KEMENTERIAN KESEHATAN RI

DIREKTORAT JENDERAL PELAYANAN KESEHATAN

RUMAH SAKIT UMUM PUSAT SANGLAH DENPASAR
Jalan Diponegoro Denpasar Bali ( 80114 )
Telepon. (0361) 227911-15, 225482,223869, Faximile. (0361) 224206
Email : info@sanglahhospitalbali.com Website : www.sanglahhospitalbali.com
Denpasar, 14 Februari 2023

KAJIAN PENGADAAN ALAT MAMMOTOME EX BREAST BIOPSY AND

EXCISION SYSTEM

A. LATAR BELAKANG
· Kanker payudara merupakan jenis kanker yang menduduki peringkat pertama di
Indonesia. Dalam perencanaan penganggulangan dari kanker menurut WHO
perlu dilakukan beberapa upaya seperti kuratif, preventif dan promotif.
· RSUP Prof. Ngoerah merupakan rumah sakit yang telah telah di tetapkan oleh
Kementrian Kesehatan Republik Indonesia sebagai salah satu pusat pelayanan
kanker strata tiga yang dimana satu level di bawah Pusat Kanker Nasional/RSK
Dharmis Jakarta. Untuk melakukan pelayanan yang lebih optimal dan
meningkatkan Teknik diagnosis terutama pada kanker payudara di butuhkan alat
penunjang yang beragam, salah satu contohnya yaitu Msmmotome ex breast
Biopsy and Excicion System. Alat tersebut berfusing sebagai alat elektromekanis
biopsy payudara non radiasi yang digunakan untuk eksisi biopsy payudara,
sehingga meningkatkan pelayanan dalam mendiagnosis dini kanker payudara.

B. TUJUAN
a. Meningkatkan efesiensi dan akurasi dalam menunjang diagnosis kanker
payudara
b. Melengkapi fasilitas pelayanan kanker terpadu di RSUP Prof. I.G.N.G.
Ngoerah Denpasar.

C. KEBUTUHAN
2 unit MAMMOTOME ex Breast Biopsy and Excision System

D. SPESIFIKASI DAN PERKIRAAN HARGA

MAMMOTOME ex Breast Biopsy and Excision System
Tipe:
CF Applied Part, Class 1
1. Berat:
Komponen dan aksesoris 130kg

2. Mode Sistem
Intermittent operation with a duty cycle of 45 min. "ON" and 15 min. "OFF".
3. Elektrikal Specifications

Specification SCM 12 SCM 23

Operating Voltage
Operating Current
Operating Frequency
Agency Compliance
Patient Isolation
(Protection Against
Electrical Shock)
Operating Temperature
Operating Humidity
Operating Duty Cycle
Fuse Ratings
Degree of Protection Against
Ingress of Fluids
120V~ 220/240V~
6.3 Amps (Maximum) 3 Amps (Maximum)
60Hz 50/60Hz
CF CF
USA: UL 60601-1; Europe: IEC 60601-1, USA: UL 60601-1; Europe: IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-4; Canada: CSA C22.2 IEC 60601-1-2, IEC 60601-1-4; Canada: CSA C22.2
No. 601.1 No. 601.1
5°C - 40°C (41°F - ) 5°C - 40°C (41°F - 104°F)
104°F
30% to 75% Relative Humidity, Non Condensing
45 minutes ON, 15 minutes OFF 45 minutes ON, 15 minutes OFF
See Chapter 4, Repair and Replacement See Chapter 4, Repair and Replacement Procedures
System: IPXO System: IPXO
Footswitch: IP 68 Footswitch: IP 68

4. Elektromagnetic Emission

Emissions Test Compliance Guidance

RF Emissions CSPR 11 Group 1 The MAMMOTOME Biopsy System uses RF energy for its internal functions. Therefore, the
system RF emissions are loq and are not likely to cause any interference in nearby electronic
equipment.

RF Emissions CSPR 11 Class A The MAMMOTOME Biopsy System is suitable for use in establishments other than
domestic
and those directly connected to public low-voltage power supply networks.

Harmonic Emissions IEC 61000-3- N/A

2
Voltage Fluctuations, Flicker N/A

5. Elektromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level Guidance

Electrostatic ± 6kV Contact ± 6kV Contact Relative humidity should be
Discharge ± 8kV Air ± 8kV Air at least 30%

IEC 61000-4-2
Radiated RF 3 Vrms 80MHz to 2.5 GHz Portable and mobile RF
IEC 61000-4-3 communications equipment
Electrical Fast ± 2kV on Power Supply Lines ± 2kV on Power Supply Lines Mains power quality should
Transient/Burst be that of a typical
IEC 61000-4-4 ± 1kV on Input/Output Lines ± 1kV on Input/Output Lines commercial or hospital
environment.
Surge IEC ± 1kV on Differential Mode ± 1kV on Differential Mode Mains power quality should
61000-4-5 be that of a typical
± 2kV on Common Mode ± 2kV on Common Mode commercial or hospital
environment.
Conducted RF 3 Vrms from 150 kHz to 80 MHz 3 Vrms from 150 kHz to 80 MHz Portable and mobile RF
IEC 61000-4-6 communications
10 Vrms from 80MHz to 2.5 GHz 10 Vrms from 80MHz to 2.5 GHz equipment (cell phones)
should not be
used at close distances.
Power 3 A/m 3 A/m Power frequency magnetic
Frequency fields should be at levels
Magnetic Fields characteristic of a typical
IEC 61000-4-3 location in a typical
commercial or hospital
environment
Voltage Dips, Short < 5% UT (95% dip in UT for 0.5 cycles) < 5% UT (95% dip in UT for 0.5 Power frequency magnetic
Interrupts and cycles) fields should be at levels
variations on < 40% UT (60% dip in UT for 5 cycles) < 40% UT (60% dip in UT for 5 characteristic of a typical
Power Supply Lines cycles) location in a typical
IEC 61000-4-11 < 70% UT (30% dip in UT for 25 cycles) < 70% UT (30% dip in UT for 25 commercial or hospital
cycles) environment
 6. Alat ada di e-katalog LKPP.
https://e-katalog.lkpp.go.id/katalog/produk/detail/1443075?lang=id&type=general

7. Harga e-katalog : Rp 351.228.000,00

Kepala Instalasi Pelayanan Jantung Terpadu Ketua KSM Kardiovaskular

Dr.dr. Bagus Arie Pradnyana D.S, Sp.JP (K) dr.Hendy Wirawani, M.Biomed, SpJP
NIP. 197203272009121001 NIP.198402202019021001

Mengetahui,
Direktur Pelayanan Medis, Keperawatan, dan Penunjang

Dr. dr. Ni Ketut Ariawati,Sp.A(K)

NIP.196806131999032001