Aesculap
®
Tubuluar shank instruments
Legend
1
Rotation wheel
2
Handle
3
Button
4
Movable handle
5
Shaft, complete (outer tube, inner tube, working insert)
6
Instrument jaw
7
Working insert
8
Alignment grooves
9
Inner tube
10
Outer tube
11
Spring elements (tactile feedback)
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
Detachable tubular shaft instruments are used for cutting, dissection and grasping, and removal of biopsies, with
different working tips for each intended use.
They are introduced into the body by means of access instruments (e.g. trocar).
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.
►
To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
►
If using in combination with a HF instrument within a trocar, insert the tubular shaft instrument first, where
possible, to prevent compromising the HF insulation. When removing the instruments, remove the HF instrument
first, if possible.
Safe operation
Note
The spring elements give the user some tactile feedback just before the instrument emerges from trocar FF399R into
the operating site. The functionality of this tactile feedback mechanism is only ensured when using the product with
trocar FF399R.
Disassembling
The tubular shaft instruments are disassembled into the following components:
■
Handle
2
■
Outer tube
10
■
Inner tube
9
■
Working insert
7
►
Detach handle
2
from working insert
7
, see Fig. 1.
– Fully open moveable handle part
4
.
– Push and hold down button
3
.
– At the same time, pull down moveable handle part
4
.
►
Detach the shaft
5
from handle
2
, see Fig. 2
– Pull back rotation wheel
1
towards handle
2
to the positive stop.
– Hold rotation wheel
1
at its positive stop and extract shaft
5
.
►
To disassemble shaft
5
, see Fig. 3:
– Remove outer tube
10
and inner tube
9
from working insert
7
.
– Remove inner tube
9
from working insert
7
, see Fig. 4.
Assembling
►
To assemble shaft
5
, see Fig. 5:
– Slide inner tube
9
with alignment grooves
8
in the direction of the working tip
7
until the alignment
grooves
8
engage.
– Slide outer tube
10
over inner tube
9
onto working insert
7
as far as it will go, see Fig. 6.
►
Connect the shaft
5
to handle
2
:
–
Ensure that outer tube
10
is pushed over inner tube
9
with working insert
7
to the positive stop, see Fig. 7.
–
Slide back and hold rotation wheel
1
at its positive stop, see Fig. 8.
–
Hold the shaft
5
at its closed working tip.
–
Slightly turn shaft
5
and handle
2
during insertion until they connect to each other.
–
Allow the rotation wheel
1
to slide forward, see Fig. 9. Ensure that shaft
5
is securely locked in handle
2
and
cannot be removed even by pulling.
►
Connect handle
2
entirely to shaft
5
:
–
Fully open handle
2
.
–
Slide the movable part of the handle
4
upwards whilst simultaneously holding the working insert
7
until the
button
3
engages, see Fig. 10.
–
Check that moveable handle part
4
is securely locked.
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.
►
Open up products with hinges.
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
►
Do not use oxidizing chemicals (e.g. H
2
O
2
), which could cause bleaching/layer loss of the product.
►
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/
disinfecting.
–
as an integrated mechanical support measure for mechanical cleaning/disinfecting.
–
for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
►
Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
Caution, general warning symbol
Caution, see documentation supplied with the product
WARNING
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
►
Apply the product only under visual control.
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 the material in question (e.g., aluminum, plastics, high-
grade steel).
–
do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
