FORM SPESIFIKASI

I DATA ADMINISTRASI (*
JENIS PRODUK : ESWL ( Extracorporeal Shock Wave Lithotripsy)
NAMA PRODUK : RICHARD WOLF ESWL LITHOTRIPTER 3000 (incl. C-Arm, USG, Treatment table)
MODEL/TIPE PRODUK : LITHOTRIPTOR 3000
NO. REGISTRASI DAN MASA BERLAKU : AKL 20805028229
NAMA SOLE AGENT : PT. SURGIKA ALKESINDO
ALAMAT SOLE AGENT : Jl. Letjen. Suprapto No. 60 Gd. Indra Sentral unit G-H, Cempaka Putih, JakPus
PHONE/ FAX. / E-MAIL : (021) 4253634
NAMA PABRIK : RICHARD WOLF GmbH, GERMANY
RICHARD WOLF GmbH 75438 Knittlingen,Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49
ALAMAT PABRIK :
70 43 35-300, info@richard-wolf.com, www.richard-wolf.com
* seluruh data izin edar sesuai izin registrasi

Data administrasi diisi sesuai dengan data yang tercantum dalam izin edar

II DATA SPESIFIKASI (*
(*untuk informasi spesifikasi lain yang dimiliki alkes semua dimasukan
kedalam informasi tambahan
INFORMASI PRODUK PRODUK

COUNTRY OF ORIGIN Germany

FACTORY OF ORIGIN Germany
OUTSOURCE EXTERNAL MANUFACTURE (OEM) Germany
PRODUCT'S REGISTRATION (AKL/AKD) AKL 20805028229
PRODUCT'S CERTIFICATION
FDA Clearance yes
CE Mark (MDD) yes
Certificate ISO 13485 yes
Certificate ....
(* informasi produk di isi sesuai dengan yang dimiliki oleh produk tersebut

Features:
RICHARD WOLF ESWL LITHOTRIPTER 3000 LITHOTRIPTER 3000 with triple focus for optimum stone fragmentation , dual localization X-ray
and inline USG, Worldwide, the only direct focusing lithotriptor (DFL)
Extremely effective, precise and quiet Unique, direct focus lithotripter with piezo two-layer
technology. High dynamic range for low, medium and high energy applications Low, medium and
high energy treatment, Triple focus Individually selectable focus, because no two stones and no two
patients are alike.
Dual simultaneous real-time location (DSR): The ultimate in precision location

Painless due to especially wide aperture angle. The piezo technology allows the therapy source
to be designed with an extremely wide aperture angle of 74°. This reduces the energy density at the
skin’s surface: treatment is sparing and efficient and anesthesia is rarely needed. Treatment possible
without anaesthesia or sedation
Inline ultrasound location for fast and safe kidney stone location
Outline X-ray location for low-radiation urinary stone location

TECHNICAL DATA :
Generator Shock Wave
Type generator Shock Wave : Piezoelectrical
Description : Extracorporeal Shockwave - Lithotripter with High performance long life
Shock Wave Source dual localization : x-ray and inline USG
Main Supply : 220 - 240 v / 50- 60 Hz
Technology : High Perfomance Shock-wave source with self-focusing with double layer
with 5.000.000 shock waves warranty or 2 year utilization
Range of the source : Therapy area +/-50º ( 100º) isocentric for individual coupling of the patient
Aperturangle : 74º ( for large Coupling Area : Treatment without anaesthesi and sedation )
Foccussize : 3 different Focus sizes ( Triple Focus )( Min/Med/Max )
approx. Ø 2 ,4 ,8 mm ( More effictive treatment through suitable focus sizes to avoid side
effects )
Energy dosage : 20 level Intensity steps
Frequency : single pulses or multiple pulses of 30-360 shock waves per minute and ECG synchronization
Max. peak pressure : 126 MPa
Max. pulse energy : 140 mJ
Penetration depth : 165 mm centrally / 200 mm distally (-6dB)
Location : (DSR) Dual Simultaneous real time, Location : the ultimate in precision location,
No restrictions and interruption of the therapy during x ray and ultrasound location
X-ray Location : Confocal isocentric alignment to the focus of treatment , Lateral rotation of +/- 30°
Continuous inline ultrasound monitoring without radiation
exposure and without interrupting the shockwave treatment
Ultrasound location :
possible , Coaxial isocentric inline ultrasound localization with rotation
of +/- 90°
Treatment Table

Description : Mobile comfortable treatment table for patient positioning in lithotripsy and endourology
Table area dimensions : Length 2550 mm,Width 700 mm
Climbing hight : 750 mm
Travel range : Transversal 120 mm, Longitudinal 120 mm, Vertikal 200 mm
Transverse rate : 6 - 10 mm/sec.
Table tilt : ± 15° Trendelenburg
X- ray : Lithotripsy and endourological therapy area
Free space : +/- 30° for c- arc rotation
Control panel : With spiral cable and zero setting

C-Arm

Description : Compact mobile digital C- arm

Target cross : Electronic target cross
X- ray generator : 20 kHz high frequency generator up to 110kVp, Stationary anode
Monitor : 24" TFT split-screen monitor, high resolution , 1k x 1k high-contrast camera in full-frame
:
technology
Control : Text and symbol keyboard
Printer : B/W Printer integrated at the back of the monitor
Memory 10.000 Images
Accessories : 2 pedal footswitch, hand switch
USG

Feature 2 Active Probe Ports

Probes : convex probe
Probe Connections : 2 Probe Connetors for option
Printer : B/W printer
Input Connections : USB port