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.

3

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.

4

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."

5

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!)

7

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.

9

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

❍ ❍ ❍ ❍ ❍

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

0

Fig.: Type 100 (illustration does not show the standard equipment)

10

❍ 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).

11

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.

12

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 / %

Key n:n

Key %

Change of torque limitation.

Choice of transmission ratio.

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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6. Make connections, connect bur and milling cutter drives, check functions 6.1 Footoperated speed controller

Insert connection plug with spigot upwards into the connecting socket and secure with screw ring. 50

-60

Hz

AM P

BE TR CL IEBSA AS S OF RT RA TIN G 45

S6

U/m

in

s/10m

ma

x.

6.2 Mains supply lead

Plug the mains supply lead into the equipment socket provided (connect it to the power supply only later).

Nic No

ÖVE

t all

ht

ow

für ed

in

Connect footoperated speed controller.

de to

n Be Be trie be rei b in us chen explo ed in besti si ex p

W&H DE AUS DENTAL NTAL TRIA WER , 511 K 1B

-60

BE TR CL IEBSA AS S OF RT RA TIN

Hz

AM

S6

P U/mi

n

45s/1

G

0min

Plug in the mains supply lead.

6.3 Equipotential bonding according to DIN 42801-15

Where provided in the room, make the connection via the connecting pin of the elcomed unit to the equipotential bonding strip.

U

BE T CL RIEBS AS S O ART FR ATI N

S6

Connecting pin for equipotential bonding. 21

6.4 Connecting the pump hose

Fit the hose in the pump housing as shown in the illustration. The flat surfaces must engage in the slot to resist twisting. Fitting the hose in the pump housing.

6.5 Connecting the coolant

6.6 Connecting the coolant hose

The coolant bottle or bag and the sterile fittings can be obtained from a pharmacist. Ensure safe suspension, particularly when using coolant bottles! Connection is made with the flexible hose connection at the coupling connector of the pump hose.

Take a sterile coolant hose out of the packaging and fit the special coupling onto the pump hose connection. Tighten it with one clockwise rotation. Push the coolant hose into the fitted hose rings of the motor cable.

Connection of the coolant.

Connect coolant hose.

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6.7 Coupling the motor

Insert the plug-in coupling into the motor socket ensuring that the red marker dots line up. Plug-in coupling only; not screwed.

Motor coupling.

6.8 Uncoupling the motor

Uncouple the motor connector by pulling on the sleeve with the multicorner milling. Attention! Do not pull on the cable!

6.9 Connecting the mains supply lead

Connect only to the earthed contact socket.

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6.10 Connect bur and milling cutter drives

Connect the contra-angle or straight handpiece selected to the elcomed motor by pushing it on as far as it will go.

6.11 Check functions

Note the manufacturer's directions concerning permissible maximum speed, clockwise and anticlockwise running. Check the secure locking of the coupling system by rotating and pulling lightly on the contra-angle or straight handpiece inserted.

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7. Commencing operation 7.1 Display of factory settings

Press key and while pressing it set power switch to ON. Continue pressing key until the second, short beep tone is heard. This displays the factory settings such as motor speed, torque limitation, pump flow rate etc. On selecting keys

and

, their settings can be read off.

Switch off the unit and wait about 5 seconds. Press key and while pressing it set power switch to ON. Continue pressing key until the second, short beep tone is heard. This deletes the transmission ratios additionally stored as a test.

Deleting test settings

Test settings set during demonstration / training are simple to delete: Follow the steps according to section 7.1.

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7.2 Selecting display language

Press key

and while pressing it set power switch to ON.

A selection can be made from German, English, French, Italian and Spanish by pressing key . Select language required and confirm with key

.

Switch off the unit and wait about 5 seconds.

7.3 Selecting adjustment for motor cable length

Press key

and while pressing it set power switch to ON.

1.8 m or 3.5 m cable can be selected with key Select cable length required and actuate with key

("select"). .

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7.4 Displays (values in display)

After making factory settings according to section 7.1, the following values are shown on the display:

Selected, converted bur speed

Torque limitation (Ncm/%)

Step up / down ratio (n:n)

Pump loading (%)

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7.5 Using the keys

A selection can be made between three preset speeds with the relevant torque, the relevant transmission ratio and pump flow rate by pressing one of the three programming keys or . (Only possible when the motor is not running!) On switching between the programs or , the last values set are stored, i.e. the setting of a speed with torque and transmission ratio along with pump flow rate are not lost.

7.6 Speed change with plus / minus key

It is recommended to change the speed only when the motor is not running. Pressing key or respectively increases or reduces the motor speed by one step. Continuosly pressing key or activates the repeat function and the speed is increased or reduced more quickly. The speed can thus be increased up to the specified speed limit of 40,000 rpm. In order to overcome the speed limit intentionally and to move into the speed range of 50,000 rpm, the active program key , or must be pressed once in addition. When the unit is switched off /on, or in the event of a power failure, the values which were set above the speed limit are not stored but are reset to the speed limit of 40,000 rpm. When a different transmission ratio than 1:1 is set, the change in bur speed is automatically converted and displayed according to the transmission ratio.

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7.7 Torque limitation

The torque limitation can be switched on and off with key . When the torque limitation is switched off, the torque indication on the display is replaced with "MAX" and the LED above the key lights. The motor runs at 100 % of the available torque.

Caution! If the torque limitation is switched off by pressing the key , this applies to all three programming keys ( )! On pressing the key once more, the individual speeds are again assigned the set values of the torque limitation.

WARNING!

Fast deceleration of the bur can, at times cause the torque selected to be overloaded as a result of the rotational energy stored in the drive system. We therefore advise compliance with the individual manufacturer’s instructions for use, particularly when adjusting bridge screws. For safety reasons, these should be screwed in very carefully by hand, or by using a torque wrench. We would point out that adjusting these screws by an electric motor represents a potential risk as described above.

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7.8 Setting the torque limitation

Torque limitation must be switched on. LED is not lit. By continuously pressing or , the torque limitation the key Ncm / % and simultaneously pressing key is increased or reduced respectively. By continuously pressing key Ncm / % and

Ncm / %

key or , the repeat function is activated and the torque limitation is increased or reduced more quickly. The torque limitation can be adjusted separately for all three program keys. With the transmission ratios 10:1, 20:1 and 40:1, the torque limitation is displayed in Ncm values. The Ncm display is tailored to the use of W&H handpieces 10:1, 20:1 and 40:1. If different manufacture handpieces are used, the torque may deviate from the value displayed due to different efficiency. With all other transmission ratios, the values are displayed in %.

WARNING! When the correct torque limitation is set and visible on the display, it is essential to release key or before key Ncm / % , in order to prevent unintentional changing of the motor speed!

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7.9 Pump On / Off switch

The pump can be switched on or off by pressing the key . When the pump is switched on, the LED above the key lights. When the pump is switched off, the display shows "OFF" above the key % .

Attention! When the pump is switched off by pressing the key , this applies to all three program keys ( )! Pressing the key once more actuates the pump again.

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7.10 Setting the coolant flow %

Key

must be actuated. LED illuminates. By continuously pressing the key % ,

and simultaneously pressing key or , the flow of coolant is increased or reduced respectively. Continuously pressing key % and key or activates the repeat function and the coolant flow is increased or decreased more quickly. The coolant flow can be adjusted separately for all three program keys.

WARNING! When the correct amount of coolant is set and visible on the display, it is essential to release key or before key % , in order to prevent unintentional changing of the motor speed!

Coolant

Comply with the manufacturer's medical data and instructions. At the same time ensure adequate suction at the operating site. Use only suitable coolant. The elcomed unit is designed for physiological saline.

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7.11 Motor clockwise/anticlockwise rotation

Clockwise or anticlockwise running is selected by pressing the key . When anticlockwise running is selected, the LED above the key flashes and an audible signal is heard at about one second intervals.

Attention! When clockwise or anticlockwise running is selected by pressing the key applies to all three program keys ( )!

, this

33

n:n

7.12 Changing the transmission ratio n:n

The transmission ratio is selected by continuously pressing the key and simultaneously pressing the key or . Continuously pressing key n:n and key or activates the repeat function and the transmission ratio is increased or reduced more quickly. The selection starts at 1000:1 step-down ratio and ranges up to a step-up ratio of 1:5 (in 20 standard steps). When the ratio is changed, the relevant speed is automatically converted. The transmission ratio can be set separately for all three program keys. If required, entry of any additional five ratios is possible at any time.

WARNING! When the correct transmission ratio is set and visible on the display, it is essential to release key or before key n:n , in order to prevent unintentional changing of the motor speed!

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7.13 Programming additional transmission ratio

Press key and while pressing it set the power switch to ON. Continue pressing the key until the second short beep tone is heard. This selects the programming mode. The selections appear on the display. You can select either step-down (XX:1) or step-up (1:XX) with the key . Actuate the function selected with the key .

Step-down XX:1

When step-down ratio is selected, the display shows "0000". The arrow is under the thousands place. By pressing the key , you can select "1" at the thousands place to provide a 1000:1 step-down ratio. Confirm the entry with key . The arrow will simultaneously jump to the hundreds place. The value can be increased or reduced with the key or respectively. Proceed in the same way as for the thousands place to set the hundreds, tens and units places. After selecting the place value, confirm each individual place with the key . After entry of the units place, confirm with key . Confirm once more and program the step-down ratio entered (theoretically 1999:1 possible) with the key . Pressing the key

allows entries to be cancelled.

35

Step-up 1:XX

When step-up ratio is selected, the display shows "0.0". The arrow is under the units place. By pressing the key or , you can select the units place from 1 to 5. Confirm the entry with key . The arrow will jump to the tens place. Only the value "0" or "5" can be set with the keys or . After entry of the tens place, confirm with key . Confirm once more and program the step-up ratio entered (theoretically 1:5.5 possible) with the key . Pressing the key

7.14 Deleting additionally programmed transmission ratios

allows entries to be cancelled.

If a wrong ratio has been entered and also confirmed with the key to delete this from the table. Switch off the unit and wait about 5 seconds. Press the key time set the power switch to ON. Continue pressing the key short beep tone sounds.

, it is possible

and at the same until the second

Attention! With this procedure, all previous additionally stored transmission ratios are deleted again! 36

7.15 Reselecting the factory settings

In order to be able to reselect the values entered in the factory, observe the following procedure: 1. Switch off the unit and wait about 5 seconds. 2. Press key and while pressing it set power switch to ON. Continue pressing key until the second short beep tone is heard. This restores the factory settings of the three program keys

7.16 Storing set values

Attention!

.

In the event of a power failure or when the unit is switched off or on changing between the program keys , all program values last set are stored for speed, torque limitation, transmission ratio and pump flow rate. Clockwise/anticlockwise running, torque limitation MAX and pump flow OFF apply to all three program keys and are also stored in the event of a power failure or when the instrument is switched off. When the unit is switched on again or when power is restored, these values are loaded again and work can continue with the set speeds, torques etc. The last program setting used is activated again. Speeds which were set above the speed limit of 40,000 rpm are not stored but are reset to the speed limit! 37

7.17 Speed too high

Check the set or selected speed immediately before starting surgery. Too high a speed can endanger you, your team and the patient.

7.18 Torque too high

Check the set or selected torque immediately before starting surgery. Too high a torque can endanger the patient.

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8. Error messages (indication on the displays) Control error - call service! There is a fault in the electronic circuitry. Please contact your dealer. Low voltage - switch OFF + ON Power failure in the feeder. Switch the unit off and then on. If error is signalled again, please contact your dealer. Power pack hot - OFF + wait 10 min Overtemperature in the unit. Switch off, wait 10 minutes and then switch on again. If the error is signalled again, please contact your dealer. Flashing display plus beep tone three times Motor overload. Preliminary warning of too high motor temperature. With a further increase in temperature, the motor will become hot - error message Motor hot OFF + wait 10 min Motor hot - OFF + wait 10 min Motor overload. The unit must be swiched off immediately for about 10 minutes (for cooling) or a second motor used. If the error occurs again, please contact your dealer. Memory full - n1=end The attempt has been made to store more than 5 additional transmission ratios. Clear the additional transmission ratios (see section 7.14, page 36). 39

9. Disinfection, cleaning, sterilization It is assumed in the use of this surgical unit that attention has been given to cleanliness and cleaning.

9.1 Disinfecting and cleaning the control unit

The control unit does not come into contact with the patient. Only external spray or wipe disinfection with microbiologically tested surface disinfectants or 80 % ethyl alcohol. Comply with the action time of the disinfectant used! The front panel of the control unit is appropriately sealed and can be wiped over.

9.2 Disinfecting and cleaning the footoperated speed controller

The foot-operated speed controller does not come into contact with the patient. External spray or wipe disinfection is possible as necessary according to section 9.1.

40

The elcomed motor with cable and the pump hose must be sterilized before use. For sterilization, use a transparent bag according to DIN 58953 Part 4 from one of the packages supplied No. 02802400. Do not use any bag which is damaged. min. 100 mm

04032600

▼

Attention! Do not kink the motor cable! Do not use a too tight radius when wrapping around the arm. In order to protect the internal parts of the motor during sterilization, insert the sterilization protection supplied into the motor attachment prior to sterilization! The motor bearings are lubricated for life and no subsequent lubrication or other maintenance is needed. The motor must not be dismantled!

▼

9.3 Sterilizing the elcomed motor with cable and pump hose

Insert sterilization protection into the motor attachment.

Note

The relevant standard ISO 11498 specifies a life of at least 250 sterilization cycles. Regular servicing of the motor and cable from W&H must be carried out only after 500 sterilizations.

WARNING!

After sterilization, do not immediately start using the cable again! Wait until the cable is absolutely dry. The moisture on the connector can otherwise cause an equipment malfunction! (Danger of short-circuit) 41

9.4 Sterilization of straight and contra-angle handpieces

All W&H straight and contra-angle handpieces can be sterilized up to 135 °C. In this respect, see the notes in separate operating instructions. Particularly important is the use of W&H SERVICE OIL for maintenance. Since this oil is sterilizable, no subsequent lubrication is then needed following sterilization.

9.5 Sterilization of stand, tray and handpiece holders

The stand, tray and handpiece holders are removable and must be sterilized before use.

Attention! Avoid excessive oiling of the transmission instruments! The back flow of oil can damage the motor!

42

9.6 Permitted sterilization methods

A) Steam sterilization (normal and fast sterilization) at: - 121 °C - 135 °C (preferably) - 143 °C We prescribe the use of the sterilization protection No. 4032600 (for the motor) and sterile goods packaging according to DIN 58953 Part 4. B) Sterilization in an chemiclave is permitted. We prescribe the use of the sterilization protection No. 04032600 (for the motor) and sterile goods packaging according to DIN 58953 Part 4. W&H recommend steam sterilization up to 135 °C.

9.7 Methods of sterilization not permitted

The following methods are n o t approved for the elcomed surgical unit: A) Hot air sterilization B) Cold chemical sterilization

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9.8 Sterility of the infusion fittings Attention!

The bag (or the bottle) containing the physiological salt solution and the fittings are available from pharmacists in sterile packaging. Handling of these items is subject to the same rules for infusions as in the medical field.

These fittings are not sterilizable. Do not reuse disposable articles!

9.9 Sterility of the coolant hoses

W&H provides an initial pack of 10 sterile packaged coolant hoses No. 00929300 or alternatively No. 00929400.

Attention!

These coolant hoses are disposable items and must be exchanged after every treatment. Please comply with the imprinted expiry date. In addition, please comply with the relevant regulations regarding the disposal of coolant hoses.

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10. For special attention 10.1 Regular inspection

Regular inspection of the function and safety of the unit is necessary. Inspection should be carried out at least once every three years if shorter intervals are not specified by statutory regulations. We recommend that this inspection should be performed by a specialist authorized by W&H.

10.2 Repairs

If defects occur, always send in the complete unit, since an inspection of the control electronics is also necessary in the event of a motor malfunction! Attention! Do not kink the motor cable! Do not wind the cable round the motor! Risk of damage!

10.3 Returning the unit

Always use the original packaging for dispatch and enclose the warranty card!

45

11. Supply sources for spare parts, disposable articles and consumables Note

Use only original W&H spare parts and consumables!

46

Spare parts

1) 00990600

Foot-operated speed controller (220-240 V / 110-130 V / 100 V)

2) 01199100

Slow-blow 2 A fuse 250 V (220-240 V) resp.

01199200

Slow-blow 4 A fuse 250 V (110-130 V / 100 V)

3) 04032600

Sterilization protection

4) 01343700

Mains supply lead (220-240 V) resp.

01343900

Mains supply lead (110-130 V / 100 V) resp.

02821400

Mains supply lead (110-130 V CSA)

5) 02801000

Set of hose rings (set of 10)

6) 02802000

Stand complete

7) 02802500

Tray

8) 02813500

Surgical motor (cable length 1.8 m), alternatively

02814000 9) 02821500 Suppliers:

Surgical motor (cable length 3.5 m) Handpiece holder (2 pcs.) W&H partners

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Consumables

Disposable articles

10) 02801500

Pump hose (set of 5)

11) 02802200

Pump hose

Suppliers:

W&H partners

12) 00929300

Initial supply of coolant hoses (10 in sterile packaging) for cable length 1.8 m, alternatively:

00929400

Initial supply of coolant hoses (10 in sterile packaging) for cable length 3.5 m

13) 02802400

Pack of sterile transparent bags (qty. 10)

Suppliers:

W&H partners

Coolant, infusion fittings Suppliers:

medical equipment suppliers, pharmacists (cannot be supplied by W&H) 48

ISO 9001 EN 46001

Manufacturer: W&H Dentalwerk Bürmoos GmbH Austria, A-5111 Bürmoos Postfach 1, Ignaz-Glaser-Straße 53

Telefon: +43 / 62 74 / 62 36-0 Telefax: +43 / 62 74 / 62 36-55 E-Mail: [email protected] www.wnhdent.com

Subject to alterations.

In other countries: CALL YOUR LOCAL DENTAL DEALER

Form-Nr. 5415 0109 AEN

In United Kingdom and Ireland: W&H (UK) LIMITED 6 Stroud Wood Business Centre Park Street, St. Albans Herts AL2 2NJ Telephone: 01727 / 87 49 90 Telefax: 01727 / 87 46 28 E-Mail: [email protected]

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