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.