Johnson & Johnson DePuy Mitek GRAFT PREPARATION SYSTEM User manual

GRAFT PREPARATION
SYSTEM
P/N: 106674 Rev: F 01/11

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ENGLISH
DePuy MITEK GRAFT
PREPARATION SYSTEM
NON-STERILE – REUSABLE
DESCRIPTION
Graft Preparation Board:
Holds clamps, posts and/or fixtures in place during graft
sizing, measuring, tensioning, preparation, and assembly.
Slider Unit:
Used with the Graft Preparation Board to provide a movable
fixture for holding the Tensioning Clamp, Graft Clamp, and/
or Suture Clamp.
Tensioning Clamp:
Used with the Graft Clamp and/or Suture Clamp to hold soft
tissue or suture during graft tensioning. May be inserted
into either the Slider Unit or the Graft Preparation Board.
Tensioning Clamp consists of a tensioning body and a clamp
and may be disassembled.
Graft Clamp:
Used with the Tensioning Clamp and/or Suture Clamp to hold
soft tissue or suture during graft preparation, assembly, and
tensioning. May be inserted into either the Slider Unit or the
Graft Preparation Board.
Suture Clamp:
Used with the Tensioning Clamp and/or Graft Clamp to hold
suture during preparation, assembly, and tensioning. May be
inserted into either the Slider Unit or the Graft Preparation Board.
May be used when graft is being held and pulled by suture.
Graft Sizer:
Used to measure the size of a graft during graft preparation
and assembly. Also used with the Drill Guide to drill suture
holes into graft ends.

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Drill Guide:
Used with the Graft Sizer to drill suture holes into graft ends.
Cutting Board:
Used with the Graft Preparation Board to provide a work
surface for graft measuring, assembly, and preparation.
MATERIALS
Graft Preparation Board:
Hard Coat Anodized Aluminum and
Stainless Steel
Slider Unit, Drill Guide:
Stainless Steel
Suture Clamp:
Stainless Steel
Tensioning Clamp:
Stainless Steel and PEEK (Polyetheretherketone)
Graft Clamp:
Stainless Steel and PEEK (Polyetheretherketone)
Graft Sizer and Cutting Board:
PEI (Polyetherimide) or Polyphenylsulfone
INDICATIONS
The DePuy Mitek Graft Preparation System is intended to
prepare either soft tissue or bone-tendon grafts for Anterior
or Posterior Cruciate Ligament Reconstructive surgery.
CONTRAINDICATIONS
Other than those Indications listed above.
INSTRUCTIONS FOR USE
1. For graft tensioning and preparation use the
Graft Preparation Board, Tensioning Clamp, and
Graft Clamp or use the Graft Preparation Board,
Tensioning Clamp, and Suture Clamp (Fig.1). After initial
tension is placed in the graft, tension may be added or
subtracted by turning the knob of the Tensioning Clamp.
2. Move the Slider Units on the Graft Preparation Board by
depressing the thumb lever of the Slider Units.
3. Secure suture on the Suture Clamp by pulling suture
over the top of the Suture Clamp and then winding suture
around the rear head of the Suture Clamp.
4. Size the graft by laying the suture from the sutured graft
into the slots of the Graft Sizer and pulling the graft
through the sizing holes.

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5. Drill holes into the graft ends by placing the graft into the
Graft Sizer, placing the Drill Guide over the graft onto the
Graft Sizer, and drilling through preferred hole of the Drill
Guide.
6. Disassemble Tensioning Clamp unit prior to cleaning
and sterilization by turning rear knob counterclockwise
until the clamp disengages from the tensioner body.
Additionally, release spring compression by pushing rear
knob down and turning until stop pin is no longer seated
in initial placement pocket.
7. Tensioning Clamp may be reassembled by returning rear
knob to initial placement and re-engaging clamp with
tensioner body by turning rear knob clockwise.
PRECAUTIONS
1. Inspect for damage prior to use. Replace damaged
or worn instruments. Do not attempt to repair.
2. Care should be taken when handling the clamps to
prevent cutting or ripping surgical gloves.
CLEANING AND STERILIZATION INSTRUCTIONS
These cleaning and sterilization instructions have been
validated for preparing reusable DePuy Mitek instruments
for reuse. It is the responsibility of the end user to ensure
that the cleaning and sterilization is actually performed
using appropriate equipment, materials, and personnel to
achieve the desired result. This normally requires validation
and routine monitoring of the process. Any deviation from
these instructions should be evaluated for effectiveness and
potential adverse consequences.
PREPARATION
• Cleaninstrumentsassoonaspossibleafteruse.
If cleaning must be delayed, wet the instruments in
a compatible liquid solution to prevent drying and
encrustation of surgical soil.
• Avoidprolongedexposuretosalinetominimizethe
chance of corrosion.
• Removeexcessivesoilwithadisposablewipe.
Prior to sterilization, instruments should be cleaned by either
automated or manual means described below.

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AUTOMATED CLEANING
Instrument types with such complex design features as
cannulations, lumens, (i.e. tubes), holes, hinged joints,
box locks, spring-loaded retractable features, or flexible
shafts; must be manually pre-cleaned prior to automated
cleaning to improve the removal of adherent soil.
Manual Pre-Cleaning Instructions
• Flushinternalareaswithawarmdetergentsolution.
Pay close attention to lumens, cannulations, holes,
threads, crevices, seams, and any hard to reach areas.
While flushing, actuate any moveable mechanisms,
(hinged joints, box locks, or spring-loaded features),
to free trapped blood and debris. If the components of
the instrument can be retracted, retract or open the part
while flushing the area.
• Forinstrumentswithexibleshafts,extheinstrument
while flushing.
• Forinstrumentswithlumens,brushtheinternalsurfaces
of the lumen.
Loading Instructions
• Loadinstrumentsintowasherdisinfectorsothathinges
are open and cannulations and holes can drain.
• Placeheavierinstrumentsonthebottomofcontainers.
Do not place heavy instruments on top of delicate
instruments.
• Forinstrumentswithconcavesurfaces,suchascurettes,
place instrument with the concave surface facing
downward to facilitate draining.
Automated Cleaning Instructions
• Cleaninavalidatedwasherdisinfectorusingthe
“INSTRUMENTS” cycle and a pH neutral cleaning
agent intended for use in automated cleaning. Effective
automated cleaning can be achieved using the following
parameters: two cold water pre-washes (minimum hold of
two minutes each); a hot water enzyme wash (minimum
hold of 4 minutes); followed by a hot water pH neutral
detergent wash (minimum hold 3 minutes at 60°C); a hot
water rinse (minimum time 20 seconds); a thermal rinse
(minimum hold of 1 minute at 82.2°C) and dry (minimum
hold 5 minutes at 95°C).

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• Afterautomatedcleaning,proceedtoinspection,
instructions below.
MANUAL CLEANING
Cleaning Instructions
• Prepareanenzymaticcleaningsolutioninaccordanceto
the manufacturer’s instructions.
• Soaksoiledinstrumentsforaminimumof10minutes.
Do not exceed 30°C.
• Whencleaning,fullyimmersetheinstrumentinthe
cleaning solution to avoid aerosol generation. Use a soft
bristle brush to remove all traces of blood and debris;
pay close attention to any hard to reach areas, textured
surfaces, or crevices.When cleaning Instruments with
cannulations or lumens (i.e. tubes), or holes, use a
tight-fitting, soft, non-metallic cleaning brush or pipe
cleaner to scrub the cannula, lumen, or hole. Push in
and out, using a twisting motion to remove debris.
Use a syringe filled with enzymatic cleaning solution
to flush hard to reach internal areas. When cleaning
articulating instruments, (those with moveable parts),
brush with a soft non-metallic bristle brush to remove all
traces of blood and debris. Pay close attention to threads,
crevices, seams, and any hard to reach areas. Actuate
any moveable mechanisms, such as hinged joints,
box locks, or spring-loaded features, to free trapped
blood and debris. If the components of the instrument
can be retracted, retract or open the part while cleaning
the area. For instruments with flexible shafts, flex the
instrument under the cleaning solution.
Rinsing Instructions
Rinse the instrument thoroughly with filtered water at
38–49°C, agitate for a minimum of 1 minute; repeat rinse
at least two additional times. When rinsing, pay particular
attention to flush the cannulations, lumens, or holes with
warm tap water. Also pay particular attention to internal areas
and moveable parts. Actuate moveable parts while rinsing.
If the components of the instrument can be retracted, retract
or open the part while rinsing the area. For instruments with
flexible shafts, flex the instrument under the rinse solution.

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Drying Instructions
Dry the instrument immediately after final rinse. Use filtered
compressed air to dry internal areas. After drying proceed to
Inspection instructions.
INSPECTION AFTER CLEANING
• Inspectallinstrumentsbeforesterilizationorstorageto
ensure the complete removal of soil from surfaces, tubes
and holes, moveable parts.
• Ifareasaredifculttoinspectvisually,checkforbloodby
immersing or flushing the instrument in a 3% hydrogen
peroxide solution. If bubbling is observed, blood is
present. Rinse instruments thoroughly after using
hydrogen peroxide solution.
• Ifsoilisstillpresent,recleantheinstrument.
MAINTENANCE
Between uses, lubricate moving parts with a water-soluble
lubricant in accordance with the manufacturer’s instructions.
INSPECTION AND FUNCTIONAL TESTING
• Visuallyinspecttheinstrumentandcheckfordamage
and wear.
• Cuttingedgesshouldbefreeofnicksandhavea
continuous edge.
• Jawsandteethshouldalignproperly.
• Moveablepartsshouldhavesmoothmovementwithout
excessive play.
• Lockingmechanismsshouldfastensecurelyandclose
easily.
• Long,thininstrumentsshouldbefreeofbending
and distortion.
PACKAGING
• Forinstrumentsthatareprovidedinsets,instrument
trays may be used for containment during sterilization.
• Packagetrays/instrumentswithabarrierwrapmaterial
in accordance with local procedures, using standardized
wrapping techniques such as those described in ANSI/
AAMI ST46-1993.
STERILIZATION
• Useavalidated,properlymaintainedandcalibrated
steam sterilizer.

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• Effectivesteamsterilizationcanbeachievedusingthe
following cycles:
Minimum
Cycle Type Temperature Exposure Time
Prevacuum 132–134°C 4 minutes
Prevacuum 134–137°C 3 minutes
STORAGE
Store sterile packaged instruments in a manner that provides
protection from dust, moisture, insects, vermin, and extremes
of temperature and humidity.
ESPAÑOL
SISTEMA PARA LA PREPARACIÓN
DE INJERTOS DePuy MITEK
NO ESTÉRIL – REUTILIZABLE
DESCRIPCIÓN
Mesa de preparación de injertos:
Mantiene las pinzas, pernos y/o accesorios en su lugar
durante la evaluación, medición, tensado, preparación
y montaje del injerto.
Unidad deslizante:
Se utiliza con la mesa de preparación de injertos como un
accesorio móvil para sostener la pinza tensora, la pinza de
injerto y/o la pinza de sutura.
Pinza tensora:
Se utiliza con la pinza de injerto y/o la pinza de sutura para
sostener tejido blando o la sutura durante el tensado del
injerto. Puede insertarse en la unidad deslizante o en la
mesa de preparación de injertos. La pinza tensora consta de
un cuerpo tensor y una pinza y puede desmontarse.
Pinza para injerto:
Se utiliza con la pinza tensora y/o la pinza de sutura para
sostener el tejido blando o la sutura durante la preparación,
montaje y tensado del injerto. Puede insertarse en la unidad
deslizante o en la mesa de preparación de injertos.

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Pinza para sutura:
Se utiliza con la pinza tensora y/o la pinza para injerto para
sostener la sutura durante la preparación, montaje y tensado
del injerto. Puede insertarse en la unidad deslizante o en la
mesa de preparación de injertos. Puede utilizarse cuando se
sostiene el injerto y se tira de él con la sutura.
Medidor de injertos:
Se utiliza para medir el tamaño de un injerto durante su
preparación y montaje.También se utiliza con la guía de broca
para perforar orificios de sutura en los extremos del injerto.
Guía de broca:
Se utiliza con el medidor de injertos para perforar orificios de
sutura en los extremos del injerto.
Mesa de corte:
Se utiliza con la mesa de preparación de injertos como
superficie de trabajo para la medición, montaje y preparación
de los injertos.
MATERIALES
Mesa de preparación de injertos:
aluminio anodizado con recubrimiento duro y
acero inoxidable
Unidad deslizante, guía de broca:
acero inoxidable
Pinza para sutura:
acero inoxidable
Pinza tensora:
acero inoxidable y PEEK (polieteretercetona)
Pinza para injerto:
acero inoxidable y PEEK (polieteretercetona)
Medidor de injertos y tabla de corte:
PEI (polieterimida) o polifenilsulfona
INDICACIONES
El sistema para la preparación de injertos DePuy Mitek está
diseñado para preparar injertos de tejido blando o de hueso-
tendón para la cirugía reconstructiva del ligamento cruzado
anterior o posterior.
CONTRAINDICACIONES
Cualquier uso que no esté incluido en las indicaciones anteriores.