Warnings And Precautions - Symmetry Surgical VersaPak Instrucciones De Uso

WARNINGS AND PRECAUTIONS

The federal law restricts this device to sale by or on the
order of a physician.
Warnings

The VersaPak tray is provided NON-STERILE. Remove all
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transport packaging and properly clean and sterilize the
device prior to each use.

Read, follow, and keep these instructions for use. Persons
using this product should have the requisite training,
knowledge, and experience. Use product only in accordance
with its intended use.

Prior to each use, inspect the product for loose, bent, broken,
cracked, worn, or fractured components.

Do not use the product if it is damaged or defective. Set aside
the product if it is damaged and get a new VersaPak™ tray.

Replace any damaged components immediately with original
replacement parts.

Failure to remove detergent residue from reprocessing can
affect the anodized aluminum finish.

The VersaPak™ tray and its contents must not exceed 25 lbs
(11.3 kg) or size-specific limiting weight restrictions as
defined in Table 3 for proper sterilization.

VersaPak™ bases are only to be used with approved
VersaPak brackets.
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
Do not cover more than 50% of the VersaPak
with bracketry.

The VersaPak is NOT intended to be used to contain
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endoscopes during sterilization.

Failure to follow the manufacturer's instructions may result in
irreparable damage to the device or in the device contents
not being sterilized.
Precautions

Use care when transporting the loaded, non-sterile tray, as
aggressive handling or dropping of the tray can cause
damage to the unit and instruments contained within.
The product should be inspected prior to use. Check to confirm that
the tray is clean before use and that the product functions correctly.
Do not use if there is damage, evidence of corrosion, or if the tray is
not operating properly.
The device should be inspected for damage prior to each use.
Devices that show signs of damage should not be used. In addition
to structural inspection, the following areas should be carefully
assessed:

Latch on the lid

Handles on the lid and base

Silicone brackets

Screws
IFU-LCN-SM0063/Rev D
REPROCESSING INSTRUCTIONS
Remove all surgical instruments from the VersaPak™ tray prior to
cleaning. Do not remove brackets from the VersaPak
cleaning or sterilization purposes.
Cleaning
Clean the VersaPak
according to the recommended directions in Symmetry Surgical IFU-
204233.
automated washers. Use an instrument cleaning detergent suitable
for use with anodized aluminum. A detergent with excellent rinsing
and controlled sudsing is recommended. Please consult your
cleaning/detergent supplier for more information.
Copies of IFU #204233 are available by requesting from Symmetry
Surgical Customer Service at: Phone: 1-800-251-3000
Email: customerservice@symmetrysurgical.com
Website:
Sterilization
The VersaPak
wrap (double wrapped) or inside an FDA-cleared sterilization
container. The VersaPak
steel, and silicone and are compatible with steam and ethylene oxide
sterilization.
Follow the manufacturer's recommendations for sterilization for each
instrument placed inside of the VersaPak
floor holes
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Make certain that all external and internal surfaces of the product will
be exposed to the sterilizing agent.
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tray before first use and after each use
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The VersaPak tray may be washed manually or in
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www.symmetrysurgical.com
tray can be used in either FDA-cleared sterilization
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tray is made from aluminum, stainless
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When sterilizing several products at the same time in a
steam sterilizer, ensure that the maximum load capacity of
the steam sterilizer specified by the manufacturer is not
exceeded.
Clean and decontaminate instruments and devices per the
manufacturer's instructions
Disassemble instruments and devices as required per the
manufacturer's instructions prior to sterilization.
Complex instruments (e.g. instruments with lumens and
channels) should be prepared and sterilized according to
the instrument manufacturer's instructions.
See Table 3 for recommended instrument weight per
VersaPak . Recommended weights are based upon
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limiting the total loaded container weight to approximately
25 Ibs (11.3 kg) per ANSI/AAMI ST77, Containment
Devices for Reusable Medical Devices.
Instruments should be uniformly distributed across the
VersaPak . Ensure that instruments are properly loaded so
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that they do not contact or interfere with closing the lid or
other instruments in the case. Hinged devices should be in
an open position when placed in the VersaPak
Do not place device upside down in the sterilization
chamber.
Do not use device outside of what is recommended in this
IFU.
tray for
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during reprocessing.
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prior to sterilization.
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