■ Notes:
•
The clinical processing instructions provided have
been validated by Synthes for preparing a non-sterile
Synthes medical device; these instructions are
provided in accordance with ISO 17664 and ANSI/
AAMI ST81.
•
Cleaning Agent Information: Examples of detergents
that were used by Synthes during the cleaning
validations include ProlysticaTM 2X Concentrate
Enzymatic Cleaner, ProlysticaTM 2X Neutral
Detergent, Neodisher
®
MediZym.
These cleaning agents are not listed in preference to
other available neutral pH enzymatic or mild al kaline
cleaning agents which may per form equally
satisfactorily.
•
Non-single use brushes and other cleaning tools should
be decontaminated at least once a day using a solution
as detailed in step “3, Spray and Wipe” on page 31.
•
The temperature of the cleaning agent should be
≤ 40°C (104°F) for manual cleaning.
•
Residual organic matter and/or a large number of
microorganisms may reduce the effectiveness of the
sterilization process.
•
Soiled devices should be transported separately from
non-contaminated devices to avoid contamination
when being moved from the operation room to the
reprocessing department.
•
It remains the responsibility of the processor to ensure
that the processing performed achieves the desired
result using the appropriate, properly installed,
maintained and validated equipment, materials and
personnel in the processing unit. Any deviation by the
processor from the instructions provided should be
properly evaluated for effectiveness and potential
adverse consequences.
•
Both UNIUM Handpieces have an IPX6/IPX8/IPX9
rating against water ingress in accordance with IEC
60528:
– IPX6: protected against powerful water jets
– IPX8: protected against the effects of continuous
immersion in water (handpiece immersed 1 meter
deep in water for 35 minutes)
– IPX9: protected against high pressure and
temperature water jets
All three tests were performed with the handpiece
casing cover and front lid fully closed.
•
The UNIUM Power Unit has an IPX4 rating against
water ingress in accordance with IEC 60528:
– IPX4: protected against splashing water.
Please note that for both the UNIUM Handpieces and
the Power Unit only the clinical processing instructions
Care and Maintenance
General Information
provided in this Instructions for Use (see care and
maintenance section) have been validated by Synthes.
•
For all UNIUM compatible items without a designated
place inside the UNIUM Washing and Sterilization
basket, the reprocessing can be done in accordance
with the steps outlined in this Instructions for Use.
However, it remains the responsibility of the processor
to ensure that the processing performed achieves the
desired result.
•
Consult the Synthes brochure titled “Im portant
Information (with Cleaning and Sterilization
Instructions)” for general information on reprocessing.
28
Instruction for Use • UNIUM
™
