Single foot switch

en

2. ®

Aesculap Single foot switch Legend A HF foot switch plug in connection socket HF foot switch B JET foot switch plug in connection socket JET foot switch (GN090)

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

Safe handling

► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► 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. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-

ufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Follow the instructions for use of the Aesculap device/accessory. Note The user is obligated to report all of the severe events in connection with the product to the manufacturer and the competent state authorities in which the user is located.

Manufacturer

Date of manufacture

Manufacturer’s article number

Manufacturer’s batch designation

Delivery quantity

3.

Product description

3.1

Scope of supply

Designation

Art. no.

Single foot switch

GK226/GN092/GN161

Instructions for use of single foot switch

TA022226

3.2 Components required for operation ■ Aesculap device ■ Single foot switch ■ Accessories 3.2.1

Non-sterile medical product

Compatibility list

WARNING Risk of injury and/or malfunction of the product due to unauthorized device/foot switch combination! ► Observe the compatibility list. Single foot switch GK226/GN161

According to US federal law, this device may only be sold by or on the orders of a doctor CE-approved in accordance with Directive (EU) 2017/745

EAC symbol of the Eurasian Economic Union

Designation

Art. no.

Bipolar electrosurgical generator

GN060

JET irrigation unit (connection socket HF foot switch)

GN090

Bipolar electrosurgical generator

GN160

Nelsonbibox

GN310

HF-surgical generator Nelsondeluxe (< SN 2000)

GN640

Device Class AP

Single foot switch GN092 Housing protection class according to IEC/DIN EN 60529 Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Disposal

Designation

Art. no.

JET irrigation unit (connection socket JET foot switch)

GN090

Note Information concerning other compatible Aesculap devices is available on request and can be found in Aesculap brochure C-304-81.

3.3

1.

About this document

Note General risk factors associated with surgical procedures are not described in this documentation.

3.4

1.1

3.5

Scope

These usage instructions apply for the following products:

Intended use

The single foot switches GN161 and GK226 are used for activating compatible Aesculap devices for HF surgery. The single foot switch GN092 is used for activating the JET function of the JET irrigation unit (GN090). The foot controls are Class AP devices. The foot control circuit is ignition-safe and approved for operation in medical environments according to IEC/DIN EN 60601-1. The housing is constructed according to Protection Type IPX8.

Absolute contraindications

No known absolute contraindications.

Relative contraindications

The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities, coagulation status) which could hinder the success of the operation. In the presence of relative contraindications, the user decides individually regarding the use of the product.

Art. no.

Designation

GK226

FOOTSWITCH F.BIPOLAR DEVICE GN060

GN092

SANO FUSSPEDAL ZU GN090

3.6

GN161

FOOTSWITCH FOR GN060 AND GN160

The single foot switches are placed on the floor and plugged in at a compatible Aesculap device. Pressing the single foot switch creates a switching status that is recognized by the Aesculap device and results in its activation (HF output/JET function). The circular form factor of single foot switch GN161 allows its operation from different positions.

► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Operating principle

Warnings

Warnings make clear the dangers to patient, user and/or product that could arise during the use of the product. Warnings are labeled as follows: DANGER Danger. If not avoided, death or severe injuries may result. WARNING Danger. If not avoided, minor or moderate injuries may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national regulations on fire and explosion protection. WARNING Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device. ► Connect single foot switch to Aesculap device, see instructions for use of the Aesculap device.

5.

Working with the single foot switch

5.1

System set-up

5.1.1

Connecting the accessories

Phase I ► Remove any visible residues with a disposable disinfectant wipe.

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. Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

5.1.2

Connecting the single foot switch

WARNING Risk of burns to the patient caused by inadvertent activation of the Aesculap device when connecting a defective single pedal foot switch! ► Always carry out a function check prior to using the product. ► Connect the HF cable and the instrument only after connecting the single foot switch. There are two arrows given as markings, one on the HF foot switch plug and the other on the HF foot switch connection socket of the Aesculap device. The arrows must point to each other when connecting the single foot switch, see Fig. A. ► Plug in the foot switch plug at the foot switch connection socket of the Aesculap device, see Fig. A and Fig. B.

5.2

Function checks

► Check that the accessories do not show any visible damage. ► Switch the Aesculap device to ready status, see instructions for use of the Aesculap device. ► Check that no HF instrument is connected to the Aesculap device. ► Function tests:

– Connect the plug of the single foot switch at the foot switch connection socket of the Aesculap device, but do not press the foot switch. Expected reaction of the device: No activation. – Press the single foot switch. Expected reaction of the device: Activation of HF or JET. – Release the single foot switch. Expected reaction of the device: Activation of HF or JET is stopped. Note Device reactions at variance with those listed above may indicate a fault of the Aesculap device or the single foot switch, or both. If possible repeat the test with another Aesculap device!

5.3

Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the application time (1 min minimum).

6.6

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

7.

Technical Service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. ► Do not modify the product. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► 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) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

8.

Technical data

GK226/GN092/GN161

Single foot switch

Housing protection class according to IEC/DIN EN 60529

IPX8

Protection class (acc. to IEC/DIN EN 606011)

Class AP ignition-safe, authorized for use in medical environments Applies to foot switch circuit in combination with Aesculap devices

Safe operation

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

Weight

WARNING Risk of burns to the patient due to inadvertent activation of the Aesculap device! ► Immediately switch off the Aesculap device at the mains power OFF switch. ► Operate the single foot switch with appropriate caution. WARNING Hazard risks due to inadequate preparation or faulty Aesculap device! ► Ensure that the Aesculap device is fully operational without fault. ► Check that no conductive fluids (e.g. blood, amniotic fluid) have entered the single foot switch. ► Check that there is no short circuit in the single foot switch or the foot switch cable. ► Press the single foot switch.

1 100 g

GN161

665 g

GK226, GN092

Dimensions (L x W x H)

225 mm x 190 mm x 34 mm

GK226, GN092

Dimensions (∅ x H)

170 mm x 37 mm

GN161

EMC (in combination with Aesculap device)

IEC/DIN EN 60601-1-2

Conforming to standards (in combination with Aesculap device)

IEC/DIN EN 60601-1 IEC/DIN EN 60601-2-2

Classification acc. to Directive (EU) 2017/745 Art. no.

Designation

Class

GK226 GN092 GN161

Single foot switch

IIb

The Aesculap device is activated.

6.

Reprocessing procedure

6.1

General safety information

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

8.1

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com

Temperature

6.2

Preparation before cleaning

Storage and transport

Relative humidity

Atmospheric pressure

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

6.4

Cleaning/disinfection

6.4.1

Product-specific safety instructions for the reprocessing procedure

CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances. CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

6.5

Operation

Reusable products

Influences from processing that result in damage to the product are unknown. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

6.3

Ambient conditions

Note The atmospheric pressure of 700 hPa corresponds to a maximum operating altitude of 3 000 m.

9.

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 process the product before its disposal, see Reprocessing procedure.

Wipe disinfection for electrical devices

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

RT

1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a freeof-charge service.

II

Wipe disinfection

RT

≥1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

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

agency, see Technical Service. RT: *

Room temperature Validation was performed with Meliseptol® wipes sensitive (B. Braun)

TA022226

2019-09

V6

Change No. 61022