Safe Operation; Validated Reprocessing Procedure - B.Braun Aesculap CRANIOFIX 2 Mode D'emploi

®
Aesculap
CRANIOFIX2 instrument set
Legend
1 CRANIOFIX2 Applier FF494R
2 Lubrication points of the CRANIOFIX2 applier
3 CRANIOFIX2 cutting forceps FF103R
4 CRANIOFIX2 removal forceps FF104R
5 CRANIOFIX2 holding forceps FF105R
6 CRANIOFIX2 titanium clamp FF490T, ∅ 11 mm
7 CRANIOFIX2 titanium clamp FF491T, ∅ 16 mm
8 CRANIOFIX2 titanium clamp FF492T, ∅ 20 mm
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
The CRANIOFIX2 instrument set is used for the implantation of CRANIOFIX2 titanium clamps.
The CRANIOFIX2 instrument set consists of the following components:
■
CRANIOFIX2 applicator
■
CRANIOFIX2 cutting forceps
■
CRANIOFIX2 removal forceps
■
CRANIOFIX2 holding forceps
■
CRANIOFIX2 storage tray
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
►
Read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended use.
►
Remove the transport packaging and clean the new product, (either manually or mechanically, CRANIOFIX2
applicator FF494R only mechanically), prior to its initial sterilization.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
►
Replace any damaged components immediately with original spare parts.

Safe operation

CRANIOFIX2 applicator
Damage to/destruction of the titanium clamps due to use an incompatible appli-
cator!
►
Use CRANIOFIX2 applicator FF494R only for CRANIOFIX2 titanium clamps
FF490T to FF492T.
CAUTION
►
Use CRANIOFIX applicator FF102R, FF106R and FF107R only for CRANIOFIX
titanium clamps FF099T to FF101T.
The applying forceps CRANIOFIX2 1 cannot be taken apart.
The CRANIOFIX2 applying forceps is compatible with the CRANIOFIX2 storage tray FF094P.
The CRANIOFIX2 applicator 1 has a stress relief to ensure the maximum load sustainable by the pin is not exceeded
when a CRANIOFIX2 titanium clamp is applied.
CRANIOFIX2 holding forceps
►
In order to avoid damage to the toothing of the pin, grasp the CRANIOFIX2 titanium clamps with the CRANIOFIX2
holding forceps 5 on the retaining groove.
CRANIOFIX2 cutting forceps
The edges of the CRANIOFIX2 cutting forceps 3 have a rounded shape so that they center themselves in the hollow
of the CRANIOFIX2 titanium clamps. This means that the cut surface does not project, or only slightly projects, over
the upper edge of the CRANIOFIX2 titanium clamp.
The CRANIOFIX2 cutting forceps must be replaced if one of the following indications for too much wear to the cut-
ting edges is in evidence:
■
The cutting forceps requires greater forces on the CRANIOFIX2 titanium clamp during the cutting process.
■
The cut edge on the pin is too large.
►
When cutting, in order to avoid the protruding pin jumping into the operating field: Hold onto the protruding
pin of the CRANIOFIX2 titanium clamp.
CRANIOFIX2 removal forceps
►
Apply the CRANIOFIX2 removal forceps 4 with its teeth in the indentations intended for this purpose (4 notches)
in the CRANIOFIX2 titanium clamp.

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 the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.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.
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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
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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
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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
Risk to patients!
►
Only mechanically clean the CRANIOFIX2 applicator FF494R!
DANGER
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfectant agents in line with the manufacturer's instruc-
tions that are approved for stainless steel.
CAUTION
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum allowable temperature of 55 °C.
►
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/
disinfecting.
– 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
When cleaning products with
disinfection
movable hinges, ensure that
■
these are in an open position
FF103R
■ and, if applicable, move the
FF104R
joint while cleaning.
■
FF105R ■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Mechanical alkaline cleaning and
Place the product in a tray that
thermal disinfection
is suitable for cleaning (avoid-
■
FF103R ing rinsing blind spots).
■
■
Connect components with
FF104R
■ lumens and channels directly to
FF105R
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 ultra-
Cleaning brush: e.g. FF494801
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-
FF494R
ing rinsing blind spots).
■
Keep working ends open for
cleaning.
■
Place products in the tray with
their hinges open.
Reference
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and sub-chapter:
■
Chapter Manual pre-cleaning
with ultrasound and brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing