaging Module/Software


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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

NOMOR IZIN EDAR

KEMENKES RI AKL 21501312398

Kategori Produk : Peralatan Radiologi

Sub Kategori : Peralatan Radiologi Diagnostik

Jenis Produk : Ultrasonic pulsed doppler imaging system.

Tipe / Ukuran : ZONCARE-Q9

Atas dasar lisensi dari : -

Jakarta, 09 September 2019

No. Deskripsi Tipe / Kode

Jakarta, 09 September 2019

System Overview Hard Disc: ≥ 320GB

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Pan/Zoom Embedded Computer Geometric Focus Approx: 90 mm

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Color Mode Chroma: 17

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Measurements Specifications Vessel Dia, Stenosis Dia, HR

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

A Dur, E Dur, IVRT, MR Peak, E/Ea, HR Uterus:

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

Urology Dual Compound)

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

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