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 21002716196

Nama Dagang / Merek : MEDTRONIC STEALTHSTATION S8

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Kategori Produk : Peralatan Neurologi

Sub Kategori : Peralatan Neurologi Bedah

Jenis Produk : Stereotaxic instrument.

Tipe / Ukuran : 9735666

Kemasan : Unit
Nama Produsen / Pabrikan : MEDTRONIC NAVIGATION, INC., United States
Untuk MEDTRONIC, INC., United States
Melalui MEDTRONIC INTERNASIONAL TRADING PTE., LTD.,
Singapore
Nama Pendaftar : PT. MEDTRONIC INDONESIA, DKI Jakarta

Atas dasar lisensi dari : -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 11 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. Izin edar ini merupakan persetujuan perpanjangan dengan perubahan alamat pemberi
penunjukan dan aksesoris dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL
21002716196 tanggal 12 Oktober 2017. 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, 16 November 2020

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.
 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 21002716196

No. Deskripsi Tipe / Kode

1 Emitter Flat 9733752
2 Emitter 9735521 side mount 9735521
3 Cart 9735665 Stealth S8 9735665
4 Cart 9735667 Stealth S8 9735667
5 Cart 9735668 S8 9735668
6 Cart 9735669 Stealth S8 9735669
7 StealthStation S8 Planning Station 9735894
8 Stealth S8 EM Cranial Accessory 9735955
9 Stealth S8 EM ENT Accessory 9735956
10 Stealth S8 EM Cranial Upgrade 9735957
11 Stealth S8 EM ENT Upgrade 9735958
12 Stealth S8 EM Cranial Flat Emitter 9735959
13 Stealth S8 EM ENT Side Emitter 9735960
14 StealthStation S8 zeiss Interface 9736023
15 StealthStation S8 zeiss pointer Only Interface 9736024
16 StealthStation S8 zeiss NC4 HUD Interface 9736026
17 StealthStation S8 Integration zeiss (Upgrade) 9736042
18 Camera Cart 9735670 Stealth S8 9735670
19 S8 EM Instrument Interface 9735825
20 StealthStation S8 ENT Software 9735736
21 StealthStation S8 Cranial Software 9735737
22 StealthStation S8 DBS Software 9735738
23 StealthStation S8 Stereotaxy Software 9735739
24 StealthStation S8 Spine Software 9735740
25 StealthStation S8 Stealthlink Software 9735744
26 StealtStation S8 Clinical Software application 9735762
27 StealthStation S8 Stealthlink Set Software 9735895
28 StealthStation S8 Stealthviz W/DTI Software 9735898
29 StealthStation S8 Stealthviz Software - multi 9735899
30 StealthStation S8 Stealthviz software - 60 day 9735900
31 StealthStation S8 Stealthviz software 9735913
32 S8 Planning Station Cranial Software 9735916
33 StealthStation S8 DBS Software 9735917
34 StealthStation S8 Stereotaxy Software 9735918
35 S8 Planning Station Spine Software 9735919
36 S8 Planning Station ENT Software 9735920
37 StealthStation S8 DBS + Stereotaxy Software 9735921
38 StealthStation S8 Stealthviz Software - Demo 9735929
39 StealthStation S8 Stealthviz Software - Internal 9735930
Lampiran 1 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

40 StealthStation S8 Microscope Autopositioning 9736025
41 StealthStation S8 Stealthviz software 9736048
42 SFW 9735745 S8 STEALTHMERGE 9735745
43 SFW 9735743 S8 STEALTH 3D 9735743
44 SFW 9735747 SCHALTENBRAND WHAREN ATLAS 9735747
45 SCU KIT 9735962 S8 PLUS UPGRADE 9735961
46 OPTICAL KIT 9735962 S8 PREMIUM UPGRADE 9735962
47 SFTWR 9730903 SFW, STEALTHMERGE PLUS 9730903
48 FOOTSWITCH 9731736 WITH CABLE, HC 9731736
49 SOFTWARE, 9732317, WIRELESS MOUSE 9732317
50 KIT, 9732319, SURGEON MOUSE 9732319
51 Power Pack StealthStation S8 UK 9735950
52 Stealth OS 2.0.X UPGRADE KIT SVC 9736356
53 SFW 9735742 STEALTH 3D ENT 9735742
54 SFW-9736155 S8 STEALTHMERGE ENT LICENSE 9736155
55 SFW KIT 9736350 STEALTH AIR 9736350
56 SFW 9736338 STEALTH SURGICAL THEATER CRL 9736338
57 SFW KIT 9736226 STEALTH FLEX ENT 9736226
58 SFW 9736227 FLEX ENT ADVANCED LICENSE 9736227
59 S8 OS Install CD 9736113
60 S8 Advanced Service Manual 9735627
61 S8 General Service Manual 9736198
62 Computer 9735764 NAV WITH PCOIP S8 SVC 9735764-G02
63 COMPUTER 9735786 NAVIGATION S8 SVC 9735786-G02
64 CABLE 9735803-G02 INTRNL MICROSCP S8 SVC 9735803-G02
65 NET 9735994 SEC APP-WIRED-CONFD S8 SVC 9735994-G02
66 COMPUTER 9736036 S8 PS SVC 9736036-G02
67 CABLE 9736371 VGA ADAPTER S8 SVC 9736371
68 CABLE 9736373 ETHERNET POWER 12V S8 SVC 9736373
69 DVD 9735991 SATA CABLE KIT S8 SVC 9735991
70 NET 9736401 SEC APP-WIRED UPGRD S8 SVC 9736401
71 CMPTR 9736403 NAV PCOIP UPGRD KIT S8 SVC 9736403
72 CMPTR 9736405 NAV UPGRADE KIT S8 SVC 9736405
73 ADAPTER USBC TO HDMI VIDEO SVC 9736408
74 ADAPTER DISPLAYPORT TO HDMI 4K SVC 9736409
75 CABLE HDMI TO DVI-D MTOM 3FT SVC 9736410
76 SSD 2.5IN 1TB S8 OS 2.0.X DUPED SVC 9736411
77 Power Pack SteatlthStation S8 Others 9735943
78 TRK KIT, 9732780, WRLESS, 9 IN, 9732780
79 TRK KIT, 9732779, WRLESS, 12IN, 9732779
80 TRK KIT, 9732778, WRLESS, 9 IN, 9732778
81 RK KIT, 9732776, WRLESS, 9 IN, 96-9800 9732776
82 StealthStation S8 integration leica (Upgrade) 9735963

Lampiran 2 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

83 StealthStation S8 leica HUD Interface 9736027
84 StealthStation S8 leica pointer Only Interface 9736028
85 INTF KIT 9736149 ZEISS KINEVO 9736149
86 9736150 S8 HUD 9736150
87 StealthStation S8 Integration 9736029
88 StealthStation S8 Integration 9736040
89 PIN, 9733236, 150MM, PERC REF 9733236
90 ARM 9733459 EMITTER HOLDER 9733459
91 CLAMP, 9733469, EMITTER HOLDER 9733469
92 PLNG STATION 9734048 STEALTHSTATION 9734048
93 SYSTEM, 9660651, AXIEM PORTABLE 9660651
94 INSTALL MEDIA 9735323 ENT TOOLS 9735323
95 INTFC KIT 9734339 HUD LEICA OH5 9734339
96 SOFTWARE 9733763 SYNERGY CRANIAL 9733763
97 SOFTWARE 9735585 STEALTHSTATION CRANIAL 9735585
98 SOFTWARE KIT 9733652 FUSION SW WITH PG 9733652
99 PIN, 9733235, 100MM, PERC REF 9733235
100 Emitter bracket support 9735547
101 Arm 9735702 side mount 9735702
102 Base S8 SVC 9735821
103 StealthStation S8 Integration 9736030
104 ACC 960-117 CD-REWRITABLE MEDIA 960-117
105 ACC 960-130 POSITION SENSOR UNIT 960-130
106 ACC 960-131 TOOL INTERFACE UNIT (TUI) 960-131
107 ACC 960-132 SENSOR CABLE 960-132
108 ACC 960-147 TOOL INTERFACE UNIT 960-147
109 ACC 960-147R TOOL INTERFACE UNIT- R 960-147R
110 ACC 960-148 POSITION SENSOR UNIT 960-148
111 SFTWR 960-152 MEDIA IO 960-152
112 ACC 960-160 STANDARD 5.25 INTERNAL MOD 960-160
113 ACC 960-418 VGA CABLE 25‘ 960-418
114 ACC 960-451 CAN232 CONTROL UNIT 960-451
115 ACC 960-730 EXTERNAL ODU CABLE NC4 MV 960-730
116 OPTICAL DRIVE 960160 960160
117 ACC 961-193 SERIAL CABLE RJ45-DB9 961-193
118 ACC 963-714 25‘ VID CABLE: OEC 9600 963-714
119 MODULAR DOVETAIL 963-738
120 ACC 963-809 CABLE VIDEO 8M/25‘BB 963-809
121 ACC 964-153 OPT. DRIVE 964-153
122 ACC 964-160 STANDARD 5.25 EXTERNAL MOD 964-160
123 ACC 9660215 DRF ASSM, PCA 9660215
124 CABLE CLIP, 9660245, AXIEM CRANIAL 9660245
125 ACC 9660900 EM BED EXTENSION 9660900

Lampiran 3 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

126 ACC 9680141 MODEM CABLE EXTERNAL 9680141
127 ACC 9680142 ETHERNET CABLE EXTERNAL 9680142
128 SYS 9680150 TREON OPTICAL NAV CART 9680150
129 ACC 9680159 TREON PSU 9680159
130 ACC 9680159R TREON PSU 9680159R
131 ACC 9680177 TREON BREAK-OUT-BOX 9680177
132 ACC 9680221 POWER SUPPLY 18 TOUCHSITE 9680221
133 C-ARM, ISO-C 3D WITH NAVILINK 9730428
134 C-ARM, ISO-C 3D, STAND ALONE 9730444
135 ACC 9730513 CASE, STORAGE, WIRELESS TRA 9730513
136 ACC 9730514 BATTERY, ISO-C WIRELESS TRA 9730514
137 ACC 9730598 JIG CALIBRATION 9730598
138 TRACKER KIT 9730634 TERATRACKER BLUE 9730634
139 TRACKER KIT 9730635 TERATRACKER GREEN 9730635
140 TRACKER KIT 9730636 TERATRACKER GOLD 9730636
141 TRACKER KIT 9730637 TERATRACKER PURPLE 9730637
142 CABLE, 12M-ZEISS LM10/ODU 9730643
143 CABLE, 16M-ZEISSZEA/LED 9730644
144 ACC 9730667 SENSOR CABLE, EXTERNAL 9730667
145 KIT, MTL HEADFRAME REPL SCREW 9730742
146 ACC 9730752 CABLE ADAPTER DVI 9730752
147 ACC 9730766 CABLE, S-VIDEO SPLITTER 9730766
148 ACC 9730822 BRACKET, MOUNTING PS JEROME 9730822
149 CABLE 9731113 OHS-1 LED LM12/LM12R 9731113
150 SYS 9731117 19 HI-BRITE MONITOR TREON 9731117
151 MONITOR 9731118 19” HIBRITE TRIA 9731118
152 KIT 9731175 HI-RES VIDEO OUTPUT OPT 9731175
153 FIELD GENERATOR 9731203 EM MOBILE 9731203
154 CABLE, 9731220 W/S PWR SUPPLY EU 9731220
155 Optical 9731225 NDI P4 9731225
156 optical, NDI P4 9731225R
157 BASE, 9731229 ASSY, optical STAND 9731229
158 ADAPTER, 9731231 CAM ARTICULATION MECH 9731231
159 WORKSTATION 9731238 50901CONFIG, EU 9731238
160 CABLE 9731243 CAM TO PWR SUPPLY 9731243
161 MONOPOLE 9731245 optical STAND 9731245
162 ATTACHMENT 9731449 BED RAIL 9731449
163 HOLDER 9731450 MOBILE LOCALIZER 9731450
164 CABLE, 9731454 ZEISS ZEA LED HC 9731454
165 ACC 9731516 N/A CABLE, CALIBRATION TARGE 9731516
166 TRACKER, 9731569, ISO-C CALIBRATION PHAN 9731569
167 CABLE, 9731605, COMPOSITE, BNC-RCA, 5M/1 9731605
168 CABLE 9731606 COMPOSITE RCA-RCA 5M/2 9731606

Lampiran 4 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

169 CABLE 9731798 DVI-M TO HD15-F SHORT 9731798
170 CASE, 9731826, EM 9731826
171 DRAPE 9731831 SPINE FIELD 9731831
172 DRAPE 9731831XOM EMITTER COVER 9731831XOM
173 DRIVER 9731833 1/4IN BALL HEX 9731833
174 POWER SUPPLY 9731843 ASSY-9VAC 30W 9731843
175 CABLE 9731858 PWR- MEDIA DRIVE EXT 9731858
176 CD 9731910 BLANK ARCHIVE 9731910
177 CABLE 9732080 OPTICAL P4 POWER/COMM 9732080
178 PWR SUPPLY 9732150 UNINTERRUPTIBLE SMART 9732150
179 CABLE 9732187 MICROSCOPE EXTENSION 9732187
180 FLUORO TRACKER 9732222 WIRELESS 9 INCH 9732222
181 TRACKER, 9732222R, WRISS FLUORO REWORK 9732222R
182 FOOTSWITCH 9732245 WITH CABLE USB 9732245
183 FLUORO TRACKER 9732247 WIRELESS 12 9732247
184 TRACKER, 9732247R, WRLESS FLUORO REWORK 9732247R
185 SPLITTER 9732266 4 PORT VGA 9732266
186 PLATE, 9732269, VERIFICATION 9732269
187 KIT 9732306 SURGEON MONITOR 9732306
188 IV POLE, 9732308, 4 HOOK 9732308
189 ANTENNA, 9732313, USB 9732313
190 BAG, 9732314, MOUSE 9732314
191 MOUSE, 9732316, WIRELESS LABELED 9732316
192 MOUSE 9732316R SURGEON LABELED RWK 9732316R
193 WIRELESS MOUSE 9732319XOM KIT 9732319XOM
194 TRANSFORMER, 9732352, ISO 120/250V 9732352
195 KIT 9732446, 9VAC POWER SUPPLY 9732446
196 KIT, 9732549, SURG MON IV POLE 9732549
197 ADAPTER, 9732566, SHORT BED RAIL 9732566
198 DRAPE, 9732571, AXIEM CRANIAL 9732571
199 WRKSTN, 9732585, STLTHSTN INAV II 9732585
200 MONITOR, 9732610, TRIA 9732610
201 MONITOR, 9732611, TREON 9732611
202 BAG 9732708 FOOTSWITCH EA 9732708
203 POWER SUPPLY, 9732714, ASSY 9VAC, 30W 9732714
204 SYS MAN 9732573FR AXIEM PORTABLE 9732745
205 SYSTEM KIT, 9732747, AXIEM PORTABLE, OUS 9732747
206 SYSTEM KIT, 9732749, AXIEM PORTABLE, OUS 9732749
207 AXIEM KIT, 9732750, PORTABLE PRE-BUILD 9732750
208 C-CLAMP, 9733013, REPLACEMENT PART 9733013
209 SUPPORT ARM KIT, 9733142, TREON MONITOR 9733142
210 STEALTHLINK KIT, 9733155, WINDOWS 9733155
211 ADHESIVE PAD, 9733229, H-TRACKER, SINGLE 9733229

Lampiran 5 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

212 SYSTEM 9733320 AxiEM INTEGRATED 4 PORT 9733320
213 AxiEM 9733320R INTEGRATED 4PORT REWORK 9733320R
214 TRANSFORMER 9733361 ISO 100-240VAC 600W 9733361
215 POWER SUPPLY 9733373 UNIVERSAL ENCL ASSY 9733373
216 CD 9733378 ARCHIVE DEMO EXAMS 9733378
217 COMPUTER 9733384 FLAGSTONE 9733384
218 MONITOR 9733386 19INCH FUSION 9733386
219 CABLE 9733400 USB-A TO USB-B 1M 9733400
220 CABLE 9733406 POWER IEC-M IEC-F 0.6M 9733406
221 CABLE 9733408 ASSEMBLY FUSION SPEAKER 9733408
222 PSU 9733437 POLARIS SPECTRA 9733437
223 PSU 9733437R POLARIS SPECTRA RWK 9733437R
224 SCU 9733438 POLARIS 9733438
225 SCU 9733438R POLARIS RWK 9733438R
226 SOFTWARE 9733467 FUSION ENT APP 9733467
227 CART ASSY 9733472 SUB ASSY FUSION EM 9733472
228 MEDIA KIT 9733477 UPGRADE 9733477
229 POWER CORD KIT 9733540 TREON, RETROFIT 9733540
230 SYSTEM 9733560 FUSION EM 9733560
231 CART 9733560XOM FUSION EM SYSTEM 9733560XOM
232 CABLE 9733571 EXT WIDE SURGEON LCD 9733571
233 CABLE 9733572 INT WIDE SURGEON LCD 9733572
234 CABLE 9733575 EXT SCU TO R/A PSU 9733575
235 CABLE 9733577 STAFF LCD 9733577
236 CABLE 9733579 UPS ON/OFF SWITCH 9733579
237 CABLE 9733580 INTERNAL BREAK-OUT BOX 9733580
238 CABLE 9733581 RS422 SCU TO I/O HUB 9733581
239 CABLE 9733582 INT SCU TO PSU 9733582
240 CABLE 9733585 +5VDC TO I/O HUB 9733585
241 MER KIT 9733586 4 CHANNEL AMP 9733586
242 CABLE 9733587 MP3 AUDIO SIGNAL TO AMP 9733587
243 CABLE 9733588 +12VDC AUDIO POWER 9733588
244 CABLE 9733597 EXTERNAL AXIEM PWR/DATA 9733597
245 PCA 9733600 I/O HUB ENCLOSED 9733600
246 MICRO CNTL KIT 9733601 STIMPILOT 9733601
247 CABLE 9733611 +9VAC TO VIDEO SPLITTER 9733611
248 CART 9733616 STAFF 9733616
249 CART 9733617 SURGEON 9733617
250 POWER SUPPLY 9733619 MULTI OUT 350W 9733619
251 CABLE 9733620 COMM NAV-SCOPE INT RACK 9733620
252 LCD STAFF 9733622 15.4IN 1440 X 900 9733622
253 LCD 9733623 SURGEON 24 1920X1200 9733623
254 Cable 9733624 FOOTSWITCH 15FT 9733624

Lampiran 6 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

255 UPS 9733625 800VA 120/240 SELECTABLE 9733625
256 UPS 9733625R 800VA 120/240 SELECTBL RWK 9733625R
257 BATTERY 9733627 LEAD ACID 24V 34W 9733627
258 SPEAKER 9733628 POWERED STEREO 3W 9733628
259 ENCLOSURE 9733645 TOUCHPANEL INTERFACE 9733645
260 OPT KIT 9733653 DBS STIMPILOT FPU ONLY 9733653
261 HANDLE 9733656 LASER CONTROL 9733656
262 MOUSE 9733670 3 BUTTON WHITE 9733670
263 CABLE 9733709 UPS SER RJ45 TO DB9M 1M 9733709
264 DOCKING 9733730 SURGEON MONITOR 9733730
265 CABLE 9733733 AUDIO 3.5mm 3.5mm X 150mm 9733733
266 HANDLE 9733734 RATCHETING QC SM STRGHT 9733734
267 ARM 9733736 TRANSLATION 9733736
268 ARM 9733737 COUNTERBALANCE 9733737
269 YOKES 9733738 MOUNT 9733738
270 DOCKING 9733739 ARMS 9733739
271 COVER 9733740 SURGEON LCD 9733740
272 ARM 9733741 SURG LCD TRANSLATION 9733741
273 ARM 9733742 SURG LCD COUNTERBALANCE 9733742
274 INTERFACE KIT 9733753 STERIS iOR 9733753
275 INTERFACE KIT 9733754 BERCHTOLD iOR 9733754
276 OPTICAL NAV KIT 9733755 iOR 9733755
277 MONITOR KIT 9733765 BM MNT NO TOUCH FIBR 9733765
278 TRAY 9733768 STEALTH DRAWER PROBE 9733768
279 CABLE 9733777 USB 2.0 PNL MNT A-B 3FT 9733777
280 KEYBOARD 9733779 COMPACT 83 KEYS BLACK 9733779
281 PANEL ASM 9733785 I/O 9733785
282 REF KIT 9733804 IOI INT ICT iMRI 9733804
283 CABLE 9733805 USB EXTENSION 9733805
284 SOFTWARE 9733808 DICOM Q/R 9733808
285 MOUNT 9733812 STAFF LCD TILT AND SWIVEL 9733812
286 SPEAKER 9733819 POWERED STEREO 3W LEFT 9733819
287 CABLE 9733821 MOLLER COMBINED 9733821
288 CABLE 9733822 LEICA COMBINED 9733822
289 CABLE 9733823 ZEISS COMBINED 9733823
290 CABLE 9733824 MICROSCOPE INTERNAL 9733824
291 RECEPTACLE 9733826 LASER POINTER 9733826
292 BRACKET 9733828 VIDEO SPLITTER 9733828
293 BRACKET 9733829 PWR CORD RETRACTOR 9733829
294 HANDLE 9733831 TOP DOCKING 9733831
295 KIT 9733832 AXIEM BRACKET 9733832
296 CABLE 9733844 CAN 9VDC POWER 9733844
297 INTF KIT 9733845 MOLLER 20-1000 PTR 9733845

Lampiran 7 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

298 INTF KIT 9733846 MOLLER 20-1000 UPGD 9733846
299 INTF KIT 9733847 MOLLER VM900 PTR ONY 9733847
300 INTF KIT 9733848 MOLLER VM900 HUD 9733848
301 INTF KIT 9733851 ZEISS NC4 HUD 9733851
302 INTF KIT 9733852 ZEISS PENTERO HUD 9733852
303 INTF KIT 9733853 ZEISS VARIO PTR ONY 9733853
304 INTF KT 9733854 ZEISS PENTERO HD UPGD 9733854
305 CABLE 9733855 BATTERY DISCONNECT 9733855
306 CART 9733857 SURGEON LCD ASSEMBLED 9733857
307 CART 9733858 ASSEMBLED STAFF 220V 9733858
308 MAST 9733861 SHORT CAMERA 9733861
309 COMPUTER 9733865 NEXSTONE 9733865
310 TRAY KIT 9733914 STEALTH DRAWER PROBE 9733914
311 STEALTH STATION IOR 9733921 220V 9733921
312 SFTWR KIT 9733933 DICOM SOFTWARE Q/R 9733933
313 SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R 9733933XOM
314 BRKT KIT 9733942 AXIEM CONN HARDWARE 9733942
315 COMPUTER 9733983 NEXSTONE PLANNING STTN 9733983
316 PACKAGE 9733990 SYNERGY SPINE 9733990
317 UPGRADE KIT 9733995 AXIEM ADD ON 9733995
318 MONITOR 9734038 NEXSTONE PLANNING STATIO 9734038
319 PLNG STATION 9734048R STEALTHSTATION 9734048R
320 CART 9734056 STAFF SHRT 100-120V INTL 9734056
321 CABLE 9734058 EXTENSION SCU TO PSU 9734058
322 RACK 9734060 110V 9734060
323 RACK 9734061 220V 9734061
324 NAVIGATION INTERFACE 9734062 110V 9734062
325 NAVIGATION INTERFACE 9734063 220V 9734063
326 SFTWR 9734078 STEALTHMERGE PLNG STN 9734078
327 SFTWR KIT 9734079 SYN SPINE PLNG STN 9734079
328 SFTWR KIT 9734110 STEALTHVIZ WIN32 60DAY 9734110
329 BAG 9734125 SURGEON MOUSE 9734125
330 MAST 9734136 SHORT SP 9734136
331 BOOM MOUNT 9734143 STERIS LA 9734143
332 BOOM MOUNT 9734144 SKYTRON 9734144
333 BOOM MOUNT 9734145 STRYKER 9734145
334 BOOM MOUNT 9734146 BERCHTOLD 9734146
335 CABLE 9734158 RS422 SCU TO I/O HUB EXT 9734158
336 CABLE 9734161 5VDC TO DVI SPLIT/VGA CON 9734161
337 RELAY 9734172 NAVIGATION RELAY 9734172
338 RECEPTACLE 9734183 LASER POINTER SP 9734183
339 CD/DVD DRIVE 9734185 9734185
340 CABLE 9734187 BOB TO SCU EXTENSION 9734187

Lampiran 8 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

341 LCD DESK KIT 9734188 19IN SURG NONTCH 9734188
342 LCD BOOM KIT 9734192 24in SURGEON TCH 9734192
343 LCD BOOM MT 9734192R 24in TCH RWK 9734192R
344 LCD BOOM KIT 9734193 24in SURG NONTCH 9734193
345 BOOM MOUNT 9734201 STERIS LC 9734201
346 CABLE 9734208 GROUND STRAP EQUIP RACK 9734208
347 CABLE 9734231 12VDC TRANSCEIVER POWER 9734231
348 CART 9734232 STAFF SHORT 220V INTL 9734232
349 CABLE 9734233 AxiEM POWER/DATA 9734233
350 INTERLOCK ASSY 9734241 CART 9734241
351 CABLE 9734265 RS422 SCU TO I/O HUB ADAP 9734265
352 AxiEM KIT 9734266 INTERFACE 9734266
353 AxiEM KIT 9734267 ADD-ON 9734267
354 CABLE 9734268 GROUND STRAP NAV INTERFACE 9734268
355 CABLE 9734269 SCU RESET SWITCH 9734269
356 CABLE 9734271 GROUND NAV INT TO LUG 9734271
357 CABLE 9734280 NAV INT POWER HARNESS 9734280
358 RACK ASSEMBLY 9734314 GENERIC 9734314
359 DESK KIT 9734322 NON TOUCH 9734322
360 NAV INTERFACE ASM 9734324 GENERIC 9734324
361 LCD DESK KIT 9734325 24in SURG NONTCH 9734325
362 LCD DESK KIT 9734326 24in SURG TCH 9734326
363 LCD WALL KIT 9734327 24in SURGEON TCH 9734327
364 INTFC 9734329 NAV INTERFACE UNIT ASY 9734329
365 INTFC KIT 9734337 PTR LEICA OH5 9734337
366 UPGRD KIT 9734341 OH5 BRACKET- 9734341
367 MOUNT KIT 9734344 BERCHTOLD BOOM MNT 9734344
368 MOUNT KIT 9734345 STRYKER BOOM MOUNT 9734345
369 MOUNT KIT 9734346 SKYTRON BOOM MOUNT 9734346
370 MOUNT KIT 9734347 STERIS LC BOOM MNT 9734347
371 MOUNT KIT 9734348 STERIS LA BOOM MNT 9734348
372 CMPTR 9734478R ROLLINGSTONE PLNG STN RWK 9734478R
373 REPLACE KIT 9734485 MARKER ZIEHM 3D FD 9734485
374 COMPUTER 9734519 BRIDGESTONE EMBEDDED 9734519
375 COMPUTER 9734519R BRIDGESTONE REWORK 9734519R
376 TRACKER ASM 9734613 ZIEHM 9734613
377 SOFTWARE 9734630 INSTALL WIRELESS MOUSE 9734630
378 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION 9734638
379 PLNG STATION 9734669R RWK 9734669R
380 MOUSE 9734684 WIRELESS 9734684
381 CART 9734685 SURG TOUCH LCD ASSEMBLED 9734685
382 CART 9734685R SURG TOUCH LCD ASSY RWK 9734685R
383 LCD 9734686 SURGEON TOUCH 24 1920x1200 9734686

Lampiran 9 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

384 MOUNT KIT 9734687 DRAEGER BOOM MNT 9734687
385 MOUNT KIT 9734688 MAQUET BOOM MNT 9734688
386 MOUNT KIT 9734689 TRUMPF BOOM MNT 9734689
387 MOUSE KIT 9734691 WIRELESS SURGEON MOUSE 9734691
388 MOUSE KIT 9734691XOM WIRELESS SURGEON 9734691XOM
389 HD DRIVE 9734699 CD/DVD-RW SATA BEIGE 9734699
390 COUNTERWEIGHTS 9734703 KIT BASE WEIGHT 9734703
391 SOFTWARE 9734733 3D FLUORO CALIBRATN 9734733
392 INSTR 9734754 TOUCHSCREEN INSTALL 9734754
393 UPGRADE KIT 9734758 TOUCHSCREEN 9734758
394 LCD 9734768 24IN WUXGA SHLD TCH 9734768
395 LCD 9734768R 24IN WUXGA SHLD TCH 9734768R
396 UPGRADE KIT 9734769 FUSION - FS TO BS 9734769
397 UPGRADE KIT 9734771 FUSION - NS/BS TO RS 9734771
398 UPGRADE KIT 9734808 - NS/BS TO RS 9734808
399 UPGRADE KIT 9734809 - NS/BS TO RS 9734809
400 STYLUS 9734880 HOLDER WHITE 9734880
401 CASE AXIEM 3 FLAT EMITTER 9734890
402 INSTALL CD 9734891 ARGUS UPDATE 9734891
403 CART 9734894 STAFF AXIEM ONLY 110V 9734894
404 CART 9734895 STAFF AXIEM ONLY 220V 9734895
405 KIT 9734896 OPTICAL UPGRADE STD MAST 9734896
406 KIT 9734984 OPTICAL UPGRADE SHORTMAST 9734984
407 LCD KIT 9734985 SHIELDED TOUCH BM MNT 9734985
408 LCD KIT 9734986 SHIELDED DESKTOP 9734986
409 MOUSE KIT 9734989 StealthStation WIRED 9734989
410 MOUSE 9735001 StealthStation WIRED 9735001
411 CMPTR 9735225 ROLLINGSTONE W/ OS 9735225
412 INSTR 9735336 NDI REV 14 SETUP UTILITY 9735336
413 SOFTWARE 9735345 INSTALL MEDIA TOOLS DB 9735345
414 BRACKET 9735356 LEICA MSCOPE TOOLS DB 9735356
415 TRACKER 9735357 ACTV WIRELESS TOOLS DB 9735357
416 COMPUTER 9735416 ZEPPELIN FUSION 9735416
417 PLNG STATION 9735646 SW/STEALTHVIZ 9735646
418 SW APP 9735699 S8 OPERATING SYSTEM 9735699
419 BRACKET 9735833 SUPPORT ARM ACC 9735833
420 SFW 9735908 STEALTH S8 CRANIAL 9735908
421 SFW 9735910 STEALTH S8 DBS 9735910
422 SFW 9735911 STEALTH S8 STEREOTAXY 9735911
423 INST 9730259 TRACKER, ACTIVE WIRELESS 9730259
424 ZEISS PENTERO HARDWARE – PLUS 9731457
425 HARDWARE 9731463 MOELLER 20-1000 PTR 9731463
426 BRACKET ADAPTER 9731464 MOLLER 20-1000 9731464

Lampiran 10 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

427 LED BRACKET 9731460 ZEISS PENTERO 9731460
428 LED BRACKET, 9731634, ZEISS VARIO 9731634
429 INSTALL CD, 9731958, SPINE TOOLS, PLUS 9731958
430 KIT, 9732178, STEALTHLINK 9732178
431 TRK KIT, 9732777, WRLESS, 12IN, 96-9800 9732777
432 SOFTWARE, MICROCAL, PLUS 9732811
433 TRK KIT, 9732829, WRLESS, 9 IN NAVLNK 9732829
434 HW INTERFACE, 9733048, ISOC3D/ORBIC 9733048
435 Tracker, 9733301, Wireless O-arm, Right 9733301
436 Tracker, 9733302, Wireless O-arm, Left 9733302
437 TRACKER KIT, 9733303, O-ARM WIRELESS 9733303
438 CART, FUSION, STANDARD 9733470
439 PROBE 9733880 LINEAR SHARP HC 9733880
440 FRAME 9733881 CRANIAL ACTIVE HC 9733881
441 TRACKER 9733883 LEICA MICROSCOPE 9733883
442 FIGHTER 9733884 SURETRAK2 ACTIVE HC 9733884
443 FIGHTER 9733885 ACTIVE HC 9733885
444 FRAME 9733886 SMALL ACTIVE HC 9733886
445 FRAME 9733887 ORTHO HC 9733887
446 CD 9734862 STEALTHLINK LIBRARY 9734862
447 INSTALL MEDIA 9735379 CRANIAL TOOLS 9735379
448 ACC 961-413 LED BRACKETS 961-413
449 ACC 961-477 NC4 LED BRACKET 961-477
450 HW INTERFACE, 9733048, ISOC3D/ORBIC 9733048R
451 STAND 973550 FUSION COMPACT 9735550
452 CAMERA CART 9735671 STEALTH S8 PREMIUM 9735671
453 SFTWR 9730888 CRANIAL SYSTEM - PLUS 9730888
454 KIT, CRANIAL APPLICATION PLUS 9730896
455 SFTWR 9730897 KIT FUNCTIONAL APP - PLUS 9730897
456 SFTWR 9730901 KIT, LMX TREON - PLUS 9730901
457 SFTWR 9731127 KIT, STEALTHMERGE PLUS 9731127
458 SOFTWARE KIT, 9733243, ELEMENT 9733243
459 SOFTWARE 9733686 SYNERGY SPINE 9733686
460 SOFTWARE 9733760 CRANIAL 9733760
461 SOFTWARE 9733877 STEALTHVIZ LINUX 9733877
462 SOFTWARE 9733878 STEALTHVIZ WIN32 9733878
463 SFTWR KIT 9733913 STEALTHVIZ W/DTI LINUX 9733913
464 SFTWR KIT 9733937 SYNERGY CRANIAL SOF 9733937
465 SFTWR KIT 9733938 MACH CRANIAL 9733938
466 SFTWR KIT 9733979 STEALTHVIZ W/DTI WIN32 9733979
467 APPLICATION 9733986 FRAMELINK 9733986
468 PS KIT 9734066 FRAMELINK 9734066
469 SFTWR KIT 9734067 MCH CRANI PLNG STN 9734067

Lampiran 11 dari 12 Halaman

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.
 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

No. Deskripsi Tipe / Kode

470 TWR KIT 9734068 SYN CRANI PLNG STN 9734068
471 SFTWR KIT 9734080 STEALTHVIZ LINUX MULTI 9734080
472 SFTWR KIT 9734081 STEALTHVIZ WIN32 MULTI 9734081
473 SOFTWARE, 9734107, STEALTHVIZ INT LINUX 9734107
474 SOFTWARE, 9734108, STEALTHVIZ INT WIN32 9734108
475 SFTWR KIT 9734111 StealthViz INT LINUX 9734111
476 SFTWR KIT 9734112 StealthViz INT WIN32 9734112
477 SOFTWARE 9734149 UNIVERSAL ITKR 9734149
478 SOFTWARE 9734150 UNIVERSAL ITHR 9734150
479 SOFTWARE 9734220 MACH POLESTAR 9734220
480 SFTW KIT 9734376 ITHR 9734376
481 SFTW KIT 9734377 ITKR 9734377
482 COMPUTER 9735602 FUSION COMP LOADED 9735602
483 SOFTWARE 9735638 FUSION COMPACT ENT 9735638
484 SFW KIT 9735680 FUSION COMP ENT WITH PG 9735680
485 SW KIT 9735586 STEALTHSTATION CRANIAL 9735586
486 SW KIT 9735587 STEALTH CRANIAL PLNG STN 9735587
487 SFW Kit 9735696 STEALTHCONNECT SYS 9735696
488 ZIEHM RFD TRACKER 9736092
489 ZIEHM RFD TRACKER 9736093
490 ZIEHM RFD TRACKER 9736096
491 ZIEHM RFD TRACKER 9736097
492 ZIEHM RFD TRACKER 9736098
493 ZIEHM RFD TRACKER 9736099
494 ZIEHM RFD TRACKER 9736105
495 TRACKER 9736146 ZEISS KINEVO 9736146
496 Quick reference guide 9736144
497 Cable 9736143
498 Tools Database 9736041
499 CABLE, S8 WIRED KEYBOARD 9736022
500 MOUSE KIT 9732319R SURGEON MOUSE 9732319R

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

Jakarta, 16 November 2020

Lampiran 12 dari 12 Halaman

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.
 Diproduksi: MEDTRONIC NAVIGATION, INC, United States
Untuk MEDTRONIC INC., United States Melalui MEDTRONIC
INTERNATIONAL TRADING PTE. LTD., Singapore
Diimpor: PT. Medtronic Indonesia, Jakarta - Indonesia
KEMENKES RI AKL...

Registration Purpose Only

 StealthStation S8

Marking Label
4 System specifications

System specifications
The specifications listed apply to system operation under typical conditions.

Table 4: StealthStation™ S8 System specifications

Operating temperature 18° to 30°C (64° to 86°F)

Operating pressure 101.3 kPa to 69.7 kPa

Operating altitude -50 m (-164 ft) minimum

3000 m (9842 ft) maximum

Shipping temperature -29° to 60°C (-20° to 140°F)

Storage temperature 15° to 30°C (59° to 86°F)

Input voltage ~100–~230 V

Input frequency 50–60 Hz

Fuse rating 10 A

Maximum power 900 VA

Typical power dissipation 400–600 VA

UPS 5 minutes autonomy

Relative humidity 20% to 80% Non-condensing

Monitor dimensions 389 mm high by 648 mm wide by 63 mm deep (15.3 in high by

25.5 in wide by 2.5 in deep)

Monitor weight 7.5 kg (16.5 lb)

Monitor display Resolution = 2560 x 1440 pixels, 60 Hz

Camera cart footprint 68 cm wide by 69 cm deep (26.9 in wide by 27.1 in deep)

Camera cart weight 75 kg (165 lb)

Main cart footprint 69 cm wide by 52 cm deep (27.3 in wide by 20.4 in deep)

Main cart weight without 113 kg (250 lb)

EM components
System classifications

Main cart weight with EM 118 kg (260 lb)

components and the side-
mount emitter

Main cart weight with EM 125 kg (275 lb)

components, the side-
mount emitter, and the flat
emitter

System classifications
Table 5: General StealthStation™ S8 System classifications

Agency System Rating

FDA Medical Device Class II

21 CFR 882.4560

Electrical Safety Classification Class I, continuous operation with BF applied parts (all applied
IEC 60601-1/UL 60601-1/ parts are of a single function), equipment not suitable for use
CAN/CSA-C22.2 No. 60601-1: 14 in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR or WITH OXYGEN OR NITROUS OXIDE.

IEC 60601-1: 3rd Edition Pollution Degree 2

Overvoltage Category II

Electromagnetic Emissions Compatibility, IEC 60601-1-2 Class A, Group 1

Table 6: Water Ingress Classifications

Component Water Ingress Classification

System (both carts) IPX0 (not protected)

Electromagnetic instrument interface IPX0 (not protected)

Side-mount emitter IPX0 (not protected)

Flat emitter IPX2 (protected against dripping water when tilted up to 15

degrees)

Camera IPX0 (not protected)

Footswitch Equal to or better than IPX6