ELAN 4 electro foot control GA808

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Aesculap® ELAN 4 electro foot control GA808 Legend

Temperature limits during transport and storage

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Air humidity limits during transport and storage

Transport brace Function button Pedal Rotational direction button for motor Holding receptacle for transport brace Guide pins for pedal

Atmospheric pressure limits during transport and storage

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use. Manufacturer combined with date of manufacture (year)

SN

Manufacturer’s serial number Preselection of motor rotation direction

Pump selector

Class AP equipment in accordance with IEC/DIN EN 60601-1 Labeling of electrical and electronic equipment in accordance with Directive 2012/19/EC (WEEE), see Disposal

Date of manufacture

LOT

Manufacturer’s batch designation

REF

Manufacturer’s order number

QTY

Delivery quantity Non-sterile medical device

According to federal law, this product may only be sold by or by the order of a physician CE marking in accordance with Regulation (EC) 2017/745 Medical device

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Contents 1. 1.1 1.2 2. 2.1 2.2 3. 4. 4.1 4.2 4.3 5. 5.1 6. 7. 8. 9. 9.1 9.2 9.3 9.4 9.5 9.6 10. 11. 12. 13. 14. 14.1 14.2 14.3 15.

About this document... Scope... Warnings... General information... Intended purpose... Application Environment... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation and setup... First use... Working with the ELAN 4 electro foot control... Disassembling the pedal for cleaning... Mounting the pedal (after cleaning)... Processing procedure... General safety notes... Reusable products... Preparation before cleaning... Cleaning/disinfection... Wiper disinfection for electrical equipment... Inspection, maintenance and checks... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745 . . Basic data, information about standards... Ambient conditions... Disposal...

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en 1.

About this document

Note General risks of surgical interventions are not described in these instructions for use.

1.1

Scope

These instructions for use apply to the ELAN 4 electro foot control GA808. ► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may emerge during the use of the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. If it is not prevented, minor or moderate injuries may result. CAUTION Indicates a potential damage to property. If it is not avoided, the product may be damaged.

2.

General information

2.1

Intended purpose

The ELAN 4 electro foot control GA808 is an accessory of the ELAN 4 electro motor system. With the foot control: ■ the user activates the motor of the applied part and selects the rotational direction, ■ the user activates or deactivates the cooling or flushing liquid pump, provided that a hand controlled applied part is not being used. Cable length

2.2

3.

Safe handling

WARNING Risk of injury and material damage due to inappropriate use of the product! ► Use the product only in accordance with the intended purpose. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the ELAN 4 electro control unit GA800. ► Follow the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► Follow the instructions for use of all products used.

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

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.

■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► 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 manufacturer 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. Note The user agrees to report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

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Application Environment

Application in the unsterile area 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. Set-up location

Floors

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en 4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA808

ELAN 4 electro foot control

TA014409

Instructions for use of foot control GA808 (leaflet)

6.

Working with the ELAN 4 electro foot control

How to work with the ELAN 4 electro system and its accessory components is described in the instructions for use of the ELAN 4 electro control unit GA800, see TA014401.

7.

Disassembling the pedal for cleaning

► Lift the pedal 3 upwards, see Fig. B.

4.2

Components required for operation

► Remove pedal 3 from the guide bolts for pedal 6.

■ ELAN 4 electro control unit GA800 ■ ELAN 4 electro motor cable for foot control GA806 ■ ELAN 4 electro applied part ■ Tool

► Remove the pedal 3 in an upward direction, see Fig. C.

4.3

► Fold pedal 3 down.

Operating principle

The ELAN 4 electro foot control GA808 is used to activate the active application part connected to the control unit without manual control. The cooling or flushing liquid pump activates or deactivates. Function button 2: Short actuation

Turns the cooling or flushing liquid pump on and off. The pump only works when a motor is running

Longer actuation

Flush function The pump operates until activation is ended.

Rotational direction button for motor 4: Selection of right or left rotation. Pedal 3: The pedal serves as the actuator for the speed setting of the control unit. Depending on the actuating path, the speed of the motor can be selected continuously from 0 to the maximum speed set.

5.

Preparation and setup

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.

5.1

First use

Assembling/disassembling the transport brace ► Insert transport brace 1 on one side into the holding receptacle for transport brace 5, see Fig. A. ► Widen the transport brace 1 and insert it into the other holding receptacle for transport brace 5. Make certain that the transport brace is correctly mounted. Note Disassembly is carried out in the reverse order.

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8.

Mounting the pedal (after cleaning)

► Insert pedal 3 onto guide bolts for pedal 6, see Fig. B.

9.

Processing procedure

9.1

General safety notes

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

9.2

Reusable products

The service life of the product is limited by damage, normal wear, the nature and duration of the application, and handling, storage and transportation of the product. Careful visual and functional testing prior to the next use is the best way to identify a malfunctioning product.

9.3

Preparation before cleaning

► Separate the products from each other immediately after use. ► Remove any visible surgical residues as much as possible with a damp,

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

Note The pedal can be removed for cleaning, see Disassembling the pedal for cleaning.

en 9.4

Cleaning/disinfection

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.

9.5

Wiper disinfection for electrical equipment

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT

1

-

-

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

II

Wipe disinfection

RT

≥1

-

-

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

RT: Room temperature * Validation was performed using Meliseptol® wipes sensitive (B.Braun)

Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable

disinfectant wipe. ► Observe contact time (at least 1min).

9.6

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.

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en 10. Maintenance

14. Technical data

To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

14.1 Classification in accordance with Regulation (EC) 2017/745

11. Troubleshooting list Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

12. 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/Aesculapagency. 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.

13. Accessories/Spare parts Art. no.

Name

TA014408

Instructions for use for ELAN 4 electro foot control GA808 (A4 for ring-binder)

TA014409

Instructions for use of ELAN 4 electro foot control GA808 (leaflet)

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Art. no.

Name

Class

GA808

ELAN 4 electro foot control

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14.2 Basic data, information about standards For connection to

ELAN 4 electro control unit GA800

Protection class according to IEC/ DIN EN 60601-1

AP

Enclosure protection class accord- IPX8 ing to IEC/ DIN EN 60529 Weight

2240 g ±10 %

Dimensions (L x W x H) without transport brace

245 mm x 143.7 mm x 75.5 mm ±10 %

Dimensions (L x W x H) with trans- 245 mm x 193.5 mm x 196.4 mm port brace ±10 % Cable length (without connector)

5.0 m ±5 %

Conforming to standard

IEC/EN 60601-1

EMC

IEC/DIN EN 60601-1-2

14.3 Ambient conditions Operation

Transport and storage

Temperature

10 °C to 40 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

en 15. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing or recycling the product, its components and their packaging. Note The user institution is obliged to process the product before its disposal, see Processing procedure. 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 free-of-charge service. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

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