KE]IE\TERIA\ KESEHATA\ RI

DIREKTORAT JENDERAL
BINA KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said BIok X5 Kavling - 9 Jakana 12950
-1

Telepon: (021) 5201590 Pesa*'at:029. 8011 Faksimile : (021) 52964838 Kotak Pos : 203

Berdasarkan:

Peraturan Menteri Kesehatan R.l No.1 190/N4enkes/Per^/lll/2010 tanggal 23 Agustus 2010
tentang lzin Edar Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga

dengan ini diberikan persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20502011974

Nama : PHILIPS PAGEWRITER TC50

Jenis Produk : Electrocardiograph

HS Code :9018.11.00.00

Kategori : Peralatan Kardiologi

Sub Kategori : Peralatan Kardiologi

Type / Ukuran : 860310

Kemasan : Unit

Nama Pabrik :PHILIPS
Nama Pendaftar : PT. P bouurRctRL., ..tatatrta

Atas dasar lisensi dari

Ketentuan edar berlaku sampai dengan 3 Desember 2018.
laporan berkala setiap 1 (satu) tahun
p/i€nis dan akibat samping dari produk yang diedarkan.
ini merupakan persetujuan perpanjangan, perubahan
pendaftar danpenambahan aksesoris dari nomor
AKL 20502011974 tanggal 9 Agustus 2010. Dengan
ikian izin edar yang lama tidak berlaku lagi.

Persyaratan di kemudian hari ada pihak lain yang lebih berhak atas
keagenan di atas, sesuai ketentuan yang berlaku, pendaftar
bersedia melepaskan keagenan produk tersebut.
Apabila di kemudian hari terdapat kekeliruan, maka persetujuan
ini akan ditinjau kembali.

3 Desember 2013

ksi dan Distribusi Alat Kesehatan

drq. Ariahti Anava. MKM

neonate ECG TRANSMISSION Yes Type LAN. ID no. pediatric. ecgs 200 Expandable. 16 + rhl. optional wireless 802. of traces 12. departnent. db I l0 Leads-off signal Location on screen BAT]ERY OPERAIED Yes Kind ofbattery Lithium-ion SMART No. age. philips MODEL Pagewriter TC50 LEADS Switching Automatic. Jakarta..20 Calibration proce&re Automatic Diagnostic 0-r 50 Filtered Artifact rejectioL baseline wand€r hput impedarug 100 megohms Cmrr at 60 hz... ecgs 200 with optional USB device POWER NEEDED 110D20 vAC '{* I dan dipasarkan oleh lndonesia Commercial. 15. Manufacturer Specifications . clinical info. 60 Charging time. gender.. AKL . weight heighl 8 optional fields DISPLAY 25.8 Duratioq hr./voltage 2^0. . opffator ID.PageWriter TC5O. room.4 cm (10") TFT touchscreer No. Name. nanual Sellsitivity. no. race. hr 5 1fulJ capacitt. no. USA Rt. mrn/mv 5.tlm MICROPROCESSOR PROGRAMS Adult and p€diatic resting ECG Keyboard 34 Normal.11(g) and modem PATIENT INFO. facility.. PATIENT TYPE Adult. lndonesia Medical Systems. order info.. 10.

.. AKL . Ltd.. :ffiii.. Jakarta Manufactured' ffi1 Philips Medical Systems. Singapore \ Kemenkes Rl. 2 ?#---:+-\ . PageWriter TC 5 0 Cardiograph Diimpod dan dipasarkan oleh PT... Philips lndonesia Commercial. USA #€$ui Philips Electronics Singapore Pte.fuil=. r.l .{-i#Qh.

3 Desember 2013 M17158 tvl1716 B 989803129171 989803129181 989803129201 .r iing I . Rasuna Sajd Blok -\j K.rnrie:(0ll)5196'+E38 Kotak Pos:l(]i LAMPIRAN NOMOR IZIN EDAR ALAT KESEHATAN KEMENKES RI AKL 20502011974 Tanggal.L Kl-\-\ t\LsbH-\IA-\ ttl DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan H.9 Jakana ll9j0 Telepon : (021 ) 5101590 Pesau at 1019.R. S01 I Fak.KE-\Itr-\ l.

:r irne J .ECTRODE.. 1 TEMPERATURE PROBE IBOX OF 2O'5 SURFAcE TEMPERATURE PRoBE ANT NIBP CUFF .R. t\l-_rrr--_ \ r r ltl 1_\ I\t.9 Jakana 1195() Telepon:(021) 5101590 Pesau ar :0:9._rI Il_1 l_1 _\ l\I DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan H. 30I i Faksimile:(0ll )-i:96lEl8 Kotak Pos:103 SOLID GEL EI.qoaora PAED NIBP CI]FF 4040{B 86 ELOOD PRESSI. Ra:rina Satd Blok \-< I.R: CJ:: .

_ L II_-A I _-.I DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN .SHP-989803129161 BARCODE SCANNER FOR PHILIPS PAGEWRITER TOUCH BATTERY FOR PN TOUCH CHEST LEAD SET ISET OF PATIENT MODULE FOR PAGEWRITER TRI PAGEWRITER TRIM BATTERY RECORDING PAPER {BOX OF SINGLE SPIRAL FETAL DIRECT 3 LEAD SET GRABB LE HEIGHT SUPPORT ARM TTERY PACK IFRl NVASIVE BLOOD PR ESSU R E MODU tE M 10068 133 ADAPTER CIB:: . RasLrna '-i:ird Bl.R. ItI_ l-_ \ l\ Il.ialan H. Sr)11 Faksimiic:(011)5196-+E-lE Kotak Pos : 103 WELSH ELECTRODE WITH POSH-IN CONNECTOR 11 BX = 6 1 CHANNEL CHEMICAL THERMAL PAPER 4OX5OX3O. I\I-_vI I] _\ I l.5MM LEAD ADAPTER TO SNAP ELECTRODE 11 PA( = 10 ROLLS OF THERMAL ARRAY RECORDER PAPER '1 LIMB PLATE ELECTRODE LVER CHLORIDE ELECTRODES IBOX OF UNIVERSAL ETECTRODES 11 BOX = 4 SNAP LEAD ADAPTER WIDE SNAP/TOP ELECTRODE ADAPTER HIGH DENSITY MANAGED SWITCH DISPOSABLE TELEMETRY WSNAPS IBOX OF COMPLETE LEAD SET lPlN:.f-_ \ Il..l \: K:r ling J .9 Jekarra 1195i) Telepon:(011)510159(r Pesaqrt 1019.

3-LEADS SET 3 LEAD ECG PATIENT TRUNK CABLE 5 LEAD ECG PATIENT TRUNK 5 LEAD ECG PATIENT TRUNK 3 LEAD IEC TRUNK CABLE O 5 LEAD IEC TRUNK CABLE ADULT. \ _L l--I\l_1_\ I\ I -. GRABBER SET. irne -1 . _tr r.9 .II_1 I_1 _\ I\I DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan H. TRANSDUCER SERIES 5OA ULTRASOUND TRANSDUCER REUSABLE DECG LEG PLATE ADAPTER CABLE STANDARD AIRWAY ADAPTER 3. r\I. ADULI FOR NIBP CUFF SET.LEAD ECG PATIENT CABLE ORGANIZER FOR SHEILDED.R. SNAP CONNECTOR 5 LEAD SET GRAEEERS SAFETY AAMI M1521A 119 5H ELDED 5 LEAD SET M 16 25A 180 0e 5::Af 5- .)ll F.(0:L )5196-+E-18 Kotak Pos:10-l THERMAL ARRAY RECORDER PHILIPS DISPOSABLE INFANT 5PO25EN50R ADULT FINGER SPO2 SENSOR REUSABtE ADUTT SP02 FINGER SENSOR REUSABLE ADULT SPO2 FINGER ADULT FINGER SPO2 SENSOR REUSABLE PAEDS SPO2 SENSOR REUSABLE 5PO2 EAR PROBE INFANT FINGER SPO2 SENSOR ADULT REUSABLE SP02 LIP SENSOR REUSAELE ADULT 5PO2 FINGER SENSOR CLIP SERIES 50 TOCO EXT.i Blok \: Kl. SNAP EI-ECTRODE CONNECTS AIRWAY ADAPTER 3-LEAO 5ET.3(. Rasuna -Sai. I..rkrinrile.Takana 11950 Telepon: (011)5101590 Pesa\\at ll)19._.

ny(roapr).u. or*owfolv| c*f. E0I I Fak:inile:(011)5:96+E. ICU '1 M76724 195 3 LEAD GRABBER IEC / \)/ M1678A 196 L91 Ecc pApER FoR Hp M17o9A COMPLETE LEAD SET FOR PWXL volr z-FO LD [2oosHrlpaottepriCaSey' {\ peaewarrfx./ r\./ 'v(rtr nlsrt. M17 424 ^ 202 INTERNAL PEDIATRIC PADDLE SET / M1743A 203 TNTERNAL LARGE ADUII enoole srr .r. SNAP.orrr. oo#s.1t Kotak Pos : 103 181 s-LEAD SHIELDED M1633A 182 5 LEAD SNAP M1635A 183 CARDIAC OUTPUT CABLE Mt642A L84 5-LEAD ECG LEADS.41868A 209 NrBp cuFF NEoNATAT #egf'Itox or zo cul M1870A 2to r ar cr rr r "ro"ot4lt../aaee 192 3 LEAD ECG TRUNK CABLE f.Eldo{.or*6'/o&r/ 6plpeR Ir cnse or ao'sr M1913A ErcoZfircnd\xer /ir rrlrrn lrrur srr laox oF 2s's) M1920A 216 rrffiLrr./ M17444 204 syN CABLE FoR HEARtstaat xtltz ptrt /7 / M1783A ^ 205 EITE GUARD '/ /f/^ / M1828A 206 PRoBEREcTAL30rNer^torq/rN U / / / M1837A 207 / NrBp cuFF NEoNATA ts'r. *(soR ADAprrR cABLE coNNEcroR M1940A . GRABBER OR M1974A 226 LEADSII CFlEST ICU IEC M 1-o 7gA' 227 AD!LT:OA\t E Ea-?O li .re serlaNdrf's1 M1921A 2t7 d fqNoDrlu.7 M M1949A 223 s-r-rr6 srr M1958A 224 tols-r-rro rcc M1971A 225 LEADSET.9.u*. rostt M1937A 218.o1A oo orE R cA B LE "{o. I\l-_rl t .oM (8-prN) M1943At 122 ecc rR (r clsLe nnMr.77 /*reego 193 3 TEAD SET GRABBER AAMI.R./ M77 474 201 TNTERNAL pADDLEs ELEcTRoDEs DTAMETE urfr a.p*bb2o #rst M7A72A 2rt ._ \ r r.ltr_.Nson (a(E or za'st M19028 273 . ICU \\ // M1571A 794 3 LEAD SET GRABBER IEC.1 _ \ t\r--'l-rr_tr _1_ \ rtr DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan Ll.rn so* cor. PROBE / M16454 747 RADIOTRANSLUCENT SAFETY 5 LEAD SET M164eA / 188 WATER TRAP [BOX OF 25 TRAP5] *rc$6 / 189 GAS TUETNG IBOX OF 20 TUBtNGS] / #48( 190 10 LEAD ECG IRUNK (r{to 191 5 LEAD ECG TRUNK CABTE .ttg#l{ M1866A 208 NIBP cuFF srzE#2 to.A M1941A lzzo ru Lttr(^cf.lakana 1l95tt Telepon : (01l) 5101590 Pe:au at l{)19. or/o cu+s*.ort**/oorr^ r40 pADs/cAsEl M1911A 274 rr. AMI Iteooo / 185 5 LEAD PATIENT CAELE M164sA / 185 PICO TEMP. M1943A 22r sp02 8-pr!/D-suB ADAPTER cABLE 3.-/ . Rasunr Said Blrk \5 Kar i:ng J .fl/ / \>. rEc 2. / M19008 112 rNrrNr orspo{e}arpo)sg.r./ / M1709A M17138 t1< 198 12 LEAD-AcID BATTERv FoR M1702A M1721A 199 3 LEAD MONITORING PATIENT CABLE / tvl1735A 200 INTERNAL PADDLE \\ .rrn)lr./ \r/ .

C*" .i\tr rfrg orr.PAI)-as .t./c6eo. Mfcno cu rr tfa r e rar M4554A 258 rnsv cnne currEfnrr noun renV ^/ M4S54B 2s9 ort'r.rrro*ooe s 272 s M4513A : 271 6.}-o! r-r sr Nq{E Hose M4555A 260 EASYcREaiF/{Lr}L} / M45558 26r . l(lll Fiksrnrile:t0ll):19618-1ti Kotak Pos:103 228 TAB ELECTRODE ADA IPKT OF 1O'S] M22544 229 PATIENT C4BLE ORGANIZER IPKT OF 8'S] M228LA 230 LEAD ACID BATTERY ASSEMBLY M2460A 23L THERMAL PAPER FOTECG [8OX OF 8 REAMS] fiz+au / 232 THERJV]AL PAPER.zdi / 236 3 LEAD SNAP sET { 237 5 LEAD 5ET SNAP iu{to 238 5 LEAD SET AAMI vf.t"rru{r. M4557A ^#ngLe 263 ner(aeLr cur-F6# oourt.Box oF 1o's) M457 48 268 DlsPosABlf ADULT CUFF (BOX OF 10'. 247 REUSABLE SIDE STREAM CO2 SENSOR./1 M3703A 249 THERMAL PAPER ''C l\\ / M3708A 250 TEST LEAD / M372SA 'fi. \ I I-ILl-\-\ I\I-.INTUBATED / 'r"1 / M274rA 242 CO2lO2 NASAL CANNULA ADULT / \)/ M2750A 243 244 AIRWAY ADAPTER SET HANDS FREE ELECTRODE CABLE / /f// \>. NON. r./{\ / M2758A M3s08A 245 246 )47 SEALED LEAD ACID BATTERY BATTERY FOR HEARISTART MRX ECG PATIENT CABLE AND LEADS / /{< \\.Takarra ll95(| Telepon : (021 ) 5201590 Pesanat 1019. 44 SIZE.-ro ce. rr./ / M35164 M3538A M3702C 248 PATIENT ABLE & LEAD CHARCOO'. c*or. Z-FOLD {8/CASE) M2483A / 233 ANTr-FADE PAqER.fr or/dryft oo'ttr*t M45744 lzet waV/rrf "{ut .7} A / 25L BATTERY RECHARGEA U"'''OA M3848A 'OA 2s2 FR2 LrLoN BArrERy cHARGER / /f /^ / M3849A 253 DATACARD & rRAY Fo ry{t /f </ J / / M3854A ^r^rt FR2 sERrEs TNFANT/C rtro rr6^&ufuy'/ 254 / M3870A 255 EcG LEADsEt 3 rEAD.rro*./ . .-'l-lI-I-L-I.. Nrap M45578 264 zf .A / 23s SINGLE PATIENT USE ADULT AIRWAY ADAPTOR (BOX OF 1O'S) .9 . /rzsgeo 244 MOBILE CART / \\// / M2-740A.uc) \-/ / M39144 256 ANrMrcRoBrAr NrBP #A / M45538 257 srurarr no u lr *i!*. I\L/ t-t l-. 44 StZE (10/CASE) / M2486A 234 MAINSTREAM CO2 SENSOR M25O].rr Irns -+ .OCM 5W TCHED INTERNAL PADDLES 274 4 sCM 5W TClr:D \-:?NA.E tb$.afru ilre rr'.\i K.sryl6 (.*o'o. \ ItI DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan H.sgta 239 5 LEAD SET SNAP IEC //.R. rcc. utn r-r orrn rr M4559A 265/ '-A(rrru\ / M45598 . Rasuna Said Biok .S) M4575A 269 orseoydrr nourr cuFF (Box oF 10's) M45758 270 otsfnarr lrree cuFF-DouBLE HosE M45858 211 rt(tuworu aatrrnv M4605A (o./o{<// / M4556A 262 Loocrdo r.

4M ADULT SMART PADS CARTRIDGE SLIM CARRY CASE FOR HSI FLEXIBLE MODULE SERVER Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk tercantum dalam lampiran ini. Direktur. I\l--J -ll l--r .I DIREKTORAT JENDERAL BINA KEFARMASIAN DAN ALAT KESEHATAN Jalan H.9 Jakarta 12950 Telepon : (021) 5201590 Pesarvat_ 2029. Alat Kesehatan . \ l\lr \-'lJ lI--I I --L . n.\ I I-ltI--L. Rasuna Said Blok X5 Kar ling -1 . a.8CM SPO2 SENSOR EXTENSION CABLE 2. 801 I Faksimile : (021) 52964838 Kotak Pos : 203 INTERNAL SWITCH PADDLE 2.R.I Il.