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anglais vers croate: Norian Drillable Bone Void Filler
Texte source - anglais IMPORTANT INFORMATION
ON THE
NORIAN DRILLABLE™ BONE VOID FILLER
DESCRIPTION
Norian Drillable Bone Void Filler is an injectable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable Bone Void Filler is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.
Norian Drillable Bone Void Filler is provided in a sterile pouch (“Rotary Pouch”).
The rotary pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The rotary pouch contains sterile powder (calcium phosphate with absorbable polylactide/glycolide co-polymer fibers) and is designed with an injection port for the purpose of adding the mixing solution (dilute sodium phosphate with sodium hyaluronate) to the pouch. The mixing solution is contained in the solution syringe (“Solution Syringe”), which is packaged separately.
The rotary pouch is designed to be placed in an automatic reusable mixer (“Rotary Mixer”) where the two components are mixed together [outside the sterile field] to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Drillable Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Bone Void Filler is slowly resorbed and replaced with bone during the healing process.
INDICATIONS
Norian Drillable Bone Void Filler is intended for bony voids or defects of the skeletal system. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Norian Drillable Bone Void Filler can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium that provides partial structural support during the healing process and allows for early load bearing. Norian Drillable Bone Void Filler is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process.
CONTRAINDICATIONS
Norian Drillable Bone Void Filler is not intended for use in spinal applications and should not be used in the presence of active or suspected infection.
Norian Drillable Bone Void Filler is not for use in:
Patients with traumatic open injuries that are predisposed to infection
Full load bearing applications without the use of stabilizing hardware.
Areas where adjacent bone is avascular, or is incapable of supporting or anchoring the implanted rigid fixation hardware.
Patients with compromised health (e.g. abnormal calcium metabolism, metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic deficiencies or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site.
Patients who are skeletally immature.
Intra-articular space (i.e., material placed into the joint space).
WARNINGS
Norian Drillable Bone Void Filler should not be resterilized
Norian Drillable should be implanted within 5 minutes after mixing. Discard any unused material.
If more than one rotary pouch is required the total volume (not to exceed 40cc) of Norian Drillable Bone Void Filler should be implanted within the 2-minute implantation time.
The effect of layering Norian Drillable Bone Void Filler is not known
Do not add any additional substances to Norian Drillable
Do not remove any hardware until after the device has cured for 24 hours
Highly pressurized application of Norian Drillable into a tightly confined space with ready venous or arterial access is not recommended, as the potential for formation of emboli is unknown.
Norian Drillable is provided sterile. If integrity of the package is compromised, the product must be assumed non-sterile and appropriately discarded.
Do not use if temperature indicator is black
Conditional Restrictions
The effect of Norian Drillable Bone Void Filler on patients with the following indications or conditions is not known:
Individuals who will not or cannot follow a prescribed rehabilitation course such as with alcohol or drug abusers
Defects due to congenital malformation or metabolic disease
Documented renal disease
Pregnancy and/ or nursing women
Cardiovascular disease precluding elective surgery
Patients having received or to receive chemotherapy or radiation therapy at or near the implant site
PRECAUTIONS
The long-term effects of extraosseous or intra-articular Norian Drillable Bone Void Filler (material placed into the joint space) are unknown. Arthritis may be a possible complication of intra-articular Norian Drillable Bone Void Filler.
Familiarity with the use of bone void fillers for filling defects in bone, and the use of Norian Drillable Bone Void Filler are required prior to treatment.
If reoperation is required, the device should be removed.
Screws placed through the material should be supported by bone on both sides of the material, according to proper orthopedic reduction technique.
The safety and effectiveness of Norian Drillable in contact with adjacent allograft, acrylic, silicone, or polymer materials has not been established.
Due to the radiopacity of the material, anomalies may not be detected.
Excess fluid accumulation following wound closure should be avoided.
Norian Drillable attains physiologic pH after components are mixed, but the components may be irritants when separate. Proper eye protection and surgical gloves should be worn when mixing or cleaning up the components. Seek medical attention if the components are ingested or inhaled. If skin or eye contact occurs, do the following and seek medical attention if irritation occurs:
Skin exposure: Wash area with soap and water.
Eye exposure: Flush thoroughly with running water.
Unused Norian Drillable Bone Void Filler should be discarded. Before disposal of a rotary pouch, mix according to the Directions for Use to render the contents pH neutral.
Placing guide wires (e.g. K-wires) through Norian Drillable Bone Void Filler may cause the material to fracture. If guide wires are to be used, it is recommended that the guide wire be inserted into Norian Drillable Bone Void Filler during the 2 minute implantation time or the 10-minute setting time. Placing guide wires through the material after the 10-minute set time has elapsed is not recommended. Monitor the K-wire position when over drilling to ensure the K-wire does not advance with the drill.
The use of self drilling screws is not recommended with Norian Drillable Bone Void Filler unless the material is pre-drilled to the root diameter of the screw.
As with most materials, placing screws near the edge of the implanted Norian Drillable Bone Void Filler may cause the Bone Void Filler to fracture.
The use of cannulated screws with thread diameter greater than 5.0mm over a guide wire is not recommended.
Handling
Norian Drillable Bone Void Filler is packaged in a rotary pouch (“Rotary Pouch”) that includes the compartment for the powder with an integral injection port and delivery syringe (see Figure 1). The solution syringe (“Solution Syringe”) containing the mixing solution is separately packaged along with the rotary pouch.
FIGURE 1: Norian Drillable Rotary Pouch for Rotary Mixer
The Norian Drillable Bone Void Filler rotary pouch is supplied sterile and non-pyrogenic. Do not open the package until ready to use. Examine the package for damage before using the sterile bone substitute, as damage might impair sterility. Do not attempt to re-sterilize the unused contents of an opened package, but dispose of it. This applies to both the inner primary and the outer secondary peel-off package. Do not use Norian Drillable after expiration of the use-by date printed on the package.
Surgical Technique
Before using Norian Drillable Bone Void Filler the surgeon should develop a preoperative plan. This requires understanding the method, sequences, and estimated volume of Norian Drillable Bone Void Filler needed to fill the void.
1.Prepare Implant Site: Remove blood clots and tissue debris; lavage and/or suction instruments may be used. Control active bleeding. Prepare the void by compacting the cancellous bone with a curette elevator or similar instrument.
2.Mix: Use the Rotary Mixer to mix the rotary pouch.
PRECAUTION: Norian Drillable Bone Void Filler rotary pouch should be equilibrated to 18°- 23°C/ 64-73F
Rotary Mixer - Power Operation
1.Unwrap the power cord and connect to an appropriate hospital grade outlet. Once connected, the “Standby” indicator will illuminate indicating that the unit is ready for operation.
2.Open the lid by depressing thumb latch on right corner of lid surface.
3.Position the rotary pouch on the mixer by aligning the arrows on the rotary pouch and mixer.
4.Press the pack over the center post of the mixer.
5.Inject the solution into the rotary pouch using aseptic technique.
Note: Once the solution has been injected into the rotary pouch, the remaining steps must be completed immediately.
6.Remove the pouch clip from the rotary pouch and unfold with the Delivery Syringe to the right.
7.Close the lid and secure by depressing the thumb latch.
8.Depress the “Start” button. A single brief beep will be heard, the Standby indicator will turn off and the “Mixing” indicator will illuminate.
9.After 70 revolutions, the mixing cycle is complete. An extended beep will be heard and the “Mix Complete” indicator will slowly flash. The Rotary Mixer will continue to beep every five seconds until the lid is opened.
PRECAUTION: If the Rotary Mixer fails to complete the mixing cycle, or the lid is opened before the cycle is complete, an audible alarm will sound and all function indicators will flash. Using a new rotary pouch, return to step 2 or mix using Manual Operation (see below) with a new rotary pouch.
Manual Operation
1.Follow steps 2 - 6 above.
2.Lift up on the manual handle and rotate the top disk 70 revolutions clockwise.
Instructions for Transfer - Powered and Manual Operation
1.Open the lid and lift the mixed rotary pouch from the center post.
2.Guide the pack and turn the knob counterclockwise to feed the rotary pouch into the transfer rollers. The material will be expelled from the mixing chamber into the Delivery Syringe.
3.Once the material is completely transferred, turn the transfer knob clockwise to remove the rotary pouch.
4.Using aseptic technique, grasp the sides of the outer pouch and peel back at the Delivery Syringe to separate outer packaging and expose it.
5.Present the Delivery Syringe to the Scrub Nurse.
Note: The 5-minute Preparation Time and the 2-minute Implantation Time described below are not sequential. The 2-minute Implantation Time begins when material injection is initiated, which must occur within the 5-minute Preparation Time.
3.Preparation Time (5 minutes at room temperature, 18-23C / 64-73F):
Attach the Delivery Needle. Norian Drillable Bone Void Filler remains injectable for 5 minutes.
Injection of the Bone Void Filler should be performed under direct visualization or under real time image intensification. If obstruction of the needle occurs, the needle should be discarded and replaced with a new needle.
Insert the needle into the operative site and begin to deliver the Norian Drillable Bone Void Filler.
PRECAUTION: If the Preparation Time (5 minutes from end of mixing process) elapses, the remaining Norian Drillable Bone Void Filler that has not been implanted must be discarded.
4.Implantation Time (2 minutes at body temperature, 37C / 98.6F):
Norian Drillable Bone Void Filler is intended to be placed into bony voids either before or after final fixation.
At body temperature (37C / 98.6F), Norian SRS Bone Void Filler begins to set approximately 2 minutes following implantation and may be considered set 10 minutes after implantation is completed.
PRECAUTION: If more than one rotary pouch is required, the total volume (not to exceed 40cc) of Norian Drillable Bone Void Filler should be implanted within the 2-minute Implantation Time.
PRECAUTION: Do not overfill defects and remove excess material
5.Setting Time 10 minutes at body temperature, 37C / 98.6F:
The material can be drilled and tapped, and screws can be placed through it at any time after injection. When placing screws into Norian Drillable Bone Void Filler, it is recommended that a hole be pre-drilled to the root diameter of the screw.
Proceed slowly and irrigate while drilling through Norian Drillable Bone Void Filler. Clear excess material from flutes of drill. After drilling or tapping through material, lightly irrigate to remove excess debris.
PRECAUTION: Placing guide wires (e.g. K-wires) through Norian Drillable Bone Void Filler may cause the material to fracture. If guide wires are to be used, Synthes recommends that the guide wire be inserted into Norian Drillable Bone Void Filler during the 2-minute implantation time or the 10-minute set time. Placing guide wires through the material after the 10-minute set time has elapsed is not recommended.
PRECAUTION: Do not place self-drilling screws through the material without pre-drilling to the root diameter of the screw.
PRECAUTION: Norian Drillable Bone Void Filler should not be used as a screw anchor. Screws placed through the material should be supported by bone on both sides of the material, according to proper orthopedic reduction technique
Release the tourniquet, if used, and gently irrigate Norian Drillable with warm saline to return the operative site to core body temperature.
At body temperature (37C / 98.6F), Norian Drillable Bone Void Filler may be considered set 10 minutes after implantation is completed.
Note: If the material has not set in 30 minutes, remove it and start over with a new rotary pouch.
6.Cure Time (24 hours at body temperature, 37C / 98.6F): Norian Drillable Bone Void Filler reaches its ultimate compressive strength by 24 hours.
Storage
Keep the sterile bone substitute in its protective package in a dry place at 5-25°C. Exposure during transit may exceed this range. Product that exceeds 42°C during transit (as shown by the temperature dot turning black) must be discarded.
Caution
Sufficient experience in the field of the use of biomaterials is highly recommended before using Norian Drillable.
Keep away from Sunlight
Keep Dry
Store between 5°C and 25°C.
Manufactured by:
Norian Corporation
A Synthes Company
1230 Wilson Drive
West Chester, PA 19380 USA
Distributor:
Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
EU Authorized Representative:
Synthes GmbH
Im Kirchenhürstle 4-6
79224 Umkirch
Germany
Norian Drillable™ is a trademark of Norian Corporation.
Traduction - croate NORIAN DRILLABLETM BONE VOID FILLER
SREDSTVO ZA PUNJENJE ŠUPLJINA U KOSTIMA
OPIS
Norian Drillable Bone Void Filler je biokompatibilno sredstvo za punjenje šupljina u kostima. Sadrži ojačana vlakna i primjenjuje se injekcijom. Norian Drillable Bone Void Filler sredstvo za punjenje šupljina u kostima primjenjuje se prije ili poslije konačnog fiksiranja. Materijal se može bušiti i kuckati, a vijci se mogu postaviti u svako doba za trajanja ili po završetku procesa skrućivanja. Po završetku skrućivanja, sastav smjese je vrlo sličan mineralnoj fazi kosti.
Norian Drillable Bone Void Filler dolazi u sterilnoj vrećici (Rotary Pouch).
Rotary Pouch se sastoji od vanjske vrećice od prozirne folije i od unutarnje vrećice od laminirane folije, za koju je pričvršćena šprica. Rotary Pouch sadrži sterilni prašak (kalcijev fosfat s apsorbabilnim poliaktidno-glikolidnim kopolimernim vlaknima). Rotary Pouch ima injekcijski otvor, kroz koji se u vrećicu dodaje otopina za miješanje (razrijeđeni kalijev fosfat s kalijevim hijaluronatom). Otopina za miješanje se nalazi u šprici za otopinu (Solution Syringe), koja je pakirana posebno.
Rotary Pouch se stavlja u automatsku miješalicu za višekratnu uporabu - Rotary Mixer. Tu se dvije komponente miješaju (izvan sterilnog područja) tako da se dobije glatka, viskozna pasta. Pasta se može ubrizgavati najviše 5 minuta nakon priprave pri temperaturi od 18°–23°C (64°-73°F). Na temperaturi od 37°C(98.6°F) Norian Drillable Bone Void Filler sredstvo za punjenje šupljina u kostima počinje se skrućivati nakon 2 minute, a potpuno se skrutne za oko 10 minuta. Tijekom zacjeljivanja Norian Drillable Bone Void Filler se polako resorbira i zamjenjuje ga koštano tkivo.
INDIKACIJE
Sredstvo Norian Drillable Bone Void Filler primjenjuje se kod šupljina u kostima ili kod oštećenja koštanog sustava. To mogu biti oštećenja kostiju nastala kirurškim zahvatom ili traumatskom ozljedom kosti. Norian Drillable Bone Void Filler sredstvo za punjenje šupljina u kostima primjenjuje se kao pomoćno sredstvo, uz konvencionalnu imobilizaciju tvrdim sredstvima, tako što podržava fragmente kostiju za vrijeme kirurškog zahvata. Kad se materijal stvrdne, on djeluje kao privremena potpora za vrijeme zacjeljivanja, pri čemu se brzo mogu početi nositi tereti. Norian Drillable Bone Void Filler sredstvo za punjenje šupljina u kostima stavlja se u šupljinu u kosti za vrijeme ili po završetku procesa imobilizacije. Materijal se može bušiti ili kuckati. Vijci se mogu postavljati kroz njega za vrijeme ili po završetku procesa skrućivanja.
KONTRAINDIKACIJE
Norian Drillable Bone Void Filler sredstvo za punjenje šupljina u kostima nije namijenjeno primjeni na kralježnici. Također, ne treba ga rabiti kod akutne infekcije ili sumnje na nju.
Norian Drillable Bone Void Filler se ne primjenjuje:
kod pacijenata s traumom koji imaju predispoziciju za infekcije;
kod primjena namijenjenih nošenju punog tereta, a bez čvrste imobilizacije;
kad je susjedno koštano tkivo avaskularno ili ne podupire odnosno ne omogućuje usidravanje vijaka;
kod pacijenata s oštećenjima zdravlja (npr. abnormalni metabolizam kalcija; metabolička bolest kostiju; nedavna, a neliječena lokalna infekcija; vaskularna ili teža neurološka bolest; infekcija; imunološki nedostaci ili poremećaji sustava) koje za posljedicu imaju slabo zacjeljivanje ili moguće odumiranje tkiva na mjestu implantiranja;
kod pacijenata s nerazvijenim kosturom;
unutar zglobova.
UPOZORENJA
Norian Drillable Bone Void Filler se ne smije resterilizirati.
Norian Drillable se mora primijeniti za manje od 5 minuta nakon miješanja. Neupotrijebljeni materijal baciti.
Ako je potrebna dodatna Rotary Pouch vrećica, ukupna količina Norian Drillable Bone Void Filler (koja ne smije biti veća od 40 ccm) mora se primijeniti u roku od 2 minute.
Učinci naslojavanja Norian Drillable Bone Void Filler sredstva za punjenje nisu poznati.
Osim navedenih, sredstvu se ne smiju dodavati nikakve druge tvari.
Imobilizacijska sredstva se ne smiju odstranjivati dok nije prošlo najmanje 24 sata od primjene sredstva Norian Drillable Bone Void Filler.
Ne preporučuje se primjena Norian Drillable Bone Void Filler pod visokim tlakom, u tijesnim prostorima s pristupom krvnim žilama, jer nije poznato kolika je mogućnost stvaranja embolije.
Norian Drillable Bone Void Filler dolazi na tržište u sterilnom stanju. Ako je pakiranje oštećeno, valja pretpostaviti da proizvod više nije sterilan te ga na prikladan način odbaciti.
Ne upotrebljavati ako pokazatelj temperature pokazuje crno.
UVJETNA OGRANIČENJA
Nisu poznati učinci sredstva Norian Drillable Bone Void Filler na pacijente sa sljedećim indikacijama ili utvrđenim stanjima:
Kod osoba koje ne mogu ili ne žele slijediti propisani rehabilitacijski proces, kao što su npr. alkoholičari ili uživatelji droge.
Kod poremećaja uzrokovanih prirođenim malformacijama ili metaboličkim bolestima.
Kod dokumentiranih bolesti bubrega.
Kod trudnica i dojilja.
Kod osoba s kardiovaskularnim bolestima kod kojih nije moguće učiniti kirurški zahvat.
Kod pacijenata koji su primili ili će primiti kemoterapiju ili terapiju zračenjem na mjestu primjene sredstva ili blizu njega.
NAPOMENE I MJERE OPREZA
Dugoročni učinci primjene sredstva Norian Drillable Bone Void Filler unutar zglobova ili izvan kostiju nisu poznati. Artritis može nastati kao komplikacija nakon primjene sredstva unutar zglobova.
Prije tretmana treba općenito poznavati primjenu sredstava za punjenje šupljina u kostima te posebno primjenu Norian Drillable Bone Void Fillera.
Ako je potrebna ponovna operacija, treba ukloniti sredstvo.
Vijci koji prolaze kroz sredstvo za punjenje moraju s obje njegove strane imati potporu koštanoga tkiva, u skladu s odgovarajućom ortopedskom redukcijskom tehnikom.
Nije utvrđena sigurnost ni djelotvornost Norian Drillable Bone Void Fillera u dodiru s alograftnim, akrilnim, silikonskim i polimernim materijalima.
Kako je materijal radiološki neproziran, anomalije se u njemu rengenskim putem ne mogu otkriti.
Treba izbjegavati nakupljanje viška tekućine poslije zatvaranja rane.
Nakon spajanja komponenata Norian Drillable postiže fiziološki pH. No kad su komponente odvojene, one mogu biti iritanti. Potrebna je pravilna zaštita očiju i nošenje zaštitnih kirurških rukavica, pogotovu prilikom miješanja i čišćenja komponenata. Ako komponente dođu u dodir s ustima ili očima, treba odmah zatražiti liječničku pomoć. Ako materijal dođe u dodir s kožom ili očima, treba zatražiti liječničku pomoć te učiniti sljedeće:
koža: oprati sapunom i vodom;
oči: temeljito isprati tekućom vodom.
Norian Drillable Bone Void Filler koji je preostao nakon uporabe treba baciti. Prije nego se odbaci Rotary Pouch, promiješati komponente prema uputama za uporabu, tako da se dobije neutralan pH.
Provođenje žica za vođenje kroz Norian Drillable Bone Void Filler može prouzročiti pucanje materijala. Ako se upotrebljavaju žice za vođenje, preporučuje se njihovo umetanje u sredstvo Norian Drillable Bone Void Filler tijekom 2 minute implantacijskog vremena ili za vrijeme skrućivanja od 10 minuta. Ne preporučuje se provođenje žica za vođenje kroz materijal nakon isteka vremena skrućivanja od 10 minuta. Pažljivo pratite položaj žica za vrijeme bušenja, da se ne bi pomicale zajedno s bušilicom.
Uporaba automatskih vijaka se ne preporučuje s Norian Drillable Bone Void Fillerom, osim ako je materijal već izbušen do dimenzije vijka.
Kao i kod većine materijala, postavljanje vijaka u neposrednoj blizini implantiranog Norian Drillable Bone Void Fillera može uzrokovati njegovo pucanje.
Nije preporučljiva upotreba cjevastih vijaka s navojem koji je za 5,0 mm ili više veći od žice za vođenje.
PRIMJENA
Norian Drillable Bone Void Filler se pakira u vrećicu Rotary Pouch koja sadrži odjeljak za prašak s injekcijskim otvorom (slika 1). Šprica za otopinu za miješanje (Solution Syringe) pakirana je posebno.
Slika 1: Norian Drillable Rotary Pouch za Rotary Mixer
Norian Drillable Bone Void Filler Rotary Pouch vrećica je sterilna i nezapaljiva. Ne otvarati pakiranje dok nije sve spremno za upotrebu. Provjerite pakiranje da nema nikakvih oštećenja. Nemojte pokušavati ponovno sterilizirati neiskorišteni sadržaj jednom otvorenog pakiranja, nego ga bacite. To se odnosi kako na unutarnje, tako i na vanjsko pakiranje. Nemojte upotrebljavati Norian Drillable nakon isteka roka označenoga na pakiranju.
Kirurška tehnika
Prije upotrebe Norian Drillable Bone Void Fillera kirurg mora imati predoperativni plan. To zahtijeva poznavanje metoda i postupaka te procjenu količine Norian Drillable Bone Void Fillera za punjenje šupljine.
1. Priprema mjesta primjene: Ukloni zgrušanu krv. Mogu se upotrebljavati instrumenti za pranje ili usisavanje. Kontrolirajte aktivno krvarenje. Pripremite šupljinu zbijajući šupljikavu kost kiretom ili sličnim instrumentom.
2.Miješanje: Upotrijebite Rotary Mixer za miješanje sadržaja Rotary Poucha.
UPOZORENJE: Norian Drillable Bone Void Filler Rotary Pouch treba čuvati na temperaturi od 18°- 23°C (64-73F).
Uključivanje Rotary Mixera
1.Odmotajte upojni kabel te ga uključite u utičnicu. Zasvijetlit će pokazatelj Standby, što znači da je instrument spreman za uporabu.
2.Otvorite poklopac pritisnuvši palcem polužicu na desnoj strani poklopca.
3.Namjestite vrećicu na miješalicu poravnavši strelice na vrećici s onima na miješalici.
4.Pritisnite pakiranje na središnje izbočenje miješalice.
5.Ubrizgajte otopinu u Rotary Pouch primjenjujući aseptičnu tehniku.
Napomena: Kad je otopina jednom ubrizgana u vrećicu, preostale korake postupka treba odmah izvesti.
6.Odvojite hvataljku vrećice od vrećice i odmotajte je pomoću šprice na desnoj strani.
7.Zatvorite poklopac i zaključajte ga pritiskom palcem na polužicu.
8.Pritisnite dugme Start. Začut će se zvučni signali; pokazatelj Standby će se ugasiti, a Mixing osvijetliti.
9.Poslije 70 okretaja ciklus miješanja je završen. Začut će se produženi zvučni signal te će s prekidima svijetliti pokazatelj Mix Complete. Rotary Mixer će nastaviti davati zvučne signale svakih 5 sekundi, sve dok se poklopac ne otvori.
UPOZORENJE: Ako Rotary Mixer ne završi ciklus miješanja ili ako se poklopac otvori prije završetka ciklusa, zvučni signal će se aktivirati i sve funkcije indikatora će zasvijetliti s prekidima. Pri uporabi novog Rotary Poucha, vratite se na korak 2 ili miješajte ručno.
Ručna primjena
1.Slijedite korake 2 – 6 kao gore.
2.Podignite ručku i rotirajte gornji disk 70 puta u smjeru kazaljke na satu.
Upute za prijenos – na električni i ručni pogon
1.Otvorite poklopac i podignite vrećicu iz sredine.
2.Usmjerite pakiranje i okrenite dugme u smjeru obrnutom od smjera kazaljke na satu. Usmjerite Rotary Pouch u valjke za prijenos. Materijal će biti izbačen iz komore za miješanje u špricu za dostavu.
3.Jednom kad je materijal potpuno premješten, okrenite dugme za prijenos u smjeru kazaljke na satu da biste odstranili Rotary Pouch.
4.Pomoću aseptične tehnike uhvatite dvije strane vanjske vrećice; odlijepite mjesto gdje je šprica da biste odvojili vanjsko pakiranje i eksponirali ga.
5.Predajte tu špricu bolničarki.
Napomena: Priprema od 5 minuta i implantacija od 2 minute ne moraju biti u tom redoslijedu. Vrijeme implantacije od 2 minute počinje s početkom ubrizgavanja smjese, a to mora biti u sklopu vremena za pripremu od 5 minuta.
3.Vrijeme pripreme (5 minuta na sobnoj temperaturi od 18-23C / 6473F):
Spoji špricu za ubrizgavanje. Norian Drillable Bone Void Filler se može uporabiti najviše 5 minuta nakon pripreme.
Ubrizgavanje sredstva Norian Drillable Bone Void Filler treba obaviti uz izravan pogled ili uz pojačavanje slike u realnom vremenu. Ako igla zapne, treba je baciti i zamijeniti novom.
Umetnite iglu u područje koje tretirate i počnite ubrizgavati Norian Drillable Bone Void Filler.
Napomena: Ako vrijeme pripreme prođe (5 minuta od završetka miješanja), ostatak Norian Drillable Bone Void Fillera, koji nije uporabljen, mora se baciti.
4.Vrijeme implantacije (2 minute na tjelesnoj temperaturi od 37C /98.6F):
Norian Drillable Bone Void Filler treba ubrizgati u šupljinu bilo prije ili poslije konačne imobilizacije.
Na tjelesnoj temperaturi (37C /98.6F), Norian Drillable Bone Void Filler se počinje skrućivati otprilike 2 minute poslije implantacije i može se smatrati potpuno krutim 10 minuta poslije njezina završetka.
UPOZORENJE: Ako vam je potrebno više od jedne vrećice, ukupna količina Norian Drillable Bone Void Fillera (koja ne smije biti veća od 40 ccm) mora se uporabiti u roku od 2 minute od početka primjene.
UPOZORENJE: Ne previše puniti šupljine. Odstranite višak materijala!
5.Vrijeme skrućivanja: 10 minuta na tjelesnoj temperaturi od 37C /98.6F
Materijal se primjenjuje bušilicom ili laganim kuckanjem, a vijci se postavljaju kroz materijal u bilo koje vrijeme poslije ubrizgavanja. Kad se vijci postavljaju u Norian Drillable Bone Void Filler, preporučuje se prethodno izbušiti rupu veličine malo manju od promjera vijka.
Radite polako i ispirite za vrijeme bušenja kroz Norian Drillable Bone Void Filler. Očistite višak materijala koji se nakupio na vrhu bušilice.
UPOZORENJE: Postavljanje žica za vođenje kroz Norian Drillable Bone Void Filler može uzrokovati pucanje materijala. Ako se žele upotrijebiti žice za vođenje, «Synthes» preporučuje da se žice umetnu u Norian Drillable Bone Void Filler za 2 minute vremena za implantaciju ili u 10 minuta vremena za skrućivanje. Ne preporučuje se stavljanje žica za vođenje nakon isteka 10 minuta vremena za skrućivanje.
UPOZORENJE: Nemojte stavljati automatske vijke u materijal ako prethodno niste načinili rupu veličine promjera vijka.
UPOZORENJE: Norian Drillable Bone Void Filler se ne smije uporabiti kao sidro za vijke. Vijci koji se postavljaju kroz materijal moraju biti pričvršćeni za kost s obje strane materijala, po propisanoj ortopedskoj redukcijskoj proceduri.
Odmotajte tvrdi zavoj i polagano ispirite Norian Drillable mlakom, slanom otopinom, da bi se postigla temperatura ljudskog tijela.
Na temperaturi od 37C /98.6F Norian Drillable Bone Void Filler se smatra dovoljno krutim 10 minuta nakon početka implantacije.
Napomena: Ako se materijal nije ukrutio u roku od 30 min, zamijenite ga i počnite s novom rotacijskom vrećicom (Rotary Pouch).
6. Vrijeme za skrućivanje: 24 sata na 37C/98.6F. Norian Drillable Bone Void Filler tada postiže svoju konačnu jačinu.
Čuvanje:
Držite sterilnu koštanu zamjenu u zaštitnom paketiću na suhom mjestu na temperaturi od 5 – 25 C. Izlaganje za vrijeme prijevoza može proširiti taj raspon temperature. Proizvod koji je bio dulje izložen temperaturi većoj od 42 C za vrijeme prijevoza mora se baciti.
Upozorenje:
Snažno se preporučuje da osoba koja primjenjuje Norian Drillable Bone Void Filler ima odgovarajuće znanje na području biomaterijala prije uporabe.
Čuvati na tamnom i
suhom mjestu
na temperaturi od 5° – 25° C.
Norian Drillable™ je zaštićena robna marka tvrtke „Norian“. CE 0086
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Bachelor's degree - University of Zagreb
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Années d'expérience en traduction : 34. Inscrit à ProZ.com : Nov 2008.
Translation is not my only or even main line of work, but I take it very seriously and enjoy it a lot. When I work, I'm even more serious than on this photo. Otherwise, I'm always ready for a good laugh.
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