Aesculap
®
Metha® extraction instrument for cone 12/14 (ND656R)
Legend
1
Tension sleeve
2
Sheath
3
Threaded hole
4
Ledge
5
Top of tension sleeve
6
Chuck
Symbols on product and packages
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The Metha® extractor instrument for cone 12/14 (ND656R) is used for separating Metha® trial neck components of
Metha® osteoprofilers and for explanting non-modular Metha® prostheses (in combination with ND655R).
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, 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
Separating Metha® trial neck components from Metha® osteoprofilers
►
Slide the Metha® extractor instrument for cone 12/14 (ND656R) with chuck
6
over Metha® trial neck component.
►
Tighten tension sleeve
1
in the direction of the arrow towards “close”.
►
Pull off the Metha® trial neck component.
Explanting non-modular Metha® prostheses (in combination with ND655R)
►
Slide the combined Metha® extractor instrument for cone 12/14 (ND656R/ND655R) with chuck
6
over the pros-
thesis cone.
►
Tighten tension sleeve
1
in the direction of the arrow towards “close”.
►
Explant non-modular Metha® prostheses using a slotted hammer (NF275R).
Disassembling
Separating Metha® trial neck components from Metha® osteoprofilers
►
Turn tension sleeve
1
in the direction of the arrow towards "open" until top
5
of tension sleeve
1
sits flush with
ledge
4
.
►
If necessary, remove Metha® trial neck component.
►
Turn tension sleeve
1
further to “open” (as indicated by the arrow) and remove it.
Explanting non-modular Metha® prostheses (in combination with ND655R)
►
Unscrew Metha® impactor/extractor instrument ND655R from threaded hole
3
of ND656R.
►
Turn tension sleeve
1
in the direction of the arrow towards "open" until top
5
of tension sleeve
1
sits flush with
ledge
4
.
►
If necessary, remove the Metha® prostheses.
►
Turn tension sleeve
1
further to “open” (as indicated by the arrow) and remove it.
Assembling
Separating Metha® trial neck components from Metha® osteoprofilers
►
Screw tension sleeve
1
in the direction of the arrow towards "close" onto sheath
2
until top
5
of tension sleeve
1
sits flush with ledge
4
.
Explanting non-modular Metha® prostheses (in combination with ND655R)
►
Screw tension sleeve
1
in the direction of the arrow towards "close" onto sheath
2
until top
5
of tension sleeve
1
sits flush with ledge
4
.
►
Screw Metha® impactor/extractor instrument ND655R into threaded hole
3
of ND656R and tighten it.
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.
►
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
Validated cleaning and disinfection procedure
Caution, general warning symbol
Caution, see documentation supplied with the product
WARNING
Damage to the Metha® prosthesis/prosthesis cone during explantation!
►
Do not reuse explanted Metha® prostheses.
CAUTION
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
–
are approved for high-grade steel,
►
Observe specifications regarding concentration, temperature and exposure
time.
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion
disinfection
■
Cleaning brush: e.g. toothbrush
or tube brush
■
20 ml disposable syringe
■
Drying phase: Use a lint-free
cloth or medical compressed air
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Mechanical alkaline cleaning and
thermal disinfection
■
Place the product in a tray that
is suitable for cleaning (avoid-
ing rinsing blind spots).
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
