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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.
Single-use products
Infection hazard for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product!
WARNING
Art. no.
Designation
GE700SU
Hi-Line XS activC drill XL-I D1, 5
FW787R
activC Chisels
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.
Disassembling the product before carrying out the reprocessing procedure
►
Disassemble the product immediately after use, as described in the respective instructions for use.
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.
Preparation before cleaning
►
Dismantle the product prior to cleaning, see Disassembling.
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 use, for example, on aluminum, plastic materials, and
high-grade steel,
– do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 60 °C.
►
Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
►
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
Cleaning brush: TA011944
ultrasound and immersion
■
20 ml disposable syringe
disinfection
■
■
When cleaning products with movable
FW789R–FW800R
hinges, ensure that these are in an open posi-
■
FW870
tion and, if applicable, move the joint while
■
cleaning.
FW871R
■
■
FW789R–FW800R: Clean reamer guide 3,
FW784R
chisel guide 10 and handle 2 with locking
pipes 11 in closed position ( ) and do not
move them during cleaning.
■
Drying phase: Use a lint-free cloth or medical
compressed air
■
Manual pre-cleaning with
Cleaning brush: TA011944
brush and subsequent
■
20 ml disposable syringe
mechanical alkaline clean-
■
ing and thermal disinfec-
Mount jaws protection on the product.
tion
■
Place the product in a tray that is suitable for
■
FW789R–FW800R
cleaning (avoiding rinsing blind spots).
■
Connect components with lumens and chan-
nels directly to the rinsing port of the injector
carriage.
■
Keep working ends open for cleaning.
■
Place products in the tray with their hinges
open.
■
Manual pre-cleaning with
Cleaning brush: TA011944
ultrasound and brush, and
■
20 ml disposable syringe
subsequent mechanical
■
alkaline cleaning and ther-
Place the product in a tray that is suitable for
mal disinfection
cleaning (avoiding rinsing blind spots).
■
■
FW870
Connect components with lumens and chan-
■
nels directly to the rinsing port of the injector
FW871R
carriage.
■
FW784R
■
Keep working ends open for cleaning.
■
Place products in the tray with their hinges
open.
■
Clean reamer guide 3, chisel guide 10 and
handle 2 with locking pipes 11 in closed
position ( ) and do not move them during
cleaning.
Manual cleaning/disinfection
►
Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►
After manual cleaning/disinfection, check visible surfaces visually for residues.
►
Repeat the cleaning /disinfection process if necessary.
Manual cleaning with ultrasound and immersion disinfection
Phase
Step
T
[°C/°F]
I
Ultrasonic
RT (cold)
cleaning
II
Intermediate
RT (cold)
rinse
III
Disinfection
RT (cold)
IV
Final rinse
RT (cold)
V
Drying
RT
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT:
Room temperature
*Recommended: BBraun Stabimed
►
Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►
Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►
If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the product in the disinfectant solution.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Reference
Chapter Manual clean-
ing/disinfection and sub-
chapter:
■
Chapter Manual cleaning
with ultrasound and
immersion disinfection
Chapter Mechanical clean-
ing/disinfection with manual
pre-cleaning and sub-chap-
ter:
■
Chapter Manual pre-
cleaning with a brush
■
Chapter Mechanical
alkaline cleaning and
thermal disinfecting
Chapter Mechanical clean-
ing/disinfection with manual
pre-cleaning and sub-chap-
ter:
■
Chapter Manual pre-
cleaning with ultrasound
and brush
■
Chapter Mechanical
alkaline cleaning and
thermal disinfecting
t
Conc.
Water
Chemical
[%]
quality
[min]
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1
-
D–W
-
15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1
-
FD-W
-
-
-
-
-
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