KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

./
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Sa d Blokx-s Kaving 4- 9 Jakarta 12950
4w
Teepon:(021) 5201590 tusawat 2029, 8011
Faksimle : (021) 52964838 Kotak Pos : 203
G ERMA
"(

BerdasarkanPeraturanMenterKesehatanR,Nomor62Tahun20lTTentanglzinEdarAlaiKesehalan
Alat Kesehatan Diagnost k n Vitro Dan Petuekalan Kesehalan Rumah Tangga dengan ni diberikan
persetujuan uniuk diedarkan denga. :

NOI\,4OR IZIN EDAR

A LAT KE SE H ATAN

KEMENKES RI AKL 30503710404

Nama Dagang / Iverek ' TFLEFLEX ARROW AUTOCAT 2 WAVE lntra Aortic Balloon

Kelompok / Kelas Resiko Eleklfomed k Non Radias / D

KategoriProduk Pera atan Kard olog

Sub Kaiegori Peralatan Kardiologi Prostetik

Jenis Produk lntra-aort c balloon and conlrol system

Tipe / Ukuran rAP-0500

Kemasan lln t
Nama Produsen / Pabrikan ARRoW INTERNAT ONAL. lNC.. United Stales
lv'lelal!i TELEFLEX MEDICAL, lreland

Nama Pendaftar PT MIJLTIDAYA [.4EDlKA. DKlJakafta

Atas dasar lisensi dari

Ketentuan
1. Persetujuan izin edar benaku sampaldengan 20 oktober 2019.
2. Wajib menyampa kan aporan berkaia dan laporan jika ada kelad an vang tidak diinginkan akibai
penggunaan Alal Kesehatan tersebut diatas sesuai ketenluan berlaku.
3. lzin edar ini merupakan persetuiuan perpanlangan dari nomor pendaftaran Alat Kesehatan AKL
30503710404 tangqal02 Me 2017 Dengan demikian lzin edaryang lamatidak berlaku lagi.
4. Apabila dikemLrdian har ada plhak lain yang berhak atas merek dan/alau keagenan produk
tersebut, pendaftar bersedia menqemba ikan izin edar'
5. Penandaan dan inforrnasi produk yang terlamplr merupakan bagian yang tidak terpisahkan dari
Persetujuan izln edar lni.
6. Apabila di kemudan hari terdapai kekelruan, maka persetujuan izin edar inl akan ditinjau
kembali.

06 Februar;2018
Direktur Jenderal

Dra. Ph.D
N IP, 19580503 198303 2 001
.3
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTOMT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
la an H.R. Rasuna Said BokX-5 Kavling4-9Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
g
\
Faks mile : (021) 52964838 Kotak Pos | 203
GERMA

LAMPIRAN
NOIVIOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 30503710404
Tanggal, 06 Februari 2018

No. Deskripsi Tipe / Kode

1 3/16 Tube Wyes (2500 9300 026)
2 Upgrades ACAT@2 system to AutoCAT@2 system ACAT@2 to wth
AuioPilotru function
3 Upgrades ACAT@2 sislem 1o AutoCAT@2 s stem dengan AutoPiloirM
function, WAVE t ming dan F ber Optic Arierial Pressure mon tor ng
capability.
Upgrades AutoCATai)2 slst€m to AutoCATO2 WAVE sistem dengan
WAVE iiming dan F ber Opl c Arter al Pressure mon 1or ng capabiliiy.
5 Converts stdanard AutoCAT[r2 IABP s stem to Aero AutoCATaO2
confl guration for transport.
6 Converls stdanard AutoCAT@2 WAVE IABP slstem to AeroAulocai
2 WAVE confguraton for transport.
7 Complete 5 lead ECG cable cons sting of one IAA 09838 dan one
IAA-09839 (15 ft/4.511) Al-lA(US) Clip colors
I Complete 5 lead ECG cable cons st ng of onc IAA 09838 dan one
lM-09839E (151U4.5[n] 1EC (ELrropean Clp cokrrs)
I Five lead rnain larnk .ai) e (l2 f1/3 7Ml
10 Five lead pauent cabl,., clp ends (3Sirr/1M)AHA (US)Colors
11 Flve lead patentcabk: .lp srds (391n/1M) EC (E!ropean) Colors
12 Tubing Tygon Clear 5/16 OD x 3/16 lD (3100-0015 00T )
13 Attaches to Conlvled/NDN4 Backpad ECG eleckode
14 Assembly : lnteriace Block AutoCAT2 (77 3012 001)
15 Cable for connecting ECG alau AP monilor s gnal to AutoCAT@2
Series (25 Fr 8 M)
16 For connecling ECG alau AP lrom Hew ett Packard monltors to
AutoCAT@2 Series (25{UB M)
17 For connecting ECG atau AP frorn Spacelabs monitors to
AutoCAT@2 Series (25fU8 1,1)
18 For connecting ECG atau AP from Siemens monlior 9000 series to
AutoCAT@2 Series (2slUB M)
19 For connecting ECG dan AP fro0) S emens monitor 1280 ser es to
AuioCAT@2 Serles (251i18 Nl)
2A GE/Marquelte 7010 Cable nssemlrly connects ECG dan AP signal
21 GE/Marquette Lemo Connecior Assembly connects ECG dan AP
signal

Lampiran 1 dari4 Ha aman

.r KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said BlokX-5 Kaviing 4-9Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Fakimile : (021) 52964838 Kotak Pos i 203
g
G ERMA

No. Deskripsi Tipe / Kode

22 10 roll box of 50mm blark the.mal paper for AutoCAT@2 Serles str p
chart recorder. (275it per rol)
23 Case of4 disposable can slers 33 iiels @ 500 ps
24 Rellllable dengan std.nar.l yoke flting dan European (BA[,4.)
approval, 100 lters @ 2900 psi
25 Refillable dengan stdanard yoke ftting dan US approval, 106 liters @
2000 psi
26 Adapter which allows 500 psi disposable tangki to be used in
stdanard yoke assembly
27 Fits between tangk dani:rtau t:f9k adapter to seal tangk
2a Adhesive card describing the steps to change a disposable helium
tangki. The card is des goed lo be rnounled on the nside ofthe
Helium compartmeni door (Englsh only).
[,4onitor to control un I cable ] 2 ft Stdanar.l Lcn{rlh
30 lnteracUve hemodynanr c ECGiAP/Axillary pressure simulator;
batemi operated. compL ter based train ng sistem produces
synchronized ECG AP dan aux iary pressure waveforms at different
pulse rates, includ ng dysrhythm as when used dengan the
AuioCAT@2 Series; inc !des baterai charger 3 phone-RCA cables
31 1 ow nlernatlona Nlode 270T ABsimuator
1SV AC Charger 1!r Ar
220V AC Charger for Arrcw ntcrfatror)a l,4o.lel 270T IAB s mulator
33 Arrow Pneumaiic Cont,(, Syslem &#40.96-3006 001W)
34 Load slmulator to srmrlate AB atlached lo Affow IABP srslems.
Prov des cal braled fl!id .olumn to \rer I kasr vo ume displacement.
35 Augmeniauon Chanrbcr (.15!0 9100 004)
36 Arrow Model2001 nira Aorllc Pump S mulator (220V1 Balloon Pump
Console Inleraclive Hemoaynarn c ECG/AP/Auxiliary Pressure
Tralning Simulator (Conrpofenls as llsted above Continental
European Plug.)
37 AutoCAT2 Series Pump Assembly (77 3200-001W)
38 Augmentat on Valv-" Assenrbly (77'302/l-001)
39 Low LevelArter a Pressure Cab e with 4.4 mrn plug to 6 Pin AA[,4]
connector (For use wth Transacl IABP systems)
40 Low LevelArterial Pressure Cable wth 4.4 mm plug to 6 Pin AAN,4l
connector (For use w th AutoCATrti IABP systems)
41 Assist oul to 4.4 mm plug (For L se with Dalascope IABP systenrs)
42 I Pin DB to I Pin DB (For use wiih TransAct@ or AutoCATrM IABP
systems)
43 Phone-to-Phone cab c (10 [t/3M)
44 AutoCAT@2 Series Opcrator s \4anua (sofiware 2 21 or lower)
Available in : Germaf Sfr.rf slr Frcnch ltalian Japarese

Lampiran 2 dari4 Ha amar

 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said BokX-5 Kavling 4 - 9lakarta 12950
Telepon | (021) 5201590 Pesawat 2029, 8011
Fakimile : (021) 52964838 Kotak Pos : 203
g
G ERMA

No. Deskripsi Tipe / Kode

45 AutoCAT@2 Series Service Manual (software 2.21 or lowe, English
Only
46 AUIoCATG)2 Ser es Operator s Man!al (software 2 22 or h ghe4
Ava lable in : Germa. Spanish French
AutoCAT@2 Series Senr'ice Manual (software 2.22 or higher) Englsh
Only
4A lV Pole l\,lounting Brackel
49 Aircraft Lockdown Bracket
50 Dual Hanger lV Po e
51 Short DualHanger lV Pole
52 Detachable power cord dengan North American plug configuration.
( 2 fu3.5 t\r)
53 Deiachable power cord dengan North American p uq configuraUon.
(15 ft/4.5 M)
54 Detachable power cor.l den.ran cont fental European plug
conllquration. (12 ft/3 5 M)
Detachable power cord dengan cont Irental E!rop,.an p ug
configuration. (T5 fU4.5 Lrl)
56 5Detachable power cord dengan Auslralan plug confguration (15
fu4.5 t\.4)
57 Oetachable power cord de.llan llK p u{r confiqLrralon. (15 ft/4 5 M)
58 12 V Battery for DC oper:rl on
59 Extends battery life of AutoCATO2 Ser es ABP system min mum of
90 minLrtes to a mrn rrLrnr ol Tti{l nr nutes. lncludes cablng
60 5 x 20 mm AC luse raled al 5 ampere 250 Vo I
61 6.3 x 20 mm AC fuso ral-.C a( 6.3 ampere 250 Voll
62 Side rnounting cllp on ba_oftx man!als dan accessory storage.
63 Clear plast c covers for lnpuUOuiput tacks, io prevent dust dan fluid
ingress inlo the AUIoCATG)2 Ser es ABP
64 Tool used to access FOS membrane nternalto the AutoCAT@2
WAVE IABP for cleaning.
65 Swab for cleaning FOS sr:nsor
Prejilied alcohol swab lor . ean fg FOS sefsor on lAB.
67 Replacement lnserton K t for use with Frberoptix 8F, 30cc and 40cc
68 Brard RPr-fo,.eo D\, .l 00-00 i00,
69 Tubing Tygon 1/8 D x 114 OD 13100-9100 004)
7A Driveline Tub ng wrth Pr. nttach{:d Arow 30cc PLrmp Conneclor
l1 Driveline Tub ng wll r P e-altached Arrow 4Occ Pump Connector
72 Driveline Tub ng with Prc attrirhed Atrow 50cc Pump Connector
73 Drivelne Tubing for !sc w Lh TransAct PLrmp and F berOptix Cath

Lampiran 3da 4 Halamar

 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Sald Blok X-5 Kav ng 4 - 9 Jakarta 12950
Teepon:(021) 5201590 Pesawat 2029, 8011
!
\e'
Faksimie : (021) 52964838 Kotak Pos : 203
ERMA
"(

No. Tipe / Kode

74 Driveline Tub ng for use w tir DaLascope Ballor Pur.ps and
Fiberoptix 30cc 40cc Cath
75 Drlveline Tubing for Lrsc with Datascope Ballon Pumps and
Fiberoptix 50cc Cath

Dengan ketentuan bahwa zin l,dar iersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran nl

06 Februar 2018
DirektLrr Jenderal

Lampiran 4 dari4 Halamar

lntra Aortic Ballon Pump (IABP)

Arrow-AUIoCAT2WAVE

IABP System includes:

1. Fiberoptix Sensor Technology;
2. WAVE algorithm: Physiologically based;
3. Proprietary timing algorithm;
4. Aortic flow timing method;
5. AutoPilot mode of operation.

Nama Pabrik : Arrow international, lnc

Alamat Pabrik :9Plymounth Street Everet,

Massachusetts 02149 USA

Diedarkan Oleh:
PT. MULTIDAYA MEDIKA
Rukan Niaga Gunung Sahari Blok B-t
KEMENKES-RI AKL No:
 PRODUCT SPECIFICATIONS

,.i
1l
' '1,
ri,;i tj ,i, ll
:
rr

OESIGN CONDENSATION REMOVAL

. Fibe.Oplix..aprbihy: . Thernoeicctri. sysrcm removes moisrure continuously fr.m
-AP signal oansmitt.d at spe€d oflight pnenm,tic sysrem ,lhout intufiuprj ng .ounrerpdsatioo
. Proprieiary WAVEo algo.nhh
. Prop.ietaryAortic llow Timing Merhod SYSTEM MODES
. AuroPilof- mode or operalion
. Midop.ocessor-based sysl€m architecture - Autonalically selecls DCG/AP signal, sourccs, tigge. modc,
. Modutarsysten consisringof display/.onrrolmodute and tinin9 metlod as vpll as timing seftings
and paeunalic drive utrit -Automalicaliy changes setrings to optinize assBr
. Proprierd.y d.flalion liming manaqemcnl - Proprielary soflwr.e sets timing lo cor.espond to
individual patient needs
ELECTRICAL
Allows user control ofmost pump lunclions
90 264 VAl. -17-l,X H2
. 'Iypical povo consunplion: 245 watls ARIGGER UODES
' Maxrmum powe. cons umltion i 420 walls . ECG (PA'I1I]RN, PEAK, AFIB):
. E.llery operating tim.: Miooprocessor-bas€d R-wavefo.m rigger derecdon
-90 hinlirs ninimun with lull .harge
-180nitrules vith oplional seeord batier, . Pacer {VPACE, APACE):
. Ilpical batteryre.hr.ging limei Low lcvel (sti.) ECC ,nptrt

. IulsF tr rdrh -> u.J ro / o( rnr prlsp dmltrrJde

MECIIANICAL OIMEN5IONS ++2lo +700 mV
. Confol module with monitor: - HigI level (monitor) input
10" high (2S.4.d x 13 75'wide (35.n) r2" deep (5 cm) ' Pulse vidrh 0.1 ro 2ms and pulse amplittrde + 1V
. Pneumalic driv. uniil
'AVpaceldete.rionis<2i0miecberweerpacerprlses
-31.5'high(80o)x:13.5' wide{34.3m)x21'd€ep(53.3cm) . Arlcrial lressure ( I):
MECHANICAL WEIGHT
- Delanlt to 80 bpmj adjuslahle 40 to 120 bpm
5 lbs (2.3 kg)
. ?neuDati( uniiforAuloCAT 2 WAVE.: t Diath€rmy,30 Hz low p{ss

. Toral weighi torAnrocAl'2 wAvE: GENERAL TRIGGER SELECTION CRITERIA

- 100.5lbs (44.71q) (AUTOPILOT MODE)
. Toral weighr lorAERoo series: ECG TRIGGER I,,IOD€S:
91.5lbs (40.7 kg) . PATTERN: HR<130 blmno arrhl,rlmia
HR >130bpn or arhylhmia d€ tecrcd drd
PNEUMATICS anhythmia timing OFF
. Driv€ syslem: Sieppo moto.-driven beuows . AFIB: Any HR with arrhy lhnria detecled'
. D.iv€ gasr UsP-grade hellum . VPACE: Sinsle o. dnal pa.e. (<250 msec aparti and
no QRs or APuavelorm delertcd
-DisposabLe canisler (500 psi) or refillable (2000psi).ylinder- . APACE: Single pacerwith R wave >100 mscc later
US Approval: {2900 psi) cylindcr Enrolean Appro%l TDNirion onlt
APTRIGGER MODEI
-0.5c. ro 50c., sdjusrable in 0.5cc ircrements
.
. Counterpulsation ral€:40 tn 200 pulsations/,linure
No LCG signalornoisy ECG signal

ffi *l l* lFeleflex.
\-w
1",ii#.'i,l,1il
INFLATION/DEFLATION TIM!NG METHOOS
ORDERING INFORMATION
INFLATION TIMING METHODSi
.,4ortic Flow: Pro!rietaryWAVE algorithmseis the timing intra-beaton
IAP.OSOO AJIO'AT 2 WAVE
dletagc 1' ms olaorri.ealve closurer 1 {rA3fl sy em incrudes
. Predictive: AP waleforh .nalJsis ro sel iiflation
Fiber0pnx Sensor Te.htrology
. Weissler: ECC only, inflaridn riming based on systoli.ljne jntervals
wAVE argorithdr Phy5iorogicarry based.
DEFLATION TII,IING M€THOD5: proprierary timin9 rlgorithm
. R-wave: Real-lime deflationon R-wave
adtic ilownmms mdh.d
. Predicriver Dellalion selro occu.jusr priorro next sJsiolic ris€
. W€issle. ECG only. dealation timing based on dGsrolic inrerals AuroP,lor mode of oper.rion
IAP-0535 AEROSeries AdoCAT 2 WAVE

. Use.set inflation and deflation timing in Ope.ato.Mode

INFLAIION/DEFLATION TIMING LIMITS (OPERATOR MODE)

. EC(il Inflation 20% A0olo nfR R iriarv,l
Dcllaiion.30olo 120olu olR R inr..!rl
hiflation, 0-35% of peak systole-peak systolc irterlal
Deflalion, 350/0 75olo oipeak systole-peak systole inteNal
.r\FIBTrigger: Infiation 301o430 ms allerRwav€ trigger evenl
Mode Deflarionon R wavc

. IY!.: Color LCD flat s.recn

. Ch.n n els: Three -chamel multicotor waveforhs
. ECG: Grcen r,cr wirh vhirc hiqhlight or assisted poflion
. AP: Red lrace calibrared for dir€cr.eading ofAg whire
highlight on.ssislerl poriions when in Oper,lo.Mode
. Balloon p.essurq Bluebace calibraledln bh Hg and displayed .onrinuously
. Timing.eferen.e d isplryi Nu mencal timirgsertings in boil operatingmodes as

well as a bar g.apl disptaying intare/deflale eve.ts in Operator Mode

. Cursor: Measlremcnl olAP and balloon lressu.e waleto.ms

ALPHANUMERIC DATA
. Patieli henodynami.s: Hearl rate, AP-sysroli.. augnented, diasrolic. and mean
arleri.l. When in 1:2 or lower assisl ratio the assisred values are disllayed in
white and lhe unassisred lalnps a.e displayed itryellow
. Displayed parameters: ECG source rnd gain state, alarm sraius lvirh dher, ON
Battr.y indication, Dperation modc sclcrrion, AP ala.m pa.amcrer and tjmir,
timing setlilrgs, heliun tanklevel, a.$yrhmi! delection, and liming slatus Nore: Addiuonal synem sp€.if ications are avair.bre
. Operations slatus: Opoarionalmode, t.jggermod., hclium tank garg., rrom Atrow lpon request.
Specif iQriont are subject to chanqe wnhour notice
alarm/bartery chalge statN. balloon volume Caurion: U.S. Feddrarraw rimt5this devicero sate by
. Diagnosric al,rm/hel! messagcs: Prrprogiammed troubleshooting pronpts/help or on order ol a physlcian

SiRIP CHART RECORDER REFEREI'{CE: lSchreuderil, Castiqtioni A, Donerrr A,

. Recoder: etal. Automatic iikaaortic balloon pump !im'09
Dual-chdnnel dol matrix:Dol density 400 dols/in.h, 15
mn/s usinq ai l.t.abeatdicrotic notch rredidion
' Wavelorms:ECG,AP,o.b.ltoonpressure (oneortworecorded) alqorithn Ann fhbto. Surq 20A5:79:101?-1A22
. Atphantmeri.: Orerational mode, uiggerhode, ECG iead/sou..e.AP sour.e,
AP slarn slalus, timing sexings, €ssistratio, balloonvolume. riming
a.rhylhmia status, alarm.ondilion, dale, iime, palient Research I.iangle Park, NC 27709
PhoDe: 366.246.6990 Faxr 300.399 t023
DISPLAY FREEZE
TELEFLEX,COM
. F.eezes approximatlyT se.onds olpatientd.ta on soeen
Ieltrex, AE RO, A(o!r, AutoCAT2 WAVE.AuroPitol,

PATIENTSIGNAL INPUTS FlberOptix and WAVE ar. rademarks or registerod

trad.marks otTeleflex lncorporaled rr hs afliliates
. ECG:5lead skin cable (1,ll,lll. aVR, aVL, aV! andY) @2012 Tel€Ild l^corporated
Higllevel monnor input (0to 5 Y) Arl.ighls reserved. 2012-0310
. AP: l'iber optic siqnal input from lteroptiriAB Cathete. (WAVE)
AP lransducer lspeclramed or equivalent), 50 mv/V/cm H9
Hilrh lelcl nonno.inpul (1V= 100 hmHS)

'lFeleFlex'