KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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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:

- 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.

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 A L A T K E S E H A T A N

KEMENKES RI AKL 20502210372

Nama Dagang / Merek :

PHILIPS Intellivue Patient Monitor

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B Kategori Produk : Peralatan Kardiologi

Sub Kategori : Peralatan Kardiologi Pemantauan

Jenis Produk : Cardiac monitor (including cardiotachometer and rate alarm).

Tipe / Ukuran : MX 700

Kemasan : Unit

Nama Produsen / Pabrikan : PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH., Germany Nama Pendaftar : PT. PHILIPS INDONESIA COMMERCIAL, DKI Jakarta

Atas dasar lisensi dari : - Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 05 Februari 2023.

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 dan perubahan Nama Pemberi Penunjukkan dari nomor pendaftaran AKL 20502210372 tanggal 14 Juli 2016. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku lagi.

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, 11 April 2019

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20502210372

No. Deskripsi Tipe / Kode

1 3-Electrode Cable Set M1669A

2 3-Electrode Cable Set, OR 989803170171

3 5-Electrode Cable Set M1668A

4 5-Electrode Cable Set, OR 989803170181

5 6-Electrode Cable Set M1667A

6 10-Electrode Cable set (5+5) M1663A

7 10-Electrode Cable set (6+4) M1665A

8 OR Grabber shielded 1.0 m M1675A M1678A

9 ICU Grabber shielded 1.0 m M1671A M1672A

10 ICU snap shielded 1.0 m M1673A M1674A

11 ICU Clip non-shielded 0.45 m M1622A --

12 ICU Clip non-shielded 0.7 m M1624A M1626A

13 Telemetry Grabber 0.85 m 989803151971

989803151981

14 Telemetry Snap 989803151991

989803152001

15 ICU Grabber shielded 1.0 m 989803173121

989803174201

16 ICU Grabber shielded 0.84 m 989803173141 -

17 OR Grabber shielded 1.0 m/1.6 m M1973A M1974A

18 ICU Grabber shielded 1.0 m/1.6 m M1968A M1971A

19 ICU Snap shielded 1.0 m/1.6 m M1644A M1645A

20 ICU Miniclip non-shielded 0.7 m/1.3 m M1647A M1648A

21 ICU DIN-to-tab adapter 1.0 m/1.6 m 989803192181

989803192191

22 Telemetry Grabber 0.85 m 989803152051

989803152061

23 Telemetry Snap 0.85 m 989803152071

989803152081

24 ICU Grabber shielded 1.0 m 989803173131

989803174211

25 ICU Grabber shielded 0.85 m 989803173151 -

26 OR Grabber 1.0 m/1.6 m M1684A M1685A

27 ICU Grabber 1.0 m/1.6 m M1680A M1681A

28 ICU Snap 1.0 m/1.6 m M1682A M1683A

29 ICU DIN-to-tab adapter 1.0 m/1.6 m 989803192221

989803192231

30 Telemetry Grabber 0.85 m 989803152131

989803152141

31 Telemetry Snap 0.85 m 989803152151

989803152161

Lampiran 1 dari 9 Halaman

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

32 ICU Grabber, shielded 1.0 m 989803197511

989803197521

33 ICU Grabber, chest, shielded 1.0 m M1976A M1978A

34 ICU Snap, chest, shielded 1.0 m M1602A M1604A

35 OR Grabber, chest, shielded 1.0 m M1979A M1984A

36 ICU DIN-to-tab adapter 1.0 m 989803192201

989803192211

37 ICU Grabber, chest, shielded 1.0 m 989803192141

989803192151

38 ICU Grabber, chest, shielded 1.0 m M1532A M1533A

39 ICU Snap, chest, shielded 1.0 m M1537A M1538A

40 OR Grabber, chest, shielded 1.0 m M1557A M1558A

41 ICU DIN-to-tab adapter 1.0 m 989803192241

989803192251

42 3-lead Grabber, ICU 1.0 m 989803143181

989803143171

43 5-lead Grabber, ICU 1.0 m 989803143201

989803143191 44 Pack of five single wires, radio-translucent, 0.9 m M1649A

45 Set combiner 3-electrode M1501A

46 Set combiner 5-electrode M1502A

47 Set organizer for shielded leadsets - grabber and snap 3-electrode M1503A 48 Set organizer for shielded leadsets - grabber and snap 4-electrode M1664A 49 Set organizer for shielded leadsets - grabber and snap 5-electrode M1504A 50 Set organizer for shielded leadsets - grabber and snap 6-electrode M1679A 51 Set organizer for non-shielded lead sets - miniclip 3-electrode M1636A 52 Set organizer for non-shielded lead sets - miniclip 5-electrode M1638A

53 Bedsheet clip M1509A

54 Replacement red cover for trunk cable (for 5-electrode cable sets) 989808148861

55 Tab/Snap adapters, 10 pieces 989803193821

56 Adult (Thigh) 42 to 54 cm M1576A

57 Large Adult 34 to 43 cm M1575A

58 Large Adult XL 34 to 43 cm M1575XL

59 Adult 27 to 35 cm M1574A

60 Adult XL 27 to 35 cm M1574XL

61 Small Adult 20.5 to 28 cm M1573A

62 Small Adult XL 20.5 to 28 cm M1573XL

63 Pediatric 14 to 21.5 cm M1572A

64 Infant 10 to 15 cm M1571A

65 Infant, pediatric, small adult, adult M1577A

66 Small adult, adult, large adult, thigh M1578A

67 Infant, pediatric, small adult, adult, large adult, thigh M1579A

68 Small adult XL, adult XL, large adult XL M1579XL

69 Adult Thigh 44 - 56 cm M4559B (M4559B5)

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

70 Large Adult X-Long 35 - 45 cm M4558B (M4558B5)

71 Large Adult 35 - 45 cm M4557B (M4557B5)

72 Adult X-Long 27.5 - 36 cm M4556B (M4556B5)

73 Adult 27.5 - 36 cm M4555B (M4555B5)

74 Small Adult 20.5 - 28.5 cm M4554B (M4554B5)

75 Pediatric 14 - 21.5 cm M4553B (M4553B5)

76 Infant 10 - 15 cm M4552B (M4552B5)

77 Assortment pack of one small adult, one adult, one large adult and one thigh cuff

864288

78 Assortment pack of one infant, one pediatric, one small adult and one adult cuff

864289

79 Assortment pack of one infant, one pediatric, one small adult, one adult, one large adult andone thigh cuff

864290

80 Assortment pack of one small adult, one adult, one adult X-long, one large adult, one largeadult X-long and one thigh cuff

864291

81 Adult Thigh 42.0 - 54.0 cm 989803183371

82 Large Adult 34.0 - 43.0 cm 989803183361

83 Large Adult X-Long 27.0 - 35.0 cm 989803183351

84 Adult 27.0 - 35.0 cm 989803183341

85 Small Adult 20.5 - 28.0 cm 989803183331

86 Pediatric 14.0 - 21.5 cm 989803183321

87 Infant 10.0 - 15.0 cm 989803183311

88 Adult (Thigh) 44 - 56 cm M4579B

89 Large Adult X-Long 35 - 45 cm M4578B

90 Large Adult 35 - 45 cm M4577B

91 Adult X-Long 27.5 - 36 cm M4576B

92 Adult 27.5 - 36 cm M4575B

93 Small Adult 20.5 - 28.5 cm M4574B

94 Pediatric 14.0 - 21.5 cm M4573B

95 Infant 10 - 15 cm M4572B

96 Large Adult 35.0 - 45.0 cm 989803182321

97 Adult X-Long 27.5 - 36.0 cm 989803182311

98 Adult 27.5 - 36.0 cm 989803182301

99 Small Adult 20.5 - 28.5 cm 989803182291

100 Pediatric 14.0 - 21.5 cm 989803182281

101 Large Adult 34.0 - 43.0 cm 989803160861

102 Adult XL 27.0 - 35.0 cm 989803160851

103 Adult 27.0 - 35.0 cm 989803160841

104 Small Adult 20.5 - 28.0 cm 989803160831

105 Pediatric 14.0 - 21.5 cm 989803160821

106 Infant 10.0 - 15.0 cm 989803160811

107 Size 1 3.1 to 5.7 cm M1866A/B

108 Size 2 4.3 to 8.0 cm M1868A/B

109 Size 3 5.8 to 10.9 cm M1870A/B

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

110 Size 4 7.1 to 13.1 cm M1872A/B

111 Size 5 (Infant) 10 to 15 cm M1873B

112 Size 1 3.1 to 5.7 cm M1866S

113 Size 2 4.3 to 8.0 cm M1868S

114 Size 3 5.8 to 10.9 cm M1870S

115 Size 4 7.1 to 13.1 cm M1872S

116 Size 5 (Infant) 10 to 15 cm M1873S

117 Standard, Single Patient: 5 x M1866B, 10 x M1868B, 20 x M1870B, 10 x M1872B, and 5 x M1873B

989803167541

118 Soft, Single Patient: 5 x M1866S, 10 x M1868S, 20 x M1870S, 10 x M1872S, 5 x M1873S

989803167551

119 Reusable pressure transducer 5 ?V/V/mmHg sensitivity CPJ840J6 120 Sterile disposable pressure domes for CPJ840J6 (pack of 50) CPJ84022

121 Transducer holder for CPJ840J6 (pack of 4) CPJ84046

122 IV pole mount for CPJ840J6 CPJ84447

123 Monitoring Line Set CPJ84026

124 PiCCO monitoring kit, 30 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A

PV8103

125 PiCCO monitoring kit, 150 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A

PV8115

126 PiCCO monitoring kit, 150 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A and central venous pressure line

PV8115CVP

127 PULSION Pressure Interface Cable for disposable pressure transducer

PMK 206

128 Adult sensor (2 m cable), for patients over 50 kg.Any finger, except thumb.

M1191A/B

129 M1191A/B with longer cable (3 m) M1191AL/BL

130 Small adult, pediatric sensor (1.5 m cable) forpatients between 15 kg and 50 kg. Any fingerexcept thumb.

M1192A

131 Neonatal sensor (1.5 m cable) for patientsbetween 1 kg and 4 kg.

Hand or foot.

M1193A

132 Ear sensor (1.5 m cable) for patients over 40 kg. M1194A 133 Infant sensor (1.5 m cable) for patients between4 kg and 15 kg. Any

finger except thumb.

M1195A

134 Adult clip sensor (3 m cable) for patients over40 kg. Any finger except thumb.

M1196A

135 Adult clip sensor (2 m cable) for patients over40 kg. Any finger except thumb.

M1196S

136 Adult sensor (0.45 m cable), for patients over50 kg. Any finger, except thumb.

M1191T

137 Small adult, pediatric sensor (0.45 m cable) for cablepatients between 15 kg and 50 kg. Any fingerexcept thumb.

M1192T

138 Neonatal sensor (0.9 m cable) for patientsbetween 1 kg and 4 kg.

Hand or foot.

M1193T

139 Adult clip sensor (0.9 m cable) for patients over40 kg. Any finger except thumb.

M1196T

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

140 Identical to OxiMax MAXN M1901B1

141 Identical to OxiMax MAXI M1902B1

142 Identical to OxiMax MAXP M1903B1

143 Identical to OxiMax MAXA M1904B1

144 Adult/Pediatric finger sensor, 0.45 m cable(patient size > 20 kg) M1131A 145 Infant finger or toe sensor, 0.9 m cable(patient size 3 - 10 kg) M1132A 146 Adult/Infant/Neonatal, 0.9 m cableFoot or hand for neonates < 3

kgBig toe or thumb for patients between 10 kgand 20 kgAny finger except thumb for patients > 40 kg

M1133A

147 Adhesive-free, Adult/Infant/Neonatal, 0.9 mcableFoot or hand for neonates < 3 kgBig toe or thumb for patients between 10 kgand 20 kgAny finger except thumb for patients > 40 kg

M1134A

148 Adult finger sensor (patient size > 30 kg) OxiMax MAX-A

149 OxiMax MAX-A with long cable OxiMax MAX-AL

150 Pediatric foot/hand sensor (patient size 10 - 50 kg) OxiMax MAX-P 151 Infant foot/hand sensor (patient size 3 - 20 kg) OxiMax MAX-I 152 Adult finger or neonatal foot/hand sensor (patient size >40kg or<3kg) OxiMax MAX-N

153 Forehead sensor (patient size ? 10 kg) MAXFAST

154 Adult nasal sensor (patient size > 50 kg) OxiMax MAXR 155 Adult SoftCare sensor (patient size > 40 kg) OxiMax SC-A 156 Neonatal SoftCare sensor (patient size 1.5 - 5 kg OxiMax SCNEO-I 157 Pre-term infant SoftCare sensor (patient size <1.5kg) OxiMax SC-PR-I 158 Adult sensor (patient size > 30 kg) Oxisensor II D-25 159 Pediatric sensor (patient size 10 - 50 kg) Oxisensor II D-20 160 Infant sensor (patient size 3 - 20 kg) Oxisensor II I-20 161 Neonatal sensor (patient size < 3 kg or > 40 kg) Oxisensor II N-25

162 See OxiMax MAXA Oxicliq A

163 See OxiMax MAXP Oxicliq P

164 See OxiMax MAXI Oxicliq I

165 See OxiMax MAXN Oxicliq N

166 Adult/Neonatal SpO2 Sensor Oxiband OXI-A/N

167 Pediatric-Infant Sensor Oxiband OXI-P/I

168 Adult finger clip sensor (patient size > 40 kg) Durasensor DS100A-1

169 Y-sensor Dura-Y D-YS

170 Extension cable (2 m) M1941A

171 Adapter cable (1.1 m cable) M1943A

172 Adapter cable (3 m cable) M1943AL

173 OxiMax adapter cable (3 m cable) M1943NL

174 Adapter Cable for Oxicliq sensors OC-3

175 Adult Finger Sensor (> 30 kg) LNOP DCI

176 Pediatric Finger Sensor (10 - 50 kg) LNOP DCIP

177 Multi-Site Sensor (> 1 kg) LNOP YI

178 Ear Sensor (> 30 kg) LNOP TC-I

179 Adult Finger Sensor (> 30 kg) LNCS DCI

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

180 Pediatric Finger Sensor (10 - 50 kg) LNCS DCIP

181 Multi-Site Sensor (> 1kg) LNCS YI

182 Ear Sensor (> 30 kg) LNCS TC-I

183 Adult Sensor (> 30 kg) LNOP Adt

184 Adult Sensor (> 30 kg) LNOP Adtx

185 Pediatric Sensor (10 - 50 kg) LNOP Pdt

186 Pediatric Sensor (10 - 50 kg) LNOP Pdtx

187 Infant Toe Sensor (3 - 20 kg) LNOP Inf-L

188 Neonatal Sensor (< 3 kg) or Adult adhesive Sensor (> 40 kg) LNOP Neo-L 189 Neonatal Pre-Term Sensitive Skin Sensors (< 1 kg) LNOP NeoPt-L 190 Adult Finger Sensor, 18 inch/45 cm (> 30 kg) LNCS Adtx 191 Adult Finger Sensor, 3 feet/90 cm (> 30 kg) LNCS Adtx-3 192 Pediatric Finger Sensor, 18 inch/45 cm (10 - 50 kg) LNCS Pdtx 193 Pediatric Finger Sensor, 3 feet/90 cm (10 - 50 kg) LNCS Pdtx-3 194 Infant Toe Sensor, 18 inch/45 cm (3 - 20 kg) LNCS Inf 195 Infant Toe Sensor, 3 feet/90 cm (3 - 20 kg) LNCS Inf-3 196 Neonatal Foot Sensor, 18 inch/45 cm (< 3 kg) or Adult Finger Sensor

18 inch/45 cm (> 40 kg)

LNCS Neo

197 Neonatal Foot Sensor, 3 feet/90 cm (< 3 kg) or Adult Finger Sensor, 3 feet/90 cm (> 40 kg)

LNCS Neo-3

198 Neonatal pre-term sensitive skin Sensor 18 inch/45 cm (< 1 kg) LNCS NeoPt 199 Neonatal pre-term sensitive skin Sensor 3 feet/90 cm (< 1 kg) LNCS NeoPt-3 200 LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo

LNOP Sensors

LNOP MP12 451261000761

201 LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS Sensors

LNOP MP10 989803148221

202 General purpose probe 21075A / 989803203561

203 Small flexible vinyl probe (Infant/Pediatric) 21076A / 989803203571

204 Attachable surface probe 21078A / 989803203581

205 General purpose probe M1837A / 989803203601

206 Skin probe 21091A / 989803203621

207 Esophageal/Stethoscope Probe (French 12) 21093A / 989803203631 208 Esophageal/Stethoscope Probe (French 18) 21094A / 989803203641 209 Esophageal/Stethoscope Probe (French 24) 21095A / 989803203651

210 Esophageal/Rectal Probe (French 12) 21090A / 989803203611

211 Foley Catheter Probe (12 French) M2255A / 989803203661

212 Foley Catheter Probe (16 French) 21096A / 989803203671

213 Foley Catheter Probe (18 French) 21097A / 989803203681

214 Adapter cable 1.5 m 21082B / 989803203711

215 Adapter cable 3.0 m 21082A / 989803203701

216 Temperature probe 989803180831

217 Disposable probe cover with CE marking (22 boxes each containing 96 covers)

989803179611

218 Disposable probe cover (22 boxes each containing 96 covers) 989803179381

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

219 Cable RJ45 1.5m M8081-61001

220 Cable RJ45 3 m M8081-61002

221 Cable MP5 (connecting base station with the monitor) 453564373311

222 Accessories Set of ice buckets 14455A

223 Accessories Remote handswitch 15244A

224 PiCCO inline temperature probe Latex free M1646A

225 C.O. Interface Cables 2.7 meter cable M1642A

226 C.O. Interface Cables 2.4 m + 2.4 m cable M1643A

227 Right heart catheter for thermodilution (from Edwards Lifesciences) 831HF75 228 Edwards CO-Set+ (only with 23001A/B) contact Edwards

Lifesciences for information

229 Injectate Probes 2.4 m injectate temp. probe (reusable) 23001A 230 Injectate Probes 0.5 m injectate temp. probe (reusable) 23001B

231 Injectate Probes Ice bath temp. probe 23002A

232 C.O. Interface Cables 2.4 m + 2.4 m cable M1643A

233 PULSION Pressure Transducer Kits (pressure line available in various lengths) Contact PULSION for information

234 Pressure Interface Cable for disposable pressure transducer PULSION PMK 206

235 CO2 Sensor M2501A

236 Adult/Pediatric Airway Adapter (reusable) M2513A

237 Infant Airway Adapter (reusable) M2516A

238 Adult Airway Adapter (single-patient use) M2533A

239 Infant Airway Adapter (single-patient use) M2536A

240 CO2 Sensor M2741A

241 Gas Exhaust Tubing M1015-40001

242 Airway Adapter Set, ET > 4.0 mm M2768A

243 Airway Adapter Set, ET ? 4.0 mm 989803144531

244 Airway Adapter Set H, ET > 4.0 mm M2772A

245 Airway Adapter Set H, ET ? 4.0 mm M2773A

246 Straight Sample Line M2776A

247 Straight Sample Line H M2777A

248 Gas Exhaust Tubing M1015-40001

249 Adult/Pediatric Flow Sensor M2785A

250 Neonatal Flow Sensor M2786A

251 Adult/Pediatric CO2/Flow Sensor M2781A

252 Neonatal CO2/Flow Sensor M2782A

253 Pediatric CO2/Flow Sensor M2783A

254 tcpO2/CO2 transducer M1918A

255 Accessory Kit for M1918A (O-ring remover, absorbent paper, electrolyte solution, 12 replacement membranes)

15209-60010

256 Application Kit for M1918A (4x25 disposable fixation rings, contact fluid)

15209-60020

257 tcpO2/CO2 transducer M1918B1

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

258 Accessory Kit for M1918B (10 replacement membranes, electrolyte solution)

9898031519511

259 Application Kit for M1918B (4x25 disposable fixation rings, contact fluid)

9898031519611

260 Calibration gas - 6 gas bottles 15210-60010

261 Calibration gas - 6 gas bottles (Europe and Japan only) 15210-64010

262 Replacement tubing (5 tubes) M2205A

263 Calibration unit 15210B

264 Radiometer TCC3 calibration unit (available from Radiometer) n/a

265 Elbow Airway Adapter (single-patient use) 13902A

266 Straight Airway Adapter (single-patient use) M1612A

267 Gas Exhaust Return Line (multi-patient use) M1655B

268 Gas Exhaust Return Filter (single-patient use) M1656B

269 Water trap (multi-patient use) 989803191081

270 Gas Sample Tube (2.6 m) (single patient use) M1658A

271 2 Channel Trunk Cable 2.7 m M2268A

272 4 Channel Trunk Cable 2.7 m 989803180541

273 Reusable 80-cm-long 5-lead cables with 10 mm silver/silverchloride lead-wired cup electrodes (Adult)

M1931A

274 Reusable 80-cm-long 9-lead cables with 10 mm silver/silverchloride lead-wired cup electrodes (Adult)

989803180561

275 Reusable 80 cm 5-lead cables with 6 mm silver/silverchloride lead- wired cup electrodes (Pediatric/Neonatal)

M1932A

276 Reusable 80 cm 9-lead cables with 6 mm silver/silverchloride lead- wired cup electrodes (Pediatric/Neonatal)

989803180521

277 Reusable 80 cm 5-lead cables with clip M1934A

278 Reusable 80 cm 9-lead cables with clip 989803180531

279 EC2™ Electrode Cream (conductive paste) M1937A

280 Optical Module 50131

281 Hospira Opticath® Catheter family (SvO2, ScvO2) Contact Hospira for part numbers of compatible

catheters

282 Philips SO2 Optical Module 989803151591

283 Pulsion: CeVOX Fiberoptic Probe family (ScvO2) Contact PULSION for part numbers of compatible probes 284 Edwards: Philips-compatible versions of the PreSep Catheter

(ScvO2) or Swan-Ganz Oximetry Catheter (SvO2) families

Contact Edwards for part numbers of compatible

catheters

285 IntelliVue NMT Patient Cable (reusable) 989803174581

286 NMT Hand Adapter (reusable) 989803199211

287 Lithium Ion Smart Battery 1 Ah (internal battery for X2) M4607A 288 Lithium Ion Smart Battery 2 Ah (internal battery for X3) 453564526811 289 Lithium Ion Smart Battery 6 Ah (for MX400/MX450/MX500/MX550) M4605A 290 Battery Charger and Conditioner (requires size adapter to charge

M4607A or 453564526811 battery)

865432

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Catatan:

291 Size adapter for M4607A battery 451261017451

292 Size adapter for 453564526811 battery 453564658631

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

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IntelliVue MX700 Patient Monitor

Philips 865241 Technical Data Sheet

The IntelliVue MX700 patient monitor offers a flexible and modular monitoring solution, designed to suit a broad spectrum of needs. The monitor can be connected to the Philips Multi-Measurement Module family with its extensions, plug-in measurement modules and the IntelliVue gas analyzers to extend its functionality with

plug-and-play convenience. Dedicated configurations are available for the anesthesia, critical, cardiac, and neonatal care environments. The integrated PC (iPC) allows access to relevant patient information residing on the hospital’s intranet.

Features

• Intuitive user interface.

• Easy-to-read, easy-to-use touch screen.

• Simple menu hierarchy gives fast access to all basic monitoring tasks.

• Screen layouts are easily adjustable, allowing flexible display of measurement information.

• Previous/Next Screen function provides access to the ten most recently used screens including the last three modified screens.

• Temperature, height, and weight can be configured either in metric or imperial units. Pressure measurements can be displayed in kPa or mmHg.

Gases can be displayed in kPa or mmHg.

• Patient data management with tabular and graphic trends, and high resolution trends to track changes with beat-to-beat resolution.

• Drug, ventilation, hemodynamic, and oxygenation calculations.

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• User or case-specific profiles enable rapid case turnover.

• Patented automatic alarm limits help clinicians provide care more efficiently.

• Alarm Advisor provides feedback on recurring and continuous alarm limit violations, helping clinicians to adapt alarm limits more specifically for individual patients.

• Event Surveillance including Neonatal Event Review (NER) for automatic detection of patient status deterioration.

• Guardian Early Warning Scoring (EWS) calculates a score based on vital signs to help recognize early signs of deterioration in patients.

• Tympanic Temperature measurement¹. In ear SpotCheck

thermometer, delivers accurate temperature readings in less than two seconds.

• Bed-to-bed overview provides clinicians with an overview of all the patient beds in their care.

• Choice of input devices: Touchscreen, trimknob, remote control, trackball, mouse, keyboard or barcode reader.

• Capable of functioning in a wireless infrastructure.

• Graphical measurement window shows which measurements are being measured by which device, making it easier to resolve measurement label conflicts.

• Timers application allows you to set timers to notify you when a specific time period has expired.

• Second independent display capability using the iPC.

• Additional display capability using IntelliVue XDS Remote Display.

• The iPC can host Windows applications and safely share the display with the monitor’s realtime system or drive a second display, independent of size and resolution. The content displayed on the second display can be different from the content on the main display of the monitor and can show either realtime vital signs information, PC applications, or both at the same time. A separate isolated LAN interface allows access to the hospital’s network independent of the monitor. Six USB interfaces provide connectivity to external computer devices, for example, printers or input devices such as the touch interface of the selected display.

• Bedside information access using the iPC, Portal technology, and/or IntelliVue XDS Clinical Workstation.

• XDS Database (option X40), enables the collection and storage of vital signs information (numeric data only - no waves), for example, heart rate, pressure, ... on an external SQL database.

Indications for Use

The monitor is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained

health care professionals in a hospital environment.

The monitor is only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitor is for prescription use only.

Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical

ventilation and mainly free from arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

Modularity

The monitor’s functionality can be extended by connecting Philips plug-in modules, the Multi-Measurement Module family with extensions, and gas analyzers - with plug-and-play convenience.

The monitor is available as standalone or networked solution.

The monitor’s modular design allows new capabilities to be added in the future as monitoring requirements change. This upgradability gives the security of knowing that the monitor can be enhanced and updated as practices and technologies advance, protecting long-term

investments.

1Requires Option J13 - MIB/RS232 interface.

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Main Components

Display

The monitor has a color 15 in LCD TFT display with a wide viewing angle, providing high resolution waveform and data presentation.

The monitor integrates the display and the processing unit into one device. One external display - providing an adaptive duplicate-image of the primary display - can be connected to a built-in DVI-I port.

A second independent display can be connected via the iPC. Multiple display resolutions including widescreen formats are supported on the iPC.

Remote Display

IntelliVue XDS Remote Display allows the remote display of an IntelliVue Patient Monitor1 on a PC which is connected to the same network. It can be configured to allow remote operation of the patient monitor. It is intended to be used as an additional display for viewing and operation by clinicians and nurses.

Integrated PC (iPC)

The iPC is a fan-less, medical grade PC residing within the monitor and as such designed for continuous operation in the patient vicinity.

The iPC is shipped with Windows 7 as operating system and can host applicable applications. These applications can either be:

– Windows applications, such as Internet Explorer,

– Philips applications such as iSite clients or an application launch pad, – Third party applications or

– Hospital owned and developed software.

The iPC is designed as an “open” PC and can be serviced and maintained by the hospital’s IT department as well as by Philips.

A separate isolated LAN interface allows access to the hospital’s network independent of the monitor.

The iPC can safely share the main display with the monitor (single display setup) and/or be used with a standard or a medical grade display (dual display setup), either provided by Philips or another manufacturer.

The iPC supports displays with or without touch operation.

The iPC has six USB ports (five at the rear and one at the side of the monitor) supporting High-Speed mode for computer peripherals such as keyboard, mouse, barcode reader, touch display etc.

User Interface

The color Graphical-User-Interface is designed for fast and intuitive operation, and ensures that clinicians quickly feel at ease using the monitor.

Configurable SmartKeys with intuitive icons allow monitoring tasks to be performed quickly and easily, directly on the monitor screen.

Waves and numerics are color-coded.

The monitor displays up to six² waves simultaneously. For 12-lead ECG monitoring it can display 12 real-time ECG waves, with a rhythm strip and all ST values.

Flexible screen layout allows optimal use of the available display space, for example, waves can be overlapped or wave size can adjust dynamically depending on the number of waves configured for the space.

The Basic Help provides on-screen operating help, explaining INOP and alarm messages.

Touchscreen Operation

The MX700 monitor is supplied as standard with a resistive touchscreen display.

Trimknob Operation

The monitor can also be operated via the Trimknob.

Hardkeys

To guarantee immediate access to the functions Audio Off/Paused, Alarms On/Off/Paused and Main Screen with the Trimknob operation, hardkeys are located next to the Trimknob.

Remote Control

The IntelliVue Remote Control 865244 provides direct access to five hardkeys, a navigation knob, and a numeric keypad which can also be used for alphanumeric entry. The hardkeys include “Silence”,

“Alarms Off / Pause Alarms”, “Back Key”, “Main Screen”, and a “SmartKeys” key that displays a block of configurable smart keys. The Remote Control is connected to the monitor via USB interface or SRR interface (wireless) and used for remote operation of the monitor.

Remote Alarm Device³ The Remote Alarm Device 866406 provides, when connected to a

patient monitor, audible and visual indicators of alarms, in addition to the indicators at the monitor.

Input Devices

Supported input devices include USB-compatible off-the-shelf computer accessories such as mouse, keyboard, trackball, or barcode reader. All input devices can be used individually or in combination.

1Requires Option X00 - XDS Connectivity to be installed on either the patient monitor, or on a PC running the IntelliVue XDS Solution with an activated license.

2Up to eight waves in selected countries.

3Requires Option J23 - Remote Device Interface.

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Mouse

Any specified USB mouse or trackball may be used for data entry.

Computer Keyboard

A USB-compatible off-the-shelf keyboard can be connected to the monitor for data entry.

Simulated Keyboard

If alpha or numeric data entry is required, for example to enter patient demographics, an on-screen keyboard will automatically appear on the screen.

Barcode Reader

A USB barcode reader in “keyboard emulation mode” can be used via a USB connection.

X1 Multi-Measurement Module (M3001A / M3001AL) The X1 Multi-Measurement

Module can be connected without cables onto the side of the Flexible Module Rack (FMS). The X1 can also be connected to the monitor or FMS with cables to place it in

patient vicinity. It sends measurement waves and numerics to the monitor screen and generates alarms and INOPs. Patient demographic details are stored in the X1. Eight hours of patient trends can be transferred to the monitor.

The X1 provides measurement data for Electrocardiogram (ECG)/

arrhythmia, respiration, oxygen saturation of arterial blood (SpO₂¹), noninvasive blood pressure (NBP), and invasive pressure or

temperature. It features 12-lead ECG capability, multi-lead arrhythmia, and 12-lead ST analysis.

X2 Multi-Measurement Module (M3002A) The X2

Multi-Measurement Module can be connected without cables onto the side of the Flexible Module Rack (FMS). The X2 can also be connected

to the monitor or FMS with cables to place it in patient vicinity. It sends measurement waves and numerics to the monitor screen and generates alarms and INOPs.

The X2 provides measurement data for electrocardiogram (ECG)/

arrhythmia, respiration, oxygen saturation of arterial blood (SpO₂²),

noninvasive blood pressure (NBP), and either invasive pressure and temperature or CO₂. It features 12-lead ECG capability, multi-lead arrhythmia, and 12-lead ST analysis. Combining its role as

Multi-Measurement Module with that of stand-alone monitor, the X2 is particularly suited to transport situations. When the X2 is

disconnected from the host monitor, it continues to monitor the patient as a stand-alone monitor running on battery power, eliminating the need for a separate transport monitor. When the X2 is

reconnected to a host monitor, it resumes its role as a

Multi-Measurement Module, uploading trend data, patient demographic information and measurement settings, and allowing fully continuous monitoring. The X2 can operate using battery power for over three hours with basic monitoring configuration to let you safely and easily monitor patients during in-hospital transfer. The X2 can also be used as a stand-alone monitor.

X3 Patient Monitor/Multi-Measurement Module (867030) The X3 can be used in two ways:

• As a stand-alone patient monitor.

• As a Multi-Measurement Module for the IntelliVue family of patient monitors.

The X3 can be connected without cables onto the side of the Flexible Module Rack (FMS). The X3 can

also be connected to a host monitor or FMS with cables to place it in patient vicinity. It sends measurement waves and numerics to the monitor screen and generates alarms and INOPs.

The X3 can simultaneously monitor 3-, 5-, 6-, or 10-lead ECG, including arrhythmia and ST monitoring, respiration, oxygen saturation of arterial blood (SpO₂), noninvasive blood pressure (NBP), two invasive pressures, temperature, and CO₂. The X3 stores data in trend databases. Combining its role as Multi-Measurement Module with that of stand-alone monitor, the X3 is particularly suited to transport situations. When the X3 is disconnected from the host monitor, it continues to monitor the patient as a stand-alone monitor running on battery power, eliminating the need for a separate transport monitor.

When the X3 is reconnected to a host monitor, it resumes its role as a Multi-Measurement Module, uploading trend data, patient demographic information and measurement settings, and allowing fully continuous monitoring. The X3 can operate using battery power for over five hours with basic monitoring configuration to let you safely and easily monitor patients during in-hospital transfer. During in-hospital transport the X3 can power the Measurement Extensions (867039, 867040, and 867041) without requiring the use of the IntelliVue Battery Extension (865279).

1Choice of Philips FAST SpO₂, Masimo SET SpO₂, Nellcor OxiMax SpO₂or Masimo rainbow SET SpO₂ (including certain Masimo rainbow Parameters).

2Choice of Philips FAST SpO₂, Masimo SET SpO₂, Nellcor OxiMax SpO₂ or Masimo rainbow SET SpO₂ (including certain Masimo rainbow Parameters).

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Measurement Extensions

The following Measurement Extensions can be slotted onto an X1, X2, or X3:

• The 867039 Hemodynamic extension: adds temperature, two pressures, and optionally cardiac output/PiCCO.

• The 867040 Capnography extension: adds mainstream/sidestream capnography, and optionally temperature, two pressures, and cardiac output/PiCCO.

• The 867041 Microstream® CO₂¹ extension: adds Microstream capnography, and optionally temperature, two pressures, and cardiac output/ PiCCO.

• The M3012A Hemodynamic extension: adds temperature, pressure, an additional pressure or a temperature and optionally cardiac output/PiCCO.

• The M3014A Capnography extension: adds mainstream and sidestream capnography, and optionally one pressure plus either a pressure or a temperature and cardiac output/PiCCO.

• The M3015A Microstream CO₂ extension: adds Microstream capnography, and optionally either pressure or temperature.

• The M3015B Microstream CO₂extension: adds Microstream capnography, and optionally two pressures and a temperature.

Flexible Module Racks with Plug-In Modules

The Flexible Module Rack FMS-8 (M8048A) - not shown - has eight slots for plug-in measurement modules, however only four modules (plus a recorder) are supported for use with the MX700. The Flexible Module Rack FMS-4 (865243) has four slots for plug-in measurement modules. The optional Flexible Module Racks (E04) with a

Multi-Measurement Module mount gives the possibility to mount an X1, X2, X3, and Measurement Extensions onto the side of the FMS-4 Flexible Module Racks.

Individual plug-in measurement modules are available to measure:

– M1006B Invasive Blood Pressure

– M1011A Intravascular Oxygen Saturation Module (SO₂) – M1012A Cardiac Output/Continuous Cardiac Output – M1014A Spirometry

– M1020B SpO₂

– M1027B Electroencephalograph (EEG/aEEG) – M1029A Temperature

– M1034B Bispectral Index (BIS^TM)²

– 865383 NeuroMuscular Transmission (NMT) – 866173 G7m Gas Analyzer

Additional plug-in modules available are:

– M1116C Thermal Array Recorder – 865115 EC10 IntelliBridge

IntelliVue Gas Analyzers

The versatile IntelliVue G1 and G5 gas analyzers, and the G7m gas analyzer module measure the five most commonly used anesthetic gases, as well as N₂O and CO₂. They all provide inspiration and expiration values for display on IntelliVue patient monitors and the values required for MAC calculation in the IntelliVue patient monitors.

The IntelliVue G1 gas analyzer measures the single agent chosen by the clinician. The IntelliVue G5/G7m feature automatic agent identification and mixed-agent measurement capability. Advanced O₂ technology based on paramagnetic measurements is optional with the G1 and included as standard with the G5/G7m. The TcG10 measures the transcutaneous O₂ and CO₂ partial pressure in neonates, pediatrics and adults.

Mounting

The standard mounting options enable flexible, space saving placement of the monitor for an ergonomic work space.

Applications for Specific Care Settings

Anesthesia Features

• The IntelliVue G1 and G5 gas analyzers and G7m gas analyzer module measure the five most commonly used anesthetic gases, as well as N₂O and CO₂.

• The BIS Module assesses the level of consciousness in the OR, providing a measure of the effect of anesthetic agents.

• The IntelliBridge EC10 Module provides external device interface capability to external devices at the bedside which have a serial RS232 and/or LAN output.

1Microstream is a registered trademark of Oridion Systems Ltd.

Flexible Module Rack FMS-4 (865243)

Optional Flexible Module Rack, FMS-4 (E04) with a Multi-Measurement Module mount

2Bispectral Index and BIS are registered trademarks of Covidien AG and/or its affiliates.

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• The EEG Module determines coma prognosis and extent of cerebral insult. CSA information can be either permanently displayed on specially designed screens or viewed in a separate window. Burst Suppression Ratio (BSR) indicates the amount of time within an interval spent in the suppressed state.

• The Spirometry Module provides airway pressure, volume and flow measurements to monitor changes in respiratory status.

• The NMT Module together with the NMT Patient Cable offers automatic measurements of muscle response to electrical stimuli delivered via electrodes placed over a peripheral nerve, this enables the evaluation of muscle relaxation of patients under neuromuscular block. The strength of the muscle response is measured with an acceleration sensor.

• Screens provide flexible viewing of patient information during different procedures or phases of an anesthesia case.

• Respiratory Loops. The IntelliVue patient monitor can generate three types of respiratory loops and display one real-time loop and up to six stored loops simultaneously. This assists in early detection of patient airway problems (for example, atelectasis, bronchospasm) and ventilator problems (for example, leaks and kinked tubes).

Critical and Cardiac Care Features

• The monitor performs multi-lead arrhythmia detection analysis on the patient’s ECG waveform at the bedside. It analyzes for ventricular arrhythmias, calculates heart rate, and generates alarms, including asystole, bradycardia, and ventricular fibrillation.

• Up to 12 leads of ST segment analysis can be performed on adult patients at the bedside, measuring ST segment elevation and depression and generating alarms and events. The user can trend ST changes, set high and low alarm limits, and set both ST and isoelectric measurement points. ST points can be set either relative to the J-point or directly by selecting a numeric value. Using ST Snippets, one-second wave segments can be compared with a baseline segment for each measured ST lead.

• QT/QTc interval monitoring provides the measured QT interval, the calculated heart-rate corrected QTc value and a ΔQTc value, which tracks variation in the QT interval in relation to a baseline value.

• SO₂ and ScvO₂ measurements provide guidance for the treatment of sepsis treatment protocols.

• The Parameter Histogram View of the Vital Signs Trend allows the clinician to see, at a glance, the stability of the patient's condition for a selected time period.

• ST Map application shows ST changes over time in two multi-axis spider diagrams.

• STE Map adds gender-specific STE limits to ST Map. ST values violating these limits are indicated in red.

• 12-lead ECG data can be measured in diagnostic quality, using conventional electrode placement with 10 electrodes. Alternatively it

can be measured using the EASI lead system with five electrodes in EASI placement or the Hexad lead system with six electrodes¹.

• High performance pulse oximetry technologies perform accurately even in cases with low perfusion.

• Choice of Microstream, sidestream and mainstream CO₂ monitoring for high-quality measurements with intubated and non-intubated patients.

• Continuous cardiac output and advanced hemodynamic assessment are provided using the PiCCO^TM method without a pulmonary catheter.²

• Integrated Pulmonary Index (IPI)³ enables clinicians to quickly and easily assess a patient’s ventilatory status and monitor changes in a patient’s condition, facilitating more timely interventions.

• Pulse Pressure Variation (PPV) is calculated from beat-to-beat arterial pressure values. Pulse pressure is the difference between the systolic and the diastolic pressure values for a single beat. Pulse pressure variation is defined as the maximal pressure less the minimum pressure, divided by the average of these two pressures.

• Clinical calculations enable stored and manually entered data to be used to perform hemodynamic, ventilation, and oxygenation calculations. Calculated data is displayed in both indexed and non-indexed format.

• BIS monitoring provides sedation assessment in critical and cardiac care environments.

• Spirometry measurements help to manage ventilator settings and weaning.

Neonatal Monitoring Features

• Transcutaneous gas (TcGas) monitoring helps to optimize respiratory therapy in neonates.

• Dual-Pulse Oximetry capability allows the clinician to measure pre- and post-ductal saturations.

• The Oxygen CardioRespiroGram (oxyCRG) screens provide a simultaneous presentation of up to three high-resolution trends:

– beat-to-beat heart rate (btbHR)

– an oxygenation measurement trend (SpO₂ or tcpO₂) – compressed respiration rate

• This customized display gives clinicians a convenient overview of the neonatal patient’s most important vital signs, helping them to identify significant events.

• Continuous oxyCRG recordings can be made at the bedside on the M1116C Recorder.

1EASI/Hexad-derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI/Hexad is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic purposes.

2PiCCO^TM is a trademark of Pulsion Medical Systems AG.

3Microstream CO₂ only.

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• Dual SpO₂ measurement provides clinical support through comparison and trending of the pulse oximetry values from two distinct patient sites.

• Trended values can also be viewed in the form of a histogram. The SpO₂ histograms can be trend histograms or real-time histograms with 1-second samples.

• Car Seat Assessment Record (CAR). This is a special period of event surveillance for neonates during a car seat test. During the CAR period, a real-time SpO₂ histogram is also generated with 1-second samples.

• Neonatal Event Review (NER), for automatic detection of patient status deterioration. NER is optimized for monitoring neonatal patients. For each event, an episode of four minutes of data sampled four times a second is stored, to help you keep a record of rapid changes in the condition of neonatal patients. Combi-events correlate apnea events with bradycardia and/or desaturations.

• The aEEG¹ presentation is a trend display of the amplitude-integrated EEG (aEEG). It uses amplitude compression samples. A trend of the sum of the electrode impedances of the respective lead is shown below the aEEG presentation as a quality indicator that supports interpretation of the aEEG. The monitor stores 24 hours of aEEG and electrodes impedances for all four channels.

IntelliVue Applications

Advanced Clinical Solutions

Clinicians are continuously drawing mental images from their observations of patients’ vital signs. The IntelliVue’s clinical decision support applications offer this dynamic “minds eye view” directly on the monitoring screen display.

ProtocolWatch

ProtocolWatch allows clinicians to run clinical protocols that can monitor developments in the patient’s condition. The SSC Sepsis Protocol runs on the ProtocolWatch application and is used in screening for severe sepsis and monitoring its treatment.

Guardian Early Warning Scoring (Guardian EWS)

The early warning scoring application provides fast, automated early warning scoring. Guardian EWS is fully customizable to match your hospital’s clinical protocols:

• Configurable scoring parameters and thresholds.

• Up to 20 parameters per EWS protocol.

• Configurable MEWS thresholds.

• Configurable Action List.

• Up to five EWS protocols per monitor.

Guardian EWS provides three basic types of scoring:

• Single Parameter Scoring (SPS).

• Multiple Parameter Scoring, for example:

– Modified Early Warning Scoring (MEWS) – UK National Early Warning Scoring (NEWS)

• Body System Structural Scoring, for example:

– Pediatric Early Warning Scores (Tucker Schema) – Adult Body System Scores

Vital signs and clinical observations can be configured for early warning scoring.

• Vital signs, for example; pulse, temperature.

• Clinical observations, for example; AVPU, Concern.

• Using customized labels, clinical observations can be labeled and defined according to a hospital’s particular requirements at the time of installation.

• ADT data, for example; weight, age.

• Lab data.

• Documentation.

Escalating Monitoring - If a patient’s condition is deteriorating or a closer observation is indicated in a particular situation, the monitor can be left with the patient and switched to a monitor profile that allows more frequent checking of vital signs.

The monitor comes with the following additional Profile:

• Frequent Vitals: Can be used if some vital signs need to be checked more frequently.

ST Map

ST Map provides a graphical display that can help clinicians to recognize ST changes and their location in the heart more easily. ST Map collects ST values created from the frontal (limb leads) and horizontal (chest leads) plane into an integrated display. The maps are multi-axis portraits of the patient’s ST segments as measured with the ST/AR arrhythmia algorithm.

Advanced Event Surveillance

Events are electronic records of episodes in the patient’s condition.

They can be used to drive alert notification to assist compliance to any protocol that is being used by the clinician.

Horizon Display

Horizon trends provide clinicians with a graphical visualization tool that allows the end user to detect at a glance the patients’ current clinical status. By combining parameters together on the display, the clinician is assisted in their cognitive process of pattern recognition.

Loops

Up to six loops of each type can be stored and compared to detect respiratory changes more easily.

1Patient monitor software option C60.

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Screen Display Flexibility

Up to 20 different screens can be created per monitor, which means that the clinician has the ability to have a screen created to match a specific clinical scenario on which the data that matters is displayed.

This streamlines the information that needs to be processed and interpreted to make the right decision at the right time.

Trends

• A standard trends database configuration is provided, designed to suit specific application areas. Patient data from up to

32 measurement numerics can be sampled every 12 seconds, one minute, or five minutes, and stored for a period ranging from 4 to 48 hours.

• Tabular Trends (Vital Signs) show data for all measurement numerics in tabular form. Tabular Trends can either be viewed in a separate window or permanently displayed on specially designed screens.

– Each NBP measurement generates a column in the Vital Signs trend table. The values for the other measurements are added to provide a complete vital signs set for the NBP measurement time.

• With Graphic Trends, up to three rows of measurement trends can be displayed in graphic form, each combining up to four

measurements. Graphical Trends can either be viewed in a separate window or permanently displayed on specially designed screens.

• Screen Trends permanently display trend data for periodic and aperiodic parameters in graphical format on special screens. The displayed time period can be set to 30 min, 1 h, 2 h or 4 h.

• High Resolution Trends allow the user to track fast-changing measurement trends with beat-to-beat resolution (four samples/

second). The number of High Resolution Trends available for display depends on the wave option purchased.

• Horizon Trends show the deviation from a stored baseline.

• Trended values can be viewed in the form of a histogram. The SpO₂ histograms can be Trend Histograms with 1-second samples.

• Navigation arrows provide easy access to the stored trends. Trend data can be documented on a locally or remotely connected printer.

• With Event Surveillance, changes in patients’ condition are automatically detected and an electronic record of data called an Episode is stored. The Episode can store:

– 15 seconds of high-resolution wave trace

– four minutes of data sampled four times a second, or – 20 minutes of data sampled every 12 seconds

Event triggers can use the preset alarm limits or they can be user-defined. With user-defined triggers, event episodes are stored even when alarms are paused. A Manual Event SmartKey enables manual episode storage.

Event Annotation allows immediate or retrospective annotation of events using a user-defined list of event markers such as “ventilated”.

Events can be stored in a database for retrospective review, and episode data including graphic event reviews can be documented on a

local or central printer. In addition, episode data without graphic elements can be documented on the M1116C Recorder Module.

Events are also marked on the Event Line of an Information Center.

The Basic Event Surveillance package includes one Event Group plus the OxyCRG Group. Up to 50 event episodes can be stored over a 24 hour-period.

The Advanced Event Surveillance package offers increased storage capability, enabling the monitor to store data from up to 100 events over a 48-hour period. Up to six user-defined Event Groups can be configured, each made up of up to four measurements. All six groups can be active at the same time. Advanced user-configurable trigger mechanisms allow the clinician to define event triggers combining information from up to four measurements. Either alarm limits or user-defined thresholds or deviations can be configured as event triggers. The user can set event notifications in order to be notified when an event is detected.

Patient Management

• Universal admission/discharge/transfer (ADT) all ADT information is shared between the networked monitor and the Philips Information Center. Information need only be entered once.

• Stat Admit: allows you to admit a patient with a temporary patient identification. It can be used in cases when the patient ID is unknown or when the data is not yet available.

• Quick Admit: allows you to quickly admit a patient using only a limited set of demographic data. You can enter the data with the keyboard or a barcode scanner.

• Patients can be transferred by disconnecting the Multi-Measurement Module, X2, or X3 from a monitor, and then reconnecting it at a new monitor. Patient demographics are stored in the Multi-Measurement Module, X2, or X3, so they do not have to be re-entered at the new monitor.

Patient Data Documentation

• An extensive range of Patient Reports can be printed:

– Event Review and Episode Reports – 12-lead ECG Reports

– Vital Signs – Graphic Trends – Cardiac Output Reports – Wedge Procedure Reports – Calculations Reports – EEG Report – Histogram Reports – Loops Report – ST Map Reports – QT Reports – Alarm Limit Reports – Drug Calculator Reports