MINOP Trocars

en

7. ®

Safe operation

Aesculap MINOP® Trocars

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Legend

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

1 MINOP Trocar (therapeutic), FF399R 2 Single-obturator (for working channel) 3 MINOP trocar (diagnostic), FF398R 4 MINOP trocar (diagnostic), FF397R 5 Locking cap (obturator) 6 Obturator (for irrigation/drainage channels) 7 Obturator (for irrigation/drainage channels) 8 Guideway 9 Sealing caps 10 Obturator (optics and working channel) 11 Release button 12 Irrigation or drainage channel 13 Obturator (for optics channel) 14 Endoscope 15 Electrode 16 Instrument

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 instrument-side end of the optical cable of a light source! ► Apply proper care when operating the light source. CAUTION Damage to the endoscope due to incorrect handling or operation! ► Insert the endoscope in the MINOP trocar only if the trocar is not deformed, bent or kinked. Note The endoscopes offered for application with the MINOP system must be used with a light source equipped with a spare bulb!

Symbols on product and packages

7.1

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

Mounting the camera

Note Mount the camera only with the endoscope locked in the working trocar! ► Lock the endoscope in the MINOP trocar. ► Mount the camera.

1.

7.2

Intended use

Demounting the camera

The MINOP trocars are used for endoscopic examinations and therapies in the central nervous system.

Note Extract the endoscope from the working trocar only after the camera has been demounted from the endoscope!

2.

► Demount the camera from the endoscope. ► Extract the endoscope from the MINOP trocar.

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.

8.

Disassembling

8.1

Removing the obturator (for optics and working channel)

► Press the release button and carefully remove the obturator from the MINOP trocar.

3.

Contraindications

8.2

3.1

Absolute contraindications

► Turn the locking cap by 90° and carefully remove the obturator from the MINOP trocar.

None known.

3.2

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 or high protein levels within the ventricular system which limit 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.

9.

Assembling

9.1

Inserting the endoscope/obturator

► Carefully insert the endoscope/obturator in the MINOP trocar, making sure that the locking pin of the endo-

scope/obturator is on the same side as the release button of the MINOP trocar. ► Insert the endoscope/obturator down to the positive stop.

9.2

Risks and side effects

As part of the legal obligation to provide information, the following potential risks and side effects, which are known to the manufacturer and may arise during use of surgical instruments, are highlighted. These are predominantly process-specific, non-product-specific and include undesirable damage to the surrounding tissue, which can lead, for example, to bleeding, infections, material incompatibilities or instrument parts remaining unnoticed in the patient.

Removing the obturator (for irrigation/drainage channels)

Inserting the obturators (for irrigation/drainage channels)

Note Be careful not to interchange the obturators. Mind the markings, "L" (= left-hand obturator) and "R" (= right-hand obturator)! ► Hold the obturators at the distal end and carefully slide them into the respective channels, down to the positive

stop. Ensure that the guideway on the obturator is aligned with the pin in the main body of the MINOP trocar.

5.

Available sizes

► Turn the locking cap by 90°.

Designation

Art. no.

10.

MINOP trocar (diagnostic)

FF397R

10.1 General safety notes

MINOP trocar (diagnostic)

FF398R

MINOP trocar (operative)

FF399R

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

6.

Safe handling and preparation

Note For the MINOP trocar system, there are specially developed Aesculap endoscopes available. For reasons of compatibility, the MINOP trocars may only be used with these special Aesculap endoscopes! ► 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. ► For monopolar contact coagulation, make certain that the output power at the HF device does not exceed 50 W. ► To avoid burns when using the ventriculoscope in combination with HF electrodes, ensure that HF current is acti-

vated only under visual control. ► When using the HF electrode in combination with a flexible instrument, ensure that the working tips are kept as

far apart as possible. ► Set the HF device to the lowest possible output power required for the intended effect. ► Prior to each use, visually inspect the product for: damage or surface changes to the insulation. ► Never place the product on or next to the patient. ► Follow the instructions for use of the HF device.

Validated reprocessing procedure

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.

10.2 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".

10.3 Reusable products There are no known effects of processing that could lead to 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.

10.4 Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use. ► Remove the sealing cap from the Luer lock connector.

10.5 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.

10.8 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).

► 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.

► 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

10.6 Cleaning/disinfection

► 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 Tech-

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).

Product-specific safety notes on the reprocessing procedure DANGER Danger to the patient! ► 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 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 (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 allowable temperature of 55 °C. ► 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.

10.7 Mechanical cleaning/disinfection with manual pre-cleaning Note In principle, the cleaning and disinfection device must have a certified efficacy (e.g. in accordance 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:

nical Service. ► Assemble dismountable products, see Assembling.

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

10.10 Steam sterilization 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

– Disassemble the product – 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.

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

11.

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.

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 accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing.

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.

12.

Accessories/Spare parts

Art. no.

Designation

EJ751200

MINOP sealing caps for side channels (black)

PE184A

0°-optics ∅ 2.7 mm/0°/180 mm

PE204A

30°-optics ∅ 2.7 mm/30°/180 mm

PF893800

MINOP cleaning brush

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

FD–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

FD–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 FD–W: Demineralized 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.

13.

Disposal

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

TA009442

2020-08

V6

Change No. 60792