elcomed 100 Instructions for Use

Contents Intended use ... 3 Qualifications of the user ... 4 Production according to EC Directive ... 4 Important notes ... 5 - 6 Brief information ... 7 Responsibility of the manufacturer ... 8 - 9 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Supply schedule ... 10 - 11 Classification of the elcomed system ... 12 Explanation of pictograms and symbols ... 13 Operating notes ... 14 Technical description ... 15 - 20 Make connections, connect bur and milling cutter drives, check functions... 21 - 24 Commencing operation... 25 - 38 Error messages ... 39 Disinfection, cleaning, sterilization ... 40 - 44 For special attention ... 45 Supply sources for spare parts, disposable articles and consumables .. 46 - 48 Training certificate Warranty card 2

Intended use Drive unit for surgical transmission instruments with coupling system according to DIN 13.940 / ISO 3964 and the correct functions according to regulations: - mechanical drive and - supply with coolant

WARNING!

It is essential that you comply with the instructions of the manufacturers of surgical transmission instruments and all rotating instruments, burs, milling cutters, saw blades etc. used in surgery with regard to maximum speed, maximum torque, clockwise and anti-clockwise running. Use only suitable and serviceable tools. In order to prevent the danger of over-heating an area of treatment, the coolant flow must be adjusted as appropriate to requirements. Whether and how much coolant flow is to be used is determined by treatment requirements and the experience of the surgeon.

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Qualifications of the user The elcomed surgical units may only be used by medically, technically and practically trained and educated personnel who have been trained in the functions of the W&H elcomed unit. We have focused on "physicians" as the target group in the development and design of the elcomed unit. In particular, we regard dental surgeons involved in implantology as well as physicians specializing in oral and facial surgery as our target group.

Production according to EC Directive The EC Directive 93/42/EEC was applied in the design and manufacture of this medical product and applies to the elcomed 100 surgical unit (Type 9925) and to the elcomed 200 surgical unit (Type 9926), in the condition as supplied by us. This declaration does not apply to attachments, extensions etc. for which there is no provision.

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Important notes Due to possible interference with cardiac pacemaker function by magnetic fields from the elcomed motor, we give below the appraisal by the Austrian Testing and Research Institute for Biomedical Technology, Graz: "The use of elcomed dental drilling unit is associated with the generation of magnetic fields, which even in the most unfavourable conditions are below the interference immunity limit according to EN 50061 Ad1 by an approximate factor of 100. Under worst-case conditions, i.e. with the least favourable implantation and the most sensitive, i.e. atrium-controlled, cardiac pacemakers, the magnetic fields generated under normal operating conditions are just below the interference limit. When the switched-on handpiece is brought close to the site of implantation, reversible but definite influencing of the pacemaker function can be expected. However, this is of shorter duration than normal operation. As the unit is basically designed only for short periods of operation of not more than 45 s, no serious damage to the patient is to be expected, even under the most unfavourable conditions."

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Suitability

The surgical motors No. 02813500 and No. 02814000 along with foot-operated speed regulator No. 00990600 correspond to Class AP according to EN 60601-1 in danger zone M.

The foot-operated speed regulator is water-tight according to IP X8 (watertight according to IEC 529).

WARNING!

The control unit of the elcomed system is not intended for use in explosion hazarded danger areas M and G, i.e. the control unit must not be used in danger zones M and G according to DIN-EN 60601-1.

Stopping the motor

The motor stops when the foot-operated speed regulator pedal is no longer actuated.

Improper use

Improper use or dismantling of the unit or otherwise non-compliance with our instructions relieves us of any claims under warranty or other claims! Dismantling must be undertaken only by authorized W&H service engineers! 6

Brief information The electronically controlled elcomed system offers functional reliability in implantology and surgery. The simple but reliable operation of the system reduces the unavoidable risks during surgery.

For your safety and the safety of your patients

The instructions explains to the user how to handle our W&H product. We must, however, warn of possible dangerous situations. Your safety and the safety of your team and of course the safety of your patients are of paramount importance to us.

For this reason, it is necessary to comply with the following instructions. WARNING!

Only fit transmission instruments onto the surgical motor when the motor is not running! (Risk of damaging the motor and instruments!) Never touch rotating burs or cutters! (Risk of injury!) Never operate the chucking mechanism of the contra-angle or straight handpieces while the motor is running! (Risk of damage!)

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Responsibility of the manufacturer W&H Dentalwerk Bürmoos, as manufacturers of the elcomed system, can only be responsible for the safety, reliability and performance of the unit when the following instructions are observed:

Assembly, modifications and repairs shall be performed only by those persons specifically authorized to do so.

The electrical installation in the room must comply with the ÖVE-EN 7 regulations ("Installation of electrical equipment in rooms used for medical purposes") resp. the regulations applicable in your country.

The elcomed 100 unit Type 9925 SPS, 220-240 V, 110-130 V resp. 100 V, is listed under registration number 0583-012-ff of the "Österreichischer Verband für Elektrotechnik" (ÖVE = Austrian Electrical Engineering Association) and is entitled to bear the ÖVE test symbol. Furthermore a CSA-labelled version is available which is listed under registration number LR 105544-1 of the "Canadian Standards Association" and is entitled to bear the CSA NRTL/C symbol. 8

The unit shall be used in accordance with the Instructions for use. The warranty and any warranty claims are invalidated by the unauthorized opening of the equipment seal.

System failure

A total system failure of the elcomed unit is not a critical failure within the meaning of DIN 55350-31.

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1. Supply schedule The standard equipment includes: ❍ Electronic control unit 220-240 V alternatively: ❍ Electronic control unit 110-130 V alternatively: ❍ Electronic control unit 100 V ❍ Foot-operated speed controller No. 00990600 (220-240 V resp. 110-130 V) el co 10

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❍ Motor with 1.8 m cable No. 02813500 ❍ Pump hose cpl. No. 02802200 ❍ Set of pump hoses (qty. 5) No. 02801500 ❍ Set of hose rings (qty. 10) No. 02801000 ❍ Initial supply of coolant hoses (qty. 10) No. 00929300 Fig.: Type 100 (illustration does not show the standard equipment)

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❍ 2 replacement fuses No. 01199100, 2 A slow-blow, 250 V (220-240 V) alternatively: ❍ 2 replacement fuses No. 01199200, 4 A slow-blow, 250 V (110-130 V resp. 100 V) ❍ Pack of sterile transparent bags No. 02802400 ❍ Mains supply lead No. 01343700 (220-240 V) alternatively: ❍ Mains supply lead No. 01343900 (110-130 V resp. 100 V) alternatively: ❍ Mains supply lead No. 02821400 (110-130 V CSA) ❍ Stand No. 02802000 ❍ Tray No. 02802500 ❍ 2 Handpiece holders No. 02821500 alternatively: ❍ Motor with 3.5 m cable, No. 02814000 ❍ Coolant hoses (qty. 10) for 3.5 m cables No. 00929400

Note

Use only original W&H spare parts and consumables (see pages 46 to 48).

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2. Classification of the elcomed system Classification of the elcomed system according to § 5 of the general specifications for the safety of medical electrical equipment according to ÖVE-MG/ EN 60.601-1/ff. § 5.1.

Protective Class I equipment.

§ 5.2.

Type BF equipment.

§ 5.3.

The control unit of the elcomed system is graded as "standard equipment" (closed equipment without protection against the ingress of water).

§ 5.4.

Approved disinfection and sterilization method (see pages 40 to 44).

§ 5.5.

The control unit of the elcomed system is not suitable for use in explosive atmospheres or in explosive mixtures of anesthetic agents with oxygen or nitrous oxide (danger zones M and G). Motor and foot-operated speed controller are approved for use in Zone M (AP).

§ 5.6.

Equipment for continuous duty with intermittent loading.

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3. Explanation of pictograms and symbols Caution, see accompanying documents. Class AP equipment according to EN 60601-1. Applies to complete surgical motor, No. 02813500 (cable length 1.8 m) or No. 02814000 (cable length 3.5 m) respectively and foot-operated speed controller No. 00990600. Connection for equipotential bonding.

Type BF equipment (degree of protection against electric shock) according to EN 60601-1. The elcomed unit must not be used for intracardiac application.

Symbol for foot-operated speed controller.

S6 45s/10min

Operating mode S 6 (see page 14). 13

4. Operating notes For use in the operating theatre as a Class AP equipment and for autoclaving up to 135 °C, cooling slots and ventilation apertures of the enclosed motor have been omitted. For this reason, the motor heats up according to loading and speed. Thermal cut-out

When a temperature threshold is exceeded, a preliminary warning is given: a beep tone three times together with simultaneous flashing of the display. The flashing continues until either a lower value is reached or until the unit automatically switches off the motor because of excessively high motor temperature. The display shows the message "motor hot - OFF + wait 10 min". After a cooling period, the equipment can be used again.

Operating mode S6

Design of the elcomed 100 unit: S6 45s/10min = continuous duty with intermittent loading. With a current input of 0.5 A (with coolant pump), the permitted relative loading time is 45 seconds to 10 minutes running time (according to IEC Publication 34-1 [1983] "Rotating electrical machines. Part 1: Rating and performance").

45s/10min

Behaviour in the event of short-period power failure

Motor stops, display disappears. For safety reasons, we advise you to release the foot-operated speed controller. When power returns, a beep tone will sound once. The setting used immediately prior to the power failure will be activated. 14

5. Technical description 5.1 Technical data

Supply voltage:

220 - 240 V AC 110 - 130 V AC 100 V AC

Permissible voltage deviation: Frequency:

50 - 60 Hz

Rated current:

2 A (220-240 V AC) 4 A (110-130 V AC / 100 V AC)

Max. mechanical power output: Max. torque: Fuses:

± 10 %

350 W 10 Ncm

2 A slow-blow / 250 V / No. 01199100 (220-240 V AC) 4 A slow-blow / 250 V / No. 01199200 (110-130 V AC / 100 V AC)

Speed range: Operating mode: Dimensions (WxDxH):

200 - 50,000 rpm

S6 45s/10min = Continuous duty with intermittent loading (see page 14) 310 mm x 290 mm x 105 mm 15

5.2 Description of front panel Type 100

Keys

Programming keys for three adjustable configurations.

Minus key

For changing the speed settings respectively the corresponding values in combination with the keys % n:n %

Plus key

For changing the speed settings respectively the corresponding values in combination with the keys % n:n % 16

Key

On/off switch for torque limitation.

Key

Clockwise/anticlockwise rotating switching.

Key

On/off switch for the hose pump.

Key Ncm / %

Change of torque limitation.

Key n:n

Choice of transmission ratio.

Key %

Setting the pump flow rate.

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5.3 Description of the footoperated speed controller

green

yellow

The motor is started with the pedal. Smooth regulation up to the maximum speed selected. The motor stops when the foot-operated speed regulator pedal is no longer actuated. Green key:

1 x brief actuation causes the hose pump to switch on/off (corresponds to key ) 2 sec.actuation operates the keys in turn 18

Yellow key:

Clockwise/anticlockwise rotating switch (corresponds to key ) with intermediate position "motor OFF"

You can select the following functions with the yellow key, in which these can only be switched in turn. Assuming that clockwise running is selected:

Attention!

First actuation Second actuation

= =

Third actuation

=

Fourth actuation

=

Motor off Switch to anticlockwise - audible beep signal and visual display through flashing LED via key Motor off - indicated visually by flashing LED via key Switch to clockwise

If the power supply is interrupted or a switch is made to a different program in the position of "Motor off", the unit will store the motor speed "000". The motor speed must be increased again (key ).

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5.4 Description of the rear panel of the control unit ÖVE

Ni ch t fü No r de t all n Be ow ed to Be trieb be reich in us ex ed en plos in best io ex plosimmnsge ion t! fähr de en W&H ten DE da TY ng AUSTRDENTAL NTAL PE ered IA, 511WERK WERK FA area 1 BÜ BÜRM BR s! RM OO .N

OOS S Gm bH

R.

VO LT 50 -60 Hz

AM P U/m in

BE TR CL IEBS AS S OFART RA TING

S6

45s/ 10m in

max .

ON / OFF power switch Connection pin with for equipotential integrated bonding operating display Connection socket for footoperated speed controller

Mains socket and fuse holders with 2 fuses (No. 01199100, 2 A slow-blow, 220-240 V, both in use, resp. No. 01199200, 4 A slow-blow, 110-130 V / 100 V, both in use)

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