KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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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.

NOMOR IZIN EDAR A L A T K E S E H A T A N

KEMENKES RI AKL 21603020986

Nama Dagang / Merek : BERCHTOLD OPERON Operating Table Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Kategori Produk : Peralatan Bedah Umum dan Bedah Plastik Sub Kategori : Peralatan Bedah

Jenis Produk : Operating tables and accessories with modification

Tipe / Ukuran : D 760

Kemasan : Unit

Nama Produsen / Pabrikan : BERCHTOLD GMBH & CO. KG., Germany

Melalui STRYKER SINGAPORE PTE. LTD, Singapore Nama Pendaftar : PT. ESA MEDIKA MANDIRI, Banten

Atas dasar lisensi dari : - Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 31 Desember 2022.

2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.

3. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk tersebut, pendaftar bersedia mengembalikan izin edar.

4. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari persetujuan izin edar ini.

5. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau kembali.

Jakarta, 11 Maret 2020

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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

Catatan:

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 21603020986

No. Deskripsi Tipe / Kode

1 Fuse 1744

2 Transformer 65215

3 Printed filtering board 65606

4 Traction Unit 85006

5 Crution roll for Extenstion unit 85026

6 Counter Pull Bar for Extention Unit 85267

7 Castor 85575

8 Castor with STEER 85576

9 Screw, C‘sink, M5X12, DIN 7991 A2 86447

10 Cable set - sensors 86518

11 Power supply 86839

12 Hand pendant 87033

13 Telescope cover D 850 87925

14 Base cover D 850 88113

15 Side panels 89269

16 Side panels 89270

17 Telescope cover D 820, D 760 89360

18 CPU D 820 89384

19 Emergency hand pendant D 820 89426

20 Column Cover 89464

21 CPU D 760 89587

22 CPU D 850 89941

23 Hand Pendant 106815

24 Battery 307166

25 Control board SCANDIA RC K79433T

26 Base table OPERON D 760 inc. seat plate material phenolic, seat plate pad SAF, hand pendant, seat pl

OMY 7600001

27 InstaDrive OY 1000001

28 Levelling adjustment OY 1000002

29 Seat plate long, with kidney elevator OY 1000003

30 Backlight hand pendant OY 1000004

31 Leg plate long version 600 mm OY 1000007

32 Leg plate material carbon fibre OY 1000008

33 Leg plate pad gel OY 1000009

34 Back plate splitting OY 1000010

35 Back plate material carbon fibre OY 1000011

36 Back plate pad gel OY 1000012

37 Head rest adjustment double jointed OY 1000013

38 Head rest material carbon fibre OY 1000014

Lampiran 1 dari 6 Halaman

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Catatan:

39 Head rest pad gel OY 1000015

40 Split leg plates, long OY 1000016

41 Split leg plate, material carbon fibre OY 1000017

42 Cutout for Gynae and Uro, back plate (only in conjunction with standard phenolic, one piece, not in

OY 1000019

43 Radial setting clamp OZ 1001041

44 Radial setting clamp, (EU) OZ 1001071

45 Radial setting clamp, (US) OZ 1001075

46 Anaesthesia screen with radial setting OZ 1001101

47 Elongation bar for anaesthesia screen OZ 1001101 OZ 1001121

48 Horseshoe shaped head rest OZ 1001351

49 Wrist support for horseshoe shaped head rest OZ 1001351 OZ 1001352

50 ENT head rest, adjustable over 2 joints OZ 1001400

51 Head rest multi adjustable, 4-joints, incl. pad OZ 1001410

52 Extension for upper arm (Weinberger) OZ 1001450

53 Leg strap, 2-piece OZ 1001720

54 Wristlet Strap with Clamps OZ 1001760

55 Infusion stand with radial setting clamp OZ 1002001

56 Restraint strap for leg holder OZ 1203350 OZ 1002520

57 Arthroscopy leg holder w/o clamp OZ 1002540

58 Body restraint strap OZ 1002650

59 Laminectomy frame OZ 1002850

60 Kidney elevator plate OZ 1002950

61 Tibia support / knee rest, w/o clamp OZ 1003310

62 Knee-elbow positioning device D series, (EU) OZ 1005200

63 Quick clamp, flat blade, (EU) OZ 1006104

64 Mayo instrument table, w/o clamp OZ 1101600

65 Pad, flat shape, for armboard OZ 1201850 OZ 1201811

66 Restraint strap for armboards OZ 1201850, OZ 1251804, OZ 1252104, OZ 1251900 and OZ 1251875

OZ 1201830

67 Armboard, height adjustable, (EU) OZ 1201850

68 Knee crutch Goepel, w/o clamp OZ 1203350

69 Knee crutches Goepel, type XL, w/o clamp, pair OZ 1204000 70 Standard armboard, adjusted with a trigger, (EU) OZ 1204104

71 Accessory stand, (US) OZ 1205075

72 Pad, concave shape, for armboards OZ 1251875, OZ 1251804, OZ 1252104

OZ 1251800

73 Arm support with ball joint adjustment, w/o pad, (EU) OZ 1251804 74 Pad, flat shape, for armboards OZ 1251875, OZ 1251804, OZ

1252104

OZ 1251810

75 Arm support with ball joint adjustment, without pad, (US) OZ 1251875 76 Flexible armboard with one-hands operation, dual ball joint, universal

side rail socket

OZ 1251900

77 Hand/arm table, rectangular, incl. clamps, (EU) OZ 1252204

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Catatan:

78 Hand/arm table, carbon fibre, incl. clamps, (EU) OZ 1252304 79 Hand/arm table, carbon fibre, incl. clamps, (US) OZ 1252375 80 Safe guards, lateral foldable supports, pair, (EU) OZ 1252404

81 Safe guards pad OZ 1252450

82 Mains connection cable EU OZ 1305004

83 Mains connection cable UK OZ 1305024

84 Mains connection cable AUS OZ 1305034

85 Mains connection cable US, with hospital grade plug OZ 1305075

86 Shoulder support, w/o clamp, pair OZ 1501100

87 Shoulder support, pad articulation, w/o clamp, pair OZ 1501200

88 DORO Neuro headrest system aluminium OZ 1502500

89 DORO Horseshoe headrest aluminum, adult OZ 1502510

90 DORO Horseshoe headrest aluminum, pediatric OZ 1502520

91 DORO Crossbar adaptor OZ 1502540

92 Body restraint strap, wide model, additionally padded OZ 1502650

93 Leg plate for extension unit, pair OZ 1504101

94 Leg support for extension unit OZ 1504200

95 Traction stirrup clamp for extension unit OZ 1504300

96 DORO Horseshoe headrest, radiolucent, adult OZ 1505010

97 DORO Radiolucent neuro headrest system OZ 1505050

98 DORO Reusable skull pins stainless steel, 3 pins, adult OZ 1507500 99 DORO Reusable skull pins stainless steel, pediatric, 3 pins OZ 1507510 100 Adapter for specialist head sections and neuro-surgical equipment

DORO and Mayfield for D-Series, St

OZ 1509900

101 Adapter for specialist head sections and neuro-surgical equipment DORO and Mayfield, universal side

OZ 1509901

102 Access code for external control B710, incl. servicing software level I OZ 1603060 103 Lateral brace, circular for pubis positioning OZ 1609104 104 Extension unit carbon fibre, OPERON D 750-D 850, (EU) OZ 1703004

105 Extension unit, OPERON D 750-D 850, (EU) OZ 1704004

106 Extension unit, OPERON D 750-D 850, (US) OZ 1704075

107 Leg section for D 750 and D 850, EU side-rails OZ 1704104 108 Leg section for D 750/D820/D850, with EU side-rails, with Phenolic

top

OZ 1704504

109 Adapter for extension unit, OPERON D 750-D 850 OZ 1705060 110 TUR module for patient positioning, OPERON D 750-D 850, (EU) OZ 1705604 111 Short Leg Section 20in for OPERON D850, EU-Version OZ 1705704 112 Leg plate for OPERON D 750-D 850, EU-rails, Phenolic, incl. pads,

length 510 mm

OZ 1705804

113 Leg plate for OPERON D 750-D 850, US-rails, Phenolic, incl. pads, length 510 mm

OZ 1705875

114 CUSHION F.KNEE HOLDER OZ 1002530 OZ 2060000

115 Torso section mattress with cutout, size 75 x 100 cm OZ 2200150 116 Patient transfer board, long and wide version, 1,800 x 520 mm OZ 3000100

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Catatan:

117 Universal prepper, w/o clamp OZ 3000190

118 Universal rail clamp, fits all posts, square, round and rectangular, (US)

OZ 3000475

119 Accessory stand, providing storage for stirrups, split leg, leg section OZ 3100204

120 Pads for basic stirrups OZ 3200101

121 Arm protection shield sliding below table pad, incl. pad OZ 3200110 122 LPS armboard, ideal for lateral, prone and seated positions, w/o

clamp, incl. pad and strap

OZ 3200200

123 Beach chair attachment for OPERON D 820, D 850 incl. EU rail and head rest assembly

OZ 3300204

124 Beach chair cart OZ 3300210

125 Chin strap reusable beach chair OZ 3300220

126 Beach chair attachment for OPERON D 7xx incl. EU rail and head rest assembly

OZ 3300304

127 Spine frame system for OR table, fixations included OZ 3500100 128 Spine Frame replacement pads, set of 2 pc., left and right OZ 3500101 129 Spine frame crank for spine frame system OZ 3500100 OZ 3500110 130 Spine Frame disposable covers, set of 6 pc., covers for frame, head

and arms

OZ 3500120

131 Width extender, incl. clamp, 500 x 100 mm, (EU) OZ 3700104 132 Width extender, incl. clamp, 280 x 200 mm, (EU) OZ 3700204 133 Armboard, bariatric, with height adjustment and clamp, (EU) OZ 3700304 134 Junior stirrups (7 to 11 years), w/o clamps, pair OZ 3800100 135 Pediatric stirrups (3 to 6 years), w/o clamps, pair OZ 3800110 136 Children basic stirrups (7 to 11 years), w/o clamps, pair OZ 3800140

137 Armboard, multifunctional OZ 7500475

138 Fixing clamp, flat blade, (EU) OZ 7500804

139 Fixing clamp, flat blade, (US) OZ 7500875

140 Body restraint strap, padded OZ 7500975

141 Lateral support, individual, for lateral positioning set OZ 7501075

142 Knee crutches, Goepel, pair OZ 7501575

143 Premium leg stirrups, pair OZ 7501775

144 Attachment straps for drainage bags, (EU) OZ 7501804

145 Side rail extender, (US) OZ 7503975

146 Instrument surface OZ 7504075

147 Armboard, trigger, (US) OZ 7504175

148 standard set of pads for OR table OPERON B 810 OZ 7507875 149 comfort set of gel pads for OR table OPERON B 810 OZ 7508075

150 X-ray cassette tray for OPERON B810 OZ 7508275

151 Pad for Standard Trigger Armboard OZ 1204104 / OZ 7504175 pair OZ 7509375 152 Foot control compatible with OPERON B 710/B 810, 3 functions for

height/Trendelenburg/ lateral tilt

OZ 7510275

153 Pad for leg holder (Set of 12 pcs.) OZ 7512075

154 Replacement pad for universal hand table OZ 7515775 OZ 7515275

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Catatan:

155 Neuro adapter, (US) OZ 7515575

156 Quick clamp, flat blade, (US) OZ 7516175

157 Clamp multi-purpose OZ 7516275

158 pair of leg plates for OPERON B810 OZ 7517175

159 Pad, for narrow head rest OZ 7517375 OZ 7517275

160 Neuro adapter, (EU) OZ 7517475

161 Shoulder chair, integrated, for OPERON B 810 OZ 7517975 162 Gel Pad, OPERON D 750 /D820 / D 850, 4 PC Set OZ 7518075

163 X-ray cassette, OPERON D 750-D 850 OZ 7518475

164 Foot control, OPERON D 750-D 850 OZ 7518675

165 Pad, Vascular Arm Board OZ 7518775

166 Leg stirrup, bariatric, pair OZ 7518975

167 Body restraint strap, bariatric OZ 7519075

168 Beach chair attachment for OPERON D 820, D 850 incl. US rail and head rest assembly

OZ 7519475

169 TUR Plate Assembly for OPERON D850/D750 provides patient support for extrem reverse Trendelenburg

OZ 7519675

170 Perineal filler, OPERON D 750-D 850, (small) OZ 7519975

171 Kidney support, OPERON D 750-D 850 OZ 7520075

172 Imaging extension, short, OPERON D 750-D 850, (CFK) OZ 7520175 173 Pediatric table, OPERON D 750-D 850, (EU, CFK) OZ 7520304 174 Pediatric table, OPERON D 750-D 850, (US, CFK) OZ 7520375

175 Nissen straps, pair, USA OZ 7520575

176 Pad, 36in Imaging Ext., D850 Prem, 2-3/8in OZ 7520775

177 Pad (1.117 mm), long, for carbon fiber imaging extension OZ 7521275

OZ 7520975

178 Imaging extension, long, OPERON D 750-D 850, (CFK) OZ 7521275 179 Split leg plate (leg plate material phenolic, leg plate pad SAF, EU) OZ 7521304 180 Split leg plate (leg plate material phenolic, leg plate pad SAF, US) OZ 7521375 181 Pad for the left leg plate of the Integrated Split Leg Assembly for

OPERON D850 / D750

OZ 7521675

182 Pad for the right leg plate of the Integrated Split Leg Assembly for OPERON D850 / D750

OZ 7521775

183 Pad, pair, for footboard OZ 7521875 OZ 7522075

184 Leg transfer plate, OPERON D 750-D 850 OZ 7522475

185 Imaging extension clamp w/rail (EU) OZ 7522504

186 Filler piece for seat plate cutout, OPERON D 750-D 850, (big) OZ 7522675 187 Leg transfer, sling style, OPERON D 750-D 850 OZ 7522975 188 Beach chair attachment for OPERON D 7xx incl. US rail and head

rest assembly

OZ 7523075

189 Foot board / foot extension OZ 7523275

190 Foam Pad Head B 810 2-3/8in OZ 7525475

191 Leg transfer board, adjustable, OPERON D 750-D 850 OZ 7529075

192 Shoulder support, TrenStop, pair OZ 7531875

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Catatan:

193 Accessory stand for leg stirrups, single and split leg plates OZ 7532175

194 TABLEGARD Mattress heated for Torso length OZ 7535275

195 Lateral positioning set OZ 7537375

196 Gel head ring, for adults OZ 7538575

197 Gel head ring, for adolescents/children OZ 7538675

198 Gel head ring open OZ 7538775

199 Gel heel cushion OZ 7538875

200 Gel heel cushion OZ 7538975

201 Gel universal application OZ 7539075

202 Gel ulnar nerve cushion OZ 7539175

203 Gel half roll, 330 x 127 x 102 (mm, L x B x H) OZ 7539275 204 Gel half roll, 432 x 127 x 102 (mm, L x B x H) OZ 7539375 205 Gel half roll, 533 x 127 x 102 (mm, L x B x H) OZ 7539475 206 Gel half roll, 533 x 178 x 152 (mm, L x B x H) OZ 7539575 207 Gel positioning support, 254 x 127 x 51 (mm, L x B x H) OZ 7539675 208 Gel positioning support, 381 x 127 x 57 (mm, L x B x H) OZ 7539775 209 Gel arm support cushion, 406 x 146 x 57 (mm, L x B x H) OZ 7539875 210 Kneeboard, (EU), for Support roll kneeboard combination, OPERON

D 750-D 850

OZ 7540004

211 Gel arm support cushion, 508 x 146 x 57 (mm, L x B x H) OZ 7540175 212 Gel Neonatal head rest L x W x H (mm): 83 x 32 x19 OZ 7546375 213 Gel Prone head rest L x W x H (mm): 280 x 230 x 150 OZ 7546475 214 Replacement pad set for bariatric leg stirrups OZ 7555575 215 Leg plate Standard (Leg plate material phenolic, leg plate pad SAF,

short version 510 mm)

OZY 1000001

216 Back plate Standard (Back plate material phenolic, back plate pad SAF, one piece)

OZY 1000002

217 Head rest Standard (Head rest material phenolic, head rest pad SAF)

OZY 1000003

218 Split leg plate OZY 1000004

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

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