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Orthofix SambaScrew SI Fixation System, Инструкция по эксплуатации

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INSTRUCTIONS FOR USE

Important Information – Please Read Prior to Use

Orthofix Inc.

3451 Plano Parkway

Lewisville, Texas 75056-9453 U.S.A.

1-214-937-3199

1-888-298-5700

www.orthofix.com

Medical Device Safety Service 

(MDSS)

Schiffgraben 41  

30175 Hannover

Germany

+49 511 6262 8630

www.mdss.com

Device System Name:

SambaScrew

®

 SI Fixation System

Description:

The SambaScrew SI Fixation System is a temporary, multiple component system consisting of 

non-sterile instruments and non-sterile, medical-grade titanium (Ti-6Al-4V ELI) implants. The 

system consists of a 9mm diameter, cannulated screw with multiple orifices on its shaft.  The 

Steinmann Pins, Variable Drill Bit, and Packing Tube are single use devices and should be 

discarded after use. 

Indications for Use:

The SambaScrew SI Fixation System is intended for fixation of sacroiliac joint disruptions. This 

fixation device is to only be used in skeletally mature patients.

Contraindications:

The SambaScrew SI Fixation System is contraindicated for use in patients with:

1.  Open wounds, infection, presence of tumor, pregnancy, osteoporosis, certain metabolic 

disorders affecting osteogenesis, certain inflammatory/neuromuscular conditions, and 

certain neuromuscular deficits which would place an unusually heavy load on the device 

during the healing period.

2.  The implant is made from Ti-6Al-4V ELI (medical-grade titanium alloy).  The fixation 

implant is contraindicated in any individual with a known or suspected allergy, sensitivity 

or intolerance to metal.

Potential Adverse Events:

Potential adverse events include, but are not limited to:

1.  Allergic reaction or metal sensitivity to foreign body.

2.  Cardiovascular system compromise.

3. Death.

4.  Decrease in bone density due to stress shielding.

5.  Device bending, disassembly, fracture, loosening, migration and/or retropulsion, or subsid-

ence.

6.  Dural tears, neural structure injury.

7.  Fixation implant migration with or without bone fracture.

8.  Fracture of pelvis or sacrum.

9.  Gastrointestinal complications (i.e., ileus or bowel perforation).

10. Hemorrhage.

11.  Incisional complications (i.e., dehiscence, hematoma).

12.  Infection (Incisional or implant site).

13.  Loss of spinal mobility or function.

14.  Loosening or fracture of fixation implant.

15.  Malfunction of fixation device and/or instruments.

16.  Malposition of the fixation device.

17.  Migration of fixation implant.

18.  Neurological injury/deficit which may range from paresthesias to muscle paralysis, loss of 

rectal or bladder sphincter control, radiculopathies.

19.  Organ, connective tissue or nerve damage.

20. Osteoarthritis.

21.  Pain, discomfort or abnormal sensation due to device presence.

22.  Persistent low back pain.

23.  Reproductive system compromise.

24.  Screw back-out or breakage possibly leading to local pain, perforation or irritation of 

adjacent structures.

25. Sepsis.

26.  Urological compromise (i.e., infection/retention).

27.  Vascular injury.

28.  Wound hematoma.

Note:

 Additional surgery may be necessary to correct some of these anticipated adverse events.

Warnings and Precautions:

1.  The SambaScrew device should only be used by surgeons who have been trained in the 

use of this device. Information on laboratory and clinical training, as well as additional 

brochures with a detailed description of proper surgical technique, may be obtained from 

Orthofix. See the SambaScrew SI Fixation System Surgical Manual for instructions on the 

implant procedure.

2.  Infection may occur immediately following implant fixation or a long time afterwards due 

to transient bacteremia such as caused by dental treatment(s), endoscopic examination or 

any other minor surgical procedure. To avoid infection at the implant fixation site, it may 

be advisable to use antibiotic prophylaxis before and/or after such procedures.

MRI Compatibility Information:

  

The SambaScrew SI Fixation System has not been evaluated for safety and compatibility in the 

Magnetic Resonance (MR) environment. This system has not been tested for heating or migration 

in the MR environment.

Cleaning:

Implants are provided clean but not sterile. Once an implant comes in contact with any human 

tissue or bodily fluid, it should not be re-sterilized or used. Please discard all contaminated 

implants.

All instruments must be thoroughly cleaned after each use using the manual or automated 

cleaning procedure listed below.

From Point of Use:

Whenever possible, do not allow the blood, debris or body fluids to dry on instruments. For best 

results and to prolong the life of the surgical instrument, reprocess immediately after use.

Cleaning may be done using validated hospital methods or following the validated cleaning 

process described below.

Preparation for Cleaning:

 

1.  Keep used instruments moist and do not allow blood and/or bodily fluids to dry on the 

instruments. 

2.  Remove gross contaminants with a steady stream of lukewarm/cool water (below 

110°F/43°C). Rinse each instrument thoroughly. Do not use saline or chlorinated solutions.  

3.  Disassemble components to expose all surfaces and clean separately. See following sec-

tions for assembly and disassembly instructions.

Instructions for Disassembly: 

1.  Parallel Guide Set (PN 11-1109-FD7):

 

There are three parts to the Parallel Guide Set: 1. Locking Nut, 2. Sliding Block, and 3. 

Parallel Guide Frame. The Parallel Guide Set requires disassembly prior to cleaning using the 

followin steps:

 

a.  Unthread the Nut from the Sliding Block.

 

b.  Remove the Sliding Block from the Parallel Guide Frame.

2.  Packing Plunger (11-1109-FD8-1) and Packing Tube (11-1109-FD8-2):

 

There are two parts: 1. Packing Plunger and 2. Packing Tube (single use only). The Packing 

Plunger and Packing Tube require disassembly prior to cleaning using the following steps:

 

a.  Remove the Plunger from the Tube.

 

b.  Discard the Tube, which is single use only. Do not discard the Plunger.

3.  Variable Drill Bit (PN 11-1109-FD9-1) and Adjustable Drill Collar (PN 11-1109-FD9-2):

 

There are two parts: 1. Variable Drill Bit (single use only) and 2. Drill Collar. The Variable 

Drill Bit and Adjustable Drill Collar require disassembly prior to cleaning using the follow-

ing steps:

 

a.  Disengage the Drill Collar from the Variable Drill Bit’s shaft.

 

b.  Slide the Drill Collar over the Drill Bit Shank to take it off.

c.  Discard the Variable Drill Bit, which is single use only. Do not discard the Adjustable 

Drill Collar.

Automated Cleaning:

Instruments should be cleaned using the following automated cleaning process steps:

Note: 

Do not use cleaning solutions containing bleach or formalin since they may damage the 

instrument.

For ultrasonic cleaning, follow manufacturer’s specification for water level, concentration levels 

of cleaning agent and temperature.

0086

TREATMENT

TIME 

(MM:SS)

TEMPERATURE

CLEANING SOLUTION

Enzymatic 

Wash

04:00

60°C

Steris

®

 Prolystica

®

 2X Concentrate Enzyme 

Presoak (1/4 oz. per fluid gallon)

Wash

02:00

Warm Tap Water

Steris

®

 Prolystica

®

 2X Concentrate Neutral 

Detergent (1/4 oz. per fluid gallon)

Rinse

02:00

70°C

N/A

Dry

As Needed

20°C – 80°C

N/A

Содержание SambaScrew SI Fixation System

Страница 1: ...Name SambaScrew SI Fixation System Click directory below for desired language INSTRUCTIONS FOR USE Important Information Please Read Prior to Use Orthofix Inc 3451 Plano Parkway Lewisville Texas 75056 9453 U S A 1 214 937 3199 1 888 298 5700 www orthofix com Medical Device Safety Service MDSS Schiffgraben 41 30175 Hannover Germany 49 511 6262 8630 www mdss com AW 11 9901 Rev AA PK 1602 PL US Ortho...

Страница 2: ...s on the implant procedure 2 Infection may occur immediately following implant fixation or a long time afterwards due to transient bacteremia such as caused by dental treatment s endoscopic examination or any other minor surgical procedure To avoid infection at the implant fixation site it may be advisable to use antibiotic prophylaxis before and or after such procedures MRI Compatibility Informat...

Страница 3: ... standard sterilization cycles Users should only use sterilizers and accessories such as sterilization wraps sterilization pouches chemical indicators biological indicators and sterilization containers that have been cleared by the US FDA for the following selected gravity sterilization cycle specification Method Steam or Method Steam Cycle Gravity Cycle Gravity Temperature 273 F 134 C Temperature...

Страница 4: ...ación SI SambaScrew SambaScrew SI Fixation System Surgical Manual para obtener instrucciones sobre el procedimiento de implante 2 Pueden producirse infecciones inmediatamente después de la fijación del implante o mucho tiempo después debido a bacteriemia transitoria tal como la causada por tratamientos dentales exámenes endoscópicos o cualquier otro procedimiento quirúrgico menor Para evitar infec...

Страница 5: ...rilización que han de utilizarse en Estados Unidos con los estuches de instrumental Método Vapor Ciclo Prevacío Temperatura 132 C Tiempo de exposición 4 minutos Tiempo de secado No procede ciclo de uso inmediato La United States Food and Drug Administration US FDA no considera ciclos de esterilización estándar a los siguientes ciclos de esterilización por gravedad Los usuarios solamente deberán ut...

Страница 6: ...m Surgical Manual pour obtenir les directives relatives à la procédure d implantation 2 Une infection peut se produire immédiatement après la fixation de l implant ou très longtemps après en raison d une bactériémie transitoire similaire à celles provoquées par les traitements dentaires les examens par voie endoscopique ou toute autre intervention chirurgicale mineure Pour éviter une infection au ...

Страница 7: ...s boîtiers à instruments aux États Unis Méthode Vapeur Cycle Pré vide Température 132 C Durée d exposition 4 minutes Temps de séchage S O Cycle pour utilisation immédiate Les cycles de stérilisation à déplacement par gravité suivants ne sont pas considérés comme des cycles de stérilisation standard par la Food and Drug Administration FDA américaine Les utilisateurs doivent uniquement employer des ...

Страница 8: ...sulla procedura dell impianto consultare il Manuale chirurgico del sistema di stabilizzazione SambaScrew SI SambaScrew SI Fixation System Surgical Manual 2 È possibile l insorgenza di infezioni immediatamente dopo la stabilizzazione dell impianto o dopo molto tempo a causa di batteriemia transitoria causata ad esempio da trattamenti dentali esame endoscopico o altre procedure chirurgiche minori Pe...

Страница 9: ...ametri procedurali indicati di seguito Parametri di sterilizzazione per l utilizzo negli Stati Uniti delle cassette per gli strumenti Metodo a vapore Ciclo prevuoto Temperatura 132 C Tempo di esposizione 4 minuti Tempo di asciugatura ND Ciclo di utilizzo immediato I seguenti cicli di sterilizzazione a gravità non sono ritenuti cicli di sterilizzazione standard dall ente FDA degli Stati Uniti Gli u...

Страница 10: ...uch für das SambaScrew SI Fixationssystem SambaScrew SI Fixation System Surgical Manual zu entnehmen 2 Aufgrund von transienter Bakteriämie die von Zahnbehandlungen endoskopischen Untersuchungen oder anderen kleinen chirurgischen Eingriffen verursacht wird kann unmittelbar nach der Implantat Fixation oder eine lange Zeit danach eintreten Um eine Infektion an der Implantat Fixationsstelle zu vermei...

Страница 11: ...n den Vereinigten Staaten für Instrumentenkasten Methode Dampf Zyklus Vorvakuum Temperatur 132 C Expositionszeit 4 Minuten Trocknungsdauer Nicht zutreffend Soforteinsatz Zyklus Die folgenden Schwerkraftsterilisationszyklen werden von der United States Food and Drug Administration US FDA US amerikanischen Lebensmittel und Arzneimittelbehörde nicht als standardmäßige Sterilisationszyklen erachtet Di...

Страница 12: ...bakteriyemi nedeniyle uzun bir süre sonra oluşabilir İmplant fiksasyonu bölgesinde enfeksiyondan kaçınmak için bu tür işlemlerden önce ve veya sonra antibiyotik profilaksisi kullanmak uygun olabilir MRG Uyumluluk Bilgileri SambaScrew SI Fiksasyon Sistemi Manyetik Rezonans MR ortamında güvenlik ve uyumluluk açısından değerlendirilmemiştir Bu sistem MR ortamında ısınma veya yer değiştirme için test ...

Страница 13: ...döngüleri kabul edilmez Kullanıcılar aşağıdaki seçilmiş yerçekimi sterilizasyon döngüsü spesifikasyonu için sadece A B D FDA tarafından izin verilmiş sterilizatörler ve aksesuarlar sterilizasyon sargıları sterilizasyon poşetleri kimyasal göstergeler biyolojik göstergeler ve sterilizasyon kapları gibi kullanmalıdır Yöntem Buhar veya Yöntem Buhar Döngü Yerçekimi Döngü Yerçekimi Sıcaklık 134 C Sıcakl...

Страница 14: ...eriemia transitória como a causada por tratamento s dentário s exame endoscópico ou qualquer outra pequena intervenção cirúrgica Para evitar infeção no local de fixação do implante pode ser aconselhável fazer profilaxia com antibiótico antes e ou depois de tais procedimentos Informação sobre compatibilidade com ressonância magnética O sistema de fixação SambaScrew SI não foi avaliado relativamente...

Страница 15: ...ão por gravidade seguintes não são considerados pela United States Food and Drug Administration Agência de Alimentos e Medicamentos dos EUA US FDA como sendo ciclos de esterilização padrão Os utilizadores só devem utilizar esterilizadores e acessórios como invólucros de esterilização bolsas de esterilização indicadores químicos indicadores biológicos e recipientes de esterilização aprovados pela U...

Страница 16: ...dure 2 Infectie kan optreden onmiddellijk na de fixatie van het implantaat of een lange tijd daarna als gevolg van voorbijgaande bacteriëmie zoals bijvoorbeeld veroorzaakt door tandheelkundige behandeling en endoscopisch onderzoek of een andere kleine chirurgische ingreep Om infectie te voorkomen op de plaats waar het implantaat is gefixeerd kan het wenselijk zijn antibiotische profylaxe te gebrui...

Страница 17: ...e zwaartekrachtsterilisatiecycli worden door de United States Food and Drug Administration US FDA niet beschouwd als standaardsterilisatiecycli Gebruikers mogen uitsluitend sterilisators en accessoires zoals sterilisatiepapier sterilisatiezakken chemische indicatoren biologische indicatoren en sterilisatiehouders gebruiken die door de US FDA zijn toegestaan voor de geselecteerde zwaartekrachtsteri...

Страница 18: ...οσκοπική εξέταση ή οποιαδήποτε άλλη ελάσσονα χειρουργική επέμβαση Για να αποτραπεί τυχόν λοίμωξη στη θέση καθήλωσης του εμφυτεύματος μπορεί να συνιστάται η χρήση προφυλακτικής αντιβιοτικής αγωγής πριν ή και μετά από τέτοιες επεμβάσεις Πληροφορίες συμβατότητας με μαγνητική τομογραφία Το σύστημα καθήλωσης SI SambaScrew δεν έχει αξιολογηθεί ως προς την ασφάλεια και τη συμβατότητα σε περιβάλλον μαγνητ...

Страница 19: ...ία 132 C Χρόνος έκθεσης 4 λεπτά Χρόνος στεγνώματος Δ Ε Κύκλος για άμεση χρήση Οι παρακάτω κύκλοι αποστείρωσης με βαρύτητα δεν θεωρούνται από τον United States Food and Drug Administration ΟργανισμόςΤροφίμων και Φαρμάκων των Η Π Α US FDA ως τυπικοί κύκλοι αποστείρωσης Οι χρήστες θα πρέπει να χρησιμοποιούν μόνο αποστειρωτές και παρελκόμενα όπως περιτυλίγματα αποστείρωσης θήκες αποστείρωσης χημικούς ...

Страница 20: ...物質の感染予防薬を手技の前後に使用すること が推奨されます MR適合性についての情報 SambaScrew SI固定システムは MR環境における安全性および適合性について検査 されていません 本システムは MR環境における加熱および移動について検査されて いません 洗浄 インプラントは洗浄済み 未滅菌で提供されます インプラントが一度ヒトの組織また は体液に触れた場合 再滅菌または使用してはなりません 汚染されたインプラントは すべて廃棄してください すべての器具は 使用後毎回 下記の用手または自動洗浄手順で完全に洗浄してくだ さい 使用時点から 可能な限り 血液 残屑または体液が器具上で乾燥しないようにします 最良の結果お よび手術器具の寿命を長く維持するために 使用後はすぐに再処理を行います 有効な院内手順を用いて または下記の有効な洗浄手順に従って 洗浄を行えます 洗浄の準備 1 使...

Страница 21: ...間 該当なし 即時使用サイクル 以下の重力置換滅菌サイクルは FDAにより標準的滅菌サイクルと認められています 使用者は 以下の所定の重力置換滅菌サイクル仕様に対して 米国FDAが認めた滅菌 器および付属品 滅菌ラップ 滅菌パウチ 化学的インジケータ 生物学的インジケー タ 滅菌コンテナなど のみを使用する必要があります 方法 蒸気 または 方法 蒸気 サイクル 重力置換 サイクル 重力置換 温度 134 C 温度 121 C 暴露時間 20分間 暴露時間 60分間 乾燥時間 15 30分間 乾燥時間 15 30分間 注 滅菌には多くの変数があるため それぞれの病院で機器に使用する滅菌プロセス 例 温度および時間 を較正および確認する必要があります 米国外の医療専門家の中には 特に中枢神経系と接触する可能性がある手術器具に ついて Creutzfeldt Jakob病感染の潜在的リスクを最...

Страница 22: ... 植入物提供時潔淨但並非無菌 植入物一旦與任何人類組織或體液接觸 即不應重複 滅菌或使用 請丟棄所有受到污染的植入物 每次使用後 必須遵循下列手動或自動清潔程序進行徹底清潔所有器械 在使用地點 儘量不要讓血液 碎屑或體液乾燥在器械上 為獲得最佳清潔效果和延長外科器械的 使用壽命 使用後要立即重新處理 可採用確證有效的醫院清潔方法或遵循下述確證有效的清潔流程進行清潔 清潔準備 1 用過的器械要保持濕潤 不要讓血液和 或體液乾燥在器械上 2 使用連續不斷的微溫 涼水清除顯而易見的污染 低於 43 C 徹底沖洗每個器 械 請勿使用鹽水或氯水溶液 3 拆解部件以露出所有表面並分別清潔 請參閱以下部分中的組裝和拆解說明 拆解說明 1 平行導件套組 PN 11 1109 FD7 平行導件套組分成三個部件 1 自鎖螺帽 2 滑塊 以及 3 平行導架 在清潔之 前 需要按照下列步驟對平行導件套組進行拆解 ...

Страница 23: ... 20 分钟 暴露時間 60 分鐘 乾燥時間 15 30 分鐘 乾燥時間 15 30 分鐘 注意 因為滅菌存在很多變數 所以每個醫療機構應校正並驗證為其設備使用的滅菌 流程 例如溫度和時間 某些非美國醫療保健管理機構建議按照這些參數進行滅菌 以儘量降低傳播 Creutzfeldt Jakob 病的風險 尤其是對於可能與中樞神經系統接觸的外科器械 此滅 菌週期並未經過普粒子蛋白去活性驗證 藍色滅菌包裝紙包裝螺釘盒滅菌 SambaScrew SI 固定系統植入物以非無菌方式提供 使用之前 醫院應將所有植入物 放在適當的 Orthofix 螺釘盒內 使用 FDA 許可的滅菌包裝紙包裝 放在高壓蒸汽鍋內 採用以下建議的週期之一進行滅菌 方法 蒸汽 或 方法 蒸汽 週期 重力 週期 預抽真空 至少 4 次脈衝 溫度 132 C 溫度 132 C 暴露時間 15 分钟 暴露時間 4 分鐘 乾燥時間 3...

Страница 24: ... có thể khuyến khích sử dụng kháng sinh dự phòng trước và hoặc sau khi thực hiện thủ tục Thông tin vềTương thích MRI Chụp cộng hưởng từ Hệ thống Cố định SI SambaScrew chưa được đánh giá về tính an toàn và tương thích trong môi trường Cộng hưởng từ Magnetic Resonance MR Hệ thống này chưa được thử nghiệm về nhiệt hoặc di dịch trong môi trường Cộng hưởng từ Làm sạch Mô cấy khi được cung cấp đều sạch ...

Страница 25: ...Người sử dụng chỉ nên sử dụng các thiết bị khử trùng và phụ tùng chẳng hạn giấy bọc khử trùng túi khử trùng các chỉ số hóa chỉ số sinh học và các thùng chứa khử trùng đã được FDA Hoa Kỳ phê duyệt về đặc điểm kỹ thuật của chu kỳ khử trùng trọng lực được lựa chọn sau đây Phương pháp Hơi hoặc Phương pháp Hơi Chu kỳ Trọng lực Chu kỳ Trọng lực Nhiệt độ 134 C Nhiệt độ 121 C Thời gian tiếp xúc 20 phút Th...

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