TiBase Smart Denture Awọn iyipada Eto Ilana Itọsọna

Awọn akoonu tọju
1 Awọn ilana fun Lilo (IFU)
2 Awọn iwe aṣẹ / Awọn orisun
2.1 Awọn itọkasi
3 jẹmọ Posts

Awọn ilana fun Lilo (IFU)

Aami olupese Olupese:
Smart Denture Awọn iyipada, LLC
1800 N. Salem St.
Suite 104
Apex NC, ọdun 27523
855-550-0707
www.SmartDentureConversions.com

Ikẹkọ:
Awọn apejuwe wọnyi ko to lati gba lilo lẹsẹkẹsẹ ti Smart Denture Awọn iyipada' eto.
Imọ ti itọju prosthetic ti a fi sii ati itọnisọna ni mimu ti eto Awọn Iyipada Smart Denture ti a pese nipasẹ oniṣẹ pẹlu iriri ti o yẹ jẹ pataki. O ti wa ni strongly niyanju wipe titun
ati awọn olumulo ti o ni iriri ti Awọn Iyipada Iyipada Smart Denture pari ikẹkọ pataki ṣaaju lilo ọja tuntun fun igba akọkọ. Smart Denture Awọn iyipada nfunni ni ọpọlọpọ awọn aṣayan ikẹkọ. Jọwọ lọ si www.SmartDentureConversions.com fun alaye siwaju sii.

Apejuwe ọja:
Smart Denture Awọn iyipada 'TiBases ni a mu ninu ehin tabi prosthesis bi wiwo pẹlu ẹyọ-ọpọlọpọ
abutment. Nwọn pese awọn dabaru ijoko fun Prosthetic dabaru. Smart Denture Awọn iyipada 'TiBases Igba diẹ ni a funni ni ọna kika mẹrin ati awọn giga meji, fun apapọ 8 TiBases. Awọn TiBases Cementable ni a funni ni awọn ọna kika meji.
Tabili ti o wa ni isalẹ ṣe akopọ awọn oriṣi oriṣiriṣi:

Oruko Nọmba apakan Isunmọ Giga Ohun elo # ti Awọn lilo
Standard Ti Mimọ, SDC SF-003 4.6mm Titanium alloy –Ti-6AI-4V ELI(90% Ti, 6% Al, 4% V ELI) Nikan
Ga Ti Base, SDC SF-004 6.1mm
Cementable Ti Base, SDC SF-006 5.3mm
Standard Ti Base, Paltop PT-003 4.6mm
Ga Ti Base, Pal oke PT-004 6.1mm
Standard TiBase, TSV SF-012 4.6mm
TiBase ti o ga, TSV SF-012L 6.1mm
Standard TiBase, Omnibut OA-003 4.6mm
TiBase ti o ga, Omnibut OA-003L 6.1mm
Cementable Ti Base, Omni sugbon OA-006 5.3mm

Awọn itọkasi fun Lilo:
Ti Awọn ipilẹ ti wa ni itọkasi fun lilo pẹlu dabaru-idaduro ọpọ-kuro abutments ni maxilla ati mandible. Standard TiBases yẹ ki o ṣee lo nigbati o kere ju 75% ti TiBase le wa ni ifibọ sinu akiriliki lakoko gbigbe. Nigbati àsopọ naa ko ba gba laaye fun Awọn TiBases Standard, Awọn TiBases Ga le ṣee lo fun gbigbe to dara. Awọn TiBases Cementable jẹ ayanfẹ nigbati a ṣe iṣelọpọ prosthesis pẹlu awọn apo kongẹ fun simenti ti TiBase kan. Smart Denture Awọn iyipada 'TiBases jẹ ipinnu fun lilo ẹyọkan. Tun-lilo awọn ẹrọ lilo ẹyọkan ṣẹda eewu ti o pọju ti alaisan tabi ikolu olumulo ati aṣiṣe awọn paati ibamu. Fun alaye diẹ sii kan pato lori awọn igbesẹ ilana, jọwọ tọka si
Ilana Afowoyi be lori awọn webojula www.SmartDentureConversions.com.

Awọn itọkasi:
O jẹ ilodi si lilo Smart Denture Awọn iyipada 'TiBases ni:

  • Awọn alaisan ti ko yẹ ni ilera fun ilana iṣẹ abẹ ẹnu.
  • Awọn alaisan ninu eyiti awọn iwọn to peye, awọn nọmba tabi awọn ipo iwunilori ti awọn aranmo ko le de ọdọ lati ṣaṣeyọri
    atilẹyin ailewu ti iṣẹ-ṣiṣe tabi awọn ẹru parafunctional bajẹ.
  • Awọn alaisan ti o ṣe afihan awọn ami ti aleji tabi aibalẹ si awọn paati kemikali ti awọn ohun elo ti a ṣe akojọ si ni chart loke.

Ikilọ:

  • Awọn paati ni lati lo nipasẹ awọn alamọdaju itọju ilera ehín ati pe o yẹ ki o lo ni awọn alaisan ti o wa labẹ itọju gbin ehin.
  • Ti itọkasi tabi iru lilo ko ba han, ma ṣe lo titi gbogbo awọn aaye yoo fi ṣe alaye.
  • Ma ṣe lo ti package ba ti bajẹ.
  • Ṣayẹwo awọn paati nigbagbogbo ṣaaju lilo. Ma ṣe lo ti bajẹ, dibajẹ, ibajẹ, tabi awọn paati awọ.
  • Imujuju le fa TiBase tabi awọn paati miiran lati di dibajẹ, fifọ tabi di lori afọwọṣe ifibọ tabi abutment, ti o fa ibajẹ si awọn paati.
  • Rii daju pe awọn ọja wa ni ifipamo lodi si ifojusọna nigbati a ba mu ni inu inu. Ifojusi awọn ọja le ja si ikolu tabi ipalara ti ara ti a ko gbero.
  • Ikuna lati tẹle awọn ilana ti a ṣe ilana ni awọn ilana wọnyi le ja si eyikeyi tabi gbogbo awọn ilolu wọnyi: Ifẹ tabi gbigbe awọn paati, itọju atẹle, ifihan ti ko tọ ti o yorisi awọn imupadabọ ibaramu.
  • Paapaa ti o ba jẹ pe a lo ọja naa ni ibamu si awọn ilana fun lilo, abajade ile-iwosan ti itọju ehín ni ipa nipasẹ awọn oniyipada pupọ ati pe o le ja si eyikeyi tabi gbogbo awọn ilolu wọnyi: anafilasisi (idahun inira to lagbara); aspiration tabi gbigbe awọn paati; irora; ikolu agbegbe; igbona; ibinu agbegbe; isonu ti iṣẹ ọja; itọju atẹle.
  • Smart Denture Awọn iyipada ko ṣe oniduro fun ibajẹ ti o waye lati lilo ita lilo ọja ti a pinnu.

Awọn iṣọra/Iṣọra:
Awọn iṣọra atẹle ni a nilo ṣaaju tabi lakoko itọju:

  • Maṣe lo awọn ohun elo Iyipada Iyipada ehin Smart lẹhin ọjọ ipari lori apoti (ti o ba wulo).
  • Gbogbo awọn ọja ti a pinnu fun lilo ẹyọkan ko gbọdọ tun lo. Tun-lilo awọn ẹrọ lilo ẹyọkan ṣẹda eewu ti o pọju ti alaisan tabi ikolu olumulo ati awọn paati aiṣedeede.
  • Ṣaaju ilana gbogbo rii daju pe gbogbo awọn paati ti a beere, awọn ohun elo, ati ohun elo iranlọwọ ti pari, ni ilana ṣiṣe ati pe o wa ni iwọn ti o nilo.
  • Rii daju pe oju abutment jẹ mimọ ṣaaju gbigbe TiBases.
  • Ti, nitori awọn ipo anatomical ti ko dara, awọn ohun elo ko baamu tabi ko le ṣee lo fun awọn idi miiran, ilana itọju ti a gbero pẹlu wọn ko gbọdọ tẹsiwaju ati awọn omiiran gbọdọ wa.
  • Nigbagbogbo wọ ohun elo aabo ti ara ẹni fun aabo tirẹ.
  • Gbe alaisan si iru eyi ti ewu ifọkansi ti awọn paati ti dinku.
  • Gbogbo awọn paati ti a lo ni ẹnu alaisan gbọdọ wa ni ifipamo lati ṣe idiwọ ifẹnukonu ati gbigbe.
  • Ṣe akiyesi awọn iyipo pàtó kan.

Alaye Aabo Aworan Aworan Resonance (MRI):
Gbogbo awọn ọja Iyipada Smart Denture eyiti o wa ninu ara alaisan ko ti ni iṣiro fun ailewu ati ibaramu ni agbegbe MR. Wọn ko ti ni idanwo fun alapapo, ijira, tabi aworan aworan ni agbegbe MR. Aabo ti Smart Denture Awọn ọja Iyipada ni agbegbe MR jẹ aimọ. Ṣiṣayẹwo alaisan ti o ni iru ọja le ja si ipalara alaisan.

Awọn ilana isọdi-ara:
Awọn ẹya ara ẹrọ ti wa ni jiṣẹ ti kii ṣe ni ifo nipasẹ Awọn iyipada Smart Denture ati pe a pinnu fun lilo ẹyọkan. Ṣaaju lilo, awọn ẹrọ gbọdọ jẹ sterilized nipasẹ olumulo.
Smart Denture Awọn iyipada ṣeduro ilana atẹle fun sterilization ṣaaju lilo. A ṣe iṣeduro sterilization lati ṣe ni ibamu si ero atẹle:

  1. Igbaradi fun sterilization: Gbe awọn paati (to awọn ẹrọ 6) sinu apo sterilization eyiti o jẹ mimọ-FDA fun ọmọ ti a pinnu.
  2. Isọdọmọ:
Ọna Yiyipo   Iwọn otutu Àkókò ìsírasílẹ̀* Akoko gbigbẹ
Nya si Yiyọ Afẹfẹ Yiyọ kuro (Iṣaju) 132°C (270°F) 4 iṣẹju 20 iṣẹju
Nya si Walẹ nipo 121°C (250°F) 30 iṣẹju 30 iṣẹju

Ibi ipamọ, Mimu ati Gbigbe:
Awọn ẹrọ gbọdọ wa ni ipamọ ni aaye gbigbẹ ninu apoti atilẹba wọn ni iwọn otutu yara ati aabo lati orun taara. Ibi ipamọ aibojumu le ba ohun elo pataki ati awọn abuda apẹrẹ jẹ, ti o yori si ikuna ẹrọ.

Idasonu:
Lailewu sọ aibikita ti o ti doti tabi awọn ẹrọ iṣoogun ti ko ṣee lo mọ bi egbin ilera (ile-iwosan) ni ibamu pẹlu awọn itọnisọna ilera agbegbe, orilẹ-ede ati ofin ijọba tabi eto imulo. Iyapa, atunlo tabi
sisọnu ohun elo iṣakojọpọ yoo tẹle orilẹ-ede agbegbe ati ofin ijọba lori apoti ati egbin apoti, nibiti o ba wulo. Ti ko ba si ofin lọwọlọwọ, gbe wọn sinu apo idalẹnu apanirun / apo idalẹnu didasilẹ ki o sọ wọn sinu egbin ile-iwosan.

Apejọ ati Alaye UD: 

Tabili ti o tẹle ṣe atokọ alaye UDI-DI Ipilẹ fun awọn ẹrọ ti a ṣalaye ninu IFU yii.

Ọja Nọmba katalogi To wa Awọn ẹya Nọmba UDI-DI ipilẹ
Standard TiBase 10-Pack STB10PK SF-003 + D990STB10PK0
Ga TiBase 10-Pack TTB10PK SF-004 + D990TTB10PK0
Ere Starter Apo, SDC PSK SF-003 / SF-004 +D990PSK0
Ibẹrẹ Apo, SDC SK SF-003 / SF-004 +D990SK0
Apo gbigba agbara w / Awọn ẹya apoju giga, SDC RK SF-003 / SF-004 +D990RK0
Apo gbigba agbara w/ POC, SDC RKPOC SF-003 + D990RKPOC0
Iyapa Fastener Apejọ 10-pack pẹlu Drill kit SFA10PKDK SF-003 + D990SFA10PKDK0
Ga apoju Apo, SDC TSP SF-004 +D990TSP0
Ere Starter Apo, Straumann PSK-ST SF-003 / SF-004 + D990PSK-ST0
Starter Apo, Straumann SK-ST SF-003 / SF-004 + D990SK-ST0
Apo gbigba agbara w / Awọn apakan apoju giga, Straumann RK-ST SF-003 / SF-004 + D990RK-ST0
Apo gbigba agbara w / POC, Stroman RKPOC-ST SF-003 + D990RKPOC-ST0
Ga apoju Apo, Straumann TSP-ST SF-004 + D990TSP-ST0
Iyapa Fastener Apejọ 10-pack pẹlu Drill kit, Stroman SFA10PKDK-ST SF-003 + D990SFA10PKDK-ST0
Ere Starter Apo, TiLobe KDTL-PSK SF-003 / SF-004 + D990KDTL-PSK0
Starter Apo, TiLobe KDTL-SK SF-003 / SF-004 + D990KDTL-SK0
Apo gbigba agbara w / Awọn apakan apoju giga, TiLobe KDTL-RK SF-003 / SF-004 + D990KDTL-RK0
Apo gbigba agbara w / POC, TiLobe KDTL-RKPOC SF-003 + D990KDTL-RKPOC0
Iyapa Fastener Apejọ 10-pack with Drill Kit, TiLobe KDTL-SFA10PKDK SF-003 + D990KDTL-SFA10PKDK0
Ga apoju Apo Kit, Ti Lo be KDTL-TSP SF-004 + D990KDTL-TSP0
Ere Starter Apo, Pal oke KDIH-PSK PT-003 / PT-004 + D990KDIH-PSK0
Starter Kit, Pal oke KDIH-SK PT-003 / PT-004 + D990KDIH-SK0
Apo gbigba agbara w / Awọn apakan apoju giga, Pal oke KDIH-RK PT-003 / PT-004 + D990KDIH-RK0
Apo gbigba agbara w/ POC, Pal oke KDIH-RKPOC PT-003 + D990KDIH-RKPOC0
Iyapa Fastener Apejọ 10-pack pẹlu Drill kit, Pal oke KDIH-SFA10PKDK PT-003 + D990KDIH-SFA10PKDK0
Ga apoju Apo, Pal oke KDIH-TSP PT-004 + D990KDIH-TSP0
Standard TiBase 10-Pack, Pal oke (I-Hex) KDIH-STB10PK PT-003 + D990KDIH-STB10PK0
TiBase Giga 10-Pack, Paltop (I-Hex) KDIH-TTB10PK PT-004 + D990KDIH-TTB10PK0
Ere Starter Apo, Bio Horizons BHHD-PSK PT-003 / PT-004 + D990BHHD-PSK0
Starter Kit, Bio Horizons BHHD-SK PT-003 / PT-004 + D990BHHD-SK0
Apo gbigba agbara w / Awọn apakan apoju giga, Awọn Horizons Bio BHHD-RK PT-003 / PT-004 + D990BHHD-RK0
Apo gbigba agbara w / POC, BioHorizons BHHD-RKPOC PT-003 + D990BHHD-RKPOC0
Iyapa Fastener Apejọ 10-pack pẹlu Drill kit, BioHorizons BHHD-SFA10PKDK PT-003 + D990BHHD-SFA10PKDK0
Ga apoju Apo, 0.05 "Hex FZMF-TSP SF-004 + D990FZMF-TSP0
Ere Starter Apo, TSV ZVTS-PSK SF-003 / SF-004 + D990ZVTS-PSK0
Ere Starter Apo, Low Profile ZVLP-PSK SF-012/SF-012L + D990ZVLP-PSK0
Apo gbigba agbara w / Awọn apakan apoju giga, TSV ZVTS-RK SF-003 / SF-004 + D990ZVTS-RK0
Apo gbigba agbara w / Awọn apakan apoju giga, Pro Lowfile ZVLP-RK SF-012/SF-012L + D990ZVLP-RK0
Ohun elo gbigba agbara w / POC, TSV ZVTS-RKPOC SF-003 + D990ZVTS-RKPOC0
Apo gbigba agbara w / POC, Low Profile ZVLP-RKPOC SF-012 + D990ZVLP-RKPOC0
Iyapa Fastener Apejọ 10PK - Drill KitIncluded, TSV ZVTS-SFA10PKDK SF-003 + D990ZVTS-SFA10PKDK0
Iyapa Fastener Apejọ 10PK - Liluho KitIncluded, Low Profile ZVLP-SFA10PKDK SF-012 + D990ZVLP-SFA10PKDK0
Standard TiBase 10PK, TSV ZVTS-STB10PK SF-003 + D990ZVTS-STB10PK0
Standard TiBase 10PK, Low Profile ZVLP-STB10PK SF-012 + D990ZVLP-STB10PK0
Ga TiBase 10PK, TSV ZVTS-TTB10PK SF-004 + D990ZVTS-TTB10PK0
TiBase Ga 10PK, Low Profile ZVLP-TTB10PK SF-012L + D990ZVLP-TTB10PK0
Standard Omni ṣugbọn TiBase, 10 PK STB10PK-OA OA-003 + D990STB10PK-OA0
Omni ti o ga ṣugbọn TiBase, 10 PK TTB10PK-OA OA-003L + D990TTB10PK-OA0
Ere Starter Apo, Omni ṣugbọn PSK-OA OA-003 / OA-003L + D990PSK-OA0
Apo gbigba agbara w / Awọn apakan apoju giga, Omni ṣugbọn RK-OA OA-003 / OA-003L + D990RK-OA0
Apo gbigba agbara w/ POC, Omni ṣugbọn RKPOC-OA OA-003 + D990RKPOC-OA0
Iyapa Fastener Apejọ 10-pack pẹlu Drill kit, Omni ṣugbọn SFA10PKDK-OA OA-003 + D990SFA10PKDK-OA0
Cementable TiBase 10PK, SDC CTB10PK SF-006 + D990CTB10PK0
Cementable TiBase 10PK, Omni ṣugbọn CTB10PK-OA OA-006 + D990CTB10PK-OA0

Wiwulo:
Lẹhin titẹjade awọn ilana wọnyi fun lilo, gbogbo awọn ẹya ti tẹlẹ ti wa ni rọpo.

Wíwà:
Diẹ ninu awọn ohun kan ti Smart Denture Awọn iyipada ko si ni gbogbo awọn orilẹ-ede.

Atilẹyin ọja:
Jọwọ ṣabẹwo www.SmartDentureConversions.com fun alaye atilẹyin ọja ti o ga julọ julọ.

Awọn aami Gilosari:
Awọn aami atẹle le wa lori isamisi ẹrọ tabi ni alaye ti o tẹle ẹrọ naa. Tọkasi aami ẹrọ tabi alaye to tẹle fun awọn aami to wulo.

Aami olupese Olupese Ọjọ ti iṣelọpọ
Lo Nipa Ọjọ Nomba siriali
Ipele Code Nọmba katalogi
Oto Device idamo Ẹrọ Iṣoogun
CE Samisi Aṣoju UK
United Kingdom Ibamu Igbelewọn Mark Samisi Igbelewọn Ibamubamu United Kingdom pẹlu Nọmba Ara Ifọwọsi
European Asoju Ti kii-Sterile
Wa sterilized Wa sterilized nipa lilo Sisẹ Aseptic
Wa Sterilized nipa lilo Ethylene Oxide Processing Wa sterilized nipa lilo ilana Iradiation
Wa sterilized lilo Gbẹ Heat Processing Maṣe ṣe atunto
Maṣe tun lo Kan si Awọn ilana fun Lilo
Jeki Gbẹgbẹ Jeki kuro lati orun
RX Nikan Fun Lilo Oogun Nikan Išọra, Kan si Awọn iwe aṣẹ ti o tẹle
Maṣe Lo Ti Iṣakojọpọ ba bajẹ

Awọn iwe aṣẹ / Awọn orisun

Iyipada ehin SMART TiBase Smart Denture Awọn iyipada Eto [pdf] Ilana itọnisọna
SF-003, SF-004, SF-006, PT-003, PT-004, SF-012, SF-012L, OA-003, OA-003L, OA-006, TiBase Smart Denture Awọn iyipada System, TiBase, Smart Denture Awọn iyipada System, Denture System, Denture System.

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