ELAN-EC GA835 Instructions for Use Dec 2010

ELAN-EC

ELAN-EC

2. Table of symbols

Read these instructions for use carefully before putting the instrument into operation. This will enable you to avoid damage caused by improper assembly or operation and therefore not covered by the guarantee and warranty. We reserve the right to change design and technical data without prior notice.

Fig. 1: Fascia LED CCW operation LED CW operation Mains Off switch

1. Controls, symbols

Mains On switch LED Pump On (GA 835 only)

Fig. 1: Fascia 1 Flexible shaft connection 2 Flexible shaft sensor 3 LED CCW operation 4 LED CW operation 5 Mains Off switch 6 Mains On switch 7 LED Mains On 8 LED Pump On (GA 835 only) 9 Capacity control (GA 835 only) 10 Outlet to handpiece symbol (GA 835 only) 11 Inlet from irrigation bottle symbol (GA 835 only) 12 Irrigation pump (GA 835 only) 13 Lever (GA 835 only) 14 ELAN-EC logo

Outlet to handpiece symbol (GA 835 only) Inlet to irrigation bottle symbol (GA 835 only)

Fig. 2: Rear panel Connection for equipotential cable symbol Fuse symbol CE marking according to directive 93/42/EEC

Fig. 2: Rear panel 15 Flexible shaft support connection 16 Combined mains input incl. 2 fuses and mains voltage switch 17 Equipotential socket 18 Symbol Connection for equipotential cable 19 Fuse symbol 20 CE marking according to directive 93/42/EEC 21 Warning, read documentation! symbol 22 Type B application unit symbol 23 Rating plate 24 Ventilation grille 25 Control cable socket 26 Support bracket for sterile fluid bottle 27 Connection for sterile fluid bottle support bracket (GA 835 only)

Attention, see instructions for use Type B application symbol

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AC symbol Marking of electric and electronic devices according to directive 2002/96/EC (WEEE), see chapter Disposal.

3. Intended use When using a macro or micro flexible shaft, the electric surgical motor is suitable for driving a selection of Aesculap handpieces and may be used in macro (general) and micro surgery. The applied speed (max. 20,000 rpm) is dependent on the handpiece, the tool and the flexible shaft used. The unit complies with requirements for type B of IEC 601-1.

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4. Preparation, commissioning WARNING ¾ This unit is not suitable for operation in hazardous areas. The following regulations should be complied with for installation and operation of the unit – national installation and operating regulations – national fire and explosion protection regulations. ¾ Prior to commissioning the unit, examine whether the voltage stated on the combined power pack (Fig. 2, 16) of the unit agrees with the mains voltage. Operate electric surgical motors GA 830 and/or GA 835 with a. c. of 50–60 Hz only. The mains voltage should be between 100 and 120 VAC or between 220 and 240 VAC. Preset voltage range by combined power pack at rear of unit. See also para. 12.2. Connect mains cable (see Accessories) to correctly assembled mains socket only. The safety of both the user and the patient will also depend on the mains cable being intact, in particular the PE-conductor. Faulty or non-existent PE-conductors are often not recognised immediately. As an additional precaution it is therefore recommended to connect the unit by the equipotential socket at the rear of the unit (Fig. 2, 17) to the equipotential bonding of the room used for surgery. The required equipotential cable is available from the manufacturer as item GK 535 (4 m length) and/or GK 436 (0.8 m length).

4.1 Preparation prior to use The following steps should be completed prior to use: 4.1.1 GA 830 – ELAN-EC without a irrigation pump

4.1.2 GA 835 – ELAN-EC with a irrigation pump ¾ Proceed as for GA 830, see 4.1.1. ¾ Insert support bracket (Fig. 2, 26) into socket (Fig. 2, 27). ¾ Insert pump hose into irrigation pump: – Turn lever 13 in clockwise direction towards the irrigation bottle inlet symbol 11 until engaging with an audible click, see Fig. 4. – Insert pump hose and nipples in recess, see Fig. 4. – Turn lever 13 in counter-clockwise direction towards the outlet to handpiece 10 until engaging with an audible click, see Fig. 4. ¾ Transfer hose from flexible shaft to hose nipple at symbol 10. ¾ Connect hose with connecting spike and nipple at symbol 11. ¾ Pierce spike into cooling water bottle and suspend bottle from support bracket (Fig. 2, 26).

5. Inspection for proper function ¾ Prior to each use, subject electric surgical motor to a trial run outside a hazardous area and check for correct and reliable operation. For faults and remedies see para. 9.

5.1 Start-up The indicator (Fig. 1, 7) should be on after operating the Mains On switch (Fig. 1, 6).

5.2 Accessories ¾ Prior to preparation of accessories, check accessories for obvious damage to insulation and plugs and correct selection. ¾ Recognisable faulty items, in particular mains plugs and control cables, must be segregated without delay.

¾ Connect unit to mains by a mains cable. ¾ Connect control pedal cable to control cable socket (Fig. 2, 25) with an audible click. NOTE When connecting the pedal switch, ensure that the plug fits into the socket. When disconnecting the cable, press lat-chinglever whilst simultaneously disconnecting the plug from the socket (see Fig. 3). ¾ Push flexible shaft (suitable for sterilization) on to the flexible shaft connection until an audible click is heard (Fig. 1, 1). ¾ For disconnection withdraw flexible shaft sleeve and simultaneously disconnect flexible shaft (see operating instructions for flexible shaft). WARNING ¾ Connect and/or disconnect flexible shaft only when stopped, in order to avoid damage to coupling components of the motor and flexible shaft. ¾ The unit is equipped with an internal fan for cooling. Ensure that the ventilation slots (in side and rear wall) are not obstructed. ¾ Operate Mains On switch (Fig. 1, 6) (the indicator 7 is switched on). The unit is now ready for operation.

6. Mode of operation

6.1 General description Characteristics of unit The electric surgical motor GA 835 (GA 830) of clockwise/counterclock-wise rotation is used for driving a flexible shaft for a selection of Aesculap handpieces. The electronic control system allows infinitely variable speeds of max. 20,000 rpm by means of a control pedal (i. e. GA 188). This speed may be accurately controlled and kept constant in any range, even whilst subject to higher loads. The electric surgical motor GA 835 (GA 830) is equipped with a flexible shaft sensor. When using a macro flexible shaft, the motor will automatically switch to clockwise rotation, limiting its maximum speed to 15,000 rpm, not allowing counter-clockwise operation. When using a micro flexible shaft, operation in clockwise and counterclockwise direction is feasible. The maximum speed is 20,000 rpm. An audible signal is emitted when the unit is operated in counter-clockwise direction.

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NOTE For the above applications, the micro flexible shaft should be equipped with a flexible shaft sensor, i. e. flexible shafts (GA 173 to SN: 06984; GA 176 to SN: 13372) should be provided with a new sleeve (for disconnecting the flexible shaft from the unit). The new sleeve is marked by an all-round notch in the front third. Order by quoting item number GA 183 R. For micro flexible shafts without a sensor, the motor will automatically switch to clockwise rotation, limiting its maximum speed to 15,000 rpm – with counter-clockwise rotation being blocked. Flexible shafts GA 173 from SN: 06985 and GA 176 from SN: 13373 are standard shafts. When starting up the unit, a fan is enabled for ventilation. The electric surgical motor GA 835 is equipped with an integral cooling and irrigation system, enabled and disabled by means of a control pedal. The irrigation fluid capacity may be infinitely controlled by a rotary button (Fig. 1, 9). However, the pump will only run when the motor is enabled. The unit may be used for voltages of 100–120 VAC and/or 220–240 VAC (+/–10 %). For selection of voltages see chapter 12.2.

7. Safe operation

7.1 Start-up After correct connection of the control pedal, the electrical surgical motor may be started. After start-up, the electric surgical motor should rotate in counterclock-wise or clockwise direction when the micro flexible shaft is connected (see section 6.1), as selected. In case of counterclockwise rotation, an audible signal will be emitted. When a macro flexible shaft is connected, the motor will automatically lock counter-clockwise rotation in order to prevent damage to the flexible shaft. Should counter-clockwise rotation have been preselected by the control pedal, the electric surgical motor will ignore this setting. The clockwise LED (Fig. 1, 4) is on. The motor will only rotate in clockwise direction. Simultaneously, maximum speed is limited to 15,000 rpm.

8. Safety against incorrect operation NOTE Replace the flexible shaft, the handpiece and tools only when the unit is switched off. ¾ When starting up by the Mains On switch, ensure that the control pedal is not operated.

9. Recognizing and remedying errors

Fault/Error

Reason

Possible cause

• Recognition ¾ Remedy

Motor not running (LEDs not on)

No voltage to equipment

Mains switch not connected

¾ Connect mains switch

Mains On switch set to Off

¾ Set Mains On switch to On

Mains cable faulty

¾ Request new main cable from manifacturer

Fuses blown

Faulty device

¾ Replace fuses to section 12.1

Fuses blow again

Faulty device

¾ Return to manufacturer for repair

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Fault/Error

Reason

Possible cause

• Recognition ¾ Remedy

Motor not running (LEDs on)

Motor faulty

Blocked motor

¾ Return to manufacturer for repair

Overload protection stopping motor

Temperature sensor interrupting power supply

• The motor again ready for operation after a cooling period

Internal fuse blown

• Inspect fuse ¾ Replace fuse by qualified staff and/or the manufacturer

Fuses blown again

Faulty components on circuit board

¾ Return to manufacturer for repair

No connection from device to control pedal

Control cable not connected

¾ Connect control cable see chapter 4.1

Faulty control cable

• Inspect by replacing the cable ¾ Request new control cable from manufacturer

Faulty plug

• Motor running with another control pedal ¾ Return to manufacturer for repair

Control pedal faulty

Faulty potentiometer Broken wire Motor failure due to load

Fuses blown

Incorrect fuses inserted

• Check fuses ¾ Replace fuses see chapter 12.1

Motor can no longer be controlled

Control pedal faulty

Potentiometer faulty

• Motor can be controlled with another control pedal ¾ Return to manufacturer for repair

Faulty equipment

Faulty components on circuit board

• Motor cannot be controlled with another control pedal ¾ Return to manufacturer for repair

Motor running only in clockwise direction when counter-clockwise direction is preset

Macro flexible shaft connected

• Only running in CW direction ¾ See chapter 6. Operation

Micro flexible shaft without an identification sleeve!

• Only running in clockwise direction • Limitation of speed to 15,000 rpm ¾ Replace sleeve against new sleeve GA 183 R

Faulty flexible shaft sensor

Handpiece not running

Handpiece blocked or faulty

Faulty flexible shaft

Flexible shaft running inconsistently, out-of-round

Faulty sensor

Faulty flexible shaft

• Only running in clockwise direction • Limitation of speed to 15,000 rpm ¾ Return to manufacturer for repair • Motor and flexible shaft running without a handpiece ¾ Return to manufacturer for repair

Shaft jammed

• Motor only running when flexible shaft removed ¾ Return to manufacturer for repair

Broken shaft, conductor or dog

• Motor running when flexible shaft is connected ¾ Return to manufacturer for repair

Kinks in flexible shaft, worn-out bearings

• High running noises, rattling ¾ Return to manufacturer for repair

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ELAN-EC

Fault/Error

Reason

No coolant

Irrigation pump not running Note: Irrigation pump only running when motor is started

Irrigation pump not running Note: Irrigation pump only running when motor is started

Blocked jet

• Irrigation pump running ¾ Clean jet

Hose incorrectly inserted

• Lever 13 not engaged and/or in bottle position ¾ Insert hose to section 4.1.2

Leaking hose

¾ Replace hose set

No voltage to irrigation pump

Irrigation pump motor faulty

Faulty electronic system

• Irrigation pump not running when: – Control pedal is activated – Irrigation pump is on (indicator 8, Fig. 1 on) – Motor is started – Irrigation pump output >> 0 ¾ Return to manufacturer for repair

Faulty control pedal

• Motor running with another control pedal ¾ Return to manufacturer for repair

Irrigation pump not running with another control pedal

• Irrigation pump not running when: – Control pedal is activated – Irrigation pump is on (indicator 8, Fig. 1 on) – Motor is started – Irrigation pump output >> 0 ¾ Return to manufacturer for repair

10. Care and handling

10.1 Unit WARNING ¾ Remove plug from mains socket prior to cleaning! Do not use flammable or explosive agents. Fluid must not penetrate into equipment. Use approved surface disinfectant for cleaning and disinfection, see DGHM disinfectant list. Disinfection by wiping is recommended. ¾ Wipe off detergent, disinfectant and dirt with a clean sponge or cloth moistened with clean water, followed by drying with a cloth.

10.2 Accessories See instructions for each item.

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• Recognition ¾ Remedy

Possible cause

11. Service, service intervals The electric surgical motor GA 835 (GA 830) does not require any servicing. ¾ Regularly perform functional tests to section 5. ¾ Regularly inspect accessories (see instructions for use of the accessories). The mains cable in particular should be inspected for possible damage to the insulation. Inspection may only be entrusted to persons able to correctly perform inspections and not requiring any instructions due to their training, know-how and practical experience. Maintenance Your warranty shall become null and void when the equipment is opened by unauthorised persons. Aesculap shall only be responsible for any effects on safety, reliability and output of the equipment under the following circumstances: • when assembly, extensions, readjustments, servicing, repairs or modifications are effected by persons authorised by Aesculap; • when the electrical installation of the appropriate rooms complies with applicable regulations and • when the equipment is used in compliance with operating instructions. For repairs use original Aesculap spare parts only.

ELAN-EC

For amendments or maintenance of the electrical system of the device, the maintenance engineer should be requested to issue a certificate stating type and scope of the repair including details relating to any amendment of nominal data or the working range. In addition, the certificate should include the date of completion, the name and signature of the company. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-2700 Fax: +49 7461 16-2887 E-mail: [email protected] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, MO 63042 Aesculap Repair Hotline Phone: +1 800 214-3392 Fax: +1 314 895-4420 Other service addresses can be obtained from the address indicated above.

12.2 Presetting voltages (see Fig. 5) ¾ Prior to starting up the equipment, compare voltage of combined power pack at rear of equipment with your actual mains voltage. The equipment is preset to 230 V on delivery. Should the voltage indicated not agree with your actual mains voltage, change preset voltage. ¾ Release tab by a suitable screwdriver and pull out drawer 3. Release voltage setting mechanism 2 by a screwdriver and withdraw. Replace voltage setting mechanism when the mains voltage agrees with the visible marking. Insert drawer 3 into combined power pack 1 with an audible click. Labelling

Voltage range

110 V

100–120 V ~ (+/– 10%)

230 V

220–240 V ~ (+/– 10%)

13. Combination and stacking of units When stacking and/or assembling the electric surgical motor, do not obstruct ventilation slots in cover of casing and at rear of unit.

13.1 Stacking of units (see Fig. 6)

12. Replacement of fuses and presetting voltages WARNING ¾ Disconnect plug from socket prior to replacing the fuse and presetting the voltage!

12.1 Replacement of fuses (see Fig. 5) ¾ Release tab by a suitable screwdriver and pull out drawer 3. ¾ Replace fuses and push in drawer until the combined power pack 1 engages with an audible click. WARNING ¾ Use type G fuse-links, slow-acting (T) 4.0 A, breaking capacity L (L = 40 A at 250 V / 50 Hz) fuses only! These fuse links may be obtained from the manufacturer by quoting item No. TA 020 436. Should fuses blow frequently, this must be due to an internal fault in the equipment. ¾ Return equipment to manufacturer or an authorised service centre for maintenance.

¾ Ensure that a stacking height of 475 mm is not exceeded and the support (a table, ceiling lights, etc.) is sufficiently stable. ¾ Dismantle feet of top unit by a screwdriver. ¾ Remove caps D from stacking cones C. ¾ Position top unit congruent, thus allowing the two stacking cones C to engage in the stacking recesses A by exerting additional downward pressure. ¾ Should the top unit not engage, rotate threaded bar B with a screwdriver in counter-clockwise direction to stop, followed by positioning the unit again congruently. ¾ Then secure unit by rotating the threaded bar B with a screwdriver in clockwise direction to stop. ¾ Check by lifting slightly whether the stack is securely connected and ensure full stability of the unit.

13.2 Disassembly of stacks (see Fig. 6) ¾ Stacks may be separated by rotating the threaded bar B with a screw-driver in counter-clockwise direction to the stop. ¾ Then remove top unit, reassemble feet and attach caps to stacking cones C.

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14. Technical data Type of equipment

GA 835

Voltage ranges

100 V–120 V and 220 V–240 V

Frequency

50–60 Hz

Power input

2.5 A at 110 V~ 1.3 A at 230V~

Irrigation pump capacity

variable from 0–max. 80 ml/min. (based on nominal voltage)

Protection class

1

Equipment fuse Switching capacity

T 4.0 A 40 A bei 250 V / 50 Hz

Weight

Approx. 7.9 kg

Dimensions (W x T x D)

305 mm x 305 mm x 125 mm

Applied to section

Type B

Spark protection

IEC 601-1-2

Standard applied

IEC 601-1

GA 830

Approx. 7.3 kg

CE marking according to directive 93/42/EEC

15. General recommendations and advice

15.1 Application guidelines to IEC/VDE regulations The following notes have been based on presently applicable IEC/VDE regulations: • This unit is not suitable for operation in hazardous areas. • However, its control pedal circuit is Ex-rated and approved for operation in a medical environment to IEC 601/VDE 0750.

16. Accessories WARNING Use Aesculap products for accessories only. For detailed information of accessories see ELAN-E catalogue O-079. Use accessories listed in this catalogue only. The use of other accessories will require prior approval by the manufacturer. Mains cables

15.2 Unintentional start-up of motor WARNING Unintentional start-up of an electric surgical motor may cause injury when the handpiece (including a tool) is directly attached by the patient or the operator. Unintentional start-up of an electric surgical motor may be caused by the following: • unintentional operation of control pedal • short-circuit in a cable to control pedal • faulty equipment In order to reliably prevent injury due to unintentional start-up of an electric surgical motor, the following rules should be complied with in each case: ¾ Never lay down the handpiece on or close to a patient ¾ Do not hold tools

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Color

Length

Item No.

Europe

Black

1.5 m

TE 780

5.0 m

TE 730

Switzerland, Liechtenstein

Black

2.5 m

TE 781

5.0 m

TE 731

UK

Black

2.5 m

TE 784

5.0 m

TE 734

USA, Canada, Japan

Grey

1.5 m

TE 785

3.5 m

TE 735

ELAN-EC

17. Spare parts

Equipotential cable Length

Item No.

4.0 m

GK 535

0.8 m

GK 436

For repairs use original spare parts only.

18. Disposal

Flexible shaft

Macro flexible shaft (Comfort-line) Micro flexible shaft

Length

Item No.

1.6 m

GA 156

2.1 m

GA 172

1.6 m

GB 400

2.1 m

GB 401

1.8 m

GA 176

2.3 m

GA 173

Sleeve for retrofitting of micro flexible shaft with GA 183 R a flexible shaft sensor

Note Always adhere to national regulations when disposing of or recycling the product or its components! Products carrying this symbol are subject to separate collection of electric and electronic devices. Within the European Union, disposal is carried out without fees by the manufacturer.

If you have any questions concerning the disposal of the product, please contact your national B. Braun/Aesculap agency.

GA 173 to SN: 06984 (inclusive) GA 176 to SN: 13372 (inclusive)

Control pedal

GA 188 GD 411 GA 139 GA 136

Hose set

GA 240 GA 385

19. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 USA

GA 391 Oil

GA 59 GA 149 (oil spray)

Mobile stand

GA 415 U (for USA/Canada only) GA 415 (all other countries)

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