Tubuluar shank instruments

7.

en ®

Aesculap Tubuluar shank instruments Legend 1 Rotation wheel 2 Handle 3 Button 4 Movable handle 5 Shaft, complete (outer tube, inner tube, working insert) 6 Instrument jaw 7 Working insert 8 Alignment grooves 9 Inner tube 10 Outer tube 11 Spring elements (tactile feedback)

Symbols on product and packages

Disassembling

The tubular shaft instruments are disassembled into the following components: ■ Handle 2 ■ Outer tube 10 ■ Inner tube 9 ■ Working insert 7 ► Detach handle 2 from working insert 7, see Fig. 1. – Fully open moveable handle part 4. – Push and hold down button 3. – At the same time, pull down moveable handle part 4. ► Detach the shaft 5 from handle 2, see Fig. 2

– Pull back rotation wheel 1 towards handle 2 to the positive stop. – Hold rotation wheel 1 at its positive stop and extract shaft 5. ► To disassemble shaft 5, see Fig. 3:

– Remove outer tube 10 and inner tube 9 from working insert 7. – Remove inner tube 9 from working insert 7, see Fig. 4.

8.

Assembling

► Assembling the shaft 5, see Fig. 5:

– Slide inner tube 9 with flexible tongues 8 in the direction of the working tip 7 until the flexible tongues 8 engage. – Slide outer tube 10 over inner tube 9 onto working insert 7 as far as it will go. When doing so, ensure that the arrows of the circumferential marking point towards the handle, see Fig. 6.

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

► Connect the shaft 5 to handle 2:

1.

– – – – –

Intended use

Detachable tubular shaft instruments are used for cutting, dissection and grasping, and removal of biopsies, with different working tips for each intended use. They are introduced into the body by means of access instruments (e.g. trocar).

2.

Indications

Indications, see Intended use. Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

3.

Contraindications

3.1

Absolute contraindications

Ensure that outer tube 10 is pushed over inner tube 9 with working insert 7 to the positive stop, see Fig. 7. Slide back and hold rotation wheel 1 at its positive stop, see Fig. 8. Hold the shaft 5 at its closed working tip. Slightly turn shaft 5 and handle 2 during insertion until they connect to each other. Allow the rotation wheel 1 to slide forward, see Fig. 9. Ensure that shaft 5 is securely locked in handle 2 and cannot be removed even by pulling.

► Connect handle 2 entirely to shaft 5:

– Fully open handle 2. – Slide the movable part of the handle 4 upwards whilst simultaneously holding the working insert 7 until the button 3 engages, see Fig. 10. – Check that moveable handle part 4 is securely locked. ► Check product for proper function: – Completely open and close the tool. – Check rotatability by twisting the star wheel 1.

None known.

9.

Validated reprocessing procedure

3.2

9.1

General safety notes

Relative contraindications

Based on our current knowledge, there are no product-specific relative contraindications. However, there are medical or surgical conditions that may interfere with endoscopic technique, such as strong bleeding that limits the view in the surgical field. In case of relative contraindications, the user shall decide on the use of the product on an individual basis.

4.

Risks and side effects

As part of the legal obligation to provide information, the possible risks and side effects in connection with the use of surgical instruments known to the manufacturer are highlighted below. These are predominantly process-specific, not product-specific, and include unwanted damage to surrounding tissue, such as bleeding, infection, incompatibility of materials, or parts of instruments left unnoticed in the patient.

5.

Safe handling and preparation

► 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. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar). ► If using in combination with a HF instrument within a trocar, insert the tubular shaft instrument first, where possible, to prevent compromising the HF insulation. When removing the instruments, remove the HF instrument first, if possible.

6.

Safe operation

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury and/or malfunction! ► Use instruments FF385R-FF389R only with trocar FF399R.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. The specified chemistry was used for validation.

9.2

General information

Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion. Therefore, do not exceed a period of 1 h between use and processing, make sure pre-cleaning temperatures are <45°C to prevent clotting, and do not use disinfectants that can cause clotting (active ingredient: aldehyde, alcohol). 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. 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 damage to metallic products. 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 processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ 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".

9.3

Reusable products

There are no known effects of processing resulting in damage to the product. The product can be re-used up to 75 times with proper care and if it is undamaged and clean. The user shall be responsible for any further reuse. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

9.4

Note The spring elements give the user some tactile feedback just before the instrument emerges from trocar FF399R into the operating site. The functionality of this tactile feedback mechanism is only ensured when using the product with trocar FF399R.

9.5

Disassembling the product before carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the respective instructions for use. ► Open up products with hinges.

Preparations 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 wet product in a sealed waste container and take it to be cleaned and disinfected within 1 h.

9.6

Preparation before cleaning

► Dismantle the product prior to cleaning, see Disassembling.

9.7

Cleaning/disinfection

9.10 Packaging

9.7.1

Product-specific safety notes on the reprocessing procedure

► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

DANGER Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

9.11 Steam sterilization DANGER Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. 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 the material in question (e.g., aluminum, plastics, high-grade steel). – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► 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. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.

9.8

Mechanical cleaning/disinfection with manual pre-cleaning

Note It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (e.g. fulfillment of EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

9.8.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT (cold)

>15

1

D–W

B. Braun Stabimed® fresh

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: RT:

Note The product can be sterilized either in disassembled or in assembled condition. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

opening any valves and faucets). ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

9.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

10.

Technical Service

WARNING Risk of injury and/or malfunction! ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

11.

Accessories/Spare parts

11.1 For MINOP InVent tubular shaft instruments FH635R, FH636R, FH637R, FH638R, FH639R

Drinking water Room temperature

Phase I ► Clean the product in the solution using a suitable cleaning brush until no residue is visible on the surface. ► If applicable, use a suitable cleaning brush to brush any surfaces that are not visible for at least 1 min. ► Mobilize non-rigid components, such as set screws and hinges, during cleaning. ► Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml).

Art. no.

Designation

FH633R

MINOP InVent hand grip for tubuluar shaft instruments

FH635200

MINOP InVent tubuluar shaft instruments outer tube

FF435R

Jaw part with MINOP mirco-scissors Sh/Sh

Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing.

FF436R

Jaw part with MINOP mirco-scissors Bl/Bl

FF437R

Jaw part with MINOP micro cupped biopsy forceps

9.8.2

FF438R

Jaw part with MINOP micro grasping and preparation forceps

FF439R

Jaw part with MINOP toothed micro forceps

Mechanical alkaline cleaning and thermal disinfection

Type of device: Single-chamber cleaning/disinfection device without ultrasound1) Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

11.2 For MINOP tubular shaft instruments FF385R, FF386R, FF387R, FF388R, FF389R

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 % Working solution2)

Art. no.

Designation

III

Neutralization

>10/50

2

DI–W

B. Braun Helimatic® Neutralizer C 0.15 % working solution

FF432R

Handle only for instruments FF385R–FF389R

FF433R

Outer tube only for FF385R–FF389R

IV

Intermediate rinse I

>10/50

1

DI–W

-

FF435R

Jaw part with MINOP mirco-scissors Sh/Sh

V

Intermediate rinse II

>10/50

1

FD–W

-

FF436R

Jaw part with MINOP mirco-scissors Bl/Bl

VI

Thermal disinfection

90/194

5

FD–W

-

FF437R

Jaw part with MINOP micro cupped biopsy forceps

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

FF438R

Jaw part with MINOP micro grasping and preparation forceps

FF439R

Jaw part with MINOP toothed micro forceps

D–W: Drinking water DI–W: Deionized water 1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele 7836 CD 2) Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Place instruments in the tray with their hinges open. ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

9.9

Inspection, maintenance and checks

CAUTION Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Assemble dismountable products, see Assembling. ► Check product for proper function:

– Completely open and close the tool. – Check rotatability by twisting the star wheel 1. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service.

12.

Disposal

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

TA012978

2020-07

V6

Change No. 60792