ulrich medical uCentrum User manual

WS 3895-eIFU
R8.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
1
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
Gebrauchsanweisung
Instructions for use
Instructions for use
Mode d’emploi
Istruzioni per l'uso
Instrucciones de uso
Instruções de utilização
Brugsanvisning
Bruksanvisning
Käyttöohje
Kullanım Kılavuzu
Οδηγίε χρήση
Gebruiksaanwijzing
Bruksanvisning
  
Instruciunile de utilizare
  
Návod k použití
Lietošanas instrukcija
Instrukcja obsługi
Návod na použitie
Navodila za uporabo
󻸛󼐘󾖴󻺓󻟴󻺋
使用说明
uCentum™ comprehensive posterior system
Deutsch 2
English 7
USA 12
Français 20
Italiano 25
Español 30
Português 35
Dansk 40
Svenska 45
Suomi 50
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Ελληνικά 60
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 75
Română 80
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Česky 90
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中文 120
2019-05-06

WS 3895-eIFU
R8.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
2
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
SYSTEM: uCentum™ comprehensive posterior system
SPRACHE: Deutsch
Für Benutzer in USA gilt ausschließlich die spezielle Version für das Land USA.
Alle Anweisungen aufmerksam lesen. Ein Missachten der Anweisungen, Warnhinweise und Vorsichts-
maßnahmen kann zu schweren Folgen oder Verletzungen beim Patienten führen.
Vor der klinischen Anwendung alle Produktmaterialien sorgfältig beachten.
Die als Gesamtdokumentation zum System bereitgestellten notwendigen Produktmaterialien sind:
Systembezogene Gebrauchsanweisung, OP-Technik und ggf. Supplements, Montage- und Demonta-
geanleitungen sowie das„Aufbereitungshandbuch Implantate und Instrumente“ UH 1100.
1 Bestimmungsgemäßer Gebrauch
uCentum ist ein Implantatsystem zur dorsalen operativen Stabilisierung, Fixierung und Korrektur der ausgewachsenen menschlichen Brust-
und Lendenwirbelsäule, gegebenenfalls unter Einschluss des Sakrums.
2 Produktbeschreibung
Das uCentum System besteht aus Pedikelschrauben, Stäben, Querstabilisatoren, Osetverbinder, Pedikelhaken und Laminahaken. Die Pedikel-
schrauben können polyaxial, monoaxial, vorklemmbar oder als Langkopfschraube ausgeführt sein und sind in unterschiedlichen Durchmes-
sern und Längen verfügbar. Alle Schraubenvarianten können dabei frei kombiniert und teilweise mit den gleichen Instrumenten verwendet
werden. Ferner können die Pedikelschrauben kanüliert oder nicht kanüliert ausgeführt sein. Die kanülierten Pedikelschrauben können über
einen Führungsdraht platziert werden. Kanülierte Pedikelschrauben mit einer Perforation an der Schraubenspitze erlauben eine Zementaug-
mentation. Die uCentum Stäbe haben einen Durchmesser von 6,0 mm, sind gerade oder vorgebogen ausgeführt und in unterschiedlichen
Längen verfügbar. Zur Vervollständigung der Instrumentierung besteht die Möglichkeit verschiedene Größen von Querstabilisatoren, Oset-
verbindern und Haken zu verwenden. Das uCentum System ist zur bilateralen Instrumentierung vorgesehen und kann sowohl oen als auch
perkutan angewendet werden.
3 Indikationen
Das uCentum Implantatsystem ist bei folgenden Erkrankungen indiziert:
Degenerative Bandscheibenerkrankung
Deformität
Spinaler Tumor
Spondylolisthese
Fehlgeschlagene vorangegangene Fusion
Pseudarthrose
Spinalstenose
Destruktion
Instabilität
4 Kontraindikationen
In folgenden Fällen sollte keine Implantation mit dem uCentum System standen:
Patienten mit Fieber oder Leukozytose bei nicht Wirbelsäule-assoziierten Infektionen
Patienten mit Metallallergie
Patienten mit einer Neigung zu Fremdkörperreaktionen
5 Mögliche Nebenwirkungen
Mögliche Komplikationen, die mit dem Implantat einhergehen können, sind:
Implantatlockerung, -dislokation und/oder Implantatversagen
Lokale oder systemische Reaktionen auf Grund einer Materialunverträglichkeit
Ausbleiben der knöchernen Fusion
2019-05-06

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Zementleckagen nach Augmentation mit Zement
Anschlussdegeneration von Nachbarsegmenten
Diese möglichen Komplikationen können weitere operative Eingrie (Implantatentfernung oder Erneuerung der Stabilisierung) zur Folge
haben. Sonstige Komplikationen, die durch das operative Verfahren an sich und unabhängig vom Implantat entstehen können, sind:
Allgemeine operationsbedingte Gefahren und Komplikationen
Narkoserisiken, Bluttransfusionsrisiken, Lagerungsschäden
Lungenkomplikationen
Infektion
Wundheilungsstörung
Kardiovaskuläre Komplikationen wie z. B. Blutverlust,Thrombose, Embolie, Gerinnungsstörung
Gastrointestinale Komplikationen wie z. B. Gastritis, Ileus, Ulcus
Neurologische Komplikationen wie z. B. Rückenmarks- oder Nervenwurzelläsionen mit vorübergehenden oder bleibenden sensorischen
und/oder motorischen Beeinträchtigungen (Blasen- und Mastdarmstörungen, Sexualfunktionsstörungen)
Intraoperative Verletzung von Gefäßen, Massenblutung, Hirnschlag, Hirnblutung mit potentiell lebensbedrohlichen Folgen
Verletzung von Nachbarorganen der Wirbelsäule wie Halseingeweide, Brust- und Bauchorgane je nach operierter Region
6 Warnhinweise und Vorsichtsmaßnahmen
6.1 Allgemein
Der Anwender muss sicherstellen, dass die aktuellenVersionen der als Gesamtdokumentation zum System bereitgestellten vollständigen
Produktmaterialien vorliegen und berücksichtigt werden. Diese sind zudem verfügbar unter: www.ifu.ulrichmedical.com. Auf Anfrage
kann ein gedrucktes Exemplar innerhalb von 7Tagen geliefert werden.
Dieses Produkt darf nur von einem in der Wirbelsäulenchirurgie erfahrenen Arzt unter sterilen Bedingungen in einem Operationssaal mit
Bildwandler verwendet werden.
Das Produkt wird unsteril geliefert und muss vor der ersten Anwendung aufbereitet werden. Die Anleitung zur Aufbereitung bendet sich
in dem als Teil der Gesamtdokumentation zum System bereitgestellten„Aufbereitungshandbuch Implantate und Instrumente“ UH 1100.
Der behandelnde Arzt trägt die Verantwortung für die richtige Auswahl der Patienten, das erforderliche Training mit dem System und die
Erfahrung bei der Auswahl und Platzierung von Implantaten. Ihm obliegt auch die Entscheidung, Implantate postoperativ zu belassen
oder wieder zu entfernen.
Das Produkt muss sorgfältig gehandhabt und gelagert werden. Implantate, die Beschädigungen oder Kratzer aufweisen, dürfen nicht
verwendet werden, da die Festigkeit und Ermüdungsresistenz beeinträchtigt sein können.
Implantate der entsprechenden ulrich medical Systeme sind ausschließlich mit den dafür vorgesehenen systemspezischen Instrumenten
zu verwenden, sofern nicht anderweitig angegeben.
Die Verbindung von ulrich medical Implantaten mit Implantatkomponenten anderer Hersteller ist nicht zulässig.
Für die sakrale, iliosakrale und iliakale Instrumentierung kann uCentum mit dem ulrich medical System uBase kombiniert werden. Siehe
dazu Gebrauchsanweisung uBase WS 7195. Eine Kombination mit anderen internen Fixateuren von ulrich medical innerhalb einer Inst-
rumentierung ist nicht zulässig.
Korrosion von Metallimplantaten ist aufgrund vorhandener Passivschichten sehr gering, kann jedoch zur beschleunigten Materialermü-
dung mit der Möglichkeit eines Materialbruches sowie zur Zunahme der in den Körper abgegebenen Metallbestandteile führen. Korrosion
wird begünstigt durch die Berührung von Komponenten aus unterschiedlichen Metallen sowie durch eine Beschädigung der Implanta-
toberäche. Die Kombinierbarkeit der in diesem System zum Einsatz kommenden Metallimplantate wurde sichergestellt. Ein direkter
Kontakt mit Metallimplantaten anderer Hersteller ist nicht zulässig.
6.2 Präoperativ
Bei den folgenden Fällen sollte eine Implantation von uCentum nur nach sorgfältiger fachärztlicher Abwägung erfolgen:
Patienten mit einem ungünstigen medizinischen oder psychologischen Allgemeinzustand, der durch den Eingri weiter verschlechtert
werden könnte.
Schwangerschaft.
Patienten mit Obesität (erhöhteWahrscheinlichkeit des Implantatversagens).
Rauchern (erhöhte Rate von Pseudarthrosen).
Patienten mit mangelnder Tragfähigkeit der vorderen Wirbelsäule falls keine weiteren Maßnahmen zur Stabilisierung der vorderen
Wirbelsäule vorgenommen werden können.
Eine Implantation ist erst dann in Betracht zu ziehen, wenn alle anderen Behandlungsmöglichkeiten sorgfältig abgewogen und nicht als
besser erkannt worden sind. Selbst ein erfolgreich implantiertes Implantat ist dem oder den gesunden Bewegungselement(en) der Wir-
belsäule unterlegen. Umgekehrt kann ein Implantat für den Patienten ein vorteilhafter Ersatz für ein oder mehrere schwer veränderte(s),
degenerierte(s) Bewegungselement(e) sein, weil damit Schmerzen beseitigt und eine guteTragfähigkeit erreicht werden kann.
2019-05-06

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Der Patient ist über die Risiken des Eingris und des Implantateinsatzes, einschließlich gegebenenfalls notwendiger Revisionen, einge-
hend aufzuklären.
Der behandelnde Arzt sollte das mit der Verwendung dieses Implantats zu erwartende Operationsresultat, insbesondere hinsichtlich mög-
licher physikalischer Limitationen des Implantats, mit dem Patienten ausführlich besprechen. Der postoperative Aktivitätsgrad beeinusst
die Lebensdauer des Implantats und die Haltbarkeit des Implantats im Knochen. Der Patient muss daher auf Einschränkungen und Gefah-
ren bei täglichen Aktivitäten und auf besondere Verhaltensregeln hingewiesen werden. Der behandelnde Arzt muss abschätzen, ob der
Patient die Anordnungen verstehen und befolgen kann. Besondere Aufmerksamkeit sollte auf eine postoperative Besprechung und die
Notwendigkeit regelmäßiger medizinischer Kontrollen gelegt werden.
Die korrekte Implantatwahl und -platzierung ist durch den prä-, intra- und postoperativen Einsatz geeigneter diagnostischer Verfahren
sicherzustellen bzw. zu überprüfen.
Fehler in der Auswahl des Implantats können zu vorzeitigem klinischen Implantatversagen führen. Die Anzahl der zu versorgenden Seg-
mente ist sorgfältig zu bestimmen. Der menschliche Knochen beschränkt durch seine Form und Beschaenheit die Größe und Wider-
standsfähigkeit des Implantats.
6.3 Intraoperativ
Für die Auswahl des Schraubentyps ist zu beachten, dass die polyaxialen Schrauben sich in der Flexibilität der Freiheitsgrade am Schrau-
benkopf auszeichnen. Monoaxiale Schrauben hingegen sind den polyaxialen Schrauben in der mechanischen Stabilität überlegen.
uCentum darf nur für eine bilaterale Instrumentierung eingesetzt werden.
uCentum Pedikelschrauben sind vorgesehen für die Implantation in der thorakalen, lumbalen und sakralen Wirbelsäule (T1-S1). Pedikel-
schrauben dürfen in S1 nur konvergierend implantiert werden.
Das Biegen der Stäbe darf ausschließlich mit den im System dafür vorgesehenen Biegeinstrumenten erfolgen. Zurückbiegen und/oder
wiederholtes Konturieren gerader Stäbe, sowie das Biegen vorgebogener Stäbe ist nicht zulässig.
Die Osetverbinder CS 3812-01-015, -030 und -060 dürfen nur wie folgt verwendet werden: nicht am Ende einer reinen uCentum Instru-
mentierung und bei Platzierung von uCentum in S1 nur in Kombination mit einer lliosakralschraube aus uBase.
Nachdem das Implantat einmal eingesetzt worden ist, darf es nicht wiederverwendet werden und muss entsorgt werden. Selbst wenn
das Implantat äußerlich unverändert erscheint, können vorangegangene Belastungen Beschädigungen verursacht haben, die zu einem
Implantatversagen führen können.
6.4 Postoperativ
Der Patient sollte angewiesen werden, seinen behandelnden Arzt unverzüglich über ungewöhnliche Veränderungen im Operationsbereich
zu informieren.
Der Patient soll überwacht werden, falls eine Veränderung im instrumentierten Bereich aufgefallen ist. Der behandelnde Arzt soll die
Möglichkeit eines klinischen Implantatversagens bewerten und mit dem Patienten die erforderlichen Maßnahmen besprechen, die zur
weiteren Heilung beitragen.
Das eingesetzte Implantat dient der internen Fixierung und Stabilisierung der Operationsstelle während eines maximal 2-jährigen Hei-
lungsprozesses. Nachdem die Wirbelsäule fusioniert ist, haben die Implantate keinen funktionellen Zweck mehr. Eine Explantation ist
generell möglich und sollte aber erst nach sorgfältiger fachärztlicher Abwägung bezüglich des Risikos gegenüber dem Nutzen durch-
geführt werden.
Falls das Implantat nach Erfüllung seines bestimmungsgemäßen Gebrauchs oder einer verzögerten Heilungsphase (keine Fusion inner-
halb von 2 Jahren) nicht entfernt wird, können eine oder mehrere der folgenden Komplikationen auftreten:
1. Korrosion, mit lokaler Gewebeentzündung oder Schmerzen
2. Migration des Implantats, möglicherweise resultierend inVerletzungen
3. Risiko von zusätzlichenVerletzungen verursacht durch ein postoperativesTrauma
4. Verbiegungen, Lockerungen oder Brüche, die das Entfernen schwierig oder unmöglich machen
5. Schmerzen, Beschwerden oder ungewöhnliche Empndlichkeit aufgrund des Vorhandensein des Implantats
6. Risiko der Infektion oder Entzündung
7. Knochenschwund aufgrund von Stress Shielding
8. Potentiell unbekannte oder unerwartete Langzeiteekte
Sowohl auftretende Knochenresorption als auch ein Trauma können das Implantat nach der Implantation übermäßig belasten und zu
Implantatversagen führen.
Die Implantatentfernung sollte entsprechend postoperativ nachversorgt werden, um Frakturen oder andere Komplikationen zu vermeiden.
Explantierte Implantate dürfen nicht wiederverwendet werden.
Der Patient sollte über die nach der Implantation notwendigen Verhaltensanweisungen, einschließlich der Maßnahmen, die bei einem
Vorkommnis mit dem Implantat zu treen sind, aufgeklärt werden. Ein Implantatpass ist dem Patienten auszuhändigen.
2019-05-06

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7 Empfohlene Anwendung
Die weitergehende Beschreibung der Anwendung von uCentum ist in der als Teil der Gesamtdokumentation zum System bereitgestellten
OP-Technik enthalten und zudem verfügbar unter www.ifu.ulrichmedical.com.
8 Materialinformation
Die uCentum Implantate sind aus einer Titanlegierung gemäß ISO 5832-3 und ASTM F136 hergestellt. Aus Kobaltchrom gemäß ISO 5832-12
und ASTM F1537 hergestellt: CS 3812-400 Stab, Kobaltchrom, Ø 6,0 mm, gerade, Länge 400 mm, Sechskant, Standardzugang.
Die Produkte sind gemäß EN ISO 10993-1 biokompatibel, korrosionsbeständig und nicht toxisch im vorgesehenen Anwendungszweck.
9 MRT Information
MR
ulrich medical uCentum Implantate sind als„MR conditional“ gemäß Norm ASTM F2503 eingestuft.
Die„MR conditional”Komponenten wurden nach den ASTM Normen: F2052; F2182; F2213 und F2119 getestet. Ein Patient mit einem uCentum
Implantat kann unter folgenden Bedingungen im MRT untersucht werden:
Feldstärken von 1,5 T und 3,0 T
höchster Feldgradient von 30T/m (3.000 G/cm) oder weniger
maximale spezische Absorptionsrate (SAR) von 2 W/kg für den Normal Operating Mode
bei 1,5 T: Abstand von Implantat Außenkante zum Isozentrum des MR-Gerätes > 20 cm UND Scanzeit von maximal 30 min
bei 3,0 T: Abstand von Implantat Außenkante zum Isozentrum des MR-Gerätes > 20 cm ODER Scanzeit von maximal 15 min
Hinweis: Im experimentellen Test wurden bei 3,0 T bei 15 Minuten Scanzeit mit 2W/kg 6,1 °C Erwärmung gemessen. Bei 1,5 T mit 20 cm
Abstand zum Isozentrum bei 15 Minuten Scanzeit wurde eine maximale Erwärmung von 3,0 °C gemessen. Unter diesen Scanbedingungen
kann ein Patient risikoarm untersucht werden. Um die Erwärmung gering zu halten, sollte die Scanzeit so kurz wie möglich und die SAR so
gering wie möglich gehalten werden.
Artefakte: Die MR Bildgebung im Bereich der Implantate kann durch Artefakte gestört werden. Im experimentellen Test ergaben sich Arte-
fakte bis zu 28 mm radial um das Implantat. Die Scans wurden mit folgenden Parametern durchgeführt:
FFE Sequenz: TR 100 ms, TE 15 ms, ip angle 30°
SE Sequenz: TR 500 ms, TE 20 ms, ip angle 70°
Die SE Sequenz zeigt reduzierte Artefakte (≤ 17 mm).
Eine sorgfältige Risiko-/Nutzenbewertung ist durch den behandelnden Arzt vorzunehmen.
10 Verpackung und Lagerung
Das Produkt wird unsteril geliefert und muss vor der ersten Anwendung aufbereitet werden. Bevor ein System verwendet wird, sollten alle
Komponenten sorgfältig auf Vollständigkeit, Schäden und Mängel überprüft werden. Beschädigte Komponenten dürfen nicht verwendet
werden.
Instrumente können bei Lagerung unter ungünstigen Bedingungen korrodieren. Um dies zu vermeiden, sind diese trocken und staubgeschützt
zu lagern. Damit sich auf den Instrumenten keine Feuchtigkeit (Kondensat) bildet, sind größere Temperaturschwankungen zu vermeiden.
Chemikalien können im direkten Kontakt Metall zerstören oder Dämpfe abgeben, die korrosiv wirken. Instrumente dürfen daher nicht zusam-
men mit Chemikalien gelagert werden.
Für die Lagerung der Implantate und Instrumente sind die zum System gehörenden Lagerungssiebe zu verwenden.
11 Identikation und Rückverfolgbarkeit
Implantate sind mit Artikel- und Lotnummer auf demVerpackungslabel und, soweit technisch machbar, auf dem Implantat selbst gekennzeichnet.
Um die Rückverfolgbarkeit zu gewährleisten, müssen diese Daten entsprechend in der Klinik dokumentiert werden.
12 Entsorgung gebrauchter Produkte
Zur Entsorgung von gebrauchten Medizinprodukten beachten Sie bitte die länderspezischen Regelungen zur Entsorgung von Klinikmüll.
13 Reinigung, Desinfektion und Sterilisation
Das Produkt wird unsteril geliefert und muss vor der ersten Anwendung aufbereitet werden.
Für die Reinigung, Desinfektion und Sterilisation von unsterilen Implantaten und Instrumenten ist das in der Gesamtdokumentation zum
System bereitgestellte„Aufbereitungshandbuch Implantate und Instrumente“ UH 1100 zu verwenden. Für einzelne Instrumente, die in der
systembezogenen OP-Technik entsprechend markiert sind, müssen die in der Gesamtdokumentation zum System bereitgestellten„Montage-
und Demontageanleitungen mit speziellen Reinigungshinweisen“ beachtet werden.
Diese sind zudem verfügbar unter: www.ifu.ulrichmedical.com.
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14 Kennzeichnung und Symbole
Artikelnummer Fertigungslosnummer, Charge Menge
Hersteller Herstellungsdatum Achtung
Bei beschädigter Verpackung
nicht verwenden Nicht wiederverwenden NON
STERILE
Nicht steril
Montage- und Demontageanleitung mit speziellen Reinigungshinweisen
beachten Gebrauchsanweisung beachten
CE-Kennzeichnung mit Identikationsnummer der Benannten Stelle
MR
Bedingt MR sicher – ein
Produkt, das unter spezizierten
Auagen keine wissentlichen
Gefährdungen im spezischen
MR-Umfeld aufzeigt
Achtung: Gemäss US-Bundesgesetz darf dieses Produkt nur an Ärzte oder auf
deren Anordnung verkauft werden
2019-05-06

WS 3895-eIFU
R8.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
7
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the user to ensure that the most up-to-date IFU is used.
SYSTEM: uCentum™ comprehensive posterior system
LANGUAGE: English The only version applicable to users in the U.S. is the version intended especially for the
UnitedStates.
Read all instructions carefully. Failure to follow instructions, warnings and precautionary measures
may have severe consequences or result in patient injury.
Take into careful consideration all product materials before clinical use.
The required product materials prepared as overall documentation of the system are: system related
instructions for use, surgical technique and, if applicable, supplements, assembly and disassembly
instructions, as well as "Processing manual implants and instruments" UH 1100.
1 Intended use
uCentum is an implant system for the posterior surgical stabilization, xation and correction of the mature human thoracic and lumbar spine,
including the sacrum if necessary.
2 Product description
The uCentum system consists of pedicle screws, rods, crosslinks, oset connectors, pedicle hooks and lamina hooks. Pedicle screws may be
engineered as polyaxial, monoaxial, pre-xation or longarm screws and are available in various diameters and lengths. All screw variants may
be used in free combinations and some with the same instruments. Moreover, pedicle screws are designed in cannulated or not cannulated
forms. Cannulated pedicle screws may be placed by means of a guidewire. Cannulated pedicle screws with a perforation on the tip of the screw
permit cement augmentation. uCentum rods have a diameter of 6.0 mm, are straight or pre-curved, and available in dierent lengths. Dier-
ent sizes of crosslinks, oset connectors and hooks may be used in order to achieve completion of the instrumentation process. The uCentum
system is to be used for bilateral instrumentation and may be applied using either an open or percutaneous approach.
3 Indications
The uCentum implant system is indicated for the following diseases:
Degenerative disc disease
Deformity
Spinal tumor
Spondylolisthesis
Failed prior fusion
Pseudoarthrosis
Spinal stenosis
Destruction
Instability
4 Contraindications
In the following cases an implantation of uCentum should not be performed:
Patients with fever or leukocytosis with non-spine associated infections
Patients with a history of metal allergy
Patients who tend to react to foreign bodies
5 Possible side eects
Possible complications associated with the implant are:
Implant loosening, dislocation and/or implant failure
Local or systemic reactions due to material intolerance
Failure of bony fusion
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Cement leakage following augmentation with cement
Adjacent segment degeneration
These possible complications may lead to further surgical interventions (implant removal or stabilization renewal). Other complications
caused by the surgical procedure itself and independent of the implant are:
General surgical risks and complications
Anesthesia and blood transfusion risks as well as positioning damage
Lung complications
Infection
Wound healing disorders
Cardiovascular complications, such as blood loss, thrombosis, embolism, coagulopathy
Gastrointestinal complications, such as gastritis, ileus, ulcer
Neurological complications, such as spinal cord or neural root lesions with temporary or permanent sensory and/or motor disturbances
(bladder and rectal disorders, sexual dysfunction)
Intraoperative injury to blood vessels, massive hemorrhage, stroke, cerebral hemorrhage with potential life-threatening consequences
Injury to organs adjacent to the spine, such as cervical, thoracic and abdominal organs, depending on the region operated on
6 Warnings and precautions
6.1 General
The user has to ensure that the most current versions of the complete product materials provided as overall documentation of the system are on
hand and considered.These are also available at: www.ifu.ulrichmedical.com. A printed copy may be delivered within 7 days, upon request.
This product must be used only by an experienced spine surgeon, under sterile conditions and in an operating room where C-arm is available.
The product is delivered non-sterile and must be sterilized before rst use. Instructions for processing can be found in the "Processing manual
implants and instruments" UH 1100, prepared as part of overall documentation of the system.
The treating physician is responsible for making the proper selection of patients, and for acquiring the training with the system and
experience required for implant selection and placement.The treating physician is also responsible for determining whether to leave the
implant following surgery or to remove it.
The product must be carefully handled and stored. Implants with any kind of damage or scratches must not be used, as product stability
and resistance to fatigue may be aected.
Implants in corresponding ulrich medical systems must be used exclusively with system-specic instruments intended for this purpose,
unless otherwise indicated.
Connecting ulrich medical implants to implant components of other manufacturers is not permitted.
uCentum can be combined with ulrich medical uBase system for sacral, iliosacral and iliac instrumentation. For more information, consult
instructions for use uBase WS 7195. A combination with other internal xators from ulrich medical within an instrumentation is not permitted.
Given the presence of passive layers, corrosion of metal implants is very minimal. Nevertheless, there may be accelerated material fatigue
and the possibility of a break, as well as increased release of metal components in the body. Corrosion is promoted by the components
made of dierent metals coming into contact and by damage to the implant’s surface.The ability to combine the various metal implants
used in the system has been assured. Direct contact with metal implants from other manufacturers is not allowed.
6.2 Preoperative
In the following cases an implantation of uCentum should only be performed after carefully weighing by a medical specialist:
Patients who are in a generally unfavorable medical or psychological condition which could be worsened by the procedure.
Pregnant patients.
Obese patients (higher risk of implant failure).
Smoking patients (higher rate of pseudarthrosis).
Patients with insucient load bearing of the anterior spine if no further measure to stabilize the anterior spine could be performed.
Implantation should only be considered when all other treatment options have been carefully weighed and ruled out. A successful implant
is also inferior to the healthy moving element(s) of the spine. On the other hand, an implant may be an ecient replacement of one or
more severely deformed or degenerated moving elements in order to eliminate pain and achieve good load bearing capacity.
The risks of the procedure and the use of the implant, including any revisions which may be necessary, should be explained to the patient in detail.
The treating physician should conduct with the patient a detailed discussion of the surgical results that may be anticipated, particularly
with regard to potential physical limitations of the implant. The degree of postoperative activity aects the life time of the implant and
the stability of the implant in the bone. Thus, the patient must be informed of the limitations and risks inherent in daily activities and
made aware of special guidelines for movement. The treating physician must assess whether the patient can understand and follow such
instructions. Special attention should be given to postoperative discussion and the need for regular medical monitoring.
Ensure that suitable pre-, intra- and postoperative diagnostic procedures are performed to evaluate and ensure proper implant selection
and placement.
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
Errors in implant selection could result in premature clinical implant failure. The number of segments to be treated must be accurately
determined.The shape and composition of human bones limits the size and durability of the implant.
6.3 Intraoperative
When selecting the screw type, it should be noted that the polyaxial screws are distinguished by the exibility of the degrees of freedom
on the screw head. Monoaxial screws, by contrast, are superior to polyaxial screws with regard to mechanical stability.
uCentum should only be used for bilateral instrumentation.
uCentum pedicle screws are appropriate for implantation in the thoracic, lumbar and sacral vertebrae (T1-S1). Pedicle screws may only be
implanted in S1 in a convergent manner.
The rods should only be bent using the bending instruments in the system intended for this purpose. Bending back and/or repeated
contouring of straight rods, as well as bending of curved rods, is not permitted.
The CS3812-01-015, -030 and -060 oset connectors should only be used in the following manner: not at the end of a pure uCentum instru-
mentation and, when uCentum is placed in the S1 segment, they must be inserted exclusively combined with an iliosacral screw from uBase.
After insertion, the implant must not be reused and must be disposed of. Even if the exterior of the implant appears unchanged, prior
stress may have caused damage that can lead to implant failure.
6.4 Postoperative
The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where
the surgery was performed.
The patient should be monitored for any changes to the implant area. The treating physician should assess the potential for clinical
implant failure and discuss with the patient the necessary measures to promote further healing.
The implant serves to promote internal xation and stabilization of the surgical area over a maximum two-year healing process. The
implants serve no functional purpose after the spine has fused. Implant removal is generally feasible, but should only be performed after
a meticulous risk to benet assessment by a medical specialist.
One or more of the following complications may occur, should the implant not be removed after its intended use or after a prolonged
healing phase (no fusion within 2 years):
1. Corrosion, with local tissue inammation or pain
2. Implant migration, possibly leading to injuries
3. Risk of additional injuries, caused by post-surgical trauma
4. Deections, loosening or breaks, making removal dicult or impossible
5. Pain, symptoms or unusual sensitivity due to the presence of the implant
6. Risk of infection or inammation
7. Bone loss due to stress shielding
8. Potential, unknown or unexpected long-term eects
After implantation, the occurrence of bone resorption and trauma may excessively strain the implant, thus leading to implant failure.
Implant removal should be followed by appropriate postoperative care in order to avoid fractures or other complications.
Explanted implants must not be reused.
The patient should be informed about the necessary behavior after the implantation procedure, including measures to be taken in case of
an event involving the implant. An implant card should be given to the patient.
7 Recommended application
Further description of the uCentum application is included in the surgical technique, prepared as part of the overall documentation of the
system. It is also available at www.ifu.ulrichmedical.com.
8 Material Information
The uCentum implants are manufactured from a titanium alloy according to ISO5832-3 and ASTM F136. Made of CoCr according to ISO5832-12
and ASTM F1537: CS3812-400 Rod, CoCr, Ø 6.0 mm, straight, length 400 mm, hex end, standard approach.
The devices are biocompatible, corrosion-resistant and non-toxic in the intended use as per EN ISO10993-1.
9 MRI Information MR
ulrich medical uCentum implants are classied as "MR Conditional" according to ASTM standard F2503.
The "MR Conditional" components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a uCentum
implant can undergo an MRI examination under the following circumstances:
eld strengths of 1.5T and 3.0 T
highest eld gradient of 30T/m (3000 G/cm) or less
maximum specic absorption rate (SAR) of 2W/kg for normal operating mode
at 1.5T: Distance from outer edge of implant to the iso-center of the MRI device > 20 cm AND scan time of a maximum of 30 min
2019-05-06

10
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
at 3.0T: Distance from outer edge of implant to the iso-center of the MRI device > 20 cm OR scan time of a maximum of 15 min
Note: Under experimental conditions, 6.1°C heating was measured at 3.0 T and with a 15-minute scan time at 2 W/kg. At 1.5 T with a 20-cm
distance from the iso-center with a 15-minute scan time, 3.0°C maximum heating was measured. These scan conditions allow low-risk exami-
nation of patients.To minimize heating, the scan time should be as short as possible and the SAR should be kept as low as possible.
Artifacts: MR imaging in the area of the implants can be impaired by artifacts. In the test, artifacts up to 28 mm were detected radially around
the implant.The scans were performed with the following parameters:
FFE sequence:TR 100 ms,TE 15 ms, ip angle 30°
SE sequence:TR 500 ms,TE 20 ms, ip angle 70°
The SE sequence showed reduced artifacts (≤ 17 mm).
The attending physician should conduct a careful risk/benet assessment.
10 Packaging and storage
The product is delivered non-sterile and must be sterilized before its rst use. Before a system is used, all components should be meticulously
checked for completeness, damages and defects. Damaged components must not be used.
Corrosion may occur when instruments are stored under unfavorable conditions. In order to avoid this, they should be stored in a dry, dust-free
area. Signicant temperature uctuations are to be avoided, so that no moisture (condensation) accumulates on the instruments.
When directly exposed to metal, chemical substances may destroy this metal or release corrosive fumes. Therefore, instruments must not be
stored together with chemical substances.
The system-specic trays are to be used to store the implants and instruments.
11 Identication and traceability
Implantsarelabeledwiththe catalogue number and batch code on the packaginglabel and, if technically feasible, these are marked on the implant itself.
To ensure traceability, these data must be correspondingly documented in the hospital.
12 Disposal of used products
Follow country-specic regulations regarding disposal of hospital waste when disposing of used medical devices.
13 Cleaning, disinfection and sterilization
The product is delivered non-sterile and must be sterilized before its rst use.
For cleaning, disinfection and sterilization of non-sterile implants and instruments the "Processing manual implants and instruments"
UH1100 that was provided in the overall documentation of the system must be used. For individual instruments which are correspondingly
marked in the surgical technique, the "Assembly and disassembly instructions with special cleaning instructions" that was provided in the
overall documentation of the system have to be considered.
These are also available at: www.ifu.ulrichmedical.com.
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
14 Labeling and symbols
Catalogue number Batch code Quantity
Manufacturer Date of manufacture Caution
Do not use if package is
damaged Do not re-use NON
STERILE
Non-sterile
Consult assembly and disassembly instructions with special cleaning
instructions Consult instructions for use
CE mark with identication number of the notied body
MR
MR Conditional – A product
which does not demonstrate
any deliberate hazards in the
specic MRI environment
Caution: U.S. federal law restricts this device to sale by or on the order of a
physician
2019-05-06

WS 3895-eIFU
R8.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
12
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
SYSTEM: uCentum™ comprehensive posterior system
COUNTRY: USA
!Rx only BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND THE
SYSTEM-RELATED SURGICAL TECHNIQUES!
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER: DISTRIBUTED IN THE USA BY:
ulrich GmbH & Co. KG ulrich medical USA Inc.
Buchbrunnenweg 12 18221 Edison Avenue
89081 Ulm | Germany Chestereld MO 63005 | USA
GENERAL INFORMATION
Please ensure that you are using and observing the most current instructions for use and surgical technique of this system at all times.
These can be downloaded any time free of charge at: www.ifu.ulrichmedical.com
A printed copy will be provided upon request.
DESCRIPTION
uCentum™ comprehensive posterior system is used to provide stabilization, xation and correction of the thoracic and lumbar regions of the
spine, including the sacrum if necessary. The system components include rods, polyaxial screws and a rod-to-rod crosslink. These implant
components can be assembled in a variety of congurations such that treat each construct may be tailored to the individual case.
uCentum™ pedicle screws are available cannulated and non-cannulated.The cannulated screws can be used with guide wires. Final tightening
of the screw eliminates the polyaxial function and provides rigid stability. However, by loosening the locking screw, the surgeon can regain
the polyaxial ability.
Pedicle screws may only be implanted in S1 in a convergent fashion.
Notice:The implantation of the uCentum™ system should be performed only by experienced spinal surgeons with specic training in the use of
this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon treating the
patient bears the responsibility for the correct choice of patients, the required training and the experience with choosing and administering
implants. A copy of the surgical technique manual for the implantation of uCentum™ can be obtained free of charge by contacting ulrich
medical USA at the address or phone number given at the end of this document or via the internet at http://www.ulrichmedicalusa.com/
contact.
MATERIAL INFORMATION
uCentum™ is manufactured from titanium alloy (Ti-6Al-4V ELI) according to ISO 5832-3 and ASTM F136.
The materials are biocompatible, corrosion-resistant, and non-toxic under biological conditions.
MR MRI information
ulrich medical uCentum implants are classied as“MR conditional“ according to ASTM standard F2503.
The“MR conditional“ components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a uCentum
implant can undergo an MRI examination under the following conditions:
Field strengths of 1.5T and 3.0 T
Highest eld gradient of 30T/m (3000 G/cm) or less
Maximum specic absorption rate (SAR) of 2W/kg for normal operating mode
at 1.5T: Distance from outer edge of implant to the isocenter of the MRI device > 20 cm AND Scan time of a maximum of 30 min
at 3.0T: Distance from outer edge of implant to the isocenter of the MRI device > 20 cm OR Scan time of a maximum of 15 min
Note: In the experimental test, heating of 6.1°C was measured at 3.0 T and a 15-minute scan time at 2 W/kg. At 1.5 T with a 20-cm distance
to the isocenter with a 15-minute scan time, heating of 3.0°C maximum was measured.
2019-05-06

13
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
Under these scan conditions, the risks to the patient during an examination are low. To minimize heating, the scan time should be as brief as
possible and the SAR should be kept as low as possible.
Artefacts: MR imaging in the area of the implants can be impaired by artefacts. In the experimental test, there were artefacts up to 28 mm
radially around the implant.
The scans were performed with the following parameters:
FFE sequence:TR 100 ms,TE 15 ms, ip angle 30°
SE sequence:TR 500 ms,TE 20 ms, ip angle 70°
The SE sequence demonstrates reduced artefacts (≤ 17 mm).
The attending physician should conduct a careful risk/benet assessment.
INDICATIONS FOR USE
The uCentum™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion
of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum™ is intended for the
following indications: degenerative disc disease (as dened by back pain of discogenic with degeneration of the disc conrmed by patient
history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis),
fracture, spinal tumor, pseudarthrosis and failed previous fusion.
CONTRAINDICATIONS
Patients with acute infection, whether supercial or deep
Observed bone defects of the anterior spine without additional anterior bridging
Patients with fever or leukocytosis
Patients with spine associated infections (e.g. spondylodiscitis)
Patients with documented material allergy or tendency for reactions to foreign bodies
Patients with acute supercial and deep infection
Patients with a poor general medical or psychological condition which could be further exacerbated by the intervention; in these patients
the attending surgeon must carefully weigh the risks and benets
Patients with insucient bone mass or bone quality, e.g. severe osteoporosis, osteopenia, osteomyelitis
Patients who are pregnant
Any condition not described in the Indications for Use
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be understood by the surgeon and explained to the patient. These warnings are important
considerations particular to metallic internal xation devices. General surgical risks should also be explained to the patient prior to surgery.
The safety and eectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with
poor bone quality (e.g., osteoporosis, osteopenia).This device is intended only to be used with saline or radiopaque dye.
This product is only to be used by a surgeon experienced in spinal surgery.
Responsibility for the proper selection of patients, adequate training, experience in the choice and placement of implants rests with the
surgeon.
The patient is to be instructed carefully as to the risks involved in the implantation of the uCentum™ system. The surgeon should discuss the
expectations of surgery inherent in the use of the product with the patient also with respect to the physical limitations of the product. Post-
operative activities inuence the duration of the implant and its durability in the bone.The patient must therefore be advised regarding the
risk involved in everyday activities and regarding the appropriate behavior. The physician’s instructions are to be strictly obeyed. Particular
attention should be given to a discussion postoperatively and the necessity for periodic medical follow-up.
Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level,
other patient conditions, etc. which may impact on the performance of the system.
Selection of the correct implant and its placement is to be observed carefully applying the appropriated radiological technique, before,
during and after surgery. Errors in implant selection and position could result in premature clinical implant failure.
Failure to use the appropriate product for the application may result in a clinical failure. The implant is to be used in the anatomically cor-
rect position in compliance with currently valid standards for internal xation. The features and quality of human bone limit the size and
resistance of the implant. Without successful fusion, no implant can resist long term biomechanical forces. Even in the case of complete
bone fusion, bending, breakage or loosening of the implant components can occur.
Careful handling and storage of the product is required. Scratching or damage to the component can signicantly reduce the strength and
fatigue resistance of the product.
2019-05-06

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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
The rods should only be bent using the bending instruments in the system intended for this purpose. Bending back and/or repeated con-
touring of straight rods, as well as bending of curved rods is not permitted.
Delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening,
bending, cracking or fracturing.
The safety and eectiveness of pedicle screw spinal systems have been established only for spinal conditions with signicant mechanical
instability or deformity requiring fusion with instrumentation. These conditions are signicant mechanical stability or deformity of the
thoracic, lumbar and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolis-
thesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and eectiveness of these devices for any other conditions are unknown.
A successful result is not always achieved in every surgical procedure. In spine surgery, there are many extenuating circumstances which
may compromise the results. This device system is not intended to be the sole means of spinal support. Implants can break when subjected
to the increased loading associated with delayed or non-union. Use of this product without bone graft or in cases that result in a non-union
will not be successful.
Careful preoperative, intraoperative and postoperative planning is important in the successful utilization of the system by a surgeon. In
addition, the proper selection and compliance of the patient will greatly aect the results.
Use uCentum™ components only with other uCentum™ components; do not use with components from any other spinal system or manu-
facturer. As with all orthopedic implants, none of the uCentum™ system components should ever be reused under any circumstances.
Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level,
other patient conditions, etc. which may impact on the performance of the system.
Implants are single use only. Once the implant has been used, it must not be used again. Even if the implant appears undamaged, previ-
ous strain may have resulted in irregularities that could shorten the implant life. Only new, undamaged implants may be used. Used or
potentially damaged implants must be discarded.
A prolonged healing phase, unsuccessful bone fusion or subsequent bone resorption or trauma can place undue stress on the implant,
which, in turn, could lead to loosening, deformation, cracks or breakage of the implant.
COMPLICATIONS
In many cases, possible complications are caused by use rather than the implant:
General risks and complications from the operation
Wound healing impairment
Infection
Cardiovascular complications such as: cardiac arrest, pulmonary heart disease, pulmonary embolism, anemia, blood loss, thrombosis, em-
bolism, coagulation disorder
Lung complications such as: pneumothorax, hematothorax, chylothorax, pulmonary atelectasis
Gastrointestinal complications such as: gastritis, stress ulcers, intestinal obstruction, ulcers
Neurological complications such as: spinal cord lesions or nerve-root lesions with transitory or permanent sensory and/or motor impairments
Anesthetic risks, blood transfusion risks, positioning damage
Intraoperative vascular injuries, massive bleeding (hemorrhage)
Absence of bone fusion and necessity for renewed stabilization
Implant removal or renewed stabilization due to loosening, dislocation and/or failure of the implant
Local or systemic reactions due to material intolerances
Insucient subjective improvement in symptoms
Special risks and possible complications
Injury to the nervous structures with temporary or permanent sensory and/or motor damage.
Injury to the retro-pharyngeal structures caused by excessive perforation of the anterior cortex.
Impairment of the muscles caused by inappropriate preparation of wound closure.
Adjacent segment degeneration
USE OF GENUINE PRODUCTS / COMBINATION WITH OTHER SYSTEMS
Unless indicated otherwise system-specic instruments are to be used exclusivlely for the implantation of ulrich medical implants.
Components of ulrich medical system should not be used with components of any other system or manufacturer.
DISPOSAL OF USED MEDICAL DEVICES
Please note the country-specic regulations regarding disposal of hospital waste when disposing of used medical devices.
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
CLEANING, DISINFECTION AND STERILIZATION - IMPLANTS
Basic principles
The implants are supplied non-sterile and must be thoroughly cleaned, disinfected and sterilized before use (clean and disinfect after
removing the transport packaging and sterilize after removing the primary packaging). Implants that have already come into contact with a
patient or have become contaminated must not be used again under any circumstances; these must be discarded. Clean/disinfect implants
which you have touched, return them to the implant storage tray and sterilize the implant storage tray when it is fully loaded. Please also
follow the legal regulations which apply in your country as well as the hygiene regulations of the medical practice and/or hospital.
Cleaning and disinfection
For cleaning and disinfection of the implants, a mechanized process (disinfector) should be used whenever possible. A manual method – even
when using an ultrasound cleaning bath – is considerably less eective and should only be used when a mechanical procedure is not available.
The implants must be removed from the sterilization tray during cleaning/disinfection!
Manual
When choosing the cleaning agent and disinfectant to be used, care must be taken that
it is thoroughly suitable for cleaning and disinfection the implants,
the cleaning agent is suitable for ultrasonic cleaning (no generation of lather)
the disinfectant possesses approved eectiveness (e.g., FDA clearance) and is compatible with the cleaning agent used, and
the chemicals used are compatible with the implants (see section“material stability”).
A combined cleaning/disinfectant should not be used if at all possible.
Manual brushing is not permitted due to risk of damaging the implant surface.
The concentrations of the cleaning agent and disinfectant and application times stipulated by the manufacturer of must be adhered to without
fail.When rinsing, only use freshly produced solutions, sterile or nearly sterile (maximum 10 bacteria/ml) and endotoxin free (maximum 0.25
endotoxin units/ml) water is used (e.g., puried water/ highly puried water).When drying, use only ltered air.
Pre-cleaning
Disassemble movable parts or joints prior to pre-treatment. Rinse the products under running water. Remove supercial impurities with a soft
plastic brush; products containing lumen rinse appropriately (at least 5 times) with water and using a syringe.
Cleaning:
Immerse the products for 5 min into the 104°F warm freshly prepared cleaning solution (e.g. Cidezyme LF) and intensively clean them
with a soft plastic brush. Thoroughly rinse (at least 5 times) products containing lumen at the beginning and end of the brush cleaning
with cleaning solution. Then carefully rinse (at least 3 times for one minute) those products with sterile, deionized water using a syringe.
Disinfection:
Soak the products for 12 min in a disinfection solution. (e.g. Cidex OPA).Thoroughly rinse (at least 5 times) products containing lumen at
the beginning and end of the brush cleaning with disinfection solution. Then rinse the products suciently (at least 3 times) with sterile,
deionized water. Flush lumen using a sucient amount of sterile, deinoized water (at least 100 ml) and a syringe.
Automated cleaning and disinfection
When choosing the disinfector, care must be taken that
the disinfector possesses approved eectiveness (e.g., FDA clearance),
if possible, an approved program for thermal disinfection is used (10 minutes minimum at 93°C (199.4°F) or A0value > 3000). Chemical
disinfection involves the risk of disinfectant residues on the implants,
the program used for the implants is suitable and includes sucient rinsing cycles,
during rinsing, only water which is sterile or nearly sterile (maximum 10 bacteria/ml) and endotoxin free (maximum 0.25 endotoxin units/
ml) is used (e.g., puried water/ highly puried water),
the air used for drying is ltered and
the disinfector is regularly maintained and checked.
When choosing the cleaning system to be used, care must be taken that
it is thoroughly suitable for cleaning the implants,
if thermal disinfection is not used, a suitable disinfectant with approved eectiveness (e.g., FDA clearance) is used and that this is compat-
ible with the cleaning agent used
the chemicals used are compatible with the implants (see section“material stability”).
The concentrations of the cleaning agent and disinfectant stipulated by the manufacturer of must be adhered to without fail.
Procedure:
Place the implants onto the disinfector. Take care to ensure that the implants remain untouched.
Start the program
Remove the implants from the disinfector once the program has ended.
Inspect and pack the implants immediately after removal from the disinfector or if necessary, after additional drying has take place at
a clean location (see section“inspection”and“packaging”).
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
The implants were determined to be thoroughly suitable for eective mechanical cleaning and disinfection (disinfector G7836 CD, Miele
Professional, Princeton NJ) by an independent testing laboratory using the following parameters for the cleaning and disinfection phase.
Process step Description Parameters
Pretreatment (rinsing) Rinsing temperature 10 +/-2°C
Treatment time 1 min.
Solution cold water
Cleaning Cleaning temperature 40 +/-2°C
Treatment time 5 min.
Cleaning solution Sekumatic FR
Concentration 0.3% (3ml/l)
Neutralization Neutralization temperature 10 +/-2°C
Treatment time 2 min.
Neutralizer Sekumatic FNZ
Concentration 0.1% (1ml/l)
Follow-up treatment (rinsing) Rinsing temperature 10 +/-2°C
Treatment time 2 min.
Solution deionized water
Thermal disinfection Disinfection temperature 93 +/-2°C
Treatment time 10 min.
Solution deionized water
Inspection
Inspect all implants for damage and contamination and reject any implants that are damaged and contaminated.
Packaging
Sort and put away all cleaned and disinfected implants into the implant storage tray provided and pack these into suitable sterilization
packaging (FDA cleared, disposable sterilized packaging with single or double wrap and/or sterilization containers) having the following
requirements:
Correspond to ANSI AAMI 11607
Are suitable for steam sterilization (minimum temperature of 141 °C (286°F), permitting sucient steam penetration
Provides sucient protection of the implants and sterilized packaging from mechanical damage
For the sterilization containers, has regular maintenance in accordance with manufacturer’s guidelines
CLEANING, DISINFECTION AND STERILIZATION – INSTRUMENTS
ulrich instrument processing instructions
ulrich GmbH & Co. KG ulrich medical USA
Buchbrunnenweg 12 l 89081 Ulm l Germany 18221 Edison Avenue
Telefon/Phone [phone] Chestereld, MO 63005 USA
Phone: [phone], Fax: [phone]
VALID IN THE FOLLOWING COUNTRY: USA
PROCESSING
Basic principles
All instruments, including the sterilization layers and trays, must be thoroughly cleaned, disinfected and sterilized before each use; this applies
especially to the rst-time use after delivery because all instruments are shipped in non-sterile condition (clean and disinfect after removing
the transport packaging and sterilize after packaging). Eective cleaning and disinfection is an indispensable prerequisite for eective
sterilization. When using instruments, please make sure to keep dirty instruments separate and do not place them back into the instrument
tray in order to prevent serious contamination of the equipped instrument tray. Clean/disinfect the dirty instruments, sort them and place
them back in the instrument tray, then sterilize the entire equipped instrument tray. Within the scope of your responsibility for instrument
sterility, please ensure that only cleaning/disinfection and sterilization processes which have been appropriately validated in a device-
specic and product-specic manner are used, that the employed devices (disinfecting machine, sterilizer) undergo regular maintenance
and inspections and that the validated parameters are complied with during each cycle. In addition, please follow all applicable laws in your
country as well as the hygiene regulations of the medical practice or hospital in question.This applies especially to the various requirements
regarding eective prion inactivation.
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
Instruments intended for one-time use may not be reprocessed.
CLEANING AND DISINFECTION
Basic principles
Use a mechanical procedure (disinfecting machine) to clean and disinfect the instruments, when possible. Because a manual procedure is
considerably less eective and reproducible (even when using an ultrasonic bath), it should only be used when a mechanical procedure is
unavailable. Instruments must be taken out of the trays for cleaning and disinfecting!
Pretreatment
Pretreatment must be done for both mechanical and manual processes. Major impurities must be removed from the instruments directly after
use (within max. 2 hours). Use running water or a disinfectant for this; the disinfectant should be aldehyde-free (otherwise xation of blood
impurities could occur), be demonstrably eective (e.g. FDA clearance), be suitable for instrument disinfection and be compatible with the
instruments (see the„Material stability“ section). To remove impurities manually, use only a soft brush or a clean, soft cloth which you use
exclusively for this purpose; never use a metal brush or steel wool.
Move moveable parts, such as push-buttons/release buttons or hinges, during the preliminary cleaning.
If applicable: Rinse all the lumina of the instruments ve times using a disposable syringe (minimum volume: 50 ml).
The disinfectant used during pretreatment is only intended for personal protection and does not replace the subsequent disinfection step
after successful cleaning.
Mechanical cleaning/disinfection of instruments
When selecting a disinfecting machine, please ensure that:
The disinfecting machine features proven evidence of ecacy, (e.g. FDA clearance);
If possible, a tested thermal disinfection program should be used (A0value > 3000, or, for older devices, at least 10 minutes at 93 °C [199
°F]) (chemical disinfection runs the risk of leaving disinfectant residues on the instruments);
The used program is suitable for the instruments and contains sucient rinsing cycles;
The water used (e.g., puried water/highly puried water) for rinsing is sterile or nearly sterile (no more than 10 microbes/ml) and low in
endotoxins (no more than 0.25 endotoxin units/ml).
Filtered air is used for drying; and
The disinfecting machine undergoes regular maintenance and inspections.When selecting a cleaning agent system, please ensure that:
It is suitable for cleaning the instruments;
If no thermal disinfection is used – a suitable disinfectant with proven ecacy (e.g. FDA clearance) is additionally used and that it is
compatible with the employed cleaning agent;
The manufacturer‘s concentrations and application times for the cleaning agent and/or disinfectant are strictly complied with.
Process for mechanical cleaning/disinfection of instruments
1. Disassemble the instruments according to the manufacturer‘s instructions.
2. Place the disassembled instruments into the disinfecting machine. Place the instruments which, according to the manufacturer‘s instructions, do
not need to be disassembled entirely into the disinfecting machine. Make sure that the instruments do not touch each other.
3. Close all lumina of the instruments (using a suitable ush adapter) on the disinfectant machine‘s ush connection.
4. Open instruments with hinges in order to minimize contact of the components amongst themselves. Fixate the hinges with spring mechanism
with the corresponding tools, if necessary.
5. Start the program.
6. Remove the instruments from the disinfecting machine after the program has nished. Ensure that the instruments are dry after cleaning/disin-
fection. If necessary, subject the instruments to additional drying in a clean location.
7. Check and package the instruments as soon as possible after removal (see the„Inspection,“„Maintenance“ and„Packaging“ sections).
Manual cleaning/disinfection of instruments
Combined cleaning agents/disinfectants should only be used in the event of extremely little initial impurity (no visible impurities) of the
instruments.
Process for manual cleaning of instruments
1. Disassemble the instruments according to the manufacturer’s instructions.
2. Place the disassembled instruments into the cleaning bath for the specied application time so that the instruments are suciently immersed (if
necessary, use ultrasound or carefully clean with a soft brush). Place the instruments which, according to the manufacturer’s instructions, do not
need to be disassembled entirely into the cleaning bath for the specied application time so that the instruments are suciently immersed (if
necessary, use ultrasound or carefully clean with a soft brush). While doing so, ensure that the instruments do not touch each other.
3. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable syringe
(minimum volume: 50 ml), a suitable ush adapter and a sterilization agent and disinfectant for ultrasonic cleaning.
4. Clean the instruments in the ultrasonic bath (35 to 40kHz) for 5 minutes.
5. Remove the instruments from the cleaning bath and rinse them thoroughly (at least 1 minute) under running water.
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
6. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable syringe
(minimum volume: 50 ml).
7. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run o completely. If necessary, subject the instruments to ad-
ditional drying in a clean location.
8. Inspect the instruments (see the„Instrument inspection“ and „Maintenance“ sections).
Instrument disinfection during manual cleaning
1. Place the disassembled and non-disassembled (see manufacturer‘s instructions), cleaned and inspected instruments into the disinfecting bath for
the specied application time so that the instruments are suciently immersed. Make sure that the instruments do not touch each other.
2. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable syringe
(minimum volume: 50 ml).
3. Remove the instruments from the disinfecting bath and rinse them thoroughly (at least 1 minute) under running water.
4. If applicable: Rinse all the lumina of the instruments using a disposable syringe (minimum volume: 50 ml).
5. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run o completely. If necessary, subject the instruments to ad-
ditional drying in a clean location.
6. Package the instruments as soon as possible after removal (see the„Packaging“ section).
Instrument inspection
Inspect all the instruments, including the sterilization layers and trays, after cleaning or cleaning/disinfecting for corrosion, damaged surfaces,
chips and impurities and separate out all damaged instruments. Instruments that are still dirty must be cleaned and disinfected again.
Maintenance
Reassemble all disassembled instruments. Subject all instruments to a functional test. Apply instrument oil to all moveable parts such as
push-buttons, sliding sleeves, closures on tongs, latches, threaded spindles, etc. for maintenance purposes. Instrument oils should not be used
other than for the above purpose whenever possible. Only instrument oils (white oil) should be used which – taking into consideration the
maximum applied sterilization temperature – are approved for steam sterilization and feature proven biocompatibility.
As a rule, no oil may be applied to silicone parts.
Packaging
Sort the cleaned and disinfected instruments and place them into the proper instrument tray and package them in suitable sterilization
packaging (i.e., FDA cleared sterilization wrap).
STEAM STERILIZATION – IMPLANTS & INSTRUMENTS
The implants and instruments have been found to be thoroughly suitable for eective steam sterilization by an independent accredited
laboratory using the following parameters.Validation was performed during the half-cycle. Only the following sterilization procedure is to be
used. Other sterilization procedures are not permitted.
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure time: 4 min.
Drying time: minimum 30 min.
Testing has shownthese parameters to result in a sterility assurance level (SAL) of 10-6. Do not use hot-air sterilizationorradiationsterilization
procedures. Do not stack implant and/or instrument trays. Flash sterilization is not permissible under any circumstances!
Storage
After sterilization, the implants and instruments must be stored in the sterilization packaging dry and free of dust.
Material stability
When choosing the cleaning agent and disinfectant, please ensure that they do not contain the following ingredients:
Corrosion protectors/corrosion inhibitors (triethanolamine is particularly problematic)
Strong organic, mineral and oxidizing acids
Strong alkaline solutions (pH > 12 is not permissible for implants, pH > 10.5 is not permissible for aluminum trays; neutral or weakly
alkaline cleaning agents are recommended)
Solvents (alcohols, acetone), benzine
Oxidizing agents
Ammonias
Chlorine and iodine
Never clean implants, implant trays and sterilization containers with metal brushes or wire wool.
No implants, implant storage trays or sterilization containers may be exposed to temperatures higher than 141°C (286 °F).
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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
PATIENT INSTRUCTIONS AND POSTOPERATIVE MEDICAL CARE
The risks of the procedure and the use of the implant as well as possible risks due to any revisions which may be necessary should be explained
to the patient in detail.The surgeon should discuss what the expected results of using this product are with the patient in detail, in particular
with regard to possible physical limitations of the product and limitations in physical activities after implantation with the product. The post-
operative degree of activity inuences the lifespan of the implant and the durability of the implant in the bone.The patient must therefore
be instructed about restrictions and risks of daily activities and any special rules of behavior. The doctor‘s instructions are to be complied with
implicitly. Particular attention should be given to postoperative discussion and the necessity for regular medical examination.
PRODUCT COMPLAINTS:
Any dissatisfaction with the product quality, labelling or performance should be reported to ulrich medical USA immediately by the customer
or health care provider. Furthermore, if any of the implants „malfunction,“ (i.e., do not meet any of their performance specications or
otherwise do not perform as intended) and may have caused or contributed to the death or serious injury of the patient ulrich medical USA
should be notied immediately by telephone, fax, or written correspondence.When ling a complaint, the name, part number and lot number
of the part should be provided along with the name and address of the person ling the complaint.
HIGHLIGHTING AND SYMBOLS
Catalogue number !Caution!
Qty.
Quantity
Lot code Single use only NON
STERILE Non-sterile
Use-by date Do not use if package
is damaged Consult the instructions for use
Manufacturer Temperature limit Sterilization by irradiation
Date of manufacture
Caution: Federal law restricts
this device to sale by or on the
order of a physician
MR MR conditional
Consult assembly and
disassembly instructions with
special cleaning instructions
CE mark with identication
number of the Notied Body
For additional information and product complaints, please contact:
ulrich medical USA
18221 Edison Avenue
Chestereld, MO 63005
Phone: [phone]
Fax: [phone]
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WS 3895-eIFU
R8.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
20
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU.The onus resides with
the user to ensure that the most up-to-date IFU is used.
SYSTÈME: uCentum™ comprehensive posterior system
LANGUE: Français
La version spécique aux États-Unis n’est valable que pour les utilisateurs américains.
Veuillez lire attentivement l’ensemble des consignes. Le non-respect des consignes, avertissements et
mesures de précaution peut avoir de graves conséquences ou occasionner des lésions au patient.
Avant tout usage clinique, prenez connaissance de tous les documents liés au produit.
Les documents incontournables faisant partie de la documentation générale liée au produit sont: le mode
d’emploi du système, la technique chirurgicale et ses suppléments éventuels, les consignes de montage et
de démontage ainsi que le « Manuel de traitement implants et instruments »UH1100.
1 Utilisation prévue
uCentum est un système d’implant destiné à la stabilisation chirurgicale postérieure, la xation et la correction du rachis lombaire et thora-
cique chez l’adulte, y compris du sacrum si nécessaire.
2 Description du produit
Le système uCentum comprend des vis pédiculaires, des tiges, des connecteurs transverses, des connecteurs décalés, des crochets pédicu-
laires et des crochets lamaires. Les vis pédiculaires peuvent être polyaxiales, monoaxiales, de préxation ou tulipes et existent en plusieurs
diamètres et longueurs. Tous les types de vis peuvent être librement combinés, certains avec les mêmes instruments. En outre, les vis pédi-
culaires peuvent être canulées ou non. Les vis pédiculaires canulées peuvent être placées à l’aide d’un l-guide. Les vis pédiculaires canulées
présentent une perforation au niveau de la pointe, cela permet de pratiquer une cimentoplastie. Les tiges uCentum présentent un diamètre
de6,0mm, elles sont droites ou précintrées et existent en diérentes longueurs. Vous pouvez utiliser des connecteurs transverses, des connec-
teurs décalés et des crochets de diérentes tailles pour l’implantation du matériel. Le système uCentum s’utilise pour l’implantation bilatérale
de matériel et peut être appliqué en voie d’abord ouverte ou percutanée.
3 Indications
Le système d’implant uCentum est indiqué pour les maladies suivantes:
Discopathie dégénérative
Malformation
Tumeur rachidienne
Spondylolisthésis
Échec d’une arthrodèse préalable
Pseudarthrose
Sténose du canal rachidien
Destruction
Instabilité
4 Contre-indications
L’implantation d’uCentum est contre-indiquée dans les cas suivants:
Patients présentant une èvre ou une hyperleucocytose causée par une infection non rachidienne
Patients présentant des antécédents d’allergie aux métaux
Patients présentant une sensibilité aux corps étrangers
5 Possible eets secondaires
Les complications possibles liées à l’implant sont:
Descellement, dislocation et/ou rupture de l’implant
Réactions locales ou systémiques du fait d’une intolérance aux matériaux
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