KaVo INTRAsurg 300, INTRAsurg 300 plus Instructions For Use Manual

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Instructions for use INTRAsurg 300 / INTRAsurg 300 plus

Always be on the safe side.

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Distributed by: KaVo Dental GmbH Bismarckring 39 D-88400 Biberach Tel. +49 7351 56-0 Fax +49 7351 56-1488

Manufacturer: Kaltenbach & Voigt GmbH Bismarckring 39 D-88400 Biberach www.kavo.com

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Contents

1 User instructions ........................................................................................................................................ 3

1.1 User guide ......................................................................................................................................... 3

1.1.1 Symbols ................................................................................................................................ 3

1.2 Target group ...................................................................................................................................... 3

1.3 Service .............................................................................................................................................. 3

1.4 Warranty terms and conditions .......................................................................................................... 3

1.5 Transportation and storage ............................................................................................................... 4

1.5.1 Currently valid packaging regulations .................................................................................. 4

1.5.2 Damage in transit ................................................................................................................. 4

1.5.3 Information on the packaging: Storage and transportation .................................................. 5

2 Safety ........................................................................................................................................................ 7

2.1 Description of safety instructions ....................................................................................................... 7

2.1.1 Warning symbol .................................................................................................................... 7

2.1.2 Structure ............................................................................................................................... 7

2.1.3 Description of danger levels ................................................................................................. 7

2.2 Purpose – Proper use ........................................................................................................................ 7

2.2.1 Information on electromagnetic compatibility ....................................................................... 9

2.2.2 Risks from electromagnetic fields (implanted life-sustaining system) ................................ 10

2.2.3 Disposal of electronic and electrical devices ...................................................................... 10

2.3 Safety instructions ........................................................................................................................... 11

3 Product description .................................................................................................................................. 13

3.1 INTRAsurg 300/300 plus ................................................................................................................. 13

3.2 Controls ........................................................................................................................................... 14

3.3 Multifunctional foot control ............................................................................................................... 15

3.4 Rating plate for 300/300 plus .......................................................................................................... 16

3.5 Technical data for the 300/300 plus ................................................................................................ 16

4 First use ................................................................................................................................................... 18

4.1 Electrical connection ....................................................................................................................... 18

4.2 Unpacking ....................................................................................................................................... 19

4.3 Adjust the mains input voltage ........................................................................................................ 19

4.4 Mount the bottle holder and use the correct coolant container ...................................................... 21

4.5 Connect the surgery motor and coolant reservoir ........................................................................... 22

5 Operation ................................................................................................................................................. 25

5.1 Operation in general ........................................................................................................................ 25

5.1.1 Start up ............................................................................................................................... 25

5.2 Surgical motors ............................................................................................................................... 25

5.2.1 INTRA S 550 surgical motor ............................................................................................... 25

5.2.2 INTRA LUX SL 550 surgical motor .................................................................................... 26

5.2.3 Remove the handpiece or angle piece ............................................................................... 27

5.2.4 Start the motor .................................................................................................................... 27

5.3 Free use .......................................................................................................................................... 28

5.3.1 Parameters menu ............................................................................................................... 28

5.3.2 Set the torque limitation ...................................................................................................... 30

5.3.3 Preset the speed range ...................................................................................................... 30

5.3.4 Set the coolant flow ............................................................................................................ 31

5.3.5 Selecting the handpiece and contra-angle handpiece ....................................................... 32

5.3.6 Switching the direction of motor rotation ........................................................................... 33

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5.3.7 Rinsing function .................................................................................................................. 33

5.3.8 Surgical motor in free use .................................................................................................. 34

5.3.9 Request maximum torque .................................................................................................. 34

5.4 Program ........................................................................................................................................... 35

5.4.1 Start the program ............................................................................................................... 35

5.4.2 Switch forward step ............................................................................................................ 36

5.4.3 Go backward a step ........................................................................................................... 36

5.4.4 Set parameters ................................................................................................................... 36

5.4.5 Limit the number of steps ................................................................................................... 37

5.4.6 Setting up delivery status ................................................................................................... 38

5.4.7 Surgical motor in the program ............................................................................................ 38

5.4.8 Request maximum torque .................................................................................................. 39

5.5 Functions exclusively with the 300 plus program version ............................................................... 40

5.5.1 Recognition function ........................................................................................................... 40

5.5.2 Light functions .................................................................................................................... 42

5.5.3 Request maximum torque (free use) .................................................................................. 43

5.5.4 Request maximum torque (program) ................................................................................. 43

5.5.5 Recommended programming when setting a number of implants one after the other ....... 43

5.5.6 INTRAsurg calibration ........................................................................................................ 44

6 Preparation methods DIN EN ISO 17664 ................................................................................................ 46

6.1 Cleaning .......................................................................................................................................... 47

6.1.1 Machine cleaning ............................................................................................................... 47

6.1.2 Manual cleaning ................................................................................................................. 47

6.1.3 Rinse the hoses .................................................................................................................. 47

6.2 Disinfection ...................................................................................................................................... 49

6.2.1 Automated disinfection ....................................................................................................... 49

6.2.2 Manual disinfection ............................................................................................................. 49

6.2.3 Drying ................................................................................................................................. 50

6.2.4 Service, inspection and testing after preparation ............................................................... 50

6.3 Sterilisation in a steriliser in compliance with DIN EN 13060 .......................................................... 50

6.3.1 Packaging ........................................................................................................................... 51

6.3.2 Sterilisation ......................................................................................................................... 52

6.3.3 Storage ............................................................................................................................... 52

7 Troubleshooting ....................................................................................................................................... 53

7.1 Exchange the pump hose ................................................................................................................ 56

7.2 Exchange coolant hose ................................................................................................................... 57

7.2.1 Exchange the coolant hose from the handpiece or angle piece. ........................................ 58

7.2.2 Exchange the coolant hose in the motor hose ................................................................... 58

7.2.3 Disposable coolant hose .................................................................................................... 59

7.3 Device settings table ....................................................................................................................... 61

8 Accessories ............................................................................................................................................. 62

9 Details on electromagnetic compatibility ................................................................................................. 63

9.1 Guidelines and manufacturer's declaration - electromagnetic transmission ................................... 63

9.2 Guidelines and manufacturer's declaration - electromagnetic resistance to jamming ..................... 63

9.3 Guidelines and manufacturer's declaration - electromagnetic resistance to jamming ..................... 64

9.4 Recommended safe distance between portable and mobile HF telecommunications equipment

and the INTRAsurg 300 ................................................................................................................... 65

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1 User instructions

1.1 User guide

1.1.1 Symbols

Refer to chapter Safety/Warning

Important information for users and technicians

Thermodisinfectable

Sterilisable up to 135°C

CE mark (Communauté Européenne). A product with this mark meets the requirements of the relevant EC directives, i.e. the applicable standards in Europe. ESD warning plate

1.2 Target group

This document is for dentists and office personnel.

1.3 Service

Service hotline: +49 (0) 7351 56-2500 Service.Einrichtungen@kavo.com Please indicate the product serial number in all requests. Additional information can be obtained at: www.kavo.comAdditional information can be obtained at: www.kavo.com

1.4 Warranty terms and conditions

KaVo provides the end customer with a warranty that the product cited in the hand‐ over certificate will function properly and guarantees zero defects in the material or processing for a period of 12 months from data of purchase, subject to the following conditions: Upon justified complaints of flaws or a short delivery, KaVo will make good its war‐ ranty by replacing the product free of cost or repairing it according to the customer's wishes. Other claims of any nature whatsoever, in particular with respect to com‐ pensation, are excluded. In the event of default and gross negligence or intent, this shall only apply in the absence of mandatory legal regulations to the contrary. KaVo cannot be held liable for defects and their consequences due to natural wear, improper cleaning or maintenance, non-compliance with operating, maintenance or connection instructions, calcination or corrosion, contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with factory specifications.

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The warranty does not usually cover bulbs, glassware, rubber parts and the colour‐ fastness of plastics. Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third party are excluded from the warranty. Claims from this warranty can only be asserted when the transfer form (copy) be‐ longing to the product has been sent to KaVo, and the original can be presented by the operator or user.

1.5 Transportation and storage

1.5.1 Currently valid packaging regulations

Note

Only valid for the Federal Republic of Germany.

Properly dispose of and recycle the sales packaging, in accordance with the relevant packaging regulations, through waste management businesses or recycling com‐ panies that run a comprehensive return system. KaVo has licensed its sales pack‐ aging in accordance with this directive. Please conform with the regional, public waste-disposal system regulations.

1.5.2 Damage in transit

In Germany

If the packaging is visibly damaged on delivery, please proceed as follows:

1. The recipient of the package must record the loss or damage on the delivery receipt. The recipient and the representative of the shipping company must sign this delivery receipt.

2. Leave the product and packaging in the condition in which you received it.

3. Do not use the product.

4. Report the damage to the shipping company.

5. Report the damage to KaVo.

6. You must contact KaVo before returning a damaged product.

7. Send the signed delivery receipt to KaVo.

If the product is damaged but there was no discernable damage to the packaging upon delivery, proceed as follows:

1. Report the damage to the shipping company immediately and no later than 7 days after delivery.

2. Report the damage to KaVo.

3. Leave the product and packaging in the condition in which you received it.

4. Do not use a damaged product.

Note

Failure on the part of the recipient to comply with any of the above obligations will mean that the damage will be considered to have arisen following delivery (in accordance with ADSp. Art. 28).

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Outside Germany

Note

KaVo is not liable for damage arising from transportation. Immediately inspect the delivery after receipt!

If the packaging is visibly damaged on delivery, please proceed as follows:

1. The recipient of the package must record the loss or damage on the delivery receipt. The recipient and the representative of the shipping company must sign this delivery receipt. Without this evidence, the recipient will not be able to assert a claim for damages against the shipping company.

2. Leave the product and packaging in the condition in which you received it.

3. Do not use the product.

If the product is damaged but there was no discernable damage to the packaging upon delivery, proceed as follows:

1. Report the damage immediately or at least 7 days after the delivery to the de‐ livery company.

2. Leave the product and packaging in the condition in which you received it.

3. Do not use a damaged product.

Note

Failure on the part of the recipient to comply with any of the above obligations will mean that the damage will be considered to have arisen following delivery (in accordance with CMR law, Chapter 5, Art. 30).

1.5.3 Information on the packaging: Storage and transportation

Note

Please keep the packaging in case you need to return the product for servicing or repair.

The symbols printed on the outside are for transportation and storage, and have the following meaning:

Transport upright with the arrows pointing upwards

Fragile - protect against impact.

Protect from moisture.

Permissible stacking load

Temperature range

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Humidity

Air pressure

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2 Safety

2.1 Description of safety instructions

2.1.1 Warning symbol

Warning symbol

2.1.2 Structure

DANGER

The introduction describes the type and source of the danger. This section illustrates the potential consequences of non-observance.

▶ The optional step covers necessary measures for avoiding hazards.

2.1.3 Description of danger levels

Safety instructions with three hazard levels are used in this document for avoiding personal and property damage.

CAUTION

CAUTION indicates a hazardous situation that can cause damage to property, or mild or moderate physical harm.

WARNING

WARNING indicates a hazardous situation that can cause death or serious injury.

DANGER

DANGER indicates the maximum hazard level. indicates a hazardous situation that can di‐ rectly cause death or serious injury.

2.2 Purpose – Proper use

Note

Only the INTRAsurg 300plus with the IPX8 foot switch is permitted for use in op‐ erating rooms.

The ambient temperature must lie between +10℃ and +35℃. The relative humidity must be between 30% and 75%.

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This KaVo product is intended only for use in the field of dentistry, for surgery to expose and dissect oral tissue structures (such as the periodontal gap, gingiva, bone, the jaw, extractions and implantations). The product may not be used for a purpose for which it was not intended. "Proper use" includes following all the instructions for use and ensuring that all in‐ spections and service tasks are performed.

The overarching guidelines and/or national laws, national regulations and the rules of technology applicable to medical devices for start-up and use of the KaVo product for the intended purpose are to be applied and complied with.

The user must ensure that that the unit works properly and is in a satisfactory con‐ dition before each use.

During use, national legal regulations must be observed, in particular:

▪ the applicable health and safety regulations ▪ the applicable accident prevention regulations

Users have a duty to:

▪ Only use equipment that is operating correctly ▪ to protect himself, the patient and third parties from danger. ▪ to avoid contamination from the product

To guarantee constant readiness for use and maintenance of value of the KaVo product, the recommended annual servicing must be done. Yearly safety inspections are required.

KaVo recommends an annual service check. In this service check, the safety checks are performed according to

IEC 62353:2007

as well as calibration. The safety check involves the following tests: Visually inspect the medical device and accessories; check the ratings of fuses that are accessible from outside; pro‐ tective conductor check and leakage current measurements as per IEC 62353:2007; medical device function test with reference to accompanying docu‐ mentation.

Authorized to repair and service the KaVo product:

▪ Technicians with appropriate product training from KaVo branches ▪ Technicians of authorized dealers specially trained by KaVo

In Germany, operators, equipment managers and users are obliged to operate their equipment in accordance with the MPG regulations. The services encompass all the test tasks required in accordance with § 6 of the medical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV).

After servicing, manipulation or repair of the device, the device must be tested ac‐ cording to IEC 62353:2007 (state of the art) before it is used again.

Check the parameters of the device settings after servicing. Enter the service pa‐ rameters in the table on the last page.

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Note

The product must be cleaned and serviced according to instructions if it is not to be used for a long period.

Note

Any waste which is generated must be recycled or disposed of in a manner which is safe both for people and for the environment. This must be done in strict com‐ pliance with all applicable national regulations. Questions on proper disposal of the KaVo product can be answered by the KaVo branch.

Note

A recycling pass can be downloaded from www.kavo.com.

2.2.1 Information on electromagnetic compatibility

Conformance level: The immunity test levels required in IEC 60601 are met.

CAUTION

Damage from incorrect accessories The use of other accessories, transformers and lines than those indicated (with the exception of transformers and lines that KaVo sells as replacement parts for in‐ ternal components) can increase transmission or reduce the electromagnetic im‐ munity of the product.

▶ Only use accessories recommended by KaVo.

CAUTION

Interactions between devices Effect on proper use

▶ Do not use the device directly next to or stacked with other devices ▶ If it is necessary to use it next to or stacked with other devices, check for proper

use in this set up.

Note

Based on EN 60601-1-2 concerning the electromagnetic compatibility of electro‐ medical devices, we need to point out that:

• medical electrical devices are subject to special measures regarding electromag‐ netic compatibility and must be operated in accordance with KaVo assembly in‐ structions.

• portable and mobile high-frequency communications devices can influence med‐ ical electronics.

Note

KaVo cannot guarantee that accessories, lines and transformers not delivered by KaVo will correspond with EMC requirements of EN 60601-1-2.

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2.2.2 Risks from electromagnetic fields (implanted life-sustaining system)

DANGER

Risks from electromagnetic fields. The functions of implanted systems (such as pacemakers) can be influenced by electromagnetic fields.

▶ Patients and users must inquire about implanted systems before using the

motors and check the use. ▶ Evaluate the risks and benefits. ▶ Do not bring the motors close to the systems. ▶ Take suitable emergency precautions and immediately react to any changes

in health. ▶ Symptoms such as elevated heart beat, irregular pulse and dizziness are signs

of problems with a pacemaker.

2.2.3 Disposal of electronic and electrical devices

Note

According to EC directive 2002/96 concerning used electrical and electronic devi‐ ces, this product is subject to the cited directive and must be disposed of accord‐ ingly within Europe. Before disassembling / disposing of the product, it must be completely processed (disinfected, sterilized) according to the section "Preparation methods" Additional information can be obtained from KaVo (www.kavo.com) or your dental supplier.

For final disposal, contact:

Germany

To return an electrical device, proceed as follows:

1. At the homepage www.enretec.de of enretec GmbH, you can download a form for a disposal request under the menu item eom, or you can use it as an online

request.

2. Fill out the request with the corresponding information, and send it as an online request or by fax (+49(0)3304 3919 590) to enretec GmbH. The following avenues are also available for questions and for initiating a dis‐ posal request: Telephone: +49 (0) 3304 3919 500 E-mail: pickup@eomRECYCLING.com and Post: enretec GmbH, eomRECYCLING Department Kanalstraße 17 16727 Velten

3. Yourmovabledevice will be picked up in your practice, and yourpermanently in‐ stalledunit will be picked up at the curb at your address on the agreed deadline. The owner or user of the device will bear the costs for disassembly, transporta‐ tion and packaging.

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International (EU)

For country-specific information on disposal, contact your dental supplier.

2.3 Safety instructions

CAUTION

Electrical sparks in the product Explosion.

▶ Do not use product in areas subject an explosion hazard.

CAUTION

Damaged network cable/missing protective conductor. Electrical shock.

▶ Check the network cable before use. The socket outlet must have a protective

contact and meet the respective national guidelines.

▶ Always completely inset the power cable into the device's socket to connect to

the mains.

CAUTION

Damage due to liquids Faults on electric components.

▶ Protect product openings from penetration of liquids. ▶ Remove liquids from the inside of the device.

CAUTION

Unintended penetration of liquids. Electrical shock.

▶ Do not immerse the product in a tub-like container.

▶ Check and make sure that the coolant containers and lines do not leak before

each use. If liquid is found on the device, do not touch it and disconnect the power cable from the mains. Completely dry the surface of the unit before re‐ inserting the power cable.

CAUTION

Damage to the instrument hoses from stickers. Instrument hoses can explode.

▶ Do not affix stickers or adhesive tape.

CAUTION

Rotating parts while the pump is operating Injury

▶ Do not stick anything in the pump. Turn off the device when the pump is open.

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CAUTION

Risks from electromagnetic fields. The functions of implanted systems (such as pacemakers) can be influenced by electromagnetic fields.

▶ Ask patients before treatment!

CAUTION

Electrostatic charge. Destruction of electronic components.

▶ Before contacting the hose coupling, touch the bottle holder with your hand to

release static electricity.

KaVo recommends that only original KaVo parts® be used for operating and repairs since their safety, operation and specific suitability have been tested in extensive tests.

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3 Product description

3.1 INTRAsurg 300/300 plus

① Controls ⑤ Surgical hose coupling ② Bottle holder ⑥ Motor holder ③ Unlocking the pump mechanics ⑦ Surgery motor ④ Hose pump ⑧ Multifunctional foot control

The KaVo INTRAsurg 300 plus has an additional lighting function and recognition function for the INTRA CL light, hand and contra-angle handpiece.

Note

Additional information on surgery and implantology can be obtained at: www.ka‐ vo.com

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3.2 Controls

A Program button B Parameter button C Minus button D Plus button E Enter button

① Step (1... 6) ② Transfer ratio of the handpiece and

contra-angle handpiece ③ Speed (rpm) ④ Direction of rotation (< - / - >) ⑤ Coolant pump setting (1... 6) ⑥ Maximum torque (Ncm)

PRG

Open the program. Use the PRG button to open the steps; repress the button to switch to free use.

Parame ter

Open setting mode. And Use the parameter button to select changeable parame‐ ters. Press the parameter button until the asterisk (*) flashes at the desired position. Changeable parameters:

- max. torque

- max. speed

- coolant pump setting

- Transfer ratio of the handpiece and contra-angle handpiece

- Direction of motor rotation

Reduce * value.

Increase * value.

Enter button: Save set of values/leave setting mode INTRAsurg 300 Plus: Request maximum torque.

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Note

The motor can only be started after you leave the setting mode by pressing the ENTER button. This saves all the changes. Only after this is done is the motor released to start.

3.3 Multifunctional foot control

(W) Shift pedal (Y) Hinged pedal (X) Right button (Z) Left button

Shift pedal W: Move forward for the default counter-clockwise rotation of the surgical motor Only with the INTRAsurg 300 Plus: The light can be switched on/off by moving to the left, and the spot light can be turned on by moving to the right.

Right button X: Procedural step button for selections in the program and for advancing the individual steps. Press briefly = proceed forward; press for a long time = proceed backwards. Double-click = open selection. An acoustic signal confirms proceeding forward/ backward when the motor starts.

Hinged pedal Y: Footswitch to start the motor and control its speed, and to start withdrawing the coolant without the motor running and then and then regulate the amount conveyed. The process is started by pressing the pedal down. The intensity is decreased by pressing the pedal to the left, and increased by pressing it to the right.

Note

Always check the input values before each use.

Left button Z: Coolant button to turn the coolant on/off and select rinsing without the motor.

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3.4 Rating plate for 300/300 plus

Installation side and securing the mains input

CE mark

VDE mark

CSA mark

Classification, type BF

Follow instructions for use

Mode: Continuous operation with intermittent load

Supply voltage

SN: YYYY = Year manufactured

XXXXXXX = Serial number REF: Material number Type: Device type

For disposal information, see use in accordance with intended purpose

GOST R certification

3.5 Technical data for the 300/300 plus

Width 291 mm

Depth 306 mm

Height 126 mm

Weight of the device 6.85 kg

Weight of foot control 2.35 kg

Weight of motor approx. 170 g

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Input voltage 100 V∼/120 V∼/230 V∼

Input frequency 50/60 Hz

Power consumption Max. 260 VA

True power Approximately 7 Watt

Speed 300 – 40000 rpm

Pump delivery rate 25 – 150 ml/min

delivery pressure 1.5 – 2.2 bar

Multifunctional foot control Protection class IPX1

Only KaVo INTRAsurg 300 Plus: Multifunctional foot control, identifica‐ tion: blue FBE stirrup, rating plate. Per‐ missible in surgery rooms.

Protection class IPX8

Standard-length hose for the multifunc‐ tional foot control

1.90 m

Special-length hose for the multifunc‐ tional foot control Only available with the INTRAsurg 300plus.

3.5 m

Standard motor hose length Mat. no. 1.001.2651

2.00 m

Special length motor hose Mat. no. 1.004.6825

3.0 m

Mode continuous operation duty type

30 sec. operation/ 9 min.sec pause

The torque precision of the KaVo angle piece 27:1 (TRA C09 + C3) ranges from 20 to 30 Ncm at 20 to 50 rpm. Greater deviations are possible with oth‐ er angle pieces.

± 3 Ncm

Transportation and storage conditions

Ambient temperature -20℃ to +70℃

Relative humidity 5% to 95%

Air pressure 700 hPa to 1060 hPa

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4 First use

4.1 Electrical connection

CAUTION

Damaged network cable/missing protective conductor. Electrical shock.

▶ Check the network cable before use. The socket outlet must have a protective

contact and meet the respective national guidelines.

▶ Always completely inset the power cable into the device's socket to connect to

the mains.

Both lines L and N are individually fused with T 3.15 H. The network frequency can be 50 or 60 Hz.

Requirement Make sure that the supply voltage is correct.

▶ First plug the inlet connector for non-heating apparatuses into the device, and

then plug the other end of the line into a socket.

See also: 4.3 Adjust the mains input voltage, Page 19

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4.2 Unpacking

Note

Do not kink the motor hose since it may damage it.

Note

Save the box with all the packaging materials so that the device can be safely shipped (for example for a yearly service check). Always send both hose boxes so that the device can be safely packaged to prevent damage.

Prevent damage by properly removing from the package.

▶ Open box. ▶ Remove the hose box. Remove the multifunctional foot control and additional

equipment.

Note

When removing, note that the multifunctional foot control is tightly connected to the device.

▶ Pull out the INTRAsurg 300/300 plus vertically upward and place on a flat sur‐

face.

4.3 Adjust the mains input voltage

CAUTION

Voltage-conducting parts Electrical shock.

▶ Unplug the power cable from the power supply.

A country-specific mains input voltage (a rating play) is set at the plant. Check the setting and change it if necessary to the existing mains input voltage. The voltage selector ① can be set to 100V, 120V or 230V. The existing setting can be read at the cutout ④.

Remove the drawer ③. Remove the fuse holder ② from the fuse drawer ③, and turn it so that the required voltage value appears in the cutout ④.

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Shove the fuse holder② back in the drawer ③. Insert the drawer ③ in the device. A code protects the drawer from being incorrectly inserted.

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4.4 Mount the bottle holder and use the correct coolant container

▶ Plug-in the bottle holder ①Mat. no. 0.761.1872 and rotate it until the bottle holder

faces away from the device and always secure with screw ②Mat. no. 1.005.8527.

CAUTION

Tipping danger from excessively heavy coolant reservoir Malfunctions

▶ Do not use coolant reservoirs that can hold more than 1 litre! ▶ Ensure that the device is standing securely.

In the case of glass bottles, insert an aeration needle. Otherwise, the supplied amount decreases with prolonged removal of coolant.

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WARNING

Electric shock due to coolant ingress Injuries

▶ Rotate the bottle holder away from the device to ensure that no leaking coolant

drips on the device or the electrical connection.

4.5 Connect the surgery motor and coolant reservoir

Note

The delivered parts are not sterile. Sterilise them before the first patient treatment. All parts conducting liquids must be sterilised.

▶ Plug in the surgery motor ⑥ at these surgery hose coupling and tighten with a

union nut ⑤. Follow the separate instructions for use for the motor.

▶ Place the surgery motor on the motor holder ①.

Note

The kink-protection part on the coolant hose inlet may not be twisted. Twisting the kink protection can cause defects in the house and lead to a restriction of coolant flow and causes the coolant to drip afterwards.

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ESD symbol

CAUTION

Electrostatic charge. Destruction of electronic components.

▶ Before contacting the hose coupling, touch the bottle holder with your hand to

release static electricity.

▶ Insert the hose coupling ② into the device connection until it audibly locks into

place and the marking ring on the plug is covered.

▶ Shove the coolant hose ④ onto the plug-in nipple ③ by twisting slightly.

▶ Open the pump mechanics by lifting the lock ⑧.

Note

Insert the pump hose into the pump so that it is not clamped or pinched by the lock. Run all hoses relaxed without tension. Shove the hoses firmly on the plug-in nipple to ensure a tight connection.

▶ Close the lock ⑧ in the direction of the arrow.

▶ Insert the insertion needle ⑨ into the coolant reservoir, and hang the coolant

reservoir on the bottle holder. Check the seal and seat of the insertion tip. Pre‐ vent fluid from exiting the device.

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CAUTION

Tipping danger from excessively heavy coolant reservoir Malfunctions

▶ Do not use coolant reservoirs that can hold more than 1 litre! ▶ Ensure that the device is standing securely.

Insert a sterile ventilation needle into glass bottles. The flow will otherwise be re‐ duced if coolant is withdrawn for a long period. Check the level of the coolant res‐ ervoir several times after waiting a while. The system must be leak-free. No liquid may escape from the coolant hose or the side of the connections.

Note

The saline solution corrodes all the metal parts. Immediately remove residue.

▶ Fasten the self-adhesive cable clip ⑦ Mat. no. 1.001.3348 to the INTRAsurg

300/300 plus (for the location, see the illustration).

▶ Insert the coolant hose ④ into the cable clip and close.

Note

Always monitor the level of the coolant reservoir. The device itself does not monitor the level. Use transparent coolant reservoirs.

If the product is used on potentially infectious patients, use disposable products for supplying coolant and thorough infection protection. KaVo recommends using a sterile disposable protective hose over the motor and hose (approx. 1.2 m) and a transparent disposable protective film over the device. The control buttons and dis‐ play must always be identifiable for operation.

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5 Operation

5.1 Operation in general

5.1.1 Start up

CAUTION

Product damage from incorrectly adjusting the tension. Destruction of electrical components.

▶ Adjust the voltage input for the product to the existing mains voltage.

▶ Switch on the device.

An acoustic signal confirms that the device is turned on. The device runs a self test. The firmware version and note "Please check parameters" is briefly shown on the display.

▶ Note the displays.

If the device is not monitored, we recommend turning it off for safety reasons and to save energy.

Note

The last saved values are displayed.

5.2 Surgical motors

CAUTION

Incorrectly set parameters Damage from incorrect input values

▶ Check all input values before use.

Note

Following instructions for use, service instructions and installation instructions in the motor, handpiece and contra-angle handpiece packaging.

5.2.1 INTRA S 550 surgical motor

▶ Plug straight or contra-angle handpiece onto the motor coupling. ▶ Check secure seat before each treatment.

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▶ Attach coolant hose.

5.2.2 INTRA LUX SL 550 surgical motor

Note

The INTRAsurg 300 plus has a recognition function for INTRA CL light, hand and contra-angle handpieces. Handpiece and contra-angle handpiece-specific param‐ eters are automatically transferred. Check all input values before use.

Mount the handpiece or angle piece

CAUTION

Heat transferred from high-pressure. Burns from touching the high-pressure lamp.

▶ Only operate the motor with the retention ring ① mounted.

▶ Place the INTRA CL light, hand and contra-angle handpiece on the surgery

motor and turn it until the catch audibly locks in place.

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CAUTION

Damage from changing the handpiece and angle piece during operation. Wear to the catch on the handpiece and angle piece and the motor Unbalanced motor axis.

▶ Change the handpiece and angle piece only when the motor not running.

CAUTION

Damage from operating with open chucks The handpiece or angle piece locks and rotates on its own axis.

▶ Only operate the handpiece or angle piece when the chuck is locked.

5.2.3 Remove the handpiece or angle piece

CAUTION

Damage from changing the handpiece and angle piece during operation. Wear to the catch on the handpiece and angle piece and the motor Unbalanced motor axis.

▶ Change the handpiece and angle piece only when the motor not running.

Note

Prevent to coolant hose from dripping on the motor. Coolant may not penetrate the motor.

▶ Remove the coolant hose from the handpiece or angle piece.

▶ Twist the handpiece or contra-angle handpiece slightly while pulling it off.

See also: 5.3 Free use, Page 28

CAUTION

Incorrect use. danger of injury.

▶ Always check the values before use.

5.4.5 Limit the number of steps

Six steps are saved upon first start up and after setting up the delivery status.

Example: Limiting the steps

The number of steps should be limited to four.

▶ Select step 4 ①.

PRG

▶ Press the program button for at least three seconds.

An acoustic signal confirms the entry.

Note

Now only the first four steps can be selected. When you continue to step 4, the message END appears.

If you continue, you go to free use.

Remove restriction

▶ Select the last step ① (4 in this example).

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PRG

▶ Press the program button for at least three seconds.

An acoustic signal confirms the entry.

5.4.6 Setting up delivery status

Note

All entries and changes made are deleted with this function.

Note

If the device was initialised, everything saved previously is deleted. Therefore, for simplicity, everything that was saved should be noted down for easy recovery.

PRG

▶ Turn device on while pressing the programme button.

After initialization, the device is ready for use in its condition at the time of de‐ livery.

Condition at the time of delivery: Programme

Step Instrument Speed (rpm) Torque

(Ncm)

Pump Direction of

motor rota‐

tion 1 27:1 11-1500 55 4 -> 2 27:1 11-50 40 4 -> 3 27:1 11-50 40 4 -> 4 27:1 11-50 40 4 -> 5 27:1 11-50 55 0 -< 6 27:1 11-50 10 0 ->

Condition at the time of delivery: Free application

Step Instrument Speed (rpm) Torque

(Ncm)

Pump Direction of

motor rota‐

tion 27:1 11-1500 55 4 ->

5.4.7 Surgical motor in the program

Requirement The mounted INTRA CL light, hand and contra-angle handpiece must be selected on the display.

If the mounted handpiece or contra-angle handpiece is not selected, the device asks for the corresponding input.

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if the motor is turned on without the corresponding entry, three acoustic signals sound, and the read-in instrument flashes on the device display with question marks, for example: ?27:1? .

Note

The motor will not start (safety circuit). To start the motor, either the selected handpiece or contra-angle handpiece must be mounted, or the mounted handpiece or contra-angle handpiece must be saved using the ENTER button.

Save the light, hand and contra-angle handpieces (without the moun‐ ted and peace and contra-angle handpiece)

Parame ter

▶ Press the parameter button until the asterisk flashes at the transfer ratio.

▶ Set the correct parameters with the Plus or Minus button.

▶ Save the set values with the enter button.

The data are now saved in this step.

5.4.8 Request maximum torque

The maximum torque is saved when you advance a step. When the motor is started in the next step, the highest torque is always saved.

▶ Press the enter button after closing the program.

In each step ①, the max. torque ② is shown in the display.

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▶ To leave the display, press the enter button.

All saved torques are deleted.

Note

If you leave the program buy pressing the plus button or the right button on the multifunctional foot control, all torques are deleted. If you accidently go too far and skip the torque display, the values can be reactivated and displayed by pressing the right button on the multifunctional foot control.

5.5 Functions exclusively with the 300 plus program version

Additional functions of the INTRAsurg 300 plus with an INTRA LUX SL550 motor:

▪ Light function. ▪ IPX8 multifunction foot control (blue stirrup, rating plate). ▪ Recognition of the INTRA CL light, hand and angle piece. The transfer ratio and

associated values are shown on the display.

▪ The user can perform additional calibration with the INTRAsurg Calibration

1.002.3569. (27:1 angle piece is required)

▪ Display of the maximum torques. The maximum torque is saved in each step.

The max. torque can be read on the display during surgery or after the program ends (only with clockwise rotation).

▪ Read-out table for the torque values at the end of applications.

5.5.1 Recognition function

Note

To prevent misinformation, the contact's provided for recognition always need to be regularly cleaned on the motor and instrument pusher. The contacts always must be shiny. Wipe off the contacts with a cloth soaked in disinfectant and rub dry.

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▶ Place the INTRA CL light, hand and angle handpiece on the INTRA LUX SL 550

motor and turn it until the catch ① audibly locks in place.

The hand and angle piece is recognised, and the corresponding saved parameters are shown on the device display ②.

CAUTION

Incorrect input values. Danger of injury.

▶ The input values must be checked before each use.

These parameters are immediately activated in free use.

The recognised handpiece or angle piece must be selected in the program. If it is not selected, the device asks for the corresponding input. Three acoustic warning signals sound, and the read-in instrument flashes on the device display with a ques‐ tion mark, for example: ?27:1?

Note

For safety reasons, the motor does not start (safety circuit) since the input value on the display always has priority.

▶ Check the parameters. Values displayed by the device can be saved by pressing

the ENTER button.

The data of the mounted INTRA CL light, hand and angle piece are only saved in this step. The motor starts with these released parameters.

Note

This must be done for the saved parameters to be reliably maintained and contin‐ uously followed.

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5.5.2 Light functions

Place the INTRA CL light, hand and contra-angle handpiece on the INTRA LUX SL 550 motor and turn it until the catch audibly locks in place. The INTRA CL light, hand and contra-angle handpiece is recognised and the corresponding parameters ap‐ pear on the display (this function is only possible with the INTRA CL light, hand and contra-angle handpiece).

Light on/off without motor and pump running (spot)

▶ Move the shift pedal to the right.

The light only shines when actuated (spotlight function).

Default light when the motor starts

▶ Move the shift pedal to the left.

The light is turned on or off. When the light is turned on, the following appears in the display: LUX (this function is only possible with INTRA CL light, handpieces and contra-angle handpieces).

Note

If there is no light function, check if the light is turned on and if the INTRA CL light, hand and contra-angle handpiece is properly mounted.

Afterglow time

The light shines for 3 sec. after the motor stops running.

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Note

The motor can only operate with retention ring ①Mat. no. 1.001.5029.

Note

Only the light function is activated and a 1:1 hand and angle piece is displayed with hand and angle pieces with a metal snap-in button. The torque is not displayed.

5.5.3 Request maximum torque (free use)

▶ Hold down the enter button after the motor stops.

The maximum torque ① of the last motor operation is displayed in Ncm.

Note

The torques are overwritten when the motor restarts under a minimum load of 5 Ncm.

5.5.4 Request maximum torque (program)

See also: 5.4.8 Request maximum torque, Page 39

5.5.5 Recommended programming when setting a number of im‐ plants one after the other

Mode of operation: Perform all tasks for drilling an implant in Free use mode. Screw in the respective implant in PRG steps (max. 6). At the end of the task, the torque screw-in value can be requested and manually documented for evaluating primary stability (in the form of the following table, for example).

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Step Instrument Speed (rpm) Torque

(Ncm)

Pump Motor r/l

1 27:1 11 – 50 40 0 -> 2 27:1 11 – 50 40 0 -> 3 27:1 11 – 50 40 0 -> 4 27:1 11 – 50 40 0 -> 5 27:1 11 – 50 40 0 -> 6 27:1 11 – 50 40 0 ->

5.5.6 INTRAsurg calibration

The influence of the efficiency of the instruments is taken into account when testing the torque display. Store the INTRAsurg calibration device at 15°C to 30°C to provide precise calibra‐ tion. The calibration value refers to the temperature of the INTRAsurg calibration of 23°C. If this temperature is not maintained, the value needs to be corrected ac‐ cording to table. For example: Calibration at 20°C (read 15.2) results in a corrected input value (+0.3) of 15.5.

Tempera‐ ture

15℃ 16℃ 17℃ 18℃ 19℃ 20℃ 21℃ 22℃ 23℃ 24℃ 25℃ 26℃ 27℃ 28℃ 29℃ 30℃

correc‐ tion

+0.8 +0.7 +0.6 +0.5 +0.4 +0.3 +0.2 +0.1 0 -0.1 -0.2 -0.3 -0.4 -0.5 -0.6 -0.7

A sterile instrument can also be used for calibration. To prevent contamination, use a sterile catch pin.

Note

The INTRAsurg Calibration system can be disinfected.

▶ Pre-position cleaned and set up angle piece 27:1 and INTRAsurg Calibration

Mat. no. 1.002.3569.

▶ Press the parameter button for 3 seconds.

The following message appears on the display:

▶ Read the calibration affixed to the bottom of the INTRAsurg Calibration (such as

15.2), correct the value according to the temperature, and enter with the Plus and Minus keys.

▶ Confirm with the enter button.

▶ Insert the catch pin into the INTRAsurg Calibration. ▶ Place the INTRAsurg Calibration on a fixed base and hold.

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▶ Start the motor. The motor always rotates to the right.

Note

Do not apply any pressure. The motor may not experience any additional load.

The process can be monitored on the display.

After calibration, the following appears on the display:

If calibration is unsuccessful, the following appears on the display:

Note

The output values are retained in case of interruption or error.

The calibration automatically ends. The INTRAsurg 300 plus is ready with the new setting.

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6 Preparation methods DIN EN ISO 17664

Note

Before preparations, follow the instructions for use of the surgery motor, handpie‐ ces and contra-angle handpieces, and the scaler SONICflex and special tools (bone). The instructions for cleaning and sterilisation have been validated by the manu‐ facturer. Any deviation from the provided instructions by the person preparing the device should be checked to see if it is effective, and potential negative conse‐ quences should be evaluated. Sufficient safety that prevents microorganisms that have entered the instruments from becoming a possible cause of infection is only provided by carefully process‐ ing the outside and inner surfaces directly after use. The handpieces and angle pieces must be packaged and sterilised and sterile when used. If potentially infectious liquids and particles can contact the products, it is recom‐ mendable to cover and protect these areas with sterile disposable products. Frequent preparation with proper use does not significantly affect the unit and mo‐ tor. The product life normally ends due to wear and damage from use. Observe all manufacturer instructions. Treat KaVo gently when cleaning them. Remove deposits such as saline coolant residue, blood and saliva with a disposable cloth immediately after use. Only use fully functional products for treating patients. Observe all current national hygiene regulations. See also www.rki.de (infection protection)

Note

A German language CD on hygienic measures in medical practices is obtainable from: MEDIEN & Forum, Am Brunnen 8, 29229 CELLE – Tel. D 05141/370188/89. E-mail: hammer@medien-information-bildung.de. Additional information can be obtained at: www.rki.de

Site of use

Remove moisture-sensitive parts close to the disinfection site. The treatment sur‐ faces of the area should be hygienically smooth surfaces. Protect difficult to clean surfaces and objects from contamination by covering them.

Preparation for decontamination

▪ Wear suitable protective clothing. ▪ Wear eye protection. No eating, drinking or smoking. ▪ Disinfect hands properly. ▪ Turn off the device and unplug it. ▪ Prepare and follow a hygiene plan. ▪ Only use disinfectants suitable for this group of devices. ▪ Prepare the parts suitable for sterilisation: Care, rinsing and packaging. ▪ Use qualified trained personnel for preparing dental equipment and instruments.

Train the personnel according to these instructions for use Plan and provide a schedule.

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6.1 Cleaning

Always clean directly after using the medical device to prevent contaminants from hardening. Saline solution contains sodium chloride which corrodes metal. Quickly remove all residue to prevent surface damage.

6.1.1 Machine cleaning

Not applicable for INTRAsurg device parts.

CAUTION

Damage due to liquids Faults in electric components.

▶ Do not machine-clean the INTRAsurg device.

6.1.2 Manual cleaning

▶ Wipe off the supply unit (all visible surfaces), motor hose, motor holder, bottle

container, foot control surfaces and the connecting lines with a damp disposable cloth. Do not wipe the cloth on edges and press so that liquid will not penetrate. Remove all residue and dry the device.

Note

After uses that run the risk of infection, rinse the coolant lines of the handpieces and contra-angle handpieces with a disinfectant (approx. 20 ml) with a disposable syringe. Avoid damage. Rinse the coolant lines with demineralised water, then drain and dry them.

6.1.3 Rinse the hoses

Preparation for product decontamination: Directly after each use, rinse all the hoses to prevent malfunctions from the crys‐ tallisation of the saline solution. All of the hoses must be completely emptied. Then sterilise them and observe the hygienic requirements for storage and maintaining sterility.

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▶ Remove the pump hose needle from the coolant reservoir. Immerse the pump

hose needle in a clean container with demineralised water (50-60 ml). Place the spray hose from the instrument in an empty container or sink.

Note

Rinse until all the hoses are drained. Do not immerse the water outlet into the liquid. Observe the necessary measures for infection protection.

▶ Press left button 3 sec. The rinsing function is selected.

See also: 5.3.7 Rinsing function, Page 33

▶ The rinsing function is shown in the display.

▶ Hold down slide pedal and slide it to the right until the stop. The hose pump runs

at the max. rate.

▶ Ensure that the water jet is in the right direction and that it is the right amount.

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▶ Press the left button briefly.

You exit the rinsing menu.

6.2 Disinfection

Note

The motor and motor hose cannot be thermodisinfected. After treating each patient, disinfect the surfaces close to the patient that are contaminated by contact or aer‐ osols. Wipe disinfection should be used in all cases.

6.2.1 Automated disinfection

Not applicable for INTRAsurg device parts.

6.2.2 Manual disinfection

▶ Pull the insertion needle ③ out of the coolant reservoir ②. ▶ Open the lock ① and remove the hose ④.

▶ Remove all hoses marked gray including tips and surgical motor on the unit. ▶ Wipe-disinfect surfaces with a soft, disposable cloth and permissible disinfec‐

tants. Make sure that the device is completely wet. Let the disinfectant act for the prescribed time. Dry the surface.

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Permissible disinfectants (the uses correspond to the existing manufacturer's in‐ structions and national guidelines. observe the safety data sheets.) KaVo recom‐ mends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufacturer.

▪ Incidin Liquid (Ecolab) ▪ FD 322 Dürr ▪ Schülke & Mayr Microcide ▪ Isopropanol 70%

6.2.3 Drying

▶ After disinfection and sterilisation: Let the surfaces and plug-in parts for the ho‐

ses and cables (contacts) completely dry in the room before they are used again.

6.2.4 Service, inspection and testing after preparation

▶ Test of cleanliness and intactness, care, repair: check the hose connections for

ease of plugging and secure attachment. Check the function of device settings and motor operation. Check hose pump for sufficient coolant. Check secure at‐ tachment of hose connections. Check control commands on foot control. Check recognition function of INTRAsurg 300 plus. Comply with hygiene requirements (sterility) during the check. If there are any sites of breakage or clearly recog‐ nised changes on the surface, the parts must be checked by the Service.

6.3 Sterilisation in a steriliser in compliance with DIN EN 13060

CAUTION

Product damage due to improper sterilisation. Damage to the sterile product.

▶ No hot air sterilisation, no chemical cold sterilisation, do not sterilise with eth‐

ylene oxide!

CAUTION

Product damage due to improper sterilisation. Damage to the sterile product.

▶ An initial vacuum can shorten the product life.

CAUTION

Moisture Non-sterility

▶ Ensure dryness. Autoclaves with a subsequent vacuum ensure dryness. In

addition, drying can be accelerated with a 10 minute drying phase with the autoclave door open.

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CAUTION

Product damage Contact corrosion

▶ Remove the sterilised item from the autoclave immediately after sterilising and

drying.

CAUTION

Crystallising saline solution Malfunctions

▶ Rinse all hoses and drain them completely before they are sterilised.

Note

The user is responsible for observing the regulations and conditions for sterility. After each patient, dispose of the coolant reservoir, rinse the hoses, and completely drain and sterilise them.

Note

When treating patients who may have an acute, critical infectious disease, be sure to observe the hygienic measures cited in applicable publications and reports. If possible, use suitable disposable products to avoid the transmission of critical pathogens. These protect the user, the patient and all participants in the surgery. A microbiologically appropriate coolant liquid must be used. Only use prescribed isotonic saline solution E NaCl 0.9 (identified as an infusion solution; follow the instructions on the package insert) for cooling and spraying wounds. All materials that are contaminated from the dental and medical fields must suitably processed and sufficiently identified after cleaning and sterilisation (RKI recommendation, www.rki.de).

See also: 6.1.3 Rinse the hoses, Page 47

The KaVo medical devices released for sterilisation have a maximum temperature resistance of 138 ℃.

6.3.1 Packaging

The sterilisation bag must be large enough for the items to be sterilised so that the bag is not stretched. The quality and use of the packaging of the items to be sterilised must satisfy the applicable standards and be appropriate for sterilising.

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▶ Wind all hoses previously cleaned and disinfected that are marked grey including

tips and the surgical motor on the motor holder ⑥. Seal the motor holder, handpieces and contra-angle handpieces in sterile bags or place them on a surgical tray.

6.3.2 Sterilisation

▶ Sterilise in saturated steam at 135±1℃, gravity, for at least 4 minutes.

Note

Let the sterilised materials cool and try to the ambient temperature before using them again.

6.3.3 Storage

Observe all necessary measures for hygiene when storing sterile goods. Store pro‐ tected from dust, release with identification on the packaging. Monitor storage length.

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7 Troubleshooting

Note

If your problem cannot be rectified after reading the following troubleshooting doc‐ umentation, please contact a KaVo-trained Service Technician.

In case of a problem, a fault number is displayed with: "warning xx" or "remark xx" Fault numbers 1 to 67 are possible.

Note

Confirm all other error messages with the ENTER button. If the error message does not disappear or the error is reported again, please notify customer service. Please always write down what you want or the service you want performed when you send in the device. The settings must be rechecked after the device is returned.

Malfunction Cause Remedy Nothing works. Fuse blown. ▶ Check and if necessary replace

the fuse.

The unit must be switched off. ▶ Turn on the mains switch on the

back of the unit.

Both ends of the power line are not plugged in.

▶ Plug in the mains power line:

The wrong handpiece or angle piece is mounted or set on the de‐ vice.

▶ Adjust the right handpiece or an‐

gle piece on the device.

Unknown. ▶ Turn the machine off and on.

No coolant in the instrument. Coolant flow not preselected. ▶ Set the coolant flow.

See also: 5.3.4 Set the coolant flow, Page 31

The pump hose is sticky or crusty. ▶ Exchange the pump hose.

KaVo INTRAsurg 300, INTRAsurg 300 plus Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual