Modular suction cannulas

General information

Aesculap® Modular suction cannulas Legend 1 2 3 4 5 6 7 8 9

Thumb plate with suction interruption/control Suction tube Designation of lateral drills Labeling of size (French) Labeling of working length (mm) Detent for bead Detent for groove Hexagon on the thumb plate Hexagon on the suction tube

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

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.

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.

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 modular suction cannula system is specially suited for microsurgical interventions in neurosurgery and ENT surgery. It can also be used in many other disciplines such as oral and maxillofacial surgery, spine surgery or cardiothoracic surgery.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

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

CAUTION

Available sizes The modular suction cannula system comprises: ■ Thumb plate with suction interruption/control ■ Suction tubes The suction tubes are available in different diameters, working lengths and working tips. Note Detailed information about the available sizes is given in the Aesculap brochures.

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and high-grade steel, according to the manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °C.

► Do not use oxidizing chemicals (e.g. H2O2), 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:

Safe handling and preparation

– as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfection.

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.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Use appropriate cleaning brushes

Chapter Manual cleaning/disinfection and sub-chapter:

for the length and diameter of the suction tubes.

■ Place the instrument in a tray that is

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

suitable for cleaning (avoiding rinsing blind spots).

Assembling Connecting the suction tube and thumb plate ► Insert suction tube 2 into the thumb plate 1 in the direction of the arrow, see Fig. C. ► Insert suction tube 2 through the hexagon on the suction tube 9 into the hexagon on the thumb plate 8, see Fig. F. When doing so, ensure that the suction tube 2 is positioned at the required angle. ► Lock suction tube 2 against the resistance of detent 6 and 7.

ultrasound and immersion disinfection

or medical compressed air

Disassembling Separating the suction tube and thumb plate ► Withdraw suction tube 2 against the resistance of detent 6 and 7 in the direction of the arrow, see Fig. B.

■ Chapter Manual cleaning with

■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Connect components with lumens

■ Chapter Manual pre-cleaning

and channels directly to the rinsing port of the injector carriage.

■ Chapter Mechanical alkaline

with a brush 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-

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.

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

-

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.

III

Disinfection

RT (cold)

15

2

D–W

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

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

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.