Cartiva DRL-06 Скачать руководство пользователя страница 1

 

 

Cartiva, Inc. Document #L20-0275, Rev E 

Page 1 of 12

 

ENGLISH 
 
Cartiva

®

 SCI Instrumentation  

 
Non-sterile Instruments Instructions for Use 

 

INDICATIONS FOR USE 
 

Instrumentation supplied by Cartiva, Inc is indicated for use with implantable medical 
device products manufactured by Cartiva, Inc. 
 

CONTRAINDICATIONS 
 

Instrumentation supplied by Cartiva, Inc. is not designed, sold or intended for use other 
than as indicated. 
 

WARNINGS AND PRECAUTIONS 

 

Failure to properly clean instruments prior to sterilization may lead to inadequate 
sterilization. 

 

Surgical instruments are used with or on patients who may harbor both 
recognized and unrecognized infections. To prevent the spread of infection, all 
reusable instruments must be thoroughly cleaned and sterilized prior to initial use 
and after each patient use. 

 

Instruments may have sharp edges or features.  Users and reprocessors must 
be cautious when handling instruments.  

 
Limitations on reprocessing 

 

Repeated processing, according to these instructions, has minimal effect on and 
should not compromise the performance of reusable Cartiva

®

 instruments.  End 

of life is normally determined by wear and damage due to use. 

 

In addition to the Cartiva

®

 SCI Instrumentation that is labeled for re-use, Cartiva, 

Inc. provides single

-

use guide pins for use during the Cartiva

®

 implantation 

procedure.  Re-use of the single

-

use guide pins is strictly prohibited.  The 

material properties and reliability of these devices in a multi-use scenario ha

ve

 

not been explicitly tested or demonstrated.  Re-use of a single

-

use guide pin 

could result in improper device placement (depth, alignment, etc

.

) and undesired 

clinical outcomes. 

 

Guide Pins must be discarded after one use. 

 
Damage Inspection 

 

Inspect the instruments for damage, wear, and corrosion at all stages of 
handling. 

 

Cutting edges should be free of nicks and present a continuous edge. 

 

Check instruments with long slender features for distortion. 

 

If damage is detected, do not use instrument but consult Cartiva, Inc. for 
guidance. 

 
SPECIAL PRECAUTIONS  

Transmissible Spongiform Encephalopathy Agents 

 

It is outside the scope of this document to describe in detail the precautions that 
should be taken for Transmissible Spongiform Encephalopathy agents.   

 

The agents for transmission of Creutzfeldt-Jakob disease (CJD) are believed to 
be resistant to normal processing methods of disinfection and sterilization.  
Methods of decontamination and sterilization outlined below may not be 
appropriate where CJD transmission is a risk.   

 

Refer to the World Health Organization guidelines for a detailed listing of 
appropriate decontamination methods.   

 
INSTRUMENT DESCRIPTION 

 
This document pertains to the following instruments supplied by Cartiva, Inc.: 
  
Non-Sterile Instrumentation 

Part Description 

Instrumentation REF 

Classification 

Drill Bit 

 

(Fabricated from 455 

H900 Stainless Steel) 

DRL-06 

Reusable 

DRL-08 
DRL-10 
DRL-15 

MTD-06 
MTD-08 
MTD-10 

Introducer 

(Fabricated from 17-4 
H900 Stainless Steel) 

INT-06 

Reusable 

INT-08 
INT-10 
INT-15 

Placer 

(Fabricated from 17-4 
H900 Stainless Steel) 

PLC-06 

Reusable 

PLC-08 
PLC-10 
PLC-15 

Guide Pin 

(Fabricated from 316L 

Stainless Steel) 

PNN-02 Single 

Use 

Only 

 
Note:  All drill bits (part numbers DRL-## and MTD-##) are designed for use with 
drills having a chuck size of at least 0.25".  The drill bits are not compatible with a 6 
mm chuck. 
 
 

INSTRUCTIONS 

Post-use 

 

Remove excess soil with disposable non-shedding wipe. 

 

Instruments should be covered with a damp cloth to prevent drying of soil prior to 
cleaning. 

 
Containment and transportation 

  Observe universal precautions for handling contaminated/biohazardous 

materials. 

 

Instruments should be cleaned within 30 minutes of use to minimize the potential 
for drying prior to cleaning. 

 

Cleaning  

Preparation for cleaning 

 

No assembly/disassembly of Cartiva

®

 instruments is required unless stated on 

the device labeling. 

 

For initial and subsequent uses, follow all cleaning and sterilization instructions. 

 

Prepare a neutral pH or nearly neutral pH enzymatic detergent at the use-dilution 
and temperature recommended by the agent’s manufacturer. 

 

Cleaning agents with chlorine or chloride as the active ingredient are corrosive to 
stainless steel and must not be used.  Acidic cleaning agents should be avoided. 

 

Saline solution has a corrosive effect on stainless steel and should not be used 
to rinse, soak, or clean instruments.   

 

Cleaning Instructions  

 

Submerge the instruments in enzymatic detergent and soak for 20 minutes. 

 

While submerged in enzymatic detergent, scrub each instrument with a soft-
bristled brush, paying special attention to areas where debris might accumulate.  
Lumens and crevices should be cleaned with a long, narrow, soft-bristled brush.  
Avoid any harsh materials or cleaning motions that can scratch the surface of the 
instruments. 

 

Remove the instruments from the enzymatic detergent and rinse each instrument 
thoroughly in purified water (such as distilled or deionized water) for a minimum 
of 3 minutes.  Thoroughly flush lumens and other difficult to reach areas.  

 

Sonicate instruments for a minimum of 10 minutes in an ultrasonic cleaner 
containing fresh enzymatic detergent, preferably at 45-50 kHz (according to the 
ultrasonic unit’s directions). 

 

Remove the instruments from the enzymatic detergent and rinse each instrument 
thoroughly with purified water (such as distilled or deionized water) for at least 3 
minutes and until there is no sign of soil in the rinse stream.  Thoroughly flush 
lumens and other difficult to reach areas. 

 

Automated Cleaning  

 

Automated cleaning may not be effective at removing debris from inner lumens 
or crevices.  A manual cleaning process is recommended. 

 

Verifying Cleaning 

 

Check instruments for visible soil.  All exterior surfaces as well as inner lumens 
should be inspected.  

 

Repeat cleaning if soil is visible, and re-inspect. 

 

Disinfection 

 

Disinfection is only acceptable as an adjunct to full sterilization for reusable 
surgical instruments.  

 Disinfectant 

solution 

Cidex

®

 or equivalent may be used in accordance with 

solution supplier’s instructions.  Instruments should be thoroughly rinsed in 
purified water (such as distilled or deionized water) following disinfection. 

 

Drying 

 

Instruments with inner lumens should be agitated or positioned so that liquid 
inside the lumens may drain.   

 

Dry the exterior of the instruments with a clean, disposable, non-shedding wipe. 

 
Sterilization  

Packaging for Sterilization 

Instruments may be loaded into dedicated instrument trays or general-purpose 
sterilization trays.  The maximum load configuration, regardless of instrument size, is as 
follows: 
 

 

1 x Drill Bit (DRL-## or MTD-##) 

 

1 x Introducer (INT-##) 

 

1 x Placer (PLC-##) 

 

3 x Guide Pins (PNN-02) 

 
Use standard medical-grade steam sterilization wrap to double-wrap the tray. 

 

 

 

Содержание DRL-06

Страница 1: ...ast 0 25 The drill bits are not compatible with a 6 mm chuck INSTRUCTIONS Post use Remove excess soil with disposable non shedding wipe Instruments should be covered with a damp cloth to prevent dryin...

Страница 2: ...with Cartiva Syn e have been valida nts for initial use o processing is perfo onnel in the repro he desired result rocess Any devia y evaluated for e Designing testing n health care fa terilization of...

Страница 3: ...ebrauch Hinweis Alle Bohrspitzen Teile Nr DRL and MTD sind zur Verwendung mit Bohrfuttergr en von mindestens 0 25 Zoll vorgesehen Die Bohrspitzen sind nicht mit 6 mm Bohrfuttern vereinbar ANLEITUNGEN...

Страница 4: ...rzustellen Ger te und Mater eitungsanlage ang wird Das erforde des Arbeitsablau raufbereitungspers nachteilige Konseq igning testing and re facilities A guide zation of medical d processing of reste 0...

Страница 5: ...s no son compatibles con tiradas de 6 mm INSTRUCCIONES Despu s del uso Retire la suciedad con un pa o desechable sin hilachas Los instrumentos se deben cubrir con un pa o h medo para evitar que la suc...

Страница 6: ...astados USO se suministran jun as m s arriba han iles para el uso inic el reprocesamien el personal del alcanzar los resu ntrol de rutina de perador deber ser sas igning testing and re facilities A gu...

Страница 7: ...im tres INSTRUCTIONS Apr s l intervention Retirer l exc s de salissures avec un chiffon non pelucheux Les instruments doivent tre recouverts d un tissu humide pour viter le s chage des salissures avan...

Страница 8: ...s ont t valid non st riles pour raiteur de s assure riel appropri s et ent form de fa o dation et une surv r le retraiteur doit cons quences pote igning testing and re facilities A guide zation of med...

Страница 9: ...mandrini da 6 mm ISTRUZIONI Dopo l utilizzo Rimuovere lo sporco in eccesso con una salviettina monouso che non lasci residui Gli strumenti devono essere coperti con un panno umido prima di essere puli...

Страница 10: ...rumento smussato ite con l impianto d state approvate d mo utilizzo o il riut igenerazione veng rsonale della strut o e istruito su co alida e il monitora introdotta dal resp verificarne l efficac ig...

Страница 11: ...tir PNN 02 Tek Kullan ml k Not T m delgi u lar par a numaralar DRL ve MTD kovan ap en az 0 25 olan delgilerle birlikte kullan m i in tasarlanm t r Delgi u lar 6 mm mil ap i in uygun de ildir TAL MATL...

Страница 12: ...celenm dir nm ya da rengin entetik Kartilaj mpla Cartiva Inc taraf n z rlamaya uygun m s recinin uygun lan m birimindeki u udur Normal ar eniden kullan c lar n olas ters sonu la ir igning testing and...

Отзывы: