KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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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 20601915211

Nama Dagang / Merek : J. Morita Veraviewepocs 3D R100 Kelompok / Kelas Resiko : Elektromedik Radiasi / C

Kategori Produk : Peralatan Gigi

Sub Kategori : Peralatan Gigi Diagnostik Jenis Produk : Extraoral source x-ray system.

Tipe / Ukuran : X550

Kemasan : Unit

Nama Produsen / Pabrikan : J. MORITA TOKYO MFG.CORP., Japan Nama Pendaftar : PT. MORITA DENTAL INDO, DKI Jakarta Atas dasar lisensi dari : -

Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 24 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. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk tersebut, pendaftar bersedia mengembalikan izin edar.

4. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari persetujuan izin edar ini.

5. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau kembali.

Jakarta, 16 Agustus 2019

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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 12950 Telepon : (021) 5201590 Pesawat 2029, 8011

Faksimile : (021) 52964838 Kotak Pos : 203

Catatan:

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20601915211

No. Deskripsi Tipe / Kode

1 C O V E R

2 Arm Cover Operation Panel Side 6231859

3 Arm Cover Cassette Side EX2 6231864

4 Arm Cover, head side, top F40 EX 6231865

5 Arm Cover, head side, top F100 EX 6231866

6 Arm Cover Head Lower 6231804

7 Head Cover Front 6231805

8 Head Cover Back 6231806

9 Slide Cover Assembly 6231807

10 Harness Cable (#30,#75) 6211982

11 3Df 40 Sensor 6252620

12 3Df 100 Sensor 6252621

13 CONTROL BOX

14 Weight 6211901

15 Weight CP Type 6211902

16 Wire Cables 6350105

17 Wire Cables CP Type 6212002

18 Belt 6210096

19 Control Box Assembly EX2 6270940

20 Hanger 6270902

21 Control Box LED Board 6252501

22 Main Switch 6270192

23 Emission Switch Assembly 6270904

24 Pulley Axel 6211898

25 Wall Attachment Bracket Assembly 6211905

26 Base Cover 6211906

27 Base 6211907

28 Operation Cord 13m 6270906

29 Actuator A (FOR UPPER LIMIT) 6211908

30 Actuator A (FOR LOWER LIMIT) 6211909

31 Actuator B 6210126

32 E Ring 10 mm 5853160

33 Main Cover left 6211921

34 Main Cover right 6211922

35 Main Cover front 6211980

36 Back Cover, New EX 6212014

37 Back Cover CP Type, EX 6212015

38 Side Cover left 6212016

39 Bottom for Back Cover 6211919

Lampiran 1 dari 3 Halaman

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Catatan:

40 Side Cover right 6211926

41 Column Guide Collar A 6211927

42 Lower Cover 6211928

43 Front Cover 6211929

44 Mirror 6210064

45 Patient Frame Cover upper 6211931

46 Temple Stabilizer right, New 6211932

47 Temple Stabilizer left, New 6211933

48 Chin Rest 6211934

49 Temple Stabilizer Knob 6211935

50 Patient Frame Cover Lower EX 6212010

51 Patient Handle Cover left 6211937

52 Patient Handle Cover right 6211938

53 Patient Handle 6211939

54 Frame Membrane Switch 3813083

55 Frame LCD Panel 6252528

56 Securing Band A (with buckle) 6211957

57 Securing Band B 6211958

58 Bite Block Assembly 6211955

59 Bite Block (only) 6351080

60 Lip-nose Rest 6211956

61 Temple Stabilizer Set (left & right sides) New 6211970

62 Right Temple Plate, New 6211971

63 Left Temple Plate, New 6211972

64 Filter Board 6252504

65 Transformer 6212003

66 LAN Board B 6252605

67 Main Power Cord (reactor to power box) EX2 6270946

68 Slide Plate 6210038

69 Photo-interrupter 3011563

70 Emergency Switch 6211941

71 Mother 2 Board 6252506

72 Mother Board 4 6252529

73 Harness JCN1~ACN13 6211942

74 Harness JCN2~CCN1 6211943

75 Harness SCN1~ CP Type 6211944

76 Harness SCN4~PCN1 CP Type 6211945

77 Harness 6211966

78 Fuse 10A (SHV) 6310324

79 Power Board EX2 6252562

80 Switching Power Supply Board LDA100W-30-XMRTF 6252509

81 Switching Power Supply Board LDC30F-2-G 6252510

82 Switching Power Supply Board LDA100W-24-XMRTF 6252511

Lampiran 2 dari 3 Halaman

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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 12950 Telepon : (021) 5201590 Pesawat 2029, 8011

Faksimile : (021) 52964838 Kotak Pos : 203

Catatan:

83 Frame Board 6252602

84 X & Y axis Motor with coupling 6231863

85 Y-axis Motor Assembly 6230507

86 Photo-interrupter (with Cord) 6231817

87 Nut 6211962

88 Sagital Beam (also horizontal beam for cephalo) New 6330008

89 AF Sensor Assembly 6330015

90 Horizontal Beam 6330505

91 Drive Motor 6211973

92 Sagittal Beam 6330010

93 Lift Motor Assembly (with shaft) 6211975

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang tercantum dalam lampiran ini

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Lampiran 3 dari 3 Halaman Jakarta, 16 Agustus 2019

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Thinking ahead. Focused on life.

Local Distributor

KEMENKES RI No. ...

Ruko Roxy Trade Center Jl. KH. Hasyim Ashari No. 233K Cideng, Gambir - Jakata Pusat Telp. 021-58908372

J. Morita Veraviewepocs 3D R100 Manufacture By:

J. MORITA MFG. CORP.

680 Higashihama Minimi-cho, Fushimi-ku, Kyoto 612-8533, Japan

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Page 248 of 279 Report No. VDE 2159300-2882-0002/161987

Relevant pages of instruction for use APPENDIX III

TRF No. IEC60601_1G CB-Ref. No.: DE1-54315

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Page 250 of 279 Report No. VDE 2159300-2882-0002/161987

Relevant pages of instruction for use APPENDIX III

Marking Plate Patient frame

Rating label * Label contents may iffer depending on model.

Model

Serial Number Input power

CLASS I EQUIPMENT Type

Rated input voltage

Standby input power Supply frequency

Alternating current

Manufacturer Attention, consult accompany documents. Date

of manufactured Consult instruction for use

Type B applied part

CE(0197) marking

Conforms with the European Directive, 93/42/EEC.

CE marking

Conforms with the European Directive, 2011/65/EU.

Veraviewepocs 3D

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Model: X550

Type: EX-1, EX-2

Unit conﬁgurations: Veraviewepocs 3D R100 Pan (EX-1, EX-2 available Veraviewepocs 3D R100 Pan/Ceph in all conﬁgurations)

Input voltage: EX-1: AC 120V 60 Hz EX-2: AC 220/230/240V 50/60 Hz Power consumption: 2.3 kVA

Dimensions

Main unit: W 40.15" x D 51.18" x H 92.72"

(W 1,020 x D 1,300 x H 2,355 mm) With Cephalometric: W 78.74" x D 51.18" x H 92.72"

(W 2,000 x D 1,300 x H 2,355 mm)

Weight: Approx. 419 lbs.

(Approx. 190 kg)

Approx. 573 lbs. with Cephalometric

(Approx. 260 kg with Cephalometric)

X-ray generator

Tube voltage: 60-90kV (depending on exposure mode) Tube current: 1-10mA (depending on exposure mode) Effective focal spot: 0.5 mm

3D image

Exposure time: Approx. 9.4 seconds Tube voltage and current: Normal mode

1 - 10mA (1mA step) @ 75 - 80 kV (5kV step)

Dose reduction mode

3 - 8mA (1mA step) @ 85 - 90 kV (5kV step) 3D R100 imaging area: Ø 40 mm x H 40 mm

Ø 40 mm x H 80 mm Ø 80 mm x H 50 mm Ø 80 mm x H 80 mm

3D Reuleaux Full Arch FOV: Ø 100 mm (Equivalent) x H 50 mm Ø 100 mm (Equivalent) x H 80 mm

Exposure time: High speed mode: Approx. 7.4 sec. (Standard) High deﬁnition mode: Approx. 15 sec.

(High deﬁnition mode is available for R100 only) Imaging programs: Standard Panoramic (standard, orthogonal and shadow

reduction projections)

Magniﬁcation: 1.3 X throughout and 1.6 X throughout Pedodontic Panoramic (standard, orthogonal and shadow reduction projections)

Magniﬁcation: 1.3 X throughout and 1.6 X throughout Maxillary Sinus Panoramic (posterior and anterior) Magniﬁcation: 1.5 X throughout

TMJ Quadruple Image Magniﬁcation: 1.3 X throughout Partial Panoramic

Magniﬁcation: 1.3 X throughout Cephalometric image (option)

Projection: Posterior-anterior (PA) and Lateral (LA) Exposure time

PA projection

With variable imaging processing: 4.1 seconds Without variable imaging processing: 5.0 seconds Lateral projection

With variable imaging processing: 5.8 seconds,

4.2 seconds (partial ceph) Without variable imaging processing: 3.5 seconds,

2.6 seconds (partial ceph)

- Cephalometric is an optional feature.

- The Veraviewepocs 3D must be ﬁxed to the ﬂoor and the wall.

- Always have patients wear X-ray protective gear.

i-Dixel conforms to the following DICOM standards:

1. Modality worklist management service class 2. Storage service class

3. Modality performed procedure step service class 4. Print management service class

Clinical images provided by: Dr. Bruno Azevedo, Assistant Professor, University of Louisville School of Dentistry and Kitasenju Radist Dental Clinic, i-View Imaging Center, Japan.

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