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 20102023689

Nama Dagang / Merek : HUMAN HumaStar 600 and Accessories

Kelompok / Kelas Resiko : Diagnostik In Vitro / B

Kategori Produk : Peralatan Kimia Klinik dan Toksikologi Klinik

Sub Kategori : Peralatan Laboratorium Klinik

Jenis Produk : Instrumentation for clinical multiplex test systems.

Tipe / Ukuran : Ref. No. 16660

Kemasan : Dus, unit + aksesoris (terlampir)

Nama Produsen / Pabrikan : DIATRON MI ZRT., Hungary
Untuk HUMAN GESELLSCHAFT FUR BIOCHEMICA UND
DIAGNOSTICA MBH, Germany
Nama Pendaftar : PT. SALI POLAPA BERSAMA, DKI Jakarta

Atas dasar lisensi dari : -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 08 November 2027.
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 20102023689 tanggal 6 Juli 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, 10 Maret 2023

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 20102023689

No. Deskripsi Tipe / Kode

1 USB-RS232-adapter 16660/251
2 Sample segment diameter max. 16 mm 16660/254
3 Sample segment diameter max. 13 mm 16661/15
4 ISE module field installation kit for Na, K, Cl 16663-03
5 Laser printer 18993L
6 TFT screen 17901M
7 LCD touchscreen monitor 18991MT
8 Personal computer with Windows 18992P
9 Sample Cups 2 ml 500 pcs 17470/59

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

Jakarta, 10 Maret 2023

Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
 Gesellschaft für Biochemica
und Diagnostica mbH

Max-Planck-Ring 21
65205 Wiesbaden ∙ Germany

Telefon +49 6122 9988-0

Telefax +49 6122 9988-100

Manufacturer’s Declaration
on
Packaging Components used concerning
HumaStar 600
(REF 16660)

We,
HUMAN Gesellschaft für Biochemica und Diagnostica mbH,
Max-Planck-Ring 21, 65205 Wiesbaden, Germany,

hereby declare that our packaging for REF 16660 is made of materials for which the compatibility with
the products has been verified in order to ensure the stability and tightness of the filled/packed items.

The following list provides a summary of the respective packaging:

Dimension
Secondary
Component Primary packaging Material Material (length x width x height)
packaging
Net weight

HumaStar 600
Transparent foil plastic
without ISE

User Manual

Accessories
Carton boxes, labelled paper
HumaStar 600

packed in 137.5 x 84.5 x 136.5 cm

all components wooden box, wood Net weight: 180
labelled kilogram

Wiesbaden, January 12, 2023

Geschäftsführer:
Dr. Björn Breth GLN 40 33145 000006
Vorsitzender des Beirats: USt-IdNr.: DE113854181 www.human.de
Lorenz von Schröder RG: Wiesbaden HRB 10782 Mail: human@human.de
1 of 4
Pictures:

2 of 4
3 of 4
4 of 4
Diimpor dan diedarkan oleh:
PT. SALI POLAPA BERSAMA
JAKARTA – INDONESIA
KEMENKES RI AKL……….
Keterangan Lebih Lanjut Hubungi :
PT. Sali Polapa Bersama
Puri Sentra Niaga Blok B 33-34, Jl. Raya Kalimalang, Jakarta Timur 13620
Telp. (021) 8626511
Fax. (021) 8626510

Diproduksi oleh :
Diatron MI Zrt.
H-1097 Budapest,
Tablas utca. 39. Hungary

Untuk:
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21, 65205 Wiesbaden, Germany
appendIx 113

12 APPENDIX

12.1 Technical Specification

450 tests/hour double reagent, 550 tests/tour
TABLE 18
Throughput mono reagent, max. 720 tests/hour with optional
ISE unit.
Analysis Modes End point with sample or reagent blank.
Factor or standard.
Priority selection by sample (profile) or by reagent
(batch).
Calibration curve with any number of standards.
Automatic curve fit, multipoint, logit 4/5, etc.
Turbidimetry.
Fast and two-point kinetics (zero and first order).
Routine, batch, STAT procedures, profiles.
Enzymes. Drugs.
Automatic sample dilution on abnormal levels, ex-
cessive substrate consumption and/ or lack of line-
arity. Automated reflex testing.
Full quality control: Levy-Jennings and Twin plots,
Westgard rules.
Import/export data, methods and historic files.
Automatic backup procedure.
Test selection, automatic calibration, calibration
curve multipoint calibration, polygonal.
Sample blank compensation, calculated tests,
Quality control, auto re-run, record of calibration,
data storage (historic results).
Automatic pre-dilution and post-dilution (ratio 1:5
to 1:100)
Stat: Highest priority in operation.
Continuous sample load.
Decontaminating post wash.
Sampling and Sample volume: 2 to 100 µL/test (in increments of
reagent Samples 0.2 µL.
Sample Tray: 95 (5 racks x 19 positions) ID bar code
equipped positions for routine, stat and control
samples and standard solutions.
Primary tube (length up to 100 mm), Pediatric vial
 114

Reagents Maximum number of simultaneous tests: 24 dou-

ble to 48 single reagent tests + 3 with optional ISE
unit.
1 to 3 reagents, 5 to 500 µL/test each (in incre-
ments of 1 µL), final total solution volume 180 to
500 µL/test
Reagent bottles capacities: 20 and 70.
Reagent cooling compartment: 48 cooled posi-
tions. Multiple vials per test.
Reagent temperature 9°C+/-2°C for room temper-
ature between 15 and 26°C.Above 26°C, 16°C+/-
1°C below room temperature.
Reaction Water consumption: 3 L / hour.
Warm air incubator: 37°C.
Reaction cuvette: re-usable plastic 6 mm light path
with 6-stage washing
Reaction time: 0 to 10 min.
Reaction temperature: 37°C ± 0.1°C.
Stirring: After dispensing each reagent.
Optics Double beam
Photometric Range: -0.1 to 3.6 A.
Measuring wavelength: 340 to 800 nm (selectable
among 12 wave-lengths). Photometry: Single or
Double-wavelength simultaneous reading.
ISE Unit Na+, K+ and Cl- measurements.
Samples: serum or urine.
Data Management WindowsTM based Software.
Interface LIS: bi-directional RC 232 C, according to
ASTM 1394 requirements.
Printout Customer’s optimized (Analysis result, work list,
list of samples, Quality
Control, Calibration curves, etc.)
Environmental conditions -10 to 40°C, humidity 30 to 90%, pressure 600 to
Transportation and storage 1050 hPa.
Use: 15 to 30 °C, humidity 40 to 80%, pressure 600
to 1050 hPa.
Power Requirements 110/220V, 50/60 Hz, 2.0 kVA
Dimensions (WxDxH): Instrument without
100 x 74 x 113 cm
any components:
Space required for
162 x 128 x 160 cm
routine use:
Packaging: 135 x 86 x 135 cm
Weight: Gross: 250 kg, Net: 180 kg.

HumaStar 600 | User manual