MINOP InVent trocar 30°

en

Aesculap® MINOP InVent trocar 30° Legend

3.

Contraindications

1 MINOP InVent trocar 2 Groove 3 Release button 4 Irrigation connector 5 Endoscope 6 Locking pin endoscope 7 Obturator for the oval working channel 8 Obturator for optical channel 9 Locking pin obturator 10 Wing nut 11 Holding arm adapter

3.1

Absolute contraindications

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

1.

Intended use

The MINOP InVent trocar system is used for endoscopic and endoscope-assisted surgery on the central nervous system, particularly for the treatment of intraventricular and paraventricular pathological structures. The MINOP InVent trocar system can be used either freehand or via the holding arm adapter RT068R on the appropriate holding arm, and can be used with the instruments for the MINOP InVent system.

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.

None known.

3.2

Relative contraindications

Based on our current knowledge, there are no productspecific relative contraindications. However, there are medical or surgical conditions that may interfere with endoscopic technique, such as strong bleeding or high protein levels within the ventricular system limiting the view in the surgical field. In the case of relative contraindications, the user decides individually on the use of the product.

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 in the patient unperceived.

5.

Safe handling and preparation

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

Note A specially designed Aesculap endoscope is offered for the MINOP InVent trocar system. For reasons of compatibility, the MINOP InVent trocars may only be used with this special Aesculap endoscope.

2

en ► 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. ► Perform a function check of the irrigation channel before each use. ► Perform a function check of the endoscope's stop mechanism before each use. ► To avoid burns when using the MINOP InVent trocar in combination with HF electrodes, ensure that HF current is activated only under visual control. ► When inserting the trocar into the brain/the ventricle, close the working channel with the obturator provided.

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

WARNING

Risk of injury caused by protruding 30° endoscope in locked position! ► Insert the endoscope only when the trocar is in its final position.

WARNING

Risk of burns due to high temperature of the instrumentside end of the optical cable of a light source! ► Apply proper care when operating the light source.

CAUTION

CAUTION

Damage to the endoscope due to incorrect handling or operation! ► Insert the endoscope into the trocar only if the trocar is not deformed, bent or kinked. Malfunction and/or OP delay! ► Insert balloon catheters or other instruments which change in volume through the oval working channel only.

3

en Note There is an approx. 2 mm marking on the shafts of the MINOP InVent sliding shaft and round shaft instruments. As soon as this marking passes the proximal end of the oval working channel, the instrument emerges from the trocar.

6.1

The MINOP InVent trocar 1 is used with a 30° endoscope 5 (MINOP 30° angled endoscope). ► In order to close the working end of the trocar atraumatically, – insert obturator for optical channel 8 into the optical channel 14 and – insert obturator for the oval working channel 7 into the working channel 12, see Fig. 1. There is constant irrigation via the irrigation channel. The irrigation fluid drains out via the large working channel 12 and the small working channel 13, see Fig. 1.

► Making sure that the locking pin 6 of the endo-

Camera assembly

Note Connect the camera only with the endoscope locked in the working trocar! ► Lock the endoscope 5 in the MINOP InVent

trocar 1, see Fig. 2, scope 5 is on the same side as the release button 3 of the MINOP InVent trocar 1.

5 6

13

12 14

3 1

Fig. 1 ► For hands free operation, attach the MINOP InVent

trocar 1 to the holding arm using the holding arm adapter 11 and the wing nut 10. Note The endoscopes offered for application with the MINOP InVent system must be used with a light source equipped with a spare bulb. Fig. 2

4

en ► Connect light cable and camera, see Fig. 3–5.

5

1

5

1

Fig. 5

6.2 Fig. 3

Camera disassembly

Note Extract the endoscope from the working trocar only after the camera has been demounted from the endoscope. ► Disconnect camera and light cable from the

endoscope 5, see Fig. 6 and see Fig. 7.

5

1

5

1

Fig. 4

Fig. 6

5

en ► Press the release button 3 and remove the endo-

scope 5 from the MINOP InVent trocar 1, see Fig. 8.

5

1

5

3

1

Fig. 7

Fig. 8

6

en 7.

Trocar disassembly

7.1

Removing the obturator for working/drainage channels

Note This step is only necessary if the obturator for the working or drainage channel is being used.

7.2

Removing the obturator for optical channel or endoscope

► Press the release button 3 and carefully remove the

obturator for the optical channel 8 from the MINOP InVent trocar 1, see Fig. 10.

► Remove the obturator for the oval working

channel 7 carefully from the MINOP InVent trocar 1, see Fig. 9.

8

3

7

8 1 1

Fig. 10

Fig. 9

7

en ► Press the release button 3 and remove the endo-

scope 5 from the MINOP InVent trocar 1, see Fig. 11.

7.3

Removing irrigation tube

► Remove tube from irrigation connector 4, see

Fig. 12.

7

3

1

1

Fig. 12 Fig. 11

8

4

en 7.4

Removing the holding arm adapter

► Unscrew the wing nut 10. ► Remove holding arm adapter 11, see Fig. 13.

8.

Trocar assembly

8.1

Inserting the endoscope/obturators

► Carefully insert the endoscope 5/obturator for the

optical channel 8 into the MINOP InVent trocar 1 axially, ► making sure that the locking pin 6 of the endoscope 5 or locking pin 9 of the obturator for the optical channel 8 is on the same side as the release button 3 of the MINOP InVent trocar 1, see Fig. 14 and see Fig. 15.

11

1

10

5 6 3 1

Fig. 13

Fig. 14

9

en 8.2

Inserting the obturator for the oval working channel

► Hold the obturator for the oval working channel 7

at the distal end and carefully insert it into the working channel 12 as far as the stop, see Fig. 16. Due to friction in the channel, the obturator is secured from falling out.

8 9 3

7 1

Fig. 15 ► Insert

the endoscope 5/obturator for optical channel 8 as far as the stop or until the locking pin 6 or 9 clicks into place, so that the endoscope 5/obturator for optical channel 8 can only be removed by activating the release button 3. Fig. 16

10

en 8.3

Assembling the holding arm adapter

► Unscrew the wing nut 10 of the holding arm

adapter 11, see Fig. 17.

► Insert the holding arm adapter 11 laterally into the

hole (either right or left), until the flange engages in the appropriate groove 2 that secures the holding arm in place, see Fig. 18.

10 11 11

2

Fig. 17

Fig. 18

11

en ► Screw on the wing nut 10 until the holding arm

adapter 11 is fixed in place, see Fig. 19. MINOP InVent-Trocar 1 is now ready to be fitted to the holding arm.

8.4

connector 4, see Fig. 20. ► Check the irrigation function.

4

11 10 1

Fig. 20

Fig. 19

12

Connecting the irrigation tube

► Connect the irrigation tube with the irrigation

en 9.

Validated reprocessing procedure

9.1

General safety notes

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 1h 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 surface and could cause corrosion ► For detailed information on hygienically safe and material-friendly/careful processing, please refer to www.a-k-i.org Header "AKI-Brochures", "Red brochure".

9.3

Reusable products

There are no known effects of processing that result 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.

9.4

Disassembling the product before carrying out the reprocessing procedure

► Disassemble the product immediately after use, as

described in the respective instructions for use.

9.5

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 1h.

9.6

Preparation before cleaning

► Disassemble the product prior to cleaning, see Tro-

car disassembly.

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en 9.7

Cleaning/disinfection

Product-specific safety notes on the reprocessing procedure

DANGER

Risk to patients! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

DANGER

Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray.

CAUTION

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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 exceed the maximum permitted cleaning temperature of 55 °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 formation 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.

en 9.8

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must in principle have a tested effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning using 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:

Drinking water Room temperature

Phase I ► Clean the product using a suitable cleaning brush in the solution until there is no residue 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). Phase II ► Rinse/flush the instrument thoroughly (all accessi-

ble surfaces) under running water. ► Mobilize non-rigid components, such as set screws

and hinges, during rinsing.

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en 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

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1% Working solution2)

III

Neutralization

>10/50

2

DI–W

B. Braun Helimatic® Neutralizer C Working solution 0.15%

IV

Intermediate rinse I

>10/50

1

FD–W

-

V

Intermediate rinse II

>10/50

1

DI–W

-

VI

Thermal disinfection

90/194

5

FD–W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

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) ► Open the links and joints before placing the product on the sterilization tray. ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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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).

en ► Allow the product to cool down to room tempera-

9.12 Storage

ture. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument 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. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble separable products, see Trocar assembly.

► Store sterile products in germ-proof packaging,

9.10 Packaging ► 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 sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

9.11 Steam sterilization Note The product may only be sterilized when dismantled.

protected from dust, in a dry, dark, temperaturecontrolled 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

► 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 – Disassemble the product – Steam sterilization using fractionated 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 instruments 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.

Art. no.

Designation

FH620R

MINOP InVent Trocar 30°

PE204A

MINOP Endoscope 30°

RT068R

MINOP InVent holding arm adapter

12.

Disposal

► Adhere to national regulations when disposing of

or recycling the product, its components and its packaging!

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