ประกวดราคาซื้อวัสดุการแพทย์รังสีร่วมรักษา จำนวน 6 รายการ
โครงการนี้มีวัตถุประสงค์เพื่อจัดซื้อชุดขดลวดสำหรับอุดหลอดเลือดโป่งพองในกะโหลกศีรษะ พร้อมอุปกรณ์ใส่ขดลวด (Concerto Detachable Coil System) และชุดขยายหลอดเลือดด้วยบอลลูน (Peripheral balloon dilatation Conquest) จำนวน 1 ชุด เพื่อใช้ในการรักษาผู้ป่วยที่มีภาวะหลอดเลือดโป่งพองในกะโหลกศีรษะ
ขอบเขตงานประกอบด้วยการจัดหาอุปกรณ์ที่มีคุณสมบัติตามที่กำหนดใน TOR เช่น ขดลวดที่ทำจาก Platinum หรือ Nylon, PGLA, Micro Catheter, Angiographic Catheter และ Introducer sheath เป็นต้น โดยอุปกรณ์ทั้งหมดต้องได้มาตรฐาน CE Mark หรือมาตรฐานอื่นที่เทียบเท่า
ผู้เสนอราคาต้องมีคุณสมบัติตามที่กำหนด และสามารถส่งมอบอุปกรณ์ได้ตามระยะเวลาที่กำหนด เพื่อให้การรักษาผู้ป่วยเป็นไปอย่างมีประสิทธิภาพและปลอดภัย
English summary
This project aims to procure a set of coils for embolization of cerebral aneurysms, including coil delivery devices (Concerto Detachable Coil System) and a balloon dilatation kit (Peripheral balloon dilatation Conquest), totaling 1 set. The objective is to provide effective treatment for patients with cerebral aneurysms.
The scope of work includes supplying equipment that meets the specifications outlined in the TOR, such as coils made of Platinum or Nylon, PGLA, Micro Catheters, Angiographic Catheters, and Introducer sheaths. All equipment must be CE Mark certified or equivalent.
Bidders must meet the specified qualifications and be able to deliver the equipment within the defined timeframe to ensure effective and safe patient treatment.
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ข้อมูลเชิงลึกของโครงการ
AI วิเคราะห์ ปลดล็อกแล้วเป้าหมายโครงการ
- จัดซื้อชุดขดลวดสำหรับอุดหลอดเลือดโป่งพองในกะโหลกศีรษะ พร้อมอุปกรณ์ใส่ขดลวด และชุดขยายหลอดเลือดด้วยบอลลูน เพื่อใช้ในการรักษาผู้ป่วยที่มีภาวะหลอดเลือดโป่งพองในกะโหลกศีรษะ
ขอบเขตของงาน
- จัดหาชุดขดลวดสำหรับอุดหลอดเลือดโป่งพองในกะโหลกศีรษะ พร้อมอุปกรณ์ใส่ขดลวด (Concerto Detachable Coil System) จำนวน 1 ชุด
- จัดหาชุดขยายหลอดเลือดด้วยบอลลูน (Peripheral balloon dilatation Conquest) จำนวน 1 ชุด
- อุปกรณ์ต้องมีคุณสมบัติตามที่กำหนดใน TOR
สิ่งที่ต้องส่งมอบ
- ชุดขดลวดสำหรับอุดหลอดเลือดโป่งพองในกะโหลกศีรษะ พร้อมอุปกรณ์ใส่ขดลวด (Concerto Detachable Coil System) จำนวน 1 ชุด
- ชุดขยายหลอดเลือดด้วยบอลลูน (Peripheral balloon dilatation Conquest) จำนวน 1 ชุด
ระยะเวลาดำเนินการ
- ไม่ได้ระบุ
คุณสมบัติผู้เสนอราคา
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Eligibility Requirements:
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Standards Compliance:
- ผลิตภัณฑ์ต้องได้รับมาตรฐาน CE Mark หรือมาตรฐานอื่นที่เทียบเท่า
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Experience:
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Previous Project Cost:
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Technical Capabilities:
- ไม่ได้ระบุ
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Personnel:
- ไม่ได้ระบุ
เกณฑ์การพิจารณา
- ไม่ได้ระบุ
ข้อกำหนดทางเทคนิค
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Concerto Detachable Coil System:
- วัสดุ: Platinum, Nylon หรือ PGLA
- ขนาด: ตามที่ระบุใน TOR
- Micro Catheter: ขนาด 0.0165 - 0.021 นิ้ว
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Peripheral balloon dilatation Conquest:
- สามารถใช้ร่วมกับ Stents และ Stent grafts ได้
- เหมาะสำหรับ Femoral, Iliac, Renal และ AVF/AV graft
เงื่อนไขสัญญา
- ไม่ได้ระบุ
คำถามที่พบบ่อย (FAQ)
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คำถาม: ชุดขดลวดสำหรับอุดหลอดเลือดโป่งพองในกะโหลกศีรษะ ประกอบด้วยอะไรบ้าง?
คำตอบ: ประกอบด้วย ขดลวดสำหรับอุดหลอดเลือด, อุปกรณ์ใส่ขดลวด (Concerto Detachable Coil System) และชุดขยายหลอดเลือดด้วยบอลลูน (Peripheral balloon dilatation Conquest)-
คำถาม: วัสดุที่ใช้ทำขดลวดอุดหลอดเลือดคืออะไร?
คำตอบ: วัสดุที่ใช้คือ Platinum, Nylon หรือ PGLA -
คำถาม: อุปกรณ์นี้มีมาตรฐานอะไร?
คำตอบ: ต้องมีมาตรฐาน CE Mark หรือมาตรฐานอื่นที่เทียบเท่า -
คำถาม: Micro Catheter ที่ใช้มีขนาดเท่าไหร่?
คำตอบ: ขนาด 0.0165 - 0.021 นิ้ว -
คำถาม: ชุดขยายหลอดเลือดด้วยบอลลูน เหมาะกับการใช้งานแบบใด?
คำตอบ: เหมาะสำหรับ Femoral, Iliac, Renal และ AVF/AV graft -
คำถาม: คุณสมบัติของ Introducer sheath เป็นอย่างไร
คำตอบ: ต้องมีขนาด 6-8 Fr -
คำถาม: ขนาดของ Guide wire ที่ใช้คืออะไร?
คำตอบ: ขนาด 0.035 นิ้ว -
คำถาม: Rated Burst Pressure (RBP) ของอุปกรณ์เป็นเท่าไร
คำตอบ: 20-30 atmosphere -
คำถาม: Working length ของอุปกรณ์เป็นเท่าไร
คำตอบ: 50 , 75 และ 120 เซนติเมตร -
คำถาม: ทำไมต้องมี Radiopaque marker
คำตอบ: เพื่อให้สามารถมองเห็นอุปกรณ์ได้ชัดเจนภายใต้การตรวจด้วยรังสี
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3.6 IXe:i~m 'U e:Jn6111'\lliJ~~e:ifLJ1e:i~S1t~e:ie:in Llil ti~1i!m1'Uriru~ m1lJm 1m'Vl 11bb~~t1 1 m~V111~ 3.5 bU'U~~ ~nru6V'1~ vl'fLJ1e:i~rirum'Wmm~1'U:u 1n e:i~l°im 1m'\1111bb~ m CE Mark ' ... '
3. 4 e:itJ n 1ru 1~~1tJm f 'U 1e:i~ ~'U fi'1 :u 1n~1i!m1'\.J ri ru~ m 1lJ m 1en'Vl11 bb'1 ~ m 3.3 611m1mb'1m tJ~ti'U'LJ'U11il bb'1~m1lJm1~1lJri11lJIXe:i~ 11 'U 'LJ eN'Vl 'l..bti~1'U1~ bb'1n btJ~titJA'U'U~,;Yl 1~1ilti ~ IXe:i~ b~tiri11 i~ 1 ti b ~lJ
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3.2 '\111f1~~~nru6V'l~Vl1~'U~,;Vl i ?i~lJe:J'U ~1Vl ~'\ll °Ll 1 tJ~1 'U f~~~1lJf n~11 m~'\lllJlil'\111€l'VllJ\il €l1 tJ611m 3.1 l1entim11-ti~1tJhJi.Jmm11 2 ll i!LJ:u1nl'tJ~?i~~tJfi'1 '
3. b~B'IJ1"ll mrn~
b~'U~1Pl'UEJf1'11~f111lJtJ111l~1tJ ~
2.6 'U 11:u e:i ~Jl 1"/l'U ~'LJ 'U 1li1n1~~ lil f lil bb'1~vh1~tJ11Pl:U1 m e:i (Ste rili zation) bb'1 ~'U e:i nl''U '\lllJ li1 e:i1 tJ ' ~ ' 2.5 l1'LJ'U11i1~1~ 11~b~e:in1i~1lJri11lJIXe:i~m1 ~~ bb ~ 4 -11Fr.m1lJtJ117,10 bb'1~ 25 61llJ . 2.4 l1mliltl1V11~b~e:itl1vim~m~e:ilil (mini gu idewire)
1~~1tlbb'U'U Snap on dilator lock
bb'1~bb 'U'U61UVln'U tJ m ti'LJe:i~~Vl '1 li1 m1v\'1m ti~ i!~'V1 '1 €l li1 b~e:Jlil 611m1m1e:i rin'U~Vl 1~m.ltJ bb~U'1\il~e:i ri 2.3 11il bm ~e:i{ "1lUliltJmm~tJ1tJ11 (Long typer) -d ti f111bbV1~~1'U~1'\lliY~~'\11'1€llilb~e:Jli11~~'U61~1i11n
?i1tJ 1ritJ 61~mmb'1~,Je:i~ntJm1lJ~lil'W'111i11tJ m1 e:i 1i
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bb'1~mliltl1~1'U 1~61~mn ,Je:i~ntJm11 'Vl'1n~'U'LJe:J~ b~e:ilil 1~~ l1~ b'1~1'11 b'1'LJ1~'U'LJ'U11il'LJB~~Vl'U~nru
2.2 l1111M1e:i~nm~ e:ilil 1 'Vl'1EJ€l'Uf1~'U (Haemostasis v alv e) 1fUlil~bf"1~ e:ie:imb 'U'U 1 ~f11161€lli1611tJ611'U '
"111~(Sidearm) 'LJ'U11il 1 'Vlru ,, -d 1ti'1 1ilf111Blill'i' . tJ'LJe:i ~~lJ b~e:Jlil 1 tJvie:i61e:ili1611 tim1i1tl1 61~1i11n ~e:im1bn'U
me:iti1~ b'1e:Jlil bb'1~f111f11'Uf1lJ bb 1~\il'U
CV I .::!i V
v\'11~\nlilm11~ri1mfie:i~ ~mdm~e:i ue:iti~ ~lil (Bio compatability) bb~~ l1ri11lJglil'\ll~'U~~ l1vie:i 2.1 B'ULV11~1b61le:J{ ~Vl ~~~:u1nl'61~ ETFE (ethyle n e tetrafluoroethylene) 6/t~l1f1tu61lJD 1'Uf111
2. flru6ln~ru~mvn~ •
•
m1v\' 1f~~~1lJ~n~1 (Intervent ion) blil til11~ mh~ 61 f11 tJm11i~1'U1~e:i~ ~tJ'1e:Jli1JltJ bb'1~U1~'\l!Vlil b 1m
b~e:ilil b~e:i 1 .ut tJm11ih11:rtJ bb'1 ~
b~e:ilil bblil~ b ~e:i61e:i\i161 1timliltl1 b "111?i'\11'1€l\il ~
~
1-rrbb Vl~ ~1'U~1'\llir~ b "111?i'\11'1€l\il 1. fJW6l'n~ru~~1 hl
vie:itl1611tJ 61 l'U'\11'1€lVlb~ew1 (Intro ducer sheath)
•
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1
( ""'v "" "' ') • ~ rr " . 'U1CJ€l~'U 1'VI f"11 1~'U ('U1CJf"l.fl1~ 'LJ'U~CJ1 'U1 '1 f"l ) ('U1'1?111€l~':il'U1 b 'LJCJ1fl1) ' ' ' ' 0 ""'
'U1 CJ bb 'V-l'VI CJ"l11'U1 '1J fl11 'V>j CJ1'U1'1l"l11"11Y-l'll1'U 1 t1J fl11 ' 0
'U1 CJ bb 'V-l 'VICJ"l11'U1'1J m wi bf"l'!j
Push/ Pull Control '1i1CJ1 Vl?1 1111'1f'11'Uf'111Vlf"l'Vl1'1~1'U UmCJ'LJeJ'l?l1CJ?l1'U1ii'b U'UeJ~1'1~
1 'VI 1 -:i (Sofia Plus Aspiration Catheter) ii 1:1 0
11 VI ?11 CJ ?11'U'U0
Braid and Coil Reinforcement 'Vl
2.4.2 m1u.:ifi'uVif"l'Vl1'1~~ (1:1 Pushability): il1CJ f'1 1'1?1 1'1'LJeJ'l?l1 CJ ?l1'U~1'U 'U~il Hybrid (Excellent Torque) ~vinm 1 'Ufl11vl1~~'1fl11
m1~ n'VI eJ'LJeJ 'l'LJ V1 ~1 V1 (Braid) '1i1m~11tJ1~~'Vli5.fl 1'V-l 1 'U m1 b -LJ'1Ci.:i'Vl~e:ivi b~ e:ivi~il rn111flvi b~ CJ1~ bf"l'!j 1il~1CJ 2.4.1 fl11f'11'Ufl11'11CJ?l1'Utl1'Vl1'1~~ (Torqueability): il1CJ 1m.:i?l~1'1'LJeJ'l?l1CJ?l1'U~1'U mCJ~bU'U lf'1 1'1?1~1.:J\91.:id
Cerebral Artery) bb~~b~m~iJf'11111CJ1TWbf"l'lj ?11111 1tltl1'V11.:i1ilei.:i'Vl~eJ~b~eJV1~1'UUmCJ Ml, M2 il1CJ ?11 CJ ?11 'U 'Vl~eJ~ b~eJ ~'LJ'U1 vi b~ n (Microcatheter) ~'U 1tJ~.:iu~b1 ru'Vl~ e:i vi b~ e:ivi ?111e:i.:i~1'U nm.:i (Middle t11'Vl1 '1 bb~~fl11~vim11'V11'1'Vl~eJ~b~eJV1~~ (Excellent Navigation and Trackability) v111Vl?111111tltl1Y-l1 2.4 bU'U?l1CJ?l1'Utl1'V11'1'Vi~eJvib~eJvi?l11e:i.:i (Sofia Plus Aspiration Catheter) ~:iJ11ru?111u~~bf"l'!j'LJeJ'lfl11
29% 'LJeJ.:i~ tJ mru~:iJ'LJ'U1vi 0.060" Tapered Catheter
(More Aspiration Power) ?1 .:i n11 23% 'LJeJ.:JeJtJmru ~:iJ'LJ'U1V1 0.064" Tapered Catheter bb~~?l.:in11 " ' " 'LJ'U 1vi 0.070 D1 (6F) iJ1 CJ'LJ'U 1vi b'1'U~1f"l'Utln~1.:i~1 'U mu
v n11e:itJmru5'U 'I v\'11 Vl:iJ bb 1.:i\9i''U 1 'U m1vivi~m~e:ivi 'U
2.3 bU'U?l1CJ?l1 'U tl1'V11'1'Vl~eJV1 ~eJV1?111eJ'I (Sofia Plus Aspiration Catheter) ~:iJb'1'U~1~'Utln~1'1.fl1CJ1'U
bb~ 11~b11CJ'l'LJ'U
~ ~ ~
Aspiration Catheter) ?111111'1tl1'V11'1bb~ ~ b?l~l.lelU m ru1 'U m1-rn 'lj15'U j 1 'U'Vl~eJvi b~eJvi~flvi b~CJ11il~1CJ 'LJeJ'l'Vl~eJ~b~eJ~nr'UI (Steam Shapeable) '1i1CJ1Vf ?11 CJ ?11'U'U 1'Vl1'1'Vi~eJvib~eJvi?l11e:i.:i (Sofia Plus 2.2 ~1'UU~ 1 CJ'LJ e:i.:i ?11 CJ?l1'Uil '1n'ljru~~1-:i (Straight) bb~~?11111 tltl 1111\9i'vitJm CJ 1 VI b 'Vl111 ~?111nu m CJl.fl 1f'1 fl11b .LJ1Ci.:i'Vl~eJvib~ eJ vi~:Wm1 11f'1 V1 ~CJ1~ bf"l'lj 1il~1CJ (Excellent Navigation) ~vinm 1 'Ufl11vl1~~ tlfl11
U11 bb~~:iJ fl1111~Vl'Vl~'U?l'I (Flexible) ~Vlf'11111 ~CJ'l'LJeJ 'lfl11~n.:ie:i (Kink Resistance) b~11UW~'Vl5.fl1'V-l1'U ' ' "
(Braid) 1'Ut:Ji!.:i-&'U1'U (Inner Layer) :iJm'H?l~11 Coil Reinforce vh1Vl~1'UUm CJ 'LJeJ'l?l1CJ?l1'U :Wrn111~eJ'U ~1'U~'UtJ1~ne:iuil1CJ Hybrid Braid & Coil Design bb~~~1'U ~1 CJ ?l1CJ?l1'Ub 'Ufl11~n'VleJ'LJeJ'l'LJvi~1vi 2.1 b U'U?l1CJ?l1'Ut1'1'Vl1'1'Vl~eJV1 ~eJV1 ?1 11eJ'I (Sofia Plus Aspiration Catheter) ~:iJ1f'11.:J?1~1.:i'LJeJ 'l ?l1 CJ?l1'U
2. riru 6in~ru~bU'V'l ~
Aspiration Catheter 6'! Vl -r'U V1 V1~ 1lb~ eJvi 1 'Um1-rn'lj1 hfl'Vl~eJV1b~eJvi?111e:i.:ie:iV1 'U (lschemic Stroke) " ' '
1il ~ 1 CJ ?1°1'\ll -rum 1 -r n 'lj1 b fl 'Vl ~ e:i ~ e:i vi ?1 11 e:i .:i ( Neurovascular Disease) bb ~ ~ :iJ fl ru ?111 u~1 off b ti 'U e:i ~1.:iiltJ ~~'Vli5 'V-l bb ~~u~nru~ 'U tJm CJ :iJ f1 1111 i.1 11 ~bf"l'lj '1i1 CJt11'V11.:i b oLJ1'Vl~ eJVl b~e:ivi'LJ'U1vi b~ n~1'U tJ~1CJ ' b ll 'U ?11CJ?11'Ut11'V1 1.:i'Vl ~ e:i Vl b~ e:iV1m.J "ll'LlV1 t.b.J ~ f"l~~il rn 111 bb ~.:i bb 1-:i ·1h CJ 1 Vlm11~e:iu mru5'U., 1'Un11 -rn~1 ' ' I
i.ri ru6in~ru~..t1 hi
(Sofia Plus Aspirat ion Catheter)
6'11 £J6'1 'Ut11'Vl1~ 'Vi &l eJ~ b~ eJ ~6'1:1.JeJ ~"ll'iJ ~~11 bb&l £J1T~ bfl~ri 1'Vi~'U~ ~~ 11b~el~1 'U6'111eJ~
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('U1'1?111e1'1"i!'U1 b~tJ1r\'1) ~
'UltJbb Y1'VltJ'lJ1'U1 t1jfl1'j ('UltJl"l.fl~'U~ tJ~'I ) ' ' ' ' 0
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3.5 b U'U~~~Ji'rusvivtl~-r'lJ'jeJ'lf'lru.flTV'jiJ1m'51'U"il1flB'IA fl1'jeJ1V! 1'jbb'1~ tJ 1 CE Mark '
3 . 4 BtJ mru 1~~1'U fl1'j-r'lJ 'jeJ'l~'Ul°i'1"il1fl~1i1rn1'U f'l ru~ fld'jiJ fl1 'j eJ 1V!1d bb'1 ~ m 3 . 3 ?!1iJl'jflbb'1fl b tJ~ tJ'U'lJ'U1~bb'1~f'l11iltJ11~1ilf'l11i!l'i' 'lfl1 'j 1 i'l1'U'lJB'IVl1J1tJ'11'U1~
?11mdt1 bb'1mtJ~tJ'UA'U'U~,jvi1~~tJ 1~1'i'B'lb~tJri11 1tJ b ~ii
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3.2 Vl1fl~~~Ji'rusvi~vi1'l'U~,;vi, ?i'liJB'Ubb~1Yl1'1VlL11tJ'l1'U-r'l ~~1ii-rmn 1-ffl~VliJ~Vl~BV!iJ~mtJ 3.1 iJmtJfl1'j1i'l1'U 1~tJBtJfl11 2 U 'l!'U"il1fll'U~?i'l~'Ul°i'1 '
iJfl1'jeJ~l'i''U (M 1/M2 Occlusion) ' 3. biei 'Whmwn~
'li1tJ1~?!1iJ1'jfl;'U1 tJfi'IVl'1B~ b~B~?! iJ B'l?il'UU'11tJ (Distal Vessel) Vl~B'U~bl ru?i1'UtJm tJ'lJB'IV!'1B~b~B~ ~ 2.5.2 ?!1tJ?!l'Uil1Yl1'1Vl'1 ~b~B~?!iJB'I (Sofia Plus Aspiration Cat heter) f'l11iltJ11 131 61Jil . ~tJmrumfl~ilb~B~ 1 'Ll?!iJB'I (Retrieval Device)
b ~ B fl 1'j b~ B fl 1 i?11 tJ?!1 'UV!'1 B~ b~ B~'ll'U 1~ b~ fl 1~ Vl'11 fl 'Vl '11tJf'l 1 1iltJ11 ?!°1V!-r'U fl1'jYl 1~~fl fl1 'j~ il rl'U 2.5.1 ?!1tJ?!l'Uil1Yl '1Vl'1 ~B~?!iJB'I (Sofia Plus Aspiration Catheter) f'l11iltJ11 125 61Jil . (Distal OD) 'll'U1~ 0.0815"/ 2.l mm iim1iitJ111~ ~Bfll'l1 ilf'l11ilb'Vlill~?!il'lJB'l'jeJtJhf'l ~'Id 'U~nru?i1'Ul'i''U (Proximal OD) 'll'U1~ 0.0825" I 2. l mm bb '1~b61'U~11"1'Utlflm'l.fl1tJ'UBfl'U~blru?i1'U tJmtJ 'IJ 2.5 bll'U?!1tJ?!l'UU Yl1'1Vl'1B~b~B~ ?! iJB'I (Sofia Plus Aspiration Catheter) ~iJb61'UeJ1~'Utlflm'I .fl1tJ'UBfl
?i1'UtJmtJ~iJm1iif'l b~ tJl 1~ l~tJ 1~iifl1Ti'.frl'IB'lJB'l ?! 1tJ?!l'U
Reinforce v1' 11 ~?il'UU'11 tJ'lJB'l?!1 tJ ?!l'U iJ m1iiei B'ULl mbm iJ m 1ii ~ ~Vl~'U?! 'I ?11mdm-U1fi'l'Vl'1 B~ b~ B ~ ' ' 'IJ
2.4.3 f'l11ilbb~·Hb'j'lfHYl'U (Kink Resistance): tJ lf'l'j'l?\~1'1'lJB'l?!1tJ?!l'U~iJfl1'jb?!~ii Coil
'U1 tlbb 'WVl tJ-d'1'U111J f111oW bPI~ 'U1 tlbb 'W V1 tJ '1l' 1 'U111J fn 'a 'W CJ1 'U1 rt 'IJ1 'W -d' 'U1 11J fn'a ' ' ' ('U1-:i?1115ff'ilm b~ l°\'1 )
/ ~ ('U1CJB ~'U1Vl Pl~~(Jl tJ) ('U1CJl"l.fld~ oLJ'U(J)CJ1'Ul'lPl)
Hook Catheter ~'Ll I \?11 1Jfl111J~B'lf11"J"lJB'l eJli
Catheter, J curve Catheter , Multipurpose Catheter, Renal Catheter Shepherd 1icl1V!~'U'Vl6'1BV1b~BV11'Ll-dei-:iein'Vl~B-1iei-:iVfei-:i ( Viseral use ) Cobra Catheter, Yashiro Catheter ~'Ll I ~11Jl°n11J~B'lf111"lJB'leJli
Catheter, Headhunter Catheter , Mani Catheter, Verterbral Catheter, Newton
• 1icl1V!-r'U'Vl6'1BV1b~BV11'Ll?f1JB'l ( Celebral use ) Simmon I Catheter, Simmon II "
2.7 iJ'Vlmn'Vlmm '\Jb b'U'U1~b~ei 1i
. "
"ll'Ll1V1fl111Jt111 bb 6'1~"ll 'Ll 1V1mV1il1~?11m111?11m -ir11~
2.6 bll'Ll'll'DV1 Hub 1?t ?11m111m1-:v?tei'Uyjei-:imml"11~~1 CJ bb 6'1 ~1~'U"ll'Ll1Vlb~'Ll~11"1'Lltlnm-:in1 CJ 'UBn
bu'W 1 ~"IJ'Ll n6'11 .:J"ll ei.:i?t 1CJ?f1'Ll'Vl6'1eiV1b6'1BV1bVl1'Ll'Ll
2.s iJ~'U~1n 1 CJ'Ueim~CJ'Ubb6'1~~'U bb\918-:i fl-:i~n~1mTVi'U bb?t-:i-r-:i m l'b ll'Uei~1-:i ~ lVl CJ~?11J?11-a-Vi'U~-:i~H v v Q.J .::!ii I Q.J
(Sythetic elastomers meterial)
2.4 b llu'll'DV1 fl.:J"J'\J 'U b~1J hJb tJ~ CJ'Ubb'IJ6'1.:i bbW 'UBtu'Vl.fliJ"1J 'I 'U ei.:i~1.:i CJ ~1 CJfltu?f1JD~Yl 'I bl"l~"lJB 'l l?f Vlvtl , i~~~
BB nbb 'U'U1J1b ll'LlYlbl"l~bb!;l ~tJ mCJ1J'Ll Round Tip -d1 CJ !;'lVl m1'Vl1m CJ U'l'Vl!;lBVl b~BV1
2.3 ~1'LlDmCJ"lJB'l?f1CJ?fl'U'Vl!;lf:lV1b~BV1 bll'Ll'll'DV1~'Llbb!;1~ 8~m ~'U (Flixible Smooth Tip)
(Torque Control) 1~m1J~B'lf111bb!;l~?f11J11t1Vl'Ubb "J'l vl'Ll ~Ci.:i 1000 DB'Llvl B~111-:iD1
• •
2.2 i11fl-a.:J?1{1-:ib ll'LlmVl?fbb~'Ub!;l?f Stainless steel mesh 1 fltu?f1J'U1i1 'Uf111fll'Ufl1Jf11TUV1 ?f~V11n~ein11?11'U~11J!;11V1U 1~'Vl!;l1CJ"ll'Ll1V1
2.1 b tl'U?f1 CJ?fl'U'Vl!;lBVl b~BV1'1J'DV1~U'l'U1'1Ylbl"l~ (U l tra-thinwall) b ~1Jm11 'Vl!;l"lJB'l?f11Vi'U-r-:i~ bb!;l~ 2. F1ru~n ~ru~bow1~ •
m11i-:i1'Ll1~mh.:i'\J !;1BV1Jlmb!;l~'\J1~V18V1b1m
•
tJ m tl"ll B.:J?f 1 CJ ?fl'Ll m1J ~ 1 bb V!U.:J~ ~ei.:i m-a1\J-:v5CJ bb!;l ~ m1'Vl 1~.:i~ ~1 1J ~ n'N1 (I nte rve ntio n) bVl CJiJ1 ~11'\J "J~?f 'l flb 'Ll 1 ib th.i?11CJ?11m .U11 tJ1 'U'Vl!;1BV1b~BV1~ ~1 bb 'Vl'l.k ~~ei.:im 11~?1~V11 n 1 icl1w~\. 5V1?11-a-Vi'U-r.:i 1'U " 1. Firu~n ~ru~~11tl •
• 6'11t16'11'U'Vl6'1e:J~b~e:J~ ANGIOGRAPHIC CATHETER
"" ., -a1t16'1~beit1~Firu6'1n~ru~
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'LI1 CJ bb Y'lVl CJ'll1'LI 1 qJ fl11Y'l bf'l~ ' 0 ""'
('LI1tJeJ~'LI1Vl f'1~-r\91tl) v--
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?l1Li11flJ?l'lJ
3.6
~e:i~m u be:J fl ?J11vitl'~~e:i1' 1e:i~~~e:ie:ifl 1vitJ61 tl'rn 'Uflru~m1iJm1mvi11bb!;l~tJ1 m~YJ11~ b ll'LI~~ \91Jl ru sv1ffilil1'u1e:i~ flru.n 1Y'lm \911 ~1'LI ~ 1 fle:i fi' m1e:i1vi11 bb!;l ~ m CE Mark ' ...
3.5
mJ mru '1\il ~Tum 1fo 1e:i~~ 'LI f\'1~1fl611 -J rn1'LI flru~ m1iJ m 1mvi11 bb!;l ~m '
3.4
3.3
?J1m1ri bb!;l fl b tl~ tJ'LI'll'LI 1vi bb!;l ~ m1iJ m1 m iJ fl 1iJ~ e:i ~ m11-if~1'LI'llm viu1tJ~1'LI 1\il
?J1iJ1'rn bb!;l fl b tl~tJ'LI~'Liu~~Yl 1mvitJ 1lJ~e:i~ b~tJ~ 1 -if ~1 tJ b~iJ
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3.2 Vl1 fl~~ \91Jlillsvl~Yl1~tJ~~Yl '1 ~~iJe:JtJ 1Yl1 wJ1m1'LI1~~11iJ1fl~1 1 mlJV1iJV1V11eJVliJVle:i1 tJ
iJentJfl1'~1-il'~1'Lihh!e:itJn-J1 2 tJ tl'u~1 fl i''LI ~~~'Llfi'1 '
3.1
3. b~eiu lozJborn~
"MJ1'\J1'11'lll:S'V'l-lil'U1t\Jfl1'j ' . ~
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('U1CJB 'Ul'Vl f"l~11'1LJ) ('U1-:l?f11eJff'il'U1 b~CJ1rll )
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b U'Ue.J~ l'lnru6Vl.ffi~r'\J-av-:iflru.n1~mm~l'U:Ul flB-:lflfll'aBl'V!l'abb'1~ CJ1 CE Ma rk . "'
3.6
19i'v-:iffi 'U bvfl?11-avtu-:i~vr'U-av-:i;-:ivvfl 1vi CJ?f 1um1'Uflru~m-a11 m-amvt1-abb'1~m m~'Vl-a-1-:i
3.5
•
v'IJ mru '1~ ~1'U m-ar'U -av-:i ~'U A'1 :u1 fl?f Tu fl-:l l'U flru~ m-a-11 m-amvt1-a bb'1 ~ m
3.4
3.3
?11m-at1 bb'1 fl b 'IJ~CJ'U"LJ'Ull'l bb'1~m111m1m11fl1Twl9i'v-:i m-a 1.ff-:i1 'U 61Jv-:ivtt11CJ-:i1 'U1~
?11m-at1 bb'1 fl b 'IJ~ CJ'U~'U'\J~,;'Vl 1~viCJ 1li 19i'v-:i b~CJfi11 .ff~1m ~11
•
3.2 Vil fl~~ l'lJl ru6i'l~'Vll-:l'\J~,;'Vl '1 ?f -:llJB'\J bb~l'Vl 1-:l'V!Ul CJ-:ll'Ur-:i~'i111 rfl~l 1 ibJvt11 vivt'1Bvt1J vi Bl CJ
i1mCJm-a1.ff-:i1'Uhii.JvCJffi1 2 tJ u'\J:u1n-)'U~?i-:i~'UA1 •
3.1
3. b~ 'W 6llbU'Vn:::
2.8 '\J'a'a:U '1 vi'11~'\.Jilf"l:Ulnb~B1viCJ nl"llbB5~~'UBBfl 1611~ •
2.7 ffi~b~B fl'll'Llvi'IJmCJ m-:i,1A'-:i
2.6 i1m111 m1~-:ibb~ 150, 260 b"ll'U~blll'li
2.5 i1"1l'U1Vl b~'U~lf"l'Utlflm-:l.f11CJ'UBfl OD ~-:lbb~ 0.025" ' 0.032" '0.035" ' 0.038" 'Ll1 v "
v v
v111 '1 vim-av11mCJe..iu-:ivt'1 BVI b~BV161Jru~ 1 .ff-:i1'U
2.4 ?i1'U'IJm CJ61JB-:l'11V1UlblJ'U"l1'Llvii1fl1111~vivt~'U Flexible Tip bb'1~'1JmCJ~'IJ11'U Rounded Shape "
1~~1vi CJ fl-avivt'1vv11mCJe..iu-:ivt'1Bl'l b~BV1 '1Vlfllibnl'l Vessel trauma bb'1~ Thrombus
flru?111 'U°i~ bf"l~61Jru~blJCJfl~'U 1~fl1111~'Ubb'1~?f~mfl61Jru~?fvvi:u~1vt'1 b-LJ'11 '1Jm11vt'1B l'lb ~Bvi •
2.3 ~'U~l~l'U'U Bfl61JB-:l'11Vltll b1CJ'U bfl~ B'\J~l CJ?fl'a 1®"Vlbl'l'a~~ fl 1 ~~ blrn{ (M Coat ed) ij
l'lllJl'lB-:l fll'al'lB-:l fll'a
.., ..,
fll'a ~flvt'1B~'\J 1~~ (Ki nk Resistance) bb'1 ~?11m -at1m'\J~llfll"atlvi (Torque Control) 1~ 2.2 bbfl'Ll1'Ll"LJB-:l'11VltllbU'U"l1'Llvi Super-elastic alloy core i1~ru?111u~~bf"l~1'UflliDB-:ln'U
2.1 blJ'U"ll'Llvi Plastic-type wire 61i1CJ'1Vl fll'avll'11CJe.JU-:l'V!'1Bl'lb~BV1
2. flruan~ru:::mvn::: •
ll'lti'IJ'a~?f-:lfl1'Ufll"a1.ff-:i1'U1~B~l-:l'IJ'1BV1JlCJbb'1~ 'IJ-a~WJl'lb1'11 •
?flCJ?fl'U (Catheter) vt '1Bl'lb~Bl'lb.;iB1m'Llm-a1'Ll:u5CJ bb'1~m-avhr-:i~1111rrn~1(Intervention)1viCJi1 1.ff dJ'U~'\.Jmrutl11 'Ufll'a?fBVlb oLJl'V!'1BVlb~BVl h.J~v-)CJ1:::?i1'U~l-:l 1 61JB-:l'ilCJfl1CJ 1~?t:::\111fl 1.ff?f1vtr'\J tl1 1. fl ru an'rJru:::~11t1 •
?11CJffWltl1?! 1vtr'\J?f l CJ?f1'U~1 h bb'1 :::vt'1 eWl b~ B Vl'll'Llvi bfl~ B'\J~l CJ ?fl 'a Hyd roph i Lie
"" .., -a1E.J :::b E.Jvi~ ruam~ru:::
4
'Y'ltJ1'U1'1l'1J1~'Y'l'111'W1qjf11'j ('W1'16111eJ'1"il'W1 b~tJ1rl1 )
Q)vV
'U1tlbb 'Y'lVl~'81'U1qj f11'j ' ' '
('U1tJP1.fl1~ oLJ'Ul'ltJ1'U1'1Pl)
'U1tJ bb 'Y'lVl tJ'1J1'U 1 qJ f11 d'Y'l bl"l~ ' 0 ""
('W1tJel~'W1Vl P1~1'1'1tJ) ,/'
'
61151jnJ61'LJ
3. 6 t'l el-:iffi rnel n611jvt1J'-:i~el1'ud el'I~ -:iel el n 1~ t1~111' rn1'U i'1 ru~ nJjl.J f11'jtJ1Vf 1'j bb'1 ~ tn m~vid1-:i 3.5 bU'Ue.J~l'lnru6Vlvhvi'fodel'li'1rum'Y'lmm\i1mnnel-:ir1rndmVl1db '1~t11 CE Mark ' ""
3. 4 tJ mru "lvi'cJ 1'U rn d1'u jel-:J~'W A1"il1 n~111' n-:i1'U i'1 ru~ nJ'jl.J f11'j mV!1'j b'1~ti1 3.3 611l.J1'jmb6'ln b tl~ tJ'U'LJ'U1~ bb'1~i'111l.ltn11'11l.JA11l.ll'lel-:irnd 1i-:11'U'llel'IV1°Ll1t1-:i1'U1vi'
611l.J1'jti bb'1m tl~ti'W~'Uu~,;'vi 1m~ ti 11.il'l ei-:ib~t1fi1 H~1m~ll
'
3.2 V!1n e.J ~l'!Jl ru6Vi°~Vl1'1'U~,;'Vl i ?f-:il.l el'Ubb'11Vl1'1V!tl1tJ'l1'W1''1~~1l.l1'n~1 1 ml.JV!l.JVJV!~elV!l.J~ el1tJ 3.1 iimt1rnjtoff-:J1'U h.it'.feltiffJ1 2 lJ 11'ulil1n1'U~?i-:i~'UA1 •
3. b~ei'l..!hnu vn::
" 2.6 'Uel'1~'Wii Rated Burst Pressure (RBP) ~'lbb~ 20-30 atmosphere
" A11l.JtJ11 ~'lbb\11° 20-80 l.Jl.J.
b61'Ue.J1~'Wtinm-:il'l-:i bbl'! 5-12 l.ll.l.
" I
I.I I ' V
2.5 'Uel'1~'Wii'LJ'W1V1 ~1-:111~611l.J1'jm~eln1off-:11'U1vi'~-:id
2.4 611t1611'W'Uel'1~'Wiim1l.lt111 (Working length) 1 ~b~ei n 3 'll'W1~ 1vi'bbn so , 7 s bb'1~ 120 "lfl.l. 611tJ611'Ub-if1Vl'1elVlb~elV1 (Introducer sheath) 'LJ'W1~~'1bb~ 6-8 bvlj'W"1i' ~'Wtl~tl'U'LJ'U1~'llel'l'Uel'1~'W 2.3 611l.J1'j()H1vi'nu'11Vl~1t.h (Guide wire) 'LJ'U1Vl 0.035 D1 (0.89 i3'1~bl.Jl'Jj) bb'1~ 611l.J1 'j(11-&1vi'nuvim11
'
2 "ilVJ ~?i1'Wl'l'Wbb'1~?i1'Utlmti
'llel'l'Uel'1'1'U \I b ~ el°1i1t11 'Wf11'j11'11'11bb vi-J-:iu el'1'1'U \I 1vi'el~1-:itinl'lel-:im.i'U~1 \I
2.2 ii~1~1'11bbV!tl'I Radiopaque marker ~l.ltl'lb~'U1vi''llru~ci1t1m'Y'lbeln"/fbj~
2.1 'Uel'1~'Wb U'Ubb'U'U Non-compliant , Low profile
2. i'1ru~n~ru ::b Yn:: •
dilatation)
?i1'Utlmt1V!~'l"il1nf11'1bb'11 b ~ei 1 ~ Sten ts , Stent grafts bb'W'U~vinue..i11'-:ivt'1elV1 b~el~~ ~'l ~'U (Post 1.2 b U'U611tJ611'U~iiuel'1'1'U~tlm tJ611tJ 1-ff b ~elf11'jci1'1'lltJ1tJ Stents , Stent grafts 1 'W'U~b1 ru V! '1 elV1 b~el~ bb 'I \I AVF,AV graft) ~~'U~'W1vi'
~'U 1\1lmovn~ 1 'W1'11bbV!tl'I Femoral, Iliac, Renal bb'1~ 611l.J1jti 1offb~elf11'j'LJtJ1m~'Ub~el vi '11vi1'uviein 11'1 (
1.1 b U'U611tJ611'W~iiuel'1'1'U~tlmti611tJ 1 off b ~el f11'j'LJtntJV!'1 el\11 b~el~ bb~'I '11vi1'urnd1'm~n 1 'jf1V!'1el\11 b~el~ bb\11'1 \I 1. i'1ru~n~ru::~ hl •
611tJ611'Ub ~el'LJtJ1tJV!'1 £J\1lb~el\11 bb~-:i?i1'Wtlmt1vi'1 tJ'U£J'1~'U (Peripheral balloon dilatation Conquest) "" ., ~1ti 6'1 :: beJ ti \1lfl ruG'l n~ru::
!5
G
°ll~6'l1~'V'l~B1l fltlmuhhv1-ru t161m.1 "llij~ tJ6'l~1~ (Concerto Detachable Coil System)
"IJ\11'11\11 f)~'UDD m.J11~ Vl1f1hJ?i1m1i:rn:i1 'U~1bb Viti-!!~ bVl1J1~?llJriD'Uf11TU~BEJ"IJ\1lffd\11
2. flru~m,H1J~b\:d'\Al1~
'
1.1.bll'U"ll\1l ffd\1l~vl 1\11f1 Platinum ~lJ~1m~tJ1tJ~vl1\11f1 Nylon Vl~D PGLA (Poly Lactic co
Glycolic Acid) or Lactic co-Glycolic Acid)
1.2. b~eiv\'1 m1'\.J~eitJ "ll\11'11\11\l~:W~n't'fru~bll mn~m (Helix) i1"1J'U1\1lb~'U~1'UPi'Utlmn-:i~-:i bb~ 2, 3, '\/ ,,
4, 5, 6 7, 8, 9, 10, 12, 14, 16, 18 bb"1~ 20 iJi;:ifalJ\911 bb"1~:Wm1lJm1~-:ibb~ 4, 6, 8, 10, 15,
20, 30, 40 bb"1~ 50 b6/f'U~blJ\911
1.3.?l1m1 t11m~n'U Micro Catheter ~:Wb~'U~1'UPitJtlnm-:ifl1tJ1tJ"ll'U1\11 0.0165 - 0.021 D1 '\/
1.4. :W1~'U'Ufll'U fllJf111'1J~BtJ"ll\11"11\11 b tl'Ubb'U'U ni;:i 1n (Mechanism) rieitJm1'1J~BtJ"IJ\11"11\11 ?l11111t:l~-!I '
n~'Uei eirnn 1~ V11nhJ?i1m1m1-:i1 tJil1bb V1ti-:i~b VllJ ~?llJ
mmw bb"1 n b 'IJ~ tJ'U~'U'U~~'Vl 1~\11tJ1~~ei-:ib~tJ~ 11 -il~1 tJ ~~lJ
3.3 ?i1m1t:l ~m 'IJ~ tJ'U"ll'U1\11 b"1~fl11lJ m1 mlJm1lJ~ei-:i m11.ff-:i1tJ"IJB-!!V1'1.i1tJ-:i1tJ ~
3.4 ei'IJmru~~~1tJm11''U1ei-:i ~tJ~1\11n~1i!m1tJflru~m1lJm1mV111bb"1~tJ1 '
~
('U1tJD~'U1'Vl Pi11'19ltJ) ('U1tJ Plfl1~ oLJ'U\9ltJ1'U1-!!?l)
((}tv
(tJ1-:i?i11-5i;:i\ltJ1 b ~tJ1f\'1) ' ' '
' 0 ., 'U1 tJ bb'\Al'VltJ'IJ1'U1fY f111'\Al bPl't'f ' 0 'U1 tJbb '\Al'VltJ'IJ1'U1tyf111