Directions For Use - Symmetry Surgical VersaPak Instrucciones De Uso

8. To achieve a sterility assurance level of 10
Surgical recommends the following sterilization parameters
(see Table 1 & Table 2):
Table 1: Recommended Steam Sterilization Parameters
Recommended Steam Sterilization Parameters (Double Wrapped)
Cycle Type Minimum
Temperature
Pre-Vacuum 132°C-135°C
270F-275F
Gravity 121°C-123°C
250F-253F
132°C-135°C
270F-275F
Table 2: Recommended EO Sterilization Parameters
Recommended Ethylene Oxide Sterilization Parameters (Double
Wrapped)
Preconditioning
Temperature
Humidity
Pre-Vacuum
Humidity Dwell
Sterilant
Gas Concentration
Gas Dwell
Post Vacuum Cycle
Aeration
Failure to follow the manufacturer's instructions may result in
irreparable damage to the device or in the device contents not
being sterilized.
Reprocessing procedures recommended above have been validated.
Do not use reprocessing procedures outside of what is
recommended in this IFU.
WARNING
Take proper precautions when removing the device from
the sterilization chamber. When steam sterilized, the tray may be
hot. Use proper precautions to prevent injury.
Secure lid to base of VersaPak™ and carry the device by the
handles on the lid. If the device does not have a lid, carry the device
by the handles on the base.
Modifications to the VersaPak
recommended in this IFU may result in loss of guarantee/warranty
rights and forfeiture of applicable licenses.
DISPOSAL/SERVICE
Adhere to national regulations when
disposing of or recycling the product, its components and its
packaging. For service outside the United States, contact your local
Symmetry Surgical representative. Inside the United States, call
Symmetry Surgical Customer Service: 1-800-251-3000.
IFU-LCN-SM0063/Rev D
, Symmetry
-6
Minimum Minimum
Exposure Time Dry Time
4 minutes 20 minutes
55 minutes 20 minutes
30 minutes 20 minutes
None
125F -135F / 52°C-57°C
30-80% RH
22-26" HG
30-45 minutes
10% EO/ 90% HCFC
600 + 30 mg/L
2 hours minimum
22-26" HG (2 cycles)
24 hours @ 110-130F minimum
made outside of what is
™
WARRANTY
Symmetry Surgical warrants that this medical device is free from
defects in both materials and workmanship for one (1) year from the
date of purchase. Any other express or implied warranties,
including warranties of merchantability or fitness, are hereby
disclaimed. Suitability for use of this medical device for any
particular surgical procedure should be determined by the user
in conformance with the manufacturer's instructions for use.
There are no warranties that extend beyond the description on
the face hereof. Abuse or misuse of the product or failure to
comply with the instructions for use shall void this warranty.

DIRECTIONS FOR USE

The VersaPak base is available in the following sizes with the
™
corresponding recommended maximum instrument load (Table 3):
Table 3: Recommended Maximum Instrument Load
Part
Size
Number
50-8530 ½ DIN 100mm
50-8532 Full DIN 100mm
50-8533 Full DIN 100mm
50-8534 Full DIN 100mm
50-8535 Full DIN 100mm
50-8536 ¾ DIN 50mm
50-8537 ½ DIN 50mm
50-8538 ½ DIN 75mm
50-8539 ¾ DIN 50mm
50-8540 ¾ DIN 75mm
50-8541 ¾ DIN 100mm
50-8543 Full DIN 50mm
50-8544 Full DIN 75mm
50-8545 Full DIN 100mm
50-8615 Full DIN 100mm
50-8616 Extended 50mm
50-8617 Extended 50mm
Customizable
The versatility of this device provides options for the customer to
configure their own unique VersaPak

Do NOT load more than the recommended amount of
bracketry into a single VersaPak
Do NOT cover more than 50% of the VersaPak
o
floor holes with bracketry.

VersaPak bases are only compatible with VersaPak
™
bracketry.

Brackets can only be assembled in VersaPak
lids.

Bracket placement must ensure instruments provide
uniform weight across the device for allowable air flow.

For complete portfolio of VersaPak
accessories, contact Symmetry Surgical Customer
Service: Phone: 1-800-251-3000 or E-mail:
[email protected]
Maximum Load (lbs)
13
22
22
22
22
8
8
8
8
13
22
8
22
22
22
22
22
.
™
.
™
bases, not
™
brackets and
™
™
™
3