HALAR-coated instruments

en ®

AESCULAP HALAR-coated instruments Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

Disassembling the product before carrying out the reprocessing procedure ► Open up instruments with hinges.

Intended use These Aesculap instruments are used in general surgery. Depending on the design of the working ends, they are used for cutting, preparing, holding and/or monopolar coagulation.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician!

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.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

Note The plastic-coated instruments are electrically insulated and can be operated with monopolar HF current. ► 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

CAUTION

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. Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ► Observe the safety guidelines in the instructions for use of the HF device. WARNING

WARNING

Thermal injuries to patients/users due to insufficient insulation of leads in active accessories! ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage does match or not exceed the accessory voltage rating specified for the product.

The manufacturer has tested the product and verified that its insulation can withstand 50 reprocessing cycles. In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions. ► Prior to each use, inspect the products for: damage or surface changes to the insulation. ► Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see Technical Service. ► Adjust the HF power output (and argon flow rate) to the intervention to be carried out. Take into account clinical

experience or reference values. ► Select the lowest possible HF power output. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab. Refer to our brochures to find a compatible cable. The accessory voltage rating of the product is 2 500 Vp. The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2). To avoid HF burns: ► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated. ► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories. ► Never place the product on or next to the patient. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device. ► Follow the instructions for use of the HF device. ► For connection options, refer to the Aesculap accessories range.

Validated reprocessing procedure

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 plastics and stainless steel, for example, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.

Immersion treatment in a 3 % H2O2 solution for approx. 5 minutes is a particularly effective and gentle method to dissolve encrustations from HF instruments. Subsequently, the debris can be removed by hand, with a medium-hard brush and or in an ultrasonic bath. This is followed by the conventional reprocessing steps. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ When cleaning instruments

Chapter Manual cleaning/disinfection and sub-chapter:

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.

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air Manual pre-cleaning with ultrasound and brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place instruments in the tray with their hinges open.

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

General safety information Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

IV

Final rinse

RT (cold)

1

-

FD-W

-

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.

V

Drying

RT

-

-

-

-

Note If there is no final sterilization, then a virucidal disinfectant must be used.

D–W: FD–W:

Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.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.

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.