Validated Reprocessing Procedure; General Information - B. Braun Aesculap Gebrauchsanweisung

Damage to the product due to incorrect handling or operation!
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Couple the product only while the motor is inactive.
CAUTION
5.1.1 Connecting the accessories
Note
Follow the instructions for use of individual accessories!
Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they
are specifically intended for the respective application, and if they do not compromise the performance and safety
characteristics of the products.
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Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect;
for a contact address, see Technical Service.
5.2 Connecting the spray nozzle (optional)
Spray nozzle damage due to jammed adapter rings!
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Check that the adapter rings at the tip are moving smoothly.
CAUTION
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Pull off cover sleeve 6 towards the front end of the micro-Line straight handpiece/angled handpiece.
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Slightly twist and push on spray nozzle 4 in the direction of arrow 5.
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Check that adapter rings 14 at the tip are moving smoothly.
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Secure the irrigation tube to the tube connector.
This completes the installation of spray nozzle 4.
5.3 Removing the spray nozzle (optional)
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Remove the irrigation tube from the tube olive.
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Remove tool 1.
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Slightly twist and remove spray nozzle 4 against the direction of arrow 5.
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Slide on cover sleeve 6 in the direction of the arrow.
This completes the removal of spray nozzle 4.
5.4 Coupling a tool
Note
When coupling the tools 1, please note that the tools are tightened without using a wrench.
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Rotate the tension ring 8 in the direction of the arrow 7 until it engages.
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Insert tool 1 down to the positive stop.
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Turn tension ring 8 against the direction of arrow 7 until mark 9 on the tension ring and mark 10 on the handle
part are aligned with each other.
The tension ring is closed.
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To check that tool 1 is mounted correctly: Pull at tool 1 (with the drive inactive).
Tool 1 is coupled firmly, without slack in the tool adapter.
5.5 Uncoupling the tool
Damage to the micro-Line straight handpiece/angled handpiece caused by jammed
drive unit/motor!
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Make certain the tool was inserted correctly.
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Ensure that the tension ring of the micro-Line straight handpiece/angled
CAUTION
handpiece is closed.
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Rotate the tension ring 8 in the direction of the arrow 7 until it engages.
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Remove tool 1.
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Turn tension ring 8 against the direction of arrow 7 until mark 9 on the tension ring and mark 10 on the handle
part are aligned with each other.
This completes the uncoupling of tool 1.
5.6 Coupling the drive unit/motor
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Push centering lug 2 into the coupling of the micro-Line straight handpiece/angled handpiece so that the drive
unit/motor engages audibly.
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Pull at the drive unit/motor to check that it is coupled correctly.
This completes the coupling of the drive unit/motor.
5.7 Uncoupling the drive unit/motor
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Unlock release mechanism 3 by pressing at the drive unit/motor.
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Remove the drive unit/motor.
This completes the uncoupling of the drive unit/motor.
5.8 Function checks
Damage to the product due to incorrect handling or operation!
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Couple the product only while the motor is inactive.
CAUTION
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Check all cutting edges for any mechanical damage.
5.8.1 micro-Line straight handpiece/angled handpiece
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Always carry out a trial run prior to using the product.
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Check that tool 1 is coupled correctly.
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Briefly run tool 1 at maximum speed.
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Make certain the product does not produce atypical running noise or vibration during the trial run.
5.8.2 Irrigation set (optional)
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Switch on the irrigation pump and check the irrigation set for any blockage or leaks.
5.8.3 Tool
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Check all cutting edges for any mechanical damage.
5.9 Safe operation
Risk of burns to patient and user, caused by hot tool!
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Only use sharp tools.
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Use irrigation for cooling the tool and to remove any chipping.
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Observe the correct reaming direction.
WARNING
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Put down the hot tool beyond reach of the patient.
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Use a cloth to protect against burns when changing the tool.
Risk of injury and material damage due to incorrect operation of the micro-Line
straight handpiece/angled handpiece or drive units!
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Always follow the safety advice and information given in the instructions for
use of the handpieces and motors.
WARNING
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Do not exceed the specified maximum motor speed.
Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
WARNING
Risk of injury to the patient due to inadvertent slipping/rattling of the tool!
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Only apply minimal force when working laterally with the micro-Line straight
handpiece.
WARNING
Risk of contamination and infection if surgical gloves are damaged by a sharp
tool!
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Do not touch the cutting edges of the tool, neither when changing tools nor
during use.
WARNING
6.

Validated reprocessing procedure

6.1 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.
6.2

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.
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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.
6.3 Dismantling prior to carrying out the reprocessing procedure
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Disassemble the product immediately after use, as described in the respective instructions for use.
6.4 Preparations at the place of use
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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.
6.5 Preparation before cleaning
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Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
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Prior to the first mechanical cleaning/disinfection process, mount Eccos holder GB681R or GB682R in a suitable
tray (e.g. JF214R).