acumed Anatomic Radial Head System Handbuch Seite 21

EN
patient's expectations or may deteriorate with time, necessitating
revision surgery to replace the implant or to carry out alternative
procedures. Revision surgeries with implants are not uncommon.
SURGICAL INSTRUMENT PRECAUTIONS: Single use
surgical instruments shall never be reused. Previous stresses
may have created imperfections, which can lead to a device
failure. Protect instruments against scratching and nicking. Such
stress concentrations can lead to failure.
ADVERSE EFFECTS: Possible adverse effects are pain,
discomfort, or abnormal sensations and nerve or soft tissue
damage due to the presence of an implant or due to surgical
trauma. Fracture of the implant may occur due to excessive
activity, prolonged loading upon the device, incomplete healing,
or excessive force exerted on the implant during insertion. Implant
migration and/or loosening may occur. Metal sensitivity,
histological, allergic or adverse foreign body reaction resulting
from implantation of a foreign material may occur. Nerve or soft
tissue damage, necrosis of bone or bone resorption, necrosis of
the tissue or inadequate healing may result from the presence of
an implant or due to surgical trauma.
CLEANING:
Implant Cleaning: Implants are provided sterile only and
should not be re-cleaned.
Instrument Cleaning: Acumed Instruments and Accessories
must be thoroughly cleaned before reuse, following the guidelines
below:
PKGI-42-T Effective 08-2019
Warnings & Precautions
 Decontamination of reusable instruments or accessories
should occur immediately after completion of the surgical
procedure. Do not allow contaminated instruments to dry prior
to cleaning/ reprocessing. Excess blood or debris should be
wiped off to prevent it from drying onto the surface.
 All users should be qualified personnel with documented
evidence of training and competency. Training should be
inclusive of current applicable guidelines and standards and
hospital policies.
 Do not use metal brushes or scouring pads during manual
cleaning process.
 Use cleaning agents with low foaming surfactants for manual
cleaning in order to see instruments in the cleaning solution.
Cleaning agents must be easily rinsed from instruments to
prevent residue.
 Mineral oil or silicone lubricants should not be used on Acumed
instruments.
 Neutral pH enzymatic and cleaning agents are recommended
for cleaning reusable instruments. It is very important that
alkaline cleaning agents are thoroughly neutralised and rinsed
from instruments.
 Surgical instruments must be dried thoroughly to prevent rust
formation, even if manufactured from high grade stainless steel.
 All instruments must be inspected for cleanliness of surfaces,
joints, and lumens, proper function, and wear and tear prior to
sterilization.
 Anodized aluminum must not come in contact with certain
cleaning or disinfectant solutions. Avoid strong alkaline
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