MINOP optics and angled optics Instructions for Use

en

The following table shows the approved combinations of endoscopes, sheaths, and working trocars: ®

AESCULAP MINOP optics and angled optics Legend 1 Distal window 2 Sheath 3 Optical cable connection 4 Illumination surface of the optical cable connection 5 Eyepiece housing 6 Eyepiece window 7 Inscription ring 8 ACMI adapter (fixed) 9 Wolf adapter 10 Storz adapter 11 Color ring

Symbols on product and packages

Insert the endoscope

Sheath and working trocar

PE184A

FF397R, FF398R, FF399R, FH601R

PE204A

FF397R, FF398R, FF399R, FH620R

► Do not use the 2.7 mm endoscopes PF184A and PF204A without trocar.

8.

Safe operation

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

8.1

Function checks

► Check the optical function of the endoscope. The image has to be clear and distinct. ► Ensure that the distal window 1, the eyepiece window 6 and the illumination surface 4 of the optical cable

connection 3 are not cloudy, dirty or scratched. ► Hold optical cable connection 3 of the endoscope against the light and check that the light fibers at the distal

end light up evenly. ► Inspect the sheath for dents, bends, and scratches.

Steam sterilization at temperatures up to 134 °C

8.2

Low temperature and plasma sterilization

Endoscopes are compatible with FULL HD camera systems

1.

Applicable to

► For article-specific instructions for use as well as information on material compatibility see B. Braun eIFU at

eifu.bbraun.com

2.

Intended use

MINOP optics and angled optics are used for visualizing the ventricles and other structures in the brain, as well as structures at the spine. The following MINOP and angled optics are approved for direct contact with the central nervous system: ■ PE184A ■ PE204A ■ PE486A ■ PE506A ■ PE526A

3.

For indications, see Intended use.

4.

Absolute contraindications

No known absolute contraindications.

5.

Relative contraindications

To our current knowledge there are no product specific relative contraindications. Yet, there are medical or surgical conditions that may hinder the endoscopic technique, such as major bleeding or high protein concentration within the ventricular system, which disturb the vision. In the case of relative contraindications, the user decides individually on the use of the product.

6.

Available sizes

The rigid, autoclavable neuroendoscopes are available in the following sizes and designs: ■ Sheath ∅ 2.7 mm and 4.0 mm ■ Angled endoscopes

7.

WARNING Burns suffered by patient or user from exposure to high light intensity! ► Make certain the distal end of the endoscope or optical cable connection does not touch human tissue or any flammable or heat-sensitive materials while the light source is active. ► Do not put down the endoscope on the patient. ► Do not touch the distal end of the endoscope and the optical cable connection. ► Do not leave the endoscope shaft in one position for a long time (> 10 minutes) in situations in which it can come into direct contact with body tissue (e.g. tight anatomical spaces). ► Adjust the light source to the minimum required power for optimal illumination of the endoscopic image. ► Only use light sources of up to 300 W electric power. CAUTION Damage to the endoscope by bending the endoscope sheath! ► Do not bend the endoscope sheath. ► Use the endoscope with its appropriate sheaths and working trocars only. ► Always hold the endoscope at the eyepiece housing but never at the sheath. ► Use endoscopes only with halogen light sources equipped with a spare lamp or with xenon light sources. ► Observe the respective manufacturer’s instructions when using the endoscope in combination with other equip-

Indications

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

Safe handling and preparation

Use of the endoscope

WARNING Burns caused by high-frequency current (HF current)! ► When using an endoscope and HF electrodes at the same time, be cautious to activate the HF current under visual control only. ► Ensure that the active electrode is never in the immediate vicinity of electrically conductive components (e.g. trocar, endoscope).

ment, instruments, or optical cables.

9.

Disassembling

► Unscrew adapter 9 or 10, respectively, from the endoscope.

10.

Assembling

► Screw adapter 9 or 10, respectively, onto the endoscope.

11.

Validated reprocessing procedure

11.1 General safety notes 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 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.

This manual contains instructions for the preparation, reprocessing, and disposal of the endoscope. It does not contain information on the actual application of the endoscope.

Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

WARNING Risk of injury from defective endoscopes! ► Only use an endoscope if it is in perfect condition.

11.2 General information

The products are supplied in an unsterile condition and must be reprocessed and sterilized prior to use. ► 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. ► When using the endoscope in combination with any electromedical device, make sure that the respective BF conditions are adhered to (insulated, floating patient application piece). ► 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). ► Make certain a reserve product is available. ► Do not, under any circumstances, put down the product on the patient or on the surgical drape covering the patient. Note The applied parts according to IEC 60601-1 can reach temperatures of > 41 °C up to 49 °C (tested at an ambient temperature of 40 °C).

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 dosages of neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking on stainless steel 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 in the destruction of stainless steel 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: ■ Optical changes in 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 surface 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 "AKI-Brochures", "Red brochure".

11.3 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 covers from the Luer lock connectors and the sealing cap from the working channel. ► Open all valves/faucets.

11.4 Preparations at the place of use

11.10 Steam sterilization

► If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),

Note Alternating sterilization by different sterilization processes can result in damage to materials and adapters of the product.

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.

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

11.6 Cleaning/disinfection Product-specific safety notes on the reprocessing procedure DANGER Danger to the patient! The product must not be manually reprocessed. ► Reprocess the product only by cleaning in a mechanical washer/disinfector with or without manual precleaning. DANGER Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray.

► For prion inactivation, clean/disinfect the endoscope mechanically using a prion-inactivating cleaning agent. ► 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. ► Ensure that the bend radius of the flexible lines of the product is at least 11 cm. ► Avoid excessive pressure on the product.

11.7 Mechanical cleaning/disinfection Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound1) T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Alkaline cleaner

Neutralization3)

>10/50

2

opening any valves and faucets). ► Do not autoclave damaged products. ► Protect the products against mechanical impacts.

Note Aesculap guarantees steam sterilization of the product up to 50 autoclave cycles at a holding time of 18 min. ► Validated sterilization process

– Steam sterilization using the 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 5 min Note The product is also suitable for sterilization at 134 °C, holding time 18 min. ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-

ity of the steam sterilizer specified by the manufacturer is not exceeded.

Sterrad® sterilization process Sterrad® 50, Sterrad® 100S, Sterrad® 200 Note The Sterrad® sterilization process can cause cosmetic changes to the product. These changes will, however, not affect its functionality. Note The product must be disassembled prior to sterilization through the Sterrad® process. ► Disassemble the product. ► Only sterilize endoscopes carrying the SDS symbol for low-temperature and plasma sterilization on the inscrip-

tion ring 7 by means of the Sterrad® sterilization process 50, 100S, 200. ► Unscrew dismountable parts of the endoscope, see Disassembling. ► Sterilize using the Sterrad® sterilization process 50, 100S, 200. When doing so, observe the following: Follow the

Sterrad® system manufacturer's instructions. Use of a biological indicator is recommended to confirm effective sterilization.

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

12.

FD-W

Maintenance

Utility solution pH ~ 11

The product requires no maintenance for the first 50 autoclave cycles at a holding time of 18 min. After that, the image quality of the product can be diminished by normal wear during steam sterilization.

B. Braun Helimatic® Neutralizer C 0,15 % working solution

13.

2)

III

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

Note The product can be steam-sterilized either in disassembled or in assembled condition.

CAUTION Damage to the optical system caused by loosening of connections during ultrasound cleaning! ► Do not clean the endoscope with ultrasound.

Step

CAUTION Damage to the optical system caused by flash sterilization! ► Do not flash sterilize the endoscope. ► Do not expose the endoscope to temperatures above 134 °C.

Steam sterilization

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 do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

Phase

The following processes can be used to sterilize the endoscope: ■ Steam sterilization ■ Sterrad® sterilization process: using Sterrad® sterilizers Sterrad® 50, Sterrad® 100S, or Sterrad® 200

IV

Intermediate rinse I

>10/50

1

FD–W

-

V

Intermediate rinse II3)

>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

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.

D–W: FD–W: 1) 2) 3)

Drinking water Fully desalinated water The following cleaning and disinfection devices were used to verify cleanability: Miele PG 8535 Dr. Weigert neodisher® SeptoClean was used to verify cleanability. Due to the high pH value of the cleaner, the neutralization and the second intermediate irrigation was used.

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

11.8 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) at the marked lubrication points, using 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 instrument is dry, clean, operational,

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Inspect surfaces, cavities, lumens and openings for visible debris. ► 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. ► For products with locking mechanism (e.g. MINOP): Check the locking mechanism for smooth movement. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

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

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Prior to dispatching the product for repairs: – Have the product cleaned and disinfected or sterilized, and mark it as “disinfected” or “sterilized”, respectively. – Pack the endoscope in such a way that it will be protected against transport damage. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1601 Fax: +49 (7461) 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

14.

Disposal

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

TA013238

2021-04

Change No. 62968