B.Braun Aesculap DX646T Mode D'emploi page 3

Interactions between MRI and implant components!
■
MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an
additional risk to implant wearers.
■
MRI causes non-critical, localized heat development.
■
Implants produce moderate MRI artifacts.
Tissue damage due to heatup of Aesculap Bone Fixation components during MRT
examinations!
►
Preferably use low field strengths and sequence techniques with low SAR
exposure.
WARNING
►
Prior to the examination, warn the patient of possible heat sensations and spe-
cifically monitor such heat sensations.
►
Abort the examination immediately as soon as heat development occurs.
■
Delayed healing can cause implant breakage due to metal fatigue.
■
Bone screws once removed from the screw magazine must not be placed back into the screw magazine.
■
The implant components applied, along with their article numbers, the name of the implant, as well as the batch
number and serial number (if available) must be documented in all patient records.
■
The surgeon in charge of the therapy shall make any decision with regard to the removal of implant components
that have been used.
■
Replace the screwdriver blade as soon as it shows functional ware (screws not held by the blade anymore).
Sterility
■
The implant components are supplied in unsterile condition.
■
The implant components are in packages of 8 pieces.
►
Store the implant components in their original packaging and only remove them from their original and protec-
tive packaging immediately prior to application.
►
Use the implant system storage devices for processing, sterilization and sterile setup.
►
Ensure that the implant components do not come into contact with each other or with instruments in their
implant system storage devices.
►
Ensure that the implant components are not damaged in any way.
For implant components that are to be resterilized:
Intraoperative contamination with blood, secretions, and other fluids may render
the affected component unsuitable for resterilization!
►
Handle the implants with new gloves only.
►
Keep the implant system storage devices covered or closed.
WARNING
►
Process implant system storage devices separately from instrument trays.
►
Reprocess the implant components individually and separately if no implant
system storage devices are available, ensuring that the implant components
are not damaged in the process.
►
Carry out the final rinse with distilled, demineralized, or fully desalinated
water.
►
Always observe the applicable hospital guidelines concerning the supply of
sterile materials.
Disassembling the screwdriver
►
Pull screw securing sleeve 4 from screwdriver bit 5.
►
Retract sleeve on silver-colored steel end 3 and pull screwdriver bit out of the screwdriver handle 2.
Assembling the screwdriver
►
Retract sleeve on silver-colored steel end 3 and insert six-sided end of screwdriver bit 5 into screwdriver
handle 2.
►
Turn screwdriver bit 5 until it couples in the screwdriver handle 2.
►
Guide screw securing sleeve 4 completely over screwdriver bit 5.
Validated reprocessing procedure
General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product's materials according to the chemical manufacturers' recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■
Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fracturing, premature aging or swelling.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
►
Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Preparations at the place of use
►
If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
►
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which
CAUTION
– are approved for plastics, surgical steel varieties, titanium alloy and pure
titanium,
– do not contain solvents (e.g. acetone or benzine).
►
Do not apply processing procedures involving the use of hydrogen peroxide.
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 60 °C.
Note
The Bone Fixation screws are processed in their screw magazines.
►
Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/dis-
infecting.
– as an integrated mechanical support measure for mechanical cleaning/disinfecting.
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
Validated cleaning and disinfection procedure
Validated procedure Specific requirements
■
Manual cleaning with immersion
Cleaning brush, e.g., TA011204
disinfection
■
20 ml disposable syringe
■
Screwdriver bit DX606R
■
When cleaning products with
■
Screw magazine storage DX620
movable hinges, ensure that
■
Spiral drills DX629R to DX631R these are in an open position
and, if applicable, move the
joint while cleaning.
■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Manual cleaning with ultrasound
Cleaning brush, e.g., TA009800
and immersion disinfection
or TA007747
■
■
Screw holding sleeve DX604R
20 ml disposable syringe
■
■
Screwdriver handle DX605R
When cleaning products with
movable hinges, ensure that
these are in an open position
and, if applicable, move the
joint while cleaning.
■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Mechanical alkaline cleaning and
Place the product on a tray that
thermal disinfection
is suitable for cleaning (avoid
■
Screwdriver bit DX606R rinsing blind spots).
■
Screw magazines DX608T,
DX610T, DX612T, DX614T,
DX646T, DX648T and DX650T
■
Screw magazine storage DX620
■
Spiral drills DX629R to DX631R
■
Manual pre-cleaning with brush
Cleaning brush, e.g., TE654202
and subsequent mechanical alka-
■
20 ml disposable syringe
line cleaning and thermal disinfec-
■
tion Place the product in a tray that
■
is suitable for cleaning (avoid-
Screwdriver handle DX605R
ing rinsing blind spots).
■
Manual pre-cleaning with ultra-
Cleaning brush, e. g. TE654202
sound and brush, and subsequent
■
20 ml disposable syringe
mechanical alkaline cleaning and
■
thermal disinfection
Place the product in a tray that
■
is suitable for cleaning (avoid-
Screw holding sleeve DX604R
ing rinsing blind spots).
Reference
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
ultrasound and immersion dis-
infection
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and sub-chapter:
■
Chapter Manual pre-cleaning
with a brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and subsection:
■
Chapter Manual pre-cleaning
with ultrasound and brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing