ELAN 4 electro remote foot control GA810

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A2

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Aesculap® ELAN 4 electro remote foot control GA810 Legend 1 2 3 4 5 6 7

Pump selector

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

Changing the maximum speed

Class AP equipment according to IEC/DIN EN 60601-1

US federal law restricts the supply of the product exclusively to or by order of a physician

Symbols on product and packages

Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Disposal

Caution Observe important safety information such as warnings and precautions in the instructions for use. Manufacturer

Date of manufacture

SN

Manufacturer serial number

LOT

Manufacturer's batch name

REF

Manufacturer’s article number

QTY

Delivery quantity Non-sterile medical product

CE mark according to Regulation (EU) 2017/745

EAC symbol of the Eurasian Economic Union Medical device

Temperature limits during transport and storage

Atmospheric pressure limits during transport and storage

Air humidity limits during transport and storage

Preselection of motor rotation direction

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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 9.7 10. 11. 12. 13.

About this document... Scope... Safety instructions... General information... Intended use... Application Environment... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation and setup... First use... Working with the product... 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... Manual cleaning including immersion disinfection (recommended for heavily soiled objects)... Inspection, maintenance and checks... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts...

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en 14.1 14.2 14.3 15.

1.

Classification according to Regulation (EU) 2017/745... Basic data, information about standards... Ambient conditions... Disposal...

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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 the ELAN 4 electro remote foot control GA810. ► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety instructions

Safety instructions specify the dangers to patient, user and/or product that can occur during the use of the product. Safety instructions are labeled as follows: DANGER Indicates a potential hazard. If not avoided, death or serious injury may result. WARNING Indicates a potential hazard. If not avoided, minor or moderate injury may result. CAUTION Indicates a potential threat of material damage. If not avoided, the product may be damaged.

2.

General information

2.1

Intended use

The ELAN 4 electro remote foot control GA810 is an accessory for the ELAN 4 electro motor system. With the remote foot control: ■ the user activates the motor of the applied part and selects the rotational direction, ■ the user activates/deactivates the coolant and irrigation pump, ■ the user can change the maximum speed of the motor.

3.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only according to its intended use. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory for 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.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

Note The ELAN 4 electro remote foot control GA810 cannot be used if a manually controlled applied part or a cable-connected foot control is used.

GA810

ELAN 4 Electro remote foot control

TA014411

Instructions for use of remote foot control GA810 (brochure)

2.2

4.2

Application Environment

Application in the unsterile area Remote 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

Components required for operation

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

Floor

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en 4.3

Operating principle

With the ELAN 4 electro remote foot control GA810 the active applied part is connected to the control unit without manual control. The coolant and irrigation pump is activated or deactivated and the maximum speed and direction of the applied part is changed. Function button 2: Short actuation

Prolonged Pressing

Activation/deactivation of the coolant and irrigation pump. The pump only operates when the motor is running. Flush function The pump will operate until the actuation is stopped.

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. Maximum speed button 5: The maximum speed button is for step-by-step changes to the set maximum speed on the control device GA800 with full operation of the pedal.

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 6, see Fig. A2. ► Widen the transport brace 1 and insert it into the other holding receptacle for transport brace 6. Make certain that the transport brace is correctly mounted. Note Disassembly is carried out in the reverse order.

6.

Working with the product

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. ► Remove pedal 3 from the guide bolts for pedal 7. ► Remove the pedal 3 in an upward direction, see Fig. C.

8.

Mounting the pedal (after cleaning)

► Insert pedal 3 onto guide bolts for pedal 7, see Fig. B. ► Fold pedal 3 down.

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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 life time of the product is limited due to damage, normal wear and tear, type and duration of use, in addition to the handling, storing and transporting of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

9.3

Preparation before cleaning

► 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.

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. Note If the product is heavily soiled, Aesculap recommends manual cleaning including immersion disinfection.

en 9.5

Wiper disinfection for electrical equipment

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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 *Recommended: Meliseptol® Wipes sensitive (B. Braun)

► Disassemble pedal for cleaning, see Disassembling the pedal for clean-

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

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

9.6

Manual cleaning including immersion disinfection (recommended for heavily soiled objects)

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Disinfecting cleaning

RT (cold)

>15

2

P–W

Concentrate free from aldehydes, phenols and QAV, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

P–W

-

III

Disinfection

RT (cold)

15

2

P–W

Concentrate free from aldehydes, phenols and QAV, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

DI-W

-

V

Drying

RT

-

-

-

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P–W: Potable water DI-W: de-ionized water (demineralized, microbiological at least in compliance with potable water regulations) RT: Room temperature *Recommended: BBraun Stabimed

► Disassemble pedal for cleaning, see Disassembling the pedal for clean-

ing. Phase I ► Immerse product at least 15min completely in the actively cleaning

disinfecting solution. Ensure that all accessible surfaces are wetted. ► Clean the product in the solution using a suitable cleaning brush until

no residue is visible on the surface. Phase II ► Rinse product completely (all accessible surfaces) under running water. ► Allow sufficient time for water to drip off.

9.7

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. ► Change battery when the energy level is low:

– Remove the 4 screws on the bottom of the device with a screwdriver (Torx TX20). – Remove the cover of the battery compartment. Replace batteries (3x) (battery type D / LR20 / Mono). – Note the polarity of the batteries. – Replace the battery compartment cover and secure with 4 screws.

Phase III ► Completely immerse the product in the disinfectant solution.

Phase IV ► Rinse/flush product completely (all accessible surfaces). ► Allow sufficient time for water to drip off.

Phase V ► During the drying phase dry the product using the appropriate equip-

ment (e.g. wipes, compressed air).

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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 according to Regulation (EU) 2017/745

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

Art. no.

Name

Class

GA810

ELAN 4 electro remote foot control

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14.2 Basic data, information about standards For connection to

ELAN 4 electro control unit GA800

Degrees of protection in accordance with IEC/ DIN EN 60601-1

AP

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.

Degrees of protection provided by enclosure according to IEC/ EN 60529

IPX8

Weight

3810 g ±10 %

Dimensions (L x W x H) without transport bracket

271 mm x 266 mm x 85 mm ±10 %

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.

Dimensions (L x W x H) with transport bracket

271 mm x 310 mm x 200 mm ±10 %

Compliance with standards

IEC/DIN EN 60601-1

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.

EMC

IEC/DIN EN 60601-1-2

Battery type

D / LR20 / Mono (3 x)

Radio standards

ETSI EN 300 440 ETSI EN 301 489-1 ETSI EN 301 489-3 IEC/DIN EN 62311

ISM band

2 403 MHz to 2 480 MHz

CISPR11

Class A

12. Technical Service

13. Accessories/Spare parts Art. no.

Name

TA014411

Instructions for use for ELAN 4 electro remote foot control GA810 (brochure)

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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 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 Processing procedure. The recycling passport can be downloaded from the extranet as a PDF document using the individual part number. (The recycling passport is a disassembly instruction for the equipment containing information on the proper disposal of environmentally harmful components.) A product marked with this symbol must be disposed separately with electrical and electronic equipment. Within the European Union the manufacturer performs the disposal free of charge. ► 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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