Veress cannula

Validated reprocessing procedure Aesculap® Veress cannula

General safety information

Legend

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.

1 2 3 4 5 6 7 8

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

Outer shaft Compression spring Inner shaft Spring cap LL-connector Lever Plug, maintenance free (must not be oiled) Marking on cock plug and outer shaft

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used.

Symbols on product and packages

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com

Caution, general warning symbol Caution, see documentation supplied with the product

General notes

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

at https://extranet.bbraun.com

Intended use The Veress cannula is used to puncture the abdominal wall at the start of a laparoscopic operation and to insufflate CO2 gas into the abdominal cavity.

Available sizes Art. no.

Designation

PG003

Veress insufflation needle

Length

Diameter

100 mm

2mm

PG008

120 mm

PG011

150 mm

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. ► Carry out sterile processing of the product prior to every use. ► 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.

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should be left between use and sterile processing, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non 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 damage to the products in case of non stainless steel. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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 reprocessing 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 in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be 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 surface and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, section 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.

Preparation at the place of use ► If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),

using a disposable syringe, for example. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling. ► Open taps (if present).

Cleaning/disinfection

Safe operation

Product-specific safety notes on the reprocessing procedure Risk of injury due to incorrect handling! The Veress cannula can damage organs and tissue. ► Perform the incision with the Veress cannula with care.

WARNING

CAUTION

CAUTION Risk of injury due to loss of gas! ► Remove the instrument only after the procedure is complete. ► Prior to puncturing the abdominal wall, make certain that the lever of the Veress cannula is closed.

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 use, for example, on aluminum, plastic materials, and high-grade steel, – 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 96 °C.

► Use the LL-connector 5 to connect the instrument with the gas line of the insufflator. ► Puncture the abdominal wall at the navel with the Veress cannula.

► 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-

When puncturing the abdominal wall, the inner shaft 3 slides backward into the outer shaft 1 and the sharp tip of the outer shaft 1 is exposed. When the Veress cannula has penetrated the abdominal cavity, the inner shaft 3 springs forward again via the compression spring 2 and covers the sharp tip of the outer shaft 1. ► Open lever 6.

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.

Disassembling ► Unscrew outer shaft 1 and remove from inner shaft 3, see Fig. A. ► Unscrew spring cap 4 and remove plug 7, see Fig. B.

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

Assembling Note Cock plug 7 and outer shaft 1 are each identified by a marking 8, see Fig. D. The marking indicates that only the matched cock plug may be used. ► Apply outer shaft 1 onto inner shaft 3 and screw tight, see Fig. A. ► Insert the plug 7 into the stop cock so that the pin on the plug 7 sits in the recess in the stop cock, see Fig. C. ► Screw together the plug 7 and spring cap 4.

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