Light cable

en

2.4

AESCULAP Light cable Legend 1 2 3 4 5 6

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.

Endoscope adapter (with Aesculap/Storz connector) Endoscope-side cable end Light source adapter (with Aesculap/Storz connector) Light-source-side cable end Adapter (endoscope) disassembled Adapter (light source) disassembled

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for light cables. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

Application

DANGER Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

®

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

WARNING Burns from the hot ends of optical fibers! ► When using the product with a cold light source, make sure that the ends of the optical fibers do not touch human tissue or highly inflammable or heat-sensitive materials. ► Do not touch the distal end of the light cable. ► Only use light sources of a power rating of up to 300 W. WARNING Risk to patient due to failure of device! ► Keep an operationally ready replacement device on hand. If necessary change to conventional surgical methods. CAUTION Risk to persons and risk of damage to equipment due to improper cable routing! ► Lay all cables and leads so that they do not present a tripping hazard. ► Do not place objects on the cables ► Hold the light-source-side end of the light cable 4 against the light and check that the endoscope-side cable

end 2 illuminates evenly or use light cable tester OP917. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Available sizes

► With the light source already switched on, turn the light control to the minimum setting in order to avoid blind-

ing and heat development. ► Insert the light-source-side cable end 4 into the light source so that it audibly clicks into place. ► Screw the endoscope-side cable end 2 onto the endoscope's optical-fiber connector. ► Use the light cable only with halogen light sources equipped with a spare lamp, with xenon light sources, or with

LED light sources. ► To avoid burns caused by the hot endoscope-side end of the light cable 2, adjust the light source to the minimum

Art. no.

Version

Length

Active diameter

OP906

Standard

1.8 m

4.8 mm

OP913

Standard

2.5 m

4.8 mm

3.

Validated reprocessing procedure

OP914

Standard

3.5 m

4.8 mm

3.1

General safety instructions

OP923

Full HD

2.5 m

4.8 mm

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

2.2

Areas of use and limitations of use

2.2.1

Intended use

The light cable is used for transmitting the light from the cold light source to the endoscope in all endoscopic applications.

2.2.2

Indications

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

2.2.3

Contraindications

No known contraindications.

2.3

Safety information

2.3.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.3.2

Product

Product-specific safety information Fiber fracture of the light cable due to incorrect handling! ► Do not kink the light cable. ► Coil up the light cable to a coil with a diameter greater than 10 cm.

2.3.3

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

required power for optimal illumination of the endoscopic image. ► Always observe the respective manufacturer’s instructions when using the light cable in combination with other

devices, endoscopes, and instruments.

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 Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 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. Note If there is no final sterilization, then a virucidal disinfectant must be used. 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.

3.2

General information

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 measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for 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 the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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 of 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 surfaces 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".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Preparing for cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Disassemble the product prior to cleaning, see Disassembly. ► Coil up the light cable to a coil with a diameter greater than 10 cm. Do not kink the cable.

3.6

Disassembly

► Unscrew adapter 1 from the endoscope-side cable end 2. ► Unscrew adapter 3 from the light-source-side cable end 4.

3.7

Cleaning/Disinfection

3.9

3.7.1

Product-specific safety information on the reprocessing method

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

Damage to the optical system caused by connections coming loose in the ultrasound bath! ► Never use ultrasound treatment for cleaning a light cable. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for rigid/flexible endoscopes, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► To avoid residues/proteins becoming fixated, do not use aldehydes or alcohols for pre-cleaning. ► Only use bactericidal, fungicidal, and virucidal disinfectants. ► Preferably use thermal disinfecting processes. ► After disinfection, rinse the product thoroughly under running water. Always adhere to the manufacturer’s

Mechanical cleaning/disinfection

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.9.1

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant

instructions. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

■ working solution 0.5%

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water

3.7.2

Validated cleaning and disinfection procedure

– pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

Validated procedure

Specific requirements

Reference

IV

Thermal disinfecting

90/194

5

FD-W

-

Manual cleaning with immersion disinfection

► Do not kink the light cable. ► Leave the light cable immersed

Chapter Manual cleaning/disinfection and subsection:

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Mechanical alkaline cleaning and thermal disinfection

in the disinfectant solution for no longer than 1 hour. ► To remove residues of cleaning agents/disinfectants, always wipe the illumination surface(s) of the light cable with a swab moistened in alcohol. ► Drying phase: Use a lint-free cloth or medical compressed air

■ Chapter Manual cleaning with

► Place the product on a tray that

Chapter Mechanical cleaning/disinfection and subsection:

is suitable for cleaning (avoid rinsing blind spots).

immersion disinfection

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.10 Inspection

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.8

DW: FD–W:

Manual cleaning/disinfection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.10.1 Visual inspection ► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components.

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

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

3.8.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.10.2 Functional test

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Hold the light-source-side end of the light cable 4 against the light and check that the endoscope-side cable

end 2 illuminates evenly. –or– ► Test the transmission of the light cable with Aesculap light cable tester OP917. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.11 Assembly

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

► Screw adapter 6 onto the light-source-side cable end 4. ► Screw adapter 5 onto the endoscope-side cable end 2.

3.12 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.13 Steam sterilization CAUTION Damage to the fiber-optical system caused by flash sterilization! ► Do not flash sterilize the light cable. ► Do not expose the light cable to temperatures above 134 °C. ► 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 through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

3.14 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Coil up the light cable to a coil with a diameter greater than 10 cm. Do not kink the cable.

4.

Maintenance and service

4.1

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. 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.

4.2

Accessories / spare parts

All accessories and spare parts must only be procured from the manufacturer. Art. no.

Designation

OP917

Light cable tester

TE683R

Light cable adapter, light source end Olympus

TE684R

Light cable adapter, light source end Wolf

TE687R

Light cable adapter, endoscope end Wolf

TE688R

Light cable adapter, light source end with glass rod Olympus

Other light source and endoscope adapters are available on request from Aesculap Technischer Service, see Technical service.

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.

6.

Symbols on product and packaging Caution Observe important safety information such as warnings and precautions in the instructions for use.

Steam sterilization at temperatures up to 134 °C

Classification type CF

High level of light transmission optimized for Full HD endoscope and cameras

TA009003

2021-04

Change No. AE0060703