Reusable monopolar connecting cables

2.3.3

en

Contraindications

No known contraindications. ®

AESCULAP Reusable monopolar connecting cables 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 to reusable monopolar connecting cables. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

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: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Product description

Design variants

2.2.1

Connector

► Check the connector for compatibility with the socket of the RF device.

Monopolar connecting cables are available in the following versions: Connectors on the device Suitable e.g. for devices by

Safety information

2.4.1

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.

2.4.2

Figure/Name

Aesculap Berchtold Martin

RF instruments can cause thermal damage to the patient/user. ► Adjust the RF device to an appropriate setting to ensure that the maximum peak output voltage is equal to or lower than the rated accessory voltage specified for the product. ► Adapt the RF output power to the intended procedure. ► Select the lowest possible RF output power. ► Keep the product’s contact surfaces clean during surgery. Use a damp cloth to wipe off any dried tissue residues or body fluids. To prevent RF burns: ► Always keep the working end of the product in the user’s field of vision whenever the RF power is activated. ► Prior to activating the RF device, check that the working end of the product is not touching any electroconductive accessories. ► Prior to every use, visually inspect the product for: damage and surface changes of the insulation. ► Never place the product on or next to the patient. ► For endoscopic or laparoscopic accessories, turn off the RF automatic power-on mode. ► Observe the instructions for use of the RF device. Ambient conditions The ambient conditions listed below apply to the storage, transport and use of the product:

Aesculap Diameter 4mm Aesculap

Erbe Diameter 4mm Erbe

Temperature

-20 C to +50 C

Relative humidity

0 % to 75 %, non-condensing

Atmospheric pressure

500 hPa to 1 600 hPa

Sunlight

Keep away from direct sunlight

2.4.3

Diameter 8mm

Application

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. WARNING Risk of injury due to application of the product outside the field of view! ► Only use the product under visual control.

Connectors on the instruments Suitable e.g. for instruments by

Sterility

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

2.5 Diameter 5mm Valleylab Conmed (US Standard)

Product

Product specific safety information Sparks may be created during proper use of the HF instrument, which may lead to ignition or explosion of flammable gases. ► Observe the safety guidelines in the instructions for use of the RF device.

The product is equipped on the connector side with the following connection: see Design variants. The rated accessory voltage of the product is 4 250 Vp. The rated accessory voltage must be greater than or equal to the maximum peak output voltage at which the product is operated in combination with a suitable RF device at an appropriate operating mode/setting (see IEC/EN 606012-2).

2.2

2.4

Figure/Name

Aesculap Martin

3.

Validated reprocessing procedure

3.1

General safety instructions

Aesculap Resectoscope

Note Observe national statutory regulations, national and international standards and directives, and any proprietary hygiene instructions for processing.

Aesculap

Note Observe the applicable national regulations concerning the reprocessing of devices for patients having CreutzfeldtJakob disease (CJD), suspected of having CJD or possible variants of CJD. 11,5 mm

Bushing (diameter 4mm), unsprung Contact-free area: 11.5mm Aesculap 1,5 mm

Bushing (diameter 5 mm), unsprung Contact-free area: 1.5mm

2.3

Areas of use and limitations of use

2.3.1

Intended use

The reusable monopolar connecting cables are used to conduct the RF current from the RF device to the surgical site via a suitable instrument.

2.3.2

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.

Note Machine processing should be favored over manual cleaning as it gives better and more reliable results. Note Please note that successful processing of this medical device can only be guaranteed once the processing method has been validated. The operator/processor bears the responsibility for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFU at eifu.bbraun.com for current information on processing and material compatibility The validated steam sterilization procedure was performed using the Aesculap sterile container system.

3.2

General advice

3.8.2

Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion. Therefore, do not exceed a period of 6h 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). Using too much neutralizing agent or basic cleaners can cause chemical corrosion and/or fading, and laser markings on stainless steel may become unreadable, either visually or for the machine. For stainless steel, residues containing chlorine or chloride (e.g. surgical residues, drugs, saline solutions in water for cleaning purposes, disinfection and sterilization) can cause corrosion (pitting corrosion, stress corrosion) and eventually the destruction of the product. To remove such residues, rinse thoroughly using deionized water and then dry. Perform additional drying, if necessary. Only use process chemicals that have been tested and approved (e.g. VAH or FDA approval, or have a CE mark) and are recommended by the manufacturer of the chemicals as being compatible with the materials. Strictly adhere to any and all directions for use of the manufacturer of the chemicals. Failure to do so can result in the problems listed below: ■ Optical deterioration, e.g. fading or discoloration of titanium or aluminum surfaces. In the case of aluminum, a pH value >8 for the application solution/working solution is enough 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 as they can increase the risk of 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".

3.3

Preparation at the place of use

► If applicable, rinse surfaces that are not visible, preferably using deionized water – for instance using disposable

syringes. ► Remove any visible surgical residues as thoroughly as possible using a damp, lint-free cloth. ► Place the dry product in a sealed waste container and take it to be cleaned and disinfected within 6 hours.

3.5

Preparing for cleaning

► Immediately after use, disconnect the product first from the RF device, then from the instrument.

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

Hazardous to patients! The product may not be processed manually. ► Process the product exclusively by machine. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions, – which are approved for aluminum, plastics and high-grade steel. – 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. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

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

3.7

Machine cleaning/disinfection

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

3.7.1

3.9

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.

3.10 Steam sterilization ► 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 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.

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

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. The manufacturer provided proof of biocompatibility and processability for the product after 200 processing cycles. The product can be re-used up to 200 times with proper care and if it is undamaged and clean. Any additional reuse falls under the responsibility of the user. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection.

3.4

Functional test

► 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. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

4.

Technical service

DANGER Malfunctions and/or failure of safety measures can be life-threatening for patients and users! ► Do not perform any service or maintenance work under any circumstances while the product is being used on a patient. CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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.

5.

Accessories/spare parts

Note Information on accessories and spare/replacement parts can be found in the Aesculap brochure C-304-81.

6.

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. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.

Neutral or mildly alkaline machine cleaning and thermal disinfection

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

Step

T [°C/°F]

t [min]

Water quality

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

DI–W

Alkaline cleaning agent Working solution pH ~ 11*

III

Intermediate rinse

>10/50

1

DI–W

-

IV

Thermal disinfection

90/194

5

DI–W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfection device

The recycling pass can be downloaded from the extranet as a PDF document for each respective part number. (The recycling pass is a dismantling instruction of the device with information on the proper disposal of environmentally harmful components.) Any product labeled with this symbol must be disposed of separately together with electrical and electronic equipment. Within the European Union the manufacturer shall take care of the disposal free of charge.

Chemical/Comment

D-W: DI–W:

Potable water De-ionized water (demineralized, microbiological at least in compliance with potable water regulations) * Dr. Weigert neodisher® MA was used to prove cleanability.

► Detailed information concerning the disposal of the product is available from your national B. Braun/Aesculap

representative, see Technical service.

7.

Technical data

7.1

Classification in accordance with Regulation (EC) 2017/745

Designation

Class

Reusable monopolar connecting cables

I

7.2

Performance data, information on standards

► Check visible surfaces for residue after machine cleaning/disinfection.

Rated accessory voltage

4 250 Vp

3.8

Compliance with standards

IEC/EN 60601-1

Inspection

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

3.8.1

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. ► Check the product for missing or faded labels. ► Check products having long, narrow geometries (in particular rotating instruments) for deformations. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► 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.

TA022291

2021-03

Change No. 63662