Stryker 242-000-012 Guia Del Usuario página 8

While.these.instructions.have.been.validated.by.the.manufacturer.as.being.capable.
of.preparing.the.tray.for.re-use,.it.remains.the.responsibility.of.the.processor.to.
ensure.that.the.reprocessing.(as.actually.performed,.using.equipment,.materials,.
and.personnel.in.the.reprocessing.facility).achieves.the.desired.result..This.normally.
requires.validation.and.routine.monitoring.of.the.process.
Intended Use of Sterilization Trays
Sterilization.trays.are.plastic.and/or.metal.containers.used.to.hold.and.protect.surgical.
devices.during.the.sterilization.process..They.consist.of.an.interlocking.tray.and.lid,.
which.are.both.perforated.to.allow.the.passage.of.sterilizing.agent.from.outside.the.
tray.to.the.devices.placed.inside..
Sterilization.trays.typically.feature.a.silicon.finger.mat.or.group.of.device.holders.that.
secure.devices.during.the.sterilization.process..Some.models.feature.stacking.internal.
trays.to.allow.the.segregation.of.devices.
Warnings
•. These.instructions.are.validated.only.for.sterilization.of.the.tray.and.device(s).
identified.herein..Using.combinations.or.parameters.not.described.in.this.
manual.may.result.in.incomplete.sterilization.
•. These.instructions.do.not.replace.the.cleaning.instructions.provided.with.
individual.devices..Prior.to.sterilization,.clean.all.devices.as.specified.in.their.
respective.user.manuals..
•. Wear.appropriate.protective.equipment.(gloves,.eye.protection,.etc.).when.
reprocessing.any.medical.device.
•. Both.the.device.and.the.tray.must.be.cleaned.prior.to.sterilization,.or.
incomplete.sterilization.will.result..
•. The.sterilization.tray,.its.lid,.and.any.internal.components.have.been.designed.
and.validated.for.use.as.a.single.system..Do.not.separate.components.from.
the.system,.for.use.individually.or.in.combination,.or.incomplete.sterilization.
may.result.
•. Inspect.the.tray.and.its.components.for.visible.damage,.such.as.cracking.or.
chipping,.prior.to.use..Do.not.use.the.tray.if.it.is.damaged.
Cautions
•. Before.lifting.the.tray.assembly,.verify.that.the.latches.connecting.the.lid.to.
the.tray.are.secure.
•. The.tray.is.not.designed.for.use.as.a.shipping.container..To.avoid.damage,.
remove.all.devices.and.pack.them.separately.
EN-4