KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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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

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 20203915526

Nama Dagang / Merek : LEICA CM1520 - Cryostats and Accessories Kelompok / Kelas Resiko : Diagnostik In Vitro / B

Kategori Produk : Peralatan Hematologi dan Patologi Sub Kategori : Peralatan dan Asesori Patologi Jenis Produk : Automated slide stainer.

Tipe / Ukuran : Ref. No. CM1520

Kemasan : Dus, unit + aksesoris (terlampir)

Nama Produsen / Pabrikan : LEICA BIOSYSTEMS NUSSLOCH GMBH., Germany

Melalui LEICA MICROSYSTEMS (SEA) PTE., LTD., Singapore Nama Pendaftar : PT. BIOGEN SCIENTIFIC, DKI Jakarta

Atas dasar lisensi dari : - Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 31 Desember 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 dengan perubahan pada penandaan dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 20203915526 tanggal 4 November 2020.

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, 27 April 2022

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20203915526

No. Deskripsi Tipe / Kode

1 Easy Dip staining container, white 14 0712 40150

2 Easy Dip staining container, pink 14 0712 40151

3 Easy Dip staining container green 14 0712 40152

4 Easy Dip staining container, yellow 14 0712 40153

5 Easy Dip staining container, blue 14 0712 40154

6 Blue O-ring, for color marking, 20 mm and 30 mm, 10 pcs 14 0477 43247 7 Red O-ring, for color marking, 20 mm and 30 mm, 10 pcs 14 0477 43248 8 Blue O-ring, for color marking, 40 mm, 10 pcs 14 0477 43249 9 Red O-ring, for color marking, 40 mm, 10 pcs 14 0477 43250 10 Blue O-ring, for color marking, 55 mm, 10 pcs 14 0477 43251 11 Red O-ring, for color marking, 55 mm, 10 pcs 14 0477 43252

12 Toolset for cryostats 14 0436 43463

13 Specimen disc, 20mm 14 0370 08636

14 Specimen disc, 25 mm 14 0416 19275

15 Specimen disc, 30 mm 14 0370 08587

16 Specimen disc, 40 mm 14 0370 08637

17 Specimen disc, 55 mm 14 0419 26491

18 Specimen disc, 50 x 80 mm 14 0419 26750

19 Heat extractor 14 0471 30792

20 Parking station 14 0471 30793

21 Heat extractor - mobile 14 0443 26836

22 Transfer block for specimen discs, small (holder for specimen discs) 14 0491 47787 23 Transfer block for specimen discs, large (holder for specimen discs) 14 0491 47786

24 Thermal block 14 0398 18542

25 Miles adapter, for TissueTek specimen discs 14 0436 26747

26 Plug adapter set EU-UK 14 0411 45349

27 Shelf, movable, assembly 14 0491 46750

28 Add-on kit: Swing arm with anti-roll guide system 14 0419 35693 29 Anti-roll guide system CE, glass - 70 mm, 100 µm spacer for 5 - 50

µm

14 0419 33980

30 Anti-roll guide system CE, glass - 70 mm, 50 µm spacer for up to 4 µm

14 0419 37258

31 Anti-roll guide system CE, glass - 70 mm, 150 µm spacer for over 50 µm

14 0419 37260

32 Anti-roll guide system for knife holder CN or CN-Z, for 5 µm - 50 µm 14 0419 33981

33 Glass insert, glare-reducing, 70 mm wide 14 0477 42497

34 Glass insert - 50 mm 14 0419 33816

35 Embedding medium for cryosectioning 14 0201 08926

36 Cryostat oil - Type 407, 250 ml 14 0336 06100

Lampiran 1 dari 2 Halaman

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

No. Deskripsi Tipe / Kode

37 Leica Cryofect - low-temperature disinfectant, 4 x 350 ml 14 0387 42801

38 Safety gloves, cut-resistant, size S 14 0340 40859

39 Safety gloves, cut-resistant, size M 14 0340 29011

40 Strop.back kn.16 cm b&c 14 0337 08687

44 Handle f. knives 10-30 cm 14 0283 08504

45 Hon.stone fine yl 25x5.5 14 0210 04070

46 Hon.stone bl-gr 25x5.5 cm 14 0210 04071

47 Metal case f. hon.stones 14 0210 04073

48 Strop block 'Heidelberg' 14 0209 04066

49 Clamp f.strop block HD 14 0285 07057

50 Strop paste, red 14 0209 04064

51 Power cords 100v/50-60Hz 14049148255

52 Power cords 120V/60Hz 14049148055

53 Power cords 120V/60Hz 149491520U1

54 Power cords 230V/60Hz 14049148056

55 Power cords 230V/50Hz 14049148053

56 Power cords 230V/50Hz 149491520E.1

57 Power cords 240V/50Hz 14049148054

58 Case with cryoembedding system 14 0201 40670

59 Cryoembedding system 14 0201 39115

60 Embedding well bar set with small recesses, 18mm 14 0201 39116 61 Embedding well bar set with medium-sized recesses, 24 mm 14 0201 39117 62 Embedding well bar set with large recesses, 30 mm 14 0201 39118 63 Freezing griddle/elevated freezing block set 14 0201 39119

64 Embedding well bar, 4 x 18 mm 14 0201 39120

67 Embedding well bar, 2 x 20 x 6 mm, 2 x 20 x 9 mm 14 0201 46662 68 Embedding well bar, 2 x 24 x 6 mm, 2 x 24 x 9 mm 14 0201 46663

69 Specimen stage, rectangular, 28 mm 14 0201 39123

70 Specimen stage, rectangular, 36 mm 14 0201 39124

71 Heat extractor 14 0201 39125

72 Container for specimen stages 14 0201 39126

73 Dispensing slides for Dr. Peters' cryoembedding system, pack of 8 14 0201 39127

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

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Lampiran 2 dari 2 Halaman Jakarta, 27 April 2022

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Nama Produk Diproduksi oleh Melalui Distribusi oleh

KEMENKES RI AKL

: LEICA CM1520 - Cryostat and Accessories : LEICA BIOSYSTEMS NUSSLOCH GMBH

Heidelberger Strase 17-19 D-69226 Nussloch, Germany : LEICA MICROSYSTEMS ⁽SEA⁾PTE LTD

12 Teban Gardens Crescent Singapore : PT. BIOGEN SCIENTIFIC

Rukan Tanjung Mas Raya

Jl. Raya Lenteng Agung Blok B1 No.21 Jakarta Selatan 12530 Indonesia : 2 0 2 0 3 9 1 5 5 2 6

CM1520 - ^Cryostat

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Cryochamber

Refrigeration capacity¹ 690 W

Safety factor 3

Quick‑freeze shelf

TECHNICAL DATA CM1520

Type CM1520 CM1520 CM1520 CM1520 CM1520

Nominal voltage 100 VAC ±10 % 120-127 VAC

±10 % 230 VAC ±10 % 220-230 VAC

±10 % 240 VAC ±10 %

Nominal frequency 50/60 Hz 60 Hz 60 Hz 50 Hz 50 Hz

Power input 1440 VA 1440 VA 1440 VA 1440 VA 1440 VA

Max. start-up current

for 5 s 45 A eff. 45 A eff. 45 A eff. 45 A eff. 45 A eff.

Heat emmision (max.) 1600 J/s 1600 J/s 1600 J/s 1600 J/s 1600 J/s

Operating temperature range (ambient tempera-

ture) 18-35 °C 18-35 °C 18-35 °C 18-35 °C 18-35 °C

All specifications related to temperature of the cooling unit are valid only for an ambient temperature of 22 °C and a relative humidity of no more than 60 %!

Refrigeration system (50/60 Hz)

Temperature range 0 °C to -30 °C (+ 3 K/- 3 K)

Defrost Automatic hot gas

defrost 1 automatic defrost cy- cle/24 hours, time- controlled (duration 12

min.) Electric coarse feed slow 600 μm/s

rapid 900 μm/s

Refrigerant 300g ±5g refrigerant R 404A

Maximum cooling - 35 °C (+ 3 K/- 5 K)

Defrost Manual hot gas defrost, time- controlled (duration 12 min.)

1 according to CECOMAF Liquid temperature 45 °C, evaporation temperature -25 °C Number of freezing stations 10

Compressor oil 0,6 l EMKARATE RL-22S, ICI Cooling time down to -30 °C max. 6 hrs., at 22 °C ambient

temperature

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Microtome

Type Rotary microtome

Cryocabinet Dimensions Section thickness selec-

tion 2 - 60 μm Width (w/o handwheel) 600 mm

Total specimen feed 25 mm Width (with handwheel) 730 mm

Vertical stroke 59 mm Depth 730 mm

Maximum specimen size 55 x 55 mm or

50 x 80 mm Hight 1140 mm

Specimen orientation 8° (x-, y-, z-Achse) Weight (incl. microtome,

without specimen cooling) approx. 135 kg Electric coarse feed slow 600 μm/s

rapid 900 μm/s

Lamp Storage conditions

50 Hz version Osram Dulux S 11 W/21

Color: LUMILUX light white Temperature 5 - 50 °C 60 Hz version Osram Dulux S 13 W/21

Color: LUMILUX light white Humidity < 80 %,

non-condensing Transport temperature -40 °C to +55 °C

All CM1520 instrument variants need the following secondary fuses

F1 T0.25A L250V Type FST 6.3x32 Firma SCHURTER F2 T1.6A L250V Type FST 6.3x32 Firma SCHURTER F3 T1.0A L250V Type FST 6.3x32 Firma SCHURTER F4 T6.25A L250V Type FST 6.3x32 Firma SCHURTER

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Marking Plate LEICA CM1520

Label Nama Distributor Kemenkes RI AKL

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