Evolution ES3 Serie Instrucciones De Uso página 5

lids of the kit must be properly assembled prior to sterilization. It is not recommended to
stack assembled kits during sterilization.
Do not place kit on side or upside down. The use of nonabsorbent tray liners can cause
condensation to pool.
Method – Pre-Vacuum Steam Sterilization – for 2nd Generation
Evolution Systems (Part Numbers ES3XXXX and ES4XXXX ONLY.
For example ES30001 or ES40001)
Set parameters at 4 minutes exposure at a temperature of 132˚C (270˚F) with a
minimum of four (4) vacuum pulses prior to actual exposure. A dry time of 30 minutes is
recommended.
Method – Gravity Displacement Steam Sterilization – for 2nd
Generation Evolution Systems (Part Numbers ES3XXXX or ES4XXXX
ONLY. For example ES30001 or ES40001)
Expose instruments for 15 minutes at a temperature of 132° C (270° F). A dry time of 30
minutes is recommended.
Method – Pre-Vacuum Steam Sterilization-for 1st Generation Evolution
Systems (Any other Part Number not listed above.)
Set parameters at 10 minutes exposure at a temperature of 132˚C (270˚F) with a
minimum of four (4) vacuum pulses prior to actual exposure.
Method – Gravity Displacement Steam Sterilization- for 1st Generation
Evolution Systems (Any other Part Number not listed above)
Expose instruments for 30 minutes at a temperature of 132° C (270° F).
Handle sterilized kit following normal operating room procedures.
Allow case to cool thoroughly for a minimum of 15 minutes after sterilization cycle is
complete.
Maintenance
Lubricate hinges, threads and other moving parts with a commercial water-based
surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear.
Follow lubricant manufacturer's instructions.
Storage
Store sterile, packaged instruments in a designated, limited access area that is
well ventilated and provides protection from dust, moisture, insects, vermin, and
temperature/humidity extremes. Examine sterile instrument packages closely prior to
opening to ensure that there has been no loss of package integrity.
Instructions for use
Cautions: The user of this instrument set acknowledges that implant manufacturers
are constantly improving their designs, which could lead to a fit concern with custom
drivers.
Do not use the driver(s) if the instrument does not properly fit into the implanted spinal
hardware.
Prior to inserting the driver into the implant, verify that all foreign material is removed
from the driving surface. Failure to do so could result in the damaging of implants and/
or removal instruments.
The user of the instrument set should ensure that the instrumentation has no more than
60 minutes of direct exposure to the patient. The user of this set should ensure that no
– 4 –