Cortical bone mill GB040

5.3

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Aesculap® Cortical bone mill GB040 Legend 1 2 3 4 5

Motor unit with HARRIS coupling Hand crank GB041R Cortical bone mill GB040 Cutting drum Knurled nut

Symbols on product and packages

Safe operation

WARNING ► Attach the cortical bone mill GB040 to the appropriate table ► Mount the motor unit and necessary components, see Attaching the motor drive ► Fill the mill shaft with the bone for grinding and use the pestle to gently grind the substance while the mill is

running.

Disassembly ► Remove the motor unit from the cortical bone mill 8. ► Place your thumb in the front round outlet opening. ► Hold the cutting drum 4 in place and turn the knurled nut 5 to the right until the cutting drum can be taken out

from the front, see Fig. A. Caution, general warning symbol Caution, see documentation supplied with the product

1.

Applicable to

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

2.

Safe handling

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.

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user.

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

3.

6.2

3.1

Product description Components required for operation

The following options are available for driving the cortical bone mill GB040: ■ Hand crank GB041R ■ Motor unit with HARRIS coupling, e.g. GA672 with GB654R

3.2

Intended use

The cortical bone mill GB040 is used for grinding compact bone grafts (both cortical bone and cancellous bone).

4.

Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Check the cortical bone mill and its accessories for visible damage before use. ► Use the cortical bone mill and its accessories only if they are in perfect condition.

5.

Working with the cortical bone mill GB040 Risk of injury due to accidental activation of drive unit! ► Change the cortical bone mill only with the motor unit uncoupled.

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/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 temperatures >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. Failure 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 application/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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

6.3

Dismantling prior to carrying out the reprocessing procedure

► Remove the cutting drum prior to cleaning, see Disassembly.

DANGER

6.4 Damage to the product due to incorrect handling or operation! ► The product must only be coupled while the motor is inactive. CAUTION

Preparations at the place of use

► 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.

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

5.1

System set-up 6.6

Cleaning/disinfection

Connecting the 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.

Product-specific safety instructions for the reprocessing procedure Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually.

Attaching the motor drive Risk of damage to the cortical bone mill or its components due to unauthorized configuration! ► Combine the components only as described in these instructions for use.

CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

CAUTION ► Select the type of drive for the cortical bone mill taking into account the authorized combinations, see Compo-

CAUTION

nents required for operation. ► 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

Function checks

► Make certain that the motor unit is securely seated. ► Briefly run the cortical bone mill GB040 at maximum speed. Check for proper and reliable functioning.

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 instructions which – are approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.