Care and Maintenance
Packaging, Sterilization and Storage
Packaging
Put clean, dry products into their proper places in the baskets (68.001.650, 68.001.654 and 68.001.651). Additio nally,
use an appropriate sterilization wrap or reusable rigid container system for sterilization, such as a Sterile Barrier System
according to ISO 11607. Care should be taken in order to protect implants as well as pointed or sharp instruments from
contact with other objects that may damage the surface or the Sterile Barrier System.
■ Notes:
•
If baskets (68.001.650, 68.001.654 or 68.001.651) are used for sterilization in a steril ization wrap, then use the
appropriate lid (68.001.653 or 68.001.652).
•
If baskets (68.001.650, 68.001.654 or 68.001.651) are used for sterilization in a rigid container, then a lid (68.001.653
or 68.001.652) is not required.
Sterilization
Steam (moist heat) sterilization shall be performed in a locally approved, cleared pre-vacuum (forced air removal) cycle.
The steam steriliz er should be validated to the requirements of any local standards and guidance such as EN 285 or
AAMI/ANSI ST8, including compliance to the requirements of ISO 17665. The steam sterilizer should be installed and
maintained in compliance to manufac turer’s instructions and local requirements. Ensure that a steam sterilizer cycle is
chosen that is designed to remove air from porous or lumened device loads in accordance to manufacturer’s instruc-
tions and does not exceed the maximal sterilizer load.
Cycle Type
Prevacum
Sterilization
Exposure Time (minutes)
Sterilization Exposure
Temperature
Dry Time (minutes)
Saturated steam-forced air
removal (pre-vacuum)
4
132 °C/270 °F
30–60
3
134 °C/274 °F
30–60
Dry times may be highly variable due to differences in packaging materials (Sterile Barrier System, e.g., wraps or re usable
rigid container), environmental conditions, steam quality, device materials, total mass, sterilizer performance and varying
cool down time. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying.
▲ WARNINGS:
•
Hot air, ethylene oxide, plasma and formaldehyde sterilization are not allowed. Using these methods could destroy
the device with possible secondary damage.
•
Never steam sterilize the handpiece with the casing cover and front lid closed. Follow the basket loading plan to
ensure correct positioning of the device in order to avoid damage to it and prevent infection.
▲ Precautions:
•
UNIUM Devices must be resterilized using either ISO 17665 methods or national standards.
DePuy Synthes recommendations for packed devices are as shown in the table above.
•
Remove the Power Unit from the handpiece to avoid damage.
•
The sterilization parameters are only valid for devices that are adequately cleaned.
•
The following maximum values must not be exceeded: 138 °C/280 °F over a maximum of 18 minutes. Higher values
can damage the sterilized products.
•
Inspect the packages prior to storage for visual moisture or dampness and if found on or within the pack, the
product should be repackaged and sterilized with an increased drying time.
•
Do not accelerate the cooling process as it will damage the Power Tool and could result in harm to the user and
patient.
•
Do not sterilize the Universal Battery Charger II and UNIUM Adapter for UBC II.
Storage
Packaged and sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests
and extremes of temperature and humidity.
Use products in the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on
the label. Storage conditions for products labeled "STERILE" are printed on the packaging label.
41
UNIUM
™
• Instruction for Use
