Foot control with pedal and two buttons

Contents 1. 2. 2.1 2.2 2.3 3. 3.1 4. 4.1 4.2 4.3 5. 5.1 5.2 5.3 5.4 5.5 5.6 6. 7. 8. 9. 9.1 10. 11.

Safe handling Product description Scope of supply Intended use Operating principle Preparation and setup First use Working with the foot control GA188 System set-up Function checks Safe operation Validated reprocessing procedure General safety instructions General information Preparations at the place of use Cleaning/disinfection Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Maintenance Troubleshooting list Technical Service Technical data Ambient conditions Disposal Distributor in the US/Contact in Canada for product information and complaints

1. 3 4 4 4 4 5 5 5 5 6 6 7 7 8 8 8 9 9 9 9 10 10 11 11 11

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

WARNING

Risk of injury and damage to property due to improper handling of the product! This product is an accessory of a medical device. ► Follow the instructions for use of the medical device (ELAN EC, ELAN EC VETline). ► Follow the instructions for use of all products used. 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.

► 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. – Adhere to application instructions according to relevant norms. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience.

3

Aesculap® Foot control with pedal and two buttons ► Keep the instructions for use accessible for the

2.3

user. ► Always adhere to applicable standards

Selection of the rotational direction

2.

Product description

2.1

Scope of supply

Operating principle

The rotational direction is selected by means of the motor direction changeover switch 2. Clockwise

Art. no.

Designation

GA188

Foot control with pedal and two buttons

TA008142

2.2

Instructions for Use

Intended use

Foot control GA188 is used for control and activation of ELAN EC and ELAN EC VETline control unit (GA830, GA835, GA840, GA845). 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 IP67.

Type and areas of application The area of application depends on the flexible shaft, handpiece and tool used. Processing of hard and soft tissue in: ■ Large-bones sugery (hip and knee prostheses, traumatology, cardiac and thoracic surgery) ■ Small-bones surgery (OMF, hand and foot surgery) ■ Mircosurgery (ENT, neurosurgery, spine surgery)

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The motor direction changeover switch 2 is not pressed. The clockwise torque indication of the control unit is on. Counterclockwise The motor direction changeover switch 2 is pressed. The counterclockwise torque indicator of the control unit is on.

Motor speed control The pedal (for motor speed control) 5 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 maximum speed.

Control of the coolant pump The coolant pump of the control unit is switched on and off using the pump switch 3.

Activation of the coolant pump The coolant pump only works when a motor is running. The switched on coolant pump is activated with the pedal for motor speed control parallel to the motor. The delivery rate of the coolant is adjusted on the control unit.

3.

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, – the national regulations on fire and explosion protection, – Instructions for use according to IEC/DIN EN regulations.

3.1

Working with the foot control GA188

4.1

System set-up

WARNING

Risk of injury and material damage due to inadvertent activation of the motor

■ due to inadvertsent activation of the foot control or

■ due to a defect in the foot control or the device! ► Do not store handpiece

First use

WARNING

4.

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.

Mount the transport brackets

within reach of the patient. ► Hold the tool at its shaft and do not touch the cutting edges when coupling/ uncoupling a tool. ► Place the foot control in such a way that the pedal is not activated or pinched inadvertently.

► Insert the transport brackets 1 on one side into the

insertion bore 4. ► Widen the transport brackets 1 and insert into the

other insertion bore 4. ► Ensure that the transport brackets engages cor-

rectly.

5

Aesculap® Foot control with pedal and two buttons Connecting/Disconnecting the foot control Note The chapter on connecting/disconnecting the foot control is a component of the instructions for use for the control unit (ELAN EC, ELAN EC VETline). ► Connecting the foot control to the control unit:

Align the connection plug 6 and plug into control cable socket A (back panel) until it clicks into position, see Fig. 1. ► To remove the foot control from control unit: Press the ratchet lever B and remove connection plug 6 at the same time, see Fig. 1.

B

A

Legend 6 Connection plug A Control cable socket (connection socket for foot control) B Ratchet lever C Alignment screw

4.2

Function checks

► Prior to each use, check that the entire unit is in

good working order. ► Ensure that the parameters and operation are car-

ried out in accordance with the instructions for use and safety information for all components used. ► Ensure that all components to be used function properly and are properly connected. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

4.3

Safe operation

C WARNING

6 C

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

Select rotational direction Note The motor direction changeover switch does not work if the control unit is used in combination with a macroflexible shaft. Independently of the switch position, the motor operates in clockwise rotation. ► Select clockwise rotation mode. In doing this,

Fig. 1 6

ensure that the motor direction changeover switch 2 is not pressed. The clockwise torque indicator of the control unit is on. ► Select counterclockwise rotation mode. Also press the motor direction changeover switch 2. The counterclockwise torque indication is on.

To activate/deactivate coolant pump Note Only useable in combination with ELAN EC GA835 or ELAN EC VETline GA845. ► To switch on coolant pump: Press pump switch 3.

Indicator Pump On of the control unit is lit. ► Switch off the coolant pump: Pump switch 3 not

pressed. Indicator Pump On of the control unit is not lit.

Activate motor or coolant pump ► Activate pedal 5 for motor speed control.

When counterclockwise rotation is selected, the control unit emits an audible signal. Switched-on coolant pump is activated parallel to the motor.

5.

Validated reprocessing procedure

5.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. 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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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Aesculap® Foot control with pedal and two buttons 5.2

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.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

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5.3

Preparations at the place of use

► Remove any visible surgical residues to the extent

possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste con-

tainer for cleaning and disinfection within 6 hours.

5.4

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

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. 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.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Wipe disinfection for electrical devices without sterilization

■ When cleaning instruments with movable hinges,

Chapter Chapter Wipe disinfection for electrical devices without sterilization

5.5

ensure that these are in an open position and, if applicable, move the joint while cleaning.

Wipe disinfection for electrical devices without sterilization

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Wipe disinfection

RT

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

RT:

Room temperature

6.

Phase I ► Remove any visible residues with a disposable dis-

infectant wipe. ► Wipe all surfaces of the optically clean product

with a fresh, disposable disinfectant wipe. ► Observe the specified application time (1 min min-

imum).

5.6

Inspection, maintenance and checks

► Inspect the product after each cleaning and disin-

fecting cycle to be sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

Maintenance

This product is an accessory of a medical device. In order to guarantee reliable operation, maintenance must be carried out at least once a year in accordance with the instructions for use for the medical device (GA830, GA835, GA840, GA845). For relevant services contact your national B. Braun/ Aesculap agency, see Technical Service.

7.

Troubleshooting list

► See instructions for use for the control unit

(ELAN EC or ELAN EC VETline).

9

Aesculap® Foot control with pedal and two buttons 8.

Technical Service

WARNING

Risk of injury and/or malfunction! ► Do not modify the product.

9.

Technical data

Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GA188

Foot control with pedal and two buttons

I

► For service and repairs, please contact your

national B. Braun/Aesculapp agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. 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] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

GA188 For connection to surgery motor

- GA830 - GA835 - GA840 - GA845

Safety rating (in accordance with IEC/DIN EN 60601-1)

AP

Housing protection class according to IEC/DIN EN 60529

IP67

Weight

approx. 2.0 kg

Dimensions (L x W x H)

235 mm x 135 mm x 75 mm for mounted transport bracket: 235 mm x 193 mm x 207 mm

Conforming to standard

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IEC/DIN EN 60601-1

9.1

10.

Ambient conditions Operation

Temperature

Storage and transport

Disposal

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. Adhere to national regulations when disposing of or recycling the product, its components and its packaging! 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.

Relative humidity Atmospheric pressure

► Detailed information concerning the disposal of

the product is available through your national B. Braun/Aesculap agency, see Technical Service.

11.

Distributor in the US/Contact in Canada for product information and complaints

3773 Corporate Parkway Center Valley, PA, 18034, USA

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- DIR 93/42/EEC

Technical alterations reserved

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap – a B. Braun company

TA-Nr. 008142 Änd.-Nr. 46131

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